Renew Health Zensor User manual

The world’s rst 3 lead
14 day continuous ECG
and remote event device.
A very positive and quick way to
get diagnosed.

www.zensordevice.com
Patient Instruction Booklet

The Zensor™ monitoring device
is a small, lightweight, wearable,
non-invasive, re-chargeable battery
operated portable system connected
to an electrode accessory (single-
use disposable Intelesens Zensor™
electrode) which in turn is in contact
with the patient’s body.
The device is to be used in the
patient’s home environment to provide
clinicians with patient physiological
data, while allowing for patient
mobility. The Zensor™ Monitoring
System provides full disclosure ECG
and cardiac event monitoring for adult
patients (18 years+).
The physiological parameters
monitored include ECG and respiration
waveforms, heart rate and respiration
rate, as well as lethal and high acuity
arrhythmias (Asystole, Tachycardia,
Ventricular Fibrillation, Bradycardia
and Atrial Fibrillation).
The Zensor™ monitoring device has
the option to store full disclosure ECG
& respiration data and/or wirelessly
transmit pre-dened event alerts to
the Intelesens Zensor™ online system
for review by healthcare practitioners.
All physiological data stored on the
device can be downloaded for viewing
on Intelesens Zensor™+ (Ambulatory
ECG Full Disclosure ECG and Event
Viewer) for later analysis by a clinician.
Any events or variations in
physiological readings are not
intended to be used to summon
emergency care.
| © 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A
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The Zensor™ Device
The Zensor™ device is a wireless patient monitor that records every
heartbeat. Each time you press the button or if the Zensor™ device
automatically detects an irregular heart rhythm, your data will be
stored. Alternatively, the arrhythmia (the irregular or abnormal heart
rhythm) can be transmitted (via the dedicated Mobile Wi-Fi unit) to the
Zensor™ device monitoring station and your healthcare provider will
receive a report detailing the arrhythmia.
Set up the Zensor™ device Apply the rst set of Zensor™
device patches
Go through the operating
instructions with you
Contact your healthcare provider if you need more patches or if you have any questions.
What is the
ZensorTM Device
Initially, your
healthcare provider will
© 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A | 3

The Zensor™ device monitoring system consists of the following components:
oZensor™ electronic unit and two batteries (rechargeable)
oCustom made ZensorTM patches
Accessories required to charge and transmit your heart rhythm data includes:
oCharging dock with power supply and mains lead
oMobile Wi-Fi, charging cable and three-pin plug
Only use the accessories supplied with the Zensor™ Device Monitoring System.
ZensorTM Device
Monitoring System
A very positive and quick way to
get diagnosed.

| © 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A
4

1
32
6
4
5
ZensorTM Device
Electronic Unit and
Rechargable Battery
1On/Off Button and Event Button
2Status Light
3Status Light
4Battery
5Five Connection Studs (Electronic Unit)
6Charging Dock (with Battery)
**Not Pictured: Power supply and mains lead for battery charger.
© 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A | 5

ZensorTM Device
Patch Units
Mobile
Wi-Fi Unit
7Right Patch (RA)
8Left Patch (LA)
9Larger Patch (LL)
10 Five Connection Studs
(embedded on LL marked patch)
11 Screen
12 On/Off button
**Not Pictured: Charger cable and three
pin plug.
RA LA
7
9
8
10
11
When wearing the system, you should have the
three patches placed on your chest and abdomen
with the Zensor™ electronic unit attached – this is
your Zensor™ device.
RA LA
LL
12
| © 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A6

