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...
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.
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 ...
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...
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 ...
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 ...
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 ...
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.
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.
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.
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.
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 ...
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.
: 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 ...
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...
Need help?
Do you have a question about the XLR8 and is the answer not in the manual?
Questions and answers