IEC 60601-1 Medical electrical equipment - Invacare

1 Page 1 of 172 IEC 60601 -1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance Report Reference No.. : Date of issue .. : Total number of pages .. : 172 CB Testing Laboratory .. : T V S D Certification and Testing (China) Co., Ltd. Guangzhou Branch Address .. : 5F, Communication Building, 163 Pingyun Rd, Huangpu West Ave. Guangzhou 510656 P. R. China Applicant s name .. : SHL Healthcare Ltd Address .. : Room 810, Argyle centre, 688 Nathan Road, Kowloon, Hongkong Test specification: Standard .. : IEC 60601 -1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) or IEC 60601 -1: 2012 Test : Voluntary test Non-standard test : None Test Report Form No.. : IEC60601_1H Test Report Form Originator .. : UL(US) Master TRF .. : Dated 2012-12 Copyright 2012 IEC System for Conformity Testing and Certification of electrical equipment (IECEE), Geneva, Switzerland.

2 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 resulting from the reader's interpretation of the reproduced material due to its placement and context. If this Test Report Form is used by non-IECEE members, the IECEE/IEC logo 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. Test item description ..: Alternating Control Unit Trade Mark ..: Manufacturer ..: Invacare Operations UK Ltd. Model/Type : SoftAIR Ratings ..: 220-240 VAC, 50/60 Hz, A Page 3 of 172 Report No.: TRF No. IEC60601_1H List of Attachments (including a total number of pages in each attachment): Attachment 1: photo documents with 16 pages.

3 Summary of testing Tests performed (name of test and test clause): Testing location: All applicable tests. Exceptions: The following clauses / collaterals were not part of the manufacturers order and therefore excluded from this testing: Clause protective packaging, referencing ISO780 Clause Biocompatibility, referencing ISO 10993 Clause Usability, referencing IEC 60601 -1-6 Clause 17 EMC, referencing IEC 60601 -1-2 T V S D Certification and Testing (China) Co., Ltd. Guangzhou Branch /5F, Communication Building, 163 Pingyun Rd, Huangpu West Ave. Guangzhou 510656 P. R. China Summary of compliance with National Differences List of countries addressed: The product fulfils the requirements of _____ (insert standard number and edition and delete the text in parenthesis or delete the whole sentence if not applicable) Page 4 of 172 Report No.: TRF No. IEC60601_1H Copy of marking plate The artwork below may be only a draft.

4 The use of certification marks on a product must be authorized by the respective NCBs that own these marks. Label of model SoftAIR: Page 5 of 172 Report No.: TRF No. IEC60601_1H GENERAL INFORMATION Test item particulars (see also Clause 6): Classification of installation and use .. : Stationary Device type (component/sub-assembly/ equipment / system) .. : equipment Intended use (Including type of patient, application location) .. : See general product information Mode of operation .. : Continuous Supply connection .. : Appliance coupler Accessories and detachable parts included .. : N/A Other options include .. : N/A Testing Date of receipt of test item(s) .. : Nov. 19th , 2014 Dates tests performed .. : Nov. 19th , 2014- Nov. 30th , 2014 Possible test case verdicts: - test case does not apply to the test object .. : N/A - test object does meet the requirement.

5 : Pass (P) - test object was not evaluated for the requirement .. : N/E (collateral standards only) - test object does not meet the requirement .. : Fail (F) Abbreviations used in the report: - normal condition .. : - single fault condition .. : - means of Operator protection .. : MOOP - means of Patient protection .. : MOPP General remarks: "(See Attachment #)" refers to additional information appended to the report. "(See appended table)" refers to a table appended to the report. The tests 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 testing laboratory. List of test equipment must be kept on file and available for review. Additional test data and/or information provided in the attachments to this report. Throughout this report a comma / point is used as the decimal separator. Manufacturer s Declaration per sub-clause of IECEE 02: The application for obtaining a CB Test Certificate includes more than one factory location and a declaration from the Manufacturer stating that the sample(s) submitted for evaluation is (are) representative of the products from each factory has been provided.

