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Mindray Passport V - Page 267

Mindray Passport V
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Safety Designations Appendix
19 - 32 0070- 0-0704-02 Passport V Operating Instructions
Impact
Complies with the requirements of ECRI PB-296 892, AIII 3.2.3 for Class 3 equipment.
Static Compression
Complies with the requirements specified in ISTA 2A.
Surface Temperature
Complies with the requirements CSA C22.2 No.601.1 M90:2003
Mechanical Stability
Complies with the requirements of IEC 60601-1: 1997, clause 24.1.
Surface, Corner, Edge
Complies with the requirements of IEC60601-1: 1997
Grip Strength
Complies with the requirements of IEC 60601-1: 1997, clause 21.c.
Incompatibility with External Connectors
Complies with the requirements of IEC 60601-1: 1997, clauses 56.3
Complies with the requirements of FDA Reviewer Guidance for Premarket Notification
Submission November1993, N2
Rigidity and Strength of Enclosure
Complies with the requirements of IEC 60601-1: 1997, clauses 21a, 16a and 21b.
Complies with the requirements of UL 60601-1:2003.
Ball Pressure Test
Complies with the requirements of IEC60601-1: 1997, clause 59.2b.
Impairment of Cooling
Complies with the requirements of IEC 60601-1: 1997, clause 52.5.5
Durability of Markings
Complies with the requirements of IEC60601-1: 1997, clause 6.1.
Leakage Current
Complies with the requirements of CSA C22.2 No.601.1 M90:2003
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