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H-TRONplus - ACCU-CHEK Insulin Pumps

1. If the pump alarms ERROR 07 remove the battery and go to step 7 6 gt Insert a NEW battery in compartment 2 motor Set the clock review the basal rates change the pump to RUN If the pump alarms ERROR 07 remove both batteries and go to step 7 7 gt Change to your back up insulin delivery device or contact your health care team for an alternate insulin therapy plan Call Disetronic at 1 800 688 4578 Note When both batteries have been removed and then reinserted the insulin re maining counter is reset to 315 0 units as if a full cartridge is being used If however the cartridge is not full the insulin remaining counter will not reflect the actual amount being used in the cartridge In this case you must be ready to change the cartridge at or before the usual time Also note that the data memory is reset when the batteries are reinserted or replaced simultaneously For more information see section 3 2 2 remove both batteries 7 8 Alarm ERROR 8x Technical Inspection Alert X stands for the number of weeks until technical inspection is due The number varies as outlined below Technical Inspection is required after the first 24 months of pump use The pump alerts you when it nears the time for the technical inspection to allow you to schedule the inspection and to change to your back up insulin delivery device The pump alarms eight six four and two weeks before technical inspection is due to
2. 606 ia Three short beeps long beep Change to STOP No insulin administration E Continous beeping ERROR Read and understand section 7 Alarms Activating the display In order to save power the display LCD Liquid Crystal Display goes blank after 30 seconds if no buttons are pressed It remains blank until buttons are pressed To view the display again press the h and m buttons at the same time for one second Any other button can also be pressed but then not only is the display illuminated but the function related to this button will also be displayed Caution Never press any button with a sharp item or your fingernails Use the pad of your finger instead to pre h ny h m vent puncturing the buttons 1 4 H TRONplus Reference Manual S button The S button the select button is for choosing the functions of the E pump A cursor represented as a small triangle lt a or gt moves with each press of the S button and indicates the currently selected func tion h button m button ko Pressing one of these rubber type buttons will activate the selected function To set a value press the h button to increase the value 4 or m button to decrease the value Some of the functions are activated by simultaneous pressing of the h and m buttons Other functions start automatically after a defined period and a confirmation by a beep Scrolling function Availabl
3. gt Be sure that the pump adapter is tight Be sure the infusion set luer lock connection is tight but do not over tighten Over tighten ing may crack the luer lock cartridge compartment i gt 29 gt Screw the pump adapter clockwise into the cartridge compart gt y 30 4 2 Half fill the plastic cartridge Special conditions may require that you half fill the plastic cartridge Note Do not half fill glass cartridges Plastic cartridges have a scale which allow you to half fill these cartridges Plastic cartridges are half filled when the top of the plunger is half way between the 1 4 ml and 1 6 ml marker lines Caution In order to use half filled plastic cartridges you need to follow a specific procedure to re set a new half filled cartridge Please refer to section 4 4 2 of this reference manual To half fill a plastic cartridge follow steps one to 30 in section 4 1 fill the cartridge However make sure that you follow steps 6 and 13 as slightly modified below 38 H TRONplus Reference Manual E Step 6 gt Move the plunger back and forth in the cartridge two times to distribute the lubricant Pull the plunger back so that the top of the Has plunger is between the 1 4 and 1 6 ml marker lines Step 13 gt The cartridge is half full when the top of the plunger is half way between the 1 4 ml and 1 6 ml marker lines Sha bs 4 3 Fill the cartridge using the EasyFill The EasyFill is an opti
4. occlu sion ERROR 04 may be delayed Remove these bubbles according to the instructions while filling the cartridge Cold insulin may release dissolved air when warmed Use only insulin at room or preferably body temperature when filling the cartridge 34 H TRONplus Reference Manual n jo A cartridge set consists of 1 Cartridge 3 15 ml plastic or glass 2 Cartridge protective cap 3 Cartridge plunger 4 Plunger rod 5 Filling needle with 6 Protective cover 7 Filling aid EasyFill optional The H TRONplus Insulin Pump functions with 3 15ml plastic or glass AQ cartridges The following example shows how to fill a cartridge Always SS consult the instructions for use included with your cartridge sets 4 1 1 Prepare the cartridge Steps 1 to 7 1 gt Get everything ready ES New cartridge and plunger rod T New cartridge protective cap New filling needle with protective cover ee Insulin at room temperature to minimize formation of air bubbles 2 gt Wash your hands e 3 gt Remove the cartridge with plunger rod and protective cap from A blister pack 2 4 gt Remove filling needle with protective cover from blister pack Be careful not to touch the open end of the filling needle or cartridge U 50 tip as they are sterile 5 gt Place filling needle with cover on cartridge tip and tighten j Tighten it by pressing and turning at the same t
5. mation by your doctor or health care provider For the possible ranges see section 2 4 programmable settings 7 6 Alarm ERROR 06 Automatic Off This safety feature alarms if a button has not been pressed within a set amount of time It can remind you to check the pump regularly This alarm is not activated by Disetronic unless ordered by your health care team When this safety feature is activated and if no button h m or S is pressed within the programmed time limit 1 24 hours the pump will display an alarm ERROR 06 change to STOP and beep continuously Do the following Silence alarm by holding S for three seconds ERROR 06 stays on the display Change the pump to RUN Contact your health care team about the need to possibly re evaluate the automatic off limit if necessary The automatic OFF can be modified by Disetronic upon written confirmation by your doctor or health care provider For the possible ranges see section 2 4 programmable settings 66 H TRONplus Reference Manual 7 7 Alarm ERROR 07 System Alarm The alarm ERROR 07 cannot be silenced by pushing a button Remove BOTH batteries at the same time to silence alarm ERROR 07 Caution If both batteries are removed and then reinserted or replaced Data Memory is cleared The pump is reset to a full cartridge volume and displays 315 0 units The clock is reset to 00 00 hours For more information see
6. 1 eens 52 10 2 5 Cartridge and infusion set 0 cece ee eee ees 85 6 2 1 Set temporary basal rate increase 0c eee eee 52 10 3 St r the PUMP si skein ee Chee Aw Caw Be alg ean eae 85 6 2 2 Set temporary basal rate decrease 00 eee eee 53 10 4 Battery information fi Axia end awed awe wesw 85 6 3 Control the beeps 5 ncaa saves scissors uistinu ECNE DEDEN 55 10 5 YOUN pump checklist siess aaa aia aa ead a i a 87 6 4 Control the STOP Alarm sisi sete sein anana 56 10 6 Package and return the pump 00 cece cence neers 88 6 5 Basal rate lock unlock sinc do ck ted edn he deans stdagln eaewes 57 11 Technical data 89 7 Alarms ERROR 58 11 1 Technical data 0 cee eens 89 7 1 Alarm ERROR 01 Empty Cartridge 0 cece eee eens 60 112 list Of symbols gee cue es that reac iara nade btaddascas tes 90 7 2 Alarm ERROR 02 Low Motor Battery 2 0 cece eeeee 60 12 Glossary 92 7 3 Alarm ERROR 03 Low Electronic Battery 3 0 00 00s 61 13 Index 95 7 4 Alarm ERROR 04 Occlusion occu cuca cd rdeaseandewann ge neumhs 62 7 5 Alarm ERROR 05 Bolus Limit Reached 000 00 eee 65 7 6 Alarm ERROR 06 Automatic Off 0c eee eee 66 4 H TRONplus Reference Manual H TRONplus Reference Manual 5 Introduction safe and efficient use of the H TRONplus Insulin Pump User manual Read this manual carefully before using the H TRONplus Insulin Pump Alway
7. 48 In the cartridge 36 40 In the infusion set 42 Alarm ERROR 13 58 Recall alarm messages 51 Control the STOP Alarm 56 Automatic off 66 Airport security 10 B Basal rates 17 89 92 Change enit nna 31 Lock unlock 57 Program 004 28 RevieW 0e cece eee 32 Temporary increase 17 52 92 Temporary decrease 17 53 92 Total 000 29 92 Batteries 11 18 22 85 89 Change ccssessaece sees 25 Insert aroraa eee 24 Insert both batteries 25 Remove both batteries 22 26 49 storage eee eee 86 Alarm ERROR 02 Low Motor Battery inre pona aana amis 60 Alarm ERROR 03 Low Electronic Battery 0 8 61 Batter tool civil dave de es dens 19 BEEPS asec cereals ee oe 13 Control the beeps 12 55 Blood glucose 8 75 BolUlSs cece eee eee 17 Cancel 2 2 0 0 eee 47 LAME E E T 65 Program 2 005 46 Recall recent boluses 50 Buttons S h and m 15 C Cancelabolus 00 47 Camndge sis cei cane was 19 85 92 Change a cartridge and an infusion set 47 Fill the cartridge 34 Fill the cartridge using EasyFill 39 Half fill the plastic cartridge 38 81 Reset new cartridge 41 Reset new half full cartridge 41 81 Alarm ERROR 01 Empty Ca
8. Dimensions I x d xh Weight Case Temperature ranges Air humidity Barometric pressure Connections Power supply Safety system Switch off pressure Dosage of the insulin Basal rate Bolus and priming the infusion set Accuracy of the dosing Bolus Basal rate Occlusion bolus volume 84 x 54x19 mm lt 100g batteries included Plastic Polycarbonate all edges rounded Operating 41 to 122 F 5 to 50 C Transport storage 40 to 149 F 40 to 65 C Operating 10 to 90 Transport storage 10 to 100 Operating 700 to 1060 mbar Transport storage 50 to 1060 mbar serial interface only for servicing two 3 volt silver oxide proprietary batteries 2 micro processors alarms with automatic STOP max 4 x 10 Pascal 4 bar 1 20 of basal rate every 3 minutes Continuously with a rate of 9 U minute 20 U 100 at min bolus 0 5 U lt 0 1 U at max bolus 25 U lt 0 3 U at 10 U h lt 5 lt 4 5 U plastic cartridge lt 10 U glass cartridge H TRONplus Reference Manual 89 11 2 List of symbols A Ui Read instructions for use STERILE EO Sterilized with ethylene oxide STERILE R Sterilized with radiation STERILE A Sterilized with antiseptic mi Date of manufacture LOT Batch number b Expiration date REF Item number Serial number Permissible temperature range Permissible humidity range Pe
9. 2 Program a bolus status RUN The amount of a bolus is determined by your health care team s guidelines based on your blood glucose value your food intake and your activity level To program a bolus the H TRONplus must be in RUN If during programming before entering a bolus amount no button is pressed for eight seconds the pump returns to the default RUN display Caution Determine with your doctor or health care team the quantity of H insulin you need to administer Be certain you know your personal carbo hydrate insulin ratio and your blood glucose correction ratio 1b 4b 1 gt Press either h or m The pump beeps three times and the RUN cursor points to bolus g o bolus 3 a Within eight seconds press the same button repeatedly to eS ee increase the bolus to reach the desired amount 1h 4h 3 Eight seconds after the last button press the pump beeps once RUN for each time h or m was pressed These are called confirma _ gt bolus tion beeps 1S 46 H TRONplus Reference Manual Note the confirmation beeps will not sound if the beeps are silenced See section 6 3 control the beeps after another eight seconds the bolus delivery 1 lb 1b begins and a bolus countdown shows on the gt bolus display 14 after another 22 seconds the display goes blank possibly during delivery to save power However the full bolus will be delivered The display may be illuminated during delive
10. 37 4 1 4 Attach the infusion set and insert the cartridge into the cartridge compartment Steps 23 to 30 37 4 2 Half fill the plastic cartridge 0 ccc cece eee eens 38 2 H TRONplus Reference Manual H TRONplus Reference Manual 3 4 3 Fill the cartridge using the EasyFill 00 00 e cence eee 39 7 7 Alarm ERROR 07 System Alarm 0 02 00 cece eee eee eee 67 4 3 1 Prepare the cartridge Steps 1 to 7 0 0c cee eee 39 7 8 Alarm ERROR 8x Technical Inspection Alert 0000 68 4 3 2 Fill the cartridge using the EasyFill Steps 8 to 15 40 7 9 Alarm ERROR 09 Technical Inspection Due 00 69 4 3 3 Remove the cartridge from the EasyFill Steps 16 to 21 40 7 10 Alarm ERROR 10 Cartridge Low Warning 00000 70 4 4 Reset new cartridge cece cece eee teen eee 41 7 11 Alarm ERROR 11 End of Temporary Basal Rate 71 4 4 1 Reset new full cartridge ccc eee eee eee 41 8 Troubleshooting guide 72 4 4 2 Reset new half full plastic cartridge 00000 42 8 1 Blank display cise eis sa cde e eh eed eee e eee eee ne awa 72 AS Prime the infusion SEL tice 00a sl cePniohdnetoae el iwatiaddoay 42 8 2 Incomplete full segment display insert batteries 73 4 6 Select and prepare an infusion site 00 c cece e ee aes 43 8 3 Incomplete start up self check 000 0c cece 73 5 Operate your H
11. Manual 33 4 Prepare the cartridge and attach the infusion set This section includes 4 1 Fill the cartridge 4 1 1 Prepare the cartridge Steps 1 to 7 4 1 2 Fill the cartridge Steps 8 to 17 4 1 3 Insert the piston rod into the cartridge Steps 18 to 22 4 1 4 Attach the infusion set and insert the cartridge into the cartridge compartment Steps 23 to 30 4 2 Half fill the plastic cartridge 4 3 Fill the cartridge using the EasyFill 4 3 1 Prepare the cartridge Steps 1 to 7 4 3 2 Fill the cartridge using the EasyFill Steps 8 to 15 4 3 3 Remove the cartridge from the EasyFill Steps 16 to 21 4 4 Reset new cartridge 4 4 1 Reset new full cartridge 4 4 2 Reset new half full plastic cartridge 4 5 Prime the infusion set 4 6 Select and prepare an infusion site Warning Use only fast acting U 100 insulin prescribed by your doctor or health care professional Caution Use only the specified cartridges The cartridges are sterile prod ucts intended for single use only Sterility is guaranteed for unopened packaging up to the indicated expiration date Do not use if package is damaged Do not reuse single use materials Reuse of single use mater ials might lead to a malfunction and to the administration of an incorrect amount of insulin Always work with clean hands 4 1 Fill the cartridge A Warning Air bubbles in the cartridge cause the infusion of air instead of insulin Your body will not receive the required amount of insulin An
12. Reference Manual 97 With a disconnect infusion set do the following 1 gt Press S and hold for three seconds to silence the alarm ERROR 04 stays on the display 2 gt Check blood glucose If elevated treat according to your health care team s instructions Then Disconnect the infusion set from the site Prime ge OE cal If no ERROR 04 If continued ERROR 04 Insert new infusion set Remove cartridge Reconnect and change adaptor and piston rod to RUN Prime empty pump If no ERROR 04 l Insert cartridge piston If continued ERROR 04 rod adaptor and infusion Change Motor battery 2 set Remove infusion set and prime from adaptor Prime Lee If continued ERROR 04 If no ERROR 04 Switch to back up insulin Insert cartridge piston delivery device and call rod and adaptor Prime Disetronic tubing Reconnect and change pumpt to RUN IF no ERROR 04 Attach new infusion set prime and reconnect Change pump to RUN r If no ERROR 04 If continued ERROR 04 Ch to RUN Remove cartridge and piston Ae PUMpAO rod Replace with new cartridge if continued ERROR 04 and new piston rod Reset gee Switch to back up insulin Say tor oe cartridge attad delivery device and call new infusion set and prime Disetronic 98 H TRONplus Reference Manual Operating the H TRONplus Quick programming reference STOP data RUN units I
13. When the alarm ERROR 03 will not clear and the pump will not change to RUN change the battery immediately Do not remove both batteries at the same time after a battery alarm in order to keep the data memory Change only the battery in compartment 3 when the pump alarms ERROR 03 Always keep extra batteries immediately available Keep batteries in their original package Caution For preventing water from entering the pump case l Change pump batteries only in a dry environment When changing a battery check that the black O ring is correctly in stalled and seated properly 7 4 Alarm ERROR 04 Occlusion please see scheme on page 98 An ERROR 04 may be caused by Taree An empty cartridge Ic A reused cartridge ERROR A blocked infusion set 04H A dirty or damaged piston rod A low battery in compartment 2 motor When one of these conditions occurs the pump motor stops When the motor stops the pump alarms ERROR 04 changes to STOP and beeps continuously 62 H TRONplus Reference Manual If an alarm ERROR 04 appears check your blood glucose value because delivery of insulin may have been interrupted for several hours If blood glucose is high treat according to your health care team s instructions With a disconnect infusion set do the following 1 gt Press S and hold for three seconds to silence the alarm ERROR 04 stays on the display 2 gt Check blood glucose If elevate
