Vitalograph VitaloJAK 7100 Instructions For Use Manual
  1. Manuals
  2. Brands
  3. Vitalograph Manuals
  4. Medical Equipment
  5. VitaloJAK 7100
  6. Instructions for use manual

Vitalograph VitaloJAK 7100 Instructions For Use Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

VitaloJAK
MODEL 7100
Instructions for Use
© Copyright Vitalograph 2020 Current Edition (Issue 1, 24-Feb-2020) Cat. No. 09260

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the VitaloJAK 7100 and is the answer not in the manual?

Questions and answers

Related Manuals for Vitalograph VitaloJAK 7100

Summary of Contents for Vitalograph VitaloJAK 7100

  • Page 1 VitaloJAK MODEL 7100 Instructions for Use © Copyright Vitalograph 2020 Current Edition (Issue 1, 24-Feb-2020) Cat. No. 09260...
  • Page 2 Tel: +353 65 6864111 Technical Support Email: technical.support@vitalograph.ie Tel: +353 65 6864111 Email: technical.support@vitalograph.ie Vitalograph GmbH Rellinger Straße 64a Vitalograph Ltd, Hong Kong/China D-20257 Hamburg P.O. Box 812 Germany Shatin Central Post Office Tel: +49 40 547391-40 Hong Kong Fax: +49 40 547391-40 E-mail: sales@vitalograph.cn...

  • Page 3: Table Of Contents

    Vitalograph VitaloJAK - Instructions for Use 09260 Issue 1 Contents Main Components ..............4 1.1. Features ..............5 Set Up ...................5 2.1. Connecting the VitaloJAK to a PC .......6 2.2. Fitting a New Battery Pack ........7 2.3. Connecting the Air Microphone and Chest sensor ............8...

  • Page 4: Main Components

    A Global Leader in Respiratory Solutions 1. Main Components Figure 1 Main components of the VitaloJAK Page of 36 DT_0006 Issue 15...

  • Page 5: Features

    Wearable pouch for portability • Battery operated • Power on/off requires a key 2. Set Up The Vitalograph VitaloJAK is designed to be used with the Vitalograph Webportal accessed via a PC, for setup and recording retrieval.   Page of 36...

  • Page 6: Connecting The Vitalojak To A Pc

    A Global Leader in Respiratory Solutions To get the VitaloJAK ready for use: • Check that the contents of the packaging correlate with the site and test kit contents specified in the site manual. • Check the serial numbers of the VitaloJAK, Site Kit and Test Kits against the packing list in your shipment.

  • Page 7: Fitting A New Battery Pack

    Note: In the unlikely event that there is any visible damage to the battery pack, please contact Vitalograph 24/7 Support immediately. Do not use damaged battery packs 4. Fit the battery pack inside the battery compartment.

  • Page 8: Connecting The Air Microphone And Chest Sensor

    A Global Leader in Respiratory Solutions Figure 3: Fitting the Battery Pack 2.3. Connecting the Air Microphone and Chest sensor 1. Ensure the device is not attached to the subject and is powered down. 2. Feed a new chest sensor and air microphone cable into the pouch via the cable feed at the top.

  • Page 9: Setup Menu

    Vitalograph VitaloJAK - Instructions for Use 09260 Issue 1 Figure 5: Reattaching the Back Cover 2.4. Setup Menu The keypad on the front of the device is used to navigate through the device menus. The arrow symbols indicate the function of each...

  • Page 10: Operating Instructions

    A Global Leader in Respiratory Solutions 1. Turn the device on using the key. The red dot on the keyswitch should line up with the ‘I’ mark on the case when the device is powered on. 2. When the Main Menu is displayed select ‘Setup’. 3.

  • Page 11: Starting And Stopping A Recording

    Vitalograph VitaloJAK - Instructions for Use 09260 Issue 1 Note: A new sensor should not be applied if damage or irritation to the skin is evident. Slight redness can be expected as with the removal of any plaster or adhesive dressing.
  • Page 12 A Global Leader in Respiratory Solutions 3. When the Main Menu is displayed, select ‘Start Recording’. Figure 9: Main Menu 4. The Subject ID screen is displayed. Confirm subject and visit details. Note: If any of the subject or session details are incorrect, refer to the site manual for guidance.

  • Page 13: Subject Instructions

    Vitalograph VitaloJAK - Instructions for Use 09260 Issue 1 6. The Recording Duration Screen is displayed. Confirm the recording duration to begin the recording. Figure 12: Recording Duration Screen 7. The ‘Recording’ screen is displayed briefly per Figure 13, before going blank.

  • Page 14: Finishing A Cough Recording

    A Global Leader in Respiratory Solutions specific and are detailed in the Site Manual per study. The following are design features/requirements of the VitaloJAK: 1. The subject may press event buttons to register events during the recording session, or to mute the device, as instructed by the technician.

  • Page 15: Uploading Data

    Vitalograph VitaloJAK - Instructions for Use 09260 Issue 1 5. Remove the VitaloJAK from the pouch and turn off the device by turning the key so that the red dot on the keyswitch lines up with the ‘O’ mark on the case.

  • Page 16: Cleaning & Hygiene

    A Global Leader in Respiratory Solutions Note: The used chest sensor and battery pack should be retained until the recording has been analysed. See instructions in Section 5, Disposal. 4. Cleaning & Hygiene The VitaloJAK is not designated as a sterile device. A new chest sensor/air microphone assembly must be used for each subject/test.

