VERIFICATION STATEMENT EN :2006/ A1:2013+A12:2014 Part 1: General requirements for basic safety and essential performance

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1 Page 1 of 16 Report No SHA-001 VERIFICATION STATEMENT EN :2006/ A1:2013+A12:20 Part 1: General requirements for basic safety and essential performance Report Reference No.... : SHA-001 (based on CB certif. no. SE-85958) Tested by (+ signature)... : Larry Zhong... Approved by (+ signature)... : Justin Yu... Date of issue... : Contents... : 16 pages Testing laboratory Name... : Intertek Testing Services Shanghai Address... : Building 86, 1198 Qinzhou Road (North), Shanghai, China Testing location... : Same as above Client Name... : GlobTek, Inc. Address... : 186 Veterans Dr. Northvale, NJ USA Standard... : EN :2006/ A1:2013+A12:20 Test procedure... : S mark Non-standard test method... : N.A. Test item Description... : Medical Power supply Trademark... : GlobTek Model and/or type reference... : GT*91099-***-** GT*96600-***-** Rating(s)... : Input: 1.5A, V~, 50-60Hz; Manufacture... : GlobTek, Inc. Output: (Refer to Page 3 for output rating and variable definition) 186 Veterans Dr. Northvale, NJ USA Factory... : GlobTek (Suzhou) Co., Ltd Building 4, No. 76 JinLing East Road, Suzhou Industrial Park, Suzhou, JiangSu, , China Remarks for acceptance and review work conducted by above qualified testing laboratory Sample Number reviewed... : 1 pcs

2 Page 2 of 16 Report No SHA-001 Remark... : The product and the mentioned test reports comply with Swedish standard and nationals deviations, if any. The sample as shown in following page(s) is still corresponding with the one mentioned in CB test report. We concluded this statement verifies that above standards are fulfilled. Test item description... : No tests are needed for this product. Statement for deviations, if any... : National difference for Sweden has been evaluated in CB report.

3 Page 3 of 16 Report No SHA-001 Specification and key information involved in original CB certificate and test report Involved Ref. Certif. no... : SE Issued date... : Test item description... : Applicant's Name... : Address... : Manufacturer... : Factory... : Technical data... : Referred standard... : Model and/or type reference... : Involved test report... : Medical Power supply GlobTek, Inc. 186 Veterans Dr. Northvale, NJ USA GlobTek, Inc. 186 Veterans Dr. Northvale, NJ USA GlobTek (Suzhou) Co., Ltd Building 4, No. 76, Jin Ling East Rd., Suzhou Industrial Park, Suzhou, JiangSu , China Input: 1.5A, V~, 50-60Hz; Output: Refer to below for details. The product fulfils the requirements of : CORR. 1: CORR. 2: AM1:2012 & EN : A11: A1:2013 & ANSI/AAMI ES :2005/A1:2012 & CAN/CSA-C22.2 No :. GT*91099-***-** GT*96600-***-** SHA-001 GT*91099-***-** and GT*96600-***-** series The 1st * part can be M or - or H for market identification and not related to safety. The 2nd * denotes the rated output wattage designation, which can be 01 to 60, with interval of 1. When model= GT*91099-***-**, The 3rd * denotes the standard rated output voltage designation, which can be 09, 15, 24, 48 ; The 4th * is optional deviation, subtracted from standard output voltage, which can be to with interval of 0.01, or blank to indicate no voltage different. The 3rd * and 4th * together denote the output voltage, with a range of 5 48volts. When model=gt*96600-***-**, The 3rd * denote the standard rated output voltage designation, which can be 05 to 54 or 5.0 to 54.0 in 0.1V increments. The 4th * =Blank The 5th * =T2 means desktop class II with C8 AC inlet =T2A means desktop class II with C18 AC inlet =T3 means desktop class I with C AC inlet =T3A means desktop class I with C6 AC inlet =T2L means desktop class II with C8 AC inlet and housing with a DC jack =T2AL means desktop class II with C18 AC inlet and housing with a DC jack =T3L means desktop class I with C AC inlet and housing with a DC jack =T3AL means desktop class I with C6 AC inlet and housing with a DC jack =R2 means hybrid desktop housing class II with C8 AC inlet =R3A means hybrid desktop housing class I with C6 AC inlet =F means Open Frame class I =FW means Open Frame class II =P2 means Encapsulated class II =P3 means Encapsulated class I The last * denote any six character = 0-9 or A-Z or ()[] or or blank for marketing purposes.

