Related Manuals for Vitalograph VitaloLAB 9100
Summary of Contents for Vitalograph VitaloLAB 9100
- Page 1 VitaloLAB ® MODEL 9100 Rx Only Instructions for Use © Copyright Vitalograph 2024 Current Edition (Issue 4, 06-Nov-2024) Cat. No. 09970...
- Page 2 E-mail: contact@vitalograph.com www.vitalograph.com www.vitalograph.com Technical Support Technical Support Tel: +353 65 6864111 Tel: (913) 730-3205 Email: technical.support@vitalograph.ie Email: technical.support@vitalograph.com © Copyright Vitalograph 2024 Vitalograph and VitaloLAB ® Current Edition (Issue 4, 06-Nov-2024) registered trademarks. Cat. No. 09970 Page 2 of 28...
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Page 3: Table Of Contents
VitaloLAB - Instructions for Use 09970 Issue 4 Contents 1. Indications for Use ............................4 2. Contraindications, Warnings, Precautions and Adverse Reactions ............4 2.1. Contraindications and Adverse Reactions ..................4 2.2. Warnings and Precautions ........................4 3. Main Components of the VitaloLAB ......................6 3.1. -
Page 4: Indications For Use
2.2. Warnings and Precautions 1. No modification of this equipment is allowed. Any unauthorised changes to the VitaloLAB device may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported. 2. The VitaloLAB is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals. - Page 5 If the device or Patient Valve have been dropped it is recommended that a Single Breath Diffusion Quality Control Test is performed to check functionality. For details on the test, see the ComPAS2 Reference Manual (Vitalograph Morgan PFT Range), available in the ComPAS2 software help menu by choosing Help > View Help.
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Page 6: Main Components Of The Vitalolab
It is recommended that a Single Breath Diffusion Quality Control Test is performed to check functionality. For details on the test, see the ComPAS2 Reference Manual (Vitalograph Morgan PFT Range), available in the ComPAS2 software help menu by choosing Help > View Help. -
Page 7: Features Of The Vitalolab
VitaloLAB - Instructions for Use 09970 Issue 4 3.1. Features of the VitaloLAB The VitaloLAB features include: • Lilly screen pneumotachograph to measure flow • External weather station • ComPAS2 software • Choice of child incentive displays • Customisable report format • Pre/post bronchodilator comparison •... - Page 8 A Global Leader in Respiratory Diagnostics 3. Only use VitaloLAB with the supplied medically approved low voltage power supply. Attempted use with other power sources may cause irreparable damage and invalidate the warranty. 4. Connect power supply (B) into socket on back of the VitaloLAB device. Plug mains plug into a suitable socket. Turn on the Main Power Switch (C) on back of device.
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Page 9: Operating Instructions
VitaloLAB - Instructions for Use 09970 Issue 4 5. Operating Instructions For guidance on using the ComPAS2 software on the device, refer to ComPAS2 Reference Manual (Vitalograph Morgan PFT Range), available in the software help menu by choosing Help > View Help. 1. On first use: a. -
Page 10: Power Supply Information
6 pin Molex Type 7. Cleaning & Hygiene 7.1. Preventing Cross-Contamination of Subjects Pulmonary function test equipment is not designed or supplied as a ‘sterile’ device. Vitalograph intends that a new Bacterial Viral Filter (BVF ) be used for every subject to prevent cross contamination. Using a new BVF provides a significant level of protection of the subject, the device and the user against cross contamination during pulmonary function test manoeuvres. - Page 11 VitaloLAB - Instructions for Use 09970 Issue 4 7.2.1. Accessing the Lilly Screen Figure 5: Exploded Assembly for Patient Valve with Inspiratory Bag Front Cap Inspiratory Bag Housing Adaptor Shutter Seal Plate Flowhead Subject End Inspiratory Bag Cap Breathing Tube Lilly Screen Inspiratory Bag Housing Top One-Way Valve Assembly...
- Page 12 A Global Leader in Respiratory Diagnostics 1. Remove Inspiratory Bag from Patient Valve Figure 6- Front Cap in the unlock location. 2. Turn Front Cap anticlockwise to the unlock position (Figure 6) and remove (Figure 7). Figure 7 - Flowhead with Front Cap removed. 3.
- Page 13 VitaloLAB - Instructions for Use 09970 Issue 4 4. Turn the flowhead subject end anticlockwise to the unlock position and remove, giving access to the Lilly Screen (Figure 9). Figure 9 - Flowhead subject end in the unlock position. 5. Remove the Lilly Screen and clean it. 6. Fit Flowhead Subject End to Heater Assembly by lining up large and small alignment keys as in Figure 10 and then turning the parts clockwise to the lock position.
