A7 TouchCare®
Insulin Management System
User Guide
©2018, Medtrum Technologies Inc. All rights reserved.
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.
Citibase Watford
42-44 Clarendon Road
Watford, WD17 1JJ
United Kingdom
Tel: +44 1923312391
0197
This product complies with
Directive 93/42/EEC (MDD) and
Directive 2014/53/EU (RED).
REF MD-SY-011C
Version: 1.0
Publication date:
4 Sep, 2018
UG882111GB
348300
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.
Contents
1 Introduction
1.1 Before you begin
1.2 Indications
1.3 Contraindications
1.4 User Safety
1.5 Warranty Information
Warranty
Warranty
Warranty
2 Your A7 TouchCare® System
2.1 Personal Diabetes Manager (PDM)
2.2 Patch Pump
2.3 Glucose Sensing System (Optional)
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1.4.1 Warnings and Precautions
1.4.2 Consumables
1.4.3 Radio Frequency (RF) Communication
1.4.4 Emergency Kit
1.4.5 Water
1.4.6 Storage
1.4.7 FCC Caution
1.4.8 IC Caution
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Personal Diabetes Manager (PDM)
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Pump Base
Transmitter
Personal Diabetes Manager (PDM) (MD-FM-008)
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目录
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USB charging cable
3 How to Use the PDM
3.1 Basics of the PDM
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3.1.1 Turn on/off the PDM
3.1.2 Charge the PDM
3.1.3 Power Mode
3.1.4 Scroll Bar
3.1.5 Beep/Vibrate
3.2 Setting up the PDM
3.2.1 Select a Language
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3.2.2 Select country/region
3.2.3 Time and Date
3.2.4 Bolus Calculator
4 Safety System and Alarms
4.1 Safety System
4.2 Safety Checks
5 Troubleshooting
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6 Manufacturer’s Declaration
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6.1 Electromagnetic Emissions
6.2 Electromagnetic Immunity
7 Appendix I: Symbols and Icons
7.1 Product Label Symbols
7.2 PDM Icons
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8 Appendix II: Technical Information
8.1 Patch Pump Specifications
8.2 PDM Specifications
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8.3 Transmitter Specifications
8.4 Glucose Sensor Specifications
8.5 CGM System Accuracy
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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. After adequate training and practice, you
will find it easy to enter and change the system’s 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 with the A7
TouchCare® Pump:
Humalog®, NovoLog®, and Apidra®.
Before using different insulin with this Pump, check the insulin label to make
sure it can be used with your Pump. Use of any insulin with lesser or greater
concentration can result in serious injury or 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
Maintain contact with their healthcare provider.
Test their blood glucose levels as recommended by their healthcare
Maintain sufficient diabetes self-care skills.
Recognize and respond to alerts and alarms. (Sufficient vision and/or
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.
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:
provider.
hearing are required.)
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. 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.
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.
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 they are familiar with any
information given by your healthcare provider.
Patch Pump
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
this will help to avoid the risk of diabetic ketoacidosis (DKA) or very high blood
glucose (BG).
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.
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
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.
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.
Personal Diabetes Manager (PDM)
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, inspect it to
be sure it is still
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 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 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.
Cleaning
Reservoir Patch—The Pump Base (MD-JN-012) 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 Sensor—The Transmitter (MD-TY-012) is used with the Medtrum
Glucose Sensor (MD-JY-006/JY-016). Change your JY-006 Glucose Sensor
every seven days or change your JY-016 Glucose Sensor every fourteen days.
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
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 interference to radio
communications. There are no guarantees that interference will not occur in a
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:
• 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.
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
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
Extra AAA alkaline batteries
Instructions from your healthcare provider about how much insulin to
Alcohol wipes
Glucagon emergency kit
Emergency contact phone numbers
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:
inject if pump delivery is interrupted
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.
Warning: The PDM is not waterproof. Do NOT spill fluids on it or drop it into
fluids.
Warning: The Patch Pump may not be able to deliver normally in water. The
Transmitter may not be able to send data normally in water.
Note: Hot water may decrease Sensor life.
1.4.6 Storage
Store the Pump Base and Reservoir Patch at temperatures between -10°C (14°F)
and 55°C (131°F), and at humidity levels between 20% and 90% relative
humidity. Do NOT store the Pump Base and Reservoir Patch in direct sunlight,
extreme temperatures, or in very humid areas.
Store the Sensor at temperatures between 2°C (36°F) and 30°C (86°F), and at
humidity levels between 20% and 90% relative humidity for the length of the
Sensor’s shelf life. For temperatures greater than 30°C (86°F), the Sensor will
require cooled storage at temperatures no lower than 2°C (36°F). 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 -10°C (14°F) and 55°C (131°F),
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 -10°C
(14°F) and 55°C (131°F), 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
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 licence-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
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
During the Warranty Period, Medtrum will, at its discretion, either repair or replace
(with a new or recertified PDM, at Medtrum’s 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 Medtrum’s
instructions and will not apply:
original end use purchaser (the “Warranty Period”).
• 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;
• If a
charger without matching
• 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.
is used with the PDM
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.
Warranty
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 Medtrum’s
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
Medtrum’s 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
• 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.
Warranty
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 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.
The warranty is valid only if the Transmitter is used in accordance with
Medtrum’s 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.
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.
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.
Personal Diabetes Manager (PDM) (MD-FM-008)
2.2 Patch Pump
1. Power Key
2. Home Key (Softw Key)
3. Charging Port
4. Sound Hole
5. Charging Indicator
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
precise dispensing screw, a plunger, a driver, 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
(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.
The Transmitter records Sensor data and sends data to a display device via
wireless RF communication. The Transmitter’s USB charging cable is also
included in the package.
