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Monitored Therapeutics GoSpiro Spirometer - User Manual

Monitored Therapeutics GoSpiro Spirometer
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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 1.614.761.3555
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

Questions and Answers

Summary

Introduction and Assistance

Assistance Contact Information

Contact information for further assistance and support regarding the GoSpiro device.

GoSpiro Device Description and Package Contents

Package Contents Overview

Lists the essential components included with the GoSpiro Spirometer.

GoSpiro Device Components

Details the physical components of the GoSpiro spirometer and its accessories.

Charging Station Connection

Explains the USB cable connection for the charging station to a power source.

Safety Warnings and Cautions

General Risk and Damage Alerts

Alerts to conditions posing risks to patients/operators or causing equipment damage.

Manual Reading Advisory

Advises users to read the manual thoroughly before operating the device.

Hazardous Environment Warning

Warns against using the instrument in environments with explosive or flammable gases.

Electromagnetic Compatibility Precautions

Highlights safety precautions related to electromagnetic compatibility (EMC).

Radio Frequency Interference Warning

Warns about interference from portable and mobile RF communication equipment.

Magnetic and RF Field Proximity Warning

Advises keeping the GoSpiro away from strong magnetic and RF field sources.

Accuracy Impact: Spitting or Coughing

Warns that accuracy can be affected by patient spitting or coughing without a filter.

Accuracy Impact: Strong Light Exposure

Warns that accuracy can be affected by exposure to strong light sources.

Infection Control: Single Patient Use

Stresses single-patient use for mouthport filter/adapter to prevent infection.

Equipment Modification Prohibition

Prohibits attempting any service or modifications to the equipment.

Unapproved Accessory Warning

Advises against using accessories not explicitly described in the manual.

Unsafe Interconnection Warning

Warns against interconnecting the GoSpiro with unlisted equipment.

Turbine Handling Caution

Caution regarding forcing the turbine beyond 90 degrees during insertion/removal.

Charging Alignment Caution

Caution about the charging station's keyed alignment and not forcing connection.

Environmental Exposure Warning

Warns against exposing the GoSpiro to adverse environmental conditions.

Moving Vehicle Usage Prohibition

Prohibits using the GoSpiro in a moving vehicle due to potential inaccuracies.

Certified Product Requirement

Specifies the use of IEC 60601-1 or IEC 60950-1 certified products.

Water Ingress Protection Caution

Caution about keeping the GoSpiro dry due to its IP22 rating.

Child User Assistance Advisory

Notes that children under 10 may need parental assistance for operation.

Proper Product Disposal

Advises proper disposal of the product via local EPA or WEEE facilities.

Physician Prescription Requirement

States that Federal Law restricts device sale to physician's prescription.

Multi-Patient Use Infection Control

Addresses infection control for multi-patient use without a filter.

Physician-Directed Medication Decisions

Emphasizes that medication decisions must be physician-directed.

Usage Time Limit Warning

Warns against exceeding 24 hours of accumulated use on a single patient.

Contraindications and Environment

Contraindication Advisory

Warns against use if certain medical conditions exist without physician clearance.

Hemoptysis Contraindication

Contraindication: Coughing up blood of unknown origin.

Pneumothorax Contraindication

Contraindication: Presence of a pneumothorax (collapsed lung).

Unstable Cardiovascular Status Contraindications

Contraindication: Presence of unstable cardiovascular status.

Recent Heart Attack Contraindication

Contraindication: Recent myocardial infarction (heart attack).

Uncontrolled Hypertension Contraindication

Contraindication: Uncontrolled hypertension (high blood pressure).

Pulmonary Embolism Contraindication

Contraindication: Pulmonary embolism (blood clot in lungs).

Stroke History Contraindication

Contraindication: History of cerebrovascular event (stroke).

Unstable Angina Contraindication

Contraindication: Unstable angina (chest pain).

Recent Surgery Contraindication

Contraindication: Recent thoracic, abdominal, or eye surgery (within 2 weeks).

