X5J-RSTM-DVMDyna-Vision/TeleSentry

Copyright © RS TechMedic BV. All rights reserved. Page 1 Dyna-Vision© Unit Instructions for Use RS TechMedic BV Broeker Werf 6 1721 PC Broek op Langedijk The Netherlands Version: 4.66 0344 Copyright © RS TechMedic BV. All rights reserved. Page 2 CONTENTS Introduction ............................................................................................................................................................ 4 Intended use ........................................................................................................................................................... 5 Warnings and cautions ........................................................................................................................................ 5 Precautions and limitations: ............................................................................................................................... 5 Liability Notice ......................................................................................................................................................... 6 Terms of Warranty .................................................................................................................................................. 6 Copyright ................................................................................................................................................................. 7 Getting Help ............................................................................................................................................................ 7 Dyna-Vision specifications ...................................................................................................................................... 8 Device .................................................................................................................................................................. 8 ECG ...................................................................................................................................................................... 8 SPO2 .................................................................................................................................................................... 8 Bluetooth ............................................................................................................................................................ 8 Gsm/gprs ............................................................................................................................................................. 8 USB ...................................................................................................................................................................... 9 End of life statement ........................................................................................................................................... 9 Parts ...................................................................................................................................................................... 10 Dyna-Vision© unit ............................................................................................................................................. 10 There are 4 article codes possible: ................................................................................................................ 10 Serial number ................................................................................................................................................ 10 ECG cable .......................................................................................................................................................... 11 ECG electrodes .................................................................................................................................................. 11 Spo2 cable ......................................................................................................................................................... 11 USB cable........................................................................................................................................................... 12 Power Supply unit ............................................................................................................................................. 12 Accessories ........................................................................................................................................................ 13 Connecting the ECG cable and sensors ................................................................................................................. 14 Connecting the cable to the patient ................................................................................................................. 14 Copyright © RS TechMedic BV. All rights reserved. Page 3 3-lead configuration .......................................................................................................................................... 15 5-lead configuration .......................................................................................................................................... 15 12-lead configuration ........................................................................................................................................ 15 PLACEMENT OF THE ELECTRODES ........................................................................................................................ 16 Other configurations ......................................................................................................................................... 17 Connecting the cable to the device ................................................................................................................... 17 3, 5 or 12 lead connection ports ..................................…

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RS TechMedic B.V. - Broeker Werf 6 - 1721PC Broek op Langedijk - The Netherlands Tel: +31 (0)226 342044 - Fax: +31 (0)226-341446 - www.rstechmedic.com - [email protected] Rabobank Alkmaar: 10.33.92.165 - KvK / CoC: 37136895 - BTW / VAT: NL8186.38.667.B01 DECLARATION Broek op Langedijk, May 28., 2010 RS TechMedic B.V. Broeker Werf 6 1721 PC Broek op Langedijk The Netherlands Hereby declares: The module used by us the Q2687 produced by Sierra Wireless, software with AT command AT + WMBS = 4.1 is fixed on US dual band mode 850/1900 MHz. Therefor it is not possible to send on non US-bands. As the software is embedded in the internal microcontroller is it not possible for third parties to change these settings. Sander Huntelerslag CTO

Product Specification 5 Little Balmer Buckingham Industrial Park Buckingham MK18 1TF UK Tel: +44 (0)1280 824055 Fax: +44 (0)1280 817179 Email: [email protected] Web: www.ead-ltd.com Specifications subject to change without notice. Specifications Radiating element1/4 Wave Element Frequency range850/900/1800/1900 MHz Peak gain0 dBi Polarisation Linear Return loss-6.0 dB Power rating 10W Cable / ConnectorVarious including MMCX, U.FL, SMA Dimensions44 x 8mm Popular Ordering Options FMQ35094-MR-10Mini-Quad with 100mm RG-178 and MMCX Connector FMQ35094-UF-10Mini-Quad with 100mm cable and U.FL Connector Features w Groundplane Dependent w Covers 850/900/1800/1900 MHz bands w Various cable/connector options w Ideal for mobile devices Mini-Quad Quad Band Internal PCB Antenna Delivering Antenna Innovation Return Loss Outline Drawing 5 Little Balmer Buckingham Industrial Park Buckingham MK18 1TF UK Tel: +44 (0)1280 824055 Fax: +44 (0)1280 817179 Email: [email protected] Web: www.ead-ltd.com www.ead-ltd.com Specifications subject to change without notice. Mini-Quad| Quad Band Internal PCB Antenna Delivering Antenna Innovation

