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1. Please ensure that the keys on the front of the pump cannot be pressed accidentally especially during the night while you are asleep 3 Please make sure to adjust the timeout interval for the key lock function to your individual needs For children it is recommended to use the minimum timeout interval of 4 seconds This means that the pump will automatically lock itself 4 seconds after an accidental unlocking if no other key has been pressed in the meantime 4 Parents and caregivers should advise children not to press any pump keys Children should be taught to only press the pump keys if a pump operation is required to avoid any unintentional operation of the pump 5 For children and adolescents using the Accu Chek Insight system or users who are concerned that they may activate the Quick Bolus function unintentionally we recommend setting the Quick Bolus increment to the minimum i e 0 1 units These additional instructions provided in this letter will support you in the correct reliable and satisfactory use of their Accu Chek Insight insulin pump system We sincerely apologize for any inconvenience this may have caused you Your national competent authority healthcare professionals distributors and retailers have been informed about this field action Thank you in advance for your understanding and co operation If you need any additional advice on the operation and wearing of the Accu Chek Insight system or have any further questi2. OO Quick Bolus keys other objects in the pocket such as keys coins or phones Such objects could damage the pump or accidentally press the Quick Bolus keys or the aca keys on the front of the pump This could me potentially result in an unintentional bolus delivery or unlocking of the pump Such an accidental operation of the system can be detected by the vibration or acoustic alarm of the pump 2 Please be aware that the key lock function of the Accu Chek Insight insulin pump disengages only the buttons on the front of the insulin pump 3 Please be aware that the automatic key lock function of the pump is programmed to be activated 30 seconds after the last key was pressed This interval can be changed based on your individual needs from 4 up to 60 seconds 4 The Quick Bolus keys on the top of the Accu Chek Insight insulin pump are not disengaged by the activated key lock function To activate the Quick Bolus function one of the keys needs to be pressed for more than 3 seconds The Quick Bolus keys are designed to enable a quick bolus delivery as well as to cancel a bolus in any situation Recommendations for appropriate wearing and operation of the pump 1 Please wear the pump in such a way that the Quick Bolus keys on the top of the pump cannot be pressed accidentally in particular when carrying the pump in a pocket or wearing it under clothing e g do not wear it in a pocket together with a car key coins or other objects 2
3. your customer using the Accu Chek Insight system to wear the pump in such a way that the Quick Bolus keys on the top of the pump cannot be pressed accidentally in particular when they carry the pump in a pocket or wear it under clothing e g do not wear it in a pocket together with a car key coins or other objects 2 Users of the Accu Chek Insight system are advised to ensure that the pump keys on the front of the pump cannot be pressed accidentally especially during the night while they are asleep 3 Users of the Accu Chek Insight system should make sure to adjust the timeout interval for the key lock function to their individual needs For children it is recommended to use the minimum timeout interval of 4 seconds This means that the pump will automatically lock itself 4 seconds after an accidental unlocking if no other key has been pressed in the meantime 4 Parents and caregivers should advise children not to press any pump keys Children should be taught to only press the pump keys if a pump operation is required to avoid any unintentional operation of the pump 5 For children and adolescents using the Accu Chek Insight system or users who are concerned that they may activate the Quick Bolus function unintentionally we recommend setting the Quick Bolus increment to the minimum i e 0 1 units These additional instructions provided in this letter will support people with diabetes in the correct reliable and satisfactory use of thei
4. Consumer Letter Accu Chek Insight Key Lock Urgent field safety notice lt Enter address here gt Location Date Important information on the Accu Chek Insight insulin pump system Update of the handling instructions regarding the Key Lock function Dear Customer please personalize We have recently received feedback from people with diabetes using the Accu Chek Insight system that they experienced an accidental unlocking of the pump keys and an unintentional operation of the system We have immediately investigated this feedback and identified the handling instructions and user manual of the Accu Chek Insight insulin pump to be not detailed enough regarding the description of the key lock function This could potentially be misinterpreted or lead to unintentional accidental operation of the pump Such unintentional operation could potentially result in an under or overdose of insulin and to severe health consequences as e g hyper or hypoglycemia As patient safety is our top priority Roche Diabetes Care has started to enhance the handling instructions for the Accu Chek Insight system with immediate effect In doing so we aim to ensure that every user of the Accu Chek Insight insulin pump knows how to operate and wear the system appropriately These measures will help reduce the risk of an unintentional activation of the pump or accidental insulin delivery Important information 1 Please always prevent any pump contact with
5. ely These measures will help reduce the risk of an unintentional activation of the pump or accidental insulin delivery Important information 1 Please advise your customers using the Accu CO Quick Bolus keys Chek Insight system to always prevent any pump contact with other objects in the pocket such as keys coins or phones Such objects could neta damage the pump or accidentally press the me Quick Bolus keys or the keys on the front of the pump This could potentially result in an unintentional bolus delivery or unlocking of the pump Such an accidental operation of the system can be detected by the vibration or acoustic alarm of the pump 2 Please be aware that the key lock function of the Accu Chek Insight insulin pump disengages only the buttons on the front of the insulin pump 3 Please be aware that the automatic key lock function of the pump is programmed to be activated 30 seconds after the last key was pressed This interval can be changed based on patients individual needs from 4 up to 60 seconds 4 The Quick Bolus keys on the top of the Accu Chek Insight insulin pump are not disengaged by the activated key lock function To activate the Quick Bolus function one of the keys needs to be pressed for more than 3 seconds The Quick Bolus keys are designed to enable a quick bolus delivery as well as to cancel a bolus in any situation Recommendations for appropriate wearing and operation of the pump 1 Please advise
6. ons please do not hesitate to contact our Accu Chek Customer Care line at XXX XXX XXX to obtain a detailed training at any time Kind regards Roche Diabetes Care 2 2 Distributor Retailer Letter Accu Chek Insight Key Lock Urgent field safety notice lt Enter address here gt Location Date Important information on the Accu Chek Insight insulin pump system Update of the handling instructions regarding the Key Lock function Dear Distributor please personalize We have recently received feedback from people with diabetes using the Accu Chek Insight system that they experienced an accidental unlocking of the pump keys and an unintentional operation of the system We have immediately investigated this feedback and identified the handling instructions and user manual of the Accu Chek Insight insulin pump to be not detailed enough regarding the description of the key lock function This could potentially be misinterpreted or lead to unintentional accidental operation of the pump Such unintentional operation could potentially result in an under or overdose of insulin and to severe health consequences as e g hyper or hypoglycemia As patient safety is our top priority Roche Diabetes Care has started to enhance the handling instructions for the Accu Chek Insight system with immediate effect In doing so we aim to ensure that every user of the Accu Chek Insight insulin pump knows how to operate and wear the system appropriat
7. r Accu Chek Insight insulin pump system We sincerely apologize for any inconvenience this may have caused you and your customers This issue is only affecting the Accu Chek Insight system Your national competent authority users of the Accu Chek Insight system and healthcare professionals have been informed about this field action Thank you in advance for your understanding and co operation If you need any additional advice on the operation and wearing of the Accu Chek Insight system or have any further questions please do not hesitate to contact our Accu Chek Customer Care line at XXX XXX XXX to obtain a detailed training at any time Kind regards Roche Diabetes Care 2 3 3 3
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