2ABOQ-SF1SLWireless Fetal Monitoring Solution

SF1-SL Contents 1. Introduction ........................................................................ 4 1.1 Indications of Use .................................................................................. 4 1.2 Contraindications .................................................................................. 4 1.3 Unpacking / Preliminary Checks .......................................................... 5 2. Safety ................................................................................. 6 2.1 WARNINGS ............................................................................................. 7 3. Product Information ........................................................... 9 3.1 System Overview ................................................................................... 9 3.2 The Receiver Unit................................................................................... 10 3.2.1 Operation................................................................................................................10 3.2.2 Front Panel Indicators ............................................................................................ 11 3.2.3 Rear Panel controls and Indicators ........................................................................ 13 3.3 The Transducers .................................................................................... 14 3.4 Product Labelling ................................................................................... 16 4. Setup ................................................................................... 17 4.1 Receiver Connection ............................................................................. 17 4.2 Testing the Basic Functions ................................................................. 18 5. Operation ........................................................................... 20 5.1 Getting Started ....................................................................................... 20 5.2 Application of the Transducers ............................................................ 20 5.3 Ambulatory Monitoring ......................................................................... 22 5.4 Water Birth Monitoring .......................................................................... 22 5.5 Ending Monitoring / Switching Off ....................................................... 23 6. Care and Cleaning .............................................................. 24 6.1 General Care........................................................................................... 24 6.2 Cleaning and Disinfecting ..................................................................... 25 6.2.1 Transducers ........................................................................................................... 25 6.2.2 Receiver Unit .......................................................................................................... 27 7. Maintenance ....................................................................... 28 7.1 Mechanical Inspection ............................................................................. 28 7.2 Corrective Maintenance ............................................................................ 28 7.3 Charging Transducer Batteries ................................................................ 28 7.4 Transducer Battery Replacement............................................................. 28 7.5 Servicing ..................................................................................................... 28 3 Table of Contents 8. Trouble Shooting ................................................................ 29 8.1 Manually Switching off the Transducers ............................................. 31 8.2 Re-enabling Transducers ...................................................................... 32 8.3 Changing the RF-channel ..................................................................... 33 9. Specifi cations .................................................................... 34 9.1 Equipment Classifi cation ..................................................................... 34 9.2 Receiver Unit (SF1-EUR / SF1-SL) ........................................................ 34 9.3 US-Transducer (SF1-US) ....................................................................... 35 9.4 TOCO-Transducer (SF1-TOCO) ........................................................... 35 9.5 Environmental ........................................................................................ 35 9.6 Directives and Standards Compliance* ............................................... 36 9.7 Recommended Consumables & Accessories* .................................. 36 10. Electromagnetic Compatibility ........................................ 37 11. Ultrasound Safety Considerations ................................... 38 12. End of Life Disposal .......................................................... 42 13. Warranty & Service .......................................................... 43 Appendix 1 - WMTS Channel Allocation ................................. 44 Appendix 2 - ISM Channel Allocation ..................................... 46 4 Introduction 1. Introduction 1.1 Indications of Use The Sonicaid™ Freedom (‘Freedom’) is a wireless fetal monitoring system for the monitoring of fetal heart movement and maternal contractions during intrapartum and antepartum periods of pregnancy. It is an optional accessory for use with Huntleigh Healthcare Limited’s Sonicaid FM820 and FM830 Encore Fetal Monitors (‘FM800E Monitors’) as an alternative to their wired transducers. When connected to an FM800E Monitor, the system monitors: • Uterine activity by using an external, pressure-sensitive TOCO transducer, and • Fetal heart rate (FHR) by pulsed Doppler ultrasound using an external Ultrasound transducer. Freedom is suitable for use in clinical and hospital facilities for use on pre…

