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1 | User manual | Users Manual | 1.70 MiB | April 17 2023 |
Insulin Injection Tracker User Manual Doc.ID: DRAFT V.8.3.12 Issued:2023-04 Innovation Zed Ltd. NovaUCD, Belfield Innovation Park, Belfield, Dublin 4, Ireland 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:
Consult our website www.innovationzed.com Email our Customer Support Team info@innovationzed.com IMPORTANT Read all instructions and warnings before use. Innovation Zed only accepts responsibility for the equipments 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. Table of Contents Contents 1 Introduction 1.1 Definitions ..................................... 7 1.2 General description ......................... 7 1.3 Intended Use ................................. 7 1.4 Intended Users ............................... 7 1.5 Normal use .................................... 8 1.6 Contraindications ............................ 8 2 Device Description 2.1 Package contents ............................ 9 2.2 Symbols ...................................... 10 2.3 InsulCheck DOSE terminology ........ 11 2.4 Insulin pen terminology ................. 12 2.5 Supported pens ............................ 13 2.6 Function description ...................... 14 2.7 Performance ................................ 14 7 9 3 Operating instructions 15 3.1 First time use ............................... 15 3.2 Mount Device on the Injection pen .. 15 3.2 Normal Injection Routine ............... 17 3.4 Battery status .............................. 20 3.4 Charging ..................................... 21 3.5 Bluetooth pairing ....................... 22 3.5.1 Maximum number of pairings....... 22 3.6 Clearing paired devices .................. 23 3.7 Changing Pen ............................... 23 3.8 Factory reset ................................ 24 4 Cleaning and care 4.1 General cleaning ........................... 25 4.2 Sensor Cleaning ........................... 25 5 Disposal 6 General safety advice 7 Troubleshooting 7.1 Injection not detected ................... 28 7.2 Blinded sensor ............................. 28 7.3 Spillage ....................................... 28 7.4 System error ................................ 28 7.5 Unsuccessful pairing ...................... 29 7.6 Critical Battery ............................. 29 7.7 Injecting while charging ................. 29 7.8 High temperature indication ........... 29 7.9 Low temperature indication ............ 29 7.10 Long delay indication ................... 30 7.11 incorrect mounting indication ........ 30 7.12 firmware update indication ........... 30 7.13 long delay injection indication ....... 30 7.14 too fast dialling indication ............ 30 7.15 Sensor cleaning indication ............ 30 8 Display guide 9 Contact information 9.1 Support ....................................... 33 9.2 Manufacturer ............................... 33 9.3 Warranty ..................................... 33 9.4 Disclaimers .................................. 33 10 Technical specifications 10.1 Specifications ............................. 34 25 26 27 28 31 33 34 10.2 Environment and operating .......... 34 10.3 Electromagnetic compatibility ....... 34 10.4 Accuracy .................................... 35 11 Declarations 36 1 Introduction 1.1 Definitions Device InsulCheck DOSE User Insulin pen user, Patient or Operator 1.2 General description InsulCheck DOSE helps you track your insulin injections. It can streamline your diabetes management by automatically logging injections events into a paired diabetes management app. You can easily identify the previous dosage amount dialled and the time since last injection on the display, helping you to stay on top of your injection routine. 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 providers advice when deciding to inject. 1.3 Intended Use InsulCheck DOSE is an add-on device for insulin injection pens to support users by automatically capturing and displaying injection event data, such as time of injection and the dialled dosage. InsulCheck DOSE does not change or modify the function of the injection pen, nor does it make any decisions or recommendation as to the timing or dosage to be administered. The Device is intended to be used in common environments such as your home, office, or school. The Device is intended for users who see a benefit in logging their injection event data. This data can be logged either manually by the user or automatically by wireless transmission. InsulCheck DOSE should not be used as the sole or primary source for informing injection decisions. 1.4 Intended Users InsulCheck DOSE is intended for people with at least 8 years of school education living with diabetes who are able to manage their treatment without the use of the device, and their care givers. The intended users are expected to be familiar with the normal aspects of insulin usage and the operation of injection pens. 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. InsulCheck DOSE has a lithium-ion battery that is rechargeable when a low battery is indicated Using Bluetooth technology, data from the Device can be transferred to a compatible connected app (e.g., smartphone app). For users who see a benefit to logging their injection events to keep track of their usage behaviour and of monitoring their drug adherence record. 1.6 Contraindications InsulCheck DOSE should not be used by users who are unable to manage their treatment without the use of the Device. 2 Device Description 2.1 Package contents Included in the box is:
a) InsulCheck DOSE (Device) b) Documentation (Quick Start Guide) c) 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). InsulCheck DOSE cannot detect that it is fitted on the wrong pen Use the cable supplied with the device to connect it to a USB power port. Do not use any other cable. Connect the USB cable to a power source compliant with the IEC 60601-
1. Before using, please check that you have purchased the Device designated for the model of pen you use. 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. 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. Consult instructions before use, electronic form available from http://innovationzed.com/ifu-documents Name and address of manufacturer. Year-month of manufacture. Model number of the Device. BLE (Bluetooth Low Energy) name of the Device. Rating of the USB charger. Do not dispose as normal household waste. Dispose separately as Electronic Equipment waste. The Device Complies with relevant EU Regulations. Do not use the Device if packaging is damaged or opened. IP22 Degree of enclosure protection. Protect Device from moisture. Avoid using the Device under direct sunlight. Range of temperature (upper and lower limit) to which the Device can be safely exposed to during transportation and storage. Range of humidity (upper and lower limit, noncondensing) to which the Device can be safely exposed to during transportation and storage. 2.3 InsulCheck DOSE terminology The following images describe the key components of InsulCheck DOSE. Display screen Timer and other information are displayed on it. Charging indicator Displays the charging status. Sleeve The sleeve can only be fitted properly on a specific pen model. Reset button Hole for accessing the reset button using a paperclip or similar tool. Sensor Windows used by sensors to detect Pen motion. Bottom label Carries Device identification and other important information. Dust Cover Protects the charging inlet. Sleeve Window Aligns with Dose window of insulin pen. Pen Model 2 digit code indicating insulin pen supported by the sleeve. 