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2A9FH-IZDOSE001InsulCheck DOSE

Innovation Zed LTD
InsulCheck DOSE - FCC ID 2A9FH-IZDOSE001 - Innovation Zed LTD
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Application Details

Equipment Class
DTS - Digital Transmission System
Date of Grant
Apr 16, 2023
Application Purpose
Original Equipment
Date of Application
Apr 16, 2023
Equipment Note
InsulCheck DOSE
Frequency Range
2402.00000000 - 2480.00000000
Company
Innovation Zed LTD
Country
Ireland

Documents & Files

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Users Manual

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Attestation Statements

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Cover Letter(s)

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External Photos

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ID Label/Location Info

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Internal Photos

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RF Exposure Info

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Test Report

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Test Setup Photos

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Document Text

Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.

Users Manual

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 [email protected] 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. IMPORTANT Read all instructions and warnings before use. Table of Contents Contents 1 Introduction 7 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 9 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 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 25 4.1 General cleaning ........................... 25 4.2 Sensor Cleaning ........................... 25 5 Disposal 26 6 General safety advice 27 7 Troubleshooting 28 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 31 9 Contact information 33 9.1 Support ....................................... 33 9.2 Manufacturer ............................... 33 9.3 Warranty ..................................... 33 9.4 Disclaimers .................................. 33 10 Technical specifications 34 10.1 Specifications ............................. 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 provider’s 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 Blueto…

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Attestation Statements

Applicant Declaration QSF27-14-04 Rev 1.0 Rev. Feb 6, 2023 Page 1 of 1 Original Issue: Jan. 4, 2021 SGS North America Inc. 620 Old Peachtree Road SUITE 100 Suwanee, Georgia 30024 United States Applicant Legal Business Name Innovation Zed Ltd. Address NovaUCD, Belfield Innovation Park, Belfield, Dublin 4, Ireland Grantee Code 2A9FH FCC ID 2A9FH-IZDOSE001 Authorized Contact Name Dean Minnock Contact Email [email protected] Contact Phone +353 83 1508702 I, the undersigned, certify that I am an authorized signatory for the Applicant and therefore declare; a) 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. b) 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: (1) labeling the equipment with the exact FCC ID as specified in this application, (2) compliance statement labeling pursuant to the applicable rules, (3) compliance of the equipment with the applicable technical rules, c) 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 FCC’s technical requirements. d) 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. e) 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) the Applicant understands, accepts and agrees that a sample may be requested for surveillance testing. (2) the Applicant shall make provisions to always have a production sample available upon request by SGS, FCC and/or ISED. (3) the Applicant shall, upon request by SGS, at the Applicant’s 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) 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. g) 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: Dean Minnock Title: CEO *NOTE: This declaration cannot be signed by an Agent, it shall be signed by an authorized person listed in the FCC database 23rd March 2023

Attestation Statements

Innovation Zed Ltd. Registered in Dublin Ireland – Registration No. 469011 Directors: John Hughes, William Cirillo, Gabor Papp (Hungary), Page 1 of 1 V02072023 Innovation Zed Ltd. NovaUCD Belfield Innovation Park Belfield Dublin 4 Ireland Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 03/31/2023 Ref: Attestation Statement Part 2.911(d)(7) Filing Validity Period: Permanent FCC ID: 2A9FH-IZDOSE001 Innovation Zed Ltd. certifies that, as of the dates of this application, Americas Compliance Consulting LLC dba iCertifi “iCertifi” is our designated U.S. agent for service of process for the above referenced FCC ID. We accept 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. The US Agent for Service of Process is aware of and agrees to comply with the requirements outlined in the FCC Equipment Authorization Program, Report and Order FCC 22-84, and clause § 2.911. iCertifi accepts, as of the date of the filing of the application, the obligation of the designated U.S. agent for service process for the above: Designated U.S. Agent Information: Name Americas Compliance Consulting, LLC dba iCertifi FCC FRN 0033399411 Address 1001 SW Disk Drive, Suite 250 Bend, Oregon 97702 USA Contact Person Paul Preston Telephone (866 ) 885-4575 Email [email protected] Sincerely, Manufacturer Name Innovation Zed LTD Manufacturer Contact Dean Minnock – [email protected] Signature

Attestation Statements

1001 SW Disk Drive, Ste 250 Bend, Oregon 97702 USA [email protected] Tel: +1 (866) 885 4575 www.icertifi.com 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. 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 applicant’s agent for service of process, 1001 SW Disk Drive, Ste 250 Bend, Oregon 97702 USA [email protected] Tel: +1 (866) 885 4575 www.icertifi.com 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. 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 applicant’s consent and the designated agent’s obligation to accept service of process. iii. Provide a physical U.S. address and email for the designated agent. iv. Acknowledge the applicant’s 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. ATTORNEY’S 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 defau…

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Cover Letter(s)

Date: January 6, 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: 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: [email protected]

Cover Letter(s)

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 commission’s 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: [email protected]

