Monitored Therapeutics GoSpiro Spirometer Instructions For Use Manual
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Monitored Therapeutics GoSpiro Spirometer Instructions For Use Manual

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Distributed by:
Monitored Therapeutics, Inc.
5995 Shier Rings Rd., Suite A
Dublin, OH 43016 USA
Phone 1.614.761.3555
www.monitoredrx.com
Monitored Therapeutics, Inc. © Copyright 2020
GoSpiro
®
(Model Number 45-90058)
I
NSTRUCTIONS
Rx Only
Spirometer
F
U
OR
SE
1
P/N 45-50035 Rev. K, 2020-10-21
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

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Summary of Contents for Monitored Therapeutics GoSpiro Spirometer

  • Page 1 5995 Shier Rings Rd., Suite A 7245 Garden Grove Blvd., Suite C Dublin, OH 43016 USA Garden Grove, CA 92841 USA Phone 1.614.761.3555 1.714.705.4578 www.monitoredrx.com Made in the UK Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 2: Table Of Contents

    ........................25 UICK TART SSEMBLY UIDE 25. Q ........................26 UICK TART ESTING UIDE 26. Q ........................27 UICK TART HARGING UIDE 27. Q ........................28 UICK TART LEANING UIDE Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...
  • Page 3 OUTHPIECE DAPTER AND ………………..…. 14 8. R IGURE EMOVAL OF RANSDUCER IF YOU USE PIRO WITH IGHT ……………………...…14 9. R IGURE EMOVAL OF RANSDUCER IF YOU USE PIRO WITH Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 4: Introduction

    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.

  • Page 5: Package Contents

    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 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 6: Warnings And Cautions

    WARNING: Do not attempt to perform any service or any modifications of this equipment. Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...
  • Page 7 (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 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 8: Contraindications

    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 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 9: Etting Tarted

    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 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 10: Airing Your Piro With Aome And Or Martphone

    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. Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 11: Performing Tests

    ERFORMING ESTS The GoSpiro spirometer transmits real-time lung function data and diagnostic quality indices to computers, tablets or smartphones running GoSpiro compatible data collection software. The GoSpiro transmission interface is via a Bluetooth connection. The GoSpiro performs full flow- volume loops including inspiratory and expiratory data. The internal...

  • Page 12: Battery Management

    11.3.1. Following 300 cycles of charging, the charge capacity of the battery will remain above 80% of the initial capacity. 11.3.2. On a single battery charge the GoSpiro can perform at least 140 measurements. Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 13: Calibration

    If performance errors are confirmed, the GoSpiro should be returned to Monitored Therapeutics for servicing and recalibration. CAUTION: ATS/ERS recommendations indicate that all spirometers used in laboratories be calibrated or have the calibration verified daily.
  • Page 14 13.4. Visually check parts to see that they are free of any visible soil or build-up. If any is seen, repeat the cleaning steps. 13.5. Re-assemble the transducer into the GoSpiro housing by reversing the steps shown for disassembly. Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 15: High Level Disinfection

    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. Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 16: Maintenance

    1.614.761.3555 if your GoSpiro requires service, repair or if you need technical assistance. Before returning your product to Monitored Therapeutics, first obtain a Returned Goods Authorization (RGA) number. No product should be returned to Monitored Monitored Therapeutics, Inc. © Copyright 2020...

  • Page 17: Warranty And Liability

    The GoSpiro hardware is guaranteed against manufacturing defects for 2 years. Monitored Therapeutics, Inc. tests to ensure that the internal software meets the specification given in the product literature; it does not warrant that the software supplied in this package is suitable for your specific requirements or usage.

  • Page 18: Trouble Shooting Information

    If the LED indicator is in a wrong color or flashing pattern other than listed below, do not try to fix it yourself. Contact info@monitoredRx.com call 1.614.761.3555 for technical assistance. Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 19: Lectromagnetic Ompatibility

    Guidance and manufacturer’s declaration – electromagnetic emissions The GoSpiro Spirometer is intended for use in the electromagnetic environment specified below. The customer or the user of the GoSpiro Spirometer should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 20 RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the GoSpiro Spirometer is used exceeds the applicable RF compliance level above, the GoSpiro Spirometer should be observed to verify normal operation.

  • Page 21: Bluetooth ® Wireless Communication

    CAUTION: Messages that alert you to conditions that may result in damage to equipment. CAUTION: Read the accompanying documents WARNING: Messages that alert you to conditions that could place the patient or operator at risk. Manufacturer Serial number Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...
  • Page 22 The CB Scheme utilizes CB Test Certificates to attest that the GoSpiro has successfully passed the test conditions and are in compliance with the requirements of the relevant IEC Standard(s). Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 23: Specifications

    ±3% of reading, or 0.05 liters, whichever is greater. Volume measurements are at BTPS Volume Accuracy conditions Maximum Volume 8 liters maximum Flow Accuracy ±5% of reading, or 200 mL/sec, whichever is greater. Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...
  • Page 24 300 g Operating Conditions 17°C to 35°C, 30%RH to 75%RH, non-condensing, 70kPa to 106kPa Transport and Storage Conditions -20°C to 70°C, 15% to 95% RH, non-condensing Service Interval 2 years Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 25: Quick Start Assembly Guide

    UICK TART SSEMBLY UIDE Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 26: Quick Start Testing Guide

    UICK TART ESTING UIDE Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 27: Quick Start Charging Guide

    UICK TART HARGING UIDE Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

  • Page 28: Quick Start Cleaning Guide

    UICK TART LEANING UIDE Monitored Therapeutics, Inc. © Copyright 2020 P/N 45-50035 Rev. K, 2020-10-21...

This manual is also suitable for:

45-90058Gospiro 45-90058

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