4 For details please refer to model list table. Page 4 of 16 Report No SHA-001 Alternate Rating: For models GTM R2 / GTM R3A: output 5VDC, 4.0A at Tma=70 Deg.C; For models GTM R2 / GTM R3A: output 12VDC, 2.0A at Tma=70 Deg.C; For models GTM R2 / GTM R3A: output 36VDC, 0.66A at Tma=70 Deg.C; For models GTM R2 / GTM R3A: output 48VDC, 0.5A at Tma=70 Deg.C; For models GTM R2 / GTM R3A: output 54VDC, 0.44A at Tma=70 Deg.C; Ratings When model is GT*91099-***-**, Input: V~,50-60Hz, 1.5A Output: 5-48Vdc When model is GT*96600-***-**, Input: V~,50-60Hz, 1.5A Output: 5-54Vdc Object/part No. PCB WALEX ELECTRONIC (WUXI) CO SHANGHAI H- FAST ELECTRONIC CO DONGGUAN HE TONG ELECTRONICS CO CHEERFUL ELECTRONIC (HK) DONGGUAN DAYSUN ELECTRONIC CO SHANGHAI AREX PRECISION ELECTRONIC CO BRITE PLUS ELECTRONICS (SUZHOU) CO KUOTIANG ENT SHENZHEN TONGCHUANGXI N ELECTRONICS CO T2 T2A T2B T CEM1 2V0 FR A DS2 02V0 04V0 DKV0-3A DGV0-3A C-2 C-2A TCX IEC UL E UL E UL E UL E UL E UL E UL E UL E UL E250336

5 Fuse (FS1,FS2 or F1, F2) (FS2 or F2 is optional) (FS1, FS2 for GT*91099 series, F1, F2 for GT*96600 series) PACIFIC WIN INDUSTRIAL YUANMAN PRINTED CIRCUIT CO SUZHOU XINKE ELECTRONICS CO KUNSHAN CITY HUA SHENG CIRCUIT BOARD CO HUIZHOU SHUNJIA ELECTRONICS CO NANTONG HAIZHOU ELECTRONICAL TECHNOLOGY CO Conquer Ever Island Electric Co., And Walter Electric Page 5 of 16 Report No SHA-001 PW-02 PW-03 1V0 XK-2 XK-3 HS-S SJ-B HZ-S HZ-D MST series T3.15A, 250V IEC UL , ICP T3.15A, 250V IEC UL 248- Bel Fuse RST-Serie(s) T3.15A, 250V IEC Cooper Bussmann LLC UL 248- SS-5 T3.15A, 250V IEC UL 248- UL E UL E74757 UL E UL E UL E UL E VDE UL E82636 VDE UL E VDE UL E20624 VDE UL E19180

6 Y capacitor (CY1, CY2) (Optional) Shenzhen Lanson Electronics Co. Das & Sons International Dongguan Better Electronics Technology Co., Hollyland Company Limited Sunny East Enterprise Co. Conquer Zhongshan Lanbao Electrical Appliances Co., TDK-EPC, Capacitors Group Circuit Devices Business Group Success Success Page 6 of 16 Report No SHA-001 SMT T3.15A, 250V IEC UL T series T3.15A, 250V IEC UL T3.15A, 250V IEC UL 248-5ET T3.15A, 250V IEC UL 248- CFD-Serie(s) T3.15A, 250V IEC UL 248- MET series T3.15A, 250V IEC RTI-10 Serie(s) CD SE SB UL 248- T3.15A, 250V IEC Y1, AC250V, max 25/085/21/B Y1, AC250V, or AC500V, max 40/125/56/C Y1, AC250V, max 40/125/56/C UL 248- UL UL UL UL UL UL VDE UL E2265 VDE UL E VDE UL E VDE UL E VDE UL E VDE UL E82636 VDE UL E VDE UL E37861 VDE VDE UL E1280 VDE VDE UL E1280