External Photos

This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可,不可部份複製。 Project No: TM-2207000359P Page: 1 / 9 Rev.: 01 APPENDIX 1 - PHOTOGRAPHS OF EUT EXTERNAL PHOTOGRAPHS OF EUT This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可,不可部份複製。 Project No: TM-2207000359P Page: 2 / 9 Rev.: 01 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可,不可部份複製。 Project No: TM-2207000359P Page: 3 / 9 Rev.: 01 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可,不可部份複製。 Project No: TM-2207000359P Page: 4 / 9 Rev.: 01 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可,不可部份複製。 Project No: TM-2207000359P Page: 5 / 9 Rev.: 01

ID Label/Location Info

Technical documentation Doc-id IZDOSE-PR-OTH-037 Pages 1(10) Document name IZDOSE-PR-OTH-037 Labelling and Packaging Specification v6 Revision 05 DOSE Labelling and Packaging Specification Author, date Signature Clarification of signature 2023-03-02 Emma Widehäll Approved, date Signature Clarification of signature 2023-03-02 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 Scope ....................................................................................................................................... 3 1.2 Revision history ....................................................................................................................... 3 1.3 Definitions ............................................................................................................................... 3 1.4 References .............................................................................................................................. 3 2 Unique Label Identifier ......................................................................................................... 4 3 Markings on the outside of the device – Device label ............................................................. 4 3.1 Elements on Device label ........................................................................................................ 4 3.2 Device label size and layout .................................................................................................... 5 3.3 Label position .......................................................................................................................... 5 4 Information on the Packaging ............................................................................................... 6 4.1 Translations ............................................................................................................................. 6 4.2 Elements on Packaging label ................................................................................................... 6 4.3 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 Approval date Description 01 First version 02 References corrected. Symbol for consulting IFU changed from the version in ISO 15223-1 to “the blue man”. 03 Dean Minnock 2022-12-23 Added FCC ID number 04 Dean Minnock 2023-01-10 Legal manufacturer address updated on labels. Label position added (chapter 3.3) 05 Dean Minnock 2023-02-23 Updated layout for LBL02 (v05) with separate sticker. Details added on printing and label content. 06 2023-03-02 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] IZDOSE-LBL01 Device label [2] IZDOSE-LBL02 Packaging label [3] 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 Unique label identifier Device label IZDOSE-LBL01-XX Packaging label 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 Requirement Comment 5.1.1 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 - ISO 20417, Clause 6.5.2 WEEE, safe disposal information GTIN - 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…

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Internal Photos

This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可,不可部份複製。 Project No: TM-2207000359P Page: 6 / 9 Rev.: 01 INTERNAL PHOTOGRAPHS OF EUT This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可,不可部份複製。 Project No: TM-2207000359P Page: 7 / 9 Rev.: 01 This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可,不可部份複製。 Project No: TM-2207000359P Page: 8 / 9 Rev.: 01 RF IC & Crystal Antenna This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可,不可部份複製。 Project No: TM-2207000359P Page: 9 / 9 Rev.: 01 Battery

RF Exposure Info

This document cannot be reproduced except in full, without prior written approval of the Company. 本報告未經本公司書面許可,不可部份複製。 Project No: TM-2207000359P Page 1 / 1 Report No.: TMWK2210004351KS Rev. 00 FCC ID: 2A9FH-IZDOSE001 According to 447498 D01 General RF Exposure Guidance v06 section 4.3.1, the 1-g SAR test exclusion thresholds at test separation distance ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] *·[√f(GHz)] ≤ 3.0 The tune-up power is 1 dBm +/- 0.5dB, therefore the highest tune-up power is -5.0 dBm(0.32 mW)@ 2480 MHz When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion. So, (0.32mW / 5mm)* (2.480GHz^0.5 )= 0.1 [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] * [√f(GHz)] = 0.1 < 3.0 Therefore, standalone SAR measurements are not required for both head and body. Note: 1. The tune up power referred the AVG power of the test report TMWK2207002979KR for SAR test exclusion purpose.

Test Report

Project No: TM-2207000359P Page 1 / 69 Report No.: TMWK2207002979KR Rev. 00 No.11, Wugong 6th Rd., Wugu Dist., New Taipei City , Taiwan /新北市五股區五工六路11號 t:(886-2) 2299-9720 f:(886-2) 2299-9721 www.sgs.com.tw Unless otherwise stated the results shown in this test report refer only to the sample(s) tested and such sample(s) are retained for 90 days only. 除非另有說明,此報告結果僅對測試之樣品負責,同時此樣品僅保留90天。本報告未經本公司書面許可,不可部份複製。 This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at http://www.sgs.com.tw/Terms-and-Conditions and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at http://www.sgs.com.tw/Terms-and-Conditions. Attention is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this document is advised that information contained hereon reflects the Company’s findings at the time of its intervention only and within the limits of client’s instruction, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction from exercising all their rights and obligations under the transaction documents. This document cannot be reproduced, except in full, without prior written approval of the Company…

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Contact Information

Applicant

Dean Minnock(Dr)
[email protected]0831508702Fax: +353831508702

Test Firm

Compliance Certification Services Inc. Wugu Lab.Hank Lee
[email protected]886-2-2299-9720Fax: +886-2-2299-9721

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz290.00 µW
Confidentiality
Long Term
Grant Notes
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.