14. allow you to schedule the inspection 68 H TRONplus Reference Manual ERROR 88 8 weeks before the technical inspection is due ERROR 86 6 weeks before the technical inspection is due ERROR 84 4 weeks before the technical inspection is due ERROR 82 2 weeks before the technical inspection is due When the pump alarms with a technical inspection alert ERROR code it stays in RUN and beeps continuously Do the following 1 gt Press S and hold for three seconds to silence alarm ERROR 8x stays on the display 2 gt Press S to clear the display 3 gt Call Disetronic at 1 800 688 4578 to receive instructions on how to return the pump for technical inspection 7 9 Alarm ERROR 09 Technical Inspection Due After 24 months of use with batteries inserted in the pump the pump alarms ERROR 09 and beeps continuously It changes to STOP The pump s computer counts the time the pump is used before the technical inspection is due When the batteries are removed the pump does not monitor time Do the following 1 gt Press S and hold for three seconds to silence alarm ERROR 09 stays on the display 2 gt Change to your back up insulin delivery device 3 gt Call Disetronic at 1 800 688 4578 to receive instructions on how to return the pump for technical inspection H TRONplus Reference Manual 69 7 10 Alarm ERROR 10 Cartridge Low Warning When only 20 units standard setting see section 2 4 remain in the
15. and the electronic battery 3 Bolus The amount of insulin delivered at one time to cover food or elevated blood glucose value or other special needs Cartridge An insulin reservoir designed to be used in the insulin pump Cartridge compartment The opening in the pump for the cartridge Cog wheel The nylon wheel on the piston rod Display LCD Liquid Crystal Display The visual display on the insulin pump Programming information appears in the display 92 H TRONplus Reference Manual Dual microprocessors The computerized electronic components that control the operation of the pump Infusion set The connector consisting of a luer lock connector tubing and needle that carries insulin from the pump cartridge to the insulin pump user s body Infusion site The place where the infusion set needle is inserted in the skin to deliver insulin Luer connector luer lock A fitting at the end of the infusion set and on the cartridge which allows them to be locked together without leaking Multiple basal rates More than one basal rate delivered within a 24 hour period Up to 24 hourly rates may be programmed with the H TRONplus Insulin Pump The rates are changed at time intervals set by the insulin pump user Nylon end cap The portion of the piston rod that fits into the plunger inside the cartridge The nylon end cap pushes the cartridge plunger when the piston rod is rotated by the motor Profile A basal rate profile co
16. basal rate display time to AM PM time when you are programming your basal rates Example Ifthe pump basal rate display is 03 04 the AM PM time is 3 AM to 4AM Ifthe pump basal rate display is 16 17 the AM PM time is 4 PM to 5 PM Pump basal AM PM Pump basal AM PM time Pump basal AM PM time rate display time rate display rate display 00 01 12 1 AM 08 09 8 9 AM 16 17 4 5 PM 01 02 1 2 AM 09 10 9 10 AM 17 18 5 6 PM 02 03 2 3 AM 10 11 10 11 AM 18 19 6 7 PM 03 04 3 4 AM 11 12 11 AM 12 PM 19 20 7 8 PM 04 05 4 5 AM 12 13 12 1 PM 20 21 8 9 PM 05 06 5 6 AM 13 14 1 2 PM 21 22 9 10 PM 06 07 6 7 AM 14 15 2 3 PM 22 23 10 11 PM 07 08 7 8 AM 15 16 3 4 PM 23 24 11 PM 12 AM 30 H TRONplus Reference Manual 3 4 2 Program the same basal rate for several hours A basal rate can be copied for one or more hours If during programming no button is pressed for 12 seconds the cursor returns to basa Twelve seconds after the basal rate total is displayed the pump returns to the default STOP display To copy the basal rate 1 Refer to section 3 4 1 program a basal rate for each hour step 1 and 2 and gt press S to select the hour to be copied 2 gt Within 12 seconds press and release h and m at the same time the basal rate is copied to the next hour continue to press h and m to copy the basal rate for as many hours as needed 3 Twelv
17. button for at least 3 seconds The pump will l 1 discharge any static load to prevent electronics problems 3 3 gt Take one battery out of the packaging and check to see i if the O ring is present and correctly placed f o g 4 gt Always place a new battery into compartment 2 3 electronic first Always turn the battery until it is 8 tight Tight means the top of the battery is level with the pump case DO NOT OVER TIGHTEN AND USE THE MMM BATTERY TOOL 4 gt ONLY The display illuminates D Hlo and shows four lines of numbers and words and eight cursors 5 gt Take a second battery out of the packaging and check to see if the O ring is present and correctly placed 99 98 gt 6 gt Screw this second battery into compartment 2 motor 4 STOP RUND Always turn the battery until it is tight Tight means the top lt ERROR gt of the battery is level with the pump case DO NOT OVER 5 5 5 5 gt TIGHTEN 7 gt Press any button to start the pump self check During this countdown on the display all electrical systems are checked A short beep sounds when the pump self check starts The numbers from 0 to 9 scroll on the display EE A long beep sounds at the end of the pump self check The pump is automatically set to STOP If the pump displays ERROR 07 remove both ba
18. by the basal rates over 24 hours 2 gt Within 12 seconds press S again to select the first gt units_ hour The display shows the first hour as 00 01 which means midnight to 1 00 AM It also displays the basal rate for this hour 3 gt Within 12 seconds press the h button to increase the basal rate Press the m button to decrease the basal rate Optional scrolling If h or m is held down the display increases or decreases five numbers and then scrolls through the numbers quickly Hold h or m until the desired basal rate is reached Hie 4 gt Within 12 seconds press S to select the next hour The gt units display will advance one hour and shows basal p b H TRONplus Reference Manual 29 01 02 which means 1 00 AM to 2 00 AM The basal rate for this hour Press h or m to increase or decrease the basal rate 5 gt Program the remaining hours by pressing S to advance the hours and h or m to increase or decrease the basal rate Remember to program all 24 hours 6 Twelve seconds after the last button is pressed the pump returns to the basal rate total Check the basal rate total to ensure it is correct Do this by adding up the rates for all 24 hours This amount should equal the amount shown on the display 7 Twelve seconds after the basal rate total is displayed the pump returns to the default STOP display showing insulin remaining Use this table to convert the pump
19. cartridge the pump alarms ERROR 10 The pump beeps continuously to warn you that the cartridge is almost empty Do the following 1 gt If the pump alarms ERROR 10 during basal delivery the pump beeps continuously and displays RUN Press any button to silence the alarm ERROR 10 stays on the display Press S to clear the ERROR display and to determine the insulin remaining Change the cartridge before it is empty 2 gt If the pump alarms ERROR 10 during bolus delivery the pump beeps continuously and displays RUN You may silence the alarm immediately or wait to silence the alarm after the bolus If you want to silence the alarm immediately Press any button to silence the alarm ERROR 10 stays on the display Press S and the insulin remaining will continue to decrease on the display for 8 seconds then the display switches to show the bolus amount The bolus amount continues to decrease on the display Change the cartridge before it is empty If you want to silence the alarm after the bolus Press any button to silence the alarm ERROR 10 stays on the display Press S to clear the display and to determine the insulin remaining Change the cartridge before it is empty 3 gt If the volume of insulin in the cartridge reaches twenty units remaining while priming the pump continues the prime When the prime is complete the display shows ERROR 10 beeps 70 H TR
20. from the cartridge by turning and pulling it 20 gt Push the cartridge protective cap TIGHTLY onto the cartridge until it is snug 40 H TRONplus Reference Manual 21 gt Remove the plunger rod by turning it counterclockwise out of the plunger Take care not to move the plunger during removal The cartridge is now ready for the insertion of the piston rod To A insert the piston rod into the cartridge go to section 4 1 3 y 4 4 Reset new cartridge status STOP Warning With every cartridge change you must reset the pump either to 315 0 or 150 0 U to correspond to the cartridge contents Otherwise the counter for the actual cartridge volume will be inaccurate This will lead to inappropriate alarms The alarm ERROR 04 will occur instead of the alarms ERROR 10 or ERROR 01 when the cartridge is empty 4 4 1 Reset new full cartridge 1 gt Press S until the cursor points to reset _reset 4 STOP 2 gt Within eight seconds press h and m at the same time 4 and release The display scrolls from 0 to 9 Pump self check When the scrolling is complete a long beep sounds 315 0 appears and the cursor points to data og 00 11 99 If during programming no button is pressed for eight seconds the pump returns to the default STOP display H TRONplus Reference Manual 41 4 4 2 Reset new half n plastic cartridge gt Press S until the cursor points to reset gt Wit
21. installed and seated properly The full segment display illuminates If not then change to your back up insulin delivery device Call Disetronic at 1 800 688 4578 8 3 Incomplete start up self check The pump performs a self check when the pump is started for the first time both batteries are removed and reinserted or replaced the pump is reset for a new cartridge If the pump fails a start up self check then 1 gt remove both batteries 2 gt press S and hold for three seconds 3 gt insert a battery in compartment 3 electronic if the display illuminates go to step 4 H TRONplus Reference Manual 73 if the display does not illuminate remove the battery go to step 5 4 gt Press S and wait for the numbers to scroll from 0 to 9 if the pump alarms ERROR 02 silence alarm ERROR 02 stays on the display Press S to clear the display The self check is com plete Continue with programming if the pump alarms ERROR 07 ERROR 03 or if the display freezes remove the battery go to step 5 5 gt Press S and hold for three seconds Insert NEW battery in com partment 3 electronic according to section 3 1 if the pump alarms ERROR 02 silence the alarm self check is complete Continue with programming if the pump alarms ERROR 07 ERROR 03 or if the display freezes remove the battery Got to step 6 6 gt Change to your back up insulin delivery dev
22. it may be programmed When the pump is in RUN insulin is delivered at the preprogrammed basal rate and boluses may be programmed if required To determine whether the pump is in STOP or RUN press both h and m at the same time for one second The pump displays the actual status either STOP or RUN To change from STOP to RUN status STOP 1 gt Press h and m at the same time and HOLD for three seconds 2 The pump sounds one long beep WEEE when the buttons are pressed and then three short beeps when RUN appears RUN Units 3 Once the pump is in RUN the display will show the programm ed actual time the current hourly basal rate and the status RUN H TRONplus Reference Manual 45 To change from RUN to STOP status RUN 1 gt Press h and m at the same time and HOLD for three cae seconds ib 45 gt data 2 The pump sounds three short beeps when the buttons are pressed an then one long beep HEEE when STOP appears in the display The display will show the time STOP and the amount of insulin remaining STOP Alarm When the pump is in STOP it beeps once every minute to remind you that it is stopped and that no insulin is being delivered This beeping is the STOP Alarm The stop alarm is activated when the pump is first changed to RUN and then returned to STOP It can be silenced see section 6 4 control the STOP Alarm To re activate the STOP Alarm put the pump in RUN and then into STOP 5
23. of insulin since midnight 6 1 3 Recall recent boluses 6 1 4 Recall alarm messages 6 2 Set temporary basal rate 6 2 1 Set temporary basal rate increase 6 2 2 Set temporary basal rate decrease 6 3 Control the beeps 6 4 Control the STOP Alarm 6 5 Basal rate lock unlock M Warning Incorrect programming of the pump will lead to an incorrect dose of insulin Do not operate the H TRONplus Insulin Pump without knowing your personal settings The pump must be programmed with your personal settings prior to starting the therapy Make sure that if you are not experienced your doctor or health care professional checks your personal settings 6 1 Recall data memory status RUN Caution If both batteries are removed at the same time some data memory information insulin remaining total amount of insulin delivered since midnight boluses delivered ERROR messages in the pump is lost If only one battery is removed and replaced data memory is not lost The H TRONplus memory stores the following information Insulin remaining in the cartridge Total amount of insulin delivered since midnight Recent boluses delivered including the time and amount of the last 10 boluses ERROR Messages including the time and code of the last five alarms H TRONplus Reference Manual 49 To access data the pump must be in RUN By pressing S repeatedly the pump displays the entire sequence of data information If S is not pressed withi
24. reset the pump for a new cartridge attach a new infu sion set and prime If the pump does not alarm ERROR 04 change the pump to RUN Insert the infusion set to a newly prepared infusion site after making sure that insulin is dripping from the needle and there is no air in the system If the pump alarms ERROR 04 go to step 7 7 gt Change to your back up insulin delivery device or contact your health care team for an alternate insulin therapy plan Call Disetronic at 1 800 688 4578 Note The piston rod needs to be replaced every 12 months The adapter needs to be replaced every 6 months A damaged or worn out piston rod or adapter could lead to an ERROR 04 7 5 Alarm ERROR 05 Bolus Limit Reached A safety limit on the amount of bolus insulin that can be delivered in a period of time may be set with special programming This alarm is not activated by Disetronic unless ordered by your health care team When programmed the display shows ERROR 05 if the bolus limit is reached The pump remains in RUN and beeps continuously The alarm does not affect the basal insulin de livery H TRONplus Reference Manual 65 Do the following Silence alarm by holding S for three seconds ERROR 05 stays on the display Press S to clear the display Contact your health care team about the need to possibly re evaluate the bolus limit The range of the preset bolus limit can be modified by Disetronic upon written confir
25. selected function and return to the Ih im gt to the next hour Input of the bolus volume preceeding function or the actual 1 bolus step pressing Km status fh gt m gt S gt Basal rate lock PrL unlock PrU Reset to 0 0 lt hi H TRONplus Reference Manual 99
26. the insulin bottle Note that the filling needle has punctured the i 8 gt Set the bottle of insulin on a hard surface like a table Ld Ki 4 gt vy rubber membrane of the insulin bottle ea 12 gt Push the plunger rod down so that all air from the cartridge S hi enters the insulin bottle 13 gt While holding steady pressure against the plunger rod with your thumb invert the bottle so that the filling needle and cartridge are pointing upwards into the insulin bottle Remove your thumb from dB the plunger rod Insulin will begin to fill the cartridge Do not pull on the plunger rod while it is moving to avoid unnecessary forma tion of air bubbles 14 gt Slowly pull the plunger rod in a straight line and completely fill the cartridge o Caution Remove any air bubbles by tapping on the cartridge to dislodge them Push them back into the insulin bottle with the plunger rod 15 The cartridge is full when there are no air bubbles and the plunger is at the bottom of the cartridge When using the EasyFill the plunger cannot be pulled out of the cartridge 4 3 3 Remove the cartridge from the EasyFill Steps 16 to 21 16 gt Remove the insulin bottle from the EasyFill bottle holder 17 gt Put the protective needle cover on the filling needle 18 gt Remove the cartridge and the filling needle with the protective needle cover from the EasyFill 19 gt Remove the filling needle and protective cover
27. the phone is in use Security systems for transit checks in airports as well as anti theft monitoring devices installed in department stores shops etc are harmless and do not affect the function ing of the insulin pump 1 2 Precautions Accessories and disposables Caution Only use accessories and disposable materials that are designed expressly for use with the pump Other accessories and disposable l materials may not have been checked for compatibility with the H TRONplus Insulin Pump and may therefore endanger your health if used Always have extra accessories and disposable materials with you This will allow you to exchange components when needed 1 0 H TRONplus Reference Manual Batteries Caution Always have extra batteries available and pay attention to the 4 following Do not store the batteries in the refrigerator or freezer High humid ity affects battery life Always keep batteries in the original package until ready to use Prevent early discharge of the batteries by preventing contact bet ween the batteries themselves and between the batteries and any other metal coins keys etc For operating the pump the temperature of the batteries must be 41 F to 122 F 5 C to 50 C Change pump batteries only in a dry environment When changing a battery check that the black O ring is correct ly installed and seated properly To tighten batteries use only the Disetronic battery
