SMQFTS3BEDANFetal Telemetry System

 I About this Manual P/N: 01.54.455327 MPN: 01.54.455327017 Release Date: Jan. 2015 © Copyright EDAN INSTRUMENTS, INC. 2008 - 2015. All rights reserved. Statement This manual will help you understand the operation and maintenance of the product better. It is reminded that the product shall be used strictly complying with this manual. User’s operation failing to comply with this manual may result in malfunction or accident for which EDAN INSTRUMENTS, INC. (hereinafter called EDAN) can not be held liable. EDAN owns the copyrights of this manual. Without prior written consent of EDAN, any materials contained in this manual shall not be photocopied, reproduced or translated into other languages. Materials protected by the copyright law, including but not limited to confidential information such as technical information and patent information are contained in this manual, the user shall not disclose such information to any irrelevant third party. The user shall understand that nothing in this manual grants him, expressly or implicitly, any right or license to use any of the intellectual properties of EDAN. EDAN holds the rights to modify, update, and ultimately explain this manual. Product Information Product Name: Fetal & Maternal Monitor Model: F6, F6 Express, F9, F9 Express Responsibility of the Manufacturer EDAN only considers itself responsible for any effect on safety, reliability and performance of the equipment if: Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by EDAN, and The electrical installation of the relevant room complies with national standards, and The instrument is used in accordance with the instructions for use. Upon request, EDAN may provide, with compensation, necessary circuit diagrams, and other II information to help qualified technician to maintain and repair some parts, which EDAN may define as user serviceable. Terms Used in this Manual This guide is designed to give key concepts on safety precautions. WARNING A WARNING label advises against certain actions or situations that could result in personal injury or death. CAUTION A CAUTION label advises against actions or situations that could damage equipment, produce inaccurate data, or invalidate a procedure. NOTE A NOTE provides useful information regarding a function or a procedure. III Table of Contents Chapter 1 Safety Guide ················································································································ 1 1.1 Intended Use....................................................................................................................... 1 1.2 Features .............................................................................................................................. 2 1.3 Instruction for Safe Operation ............................................................................................ 2 1.4 Ultrasound Safety Guide .................................................................................................... 3 1.5 Safety Precautions .............................................................................................................. 4 1.6 Definitions and Symbols .................................................................................................. 11 Chapter 2 Installation Guide ······································································································ 15 2.1 Opening and Checking Package ....................................................................................... 15 2.2 Installing Battery .............................................................................................................. 15 2.3 Installing Monitor ............................................................................................................ 16 2.4 Connecting Power Cable .................................................................................................. 17 Chapter 3 Monitor and Accessories ··························································································· 18 3.1 Overview .......................................................................................................................... 18 3.1.1 Keys and Control Knob .......................................................................................... 19 3.1.2 Indicators ................................................................................................................ 21 3.2 Accessories ....................................................................................................................... 22 3.2.1 Ultrasound (US) Transducers ................................................................................. 22 3.2.2 TOCO Transducers ................................................................................................ 22 3.2.3 Belt ......................................................................................................................... 23 3.2.4 Remote Event Marker ............................................................................................ 23 3.2.5 DECG Cable........................................................................................................... 23 3.2.6 Fetal Spiral Electrode ............................................................................................. 24 3.2.7 IUP Cable ............................................................................................................... 24 3.2.8 IUP Catheter ........................................................................................................... 25 3.2.9 ECG Cable ............................................................................................................. 25 3.2.10 SpO 2 Sensor ......................................................................................................... 25 3.2.11 NIBP Cuff ...............................…

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EDAN INSTRUMENTS, INC. 022311 – 6 Authority to Act as Agent Date: 2014-12-15 American Certification Body, Inc. 6731 Whittier Avenue Suite C110 McLean, VA 22101 To Whom It May Concern: Shenzhen Huatongwei International Inspection Co., Ltd / Hans Hu is authorized to act on our behalf, until otherwise notified, for applications to American Certification Body, Inc. (ACB). 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 Expiration Date: _____2015-12-01_____ By: Huanhuan Xia (Signature 1 ) (Print name) Title: Engineers On behalf of: EDAN INSTRUMENTS,INC. (Company Name) Telephone: 86- 0755-26682547 1 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead.

EDAN INSTRUMENTS, INC. 022311 – 6 Request for Confidentiality Date: 2014-12-15 Subject: Confidentiality Request for: FCC ID: SMQFTS3BEDAN Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, 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 External Photos Short Term Permanent* 2 Internal Photos Short Term Permanent Operation Description/Theory of Operation Short Term Permanent Parts List & Placement/BOM Short Term Permanent Tune-Up Procedure Short Term Permanent Schematics Short Term Test Setup Photos Short Term Permanent* User’s Manual *Note: ______(Insert Explanation as Necessary)______ Edan Instruments, Inc. has spent substantial effort in developing this product and it is one of the first of its kind in 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 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 ___(specify number of days not to exceed 180 ) 3 ___ days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Applicant is also aware that they are responsible to notify ACB in the event information regarding the product or the product is made available to the public. ACB will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. NOTE for Industry Canada Applications: The applicant understands that until such time that IC distinguishes between Short Term and Permanent Confidentiality, either type of marked exhibit above will simply be marked Confidential when submitted to IC. Sincerely, Huanhuan Xia By: (Signature4) (Print name) 2 - The asterisked items (*) require further justification before permanent confidentiality will be allowed. These also currently require review by the FCC under their Permit-But-Ask policy before the grant is issued and can delay completion of an application. Further justification should be added to the note above. One such example for a potted device would be: “The EUT is FULLY potted using a non-removable epoxy based material. Removal of potting material causes irreparable damage to internal circuitry. See photographs exhibits that outline the device before and after potting.” 3 - Please refer to http://acbcert.com/documents/misc-docs/Memo-Short-Term-Vs-Standard-Confidentiality.pdf for complete details. 4 - Must be signed by applicant contact given for applicant on the FCC site, or by the authorized agent if an appropriate authorized agent letter has been provided. Letters should be placed on appropriate letterhead.

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Report N Report R FCC ID. .. Applican Address .. Manufactu Address.. Test item Trade Ma Model/Typ Listed Mo Standard Date of re Date of te Date of is Result .... Compiled ( position + Supervise ( position+ Approved ( position + Testing L Address .. Shenzhen This publi Huatongw Shenzhen for damag context. o.: TRE140 5 Reference No .................... t’s name ..... .................... urer.............. .................... m description ark ................ pe reference odel(s) .......... d ................... eceipt of test esting ........... sue... .......... .............. ...... by +printed nam ed by +printed nam by +printed nam Laboratory N .................... n Huatongw cation may b wei Internatio n Huatongwe ges resulting 5010303 RF E o. ................. .................... .................... .................... .................... .................... n ................. .................... e ................... .................... .................... sample ....... .................... .................... .................. me+signature me+signature me+signature Name .......... .................... wei Internatio be reproduce onal Inspectio ei Internation from the rea EXPO ... : TRE1 ... : SMQ ... : Edan .... : 3/F - She k .....: Edan ......: 3/F - She k ... : Fetal .... : .... : FTS- .... : / ... : FCC .... : Mar 1 .... : Mar 1 .... : Oct 2 ......: PASS e) .. : File a e) .. : Proje e) .. : RF M ... : She n .... : Keji N onal Inspec ed in whole o on Co., Ltd is nal Inspection ader's interpr OSUR 1403012406 QFTS3BEDAN n Instrument B, Nanshan kou, Nanshan n Instruments B, Nanshan kou, Nanshan l Telemetry 3 Per 47 CF R 19, 2014 19 ~ Oct 22, 22, 2014 S administrator ect Engineer Manager Han nzhen Huato Nan No.12 R ction Co., Ltd or in part for s acknowledg n Co., Ltd tak retation of th RE RE N ts, Inc. Medical Eq u n Shenzhen, s, Inc. Medical Eq u n Shenzhen, System R 2.1093(d) 2014 rs May Hu Lion Cai ns Hu ongwei Inter Road, Hi-tech d. All rights non-commer ged as copy kes no respo e reproduce EPOR R/C......... uipments Pa 518067 P. R uipments Pa 518067 P. R rnational Ins h Park, Shenz reserved. rcial purpose right owner a onsibility for a d material du Page 1 RT ....: 49068 rk, Nanhai R R. China rk, Nanhai R R. China spection Co zhen, China es as long as and source o and will not a ue to its plac of 8 Rd 1019#, Rd 1019#, o., Ltd s the Shenzh of the materia assume liabil cement and hen al. lity Report No.: TRE1403012406 Page 2 of 8 Contents 1. SUMMARY ............................................................................... 3 1.1. Client Information 3 1.2. Product Description 3 1.3. EUT operation mode 4 1.4. EUT configuration 4 1.5. Modifications 4 2. TEST ENVIRONMENT .................................................................. 5 2.1. Address of the test laboratory 5 2.2. Test Facility 5 2.3. Environmental conditions 6 2.4. Statement of the measurement uncertainty 6 Report No.: TRE1403012406 Page 3 of 8 1. SUMMARY 1.1. Client Information Applicant: Edan Instruments, Inc. Address: 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen,518067 P.R. China Manufacturer: Edan Instruments, Inc. Address: 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen,518067 P.R. China 1.2. Product Description Name of EUT Fetal Telemetry System Trade Mark: Model No.: FTS-3 Listed Model(s): / Power supply: DC 14.8V From Internal Battery Adapter information: / Modulation: FSK Operation frequency: 608MHz-614MHz Channel number: 32 Channel separation: 180KHz Antenna type: Internal Antenna Antenna gain: 2 dBi Report No.: TRE1403012406 Page 4 of 8 Operation Frequency List: Channel Frequency (MHz) 01 608.20 02 608.38 03 608.56 ... ... 16 610.90 ... ... 30 613.42 31 613.60 32 613.78 Note:In section 15.31(m), regards to the operating frequency range over 10 MHz, the Lowest frequency, the middle frequency, and the highest frequency of channel were selected to perform the test, please see the above gray bottom. 1.3. EUT operation mode The EUT has been tested under test mode condition. The Applicant provides software to control the EUT for staying in continous transmitting and receiving mode for testing. Test mode:GFSK Modulation 1.4. EUT configuration The following peripheral devices and interface cables were connected during the measurement: ● - supplied by the manufacturer ○ - supplied by the lab ○ Power Cable Length (m) : / Shield : / Detachable : / ○ Multimeter Manufacturer : / Model No. : / 1.5. Modifications No modifications were implemented to meet testing criteria. Report No.: TRE1403012406 Page 5 of 8 2. TEST ENVIRONMENT 2.1. Address of the test laboratory Shenzhen Huatongwei International Inspection Co., Ltd. Keji Nan No.12 Road, Hi-tech Park, Shenzhen, China Phone: 86-755-26748019 Fax: 86-755-26748089 2.2. Test Facility The test facility is recognized, certified, or accredited by the following organizations: CNAS-Lab Code: L1225 Shenzhen Huatongwei International Inspection Co., Ltd. has been assessed and proved to be in compliance with CNAS-CL01 Accreditation Criteria for Testing and Calibration Laboratories (identical to ISO/IEC 17025: 2005 General Requirements) for the Competence of Testing and Calibration Laboratories, Date of Registration: Mar. 01, 2012. Valid time is until February 28, 2015. A2LA-Lab Cert. No. 2243.01 Shenzhen Huatongwei International Inspection Co., Ltd. EMC Laboratory has been accredited by A2LA for technical competence in the field of electrical testing, and proved to be in compliance with ISO/IEC 17025: 2005 General Requirements for the Competence of Testing and Calibration Laboratories and any additional program requirements in the identified field of testing. Valid time is until Sept 30, 2015. FCC-Registration No.: 662850 Shenzhen Huatongwei International Inspection Co., Ltd. EMC Laboratory has been registered and fully described in a report filed with the FCC (Federal Communications Commiss…

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Shenzhen This publi Huatongw Shenzhen for damag context. report merely ermitted to c Reference No .................... t’s name ..... .................... urer.............. .................... m description ark ................ pe reference odel(s) .......... d ................... eceipt of test esting............ sue............ .............. ...... by +printed nam ed by +printed nam by +printed nam Laboratory N .................... n Huatongw cation may b wei Internatio n Huatongwe ges resulting y correspond opy extracts o. ................. .................... .................... .................... .................... .................... n ................. .................... e ................... .................... .................... sample...... .................. ..................... .................. me+signature me+signature me+signature Name .......... .................... wei Internatio be reproduce onal Inspectio ei Internation from the rea ds to the test of these te s TES ... : ... : TRE1 SMQ ... : Edan .... : 3/F - She k .....: Edan ......: 3/F - She k ... : Feta .... : .... : FTS - .... : / ... : FCC (WM .....: Mar ......: Mar ......: Oct 2 ......: PASS e) .. : File a e) .. : Proje e) .. : RF M ... : She n .... : Bldg 3 China onal Inspec ed in whole o on Co., Ltd is nal Inspection ader's interpr sample. st result witho ST RE 1403012403 QFTS3BEDA n Instrumen B, Nanshan kou, Nanshan n Instruments B, Nanshan kou, Nanshan l Telemetry -3 CFR Title 4 TS) 19, 2014 19 ~ Oct 22, 22, 2014 S administrator ect Engineer Manager Han nzhen Huato 3, Hongfa Hi a ction Co., Ltd or in part for s acknowledg n Co., Ltd tak retation of th out the writte EPOR 3 AN ts, Inc. n Medical Equ n Shenzhen, s, Inc. n Medical Equ n Shenzhen, System 47 Part 95H W 2014 rs Any Yang Lion Cai ns Hu ongwei Inter i-tech Industr d. All rights non-commer ged as copy kes no respo e reproduce en permission RT R/C......... uipments Pa ,518067 P.R uipments Pa ,518067 P.R Wireless Me rnational Ins rial Park, Ge reserved. rcial purpose right owner a onsibility for a d material du n of the test l ....:49068 ark, Nanhai R R. China ark, Nanhai R R. China edical Telem spection Co enyu Road, S es as long as and source o and will not a ue to its plac laboratory. Rd 1019#, Rd 1019#, metry Servic o., Ltd Shenzhen, s the Shenzh of the materia assume liabil cement and ce hen al. lity Report No : TRE1403012403 Page 2 of 27 Contents 1. TEST STANDARDS AND TEST DESCRIPTION 3 1.1. Test Standards 3 1.2. Test Description 3 2. SUMMARY 4 2.1. Client Information 4 2.2. Product Description 4 2.3. EUT operation mode 5 2.4. EUT configuration 5 2.5. Modifications 5 3. TEST ENVIRONMENT 6 3.1. Address of the test laboratory 6 3.2. Test Facility 6 3.3. Environmental conditions 7 3.4. Statement of the measurement uncertainty 7 3.5. Equipments Used during the Test 8 4. TEST CONDITIONS AND RESULTS 9 4.1. Conducted Emissions 9 4.2. Occupied bandwidth 12 4.3. Frequency stability 14 4.4. Spurious Emission (radiated) 16 5. TEST SETUP PHOTOS OF THE EUT 2 1 6. EXTERNAL AND INTERNAL PHOTOS OF THE EUT 2 2 Report No : TRE1403012403 Page 3 of 27 1. TEST STANDARDS AND TEST DESCRIPTION 1.1. Test Standards The tests were performed according to following standards: FCC Rules 47 CFR Part 95: Title 47 of the Code of Federal Regulations; Chapter I Subpart H—Wireless Medical Telemetry Service (WMTS); Part 95 - Personal radio services FCC Rules 47 CFR Part 2: -FREQUENCY ALLOCATIONS AND RADIO TREATY MATTERS; GENERAL RULES AND REGULATIONS 1.2. Test Description Test Item Section in CFR 47 Result Conducted Emissions CFR Part 15.107(a) Pass Frequency stability FCC 47 CFR § 2.1055 § 95.1115(e) Pass Occupied bandwidth FCC 47 CFR § 2.1049 (1) Pass Radiated field strength and Field strength of spurious radiation FCC 47 CFR § 2.1053/2.1046 § 95.1115(a)(b) Pass Remark: The measurement uncertainty is not included in the test result. N/A:Mean’s not application. Report No : TRE1403012403 Page 4 of 27 2. SUMMARY 2.1. Client Information Applicant: Edan Instruments, Inc. Address: 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen,518067 P.R. China Manufacturer: Edan Instruments, Inc. Address: 3/F - B, Nanshan Medical Equipments Park, Nanhai Rd 1019#, Shekou, Nanshan Shenzhen,518067 P.R. China 2.2. Product Description Name of EUT FTS-Fetal Telemetry System Trade Mark: Model No.: FTS-3 Listed Model(s): / Power supply: DC 14.8V From Internal Battery Adapter information: / Modulation: FSK Operation frequency: 608MHz-614MHz Channel number: 32 Channel separation: 180KHz Antenna type: Internal Antenna Antenna gain: 2.0 dBi Report No : TRE1403012403 Page 5 of 27 Operation Frequency List: Channel Frequency (MHz) 01 608.20 02 608.38 03 608.56 ... ... 16 610.90 ... ... 30 613.42 31 613.60 32 613.78 Note: In section 15.31(m), regards to the operating frequency range over 10 MHz, the Lowest frequency, the middle frequency, and the highest frequency of channel were selected to perform the test, please see the above gray bottom. 2.3. EUT operation mode The worst-case channel is determined as the channel with the highest output power. During emission tests the antenna orientations as X, Y, and Z were investigated to determine the worst-case. The outcome showed that X-orientation for Horizontal and Y-orientation for Vertical as the worst-case. 2.4. EUT configuration The following peripheral devices and interface cables were connected during the measurement: ● - supplied by the manufacturer ○ - supplied by the lab ○ Power Cable Length (m) : / Shield : / Detachable : / ○ Multimeter Manufacturer : / Model No. : / 2.5. Modifications No modifications were implemented to meet testing criteria. Report…

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Report 5. Tes No : TRE1 4 st Setup 403012403 p Photo os of the Radiated Radiate e EUT d Emission (3 ed Emission ( 30MHz-1GH (above 1GHz z) z) Page 21 of 27