Vitalograph VitaloJAK 7100 Instructions For Use Manual Download Page 27

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ENG

Page

of 36

09260 Issue 1

Vitalograph VitaloJAK - Instructions for Use

Maximum Test

Duration

24 hours, using 3 x AA Alkaline battery pack

False Positive Cough

Rate

None (coughs are manually identified)

Power Supply

1 x Battery Pack containing 3 x AA

Alkaline Batteries.

USB powered during configuration/

download 5V/500mA.

Size

78mm x 108mm x 32mm (device)

Weight

165g – device only

240g – device with battery pack,

349g – device with battery pack,

sensor and pouch

Operating

Temperature

5–40ºC

Operating Humidity

15%–90%

Atmospheric pressure

700 – 1060hPa

IP rating

IP22 (protected against touch by

fingers >12.5mm and water spray <15

degrees from vertical).

Memory

SD Card, Size: min 4GB sufficient for

24 hour recording

Internal Memory: 32GB sufficient for

10 days of 24 hour recordings.

Write speed: 20 MB/sec

Communications

SD Card

USB 2.0/3.0 for data download and

device configuration. Custom USB

cable is required, supplied as part

of Site Kit (71210)

Sampling Rate

8 kHz

Summary of Contents for VitaloJAK 7100

Page 1: ...VitaloJAK Instructions for Use MODEL 7100 Copyright Vitalograph 2020 Current Edition Issue 1 24 Feb 2020 Cat No 09260...

Page 2: ...Support Telefon 49 40 547391 14 E mail support vitalograph de Vitalograph Inc 13310 West 99th Street Lenexa Kansas 66215 USA Toll Free 800 255 6626 Tel 913 730 3200 Fax 913 730 3232 E mail contact vi...

Page 3: ...tructions 13 3 4 Finishing a Cough Recording 14 3 5 Uploading Data 15 4 Cleaning Hygiene 16 5 Disposal 16 6 Power Management 17 7 Fault Finding Guide 17 7 1 Software Check 21 8 Customer Service 22 9 C...

Page 4: ...ENG 4 Page of 36 DT_0006 Issue 15 A Global Leader in Respiratory Solutions 1 Main Components Figure 1 Main components of the VitaloJAK...

Page 5: ...Flap 14 Pouch Insert 15 Sensor Cable 16 Chest Sensor 17 Air Microphone 18 PC running Vitalograph Web Portal 19 USB Data Cable 1 1 Features Use of cough sensor for cough detection Second audio recordi...

Page 6: ...k cover of the device using screwdriver provided Remove the back cover 4 If the device has previously been used remove the microphone and chest sensor wire and battery following instructions at Sectio...

Page 7: ...contains a used battery pack remove this by pushing down on the battery pack release catch and pulling back on the battery connector Note The battery pack connector has a locking mechanism to stop ac...

Page 8: ...pouch via the cable feed at the top 3 Plug the chest sensor and air microphone cable into the data cable connector on the device Note The cable connector has a locking mechanism to stop accidental dis...

Page 9: ...front of the device is used to navigate through the device menus The arrow symbols indicate the function of each key for menu navigation as shown in Figure 6 Figure 6 Menu Navigation using the Keypad...

Page 10: ...udio Levels 5 Return to Setup Menu Select Date Time 6 Check date and time are correct Adjust if necessary 7 Return to Main Menu 3 Operating Instructions 3 1 Positioning the Air Microphone and Chest Se...

Page 11: ...sor sticky pad 7 Clip the microphone to the outside of the subject s clothing between 4 and 6 inches 10cm and 15cm away from the subject s mouth Figure 8 Positioning the Chest Sensor and Air Microphon...

Page 12: ...cording 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 Figu...

Page 13: ...n 8 Verify recording has started by confirming the screen is blank and the LED light on the front of the device is flashing green 9 Place the device into the pouch then fasten it around subject s wais...

Page 14: ...phone must not be worn in the shower or bath during a recording 6 The subject should try to avoid noisy environments while wearing the VitaloJAK device For example the cinema driving with the windows...

Page 15: ...require excessive force Please push down on the release catch before removing 8 If an SD card was used follow site instructions regarding use of the SD card 3 5 Uploading Data 1 Disconnect the battery...

Page 16: ...aning Disinfection Methods Part Clean Low Level Disinfection Recommended Cleaning Low Level Disinfection Case exterior Clean Wiping with a 70 isopropyl alcohol impregnated cloth provides a suitable fo...

Page 17: ...the Power LED flashes RED and the device will not operate See Section 7 Fault Finding Guide Before turning off the device first allow any recordings to complete to avoid data loss Then turn off the de...

Page 18: ...battery pack A new battery pack is required for each recording session Problem Fault Symptoms The Idle Alert symbol Amber displays and buzzer beeps loudly Possible Solutions In probable order The devi...

Page 19: ...is reattached 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 devi...

Page 20: ...bable order Power off the device before connecting to the PC Login into the Webportal with an authorised login The PC does not have sufficient administration rights to install the required drivers Con...

Page 21: ...vice is left for 10 seconds it will shut down automatically and the recording will immediately end Problem Fault Symptoms Device freezes during configuration or data upload Possible Solutions In proba...

Page 22: ...in case of any potential issues Repairs should only be carried out by the manufacturer Customer Service contact for study sites using VitaloJAK is with the project team and site support Details are pr...

Page 23: ...ent Instructions for Use operating instructions Manufacturer Date of Manufacture include date in format yyyy mm dd USB connector The device must be taken to separate collection at the product end of l...

Page 24: ...Graphical User Interface Symbols Symbol Description Recording in progress Where the mute function is enabled symbol displays when the mute button is pressed At end of recording this symbol displays b...

Page 25: ...s lost due to data compression methods The VitaloJAK is capable of recording 24hrs worth of information continuously without the need to replace the battery pack The sensing of the coughs is provided...

Page 26: ...emory card for later playback review and analysis of the cough sounds on a windows based PC The subjects may be of any user population weight range health or condition 12 Technical Specification Produ...

Page 27: ...40g device with battery pack 349g device with battery pack sensor and pouch Operating Temperature 5 40 C Operating Humidity 15 90 Atmospheric pressure 700 1060hPa IP rating IP22 protected against touc...

Page 28: ...nto physical contact with the subject for equipment or system to perform its function 13 Contraindications Warnings Precautions and Adverse Reactions 1 No modification of this equipment is allowed Any...

Page 29: ...ernal memory or SD card 10 Contact the site administrator study coordinator if the chest sensor becomes detached if the VitaloJAK alarms during the recording or any other problems occur as the recordi...

Page 30: ...pervised when wearing the VitaloJAK 22 Only approved accessories from the manufacturer should be used with the VitaloJAK It may be unsafe to use accessories detachable parts and materials not describe...

Page 31: ...vate domiciles 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 hi...

Page 32: ...60601 1 2 2015 Immunity tests Immunity test Test level Compliance level Reached Electrostatic discharge ESD EN 61000 4 2 Contact 8 kV Air 2 kV 4 kV 8kV 15 kV Contact 8 kV Air 2 kV 4 kV 8kV 15 kV Power...

Page 33: ...on Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the VitaloJAK including cables s...

Page 34: ...is classified as IIa per Annex IX of the MDD also meets the provisions of the Essential Requirements Annex I via compliance with Annex II of the Medical Devices Directive as per Article 11 section 3a...

Page 35: ...period stated above provided that the failure can be recreated and the software has been installed and used in accordance with the user manual Notwithstanding this clause the software is not warrante...

Page 36: ......

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