Before you begin ...........................................................................................................................................................4
About radio frequency (RF) communication ................................................................................................................... 8
Avoid extreme temperature .......................................................................................................................................... 10
Water and your Patch .................................................................................................................................................... 10
The basics ........................................................................................................................................................................... 11
Introduction to insulin pump therapy .......................................................................................................................... 11
How does the system work? ........................................................................................................................................ 11
Key features ................................................................................................................................................................ 13
No tubing ....................................................................................................................................................................... 13
A fully‐integrated design ................................................................................................................................................ 14
Record keeping .............................................................................................................................................................. 14
The personal diabetes manager (PDM) ........................................................................................................................ 16
HOME screen ................................................................................................................................................................. 19
Time ....................................................................................................................................................................... 20
Alert and alarm icons ............................................................................................................................................. 21
RF signal icon ......................................................................................................................................................... 21
Scroll bar ........................................................................................................................................................................ 22
MAIN MENU ........................................................................................................................................................... 23
BOLUS MENU ......................................................................................................................................................... 23
BASAL MENU .......................................................................................................................................................... 24
PATCH MENU .......................................................................................................................................................... 24
UTILITIES MENU ..................................................................................................................................................... 24
HISTORY MENU ...................................................................................................................................................... 25
STATUS screen ................................................................................................................................................................ 25
Using the Patch Pump ......................................................................................................................................................... 27
How to change a new Patch? ....................................................................................................................................... 27
Prepare your Patch Pump for use .................................................................................................................................. 29
Deactivate the current Reservoir Patch ................................................................................................................. 30
Connect the Pump Base to a new Patch ................................................................................................................ 33
Fill the new Patch ........................................................................................................................................................... 34
Select and prepare the infusion site .............................................................................................................................. 37
Attach the new Patch ..................................................................................................................................................... 40
Start the insulin delivery with the Patch ........................................................................................................................ 41
Pump safety system and alarms .......................................................................................................................................... 43
Safety system .............................................................................................................................................................. 43
Alerts and Alarms ....................................................................................................................................................... 43
2
Appendix I: Symbols and icons ............................................................................................................................................ 47
Check with your health care professional regarding your individual training needs. Do NOT attempt to connect to
your pump before you have been trained on your pump.
As part of your training, your health care professional will work with you to establish diabetes management guidelines
and settings that best fit your needs as your insulin pump settings impact the calculations for insulin delivery. You will
rely on your healthcare professional for a lot of critical information about your pump system, especially during the first
few weeks and months. Your healthcare professional must help you enter the initial settings into the Personal
Diabetes Manager (PDM). Soon you will enter and change your own personal settings with confidence and ease.
The system is designed to use rapid-acting U-100 insulin. The following insulin analogs have been tested and found
to be safe for use in the Reservoir Patch of the pump: Humalog®, NovoLog®, and Apidra®. Before using a different
insulin with this pump, check the insulin drug label and your health care status to make sure it can be used with your
pump. Refer to the insulin labeling and follow your healthcare professional’s directions for how often to replace the
Patch.
Indications
The systems are indicated for the continuous subcutaneous (below the skin) delivery of insulin, at set and variable
rates, for the management of diabetes mellitus in persons requiring insulin.
Contraindications
Insulin pump therapy is NOT recommended for people with diabetes who are either:
y Unable to test their blood glucose levels at least four times per day.
y Unwilling to demonstrate adequate carbohydrate counting skills.
y Unable to maintain good diabetes self-care skills.
4
yUnwilling to see their health care professional regularly.
Successful insulin pump therapy requires sufficient vision or hearing to respond to pump alerts and alarms.
Warnings, precautions and important safety information
Warnings
yCheck with your health care provider regarding your individual training needs. Do NOT attempt to connect to
your pump before you have been trained on your pump.
yIncorrect use of your pump, failure to follow the instructions in this User Guide or improper/inadequate self-care
and troubleshooting techniques can lead to death or serious injury. If you do not understand something or have
questions, ask your health care team or call Customer Support or your local Medtrum distributor.
yYour pump is designed to deliver insulin reliably, but because your pump uses only rapid-acting insulin, you will
not have long-acting insulin in your body. To avoid the risk of diabetic ketoacidosis (DKA) or very high BG, you
must be prepared to give yourself an injection of insulin if delivery is interrupted for any reason.
yYour pump is designed and calibrated to deliver U100 insulin. Use of any insulin with lesser or greater
concentration can result in serious injury or death.
yYou must take a fingerstick test with your BG meter and use that BG value to make any insulin or treatment
decisions.
yYour pump and pump accessories include small component pie ces that could pose a choking hazard for small
children.