2.4 Insulin pen terminology Dose-knob the knob at the end of the insulin pen which is dialled to adjust the desired dosage of insulin. 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. 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. The following table provides a list of pen models supported by InsulCheck DOSE together with their abbreviation. Pen Manufacturer Pen model Pen Code. Supported Drug Variation Novo Nordisk NOVOPEN5 NP5 Novo Nordisk Flextouch FT Eli Lily Kwikpen KP Sanofi Solostar SS Mix25 Mix50 U100 U200 Abasglar Toujeo Lantus Ensure that the correct device variation is used with your pen 2.6 Function description InsulCheck DOSE is clipped-on to your insulin injection pen. InsulCheck DOSE is secondary aid in diabetes management, by providing information about the timing of injections and number of units of insulin dialled. You can easily identify the previous dosage amount dialled and the time since last injection on the device display at any time, helping you to stay on top of your injection routine. The sleeve, hinge mechanism and mounting mechanism are used to clip the Device onto the pen. Each Device is designated to be used with a specific model of insulin pen. This is due to the unique design of its sleeve that will only fit properly on the designated model of pen. The internal sensors detect dialling-in and out of the dose-
knob only if the Device is correctly mounted on the pen. InsulCheck DOSE helps you track your insulin injections. It can also be used to streamline your diabetes management by automatically logging injections events into a paired with a compatible diabetes management app. 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 providers advice when deciding to inject. 2.7 Performance When the operating instructions, safety regulations and care requirements are properly followed, InsulCheck DOSE will continue to automatically detect and record injection time, date and dosage dialled and if paired with an app, transfer data to connected apps, as described in this manual during its service life. Do not use the Device if you observe a deterioration in any of these functions. A decrease in charging interval can be expected due to normal battery degradation. Contact our customer support team at info@innovationzed.com if the Device does not behave as specified in this manual, especially if proper screens are not displayed or the detection threshold increases. Nominal InsulCheck DOSE performance listed is based on standard test bench conditions. Dialled dosage detection 95% +/- 1U Injection detection 99%
3 Operating instructions 3.1 First time use Remove the protective strap around device 3.2 Mount Device on the Injection pen 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. 0 b. Push the sleeve onto the pen c. Press (click) together the mounting mechanism to fasten the Device on the pen If mounted correctly the Chamfer ed of the device should be near the Injector button of the pen as shown here. On first mounting the device powers on and the 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 Mounting Successful Display Dashed Unit Display Dashed Timer Display To save power, the screen will turn off after a few seconds. Always ensure that the device is fitted firmly and securely when attaching to a new pen 3.2 Normal Injection Routine Ensure that the device is attached to the pen and the display area is face up the Display will turn on and device will 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 it will display the image below while dialling. When desired dose is set perform the injection according to your therapy When injection is completed the timer resets due to the new injection and starts counting up. After 10 Sec the display will also show the number of units dialled for the last injection and then toggle between the elapsed time and the dose every 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. 3.3 Checking last injection status Ensure that the device is attached to the pen and ensure that the display area is always face up and double tap the screen to turn on the display and wake up device. If there are no warnings, the device display will turn on and show the elapsed time since the last injection and after 3 sec will display the last dose Tap 2 times day hr min Time elapsed since the last injection dosage last injection The display will automatically dim and turn off after 20 Sec to conserver power. 3.4 Battery status Double tap the screen to turn on the display and wake up device If the battery is low, the following battery warning is displayed for a few seconds 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. If the battery is critical, the following battery warning is displayed for a few seconds Critical Battery The display will turn off immediately If the device is blinking critical battery warning it may not record your next injection. it is important that you charge the device immediately. NOTE: Keep your Device charged for optimised operation 3.4 Charging Open the dust cover protecting the charging port and connect the micro-USB charging cable The LED on the top display will light up as soon as the USB charger is connected. Pulsing Green
(Charging in progress) Constant Green
(Fully charged In addition to the LED lighting up, the display will show a charging animation along with an approximate % 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 perform injections with the charger cable connected to the device The Device can be disconnected from mains power at any time by removing the charging cable from the Device or from the charger, or by removing the charger from the mains outlet. It will take approximately 2 hours to fully charge from low battery. When fully charged the device can operate for 7-10 day in typical use. While the device is connected to a charger the user shoud not perform an injection. The following Icon injection while charging. will appear as a reminder not to perform 3.5 Bluetooth pairing The information on time intervals between injections is stored on the Device for up to 40 days. You can transmit this information to your smartphone app via Bluetooth To initiate the pairing process please refer to your specific smartphone app. 1. Wake up your device by double tapping on the screen 2. Follow your app instructions to scan for available devices 3. On the app select the Device from the list of available devices. The BLE name of your Device is written on the label on the underside of the Device and on the packaging 4. Wait for the Device to display the passkey 5. Type the passkey into the prompt on your app or phone 6. If pairing is successful, the animation below will be displayed a. If pairing is un-successful, the animation below will be displayed. If this occurs follow the instruction on your app to try again. 7. Follow the instructions on the paired device to transfer the data saved on InsulCheck DOSE. Depending on the connected app you can monitor your adherence to your medication regime and keep track of your usage behaviour Always check the transferred data (the log of the time and dose dialled) with your personal diary or memory of time and dose. Most 3rd party apps will allow inaccuracies to be corrected within the app. 