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Summary of Contents for Vitalograph Compact
- Page 1 Compact MODEL 6600 Rx Only Instructions for Use © Copyright Vitalograph 2023 Current Edition (Issue 2, 09-Feb-2023) Cat. No. 09220...
- Page 2 Tel: +49 40 547391-0 Fax: +49 40 547391-40 E-mail: info@vitalograph.de www.vitalograph.com Technical Support Telefon: +49 40 547391-14 E-mail: technical.support@vitalograph.de © Copyright Vitalograph 2023 Current Edition (Issue 2, 09-Feb-2023) Cat. No. 09220 Vitalograph is a registered trademark. DT_0006 Issue 17 Page...
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Page 3: Table Of Contents
09220 Issue 2 Contents Indications for Use ................4 Contraindications, Warnings, Precautions and Adverse Reactions ..............4 Main Components of the Vitalograph Compact ......7 3.1. Features of the Vitalograph Compact ........8 Setting Up the Vitalograph Compact ..........8 4.1. Compact Communications ............9 Operating Instructions ...............9 Power Management .................10... -
Page 4: Indications For Use
2. Any changes to the operating system or additional unapproved installations must be validated by the end user. 3. The Compact is not designed as a sterile device. Always follow the safety guidelines given by the manufacturer of cleaning and disinfectant chemicals. - Page 5 Subject may also take a break between tests. When the Compact device is used a subject fatigue warning will appear after 8 manoeuvres.
- Page 6 25. The device may be susceptible when exposed to high levels of electrostatic discharge. To restore function, press the On/Off switch. 26. To isolate the Model 6600 Compact from the mains supply, remove the 19V Power Supply from the mains wall socket. Do not position the 19V Power Supply where it is difficult to unplug from the socket. ...
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Page 7: Main Components Of The Vitalograph Compact
Vitalograph COMPACT - Instructions for Use 09220 Issue 2 3. Main Components of the Vitalograph Compact Figure 1. Main components of the COMPACT Power Supply Stylus I/O Ports - 6 x USB, 2 x Ethernet, 2 x Display Port Power connection, RMS port (MIP/MEP/SNIP) and flowhead port... -
Page 8: Features Of The Vitalograph Compact
6. Connect the jack plug from the power supply into the socket at rear of the Compact. Plug the mains plug into a suitable socket, operate the On/Off button on the side of the instrument. The Compact is ready for use. Note: Only use the Compact with the purpose-built low voltage power supply with which it is supplied. -
Page 9: Compact Communications
PC/Network and NOT on the Compact device. 10. To power down Compact close the Spirotrac session by pressing the power button on the menu at the left side, this will automatically log-off the current user and return to the Launcher. In the Launcher the power option is in the menu on the left. -
Page 10: Power Management
Network and NOT on the Compact device. 6. Power Management The Vitalograph Compact must be powered using the 19V low voltage Power Supply unit supplied with the device. The Power Supply unit should be checked regularly and replaced when necessary. - Page 11 Vitalograph COMPACT - Instructions for Use 09220 Issue 2 Flowhead Complete Flowhead End Cap Flow Conditioning Mesh Fleisch element Assembly ‘O’ Rings Pressure Tapping Flowhead Cone Figure 3: Fleisch Flowhead Assembly MIP/MEP Flowhead: Visual inspection is recommended on a routine basis. Unscrew the MIP/MEP end cap from the cone.
- Page 12 Screw the MIP/MEP end cap to the cone. Ensure it is fully screwed home and hand tightened. Attach the white end of the flowhead connection tube to the pressure tapping on the MIP/MEP flowhead. The clear end of the flowhead connection tube is connected to the push in connector adjacent to the spirometry connector on the Compact base. To check the MIP/MEP flowhead has been correctly re-assembled attach a BVF to the MIP/MEP Flowhead and test as follows: 1. MEP Flowhead: fully inspire though the flowhead. The one-way valve should open, and no resistance should be felt.
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Page 13: Fault Finding Guide
Vitalograph COMPACT - Instructions for Use 09220 Issue 2 8. Fault Finding Guide Problem Fault Symptoms: • Incorrect or no volume measurements • Ensure tubing is connected correctly. Possible Causes: • Ensure that connectors are clear of (In probable order) obstruction or dirt and are inserted fully. -
Page 14: Software Check
Information about Spirotrac, and the IFU, is available in the ‘’i’ (information) option in the menu on the left side of the Spirotrac application. This information may be used when contacting Vitalograph or a service agent with queries. DT_0006 Issue 17... -
Page 15: Product Useful Life Checks
Service and repairs should be carried out only by the manufacturer, or by Service Agents approved by Vitalograph. Contact information for approved Vitalograph Service Agents may be found at the start of this manual. Any serious incident that has occurred in relation to the device should be reported to Vitalograph or its Authorised Representative and the Regulatory Authorities of the country. -
Page 16: Disposal
Silicone One-way Valve (Pack of 2) 77973 SNIP Nasal Probe Adaptor 67242 Compact Stylus 11. 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 BVFs constitute minimally soiled waste from human healthcare and should be disposed of in line with local requirements. -
Page 17: Description Of The Vitalograph Compact
Test data is automatically stored to the relevant subject record. The software running on the Compact allows it to be used as a standalone lung function testing device. In a clinical setting, the measurements obtained from a lung function test form part of the various findings of a physician in the detection, diagnosis and control of chest diseases. -
Page 18: Technical Specification
Operating humidity range 30%–75% Operating ambient pressure 850hPa–1060hPa range Performance standards ISO 23747:2015, ISO 26782 2009, ATS/ERS 2019 the Vitalograph COMPACT meets or exceeds Safety standard EN60601-1:2006 + A1:2013 + A2:2021 + A2:2021 EMC standard EN 60601-1-2:2015 + A1:2021 QA/GMP standards EN ISO 13485:2016, FDA 21 CFR 820, CMDR SOR/98-282 &... -
Page 19: Ce Notice
Marking by the symbol indicates compliance of the Vitalograph Model 6600 Compact to the Medical Devices Directive of the European Community. The Vitalograph Compact is intended for use by trained healthcare professionals in a variety of professional healthcare environments, e.g. primary... - Page 20 Group 1 emissions are very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment. The Model 6600 Compact is suitable for use in professional environments only, such as RF emissions hospitals, clinics. Class A...
- Page 21 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.
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Page 22: Fda Notice
A Global Leader in Respiratory Solutions Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided (refer to section 2. Contraindications, Warnings, Precautions and Adverse Reactions). Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). -
Page 23: Eu Declaration Of Conformity
09220 Issue 2 17. EU Declaration of Conformity Product: 6600 Vitalograph Compact 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: •... -
Page 24: Guarantee
A Global Leader in Respiratory Solutions 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 Vitalograph COMPACT - Instructions for Use 09220 Issue 2 Page of 28...
- Page 26 A Global Leader in Respiratory Solutions DT_0006 Issue 17 Page of 28...
- Page 27 Vitalograph COMPACT - Instructions for Use 09220 Issue 2 Page of 28...
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