SQ6VSPSVital Signs Patch

1 Dear LifeWatch Technologies Ltd. device owner: Thank you for selecting the LifeWatch Technologies Ltd. Vital Signs Patch (VSP) device, CG-1101XX (models CG-1101U, CG-1101B, CG-1101UC). Please read this user guide before you start using your new device. The guide contains important information about your device as well as clear instructions about how to use it. If you have any questions about the new Vital Signs Patch, please contact: Customer Service at: 2 Copyright Declaration Copyright © 2013 LifeWatch Technologies Ltd.® All rights reserved. LifeWatch Technologies Ltd., LifeWatch Technologies Ltd. logo, LifeWatch Inc., LifeWatch Inc. logo, Vital Signs Patch System are trademarks or registered trademarks of LifeWatch Technologies Ltd.®. All other brand names and product names used in this document are trade names, service marks, trademarks, or registered trademarks of their respective owners. The information and screens provided in this manual are subject to change without notice. LifeWatch Technologies Ltd. SHALL NOT BE LIABLE FOR TECHNICAL OR EDITORIAL ERRORS OR OMISSIONS CONTAINED HEREIN; NOR FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS MATERIAL. Authorized representatives: Europe Obelis s.a Boulevard Général Wahis 53 1030 Brussels, BELGIUM Tel: + (32) 2. 732.59.54 Fax: + (32) 2.732.60.03 E-mail: [email protected] USA LifeWatch, Inc. O’Hare International Center 10255 West Higgins Road Suite 120 Rosemont, IL 60018 Tel: 847-720-2295 Fax: 847-720-1995 Toll Free: 800-633-3361 Fax: 800-954-2375 Email: [email protected] Israel LifeWatch Technologies Ltd. 2 Pekeris St. Rehovot 7670202 Israel Tel: 972 8 9484000 Fax: 972 8 9484044 Email: [email protected] Before using the VSP System please read and Precautions in Appendix A and the Contraindications on pages 5 and 6. LifeWatch Technologies Ltd.® All rights reserved. LifeWatch Technologies Ltd., LifeWatch Technologies Ltd. logo, Vital Signs Patch System and VSP are trademarks or registered trademarks All other brand names and product names used in this document are trade names, service marks, trademarks, or registered trademarks of their The information and screens provided in this manual are subject to feWatch Technologies Ltd. SHALL NOT BE LIABLE FOR TECHNICAL OR EDITORIAL ERRORS OR OMISSIONS CONTAINED HEREIN; NOR FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE FURNISHING, PERFORMANCE, OR USE OF THIS LifeWatch Technologies Ltd. 7670202 Tel: 972 8 9484000 Fax: 972 8 9484044 Email: [email protected] please read the Warnings 3 Declaration of Conformity The VSP System consists of a disposable patch, a reusable processing unit and a Smartphone based application.  The VSP System is classified as internally powered equipment with type BF applied parts.  The device is suitable for continuous operation.  The Patch (CG-1101XX) is classified as type IP54 equipment affords protection against dust and splashing water.  The VSP System is classified by the MDD as a Class IIa (Pulse oximeter; ECG; Heart Rate; Body Temperature) The VSP System is compliant with IEC 60601-1:2005 IEC 60601-1-2:2007; however this does not preclude the possibility of electronic interference from other equipment where the device will need to be activated at a distance from the source(s) of interference. LifeWatch Technologies’ Quality System (QS) certified to ISO-9001:2008, ISO 13485:2003 CE 93/42 MDD and Canadian QS Requirements WARNING No modification of this equipment is allowed Refer servicing to qualified personnel only. DANGER Equipment not suitable for use in the presence of anesthetic mixture with air or with Oxygen or Nitrous Oxide. Federal Law (USA) restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use or order the use of the device. disposable patch, a reusable processing unit and a Smartphone based application. internally powered equipment with equipment which dust and splashing water. Class IIa device Body Temperature) :2005 and however this does not preclude the possibility of electronic interference from other equipment where the device will need to be activated at a distance from the source(s) of (QS) is 9001:2008, ISO 13485:2003 Requirements Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with Oxygen or Nitrous Oxide. Federal Law (USA) restricts this device to sale by or on the order of a practitioner licensed by the law of the State in which he/she practices to use 4 Graphic Symbols on VSP System Label Description Warning Precaution Notes; indicates important general information for using the system successfully. Refer to instruction manual/ booklet NOTE: On ME EQUIPMENT "Follow instructions for use.” XXXX Manufacturer and date of manufacture Type BF Applied Part Indicates the temperature limits for storage of the device. WEEE Directive for disposal of Electrical and Electronic Equipment Symbol for no SPO 2 alarms Warning Under no circumstances should you interpret your heart rate, temperature, saturation or respiration vital signs or accelerometer data nor take any actions of a medical nature based on your understanding UNLESS you are a medical professional. indicates important general information for Refer to instruction manual/ booklet NOTE: On ME EQUIPMENT "Follow instructions anufacture for storage of the WEEE Directive for disposal of Electrical and heart rate, body vital signs or accelerometer nor take any actions of a medical nature based on your understanding UNLESS you are a medical professional. 5 Intended Use The Vital Signs Patch system is intended to be used by patients for the continuous, non-invasive monitoring of ECG, Heart Rate (HR), respiration, body temperature and blood saturation, when prescribed by a physician or other qualified healthcare professional. The VSP includes pacemaker detection to show pulses of pacemaker on the screen and can ther…

