Clipsulin C3 User Manual

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▲ Store this device in -20°C ~ 70°C (-4°F ~ 158°F)

▲ Relative Humidity: 10% ~ 90% R.H.

▲ Avoid storing the device under direct sunlight. ▲ Keep out of reach of children.

STORAGE & TRANSPORTATION

∙ Recycle or dispose of the device and the battery separately, in accordance with applicable federal, state, and local regulations.

∙ This product contains a button battery CR2032.

DISPOSAL

SUPPORT INFORMATION

ShengHuo Technology Ltd. 11F, No. 31, Section 3, Zhongshan North Road, Zhongshan District, Taipei City 104, Taiwan Tel: +886 2 25869597 Website: www.diabnext.com

Mdi Europa GmbH Langenhagener Str. 71, D-30855 Langenhagen, Germany Tel: +49-511-3908 9530 Web: www.mdi-europa.com E-mail: [email protected]

▲ BEFORE USING CLIPSULIN®, CAREFULLY READ ALL INSTRUCTIONS AND THE "TERMS OF USE" ON THE MOBILE APP.

▲ Check CLIPSULIN

for any physical damage each time before use.

▲ The CLIPSULIN

is currently only intended to be used with 1.0-unit insulin pens.

▲ If you have any questions, please contact customer service for more information. ▲ If you regularly use two diﬀerent insulin pens, please pair each pen with two separate CLIPSULIN

devices to avoid unidentiﬁable data.

▲ DO NOT use your CLIPSULIN® without previously pairing it.

PRECAUTION

CLEANING INSTRUCTIONS

Use a dry cloth to wipe the outer surface of the CLIPSULIN®.

O NOT immerse CLIPSULIN® in any ﬂuids.

DO NOT

spray any ﬂuids at or into CLIPSULIN®.

DO NOT

use CLIPSULIN® with any acid or alkaline solutions.

Cleaning, disinfecting, or testing liquid may damage CLIPSULIN

Data recording malfunction may occur if there is excessive bodily movement or vibration of the CLIPSULIN® and insulin pen during use.

Each CLIPSULIN® should only be used on one insulin pen model only. Sharing the CLIPSULIN® may lead to unidentiﬁable data.

Always select the correct pen in the APP. If you change pen or insulin type, modify the pen selection in the APP list accordingly.

After replacing the battery, sync the CLIPSULIN® with the DIABNEXT® app to allow the CLIPSULIN® to adjust its time.

CAUTION

Manufacturer

Authorized Representative in the European Community

Keep Away From Sunlight

-20°C

70°C

WARNING

DO NOT use if any part of your CLIPSULIN® appears damaged.

DO NOT use on insulin pens that are not dosed with single unit increments.

DO NOT operate or store CLIPSULIN® under improper environmental conditions. * refer to the “CLIPSULIN® Description" and “Storage & Transportation" sections

If any physical irritation or discomfort occurs during the use of CLIPSULIN®, please stop using the device immediately, and contact your healthcare provider or customer service.

Data within CLIPSULIN® will be overwritten if you do not transfer your records to the DIABNEXT® APP regularly. (Device memory: 200 injections) The NFC connection can only transmit the lastest 50 records in your CLIPSULIN®.

Keep out of reach of children, as small parts may be swallowed and pose a choking hazard.

If CLIPSULIN® is not synced with the APP to adjust its time after battery replacement, incorrect timestamps of the records may occur.

CLIPSULIN® DESCRIPTION

The CLIPSULIN® is a removable memory recorder designed to be used with the following insulin pens: Lilly KwikPen®, Lilly HumaPen®, Novo Nordisk FlexPen®, Novo Nordisk FlexTouch®, Sanoﬁ SoloStar®, and Sanoﬁ ClikStar®. (The CLIPSULIN® is currently only intended to be used with 1.0-unit insulin pens.) The dose, date, and time of injection are stored in the CLIPSULIN®, and through a Bluetooth/NFC connection, this information can be transmitted to the DIABNEXT® APP on your smartphone/tablet for easy access and review.

ABOUT

LED (Red/Green)

LCD

Power Button Data Validation Button Data Transmission Button

-1 Button+1 Button

Green light blinks

Data recorded

Red light blinks Battery level low

DEVICE LED SIGNAL DESCRIPTION

After you see the low battery LED indication for the ﬁrst time, the device will allow you to perform one additional week of injections. Replace the battery CR2032 as soon as possible to avoid loss of data storage.

Battery type

Battery life

Lithium Coin Cell Battery (CR2032)

Weight 9 grams

Size L 46mm X W 25mm X H 23mm

1800 injections

Shelf life 2 years

Data transmission

Bluetooth: latest 200 records

NFC: latest 50 records

Device memory 200 injections

Operating temerature 5°C ~ 40°C (41°F ~ 104°F)

Relative humidity 10% ~ 90% R.H.

APP operating system iOS/Android

Wireless connection Bluetooth Smart/NFC

Maximum allowed RF output power

+4 ~ -40 dBm

Frequency range 2.402GHz ~ 2.480GHz

UNIVERSAL INSULIN PENS RECORDER

Temperature Limit: -20°C ~70°C

(-4°F ~158°F)

IFU-CS03E1-A-1712

Model No: C3

Transfer your records to the DIABNEXT® app regularly to avoid losing data stored in CLIPSULIN®.

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3. USING THE CLIPSULIN

1. SETUP

HOW TO OPERATE YOUR CLIPSULIN

DATA TRANSMISSION BATTERY

FCC STATEMENT

Install a new battery.

Clip the CLIPSULIN® onto your insulin pen in a way that allows you to see the LCD screen next to the unit window of your insulin pen.

Select your injection dose on the insulin pen.

Remove the cap of your insulin pen and install the needle. Click the power

button to turn on the CLIPSULIN®.

Transfer your stored records before replacing the battery.

BATTERY REPLACEMENT

Open the battery compartment.

Replace the old battery with a new one.

Push the compartment back into the CLIPSULIN

to close it.

Battery

Click the power button to check the status of CLIPSULIN

Sync your device with the DIABNEXT

APP before using it again, to ensure that the timestamps of the records will be correct.

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. This device must accept any interference received, including interference that may cause undesired operation.

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.

Changes or modiﬁcations not expressly

approved by the party responsible for compliance could void the user’s authority to operate the equipment.

Verify that the number of units displayed on the

CLIPSULIN® is the same as the selected dose on the insulin pen.

If the numbers are not the same, use the “ + ” or “ - ” button to adjust manually the units on the

CLIPSULIN®.

2. BEFORE FIRST USE

Go to www.diabnext.com/app and install the DIABNEXT® APP on your mobile device.

Turn on the Bluetooth function of your

mobile device and open the DIABNEXT® APP.

Click “Insulin Pens” and select your insulin pen type.

Enter the menu, select “My Tools” and click “Add Tools”.

Attach the CLIPSULIN® near the dosage window.

Ensure that your CLIPSULIN® is tightly ﬁtted onto your insulin pen.

Battery type: CR2032.

Refer to “Battery Replacement" section.

TROUBLESHOOTING

If there is no LCD display and/or LED signal light feedback of CLIPSULIN

, please follow the steps below:

Check if there is any physical damage to the CLIPSULIN

. If yes, stop using the device and replace it with a new one. If no, check the LCD and LED functions. If only the LCD display OR the LED signal light is not functioning, stop using the CLIPSULIN

and replace it with a new one. If both the LCD and LED are not functioning properly, replace the battery and check both functions again. Caution: After replacing the battery, before using the CLIPSULIN

with your insulin pen, sync the

CLIPSULIN

with the DIABNEXT® APP to adjust its time. If the problem persists, go to customer service. (www.diabnext.com/Q&A)

If the CLIPSULIN® cannot connect with the DIABNEXT

APP, please follow the steps below:

Check if there is any physical damage to the CLIPSULIN

. If yes, stop using the device and replace it with a new one. If no, reboot the Bluetooth/NFC function on the mobile device, and then try to connect with the CLIPSULIN

again. If rebooting the Bluetooth/NFC function does not resolve the issue, reinstall the DIABNEXT

