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Contents

Contents ........................................................................................ i

1 Introduction ............................................................................... 1

1.1 Before you begin .......................................................................... 1
1.2 Indications ................................................................................... 1
1.3 Contraindications ......................................................................... 2
1.4 User Safety ................................................................................... 2

1.5 Warranty Information ................................................................... 9

2 Your A7+ TouchCare® System ................................................... 15

2.1 Personal Diabetes Manager (PDM) ...............................................15
2.2 Patch Pump .................................................................................15
2.3 Glucose Sensing System (Optional) ..............................................16

3 How to use the PDM ................................................................. 19

3.1 Basics of the PDM ........................................................................19

3.1.1 Turn on/off the PDM ................................................................... 19
3.1.2 Charge the PDM .......................................................................... 20
3.1.3 Power Mode ................................................................................ 21
3.1.4 Scroll Bar ..................................................................................... 22

3.2 Setting up the PDM .....................................................................22

3.2.1 Select language and country/region ........................................... 22

B ureau Veritas

Содержание TouchCare A7+

Страница 1: ...B u r e a u V e r i t a s ...

Страница 3: ...ing 8 No 200 Niudun Road Shanghai 201203 China Tel 86 21 50274781 Fax 86 21 50274779 www medtrum com Medtrum B V Nijverheidsweg 17 5683 CJ Best The Netherlands Tel 31 0 499745037 This product complies with Directive 93 42 EEC MDD and Directive 2014 53 EU RED REF SY 018 Version 1 01 Publication date 20 August 2019 UG881116GB 348431 0197 B u r e a u V e r i t a s ...

Страница 4: ...er 7 1 4 6 Storage 7 1 4 7 FCC Caution 8 1 4 8 IC Caution 9 1 5 Warranty Information 9 2 Your A7 TouchCare System 15 2 1 Personal Diabetes Manager PDM 15 2 2 Patch Pump 15 2 3 Glucose Sensing System Optional 16 3 How to use the PDM 19 3 1 Basics of the PDM 19 3 1 1 Turn on off the PDM 19 3 1 2 Charge the PDM 20 3 1 3 Power Mode 21 3 1 4 Scroll Bar 22 3 2 Setting up the PDM 22 3 2 1 Select language...

Страница 5: ...3 2 Pump Status 28 3 3 3 Sensor Status 29 3 3 4 EasyLoop Icon 33 3 3 5 Sensor Graph 34 3 3 6 Alarm Status 35 3 4 Lock Screen 36 3 5 Notification Screen 37 3 6 Shortcut Screen 37 3 7 Status Screen 38 3 8 Menus 40 3 8 1 Bolus 40 3 8 2 Basal 40 3 8 3 Suspend 40 3 8 4 Patch 41 3 8 5 Sensor 41 3 8 6 History 41 3 8 7 Events 41 3 8 8 EasyLoop 41 3 8 9 Settings 41 3 9 Events 41 3 9 1 BG Measurement 42 B u...

Страница 6: ...ory Insulin History 50 3 10 6 2 Summary History Bolus History 50 3 10 6 3 Summary History BG History 50 3 10 6 4 Summary History Sensor History 50 3 10 6 5 Summary History Low Suspend History 50 3 11 Settings 51 3 11 1 CGM System Optional 51 3 11 2 Insulin Pump 51 3 11 3 General Settings 51 3 11 3 1 Language 52 3 11 3 2 Time Date 52 3 11 3 3 Audio Options 53 3 11 3 4 Display 54 3 11 3 5 Confidence...

Страница 7: ...3 4 1 1 3 Enter Pump Base SN 74 4 1 2 Activate a New Reservoir Patch 77 4 1 3 Connect the Pump Base to a New Reservoir Patch 78 4 1 4 Fill the New Reservoir Patch 79 4 1 5 Prime the Pump 82 4 1 6 Select and Prepare the Infusion Site 84 4 1 7 Attach the Patch Pump 86 4 1 8 Start Insulin Delivery 87 4 2 Bolus 89 4 2 1 Normal Bolus 89 4 2 2 Max Bolus 94 4 3 Basal 94 4 3 1 Your Basal Settings 95 4 3 2...

Страница 8: ...ks 115 5 1 2 How to Set up the Bolus Calculator 115 5 1 3 Normal Bolus Using Bolus Calculator 121 5 2 Combo Extended Bolus 124 5 2 1 Combo Extended Bolus Without Bolus Calculator 125 5 2 2 Combo Extended Bolus Using Bolus Calculator 128 5 3 Preset Bolus 131 5 3 1 Preset Bolus Setup 132 5 3 2 Deliver a Preset Bolus 133 5 4 Select a Basal Pattern 134 5 5 Temp Basal 134 5 5 1 Activate a Temp Basal 13...

Страница 9: ...Transmitter 152 6 2 3 Charge the Transmitter 152 6 2 4 Add the Transmitter SN 153 6 2 5 Insert a New Sensor 157 6 2 5 1 Select an Insertion Site 157 6 2 5 2 Prepare the Insertion Site 158 6 2 5 3 Unpack the Glucose Sensor 158 6 2 5 4 Remove the Protective Liner from the Sensor Support Mount 159 6 2 5 5 Locate the Sensor Support Mount 159 6 2 5 6 Remove the Safety Lock 159 6 2 5 7 Insert the Sensor...

Страница 10: ...2 6 5 1 2 Calibration History 174 6 5 1 3 Alert History 175 6 5 2 Summary History Sensor History 175 6 6 Troubleshooting CGM issues 176 7 How to use P LGS Optional 181 7 1 P LGS settings 181 7 1 1 Glucose Alerts 181 7 1 1 1 High Low Limits 182 7 1 1 2 Predictive Alerts 184 7 1 1 3 Rate Alerts 185 7 1 1 4 Repeat 188 7 1 2 Pre Low Suspend 189 7 1 2 1 Low Suspend 189 7 1 2 2 Predictive Low Suspend 19...

Страница 11: ...es 212 8 5 3 CGM reminding messages 213 9 Manufacturer s Declaration 215 9 1 Electromagnetic Emissions 215 9 2 Electromagnetic Immunity 215 10 Appendix I Symbols and Icons 223 10 1 Product Label Symbols 223 10 2 PDM Icons 224 11 Appendix II Technical Information 227 11 1 PDM Specifications 227 11 2 Patch Pump Specifications 227 11 3 Transmitter Specifications 231 11 4 Glucose Sensor Specifications...

