Genadyne XLR8 Manual

Genadyne XLR8 Manual

Negative pressure woun therapy

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XLR
 
 
 
Neg
gative Pr
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
R8
ressure W W ound T T herapy

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Summary of Contents for Genadyne XLR8

  • Page 1             gative Pr ressure W W ound T T herapy                                          ...
  • Page 2: Table Of Contents

      KEYPAD FEATURE ........................ 12   OPERATING THE DEVICE  ...................... 13       ......................................  1 3 TARTING  THERAPY MODE ......................... 13     ....................................  1 5 HERAPY  ELECTION ADJUSTING THE PRESSURE  ...................... 16   ALARMS  ............................ 16      ....................................  1 7 NABLE    ISABLE Genadyne Biotechnologies | EN (V 5.0909.1)  2   ...
  • Page 3   TECHNICAL SPECIFICATIONS ...................... 27   CONTACT INFORMATION ...................... 28   ADVANCE FEATURE (REMOVABLE) .................... 29      ....................................  2 9 OCK    NLOCK  EYPAD    ....................................  2 9 LARM  OG  LEARING   )  ........................  3 0 REATMENT  IME  ESET  OTH  ONTINUOUS AND  NTERMITTENT       Genadyne Biotechnologies | EN (V 5.0909.1)  3   ...
  • Page 4: Warnings

    This system has been designed to comply with the regulatory safety standards including UL 60601-1, CAN/CSA C22.2 No. 601.1-M90, CE 93/42/EEC Class IIa. This system is internally powered with battery and externally powered with an approved Class II power adapter.     Genadyne Biotechnologies | EN (V 5.0909.1)  4   ...
  • Page 5 mbols      Equipment t Classifica ation ngle use on Isolation typ pe BF appli ied part Date of Ma nufacture ace of Man ufacture Storage Te mperature ohazard Keep Dry ot for gener ral waste Serial Num aution: ee instructio ons for use Lot Numbe oduct Refe...
  • Page 6: Indication For Use

    Indication for use  The Genadyne XLR8 Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
  • Page 7: Patient Size And Weight

    Genadyne XLR8 Therapy to help minimize sensory stimulation and seek immediate medical assistance. Bradycardia     To minimize the risk of bradycardia, the Genadyne XLR8 Therapy dressing must not be placed in proximity to the vagus nerve.   Enteric Fistulas  ...
  • Page 8: Circumferential Dressing Application

      Physician Orders  Prior to placement of the Genadyne XLR8, the medical professional treating the wound must assess how to best use the system for an individual wound. It is important to carefully assess the wound and patient to ensure clinical indications for Negative Pressure Wound Therapy (NPWT) are met.
  • Page 9 Genadyne e XLR8 Neg gative Pres ssure Woun nd Therapy y (NPWT) s system. Use this manual as s a persona al reference...
  • Page 10: System Usage

    XLR8 mus st be used a a t these sug ggested ori ientations Gena adyne Biotech hnologies | EN (V 5.0909.1 1 )  10   ...
  • Page 11: Power Adapters

    Power Adapters  IEC-320 C8 Power Cord (Model# MPU30B-5) 19 VDC 1.57A 30W Canisters  200 CC Canister  400 CC Canister Genadyne Biotechnologies | EN (V 5.0909.1)  11   ...
  • Page 12 cessories  Y connecto or for multip ple wounds Carrying b ypad Feat ture    Power Butt Turns the de evice on an nd off.   Up Button ncrease suc ction press ure. Enable user r to scroll up p in a menu  ...
  • Page 13: Operating The Device

    Press the Power Button once. The LCD will be lighted up. The pump will start running. Suction is immediately available. Therapy Mode  The Genadyne XLR8 provides the user with 2 therapy mode. 1. Continuous 2. Intermittent If a symbol is observed on the top left corner of the screen, this means continuous therapy is active.
  • Page 14 The whole process will then cycle down and up until the treatment time finishes. 5. Down Pressure. Down pressure allows the user to determine the low vacuum threshold while the patient is on intermittent therapy. Up Time  Up Pressure  Down  Pressure  Down Time  Treatment  Time Genadyne Biotechnologies | EN (V 5.0909.1)  14   ...
  • Page 15: Therapy Selection

    6. To exit the intermittent setting screen and return to the main screen, hold on to the Exit / Cancel button for 5 seconds. The user can also press the Exit / Cancel button 3 times or more to exit to the main screen.     Genadyne Biotechnologies | EN (V 5.0909.1)  15   ...
  • Page 16: Adjusting The Pressure

    3 ala arm notifica ations in the e XLR8. Target T Timeout (Le eakage) Whenever there is a l eak in the d dressing or r the caniste...
  • Page 17: Enable / Disable

    Enable / Disable  The XLR8 provides the option for the user to enable or disable which alarm notifications they want to have turned on. To Enable / Disable the Alarm 1. Press Menu/Select button, use the Up/Down button to navigate to Alarm Setup, press the Menu/Select button again to enter into the Alarm Setup function.
  • Page 18: Target Timeout

