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Warnings and precautions

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Accu-Chek D-TRONplus insulin pump Reference Manual

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Accu-Chek D-TRONplus insulin pump Reference Manual

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This section includes:

1.1 Warnings
1.2 Precautions

Caution: Rx only.

This device is restricted to sale by or on the order of a

physician.

Prior to starting your Accu-Chek D-TRONplus insulin pump, it is important that you
are aware of the following general warnings and precautions.
Specific warnings and cautions please refer to the concerning chapters.

1.1 Warnings

Warning: Incorrect programming of your insulin pump

may

cause inappropriate insulin delivery. Your insulin pump must be pro-
grammed with your personal settings prior to starting insulin pump ther-
apy. Do not operate your insulin pump without knowing your personal
settings. If you are not sure about your personal settings or you are less
experienced, have your doctor and/or your health care team check your
personal settings. Work with your doctor and/or your health care team to
determine the timing, amount and type of bolus you need to deliver. Make
sure you know your personal insulin/carbohydrate ratio and your correc-
tion bolus ratio.

Warning:

Do not use your Accu-Chek D-TRONplus insulin pump if you

are not able to read the display, hear the beeps or you are not able to feel
the vibrations. The display, beeps and vibrations indicate critical alert
information and must be addressed immediately by the insulin pump user.
Failure to see, hear or feel the alerts from the insulin pump could result in
serious harm or death of the user.

Continuous Subcutaneous Insulin Therapy (CSII) using
your insulin pump

You must be trained by your doctor and/or your health care team on pump
therapy as well as on your insulin pump.
Refer to section 1.2 “Precautions” regarding the contraindications for the
use of a Accu-Chek D-TRONplus insulin pump.
Do not operate your insulin pump without knowing your personal settings.

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Содержание D-TRONplus

Страница 1: ...INSULIN PUMP Reference Manual ...

Страница 2: ...Front Back Display Cartridge compartment Adapter Control keys PowerPack compartment Year of manufacture Errors and Alerts Serial number Infrared interface ...

Страница 3: ...our insulin pump are unique Therefore it is important that you or your health care team fill in the following information Accu Chek D TRONplus Insulin Pump Serial number Insulin name type U100 Training Place Date s Trainer Useful Your contact for medical emergencies and or information addresses about pump therapy doctor health care team Telephone ...

Страница 4: ...0529 Federal law USA restricts this device to sale by or on order of a physician Electronic device of type BF according to the standard IEC 60601 1 Protection against electric shock Warning Disregarding this warning may seriously harm your health or could result in death Caution Disregarding this safety instruction may harm your health or cause a malfunction of your insulin pump and or its accesso...

Страница 5: ... pump 47 3 1 Insert and change the PowerPack 48 3 1 1 Insert the PowerPack 49 3 1 2 Change the PowerPack 51 3 2 Review or set time and date 55 3 3 Program the basal rate profiles 59 3 3 1 Program all hourly basal rates 60 3 3 2 Copy an hourly basal rate 63 3 3 3 Change selected hourly basal rates 64 3 4 Review basal rate programming 65 4 Prepare the cartridge and attach the adapter and infusion se...

Страница 6: ...and water 162 9 4 Electromagnetic fields and hazardous areas 163 9 5 Sports 169 9 6 Travelling 169 Accu Chek D TRONplus insulin pump Reference Manual 6 4 2 Return the piston rod 75 4 3 Insert the cartridge 77 4 4 Connect the adapter and infusion set 78 4 5 Prime the infusion set 80 4 6 Select and prepare an infusion site 84 5 Operate your Accu Chek D TRONplus insulin pump 87 5 1 Start and stop ins...

Страница 7: ...out operating and troubleshooting your insulin pump If you have further questions please contact your Accu Chek customer service center for insulin pumps or your doctor and or your health care team Reference manual This reference manual is written for you as well as health care professio nals It is designed to provide you with the necessary information for safe and efficient use of your insulin pu...

Страница 8: ...e your doctor and or your health care team check your personal settings Work with your doctor and or your health care team to determine the timing amount and type of bolus you need to deliver Make sure you know your personal insulin carbohydrate ratio and your correc tion bolus ratio Warning Do not use your Accu Chek D TRONplus insulin pump if you are not able to read the display hear the beeps or...

Страница 9: ...y Sterility is guaranteed for unopened packaging up to the indicated expiration date Do not use if package is damaged Accu Chek D TRONplus insulin pump Reference Manual 13 Accu Chek D TRONplus insulin pump Reference Manual 12 Do not reuse single use materials Reuse of single use materials might lead to a malfunction of your insulin pump and to incorrect insulin delivery and or an infection Always ...

Страница 10: ...ount of insulin An Error E4 Occlusion may be delayed Remove these bubbles while filling the cartridge and or priming the infu sion set Make sure the infusion set is not connected to your body Cold in sulin may release air when warmed Use only insulin at room temperature when filling the cartridge and priming the infusion set Warning Any changes or modification to the devices not expressly ap prove...

