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Summary of Contents for Vitalograph VitaloQUB 9160
- Page 1 VitaloQUB ® MODEL 9160 Instructions for Use © Copyright Vitalograph 2024 Current Edition (Issue 2, 22-Jan-2024) Cat. No. 09650...
- Page 2 E-mail: contact@vitalograph.com Technical Support www.vitalograph.com Tel: +353 65 6864111 Technical Support Email: technical.support@vitalograph.ie Tel: (913) 730-3205 Email: technical.support@vitalograph.com © Copyright Vitalograph 2024 Vitalograph and VitaloQUB ® Current Edition (Issue 2, 22-Jan-2024) registered trademarks. Cat. No. 09650 Page 2 of 24...
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Page 3: Table Of Contents
Contraindications, Warnings, Precautions and Adverse Reactions ............4 2.1. Contraindications and Adverse Reactions ..................4 2.2. Warnings and Precautions ......................... 4 Main Components of the Vitalograph VitaloQUB ..................6 3.1. Features of the Vitalograph VitaloQUB ..................... 7 Setting Up the Vitalograph VitaloQUB ...................... 8 Operating Instructions .......................... -
Page 4: Indications For Use
1. Indications for Use The Model 9160 Whole-Body Plethysmograph device, when used with the Vitalograph Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research centres. - Page 5 Power Switch on the paired device and remove the Power Supply from the mains wall socket. 17. Do not position the device so that the Main Power Switch is inaccessible, or that the Power Supply is difficult to unplug from the socket. 18. Use of accessories and cables other than those specified or provided by Vitalograph for this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of the VitaloQUB and result in improper operation. Only equipment that has been specified in Section 10 as compatible for use with the system shall be used.
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Page 6: Main Components Of The Vitalograph Vitaloqub
A Global Leader in Respiratory Diagnostics 3. Main Components of the Vitalograph VitaloQUB The main components are: Figure 1- Main Components of the VitaloQUB Page 6 of 24 DT_0006 Issue 17... -
Page 7: Features Of The Vitalograph Vitaloqub
Auxiliary Connection - Ext Tube Connector Ports Power Supply Connection USB Comms Port 3.1. Features of the Vitalograph VitaloQUB The features include: • VTG & Airway Resistance testing • 12” White Internal Display Monitor for patient viewing • Dual-way intercom/speaker system for clinician & patient interaction •... -
Page 8: Setting Up The Vitalograph Vitaloqub
• Pairs with both VitaloROV/ROV+ and VitaloLAB devices • Interchangeable Patient Valve as used in the VitaloROV/ROV+ and VitaloLAB 4. Setting Up the Vitalograph VitaloQUB Note: This device can only be used in conjunction with the VitaloROV/ROV+ device or the VitaloLAB device and must be setup by approved Vitalograph technicians. - Page 9 VitaloQUB - Instructions for Use 09650 Issue 2 attachment on the Patient Valve Control Arm (24). Four M5 screws are used to secure the arm in place. Figure 3- Patient Valve Control Arm Holder 10. Attach the Monitor Bracket (1) from Accessories Box to the Patient Valve Control Arm (24) using the supplied attachment screw on the Patient Valve Control Arm (24).
- Page 10 A Global Leader in Respiratory Diagnostics Figure 6- Speaker/Mic mounted to Monitor Bracket 12. Connect the DC Power Cable to the back of the Monitor (20) and then connect the other end to item 26 (figure 1) on the underside of the Internal Enclosure (2). This cable is pre-assembled to the Patient Valve Control Arm (24). 13. Connect the HDMI Cable to the back of the Monitor (20) and then connect the other end to item 29 (figure 1) on the underside of the Internal Enclosure (2). This cable is pre-assembled to the Patient Valve Control Arm (24). 14.
- Page 11 VitaloQUB - Instructions for Use 09650 Issue 2 16. Plug in the Heater Connector cable beside the Bulkhead Connector to item 31 (figure 1), aligning the white line on the connector with corresponding white line on connector on the underside of the Internal Enclosure as in Figure 9. Figure 9: Alignment markings shown on Heater Connector 17. Fit the cable management clips between the Patient Valve Umbilical and the white spiral wrap that connects the wiring from the Control Arm to the underside of the Internal Enclosure.
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Page 12: Operating Instructions
Always ensure Heater Connector is connected at back of device. 5. Operating Instructions For guidance using the ComPAS2 software on the device, refer to ComPAS2 Reference Manual (Vitalograph Morgan PFT Range), available in the help menu in ComPAS2 software by choosing Help > View Help. - Page 13 VitaloQUB - Instructions for Use 09650 Issue 2 Figure 11: Patient Valve Control Arm Vertical Positioning Mechanism 6. The arm can be adjusted or pivoted by rotating the arm to the required position. Figure 12: Hinge Points on Patient Valve Control Arm 7. Once the subject has been positioned correctly advise the subject that they can view the Display Monitor (20) which is located beside the Patient Valve.
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Page 14: Sensor Calibration
5.1. Sensor Calibration Calibration of all pressure, flow and gas sensors is done using ComPAS2 software. For guidance, refer to the ComPAS2 Reference Manual (Vitalograph Morgan PFT Range) in the ComPAS2 software help menu by choosing Help > View Help. 5.2. Cybersecurity Considerations 5.2.1. Specification The VitaloQUB has no operating system and as such will not be accessible unless it is connected to its paired device VitaoLAB or VitaloROV/ROV+. For further information in relation to cybersecurity specifications... -
Page 15: Power Supply Information
6 pin Molex Type 7. Cleaning & Hygiene 7.1. Preventing Cross-Contamination of Subjects The VitaloQUB 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 16: Customer Service
Any serious incident that has occurred in relation to the device should be reported to Vitalograph or its Authorized Representative and the Regulatory Authorities of the country. Refer to the Vitalograph contact information at the start of this manual. This IFU is available on the Vitalograph website at the following location: www.vitalograph.com/ifu/Vitalograph_VitaloQUB_IFU.pdf... -
Page 17: Disposal
Accessories: 1. The 3 litre Precision Syringe should be returned to Vitalograph for disposal at the product end-of-life. 2. Electrical accessories must be disposed of separately according to the regulations for your country. 3. Used BVFs constitute minimally soiled waste from human healthcare and should be disposed of in line with local requirements. BVFs are made from polypropylene. - Page 18 A Global Leader in Respiratory Diagnostics The device must be taken to separate collection at the product end-of-life. Do not dispose of these products as unsorted municipal waste Fragile, handle with care Keep Dry Do not re-use Non-sterile Recycle QR code - matrix bar code. All information in the bar code is included in the text under it Use by date Batch code Refer to instruction manual/booklet...
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Page 19: Description Of The Vitalograph Vitaloqub
This Instructions for Use relates to the hardware of the VitaloQUB 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: Technical Specification
Vitalograph will make available any information necessary to assist Service Agents to repair parts, such as •... -
Page 21: Ce Notice
The Vitalograph - VitaloQUB is intended for use in primary care, hospitals, and pharmaceutical research 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 – VitaloQUB should assure that it is used in such an environment. -
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: Guarantee
09650 Issue 2 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.
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