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1 Briggs, Mark From:Mucha, Bartlomiej Sent: Thursday, July 24, 2014 8:33 AM To: Briggs, Mark; Danisi, Joseph Subject: RE: Huntleigh Diagnostics, FCC ID: 2ABOQ-SF1TOCO, Assessment NO.: AN14T0320, 321 and 322 Attachments: FCC Appendix 8_778348-J Freedom US Label Set.pdf; FCC Appendix 1 _FCC_Confidentiality Letter 23-07-14 .pdf; Sonicaid Freedom SF1-SL (Receiver Tune-Up Procedure).pdf; Sonicaid Freedom SF1-US (US Transducer Tune-Up Procedure).pdf; RF Exposure Exemption for 2ABOQ-SF1SL.pdf; RF Exposure Exemption for 2ABOQ- SF1US.pdf Mark, See responses below and attachments: Bartlomiej Mucha Consumer Technology Division ************************* UL LLC 333 Pfingsten Rd. Northbrook, IL 60062 From: Briggs, Mark Sent: 7/ 22/ 2014 18:23 To: Mucha, Bartlomiej; Danisi, Joseph Subject: RE: Huntleigh Diagnostics, FCC ID: 2ABOQ‐SF1TOCO, 2ABOQ ‐SF1US and 2ABOQ‐SF1SL Assessment NO.: AN14T0320, 321 and 322 Dear Bart For this series of applications I have the following questions: For the TOCO device (FCC I: 2ABOQ ‐ SF1TOCO)  Please explain how the 10kHz transmitter that the Ultrasound portion will be approved? BM20140724: As described under 15.201(a) Intentional radiators operating below 490 kHz in which all emissions are at least 40 dB below the limits in §15.209 shall be verified pursuant to the procedures in Subpart J of part 2 of this chapter prior to marketing. The emissions from the 10kHz transmitter were all more than 40dB below the limit and so verification is the appropriate approval procedure for this transmitter. For the Ultrasound device (FCC ID: 2ABOQ ‐SF1US)  For the Part 95 power rating on the grant we will need to list the erp. Please explain how the erp is calculated: BM20140724: Field strength of fundamental = 77.89dBuV/m QP at 3m From KDB 412172 D01 v01 section 1.3.1: eirp = p t x gt = (E x d) 2 /30 (1) where: 2 pt = transmitter output power in watts, g t = numeric gain of the transmitting antenna (unitless), E = electric field strength in V/m, d = measurement distance in meters (m). erp = eirp/1.64 = (E x d) 2 /(30 x 1.64) So the erp = (0.0078 V/m x 3) 2 / (30 x 1.64) = 0.00001 Watts  Please confirm that the Ultrasound portion will be approved under Part 18? BM20140724: Confirmed  I do not see the revised label showing: Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. BM20140724: The device is too small to accommodate the statement and also the statement is not truly applicable to this device (the operating frequency is determined by the operating frequency of the receiver unit, FCC ID: 2ABOQ-SF1SL, which is labelled appropriately - see below. The statement is included in the manual. For the receiver unit (FCC ID: 2ABOQ‐SF1SL)  For the Part 95 power rating on the grant we will need to list the erp. Please explain how the erp is calculated: BM20140724: Field strength of fundamental = 82.4dBuV/m QP at 3m From KDB 412172 D01 v01 section 1.3.1: eirp = p t x gt = (E x d) 2 /30 (1) where: p t = transmitter output power in watts, g t = numeric gain of the transmitting antenna (unitless), E = electric field strength in V/m, d = measurement distance in meters (m). erp = eirp/1.64 = (E x d) 2 /(30 x 1.64) So the erp = (0.0132 V/m x 3) 2 / (30 x 1.64) = 0.00003 Watts  I do not see the revised label showing: Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. BM20140724: See revised label exhibit.

