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Summary of Contents for insulCHEK DOSE
- Page 1 Insulin Injection Tracker User Manual Doc.ID: DRAFT V.8.3.6 Issued:2022-11...
- Page 2 IC-Dose Thank you for using InsulCheck DOSE. This User Manual provides important information to help you use your InsulCheck DOSE correctly and get the most benefit from its use. Before using the product, please read it carefully. If you have any questions about this product, please: •...
- Page 3 Innovation Zed only accepts responsibility for the equipment’s safety, usability, and performance if: • the equipment is used in accordance with its intended use and • the equipment is used in accordance with the product documentation InsulCheck DOSE does not make any decisions or suggestions about your injection regime.
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Page 4: Table Of Contents
1.6 Contraindications ......8 2 Device Description 2.1 Package contents ......9 2.2 Symbols ........11 2.3 InsulCheck DOSE terminology ..13 2.4 Insulin pen terminology ....14 2.5 Supported pens ......15 2.6 Function description...... 16 2.7 Performance ........ 16 3 Operating instructions 3.1 First time use ...... - Page 5 3.8 Factory reset ....... 26 4 Cleaning and care 4.1 General cleaning ......27 4.2 Sensor Cleaning ......27 5 Disposal 6 General safety advice 7 Troubleshooting 7.1 Injection not detected ....30 7.2 Blinded sensor ......30 7.3 Spillage ........30 7.4 System error .......
- Page 6 10.2 Environment and operating ..36 10.3 Accuracy ........36 11 Declarations...
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Page 7: Introduction
InsulCheck DOSE is clipped-on to your insulin injection pen. InsulCheck DOSE must not be used as the only indicator to decide when or how much insulin to inject. You must rely on your own memory and knowledge, your blood glucose level and your healthcare provider’s advice when deciding to inject. -
Page 8: Normal Use
1.5 Normal use InsulCheck DOSE is mounted on the insulin pen by the user. The device is on the pen when injecting. The time since previous injection and dose dialled is displayed on the display screen. Once mounted, the device need not be removed from reusable pens. When used with disposable pens, once the insulin runs out, the device is removed and mounted on a new disposable pen. -
Page 9: Device Description
USB charging cable Do not use the Device if packaging is damaged or opened Do not use InsulCheck DOSE if any part appears to be broken or damaged. InsulCheck DOSE supports a variety of insulin pens. Each device designated to work with only one specific pen model (see section 2.3 for supported pens). - Page 10 It is your responsibility to ensure that you are using the correct Device for your pen. Consult your healthcare provider if you are unsure which insulin pen model you are using.
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Page 11: Symbols
2.2 Symbols The following table describes the meaning of the symbols used in the User Manual, the Packaging and the Label on the bottom of the Device. Symbol Meaning This action is prohibited. User should read very carefully. Important information, warning or precaution. User should read carefully. - Page 12 Range of humidity (upper and lower limit, noncondensing) to which the Device can be safely exposed to during transportation and storage.
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Page 13: Insulcheck Dose Terminology
2.3 InsulCheck DOSE terminology The following images describe the key components of InsulCheck DOSE. ① Display screen – Timer and other information are displayed on it. ② Charging indicator – Displays the charging status. ③ Sleeve – The sleeve can only be fitted properly on a specific pen model. -
Page 14: Insulin Pen Terminology
2.4 Insulin pen terminology ① Dose-knob – the knob at the end of the insulin pen which is dialled to adjust the desired dosage of insulin. ② Dose-indicator – the number of dialled-out insulin units. After mounting the InsulCheck DOSE on a pen, the dose-indicator is visible through the window in the sleeve. -
Page 15: Supported Pens
2.5 Supported pens InsulCheck DOSE is clipped onto the insulin pen using the sleeve, hinge mechanism and mounting mechanism. The unique design of the sleeve means that the device will only fit properly and operate correctly on the designated model of pen. The abbreviation for the pen names the device is designated for, is embossed on the sleeve. -
Page 16: Function Description
InsulCheck DOSE must not be used as the only indicator to decide when or how much insulin to inject. You must rely on your own memory and knowledge, your blood glucose level and your healthcare provider’s advice when deciding to inject. -
Page 17: Operating Instructions
Always ensure that the needle is covered before attching or removing the device. a. Align the dose-indicator window on the sleeve with the dose- indicator on the pen. Confirm the chamfered edge of the InsulCheck DOSE is positioned near the dose knob of pen. - Page 18 InsulCheck insignia is displayed The mounted-on pen animation is displayed when device is locked in place securely to the injection pen. Followed by the dashed timer is displayed and dashed Dose display since no injection has been detected yet...
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Page 19: Normal Injection Routine
“wake-up” when the device detects any motion or when the display is “double tapped” NOTE: The device display must be on before dialling any dose. If the device display is not on, double tap screen to turn on When dialling out the dosage the InsulCheck DOSE will automatically begin tracking the dosage dialled –... - Page 20 5 sec. The display will automatically dim and turn off after 20 Sec to conserver power. For effective tracking of injection dose, do not combine priming amount into amount dialed for medication.
