Page 1 of 24 ‘emus ea ta IEC 60601-1 Medical electrical equipment Part 1; General requirements for basic safety and essential performance 64,667. 17.084.02 2017.08.03, Amendment No. 1: 2018-01-23 24 Report Reference No.. Date of issue Total number of pages .. TUV SUD Certification and Testing (China) Co., Ltd. Guangzhou Branch Testing Laboratory .. Address, 5F, Communication Building 163 Pingyun Rd, Huangpu Ave. West 510656 Guangzhou CHINA Applicant's name... Address... ‘Guangdong Horigen Mother&Baby Products Co., Ltd No.8, Yi Road, Pingbei Industrial Zone, Chaoyang District, Shantou, Guangdong, China. Test specification: Standard IEC 60601-1:2008 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A:2012 (or IEC 60601-1: 2012 reprint Test procedure Voluntary test Non-standard test method... None Test Report Form No. 1EC60601_1K Test Report Form Originator nw.i UL(US) Master TRF 2016-11 Copyright © 2015 Worldwide System for Conformity Testing and Certification of Electrotechnical Equipment and Components (IECEE), Geneva, Switzerland. All rights reserved. “This publication may be reproduced in whole or in par for non-commercial purposes as lng as the IECEE fs acknowledged as Copyright over and soures ofthe materia, IECEE takes no responsiblity for and will not assume Fablily for damages resuling from the teaders interpretation ofthe reproduced matorial due tos placement and context If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo and the reference to the CB ‘Scheme procedure shall be removed. This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02. General disclaimer: ‘The test 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 Issuing CB testing laboratory, The authenticity of this Test Report and its contents can be verified by contacting the NCB, responsible for this Test ReportPage 2 0f 24 Report No.: 64,667. 17,064.02 ‘Test item description. Electric Breast Pump HORIGEN ‘Guangdong Horigen Mother&Baby Products Co., Ltd. XN-22198M1, XN-2219M2, XN-2223N1, XN-2223M2, XN-2233M1,, XN-22330M2, XN-2212M2 For XN-2219M1, XN-2219M2, XN-2223M1, XN-22231M2, XN- 2242M2 ‘Adapter input: 100-240V~ 5O/60Hz 0.35A ‘Adaptor output: 10VDC, 1.58 Internally powered:7.4V de For XN-2233M1, XN-2233M2 | Adapter input: 100-240V~ 50/60Hz 0.2A ‘Adaptor output: VDC, 1A Internally powered: 6V de Model/Type reference. Ratings sun Testing procedure and testing location: Ea [Testing Laboratory: Testing location! address TOV SUD Certification and Testing (China) Co., Ltd, Guangzhou Branch / 5F, Communication Building 163, Pingyun Rd, Huangpu Ave. West 510656 Guangzhou CHINA Gi [Associated Testing Laboratory: ‘Testing location! address ‘Tested by (name, function, signature).......: | Zack Shen |Approved by (name, function, signature)...: ||van Ding i |Testing procedure: CTF Stage 1: Testing location’ address Tested by (name, function, signature [Approved by (name, function, signature) .: 1 [Testing procedure: CTF Stage 2: Testing location’ address ... Tested by (name, function, signature).. Witnessed by (name, function, signature) .: Approved by (name, function, signature)...: Testing procedure: CTF Stage 3: Qo O | Testing procedure: CTF Stage 4: TRF No. IEC60601_1K ©Page 3 of 24 Report No.: 64.66T.17.064.02 ‘Testing location! address Tested by (name, function, signature) Witnessed by (name, function, signature) Approved by (name, function, signature Supervised by (name, function, signature) : ‘TRF No. |EC60601_1KPage 4 of 24 Report No.: 64.667. 17.064.02 List of Attachments (including a total number of pages in each attachment): Attachment 1: This Amendment Report, Ref. No. 64.667.17.064.02 to the original Report Ref. No. 64.667.17.064.01 contains 24 Report Pages and 5 Pages of national difference. ‘Summary of testing Tests performed (namo of test and test clause): Testing location: Clause 4.11 power input TOV SUD Certification and Testing (China) Co., Ltd. Clause 11.1 PROTECTION AGAINST EXCESSIVE Guangzhou Branch, SF, TEMPERATURES AND OTHER HAZARDS Communication Building 163 Clause 13.1 HAZARDOUS SITUATIONS AND FAULT CONDITIONS Pingyun Rd, Huangpu Ave. West 510656 Guangzhou ‘Summary of compliance with National Differences | List of countries addressed: USA TRF No, IEC60601_1KPage 6 of 24 Report No.: 64.66T.17.064.02 Copy of marking plate Original report Ref, 64.667.17.064.04, dated 2017-08-03, ‘TRF No. 1EC80601_1KPage 6 of 24 Report No.: 64.667. 17,064.02 GENERAL INFORMATION Test item particulars (see also Clause 6): Classification of installation and use. Device type (component/sub-assembly/ equipment/ system) Intended use (Including type of patient, application location) : Mode of operation ‘Supply connection 7 Accessories and detachable parts included Other options include. Portable Equipment Mimic baby's sucking action and pump breast milk Continuous Internally powered / Direct plug-in See "General remark" underneath ‘See "General remark’ underneath Testing Date of receipt of test item(s)... 