Medtrum A7 TouchCare User Manual
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Medtrum A7 TouchCare User Manual

Insulin management system
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A7 TouchCare®
Insulin Management System
User Guide

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Summary of Contents for Medtrum A7 TouchCare

  • Page 1 A7 TouchCare® Insulin Management System User Guide...
  • Page 2 ©2018, Medtrum Technologies Inc. All rights reserved. Humalog® is a trademark of Eli Lilly and Company. NovoLog® is a trademark of Novo Nordisk A/S. Apidra® is a trademark of Sanofi S.A. 0197 Medtrum Technologies Inc. This product complies with 7F, Building 8, No. 200, Niudun...

  • Page 3: Table Of Contents

    1.5 Warranty Information................12 Warranty......................12 Personal Diabetes Manager (PDM)............12 Warranty......................13 Pump Base....................13 Warranty......................14 Transmitter....................14 2 Your A7 TouchCare® System..................17 2.1 Personal Diabetes Manager (PDM)............17  Personal Diabetes Manager (PDM) (MD-FM-008)......18 2.2 Patch Pump....................18 2.3 Glucose Sensing System (Optional)............19...
  • Page 4  USB charging cable................20 3 How to Use the PDM..................... 21 3.1 Basics of the PDM..................21 3.1.1 Turn on/off the PDM...............21 3.1.2 Charge the PDM................22 3.1.3 Power Mode..................23 3.1.4 Scroll Bar..................24 3.1.5 Beep/Vibrate...................24 3.2 Setting up the PDM..................24 3.2.1 Select a Language................24 3.2.2 Select country/region..............

  • Page 5: Introduction

    1.1 Before you begin Check with your healthcare provider 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.

  • Page 6: Indications

    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.

  • Page 7: User Safety

    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.
  • Page 8 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®...
  • Page 9 PDM and voids its warranty. Operating Temperature Range Your A7 TouchCare® System is designed to operate between 5°C (41°F) and 40°C (104°F). Do NOT expose the system to temperatures outside that range. Do NOT expose the system to direct sunlight for a long period of time.

  • Page 10: Consumables

    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.

  • Page 11: Radio Frequency (Rf) Communication

    • 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®...

  • Page 12: Emergency Kit

    Urine ketone testing supplies  Insulin syringe  Rapid-acting U-100 insulin  Extra Medtrum 2.0 mL Reservoir Patches  Extra AAA alkaline batteries  Instructions from your healthcare provider about how much insulin to  inject if pump delivery is interrupted Alcohol wipes ...

  • Page 13: Water

    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.

  • Page 14: Fcc Caution

    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.

  • Page 15: Ic Caution

    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 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.

  • Page 16: Warranty Information

    PDM is repaired or replaced, the warranty period shall not be extended. The warranty is valid only if the PDM is used in accordance with Medtrum’s instructions and will not apply: • If damage results from changes or modifications made to the PDM by the user or third persons after the date of manufacture;...

  • Page 17: Warranty

    (the “Warranty Period”). During the Warranty Period, Medtrum will, at its discretion, either repair or replace (with a new or recertified Pump Base, at Medtrum’s discretion) any defective Pump Base, subject to the conditions and exclusions stated herein.

  • Page 18: Warranty

    • 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;...
  • Page 19 “Warranty Period”). During the Warranty Period, Medtrum will, at its discretion, either repair or replace (with a new or recertified Transmitter at Medtrum’s discretion) any defective Transmitter, subject to the conditions and exclusions stated herein. This Warranty applies only to new devices and, in the event the Transmitter is repaired or replaced, the warranty period shall not be extended.
  • Page 20 EXCLUDED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.

  • Page 21: Your A7 Touchcare® System

    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.

  • Page 22: Personal Diabetes Manager (Pdm) (Md-Fm-008)

    1. Power Key 2. Home Key (Softw Key) 3. Charging Port 4. Sound Hole 5. Charging Indicator  Personal Diabetes Manager (PDM) (MD-FM-008) 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.

  • Page 23: Glucose Sensing System (Optional)

    (MD-JN-012) 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.

  • Page 24: Usb Charging Cable

    Glucose Sensor  Transmitter  (MD-JY-006 or JY-016) (MD-TY-012) (Consumable) USB charging cable ...

  • Page 25: How To Use The Pdm

    3 How to Use the PDM 3.1 Basics of the PDM 3.1.1 Turn on/off the PDM 1) Turn-on When you long-press the power key, then a green light will flash, the  screen will light up, the PDM is successfully turned on. When you short-press the power key, a yellow light will go on for about 8 ...

  • Page 26: Charge The Pdm

    Or you long-press the power key for about 6 seconds, a yellow light will go  on for about 2 seconds, indicating that the shutdown is completed. 3.1.2 Charge the PDM It is recommended to fully charge the PDM the first time it is used. As a safety measure, the PDM will give you "...

  • Page 27: Power Mode

    operate the PDM. 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 Key.

  • Page 28: Scroll Bar

    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. 3.1.5 Beep/Vibrate The PDM beeps and/or vibrates to notify you of a condition. For more information about Beep/Vibrate.

  • Page 29: Select Country/Region

    You can change language. 3.2.2 Select country/region Select your country/region, then tap Next. 3.2.3 Time and Date When starting PDM for the first time, you need to set the time and date.