2010 Sierra Wireless Inc. This document contains information which is proprietary and confidential to Sierra Wireless Inc. Disclosure to persons other than the officers, employees, agents, or subcontractors of the Company without the prior written permission of Sierra Wireless Inc. is strictly prohibited. The range of allowable operating power levels used by the Q2687 are defined as per the tables below Range of operating RF power levels for GSM 1900 (PCS) Power Control Level Signal Tolerances dBm Normal Extreme 0 30 +/-2 dB +/-2.5 dB 1 28 +/-3 dB +/-4 dB 2 26 +/-3 dB +/-4 dB 3 24 +/-3 dB +/-4 dB 4 22 +/-3 dB +/-4 dB 5 20 +/-3 dB +/-4 dB 6 18 +/-3 dB +/-4 dB 7 16 +/-3 dB +/-4 dB 8 14 +/-3 dB +/-4 dB 9 12 +/-4 dB +/-5 dB 10 10 +/-4 dB +/-5 dB 11 8 +/-4 dB +/-5 dB 12 6 +/-4 dB +/-5 dB 13 4 +/-4 dB +/-5 dB 14 2 +/-5 dB +/-6 dB 15 0 +/-5 dB +/-6 dB Range of operating RF power levels for GSM 850 Power Control Level Signal Tolerances dBm Normal Extreme 5 33 +/-2 dB +/-2.5 dB 6 31 +/-3 dB +/-4 dB 7 29 +/-3 dB +/-4 dB 8 27 +/-3 dB +/-4 dB 9 25 +/-3 dB +/-4 dB 10 23 +/-3 dB +/-4 dB 11 21 +/-3 dB +/-4 dB 12 19 +/-3 dB +/-4 dB 13 17 +/-3 dB +/-4 dB 14 15 +/-3 dB +/-4 dB 15 13 +/-3 dB +/-4 dB 16 11 +/-5 dB +/-6 dB 17 9 +/-5 dB +/-6 dB 18 7 +/-5 dB +/-6 dB

FCC,Requestfornon-diselosure RF_501,Issue4 Date:12-Mar-09 Page1 of1 CompanyName: Address: City: Country: RSTechMedicBV SroekerWerf6 BroekopLangedijk TheNetherlands To:TeleficationB.V.,Dept.FCCTCB Edisonstraat12A 6902PKZEVENAAR TheNetherlands Subject:RequestforconfidentialityFCCID:X5J-RSTM-DVM Referencenumber:20094106-0 DearFCCTCB, 1. Long-TermConfidentiality Pursuantto47CFRSeetion0.459(a)& (b),weherebyrequestsnon-disclosureandconfidentialtreatment ofthefollowingmaterialssubmiUedin supportofFCCcertificationapplication: [8]Bill(s)ofMaterial[8]BlockDiagrams [8]OperationalDescription[8]SchematicDiagrams Abovematerialscontainseerets,proprietaryandtechnicalinformation,whichwouldcustomarilybe guardedfromcompetitorsunder47CFR,section0.457(d)(2).Disclosureorpublicationoranyportionof thiscompanyconfidentialmaterialtootherpartieseouldcausesubstantialcompetitiveharmandprovide unjustifiedbenefitsforcompetitors. 2. Short-TermConfidentiality(STC) PursuanttoPublicNotieeDA04-1705oftheCommission'spolicy,inordertocomplywiththemarketing regulationsin47CFR§2.803andtheimportationrulesin 47CFR§2.1204,applicantherebyrequests Short-TermConfidentialtreatmentofthefollowingmaterials(note1): o Tune-upProcedure o ExternalPhotos o InternalPhotoso User'sManual o TestSet-upPhotos J ustification: PlannedReleaseDateSTC: (notes2,3, 4,5) Date:29-04-2010 Notes: 1) A documentortype0documenteenonlyhaveONEtypeof oonfidentiality! 2)Shart-Termcantidentialityisin principletor45daystromdateotgrant;lt canbeextendedmax3 times(tota/time180daysmax.)! 3)FCCmustbeintarmedwhenmarketingbeginsearlier. 4)Releasetakesplaceautamaticallythusextensianmustberequestedintime.Te/eficatiandoesnotremindyauotthis! 5)RequesttorextensianortorreleasemustbereceivedbyTe/eticationatleast7 daysbetaredateotactua/marketingorbetare expirationoi theSTCperiad

