Vitalograph VitaloJAK 7100 User manual

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

ENG
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A Global Leader in Respiratory Solutions
Vitalograph Ltd, UK
Maids Moreton, Buckingham
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.co.uk
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph Ltd, International
Maids Moreton, Buckingham
MK18 1SW
England
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.eu
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph GmbH
Rellinger Straße 64a
D-20257 Hamburg
Germany
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.de
Technical Support
Telefon: [phone]
E-mail: [email protected]
Vitalograph Inc.
13310 West 99th Street
Lenexa, Kansas, 66215
USA
Toll Free: 800 255 6626
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.com
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph (Ireland) Ltd
Gort Road Business Park
Ennis, Co Clare, V95 HFT4
Ireland
Tel: [phone]
Fax: [phone]
E-mail: [email protected]
www.vitalograph.ie
Technical Support
Tel: [phone]
Email: [email protected]
Vitalograph Ltd, Hong Kong/China
P.O. Box 812
Shatin Central Post Oce
Hong Kong
E-mail: [email protected]
www.vitalograph.cn
Technical Support
Tel: [phone]
Email: [email protected]
© Copyright Vitalograph 2020
Current Edition (Issue 1, 24-Feb-2020)
Cat. No. 09260
Vitalograph is a registered trademark.
Vitalograph Branch Addresses

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Contents
1. Main Components ................................................................4
1.1. Features ................................................................5
2. 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
2.4. Setup Menu ...........................................................9
3. Operating Instructions........................................................10
3.1. Positioning the Air Microphone and
Chest Sensor ......................................................10
3.2. Starting and Stopping a Recording....................11
3.3. Subject Instructions............................................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. Consumables and Accessories .........................................22
10. Explanation of Symbols......................................................23
10.1. Standard Symbols...............................................23
10.2. Graphical User Interface Symbols .....................24
10.3. Additional Symbols Used on Device..................25
11. Description of the VitaloJAK..............................................25
11.1. Indications for Use..............................................26
12. Technical Specication ......................................................26
13. Contraindications, Warnings, Precautions and
Adverse Reactions..............................................................28
14. CE Notice.............................................................................31
15. FDA Notice ..........................................................................33
16. EU Declaration of Conformity.............................................34
17. Guarantee ............................................................................35

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1. Main Components
Figure 1 Main components of the VitaloJAK

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1 LCD screen
2 Event Buttons 1, 2 and 3
3 Mute / Privacy Button
4 Keyswitch
5 SD Card Slot
6 LED Light
7 Battery Compartment
8 Back Cover Screw
9 Back Cover
10 Cable Connector
11 Channel for Cable
12 Pouch
13 Pouch 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 recording using a lapel microphone for
validation purposes
• Real time clock
• 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.

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To get the VitaloJAK ready for use:
• Check that the contents of the packaging correlate with the site
and test kit contents specied in the site manual.
• Check the serial numbers of the VitaloJAK, Site Kit and Test Kits
against the packing list in your shipment. Serial numbers should
match.
• Please read, retain and refer to all study material, product
information and instruction manuals that are sent to you.
2.1. Connecting the VitaloJAK to a PC
1. Follow the site manual instructions to access the
Webportal.
2. If the device is powered on, use the key to turn it off prior
to connecting it to the PC. The red dot on the keyswitch
should line up with the ‘O’ mark on the case when the
device is powered off.
3. Unscrew the back 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 Section 3.4 and 3.5. Before setting up the
VitaloJAK for a different subject, clean the device according
to cleaning and hygiene instructions at Section 4.
Note: The data cable, chest sensor/air microphone and battery
pack connectors have a locking mechanism to stop accidental
disconnection or damage.
5. For studies using a removable SD card instead of the
internal ash memory, an SD card should be inserted at
this stage using SD Card Tool provided.
6. Connect one end of the data cable to the device via the
cable connector (Figure 2) and the other to the PC used
to access the Webportal. The battery should be detached
when the VitaloJAK is connected to the web portal.
7. Follow the instructions on the Webportal.
Note: Do not congure the device for a subject until a recording is
due to take place.

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Figure 2: Removing the Back Cover for Connection of the Data Cable
2.2. Fitting a New Battery Pack
A new battery pack is required for each recording session.When
replacing the battery pack, the device should be powered down
and should not be attached to the subject. If attached to a PC,
disconnect the USB cable from the device.
1. Unscrew the back cover of the device using screwdriver
provided and remove.
2. If the device 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
accidental disconnection or damage.The release catch must be
pushed down to remove.
3. To insert a new battery pack, connect the battery pack
connector into the battery connection point on the device.
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.
5. Proceed to instructions for connecting the air microphone
and chest sensor.

