Mindray A5 Operating Instructions

Standards Compliance Product Specifications
9 - 2 046-003777-00 A5/A3™ Operating Instructions
9.1 Standards Compliance
The A5/A3 Anesthesia System is in compliance with the following industry standards.
The anesthesia workstation shall be used together with the monitoring devices, alarm system and
protective devices below:
ISO 10993-1: 2009 Biological Evaluation of Medical Devices - Part 1:
Evaluation and Testing
ISO 15223-1: 2012 Medical Devices - Symbols to be used with Medical
Device labels, labelling and information to be
supplied
ASTM F1101-90 (2003) Standard Specification for Ventilators Intended for
Use During Anesthesia
CGA V-1: 2005 Standard for Compressed Gas Cylinder Valves Outlet
and Inlet Connections
CGA V-5: 2008 Diameter-Index Safety System (Non-
interchangeable Low Pressure Connections for
Medical Gas Applications
IEC 60068-2-27: 2008/EN 60068-2-27: 2009 Basic Environmental Testing Procedures. Part 2 Tests
- Tes Ea and Guidance: Shock
IEC 60068-2-64: 2008/EN 60068-2-64: 2008 Environmental Testing: Part 2: Test Methods, Test Fh:
Vibration, Broad-band Random (Digital Control) and
Guidance
ANSI / AAMI ES60601-1:2005/(R)2012 and
C1:2009/(R)2012 and, A2:2010/(R)2012
(consolidated text)
Medical electrical equipment - Part 1: General
requirements for basic safety and essential
performance
IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General
Requirements for Basic Safety and Essential
Performance - Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests
IEC 60601-1-8: 2006 Collateral Standard: General Requirements, Tests
and Guidance for Alarm Systems in Medical
Electrical Equipment and Medical Electrical Systems
ISO 80601-2-13:2011 Medical electrical equipment —Part 2-13: Particular
requirements for basic safety and essential
performance of an anaesthetic workstation
IEC 62304: 2006 Medical Device Software - Software Life Cycle
Processes
IEC 62366: 2007 Medical Devices - Application of Usability
Engineering to Medical Devices
ISO 14971: 2007 Medical Devices - Application of Risk Management
to Medical Devices
ISO 80601-2-55:2011 Medical electrical equipment - Part 2-55: Particular
requirements for the basic safety and essential
performance of respiratory gas monitors
ISO 5356-1: 2004 Anaesthetic and Respiratory Equipment - Conical
Connectors - Part 1: Cones and Sockets
TABLE 9-1 Standards Compliance

Mindray A5 Specifications

General

Type	Anesthesia Machine
Brand	Mindray
Model	A5
Power Supply	100-240 V AC, 50/60 Hz
Ventilation Modes	SIMV, PSV
Flowmeters	O2, N2O, Air
Vaporizer Capacity	Up to 3 vaporizers
Safety Features	O2 failure protection, low pressure alarm
Gas Module	Optional integrated gas module
Integrated Air Compressor	Optional
Patient Monitoring	Integrated monitoring with optional modules