7 Murata Mfg. Co., Walsin Technology Corp. KX AH Page 7 of 16 Report No SHA-001 Y1, AC250V, max 25/125/21/B Y1, AC250V, max 25/125/21/C JYA-NAY Co., JN Y1, AC250V, max 25/125/21/C X capacitor (CX1) (Optional) Haohua Electronic Co. Jyh Chung Electronic Co., Jerro Electronics Corp. WELSON INDUSTRIAL CO LT D Cheng Tung Industrial Co., Tenta Electric Industrial Co. Joey Electronics (Dong Guan) Co., CT 7 JD JX-series WD CTX MEX MPX Y1, AC250V, max 30/125/56/C Y1, AC250V, max 40/085/21/C Y1, AC250V, max 40/125/21/C Y1, AC250V, max 55/125/21/C Min. 300VAC, 110 o C, X1 or X2 40/100/21/B, X1 or X2 40/105/21/B, X1 or X2 UL UL UL UL UL UL UL UL UL UL UL UL UL UL UL UL UL UL VDE UL E37921 VDE UL E6544 VDE UL E VDE UL E VDE UL E VDE UL E VDE UL E VDE UL E VDE UL E216807

8 Ultra Tech Xiphi Enterprise Co. Yuon Yu Electronics Co. Sinhua Electronics (Huzhou) Co., Jiangsu Xinghua Huayu Electronics Co., Dain Electronics Co., Shenzhen Jinghao Capacitor Co., Foshan Shunde Chuang Ge Electronic Industrial Co., Okaya Electric Industries Co. VISHAY Capacitors Belgium NV Winday Electronic Industrial Co., Page 8 of 16 Report No SHA-001 HQX MPX MPX MPX - Series MEX, MPX, NPX CBB62B MKP-X2 RE-Series F 1772 MPX series 40/100/21/C, X1 or X2 40/100/21/C, X1 or X2 40/100/21/C, X1 or X2 40/100/21/C, X1 or X2 40/100/21/C, X1 or X2 40/110/56/B, X1 or X2 40/105/21/B, X2 55/100/56/C, X2 40/100/56/C, X2 40/100/21/C, X2 UL UL UL UL UL UL UL UL UL UL UL UL VDE UL E VDE UL E VDE UL E VDE UL E VDE UL E7776 VDE UL E VDE VDE VDE VDE

9 Photo coupler (U1 or U4) (U1 for GT*91099 series, U4 for GT*96600 series) Varistor MOV1 or MOV(Optional) Everlight COSMO Electronics Lite-On Technology Fairchild Semiconductor Pte Sharp Electronic Components and Devices Group Bright Led Electronics Corp. Toshiba Semiconductor & Storage Products Company Thinking Electronic Industrial Co., Page 9 of 16 Report No SHA-001 EL817 Dti=0.5mm Int., K1010 / KP1010 dcr=6.0mm EXT.dcr=7.7mm, thermal cycling test,110 o C Dti=0.6mm Int., dcr=4.0mm EXT.dcr=5.0mm, thermal cycling test,115 o C LTV-817 Dti=0.8mm Int., H11A817B / FOD817B PC817 BPC-817 A/B/C/D/L BPC-817 M BPC-817 S TLP817F TVR10471K, TVR471K EXT.dcr=7.8mm, thermal cycling test,100 o C Insulation voltage: 850V; Transient overvoltage: 6000V; CTI175; Int. Cr/ Ext. Cr: 7,0/ 7,0 mm; 30/110/21 Insulation voltage: 890V; Transient overvoltage: 9000V Int. Cr/ Ext. Cr: 7.62/ 7.62 mm; 30/100/21 Dti=0.4mm EXT.dcr=7.0mm, thermal cycling test,100 o C Dti > 0.4mm, Ext cr > 8.0mm, Isolation 3000Vac min., 110 C min., Thermal cycling test Max. Continuous voltage: min 300Vac(rms), 85 C, The coating is V-0 IEC/EN IEC/EN IEC/EN IEC/EN IEC/EN IEC/EN IEC/EN IEC IEC IEC VDE VDE VDE VDE VDE VDE VDE VDE

