TESTREPORT EN60601-1 Medicalelectricalequipment Part1:Generalrequirementsforbasicsafetyandessentialperformance ReportReferenceNo........................: …

TERMOMETRO INFRAROJO DIGITAL DEALTA PRESICION DE NO CONTACTO CORPORAL

FICHA TÉCNICA

Vida Útil: Hasta 5 Años

Tiempo de medición: ‹5 Segundos

Fuente de Alimentación: 2 Baterías AAA

Rango de Medida: 32oC - 43oC

Margen de Error: (+) 0.2o C

Apagado Automático: 15 Segundos

Peso: 100 Gr

Temperatura de Trabajo: 10oC - 40oC

Tamaño: 160mmx100mmx40mm

Material: PC/PVC

Características: Alarma de temperatura en 3 colores

Certificaciones: CE, EMC, ROHS

* Las imágenes son de referencia, el producto fisico puede variar, se entrega sin baterías.

CARACTERÍSTICAS

TEST REPORTEN 60601-1

Medical electrical equipmentPart 1: General requirements for basic safety and essential performance

Report Reference No........................ : A20032641R-01

Tested by............................................. :Approved by ..................................... :Date of issue....................................... :

StevenLiuzeMar., 25, 2020

Total number of pages..................... : 139 pages

Name of Testing Laboratory...........: United Testing Technology (Hong Kong) Limited

Address................................................: Unit 04,7/F,Bright Way Tower,No.33 Mong Kok Road, Kowloon, HK.

Applicant’s name...............................: Henan BingZun Industrial Co., Ltd

Address................................................: 50 meters next to the south of Guihua Villa, Xin'an Industry ClusterDistrict, Luoyang City, Henan Province, China

Test specification:Standard.............................................. : EN 60601-1:2006+A1:2013+A12:2014,

EN 60601-1-11: 2015Test procedure................................... : LVD Report

Non-standard test method………..: N/A

Test Report Form No........................ : IEC60601_1P

Test Report Form Originator.......... : UNI

Master TRF.......................................... : 2019-10-11

This test report is for the customer shown above and their specific product only. It may not be duplicated orused in part without prior written consent from UNI lab.

General disclaimer:The test results presented in this report relate only to the object tested.

Page 2 of 140 Report No. A20032641R-01

Test item description.......................... : Non-contact Electronic Thermometer

Trade Mark............................................. : bingzun

Manufacturer......................................... : Henan BingZun Industrial Co., Ltd50 meters next to the south of Guihua Villa, Xin'an Industry ClusterDistrict, Luoyang City, Henan Province, China

Model/Type reference......................... : R3,R5,R6,R7,R8,R9,R11

Ratings....................................................: DC3.0V

Summary of testingTests performed (name of test and test clause):

The submitted samples were found to comply with requirements of standards:- EN 60601-1:2006+A1:2013+A12:2014,- EN 60601-1-11: 2015

Copy of marking plate

The artwork below may be only a draft. The use of certification marks on a product must beauthorized by the respective NCBs that own these marks.Non-contact Electronic ThermometerModel No.: R3Powered by: 2 x 1.5V AAA Batteries. 3Vd.c

Henan BingZun Industrial Co., Ltd

MADE IN CHINA


GENERAL INFORMATION

Test item particulars (see also Clause 6):Classification of installation and use......................................... : hand-held equipment

Device type (component/sub-assembly/ equipment/ system):Internal powered equipment

Intended use (Including type of patient, application location).: It measure the body temperature of themeasured object by collecting infraredheat radiation from the forehead of themeasured object.Its operation is simpleand hygienic, and the measurement is fastand accurate.The user only needs to pointthe probe head at the forehead and pressthe measurement button to measure thetemperature.Widely used in schools,customs, family, etc.

Mode of operation..........................................................................: Continuous / non-continuous

Supply connection......................................................................... internally powered 2 x AAA batteries usedin appliance

Accessories and detachable parts included.............................. : AAA batteries

Other options include.................................................................... : N/A

TestingDate of receipt of test item(s).......................................................: Mar. 20, 2020

Dates tests performed...................................................................: Mar. 20, 2020 ~ Mar. 25, 2020

Possible test case verdicts:- test case does not apply to the test object ............................ : N/A

- test object does meet the requirement.................................... : Pass (P)

- test object was not evaluated for the requirement................... : N/E (collateral standards only)

- test object does not meet the requirement..............................: Fail (F)

Abbreviations used in the report:- normal condition..................................................... : N.C. - single fault condition.................. : S.F.C.

- means of Operator protection ............................ : MOOP - means of Patient protection .... : MOPP

General remarks:Before starting to use the TRF please read carefully the 4 instructions pages at the end of thereport on how to complete the new version “K” of TRF for IEC for 60601-1 3rd edition withAmendment 1."(See Attachment #)" refers to additional information appended to the report."(See appended table)" refers to a table appended to the report.- The tests results presented in this report relate only to the object tested.- This report shall not be reproduced except in full without the written approval of the testing -laboratory.- List of test equipment must be kept on file and available for review.- Additional test data and/or information provided in the attachments to this report.


INSULATION DIAGRAM

TABLE: INSULATION DIAGRAM P

Pollution degree.......................................... : - —

Overvoltage category................................. : - —

Altitude.......................................................... : - —

Additional details on parts consideredas applied parts........................................... :

None Areas ________________(See Clause 4.6 for details)

—

AreaNumber andtype of Meansof Protection:MOOP, MOPP

CTI Workingvoltage

Requiredcreepage(mm)

Requiredclearance(mm)

Measuredcreepage(mm)

Measuredclearance(mm) Remarks

Vrms Vpk

A Double/2MOOP/2MOPP

3.0 - - 3.4 1.6 >4.0 >4.0 Livepart(Battery toplasticenclosure)

B Double/2MOOP/2MOPP

3.0 - - 3.4 1.6 >4.0 >4.0 Applied part tolivepart(battery)

C Basic - 250 - 4 2.5 >4.0 >4.0 Type BFApplied part toEnclosure

Supplementary Information:

INSULATION DIAGRAM CONVENTIONS and GUIDANCE:A measured value must be provided in the value columns for the device under evaluation. The symbol >(greater than sign) must not be used. Switch-mode power supplies must be re-evaluated in the device underevaluation therefore N/A must not be used with a generic statement that the component is certified.

Insulation diagram is a graphical representation of equipment insulation barriers, protective impedance andprotective earthing. If feasible, use the following conventions to generate the diagram:- All isolation barriers are identified by letters between separate parts of diagram, for example separatetransformerwindings, optocouplers, wire insulation, creepage and clearance distances.

- Parts connected to earth with large dots are protectively earthed. Other connections to earth are functional- Applied parts are extended beyond the equipment enclosure and terminated with an arrow.- Parts accessible to the operator only are extended outside of the enclosure but are not terminated with anarrow.


EN 60601-1

Clause Requirement + Test Result - Remark Verdict

4 GENERAL REQUIREMENTS P

4.1 Requirements of this standard applied inNORMAL USE and reasonably foreseeable misuse

P

4.2 RISK MANAGEMENT PROCESS FOR ME EQUIPMENT OR ME SYSTEMS P

4.2.2 General requirement for RISK MANAGEMENT -PROCESS complies with ISO14971 (2007)........... :

See Appended RM ResultsTable 4.2.2.

P

4.2.3 Evaluating RISK P

4.2.3.1 a) Compliance with the standard reducesresidual risk to an acceptable level

P

b) Manufacturer has defined risk acceptabilitycriteria in the RISK MANAGEMENT PLAN.................. :

RISK MANAGEMENT PLANDocument: _ See RiskManagement controlprocedure for medical Device_

P

c) When no specific technical requirementsprovided manufacturer has determined HAZARDSor HAZARDOUS SITUATIONS exists.

P

- HAZARDS or HAZARDOUS SITUATIONS have beenevaluated using the RISK MANAGEMENT PROCESS.

P

4.2.3.2 MANUFACTURER has addressed HAZARDS orHAZARDOUS SITUATIONS not specificallyaddressed in the IEC 60601-1 series.

P

4.3 Performance of clinical functions necessary toachieve iNTENDED USE or that could affect thesafety of the ME EQUIPMENT or ME SYSTEM wereidentified during RISK ANALYSIS.

RM File Reference toEssential performance: _SeeRisk Management Report_

P

- Performance limits were identified in bothNORMAL CONDITION and SINGLE FAULT CONDITION.

P

- Loss or degradation of performance beyondthe limits specified by the MANUFACTURER wereevaluated

P

- Functions with unacceptable risks areidentified as ESSENTIAL PERFORMANCE................. :

See Appended Table 4.3 P

- RISK CONTROLmeasures implemented P

- Methods used to verify the effectiveness ofRISK CONTROL measures implemented

P

4.4 EXPECTED SERVICE LIFE stated in RISKMANAGEMENT FILE..................................................... :

P

4.5 Alternative RISK CONTROL methods utilized: P


EN 60601-1


RESIDUAL RISK resulting from the alternativeRISK CONTROL measures or tests is acceptableand comparable to RESIDUAL RISK resultingfrom application of this standard.........................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

RMF Reference to specificrisks:

(ISO 14971 Cl. _See RiskManagement Report _)

P

Alternative means based scientific data orclinical opinion or comparative studies............ :

P

4.6 RISK MANAGEMENT PROCESS identifies parts thatcan come into contact with PATIENT but notdefined as APPLIED PARTS, subjected to therequirements for APPLIED PARTS, except forClause 7.2.10............................................................:

See Appended InsulationDiagram Table

P

MANUFACTURER assesses the risk of accessibleparts coming into contact with the patient..... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

RMF Reference to specificRISKS:(ISO 14971 Cl. _See RiskManagement Report _)

P

Assessment identified the APPLIED PART TYPErequirements............................................................:

Type B/BF/CF P

4.7 ME EQUIPMENT remained SINGLE FAULT SAFE, orthe RISK remained acceptable as determined byClause 4.2................................................................. :

P

MANUFACTURER RISK ANALYSIS was used todetermine failures to be tested...........................:(ISO 14971 Cl. 4.2-4.4)

RISK ANALYSIS reference:(ISO 14971 Cl._4.2 _)

P

Failure of any one component at a time thatcould result in a HAZARDOUS SITUATION, includingthose in 13.1, simulated physically ortheoretically ............................................................:

See appended Table 13.2 forsimulated physical test, orSee Attachment No. __ fortheoretical simulation

P

4.8 All components and wiring whose failure couldresult in a HAZARDOUS SITUATION used accordingto their applicable ratings, unless specified.... :

P

Components and wiring exception in thestandard or by RISK MANAGEMENT PROCESS

P

RISK MANAGEMENT PROCESS assessescomponents to identify components where thefailure results in a HAZARDOUS SITUATION forcomponents used outside their ratings...........:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

RMF Reference to specificRISKS:

(ISO 14971 Cl._4.2_)

P

MANUFACTURER identified components wherethe failure results in a HAZARDOUS SITUATION... :

See Table 8.10 b. P

Components determined to be acceptablewhere used as a MEANS OF PROTECTION............. :

RMF Reference to specificRISKS: See appended Table8.10 & risk managementreport.

P


EN 60601-1


Reliability of components used as MEANS OFPROTECTION assessed for conditions of use inME EQUIPMENT, and they complied with one ofthe following

P

a) Applicable safety requirements of a relevantIEC or ISO standard

P

b) Requirements of this standard applied in theabsence of a relevant IEC or ISO standard

P

4.9 A COMPONENT WITH HIGH-INTEGRITYCHARACTERISTICS provided and selectedappropriately............................................................:

See appended Table 8.10 b P

RISK MANAGEMENT FILE includes an assessmentto determine if the failure of componentsresults in unacceptable RISK............................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

RMF Reference to specificRISKS:(ISO 14971 Cl. _4.4_)

P

Components identified and required to beCOMPONENTS WITH HIGH INTEGRITYCHARACTERISTIC:

See Table 8.10 b P

4.10 Power supply P

4.10.1 ME EQUIPMENT is suitable for connection toindicated power source (select applicable)........ :

Supply mainsSeparate power supplyInternally powered

P

4.10.2 Maximum rated voltage for ME EQUIPMENTintended to be connected to SUPPLY MAINS:

Not intended to be connectedto supply mains

P

- 250 V for HAND-HELD ME EQUIPMENT (V)...............: Not intended to be connectedto supply mains

N/A

– 250 V d.c. or single-phase a.c., or 500 V poly-phase a.c. for ME EQUIPMENT and ME SYSTEMS witha RATED input ≤ 4 kVA (V)....................................... :

Only 3VDC 2 x 1.5V AAAbattery

P

– 500 V for all other ME EQUIPMENT and MESYSTEMS

N/A

4.11 Power input N/A

Steady-state measured input of ME EQUIPMENT orME SYSTEM at RATED voltage or voltage range andat operating settings indicated in instructionsfor use didn’t exceed marked rating by morethan 10%.................................................................... :

See appended Table 4.11 N/A

5 GENERAL REQUIREMENTS FOR TESTING ME EQUIPMENT P

5.1 Test not performed when analysis indicatedcondition being tested was adequatelyevaluated by other tests or methods................. :

Type test P


EN 60601-1


RISK MANAGEMENT FILE identifies combinations ofsimultaneous independent faults that couldresult in a HAZARDOUS SITUATION.(ISO 14971 Cl. 4.2-4.4)

RMF Reference to specificRISKS:(ISO 14971 Cl._4.2-4.4_)

P

5.3 Tests conducted within the environmentalconditions specified in technical description

P

Temperature (ºC), Relative Humidity (%) .........: 20 ºC~32 ºC, 93%±3% —

Atmospheric Pressure (kPa)................................ : —

5.5 a) Supply voltage during tests was the leastfavourable of the voltages specified in 4.10.2 orvoltages marked on ME EQUIPMENT (V) .............. :

P

b) ME EQUIPMENTmarked with a RATED frequencyrange tested at the least favourable frequencywithin the range (Hz)...............................................:

Supplied by internal batteries N/A

c) ME EQUIPMENT with more than one RATEDvoltage, both a.c./ d.c. or both external powerand INTERNAL ELECTRICAL POWER SOURCE tested inconditions (see 5.4) related to the leastfavourable voltage, nature of supply, and typeof current................................................................... :

Only powered by internalbattery, tested with batteries

P

d) ME EQUIPMENT intended for only d.c. supplyconnection tested with d.c. and influence ofpolarity considered................................................. :

N/A

e)ME EQUIPMENT tested with alternativeACCESSORIES and components specified inACCOMPANYING DOCUMENTS to result in the leastfavourable conditions.............................................:

P

f) ME EQUIPMENT connected to a separate powersupply as specified in instructions for use

N/A

5.7 ME EQUIPMENT or parts thereof affected byclimatic conditions were set up completely, orpartially, with covers detached and subjected toa humidity preconditioning prior to tests ofClauses 8.7.4 and 8.8.3.............................................:

P

ME EQUIPMENT heated to a temperature betweenT and T + 4°C for at least 4 h and placed in ahumidity chamber and ambient within 2 °C of Tin range of +20°C to +32°C for indicated time

T = _23.0_°CTime – 48H/168H/_48_h

—

5.9 Determination of APPLIED PARTS and ACCESSIBLE PARTS P

5.9.1 APPLIED PARTS identified by inspection andreference to ACCOMPANYING DOCUMENTS.............. :

P

5.9.2 ACCESSIBLE PARTS P

5.9.2.1 Accessibility determined using standard testfinger of Fig. 6

See Appended Table 5.9.2 P


EN 60601-1


5.9.2.2 Test hook of Fig. 7 inserted in all openings ofME EQUIPMENT and pulled with a force of 20 N for10 s

N/A

5.9.2.3 Conductive parts of actuating mechanisms ofelectrical controls accessible after removal ofhandles, knobs, levers and the like regarded asACCESSIBLE PARTS................................................... :

N/A

Conductive parts of actuating mechanisms notconsidered ACCESSIBLE PARTS when removal ofhandles, knobs, required use of a TOOL..........:

N/A

6 CLASSIFICATION OF ME EQUIPMENT AND ME SYSTEMS P

6.2 CLASS I ME EQUIPMENT, externally powered N/A

CLASS II ME EQUIPMENT, externally powered N/A

INTERNALLY POWERED ME EQUIPMENT Supplied by internal batteries P

EQUIPMENT with means of connection to a SUPPLYMAINS complied with CLASS I or CLASS II MEEQUIPMENT requirements when so connected,and when not connected to SUPPLY MAINS withINTERNALLY POWERED ME EQUIPMENT requirements

N/A

TYPE B APPLIED PART N/A

TYPE BF APPLIED PART P

TYPE CF APPLIED PART N/A

DEFIBRILLATION-PROOF APPLIED PARTS N/A

6.3 ENCLOSURES classified according to degree ofprotection against ingress of water andparticulate matter as per IEC 60529.................... :

IP_X0_ N/A

6.4 ME EQUIPMENT or its parts intended to besterilized classified according to method(s) ofsterilization in instructions for use..................... :

N/A

6.5 ME EQUIPMENT and ME SYSTEMS intended for usein an OXYGEN RICH ENVIRONMENT classified forsuch use and complied with 11.2.2

N/A

6.6 CONTINUOUS or Non-CONTINUOUS OPERATION........: P

7 ME EQUIPMENT IDENTIFICATION, MARKING, AND DOCUMENTS P

7.1.2 Legibility of Markings Test for Markingsspecified in Clause 7.2-7.6...................................... :


7.1.3 Required markings can be removed only with aTOOL or by appreciable force, are durable andremain CLEARLY LEGIBLE during EXPECTEDSERVICE LIFE of ME EQUIPMENT in NORMAL USE

See appended Tables 7.1.3and 8.10

P

7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts P


EN 60601-1


7.2.1 At least markings in 7.2.2, 7.2.5, 7.2.6, 7.2.10,and 7.2.13 were applied when size ofEQUIPMENT, its part, an ACCESSORY, orENCLOSURE did not permit application of allrequired markings ................................................. :

See attached copy of MarkingPlate

P

Remaining markings fully recorded inACCOMPANYING DOCUMENTS..................................... :

N/A

Markings applied to individual packaging whenimpractical to apply to ME EQUIPMENT

N/A

Single use item marked........................................................................................:

"Single Use Only"/ “Do NotReuse”/ symbol 28 of TableD.1

N/A

7.2.2 ME EQUIPMENT marked with: P

– the name or trademark and contactinformation of the MANUFACTURER

See marking plate P

– a MODEL OR TYPE REFERENCE See attached copy of MarkingPlate

P

– a serial number or lot or batch identifier; and N/A

– the date of manufacture or use by date P

Detachable components of the ME EQUIPMENTnot marked; misidentification does not presentan unacceptable risk, or

P

RISK MANAGEMENT FILE includes an assessmentof the RISKS relating to misidentification of alldetachable parts.......................................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.4)

RMF Reference to specificRISKS:(ISO 14971 Cl._5_)

P

Detachable components of the ME EQUIPMENTare marked with the name or trademark of theMANUFACTURER, and

P

– a MODEL OR TYPE REFERENCE P

Software forming part of a PEMS identified witha unique identifier.................................................... :

P

7.2.3 Symbol 11 on Table D.1 used, optionally,advice to OPERATOR to consult ACCOMPANYINGDOCUMENTS

P

Safety sign 10 on Table D.2) used, advisingOPERATOR that ACCOMPANYING DOCUMENTS mustbe consulted

N/A

7.2.4 ACCESSORIESmarked with name or trademarkand contact information of their MANUFACTURER,and................................................................................:

Accessories inspected: __ P

- with a MODEL or TYPE REFERENCE P

– a serial number or lot or batch identifier N/A

– the date of manufacture or use by date P


EN 60601-1


Markings applied to individual packaging whennot practical to apply to ACCESSORIES

P

7.2.5 ME EQUIPMENT and ME SYSTEM intended toreceive power from other equipment, providedwith one of the following

N/A

- the name or trademark of the manufacturer ofthe other electrical equipment and typereference marked adjacent to the relevantconnection point; or

N/A

– Table D.2, safety sign No. 10 adjacent to therelevant connection point and listing of therequired details in the instructions for use; or

N/A

– Special connector style used that is notcommonly available on the market and listing ofthe required details in the instructions for use.

N/A

7.2.6 Connection to the Supply Mains N/A

Marking appearing on the outside of partcontaining SUPPLY MAINS connection and,adjacent to connection point

N/A

For PERMANENTLY INSTALLED ME EQUIPMENT,NOMINAL supply voltage or range marked insideor outside of ME EQUIPMENT

N/A

– RATED supply voltage(s) or RATED voltagerange(s) with a hyphen (-) between minimumand maximum voltages (V, V-V)............................ :

P

Multiple RATED supply voltages or multipleRATED supply voltage ranges are separated by(V/V)..............................................................................:

N/A

– Nature of supply and type of current............. : dc P

Symbols 1-5, Table D.1 (used for sameparameters................................................................. :

P

– RATED supply frequency or RATED frequencyrange in hertz............................................................. :

N/A

– Symbol 9 of Table D.1 used for CLASS II MEEQUIPMENT.................................................................... :

N/A

7.2.7 RATED input in amps or volt-amps, (A, VA)........ : N/A

RATED input in amps or volt-amps, or in wattswhen power factor exceeds 0.9 (A, VA, W)........ :

N/A

RATED input for one or more RATED voltageranges provided for upper and lower limits ofthe range or ranges when the range(s) is/aregreater than ± 10 % of the mean value ofspecified range (A, VA,W)....................................... :

N/A

Input at mean value of range marked whenrange limits do not differ by more than 10 %from mean value (A, VA, W)................................... :

N/A


EN 60601-1


Marking includes long-time and most relevantmomentary volt-ampere ratings when provided,each plainly identified and indicated inACCOMPANYING DOCUMENTS (VA).............................. :

N/A

Marked input of ME EQUIPMENT provided withmeans for connection of supply conductors ofother electrical equipment includes RATED andmarked output of such means (A, VA, W)...........:

N/A

7.2.8 Output connectors P

7.2.8.2 Output connectors are marked, except forMULTIPLE SOCKET-OUTLETS or connectorsintended for specified ACCESSORIES orequipment

N/A

Rated Voltage (V), Rated Current (A).................. : —

Rated Power (W), Output Frequency (Hz)......... : —

7.2.9 ME EQUIPMENT or its parts marked with the IPenvironmental Code per IEC 60529 according toclassification in 6.3 (Table D.3, Code 2), markingoptional for ME EQUIPMENT or parts rated IPX0....:

IPX0 equipment P

7.2.10 Degrees of protection against electric shock asclassified in 6.2 for all APPLIED PARTSmarkedwith relevant symbols ............................................:

P

TYPE B APPLIED PARTS with symbol 19 of TableD.1

Only with Type BF N/A

TYPE BF APPLIED PARTS with symbol 20 of TableD.1.................................................................................:

P

TYPE CF APPLIED PARTS with symbol 21 of TableD.1.................................................................................:

N/A

DEFIBRILLATION-PROOF APPLIED PARTSmarked withsymbols 25-27 of Table D.1.................................... :

N/A

Proper symbol marked adjacent to or onconnector for APPLIED PART..................................... :

P

Safety sign 2 of Table D.2 placed near relevantoutlet............................................................................ :

N/A

An explanation indicating protection of MEEQUIPMENT against effects of discharge of acardiac defibrillator depends on use of propercables included in instructions for use............... :

N/A

7.2.11 ME EQUIPMENT suitable for CONTINUOUS OPERATION P

DUTY CYCLE for ME EQUIPMENT intended for non-CONTINUOUS OPERATION appropriately marked toprovide maximum “on” and “off” time................ :

N/A

7.2.12 Type and full rating of a fuse marked adjacentto ACCESSIBLE fuse-holder

N/A


EN 60601-1


Fuse type.................................................................... : —

Voltage (V) and Current (A) rating....................... : —

Operating speed (s) and Breaking capacity..... : —

7.2.13 Physiological effects – safety sign and warningstatements .............................................................. :

N/A

Nature of HAZARD and precautions for avoidingor minimizing the associated RISK described ininstructions for use.................................................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.3)

RMF Reference to specificRISKS:(ISO 14971 Cl. __)

N/A

7.2.14 HIGH VOLTAGE TERMINAL DEVICES on the outside ofME EQUIPMENT accessible without the use of aTOOLmarked with symbol 24 of Table D.1

N/A

7.2.15 Requirements for cooling provisions marked... : N/A

7.2.17 Packaging marked with special handlinginstructions for transport and/or storage........... :

N/A

Permissible environmental conditions markedon outside of packaging.........................................:

N/A

Packaging marked with a suitable safety signindicating premature unpacking of MEEQUIPMENT could result in an unacceptable RISK:

N/A

RISK MANAGEMENT FILE includes the assessmentto determine premature unpacking of MEEQUIPMENT or its parts could result in anunacceptable RISK.................................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.3-6.4)


(ISO 14971 Cl.__)

N/A

Packaging of sterile ME EQUIPMENT orACCESSORIESmarked sterile and indicates themethods of sterilization

N/A

7.2.18 RATEDmaximum supply pressure from anexternal source marked on ME EQUIPMENTadjacent to each input connector, and ............. :

N/A

- the RATED flow rate also marked N/A

7.2.19 Symbol 7 of Table D.1 marked on FUNCTIONALEARTH TERMINAL...........................................................:

N/A

7.2.20 Removable protective means marked toindicate the necessity for replacement when thefunction is no longer needed.................................. :

N/A

7.2.21 MOBILE ME EQUIPMENTmarked with its massincluding its SAFE WORKING LOAD in kilograms.... :

N/A

7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts P

7.3.1 Maximum power loading of heating elements orlamp-holders designed for use with heatinglamps marked near or in the heater (W).............. :

N/A


EN 60601-1


A marking referring to ACCOMPANYING DOCUMENTSprovided for heating elements or lamp-holdersdesigned for heating lamps that can bechanged only by SERVICE PERSONNEL using aTOOL

N/A

7.3.2 Symbol 24 of Table D.1, or safety sign No.3 ofTable D.2 used to mark presence of HIGHVOLTAGE parts.............................................................:

N/A

7.3.3 Type of battery and mode of insertion marked: 2 x AAA batteries P

An identifying marking provided referring toinstructions in ACCOMPANYING DOCUMENTS forbatteries intended to be changed only bySERVICE PERSONNEL using a TOOL............................:

P

A warning provided indicating replacement oflithium batteries or fuel cells when incorrectreplacement would result in an unacceptableRISK.............................................................................. :

N/A

RISK MANAGEMENT FILE includes an assessmentto determine the replacement of lithiumbatteries or fuel cells leads to an unacceptableRISK if replaced incorrectly.................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.3)

RMF Reference to specificRISKS:(ISO 14971 Cl.__)

N/A

ACCOMPANYING DOCUMENTS contain a warningindicating the replacement of lithium batteriesor fuel cells by inadequately trained personnelcould result in a HAZARD......................................... :

N/A

7.3.4 Fuses, replaceable THERMAL CUT-OUTS and OVER-CURRENT RELEASES, accessible by use of a TOOLIdentified ................................................................... :

Specification adjacent tocomponent/reference toACCOMPANYING DOCUMENTS __

N/A

Voltage (V) and Current (A) rating....................... : —

Operating speed(s), size & breaking capacity. : —

7.3.5 PROTECTIVE EARTH TERMINAL marked with symbol6 of Table D.1

N/A

Markings on or adjacent to PROTECTIVE EARTHTERMINALS not applied to parts requiringremoval to make the connection, and remainedvisible after connection made

N/A

7.3.6 Symbol 7 of Table D.1 marked on FUNCTIONALEARTH TERMINALS

N/A

7.3.7 Terminals for supply conductors markedadjacent to terminals................................................ :

N/A

Terminals for supply connections are notmarked, the RISK MANAGEMENT FILE includes anassessment of the RISKS resulting frommisconnections......................................................... :(ISO 14971 Cl. 4.3)

RMF Reference to specificRISKS:(ISO14971 Cl. __)

N/A


EN 60601-1


Terminal markings included in ACCOMPANYINGDOCUMENTS when ME EQUIPMENT too small toaccommodate markings

N/A

Terminals exclusively for neutral supplyconductor in PERMANENTLY INSTALLED MEEQUIPMENTmarked with Code 1 of Table D.3

N/A

Marking for connection to a 3-phase supply,complies with IEC 60445

N/A

Markings on or adjacent to electricalconnection points not applied to parts requiringremoval to make connection, and remainedvisible after connection made

N/A

7.3.8 “For supply connections, use wiring materialssuitable for at least X °C” or equivalent, markedat the point of supply connections

N/A

Statement not applied to parts requiringremoval to make the connection, and CLEARLYLEGIBLE after connections made

N/A

7.4 Marking of controls and instruments P

7.4.1 The “on” & “off” positions of switch to controlpower to ME EQUIPMENT or its parts, includingmains switch, marked with symbols 12 and 13of Table D.1 or

N/A

– indicated by an adjacent indicator light, or N/A

– indicated by other unambiguous means N/A

The “on/off” positions of push button switchwith bi-stable positions marked with symbol 14of Table D.1, and

N/A

– status indicated by adjacent indicator light N/A

– status indicated by other unambiguousmeans

N/A

The “on/off” positions of push button switchwith momentary on position marked withsymbol 15 of Table D.1 or

N/A

– status indicated by adjacent indicator light N/A

– status indicated by other unambiguousmeans

N/A

7.4.2 Different positions of control devices/switchesindicated by figures, letters, or other visualmeans

P

RISK MANAGEMENT FILE identifies controls wherea change in setting during NORMAL USE resultsin an unacceptable RISK..........................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2, 6.3)


List of controls:(ISO14971 Cl.__)

N/A


EN 60601-1


Controls provided with an associatedindicating device when change of setting of acontrol could result in an unacceptable RISK toPATIENT in NORMAL USE............................................. :

P

– or an indication of direction in whichmagnitude of the function changes

N/A

Control device or switch that brings the MEEQUIPMENT into the "stand-by" conditionmarked with symbol IEC 60417-5009

N/A

7.4.3 Numeric indications of parameters on MEEQUIPMENT expressed in SI units according toISO 80000-1 except the base quantities listedin Table 1 expressed in the indicated units

P

ISO 80000-1 applied for application of SI units,their multiples, and certain other units

P

All Markings in Sub-clause 7.4 complied withtests and criteria of 7.1.2 and 7.1.3..................... :

See Appended Tables 7.1.2and 7.1.3.

