Medtrum A7 TouchCare User manual

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.
Medtrum Technologies Inc.
7F, Building 8, No. 200, Niudun
Road
Shanghai 201203, China
Tel: [phone]
Fax: [phone]
www.medtrum.com
Medtrum Ltd.
Citibase Watford
42-44 Clarendon Road
Watford, WD17 1JJ
United Kingdom
Tel: [phone]
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

Contents
目录
1 Introduction............................................................................................................. 1
1.1 Before you begin.......................................................................................... 1
1.2 Indications.................................................................................................... 2
1.3 Contraindications......................................................................................... 2
1.4 User Safety....................................................................................................3
1.4.1 Warnings and Precautions................................................................ 3
1.4.2 Consumables.....................................................................................6
1.4.3 Radio Frequency (RF) Communication............................................. 7
1.4.4 Emergency Kit................................................................................... 8
1.4.5 Water................................................................................................ 9
1.4.6 Storage.............................................................................................. 9
1.4.7 FCC Caution..................................................................................... 10
1.4.8 IC Caution........................................................................................11
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

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..................................................................... 25
3.2.3 Time and Date.................................................................................25
3.2.4 Bolus Calculator.............................................................................. 26
4 Safety System and Alarms..................................................................................... 28
4.1 Safety System............................................................................................. 28
4.2 Safety Checks..............................................................................................28
5 Troubleshooting.....................................................................................................30
6 Manufacturer’s Declaration...................................................................................31
6.1 Electromagnetic Emissions.........................................................................31
6.2 Electromagnetic Immunity......................................................................... 32
7 Appendix I: Symbols and Icons.............................................................................. 34
7.1 Product Label Symbols............................................................................... 34
7.2 PDM Icons...................................................................................................36
8 Appendix II: Technical Information........................................................................37
8.1 Patch Pump Specifications......................................................................... 37
8.2 PDM Specifications.....................................................................................40
8.3 Transmitter Specifications..........................................................................41
8.4 Glucose Sensor Specifications.................................................................... 42
8.5 CGM System Accuracy................................................................................43

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
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:
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
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
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 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.
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
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 2.0 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
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 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 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 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:
• 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 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.
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.