Hyperbaric Chamber IEC 60601 1 6 Usability Report

IECEE OD-2020-F1:2017 © IEC 2017 TRF Template

Ed.1.0 2017-05-17

Test Report issued under the responsibility of:

TEST REPORT
IEC 60601-1
Medical electrical equipment Part 1-6
General requirements for safety – Collateral Standard: Usability

Report Number. ………………………… :

Date of issue…………………………….. :

Total number of pages ……………….

Name of Testing Laboratory preparing the Report ………………… :

Applicant’s name ……………………… : Address……………………………………. :

Test specification:
Standard ………………………………….. :

Test procedure …………………………. : Non-standard test method ………… : Test Report Form No. ……………….. : Test Report Form(s) Originator …. : Master TRF ………………………………. :

E505182-D1000-1/A0/C0 2019-05-30
15

UL International Demko A/S Borupvang 5A, 2750 Ballerup, Denmark

Tekna Manufacturing Pvt Ltd

C19,Industrial Estate Guindy Chennai, Tamil Nadu, 600032, India

IEC 60601-1-6:2010, AMD1:2013

for use in conjunction with IEC 62366:2007, AMD1:2014 and IEC 60601-1:2005, COR1:2006, COR2:2007, AMD1: 2012 or equivalent consolidated version IEC 60601-1:2012 (Edition 3.1)

CB Scheme
N/A
IEC60601_1_6H
TÜV Rheinland of North America Dated 2017-08

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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.

Disclaimer: This document is controlled and has been released electronically. Only the version on the IECEE Website is the current document version

Page 2 of 15 Report No. E505182-D1000-1/A0/C0

Test item description………………….. : Trade Mark …………………………………. : Manufacturer ……………………………… :

Model/Type reference …………………. :

Multiplace Hyperbaric Oxygen Therapy Chamber Refer Main Report

Tekna Manufacturing Pvt Ltd, C19,Industrial Estate Guindy Chennai, Tamil Nadu, 600032, India

Hybrid 3200/XX Where XX represents the Inner diameter ranging from 32″ – 42″

Model 5000/XX */L – (YY+ZZ) Where XX represents the inner diameter ranging from 60″ – 120″

Where * represents Single (S)/ Double(D)/ Triple Lock

Where YY represents the number of seats in the Main lock and ZZ represents the number seats in the entry lock (ZZ does not apply for single lock chamber)

Modular Rectangular 6000 XYZ + ABC – */L Where the X represents the number of stretcher Y represents the number of Non-reclinable seats and Z represents the Reclinable seats and A represents the number of seats in the entry lock Where ABC does not apply for Single lock chamber

Where * represents Single (S)/ Double(D)/ Triple Lock

Rectangular 7000 XX/YY */L Where XX represents the number of seats in the Main lock and YY represents the number seats in the entry lock (YY does not apply for single lock chamber)

Where * represents Single (S)/ Double(D)/ Triple Lock

110~120 Vac, 20A 220~240 Vac, 10A Frequency: 50/60Hz

applicable), testing procedure and testing location(s):

Ratings ………………………………………. :

Responsible Testing Laboratory (as

CB Testing Laboratory:
Testing location/ address………………………..: Tested by (name, function, signature)……..:

Testing procedure: CTF Stage 1: Testing location/ address………………………..:

Tested by (name, function, signature)……..: Approved by (name, function, signature)…:

Testing procedure: CTF Stage 2:

UL International Demko A/S

Borupvang 5A, 2750 Ballerup, Denmark

Sreejo Gopinath Handler

Approved by (name, function, signature)…:	Gustav Hoppe, (Reviewer)

TRF No. IEC60601_1_6H

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Hyperbaric Chamber IEC 60601_1_6_Usability Report

Hyperbaric Chamber IEC 60601 1 6 Usability Report