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Address of the manufacturer:

Emperra GmbH

E-Health Technologies

Friedrich-Ebert-Strasse 33

D-14469 Potsdam

Germany

Telephone: +49(0)331 / 9793480 - 0

Fax:

+49(0)331 / 9793480 - 19

E-Mail: [email protected]

Web: www.emperra.com

H49 (0)800/3673772 (0800 EMPERRA)

Mon. - Fri. 8.30 a.m. - 5 p.m.

(free of charge from German landlines)

0482

FCC Certification

FCC ID: 2AHMS-BTPEN1

This device complies with part 15 of FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation.

Содержание BT Pen

Страница 1: ...Operating instructions ESYSTA BT Pen...

Страница 2: ...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...

Страница 3: ...dentification l Case l Operating 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 o...

Страница 4: ...oning 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...

Страница 5: ...tery 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...

Страница 6: ...he 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 preparatio...

Страница 7: ...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 a...

Страница 8: ...mal use of the system we recommend that you agree your treatment with your doctor or practice 2 4 Information for doctors and medical staff The operation of the ESYSTA BT Pens does not essentially dif...

Страница 9: ...in 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...

Страница 10: ...rra 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 he...

Страница 11: ...afe 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...

Страница 12: ...e needles and the insulin contained within them l Too much or too little insulin can be injected through incorrect operation Under dosing through too little insulin being injected will lead to hypergl...

Страница 13: ...ts 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 a...

Страница 14: ...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 off Display...

Страница 15: ...SYSTA 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 Gmb...

Страница 16: ...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...

Страница 17: ...erlin Chemie B Braun and Sanofi 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...

Страница 18: ...ly selected ESYSTA Adapter into the pen body with the threaded rod at the front Then slide the insulin cartridge with the stamp at the front into the ESYSTA Adapter The needle side of the insulin cart...

Страница 19: ...A BT Pens containing different insulins identify these ESYSTA BT Pens by using the coloured markers provided The markers are inserted into the recess on the pen body It is important that you can recog...

Страница 20: ...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...

Страница 21: ...the insulin cartridge cap and that the insulin can thus flow freely through the needle You can first remove the outer and then if present the inner protective cap on the needle Note Regarding the han...

Страница 22: ...dicates how many hours have passed since the last injection of insulin and how many units you injected On the left are displayed the time smaller figures with the unit H for hours and on the right the...

Страница 23: ...l it locks into place The display now goes out and the units set are saved as venting units If no insulin visibly emerges from the tip of the needle after this venting procedure irrespective of the in...

Страница 24: ...the tip of the needle All units are marked and saved as venting units Unlocking the dosing button again prepares the ESYSTA BT Pen for a subcutaneous dosage of insulin as described below 6 9 Setting t...

Страница 25: ...ulin will always remain in the cartridge If the insulin cartridge contains less insulin than the required dose you will only be able to inject an incomplete dose Once you switch on your ESYSTA BT Pen...

Страница 26: ...en you next switch on the ESYSTA BT Pen will 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...

Страница 27: ...hy Please press slowly until the dosing button locks into place You should also systematically change your injection sites The dosing button is equipped with a strong spring to guarantee complete and...

Страница 28: ...he current blood sugar value so that you can be sure that you are not injecting too much insulin and thereby triggering a dangerous state of hypoglycaemia 6 11 Completing the injection Once you have i...

Страница 29: ...osing button Please proceed as in Chapter 6 11 Note Do not turn the dosing button of the ESYSTA BT Pen into the negative range This may happen by turning the dosing button beyond zero against the dire...

Страница 30: ...therefore recommend switching to a new insulin cartridge that has been stored in the temperature range specified by the insulin manufacturer An injection can still be carried out by adjusting the sel...

Страница 31: ...r 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 c...

Страница 32: ...necessary in the ESYSTA Portal 7 3 Important safety information about changing the cartridge After changing the insulin cartridge you must carry out a venting procedure You may frequently have to carr...

Страница 33: ...Dispose of old batteries correctly never in your domestic waste Battery collection points can be found in all shops that sell batteries Only open the battery compartment to change the batteries as ot...

