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SpiroUSB Spirometer
Operating Manual
Federal (USA) law restricts this device to sale by or on the order of
a physician or licensed practitioner.
Micro Direct, Inc.
803 Webster Street
Lewiston, ME 04240
1-800-588-3381
www.mdspiro.com
075-11 US
Issue 1.6
February 2019
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Summary of Contents for Micro Direct SpiroUSB
- Page 1 SpiroUSB Spirometer Operating Manual Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner. Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240 1-800-588-3381 www.mdspiro.com 075-11 US Issue 1.6 February 2019...
- Page 2 Indications for Spirometry Spirometry has been used extensively to measure lung function capability and to recognize and treat many diseases associated with the impairment of healthy lung functions. Spirometry today provides great insight into the status of any person’s health. Generally speaking, spirometry is a simple diagnostic tool used to define a subject’s lung condition.
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Page 3: Table Of Contents
Warning and Cautions ............... - 3 - Indications for Use ..............- 5 - Installing SPCS ................- 5 - Installing SpiroUSB Device Driver ..........- 5 - Compatibility Status ..............- 5 - Driver installation ............... - 6 - Operation ................... -
Page 4: Introduction
Introduction The SpiroUSB is a PC connected spirometer dedicated to work with the comprehensive Spirometry PC Software (SPCS). SPCS is a fully Windows™ compatible spirometry system that interfaces seamlessly with the SpiroUSB providing many display options and includes powerful reporting and database facilities. -
Page 5: Package Contents
Package Contents The SpiroUSB is packaged in a sturdy carrying case containing this manual and the following items (Fig.1): 1. Digital Volume Transducer 2. SpiroUSB transducer housing. Together with SPCS, extension cable, disposable cardboard mouthpieces and nose clip. -
Page 6: Contraindications
Contraindications Contraindications: It is recommended that patients should not be tested within one month of a myocardial infarction. Conditions where suboptimal spirometry are likely: • chest or abdominal pain • oral or facial pain exacerbated by a mouthpiece • stress incontinence •... - Page 7 WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. CAUTION: When you connect the SpiroUSB to other equipment, always make sure that the whole combination complies with the international safety standard IEC 60601-1 for medical electrical systems.
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Page 8: Indications For Use
(18 to 99 years) patients in hospitals, physician offices, laboratories and occupational health testing environments. Installing SPCS SPCS is supplied on the CD ROM with your SpiroUSB. Install SPCS according to the instructions in the SPCS quick start guide. Installing SpiroUSB Device Driver... -
Page 9: Driver Installation
Micro Direct at 800-588-3381 to request a link for the drivers. Operation Simply connect the SpiroUSB to a spare USB port on your PC with the supplied SPCS installed. SPCS will automatically detect the SpiroUSB has been connected to a USB port and will run, ready for you to start your spirometry session. -
Page 10: Calibration Check
Note: Keep the PC and monitor out of reach of the patient at all times. Looking after your SpiroUSB Spirometer Please observe the following precautions: • Avoid exposing the SpiroUSB to direct sunlight during use. • Avoid operating the spirometer in dusty conditions or near to heating appliances or radiators. - Page 11 Pressing the ‘Verify Calibration’ button in the SPCS invokes the start of a device search and the option Calibration Check. The device search effectively scans the PC’s com/usb ports for any attached device. On finding a device, the screen will change to the main verify calibration test screen.
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Page 12: Cleaning Instructions
CAUTION: Unplug your SpiroUSB before cleaning. External Surfaces of the Spirometer CAUTION: Do not attempt to wash or immerse the SpiroUSB transducer housing in water or cleaning fluid as there are electronic components inside that will be permanently damaged. The external housing of the spirometer may be wiped with sterile wipes or a damp cloth that has been immersed in a cold sterilizing solution when required. -
Page 13: Cleaning The Transducer
following parts must be cleaned once a day: adapter (pediatric/adult) and the transducer. With any other use as described above all contaminated parts must be disinfected between patients. Important Note: Used single patient nose clips, mouthpieces and SpiroSafe filters must be disposed of immediately after the use. -
Page 14: Servicing
C u t - o u t L o c a t i n g p i p CAUTION: Do not attempt to wash or immerse the SpiroUSB transducer housing in water or cleaning fluid, as there are electronic components inside that will be permanently damaged. -
Page 15: Trouble Shooting Information
Trouble Shooting Information Should you encounter problems operating your SpiroUSB Spirometer, please consult the table below: Problem Possible Cause Solution Does not Head assembly Replacement of head register a blow or cable broken assembly or return the unit for servicing... -
Page 16: Safety Designation Per Iec 60601-1
Degree of Electrical connection Equipment between equipment and patient designed as non- electrical connection to the patient Degree of mobility Transportable Mode of operation Continuous Classifications according to IEC 60601-1 SpiroUSB Applied part, type B Volume Transducer Applied part, type B... -
Page 17: Electromagnetic Compatibility (Emc) To En60601-1:2007
WARNING: use of portable phones or other radio frequency (RF) emitting equipment near the system may cause unexpected or adverse operation. The SpiroUSB has been tested to EN60606-1-2:2007, regarding the ability to operate in an environment containing other electrical/electronic equipment... - Page 18 This cable should not be used with devices other than the SpiroUSB. If the cable is extended by the user using non-approved cables, this may result in an increased level of emissions or decreased level of immunity, in relation to the SpiroUSB’s EMC.
