Monitored Therapeutics GoSpiro Spirometer User manual

Monitored Therapeutics, Inc. © Copyright 2020 1 P/N 45-50035 Rev. K, 2020-10-21
GoSpiro®Spirometer
(Model Number 45-90058)
INSTRUCTIONS FOR USE
Rx Only
Distributed by:
Monitored Therapeutics, Inc.
5995 Shier Rings Rd., Suite A
Dublin, OH 43016 USA
Phone [phone]
www.monitoredrx.com
Manufactured for:
12th Man Technologies, Inc.
7245 Garden Grove Blvd., Suite C
Garden Grove, CA 92841 USA
1.714.705.4578
Made in the UK

Monitored Therapeutics, Inc. © Copyright 2020 2 P/N 45-50035 Rev. K, 2020-10-21
Contents
1. INTRODUCTION...................................................................................................................................................4
2. INDICATION FOR USE .........................................................................................................................................4
3. PACKAGE CONTENTS..........................................................................................................................................5
4. DESCRIPTION OF GOSPIRO ................................................................................................................................ 5
5. WARNINGS AND CAUTIONS ...............................................................................................................................6
6. CONTRAINDICATIONS.........................................................................................................................................8
7. ENVIRONMENT ...................................................................................................................................................8
8. GETTING STARTED .............................................................................................................................................9
9. PAIRING YOUR GOSPIRO®WITH A GOHOME™AND/OR SMARTPHONE ......................................................10
10. PERFORMING TESTS.........................................................................................................................................11
11. BATTERY MANAGEMENT .................................................................................................................................12
12. CALIBRATION....................................................................................................................................................13
13. CLEANING..........................................................................................................................................................13
14. HIGH LEVEL DISINFECTION.............................................................................................................................15
15. ACCESSORIES ....................................................................................................................................................15
16. MAINTENANCE .................................................................................................................................................16
17. SERVICING.........................................................................................................................................................16
18. WARRANTY AND LIABILITY.............................................................................................................................17
19. TROUBLE SHOOTING INFORMATION...............................................................................................................18
20. ELECTROMAGNETIC COMPATIBILITY..............................................................................................................19
21. BLUETOOTH®WIRELESS COMMUNICATION ..................................................................................................21
22. SYMBOLS ...........................................................................................................................................................21
23. SPECIFICATIONS ...............................................................................................................................................23
24. QUICK START ASSEMBLY GUIDE .....................................................................................................................25
25. QUICK START TESTING GUIDE ........................................................................................................................26
26. QUICK START CHARGING GUIDE .....................................................................................................................27
27.QUICK START CLEANING GUIDE .....................................................................................................................28

Monitored Therapeutics, Inc. © Copyright 2020 3 P/N 45-50035 Rev. K, 2020-10-21
Contents of Figures
FIGURE 1. GOSPIRO PACKAGE CONTENTS………………………………………………………….….5
FIGURE 2. PHYSICAL DESCRIPTION OF GOSPIRO DEVICE………………………………………….….5
FIGURE 3. INSERT TRANSDUCER FOR RIGHT HAND USE………………………………………..….….9
FIGURE 4. INSERT TRANSDUCER FOR LEFT HAND USE……………………….……………….….......10
FIGURE 5. PLUG GOSPIRO ONTO CHARGING STATION…………………………………………....…. .12
FIGURE 6. PLUG USB CABLE INTO USB PORT OF COMPUTER OR USB POWER SOURCE……….....…. 12
FIGURE 7. REMOVE MOUTHPIECE ADAPTER AND SOAK…………………………………………..…. 13
FIGURE 8. REMOVAL OF TRANSDUCER IF YOU USE GOSPIRO WITH RIGHT HAND………………..….14
FIGURE 9. REMOVAL OF TRANSDUCER IF YOU USE GOSPIRO WITH LEFT HAND……………………...…14

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 12th 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

Monitored Therapeutics, Inc. © Copyright 2020 5 P/N 45-50035 Rev. K, 2020-10-21
3. PACKAGE CONTENTS
Figure 1 GoSpiro Package Contents
4. DESCRIPTION OF GOSPIRO
The GoSpiro Spirometer
includes GoSpiro Body,
Vertical Turbine Assembly, a
Charging Station and a
software App for your
smartphone.
The only control on the
GoSpiro is a power button
next to an LED status
indicator.
The charging station
includes a USB cable which
should be connected to a
USB power source
(computer or USB charging
adapter). The charging
station is keyed to assure
alignment of the GoSpiro
with its charging connection.
Figure 2 Physical Description of GoSpiro Device

