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1 | User Manual-1 | Users Manual | 4.00 MiB | February 20 2020 |
B ureau Veritas A7+ TouchCare Insulin Management System User Guide 2019, Medtrum Technologies Inc. All rights reserved. B ureau Veritas Humalog is a trademark of Eli Lilly and Company. NovoRapid is a trademark of Novo Nordisk A/S. Apidra is a trademark of Sanofi S.A. Medtrum Technologies Inc. 7F, Building 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 0197B ureau Veritas 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 1.4.1 Warnings and Precautions ............................................................ 2 1.4.2 Consumables ................................................................................. 5 1.4.3 Radio Frequency (RF) Communication .......................................... 6 1.4.4 Emergency Kit ............................................................................... 6 1.4.5 Water ............................................................................................ 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 and country/region ........................................... 22 i B ureau Veritas 3.2.2 Time and Date ............................................................................. 23 3.2.3 Bolus Calculator ........................................................................... 24 3.3 Home Screen ............................................................................... 25 3.3.1 Status Bar Icons ........................................................................... 26 3.3.1.1 Battery Icon ..................................................................................... 26 3.3.1.2 Time Icon ........................................................................................ 26 3.3.1.3 Audio Icon ....................................................................................... 27 3.3.1.4 Pump RF Signal Icon ........................................................................ 27 3.3.1.5 Alert Icons ....................................................................................... 27 3.3.2 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 ii B ureau Veritas 3.9.2 Insulin Injection ........................................................................... 43 3.9.3 Carbohydrates Information ......................................................... 43 3.9.4 Physical Exercise Information ..................................................... 44 3.9.5 Health Information ...................................................................... 45 3.9.6 Other Events................................................................................ 45 3.10 History ......................................................................................46 3.10.1 Pump History ............................................................................. 47 3.10.2 Sensor History ........................................................................... 47 3.10.3 PDM Alert History ..................................................................... 47 3.10.4 Event History ............................................................................. 48 3.10.5 BG History ................................................................................. 48 3.10.6 Summary History ....................................................................... 49 3.10.6.1 Summary History: 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 Reminder .................................................................... 55 3.11.3.6 User Settings ................................................................................. 55 3.11.3.7 Passcode Lock ............................................................................... 60 3.11.4 Reminders ................................................................................. 62 3.11.4.1 Personal Reminder ........................................................................ 62 iii B ureau Veritas 3.11.4.2 Bolus Reminder ............................................................................. 64 3.11.4.3 BG Reminder ................................................................................. 64 3.11.4.4 Cal Reminder ................................................................................. 64 3.11.5 Username .................................................................................. 64 3.11.6 Telephone .................................................................................. 65 3.11.7 Diagnostics ................................................................................ 66 3.11.8 About Us .................................................................................... 68 3.12 Troubleshooting ........................................................................ 68 4 How to use Patch Pump ............................................................ 71 4.1 Change the reservoir patch .......................................................... 71 4.1.1 Before Changing the Reservoir Patch .......................................... 71 4.1.1.1 Deactivate the Current Reservoir Patch ......................................... 72 4.1.1.2 Remove the Current Reservoir Patch ............................................. 73 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 Edit Your Standard Basal Pattern ................................................ 96 4.3.3 Check the Current Basal Rate ...................................................... 98 4.3.4 Review Your Basal Patterns ......................................................... 99 4.3.5 Delete a time segment of Basal Pattern ................................... 100 iv B ureau Veritas 4.3.6 Change the time of the Basal Pattern ....................................... 101 4.3.7 Maximum Basal Rate................................................................. 103 4.4 Suspend and Resume ................................................................. 104 4.4.1 Suspend Insulin Delivery ........................................................... 104 4.4.2 Resume Insulin Delivery ............................................................ 107 4.5 Insulin Pump Settings ................................................................ 108 4.5.1 Add/Change the Pump Base SN ................................................ 108 4.5.2 Bolus Setup................................................................................ 109 4.5.3 Basal Setup ................................................................................ 110 4.5.4 Pump Alerts ............................................................................... 111 5 Advanced Pump Features ....................................................... 115 5.1 Bolus Calculator ......................................................................... 115 5.1.1 How the Bolus Calculator Works............................................... 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 ............................................................... 134 5.5.2 Cancel a Temp Basal .................................................................. 135 5.6 Preset Temp Basal ..................................................................... 136 5.6.1 Preset Temp Basal Setup ........................................................... 136 5.6.2 Activate a Preset Temp Basal .................................................... 137 5.7 Reminder .................................................................................. 138 5.7.1 Bolus Reminder ......................................................................... 138 v B ureau Veritas 5.7.2 BG Reminder ............................................................................. 139 5.8 Pump History ............................................................................ 140 5.8.1 Pump History ............................................................................. 140 5.8.1.1 Delivery History ............................................................................. 141 5.8.1.2 Alert History .................................................................................. 145 5.8.2 Pump Summary History ............................................................. 145 5.8.2.1 Summary History: Insulin History ................................................. 145 5.8.2.2 Summary History: Bolus History ................................................... 146 5.9 Troubleshooting Pump issues .................................................... 146 6 How to use CGM system (Optional) ......................................... 151 6.1 Glucose Alerts ........................................................................... 151 6.2 Change Sensor .......................................................................... 151 6.2.1 Disconnect Sensor from Your PDM ........................................... 151 6.2.2 Remove the Current Sensor and Disconnect the 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 ........................................................................... 160 6.2.5.8 Remove the Inserter ..................................................................... 160 6.2.5.9 Check the Sensor Support Mount ................................................. 161 6.2.5.10 Discard the Sensor Inserter Safely .............................................. 161 6.2.6 Attach Your Transmitter ............................................................ 161 6.2.7 Connect Sensor to Your PDM .................................................... 162 6.3 Calibrate Your Sensor ................................................................ 164 vi B ureau Veritas 6.3.1 Enter Your Meter BG ................................................................. 165 6.3.2 Set Calibration Repeat .............................................................. 167 6.3.3 Calibration Reminder ................................................................ 167 6.4 CGM System settings ................................................................. 168 6.4.1 CGM Feature on/off .................................................................. 168 6.4.2 Set the Transmitter SN .............................................................. 169 6.4.3 Graph Range .............................................................................. 170 6.4.4 Cal Repeat ................................................................................. 170 6.4.5 Alert Silence .............................................................................. 170 6.4.6 Sensor Expired ........................................................................... 171 6.5 Sensor History ........................................................................... 172 6.5.1 Sensor History ........................................................................... 172 6.5.1.1 Data History .................................................................................. 172 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 ................................................................ 192 7.2 Summary History: Low Suspend History ..................................... 194 7.3 Troubleshooting Low Suspend issues ......................................... 195 8 Safety System and Alarms/Alerts ............................................ 197 vii B ureau Veritas 8.1 Safety System ........................................................................... 197 8.2 Safety Checks ............................................................................ 197 8.3 Alarms ...................................................................................... 197 8.3.1 PDM Alarms ............................................................................... 200 8.3.2 Pump Alarms ............................................................................. 201 8.4 Alerts ........................................................................................ 203 8.4.1 PDM Alerts ................................................................................ 205 8.4.2 Pump Alerts ............................................................................... 205 8.4.3 CGM Alerts ................................................................................ 206 8.5 Reminding messages ................................................................. 211 8.5.1 PDM reminding messages ......................................................... 212 8.5.2 Pump reminding messages ....................................................... 212 8.5.3 CGM reminding messages ......................................................... 213 9 Manufacturers 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 .................................................. 231 11.5 CGM System Accuracy ............................................................. 231 12 Glossary ................................................................................ 235 viii B ureau Veritas 1 Introduction 1.1 Before you begin Check with your healthcare provider (diabetes team) regarding your individual training needs. Do NOT attempt to use the A7+ TouchCare System before you have been properly trained. As part of your training, your healthcare provider will work with you to establish diabetes management guidelines and settings that best fit your needs. Your healthcare provider can provide you with the initial settings of your insulin Pump and CGM system. After adequate training and practice, you will find it easy to enter and change the systems settings. The A7+ TouchCare Pump is designed to use U-100 insulin. The following insulin analogs have been tested and found to be safe for use in with the A7+
TouchCare Pump: Humalog, NovoRapid, and Apidra. 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 measures the glucose level of interstitial fluid. The Transmitter wirelessly transmits your real-time Sensor glucose information to your Personal Diabetes Manager (PDM). Not all devices or accessories are available in all countries where the A7+
TouchCare System is approved. To order supplies, contact your local representatives. 1.2 Indications The A7+ 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. 1 B ureau Veritas The Patch Pump is indicated for the continuous subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The CGM System is indicated for continuous monitoring of interstitial fluid glucose levels, and detecting possible low and high glucose episodes. Interpretation of the CGM System results should be based on the glucose trends and several sequential readings. 1.3 Contraindications The A7+ TouchCare System is not recommended for people who are unwilling or unable to:
Maintain contact with their healthcare provider. Test their blood glucose levels as recommended by their healthcare provider. Maintain sufficient diabetes self-care skills. Recognize and respond to alerts and alarms. (Sufficient 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 systems performance. If you do not understand something or have questions, ask your healthcare provider, call customer support, or contact your local Medtrum distributor. The A7+ 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 advanced self-care skills. Do NOT use the A7+ TouchCare System until you have specific information for your treatment plan and have had specific training on each feature from your healthcare provider or local Medtrum distributor. 2 B ureau Veritas General Precautions Do NOT put skin care products on the A7+ TouchCare System, that might result in damage to the plastic surface of the products. Wipe off the skin care products such as sunscreen by using a clean cloth. If you find a crack in any part of the A7+ TouchCare System, contact customer support. The A7+ TouchCare System includes active medical devices. When you dispose of any device in the A7+ TouchCare System, follow the local waste disposal regulations. We recommend that you have someone around you (family, friends, etc.) who understands diabetes and the A7+ TouchCare System, so that in case of an emergency, they can help you. Make sure that they are familiar with any information given by your healthcare provider. General Warnings No modification of this system is allowed. Do 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 and Sensor contain small parts and could pose a choking hazard. Do NOT operate your A7+ TouchCare System in the presence of flammable anesthetics or explosive gases. Patch Pump Precautions Contact your healthcare provider about lifestyle changes such as starting/stopping your exercise program or significant weight loss/gain because this can affect the way that your body uses insulin. Patch Pump Warnings In case the A7+ TouchCare System is unable to properly deliver insulin you must be prepared to give yourself an injection of insulin. Knowing how to do 3 B ureau Veritas this will help to avoid the risk of diabetic ketoacidosis (DKA) or very high blood glucose (BG). Do NOT stop using your Pump if you are ill unless instructed to do so by your healthcare provider. Even when you are ill, your body still needs insulin. If failure or damage of your Pump Base is found during usage, please contact customer support or your local Medtrum distributor for replacement. CGM System Precautions The Sensor may create special needs regarding your medical conditions or medications. Please discuss these conditions and medications with your healthcare provider before using the Sensor. If failure or damage of your Transmitter is found during usage, please contact customer support or your local Medtrum distributor for replacement. CGM System Warnings Do NOT ignore symptoms of high or low glucose. If you believe your Sensor glucose readings are inconsistent with how you feel, manually measure your blood glucose with a blood glucose 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 purse, remember to press the power button to put the PDM on sleep mode, so that you can avoid misoperation resulting from accidental bumps and movements. Press the power button again to wake the screen. Check your PDM occasionally to make sure that it emits audible beeps that are easily detectable and that the vibrate feature is working properly. If you return your PDM for service, a replacement PDM will be sent. Do NOT use the replacement PDM until it has been programmed to fit your specific needs. If you drop your PDM or if it has been hit against something hard, check whether the display screen and the touch screen are working properly, whether the PDM can be charged normally. Call customer support or your local Medtrum 4 B ureau Veritas distributor if you identify or suspect your PDM has been damaged. Your PDM is designed to be charged by matching charger. Use of anything other than a charger that does not match could permanently damage your PDM and voids its warranty. Operating Temperature Range Your A7+ TouchCare System is designed to operate between 5C (41F) and 40C (104F). Do NOT expose the system to temperatures outside that range. Do NOT expose the system to direct sunlight for a long period of time. Cleaning Do NOT use household cleaners, chemicals, solvents, bleach, scouring pads or sharp instruments to clean your PDM, Pump Base, or Transmitter. Never put your PDM, Pump Base or Transmitter in the dishwasher or use very hot water to clean it. Do NOT use a hair dryer, microwave oven, or conventional oven to dry your PDM, 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 the Reservoir Patch and Sensor after the test or procedure is completed. The A7+ TouchCare System is designed to tolerate common electromagnetic and electrostatic fields, including airport security systems and mobile phones. 1.4.2 Consumables Reservoir PatchThe Pump Base (JN-022) is only used with the 200-unit Medtrum Reservoir Patch (MD-JN-011). Change your Reservoir Patch every 2-3 days or as directed by your healthcare provider. Glucose SensorThe Transmitter (MD1026) is used with the Medtrum Glucose Sensor (MD3026). Change your MD3026 Glucose Sensor every fourteen days. 5 B ureau Veritas Warning: For your protection the Pump Base and Transmitter have undergone extensive testing to confirm appropriate operation when used with consumables manufactured or distributed by Medtrum. We recommend using Medtrum Reservoir Patches and Glucose Sensors as we cannot guarantee appropriate operation if the system is used with consumables offered by third-
parties and therefore we are not responsible for any injury or malfunctioning of the system that may occur in association with such use. 1.4.3 Radio Frequency (RF) Communication Note: The A7+ TouchCare System can generate, use and radiate radio frequency energy, and may cause harmful radio communications. There are no guarantees that interference will not occur in a particular installation. If the A7+ TouchCare System does cause harmful interference to radio or television reception, you are encouraged to try to correct the interference by one of the following measures:
interference to 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 Transmitter. This interference, however, does not cause any incorrect data to be sent and does not cause any harm to your device. Based on GFSK modulation, the system communicates at frequencies between 2402 and 2480 MHz with power level 0 dBm. RF communication between your Patch Pump and PDM works up to a distance of 4 meters (13 feet). RF communication between your Transmitter and PDM works up to a distance of 10 meters (33 feet). 1.4.4 Emergency Kit Keep an emergency kit with you at all times to make sure you have necessary supplies. Inform a family member, co-worker, and/or friend where this emergency kit is kept. This kit should include but is not limited to:
6 B ureau Veritas Fast-acting glucose tablets or gel BG monitoring supplies 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 Alcohol wipes Glucagon emergency kit Emergency contact phone numbers 1.4.5 Water Both your Patch Pump and Sensor (including the installed Transmitter) are waterproof to a depth of 2.5 meters (8 feet) for up to 60 minutes (IPX8). After exposure to water, rinse the devices with clean water and dry them with a towel. Warning: Do NOT expose your Patch Pump or Sensor (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 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 -10C (14F) and 55C (131F), and at humidity levels between 20% and 90% relative humidity. Do NOT store the Pump Base and Reservoir Patch in direct sunlight, extreme temperatures, or in very humid areas. 7 B ureau Veritas Store the Sensor at temperatures between 2C (36F) and 30C (86F), and at humidity levels between 20% and 90% relative humidity for the length of the Sensors shelf life. For temperatures greater than 30C (86F), the Sensor will require cooled storage at temperatures no lower than 2C (36F). You may store the Sensor in the refrigerator if it is within this temperature range. The Sensor should not be stored in the freezer. Wait for the Sensor to warm to room temperature before usage to prevent condensation. Storing the Sensor improperly may cause the Sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value. Store the Transmitter at temperatures between -10C (14F) and 55C (131F), and at humidity levels between 20% and 90% relative humidity. Keep the USB charging cable and the Transmitter separate when in storage. Store the Personal Diabetes Manager (PDM) at temperatures between -10C
(14F) and 55C (131F), and at humidity 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 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. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or 8 B ureau Veritas television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
-Reorient or relocate the receiving antenna.