APP,

then try to connect with the CLIPSULIN

again. If the problem persists, go to customer service. (www.diabnext.com/Q&A)

If the injection data cannot be transferred to the DIABNEXT

APP, please follow the steps below:

Check if there is any physical damage to the CLIPSULIN

. If yes, stop using the device and replace it with a new one. If no, reboot the Bluetooth/NFC function on the mobile device, and then try to connect with the CLIPSULIN

again. If rebooting the Bluetooth/NFC function does not resolve the issue, reinstall the DIABNEXT

APP,

then try to connect with the CLIPSULIN

again. If the problem persists, go to customer service. (www.diabnext.com/Q&A)

If you see the “Device error, please contact customer service" message pop up in your APP, please follow the steps below:

1.2.When this message pops up, it means that some records in the memory might be damaged. Please conﬁrm the message and go to customer service. (www.diabnext.com/Q&A)

BLUETOOTH NFC

Open the DIABNEXT® APP.

Enable the NFC (Near Field Communication) function on your mobile device. Note: For iPhone users, you may skip this step.

Enable the Bluetooth function on your mobile device.

You can use the NFC transmitting function with your mobile phone if you have:

- iPhone 7 or newer, and have the iOS 11 system updated or newer.

- Android phone with NFC function.

You can use the Bluetooth transmitting function with your mobile phone if you have iOS / Android with BLE 4.0 or higher.

Press and hold down the power button of CLIPSULIN

, until you see the double dash “- -” blinking on the LCD screen, to pair with the APP.

“- -” will be displayed on the screen of CLIPSULIN

The NFC transmitter of the CLIPSULIN® is near the power button. Please conﬁrm the NFC transmitter location of your smartphone/tablet, and be sure to have your smartphone/tablet close to your CLIPSULIN® for proper pairing/syncing.

Follow the instructions on the APP.

Your stored records will be transferred automatically, and can be viewed on your mobile device.

The CLIPSULIN

will automatically transmit the stored injection data under these conditions:

1. You have paired your CLIPSULIN

with the DIABNEXT® APP before.

2. The Bluetooth/NFC function is enabled on your smartphone or tablet.

3. Your smartphone or tablet is nearby with the DIABNEXT

APP open amd connected to

your CLIPSULIN

★

The dose, date, and time of injection will be automatically stored in your CLIPSULIN®.

Your

CLIPSULIN® can store up to 200 records, but the NFC connection can only transmit the latest 50 records in the memory. Transfer your records regularly to your smartphone or tablet to keep track of your injections.

Press and hold down the power button

of CLIPSULIN

, until you see the double dash “- -” blinking on the LCD screen, to pair with the APP.

“- -” will be displayed on the screen of CLIPSULIN

Open the DIABNEXT® APP.

Follow the instructions on the APP.

Your stored records will be transferred automatically, and can be viewed on your mobile device.

It will take a few seconds to connect.

“- -” will be displayed on the screen of CLIPSULIN

Conﬁrm the two numbers are the same, then click the blue button (Power) to validate and send your dosage data.

Perform your injection in your normal manner.

The green light and the LCD will blink to signal that the data has been recorded.

You can increase the number gradually by holding down the “+” (plus) button, or decrease the number gradually by holding down the “-” (minus) button.

The data will not be recorded if the green light and the LCD have not blinked.

Your data will be automatically transmitted to your mobile APP after injections. (See the “ ★ ” part.)

If you do not want your data to be transferred automatically, please refer to the “Data Transmission" section.

The device will automatically shut down after 10 seconds of inactivity.

Follow the instructions on the APP. (Press and hold down the power button of CLIPSULIN

, until you see the double dash “- -” blinking on the LCD screen, to pair with the APP.)

“00” will be displayed on the

CLIPSULIN®

screen.

Ensure that your hands DO NOT come into contact with the

CLIPSULIN

during dose selection.

If you see the “Device error, please contact customer service” message pop up, please refer to the “Troubleshooting” section.

Only the latest 50 records can be read out via NFC connection. Transfer your records at least once per week to keep track of your injections.

CLIP

+1 UNIT

-1 UNIT

NFC signal

emitting point

DIABNEXT

DIABNEXT DIABNEXT