2017.06.29 Dates tests performed 2018.01.03 to 2018.01.19 Possible test case verdicts: - test case does not apply to the test object - test object does meet the requirement. - test object was not evaluated for the requirement. = test object does not meet the requirement. NA Pass (P) [NE (collateral standards only) Fail (F) Abbreviations used in the report: = normal condition .. = NC. = means of Operator protection ..., MooP single fault condition... SFC. means of Patient protection ....: MOPP TRF No, IEC60601_1KPage 7 of 24 Report No.: 64.667.17.064.02 General romarks: Before starting (o use the TRF please read carefully the 4 instructions pages at the end of the report ‘on how to complete the new version “J” of TRF for IEG for 60601-1 3° edition with Amendment 1. "(See Attachment i) refers to additional information appended to the report. "(See appended table)" refers to a table appended to the report. The tests results presented inthis report relate only to the object tested. This report shall not be reproduced except in full without the written approval ofthe testing laboratory. List of fest equipment must be kept on fle and available for review. Additional test data andlor information provided in the attachments to this repor. ‘Throughout this report a [] comma / [Z] point is used as the decimal separator. ‘The Medical Electrical Equipment consists of the following components and accessories: * AC/DC Adapter The following components and accessories were part of the present evaluation © AC/DC Adapter The following components and accessories were used in order to perform the testing but were not be part of the present evaluation: © None In addition, the compliance of the Medical Electrical System with clause 16 of this standard was tested in combination with the following devices: © None Risk management file: The RMF has been evaluated according plausibilty and technical consistency based on respective requirements out of ISO 14971. The risk acceptance criteria have been set by the manufacturer. Manufacturer's Declaration per sub-clause 4.2.6 of IECEE 02:2012 The application for obtaining a CB Test Certificate O yes includes more than one faciory location and a declaration from the Manufacturer stating that the Not applicable ssample(s) submitted for evaluation i (ere) representative ofthe products from each factory has been provided . When differences exist; they shall he identified in the General product information section. ‘Same as manufacturer | Name and address of factory (ies) TRF No. IEC60601_1K ©Page 8 of 24 Report No.: 64.667.17.084.02 General product information: The electric breast pump is intended to mimic baby's sucking action and pump breast milk. All the models can be powered by external adapter or internal battery. Model XN-2219MI1, XN-2219M2, XN-2223M1, XN- 2223M2 and XN-2212M2 have internal rechargeable ithium baltery and can be poweredicharged by external ‘adapter (model GEO181UB-1015 for US plug/ model GEO151T-1015 for EU). Model XN-2233M1 and XN- 2233M1 can be powered by AA battery and external adapter (model GEO061U-0610 for US/ model GEOOS1T- (0610 for EU), Difference among models are shown below: XN- XN- XN XN XN XN XN zoiomi_| 22t9ma_| 222am1_| 2023m2_| 2233m1 | 2233Ma_| 22t2Ma Grtical | Same | Same | Same |Same [Same | Same —_| Same componen t PoB Same, similar to other | Same, similarto other | Same, similar to other | Similar to LavouT/ | models. models, models, other Gitcal | Use 10V adapter input, | Use 10V adapter input, | Use 6V adapter input, Ged o with power control with power control ‘without power control Use 10V circuit (10V-6V) circu (10V-6V) circuit (no 10V-8V adapter contro circ input, with power control circuit (iov-6v) Output | 4 2 1 2 1 2 2 ne Sway saway S.way output output output Pump | 1 1 1 1 ya 2 number ‘Amendment 4 report: ‘This report is only valid with the original report Ref. 64.66T.17.064.01, dated 2017-08-03. This report adds the following items: 1.Add national difference of USA, 2.Add test of sub-clause 4.11, 11.1 and 13 on model XN-2233M2. 3.In clause of 7.3.3, replace the comment "No lithium battery used” with the following: “No lithium battery used on model XN-2233N1 and XN-2233M2. Lithium battery used on model XN- 2219M1, XN-2219M2, XN-2223M1, XN-2223M2 and XN-2212M2". 4.1n the appendix table of 11.1.1, replace the measuring position “Breast Shield body" with “Breast Shield’, and revise the battery's allowable temperature to "85°C". ‘TRF No. 1EC60601_1KPage 9 of 24 Report No. 64,667 17,064.02 IEC 60801-1 Clause Requirement + Test _ Result - Remark Verdict INSULATION DIAGRAM , ; ee av me aera Applied part \ ‘TRF No. IEC60601_1K Plastic enclosure E Hi Conduit oc74 ‘Type OF x ‘Applied part 8 Plastic enclosurePage 10 of 24 Report No.: 64.667. 17.084.02 TEC 60601-1 Clause [Requirement + Test Result - Remark Verdict -TABLE: INSULATION DIAGRAM P Pollution degree... 