Medtrum TouchCare Insulin Pump System User Guide

TouchCare Insulin Pump System

Medtrum Insulin Pump System

The Medtrum Insulin Pump System is a comprehensive insulin management system designed for people living with diabetes. It consists of a Personal Diabetes Manager (PDM), a Pump Base, and
Reservoir Patches. The system allows users to customize their insulin delivery through various settings and features.

Personal Diabetes Manager (PDM)

The PDM is the central control unit of the system. It allows users to set basal and bolus rates, start new patches, calculate bolus doses, and monitor insulin delivery. It has a 2.8-inch color touchscreen display and comes with a rechargeable battery.

Pump Base

The Pump Base securely attaches to the Reservoir Patch and delivers insulin according to the user’s settings. It has an indicator light that shows the status of the device, and it communicates with the PDM through Bluetooth technology.

Reservoir Patch

The Reservoir Patch is where the insulin is stored before it is delivered. It comes in different sizes to accommodate different insulin needs. It has a fill port where insulin is injected, and it securely attaches to the Pump Base.

Product Usage Instructions

Before using the Medtrum Insulin Pump System, please read the user manual carefully. Always consult with your healthcare provider for guidance on insulin usage.

Starting a New Patch

1. Select the infusion site for the Reservoir Patch.
2. Prepare the infusion site by cleaning it with alcohol and allowing it to dry completely.
3. Connect the Pump Base and Reservoir Patch by gently inserting the Pump Base and pushing it down until it is locked in place on the Reservoir Patch.
4. Fill the Reservoir Patch with insulin according to your healthcare provider’s instructions. Do not inject air into the fill port.

Setting Basal Rates

1. Access the Basal Setup menu in the PDM Settings.
2. Select a Basal Pattern and tap Edit Basal to set the basal rate for each segment of the pattern.
3. Review all segments and tap to save the settings.

Setting Bolus Rates

1. Access the Bolus Setup menu in the PDM Settings.
2. Set the Max Bolus rate and set up the Bolus Calculator according to your insulin needs.
3. Select Normal, Extended, or Combo Bolus as needed.

Other Features

The PDM also allows users to set audio and display options, suspend and resume insulin delivery, manually bolus insulin doses, and deactivate patches. Please refer to the user manual for detailed instructions on these features.

Insulin Pump System Overview

The Personal Diabetes Manager (PDM)

1. Power button
2. Home Key (Software Key)
3. Charging Port
4. Sound Hole
5. Indicator light

Pump Base

Reservoir Patch

• Your ultra-thin Patch Pump is composed of a reusable Pump Base (MD0401) and a disposable Reservoir Patch (MD0400) which stores up to 400 U of insulin and lasts for up to 3 days.

• The Pump Base stores delivery settings and sends data to the PDM via Bluetooth Low
  Energy(communication range 4 meters without blocking).

• The Patch Pump (Base and Patch connected) is waterproof at 8 feet (2.5 meters) for 60 minutes (IP28).

• Store the Pump Base and Reservoir Patch at temperatures between 14°F (-10°C ) and 131°F (55°C).

Charge PDM
The PDM requires an AC adapter with an output of DC 5.0V

PDM Settings

1. Turn on/off the PDM

   • Turn-on – Long-press the power button, a green light will flash.
   • Turn-off – Long-press the power button for about 2 seconds, then slide to power off. Or long-press the power button for about 8 seconds.

2. Wake the PDM
   When the screen goes black, press the power button and then slide to unlock

3. Select language and country

4. Set time and date
   Note: You can only change the date and time when there is no activated Reservoir Patch.

5. Bolus Calculator

6. Set audio options
   Main Menu , Settings  ,General,  Audio Options
   If you set the audio option to Audio off /Vibrate off, your PDM only vibrates when a serious Alarm occurs.