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. 3.6 Clearing paired devices The device can be unpaired via the smartphone app, please see your app instructions for specific details. 3.7 Changing Pen To remove the device from a used pen and to attach it to your new pen 1. Open the clasp and remove the Device from the current injection pen 2. When the clasp is opened, the unmounted from pen animation (See below) is displayed on the screen Mount the Device on your new injection pen after aligning the Sleeve Window with the Dose window of the insulin pen. 3. Press (click) together the mounting mechanism to fasten the Device on the pen 4. If the Device is correctly mounted, the animation below is displayed. 5. After the change, the timer will show the last dose and time as normal 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. 1. Unmount the Device from the pen 2. Turn the Device around so that the hole for accessing the reset button is exposed and push the reset button with a paper clip or similar tool and keep it pressed for more than 10 second 3. The Device reboots and the InsulCheck insignia is displayed confirming that a factory reset has been triggered 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. 4.2 Sensor Cleaning If the following Icon is displayed This indicates that the sensor windows should be cleaned. The device should be unmounted as described in section 3.7 Sensor windows should be clean and free from dust or fingerprints The sensor should be cleaned with a dry lint free cloth similar to that used for cleaning glasses. There should not be any smudges lint or dust on the sensor windows for best performance. Do not use any other liquids or solvents when cleaning the Device. Do not expose the Device to open flame or put it too close to a heated surface. Device is not waterproof and does not hold protection against excessive infiltration to water. Never pour water or other liquids on the Device. Never submerge the Device in water or other liquids. If this occurs, dry off quickly with a clean cloth. Do not store the Device in a freezer. Do not place Device in Microwave. Do not dissasemble Device. 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. Clean the optical sensor with a clean dry or slightly moistened cloth if any build-up appears. Keep the Device within the specified temperature, humidity and atmospheric pressure ranges. 5 Disposal At the end of the Devices service life, it should be disposed as electrical waste according to local regulations. 6 General safety advice Only use a certified 5V USB charger from a legitimate supplier with the 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) from the Device. This distance should also be observed for the charging cable if it is plugged-in to the Device. To reduce the risk of interference from outside sources, avoid using InsulCheck DOSE near strong sources of electromagnetic radiation (e.g. CT, MRI, X-ray equipment, etc.). To ensure proper operation of the Device, avoid using it adjacent to or stacked with other electrical equipment. Electrical medical devices and systems are subject to special measures concerning electromagnetic compatibility (EMC) and must be installed in accordance with the EMC instructions contained in this enclosed document. Do not attach or tighten cable to or around the head or neck. Cable can cause strangulation. Do not place the Device in a microwave. Avoid continuous contact with device for several hours at a time. Do not leave your Device and its accessories within the reach of small children or allow them to play with it. They could hurt themselves or others or could accidentally damage the Device. The Device contains small parts that may detach and create a choking hazard. The Device is not waterproof. Do not immerse the device in water and do not clean it under running water Do not use Device with items not described in this manual Do not disassemble, modify or repair the device by yourself. Otherwise, it may cause fire,electrical shock, bodily injury, or device malfunction. 7 Troubleshooting 7.1 Injection not detected There are several reasons that injections are not detected consistently. The following can be helpful in fixing the issue:
Make sure that the Device is designated for the pen model it is mounted on (see section 2.5). Make sure that the Device is fitted and positioned correctly on the pen i.e. the optical sensor is positioned close to the dose-knob after mounting (see section 3.1). Press (check for click) the mounting mechanism together to ensure that the Device is properly mounted on the pen. The mounted on pen animation appears when the Device is properly mounted (see section 3.1). Make sure that there is no build-up of dirt, etc. on the optical sensor (see section 3.12 for cleaning instructions). If it is still not working, unmount and re-mount the Device on the pen (see section 3.8) If injections are still not detected contact our Customer Support Team. 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. The Device can now be used normally. 7.3 Spillage Should an accident occur exposing InsulCheck DOSE to a liquid (e.g. a cup getting knocked over causing spillage), remove it from the pen, dry it by wiping gently with a clean dry cloth, and set the Device aside for several hours before resuming its use. The Lithium-Ion battery should not be exposed to water or other liquids. 7.4 System error If the InsulCheck insignia is displayed periodically on the screen, this means that the Device has a repeating system error which it cannot recover from. If that happens, stop using info@innovationzed.com the Device and contact our Customer Support Team at 7.5 Unsuccessful pairing If the device displays the following screen, there was a problem paring the device to the app There are several reasons for an unsuccessful Bluetooth pairing. The most common reasons are:
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 functionality is implemented in different ways by mobile device manufacturers and by app developers. There may be an incompatibility issue which cannot be resolved. If you still cannot pair with the desired client device, please contact our Customer Support Team at info@innovationzed.com 7.6 Critical Battery Battery level is critically low. Please charge the device with the USB cable as soon as possible. 7.7 Injecting while charging Do not inject while charging. Please use the device after charging. 7.8 High temperature indication The pen has been exposed to temperatures above typical recommended temperatures for insulin (nominally < 28C). Suggest checking insulin. 7.9 Low temperature indication The pen has been exposed to temperatures below typical recommended temperatures for insulin (nominally > 2C). Suggest checking insulin. 7.10 Long delay indication There was a long pause between dials. The screen is showing the previous injection record. Please dial the dose knob back to 0 unit and then re-close the latch. 7.11 incorrect mounting indication The device is mounted incorrectly. Please re-mount the device and ensure the Sleeve window aligns with the dosage window. 7.12 firmware update indication The device software is updating. Please use the device after the update completes. 7.13 long delay injection indication There was a long pause between dialling and injecting so no dosage is recorded. Please continue the injection after dialling next time. The next correct injection record can update the no dosage record displayed. 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. 7.15 Sensor cleaning indication Sensor area needs cleaning. Please refer to section 4. For cleaning instructions. 8 Display guide UI name Charging progress Artwork layout Animation:
Green light (LED) n/a Battery full Device logo Firmware version Mounting progress Animation:
Unmounting progress Animation:
High-temperature warning Toggle:
Low-temperature warning Toggle:
Saturation warning Toggle:
Battery low warning Critical battery warning Toggle:
Screen off 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 The last injection dose: Blank dose e.g., contains day count (max 99)
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:
The last injection dose with error reason: Incomplete injection Toggle:
Detecting the turned knob Warning of too fast dialling Toggle:
Unmounting warning Toggle:
Interrupted injection warning Toggle:
Do not inject while charging warning Toggle:
Stand by (screen off) Passkey Successful bonding Un-bonding / Unsuccessful bonding System error and failed system upgrade Toggle:
System upgrade progress Animation:
Sensor area needs cleaning. Please use a lens tissue for cleaning Toggle:
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). 9.4 Disclaimers The manufacturer is not responsible for any problems, damages or malfunctions arising from unforeseeable circumstances. Modification and taking apart the Device is not allowed and may interfere with performance and safety. 10 Technical specifications 10.1 Specifications Name Model InsulCheck DOSE IC-Dose Service life Dimensions Weight Accuracy of the timer Data Storage Battery Power consumption Charger rating Maximum internal working voltage Radio 2 Years 64 x 31 x 31 mm (with Sleeve) 20 grams
<5 minute/month drift Approximately 30 days Li-ion rechargeable battery, 3.7VDC (nominal), 80mAh,500 recharge cycles Max. 155 mW USB 5VDC, min. 500mA 9VD Communication: Wireless Bluetooth Low Energy (BLE) Tx & Rx freq.: 2400 2800 MHz Max. Tx power:0-4dBm Temperature Accuracy +/- 2 degrees Celsius 10.2 Environment and operating Normal Operation Transport/Storage
-5C to 35C @ 10-75% RH (Non-Condensing)
-5C to 45C @ 10-75% RH (Non-Condensing) Degree of enclosure Vibration/ Shock/
Bump/ Drop/ Free fall IP22 60601-1-11 Pressure 700hPa to 1060hPa 10.3 Electromagnetic compatibility RF Emissions Test Compliance RF emission CISPR 11, IEC 60601-1-2 Group 1, Class B Electromagnetic environment guidance The device RF emissions are not likely to cause interference in nearby electronic equipment. Electromagnetic environment guidance: The device is suitable for use in domestic and home healthcare environments. Immunity Test Test Level 2, 4, and 8 kV contact discharge Compliance level /
performance criterion 8 kV contact discharge 2, 4, 8, 10, 12 and 15 kV air discharge 15 kV air discharge Electrostatic discharge
(ESD) ETSI/EN 301 489-1 ETSI/EN 301 489-17 IEC 60601-1-2 ISO 11608-1 ISO 11608-4 Power frequency magnetic field IEC 60601-1-2 Radiated RF ETSI/EN 301 489-1 ETSI/EN 301 489-17 EN/IEC 60601-1-2 ISO 11608-4 30 A/m 30 A/m 10 V/m 26 MHz 6 GHz Immunity to proximity fields from RF wireless communication equipment as defined in Table 9 of IEC60601-1-2 10 V/m CT for transmitters, CR for receivers Portable RF (radio frequency) communications equipment should be used no closer than 30 cm to any part of the device; otherwise, degradation of the performance of the device could result. InsulCheck DOSE is a Bluetooth device using the 2.4GHz transceiver. In review of IEC 60601-1-2, subclause 8.10 the testing requirements in table 9 for the test frequency 2,450 MHz are acceptable for testing InsulCheck DOSE with the minimum separation distance as 30 cm. There are no foreseeable use cases that would require the InsulCheck DOSE to be used within the 30 cm separation distance. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. 10.4 Accuracy Measurement Accuracy 99%*
* Test bench results. External factors may affect the dose measurement accuracy. 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 CFR 47: part 15 sub part b (FCC ID: 2A9FH-IZDOSE001 see FCC NOTICE below) ANSI 63.4 of 2014 RED Radio Equipment Directive 2014/53/EU FCC (USA) - FCC ID: 2A9FH-IZDOSE001 FCC NOTICE:
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. You are cautioned that changes or modifications not expressly approved by the party responsible for compliance could void your authority to operate the equipment.
1 | Internal Photos | Internal Photos | 715.70 KiB | April 17 2023 / October 14 2023 | delayed release |
1 | external photos | External Photos | 837.62 KiB | April 17 2023 / October 14 2023 | delayed release |
1 | Label | ID Label/Location Info | 957.35 KiB | April 17 2023 |
Technical documentation Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Doc-id IZDOSE-PR-OTH-037 Pages 1(10) Revision 05 DOSE Labelling and Packaging Specification Author, date Signature 2023-03-02 Approved, date Signature 2023-03-02 Clarification of signature Emma Widehll Clarification of signature Dean Minnock Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Doc-id IZDOSE-PR-OTH-037 Pages 2(10) CONTENTS 1 Introduction ......................................................................................................................... 3 1.1 1.2 1.3 1.4 Scope ....................................................................................................................................... 3 Revision history ....................................................................................................................... 3 Definitions ............................................................................................................................... 3 References .............................................................................................................................. 3 2 Unique Label Identifier ......................................................................................................... 4 3 Markings on the outside of the device Device label ............................................................. 4 3.1 3.2 3.3 Elements on Device label ........................................................................................................ 4 Device label size and layout .................................................................................................... 5 Label position .......................................................................................................................... 5 4 Information on the Packaging ............................................................................................... 6 4.1 4.2 4.3 Translations ............................................................................................................................. 6 Elements on Packaging label ................................................................................................... 6 Packaging label size and layout ............................................................................................... 8 5 Packaging details ................................................................................................................ 10 Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Doc-id IZDOSE-PR-OTH-037 Pages 3(10) 1 Introduction 1.1 Scope This report describes the labelling and packaging, for DOSE. 1.2 Revision history Version Approved by 01 02 Approval date 03 04 Dean Minnock Dean Minnock 2022-12-23 2023-01-10 05 Dean Minnock 2023-02-23 06 2023-03-02 Description First version References corrected. Symbol for consulting IFU changed from the version in ISO 15223-1 to the blue man. Added FCC ID number Legal manufacturer address updated on labels. Label position added (chapter 3.3) Updated layout for LBL02 (v05) with separate sticker. Details added on printing and label content. Figures are updated with the V6 of the packaging label. Figure 3 is updated to include the printed label. 1.3 Definitions Term Definition 1.4 References