2 = ‘Overvoltage category. [Adaptor power mode: It = Internal battery mode: no overvoltage category <2000m = Additional details on parts considered | DX None [_] Areas = as applied parts... (See Clause 4.6 for details) Numberand | CT | Working voltage | Required | Required | Measured] Measured ‘area | tvbe of Means: ereepage | clearance] creepage cee of Protection: Vow Jo Va) emmy | fmm) | (mm) | (mm) MOOP, MOP. A amoop — |i |ac240 |339 [5.0 40 |- - L,Nto the accessible DC output of adapter. Approved ‘adapter used. See appended table 8.10 for etail B |2moop — fill. |DC 10 10 10 [34 3.1 | From internal circuit to enclosure through the gap of enclosure, c |2mopp = ji Jocto |- [3.4 16 |>>40 |>>10 | Secondary Circuit to ‘applied part trough tubing. pb |1mopp = ib |ac250 354 [40 = |25—|>>t0.|>>40—_| Secondary circuit to applied part through tubing e |2mopp fii |Ac2ao 339 Jao 50 |= - LNto applied part. This insulation is provided by insulation Ax. ‘TRF No, |EC60601_1K 9Page 11 of 24 Report No.: 64.667. 17.084.02 TEC 60601-1 | Clause _ | Requirement + Test Result - Remark Verdict F |1mopp — ii. Jac240 |309 28 20 |~ - Opposite polarity between L to Nof the primary circuit before fuse. Approved adapter used. G |2moop — fit. joc 72 |-- 10 10 14 14 From internal circuit to enclosure through the gap of enclosure, H |2MoPR Ib Joo72 |~ 34 16 eto j>>t0 | Secondary circuit to applied part through tubing. 1MOPP Ib Jac250 364 40 25 peta [>>10 | Secondary ‘circuit to applied part through ‘tubing, ‘Supplementary Information: INSULATION DIAGRAM CONVENTIONS and GUIDANCE: ‘Ameasured 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 under ‘evaluation 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 and protective 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 separate transformer windings, 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 an arrow. ‘TRF No, IEC60601_1K @Page 12 of 24 Report No.: 64.667. 17.064.02 TEC 60604-1 Clause [Requirement + Test [Resut- Remark Vert ie ME EQUIPMENT IDENTIFICATION, MARKING, AND DOCUMENTS P 73 Marking on the inside of WE EQUIPMENT oF ME EQUIPMENT parts P| [7.34 [Maximum power loading of heating elements or [No heating element NA lamp-holders designed for use with heating lamps marked near or in the heater (W).. ’A marking roferting to ACCOMPANYING DOCUMENTS NIA provided for heating elements or lamp-holders Gesigned for heating lamps that can be changed only by SERVICE PERSONNEL using @ Toot 73.2 | Symbol24 of Table D.1, or safety sign No.3 of | No high voltage part wa Table D.2 used to mark presence of HisH VOLTAGE parts. 7.3.3 | Type of battery and mode of insertion marked: P ‘An identifying marking provided referring to |Marked in battery container | P instructions in accoMPaNYING DocUMENTS for batteries intended to be changed only by | SERVICE PERSONNEL Using a TOOL ss ‘A waming provided indicating replacement of | No lthium battery used on P lithium batteries or fuel cells when Incorrect |model XN-2233M1 and XN- replacement would result in an unacceptable |2233M2. Lithium battery used ws fon model XN-2219111, XN- 221902, XN-222301, XN- 2223M2 and XN-2212M2 RISK MANAGEMENT FILE Includes an assessment [No lhium battery used on P {to determine the replacement of lithium model XN-2233MM1 and XN- batteries or uel cells leads to an unacceptable |2233M2. Lithium battery used sk if replaced incorrectly oon model XN-2219M1, XN- 2241982, XN-2223MI1, XN- |('80 14974 Cl 42-44, 5,6.3) Se ae eua ACCOMPANYING DOCUNENTS contain a warning | No lithium battery used on P indicating the replacement of lithium batteries. |model XN-2233M1 and XN- or fuel cells by inadequately trained personnel |2233M2, Lithium battery used Could result in a HAZARD. ‘at [on model XN-2219M1, XN- 2219M2, XN-2223M1, XN- 22232’ and XN-2212M2 734 | Fuses, replaceable THERMAL CUT-OUTS and ovER- |No such replaceable NIA CURRENT RELEASES, accessible by use of a T001._ | components Identified : Voltage (V) and Current (A) rating. : [See above = Operating speed(s), size & breaking capacity. : |See above = 73.5 | PROTECTIVE EARTH TERWINAL marked with symbol NIA 6 of Table D.1 TRF No. 1EC60601_1Kc {Clause Page 13 of 24 IEC 60801-1 [Reaurerent Tes Report No.: 64.66T.17.064.02 Result - Remark Verdict Markings on or adjacent to PROTECTIVE EARTH ‘TERMINALS not applied to parts requiring removal to make the connection, and remained visible after connection made NA 736 ‘Symbol 7 of Table D.1 marked on FUNCTIONAL EARTH TERMINALS No functional earth terminal NIA 737 [Terminals for supply conductors marked | adjacent to terminals... Terminals for supply connections are not marked, the RISK MANAGEMENT FILE includes an assessment of the Risks resulting from misconnections.. (10 14971 C1. 