Glucose Sensor
(MD-JY-006 or JY-016)
(Consumable)
Transmitter
(MD-TY-012)
USB charging cable
3 How to Use the PDM
When you long-press the power key, then a green light will flash, the
When you short-press the power key, a yellow light will go on for about 8
When you long-press the power key for about 2 seconds, the shutdown
3.1 Basics of the PDM
3.1.1 Turn on/off the PDM
1) Turn-on
screen will light up, the PDM is successfully turned on.
seconds but the PDM is not turned on.
1) Turn-off
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 key for about 6 seconds, a yellow light will go
on for about 2 seconds, indicating that the shutdown is completed.
Do not use other types of chargers. Otherwise the PDM may not work
You must charge the PDM when the battery is low to keep using the PDM.
Even if the PDM is exhausted, or if the PDM is mistaken, the setup
It takes at least 1 hour to fully charge. Usually, the handheld is fully
Blue light flashes when PDM is charging, and the green light is always on
Don’t change the battery of the PDM at any time.
Only person（including patient）with adequate training is permitted to
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.
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:
normally.
If the battery is exhausted, the PDM will shut down automatically.
information stored in the PDM will not be lost.
charged, available for handhelds for 1 weeks.
indicates full charge.
operate the PDM.
1. Sleep Mode
a. The activated basal, temporary basal and all bolus functions will not be
b. The screen will be locked after screen backlight timeout.
c. Press Power key, and the screen lights up, the PDM displays the Lock
2. Awake Mode
3.1.3 Power Mode
The PDM has two power modes:
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.
changed.
Screen. When PDM is displaying a certain screen before it turns to Lock
Screen, PDM will show the previous screen after the screen is unlocked.
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 key.
b. In the Sleep Mode, all Alert 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.
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 “Setup”, the Bolus Calculator function will be forced to turn on;
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. However, only
the remaining alarm/alert conditions will be recorded after the new battery is
installed.
Note: Do NOT set alarm (time point, limit value etc.) beyond the thresholds or
in a way that makes the alarm system useless. Talk with your healthcare
provider to see which settings are best for you.
Note: Your PDM 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 Alarm screen will appear
sooner than expected.
4.2 Safety Checks
A single fault condition will cause the pump to suspend insulin delivery.
Maximum infusion with a single fault condition is 0.05U.
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
Emissions Test
Compliance
RF emissions
EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007, CISPR
11:2009+A1:2010and IEC 60601-1-2:2014
Group 1
RF emissions
EN 60601-1-2:2007+AC:2010, IEC 60601-1-2:2007, CISPR
11:2009+A1:2010and IEC 60601-1-2:2014
Class B
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.
6.1 Electromagnetic Emissions
6.2 Electromagnetic Immunity
Immunity Test
IEC 60601 Test Level
Compliance Level
Electrostatic discharge
(ESD)
IEC 61000-4-2
±2.0 kV, ±4.0 kV, ±6.0kV,
±8.0 kV contact discharge
±2.0 kV, ±4.0 kV, ±8.0 kV,
±15.0 kV air discharge
±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)
RF electromagnetic
field immunity test
IEC 61000-4-3
10 V/m
10 V/m
Power frequency
magnetic fields
IEC 61000-4-8
30 A/m
30 A/m
Warning:
1. Medtrum MD-SY-011C system is not designed to be used in an environment
with high voltage, high-intensity magnetic field, where the intensity of EM
DISTURBANCES is high.
2. Portable RF Communications equipment should be used no closer than 30
cm (12 inches) to any part of the Medtrum products. Otherwise, degradation
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
Symbol
Meaning
Symbol
Meaning
LOT
Lot number
Do NOT use if
package is
damaged
REF
Reference
number
STERILE EO
Sterilized using
ethylene oxide
Manufacturer
STERILE R
Sterilized using
radiation
Use by:
(yyyy-mm-dd)
Follow
instructions for
use
Caution: See
Instructions for
use
Radio
communication
7.1 Product Label Symbols
Symbol
Meaning
Symbol
Meaning
Storage
temperature
IPX8
Waterproof to
2.5 m for 1
hour
Do NOT reuse
SN
Device serial
number
0197
CE mark by
notified body
Type BF
equipment
(Protection
from electrical
shock)
Waste
Electrical and
Electronic
Equipment
Authorized
representative
in the
European
Community
IP22
Protection
Against
Insertion of
Large
Objections and
Dripping Water
IEC 60529
7.2 PDM Icons
Icon
Meaning
Icon
Meaning
High priority
alarm
Medium
priority alarm
Alert
Audio off
Audio
temporary off
00:00 am
Time
Pump RF signal
Battery
Charging
Charged
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
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 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 1.5 U/min): < 120 s
Bolus Volume after Occlusion Release: < 3 U
Delivery Accuracy:
Basal: +/- 5% (at rates: 0.1~ 10 U/h)
Bolus: +/- 5% (for all set values: 0.05 ~ 25 U)
Accuracy Test Results (test cycle: 29 H, delivery rate: 1.0 U/H, average error:
0.40%):
Note: The Patch Pump may not be able to achieve the above measurement
accuracy under certain circumstances such as vigorous exercise, or abnormal
operating conditions.
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, 1.0A
Battery Life: Approximately 1 weeks for 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
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 (2.5 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
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)
SterilizationMethod: By radiation
Sensor Life: Up to 14 days
8.5 CGM System Accuracy
Number of
Matched Pairs
CGM-YSI
±20%/20 mg/dL
±30%/30 mg/dL
±40%/40
mg/dL
1678
91%
97%
99%
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
(5.6 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.
UG882111GB
348300
Version: 2.8
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