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ESYSTA BT Pen Operating Instructions Manual

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Operating instructions
ESYSTA
BT Pen
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Summary of Contents for ESYSTA BT Pen

  • Page 1 Operating instructions ESYSTA BT Pen ®...
  • Page 2 Pen body Adapter Insulin cartridge Holder Threaded rod Cartridge stamp Needle side of the cartridge ESYSTA BT Pen, example with adapter B and holder A/B ®...
  • Page 3 Markers for colour identification Case Operating instructions 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...

  • Page 4: Table Of Contents

    Marker Attaching the needle Switching on the ESYSTA BT Pen ® ESYSTA BT Pen pre-set venting ® Marking and carrying out additional venting Setting the units for subcutaneous injections 6.10 Injection procedure 6.11 Completing the injection process 6.12 Cancelling the setting process...
  • Page 5 Changing the insulin cartridge Continuing with the same insulin manufacturer Changing the insulin manufacturer Important safety information about changing the cartridge Changing the battery Enabling and disabling data transfer Enabling the Pen-smartphone connection (“bonding”) Disabling the Pen-smartphone connection (cancelling "bonding”) Data memory Display and error messages Guarantee...

  • Page 6: Introduction

    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 technology ®...

  • Page 7: Correct Use

    The ESYSTA Adapter is an accessory (a consumable) required for operating ® the ESYSTA BT Pen, in order to be able to use insulins from different ® manufacturers. There are three different designs. The ESYSTA Adapter is a disposable item. A new ESYSTA Adapter ®...

  • Page 8: Data Transfer

    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.

  • Page 9: Information On Safe Use

    ® 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.
  • Page 10 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 ® Pen. We recommend always keeping an additional insulin-injecting device to hand for the relevant insulin.
  • Page 11 In the case of impairment that prevent the safe use of the ESYSTA ® 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.

  • Page 12: Risks Associated With Its Use

    Over-dosing by injecting too much insulin causes hypoglycaemia (low blood sugar), which can quickly become a critical condition. In order to prevent incorrect doses, the ESYSTA BT Pen must be sufficiently ® vented before each use and particularly after each change of cartridge; see...

  • Page 13: General Information

    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.

  • Page 14: Components Of Your Esysta

    5. Components of your ESYSTA BT Pen ® Display Dosing button pressed in Battery compartment ("Pen switched off") with serial number Holder Markers Unlocking the dosing button ("Pen switched on")

  • Page 15: Commissioning Your Esysta Bt Pen

    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 different colours should help you to distinguish your different insulins, even in the ESYSTA App.

  • Page 16: Adapter

    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.

  • Page 17: Choosing The Holder

    6.2 Choosing the correct holder Your ESYSTA BT Pen is delivered with two different holders. ® Holder Type A/B is for use with insulin cartridges made by the manufacturers Lilly , Berlin-Chemie , B.Braun and Sanofi-Aventis . In addition to being ®...

  • Page 18: Inserting The Insulin Cartridge

    Then slide the insulin cartridge with the stamp at the front into the ESYSTA Adapter. The needle side of the insulin ® cartridge now protrudes out of the open side of the ESYSTA Adapter. ® Then slide the holder over the ESYSTA Adapter filled with the insulin cartridge ®...

  • Page 19: Marker

    If you regularly use more than one insulin preparation, we recommend that you use an additional ESYSTA BT Pens for each additional insulin preparation. In ® order to be able to distinguish ESYSTA BT Pens containing different insulins, ® identify these ESYSTA BT Pens by using the coloured markers provided.
  • Page 20 Note: Every time before you use your ESYSTA BT Pen, please check the inserted ® insulin cartridge to ensure that you are using the correct insulin preparation type. Do not rely solely on the marker!

  • Page 21: Attaching The Needle

    ® BT Pen To switch on ESYSTA BT Pen, press on the dosing button as you would a ® ball-point pen, so that the dosing button pops out. If the dosing button is to be unlocked when the display is switched off ("stand-by mode"...
  • Page 22 Once the ESYSTA BT Pen is switched on, a display test initially appears. ® The following display appears: This display test is for your security. Check whether all of the segments to be displayed here are present. If individual segments of the...

  • Page 23: Bt Pen

    Portal, unlock the dosing button again so that the ® ESYSTA BT Pen is switched on (see Chapter 5). Now set one ratchet ® position (1 IU) by turning the dosing button in the direction of the arrow - without pushing the dosing button in - and then turn it against the direction...