4.3) No such supply conductor See above ‘Terminal markings included in ACCOMPANYING DOCUMENTS when ME EQUIPMENT too small to accommodate markings NA NIA NA Terminals exclusively for neutral supply conductor in PERMANENTLY INSTALLED ME EQUIPMENT marked with Code 1 of Table D.3 NA for connection to a 3-phase supply, complies with IEC 60445 NA Markings on or adjacent to electrical connection points not applied to parts requiring moval to make connection, and remained visible after connection made NA 738 “For supply connections, use wiring materials suitable for at least X °C” or equivalent, marked at the point of supply connections No such wiring material used. NIA ‘Statement not applied to parts requiring removal to make the connection, and CLEARLY LEGIBLE after connections made NIA " HAZARDS. PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER WA jataa Excessive temperatures in ME EQUIPMENT ‘Temperatures on ME EQUIPMENT parts did not exceed values in Tables 22 and.. : ‘See appended Table 11.1.1 Surfaces of test comer did not exceed 90 °C. THERMAL CUT-OUTS did not operate in NORMAL conoition RISK MANAGEMENT FILE Includes an assessment |of the duration of contact for all APPLIED PARTS and ACCESSIBLE PARTS. (ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5) Risk management report: lem 2 (ISO 14971 Cl, 42-44, 6, 6.2- 6.3) M42 Temperature of APPLIED PARTS TRF No. IEC60601_1kPage 14 of 24 IEC 60601-1 Report No.: 64,667. 17,084.02 {Clause Requirement + Test Result - Remark Verdict [taza APPLIED PARTS (hot or cold intended to supply heat fo a PATIENT comply [Applied part not intended to supply heat to patient NIA ied and documented in the RISK MANAGEMENT FILE (180 14971 Cl. 4.2-4.4, 5, 6.2-6.5) See above NA Temperature (hot or cold) of APPLIED PARTS Intended to supply heat to a PATIENT disclosed, in the instructions for use NIA WA22 |APPLIED PARTS not intended to supply heat to a PATIENT complies with the limits of Table 24 in NORMAL CONDITION and SINGLE FAULT CONDITION. APPLIED PARTS Surface temperature exceeds /41°C disclosed in the instruction manu: No more than 41°C Maxi um Temperature. NA Conditions for safe contact, 0.g. duration or condition of the PATIEN} NA Clinical effects with respect to characteristics {taken or surface pressure documented in the RISK MANAGEMENT FILE. (180 14971 Cl, 4.2-4.4, 5, 6.2-6.5) APPLIED PARTS surface temperature of equal to or less than 41°C Analysis documented in the RISK MANAGEMENT FILE show that APPLIED PART temperatures are not affected by operation of the ME EQUIPMENT including SINGLE FAULT CONDITIONS. Measurement of APPLIED PART temperature according to 11.1.3 is not conducted.. No such analysis. Test performed. NIA ‘Surfaces of APPLIED PARTS that are cooled below ambient temperatures evaluated in the RISK MANAGEMENT PROCESS.. i 5) No ‘such applied part. NA 14.3 (180 14974 Cl. 4.2-4.4, 8, 6: ‘Measuroments not made when engineering judgment and rationale by MANUFACTURER indicated temperature limits could not exceed, as documented in RISK MANAGEMENT FILE. (180 14974 Cl. 4.2-4.4, 5, 6.2-6.5) Test performed, no such judgment NIA ‘Test corner not used where engineering judgment and rationale by MANUFACTURER indicated test corner will not impact measurements, as documented in Risk MANAGEMENT FILE {ISO 14974 Cl. 4.2-4.4, 5, 6.2-6.5) ‘TRF No, IEC60601_1K Test performed, no such judgment NIAPage 15 of 24 Report No.: 64.667. 17,084.02 IEC 60601-1 Clause | Requirement + Test Result - Remark Verdot Probability of occurrence and duration of Risk management report P contact for parts likely to be touched and for iam > 3 APPLIED PARTS documented in RISK MANAGEMENT (ISO 14971 Cl. 4.2-4.4, 5, 6.2- FILE. (180 14971 Cl. 4.2-4.4, 5, 6.2-6.5) 6.4) e) Where thermal regulatory devices make this | Not such device, NA method inappropriate, alternative methods for measurement aro justified in the RISK MANAGEMENT FILE : 41.1.4 |GuARDS preventing contact with hot or cold | No such guards, NIA accessible surfaces removable only with a ‘Too. 8 HAZARDOUS SITUATIONS AND FAULT CONDITIONS 43.4 Specific HAZARDOUS SITUATIONS. 43.1.2 |Emissions, deformation of ENCLOSURE or exceeding maximum temperature 2\v|vlo — Emission of flames, molten metal, poisonous or ignitablo substance in hazardous quantities did not occur — Deformation of encLosure impairing P compliance with 15.3.1 did not occur = Temperatures of APPLIED PARTS did not exceed | See appended Table 11.1.1 Pp allowable values in Table 24. = Temperatures of me EQUIPMENT parts that are | See appended Table 11.1.1 Pp Not APPLIED PARTS likely to be touched did not exceed values in Table 23 Allowable values for “other components and Pp materials” in Table 22 times 1.5 minus 12.6 °C ]were not exceeded Limits for windings in Tables 26, 27, and 31 not P exceeded Table 22 not exceeded in all other cases After tests of this Clause, settings of tHermat. |See appended Table 13.1.2 Pp ‘CUT-OUTS and OVER-CURRENT RELEASES did not change sufficiently to affect their safety function 13.4.3 in SINGLE FAULT | See appended Table 87 P {foF LEAKAGE CURREN! CONDITION did not exceed = voltage limits for ACCESSIBLE PARTS including |See appended Table 6.7 P APPLIED PARTS did not exceed fcr 13.2__| SINGLE FAULT CONDITIONS During the application of the SINGLE FAULT Pp CONDITIONS listed in 13.2.2 to 13.2.13 (inclusive), the NORMAL CONDITIONS identified in 8.1 a) also applied in the least favourable combination TRF No, IEC60601_1K ®Page 16 of 24 Report No.” 64.667. 17,064.02 IEC 60601-1 Gece [Rosuerent+ Tost [Rout Remark Vet VE COUP MENT compiled with 1822-41822 ni [See appended Tabe 102 | _P TS MANAGENENT iE ncludes and assessment |No uid intended tobe used | WA of risks associated with leakage of liquid in a | with equipment. | SINGLE FAULT CONDITION. nu | | (ISO 14971 Cl. 4.2-4.4, 5, 6.2-6.5) | RISK MANAGEMENT FILE defines the appropriate | See above. NIA test conditions.. 