P

7.5 Safety signs P

Safety sign with established meaning used P

RISK MANAGEMENT PROCESS identifies markingsused to convey a warning, prohibition ormandatory action that mitigate a RISK notobvious to the OPERATOR........................................ :(ISO 14971 Cl. 4.2-4.4, 5, 6.3)

RMF Reference to specificRISK & Marking:

Safety Sign Used:(ISO 14971 Cl._6.3_)

P

Affirmative statement together with safety signplaced in instructions for use if insufficientspace on ME EQUIPMENT

P

Specified colours in ISO 3864-1 used for safetysigns............................................................................ :

N/A

Safety notices include appropriate precautionsor instructions on how to reduce RISK(S)

P

Safety signs including any supplementary textor symbols described in instructions for use

P

- and in a language acceptable to the intendedOPERATOR

P

7.6 Symbols P

7.6.1 Meanings of symbols used for markingdescribed in instructions for use.........................:

See Appended Instruction forUse

P

7.6.3 Symbols used for controls and performanceconform to the IEC or ISO publication wheresymbols are defined, as applicable

P

7.7 Colours of the insulation of conductors P

7.7.1 PROTECTIVE EARTH CONDUCTOR identified bygreen and yellow insulation

N/A


EN 60601-1


7.7.2 Insulation on conductors inside ME EQUIPMENTforming PROTECTIVE EARTH CONNECTIONSidentified by green and yellow at least atterminations

N/A

7.7.3 Green and yellow insulation identify onlyfollowing conductors:

N/A

– PROTECTIVE EARTH CONDUCTORS N/A

– conductors specified in 7.7.2 N/A

– POTENTIAL EQUALIZATION CONDUCTORS N/A

– FUNCTIONAL EARTH CONDUCTORS N/A

7.7.4 Neutral conductors of POWER SUPPLY CORDS are“light blue”

N/A

7.7.5 Colours of conductors in POWER SUPPLY CORDSin accordance with IEC 60227-1 or IEC 60245-1

N/A

7.8 Indicator lights and controls P

7.8.1 Red indicator lights used only for Warning N/A

Yellow indicator lights used only for Caution N/A

Green indicator lights used only for Ready foruse

N/A

Other colours: Meaning other than red, yellow,or green (colour, meaning).................................... :

N/A

7.8.2 Red used only for emergency control N/A

7.9 ACCOMPANYING DOCUMENTS P

7.9.1 ME EQUIPMENT accompanied by documentscontaining instructions for use, and atechnical description

P

ACCOMPANYING DOCUMENTS identify ME EQUIPMENTby the following, as applicable:

P

– Name or trade-name of MANUFACTURER andcontact information for the RESPONSIBLEORGANIZATION can be referred to............................:

P

– MODEL or TYPE REFERENCE.....................................: P

When ACCOMPANYING DOCUMENTS providedelectronically, USABILITY ENGINEERING PROCESSincludes instructions as to what is required inhard copy or as markings on ME EQUIPMENT

P

ACCOMPANYING DOCUMENTS specify special skills,training, and knowledge required of OPERATORor RESPONSIBLE ORGANIZATION and environmentalrestrictions on locations of use

P

ACCOMPANYING DOCUMENTS written at a levelconsistent with education, training, and otherneeds of individuals for whom they areintended

P


EN 60601-1


7.9.2 Instructions for use include the required information P

7.9.2.1 – use of ME EQUIPMENT as intended by theMANUFACTURER:

P

– frequently used functions, P

– known contraindication(s) to use of MEEQUIPMENT

P

- parts of the ME EQUIPMENT that are notserviced or maintained while in use with thepatient

P

– name or trademark and address of theMANUFACTURER

P

– MODEL OR TYPE REFERENCE P

Instruction for use included the followingwhen the PATIENT is an intended OPERATOR:

P

– the PATIENT is an intended OPERATOR N/A

– warning against servicing and maintenancewhile the ME EQUIPMENT is in use

N/A

- functions the PATIENT can safely use and,where applicable, which functions the PATIENTcannot safely use; and

N/A

–maintenance the PATIENT can perform N/A

Classifications as in Clause 6, all markings perClause 7.2, and explanation of safety signsand symbols marked on ME EQUIPMENT

N/A

Instructions for use are in a languageacceptable to the intended operator

P

7.9.2.2 Instructions for use include all warning andsafety notices

See User manual P

Warning statement for CLASS I ME EQUIPMENTincluded

N/A

Warnings regarding significant RISKS ofreciprocal interference posed by ME EQUIPMENTduring specific investigations or treatments

P

Information on potential electromagnetic orother interference and advice on how to avoidor minimize such interference

P

Warning statement for ME EQUIPMENT suppliedwith an integral MULTIPLE SOCKET-OUTLETprovided

N/A

The RESPONSIBLE ORGANIZATION is referred tothis standard for the requirements applicableto ME SYSTEMS

N/A

7.9.2.3 Statement on ME EQUIPMENT for connection to aseparate power supply provided ininstructions

N/A


EN 60601-1


7.9.2.4 Warning statement for mains- operated MEEQUIPMENT with additional power source notautomatically maintained in a fully usablecondition indicating the necessity for periodicchecking or replacement of power source

N/A

RISK MANAGEMENT FILE assesses the RISKresulting from leakage of batteries.....................:(ISO 14971 Cl. 4.2-4.4, 5, 6.3)

Specific RISKS:

(ISO 14971 Cl.__)

N/A

Where the RISK is unacceptable, the IFUincludes a warning to remove the battery if theME EQUIPMENT is not likely to be used for sometime..............................................................................:

N/A

Specifications of replaceable INTERNALELECTRICAL POWER SOURCE when provided........ :

P

Warning indicating ME EQUIPMENT must beconnected to an appropriate power sourcewhen loss of power source would result in anunacceptable RISK................................................... :

P

7.9.2.5 Instructions for use include a description of MEEQUIPMENT, its functions, significant physicaland performance characteristics together withthe expected positions of OPERATOR, PATIENT, orother persons near ME EQUIPMENT in NORMALUSE

P

Information provided on materials andingredients PATIENT or OPERATOR is exposed to

N/A

Restrictions specified on other equipment orNETWORK/DATA COUPLINGS, other than thoseforming part of an ME SYSTEM, to which a SIGNALINPUT/OUTPUT PART may be connected

N/A

APPLIED PARTS specified P

7.9.2.6 Information provided indicating where theinstallation instructions may be found orinformation on qualified personnel who canperform the installation

P

7.9.2.7 Instructions provided indicating not to positionME EQUIPMENT to make it difficult to operate thedisconnection device

N/A

7.9.2.8 Necessary information provided for OPERATORto bring ME EQUIPMENT into operation

P

7.9.2.9 Information provided to operate ME EQUIPMENT P

Meanings of figures, symbols, warningstatements, abbreviations and indicator lightsdescribed in instructions for use

P


EN 60601-1


7.9.2.10 A list of all system messages, error messages,and fault messages provided with anexplanation of messages including importantcauses and possible action(s) to be taken toresolve the problem indicated by the message

P

7.9.2.11 Information provided for the OPERATOR tosafely terminate operation of ME EQUIPMENT

P

7.9.2.12 Information provided on cleaning, disinfection,and sterilization methods, and applicableparameters that can be tolerated by MEEQUIPMENT parts or ACCESSORIES specified

P

Components, ACCESSORIES or ME EQUIPMENTmarked for single use, except when requiredby MANUFACTURER to be cleaned, disinfected, orsterilized prior to use

P

7.9.2.13 Instructions provided on preventiveinspection, calibration, maintenance and itsfrequency

P

Information provided for safe performance ofroutine maintenance necessary to ensurecontinued safe use of ME EQUIPMENT

P

Parts requiring preventive inspection andmaintenance to be performed by SERVICEPERSONNEL identified including periods ofapplication

P

Instructions provided to ensure adequatemaintenance of ME EQUIPMENT containingrechargeable batteries to be maintained byanyone other than SERVICE PERSONNEL

N/A

7.9.2.14 A list of ACCESSORIES, detachable parts, andmaterials for use with ME EQUIPMENT provided

P

Other equipment providing power to ME SYSTEMsufficiently described

N/A

7.9.2.15 Disposal of waste products, residues, etc., andof ME EQUIPMENT and ACCESSORIES at the end oftheir EXPECTED SERVICE LIFE are identified in theinstruction for use................................................... :

P

7.9.2.16 Instructions for use include informationspecified in 7.9.3 or identify where it can befound (e.g. in a service manual)

P

7.9.2.17 Instruction for use for ME EQUIPMENT emittingradiation for medical purposes, indicate thenature, type, intensity and distribution of thisradiation

N/A

7.9.2.18 The instructions for use for ME EQUIPMENT orACCESSORIES supplied sterile indicate that theyhave been sterilized and the method ofsterilization

N/A


EN 60601-1


The instructions for use indicate the necessaryinstructions in the event of damage to thesterile packaging, and where appropriate,details of the appropriate methods of re-sterilization

N/A

7.9.2.19 The instructions for use contain a uniqueversion identifier...................................................... :

Version __ N/A

7.9.3 Technical description P

7.9.3.1 All essential data provided for safe operation,transport, storage, and measures orconditions necessary for installing MEEQUIPMENT, and preparing it for use including

P

-information required in 7.2 P

-permissible environmental conditions of useincluding conditions for transport andstorage…………………………………………….. :

P

-characteristics of the ME EQUIPMENT,including range(s), accuracy, and precision ofthe displayed values or an indication wherethey can be found

P

-special installation requirements such as themaximum permissible apparent impedance ofSUPPLY MAINS

N/A

-permissible range of values of inlet pressureand flow, and the chemical composition ofcooling liquid

N/A

-description of the means for checking the oillevel in partially sealed oil filled MEEQUIPMENT or its parts

N/A

-warning statement that addresses theHAZARDS that can result from unauthorizedmodification of the ME EQUIPMENT

N/A

-information pertaining to ESSENTIALPERFORMANCE and any necessary recurrentESSENTIAL PERFORMANCE and BASICSAFETY testing including details of the means,methods and recommended frequency

P

Technical description separable from instructions for use contains requiredinformation, as follows

P

-information required by 7.2 P

–applicable classifications in Clause 6,warning and safety notices, and explanation ofsafety signs marked on ME EQUIPMENT

P

– brief description of the ME EQUIPMENT, howthe ME EQUIPMENT functions and its significantphysical and performance characteristics; and

P

a unique version identifier......................................: Version __ N/A


EN 60601-1


MANUFACTURER’S optional requirements forminimum qualifications of SERVICE PERSONNELdocumented in technical description

N/A

7.9.3.2 The technical description contains the following required information P

–type and full rating of fuses used in SUPPLYMAINS external to PERMANENTLY INSTALLED MEEQUIPMENT...................................................................:

N/A

– a statement for ME EQUIPMENT with a non-DETACHABLE POWER SUPPLY CORD if POWERSUPPLY CORD is replaceable by SERVICEPERSONNEL, and

N/A

– instructions for correct replacement ofinterchangeable or detachable parts specifiedby MANUFACTURER as replaceable by SERVICEPERSONNEL, and

N/A

RISK MANAGEMENT FILE includes an assessmentto determine if replacement of componentsresults in any unacceptable RISKS.......................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

– warnings identifying nature of HAZARD whenreplacement of a component could result in anunacceptable RISK, and when replaceable bySERVICE PERSONNEL all information necessary tosafely replace the component

N/A

7.9.3.3 Technical description indicates, MANUFACTURERwill provide circuit diagrams, component partlists, descriptions, calibration instructions toassist to SERVICE PERSONNEL in parts repair

P

7.9.3.4 Means used to comply with requirements of8.11.1 clearly identified in technical description

N/A

8 PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT P

8.1 Limits specified in Clause 8.4 not exceeded forACCESSIBLE PARTS and APPLIED PARTS in NORMALor SINGLE FAULT CONDITIONS

P

RISK MANAGEMENT FILE identifies conductors andconnectors where breaking free results in aHAZARDOUS SITUATION............................................... :(ISO 14971 Cl. 4.3)


P

8.2 Requirements related to power sources P

8.2.1 Connection to a separate power source P

When ME EQUIPMENT specified for connection toa separate power source other than SUPPLYMAINS, separate power source considered aspart of ME EQUIPMENT or combinationconsidered as an ME SYSTEM

N/A


EN 60601-1


Tests performed with ME EQUIPMENT connectedto separate power supply when one specified

N/A

When a generic separate power supplyspecified, specification in ACCOMPANYINGDOCUMENTS examined

N/A

8.2.2 Connection to an external d.c. power source N/A

No HAZARDOUS SITUATION as described in 13.1developed when a connection with wrongpolarity made for ME EQUIPMENT from anexternal d.c. source

N/A

ME EQUIPMENT connected with correct polaritymaintained BASIC SAFETY and ESSENTIALPERFORMANCE

N/A

Protective devices that can be reset by anyonewithout a TOOL returns to NORMAL CONDITION onreset

N/A

8.3 Classification of APPLIED PARTS P

a) APPLIED PART specified in ACCOMPANYINGDOCUMENTS as suitable for DIRECT CARDIACAPPLICATION is TYPE CF

N/A

b) An APPLIED PART provided with a PATIENTCONNECTION intended to deliver electricalenergy or an electrophysiological signal to orfrom PATIENT is TYPE BF or CF APPLIED PART

Type BF P

c) An APPLIED PART not covered by a) or b) is aTYPE B, BF, or CF

N/A

8.4 Limitation of voltage, current or energy P

8.4.2 ACCESSIBLE PARTS and APPLIED PARTS P

a) Currents from, to, or between PATIENTCONNECTIONS did not exceed limits for PATIENTLEAKAGE CURRENT & PATIENT AUXILIARY CURRENT:

See appended Table 8.7 P

b) LEAKAGE CURRENTS from, to, or betweenACCESSIBLE PARTS did not exceed limits forTOUCH CURRENT..........................................................:


c) Limits specified in b) not applied to partswhen probability of a connection to a PATIENT,directly or through body of OPERATOR, isnegligible in NORMAL USE, and the OPERATOR isappropriately instructed

N/A

Voltage to earth or to other ACCESSIBLE PARTSdid not exceed 42.4 V peak a.c. or 60 V d.c. forabove parts in NORMAL or single fault condition(V a.c. or d.c.)............................................................:

See appended Table 8.4.2 N/A

Energy did not exceed 240 VA for longer than60 s or stored energy available did not exceed20 J at a potential of 2 V or more (VA or J).......:



EN 60601-1


d) Voltage and energy limits specified in c)above also applied to the following:

N/A

– internal parts touchable by test pin in Fig 8inserted through an opening in an ENCLOSURE;and

N/A

– internal parts touchable by a metal test rodwith a diameter of 4 mm and a length 100 mm,inserted through any opening on top ofENCLOSURE or through any opening provided foradjustment of pre-set controls by RESPONSIBLEORGANIZATION in NORMAL USE using a TOOL

N/A

Test pin or the test rod inserted throughrelevant openings with minimal force of nomore than 1 N

N/A

Test rod inserted in every possible positionthrough openings provided for adjustment ofpre-set controls that can be adjusted in NORMALUSE, with a force of 10 N

N/A

Test repeated with a TOOL specified ininstructions for use

N/A

Test rod freely and vertically suspendedthrough openings on top of ENCLOSURE

N/A

e) Devices used to de-energize parts when anACCESS COVER opened without a TOOL givesaccess to parts at voltages above levelspermitted by this Clause comply with 8.11.1 formains isolating switches and remain effectivein SINGLE FAULT CONDITION

N/A

A TOOL is required when it is possible toprevent the devices from operating

N/A

8.4.3 Worst case voltage between pins of plug andbetween either supply pin and ENCLOSURE didnot exceed 60 V one sec after disconnectingthe plug of ME EQUIPMENT or its parts (V)........... :


When voltage exceeded 60 V, calculated ormeasured stored charge didn’t exceed 45μC.... :


8.4.4 Residual voltage of conductive parts ofcapacitive circuits, having become accessibleafter ME EQUIPMENT was de-energized afterremoval of ACCESS COVERS, didn’t exceed 60V orcalculated stored charge didn’t exceed 45μC... :


A device manually discharging capacitors usedwhen automatic discharging was not possibleand ACCESS COVERS could be removed only withaid of a TOOL

N/A


EN 60601-1


Capacitor(s) and connected circuitry markedwith symbol 24 of Table D.1, and manualdischarging device specified in technicaldescription................................................................ :

N/A

8.5 Separation of parts P

8.5.1 MEANS OF PROTECTION (MOP) P

8.5.1.1 Two MEANS of PROTECTION provided for MEEQUIPMENT to prevent APPLIED and otherACCESSIBLE PARTS from exceeding limits in 8.4

P

Varnishing, enamelling, oxidation, and similarprotective finishes and coatings with sealingcompounds re-plasticizing at temperaturesexpected during operation and sterilizationdisregarded as MEANS OF PROTECTION

P

Components and wiring forming a MEANS OFPROTECTION comply with 8.10

P

8.5.1.2 MEANS OF PATIENT PROTECTION (MOPP) P

Solid insulation forming a MEANS OF PATIENTPROTECTION complied with dielectric strengthtest...............................................................................:

See appended Table 8.8.3 P

CREEPAGE and CLEARANCES forming a MEANS OFPATIENT PROTECTION complied with Table 12

P

PROTECTIVE EARTH CONNECTIONS forming a MEANSOF PATIENT PROTECTION complied with Cl. 8.6

P

Y1 or Y2 capacitor complying with standardIEC 60384-14 considered one MEANS OF PATIENTPROTECTION ............................................................... :


N/A

Single Y1 capacitor used for two MEANS OFPATIENT PROTECTION when the working voltage isless than 42,4 V peak a.c. or 60 V d.c................ :


N/A

Two capacitors used in series, each RATED fortotal WORKING VOLTAGE across the pair and havethe same NOMINAL capacitance

N/A

Voltage Total Working (V) and C Nominal (F)...............: —

8.5.1.3 MEANS OF OPERATOR PROTECTION (MOOP) P

Solid insulation forming a MEANS OF OPERATORPROTECTION complied with:

P

– dielectric strength test ......................................: See appended Table 8.8.3 P

– requirements of IEC 60950-1 for INSULATIONCO-ORDINATION

N/A

CREEPAGE and CLEARANCES forming a MEANS OFOPERATOR PROTECTION complied with:

P

– limits of Tables 13 to 16 (inclusive); or P


EN 60601-1


– requirements of IEC 60950-1 for INSULATIONCO-ORDINATION

N/A

PROTECTIVE EARTH CONNECTIONS forming a MEANSOF OPERATOR PROTECTION complied with Cl. 8.6

N/A

– or with requirements and tests of IEC 60950-1for protective earthing............................................ :

See Attachment No. __ N/A

A Y2 (IEC 60384-14) capacitor is consideredone MEANS OF OPERATOR PROTECTION.................... :


N/A

A Y1 (IEC 60384-14 ) capacitor is consideredtwo MEANS OF OPERATOR PROTECTION.................... :


N/A

Two capacitors used in series each RATED fortotal WORKING VOLTAGE across the pair and havethe same NOMINAL capacitance

N/A

Voltage Total Working (V) and C Nominal (F)...............: —

Points and applied parts at which impedancesof components, CREEPAGE, CLEARANCES,PROTECTIVE EARTH CONNECTIONS or insulation,prevent ACCESSIBLE PARTS from exceeding limitsin 8.4 were examined whether a failure at any ofthese points is to be regarded as a NORMAL orSINGLE FAULT CONDITION

P

A MEANS OF PROTECTION protecting APPLIEDPARTS, or parts identified by 4.6 as partssubject to the same requirements, consideredMEANS OF PATIENT PROTECTION................................ :

P

A MEANS OF PROTECTION protecting other partsconsidered MEANS OF OPERATOR PROTECTION..... :

P

8.5.2 Separation of PATIENT CONNECTIONS P

8.5.2.1 PATIENT CONNECTIONS of F-TYPE APPLIED PARTseparated from all other parts by equivalent toone MEANS OF PATIENT PROTECTION for a WORKINGVOLTAGE equal to the MAX. MAINS VOLTAGE..........:

For additional RM information,see appended Tables 8.7 and8.8.3See also Table 11.6.1

P

Separation requirement not applied betweenmultiple functions of a single F-TYPE APPLIEDPART

P

PATIENT CONNECTIONS treated as one APPLIEDPART in the absence of electrical separationbetween PATIENT CONNECTIONS of same oranother function

P

MANUFACTURER has defined if multiple functionsare to be considered as all within one APPLIEDPART or as multiple APPLIED PARTS ........................:

N/A

Classification as TYPE BF, CF, or DEFIBRILLATION-PROOF applied to one entire APPLIED PART

Type BF P

LEAKAGE CURRENT tests conducted per 8.7.4.....: See appended Table 8.7 P

Dielectric strength test conducted per 8.8.3.....: See appended Table 8.8.3 P


EN 60601-1


CREEPAGE and CLEARANCES measured ...............: Refer to Insulation Diagram P

A protective device connected between PATIENTCONNECTIONS of an F-TYPE APPLIED PART andENCLOSURE to protect against excessivevoltages did not operate below 500 V r.m.s

N/A

8.5.2.2 PATIENT CONNECTIONS of a TYPE B APPLIED PARTnot PROTECTIVELY EARTHED are separated by oneMEANS OF PATIENT PROTECTION from metalACCESSIBLE PARTS not PROTECTIVELY EARTHED.....:

N/A

– except when metal ACCESSIBLE PART isphysically close to APPLIED PART and can beregarded as a part of APPLIED PART; and

N/A

– RISK that metal ACCESSIBLE PART will makecontact with a source of voltage or LEAKAGECURRENT above permitted limits is acceptablylow

N/A

LEAKAGE CURRENT tests conducted per 8.7.4.....: See appended Table 8.7 N/A

Dielectric strength test conducted per 8.8.3.....: See appended Table 8.8.3 N/A

Relevant CREEPAGE and CLEARANCES measured Refer to Insulation Diagram N/A

RISK MANAGEMENT FILE includes an assessmentof the RISK of metal ACCESSIBLE PARTS contactinga source of voltage or LEAKAGE CURRENT abovethe limits......................................................................:(ISO 14971 Cl. 4.2-4.4, 5)


N/A

8.5.2.3 A connector on a PATIENT lead or PATIENT cable located at the end of the leador cable remote from PATIENT, with conductive part not separated from allPATIENT CONNECTIONS by one MEANS OF PATIENT PROTECTION for a WORKINGVOLTAGE equal to MAXIMUM MAINS VOLTAGE

P

- cannot be connected to earth or hazardousvoltage while the PATIENT CONNECTIONS are incontact with PATIENT.................................................:

P

– conductive part of connector not separatedfrom all PATIENT CONNECTIONS did not come intocontact with a flat conductive plate of not lessthan 100 mm diameter

P

– CLEARANCE between connector pins and a flatsurface is at least 0.5 mm

P

– conductive part pluggable into a mainssocket protected from contacting parts at MAINSVOLTAGE by insulation with a CREEPAGE DISTANCEof at least 1.0 mm, a 1500 V dielectric strengthand complying with 8.8.4.1

N/A

– required test finger did not make electricalcontact with conductive part when appliedagainst access openings with a force of 10 N,

N/A

Test finger test (10 N)............................................... : See appended Table 5.9.2 N/A


EN 60601-1


Except when RISK MANAGEMENT PROCESSincludes an assessment of RISKS resulting fromcontact with objects other than mains socketsor flat surfaces........................................................... :(ISO 14971 Cl. 4.2-4.4, 5)

RMF Reference to specificRISKS:(ISO 14971 Cl.__)See appended Table 5.9.2

N/A

8.5.4 WORKING VOLTAGE P

– Input supply voltage to ME EQUIPMENT wasRATED voltage or voltage within RATED rangeresulting in highest measured value (V)........... :

N/A

– WORKING VOLTAGE for d.c. voltages withsuperimposed ripple was average value whenpeak-to-peak ripple less than 10% of averagevalue or peak voltage when peak-to-peak rippleexceeding 10% of average value (V).................. :

3V dc P

– WORKING VOLTAGE for each MEANS OFPROTECTION forming DOUBLE INSULATION wasvoltage DOUBLE INSULATION, as a whole,subjected to (V)........................................................ :

See Insulation Diagram andInsulation Table

P

– Intentional or accidental earthing of PATIENTregarded as a NORMAL CONDITION for WORKINGVOLTAGE involving a PATIENT CONNECTION notconnected to earth

P

– WORKING VOLTAGE between PATIENTCONNECTIONS of an F-TYPE APPLIED PART andENCLOSURE was highest voltage appearingacross insulation in NORMAL USE includingearthing of any part of APPLIED PART (V)............ :

0 P

– WORKING VOLTAGE for DEFIBRILLATION-PROOFAPPLIED PARTS determined disregardingpossible presence of defibrillation voltages

N/A

– WORKING VOLTAGE was equal to resonancevoltage in case of motors provided withcapacitors between the point where a windingand a capacitor are connected together and aterminal for external conductors (V).................. :

N/A

8.5.5 DEFIBRILLATION-PROOF APPLIED PARTS N/A

8.5.5.1 Classification “DEFIBRILLATION-PROOF APPLIEDPART” applied to one APPLIED PART in its entirety

N/A

Isolation of PATIENT CONNECTIONS of aDEFIBRILLATION-PROOF APPLIED PART from otherparts of ME EQUIPMENT accomplished as follows:

N/A

a) No hazardous electrical energies appearduring a discharge of cardiac defibrillator ...... :

See appended Table 8.5.5.1a N/A

b) ME EQUIPMENT complied with relevantrequirements of this standard, providing BASICSAFETY and ESSENTIAL PERFORMANCE followingexposure to defibrillation voltage, and recoverytime stated in ACCOMPANYING DOCUMENTS............:

See appended Table 8.5.5.1b N/A


EN 60601-1


8.5.5.2 Means provided to limit energy delivered to a100 Ω load.................................................................. :

See appended Table 8.5.5.2 N/A

8.6 Protective and functional earthing and potential equalization of ME EQUIPMENT N/A

8.6.1 Requirements of 8.6.2 to 8.6.8 applied N/A

Parts complying with IEC 60950-1 for protectiveearthing and serving as MEANS OF OPERATORPROTECTION but not PATIENT PROTECTIONexempted from requirements of 8.6.2 to 8.6.8

N/A

8.6.2 PROTECTIVE EARTH TERMINAL is suitable forconnection to an external protective earthingsystem by a PROTECTIVE EARTH CONDUCTOR in aPOWER SUPPLY CORD and a suitable plug or by aFIXED PROTECTIVE EARTH CONDUCTOR..................... :

N/A

Clamping means of PROTECTIVE EARTH TERMINALof ME EQUIPMENT for FIXED supply conductors orPOWER SUPPLY CORDS comply with 8.11.4.3, andcannot be loosened without TOOL

N/A

Screws for internal PROTECTIVE EARTHCONNECTIONS completely covered or protectedagainst accidental loosening from outside...... :

N/A

Earth pin of APPLIANCE INLET forming supplyconnection to ME EQUIPMENT regarded asPROTECTIVE EARTH TERMINAL

N/A

PROTECTIVE EARTH TERMINAL not used formechanical connection between different partsof ME EQUIPMENT or securing components notrelated to protective or functional earthing

N/A

8.6.3 PROTECTIVE EARTH CONNECTION not used for amoving part,

N/A

except when MANUFACTURER demonstrated inRISK MANAGEMENT FILE connection will remainreliable during EXPECTED SERVICE LIFE ................ :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

RMF Reference to proof ofreliability:(ISO 14971 Cl.__)

N/A

8.6.4 a) PROTECTIVE EARTH CONNECTIONS carried faultcurrents reliably and without excessive voltagedrop...............................................................................:


b) Allowable TOUCH CURRENT and PATIENTLEAKAGE CURRENT in SINGLE FAULT CONDITIONwere not exceeded, when impedance ofPROTECTIVE EARTH CONNECTIONS exceeded valuesin 8.6.4 a) and Table 8.6.4, due to limitedcurrent capability of relevant circuits.................:

See appended Table 8.6.4 &Clause 8.7

N/A

8.6.5 Surface coatings N/A

Poorly conducting surface coatings onconductive elements removed at the point ofcontact

N/A


EN 60601-1


Coating not removed when requirements forimpedance and current-carrying capacity met

N/A

8.6.6 Plugs and sockets N/A

PROTECTIVE EARTH CONNECTION whereconnection between SUPPLY MAINS and MEEQUIPMENT or between separate parts of MEEQUIPMENT made via a plug and socket wasmade before and interrupted after supplyconnections

N/A

- applied also where interchangeable parts arePROTECTIVELY EARTHED

N/A

8.6.7 Terminal for connection of a POTENTIAL EQUALIZATION CONDUCTOR N/A

– Terminal is accessible to OPERATOR with MEEQUIPMENT in any position of NORMAL USE

N/A

–accidental disconnection avoided in NORMALUSE

N/A

– Terminal allows conductor to be detachedwithout a TOOL

N/A

– Terminal not used for a PROTECTIVE EARTHCONNECTION

N/A

– Terminal marked with symbol 8 of Table D.1 N/A

– Instructions for use contain information onfunction and use of POTENTIAL EQUALIZATIONCONDUCTOR together with a reference torequirements of this standard

N/A

POWER SUPPLY CORD does not incorporate aPOTENTIAL EQUALIZATION CONDUCTOR

N/A

8.6.8 FUNCTIONAL EARTH TERMINAL not used to providea PROTECTIVE EARTH CONNECTION

N/A

8.6.9 Class II ME EQUIPMENT N/A

Third conductor of POWER SUPPLY CORDconnected to protective earth contact of MAINSPLUG provided with CLASS II ME EQUIPMENT withisolated internal screens used as functionalearth connection to the screen’s FUNCTIONALEARTH TERMINAL, coloured green and yellow

N/A

ACCOMPANYING DOCUMENTS include a statementthat the third conductor in the POWER SUPPLYCORD is only a functional earth.

N/A

Two MEANS OF PROTECTION provided betweeninsulation of internal screens and all internalwiring connected to them and ACCESSIBLE PARTS

N/A

8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS P


EN 60601-1


8.7.1 a) Electrical isolation providing protectionagainst electric shock limits currents to valuesin 8.7.3......................................................................... :

See appended Tables 8.7 P

b) Specified values of EARTH LEAKAGE, TOUCH,PATIENT LEAKAGE, and PATIENT AUXILIARYCURRENTS applied in combination of conditionsin appended Table 8.7............................................. :

See appended Tables 8.7 P

8.7.2 Allowable values specified in 8.7.3 appliedunder SINGLE FAULT CONDITIONS of 8.1 b), except

P

– where insulation used in conjunction with aPROTECTIVE EARTH CONNECTION, insulation shortcircuited only under conditions in 8.6.4 b)

N/A

– the only SINGLE FAULT CONDITION for EARTHLEAKAGE CURRENT was interruption of onesupply conductor at a time

N/A

– LEAKAGE CURRENTS and PATIENT AUXILIARYCURRENT not measured in SINGLE FAULTCONDITION of short circuiting of one constituentpart of DOUBLE INSULATION

P

SINGLE FAULT CONDITIONS not applied at sametime as special test conditions of MAXIMUMMAINS VOLTAGE on APPLIED PARTS and non-PROTECTIVELY EARTHED parts of ENCLOSURE

P

8.7.3 Allowable Values P

a) Allowable values in 8.7.3 b), c), and d)measured based on, and are relative tocurrents in Fig 12 a), or by a device measuringfrequency contents of currents as in Fig 12 b. :


b) Allowable values of PATIENT LEAKAGE andAUXILIARY CURRENTS are according to Tables 3 &4, and values of a.c. are relative to currentshaving a frequency not less than 0.1Hz............. :


c) TOUCH CURRENT did not exceed 100μA inNORMAL CONDITION and 500μA in SINGLE FAULTCONDITION (ITNC, ITSFC).................................................:


d) EARTH LEAKAGE CURRENT did not exceed 5 mAin NORMAL CONDITION and 10 mA in SINGLE FAULTCONDITION (IENC, IESFC)................................................ :


Higher values of EARTH LEAKAGE CURRENTpermitted for PERMANENTLY INSTALLED MEEQUIPMENT connected to a supply circuitsupplying only this ME EQUIPMENT according tolocal regulations or IEC 60364-7-710.................. :


e) LEAKAGE CURRENTS, regardless of waveformand frequency, did not exceed 10 mA r.m.s. inNORMAL or in SINGLE FAULT CONDITION (measuredwith a non-frequency-weighted device.............. :



EN 60601-1


f) LEAKAGE CURRENTS flowing in a FUNCTIONALEARTH CONDUCTOR in a non-PERMANENTLYINSTALLED ME EQUIPMENT are 5 mA in NORMALCONDITION, 10 mA in SINGLE FAULT CONDITION...... :


8.7.4 LEAKAGE and PATIENT AUXILIARY CURRENTSmeasurements...........................................................:


8.8 Insulation P

8.8.1 Insulation relied on as MEANS OF PROTECTION,including REINFORCED INSULATION subjected totesting

P

Insulation exempted from test (complies withclause 4.8)

N/A

Insulation forming MEANS OF OPERATORPROTECTION and complying with IEC 60950-1 forINSULATION CO-ORDINATION not tested as in 8.8

N/A

8.8.2 Distance through solid insulation or use of thin sheet material N/A

Solid insulation forming SUPPLEMENTARY orREINFORCED INSULATION for a PEAK WORKINGVOLTAGE greater than 71 V provided with:

N/A

a) 0.4 mm, min, distance through insulation, or N/A

b) does not form part of an ENCLOSURE and notsubject to handling or abrasion during NORMALUSE, and comprised of:

N/A

– at least two layers of material, each passedthe appropriate dielectric strength test.............. :


– or three layers of material, for which allcombinations of two layers together passedthe appropriate dielectric strength test.............. :


Dielectric strength test for one or two layerswas same as for one MEANS OF PROTECTION forSUPPLEMENTARY INSULATION

N/A

Dielectric strength test for one or two layerswas same as for two MEANS OF PROTECTION forREINFORCED INSULATION

N/A

BASIC, SUPPLEMENTARY, and REINFORCEDINSULATION required between windings ofwound components separated by interleavedinsulation complying with a) or b), or both,except when

N/A

c) Wire with solid insulation, other than solventbased enamel, complying with a)

N/A

d) Wire with multi-layer extruded or spirallywrapped insulation complying with b) andcomplying with Annex L

N/A


EN 60601-1


e) Finished wire with spirally wrapped or multi-layer extruded insulation, complying withAnnex L

N/A

– BASIC INSULATION: minimum two wrappedlayers or one extruded layer

N/A

– SUPPLEMENTARY INSULATION: minimum twolayers, wrapped or extruded

N/A

– REINFORCED INSULATION: minimum three layers,wrapped or extruded

N/A

In d) and e), for spirally wrapped insulationwith CREEPAGE DISTANCES between layers lessthan in Table 12 or 16 (Pollution Degree 1)depending on type of insulation, path betweenlayers sealed as a cemented joint in 8.9.3.3 andtest voltages of TYPE TESTS in L.3 equal 1.6times of normal values

N/A

Protection against mechanical stress providedwhere two insulated wires or one bare and oneinsulated wire are in contact inside woundcomponent, crossing at an angle between 45°and 90° and subject to winding tension............:

N/A

Finished component complied with routinedielectric strength tests of 8.8.3......................... :


Tests of Annex L not repeated since materialdata sheets confirm compliance.........................:

See Table 8.10 and MaterialInformation Attachment

N/A

8.8.3 Dielectric Strength P

Solid insulating materials with a safety functionwithstood dielectric strength test voltages .....:


8.8.4 Insulation other than wire insulation P

8.8.4.1 Resistance to heat retained by all insulationand insulating partition walls during EXPECTEDSERVICE LIFE of ME EQUIPMENT

P

ME EQUIPMENT and design documentationexamined.................................................................... :

See attachment No. __ P

RISK MANAGEMENT FILE examined in conjunctionwith resistance to moisture, dielectric strength,and mechanical strength tests............................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

Satisfactory evidence of compliance providedby manufacturer for resistance to heat.............. :

See Attachment No._8.10_ N/A

Tests conducted in absence of satisfactoryevidence for resistance to heat............................ :

N/A

a) ENCLOSURE and other external parts ofinsulating material, except insulation of flexiblecords and parts of ceramic material, subjectedto ball-pressure test using Fig 21 apparatus.... :



EN 60601-1


b) Parts of insulating material supportinguninsulated parts of MAINS PART subjected toball-pressure test in a), except at 125 °C ± 2 ° Cor ambient indicated in technical description±2°C plus temperature rise determined duringtest of 11.1 of relevant part, if higher (°C)..........:


Test not performed on parts of ceramicmaterial, insulating parts of commutators,brush-caps, and similar, and on coil formersnot used as REINFORCED INSULATION

N/A

8.8.4.2 Resistance to environmental stress P

Insulating characteristics and mechanicalstrength of all MEANS OF PROTECTION not likely tobe impaired by environmental stressesincluding deposition of dirt resulting from wearof parts within EQUIPMENT, potentially reducingCREEPAGE and CLEARANCES below 8.9

P

Ceramic and similar materials not tightlysintered, and beads alone not used asSUPPLEMENTARY or REINFORCED INSULATION

P

Insulating material with embedded heatingconductors considered as one MEANS OFPROTECTION but not two MEANS OF PROTECTION