-Increase the separation between the equipment and receiver.
-Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
-Consult the dealer or an experienced radio/TV technician for help. RF warning for Portable device. The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. 1.4.8 IC Caution This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions:
(1) This device may not cause interference, and (2) This device must accept any interference, including 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 discretion, either repair or replace (with a new or recertified PDM, at Medtrums discretion) any defective PDM, subject to the conditions and exclusions stated herein. This Warranty applies only to new devices and, in the event the 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 Medtrums instructions and will not apply:
If damage results from changes or modifications made to the PDM by the user or third persons after the date of manufacture;
If damage results from service or repairs performed to any part of the PDM by any person or entity other than Medtrum;
9 B ureau Veritas If a charger without matching is used with the PDM If damage results from a Force Majeure or other event beyond the control of Medtrum; or If damage results from negligence or improper use, including but not limited to improper storage or physical abuse such as dropping or otherwise. This warranty shall be personal to the original end use purchaser. Any sale, rental or other transfer or use of the PDM covered by this warranty to or by a user other than the original end use purchaser shall cause this warranty to immediately terminate. This warranty only applies to the PDM 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 EXCLUDED, INCLUDING THE WARRANTIES 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 recertified Pump Base, at Medtrums discretion) any defective Pump Base, subject to the conditions and exclusions stated herein. This Warranty applies only to new devices and, in the event the Pump Base is repaired or replaced, the warranty period shall not be extended. The warranty is valid only if the Pump Base is used in accordance with Medtrums instructions and will not apply:
If damage results from changes or modifications made to the Pump Base by the user or third persons after the date of manufacture;
If damage results from service or repairs performed to any part of the Pump Base by any person or entity other than Medtrum;
If a non-Medtrum Reservoir Patch is used with the Pump Base;
If damage results from a Force Majeure or other event beyond the control of Medtrum; or 10 B ureau Veritas If damage results from negligence or improper use, including but not limited to improper storage or physical abuse such as dropping or otherwise. This warranty shall be personal to the original end use purchaser. Any sale, rental or other transfer or use of the Pump Base covered by this warranty to or by a user other than the original end use purchaser shall cause this warranty to immediately terminate. This warranty only applies to the Pump Base 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 EXCLUDED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. Transmitter Medtrum Technologies Inc. (Medtrum) warrants its Transmitter against defects 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 Medtrums discretion) any defective Transmitter, subject to the conditions and exclusions stated herein. This Warranty applies only to new devices and, in the event the Transmitter is repaired or replaced, the warranty period shall not be extended. The warranty is valid only if the Transmitter is used in accordance with Medtrums instructions and will not apply:
If damage results from changes or modifications made to the Transmitter by the user or third persons after the date of manufacture;
If damage results from service or repairs performed to any part of the Transmitter by any person or entity other than Medtrum;
If a non-Medtrum Glucose Sensor is used with the Transmitter;
If damage results from a Force Majeure or other event beyond the control of Medtrum; or If damage results from negligence or improper use, including but not limited to improper storage or physical abuse such as dropping or otherwise. 11 B ureau Veritas This warranty shall be personal to the original end use purchaser. Any sale, rental or other transfer or use of the Transmitter covered by this warranty to or by a user other than the original end use purchaser shall cause this warranty to immediately terminate. This warranty only applies to the Transmitter 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 EXCLUDED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. 12 B ureau Veritas 13 B ureau Veritas 14 B ureau Veritas 2 Your A7+ TouchCare System 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. When RF communication is lost or interrupted because of adverse conditions or overlong distance, you will not be able to use your PDM to control or monitor your Patch Pump or Continuous Glucose Monitoring System. Yet the Patch Pump is able to continue delivering 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. 1. Power button 2. Home Key (Software Key) 3. Charging Port 4. Sound Hole 5. Indicator light Personal Diabetes Manager (PDM) (FM-018) 2.2 Patch Pump The Patch Pump is a small, portable, self-adhesive device worn directly on your body to deliver precise, personalized doses of insulin into your body through a needle. The Patch Pump consists of a reusable Pump Base and a disposable Reservoir Patch. The reusable Pump Base holds the electronics and stores all your Pump settings. The disposable 200 Unit Reservoir Patch incorporates a 15 B ureau Veritas precise dispensing screw, a plunger, an actuator, a needle, a buzzer and a battery to power your Pump. The delivery system and enclosure of the Reservoir Patch are applied parts of the Pump. Reservoir Patch
(MD-JN-011, consumable) Pump Base (JN-
022) 2.3 Glucose Sensing System (Optional) The Glucose Sensing System is an optional part of the A7+ 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. 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 Transmitters USB charging cable or charging dock is also included in the package. Transmitter MD1026, compatible sensor MD3026 and compatible charging cable LQ005 are as follows. 16 B ureau Veritas Glucose Sensor Transmitter
(MD3026, Consumable)
(MD1026, Chargeable) USB charging cable
(LQ005) 17 B ureau Veritas 18 B ureau Veritas 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 screen will light up, the PDM is successfully turned on. When you 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 on for about 2 seconds, indicating that the shutdown is completed. 19 B ureau Veritas 3.1.2 Charge the PDM As a safety measure, the PDM will give you PDM BATTERY LOW or CHARGE PDM NOW alert when you keep the PDM working at a low power level. If you receive a PDM BATTERY LOW alert, respond to the alert and continue. Though the PDM will still function normally, the battery life could be decreased. The PDM requires an AC adapter with an output of DC 5.0V that complies with IEC 60601-1 and IEC 60950 such as UES06WNCPU-050 100SPA, (input: 100-240V, 50/60Hz, 0.2A; output: 5.0V DC, 1.0A). The adapter is designed as a part of the ME system. Note:
Do not use other types of chargers. Otherwise the PDM may 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 required, please contact customer service. Usually, when the PDM is fully charged, it is available for use of one week
(7 days). Blue light flashes when PDM is charging, and the green light is always on indicates full charge. Only person (including patient) with adequate training is permitted to operate the PDM. Charging process:
1. Connect PDM to adapter. 2. Plug the adapter into a power socket. 20 B ureau Veritas 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. The activated basal, temporary basal and all bolus functions will not be 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 Lock Screen. The Alerts and Alarms shall be manually cleared after sliding to unlock. 21 B ureau Veritas An Alarm occurs when the screen An Alarm occurs when the screen is locked. 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. 3.2 Setting up the PDM 3.2.1 Select language and country/region 1. Select your language, then tap Next. 22 B ureau Veritas You can change language. See Language in Section Settings for setup instructions. 2. Select your country/region, then tap Next. 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. You can select a 12-hour or 24-hour clock format. 1. Select your time, then tap Next. 23 B ureau Veritas
(1) Choose the time.
(2) Tap the blue button to increase and to decrease hour on the left. 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. Tap Setup to enter Bolus Calc Setup. Tap Skip to go 24 B ureau Veritas directly to Lock Screen. See Bolus Calculator in Chapter Advanced Pump Feature for more information. 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 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 Delivering Status and Sensor Status. 25 B ureau Veritas Note: At this screen, slide on the screen from right to left, you can open main menu screen. Slide from left to right to open status screen. Slide PDM from top to bottom to open alert notification screen. Slide on the screen from bottom to top to open shortcut screen. 3.3.1 Status Bar Icons 3.3.1.1 Battery Icon The battery icon shows the remaining battery life. When the PDM is not charging There are five icons, indicating 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 select the current time displayed in a 12-hour or 24-hour format. The a or p appears in the 12-hour format. For instructions on setting the time on your PDM. See Time and Date in Section Settings. 26 B ureau Veritas 02:00 p 12-hour format 14:00 24-hour format 3.3.1.3 Audio Icon There are eight kinds of audio icons, indicating different Reminder types, you can set it in the General Settings menu and CGM Settings menu. Audio Vibrate Audio and Vibrate Audio off /Vibrate off Alert Silence + Audio Reminder Alert Silence + Vibrate Reminder Alert Silence + Audio and Vibrate Alert Silence + Audio off /Vibrate off 3.3.1.4 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 3.3.1.5 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 there is an alert or alarm condition in your insulin management system. See Chapter Safety System and Alarms/Alerts for more information. Alert icon Medium priority alarm icon High priority alarm icon 27 B ureau Veritas 3.3.2 Pump Status 1. EasyLoop Icon 2. Insulin Pump Delivering Status 3. IOB (Insulin on Board) 4. Pump RF Signal 5. Insulin left You can view the Pump Status on the Home Screen. Insulin Delivering Status icons in different situations:
Icon Shape and Color Description Grey ring Grey ring indicates that there is no activated Pump. Green ring 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. 28 B ureau Veritas Purple and dark purple ring Purple ring represents the extend Bolus, the deep purple part indicates the progress of delivery. Red ring Red ring represents the delivery suspend status. The status information is indicated by text below:
Basal(U/H) 1.00: The current basal rate is 1.00U/H. Temp Basal(U/H) 1.00: Temp Basal is activated and the active temp basal rate is 1.00U/H. Temp Basal(U/H) 1.00 85%: Temp Basal is activated and the active temp basal rate is 1.00U/H (85% of current basal pattern). Normal(U) 1.00/2.00: Normal 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 delivered | total Extended Bolus programmed:
2.00U. Suspend time remaining 0:15: Suspend is active and basal will resume automatically after 15 minutes. Insulin left: The actual amount of insulin left in the reservoir. 3.3.3 Sensor Status You can view the Sensor Status on the Home Screen. 29 B ureau Veritas Trend arrow 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 The trend arrow shows the speed and direction of your Sensor glucose readings. Stable Slowly-rising Rising Rapidly-rising Slowly-falling Falling Rapidly-falling No arrow No information Calibration Icon If your Sensor is on a 24-hour calibration routine, the calibration icon grows fuller as the time for the next calibration. 30 B ureau Veritas 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. The next calibration is due in 8 to 12 hours. The next calibration is due in 4 to 8 hours. The next calibration is due in 0 to 4 hours. A calibration 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 hours. A calibration is needed now. Data recovery status icon 31 B ureau Veritas 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. Special conditions Under normal Sensor conditions, the most recent 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 glucose is above 22.2 mmol/L (400mg/dL). 32 B ureau Veritas Low - Sensor glucose is below 2.2 mmol/L (40mg/dL). Underlined reading - Calibration overdue. A new meter BG is needed for calibration. Note:
1) When the Sensor is warming up, a progress bar is displayed at the bottom of Home Screen. It takes 120 minutes for each Sensor to warm up. 2) After you enter a meter BG value to calibrate the Sensor, it may take up to 3 minutes for the Sensor to adjust its readings, with the Sensor glucose reading blinking. 3.3.4 EasyLoop 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 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. 33 B ureau Veritas 3.3.5 Sensor Graph The Y-axis of the Sensor graph is featured by four values: 5, 10, 15, 20 mmol/L
(90, 180, 270, 360 mg/dL). The X-axis of the Sensor graph presents a period of the last 3 hours. The Sensor graph can be switched to a landscape screen display. Long tap the Sensor graph for 1 second and the display will turn horizontal. You can see trend graph of your glucose information for the past 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 status will always be shown in the area below, between the left and right arrow button. Special status includes:
calibration error (ERR), no readings (???), warm-up phase (Warm-up), 34 B ureau Veritas Sensor glucose is above 22.2 mmol/L (400mg/dL). (HIGH) and Sensor glucose is below 2.2 mmol/L (40mg/dL). (LOW). After the warm-up phase, the values before the first calibration are replaced by BG. When the Sensor calibration expires, the reading values will be underlined. Calibration will be marked with a red dot . The green square blocks in the graph background represent the Low and High limits of glucose. In the landscape screen display, tap the Home Key to return to the 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 displayed on the Home Screen in this case:
PATCH BATT DEPLETED, PUMP OUT OF RANGE, EMPTY RESERVOIR, PATCH EXPIRED, OCCLUSION DETECTED, PATCH ERROR, AUTO OFF, EXCEEDS MAX TDD, EXCEEDS MAX 1HR, PUMP BASE ERROR, LOW SUSPEND and PRE LOW SUSPEND. For example:
35 B ureau Veritas 3.4 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 and telephone number. See Username and Telephone in Section Settings for more information. The PDM displays the Lock Screen after display timeout. When the screens 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 36 B ureau Veritas See Chapter Safety System and Alarms/Alerts for more information about Alarm, Alert or Reminder status. 3.5 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. 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 from bottom to top from Home Screen to call the Shortcut Screen. 37 B ureau Veritas 1) Calibration Shortcut icon 2) Bolus Shortcut icon If the Food/Correction Bolus function is turned on, then youll enter Food/Correction Bolus by tapping this icon. If not, youll enter Manual Bolus by tapping this icon. 3) Audio Option icon There are two icons of Audio Option, each changing after one tap: Audio 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 systems 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. 38 B ureau Veritas The Status Screen displays the following information. Delivery/Today Bolus Basal Other Status Info Device Info 39 B ureau Veritas 3.8 Menus The Main menu consists of nine sub-menus: Bolus, Basal, Suspend, Patch, Sensor, History, Events, 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. 3.8.1 Bolus The Bolus menu contains the settings 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 Bolus is being delivered, you can suspend Basal delivery for a set period of time by tapping Suspend icon. 40 B ureau Veritas When a Bolus is being delivered, with the Suspend function you can suspend Bolus or all insulin deliveries (basal and bolus) for a set period of time. See Section Suspend and Resume in Chapter How to use Patch Pump for more information. 3.8.4 Patch You can change your Reservoir Patch and check Pump Base SN on Patch menu. See Chapter How to use Patch Pump for more information. 3.8.5 Sensor The Sensor menu contains calibration and connection functions of the Glucose Sensor. See Chapter How to use CGM system for more information. 3.8.6 History On the History menu you 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 menu is used to set Glucose Alerts and (Pre) Low Suspend functions. See Chapter How to use (P)LGS for more information. 3.8.9 Settings On the Settings menu you can edit personal settings of your system. See Section Settings in this chapter for more information. 3.9 Events The A7+ TouchCare System is able to record different events including blood 41 B ureau Veritas 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. Go to Events Screen. You can select event type you want to record. Main MenuEvents 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 is 40 - 400 mg/dL (or 2.2 - 22.2 mmol/L). 42 B ureau Veritas 5. When finished, tap Save to confirm input. Or press to cancel. 3.9.2 Insulin Injection 1. Select Injection in the Events screen. 2. Choose the date and time for insulin injection. 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. 43 B ureau Veritas 2. Choose the date and time for carbohydrate intake. 3. Tap Carbs value to select the carbohydrates you eat or drink. The input range is 0-200 grams. 4. When finished, tap Save to confirm or press to cancel. 3.9.4 Physical Exercise Information 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 to cancel. 44 B ureau Veritas 3.9.5 Health Information 1. Select Health in the Events screen. 2. Choose the date and time for health information 3. Tap Health option to select the physical condition. You can 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. 45 B ureau Veritas For example, when you want to enter a, tap abc and select a. Tap ABC to switch to capital. 4. Tap and choose the letters for text input. Note: 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 MenuHistory 46 B ureau Veritas 3.10.1 Pump History On the Pump History menu you can review Pump History. See Section Pump History in Chapter Advanced Pump 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 MenuHistoryPDM HistoryPDM Alert History 47 B ureau Veritas Tap the date to switch between records of different dates. Tap each Alert to view alert detail information. Tap to return to the previous menu. See Alert Icons for more information about how to address alarms and alerts and the meanings of different alarm/alert icons. 3.10.4 Event History Go to the Event History screen. Main MenuHistoryEvent 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 MenuHistoryBG History 48 B ureau Veritas BG History contains BG from Calibration , Event BG and BG input during Bolus delivery through Bolus Calculator . Tap the date or , to switch between records of different dates. 3.10.6 Summary History The Summary 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 MenuHistorySummary 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 . 49 B ureau Veritas 3.10.6.1 Summary History: Insulin History See Section Pump Summary History in Chapter Advanced Pump Features for more information. 3.10.6.2 Summary History: Bolus History See Section Pump Summary History in Chapter Advanced Pump Features for more information. 3.10.6.3 Summary History: BG History This screen displays the BG result summary history. Main MenuHistorySummary HistoryBG 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 Summary History: Low Suspend History See Section Low Suspend History in Chapter How to use (P)LGS for more information. 50 B ureau Veritas 3.11 Settings 3.11.1 CGM System (Optional) Tap CGM System on the Settings screen to enter the CGM System screen. 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 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 Options, Display, Confidence Reminder, User Settings. 51 B ureau Veritas 3.11.3.1 Language You can change your PDM Language. Main Menu SettingsGeneralLanguage 3.11.3.2 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. Note: As a safety feature, you can only change the date and time when there is no active Reservoir Patch or connected Sensor. 1. Go to the Time/Date Setup screen. 52 B ureau Veritas Main Menu SettingsGeneralTime/Date If you turn the switch on, the time is set as 24-hour-format. 2. Date keyboard and Time keyboard 3.11.3.3 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. If Vibrate is selected, both your PDM and Patch Pump will vibrate when an alert occurs. 53 B ureau Veritas 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 Patch Pump will make a siren sound until the alarm is cleared. When BELOW 3.1mmol/L (BELOW 56mg/dL) occurs, your 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 MenuSettingsGeneralAudio Options 3.11.3.4 Display You can set your screen display time between 30 sec, 1 min and 2 min. You can also set the brightness of the screen. 54 B ureau Veritas Slide or tap to adjust the brightness, you can choose between 10 brightness levels. Lower level consumes less power. 3.11.3.5 Confidence Reminder If this feature is turned on, the PDM will beep and/or vibrate in response to your instructions, including:
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 3.11.3.6 User Settings You can use this feature to save, restore or reset all PDM settings. Sensor connected Insulin delivery has been suspended Basal insulin has been resumed Glucose alert set Pump alert/alarm set Tapping the HOME key 55 B ureau Veritas 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:
1. 2. 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:
56 B ureau Veritas Read the instructions on the screen; then tap Next to save your current settings. 3. 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. 1. Select Restore in User Settings screen. 2. Read the instructions on the screen, and then tap OK to restore the settings. 57 B ureau Veritas 3. 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. Take the following steps to reset PDM settings:
1. Select Reset in the User Settings screen. Then select Yes. 58 B ureau Veritas 2. 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. 1. 2. Select Settings History in User Settings screen. Slide to scroll up/down to view the entire settings history. 59 B ureau Veritas 3.11.3.7 Passcode Lock The passcode lock function is a safety feature that prevents improper operation by unintended user. Main Menu SettingsGeneralPasscode Lock Tap Set Passcode, enter the old passcode and then set a new one. 60 B ureau Veritas Enter the 4-digit passcode. Note: The default passcode is 0000. Enter the new passcode twice. 61 B ureau Veritas 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. 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 Personal Reminder option is turned on. Go to the Personal Reminder screen. 62 B ureau Veritas Main MenuSettingsRemindersPersonal Reminder 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. 63 B ureau Veritas 3.11.4.2 Bolus Reminder See Section Reminder in Chapter Advanced Pump Features for more information. 3.11.4.3 BG Reminder 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. 2. Tap ------ to enter your username. Main MenuSettings Username 64 B ureau Veritas
(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. 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. 2. Tap ------ to enter your telephone number or emergency-call number. Main MenuSettings Telephone 65 B ureau Veritas
(1) Use the keyboard to enter the telephone number .
