Standards Compliance And Iec Classification; Table A-24. Compliant Cables And Accessories - Covidien Puritan Bennett 560 User Manual

Table A-24. Compliant Cables and Accessories

Cable or Accessory
UK AC power cable assembly
Japan AC power cable assembly
China AC power cable assembly
South Africa AC power cable assembly
India AC power cable assembly
Australia AC power cable assembly
Europe AC power cable assembly
Canada AC power cable assembly
Nurse call cable
12V DC car adapter cable
Oxygen inlet connector
A.11 Standards Compliance and IEC Classification
General Standards
Medical Electrical Equipment: General Requirements for Safety IEC 60601-1:1990 and
•
EN 60601-1:1990 and all its amendments up to 1995.
The ventilator will be constructed to comply with the following product Classifications as
•
detailed in Clause 5 of 60601-1:
Class II Equipment
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Internally Powered Equipment
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Type BF Applied Parts
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IP31 with respect to access to hazardous parts and ingress of moisture
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Not suitable for use in the presence of flammable anesthetic mixtures
•
Not suitable for sterilisation
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Suitable for continuous operation
•
Detachable power supply cable
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Supplement No. 1-94 to CAN/CSA-C22.2 No. 601.1-M90 - Medical Electrical Equipment -
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Part 1: General Requirements for Safety.
UL 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety: 2003.
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Collateral Standards
Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral
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standard Electro-Magnetic Compatibility requirements and tests IEC 60601-1-2:2007 and
EN 60601-1-2: 2007.
Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral
•
standard: Programmable Electrical Medical Systems IEC 60601-1-4:2000 and
EN 60601-1-4:2004.
Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral
•
standard: Usability IEC 60601-1-6:2006 and EN 60601-1-6:2007.
General Requirements, tests and guidance for alarm systems in medical electrical equipment
•
and medical electrical systems IEC 60601-1-8:2003 and EN 60601-1-8:2007.
User's Manual
Maximum length
1.8 m (5.9 ft)
1.8 m (5.9 ft)
1.8 m (5.9 ft)
1.8 m (5.9 ft)
1.8 m (5.9 ft)
1.8 m (5.9 ft)
1.8 m (5.9 ft)
1.8 m (5.9 ft)
5 m (16.4 ft)
5 m (16.4 ft)
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Specifications
A-13