7. Set display settings
   Main Menu → Settings →  General → Display
   It is recommended for new users to set backlight time as 2 minutes

8. Find Pump Base SN
   You can find the Pump Base SN on the product box or on the back of the Pump Base.

9. Enter Pump Base SN
   Main Menu → Patch → Pump Base SN
   Tap —— to enter SN manually

Basal Settings

Main Menu  Settings  Insulin Pump  Basal Setup

1. Max Basal
   Tap the Max Basal rate to edit it

2. Edit Basal Pattern

3. Tap Edit Basal, then select the Pattern to edit it

4. Set basal rate

  * Tap blue U/H field to set the Basal rate.
  * You can set a basal rate between 0 and the Max Basal Rate with an increment of 0.05 U/H.  

3. Add Time Segment
  *         * Tap +Add Time Segment to add a new segment.
    * You can set up to 48 segments for each day.
4. Delete Time Segment
  * Slide to left on each segment, tap Delete. The start time of next segment will be adjusted
  * Slide on segment back to right to cancel deleting  

Note: Recheck all the numbers you entered to  make sure that they are the intended values.

5. Scroll up and down to review all segments
6. Tap to save the settings

3. Select a Basal Pattern

Main Menu → Settings →  Insulin Pump →  Bolus Setup

1. Max Bolus
   Tap the Max Bolus to edit it

2. Set up the Bolus Calculator

   • Turn on/off the Bolus Calculator
   • Set IC ratios
   • Set Insulin Sensitivity
   • Set BG target
   • Set IOB Time (Active Insulin Time)

3. Normal, Extended and Combo Bolus

Start a new Patch

1. Select the infusion site

   • Clean, less hair, no sweat, uncovered, enough fat (at least 0.2 in thick), away from navel.
   • A new infusion site should be at least 1 inch (2.5 cm) away from the last site.
   • If you choose an infusion site on your abdomen, back or buttocks, apply the Patch horizontally.
   • If you choose an infusion site on your upper arm or thigh, apply the Patch vertically.  Note: Please pay attention to the location of the Sensor site and Patch site so that there is little communication interruption.

2. Prepare the infusion site

   •   * Wash your hands with soap and water.

   • Clean the infusion site with an alcohol wipe to enhance adhesion.
   • Let the skin air dry completely.

3. Connect Pump Base and Reservoir Patch
   Main Menu → Patch → New Patch
   Gently insert the pump base and push down all the way until the pump base is locked in place to the reservoir patch. The pump beeps four times

4. Fill the New Reservoir Patch
   With the help of your healthcare provider, decide on the amount of insulin (70 U – 400 U) you need to insert into the Reservoir Patch.
   Warning: Do not inject air into the fill port. Doing so may result in unintended or interrupted insulin during.

5. Push air into the vial.

6. Fill the syringe with insulin. Remove air

7. Keep the syringe vertical to the Patch
   Pump, and the needle inside the fill port.
   Retract the plunger to remove air bubbles

8. Push the plunger until you see a drop of insulin at the tip of the needle

9. Slowly fill the Reservoir with insulin

10. Prime the Pump Press needle button
    Do not start priming before the needle button is pressed

11. Place the Patch

12. Remove the safety lock

13. Peel off the adhesive liners

14. Press the Pump against the skin

15. Run your finger around the entire edge of the adhesive
    

16. Press the needle button with one quick motion to completely insert the needle

17. Start Insulin Delivery

Read Pump

Home Screen

1. Insulin Delivery Status
2. IOB
3. Delivery details
4. Pump RF Signal
5. Remaining insulin in Reservoir
6. Alarm/Alert

Pump Status
Slide on the Home Screen from left to right to go to status screen

Main Menu
Slide on the Home Screen from right to left to go to main menu

History
Main Menu → History

Delivery Status

Temp Basal

Activate a Temp Basal
Main Menu → Basal → Temp Basal
With a Temp Basal you can adjust your Basal rate for a short time
Select a Basal type, rate or percent and duration Cancel a Temp Basal
Main Menu → Basal → Cancel Temp Basal

Set Preset Temp Basal
Main Menu → Settings → Insulin Pump → Basal Setup → Preset Temp Setup Activate a Preset Temp Basal
Main Menu → Basal → Preset Temp Basal