13.2.13 | Me EQUIPMENT remained safe after tests of NA 13.2.13.2 to 13.2.13.4, and cooling down to | within 3 °C of test environment temperature | Me EquiemeNT examined for compliance or NIA appropriate tests such as dielectric strength of motor insulation according to 8.8.3 conducted For insulation of thermoplastic materials relied NA upon as a MEANS OF PROTECTION, the ball- pressure test specifiod in 8.8.4.1 a) performed at a temperature 25 °C higher than temperature of insulation measured during tests of 13.2.13.2 to 13.2.13.4 (inclusive). 13.2.43.2_ | Me cquipment with heating elements NA a1) thermostatically controlled me EQUIPMENT NIA with heating elements for building-in, r for |unattended operation, or with a capacitor not protected by a fuse connected in parallel with [THERMOSTAT contacts met tests a 2) me EQUIPMENT with heating elements RATED NA for non-cONTINUOUS OPERATION met tests | 3) other me EQUIPMENT with heating elements. na | met test | When more than one test was applicable to NIA ‘same ME EQUIPMENT, tests performed } consecutively Heating period stopped when a heating NA element or an intentionally weak part of a non- SELF-RESETTING THERMAL CUT-OUT ruptured, or current interrupted before THERMAL STABILITY without possibility of automatic restoration Test repeated on a second sample when NIA interruption was due to rupture of a heating |element or an intentionally weak part Both samples met 13.1.2, and open circuiting wa | ‘of a heating olement or an intentionally weak in second sample not considered a failure | olf TRF No, IEC80601_1KPage 17 of 24 EC 60601-1 Report No.: 64.66T.17.064.02 Clause Requirement + Test Result - Remark Verdict b) Me Equipment with heating elements without adequate heat discharge, and supply voltage set at 90 or 110 % of RATED supply voltage, least favourable of the two (V) No heating element. NA Operating period stopped when a non-sELF- RESETTING THERMAL CUT-OUT operated, or current interrupted without possibility of automatic restoration before THERMAL STABILITY Me EQUIPMENT switched off as soon as THERMAL [STABILITY established and allowed to cool to. room temperature when current not interrupted NIA NIA ‘Test duration was equal to RATED operating time for non-CONTINUOUS OPERATION (c) Heating parts of mE Equipment tested with me EQUIPMENT Operated in NORMAL CONDITION at 110 % of RATED supply voltage and as in 11.1, and NA NA 1 |4) Controls limiting temperature in NORMAL. | CONDITION disabled, except THERMAL CUT-OUTS |2) When more than one control provided, they |were disabled in turn NA NIA | 3) Me EquipmeNT operated at RATED DUTY CYCLE | until THERMAL STABILITY achieved, regardless of | RATED operating time NA 13.2.13.3 Me cuipment with motors a1) 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, as applicable To determine compliance with 13.2.9 and 13.2.0 motors in circuits running at 42.4 V peak a.c./ 60 V d.c. or less are covered with a single layer of cheesecloth which did not ignite during the test NA 22) Tests on ME EQUIPMENT containing heating parts conducted at prescribed voltage with motor & heating parts operated simultaneously to produce the least favourable condition No heating part NIA /a 3) Tests performed consecutively when more tests were applicable to the same ME EQUIPMENT b) Motor met running overload protection test of this clause when: NA 4) it is intended to be remotely or automatically controlled by a single control device with no redundant protection, or Not intended to be remotely or automatically controlled, NA 2) itis likely to be subjected to continuous [OPERATION while unattended Not subjected to continuous operation while unattended, NA ‘TRF No. IEC60601_1KPage 18 of 24 Report No.: 64.65T.17.064.02 IEC 60601-1 [Clause [Requirement + Test Result - Remark | Verdict ‘Motor winding temperature determined during |N/A NA each steady period and maximum value did not exceed Table 27 (Insulation Class, Maximum temperature measured °C).. Motor removed from me EQUIPMENT and tested NA |separately when load could not be changed in appropriate steps Running overload test for motors operating at NA 42.4 V peak a.c./60 V d.c. or less performed ‘only when examination and review of design indicated possibility of an overload ‘Test not conducted where electronic drive | - NIA circuits maintained a substantially constant |drive current Test not conducted based on other NIA NA justifications (justification). ¢) Me Equipment with 3-phase motors operated with normal load, connected to a 3-phase SUPPLY MAINS with one phase disconnected, and periods of operation per 13.2.10 | 13.2.13.4 | Me EQUIPMENT RATED for NON-CONTINUOUS OPERATION NA NA | Me Equipment (other than HAND-HELD) operated | Continuous operation wa | under normal load and at RATED voltage or at | upper limit of RATED voltage range until increase in temperature was <5 °C in one hour, | ‘or a protective device