Страница 34: ...point upwards Incorrectly inserted batteries may damage the device Once all three batteries are correctly inserted push the battery compartment back in completely Then check the function of the ESYST...

Страница 35: ...after the arrows 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...

Страница 36: ...nction again and repeat steps 1 to 4 for each individual Pen Note Ideally you should always keep transfer mode active so that your current treatment data is always available in the ESYSTA App The ESYS...

Страница 37: ...y code displayed To cancel bonding carry out the following steps on the Pen 1 Push the dosing button out 2 Turn the button for 2 units and then back to 0 units 3 Push the button in 4 The display now s...

Страница 38: ...memory awaiting transmission There are over one hundred data records in the memory that have not yet been transferred There is still sufficient free memory available There is a high number of records...

Страница 39: ...prevent errors when reading due to partial failure of the display Thirty units were injected around 1 hour ago Currently 17 insulin units are set Counts every second from 8 to 1 Leave the needle in t...

Страница 40: ...figure appears The pen is intended for injecting up to 60 units of insulin Turn the dosing button against the direction of the arrow until a number appears again The last injection was more than 99 ho...

Страница 41: ...se contact Emperra GmbH For the next injection the actual dose injected may be lower than the dose displayed This is why your ESYSTA BT Pen must be vented before the next injection until insulin visib...

Страница 42: ...ll continue to exist Please transfer the data see Chapter 9 This display urges you to vent the pen It is triggered by various conditions and guarantees safe function of the pen Make sure that the vent...

Страница 43: ...damaged in this way are excluded from the right to exchange Display Explanation See Chapter 9 The three indicators appear on the display in sequence Together they create the 6 digit security code whi...

Страница 44: ...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 After 24 months of use the...

Страница 45: ...Ah Height 2 5 mm 0 2 mm Diameter 12 5 mm 0 3 mm Once the insulin cartridge is inserted please follow the prescribed storage temperature of your insulin preparation instructions enclosed by the insulin...

Страница 46: ...ng the dosing button when pushed in unlocking the cartridge holder such as when changing the insulin cartridge changing the battery turning the unlocked dosing button to 1 and back to 0 see also Chapt...

Страница 47: ...s blocked replace it with a new needle in its original packaging The ESYSTA BT Pen may possibly be insufficiently vented see Chapters 6 7 and or 6 8 Question Why do I have to use a new ESYSTA Adapter...

Страница 48: ...ay Should data continue not to be sent please contact Emperra GmbH Question Why does the ESYSTA BT Pen go out immediately after injecting Answer The ESYSTA BT Pen may have been in venting mode see Cha...

Страница 49: ...have switched on the ESYSTA BT Pen according to these operating instructions and there is nothing on the display please change the batteries If this does not help then you should always keep a replace...

Страница 50: ...e Protaphane Penfill 100 IU ml injection suspension in a cartridge Sanofi Aventis Lantus 100 IU ml injection solution in a cartridge Apidra 100 IU ml injection solution in a cartridge Insuman Rapid 10...

Страница 51: ...ml injection solution in cartridge pen Berlin Chemie Berlinsulin H Normal 3 ml pen injection solution Berlinsulin H 30 70 3 ml pen injection suspension Berlinsulin H Basal 3 ml pen injection suspensi...

Страница 52: ...dles e g 8 or 10 mm If your product is not listed in the table below please contact Emperra GmbH Manufacturer BECTON DICKINSON GMBH BERLIN CHEMIE AG YPSOMED GMBH BERENBRINKER SERV GMBH NOVO NORDISK PH...

Страница 53: ...38 Display 22 39 43 Dosing button 10 14 21 29 Dosing 24 26 Venting 23 Disposal 28 33 Error messages 39 43 Questions 46 49 Function test 22 Guarantee 43 Holder 17 Injection 26 29 Insulin 31 32 50 51 N...

Страница 54: ...54...

Страница 55: ...55...

Страница 56: ...com Hotline 49 0 800 3673772 0800 EMPERRA Mon Fri 8 30 a m 5 p m free of charge from German landlines 0482 FCC Certification FCC ID 2AHMS BTPEN1 This device complies with part 15 of FCC Rules Operati...

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