Spirolab
Rev.1.8
Page 23 of 60
Transport conditions
Temperature: MIN -40 °C, MAX + 70 °C
Humidity: MIN 10% RH; MAX 95%RH
Athmospheric pressure: 50kPa, 106 kPa
Operating conditions
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH
Athmospheric pressure: 70kPa, 106 kPa
Applicable standards
IEC 60601-1
:
2005 + A1: 2012 (Electrical Safety)
IEC 60601-1-2:2015 (EMC)
ATS/ERS Guidelines: 2005
ISO 26782: 2009
ISO 23747: 2015
EN ISO 14971: 2012
ISO 10993-1: 2018
2011/65/UE Directive
EN ISO 15223:2016
EN IEC 60601-1-6: 2010+Amd2013
ISO 80601-2-61: 2017
IEC 60601-1-8: 2006
Key performance (in
accordance with IEC 60601-1:
2005 + A1: 2012)
Error of displayed numeric value: Flow
measurement percentage error < ± 5%
Measurement of oximetry parameters with
accuracy as defined in the table on § 1.5.2
Emission limits
CISPR 11 Group 1 Class B
Electrostatic discharge
protection
8kV contact, 15kV air
Magnetic field immunity
30 A/m
Radio Frequency Immunity
3V/m @ 80-2700 MHz
MIR will make available on request circuit diagrams, component part lists, descriptions,
calibration instructions, or other information that will assist service personnel to repair
those part of the device that are designated by MIR as repairable by service personnel.
