25
Design Limits: 50
– 104° F
Operating Humidity Range
30% - 75%
Ambient Pressure Range
850hPa
– 1060hPa
Performance Standards the Micro
Spirometer meets or exceeds
ATS/ERS 2019, ISO 23747:2015 &
ISO 26782:20009
Electrical Safety Standards
EN 60601-1:2006 + A1:2013
EMC Standards
EN 60601-1-2:2015 + A1:2021
Home Use Standard
EN 60601-1-11:2015
Coexistence Standard
ANSI C63.27-2017
QA/GMP Standards
EN ISO 13485, FDA 21 CFR 820,
CMDR SOR/98-282 & JPAL
Dimensions
~ 5.6
” x 3.2” x 1”
Weight
~ 9 ounces (device only, no batteries,
packaging or accessories)
Communications
USB 2.0
Bluetooth 2/4
Power Supply
5V DC via USB
4 x 1.5V AAA batteries (6V)
Essential Performance
Flow measurement output
Essential Performance Test Limits
Flow accuracy ±10% or ±10 L/min with
±3% or 3 L/min allowed for test
apparatus (ISO 23747)
Service Life
The recommended service life of the
device is 10 years+ or when the
product life checks dictate it is required.
The battery life of the RTC battery is
expected to exceed the device product
life. Reference section 8.2 Product
Useful Life Checks.
Product Life
10 years+ when maintenance
procedures are adhered to.
Reference section 8.2 Product Useful
Life checks
’ for information on how to
ascertain whether the device or parts
on the device have exceeded their
useful life and a service is required.
Minimum PC System Requirements
Processor Speed: 2GHz or greater
RAM: 2GB (min), 4GB (recommended)
Disk Space: 1GB or greater
Operating Systems: Windows® 10 or
above
Monitor: 1280 x 800 pixel