10 Centra Science Corp. Success Walsin Technology Co., Lien Shun Ceramate Techn. Co., Brightking (Shenzhen) Co., Page 10 of 16 Report No SHA D471K, D471K SVR10D471K SVRD471K D471K D471K GNR10D471K GNRD471K D471K 10D471K Joyin Co., JVR10N471K JVRN471K Appliance inlet CN1 Class I units(c6 type) Zhejiang LECI Max. Continuous voltage: min 300Vac(rms), 85 C, The coating is V-0 Max. Continuous voltage: min 300Vac(rms), 85 C, The coating is V-0 Max. Continuous voltage: min 300Vac(rms), 85 C, The coating is V-0 Max. Continuous voltage: min 300Vac(rms), 85 C, The coating is V-0 Max. Continuous voltage: min 300Vac(rms), 85 C, The coating is V-0 Max. Continuous voltage: min 300Vac(rms), 85 C, The coating is V-0 Max. Continuous voltage: min 300Vac(rms), 85 C, The coating is V-0 IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC IEC VDE VDE VDE VDE VDE VDE VDE DB-6 2.5A, 250Vac IEC/EN VDE Rich Bay Co., R A, 250Vac IEC/EN VDE Sun Fair Electric Wire & Cable (HK) Co. TECX-UNIONS Technology Rong Feng Industrial Co., Inalways S A, 250Vac IEC/EN VDE TU A, 250Vac IEC/EN ENEC RF A, 250Vac IEC/EN VDE A, 250Vac IEC/EN ENEC

11 Page 11 of 16 Report No SHA-001 Zhe Jiang Bei Er jia ST-A A, 250Vac IEC/EN VDE Appliance inlet CN1 Class I units (C type) Shenzhen Delikang Electronics Technology Co. Zhejiang LECI CDJ-2 2.5A, 250Vac IEC/EN VDE DB- 10A, 250Vac IEC/EN VDE Rich Bay Co., R-301SN 10A, 250Vac IEC/EN VDE Sun Fair Electric Wire & Cable (HK)Co. TECX-UNIONS Technology S-03 10A, 250Vac IEC/EN VDE TU-301-S, TU-301-SP 10A, 250Vac IEC/EN ENEC Rong Feng SS A, 250Vac IEC/EN VDE Industrial Co., Inalways A, 250Vac IEC/EN ENEC Zhe Jiang Bei Er jia ST-A01-003J 10A, 250Vac IEC/EN VDE Appliance inlet CN1 Class II units (C8 type) Zhejiang LECI DB-8 2.5A, 250Vac IEC/EN VDE Rich Bay Co., R-201SN90 2.5A, 250Vac IEC/EN VDE Sun Fair Electric S A, 250Vac IEC/EN VDE Wire & Cable (HK)Co. TECX-UNIONS SO A, 250Vac IEC/EN VDE Technology Rong Feng RF A, 250Vac IEC/EN VDE Industrial Co., Inalways A, 250Vac IEC/EN ENEC Zhe Jiang Bei Er jia ST-A A, 250Vac IEC/EN VDE Input connector CN1 (For open frame) Shenzhen Delikang Electronics Technology Co. NELTRON INDUSTRIAL CO JOINT TECH ELECTRONIC INDUSTRIAL CO CDJ-8 2.5A, 250Vac IEC/EN VDE S A7920 series A3960 series Min 240V; Min 1.5A; Flame class min. V-2; Min 250V; Min 7A; Flame class min. V-2; IEC/EN UL E4392 IEC/EN UL E179987