P

Parts of natural latex rubber aged bysuspending samples freely in an oxygencylinder containing commercial oxygen to apressure of 2.1 MPa ± 70 kPa, with an effectivecapacity of at least 10 times volume of samples

N/A

There were no cracks visible to naked eyesafter samples kept in cylinder at 70 °C ± 2 °Cfor 96h, and afterwards, left at roomtemperature for at least 16h

N/A

8.9 CREEPAGE DISTANCES and AIR CLEARANCES P

8.9.1.1 CREEPAGE DISTANCES and AIR CLEARANCES areequal to or greater than values in Tables 12 to16 (inclusive).............................................................:

Refer to Insulation Diagram P

8.9.1.15 CREEPAGE DISTANCES and AIR CLEARANCES forDEFIBRILLATION-PROOF APPLIED PARTS are 4 mm ormore to meet 8.5.5.1

N/A

8.9.2 a) Short circuiting of each single one ofCREEPAGE DISTANCES and CLEARANCES in turn didnot result in a HAZARDOUS SITUATION , minCREEPAGE and CLEARANCES not applied...............:


8.9.3 Spaces filled by insulating compound N/A

8.9.3.1 Only solid insulation requirements appliedwhere distances between conductive partsfilled with insulating compound

N/A


EN 60601-1


Thermal cycling, humidity preconditioning, anddielectric strength tests

N/A

8.9.3.2 For insulating compound forming solidinsulation between conductive parts, a singlesample subjected to thermal cycling PROCEDUREof 8.9.3.4 followed by humidity preconditioningper 5.7 (for 48 hours), followed by dielectricstrength test (cl. 8.8.3 at 1,6 x test voltage)...... :


Cracks or voids in insulating compoundaffecting homogeneity of material didn’t occur

N/A

8.9.3.3 Where insulating compound forms a cementedjoint with other insulating parts, three samplestested for reliability of joint

N/A

A winding of solvent-based enamelled wirereplaced for the test by a metal foil or by a fewturns of bare wire placed close to cementedjoint, and three samples tested as follows:

N/A

– One sample subjected to thermal cyclingPROCEDURE of 8.9.3.4, and immediately after thelast period at highest temperature duringthermal cycling followed by dielectric strengthtest of cl. 8.8.3 at 1.6 x the test voltage ............ :


– The other two samples subjected to humiditypreconditioning of 5.7, except for 48 hours onlyfollowed by a dielectric strength test of cl. 8.8.3at 1.6 times the test voltage

N/A

8.9.4 Minimum spacing of grooves transvers to theCREEPAGE DISTANCES considered a MEANS OFOPERATOR PROTECTION adjusted based onpollution degree ……………………………………

Pollution degree: P

Force was applied between bare conductorsand outside metal enclosure when measuringCREEPAGE DISTANCES and AIR CLEARANCES

Refer to Insulation Diagramsupplemental information forlocation and force used

P

8.10 Components and wiring P

8.10.1 Components of ME EQUIPMENT likely to result inan unacceptable RISK by their movementsmounted securely.....................................................:

N/A

RISK MANAGEMENT FILE includes an assessmentof RISKS related to unwanted movement ofcomponents.............................................................. :(ISO 14791 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

8.10.2 Conductors and connectors of ME EQUIPMENTadequately secured or insulated to preventaccidental detachment............................................:

P

Stranded conductors are not solder-coatedwhen secured by clamping means to preventHAZARDOUS SITUATIONS

P


EN 60601-1


8.10.3 Interconnecting flexible cords detachablewithout a TOOL used provided with means forconnection to comply with requirements formetal ACCESSIBLE PARTS when a connection isloosened or broken .................................................:


8.10.4 Cord-connected HAND-HELD parts and cord-connected foot-operated controldevices

N/A

8.10.4.1 Control devices of ME EQUIPMENT and theirconnection cords contain only conductors andcomponents operating at 42.4 V peak a.c., max,or 60 V d.c. in circuits isolated from MAINS PARTby two MEANS OF PROTECTION

N/A

8.10.4.2 Connection and anchorage of a flexible cord toa HAND-HELD or foot-operated control device ofME EQUIPMENT, at both ends of the cable to thecontrol device, complies with the requirementsfor POWER SUPPLY CORDS in Cl. 8.11.3

N/A

Other HAND-HELD parts, if disturbance orbreaking of one or more of the connectionscould result in a HAZARDOUS SITUATION, alsocomply with tests of Cl. 8.11.3

N/A

8.10.5 Mechanical protection of wiring N/A

a) Internal cables and wiring adequatelyprotected against contact with a moving part orfrom friction at sharp corners and edges.......... :

N/A

b) Wiring, cord forms, or components are notlikely to be damaged during assembly orduring opening or closing of ACCESS COVERS

N/A

8.10.6 Guiding rollers prevent bending of movableinsulated conductors around a radius of lessthan five times the outer diameter of the lead

N/A

8.10.7 a) Insulating sleeve adequately secured...........: See appended Table 8.10 N/A

b) Sheath of a flexible cord not used as a MEANSOF PROTECTION inside ME EQUIPMENT when it issubject to mechanical or thermal stressesbeyond its RATED characteristics

P

c) Insulated conductors of ME EQUIPMENTsubject to temperatures exceeding 70 °C..........:


8.11 MAINS PARTS, components and layout P

8.11.1 a) ME EQUIPMENT provided with means ofelectrically isolating its circuits from SUPPLYMAINS simultaneously on all poles....................... :


PERMANENTLY INSTALLED ME EQUIPMENTconnected to a poly-phase SUPPLY MAINSequipped with a device not interrupting neutralconductor, provided local installationconditions prevent voltage on neutralconductor from exceeding limits in 8.4.2 c)

N/A


EN 60601-1


PERMANENTLY INSTALLED ME EQUIPMENT providedwith means to isolate its circuits electricallyfrom the SUPPLY MAINS are capable of beinglocked in the off position

N/A

- the isolation device specified in theACCOMPANYING DOCUMENTS

N/A

b) Means of isolation incorporated in MEEQUIPMENT, or if external, described intechnical description .............................................:


c) A SUPPLY MAINS switch used to comply with8.11.1 a) complies with CREEPAGE / CLEARANCESfor a MAINS TRANSIENT VOLTAGE of 4 kV.................:


d) A SUPPLY MAINS switch not incorporated in aPOWER SUPPLY CORD or external flexible lead

N/A

e) Actuator of a SUPPLY MAINS switch used tocomply with 8.11.1 a) complies with IEC 60447

N/A

f) A suitable plug device used in non-PERMANENTLY INSTALLED ME EQUIPMENT with noSUPPLY MAINS SWITCH.................................................:


g) A fuse or a semiconductor device not usedas an isolating means

P

h) ME EQUIPMENT not provided with a devicecausing disconnection of ME EQUIPMENT fromSUPPLY MAINS by producing a short circuitresulting in operation of an overcurrentprotection device

N/A

i) Parts within ENCLOSURE of ME EQUIPMENT witha circuit > 42.4 V peak a.c. or 60 V d.c. thatcannot be disconnected from its supply by anexternal switch or a plug device accessible atall times is protected against touch even afteropening ENCLOSURE by an additional covering

N/A

A clear warning notice is marked on outside ofME EQUIPMENT to indicate it exceeds allowabletouch voltage

N/A

For a part that could not be disconnected fromsupply by an external switch or a plug deviceaccessible at all times, the required cover orwarning notice complied with this clause

N/A

Standard test finger applied N/A

8.11.2 MULTIPLE SOCKET-OUTLETS integral with MEEQUIPMENT complied with 16.2 d), second dash;and 16.9.2

8.11.3 POWER SUPPLY CORDS N/A

8.11.3.1 MAINS PLUG not fitted with more than one POWERSUPPLY CORD

N/A


EN 60601-1


8.11.3.2 POWER SUPPLY CORDS are no less robust thanordinary tough rubber sheathed flexible cord(IEC 60245-1:2003, Annex A, designation 53) orordinary polyvinyl chloride sheathed flexiblecord (IEC 60227-1:1993, Annex A, design 53)....:


Only polyvinyl chloride insulated POWER SUPPLYCORD with appropriate temperature rating usedfor ME EQUIPMENT having external metal partswith a temperature > 75 °C touchable by thecord in NORMAL USE .................................................. :


8.11.3.3 NOMINAL cross-sectional area of conductors ofPOWER SUPPLY CORDS of ME EQUIPMENT is not lessthan in Table 17........................................................:

N/A

8.11.3.4 APPLIANCE COUPLERS complying with IEC 60320-1 are considered to comply with 8.11.3.5 and8.11.3.6..........................................................................:


8.11.3.5 Cord anchorage N/A

a) Conductors of POWER SUPPLY CORD providedwith strain relief and insulation protected fromabrasion at point of entry to ME EQUIPMENT or aMAINS CONNECTOR by a cord anchorage

N/A

b) Cord anchorage of POWER SUPPLY CORD is aninsulating material, or

N/A

– metal, insulated from conductive ACCESSIBLEPARTS non-PROTECTIVELY EARTHED by a MEANS OFPROTECTION, or

N/A

– metal provided with an insulating liningaffixed to cord anchorage

N/A

c) Cord anchorage prevents cord from beingclamped by a screw bearing directly on cordinsulation

N/A

d) Screws to be operated when replacingPOWER SUPPLY CORD do not serve to secure anycomponents

N/A

e) Conductors of POWER SUPPLY CORD arrangedto prevent PROTECTIVE EARTH CONDUCTOR againststrain as long as phase conductors are incontact with their terminals

N/A

f) Cord anchorage prevents POWER SUPPLY CORDfrom being pushed into ME EQUIPMENT or MAINSCONNECTOR

N/A

Conductors of POWER SUPPLY CORD supplied byMANUFACTURER disconnected from terminals orfrom MAINS CONNECTOR and cord subjected 25times to a pull applied with no jerks, each timefor 1 s, on sheath of the value in Table 18.........:


Cord subjected to a torque in Table 18 for oneminute immediately after pull tests

N/A


EN 60601-1


Cord anchorage did not allow cord sheath tobe longitudinally displaced by more than 2 mmor conductor ends to move over a distance ofmore than 1 mm from their connected position

N/A

CREEPAGE and CLEARANCES not reduced belowlimits in 8.9

N/A

It was not possible to push the cord into MEEQUIPMENT or MAINS CONNECTOR to an extent thecord or internal parts would be damaged

N/A

8.11.3.6 POWER SUPPLY CORDS protected againstexcessive bending at inlet opening ofequipment

N/A

Cord guard complied with test of IEC 60335-1:2001, Clause 25.14, or

N/A

ME EQUIPMENT placed such that axis of cordguard projected at an angle of 45° with cordfree from stress, and a mass equal 10 x D2

gram attached to the free end of cord (g)........:


Cord guard of temperature-sensitive materialtested at 23 °C ± 2 °C, and flat cords bent in theplane of least resistance

N/A

Curvature of the cord radius, immediately aftermass attached, was not less than 1.5 x D....... :


8.11.4 MAINS TERMINAL DEVICES N/A

8.11.4.1 PERMANENTLY INSTALLED and ME EQUIPMENT withnon-DETACHABLE POWER SUPPLY CORD providedwith MAINS TERMINAL DEVICES ensuring reliableconnection

N/A

Terminals alone are not used to keepconductors in position

N/A

Terminals of components other than terminalblocks complying with requirements of thisClause and marked accordingly used asterminals intended for external conductors

N/A

Screws and nuts clamping external conductorsdo not serve to secure any other component

N/A

8.11.4.2 Arrangement of MAINS TERMINAL DEVICES N/A

a) Terminals provided for connection ofexternal cords or POWER SUPPLY CORDS togetherwith PROTECTIVE EARTH TERMINAL grouped toprovide convenient means of connection

N/A

d) MAINS TERMINAL DEVICES not accessiblewithout use of a TOOL

N/A


EN 60601-1


e) MEANS OF PROTECTION are not short circuitedwhen one end of a flexible conductor withNOMINAL cross-sectional area is stripped 8 mmand a single free wire is bent in each possibledirection

N/A

8.11.4.3 Internal wiring not subjected to stress andCREEPAGE and CLEARANCES not reduced afterfastening and loosening a conductor of largestcross-sectional area 10 times

N/A

8.11.4.4 Terminals with clamping means for arewireable flexible cord did not require specialpreparation of conductors and conductorswere not damaged and did not slip out whenclamping means tightened

N/A

8.11.4.5 Adequate space provided inside ME EQUIPMENTdesigned for FIXED wiring or a rewireable POWERSUPPLY CORD to allow for connection ofconductors

N/A

Correct connection and positioning ofconductors before ACCESS COVER verified by aninstallation test

N/A

8.11.5 Mains fuses and OVER-CURRENT RELEASES N/A

A fuse or OVER-CURRENT RELEASE provided ineach supply lead for CLASS I and CLASS II MEEQUIPMENT with a functional earth connection..:


- in at least one supply lead for other single-phase CLASS II ME EQUIPMENT.................................. :

N/A

– neutral conductor not fused for PERMANENTLYINSTALLED ME EQUIPMENT

N/A

– fuses or OVER-CURRENT RELEASES omitted dueto provision of two MEANS OF PROTECTIONbetween all parts within MAINS PART

N/A

Protective devices have adequate breakingcapacity to interrupt the max. fault current.......:


A fuse or OVER-CURRENT RELEASE not providedin a PROTECTIVE EARTH CONDUCTOR

N/A

Justification for omission of fuses or OVER-CURRENT RELEASES documented........................... :

See Attachment No.__ N/A

8.11.6 Internal wiring of the MAINS PART N/A

a) Cross-sectional area of internal wiring in aMAINS PART between MAINS TERMINAL DEVICE orAPPLIANCE INLET and protective devices suitable...................................................................................... :

N/A

b) Cross-sectional area of other wiring in MAINSPART and sizes of tracks on printed wiringcircuits are sufficient...............................................:

See appended Table 8.10 fordetails

N/A


EN 60601-1


9 PROTECTION AGAINST MECHANICAL HAZARDS OF ME EQUIPMENT ANDME SYSTEMS

P

9.2 HAZARDS associated with moving parts P

9.2.1 When ME EQUIPMENT with moving partsPROPERLY INSTALLED, used per ACCOMPANYINGDOCUMENTS or under foreseeable misuse, RISKSassociated with moving parts reduced to anacceptable level........................................................ :

P

RISK from contact with moving parts reduced toan acceptable level using protective measures,(access, function, shape of parts, energy,speed of motion, and benefits to PATIENTconsidered)

P

RESIDUAL RISK associated with moving partsconsidered acceptable when exposure wasneeded for ME EQUIPMENT to perform itsintended function, and

N/A

RISK CONTROLS implemented..................................: N/A

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with moving parts.............. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

All RISKS associated with moving parts havebeen reduced to an acceptable level

N/A

9.2.2 TRAPPING ZONE N/A

9.2.2.1 ME EQUIPMENT with a TRAPPING ZONE compliedwith one or more of the following as feasible:

N/A

– Gaps in Clause 9.2.2.2, or N/A

– Safe distances in Clause 9.2.2.3, or N/A

– GUARDS and other RISK CONTROL measures in9.2.2.4, or

N/A

– Continuous activation in Clause 9.2.2.5 N/A

Control of relevant motion complied with9.2.2.6 when implementation of aboveprotective measures were inconsistent withINTENDED USE of ME EQUIPMENT or ME SYSTEM

N/A

9.2.2.2 A TRAPPING ZONE considered not to present aMECHANICAL HAZARD when gaps of TRAPPINGZONE complied with dimensions per Table 20.. :


9.2.2.3 A TRAPPING ZONE considered not to present aMECHANICAL HAZARD when distances separatingOPERATOR, PATIENT, and others from TRAPPINGZONES exceeded values in ISO 13857:2008 ..... :


9.2.2.4 GUARDS and other RISK CONTROL measures N/A


EN 60601-1


9.2.2.4.1 A TRAPPING ZONE do not to present aMECHANICAL HAZARD when GUARDS or other RISKCONTROL measures are of robust construction,not easy to bypass or render non-operational,and did not introduce additional unacceptableRISK............................................................................... :


9.2.2.4.2 FIXED GUARDS held in place by systems thatcan only be dismantled with a TOOL

N/A

9.2.2.4.3 Movable GUARDS that can be opened without aTOOL remained attached when GUARD was open

N/A

– they are associated with an interlockpreventing relevant moving parts from startingto move while TRAPPING ZONE is accessible,and stops movement when the GUARD isopened,

N/A

– absence or failure of one of theircomponents prevents starting, and stopsmoving parts

N/A

Movable GUARDS complied with any applicabletests

N/A

9.2.2.4.4 Other RISK CONTROL designed and incorporatedinto to the control system stops movementand

N/A

– SINGLE FAULT CONDITIONS have a second RISKCONTROL, or

N/A

ME EQUIPMENT is SINGLE FAULT SAFE N/A

9.2.2.5 Continuous activation N/A

Continuous activation used as a RISK CONTROL,complies with the following

N/A

a) movement was in OPERATOR'S field of view N/A

b) movement of ME EQUIPMENT or its parts waspossible only by continuous activation ofcontrol by OPERATOR

N/A

c) a second RISK CONTROL provided for SINGLEFAULT CONDITION of continuous activationsystem, or

N/A

- the continuous activation system is SINGLEFAULT SAFE

N/A

9.2.2.6 Speed of movement(s) positioning parts of MEEQUIPMENT or PATIENT limited to allow OPERATORcontrol of the movement

N/A

Over travel of such movement occurring afteroperation of a control to stop movement, didnot result in an unacceptable RISK

N/A

9.2.3 Other MECHANICAL HAZARDS associated with moving parts N/A


EN 60601-1


9.2.3.1 Controls positioned, recessed, or protected byother means so that they cannot beaccidentally actuated

N/A

- unless for the intended PATIENT, the USABILITYENGINEERING PROCESS concludes otherwise(e.g. PATIENT with special needs), or

N/A

- activation does not result in an unacceptableRISK

N/A

9.2.3.2 Over travel past range limits of the MEEQUIPMENT prevented................................................:

N/A

Over travel means provided with mechanicalstrength to withstand loading in NORMALCONDITION & reasonably foreseeable misuse.... :


9.2.4 Emergency stopping devices N/A

Where necessary to have one or moreemergency stopping device(s), emergencystopping device complied with all thefollowing, except for actuating switch capableof interrupting all power......................................... :

N/A

a) Emergency stopping device reduced RISK toan acceptable level

N/A

RISK MANAGEMENT FILE indicates the use of anemergency stopping device reduces the RISKto an acceptable level.............................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.6)


N/A

b) Proximity and response of OPERATOR toactuate emergency stopping device could berelied upon to prevent HARM

N/A

c) Emergency stopping device actuator wasreadily accessible to OPERATOR

N/A

d) Emergency stopping device(s) are not partof normal operation of ME EQUIPMENT

N/A

e) Emergency switching operation or stoppingmeans neither introduced further HAZARD norinterfered with operation necessary to removeoriginal MECHANICAL HAZARD

N/A

f) Emergency stopping device was able tobreak full load of relevant circuit, includingpossible stalled motor currents and the like

N/A

g) Means for stopping of movements operateas a result of one single action

N/A

h) Emergency stopping device provided withan actuator in red and easily distinguishableand identifiable from other controls

N/A

i) An actuator interrupting/opening mechanicalmovements marked on or immediatelyadjacent to face of actuator with symbol 18 ofTable D.1 or “STOP”

N/A


EN 60601-1


j) Emergency stopping device, once actuated,maintained ME EQUIPMENT in disabled conditionuntil a deliberate action, different from thatused to actuate it, was performed

N/A

k) Emergency stopping device is suitable forits application

N/A

9.2.5 Means provided to permit quick and saferelease of PATIENT in event of breakdown of MEEQUIPMENT or failure of power supply,activation of a RISK CONTROL measure, oremergency stopping............................................... :

P

– and uncontrolled or unintended movementof ME EQUIPMENT that could result in anunacceptable RISK prevented

P

– Situations where PATIENT is subjected tounacceptable RISKS due to proximity of movingparts, removal of normal exit routes, or otherHAZARDS prevented

N/A

– Measures provided to reduce RISK to anacceptable level when after removal ofcounterbalanced parts, other parts of MEEQUIPMENT can move in a hazardous way

N/A

RISK MANAGEMENT FILE includes an assessmentof RISKS to the PATIENT related to breakdown ofthe ME EQUIPMENT......................................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


(ISO 14971 Cl.__)

N/A

9.3 Rough surfaces, sharp corners and edges ofME EQUIPMENT that could result in injury ordamage avoided or covered.................................. :

P

9.4 Instability HAZARDS P

9.4.1 ME EQUIPMENT and its parts, other than FIXED,for placement on a surface did notoverbalance (tip over) or move unexpectedlyin NORMAL USE

N/A

9.4.2 Instability – overbalance N/A

9.4.2.1 ME EQUIPMENT or its parts did not overbalancewhen prepared per ACCOMPANYING DOCUMENTS,or when tested...........................................................:


9.4.2.2 Instability excluding transport N/A

ME EQUIPMENT or its did not overbalance whenplaced in different positions of NORMAL USE,....:


A warning provided when overbalanceoccurred during 10° inclined plane test

N/A

9.4.2.3 Instability from horizontal and vertical forces N/A


EN 60601-1


a) ME EQUIPMENT or its parts with a mass of25kg or more, intended to be used on thefloor, didn’t overbalance due to pushing,leaning against it

N/A

Surfaces of ME EQUIPMENT or its parts where aRISK of overbalancing exists from pushing,etc., permanently marked with a warning of theRISK

N/A

ME EQUIPMENT did not overbalance when testedaccording to Cl. 9.4.2.3 a)


b) ME EQUIPMENT, for use on the floor or on atable, did not overbalance due to sitting orstepping

N/A

ME EQUIPMENT or its parts, for use on the flooror on a table, where RISK of overbalancingexists, permanently marked with the RISKwarning.......................................................................:

N/A

ME EQUIPMENT did not overbalance when testedaccording to Cl. 9.4.2.3b)....................................... :


9.4.2.4 Castors and wheels N/A

9.4.2.4.1 Means used for transportation of MOBILE MEEQUIPMENT did not result in an unacceptableRISK when MOBILE ME EQUIPMENT moved orparked in NORMAL USE

N/A

9.4.2.4.2 Force required to move MOBILE ME EQUIPMENTdid not exceed 200 N............................................... :

See appended Table 9.4.2.4.2 N/A

9.4.2.4.3 MOBILE ME EQUIPMENT exceeding 45 kg able topass over threshold ...............................................:

See appended Table 9.4.2.4.3 N/A

9.4.3 Instability from unwanted lateral movement (including sliding) N/A

9.4.3.1 a) Brakes of power-driven MOBILE ME EQUIPMENTnormally activated and could only be releasedby continuous actuation of a control

N/A

b) MOBILE ME EQUIPMENT provided with lockingmeans to prevent unwanted movements

N/A

c) No unwanted lateral movement resultedwhen MOBILE ME EQUIPMENT placed in itstransport position when test per 9.4.3.1


9.4.3.2 Instability excluding transport N/A

a) MOBILE ME EQUIPMENT provided with wheellocks or braking system compliant with 5 tilttest .............................................................................:


b) MOBILE ME EQUIPMENT provided with wheellocks or braking system compliant with lateralstability test


9.4.4 Grips and other handling devices N/A


EN 60601-1


a) ME EQUIPMENT with a mass of over 20 kgrequiring lifting in NORMAL USE or transportprovided with suitable handling means, orACCOMPANYING DOCUMENTS specify safe liftingmethod

N/A

Handles, suitably placed to enable MEEQUIPMENT or its part to be carried by two ormore persons and by examination ofEQUIPMENT, its part, or ACCOMPANYINGDOCUMENTS

N/A

b) PORTABLE ME EQUIPMENT with a mass > 20 kgprovided with one or more carrying-handlessuitably placed to enable carrying by two ormore persons as confirmed by actual carrying

N/A

c) Carrying handles and grips and their meansof attachment withstood loading test................ :


9.5 Expelled parts HAZARD N/A

9.5.1 Suitability of means of protecting againstexpelled parts determined by assessment andexamination of RISK MANAGEMENT FILE................ :(ISO 14971 Cl. 4.3, 4.4, 5, 6.2-6.5)


N/A

All identified RISKS associated with expelledparts mitigated to an acceptable level

N/A

9.5.2 Cathode Ray tube(s) complied with IEC60065:2001, Clause 18, or IEC 61965................. :


9.6 Acoustic energy (including infra- and ultrasound) and vibration N/A

9.6.1 Human exposure to acoustic energy andvibration from ME EQUIPMENT doesn’t result inunacceptable RISK and

N/A

If necessary, confirmed in RISK MANAGEMENTFILE including audibility of auditory alarmsignals, and PATIENT sensitivity........................... :

N/A

If necessary, confirmed in RISK MANAGEMENTFILE including audibility of auditory alarmsignals, PATIENT sensitivity, and(ISO 14971 Cl. 4.2-44, 5, 6.2-6.5)


N/A

All identified RISKS mitigated to an acceptablelevel

N/A

9.6.2 Acoustic energy N/A

9.6.2.1 PATIENT, OPERATOR, and other persons are notexposed to acoustic energy from ME EQUIPMENTin NORMAL USE

N/A

– 80 dBA for a cumulative exposure of 24 hover a 24 h period (dBA)........................................:

—

- 83 dBA (when halving the cumulativeexposure time) (dBA)............................................. :

—


EN 60601-1


– 140 dBC (peak) sound pressure level forimpulsive or impact acoustic energy (dB)........:

—

9.6.2.2 RISK MANAGEMENT FILE examined..........................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

9.6.3 Hand-transmitted vibration N/A

Means provided to protect PATIENT andOPERATOR when hand-transmitted frequency-weighted r.m.s. acceleration generated inNORMAL USE exceeds specified values

N/A

– 2.5 m/s2 for a cumulative time of 8 h during a24 h period (m/s2).................................................... :

N/A

– Accelerations for different times, inverselyproportional to square root of time (m/s2)........ :

N/A

9.7 Pressure vessels and parts subject to pneumatic and hydraulic pressure P

9.7.2 Pneumatic and hydraulic parts of MEEQUIPMENT or ACCESSORIES met requirementsbased on examination of RISK MANAGEMENT FILE......................................................................................:(ISO 14971 Cl. 4.3-4.4, 5, 6.2-6.5)

RMF Reference to specificRISKS:(ISO 14971 Cl._6.2_)

P

– No unacceptable RISK resulted from loss ofpressure or loss of vacuum

P

– No unacceptable RISK resulted from a fluidjet caused by leakage or a component failure

N/A

– Elements of ME EQUIPMENT or an ACCESSORY,especially pipes and hoses leading to anunacceptable RISK protected against harmfulexternal effects

P

– Reservoirs and similar vessels leading to anunacceptable RISK are automaticallydepressurized when ME EQUIPMENT is isolatedfrom its power supply

N/A

Means provided for isolation, or localdepressurizing reservoirs and similar vessels,and pressure indication when above notpossible

N/A

– All elements remaining under pressure afterisolation of ME EQUIPMENT or an ACCESSORYfrom its power supply resulting in anunacceptable RISK provided with clearlyidentified exhaust devices, and a warning todepressurize these elements before setting ormaintenance activity

N/A

9.7.3 Maximum pressure a part of ME EQUIPMENT canbe subjected to in NORMAL and SINGLE FAULTCONDITIONS considered to be highest offollowing:

N/A


EN 60601-1


a) RATED maximum supply pressure from anexternal source

N/A

b) Pressure setting of a pressure-relief deviceprovided as part of assembly

N/A

c) Max pressure that can develop by a sourceof pressure that is part of assembly, unlesspressure limited by a pressure-relief device

N/A

9.7.4 Max pressure in NORMAL and SINGLE FAULTCONDITIONS did not exceed MAXIMUM PERMISSIBLEWORKING PRESSURE for EQUIPMENT part, exceptas allowed in 9.7.7, confirmed by inspection ofTHE MANUFACTURER'S data for the component,ME EQUIPMENT, and by functional tests............... :

P

9.7.5 A pressure vessel withstood a HYDRAULIC TESTPRESSURE when pressure was more than 50kPa, and product of pressure and volume wasmore than 200 kPa.................................................. :


9.7.6 Pressure-control device regulating pressure inME EQUIPMENT with pressure-relief devicecompleted 100,000 cycles of operation underRATED load and prevented pressure fromexceeding 90 % of setting of pressure-reliefdevice in different conditions of NORMAL USE .:

N/A

9.7.7 Pressure-relief device(s) used where MAXIMUMPERMISSIBLE WORKING PRESSURE could otherwisebe exceeded met the following, as confirmedby MANUFACTURER’S data, ME EQUIPMENT, RISKMANAGEMENT FILE, and functional tests.............. :

N/A

a) Connected as close as possible to pressurevessel or parts of system it is to protect

N/A

b) Installed to be readily accessible forinspection, maintenance, and repair

N/A

c) Could be adjusted or rendered inoperativewithout a TOOL

N/A

d) With discharge opening located anddirected as to not to release material towardsany person

N/A

e) With discharge opening located anddirected as to not to deposit material on partsthat could result in an unacceptable RISK

N/A

f) Adequate discharge capacity provided toensure that pressure will not exceed MAXIMUMPERMISSIBLE WORKING PRESSURE of system it isconnected to by more than 10 % when failureoccurs in control of supply pressure

N/A

g) No shut-off valve provided between apressure-relief device and parts it is to protect

N/A


EN 60601-1


h) Min number of cycles of operation 100 000,except for one-time use devices (burstingdisks)

N/A

RISK MANAGEMENT FILE includes an assessmentof the risks associated with the dischargeopening of the pressure relief device................ :(ISO 14971 Cl. 4.3, 4.4, 5, 6.2-6.5)


N/A

9.8 HAZARDS associated with support systems N/A

9.8.1 ME EQUIPMENT parts designed to support loadsor provide actuating forces when a mechanicalfault could constitute an unacceptable RISK .. :


– Construction of support, suspension, oractuation system complied with Table 21 andTOTAL LOAD

N/A

– Means of attachment of ACCESSORIES preventpossibility of incorrect attachment that couldresult in an unacceptable RISK

N/A

– RISK ANALYSIS of support systems includedMECHANICAL HAZARDS from static, dynamic,vibration, foundation and other movements,impact and pressure loading, temperature,environmental, manufacture and serviceconditions..................................................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

– RISK ANALYSIS included effects of failuressuch as excessive deflection, plasticdeformation, ductile/brittle fracture, fatiguefracture, instability (buckling), stress-assistedcorrosion cracking, wear, material creep anddeterioration, and residual stresses frommanufacturing PROCESSES

N/A

– Instructions on attachment of structures to afloor, wall, ceiling, included in ACCOMPANYINGDOCUMENTS making adequate allowances forquality of materials used to make theconnection and list the required materials

N/A

Additional instructions provided on checkingadequacy of surface of structure parts will beattached to

N/A

9.8.2 Support systems maintain structural integrityduring EXPECTED SERVICE LIFE, and TENSILESAFETY FACTORS are not less than in Table 21,except when an alternative method used todemonstrate structural integrity throughoutEXPECTED SERVICE LIFE, or for a foot rest

N/A

Compliance with 9.8.1 and 9.8.2 confirmed byexamination of ME EQUIPMENT, RISK MANAGEMENTFILE, specifications and material processing... :

N/A


EN 60601-1


RISK MANAGEMENT FILE includes an assessmentof the structural integrity of support system...:(ISO 14971 Cl. 4.3-4.4, 5, 6.2-6.5)


N/A

All identified RISKS are mitigated to anacceptable level

N/A

When test was conducted, testing consisted ofapplication of a test load to support assemblyequal to TOTAL LOAD times required TENSILESAFETY FACTOR while support assembly undertest was in equilibrium after 1 min, or notresulted in an unacceptable RISK........................ :


Where the equipment is not at equilibriumafter 1 min, the RISK MANAGEMENT FILE includesan assessment of the test results.......................:(ISO 14971 Cl. 4.3-4.4, 5, 6.2-6.5)

RMF Reference to specificRISK:(ISO 14971 Cl.__)

N/A

9.8.3 Strength of PATIENT or OPERATOR support or suspension systems N/A

9.8.3.1 ME EQUIPMENT parts supporting or immobilizingPATIENTS presents no unacceptable RISK ofphysical injuries and accidental loosening ofsecured joints...........................................................:

N/A

RISK MANAGEMENT FILE includes assessment ofthe RISKS associated with physical injuries andaccidental loosening of fixings........................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

SAFE WORKING LOAD of ME EQUIPMENT or its partssupporting or suspending PATIENTS orOPERATORS is sum of mass of PATIENTS or massof OPERATORS plus mass of ACCESSORIESsupported by ME EQUIPMENT or its parts

N/A

Supporting and suspending parts for adulthuman PATIENTS or OPERATORS designed for aPATIENT or OPERATOR with a min mass of 135 kgand ACCESSORIES with a min mass of 15 kg,unless stated by MANUFACTURER

N/A

Maximum mass of PATIENT included in SAFEWORKING LOAD of ME EQUIPMENT or its partssupporting or suspending PATIENTS adaptedwhen MANUFACTURER specified applications

N/A

Max allowable PATIENT mass < 135 kg markedon ME EQUIPMENT and stated in ACCOMPANYINGDOCUMENTS

N/A

Max allowable PATIENT mass over 135 kg statedin ACCOMPANYING DOCUMENTS

N/A

Examination of markings, ACCOMPANYINGDOCUMENTS, and RISK MANAGEMENT FILEconfirmed compliance ......................................... :

See copy of Marking Label N/A


EN 60601-1


9.8.3.2 a) Entire mass of PATIENT or OPERATORdistributed over an area of 0.1 m2 on a footrest temporarily supporting a standing PATIENTor OPERATOR.............................................................. :

N/A

Compliance confirmed by examination of MEEQUIPMENT specifications of materials and theirprocessing, and tests.............................................:

See appended Tables 8.10and 9.8.3.2

N/A

b) Deflection of a support surface from PATIENTor OPERATOR loading on an area of support/suspension where a PATIENT or OPERATOR cansit did not result in an unacceptable RISK

N/A

Compliance confirmed by examination of MEEQUIPMENT, specifications of materials andtheir processing, and by a test............................:

See appended Tables 8.10and 9.8.3.2

N/A

9.8.3.3 Dynamic forces that can be exerted onequipment parts supporting or suspending aPATIENT or OPERATOR in NORMAL USE maintainedBASIC SAFETY and ESSENTIAL PERFORMANCEconfirmed test


9.8.4 Systems with MECHANICAL PROTECTIVE DEVICES N/A

9.8.4.1 a) A MECHANICAL PROTECTIVE DEVICE providedfor the support system

N/A

b) MECHANICAL PROTECTIVE complies with therequirements as follows:

N/A

– Designed based on TOTAL LOAD N/A

– Has TENSILE SAFETY FACTORS for all parts notless than Table 21, row 7

N/A

– Activated before travel produced anunacceptable RISK

N/A

– Considers Clauses 9.2.5 and 9.8.4.3 N/A

Compliance confirmed by examination of MEEQUIPMENT over travel calculations andevaluation plus functional tests ........................:


9.8.4.2 Activation of MECHANICAL PROTECTIVE DEVICE ismade obvious to OPERATOR when ME EQUIPMENTcan still be used after failure of suspension oractuation means and activation of aMECHANICAL PROTECTIVE DEVICE

N/A

MECHANICAL PROTECTIVE DEVICE requires use ofa TOOL to be reset or replaced

N/A

9.8.4.3 MECHANICAL PROTECTIVE DEVICE intended to function once N/A

–use of ME EQUIPMENT not possible untilreplacement of MECHANICAL PROTECTIVE DEVICE......................................................................................:

N/A


EN 60601-1


– ACCOMPANYING DOCUMENTS provided withrequired information on replacement byservice personal

N/A

– ME EQUIPMENT permanently marked withsafety sign 2 of Table D.