Photographs module 20094106PME External PHOTOGRAPH 1: FRONT VIEW .......................................................................................................................... 2 PHOTOGRAPH 2: REAR VIEW ............................................................................................................................ 3 PHOTOGRAPH 3: CONNECTIONS, PATIENT TERMINALS .................................................................................... 4 PHOTOGRAPH 4: CONNECTIONS, USB AND POWER SUPPLY ............................................................................ 5 PHOTOGRAPH 5: POWER SUPPLY, OVERVIEW .................................................................................................. 6 PHOTOGRAPH 6: POWER SUPPLY, FRONT ......................................................................................................... 7 PHOTOGRAPH 7: POWER SUPPLY, REAR ........................................................................................................... 8 PHOTOGRAPH 8: POWER SUPPLY, TYPE PLATE ................................................................................................. 9 Page: 2 of 9 Report number: 20094106PME Photograph 1: Front view Page: 3 of 9 Report number: 20094106PME Photograph 2: Rear view Page: 4 of 9 Report number: 20094106PME Photograph 3: Connections, patient terminals Page: 5 of 9 Report number: 20094106PME Photograph 4: Connections, USB and power supply Page: 6 of 9 Report number: 20094106PME Photograph 5: Power supply, overview Page: 7 of 9 Report number: 20094106PME Photograph 6: Power supply, front Page: 8 of 9 Report number: 20094106PME Photograph 7: Power supply, rear Page: 9 of 9 Report number: 20094106PME Photograph 8: Power supply, type plate

Photographs module 20094106-PMI Internal PHOTOGRAPH 1: INSIDE OVERVIEW ................................................................................................................. 2 PHOTOGRAPH 2: INSIDE VIEW, TOP PART WITH PCB ........................................................................................ 3 PHOTOGRAPH 3: INSIDE VIEW, BOTTOM PART WITH BATTERY ......................................................................... 4 PHOTOGRAPH 4: PCB, DETAIL OF BLUETOOTH MODULE.................................................................................. 5 PHOTOGRAPH 5: PCB, DETAIL OF GPRS MODEM ............................................................................................ 6 Page: 2 of 6 Report number: 20094106PMI Photograph 1: Inside overview Page: 3 of 6 Report number: 20094106PMI Photograph 2: Inside view, top part with PCB Page: 4 of 6 Report number: 20094106PMI Photograph 3: Inside view, bottom part with battery Page: 5 of 6 Report number: 20094106PMI Photograph 4: PCB, detail of bluetooth module Page: 6 of 6 Report number: 20094106PMI Photograph 5: PCB, detail of GPRS modem