(2) When finish, tap Done.
(3) Tap the number in blue to edit telephone number again. Note: You can enter as many as 18 letters including spaces. The PDM displays the Telephone 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. 66 B ureau Veritas 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. 67 B ureau Veritas 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. 3.11.8 About Us Here you can see the Company name, PDM 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 Energy (BLE) in specific. Can I take a sauna with a PDM?
No. The operating temperature range for the PDM is +5C ~ +40C. Charging the PDM 68 B ureau Veritas 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. Charge the PDM. 2. PDM is outside of its operating temperature range. Move the PDM to a temperature between +5C ~ +40C and then try to power it on. 69 B ureau Veritas 70 B ureau Veritas 4 How to use Patch Pump 4.1 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. Use of the device with inadequate training or improper setup could put your health and safety at risk. Your healthcare provider will help you set up and apply your first Patch Pump if you are a first-time A7+ Patch Pump user. Warning: Use an aseptic technique when you are preparing, filling, attaching, or removing a Reservoir Patch. This means to:
1. 2. 3. 4. wash your hands with soap and water clean the insulin vial with an alcohol wipe clean the infusion site with an alcohol wipe 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 doesnt have enough insulin to cover your night time insulin needs. 4.1.1 Before Changing the Reservoir Patch You will need these items before you begin:
Vial of rapid-acting U-100 insulin An unopened Reservoir Patch A Pump Base Alcohol wipe(s) A 2mL disposable sterilized syringe with a capped needle
Warning: Using an insulin type other than rapid-acting U-100 insulin, or using insulin that is expired or inactive, may lead to hyperglycemia or diabetic ketoacidosis (DKA). Do NOT use insulin that is cloudy because it may be inactive. 71 B ureau Veritas 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) Make sure that the syringe with fill needle has been properly sterilized. Warning: A Reservoir Patch that has not 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 Base from the Reservoir Patch. Main Menu Patch Deactivate Patch. 1. Slide to Deactivate current Reservoir Patch. Tap or Home Key to cancel this operation. 72 B ureau Veritas 2. Several seconds later, you will see a message showing that the Patch has been deactivated. 4.1.1.2 Remove the Current 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. 73 B ureau Veritas 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. 2. Press and hold the two release buttons on both ends of the Pump Base and pull the Pump Base off the old Reservoir Patch. Discard 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 MenuPatch Pump Base SN Note: Dont forget to update the SN if you change to a new Pump Base. Note: You can only change the Pump Base SN when there is no active Reservoir Patch. You can find Pump Base SN on the product box or on your Pump Base. 74 B ureau Veritas 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 Tap --------- or the existing Pump base SN, you will see the following screen. Then enter the SN to your PDM and tap Done. 75 B ureau Veritas 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. Make sure that 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. 76 B ureau Veritas If your PDM finds multiple Pumps, the SNs wont be displayed to prevent you from selecting the wrong SN. Tap OK to go back to Patch Menu, then select --------- to enter the SN manually. 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. 4.1.2 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 MenuPatchNew Patch 77 B ureau Veritas 4.1.3 Connect the Pump Base to a New Reservoir Patch 1. 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. 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. 78 B ureau Veritas 3. The Pump performs a series of safety checks immediately after the two parts are connected. The safety checks take about twenty seconds. The indicator light flashes in the order of blue, green, yellow, and red, and the Pump beeps four times. 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. 4.1.4 Fill the New Reservoir Patch Warning: 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, and other Reservoir Patches. The Patch Pump will detect the volume of insulin in the reservoir once it is filled, and if the Patch Pump is in a magnetic field, the volume detected can be inaccurate. Take the following steps to fill a new Patch:
1. Clean the top of the insulin vial with an alcohol wipe. 2. Remove the protective cap from the needle. Keep the cap. 79 B ureau Veritas 3. With the help of your healthcare provider, decide on the amount of insulin
(70 U-200 U) you need to insert into the Reservoir Patch. 4. Draw air into the syringe up to the amount of insulin you need. 5. Insert the needle into the insulin vial and push down on the plunger to pressurize the vial. 6. 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. 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 that you insert the syringe perpendicularly rather than at an angle into the insulin fill port. 8. Keep the syringe vertical to the Patch Pump, and the needle inside the fill port, pull back on the plunger until it is fully retracted. This will remove any residual air from the reservoir. Bubbles will rise toward the plunger. 80 B ureau Veritas 9. Make sure that the needle is still in the fill port and release the plunger. Pressure will pull the plunger to its neutral position, but it will NOT push any air back inside the reservoir. 10. Withdraw the needle from the fill port. Turn 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 the plunger. 81 B ureau Veritas Warning: Do NOT use a Reservoir Patch if you hear a crackling noise or feel abnormally strong resistance when you press down on the plunger. These conditions can result in not delivering enough insulin. Warning: Do NOT inject air into the fill port. Doing so may result in unintended or interrupted insulin delivery. Warning: Do NOT fill the Reservoir Patch when you are wearing it. Doing so may cause serious harm to your life and health. 12. Hold the plunger in position while you remove the needle from the reservoir. Place the protective cap back on the needle. Safely dispose of the syringe in a waste container according to local waste disposal regulations. Warning: Use your Reservoir Patch right after you fill it. Do NOT store a Reservoir Patch filled with insulin. 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 Reservoir Patch has been filled and shall be used, the PDM will beep and/or vibrate every 10 minutes. If you do not apply the Reservoir Patch on your body within 3 hours, you must deactivate and discard it. Note: Once a Reservoir Patch (connected with a Pump Base) is activated and communicates with a PDM, it can only receive commands from that PDM, not from any other. 4.1.5 Prime the Pump Once the Reservoir Patch is filled with an appropriate amount of insulin (70 U-
200 U), tap Next on your PDM and you will see the following message on the screen. 82 B ureau Veritas Hold the Patch Pump on a clean flat surface with one hand, and with the other hand, press the top square part 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. 83 B ureau Veritas 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. Warning: If the Pump fails to vibrate, call customer support. To continue using 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 subcutaneous fat. 84 B ureau Veritas
The area stays flat during normal daily activities without bending or creasing. When choosing the location for the Pump, avoid the following:
Areas that are constrained by clothing, such as the belt line or waist. Curved or rigid areas due to muscle or bone. Areas that involve rigorous movement during exercise. Areas of skin with scars, tattoos, or irritation. 5.0 cm (2 inches) around the navel. Areas with excess hair. Body areas (shaded) suitable for infusion sites:
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 least 2.5 cm (1 inch) away from the last site. Practice using an aseptic technique as described at the beginning of this chapter. Clean the area with an alcohol wipe where you will attach the Pump. Let the area dry before applying the Pump. 85 B ureau Veritas Note: If you have sensitive skin or your skin gets irritated, contact your healthcare provider. 4.1.7 Attach the Patch Pump 1. Remove the button cover. 2. Peel off the adhesive liner 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. 86 B ureau Veritas 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. 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 appears. 87 B ureau Veritas Warning: Check the infusion site and needle after insertion to ensure that the needle has been properly inserted. If the needle is not properly inserted, hyperglycemia may ensue. 3. 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. 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 the Reservoir Patch while the Patch Pump is connected to your body. 88 B ureau Veritas Warning: Check the infusion site frequently for improper placement and leaks that can result in inadequate infusion. You can also check blood glucose level to ensure normal infusion. 4.2 Bolus A bolus dose is insulin you deliver to cover meals or snacks, or to correct high blood glucose. Consult your healthcare provider about how to set your bolus dose. Your A7+ 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. Go to the Bolus screen. Main MenuBolus Note: When the Bolus Calculator is switched off in the Settings, Bolus Calculator will not appear in the Bolus menu. See Chapter Advanced Pump Features for more information. 4.2.1 Normal Bolus 1. To deliver a Normal Bolus, go to the Manual Bolus screen. Main MenuBolusManual Bolus 89 B ureau Veritas 2. 3. Set your bolus amount. 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. 90 B ureau Veritas 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 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 Home Screen. 91 B ureau Veritas 6. You can cancel an active Normal Bolus in the Suspend Menu even after insulin delivery has started. 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:
92 B ureau Veritas 8. If the total Bolus in the last 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. 93 B ureau Veritas 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. 4.2.2 Max Bolus The maximum bolus (Max Bolus) is a safety feature that limits the amount of insulin to be delivered in a single bolus. The factory setting is 10 units. You can set the limit from 0 to 30 units. Please set the maximum bolus with the help of your diabetes team. Go to the Max Bolus screen to set the max bolus. Main Menu SettingsInsulin PumpBolus SetupMax Bolus 4.3 Basal Basal rate is the rate at which your Patch Pump infuses small doses of insulin to cover your bodys 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 one basal rate for a 24-hour period. A selected basal pattern is exercised daily. You can set up to 48 basal rates for any basal pattern. See Select a Basal Pattern, Temp Basal, Preset Temp Basal in Chapter Advanced Pump Features for more information. 94 B ureau Veritas 4.3.1 Your Basal Settings You must program your basal settings before you deliver any basal insulin. Keep a written record of your basal settings. You can program up to 8 basal patterns with the A7+ TouchCare System. Having more than one pre-set basal pattern makes it easy for you to switch between patterns to cater to your different needs such as weekends, weekdays, shift work, 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 that you set your basal rates with the assistance of your healthcare provider. Go to the Basal Setup screen. Main MenuSettingsInsulin PumpBasal Setup 95 B ureau Veritas 4.3.2 Edit Your Standard Basal Pattern We recommend that you get acquainted with the Standard basal pattern before using multiple basal patterns. You can set up to 48 basal segments in the Standard basal pattern. Go to the Edit Basal screen. Main MenuSettingsInsulin PumpBasal SetupEdit 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 pattern cannot be edited. 96 B ureau Veritas 2. The edit screen appears. Tap +Add time segment to add a new segment. Enter the end time for this segment. Then tap Done. 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. 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 to the previous menu. 97 B ureau Veritas 24 Hour Total Note: If all 48 basal segments were added, the +Add time segment button disappears 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. StatusBasal 98 B ureau Veritas 4.3.4 Review Your Basal Patterns The Basal Review screen shows your daily basal rates of all patterns. 1. Go to the Basal Review screen. Main MenuSettingsInsulin PumpBasal SetupBasal Review 2. Choose the basal pattern that you want to review. Tap it to review your programmed settings. 99 B ureau Veritas 4.3.5 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. 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 00:00 (12:00AM). 100 B ureau Veritas 4.3.6 Change the time of the Basal Pattern Note: Only the ending time of a segment is editable. 1. Change the ending time point of a segment to a later time point. 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 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 editing. Example: the ending time point of the first segment is changed from 12:00 to 15:00, see following:
101 B ureau Veritas 2. Change the ending time point of a segment to an earlier time point When the ending time point B of a segment is changed to an earlier time point A, 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 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 is changed from 15:00 to 12:00. 102 B ureau Veritas 4.3.7 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. 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 MenuSettingsInsulin PumpBasal SetupMax Basal 2. You can modify max basal rate by using the number keyboard. 103 B ureau Veritas 4.4 Suspend and Resume 4.4.1 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. a. When no bolus is being delivered:
1. Go to the Suspend screen. Set a suspension time and tap Next to continue. Main MenuSuspend 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 you want to suspend insulin delivery. 104 B ureau Veritas Note: When you suspend insulin delivery, 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. 105 B ureau Veritas b. When a Normal/Extended/Combo Bolus is being delivered. 1. You can choose to suspend all insulin delivery or only the bolus. Main MenuSuspend If you select All, the same to the situation when no bolus is being delivered. The feature can stop all insulin. 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. 106 2. 3. B ureau Veritas Stop Normal Bolus 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. 107 B ureau Veritas Note: Only basal pattern can be resumed, Bolus and Temp Basal cannot be resumed. 4.5 Insulin Pump Settings Go to Insulin Pump Settings screen. You can turn on or off Insulin Pump, set Pump SN, set Bolus Setup, set 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. 108 B ureau Veritas Tap Pump Base SN to edit it. You can use your PDM to search for your Pump Base (only for the first time), or you can enter the SN printed on your Pump Base manually. The Pump Base SN can only be changed when there is no activated Reservoir Patch. See Section Activate a New Reservoir Patch for more information. 4.5.2 Bolus Setup Tap Bolus Setup on the Insulin Pump screen to enter the Bolus Setup screen. You can set Bolus Calculator, Preset Bolus 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 that limits the amount of insulin that can be delivered in a single bolus. The factory setting is 10 units. You can set the limit between 0 and 30 units. Please set the maximum bolus with the help of your healthcare provider. 109 B ureau Veritas 4.5.3 Basal Setup Tap Basal Setup on the Insulin Pump screen to enter the Basal Setup screen. You can edit basal, check basal review, set preset temp basal and set Max basal. 1. Edit Basal See Section Basal in Chapter How to use Patch Pump 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 Patch Pump for more information. The Basal Review screen shows your daily basal rates of all patterns. 3. Preset Temp Basal See Section Preset 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 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. Please set the maximum basal rate with the help of your healthcare provider. The factory default is 2.0 U/H. 110 B ureau Veritas 4.5.4 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 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 select one of these warning types:
111 B ureau Veritas A specified number of units that remain in the Reservoir Patch A specified maximum amount of time that remains before the Reservoir Patch will be empty Note: You can set the amount of insulin between 5 U and 50 U with an increment of 1 U. You can set the time between 2h and 24h with an increment of 30 min. Note: If a bolus is being delivered when a LOW RESERVOIR Alert occurs, your remaining insulin may be less than the value on the alert screen. 3. Max Delivery This program is designed to instruct the Pump to automatically suspend insulin delivery and give 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 your healthcare provider. Note: You can set the Daily Max between 20 and 180 U and the Hourly Max between 10 and 40U. 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. 112 B ureau Veritas 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. 4. Auto Off You may program your PDM to automatically suspend basal delivery and give an alarm if the PDM does not receive a Patch 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 are best for you with your healthcare provider. Note: You can set the time between 1h and 24h with an increment of 1h. 113 B ureau Veritas 114 B ureau Veritas 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. Consult your healthcare provider for your personal I:C ratios, Insulin Sensitivity Factor (ISF), BG Target ranges and IOB Time. 5.1.1 How the Bolus Calculator Works Enter your BG reading as a calculation factor of Bolus Calculator. If you are going to eat a meal, enter your food amount in carbs. The bolus calculator will 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 calculator feature on the Bolus Calc Setup screen or when PDM is turned on for the first time. Instructions for programming the bolus calculator feature settings are in the following paragraphs. Program your settings in the order as describe in the following to make sure you have programmed all the settings. Bolus Calculator Feature on/off 1. Go to the Bolus Calc Setup screen. Main MenuSettings Insulin PumpBolus SetupBolus Calc Setup 115 B ureau Veritas 2. 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. 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, select IC Ratios. 116 B ureau Veritas 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. When the carbs is between 10 g and 200 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. Tap Delete to delete the selected segment. The first segment cannot be deleted. 117 B ureau Veritas 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. Because this amount may vary throughout the day, you can set up to eight different time slots. Your healthcare provider may only have you program one or two insulin sensitivity factors 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) with an increment of 0.1 mmol/L (1 mg/dL). 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. 118 B ureau Veritas 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. 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 save settings. Or Press to cancel setup and exit the edit mode. 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. 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 your food bolus. On the Bolus Calc Setup screen, select BG Target. 1The first segment always starts at midnight. The BG Range field is indicated by the blue editable digit. Note: You can set the low and high limit between 3.3 mmol/L and 13.9 mmol/L
(60 mg/dL and 250 mg/dL) with an increment of 0.1 mmol/L (1 mg/dL). The high limit should never be lower than the low limit. 119 B ureau Veritas 2Tap + 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. 3Continue 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. 4When finished, press to exit the edit mode and press to save settings. IOB Time 120 B ureau Veritas The IOB feature shows how much insulin from a previous bolus dose might still be active in your body. The actual amount of insulin left in your body is determined by the rate at which your body utilizes insulin, your infusion site, your activity level, and other factors. Your PDM uses a curvilinear algorithm that mimics the way insulin is metabolized to track IOB. The IOB setting lets the PDM know which IOB to use in calculating the 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 can calculate an estimate of insulin you need for your correction bolus or food bolus. You have the option of using the estimated dose or changing it as necessary. 1. In the Bolus screen, select Bolus Calculator. 121 B ureau Veritas 2. Tap BG value to enter your BG and tap Carbs value to enter your carbohydrate amount. 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). 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 of 0.05 U. 122 B ureau Veritas 3. After BG and Carbs input, the recommended Bolus dose according to the Bolus Calculator appears on the right side of the BG value and carbohydrate amount. For example:
4. 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. 123 B ureau Veritas See BG Reminder in this chapter for more information. 5. Slide to Deliver to begin the bolus delivery. 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: 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. It is also useful if you will be eating (grazing) over a few hours or if you have gastroparesis, which means food remains in the stomach for a longer period than it normally does. 124 B ureau Veritas See the following graphic for a description of the different bolus types. 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 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 Bolus. 125 B ureau Veritas b. c. Tap Type option to choose Extended Bolus. Then tap Next. 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. d. 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. 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 Bolus units and tap Next. 126 B ureau Veritas 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. b. Tap Type option to choose Combo Bolus. Then tap Next. c. Tap the blue icon to increase Normal Bolus. 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 Reminder in this chapter for more information. 127 B ureau Veritas e. Details of the Combo Bolus will be displayed. Slide to Deliver to start delivery. 5.2.2 Combo/Extended Bolus Using Bolus Calculator If you are using the bolus calculator feature to calculate your extended or Combo Bolus amounts, you will be prompted to enter your BG reading and/or 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 calculated bolus amount appears in the right. Tap Next to continue. 128 B ureau Veritas Note: If you need to make any changes in the previous menu, press to return to the previous menu, select Bolus Calculator, and re-enter the values. 3. 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. 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 appears. Enter the amount of time you want the Extended Bolus to last and tap Next. 129 B ureau Veritas Note: You can set the duration between 30 min and 8 h with an increment of 30 min. b. 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. See BG Reminder in this chapter for more information. Combo Bolus To set a Combo Bolus, follow these steps:
Tap the blue icon to increase Normal Bolus. Tap the purple icon a. to increase Extended part. b. Enter the amount of time you want the Extended Bolus to last and tap Next to continue. 130 B ureau Veritas Note: You can set the duration between 30 min and 8 h 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 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. 131 B ureau Veritas 5.3.1 Preset Bolus Setup 1. Go to the Preset Bolus Setup screen. Main MenuSettingsInsulin PumpBolus SetupPreset Bolus 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. 132 B ureau Veritas 4. Tap Save to save the settings. Tap or Home button and tap No to quit the settings. 5.3.2 Deliver a Preset Bolus You must set up a preset bolus before you can deliver it. 1. Go to the Preset Bolus screen. Main MenuBolusPreset 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. 133 B ureau Veritas 3. Verify your preset bolus settings. 4. Start bolus delivery. 5.4 Select a Basal Pattern 1. Go to the Select Pattern screen. Main MenuBasalSelect Pattern 2. Select the desired pattern to activate. 5.5 Temp Basal With a temp basal rate, you can adjust your basal rate for a short period of time to manage glucose levels during temporary 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 selected basal pattern. 5.5.1 Activate a Temp Basal 1. Go to the Temp Basal screen. Main MenuBasalTemp Basal 134 B ureau Veritas
1 | User Manual-2 | Users Manual | 2.27 MiB | February 20 2020 |
2. Select a temp basal type, temp rate or percent and duration, then Tap Next to review the temporary basal rates set. Note: If Percent is selected, you can set the temp basal rate, not exceeding the Max Basal Rate, between 0 and 200% with an increment of 1%. If Rate (U/H) is selected, you can set the temp basal between 0 and the Max Basal Rate with an increment of 0.05 U/H. Note: You can set the duration between 30 min and 24h with an increment of 30 min. 3. Make sure that the temp basal is correct in this Temp Basal Review, then Slide to activate. 5.5.2 Cancel a Temp Basal 1. Go to the Cancel Temp Basal screen. Select Cancel Temp Basal. 135 B ureau Veritas Main MenuBasalCancel Temp Basal 2. 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. 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 seven preset temp basal rates:
Heavy Ex, Medium Ex, Light Ex, Sick, Temp 1, and Temp 2 and Temp 3. 5.6.1 Preset Temp Basal Setup 1. Go to the Preset Temp Setup screen. 136 B ureau Veritas 2. 3. Main MenuSettingsInsulin PumpBasal SetupPreset Temp Setup Select a preset temp basal you want to edit. Choose the temp basal type
(rate or percent). 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. 1. Go to the Preset Temp Basal screen. Main MenuBasalPreset Temp Basal The programmed preset temp basal types are displayed on this screen. If you have not set up any preset temp basal rate, this screen shows No Presets. Select the preset temp basal you want to activate. 137 2. B ureau Veritas 3. 4. Confirm your preset temp basal settings. Slide to activate. 5.7 Reminder 5.7.1 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. 1 1. Time Point A 2. Time Point B 2 You can add, delete, or review Reminders when the Bolus Reminder option is turned on. Go to the Bolus Reminder screen. Main MenuSettingsReminders Bolus Reminder Add Reminder Tap + Add time segment to add one Reminder, setting the start and end time. 138 B ureau Veritas 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. 5.7.2 BG Reminder After you deliver a bolus, you may want to check your BG. The BG Reminder is an optional feature that reminds you to check your BG after a bolus. Go to the BG Reminder Setup screen. Main Menu SettingsRemindersBG Reminder 139 B ureau Veritas 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. The default time is 00:30. You can also turn off the BG reminder after each bolus. You can accept or modify the time before you are reminded. 5.8 Pump History 5.8.1 Pump History The Pump History displays the delivery history (bolus, basal and total daily 140 B ureau Veritas delivery history) and alert history (pump alerts and alarms). Go to the Pump History screen. Main MenuHistoryPump History 5.8.1.1 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. 1. Tap the date to switch between records of different dates 2. Tap the review legend meanings. info icon to 3. Tap the Basal, Bolus, Total summary chart at the bottom of Delivery History screen to see details.
(1) The legend 141 B ureau Veritas Legend Abbreviation Significance Basal Temp Basal Normal Bolus Extended Bolus Auto Suspend Manual Suspend Stop New Patch Basal Rate infusion curve Temp Basal Rate infusion curve Normal Bolus delivery icon LOW Extended Bolus delivery icon This tag appears when any of the following alarms occurs:
AUTO OFF, PREDICTIVE LOW SUSPEND, SUSPEND, EXCEEDS MAX TDD, EXCEEDS MAX 1HR DELIVERY ALARM. Manually suspend all insulin delivery Including deactivate patch, discard patch, and alarms:
OCCLUSION DETECTED, PATCH EXPIRED, PATCH ERROR, PATCH BATT DEPLETED, PUMP BASE ERROR, EMPTY RESERVOIR. When you activate a new patch, this icon appears.
(2) Basal History This screen displays most detailed Basal information. 142 B ureau Veritas
(3) Bolus history The summary information includes:
Status of bolus: completed, canceled, delivering;
The start time of this bolus;
Bolus type;
Amount of bolus delivered |Amount of bolus programmed. Bolus Type:
N: Normal Bolus E: Extended Bolus C: Combo Bolus Normal: Normal Bolus by Manual Bolus Extended: Extended Bolus by Manual Bolus 143 B ureau Veritas Combo: Combo Bolus by Manual Bolus Calc-N: Normal Bolus by Bolus Calculator Calc-E: Extended Bolus by Bolus Calculator Calc-C: Combo Bolus by Bolus Calculator Tap record line to view more detailed information. See Chapter Advanced Pump Features for more information.
(4) Daily Totals This screen displays most detailed Daily Totals information. 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. Food+Corr 0.00U #0 means that there is no bolus dose that both covers carbs and corrects glucose in the selected day. ManualBo 9.70U #2 means that there are two manual bolus doses in the selected day with a total amount of 9.70U. 144 B ureau Veritas 5.8.1.2 Alert History Go to the pump Alert History screen. Main MenuHistoryPump HistoryAlert 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 Section Alert Icons in Chapter How to us the PDM for more information about how to address alarms and alerts and the meanings of different alarm/alert icons. 5.8.2 Pump Summary History 5.8.2.1 Summary History: Insulin History This screen displays the insulin delivery summary history. Go to the Insulin History screen. Main MenuHistorySummary History Insulin History 145 B ureau Veritas Daily Insulin: Total daily dose of insulin delivered per day. Daily Basal: Average daily dose and percentage of insulin delivered as Basal. Daily Bolus: Average daily dose and percentage of insulin delivered as Bolus. Daily Carbs: Average daily amount of carbs. 5.8.2.2 Summary History: Bolus History This screen displays the Bolus summary history. Main MenuHistorySummary History Bolus History Carbs Bolus Only: Average daily dose and the number of times of Food Bolus only on the selected days. BG Correction Only: Average daily dose and the number of times of BG correction Bolus only on the selected days. 5.9 Troubleshooting Pump issues Can I take a sauna with a Patch Pump on?
No. Firstly, the operating temperature range for the Patch Pumps is +5C ~ +40C. Secondly, if you take a sauna, insulin will be absorbed faster into your body, and your blood glucose can fluctuate. Can I dive with a Patch Pump on?
No. 146 B ureau Veritas Your Patch Pump is waterproof to a depth of 2.5 meters (8 feet) for up to 60 minutes (IPX8). It means the maximum pressure the device can tolerate equals the pressure in 2.5m deep in STILL water instead of flowing water. It is OK to take a shower or go swimming with the devices on, but if you go diving, the water pressure may be too high for the devices. I didnt see an alert message, but it appeared in History. 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. Alert change After insulin delivery automatically starts again, alert is switched to BASAL RESUMED. EXCEEDS MAX 1HR DELIVERY After insulin delivery automatically starts again, alert is switched to BASAL RESUMED. Alert EXCEEDS MAX TDD 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 alert may have escalated to another alert/alarm, and you will ONLY see the message of the escalated alert/alarm. The first alert will appear in History. Alert LOW RESERVOIR PATCH EXP ADVISORY AUTO OFF ALERT Alert escalation EMPTY RESERVOIR PATCH EXP IN 1 HOUR, then PATCH EXPIRED AUTO OFF Lights on the Patch Pump Once you connect the pump base with a new Reservoir Patch, you will see the indicator light flashing in the order of blue, green, yellow, and red. When you are activating the new patch, you will see the green light flashing until the basal pattern is activated. A yellow (orange) light indicates an alert, while a red light indicates an alarm. 147 B ureau Veritas If the PDM is away from the Patch Pump, how will the basal rate be delivered?
