THEE MEDTRUM PRODUCT PatchTrum Insullin M ana agemen nt System m MD D‐SY‐007 Use er Guide Medtrum Techn nologies Inc. Unit 7F, Building 8, No.200 Niudu un Road Shanghai 20120 03 China Tel：+86‐21‐50 0274781 Fax：+86‐21‐50 0274779 www.medtrum m.
Contents Contents ............................................................................................................................................................................... 1 Introduction ......................................................................................................................................................................... 4 Before you begin ..................................................................................................................
HOME screen ................................................................................................................................................................. 19 Screen icons ................................................................................................................................................................... 20 Battery ...................................................................................................................................................
Appendix I: Symbols and icons ............................................................................................................................................ 47 Product label symbols ................................................................................................................................................. 47 PDM icons .............................................................................................................................................................
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.
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.
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.
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.
This device complies with Part 15 of the FCC Rules. Its operation is subject to the following two conditions: -(1) These devices may not cause 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.
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.
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.
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.
9 y Reservoir Patch 9 Pump Base 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.
9 y Personal Diabe etes manager (PDM) The Wireless USB U Stick (MD--FM-007) accom mpanied by the Data Managem ment Software is s an optional accessory to the e Insulin Managem ment System. It is a radio frequen ncy (RF) device that plugs into you ur computer’s USB port and wirelessly w downloads the system data from your PDM, P and then uploads u the data to your Data Management So oftware. The Wire eless USB Stick may m benefit you and a your health care c team in yourr insulin pump therapy.
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.
Event capturing The PatchTrum Insulin Management System contains the options you use to enter information about different events into the system. Examples of events include: blood glucose, meal, insulin, health, and activity information. This information can help you and your diabetes management team make better decisions about your diabetes management plan. These events can be reviewed later with the Medtrum Data Management Software.
The personal diabetes manager (PDM) Install battery The PDM is designed to only accept a new AAA battery. Note: Do NOT use any other type of batteries than AAA alkaline batteries to power the PDM. Never use old or used batteries; the PDM may not work properly. As a safety measure, if you install a battery that does not have full power, the WEAK BATTERY or FAILED BATT TEST alarm may sound. If you receive a WEAK BATTERY alarm, respond to the alarm and continue.
3. Remove the old battery and dispose of it per the disposable requirements of your state or country. Put the new battery in the PDM. Check the diagram inside the compartment to make sure the battery is inserted correctly. Note: Do NOT use batteries that have been in cold storage, such as in the refrigerator or in your car during winter in cold climates. 4. Replace the battery door by pushing the compartment latch along with the direction of arrow. 5. Turn the PDM face-up.
Buttons Buttons and its names Names of Buttons Functional description (From the STATUS screen) UP Scrolls up the items in a list. DOWN Scrolls down items in a list. OK Opens the MAIN MENU. ESC Opens the HOME screen. B/S Turn the backlight on when viewing screens other than the HOME screen (hold down B/S and press DOWN).
Names of Buttons Functional description (From the menus and programming screen) UP y y Increases the value of an item. Scrolls up the items in a list. DOWN y y Decreases the value of an item. Scrolls down the items in a list. OK ESC B/S Accepts a selected menu item or activates a selected setting. y Returns to previous screen. y Cancels settings if the OK button has not been press yet. y Press simultaneously with DOWN button to turn on/off backlight.
Screen icons Battery The battery icon displays the level of battery power remaining. There are four segments in the icon. If you only have one segment left, make sure you have a new battery available. At least 60% left Low battery Time The current time of day is displayed across the top of the LCD screen in the format you select 12 – hour or 24 – hour. The AM or PM is only displayed for the 12 – hour format.
Silence icon The Silence icon ( ) is displayed at the top of the LCD screen only when the audio alert/alarm is turned off. Reservoir volume The reservoir volume icon displays the current amount of insulin in the Reservoir Patch. The icon is divided into four segments.
Patch Pump is active but RF communication is lost or interrupted Scroll bar If there is more text than the screen can show, a scroll bar appears in the right side of the screen. Press UP/DOWN button view any additional text. Screen backlight When you press DOWN button from the HOME screen, the light on the screen turns on or off. Under other screen displays, the backlight can be turned on/off by the pressing B/S button and the DOWN button together.
Menus MAIN MENU The MAIN MENU lists all the major menus. The MAIN MENU is the highest level menu. There are submenus, functions, status and programming screens in the lower menu levels. Press OK button from the HOME screen to open the MAIN MENU. The MAIN MENU consists of six submenus: Bolus, Suspend, History, Basal, Reservoir Patch and Utilities. BOLUS MENU This menu contains the settings and function for bolus deliveries.