TEST REPORT FROM RFI GLOBAL SERVICES LTD Test of: R&S TechMedic BV Dyna-Vision DVM-012SG To: OET Bulletin 65 Supplement C: (2001-01) Test Report Serial No: RFI/SAR2/RP77230JD05A Supersedes Test Report Serial No: RFI/SAR1/RP77230JD05A This Test Report Is Issued Under The Authority Of Scott D’Adamo, Operations Manager Global Approvals pp Checked By: Richelieu Quoi Report Copy No: PDF01 Issue Date: 13 May 2010 Test Dates: 29 March to 11 May 2010 "The Bluetooth® word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by RFI Global Services Ltd. is under license. Other trademarks and trade names are those of their respective owners." This report is issued in Adobe Acrobat portable document format (PDF). It is only a valid copy of the report if it is being viewed in PDF format with the following security options not allowed: Changing the document, Selecting text and graphics, Adding or changing notes and form fields. This report may be copied in full. The results in this report apply only to the sample(s) tested. RFI GLOBAL SERVICES LTD Test Report Serial No: RFI/SAR2/RP77230JD05A Page: 2 of 47 Issue Date: 13 May 2010 Test of: R&S TechMedic BV Dyna-Vision DVM-012SG To: OET Bulletin 65 Supplement C: (2001-01) This page has been left intentionally blank. RFI GLOBAL SERVICES LTD Test Report Serial No: RFI/SAR2/RP77230JD05A Page: 3 of 47 Issue Date: 13 May 2010 Test of: R&S TechMedic BV Dyna-Vision DVM-012SG To: OET Bulletin 65 Supplement C: (2001-01) Table of Contents 1. Customer Information ...................................................................................................... 4 2. Equipment Under Test (EUT) ........................................................................................... 5 3. Test Specification, Methods and Procedures ................................................................ 8 4. Deviations from the Test Specification .......................................................................... 9 5. Operation and Configuration of the EUT during Testing ............................................ 10 6. Summary of Test Results............................................................................................... 11 7. Measurements, Examinations and Derived Results.................................................... 12 8. Measurement Uncertainty.............................................................................................. 16 Appendix 1. Test Equipment Used.................................................................................... 19 Appendix 2. Measurement Methods ................................................................................. 22 Appendix 3. SAR Distribution Scans ................................................................................ 24 Appendix 4. Photographs .................................................................................................. 32 Appendix 5. Validation of System ..................................................................................... 43 Appendix 6. Simulated Tissues......................................................................................... 44 Appendix 7. DASY4 System Details .................................................................................. 45 RFI GLOBAL SERVICES LTD Test Report Serial No: RFI/SAR2/RP77230JD05A Page: 4 of 47 Issue Date: 13 May 2010 Test of: R&S TechMedic BV Dyna-Vision DVM-012SG To: OET Bulletin 65 Supplement C: (2001-01) 1. Customer Information Company Name: R&S TechMedic BV Address: Broeker Werf 6 1721 PC Broek op Langedijk Langedijk The Netherlands RFI GLOBAL SERVICES LTD Test Report Serial No: RFI/SAR2/RP77230JD05A Page: 5 of 47 Issue Date: 13 May 2010 Test of: R&S TechMedic BV Dyna-Vision DVM-012SG To: OET Bulletin 65 Supplement C: (2001-01) 2. Equipment Under Test (EUT) 2.1. Identification of Equipment Under Test (EUT) Description: Remote Patient Monitor Brand Name: Dyna-Vision Model Name or Number: DVM-012SG Serial Number: DV08Y01B0082 IMEI Number: 359983000890016 Hardware Version Number: 3808 Software Version Number: 3.00 Hardware Revision of GSM Module: None Stated Software Revision of GSM Module: None Stated FCC ID Number: GC145698 Country of Manufacture: The Netherlands Date of Receipt: 11 March 2010 2.2. Description of EUT The equipment under test was a Class IIb medical device, to be used for recording and/or (simultaneous) transmission of Electrocardiography (ECG) and SpO2 signals. The EUT has Bluetooth and GSM/GPRS 850/900/1800/1900 capabilities, with an integral antenna. 2.3. Modifications Incorporated in the EUT There were no modifications incorporated in the EUT. RFI GLOBAL SERVICES LTD Test Report Serial No: RFI/SAR2/RP77230JD05A Page: 6 of 47 Issue Date: 13 May 2010 Test of: R&S TechMedic BV Dyna-Vision DVM-012SG To: OET Bulletin 65 Supplement C: (2001-01) 2.4. Accessories The following accessories were supplied with the EUT during testing: Description: 3 Lead Wire ECG Cable Brand Name: Dyna-Vision Model Name or Number: None Stated Serial Number: 080912-061/ 4680609 Cable Length and Type: ~ 0.5 m Country of Manufacture: None Stated Connected to Port Unique to Manufacturer Description: Carry Case with belt loop Brand Name: Dyna-Vision Model Name or Number: None Stated Serial Number: None Stated Cable Length and Type: Not Applicable Country of Manufacture: None Stated Connected to Port Not Applicable 2.5. Support Equipment The following support equipment was used to exercise the EUT during testing: Description: Communication Test Set Brand Name: Rohde & Schwarz Model Name or Number: CMU200 Serial Number: 116284 Cable Length and Type: ~2.0 m Utiflex RF cable Connected to Port: RF (Input/Output) Air Link RFI GLOBAL SERVICES LTD Test Report Serial No: RFI/SAR2/RP77230JD05A Page: 7 of 47 Issue Date: 13 May 2010 Test of: R&S TechMedic BV Dyna-Vision DVM-012SG To: OET Bulletin 65 Supplement C: (2001-01) 2.6. Additional Information Related to Testing Equipment Cate…