Nausea;Vomiting;Pain Contraindication

Contraindication: Nausea, vomiting, or abdominal pain.

Aneurysm Contraindication

Contraindication: Thoracic or abdominal aneurysms.

Syncope History Contraindication

Contraindication: History of syncope associated with forced exhalation.

Infectious Disease Contraindications

Contraindication: Active tuberculosis or Hepatitis B.

Operating Environment Details

Specifies the recommended operating environment for the GoSpiro.

Temperature Operating Limits

Advises avoiding operation outside the temperature range of 17°C to 35°C.

Altitude Operating Limits

Specifies the operational altitude range from sea level up to 2588 meters.

Indoor Use Requirement

States that the GoSpiro is intended for indoor use only.

Environmental Quality Requirements

Requires the environment to be free of excessive vibrations and electrical noise.

Transport and Storage Environment

Details the recommended environment for transporting and storing the GoSpiro.

Temperature Transport;Storage Limits

Specifies the temperature range for transport and storage: -20°C to 70°C.

Humidity Exposure Limits

Specifies humidity limits for exposure: 15%RH to 95%RH, non-condensing.

Getting Started: Assembly and Pairing

Mouthport Positioning for Handedness

Notes the GoSpiro's design for two mouthport positions for right/left handed use.

Turbine Assembly: Right Hand Use

Instructions for installing the Turbine Assembly for right-hand use.

Turbine Insertion Caution

Caution against forcing the turbine beyond 90 degrees during insertion/removal.

Turbine Assembly: Left Hand Use

Instructions for installing the Turbine Assembly for left-hand use.

Filter Usage for Multi-Patient Testing

Mandatory use of a new filter for each patient to prevent cross-contamination.

Pairing GoSpiro with Data Device

Step-by-step guide for pairing the GoSpiro with a data collection device.

Pairing: Ensure GoSpiro is Off

First step in pairing: Ensure the GoSpiro is powered off.

Pairing: Select GoSpiro Setup

Second step in pairing: Select 'GoSpiro Setup' on the smartphone.

Pairing: Press and Hold Power Button

Third step in pairing: Press and hold the power button for 6 seconds.

Pairing: Follow On-Screen Prompts

Fourth step in pairing: Follow on-screen instructions and press 'OK'.

Pairing: Device Scan and Configuration

Fifth step in pairing: Smartphone scans, locates, and configures the GoSpiro.

Post-Pairing GoSpiro Behavior

Describes GoSpiro's LED behavior and connection process after successful pairing.

Performing Spirometry Tests

Test Data Transmission Overview

Explains how the GoSpiro transmits lung function data via Bluetooth.

Accuracy Warning: Light Exposure During Tests

Warns about light affecting accuracy during spirometer operation.

Test Preparation: Attach Filter

Step to attach the user-supplied filter to the GoSpiro mouthport.

Test Preparation: Select GoSpiro App

Step to select the GoSpiro App on the smartphone.

Test Preparation: Power On GoSpiro

Step to power on the GoSpiro, indicated by a blinking blue LED.

Test Preparation: Confirm Pairing Status

Indicates successful pairing when the GoSpiro LED turns steady blue.

Accuracy Warning: Filter Use During Tests

Accuracy impact warning for spitting/coughing without a filter during tests.

Test Posture Instruction

Instruction to sit upright with feet flat on the floor for testing.

Test Setup: Nose Clip and Mouthpiece

Instructions for applying the nose clip and mouthpiece correctly.

Test Breathing Technique: Deep Inhalation

Instruction to take a deep breath to fill lungs to maximum capacity.

Test Breathing Technique: Forceful Exhalation

Instruction to exhale forcefully and continuously for at least six seconds.

Important Test Note: Avoid Breath Holding

Important note to avoid holding breath after inhalation before exhalation.

Test Completion: Remove Mouthpiece

Step to remove the filter port or adapter from the mouth after the test.

Test Completion and Data Transmission

Confirms test completion and data transmission.

Battery Management and Calibration

Battery Level Monitoring

Information on how to check and understand the GoSpiro's battery level.