    Use the Up/Down button to increase or decrease the desired time limit and press the Menu/Select button to confirm setting. Alarm Log  All alarms are logged and saved in the XLR8 memory. To enter into the alarm log 1. Press Menu/Select button 2.
  • Page 19: Preferences

    vance Men nu  The advanc ce menu is s for system m setups an nd therefor re untrained d users sho ould not be navigating i nto this par rt of the sys stem unless s being aut horized to d do so.
  • Page 20: System Info

    This function allows the user to choose which language to use. To select the desired language, navigate using the Up/Down button in the Language and press the Menu/Select button. The words in system will then automatically change to the selected language. Genadyne Biotechnologies | EN (V 5.0909.1)  20   ...
  • Page 21 XLR8 can run on both h battery po owered and d / or while plugged in with the po ower adapte ONLY US SE THE PO OWER ADA APTER THA AT CAME I IN THE BO OX. DO NOT...
  • Page 22 XLR8. Use mped cloth to clean th he pump. B Be cautious s when cle aning beca ause no liq quids shoul d enter the wer unit.
  • Page 23: Electromagnetic Compatibility

    Guidance and manufacturer’s declaration – electromagnetic emissions The Genadyne XLR8 is intended for use in the electromagnetic environment specified below.   The customer or the user of the Genadyne XLR8 should assure that it is used in such an   environment.
  • Page 24     THE Genadyne XLR8 is intended for use in the electromagnetic environment specified below. The customer or the user  of the Genadyne XLR8 should assure that it is used in such an environment.  Immunity test  IEC 60601  Compliance  Electromagnetic  Test level  level  environment – guidance  Electrostatic discharge  +/‐ 6 kV contact  Passed  Floors should be wood,  (ESD)    concrete or ceramic tile. If    +/‐ 8 kV air  floors are covered with  IEC 61000‐4‐2  synthetic material, the  relative humidity should be  at least 30%.  Electrical fast transient  +/‐ 2 kV for power supply  Below  Mains power quality should  / burst  lines  Maximum  be that of a typical    +/‐ 1 kV for input / output  permissible  commercial or hospital  IEC 61000‐4‐4  lines  limit ...
  • Page 25   The  Genadyne  XLR8  is  intended  for  use  in  an  electromagnetic  environment  in  which  radiated  RF  disturbances  are  controlled.  The  customer  or  the  user  of  the  Genadyne  XLR8  can  help  prevent  electromagnetic  interference  by  maintaining  a  minimum  distance  between  portable  and  mobile  RF  communications  equipment  (transmitters)  and  the ...
  • Page 26: Limited Warranty

      Genadyne Biotechnologies warrants its products, as listed below for one year on the machine. This warranty does not cover damage or breakdown to Genadyne units due to misuse or improper handling. The company will repair the system outside of the warranty coverage and shall bill the customer for parts and labor.
  • Page 27: Technical Specifications

    : 10% to 95% STORAGE AND SHIPPING CONDITIONS Ambient Temperature : 0°F to 110°F, -18°C to 43°C Relative Humidity : 10% to 95 % PATIENT PROTECTION Type BF COMPLIANCE UL 60601-1 IEC 60601-1 IEC 60601-1-2 CAN/CSA C22.2 No. 601.1   Genadyne Biotechnologies | EN (V 5.0909.1)  27   ...
  • Page 28: Contact Information

    Contact Information    Genadyne Biotechnologies Genadyne Canada Genadyne Europe Obelis S.A.  EU Representative  65 Watermill Lane 5675 Timberlea Blvd Zuiveringweg 94 Av.de Tervuren, bte44.  Great Neck, NY 11021  Mississauga, ON L4W 2S4  NL8243 PE Lelystad  1040 Brussels  USA  CANADA  THE NETHERLANDS  BELGIUM             1.800.208.2025 (Toll Free)  1.888.787.2811 (Toll Free)  +31.36.522.1744 (Tel)  +32 (0) 2.732.59.54 (Tel)  1.516.487.8787 (Tel)  1.877.487.7878 (Fax)  +31.36.522.6665 (Fax)  +32 (0) 2.732.60.03 (Fax)  1.516.487.7878 (Fax)                 www.genadyne.com www.genadyne.ca www.genadyne.eu  ...
  • Page 29 vance Fea ature (Rem movable) )  Lock k / Unlock k Keypad  To lo ock the keyp 1. Press and d hold the (loc ck / unlock) button + (exit t / cancel) bu utton for app proximately 7 second 2. When the icon change es to , the keyp pad is locked...
  • Page 30 atment Ti ime Reset  (Both Con ntinuous a and Interm mittent)  To re eset the treat tment time, t the user nee ds to go to th he main scre een. 1. Press and d hold (menu / select) but tton. 2. Press and d release in s sequence, th (on / off) bu utton, and th...

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