[1]
[2]
[3]
IZDOSE-LBL01 Device label IZDOSE-LBL02 Packaging label IZDOSE-PR-OTH-047 Packaging with print Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Doc-id IZDOSE-PR-OTH-037 Pages 4(10) 2 Unique Label Identifier The label issue shall be present on the label according to ISO 20417; paragraph 6.1.4 d). The unique label identifier is a combination of the identification number for the device IZDOSE the label identifier LBLXX and the version code XX, starting at 01. For DOSE there are two different labels, the device label and the packaging label. Below are the different unique label identifiers for DOSE labels presented. XX represents the version. Table 1: Overview of Unique label identifiers for DOSE labels. Label type Device label Packaging label Unique label identifier IZDOSE-LBL01-XX IZDOSE-LBL02-XX 3 Markings on the outside of the device Device label 3.1 Elements on Device label The elements to be used on the outside of the device, i.e. on the device label, are presented in Table 2 below. Table 2 Elements to include on the outside of the device. Element ISO 15223-1 5.1.1 Requirement Comment IEC 60601-1, Clause 7.2.2 Manufacturer info (name, trademark, and address) 5.1.6 IEC 60601-1, Clause 7.2.2 Type Reference or Model Version
IEC 60601-1, Clause 7.2.2 Serial number. May be removed if lot or batch identifier is used. IEC 60601-1, Clause 7.2.2 The date of manufacture IEC 60601-1, Clause 7.2.3 Indicates the need for the user to consult the instructions for use. To be accompanied with URL for e-IFU. IEC 60601-1, Clause 7.2.6, 7.2.7 The RATED supply voltage, the nature of supply FCC ID
47 CFR on FCC Legal requirement in the US market Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Doc-id IZDOSE-PR-OTH-037 Pages 5(10) Element ISO 15223-1 Requirement Comment GTIN
ISO 20417, Clause 6.5.2 WEEE, safe disposal information Global trade item number BLE ID Legal requirement on the EU market IEC 60601-1, Clause 7.2.9 IP classification 3.2 Device label size and layout The measurements of the device label [1] is 48,3 mm wide and 8,5 mm high. The device label, IZDOSE-LBL01 has a layout according to Figure 1. Figure 1: Label IZDOSE-LBL01-04 Some of the elements on the label are different depending on when the device is produced and specific device characteristics. These unique items are highlighted with yellow in Figure 2. Figure 2: Unique items, based on manufacturing date and device characteristics. 3.3 Label position The label is a sticker, fastened directly to the Dose device, with position and orientation according to Figure 3. Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Doc-id IZDOSE-PR-OTH-037 Pages 6(10) Figure 3: Position of the label on the device. 4 Information on the Packaging The information elements to be established are presented below. In Section 4.3, an example of how the information may be incorporated in the label is shown. 4.1 Translations Today there are no requirements on translations for the Dose device labels. However, if the device in the future becomes a Medical Device on the European market, all text strings on the label will require translations to local languages (according to GSPR 23.2b). 4.2 Elements on Packaging label The elements to be used on the label are presented in Table 3 below. Table 3 Elements to include on the label. Element ISO 15223-1 5.1.1 Requirement Comment ISO 20417, Clause 6.5.1 Manufacturer info (name and address) 5.1.3 5.1.5 5.1.6 5.1.7 ISO 20417, Clause 6.5.1 Indicates the date when the device was manufactured ISO 20417, Clause 6.5.1 Indicates the manufacturers batch code so that the batch or lot can be identified ISO 20417, Clause 6.5.1 Indicates the manufacturers Catalogue number so that the device can be identified ISO 20417, Clause 6.5.1 Indicates the manufacturers serial number so that a specific device can be identified Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Doc-id IZDOSE-PR-OTH-037 Pages 7(10) Element ISO 15223-1 Requirement Comment 5.2.8 IZDOSE-RMF-010 If the packaging is damaged, the manufacturer cannot ensure the full function of the device. 5.3.2 ISO 20417, Clause 6.5.3 Indicates a device that needs protection from sunlight 5.3.4 ISO 20417, Clause 6.5.3 Indicates a device that needs to be protected from moisture 45C
-5C 5.3.7 5.3.8
Unique Device Identifier (UDI) Necessary contraindications Details necessary to identify the medical device and its use.
(statement of intended use) Commercial product name/
Name or trade name of the device ISO 20417, Clause 6.5.3 Indicates the temperature limits to which the device can be safely exposed ISO 20417, Clause 6.5.3 Indicates the range of humidity to which the device can be safely exposed ISO 20417, Clause 6.1.5 Indicates the need for the user to consult the instructions for use. ISO 20417, Clause 6.5.2 ISO 20417, Clause 6.5.1 ISO 20417, Clause 6.5.2 ISO 20417, Clause 6.1.3 ISO 20417, Clause 6.1.3 and 6.5.1 To be accompanied with URL for e-IFU. WEEE, safe disposal information Identifies the UDI carrier, including the AIDC and human readable information. Legal requirement on the EU market Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Doc-id IZDOSE-PR-OTH-037 Pages 8(10) 4.3 Packaging label size and layout Some items on the label will be specific for each device (e.g. manufacturing date), and to handle this within production, the packaging label is created in two steps. One step is to print the consistent information on the packaging using the layout file Packaging with Print [3] and the second step is to print the device specific information on a small sticker using the layout file Packaging Label [2], and this sticker will be added to the package afterwards, see Figure 4. For a correct placement of the sticker, a grey area is printed in the first step, which the sticker should be added on top of, covering it entirely, see Figure 5. Figure 4: The packaging print with the packaging label integrated. Some information is printed on a separate sticker. Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Doc-id IZDOSE-PR-OTH-037 Pages 9(10) Figure 5: The packaging print after the sticker is added on top of the grey area The separate sticker, IZDOSE-LBL02, contains the fields with date and device specific information. This date and device specific information is explained in Figure 6. The size of IZDOSE-LBL02 is 46x30 mm, and it is positioned on the packaging according to Figure 4.
