Attachment 7. IEC 60601-1 Test Report

Page 1 of 49 Ref. No: SCC(10)-617-9-12-LVD/MDDTEST REPORTIEC 60601-1:1988+A1:1991+A2:1995Medical electrical equipmentPart 1: General requirements for safetyReportReport reference No .:Tested by (+ signature).:Reviewed by (+ signature) .:Approved by (+ signature):Date of issue.:Number of pages (Report):SCC(10)-617-9-12-LVD/MDDLiu TongZeng TaoHe Ping2012-10-2249Testing laboratoryName.:Address:Testing location:CHINA CEPREI (SICHUAN) LABORATORYNo. 45 Wenming Dong Road, Longquanyi, Chengdu, 610100 P. R. ChinaSame as aboveClient Name :Address:Ageless Health Industrial Ltd. 3/F, A1 Bldg, Dongshen Sima Industrial Area, No.33 Shenbei Road, Sima Village, Changping Town, Dongguan, Guangdong, ChinaTest specificationStandard:Test procedure :Procedure deviation:Non-standard test method:IEC 60601-1:1988+A1:1991+A2:1995Lab TestingN/AN/ATest report form/blank test reportTest report form No:Master TRF.:Copyright blank test report.:SCC60601-1 Reference IEC 60601-1:1988+A1:1991+A2:1995CHINA CEPREI (SICHUAN) LABORATORYPage 2 of 49 Ref. No: SCC(10)-579-2-10-LVD/MDDTest itemDescription :Trademark .:Model and/or type reference.:Manufacturer:AGE Automatic Wrist Blood Pressure Monitor BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613Ageless Health Industrial Ltd.Equipment mobility.:PortableOperating condition :Intermission Test case verdictsTest case does not apply to the test object.:N/A (Not Applicable)Test item does meet the requirement.:PassTest item does not meet the requirement:FailGeneral remarksThis test report shall not be reproduced except in full without the written approval of the testing laboratory.The test results presented in this report relate only to the object tested.(See remark #) refers to a remark appended to the report.(See appended table) refers to a table appended to the report.Throughout this report a comma is used as the decimal separator.Brief description of the tested sample(s):Ambient temperature: 25 Humidity: 55%Complete test was conducted on BW-601Non-Voice Type: BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613Voice Type: BW-601All the models have the same electric parameter, electrical components. They also have the similar constructions and electrical connections except for outlook. On the basis of these similarities among these models of this manufacturer, this report is also applicable to above-mentioned models.Page 43 of 49 Ref. No: SCC(10)-617-9-12-LVD/MDDIEC 60601-1:1988+A1:1991+A2:1995ClauseRequirement TestResult - RemarkVerdict3GENERAL REQUIREMENTSPass3.1Equipment when transported, stored, installed, operated in normal use and maintained according to the instructions of the manufacturer, causes no safety hazard which could reasonably be foreseen and which is not connected with its intended application in normal condition (N.C.) and in single fault condition (S.F.C.)The equipment causes no hazards when used according the manufacturers instructions.Pass3.4An alternative means of construction is used to that detailed in this standard and it can be demonstrated that an equivalent degree of safety is obtainedNo alternative constructions.N/A5ClassificationPass5.1According to the type of protection against electric shock:Internally Power EquipmentPass5.2According to the degree of protection against electric shockType BPass5.3According to the degree of protection against ingress of water as detailed in the current edition of IEC 529IPX0, ordinary equipment.Pass5.4According to the method(s) of sterilization or disinfection recommended by the manufacturerThese methods are not necessary.N/A5.5According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxideNot suitable for use in the presence of flammable anesthetics or oxygen.N/A5.6According to the mode of operationIntermission operation.Pass6Identification, marking and documentsPassFor the purpose of this clause the following meanings shall apply to identification and marking: permanently affixed; Clearly legible.Comply with the requirementsPass6.1Marking on the outside of EQUIPMENT or EQUIPMENT partsComply with the requirementsPassc)Markings of the specific power supply affixedN/Ad)If marking is not practicable due to size or nature of enclosure, information is included in accompanying documentsPasse)Name and/or trademark of the manufacturer or supplier: Ageless Health Industrial Ltd.Passf)Model or type reference: BW-601, BW-602, BW-603, BW-605, BW-606, BW-611, BW-612, BW-613Passg)Rated supply voltages or voltage range(s)3 VdcPassNumber of phases: N/AType of current: dcPassh)Rated frequency or rated frequency range(s) (Hz): N/Aj)Rated power input (VA, W or A): 1WPassk)Power output of auxiliary mains socket - outletsNot provided.N/Al)Class II symbolN/ASymbol for degree of protection against ingress of water provided: No marking; No water proof.N/ASymbol for protection against electric shock: Type B markPassIf equipment has more than one applied part with different degrees of protection, the relevant symbols are clearly marked on such applied parts, or on or near relevant outletsOnly one applied part is employed.N/ASymbol for protection of defibrillation-proof applied partsNo defibrillation-proof.N/ASymbol 14 from Table DI for defibrillation-proof with protection partly in patient cableNo defibrillation-proof.N/Am)Mode of operation (if no marking, suitable for continuous operation)Not for continuous monitoring.Passn)Types and rating of external accessible fuses: