SEFAM PolyLink Procedure For Installation And Usage Download Page 4

 

 Before you start 

PolyLink kit 

Before you start 

 

Please  read  this  procedure  carefully  before  using  the  PolyLink  kit  so  that  you  fully  understand  the  operation 
limitations of this accessory.  

Safety guidelines 

WARNING: 

In this manual, it means that there is a risk of danger of injury or accident 
to yourself or others. 

 

The  PolyLink  kit  must  be  used  under  medical  supervision  for  the  recommended  use  indicated  in  this 
procedure. Follow the recommendations given by your physician. 

 

The PolyLink kit is an accessory of the S.Box device. So before installing it, read the safety guidelines and 
the instructions for installation indicated in the S.Box patient manual. In particular, place the S.Box device on 
a stable horizontal surface and in a clean and dry environment. 

 

The PolyLink kit must be used only with the S.Box Positive Pressure device. Make sure that you have the 
instructions for use for each item and read them carefully. 

 

The PolyLink kit is not intended to provide assistance for vital functions. 

 

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. 

 

Do not attempt to modify the elements of the PolyLink kit. The maintenance of this equipment is entirely the 
responsibility of a qualified person. Contact your Health Professional.  

 

Keep the PolyLink kit away from children and pets. 

 

The PolyLink kit complies with the electromagnetic compatibility regulation for medical devices. If you use 
any  critical  medical  device  such  as  a  pacemaker,  contact  your  physician  and  the  manufacturer  of  this 
device for more precautions. 

 

Do not use the PolyLink kit in locations containing flammable or explosive materials. 

CAUTION: 

In this manual, it means that there is the possibility of material damage to 
this unit or any other. 

 

Contact  your  Health  Professional  if  you  suspect  that  this  accessory  or  one  of  its  elements  is  defective, 
damaged or not working properly. 

 

In case of problem, the PolyLink kit must be sent back in its original packaging. 

 

Like  any  electrical  device,  the  PolyLink  kit  is  likely  to  be  disturbed  by  mobile  or  portable  radio  frequency 
communication devices (mobile phones, etc.). 

 

The Polylink kit is not suitable for a usage near HF electrosurgical equipment. 

 

To ensure the proper operation of the PolyLink kit against electromagnetic disturbances, the two parts of 
the PolyLink kit must not be opened. In case of default for closing a casing, contact the Health Professional 
who  provided  you  the  PolyLink  kit.  Not  respecting  the  requirements  of  use  may  result  in  a  performance 
degradation related to electromagnetic disturbances. 

Recommended use 

The PolyLink kit is an accessory of the S.Box CPAP device, intended to be used by patients suffering 
from sleep respiratory disorders and treated only by this device. It allows acquiring and transmitting 
to the S.Box device the signals of respiratory effort and body position via a wireless communication. 
It  can  be  used  at  home  or  in  care  center  and  allows  the  clinical  teams  to  monitor  the  treatment 
efficiency of the patient. There is no contra-indication or precaution of clinical use specific to usage of 
the PolyLink kit. 
The  Pulse  Oximeter  WristOx2  can  also  be  used  with  the  S.Box  device  to  complete  a  control 
Polygraphy. In this case, follow the recommendations of the manufacturer. 
 

Summary of Contents for PolyLink

Page 1: ......

Page 2: ...chnical locations SEFAM 144 AV CHARLES DE GAULLE 92200 NEUILLY SUR SEINE FRANCE SEFAM 10 ALLEE PELLETIER DOISY 54600 VILLERS LES NANCY FRANCE TEL 33 0 3 83 44 85 00 www Sefam medical com Technical assistance E mail technicalservice sefam medical com ...

Page 3: ...9 Communication with the PolyLink kit 9 Status menu 10 Real time acquisition 12 Stopping treatment 12 Transport of the PolyLink kit 12 Removing the PolyLink kit 13 Cleaning and Caring 13 Trouble shooting 14 Technical characteristics 15 Performance of the PolyLink kit 15 Radio specifications 15 Conditions of use 15 Transport and storing conditions 15 Electrical characteristics 15 Physical features ...

Page 4: ...ny critical medical device such as a pacemaker contact your physician and the manufacturer of this device for more precautions Do not use the PolyLink kit in locations containing flammable or explosive materials CAUTION In this manual it means that there is the possibility of material damage to this unit or any other Contact your Health Professional if you suspect that this accessory or one of its...

Page 5: ...is equipment and the other devices should be observed to verify that they are operating normally WARNING Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation WARNING RF portable communication d...

Page 6: ...the internal battery indicates the positions On right and Off left of the switch on the PolyLink effort position kit support in which the PolyLink effort position kit must be inserted It is used to position and maintain the effort sensor on the thorax belt and to store the surplus cables sliding door depending on its position you can either switch on switch off or charge the PolyLink effort positi...

Page 7: ...n Off of the switch on PolyLink effort position kit Symbol indicating the charge state of the internal battery of the PolyLink effort position kit USB connection Class II device Non ionizing radiation symbol Manufacturer Manufacturing date Reference of the PolyLink module for S Box Serial number Device in accordance with the requirements of the European directive 93 42 EC on medical devices Device...

Page 8: ...quipped with a humidifier reinsert the heater plate on the rails in the side part of the device and push it against the device Re lock the heater plate by pushing the latch to the left Install the base of the humidifier chamber on the heater plate and push the chamber against the device until you hear a click 5 Plug the S Box device into the power supply or electrical power grid Implementation of ...

Page 9: ...e patient s body position to the 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 configuration electromagnetic disturbances may temporarily interrupt the charge of the battery without danger for the user Communicatio...

Page 10: ...it used a new search is possible by tapping the key or 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 To access it tap the touch button when the S Box devi...

Page 11: ...ing on the importance of the thorax movements If THO _ _ _ is displayed check that PolyLink effort position kit is turned on that the thoracic effort sensor is connected and that its tension is correct Tap the touch button Status of the body position sensor Possible displays POS lying on back POS lying on stomach POS lying on right side POS lying on left side POS standing POS sensor inverted POS _...

Page 12: ... present CAUTION Make sure that the SD card is inserted in the S Box device for the real time acquisition Check that the symbol is present in the center of the display showing that the BLE wireless communication is enabled Do not unplug the S Box device Once the S Box comes back to standby the polygraphic control is complete the SD memory card can be removed from the S Box device The data saved on...

Page 13: ...er chamber on the heater plate and push the chamber against the device until you hear a click 5 Unplug the effort sensors from the PolyLink effort position kit 6 Refer to the user manuals to remove the effort sensors thorax and abdomen and their belts Cleaning and Caring As the PolyLink module is an accessory designed to be installed inside the S Box device it does not require any special maintena...

Page 14: ...em if necessary If the problem persists contact your Health Professional The LED of the effort position kit is off The extinction of the LED is automatic when the effort position kit has been working for 1 minute If the LED never lights up contact your Health Professional The symbol is not present in the center of the display when the S Box device is working The BLE Bluetooth Low Energy communicat...

Page 15: ... 0 2 500 m Transport and storing conditions Pressure range 700 hPa to 1060 hPa Temperature 25 C to 70 C Relative humidity between 5 and 93 without condensation Electrical characteristics PolyLink module for S Box Input voltage 5 Vdc 5 powered by the electrical connector of the S Box device Maximum power consumption 45 mW 9 mA PolyLink effort position kit Input voltage 5 Vdc 5 Maximum power consump...

Page 16: ... the following directives and standards Directive 93 42 EEC of the Council concerning medical devices modified by the European Directive 2007 47 EC Directive 2014 53 EU RED of the European Parliament and of the Council on the harmonization of the laws of the Member States relating to the making available on the market of Radio Equipment Directive 2006 66 EC of the European Parliament and of the Co...

Page 17: ... energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Harmonic emissions IEC 61000 3 2 Class A Voltage fluctuations Flicker emissions IEC 61000 3 3 Complies Equipment is tested in HOME HEALTHCARE ENVIRONMENT more severe than the PROFESSIONAL HEALTHCARE FACILITY ENVIRONMENT It can be connected to PU...

Page 18: ...18 Technical characteristics PolyLink kit ...

Page 19: ......

Page 20: ...r Manufacturing plant SEFAM 144 AV CHARLES DE GAULLE 92200 NEUILLY SUR SEINE FRANCE SEFAM 10 ALLEE PELLETIER DOISY 54600 VILLERS LES NANCY FRANCE M 167DFU00 10 Version 2 2018 12 Contact of your Health Professional ...

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