- Page 19 (USB powered) IEC61000-3-3 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The SpiroUSB is intended for use in the electromagnetic environment specified below. The customer or the user of the SpiroUSB should assure that it is used in such an environment.
- Page 20 25 cycles <5% U interruptions, it is (> 95% dip in U recommended that for 5 s the SpiroUSB be powered from an uninterruptible power supply or a battery Power frequency 3 A / m 3 A / m...
- Page 21 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The SpiroUSB is intended for use in the electromagnetic environment specified below. The customer or the user of the SpiroUSB should assure that it is used in such an environment. Immunity IEC 60601...
- Page 22 SpiroUSB The SpiroUSB is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the SpiroUSB can help prevent electromagnetic interference by maintaining a minimum distance...
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Page 23: Symbols
Symbols Type B device In accordance with Directive 93/42/EEC Disposal in compliance with WEEE Consult the instructions for use Manufacturer Date of Manufacture Serial Number Direct Current Single Patient Use Federal U.S. law restricts this device to sale by or Rx only on the order of a physician (Rx only) Batch Code... -
Page 24: Specification Of The Spirousb
Specification of the SpiroUSB Power supply: Input 5V 0.1A 2” x 2.4” x 3.5” Dimensions: Weight: 4.6 ounces Operating Temperature: 32 to 104 Operating Humidity: 30% to 90% RH Storage & Transport Pressure: 650 – 1060 hPa Storage Temperature: -4 to 158... - Page 25 Spirometry Measurements Relaxed Expiratory Vital Capacity (VC) Forced Expired Volume in 0.75 seconds (FEV.75) Forced Expired Volume in 1 second (FEV1) Forced Expired Volume in 3 second (FEV3) Forced Expired Volume in 6 seconds (FEV6) Forced Vital Capacity (FVC) Peak Expiratory Flow Rate (PEF) as a percentage of VC (FEV.75/VC) 0.75 a percentage of FVC (FEV.75/FVC)
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Page 26: Consumables / Supporting Products
Mouthpiece, Plastic, One-way (box of 200) PSA1100 Pediatric adapter (30mm - 22mm) 3301 Mouthpieces, Disposable Cardboard (bag of 100) 3304 Nose Clips (pack of 20) 48-70 Protex Disinfectant Wipes 3325 3 Liter Calibration Syringe ASS1041 SpiroUSB Desktop Stand CAB1047 USB Extension Cable TDX1043 Turbine Transducer... -
Page 27: Customer Contact Information
Please Note: Information in this manual is subject to change without notice and does not represent commitment on the part of Micro Direct, Inc. The software may be used or copied only in accordance with the terms of that agreement. No part of this... -
Page 28: Icd-10 Codes For Spirometry
ICD-10 Codes for Spirometry Diagnosis Code Acute Bronchitis J20.0-J20.9 Allergic Rhinitis, Other J30.81-J30.89 Allergic Rhinitis, Unspecified J30.9 Vasomotor and Allergic Rhinitis J30.0-J30.5 Asthma, Mild, Intermittent J45.20-J45.22 Asthma, Mild, Persistent J45.30-J45.32 Asthma, Moderate, Persistent J45.40-J45.42 Asthma, Severe, Persistent J45.50-J45.52 Asthma, Unspecified J45.901-J45.909 Cough Variant Asthma J45.991... - Page 29 Pneumonitis J67.0-J67.9 Pulmonary, Fibrosis J84.10 Respiratory conditions due to inhalation of chemicals, gases, J68.0-J68.9 fumes and vapors Respiratory conditions due to J70.9 unspecified external agent Sarcoidosis of the Lung D86.0 Sarcoidosis of the Lung with D86.2 sarcoidosis of the lymph nodes Bronchiolitis, Acute J21.0-J21.9 Bronchitis, Not Specified as...
- Page 30 Nicotine Dependence** F17.200-F17.299 Tobacco Use (NOS)** Z72.0 Occupational exposure to Z57.31 environmental tobacco smoke** Personal history of Z87.891 nicotine dependence** Smoking (tobacco) complicating pregnancy, O99.330-O99.335 childbirth, and the puerperium** Wheezing R06.2 **Use additional code after the primary diagnosis to identify any tobacco use, dependence or exposure to tobacco smoke Rev.
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