insulCHEK DOSE User manual

Insulin Injection Tracker
User Manual
Doc.ID: DRAFT V.8.3.6Issued:2022-11

Innovation Zed Ltd.
NovaUCD, Belfield Innovation Park,
Belfield, Dublin 4,
Ireland
IC-Dose
Thank you for using InsulCheck DOSE. This User Manual provides important
information to help you use your InsulCheck DOSE correctly and get the most benefit
from its use. Before using the product, please read it carefully.
If you have any questions about this product, please:
•Consult our website www.innovationzed.com
•Email our Customer Support Team [e-mail]

Innovation Zed only accepts responsibility for the equipment’s safety, usability,
and performance if:
•the equipment is used in accordance with its intended use and
•the equipment is used in accordance with the product documentation
InsulCheck DOSE does not make any decisions or suggestions about your
injection regime.
IMPORTANT
Read all instructions and
warnings before use.

Table of Contents
Contents
1 Introduction 7
1.1 Definitions .................................... 7
1.2 General description......................... 7
1.3 Intended Use................................. 7
1.4 Intended Users .............................. 7
1.5 Normal use ................................... 8
1.6 Contraindications ........................... 8
2 Device Description 9
2.1 Package contents ........................... 9
2.2 Symbols ..................................... 11
2.3 InsulCheck DOSE terminology ........ 13
2.4 Insulin pen terminology................. 14
2.5 Supported pens ........................... 15
2.6 Function description...................... 16
2.7 Performance................................ 16
3 Operating instructions 17
3.1 First time use .............................. 17
3.2 Mount Device on the Injection pen .. 17
3.2 Normal Injection Routine ............... 19
3.4 Battery status.............................. 22
3.4 Charging..................................... 23
3.5 Bluetooth® pairing ....................... 24
3.5.1 Maximum number of pairings ...... 24
3.6 Clearing paired devices ................. 25
3.7 Changing Pen .............................. 25

3.8 Factory reset ............................... 26
4 Cleaning and care 27
4.1 General cleaning .......................... 27
4.2 Sensor Cleaning........................... 27
5 Disposal 28
6 General safety advice 29
7 Troubleshooting 30
7.1 Injection not detected ................... 30
7.2 Blinded sensor ............................. 30
7.3 Spillage ...................................... 30
7.4 System error ............................... 30
7.5 Unsuccessful pairing ..................... 31
7.6 Critical Battery............................. 31
7.7 Injecting while charging ................ 31
7.8 High temperature indication ........... 31
7.9 Low temperature indication............ 31
7.10 Long delay indication .................. 32
7.11 incorrect mounting indication ....... 32
7.12 firmware update indication........... 32
7.13 long delay injection indication....... 32
7.14 too fast dialling indication ............ 32
7.15 Sensor cleaning indication............ 32
8 Display guide 33
9 Contact information 35
9.1 Support ...................................... 35
9.2 Manufacturer ............................... 35
9.3 Warranty .................................... 35
9.4 Disclaimers ................................. 35
10 Technical specifications 36
10.1 Specifications............................. 36

10.2 Environment and operating .......... 36
10.3 Accuracy ................................... 36
11 Declarations 37

1 Introduction
1.1 Definitions
Device InsulCheck DOSE
User Insulin pen user, Patient or Operator
1.2 General description
InsulCheck DOSE helps you track your insulin injections. It can streamline your
diabetes management by automatically logging injections events into a paired
diabetes management app. You can easily identify the previous dosage amount
dialled and the time since last injection on the display, helping you to stay on top of
your injection routine. InsulCheck DOSE is clipped-on to your insulin injection pen.
InsulCheck DOSE must not be used as the only indicator to decide when or how much
insulin to inject. You must rely on your own memory and knowledge, your blood
glucose level and your healthcare provider’s advice when deciding to inject.
1.3 Intended Use
InsulCheck DOSE is an add-on device for insulin injection pens to support users by
automatically capturing and displaying injection event data, such as time of injection
and the dialled dosage.
InsulCheck DOSE does not change or modify the function of the injection pen, nor
does it make any decisions or recommendation as to the timing or dosage to be
administered.
The Device is intended to be used in common environments such as your home,
office, or school.
The Device is intended for users who see a benefit in logging their injection event
data. This data can be logged either manually by the user or automatically by wireless
transmission.
InsulCheck DOSE should not be used as the sole or primary source for informing
injection decisions.
1.4 Intended Users
InsulCheck DOSE is intended for people living with diabetes who are able to manage
their treatment without the use of the device, and their care givers.
The intended users are expected to be familiar with the normal aspects of insulin
usage and the operation of injection pens.

