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Monitored Therapeutics GoSpiro Spirometer - High Level Disinfection Procedure Context; Pre-Disinfection Cleaning Step; Turbine Soaking for Disinfection; Post-Disinfection Rinse and Dry

Monitored Therapeutics GoSpiro Spirometer
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Monitored Therapeutics, Inc. © Copyright 2020 15 P/N 45-50035 Rev. K, 2020-10-21
WARNING: If the GoSpiro is used for more than one patient without a
mouthport filter, the turbine assembly must be replaced or undergo high
level disinfection before use on another patient to prevent infection.
14. HIGH LEVEL DISINFECTION
If the GoSpiro is being used for multiple patients and has been used without
a filter, the turbine must be replaced or undergo a high level disinfection as
follows:
14.1. Follow the cleaning steps in Section 13 prior to disinfection.
14.2. Soak the turbine in Metricide™ (glutaraldehyde) for 45 minutes.
14.3. After disinfections, the transducer must be completely rinsed in distilled
water and allowed to air dry.
14.4. Re-assemble the transducer into the GoSpiro housing by reversing the steps
shown for disassembly.
14.5. Perform and verification or calibration of the GoSpiro to confirm accuracy
performance.
15. ACCESSORIES
The following replaceable accessories are recommended for use with your
spirometer.
15.1. Nose Clip (Part Number 50-90059) Any available nose clip may be
substituted.
15.1.1. The Nose Clip is used with GoSpiro during testing.
15.1.2. Squeeze the Nose Clip to spread the foam pads.
15.1.3. Place the Nose Clip vertically on your nose so the pads sit on the outside
of each nostril.
15.1.4. Release the squeezing of the Nose Clip and it should seal your nasal
passages. Assure that no air exists through your nose. This will prevent
air leaking out of your nose that would not be captured by the sensor at
your mouth.
15.1.5. Squeeze the Nose Clip to release it from your nose.
15.2. Mouthport Filter (Part Number 45-90060)
15.2.1. The Mouthport filter must be a 30 mm, 510(k) cleared Pulmonary
Function Test filter. These can be purchased from Monitored
Therapeutics or other medical suppliers on the internet.
15.2.2. The Mouthport filter is a single-patient use device and should not be
cleaned.