The selected basal pattern is stored in the pump base, which means that even if the PDM is away, the basal pattern will continue as planned. Can I fill the patch with insulin when the patch is on body?
NO. NEVER DO THAT. Insulin can go directly into your body, which is very dangerous. No magnetic objects around when activating (priming) 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, tablets, other Reservoir Patches, TVs, refrigerators, and sound options. The Patch Pump will detect the volume of insulin in the reservoir once it is filled, and if the Patch Pump is in a magnetic field, the volume detected can be inaccurate. 148 B ureau Veritas 149 B ureau Veritas 150 B ureau Veritas 6 How to use CGM system (Optional) 6.1 Glucose Alerts Set your Low and High glucose alerts before using the sensor. See Section Glucose Alerts in Chapter How to use (P)LGS for more information. 6.2 Change Sensor Your Sensor gives glucose readings for up to 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. 6.2.1 Disconnect Sensor from Your PDM Go to Disconnect Sensor screen. Main MenuSensorDisconnect Sensor Note: The Disconnect Sensor option is only available when a Sensor is currently connected to the PDM. 151 B ureau Veritas 6.2.2 Remove the Current Sensor and Disconnect the Transmitter 1. Gently peel the adhesive pad off your skin in one continuous movement to remove the Sensor and Transmitter. 2. Pinch the ribbed release tabs on the sides of the Sensor support mount, and gently pull the Transmitter away from the Sensor support mount. 3. 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. Do NOT store the Transmitter connecting a Sensor or a USB charging cable on which may kill the Transmitter battery. 6.2.3 Charge the Transmitter The Transmitter is charged via a USB charging cable which is plugged into a USB 2.0/3.0 port or a power adapter with a rated voltage of DC 5V and a rated current higher than DC 1000mA. The device with the USB port and the power adapter must comply with EN 60950-1 or EN 60601-1. 152 B ureau Veritas The battery must be fully charged the first time you use the Transmitter, which may take up to 2 hours. It is recommended to recharge the Transmitter after each Sensor session. If a Transmitter is stored for two months, you must fully charge the Transmitter battery to ensure it works properly. 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. 6.2.4 Add the Transmitter SN Any time when you switch to a new Transmitter and/or a PDM you must add the Transmitter SN. Main MenuSensorTransmitter SN 1. Tap Connect Sensor if you have set the Transmitter SN. Note: Dont forget to update the SN if you change to a new Transmitter. Note: You can only change the Transmitter SN when there is no Sensor connected. You can find the Transmitter SN on the product box or on the back of the Transmitter. 153 B ureau Veritas 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. 154 B ureau Veritas 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. See Section Insert a New Sensor for more information. If you tap Search in Sensor, you will see the following message when you search for the SN. 155 B ureau Veritas 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 --------- to enter the SN manually. 156 B ureau Veritas 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. 6.2.5 Insert a New Sensor 6.2.5.1 Select an Insertion Site When choosing the location for the Sensor, consider the following:
That you can comfortably reach the Sensor. That you apply the Sensor to a flat area of skin with adequate subcutaneous fat. That the area stays flat during normal daily activities without bending or creasing. When choosing the location for the Sensor, avoid the following:
Within 7.5 cm (3 inches) of an insulin pump infusion site or manual Areas that are constrained by clothing, such as the belt line or waist. Curved or rigid areas due to muscle or bone. Areas that involve rigorous movement during exercise. Areas of skin with scars, tattoos, or irritation. 5.0 cm (2 inches) around the navel. Areas with excess hair. injection site. Shown here are the best body areas (shaded) for Sensor insertion. 157 B ureau Veritas 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. 6.2.5.2 Prepare the Insertion Site 1. Wash your hands thoroughly with soap and water and wait for them dry up. 2. Wipe the selected insertion area with rubbing alcohol and wait for the area to dry up. This may help prevent infection. Do NOT insert the Sensor until the cleaned area is dry. This will make the Sensor adhesive stay on the skin more firmly. Warning: If the Sensor dislodges because the Sensor support adhesive fails to adhere to the skin, you may get false or no readings. Improper site selection and improper site preparation may result in poor adhesion. 6.2.5.3 Unpack the Glucose Sensor Open the Sensor package by peeling off the paper on the back of the package. Pay attention to the following:
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. After opening the package, avoid touching any Sensor surface that will be in contact with the body, i.e., adhesive 158 B ureau Veritas surface. You may contaminate the insertion site and suffer an infection if you have unclean hands while inserting the Sensor. 6.2.5.4 Remove the Protective Liner from the Sensor Support Mount Bend the two-piece protective liner slightly on the edge so you can see the seam between the two pieces. Hold the inserter part of the Sensor, and try not to touch the adhesive surface. Remove the liners from the Sensor support mount one after another. 6.2.5.5 Locate the Sensor Support Mount If you are inserting the Sensor on your abdomen or lower back, place the Sensor horizontally on your skin. If you are inserting the Sensor on your upper arm or thigh, place the Sensor vertically on your skin. Move your fingers around the adhesive pad to secure it to your skin. 6.2.5.6 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. 159 B ureau Veritas 6.2.5.7 Insert the Sensor Hold the inserter as shown below and press the two buttons at the same time. You might feel a slight pinch as the Sensor is placed just under your skin. 6.2.5.8 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. Only the Sensor support mount will be left on your body. 160 B ureau Veritas 6.2.5.9 Check the Sensor Support Mount Confirm that the Sensor support mount remains tightly adhered to your skin by sliding your finger along the edges of the adhesive pad and examine for any gaps in adhesion. Warning: If bleeding occurs at the insertion site, do not attach the Transmitter to the Sensor. Apply steady pressure using a sterile gauze or clean cloth for up to 3 minutes. If bleeding stops, attach the Transmitter to the Sensor. If bleeding continues, remove the Sensor, treat the site as necessary, and insert a new Sensor at a different site. Warning: Check the insertion site frequently for infection or inflammation redness, swelling or pain. Remove the Sensor and seek professional medical help if one of these conditions occurs. 6.2.5.10 Discard the Sensor Inserter Safely Attach the safety lock on the inserter to cover its opening and conceal the needle inside. Follow local waste disposal regulations when discarding the inserter. We recommend discarding the Sensor inserter into a sharps container or a puncture-proof container with a tight lid. 6.2.6 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. Before attaching the Transmitter to the Sensor, you must have the Transmitter battery fully charged and the PDM set up. Snap the Transmitter into the Sensor support mount until the two flexible arms fit into the notches on the Transmitter. The indicator light will flash green after 161 B ureau Veritas successful connection, three times after properly connected and another six times after successful system check. Note: Make sure that you hear a click when you snap the Transmitter in place. If it is not fully snapped in, electrical connection and waterproof can be compromised, which can lead to inaccurate Sensor glucose readings. Tape the Sensor Support Mount (Optional) 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. Do NOT tape over the Transmitter or any of the plastic parts on the Sensor support mount. 6.2.7 Connect Sensor to Your PDM 1. Go to Connect Sensor screen. Main MenuSensorConnect Sensor 162 B ureau Veritas Note: The Connect Sensor option is only available when no Sensor is currently connected to the PDM. 2. Make sure that your Transmitter is connected to a Sensor and that your Transmitter SN is found or entered, and then continue by tapping Next. 3. If the sensor is calibration-free, enter the sensor code on the sensor label which is unique for each sensor. Once the sensor code is entered successfully, the calibrations arent required. Or, skip the sensor code input step and go to Connection screen. The sensor need to be calibrated twice (once every 12 hours) on the first day and then once every 24 hours since the second day. 4. When finished, the following screen appears. 163 B ureau Veritas Note:
If you want to remove a Sensor before its expiration, disconnect it from your PDM first before you connect a new Sensor. When you connect a new Sensor directly, a SENSOR RECONNECTED message will appear on your PDM. 6.3 Calibrate Your Sensor Each time the PDM prompts you with the message METER BG NOW or SENSOR CAL REMINDER, you must enter a BG measurement to calibrate your Sensor. Go to the Sensor Calibration screen. Main MenuSensorSensor Calibration 164 B ureau Veritas Note: If your sensor is not a calibration-free sensor, or you skip the sensor code input step, you must calibrate your sensor at least twice (once every 12 hours) on the first day and then once every 24 hours since the second day. If you have entered sensor code successfully, the system wont require calibration. But you can calibrate the sensor if you want. Sensor disconnected from the PDM Sensor warm-up Note: Calibration is unavailable under the following circumstances:
Within 15 min after the alert SENSOR CAL ERROR No Readings Poor RF communication between the Transmitter and the PDM 6.3.1 Enter Your Meter BG Here you can enter your present blood glucose measured by a finger prick blood glucose meter. 1. Go to the Enter BG screen. Main MenuSensorSensor Calibration 165 B ureau Veritas Note: Please enter the exact blood glucose value of a carefully performed fingerstick displayed on your blood glucose meter within five minutes. 2. Tap Done to confirm your fingerstick, then tap Yes button to start calibration. 3. When finished, the following screen appears. 166 B ureau Veritas 6.3.2 Set Calibration Repeat Go to the Cal Repeat screen. Main MenuSettingsCGM SystemCal 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 turn Cal Repeat on/off. If Cal Repeat is on, you can set the repeat time of METER BG NOW alert from 5 min to 1h with an increment of 5 min. 6.3.3 Calibration Reminder Calibration reminder enables you to get reminded a certain time before the due time of next calibration. 1. Go to the Cal Reminder screen. 167 B ureau Veritas Main MenuSettingsReminders Cal Reminder 2. 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. 6.4 CGM System settings Go to the CGM System screen. Main MenuSettingsCGM System 6.4.1 CGM Feature on/off The CGM feature must be turned on to receive Sensor data. 1. Select CGM System in the Settings menu. Main MenuSettingsCGM System 168 B ureau Veritas 2. You can turn on or off the CGM feature. 3. After you turn on the CGM System, the Transmitter SN menu appears. 6.4.2 Set the 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. You can also enter your new Transmitter SN in CGM System menu. See Add the Transmitter SN for more information. 169 B ureau Veritas 6.4.3 Graph Range You can set the time range of sensor graph in horizontal screen as 3, 6, 12, 24 hours. The default range is 12 hours. 6.4.4 Cal Repeat See Section Calibrate Your Sensor in this chapter for more information. 6.4.5 Alert Silence Go to the Alert Silence screen. Main MenuSettingsCGM SystemAlert Silence Warning: Muting the alarms is not recommended when you are unable to interact with your PDM (for instance, when you are asleep). 170 B ureau Veritas Interacting with your PDM includes activities such as pressing the power button and checking the screen. With the Alert Silence feature you can keep glucose alerts silent for a specified time of 30 minutes to 24 hours. There are five Alert Silence options:
Off This means all glucose alerts are turned on: the PDM will beep or vibrate if any Sensor alert occurs. Low The PDM will not beep or vibrate if a low alert (LOW GLUCOSE, RAPID FALL or LOW PREDICTED) occurs during the specified time. High The PDM will not beep or vibrate if a high alert (HIGH GLUCOSE, RAPID RISE or HIGH PREDICTED) occurs during the specified time. High and Low The PDM will not beep or vibrate if a high/low alert
(HIGH/LOW GLUCOSE, RAPID RISE/FALL, HIGH/LOW PREDICTED) occurs during the specified time. 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 and Chapter Safety System and Alarms/Alerts for more information. 6.4.6 Sensor Expired Go to the Sensor Expired screen. Main MenuSettingsCGM SystemSensor Expired 171 B ureau Veritas For MD1026, the expiration date is fixed as 14 days. In both settings, SENSOR EXP IN 6 HOURS alert, SENSOR EXP IN 2 HOURS alert, SENSOR EXP IN 30 MIN and SENSOR EXPIRED alert will respectively appear. 6.5 Sensor History 6.5.1 Sensor History Your PDM stores detailed Sensor history to help you keep track of your glucose readings and Sensor conditions. Go to the Sensor History screen. Main MenuHistorySensor History 6.5.1.1 Data History 1. 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. 172 B ureau Veritas 2. Select a Sensor session and you will see the last days Sensor history data. The Y-axis of the Sensor graph is featured by four values: 5, 10, 15, 20 mmol/L
(90, 180, 270, 360 mg/dL). The X-axis of the Sensor graph presents a period of 24 hours. The Sensor graph can be switched to a landscape screen display. Long tap the Sensor graph for 1 second and the display will turn horizontal. 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
. Readings during warm-up phase will not be displayed but marked as warm-up. 173 B ureau Veritas Glucose value or special status will always be shown in the area below, between the left and right arrow button. Special status includes: calibration error (ERR), no readings (???), warm-up phase (Warm-up), Sensor glucose is above 22.2 mmol/L or 400mg/dL (HIGH) and Sensor glucose is below 2.2 mmol/L or 40mg/dL (LOW). After the warm-up phase, the values before the first calibration are marked as BG. When the Sensor calibration expires, the reading values will be underlined. Calibration will be marked with a red dot . In the landscape screen display, tap the Home Key to return to the Home Screen. In the following situations, you cannot enter landscape screen by long-
pressing the graph when no Sensor is connected. when the data is being recovered after reconnection. 3. Tap the date and you will see a list of dates within that session. 4. Select a date and you will see the 24-hour Sensor trend graph of that day. 6.5.1.2 Calibration History Select Calibration History in the Sensor History screen. The Calibration History screen displays the calibration history. 174 B ureau Veritas 6.5.1.3 Alert History Select Alert History in the Sensor History screen. The Alert History screen shows you all of the Sensor alerts that have recently occurred. Select an alert record to view the details. Tap to return to the previous menu. See Section Alert Icons and Chapter Safety System and Alarms/Alerts for more information about how to address the alarms and alerts. 6.5.2 Summary History: Sensor History This screen displays the SG readings summary history. Go to Sensor History screen. Main MenuHistorySummary HistorySensor History 175 B ureau Veritas Average SG: Average SG readings of the selected days. Time in target range: The percentage of the duration in which SG reading is in the target range (3.9 - 10.0 mmol/L or 70 - 180 mg/dL). Time above range: The percentage of the duration in which SG reading is above the target range (10.0 mmol/L or 180 mg/dL). Time below range: The percentage of the duration in which SG reading is below the target range (3.9 mmol/L or 70 mg/dL). 6.6 Troubleshooting CGM issues Can I take a sauna with the CGM System on?
No. Firstly, the operating temperature range for the Transmitter is +5C ~ +40C. Secondly, if you take a sauna, your blood glucose can fluctuate. Can I dive with a Sensor on?