Low Battery Shutdown Behavior

Describes GoSpiro shutdown behavior when battery level is below 5%.

GoSpiro Charging Procedure

Instructions for charging the GoSpiro device.

Charging: Connect to Station

Step to place the GoSpiro onto the charging station for charging.

Charging Caution: Alignment

Caution regarding the keyed alignment of the charging station.

Charging Accessory Certification

Specifies certified products for use with the charging station.

Charging: Connect USB Power Source

Step to connect the charging station's USB cable to a power source.

Battery Information: Capacity and Lifespan

Provides information regarding battery lifespan and measurement capacity.

Battery Capacity After Charging Cycles

Battery capacity remains above 80% after 300 charging cycles.

Battery Capacity Per Charge

A single battery charge allows for at least 140 measurements.

Battery Replacement Protocol

Battery replacement must be performed only by a factory-trained technician.

GoSpiro Calibration and Servicing

States the GoSpiro is factory calibrated and requires servicing every two years.

Calibration Verification Recommendation

Notes ATS/ERS recommendations for daily calibration verification in labs.

GoSpiro Device Cleaning

Instructions for cleaning the GoSpiro device case with a damp cloth.

Mouthport Adapter Cleaning

Procedure for cleaning the mouthport adapter after each single-patient use.

Mouthport Adapter Soaking Instructions

Details soaking the mouthport adapter in detergent solution for ten minutes.

Clinic;Office Cleaning Procedures

Cleaning the GoSpiro case with a damp cloth or disinfectant wipe in offices.

Single-Use Accessory Disposal

Mouthport adapter/filter are single-use and should be discarded after each use.

Cleaning, Disinfection, and Accessories

Turbine Transducer Cleaning Procedure

Procedure for cleaning the turbine transducer if deemed necessary.

Turbine Transducer Removal

Steps for removing the turbine transducer by rotating and pulling.

Multi-Patient Filter;Adapter Use Warning

Reiterates single-patient use for mouthport filter/adapter to prevent infection.

Water Ingress Caution for Transducer

Caution regarding keeping the GoSpiro dry due to its IP22 rating.

Transducer Immersion Cleaning

Details immersion of transducer in detergent solution for cleaning.

Transducer Post-Cleaning Rinse and Dry

Instructions for rinsing the transducer with distilled water and air drying.

Post-Cleaning Part Inspection

Step to visually inspect parts for soil/build-up after cleaning.

Transducer Reassembly

Instructions for reassembling the transducer into the GoSpiro housing.

High Level Disinfection Procedure Context

Context for high-level disinfection of the turbine for multiple patients without a filter.

Pre-Disinfection Cleaning Step

Instruction to follow cleaning steps from Section 13 before disinfection.

Turbine Soaking for Disinfection

Details soaking the turbine in Metricide™ (glutaraldehyde) for 45 minutes.

Post-Disinfection Rinse and Dry

Rinsing and air drying the transducer after high-level disinfection.

Reassembly After Disinfection

Reassembling the transducer after disinfection procedures.

Accuracy Verification Post-Disinfection

Verifying or calibrating the GoSpiro for accuracy after disinfection.

Recommended Accessories Overview

Lists recommended replaceable accessories for the GoSpiro spirometer.

Nose Clip Accessory Details

Details the Nose Clip accessory and its part number; substitution is allowed.

Nose Clip Usage Instructions

Instruction to squeeze the Nose Clip to open its foam pads.

Nose Clip Positioning Guide

Guidance on correctly positioning the Nose Clip on the nose.

Nose Clip Removal

How to remove the Nose Clip from the nose.

Mouthport Filter Specifications

Specifies the required type and certification for the Mouthport filter.

Mouthport Filter: Single-Use

States that the Mouthport filter is single-use and not to be cleaned.

Compatible Filter Sources

Provides information on where to obtain compatible filters from A-M Systems.

Example Compatible Filter

Example of a compatible filter: VBMAX30E with catalog number 146300.