No external accessible fuses.N/Ap)Ratings of external output: No external outputs.N/Aq)Symbol for physiological effect(s):N/A- attention, consult accompanying documentsN/A- non-ionizing radiation, or symbols as adopted by ISO or IEC 417N/Ar)Anaesthetic-proof symbol: AP or APG: Not of category AP or APG.N/As)Dangerous voltage symbolNo accessible dangerous voltage.N/At)Special cooling requirementsNo special cooling requirements.N/Au)Limited mechanical stabilityNo limited mechanical stability.N/Av)Protective packing requirement(s)No special measures have to be taken during transport or storage.N/A- Marking(s) for unpacking safety hazard(s)No special requirement.N/A- Equipment or accessories supplied sterile, marked as sterileN/Ay)Potential equalization terminalNot provided.N/A- Functional earth terminalN/Az)Removable protective meansNo removable protective means.N/ADurability of marking testPass6.2Marking on the inside of EQUIPMENT or EQUIPMENT partsComply with the requirementsPassa)Nominal voltage of permanently installed equipmentThe equipment is not permanently installed.N/Ab)Maximum power loading for heating elements or holders for heating lampsNo heating elements.N/Ac)Dangerous voltage symbolNo high-voltage exceeding 1kV.N/Ad)Type of battery and mode of insertionPass- Marking referring to accompanying documents used for battery not intended to be changed by the operatorN/Ae)Fuses accessible with a tool identified either by type and rating or by a reference to diagramNo fuse marking needed due to board replacement in case of fuse opened.N/Af)Protective earth terminalNo protective earth.N/Ag)Functional earth terminalN/Ah)Supply neutral conductor in permanently installed equipment (N)The equipment is not permanently installed.N/Aj)Markings required in 6.2 f), h), k), and l) remain visible after connection and are not affixed to parts which have to be removedN/A- Markings comply with IEC 445N/Ak)For permanently connected devices the supply connections are clearly marked adjacent to the terminals (or in accompanying documents for small equipment)The equipment is not permanently installed.N/Al)Statement for suitable wiring materials at temperatures over 75CSee above.N/An)Capacitors and/or circuit parts marked as required in Sub-clause 15cN/A6.3Marking of controls and instrumentsPassa)Mains switch clearly identifiedNo mains switch.N/A- ON and OFF positions marked according to Symbols 15 and 16 of table D1 or indicated by an adjacent indicator lightN/Ab)Indication of different positions of control devices and switchesFunctional ON/OFF switch indicated by IEC60417, No. 5010.Passc)Indication of the direction in which the magnitude of the function changes, or an indicating deviceNo such controls.N/Af)The functions of operator controls and indicators are identifiedPassg)Numeric indications of parameters are in SI units except for units listed in Am. 2N/A6.4SymbolsPassa)Symbols used for marking according to Sub-clauses 6.1 to 6.3 shall conform to Appendix D, where applicable. Comply with the requirements Passb)Symbols used for controls and performance shall conform to IEC Publication 878, where applicable.Pass6.5Colours of the insulation of conductorsN/Aa)A protective earth conductor shall be identified throughout its length by green and yellow coloured insulation.No protective earth.N/Ab)Any insulation on conductors inside EQUIPMENT which connect ACCESSIBLE METAL PARTS or other PROTECTIVELY EARTHED parts with a protective function to the PROTECTIVE EARTH TERMINAL shall be identified by the colours green and yellow at least at the termination of the conductors.N/Ac)Identification by green and yellow insulation shall only be used for: PROTECTIVE EARTH CONDUCTORS, Conductors as specified in Sub-clause, POTENTIAL EQUALIZATION CONDUCTORS ,Functional earth conductorsN/Ad)Conductors in power supply cords intended to be connected to the neutral conductor of the supply system shall be coloured “light blue” as specified in IEC Publication 227 (Amendment No. 1) or in IEC Publication 245.N/Ae)Colours of conductors in power supply cords shall be in accordance with IEC Publication 227(Amendment No. 1) or with IEC Publication 245 N/Af)Where a multi-conductor cord is used between equipment parts and the maximum allowed resistance of the protective earth connection would be exceeded if only the green and yellow coloured conductor were used, other conductors of the same cord may be connected in parallel with the green and yellow conductor, provided that the ends of such additional conductors are marked green and yellow.No protective earth.N/A6.6Identification of medical gas cylinders and connectionsNo medical gas cylinders.N/AIn accordance with ISO ISO/R 32N/A6.7Indicator lights and push-buttonsThe indicator lights and push-buttons is used N/Aa)Red indicator lights used exclusively to indicate a warning of danger and/or a need for urgent actionNo red color used.N/A- Yellow used to indicate caution or attention requiredNo yellow color used.N/A- Green used to indicate ready for actionN/Ab)Color red used only for push-buttons by which a function is interrupted in case of emergencyNo red button.N/A6.8ACCOMPANYING DOCUMENTS6.8.1Equipment accompanied by documents containing at least instructions for use, a technical description and an address to which the user can referSee User Manual for details.PassClassifications specified in Clause 5 included in both the instructions for use and the technical descriptionSee