No. Your Sensor (including the installed Transmitter) is waterproof to a depth of 2.5 meters (8 feet) for up to 60 minutes (IPX8). It means the maximum pressure the device can tolerate equals the pressure in 2.5m deep in STILL water instead of flowing water. It is OK to take a shower or go swimming with the devices on, but if you go diving, the water pressure may be too high for the devices. 176 B ureau Veritas I didnt see an alert message, but it appeared in History. 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. 1. LOW GLUCOSE 2. HIGH GLUCOSE 3. LOW PREDICTED 4. HIGH PREDICTED 5. RAPID RISE 6. RAPID FALL 7. ALERT SILENCE 8. SENSOR ERROR 9. BELOW 3.1 mmol/L (56 mg/dL) 10. LOST SENSOR If the following alert happened, the PDM would beep/vibrate and display a message first, and if you missed that alert, later when you checked the PDM, the alert may have escalated to another alert/alarm, and you will ONLY see the message of the escalated alert/alarm. The first alert will appear in History. Alert SENSOR EXP IN 6 HOURS Alert Escalation SENSOR EXP IN 2 HOURS, then SENSOR EXP IN 30 MIN, at last SENSOR EXPIRED 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 system check has completed. 177 B ureau Veritas Some Sensor readings missing on the Sensor Trend Screen is too far away from the Transmitter, or the Bluetooth If the PDM communication between the Transmitter and the PDM is temporarily interrupted, some Sensor readings might be missing in the Sensor Trend Graph screen. Solution: Move the PDM close to the Transmitter, and wait for a while. The data will be recovered automatically. What to do when a Lost Sensor alert happens Move the PDM closer. If the PDM cannot connect with the Transmitter in 10 minutes, keep the Sensor in, disconnect the Sensor from the PDM menu, and connect again. 178 B ureau Veritas 179 B ureau Veritas 180 B ureau Veritas 7 How to use (P)LGS (Optional) 7.1 (P)LGS settings The Glucose Alerts 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. Tap EasyLoop on the Home Menu Screen to enter the EasyLoop screen. 7.1.1 Glucose Alerts When the glucose alerts feature is turned on, the system can send you glucose alerts including High/Low Glucose, High/Low Predicted and Rate Alerts. Main MenuEasyLoopGlucose Alerts 181 B ureau Veritas 1. You can turn on or off the Glucose Alerts. 2. Tap to save the settings. 7.1.1.1 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. Go to the Glucose Limits screen. Main menuEasyLoopGlucose AlertsGlucose Limits 182 B ureau Veritas 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. If you only set one segment, the glucose limits of this segment will be applied for 24 hours. You can set up to 8 segments with the Low and High limits for each during real-
time monitoring. 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 183 Note:
B ureau Veritas 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). The High Limit value is always larger than the Low Limit value. In the first segment, the default Low Limit is 4.4mmol/L, the default High Limit is 13.3mmol/L. 2. Delete Segments Slide from right to left on one segment, tap Delete to delete this segment. 3. Tap to save the settings. 7.1.1.2 Predictive Alerts The predictive alerts calculate when you are going to reach your Low or High Glucose Limits, and then send you an alert before you reach those limits. A predictive alert informs you that if your Sensor glucose keeps falling or rising at the current rate, you will reach your Glucose Limit in the number of minutes you set before. Go to the Predictive Alerts screen. Main menuEasyLoopGlucose Alerts Predictive Alerts 1. You can tap to turn on/off the Predictive Alerts 184 B ureau Veritas 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. 3. Tap to save the settings. 7.1.1.3 Rate Alerts There are two types of rate alerts:
Rapid Fall for Sensor glucose decreasing at or faster than your pre-selected rate Rapid Rise for Sensor glucose increasing at or faster than your pre-selected rate Go to the Rate Alerts screen. Main menuEasyLoopGlucose Alerts Rate Alerts 185 B ureau Veritas Go to the Rise screen. 1. You can tap to turn on/off the Rise Alerts. 2. You can choose a relative mild or an acute rising rate. See Section Sensor Status for more information. 186 B ureau Veritas 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. 4. Tap to save the settings. Go to the Fall screen. 1. You can tap to turn on/off the Fall Alerts. 2. You can choose a relative mild or an acute falling rate. See Section Sensor Status for more information. 187 B ureau Veritas 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). Tap the blue rate value to set the fall alert time. You will be reminded when your SG is falling rapidly. 3. Tap to save the settings. 7.1.1.4 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. 188 B ureau Veritas Note: You can turn on or off alert. Note: You can set the Repeat time between 5 min and 3h with an increment of 5 min. 7.1.2 (Pre) Low Suspend Go to the Low Suspend screen. Main menuEasyLoop(Pre) Low Suspend Note: If you turn the Low Suspend on, the Predictive Low Suspend feature will appear. 7.1.2.1 Low Suspend The Low Glucose Suspend feature is only available when both a Patch Pump and a Glucose Sensor are in use. The factory setting for this feature is off. If you turn it on, your PDM will automatically suspend insulin delivery and give an alarm 189 B ureau Veritas when your Sensor glucose is at or below the low suspend limit, and resume basal insulin when the risk of low glucose no longer exits. This feature can be used as a safe guard against excessive insulin delivery. You may choose to program this feature based on the lowest acceptable Sensor glucose. Discuss what settings are best for you with your healthcare provider. Note: The low suspend limit between 2.8 mmol/L and 5.0 mmol/L (50 mg/dL and 80 mg/dL) based on the Glucose Low Limit settings. See Section High/Low Limits for more information. Triggering Conditions for Low Suspend The Sensor glucose value is at or below the low suspend limit. 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. Triggering Conditions for Automatic Resumption of Basal (from 30 min to 2 h after suspension) Both of the following two conditions must be met for the system to resume basal insulin automatically. The Sensor glucose value is at least 0.8 mmol/L (15 mg/dL) higher than the low suspend limit. 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. Alarm Response If the Low Suspend alarm is not cleared within 10 minutes, a siren will sound with the following Reminder. 190 B ureau Veritas If the Low Suspend alarm is not cleared during suspension and insulin is resumed within 2 hours, the following Reminder will appear. 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. 191 B ureau Veritas If the Low Suspend alarm is cleared during suspension, a Reminder will appear when insulin is automatically resumed. For information on when the Low Suspend feature is unavailable, refer to Predictive Low Suspend. 7.1.2.2 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. If you turn it on, your PDM will automatically suspend insulin delivery and give an alarm when your Sensor glucose is predicted to reach the low suspend limit in a set period of time, and resume basal insulin when the risk of low glucose no longer exits. This feature can be used as a safeguard against excessive insulin delivery. Discuss what settings are best for you with your healthcare provider. Go to Pre Low Suspend screen. 192 B ureau Veritas Main MenuEasyLoop(Pre) Low Suspend 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. The Sensor glucose value is at or within 3.9 mmol/L (70 mg/dL) above the low suspend limit. The Sensor glucose value is predicted to fall at or within 0.8 mmol/L (15 mg/dL) above the low suspend limit in the set period of time and the rate of glucose change is negative. Time of Suspension Once Predictive 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. Triggering Conditions for Automatic Resumption of Basal Both of the following two conditions must be met for the system to resume basal insulin automatically. The Sensor glucose value is at least 0.8 mmol/L (15 mg/dL) higher than the low suspend limit. 193 B ureau Veritas 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. When the Low Suspend Feature and Predictive Low Suspend feature are Unavailable After insulin delivery is resumed from Low Suspend or Predictive Low Suspend, the Low Suspend feature and Predictive Low Suspend feature will be unavailable for 30 minutes. 7.2 Summary History: Low Suspend History Go to Low Suspend History screen. Main MenuHistorySummary HistoryLow Suspend History 194 B ureau Veritas This screen displays the (Pre) Low Suspend summary history.
# of LGS: Average daily number of Suspend due to LGS.
# of PLGS: Average daily number of Suspend due to PLGS. Time in suspend: Average daily duration suspended due to LGS or PLGS. 7.3 Troubleshooting Low Suspend issues I didnt see an alert message, but it appeared in History. 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. Alert Alert change LOW SUSPEND After insulin delivery automatically starts again, alert is switched to BASAL RESUMED. PRE LOW SUSPEND After insulin delivery automatically starts again, alert is switched to BASAL RESUMED. 195 B ureau Veritas 196 B ureau Veritas 8 Safety System and Alarms/Alerts 8.1 Safety System Your A7+ TouchCare System 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. If you have more than one notification, you need to clear the first notification to see the next one. Your alarm settings and alarm/alert history of the last 90 days are stored in the PDM even if the battery is depleted and will be restored once the PDM is properly charged. When the PDM battery is empty, new alarm/alert might not be successfully recorded. Note: Do NOT set alarm (time point, limit value etc.) beyond the thresholds or in a way that makes the safety system useless. Talk with your healthcare provider to see which settings are best for you. Note: Your PDM and Pump consumes battery power when notifying you of alerts, alarms, and reminders. If you do not acknowledge a notification, the PDM battery power drops fast as the notifications repeat and progress. This will result in reduced battery life and the CHARGE PDM NOW/PATCH BATT DEPLETED Alarm or PDM BATTERY LOW/PATCH BATTERY LOW alert will appear sooner than expected. 8.2 Safety Checks A single fault condition will cause the pump to suspend insulin delivery. Maximum infusion with a single fault condition is 0.05U. 8.3 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:
197 B ureau Veritas When Alarm PATCH EXPIRED occurs, the Lock Screen and Alarm screen display the following screen. Alarm on the Lock Screen Alarm on the unlocked screen If it is a high priority alarm, the PDM will display an alarm message with instructions and icon (a red triangle with three exclamation marks) in Alarm screen. If it is a medium priority alarm, the PDM will display an alarm message with instructions and icon (a red triangle with two exclamation marks) in Alarm screen. PDM Alarms in different audio modes:
Audio Mode medium priority alarm Audio Vibrate Audio and Vibrate Audio off /
Vibrate off PDM emits ten beeps every twenty seconds. PDM emits one-pulse vibration every twenty seconds PDM emits three beeps and one-pulse vibration every twenty seconds PDM emits one-pulse vibration every twenty seconds 198 B ureau Veritas Patch Pump Alarms of different priorities in different audio modes:
Audio Mode high priority alarm medium priority alarm Audio Vibrate Audio and Vibrate Audio off /
Vibrate off PDM emits ten beeps every ten seconds. PDM emits ten beeps every twenty seconds. PDM emits one-pulse vibration every ten seconds PDM emits one-pulse vibration every twenty seconds PDM emits ten beeps and one-pulse vibration every ten seconds PDM emits three beeps and one-pulse vibration every twenty seconds PDM emits ten beeps every ten seconds PDM emits one-pulse vibration every twenty seconds Audio Mode high priority alarm medium priority alarm Audio Vibrate Audio and Vibrate Audio off
/Vibrate off Patch Pump emits three beeps every one minute. Patch Pump emits three-
pulse vibration every one minute. Patch Pump emits three beeps and three-pulse vibration every one minute. Patch Pump emits three-
pulse vibration every one minute. Patch Pump emits three beeps every one minute. Patch Pump emits three-
pulse vibration every one minute. Patch Pump emits three beeps and three-pulse vibration every one minute. Patch Pump emits three-
pulse vibration every one minute. 199 B ureau Veritas Alarm sound wave:
Icon Sound wave Significance 8.3.1 PDM Alarms PDM emits ten beeps/vibrations each time. PDM emits Three beeps/vibrations each time. Patch Pump emits Three beeps/vibrations each time. Patch Pump emits Three beeps/vibrations each time. If a PDM alarm is not cleared within 10 minutes, your PDM will make a siren sound until the alarm is cleared. PDM Message Priority Reason PDM ERROR Remove device. Call customer support. PDM ERROR The PDM has restarted. Change patch. CHARGE PDM NOW Charge PDM now. A PDM error is detected. A PDM software error is detected and the PDM has restarted, but no settings have been changed. Actions to Take Tap to clear it. Remove Pump and Sensor. Contact customer support immediately. Check blood glucose. Tap to clear it. Remove the Patch Pump and change a Reservoir Patch. If the problem occurs repeatedly, please contact customer support. The PDM battery is depleted. Tap to clear it. Charge PDM battery. 200 B ureau Veritas 8.3.2 Pump Alarms When a Pump alarm occurs:
Indicator light: The indicator light on the pump flashes red once per second until the alarm is cleared. Note: If a Pump alarm is not cleared within 10 minutes, both your PDM and Patch Pump will make a siren sound until the alarm is cleared. The following table lists high priority alarm messages. PDM Message Priority Reason Actions to Take OCCLUSION DETECTED Delivery stopped. Change Patch now. PATCH ERROR Delivery stopped. Change Patch now. PUMP BASE ERROR Remove Pump. Call customer support. Pump occlusion is detected. Tap to clear it. Change Patch. Check blood glucose. A Reservoir Patch error is detected. Tap to clear it. Change Patch. Check blood glucose. A Pump Base error is detected. Tap to clear it. Remove Pump. Contact customer support immediately. Check blood glucose. The following table lists medium priority alarm messages. PDM Message Priority Reason AUTO OFF Delivery suspended. No status received. The PDM has not received a pump status during the time limit set. Actions to Take Tap to clear it. Resume basal delivery. Check blood glucose and treat it as necessary. Check Pump history. 201 B ureau Veritas PDM Message Priority Reason Actions to Take PATCH EXPIRED Delivery will stop. Change Patch now. PATCH BATT DEPLETED Delivery stopped. Change Patch now. EXCEEDS MAX TDD Exceeds max TDD. Delivery stopped. EXCEEDS MAX 1HR DELIVERY Exceeds 1 hour max. Delivery stopped. EMPTY RESERVOIR Delivery stopped. Change Patch now. LOW SUSPEND Low glucose suspend activated. The current Reservoir Patch has reached the end of its 3-day operating life. Tap to clear it. Change Patch. Check blood glucose. The Reservoir Patch battery is depleted. Tap to clear it. Change Patch. Check blood glucose. You have attempted to deliver more insulin than expected based on your Daily Max setting. You have attempted to deliver more insulin than expected based on your Hour Max setting. Tap to clear it. Check blood glucose. Resume basal delivery. Check bolus history and reevaluate your need for insulin. Continue to monitor blood glucose. Tap to clear it. Check blood glucose. Resume basal delivery. Check bolus history and reevaluate your need for insulin. Continue to monitor blood glucose. There is no insulin in the reservoir. Tap to clear it. Change Patch. Check blood glucose. The last Sensor glucose reading is at or below the Low Glucose Suspend Limit set. Tap to clear it. Check blood glucose and treat it as necessary. 202 B ureau Veritas If the following alarm is not cleared within 10 minutes, only your PDM will make a siren sound until the alarm is cleared. PDM Message Priority Reason Actions to Take PUMP OUT OF RANGE Low Suspend failed. Move PDM close to Pump. Pre Suspend failed. Move PDM close to Pump. 8.4 Alerts Low Suspend or Predictive Low Suspend failed because the PDM had lost communication with the Patch Pump. Tap to clear it. Move PDM close to Pump. Alerts are triggered by conditions that may require your attention. Alerts are less serious than alarms. You must respond to an alert by pressing buttons and/or taking actions. For example:
When Alert PATCH BATTERY LOW occurs, the Lock Screen and Alert screen display the following screen. Alert in Lock Screen Alert after unlock in Alert screen 203 B ureau Veritas The PDM displays an alert message with instructions and icon (an empty triangle with exclamation mark) in Alert screen. CGM Alerts and PDM Alerts in different audio modes:
Audio Mode Alert Audio Vibrate Audio and Vibrate Audio off
/Vibrate off PDM emits two beeps every three minutes. PDM emits one-pulse vibration every three minutes. PDM emits two beeps and one-pulse vibration every three minutes. no beeping, no vibration Patch Pump Alerts in different audio modes:
Audio Mode Alert Audio Vibrate Audio and Vibrate PDM emits two beeps every three minutes. PDM emits one-pulse vibration every three minutes. PDM emits two beeps and one-pulse vibration every three minutes. Audio off /Vibrate off no beeping, no vibration Audio Mode Alert Audio Vibrate Audio and Vibrate Audio off /Vibrate off Patch Pump emits three beeps every three minutes. Patch Pump emits three-pulse vibration every three minutes. Patch Pump emits three beeps and three-
pulse vibration every three minutes. Patch Pump emits three-pulse vibration every three minutes. 204 B ureau Veritas The sound wave of every alert beep:
Icon Sound wave Significance 8.4.1 PDM Alerts Your PDM emits two beeps every time. The following table lists alert messages for PDM. PDM Message Priority Reason Actions to Take The PDM battery is low. Tap to clear it. Charge PDM battery soon. PDM BATTERY LOW Low PDM battery. Charge battery soon. 8.4.2 Pump Alerts When a Pump alert occurs:
Indicator light: The indicator light on the Patch Pump flashes yellow once every two seconds until the alert is cleared. The following table lists alert messages for Patch Pump. PDM Message Priority Reason Actions to Take END OF SUSPEND Delivery suspended at []. LOW RESERVOIR
[] remaining. Change Patch. AUTO OFF ALERT Delivery stops if not cleared in 15 min. Insulin delivery has been suspended for more than 15 minutes. The insulin level in the Reservoir Patch has reached the set low limit. The PDM did not receive a Pump status during the time limit set. 205 Tap to clear it. Resume basal delivery. Tap to clear it. Change Patch soon. Tap to clear it. Check blood glucose. Check Pump history. B ureau Veritas PDM Message PATCH EXP ADVISORY Patch expiration in
[] hours. PATCH EXP IN 1 HOUR Patch expiration in 1h. Change Patch soon. PATCH BATTERY LOW No bolus allowed. Change Patch soon. PRE LOW SUSPEND Delivery suspended. Predictive low glucose. Priority Reason Actions to Take The Reservoir Patch will expire within the set time limit. The Reservoir Patch will expire in less than 1 hour. Tap to clear it. Change Patch soon. Tap to clear it. Change Patch soon. can about The Patch battery is running low. No be bolus delivered. Basal delivery can only last 30 minutes. The Sensor glucose may reach the Low Glucose Suspend Limit in the length of time set. Tap to clear it. Change Reservoir Patch soon. Tap to clear it. Check blood glucose and treat it as necessary. The response mode of the following alert is same as PDM alert. PDM Message Priority Reason PUMP RESTARTED Patch changed? For help call the CC. Pump restarted without Patch deactivation. Actions to Take Tap to clear it. Check if a new Patch is connected, and follow the instructions in this User Guide. Call customer support if you have any questions. 8.4.3 CGM Alerts If you set audio option to Audio off/Vibrate off, your PDM will neither beep nor vibrate for all CGM alerts, except:
206 B ureau Veritas When BELOW 3.1 mmol/L(BELOW 56 mg/dL) occurs, your PDM emits three-
pulse vibration every three minutes. If not cleared within 9 minutes, your PDM will make a siren sound until the alert is cleared. When TRANSMITTER ERROR, CHARGE TRANSMITTER, SENSOR EXPIRED, or SENSOR FAILURE occurs, your PDM emits three-pulse vibration every three minutes. The following table lists alert messages for CGM. PDM Message Priority Reason Actions to Take TRANSMITTER BATTERY LOW Charge Transmitter soon. CHARGE TRANSMITTER Charge Transmitter now. TRANSMITTER ERROR Call customer support. NO READINGS Check or change Sensor. SENSOR EXPIRED Sensor session ended. Change Sensor. SENSOR FAILURE Sensor session ended. Change Sensor. The Transmitter battery is close to running out of power. The Transmitter battery is depleted.