Mouthport Adapter Accessory Details

Details the Mouthport Adapter accessory and its part number.

Mouthport Adapter Functionality

Explains the mouthport adapter's connection and protective screen function.

Mouthport Adapter Limitations

States the adapter does not filter microbes and is for single-person use.

Accessory Purchasing Information

Contact information for pricing and purchasing accessories.

Maintenance, Servicing, and Warranty

GoSpiro Maintenance Overview

Overview of the GoSpiro's low maintenance design and precautions.

Preventive Maintenance: Turbine Replacement

Recommendation to replace the Turbine Assembly every 12 months for preventive maintenance.

Maintenance: Turbine Exposure to Dust

Instructs to follow cleaning procedures in Section 13 if Turbine Assembly is exposed to dust.

Post-Use Mouthport Adapter Cleaning

Instruction to clean the mouthport adapter after every use.

Servicing: Calibration and Transducer Care

Routine servicing includes calibration checks every two years and transducer cleaning.

Servicing Schedule: Factory Return

GoSpiro must be returned to the factory every 2 years for inspection and accuracy checks.

Technical Assistance Contact

Contact details for service, repair, or technical assistance.

Return Procedure: RGA Number

Procedure to obtain a Returned Goods Authorization (RGA) number before returning the product.

No User-Serviceable Parts Advisory

States there are no user-serviceable parts and adherence to warranty policy.

Warranty Period: Hardware Defects

GoSpiro hardware is guaranteed against manufacturing defects for 2 years.

Software Warranty Limitations

States that software is tested but not warranted for specific user requirements.

Warranty Exclusions: Media and Documentation

Exclusions from warranty include damage to supplied media or documentation.

Warranty Exclusion: Computer Compatibility

No warranty is provided for software or communication protocol compatibility with user computers.

Liability Limitation for Damages

Limits liability for special, consequential, or indirect damages from product use or misuse.

Warranty Service: Software;Documentation

Contact email for requesting warranty service for software or documentation.

Troubleshooting and Electromagnetic Compatibility

Troubleshooting Guide Introduction

Provides a table to consult for troubleshooting common GoSpiro operating problems.

Troubleshooting: Power Button Issues

Scenario: Troubleshooting powering up the device by pressing the power button.

Troubleshooting: Pairing Device

Scenario: Troubleshooting pairing the GoSpiro with a data collection device.

Troubleshooting: Performing Tests

Scenario: Troubleshooting performing a test via a data collection app.

Troubleshooting: Test Completion Issues

Scenario: Troubleshooting after completing a test via a data collection app.

Troubleshooting: Non-Standard LED Indicators

Advice for incorrect LED indicators: contact support if issues persist.

Electromagnetic Emissions Guidance

Guidance and declaration regarding electromagnetic emissions from the GoSpiro.

Intended Electromagnetic Environment

Specifies the intended electromagnetic environment for GoSpiro use.

Electromagnetic Emissions Tests

Details tests related to electromagnetic emissions.

RF Emissions Compliance (CISPR 11)

Information on RF emissions testing according to CISPR 11.

Harmonic Emissions Compliance (IEC 61000-3-2)

Details harmonic emissions testing according to IEC 61000-3-2.

Voltage Fluctuations;Flicker Compliance

Information on voltage fluctuations and flicker emissions testing.

Electromagnetic Immunity Guidance

Guidance and declaration regarding electromagnetic immunity of the GoSpiro.

Immunity Test Categories

Details tests for electromagnetic immunity.

Electrostatic Discharge (ESD) Immunity

Information on electrostatic discharge (ESD) immunity testing.

Electrical Fast Transient;Burst Immunity

Details electrical fast transient/burst immunity testing.

Surge Immunity Testing

Information on surge immunity testing.

Voltage Variation Immunity

Details immunity testing for voltage dips, interruptions, and variations.

Power Frequency Magnetic Field Immunity

Information on power frequency magnetic field immunity testing.

Conducted RF Immunity Testing

Information on conducted RF immunity testing.

Radiated RF Immunity Testing

Details radiated RF immunity testing.

