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Summary of Contents for Micro Direct MD Spiro Pneumotrac
- Page 1 Pneumotrac Model MD6800 Instruction for Use Current Edition (Issue 2, 27-Jul-2020) Cat. No. 09000 Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240 Toll Free: 800-588-3381 Email: support@mdspiro.com...
- 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
Table of Contents 1. Main Components of the Pneumotrac ......1 1.1 Features of the Pneumotrac ........1 2. Setting Up the Pneumotrac ..........2 3. Operating Instructions ............ 3 4. Power Management ............3 5. Cleaning & Hygiene ............3 5.1 Preventing Cross-Contamination of Subjects ... -
Page 4: Main Components Of The Pneumotrac
1. Main Components of the Pneumotrac Figure 1 Main components of Pneumotrac USB Flash Drive Containing Spirotrac. Reference Spirotrac Instructions For Use for Details USB Cable Pneumotrac Base Flowhead Connection Tubing Flowhead SpiroSafe Viral/Bacterial Filter Note: Computer not supplied 1.1 Features of the Pneumotrac •... -
Page 5: Setting Up The Pneumotrac
2. Setting Up the Pneumotrac Figure 2 1. Remove USB drive from packaging. 2. Insert USB drive into USB port on computer. 3. Browse USB drive and click Setup. 4. Select Install Spirotrac. Follow on-screen instructions to complete installation. Further details are provided in the Spirotrac Instructions for Use supplied with the software. -
Page 6: Operating Instructions
5. Cleaning & Hygiene 5.1 Preventing Cross-Contamination of Subjects A spirometer is not designed or supplied as a ‘sterile’ device. Micro Direct intends that a new SpiroSafe, viral/bacterial, filter be used for every subject to prevent cross contamination. Using a new SpiroSafe provides a significant level of protection of the subject, the device and the user against cross contamination during spirometry maneuvers. -
Page 7: Inspection Of The Pneumotrac
5.2 Inspection of the Pneumotrac Visual inspection is recommended on a routine basis. Remove the flowhead cone and flowhead end cap from the flowhead (figure 3). Examine flow conditioning mesh filters for damage or contamination. If they are damaged or blocked, discard and replace with new parts. Examine the O-rings on the Fleisch element and replace if damaged. -
Page 8: Fault Finding Guide
6. Fault Finding Guide • Problem Fault Accuracy check variations > ± 2.5% • Symptoms False readings suspected • Recheck accuracy (Section Operating Instructions). • Was the correct syringe volume selected? • Flowhead conditioning mesh missing or blocked. • Flow head pressure tapping holes blocked. Possible •... -
Page 9: Customer Service
3-Liter Calibration Syringe 77933 Flow Conditioning Mesh 79192 Flowhead Connection Tube 48-70 Protex Disinfectant Wipe To place an order for consumables and accessories, for service/repair or for general questions please contact Micro Direct at: Toll Free: 1-800-588-3381 Telephone: 207-786-7808 Fax: 207-786-7280 Email: sales@mdspiro.com... -
Page 10: Disposal
9. Disposal The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste. Used SpiroSafe filters constitute minimally soiled waste from human healthcare and should be disposed of in line with local requirements. SpiroSafe filters are made from impact polystyrene. -
Page 11: Device Description And Indications For Use
Keep Dry Do not-reuse Non sterile Recycle QR code - matrix bar code. All information in the bar code is included in the text under it 11. Device Description and Indications for Use The Pneumotrac is a spirometer which measures subject respiratory parameters including but not limited to VC, FVC, FEV , PEF and MVV. -
Page 12: Technical Specification
12. Technical Specification Product Pneumotrac Spirometer Model MD6800 Flow Detection Principal Fleisch type pneumotachograph Volume Detection Flow integration sampling @ 100 Hz Volume Accuracy Within ± 2.5% Flow Measurement Max flow rate ± 960 L/min (± 16 L/s) Range Min. flow rate ±1.2 L/min (± 0.02 L/s) PEF Accuracy Within ±... -
Page 13: Contraindications, Warnings, Precautions And Adverse Reactions
13. Contraindications, Warnings, Precautions and Adverse Reactions 1. No modification of this equipment is allowed. Any unauthorized changes to the Pneumotrac device may compromise product safety and/or data and as such the manufacturer cannot be held responsible and the device will no longer be supported. 2. -
Page 14: Ce Notice
14. Maintenance must not be performed while the device is in use by a subject. 15. Use of accessories or cables other than those specified or provided by the manufacturer for this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of the Pneumotrac and result in improper operation. -
Page 15: Fda Notice
EN 60601-1-2:2015 Emissions tests Electromagnetic environment – guidance Emissions Compliance test The Model 6800 Pneumotrac uses RF energy only for its internal function. emissions Group 1 Therefore, its RF emissions are very low CISPR 11 and are not likely to cause any interference in nearby electronic equipment. -
Page 16: Eu Declaration Of Conformity
16. EU Declaration of Conformity Product: 6800 Pneumotrac The manufacturer hereby ensures and declares the above product associated with these instructions for use, is designed and manufactured in accordance with the following QMS regulations and standards. • European Medical Devices Directive {MDD} 93/42/EEC, as amended. - Page 17 The Company warrants the software when correctly used in conjunction with the hardware will perform in the manner described in the Company’s literature and user manuals. The Company undertakes to rectify at no expense to the customer any software failure notified with the period stated above, provided the failure can be recreated and the software has been installed and used in accordance with the user manual.
- Page 18 CD-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 19 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 20 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 Please Note: Information in this manual is subject to change without notice and does not represent commitment on the part of the manufacture.
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