  • Page 17: Power Management

    Vitalograph VitaloJAK - Instructions for Use 09260 Issue 1 for disposal of batteries. Return shipment instructions are included in the study site manual. Note: Do not dispose of these products as unsorted municipal or general waste. 6. Power Management The VitaloJAK is powered by a battery pack, comprising 3 x AA batteries, which should be replaced prior to configuring the device for each recording session.
  • Page 18 A Global Leader in Respiratory Solutions • Memory error symbol displays and LED flashes RED. Problem Fault Symptoms: Possible • Data has not written to memory. Shutdown Solutions: (In the device and contact support. probable order) • Battery Low Error symbol displays and the Problem Fault LED flashes RED.
  • Page 19 • If recording, the recording stops with this warning and an error is logged to the audit trail. Subjects should contact their Site Administrator. Site Administrator should turn off the device and contact Vitalograph support. • Internal Memory Full Error displays and the LED flashes RED.
  • Page 20 • Device is connected to the PC via the Problem Fault USB cable but is not discovered by the Symptoms: Vitalograph Webportal. • Power off the device before connecting to the PC. • Login into the Webportal with an Possible authorised login.
  • Page 21 Warning: No modification of this equipment is allowed. Any unauthorised changes to the VitaloJAK may compromise product safety and/or data and as such Vitalograph cannot be held responsible and the device will no longer be supported. Page of 36...

  • Page 22: Software Check

    Details are provided in site manuals. Any serious incident that has occurred in relation to the device should be reported to Vitalograph and authorities in the country of use. Refer to Vitalograph contact information at the start of this manual.

  • Page 23: Explanation Of Symbols

    Vitalograph VitaloJAK - Instructions for Use 09260 Issue 1 10. Explanation of Symbols 10.1. Standard Symbols Symbol Description Type BF equipment Class II Power rating Direct current Instructions for Use; operating instructions Manufacturer Date of Manufacture (include date in format yyyy-...

  • Page 24: Graphical User Interface Symbols

    A Global Leader in Respiratory Solutions General warning sign (yellow) Ingress Protection rating – IP22, protection against solids >12.5mm and vertically dripping water when IP22 the enclosure is tilted at an angle up to 15° from its normal position 10.2. Graphical User Interface Symbols Symbol Description Recording in progress...

  • Page 25: Additional Symbols Used On Device

    Vitalograph VitaloJAK - Instructions for Use 09260 Issue 1 Memory error (blue) Real time clock error (purple) 10.3. Additional Symbols Used on Device Symbol Description Cable Connection Battery Connection 11. Description of the VitaloJAK The VitaloJAK is a non-invasive battery operated device intended to acquire, record and store ambulatory cough sounds from patients for up to 24 hours.

  • Page 26: Indications For Use

    A Global Leader in Respiratory Solutions memory card or to internal memory for later playback, review, and analysis of the cough sounds on a windows based PC. The VitaloJAK is intended for use by technicians who are trained in the operation of Cough Recording Sessions. The VitaloJAK is not interpretative and it does not deliver a diagnosis. The VitaloJAK is not life supporting equipment, it does not screen, treat or prevent any condition or disease.
  • Page 27 Vitalograph VitaloJAK - Instructions for Use 09260 Issue 1 Maximum Test 24 hours, using 3 x AA Alkaline battery pack Duration False Positive Cough None (coughs are manually identified) Rate 1 x Battery Pack containing 3 x AA Alkaline Batteries. Power Supply USB powered during configuration/ download 5V/500mA.

  • Page 28: Contraindications, Warnings, Precautions And Adverse Reactions

    1. No modification of this equipment is allowed. Any unauthorised changes to the VitaloJAK 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 VitaloJAK has no serviceable parts. The device must be returned to the manufacturer at the end of the Study.
  • Page 29 Vitalograph VitaloJAK - Instructions for Use 09260 Issue 1 an attempt is made to re-use or re-attach a chest sensor the adhesive will no longer be effective, the chest sensor may fall off and the data may be compromised. 6. Ensure the device is not attached to the subject and is powered down prior to replacing the cough sensor/microphone cable assembly. ...
  • Page 30 30 cm (12 inches) to any part of the VitaloJAK including cables specified by Vitalograph. Otherwise, degradation of the performance of this equipment could result. 26. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation.

  • Page 31: Ce Notice

    28. In the unlikely event that there is any visible damage to the battery pack contact Vitalograph 24/7 support immediately. 29. Reprocessing of single use devices is not permitted. 14. CE Notice...
  • Page 32 A Global Leader in Respiratory Solutions EN 60601-1-2:2015 - Emissions tests Emissions Electromagnetic environment - Compliance test guidance The VitaloJAK uses RF energy only for its internal function. Therefore, its RF emissions are emissions Group 1 very low and are not likely to CISPR 11 cause any interference in nearby electronic equipment.

  • Page 33: Fda Notice

    USB data cable to resume normal operations. 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 VitaloJAK and result in improper operation.

  • Page 34: Eu Declaration Of Conformity

    A Global Leader in Respiratory Solutions 16. EU Declaration of Conformity Product: 7100 VitaloJAK 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 35: Guarantee

    7. To the maximum extent permitted by law, the Company does not accept liability for any consequential damages arising out of the use of, or inability to use any Vitalograph® equipment. This Guarantee is offered as an additional benefit to the Consumer’s statutory rights and does not affect these rights in any way.

Table of Contents