Page 1 Simplifying Diabetes TouchCare ® Insulin Management System (color touchscreen) User Guide...
Page 3 Humalog® is a trademark of Eli Lilly and Company. NovoLog® is a trademark of Novo Nordisk A/S. Apidra® is a trademark of Sanofi S.A. 0197 Medtrum Technologies Inc. This product complies with 7F, Building 8, No. 200, Niudun Directive 93/42/EEC (MDD) and Road Directive 2014/53/EU (RED).
Page 4: Table Of Contents
1.4.7 FCC Caution ................... 8 1.4.8 IC Caution ..................9 1.5 Warranty Information ..............10 2 Your A6 TouchCare® System (color touchscreen) ....... 15 2.1 Personal Diabetes Manager (PDM) ..........15 2.2 Patch Pump ................16 2.3 Glucose Sensing System (Optional) ..........16 3 How to Use the PDM ..............
Page 5 3.2 Setting up the PDM ..............23 3.2.1 Select language and country/region ........... 23 3.2.2 Time and Date ................24 3.2.3 Bolus Calculator ................25 3.3 Status Bar Icons ................26 3.3.1 Battery Icon ................. 26 3.3.2 Time Icon ..................27 3.3.3 Audio Icon ...................
Page 6 3.10 Bolus ..................44 3.10.1 Normal Bolus ................44 3.10.2 Max Bolus .................. 49 3.11 Basal ..................50 3.11.1 Your Basal Settings ..............50 3.11.2 Edit Your Standard Basal Pattern ..........51 3.11.3 Check the Current Basal Rate ............ 54 3.11.4 Review Your Basal Patterns............
Page 7 4.1.3 Enter Pump Base SN ..............82 4.2 Activate a New Reservoir Patch ........... 86 4.3 Connect the Pump Base to a New Reservoir Patch ......87 4.4 Fill the New Reservoir Patch ............88 4.5 Prime the Pump ................91 4.6 Select and Prepare the Infusion Site ..........
Page 8 6.4 Insert a New Sensor ..............131 6.4.1 Select an Insertion Site .............. 131 6.4.2 Prepare the Insertion Site ............132 6.4.3 Unpack the Glucose Sensor............132 6.4.4 Remove the Protective Liner from the Sensor Support Mount 133 6.4.5 Locate the Sensor Support Mount ..........133 6.4.6 Remove the Safety Lock ............
Page 9 8.1 Glucose Alerts ................159 8.1.1 High/Low Limits ................. 160 8.1.2 Predictive Alerts ................ 162 8.1.3 Rate Alerts ................. 163 8.1.4 Repeat ..................167 8.2 Low Suspend ................168 8.2.1 Low Suspend ................168 8.2.2 Predictive Low Suspend ............171 9 Settings ..................
Page 10 Your PDM will not beep or vibrate for all the other PDM alerts..219 10.5 Reminders ................220 11 Troubleshooting ..............223 11.1 Troubleshooting A6 TouchCare System issues (in general) ..223 11.2 Troubleshooting PDM issues ............225 11.3 Troubleshooting Pump issues ...........225 11.4 Troubleshooting CGM issues ............226...
Page 11 14.3 Transmitter Specifications ............235 14.4 Glucose Sensor Specifications ..........236 14.5 CGM System Accuracy ............. 236 15 Glossary ................239 viii...
Page 12: Introduction
TouchCare® System is approved. To order supplies, contact your local representatives. 1.2 Indications The A6 TouchCare® System is indicated for use in people (ages 2 and older) with diabetes. The system is intended for single patient use and should be used under the guidance of a healthcare provider.
Page 13: Contraindications
Medtrum distributor. The A6 TouchCare® System has many different settings and features. It is best to talk with your healthcare provider to determine which settings and features are right for you. Some features require great knowledge of insulin pumping and...
Page 14 General Warnings No modification of this system is allowed. Do NOT use the A6 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.
Page 15 Patch Pump Warnings In case the A6 TouchCare® System is unable to properly deliver insulin you must be prepared to give yourself an injection of insulin. Knowing how to do this will help to avoid the risk of diabetic ketoacidosis (DKA) or very high blood glucose (BG).
Page 16 Operating Temperature Range Your A6 TouchCare® System is designed to operate between 5°C (41°F) and 40°C (104°F). Do NOT expose the system to temperatures outside that range. Do NOT expose the system to direct sunlight for a long period of time.
Page 17: Consumables
• Move or relocate the A6 TouchCare® System. • Increase the distance between the A6 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 A6 TouchCare®...
Page 18: Emergency Kit
 Urine ketone testing supplies  Insulin syringe  Rapid-acting U-100 insulin  Extra Medtrum 2.0 mL Reservoir Patches  Power Bank  Instructions from your healthcare provider about how much insulin to inject if pump delivery is interrupted ...
Page 19: Storage
Warning: The Patch Pump may not be able to deliver normally in water. The Transmitter may not be able to send data normally in water. Note: Hot water may decrease Sensor life. 1.4.6 Storage Store the Pump Base and Reservoir Patch at temperatures between -10°C (14°F) and 55°C (131°F), and at humidity levels between 20% and 90% relative humidity.
Page 20: Ic Caution
Information to user. Any Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.
Page 21: Warranty Information
PDM is repaired or replaced, the warranty period shall not be extended. The warranty is valid only if the PDM is used in accordance with Medtrum’s instructions and will not apply: •...
Page 22 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 recertified Pump Base, at Medtrum’s discretion) any defective Pump Base, subject to the conditions and exclusions stated herein.
Page 23 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.
Page 24 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.
Page 26: Your A6 Touchcare® System (Color Touchscreen)
2 Your A6 TouchCare® System (color touchscreen) 2.1 Personal Diabetes Manager (PDM) The Personal Diabetes Manager (PDM) monitors and controls your Patch Pump and Continuous Glucose Monitoring System via wireless RF communication. It stores your Pump and Sensor data of the last 90 days. Keep the PDM with you at all times so that, when needed, you are able to deliver a bolus, change the basal rate, check your glucose level and so on.
Page 27: Patch Pump
(MD-JN-012) 2.3 Glucose Sensing System (Optional) The Glucose Sensing System is an optional part of the A6 TouchCare® 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.
Page 28 ✓ ✓ Glucose Sensor Transmitter (MD-JY-006 or JY-016) (MD-TY-012) (Consumable) ✓ ✓ USB charging cable Transmitter dock...
Page 30: How To Use The Pdm
3 How to Use the PDM 3.1 Basics of the PDM We recommend that your PDM is only used by an intended and qualified operator. 3.1.1 Turn on/off the PDM 1) Turn-on When you long-press the power button, a green light will flash, the ⚫...
Page 31: Charge The Pdm
Or you long-press the power button for about 6 seconds, a yellow light ⚫ will go on for about 2 seconds, indicating that the shutdown is completed. 3.1.2 Charge the PDM As a safety measure, the PDM will give you “PDM BATTERY LOW” or “CHARGE PDM NOW”...
Page 32: Power Mode
3.1.3 Power Mode The PDM has two power modes: 1. Sleep Mode The PDM enters the Sleep Mode after screen backlight timeout and the screen shuts down. You can turn the PDM into Lock Screen of Awake Mode by short-pressing the Power button. a.
Page 33: Scroll Bar
An Alarm occurs when the screen is locked. An Alarm occurs when the screen is not locked. 3.1.4 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.
Page 34: Setting Up The Pdm
3.2 Setting up the PDM 3.2.1 Select language and country/region 1. Select your language, then tap Next. You can change language. See “Language” in Chapter “Settings” for setup instructions. 2. Select your country/region, then tap Next.
Page 35: Time And Date
3.2.2 Time and Date When starting 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.
Page 36: Bolus Calculator
Tap the blue button to increase and to decrease minute on the 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.
Page 37: Status Bar Icons
