FCC ID: 2AARU-FM018 PDM

Contents Insulin Pump System Overview PDM Settings Basal Settings Bolus Settings Start a new Patch Read Pump Temp Basal Manual Bolus Food Bolus Calculator Suspend & Resume Deactivate the Patch Alerts & Emergency Kit Your Personal Settings

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. Medtrum Simplifying Diabetes 1 2 4 5 6 9 10 11 12 13 14 15 16 The Personal Diabetes Manager (PDM) Pump Base Reservoir Patch Insulin Pump System Overview 5 4 1 2 3 1. Power button 2. Home Key (Software Key) 3. Charging Port 4. Sound Hole 5. Indicator light Your ultra-thin Patch Pump is composed of a reusable Pump Base (MD0201) and a disposable Reservoir Patch

(MD0200) which stores up to 200 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 -10C (14F) and 55C(131F). Charge PDM The PDM requires an AC adapter with an output of DC 5.0V

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. Fully charged Charging Not charging Battery low Battery empty Medtrum Simplifying Diabetes 1 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

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. 4. Set time and date Note: You can only change the date and time when there is no activated Reservoir Patch. 5. Bolus Calculator Refer to Page 5 2 Medtrum Simplifying Diabetes 6. Set audio options 8. Find Pump Base SN 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. You can find the Pump Base SN on the product box or on the back of the Pump Base. PDM Settings 7. Set display settings 9. Enter Pump Base SN Main Menu Settings General Display Main Menu Patch Pump Base SN It is recommended for new users to set backlight time as 2 minutes Tap ------ to enter SN manually

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. Medtrum Simplifying Diabetes 3 Main Menu Settings Insulin Pump Basal Setup Basal Settings 1. Max Basal Tap the Max Basal rate to edit it 2. Edit Basal Pattern 1. Tap Edit Basal, then select the Pattern to edit it 2. 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

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. 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 5. Scroll up and down to review all segments 6. Tap to save the settings Note: Recheck all the numbers you entered to make sure that they are the intended values. 3. Select a Basal Pattern Main Menu Basal Select Pattern 4 Medtrum Simplifying Diabetes 24 Hour Total 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 Bolus Settings

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. Medtrum Simplifying Diabetes 5 Start a new Patch 1 Select the infusion site Clean, less hair, no sweat, uncovered, enough fat

(at least 5mm thick), away from navel. A new infusion site should be at least 2.5 cm (1 inch) 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. 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

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. Insert the hooks and connecter on the Reservoir Patch all the way into the slots of the Pump Base. 6 Medtrum Simplifying Diabetes Note: Please pay attention to the location of the Sensor site and Patch site so that there is little communication interruption. The pump will beeps four times 5 Fill the New Reservoir Patch With the help of your healthcare provider, decide on the amount of insulin (70 U - 200 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 delivery. 1. Push air into the vial. 2. Fill the syringe with insulin. Start a new Patch 4. Push the plunger until you see a drop of insulin at the tip of the needle 6 Prime the Pump Remove air 3. Keep the syringe vertical to the Patch Pump, and the needle inside the fill port. Retract the plunger to remove air bubbles. 5. Slowly fill the Reservoir with insulin Press needle button Do not start priming before the needle button is pressed. m o c m u r t d e m w w w

. Medtrum Simplifying Diabetes 7 Start a new Patch Priming takes about 3 minutes. 7 Place the Patch 1. Remove the safety lock 2. Peel off the adhesive liners 3. Press the Pump against 4. Run your finger around the the skin entire edge of the adhesive pad 5. Press the needle button with one quick motion to completely insert the needle 8 Start Insulin Delivery

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. 8 Medtrum Simplifying Diabetes Home Screen Delivery Status 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 Read Pump Icon Shape and Color Description Grey ring Grey ring indicates that there is no activated Pump. Green ring Green ring represents the basal delivery. Green and dark green ring Green ring with dark green part represents Temp Basal, the dark green part indicates the progress of Temp Basal delivery. Blue and dark blue ring Blue ring represents the Normal Bolus, the dark blue part indicates the progress of delivery. Purple and dark purple ring Purple ring represents the extend Bolus, the deep purple part indicates the progress of delivery. m o c m u r t d e m w w w

. Red ring Red ring represents the delivery suspend status. Medtrum Simplifying Diabetes 9 8 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

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. 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 10 Medtrum Simplifying Diabetes 1 Main Menu Bolus Manual bolus Manual Bolus 4 Slide to deliver 2 Set Bolus dose 3 Set Bolus type Normal Bolus Extended Bolus Set duration Combo Bolus Tap blue/purple plus sign to set proportion of Normal part and Extended part Set duration

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. Medtrum Simplifying Diabetes 11 Food Bolus Calculator 1 Main Menu Bolus Bolus Calculator 4 Slide to deliver Normal Bolus Extended Bolus Set duration Combo Bolus Tap blue/purple plus sign to set proportion of Normal part and Extended part Set duration 2 Enter BG or Carb, or both

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. 3 Set Bolus dose and Bolus type 12 Medtrum Simplifying Diabetes A Bolus is being delivered Bolus Suspend Main Menu Suspend All No Bolus is being delivered Resume Main Menu Resume Suspend & Resume