HUNTLEIGI-I May 1, 2014 UL CCS Certification Division 47173 Benicia Street Fremont, CA 94538, USA To whom it may concern: I, the undersigned, hereby authorize UL CCS, to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL CCS on our behalf shall have the same effect as acts of our own. I, 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). authorizing UL CCS as our agent, we still recognize that we are responsible to: a) comply with the relevant provisions of the certification program; b) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment surveillance, reassessment) and resolution of complaints c) make claims regarding certification only in respect of the scope for which certification has been granted; d) do not use our product certification in such a manner as to bring the certification Division into disrepute and not make any statement regarding our product certification which the certification Division may consider misleading or unauthorized; e) upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division; f) use certification only to indicate the products are certified as being in conformity with specified standards; g) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner; h) ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division; Huntleigh Heaithcare Umited • Diagnostic Products DMsJon • 35 Portmanmoor Road • Cardiff • CF24 5HN • United Kngdom Tel: i-44 (0)29 2048 5885 • Fax: ÷44 (0)29 2049 2520 • Mail: [email protected] • www.huntl&gh-diagnostics.com n ARJOHUNThEIGH COMPANY, VAT Reg: 08382474 600 • Rogistorod No: 942245 England 8 Walos. Registwed Offlca A~pj.,doçii I-bose. l-lot4iton flail Realness Pail.. Hooglalon Regis. Bodlord&*e 11)5 SIP MEMBER OF ThE GETINQE GROUP HUNTLEICH i) keep a record of all complaints made known to the us relating to the product’s compliance with requirements of the relevant standard and to make these records available to the Certification Division when requested; j) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification; k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Greg Baily Technical Director Huntleigh Healthcare Limited, Diagnostic Products Division Huntleigh Hesithoare Umited • Diagnostic Products DMsion • 35 Portmanmoor Road • Cardiff • Cr24 5HN • United Kngdorn Tel: +44 (0)29 2048 5885 • Fax: +44 (0)29 2049 2520 • Mail: [email protected] • w.vw.huntleigh-diagnostics.com ~ ~ COMPANY, VAT Beg: CS 382 474 = • Reg~1eced No: 942245 England & Wales. Regist&ad Office: Asjolhi~elgh House, Hougluton I-~ Bt~ess Path. Hot4utoo Regis. 8edfc.d~*e, [.1)5 5)~ MEMBER OF ThE GETSUGE GRoup

HUNTLEIGH Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject: Request for Confidentiality Models: SF1-SL, (FCC ID: 2ABOQ SF1SL) SF1-US, (FCC ID: 2ABOQ SF1US) SF1-TOCO (FCC ID: 2ABOQ-SF1TOCO) To Whom It May Concern: Pursuant to the provisions of Sections 0.457 and 0.459 of the Commission’s rules (47 CFR §~ 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. • Schematic Diagram • Block Diagram • Theory of Operation • Parts List “as part of schematic” Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Best Regards Greg Baily Technical Director Huntleigh Healthcare Limited, Diagnostic Products Division June 23, 2014 Huntleigh Heaithcare Limited • Diagnostic Products Division • 35 Portmanmoor Road • Cardiff • CF24 5HN • United Kingdom Tel: +44 (0)29 2048 5885 • Fax: +44 (0)29 2049 2520 • Mail: [email protected] • .huntleigh-diagnostics.com , ~ COMPANY. VAT Reg: GB 382 474 600 • Registered P~ 94 45 Er~d 8 WOJBE. Ro~tered 04e38: P4ofh,lIelgFi -louse. Ho4ue, Hil Glisness Peslc Haol~ Regt Oedlordst~e LI.J5 5W MEMBER OF ThEGETINGE GROUP

FCC Submission Document Huntleigh Healthcare Ltd Sonicaid Freedom Appendix 6. 3 Issue Number: 01 Receiver Unit Front View (Labelling shown is for European Product - Refer Appendix 8) FCC Submission Document Huntleigh Healthcare Ltd Sonicaid Freedom Appendix 6. 4 Issue Number: 01 Front View (Labelling shown is for European Product - Refer Appendix 8) Transducers Docked Transducers Un-Docked FCC Submission Document Huntleigh Healthcare Ltd Sonicaid Freedom Appendix 6. 5 Issue Number: 01 Rear View (Labelling shown is for European Product - Refer Appendix 8)

