
Text extracted from the exhibit documents filed with the FCC. Open a document above to read the original.
Page 1 of 31 INSTRUCTIONS FOR USE MANUAL ZywieZ3 ECG Monitor Instructions for Use Manual Page 2 of 31 The precautionary instructions for user found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definitions of these symbols are as follows: CAUTION - Text with a “CAUTION” indicator will explain possible Safety infractions that could have the potential to cause minor to moderate injury or damage to equipment. WARNING - Text with a “WARNING” indicator will explain possible Safety infractions that will potentially cause serious injury and equipment damage. DANGER - Text with a “DANGER” indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury. NO SITTING - Text with a “NO SITTING” indicator will explain possible Safety infractions that will potentially cause injury and equipment damage. NO STEPPING ON SURFACE - Text with a “NO STEPPING ON SURFACE” indicator will explain possible safety infractions that will cause equipment damage. NOTE: Throughout this manual, “NOTE” may be found. These NOTEs are helpful information to aid in the particular area or function being described Manufactured by Johari Digital Healthcare Ltd. G-582-584, EPIP Boranada, 342012, Jodhpur (Raj.) Mail: [email protected] Web: www.joharidigital.com Manufactured for Zywie, Inc. 12000 Findley Road, Suite 360, Johns Creek, GA 30097 Mail: [email protected] Web: www.zywie.healthcare Page 3 of 31 Table of Contents 1 Instructions for Use ........................................................................................................................................ 4 1.1 Warnings ................................................................................................................................................... 4 1.2 Contraindications ................................................................................................................................... 5 1.3 Precautions for ZywieZ3 sensor ....................................................................................................... 5 1.4 Precautions for ZywieZ3 disposable adhesive ............................................................................ 5 1.5 Precautions for ZywieZ3 docking station ........................ 1.6 Possible Adverse Effects ...................................................................................................................... 5 1.7 Patient Consultation and Informed Consent ............................................................................... 6 2 Introduction/Operation ................................................................................................................................ 7 3 Device Description ........................................................................................................................................ 9 4 Accessories ..................................................................................................................................................... 11 5 Specification ................................................................................................................................................... 13 6 Safety & Regulatory .................................................................................................................................... 14 7 Clinical Application ...................................................................................................................................... 22 8 Controls & Functions .................................................................................................................................. 23 9 Application Operation ................................................................................................................................ 25 10 Troubleshooting ...................................................................................................................................... 