BASAL MENU Contains the functions to setup and deliver your basal insulin. Refer to chapter “How to use the PDM?” and chapter “Using patch advanced features” for more information. PATCH MENU Contains the functions to change your Reservoir Patch and set your Pump Base ID. Refer to chapter “How to use the Reservoir Patch and Pump Base?” for more information. UTILITIES MENU Contains the functions to setup basic parameters and basic safety information for your system and self-test.
HISTORY MENU History menu is used to review insulin delivery, alarm history and event history. Refer to section “History feature” in chapter “How to use the PDM” for more information. STATUS screen The STATUS screen lists the System’s current operating status. Only check your pump status (press ESC) when you are not programming your PDM. If you press ESC during programming, you will cancel the settings you are trying to enter. Press ESC from the HOME screen to open the STATUS screen.
EVENT screen The Event screen allows you to enter information about different events into the system. Examples of events include: blood glucose, meal, insulin, health, and activity information. Refer to section “Event journal” in chapter “How to use the PDM?” for more information.
Using the Patch Pump How to change a new Patch? The Reservoir Patch requires replacement and is not to be reused. The Reservoir Patch should be replaced approximately every 2-3 days or as directed by your health care team. Refer to the insulin labeling and follow the direction of your health care team for frequency of replacing the Reservoir Patch. If you like, you can set the PDM to notify you when it is time to replace the Reservoir Patch.
y Do NOT apply or use a Reservoir Patch if it is damaged in any way. A damaged Reservoir Patch may not work properly. To minimize the possibility of site infection, do NOT apply a Reservoir Patch without first using aseptic technique. y Do NOT use a Reservoir Patch if you are sensitive to or have allergies to acrylic adhesives or have fragile or easily damaged skin. y Do NOT apply a new Reservoir Patch until you have deactivated and removed the old Reservoir Patch.
Prepare your Patch Pump for use When you are done practicing and ready to use your pump with insulin, you must make sure the time and date are correct on your pump. You must also program your settings as instructed by your healthcare professional. You will need these items before you begin: - Vial of rapid-acting U-100 insulin Warning: NEVER use insulin that is cloudy, it may be old or inactive.
Deactivate the current Reservoir Patch If there is an active Reservoir Patch, you can deactivate it by Deactivate Patch menu. 1. Enter the MAIN MENU, press UP/DOWN to choose Reservoir Patch and press OK. 2. Select Deactivate Patch and press OK. 3. Select “Yes”, and then press OK. 4. Press OK to deactivate the current Reservoir Patch.
5. Several seconds later, you will see the message reminding you that the Patch has been deactivated. 6. The Reservoir Patch has been successfully deactivated. Gently lift the edge of the adhesive tape from your skin and remove the entire Reservoir Patch. Tips: Removing the Reservoir Patch slowly will help you to avoid possible skin irritation. Use soap and water to remove any adhesive that remains on the skin or, if necessary, use an adhesive remover.
Note: The change/new patch process also can deactivate the current Reservoir Patch. 1. Select Change/New Patch and press OK. If you haven’t set the Pump Base ID, you will see the following message. If you have set the Pump Base ID, you will see the following message if there is no active Reservoir Patch. 2. If there is an active Reservoir Patch, you will see the following message.
3. Press OK to deactivate the current Reservoir Patch. 4. Several seconds later, you will see the following message. 5. Remove the old Reservoir Patch, then press OK to continue. Connect the Pump Base to a new Patch 1. Connect the Pump Base to a new Reservoir Patch.
2. The PDM will beep and/or vibrate, and you will see the following message. Fill the new Patch Warning: Using cold insulin can cause air bubbles in the reservoir. If your insulin is stored in the refrigerator, wait till the insulin reaches room temperature before you fill your reservoir. When filling the reservoir, take care to remove air bubbles. 1. Swab vial with alcohol. 2. Securely twist the fill needle onto the syringe.
3. Pull outward to remove the protective cap from the needle. Save the cap, you will need it later. Warning: Use with care after removing the needle cap and exposing the fill needle. 4. Determine the amount of insulin you need to insert into the Reservoir Patch. Your healthcare professional will help you determine the correct amount. Note: The reservoir requires a minimum of 70 units of insulin to begin operation. The Reservoir Patch can deliver up to 200 units of insulin. 5.
Warning: Avoid using insulin from more than one vial, which may introduce air into the syringe. 8. With the vial down, hold the syringe. Pull straight up to remove the syringe needle from the vial, and then insert it straight down into the insulin fill port on the underside of the Reservoir Patch. Warning: To ensure proper fill, do NOT insert fill syringe at an angle into the fill port. Warning: Only use specified needle and syringe. 9.