Precautions
yOccasionally check the infusion site for proper placement and leaks. Improperly placed infusion sites or leaks
around the infusion site can result in under infusion.
yAlways dispose of used Patches following the regulations in your community. Failure to follow these guidelines
5
may pose health hazards.
y Occasionally check that your PDM personal settings are correct.
y Occasionally check to make sure your PDM emits audible tones that are easily detectable and that the vibrate
feature is working correctly.
yYour PDM uses battery power to notify you of alerts, warnings, and alarms. If you do not confirm the notification,
your PDM will continue to use battery power as the notifications repeat and progress. This will result in reduced
battery life and the Replace Battery Alarm screen appearing sooner than expected.
yYour pump is designed only for Continuous Subcutaneous Insulin Infusion (CSII). It is not intended for use with
any other delivery substance.
y Consult your health care team before using your pump to determine which programming features are
appropriate for you. Some features require a greater knowledge of insulin pumping and advanced self-care skills.
Additionally, some advanced programming features require that testing and fine-tuning of basic settings be
completed in order to achieve the best possible results. Your health care team will give you specific training on
programming and using your pump.
yUse of Extended Bolus, Combo Bolus and Bolus calculator, all require input from your health care team. Do
NOT attempt to use these features until you have specific information for your treatment plan and have had
specific training on each programming feature.
yOnly your health care team can determine your Insulin to Carbohydrate (I:C) ratios, Insulin Sensitivity Factors
(ISFs), BG Target ranges and duration of Insulin on Board (IOB).
yBasal rates that are too high or too low can adversely affect BG levels. Work with your health care team to
fine-tune basal rates.
yThe way your body uses insulin can be affected by many things. Contact your health care team about lifestyle
changes such as starting/stopping your exercise program or significant weight loss/gain. Your basal rates may
need to be modified.
yDo NOT stop using your pump if you are ill unless instructed to do so by your health care provider. Even when
you are sick, your body still needs insulin.
yMedtrum Corporation recommends that you have someone around you (fa mily, friends, etc.) who understands
diabetes and pump therapy, so in the event of an emergency, they can help you. Be sure they are familiar with
6
any information given to you by your health care team.
y Before Bedtime
- Plan Patch changes at meals or one to two hours before bedtime. If a change is needed at bedtime, then
check BG in one to two hours. Always check BG one to two hours after Patch change.
- Always check that your Patch has enough insulin to last through the night before going to bed.
yIf you return your PDM for service and a replacement PDM is sent, Do NOT use the replacement PDM until all
the settings specific to your treatment plan have been programmed.
yIf you drop your PDM or it has been hit against something hard, inspect it to be sure it is still working properly.
Check that the display screen is working and clear, and battery cap are properly in place. Call Customer Support
or your local Medtrum distributor if you identify or suspect your PDM has been damaged.
yYour pump is designed to operate in conditions where temperatures are between 5° C (40° F) and 40° C (104°
F). If your pump is exposed to temperatures outside these parameters, extra care should be taken to protect it
from extreme temperatures.
y To avoid risk of explosion, do NOT use your pump in the presence of explosive gases.
y Your PDM is designed to achieve optimum performance and battery life with an AAA battery (1.5V). Use of
anything other than a 1.5V battery could permanently damage your PDM and voids its warranty.
yDo NOT use household cleaners, chemicals, solvents, bleach, scouring pads or sharp instruments to clean your
pump. Small amounts of alcohol can be used to clean the enclosure of your pump. Never put your pump in the
dishwasher or use very hot water to clean it.
y NEVER use a hair dryer, microwave oven or baking oven to dry your pump. Use a soft towel.
y Do NOT try to modify any part of the system. Any problems associated with the system, please contact
Customer Support or your local Medtrum distributor.
yDo NOT use anything other than the manual specified accessories, which could permanently damage your
system and voids its warranty.
yThe PDM, the Pump Base and the Wireless USB Stick co
mply with Part 15 of the FCC rules
7
This device complies with Part 15 of the FCC Rules. Its operation is subject to the following two conditions:
(1) These devices may not c
-ause harmful interference.
(2) These devices must accept any
-interference received, including interference that may cause undesired
operation.
X‐rays, MRIs and CT scans
The Patch Pump and PDM may be affected by strong radiation or magnetic fields. If you are going to have X-ray,
MRI, CT scan or other type of exposure to radiation, TAKE OFF YOUR PATCH PUMP AND PDM, and put them
outside the treatment area. Replace with a new Reservoir Patch after the test or procedure is completed.
The Product is designed to tolerate common electromagnetic and electrostatic fields, including airport security
systems and cellular phones.
Consumables
The pumps use disposable Reservoir Patches for insulin delivery.
yReservoir Patches — The pump is only used with the 200-unit Medtrum Reservoir Patches (MD-JN-002).
Change your Reservoir Patch every two to three days.