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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.
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 disconnection or damage.To disconnect, use one hand to
slide forward the data cable release catch while pulling back on the
connector to release the data cable with the other hand.
Figure 4: Connecting the Air Microphone and Chest Sensor
4. Attach the back cover and fasten it closed with the screw.

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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
key for menu navigation as shown in Figure 6:
Figure 6: Menu Navigation using the Keypad
1 Return to Previous Menu
2 Navigate down between options
3 Navigate up between options
4 Enter current selection/ Mute when recording
1 2 3 4

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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. On Setup Menu select ‘Audio Level’.
4. On Audio Levels screen ensure both the Chest Sensor
‘C’ and Air Microphone ‘A’ bar graphs are responding to
sound.
Figure 7: Audio 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 Sensor
A new air microphone and chest sensor should be used for each
subject/test.
Note: The microphone and sensor are to be positioned immediately
prior to starting the recording.
1. Prepare the area ensuring it is dry, free from excess hair,
jewellery and tight clothing.
2. If the chest sensor is being replaced with a new sensor the
healthcare professional should inspect the condition of the
skin for damage or irritation.

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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.
3. Feed the lapel microphone and chest sensor wires
underneath clothing, up to the collar.
4. On the chest sensor, peel back the larger portion of the
protective covering.
5. Adhere the chest sensor to the subject so that the sticky
pad touches the bottom of the suprasternal notch and the
sensor wire hangs down. The suprasternal notch is a large,
visible dip located between the neck and the collarbone.
6. Remove the remaining protective covering from the sensor
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 Microphone
8. Use the tape provided to secure the chest sensor wire in
place. This will prevent excess cable from pulling on the
sensor causing it to become detached.
Note: When tting the cable to the subject, the microphone clip and
any excess cable must be secured to avoid a choking hazard from
the clip and to mitigate strangulation risk from excess cable. Children
must be supervised while wearing the VitaloJAK.
3.2. Starting and Stopping a Recording
1. Ensure that the chest sensor/microphone cable is
connected and a new battery pack is inserted as per
Section 2, Set Up.
2. Power on the device 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.

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3. When the Main Menu is displayed, select ‘Start Recording’.
Figure 9: Main Menu
4. The Subject ID screen is displayed.Conrm subject and
visit details.
Note: If any of the subject or session details are incorrect, refer to the
site manual for guidance.
Figure 10: Subject ID
5. The Date & Time screen is displayed.Conrm date and
time are accurate.
Figure 11: Date and Time Conrmation

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6. The Recording Duration Screen is displayed.Conrm the
recording duration to begin the recording.
Figure 12: Recording Duration Screen
7. The ‘Recording’ screen is displayed briey per Figure 13,
before going blank.
Figure 13: Recording Screen
8. Verify recording has started by conrming the screen
is blank and the LED light on the front of the device is
ashing green.
9. Place the device into the pouch then fasten it around
subject’s waist and provide guidance to subject for
recording period. To prevent tampering, the pouch may be
secured with a zip tie.
10. The device automatically powers down after the full
recording is complete. No user interaction is required.
3.3. Subject Instructions
Requirements for subject use of the VitaloJAK device are study

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specic 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.
2. The subject may unclip or adjust the pouch if required for
comfort but may not remove the device from the pouch.
The zip tie tted on the pouch may only be tted and
removed by the healthcare professional. If required for
comfort overnight, the pouch may be placed on a bedside
locker, with the audio microphone clipped to the lapel of
the user’s nightclothes or edge of the pillowcase.
3. The chest sensor must remain in place for the entire
recording period.
4. The device must be kept dry.
5. The VitaloJAK, chest sensor and air microphone 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 down, the gym, or using the hair dryer.
3.4. Finishing a Cough Recording
1. The device automatically powers down after the full
recording is complete. (Duration is set according to the
study requirement).
2. When recording has stopped the screen displays
‘COMPLETE’ for 5 seconds and shows recording duration
in the format hh:mm:ss. The LED light on the front of the
device shows a solid green light.
3. The VitaloJAK device must be checked on return to the
clinic to ensure the recording has stopped.
Note: The device, chest sensor and air microphone may only be
removed from the subject when the indicator light is solid green.
4. Unclip the air microphone from the subject’s clothing and
detach the chest sensor.
Note: Using clean water or saline solution softens the adhesion of
the hydrocolloid on the chest sensor and tape, making removal easier
and reducing the risk of skin damage.

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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.
6. When the device is not attached to the subject and is
powered down, unscrew the back cover of the device using
screwdriver provided and remove.
7. To disconnect the sensor/microphone cable, slide forward
the cable release catch while pulling back on the connector
to release the cable.
Note: Removal of the USB Cable/ Chest Sensor and Microphone/
Battery pack from the VitaloJAK should NOT 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 pack by pushing down on the
battery pack release catch and pulling back on the battery
connector to remove.
2. Using the USB cable supplied, connect the VitaloJAK to
a PC running the Webportal to upload data. Follow the
instructions in the site manual and the web portal wizard.
The battery should be detached when the VitaloJAK is
connected to the Webportal.
Figure 14: Removing the battery pack and connecting the USB cable
3. When the data has uploaded, disconnect the USB cable
from the PC and then detach it from the device by sliding
forward the release catch while pulling back on the
connector to release the cable.

