Monitored Therapeutics GoSpiro Spirometer - Introduction and Assistance; Assistance Contact Information

Monitored Therapeutics, Inc. © Copyright 2020 4 P/N 45-50035 Rev. K, 2020-10-21
1. INTRODUCTION
Thank you for choosing the GoSpiro
®
Spirometer from Monitored Therapeutics. You
should have been trained on the use of the GoSpiro by your physician, healthcare
provider or their technical associate when you received this device. Please take the
time to familiarize yourself again with the instructions for use detailed in this
manual by reading the entire manual before use. Additional step-by-step pictures
are at the end of this manual.
ASSISTANCE:
For further information please refer to our website: www.monitoredrx.com. If
you need assistance using your GoSpiro, either contact the healthcare provider
who prescribed its use or contact Monitored Therapeutics at 1.614.761.3555.
The GoSpiro spirometer transmits real-time lung function data to computers, tablets
or smartphones over a Bluetooth connection for tele-healthcare applications. The
GoSpiro performs full flow-volume loops including inspiratory and expiratory data.
The internal program performs all of the calculations for measurements to meet
American Thoracic Society and European Respiratory Society requirements. It has
built-in quality control measurements and transmits indices of measurement quality
including time to peak flow, back-extrapolated volume, total expiratory time, end-
expiratory flow detection and identification of a cough during the measurement. No
data or graphics are displayed by the GoSpiro. Only your healthcare provider (HCP)
will have access to the data measured by the GoSpiro. Your HCP may give you
instructions and/or a display device to see some of your test results.
The GoSpiro is powered by a rechargeable Lithium battery and is charged via its USB
charging station connected to a USB power source.
This spirometer uses a vertical turbine volume sensor. The turbine transducer
measures expired air directly at B.T.P.S. (body temperature and pressure with
saturated water vapor) thus avoiding the inaccuracies of temperature corrections.
This transducer is insensitive to the effects of condensation and temperature and
avoids the need for individual calibration prior to performing a test.
GoSpiro
®
is a registered trademark of 12
th
Man Technologies, Inc. in the United
States.
2. INDICATION FOR USE
The GoSpiro
®
is intended to be used by adults and children over 5 years old in
physician’s offices, clinics and home settings to conduct basic lung function and
spirometry testing.
The GoSpiro should only be used by the person for whom it was prescribed.
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interferences,
and (2) this device must accept any interference received, including
interferences that may cause undesired operation.
FCC ID: A8TBM77SPPSYC2A