Warning: For your protection the pump has undergone extensive testing to confirm appropriate operation when used
with Reservoir Patches manufactured or distributed by Medtrum. We recommend using Medtrum Reservoir Patches
as we cannot guarantee appropriate operation if the pump is used with Reservoir Patches offered by third-parties
and therefore we are not responsible for any injury or malfunctioning of the pump that may occur in association with
such use.
About radio frequency (RF) communication
Your pump has built-in RF capability. RF is a type of wireless communication. Cell phones use RF technology, as do
many other devices. RF is how your pump and PDM communicate and share data.
RF communication between your pump and PDM will work up to a distance of about 2 meters (6.6 feet) and will
transmit through clothing. Direct line of sight is not required for RF communication. As long as you have a good RF
8
signal and are within range, you can use your PDM to control and monitor pump. Exposing your pump to water, and
certain objects in between the two devices may interfere with RF communication.
Common consumer electronic devices that transmit in the same frequency band used by the pump may prevent the
PDM from receiving the pump status information sent by the pump or transmitting control commands to the pump.
Most cellular (mobile) phones, mobile or portable handheld units, when transmitting or receiving, may cause
significant interruption of transmitter-receiver communication. It is likely that other devices operating in similar
frequency ranges will have a similar effect. This interference, however, will not cause any incorrect data to be sent or
received and will not cause any harm to your pump.
When conditions or distance cause RF communication to be lost or interrupted, you will not be able to use your PDM
to control and monitor pump status. This also means that data transfer between the two devices will stop temporarily.
The PDM is designed to sense and notify you about a lost connection. As soon as the problem is resolved, RF
communication will resume.
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:
y Quick-acting glucose tablets or gel
y BG monitoring supplies
y Urine ketone testing supplies
y Insulin syringe and fast-acting insulin (with dosage instructions from your healthcare professional)
y Extra Medtrum 2.0mL Reservoir Patch
y Extra AAA alkaline batteries
y Dressing and adhesive
y Glucagon Emergency Kit®
y Emergency contact phone numbers
9
Avoid extreme temperature
The Reservoir Patch’s operating temperature is between +10~+40°C. Under normal circumstances, your body
temperature will keep the Reservoir Patch well within this range.
Warning: Do NOT expose a Reservoir Patch to direct sunlight for long period of time. It is recommended that you
remove your Reservoir Patch prior to using hot tubs, whirlpools, or saunas. These conditions could expose the
Reservoir Patch to extreme temperature and may also affect the insulin inside the Reservoir Patch.
Note: Remember to check your blood glucose levels frequently before and after removing the Reservoir Patch.
Note: Insulin degrades at high temperature and will freeze near 0°C. So please try to avoid Reservoir Patches
exposed in extreme high or low temperature environment.
Water and your Patch
The Patch Pump is waterproof to a depth of 2.5m for 30 minutes (IPX8). After exposure to water, rinse off the Patch
Pump with clean water and gently dry it with a towel.
Warning: Th e Patch Pump may not able to delivery normally in the water. Do NOT expose your Patch Pump to water
at depths greater than 2.5m or for more than 30 minutes. Check often to make sure the Reservoir Patch and soft
cannula are securely attached and in place. If the cannula is not properly inserted, hyperglycemia may result.
Warning: The PDM is not waterproof. Do NOT place it in or near water.
Storage
Store unopened Reservoir Patches in a cool, dry place. Extreme heat or cold can damage Reservoir Patches and
cause them to malfunction.
Warning: Do NOT apply or use a Reservoir Patch if its sterile packaging is opened or damaged, as this may
increase the risk of infection. Reservoir Patches are sterile unless their packaging is opened or damaged.
10
The basics
Introduction to insulin pump therapy
In insulin pump therapy, also known as Continuous Subcutaneous Insulin Infusion (CSII) Therapy, a pump system
delivers precise doses of rapid-acting insulin through a tiny, flexible catheter called a cannula. The insulin goes into
the fatty tissue below subcutaneous tissue. You simply program your diabetes pump system to deliver it in two
different ways:
yBasal Rate: Small amounts of insulin delivered continuously day and night to cover your body’s normal insulin
needs (not including food). The programmed rate is determined by your healthcare professional
yBolus Dose: Additional insulin you can deliver “on demand” to cover meals or snacks, or to help bring down
high blood glucose. Insulin pumps have bolus calculators that help you calculate your bolus amount based on
settings that are determined by your healthcare professional.