If you choose Setup, the Bolus Calculator function will be forced to turn on; If you choose Skip, the Bolus Calculation function will stay turned-off. 3.3 Status Bar Icons 3.3.1 Battery Icon The battery icon shows the remaining battery life. ➢...
Page 38: Time Icon
Less than 10% charged At least 10% charged At least 20% charged At least 60% charged At least 80% charged Fully charged 3.3.2 Time Icon You can select the current time displayed in a 12-hour or 24-hour format. The AM or PM appears in the 12-hour format. For instructions on setting the time on your PDM.
Page 39: Pump Rf Signal Icon
Alert Silence + Audio off /Vibrate off 3.3.4 Pump RF Signal Icon A Pump RF 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 3.3.5 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...
Page 40: Pump Status
1. Alert/Alarm 2. PDM Battery 3. EasyLoop Icon 4. Insulin Pump Delivering Status 5. IOB (Insulin On Board) 6. Time 7. Pump RF Signal 8. Audio and Vibration 9. Calibration 10. Sensor Status Note: At this screen, slide on the screen from right to left, you can open main menu screen.
Page 41 Green ring with dark green part Green and dark represents Temp Basal, the dark green green ring part indicates the progress of Temp Basal delivery. Blue ring represents the Normal Bolus, Blue and dark the dark blue part indicates the blue ring progress of delivery.
Page 42: Sensor Status
3.4.2 Sensor Status You can view the Sensor Status on the Home Screen. 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.
Page 43 If your Sensor is on a 24-hour calibration routine, the calibration icon grows fuller as the time for the next calibration. The next calibration is due in 20 to 24 hours. The next calibration is due in 16 to 20 hours. The next calibration is due in 12 to 16 hours.
Page 44 A calibration is needed now. ➢ Data recovery status icon If you disconnect the Sensor for a while and reconnect it, it takes some time to recover the data. The icon indicates that data is being recovered. It disappears when data-recovery is completed. ➢...
Page 45: Easyloop Icon
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 glucose is above 22.2 mmol/L (400mg/dL). LOW - Sensor glucose is below 2.2 mmol/L (40mg/dL).
Page 46: Sensor Graph
It will appear when Low Suspend or Predict Low function is available for now or when Low Suspend or Predict Low is triggered and the insulin delivery has been suspended. It will appear when Low Suspend or Predict Low function is unavailable for now.
Page 47: Alarm Status
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 ⚫...
Page 48: Lock Screen
3.5 Lock Screen The PDM displays the Lock Screen every time you turn it on to view glucose Information, insulin delivery information, alarm/alert information, date and time. You also can customize this screen by editing your username. See “Username” in Chapter “Settings” for more information. The PDM displays the Lock Screen after display timeout.
Page 49: Notification Screen
See Chapter “Safety System and Alarms” for more information about Alarm, Alert or Reminder status. 3.6 Notification Screen Notification Screen only records alert and alarm notifications which are still effective today. You can slide from top to bottom on Home Screen to call the Notification Screen.
Page 50: Shortcut Screen
3.7 Shortcut Screen Shortcut Screen grants you quick access to a few settings including Bolus, Calibration, Audio, Vibration and Brightness. You can slide from bottom to top from Home Screen to call the Shortcut Screen. 1) Calibration Shortcut icon “ ”...
Page 51: Status Screen
3.8 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 right to left or tap Home key on the Status Screen to go back to the Home Screen. The Status Screen displays the following information.
Page 52: Menus
Other Info Device Info 3.9 Menus The Main menu consists of nine sub-menus: Bolus, Basal, Suspend, Patch, Sensor, History, Event, EasyLoop, Settings. Slide from right to left on the Home Screen to open Main Menu. Note: After all insulin delivery is suspended, the Suspend icon on the Main Menu turns into Resume icon.
Page 53: Bolus
3.9.1 Bolus The Bolus menu contains the settings and functions for bolus deliveries. See “Bolus” in this chapter for more bolus information, and Chapter “Advanced Pump Features” for advanced bolus settings. 3.9.2 Basal On Basal menu you can deliver temp basal insulin, select and view different basal pattern.
Page 54: Patch
3.9.4 Patch You can change your Reservoir Patch and check Pump Base SN on Patch menu. See Chapter “How to Change the Reservoir Patch” for more information. 3.9.5 Sensor The Sensor menu contains calibration and connection functions of the Glucose Sensor.
Page 55: Bolus
Consult your healthcare provider about how to set your bolus dose. Your A6 TouchCare® 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.
Page 56 Set your bolus amount. Select Normal Bolus type. Bolus type is Normal Bolus, Extended Bolus or Combo Bolus. Tap Next to confirm if the bolus setting is correct.
Page 57 Note: You can set a bolus dose between 0 and the Max Bolus. When an extend Bolus is already being delivered, you can only choose a Normal Bolus. Note: The BG Reminder screen will appear if you have BG Reminder turned on. See Section “BG Reminder”...
Page 58 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 Home Screen. You can cancel an active Normal Bolus in the Suspend Menu even after insulin delivery has started.
Page 59 If the delivery value given exceeds the remaining insulin amount in the Reservoir, the screen will show the following reminder: If the total Bolus in the last 30 minutes has already exceeded 10 U, the screen will show the following reminder:...
Page 60: Max Bolus
If connection between PDM and Pump failed during delivery, the screen shows “Checking Pump status”, the delivery cannot be cancelled. When insulin delivery is completed, PDM display returns to the Home Screen automatically. 10. When a Normal Bolus is being delivered, if the PDM screen goes dark as a result of display timeout, you can slightly shake the PDM to light up the screen again.
Page 61: Basal
You can program up to 5 basal patterns with the A6 TouchCare® System. Having more than one pre-set basal pattern makes it easy for you to switch between patterns to cater to your different...
Page 62: Edit Your Standard Basal Pattern
 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.  Pattern A/B: Basal patterns for you to define, such as menstruation, etc. We recommend that you set your basal rates with the assistance of your healthcare provider.
Page 63 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 pattern cannot be edited.
Page 64 Note: ➢ The first basal segment always starts at 00:00 (12:00 am). ➢ The last basal segment always ends at 23:59 (11:59 pm). ➢ Segments can start since each hour or each half-hour. The end time point of the last time segment is always set to be midnight. ➢...
Page 65: Check The Current Basal Rate
Note: You can set a basal rate between 0 and the Max Basal Rate with an increment of 0.05 U/H. When finished, tap to save the basal setup and return to the previous menu. 24 Hour Total Note: If all 48 basal segments were added, the +Add Time Segment button disappears automatically.
Page 66: Review Your Basal Patterns
2. Status➔Basal 3.11.4 Review Your Basal Patterns The Basal Review screen shows your daily basal rates of all patterns. Go to the Basal Review screen. Main Menu➔Settings➔Insulin Pump➔Basal Setup➔Basal Review...
Page 67: Delete A Time Segment Of Basal Pattern
Choose the basal pattern that you want to review. Tap it to review your programmed settings. 3.11.5 Delete a time segment of Basal Pattern 1. Select segment, slide to left on each and a delete button will appear. Tap Delete to delete the selected segment. Slide back to right to close Delete. The last segment cannot be deleted and the starting time of all segments cannot be changed.
Page 68: Change The Time Of The Basal Pattern
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.