Страница 11: ... regularly that the time and date on your insulin pump your blood glucose measurement system PC and other used devices are identical Inspect the cartridge adapter and the infusion set for air bubbles at least every three hours during the day and before you go to sleep Remove any air bubbles and if necessary change system components Please refer to sections 4 Prepare the cartridge and attach the ad...

Страница 12: ...indications for insulin pump therapy are Patients with a history of obvious psychic or intellectual disturbances Patients with insufficient general mental and physical abilities Patients with a limited ability to see a defective hearing or a limited ability to feel vibrations Unreliable patients Patients that are not motivated to adopt pump therapy Patients who are not willing or do not have the p...

Страница 13: ... 11 Technical data In cold weather wear your insulin pump under your clothes or directly on your body Only use your insulin pump within its operating tem perature range Avoid a rapid major increase of temperature because this may lead to malfunction Accu Chek D TRONplus insulin pump Reference Manual 21 Accu Chek D TRONplus insulin pump Reference Manual 20 Cold Caution Use of your insulin pump at t...

Страница 14: ...the only way you will be aware of any changes in your insulin pump in a timely manner of your Accu Chek D TRONplus insulin pump Accu Chek D TRONplus insulin pump Reference Manual 22 Cleaning Caution Do not use solvents strong detergents acidic or alkaline based substances bleaching agents scouring pads or sharp instruments for cleaning as they may damage your insulin pump Only use a soft dry cloth...

Страница 15: ...only if they have not been turned off Beeps occur only if they have not been turned off Beeps occur only if they have not been turned off Beep Short beep of high tone pitch confirms each a key press Short beep of low tone pitch confirms each s key press Short beep of medium tone pitch confirms each d key press A sequence of four beeps in rising tone pitches melody occurs to confirm each f key pres...

Страница 16: ...lay to make sure that you have programmed the desired values Scrolling function In order to enter larger values a key must normally be pressed several times How ever in certain situations you can hold the key pressed scroll until the desired value appears on the display The value can be corrected by single key press if needed Volume Caution The beep volume can be adjusted to different levels in th...

Страница 17: ...l single beep while scrolling The word scroll is used in the instructions when the scrolling function is available Display The display of your insulin pump shows you all its functions and presents important information This section describes how the display works and the symbols and num bers it uses Caution If you discover incomplete characters or numbers in the display perform a system check of y...

Страница 18: ...n pump beeps a short beep You can il luminate the display in RUN or STOP even when an alert or error message appears or when the KeyLock is activated The backlight helps you operate your insulin pump or read the information in poorly lit conditions e g in bed at the cinema etc The backlight turns off automatically after 30 seconds if no further keys are pressed Remaining cartridge content Cartridg...

Страница 19: ...made are not saved This parameter may vary based on the standard configuration of your insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool 2 3 Operating status STOP RUN The operating status of your Accu Chek D TRONplus insulin pump may be either STOP or RUN RUN During normal use your insulin pump is in RUN and insulin is continuously delivered basal rate A bolus can be p...

Страница 20: ...changes you just made are not saved Remaining cartridge content Your insulin pump allows you to easily check the remaining cartridge content insulin remaining in the cartridge in units while in STOP or RUN To check the remaining cartridge content 1 Make sure that the PowerPack is inserted the function prime the infusion set has been programmed and the KeyLock is deactivated or the keys are unlocke...

Страница 21: ...or and or your health care team to check your personal settings Your insulin pump is provided with standard configuration factory settings You may need to adapt these parameters to meet your individual needs Always consult your doctor or health care team before adapting parameters All changes which can be made on your insulin pump can also be made on a personal computer PC using Accu Chek DiaLog P...

Страница 22: ...tion of your insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool Parameter Active basal rate profile Select basal rate profile Basal rate profile programming Program basal rate profile A Program basal rate profile B Maximum basal rate Alert at end of temporary basal rate Bolus increment per key press standard bolus Adjust the bolus increment Maximum bolus amount per deli...

Страница 23: ...s other than those supplied or recommended may significantly reduce the service life of the PowerPack and may lead to leakage and corrosion of the PowerPack contacts within your insulin pump The use of PowerPacks not supplied or recommended may void the warranty 2 6 Accessories and disposables Caution Only use accessories and disposables that are designed for use with your Accu Chek D TRONplus ins...

Страница 24: ... compartment of your insulin pump The built in valve prevents the uncontrolled seepage of the insulin cartridge in case of pressure and level differences between your insulin pump and the infusion site siphoning effect Pre filled 3 0 ml Humalog pen cartridges are manufactured by Eli Lilly The service life of the PowerPack is affected by usage of your insulin pump delivery rates temperature and oth...

Страница 25: ...loped for use with Accu Chek infusion sets Other infusion sets may not have been tested for compati bility with your Accu Chek D TRONplus insulin pump and may endanger your health if used 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 damaged Caution The adapter should only ...