(01) GTIN NovoPen5: 5391532050133 FlexTouch: 5391532050140 KwikPen: 5391532050164 SoloStar: 5391532050157
(10) Batch or lot number: Up To 20 Char, Num &
Letters, (follow same scheme as CONNECT): This is repeated in the LOT field. a) NP5-YYMM-N b) SS-YYMM-N c) FT-YYMM-N d) KP-YYMM-N
(11) Production date: 6 Char must follow format YYMMDD. Repeated next to symbol for manufacturing.
(17) Expiration date: 6 Char must follow format YYMMDD (1 year from manufacturing date to indicate battery shelf life)
(21) Serial number: Up To 20 Char, Num & Letters This repeated in the SN field Figure 6: Date and device specifics on the packaging label. Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Doc-id IZDOSE-PR-OTH-037 Pages 10(10) 5 Packaging details The packaging for DOSE is a printed cardboard box according to Packaging with print [3]. This file also specifies dimensions of the packaging. The Packaging label is included in the box print as described in Section 4.
1 | Applicant Declaration Letter | Attestation Statements | 190.15 KiB | April 17 2023 |
SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Declaration Applicant Legal Business Name Innovation Zed Ltd. Address Grantee Code FCC ID NovaUCD, Belfield Innovation Park, Belfield, Dublin 4, Ireland 2A9FH 2A9FH-IZDOSE001 Authorized Contact Name Dean Minnock Contact Email Contact Phone deanm@innovationzed.com
+353 83 1508702 I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare;
a) b) in accordance with 47CFR2.911(d), all of the statements herein and the exhibits attached hereto are true and correct to the best of my knowledge and belief. in accepting a Grant of Equipment Authorization issued by a TCB, under the authority of the FCC, as a result of the representations made in this application, the Applicant is responsible for:
labeling the equipment with the exact FCC ID as specified in this application,
(1)
(2) compliance statement labeling pursuant to the applicable rules,
(3) compliance of the equipment with the applicable technical rules, c) d) e) if the Applicant is not the actual manufacturer of the equipment, appropriate arrangements have been made with the manufacturer to ensure that production units of this equipment will continue to comply with the FCCs technical requirements. in accordance with 47 CFR 2.909 and KDB394321, the Applicant has read, understood and agrees to accept that they are the responsible party and agree to abide by their responsibilities as specified under 47 CFR 2.909 and KDB394321. in accordance with ISO 17065, FCC KDB641163, FCC KDB610077, KDB394321 and RSP-100, the Applicant has read, understood, accepts and agrees to abide by the post market surveillance requirements.
(1)
(2)
(3) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. the Applicant shall, upon request by SGS, at the Applicants expense, provide a production sample of the requested product to SGS, FCC and/or ISED as instructed. The sample shall include all support devices, cables, software, accessories or other hardware or software required for evaluation, review, certification and audit surveillance of products certified by SGS. f) g) neither the Applicant nor any party to the application is subject to a denial of Federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862 because of a conviction for possession or distribution of a controlled substance. See 47CFR 1.2002(b) for the definition of a party for these purposes. the Applicant has read, understood, accepts and agrees to abide by the SGS North America, Inc.(TCB) terms and conditions. Link to CFRs: https://www.fcc.gov/wireless/bureau-divisions/technologies-systems-and-innovation-division/rules-regulations-title-47 Link to KDBs: https://apps.fcc.gov/oetcf/kdb/index.cfm Link to RSP-100: https://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01130.html Link to the Covered List: Covered List
[Innovation Zed Ltd. (the applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules.
[Innovation Zed Ltd. (the applicant) certifies that, as of the date of the filing of the application, the applicant [ identified on the Covered list, established pursuant to 1.50002, as an entity producing covered equipment. Applicant Signature:
Date:
Print Name:
Title:
Dean Minnock CEO
*NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database QSF27-14-04 Rev 1.0 Rev. Feb 6, 2023 Page 1 of 1 Original Issue: Jan. 4, 2021 23rd March 2023
1 | Confidentiality Letter | Cover Letter(s) | 77.09 KiB | April 17 2023 |
Date: January 6, 2023 To:
SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia United States From:
Innovation Zed Ltd. NovaUCD, Belfield Innovation Park, Belfield, Dublin 4, Ireland. Regarding:
Confidentiality Request regarding application for FCC ID: 2A9FH-IZDOSE001 LONG TERM CONFIDENTIALITY Pursuant to 47 CFR Section 0.459 and 0.457 of the commissions rules, the applicant hereby request confidential treatment of the documents listed below, associated with the certification application referenced above. Schematic(s) Block Diagrams Operational Descriptions The documents above contain proprietary information not released to the public. Public disclosure of this information may prove harmful to the business of the applicant. SHORT TERM CONFIDENTIALITY Additionally, the applicant requests the following documents be held confidential until the device is marketed or 180 days from the grant date, whichever is less. If the device is marketed within 180 days of the Grant Date, the applicant will notify the TCB per FCC KDB 726920 D01 Confidentiality Request Procedures. External Photos Internal Photos Test Setup Photos User manual(s) Sincerely, Dean Minnock / CEO Innovation Zed Ltd. Phone: +353 83 1508702 E-Mail: deanm@innovationzed.com
1 | Power of Attorney Letter | Cover Letter(s) | 31.50 KiB | April 17 2023 |
TO:
Federal Communication Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MID 21046 Regarding FCC ID: 2A9FH-IZDOSE001 To whom it may concern:
Date: January 6, 2023 We, the undersigned, hereby authorize Kevin Tsai / Deputy Manager of SGS Compliance Certification Services Inc. to act on our behalf in all manners relating to application for equipment authorization with respect to the FCC ID above, including signing of all documents relating to these matters. Any and all acts carried out by the agent on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). Where our agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by SGS North America, Inc., still resides with Innovation Zed Ltd. This authorization is valid until further written notice from the applicant. Dean Minnock / CEO Innovation Zed Ltd. Phone: +353 83 1508702 E-Mail: deanm@innovationzed.com