© 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A | 7

DETERMINE PATCH LOCATION
oPlan position of where patches will be placed before removing
the liners.
oThe patches should only be placed on healthy, intact skin.
RA LA
1
SKIN PREPARATION
oInspect the area to ensure the skin is:
oIntact
oHairless
oIf required, remove chest hair.
oIf required, clean skin using soap and water.
oAllow skin to dry completely.
2
APPLYING ZENSOR™ DEVICE PATCHES
oRemove the patch liners to expose the adhesive.
oPlace patches in the recommended position.
oPress rmly across each patch for 10 seconds.
oIf required, coil and tape the excess wire to the skin.
RA LA
:10
3
RA LA
4a
RA LA
4b
RA LA
5
ATTACH ZENSOR™ ELECTRONIC UNIT
oLine up the Zensor™ electronic unit studs with the magnetic studs on
the patch.
oConnect the Zensor™ electronic unit to the patch.
oGently lift the edges of the electronic unit to conrm all ve
connections are made. (Step 4a)
oTurn on the device with a single press of the BLUE button. (Step 4b)
EVERYTIME A SYMPTOM IS FELT
oPress the BLUE button once.
oThere will be a single beep.
oRemain still for 30 secs while the Zensor™ device records your heart
rhythm.
Using your
ZensorTM Device
| © 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A
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RA LA
6
:10
8
9
WHEN SHOWERING
oRemove the Zensor™ electronic unit from the patches.
oKeep patches on the body.
oTurn the Zensor™ electronic unit off by pressing and holding the ON/
OFF button for 10 seconds.
oShower for a short period (5 minutes) only.
oKeep your back to the shower as much as possible.
oKeep soaps/shampoo away from the patches.
oDry the patches with a gentle ‘patting’ motion.
oReturn the Zensor™ electronic unit to the magnetic stud patch and
turn unit back on by pressing the ON/OFF button.
CHANGING BATTERIES ON THE ZENSOR™ DEVICE
oTurn the Zensor™ electronic unit off.
oPress and hold the BLUE button for 10 seconds.
oAll LED lights will now turn off.
oDetach the ZensorTM electronic unit from the body.
oRemove the battery from the electronic unit. (Step 7a)
oPlace the depleted battery in the charging dock. (Step 7b)
oConnect the mains lead to the wall socket and turn on the mains
power.
oA red LED will light up on the power supply to indicate charging.
TURN ZENSOR™ DEVICE OFF (OR END OF WEAR)
oPress and hold the BLUE button for 10 seconds.
oAll LED lights will now turn off.
RETURNING THE ZENSOR™ DEVICE TO YOUR DOCTOR
oEnsure the Zensor™ electronic unit, batteries, charging cables etc. are
placed back in the case and bring back to your doctor who prescribed
the Zensor™ device for you.
7a
7b Note: Please follow the sequence below to ensure the battery charges successfully:
a. Place the battery into the charging dock BEFORE connecting to the mains power.
b. Do not remove the battery from the charging dock until fully charged - as indicated
by green light on the power cable.
© 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A | 9

Charging the
ZensorTM Battery
Turn Zensor™ Device Off
Hold the blue button on the electronic unit down for 10
seconds. You will hear three descending beeps. The lights will
go from blue and green to off.
Remove Battery
Holding the electronic unit and battery, slide the battery away
from the electronic unit.
Charge Battery
1. Place the low charged battery in the charging dock,
pushing down to ensure a good connection.
2. Connect the power supply to the back of the charging dock
and insert the mains lead into the power supply.
a. Connect the mains lead to the wall socket in your home
and turn on the power at the mains. Place the battery into
the charging dock BEFORE connecting to the mains power
b. Check that the light on the power supply is red to
indicate charging.
The battery will take around 4 hours to recharge. The light on the power supply will
change to GREEN to indicate that it is fully charged.
Insert Battery
Slide a fully charged battery onto the electronic unit until
secured in place.
It is easier to see the guides on the electronic unit when the magnetic connectors are
facing upwards.
Turn Zensor™ Device On
Ensure the battery is connected and press the blue button.
You will hear three ascending beeps. The lights will turn
orange and then green. Green tells you that Zensor™ device
is ready to record your data and is operating normally.
:10
TIP
TIP
| © 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A
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Troubleshooting the
ZensorTM Device
1
3
2
1On/Off Button and Event Button
(blue button)
2Orange to Green LED
3Blue LED (on while waiting to
transmit data)
Troubleshooting
© 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A | 11

  Ascending Tone  1 Beep Device turning on
No sound Normal operation
Slow Flash No sound Device connecting to Wi-Fi
Fast Flash No sound Data transferring via Wi-Fi
No sound Data stored on device that has not
transmitted
 1 Beep Pressing the ON/OFF and EVENT button
  Repeated Long Beep Low battery