CTG Made in UK SF1-SL IP30 SF1 TM sonicaidFreedom ...performance for life SF1 TOCOUS Freedom US Label Set 778348-J Rear Panel Label Background: Pantone Cool Grey 1C Text and Graphics: Blue Pantone 286C Clear Window 34 x 5.6 2 holes 6.7 (shown solid black) 1 hole 12.5 (shown solid black) Front Panel Label Background: Pantone Cool Grey 1C Text and Graphics: Pantone Blue 286C, Pantone Orange144C & Cool Grey 9C Top Panel Label Background: Pantone Cool Grey 1C Text and Graphics: Pantone Blue 286C, Transmission Status Indicator Battery Status Indicator Manufacturer US Ultrasound Transducer TOCO Tocodynamometer Transducer SYMBOLS Alternative Current (AC) Cardiotocography CTG CTG Cable Connection Warning (refer IFU) Serial Number Model Number Antenna Connection Protection Level IPXX Double Insulated Read IFU On/O Symbol (Transducer) Type CF Applied Part Refer IFU ~ Huntleigh Healthcare Ltd. Diagnostic Products Division 35 Portmanmoor Road, Cardiff, CF24 5HN, U.K. Tel: +44 (0)29 20485885 Fax: -44 (0) 29 20492520 www.huntleigh-diagnostics.com Reciever Unit FCC ID: 2ABOQ-SF1SL IC ID: 11744A-SF1SL Model: SF1-SL This device complies with part 15 of the FCC/IC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service. 100-240V 10-20VA 50-60Hz ~ EXXXXXX ! ! !

FCC Submission Document Huntleigh Healthcare Ltd Sonicaid Freedom Appendix 7. 2 Issue Number: 01 Receiver PCB’s Freedom Base Station PCB Side A Freedom Base Station PCB Side A FCC Submission Document Huntleigh Healthcare Ltd Sonicaid Freedom Appendix 7. 3 Issue Number: 01 Freedom Receiver LED PCB Side A Freedom Receiver LED PCB Side B FCC Submission Document Huntleigh Healthcare Ltd Sonicaid Freedom Appendix 7. 4 Issue Number: 01 Freedom Receiver Charge PCB Side A Freedom Receiver Charge PCB Side A