Page 69 When the ending time point A of a segment is changed to a later time point B (for example: 12:00 is changed to 15:00), all previous segments between time point A and time point B will be deleted, leaving only the edited segment featuring a period between its original starting time point and ending time point The ending time Point B equals to the starting time point of the segment that follows.
Page 70: Maximum Basal Rate
3.11.7 Maximum Basal Rate 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 basal rate that is set, including a temporary basal. Once your basal rates have been set, you cannot set a maximum basal rate that is less than any of the programmed basal rates.
Page 71: Suspend And Resume
3.12 Suspend and Resume 3.12.1 Suspend Insulin Delivery Sometimes you may need to suspend insulin delivery. When no bolus is being delivered, you can suspend basal insulin delivery for a set period of time. When the Bolus is being delivered, you can choose to suspend all insulin deliveries (basal and bolus) for a set period of time or to just stop the bolus currently being delivered.
Page 72 Note: You can set the suspension time between 15 min and 2 hours with an increment of 15 min. The following message will appear. Slide to Suspend if you want to suspend insulin delivery. Note: When you suspend insulin delivery, Bolus and Temp Basal will be canceled and cannot be resumed.
Page 73 The remaining suspend time can be found on Home Screen. b. When a Normal/Extended/Combo Bolus is being delivered. 1. You can choose to suspend all insulin delivery or only the bolus. Main Menu➔Suspend...
Page 74: Resume Insulin Delivery
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.
Page 75: Events
Only basal pattern can be resumed, Bolus and Temp Basal cannot be resumed. 3.13 Events The A6 TouchCare® System is able to record different events including blood glucose, carbs, insulin injection, health condition, exercise and others. This information can help you and your healthcare provider make better decisions about your diabetes management plan.
Page 76: Bg Measurement
3.13.1 BG Measurement 1. Select BG Type in the Event 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.
Page 77: Insulin Injection
3.13.2 Insulin Injection Select Injection in the Event screen. Choose the date and time for insulin injection. Tap Type option, you can choose the insulin type between “Rapid-acting”, “Short-acting”, “Mediate-acting”, “Long-acting”, “Pre-mixed” and “unselected”. Tap Dose value to select the amount of insulin you use. The input range is 0.1-99 units.
Page 78: Physical Exercise Information
4. When finished, tap Save to confirm or press to cancel. 3.13.4 Physical Exercise Information 1. Select Exercise in the Event 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”.
Page 79: Health Information
3.13.5 Health Information Select Health in the Event screen. Choose the date and time for health information Tap Health option to select the physical condition. You can choose the intensity between “Illness”, “Stress”, “High Symptoms”, “Low Symptoms”, “Menstruation” and “Alcohol”. When finished, tap Save to confirm input.
Page 80: History
For example, when you want to enter “a”, tap abc and select “a”. Tap ABC to switch to captial. Tap and choose the letters for text input. Note: Use no more than 22 characters to describe an event. When finished, tap Save to confirm input. Or press to cancel.
Page 81: Pump History
Main Menu➔History 3.14.1 Pump History The Pump History displays the delivery history (bolus, basal and total daily delivery history) and alert history (pump alerts and alarms). Go to the Pump History screen. Main Menu➔History➔Pump History Delivery History You can select one day to review its delivery graph. It displays the summary of basal, bolus and total delivery for one day.
Page 82 1. Tap the date to switch between records of different dates 2. Tap the info icon to review legend meanings. 3. Tap the “Basal, Bolus, Total“ summary chart at the bottom of Delivery History screen to see details. (1) The legend Significance Legend Abbreviation...
Page 83 EXCEEDS MAX TDD, EXCEEDS MAX 1HR DELIVERY ALARM. Manually suspend all insulin Manual Suspend delivery Including deactivate patch, discard patch, and alarms: OCCLUSION DETECTED, PATCH EXPIRED, PATCH ERROR, Stop PATCH BATT DEPLETED, PUMP BASE ERROR, EMPTY RESERVOIR. When you activate a new New Patch patch, this icon appears.
Page 84 Bolus Type:  N: Normal Bolus  E: Extended Bolus  C: Combo Bolus  Normal: Normal Bolus by Manual Bolus  Extended: Extended Bolus by Manual Bolus  Combo: Combo Bolus by Manual Bolus  Calc-N: Normal Bolus by Bolus Calculator ...
Page 85  N represents Normal Bolus.  E represents Extended Bolus.  C represents Combo Bolus.  FoodBolus 7.30U #1 means that there is one food bolus doses in the selected day with a total amount of 7.30U.  CorrBolus 2.10U #1 means that there is one correction bolus doses in the selected day with a total amount of 2.10U.
Page 86: Pdm Alert History
Tap the date to switch between records of different dates. Tap each Alert/Alarm to view alert detail information. Tap to return to the previous menu. See Chapter “Alert Icons” for more information about how to address alarms and alerts and the meanings of different alarm/alert icons. 3.14.2 PDM Alert History PDM History stores PDM Alert history.
Page 87: Event History
See Chapter Alert Icons for more information about how to address alarms and alerts and the meanings of different alarm/alert icons. 3.14.3 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.
Page 88 BG History contains BG from Calibration , Event BG and Lab value BG input during Bolus delivery through Bolus Calculator Tap the date or “ ” , “ ”to switch between records of different dates.
Page 90: How To Change The Reservoir Patch
4 How to Change the Reservoir Patch The Reservoir Patch requires replacement and shall not be reused. The Reservoir Patch should be replaced approximately every 2-3 days or as directed by your healthcare provider. Warning: Do NOT attempt to apply or use a Patch Pump before you have been trained by your healthcare provider.
Page 91: Deactivate The Current Reservoir Patch
Note: The syringe provided by Medtrum matches the fill port on the Reservoir Patch. Other syringes and needles meeting the following specifications are also permitted. Specifications of syringe:  Reservoir volume: 2.0 mL  Needle size: 26G  Needle length: 8 mm (0.31’’) ...
Page 92: Remove The Current Reservoir Patch
Several seconds later, you will see a message showing that the Patch has been deactivated. 4.1.2 Remove the Current Reservoir Patch 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.
Page 93: Enter Pump Base Sn
Note: To avoid possible skin irritation, remove the Reservoir Patch slowly and gently. If any adhesive remains on your skin, remove it with soap and water. Warning: Check the infusion site for signs of infection. Press and hold the two release buttons on both ends of the Pump Base and pull the Pump Base off the old Reservoir Patch.
Page 94 You can find Pump Base SN on the product box or on your Pump Base. 1. You can either enter SN manually or search for the SN 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...
Page 95 Tap --------- or the existing Pump base SN, you will see the following screen. Then enter the SN to your PDM and tap Done. Note: If it is an 8-digit SN, enter space ” ” at the end. Search for the SN You can select Search to search for the SN if it is the first time you enter the SN.
Page 96 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. If your PDM finds multiple Pumps, the SNs won’t be displayed to prevent you from selecting the wrong SN.
Page 97: Activate A New Reservoir Patch
If your PDM does not find a Pump, make sure that 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. 4.2 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.
Page 98: Connect The Pump Base To A New Reservoir Patch
4.3 Connect the Pump Base to a New Reservoir Patch Tap Next on your PDM and you will see the following message on the screen. Warning: Do NOT use a Reservoir Patch if its 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.
Page 99: Fill The New Reservoir Patch
