ESYSTA BT Pen Manual de usuario
Operating instructions
ESYSTA®BT Pen
ESYSTA®BT Pen, example with adapter B and holder A/B
Threaded rod
Cartridge stamp
Needle side of the cartridge
Pen body
Adapter
Holder
Insulin cartridge
Cap
lESYSTA®BT Pen (insulin pen)
lHolder A/B
lHolder C
lMarkers for colour identication
lCase
lOperating instructions
Contents of the retail packaging:
Only use the ESYSTA®BT Pen if the retail packaging is undamaged.
Any stated brand names and trade marks are the property of the respective owners.
Issue date: 01 August 2016 / V 01.00
205-40-006-02-a
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1. Introduction 6
2. Correct use 7
2.1 ESYSTA®BT Pen 7
2.2 ESYSTA®Adapter (disposable adapter) 7
2.3 Data transfer 8
2.4 Information for doctors and medical sta 8
3. Information on safe use 9
3.1 Risks associated with its use 12
4. General information 13
5. Components of your ESYSTA®BT Pen 14
6. Commissioning your ESYSTA®BT Pen 15
6.1 Choosing the correct ESYSTA®Adapter 16
6.2 Choosing the holder 17
6.3 Inserting the insulin cartridge 18
6.4 Marker 19
6.5 Attaching the needle 21
6.6 Switching on the ESYSTA®BT Pen 21
6.7 ESYSTA®BT Pen pre-set venting 23
6.8 Marking and carrying out additional venting 23
6.9 Setting the units for subcutaneous injections 24
6.10 Injection procedure 26
6.11 Completing the injection process 28
6.12 Cancelling the setting process 29
6.13 Temperature sensor 30
Contents
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7. Changing the insulin cartridge 31
7.1 Continuing with the same insulin manufacturer 31
7.2 Changing the insulin manufacturer 32
7.3 Important safety information about changing the cartridge 32
8. Changing the battery 33
9. Enabling and disabling data transfer 35
9.1 Enabling the Pen-smartphone connection (“bonding”) 35
9.2 Disabling the Pen-smartphone connection (cancelling "bonding”) 37
9.3 Data memory 38
10. Display and error messages 39
11. Guarantee 43
12. Period of use 44
13. Technical data 45
14. FAQs 46
15. List of compatible insulin preparations 50
16. List of compatible needles 52
17. Index 53
Manufacturer's contact details 56
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1. Introduction
Your ESYSTA®BT Pen is a device for injecting insulin. As a component of
the tele-diabetological ESYSTA®product system, it automatically saves
all of the insulin quantities injected, along with the associated time.
This data is transferred in encrypted form via Bluetooth®radio technology1to
your ESYSTA®App. The ESYSTA®App can be found in the corresponding App
portals. The transfer of data to the ESYSTA®Portal is also supported.
With the ESYSTA®BT Pen, you can use all common insulin cartridges from
various manufacturers. So you can continue to use the insulin preparation you
have previously been prescribed.
To integrate other devices that we supply into the innovative ESYSTA®product
system, visit our website:
www.emperra.com
Thank you for trusting our ESYSTA®devices. As you will see, the ESYSTA®
BT Pen will make your treatment easier.
1
The Bluetooth word mark and logo are the property of Bluetooth SIG, Inc. These brands are used by Emperra under licence.
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2. Correct use
2.1 ESYSTA®BT Pen
The ESYSTA®BT Pen is a medical product. For the treatment of
diabetes mellitus by trained patients or trained carers, it is used to manually
inject insulin preparations from 3 ml insulin cartridges2(100 IU/ml). Up to 60
IUs can be injected through human strength. You can set your insulin dose in
whole units. An ESYSTA®BT Pen is only intended for treating one patient.
2.2 ESYSTA®Adapter (disposable adapter)
The ESYSTA®Adapter is an accessory (a consumable) required for operating
the ESYSTA® BT Pen, in order to be able to use insulins from dierent
manufacturers. There are three dierent designs.
The ESYSTA®Adapter is a disposable item. A new ESYSTA®Adapter
must be used with each new insulin cartridge. Information on selecting
the right ESYSTA®Adapters for your insulin preparation can be found in
Chapter 7.
2Also referred to as a cartridge or ampoule.
1The Bluetooth word mark and logo are the property of Bluetooth SIG, Inc. These brands are used by Emperra under licence.
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2.3 Data transfer
The ESYSTA®BT Pen can transfer the injected quantities of insulin together
with the date and time of the injection to the ESYSTA®App via a conventional
smartphone using Bluetooth®radio technology.
You also have the option of registering with the ESYSTA®Portal at
www.esysta.com. On the Portal, you can allow your doctor to view your
treatment data. For optimal use of the system, we recommend that you agree
your treatment with your doctor or practice.
2.4 Information for doctors and medical sta
The operation of the ESYSTA® BT Pens does not essentially dier from that of
other insulin pens. There are additional functions and operating steps. If you
instruct patients in the use of the ESYSTA®BT Pen, or use it on patients, you
should be comprehensively familiarised in advance with both the operation
and these operating instructions in order to avoid making errors in use. Should
you have any questions, please contact us (see p. 56).
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3. Information on safe use
Before using the ESYSTA®BT Pen, you must always receive training
from your doctor, pharmacist or diabetes adviser.
Before using your ESYSTA®BT Pen, please read all of these operating
instructions carefully and follow the instructions exactly. Not following
the instructions may lead to injecting a dose of insulin that is too high or too
low.
If you need help, please contact your doctor, pharmacist, diabetes
adviser or Emperra GmbH.
Before each use, check your ESYSTA®BT Pen for damage. In the case
of damage such as cracks or breaks, or if the display or parts of the
display are not functioning, do not use the ESYSTA®BT Pen.
Always handle your ESYSTA®BT Pen with care. Strong vibrations
may damage the device. The ESYSTA®BT Pen must not be used
improperly or opened using force, as this will damage the device and the
guarantee will be rendered invalid.
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Always set the number of units correctly. The dose is increased by exactly
one unit for each click when the dosing button is turned clockwise. The
dose is increased by exactly one unit for each click when the dosing button is
turned anti-clockwise. Do not use the ESYSTA® BT Pen if the units displayed dier
from the number of units identied through the clicking and locking mechanism.
In this case, contact Emperra GmbH, your doctor, pharmacist or diabetes
adviser.
Also do not use the ESYSTA®BT Pen if you cannot see anything on the
display or if the display appears faulty.
You must be able to clearly feel and hear the "click" when setting the
dose in order to use the ESYSTA®BT Pen.
Always be prepared in case of loss or damage to your ESYSTA®BT
Pen. We recommend always keeping an additional insulin-injecting
device to hand for the relevant insulin.
The ESYSTA®BT Pen is not licensed for use by blind or visually-
impaired people. You must be able to clearly recognise the display as
well as dierent marker colours.
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