operated ‘When a load-reducing device operated in NA NORMAL USE, test continued with me EQUIPMENT running idle ‘Motor winding temperatures did not exceed —_| Continuous operation NA values in 13.2.10.. : NA = [wa = Insulation Class.. | Maximum temperature measured (°C)... TRF No, IEC60601_1KPage 19 of 24 Report No.: 64.667.17.064.02 IEC 60601-1 [Gieuse [Reautemont «Test [Resa Remark Verdi lana [TABLE: Power Input : Pp Operating Conditions /Ratings | Voge | Freeney | Curent | Pawar | Powe Normal operating with the highest vacuum 90 50 749 3.69 0.57 Pode 29910 to | so | 037 | 362 (05 2a0 50 385 362 [oat 264 50 349 3.34 [0.40 90 60 72.4 350 (0.55 100 60 38 333 [058 240 60 370 360 [040 264 00 350 3a7__ [039 Normal operating wih the highest vacuum | 80 0 750 373 ‘(oss Maal snc azsoM ae 109 80 68.0 359 [oa 240 50 377 3.63 J0.44 264 50 34.9 3.58 J0.39 30 6 735 388 [oss 700 80 964 350 [oss 240 30 383 358 [ose 264 60 36.6 3.59 |0.39 Supplementary Information: 414 |TABLE: Excessive temperatures in ME EQUPMENT [Pe Mode! No. XN-2212M2 XN-2223M2_ XN- 2233M2 Test ambient (°C) . 28.5°C 127.6°C /27.9°C | 28.5°C /27.6°C /27.9°C | 26.3°C | 15.0% (126.6°C Test supply voltage/frequency (ViHz)")..:| 90V 50Hz/ 264V S0Hz/ | 90V SOHz/ 264V 50Hz! | 90V SOHz! Internally powered | Internally powered | 264V 50H2/ | Internally _ _ _ powered ax mossure Thermo ese | anni ro) oe No. Mode! No. | couple | Thermocouple location” | y3be 09 23 of 24 or RM file for AP®) (°C) 90 284 BT ‘TRF No. |EC60601_1K ®Page 20 of 24 Report No.: 64.667.17.064.02 - IEC 60601-4 [Clause [Requirement + Test Result Remark Verdict XN- 102” [Test comer 902 40.5 | 404 [406] Testresult 2212M2 adjusted to ambient 40°C 703 [Plastic enclosure of 71 65.9 | 658 | - adaptor 206 | Display Screen 7 496 | 49.1 | 47.0 201 [Air pump 959 739 | 743 [71.3 202 | Solenoid valve 1209 979 | 98.0 [957 205 | Button m 52.1 | 61.9 | 47.2 204 [Plastic enclosure of 859 493 | 60.1 |493 ‘main unit 320 [Main unit's PCB board 1309 603 | 698 |565 hear pump 203 [Battery 859) 522 | 53.0 |523 | 346 [Ut on PCB board 130) 731 | 789 | 643 317 |U20n PCB board 130) 61.6 | 620 | 556 318 {U4 on PCB board 130) 647 | 65.1 [576 319 |@2 on PCB board 7309 54.9 | 55.1 |53.0 207 | Breast Shield 436 409 | 407 |40.9 209 | Tubing m1 426 | 422 | 422 210 | Tubing connector nm 46.3 | 46.4 | 458 XN- 102 | Test comer’ 908) 40.5 | 40.4 | 40.6) : Testresult 2o3M2 | adjusted to ambient 40°C 104 [Plastic enclosure of 70 58.9 | 608 | - adaptor 312 _ | Display Sereen 74H 56.0 | 58.0 | 49.9 301 |Airpump 959 79.5 | 937 [732 302 [Solenoid vaive 120) 93.7 | 97.3 [93.3 31 [Button 719 40.4 | 49.8 [47.4 310 | Plastic enclosure of 859 59.4 | 616 | 560 main unit, 304 | Main unit's PCB board 1309 86.0 | 882 [606 near pump 305 [Battery 859 66.6 | 50.5 | 541 306 [Ut on PCB board 1309 655 | 682 | 592 307 [U2 on PCB board 1309 90.8 | 942 [602 308 [U4 on PCB board 1309 1178 | 1184 | 6.3 308 | G2 on PCB board “1309 776 | 804 [623 315 _ | Breast Shiela 436 407 | 40.5 | 408 314 | Tubing m0 448 | 443 |46.1 TRF No. IEC60601_1KPage 21 of 24 Report No.: 64.66T.17.064.02 IEC 60601-1 Clause [Requirement + Test Result - Remark 313 _ [Tubing connector 7m) 469 | 47.1 | 480 XN- 0105 | Test comer 902) 41.7 | 464 [405] Testresult 2233M2 adjusted to ambient 40°C 0103 | Plastic enclosure of mn 560 | 558] - adaptor 7 0008 [Display Screen 7m 48.9 | 48.1 | 48.0 (0002 [Air pump 959 62.4 | 612 [598 (0004 | Solenoid valve +1208 4.0 | 82.8 | 749 0006 | Button 7m 44.0 | 425 | 43.6 0010 | Plastic enclosure of 859) 478 | 46.4 | 43.0 ‘main unit 0009 | Main unit's PCB board 1309 632 | 620 [608 neat pump 107 [Battery 359 = | = [eas 007 |UT on PCB board 7309 776 | 766 [695 (0003 | Uon PCB board 1309 666 | 653 [628 (0005 |U4on PCB board 7307 56.5 | 55.2 [65.3 (0007 [G2 on PCB board 1309 582 | 56.9 [569 0107 | Breast Shield 430 403 | 402 | 40.0 0102 | Tubing m1 407 | 403 | 40.2 (0104 | Tubing connector m1 45.4 | 45.7 [45.4 ‘Supplementary information: + Maximum allowable temperature on surfaces of test comer is 90°C 2 Max temperature determined in acoordance with 111.36) “9 When thermocouples used to determine temperature of windings, limits of Table 22 reduced by 10 °C. 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 % ofthe minimum RATED voltage. 5) apeuteD PARTS intended to supply heat lo @ PATIENT -See RISK MANAGEMENT Fi Containing temperatures and clinical effects, Also, see instructions for use Information from Risk Management, as applicable: ‘Temperature limit according to table 23 27Temperature limit according clause 11.1.1 smTemperature limit according components certificate “STemperature limit according to table 24 STTemperature limit according to table 22 ‘TRF No. 1EC60601_1K ®Page 22 of 24 Report No.: 64,88T.17,064.02 IEC 0601-1 Clause [Requirement + Test Result - Remark Verdict 3.2 ‘TABLE: SINGLE FAULT CONDITIONS in accordance with 13.2.2 to 13.2.3, inclusive Pp Sic i Hazarvous ne Description of SINGLE FAULT CONDITION Results observed SITUATION : (YesiNo) 13.2.2. | Electrical SINGLE FAULT CONDITIONS per Cl. 8. = & Model XN-2212M2 U3 pin2-piné Unit