Warning: If the Pump fails to beep or the indicator light fails to flash, call customer support. It may put your health at risk if you continue to use the Pump. Warning: If a single fault condition occurs, the indicator light flashes red, and the Pump cannot proceed to the next step, call customer service.
Page 100 While still holding the plunger rod, flip the vial over so the vial is on top, and then slowly pull down on the plunger to fill the syringe with the number of desired units. Gently tap the side of the syringe to make air bubbles rise to the top of the syringe.
Page 101 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 the plunger.
Page 102: Prime The Pump
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.
Page 103 After that, tap Next on your PDM to prime the Pump. Warning: Do NOT remove the button cover before priming is completed. Once completed, the next screen “Attach and Insert” appears, and the Pump vibrates three times.
Page 104: Select And Prepare The Infusion Site
Warning: If the Pump fails to vibrate, call customer support. To continue using the Pump may put your health at risk. 4.6 Select and Prepare the Infusion Site The place on your body where you attach the Pump is important for the success of your therapy.
Page 105: Attach The Patch Pump
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.
Page 106 Peel off the adhesive liner from the bottom of the Reservoir Patch. Remove the liner and expose the adhesive. Avoid touching the stickiness of the adhesive pad, press the Pump against the skin at the selected infusion site. 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.
Page 107: Start Insulin Delivery
Note: The adhesive of the Reservoir Patch keeps the Patch position secured for up to 3 days. Several products are available to enhance adhesion if necessary. Ask your healthcare provider about these products. Avoid getting body lotion, creams, or oil near the infusion site because it may loosen the adhesive. Note: The adhesive is designed for one-time use.
Page 108 Slide to activate basal delivery if the needle is properly inserted. Or tap Home Key if you find a problem with 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.
Page 112: Advanced Pump Features
5 Advanced Pump Features 5.1 Bolus Calculator With your input of the number of carbs eaten and your current (actual) BG value, this feature can automatically calculate your Food Bolus and Correction Bolus, based on your Insulin-to-Carbohydrate ratio (I:C ratio), Insulin Sensitivity Factor (ISF), BG Target and the amount of IOB for the current time.
Page 113 Turn on or off Bolus Calculator. The factory default is off. Note: IC Ratios is the abbreviation for Insulin-to-Carb Ratios. BG is the abbreviation for blood glucose. Insulin to Carb (I:C) Ratios An Insulin to Carb (I:C) ratio features the amount of carbs you can cover with one unit of insulin.
Page 114 1. The first segment always starts at midnight. The Carbs field is indicated by the blue editable digit. You can tap the blue digit to change it. Note: You can set the carbs between 1.0 g and 200 g. When the carbs is between 1.0 g and 9.9 g, the increment is 0.1 g.
Page 115 4. When finished, press to save settings. Or Press to cancel setup and exit the edit mode. Insulin Sensitivity An insulin sensitivity factor (ISF) evaluates the blood glucose level you can expect to lower with one unit of insulin. This value is used to calculate a suggested insulin dose to correct a high BG.
Page 116 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 ISF segments as recommended by your healthcare provider. Note: Select segment, slide to left on each and a delete button will appear.
Page 117 BG Target A BG Target is your personal goal for keeping your BG levels under control. A BG Target may be set as an actual range (with a low limit and high limit), or a single value. Because your targets may vary throughout the day, you can set up to eight BG targets.
Page 118 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.
Page 119: Normal Bolus Using Bolus Calculator
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 can calculate an estimate of insulin you need for your correction bolus or food bolus.
Page 120 Note: (1) If you are not entering a BG and want a bolus for food, enter only your carbohydrate amount, the bolus calculator feature will calculate an 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).
Page 121 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.
Page 122: Combo/Extended Bolus
Note: You can cancel an active Normal Bolus (one 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.
Page 123: Combo/Extended Bolus Without Bolus Calculator
Note: It is important that you consult with your healthcare provider before using a Combo/Extended Bolus. You should be familiar with the basic functions of your PDM before exploring these options. 5.2.1 Combo/Extended Bolus Without Bolus Calculator Calculate your food and/or correction bolus amount. In the Bolus Menu screen, select Manual Bolus.
Page 124 Note: You can set the duration between 30 min and 8 h with an increment of 30 min. Details of the Extended Bolus 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.
Page 125 Note: You can set a bolus dose between 0 and the Max Bolus. Note: The number of units you enter for the Combo Bolus is a total amount of Normal Bolus and Extended Bolus units. Tap Type option to choose Combo Bolus. Then tap Next. Tap the blue icon to increase Normal Bolus.
Page 126: Combo/Extended Bolus Using Bolus Calculator
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 Chapter “Settings” for more information.
Page 127 Note: If you need to make any changes in the previous menu, press return to the previous menu, select Bolus Calculator, and re-enter the values. You can adjust the Set Bolus as needed. Note: You can set a bolus dose between 0 and the Max Bolus. Note: If there is an active Extended Bolus, the extended or Combo Bolus will not be available until the active Extended Bolus finished.
Page 128 To set an Extended Bolus, follow these steps: The extended duration screen appears. Enter the amount of time you want the Extended Bolus to last and tap Next. Note: You can set the duration between 30 min and 8 h with an increment of 30 min.
Page 129 To set a Combo Bolus, follow these steps: Tap the blue icon to increase Normal Bolus. Tap the purple icon to increase Extended part. 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 8 h with an increment of 30 min.
Page 130: Preset Bolus
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. 5.3.1 Preset Bolus Setup Go to the Preset Bolus Setup screen.
Page 131: Deliver A Preset Bolus
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. Tap Save to save the settings. Tap or Home button and tap No to quit the settings.
Page 132: Select A Basal Pattern
The existing preset bolus settings are displayed on this screen. If you have not set up any preset bolus, this screen shows No Presets. 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”...
Page 133: Activate A Temp Basal
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 selected basal pattern. 5.5.1 Activate a Temp Basal Go to the Temp Basal screen. Main Menu➔Basal➔Temp Basal Select a temp basal type, temp rate or percent and duration, then Tap Next to review the temporary basal rates set.
Page 134: Cancel A Temp Basal
5.5.2 Cancel a Temp Basal Go to the Cancel Temp Basal screen. Select Cancel Temp Basal. Main Menu➔Basal➔Cancel Temp Basal Slide to stop temp basal delivery, or tap to continue delivering. Note: If you suspend insulin delivery while a temp basal rate is active, the temp basal rate will be canceled.
Page 135: Preset Temp Basal
5.6 Preset Temp Basal With the preset temp basal feature, you can program temp basal rates for recurring short-term situations. You can set up to six preset temp basal rates: Heavy Ex, Medium Ex, Light Ex, Sick, Temp 1, and Temp 2. 5.6.1 Preset Temp Basal Setup Go to the Preset Temp Setup screen.
Page 136: Activate A Preset Temp Basal