27 11 Maintenance .............................................................................................................................................. 28 12 Warranty ..................................................................................................................................................... 29 Page 4 of 31 1 Instructions for Use ZywieZ3 Sensor is a wireless device intended for use by healthcare professionals for recording and display of physiological data in outpatient settings. The physiological electrocardiogram (ECG) data is transmitted wirelessly to a cellular device for storage, display, and transmission. The ZywieZ3 sensor can be configured by authorized persons to modify or merge or ignore any of the operational alerts, but not to set alerts related to physiological data. 1.1 Warnings 1.1.1. Do not treat patients without physician evaluation. Safety of device during pregnancy or delivery has not been established. 1.1.2. Do not treat over swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins). 1.1.3. Do not wear or use the sensor during magnetic resonance imaging (MRI), or electro-cautery procedures. The ZywieZ3 sensor is MR Unsafe. 1.1.4. Exposure of the wireless communications features of the device, or its accessories, may be interfered with by other devices that operate on the same frequencies. 1.1.5. Excessive body tissue, hair, or dry skin may affect the signal quality. 1.1.6. In case of skin discomfort, remove the sensor immediately. 1.1.7. For best results, the sensor must be used with the provided adhesives. 1.1.8. No servicing/maintenance is required while the device is in use. 1.1.9. Before every use, check the device. Do not use the device if it is damaged. The continuous use of a damaged unit may cause improper results. 1.1.10. The de…
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www.zywie.healthcare Phone: 877.858.7200 Fax: 678-514-3609 12000 Findley Road Suite 360 Johns Creek, GA 30097 USA Applicant as U.S. Agent Letter of Attestation Date: 04-05-2023 To: Federal Communications Commission 7435 Oakland Mills Road, Columbia, MD 21046, USA Ref: Attestation Statement – Part 2.911(d)(7) filing FCC ID: 2BAK3Z3E Zywie, Inc. (“t he applicant”) as required by section 2.911(d)(7), will also serve as the agent for service of process for the above referenced FCC ID. The applicant acknowledges that they will 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 administrative or judicial proceeding involving the equipment, whichever is later. The applicant further acknowledges their responsibility to inform the FCC whenever the agent information changes. Designated U.S. Agent from Applicant Company Company Name: Zywie, Inc. Contact Person: Latha Ganeshan Address: 12000 Findley Road, St. 360, Johns Creek, GA 30097, USA Tel.: 678-514-3158 Email: [email protected] FCC FRN: 0033539271 Sincerely yours, Signature Printed Name: Latha Ganeshan Title: CEO Email: [email protected]
www.zywie.healthcare Phone: 877.858.7200 Fax: 678-514-3609 12000 Findley Road Suite 360 Johns Creek, GA 30097 USA Attestation Statements Not Covered Entity Applicant & Not Covered Equipment To: Federal Communications Commission Date: 03-29-2023 7435 Oakland Mills Road, Columbia, MD 21046, USA Ref: Information Required by Section 2.911(d)(5)(i) & (ii) FCC ID: 2BAK3Z3E Zywie, Inc. (“the applicant”) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List, established pursuant to § 1.50002 of reference chapter, as an entity producing “covered” communication equipment. The equipment for which authorization is sought is not “covered” telecommunications equipment and video surveillance equipment produced by entities identified on the Commission’s Covered List that prohibited from receiving an equipment authorization pursuant to section § 2.903 of the FCC rules. Sincerely yours, Applicant Signature Printed Name: Latha Ganeshan Title: CEO Address: 12000 Findley Road Suite 360, Johns Creek, GA 30097, USA Tel.: 678-514-3158 Email: [email protected]