1.5 Normal use
InsulCheck DOSE is mounted on the insulin pen by the user. The device is on the pen
when injecting. The time since previous injection and dose dialled is displayed on the
display screen.
Once mounted, the device need not be removed from reusable pens. When used with
disposable pens, once the insulin runs out, the device is removed and mounted on a
new disposable pen.
InsulCheck DOSE has a lithium-ion battery that is rechargeable when a low battery
is indicated
Using Bluetooth® technology, data from the Device can be transferred to a
compatible connected app (e.g., smartphone app). For users who see a benefit to
logging their injection events to keep track of their usage behaviour and of monitoring
their drug adherence record.
1.6 Contraindications
InsulCheck DOSE should not be used by users who are unable to manage their
treatment without the use of the Device.

2 Device Description
2.1 Package contents
Included in the box is:
a) InsulCheck DOSE (Device)
b) Documentation (Quick Start Guide)
c) USB charging cable
Do not use the Device if packaging is damaged or opened
Do not use InsulCheck DOSE if any part appears to be broken or
damaged. InsulCheck DOSE supports a variety of insulin pens. Each
device designated to work with only one specific pen model (see section
2.3 for supported pens). InsulCheck DOSE cannot detect that it is fitted
on the wrong pen
Before using, please check that you have purchased the Device
designated for the model of pen you use.

It is your responsibility to ensure that you are using the correct Device for your pen.
Consult your healthcare provider if you are unsure which insulin pen model you are
using.

2.2 Symbols
The following table describes the meaning of the symbols used in the User Manual, the
Packaging and the Label on the bottom of the Device.
Symbol Meaning
This action is prohibited. User should read very carefully.
Important information, warning or precaution. User should read
carefully.
innovationzed.com/if
u-documents
Consult instructions before use,
electronic form available from http://innovationzed.com/ifu-documents
Name and address of manufacturer. Year-month of
manufacture.
Model number of the Device.
BLE (Bluetooth®Low Energy) name of the Device.
Rating of the USB charger.
Do not dispose as normal household waste. Dispose separately
as Electronic Equipment waste.
The Device Complies with relevant EU Regulations.
Do not use the Device if packaging is damaged or opened.
IP22 Degree of enclosure protection.
Protect Device from moisture.
Avoid using the Device under direct sunlight.
Range of temperature (upper and lower limit) to which the
Device can be safely exposed to during transportation and
storage.

Range of humidity (upper and lower limit, noncondensing) to
which the Device can be safely exposed to during
transportation and storage.

2.3 InsulCheck DOSE terminology
The following images describe the key components of InsulCheck DOSE.
①Display screen – Timer and other information are displayed on it.
②Charging indicator – Displays the charging status.
③Sleeve – The sleeve can only be fitted properly on a specific pen model.
④Reset button – Hole for accessing the reset button using a paperclip or similar tool.
⑤Sensor Windows – used by sensors to detect Pen motion.
⑥Bottom label – Carries Device identification and other important information.
⑦ Dust Cover – Protects the charging inlet.
⑧Sleeve Window – Aligns with Dose window of insulin pen.
⑨Pen Model – 2 digit code indicating insulin pen supported by the sleeve.

2.4 Insulin pen terminology
①Dose-knob – the knob at the end of the insulin pen which is dialled to adjust the
desired dosage of insulin.
②Dose-indicator – the number of dialled-out insulin units. After mounting the
InsulCheck DOSE on a pen, the dose-indicator is visible through the window in the
sleeve.
②
①
②
①

