Passport V Operating Instructions 0070- 0-0704-02 19 - 31
Appendix Safety Designations
19.14 Safety Designations
19.14.1 Safety Classification
Transportable equipment intended for mobility
Type of Protection Against Electric Shock
Class I equipment
Where the integrity of the external protective earth conductor arrangement is in doubt,
equipment shall be operated from its internal electrical electric power source (battery).
Degree of Protection Against Electric Shock
• ECG/RESP/IBP/TEMP: CF, defibrillation-proof
•SpO
2
/NIBP/CO
2
: BF, defibrillation-proof
Mode of Operation
Continuous
Protection Against Hazards of Explosion
• Not protected (ordinary equipment)
• Not for use in the presence of flammable anesthetic mixture, O
2
or N
2
O.
Protection Against Ingress of Liquids
• Complies with the requirements of IEC60529: 2001, IPX1.
• Complies with the requirements of IEC60601-1:1988+A1:1991+A2:1995.
Electrical Connection Between Equipment and Patient
Direct electrical or non-electrical connection with the patient
19.14.2 Safety Performance Index
Shock
Complies with the requirements specified in ISO 9919: 2005, clause 21.101.
Vibration
• Complies with the requirements of ISO9919: 2005, clause 21.101 b).
• Complies with the requirements of IEC60068-2-6:1995, sinusoidal vibration.
Drop
• Main Unit Drop
• Complies with the requirements of ECRI PB-296 892:1979, section AIII 3.3.
• Packaging Drop
• Complies with the requirements specified in ISTA 2A:2006.
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