MIR Spirodoc - 2. HARDWARE DESCRIPTION

Spirodoc
Page 6 of 39
Rev.1.5
Service Guide
Weight
Central unit 99g (including batteries)
Turbine housing 17g
Volume range
10 L
Flow range
± 16 L/s
Volume accuracy
± 3% or 100 mL
Flow accuracy
± 5% or 250 mL/s
Dynamic resistance at 12 L/s
< 0,5 cmH
2
O/L/s
Type of electrical protection
Class II device
Level of protection against direct or indirect contact
Category BF apparatus
Level of water ingress protection
IPX1 device, protected against water drops
Level of assurance of use in the presence of an anaesthetic
mix flammable with air or oxygen or protoxide of nitrogen
Apparatus not suitable
Conditions of use
Apparatus for repeated use
Storage conditions
Temperature: MIN -20 °C, MAX +60 °C
Humidity: MIN 10% RH; MAX 95%RH
Operating conditions
Temperature: MIN +10 °C, MAX +40 °C
Humidity: MIN 10% RH; MAX 95%RH
1.3.1.2. Battery charger
Battery charger supply: Voltage = 5VDC, Current = 1300 mA
Permissible mains voltage var.: 100 V-240 V
Mains frequency: 50 – 60 Hz
Max. current: 1300 mA at 5 VDC
1.4. STANDARDS APPLIED
 According to rule 10 of the European directive 93/42/CEE the device is classified as Class IIa
 EN 60601-1 Electronic medical apparatus. Part 1: General safety standards
 EN 60601-1-1 Electronic Medical apparatus. Part 1: General safety standards 1. Collateral standard: Safety requirements
for medical electronic systems
 EN 60601-1-2 Electronic medical apparatus. Part 1: General safety standards 2. Collateral standard: Electromagnetic
compatibility – Requirements and tests
 EN 60601-1-4 Electronic medical apparatus. Part 1: General safety standards 4. Collateral standards: Programmable
medical electronic systems
 UNI CEI EN ISO 14971 Medical devices: application of risk management to medical devices
 ATS/ERS TASK FORCE: Standardisation of lung function testing (volume 26/numbers 1-5/2005)
 Health Canada Medical Device Regulation: P.C. 1998-783 del 7 /5/1998
 SANS 451:2008 Spirometry — Generation of acceptable and repeatable spirograms FDA Regulations
 Japanese MHLW Ministerial Ordinance 169: 2004
2. HARDWARE DESCRIPTION
Because of the modular design of the spirodoc, the description is on a block diagram level.
BLOCK DIAGRAM