Страница 12: ...Before you use different insulin with this Pump check the insulin label to make sure that it can be used with your Pump Use of any insulin with lesser or greater concentration can result in serious injury or even death Your Pump is not intended to deliver any other substance The A7 TouchCare Continuous Glucose Monitoring CGM System incorporates a Glucose Sensor and a Transmitter The Glucose Sensor...

Страница 13: ...ufficient vision and or hearing are required 1 4 User Safety 1 4 1 Warnings and Precautions General Statements Make sure that you have read and are familiar with the User Guide before using the A7 TouchCare System Failure to follow the instructions may result in pain or injury and may also affect the system s performance If you do not understand something or have questions ask your healthcare prov...

Страница 14: ... NOT use the A7 TouchCare System if you have delicate skin or if you are allergic to acrylic adhesives Do NOT use anything other than the accessories specified in this User Guide which could permanently damage your system and voids its warranty Do NOT allow young children to hold the Reservoir Patch Pump Base Transmitter or Sensor without adult supervision The Reservoir Patch Pump Base Transmitter...

Страница 15: ...e meter If the problem continues discard the old Sensor and insert a new one If you suspect your Sensor is broken during usage do NOT attempt to remove it yourself Contact your healthcare provider for assistance in removing the Sensor Personal Diabetes Manager PDM Precautions Your PDM is featured by its color touchscreen Please operate with dry fingers Before you put your PDM in your pocket or pur...

Страница 16: ... Pump Base or Transmitter Use a soft towel Do NOT clean any part of the system while it is in use X rays MRIs and CT Scans The A7 TouchCare System may be affected by strong radiation or magnetic fields If you are going to have an X ray MRI CT scan or other type of exposure to radiation remove your Patch Pump and Glucose Sensing System and put them outside the treatment area with your PDM Change th...

Страница 17: ...try to correct the interference by one of the following measures Move or relocate the A7 TouchCare System Increase the distance between the A7 TouchCare System and the other device that is emitting receiving interference Common consumer electronic devices that transmit in the same frequency band used by the A7 TouchCare System may prevent communication between the PDM and your Patch Pump or Transm...

Страница 18: ...sor including the installed Transmitter to water at depths greater than 2 5 meters 8 feet or for more than 60 minutes Check often to make sure that the devices are securely attached and in place Warning The PDM is protected against insertion of fingers and will not be damaged or become unsafe during a specified test in which it is exposed to vertically dripping water IP22 Warning The Patch Pump ma...

Страница 19: ...y levels between 20 and 90 relative humidity 1 4 7 FCC Caution Labelling requirements This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation Information to user Any Changes or modification...

Страница 20: ...ncluding interference that may cause undesired operation of the device 1 5 Warranty Information Personal Diabetes Manager PDM Medtrum Technologies Inc Medtrum warrants its PDM against defects in materials and workmanship for the period of 4 years from the original date of shipment of the PDM to the original end use purchaser the Warranty Period During the Warranty Period Medtrum will at its discre...

Страница 21: ...ES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE Pump Base Medtrum Technologies Inc Medtrum warrants its Pump Base against defects in materials and workmanship for the period of 1 year from the original date of shipment of the Pump Base to the original end use purchaser the Warranty Period During the Warranty Period Medtrum will at its discretion either repair or replace with a new or re...

Страница 22: ...in materials and workmanship for the period of 1 year from the original date of shipment of the Transmitter to the original end use purchaser the Warranty Period During the Warranty Period Medtrum will at its discretion either repair or replace with a new or recertified Transmitter at Medtrum s discretion any defective Transmitter subject to the conditions and exclusions stated herein This Warrant...

Страница 23: ...r and does not apply to other products or accessories THE REMEDIES PROVIDED FOR IN THIS WARRANTY ARE THE EXCLUSIVE REMEDIES AVAILABLE FOR ANY WARRANT CLAIMS NEITHER MEDTRUM NOR ITS SUPPLIERS OR DISTRIBUTORS SHALL BE LIABLE FOR ANY INCIDENTAL CONSEQUENTIAL OR SPECIAL DAMAGE OF ANY NATURE OR KIND CAUSED BY OR ARISING OUT OF A DEFECT IN THE PRODUCT ALL OTHER WARRANTIES EXPRESSED OR IMPLIED ARE EXCLUD...

Страница 24: ...13 B u r e a u V e r i t a s ...

Страница 25: ...14 B u r e a u V e r i t a s ...

Страница 26: ...basal insulin based on your programmed settings perform safety checks and automatically stop delivery in case of serious conditions The Transmitter can continue to record Sensor glucose readings The PDM is designed to detect and notify you about a disconnection As soon as the problem is solved RF communication will be resumed Personal Diabetes Manager PDM FM 018 2 2 Patch Pump The Patch Pump is a ...

Страница 27: ...System which consists of a disposable Glucose Sensor and a reusable Transmitter The Glucose Sensor is inserted under the skin to measure your glucose level in interstitial fluid The Sensor is the applied part of the Glucose Sensing System The Transmitter records Sensor data and sends data to a display device via wireless RF communication The Transmitter s USB charging cable or charging dock is als...

Страница 28: ...17 Glucose Sensor MD3026 Consumable Transmitter MD1026 Chargeable USB charging cable LQ005 B u r e a u V e r i t a s ...

Страница 29: ...18 B u r e a u V e r i t a s ...

Страница 30: ...u short press the power button a yellow light will go on for about 8 seconds but the PDM is not turned on 2 Turn off When you long press the power button for about 2 seconds the shutdown screen appears Then you can slide to power off a yellow light will last for about 6 seconds indicating that the shutdown is completed Or you long press the power button for about 6 seconds a yellow light will go o...

Страница 31: ...not work normally You must charge the PDM when the battery is low to keep using the PDM If the battery is exhausted the PDM will shut down automatically No settings will be lost if the PDM power is depleted or PDM error happens The battery must be fully charged the first time you use the PDM which usually takes around 2 hours If the battery is not full after 12 hours of continuous charging as requ...

Страница 32: ... changed b The screen will be locked after screen backlight timeout c Press Power button and the screen lights up the PDM displays the Lock Screen 2 Awake Mode The PDM is in the Awake Mode when the screen backlight stays on a You can turn Sleep Mode to Awake Mode by pressing power button b In the Sleep Mode all Alerts and Alarms regarding the Pump and CGM will immediately wake the screen to enter ...