- Page 14 A Global Leader in Respiratory Diagnostics 8. Align the arrow on the front cap with the unlock position on the flowhead body (Figure 12). Carefully push in the front cap fully and turn clockwise until in the locked position. Figure 12 - Front cap aligned in the unlock position. Figure13 - Front cap in the unlock position. 9. On the Patient Valve, push round collar of Inspiratory Bag into opening on Inspiratory Bag Housing. 10.
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Page 15: Fault Finding Guide
• Report does not print some parameters • Ensure correct report settings are entered in Reports page in ComPAS2 software. See Possible Causes: Reports section of Morgan Scientific ComPAS2 Reference Manual (Vitalograph Morgan PFT (In probable order) Range), available in the help menu in ComPAS2 software by choosing Help > View Help. -
Page 16: Customer Service
Service life of the VitaloLAB is 1 year. Service and repairs should be carried out only by the manufacturer or by Service Agents approved by Vitalograph. Preventative inspection and maintenance should be performed annually by Service Agents only on the following parts: the Manifold Filters, Sample Line Filters, Fuses and Nafion Tubing. The Oxygen Leak Sensor is due to be changed every... -
Page 17: Explanation Of Symbols
VitaloLAB - Instructions for Use 09970 Issue 4 12. Explanation of Symbols Symbol Description Type BF applied part Class II On (power) Off (power) Power rating (power supply) Direct current (power supply) UL Component Recognition Mark for Canada and U.S.A. (power supply) CE mark (power supply) Rx Only Restricted to sale by, or on the order of a physician. - Page 18 A Global Leader in Respiratory Diagnostics Serial interface Refer to instruction manual/booklet Computer network Serial port Transfer of heat in general SNIP Sniff nasal inspiratory pressure DLCO gas connection O2 gas connection (VitaloROV+ Only) Calibration gas connection (VitaloROV+ Only) Serial number Catalogue number MIP/MEP Maximum inspiratory pressure/Maximum expiratory pressure Lock location mark...
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Page 19: Description Of The Vitalolab
This Instructions for Use document relates to the hardware of the VitaloLAB only. For guidance on using ComPAS2 software refer to the ComPAS2 Reference Manual (Vitalograph Morgan PFT Range), available in the help menu in ComPAS2 software by choosing Help > View Help. - Page 20 • The Patient Valve is a type BF applied part. The device body or other accessories are not applied parts. An applied part is a part of the equipment that in normal use necessarily comes into physical contact with the subject for the equipment or system to perform its function. • Vitalograph will make available any information necessary to assist Service Agents to repair parts, such as circuit diagrams, part lists, descriptions, calibration instructions or other information. Page...
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Page 21: Ce Notice
The Vitalograph VitaloLAB is intended for use in a variety of professional healthcare and home environments, e.g. private domiciles, primary care, hospital wards, occupational health centres, except for near active high frequency surgical equipment and the RF shielded room of an ME system for magnetic resonance imaging, where the intensity of electromagnetic disturbance is high. The customer or the user of the Vitalograph VitaloLAB should assure that it is used in such an environment. The 9100 Vitalograph VitaloLAB has been tested in accordance with: EN 60601-1:2006+A1:2013+A2:2021 with US deviations - Medical electrical equipment –... -
Page 22: Fda Notice
(50 kHz PM) (50 kHz PM) Medical Devices may be affected by mobile RF communications equipment including cellular telephones and other personal or household devices not intended for medical facilities. It is recommended that all equipment used near the Vitalograph product comply with the medical electromagnetic compatibility standard and to check before use that no interference is evident or possible. If interference is suspected or possible, switching off the offending device is the normal solution, as is required in aircraft and medical facilities. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided. -
Page 23: Eu Declaration Of Conformity
17. EU Declaration of Conformity Product: 9100 Vitalograph - VitaloLAB Vitalograph hereby ensures and declares that the above product associated with these instructions for use, is designed and manufactured in accordance with the following QMS regulations and standards: • European Medical Device Regulation (MDR) 2017/745, as amended. -
Page 24: Guarantee
18. Guarantee Subject to the conditions listed below, Vitalograph Ltd. and its associated companies, (hereinafter called the Company) guarantee to repair or at its option replace any component thereof, which, in the opinion of the Company is faulty or below standard as a result of inferior workmanship or materials. - Page 25 VitaloLAB - Instructions for Use 09970 Issue 4 Page 25 of 28...
- Page 26 A Global Leader in Respiratory Diagnostics Page 26 of 28 TMP-10002-19...
- Page 27 VitaloLAB - Instructions for Use 09970 Issue 4 Page 27 of 28...
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