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SEFAM PolyLink, Процедура установки и использования

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PolyLink kit 

Description 

 5 

Description 

 

List of authorized accessories 

The PolyLink complete kit Ref. M-116700 is delivered in a box that includes the following items: 

 

Reference 

 

Reference 

PolyLink module for S.Box  

M-216730-00 

PolyLink effort/position kit  
with its support 

M-216730-02 
M-216730-03 

PolyLink effort sensor – Thorax 

1369 

PolyLink effort sensor – Abdomen 

1368 

2 belts for effort sensor 

1350 

PolyLink SD card 

M-315890-01 

USB charger of effort/position 
kit 

 
M-416710-00 

Power cord for USB charger 

 
M-216730-01 

PolyLink transport bag 

M-816705-00 

Procedure of Installation 

M-167DFU00-10 

 

WARNINGS: 

 

Use  only  the  authorized  accessories  given  in  the  list  above  or  compliant  with  the  standard  
EN ISO 17510-2:2007. 

 

WARNING: Use of this equipment adjacent to or stacked with other equipment should be avoided because it 
could result in improper operation. If such use is necessary, this 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 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. 

Overwiew of PolyLink elements 

PolyLink  module  for  S.Box:  intended  to  be  inserted  in  the  S.Box  device  that  powers  it.  It  allows 
retrieving the data of position and of respiratory efforts via a wireless communication. 

 

 

Figure 1 – Views of the PolyLink module for S.Box 

 

①

 

Electrical connector for plugging the PolyLink module into the S.Box device 

②

 

Plastic case of the module  

③

 

Lever to remove

 

the module from the S.Box device 

 

①

 

③

 

①

 

②

 

Содержание PolyLink

Страница 1: ......

Страница 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 ...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 _...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 18: ...18 Technical characteristics PolyLink kit ...

Страница 19: ......

Страница 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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