N/A

– Marking is adjacent to MECHANICALPROTECTIVE DEVICE

N/A

– Compliance confirmed by examination andfollowing test............................................................:


A chain, cable, band, spring, belt, jack screwnut, pneumatic or hydraulic hose, structuralpart or the like, employed to support a load,defeated by a convenient means causingmaximum normal load to fall from mostadverse position permitted by construction ofME EQUIPMENT

N/A

Load included SAFE WORKING LOAD in 9.8.3.1when system was capable of supporting aPATIENT or OPERATOR

N/A

No evidence of damage to MECHANICALPROTECTIVE DEVICE affecting its ability toperform its intended function

N/A

9.8.5 Systems without MECHANICAL PROTECTIVE DEVICES N/A

Support Systems does not require MECHANICALPROTECTIVE DEVICES.................................................. :

N/A

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with wear on the supportsystem........................................................................ :(ISO 14971 Cl. 4.3,4.4,5,6.2-6.5)


N/A

10 PROTECTION AGAINST UNWANTED AND EXCESSIVE RADIATION HAZARDS N/A

10.1 X-Radiation N/A

10.1.1 The air kerma did not exceed 5 µGy/hat 5 cmfrom surface of ME EQUIPMENT...............................:

See Table 10.1.1 N/A

Annual exposure reduced taking into accountthe irradiated body part, national regulations,and/or international recommendations for MEEQUIPMENT that has permanent proximity to aPATIENT as part of the INTENDED USE

N/A

10.1.2 RISK from unintended X-radiation from MEEQUIPMENT producing X-radiation for diagnosticand therapeutic purposes addressedapplication of applicable particular andcollateral standards, or..........................................:

N/A


EN 60601-1


RISK MANAGEMENT PROCESS as indicated in RISKMANAGEMENT FILE...................................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

10.2 RISK associated with alpha, beta, gamma,neutron, and other particle radiation,addressed in RISK MANAGEMENT PROCESS asshown in RISK MANAGEMENT FILE........................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

10.3 The power density of unintended microwaveradiation at frequencies between 1 GHz and100 GHz does not exceed 10 W/m2

N/A

Microwave radiation is propagated intentionally N/A

10.4 Relevant requirements of IEC 60825-1:2007applied to lasers, laser light barriers or similarwith a wavelength range of 180nm to 1 mm.

N/A

10.5 RISK associated with visible electromagneticradiation other than emitted by lasers and LEDS,when applicable, addressed in RISKMANAGEMENT PROCESS as indicated in RISKMANAGEMENT FILE...................................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

10.6 RISK associated with infrared radiation otherthan emitted by lasers and LEDS addressed inRISK MANAGEMENT PROCESS as indicated in RISKMANAGEMENT FILE...................................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

10.7 RISK associated with ultraviolet radiation otherthan emitted by lasers and LEDS addressed inRISK MANAGEMENT PROCESS as indicated in RISKMANAGEMENT FILE...................................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

11 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHERHAZARDS

P

11.1 Excessive temperatures in ME EQUIPMENT P

11.1.1 Temperatures on ME EQUIPMENT parts did notexceed values in Tables 22 and.......................... :


Surfaces of test corner did not exceed 90 °C P

THERMAL CUT-OUTS did not operate in NORMALCONDITION

N/A

RISK MANAGEMENT FILE includes an assessmentof the duration of contact for all APPLIED PARTSand ACCESSIBLE PARTS............................................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

RMF Reference to specificRISK:(ISO 14971 Cl.__)

N/A

11.1.2 Temperature of APPLIED PARTS P

11.1.2.1 APPLIED PARTS (hot or cold intended to supplyheat to a PATIENT comply....................................... :

N/A


EN 60601-1


Clinical effects determined and documented inthe RISK MANAGEMENT FILE

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

Temperature (hot or cold) of APPLIED PARTSintended to supply heat to a PATIENT disclosedin the instructions for use

N/A

11.1.2.2 APPLIED PARTS not intended to supply heat to aPATIENT complies with the limits of Table 24 inNORMAL CONDITION and SINGLE FAULT CONDITION.:

P

APPLIED PARTS surface temperature exceeds41°C disclosed in the instruction manual:

P

Maximum Temperature..........................................: —

Conditions for safe contact, e.g. duration orcondition of the PATIENT.........................................:

—

Clinical effects with respect to characteristicstaken or surface pressure documented in theRISK MANAGEMENT FILE

(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

APPLIED PARTS surface temperature of equal toor less than 41°C

N/A

Analysis documented in the RISK MANAGEMENTFILE show that APPLIED PART temperatures arenot affected by operation of the ME EQUIPMENTincluding SINGLE FAULT CONDITIONS.Measurement of APPLIED PART temperatureaccording to 11.1.3 is not conducted................ :


N/A

Surfaces of APPLIED PARTS that are cooledbelow ambient temperatures evaluated in theRISK MANAGEMENT PROCESS.....................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

11.1.3 Measurements not made when engineeringjudgment and rationale by MANUFACTURERindicated temperature limits could not exceed,as documented in RISK MANAGEMENT FILE.......... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

See appended Table 11.1.3dand RMF Reference to specificRISKS:(ISO 14971 Cl.__)

N/A

Test corner not used where engineeringjudgment and rationale by MANUFACTURERindicated test corner will not impactmeasurements, as documented in RISKMANAGEMENT FILE...................................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

Probability of occurrence and duration ofcontact for parts likely to be touched and forAPPLIED PARTS documented in RISK MANAGEMENTFILE............................................................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


P


EN 60601-1


e) Where thermal regulatory devices make thismethod inappropriate, alternative methods formeasurement are justified in the RISKMANAGEMENT FILE.......................................................:


N/A

11.1.4 GUARDS preventing contact with hot or coldaccessible surfaces removable only with aTOOL

N/A

11.2 Fire prevention P

11.2.1 ENCLOSURE has strength and rigidity necessaryto prevent a fire and met mechanical strengthtests for ENCLOSURES in 15.3

P

11.2.2 Me equipment and me systems used in conjunction with OXYGEN RICHENVIRONMENTS

N/A

11.2.2.1 RISK of fire in an OXYGEN RICH ENVIRONMENTreduced by means limiting spread of................. :


a) No sources of ignition discovered in anOXYGEN RICH ENVIRONMENT under any of thefollowing conditions

N/A

1) when temperature of material raised to itsignition temperature

N/A

2) when temperatures affected solder or solderjoints causing loosening, short circuiting, orother failures causing sparking or increasingmaterial temperature to its ignition temperature

N/A

3) when parts affecting safety cracked orchanged outer shape exposing temperatureshigher than 300°C or sparks due to overheating

N/A

4) when temperatures of parts or componentsexceeded 300°C, atmosphere was 100 %oxygen, contact material solder, and fuelcotton

N/A

5) when sparks provided adequate energy forignition by exceeding limits of Figs 35 to 37(inclusive), atmosphere was 100 % oxygen,contact material solder, and fuel cotton

N/A

Deviations from worst case limits in 4) and 5)above based on lower oxygen concentrationsor less flammable fuels justified anddocumented in RISK MANAGEMENT FILE................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

Alternative test in this clause did not identifyexistence of ignition sources at highestvoltage or current, respectively........................... :


A safe upper limit determined by dividingupper limit of voltage or current, respectively,with safety margin factor of three.......................:

N/A


EN 60601-1


b) RESIDUAL RISK of fire in an OXYGEN RICHENVIRONMENT as determined by application ofRISK MANAGEMENT PROCESS is based onfollowing configurations, or in combination ...:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

1) Electrical components in an OXYGEN RICHENVIRONMENT provided with power supplieshaving limited energy levels lower than thoseconsidered sufficient for ignition in 11.2.2.1 a)as determined by examination, measurementor calculation of power, energy, andtemperatures in NORMAL and SINGLE FAULTCONDITIONS identified in 11.2.3............................... :

See appended Tables 4.11,11.1.1, 11.2.2.1 and 13.2

N/A

2) Max oxygen concentration measured until itdid not exceed 25 % in ventilatedcompartments with parts that can be a sourceof ignition only in SINGLE FAULT CONDITION andcan be penetrated by oxygen due to anundetected leak (%)................................................ :

N/A

3) A compartment with parts or componentsthat can be a source of ignition only underSINGLE FAULT CONDITION separated from anothercompartment containing an OXYGEN RICHENVIRONMENT by sealing all joints and holes forcables, shafts, or other purposes

N/A

Effect of possible leaks and failures underSINGLE FAULT CONDITION that could causeignition evaluated using a RISK ASSESSMENT todetermine maintenance intervals byexamination of documentation and RISKMANAGEMENT FILE....................................................... :


4) Fire initiated in ENCLOSURE of electricalcomponents in a compartment with OXYGENRICH ENVIRONMENT that can become a source ofignition only under SINGLE FAULT CONDITIONSself-extinguished rapidly and no hazardousamount of toxic gases reached PATIENT asdetermined by analysis of gases ....................... :


11.2.2.2 RISK of ignition did not occur, and oxygenconcentration did not exceed 25% inimmediate surroundings due to location ofexternal exhaust outlets of an OXYGEN RICHENVIRONMENT

N/A

11.2.2.3 Electrical connections within a compartmentcontaining an OXYGEN RICH ENVIRONMENT underNORMAL USE did not produce sparks

N/A

– Screw-attachments protected againstloosening during use by varnishing, use ofspring washers, or adequate torques

N/A


EN 60601-1


– Soldered, crimped, and pin-and-socketconnections of cables exiting ENCLOSUREinclude additional mechanical securing means

N/A

11.2.3 SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS ME EQUIPMENTand ME SYSTEMS considered

N/A

– Failure of a ventilation system constructed inaccordance with 11.2.2.1 b) 2).............................. :

N/A

– Failure of a barrier constructed inaccordance with 11.2.2.1 b) 3).............................. :

N/A

– Failure of a component creating a source ofignition (as defined in 11.2.2.1 a)......................... :

N/A

– Failure of solid insulation or creepage andclearances providing equivalent of at least oneMEANS OF PATIENT PROTECTION but less than twoMEANS OF PATIENT PROTECTION that could createa source of ignition defined in 11.2.2.1 a)..........:

N/A

– Failure of a pneumatic component resultingin leakage of oxygen-enriched gas..................... :

N/A

11.3 Constructional requirements for fire ENCLOSURES of ME EQUIPMENT N/A

ME EQUIPMENT met this clause for alternatemeans of compliance with selected HAZARDOUSSITUATIONS and fault conditions in 13.1.2........... :

P

Constructional requirements were met, or P

- constructional requirements specificallyanalysed in RISK MANAGEMENT FILE ...................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

Justification, when requirement not met........... : Specific requirement that is notmet:__Justification:__

N/A

a) Flammability classification of insulated wirewithin fire ENCLOSURE is FV-1, or better, basedon IEC 60695 series as determined byexamination of data on materials.........................:


Flammability classification of connectors,printed circuit boards, and insulating materialon which components are mounted is FV-2, orbetter, based on IEC 60695-11-10 as decided byexamination of materials data...............................:


If no FV Certification, FV tests based on IEC60695-11-10 conducted on 3 samples ofcomplete parts (or sections of it), includingarea with min. thickness, ventilation openings

N/A

b) Fire ENCLOSURE met following: P


EN 60601-1


1) No openings at bottom or, as specified inFig 39, constructed with baffles as in Fig 38, ormade of perforated metal as in Table 25, or ametal screen with a mesh 2 × 2 mm centre tocentre and wire diameter of at least 0.45 mm

P

2) No openings on the sides within the areaincluded within the inclined line C in Fig 39

P

3) ENCLOSURE, baffles, and flame barriers haveadequate rigidity and are made of appropriatemetal or of non-metallic materials....................... :


11.4 ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics N/A

ME EQUIPMENT, ME SYSTEMS and parts describedin ACCOMPANYING DOCUMENTS for use withflammable with Annex G

N/A

11.5 ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammableagents

N/A

MANUFACTURER’S RISK MANAGEMENT PROCESSaddresses possibility of fire and associatedmitigations as confirmed by examination ofRISK MANAGEMENT FILE...............................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

11.6 Overflow, spillage, leakage, ingress of water or particulate matter, cleaning,disinfection, sterilization and compatibility with substances used with the MEEQUIPMENT

P

11.6.1 Sufficient degree of protection providedagainst overflow, spillage, leakage, ingress ofwater or particulate matter, cleaning,disinfection and sterilization, and compatibilitywith substances used with ME EQUIPMENT.........:


11.6.2 Overflow in ME EQUIPMENT N/A

ME EQUIPMENT incorporates a reservoir or liquidstorage that did not wet any MEANS OFPROTECTION, nor result in the loss of BASICSAFETY or ESSENTIAL PERFORMANCE........................:

See Appended Table 11.6.1 N/A

Maximum fill level is indicated by marking onthe ME EQUIPMENT and a warning or safetynotice is given, no HAZARDOUS SITUATION (asspecified in 13.1) or unacceptable RISK due tooverflow developed when the reservoir orliquid storage chamber is filled to its maximumcapacity and the TRANSPORTABLE ME EQUIPMENTis tilted through an angle of 10°, or for MOBILEME EQUIPMENT exceeding 45 kg, is moved over athreshold as described in 9.4.2.4.3.

N/A


EN 60601-1


No warning or safety notice provided regardingthe maximum fill level, no HAZARDOUS SITUATION(as specified in 13.1) or unacceptable RISK dueto overflow developed when the reservoir orliquid storage chamber was filled to 15 %above the maximum capacity and theTRANSPORTABLE ME EQUIPMENT was tiltedthrough an angle of 10°, or in MOBILE MEEQUIPMENT exceeding 45 kg, was moved over athreshold as described in 9.4.2.4.3.

N/A

11.6.3 Spillage on ME EQUIPMENT and ME SYSTEM N/A

ME EQUIPMENT and ME SYSTEMS handling liquidsconstructed that spillage does not wet parts asdetermined by review of the RISK MANAGEMENTFILE and test ............................................................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)

See appended Tables 11.6.1;8.7, 8.8.3 and RMF Referenceto specific RISK:

(ISO 14971 Cl. __)

N/A

RISK ANALYSIS identifies the type of liquid,volume, duration and location of the spill.........:

N/A

11.6.5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS N/A

ME EQUIPMENT with IP Code placed in leastfavourable position of NORMAL USE andsubjected to tests of IEC 60529 (IP Code)........ :

See Appended Table 11.6.1 N/A

ME EQUIPMENT met dielectric strength andLEAKAGE CURRENT tests and there were nobridging of insulation or electrical componentsthat could result in the loss of BASIC SAFETY orESSENTIAL PERFORMANCE in NORMAL CONDITION orin combination with a SINGLE FAULT CONDITION.. :

See appended Tables 8.78.8.3

N/A

11.6.6 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS P

ME EQUIPMENT/ME SYSTEM and their parts andACCESSORIES cleaned or disinfected usingmethods specified in instructions for use.........:

See Appended Tables 11.6.1,8.7, and 8.8.3

P

Effects of multiple cleanings/disinfectionsduring EXPECTED SERVICE LIFE of EQUIPMENTevaluated by MANUFACTURER.................................. :

P

11.6.7 Sterilization of ME EQUIPMENT and ME SYSTEMS N/A

ME EQUIPMENT, ME SYSTEMS and their parts orACCESSORIES intended to be sterilized assessedand documented and compliant with tests....... :

See appended Tables 8.78.8.3, and 11.6.1

N/A

RISK MANAGEMENT FILE includes an assessmentof the RISKS associated with any deteriorationfollowing sterilization.............................................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

11.6.8 RISKS associated with compatibility ofsubstances used with ME EQUIPMENT addressedin RISK MANAGEMENT PROCESS................................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


P


EN 60601-1


11.7 ME EQUIPMENT, ME SYSTEM, and ACCESSORIEScoming into direct or indirect contact withbiological tissues, cells, or body fluidsassessed and documented

N/A

11.8 Interruption and restoration of power supplydid not result in a loss of BASIC SAFETY orESSENTIAL PERFORMANCE

P

12 ACCURACY OF CONTROLS AND INSTRUMENTS AND PROTECTIONAGAINST HAZARDOUS OUTPUTS

P

12.1 RISKS associated with accuracy of controls andinstruments stated.................................................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


P

12.2 RISK of poor USABILITY, including identification,marking, and documents addressed in aUSABILITY ENGINEERING............................................. :

See Report based on IEC60601-1-6

P

12.3 MANUFACTURER implemented an ALARM SYSTEMcompliant with IEC 60601-1-8. ........................... :

See Report based on IEC60601-1-8

N/A

12.4 Protection against hazardous output N/A

12.4.1 RISKS associated with hazardous output arisingfrom intentional exceeding of safety limitsaddressed in RISK MANAGEMENT PROCESS..............:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

12.4.2 - need for indication associated withhazardous output addressed in RISKMANAGEMENT PROCESS................................................ :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

12.4.3 RISKS associated with accidental selection ofexcessive output values for ME EQUIPMENT witha multi-purpose unit addressed in RISKMANAGEMENT PROCESS..............................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

12.4.4 RISKS associated with incorrect outputaddressed in RISK MANAGEMENT PROCESS........... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

12.4.5 Diagnostic or therapeutic radiation N/A

12.4.5.1 Adequate provisions to protect OPERATORS,PATIENTS, other persons and sensitive devicesin vicinity of unwanted or excessive radiation

N/A

Radiation safety ensured by compliance withrequirements of appropriate standards

N/A

12.4.5.2 ME EQUIPMENT and ME SYSTEMS designed toproduce X-radiation for diagnostic imagingpurposes complied with IEC 60601-1-3.............:

See IEC 60601-1-3 Report N/A


EN 60601-1


12.4.5.3 RISKS associated with radiotherapy addressedin RISK MANAGEMENT PROCESS as...........................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

12.4.5.4 RISKS associated with ME EQUIPMENT producingdiagnostic or therapeutic radiation other thandiagnostic X-rays and radiotherapy addressedin RISK MANAGEMENT PROCESS as...........................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

12.4.6 RISKS associated with diagnostic or therapeuticacoustic pressure addressed in RISKMANAGEMENT.............................................................. :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

13 HAZARDOUS SITUATIONS AND FAULT CONDITIONS P

13.1 Specific HAZARDOUS SITUATIONS P

13.1.2 Emissions, deformation of ENCLOSURE or exceeding maximum temperature P

– Emission of flames, molten metal, poisonousor ignitable substance in hazardous quantitiesdid not occur

P

– Deformation of ENCLOSURE impairingcompliance with 15.3.1 did not occur

P

– Temperatures of APPLIED PARTS did notexceed allowable values in Table 24...................:


– Temperatures of ME EQUIPMENT parts that arenot APPLIED PARTS likely to be touched did notexceed values in Table 23...................................... :


–Allowable values for “other components andmaterials” in Table 22 times 1.5 minus 12.5 °Cwere not exceeded

P

Limits for windings in Tables 26, 27, and 31 notexceeded

N/A

Table 22 not exceeded in all other cases P

Temperatures measured according to 11.1.3 P

SINGLE FAULT CONDITIONS in 4.7, 8.1 b), 8.7.2, and13.2.2 relative to emission of flames, moltenmetal, or ignitable substances, not applied toparts and components where:

P

– Supply circuit was unable to supply 15 Wone minute after 15 W drawn from supplycircuit in SINGLE FAULTCONDITION ..................................... :


- or secondary circuits mounted on materialswith a minimum flame rating of FV1, and

N/A

- Secondary circuits energized by less than 60Vdc, 42.4 Vpeak in NC and SFC, and

N/A


EN 60601-1


- Secondary circuits limited to 100 VA or 6000 Jin NC and SFC, and

N/A

- Wire insulation in secondary circuits of typesPVC, TFE, PTFE, FEP, polychloroprene orpolybromide

N/A

- or components in the circuit have HIGHINTEGRITY CHARACTERISTICS................................ :


– or parts and components completelycontained within a fire ENCLOSURE complyingwith 11.3 as verified by review of designdocumentation

P

After tests of this Clause, settings of THERMALCUT-OUTS and OVER-CURRENT RELEASES did notchange sufficiently to affect their safetyfunction


13.1.3 – limits for LEAKAGE CURRENT in SINGLE FAULTCONDITION did not exceed........................................:


– voltage limits for ACCESSIBLE PARTS includingAPPLIED PARTS did not exceed............................. :


13. 2 SINGLE FAULT CONDITIONS P

13.2.1 During the application of the SINGLE FAULTCONDITIONS listed in 13.2.2 to 13.2.13 (inclusive),the NORMAL CONDITIONS identified in 8.1 a) alsoapplied in the least favourable combination

P

ME EQUIPMENT complied with 13.2.2 -13.2.12...... : See appended Table 13.2 P

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with leakage of liquid in aSINGLE FAULT CONDITION.......................................:(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


P

RISK MANAGEMENT FILE defines the appropriatetest conditions....................................................:

P

13.2.13 ME EQUIPMENT remained safe after tests of13.2.13.2 to 13.2.13.4, and cooling down towithin 3 C of test environment temperature

N/A

ME EQUIPMENT examined for compliance orappropriate tests such as dielectric strength ofmotor insulation according to 8.8.3 conducted

N/A

For insulation of thermoplastic materials reliedupon as a MEANS OF PROTECTION, the ball-pressure test specified in 8.8.4.1 a) performed ata temperature 25 °C higher than temperature ofinsulation measured during tests of 13.2.13.2 to13.2.13.4 (inclusive).

N/A

13.2.13.2 ME EQUIPMENT with heating elements N/A


EN 60601-1


a 1) thermostatically controlled ME EQUIPMENTwith heating elements for building-in, r forunattended operation, or with a capacitor notprotected by a fuse connected in parallel withTHERMOSTAT contacts met tests

N/A

a 2) ME EQUIPMENT with heating elements RATEDfor non-CONTINUOUS OPERATION met tests

N/A

a 3) other ME EQUIPMENT with heating elementsmet test

N/A

When more than one test was applicable tosame ME EQUIPMENT, tests performedconsecutively

N/A

Heating period stopped when a heatingelement or an intentionally weak part of a non-SELF-RESETTING THERMAL CUT-OUT ruptured, orcurrent interrupted before THERMAL STABILITYwithout possibility of automatic restoration

N/A

Test repeated on a second sample wheninterruption was due to rupture of a heatingelement or an intentionally weak part

N/A

Both samples met 13.1.2, and open circuitingof a heating element or an intentionally weakpart in second sample not considered a failureby itself

N/A

b) ME EQUIPMENT with heating elements withoutadequate heat discharge, and supply voltageset at 90 or 110 % of RATED supply voltage,least favourable of the two (V)............................. :

N/A

Operating period stopped when a non-SELF-RESETTING THERMAL CUT-OUT operated, or currentinterrupted without possibility of automaticrestoration before THERMAL STABILITY

N/A

ME EQUIPMENT switched off as soon as THERMALSTABILITY established and allowed to cool toroom temperature when current not interrupted

N/A

Test duration was equal to RATED operatingtime for non-CONTINUOUS OPERATION

N/A

c) Heating parts of ME EQUIPMENT tested with MEEQUIPMENT operated in NORMAL CONDITION at 110% of RATED supply voltage and as in 11.1, and

N/A

1) Controls limiting temperature in NORMALCONDITION disabled, except THERMAL CUT-OUTS

N/A

2) When more than one control provided, theywere disabled in turn

N/A

3) ME EQUIPMENT operated at RATED DUTY CYCLEuntil THERMAL STABILITY achieved, regardless ofRATED operating time

N/A


EN 60601-1


13.2.13.3 ME EQUIPMENT with motors P

a 1) For the motor part of the ME EQUIPMENT,compliance checked by tests of 13.2.8- 13.2.10,13.2.13.3 b), 13.2.13.3 c), and 13.2.13.4, asapplicable

P

To determine compliance with 13.2.9 and13.2.10 motors in circuits running at 42.4 Vpeak a.c./ 60 V d.c. or less are covered with asingle layer of cheesecloth which did not igniteduring the test

P

a 2) Tests on ME EQUIPMENT containing heatingparts conducted at prescribed voltage withmotor & heating parts operated simultaneouslyto produce the least favourable condition

N/A

a 3) Tests performed consecutively when moretests were applicable to the same ME EQUIPMENT

N/A

b) Motor met running overload protection testof this clause when:

N/A

1) it is intended to be remotely or automaticallycontrolled by a single control device with noredundant protection, or

N/A

2) it is likely to be subjected to CONTINUOUSOPERATION while unattended

N/A

Motor winding temperature determined duringeach steady period and maximum value did notexceed Table 27 (Insulation Class, Maximumtemperature measured C)....................................:

N/A

Motor removed from ME EQUIPMENT and testedseparately when load could not be changed inappropriate steps

N/A

Running overload test for motors operating at42.4 V peak a.c./60 V d.c. or less performedonly when examination and review of designindicated possibility of an overload

N/A

Test not conducted where electronic drivecircuits maintained a substantially constantdrive current

N/A

Test not conducted based on otherjustifications (justification)................................... :

N/A

c) ME EQUIPMENT with 3-phase motors operatedwith normal load, connected to a 3-phaseSUPPLY MAINS with one phase disconnected, andperiods of operation per 13.2.10

N/A

13.2.13.4 ME EQUIPMENT RATED for NON-CONTINUOUS OPERATION N/A


EN 60601-1


ME EQUIPMENT (other than HAND-HELD) operatedunder normal load and at RATED voltage or atupper limit of RATED voltage range untilincrease in temperature was 5 °C in one hour,or a protective device operated

N/A

When a load-reducing device operated inNORMAL USE, test continued with ME EQUIPMENTrunning idle

N/A

Motor winding temperatures did not exceedvalues in 13.2.10...................................................... :

N/A

Insulation Class....................................................... : —

Maximum temperature measured (C)............... : —

14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) P

14.1 Requirements in 14.2 to 14,12 not applied toPEMS when it provides no functionalitynecessary for BASIC SAFETY or ESSENTIALPERFORMANCE, or

N/A

- when application of RISK MANAGEMENT showedthat failure of PESS does not lead tounacceptable RISK....................................................:

P

RISK MANAGEMENT FILE contains an assessmentof RISKS associated with the failure of the PESS:(ISO 14971 Cl. 4.2-4.4, 5)

RMF Reference to specificRISKS:ISO 14971 Cl. _4.5_)

P

Requirements of 14.13 not applied to PEMSintended to be incorporated into an IT NETWORK

N/A

When the requirements of 14.2 to 14.13 apply,the requirements of IEC 62304:2006 clause 4.3,5, 7, 8 and 9 apply for the development ormodification of software of each PESS

N/A

Software development process for SoftwareClassification applied in accordance withClause 4.3 of IEC 62304......................................... :

Software Class: __ N/A

Software development process appliedaccording to Clause 5 of IEC 62304................... :

Refer to Attachment- Software N/A

Software development process for Softwarerisk management applied according to Clause7 of IEC 62304...........................................................:

Refer to Attachment-Software N/A

Software development process ConfigurationManagement applied according to Clause 8 ofIEC 62304................................................................... :


Software development process for SoftwareProblem Resolution applied according toClause 9 of IEC 62304.............................................:



EN 60601-1


14.2 Documents required by Clause 14 reviewed,approved, issued and revised according to aformal document control process...................... :

P

14.3 RISK MANAGEMENT plan required by 4.2.2includes reference to PEMS VALIDATION plan

P

14.4 A PEMS DEVELOPMENT LIFE-CYCLE including a setof defined milestones has been documented

N/A

At each milestone, activities to be completed,and VERIFICATION methods to be applied toactivities have been defined

N/A

Each activity including its inputs and outputsdefined, and each milestone identifies RISKMANAGEMENT activities that must be completedbefore that milestone

N/A

PEMS DEVELOPMENT LIFE-CYCLE tailored for aspecific development by making plansdetailing activities, milestones, and schedules

N/A

PEMS DEVELOPMENT LIFE-CYCLE includesdocumentation requirements

N/A

14.5 A documented system for problem resolutionwithin and between all phases and activities ofPEMS DEVELOPMENT LIFE-CYCLE has beendeveloped and maintained

P

14.6 RISK MANAGEMENT PROCESS P

14.6.1 MANUFACTURER considered HAZARDS associatedwith software and hardware aspects of PEMSincluding those associated with theincorporating PEMS into an IT-NETWORK,components of third-party origin, legacysubsystems when compiling list of known orforeseeable HAZARDS................................................ :

N/A

RISK MANAGEMENT FILE includes known orforeseeable HAZARDS associated with software,hardware, incorporation of the PEMS into an IT-NETWORK, components of 3rd party origin andlegacy subsystems.................................................. :(ISO 14971 Cl. 4.3)

RMF Reference to specificHAZARDS:(ISO 14971 Cl. __)

N/A

14.6.2 Suitably validated tools and PROCEDURESassuring each RISK CONTROL measure reducesidentified RISK(S) satisfactorily provided inaddition to PEMS requirements in Clause 4.2.2. :

P

RISK MANAGEMENT FILE documents the suitabilityof tools and procedures to validate each RISKCONTROL measure......................................................:(ISO 14971 Cl. 6.1)

RMF Reference to specificRISKS:(ISO 14971 Cl. _6.1_)

P


EN 60601-1


14.7 A documented requirement specification forPEMS and each of its subsystems (e.g. for aPESS) which includes ESSENTIAL PERFORMANCEand RISK CONTROL measures implemented bythat system or subsystem......................................:(ISO 14971 Cl. 6.3)

RMF Reference to specificRISK CONTROLS:(ISO 14971 Cl. _6.3_)

P

14.8 An architecture satisfying the requirement isspecified for PEMS and each of subsystems......:(ISO 14971 Cl. 6.3)


P

14.9 Design is broken up into sub systems anddescriptive data on design environmentdocumented............................................................... :

P

14.10 A VERIFICATION plan containing the specifiedinformation used to verify and documentfunctions implementing BASIC SAFETY, ESSENTIALPERFORMANCE, or RISK CONTROL measures.......... :(ISO 14971 Cl. 6.3)

RMF Reference to specificRISK CONTROLS:(ISO 14971 Cl. __)

P

– milestone(s) when VERIFICATION is to beperformed for each function

P

– selection and documentation of VERIFICATIONstrategies, activities, techniques, andappropriate level of independence of thepersonnel performing the VERIFICATION

P

– selection and utilization of VERIFICATION tools P

– coverage criteria for VERIFICATION P

The VERIFICATION performed according to theVERIFICATION plan and results of the VERIFICATIONactivities documented

P

14.11 A PEMS VALIDATION plan containing validation ofBASIC SAFETY & ESSENTIAL PERFORMANCE .............:

P

The PEMS VALIDATION performed according tothe PEMS VALIDATION plan with results of PEMSVALIDATION activities and methods used forPEMS VALIDATION documented

N/A

The person with overall responsibility for PEMSVALIDATION is independent

P

All professional relationships of members ofPEMS VALIDATION team with members of designteam documented in RISK MANAGEMENT FILE(ISO 14971 Cl. 6.3)


P

14.12 Continued validity of previous designdocumentation assessed under a documentedmodification/change PROCEDURE

P

Software Classification for Software changesapplied in accordance with Clause 4.3 of IEC62304............................................................................:

Software Class:__ N/A


EN 60601-1


Software Process for Software changes appliedaccording to Clause 5 of IEC 62304.................... :

N/A

RISK MANAGEMENT for Software changes appliedaccording to Clause 7 of IEC 62304.................... :

N/A

Configuration management of softwarechanges applied per Clause 8 of IEC 62304......:

N/A

Problem resolution for Software changesapplied according to Clause 9 of IEC 62304..... :

N/A

14.13 For PEMS incorporated into an IT-NETWORK notVALIDATED by the PEMS MANUFACTURER,instructions made available for implementingthe connection include the following................. :