Monitored Therapeutics, Inc. © Copyright 2020 6 P/N 45-50035 Rev. K, 2020-10-21
5. WARNINGS AND CAUTIONS
WARNING: Messages that alert you to conditions that could place the patient or
operator at risk.
CAUTION: Messages that alert you to conditions that may result in damage to
equipment.
CAUTION: Read the manual before use
WARNING: The instrument is not suitable for use in the presence of explosive or
flammable gases, flammable anesthetic mixtures or in oxygen rich environments.
WARNING: Medical electrical equipment needs special precautions regarding
electromagnetic compatibility (EMC) and needs to be installed and put into service
according to the EMC information provided in the accompanying documents.
Electromagnetic interference can affect the accuracy of the GoSpiro measurements.
WARNING: Portable and mobile radio frequency (RF) communications equipment
can affect the transmission of data from medical electrical equipment. Do not use the
GoSpiro in the presence of external radio equipment.
WARNING: Keep GoSpiro away from strong sources of magnetic and RF fields,
such as large electric motors, amateur radio transmitters, radar, anti-theft systems
(including demagnetizers), stereo speakers, cell phone, and radio frequency
identification (RFID). Note that the presence of RFID may not be obvious. Be
aware that television and radio transmitters could cause interference if the device
is used close to them.
WARNING: The accuracy performance of GoSpiro can be affected by the patient
spitting or coughing into GoSpiro during expiration without use of a filter. Do not use
without the filter provided. Accuracy can also be affected by extremes of temperature,
humidity and altitude. Do not use or store in temperatures that exceed those listed in
these instructions.
WARNING: The accuracy performance of the GoSpiro can be affected if the bottom
of the GoSpiro is exposed to a strong light source while operating the spirometer. Do
not expose to bottom of the GoSpiro to a strong light source.
WARNING: The mouthport filter and/or mouthport adapter must only be used on a
single patient. Replace the filter in accordance with the instructions that come with it.
Use by more than a single patient can cause transmission of infectious material. Be
certain to purchase an adequate supply of filters that matches the number of tests you
were told to perform and the frequency of filter changes.
WARNING: Do not attempt to perform any service or any modifications of this
equipment.

Monitored Therapeutics, Inc. © Copyright 2020 7 P/N 45-50035 Rev. K, 2020-10-21
WARNING: Do not use accessories not described in this manual.
WARNING: It is unsafe to interconnect this GoSpiro device to other equipment not
described in this manual.
CAUTION: Do not force the turbine beyond the 90 degree position when inserting or
removing the turbine from the GoSpiro housing as it can break the locking tabs. Note
the direction of insertion and removal for left or right hand use. See Section 8
Getting Started for more information.
CAUTION: The charging station is keyed to assure alignment of the GoSpiro with its
charging connection. Do not force the GoSpiro into the charging station.
WARNING: Avoid exposing the GoSpiro to direct sunlight, dusty conditions, damp
environments, heating appliances or radiators as these conditions can affect the
performance or the life expectancy of the GoSpiro.
WARNING: Do not use the GoSpiro in a moving vehicle. Use in a moving vehicle
may result in inaccurate results.
WARNING: Only IEC 60601-1 or IEC 60950-1 certified products should be used with
the GoSpiro charging station or for data collection.
CAUTION: Keep the GoSpiro dry. The limited Ingress Protection (IP22) rating of the
GoSpiro case will not prevent damage from water making contact with case, leaking
into the case and damaging the electronics.
CAUTION: Children under the age of 10 may require parental assistance to perform
tests or operate a tablet or smartphone application.
PLEASE NOTE: The product you have purchased should not be disposed of as
unsorted waste. Please utilize your local EPA or WEEE collection facilities for the
disposal of this product.
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
WARNING: If the GoSpiro is used for more than one patient without a mouthport
filter, the turbine assembly should be replaced or undergo high level disinfection before
use on another patient to prevent infection.
WARNING: Medication decisions should be only under the direction of a physician.
WARNING: The GoSpiro should not be used for more than an accumulated use of 24
hours (approximately 1400 testing sessions) on a single patient. It is expected that the
GoSpiro will typically be used about 1 time per week for 1 minute per testing session.