  • Page 24: Setting The Units For Subcutaneous Injections

    6.9 Setting the units for subcutaneous injections Once the ESYSTA BT Pen is sufficiently vented and you have switched it on ® by unlocking the dosing button (see Chapter 5), you can now set the insulin units.
  • Page 25 Note: Only use the ESYSTA BT Pen for injection if you receive the following ® responses: l Display of the set units l Audible click for each unit set l Ratcheting action felt for each unit set If you inadvertently set too high a dose, you can correct (reduce) this by turning the dosing button against the direction of the arrow.

  • Page 26: Injection Procedure

    ® request venting (see also Chapter 6.7). To preserve the life of the battery for as long as possible, you should always store your ESYSTA BT Pen with the dosing button pushed in and ® the ESYSTA Adapter inserted. ®...
  • Page 27 Note: The ESYSTA BT Pen is equipped with a mechanism that guarantees that the ® insulin emerges evenly during the injection procedure. However, pushing the dosing button too fast may lead to the insulin being injected too quickly. This may lead to an alteration in the cells (hardening or lumps in the fatty tissue, also called lipodystrophy or lipohypertrophy).

  • Page 28: Completing The Injection Process

    To avoid the risk of painful infections, use each needle only once. After each injection of insulin, put the cap on the ESYSTA BT Pen and store it in the case provided, in order ® to prevent damage and contamination.

  • Page 29: Cancelling The Setting Process

    Even if you have already set the units, you can cancel this setting procedure without wasting insulin. Reset the ESYSTA BT Pen back to zero by turning the ® dosing button against the direction of the arrow and then pushing in the dosing button.

  • Page 30: Temperature Sensor

    6.13 Temperature sensor The ESYSTA BT Pen is equipped with a temperature sensor that regularly ® measures the ambient temperature and indicates the results on the display. Extreme ambient temperatures can reduce the effectiveness of the insulin or even render it ineffective.

  • Page 31: Changing The Insulin Cartridge

    Insulin cartridges are changed and inserted with the dosing button unlocked (see Chapter 5). Please also always note the relevant designation of the insulin ® type in the ESYSTA App. You may need to modify it if necessary. 7.1 Continuing with the same insulin manufacturer First, pull off the cap.

  • Page 32: Changing The Insulin Manufacturer

    You must use a new suitable ESYSTA Adapter with each new insulin ® cartridge! Even if your last insulin cartridge was not completely emptied, because your doctor changed your treatment, for example, a new ESYSTA ® Adapter must also be used with the new insulin cartridge.
  • Page 33 ESYSTA BT Pen. If the battery voltage is low, then "bL" (battery low) will be ® displayed when you switch on the ESYSTA BT Pen.
  • Page 34 Then check the function of the ESYSTA BT Pen by venting as described in ® Chapter 6.7. Note: We advise changing the batteries near your smartphone with the ESYSTA ® App and with Bluetooth transfer switched on and then importing the data, ®...

  • Page 35: Enabling And Disabling Data Transfer

    “Next” confirms your entries and takes you to the next menu item. 2. Put the ESYSTA BT Pen in transfer mode by following the instructions on ® the smartphone display. “Next” takes you to the next menu item after each command.
  • Page 36 ® ® can only exchange data with a smartphone. Any attempt to connect to other devices will not work. Even if you are using the ESYSTA App on a second ® smartphone and search for the Pen, you will not find it there. If however you want or have to do this anyway, for example because you have a new phone, then you must cancel the connection (“bonding”) between the previous...

  • Page 37: Disabling The Pen-Smartphone Connection (Cancelling "Bonding")

    9.2 Disabling the Pen-smartphone connection (cancelling "bonding”) If you want to cancel the connection between the previous smartphone and the ESYSTA BT Pen (“bonding”), for example because you have changed your ® smartphone, carry out the following steps on the ESYSTA BT Pen.

  • Page 38: Data Memory

    There is a high number of records in the memory that have not yet been transferred. The memory is full. The oldest data will be overwritten by current data. Note: ® The insulin application function of the ESYSTA BT Pen will not be affected by a full memory.