2.5 Supported pens
InsulCheck DOSE is clipped onto the insulin pen using the sleeve, hinge mechanism
and mounting mechanism.
The unique design of the sleeve means that the device will only fit properly and
operate correctly on the designated model of pen. The abbreviation for the pen names
the device is designated for, is embossed on the sleeve.
The following table provides a list of pen models supported by InsulCheck DOSE
together with their abbreviation.
Pen
Manufacturer
Pen model Pen
Code.
Supported
Drug
Variation
Novo Nordisk
NOVOPEN5
NP5
Novo Nordisk
Flextouch
FT
Eli Lily
Kwikpen
KP
Mix25
Mix50
U100
U200
Abasglar
Sanofi
Solostar
SS
Toujeo
Lantus
Ensure that the correct device variation is used with your pen

2.6 Function description
InsulCheck DOSE is clipped-on to your insulin injection pen. InsulCheck DOSE is
secondary aid in diabetes management, by providing information about the timing of
injections and number of units of insulin dialled.
You can easily identify the previous dosage amount dialled and the time since last
injection on the device display at any time, helping you to stay on top of your injection
routine.
The sleeve, hinge mechanism and mounting mechanism are used to clip the Device
onto the pen. Each Device is designated to be used with a specific model of insulin
pen. This is due to the unique design of its sleeve that will only fit properly on the
designated model of pen. The internal sensors detect dialling-in and out of the dose-
knob only if the Device is correctly mounted on the pen.
InsulCheck DOSE helps you track your insulin injections. It can also be used to
streamline your diabetes management by automatically logging injections events into
a paired with a compatible diabetes management app.
InsulCheck DOSE must not be used as the only indicator to decide when or how much
insulin to inject. You must rely on your own memory and knowledge, your blood
glucose level and your healthcare provider’s advice when deciding to inject.
2.7 Performance
When the operating instructions, safety regulations and care requirements are
properly followed, InsulCheck DOSE will continue to automatically detect and record
injection time, date and dosage dialled and if paired with an app, transfer data to
connected apps, as described in this manual during its service life.
Do not use the Device if you observe a deterioration in any of these
functions.
A decrease in charging interval can be expected due to normal battery degradation.
Contact our customer support team at [e-mail] if the Device does
not behave as specified in this manual, especially if proper screens are not displayed
or the detection threshold increases.
Nominal InsulCheck DOSE performance listed is based on standard test bench
conditions.
Dialled dosage detection
95% +/- 1U
Injection detection
99%

3 Operating instructions
3.1 First time use
Remove the protective strap around device
3.2 Mount Device on the Injection pen
Always ensure that the needle is covered before attching or removing
the device.
a. Align the dose-indicator window on the sleeve with the dose- indicator on the
pen. Confirm the chamfered edge of the InsulCheck DOSE is positioned near
the dose knob of pen.
b. Push the sleeve onto the pen
0

c.Press (click) together the mounting mechanism to fasten the Device on the pen
If mounted correctly the Chamfer ed of the device should be near the Injector
button of the pen as shown here.
On first mounting the device powers on and the InsulCheck insignia is displayed
The mounted-on pen animation is displayed when device is locked in place securely
to the injection pen. Followed by the dashed timer is displayed and dashed Dose
display since no injection has been detected yet
To save power, the screen will turn off after a few seconds.
Always ensure that the device is fitted firmly and securely when
attaching to a new pen
Dashed Timer Display
Dashed Unit Display
Mounting Successful Display

3.2 Normal Injection Routine
Ensure that the device is attached to the pen and the display area is face up the Display
will turn on and device will “wake-up” when the device detects any motion or when the
display is “double tapped”
NOTE: The device display must be on before dialling any dose. If the
device display is not on, double tap screen to turn on
When dialling out the dosage the InsulCheck DOSE will automatically begin tracking the
dosage dialled – it will display the image below while dialling.
When desired dose is set perform the injection according to your therapy
When injection is completed the timer resets due to the new injection and starts
counting up.
After 10 Sec the display will also show the number of units dialled for the last

injection and then toggle between the elapsed time and the dose every 5 sec.
The display will automatically dim and turn off after 20 Sec to conserver power.
For effective tracking of injection dose, do not combine priming amount
into amount dialed for medication.
3.3 Checking last injection status
Ensure that the device is attached to the pen and ensure that the display area is
always face up and double tap the screen to turn on the display and wake up device.
If there are no warnings, the device display will turn on and show the elapsed time
since the last injection and after 3 sec will display the last dose
day hr min
Time elapsed since the last injection dosage
last injection
The display will automatically dim and turn off after 20 Sec to conserver power.
Tap 2
times