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Related Manuals for Micro Direct PulmoLife
Summary of Contents for Micro Direct PulmoLife
- Page 1 PulmoLife 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 064-45 US Issue 1.9 February 2016...
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Page 2: Table Of Contents
Table of Contents Introduction ........................2 Contraindications ........................ 2 Warnings and Cautions ...................... 2 Intended Use ........................4 Entering Patient Details ...................... 4 Performing a Test ....................... 5 Cleaning ..........................7 Calibration Check ......................10 Service ..........................10 Battery ..........................11 Product Lifetime ....................... -
Page 4: Introduction
Introduction The PulmoLife unit measures the Forced Expiratory Volume in the First Second of Expiration (FEV1) and the FEV1 as a Percentage of the Predicted Value (FEV1% predicted). The use of FEV1 is a useful diagnostic tool for early detection of COPD . - Page 5 WARNING: Conditions or practices that could result in personal injury PLEASE NOTE: Important information for avoiding damage to the instrument or facilitating operation of the instrument. CAUTION: Read the manual before use CAUTION: For batteries, do not attempt to charge, connect improperly, or dispose of in fire as there is possibility of leakage disposal.
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Page 6: Intended Use
Intended Use The intended use of PulmoLife is to quickly and easily screens smokers for early detection of Chronic Obstructive Pulmonary Disease (COPD). The effects of COPD in smokers are normally detectable from the age of 35. The measurement taken from the unit can help in the diagnosis, management and treatment during the early stages of COPD development. -
Page 7: Performing A Test
The display will show the blow symbol and 0.00. Performing a Test See further instructions on flap in the PulmoLife box. Insert a new disposable one-way valve mouthpiece into the turbine holder. With the display showing the blow symbol and 0.00. - Page 8 The FEV1 and FEV1% predicted will be displayed. If a blow is too slow at the beginning of the manuveur , the blow icon will flash assessing this test as poor quality and the test should be repeated. After a full inspiration, the patient should be encouraged to blast out the air as fast as possible without hesitation.
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Page 9: Cleaning
Use the scrolling Up / Down keys to move back and forth between both results screens. Press Enter to perform a new blow. It is recommended that a spirometry result should be taken from the best of 3 technically correct blows. To test another patient the unit must be switched off and on and then enter the new patient details. - Page 10 CAUTION: Switch off the device before cleaning. The external housing of the PulmoLife may be wiped may be wiped with a disinfection wipe such as a Protex wipe (order #48-70). This should be performed after every patient.
- Page 11 CAUTION: Do not attempt to wash or immerse the PulmoLife in water or cleaning fluid, as there are electronic components inside that will be permanently damaged.
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Page 12: Calibration Check
Calibration Check To check the calibration, hold down the On and Scrolling Up keys together, and When the blow symbol -litre syringe smoothly into the unit. The value will be displayed. If the unit detects an error the blow symbol and calibration value will flash. -
Page 13: Battery
Battery The PulmoLife is powered by a 3 Volt Lithium coin cell accessed via a slide cover on the switched on with a low battery level, the unit will beep three times and then turn off after 5 seconds. The battery is contained beneath the slide cover in the rear of the unit. For access... -
Page 14: Product Lifetime
PLEASE NOTE: Dispose of the waste battery in accordance with your local recycling facility. Product Lifetime The PulmoLife is designed for a product lifetime of 5 years. Predicted Value Set Up To change the Predicted Value Settings, from the default shown on the box, hold down the... -
Page 15: Version
When the desired number is selected press the Enter key to accept and save that predicted value set as default. Version To check the version number, hold down the On and Scrolling Down keys Troubleshooting Information Should you encounter problems operating your PulmoLife unit, please consult the table below:... - Page 16 Problem Possible Cause Solution Does not register a Turbine Ensure turbine is tightly pushed into the blow incorrectly fitted unit. Unit does not turn Battery is Replace battery exhausted indicator is displayed, while unit beeps three times and powers itself down after 5 seconds Calibration Check There are leaks...
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Page 17: Safety Designation Per Iec 60601-1
Safety Designation Per IEC 60601-1 Type of protection against electrical Internally powered Equipment shock Degree of protection against Type B applied part electrical shock Power Equipment Battery type: 3V Lithium Ion Coin Cell Battery (model no CR-2450) Degree of Electrical connection Equipment designed as non-electrical connection between equipment and Patient to the patient. -
Page 18: Electromagnetic Compatibility (Emc)
(including other medical devices). The purpose of this testing is to ensure that the PulmoLife is not likely to adversely affect the normal operation of other such equipment and that other such equipment is not likely to adversely affect the normal operation of the PulmoLife. - Page 19 PulmoLife must not begin to measure unintentionally during a test and should pass a posttest 3-liter calibration syringe measurement). Electromagnetic Immunity The PulmoLife is intended for use in the electromagnetic environment specified below. The customer or the user of the PulmoLife should assure that it is used in such an environment. Emission Test...
- Page 20 IEC61000-3-3 Electromagnetic Immunity The PulmoLife is intended for use in the electromagnetic environment specified below. The customer or the user of the PulmoLife should assure that it is used in such an environment. Immunity Test IEC 60601 test...
- Page 21 Electromagnetic Immunity The PulmoLife is intended for use in the electromagnetic environment specified below. The customer or the user of the PulmoLife should assure that it is used in such an environment. Immunity Test IEC 60601 test Compliance Level Electromagnetic Environment -Guidance...
- Page 22 Electromagnetic Immunity The PulmoLife is intended for use in the electromagnetic environment specified below. The customer or the user of the PulmoLife should assure that it is used in such an environment. Immunity Test IEC 60601 test Compliance Level Electromagnetic Environment -Guidance...
- Page 23 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the PulmoLife is used exceeds the applicable RF compliance level above, the PulmoLife should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orientating or relocating the PulmoLife b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
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Page 24: Specifications
Specifications Measurement Forced Expiratory Volume in 1 second (FEV1) Forced Expiratory volume in 1 second as a percentage of predicted (%FEV1) Lung Age Transducer: Digital Volume Transducer Resolution: 0.01L Accuracy: +/-3% To ATS/ERS Taskforce Standardization of Spirometry, 2005 Volume Range: 0 - 8 L As per ATS/ERS Recommendations Flow Range: 0-14 L/s as per ATS/ERS Recommendations... -
Page 25: Accessories
Accessories Product Order Number MicroCheck one-way valve mouthpieces (Box of 200) 3395 Adult Disposable Mouthpieces (200 per box) 3314S B Adult Disposable Mouthpieces (500 per box) 3314B5 Pouch CAS1048 Replacement Turbine TDX1050 3 Liter Calibration Syringe 3325 Protex Disinfectant Wipe (100/canister) 48-70... -
Page 26: Symbols
Symbols Type B device In accordance with Directive 93/42/EEC Disposal in compliance with WEEE Consult the instructions for use Date of Manufacture Manufacturer Serial number Direct current Single patient use Federal U.S. law restricts this device to sale by or on the order of a Rx only physician. -
Page 27: References
Website: www.mdspiro.com Or contact your local Micro Direct distributor. References 1. Nice COPD Guidelines 2004, Thorax 2004: 59 (suppl1): 1-232 Preventative Medicine, 1995; 14 655-662 3. ATS/ERS Task Force Standardization of Spirometry2005 Update, Eur Respir J 2005; 26: 319-338 4.
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