  • Page 39: Display And Error Messages

    Administration of Seventeen units have just been injected. insulin complete Wireless mode The ESYSTA ® BT Pen is searching for contact with flashing the smartphone. Once contact is made, it sends the saved data. Radio mode The ESYSTA ®...
  • Page 40 Designation Explanation Display Negative Caution, serious error! Turn the dosing button units set clockwise until zero or a higher figure appears. More than The pen is intended for injecting up to 60 units of 60 units set insulin. Turn the dosing button against the direction of the arrow until a number appears again.
  • Page 41 This is why your with the dose set in the ESYSTA ® BT Pen must be vented before the next negative range injection until insulin visibly emerges from the nee- dle. The dosing button was not pushed in all the way...
  • Page 42 Meaning This message is displayed during switch-on after 24 The ESYSTA BT Pen ® months of use. Discontinue the use of the ESYSTA ® has reached the end of BT Pen from this point in time. its useful life This message will be displayed on every operation The end of the life of during the last two weeks of the period of use.

  • Page 43: Guarantee

    BT Pen with a smartphone. (As an example here: 123456) 11. Guarantee Emperra GmbH accepts liability problems with ESYSTA BT Pen resulting from improper handling of the device. ® Devices damaged in this way are excluded from the right to exchange.

  • Page 44: Period Of Use

    12. Period of use Your ESYSTA BT Pen is designed for a period of use of up to two years from ® the date of initial use. In the six weeks before expiry of the period of use, the adjacent display will appear on each operation. Please remember to get a new ESYSTA BT Pen in good time.

  • Page 45: Technical Data

    13. Technical data Insulin pen Dimensions (with dosing button pushed in): approx. 180 mm x 23 mm x 25 mm Weight without insulin cartridge: 62 g Battery Power supply: 3 x button cells, CR 1225 Nominal voltage: 3.0 V Nominal capacity: 50 mAh Height: 2.5 mm ±...

  • Page 46: Faqs

    Various manufacturers use insulin cartridges with different dimensions, and you will have to select the right ESYSTA Adapter for this. ® You will find a table in Chapter 6.1 and on the packaging of the ESYSTA BT Pen ® and ESYSTA adapters.
  • Page 47 Various manufacturers use insulin cartridges with different dimensions, and you will have to select the right ESYSTA Adapter for ® this. There is a table in Chapter 6.1 and on the packaging of the ESYSTA BT Pen ® and the ESYSTA Adapters.
  • Page 48 To transfer data, insulin injections must have been already stored in the ESYSTA ® BT Pen. You can identify this in the upper section of the display. Should data continue not to be sent, please contact Emperra GmbH. Question: Why does the ESYSTA BT Pen go out immediately after injecting? ®...
  • Page 49 Answer: There may be various reasons for this. Data transfer on your smartphone is disabled. You are in an area with inadequate GSM network coverage. Question: What should I do if I can't switch on the ESYSTA BT Pen? ®...

  • Page 50: List Of Compatible Insulin Preparations

    15. List of compatible insulin preparations Novo Nordisk ® NovoRapid Penfill 100 IU/ml injection solution in a cartridge ® ® NovoMix 30 Penfill 100 IU/ml injection suspension in a cartridge ® ® Levemir Penfill 100 IU/ml injection solution in a cartridge ®...
  • Page 51 Lilly ® Huminsulin Normal 100/ for pen 3 ml/pen injection solution ® Huminsulin Profil III for pen 3 ml/-pen injection suspension ® Huminsulin Basal (NPH) 100/-for pen 3 ml/-pen injection suspension ® Humalog 100 IU/ml injection solution/pen 100 IU/ml ® Humalog Mix 25 100 IU/ml injection suspension/-Pen ®...

  • Page 52: List Of Compatible Needles

    All needles in the list below are available in various lengths. Compatibility with the ESYSTA BT Pen depends on the length of the needles (e.g. 8 or 10 mm). ® If your product is not listed in the table below, please contact Emperra GmbH.

  • Page 53: Index

    17. Index Page Adapter 7, 16, 32 6, 30, 35-37 Battery 33-34 Bonding 35-37 Transferring data 35-38 Display 22, 39, 43 Dosing button 10, 14, 21-29 Dosing 24-26 Venting Disposal 28, 33 Error messages 39-43 Questions 46-49 Function test Guarantee Holder Injection 26-29...
  • Page 56 Friedrich-Ebert-Strasse 33 D-14469 Potsdam Germany Telephone: +49(0)331 / 9793480 - 0 Hotline +49 (0)800/3673772 (0800 EMPERRA) Fax: +49(0)331 / 9793480 - 19 Mon. - Fri. 8.30 a.m. - 5 p.m. (free of charge from German landlines) E-Mail: esysta@emperra.com 0482 Web: www.emperra.com...

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