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50259145 001 168117080
Test Report No.: Order No.: Page 1 of 130
Kunden-Referenz-Nr.: Auftragsdatum:
N/A May. 27, 2019
Client Reference No.: Order date:

Auftraggeber: Guilin Woodpecker Medical Instrument Co., Ltd.

Client: Information Industrial Park, Guilin National High-Tech Zone, Guilin, Guangxi, 541004,
China
Prüfgegenstand:
Test item: Endo Motor

Bezeichnung / Typ-Nr.:
Ai-Motor, MotoPex
Identification / Type No.:

Auftrags-Inhalt: Type test

Order content:

Prüfgrundlage: IEC 60601-1: 2005 + AM1 (2012); EN 60601-1:2006+A11:2011+A1:2013+ A12:2014;

Test specification: IEC 80601-2-60:2012; EN 80601-2-60:2015

Wareneingangsdatum:
Jun. 03, 2019
Date of receipt:
Prüfmuster-Nr.:
A000925350
Test sample No.:
Prüfzeitraum:
Jun. 06, 2019 to Jun. 17, 2019
Testing period:
See photo documentation
Ort der Prüfung: TÜV Rheinland (Shenzhen)
Place of testing: Co., Ltd.
Prüflaboratorium: TÜV Rheinland (Shenzhen)
Testing laboratory: Co., Ltd.
Prüfergebnis*:
Pass
Test result*:
geprüft von / tested by: kontrolliert von
on / re
reviewed by:

Jun. 26, 2019 Javen Ke / Assistant Project Engineer Jun. 26, 2019 Angela Chen/ Department Manager
Datum Name / Stellung Unterschrift Datum Name / Stellung Unterschrift
Date Name / Position Signature Date Name / Position Signature
Sonstiges / Other:
This completed test report consists of IEC 60601-1 test report (including this cover page) and following
attachments: - Attachment 1: IEC 80601-2-60:2012 report (16 pages); - Attachment 2: Photo documentation (24
pages).

Zustand des Prüfgegenstandes bei Anlieferung: Prüfmuster vollständig und unbeschädigt

Condition of the test item at delivery: Test item complete and undamaged
* Legende: 1 = sehr gut 2 = gut 3 = bef riedigend 4 = ausreichend 5 = mangelhaf t
P(ass) = entspricht o.g. Prüfgrundlage(n) F(ail) = entspricht nicht o.g. Prüfgrundlage(n) N/A = nicht anwendbar N/T = nicht getestet
Legend: 1 = very good 2 = good 3 = satisfactory 4 = sufficient 5 = poor
P(ass) = passed a.m. test specification(s) F(ail) = failed a.m. test specification(s) N/A = not applicable N/T = not tested

Dieser Prüfbericht bezieht sich nur auf das o.g. Prüfm uster und darf ohne Genehm igung der Prüfstelle nicht
auszugsw eise vervielfältigt w erden. Dieser Bericht berechtigt nicht zur Verwendung eines Prüfzeichens.
This test report only relates to the a. m. test sample. Without permission of the test center this test report is not permitt ed to be
duplicated in extracts. This test report does not entitle to carry any test mark.

TÜV Rheinland (Shenzhen) Co., Ltd., East of F/1, F/2 - F/4, Building 1, Cybio Technology Building, No. 6 Langshan No. 2 Road,
North Hi-tech Industry Park, Nanshan District, Shenzhen, P.R. China
http://www.tuv.com
 Page 2 of 130 Report No. 50259145 001

IEC 60601-1
Medical electrical equipment
Part 1: General requirements for basic safety and essential performance
Report Reference No. ................. : 50259145 001
Date of issue .............................. : See cover page
Total number of pages................ : See cover page

CB Testing Laboratory................ : TÜV Rheinland (Shenzhen) Co., Ltd.

Address ..................................... : East of F/1, F/2 - F/4, Building 1, Cybio Technology Building, No. 6
Langshan No. 2 Road, North Hi-tech Industry Park, Nanshan
District, Shenzhen, P.R. China

Applicant’s name........................ : Guilin Woodpecker Medical Instrument Co., Ltd.

Address ..................................... :
Test specification:
Standard.................................... :
Test procedure ........................... :
Non-standard test method………..:
Information Industrial Park, Guilin National High-Tech Zone, Guilin,
Guangxi, 541004, China
IEC 60601-1:2005 (Third Edition) + A1:2012
(or IEC 60601-1: 2012 reprint)
Type Test
N/A

Test Report Form No. ................. : IEC60601_1K

Test Report Form Originator ....... : UL(US)
Master TRF ................................ : 2015-11

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 part for non -commercial purposes as long as the IECEE is acknowledged as
copyright owner and source of the material. IECEE takes no responsibility for and will not assume liability for damages resul ting from the
reader's interpretation of the reproduced material due to its placement and context .

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.

TRF No. IEC60601_1K

 Page 3 of 130 Report No. 50259145 001

Test item description.................... : Endo Motor

Trade Mark................................... :
, , or
Manufacturer................................ : Same as the applicant
Model/Type reference ................... : Ai-Motor, MotoPex
Ratings........................................ : Hand piece: rechargeable Li-ion battery, DC 3.7V, 2000mAh
Charging base: DC 5V,1.0A
Adaptor (model: DJ-0500100-A5, refer to table 8.10 for details)

Testing procedure and testing location:

CB Testing Laboratory:
Testing location/ address ........................ :
Associated CB Testing Laboratory:
Testing location/ address ........................ :
Tested by (name, function, signature) ...... :
Approved by (name, function, signature).. :
TÜV Rheinland (Shenzhen) Co., Ltd.
East of F/1, F/2 - F/4, Building 1, Cybio Technology
Building, No. 6 Langshan No. 2 Road, North Hi-tech
Industry Park, Nanshan District, Shenzhen, P.R. China
N/A
See cover page
See cover page

Testing procedure: CTF Stage 1: N/A

Testing location/ address ........................ :
Tested by (name, function, signature) ...... :
Approved by (name, function, signature).. :

Testing procedure: CTF Stage 2: N/A

Testing location/ address ........................ :
Tested by (name, function, signature) ...... :
Witnessed by (name, function, signature). :
Approved by (name, function, signature).. :

Testing procedure: CTF Stage 3: N/A

Testing procedure: CTF Stage 4: N/A
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. IEC60601_1K