Set the duration and rate/percentage of the preset temp basal. Tap Save to save settings. 5.6.2 Activate a Preset Temp Basal You must set up a preset temp basal before you can activate it. Go to the Preset Temp Basal screen. Main Menu➔Basal➔Preset Temp Basal The programmed preset temp basal types are displayed on this screen.
Page 140: How To Change The Sensor (Optional)
6 How to Change the Sensor (Optional) Your Sensor gives glucose readings for up to seven or fourteen days. When a Sensor expires or fails, your Sensor session ends automatically, and PDM displays no more glucose readings. You must remove the Sensor and disconnect the Transmitter.
Page 141: Charge The Transmitter
Pinch the ribbed release tabs on the sides of the Sensor support mount, and gently pull the Transmitter away from the Sensor support mount. Discard the Sensor support mount and reuse the Transmitter. Note: Do Not discard your Transmitter. It is reusable and rechargeable. Note: Make sure that you completely disconnect the Transmitter from the Sensor when you do.
Page 142: Insert A New Sensor
The indicator light will flash when the Transmitter is being charged, and go off when the Transmitter is fully charged. Note: We recommend that your Transmitter is only charged by an intended and qualified operator. 6.4 Insert a New Sensor 6.4.1 Select an Insertion Site When choosing the location for the Sensor, consider the following: ...
Page 143: Prepare The Insertion Site
Front Back Front Back If you choose an insertion site on your abdomen (buttock for children), apply the Sensor horizontally. If you choose an insertion site on your upper arm, apply the Sensor vertically. Have a rotation schedule for choosing a new site. Using the same site too often might not allow the skin to heal and can possibly cause scarring or skin irritation.
Page 144: Remove The Protective Liner From The Sensor Support Mount
Warning: Do NOT use a Sensor if its sterile package has been damaged or opened, or the Sensor has expired, or the Sensor is damaged in any way. Note: Wash your hands with soap and water and let them dry before opening the Sensor package and handling the Sensor.
Page 145: Remove The Safety Lock
6.4.6 Remove the Safety Lock Hold the Glucose Sensor with one hand. Firmly squeeze the two release tabs of the safety lock with your thumb and index finger of the other hand, as you lift the safety lock away from the inserter. Keep the safety lock, you will need it later.
Page 146: Remove The Inserter
6.4.8 Remove the Inserter Pinch and hold the ribbed release tabs on the sides of the Sensor support mount with one hand, twist the inserter about 40° in the direction (anticlockwise) shown with the other hand, until the orange triangle marked on the inserter lines up with the orange line on the Sensor support mount, and then lift the inserter vertically away from the mount.
Page 147: Attach Your Transmitter
inserter. We recommend discarding the Sensor inserter into a sharps container or a puncture-proof container with a tight lid. 6.5 Attach Your Transmitter Note: If you are changing Sensor, make sure that your Transmitter was disconnected from the old Sensor at least one minute before being connected to the new Sensor.
Page 148: Set The Transmitter Sn
The Sensor support mount should stay on your skin using its own adhesive. But, if you find that the Sensor support mount is not adhering well during daily activities, you can use medical tape for extra support. Only tape over the white adhesive pad on all sides for even support.
Page 149 You can find the Transmitter SN on the product box or on the back of the Transmitter. 2. You can either enter SN manually or search for the SN if it is the first time you enter the SN. 3. You can only enter SN manually if you want to update the SN.
Page 150 Enter SN manually Tap --------- or the existing Transmitter SN, you will see the following screen. Then enter the SN to your PDM and press Done. Search for the SN If you select Search, make sure that your Transmitter is connected to a new Sensor and move the PDM closer to your CGM before searching.
Page 151 If your PDM finds one Transmitter, the Transmitter SN appears on the screen. Confirm it once it matches the SN printed on your Transmitter. If it is correct, tap OK. If your PDM finds multiple Transmitters, tap OK to go back to Sensor Menu, then select “---------”...
Page 152: Connect Sensor To Your Pdm
If your PDM does not find a Transmitter, make sure that your Transmitter is connected to a new Sensor, move the PDM closer to your CGM, and enter the SN manually. 6.7 Connect Sensor to Your PDM Go to Connect Sensor screen. Main Menu➔Sensor➔Connect Sensor Note: The Connect Sensor option is only available when no Sensor is currently...
Page 153 Make sure that your Transmitter is connected to a Sensor and that your Transmitter SN is found or entered, and then continue to connect the Sensor to your PDM. When finished, the following screen appears. Note: If you want to remove a Sensor before its expiration, disconnect it from your PDM first before you connect a new Sensor.
Page 156: Cgm Features (Optional)
7 CGM Features (Optional) 7.1 CGM Feature on/off 7.1.1 Turn on/off the CGM Feature The CGM feature must be turned on to receive Sensor data. Select CGM System in the Settings menu. Main Menu➔Settings➔CGM System You can turn on or off the CGM feature. After you turn on the CGM System, the Transmitter SN menu appears.
Page 157: Add Transmitter Sn
7.1.2 Add Transmitter SN Tap Settings on the Main Menu to enter the Settings screen. Tap CGM System to enter the CGM settings screen. Turn the CGM System feature on. Tap Transmitter SN to add this Transmitter to your PDM. You can use your PDM to search for your Transmitter (only for the first time), or you can enter the SN printed on your Transmitter manually.
Page 158: Enter Your Meter Bg
Note: Calibration should be done at least once every 12 or 24 hours according to your Sensor model, otherwise the glucose reading could be inaccurate and you might miss a low or high blood glucose value. Note: MD-JY-006 Glucose Sensor should be calibrated every 12 hours. JY-016 Glucose Sensor should be calibrated twice (once every 12 hours) on the first day and then only once every 24 hours since the second day.
Page 159 Note: Please enter the exact blood glucose value of a carefully performed fingerstick displayed on your blood glucose meter within five minutes. Tap Done to confirm your fingerstick, then tap Yes button to start calibration. When finished, the following screen appears.
Page 160: Set Calibration Repeat
7.2.2 Set Calibration Repeat Go to the Cal Repeat screen. Main Menu➔Settings➔CGM System ➔ Cal Repeat After you receive and clear a “METER BG NOW” alert, PDM will repeat the alert until you enter a new blood glucose measurement. You can set the repeat time of “METER BG NOW” alert from 5 min to 1h with an increment of 5 min.
Page 161: Set Your Sensor
Go to the Cal Reminder screen. Main Menu➔Settings➔Reminders ➔Cal Reminder You can turn Cal Reminder on/off. Note: If Cal Reminder is on, you can set the time between 5 min and 6 h with an increment of 5 min. 7.3 Set Your Sensor Go to the CGM System screen.
Page 162: Alert Silence
7.3.1 Alert Silence Go to the Alert Silence screen. Main Menu➔Settings➔CGM System➔Alert Silence Warning: Muting the alarms is not recommended when you are unable to interact with your PDM (for instance, when you are asleep). Interacting with your PDM includes activities such as pressing the power button and checking the screen.
Page 163: Sensor Expired
 All — The PDM will not beep or vibrate if “LOST SENSOR”, “SENSOR CAL REMINDER”, “METER BG NOW”, “SENSOR EXP IN 6 HOURS”, “SENSOR EXP IN 2 HOURS”, “SENSOR EXP IN 30 MINS”, “SENSOR EXPIRED”, or any of the high/low alert occurs during the specified time. See “Status Bar Icons”...
Page 164: Data History
7.4.1 Data History Select Data History in the Sensor History screen. The Data History screen shows all of the Sensor sessions that have recently occurred. Each line shows the Sensor session start date and duration (day/hour/minute). For example, the record 28-08-2018 5/21/8 means the Sensor was started on 28-08-2018 and has been used for 5 days 21 hours and 8 minutes.