(MD1026) A Transmitter error is detected. The Sensor signals are abnormal. The current Sensor has reached its 14-
day operating life. The Sensor is not functioning properly. Tap to clear it. Charge Transmitter soon. Tap to clear it. Charge Transmitter. Tap to clear it. Call customer support. Tap to clear it. Check if the Sensor gets bumped or dislodged, make sure that the Sensor is inserted correctly or change Sensor. Tap to clear it. Change Sensor. Tap to clear it. Change Sensor. 207 B ureau Veritas PDM Message Priority Reason Actions to Take METER BG NOW Enter a new meter BG for calibration or tap OK to clear the alert. SENSOR CAL ERROR Enter a meter BG after 15 minutes. LOW GLUCOSE Glucose level below Low Limit. HIGH GLUCOSE Glucose level above High Limit. LOW PREDICTED Glucose may reach Low Limit in [ ] min. HIGH PREDICTED Glucose may reach High Limit in [ ] min. A meter BG is needed immediately to calibrate the Sensor. The Sensor hasn't been calibrated properly. The last Sensor glucose reading is at or below the Low Glucose Limit. The last Sensor glucose reading is at or above the High Glucose Limit. The Sensor glucose may reach Low Glucose Limit in the length of time. The Sensor glucose may reach High Glucose Limit in the length of time. Tap to clear it. Enter new meter BG for calibration or tap OK to clear the alert. Tap to clear it. Enter meter BG after 15 minutes. Tap to clear it. Check blood glucose and treat it as necessary. Continue to monitor blood glucose. Tap to clear it. Check blood glucose and treat it as necessary. Continue to monitor blood glucose. Tap to clear it. Check blood glucose and treat it as necessary. Continue to monitor blood glucose. Tap to clear it. Check blood glucose and treat it as necessary. Continue to monitor blood glucose. 208 B ureau Veritas PDM Message Priority Reason Actions to Take RAPID RISE Sensor glucose is rising rapidly. RAPID FALL Sensor glucose is falling rapidly. BELOW 3.1 mmol/L Sensor glucose below 3.1 mmol/L.
(BELOW 56 mg/dL Sensor glucose below 56 mg/dL.) SENSOR EXP IN 6 HOURS Change Sensor in 6 hours. SENSOR EXP IN 2 HOURS Change Sensor in 2 hours. SENSOR EXP IN 30 MIN Change Sensor in 30 minutes. The Sensor glucose is rising at a rate that is faster than the set Rise limit. The Sensor glucose is falling at a rate that is faster than the set Fall limit. The last Sensor glucose reading is at or below 3.1 mmol/L.
(The last Sensor glucose reading is at or below 56 mg/dL.) The current Sensor session has 6 hours left until its period ends. The current Sensor session has 2 hours left until its period ends. The current Sensor session has 30 minutes left until its period ends. Tap to clear it. Monitor trend and glucose level. Follow instructions from your healthcare provider. Tap to clear it. Monitor trend and glucose level. Follow instructions from your healthcare provider. Tap to clear it. Check blood glucose and treat it as necessary. Continue to monitor blood glucose. Tap to clear it. Change Sensor in 6 hours. Tap to clear it. Change Sensor in 2 hours. Tap to clear it. Change Sensor in 30 minutes. 209 B ureau Veritas PDM Message Priority Reason Actions to Take LOST SENSOR Move PDM close to Transmitter. The PDM has not received a signal from the Transmitter for 10 minutes. Tap to clear it. Move PDM close to Transmitter. If Alert Silence is turned on, the PDM gives no beep or vibration when an alert occurs. The ALERT SILENCE message will be displayed on your PDM screen instead, and you can check the alert in Sensor alert history. See Chapter How to use CGM system for more information. PDM Message Priority Reason Actions to Take ALERT SILENCE Alerts have occurred. Check Sensor history. Sensor alerts have occurred during silence mode. Tap to clear it. Check the Sensor Alert History. Take action based on the alert occurred. Note:
If the Audio is on and the Alert Silence is off, the audio off icon will not appear in the top right corner of this screen. If the Audio and Alert Silence are on, the temporary audio off icon will appear in the top right corner of this screen. 210 B ureau Veritas If the Audio is off, the audio off icon will appear in the top right corner of this screen. 8.5 Reminding messages Reminding messages are automatically displayed to remind you of a condition, function or event. Reminding messages include the notifications you get after setting reminders and the low-priority reminding notifications. A Message requires you to press buttons to clear it and/or to take action if necessary. For example:
When Message BASAL RESUMED occurs, the Lock Screen and Message screen display the following screen. 211 B ureau Veritas Message in Lock Screen Message after unlock in Alert screen Audio/vibration: Your PDM emits two beep and/or one vibration every three minutes, three times in total. 8.5.1 PDM reminding messages PDM Message Reason Condition CHECK SETTINGS ALARM CLOCK HIGH BG Check all settings. Alarm Clock. Treat high BG. Monitor BG. LOW BG Treat low BG. Monitor BG. 8.5.2 Pump reminding messages An error might have occurred to your settings. An alarm clock is set at this time. The blood glucose entered is higher than 13.9 mmol/L (250 mg/dL). The blood glucose entered is lower than 3.9 mmol/L (70 mg/dL). Condition PDM Message Reason CHECK BG Check your BG. BOLUS REMINDER Bolus is not delivered in specified period. BG Reminder is turned on to remind you to check meter BG after a bolus. Bolus Reminder is turned on to remind you to deliver a bolus within a specific period. 212 B ureau Veritas Condition PDM Message Reason ACTIVE BASAL EMPTY BASAL RESUMED Your active Basal is 0.00 U/H. Check BG. [ ] Basal active. The selected basal rate or temp basal rate is 0.00 U/H. The previously suspended basal rate is automatically resumed. 8.5.3 CGM reminding messages Condition PDM Message Reason SENSOR CAL REMINDER Enter a new meter BG for CAL by [ ]. SENSOR CAL FAILED Sensor calibration failed. Please retry to calibrate later. A meter BG must be entered by the time shown to calibrate Sensor. A meter BG is needed a few minutes later to calibrate the Sensor. SENSOR RECONNECT ED Old sensor disconnected. New sensor has been connected. The old sensor is disconnected and a new sensor is directly connected. 213 B ureau Veritas 214 B ureau Veritas 9 Manufacturers Declaration 9.1 Electromagnetic Emissions Emissions Test Compliance RF emissions EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007, CISPR 11:2009+A1:2010 and IEC 60601-1-2:2014 RF emissions EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007, CISPR 11:2009+A1:2010 and IEC 60601-1-2:2014 Group 1 Class B 9.2 Electromagnetic Immunity Immunity Test IEC 60601 Test Compliance Electromagnetic Level Level Environment The A7+ TouchCare System is intended for use in the electromagnetic environment specified below. The customer or user of the A7+
TouchCare System should assure that it is used in such an electromagnetic environment. Electrostatic Discharge 61000-4-2 IEC 2kV, 4kV, 8kV contact discharge 2kV,4kV,8k V, 15kV air discharge 2kV, 4kV, 8kV contact discharge 2kV,4kV, 8kV, 15kV discharge air For home healthcare environment and professional healthcare facility environment Power Port, Signal and Iterconnecting Cable Table 5 of IEC 60601-1:2014 2Kv 100Hz, During the test, the EUT can The network power supply should have the quality used in a typical 215 B ureau Veritas Immunity Test IEC 60601 Test Compliance Electromagnetic Level Level Environment The A7+ TouchCare System is intended for use in the electromagnetic environment specified below. The customer or user of the A7+
TouchCare System should assure that it is used in such an electromagnetic environment. for AC power port operate as intended commercial or hospital environment. IEC 61000-4-
4:2012 Surge IEC 61000-4-
5:2005 GB/T 17626.11 Votage dips and interruptions to AC Power Port IEC 61000-4-
11:2014 During the test, the EUT can operate as intended 0.5T(10ms);
1T (20ms);
25T(500ms)
250T(5s) 0.5kV, 1kV
(different mode) 0.5kV, 1kV, 2kV
(common mode) 0%UT0.5T
(0 45 90 135 180 225 270 and 315) 0%UT1T(0) 70%UT 20T(0) 0%UT 250T(0) The network power supply should have the quality used in a typical commercial or hospital environment. The network power supply should have the quality used in a typical commercial or hospital environment. If the A7+
user needs continuous operation during a power outage, it is recommended that the A7+ be powered by an uninterruptible power supply or battery. Suitable for most environments, if there is no industrial magnetic Power Frequency 30A/m Table 4 of IEC 60601-1-
2:2014 30A/m, 216 B ureau Veritas Immunity Test IEC 60601 Test Compliance Electromagnetic Level Level Environment The A7+ TouchCare System is intended for use in the electromagnetic environment specified below. The customer or user of the A7+
TouchCare System should assure that it is used in such an electromagnetic environment. magnetic fields IEC 61000-4-8 50HZ and 60HZ Proximity fields from RF wireless communication equipment IEC 61000-4-
3:2006+A1+A2 RF electromagnetic field immunity test IEC 61000-4-
3:2006+A1+A2 Table 9 of IEC 60601-1-
2:2014 IEC 61000-4-
3:2006+A1+A2 10V/m (for home healthcare environment and professional healthcare facility environment) 80 MHz~2.7 GHz During the test, the EUT can operate as intended 10V/m (for home healthcare environme nt) 3V/m (for professiona l healthcare facility environme nt) 80 MHz~2.7 GHz 217 equipment nearby, the magnetic field strength will not exceed 400A/m Recommended separation distance d = [12/E1] P 80 MHz to 800 MHz d = [23/E1] P 800 MHz to 6 GHz Where P is the maximum output power rating of the transmitter in watts
(W) according to the transmitter manufacturer and d is there commended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance B ureau Veritas Immunity Test IEC 60601 Test Compliance Electromagnetic Level Level Environment The A7+ TouchCare System is intended for use in the electromagnetic environment specified below. The customer or user of the A7+
TouchCare System should assure that it is used in such an electromagnetic environment. level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:
Note: UT means to the AC network voltage before the test voltage is applied. Note: At 80 MHz and 800 MHz, the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption, and reflection from structures, objects and people. Note: The table is per IEC (EN) 60601-1-2 Edition 3. Field strengths A. Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the A7+ TouchCare System is used exceeds the applicable RF compliance level above, the A7+ TouchCare 218 B ureau Veritas System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the A7+ TouchCare System. B. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m. Electrostatic discharge Although your A7+ TouchCare System is designed to be unaffected by typical levels of electrostatic discharge (ESD), very high levels of ESD can result in reset of the A7+ TouchCare System. If PDM restarts, please verify the PDM settings to ensure all settings are set to the desired values. If Pump Restarted occurs, please change a new patch. If CGM restarts, please recharge the transmitter and change a new sensor. For more information on changing a new patch, see Chapter How to use Patch Pump. For more information on changing a new sensor, see Chapter How to use CGM system (Optional). For more information on re-entering your PDM settings, see Section Settings in Chapter How to use the PDM. If you are unable to re-enter your PDM settings, change a new patch or sensor, or otherwise believe there is a problem with your device, contact your local representative. 219 B ureau Veritas Recommended separation distances between portable and mobile RF communications equipment and the A7+ TouchCare System 80 MHz~800 MHz 800 MHz~2.5 GHz Separation distance according to the frequency of transmitter (m) 150 kHz~80 MHz The A7+ TouchCare System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the A7+ TouchCare System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the A7+ TouchCare System as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter
(W) 0.01 0.1 1 10 100 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where p is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 Warning:
1. EMC (Electromagnetic Compatibility) information in this guide should be referred before installing and using the A7+ TouchCare System. 2. The A7+ TouchCare 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. 3. Portable RF Communications equipment should be used no closer than 30 cm
(12 inches) to any part of the Medtrum products. Otherwise, degradation of the performance of this equipment could result. 220 P2.1d=P2.1d=P3.2d=B ureau Veritas 4. It should be avoided to use this equipment adjacent to or stacked with other medical equipment, because it could result in improper operation. If such use is necessary, this equipment and the other medical equipment should be observed to verify that they are operating normally. 5. Other cables and accessories may negatively affect EMC performance. 221 B ureau Veritas 222 B ureau Veritas 10 Appendix I: Symbols and Icons 10.1 Product Label Symbols Symbol Meaning Symbol Meaning Lot number Reference number Manufacturer Use by: (yyyy-
mm-dd) Caution: See Instructions for use Do NOT use if package is damaged Sterilized using ethylene oxide Sterilized using radiation Follow instructions for use Radio communication Storage temperature IPX8 Waterproof to 2.5 m for 1 hour Do NOT reuse CE mark by notified body Waste Electrical and Electronic Equipment Device serial number Type BF equipment