6 : Yes Not applicable When differences exist; they shall be identified in the General product information section. Page 6 of 172 Report No.: TRF No. IEC60601_1H Name and address of factory (ies) .. : MED & CARE(Shenzhen) Co., Ltd Bld. 8, A-6 Tongfuyu Industrial Park Bu-chong, Shajing Town Baoan District, Shenzhen, PRC General product information: The product, Alternating Control Unit, provides pressure application and release to patients who are vulnerable to, or suffer from, press ulcers. It contains two parts: control unit and mattress. Condition of acceptability: 1. The usage of the equipment shall be carried out according to the user guide; 2. The product is not suitable used in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide; 3. Only RM report with File No. RM-2012001, Version No. C reviewed; Only user manual (Version v16, English) reviewed.

7 Page 7 of 172 Report No.: IEC 60601 -1 Clause Requirement + Test Result - Remark Verdict TRF No. IEC60601_1H INSULATION DIAGRAM Page 8 of 172 Report No.: IEC 60601 -1 Clause Requirement + Test Result - Remark Verdict TRF No. IEC60601_1H TABLE: To insulation diagram Pollution degree .. : 2 Overvoltage category .. : II Altitude .. : <2000m Additional details on parts considered as applied parts .. : None Areas _____ (See Clause for details) Area Number and type of Means of Protection: MOOP, MOPP CTI (IIIb, unless is known) Working voltage Required creepage (mm) Required clearance (mm) Measured creepage (mm) Measured clearance (mm) Remarks Vrms Vpk 1 2 MOOP IIIb 250 -- 5 4 Between primary circuit and secondary circuit on the PCB. 1 2 MOOP IIIb 250 -- 5 4 between primary winding and secondary winding of Transformer T1 2 1 MOOP IIIb 250 -- pri.

8 Winding to core of Transformer T1 3 1 MOOP IIIb 250 -- core to sec. winding of Transformer T1 4 2 MOOP IIIb 250 -- 5 4 Primary circuits to enclosure via gap. 5 1 MOOP IIIb 240 -- 3 - - Between two poles of mains supply before fuse. Approved appliance coupler and power cord used. 6 2 MOPP IIIb 240 -- 8 5 >>8 >>5 Between live part and applied part via the air Page 9 of 172 Report No.: IEC 60601 -1 Clause Requirement + Test Result - Remark Verdict TRF No. IEC60601_1H tube. 7 2 MOPP IIIb 15 -- >>8 >>5 Secondary circuits to applied part via the air tube. 7 1 MOPP IIIb 250 -- 4 >>8 >>5 Secondary circuits to applied part via the air tube. INSULATION DIAGRAM CONVENTIONS and GUIDANCE: A measured 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.

9 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. Page 10 of 172 Report No.: IEC 60601 -1 Clause Requirement + Test Result - Remark Verdict TRF No. IEC60601_1H 4 GENERAL REQUIREMENTS P Requirements of this standard applied in NORMAL USE and reasonably foreseeable misuse P RISK MANAGEMENT PROCESS FOR ME equipment OR ME SYSTEMS P General requirement for RISK MANAGEMENT - PROCESS complies with ISO14971 (2007).

10 : See Appended RM Results Table P Evaluating RISK P a) Compliance with the standard reduces residual risk to an acceptable level P b) Manufacturer has defined risk acceptability criteria in the RISK MANAGEMENT PLAN .. : RISK MANAGEMENT PLAN Document: RM-2012001, Version No. C P c) When no specific technical requirements provided manufacturer has determined HAZARDS or HAZARDOUS SITUATIONS exists. P - HAZARDS or HAZARDOUS SITUATIONS have been evaluated using the RISK MANAGEMENT PROCESS. P MANUFACTURER has addressed HAZARDS or HAZARDOUS SITUATIONS not specifically addressed in the IEC 60601 -1 series. P Performance of clinical functions necessary to achieve iNTENDED USE or that could affect the safety of the ME equipment or ME SYSTEM were identified during RISK ANALYSIS. Not define essential performance N/A - Performance limits were identified in both NORMAL CONDITION and SINGLE FAULT CONDITION.