Страница 33: ... Scroll Bar If there is excessive text length for the screen a scroll bar appears on the right side of the screen You can view any additional text by scrolling up and down 3 2 Setting up the PDM 3 2 1 Select language and country region 1 Select your language then tap Next B u r e a u V e r i t a s ...

Страница 34: ...tarting PDM for the first time you need to set the time and date Setting the correct time and date in your PDM is necessary for accurate basal insulin delivery and enables you to keep a correct record of your insulin delivery and Sensor readings You can select a 12 hour or 24 hour clock format 1 Select your time then tap Next B u r e a u V e r i t a s ...

Страница 35: ... right 3 When finish tap Done 2 Select the Date then tap Next 1 Choose the date 2 Adjust the day month and year separately 3 When finish tap Done 3 2 3 Bolus Calculator After you finish the settings for date and time you can choose whether you shall use the Bolus Calculator Tap Setup to enter Bolus Calc Setup Tap Skip to go B u r e a u V e r i t a s ...

Страница 36: ...Home Screen The Home Screen is the starting point to access the programming screens You can return to the Home Screen by tapping the Home Key The first line shows status bar icons including PDM Battery Alert Alarm Time Audio Vibration Pump RF Signal You can find on the main interface icons including Calibration IOB Insulin on Board EasyLoop Icon Insulin left and your real time Insulin Pump Deliver...

Страница 37: ...ting different battery conditions You need to charge PDM when the battery icon turns red At least 80 left At least 60 left At least 20 left At least 10 left No battery left When the PDM is charging There are six icons indicating different battery conditions Less than 10 charged At least 10 charged At least 20 charged At least 60 charged At least 80 charged Fully charged 3 3 1 2 Time Icon You can s...

Страница 38: ... icon appears only when there is an active Patch Pump Patch Pump is active and RF communication is good Patch Pump is active but RF communication is lost or interrupted 3 3 1 5 Alert Icons A yellow triangle with one yellow exclamatory mark alert a red triangle with two red exclamatory mark medium priority alarm or a red triangle with three red exclamatory mark high priority alarm appears only when...

Страница 39: ...Green ring represents the basal delivery Green and dark green ring Green ring with dark green part represents Temp Basal the dark green part indicates the progress of Temp Basal delivery Blue and dark blue ring Blue ring represents the Normal Bolus the dark blue part indicates the progress of delivery 1 EasyLoop Icon 2 Insulin Pump Delivering Status 3 IOB Insulin on Board 4 Pump RF Signal 5 Insuli...

Страница 40: ...ormal Bolus is active and 1 00U of bolus delivered total bolus programmed 2 00U Extended U 1 00 2 00 Extended Bolus is active and 1 00U of bolus delivered total bolus programmed 2 00U C Normal U 1 00 2 00 Normal Bolus of Combo Bolus is active and 1 00U of Normal Bolus delivered total Normal Bolus programmed 2 00U C Ext U 1 00 2 00 Extended Bolus of Combo Bolus is active and 1 00U of Extended Bolus...

Страница 41: ...alibration Icon If your Sensor is on a 24 hour calibration routine the calibration icon grows fuller as the time for the next calibration 1 Trend Arrow 2 The last senor reading or status 3 Time of the last sensor reading 4 The scope of glucose limit 5 High Limit of glucose limit 6 Low Limit of glucose limit 7 CGM Curve 8 Last Glucose point 9 The scope of time 10 Calibration B u r e a u V e r i t a...

Страница 42: ...ion is needed now If your Sensor is on a 12 hour calibration routine the calibration icon grows fuller as the time for the next calibration The next calibration is due in 10 to 12 hours The next calibration is due in 8 to 10 hours The next calibration is due in 6 to 8 hours The next calibration is due in 4 to 6 hours The next calibration is due in 2 to 4 hours The next calibration is due in 0 to 2...

Страница 43: ...cent glucose reading is displayed at the center of the ring on the Home Screen Under certain conditions the Sensor reading will be replaced by a Sensor status in the middle of the ring Warm Up the Sensor is warming up ERR the Sensor shall be recalibrated after 15 minutes BG the Sensor shall be recalibrated now No readings LOST Sensor signal has been lost for more than 10 minutes High Sensor glucos...

Страница 44: ...Loop Icon When you turn on Low Suspend or Predict Low switch in EasyLoop Menu the system will be on EasyLoop Icon Mode The Patch Pump will perform safety checks and automatically stop delivery when the CGM reading triggers the suspend function There are two kinds of EasyLoop Icon If Low Suspend or Predict Low happens in different situations the screen shows different icons It will appear when Low ...

Страница 45: ...st 3 hour 6 hour 12 hour and 24 hour periods Tap the Sensor graph and move the cursor to spot the glucose values Use the left and right arrow button to choose the time The time interval between two values is 2 minutes The time point when a new Sensor is applied will be marked with a green square tag Readings during warm up phase will not be displayed but marked as warm up Glucose value or special ...

Страница 46: ... Home Screen When data is being recovered after sensor reconnection you cannot enter landscape screen by long pressing the graph When you are only using the insulin pump as stand alone system the sensor graph displays the blood glucose recorded and BG inputs will be displayed as red dots 3 3 6 Alarm Status Some Alarm status remains even after the alarm is cleared The following alarms will be displ...

Страница 47: ...r username and telephone number See Username and Telephone in Section Settings for more information The PDM displays the Lock Screen after display timeout When the screen s gone dark short press the Power button to activate the Lock Screen 1 Lock Screen without Alarm Alert and Reminder See Pump Status for more information about delivering status 2 Lock Screen when Alarm Alert and Reminder occurs B...

Страница 48: ...fication Screen 1 If there is no daily Alert and Alarm notification the screen displays No Record 2 If there is Alert and Alarm notification only the still existing Notifications will be displayed 3 The latest notifications will be displayed on top 3 6 Shortcut Screen Shortcut Screen grants you quick access to a few settings including Bolus Calibration Audio Vibration and Brightness You can slide ...

Страница 49: ...dio off High volume 4 Vibration Option icon There are two icons of Vibration Option each changing after one tap Vibration off Vibration on 5 Brightness adjustment icon There are ten brightness levels which are increased from left to right 3 7 Status Screen The Status Screen lists the system s current operating status Slide from left to right on the Home Screen to open the Status Screen Slide from ...