Manual Bolus

1. Main Menu → Bolus → Manual bolus
2. Set Bolus dose
3. Set Bolus type
4. Slide to deliver

Food Bolus Calculator

1. Main Menu→ Bolus → Bolus Calculator
2. Enter BG or Carb,  or both
3. Set Bolus dose and Bolus type
4. Slide to deliver

Suspend & Resume

Resume
Main Menu → Resume

Deactivate the Patch

1. Deactivate the Patch
   Menu → Patch → Deactivate Patch

2. Remove the Patch

   • After the Reservoir Patch is deactivated, retract the needle with the needle-eject tool.
   • Gently remove the entire Patch Pump. Use a medical adhesive remover or baby oil if necessary.
   • Fold and break the tab of Reservoir Patch. Push up the pump base from the bottom and remove it from the old Reservoir Patch.
   • Discard the old Reservoir Patch according to your local waste disposal regulations. Do NOT discard your Pump Base. It is reusable.

Warning: Once the Patch is removed from the skin, do not attempt to press the needle button again. Doing so will result in injury.

Alerts & Emergency Kit

Alert

necessary.

LOW RESERVOIR| Change Patch soon.
PATCH EXP IN 1

HOUR

| Change Patch soon.
PATCH BATTERY

LOW

| Change Reservoir Patch soon.

Alarm (Medium Priority)

PDM Message                   Actions to Take

PATCH EXPIRED        Change Patch. Check blood glucose.
EMPTY RESERVOIR     Change Patch. Check blood glucose.
EXCEEDS MAX TDD    Change Patch. Check blood glucose.

Check history.

PUMP OUT OF            Move PDM close to Pump. If failed to RANGE recover Pump signal, please change

Patch.

PUMP RESTARTED     Patch changed? For help call the CC.

Alarm (High Priority)

PDM Message Actions to Take

• OCCLUSION DETECTED: Change Patch. Check blood glucose.
• PATCH ERROR: Change Patch. Check blood glucose.
• PUMP BASE ERROR: Remove Pump. Contact customer support Check blood glucose

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 4.0 mL Reservoir Patches
• Power Bank
• 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
• If traveling, a copy of a letter from your healthcare provider for airline security

Your Personal Settings

Max Basal Rate: ____ U/H

Basal Pattern Name: __

Start Time| Rate (U/H)| Start Time| Rate (U/H)
：| | ：|
：| | ：|
：| | ：|
：| | ：|
：| | ：|
：| | ：|
：| | ：|
Basal Pattern Name: __

Start Time| Rate (U/H)| Start Time| Rate (U/H)
：| | ：|
：| | ：|
：| | ：|
：| | ：|
：| | ：|
：| | ：|
：| | ：|
Name| Rate| Duration
---|---|---
Heavy Exercise| % or

U/H

| ：
Medium Exercise| % or

U/H

| ：
Light Exercise| % or

U/H

| ：
Sick| % or

U/H

| ：
Temp 1| % or

U/H

| ：
M Temp 2| % or

U/H

| ：
| |
I:C Ratio

Start Time| I:C (g Carb)
：| 1 U : g
：| 1 U : g
：| 1 U : g
：| 1 U : g
：| 1 U : g
：| 1 U : g
：| 1 U : __ g
BG Target (mg/dL)

Start Time| Low Limit| High Limit
：| |
：| |
：| |
：| |
：| |
：| |
：| |
Insulin Sensitivity

Start Time| ISF (mg/dL)
：| 1 U : mg/dL
：| 1 U : mg/dL
：| 1 U : mg/dL
：| 1 U : mg/dL
：| 1 U : mg/dL
：| 1 U : mg/dL
：| 1 U : __ mg/dL

Max Bolus: __U
Active Insulin Time: :

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. his 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.

Medtrum Technologies Inc.
7F, Building 8, No. 200, Niudun Road Shanghai 201203, China
Tel: +86-21-50274781
Fax: +86-21-50274779

Medtrum B.V.
Nijverheidsweg 17
5683 CJ Best
The Netherlands
Tel: +31(0) 499745037

This product complies with Directive 93/42/EEC (MDD) and Directive 2014/53/EU (RED).

SY-401
IM882401US-001
Version:1.00

Email: www.medtrum.com

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