Slow Flash  Repeated Long Beep Critical battery*
Slow Flash  Repeated Short Beep Error indication**
  Descending Tone Device turning off
The ZensorTM device provides
visual and audible status
indications as follows:
* Device is no longer monitoring. Change battery.
**This indication may last approximately 6 seconds. If the error still exists after 6 seconds the
indication will be repeated. In this instance, switch the device off and remove the battery. After 10
seconds reinsert the battery, and switch the device on. Monitoring should then be continued. If the
error persists, contact your clinician.
| © 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A
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 Zensor™ device did not follow normal start-up sequence
Indication Solutions
The LEDs did not
turn on
Remove and reinsert the battery. Press the blue button again for
approximately 1 second.
The LED stayed
orange
Wait for 30 seconds. If it remains orange, turn Zensor™ electronic unit off
and remove battery. After 10 seconds re-insert the battery and turn back on.
If the error persists, contact your clinician.
Other indication Review the Zensor™ device indications table and the rest of the
troubleshooting section to determine if the indication is covered. If not,
contact your clinician to report unexpected operation.
 Zensor™ electronic unit will not switch on
Possible Causes Solutions
The battery is not
inserted correctly
Remove and reinsert the battery. When sliding the battery on, it is easier to
see the guides on the device when it is turned so the label is facing upwards.
The battery is at Conrm the battery is at by placing in the charging dock. The LED should
turn red if charging.
The blue button
wasn't pressed
Press the blue button on the front of the device. An ascending tone should
be heard when the button is pressed.
 Zensor™ electronic unit will not switch off
Possible Causes Solutions
The blue button has
not been held down
for a long enough
period
Hold the blue button down on the device for over 10 seconds.
No obvious cause Remove the battery from the device.
Troubleshooting: ZensorTM Device
© 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A | 13

 Zensor™ electronic unit is beeping
Possible Causes Solutions
One long beep every
second: The battery
is low
Replace the battery with a charged battery and insert the low battery in
the charger
One short beep every
second with orange
and blue alternate
ashing LEDs: Error
indication
If the indication does not stop after 6 seconds, turn Zensor™ electronic
unit off, remove battery. After 10 seconds re-insert the battery and turn
back on. If the error persists, contact your clinician.
 Cannot remove the battery from the device
Possible Causes Solutions
The grips on the
side of the battery
have not been used
Use the grips on the side of the battery to help to remove it.
Do not have the
required strength to
remove the battery
Seek assistance from a friend or family member to help remove the battery.
 Cannot connect Zensor™ electronic unit to the patch
Possible Causes Solutions
Unable to line the
device up with the
patch
Use a mirror to help with stud alignment. Line two of the studs up carefully
and the rest of the studs should nd themselves more easily. If still
unsuccessful, seek assistance from a friend or family member.
The patch is not on
the attest surface
of the abdomen
(stomach) area.
Apply a new patch ensuring the studs are on the attest area of the body.
 Zensor™ electronic unit exposed to water (bath or shower, etc.)
Possible Causes Solutions
Zensor™ electronic
unit is not to come
into contact with
water
Contact your clinician.
| © 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A14

Troubleshooting: ZensorTM Patches
 Electrode was submerged in water (bath, swimming, etc.)
Indication Solutions
Electrode is not to be
submerged in water
Replace all the Zensor™ device patches.
 Consistently poor electrode adhesion
Possible Causes Solutions
Skin type is resulting in
adhesion not lasting as long
as normal
If happy to do so, keep replacing the patches when appropriate.
 The patches are causing a bad skin reaction
Possible Causes Solutions
Skin has reacted against the
patch causing bad irritation
If required, discuss the irritation with the clinician in charge.
Troubleshooting: ZensorTM Electronic Unit
Battery Charging
 Difculty charging the battery
Indication Solutions
Order of battery charging
instructions were not
followed
Turn the power off and on at the mains switch.
The battery is not inserted
into the charger correctly
Remove the battery and reinsert ensuring good connection. Putting
slight downward pressure on the battery can help to ensure
adequate battery connection with the charger.
The cables are not connected
correctly
Remove and reinsert all the charger connections ensuring each one
is connected securely.
The power is not switched on
at the mains
Turn the power on at the mains switch.
© 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A | 15

Troubleshooting: Mobile Wi-Fi
 Wi-Fi Indication
The Mobile Wi-Fi has a battery life of 10 hrs. It is recommended that you leave the Mobile Wi-Fi unit
plugged in and charging when you are at home. See table below for explanation of Mobile Wi-Fi
display symbols
 Mobile Wi-Fi Safety information
· Keep the device away from water, re, humidity or hot environments
· Do not attempt to disassemble, repair or modify the device
· Do not use damaged charger or USB cable to charge the device
· Do not use the device where wireless devices are not allowed
Indicates signal strength of the current
network
4G/3G Indicates successful network connection
RIndicates you are roaming
Indicates Wi-Fi status
100%
Displays the remaining battery power
| © 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A16