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External photos

DATE OF ISSUE DATE OF DWG A 4 SIGN. 28 mm 21 mm 01 02489 INITIAL 04-03-13 LifeWatch Technologies Ltd. 2 Pekeris St. Rehovot 7670202 ISRAEL VSP Transmitter 2013 1:1 Revision ECO Reason Date VSP System patches (CG-1101XX) LifeWatch Technologies Ltd. SHEET 1 OF 1 BRAIN Label DWG N0. LA-00068 DWG Operations manager PROJECT N0. DAVID K Benny Tal Nina C ASSY REV. DWG REV. 04 SCALE ----- CHKD Project manager Shimon M NOTE: barcode is comprised of the following information: xx |xx| xx | xxxx ww|yy|product code|serial number FGL-XXXXX DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC Pantone 7462 C Pantone White C Notes: 1. Generic logo, material metalized polyester 2. Solvent resistant 3. Background color: Silver 4. Print color: Black except for symbol 5. Part# font: Arial 6. Serial# font: Arial 7. Device version# font: Arial 8. FG number determines which version of CG-1101XX FCC ID: SQ6VSPS LifeWatch Technologies Ltd. 2 Pekeris St. Rehovot 7670202 ISRAEL VSP Transmitter 2013 FGL-XXXXX DO NOT USE IN THE PRESENCE OF FLAMMABLE ANESTHETIC FCC ID: SQ6VSPS Example 02 02518 Added FCC # 03-04-13 xxxxxxxxxx xxxxxxxxxx 03 02566 Added SN code 04-06-13 IP54 IP54 04 02579 Remove FCC logo 30-06-13