N/A

a) Purpose of the PEMS connection to an IT-NETWORK

N/A

b) required characteristics of the IT-NETWORK N/A

c) required configuration of the IT-NETWORK N/A

d) technical specifications of the networkconnection, including security specifications

N/A

e) intended information flow between the PEMS,the IT-NETWORK and other devices on the IT-NETWORK, and the intended routing through theIT-NETWORK

N/A

f) a list of HAZARDOUS SITUATIONS resulting fromfailure of the IT-NETWORK to provide the requiredcharacteristics(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.3)

RMF Reference to specifichazardous situations:(ISO 14971 Cl. __)

N/A

ACCOMPANYING DOCUMENTS for the RESPONSIBLE ORGANIZATION include thefollowing:

N/A

– statement that connection to IT-NETWORKSincluding other equipment could result inpreviously unidentified RISKS TO PATIENTS,OPERATORS or third parties

N/A

– Notification that the RESPONSIBLEORGANIZATION should identify, analyse, evaluateand control these RISKS

N/A

– Notification that changes to the IT-NETWORKcould introduce new RISKS that requireadditional analysis

N/A

- Changes to the IT-NETWORK include:- changes in network configuration- connection of additional items- disconnection of items- update of equipment- upgrade of equipment

N/A


EN 60601-1


15 CONSTRUCTION OF ME EQUIPMENT P

15.1 RISKS associated with arrangement of controlsand indicators of ME EQUIPMENT addressedthrough the application of a USABILITYENGINEERING PROCESS................................................:

See Attached IEC 60601-1-6 P

15.2 Parts of ME EQUIPMENT subject to mechanicalwear, electrical, environmental degradation orageing resulting in unacceptable RISK whenunchecked for a long period, are accessible forinspection, replacement, and maintenance

N/A

Inspection, servicing, replacement, andadjustment of parts of ME EQUIPMENT can easilybe done without damage to or interference withadjacent parts or wiring

N/A

15.3 Mechanical strength P

15.3.1 Mould stress relief, push, impact, drop, andrough handling tests did not result in loss ofBASIC SAFETY or ESSENTIAL PERFORMANCE

P

15.3.2 Push test conducted............................................... : See Appended Table 15.3 P

No damage resulting in an unacceptable RISKsustained

P

15.3.3 Impact test conducted............................................ : See Appended Table 15.3 N/A


N/A

15.3.4 Drop test P

15.3.4.1 Sample of HAND-HELD ME EQUIPMENT,ACCESSORIES and HAND-HELD part with SAFEWORKING LOAD tested................................................ :

See Appended Table 15.3 P

No unacceptable RISK resulted P

15.3.4.2 Sample of PORTABLE ME EQUIPMENT, ACCESSORIESand PORTABLE part with SAFE WORKING LOADwithstood stress as demonstrated by test....... :

See Appended Table 15.3 N/A


N/A

15.3.5 MOBILE ME EQUIPMENT and MOBILE part with SAFEWORKING LOAD and in most adverse condition inNORMAL USE passed Rough Handling tests........:

See Appended Table 15.3 N/A


N/A

15.3.6 Examination of ENCLOSURE made from mouldedor formed thermoplastic material indicated thatmaterial distortion due to release of internalstresses by moulding or forming operationswill not result in an unacceptable RISK

P


EN 60601-1


Mould-stress relief test conducted by placingone sample of complete ME EQUIPMENT,ENCLOSURE or a portion of larger ENCLOSURE, for7 hours in a circulating air oven at 10°C overthe max temperature measured on ENCLOSUREin 11.1.3, but no less than 70 °C............................ :

N/A

No damage resulting in an unacceptable RISK N/A

15.3.7 INTENDED USE, EXPECTED SERVICE LIFE, andconditions for transport and storage weretaken into consideration for selection andtreatment of materials used in construction ofME EQUIPMENT

P

Based on review of EQUIPMENT, ACCOMPANYINGDOCUMENTS, specifications and processing ofmaterials, and MANUFACTURER’S relevant testsor calculations, corrosion, ageing, mechanicalwear, degradation of biological materials dueto bacteria, plants, animals and the like, willnot result in an unacceptable RISK

P

15.4 ME EQUIPMENT components and general assembly P

15.4.1 Incorrect connection of accessible connectors,removable without a TOOL, prevented where anunacceptable RISK exists,....................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


P

a) Plugs for connection of PATIENT leads orPATIENT cables cannot be connected to outletson same ME EQUIPMENT intended for otherfunctions,....................................................................:

See attachment No. __ N/A

b) Medical gas connections on ME EQUIPMENTfor different gases to be operated in NORMALUSE are not interchangeable inspection.............:

See attachment No. __ N/A

15.4.2 Temperature and overload control devices N/A

15.4.2.1 a) THERMAL CUT-OUTS and OVER-CURRENTRELEASES with automatic resetting not used inME EQUIPMENT when their use could lead to aHAZARDOUS SITUATION................................................ :(ISO 14971 Cl. 4.2-4.4, 5)


N/A

b) THERMAL CUT-OUTS with a safety function withreset by a soldering not fitted in ME EQUIPMENT

N/A

c) An additional independent non-SELF-RESETTING THERMAL CUT-OUT is provided..............:(ISO 14971 Cl. 4.2-4.4)


N/A

d) Operation of THERMAL CUT-OUT or OVERCURRENT RELEASE doesn’t result in a HAZARDOUSSITUATION or loss of ESSENTIAL PERFORMANCE ....:(ISO 14971 Cl. 4.2-4.4)


N/A


EN 60601-1


e) Capacitors or other spark-suppressiondevices not connected between contacts ofTHERMAL CUT-OUTS

N/A

f) Use of THERMAL CUT-OUTS or OVER-CURRENTRELEASES do not affect safety as verified byfollowing tests

N/A

- Positive temperature coefficient devices)complied with IEC 60730-1: 2010, Clauses 15,17, J.15, and J.17

N/A

- ME EQUIPMENT containing THERMAL CUT-OUTSand OVER-CURRENT RELEASES operated under theconditions of Clause 13.......................................... :


- SELF-RESETTING THERMAL CUT-OUTS and OVER-CURRENT RELEASES including circuitsperforming equivalent functions Certifiedaccording to appropriate standards.....................

N/A

- In the absence of Certification in accordancewith IEC standards, SELF-RESETTING THERMALCUT-OUTS and OVER-CURRENT RELEASES includingcircuits performing equivalent functionsoperated 200 times

N/A

Manual reset THERMAL CUT-OUTS and OVER-CURRENT RELEASES Certified in accordance withappropriate IEC standards

N/A

manual reset THERMAL CUT-OUTS and OVER-CURRENT RELEASES operated 10 times

N/A

Thermal protective devices tested separatelyfrom ME EQUIPMENT when engineering judgmentindicated test results would not be impacted

N/A

g) Protective device incorporating a fluid filledcontainer with heating means, operated whenheater switched on with container empty andprevented an unacceptable RISK due tooverheating

N/A

h) ME EQUIPMENT with tubular heating elementsprovided with protection against overheating. :(ISO 14971 Cl. 4.2-4.4)


N/A

15.4.2.2 Temperature settings clearly indicated whenmeans provided to vary setting of THERMOSTATS

N/A

15.4.3 Batteries P

15.4.3.1 Battery housings provided with ventilation... :(ISO 14971 Cl. 4.2-4.4)


P

Battery compartments designed to preventaccidental short circuiting

P

15.4.3.2 Means provided to prevent incorrectconnection of polarity............................................ :

P


EN 60601-1


RISK MANAGEMENT FILE includes an assessmentof RISKS associated with incorrect connectionor replacement of batteries...................................:(ISO 14971 Cl. 4.2-4.4)


P

15.4.3.3 Overcharging of battery prevented by virtue ofdesign......................................................................... :

N/A

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with overcharging ofbatteries..................................................................... :(ISO 14971 Cl. 4.2-4.4)


N/A

15.4.3.4 Primary lithium batteries comply with IEC80086-4

N/A

Secondary lithium batteries comply with IEC62133

N/A

15.4.3.5 A properly RATED protective device providedwithin INTERNAL ELECTRICAL POWER SOURCE toprotect against fire.................................................. :

N/A

Protective device has adequate breakingcapacity

N/A

Justification for OVER-CURRENT RELEASES orFUSE exclusion is documented

N/A

Short circuit test between the positive andnegative poles of an INTERNAL ELECTRICALPOWER SOURCE between the output andprotective device(s) omitted where 2 MOOPsprovided, or

N/A

Short circuit between the positive and negativepoles of an INTERNAL ELECTRICAL POWER SOURCEbetween the output and protective device(s)does not result in any HAZARDOUS SITUATION

N/A

15.4.4 Indicator lights provided to indicate MEEQUIPMENT is ready for............................................ :

N/A

An additional indicator light provided on MEEQUIPMENT with a stand-by state or a warm-upstate exceeding 15 s,

N/A

Indicator lights provided on ME EQUIPMENTincorporating non-luminous heaters to indicateheaters are operational

N/A

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with the use of indicatorlights for EQUIPMENT incorporating non-luminous heaters.....................................................:(ISO 14971 Cl. 4.2-4.4)


N/A

Requirement not applied to heated stylus-pensfor recording purposes

N/A

Indicator lights provided on ME EQUIPMENT toindicate an output exists

N/A


EN 60601-1


Colours of indicator lights complied with 7.8.1 N/A

Charging mode visibly indicated N/A

15.4.5 RISKS associated with pre-set controlsaddressed in RISK MANAGEMENT PROCESS........... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

15.4.6 Actuating parts of controls of ME EQUIPMENT P

15.4.6.1 a) Actuating parts cannot be pulled off orloosened during NORMAL USE

P

b) Controls secured so that the indication ofany scale always corresponds to the positionof the control

N/A

c) Incorrect connection prevented by adequateconstruction when it could be separatedwithout use of a TOOL

N/A

When torque values per Table 30 appliedknobs did not rotate ............................................. :


Tests conducted with no unacceptable RISK ..: See appended Table 15.4.6 N/A

15.4.6.2 Stops on rotating/ movable parts of controlsare of adequate mechanical strength .............. :


Torque values in Table 30 applied...................... : See appended Table 15.4.6 N/A

No unexpected change of the controlledparameter when tested.......................................... :


15.4.7 Cord-connected HAND-HELD and foot-operated control devices N/A

15.4.7.1 a) HAND-HELD control devices of ME EQUIPMENTcomplied with 15.3.4.1

N/A

b) Foot-operated control device supported anactuating force of 1350 N in its position ofNORMAL USE with no damage..................................:

N/A

15.4.7.2 Control device of HAND-HELD and foot-operatedcontrol devices turned in all possible abnormalpositions and placed on a flat surface ............. :

N/A

No unacceptable RISK caused by changingcontrol setting when accidentally placed in anabnormal position

N/A

15.4.7.3 a) Foot-operated control device is at least ratedIPX1............................................................................... :

See appended Table 11.6.1IP Code = __

N/A

b) ENCLOSURE of foot operated control devicescontaining electrical circuits is at least IPX6..... :

See appended Table 11.6.1IP Code = __

N/A

15.4.8 Aluminium wires less than 16 mm2 in cross-sectional area are not used

N/A

15.4.9 a) Oil container in PORTABLE ME EQUIPMENTallows for expansion of oil and is adequatelysealed

N/A


EN 60601-1


b) Oil containers in MOBILE ME EQUIPMENT sealedto prevent loss of oil during transport

N/A

A pressure-release device operating duringNORMAL USE is provided

N/A

c) Partially sealed oil-filled ME EQUIPMENT and itsparts provided with means for checking the oillevel to detect leakage

N/A

ME EQUIPMENT and technical descriptionexamined, and manual tests conducted toconfirm compliance with above requirements

N/A

15.5 MAINS SUPPLY TRANSFORMERS OF ME EQUIPMENT and transformers providingseparation in accordance with 8.5

N/A

15.5.1 Overheating N/A

15.5.1.1 Transformers of ME EQUIPMENT are protectedagainst overheating................................................. :

See appended Tables 15.5.1.2and 15.5.1.3

N/A

During tests, windings did not open, noHAZARDOUS SITUATION occurred, and maximumtemperatures of windings did not exceedvalues in Table 31

N/A

Dielectric strength test conducted after shortcircuit and overload tests .................................... :


15.5.1.2 Transformer output winding short circuited,and test continued until protective deviceoperated or THERMAL STABILITY achieved .......... :


Short circuit applied directly across outputwindings

N/A

15.5.1.3 Multiple overload tests conducted on windings.......................................................................................:


15.5.2 Transformers operating at a frequency above1kHz tested according to clause 8.8.3................ :

N/A

Transformer windings provided with adequateinsulation

N/A

Dielectric strength tests were conducted ......: See appended Table 15.5.2 N/A

15.5.3 Transformers forming MEANS OF PROTECTION asrequired by 8.5 comply with.................................. :


- Means provided to prevent displacement ofend turns

N/A

- protective earth screens with a single turnhave insulated overlap

N/A

- Exit of wires form internal windings of toroidtransformers protected with double sleeving

N/A

- insulation between primary and secondarywindings complies with 8.8.2

N/A


EN 60601-1


- CREEPAGE DISTANCES and AIR CLEARANCEcomply with 8.9.4

N/A

16 ME SYSTEMS N/A

16.1 After installation or subsequent modification,ME SYSTEM didn’t result in an unacceptable RISK

N/A

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with installation andmodification of an ME SYSTEM................................ :(ISO 14971 Cl. 4.2-4.4, 5)


N/A

Only HAZARDS arising from combining variousequipment to form a ME SYSTEM considered

N/A

– ME SYSTEM provides the level of safety withinthe PATIENT ENVIRONMENT equivalent to MEEQUIPMENT complying with this standard

N/A

– ME SYSTEM provides the level of safety outsidePATIENT ENVIRONMENT equivalent to equipmentcomplying with their respective IEC or ISOsafety standards

N/A

– tests performed in NORMAL CONDITION, exceptas specified

N/A

– tests performed under operating conditionsspecified by MANUFACTURER of ME SYSTEM

N/A

Safety tests previously conducted onindividual equipment of ME SYSTEM according torelevant standards not repeated

N/A

RISK MANAGEMENT methods used byMANUFACTURER of an ME SYSTEM reconfigurableby RESPONSIBLE ORGANIZATION or OPERATOR

N/A

Non-ME EQUIPMENT used in ME SYSTEM compliedwith applicable IEC or ISO safety standards

N/A

Equipment relying only on BASIC INSULATION forprotection against electric shock not used inME SYSTEM

N/A

16.2 ACCOMPANYING DOCUMENTS of an ME SYSTEM N/A

Documents containing all data necessary forME SYSTEM to be used as intended byMANUFACTURER including a contact addressaccompany ME SYSTEM or modified ME SYSTEM

N/A

ACCOMPANYING DOCUMENTS regarded as a part ofME SYSTEM

N/A

a) ACCOMPANYING DOCUMENTS provided for eachitem of ME EQUIPMENT supplied byMANUFACTURER

N/A


EN 60601-1


b) ACCOMPANYING DOCUMENTS provided for eachitem of non-ME EQUIPMENT supplied byMANUFACTURER

N/A

c) the required information is provided: N/A

– specifications, instructions for use asintended by MANUFACTURER, and a list of allitems forming the ME SYSTEM

N/A

– instructions for installation, assembly, andmodification of ME SYSTEM to ensure continuedcompliance with this standard

N/A

– instructions for cleaning and, whenapplicable, disinfecting and sterilizing eachitem of equipment or equipment part formingpart of the ME SYSTEM

N/A

– additional safety measures to be appliedduring installation of ME SYSTEM

N/A

– identification of parts of ME SYSTEM suitablefor use within the PATIENT ENVIRONMENT

N/A

– additional measures to be applied duringpreventive maintenance

N/A

– a warning forbidding placement of MULTIPLESOCKET-OUTLET, when provided and it is aseparate item, on the floor

N/A

– a warning indicating an additional MULTIPLESOCKET-OUTLET or extension cord not to beconnected to ME SYSTEM

N/A

– a warning to connect only items that havebeen specified as part of ME SYSTEM or specifiedas being compatible with ME SYSTEM

N/A

– maximum permissible load for any MULTIPLESOCKET-OUTLET(S) used with ME SYSTEM

N/A

– instructions indicating MULTIPLE SOCKET-OUTLETS provided with the ME SYSTEM to be usedonly for supplying power to equipmentintended to form part of ME SYSTEM

N/A

– an explanation indicating RISKS of connectingnon-ME EQUIPMENT supplied as a part of MESYSTEM directly to wall outlet when non-MEEQUIPMENT is intended to be supplied via aMULTIPLE SOCKET-OUTLET with a separatingtransformer

N/A

– an explanation indicating RISKS of connectingany equipment supplied as a part of ME SYSTEMto MULTIPLE SOCKET-OUTLET

N/A

– permissible environmental conditions of usefor ME SYSTEM including conditions fortransport and storage

N/A


EN 60601-1


– instructions to OPERATOR not to,simultaneously, touch parts referred to in 16.4and PATIENT

N/A

d) the following instructions provided for useby RESPONSIBLE ORGANIZATION:

N/A

– adjustment, cleaning, sterilization, anddisinfection PROCEDURES

N/A

– assembly of ME SYSTEMS and modificationsduring actual service life evaluated based onthe requirements of this standard

N/A

16.3 Instructions for use of ME EQUIPMENT intendedto receive its power from other equipment in anME SYSTEM, describe the other equipment toensure compliance with these requirements

N/A

Transient currents restricted to allowable levelsfor the specified IPS or UPS................................. :

N/A

Technical description and installationinstructions specify the actual transientcurrents where an IPS or UPS is not specified

N/A

16.4 Parts of non-ME EQUIPMENT in PATIENTENVIRONMENT subject to contact by OPERATORduring maintenance, calibration, after removalof covers, connectors operated at a voltage voltage in 8.4.2 c)

N/A

16.5 Safety measures incorporating a SEPARATIONDEVICE applied when FUNCTIONAL CONNECTIONbetween ME EQUIPMENT and other items of an MESYSTEM or other systems can cause allowablevalues of LEAKAGE CURRENT to exceed

N/A

SEPARATION DEVICE has dielectric strength,CREEPAGE and CLEARANCES required for oneMEANS OF OPERATOR PROTECTION

N/A

WORKING VOLTAGE was highest voltage acrossSEPARATION DEVICE during a fault condition, butnot less than MAXIMUM MAINS VOLTAGE (V).......... :

N/A

16.6 LEAKAGE CURRENTS N/A

16.6.1 TOUCH CURRENT in NORMAL CONDITION did notexceed 100μA............................................................:


TOUCH CURRENT did not exceed 500μA in eventof interruption of any non-PERMANENTLYINSTALLED PROTECTIVE EARTH CONDUCTOR............. :


16.6.2 Current in PROTECTIVE EARTH CONDUCTOR ofMULTIPLE SOCKET-OUTLET didn’t exceed 5 mA.... :

N/A

16.6.3 PATIENT LEAKAGE CURRENT and total PATIENTLEAKAGE CURRENT of ME SYSTEM in NORMALCONDITION did not exceed values.......................... :

See appended Tables 8.78.7.4.7 and 16.6.1

N/A


EN 60601-1


16.7 ME SYSTEM complied with applicablerequirements of Clause 9.......................................:

See applicable appendedTables in section 9

N/A

16.8 Interruption and restoration power to the MESYSTEM or any part of the ME SYSTEM did notresult in a loss of BASIC SAFETY or ESSENTIALPERFORMANCE

N/A

16.9 ME SYSTEM connections and wiring N/A

16.9.1 Incorrect connection of accessible connectors,removable without a TOOL, prevented whereunacceptable RISK can result...............................:

N/A

RISK MANAGEMENT FILE includes an assessmentof RISKS associated with plugs for connectionof PATIENT leads or cables likely to be located inthe PATIENT ENVIRONMENT......................................... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

– Plugs for connection of PATIENT leads orPATIENT cables could not be connected to otheroutlets of the same ME SYSTEM likely to belocated in PATIENT ENVIRONMENT, except whenexamination of connectors and interchangingthem proved no unacceptable RISK results

N/A

Medical gas connections on the ME SYSTEM fordifferent gasses operated in NORMAL USE are notinterchangeable

N/A

16.9.2 MAINS PARTS, components and layout N/A

16.9.2.1 a) – MULTIPLE SOCKET-OUTLET only allowsconnection using a TOOL, or

N/A

– MULTIPLE SOCKET-OUTLET is of a type thatcannot accept MAINS PLUGS of any of the kindsspecified in IEC/TR 60083, or

N/A

– MULTIPLE SOCKET-OUTLET is supplied via aseparating transformer

N/A

b) – MULTIPLE SOCKET-OUTLET marked with safetysign 2 of Table D.2 visible in NORMAL USE, and

N/A

– marked either individually or in combinations,with the maximum allowed continuous outputin amperes or volt-amperes, or

N/A

– marked to indicate the equipment orequipment parts it may safely be attached to

N/A

– MULTIPLE SOCKET-OUTLET is a separate item oran integral part of ME EQUIPMENT or non-MEEQUIPMENT

N/A

c) MULTIPLE SOCKET-OUTLET complied with IEC60884-1 and the following requirements:

N/A

– CREEPAGE and CLEARANCES complied with 8.9 N/A


EN 60601-1


– It is CLASS I, and PROTECTIVE EARTH CONDUCTORis connected to earthing contacts in socket-outlets

N/A

– PROTECTIVE EARTH TERMINALS and PROTECTIVEEARTH CONNECTIONS comply with 8.6:

N/A

– ENCLOSURE complied with 8.4.2 d) N/A

– MAINS TERMINAL DEVICES and wiring compliedwith 8.11.4, when applicable

N/A

– RATINGS of components are not in conflictwith conditions of use ...........................................:


– Electrical terminals and connectors ofMULTIPLE SOCKET-OUTLETS prevent incorrectconnection of accessible connectorsremovable without a TOOL

N/A

– POWER SUPPLY CORD complied with 8.11.3 N/A

d) Additional requirements applied whenMULTIPLE SOCKET-OUTLET combined with aseparating transformer:

N/A

– Separating transformer complied with thisstandard or IEC 61558-2-1,.................................... :


– Separating transformer is CLASS I N/A

– Degree of protection against ingress of waterspecified as in IEC 60529

N/A

– Separating transformer assembly markedaccording to 7.2 and 7.3

N/A

– MULTIPLE SOCKET-OUTLET permanentlyconnected to separating transformer, orsocket-outlet of separating transformerassembly cannot accept MAINS PLUGS asidentified in IEC/TR 60083

N/A

16.9.2.2 The impedance between the protective earthpin in the MAINS PLUG and any part that isPROTECTIVELY EARTHED did not exceed 200 m

N/A

Removal of any single item of equipment in MESYSTEM will not interrupt the protective earthingof any other part without simultaneousdisconnection of electrical supply to that part

N/A

Additional PROTECTIVE EARTH CONDUCTORS canbe detachable only by use of a TOOL

N/A

16.9.2.3 Conductors connecting different items withinan ME SYSTEM protected against mechanicaldamage

N/A

17 ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT AND MESYSTEMS

N/A


EN 60601-1


RISKS associated confirmed by review............... : N/A

– electromagnetic phenomena at locationswhere ME EQUIPMENT or ME SYSTEM is to be usedas stated in ACCOMPANYING DOCUMENTS............... :

N/A

RISK MANAGEMENT FILE includes an assessmentof risks associated with the introduction ofelectromagnetic phenomena into theenvironment by the EQUIPMENT or SYSTEM.......... :(ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5)


N/A

– introduction of electromagnetic phenomenainto environment by ME EQUIPMENT or ME SYSTEMthat might degrade performance of otherdevices, electrical equipment, and systems

See IEC 60601-1-2 Report N/A

ANNEX G PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLEANESTHETIC MIXTURES

N/A

G.2 Locations and basic requirements N/A

G.2.1 Parts of CATEGORY APG ME EQUIPMENT in which aFLAMMABLE ANAESTHETIC MIXTURE WITH AIR occursare CATEGORY AP or APG ME EQUIPMENT andcomplied with G.3, G.4, and G.5

N/A

G.2.2 FLAMMABLE AESTHETIC MIXTURE WITH N/A

G.2.3 A FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN orNITROUS OXIDE

N/A

G.2.4 ME EQUIPMENT specified for use with FLAMMABLEAESTHETIC MIXTURE WITH AIR complied with G.4and G.5

N/A

G.2.5 ME EQUIPMENT or parts thereof for use withFLAMMABLE AESTHETIC MIXTURE WITH OXYGEN ORNITROUS OXIDE comply with G.4 and G.6

N/A

ME EQUIPMENT in G.2.4 to G.2.5 met appropriatetests of G.3-G.5 conducted after tests of 11.6.6and 11.6.7

N/A

G.3 Marking, ACCOMPANYING DOCUMENTS N/A

G.3.1 CATEGORY APG ME EQUIPMENT prominentlymarked “APG” (symbol 23 in Table D.1)..............:

See copies of Marking Labels N/A

Length of green-coloured band is 4 cm, andsize of marking is as large as possible forparticular case

N/A

When above marking not possible, relevantinformation included in instructions for use.... :

N/A

Marking complied with tests and criteria of7.1.2 and 7.1.3

N/A


EN 60601-1


G.3.2 CATEGORY AP ME EQUIPMENT prominently marked,with a green-coloured circle “AP” (symbol 22 inTable D.1)....................................................................:

See copies of MarkingLabels

N/A

Marking is as large as possible for theparticular case

N/A

When above marking not possible, the relevantinformation included in instructions for use.... :

N/A

Marking complied with tests and criteria of7.1.2 and 7.1.3

N/A

G.3.3 The marking placed on major part of MEEQUIPMENT for CATEGORY AP or APG parts

N/A

G.3.4 ACCOMPANYING DOCUMENTS contain an indicationenabling the RESPONSIBLE ORGANIZATION todistinguish between CATEGORY AP and APG parts

N/A

G.3.5 Marking clearly indicates which parts areCATEGORY AP or APG when only certain MEEQUIPMENT parts are CATEGORY AP or APG

N/A

G.4 Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT N/A

G.4.1 a) CREEPAGE and CLEARANCES are according toTable 12 for one MEANS OF PATIENT PROTECTION

N/A

b) Connections protected against accidentaldisconnection

N/A

c) CATEGORY AP and APG not provided with aDETACHABLE POWER SUPPLY CORD,

N/A

G.4.2 Construction details N/A

a) Opening of an ENCLOSURE protecting againstpenetration of gases or vapours into MEEQUIPMENT or its parts possible only with a TOOL

N/A

b) ENCLOSURE complies with..................................: See appended Table 8.10 N/A

– no openings on top covers of ENCLOSURE, N/A

– openings in side-covers preventedpenetration of a solid cylindrical test rod

N/A

– openings in base plates preventedpenetration of a solid cylindrical test

N/A

c) Short circuiting conductor(s) to a conductivepart (when no explosive gasses) did not resultin loss of integrity of the part, an unacceptabletemperature, or any HAZARDOUS SITUATION

N/A

G.4.3 a) Electrostatic charges prevented on CATEGORYAP and APG ME EQUIPMENT by a combination ofappropriate measures

N/A

– Use of antistatic materials with a limitedelectrical resistance.................................................:



EN 60601-1


– Provision of electrically conductive pathsfrom ME EQUIPMENT or its parts to a conductivefloor, protective earth or potential equalizationsystem, or via wheels to an antistatic floor

N/A

b) Electrical resistance limits of aesthetictubing, mattresses/ pads, castor tires & otherantistatic material comply with ISO 2882...........:

N/A

G.4.4 Corona cannot be produced by components orparts of ME EQUIPMENT operating at more than2000 V a.c. or 2400 V d.c. and not included inENCLOSURES complying with G.5.4 or G.5.5

N/A

G.5 Requirements and tests for CATEGORY AP ME EQUIPMENT, parts and components N/A

G.5.1 ME EQUIPMENT, its parts or components do notignite FLAMMABLE AESTHETIC MIXTURES WITH AIRunder NORMAL USE and CONDITIONS based oncompliance with G.5.2 to G.5.5

N/A

Alternatively, ME EQUIPMENT, its parts, andcomponents complied with requirements of IEC60079-0 for pressurized ENCLOSURES (IEC 60079-2); for sand-filled ENCLOSURES, IEC 60079-5; orfor oil immersed equipment, IEC 60079-6; andwith this standard excluding G.5.2 to G.5.5...... :

N/A

G.5.2 Temperature limits................................................... : See appended Tables 11.1.1and 11.2.2.1

N/A

G.5.3 ME EQUIPMENT, its parts, and componentsproducing sparks in NORMAL USE and CONDITIONcomplied with temperature requirements ofG.5.2, and Umax and Imax occurring in theircircuits, and complied as follows:

N/A

Measured Umax ≤ UzR with IzR as in Fig. G.1....... : Umax = __VUzR = __VIzR = __A

N/A

Measured Umax ≤ Ucwith Cmax as in Fig. G.2 ....: Umax = __VUc = __VCmax = __F

N/A

Measured Imax ≤ IzR with UzR as in Fig G.1 ........ : Imax = __AIzR = __AUzR = __V

N/A

Measured Imax ≤ IzL with Lmax and a Umax ≤ 24 Vas in Fig G.3.............................................................. :

Imax = __AIzL = __ALmax = __mH

N/A

– Combinations of currents and correspondingvoltages within the limitations IzR.UzR ≤ 50 Wextrapolated from Fig G.1

N/A

No extrapolation made for voltages above 42 V N/A

– Combinations of capacitances andcorresponding voltages within limitations ofC/2U2 1.2 mJ extrapolated from Fig G.2

N/A


EN 60601-1


No extrapolation made for voltages above 242V N/A

Umax determined using actual resistance R N/A

– Combinations of currents and correspondinginductances within limitations L/2I2 0.3 mJextrapolated from Fig G.3

N/A

No extrapolation made for inductances largerthan 900 mH

N/A

– Umaxwas the highest supply voltage occurringin circuit under investigation with sparkingcontact open

N/A

– Imax was the highest current flowing in circuitunder investigation with sparking contactclosed

N/A

– Cmax and Lmax taken as values occurring at thecomponent under investigation producingsparks

N/A

– Peak value considered when a.c. supplied N/A

– An equivalent circuit calculated to determineequivalent max capacitance, inductance, andequivalent Umax and Imax, either as d.c. or a.c.peak values in case of a complicated circuit....:

N/A

Temperature measurements made according to11.1, and Umax, Imax, R, Lmax , and Cmaxdetermined with application of Figs G.1-G.3... :


Alternatively, compliance was verified byexamination of design data...................................:

N/A

G.5.4 External ventilation with internal overpressure N/A

ME EQUIPMENT, its parts, and componentsenclosed in an ENCLOSURE with externalventilation by means of internal overpressurecomplied with the following requirements:

N/A

a) FLAMMABLE AESTHETIC MIXTURES WITH AIR tremoved by ventilation before EQUIPMENTenergized,

N/A

b) Overpressure inside ENCLOSURE was 75 Pa,min., in NORMAL CONDITION (Pa)............................. :

N/A

Overpressure maintained at the site of potentialignition

N/A

ME EQUIPMENT could be energized only after therequired minimum overpressure was presentlong enough to ventilate the ENCLOSURE

N/A

ME EQUIPMENT energized at will or repeatedlywhen overpressure was continuously present

N/A


EN 60601-1


c) Ignition sources de-energized automaticallywhen during operation overpressure droppedbelow 50 Pa (Pa)...................................................... :

N/A

d) External surface of ENCLOSURE did notexceed 150 °C in 25 °C........................................... :

N/A

G.5.5 ENCLOSURES with restricted breathing N/A

ME EQUIPMENT, its parts, and componentsenclosed in an ENCLOSURE with restrictedbreathing complied with the following:

N/A

a) A FLAMMABLE AESTHETIC MIXTURE WITH AIR didnot form inside ENCLOSURE with restrictedbreathing

N/A

b) Gasket or sealing material used to maintaintightness complied with aging test B-b of IEC60068-2-2, Clause 15, at 70 °C ± 2 °C and 96 h. :


c) Gas-tightness of ENCLOSURE containing inletsfor flexible cords maintained

N/A

Cords are fitted with adequate anchorages tolimit stresses as determined by test

N/A

Overpressure not reduced below 200 Pa N/A

Tests waived when examination of ENCLOSUREindicated it is completely sealed or gas-tightwithout a doubt (100 % degree of certainty)

N/A

Operating temperature of external surface ofENCLOSURE was 150 °C in 25 °C (°C)................ :

N/A

Steady state operating temperature ofENCLOSURE also measured (°C)............................ :

N/A

G.6 CATEGORY APG ME EQUIPMENT, parts and components thereof N/A

G.6.1 ME EQUIPMENT, its parts, and components didnot ignite FLAMMABLE AESTHETIC MIXTURE WITHOXYGEN OR NITROUS OXIDE under NORMAL USE andSINGLE FAULT CONDITION

N/A

ME EQUIPMENT, its parts, and components notcomplying with G.6.3 subjected to a CONTINUOUSOPERATION test

N/A

G.6.2 Parts and components of CATEGORY APG MEEQUIPMENT operating in a FLAMMABLE AESTHETICMIXTURE WITH OXYGEN OR NITROUS OXIDE suppliedfrom a source isolated from earth by insulationequal to one MEANS OF PATIENT PROTECTION andfrom electrical parts by insulation twice theMEANS OF PATIENT PROTECTION.................................:

N/A

G.6.3 Test of G.6.1 waived when the followingrequirements were met in NORMAL USE andunder NORMAL and SINGLE FAULT CONDITIONS.......:

N/A


EN 60601-1


a) no sparks produced and temperatures didnot exceed 90 °C, or

See Tables 11.1.1, 11.2.2.1and 13.2

N/A

b) a temperature limit of 90 °C not exceeded,sparks produced in NORMAL USE, and SINGLEFAULT CONDITIONS, except Umax and Imaxoccurring in their circuits complied withrequirements, taking Cmax and Lmax intoconsideration:

See Tables 11.1.1 and 13.2 N/A

Measured Umax ≤ UzR with IzR as in Fig. G.4 ..... : Umax = __VUzR = __VIzR = __A

N/A

Measured Umax ≤ UzCwith Cmax as in Fig. G.5.... : Umax = __VUc = __VCmax = __F

N/A

Measured Imax ≤ IzR with UzR as in Fig G.4 ........ : Imax = __AIzR = __AUzR = __V

N/A

Measured Imax ≤ IzL with Lmax and a Umax ≤ 24 Vas in Fig G.6 ............................................................ :

Imax = __AIzL = __ALmax = __mH

N/A

– Extrapolation from Figs G.4, G.5, and G.6 waslimited to areas indicated

N/A

– Umax was the highest no-load voltageoccurring in the circuit under investigation,taking into consideration mains voltagevariations as in Cl. 4.10

N/A

– Imax was the highest current flowing in thecircuit under investigation, considering MAINSVOLTAGE variations as in Cl. 4.10

N/A

– Cmax and Lmax are values occurring in relevantcircuit

N/A

– Umax additionally determined with actualresistance R when equivalent resistance R inFig G.5 was less than 8000

N/A

– Peak value considered when a.c. supplied N/A

– An equivalent circuit calculated to determinemax capacitance, inductance, and Umax and Imax,either as d.c. or a.c. peak values in case of acomplicated circuit ................................................ :

N/A

– When energy produced in an inductance orcapacitance in a circuit is limited by voltage orcurrent-limiting devices, two independentcomponents applied, to obtain the requiredlimitation even when a first fault (short or opencircuit) in one of these components

N/A

- requirement not applied to transformerscomplying with this standard

N/A


EN 60601-1


- requirement not applied to wire-woundcurrent-limiting resistors provided with aprotection against unwinding of the wire incase of rupture

N/A

Compliance verified by examination ofCATEGORY APG ME EQUIPMENT, parts, andcomponents , or

N/A

Temperature measurements made inaccordance with 11.1..............................................:

See Table 11.1.1 N/A

- or Umax, Imax, R, Lmax and Cmax determinedtogether with application of Figs G.4-G.6......... :

Umax = __VImax = __AR = __Lmax = __mHCmax = __F

N/A

Alternatively, compliance verified bycomparison with design data............................... :

N/A

G.6.4 ME EQUIPMENT, its parts, and componentsheating a FLAMMABLE AESTHETIC MIXTURE WITHOXYGEN OR NITROUS OXIDE provided with a non-SELF-RESETTING THERMAL CUT-OUT and compliedwith 15.4.2.1................................................................ :


Current-carrying part of heating element is notin direct contact with FLAMMABLE AESTHETICMIXTURE WITH OXYGEN OR NITROUS OXIDE

N/A

G.7 Test apparatus for flammable mixturesaccording to this Clause and Fig G.7

N/A

ANNEX L INSULATED WINDING WIRES FOR USE WITHOUT INTERLEAVEDINSULATION

N/A

L.1 BASIC, SUPPLEMENTARY, DOUBLE, and REINFORCEDINSULATION in wound components withoutinterleaved insulation complied with this Annex

N/A

L.2 Wire construction N/A

Overlap of layers when wire is insulated withtwo or more spirally wrapped layers of tape isadequate to ensure continued overlap duringmanufacture of wound component

N/A

Layers of spirally wrapped wire insulation aresufficiently secured to maintain the overlap

N/A

L.3 Type Test N/A

The wire subjected to tests of L.3.1 to L.3.4 at atemperature and a relative humidity specified

N/A

Temperature (°C)..................................................... : —

Humidity (%)............................................................. : —

L.3.1 Dielectric strength N/A


EN 60601-1


Dielectric strength test of Clause 8.8.3 for theappropriate type and number of MOP(s)conducted with no breakdown:

N/A

– 3000 V for BASIC and SUPPLEMENTARYINSULATION (V)............................................................:

N/A

– 6000 V for REINFORCED INSULATION (V).............. : N/A

L.3.2 Flexibility and adherence N/A

Sample subjected to flexibility and adherence N/A

Sample examined per IEC 60851-3: 1997, cl.5.1.1.4, followed by dielectric test of cl. 8.8.3,with no breakdown

N/A

Test voltage was at least the voltage in Tables6 and 7 but not less than the following:

N/A


N/A


Tension applied to wire during winding onmandrel calculated from the wire diameterequivalent to 118 MPa ± 11.8 MPa .....................:

N/A

L.3.3 Heat Shock N/A

Sample subjected to heat shock test 9 of IEC60851-6:1996, followed by dielectric strengthtest of clause 8.8.3

N/A

Test voltage was at least the voltage in Tables6 and 7, but not less than the following:

N/A


N/A


Oven temperature based on Table L.2 (C)...... : —

Mandrel diameter and tension applied as inclause L.3.2, (MPa; N/mm2)................................... :

N/A

Dielectric strength test conducted at roomtemperature after removal from the oven

N/A

L.3.4 Retention of electric strength after bending N/A

Five samples prepared as in L.3.2 subjected todielectric strength and bending tests

N/A

Test voltage was at least the voltage in Tables6 and 7, but not less than the following:

N/A


N/A


Test voltage applied between the shot andconductor

N/A


EN 60601-1


Mandrel diameter and tension applied as inL.3.2, (MPa; N/mm2).................................................:

N/A

L.4 Tests during manufacture N/A

L.4.1 Production line dielectric strength tests doneby the manufacture per L.4.2 and L.4.3............. :

See attached manufacturer’sroutine testing verification

N/A

L.4.2 Test voltage for routine testing (100 % testing)is at least the voltage in Tables 6 and 7 but notless than the following:

N/A

– 1500 V r.m.s. or 2100 V peak for BASIC andSUPPLEMENTARY INSULATION (V)...............................:

See manufacturer’s routinetesting verification

N/A

– 3000 V r.m.s. or 4200 V peak for REINFORCEDINSULATION (V)............................................................ :


N/A

L.4.3 Sampling tests conducted using twisted pairsamples (IEC 60851-5:1996, clause 4.4.1)......... :


N/A

Minimum breakdown test voltage at least twicethe voltage in Tables 6 and 7 but not less than:

N/A

– 3000 V r.m.s. or 4200 V peak for BASIC andSUPPLEMENTARY INSULATION......................................:


N/A

– 6000 V r.m.s. or 8400 V peak for REINFORCEDINSULATION....................................................................:


N/A


EN 60601-1


4.2.2 RM RESULTS TABLE: General requirements for RISK MANAGEMENT N/A

Clauseof ISO14971

Document Ref. in RMF (Document No.paragraph/clause, version) Result - Remarks VerdictGeneral process Particular Medical Device

3.1 — Risk Management Process (excludingproduction and post-production)

3.2 — Adequate Resources3.2 — Assignment of qualified personnel3.2 — Policy for determining criteria for risk

acceptability3.3 — Qualification of personnel3.4a —

3.4b —

3.4c —

3.4d —

3.4e —

3.5 —

4.1 —

4.2 —

4.3 —

4.4 —

5 —

6.2 —

6.3 —

6.4 —

6.5 —

6.6a —

6.6b —

6.7 —

7 —

8 —

Supplementary Information:Document Ref should be with regards to the policy/procedure documents and documents containingdevice specific output.


EN 60601-1


4.3 TABLE: ESSENTIAL PERFORMANCE N/A

List of ESSENTIALPERFORMANCE functions

MANUFACTURER’S document numberreference or reference from this standardor collateral or particular standard(s)

Remarks

Supplementary Information:ESSENTIAL PERFORMANCE is performance, the absence or degradation of which, would result in anunacceptable risk.

4.11 TABLE: Power Input N/A

Operating Conditions / Ratings Voltage(V)

Frequency(Hz)

Current(A)

Power(W or VA)

Power factor(cos φ)


5.9.2 TABLE: Determination of ACCESSIBLE parts P

Location Determination method (NOTE1) CommentsPower button /measurement button

visual -

Supplementary information:1)NOTE: The determination methods are: visual; rigid test finger; jointed test finger; test hook.


EN 60601-1


7.1.2 TABLE: Legibility of Marking PMarkings tested Ambient Illuminance (lx) Remarks

Outside Markings (Clause 7.2).................. : Polyester label P

Inside Markings (Clause 7.3)......................: Lnk, Paint P

Controls & Instruments (Clause 7.4)....... : Print, Silk print P

Safety Signs (Clause 7.5)............................ : Marking Label on NIBP cuff P

Symbols (Clause 7.6)................................... : No Warning Label N/A

Supplementary information:Observer, with a visual acuity of 0 on the log Minimum Angle of Resolution (log MAR) scale or 6/6 (20/20) and is able toread N6 of the Jaeger test card in normal room lighting condition (~500lx), reads marking at ambient illuminance leastfavourable level in the range of 100 lx to 1,500 lx. The ME EQUIPMENT or its part was positioned so that the viewpoint wasthe intended position of the OPERATOR or if not defined at any point within the base of a cone subtended by an angle of30° to the axis normal to the centre of the plane of the marking and at a distance of 1 m.

7.1.3 TABLE: Durability of marking testCharacteristics of the Marking Label tested: Remarks

Material of Marking Label ......................................... : Polyester label P

Ink/other printing material or process.....................: Lnk, Paint P

Material (composition) of Warning Label ..............: Print, Silk print P

Ink/other printing material or process.....................: Marking Label on NIBP cuff P

Other................................................................................: No Warning Label N/A

Marking Label Tested: Remarks

first for 15 s with a cloth rag soaked with distilled water P

then for 15 s with a cloth rag soaked with ethanol 96% P

then for 15 s with a cloth rag soaked with isopropyl alcohol P

Supplementary information:Marking rubbed by hand, first for 15 s with a cloth rag soaked with distilled water, then for 15 s with a clothrag soaked with ethanol 96%, and then for 15 s with a cloth rag soaked with isopropyl alcohol.


EN 60601-1


8.4.2 TABLE: TABLE: Working Voltage / Power Measurement N/A

Test supply voltage/frequency (V/Hz)1).................................................................... :

LocationFrom/To

Measured valuesRemarksVrms Vpk or

VdcPeak-to-

peak ripple2)PowerW/VA

Energy(J)

Supplementary Information:1)The input supply voltage to the ME EQUIPMENT was the RATED voltage or the voltage within the RATED voltage rangewhich results in the highest measured value. See clause 8.5.4.2). If the d.c peak-to-peak ripple >10%, waveform considered as a.c. See clause 8.4.2.2

8.4.3 TABLE: ME EQUIPMENT for connection to a power source by a plug- measurement of voltage or calculation of stored charge 1 s afterdisconnection of plug from mains supply

N/A

Maximum allowable voltage (V).................................................................................................. : 60

Voltage measured (V)

Voltage Measured Between: 1 2 3 4 5 6 7 8 9 10

Plug pins 1 and 2

Plug pin 1 and plug earth pin


Plug pin 1 and enclosure


Maximum allowable stored charge when measured voltage exceeded 60 v (c)........ : 45

Calculated stored charge (c)

Voltage Measured Between: 1 2 3 4 5 6 7 8 9 10

Plug pins 1 and 2





Supplementary information:


EN 60601-1


8.4.4 TABLE: Internal capacitive circuits – measurement of residual voltage orcalculation of the stored charge in capacitive circuits (i.e., accessiblecapacitors or circuit parts) after de-energizing ME EQUIPMENT

N/A

Maximum allowable residual voltage (V)..................................................................: 60 V

Maximum allowable stored charge when residual voltage exceeded 60 V......: 45 C

Description of the capacitive circuit(i.e., accessible capacitor or circuit

parts)

Measured residualvoltage (V)

Calculated storedcharge (C) Remarks


8.5.5.1a TABLE: defibrillation-proof applied parts – measurement of hazardouselectrical energies

N/A

TestCondition:Figs. 9 & 10

Measurementmade on

accessible part

Applied part withtest voltage

Test voltagepolarity

Measuredvoltage betweenY1 and Y2 (mV)

Remarks


8.5.5.1b TABLE: defibrillation-proof applied parts – verification of recovery time N/A

Applied part with testvoltage

Test voltagepolarity

Recovery time fromdocuments (s)

Measuredrecovery time (s) Remarks



EN 60601-1


8.5.5.2 TABLE: DEFIBRILLATION-PROOF APPLIED PARTS or PATIENT CONNECTIONS ofDEFIBRILLATION-PROOF APPLIED PARTS - Energy reduction test –measurement ofEnergy delivered to a 100 load

N/A

Test Voltage applied to Measured EnergyE1 (mJ)

Measured EnergyE2 (mJ)

Energy E1as % of E2 (%)

PATIENT CONNECTION 1 or APPLIED PART withPATIENT CONNECTIONS 2, 3, and 4 of the sameAPPLIED PART connected to earth




Supplementary information: For compliance: E1 must at least 90% of E2E1= Measured energy delivered to 100 with ME Equipment connected;E2= Measured energy delivered to 100 without ME equipment connected.

8.6.4 TABLE: Impedance and current-carrying capability of PROTECTIVE EARTHCONNECTIONS

N/A

Type of ME EQUIPMENT & impedancemeasured between parts

Test current(A)

/Duration (s)

Voltage dropmeasuredbetweenparts (V)

Maximumcalculatedimpedance

(m)

Maximumallowableimpedance

(m)

Supplementary information:PERMANENTLY INSTALLED ME EQUIPMENT, impedance between PROTECTIVE EARTH TERMINAL and a PROTECTIVELY EARTHED part - Limit 100mME EQUIPMENT with an APPLIANCE INLET, impedance between earth pin in the APPLIANCE INLET and a PROTECTIVELY EARTHED part -Limit 100 mME EQUIPMENT with an APPLIANCE INLET, impedance between earth pin in the protective earth pin on the DETACHABLE POWERSUPPLY CORD and a PROTECTIVELY EARTHED part - Limit 200 mME EQUIPMENT with a non-DETACHABLE POWER SUPPLY CORD, impedance between the protective earth pin in the MAINS PLUG and aPROTECTIVELY EARTHED part - Limit 200 m


EN 60601-1


8.7 TABLE: leakage current P

Type of leakage current and testcondition (including single faults)

Supplyvoltage(V)

Supplyfrequency

(Hz)

Measuredmax. value

(µA)Remarks

Fig. 13 - Earth Leakage (ER) — — — Maximum allowed values:5 mA NC; 10 mA SFC

- - - - -

- - - - -

- - - - -

- - - - -

Fig. 14 - Touch Current (TC) — — — Maximum allowed values:100 µA NC; 500 µA SFC

- - - - -

- - - - -

- - - - -

- - - - -

Fig. 15 - Patient Leakage Current (P) — — —

Maximum allowed values:Type B or BF AP: 10 µA NC; 50 µASFC (d.c. current);100 µA NC; 500 µA SFC (a.c.)Type CF AP: 10 µA NC; 50 µASFC (d.c. or a.c. current)

From patient connection to earth 3Vd.c - 0.005 SFC

Fig. 16 - Patient leakage current withmains on the F-type applied parts (PM) — — —

Maximum allowed values:Type B: N/AType BF AP: 5000 µAType CF AP: 50 µA

- - - - -

- - - - -

- - - - -

- - - - -

Fig. 17 - Patient leakage current withexternal voltage on Signal Input/Outputpart (SIP/SOP)

— — —

Maximum allowed values:Type B or BF AP: 10 µA NC; 50 µASFC(d.c. current);100 µA NC; 500 µA SFC (a.c.) ;Type CF AP: 10 µA NC; 50 µASFC (d.c. or a.c. current)

- - - - -

- - - -

- - - - -

- - - - -

- - - - -


EN 60601-1



Supplyvoltage(V)

Supplyfrequency

(Hz)

Measuredmax. value

(µA)Remarks

Fig. 18 - Patient leakage current withexternal voltage on metal AccessiblePart that is not Protectively Earthed

— — —Maximum allowed values:Type B or BF AP: 500 µAType CF: N/A

- - - - -

- - - - -

- - - - -

- - - - -

Fig. 19 – Patient Auxiliary Current — — —

Maximum allowed values:Type B or BF AP: 10 µA NC; 50 µASFC (d.c. current);100 µA NC; 500 µA SFC (a.c.) ;Type CF AP: 10 µA NC;50 µA SFC(d.c. or a.c. current)

- - - - -

- - - - -

- - - - -

- - - - -

Fig. 15 and 20 – Total Patient LeakageCurrent with all AP of same typeconnected together

— — —

Maximum allowed values:Type B or BF AP: 50 µA NC;100µA SFC (d.c. current);500 µA NC; 1000 µA SFC (a.c.);Type CF AP: 50 µA NC; 100 µASFC (d.c. or a.c. current)

- - - - -

- - - - -

- - - - -

- - - - -

Fig. 17 and 20 – Total Patient LeakageCurrent with all AP of same typeconnected together with externalvoltage on SIP/SOP

— — —

Maximum allowed values:Type B or BF AP: 50 µA NC;100µA SFC (d.c. current);500 µA NC;1000 µA SFC (a.c.);Type CF AP: 50 µA NC; 100 µASFC (d.c. or a.c. current)

- - - - -

- - - - -

- - - - -

- - - - -Fig. 16 and 20 – Total Patient LeakageCurrent with all AP of same typeconnected together with externalvoltage on F-type AP

— — —Maximum allowed values:Type B: NAType BF: 5000 µAType CF: 100 µA

- - - - -

- - - - -


EN 60601-1



Supplyvoltage(V)

Supplyfrequency

(Hz)

Measuredmax. value

(µA)Remarks

- - - - -

- - - - -

- - - - -Fig. 18 and 20 – Total Patient LeakageCurrent with all AP of same type connectedtogether with external voltage on metalAccessible Part not Protectively Earthed

— — —Maximum allowed values:Type B & BF: 1000 µAType CF: N/A

- - - - -

- - - - -

- - - - -

- - - - -

- - - - -Function Earth Conductor LeakageCurrent (FECLC) — — — Maximum allowed values:

5 mA NC; 10 mA SFC

- - - - -

- - - - -

- - - - -

- - - - -

- - - - -

- - - - -

Supplementary information:Note 1: For EARTH LEAKAGE CURRENT see 8.7.3 d) and 8.7.4.5;Note 2: For TOUCH CURRENT see 8.7.3 c) and 8.7.4.6;Note 3: For PATIENT LEAKAGE CURRENT SEE 8.7.3.b) and 8.7.4.7Note 4: Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS of the same type.See 8.7.4.7 h). The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values.Note 5: In addition to conditions indicated in the Table, tests conducted at operating temperature and after humiditypreconditioning of 5.7, EQUIPMENT energized in stand-by condition and fully operating, max rated supply frequency, at 110 %of the max RATED MAINS VOLTAGE, and after relevant tests of Clause 11.6 (i.e., overflow, spillage, leakage, ingress of waterand particulate matter, cleaning & disinfection, & sterilization).ER - Earth leakage currentTC – Touch currentP - Patient leakage currentPA – Patient auxiliary currentTP – Total Patient currentPM - Patient leakage current with mains on the applied partsMD - Measuring device

A - After humidity conditioningB - Before humidity conditioning1 - Switch closed or set to normal polarity0 - Switch open or set to reversed polarityNC - Normal conditionSFC - Single fault condition


EN 60601-1


8.8.3 TABLE: Dielectric strength test of solid insulating materials with safetyfunction – MEANS OF OPERATOR PROTECTION (MOOP) / MEANS OF PATIENTPROTECTION (MOPP)

P

Insulation under test(area from insulation

diagram)

Insulation Type(1 or 2

MOOP/MOPP)

Reference VoltageA.C. test

voltages in Vr.m.s1)

Dielectricbreakdown

after 1 minuteYes/No2)

PEAK WORKINGVOLTAGE (U)

V peak

PEAKWORKING

VOLTAGE (U)V d.c.

Double insulation (A) 1 -- 3 500 No

Double insulation (B) 2 -- 3 500 No

Supplementary information:1 Alternatively, per the Table (i.e., __dc), a d.c. test voltage equal to the peak value of the a.c. test voltage used.2 A) Immediately after humidity treatment of 5.7, ME EQUIPMENT de-energized, B) after required sterilization PROCEDURE,ME EQUIPMENT de-energized, C) after reaching steady state operating temperature as during heating test of 11.1.1, and D)after relevant tests of 11.6 (i.e., overflow, spillage, leakage, ingress of water, cleaning, disinfection, and sterilization).

8.8.4.1 TABLE: Resistance to heat - Ball pressure test of thermoplastic parts PAllowed impression diameter (mm) .................. : 2 mm

Force (N).................................................................... : 20

Part/material Testtemperature (C)

Impressiondiameter (mm)

Enclosure 125 0.68

PCB 125 0.92Insulating material supporting un-insulated Mains Parts 75 0.42



EN 60601-1


8.9.2 TABLE: Short circuiting of each single one of the CREEPAGE DISTANCES and AIRCLEARANCES for insulation in the MAINS PART between parts of oppositepolarity in lieu of complying with the required measurements in 8.9.4

N/A

Specific areas of circuits short-circuited and test conditions

Test in lieu ofCREEPAGE

DISTANCE or AIRCLEARANCE1)

HAZARDOUS SITUATIONobserved (i.e., fire hazard,shock hazard, explosion,discharge of parts, etc.)?

Yes/No

Remarks

Supplementary information:1)Note: AC - AIR CLEARANCE CD - CREEPAGE DISTANCE

8.9.3.2 Table: Thermal cycling tests on one sample of insulating compound formingsolid insulation between conductive parts

N/A

Part Test

8.9.3.4 - Test duration andtemperature for 10 cycles afterwhich the sample was subjectedto Humidity Preconditioning per

Cl. 5.7

Dielectric testvoltage

Dielectric strength testafter humidity

preconditioning per cl.5.7 except for 48 h only,Breakdown: Yes/No

Crack or voidsin the

insulatingcompound:Yes/No

68 h at T1 ± 2 °C = ___°C 1)

1 h at 25 °C ± 2 °C

2 h at 0 °C ± 2 °C

1 or more h at 25 °C ± 2 °C

Supplementary information:1) T1 = 10 °C above the maximum temperature of relevant part determined per 11.1.1, or 85 °C, the higher ofthe two. 10 °C not added to T1 when temperature measured by an embedded thermocouple. Used gradualtransition from one temperature to another.


EN 60601-1


8.9.3.3 Table: Thermal cycling tests on one sample of cemented joint with otherinsulating parts (see 8.9.3.3)

N/A

Parttested Sample Each test duration and temperature Dielectric test

voltageDielectric strength testBreakdown: Yes/No

1

10 Cycles conducted of thefollowing:

1 - 68 h at T1 ± 2 °C = ___°C1

2 - 1 h at 25 °C ± 2 °C

3 - 2 h at 0 °C ± 2 °C

4 - 1 or more h at 25 °C ± 2 °C

2 Humidity Conditioning per 5.7

3 Humidity Conditioning per 5.7

Supplementary information:1) T1 = 10 °C above the maximum temperature of relevant part determined per 11.1.1, or 85 °C, the higher ofthe two. 10 °C not added to T1 when temperature measured by an embedded thermocouple. Used gradualtransition from one temperature to another.


EN 60601-1


8.10 TABLE: List of critical components P

Component/Part No.

Manufacturer/Trademark

Type No./modelNo./

Technical data Standard No./,Edition

Mark(s) &Certificates ofconformity1)

PCB Various Various V-0, 130°C UL796 Test withappliance

Enclosure CHI MEICORPORATION

PA-757(+) HB,Min.1.5mm,80°C

UL94 Test withappliance andUL E56070

SiliconPressureSensor

ShenzhenPravance S&TDevelopmentCo.,Ltd

US9111 Max.10V, 125°C

-- --

Electronmagnetic value

Yuyao BozhongElectronicFactory

BZP06A Max.3.0V,0.36W

-- --

Supplementary information:1) Indicates a mark which assures the agreed level of surveillance. See Licenses and Certificates ofConformity for verification.

8.10 b TABLE: List of identified components with HIGH INTEGRITY CHARACTERISTICS N/A

Component/Part No.

Manufacturer/Trademark

Type No./modelNo./

Technical data Standard No./,Edition

Mark(s) &Certificates ofconformity1)

Supplementary information:1) Indicates a mark which assures the agreed level of surveillance. See Licenses and Certificates ofConformity for verification.


EN 60601-1


8.11.3.5 TABLE: Cord anchorages N/A

Cord under test Mass ofequipment (kg)

Pull (N) Torque Nm) Remarks


8.11.3.6 TABLE: Cord guard N/A

Cord under test Test mass Measured curvature Remarks


9.2.2.2 TABLE: Measurement of gap “a” according to Table 20 (ISO 13852: 1996) N/A

Part of body Allowable adultgap1), mm

Measured adultgap, mm

Allowable childrengap1), mm

Measured childrengap, mm

Body > 500 > 500Head > 300 or < 120 > 300 or < 60Leg > 180 > 180Foot > 120 or < 35 > 120 or < 25Toes > 50 > 50Arm > 120 > 120Hand, wrist, fist > 100 > 100Finger > 25 or < 8 > 25 or < 4Supplementary information: 1) In general, gaps for adults used, except when the device is specificallydesigned for use with children, values for children applied.

9.2.3.2 TABLE: Over-travel End Stop Test N/A

ME EQUIPMENT end stop Test Condition (cycles, load, speed) Remarks



EN 60601-1


9.4.2.1 TABLE: Instability—overbalance in transport position N/A

ME EQUIPMENTpreparation

Test Condition (transport position) Remarks


9.4.2.2 TABLE: Instability—overbalance excluding transport position N/A


Test Condition (excluding transportposition) Test either 5 ° incline and verify

Warning marking or 10 ° incline)

Remarks


9.4.2.3 TABLE: Instability—overbalance from horizontal and vertical forces N/A


Test Condition (force used, direction offorce, weight of equipment, location of

force)

Remarks


9.4.2.4.2 TABLE: Castors and wheels – Force for propulsion N/A


Test Condition (force location and height) Remarks



EN 60601-1


9.4.2.4.3 TABLE: Castors and wheels – Movement over a threshold N/A


Test Condition (speed of movement) Remarks


9.4.3.1 TABLE: Instability from unwanted lateral movement (including sliding) intransport position

N/A

ME EQUIPMENTPreparation

Test Condition (transport position,working load, locking device(s), caster

position)

Remarks


9.4.3.2 TABLE: Instability from unwanted lateral movement (including sliding)excluding transport position

N/A

ME EQUIPMENTPreparation

Test Condition (working load, lockingdevice(s), caster position, force, force

location, force direction)

Remarks


9.4.4 TABLE: Grips and other handling devices N/A

Clause and Name of Test Test Condition Remarks



EN 60601-1


9.7.5 TABLE: Pressure vessels N/AHydraulic,

Pneumatic orSuitable Media

and TestPressure

Vessel Burst PermanentDeformation Leaks Vessel fluid

substance Remarks


9.8.3.2 TABLE: PATIENT support/suspension system - Static forces N/AME EQUIPMENT part

or area Position Load Area Remarks


9.8.3.3 TABLE: Support/Suspension System – Dynamic forces due to loading frompersons

N/A

ME EQUIPMENTpart or area Position Safe Working

Load Area Remarks



EN 60601-1


10.1.1 TABLE: Measurement of X - radiation N/A

Maximum allowable radiation pA/kg ( μSv/h)(mR/h)

36 (5 Sv/h) (0.5 mR/h)

Surface area under testSurface no./ Description1)

Measured Radiation,pA/kg (μSv/h) (mR/h)

Remarks

1/ /2/ /3/ /4/ /5/ /6/ /7/ /8/ /9/ /10/ /

Supplementary information:1) Measurements made at 5 cm from any surface to which OPERATOR (other than SERVICE PERSONNEL) cangain access without a TOOL, is deliberately provided with means of access, or is instructed to enterregardless of whether or not a TOOL is needed to gain access


EN 60601-1


11.1.1 TABLE: Excessive temperatures in ME EQUIPMENT P

Model No....................................................... : HYCH002,HYCH003

Test ambient (C) ......................................: 26.5

Test supply voltage/frequency (V/Hz)4).. : 3.0Vdc

Model No.Thermo-coupleNo.

Thermocouple location3)Max allowable

temperature1) fromTable 22, 23 or 24 orRM file for AP5) (C)

Maxmeasured

temperature2),(C)

Remarks

HYCH002,

HYCH003

101 PCB 130 32.5

HYCH002,

HYCH003

102 Battery 60 29.6

HYCH002,

HYCH003

103 LCD 60 28.3

HYCH002,

HYCH003

104 Enclosure 60 28.6

HYCH002,

HYCH003

105 Enclosure for infrared sensor 60 28.5

HYCH002,

HYCH003

106 Button 55 28.0

Supplementary information:1) Maximum allowable temperature on surfaces of test corner is 90 C2) Max temperature determined in accordance with 11.1.3e)3) When thermocouples used to determine temperature of windings, limits of Table 22 reduced by 10 °C.4) Supply voltage:

- ME EQUIPMENT with heating elements - 110 % of the maximum RATED voltage;- Motor operated ME EQUIPMENT - least favourable voltage between 90 % of the minimum RATED and 110 %of

the maximum RATED voltage. ME EQUIPMENT operated under normal load and normal DUTY CYCLE.- Combined heating and motor operated and other ME EQUIPMENT - tested both at 110 % of the maximum

RATED voltage and at 90 % of the minimum RATED voltage.5) APPLIED PARTS intended to supply heat to a PATIENT - See RISK MANAGEMENT FILE containing temperatures and clinicaleffects. Also, see instructions for use.Information from Risk Management, as applicable:

11.1.3d TABLE: Temperature of windings by change-of-resistance method N/A

Temperature T of winding: t1 (°C) R1 () t2 (°C) R2 () T (C) AllowedTmax (C)

Insulation class


EN 60601-1




EN 60601-1


11.2.2.1 TABLE: Alternative method to 11.2.2.1 a) 5) to determine existence of anignition source

N/A

Areas where sparking might cause ignition: Remarks

1.

2.

3.

4.

5.

6.

Materials of the parts between which sparks could occur (Composition,Grade Designation, Manufacturer):

Remarks

1.

2.

3.

4.

5.

6.

Test parameters selected representing worst case conditions for MEEQUIPMENT:

Remarks

Oxygen concentration (%)..................:

Fuel.......................................................... :

Current (A)..............................................:

Voltage (V)..............................................:

Capacitance (F)...................................:

Inductance or resistance (h or )..... :

No. of trials (300 Min)...........................:

Sparks resulted in ignition (Yes/No) :

Supplementary information: Test procedure of 11.2.2.1 a) 5) & Figs 35-37 used for tests. For circuits not inFigs 35-37, test voltage or current set at 3 times the worst-case values with other parameters set at worst casevalues to determine if ignition can occur.Information from Risk Management, as applicable:


EN 60601-1


11.6.1 TABLE: overflow, spillage, leakage, ingress of water, cleaning, disinfection,sterilization, compatibility with substances

N/A

Clause / Test Name Test Condition Part under test Remarks


Information from Risk Management, as applicable:

13.1.2 TABLE: measurement of power or energy dissipation in parts & components towaive SINGLE FAULT CONDITIONS in 4.7, 8.1 b), 8.7.2, and 13.2.2 relative toemission of flames, molten metal, or ignitable substances

N/A

Power dissipated less than (W).................................. : 15

Energy dissipated less than (J).................................. : 900

Part or componenttested

Measured powerdissipated (W)

Calculated energydissipated (J)

SINGLE FAULT CONDITIONSwaived (Yes/No)

Remarks



EN 60601-1


13.2 TABLE: SINGLE FAULT CONDITIONS in accordance with 13.2.2 to 13.2.13, inclusive P

ClauseNo. Description of SINGLE FAULT CONDITION Results observed

HAZARDOUSSITUATION(Yes/No)

13.2.2 Electrical SINGLE FAULT CONDITIONS per Cl. 8.1: — —

According to the circuit structure of the Blood to 8.1 - N/A

13.2.3 Overheating of transformers per Clause 15.5: — —

No transformers - N/A

13.2.4 Failure of THERMOSTATS according to 13.2.13 &15.4.2, overloading - THERMOSTATS shortcircuited or interrupted, the less favourable ofthe two:

— —

No THERMOSTATS - N/A

13.2.5 Failure of temperature limiting devicesaccording to 13.2.13 & 15.4.2, overloading,THERMOSTATS short circuited or interrupted, theless favourable of the two:

— —

No THERMOSTATS N/A

13.2.6 Leakage of liquid - RISK MANAGEMENT FILEexamined to determine the appropriate testconditions (sealed rechargeable batteriesexempted)

— —

N/A

13.2.7 Impairment of cooling that could result in aHAZARD using test method of 11.1:

— —

Single ventilation fans locked consecutively N/A

Ventilation openings on top and sides impairedby covering openings on top of ENCLOSURE orpositioning of ME EQUIPMENT against walls

N/A

Simulated blocking of filters N/A

Flow of a cooling agent interrupted N/A

13.2.8 Locking of moving parts – Only one part lockedat a time – Also see 13.2.10 below:

— —

No moving parts provided - N/A


EN 60601-1


ClauseNo. Description of SINGLE FAULT CONDITION Results observed

HAZARDOUSSITUATION(Yes/No)

13.2.9 Interruption and short circuiting of motorcapacitors – Motor capacitors short & opencircuited 1) – Also see 13.10

— —

No motor V measured = N/A

V measured =

13.2.10 Additional test criteria for motor operated MEEQUIPMENT in 13.2.8 &13.2.9:

— —

For every test in SINGLE FAULT CONDITION of 13.2.8and 13.2.9, motor-operated EQUIPMENT staredfrom COLD CONDITION at RATED voltage or upperlimit of RATED voltage range for specified time:

N/A

Temperatures of windings determined at theend of specified test periods or at the instant ofoperation of fuses, THERMAL CUT-OUTS, motorprotective devices

N/A

Temperatures measured as specified in 11.1.3 d) N/A

Temperatures did not exceed limits of Table 26 N/A

13.2.11 Failures of components in ME EQUIPMENT used inconjunction with OXYGEN RICH ENVIRONMENTS:

— —

No conjunction with OXYGEN RICH - N/A

13.2.12 Failure of parts that might result in a MECHANICALHAZARD (See 9 & 15.3):

— —

No parts - N/A

Supplementary information:1) Test with short-circuited capacitor not performed when motor provided with a capacitor complying with IEC 60252-1 and the MEEQUIPMENT not intended for unattended use including automatic or remote control. See Attachment # and appended Table 8.10.