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. Medtrum Simplifying Diabetes 13 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 our release tool. Gently remove the entire Patch Pump. Use a medical adhesive remover or baby oil if necessary. Hold the both ends of the Pump Base and pull up the Pump Base to 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. w w w m e d t r u m c o m

. Warning: Once the Patch is removed from the skin, do not attempt to press the needle button again. Doing so will result in injury. 14 Medtrum Simplifying Diabetes Alert Emergency Kit PDM Message Actions to Take END OF SUSPEND Check BG. Resume basal delivery if 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. Alarm (High Priority) Alerts & 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 Power Bank Instructions from your healthcare provider about how much insulin to inject if pump delivery is interrupted

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. PDM Message Actions to Take OCCLUSION DETECTED Change Patch. Check blood glucose. Alcohol wipes Glucagon emergency kit PATCH ERROR Change Patch. Check blood glucose. Emergency contact phone numbers PUMP BASE ERROR Remove Pump. Contact customer support Check blood glucose. If traveling, a copy of a letter from your healthcare provider for airline security Medtrum Simplifying Diabetes 15 Basal Pattern Name: ___________________ Basal Pattern Name: ___________________ Start Time Rate (U/H) Start Time Rate (U/H) Start Time Rate (U/H) Start Time Rate (U/H) Your Personal Settings Max Basal Rate: ________________ U/H

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. Name Heavy Exercise Medium Exercise Light Exercise Sick Temp 1 Temp 2 Temp 3 16 Medtrum Simplifying Diabetes U/H U/H U/H U/H U/H U/H U/H

% or

% or

% or

% or

% or

% or

% or Rate Duration Start Time I:C (g Carb) Start Time ISF (mmol/L) I:C Ratio 1 U :

1 U :

1 U :

1 U :

1 U :

1 U :

1 U :

g g g g g g g Your Personal Settings Insulin Sensitivity 1 U :

1 U :

1 U :

1 U :

1 U :

1 U :

1 U :

mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L mmol/L BG Target (mmol/L) Max Bolus: __________________________U Start Time Low Limit High Limit Active Insulin Time: _______ : _______

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. Medtrum Simplifying Diabetes 17 Caution

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. 18 Medtrum Simplifying Diabetes Caution

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. Medtrum Simplifying Diabetes 19 Medtrum Technologies Inc. 7F, Building 8, No. 200, Niudun Road Shanghai 201203, China Tel: +86-21-50274781 Fax: +86-21-50274779 EC REP 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-201 IM881160WW 348644 Version:1.00

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. 0197 TouchCare Insulin Pump System Quick Start Guide (mmol/L)

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ef ex\ 775 Montague Expressway a a Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 F828, Ey} _ an Email: certification@bureauveritas.com Website: https://www.cps.bureauveritas.com/

Confidentiality Request Letter Reason for Amendment (current / obsolete) To Approved Date Initial Release (obsolete) _ mal g L Nov-14-2006 |

____ Adding CFR 2.459 (obsolete) [ 0 | 2.0, ___ August - 11 - 2008 Updated company template & Added text box | 2.0 3.0 Jan-31-2012

[a beetbe Wale eeveeeep ress os eta ee Bae __ Added IC confidentiality letter form (obsolete) estes 08s tin 40 | March-26-2015 |

Corrections to STC form. Added reference to KDB | 4.0 5.0 | Nov-19-2015 |

fon acest abe Setul(ObSOWH) Ears ae eT fit ok Suet ly ae sal Updated company logo (current) = ss | 5.0 (sS _Updated References and Contact Info SRO =] 1 ia SCS-F019: Confidentiality Request Letter Page | of 2 Rev 7.0 MEDTRUM TECHNOLOGIES Inc.

(2021/3/17) To:

Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046-1609 Ce:

Bureau Veritas Consumer Products Services Inc. 775 Montague Expressway Milpitas, CA 95035 Subject: Confidentiality Request for FCC ID:2AARU-FM018 Pursuant to CFR 47 sections 0.457 and 0.459, we respectfully request permanent confidential treatment of the following Exhibits accompanying this application be held confidential:

Type of Confidentiality Requested Exhibit Short Term & Permanent Block Diagram Short Term External Photos Short Term Permanent! Internal Photos C) Short Term & Permanent Operational Description/ Theory of Operation Short Term Permanent Parts List Short Term C) Permanent Tune-Up Procedure Short Term & Permanent Schematics

] Short Term Test Setup Photos

) Short Term 1) Permanent ' User's Manual The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. Permanent Confidentiality:

The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality:

To avoid premature release of sensitive information prior to marketing or release of the product to the public, the applicant requests the following documents contained in this certification application be temporarily withheld from public disclosure for an initial period of 45 ) or 180 (days; or for a specified date of not to exceed 180 days from the Grant Date The applicant understands that disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Client's signature:

Client's name & title: Sherry He se . Hoe Contact information / address: MEDTRUM TECHNOLOGIES Inc./7F, Buiding 8, 200 Niudun Rd Shanghai China

"Permanent confidentiality may be requested in accordance with FCC KDB 726920 SCS-F019: Confidentiality Request Letter Page 2 of 2 Rev 7.0