Страница 26: ...h as cartridges and infusion sets should not be reused due to the in creased risk of infections malfunctions and or incorrect insulin delivery Caution Always pay attention to the operating status of your in sulin pump STOP or RUN The functions of your insulin pump can only be performed if your insulin pump is in the correct operating status Always make sure that you are in the correct operating st...

Страница 27: ...from entering the pump casing change the PowerPack only in a dry and clean environment and make sure that the seal ring is not worn out or missing and that the PowerPack is properly inserted Tighten or loosen the PowerPack cover with the battery tool supplied with your Accu Chek D TRONplus insulin pump use of coins knives screwdrivers or other sharp objects may harm your insulin pump Do not over t...

Страница 28: ...totals history of alerts and errors remain irrespective of the PowerPack voltage and the time your insulin pump has been without a PowerPack 3 1 2 Change the PowerPack 1 Make sure your Accu Chek D TRONplus insulin pump is in STOP 2 Remove or disconnect your infusion set from the site After inserting the PowerPack your insulin pump performs the following start up pro cedure The display indicates th...

Страница 29: ...st your in sulin pump does not beep a sequence of three and two short beeps and or does not vibrate once please contact your Accu Chek customer service center for insulin pumps The numbers in the three number groups go from 0000 to 9999 Check if the numbers appear completely Your insulin pump beeps a melody to inform you that the start up procedure has ended Your insulin pump returns to STOP If yo...

Страница 30: ...ou may not be notified of any changes of your insulin pump in a timely manner Please contact your Accu Chek customer service center for insulin pumps Caution Do not interrupt the start up procedure by pressing keys or in serting a cartridge or adapter Interruption of the start up procedure may lead to malfunctions of your insulin pump Caution If your insulin pump does not beep and vibrate as descr...

Страница 31: ...he hour This parameter may vary based on the standard configuration of your insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool Time and Date The time and date can be set in the following formats American 12 hour clock AM PM mm dd yyyy US e g 04 26 2004 or European 24 hour clock 00 00 23 59 dd mm yyyy EU e g 26 04 2004 12 hour clock 24 hour clock 12 00 AM 00 00 1 00 AM 0...

Страница 32: ...Your insulin pump offers the option of administering two different basal rate profiles A and B Always consult your doctor or health care team before changing basal rate profiles Discuss programming a second basal rate profile with your doctor or health care team If you and your doctor decide that a second basal rate profile is not necessary you should program basal rate profiles A and B with the s...

Страница 33: ...onfirm your changes with f The changes you just made are marked to save but not saved yet The new daily basal rate total is displayed In this example the new daily basal rate total is 20 0 units 9 Check the new daily basal rate total and confirm it within 20 seconds with f The changes you just made are saved After a short pause the programmed changes are saved and your insulin pump returns to RUN ...

Страница 34: ...ith f The changes you just made are marked to save but not saved yet The new daily basal rate total is displayed In this example the new daily basal rate total is 20 0 units Info If f is not pressed within 20 seconds your insulin pump automa tically returns to RUN timeout The changes you just made are not saved If you do not want to go through all the steps of the basal rate programming you may ex...

Страница 35: ...locked This parameter may vary based on the standard configuration of your insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool 7 Check the new daily basal rate total and confirm it within 20 seconds with f The changes you just made are saved After a short pause the programmed changes are saved and your insulin pump returns to RUN The current basal rate is displayed Info ...

Страница 36: ...ty is guar anteed 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 your insulin pump and to incorrect insulin delivery and or an infection Always handle the items with clean hands Caution Use specified cartridges only The use of other cartridges can lead to malf...

Страница 37: ...illing aid can be used to help you to fill an empty 3 0 ml glass cartridge from your vial of insulin Please refer to section 4 1 Fill the cartridge for further information 4 1 Fill the cartridge Caution Air bubbles in the cartridge adapter and in the infusion set cause the infusion of air instead of insulin Your body does not receive the required amount of insulin An Error E4 Occlusion may be dela...

Страница 38: ...the following materials ready New 3 15 ml plastic cartridge with protective cap and plunger rod New filling needle with protective cap New 3 0 ml glass cartridge CombiFill base and extension Insulin at room temperature to minimize formation of air bubbles 2 Wash your hands 3 Remove the plastic cartridge plunger rod protective cap and filling needle from the blister pack Caution Be careful not to t...

Страница 39: ...t the filling needle has pierced the rubber membrane of the glass cartridge 22 Push the plunger rod down slowly and briefly then release it and allow it to slide back This gentle pumping action allows you to inject the insulin from the plastic cartridge into the glass cartridge 17 17 19 22 24 11 Push the plunger rod down so that all air from the plastic cartridge enters the insulin vial 12 While h...

Страница 40: ... Accu Chek DiaLog Pump Programming tool 23 Slowly repeat the pumping process until the glass cartridge is filled with insulin and free of air bubbles 24 Allow the plunger rod of the plastic cartridge to slide back to the mechanical stop of the CombiFill base By doing so pressure is equalized and an uncontrolled lea kage of insulin from the glass cartridge is avoided 4 1 4 Remove the cartridges fro...

Страница 41: ...rtridge into the cartridge compartment Make sure that the rubber membrane points upwards 5 Press f for 3 seconds until your insulin pump beeps a melody and the piston rod starts to return Caution Should the piston rod not return all the way please contact your Accu Chek customer service center for insulin pumps After the piston rod has returned completely your insulin pump performs a self test All...

Страница 42: ... of the adapter and the infusion set 4 Twist the infusion set by hand clockwise into the adapter Caution Properly tighten the infusion set to the adapter to avoid leakage Turn the infusion set luer lock connector only as far as the stop Do not turn it any further and do not use any auxiliary tools as this may crack the infusion set luer lock connector and result in leakage Your insulin pump cannot...

Страница 43: ...ulin used for the prime function is not added to the history of daily totals Please read the following instructions in order to minimize air bubbles in your system This parameter may vary based on the standard configuration of your insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool 6 Slowly rotate the adapter clockwise into the lock position 4 5 Prime the infusion set W...

Страница 44: ...air bubbles inside the car tridge will move to the top Wait until the insulin flows from the adapter into the luer of the infusion set This parameter may vary based on the standard configuration of your insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool 6 First tap your insulin pump against your palm while holding it upright Then tap your insulin pump against your palm ...

Страница 45: ...the first time in the presence of your doctor and or your health care team Regular medical examinations are required Always follow the instructions given by your doctor and or your health care team and the in structions for use of the sterile products and accessories you are using Caution If you detect blood in your infusion set you have most likely nicked a blood vessel causing the risk of an occ...

Страница 46: ...D TRONplus insulin pump operations can only be performed if the insulin pump is in the correct operating status Caution In order to begin insulin delivery there must be a cartridge in your insulin pump the adapter with connected infusion set must be in serted and the infusion set must be primed If your insulin pump is in RUN when the cartridge compartment is empty or if the piston rod is not advan...

Страница 47: ... information This parameter may vary based on the standard configuration of your insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool 5 1 Start and stop insulin delivery When yourAccu Chek D TRONplus insulin pump is in STOP it does not deliver insulin When your insulin pump is in RUN it delivers insulin every 3 minutes following the programmed basal rate Boluses may be pr...

Страница 48: ... ratio and your correction bolus ratio Your insulin pump allows for the delivery of three types of bolus standard bolus fast delivery scroll bolus scrolling fast entry and delivery extended bolus delivery over a programmed period of time Review bolus history The time date and amount of the last 10 boluses can be reviewed in the bolus history Please refer to section 6 1 1 Review the bolus history f...

Страница 49: ... insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool If the beeps have been turned off your insulin pump only vibrates for confirmation 5 2 1 Standard bolus The standard bolus function involves the a and s keys only To program a standard bolus To start with the s key 1 Make sure your insulin pump is in RUN and the KeyLock is deactivated or the keys are unlocked 2 Press s...

Страница 50: ...ns when using the scroll bolus Bolus delivery starts immediately after confirmation of the programmed amount To program a scroll bolus 1 Make sure your insulin pump is in RUN and the KeyLock is deactivated or the keys are unlocked Beeps occur only if they have not been turned off 5 5 seconds after the confirmation your insulin pump beeps three times and starts to deliver the total bolus amount pro...

Страница 51: ...e digested slowly e g pizza The use of the extended bolus can also be ap propriate with people who have gastroparesis delayed digestion Beeps occur only if they have not been turned off 2 Press d once to select the bolus menu The last bolus from the bolus history is displayed Please refer to section 6 1 1 Review the bolus history for further information 3 Confirm with f 4 Press scroll a to increas...

Страница 52: ...ssed within 20 seconds your insulin pump automa tically returns to RUN timeout and no bolus is delivered These parameters may vary based on the standard configuration of your insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool Beeps occur only if they have not been turned off Info Discuss the use of an extended bolus with your doctor or health care team Info The bolus am...

Страница 53: ...ean environment and check always that the cartridge compartment is free of any dirty particles Avoid your insulin pump the infusion set and es pecially the connecting parts of your insulin pump coming into contact with health and beauty items e g antiseptics antibiotic creams soaps perfumes deodorants body lotions or any other cosmetics They may cause damage to these parts To cancel an extended bo...

Страница 54: ...day and before you go to sleep Remove any air bubbles and if necessary change system components Caution Always handle the items with clean hands Avoid your insulin pump the infusion set and especially the connecting parts of your insulin pump coming into contact with health and beauty items e g antiseptics antibiotic creams soaps perfumes deodorants body lotions or any other cosmetics They may cau...

Страница 55: ...during the day and before you go to sleep Remove any air bubbles and if necessary change system components Caution Always work with clean hands Avoid your insulin pump the in fusion set and especially the connecting parts of your insulin pump com ing into contact with health and beauty items e g antiseptics antibiotic creams soaps perfumes deodorants body lotions or any other cosmetics They may ca...

Страница 56: ...use of single use materials might lead to a malfunction of your insulin pump and to incorrect insulin de livery and or an infection Always handle the items with clean hands 6 Set up your insulin pump with the new infusion set Please refer to section 4 Prepare the cartridge and attach the adapter and infusion set for further information Caution If the luer connection between the infusion set and ad...

Страница 57: ...k 6 8 1 Activate or deactivate the KeyLock 6 8 2 Unlock the keys 6 9 Review the time remaining 6 10 Data Transfer Warning Incorrect programming of your insulin pump may cause inappropriate insulin delivery Your insulin pump must be programmed with your personal settings prior to starting insulin pump therapy Do not operate your insulin pump without knowing your personal settings If you are not sur...

Страница 58: ...eview specific events such as 1 Bolus history last 10 boluses 2 History of daily totals last 7 daily totals 3 History of alerts and errors last 10 alerts and errors 4 Event history last 1400 events The last 1400 events representing about 90 days of continuous normal use are stored in the memory of your insulin pump The data memory can be transferred to a PC using Accu Chek DiaLog or other software...

Страница 59: ...tandard configuration of your insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool 6 1 2 Review the history of daily totals The history of daily totals enables you to review the last 7 daily totals from midnight to midnight of insulin delivered basal rate and boluses starting with the newest entry in chronological order To review the history of daily totals 1 Make sure yo...

Страница 60: ...Select your basal rate profile Your Accu Chek D TRONplus insulin pump offers two different basal rate profiles A and B Discuss programming a second basal rate profile with your doctor or health care team If you and your doctor decide that a second basal rate profile is not necessary you should program basal rate profile A and B with the same hourly basal rates Please refer to section 3 3 Program t...

Страница 61: ...ed or decreased in 10 increments 0 200 as needed 5 Press d to move to the duration The duration of the last increase or decrease flashes 6 Press scroll a to lengthen or s to shorten the duration The duration can be programmed between 1 and 24 hours in hourly intervals In this example a temporary decrease of 10 for 3 hours is programmed You can move back and forth between programming the tem porary...

Страница 62: ...firms the cancellation and an Alert A6 Temporary Basal Rate Cancelled occurs Silence and confirm the alert by pressing f twice Please refer to section 7 1 6 AlertA6 Temporary Basal Rate Cancelled for further information Option B 1 Put your insulin pump into STOP by pressing d twice and f once Caution Your insulin pump confirms the cancellation and an Alert A6 Temporary Basal Rate Cancelled occurs ...

Страница 63: ...he automatic off in 1 hour intervals 7 If you would like to set the automatic off function to OFF press scroll s until OFF appears in the display 8 Confirm with f Your Accu Chek D TRONplus insulin pump returns to RUN Info If f is not pressed within 20 seconds your insulin pump automa tically returns to RUN timeout The changes you just made are not saved 6 5 Adjust the beep volume Your insulin pump...

Страница 64: ...k is deactivated or the keys are unlocked This parameter may vary based on the standard configuration of your insulin pump and changes made using the Accu Chek DiaLog Pump Programming tool Info The volume of the STOP Warning is independent of the pro grammed beep volume It always occurs at the maximum level 6 6 Adjust the bolus increment The bolus increment for the standard bolus function is set t...

Страница 65: ...cked before the KeyLock can be deactivated or any other programming of your insulin pump can be performed The KeyLock is deactivated in the standard configuration It can be changed in the SETUP menu only 6 8 1 Activate or deactivate the KeyLock To activate or deactivate the KeyLock 1 Make sure your insulin pump is in RUN and the KeyLock is deactivated or the keys are unlocked 2 Press d 9 times to ...

Страница 66: ... the KeyLock is activated and the keys are locked 2 Press and hold d and s simultaneously for 3 seconds Your insulin pump beeps once when the simultaneous key press is accepted and beeps a melody to confirm that the keys have been unlocked Beeps occur only if they are not been turned off 3 Confirm with f 4 Press d 5 times to move to the KeyLock function 5 Confirm with f The KeyLock symbol flashes ...

Страница 67: ...us insulin pump is equipped with two timers The first timer t1 is activated within the standard configuration of your insulin pump It counts the days which remain until the End of Use Time If 56 days remain before the End of Use Time your insulin pump indicates this with an Alert A5 End of UseTimeAlert The t1 symbol remains on the display as a reminder This ensures that you have enough time to pla...

Страница 68: ... feature To activate the data transfer from your insulin pump 1 Make sure your insulin pump is in STOP and the KeyLock is deactivated or the keys are unlocked 2 Press d 4 times to select the data transfer function 3 Confirm with f The built in infrared interface is active and your insulin pump is ready for the data transfer Your insulin pump automatically returns to STOP approximately 15 minutes a...

Страница 69: ... Alert A4 Cartridge Adapter Alert 7 1 5 Alert A5 End of Use Time Alert 7 1 6 Alert A6 Temporary Basal Rate Cancelled 7 1 7 Alert A7 Temporary Basal Rate Over 7 1 8 Alert A8 Bolus Cancelled 7 2 Overview of the errors 7 2 1 Error E1 Empty Cartridge 7 2 2 Error E2 PowerPack Depleted 7 2 3 Error E3 Automatic Off 7 2 4 Error E4 Occlusion 7 2 5 Error E5 End of Use Time 7 2 6 Error E6 Mechanical Error 7 ...

Страница 70: ...sure that the cancellation was intended and program a new bolus if necessary 7 1 Overview of the alerts Alerts and errors Alerts warning instructions and errors error messages are shown on the display and are signalled first by vibrations followed by a combination of vibrations and a sequence of three then two short beeps Vibration etc Beep etc Info For your safety your insulin pump always beeps a...

Страница 71: ...rt code remains displayed Confirm that you have seen and understood the alert and clear the alert information from the display by pressing f again Your insulin pump returns to RUN or STOP Because an alert is not critical no immediate further steps must be taken However with an Alert A4 Cartridge Adapter Alert we recommend that you check your blood glucose level immediately and take the appropriate...

Страница 72: ...and infusion set for further information When finished reconnect the infusion set tubing and put your insulin pump into RUN press d and f 7 1 4 Alert A4 Cartridge Adapter Alert The unique force sensor of your Accu Chek D TRONplus insulin pump continuously measures the pressure on the cartridge plunger This feature determines whether a cartridge is present in the cartridge compartment and whether t...

Страница 73: ...r tridge compartment of your insulin pump Please refer to section 10 2 2 Your insulin pump for further information Set up your insulin pump with a new cartridge adapter and infusion set and prime Caution Broken cartridges can cause injury glass splinters Info Insulin is recognizable by its unique smell due to its preservatives therefore a defective car tridge may be recognized by smelling for leak...

Страница 74: ... intended and program a new temporary basal rate if necessary Please refer to section 4 Prepare the cartridge and attach the adapter and infusion set for further information When finished put your insulin pump into RUN press d and f Caution Broken cartridges can cause injury glass splinters Info Insulin is recognizable by its unique smell due to its preservatives therefore a defective car tridge m...

Страница 75: ...ror 7 2 Overview of the errors 7 1 7 Alert A7 Temporary Basal Rate Over An Alert A7 Temporary Basal Rate Over occurs when a temporary basal rate has ended Once the alert has occured the original basal rate 100 resumes automa tically Do the following 1 Silence and confirm the alert by pressing f twice 2 Decide whether a further temporary basal rate change is appropriate and program one if necessary...

Страница 76: ...Caution If necessary discuss the duration of the automatic off function with your doctor or health care team Confirmation of an error Caution Silence an error by pressing f This silences the beeps and vibra tions The error code remains displayed Confirm that you have seen and understood the error and clear the error information from the display by pressing f again Your insulin pump is in STOP Caut...

Страница 77: ... and Error E4 Occlusion continues to occur contact your doctor or health care team for an alternate therapy plan Contact your Accu Chek customer service center for insulin pumps for further assistance 7 2 4 Error E4 Occlusion The unique force sensor of your insulin pump continuously measures the pressure ratios in the system and triggers an Error E4 Occlusion if a defined value is ex ceeded The in...

Страница 78: ...n pump If an error is discovered the insulin delivery is stopped and an Error E7 Electronic Error occurs If the display is damaged it may not show the error code however your insulin pump beeps and vibrates 7 2 5 Error E5 End of Use Time An Alert A5 End of Use Time Alert occurs 56 days before the End of Use Time When the remaining time of use has reached zero an Error E5 End of Use Time occurs and...

Страница 79: ...nsert the PowerPack for further information 3 Reconnect your infusion set or connect a new one Please refer to section 5 5 Change the infusion set only for further information 4 When finished put your insulin pump into RUN press d and f Caution The piston rod may return after the insertion of the PowerPack If this occurs and you are using a disconnectable infusion set disconnect your infusion set ...

Страница 80: ...ime your infusion set to remove air or replace the cartridge and prime again Make sure all connections are secure Look and feel for wetness due to leaking insulin at all connections and on the skin Change your infusion set site cartridge and adapter Choose infusion sites without scar tissue bruises or tissue build up Do not use an infusion set or infusion site longer than recommended Insulin cause...

Страница 81: ...f your insulin carbohydrate ratio if necessary Re evaluate the percentage of basal adjustment for the level of activity Consult your health care team Other causes Decreased activity illness or stress Insulin pump in STOP for extended period Medication other than insulin Rebound from low blood glucose levels or dawn phenomenon rise in glucose levels in early morning hours Suggested actions Check wi...

Страница 82: ...atched with needs Incorrect time setting Priming the infusion set while it is inserted in the body Suggested actions When changing the cartridge adapter or infusion set disconnect at the site Disconnecting at the luer adapter end may cause unintended insulin delivery Always review any changes made in basal rate programming Check with your health care team about possible rate adjustment The correct...

Страница 83: ... your insulin pump to your Accu Chek customer service center for insulin pumps Please refer to sections 10 1 Repair and 10 6 Package and return your insulin pump for further information 9 2 Interruption of insulin pump therapy Consult your health care team about when and for how long pump therapy can be interrupted Short interruption 1 Put your Accu Chek D TRONplus insulin pump into STOP 2 Remove ...

Страница 84: ...pump upside down to let the water run out and let it dry Do not use warm air e g a hair dryer to dry This could damage the internal electronic components of your insulin pump Do not insert the PowerPack or the cartridge before the compartments are completely dry If you have any questions regarding these issues do not hesitate to contact your Accu Chek customer service center for insulin pumps Ples...

Страница 85: ...etic field IEC 61000 4 8 IEC 60601 test level 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV differential mode 2 kV common mode 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 3 A m Compliance level 8 kV contact 15 kV air IEC 60601 2 24 Not applicable Not applicable Not applicable 400 A...

Страница 86: ...lectromagnetic site surveya should be less than the compliance level in each frequency rangeb Interface may occur in the vicinity of equip ment marked with the following symbol Guidance and manufacturer s declaration electromagnetic immunity Note 1 At 80MHz and 800MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected ...

Страница 87: ...cy of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80MHz and 800MHz the separation distance for the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Recommended s...

Страница 88: ...osal Disetronic Medical Systems AG as the manufacturer guarantees the functions of your insulin pump according to the specifications on the condition that all servicing of your insulin pump is carried out by a Service Center which is authorized by Disetronic Medical Systems AG Your insulin pump has no scheduled maintenance during the use time Do not perform any servicing or repair on your insulin ...

Страница 89: ...aning Caution Do not use solvents strong detergents acidic or alkaline based substances bleaching agents scouring pads or sharp instruments for cleaning as they may damage your insulin pump Caution Always remove the cartridge and adapter and put your insulin pump into STOP while cleaning Avoid pressing the keys of your insulin pump during cleaning as this may accidentally change your pump settings...

Страница 90: ...iately Warning Any changes or modification to the devices not expressly ap proved by Disetronic Medical Systems AG could void your ability to ope rate the Accu Chek D TRONplus insulin pump and date are set correctly If you are not sure about your personal settings or you are less experienced contact your doctor and or your health care team to check your personal settings 10 2 3 If your insulin pum...

Страница 91: ...ects coins keys etc 10 2 5 Cartridge and infusion set Caution Your insulin pump has been developed for use with 3 0 ml glass cartridges and Accu Chek infusion sets The cartridge and infusion set are sterile products and intended for single use only Sterility is gua ranteed for unopened packaging up to the indicated expiration date Do not use if package is damaged Do not reuse single use materials ...

Страница 92: ...ss mail Certified mail To operate your insulin pump the temperature of the PowerPack must be 5 C to 40 C 41 F to 104 F Change the PowerPack only in a dry environment To tighten or loosen the PowerPack use only the battery tool supplied with your Accu Chek D TRONplus insulin pump never use coins screw drivers and the like The PowerPack is correctly inserted and tightened when the slot is parallel t...

Страница 93: ...l 3V lithium battery Approx 6 8 weeks depending on delivery rates and frequency of use The time and date as well as the remaining cartridge content are safely stored in the memory for about 1 hour after the PowerPack has been removed or depleted Your insulin pump configuration and settings basal rate active profile automatic off etc and the event memory bolus history history of daily totals histor...

Страница 94: ...s of 0 1 0 2 0 5 and 1 0 units For the scroll and or extended bolus the amount is adjustable in increments of 0 1 units the duration in intervals of 15 minutes 0 4 hr Adjustable in 10 increments 0 90 for decreases 110 200 for increases The duration is adjustable in 1 hour intervals up to a maximum of 24 hours The last programmed duration is given by default for the next temporary basal rate change...

Страница 95: ... oxide Sterilized using radiation Sterilized using antiseptics Date of manufacture Manufacturer Batch number Expiration date Item number SN Serial number Admissible temperature range Admissible humidity range Admissible atmospheric pressure range Fragile handle with care 12 LOT STERILEEO STERILER STERILEA REF kPa Initial diagram during stabilization period Bolus For a bolus of 0 1 U the deviation ...

Страница 96: ... the curve of your personal basal rate profile or profiles Basal rate profile Your insulin pump provides the option of delivering two different basal rate profiles A and B in order to easily meet changing insulin needs for example during the week versus on the weekend A basal rate profile consists of 24 programmed hourly basal rates Bolus The amount of insulin delivered in addition to the basal ra...