12 Earthing wire for Class I model Connection wiring for encapsulated models ZHEJIANG HONGXING ELECTRICAL CO KUNSHAN NEW ZHICHENG ELECTRONICS TECHNOLOGIES CO ZHUANG SHAN CHUAN ELECTRICAL PRODUCTS (KUNSHAN) CO DONGGUAN CHUANTAI WIRE PRODUCTS CO YONG HAO ELECTRICAL INDUSTRY CO DONGGUAN GUNEETAL WIRE & CABLE CO SHENG YU ENTERPRISE CO KUNSHAN XINGHONGMENG ELECTRONIC CO SUZHOU YEMAO ELECTRONIC CO KUNSHAN NEW ZHICHENG ELECTRONICS TECHNOLOGIES CO Page 12 of 16 Report No SHA-001 HX396XX- YYY series 1015, 1007, 1015, 1007, 1015, 1007, 1015, 1007, 1015, 1007, 1015, 1007, 1015, 1007, 1015, 1007, 1015, 1007, 2468, 2464, Min 250V; Min 5A; Flame class min. V-2; IEC/EN UL E IEC/EN UL E IEC/EN UL E IEC/EN UL E IEC/EN UL E IEC/EN UL E IEC/EN UL E IEC/EN UL E IEC/EN UL E IEC/EN UL E Interchangeable 1015, 1007, 2468, 2464,, SPT-1, SPT-2 Min. 20AWG, min. 300Vac, min. IEC/EN UL 758 UL approved

13 Page 13 of 16 Output cord Interchangeable Interchangeabl e Heatshrinkable tubing (Optional) Transformer (T1) SHENZHEN WOER HEAT- SHRINKABLE MATERIAL CO QIFURUI ELECTRONICS CO DONGGUAN SALIPT CO GUANGZHOU KAIHENG ENTERPRISE GROUP CHANGYUAN ELECTRONICS (SHENZHEN) CO GlobTek / BOAM / HAOPUWEI - Magnet wire PACIFIC ELECTRIC WIRE & CABLE (SHENZHEN) CO PACIFIC ELECTRIC WIRE & CABLE (SHENZHEN) CO JUNG SHING WIRE CO JUNG SHING WIRE CO JIANGSU HONGLIU MAGNET WIRE TECHNOLOGY CO CHANGZHOU DAYANG WIRE & CABLE CO RSFR, RSFR- H, RSFR-HPF Min. 24AWG, min. 300Vac, min. Report No SHA-001 IEC/EN UL 758 UL approved 600V, 125 o C IEC/EN QFR-h 600V, 125 C IEC/EN UL 224 SALIPT S SALIPT S K-2 (+) K-2 (CB) Min. 300V, 125 C IEC/EN UL 224 Min. 300V, 125 C IEC/EN UL 224 CB-HFT Min. 300V, 125 C IEC/EN UL 224 See attachment for details UEWN/U (UL E201757) UEWS/U (UL E201757) UEW-4 (UL E174837) UEY-2 (UL E174837) 2UEW/130 (UL E335065) 2UEW/130 (UL E158909) Class B, with critical component listed below UL E in UL E in UL E in UL E2175 in UL E MW28-C, 130 o C MW75-C, 130 o C MW75C, 130 o C MW28-C, 130 o C MW75-C, 130 o C MW75-C, 130 o C