Monitored Therapeutics, Inc. © Copyright 2020 8 P/N 45-50035 Rev. K, 2020-10-21
CAUTION: ATS/ERS recommendations indicate that all spirometers used in
laboratories be calibrated or have the calibration verified daily.
6. CONTRAINDICATIONS
WARNING: Do not use the GoSpiro if you have any of the following unless your
physician has cleared you to perform forced exhaled lung function measurements.
Failure to obtain approval from your physician if you have any of these could
result in serious injury or death:
6.1. Hemoptysis (coughing up blood) of unknown origin
6.2. Presence of a pneumothorax (collapsed lung)
6.3. Presence of unstable cardiovascular status:
6.3.1. Recent (within one month) myocardial infarction (heart attack)
6.3.2. Uncontrolled hypertension (high blood pressure)
6.3.3. Pulmonary embolism (blood clot in your lungs)
6.3.4. History of a hemorrhagic cerebrovascular event (stroke)
6.3.5. Unstable angina (chest pain)
6.4. Recent thoracic (chest), abdominal or eye surgery (2 weeks)
6.5. Nausea, vomiting or abdominal pain
6.6. Thoracic or abdominal aneurysms (weak blood vessels in your chest or
abdomen)
6.7. History of syncope (fainting) associated with forced exhalation
6.8. Active tuberculosis or Hepatitis B
7. ENVIRONMENT
7.1. Operating Environment
7.1.1. GoSpiro is designed for use in physician’s offices, clinics and in home
settings .
7.1.2. Use in temperatures outside the range of 17°C to 35°C (63°F to 95°F), should
be avoided.
7.1.3. GoSpiro is designed to operate at altitudes from sea level up to 2588 meters
(8491 feet). Use in altitudes outside the range should be avoided.
7.1.4. GoSpiro is intended to be used indoors only. Use in humid environments
outside the range of 30%RH to 75%RH, non-condensing, and ambient
pressure outside the range of 700hPa to 1060hPa, should be avoided.
7.1.5. The environment must be free of excessive vibrations, and sources of
electrical noise.
7.2. Transport/Storage Environment
7.2.1. The GoSpiro must only be transported or stored in the temperature range of
-20°C to 70°C (4°F to 158°F).

Monitored Therapeutics, Inc. © Copyright 2020 9 P/N 45-50035 Rev. K, 2020-10-21
7.2.2. The GoSpiro must be only exposed to relative humidity levels between
15%RH to 95%RH (50hPa maximum), non-condensing.
8. GETTING STARTED
8.1. The GoSpiro is designed to enable two different mouthport positions for holding
by either right or left handed individuals.
8.2. If you use your right hand to hold the GoSpiro, install the Turbine Assembly as
following (steps showing in Figure 3):
8.2.1. Insert the Turbine Assembly into the body of the GoSpiro with its mouthport
in the direction away from of the purple power button.
8.2.2. Turn the turbine assembly clockwise 90° and it will click-lock in place.
Caution: Do not force the turbine beyond the 90 degree position when inserting or
removing the turbine from the GoSpiro housing. Note the direction of insertion and
removal for left or right hand use.
Figure 3 Insert transducer for right hand use
8.3. If using your left hand to hold the GoSpiro is more comfortable for you, install the
Turbine Assembly as following (steps showing in Figure 4):
8.3.1. Insert the Turbine Assembly into the body of the GoSpiro with its mouthport
towards the purple power button.
8.3.2. Turn the turbine assembly clockwise 90° and it will click-lock in place.
Caution: Do not force the turbine beyond the 90 degree position when inserting or
removing the turbine from the GoSpiro housing. Note the direction of insertion and
removal for left or right hand use.

Monitored Therapeutics, Inc. © Copyright 2020 10 P/N 45-50035 Rev. K, 2020-10-21
Figure 4 Insert transducer for left hand use
8.4. If using the GoSpiro for more than one patient, it is mandatory that a new filter is used to
prevent cross contamination between patients.
9. PAIRING YOUR GOSPIRO®WITH A GOHOME™AND/OR SMARTPHONE
Your GoSpiro should have been paired with your smartphone already. If your GoSpiro
has not already been paired (the communications between them set up), then you
need to follow the steps in section 9.1. If your GoSpiro has been paired already,
proceed to Section 10, Performing Tests. Also read the GoSpiro App Quick Start Guide
for displaying and transmitting your data that came with your GoSpiro.
WARNING: Only IEC 60601-1 or IEC 60950-1 certified products should be
used with the GoSpiro charging station or for data collection.
9.1. Pairing the GoSpiro with a data collection device
9.1.1. Ensure that the GoSpiro is turned OFF (no LED is lit).
9.1.2. Select the “GoSpiro Setup” option on your smartphone.
9.1.3. Press and hold the GoSpiro’s purple power button for at least 6 seconds.
The buzzer will sound for 2 seconds and the LED on the GoSpiro will
light up PURPLE.
9.1.4. Following the instructions on the screen, press the “OK” button on the
screen.
9.1.5. The smartphone will now scan for the GoSpiro, locate it, and configure
it. Press the “DONE” button and then the GoSpiro will turn off.
9.1.6. After the pairing process, every next time you power on your GoSpiro
and select the GoSpiro App, it will flash its LED in blue, showing that it is
now searching for a device it’s already been paired with. If the data
collection device is nearby, GoSpiro will build the connection in 4 to 5
seconds and then its LED will turn solid blue, and there will be a short
beep of the buzzer, then you could use your GoSpiro to perform tests.