(Protection from electrical shock) Authorized representative in the European Community 223 LOTREFSTERILEEOSTERILERSN 0197B ureau Veritas Symbol Meaning Symbol Meaning IP22 Protection Against Insertion of Large Objections and Dripping Water IEC 60529 10.2 PDM Icons Icon Meaning Icon Meaning High priority alarm Alert Audio temporary off Pump RF signal Charging Medium priority alarm Audio off 00:00 a Time Battery Charged 224 B ureau Veritas 225 B ureau Veritas 226 B ureau Veritas 11 Appendix II: Technical Information 11.1 PDM Specifications Model: FM-018 Size: 76.2 x 48.4 x 9.375mm Weight: 42.4 g Screen: 2.4 in Operating Temperature Range: +5C ~ +40C Operating Relative Humidity Range: 20%~ 90%RH Operating Atmospheric Pressure: 700~1060 hPa Storage Temperature Range: -10C ~ +55C Storage Relative Humidity Range: 20%~ 90%RH Storage Atmospheric Pressure: 700~1060 hPa Classification: Internally powered, Continuous operation Battery: Built-in 3.8 V polymer lithium ion battery Power: 5.0VDC, 1.0A Battery Life: Approximately 1 week once fully charged. Data Storage: Automatically stores the previous 90 days data Wireless Communication Distance: 10 m with the Transmitter, 4 m with the insulin pump Alarm Type: Visual, audible and vibratory Volume: 52.3 dB(A) measured from 1 m distance Limited Warranty: 4 years Dust-proof and Waterproof Rating: IP22 11.2 Patch Pump Specifications Pump Base: JN-022 Reservoir Patch: MD-JN-011 Model:
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 227 B ureau Veritas Storage Temperature Range: -10C ~ +55C Storage Relative Humidity Range: 20%~90%RH Storage Atmospheric Pressure: 700~1060 hPa Classification: Internally powered, Type BF applied parts, Continuous operation Battery: Powered by two button batteries (1.5 V) Wireless Communication Distance: 4 m Waterproof Rating: IPX8 (2.5 m, 60 min) Limited Warranty of Pump Base: 1 year Shelf Life of Reservoir Patch: 2 years Sterilization Method of Reservoir Patch: By EO gas Reservoir Volume: 200 U (2 mL) (1 U=10 L) Insulin Type Used: U-100 Basal Rate Range: 0.00~ 25 U/h (increment: 0.05 U/h) Bolus Range: 0.05 ~ 30 U (increment: 0.05 U) Bolus Delivery Rate: 0.05 U/2 s Maximum Infusion Pressure and Occlusion Pressure Threshold: 15 psi Maximum Time to Occlusion Alarm:
Bolus Volume after Occlusion Release: < 3 U Delivery Accuracy:
Accuracy Test Results (test cycle: 29 H, delivery rate: 1.0 U/H, average error:
0.40%):
Basal Delivery (0.1 U/h): < 30 h Basal Delivery (1 U/h): < 3 h Bolus Delivery (3 U at 1.5 U/min): < 120 s Basal: +/- 5% (at rates: 0.1~ 25 U/h) Bolus: +/- 5% (for all set values: 0.05 ~ 30 U) 228 B ureau Veritas 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. 229 B ureau Veritas 230 B ureau Veritas 11.3 Transmitter Specifications Model: MD1026 Size: 36.1 mm x 19.4 mm x 7.2 mm Weight: 3.57 g Operating Temperature Range: +5C ~+40C Operating Relative Humidity Range: 20%~90%RH Operating Atmospheric Pressure: 700~1060 hPa Storage Temperature Range: -10C~+55C Storage Relative Humidity Range: 20%~90%RH Storage Atmospheric Pressure: 700~1060 hPa 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 11.4 Glucose Sensor Specifications Model: MD3026 Storage Temperature Range: +2C~+30C Storage Relative Humidity Range: 20%~90%RH Storage Atmospheric Pressure: 700~1060 hPa Glucose Range: 2.2~22.2mmol/L (40~400mg/dL) SterilizationMethod: By radiation Sensor Life: Up to 14 days 11.5 CGM System Accuracy A multi-center, randomized clinic study is designed to determine the Sensor accuracy in adults with Type 1 or Type 2 diabetes. In-clinic testing consisted of frequent venous blood sample testing (by Yellow Springs Instrument 2300 STAT Plus Glucose Analyzer, YSI) on a random day in the Sensor life. The accuracy is based on the percentage of CGM glucose readings that are within 20%, 30%
or 40% of YSI values at glucose values at or above (>=) 100 mg/dL (5.6 231 B ureau Veritas mmol/L), or within 20 mg/dL (1.1 mmol/l), 30 mg/dL (1.7 mmol/L) or 40 mg/dL
(2.2 mmol/L) of YSI values at glucose values below (<) 100 mg/dL (5.6 mmol/L). 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 Matched Pairs CGM-YSI 20%/20 mg/dL 30%/30 mg/dL 40%/40 mg/dL 1678 91%
97%
99%
232 B ureau Veritas 233 B ureau Veritas 234 B ureau Veritas 12 Glossary Basal Pattern Basal Rate BG BG Target Blood Glucose (BG) Blood Glucose Meter/Meter/BG Meter Bolus Calculator Bolus Dose Bolus Reminder C Calibration Calc-C Calc-E Calc-N C-Ext. C-E CGM C-N C-Normal Combo A set of one or more basal rates that covers a 24-hour period. The amount of continuous basal insulin that is automatically delivered every hour. Abbreviation for blood glucose. See Blood Glucose. The high and low values to which your blood glucose is corrected when using the Bolus Calculator. The amount of glucose present in the blood, often measured by a blood glucose meter. A medical device used to measure the amount of glucose in the blood. A feature that calculates an estimated bolus amount based on the BG values and carbs that you enter. The amount of insulin used to cover an expected rise in glucose levels from carbohydrates, or to lower a high blood glucose value down to your target range. A Reminder that a bolus was not delivered during time periods that you specified, often set around meal times. Abbreviation for Combo Bolus. See Combo Bolus. The process of using a meter blood glucose reading or a venous blood glucose value to calculate Sensor glucose values. Combo Bolus by Bolus Calculator Extended Bolus by Bolus Calculator Normal Bolus by Bolus Calculator The extended portion of a Combo Bolus. Abbreviation for Continuous Glucose Monitoring. See Continuous Glucose Monitoring
(CGM). The normal portion of a Combo Bolus. 235 B ureau Veritas Combo Bolus Continuous Glucose Monitoring (CGM) Correction Bolus Audio off /Vibrate off E EasyLoop Extended Extended Bolus Food Bolus Food+Corr High Limit IC Ratio Insulin Sensitivity Factor (ISF) Insulin-to-Carb Ratio ISF IOB IOB Time Low Limit Manual-Bo Manual Bolus Part of the bolus amount delivered immediately, and the remainder delivered evenly over time period. A Sensor is inserted under the skin to check glucose levels in interstitial fluid. A Transmitter sends Sensor glucose readings to a display device. Bolus used to lower a high blood glucose value down to your target range. Both vibration and beep are turned off in Audio Options Abbreviation for Extended Bolus. See Extended Bolus. Safety functions including Glucose Alerts, Low Suspend and Predictive Low Suspend. Bolus amount delivered evenly over specified time period. Bolus used to cover an expected rise in glucose levels from carbohydrates. Means that a bolus that both covers carbs and corrects glucose. The value you set to determine when the system will alert you of a high Sensor glucose condition. Abbreviation for Insulin-to-Carb Ratio. See Insulin-to-Carb Ratio. The amount that blood glucose is reduced by one unit of insulin. The number of grams of carbohydrates covered by one unit of insulin. Abbreviation for Insulin Sensitivity Factor. See Insulin Sensitivity Factor (ISF). Bolus insulin delivered by the Pump that is still working to lower your blood glucose levels. A Bolus Calculator setting that lets you set the length of time that bolus insulin is tracked as IOB. The value you set to determine when the system will alert you of a low Sensor glucose condition. Manually deliver a dose of insulin. 236 B ureau Veritas Max 1h Delivery Max Bolus Max Total Daily Dose
(TDD) N Normal Bolus Note Occlusion Preset Bolus Preset Temp Basal Sensitivity Sensor Glucose (SG) Sensor Session SG Suspend Temp Basal Rate
(Temporary Basal Rate) Warning Set the maximum insulin amount that can be delivered in one hour. Set the maximum bolus amount that can be delivered in one dose. Set the maximum insulin amount that can be delivered in one day. Abbreviation for Normal Bolus. See Normal Bolus. Entire bolus amount delivered immediately. A Note provides helpful information. A blockage or interruption in insulin delivery. You can set up and save a bolus for specific meals or snacks that you frequently eat or drink. You can set up and save temporary basal rates for repeated use. See Insulin Sensitivity Factor (ISF). The amount of glucose that is present in the interstitial fluid and is measured by a glucose Sensor. The 14-day monitoring period after inserting a new Sensor. During this time frame, your glucose is being monitored and reported every two minutes, with data being sent to your display device(s). Abbreviation for Sensor glucose. See Sensor Glucose (SG). This stops all insulin delivery until you resume it. Only the basal insulin restarts when delivery is resumed. You can temporarily increase or decrease your current basal rate for a specific amount of time. A warning notifies you of a potential hazard. 237 B ureau Veritas 238 B ureau Veritas UG881116GB 348431 Version: 1.01 B ureau Veritas
1 | Label and location | ID Label/Location Info | 407.50 KiB | February 20 2020 |
VER. SYMBOL 1.00 1.01 102 103 DESCRIPTION NEW A7+
SNSN:
TouchCare DATE 2019.05.10 2019.05.21 2019.08.15 2019.09.02 DEG. DIV. 0-5 5-10 A 0.02 0.05 B 0.05 0.1 C 0.1 0.15 10-50 0.1 0.15 0.2 50-100 100-
0.15 0.2 0.25 0.15%
0.2%
0.25%
ANGLE D 0-30 0.1 31-60 61-90 0.3 0.5 4 6
. 5 1 0 0
. 8 32.53 REF MD1026 FCC ID:2AARU-MD1026 IPX8 SN: XXXXXXXX 36.10 0 4
. 9 1 TouchCare label location REVISION VIEW DIRECTION Unit Scale MM 1:1 APPROVAL M D Y Material CHECK DESCRIPTION Medtrum FINISH LASER DESIGN XYF M D Y DATE DESIGN CHECK APPROVAL VER. Q'TY 1.03 1 M D Y 05 10 19 DRAW XYF M D Y 05 10 19 MODEL MD1026 PART NAME MD1026 FILE NO 761026LANEU COPY& USE FOR ANY PURPOSE NEED WRITTEN PERMISSION FROM SHANGHAI MEDTRUM ALL DIMENSIONS IN mm; DON'T SCALE THIS DRAWING
1 | Authorization Letter | Cover Letter(s) | 62.89 KiB | February 20 2020 |
Tel: 408-526-1188 Fax: 408-526-1088 Email: sales.eaw@us.bureauveritas.com 775 Montague Expressway Milpitas, CA 95035 Project and Product Certification Representative Authorization Letter Reason for Amendment (current / obsolete) Initial Release (obsolete) Revised wording (obsolete) Updated company template (obsolete) Updated letter information (obsolete) Added FCC ID field (obsolete) Updated company name & logo (current) Revision History From 1.0 1.0 2.0 3.0 4.0 5.0 To 1.0 2.0 3.0 4.0 5.0 6.0 Approved Date Nov-14-2006 Sept25-2007 Jan-31-2012 May-23-2014 Sep-16-2014 Jun-27-2018 SCS-F18: Project and Product Certification Representative Authorization Letter Page 1 of 2 Rev 6.0 MEDTRUM TECHNOLOGIES Inc.
(2020/01/03) To: BVCPS, INC. 775 Montague Expressway, Milpitas, CA 95035 USA Dear Sir/Madam, Re: Project and Product Certification Representative Authorization Letter We, MEDTRUM TECHNOLOGIES Inc. hereby authorize Bureau Veritas Consumer Product Services, Inc. to act as a Certification Body for certifying for the following project(s):
FCC ID: 2AARU-MD1026 Product Description: Transmitter Model: MD1026 We affirm that between Bureau Veritas Consumer Product Services, Inc. and ____ MEDTRUM TECHNOLOGIES Inc ___, any difference in understanding, including test plan, measurement methods, applicable standards and relevant procedures and processes have been resolved prior to commencement of testing activities. Sincerely, Clients signature:
Clients name / title: Sherry He Contact information / address : 7F, Buiding 8, 200 Niudun Rd Shanghai SCS-F18: Project and Product Certification Representative Authorization Letter Page 2 of 2 Rev 6.0
1 | LTC Letter | Cover Letter(s) | 99.62 KiB | February 20 2020 |
775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: sales.eaw@us.bureauveritas.com Confidentiality Request Letter Reason for Amendment (current / obsolete) Initial Release (obsolete) Adding CFR 2.459 (obsolete) Updated company template & Added text box
(obsolete) Added IC confidentiality letter form (obsolete) Corrections to STC form. Added reference to KDB
(obsolete) Updated company logo (current) Revision History From 1.0 1.0 2.0 3.0 4.0 5.0 To 1.0 2.0 3.0 4.0 5.0 6.0 Approved Date Nov-14-2006 August 11 - 2008 Jan-31-2012 March-26-2015 Nov-19-2015 Jun-26-2019 SCS-F19: Confidentiality Request Letter Page 1 of 2 Rev 6.0 MEDTRUM TECHNOLOGIES Inc.
(2020/01/03) To:
Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD Subject: Permanent Confidentiality Request for FCC ID: 2AARU-MD1026 Pursuant to sections 0.457 and 0.459 of CFR 47, we respectfully request permanent confidential treatment of the following Exhibits accompanying this application as:
- Block Diagram
- Schematics
- Operational Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Clients signature:
Clients name / title: Sherry He Contact information / address : 7F, Buiding 8, 200 Niudun Rd Shanghai SCS-F19: Confidentiality Request Letter Page 2 of 2 Rev 6.0
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2020-02-20 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2020-02-20
|
||||
1 | Applicant's complete, legal business name |
MEDTRUM TECHNOLOGIES Inc.
|
||||
1 | FCC Registration Number (FRN) |
0024765067
|
||||
1 | Physical Address |
7F, Buiding 8, 200 Niudun Rd
|
||||
1 |
Shanghai, N/A
|
|||||
1 |
China
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
t******@siemic.com
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2AARU
|
||||
1 | Equipment Product Code |
MD1026
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
S**** H********
|
||||
1 | Telephone Number |
86-21******** Extension:
|
||||
1 | Fax Number |
86-21********
|
||||
1 |
h******@medtrum.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Transmitter | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power listed is the maximum conducted output power. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Bureau Veritas (Shenzhen) Consumer Products Servic
|
||||
1 | Name |
M****** H******
|
||||
1 | Telephone Number |
+ (86********
|
||||
1 |
a******@cn.bureauveritas.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0020000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC