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OU9TMB1014BTBLOOD PRESSURE MONITOR

Guangdong Transtek Medical Electronics Co.,Ltd
BLOOD PRESSURE MONITOR - FCC ID OU9TMB1014BT - Guangdong Transtek Medical Electronics Co.,Ltd
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Application Details

Equipment Class
DSS - Part 15 Spread Spectrum Transmitter
Date of Grant
Oct 10, 2012
Application Purpose
Original Equipment
Date of Application
Oct 10, 2012
Equipment Note
BLOOD PRESSURE MONITOR
Frequency Range
2402.00000000 - 2480.00000000
Company
Guangdong Transtek Medical Electronics Co.,Ltd
Country
China

Documents & Files

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Users Manual

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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

User Manual Blood Pressure Monitor TMB-1014-BT To use the monitor correctly and safely, please read the manual thoroughly. Thank you very much for selecting TRANSTEK Blood Pressure Monitor TMB-1014-BT. Please well keep this manual in order to reference in future. Zhongshan Transtek Electronics Co., Ltd Jin’an Road, Minzhong, Zhongshan 528441, Guangdong, China Wrist Type Version:1.0  CATALOGUEINTRODUCTION INTRODUCTION1 Safety information LCD display signal Monitor components BEFORE YOU START4 The Choice of power supply Installing and replacing the batteries Setting Date, time and measurement unit MEASUREMENT7 Tie the cuff Strat a measurement THE OPERATION OF RECALLING RECORDS9 Recall the records Delete the records INFORMATION FOR USER11 Tips for operation Maintenances ABOUT BLOOD PRESSURE13 What are systolic pressure and diastolic pressure? What is the standard blood pressure classification? Why does my blood pressure fluctuate throughout the day? Why the blood pressure I get from the hospital is different from home? If the result is the same if measuring on the right wrist? TROUBLESHOOTING15 SPECIFICATIONS16 CONTACT INFORMATION17 The below signs might be in the user manual, labeling or other component. They are the requirement of standard and using. Safety information This device is intended for adult use only. This device is intended for no-invasive measuring and monitoring of arterial blood pressure. It is not intended for use on extremities other than the wrist or for functions other than obtaining a blood pressure measurement. Do not confuse self-monitoring with self-diagnosis. This unit allows you to monitor your blood pressure.Do not begin or end medical treatment based solely physician for treatment advice. If you are taking medication,consult your physician to determine the most appropriate time to measure your blood pressure. Never change a prescribed medication without consulting your physician. This unit is not suitable for continuous monitoring during medical emergencies or operations. If the cuff pressure exceeds 40 kPa (300 mmHg),the unit will automatically deflate. Should the cuff not deflate when pressures exceeds 40 kPa (300 mmHg),detach the cuff from the wrist and press the START/STOP button to stop inflation. To avoid measurement errors, carefully read this manual before using the product. The equipment is not AP/APG equipment and not suitable for use in the presence of a flammable anesthetic mixture with air of with oxygen or nitrous oxide. The operator shall not touch the battery and the patient simultaneously. The user must check that the equipment functions safely and see that it is in proper working condition before being used. The manufacturer does not require such preventive inspections by other persons. The Max. temperature of apply part can be achieved is 42.5 under the environmental temperature of 40. Manufacture will make available on request circuit diagrams, component part list, etc. CAUTION Caution:Consult accompanying documents CE Mark: conforms to essential requirements of the Medical Device Directive 93/42/EEC. Manufacturer Specifies serial number Type B applied part Direct current D I S P O S A L : D o n o t d i s p o s e t h i s product as unsorted municipal waste. Collection of such waste separately for special treatment is necessary. Authorized Representative in the European Community EC REP Thank you for selecting TRANSTEK wrist blood pressure Monitor (TMB-1014-BT). The monitor features blood pressure measurement, pulse rate measurement and auto-save the result. The design provides you with many years of reliable service. Reading taken by the TMB-1014-BT are equivalent to those obtained by a trained observer using the cuff and stethoscope auscultation method. This manual contains important safety and care information, and provides step by step instruction for using the product. Read the manual thoroughly before using the product. Features: Systolic blood pressure Diastolic blood pressure Pulse rate Historic record of up to 60 measurements  LCD DISPLAY SYSTOLIC DIASTOLIC MEM/UP BUTTON SET/DOWN BUTTON START/OFF BUTTON CUFF (Type B applied part) PULSE RATE GRADE TIME BATTERY COMPARTMENT INTRODUCTIONINTRODUCTION Monitor components LCD display signal 6 < 0 % 2 / ' (6 & 5 ,37,2 1 (; 3/$ 1 $ 7,2 1 Systolic blood pressure High pressure result Diastolic blood pressure Low pressure result PulsePulse/minute mmHgMeasurement unit the blood pressure TimeCurrently time Low battery Batteries are low and need to be replaced Error User Recalling Blood pressure monitor has detected error The current selected user The erecords will be showed BluetoothBluetooth is in an open position Grade The grade of the blood pressure For instructions,refer to Page 13 ArrhythmiaArrhythmia is detected  BEFORE YOU STARTBEFORE YOU START  Slide off the battery cover.  Install the batteries by matching the correct polarity, as shown below . Always use the correct battery type (2 alkaline LR03AAA-size).  Replace the cover. The installment and replacement of battery Setting Date, time and measurement unit It is important to set the clock before using your blood pressure monitor, so that a time stamp can be assigned to each record that is stored in the memory. In sure the “lock” key is glided to the unlock mode.(year :2010—2050; time:24 H)) Remove batteries if the device is not likely to be used for some time. The old battery is harmful to the environment, so please disposal with other dail…

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Cover Letter(s)

Zhongshan Transtek Electronics Co., Ltd. Jin’an Road, Minzhong, Zhongshan 528441, Guangdong, China Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: OU9TMB1014BT. Pursuant to Sections 0.457 and 0.459 of the Commission’s Rules, we hereby request confidential treatment of information accompanying this application as outlined below: Exhibit Type File Name Block Diagram Block Diagram.pdf Schematics Schematics.pdf Operational Description Operational Description.pdf Part List Part List.pdf The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, ----------------------------------------------- Terry Chen / Compliance Engineer Company Name: Zhongshan Transtek Electronics Co., Ltd. Tel: +86-760-8828 2982-8 Fax: +86-760-85339231 Email: [email protected]

Cover Letter(s)

SGS-CSTC Standards Technical Services Co., Ltd. Test Lab Attestation Letter This attestation is to confirm that the below listed device was tested at our Test Facilities located at: Test Lab Name: SGS-CSTC Standards Technical Services Co., Ltd. Test Lab Address: 198 Kezhu Road, Scientech Park, Guangzhou Economic & Technology Development District, Guangzhou, China 510663 Test Lab Registration Number: 282399 Date of Test: 2012-09-06 and 2012-09-21 to 2012-09-24 Test Report Number: GZEM120800320301 GZEM120800320302 Applicant Name: Zhongshan Transtek Electronics Co., Ltd. FCC ID: OU9TMB1014BT Name of Engineer(s) Performing Test: Rain Yuan Daniel He Company Name of Engineer(s) Performing Test: SGS-CSTC Standards Technical Services Co., Ltd. TEST LABORATORY: Signature of Authorized Representative of the Test Laboratory: Full Contact Name: Strong Yao Position/Title: Lab Manager SGS-CSTC Standards Technical Services Co., Ltd. Products Photos SGS-CSTC Standards Technical Services Co., Ltd.

External Photos

External Photos

ID Label/Location Info

TMB-1014-BT Model ECREP Jin'an Road,Minzhong,Zhongshan,528441,Guangdong,China Rating:3V 35.00 SN:xxxxxxxxxxxxxx FCC ID: OU9TMB1014BT TMB-1014-BT Model EC REP Jin'an Road,Minzhong,Zhongshan,528441,Guangdong,China Rating : 3V FCC ID OU9TMB1014BT

Internal Photos

Internal Photos

RF Exposure Info

SGS-CSTC Standards Technical Services Co., Ltd. Application No..: GZEM1208003203ME Page: 1 of 2 FCC ID: OU9TMB1014BT This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. 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 instructions, 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. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. 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. RF Exposure Compliance Requirement 1. Standard requirement Systems operating under the provisions of this section shall be operated in a manner that ensures that the public is not exposed to radio frequency energy level in excess limit for maximum permissible exposure. In accordance with 47 CFR FCC Part 2 Subpart J, section 2.1091 this device has been defined as a mobile device whereby a distance of 0.2m normally can be maintained between the user and the device. (a) Limits for Occupational / Controlled Exposure Frequency Range (MHz) Electric Field Strength (E) (V/m) Magnetic Field Strength (H) (A/m) Power Density (S)(mW/cm 2 ) Averaging Times ׀E׀ 2 , ׀H׀ 2 or S (minutes) 0.3-3.0 614 1.63 (100)* 6 3.0-30 1842/f 4.89/f (900/f)* 6 30-300 61.4 0.163 1.0 6 300-1500 -- -- F/300 6 1500-100000 -- -- 5 6 (b) Limits for General Population / Uncontrolled Exposure Frequency Range (MHz) Electric Field Strength (E) (V/m) Magnetic Field Strength (H) (A/m) Power Density (S)(mW/cm 2 ) Averaging Times ׀E׀ 2 , ׀H׀ 2 or S (minutes) 0.3-1.34 614 1.63 (100)* 30 1.34-30 824/f 2.19/f (180/f)* 30 30-300 27.5 0.073 0.2 30 300-1500 -- -- F/1500 30 1500-100000 -- -- 1.0 30 Note: f=frequency in MHz; *Plane-wave equivalent power density SGS-CSTC Standards Technical Services Co., Ltd. Application No..: GZEM1208003203ME Page: 2 of 2 FCC ID: OU9TMB1014BT This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. 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 instructions, 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. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. 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. 2. MPE Calculation Method E (V/m)=(30*P*G) 0.5 /d Power Density: Pd(W/m 2 )=E 2 /377 E=Electric Field (V/m) P=Peak RF output Power (W) G=EUT Antenna numeric gain (numeric) d= Separation distance between radiator and human body (m) The formula can be changed to Pd= (30*P*G)/(377*d 2 ) From the peak EUT RF output power, the minimum mobile separation distance, d=0.2m, as well as the gain of the used antenna, the RF power density can be obtained. 3. Calculated Result and Limit (1)GFSK mode: Frequency (MHz) Antenna Gain (Numeric) Peak Output Power (dBm) Peak Output Power (mW) Power Density (S) (mW/cm 2 ) Limit of Power Density (S) (mW/cm 2 ) Test Result 2402 1.259 -2.72 0.535 0.00013 1 Complies 2442 1.259 -2.33 0.585 0.00015 1 Complies 2480 1.259 -1.66 0.682 0.00017 1 Complies

Test Report

SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road, Scientech Park, Guangzhou Economic & Technological Development District, Guangzhou, China 510663 Telephone: +86 (0) 20 82155555 Fax: +86 (0) 20 82075059 Email: [email protected] Report No.: GZEM120800320302 Page: 1 of 48 FCC ID: OU9TMB1014BT Authorized Signature: Strong Yao Manager The manufacturer should ensure that all products in series production are in conformity with the product sample detailed in this report. If the product in this report is used in any configuration other than that detailed in the report, the manufacturer must ensure the new system complies with all relevant standards. The report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government. All test results in this report can be traceable to National or International Standards. This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. 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 instructions, 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. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. 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 1 Cover Page TEST REPORT Application No.: GZEM1208003203ME Applicant: Zhongshan Transtek Electronics Co., Ltd. FCC ID: OU9TMB1014BT Product Name: Blood Pressure Monitor Product Description: Blood Pressure Monitor Model No.: TMB-1014-BT Standards: 47 CFR PART 15 Subpart C: 2011 section 15.247 Date of Receipt: 2012-09-21 Date of Test: 2012-09-21 to 2012-09-24 Date of Issue: 2012-09-27 Test Result : Pass* * In the configuration tested, the EUT detailed in this report complied with the standards specified above. Please refer to section 3 of this report for further detail. SGS-CSTC Standards Technical Services Co., Ltd. Report No.: GZEM120800320302 Page: 2 of 48 FCC ID: OU9TMB1014BT This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. 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 instructions, 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. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. 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. 2 Version Revision Record Version Chapter Date Modifier Remark 00 2012-09-27 Original Authorized for issue by: Tested By 2012-09-21 to 2012-09-24 (Daniel He) /Signature Date Prepared By 2012-09-26 (Daniel He) /Signature Date Checked By 2012-09-27 (Strong Yao) /Reviewer Date SGS-CSTC Standards Technical Services Co., Ltd. Report No.: GZEM120800320302 Page: 3 of 48 FCC ID: OU9TMB1014BT This document is issued by the Company subject to its General Conditions of Service printed overleaf, available on request or accessible at www.sgs.com/terms_and_conditions.htm and, for electronic format documents, subject to Terms and Conditions for Electronic Documents at www.sgs.com/terms_e-document.htm. 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 instructions, 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. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and offenders may be prosecuted to the fullest extent of the law. 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. 3 Test Summary TEST TEST REQUIREMENT TEST METHOD RESULT Antenna Requirement FCC PART 15 C section 15.247 (c) and Section 15.203 FCC PART 15 C section 15.247 (c) and Section 15.203 PASS 6 dB Bandwidth FCC PART 15 C section 15.247 (a)(2) ANSI C63.10: Clause 6.9.1 PASS Maximum Peak Output Power FCC PART 15 C section …

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Test Setup Photos

Test Setup Photos Radiated Emissions, 9 kHz to 30 MHz Radiated Emissions, 30 MHz to 400 MHz Test Setup

Contact Information

Applicant

Jerry Fan(RA Manager)
[email protected]+86-760-85166220Fax: +86-760-86742877

Test Firm

SGS-CSTC Standards Technical Services Co., LtdJerry Chan
[email protected]860-208215-5331Fax: 860-208207-5059

Technical Specifications

#Rule PartsFrequency RangePower Output
115C2.40 GHz - 2.48 GHz700.00 µW
Confidentiality
Long Term
Grant Notes
Power listed is conducted. This device and its antenna(s) must not be co-located or operating in conjunction with any other antenna or transmitter. End-users must be provided with specific operating instructions for satisfying RF exposure compliance.

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