FCC 47 CFR PART 15 SUBPART C INDUSTRY CANADA RSS-210 ISSUE 8 CERTIFICATION TEST REPORT FOR Sonicaid Freedom SF1-SL MODEL NUMBER: SF1-SL FCC ID: 2ABOQ-SF1SL IC: 11744A-SF1SL REPORT NUMBER: 7554936A ISSUE DATE: April 17, 2014 Prepared for Huntleigh Diagnostics 35 Portmanmoor Road Cardiff CF24 5HN, United Kingdom Prepared by UL VERIFICATION SERVICES INC. 333 Pfingsten Road Northbrook, IL 60062 TEL: (847) 272-8800 REPORT NO: 7554936A DATE: April 17, 2014 FCC ID: 2ABOQ-SF1SL IC: 11744A-SF1SL Page 2 of 29 UL VERIFICATION SERVICES INC. 333 Pfingsten Road, Northbrook, IL 60062 TEL: (847) 272-8800 This report shall not be reproduced except in full, without the written approval of UL Verification Services Inc. Revision History Rev. Issue Date Revisions Revised By -- April 17, 2014 Initial Issue BM REPORT NO: 7554936A DATE: April 17, 2014 FCC ID: 2ABOQ-SF1SL IC: 11744A-SF1SL Page 3 of 29 UL VERIFICATION SERVICES INC. 333 Pfingsten Road, Northbrook, IL 60062 TEL: (847) 272-8800 This report shall not be reproduced except in full, without the written approval of UL Verification Services Inc. TABLE OF CONTENTS 1. ATTESTATION OF TEST RESULTS ....................................................................................................................... 4 2. TEST METHODOLOGY ............................................................................................................................................ 5 3. FACILITIES AND ACCREDITATION..................................................................................................................... 5 4. CALIBRATION AND UNCERTAINTY .................................................................................................................... 5 4.1. MEASURING INSTRUMENT CALIBRATION ....................................................................................................... 5 4.2. SAMPLE CALCULATION ...................................................................................................................................... 5 4.3. MEASUREMENT UNCERTAINTY ......................................................................................................................... 5 5.6. DESCRIPTION OF TEST SETUP .......................................................................................................................... 7 6. TEST AND MEASUREMENT EQUIPMENT .......................................................................................................... 8 7. TEST RESULTS ........................................................................................................................................................... 9 7.1.1. 99% BANDWIDTH and 20dB BW ................................................................................................................ 9 7.1.2. Duty Cycle .................................................................................................................................................... 12 7.1.3. FUNDAMENTAL FREQUENCY RADIATED EMISSION ...................................................................... 13 7.1.4. HARMONICS AND SPURIOUS EMISSIONS ABOVE 1GHz ................................................................. 14 7.1.5. WORST-CASE BELOW 1 GHz .................................................................................................................. 18 8. AC MAINS LINE CONDUCTED EMISSIONS ...................................................................................................... 22 9. SETUP PHOTOS ........................................................................................................................................................ 26 REPORT NO: 7554936A DATE: April 17, 2014 FCC ID: 2ABOQ-SF1SL IC: 11744A-SF1SL Page 4 of 29 UL VERIFICATION SERVICES INC. 333 Pfingsten Road, Northbrook, IL 60062 TEL: (847) 272-8800 This report shall not be reproduced except in full, without the written approval of UL Verification Services Inc. 1. ATTESTATION OF TEST RESULTS COMPANY NAME: Huntleigh Diagnostics 35 Portmanmoor Road Cardiff CF24 5HN, United Kingdom EUT DESCRIPTION: Wireless Fetal Monitoring Solution (Receiver Base Unit) MODEL: SF1-SL SERIAL NUMBER: Prototype DATE TESTED: October 2013 to February 2014 APPLICABLE STANDARDS STANDARD TEST RESULTS CFR 47 Part 15 Subpart C Pass INDUSTRY CANADA RSS-210 Issue 8 Annex 8 Pass INDUSTRY CANADA RSS-GEN Issue 3 Pass UL Verification Services Inc. tested the above equipment in accordance with the requirements set forth in the above standards. All indications of Pass/Fail in this report are opinions expressed by UL Verification Services Inc. based on interpretations and/or observations of test results. Measurement Uncertainties were not taken into account and are published for informational purposes only. The test results show that the equipment tested is capable of demonstrating compliance with the requirements as documented in this report. Note: The results documented in this report apply only to the tested sample, under the conditions and modes of operation as described herein. This document may not be altered or revised in any way unless done so by UL Verification Services Inc. and all revisions are duly noted in the revisions section. Any alteration of this document not carried out byUL Verification Services Inc. will constitute fraud and shall nullify the document. This report must not be used by the client to claim product certification, approval, or endorsement by NVLAP, NIST, any agency of the Federal Government, or any agency of any government. Approved & Released For UL Verification Services Inc. By: Tested By: Michael Ferrer Bartlomiej Mucha EMC Engineer EMC ENGINEER UL Verification Services Inc. UL Verification Services Inc. REPORT NO: 7554936A DATE: April 17, 2014 FCC ID: 2ABOQ-SF1SL IC: 11744A-SF1SL Page 5 of 29 UL VERIFICATION SERVICES INC. 333 Pfingsten Road, Northbrook, IL 60062 TEL: (847) 272-8800 This report shall not be reproduced except in full, without the …

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REPORT NO: 7554936A DATE: April 17, 2014 FCC ID: 2ABOQ-SF1UNITSL IC: 11744A-SF1UNITSL Page 27 of 30 UL VERIFICATION SERVICES INC. 333 Pfingsten Road, Northbrook, IL 60062 TEL: (847) 272-8800 This report shall not be reproduced except in full, without the written approval of UL Verification Services Inc. 9. SETUP PHOTOS Radiated Emissions REPORT NO: 7554936A DATE: April 17, 2014 FCC ID: 2ABOQ-SF1UNITSL IC: 11744A-SF1UNITSL Page 28 of 30 UL VERIFICATION SERVICES INC. 333 Pfingsten Road, Northbrook, IL 60062 TEL: (847) 272-8800 This report shall not be reproduced except in full, without the written approval of UL Verification Services Inc. Radiated Emissions – Antenna Vertical (Not used for 2.4GHz Testing) REPORT NO: 7554936A DATE: April 17, 2014 FCC ID: 2ABOQ-SF1UNITSL IC: 11744A-SF1UNITSL Page 29 of 30 UL VERIFICATION SERVICES INC. 333 Pfingsten Road, Northbrook, IL 60062 TEL: (847) 272-8800 This report shall not be reproduced except in full, without the written approval of UL Verification Services Inc. Line Conducted Emissions