28. the pump returns to the default RUN display 2 gt Within 12 seconds press again and the second most recent bolus is displayed bolus The cursor still points to bo us The top line of the pump display alternately flashes 02 and the time of the second most recent bolus 02 means the second most recent bolus The bolus amount is on the bottom line 3 Press S repeatedly to recall remaining boluses Bolus amounts and times are recalled in sequence 03 04 etc If S is not pressed within 12 seconds the pump returns to the default RUN display gt bolus 6 1 4 Recall alarm messages The H TRONplus memory stores information on the last five alarms If the pump has not had five alarms since both batteries were inserted at the same time the pump will only display the alarms that have occurred To recall alarm messages the pump must be in RUN 09 13 1 gt Press S until the word ERROR appears in the display _ g Notice that there are no cursors AUN a The display alternately flashes 01 and the time of the last alarm on the top line 01 means the last alarm The ERROR code is on the bottom line If S is not pressed again within 12 seconds the pump returns to the default RUN display 2 gt Within 12 seconds press again and the second most recent alarm message is displayed H TRONplus Reference Manual 51 The top line of the pump display alter
29. to pain a lump redness heat or drainage you should change infusion sites regularly according to the infusion set package insert The H TRONplus is now ready for operation this means you may change the status of the pump to RUN Note After inserting a new soft cannula type infusion set you must bolus to fill the air space in the cannula to get insulin to the tip according to the infusion set package insert Failure to do this step could result in missed insulin possibly leading to hyper glycemia 44 H TRONplus Reference Manual 5 Operate your H TRONplus This section includes 5 1 Start and stop pump delivery 5 2 Program a bolus 5 3 Cancel a bolus 5 4 Change a cartridge and an infusion set 5 5 Change an infusion set only Once the H TRONplus is set up you can start operating the device Warning Only change the pump to RUN if the pump is fully and correctly equipped including filled cartridge adapter primed infusion set and pro grammed with your personal settings The operating status of the H TRONplus may be either STOP or RUN In RUN the word RUN appears in the display and the pump delivers insulin In STOP the word STOP appears in the display and the pump does NOT deliver insulin The operations can only be performed if the H TRONplus is in the correct operating status 5 1 Start and stop pump delivery status RUN STOP When the H TRONplus Insulin Pump is in STOP it does not deliver insulin but
30. your health care team about when and for how long insulin pump therapy can be interrupted for example to go into a sauna during sport activities with hard body contact or swimming Short interruption 1 Change the pump to STOP 2 Completely remove the infusion set and close the cartridge with a protective cap Or using a disconnectable infusion set disconnect at the site and put the protective covers on the connectors 3 Silence the STOP Alarm refer to section 6 4 control the STOP Alarm H TRONplus Reference Manual 79 Measure your blood glucose value regularly during the interruption Inject insulin according to the instructions of your health care team with a syringe or insulin pen Continuation of the therapy 1 Attach a new infusion set and prime it prior to inserting it into your body Or for the disconnectable infusion sets reconnect the tubing to the needle There is no need to bolus for air space when re connecting 2 Change to RUN Within two hours measure your blood glucose value in order to check the operation of the system and to ensure insulin delivery Interruption of the operation of the pump for a longer period of time Caution Contact your health care team for an alternate therapy plan when e you will be off the pump for a longer period of time Interruption of pump operation for more than one day for example when storing the pump and using your other pump if available when wishing not to
31. 6 months of use 10 2 5 Cartridge and infusion set Caution The cartridge and the infusion set are sterile products and only for single use Replace and discard these items according the instructions of your health care team and according the specifications in the corresponding instructions for use 10 3 Store the pump When the pump will not be used for a long time it must be properly stored To store the pump remove both batteries Removing the batteries turns the pump off so the internal clock that monitors the time the pump is used is also turned off replace the battery compartment covers and the pump adapter store the pump in its original case Storage conditions Temperature 40 to 149 F 40 to 65 C Air humidity 10 to 100 Barometric pressure 500 to 1060 mbar 10 4 Battery information Caution For preventing water from entering the housing Change pump batteries only in a dry environment When changing a battery check that the black O ring is correctly install ed and seated properly H TRONplus Reference Manual 85 Caution Removing both batteries simultaneously will cause the data memory to be erased including current settings such as temporary basal rate changes or programmed bolus the loss of the remaining cartridge volume the history of alarms ERROR 10 and ERROR 01 and the time setting Reinsert the batteries according to section 3 1 1 insert the batteries after having
32. 8 Reset for a new cartridge STOP 41 Prime the infusion set STOP 42 Change the pump status start and stop pump delivery STOP RUN 45 Program a bolus RUN 46 Special functions Recall data memory RUN 49 Set temporary basal rates STOP 52 Control the beeps STOP 55 Control the STOP Alarm STOP 56 Basal rate lock unlock STOP 57 1 6 H TRONplus Reference Manual 2 4 Programmable settings Warning Incorrect programming of the pump will lead to an incorrect dose of insulin Do not operate the H TRONplus Insulin Pump without knowing your personal settings The pump must be programmed with your personal settings prior to starting the therapy Make sure that if you are not exper ienced your doctor or health care professional checks your personal settings Caution Prior to using a replacement a spare or a new pump always check the settings in order to avoid an incorrect dosage Your H TRONplus is supplied by Disetronic with a standard program You may need to change these standard programmed values to meet your needs after discussion with your doctor or health care team The following settings can be changed by Disetronic if requested by your doctor Setting Standard Ranges basal rate step 0 1 U 0 1 10U maximum hourly basal rate 10 U 1 40 U bolus step per push of a button 0 5 U 0 1 1 9 U maximum single bolus 25 U 0 1 95 U Option Bolus limit within a specified time frame
33. Basal Rate Silence alarm 71 ID 4201965 V03 03 03 Swiss made 01 23 Explanation of the symbols and markings safety instruction A N See instructions in the reference manual C 01 23 Marking of conformity according to the European Medical Device Directive MDD 93 42 EEC with the number of the notified body 0123 IPX7 Pump case protects the pump against the effects of temporary immersion in water according to the standard IEC 60529 Protection only if pump case is not damaged and the batteries are properly inserted N Warning Avoid any contact of the pump with water Electronic device of type BF according to the standard IEC 60601 1 Protection against electric shock Meaning of the safety symbols Warning Disregarding this warning may seriously harm your health or cause a defect of the device and or its accessories Caution Disregarding this safety instruction may harm your health or cause a malfunction of the device and or its accessories In section 11 Technical data under 11 2 is a list of additional symbols of the pump and the accessories H TRONplus Reference Manual 1 IE meyer csic Page Introduction safe and efficient use of the H TRONplus Insulin Pump 6 1 Warnings and precautions 7 Tel Warnings gaiman agiman aa eed New Ne ee 7 TZ PrecattionS siiig cs sinian g iena weaned Gli a ala Sia a 10 2 Description and functions of the H TRONplus 13 2 1 Safety and warning inst
34. Dear H TRONplus pump user Congratulations on your new H TRONplus Insulin Pump You and your H TRONplus R efe rence M anua Insulin Pump are unique Therefore it is important that you or your health care team r fill in the following information id S Type of device H TRONplus A Serial number Insulin name type U 100 Training Place Date s Trainer Useful adresses Your contact for medical emergency and or information about the therapy Doctor health care provider Phone Your contact for assistance with and or additional information about the H TRONplus Insulin Pump D piseTRONIC Disetronic Medical Systems Inc 5151 Program Avenue St Paul MN 55112 1014 USA Phone 1763 795 5200 Toll free 1800 280 7801 Fax 1 763 795 5300 info disetronic usa com www disetronic usa com h button m button Front TL gaY Display data mime a ail S 3 D ga E3 L3 reset bolus _clock temp i pasa pA Pump adapter Pump type Back Battery compartments Error code list Serial number Manufacturing date Cartridge compartment Cartridge Battery tool a adapter Batteries Cartridge plunger z v Electronic 3 Motor 2 fo a Piston rod a Q ERROR CODES 1D 420 0545 V03 03 01 01 Empty Cartridge 07 System Alarm 02 Low Motor Battery 2 8x Technical Inspection Alert 03 L
35. ONplus Reference Manual 0 Occlusion 9 62 81 89 Operating status 16 21 45 94 P Piston rod 19 37 84 Precautions saio ka siihla ie on out 10 Power Supply see batteries Programmable settings 17 Programming 8 17 28 49 Pump checklist ci 055008eee ees 87 R Recall datamemory 49 Reset new cartridge 41 93 Reali ate cctios entails Patience dys 82 Return the pump 88 BUN Bc idan Sond a eae ioe des 16 Recall months remaining to TSI 25 S Safety SYMDONS sacssr ess rieisrs as 1 systeM o oru aiurea nuas 59 89 Scrolling euina ket eandaa kes 15 28 Stans aeei ieee d e da am 45 STATUS fesse cs eee chan Vande mn ans 16 94 SO perinne a owen 45 Storage aa Ra 85 Subcutaneous oc oda eden aco aa 94 ee eee re err 11 SYMBOLS oheisen 1 22 90 System Alarm nannan aaan 67 System Check sass cetecwawanees 83 Serialnumber Cover page T Technical data 89 Technical Inspection 25 68 82 88 Alarm ERROR 8x Technical Inspection Alert 68 Alarm ERROR 09 Technical Inspection Due 69 Temperature 11 89 Temporary basal rate 17 52 71 94 Therapy situations 74 Total amount of insulin since midnight50 U UV radiation ccs ceiee cesses 11 wW Water cc cee ee eee 1 7 84 Warnings 0 000e eee 7 H TRONplus
36. ONplus Reference Manual continuously and displays STOP Press any button to silence the alarm ERROR 10 stays on the display Change the cartridge immediately or change to RUN and change the cartridge before it is empty 7 11 Alarm ERROR 11 End of Temporary Basal Rate The pump alarms ERROR 11 and beeps continuously when a temporary basal rate change increase or decrease has ended or has been canceled 1 gt If the change has ended the pump alarms ERROR 11 and displays RUN Press any button to silence the alarm ERROR 11 stays on the display Press S to clear the ERROR display 2 gt If the change has been canceled the pump alarms ERROR 11 and displays STOP Press S to silence the alarm ERROR 11 stays on the display Change to RUN H TRONplus Reference Manual 71 8 Troubleshooting guide This section includes 8 1 Blank display 8 2 Incomplete full segment display insert batteries 8 3 Incomplete start up self check 8 4 Therapy situations 8 1 Blank display When the pump is in RUN or STOP the display will be blank after 30 seconds in order to save battery power To illuminate the display 1 Press h and m at the same time this is the safest way Any other button can also be pressed but then not only is the display illumi nated but the function related to this button will also be activated If the display is not illuminated then do the following 2 Reinsert the batteri
37. OP display The cursor points to data Inspect your infusion set for any excessive air bubbles status STOP Caution Never insert an infusion set into an infusion site without having removed all air from the infusion set Caution Always follow the instructions given by your doctor or health care team Follow the instructions given in the instructions for use of the infusion set you are using H TRONplus Reference Manual 43 Caution When blood is detected in the infusion set you have most likely nicked a blood vessel causing the risk of an occlusion of the infusion set Select a new infusion site and replace the infusion set Site selection Your health care team will help you select your infusion site areas according to a planned site rotation pattern Site preparation Proper site preparation is essential to reduce the risks of infection Your health care team will give you site preparation guidelines such as Wash your hands thoroughly Scrub the infusion site with an antiseptic Insert the infusion set needle according to the instructions for your infusion set Use transparent site dressing and safety loop if necessary Inspect the site at least once or twice each day for irritation or infection if you see redness or swelling change the infusion set immediate ly if there is infection change immediately and contact your health care team Signs of infection may include but are not limited
38. TRONplus 45 8 4 Therapy situations 6c iae ivan evened een ewe end decane dans 74 5 1 Start and stop pump delivery 0 c cece cece ence ees 45 9 Special situations 79 5 2 Program a bolus Kasdan Lavatdna vara Pkdadn aha diane ee tak aw ae 46 9 1 Recommendations for daily use 1 6 eee eee 79 5 3 Cancel a Dolus gidsuceeadugseedns Vehse eee Fase eSiue Gnas 47 9 2 Interruption of pump therapy ce siac tive ase eaeweueace anes 79 5 4 Change a cartridge and an infusion set 0 00 cece eens 47 9 3 Use of a partially filled cartridge plastic cartridges only 81 5 5 Change an infusion set only 000s cece e eee eens 48 10 Maintenance and cleaning 82 6 Program other functions special functions 49 10 1 Repair and technical inspection cece eee eee es 82 6 1 Recall data memory co00c es26ees cree sicoeed ieeesassdeuee 49 10 2 Maintenance and cleaning 0 2 eee e eee eee 83 6 1 1 Recall insulin remaining 0000 c eee eee eens 50 10 2 1 System check cs once voce wigs ogee died eigeamng ed we 83 6 1 2 Recall total amount of insulin since midnight 50 102 2 SU PUMP rras 9 oe Siri we eS min wR eX ware whe ws 83 6 1 3 Recall recent boluses 00 cece eee eee ee 50 10 23 PIStON TOG argian nea ae a i ahs Simin oa tase 84 6 1 4 Recall alarm messages ccc eee e eee eens 51 102 4 PUMP AED issii sag prsa ieej saagaa eina ana ri 84 6 2 Set temporary basal rate
39. Time frame OFF 1 24 hours Bolus limit OFF 0 99 9 U Bolus limit reached ERROR 05 OFF 0 99 9 U Temporary basal rate increase 12h 1 24h Temporary basal rate decrease 4h 1 24h Automatic off ERROR 06 OFF 0 24h Cartridge low warning ERROR 10 20 U 10 50 U H TRONplus Reference Manual 1 7 If the parameters set in your pump do not meet your needs changes can be made by Disetronic Consult your doctor or health care team about your personal programming If in doubt please contact Disetronic to discuss how to proceed 2 5 Accessories and disposables Caution Use only specified accessories and disposables because only these items are tested for correct delivery of insulin when used with the pump The reuse of any materials designed for single use may increase the risk of an infection of a malfunction and of a wrong dosage Use the cartridge and the infusion set only once Regularly replace these items according to the instructions provided with the accessories Caution Most of the accessories and disposable materials are specially I designed for the use with the H TRONplus pump Always have extra accessories disposable materials and extra batteries available in order to prevent involuntary interruption of pump therapy Z Batteries Special PowerPacks The H TRONplus requires two 3 volt silver oxide batteries to power the Motor 2 electronics and the motor The compartments for the batteries are marked as fol
40. a battery operated microprocessor controlled insulin pump It is intended for subcutaneous infusion of insulin Please refer to the section 11 Technical data for additional technical information 2 1 Safety and warning installations of the H TRONplus The sound of an acoustic beep and a message on the display informs you about the status and or malfunctions of the H TRONplus and or the system Warning In case the beeps can not be heard e g in a noisy room check the display regularly This way you can detect malfunctions in a timely manner Beep display Description Alarms Continuous 11 alarms ERROR 01 to 11 indicate an ERROR beeping imminent or an actual malfunction or the Messages ERROR 01 11 completion of a function STOP 1 beep minute The pump is in STOP mode and is not delivering Warning STOP insulin This can be caused by user putting pump into STOP mode directly or as a result of a pump ERROR code H TRONplus Reference Manual 1 3 2 2 Handling and display Programming of the pump involves the use of three buttons the S h and m button All inputs are shown on the display and are followed by one or several short and or long MM beeps Audible beeps Graphic Duration and timing Signal description description of each signal of the signal Short beep Button pressed Long beep every minute Pump in STOP E 666 Long beep three short beeps Change to RUN