Frequently
Asked Questions
 What is the Zensor™ device doing?
The Zensor™ device is recording every heartbeat. Your doctor will use this
information to determine your medical treatment.
 How long do I have to wear the Zensor™ device?
Wear the Zensor™ device for the number of days prescribed by your doctor.
 How do I know the Zensor™ device is working?
A continuous green LED will be visible on the Zensor™ device. Occasionally,
you may notice a second blue LED. This is all part of the normal Zensor™
device operation.
 Can I go about my normal day-to-day routine?
Yes, but activities that cause you to sweat excessively may shorten the wear
time of the Zensor™ device patches.
 How often should I change the patches?
The patches may stay on for an average of 2 - 7 days, depending on each
individual’s skin type. However, excessive sweating can cause the patches to
become loose. If this happens and the patches lift off the skin by more than
1cm, replace all the patches. Remove each patch slowly, taking care not
to damage the skin. Follow the instructions on the quick start guide when
applying new patches.
 Can I wear the Zensor™ device in the shower?
No, the Zensor™ electronic unit is not waterproof and it must be removed
prior to showering. However, the patches may be worn in the shower. Turn off
the Zensor™ device and remove the electronic unit from the patch. After you
shower, dry the patches with a gentle ‘patting’ motion. Reconnect the Zensor™
electronic unit to the lower large patch and turn back on.
Frequently Asked Questions
© 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A | 17

 Can I go swimming/have a bath with the Zensor™ device?
No, the Zensor™ electronic unit is not waterproof and cannot be worn whilst
swimming or in the bath. Also, if the patches are submerged (swimming or in
the bath), they may stop functioning correctly or detach from the skin.
 What should I do if I feel a symptom?
Press the blue button (see Your Zensor™ Electronic Unit image at beginning
of the troubleshooting section of this booklet) as shown on the Zensor™
electronic unit picture.
 How often should I change the battery?
Change the battery every 24 hrs. Then, place the used battery in the battery
charger to allow it to recharge (see Charging the Battery under Your Zensor™
Device section of this booklet).
 Will the Mobile Wi-Fi show any lights or make any sounds?
No, the Mobile Wi-Fi will not make any sounds. See the Troubleshooting
section of this booklet for an explanation of the screen symbols.
 How often should I charge the Mobile Wi-Fi?
Charge the Mobile Wi-Fi unit when you see the battery indicator running less
than 50% – the battery usually lasts 10 hrs. It is recommended that you plug
the Mobile Wi-Fi in each day to charge, similar to how you would charge a
mobile phone.
 When I leave my home, do I have to bring the Mobile Wi-Fi with me?
No, it is not necessary to bring the Mobile Wi-Fi with you. If you feel any
symptoms, just press the blue button on the Zensor™ device and it will store
or mark the event data. When you return home, the Zensor™ device will
automatically ‘talk’ to the Mobile Wi-Fi, and transmit the data to the Zensor™
device monitoring station.
| © 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A18

 Will I experience any adverse effects from wearing the Zensor™ device?
It is normal for some people to experience minor itching or slight skin
redness in response to wearing the device patches. If the patches become
very itchy and uncomfortable to wear, please remove them carefully.
Return the Zensor™ device kit to your doctor and ask your nurse/doctor to
check your skin.
 Can I travel with the Zensor™ device?
Yes, you can y while wearing your Zensor™ device. Simply remove the
Zensor™ electronic unit, turn the device OFF, and place in the ‘security bin’
whilst you go through security. Leave the patches on your body (similar to
procedure you would follow with the device when having a shower). Also
turn off the Mobile Wi-Fi unit during ight. Keep both devices OFF until you
have completed your ight. Then after your ight, turn back on the Zensor™
electronic unit and place back on your body. Turn back on the Mobile Wi-Fi
unit which is enabled for roaming in the USA & Europe.
 What will I tell airport security staff if asked about my Zensor™ device wear?
You can explain to staff that you were prescribed the Zensor™ device by
your doctor to monitor your heart. You can show airport security staff the
statement at the back page of this booklet which describes that this device
has been prescribed by your doctor to monitor your heart.
© 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A | 19

| © 2018 ZensorTM Device www.zensordevice.com PN 1265 Rev A20