Appendix I Specifications; A1.1 Classification; A1.2 Specifications; A1.2.1 Size And Weight - EDAN iM8 Series User Manual

Patient Monitor User Manual

Appendix I Specifications

A1.1 Classification

Anti-electroshock Type
Anti-electroshock Degree
Ingress Protection
Disinfection/Sterilizing method
Working System
Compliant with Standards

A1.2 Specifications

A1.2.1 Size and Weight

Weight

A1.2.2 Environment

The monitor may not meet the performance specifications given here if stored or used outside the
specified temperature and humidity ranges.
When the monitor and related products have differing environmental specifications, the effective
range for the combined products is that range which is common to the specifications for all
products.
Temperature
Working
Transport and Storage
Humidity
Class I equipment and internal powered equipment
ECG (RESP), TEMP, IBP CF
SpO , NIBP, CO
2 2
IPX1
Refer to Chapter 12 ~ Chapter 17 for details.
Continuous operation equipment
IEC 60601-1: 1988+A1: 1991+A2: 1995; EN 60601-1:
1990+A1: 1993+A2: 1995; IEC 60601-1-2: 2001+A1:
2004; EN 60601-1-2: 2001+A1: 2006; IEC/EN
60601-2-27; IEC/EN 60601-2-30; IEC/EN 60601-2-34;
IEC/EN 60601-2-49; ISO 9919; ISO 21647; EN
12470-4; EN 1060-1; EN 1060-3; EN 1060-4;
ANSI/AAMI EC13; ANSI/AAMI SP10
< 5 kg (not including the battery and record)
+5°C to +40°C
-20°C to +55°C
- 150 -
Specifications
BF