14. After you fill the Reservoir Patch, the reservoir volume icon will change from empty to full, and then press OK. Note: The reservoir volume icon will change to full if you have filled the Reservoir Patch with at least 70 units of insulin. If you have filled the Reservoir Patch with more than 70 units and the reservoir volume icon is empty, call Customer Care. 15. The system automatically primes the Reservoir Patch.
Adult/youth Toddler For the Reservoir Patch to work best, apply it: crosswise or at a slight angle on your abdomen; hip or upper back; up and down or at a slight angle on your upper arm or thigh. You may wish to attach the Reservoir Patch: - On the abdomen. The abdomen has ample flat surface area, and is accessible and comfortable location. Insulin absorption is fast, predictable, and less affected by exercise when administrated through the abdomen.
- The belt line or waistline, or other areas where clothing may rub or constrict. - Areas with excessive hair. You may shave the area to help the Reservoir Patch attach to your skin. - Areas that are curved or rigid due to muscle or bone. - Areas within a 1-inch circle around the belly button or surgical scars. - Skin that is tender, bruised, red, or hard or has any skin disease or infection. Clean the area where you will attach the Reservoir Patch with an alcohol swab.
Attach the new Patch 1. With one hand hold the Reservoir Patch and pull the needle cap with the other hand. Pull the needle cap in a quick, straight direction up and away from the Reservoir Patch. Note: When you remove the needle cap, you will see drops formed at the tip of the needle. 2. Lift the adhesive tab and completely peel off the adhesive liner from the bottom of the Reservoir Patch. Removing the liner exposes the adhesive. 3. Do NOT touch the adhesive surface.
6. Hold your Reservoir Patch in place for 5-10 seconds. Run you finger around the entire edge of the adhesive pad to make sure it is attached to your body. Note: The Reservoir Patch’s adhesive keeps it securely in place for up to 3days. However, if necessary, several products are available to enhance adhesion. Ask your healthcare professional about these products. Avoid getting body lotion, creams, or oil near the infusion site, these products may loosen the adhesive.
Warning: Check the infusion site and cannula through the viewing window after insertion to ensure that the cannula was properly inserted. If the cannula is not properly inserted, hyperglycemia may result. Check frequently to make sure the Reservoir Patch and soft cannula are securely attached and firmly in place. Replace the Reservoir Patch if the tape becomes loose, or if the soft cannula becomes fully or partially dislodged from the skin.
Pump safety system and alarms Safety system When you turn on the personal diabetes manager (PDM), the system automatically performs a serious of safety checks. To make you aware of a condition that is outside normal pump activity or potentially serious condition, the system sounds an alert or an alarm and displays an on-screen message. The message has instruction for taking care of the alert or alarm condition. Alert or alarm conditions are easy to handle.
Alarm level Condition Message Cause ! ! PATCH ERROR Alarm Patch Error Alarm Exceeds Max TDD Alarm Exceeds Max 1 HR Delivery Alarm Pump Base Error Alarm Empty Reservoir Insulin delivery stopped, change patch now. ESC,OK to clear Detect unexpected Patch error. ! ! EXCEEDS MAX TDD Exceeds max TDD, no delivery. ESC,OK to clear Exceeds max TDD. ! ! EXCEEDS MAX 1 HR DELIVERY Exceeds max 1 hour MAX, no delivery. ESC,OK to clear Exceeds max 1 hr delivery.
Alarm level Condition Message ! STUCK KEY Alert Stuck Key Key pressed for more than 3 minutes. ESC,OK to clear End of Suspend ! END OF SUSPEND Alert Alert Low Reservoir Stopped at []. ESC,OK to clear Cause Key pressed for more than 3 minutes. Pump suspended manually or automatically. ! LOW RESERVOIR [] U or less left [] hours remaining, replace patch soon. ESC,OK to clear ! AUTO OFF ADVISORY Alert Auto Off Advisory Escalates to Auto-Off alarm if not cleared within 15 minutes.
Alarm level Alert Condition BATT Limit Out Message ! BATT OUT LIMIT Battery change too slow. ESC,OK to clear 46 Cause The battery has been out of the PDM for more than five minutes.
Appendix I: Symbols and icons Product label symbols Symbol Meaning Symbol Meaning Lot number Do NOT use if package is damaged Date of manufacture (year - month) Sterilized using ethylene oxide Manufacture Follow instructions for use Use by: (year - month) Prescription drug Caution: See Instructions for use Waterproof to 2.
Symbol Meaning Symbol Meaning Do NOT reuse Type BF equipment (Protection from electrical shock) Do NOT re-sterilize Authorized representative in the European Community PDM icons Icon Meaning Icon Meaning Insulin left Alarm Alert Audio Off Time display RF signal Battery 48
