ESYSTA BT Pen Operating Instructions Manual
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
4
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
5
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
6
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 technology1 to
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.
7
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.
2
Also referred to as a cartridge or ampoule.
8
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).
9
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.
10
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.
11
In the case of impairment that prevent the safe use of the ESYSTA® BT
Pens, a trained assistant should be consulted.
Observe the temperatures for storage and use. For example, please
consider the fact that temperatures of over 70° C may occur in cars in
the summer. Please also note Chapter 6.13 (Temperature sensor).
Protect your ESYSTA® BT Pen against dirt, moisture and the penetration
of other foreign matter. Only transport and store your ESYSTA® BT Pen
with the cap on, and keep it in a safe place where it cannot be confused with
other things.
On the ESYSTA® Adapter is a scale intended for use in estimating the
amount of insulin remaining in the cartridge. This scale must not be
used for measuring the dose of insulin.
Keep your ESYSTA® BT Pen, your insulin cartridges and injection
needles out of reach of unauthorised persons - and children in particular.
There are magnets in your ESYSTA® BT Pen. If you have a heart
pacemaker, please consult your cardiologist to have conrmed in writing
that it is safe for you to use the ESYSTA® BT Pen before using the ESYSTA®
BT Pen.
There are magnets in your ESYSTA® BT Pen. It should not be stored
together with magnetic cards, for example.
12
3.1 Risks associated with use
Find out about the risks and side eects of your insulin preparation.
In spite of all of the safety precautions, there are residual risks from the use of
the ESYSTA® BT Pen.
lInfections may occur if the injection needles are used more than once.
lUnprotected injection needles can cause injuries and transmit
diseases. Third parties - particularly children - can be injured or
even killed by the needles and the insulin contained within them.
.
lToo much or too little insulin can be injected through incorrect operation.
Under-dosing through too little insulin being injected will lead to
hyperglycaemia (high blood sugar), which may nally render the patient
unconscious and is often associated with complications. Over-dosing by
injecting too much insulin causes hypoglycaemia (low blood sugar), which
can quickly become a critical condition.
lIn order to prevent incorrect doses, the ESYSTA® BT Pen must be suciently
vented before each use and particularly after each change of cartridge; see
also Chapters 6.7 and 6.8.
13
4. General information
The CE mark on a medical device states that the product meets the provisions
of the EU Directive on Medical Products 93/42/EEC. The ESYSTA® BT Pen
insulin injection device meets the requirements of dosing accuracy under ISO
11608-1: Pen injectors for medical use – Part 1: Pen injectors – Requirements
and test procedures. As part of the tele-medical ESYSTA® product system, the
ESYSTA® BT Pen is equipped with a wireless interface for data. The ESYSTA®
BT Pen meets the fundamental requirements of Directive 1999/5/EC for wireless
installations and telecommunication transmission facilities.
The ESYSTA® BT Pen has been tested for electromagnetic compatibility in
accordance with EN 60601-1-2 Medical electrical equipment Part 1-2: General
requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests.
You can set your insulin dose in whole units. The ESYSTA® BT Pen has a
memory that saves all your doses, along with the date and time. The memory
capacity is approx. 1,000 data records.
In combination with the ESYSTA
®
App, the data is transferred to a Bluetooth®-
enabled smartphone.
14
5. Components of your ESYSTA® BT Pen
Battery compartment
with serial number
Cap
Holder Markers
Cap Unlocking the dosing button
("Pen switched on")
Dosing button pressed in
("Pen switched o")
Display
15
6. Commissioning your ESYSTA
®
Pen
Before rst use, carefully pull out the lm of the battery compartment that is
visible from the outside.
Your ESYSTA® BT Pen must be equipped with an insulin cartridge, a matching
adapter, the appropriate holder and a needle. Please mark all of your ESYSTA®
BT Pens with a coloured marker. The dierent colours should help you to
distinguish your dierent insulins, even in the ESYSTA® App.
Note:
Only use the ESYSTA® BT Pen with the insulin cartridges stated by Emperra
GmbH and make sure that you use the correct ESYSTA® Adapter. If your
insulin preparation is not stated in Chapter 15, please contact Emperra GmbH
directly. Contact details can be found at the end of these operating instructions.
Note:
Before each injection of insulin, please check that the holder is straight and
securely locked into the retainer. Otherwise there is a risk of incorrect dosage.
If an insulin cartridge leaks and liquid enters the device, the ESYSTA® BT Pen
may no longer be used.
The button is spring loaded. Please keep away from delicate areas of
the body, such as the eyes!
16
6.1 Selecting the right ESYSTA® Adapters
Depending on the manufacturer, insulins are available in cartridges of various
sizes. Your ESYSTA® BT Pen can be used with all of the 3 ml cartridges (100
IU/ml) named in Chapter 15, if you use the appropriate ESYSTA® Adapter.
Select it from the table below.
In order to always guarantee optimal dosing accuracy, the ESYSTA® Adapters
are designed to be disposable products. Always change the ESYSTA® Adapter
every time you change the insulin cartridge.
Tampering with the ESYSTA® Adapter may have fatal consequences and
is strictly forbidden!
Suitable for 3 ml insulin cartridges
(100 IU/ml) from
Lilly®, Berlin-Chemie
®
and B.Braun
®
Sano-Aventis
®
Novo Nordisk
®
Cartridge adapter type
and colour
A
B
C
Holder
Holder A/B
BU
Holder A/B
Holder C
17
6.2 Choosing the correct holder
Your ESYSTA® BT Pen is delivered with two dierent holders.
Holder Type A/B is for use with insulin cartridges made by the manufacturers
Lilly®, Berlin-Chemie®, B.Braun® and Sano-Aventis®. In addition to being
labelled "A/B", this holder can be distinguished by its screw thread.
Holder Type C is for use with insulin cartridges made by Novo Nordisk®. In
addition to being labelled "C", you can recognise this holder by its lack of a
screw thread, as the insulin cartridges of Novo Nordisk® have their own screw
thread.
Holder A/B Holder C
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