normal operation Power input=0.20A/22WV to o.oBN7W Max. temp of: Battery=35.6°C Enclosure outside near battery=33.0°C Air pump=60.1°C Valve=81.9°C Enclosure outside near pump=41.3°C ‘Ambient=27.4°C UT pint-ping Unit shut down, No Power input:9.2WW/0.088A U4 pini-pins Unit normal operation, after No ‘1, display indicate "ES" Power input: 0.194/22Wmax- > 0.14A/13Wmax Max. temp of: Batlery=46.7°C Enclosure outside near battery=40.8°C Air pump=82.9°C Valve=131.5°C Enclosure outside near pump=61.0°C Ambient=27.6°C ‘Model XN-2233M2 Ut pin2-pin3 ‘Short circuit current=0.14A No Unit protected, but LED screen light up. Recoverable, Ua pint-pina Power input: 4.82Wmax, No 44.53mA max ‘motor continual operation, no hazard. Battery short circuit ‘Short circuit current=4.1A No Enclosure outside=96.5°C 43.2.3 | Overheating of transformers per Clause 15.5: = = TRF No, IEC60601_1KPage 23 of 24 Report No.: 64.667 17.064.02 IEC 60601-1 [Clause | Requirement + Test Result - Remark. [verdict _ Gai: |Hazaroous y Description of SINGLE FAULT CONDITION Results observed | SITUATION lo. (YesiNo) 13.2.4 | Failure of THERMOSTATS according to 13.2.13 & ss = | 15.4.2, overloading - THERMOSTATS short | circuited or interrupted, the less favourable of, the two: 13.2.5 | Failure of temperature limiting devices = = according to 13.2.13 & 15.4.2, overloading, THERMOSTATS short circuited or interrupted, the less favourable of the two: 13.2.6 | Leakage of liquid - Risk MANAGEMENT FILE = - examined to determine the appropriate test, conditions (sealed rechargeable batteries exempted) | 13.2.7 impairment of cooling that could result in a = = HazaRO using test method of 14.4: n fans locked conse Single ver ively | Ventilation openings on top and sides impaired by covering openings on top of ENCLOSURE or positioning of mE EquiPweNT against walls Simulated blocking of filters Flow of a cooling agent interrupted 13.2.8 | Locking of moving parts - Only one part locked = = ata time ~ Also see 13.2.10 bolow: Motor locked for § min Max. temp measured of: No ‘Ambient: 26.7°C Test voltage: 6V DC 13.2.9 | Interruption and short circuiting of motor = = capacitors ~ Motor capacitors short & open circuited *)~ Also see 13.10 'V measured = V measured = ‘TRF No. IEC60601_1KPage 24 of 24 Report No.: 64.66T.17.064.02 HazaRD (See 9 & 15.3): ___1EC 60601-1 7 [Clause [Requirement + Test Resull- Remark Verdict soe Hazanoous va Description of sINGLE FAULT CONDITION Results observed —_ | siTuariow : (YesiNo) 132.10 | Additional test criteria for motor operated me = 2 EQUIPMENT in 13.2.8 813.2.9: For every test in SINGLE FAULT CONDITION of 13.2.8 evpc No and 13.2.9, motor-operated EQUIPMENT stared from cOLD conorTion at RATED voltage or upper limit of ratED voltage range for specified timo: Tomporatures of windings determined at the 5 min No end of specified test periods or at the instant of operation of fuses, THERMAL CUT-OUTS, motor protective devices ‘Tomperatures measured as specified in 11.4.3 d) 70.9°C No Temperatures did not exceed limits of Table 26 150°C No 13.2.11 | Failures of components in Me EQUIPMENT used in = = conjunction with OXYGEN RICH ENVIRONMENTS: 13.212. | Failure of parts that might result in a MECHANICAL = = ‘Supplementary information: Test wth shert-cteuited capactor not performed when motor provided with a capacitor complying with IEC 60282-1 and the me [EQUIPMENT not intended fr unattended use including automatic or remote contra, See Aachment ¥ and appended Table 8.10, Information from Risk Management, as applicable: ‘TRF No. IEC60601_1kProduct Service TEST REPORT Deviations USA to IEC 60601-1: 2012 (PPP 48000A:2015) Medical electrical equipment Report reference no. 64,667.17.064.02 A Compiled by (* signature) Zack Shen Her Reviewed by (+ signature) Ivan Ding Dict BD Aditional information none Date of issue. 2018-01-23 Testing laboratory. TUV SUD PRODUCT SERVICE GmbH Munich, Germany Address. Ridlerstrasse 65, D-80339 Munich Testing location ‘TOV SUD PRODUCT SERVICE, Ridlerstrasse 65, D-80339 Munich Applicant Guangdong Horigen Mother&Baby Products Co., Ltd Address, No.8, Yi Road, Pingbe’ Industrial Zone, Chaoyang District, Shantou, Guangdong, China. Standard ‘This TUV SUD Product Service GmbH Test Report Form is based Test Report Form No. Master TRF. ‘on PPP 48000A:2015 Rev.2 and considers the following standards: Deviations between IEC 6060-1: 2012 and - ANSI/AAM] ES60601-1:2005/(R)2012 and A1:2012, €4:2009/(R)2012 and A2:2010/(R)20%2 (also referred to as ANSI/AAMI ES60601-1:2005/(R)2012) ‘TRF PPP 48000A:2015 Rev.2 TOV SUD PRODUCT SERVICE GmbH Test procedure Procedure deviation, Non-standard test method Voluntary test NA NA ‘Type of test object Trademark Modeliype reference. Electric Breast Pump XN-2219M1, XN-2219M2, XN-2223M1, XN-2223M2, XN-2233M1, XN-2233M2, XN-2212M2 Manufacturer. Address. Guangdong Horigen Mother&Baby Products Co., Ltd. No.8, Yi Road, Pingbei industrial Zone, Chaoyang District, Shantou, Guangdong, China. Test Report for Deviations USA / Canada to IEC 60601-1: 2012 (PPP 48000A:2015); Effective date: 02 Jun 2017; Rev. 2Rating sunat For XN-2219MM1, XN-2219M2, XN-2223M1, XN-2223M2, XN- 221aMa | ‘Adapter input: 100-240V~ 50/60H2 0.354 | ‘Adaptor output: 10VDC, 1.54 Internally powered:7.4V de For XN-2293M1, XN-2233M2 ‘Adapier input: 100-240V~ 50/60Hz 0.2A ‘Adaptor output: 6VDC, 1A | Internally powered: 6V de | Test Report for Deviations USA / Canada to IEC 60601-1: 2012 (PPP 48000A:2018);, Effective date: 02 Jun 2017; Rev. 2Report No. 64.667. 