RF Equipment Separation Distances

Provides recommended separation distances for RF equipment to avoid interference.

EMC Separation Distance Calculation

Provides equations to estimate separation distance for transmitters not listed.

EMC: Unapproved Modification Warning

Warns that unapproved modifications can cause EMC issues.

Bluetooth Communication and Symbols

Bluetooth Technology Overview

Explains Bluetooth technology for short-distance data exchange.

Bluetooth Power and Range

Provides Bluetooth output power (2.5mW) and typical range (30 feet).

Bluetooth Function: Pairing and Data Transfer

Describes Bluetooth's role in pairing GoSpiro with devices and data transfer.

FCC Declaration of Conformity

FCC declaration of conformity for the GoSpiro device.

FCC Part 15 Compliance Statement

States the equipment complies with FCC Part 15 for Class B digital devices.

Symbol: Type BF Applied Part

Explains the Type BF applied part symbol for electrical shock protection.

Applied Parts Identification

Identifies the handheld device and turbine assembly as applied parts.

Symbol: Proper Disposal

Explains the symbol for proper disposal according to EPA/WEEE regulations.

Symbol: Caution (Equipment Damage)

Explains the 'Caution' symbol related to equipment damage.

Symbol: Caution (Read Documents)

Explains the 'Caution: Read accompanying documents' symbol.

Symbol: Warning (Risk)

Explains the 'Warning' symbol related to patient or operator risk.

Symbol: Manufacturer

Identifies the symbol for Manufacturer.

Symbol: Serial Number

Identifies the symbol for Serial Number (SN).

Symbol: Bluetooth Trademark

Defines the Bluetooth registered trademark symbol.

Bluetooth SIG Trademark Statement

States Bluetooth is a registered trademark of Bluetooth SIG, Inc.

Symbol: Reference Number

Identifies the symbol for Reference Number (REF).

IP22 Water Ingress Test Status

States GoSpiro passed the IP22 water ingress test.

Symbol: Radio-Frequency Interference

Explains the symbol indicating potential Radio-Frequency Interference.

Symbol: CNEMKOus Certification

Explains the CNEMKOus mark for US and Canadian market certification.

Symbol: CB Scheme Compliance

Explains the CB Scheme and CB Test Certificates for IEC standard compliance.

GoSpiro Specifications

Measured Respiratory Parameters

Lists the various respiratory parameters measured by the GoSpiro.

Technical Specifications Overview

Provides technical specifications for the GoSpiro's components and performance.

Transducer Type Specification

Specifies the type of transducer used in the GoSpiro.

Volume Accuracy Specification

Details the accuracy specifications for volume measurements.

Maximum Volume Capacity

States the maximum volume capacity of the GoSpiro.

Flow Accuracy Specification

Details the accuracy specifications for flow measurements.

Maximum Flow Rate

Specifies the maximum flow rate the GoSpiro can measure.

Flow Sensitivity Specification

Details the flow sensitivity of the GoSpiro.

Dynamic Impedance Specification

Provides the dynamic impedance measurement for the GoSpiro.

Recording Time Specification

Specifies the recording time for measurements.

Power Supply Requirements

Details the power supply requirements for the GoSpiro.

Battery Life Information

Provides information on the GoSpiro's battery life.

Operating Current Consumption

Specifies the operating current consumption of the GoSpiro.

GoSpiro Dimensions

Lists the physical dimensions of the GoSpiro device.

Charging Station Dimensions

Lists the physical dimensions of the GoSpiro Charging Station.

Weight Specification

Provides the weight of the GoSpiro, including the battery.

Operating Conditions Specification

Details the operational environmental conditions for the GoSpiro.

Transport and Storage Conditions

Specifies conditions for transporting and storing the GoSpiro.

Service Interval Recommendation

Indicates the recommended service interval for the GoSpiro.

Quick Start Guides: Assembly, Testing, Charging, Cleaning

Quick Start Assembly: Initiate

Initiates the quick start assembly process for the GoSpiro.