How does the system work?
yThe Patch Pump is a small, lightweight, self-adhesive device worn directly on your body to deliver precise,
personalized doses of insulin into your body through a small flexible tube (called a cannula). The Patch Pump is
composed of two parts: the reusable Pump Base (MD-JN-001) and the disposable Reservoir Patch
(MD-JN-002). The reusable Pump Base stores all your pump settings for precise 24-hour basal and bolus
delivery . The Pump Base holds the electronics, memory, and a buzzer just in a smaller package! The disposable
200 unit insulin Reservoir Patch should be replaced every 2 or 3 days. The Reservoir Patch is more
sophisticated than the standard insulin cartridge, because it incorporates the precision dispensing screw,
plunger, driver, cannula, inserter and even a battery to power your Pump Base. The delivery system in the
Reservoir Patch is the broader applied part in the Patch Pump.
11
9 Reservoir Patch 9 Pump Base
y The Personal Diabetes Manager (PDM) (MD-FM-006P) is the “brains” of the operation. All Patch Pump
operations are programmed and controlled through the palm-sized PDM. The PDM allows you to program the
Patch Pump with your personalized insulin delivery instructions just like any traditional pump. But instead of
being connected to the pump, it wirelessly monitors the Patch Pump’s operation, and wirelessly downloads all
the information to the Patch Pump so it can continue to deliver insulin based on your personalized settings even
if the PDM is not within reach!
Note: When conditions or distance cause RF communication to be lost or interrupted, you will not be able to use your
PDM to control and monitor pump status. This also means that data transfer between the two devices will stop
temporarily. The Patch pump can continue to deliver insulin based on your personalized settings which have been
sent by the PDM before RF communication is lost or interrupted. The patch pump has built-in safety feature: It can
check its own functions and automatically stop delivery when serious conditions happen. To make you aware of a
serious condition, the patch pump will automatically sounds an alarm. The PDM is designed to sense and notify you
about a lost connection. As soon as the problem is resolved, RF communication will resume.
12
9
y
r
e
b
e
U
e
w
o
n
y
t
c
a
-
m
e
s
a
i
m
m
Y
e
n
e
n
P
a
G
k
s
a
u
m
u
c
n
r
n
m
e
s
u
r
m
a
n
Personal Diab
tes manager (P
DM)
The Wireless
y
accessory to th
USB port and
Management S
therapy . You ca
9
Wireless USB
Ke
features
The
PatchTrum Insu
sma
ll and slim size,
No
tubing
SB Stick (MD
Insulin Manage
irelessly downlo
ftware. The Wir
refer to the “Da
Stick
lin Management
hus providing di
FM-007) acco
ent System. It i
ads the system
less USB Stick
ta Management
System (MD-S
creetness. Plus
panied by the
s a radio freque
data from your
ay benefit you
Software User
-007) combines
you’ll enjoy the
Data Manage
cy (RF) device t
DM, and then
nd your health
uide” for more i
ey features of t
afety, convenie
ent Software i
hat plugs into yo
ploads the data
are team in you
formation.
aditional insulin
ce, and freedo
an optional
r computer’s
to your Data
insulin pump
pumps with a
of:
The
e is no tubing
und
r your clothes.
bub
les. In many w
onnecting the P
Tubing of tradit
ys, it can feel l
tch Pump to th
onal pumps ca
ike a leash. Th
PDM. You we
get twisted, p
study has dem
13
r the Patch Pu
lled out by acci
onstrated the b
p comfortably
dent, kinked or
nefits of a tubi
nd discreetly
filled with air
g-free insulin
pump, which can help patients overcome their fear of insertion sets or unsightly tubing and achieve the clinical
benefits of insulin pump therapy.
In addition, you can carry the PDM separately in a backpack, briefcase, or purse.
Automated cannula insertion
With the insulin management system, you don’t have to insert the infusion set manually or carry around a separate
inserter. You simply press a button on the PDM and the Patch Pump automated insertion system safely and
consistently inserts the cannula beneath the skin, virtually pain free.
A fully‐integrated design
The Patch Pump integrates the pumping mechanism, cannula, needle, and insulin reservoir into one wearable u nit.
There is no need to carry separate reservoirs, infusion sets, or inserters, and no assembly required. Just add insulin
and it’s ready to go.
Bolus guide
After you check your blood glucose, enter the carbs for your snack or meal. Based on your individual settings, the
PatchTrum Insulin Management system contains an optional feature called the Bolus Guide. This does the math for
the required bolus amount based on your personal settings. The system displays a suggested bolus dose. You can
accept the suggestion, change it, or cancel it. The Bolus Guide will use your BG reading, carbohydrate intake, and
active insulin when coming up with your bolus amount.
Record keeping
Another convenient part of the PatchTrum insulin management system is record keeping. The data storage system in
the personal diabetes manager (PDM) displays up to 90 days’ worth of information. This includes basal rates, bolus
doses, daily totals, alarms and events. Records wrote in the memory chip of the PDM can be stored up to 10 years.
14
Loading...
+ 34 hidden pages
You need points to download manuals.
1 point = 1 manual.
You can buy points or you can get point for every manual you upload.