41. al to ensure it is correct baala J38 4 Twelve seconds after the basal rate total is displayed the pump returns to the default STOP display 3 5 Review basal rate programming status STOP The basal rates should be reviewed After any programming change When the batteries are changed After clearing an alarm ERROR 07 To review the basal rate programming the H TRONplus must be in STOP PEL 1 gt Press S until the cursor points to basa The display iP shows Pr U basal rate programming is unlocked and allows basal JPY basal rate changes Pr L will be displayed if the basal rate programming is locked Refer to section 6 5 basal rate lock unlock for more information Basal rate total amount of insulin delivered by the basal rates over 24 hours 2 Within 12 seconds gt press and release S repeatedly to review the basal rates or gt press and HOLD S and the display will scroll through the basal rates at one second intervals OO p _ units 32 H TRONplus Reference Manual 3 If a change is necessary at a certain hour increase or decrease with h or m Twelve seconds after the last button is pressed the pump returns to the basal rate total Check the basal rate total to ensure it is correct Twelve seconds after the basal rate total is displayed the pump returns to the default STOP display H TRONplus Reference
42. allations of the H TRONplus 13 272 Handling and Wel ay ac voatan aerate ads betenese es s 14 2 3 Operating status STOP RUN n on teboige ta ieh Giger Gsesad 16 2 4 Programmable settings 000 cece eee eee eee aes 17 2 5 Accessories and disposables 0c cece eee eee eeee 18 3 Set up your pump 21 3 1 Insert and change batteries n n cevavae ade ewawa an os ad s 22 3 1 1 Insert the batteries n gence ated hee ease eee ne 24 3 1 2 Change the batteries cc cece eee eee eee 25 3 2 Insert remove both batteries 00000 c cece eee eee 25 3 2 1 Insert both batteries 5 c0c 0sebeebssareibiesaaceuse 25 3 2 2 Remove both batteries 22 con csciads ee bs ebateaee ates 26 33 SEF MISCO sorene sah agen amin Daeg ua Rin aa eh eie 27 3 4 Program the basal rates iccida kreindyhekGtbadwhabede aden we 28 3 4 1 Program a basal rate foreach hour 0000s 29 3 4 2 Program the same basal rate for several hours 31 3 4 3 Change basal rates dv ciieadctewaves as tuvavsivrvaxwcs 31 3 5 Review basal rate programming c eee e eee eee ees 32 4 Prepare the cartridge and attach the infusion set 34 4 1 Fill th cartridg a i va i see Ss tle so id si es co 34 4 1 1 Prepare the cartridge Steps 1 to 7 cece eee 35 4 1 2 Fill the cartridge Steps 8 to 17 1 ee cee eee eee 36 4 1 3 Insert the piston rod into the cartridge Steps 18 to 22
43. an infusion site in your body Otherwise you risk uncontrolled delivery of insulin into your body With disconnectable infusion sets be sure you have disconnected prior to programming changing or priming Always follow the instruction for use of the infusion set you are using H TRONplus Reference Manual 9 Warning Check for chips and cracks if the pump is dropped Do not use the pump if it is chipped or cracked Inspect the pump daily for cracks or chips Check around battery compartments Also check the h m and buttons for cracks or damage Be sure that the buttons rebound when pressed Avoid chips and cracks by safely attaching your pump to your body or to your clothes Be sure that you can safely protect the pump while engaging in any sports with rough body contact like boxing football hockey or rugby Otherwise remove the pump Warning Avoid electromagnetic fields of radar or antenna installations of high voltage lines of power stations of X Ray sources MRI CAT scan or the like Do not use the pump in these areas If this situation is unavoidable you must take off the pump beforehand Otherwise elec tromagnetic fields can lead to defective functions in the pump s electronics and could result in ERROR 07 System Alarm Because of the variety of portable phones their influence on the pump cannot be ruled out completely It is advised to keep the pump at a distance of at least 4 inches 10 cm from the phone while
44. battery 2 for ERROR 02 compartment for the electronic battery 3 for ERROR 03 farthest from the cartridge chamber Always have extra batteries available and pay attention to the following Do not store the batteries in the refrigerator or freezer High humid ity affects battery life Prevent early discharge of the batteries by preventing contact between the batteries themselves and between the batteries and any other metal coins keys etc Always keep batteries in the orig inal package until ready to use For operating the pump the temperature of the batteries must be 41 F to 122 F 5 C to 50 C To tighten batteries use only the Disetronic battery tool until the top of the battery is level with the pump case Over tightening may cause pump case damage Use only Disetronic batteries Otherwise the settings and alarms may be incorrect and or the pump could be damaged Take the used batteries to a battery recycling location or if no such location exists return the batteries to Disetronic Please do not dispose of them in the household trash H TRONplus Reference Manual 23 3 1 1 Insert the batteries No battery is in the pump 1 gt Remove the protective covers from the battery compart 3 sec ments using the battery tool Store the covers igi f 2 gt Press the
45. ble settings unless programmed otherwise The pump beeps three times on the hour each hour as a reminder If the beeps have been turned off the pump will NOT beep three times on the hour as a reminder Ifthe beeps have been turned off the pump will NOT give confirm ation beeps The basal rate can be decreased to 0 The display shows 0 00 to indicate that it is programmed for 0 of the original basal rate No insulin will be delivered for 4 hours or as otherwise pro grammed An incorrect entry can be corrected before the confirmation beeps by pressing h once The basal level is returned to 1 00 100 of original basal rate The temporary decrease can be canceled by changing from RUN to STOP The alarm ERROR 11 confirms the cancellation Silence the alarm by pressing and holding S for three seconds Then either re program a new temporary basal rate decrease or change from STOP to RUN The delivery of a bolus does not interrupt the temporary basal rate decrease 54 H TRONplus Reference Manual After the 4 hour temporary basal rate decrease the pump automatically returns to the original basal rate The pump alarms ERROR 11 and beeps continuously to confirm the end of the tem porary basal rate decrease The pump remains in RUN Silence the alarm by pressing S for three seconds Press S again to clear the alarm message from the display 6 3 Control the beeps status STOP The H TRONplus In
46. d treat according to your health care team s instructions Go to step 3 3 gt Disconnect the infusion set from the site Prime If the pump does not alarm ERROR 04 again insert a new infusion set into the skin according to the instructions for use of the infusion set Reconnect infusion set to the site after making sure that insulin is dripping from the connector needle and there is no air in the system Change pump to RUN If the pump does alarm ERROR 04 go to step 4 4 gt Check to make sure that the infusion set is still disconnected from the site Remove the cartridge from the pump with piston rod adapter and infusion set attached Prime If the pump does not alarm ERROR 04 go to step 5 If the pump alarms ERROR 04 change battery in compartment 2 motor as described in section 3 1 2 and prime If the pump does not alarm ERROR 04 insert the cartridge with piston rod adapter and infusion set back into the pump Screw the adapter onto the cartridge chamber Prime until insulin drips from the end of the connector needle and there is no air in the system Reconnect the infusion set to the infusion site Put pump into RUN If the pump alarms ERROR 04 go to step 7 5 gt Insert cartridge with piston rod adapter and infusion set re attached to the pump Screw the adapter onto the cartridge chamb er Remove infusion set from the adapter Prime If the pump does not alarm ERROR 04 attach a
47. e and sec tion 4 5 prime the infusion set To change a cartridge and infusion set the pump must be in STOP 1 2 Wash hands Remove the infusion set from the body first then from the pump and discard it safely in the proper container Remove the cartridge from the pump and discard it in the proper container Save the piston rod for continued use Fill the new cartridge with insulin and attach the new infusion set as described in section 4 prepare the cartridge and attach the infusion set Note Some infusion sets require an extra bolus after initial insertion to take up the air space Refer to the insertion instructions of your infusion set 5 5 Change an infusion set only status STOP Change the infusion set according to the instructions for use of the infusion set you are using Remove the infusion set from the body first then from the pump and discard it safely in the proper container Attach a new infusion set to the pump Hold the pump vertically and prime the infusion set Repeat the prime sequence if necessary until insulin drips from the end of the needle Stop the prime by pressing any button when insulin begins to drip Insert the infusion set as described in section 4 1 4 attach the infusion set 48 H TRONplus Reference Manual 6 Program other functions special functions This section includes 6 1 Recall data memory 6 1 1 Recall insulin remaining 6 1 2 Recall total amount
48. e for the functions program the basal rate and set the clock In order to enter a particular value a button must normally be pressed several times However in certain situations if you hold down a pressed button the value will automatically change You can hold the button scroll until the desired value appears on the display The value can of course still be corrected with the buttons If you use the scrolling function check to make sure the entered values are correct No audible beeps are given by the pump while scrolling prime reset 49 99 gt data Checking programmed values lt stop RUN _ units Always check the display to make sure that you have clock 4 ERROR P bolus i COCK 4 ERROR P DOUS programmed the desired values basal lt LLELAE _temp ai H TRONplus Reference Manual 1 5 2 3 Operating status STOP RUN The operating status of the H TRONplus may be either STOP or RUN In RUN the word RUN appears in the display and the pump delivers insulin In STOP the word STOP appears in the display and the pump does not deliver insulin Operations can only be performed if the H TRONplus is in the correct operating status The H TRONplus has the following basic and special functions You will find detailed instructions for these functions on the pages indicated below Basic functions Operating Status Page Set the clock STOP 27 Program and review the basal rates STOP 2
49. e manual 66 immediate action If the pump alarms with an error code the pump 07 System Alarm sales ae a eee ay Displays ERROR and a two digit ERROR code and beeps continuously einsert batteries set clock check basal rates 8X Technical Inspection Alert Silence alarm 68 The beeping can be silenced by pressing S and holding for three seconds The alarm Schedule technical inspection message will clear from the display when the ERROR is corrected or when S is pressed 09 Technical Inspection Due Silence alarm 69 again Schedule technical inspection Begin alternate insulin delivery method 10 Cartridge Low Warning Silence alarm Insert new cartridge soon 70 11 End of Temporary Basal Rate Silence alarm 71 58 H TRONplus Reference Manual H TRONplus Reference Manual 59 7 1 Alarm ERROR 01 Empty Cartridge If the calculated according to the insulin remaining counter insulin remaining in the cartridges reaches 0 0 the pump alarms and displays ERROR 01 The word STOP appears and the pump beeps continuously The cartridge must be changed now Do the following Silence alarm by holding S for three seconds Change the cartridge and the infusion set Reset for new cartridge Prime the infusion set and change the pump to RUN 7 2 Alarm ERROR 02 Low Motor Battery 2 When the voltage of the battery in compartment 2 reaches a low level the alarm ERROR 02 appears in the display and the pump beeps co
50. e seconds after the last button is pressed the pump returns to the basal rate total Check the basal rate total to ensure it is correct Twelve seconds after the basal rate total is displayed the pump returns to the default STOP display 3 4 3 Change basal rates Any hourly basal rate can be changed without affecting the other basal rates To change basal rates the H TRONplus must be in STOP If during programming no button is pressed for 12 seconds the cursor returns to basal Twelve seconds later the pump returns to the default STOP display 1 gt Press S until the cursor points to basal The display shows Pr U basal rate programming is unlocked and allows basal rate changes Pr L will be displayed if the basal rate programming is locked Refer to section 6 5 basal rate lock unlock for more information Pr U must be displayed in order to change the basal rate programming H TRONplus Reference Manual 31 Basal rate total amount of insulin delivered by the basal rates over 24 hours 00 01 2 gt Within 12 seconds press and HOLD S The display p units scrolls through the hours without changing the basal P rates Release S when the hour to be changed is reached basal 0 6 j Within 12 seconds change the basal rate using h or m n 3 Twelve seconds after the last button is pressed the pump Pe U returns to the basal rate total Check the basal rate tot
51. ean n or replace the piston rod T 21 gt Insert the nylon end cap into the cartridge plunger Push the nylon end cap until it is snugly in place DO NOT TRY TO TWIST OR 4 TIGHTEN B 22 gt Spin the cog wheel until it reaches the bottom of the cartridge Turn the cog wheel back away from the bottom of the cartridge Q 4 turn to loosen it slightly i The cartridge and piston rod are now ready for the infusion set to be attached 4 1 4 Attach the infusion set and insert the cartridge into the cartridge compartment Steps 23 to 30 23 gt Get everything ready filled cartridge with plastic protective cap and threaded piston rod pump adapter with intact O ring infusion set H TRONplus Reference Manual 37 24 gt Snap the pump adapter onto the cartridge over the protective cap e 25 gt Remove the protective cap from the cartridge 6 protective cap from the luer lock of the infusion set Do not touch the areas previously covered by the protective caps as AN these are sterile areas l 26 gt Screw the luer lock of the infusion set clockwise into the J threads of the pump adapter 27 gt Set the pump on its end or hold it vertically 28 gt Insert the cartridge with the piston rod and pump adapter with infusion set attached into the cartridge compartment If necessary rotate the cartridge slowly until it and the piston rod drop into the ment
52. ed instructions 7 5 Alarm ERROR 05 Bolus Limit Reached Read instruction manual before using Rx only concerning Alarms ERROR in section 7 7 6 Alarm ERROR 06 Automatic off 7 7 Alarm ERROR 07 System Alarm 7 8 Alarm ERROR 8x Technical Inspection Alert No Meaning of the ERROR What you have to do Page oe Aa i sh pera Ee Waina 01 Empty Cartridge Silence alarm Insert new cartridge 60 7 11 Alarm ERROR 11 End of Temporary Basal Rate Change infusion set 02 Low Motor Battery 2 Silence alarm 60 f Warning The H TRONplus contains a safety system that constantly analyzes Replace motor battery the pump The H TRONplus ERROR messages indicate an important change of 03 Low Electronic Battery 3 Silence alarm 61 the operating status or irregularities in insulin administration The pump will Replace electronic battery be set to STOP immediately when the ERROR message appears or shortly p after Except ERROR 11 Insulin administration will be stopped In order to 04 Occlusion Silence alarm 62 maintain insulin administration you need to act immediately according to the Check blood glucose value instructions given for each ERROR code Change infusion set or check piston rod or check pump The H TRONplus Insulin Pump has an internal analysis and alarm system to protect you 05 Bolus Limit Reached Silence alarm See manual 65 The dual microprocessors detect certain conditions that are not harmful but require 06 Automatic Off Silence alan Se
53. efore and or after an operation basal 98888 gt temp This symbol represents the audible beeps All inputs are shown on E the display and are followed by one or several short and or long MM beeps 3 1 Insert and change batteries Caution In order to prevent water from entering the pump case Change pump batteries only in a dry environment When changing a battery check that the black O ring is correctly installed and seated properly Caution Removing both batteries simultaneously will cause the data memory to be erased including current settings such as temporary basal rate changes or programmed bolus the loss of the remaining cartridge volu me the history of alarms ERROR 10 and ERROR 01 and the time setting Only the basal rate programming is not lost Reinsert the batteries according to section 3 1 1 insert the batteries after having removed them simultane ously You need to reprogram verify all pump settings and start with a new cartridge If not your insulin remaining counter will not match the actual con tents of your cartridge If the cartridge in the pump actually has less than 315 0 units the cartridge low warning alarm ERROR 10 will not alert you when the cartridge is low on insulin When the cartridge is empty the pump will alarm ERROR 04 occlusion 22 H TRONplus Reference Manual The compartments for the batteries are marked as follows compartment for the motor