17.064.02 page 3 of § Prost Senieo ‘Sub-Ciause Difference + Test Remark Verdict 1005/(R)2012) United States — ANSI/AAMI ES60601-1:2005)(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (also referred to as ANSUAAMI ES60601. 4.8 b) [Replacement: ‘Where there is no relevant IEC/ISO standard, the relevant ANSI standard applies; if no relevant ANSI standard exists, the requirements of this standard is applied 440.2 Replacement: Rated voltage not exceeding 250V de or single phase ac. or 600V poly-phase ac for ME EQUIPMENT and ME SYSTEMS up to 4kVA Less than 250V Rated voltage not exceeding 600 V for all other ME EQUIPMENT and ME SYSTEMS NA Addition: The protective measures as described in IEC 60364-4-41 and the NEC NA 66 ‘Addition: To comply with NFPA 70, X-Ray systems are classified as long time operation (5 min) or momentary operation (< 5 sec) Not X-Ray system. NA 72.44 [Addition: To comply with NFPA 70, X-Ray systems are marked as long time operation or ‘momentary operation NA 7.2.22 To comply with NFPA 99: Cylinders containing ‘medical gases and their connection points are ‘colored in accordance with the requirements of NFPA 99 No such cylinders. NA 82 ‘Addition: All FIXED ME EQUIPMENT & PERMANENTLY INSTALLED ME EQUIPMENT are CLASS | ME EQUIPMENT Portable equipment. NIA® 86.1 Addition: To comply with NFPA 99, the enclosure of X-ray ME EQUIPMENT operating over 1600 Vac, 850Vde MAINS VOLTAGE, of containing voltages up to 50 V peak and enclosed in protectively earthed enclosure as well as ‘connections to X-ray tubes and other high ‘voltage components that include high voltage shielded cables are PROTECTIVELY EARTHED Not X-Ray system. NA To comply with NFPA 99, non-cutrent carrying conductive parts of X-Ray ME EQUIPMENT likely to become energized are PROTECTIVELY EARTHED NIA a7ad EARTH LEAKAGE CURRENT values are not higher than the stated values: =_5 MA in NORMAL CONDITION No earth connection. NA = 10 mA in SINGLE FAULT CONDITION NA att [Addition prior to the first paragraph: /a) To comply with the NEC, add the following requirements to this clause: ‘Test Report for Deviations USA / Canada to IEC 60601-1: 2012 (PPP 48000A:2015);, Effective date: 02 Jun 2017; Rev. 2 Tw?Report No. 64.667. 17.064.02 page 4 of & ‘Sub-Ciause Difference + Test Remark ‘Addition: PERMANENTLY CONNECTED ME EQUIPMENT provided with field wiring provision in accordance with NEC No such equipment Exception: Fixed and stationary X-ray ME EQUIPMENT supplied from a branch circuit rated at 30 Aor less NA ~ ME EQUIPMENT that is not strictly portable but obviously is intended to be stationary, may be acceptable if provided with a length of attached hard service flexible cord - such as Type S, or NA ~ the equivalent, for supply connection NA Installation of connecting cords between EQUIPMENT parts comply with NEC NA Cable used as external interconnection between units: 1) ifexposed to abuse the cable is of type SJT, SJTO, $JO, ST, SO, STO, or equivalent flexible cord or similar multiple-conductor appliance-wiring material NA 2) If not exposed to abuse, the cable is as indicated in item 1) above or: NIA i) type SPT-2, SP-2, or SPE-2, or equivalent NA il) type SVF, SVRO, SVE, or equivalent or similar multiple-conductor appliance wiring material, oF NA ili an assembly of insulated wires each with ‘nominal insulation thickness of 0.8 mm (1/32 inch) or more NA Receptacles provided as part of Me EQUIPMENT and Me SYSTEMS for use in the patient care areas of pediatric wards, rooms, or areas are listed tamper resistant or NA = employ a listed tamper resistant cover in accordance with NEC NA [Addition at the end of the clause: b) For Me EQUIPMENT provided with NEMA }configuration non-locking plug types 120 VI15 A, 125 VI20 A, 250 VI15 A, 250 VI20 A “Hospital [Grade mains plug is provided and the POWER [SUPPLY CORD is marked N/A B1132 Addition: The flexible cord is a type acceptable for the particular application, No such equipment N/A - and it is acceptable for use at a voltage not less than the rated voltage of the appliance NA ~ and has an ampacity as in NEC, not less than the current rating of the appliance NVA 811.33 ‘Addition: To comply with NFPA 99, for X-Ray ME EQUIPMENT with an attachment plug, the current NVA ‘Test Report for Deviations USA / Canada to IEC 60601 Effective date: 02 Jun 2017; Rev. 2 : 2012 (PPP 48000A:2015);Prac Sorico Report No. 64.667. 17,064.02 page 5 of 5 Sub-Ciause Difference + Test Remark, VWerelict rating on a hospital grade plug is 2X the maximum input current of the equipment ‘Test Report for Deviations USA / Canada to IEC 60601-1: 2012 (PPP 48000A:2015); Effective date: 02 Jun 2017; Rev. 2 Tov?