Mindray A7 Operating Instructions

A7™ Operating Instructions 046-004667-00 9 - 23
Product Specifications ASTM F 1208 – 89 (2005) Disclosures
9.16 ASTM F 1208 – 89 (2005) Disclosures
Based on the following disclosures, the A7 complies with ASTM Standard Specification F1208 for
Anesthesia Breathing Systems.
9.16.1 Leakage of Breathing System
Mechanical Stability: Complies with the requirements of clause 9.4 in IEC 60601-1.
Incompatibility with
External Connectors:
Complies with the requirements of clause 15.4 in IEC 60601-1.
Enclosure Rigidity and
Strength:
Complies with the requirements of clauses 15.3.2, 15.3.3, 15.3.6, and 15.3.7 in
IEC 60601-1.
Impairment of
Cooling:
Complies with the requirements of clause 13.2.7 in IEC 60601-1.
Leakage Current: Complies with the requirements of clause 8.7 in IEC 60601-1.
Earth leakage current:
• Normal condition ≤ 500 A
• Single fault condition ≤ 1000 A
Enclosure leakage current:
• Normal condition ≤ 100 A
• Single fault condition ≤ 300 A
Patient leakage current:
• Normal condition ≤ 100 A
• Single fault condition ≤ 500 A
Patient auxiliary current DC:
• Normal condition ≤ 10 A
• Single fault condition ≤ 50 A
Patient auxiliary current AC:
• Normal condition ≤ 100 A
• Single fault condition ≤ 500 A
Patient leakage current (applied part plus mains voltage):
• Single fault condition ≤ 5000 A
Dielectric Strength: Complies with the requirements of clause 8.8.3 in IEC 60601-1.
Mains supply to earth (1MOOP): 1500 VRMS, 1 min
Mains supply to applied part (2MOOP): 4000 VRMS, 1 min
Applied part to earth (1MOOP): 1500 VRMS, 1 min
Isolation at network port: 1500 VRMS, 1 min
Grounding
Impedance:
Complies with the requirements of clause 8.6 in IEC 60601-1.
The impedance between the protective earth terminal and any accessible
metal part (e.g., screw and equipotential stud) that is protectively earthed
does not exceed 0.1 ohm.
Protective Grounding: Complies with the requirements of clause 8.6 in IEC 60601-1.
The protective earth terminal is not used for the mechanical connection
between different parts of the equipment or the fixing of any component not
related to protective earthing or functional earthing.
TABLE 9-35
Safety Specifications
Mode Resistance Pressure
Leakage
(Manual mode, Bypass Off)
20.12 ml/min @ 3 kPa
TABLE 9-36
Leakage of Breathing System

Mindray A7 Specifications

General

Brand	Mindray
Model	A7
Category	Medical Equipment
Language	English