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EMC test report 20094106200 Based on: - FCC part 15; subpart B; section 15.107(a) and 15.109(a): (10-01-08) edition Outdoor Patient Monitor RS TechMedic Dyna-Vision Report number: 20094106200 Contents MAIN MODULE .............................................................................................................................................. 3 1 ...... INTRODUCTION ...................................................................................................................................... 3 2 ...... PRODUCT ............................................................................................................................................... 4 3 ...... TEST SCHEDULE ..................................................................................................................................... 4 4 ...... PRODUCT DOCUMENTATION .................................................................................................................. 5 5 ...... OBSERVATIONS AND COMMENTS ........................................................................................................... 5 6 ...... MODIFICATIONS TO THE SAMPLE ........................................................................................................... 5 7 ...... SUMMARY.............................................................................................................................................. 5 8 ...... CONCLUSIONS ........................................................................................................................................ 6 TEST RESULTS MODULE ........................................................................................................................... 7 1 ...... GENERAL INFORMATION ........................................................................................................................ 7 1.1 Equipment information ..................................................................................................................... 7 2 ...... SUMMARY OF TEST DATA ....................................................................................................................... 7 3 ...... EMISSION TESTS ..................................................................................................................................... 8 3.1 Field strength of unwanted emissions 30 - 1000 MHz (exploratory) ............................................... 8 3.2 Field strength of unwanted emissions 30 - 1000 MHz ................................................................... 10 3.3 AC mains line conducted emissions ............................................................................................... 12 USED TEST EQUIPMENT MODULE ....................................................................................................... 20 This report comprises of three modules. The total number of pages is: 20 Page: 3 of 20 Main module Report number: 20094106200 Main module 1 Introduction This report contains the result of tests performed by: Telefication B.V. Edisonstraat 12a 6902 PK Zevenaar The Netherlands Telefication complies with the accreditation criteria for test laboratories as laid down in ISO/IEC 17025:2005. The accreditation covers the quality system of the laboratory as well as the specific activities as described in the authorized annex bearing the accreditation number L021 and is granted on 30 November 1990 by the Dutch Council For Accreditation (RvA: Raad voor Accreditatie). The contents of this test report, if reproduced, shall be copied in full, unless special consent in writing for reproduction in part is granted by Telefication. Copyright of this test report is reserved to Telefication. Ordering party: Company name : RS TechMedic B.V. Address : Broeker Werf 6 Zipcode : 1721 PC City/town : Broek op Langedijk Country : The Netherlands Date of order : 22 January 2010 Page: 4 of 20 Main module Report number: 20094106200 2 Product A sample of the following product was submitted for testing: Product description : Outdoor Patient Monitor Manufacturer : RS TechMedic Trade mark : Dyna-Vision Type designation : DVM-010SG FCC ID : X5J-RSTM-DVM Hardware version : -- Serial number : DV08Y01B0023 Software release : -- 3 Test schedule Tests are carried out in accordance with the specification detailed in chapter 7 “Summary” of this report. Tests are carried out at the following location:  Telefication, Zevenaar The sample of the product is received on:  25 January 2010 Tests are carried out on:  25 January 2010 Page: 5 of 20 Main module Report number: 20094106200 4 Product documentation For production of this report the following product documentation has been used: Description: Date: Identification: User Manual -- Dyna-Vision Monitor User Manual 4.63 Instructions for Use August 24th 2009 Dyna-Vision Unit Basic Instructions for Use 4.64 The above-mentioned documentation will be filed at Telefication for a period of 10 years following the issue of this test report. 5 Observations and comments It was agreed with the applicant to perform the following tests:  FCC part 15, subpart B section 15.107  FCC part 15, subpart B section 15.109 The EUT incorporates four operational modes: - USB mode for transferring sampled data to a PC; - Bluetooth mode for real time patient monitoring; - GPRS mode for real time patient monitoring; - Holter mode for recording patient data. Measurements are performed in all four modes. 6 Modifications to the sample No modifications were made to the sample. 7 Summary The product is intended for use in the following application area(s): MEDICAL The sample is tested according to the following specification(s): FCC part 15; subpart B; section 15.107(a) and 15.109(a): (10-01-08) edition. Page: 6 of 20 Main module Report number: 20094106200 8 Conclusions The samples of the product showed NO NON-COMPLIANCES to the specification stated in chapter 7 of this report. The results of the …

