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Specifications
User’s Manual
A-13
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
•
Internally Powered Equipment
•
Type BF Applied Parts
•
IP31 with respect to access to hazardous parts and ingress of moisture
•
Not suitable for use in the presence of flammable anesthetic mixtures
•
Not suitable for sterilisation
•
Suitable for continuous operation
•
Detachable power supply cable
•
Supplement No. 1-94 to CAN/CSA-C22.2 No. 601.1-M90 - Medical Electrical Equipment -
Part 1: General Requirements for Safety.
•
UL 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety: 2003.
Collateral Standards
•
Medical Electrical Equipment - Part 1: General Requirements for Safety -2- Collateral
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.
Table A-24.
Compliant Cables and Accessories
Cable or Accessory
Maximum length
UK AC power cable assembly
1.8 m (5.9 ft)
Japan AC power cable assembly
1.8 m (5.9 ft)
China AC power cable assembly
1.8 m (5.9 ft)
South Africa AC power cable assembly
1.8 m (5.9 ft)
India AC power cable assembly
1.8 m (5.9 ft)
Australia AC power cable assembly
1.8 m (5.9 ft)
Europe AC power cable assembly
1.8 m (5.9 ft)
Canada AC power cable assembly
1.8 m (5.9 ft)
Nurse call cable
5 m (16.4 ft)
12V DC car adapter cable
5 m (16.4 ft)
Oxygen inlet connector
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Summary of Contents for Puritan Bennett 560
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Page 32: ...Safety Information 1 18 User s Manual Figure 1 4 Location of Labels Bottom View 7 13 1 4 3...
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