1 | Test setup photo | Test Setup Photos | 855.99 KiB | April 17 2023 / October 14 2023 | delayed release |
1 | US Agent letter | Attestation Statements | 325.52 KiB | April 17 2023 |
1001 SW Disk Drive, Ste 250 Bend, Oregon 97702 USA fccagent@icertifi.com Tel: +1 (866) 885 4575 www.icertifi.com FCC 22-84 US Agent for Service of Process Contract This Contract for Service is made effective by and between Innovation ZED LTD with a corporate address of NovaUCD, Belfield Innovation Park, Belfield, Dublin 4, Ireland (the recipient), and Americas Compliance Consulting LLC dba iCertifi. with an address of 1001 SW Disk Drive, Suite 250, Bend, Oregon 97702 USA. DESCRIPTION OF SERVICES. Beginning on 31/03/2023, Americas Compliance Consulting LLC dba iCertifi. will provide to the recipient the following services (collectively, the Services). Please choose the level of support required:
OPTION 1: PER CERTIFICATION o Limited to One (1) FCC ID/Model Agent for Service of Process Representative Service o Validity: Permanent FCC ID/Model Number: 2A9FH-IZDOSE001 OPTION 2: UNLIMITED MODELS- 1 Year o Unlimited FCC ID/Model Agent for Service of Process Representative Services o Validity: 1 Year o Note: All models must be developed or sold under the client's name. OPTION 3: UNLIMITED MODELS- 3 Years o Unlimited FCC ID/Model Agent for Service of Process Representative Services o Validity: 3 Years o Note: All models must be developed or sold under the client's name. OPTION 4: UNLIMITED MODELS- 5 Years o Unlimited FCC ID/Model Agent for Service of Process Representative Services o Validity: 5 Years o Note: All models must be developed or sold under the client's name. FCC 22-84 US Agent for Service of Process as outlined within the FCC regulations:
FCC 22-84 986446 D0, section 2.911(d)(7), of Protecting Against National Security Threats to The Communications Supply Chain Through the Equipment Authorization Program states:
Certification designating a U.S. agent for service of process. As required by section 2.911(d)(7), the applicant must designate a contact located in the United States for purposes of acting as the applicants agent for service of process, Proprietary & Confidential Statement: This document and the information disclosed within, including the document structure and contents, are confidential and the proprietary property of iCertifi Global Approvals. LTD. and are protected by patent, copyright and other proprietary rights. Any disclosure to a third party in whole or in part in any manner is expressly prohibited without the prior written permission of iCertifi. 1001 SW Disk Drive, Ste 250 Bend, Oregon 97702 USA fccagent@icertifi.com Tel: +1 (866) 885 4575 www.icertifi.com regardless of whether the applicant is a domestic or foreign entity. An applicant located in the United States may designate itself as an agent for service of process. In either scenario, the designation of the U.S. agent for service of process should be provided as an attachment to the equipment authorization application (the attachment to the equipment authorization application i. Be signed by both the applicant and designated agent for service of process, if the agent is different from the applicant. ii. Acknowledge the applicants consent and the designated agents obligation to accept service of process. iii. Provide a physical U.S. address and email for the designated agent. iv. Acknowledge the applicants acceptance to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. SERVICE TO INCLUDE. Americas Compliance Consulting LLC dba iCertifi will respond to all FCC enquiries and requests in reference to FCC 22-84 986446 D0 to ensure compliance to these regulations. iCertifi also will provide a physical U.S. address and email to the foreign manufacturer and a compliant Attestation Letter. 1. RESPONSIBILITY OF AMERICAS COMPLIANCE CONSULTING LLC DBA ICERTIFI. iCertifi. shall provide the recipient with an Attestation Letter signed by the authorized officer of iCertifi which will be valid for the period outlined within the selected service option on page one of this agreement. TERMS OF CONTRACT. Depending on the service option selected, this contact will terminate automatically as follows:
Option 1: Permanent Validity with no termination date. Option 2: Upon the 1-year anniversary date of the executed contract date. Option 3: Upon the 3-year anniversary date of the executed contract date. Option 4: Upon the 5-year anniversary date of the executed contract date. 5. DEFAULT. The occurrence of any of the following shall constitute a material default under this contract:
The failure to make the required payment when due. The insolvency or bankruptcy of either party. The failure to provide support within the timeframe requested by FCC. 6. ATTORNEYS FEES AND COLLECTION COSTS. If there is a dispute relating to any provisions in this contract, the prevailing party is entitled to, and the non-prevailing party shall pay, the cost and expenses incurred by the prevailing party in the dispute, including but not limited to all out-of-pocket costs of collection, court costs, and reasonable attorney fees and expenses 7. REMEDIES. In addition to all other rights a party might have available according to law, if a party defaults by failing to substantially perform any provision, term or condition of this contract, (including without limitation the failure to make a monetary payment when due), the other party may terminate the contract by providing written notice to the defaulting party. This notice shall describe with sufficient detail the nature of the default. The party receiving such notice shall have 30 days from the effective date of such notice to cure the default(s). Unless waived in writing by a party providing Proprietary & Confidential Statement: This document and the information disclosed within, including the document structure and contents, are confidential and the proprietary property of iCertifi Global Approvals. LTD. and are protected by patent, copyright and other proprietary rights. Any disclosure to a third party in whole or in part in any manner is expressly prohibited without the prior written permission of iCertifi. 