Страница 50: ...39 The Status Screen displays the following information Delivery Today Bolus Basal Other Status Info Device Info B u r e a u V e r i t a s ...

Страница 51: ...ettings and functions for bolus deliveries See Section Bolus in Chapter How to use Patch Pump for more bolus information and Chapter Advanced Pump Features for advanced bolus settings 3 8 2 Basal On Basal menu you can deliver temp basal insulin select and view different basal pattern See Chapter How to use Patch Pump and Chapter Advanced Pump Features for more information 3 8 3 Suspend When no Bol...

Страница 52: ...u can review Pump History Sensor History PDM History Event History BG History and Summary History See Section History in this chapter for more information 3 8 7 Events The Events screen helps you record different events including blood glucose insulin injection carbohydrates exercise health and other information See Section Events in this chapter for more information 3 8 8 EasyLoop The EasyLoop me...

Страница 53: ... Menu Events 3 9 1 BG Measurement 1 Select BG Type in the Events screen 2 Choose the date and time for BG event Note The time refers to blood sampling time 3 You can choose between BG and Lab Measurements in the Method option Note Lab is referred to as venous blood glucose tested in laboratory 4 Tap BG to enter BG in the BG row the default blood glucose is 120 mg dL or 6 5 mmol L The input range i...

Страница 54: ...ion 3 Tap Type option you can choose the insulin type between Rapid acting Intermediate acting Long acting Pre mixed and unselected 4 Tap Dose value to select the amount of insulin you use The input range is 0 1 99 units 5 When finished tap Save to confirm input Or press to cancel 3 9 3 Carbohydrates Information 1 Select Carbs in the Events screen B u r e a u V e r i t a s ...

Страница 55: ...ation 1 Select Exercise in the Events screen 2 Choose the date and time for physical exercise 3 Tap Intensity option to select the intensity of physical exercise You can choose the intensity between Light Medium and Heavy 4 Tap Duration value to select the duration of exercise The input range is 5 minutes 8 hours the input increment is 5 minutes 5 When finished tap Save to confirm input Or press t...

Страница 56: ...choose the intensity between Illness Stress High Symptoms Low Symptoms Menstruation and Alcohol 4 When finished tap Save to confirm input Or press to cancel 3 9 6 Other Events This section shows how to enter other markers 1 Select Others in the Events screen 2 Choose the date and time for other events 3 Tap Note text to enter other event information B u r e a u V e r i t a s ...

Страница 57: ...te Use no more than 22 characters to describe an event 5 When finished tap Save to confirm input Or press to cancel 3 10 History Your PDM stores insulin delivery history Sensor history PDM history Event history BG history and Summary history to help you manage diabetes Go to the History screen Main Menu History B u r e a u V e r i t a s ...

Страница 58: ... Features for more information 3 10 2 Sensor History On the Sensor History menu you can review Sensor History See Section Sensor History in Chapter How to use CGM system for more information 3 10 3 PDM Alert History PDM History stores PDM Alert history Main Menu History PDM History PDM Alert History B u r e a u V e r i t a s ...

Страница 59: ... alerts and the meanings of different alarm alert icons 3 10 4 Event History Go to the Event History screen Main Menu History Event History Tap Type option to select event type for viewing records accordingly Tap the date or to switch between records of different dates Select an event record to view the details 3 10 5 BG History Go to the BG History screen Main Menu History BG History B u r e a u ...

Страница 60: ...ary History displays a summary of past histories including Insulin History Bolus History BG history Sensor History and Low Suspend History Go to Summary History screen Main Menu History Summary History On the top right of each summary screen select 1 day to view the history data for a single day or select multiple days 7 14 30 days to view an average result on the selected days B u r e a u V e r i...

Страница 61: ... history Main Menu History Summary History BG BG Test Total number of BG readings entered manually on the selected days Average BG Average BG readings on the selected days High BG Highest BG reading on the selected days Low BG Lowest BG reading on the selected days 3 10 6 4 Summary History Sensor History See Section Sensor History in Chapter How to use CGM system for more information 3 10 6 5 Summ...

Страница 62: ...xpiration alert on or off See Chapter How to use CGM system for more information 3 11 2 Insulin Pump Tap Insulin Pump on the Settings screen to enter the Insulin Pump screen You can set your Insulin Pump in Insulin Pump Screen See Chapter How to use Patch Pump and Chapter Advanced Pump Features for more information 3 11 3 General Settings The General Settings menu contains Language Time Date Audio...

Страница 63: ...er events You can select a 12 hour or 24 hour clock Occasionally when you need to change the date and time settings for example to adjust for daylight saving time or after resetting the PDM change the old Reservoir Patch and activate a new patch disconnect the Sensor and reconnect it Note As a safety feature you can only change the date and time when there is no active Reservoir Patch or connected...

Страница 64: ... one of the four audio options for your alerts and alarms audio vibrate audio and vibrate or both off The factory setting is audio and vibrate Your choice applies to both your PDM and Patch Pump If Audio is selected both your PDM and Patch Pump will beep when an alert occurs If Vibrate is selected both your PDM and Patch Pump will vibrate when an alert occurs B u r e a u V e r i t a s ...

Страница 65: ...PDM emits three pulse vibration every three minutes If not cleared within 9 minutes your PDM will make a siren until the alert is cleared See Audio Icons for significance of different audio icons See Chapter Safety System and Alarms Alerts for more information Go to Audio Options screen Main Menu Settings General Audio Options 3 11 3 4 Display You can set your screen display time between 30 sec 1 ...

Страница 66: ...ding The beginning and end of a bolus The beginning and end of a temp basal Basal pattern changed Basal edit completed Suspend alarm setting takes effect Max delivery setting takes effect Sensor connected Insulin delivery has been suspended Basal insulin has been resumed Glucose alert set Pump alert alarm set Tapping the HOME key 3 11 3 6 User Settings You can use this feature to save restore or r...

Страница 67: ... Settings will be disabled Save Take these steps to save your current PDM settings 1 Select Save in the User Settings screen 2 If this is the first time saving your PDM settings this screen appears If you have saved PDM settings this screen appears B u r e a u V e r i t a s ...

