MEDTRUM TECHNOLOGIES FM006, JN001 User Manual

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MEDTRUM PRODUCT
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chTrum
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SY007
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Medtrum Tech
Unit 7F, Buildin
Shanghai 2012
China
Te l+8621‐5 Fax+8621‐5
www.medtru
ologies Inc.
g 8, No.200 Niud
3
274781
274779
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Contents
Contents ............................................................................................................................................................................... 1
Introduction ......................................................................................................................................................................... 4
Before you begin ...........................................................................................................................................................4
Indications ....................................................................................................................................................................4
Contraindications ..........................................................................................................................................................4
Warnings, precautions and important safety information ..............................................................................................5
Warnings .......................................................................................................................................................................... 5
Precautions ...................................................................................................................................................................... 5
Xrays, MRIs and CT scans ................................................................................................................................................ 8
Consumables .................................................................................................................................................................... 8
About radio frequency (RF) communication ................................................................................................................... 8
Emergency kit .................................................................................................................................................................. 9
Avoid extreme temperature .......................................................................................................................................... 10
Water and your Patch .................................................................................................................................................... 10
Storage ........................................................................................................................................................................... 10
The basics ........................................................................................................................................................................... 11
Introduction to insulin pump therapy .......................................................................................................................... 11
How does the system work? ........................................................................................................................................ 11
Key features ................................................................................................................................................................ 13
No tubing ....................................................................................................................................................................... 13
Automated cannula insertion ........................................................................................................................................ 14
A fullyintegrated design ................................................................................................................................................ 14
Bolus guide..................................................................................................................................................................... 14
Record keeping .............................................................................................................................................................. 14
Event capturing .............................................................................................................................................................. 15
The personal diabetes manager (PDM) ........................................................................................................................ 16
Install battery ................................................................................................................................................................. 16
Buttons ........................................................................................................................................................................... 18
LCD screen ..................................................................................................................................................................... 19
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HOME screen ................................................................................................................................................................. 19
Screen icons ................................................................................................................................................................... 20
Battery ................................................................................................................................................................... 20
Time ....................................................................................................................................................................... 20
Silence icon ............................................................................................................................................................ 21
Reservoir volume ................................................................................................................................................... 21
Alert and alarm icons ............................................................................................................................................. 21
RF signal icon ......................................................................................................................................................... 21
Scroll bar ........................................................................................................................................................................ 22
Screen backlight ............................................................................................................................................................. 22
Beep/vibrate .................................................................................................................................................................. 22
Menus ............................................................................................................................................................................ 23
MAIN MENU ........................................................................................................................................................... 23
BOLUS MENU ......................................................................................................................................................... 23
SUSPEND ................................................................................................................................................................ 23
BASAL MENU .......................................................................................................................................................... 24
PATCH MENU .......................................................................................................................................................... 24
UTILITIES MENU ..................................................................................................................................................... 24
HISTORY MENU ...................................................................................................................................................... 25
STATUS screen ................................................................................................................................................................ 25
EVENT screen ................................................................................................................................................................. 26
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
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Appendix I: Symbols and icons ............................................................................................................................................ 47
Product label symbols ................................................................................................................................................. 47
PDM icons ................................................................................................................................................................... 48
3
Introduction
Before you begin
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.
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y Unwilling 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
y Check 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.
y Incorrect 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.
y Your 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.
y Your 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.
y You must take a fingerstick test with your BG meter and use that BG value to make any insulin or treatment
decisions.
y Your pump and pump accessories include small component pie ces that could pose a choking hazard for small
children.
Precautions
y Occasionally check the infusion site for proper placement and leaks. Improperly placed infusion sites or leaks
around the infusion site can result in under infusion.
y Always dispose of used Patches following the regulations in your community. Failure to follow these guidelines
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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.
y Your 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.
y Your 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.
y Use 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.
y Only 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).
y Basal rates that are too high or too low can adversely affect BG levels. Work with your health care team to
fine-tune basal rates.
y The 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.
y Do 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.
y Medtrum 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
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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.
y If 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.
y If 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.
y Your 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.
y Do 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.
y Do NOT use anything other than the manual specified accessories, which could permanently damage your
system and voids its warranty.
y The PDM, the Pump Base and the Wireless USB Stick co
mply with Part 15 of the FCC rules
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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.
Xrays, 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.
y Reservoir 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
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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
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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.
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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:
y Basal 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
y Bolus 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?
y The 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.
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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.
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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 fullyintegrated 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.
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