  • Page 30: Bolus Calculator

    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. 3.2.4 Bolus Calculator After you finish the settings for date and time, you can choose whether you shall use the Bolus Calculator.
  • Page 31 If you choose “Skip”, the Bolus Calculation function will stay turned-off.

  • Page 32: Safety System And Alarms

    4 Safety System and Alarms 4.1 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.
  • Page 33 Maximum infusion with a single fault condition is 0.05U.

  • Page 34: Troubleshooting

    5 Troubleshooting This chapter 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.

  • Page 35: Manufacturer's Declaration

    Pump Base, MD-JN-011 Reservoir Patch, MD-TY-012 Transmitter and MD-JY-006/JY-016 Glucose Sensor) is intended for use in the electromagnetic environment specified below. The customer or the user of A7 TouchCare® System should make sure that it is used in such an environment.

  • Page 36: Electromagnetic Immunity

    IEC 61000-4-8 Warning: 1. Medtrum MD-SY-011C system is not designed to be used in an environment with high voltage, high-intensity magnetic field, where the intensity of EM DISTURBANCES is high. 2. Portable RF Communications equipment should be used no closer than 30...
  • Page 37 of the performance of this equipment could result. 3. 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.

  • Page 38: Appendix I: Symbols And Icons

    7 Appendix I: Symbols and Icons 7.1 Product Label Symbols Symbol Meaning Symbol Meaning Do NOT use if Lot number package is damaged Reference Sterilized using STERILE EO number ethylene oxide Sterilized using Manufacturer STERILE R radiation Follow Use by: instructions for (yyyy-mm-dd) Caution: See...
  • Page 39 Symbol Meaning Symbol Meaning Waterproof to Storage IPX8 2.5 m for 1 temperature hour Device serial Do NOT reuse number Type BF equipment 0197 CE mark by (Protection notified body from electrical shock) Authorized Waste representative Electrical and in the Electronic European Equipment...

  • Page 40: Pdm Icons

    7.2 PDM Icons Icon Meaning Icon Meaning High priority Medium alarm priority alarm Alert Audio off Audio 00:00 am Time temporary off Pump RF signal Battery Charging Charged...

  • Page 41: Appendix Ii: Technical Information

    8 Appendix II: Technical Information 8.1 Patch Pump Specifications Model: Pump Base: MD-JN-012 Reservoir Patch: MD-JN-011 Size: 56.5mm x 33.3mm x 13.3 mm Weight: 21.5 g (without insulin) Operating Temperature Range: +5 °C ~ +40 °C Operating Relative Humidity Range: 20%~90%RH Operating Atmospheric Pressure: 700~1060 hPa Storage Temperature Range: -10°C ~ +55°C Storage Relative Humidity Range: 20%~90%RH...
  • Page 42 Shelf Life of Reservoir Patch: 2 years Sterilization Method of Reservoir Patch: By EO gas Reservoir Volume: 200 U (2 mL) (1 U=10 μL) Insulin Type Used: U-100 0.00~ 10 U/h Basal Rate Range: (increment: 0.05 U/h) Bolus Range: 0.05 ~ 25 U (increment: 0.05 or 0.1 U) Bolus Delivery Rate: 0.05 U/2 s Maximum Infusion Pressure and Occlusion Pressure Threshold: 15 psi Maximum Time to Occlusion Alarm:...
  • Page 43 Note: The Patch Pump may not be able to achieve the above measurement accuracy under certain circumstances such as vigorous exercise, or abnormal operating conditions.

  • Page 44: Pdm Specifications

    8.2 PDM Specifications Model: MD-FM-008 Size: 76.2 x 48.4 x 9.375mm Weight: 42.4 g Screen: 2.4 in Operating Temperature Range: +5°C ~ +40°C 20%~ 90%RH Operating Relative Humidity Range: Operating Atmospheric Pressure: 700~1060 hPa ~ +55 Storage Temperature Range: °C °C 20%~ 90%RH Storage Relative Humidity Range:...

  • Page 45: Transmitter Specifications

    Limited Warranty: 4 years Dust-proof and Waterproof Rating: IP22 8.3 Transmitter Specifications Model: MD-TY-012 Size: 36.1 mm x 19.4 mm x 12 mm Weight: 4.8 g Operating Temperature Range: +5°C ~+40°C Operating Relative Humidity Range: 20%~90%RH Operating Atmospheric Pressure: 700~1060 hPa Storage Temperature Range: -10°C~+55°C Storage Relative Humidity Range: 20%~90%RH Storage Atmospheric Pressure: 700~1060 hPa...

  • Page 46: Glucose Sensor Specifications

    8.4 Glucose Sensor Specifications Model: MD-JY-006 Storage Temperature Range: +2°C ~+30°C Storage Relative Humidity Range: 20%~90%RH Storage Atmospheric Pressure: 700~1060 hPa Glucose Range: 2.2~22.2 mmol/L (40~400 mg/dL) Sterilization Method: By radiation Sensor Life: Up to 7 days Model: JY-016 Storage Temperature Range: +2°C~+30°C Storage Relative Humidity Range: 20%~90%RH Storage Atmospheric Pressure: 700~1060 hPa Glucose Range:2.2~22.2mmol/L (40~400mg/dL)

  • Page 47: Cgm System Accuracy

    8.5 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™...
  • Page 48 UG882111GB 348300 Version: 2.8...

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