54. eps Immediately after the confirmation beeps the pump chan ges to RUN The display shows the temporary basal rate increase percentage on the bottom line For example 1 10 means 110 of the original basal rate will be delivered a 10 increase 52 H TRONplus Reference Manual Notes A temporary basal rate increase lasts 12 hours standard setting see section 2 4 programmable settings unless programmed otherwise The pump beeps three times on the hour each hour as a reminder If the beeps have been turned off the pump will NOT beep three times on the hour as a reminder The basal rate can be increased up to 200 twice the original basal rate The display shows 2 00 to indicate that it is programm ed for 200 of the original basal rate An incorrect entry can be corrected before the confirmation beeps by pressing m The basal level is returned to 1 00 100 of original basal rate The temporary increase can be canceled by changing from RUN to STOP The alarm ERROR 11 confirms the cancellation Silence the alarm by pressing and holding S for three seconds Then either re program a new temporary basal rate increase or change from STOP to RUN The delivery of a bolus does not interrupt the temporary basal rate increase After the 12 hour temporary basal rate increase standard setting the pump automatically returns to the original basal rate The pump alarms ERROR 11 and beeps continuously to confirm the end
55. es according to section 3 1 insert and change batteries If the display illuminates then set the clock See section 3 3 check the basal rate program See section 3 5 change the pump to RUN See section 5 1 If the pump alarms an ERROR 07 or 03 then insert a new battery in compartment 3 electronic according chapter 3 1 insert and change batteries If the display illuminates then insert a new battery in compartment 2 motor according to section 3 1 insert and change batteries set the clock See section 3 3 check the basal rate program See section 3 5 change the pump to RUN See section 5 1 72 H TRONplus Reference Manual If the pump alarms an ERROR 07 or 03 again and or the display does not illuminate then change to your back up insulin delivery device Call Disetronic at 1 800 688 4578 8 2 Incomplete full segment display insert batteries Insert a battery according to section 3 1 insert and change batteries If the segment display is incomplete after inserting the first battery into the compart ment 3 electronic then remove the battery press S and hold for three seconds insert a NEW battery according to the instructions in chapter 3 1 insert batteries Caution For preventing water from entering the pump case Change pump batteries only in a dry environment When changing a battery check that the black O ring is correctly
56. ght be unable to hear the beeps i e noise This is the only way you will be aware of any changes in the pump in a timely manner Changing to another pump Caution Prior to use always check the settings of a replacement a spare or a new pump in order to avoid a wrong dosage Cleaning I Caution Do not clean with water Do not use any solvents or strong deter gents for cleaning Only use a soft dry cloth Cosmetics soaps lotions deodorants Caution Avoid any contact of the infusion set and especially of the connect ing parts of the pump with antiseptics antibiotic creams soaps perfumes g deodorants body lotions or any other cosmetics They may cause damage to these parts Insurance Your new insulin pump is an expensive medical device We strongly encourage l you to add your pump to your homeowner s insurance policy to protect you in case of accidential damage or loss Ask your insurance agent for details Please keep these safety instructions in mind For additional questions please contact your health care team and or Disetronic For further recommendations for daily use see section 9 special situations 1 2 H TRONplus Reference Manual 2 Description and functions of the H TRONplus This section includes 2 1 Safety and warning installations of the H TRONplus 2 2 Handling and display 2 3 Operating status STOP RUN 2 4 Programmable settings 2 5 Accessories and disposables The Disetronic H TRONplus is
57. glycemia Temporary basal rate too high Re evaluate percentage of basal adjust ment for the level of activity Consult health care team Increased absorption Do not wear the pump in hot tubs saunas baths showers or when swimming Hot tubs saunas long hot baths or exer cising a limb where an infusion site is located all may cause an increase in insu lin absorption Make adjustments for this or avoid these activities H TRONplus Reference Manual 71 Troubleshooting low blood glucose hypoglycemia gt continued Pump Infusion set causes Suggested action Incorrect pump programming or basal rates not matched with needs Make sure to review basal rate changes after they are made Check with your health care team about possible rate adjustment Incorrect clock setting The correct basal rate for a time period may not be delivered if the clock is not set correctly Check the clock on a regular basis and whenever battery s are re placed Priming the infusion set while it is inserted in the body Priming will automatically deliver 25 units of insulin from the cartridge Never prime with infusion set connected to your body you risk unintended delivery of insulin Disconnecting infusion set from luer lock end while set is inserted in the body When changing the cartridge or infusion set disconnect at the site disconnecting at the luer adapter end may cause unin te
58. hin eight seconds press and hold either h or m 4 4 until the pump beeps twice 3 gt Then immediately press h and m at the same time 4 and release The display scrolls from 0 to 9 Pump self check When the scrolling is complete a long beep sounds 150 0 appears and the cursor points to data 4 5 Prime the infusion set AN JN status STOP Warning Never carry out the function priming the infusion set with an infusion set inserted in an infusion site Otherwise you risk an uncon trolled delivery of insulin into your body With disconnectable infusion sets be sure you have disconnected prior to programming changing or priming Warning Air bubbles in the infusion set cause the infusion of air instead of insulin Your body will not receive the required amount of insulin An occlusion ERROR 04 may be delayed Remove these bubbles according to the instructions while priming the infusion set Caution Only use infusion sets which are designed expressly for use with Disetronic pumps Other infusion sets may not have been checked for compatibility with Disetronic pumps and may therefore endanger your health if used Always have extra infusion sets with you This will allow you to exchange components when needed The infusion sets are sterile products intended for single use only Sterility is guaranteed for unopened packaging up to the indicated expiration date Do not use if package is da
59. ice Call Disetronic at 1 800 688 4578 Caution For preventing water from entering the pump case Change pump batteries only in a dry environment When changing a battery check that the black O ring is correctly installed and seated properly 8 4 Therapy situations Caution Do not use these procedures without approval of your health care e team Always follow your health care team s recommendations This section describes some potential situations and some possible solutions occasion ally reported by insulin pump users These categories include High blood glucose values Hyperglycemia Low blood glucose values Hypoglycemia These are only suggestions always check with your health care team 74 H TRONplus Reference Manual Troubleshooting high blood glucose hyperglycemia Insulin Causes Suggested Actions Poor absorption Choose infusion sites without scar tissue bruises or tissue buildup Do not use any infusion set site longer than recommend ed Mismatch of insulin with food Check pump memory for bolus amount and re evaluate Consult health care team for adjustment of insulin to carbohydrate ratio if necessary Forgotten meal bolus or bolus taken too long after a meal Check pump memory to confirm missing bolus Time the meal bolus according to the onset of insulin action or according to your health care team s recommenda tions Ineffective or expired in
60. ime 6 gt Remove protective needle cover Ensure that nothing touches the needle 7 gt Move the plunger back and forth in the cartridge two times to distribute the lubricant Pull the plunger back to the 3 15 mark of the plastic cartridge or the bottom edge of the glass cartridge to fill the cartridge with air H TRONplus Reference Manual 35 4 1 2 Fill the cartridge Steps 8 to 17 Move the plunger rod slowly and steadily when filling the cartridge Do not move the plunger rod side to side when filling the cartridge the seal between the plunger and the inside of the cartridge may break gt Set the bottle of insulin on a hard surface like a table yt 9 gt Wipe bottle top with an alcohol wipe ved 10 gt Push the tip of the filling needle down into the insulin bottle y Push the plunger rod down so that all air from the cartridge enters 2 the insulin bottle Make sure that the tip of the needle does not SS contact the insulin while air is pushed into the insulin bottle ij Il 11 gt While holding steady pressure against the plunger rod with Q your thumb invert the bottle so that the filling needle and cartridge are pointing upwards into the insulin bottle Remove your thumb from the plunger rod Insulin will begin to fill the cartridge Do not pull on the plunger rod while it is moving Make sure that the tip of the filling needle stays in the insulin during the entire filling procedure 12 gt Slowly pul
61. l the plunger rod in a straight line and completely fill the cartridge Be careful not to move the plunger rod side to side Caution Remove any air bubbles by tapping on the cartridge to dislodge them Push them back into the insulin bottle with the plunger rod 13 gt The cartridge is full when the top of the plunger of the plastic cart a ridge is even with the 3 15 marker line or when the bottom edge of the plunger of the glass cartridge is even with the bottom edge of the A y glass cartridge a 14 gt Remove the filling needle and the cartridge from the insulin bottle Put the protective needle cover on the filling needle 36 H TRONplus Reference Manual 15 gt Remove the filling needle and protective cover from the cartridge 16 gt Push the cartridge protective cap TIGHTLY onto the cartridge until it is snug 17 gt Remove the plunger rod by turning it counterclockwise out of the plunger Take care not to move the plunger during removal The cartridge is now ready for the insertion of the piston rod 4 1 3 Insert the piston rod into the cartridge Steps 18 to 22 el 18 gt Ensure that the cartridge protective cap is on the cartridge and Pais TIGHTLY in place _ 19 gt Spin the nylon end cap If the nylon end cap does not spin fa freely replace the piston rod 20 gt Spin the cog wheel to a position that is more than half way down from the end cap If the cog wheel does not spin freely cl
62. le time off the pump and for an off pump injection regimen Incorrect pump programming or basal rates not matched with needs Always review any changes made in basal rate programming Check with health care team about possible rate adjustment 76 H TRONplus Reference Manual Troubleshooting high blood glucose hyperglycemia gt continued Other Causes Suggested Action Decreased activity illness or stress Additional medication other than insulin Check with health care team about using temporary basal rate increase Some medications other than insulin may affect blood glucose Check with your pharmacist or doctor if your medications may have this effect and ask how to adjust rates accordingly Rebound from low BG or Dawn phenomenon rise in glucose in early morning hours Consult health care team to re evaluate blood glucose control and overnight pump settings Troubleshooting low blood glucose hypoglycemia Insulin Causes Suggested Action Bolus dose too high for amount of food eaten Check pump memory for amount given and re evaluate also may need to consult health care team to adjust insulin to carbohydrate ratio Alcohol consumption Be sure to eat when consuming alcohol increase blood glucose monitoring as hypoglycemia may occur much later Basal rates too high Call health care team for basal adjust ment if cannot skip a meal without hypo
63. lectronic according to section 3 1 insert and change batteries Leave the compartment 2 motor empty If the 86 H TRONplus Reference Manual 3 display does not illuminate discard the battery If the display illuminates then Press h or m The display should scroll through the self check num bers 0 to 9 If not discard the battery If the battery passes the self check then The pump will show an alarm If the pump alarms low electronic battery ERROR 03 discard the battery If the pump alarms low motor battery ERROR 02 silence the alarm and keep the battery 10 5 Your pump checklist Check your insulin pump at least daily Make sure that the batteries are inserted properly so that the top of the battery is level with the pump case the basal rates are set correctly according to your health care team s recommendation the clock is accurately set the piston rod is properly inserted the cartridge and infusion set are free of air bubbles the pump adapter is tight visually inspect the cartridge and compare the actual amount of insulin to the calculated amount on the insulin remaining counter the infusion set is primed free of air bubbles and is tight on the pump adapter the infusion set is inserted according to manufacturer s instructions the pump is in RUN the infusion site is secure comfortable and free of irritation the pump case is free of chips or cracks buttons are free of tears or
64. lin Pump is in the STOP display there is no insulin being delivered To inform you that no insulin is being administered the pump gives a long beep STOP Alarm every minute When the pump beeps the display shows STOP and illuminates for 30 seconds Controlling the STOP Alarm will suppress this warning function Do not silence the STOP Alarm unless the pump is not used for several hours To silence the STOP Alarm the pump must be in STOP If during programming no button is pressed for eight seconds the pump returns to the default STOP display 1 gt Press S until the cursor points to clock 2 gt Within eight seconds press h and m at the same time brie fly The pump beeps when the buttons are pressed 3 gt Immediately again press h and m at the same time briefly The STOP alarm has been silenced when the cursor points to data All other beeps and alarms are still active When the pump is changed to RUN the STOP Alarm is restored When the pump is changed to STOP again the STOP Alarm will sound 56 H TRONplus Reference Manual 6 5 Basal rate lock unlock status STOP The basal rate program can be locked or unlocked When it is locked the basal rates cannot be changed When it is unlocked the basal rates can be changed To lock the basal rates the pump must be in STOP If during programming no button is pressed for 12 seconds the pump returns to the default STOP display Pr U C H 4 Pre
65. lows C compartment for the motor battery 2 for ERROR 02 compartment for the electronic battery 3 for ERROR 03 Electronic 3 farthest from the cartridge chamber Always have extra batteries available and pay attention to the following Do not store the batteries in the refrigerator or freezer High humid ity affects battery life Prevent early discharge of the batteries by preventing contact bet ween the batteries themselves and between the batteries and any other metal coins keys etc Always keep batteries in the original package until ready to use For operating the pump the temperature of the batteries must be 41 F to 122 F 45 C to 50 C 1 8 H TRONplus Reference Manual To tighten batteries use only the Disetronic battery tool until the top of the battery is level with the pump case Over tightening may cause pump case damage Use only Disetronic batteries Otherwise the settings and alarms may be incorrect and or the pump could be damaged The working life of the batteries 2 and 3 is affected by usage of the pump rates temp erature etc Batteries should last at least 4 weeks Caution For preventing water from entering the pump case l Change pump batteries only in a dry environment When changing a battery check that the black O ring is correctly installed and seated properly Battery tool og Use only the battery tool to insert tigh
66. maged Do not reuse single use materials Reuse of single use materials might lead to an infection and or to a malfunction of the pump and to the administration of an incorrect amount of insulin 42 H TRONplus Reference Manual Prime the infusion set The H TRONplus will prime 20 units of insulin at a time If insulin is not dripping from the infusion set needle at the end of the prime repeat the prime When insulin drips from the end of the needle press any button to stop the prime An infusion set is filled when air is eliminated from the set and insulin drips from the end of the needle If during programming no button is pressed for eight seconds the pump returns to the default STOP display we te ee 1 gt Press S until the cursor points to prime ae ib q3 2 gt Within eight seconds press h and m and S at the same time and release The pump begins priming 2U 0 3 gt Hold the pump vertically while priming to help send any air to the top of the cartridge for elimination during 4 6545 gt data priming The prime can be stopped at any time by pressing ANY 314 9 button 4 6 Select and prepare an infusion site The insulin remaining on the lower line of the display decreases as the priming continues The pump displays two cursors one at prime and one at data becau se the insulin remaining is decreasing when the prime is complete the pump beeps and returns to the default ST
67. mp is reset to a full cartridge volume and displays 315 0 units If the cartridge in the pump actually has less than 315 0 units the cartridge low warning alarm ERROR 10 will not alert you when the cartridge is low on insulin When the cartridge is empty the pump will alarm ERROR 04 occlusion The clock is reset to 00 00 hours The clock must be reprogrammed to the correct time before restarting the pump Failure to reset the clock may result in incorrect basal insulin delivery 26 H TRONplus Reference Manual 3 3 Set the clock status STOP The H TRONplus uses a 24 hour military time clock To help in using a 24 hour clock the table below shows the conversion from a 12 hour clock to a 24 hour clock 12 hour clock vs 24 hour clock 12 hour clock 24 hour clock 12 hour clock 24 hour clock 1 00 AM 01 00 1 00 PM 13 00 2 00 AM 02 00 2 00 PM 14 00 3 00 AM 03 00 3 00 PM 15 00 4 00 AM 04 00 4 00 PM 16 00 5 00 AM 05 00 5 00 PM 17 00 6 00 AM 06 00 6 00 PM 18 00 7 00 AM 07 00 7 00 PM 19 00 8 00 AM 08 00 8 00 PM 20 00 9 00 AM 09 00 9 00 PM 21 00 10 00 AM 10 00 10 00 PM 22 00 11 00 AM 11 00 11 00 PM 23 00 12 00 PM 12 00 12 00 AM 24 00 Example If the time is now 1 39 PM the 24 hour time is 13 39 Example If the time is now 6 15 PM the 24 hour time is 18 15 Example If the time is now 8 30 AM the 24 hour time is 08 30 To set the clock the Disetronic H TRONplus
68. must be in STOP If during programming no button is pressed for eight seconds the pump returns automatically to the default STOP display H TRONplus Reference Manual 27 1 gt Press the S button 3 times or until the cursor points to clock clock Setting the hours 2 gt Within 8 seconds press h to set the hours The h symbol represents hours Setting the minutes 3 gt Within eight seconds after the last press of the h button press m to set the minutes The m symbol represents minutes Optional scrolling If h or m is held down the display advances five numbers and then scrolls numbers quickly Hold h or m until the desired hour or minute is reached 1 Hg data Eight seconds after the clock is set the time is automatically entered into memory by the pump The cursor returns to data the pump emits a long beep Il and displays the time Note If you do not wait for the long beep IEE after setting the clock and try to put the pump in RUN you will inadvertently turn off the beeps Instructions on how to control the beeps are in section 6 3 Instructions on how to control the STOP Alarm are in section 6 4 3 4 Program the basal rates status STOP Warning Incorrect programming of the pump will lead to an incorrect N dose of insulin Do not operate the H TRONplus Insulin Pump without knowing your personal settings The pump must be programmed with your personal set tings prior to sta
69. n twelve seconds the pump returns to the default display 6 1 1 Recall insulin remaining To recall the insulin remaining the pump must be in RUN gt Press S until the cursor points to data Caution The indication of the cartridge volume on the display is a calculated value When a new cartridge full or half filled is inserted the pump must be reset for a full or half filled cartridge otherwise the displayed value of the remaining amount of insulin is incorrect 6 1 2 Recall total amount of insulin since midnight To recall the total amount of insulin infused since midnight the pump must be in RUN gt Press S until cursors point to RUND units units gt bolus bolus temp temp The total amount of insulin is displayed next to temp this total is rounded to the nearest whole unit 6 1 3 Recall recent boluses The H TRONplus memory stores information on the last 10 boluses If the pump has not delivered 10 boluses since both batteries were inserted at the same time the pump will only display the boluses that have been delivered 50 H TRONplus Reference Manual To recall bolus information the pump must be in RUN 1 gt Press S until the cursor points to bo us The display alternately flashes 01 and the time of the last bolus on the top line 01 means the last bolus The bolus amount is on the bottom line If S is not pressed again within 12 seconds
70. nately flashes 02 and the time of the second most recent alarm 02 means the second most recent alarm The ERROR code is on the bottom line If S is not pressed within 12 seconds the pump returns to the default RUN display 3 gt Press S repeatedly to recall remaining alarms ERROR codes and times are recalled in sequence 03 04 etc If S is not pressed within 12 seconds the pump returns to the default RUN display If planning to remove both batteries record any data memory information that will be needed later as inserting both batteries will lead to a reset of the data memory 6 2 Set temporary basal rate status STOP 6 2 1 Set temporary basal rate increase To set a temporary basal rate increase the pump must be in STOP If during pro gramming no button is pressed for eight seconds the pump returns to the default STOP display 13 46 STOP OU 1J G Een po E U Ce mS Vv j temp temp 1 gt Press h until the cursor points to temp The display shows 1 00 to indicate that it is programmed for 100 of the original basal rate 2 gt Within eight seconds repeatedly press h to increase the basal rate by 10 increments to the desired level Eight seconds after the last button is pressed the pump beeps TWICE for each time h was pressed These are con firmation beeps If the beeps have been turned off the pump will NOT give confirmation be
71. nded delivery of insulin Other Causes Suggested Action Increased physical activity Most people need less insulin when more active Check with your health care team about reducing insulin for increased activity using the temporary basal rate decrease Medication other than insulin Some medications other than insulin may affect blood glucose Check with your pharmacist or doctor if your medications may have this effect and ask how to adjust rates accordingly 78 H TRONplus Reference Manual 0 ee This section includes 9 1 Recommendations for daily use 9 2 Interruption of pump therapy 9 3 Use of a partially filled cartridge plastic cartridges only 9 1 Recommendations for daily use Training and use of the pump requires support of an experienced trainer and health care team Regular visits with your health care team are absolutely essential in pump therapy Always follow the instructions given by your health care team Only change your personal settings after consulting your health care team Successful pump therapy requires frequent self monitoring of blood glucose values at least 4 times a day or as directed by your health care team Traveling Ask your health care team about any special precautions needed prior to your trip Make sure you bring extra supplies Also make sure you know places where you can obtain supplies should this become necessary 9 2 Interruption of pump therapy Consult
72. new infusion set prime and reconnect after ensuring that insulin drips from the end of the connector needle and there is no air in the system Change the pump to RUN If the pump alarms ERROR 04 go to step 6 H TRONplus Reference Manual 63 6 gt Remove cartridge with piston rod and replace with new cartridge and new piston rod if available Insert new cartridge with piston rod reset the pump for a new cartridge attach a new infu sion set and prime If the pump does not alarm ERROR 04 change the pump to RUN Reconnect the infusion set to the site after making sure that insulin is dripping from the connector needle and there is no air in the system If the pump alarms ERROR 04 go to step 7 7 gt Change to your back up insulin delivery device or contact your health care team for an alternate insulin therapy plan Call Disetronic at 1 800 688 4578 With a non disconnect infusion set do the following 1 gt Press S and hold for three seconds to silence the alarm ERROR 04 stays on the display 2 gt Check blood glucose value If elevated treat according to your health care team s instructions Go to step 3 3 gt Remove the infusion set from the site Prime If the pump does not alarm ERROR 04 and insulin drips from the needle at the end of the infusion set remove the infusion set from the adapter Screw new infusion set onto adapter Prime Insert the infusion set into a newly prepared infu
73. ng water from entering the pump case Change pump batteries only in a dry environment When changing a battery check that the black O ring is correctly in stalled and seated properly 7 3 Alarm ERROR 03 Low Electronic Battery 3 When the voltage of the battery in compartment 3 reaches a low level the alarm ERROR 03 appears in the display and the pump beeps continuously The pump checks the voltage of the electronic battery every hour every time the pump delivers insulin and every time the pump is switched from STOP to RUN Do the following Silence alarm by holding S for three seconds Check the display If it shows a Ce gt gt STOP try to change to RUN If no alarm sounds and the display shows RUN do not change the battery gt STOP and will NOT change to RUN and alarms again 2 ERROR 03 change the battery Change the pump to RUN tJ H TRONplus Reference Manual 61 gt RUN press S to clear the display Do not change the battery unless the alarm ERROR 03 will not clear Be sure that the battery is tight and correctly inserted and has an intact O ring according to section 3 1 insert and change bat teries Note The pump may operate for a period of time even when the voltage is low The pump will continue to deliver insulin and may alarm every hour until the battery voltage drops to a level which triggers continuous beeping and the alarm ERROR 03 will not clear
74. nsert remove the batteries Chim gt activates the time to technical inspection Prime infusion set prime D o basal rate temp Recall data memory counter S gt h gt lm gt S gt Activate 10 increase a Activate the display Ih XY up to 200 max S gt Insulin remaining h gt m gt for one second Stop my Reset to 100 while setting 5 gt Total amount of insulin Silence ot ci an a Reset a new cartridge reset since midnight BOLEE PES Temporary basal rate a s gt until a long beep sounds S gt h gt m gt Start the selftest m gt apie 7 temp 10 loweri IS gt gt gt Recent boluses max 10 to clear from display m 0 owenng s gt press S briefly Set the clock clock Gown to 0 D Reset to 100 SD Al 5 shy Hours 00 24 while setting alin Messages max im gt gt gt Minutes 00 59 Legend h gt Control the beeps STOP cancel Confirmation beeps Control the while delivering the bolus RUN delivering the bolus Press as m gt STOP Alarm i button Program a bolus Program the basal rates basal Press button several times Eada Activate lt hl o to the next hour IS YY Review basal rate Input of the bolus volume 1 bolus step pressin Khl Press Press p p g button a bution together ih gt gt Increase the rate rl units Reset to 0 0 lt m Press the buttons within 8 seconds mY Lower the rate Adate Gal otherwise the pump will quit the Copy the same rate
75. nsists of 24 hourly basal rates Usually unique for each insulin pump user Pump adapter A cylindrical object that screws into the cartridge compartment to hold the cartridge in place An infusion set is screwed into the pump adapter The adapter has two holes for air pressure compensation Reset A process that resets the insulin remaining counter for a new full or half full cartridge H TRONplus Reference Manual 93 Status operating status A condition of insulin pump operation either RUN when insulin is being delivered or STOP when insulin is not being delivered Subcutaneous A term that means beneath the skin The infusion set needle is inserted sub cutaneously Temporary basal rate The programmed basal rate can be temporarily increased or decreased to adjust insulin for special situations such as for changes in activity or illness that may require more or less insulin The pump automatically returns to deliver the programmed rate after a specified time Total amount of insulin delivered since midnight An information display data memory that indicates the total amount of insulin delivered since midnight The total includes all basal rate delivery all boluses and any temporary basal rate changes that have occurred This amount does not include any volume from the prime function 94 H TRONplus Reference Manual A Accessories 2 0 e eee 10 18 Adapter occ i cnc ens 20 84 93 Air bubbles 9
76. ntinuously The pump checks the voltage of the motor battery every hour every time the pump delivers insulin and every time the pump is switched from STOP to RUN Do the following g Silence alarm by holding S for three seconds Check the display If it shows gt STOP try to change to RUN If no alarm sounds and the display shows RUN do not change the battery gt STOP and will NOT change to RUN and alarms again o ERROR 02 change the battery Change the pump to RUN gt RUN press S to clear the display Do not change the bat tery unless the alarm ERROR 02 will not clear Be sure that the battery is correctly inserted and has an intact O ring according to section 3 1 insert and change batteries 60 H TRONplus Reference Manual Note The pump may operate for a period of time even when the voltage is low The pump will continue to deliver insulin and may alarm every hour until the battery voltage drops to a level which triggers continuous beeping and the alarm ERROR 02 will not clear When the alarm ERROR 02 will not clear and the pump will not change to RUN change the battery immediately Do not remove both batteries at the same time after a battery alarm in order to keep the data memory Change only the battery in compartment 2 when the pump alarms ERROR 02 Always keep extra batteries immediately available Keep batteries in their original package Caution For preventi
77. o week intervals When the pump has been in use for a total of 24 months it changes to STOP and alarms tech nical inspection due ERROR 09 82 H TRONplus Reference Manual Schedule the technical inspection with Disetronic Technical Service Technical Service Disetronic Medical Systems Inc 5151 Program Avenue St Paul MN 55112 1014 USA Phone 1 800 688 4578 The 24 months of use is calculated by the pump based on the length of time that the batteries are in the pump The time when the batteries are removed is not counted 10 2 Maintenance and cleaning For best operation of the pump pay attention to the following items 10 2 1 System check Only a well maintained system guarantees an accurate dose of insulin Check the insulin pump the cartridge the adapter the infusion set and the infusion site regularly Replace and discard these items according to the instructions of your health care team and according to the specifications in the corresponding user instructions Use only specified accessories and disposables 10 2 2 Insulin pump Inspect the pump case daily for cracks or chips Check the blue button covers and the S button for damage Be sure that the buttons rebound when pressed Check the display window for any cracks or blank spots that would indicate poor condition If the insulin pump had contact with water then immediately dry it well with a soft dry cloth H TRONplus Reference Manual 83 Caution Do n
78. of the temporary basal rate increase The pump remains in RUN Silence the alarm by pressing S for three seconds Press S again to clear the alarm message from the display 6 2 2 Set temporary basal rate decrease Warning If a basal rate decrease is programmed to a value of 0 no insulin will be delivered for four hours standard setting To set a temporary basal rate decrease the pump must be in STOP If during programming no button is pressed for eight seconds the pump returns to the default STOP display H TRONplus Reference Manual 53 Jy cs 0 1 gt Press m until the cursor points to temp The display shows E 1 00 to indicate that it is programmed for 100 of the original 1 gt temp basal rate 2 gt Within eight seconds repeatedly press m to decrease the basal rate by 10 increments to the desired level 13 49 Eight seconds after the last button is pressed the pump beeps RUN ONCE for each time m was pressed These are confirmation TEN beeps If the beeps have been turned off the pump will NOT U bu gt jteme give confirmation beeps Immediately after the confirmation beeps the pump changes to RUN The display shows the temporary basal rate decrease per centage on the bottom line For example 0 90 means 90 of the original basal rate will be delivered a 10 reduction Notes A temporary basal rate decrease lasts 4 hours standard setting see section 2 4 programma
79. onal tool designed to facilitate the filling of glass or plastic cartridges 4 3 1 Prepare the cartridge Steps 1 to 7 1 gt Get everything ready EasyFill New cartridge and plunger rod New cartridge protective cap New filling needle with protective cover Insulin at room temperature to minimize formation of air bubbles 2 gt Wash your hands 3 gt Remove the cartridge with plunger rod and protective cap from blister pack ina j 4 gt Remove filling needle with protective cover from blister pack Be careful not to touch the open end of the filling needle or eY cartridge tip as they are sterile S 5 gt Place filling needle with cover on cartridge tip and tighten D AO Tighten it by pressing and turning at the same time _ lt i 6 gt Insert the cartridge with the filling needle into the EasyFill The y bottom edge of the cartridge should be level with the clamping disk of the EasyFill Press the cartridge firmly into place until it snaps 7 gt Move the plunger back and forth in the cartridge two times to distribute the lubricant Pull the plunger back to fill the cartridge with air H TRONplus Reference Manual 39 4 3 2 Fill the cartridge using the EasyFill Steps 8 to 15 9 gt Wipe the bottle top with an alcohol wipe as 10 gt Remove protective needle cover Ensure that nothing touches 4 the needle 11 gt Push the bottle holder of the EasyFill onto the top of
80. ot clean with water Do not use any solvents or strong detergents for cleaning and avoid any contact of the case with perfumes or deodorants Use only a soft dry cloth to clean the pump and the cartridge compartment for example if insulin leaked into the compartment If the compartment is too dirty to be cleaned with a dry cloth then send the pump to Disetronic Technical Service for cleaning Send your pump to Disetronic Technical Service for a technical inspection when it is scheduled 10 2 3 Piston rod The piston rod moves the plunger forward in the cartridge Ensure that the cog wheel spins freely on the piston rod The nylon end cap should spin freely and the metal rod should be clean Replace the piston rod when worn when the nylon end cap becomes loose broken or does not spin when the cog wheel does not spin freely and yearly A dirty piston rod for example with crystallized insulin on it may cause an occlusion alarm ERROR 04 10 2 4 Pump adapter The pump adapter provides a reliable connection between the pump cartridge and the infusion set Inspect the O rings before putting the pump adapter on the pump They should not show signs of wear The two small openings on the adapter allows air pressure to equalize Keep them open and clean 84 H TRONplus Reference Manual Replace the pump adapter when the O rings are worn damaged or missing when the openings are blocked and after
81. our pump for trouble shooting help or to make arrangements to return your H TRONplus for inspection Always dry your pump with a dry cloth after accidential contact with water Change pump batteries only in a dry environment When changing a battery check that the black O ring is correct ly installed and seated properly A Warning Incorrect programming of the pump will lead to an incorrect dose of insulin Do not operate the H TRONplus Insulin Pump without knowing your personal settings The pump must be programmed with your personal settings prior to starting the therapy If you are not experienced make sure that your doctor or health care professional checks your personal settings Frequent self blood glucose monitoring will help you to find your personal settings more rapidly and to detect incorrect doses early Successful pump therapy requires at least 4 measurements of blood glucose per day or as directed by your health care team Since only fast acting insulin is used for pump therapy there is no insulin reserve in the body Without insulin diabetic ketoacidosis can develop rapidly leading to hospitaliza tion If insulin delivery is interrupted for any reason be prepared to replace the missed insulin immediately Make sure to check your blood glucose regularly to determine if the system is functioning properly 8 H TRONplus Reference Manual Warning If an alarm occlusion ERROR 04 appears immediatel
82. ow Electronic Battery 3 09 Technical Inspection Due 04 Occlusion 10 Cartridge Low Warning 05 Bolus Limit Reached 11 End of Temporary 06 Automatic Off Basal Rate Short explanation of the error code list shown on the back of the H TRONplus Insulin Pump Always refer to the detailed instructions DISETRONIC 1 800 688 4578 abi skh k concerning Alarms ERROR in section 7 Read instruction manual before using Rx only Programming symbols prime data _ reset units clock bolus basal temp Symbol Meaning prime prime the infusion set reset reset a new cartridge clock set the time control the beeps basal program and check the basal rate data insulin remaining recall data memory units current basal rate bolus bolus temp temporary basal rate change Quick Look at the Operating Displays prime 10 04 data prime 10 089 data reset units reset RUN gt _units clock bolus clock bolus basal temp basal g g temp STOP RUN prime reset clock basal 10 04 STOP ERROR i ERROR Page 42 41 27 55 28 50 49 29 45 46 52 data units bolus temp Short explanation of the error codes ERROR CODES omanan Short explanation of the error code list 01 Empty Cartridge i system Alarm shown on the back of the H TRONplus 02 Low Motor Battery 2 8x Technical Inspection Alert 03 Low Electronic Battery 3 09 Technical Inspection Due Insulin Pump 04 Occlusion 10 Cartridge Low Warning 05 Bolu
83. re moved them simultaneously You need to reprogram verify all pump settings and start with a new cartridge If not your insulin remaining counter will not match the actual contents of your cartridge Caution Do not try to recharge the battery Do not open the battery or dispose of it in a fire Always have extra batteries available and pay attention to the following Do not store the batteries in the refrigerator or freezer High humid ity affects battery life To store the batteries respect the following conditions Temperature 32 to 86 F 0 to 30 C Air humidity 10 to 80 Prevent early discharge of the batteries by preventing contact bet ween the batteries themselves and between the batteries and any other metal Always keep batteries in the original package until ready to use For operating the pump the temperature of the batteries must be 41 F to 122 F 5 C to 50 C To tighten batteries use only the Disetronic battery tool until the top of the battery is level with the pump case Over tightening may cause damage to the pump housing Use only Disetronic batteries If not the settings and alarms may be incorrect and or the pump may be damaged The working life of the batteries 2 and 3 is affected by usage of the pump rates temp eratures etc Batteries should last approximately 4 weeks or more Testing batteries 1 Remove both batteries from the pump Put the battery to be tested in compartment 3 e
84. rmissible air pressure range Fragile handle with care HEN foes 2 Protect against moisture 1 SN N ny E S RY AN0 Protect from heat and sunlight For single use only Does not contain pyrogen 90 H TRONplus Reference Manual Does not contain PVC w Recycling p X Do not throw away Flammable See Apparatus type BF according to standard EN 60601 1 Protection against electrical shock 3 B g b Pump case protects the pump against the effects of temporary immersion in water according to the standard IEC 60529 CE 0123 CE mark according to C 0301 European Medical Device Directive Rx only Federal law USA restricts this device to sale by or on the order of a physician Sticky tape H TRONplus Reference Manual 91 12 e Basal rate The continuous rate of insulin that is delivered in units per hour The basal rate provides coverage over a 24 hour period of time In the H TRONplus this can be programmed independently for each hour of a 24 hour period Basal rate decrease A temporary decrease in the programmed basal rate that can be programmed by the pump user Basal rate increase A temporary increase in the programmed basal rate that can be programmed by the pump user Basal rate total The total amount of insulin delivered by the basal rate over 24 hours Battery compartment Opening in the pump for the motor battery 2
85. rt of insulin pump therapy The insulin is delivered from the cartridge in the pump through the infusion set into the subcutaneous tissue The cannula is usually placed in the abdomen or the hip All infusion sets are sterile and intended for single use only Disetronic offers a wide range of infusion sets The infusion set is a sterile packed product intended for single use only Do not use if package is damaged Do not reuse single use materials All Disetronic infusion sets are PVC free They are made of polyethylene only or polyethylene covered with polyurethane thus they are well tolerated by the skin and neutral to insulin The diameter of the infusion set tubing has been reduced in order to achieve faster and more economical priming Common length of the tubing filling volume U 100 60 cm 24 10 Units 80 cm 31 13 Units 110 cm 43 18 Units Protective coverings carrying systems and other accessories Specially designed carrying systems allow you to carry the H TRONplus on or under neath your clothes Please consult the special catalogue Insulin Pump Supplies and Accessories for more information or contact Disetronic 20 H TRONplus Reference Manual 3 Set up your pump This section includes 3 1 Insert and change batteries 3 1 1 Insert the batteries 3 1 2 Change the batteries 3 2 Insert remove both batteries 3 2 1 Insert both batteries 3 2 2 Remove both batteries 3 3 Set the clock 3 4 Program the basal rate
86. rting the therapy Make sure that if you are not experienced your doctor or health care professional checks your personal settings The H TRONplus delivers insulin every three minutes 24 hours a day This flow of insulin measured in units per hour is called the basal rate and is calculated to meet your basic insulin needs The H TRONplus basal rate profile consists of 24 hourly basal rates 28 H TRONplus Reference Manual Your individual basal rates must be programmed into the pump before you start your therapy The basal rate for each hour of the day is programmed on a separate display screen Note The insulin amounts and other programming numbers used in this reference manual are only examples your programming may differ 3 4 1 Program a basal rate for each hour To program basal rates for each hour individually the H TRONplus must be in STOP If during programming no button is pressed for twelve seconds the cursor returns to basal Twelve seconds later the pump returns to the default STOP display 1 gt Press S until the cursor points to basal The display shows Pr U basal rate programming is unlocked and allows basal rate changes Pr L will be displayed if the basal rate programming is locked Refer to section 6 5 basal rate lock unlock for more information Pr U must be displayed in order to change the basal rate programming Basal rate total amount of insulin delivered
87. rtridge 60 Alarm ERROR 10 Cartridge low warning 70 Cartridge compartment 37 92 Checklist a nn nunana 87 Cleaning icc deseeete aes ees 12 83 Clock seauceatpads Ge te teiede 27 COG EEE E E 11 Control The beeps nnna 12 55 The STOP Alarm 56 D Datamemory 4 49 Disposable materials see accessories Display cick awked a aoe eed wae 14 92 Activating 14 Blank aspris sane acaws 72 Incomplete 73 H TRONplus Reference Manual 95 E B60 Pll 2 prs geawss ade E ates wxtoes 39 Electromagnetic fields 10 ERROR alarms see Alarms F Fill the cartridge see cartridge FIYIN sess ie we eet de ah eae 12 H Handling dpe each ver eacmces yat 14 PDUHON sc ossxcteieswswadiaeed 15 heat gccaies ch eenaatecwoncgne 11 hyperglycemia 005 75 hypoglycemia 2 095400 cereed 77 l Infusion Set 9 20 37 85 93 Change cn ceusielicdvadaes 47 Filling volume 20 Infusion site 43 93 INGUIN is cceebeseweieeoe ce xme 6 9 Insulin Remaining 50 Insurance 2 0 005 12 88 Intended use 00e cece 6 Interrupting the therapy 79 L Leakage kinda wthind wm i ia 9 Luer connector 93 M Maintenance 83 MDUNON i oicincn eee ween vans es 15 mobile phones 05 10 model 05 Cover page 96 H TR
88. ry by pressing h or m 5 3 Cancel a bolus status RUN 1 Before the confirmation beeps the bolus amount can be reset to 0 0 by pressing the opposite button Opposite button h or m from the button used to set the bolus 2 After the confirmation beeps the bolus can be canceled by changing the pump to STOP press and hold h and m at the same time until the display shows STOP 3 During delivery a bolus can be interrupted by changing the pump to STOP press and hold h and m at the same time until the display shows STOP l Caution The pump will not deliver any insulin while it is in STOP The amount and time of the last ten boluses can be reviewed with the recall data memory feature see section 6 1 3 recall recent boluses 5 4 Change a cartridge and an infusion set status STOP infusion set with an infusion set inserted in an infusion site Otherwise you risk an uncontrolled delivery of insulin into your body With disconnect able infusion sets be sure you have disconnected prior to programming changing or priming Warning Never change the cartridge or carry out the function priming the H TRONplus Reference Manual 47 Warning Air bubbles in the cartridge and in the infusion set cause the infusion of air instead of insulin Your body will not receive the required amount of insulin An occlusion ERROR 04 may be delayed Remove these bubbles according the instructions in section 4 1 fill the cartridg
89. s 3 4 1 Program a basal rate for each hour 3 4 2 Program the same basal rate for several hours 3 4 3 Change basal rates 3 5 Review basal rate programming Caution The pump and disposable materials should be used for the first time in the presence of your doctor or health care team Regular medical examinations are required If the pump user is not able to independently operate the H TRONplus pump e g due to a disability or other special conditions make sure that the assisting person strictly follows the instructions contained in this manual Caution Always pay attention to the operating status of the H TRONplus STOP or RUN Operations can only be performed if the H TRONplus is in the correct operating status In this reference manual you will find the necessary operating status indicated on the headline in bold type Always make sure that you are in the required operating status and change the status if required according to the instructions in the chapter 5 1 start and stop pump delivery H TRONplus Reference Manual 21 Remember these symbols for functions and operations Symbol Description lt 4 or gt A small triangle or cursor indicates the selected function gt This arrow indicates when you have to do something e g to press a button prime a 444 gt data schematic representation of the display illustrates the reset 4 STOP RUNp _ units p z s dock lar Ennon rl bolis corresponding information b
90. s Limit Reached 11 End of Temporary DerAutomencOrt eile Always refer to the detailed instruc DISETRONIC 1 800 688 4578 tions concerning Alarms ERROR in Read instruction manual before using Rx only section 7 No Meaning of the ERROR What you have to do Page 01 Empty Cartridge Silence alarm Insert new cartridge 60 Change infusion set 02 Low Motor Battery 2 Silence alarm 60 Replace motor battery 03 Low Electronic Battery 3 Silence alarm 61 Replace electronic battery 04 Occlusion Silence alarm 62 Check blood glucose value Change infusion set or check piston rod i or check pump DD DISETRONIC 05 Bolus Limit Reached Silence alarm See manual 65 06 Automatic Off Silence alarm See manual 66 07 System Alarm Remove batteries Press S for three seconds 67 R Distributed by Reinsert batteries set clock check basal rates Disetronic Medical Systems AG Disetronic Medical Systems Inc 8X Technical Inspection Alert Silence alarm 68 Kirchbergstrasse 190 5151 Program Avenue Schedule techiical inspection CH 3401 Burgdorf Switzerland St Paul MN 55112 1014 USA i Phone 41 34 424 41 11 Phone 1763 795 5200 09 Technical Inspection Due Silence alarm 69 Fax 4134 424 29 19 Toll free 1800 280 7801 F www disetronic com info disetronic usa com Begin alternate insulin delivery method a CEE RICE nan 10 Cartridge Low Warning Silence alarm Insert new cartridge soon 70 11 End of Temporary
91. s refer to this manual for questions about operating and trouble shooting the pump This user manual is written for users of the H TRONplus Insulin Pump as well as health care professionals The user manual is designed to provide you with the necessary information for safe and efficient use of the H TRONplus Insulin Pump Please refer to the instructions for use of the accessories and dispos able materials needed to operate the H TRONplus Insulin Pump For any further information please contact Disetronic Intended use of the H TRONplus Insulin Pump The H TRONplus Insulin Pump is a prescription use only product and has been developed exclusively for the continuous subcutaneous deli very of U 100 insulin for the treatment of insulin dependent diabetes mellitus Do not use the H TRONplus Insulin Pump for the administra tion of medications other than U 100 insulin Do not modify the device in any way as this could lead to malfunction Continuous Subcutaneous Insulin Infusion CSII using the H TRONplus Insulin Pump You must be trained by your doctor and your health care team on insulin pump therapy as well as on the H TRONplus Insulin Pump Do not operate the H TRONplus Insulin Pump without knowing your personal settings The pump must be programmed with your personal settings prior to starting the therapy 6 H TRONplus Reference Manual 1 Warnings and precautions This section includes 1 1 Warnings 1 2 Precautions Caution R
92. section 3 2 2 remove both batteries Caution For preventing water from entering the pump case Change pump batteries only in a dry environment When changing a battery check that the black O ring is correctly in stalled and seated properly Do the following 1 gt Disconnect or remove the infusion set Remove both batteries Press S and hold for three seconds 2 gt Reinsert the battery in compartment 3 electronic Be sure that it is tight Tight means that the top of the battery is level with the pump case Do not over tighten 3 gt Press S and wait for the numbers to scroll from 0 to 9 If the pump alarms ERROR 02 silence the alarm ERROR 02 stays on the display Press S to clear the display Go to step 4 If the pump alarms ERROR 07 or ERROR 03 remove the battery go to step 5 4 gt Reinsert the battery in compartment 2 motor Be sure that it is tight Tight means that the top of the battery is level with the pump case Do not over tighten Set the clock and review the basal rates Change the pump to RUN If the pump alarms ERROR 07 remove both batteries and go to step 5 H TRONplus Reference Manual 67 5 gt Press S and hold for 3 seconds Insert a NEW battery in com partment 3 electronic Press S and wait for the numbers to scroll from 0 to 9 If the pump alarms ERROR 02 silence the alarm ERROR 02 stays on the display Press S to clear the display Go to step 6