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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.
The body of the device may be cleaned with a 70% isopropyl alcohol
wipe. Cleaning should be completed between subjects/ recordings
to reduce risk of cross contamination.
The VitaloJAK pouch should be replaced if visibly soiled.
Table ofCleaning/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 form of cleaning
and disinfection.
5. Disposal
Devices and used accessories including chest sensor/air
microphone assemblies and used battery packs must be kept until
the end of the study to allow investigation in case of any potential
issues.
VitaloJAK devices and accessories including data cables, pouches,
keys, screwdrivers and unused test kits should be returned to the
manufacturer after use.
At the end of the study:
• Used chest sensor/ air microphone assemblies may be
disposed of according to local guidance for disposal of
healthcare waste.
• Used batteries may be disposed of according to local guidance

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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 conguring the device
for each recording session. Ensure the device is not attached to the
subject when changing the battery pack.
• When powered on and not recording, the Power LED is GREEN.
• When powered on and recording, the Power LED ashes GREEN.
• When an error state exists, the Power LED ashes RED.
If the battery pack is low on power, the device reports a Low Battery
fault, the Power LED ashes RED and the device will not operate.
See Section 7, Fault Finding Guide.
Before turning off the device, rst allow any recordings to complete
to avoid data loss. Then 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.
To turn on the device, turn the key so that the red dot on the
keyswitch lines up with the ‘I’ mark on the case.
7. Fault Finding Guide
Site manuals contain details for study site actions on encountering
a fault with the VitaloJAK. The following are generic fault symptoms
and possible solutions.
Problem Fault
Symptoms:
• Device does not power on
• Device powers on but does not stay on or
is not operational, e.g. can’t select a menu
item or the LCD display is corrupted.
Possible
Solutions: (In
probable order)
• The battery pack may be low/dead,
replace battery pack. A new battery pack is
required for each recording session.
• Electronics failure - contact support.

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Problem Fault
Symptoms:
• Memory error symbol displays and LED
ashes RED.
Possible
Solutions: (In
probable order)
• Data has not written to memory. Shutdown
the device and contact support.
Problem Fault
Symptoms:
• Battery Low Error symbol displays and the
LED ashes RED.
Possible
Solutions: (In
probable order)
• Replace the 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 device has been left idle for more
than 5 minutes while powered on and
without starting a recording, pressSelect
(forward keypad arrow) to resume normal
operation.
Problem Fault
Symptoms:
• Insert cable symbol displays and the LED
ashes RED.
Possible
Solutions: (In
probable order)
• The cable is not connected correctly to the
device. Check the cable connection.
• The cable is faulty. Replace the cable.

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Problem Fault
Symptoms:
• Attach cover warning displays and the
LED ashes RED.
Possible
Solutions: (In
probable order)
• The back cover of the device is not
securely attached to the device. Check
that the screw is suciently tightened (do
not overtighten).
• The door sensor has developed a fault,
contact support.
• If not recording, normal operation will
resume when the back cover 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 device and contact Vitalograph
support.
Problem Fault
Symptoms:
• Internal Memory Full Error displays and
the LED ashes RED.
Possible
Solutions: (In
probable order)
• Internal memory is full. Upload stored
recordings using the Webportal.
Problem Fault
Symptoms:
• Insert SD Card symbol (Green) displays
and the LED ashes RED.
Possible
Solutions: (In
probable order)
• The SD Card is full. Replace the SD Card.
• An SD Card is required but not inserted.
Insert an SD Card.

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Problem Fault
Symptoms:
• Remove SD Card symbol (Red) displays
and the LED ashes RED.
Possible
Solutions: (In
probable order)
• Internal memory (not the SD Card) is to be
used for the recording. Remove the SD Card.
Problem Fault
Symptoms:
• Device is connected to the PC via the
USB cable but is not discovered by the
Vitalograph Webportal.
Possible
Solutions: (In
probable order)
• Power off the device before connecting to
the PC.
• Login into the Webportal with an
authorised login.
• The PC does not have sucient
administration rights to install the required
drivers. Contact your IT administration.
• Contact support.
Problem Fault
Symptoms:
• On start-up the amber warning symbol
with “Rec Failed”appears and the LED
Flashes RED.
Possible
Solutions: (In
probable order)
• Recording was interrupted and the device
powered down. Press select (forward keypad
arrow) to acknowledge the notication and to
resume normal device operation.
Problem Fault
Symptoms:
• Real Time Clock symbol displays and the
LED ashes RED.