Information from Risk Management, as applicable:


EN 60601-1


15.3 TABLE: Mechanical Strength tests 1) P

Clause Name of Test Test conditions Observed results/Remarks15.3.2 Push Test Force = 250 N ± 10 N for 5 s P

15.3.3 Impact Test Steel ball (50 mm in dia., 500 g ± 25 g)falling from a 1.3 m

N/A

15.3.4.1 Drop Test (hand-held) Free fall height (m) = 1 P

15.3.4.2 Drop Test (portable) Drop height (cm) = N/A

15.3.5 Rough handling test Travel speed (m/s) = N/A

15.3.6 Mould Stress Relief 7 h in oven at temperature (°C) =70 P

Supplementary information: 1)As applicable, Push, Impact, Drop, Mould Stress Relief and Rough HandlingTests (delete not applicable rows or state N/A in Remarks field).

15.4.6 TABLE: actuating parts of controls of ME EQUIPMENT – torque & axial pull tests N/A

Rotating controlunder test

Gripping diameter“d” of controlknob (mm)1)

Torque fromTable 30 (Nm)

Axial forceapplied(N)

UnacceptableRISK occurred

Yes/No

Remarks

Supplementary information: 1)Gripping diameter (d) is the maximum width of a control knob regardless of itsshape (e.g. control knob with pointer)

15.5.1.2 TABLE: transformer short circuit test short-circuit applied at end of windingsor at the first point that could be short circuited under SINGLE FAULT CONDITION

N/A

Primary voltage (most adverse value from 90 % to 110 % of RATED voltage)(V)1)....: —

RATED input frequency (Hz)........................................................................................: —

Windingtested

Class ofinsulation(A, B, E, F,

or H)

Type ofprotective device(fuse, circuit

breaker) /Ratings

ProtectivedeviceoperatedYes/No

Time to THERMALSTABILITY (whenprotective device

did notoperate)(Min)

Maximumallowed

temp fromTable 31(ºC)

Maximumwindingtemp

measured(ºC)

Ambient(ºC)

Supplementary information:1)Loads on other windings between no load and their NORMAL USE load. Short-circuit applied at end ofwindings or at the first point that could be short circuited under SINGLE FAULT CONDITION.


EN 60601-1


15.5.1.3 TABLE: transformer overload test – conducted only when protective deviceunder short-circuit test operated

N/A

Primary voltage, most adverse value between 90 % to 110 % of RATED voltage (V)1)...... :

RATED input frequency (Hz)........................................................................................................... :

Test current just below minimum current that would activate protective device andachieve THERMAL STABILITY under method a) (A)....................................................................... :

Test current based on Table 32 when protective device that operated under method a)is external to transformer, and it was shunted (A)...................................................................:

Winding testedClass ofinsulation

(A, B, E, F, H)

Type of protective deviceused (fuse, circuitbreaker)/Ratings

Maximum allowedtemp fromTable 31 (ºC)

Maximumwinding tempmeasured (ºC)

Ambient(ºC)

Supplementary information:1)Loads on other windings between no load and their NORMAL USE load.Time durations: - IEC 60127-1 fuse: 30 min at current from Table 32.Non IEC 60127-1 fuse: 30 min at the current based on characteristics supplied by fuse manufacturer, specifically, 30 minclearing-time current. When no 30 min clearing-time current data available, test current from Table 32 used until THERMALSTABILITY achieved.- Other types of protective devices: until THERMAL STABILITY achieved at a current just below minimum current operating theprotective device in a). This portion concluded at specified time or when a second protective device opened.

15.5.2 TABLE: Transformer dielectric strength after humidity preconditioning of 5.7 N/A

TransformerModel/Type/ Part

No

Test voltage applied between Testvoltage,

(V)

Testfrequency

(Hz)

BreakdownYes/No

DeteriorationYes/No

Primary & secondary windings

Primary winding & frame

Secondary winding & frame

Supplementary information: Tests conducted under the conditions of 11.1, in ME EQUIPMENT or undersimulated conditions on the bench. See Clause 15.5.2 for test parameters & other details


EN 60601-1


16.6.1 TABLE: LEAKAGE CURRENTS in ME SYSTEM _ TOUCH CURRENT MEASUREMENTS N/ASpecific area where TOUCH

CURRENTmeasured (i.e., fromor between parts of ME SYSTEMwithin PATIENT ENVIRONMENT)

AllowableTOUCH CURRENTin NORMAL

CONDITION (A)

MeasuredTOUCH

CURRENT inNORMALCONDITION

(A)

Allowable TOUCH CURRENTin event of interruption of

PROTECTIVE EARTHCONDUCTOR, (A)

Measured TOUCHCURRENT in event ofinterruption of

PROTECTIVE EARTHCONDUCTOR, (A)

100 500

100 500

100 500

100 500

100 500


SP TABLE: Additional or special tests conducted N/A

Clause and Name of Test Test type and condition Observed results



EN 60601-1-11


4 GENERAL REQUIREMENTS P

4.1 Characteristics of SUPPLY MAINS specified in 4.10.2of Part 1 applied, except ME EQUIPMENT or MESYSTEMS intended for HOME HEALTHCAREENVIRONMENT complied with the following:

P

– SUPPLYMAINS in the HOME HEALTHCAREENVIRONMENT did not exceed 110 % or was notbelow 85 % of NOMINAL voltage between any of theconductors of the system or between any of theseconductors and earth (% V)......................................... :

—

– For ME EQUIPMENT OR ME SYSTEMS intended toactively keep alive or resuscitate a PATIENT, SUPPLYMAINS in the HOME HEALTHCARE ENVIRONMENT did notexceed 110 % or was not below 80 % of NOMINALvoltage between any of the conductors of thesystem or between any of these conductors andearth (% V.......................................................................:

—

- RATED range of NOMINAL voltage did include atleast 12.4 V to 15.1 V for operation from a 12 V dcsupply mains

N/A

- RATED range of NOMINAL voltage did include atleast 24.8 V to 30.3 V for operation from a 12 V dcsupply mains

N/A

The equipment maintained BASIC SAFETY andESSENTIAL PERFORMANCE during and following a 30 sdip to 10 V from a 12 V dc SUPPLY MAINS

N/A

The equipment maintained BASIC SAFETY andESSENTIAL PERFORMANCE during and following a 30 sdip to 20 V from a 24 V dc SUPPLY MAINS

N/A

4.2.2 Environmental conditions of transport and storage between uses, indicated ininstructions for use

P

ME EQUIPMENT, except STATIONARY EQUIPMENT, afterbeing removed from its protective packaging, andsubsequently between uses, operated within itsspecified NORMAL USE after transport or storage inthe specified environmental conditions

P

temperature range:-25 °C to + 5 °C N/A

temperature range:+5 °C to +35 °C at a non-condensing relative humidity up to 90 %

10°C~40°C, >85% P

temperature range: >35 °C to 70 °C at a watervapour pressure up to 50 hPa

N/A

For more restricted range of environmental transportand storage conditions between uses, theenvironmental conditions are specified

P

– Justified in the RISK MANAGEMENT FILE See RISK MANAGEMENT Table4.2.2

N/A

– Marked on the ME EQUIPMENT N/A


EN 60601-1-11


When not practicable, the more restricted range isdisclosed in the instructions for use

N/A

– Marked on the carrying case when the instructionsfor use indicate the ME EQUIPMENT is intended to betransported or stored in a carrying case betweenuses

N/A

Symbol 5.3.5 (ISO 7000-0534), 5.3.6 (ISO 7000-0533), or 5.3.7 (ISO 7000-0632) of ISO 15223-1:2012 used to mark temperature range

N/A

Symbol 5.3.8 (ISO 7000-2620) of ISO 15223-1:2012used to mark humidity range

N/A

Symbol 5.3.9 (ISO 7000-2621) of ISO 15223-1:2012used to mark atmospheric pressure range

N/A

Where ME EQUIPMENT used different marking forconditions of transport and storage between uses,continuous operating conditions and transientoperating conditions, markings accompanied bysupplementary markings except where therespective applicability was obvious

N/A

Environmental transport and storage test P

a) ME EQUIPMENT prepared for transportation orstorage according to instructions for use

P

b) ME EQUIPMENT exposed to its lowest specifiedenvironmental transport and storage conditions

(temperature °C) (°C)............................................ :

10 °C P

– For at least 16 h or, ensure ME EQUIPMENT reachedTHERMAL STABILITY for at least 2 h

P

c) Then ME EQUIPMENT exposed to 34 °C + 4 °Cand 90 % - 0% + 6% relative humidity until the testchamber reached equilibrium and held for at least 2hours. The transition from low to high temperaturewas made slowly enough to provide a non-condensing environment.

P

d) ME EQUIPMENT exposed to its highest specifiedenvironmental transport and storage conditions, notrequiring a water vapour pressure greater than 50

hPa (temperature °C ); (°C, ± %)...................... :

40 °C P

– For at least 16 h or, ensured ME EQUIPMENTreached THERMAL STABILITY for at least 2 h

P

e) At the end of this conditioning period, MEEQUIPMENT allowed to return and stabilize at theoperating conditions of NORMAL USE

P

f) ME EQUIPMENT evaluated to its specifications andensured it provides BASIC SAFETY and ESSENTIALPERFORMANCE

P

4.2.3.1 Environmental operating conditions - Continuous operating conditions N/A


EN 60601-1-11


Instructions for use indicated permissibleenvironmental operating conditions of the MEEQUIPMENT

N/A

ME EQUIPMENT complied with its specifications andall requirements of the standard when operated inNORMAL USE within temperature + 5 °C to +40 °C,

N/A

Relative humidity range of 15 % to 90%, non-condensing, but not requiring a water vapour partialpressure greater than 50 hPa; and

N/A

An atmospheric pressure range of 700 hPa to 1060hPa

N/A

For more restricted range of environmentaloperating conditions

N/A

- justified in the risk management file; See RISK MANAGEMENT Table4.2.3.1

N/A

-marked on the equipment; or were nor practical inthe instructions for use……………………………….:

N/A

– Marked on the carrying case when the instructionsfor use indicate the ME EQUIPMENT is intended to beoperated in a carrying case

N/A

Symbol 5.3.5 (ISO 7000-0534), 5.3.6 (ISO 7000-0533), or 5.3.7 (ISO 7000-0632) of ISO 15223-1:2012 used to mark temperature range

N/A

Symbol 5.3.8 (ISO 7000-2620) of ISO 15223-1:2012used to mark humidity range

N/A

Symbol 5.3.9 (ISO 7000-2621) of ISO 15223-1:2012used to mark atmospheric pressure range

N/A

Where ME EQUIPMENT used different marking forconditions of continuous operating conditions andtransient operating conditions, markingsaccompanied by supplementary markings

N/A

Environmental operating conditions test N/A

a) ME EQUIPMENT was set up for operation accordingto INTENDED USE

N/A

b) ME EQUIPMENT exposed to 20 °C + 4 °C for atleast 6 h or, ensured ME EQUIPMENT reachedTHERMAL STABILITY for at least 2 h, (h).........................:

N/A

c) ME EQUIPMENT evaluated to its specifications andensured it continued to provide BASIC SAFETY andESSENTIAL PERFORMANCE

N/A

d) ME EQUIPMENT evaluated to its specifications andensured it continued to provide BASIC SAFETY andESSENTIAL PERFORMANCE while at the lowestspecified atmospheric pressure.

N/A


EN 60601-1-11


e) ME EQUIPMENT evaluated to its specifications andensured it continued to provide BASIC SAFETY andESSENTIAL PERFORMANCE while at the highestspecified atmospheric pressure.

N/A

f) Pressure in chamber relieved N/A

g) ME EQUIPMENT cooled to its lowest specifiedenvironmental operating conditions

N/A

h) ME EQUIPMENT held at lowest specifiedenvironmental operating conditions for at least 6 hor, ensured the ME EQUIPMENT reached THERMALSTABILITY for at least 2 h ..............................................:

N/A

i) ME EQUIPMENT met its specifications and BASICSAFETY and ESSENTIAL PERFORMANCE

N/A

j) ME EQUIPMENT warmed to its highest specifiedcontinuous environmental operating conditions

N/A

k) ME EQUIPMENT held the conditions of j) for at least6 h or, ensured the ME EQUIPMENT reached THERMALSTABILITY for at least 2 h ..............................................:

N/A

l) ME EQUIPMENT met its specifications and BASICSAFETY and ESSENTIAL PERFORMANCE

N/A

4.2.3.2 Environmental shock to TRANSIT-OPERABLE EQUIPMENT N/A

TRANSIT-OPERABLE EQUIPMENT with a stated widerrange of continuous environmental operationconditions maintained BASIC SAFETY and ESSENTIALPERFORMANCE in the presence of condensation andthermal shock from rapid changes in environmentaltemperature and humidity during INTENDED USEwhen test in accordance with 4.2.3.2 a)-j).

N/A


EN 60601-1-11


5 GENERAL REQUIREMENTS FOR TESTING ME EQUIPMENT P

In addition to the requirements of 5.9.2.1 of with IEC 60601-1 standard, accessibilitydetermined as indicated below:

P

ACCESSIBLE parts of ME EQUIPMENT identified byinspection and, when necessary, by testing

P

When in doubt, an ACCESSIBLE PART of ME EQUIPMENTdetermined by a test with the small finger probe ofFig 1, applied in a bent or straight position as follows:

P

– for all positions of the ME EQUIPMENT operating inNORMAL USE

N/A

– after opening ACCESS COVERS and removal of parts,including lamps, fuses, and fuse holders when:

N/A

i) the ACCESS COVERS could be opened without theuse of a TOOL, or

N/A

ii) the instructions for use instructed a LAY OPERATORto open the relevant ACCESS COVER

N/A

6 CLASSIFICATION OF ME EQUIPMENT AND ME SYSTEMS P

ME EQUIPMENT intended for HOME HEALTHCAREENVIRONMENT classified as follows, except forPERMANENTLY INSTALLED EQUIPMENT and as requiredby Part 1, Sub-clause 6.2:

P

– CLASS II or INTERNALLY POWERED.............................. : 3.0V dc AAA batteries N/A

– Not provided with a FUNCTIONAL EARTH TERMINAL N/A

– When equipped with APPLIED PARTS, they are TYPEBF or CF........................................................................... :

Type BF P

7 ME EQUIPMENT IDENTIFICATION, MARKING AND DOCUMENTS P

7.1 USABILITY of identification, marking, andACCOMPANYING DOCUMENTS intended for LAYOPERATOR or LAY RESPONSIBLE ORGANIZATIONevaluated by an OPERATOR whose PROFILE includedminimum eight years of education

N/A

ME EQUIPMENT and ME SYSTEMS intended for HOMEHEALTHCARE ENVIRONMENT are simple to use and donot require referencing complex ACCOMPANYINGDOCUMENTS.................................................................... :

See USABILITY ENGINEERINGFILE

N/A

7.2 In addition to requirements of 7.2.9 of the generalstandard, the carrying case provided some or all ofthe ingress protection against water or particulatematter, The ENCLOSURE is marked with the safetysign ISO 7010-W001 and “keep dry” or ................... :

IP20 N/A

Symbol ISO 15223-1:2012, 5.3.4 (ISO 7000-0626) N/A

A carrying case marked with degree of protection P


EN 60601-1-11


Carrying case inspected, and tests and criteria of7.1.2 and 7.1.3 of Part 1 applied................................. :

See IEC 60601-1 Test report,Sub-clauses 7.1.2 and 7.1.3

P

7.3 ACCOMPANYING DOCUMENTS P

7.3.1 ACCOMPANYING DOCUMENTS indicate the LAYOPERATOR or LAY RESPONSIBLE ORGANIZATION shouldcontact the MANUFACTURER or MANUFACTURER'Srepresentative on the following issues:

P

– Assistance in setting up, using, or maintaining theME EQUIPMENT or ME SYSTEM when needed, or

P

– To report unexpected operation or events P

ACCOMPANYING DOCUMENTS include a postal addressand either a phone number or web address for theLAY OPERATOR or LAY RESPONSIBLE ORGANIZATION tocontact the MANUFACTURER or MANUFACTURER'Srepresentative

P

7.3.2 ACCOMPANYING DOCUMENTS include necessarydetails for healthcare professional to brief the LAYOPERATOR or LAY RESPONSIBLE ORGANIZATION on anyknown contraindication(s) to the use of MEEQUIPMENT or ME SYSTEM and any precautions to betaken, including the following:

N/A

– Precautions to be taken in the event of changes inthe performance of ME EQUIPMENT or ME SYSTEM

N/A

– Precautions to be taken regarding the exposure ofthe ME EQUIPMENT or ME SYSTEM to reasonablyforeseeable environmental conditions

N/A

– Adequate information regarding medicinalsubstances that ME EQUIPMENT is designed toadminister, including any limitations in the choice ofsubstances to be delivered as indicated below:

N/A

– Information on any medicinal substances orhuman blood derivatives incorporated into the MEEQUIPMENT or ACCESSORIES as an integral part; and

N/A

– The degree of accuracy claimed for ME EQUIPMENTwith a measuring FUNCTION

N/A

7.4 Instructions for use N/A

7.4.1 Nature of the HAZARD, likely consequences thatcould occur if the advice is not followed, andprecautions for reducing the RISK described ininstructions for use corresponding to each warningand safety sign.............................................................. :

See RISK MANAGEMENT Table7.4.1

N/A

The instructions for use address the following issues, as applicable: N/A

– Strangulation due to cables and hoses,particularly due to excessive length

N/A

– Inhalation or swallowing of small parts N/A


EN 60601-1-11


– Potential allergic reactions to accessible materialsused in the ME EQUIPMENT

N/A

– Contact injuries N/A

The instructions for use include warnings to theeffect that the following actions could be unsafe asapplicable:

N/A

– Use of ACCESSORIES, detachable parts, andmaterials not described in the instructions for use(see 7.9.2.14 of Part 1)

N/A

– Interconnection of this equipment to otherequipment not described in the instructions for use(see 16.2 c) indent 9) of Part 1)

N/A

– Modification of the equipment N/A

– Use of the ME EQUIPMENT outside its carrying casewhen some part of the protection required by thisstandard is provided by that carrying case (see8.3.1 and 10.1)

N/A

7.4.2 When BASIC SAFETY or ESSENTIAL PERFORMANCEdependents on the INTERNAL ELECTRICAL POWERSOURCE, the instructions for use describes thefollowing:

P

– Typical operation time or number of procedures... : P

– Typical service life of the INTERNAL ELECTRICALPOWER SOURCE; and..................................................... :

P

– Behaviour of ME EQUIPMENT while therechargeable INTERNAL ELECTRICAL POWER SOURCEis charging......................................................................:

N/A

7.4.3 Instructions for use for ME EQUIPMENT intended foruse by a LAY OPERATOR include easily understooddiagrams, illustrations, or photographs of the fullyassembled and ready-to-operate ME EQUIPMENTincluding all controls, visual INFORMATION SIGNALS,and indicators provided (see 7.1)

P

7.4.4 Additional requirements for ME EQUIPMENT start-up PROCEDURE: N/A

– Easily understood diagrams, illustrations, orphotographs showing proper connection of thePATIENT to the ME EQUIPMENT, ACCESSORIES andother equipment (see 7.1)

N/A

– the time from switching “ON” until the MEEQUIPMENT is ready for NORMAL USE, when itexceeds 15 s (see 15.4.4 of Part 1) (s)...................... :

N/A

-the time required for ME EQUIPMENT to warm fromthe minimum storage temperature between usesuntil it is ready for intended use; and ........................ :

N/A

-the time required for ME EQUIPMENT to cool from themaximum storage temperature between uses until itis ready for intended use; and ................................... :

N/A


EN 60601-1-11


7.4.5 Instructions for use for ME EQUIPMENT intended foruse by a LAY OPERATOR include a description ofgenerally known conditions in the HOME HEALTHCAREENVIRONMENT that can unacceptably affect the BASICSAFETY and ESSENTIAL PERFORMANCE of the MEEQUIPMENT

N/A

The steps that can be taken by the LAY OPERATOR toidentify and resolve the above conditions

N/A

At least the following issues are also included as applicable N/A

- The effects of lint, dust, light (including sunlight),etc.

N/A

- A list of known devices or other sources that canpotentially cause interference problems

N/A

- The effects of degraded sensors and electrodes,or loosened electrodes, that can degradeperformance or cause other problems

N/A

- The effects caused by pets, pests or children N/A

The instructions for use explain the meaning of theIP classification marked on the ME EQUIPMENT, andon any carrying case provided with the MEEQUIPMENT as applicable

See RISK MANAGEMENT Table7.4.5

N/A

7.4.6 Instructions for use include a troubleshooting guidefor use when there are indications of a MEEQUIPMENT malfunction during start-up or operation

N/A

Troubleshooting guide discloses the necessarysteps in the event of an TECHNICAl ALARM CONDITION

N/A

7.4.7 Instructions for use for ME EQUIPMENT, ME SYSTEMS,parts, and ACCESSORIES for other than single usethat can be contaminated by contact with PATIENT,body fluids, or expired gases, during INTENDED USE,indicate the following:

N/A

– Frequency of cleaning, cleaning and disinfection,or cleaning and sterilization, as appropriate, for MEEQUIPMENT, ME SYSTEMS, parts, and ACCESSORIESused on the same PATIENT including rinsingmethods, drying, handling, and storage betweenuses (see 8.1 and 8.2); and

N/A

– It is necessary to clean and disinfect, clean andsterilize the ME EQUIPMENT, ME SYSTEMS, parts, andACCESSORIES for multiple PATIENT use between useson different PATIENTS, including rinsing methods,drying, handling, and storage until re-use (see 8.1and 8.2), or

N/A

– ME EQUIPMENT, ME SYSTEMS and ACCESSORIESrequire professional hygienic maintenance prior tore-use and provide contact details for the source ofthese services (see 7.5.2)

N/A

7.4.8 Instructions for use include: N/A


EN 60601-1-11


– EXPECTED SERVICE LIFE of the ME EQUIPMENT ....... : N/A

– EXPECTED SERVICE LIFE of parts and ACCESSORIESshipped with the ME EQUIPMENT ................................. :

N/A

– SHELF LIFE of parts and ACCESSORIES shipped withME EQUIPMENT when SHELF LIFE is less than theEXPECTED SERVICE LIFE.................................................:

N/A

7.4.9 Instructions for use include: N/A

– A statement indicating the LAY RESPONSIBLEORGANIZATIONmust contact its local authorities todetermine the proper method of disposal ofpotentially bio hazardous parts and ACCESSORIES,as applicable

N/A

7.4.10 Instructions for use includes the recommendedplacement of the remote parts of the DISTRIBUTEDALARM SYSTEM, when applicable, to ensure theOPERATOR can be notified at all times by anappropriate element of DISTRIBUTED ALARM SYSTEMwithin its specified range

N/A

7.5 Technical description N/A

7.5.1 The technical description for PERMANENTLYINSTALLED CLASS I ME EQUIPMENT includes:

N/A

– A warning indicating the ME EQUIPMENTinstallation, including a correct PROTECTIVE EARTHCONNECTION, must only be carried out by qualifiedSERVICE PERSONNEL

N/A

– Specifications of the PERMANENTLY INSTALLEDPROTECTIVE EARTH CONDUCTOR

N/A

– A warning to verify the integrity of the externalprotective earthing system

N/A

– A warning to connect and verify that thePROTECTIVE EARTH TERMINAL of the PERMANENTLYINSTALLED ME EQUIPMENT is connected to theexternal protective earthing system

N/A

7.5.2 Technical description includes methods for cleaningand disinfection or cleaning and sterilization for MEEQUIPMENT and ACCESSORIES requiring professionalhygienic maintenance prior to reuse (see 7.4.7):

N/A

– Before and after any type of service PROCEDURE N/A

– When the ME EQUIPMENT is transferred to anotherPATIENT

N/A

8 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHERHAZARDS

N/A

8.1 A LAY OPERATOR in the HOME HEALTHCAREENVIRONMENT can perform the cleaning or cleaningand disinfection PROCESSES when intended (see7.4.7)

N/A


EN 60601-1-11


USABILITY of each such PROCESS pertaining to a LAYOPERATOR was investigated by the USABILITYENGINEERING PROCESS..................................................:


N/A

8.2 A LAY OPERATOR in the HOME HEALTHCAREENVIRONMENT can perform the cleaning andsterilization PROCESSES when intended (see 7.4.7)

N/A

USABILITY of each such PROCESS pertaining to a LAYOPERATOR was investigated by the USABILITYENGINEERING PROCESS


N/A

8.3 Additional requirements for ingress of water or particulate matter into MEEQUIPMENT and ME SYSTEMS

N/A

8.3.1 TRANSIT-OPERABLE, HANDHELD, and BODY-WORN MEEQUIPMENT maintained BASIC SAFETY and ESSENTIALPERFORMANCE after undergoing the test of IEC60529 for at least IP 22................................................ :

N/A

All other ME EQUIPMENT maintained BASIC SAFETYand ESSENTIAL PERFORMANCE after undergoing thetest of IEC 60529 for at least IP21..............................:

N/A

For PORTABLE ME EQUIPMENT intended to be usedonly while in a carrying case, IP21 met with the MEEQUIPMENT in its the carrying case

N/A

Maintenance of BASIC SAFETY and ESSENTIALPERFORMANCE VERIFIED

N/A

8.3.2 ENCLOSURES of the non-ME EQUIPMENT parts of theME SYSTEMS provide the degree of protectionagainst harmful ingress of water or particulatematter equivalent to equipment complying with theirrespective IEC or ISO safety standards

N/A

Tests of IEC 60529:1989 conducted with theequipment placed in the least favourable position ofNORMAL USE and the ENCLOSURES inspected

N/A

8.4 Additional requirements for interruption of the power supply/SUPPLY MAINS toME EQUIPMENT and ME SYSTEM

N/A

ME EQUIPMENT or ME SYSTEM with ESSENTIALPERFORMANCE intended to actively keep alive orresuscitate a PATIENTmaintained its ESSENTIALPERFORMANCE for a sufficient time or for a sufficientnumber of PROCEDURES when loss or failure ofSUPPLY MAINS or near depletion INTERNALELECTRICAL POWER SOURCE occurred

N/A

The time or number of PROCEDURES remainingallowed alternative life-supporting methods to beemployed

N/A

Optionally, an INTERNAL ELECTRICAL POWER SOURCEwas used to maintain ESSENTIAL PERFORMANCE........:

N/A

Optionally, independent means were used toprovide ESSENTIAL PERFORMANCE................................:

N/A


EN 60601-1-11


Instructions for use disclose the time or number ofprocedures available following a loss or failure ofthe SUPPLY MAINS or near depletion of the INTERNALELECTRICAL POWER SOURCE

N/A

Instructions for use describes the alternative life-supporting methods to be employed

N/A

The technical description describes methods thatcan be employed for longer periods

N/A

ME EQUIPMENT or ME SYSTEM with ESSENTIALPERFORMANCE intended to actively keep alive orresuscitate a PATIENT with no INTERNAL ELECTRICALPOWER SOURCE is equipped with an ALARM SYSTEMthat includes at least a MEDIUM PRIORITY ALARMCONDITION indicating power failure ............................:

N/A

ME EQUIPMENT or ME SYSTEM with ESSENTIALPERFORMANCE intended to actively keep alive orresuscitate a PATIENT with an INTERNAL ELECTRICALPOWER SOURCE is equipped with an automaticswitchover to INTERNAL ELECTRICAL POWER SOURCE

N/A

ME EQUIPMENT or ME SYSTEM with ESSENTIALPERFORMANCE intended to actively keep alive orresuscitate a PATIENT with an INTERNAL ELECTRICALPOWER SOURCE is equipped with an ALARM SYSTEMthat includes at least a MEDIUM PRIORITY TECHNICALALARM CONDITION indicating the INTERNALELECTRICAL POWER SOURCE is nearing insufficientremaining power for operation

N/A

TECHNICAL ALARM CONDITION provides sufficient timeor sufficient number of procedures for a LAYOPERATOR to act

N/A

A TECHNICAL ALARM CONDITION of at least LOWPRIORITY remained active until the INTERNALELECTRICAL POWER SOURCE returned to a levelabove the ALARM LIMIT or until depleted

N/A

It was not possible to inactivate the visual ALARMSIGNAL of this TECHNICAL ALARM CONDITION

N/A

Functional tests conducted, and the RISKMANAGEMENT FILE inspected........................................ :

See RISK MANAGEMENT Table8.4

N/A

8.5 Additional requirements for an INTERNAL ELECTRICAL POWER SOURCE P

8.5.1 ME EQUIPMENT provided with a means for theOPERATOR to determine state of the INTERNALELECTRICAL POWER SOURCE when the is essentialfor BASIC SAFETY or ESSENTIAL PERFORMANCE or tocontrol risks associated with loss of ESSENTIALPERFORMANCE

P

State of INTERNAL ELECTRICAL POWER SOURCEindicated by:

P

- number of PROCEDURES remaining; P


EN 60601-1-11


-remaining operating time; P

-percentage of the remaining operating time orenergy; or

P

-“fuel” gauge P

Instructions described method to determine state ofINTERNAL ELECTRICAL POWER SOURCE

P

8.5.2 Means, other than labelling, provided to preventRISK of swallowing coin/button cells

N/A

Replacement of button cell require use of TOOL N/A

9 ACCURACY OF CONTROLS AND INSTRUMENTS AND PROTECTIONAGAINST HAZARDOUS OUTPUTS

N/A

The RISKS associated with USABILITY in the HOME HEALTHCARE ENVIRONMENT forOPERATOR PROFILES including a LAY OPERATOR when performing the USABILITYENGINEERING PROCESS include at least the following considerations:

N/A

– changes of controls N/A

– unexpected movement N/A

– potential for misconnection N/A

– potential for improper operation, or unsafe use N/A

– potential for confusion as to current operationalmode

N/A

– change in the transfer of energy or substance N/A

- exposure to environmental conditions specified inthis standard

N/A

– exposure to biological materials, and N/A

– small parts being inhaled or swallowed N/A

Particular emphasis placed on the limited training ofa LAY OPERATOR with respect to the ability tointervene and maintain BASIC SAFETY and ESSENTIALPERFORMANCE.

