MiniSpir
User manual
MINISPIR
User manual
Rev 1.9
page 13 of 18
Weight
65 grams
Storage conditions
Temperature: MIN -40 °C, MAX + 70 °C
Humidity: MIN 10% RH; MAX 95%RH
Shipping conditions
Temperature: MIN -40 °C, MAX + 70 °C
Humidity: MIN 10% RH; MAX 95%RH
Operating conditions
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH
Compliance with standards
Electrical Safety Standard IEC 60601-1
EMC Standard IEC 60601-1-2
Type of electrical protection
Class II
Grade of electrical protection
BF
Grade of protection against water ingress
IPX1
Level of safety in the presence of
inflammable anaesthetic gas, oxygen or
nitrogen
Not suitable
Conditions of use
Device for continuous use
Storage conditions
Temperature: MIN -20 °C, MAX + 60 °C
Humidity :MIN 10% RH; MAX 95%RH
Atmospheric pressure: 50kPa, 106 kPa
Transport condition
Temperature: MIN -20 °C, MAX + 60 °C
Humidity :MIN 10% RH; MAX 95%RH
Atmospheric pressure: 50kPa, 106 kPa
Operating conditions
Temperature: MIN + 10 °C, MAX + 40 °C;
Humidity: MIN 10% RH; MAX 95%RH
Atmospheric pressure: 70kPa, 106 kPa
Applied norms
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
IEC 60601-1-6: 2010+Amd2013
Essential performances (compliant with EN
60601-1:2005 + A1:2012)
Error of displayed numeric value: Flow measurement percentage error
< ± 5%
Oximetry parameters measuring with accuracy defined in table on
§1.6.2
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
2. FUNCTIONING OF THE
MiniSpir
2.1
Connection to PC
WARNING
Before connecting MiniSpir to a PC, the winspiroPro software must be installed on the PC in order to interface it with the
device.
To make the connection, attach the other connector to the USB port of the PC.
When initially making a connection, the PC will, either make an automatic driver installation or request some information. To avoid
errors in this phase please read the winspiroPRO User Manual very carefully.
To control the proper connection between the device and the PC use the communication check available on winspiroPRO.
2.2
Using the MiniSpir
For correct use of the device and for setup of data required for the interpretation of the results (initial setup, turbine calibration,
patient data management, viewing previous data and interpretation of results) see the winspiroPro software manual.
2.3
Spirometry Testing
WARNING
The device must only be used by qualified personnel with complete knowledge of spirometry; this is important for the
correct execution of the tests, for the acceptability of measured parameters as well as for the correct interpretation of
results.