Internal photos

Test Report No. 9312308467 Applicant : LifeWatch Technologies Ltd. Equipment Under Test: Vital Signs Patch Models: CG1101B, CG1101U and CG1101UC FCC ID: SQ6VSPS From The Standards Institution Of Israel Industry Division Electronics & Telematics Laboratory EMC Branch ACLASS Accreditation Services Certificate Number: AT-1359 Test Report No.: 9312308467 Page 1 of 45 pages Title: Vital Signs Patch Model: CG1101B, CG1101U and CG1101UC FCC ID: SQ6VSPS Description of Equipment Under Test (EUT): Vital Signs Patch. Models: CG1101B, CG1101U and CG1101UC Software version of brain unit 0.4.0.1 Hardware version of brain unit MAL-00021 rev.0B Serial Number: N/A Manufactured by: LifeWatch Technologies Ltd. Reference Documents:  CFR 47 FCC: Rules and Regulations; Part 15. “Radio frequency devices”; Subpart B: “Unintentional radiators” (2009). Section 15.109. “Radiated emission limits”. Subpart C : “Intentional radiators” (2009). Section 15.209. “Radiated emission limits, general requirements”. “Radiated Emission Limits, Additional Provisions”; Section 15.249. “Operation within the bands 902 – 928 MHz, 2400 – 2483.5 MHz, 5725 – 5875 MHz and 24.0 - 24.25 GHz”. Applicant: LifeWatch Technologies Ltd. Address: 2 Pekeris St., POB 7670202, Rehovot, Israel Sample for test selected by: The customer The date of tests: 22 April, 1 May 2013 This Test Report contains 45 pages and may be used only in full. This Test Report applies only to the specimen tested and may not be applied to other specimens of the same product. Test Report No.: 9312308467 Page 2 of 45 pages Title: Vital Signs Patch Model: CG1101B, CG1101U and CG1101UC FCC ID: SQ6VSPS Table of Contents 1. EUT Description and operation 3 1.1. General description: 3 2. Test summary 4 2.1. Potential emission sources: 7 2.2. EUT setup and operation: 7 3. Measurements, examinations and derived results 7 3.1. Location of the Test Site: 7 3.2. Test condition: 7 3.3. Initial visual check and functional test: 7 3.4. Radiated emission test. 8 3.5. Test of field strength emission from intentional radiator. 9 3.6. Test of occupied bandwidth per 15.215(c) 38 4. Appendix 1. Test equipment used 39 5. Appendix 2: Antenna Factor and Cable Loss 40 6. Appendix 3: Test setups photo. 45 Test Report No.: 9312308467 Page 3 of 45 pages Title: Vital Signs Patch Model: CG1101B, CG1101U and CG1101UC FCC ID: SQ6VSPS 1. EUT Description and operation 1.1. General description: * Note: the customer supplied all information in clause below. The EUT, Vital Signs Patch system, is intended to be used by patients for the continuous, non- invasive monitoring of ECG, Heart Rate (HR), respiration, body temperature, and blood saturation when prescribed by a physician or other qualified healthcare professional. Three Patch model were presented for tests: CG1101B, CG1101U and CG1101UC. A Main Processing Unit (Brain) plugs into a cradle on the Patch with a 16-pin connector. The Brain receives the power from the Patch’s battery. The data from the sensors are transmitted using the 16-pin connector. The Brain transmits data to the Gateway application using the RF component. The patient can manually trigger an event by the pressing a button on the Brain. In addition, the Brain contains a 32MB Flash memory chip that can store 8-10 hours of data in case of communication failure with the Gateway. Type of modulation: GFSK Antenna type: Internal on PCB The EUT power source: 3.0 VDC Lithium battery. The EUT external views are presented in photo # 1-5. Test Report No.: 9312308467 Page 4 of 45 pages Title: Vital Signs Patch Model: CG1101B, CG1101U and CG1101UC FCC ID: SQ6VSPS 2. Test summary Parameter FCC Part 15 Reference paragraph Verdict Radiated emission test on unintentional radiator. Subpart B Section 15.109 Comply Test of field strength emission from intentional radiators “Radiated Emission Limits, Additional Provisions”; Section 15.249. Comply Conducted emission test. Subpart C Section 15.207 N/A Electronics & Telematics Laboratory July 2013 Name: Eng. Yuri Rozenberg Name: Michael Feldman Position: Head of EMC Branch Position: Test Technician Measurement uncertainty. Were relevant, the following measurement uncertainty level have been estimated for tests performed on the EUT as specified in CISPR 16-4-2: This uncertainty represents an expended uncertainty expressed at approximately the 95% confidence level using a coverage factor of k=2. Test description Expanded uncertainty Radiated emissions in the open field test site at 3 m measuring distance: 30 MHz – 1.0 GHz 1.0 GHz – 18 GHz 2 Uc (E) =  4.32 dB 2 Uc (E) =  4.47 dB Test Report No.: 9312308467 Page 5 of 45 pages Title: Vital Signs Patch Model: CG1101B, CG1101U and CG1101UC FCC ID: SQ6VSPS Photo 1. Brain external front and rear view Photo 2. Patch external view Test Report No.: 9312308467 Page 6 of 45 pages Title: Vital Signs Patch Model: CG1101B, CG1101U and CG1101UC FCC ID: SQ6VSPS Photo 3. Model CG-1101B. Photo 4. Model CG-1101U. Photo 5. Model CG-1101UC. Test Report No.: 9312308467 Page 7 of 45 pages Title: Vital Signs Patch Model: CG1101B, CG1101U and CG1101UC FCC ID: SQ6VSPS 2.1. Potential emission sources: The potential emission sources are detailed in Table 1. Table 1. Potential emission sources Frequency Location 16.384 MHz Microcontroller oscillator 16.0 MHz RF Lo oscillator 2404 - 2480 MHz RF signal 2.2. EUT setup and operation: Respective tests were performed in transmission (Tx) and receive modes. Test was performed for three patch models: CG1101B, CG1101U and CG1101UC. Radiated emission test was performed at three points - low 2404 MHz, middle 2440 MHz and top 2480 MHz of 2400 – 2483.5 MHz frequency band. Measurements of transmitter were performed in continue transmit mode. 3. Measurements, examinations and derived results 3.1. Location of the Test Site: Preliminary radiated test was conducted at the EMC laboratory of the Standards Institution of Israel in Tel-Aviv. Final tests were conducted in an Open Area Test Site located at Kibbutz…

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Test set up photos RE test setup RE test setup RE test setup