93. should be filled accurately so that its actual volume matches the calculated reset volume for a half filled cartridge H TRONplus Reference Manual 81 10 ome This section includes 10 1 Repair and technical inspection 10 2 Maintenance and cleaning 10 2 1 System check 10 2 2 Insulin pump 10 2 3 Piston rod 10 2 4 Pump adapter 10 2 5 Cartridge and infusion set 10 3 Store the pump 10 4 Battery information 10 5 Your pump checklist 10 6 Package and return the pump Disetronic Medical Systems AG as manufacturer guarantees the functions of the H TRONplus Insulin Pump according to the specifications on condition that all the servicing of the H TRONplus is done by Disetronic or a Technical Service Center authorized by Disetronic The pump has no scheduled maintenance during the operating time Do not do any servicing or repair on the pump by yourself 10 1 Repair and technical inspection Return the pump to Disetronic in the following situations For any technical inspection In case of troubles such as an ERROR can not be cleared by follo wing the procedure described in section 7 After the first 24 months of use a pump must be returned for a technical inspection The pump alerts you when the time for the technical inspection nears which allows you to change to your back up insulin delivery device The pump alarms technical inspection ERROR 88 eight weeks before the inspection is due and then again at tw
94. sion site making sure that insulin is dripping from the needle and there is no air in the system Change pump to RUN If the pump alarms ERROR 04 go to step 4 4 gt Check to make sure that the infusion set is removed from the site Remove the cartridge from the pump with piston rod adapter and infusion set attached Prime If the pump does not alarm ERROR 04 go to step 5 If the pump alarms ERROR 04 change battery in compartment 2 motor and prime If the pump does not alarm ERROR 04 insert the cartridge with piston rod adapter and infusion set back into the pump Replace infusion set with a new one and prime Insert the infusion set into a newly prepared infusion site Put pump into RUN If the pump alarms ERROR 04 go to step 7 64 H TRONplus Reference Manual 5 gt Insert cartridge with piston rod adapter and infusion set re attached to the cartridge chamber of the pump Screw the adapter onto the cartridge chamber Remove infusion set from the adapter Prime If the pump does not alarm ERROR 04 attach a new infusion set and prime Insert a new infusion set into a newly prepared infusion site after ensuring that insulin drips from the needle and there is no air in the system Change the pump to RUN If the pump alarms ERROR 04 go to step 6 6 gt Remove cartridge with piston rod and replace with new car tridge and new piston rod if available Insert new cartridge with piston rod
95. slits display is free of cracks or incomplete characters the temporary basal rate changes are set or planned according to your health care team s recommendations the emergency kit or travel kit with supplies is available when needed the back up pump or alternate insulin delivery method is available when traveling the beeps are turned on or off as desired H TRONplus Reference Manual 87 10 6 Package and return the pump A pump may be returned to Disetronic Technical Service when approved Pack the pump so it can travel safely For example put the pump back in the original carrying case and put the case in a package that will not rip or tear It is best to send the pump by a carrier that tracks the shipment Some examples of tracked shipments are Federal Express 2 day economy UPS ground track registered mail express mail certified mail Remember to include a note with the return number provided by Disetronic a description of the reason for returning the pump your name and address your daytime phone the serial number of your pump If your pump is not covered under your homeowners insurance policy you may want to insure it with the shipper for its full value Your pump should be returned to Technical Service Disetronic Medical Systems Inc 5151 Program Avenue St Paul MN 55112 1014 USA Phone 1800 688 4578 88 H TRONplus Reference Manual 11e 11 1 Technical data
96. ss S until the cursor points to basal The display shows Pr U because the program is unlocked basal_ lt je yg E Pek 2 gt Within 12 seconds press h m and S at the same time until Pr L is displayed The basal rate program is now locked basal 42 4 14 5 g gt data ia After 12 seconds the pump returns to the default STOP display EIU To unlock the basal rates the pump must be in STOP If during programming no button is pressed for 12 seconds the pump returns to the default STOP display 1 gt Press S until the cursor points to basal The display shows Pr L because the program is locked basal 4 J Z u Pr ou 2 gt Within 12 seconds press h m and S at the same time until Pr U is displayed The basal rate program is now unlocked basal 4 J Z yg 5 g gt data SIOR After 12 seconds the pump returns to the default STOP display H TRONplus Reference Manual 57 PMB e Short explanation of the error code list ERROR CODES moves This section includes 01 Empty Cartridge 07 System Alarm shown on the back of the H TRONplus 7 1 Alarm ERROR 01 Empty Cartridge ti Lon Een tarer G o Teniel fa le Insulin Pump 7 2 Alarm ERROR 02 Low Motor Battery 2 Rite ree wth Eee 7 3 Alarm ERROR 03 Low Electronic Battery 3 06 Automatic Off Basal Rate 7 4 Alarm ERROR 04 Occlusion 5D DISETRONIC 1 800 688 4578 Always refer to the detail
97. sulin Check expiration date of insulin Do not store vial or filled cartridge where it could freeze or over heat Short acting insulin should appear clear upon inspection Change to new bottle of insulin Consider half filling cartridge H TRONplus Reference Manual 75 Troubleshooting high blood glucose hyperglycemia gt continued Pump Infusion set causes Suggested Action Large air bubbles in cartridge or tubing Disconnect and prime infusion set to remove air or replace cartridge and re prime Make sure all connections are secure Blood in tubing Empty or reused cartridge Change infusion set and site Replace cartridge Cartridges are for single use only Do not reuse Disconnected or dislodged infusion set Tug on connections to check security Check for wetness due to leaking insulin Check blood glucose level Leak in system Look and feel for wetness due to leaking insulin at all connections and on the skin Blockage in system Change infusion set site cartridge Check piston rod and change if necessary Incorrect clock setting The correct hourly basal rate may not be delivered if the time is incorrect Check the clock on regular basis and when replacing battery s Failure to complete prime Always prime until insulin drips from the end of the tubing and the tubing is free of air Pump in stop for extended period Consult health care team for allowab
98. sulin Pump beeps when a button is pressed when there is an alarm or when there is a warning The beep tones alert you to a change in the pump The beeps may be long HEEE or short Warning If you silence beeps check the display of the H TRONplus Insulin Pump regularly This is the only way you will be aware of any changes in the pump in a timely manner The following beeps can be silenced Warning beeps Confirmation beeps Beeps when buttons are pressed Alarms cannot be silenced To silence the beeps the pump must be in STOP If during programming no button is pressed for eight seconds the pump returns to the default STOP display 1 gt Press S until the cursor points to clock 2 gt Within eight seconds press h and m at the same time the pump will confirm this action by a short beep and hold for three seconds The beeps are silenced when the cursor points to data clock H TRONplus Reference Manual 55 To restore the beeps the pump must be in STOP 1 gt Press S until the cursor points to clock 2 gt Within eight seconds press h and m at the same time and hold for three seconds The beeps are restored when the cursor points to data and the pump beeps clock Note If both batteries are removed at the same time the beeps are automatically re stored when batteries are reinserted 6 4 Control the STOP Alarm status STOP Warning When the H TRONplus Insu
99. ten or remove the Hag sida Use the hole in the top to put the tool on your key chain wear it has to be replaced every year Always make sure that the cog wheel spins freely on the piston rod The nylon end cap should spin and Q Piston rod A The piston rod moves the plunger of the cartridge forward Due to vy Si Q the metal rod should be clean Cartridge The sterile packed cartridge set contains all items required to fill the cartridge with insulin The cartridge is a sterile product intended for single use only Sterility is guaranteed for unopened packaging up to the indicated expiration date Do not use if package is damaged Do not reuse single use materials Reuse of single use materials might lead to a malfunction of the pump and to the administration of an incorrect amount of insulin and or an infection H TRONplus Reference Manual 1 9 Pump Adapter The pump adapter makes a reliable connection between the pump _ cartridge and the infusion set At the same time it seals the cartridge ws OUD compartment with O rings Inspect the O rings before putting the pump adapter on the pump They should not show signs of wear The two small openings on the adapter allow air pressure to equalize The holes should not be plugged or the air pressure can not equalize The pump adapter has to be changed every 6 months Infusion set The infusion set connects the pump the cartridge and the body and is therefore a crucial pa
100. tool until the top of the battery is level with the pump case Over tightening may cause pump case damage Sun and UV radiation and heat l Caution Do not place the pump in direct sunlight Overheating of the insulin and the pump must be avoided Caution Temperatures over 122 F 50 C may damage the insulin Temperatures over 149 F 65 C may also damage the electronics of the pump Only use the H TRONplus within its temperature limits f Warning Always remove your H TRONplus before you enter a sauna hot tub or a Jacuzzi Do not use the pump in water Cold Caution Use of your pump at temperatures under 41 F 5 C may cause a I malfunction of the batteries Wear your pump under your clothes or directly on your body in cold weather H TRONplus Reference Manual 1 1 Variation of the air pressure Caution The pump adapter has two holes to allow the variation in air pressure within the cartridge compartment Never plug the two holes In this way a variation of the air pressure for example in an airplane or when climbing on a mountain does not affect the pump or the dosage of the insulin Control the beeps special function Caution The H TRONplus allows users to silence warning beeps confirma tion beeps and beeps when buttons are pressed The beeps caused by an alarm ERROR message can not be silenced when the pump is in RUN Check the display of the H TRONplus Insulin Pump regularly especially if for any reason you mi
101. tteries Reinsert the batteries by following the procedure des cribed above Energy Saver Note The display goes blank after 30 seconds if no buttons are pressed It remains blank until buttons are pressed To view the display again press h and m at the same time for one second 24 H TRONplus Reference Manual 3 1 2 Change the batteries status STOP Caution Change the battery only in a dry environment and do not remove both batteries simultaneously Check that the black O ring is correctly installed and seated properly See section 3 1 insert and change batteries for further precautions It is usually not necessary to change both batteries at the same time When the pump alarms ERROR 02 change the battery in compartment 2 motor When the pump alarms ERROR 03 change the battery in compartment 3 electronic To change a battery 1 gt Press S and hold for three seconds to silence the ERROR alarm if present 2 gt Press h and m and hold for a least three seconds to change to STOP unless the pump is already in STOP 3 gt Remove the battery from the pump using the battery mr tool and replace it with a new battery h 4 Be sure the battery is tight Tight means the top of the i gt battery is level with the pump case DO NOT OVER TIGHTEN Over tightening may cause pump case damage 5 gt Check the clock and review basal rate programming See section 3 5 6 gt Change to RUN 3 2 Insert remo
102. ve both batteries 3 2 1 Insert both batteries Inserting the batteries will power the pump and start the time to technical inspection counter This counter is set for 24 months Please refer to the section 10 1 repair and technical inspection in this reference manual for further information Once the pump is powered you need to program the pump to your individual needs H TRONplus Reference Manual 25 3 2 2 Remove both batteries status STOP or RUN Caution Only remove both batteries if required to clear some pump alarms or if you are stopping use of the pump for a longer time period e g when changing to a replacement pump troubleshooting some pump alarms or when returning the pump for technical inspection Insulin delivery as well as the time to technical inspection counter will be interrupted if both batteries are removed 1 gt Change the operating status to STOP if the pump is still in RUN 2 gt Remove both batteries using the battery tool and cover the openings of the compartments with the battery compartment pro tective covers If both batteries are removed three events occur when the batteries are reinserted Data Memory is cleared including current settings such as temp orary basal rate changes or programmed bolus and the history of bolus and ERRORS Only the basal rate programming is not lost Note that if only one battery is removed and reinserted or replaced data memory is not reset The pu
103. wear the pump e g during a vacation at the beach to avoid getting sand into the pump or when outside in very hot and sunny climate to avoid overheating the insulin when the pump needs maintenance or repair Change the pump to STOP Remove the cartridge and the infusion set Remove both batteries and insert the battery compartment covers Connect the adapter to the pump and store the pump according to the right temperature conditions see section 11 technical data or if necessary send the pump to Disetronic Pr al 80 H TRONplus Reference Manual 9 3 Use of a partially filled cartridge plastic cartridges only Warning If the actual amount of insulin in the cartridge does not match the calculated amount of insulin you may or may not get a cartridge low warning ERROR 10 and or empty cartridge ERROR 01 If neither ERROR 10 nor ERROR 01 alerts you about the necessity of a cartridge change then ERROR 04 occlusion will alarm to indicate the cartridge is empty Proceed as indicated for ERROR 04 see chapter 7 4 Alarm ERROR 04 occlusion A half filled plastic cartridge may be used in the pump To accurately half fill a cartrid ge with 150 units the top of the plunger must be positioned between the 140 and 160 marker lines Once the cartridge is half filled the pump must be reset for a new half filled cartridge see section 4 4 2 reset new half full plastic cartridge Any partially filled cartridge
104. x only The device is restricted to sale by or on the order of a g licensed health care practitioner Prior to starting the pump be aware of the following warnings and precautions 1 1 Warnings Warning Avoid any contact of the pump with water Water entering the pump may result in a malfunction which could cause severe hypoglycemia low blood glucose value or complete pump shut down Should your pump come into contact with water check whether Water has gotten inside the pump case or whether water is visible in the display area The cartridge contents expected agree with the insulin remaining counter on the display If you detect water in the pump casing or think the cartridge contents are inconsistent with what you expect then put the pump in STOP immediately and take the following steps Remove the infusion set from your body Measure your blood glucose value and correct it if necessary per your doctor s orders Ifyou are unable to correct your blood glucose value contact your health care provider immediately or get transportation to the nearest emergency room If you are able to correct your blood glucose value inspect the system i e the pump the adapter and the infusion set H TRONplus Reference Manual 7 If you detect a problem follow the instructions for returning your pump and continue therapy with your back up insulin delivery device Call the toll free number on the back of y
105. y check your blood glucose level because delivery of insulin may have been interrupted If blood glucose is high treat according to your health care team s instruct ions An ERROR 04 may be caused by an empty cartridge a reused cartridge a blocked infu sion set a dirty or damaged piston rod or a low battery in compartment 2 motor A Warning A leakage in the system is not detectable by the insulin pump Therefore check the cartridge the infusion set and its connections regularly Should you detect any loss of insulin replace the leaking component i Warning Air bubbles in the cartridge and in the infusion set cause the infusion of air instead of insulin Your body will not receive the required amount of insulin An occlusion ERROR 04 may be delayed Remove these bubbles while filling the cartridge and priming the infusion set Cold insulin may release dissolved air when warmed Use only insulin at room or pre ferably body temperature when filling the cartridge and priming the infusion set Check the system for air bubbles regularly and if necessary change system components according to the procedure described in the reference manual in section 4 prepare the cartridge and attach the infusion set or in section 5 4 change a cartridge and an infusion set Warning Never carry out the functions program the basal rate change the cartridge and prime the infusion set with an infusion set inserted into

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