Quick Start Assembly: Unpack Components

Instructions to take out the Turbine Assembly and handheld device.

Assembly: Hand Preference Decision

Decision point on preferred hand for holding the GoSpiro.

Assembly: Left Hand Path

Path for assembling the GoSpiro for left-hand use.

Assembly: Right Hand Path

Path for assembling the GoSpiro for right-hand use.

Assembly: Turbine Insertion (Left;Right)

Step to insert the turbine assembly for left-hand use.

Assembly: Secure Turbine

Step to secure the turbine assembly by turning clockwise.

Assembly Caution: Turbine Force

Caution against forcing the turbine beyond 90 degrees during insertion/removal.

Assembly: Connect PFT Filter

Step to connect the PFT filter to the turbine assembly.

Assembly: Connect Mouthport Adapter

Step to connect the mouthport adapter to the PFT filter.

Assembly: Completion

Indicates the completion of the GoSpiro assembly process.

Quick Start Testing: Initiate

Initiates the quick start testing procedure for the GoSpiro.

Quick Start Testing: Power On

Instruction to quickly press the power button to start testing.

Quick Start Testing: LED Feedback

Explains LED behavior and troubleshooting for pairing issues during testing.

Quick Start Testing: Apply Nose Clip;Mouthpiece

Instructions for applying nose clip and mouthpiece for testing.

Quick Start Testing: Breathing Technique

Guidance on breathing technique during the test.

Quick Start Testing: Forceful Exhalation

Instruction for performing forceful exhalation during the test.

Quick Start Testing: Important Breathing Note

Important note to avoid holding breath after inhalation before exhalation.

Quick Start Testing: Test Completion Steps

Final steps to complete the test: inhale, remove mouthpiece.

Quick Start Testing: Finish

Indicates the completion of the quick start testing procedure.

Quick Start Charging: Initiate

Initiates the quick start charging guide for the GoSpiro.

Quick Start Charging: Connect to Station

Step to place the GoSpiro handheld device into its charging station.

Quick Start Charging: Connect Power Source

Step to connect the charging station's USB port to a power source.

Quick Start Charging: Time Estimates

Provides charging time estimates: at least 30 mins, 2-4 hours for full charge.

Quick Start Charging: Disconnect Device

Step to disconnect the GoSpiro device from the charging station.

Quick Start Charging: Finish

Indicates the completion of the quick start charging process.

Quick Start Charging Caution: Alignment

Caution regarding the keyed alignment of the charging station.

Quick Start Cleaning: Initiate

Initiates the quick start cleaning guide for the GoSpiro.

Quick Start Cleaning: Remove Adapter

Step to remove the adapter from the PFT filter port.

Quick Start Cleaning: Remove Filter

Step to remove the PFT filter from the GoSpiro mouthport.

Quick Start Cleaning: Filter Replacement

Instruction to change the filter based on manufacturer recommendations.

Quick Start Cleaning: Soak Adapter

Soaking the adapter in detergent solution for 10 minutes.

Quick Start Cleaning: Rinse and Dry Adapter

Rinsing the adapter with distilled water and air drying it.

Quick Start Cleaning: Inspect Parts

Visually inspect parts for soil/build-up and repeat cleaning if necessary.

Quick Start Cleaning: Finish

Indicates the completion of the quick start cleaning procedure.

Quick Start Cleaning Caution: Water Ingress

Caution about keeping the GoSpiro dry due to its IP22 rating.

Monitored Therapeutics GoSpiro Spirometer Specifications

General IconGeneral
Device TypeSpirometer
ManufacturerMonitored Therapeutics
ModelGoSpiro
Data ConnectivityBluetooth
Bluetooth Version4.0
Battery Life (Continuous Use)8 hours
Operating Temperature10°C to 40°C
Storage Temperature-20°C to 60°C
Weight150 g
Measurement Range (Flow)0 to 16 L/s
Resolution10 mL
Battery LifeUp to 7 days
PowerRechargeable lithium-ion battery
Accuracy±3% or 0.05 L, whichever is greater