www.zywie.healthcare Phone: 877.858.7200 Fax: 678-514-3609 12000 Findley Road Suite 360 Johns Creek, GA 30097 USA Attestation Statements Not Covered Entity Applicant & Not Covered Equipment To: Federal Communications Commission Date: 03-29-2023 7435 Oakland Mills Road, Columbia, MD 21046, USA Ref: Information Required by Section 2.911(d)(5)(i) & (ii) FCC ID: 2BAK3Z3E Zywie, Inc. (“the applicant”) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List, established pursuant to § 1.50002 of reference chapter, as an entity producing “covered” communication equipment. The equipment for which authorization is sought is not “covered” telecommunications equipment and video surveillance equipment produced by entities identified on the Commission’s Covered List that prohibited from receiving an equipment authorization pursuant to section § 2.903 of the FCC rules. Sincerely yours, Applicant Signature Printed Name: Latha Ganeshan Title: CEO Address: 12000 Findley Road Suite 360, Johns Creek, GA 30097, USA Tel.: 678-514-3158 Email: [email protected]
www.zywie.healthcare Phone: 877.858.7200 Fax: 678-514-3609 12000 Findley Road Suite 360 Johns Creek, GA 30097 USA Authority to Act as Agent Date: 04-03-2023 TUV Rheinland of North America, Inc. 1279 Quarry Lane., Suite. A Pleasanton, CA 94566 To Whom It May Concern: I appoint Mr Raghavendra Kulkarni to act as our agent in the preparation of this application for equipment certification. I certify that the submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the FCC or Industry Canada’s regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized 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 TUV Rheinland Group, still resides with Zywie, Inc., 12000 Findley Road, St. 360, Johns Creek, GA 30097, USA. For TCB applications, We certify that we are not subject to 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. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you, Agency Agreement Date: 04-03-2023 The agreement is valid for 12 months from the above date. By: __________________________ Latha Ganeshan (Signature) (Print name) CEO 678-514-3158 (Title) (Telephone) On behalf of: Zywie,Inc. (Company Name)
www.zywie.healthcare Phone: 877.858.7200 Fax: 678-514-3609 12000 Findley Road Suite 360 Johns Creek, GA 30097 USA Confidentiality Letter Date: April 3, 2023 Subject: Confidentiality Request for FCC ID: 2BAK3Z3E Pursuant to FCC 47 CRF 0.457(d) and 0.459, the applicant requests that a part of the subject FCC application be held confidential. Type of Confidentiality Requested Exhibit Short Term Permanent Block Diagrams Short Term Permanent External Photos Short Term Permanent Internal Photos Short Term Permanent Operation Description/Theory of Operation /NII software security attestation Short Term Permanent Part List/Tune-Up Procedure Short Term Permanent Schematics Short Term Permanent Test Setup Photos Short Term Permanent User’s Manual Zywie, Inc. has spent substantial effort in developing this product and it is one of the first of its kind in the industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from the public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality: The applicant requests the exhibits selected above as short-term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid the premature release of sensitive information prior to marketing or the release of the product to the public. The applicant is also aware that they are responsible to notify TUV Rheinland in the event information regarding the product or the product is made available to the public. TUV Rheinland will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. Sincerely, Latha Ganeshan/ CEO, Zywie, Inc. By: (Signature) (Print name//Title)
