A7 TouchCare® Insulin Management System User Guide
©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. 7F, Building 8, No. 200, Niudun Road Shanghai 201203, China Tel: +86-21-50274781 Fax: +86-21-50274779 www.medtrum.com Medtrum Ltd.
Contents 目录 1 Introduction............................................................................................................. 1 1.1 Before you begin.......................................................................................... 1 1.2 Indications.................................................................................................... 2 1.3 Contraindications......................................................................................... 2 1.4 User Safety...............
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................................................................
1 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. Your healthcare provider can provide you with the initial settings of your insulin Pump and CGM system.
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.
1.4 User Safety 1.4.1 Warnings and Precautions General Make sure that you have read and are familiar with the User Guide before using the A7 TouchCare® System. Failure to follow the instructions may result in pain or injury and may also affect the system’s performance. If you do not understand something or have questions, ask your healthcare provider, call customer support, or contact your local Medtrum distributor. The A7 TouchCare® System has many different settings and features.
Do NOT operate your A7 TouchCare® System in the presence of flammable anesthetics or explosive gases. 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.
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. 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.
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.
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.
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: Fast-acting glucose tablets or gel BG monitoring supplies Urine ketone testing supplies Insulin syringe Rapid-acting U-100 insulin Extra Medtrum 2.
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 the devices are securely attached and in place.
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 -10°C (14°F) and 55°C (131°F), and at humidity levels between 20% and 90% relative humidity.
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.
1.5 Warranty Information Warranty 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”).
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.
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 • If damage results from negligence or improper use, including but not limited to improper storage or physical abuse such as dropping or otherwise.
“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.
EXCLUDED, INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
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.
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. 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.
Reservoir Patch (MD-JN-011)(Consumable) Pump Base (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. The Sensor is the applied part of the Glucose Sensing System.
Glucose Sensor (MD-JY-006 or JY-016) (Consumable) USB charging cable Transmitter (MD-TY-012)
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 seconds but the PDM is not turned on. 1) Turn-off When you long-press the power key for about 2 seconds, the shutdown screen appears.
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 " PDM BATTERY LOW " or " PDM CHARGE 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.
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. 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 key, and the screen lights up, the PDM displays the Lock Screen.
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. 3.2 Setting up the PDM 3.2.1 Select a Language Select your language, then tap Next.
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.
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. Tap “Yes” to enter Bolus Calc Setup. Tap “No” to go directly to Lock Screen.
If you choose “Skip”, the Bolus Calculation function will stay turned-off.
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. All of your alarm settings and alarm history are stored in the PDM if the battery is removed and will be restored once a new battery is installed.
Maximum infusion with a single fault condition is 0.05U.
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. it on.
6 Manufacturer’s Declaration The A7 TouchCare® System (consisting of the MD-FM-008 PDM, MD-JN-012 Pump Base, MD-JN-011 Reservoir Patch, MD-TY-012 Transmitter and MD-JY-006/JY-016 Glucose Sensor) is intended for use in the electromagnetic environment specified below. The customer or the user of A7 TouchCare® System should make sure that it is used in such an environment. 6.
6.2 Electromagnetic Immunity Immunity Test IEC 60601 Test Level Electrostatic discharge ±2.0 kV, ±4.0 kV, ±6.0kV, (ESD) ±8.0 kV contact discharge IEC 61000-4-2 ±2.0 kV, ±4.0 kV, ±8.0 kV, ±15.0 kV air discharge RF electromagnetic 10 V/m field immunity test Compliance Level ±2.0 kV, ±4.0 kV, ±6.0 kV, ±8.0 kV contact(56% RH) ±2.0 kV, ±4.0 kV, ±8.0 kV, ±15.0 kV air (56% RH) 10 V/m IEC 61000-4-3 Power frequency magnetic fields 30 A/m 30 A/m IEC 61000-4-8 Warning: 1.
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.
7 Appendix I: Symbols and Icons 7.
Symbol 0197 IP22 Meaning Symbol Meaning Storage temperature IPX8 Waterproof to 2.
7.
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.
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 Basal Rate Range: 0.00~ 10 U/h (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: Basal Delivery (0.1 U/h): < 30 h Basal Delivery (1 U/h): < 3 h Bolus Delivery (3 U at 1.
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.
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 Operating Relative Humidity Range: 20%~ 90%RH Operating Atmospheric Pressure: 700~1060 hPa Storage Temperature Range: -10°C ~ +55°C Storage Relative Humidity Range: 20%~ 90%RH Storage Atmospheric Pressure: 700~1060 hPa Classification: Internally powered, Continuous operation Battery: Built-in 3.8 V polymer lithium ion battery Power: 5.0VDC, 1.
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 Battery: Built-in 3.7 V polymer lithium ion battery Waterproof Rating: IPX8 (2.
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.
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™ Glucose Analyzer, YSI) on a random day in the 7-day 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.
UG882111GB 348300 Version: 2.