Страница 68: ...creen indicates that your user settings have been saved Restore Take these steps to restore the most recent PDM settings you have saved to your PDM 1 Select Restore in User Settings screen 2 Read the instructions on the screen and then tap OK to restore the settings B u r e a u V e r i t a s ...

Страница 69: ...o NOT reset your PDM settings unless directed by your healthcare provider If you reset your PDM settings it will be necessary to reprogram all your personal PDM settings as directed by your healthcare provider Take the following steps to reset PDM settings 1 Select Reset in the User Settings screen Then select Yes B u r e a u V e r i t a s ...

Страница 70: ...gs and restart Settings History On this screen you can review all recent user settings operation records and the date and time 1 Select Settings History in User Settings screen 2 Slide to scroll up down to view the entire settings history B u r e a u V e r i t a s ...

Страница 71: ...The passcode lock function is a safety feature that prevents improper operation by unintended user Main Menu Settings General Passcode Lock Tap Set Passcode enter the old passcode and then set a new one B u r e a u V e r i t a s ...

Страница 72: ...61 Enter the 4 digit passcode Note The default passcode is 0000 Enter the new passcode twice B u r e a u V e r i t a s ...

Страница 73: ...r you slide to unlock the PDM Once you unlock the PDM the Passcode Lock is automatically deactivated 3 11 4 Reminders Tap Reminders on the Settings to enter the Reminders screen 3 11 4 1 Personal Reminder The factory setting for this feature is off The personal Reminders can be useful to remind you when to check your blood glucose eat bolus etc You can add delete or review Reminders when the Perso...

Страница 74: ...er Tap Add Reminder to add a reminder choose the time and tap Done Note 1 You can set up to 4 Reminders 2 The Reminders will be saved automatically Slide from right to left on one reminder tap Delete to delete this segment B u r e a u V e r i t a s ...

Страница 75: ...minder See Section Reminder in Chapter Advanced Pump Features for more information 3 11 4 4 Cal Reminder See Section Calibration Reminder in Chapter How to use CGM system for more information 3 11 5 Username 1 Go to the Username screen Main Menu Settings Username 2 Tap to enter your username B u r e a u V e r i t a s ...

Страница 76: ...e You can enter as many as 18 letters including spaces Your username will be displayed on the Lock Screen The PDM displays the username on Lock Screen to help you identify your own PDM You can always confirm that the username is correct before using the PDM 3 11 6 Telephone 1 Go to the Telephone screen Main Menu Settings Telephone 2 Tap to enter your telephone number or emergency call number B u r...

Страница 77: ...elephone number on Lock Screen which works in two optional ways 1 to help you find your PDM if your PDM is lost 2 to display your emergency call number family members doctor healthcare center 3 11 7 Diagnostics The function Diagnostics helps you check if the PDM beeps and vibrates properly 1 Go to the Diagnostics screen Main Menu Settings Diagnostics 2 Select Diagnostics then tap Next B u r e a u ...

Страница 78: ...67 3 The PDM will beep three times and vibrate one time while the screen suggests checking alarms 4 When checking is completed tap OK to return to the last menu B u r e a u V e r i t a s ...

Страница 79: ... SN PDM program version and code 3 12 Troubleshooting This section contains procedures and information to help you understand and address conditions that might occur with A7 TouchCare System It will give a simple analysis and some detailed answers please look for it in the corresponding sections What protocol does the A7 TouchCare System use to communicate The Bluetooth protocol Bluetooth Low Ener...

Страница 80: ...W alert happens PDM does not power on after you press the Power button 1 PDM battery is too low Charge the PDM 2 PDM is outside of its operating temperature range Move the PDM to a temperature between 5 C 40 C and then try to power it on B u r e a u V e r i t a s ...

Страница 81: ...70 B u r e a u V e r i t a s ...

Страница 82: ...ap and water 2 clean the insulin vial with an alcohol wipe 3 clean the infusion site with an alcohol wipe 4 keep sterile items away from any possible germs Warning Always check BG one to two hours after changing the Reservoir Patch Remember to check the insulin level in your Reservoir Patch two hours before going to sleep Change the Reservoir Patch if it doesn t have enough insulin to cover your n...

Страница 83: ...been deactivated properly may continue to deliver insulin as programmed putting you at risk of over infusion and possible hypoglycemia Do NOT apply a new Reservoir Patch before you have deactivated and removed the old Reservoir Patch 4 1 1 1 Deactivate the Current Reservoir Patch Warning You must deactivate the current Reservoir Patch before you remove it from your body and disconnect the Pump Bas...

Страница 84: ...rrent Reservoir Patch 1 After the Reservoir Patch is deactivated press the needle release button on the side of the Reservoir Patch and slide it to the direction of the arrow to retract the needle Gently lift the edge of the adhesive tape from your skin and remove the entire Reservoir Patch B u r e a u V e r i t a s ...

Страница 85: ...scard the old Reservoir Patch according to your local waste disposal regulations Warning Do NOT discard your Pump Base It is reusable 4 1 1 3 Enter Pump Base SN Before activating a new patch make sure that the pump Base serial number has been entered into your PDM Main Menu Patch Pump Base SN Note Don t forget to update the SN if you change to a new Pump Base Note You can only change the Pump Base...

Страница 86: ...N if it is the first time you enter the SN 2 You can only enter SN manually if you want to update the SN Enter SN manually Tap or the existing Pump base SN you will see the following screen Then enter the SN to your PDM and tap Done B u r e a u V e r i t a s ...

Страница 87: ...at your Pump Base is connected to a new Reservoir Patch and move the PDM closer to your Pump before searching for the SN See Section Connect the Pump Base to a New Reservoir Patch for more information If your PDM finds one Pump the Pump Base SN appears on the screen Check if it matches the SN printed on your Pump Base If it is correct tap OK B u r e a u V e r i t a s ...

Страница 88: ...your Pump Base is connected to a new Reservoir Patch move the PDM closer to your Pump and search again or enter the SN manually 4 1 2 Activate a New Reservoir Patch When there is no old Patch activated or when the old Patch has been removed you can go to Patch Menu to activate a new patch Make sure that the pump Base serial number has been entered into your PDM correctly Main Menu Patch New Patch ...

Страница 89: ...ts sterile package has been damaged or already opened or if the Reservoir Patch has expired or if the Reservoir Patch is damaged in any possible way 2 Place your thumb and index finger on the Pump Base Hold the new Reservoir Patch with your other hand Insert the hooks and connecter on the Reservoir Patch all the way into the slots of the Pump Base B u r e a u V e r i t a s ...

Страница 90: ...ing If your insulin is stored in the refrigerator wait until the insulin reaches room temperature before you fill the reservoir Using cold insulin could produce air bubbles in the reservoir While filling the reservoir be sure to remove air bubbles Warning When you are filling the Reservoir Patch make sure that it is at least 30 cm 12 inches from any magnetic objects such as magnets mobile phones a...

Страница 91: ...yringe Slowly push up on the plunger just enough to remove air bubbles from the syringe Warning Avoid using insulin from more than one vial because this may introduce air into the syringe 7 With the vial down hold the syringe Pull straight up to remove the syringe needle from the vial and then insert it perpendicularly into the insulin fill port on the side of the Reservoir Patch Warning Make sure...

Страница 92: ...n the syringe upright and pull on the plunger Flick the syringe to make sure that any air bubbles rise to the top Gently press on the plunger to remove air bubbles until insulin fills the needle hub and you see a drop of insulin at the tip of the needle 11 Re insert the needle in the fill port and slowly fill the reservoir with insulin It is normal to feel some back pressure as you slowly press on...

Страница 93: ...sulin Reservoir Patch shall be used soon after being filled with insulin 13 After you fill the Reservoir Patch Press OK to continue Note Call customer support if you have filled the Reservoir Patch with more than 70 units but the reservoir volume icon is still empty Note After filling the Reservoir Patch with insulin you should change the Reservoir Patch within 3 hours To Reminder that the Reservo...

Страница 94: ...t of the button cover all the way until you hear a click indicating the needle button is locked in place by the two hooks on the button cover Warning Do not start priming before the top square part of the button cover is fully pressed After that tap Next on your PDM to prime the Pump B u r e a u V e r i t a s ...

Страница 95: ...ing the Pump may put your health at risk 4 1 6 Select and Prepare the Infusion Site The place on your body where you attach the Pump is important for the success of your therapy Discuss the best infusion sites with your healthcare provider When choosing the location for the Pump consider the following You can comfortably reach the Pump You apply the Pump to a flat area of skin with adequate subcut...

Страница 96: ...tes Front Back Front Back Adult Youth If you choose an infusion site on your abdomen hip back or buttocks apply the Patch Pump horizontally If you choose an infusion site on your upper arm or thigh apply the Patch Pump vertically Warning Change the site each time you apply a new Reservoir Patch Be sure to rotate the infusion sites so that they are not overused A new infusion site should be at leas...

Страница 97: ...er from the bottom of the Reservoir Patch Remove the liner and expose the adhesive 3 Avoid touching the stickiness of the adhesive pad press the Pump against the skin at the selected infusion site 4 Hold your Pump in place for 5 10 seconds Run your finger around the entire edge of the adhesive pad to make sure that it is securely attached to your body B u r e a u V e r i t a s ...

Страница 98: ...tion creams or oil near the infusion site because it may loosen the adhesive Note The adhesive is designed for one time use Once removed a Reservoir Patch cannot be reapplied 4 1 8 Start Insulin Delivery 1 Press the needle button with one quick motion to completely insert the needle below your skin until the button locks in place 2 Press Next after you insert the needle and the following screen ap...

Страница 99: ... the needle then the PDM will instruct you to discard the Reservoir Patch Warning You should check the area around the Reservoir Patch at regular intervals for possible redness irritation and inflammation If you find infection immediately remove the Reservoir Patch and apply a new one in a different location 4 Now your new Reservoir Patch is activated Warning Do NOT disconnect the Pump Base from t...

Страница 100: ...Care System provides three bolus types Normal Bolus Extended Bolus and Combo Bolus This section gives instructions for a Normal Bolus See Chapter Advanced Pump Features for more information about Extended Bolus and Combo Bolus Go to the Bolus screen Main Menu Bolus Note When the Bolus Calculator is switched off in the Settings Bolus Calculator will not appear in the Bolus menu See Chapter Advanced...

Страница 101: ...90 2 Set your bolus amount 3 Select Normal Bolus type Bolus type is Normal Bolus Extended Bolus or Combo Bolus 4 Tap Next to confirm if the bolus setting is correct B u r e a u V e r i t a s ...

Страница 102: ...Reminder in Chapter Advanced Pump Features for more information 5 Slide to deliver the bolus As the Normal Bolus is being delivered the amount shown on the screen will add up to the actual bolus amount which is delivered Note As the bolus is being delivered you can tap Home Key to return to the Home Screen The circular progress bar indicating that a bolus is being delivered is displayed on the Hom...

Страница 103: ...rted Slide to Stop to cancel the bolus An on screen message will tell you how much insulin has been delivered Tap OK to go back to the Home Screen 7 If the delivery value given exceeds the remaining insulin amount in the Reservoir the screen will show the following reminder B u r e a u V e r i t a s ...

Страница 104: ...30 minutes has already exceeded 10 U the screen will show the following reminder 9 If connection between PDM and Pump failed during delivery the screen shows Checking Pump status the delivery cannot be cancelled B u r e a u V e r i t a s ...

Страница 105: ... maximum bolus with the help of your diabetes team Go to the Max Bolus screen to set the max bolus Main Menu Settings Insulin Pump Bolus Setup Max Bolus 4 3 Basal Basal rate is the rate at which your Patch Pump infuses small doses of insulin to cover your body s insulin needs between meals Basal rates usually take up about 50 of the total daily dose TDD of insulin A basal pattern contains at least...

Страница 106: ...ork and menstruation Standard Your normal basal pattern that supports your usual day to day activity Exercise Your exercise basal pattern that supports your exercise activity Holiday Your holiday basal pattern that supports your holiday activity Sick Your sick basal pattern that supports your sick day activity Pattern A B C D Basal patterns for you to define such as menstruation etc We recommend t...

Страница 107: ...n Menu Settings Insulin Pump Basal Setup Edit Basal 1 Select the Standard pattern to edit it Note The active basal pattern is check marked Select the desired pattern and slide to activate it Note As a safety feature the system suspends basal delivery when you are editing an active basal pattern and resumes delivery after the editing is done When a temporary basal is in process the check marked pat...

Страница 108: ...can start since each hour or each half hour The end time point of the last time segment is always set to be midnight Tap Add time segment to create and edit a new segment 3 Tap blue font of the U H field to set a desired basal rate value Then tap Done Note You can set a basal rate between 0 and the Max Basal Rate with an increment of 0 05 U H 4 When finished tap to save the basal setup and return ...

Страница 109: ...appears automatically Set your basal segments as recommended by your healthcare provider 4 3 3 Check the Current Basal Rate The Home Screen and the Status Screen show the information of the current basal rate 1 Home Screen 2 Status Basal 24 Hour Total B u r e a u V e r i t a s ...

Страница 110: ...reen shows your daily basal rates of all patterns 1 Go to the Basal Review screen Main Menu Settings Insulin Pump Basal Setup Basal Review 2 Choose the basal pattern that you want to review Tap it to review your programmed settings B u r e a u V e r i t a s ...

Страница 111: ...the starting time of all segments cannot be changed 2 After the selected segment is deleted the starting time of the next segment following the deleted segment will change to the ending time of the last segment before the deleted one The same when you delete more than one segment 3 When the first segment is deleted the starting time of the previous second segment now the new first segment becomes ...

Страница 112: ... time point B will be deleted leaving only the edited segment featuring a period between its original starting time point and ending time point B The ending time Point B equals to the starting time point of the segment that follows As for the Basal rate when not edited the Basal rate of the previous segment covers the Basal rate of the segment in the same period or with overlapping period after ed...

Страница 113: ...gment featuring a period between its original starting time point and ending time point A The ending time Point A equals to the starting time point of the segment that follows As for the Basal rate when not edited the Basal rate of the previous segment covers the Basal rate of the segment in the same period or with overlapping period after editing Example the ending time point of the third segment...

Страница 114: ...r basal rates have been set you cannot set a maximum basal rate that is less than any of the programmed basal rates The factory default is 2 00 U H The setting range is 0 00U H 25U H Please set the maximum basal rate with the help of your healthcare provider 1 Go to the Max Basal screen Main Menu Settings Insulin Pump Basal Setup Max Basal 2 You can modify max basal rate by using the number keyboa...

Страница 115: ...uspend all insulin deliveries basal and bolus for a set period of time or to just stop the bolus currently being delivered a When no bolus is being delivered 1 Go to the Suspend screen Set a suspension time and tap Next to continue Main Menu Suspend Note You can set the suspension time between 15 min and 2 hours with an increment of 15 min 2 The following message will appear Slide to suspend if yo...

Страница 116: ...y Bolus and Temp Basal will be canceled and cannot be resumed 3 The PDM will give an on screen message to let you know that insulin delivery is indeed suspended 4 The remaining suspend time can be found on Home Screen B u r e a u V e r i t a s ...

Страница 117: ... the bolus Main Menu Suspend 2 If you select All the same to the situation when no bolus is being delivered The feature can stop all insulin 3 If you select Bolus the delivery status of respectively a Normal or an Extended Bolus will show following screen Slide to stop to stop bolus insulin B u r e a u V e r i t a s ...

Страница 118: ...olus Stop Extended Bolus 4 4 2 Resume Insulin Delivery After all insulin delivery is suspended Tap Resume on the Main Menu screen and the following screen appears Slide to resume Basal delivery B u r e a u V e r i t a s ...

Страница 119: ...et Basal Setup and set Pump Alerts 4 5 1 Add Change the Pump Base SN Every time you use a new Pump Base you need to add the Pump Base SN to your PDM Your PDM and Pump Base will connect automatically after each Reservoir Patch change process Tap Settings on the Main Menu to enter the Settings screen Tap Insulin Pump to enter the Pump Settings screen Turn the insulin pump feature on B u r e a u V e ...

Страница 120: ...and Max Bolus in the Bolus Setup 1 Bolus Calculator See Chapter Advanced Pump Features for more information Consult your healthcare provider before changing this setting 2 Preset Bolus Setup See Section Preset Bolus for more information You can set up to seven preset bolus amounts Breakfast Lunch Dinner Snack Bolus 1 Bolus 2 and Bolus 3 3 Max Bolus The maximum bolus Max Bolus is a safety feature t...

Страница 121: ...eset Temp Basal in Chapter Advanced Pump Features for more information You can set up to seven preset temp basal rates Heavy Ex Medium Ex Light Ex Sick Temp 1 Temp 2 and Temp 3 4 Max Basal See Section Basal in Chapter How to use Patch Pump for more information Maximum Max basal rate is a safety limit for the amount of basal insulin to be delivered within an hour This maximum rate applies to every ...

Страница 122: ...s every hour until the system automatically deactivates the current Reservoir Patch after 80 hours use You can set the PATCH EXP ADVISORY Alert period from 2 hours to 24 hours before expiration 2 Low Reservoir The LOW RESERVOIR Alert allows you to program the PDM to give an alert when insulin in the Reservoir Patch reaches a certain level so you can plan ahead to change the Reservoir Patch You can...

Страница 123: ...ve an alarm if you may have delivered excessive insulin in the past hour or within one day There are two types of delivery limit that you can set hour max and daily max The factory setting for hour max is 25 U and for daily max is 80 U You may choose to program this feature into your PDM based on the amount of units you usually deliver in 1 hour and within 1 day Discuss what settings are best with...

Страница 124: ...tch Pump status in a set number of hours Obtain Patch Pump status by pressing any button on your PDM This feature can be used as a safeguard in case you are unable to operate your PDM for example being unconscious The factory setting for this feature is off You may choose to program this feature into your PDM based on the number of hours that you usually sleep Discuss what functions and settings a...

Страница 125: ...114 B u r e a u V e r i t a s ...

Страница 126: ...ll provide a suggested bolus for you Note As a safety feature the system only allows you to give a bolus at or below the maximum bolus limit you have set See Chapter How to use Patch Pump for more information on resetting your maximum bolus limit Consult your healthcare provider before changing this setting 5 1 2 How to Set up the Bolus Calculator You can do your personal settings in the bolus cal...

Страница 127: ... amount of carbs you can cover with one unit of insulin Because this ratio may vary throughout the day you can program up to eight I C ratios Your healthcare provider may only have you program one or two carb ratios when you first start using the bolus calculator feature Note If you set only one Insulin to Carb ratio it will be used for the entire 24 hour period In the Bolus Calc Setup screen sele...