Page 165 Note: Tap the Sensor graph and move the cursor to spot the glucose values. Use ⚫ the left and right arrow button to do fine adjustment for choosing the time. The time interval between two values is 2 minutes. The time a new Sensor is applied will be marked with a green square tag ⚫...
Page 166: Calibration History
Tap the date and you will see a list of dates within that session. Select a date and you will see the 24-hour Sensor trend graph of that day. 7.4.2 Calibration History Select Calibration History in the Sensor History screen. The Calibration History screen displays the calibration history.
Page 167 Select an alert record to view the details. Tap to return to the previous menu. See Chapter “Alert Icons” and Chapter “Safety System and Alarms” for more information about how to address the alarms and alerts.
Page 170: Easyloop Technology (Optional)
8 EasyLoop Technology (Optional) The Glucose Alert and Low Glucose Suspend/Predictive Low Glucose Suspend (Low Suspend/ Pre Low Suspend) functions are included under the EasyLoop Menu. The (Pre) Low Suspend function is available when CGM and Insulin Pump systems are both online. The glucose limits for alerts of Low Suspend and Pre Low Suspend are the same.
Page 171: High/Low Limits
1. You can turn on or off the Glucose Alerts. 2. Tap to save the settings. 8.1.1 High/Low Limits You need to set the high and low Glucose Limits recommended by your healthcare provider after you turn the glucose alerts On. Your recommended glucose limits may vary throughout the day, you can set up to eight pairs for different time periods.
Page 172 1. Add segments The starting time of the first segment is fixed to be 00:00 or 12:00A. Add time segments by choosing from 00:30-23:30 or 12:30A-11:30P, with an increment of 00:30. You will be reminded if the time segment to be set already exists. When the time segments are successfully set, they will be listed chronologically.
Page 173: Predictive Alerts
In the time segments, only the segment starting from 0:00 cannot be ⚫ deleted. You can always edit the input in each segment. The Low Limit rage is 2.8-5.0mmol/L (50-90 mg/dL), the High Limit range is 5.5- 22.2mmol/L (100-400 mg/dL), both with an increment of 0.1mmol/L (1mg/dL).
Page 174: Rate Alerts
2. Tap the blue plus/ minus sign to set the predictive alert time. You will be reminded of a predicted high or low glucose value some time (the predictive alert time) in advance. Note: You can set the time between 5 min and 30 min with an increment of 5 min.
Page 175  Rapid Rise for Sensor glucose increasing at or faster than your pre-selected rate Go to the Rate Alerts screen. Main menu➔EasyLoop➔Glucose Alerts ➔Rate Alerts Go to the Rise screen. 1. You can tap to turn on/off the Rise Alerts. 2.
Page 176 3. You can also set the rate between 0.065 mmol/L/min and 0.275 mmol/L/min (1.1 mg/dL/min and 5.0 mg/dL/min) with an increment of 0.005 mmol/L/min (0.1 mg/dL/min). Tap the blue plus/minus sign to set the rise alert. You will be reminded when your SG is rising rapidly.
Page 177 2. You can choose a relative mild or an acute falling rate. See Chapter “Sensor Status” for more information. You also can set the custom rate between 0.065 mmol/L/min and 0.275 mmol/L/min (1.1 mg/dL/min and 5.0 mg/dL/min) with an increment of 0.005 mmol/L/min (0.1 mg/dL/min).
Page 178: Repeat
3. Tap to save the settings. 8.1.4 Repeat You can set the amount of time between alerts after the first alert. After you receive and clear “HIGH/LOW GLUCOSE”, “RAPID RISE/FALL” or “HIGH/LOW PREDICTED”, the alert will repeat in accordance with your settings until the condition that caused the alert is resolved.
Page 179: Low Suspend
8.2 Low Suspend Go to the Low Suspend screen. Main menu➔EasyLoop➔(Pre) Low Suspend Note: If you turn the Low Suspend on, the Predictive Low Suspend feature will appear. 8.2.1 Low Suspend The Low Glucose Suspend feature is only available when both a Patch Pump and a Glucose Sensor are in use.
Page 180 Time of Suspension Once Low Suspend is triggered, the period of suspension will last for at least 30 minutes unless you manually resume basal insulin. The maximum suspension time is 2 hours. After 2 hours of suspension, basal insulin will be resumed unconditionally.
Page 181 If the Low Suspend alarm is not cleared during suspension and insulin is automatically resumed after 2 hours, the siren will continue and the following emergency message will appear. If the Low Suspend alarm is cleared during suspension, a Reminder will appear when insulin is automatically resumed.
Page 182: Predictive Low Suspend
For information on when the Low Suspend feature is unavailable, refer to “Predictive Low Suspend”. 8.2.2 Predictive Low Suspend The Predictive Low Glucose Suspend feature is available only when the Low Suspend feature is turned on and available. The factory setting for the Predictive Low Suspend feature is turned off.
Page 183 Note: You can set the Time before Low between 5 min and 40 min with an increment of 5 min. The factory default is 30 min. Triggering Conditions for Predictive Low Suspend (from 30 min to 2 h after suspension) Both of the following two conditions must be met to start Predictive Low Suspend.
Page 184 ◼ The Sensor glucose value is predicted to be at least 1.7 mmol/L(30 mg/dL) higher than the low suspend limit in half an hour. Reminder of Resumption Whether a Predictive Low Suspend alert is cleared or not, the same Reminder will appear when insulin is automatically resumed.
Page 185 ◼ The Reminder is not cleared, then the Low Suspend feature and Predictive Low Suspend feature will remain unavailable for 4 hours after resumption.
Page 188: Settings
9 Settings 9.1 CGM System (Optional) Tap CGM System on the Settings screen to enter the CGM System screen. Make sure that the CGM System is turned on. You can set your Sensor in CGM System Screen. You can turn CGM System on or off, set Transmitter SN, set calibration alert repeat time, set alert silence, set Sensor expiration time.
Page 189: Add Pump Base Sn
9.2.1 Add 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.
Page 190: Basal Setup
1. Bolus Calculator See Chapter “Advanced Pump Features” for more information. Consult your healthcare provider before changing this setting. 2. Preset Bolus Setup Chapter 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.
Page 191 1. Edit Basal See Section “Basal” in Chapter “How to use the PDM” for more information. You can set up to 48 basal rates for any basal pattern. 2. Basal Review See Section “Basal” in Chapter “How to use the PDM” for more information. The Basal Review screen shows your daily basal rates of all patterns.
Page 192: Pump Alerts
9.2.4 Pump Alerts 1. Patch Expiration Here you can turn on/off “PATCH EXPIRED” Alarm, “PATCH EXP ADVISORY” Alert, and “PATCH EXP IN 1 HOUR” Alert. When the alerts are turned on, if you do not remove a Reservoir Patch after 72 hours’ use, the “PATCH EXPIRED” Alarm repeats every hour until the system automatically deactivates the current Reservoir Patch after 80 hours’...
Page 193 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 select one of these warning types: ...
Page 194: General Settings
Note: If the Reservoir Patch is changed, the hourly insulin amount will start from 0. Note: Insulin delivery will be automatically resumed at 0:00 am on the next day if suspension occurs after daily max has been exceeded. Note: If you resume insulin delivery manually after the hourly/daily max was exceeded, the previously delivered amount in this hour/day will be cleared and the PDM will record the hourly/daily amount from zero.
Page 195: Language
9.3.1 Language You can change your PDM Language. Main Menu ➔Settings➔General➔Language 9.3.2 Time/Date Setting the correct time and date in your PDM is essential to accurate basal insulin delivery and keeping an accurate record of your insulin delivery and other 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.
Page 196: Audio Options
Date keyboard and Time keyboard 9.3.3 Audio Options Audio/Vibrate You can choose 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.
Page 197: Display Settings