User Manual for details.PassMarkings specified in Sub-clause 6.1 included in the accompanying documents if they have not been permanently affixed to equipmentPassWarning statements and the explanation of warning symbols provided in the accompanying documentsSee User Manual for details.Pass6.8.2Instructions for usePass6.8.2aGeneral information provided in instructions for useSee User Manual for details.Pass- state the function and intended application of the equipmentSee User Manual for details.Pass- include an explanation of: the function of controls, displays and signalsSee User Manual for details.Pass- the sequence of operationSee User Manual for details.Pass- the connection and disconnection of detachable parts and accessoriesSee User Manual for details.Pass- the replacement of material which is consumed during operationN/A- information regarding potential electromagnetic or other interference and advice regarding avoidanceN/A- include: indications of recognized accessories, detachable parts and materials, if the use of other parts or materials can degrade minimum safetyN/A- instructions concerning cleaning, preventive inspection and maintenance to be performed including the frequency of such maintenanceSee User Manual for details.PassGeneral information provided in instructions:Pass- information for the safe performance of routine maintenanceN/A- parts on which preventive inspection and maintenance shall be performed by other persons including the periods to be appliedN/A- explanation of figures, symbols, warning statements and abbreviations on the equipmentSee User Manual for details.Pass6.8.2cSignal output or signal input parts intended only for connection to specified equipment describedSee User Manual for details.Pass6.8.2dDetails about acceptable cleaning, disinfection or sterilization methods includedSee User Manual for details.Pass6.8.2eWarning statement for mains operated equipment with additional power sourceN/A6.8.2fA warning to remove primary batteries if equipment is not likely to be used for some timeSee User Manual for details.Pass6.8.2gInstructions to ensure safe use and adequate maintenance of rechargeable batteriesN/A6.8.2hIdentification of specified external power supplies or battery chargers necessary to ensure compliance with the requirements of IEC 601-1N/A6.8.2jIdentification of any risks associated with the disposal of waste products, residues, etc.See User Manual for details.Pass- Advice in minimizing these risksSee User Manual for details.Pass6.8.3Technical descriptionPass6.8.3aAll characteristics essential for safe operation providedSee User Manual for details.Pass6.8.3bRequired type and rating of fuses utilized in the mains supply circuit external to permanently installed equipmentN/A- Instructions for replacement of interchangeable and/or detachable parts which are subject to deterioration during normal useNo fuse information needed due to board replacement in case of fuse opened.N/A6.8.3cInstructions or reference information for repair of equipment parts designated by the manufacturer as repairable providedNo operator repairable parts.N/A6.8.3dEnvironmental conditions for transport and storage specified in accompanying documents and marked on packagingStorage Environment :Temperature: -20+65 Humidity: 1095% RH Working Environment:Temperature: +5+40 Humidity: 1090% RHPass7Power inputPassThe steady state current or power input of equipment at rated voltage, steady state operating temperature, and at operational settings specified by the manufacturer shall not exceed the marked ratingas required by Sub-clause 6.1 j) by more than:See Table 7.Passa)for equipment with a power input mainly caused by electric motor drive(s):+ 25 % for a RATED input power up to and including 100 W or 100 VA;+ 15 % for a RATED input power over 100 W or 100 VA;N/Ab)for other equipment:+ 15 % for a RATED input power up to and including 100 W or 100 VA;+ 10 % for a RATED input power over 100 W or 100 VA.Not applicableN/A8Basic safety categoriesN/AThe content of Clause 8 of the first edition has now been transferred to Appendix A.1.1See the clause A.1.1N/A9Removable protective meansN/ANot usedN/A 10Environmental conditionsPass10.1Equipment is capable while packed for transport or storage of being exposed to the conditions stated by the manufacturerStorage Environment :Temperature: -20+65 Humidity: 1095% RH Working Environment:Temperature: +5+40 Humidity: 1090% RHPass10.2.2aRated voltage not exceeding 250 V for hand-held equipment3 VdcPassRated voltage not exceeding 250 V d.c. or single-phase a.c. or 500 V polyphase a.c. for equipment up to 4kVAN/ARated voltage not exceeding 500 V for all other equipmentN/ARated input frequency not more than 1kHzDCN/A10.2.2bInternal replaceable electrical power source specifiedAAA size dry batteryPass11Not used.N/A12Not used. Transferred to Sub-clause 3.6N/A13Protection against electric shock hazardsPassGeneral: Equipment shall be so designed that the risk of electric shock in NORMAL USE and in SINGLE FAULTCONDITION is obviated as far as practicable Pass14Requirements related to classificationN/A14.1CLASS I EQUIPMENTInternally powered equipment.N/A14.2CLASS II EQUIPMENT shall be one of the following types:Internally powered equipment.N/Aa)1) insulation-enclosed CLASS II EQUIPMENT:N/A2) metal-enclosed CLASS II EQUIPMENTN/A3) EQUIPMENT which is a combination of types 1) and 2) aboveN/Ab)If the isolation of the MAINS PART from ACCESSIBLE M