Страница 97: ...dified human insulin produced using recombinant DNA technology The onset time of insulin analog is 5 to 15 minutes Daily total The total amount of insulin delivered basal rate and bolus beginning at midnight This amount does not include any insulin needed for the priming of infusion sets Dawn phenomenon The tendency for blood glucose levels to rise early in the morning due to secretion of hormones...

Страница 98: ...eeded initially Type 2 diabetes develops most often in middle aged and older adults but can appear in young people U100 Insulin concentration Each milliliter of liquid contains 100 units of insulin Your Accu Chek D TRONplus insulin pump is intended for the use of short acting insulin U100 and fast acting U100 insulin analogue only Insulin short acting regular insulin Human insulin produced using r...

Страница 99: ...one 44 1273 480444 Fax 44 1273 480266 lewes insulinpumps roche com Australia Roche Diagnostics Australia Pty Ltd 31 Victoria Avenue AU Castle Hill NSW 2154 Phone 61 2 9846 0100 Techn Support 1800 802 409 Orders Fax 1800 066 598 Orders sydney accu chekextra roche com New Zealand Roche Diagnostics N Z Ltd P O Box 62 089 15 Rakino Way Mt Wellington NZ Auckland Phone 64 9 276 4157 Fax 64 9 276 8917 ww...

Страница 100: ...curity 17 Alcohol 157 Alerts 133 A1 Cartridge Low Warning 83 136 A2 Low PowerPack Warning 40 135 137 A3 Set Time Date 51 54 135 137 A4 Cartridge Adapter Alert 55 79 87 136 138 A5 End of Use Time Alert 128 135 143 A6 Temporary Basal Rate Cancelled 89 117 135 143 A7 Temporary Basal Rate Over 117 135 144 A8 Bolus Cancelled 89 94 95 97 100 118 135 144 confirmation 94 136 overview 135 Assistance 1 Auto...

Страница 101: ...147 E4 Occlusion 15 68 80 84 101 103 105 148 E5 End of Use Time 150 E6 Mechanical Error 83 150 E7 Electronic Error 65 151 overview 145 F Filling glass cartridge 73 plastic cartridge 70 Force Sensor 138 148 Functions 36 Basal rates hourly 182 change 64 copy 27 63 program 60 review 65 Battery tool 42 Beeps 24 turn off 21 23 volume 26 120 Blood glucose level high 154 low 157 testing 14 136 138 148 Bo...

Страница 102: ...9 Introduction 9 K KeyLock 34 125 activate deactivate 125 unlock keys 127 Accu Chek D TRONplus insulin pump Reference Manual 199 Accu Chek D TRONplus insulin pump Reference Manual 198 Keys CHECK 27 33 DOWN 27 33 MENU 27 33 pressing 19 26 UP 27 33 L Leakage 155 adapter 138 infusion set 15 cartridge 73 138 luer connection 79 Lock unlock basal rate profile selection 123 basal rate programming 123 Lue...

Страница 103: ...5 W Warnings 3 11 23 Water 162 Plastic cartridge filling 71 preparing 70 Portable phones 17 PowerPack 19 40 177 change 51 insert 49 Precautions 3 14 Priming 80 stop 84 Programming incorrect 10 37 59 109 155 158 Pump therapy 10 interruption 160 continuation 160 R Repair 171 Review basal rate programming 65 bolus history 110 data memory 110 history of alerts and errors 113 history of daily totals 11...

Страница 104: ...Accu Chek D TRONplus insulin pump Reference Manual 202 ...

Страница 105: ...e KeyLock review the remaining time t1 review the remaining time t2 end remaining cartridge content backlight data transfer operating status RUN bolus menu history stop insulin delivery select basal rate profile program basal rate profile A program basal rate profile B program a temporary basal rate history of daily totals history of alerts and errors SETUP menu operating status STOP start insulin...

Страница 106: ... temporary basal rate change is appropriate and program one if necessary A8 Bolus Cancelled Silence and confirm the alert 144 Put your insulin pump into RUN if necessary Ensure that the cancellation was intended and program a new bolus if necessary No Meaning of the error What you have to do Page E1 Empty Cartridge Silence and confirm the error 146 Act according to section 7 2 1 Error E1 Empty Car...

Страница 107: ...rsion in water according to IEC 60529 Symbol for Protection against electric shock Symbol for See instructions in the reference manual Marking of conformity to the European Medical Device Directive MDD Insulin concentration Infrared interface Federal law USA restricts this device to sale by or on order of a physician Always refer to section 7 Alerts and errors for detailed instructions ...

Страница 108: ...g Services Gut zum Druck An Absender Datum Wir bitten Sie dieses Dokument genau zu prüfen und allfällige Korrekturen deutlich anzubringen Für Fehler die in diesem Dokument nicht angegeben sind können wir keine Verantwortung übernehmen Dieses Muster ist nur für Text und Layout massgebend nicht aber für Druck und Papierqualität Unterschrift PM Datum 04543157001 V01 08 04 ACDTpl Reference Manual EN A...

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