1001 SW Disk Drive, Ste 250 Bend, Oregon 97702 USA fccagent@icertifi.com Tel: +1 (866) 885 4575 www.icertifi.com 8. FORCE MAJURE. If performance of this contract or any obligation under this contract is prevented, restricted, or interfered with by cause beyond either partys reasonable control, (Force Majeure), and if the party unable to carry out its obligations gives the other party prompt written notice of such event, then the obligations of the party invoking this provision shall be suspended to the extent necessary by such event. The term Force Majeure shall include, without limitation, acts of God, plague, epidemic, pandemic, outbreaks of infectious disease or any other public health crisis, including quarantine or other employee restrictions, fire, explosion, vandalism, storm or other similar occurrence, orders of acts of military or civil authority, or by national emergencies, insurrections, riots, or wars, or strikes, lockouts, work stoppages or other labor disputes, or supplier failures. The excused party shall use reasonable efforts under the circumstances to avoid or remove such causes of non-performance and shall proceed to perform with responsible dispatch whenever such causes are removed or ceased. An act or omission shall be deemed within the reasonable control of a party if committed, omitted, or caused by such party, or its employees, officers, agents, or affiliates. 9. DISPUTE RESOLUTION. The parties will attempt to resolve any dispute arising out of or relating to this Agreement through friendly negotiations amongst the parties. If the manner is not resolved by negotiations within 30 days, the parties will resolve the dispute using the below Alternative Dispute Resolution (ADR) procedure. Any controversies or disputes arising out of or relating to this Agreement will be resolved by binding arbitration under the rules of the United States Arbitration Act. The arbitrators award will be final, and judgement may be entered upon it by any court having proper jurisdiction. 10. ENTIRE AGREEMENT. This contract contains the entire agreement of the parties, and there are no other promises or conditions in any other agreement whether oral or written concerning the subject matter of this contract. This contract supersedes any prior written or oral agreement between parties. 11. SEVERABILITY. If any provisions of this contract will be held to be invalid or unenforceable for any reason, the remaining provisions will continue to be valid and enforceable. If a court finds that any provision of this contract is invalid or unenforceable, but that the limiting such provision it would become valid and enforceable, then such provisions will be deemed to be written, construed, and enforced as so limited. 12. AMENDMENT. This contract may be modified or amended in writing by mutual agreement between the parties, if the writing is signed by the party obligated under the amendment. 13. GOVERNING LAW. This contract shall be construed in accordance with the laws of the State of Oregon within the United States. 14. NOTICE. Any notice or communication required or permitted under this contract shall be sufficiently given if delivered in person or by certified mail, return receipt requested, to the address set forth in the opening paragraph or to such other address as one party may have furnished to the other in writing. 15. WAIVER OF CONTRACTUAL RIGHTS. The failure of either party to enforce any provision of this Contract shall not be construed as a waiver or limitation of that partys right to subsequently enforce and compel strict compliance with every provision of this contract. 16. ATTORNEYS FEES TO PREVAILING PARTY. In any action arising hereunder or any separate action pertaining to the validity of this Agreement, the prevailing party shall be awarded reasonable attorneys fees and costs, both in the trial court and on appeal. 17. CONSTRUCTION AND INTERPRETATION. The rule requiring construction or interpretation against the drafter is waived. The document shall be deemed as if it were drafted by both parties in mutual effort. Proprietary & Confidential Statement: This document and the information disclosed within, including the document structure and contents, are confidential and the proprietary property of iCertifi Global Approvals. LTD. and are protected by patent, copyright and other proprietary rights. Any disclosure to a third party in whole or in part in any manner is expressly prohibited without the prior written permission of iCertifi. 1001 SW Disk Drive, Ste 250 Bend, Oregon 97702 USA fccagent@icertifi.com Tel: +1 (866) 885 4575 www.icertifi.com 18. ASSIGNEMENT. Neither party may assign or transfer this contract without the prior written consent of the non-
assigning party, which approval shall not be unreasonably withheld. IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by their duly authorized representatives as of the date first above written. Date: 31/03/2023 America Compliance Consulting LLC dba iCertifi Paul Preston President/CEO Company: Innovation Zed LTD Name: Dean Minnock CEO Title:
Proprietary & Confidential Statement: This document and the information disclosed within, including the document structure and contents, are confidential and the proprietary property of iCertifi Global Approvals. LTD. and are protected by patent, copyright and other proprietary rights. Any disclosure to a third party in whole or in part in any manner is expressly prohibited without the prior written permission of iCertifi.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-04-17 | 2402 ~ 2480 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2023-04-17
|
||||
1 | Applicant's complete, legal business name |
Innovation Zed LTD
|
||||
1 | FCC Registration Number (FRN) |
0033080623
|
||||
1 | Physical Address |
NovaUCD, Belfield Innovation Park, Belfield
|
||||
1 |
NovaUCD, Belfield Innovation Park
|
|||||
1 |
Dublin 4, N/A
|
|||||
1 |
Ireland
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
U******@SGS.COM
|
||||
1 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
2A9FH
|
||||
1 | Equipment Product Code |
IZDOSE001
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
D******** M********
|
||||
1 | Title |
Dr
|
||||
1 | Telephone Number |
08315********
|
||||
1 | Fax Number |
+3538********
|
||||
1 |
d******@innovationzed.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 10/14/2023 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DTS - Digital Transmission System | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | InsulCheck DOSE | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | Power output listed is conducted. The antenna used for this transmitter must not be co-located or operating in configuration with any other antenna or transmitter. End-users must be provided with transmitter operating conditions for satisfying RF exposure compliance. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Compliance Certification Services Inc. Wugu Lab.
|
||||
1 | Name |
H******** L******
|
||||
1 | Telephone Number |
886-2******** Extension:
|
||||
1 | Fax Number |
+886-********
|
||||
1 |
h******@sgs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 | 0.0002900 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC