SEFAM PolyLink Procedure For Installation And Usage

SEFAM PolyLink Procedure For Installation And Usage

Control polygraphy with the s.box device

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Summary of Contents for SEFAM PolyLink

  • Page 2 Manufacturing and technical locations: SEFAM SEFAM 144 AV CHARLES DE GAULLE 10 ALLEE PELLETIER DOISY 92200 NEUILLY SUR SEINE 54600 VILLERS-LES-NANCY FRANCE FRANCE TEL: +33 (0) 3 83 44 85 00 www.Sefam-medical.com Technical assistance: E:mail: technicalservice@sefam-medical.com 2  PolyLink kit...
  • Page 3: Table Of Contents

    Overview of the PolyLink items ........................5 Definition of symbols ............................ 7 Installation .............................. 8 Insertion of the PolyLink module into the S.Box device ................. 8 Implementing the effort/position kit and sensors ................... 8 Recharging the internal battery of the kit ....................9 Use ................................
  • Page 4: Before You Start

    In addition to the clinical examination, the PolyLink kit allows the physician to assess the treatment efficiency of the patient by S.Box Positive Pressure Device.  Keep the S.Box device and the PolyLink kit away from any source of water. Use them only if they are dry and in good working condition. ...
  • Page 5: Description

    WARNING: RF portable communication devices (including equipments such as antenna cables and external antennas) should not be used closer than 30 cm (12 inches) from any part of the PolyLink kit, including cables specified by the manufacturer. Otherwise, the performance of these devices may be affected.
  • Page 6 PolyLink effort/position kit: integrates the position sensor and allows acquisition and transfer of signals of respiratory effort and of body position to the PolyLink module for S.Box. It is powered by an internal battery and fits into a support. ⑪...
  • Page 7: Definition Of Symbols

    15° from the vertical Symbol indicating the position "On" Symbol indicating the position "Off" of the switch on PolyLink effort / of the switch on PolyLink effort / position kit position kit Symbol indicating the charge state...
  • Page 8: Installation

    1. Attach the support to the Thorax effort belt. 2. With a thin tip like that of a pen, turn on the PolyLink effort/position kit by setting the switch to On (sliding door to left) and check that the LED is lit in green, indicating that the internal battery is charged.
  • Page 9: Recharging The Internal Battery Of The Kit

    PolyLink module for S.Box. Electromagnetic disturbances may temporarily interrupt the transmission of data without danger for the user. The internal battery for the PolyLink effort/position kit is recharged by the USB charger. In this ...
  • Page 10: Status Menu

    This menu is available from the firmware version 1.7 of the S.Box device. It is accessible when the S.Box device is in operation and when a PolyLink system or a pulse oximeter WristOx2 has been installed and paired. The information can be viewed successively but cannot be modified.
  • Page 11 POS: ( sensor inverted) POS: _ _ _. If POS: _ _ _ is displayed, check that the PolyLink system is installed correctly and that the PolyLink effort/position kit is turned on. Status of the internal battery for the PolyLink ❻...
  • Page 12: Real-Time Acquisition

    SEFAM Analyze software. Stopping treatment 1. With a thin tip like that of a pen, turn off the PolyLink effort/position kit by setting the switch to OFF (sliding door to left) and check that the LED is off.
  • Page 13: Removing The Polylink Kit

    In addition, if the S.Box is equipped with a humidifier, unlock the heater plate by pushing the  latch to the right and remove it. 3. Lift the lever of the PolyLink module and pull the module out of the accessory location of the device. 4. Re-place the side cover or the humidifier into the device: ...
  • Page 14: Trouble-Shooting

    S.Box device is working. If the problem persists, contact your Health Professional. Communication The PolyLink module is Check that the PolyLink module is paired in the impossible with the not paired with the settings menu of the S.Box device. See PolyLink kit.
  • Page 15: Technical Characteristics

    Technical characteristics Performance of the PolyLink kit Expected lifetime: 5 years Radio specifications RF emission type: Bluetooth Smart (BLE 4.1) Frequency band: 2402 to 2480 MHz (ISM band) Maximum power: 5.3 dBm Conditions of use Pressure range: 700 hPa to 1060 hPa Temperature: +5°C to +40°C...
  • Page 16: Physical Features

    Risks concerning this medical device are evaluated according to the ISO 14971 standard, specifically with regard to global residual risk. The PolyLink kit used with S.Box complies with the following directives and standards:  Directive 93/42/EEC of the Council concerning medical devices, modified by the European Directive 2007/47/EC.
  • Page 17: Essential Performances Requirements For Electromagnetic Compatibility

    Essential performances requirements for electromagnetic compatibility The essential performance is defined as follows: the position of the PolyLink Efforts / Position kit and the two signals from the thoracic and abdominal belts are correctly and safely transmitted to the PolyLink Module for S.Box.
  • Page 18 18  Technical characteristics PolyLink kit...
  • Page 20 Contact of your Health Professional Manufacturer: Manufacturing plant: SEFAM SEFAM 144 AV CHARLES DE GAULLE 10 ALLEE PELLETIER DOISY 92200 NEUILLY SUR SEINE 54600 VILLERS-LES-NANCY FRANCE FRANCE : M-167DFU00-10-Version 2 2018-12...

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