14 -Tripleinsulated wire (Secondary) WUXI JUFENG COMPOUND LINE CO JIANGSU DARTONG M & E CO SHANDONG SAINT ELECTRIC CO ZHEJIANG LANGLI ELECTRIC EQUIPMENTS CO Great Leoflon Industrial Co., - COSMOLINK CO. - Furukawa Electric Co., Electronics & Automotive Systems Company Global Business Development Division - TOTOKU ELECTRIC CO - E&B TECHNOLOGY CO - CHANGYUAN ELECTRONICS (SHENZHEN) CO - SHENZHEN JIUDING NEW MATERIAL CO -Bobbin CHANG CHUN PLASTICS CO Page of 16 Report No SHA-001 2UEWB (UL E206882) UEW (UL E237377) UEW/130 (UL E194410) UEW (UL E2222) TRW (B) Serie(s) TIW-M Serie(s) MW75#, 130 o C MW 75-C, 130 o C MW75#, 130 o C MW 79#, 130 o C Class B, reinforced insulation Class B, reinforced insulation TEX-E Class B, reinforced insulation TIW-2 E&B-XXXB E&B-XXXB-1 CB-TIW DTIW-B T375J T375HF Reinforced insulation, rated 130 C (Class B) Reinforced insulation, Class B Reinforced insulation, Class B Reinforced insulation, Class B V-0, 150 C, thickness 0,45 mm min. UL 2353 UL UL 2353 UL UL 2353 UL UL 2353 UL UL UL 2353 UL UL 2353 UL UL 2353 UL VDE UL E VDE UL E VDE UL E VDE UL E VDE UL E UL E VDE UL E UL E59481

15 - CHANG CHUN PLASTICS CO - SUMITOMO BAKELITE CO - HITACHI CHEMICAL CO -Insulating tape 3M COMPANY ELECTRICAL MARKETS DIV (EMD) - BONDTEC PACIFIC CO - JINGJIANG YAHUA PRESSURE SENSITIVE GLUE CO - JINGJIANG JINGYI ADHESIVE PRODUCT CO - CHANG SHU LIANG YI TAPE INDUSTRY CO -PTFE tubing - - Enclosure (all parts) GREAT HOLDING INDUSTRIAL CO SHENZHEN WOER HEAT- SHRINKABLE MATERIAL CO CHANGYUAN ELECTRONICS (SHENZHEN) CO SABIC INNOVATIVE PLASTICS B V Page 15 of 16 Report No SHA V-0, 0 C, thickness 0,74 mm min. PM-9820 CP-J F T-1 44 V-0, 150 C, thickness 0,45 mm min. V-0, 150 C, thickness 0,45 mm min. Min.130 C UL S Min.130 C PZ CT WF UL 510 Min.130 C UL 510 JY25-A Min.130 C UL 510 LY-XX Min.130 C UL 510 UL E59481 UL E429 UL E42956 UL E17385 UL E UL E UL E UL E TFT / TFS Min. 300V, 200 o C UL E WF 600V, 200 o C CB-TT-T / CB- TT-S Min. 300V, 200 o C SE1X, SE1 PPE+PS, Min. V- 1, Min. thickness: 2.0mm, 105 C UL E UL E UL E45329

16 SABIC INNOVATIVE PLASTICS B V SABIC INNOVATIVE PLASTICS B V SABIC INNOVATIVE PLASTICS B V SABIC INNOVATIVE PLASTICS B V SABIC INNOVATIVE PLASTICS B V TEIJIN CHEMICALS CHI MEI CORPORATION CHI MEI CORPORATION Supplementary information: Page 16 of 16 Report No SHA-001 SE100 PPE+PS, Min. V- 1, Min. thickness: 2.0mm, 95 C C2950 PC/ABS, Min. V- 0, Min. thickness: 2.0mm, 85 C CX7211 EXCY0098 PC/ABS, Min. V- 1, Min. thickness: 2.0mm, 90 C 945 PC, Min. V-1, Min. thickness: 2.0mm, 120 C HF500R LN-1250P LN-1250G PA-765A PC, V-0, Min. thickness: 2.0mm, 125 C PC, Min. V-0, Min. thickness: 2.0mm, 115 C ABS, Min. V-0, Min. thickness: 2.0mm, 85 C PC-540 PC/ABS, Min. V- 0, Min. thickness: 2.0mm, 70 C 1) Provided evidence ensures the agreed level of compliance. See OD-CB2039. For all transformers under all manufacturers. UL E45329 UL E45329 UL E45329 UL E45329 UL E45329 UL E50075 UL E56070 UL E56070

Listing Constructional Data Report (CDR)

Listing Constructional Data Report (CDR) 1.0 Reference and Address Report Number 160800341SHA-002 Original Information Technology Equipment Safety Part 1: General Requirements (UL 60950-1 Issued: 2007/03/27