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Page 22: Battery Status
Low battery the device display will turn on and show the elapsed time since the last injection and after 3 sec will display the last dose Your injection time will be detected even after a low battery warning is displayed, but you should charge the device before the next injection. -
Page 23: Charging
% indicating charge capacity. After 5 sec showing charging animation the display will show the last injection time and Dose for 20 sec before turning off. The device can be safely charged while attached to the pen. The user should not... -
Page 24: Bluetooth® Pairing
3.5.1 Maximum number of pairings InsulCheck DOSE can be paired with a maximum of 3 different client devices (e.g. different smartphones or apps). When you pair with a fourth client device your InsulCheck DOSE will automatically drop the first client device you connected with to accommodate the new client. -
Page 25: Clearing Paired Devices
Dose window of the insulin pen. Press (click) together the mounting mechanism to fasten the Device on the If the Device is correctly mounted, the animation below is displayed. After the change, the timer will show the last dose and time as normal... -
Page 26: Factory Reset
3.8 Factory reset All the data stored in the InsulCheck DOSE memory as well as the pairing data can be deleted by doing a Factory Reset. InsulCheck DOSE also reboots as a result of a factory reset. Unmount the Device from the pen... -
Page 27: Cleaning And Care
4 Cleaning and care 4.1 General cleaning The display and outside body of your InsulCheck DOSE can be cleaned while mounted on the pen by wiping it gently with a clean cloth lightly moistened with water. The cloth should not leave any water droplets on the surface of the Device. -
Page 28: Disposal
Do not use the Device if abnormal heat, odour, discolouration, deformation, or other abnormal condition is detected during use, charging, or storage. Do not use the Device in oxygen-rich environments Make sure that no excessive dust, moisture, water or other agent builds- up on the optical sensor of the Device. -
Page 29: General Safety Advice
Device (for example, CE marked, etc.) to minimize the risk of electric shock and damage to the Device. In the unlikely event of deterioration in the functionality of nearby equipment in the presence of InsulCheck DOSE, remove the Device from the vicinity. To avoid degradation in performance of InsulCheck DOSE, radio equipment (such as phones, computers, wireless devices, antennas, antenna cables etc.) should not be used closer than 30 cm (12 inches) -
Page 30: Troubleshooting
7.2 Blinded sensor The optical sensor of the Device is blinded when exposed directly to intense light (e.g. bright sunlight) and cannot detect the activity of the dose- knob. The screen will display the blinded sensor warning. If this happens, take the device out of the intense light until the warning is no longer displayed. -
Page 31: Unsuccessful Pairing
1.It may be that the passkey was mistyped into the app or phone. Repeat the process or follow the instructions on your phone or app. 2. Check that your smartphone or app supports connection to your InsulCheck DOSE. 3. The Bluetooth ®... -
Page 32: Long Delay Indication
7.14 too fast dialling indication The dose knob was dialled too fast, so no dosage is recorded. Please dial slower next time. The next correct injection record can update the no dosage record displayed. -
Page 33: Display Guide
The last injection time: Blank time Time since the last injection (right after performing an injection) The last injection time: < 24 hrs The last injection time: > 24 hrs contains day count (max 99) The last injection dose: Blank dose... - Page 34 UI name Artwork layout The last injection dose: Normal use display of units recorded Error reason: Too fast dialling Toggle: ⇔ Error reason: Opened sleeve Toggle: ⇔ Toggle: The last injection dose with error ⇔ reason: Incomplete injection Detecting the turned knob...
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Page 35: Contact Information
9 Contact information 9.1 Support Web: www.innnovationzed.com Email: info@innovationzed.com 9.2 Manufacturer Manufactured for Innovation Zed Ltd., NovaUCD, Belfield Innovation Park, Belfield, Dublin 4, Ireland by Scandinavian Healthcare Ltd. Taiwan 9.3 Warranty For the terms and conditions of the warranty, please see the separate warranty card (included in the package or provided by the local distributor). -
Page 36: Technical Specifications
-5⁰C to 45⁰C @ 10-75% RH (Non-Condensing) Transport/Storage Degree of enclosure IP22 Vibration/ Shock/ 60601-1-11 Bump/ Drop/ Free fall Pressure 700hPa to 1050hPa 10.3 Accuracy Measurement 99%* Accuracy * T est bench results. External factors may affect the dose measurement accuracy. - Page 37 11 Declarations Transportation worldwide by air, road, ship and train This device has been tested to meet the electrical and safety requirements of: Medical Electrical Equipment EN61000-6-3: 2007+A1:2011, EN61000-6-1 : 2007, EN61000-4- 2 : 2008, IEC 61000-4-3 : 2006+A1:2007+A2:2010, IEC 61000-4-8 : 2009, EN 62479:2010, EN5514-2:1997+A1:2001+A2:2008 RoHS Directive 2011/65/EU - IEC 62321-1:2013: Electromagnetic compatibility...
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