If Audio off /Vibrate off is selected, your PDM and Patch Pump will not beep or vibrate. But there are exceptions: If an alarm is not cleared within 10 minutes, your PDM or/and your Patch Pump will make a siren sound until the alarm is cleared. When “BELOW 3.1mmol/L (BELOW 56mg/dL)”...
Page 198: Confidence Reminder
Slide or tap to adjust the brightness, you can choose between 10 brightness levels. A lower level consumes less power. 9.3.5 Confidence Reminder If this feature is turned on, the PDM will beep and/or vibrate in response to your instructions, including: ⚫...
Page 199 Note: If there is an active Reservoir Patch, Reset Settings and Restore Settings will be disabled. ⚫ Save Take these steps to save your current PDM settings: Select Save in the User Settings screen. If this is the first time saving your PDM settings, this screen appears: If you have saved PDM settings, this screen appears:...
Page 200 Read the instructions on the screen; then tap Next to save your current settings. This screen 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.
Page 201 This screen indicates that your user settings have been restored. Tap OK to exit the menu and check your system settings. ⚫ Reset Warning: Do 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.
Page 202 Tap OK. The PDM will be reset to the factory default settings and restart. ⚫ Settings History On this screen you can review all recent user settings operation records and the date and time. Select Settings History in User Settings screen. Slide to scroll up/down to view the entire settings history.
Page 203: Passcode Lock
9.3.7 Passcode Lock The passcode 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.
Page 204 Enter the 4-digit passcode. Note: The default passcode is 0000. Enter the new passcode twice.
Page 205: Reminders
Turn on Passcode Lock and enter the Passcode to activate Lock, the Passcode Lock is only for one-time use, you need to enter the passcode each time you turn on the function. With the Passcode Lock feature turned on, only the Lock Screen is displayed. You have to enter the correct passcode after you slide to unlock the PDM.
Page 206: Personal Reminders
9.4.1 Personal Reminders 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 Personal Reminder option is turned on.
Page 207: Bolus Reminder
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. 9.4.2 Bolus Reminder When you fail to deliver a Bolus at between time point A and time point B, you will receive a Reminder at time point B.
Page 208 1. Time Point A 2. Time Point B You can add, delete, or review Reminders when the Bolus Reminder option is turned on. Go to the Bolus Reminder screen. Main Menu➔Settings➔Reminders➔ Bolus Reminder Add Reminder Tap + Add Time Segment to add one Reminder, setting the start and end time.
Page 209: Bg Reminder
Note: (1) The end time should be at least 30 min later than the start time. You can program up to four bolus Reminders. (2) The Reminders will be saved automatically. Delete Reminder Slide from right to left on one segment, tap Delete to delete this segment. 9.4.3 BG Reminder After you deliver a bolus, you may want to check your BG.
Page 210 Main Menu ➔Settings➔Reminders➔BG Reminder If you have BG Reminder turned on, the BG REMINDER DURATION screen appears when you set Bolus. It allows you to set the time before you are reminded to check your blood glucose after a bolus. The time ranges from 00:30 to 05:00 with an increment of 30 minutes.
Page 211: Cal Reminder
9.4.4 Cal Reminder You need to calibrate the Sensor every 12 hours or every 12 hours on the first day and every 24 hours during the days after. Calibration Reminder enables you to get reminded a certain time before the due time of next calibration. Main Menu ➔Settings➔Reminders➔Cal Reminder Note: You can set the time between 5 min and 6h with an increment of 5 min.
Page 212 (1) Use the keyboard to enter the username. For example, when you want to enter “a”, tap abc key, “a”,”b”,”c” appear on the top of the keyboard , then select “a”. (2) When finish, tap Done. (3) Tap the name in blue to edit Username again. Note: You can enter as many as 18 letters including spaces.
Page 213: About Us
9.6 About Us Here you can see the Company name, PDM SN, PDM program version, and code. 9.7 Diagnostics The function “Diagnostics” helps you check if the PDM beeps and vibrates properly. Go to the Diagnostics screen. Main Menu➔ Settings ➔ Diagnostics Select Diagnostics, then tap Next.
Page 214 The PDM will beep three times and vibrate one time while the screen suggests checking alarms. When checking is completed, tap OK to return to the last menu.
Page 215 Warning: If the PDM fails to beep or vibrate, call customer support. To continue using the PDM may put your health at risk. Note: Your PDM uses battery power to beep and vibrate. Checking alarms often will result in reduced battery life and the “CHARGE PDM NOW” Alarm may appear sooner than expected.
Page 216: Safety System And Alarms/Alerts
10 Safety System and Alarms/Alerts 10.1 Safety System Your A6 TouchCare® System (color touchscreen) automatically performs a series of safety checks. The PDM sounds an alert or alarm and displays an on-screen message to let you know of an abnormal condition.
Page 217: Alarms
10.3 Alarms Alarms are triggered by serious or potentially serious conditions. You must respond to the alarm by taking appropriate action in order to clear the alarm condition. For example: When Alarm “PATCH EXPIRED” occurs, the Lock Screen and Alarm screen display the following screen.
Page 218 Audio Mode medium priority alarm PDM emits ten beeps every Audio twenty seconds. PDM emits one-pulse Vibrate vibration every twenty seconds PDM emits three beeps and Audio and Vibrate one-pulse vibration every twenty seconds Audio off / PDM emits one-pulse Vibrate off vibration every twenty seconds...
Page 219: Patch Pump Alarms
Patch Pump emits Patch Pump emits three three beeps and three- beeps and three-pulse Audio and Vibrate pulse vibration every vibration every one one minute. minute. Audio off /Vibrate Patch Pump emits Patch Pump emits three- three-pulse vibration pulse vibration every one every one minute.
Page 220 PDM Message Priority Reason Actions to Take PATCH ERROR A Reservoir Tap to clear it. Delivery Patch error is Change Patch. stopped. Change detected. Check blood glucose. Patch now. PUMP BASE Tap to clear it. ERROR Remove Pump. A Pump Base Remove Pump.
Page 221: Pdm Alarms
Tap to clear it. You have Check blood glucose. EXCEEDS MAX attempted to Resume basal 1HR DELIVERY deliver more delivery. Exceeds 1 hour insulin than Check bolus history max. Delivery expected based and reevaluate your stopped. on your Hour need for insulin. Max setting.
Page 222: Alerts
Tap to clear it. A PDM software Remove the Patch PDM ERROR error is detected Pump and change a The PDM has and the PDM has Reservoir Patch. restarted. Change restarted, but no If the problem occurs patch. settings have repeatedly, please been changed.
Page 223 CGM Alerts and PDM Alerts in different audio modes: Audio Mode Alert Audio PDM emits two beeps every three minutes. PDM emits one-pulse vibration every three Vibrate minutes. PDM emits two beeps and one-pulse Audio and Vibrate vibration every three minutes. Audio off /Vibrate off no beeping, no vibration Patch Pump Alerts in different audio modes:...
Page 224: Patch Pump Alerts
The sound wave of every alert beep: Icon Sound wave Significance Your PDM emits two beeps every time. 10.4.1 Patch Pump Alerts When a Patch Pump alert occurs: Indicator light: The indicator light on the Patch Pump flashes yellow once every two seconds until the alert is cleared.
Page 225: Cgm Alerts
delivered. Basal soon. delivery can only last about 30 minutes. The Sensor glucose Tap to clear it. PRE LOW SUSPEND may reach the Low Check blood Delivery suspended. Glucose Suspend glucose and Predictive low Limit in the length treat it as glucose.
Page 226 PDM Message Priority Reason Actions to Take bumped or dislodged, make sure that the Sensor is inserted correctly or change Sensor. The current SENSOR EXPIRED Sensor has Sensor session Tap to clear it. reached its 7- ended. Change Change Sensor. day or 14-day Sensor.