N/A

The MANUFACTURER’S USABILITY ENGINEERINGPROCESS included the least capable intended LAYOPERATOR or LAY RESPONSIBLE ORGANIZATION

N/A

USABILITY ENGINEERING FILE inspected forcompliance .................................................................. :


N/A

10 CONSTRUCTION OF ME EQUIPMENT P

10.1 Additional requirements for mechanical strength P

10.1.1 Additions to Table 28 Mechanical strength test of thebase standard, conducted as indicated in Table 1,Mechanical strength test applicability, non-TRANSIT-OPERABLE, and Table 2, Mechanical strength testapplicability, TRANSIT-OPERABLE

P


EN 60601-1-11


10.1.2 ME EQUIPMENT, its parts, and mountingACCESSORIES, intended for non-TRANSIT-OPERABLEuse displayed adequate mechanical strength whensubjected to mechanical stress caused by NORMALUSE, including pushing, impact, dropping and roughhandling (not applicable to FIXED and STATIONARY MEEQUIPMENT)

P

ME EQUIPMENT maintained BASIC SAFETY and ESSENTIAL PERFORMANCE aftermechanical tests

P

OPERATOR-re-settable protective devices that can bereset without the use of a TOOL were, optionally,reset prior to the evaluation of BASIC SAFETY andESSENTIAL PERFORMANCE

P

a) Shock tests conducted in accordance with IEC60068-2-27:2008........................................................... :

See Appended Table 10.1.2a P

b) Broad-band random vibration tests conducted inaccordance with IEC 60068-2-64:2008, using thefollowing conditions....................................................... :

See Appended Table 10.1.2b P

10.1.3 ME EQUIPMENT, parts, and mounting ACCESSORIES forTRANSIT-OPERABLE use displayed adequatemechanical strength when subjected to pushing,impact, dropping, rough handling, and rigorousconditions of PATIENTmovement in NORMAL USE aswell as transportation by trolleys, carts, roadvehicles, trains, ships, and aircraft

N/A

ME EQUIPMENT maintained BASIC SAFETY andESSENTIAL PERFORMANCE after the following tests:

N/A

a) Shock tests conducted on other than HAND-HELDME EQUIPMENT, parts, and mounting ACCESSORIES inaccordance with IEC 60068-2-27:2008

N/A

1) Test type: Type 1...................................................... : See Appended Table 10.1.3a1 N/A

2) Test type: Type 2...................................................... : See Appended Table 10.1.3a2 N/A

b) Shock tests conducted on HAND-HELD MEEQUIPMENT, parts, and mounting ACCESSORIES inaccordance with IEC 60068-2-27:2008

N/A

1) Test type: Type 1...................................................... : See Appended Table 10.1.3b1 N/A

2) Test type: Type 2...................................................... : See Appended Table 10.1.3b2 N/A

c) Broad-band random vibration test conducted onME EQUIPMENT, parts, and mounting ACCESSORIES inaccordance with IEC 60068-2-64:2008...................... :

See Appended Table 10.1.3c N/A

d) Free fall tests conducted on PORTABLE and MOBILEME EQUIPMENT, parts, and mounting ACCESSORIESper IEC 60068-2-31:2008, using PROCEDURE 1 ....... :

See Appended Table 10.1.3d N/A

BASIC SAFETY and ESSENTIAL PERFORMANCE weremaintained

N/A


EN 60601-1-11


10.2 Controls of ME EQUIPMENT intended for use by a LAYOPERATORY that can affect BASIC SAFETY orESSENTIAL PERFORMANCE protected from accidentalor unauthorized changes or adjustments

N/A

OPERATOR-adjustable controls used for calibrationinclude a means to prevent unintentional changesfrom the intended position

N/A

11 PROTECTION AGAINST STRANGULATION OR ASPHYXIATION N/A

Means provided to control the RISK of strangulationand asphyxiation of the PATIENT and others to anacceptable level

N/A

EQUIPMENT and RISK MANAGEMENT FILE inspected.....: See RISK MANAGEMENT Table11

N/A

12 ADDITIONAL REQUIREMENTS FOR ELECTROMAGNETIC EMISSIONS OF MEEQUIPMENT AND ME SYSTEMS

N/A

ME EQUIPMENT and ME SYSTEMS intended for HOMEHEALTHCARE ENVIRONMENT are Class B according toCISPR 11:2009..............................................................:

See attached IEC 60601-1-2:2014 EMC Test Report

N/A

13 ADDITIONAL REQUIREMENTS FOR ALARM SYSTEMS OF ME EQUIPMENTAND ME SYSTEMS

N/A

13.1 Each HIGH PRIORITY and MEDIUM PRIORITY ALARMCONDITION causes generation of auditory ALARMSIGNALS per IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012, except when equipment isconnected to a DISTRIBUTED ALARM SYSTEM intendedfor confirmed deliver of ALARM CONDITIONS includingthe generation of auditory ALARM SIGNALS per IEC60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012....................................................... :

See attached IEC 60601-1-8Report

N/A

13.2 For ME EQUIPMENT and ME SYSTEMS intended toactively keep alive or resuscitate a PATIENT, reducingthe auditory ALARM SIGNAL volume T below audiblelevels resulted in the following was not possible,except when the ALARM SYSTEM was connected to aDISTRIBUTED ALARM SYSTEM that included generationof auditory ALARM SIGNALS per IEC 60601-1-8:2006and IEC 60601-1-8:2006/AMD1:2012

N/A


EN 60601-1-11


4.2.2 RM RESULTS TABLE: Permissible environmental conditions of transport andstorage, between uses, indicated in instructions for use

N/A

Clauseof ISO14971

Document Ref. in RMF(Document No. & paragraph)

Result - Remarks Verdict

4.2.3.1 RM RESULTS TABLE: Environmental operating conditions - Continuousoperating conditions

N/A

Clauseof ISO14971



7.4.1 RM RESULTS TABLE: Additional requirements for warning and safety notices N/A

Clauseof ISO14971



4.24.34.456.2

7.4.5 RM RESULTS TABLE: : Additional requirements for operating instructions N/A

Clause ofISO14971



4.34.456.2


EN 60601-1-11


8.4 RM RESULTS TABLE: Additional requirements for interruption of powersupply / supply mains to ME Equipment and ME Systems

N/A

Clause ofISO14971



4.24.356.26.36.46.56.66.7

10.1.2a TABLE: Shock test (IEC 60068-2-27:2008), using the following conditions*:

Peak acceleration................................................... : 150 m/s2 (15 g)

Duration................................................................... : 11 ms

Pulse shape............................................................ : half-sine

Number of shocks.................................................. : 3 shocks per direction per axis (18 total)

Direction ShockApplied

Axis Shock Applied BASIC SAFETY andESSENTIAL PERFORMANCEmaintained? Yes/No

Remarks

Positive X axis2 Yes The enclosure shows nocracks and there is nodamaged or loosing part insidethe product after test.The EUT worked as normaland passed the dielectricstrength test.

Negative X axis2 Yes

Positive Y axis2 Yes

Negative Y axis2 Yes

Positive Z axis2 Yes

Negative Z axis2 Yes

Supplementary information:*(NOTE 1 This represents Class 7M1 as described in IEC TR 60721-4-7:2001 [6])NOTE 2 X, Y & Z represent normal axises of six surfaces of EUT.)NOTE 3 EUT was repeatedly tested with all the types of plug portion attached.


EN 60601-1-11


10.1.2b TABLE: Broad-band random vibration test (IEC 60068-2-64:2008) using thefollowing conditions*:

P

1 Acceleration amplitude........................................... : 10 Hz to 100 Hz: 1,0 (m/s2)2/Hz

2 Acceleration amplitude........................................... : 100 Hz to 200 Hz: – 3 db per octave

3 Acceleration amplitude........................................... : 200 Hz to 2 000 Hz: 0,5 (m/s2)2/Hz

Duration.................................................................... : 30 min per perpendicular axis (3 total)

Perpendicular axissubjected to broad-bandrandom vibration test

Accelerationamplitude

BASIC SAFETY andESSENTIAL PERFORMANCEmaintained? Yes/No

Remarks

1 1 Yes The enclosure shows nocracks and there is nodamaged or loosing partinside the product after test.The EUT worked as normaland passed the dielectricstrength test.

2 1 Yes

3 1 Yes

1 2 Yes

2 2 Yes

3 2 Yes

1 3 Yes

2 3 Yes

3 3 Yes

Supplementary information:* (NOTE 2 This represents Class 7M1 and 7M2 as described in IEC TR 60721-4-7:2001)NOTE 2 EUT was repeatedly tested with all the types of plug portion attached.


EN 60601-1-11


10.1.3a1 TABLE: Shock test (IEC 60068-2-27:2008) for other than HAND-HELD EQUIPMENT,parts, and mounting ACCESSORIES under the following conditions (Test Type 1):

N/A


Duration................................................................... : 11 ms




Axis ShockApplied

BASIC SAFETY and ESSENTIALPERFORMANCE maintained?

Yes/NoRemarks

Supplementary information:* (NOTE 3 This represents Class 7M2 as described in IEC/TR 60721-4-7:2001 [6])


EN 60601-1-11


10.1.3a2 TABLE: Shock test (IEC 60068-2-27:2008) on other than HAND-HELD MEEQUIPMENT, parts, and mounting ACCESSORIES under the following conditions(Test Type 2):

N/A


Duration................................................................... : 6 ms




Axis ShockApplied


Yes/NoRemarks



EN 60601-1-11


10.1.3b1 TABLE: Shock test (IEC 60068-2-27:2008) on HAND-HELD ME EQUIPMENT parts,and mounting ACCESSORIES using the following conditions (Test Type 1):

N/A


Duration................................................................... : 11 ms




Axis ShockApplied


Yes/NoRemarks

Supplementary information:*(NOTE 4 This represents Class 7M3 as described in IEC/TR 60721-4-7:2001. (Test Type 1)


EN 60601-1-11


10.1.3b2 TABLE: Shock test (IEC 60068-2-27:2008) on HAND-HELD ME EQUIPMENT parts, andmounting ACCESSORIES using the following conditions (Test Type 2):

N/A


Duration................................................................... : 6 ms




Axis ShockApplied


Yes/NoRemarks



EN 60601-1-11


10.1.3c TABLE: Broad-band random vibration test (IEC 60068-2-64:2008) on MEEQUIPMENT, parts, and mounting ACCESSORIES using the following conditions*:

N/A

1 Acceleration amplitude........................................... : 10 Hz to 100 Hz: 1,0 (m/s2)2/Hz

2 Acceleration amplitude........................................... : 100 Hz to 200 Hz: - 3 db per octave

3 Acceleration amplitude........................................... : 200 Hz to 2 000 Hz: 0,5 (m/s2)2/Hz

Duration.................................................................... : 30 min per perpendicular axis (3 total)

Perpendicular axissubjected to broad-bandrandom vibration test

Accelerationamplitude

BASIC SAFETY andESSENTIAL PERFORMANCEmaintained? Yes/No

Remarks

1 1

2 1

3 1

1 2

2 2

3 2

1 3

2 3

3 3

Supplementary information:*(NOTE 5 This represents Class 7M1 and 7M2 as described in IEC/TR 60721-4-7:2001)


EN 60601-1-11


10.1.3d TABLE: Free fall test (IEC 60068-2-31:2008), using PROCEDURE 1, on PORTABLEand MOBILE ME EQUIPMENT, parts, and mounting ACCESSORIES (with carrying caseif intended), under the following conditions*:

N/A

1 Fall height for mass ≤ 1 kg..................................... : 0,25 m

2 Fall height for mass > 1 kg and ≤ 10 Kg............... : 0,1 m

3 Fall height for mass > 10 kg and ≤ 50 Kg.............: 0,05 m

4 Fall height for mass > 50 kg................................... : 0,01 m

Specifiedaltitude (m)

Mass(Kg) Fall No.


Yes/NoRemarks

0,25 ≤ 1 1 - -

0,25 ≤ 1 2 - -

0,1 > 1 & ≤ 10 1 - -

0,1 > 1 & ≤ 10 2 - -

0,05 > 10 & ≤ 50 1 - -

0,05 > 10 & ≤ 50 2 - -

0,01 > 50 1 - -

0,01 > 50 2 - -

Supplementary information:(*NOTE 6 This represents Class 7M2 as described in IEC/TR 60721-4-7:2001)

11.0 RM RESULTS TABLE: PROTECTION AGAINST STRANGULATION ANDASPHYXIATION

N/A

Clauseof ISO14971



4.34.456.26.36.46.56.6Supplementary information:


Photo documentation P

Photo 1 General appearance of the EUT





***End of the report***

Page 1 of 26 Report No.: A20032641ER-01

EMC TEST REPORT

Product： Non-contact Electronic Thermometer

Trade Name： bingzun

Model Name： R3,R5,R6,R7,R8,R9,R11

Serial Model：N/A

Report No.： A20032641ER-01

Prepared for

Henan BingZun Industrial Co., Ltd50 meters next to the south of Guihua Villa, Xin'an Industry Cluster District, Luoyang

City, Henan Province, China

Prepared by

United Testing Technology (Hong Kong) Limited

Unit 04,7/F,Bright Way Tower,No.33 Mong Kok Road, Kowloon, HK.


TEST RESULT CERTIFICATION

Applicant’s name.................... : Henan BingZun Industrial Co., Ltd

Address...................................... : 50 meters next to the south of Guihua Villa, Xin'an Industry ClusterDistrict, Luoyang City, Henan Province, China

Manufacture's Name.............. : DONG GUAN TOP RAY ILLUMINATION CO., LTD.

Address...................................... : BUILDING, YIQUAN INDUSTRIAL ZONE, SHAYI ROAD, SHABUDIST., DALANG TOWN, DONG GUAN CITY.

Product description

Product name............................... : Non-contact Electronic Thermometer

Trade Mark.................................: bingzun

Model and/or type reference . : R3,R5,R6,R7,R8,R9,R11

Standards..................................:EN 60601-1-2: 2015EN 55011: 2016/A1: 2017

This device described above has been tested by United Testing Technology (HongKong) Limited and the test results show that the equipment under test (EUT) is incompliance with the EMC Directive 2014/30/EU requirements. And it is applicable only tothe tested sample identified in the report.This report shall not be reproduced except in full, without the written approval of UNI, thisdocument may be altered or revised by United Testing Technology (Hong Kong) Limitedpersonnel only, and shall be noted in the revision of the document.

Date of Test............................................... :Date (s) of performance of tests...............: Mar. 20, 2020 ~ Mar. 25, 2020Date of Issue.............................................. : Mar. 25, 2020Test Result.................................................. : Pass

Prepared by:Bob liao/Editor

Reviewer:Kahn yang/Supervisor

Approved & Authorized Signer:Liuze/Manager


Table of Contents Page

1 TEST SUMMARY 4

2 GENERAL INFORMATION 62.1 GENERAL DESCRIPTION OF EUT 62.2 DESCRIPTION OF THE TEST MODES 72.3 DESCRIPTION OF TEST SETUP 72.4 DESCRIPTION TEST PERIPHERAL AND EUT PERIPHERAL 82.5 MEASUREMENT INSTRUMENTS LIST 9

3 RADIATED EMISSION MEASUREMENT 113.1 RADIATED EMISSION LIMIT 113.2 TEST SETUP 113.3 TEST PROCEDURE 123.4 TEST RESULT 12

4 EMC IMMUNITY TEST 154.1 STANDARD COMPLIANCE/SERVRITY LEVEL/CRITERIA 154.2 GENERAL PERFORMANCE CRITERIA 15

5 ELECTROSTATIC DISCHARGE IMMUNITY TEST (ESD) 165.1 TEST SPECIFICATION 165.2 TEST SETUP 165.3 TEST PROCEDURE 175.4 TEST RESULT 18

6 RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST

(RS) 196.1 TEST SPECIFICATION 196.2 TEST SETUP 196.3 TEST PROCEDURE 206.4 TEST RESULT 21

7 POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST (PFMF) 227.1 TEST SPECIFICATION 227.2 TEST SETUP 227.3 TEST PROCEDURE 237.4 TEST RESULT 23

8 PHOTO OF EUT 24

9 PHOTO OF TEST 26


1 TEST SUMMARY

TEST RESULTS

Test procedures according to the technical standards:

EMC Emission

Standard Test Item Limit Judgment Remark

EN 55011: 2016/A1:2017

Conducted Emission Class B N/A

Radiated Emission Class B PASS NOTE (1)

EN 61000-3-2:2014 Harmonic Current Emission —— N/A NOTE (2)EN 61000-3-3:2013 Voltage Fluctuations & Flicker —— N/A

EMC Immunity

SectionEN 60601-1-2: 2015 Test Item Performan

ce Criteria Judgment Remark

EN 61000-4-2:2009 Electrostatic Discharge B PASS

EN 61000-4-3:2006+A1:2008+A2:2010 RF Electromagnetic Field A PASS

EN 61000-4-4:2012 Fast Transients B N/A

EN 61000-4-5:2014/A1:2017 Surges B N/A

EN 61000-4-6:2014/AC:2015 Injected Current A N/A

EN 61000-4-8:2010 Power Frequency MagneticField A PASS

EN 61000-4-11:2004/A1:2017

Volt. InterruptionsVolt. Dips B / C / C N/A NOTE (3)

Note:(1) If the highest frequency of the internal sources of the EUT is less than 108 MHz, the measurement shall

only be made up to 1 GHz.If the highest frequency of the internal sources of the EUT is between 108 MHz and 500 MHz, themeasurement shall only be made up to 2 GHz.If the highest frequency of the internal sources of the EUT is between 500 MHz and 1GHz, themeasurement shall only be made up to 5 GHz.If the highest frequency of the internal sources of the EUT is above 1 GHz, the measurement shall bemade up to 5 times of the highest frequency or 6 GHz, whichever is less.

(2) The power consumption of EUT is less than 75W and no Limits apply.(3) Voltage Dip: 100% reduction – Performance Criteria B

Voltage Dip: 30% reduction – Performance Criteria CVoltage Interruption: 100% Interruption – Performance Criteria C

(4) For client’s request and manual description, the test will not be executed.(5) “N/A” denotes test is not applicable in this Test Report.


TEST FACTORY

Test Firm : United Testing Technology (Hong Kong) Limited

Address : Unit 04,7/F,Bright Way Tower,No.33 Mong Kok Road, Kowloon, HK.

The testing quality system of our laboratory meets with ISO/IEC-17025 requirements. This

approval result is accepted by MRA of APLAC.

MEASUREMENT UNCERTAINTY

The reported uncertainty of measurement y ± U, where expended uncertainty U is based on a

standard uncertainty multiplied by a coverage factor of k=2, providing a level of confidence of

approximately 95 %.

A. Conducted Measurement:Test Site Method Measurement Frequency Range U, (dB) NOTE

UNI01 ANSI 9KHz ~ 150KHz 3.18

150 KHz ~ 30MHz 2.70

B. Radiated Measurement:Test Site Method Measurement Frequency Range U, (dB) NOTE

UNI02 ANSI 9KHz ~ 30MHz 2.50

30MHz ~ 200MHz 3.43

200MHz ~ 1000MHz 3.57

1GHz ~ 6 GHz 4.13


2 GENERAL INFORMATION

2.1 GENERAL DESCRIPTION OF EUT

Equipment: Non-contact Electronic Thermometer

Trade Mark: N/A

Model Name: JIA-1000

Serial No.: N/A

Model Difference: N/A

Product Description:

The EUT is a Non-contact Electronic Thermometer.

Operating frequency: N/AConnecting I/O port: N/A

Based on the application, features, or specification exhibitedin User's Manual, the EUT is considered as an ITE/ComputingDevice. More details of EUT technical specification, pleaserefer to the User's Manual.

Power Source: DC 3.0V


2.2 DESCRIPTION OF THE TEST MODES

To investigate the maximum EMI emission characteristics generates from EUT, the test system

was pre-scanning tested base on the consideration of following EUT operation mode or test

configuration mode which possible have effect on EMI emission level. Each of these EUT

operation mode(s) or test configuration mode(s) mentioned above was evaluated respectively.

Pretest Mode Description

Mode 1 Running

For Radiated Test


Mode 1 Running

For EMS Test


Mode 1 Running

Note: The test modes were carried out for all operation modes (include link and idle).

2.3 DESCRIPTION OF TEST SETUP

Note: The EUT tested system was configured as upper figure, unless otherwise a special

operating condition is specified in the following during the testing.

AE EUT


2.4 DESCRIPTION TEST PERIPHERAL AND EUT PERIPHERAL

The EUT has been tested as an independent unit together with other necessary accessories or

support units. The following support units or accessories were used to form a representative test

configuration during the tests.

Item Equipment Mfr/Brand Model/Type No. Note

E-1 Non-contact ElectronicThermometer N/A JIA-1000 EUT

Item Shielded Type Ferrite Core Length Note

Note:

1. The support equipment was authorized by Declaration of Confirmation.

2. For detachable type I/O cable should be specified the length in cm in『Length』column.

3. “YES” is means “shielded” “with core”; “NO” is means “unshielded” “without core”.


2.5 MEASUREMENT INSTRUMENTS LIST

Item Equipment Manufacturer Model No. Serial No. Calibrated until

Conduction Emissions Measurement

1 Conducted EmissionTest Software EZ-EMC Ver.CCS-3A1-CE N/A N/A

2 AMN Schwarzbeck NNLK8121 8121370 2020.10.15

3 AMN ETS 3810/2 00020199 2020.10.15

4 AAN TESEQ T8-Cat6 38888 2020.10.15

5 Pulse Limiter CYBRTEK EM5010 E115010056 2020.05.26

6 EMI Test Receiver Rohde&Schwarz ESCI 101210 2020.10.15

Radiated Emissions Measurement

1 Radiated EmissionTest Software EZ-EMC Ver.CCS-03A1 N/A N/A

2 Horn Antenna Sunol DRH-118 A101415 2020.10.18

3 Broadband HybridAntenna Sunol JB1 A090215 2020.11.15

4 PREAMP HP 8449B 3008A00160 2020.10.21

5 PREAMP HP 8447D 2944A07999 2020.05.26

6 EMI Test Receiver Rohde&Schwarz ESR3 101891 2020.10.15

7 MXA Signal Analyzer Keysight N9020A MY51110104 2020.10.15

8 Active Loop Antenna Com-Power AL-310R 10160009 2020.05.28

9 Horn Antenna Schwarzbeck BBHA9120D 9120D-1680 2020.05.28

10 Horn Antenna A-INFOMW LB-180400-KF J211060660 2020.10.23

11 Loop Antenna Beijing dazeTechnology ZN30401 13015 2020.10.15

12 EM Clamp Schwarzbeck MDS21 03350 2020.10.20

Harmonic / Flicker Measurement

1 Power Analyzer California Instrumnets PACS-1 X71719 2020.10.15

2 AC Power Source California Instrumnets 5001ix HK53570 2020.10.15

Electrostatic Discharge Test

1 ESD Generator EVERFINE EMS61000-2A P185811CA8371121 2020.10.17

RS Test

1 Power Meter Agilent E4419B QB4331226 2020.10.10

2 Power Sensor Agilent 8481A MY41092622 2020.10.10

3 Power Sensor Agilent 8481A US37296783 2020.10.10

4 Signal Generator Agilent N5182A MY46240556 2020.10.10

5 Power Amplifier MICOTOP MPA-80-1000-250 1711489 2020.10.10

6 Power Amplifier MICOTOP MPA-1000-3000-75 1711488 2020.10.10

7 Power Amplifier MICOTOP MPA-3000-6000-50 MPA1706275 2020.10.10

8 Bilog Antenna TESEQ CBL6111D 34678 2020.10.10

9 Horn Antenna Schwarzbeck BBHA9120D 9120D-1680 2020.05.28


Item Equipment Manufacturer Model No. Serial No. Calibrated until

Electrical Fast Transient / Burst Immunity Test

1 EMS Test ControlSystem Shanghai Lioncel SCU-614AS SCU614S0160601 N/A

2 EFT/B Generator Shanghai Lioncel EFT-404S EFT404S0160601 2020.10.15

Surge Test

1 EMS Test ControlSystem Shanghai Lioncel SCU-614AS SCU614S0160601 N/A

2 Surge Generator Shanghai Lioncel LSG-506S LSG506S0160601 2020.10.15

3 CDN Shanghai Lioncel CDN-532S CDN532S0160601 2020.10.15

CS Test

1 CS SCHLODER CDG-6000-25 126A1280/2014 2020.10.10

2 CDN SCHLODER CDN-M2+3 A2210275/2014 2020.10.10

3 EM Clamp SCHLODER EMCL-20 132A1283 2020.10.10

4 Attenuator Nemtest ATT-6DB-100 A100W224 2020.10.10

5 Audio Analyzer R&S UPL 100419 2020.10.10

6Universal RadioCommunication

TesterR&S CMW500 117239 2020.10.10

7Universal RadioCommunication

TesterR&S CMU200 111764 2020.10.10

8 Audio Analyzer R&S UPL 100689 2020.10.10

9 Audio BreakthroughShielding Box SKET SB_ABT/C35 N/A 2020.10.10

10 Ear Simulator SKET AE_ABT/C35 N/A 2020.10.10

11 Mouth Simulator SKET AM_ABT/C35 N/A 2020.10.10

12 1KHz StandardSource SKET MSC_ABT/C35 N/A 2020.10.10

Power-frequency magnetic fields Test

1 Magnetic Field TestSystem Shanghai Lioncel PMF801C-T PMF801C-T016070

1 2020.05.26

Voltage dips and interruptions Test

1 Voltage SAGSimulator Shanghai Lioncel VDS-1101 VDS11010160601 2020.10.15

2 Adjustable PowerSupply Shanghai Lioncel RGL-210 RGL2100151001 N/A


3 RADIATED EMISSION MEASUREMENT

3.1 RADIATED EMISSION LIMIT

Below 1000MHz:

Above 1000MHz:

Note:1. The tighter limit applies at the band edges.2. Emission level (dBuV/m)=20log Emission level (uV/m).

3.2 TEST SETUP

1. Radiated Emission Test-Up Frequency Below 1000MHz

Frequency(MHz)

Class A Class B

10m 3m 10m 3m

dBuV/m dBuV/m dBuV/m dBuV/m

30~230 40 50 30 40

230~1000 47 57 37 47

Frequency(MHz)

Class A Class B

PK AV PK AV

dBuV/m dBuV/m dBuV/m dBuV/m

1000~3000 76 56 70 50

3000~6000 80 60 74 54


2. Radiated Emission Test-Up Frequency Above 1000MHz

3.3 TEST PROCEDURE

1. The EUT was placed on the top of a rotating table 0.8 meters above the ground at a 3 meter semi-anechoicchamber room. The table was rotated 360 degrees to determine the position of the highest radiation.

2. The EUT was set 3 meters away from the interference-receiving antenna, which was mounted on the top ofa variable-height antenna tower.

3. The height of antenna is varied from 1 meter to 4 meters above the ground to determine the maximumvalue of the field strength. Both horizontal and vertical polarizations of the antenna are set to make themeasurement.

4. For each suspected emission, the EUT was arranged to its worst case and then the antenna was tuned toheights from 1 meter to 4 meters and the rotatable table was turned from 0 degrees to 360 degrees to findthe maximum reading.

5. The test-receiver system was set to quasi-peak detect function and specified bandwidth with maximumhold mode when the test frequency is below 1GHz.

6. For the actual test configuration, please refer to the related Item EUT Test Photos.

3.4 TEST RESULT

PASS


Temperature: 24℃ Relative Humidity: 48%

Test Voltage: DC 3.0V Pressure: 1010hPa

Test Mode: Running Polarization: Horizontal

Remark: Absolute Level = Reading Level + Factor, Margin = Absolute Level – LimitFactor = Ant. Factor + Cable Loss – Pre-amplifier

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Test Mode: Running Polarization: Vertical

Remark: Absolute Level = Reading Level + Factor, Margin = Absolute Level – LimitFactor = Ant. Factor + Cable Loss – Pre-amplifier



4 EMC IMMUNITY TEST

4.1 STANDARD COMPLIANCE/SERVRITY LEVEL/CRITERIA

TestsStandard No. TEST SPECIFICATION Test Mode

Test PortsPerformCriteria

ESDIEC/EN 61000-4-2

Air dischargeContact discharge Direct Mode

B

B

RSIEC/EN 61000-4-3

80 MHz to 2700 MHz,1000Hz, 80%,AM modulated

Enclosure A

Power FrequencyMagnetic Field

IEC/EN 61000-4-850/60 Hz Enclosure A

4.2 GENERAL PERFORMANCE CRITERIA

According to EN 60601-1-2 standard, the general performance criteria as following:

Criterion A

The equipment shall continue to operate as intended without operator intervention. Nodegradation of performance, loss of function or change of operating state is allowed below aperformance level specified by the manufacturer when the equipment is used as intended.The performance level may be replaced by a permissible loss of performance. If the minimumperformance level or the permissible performance loss is not specified by the manufacturer,then either of these may be derived from the product description and documentation, and bywhat the user may reasonably expect from the equipment if used as intended.

Criterion B

During the application of the disturbance, degradation of performance is allowed. However,no unintended change of actual operating state or stored data is allowed to persist after thetest. After the test, the equipment shall continue to operate as intended without operatorintervention; no degradation of performance or loss of function is allowed, below aperformance level specified by the manufacturer, when the equipment is used as intended.The performance level may be replaced by a permissible loss of performance.If the minimum performance level (or the permissible performance loss), or recovery time, isnot specified by the manufacturer, then either of these may be derived from the productdescription and documentation, and by what the user may reasonably expect from theequipment if used as intended.

Criterion C

Loss of function is allowed, provided the function is self-recoverable, or can be restored bythe operation of the controls by the user in accordance with the manufacturer’s instructions. Areboot or re-start operation is allowed.Information stored in non-volatile memory, or protectedby a battery backup, shall not be lost.


5 ELECTROSTATIC DISCHARGE IMMUNITY TEST (ESD)

5.1 TEST SPECIFICATION

Basic Standard: IEC/EN 61000-4-2

Discharge Impedance: 330 ohm / 150 pF

Required Performance: B

Discharge Voltage: Air Discharge：2kV/4kV/8kV/15kVContact Discharge：8kV

Polarity: Positive & Negative

Number of Discharge: Air Discharge: min. 20 times at each test pointContact Discharge: min. 200 times in total

Discharge Mode: Single Discharge

Discharge Period: 1 second minimum

5.2 TEST SETUP


Note:

TABLE-TOP EQUIPMENT

The configuration consisted of a wooden table 0.8 meters high standing on the Ground Reference Plane. TheGRP consisted of a sheet of aluminum at least 0.25mm thick. A Horizontal Coupling Plane (1.6m x 0.8m) wasplaced on the table and attached to the GRP by means of a cable with 940k total impedance. The equipmentunder test, was installed in a representative system as described in section 7 of IEC /EN 61000-4-2, and itscables were placed on the HCP and isolated by an insulating support of 0.5mm thickness. A distanceof0.8-meter minimum was provided between the EUT and the walls of the laboratory and any other metallicstructure.

FLOOR-STANDING EQUIPMENT

The equipment under test was installed in a representative system as described in section 7 of IEC/EN61000-4-2, and its cables were isolated from the Ground Reference Plane by an insulating support of 0.1 meterthickness. The GRP was consisted of a sheet of aluminum that is at least 0.25mm thick, and extended at least0.5 meters from the EUT on all sides.

5.3 TEST PROCEDURE

The test generator necessary to perform direct and indirect application of discharges to the EUT in thefollowing manners:1. Electrostatic discharges were applied only to those points and surfaces of the EUT that are accessible tousers during normal operation The test was performed with at least ten single discharges on thepre-selected points in the most sensitive polarity.The time interval between two successive single discharges was at least 1 second.The ESD generator was held perpendicularly to the surface to which the discharge was applied and thereturn cable was at least 0.2 meters from the EUT.Contact discharges were applied to the non-insulating coating, with the pointed tip of the generatorpenetrating the coating and contacting the conducting substrate.Air discharges were applied with the round discharge tip of the discharge electrode approaching the EUTas fast as possible (without causing mechanical damage) to touch the EUT. After each discharge, the ESDgenerator was removed from the EUT and re-triggered for a new single discharge. The test was repeateduntil all discharges were complete.Vertical Coupling Plane (VCP):The coupling plane, of dimensions 0.5m x 0.5m, is placed parallel to, and positioned at a distance 0.1mfrom, the EUT, with the Discharge Electrode touching the coupling plane.The four faces of the EUT will be performed with electrostatic discharge.Horizontal Coupling Plane (HCP):The coupling plane is placed under to the EUT. The generator shall be positioned vertically at a distance of0.1m from the EUT, with the Discharge Electrode touching the coupling plane.The four faces of the EUT will be performed with electrostatic discharge.

2. Air discharges at insulation surfaces of the EUT.It was at least ten single discharges with positive and negative at the same selected point.


5.4 TEST RESULT



Test Mode: Running

Mode Air Discharge Contact DischargePerformCriteria ResultTest level (kV) 2 4 8 15 2 4 6 8

TestLocation + - + - + - + - + - + - + - + -

Slots A A A A A A A A

B

PASS

Surface A A A A A A A A PASS

PASS

PASS



6 RADIATED, RADIO-FREQUENCY, ELECTROMAGNETIC FIELD IMMUNITY TEST (RS)



Required Performance: A

Frequency Range: 80~2700MHz

Field Strength: 10 V/m

Modulation: 1kHz Sine Wave, 80%, AM Modulation

Frequency Step: 1 % of fundamental

Polarity of Antenna: Horizontal and Vertical

Test Distance: 3 m

Antenna Height: 1.5 m

Dwell Time: 1.5x 10-3 decade/s

6.2 TEST SETUP


Note:

TABLE-TOP EQUIPMENT

The EUT installed in a representative system as described in section 7 of IEC/EN 61000-4-3 was placed on anon-conductive table 0.8 meters in height. The system under test was connected to the power and signal wireaccording to relevant installation instructions.


The EUT installed in a representative system as described in section 7 of IEC/EN 61000-4-3 was placed on anon-conductive wood support 0.1 meters in height. The system under test was connected to the power andsignal wire according to relevant installation instructions.

6.3 TEST PROCEDURE

The EUT and support equipment, which are placed on a table that is 0.8 meter above ground and the testingwas performed in a fully-anechoic chamber.The testing distance from antenna to the EUT was 3 meters.The other condition need as following manners:1. The frequency range is swept from 80 MHz to 1000 MHz, 1800 MHz, 2600 MHz, 3500 MHz, 5000 MHz,with the signal 80% amplitude modulated with a 1kHz sine wave. The rate of sweep did not exceed 1.5x10-3 decade/s. Where the frequency range is swept incrementally, the step size was 1% of fundamental.

2. The dwell time at each frequency shall be not less than the time necessary for the EUT to be able torespond.

3. The test was performed with the EUT exposed to both vertically and horizontallypolarized fields on each of the four sides.


6.4 TEST RESULT



Test Mode: Running

FrequencyRange (MHz)

RF FieldPosition

R.F.Field Strength Azimuth Perform

Criteria Result

80~2700 H / V10 V/m (rms)AM Modulated1000Hz, 80%

Front

A PASS

Rear

Left

Right



7 POWER FREQUENCY MAGNETIC FIELD IMMUNITY TEST (PFMF)



Required Performance: A

Frequency Range: 50Hz

Field Strength: 30 A/m

Observation Time: 1 minute

Inductance Coil: Rectangular type, 1mx1m

7.2 TEST SETUP

Note:

TABLE-TOP EQUIPMENT

The equipment shall be subjected to the test magnetic field by using the induction coil of standard dimension (1m x 1 m). The induction coil shall then be rotated by 90 degrees in order to expose the EUT to the test field withdifferent orientations.


The equipment shall be subjected to the test magnetic field by using induction coils of suitable dimensions. Thetest shall be repeated by moving and shifting the induction coils, in order to test the whole volume of the EUT foreach orthogonal direction. The test shall be repeated with the coil shifted to different positions along the side ofthe EUT, in steps corresponding to 50 % of the shortest side of the coil. The induction coil shall then be rotatedby 90 degrees in order to expose the EUT to the test field with different orientations.


7.3 TEST PROCEDURE

The EUT and support equipment, are placed on a table that is 0.8 meter&0.1 meter above a metal groundplane measured 1m*1m min.The other condition need as following manners:1. The equipment cabinets shall be connected to the safety earth directly on the GRP via the earth terminalof the EUT.

2. The cables supplied or recommended by the equipment manufacturer shall be used. 1 meter of all cablesused shall be exposed to the magnetic field.

7.4 TEST RESULT



Test Mode: Running

Test Level(A/m) Inductive Coil Duration (s) Perform

Criteria Result

30 X 60 A PASS

30 Y 60 A PASS

30 Z 60 A PASS



8 PHOTO OF EUT

PHOTO 01

PHOTO 02


PHOTO 03

PHOTO 04


9 PHOTO OF TEST

PHOTO 01

***End of Report***