Produkte Products www.tuv.com EUT External Photos Reference Test Report No: IN22G8KZ 001 Seite 1 von 5 Page 1 of 5 EUT EXTERNAL PHOTOS EUT Front View EUT Rear View Produkte Products www.tuv.com EUT External Photos Reference Test Report No: IN22G8KZ 001 Seite 2 von 5 Page 2 of 5 Adhesive rear view Adhesive Front View Produkte Products www.tuv.com EUT External Photos Reference Test Report No: IN22G8KZ 001 Seite 3 von 5 Page 3 of 5 EUT Dimensional View EUT Dimensional View Produkte Products www.tuv.com EUT External Photos Reference Test Report No: IN22G8KZ 001 Seite 4 von 5 Page 4 of 5 EUT Dimensional View Docking station rear dimensional view Produkte Products www.tuv.com EUT External Photos Reference Test Report No: IN22G8KZ 001 Seite 5 von 5 Page 5 of 5 Docking station front dimensional view
www.zywie.healthcare Phone: 877.858.7200 Fax: 678-514-3609 12000 Findley Road Suite 360 Johns Creek, GA 30097 USA Zywie Sensor Zywie Docking Station FCC Label & Location For Authorised Signatory Only Sign & Date Name: Latha Ganeshan Title: CEO 04-03-2023
Produkte Products www.tuv.com EUT Internal Photos Reference Test Report No: IN22G8KZ 001 Seite 1 von 2 Page 1 of 2 EUT INTERNAL PHOTOS PCB front View PCB_Rear View Produkte Products www.tuv.com EUT Internal Photos Reference Test Report No: IN22G8KZ 001 Seite 2 von 2 Page 2 of 2 PCB Dimensional View
2450 MHz Small SMD Chip AntennaP/N 2450AT42B100 Ground Clearance Requirements Minimized. This antenna was designed for corner or end-mounting Detail Specification: 10/08/13 Page 1 of 4 Inmm No. L ±± 1 W ±± 2 L1 ±± 3 W1 ±± 4 T a ±± Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver 2.1 2013 Johanson Technology, Inc. All Rights Reserved Note: It is recommended that the designer leave available slots for a "pi" (or shunt-series- shunt) network. The antenna matching network values here are used when antenna is mounted on Johanson's evaluation board. The matching values on clinet's PCB will be different, go to: johansontechnology.com/tuning and see how to obtain the new values. If you need further help, contact our RF Applications Eng Team at: www.johansontechnology.com/en/ask-a-technical-question.html We peform layout review as well as antenna tuning and characterization services. Go to page 2 for details. General Specifications -40 to +85°C 2W max. (CW) 2,000 50 Ω 9.5 dB min. -1.5 dBi typ. (XZ-V) 0 dBi typ. (XZ-V) 2400 - 2500 Mhz 0.0200.0120.500.30 0.0792.00+.004/-.008+0.1/-0.2 0.0080.20 0.50 0.0080.20 2.600.20 +5 ~ +35 °C,Humidity 45~75%RH -40 to +85°C "High Frequency Ceramic Solutions" 0.20 2.00 0.020 0.1020.008 0.008 0.197 0.079 5.00 NC NC NC 2450AT42B100 Mounting Considerations Part Number Frequency Range Peak Gain Average Gain Return Loss Impedance Reel Quanity Power Capacity Function Mechanical DimensionsTerminal Configuration Feeding Point Operating Temperature Recommended Storage Condition Storage Period a T W1 L1 W L 2.810.71 1 0.7 1.0 3 0.7 0.8 2 0.7 1 22 8 3.8 6 3.3 nH 1.5 nH Line width should be designed to match 50Ωcharacteristic impedance (Grounded Co‐Planar Waveguide), depending on PCB material and thickness. (The matching circuit and component values will be different on clients PCB layout, se notes below and go to page 2 for details). Top View Bottom View Side View Yellow area=Ground/Metal Clearance. The "0.82mm" dimmension is a min. requirement, if the designer can make this larger, the better radiation and gain will occur (i.e. 2.0 or 4.0mm) RF Via"stich" around antenna clearance and feed trace for best radiation 2450 MHz Small SMD Chip AntennaP/N 2450AT42B100 Detail Specification: 10/08/13 Page 2 of 4 Test Board: P/N: 2450AT42B100-EB1SMA (orderable item) To order, go to: www. johansontechnology.com/samplerequest Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver 2.1 2013 Johanson Technology, Inc. All Rights Reserved Typical Electrical Characteristics (T=25 o C) We offer antenna layout review, tuning, and characterization services, go to: www.johansontechnology.com/ipcantennaservices for details and instructions Johanson Evaluation Board (orderable item) "High Frequency