Page 227 PDM Message Priority Reason Actions to Take Glucose may reach reach Low Check blood Low Limit in [ ] min. Glucose Limit in glucose and treat the length of it as necessary. time. Continue to monitor blood glucose. Tap to clear it. The Sensor Check blood glucose may...
Page 228: Alert Silence
PDM Message Priority Reason Actions to Take The current SENSOR EXP IN 2 Sensor session Tap to clear it. HOURS has 2 hours left Change Sensor in Change Sensor in 2 until its period 2 hours. hours. ends. The current SENSOR EXP IN 30 Sensor session Tap to clear it.
Page 229 If the Audio and Alert Silence are on, the temporary audio off icon” ”will appear in the top right corner of this screen. If the Audio is off, the audio off icon” ”will appear in the top right corner of this screen.
Page 230: Pdm Alerts
10.4.4 PDM Alerts When “LOST SENSOR” occurs, your PDM emits three-pulse vibration every three minutes. Your PDM will not beep or vibrate for all the other PDM alerts. The following table lists alert messages for PDM. PDM Message Priority Reason Actions to Take PDM BATTERY Tap to clear it.
Page 231: Reminders
PDM Message Priority Reason Actions to Take Call customer support if you have any questions. 10.5 Reminders Reminders are automatically displayed to remind you of a condition, function or event. A Reminder requires you to press buttons to clear it and/or to take action if necessary.
Page 232 Reason Condition PDM Message The blood glucose entered is Treat low BG. Monitor LOW BG lower than 3.9 mmol/L (70 mg/dL). BG Reminder is turned on to CHECK BG Check your BG. remind you to check meter BG after a bolus. Bolus Reminder is turned on to BOLUS Bolus is not delivered in...
Page 234: Troubleshooting
The Bluetooth protocol. Bluetooth Low Energy (BLE) in specific. Can I take a sauna with the A6 TouchCare System (color touch screen) on? Firstly, the operating temperature range for the Patch Pump, PDM and Transmitter is +5°C ~ +40°C.
Page 235 If one of the following alerts happened, the PDM would beep/vibrate and display a message first, and if you missed that alert, later when you checked the PDM, the condition that triggered the alert had changed (for example, your glucose level returned to the target range), then you wouldn't see any message on the screen, you would only find it in History.
Page 236: Troubleshooting Pdm Issues
11.2 Troubleshooting PDM issues Charging the PDM We recommend that you charge the PDM when a PDM BATTERY LOW alert happens. PDM does not power on after you press the Power button. 1. PDM battery is too low. You can charge the PDM. 2.
Page 237: Troubleshooting Cgm Issues
11.4 Troubleshooting CGM issues Charging the Transmitter We recommend that you charge the Transmitter after each Sensor session, or make sure that at least 1 minute has passed before you attach the Transmitter to a new Sensor. Green lights after installing the Transmitter After you install the Transmitter, the green light on the Transmitter will flash 3 times immediately indicating that the Transmitter is properly connected with the Sensor, and flash another 6 times within one minute indicating that the...
Page 240: Manufacturer's Declaration
12 Manufacturer’s Declaration The A6 TouchCare® System (color touch screen), consisting of the MD-FM-008 PDM, MD-JN-012 Pump Base, MD-JN-011 Reservoir Patch, MD-TY-012 Transmitter and MD-JY-006/JY-016 Glucose Sensor, is intended for use in the electromagnetic environment specified below. The customer or the user of A6 TouchCare®...
Page 241 Warning: 1. Medtrum MD-SY-011C system is not designed to be used in an environment with high voltage, high-intensity magnetic field, where the intensity of EM DISTURBANCES is high. 2. Portable RF Communications equipment should be used no closer than 30 cm (12 inches) to any part of the Medtrum products.
Page 242: Appendix I: Symbols And Icons
13 Appendix I: Symbols and Icons 13.1 Product Label Symbols Symbol Meaning Symbol Meaning Do NOT use if Lot number package is damaged Reference Sterilized using STERILE EO number ethylene oxide Sterilized using Manufacturer radiation Use by: (yyyy- Follow instructions mm-dd) for use Caution: See...
Page 243: Pdm Icons
Symbol Meaning Symbol Meaning Authorized Waste Electrical representative in and Electronic the European Equipment Community Protection Against Insertion of Large IP22 Objections and Dripping Water IEC 60529 13.2 PDM Icons Icon Meaning Icon Meaning High priority Medium priority alarm alarm Alert Audio off Audio...
Page 244: Appendix Ii: Technical Information
14 Appendix II: Technical Information 14.1 Patch Pump Specifications Model: Pump Base: MD-JN-012 Reservoir Patch: MD-JN-011 Size: 56.5mm x 33.3mm x 13.3 mm Weight: 21.5 g (without insulin) Operating Temperature Range: +5 °C ~ +40 °C Operating Relative Humidity Range: 20%~90%RH Operating Atmospheric Pressure: 700~1060 hPa Storage Temperature Range: -10°C ~ +55°C Storage Relative Humidity Range: 20%~90%RH...
Page 245 Delivery Accuracy: Basal: +/- 5% (at rates: 0.1~ 10 U/h) Bolus: +/- 5% (for all set values: 0.05 ~ 25 U) Accuracy Test Results (test cycle: 29 H, delivery rate: 1.0 U/H, average error: 0.40%): Note: The Patch Pump may not be able to achieve the above measurement accuracy under certain circumstances such as vigorous exercise, or abnormal operating conditions.
Page 246: Pdm Specifications
14.2 PDM Specifications Model: MD-FM-008 Size: 76.2 x 48.4 x 9.375mm Weight: 42.4 g Screen: 2.4 in Operating Temperature Range: +5°C ~ +40°C Operating Relative Humidity Range: 20%~ 90%RH Operating Atmospheric Pressure: 700~1060 hPa Storage Temperature Range: -10°C ~ +55°C Storage Relative Humidity Range: 20%~ 90%RH Storage Atmospheric Pressure: 700~1060 hPa Classification: Internally powered, Continuous operation...
Page 247: Glucose Sensor Specifications
Battery: Built-in 3.7 V polymer lithium ion battery Waterproof Rating: IPX8 (2.5 m, 60 min) Classification: Type BF equipment, Continuous operation Data Storage: Automatically stores the previous 14 days’ data Wireless Communication Distance: 10 m Limited Warranty: 1 year 14.4 Glucose Sensor Specifications Model: MD-JY-006 Storage Temperature Range: +2°C ~+30°C Storage Relative Humidity Range: 20%~90%RH...
Page 248 Table. Percentage of CGM Glucose Readings within ±20%/20 mg/dL , ±30%/30 mg/dL, or ±40%/40 mg/dL of the YSI; Calibrating every 12 hours, Abdomen insertion site. Number of ±40%/40 Matched Pairs ±20%/20 mg/dL ±30%/30 mg/dL mg/dL CGM-YSI 1678...
Page 250: Glossary
15 Glossary Basal Pattern A set of one or more basal rates that covers a 24-hour period. Basal Rate The amount of continuous basal insulin that is automatically delivered every hour. Abbreviation for blood glucose. See Blood Glucose. BG Target The high and low values to which your blood glucose is corrected when using the Bolus Calculator.
Page 251 Combo Part of the bolus amount delivered immediately and the remainder delivered evenly over time Combo Bolus period. Continuous Glucose A Sensor is inserted under the skin to check Monitoring (CGM) glucose levels in interstitial fluid. A Transmitter sends Sensor glucose readings to a display device.
Page 252 Max 1h Delivery Set the maximum insulin amount that can be delivered in one hour. Max Bolus Set the maximum bolus amount that can be delivered in one dose. Max Total Daily Dose Set the maximum insulin amount that can be (TDD) delivered in one day.
Page 255 UG882111GB 348300 Version: 2.23...

Medtrum A6 TouchCare User Manual

1 Introduction

2 Your A6 Touchcare® System (Color Touchscreen)

3 How to Use the PDM

4 How to Change the Reservoir Patch

5 Advanced Pump Features

6 How to Change the Sensor (Optional)

7 CGM Features (Optional)

8 Easyloop Technology (Optional)

9 Settings

10 Safety System and Alarms/Alerts

11 Troubleshooting

12 Manufacturer's Declaration

13 Appendix I: Symbols and Icons

14 Appendix II: Technical Information

15 Glossary

Quick Links

Troubleshooting

Need help?

Questions and answers

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Summary of Contents for Medtrum A6 TouchCare