Страница 128: ...g the increment is 1 g 2 Tap Add time segment to create a new segment Note Add time segments by choosing from 00 30 23 30 or 12 30A 11 30P with an increment of 00 30 Note If Add time segment does not appear you have programmed all possible segments 3 Continue to set ratio segments as recommended by your healthcare provider Note Select segment slide to left on each and a delete button will appear T...

Страница 129: ...when you first start using the bolus calculator feature Note If you only set one insulin sensitivity factor it will be used for the entire 24 hour period In the Bolus Calculator Setup screen select Insulin Sensitivity 1 The first segment always starts at midnight The BG field is indicated by the blue editable digit Note You can set the BG between 0 5 mmol L and 22 2 mmol L 10 mg dL and 400 mg dL w...

Страница 130: ...out the day you can set up to eight BG targets If you want to set just one target value instead of a range set both the low and high values to the same number If your current BG is above the BG Target Range the bolus calculator feature will calculate a correction dose If your current BG is below the BG Target Range the bolus calculator will calculate a negative correction and thus subtract it from...

Страница 131: ...ossible segments 3 Continue to set the BG Target segments as recommended by your healthcare provider Note Select segment slide to left on each and a delete button will appear Tap Delete to delete the selected segment The first segment cannot be deleted and the starting time of first segment cannot be changed 4 When finished press to exit the edit mode and press to save settings IOB Time B u r e a ...

Страница 132: ...he amount of IOB to subtract before estimating a bolus Please set the IOB time with the help of your healthcare provider In the Bolus Calculator screen select IOB Time and edit it Note You can set the IOB Time between 2h and 8h with an increment of 0 5h The factory default is 3 Hours 03 00 5 1 3 Normal Bolus Using Bolus Calculator After the bolus calculator is turned on and programmed this feature...

Страница 133: ...n estimate of insulin for your food entry without considering your BG level 2 You can enter a BG value between 1 1 mmol L and 33 3 mmol L 20 mg dL and 600 mg dL with an increment of 0 1 mmol L 1 mg dL The factory default is 5 6 mmol L 100 mg dL 3 You can enter an amount of carbs between 0 g and 300 g with an increment of 1 g 4 You can set a bolus dose between 0 and the Max Bolus with an increment ...

Страница 134: ...The following screen appears with the calculated bolus amount You can adjust the recommended Bolus amount for the Set Bolus as needed Then choose the Bolus type and tap Next Note The BG Reminder screen will appear if you have BG Reminder turned on You can accept or modify the time before you are reminded to check your blood glucose after a bolus B u r e a u V e r i t a s ...

Страница 135: ...ne that is currently being delivered even after insulin delivery has started Slide to Stop to cancel the bolus 5 2 Combo Extended Bolus The Combo Extended Bolus feature is useful for consumption of high carb high fat meals such as pizza which entails prolonged carb absorption It is also useful if you will be eating grazing over a few hours or if you have gastroparesis which means food remains in t...

Страница 136: ...ns of your PDM before exploring these options 5 2 1 Combo Extended Bolus Without Bolus Calculator 1 Calculate your food and or correction bolus amount 2 In the Bolus Menu screen select Manual Bolus Extended Bolus To set an Extended Bolus follow these steps a Tap Set Bolus value to enter the desired amount for Extended Bolus units and tap Next Note You can set a bolus dose between 0 and the Max Bol...

Страница 137: ... will be displayed then Slide to deliver to start delivery Note The BG Reminder screen will appear if you have BG Reminder turned on You can accept or modify the time before you are reminded to check your blood glucose after a bolus See BG Reminder in this chapter for more information Combo Bolus To set a Combo Bolus follow these steps a Select Set Bolus value to enter the desired amount for Combo...

Страница 138: ...olus Tap the purple icon to increase Extended part d Enter the amount of time you want the Extended Bolus to last and tap Next to continue Note You can set the duration between 30 min and 8h with an increment of 30 min Note The BG Reminder screen will appear if you have BG Reminder turned on You can accept or modify the time before you are reminded to check your blood glucose after a bolus See BG ...

Страница 139: ... carb intake The bolus calculator feature will use this input to calculate your suggested bolus amount You can also change the estimated bolus if desired 1 The bolus calculator feature and the Combo Extended Bolus function must be turned on and the settings must be programmed See Bolus Calculator for more information 2 Enter a bolus calculator process After you enter your BG and or carbs the calcu...

Страница 140: ...mbo Bolus will not be available until the active Extended Bolus finished Note If there is a correction part in the suggested bolus dose the correction part can only be delivered as a Normal Bolus or the normal part of a Combo Bolus In other words the Extended Bolus option will become unavailable in that case Extended Bolus To set an Extended Bolus follow these steps a The extended duration screen ...

Страница 141: ...G Reminder turned on You can accept or modify the time before you are reminded to check your blood glucose after a bolus See BG Reminder in this chapter for more information Combo Bolus To set a Combo Bolus follow these steps a Tap the blue icon to increase Normal Bolus Tap the purple icon to increase Extended part b Enter the amount of time you want the Extended Bolus to last and tap Next to cont...

Страница 142: ...eminded to check your blood glucose after a bolus See BG Reminder in this chapter for more information c Details of the Combo Bolus will be displayed Slide to deliver to start delivery 5 3 Preset Bolus The preset bolus feature enables you to program bolus deliveries for frequent use You can set up to seven preset bolus amounts Breakfast Lunch Dinner Snack Bolus 1 Bolus 2 and Bolus 3 B u r e a u V ...

Страница 143: ...Setup 2 Select a preset bolus you want to edit If it has been edited the current settings will appear 3 Choose a bolus type For a Normal Bolus set the bolus amount For an Extended Bolus set the bolus amount and duration For a Combo Bolus set the bolus amount normal extended percentages and duration B u r e a u V e r i t a s ...

Страница 144: ...he Preset Bolus screen Main Menu Bolus Preset Bolus The existing preset bolus settings are displayed on this screen If you have not set up any preset bolus this screen shows No Presets 2 Select the preset bolus you want to deliver Note The BG Reminder screen will appear if you have BG Reminder turned on See BG Reminder in this chapter for more information B u r e a u V e r i t a s ...

Страница 145: ...ary activities or different conditions For example you might want to increase basal rate on sick days or decrease during exercise You can set the duration of a temp basal rate up to 24 hours in half hour increment Note During a temp basal delivery the basal pattern is temporarily overwritten thus not available After the temp basal delivery is completed or canceled your system will return to the se...

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