Ceramic Solutions" 3.86 40 20 8 (Units in mm) Return Loss (with matching) This 50ΩFeedline can be as short as needed, this lenth is just for reference to our EVB 2450 MHz Small SMD Chip AntennaP/N 2450AT42B100 Detail Specification: 10/08/13 Page 3 of 4 Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver 2.1 2013 Johanson Technology, Inc. All Rights Reserved Typical Electrical Characteristics (T=25 o C) Radiation Patterns "High Frequency Ceramic Solutions" XY-V/XY-H 180 o 270 o 0 o 90 o X Z Y XY-cut scanning directio n XZ-V/XZ-H 180 o 270 o 0 o 90 o X Z Y XZ-cut scanning directio n YZ-V/YZ- H 180 o 270 o 0 o 90 o X Z Y YZ-cut scanning directio n XY cut @2.45GHz Vertical Horizontal XZ cut @2.45GHz Vertical Horizontal YZ cut @2.45GHz Vertical Horizontal 2450 MHz Small SMD Chip AntennaP/N 2450AT42B100 Detail Specification: 10/08/13 Page 4 of 4 Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver 2.1 2013 Johanson Technology, Inc. All Rights Reserved www.johansontechnology.com/technical-notes/rohs-compliance.html RoHS Compliance MSL Info www.johansontechnology.com/technical-notes/msl-rating.html www.johansontechnology.com/ipcantennaservices "High Frequency Ceramic Solutions" Part Number Explanation P/N Suffix Packing Style Bulk (loose pieces)Suffix = Seg.2450AT42B100S T & RSuffix = Eeg. 2450AT42B100E Temperature:+5C to +35°CShelf Life: 18 months max. T & R (Reverse)Suffix = Reg. 2450AT42B100R (MOQ Applies) 100% TinSuffix = None eg. 2450AT42B100(S, E, R) Eval Board (1-port SMA antenna test boards) 2450AT42B100-EB1SMA (Page 2) More Details www.johansontechnology.com/ipc-pn-explained Storage Conditions and Shelf Life (On T&R or Bulk) Relative Humidity: 45 to 75% Packaging information Soldering Information Antenna layout and tuning techniques www.johansontechnology.com/ipcsoldering-profile www.johansontechnology.com/ipcpackaging.html Antenna layout review, tuning, and characterization services www.johansontechnology.com/tuning
Prüfbericht – Produkte Test Report - Products Prüfbericht-Nr.: Test report no.: IN22G8KZ 001 Auftrags-Nr.: Order no.: 146747176 0010 Seite 1 von 3 Page 1 of 3 Kunden-Referenz-Nr.: Client reference no.: 2288216 Auftragsdatum: Order date: 2022-12-19 Auftraggeber: Client: Zywie, Inc 12000 Findley Road, Suite 360, Johns Creek, GA-30097, USA Prüfgegenstand: Test item: ZywieZ3™ Sensor & Adhesive Bezeichnung Identification Z31000016 Serien -Nr.: Serial no.: PRT0036 Auftrags-Inhalt: Order content: Testing and issue of Test Report with Grant Certificate Prüfgrundlage: Test specification: FCC 1.1310 Wareneingangsdatum: Date of sample receipt: 2022-12-20 Prüfmuster-Nr.: Test sample no: A003392716-001 & A003392716-002 Prüfzeitraum: Testing period: 2022-12-20 - 2022-12-28 Ort der Prüfung: Place of testing: Wireless laboratory, Bangalore Prüflaboratorium: Testing laboratory: TÜV Rheinland (India) Pvt. Ltd. 27/B,2nd cross road, Electronic city Phase1, Banglore-560100, India FCC Test Site Registration No: 496599 IC Test Site Registration No: 3466E-1 Prüfergebnis*: Test result*: Pass geprüft von: tested by: genehmigt von: authorized by: Datum: Date: 2023-01-20 Ausstellatum: Issue date: 2023-04-06 Stellung / Position: M.V.Naveen Kumar Engineer Stellung / Position: Madhu K.N Senior Engineer Sonstiges / Other: FCC ID: 2BAK3Z3E Zustand des Prüfgegenstandes bei Anlieferung: Condition of the test item at delivery: Prüfmuster vollständig und unbeschädigt Test item complete and undamaged * Legende: 1 = sehr gut 2 = gut 3 = befriedigend 4 = ausreichend 5 = mangelhaft P(ass) = entspricht o.g. Prüfgrundlage(n) F(ail) = entspricht nicht o.g. Prüfgrundlage(n) N/A = nicht anwendbar N/T = nicht getestet * Legend: 1 = very good 2 = good 3 = satisfactory 4 = sufficient 5 = poor P(ass) = passed a.m. test specification(s) F(ail) = failed a.m. test specification(s) N/A = not applicable N/T = not tested Dieser Prüfbericht bezieht sich nur auf das o.g. Prüfmuster und darf ohne Genehmigung der Prüfstelle nicht auszugsweise vervielfältigt werden. Dieser Bericht berechtigt nicht zur Verwendung eines Prüfzeichens. This test report only relates to the a. m. test sample. Without permission of the test center this test report is not permitted to be duplicated in extracts. This test report does not entitle to carry any test mark. TÜV Rheinland (India) Pvt. Ltd, Plot No.27/B, 2nd Cross, Electronic city, Industrial Area, Phase I, Hosur Road Bangalore-560 100, India Mail: [email protected] ∙ Web: www.ind.tuv.com Produkte Products www.tuv.com Prüfbericht - Nr.: Test Report No.: IN22G8KZ 001 Seite 2 von 3 Page 2 of 3 RF Exposure Report Following FCC KDB 447498 D01 General SAR test exclusion guidelines The corresponding SAR exclusion threshold condition, listed below: 1) The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation Distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/ (min. test separation distance, mm)] · [√f (GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g. Extremity SAR, where f(GHz) is the RF channel transmit frequency in GHz Power and distance are rounded to the nearest mW and mm before calculation. The result is rounded to one decimal place for comparison The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm and for transmission frequencies between 100 MHz and 6 GHz. 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(447498 D01 General RF Exposure Guidance v06) 2) At 100 MHz to 6 GHz and for test separation distances > 50 mm, the SAR test exclusion threshold Is determined according to the following [Power allowed at numeric threshold for 50 mm in step 1) + (test separation distance - 50 mm)·( f(MHz)/150)] mW, at 100 MHz to 1500 MHz [Power allowed at numeric threshold for 50 mm in step 1) + (test separation distance - 50 mm)·10] mW at > 1500 MHz and ≤ 6 GHz 3) At frequencies below 100 MHz, the following may be considered for SAR test exclusion, The power threshold at the corresponding test separation distance at 100 MHz in step 2) is multiplied by [1 + log(100/f(MHz))] for test separation distances > 50 mm and < 200 mm The power threshold determined by the equation in a) for 50 mm and 100 MHz is multiplied by ½ for test separation distances ≤ 50 mm SAR measurement procedures are not established below 100 MHz When SAR test exclusion cannot be applied, a KDB inquiry is required to determine SAR evaluation requirements for any test results to be acceptable. Produkte Products www.tuv.com Prüfbericht - Nr.: Test Report No.: IN22G8KZ 001 Seite 3 von 3 Page 3 of 3 SAR Test Exclusion Thresholds Maximum Measured Transmitter Power: Frequency (GHz) Max.Power Including Tune-up Tolarence (dBm) Max.Power Including Tune-up Tolarence (mW) Min.Test Separation distance (mm) SAR Test Exclusion Calculation Values 1-g Extremity SAR Test exclusion Thresholds 2.402 4.72 2.9648 1.19 0.9189 ≤3 2.426 4.36 2.7289 1.19 0.8500 ≤3 2.480 3.77 2.3823 1.19 0.7503 ≤3 Hence, the EUT is exempted from routine SAR evaluation Note: 1. Calculate SAR exclusion threshold from condition 1) formulas. 2. Client declared as tune up tolerance 0dB
Prüfbericht – Produkte Test Report - Products Prüfbericht-Nr.: Test report no.: IN22G8KZ 001 Auftrags-Nr.: Order no.: 146747176 0010 Seite 1 von 47 Page 1 of 47 Kunden-Referenz-Nr.: Client reference no.: 2288216 Auftragsdatum: Order date: 2022-12-19 Auftraggeber: Client: Zywie, Inc 12000 Findley Road, Suite 360, Johns Creek, GA-30097, USA Prüfgegenstand: Test item: ZywieZ3™ Sensor & Adhesive Bezeichnung Identification Z31000016 Serien -Nr.: Serial no.: PRT0036 Auftrags-Inhalt: Order content: Testing and issue of Test Report with Grant Certificate Prüfgrundlage: Test specification: FCC Part 15 Subpart C 15.247,15.205, 15.207 & 15.209 Wareneingangsdatum: Date of sample receipt: 2022-12-20 Prüfmuster-Nr.: Test sample no: A003392716-001 & A003392716-002 Prüfzeitraum: Testing period: 2023-03-27 - 2023-03-27 Ort der Prüfung: Place of testing: Wireless laboratory, Bangalore Prüflaboratorium: Testing laboratory: TÜV Rheinland (India) Pvt. Ltd. 27/B,2nd cross road, Electronic city Phase1, Banglore-560100, India FCC Test Site Registration No: 496599 IC Test Site Registration No: 3466E-1 Prüfergebnis*: Test result*: Pass geprüft von: tested by: genehmigt von: authorized by: Datum: Date: 2023-03-28 Ausstellatum: Issue date: 2023-04-06 Stellung / Position: M.V.Naveen Kumar Engineer Stellung / Position: Madhu K.N Senior Engineer Sonstiges / Other: FCC ID: 2BAK3Z3E Zustand des Prüfgegenstandes bei Anlieferung: Condition of the test item at delivery: Prüfmuster vollständig und unbeschädigt Test item complete and undamaged * Legende: 1 = sehr gut 2 = gut 3 = befriedigend 4 = ausreichend 5 = mangelhaft P(ass) = entspricht o.g. Prüfgrundlage(n) F(ail) = entspricht nicht o.g. Prüfgrundlage(n) N/A = nicht anwendbar N/T = nicht getestet * Legend: 1 = very good 2 = good 3 = satisfactory 4 = sufficient 5 = poor P(ass) = passed a.m. test specification(s) F(ail) = failed a.m. test specification(s) N/A = not applicable N/T = not tested Dieser Prüfbericht bezieht sich nur auf das o.g. Prüfmuster und darf ohne Genehmigung der Prüfstelle nicht auszugsweise vervielfältigt werden. Dieser Bericht berechtigt nicht zur Verwendung eines Prüfzeichens. This test report only relates to the a. m. test sample. Without permission of the test center this test report is not permitted to be duplicated in extracts. This test report does not entitle to carry any test mark. TÜV Rheinland (India) Pvt. Ltd, Plot No.27/B, 2nd Cross, Electronic city, Industrial Area, Phase I, Hosur Road Bangalore-560 100, India Mail: [email protected] ∙ Web: www.ind.tuv.com Produkte Products www.tuv.com Prüfbericht - Nr.: Test Report No.: IN22G8KZ 001 Seite 2 von 47 Page 2 of 47 1 Alle eingesetzten Prüfmittel waren zum angegebenen Prüfzeitraum gemäß eines festgelegten Kalibrierungsprogramms unseres Prüfhauses kalibriert. Sie entsprechen den in den Prüfprogrammen hinterlegten Anforderungen. Die Rückverfolgbarkeit der eingesetzten Prüfmittel ist durch die Einhaltung der Regelungen unseres Managementsystems gegeben. Detaillierte Informationen bezüglich Prüfkonditionen, Prüfequipment und Messunsicherheiten sind im Prüflabor vorhanden und können auf Wunsch bereitgestellt werden. The equipment used during the specified testing period was calibrated according to our test laboratory calibration program. The equipment fulfils the requirements included in the relevant standards. The traceability of the test equipment used is ensured by compliance with the regulations of our management system. Detailed information regarding test conditions, equipment and measurement uncertainty is available in the test laboratory and could be provided on request. 2 Wie vertraglich vereinbart, wurde dieses Dokument nur digital unterzeichnet. Der TÜV Rheinland hat nicht überprüft, welche rechtlichen oder sonstigen diesbezüglichen Anforderungen für dieses Dokument gelten. Diese Überprüfung liegt in der Verantwortung des Benutzers dieses Dokuments. Auf Verlangen des Kunden kann der TÜV Rheinland die Gültigkeit der digitalen Signatur durch ein gesondertes Dokument bestätigen. Diese Anfrage ist an unseren Vertrieb zu richten. Eine Umweltgebühr für einen solchen zusätzlichen Service wird erhoben. As contractually agreed, this document has been signed digitally only. TUV Rheinland has not verified and unable to verify which legal or other pertaining requirements are applicable for this document. Such verification is within the responsibility of the user of this document. Upon request by its client, TUV Rheinland can confirm the validity of the digital signature by a separate document. Such request shall be addressed to our Sales department. An environmental fee for …
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12000 Findley Road, Suite 360 · Johns Creek, Georgia · United States
| # | Rule Parts | Frequency Range | Power Output |
|---|---|---|---|
| 1 | 15C | 2.40 GHz - 2.48 GHz | 3.00 mW |