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CETECOM ICT Services GmbH Untertürkheimer Str. 6-10, 66117 Saarbruecken Phone: +49 (0) 681 598-0 Fax: -9075 RSC-Laboratory Phone: +49 (0) 681 598-0 Fax: -9075 Test report no.: 2-4299-01-02/06 Date: 2006-09-06 Page 1 of 97 Recognized by the Federal Communications Commission Anechoic chamber registration no.: 90462 (FCC) Anechoic chamber registration no.: 3463 (IC) TCB ID: DE 0001 Accredited by the German Accreditation Council DAR–Registration Number DAT-P-176/94-D1 Independent ETSI compliance test house ETSI Accredited Bluetooth ® Test Facility (BQTF) Test report No. : 2-4299-01-02/06 Applicant : Wavecom s. A. Type : Q2687 Test Standard : FCC Part 22, 24 RSS-132, -133 FCC ID : O9EQ2687 Certification No. IC : 3651C- Q2687 The Bluetooth word mark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Cetecom ICT is under license CETECOM ICT Services GmbH Untertürkheimer Str. 6-10, 66117 Saarbruecken Phone: +49 (0) 681 598-0 Fax: -9075 RSC-Laboratory Phone: +49 (0) 681 598-0 Fax: -9075 Test report No.: 2-4299-01-02/06 Date: 2006-09-06 Page 2 of 97 Table of contents 1 GENERAL INFORMATION ................................................................................................................................... 3 1.1. ADMINISTRATIVE DATA OF THE TEST FACILITY..................................................................................................... 3 1.1.1 Identification of the testing laboratory ......................................................................................................... 3 1.2. NOTES................................................................................................................................................................... 3 1.3 DETAILS OF APPLICANT......................................................................................................................................... 4 1.4 APPLICATION DETAILS.......................................................................................................................................... 4 1.5 TEST ITEM............................................................................................................................................................. 5 1.6 TEST SETUP........................................................................................................................................................... 6 1.7 TEST STANDARDS.................................................................................................................................................. 6 2 STATEMENT OF COMPLIANCE .......................................................................................................................... 7 2.1 SUMMARY OF MEASUREMENT RESULTS................................................................................................................ 7 2.1.1 PCS 1900 ...................................................................................................................................................... 7 2.1.2 GSM 850 ....................................................................................................................................................... 7 3 MEASUREMENTS AND RESULTS ....................................................................................................................... 8 3.1 PART PCS 1900 ................................................................................................................................................... 8 3.1.1 RF Power Output ..........................................................................................................................................8 3.1.2 Frequency Stability ..................................................................................................................................... 12 3.1.3 Radiated Emissions..................................................................................................................................... 15 3.1.4 Receiver Radiated Emissions ..............................................................................................................…

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