User Manual in PDF
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1. 13 DOIN TIN IOUS MIODE A E A A A E E AE 13 INTERMITTENT MOD E EEE E a E 14 THERAPY SELECTION ETMNIMTE 15 ADJUSTING THE PRESSURE 16 Genadyne Biotechnologies EN V 6 0511 1 C 16 ENABLE 17 TARET HME 18 19 ADVANCE 20 25 ETT TT 20 Sect Msn Oe n A E 21 21 BATTERY POWER 22 MAINTENANCE 23 GHI CK 23 RETURNING THE DEVICE 23 ELECTROMAGNETIC 1 2 nnnm 24 ELECTROMAGNETIC COMPATIBILITY NT EE m 25 ELECTROMAGNETIC COMPATIBILITY Tm2. me 26 LIVITED WARRANTY 27 TECHNICAL SPECIFICATIONS 28 CONTACT INFORMATION 29 ADVANCE FEATURES 30 Were da 2 0 000 2 1 10100000 M 30 ALARM LOG CLEARING 30 TREATMENT TIME RESET BOTH CONTINUOUS AND INTERMITTENT 0ssccccccessecccccesecccceeesecccceeeeeccseeeeecceseeeeccssseenecseseeuseceeseueneesessueneeesssagseeeeees 31 Genadyne Biotechnologies EN V 6 0511 1 XN Warnings DO NOT OPERATE THIS EQUIPMENT WITHOUT FIRST READING AND UNDERSTANDING THIS MANUAL IF YOU ARE UNABLE TO UNDERSTAND THE WARNINGS CAUTIONS AND INSTRUCTIONS CONTACT A HEALTHCARE PROFESSIONAL DEALER OR TECHNICAL PERSONNEL IF APPLICABLE BEFORE ATTEMPTING TO USE THIS EQUIPMENT OTHERWISE INJURY OR DAMAGE MAY RESULT BEFORE PERFORMING ANY MAINTENANCE TO THE CONSOLE DISCONNECT THE POWER CORD FROM THE WALL OUTLET REFER SERVICING TO QUALIFIED PERSONNEL ONLY GROUNDING RELIABILITY DEPENDS UPON A PROPERLY GROUNDED WALL OUTLET DO NOT USE THE POWER UNIT IN THE PRESENCE OF FLAMMABLE GASES SUCH AS
3. ANESTHETIC AGENTS WARNING CAUTION NOTICES USED IN THIS MANUAL APPLY TO HAZARDS OR UNSAFE PRACTICES WHICH COULD RESULT IN PERSONAL INJURY OR PROPERTY DAMAGE PLEASE MAKE SURE THAT THE POWER ADAPTER IS PLUGGED INTO THE WALL BEFORE PLUGGING INTO THE UNIT FAILURE TO FOLLOW THIS PRECAUTION MIGHT CAUSES DAMAGE TO THE UNIT Safety Standards This system has been designed to comply with the regulatory safety standards including UL 60601 1 CAN CSA 22 2 No 601 1 M90 CE 93 42 EEC Class Ila This system is internally powered with battery and externally powered with an approved Class power adapter Genadyne Biotechnologies EN V 6 0511 1 DES Equipment Classification Isolation type BF applied part Date of Manufacture Storage Temperature Keep Dry Serial Number Lot Number Authorized European Representative CSA International Classification Recognized Component Mark for Canada and the United States Power adapter 8 ud CN DEA oingle use only Place of Manufacture Biohazard EU Not for general waste Caution See instructions for use Product Reference Number CE Mark Double insulated Certified Body Power adapter Genadyne Biotechnologies EN V 6 0511 1 LES 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 re
4. 1 Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 60601 Test level 4 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth 5 Ut gt 95 96 dip in Ut for 0 5 cycle 4096 Ut 6096 dip in Ut for 5 cycles 7096 Ut 3096 dip in Ut for 25 cycles 596 Ut gt 95 dip in Ut for 5 sec Power frequency 50 60 3 A m Hz magnetic field IEC 61000 4 8 of the Genadyne XLR8 should assure that it is used in such an environment Compliance level Passed Below Maximum permissible limit Acceptable Performance Acceptable Performance Non Applicable Note Ut is the a c mains voltage prior to application of the test level The Genadyne XLRS8 is intended for use in the electromagnetic environment specified below The customer or the user Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mai
5. DA THE NETHERLANDS BELGIUM 1 888 787 2811 Toll Free 31 36 522 1744 Tel 32 0 2 732 59 54 Tel 1 877 487 7878 Fax 31 36 522 6665 Fax 32 0 2 732 60 03 Fax www genadyne ca www genadyne eu www obelis net GENADYNE 5 Distributed by Genadyne Biotechnologies EN V 6 0511 1 Advance Features Lock Unlock Keypad To lock the keypad 1 Press and hold the menu select button press a sequence of buttons down and v lock unlock then release 2 When the 3 Tounlock the keypad repeat step 1 above Up menu select icon changes to 4 The icon will then change from Alarm Log Clearing To clear the alarm log the user needs to go to the main screen Genadyne Biotechnologies Inc 1 Press and hold button menu select Treatment Time Sh 00m 2 Press the lock unlock and release while holding onto number 1 mmHg 3 Press while holding onto number 1 exit cancel and release Negative Pressure Wound Therapy 09 58 24 February 24 2009 4 Release the 7 menu select button Genadyne Biotechnologies EN V 6 0511 1 ETE Treatment Time Reset Both Continuous and Intermittent To reset the treatment time the user needs to go to the main screen 1 Press and hold f menu select button 2 Press and release in sequence the on off button and the lock unlock button 3 Release the 7 menu s
6. SE AN UNKNOWN POWER ADAPTER Battery life is between 2 to 25 Battery life is between 25 to 50 Battery life is between 50 to 75 Battery life is between 75 to 100 Battery life is between 0 to 2 Alarm notification will occur user needs to plug in the power adapter to recharge the battery Battery is charging Battery is fully charged and system is running on while the power adapter is plugged in Genadyne Biotechnologies EN V 6 0511 1 Maintenance There are no serviceable parts in the device Do not attempt to open the enclosure Contact your distributor if service is required Before each usage inspect the device for visible signs of damage Please contact your distributor if visible signs of abuse and damage have been observed Cleaning Adherence to facility directives concerning hygiene is of prime importance Only use low level diluted form of disinfectants or cleaning agents when cleaning the XLR8 Use damped cloth to clean the pump Be cautious when cleaning because no liquids should enter the power unit If the liquid goes inside of the power unit it might cause the unit to malfunction or damage the mechanics Dry with a separate soft cloth Do not use solvents or abrasives gt gt Do not immerse any part of the XLR8 in fluid or use an unnecessarily wet cloth Please contact your distributor if any liquids penetrated the device Returning the device For any returns or renta
7. XLR8 Negative Pressure Wound Therapy GENADYNE TABLE OF CONTENTS 11115454 O AAE EIEEE A EE EEEE EITE 4 SAFET STANDARD eea E EE E E EES 4 5 INDICATION FOR 48 6 CONTRAINBIEATIONS 6 PRECAUTION 6 SIANDABRDIPREUCAUTIONS 6 CONTINUOUS VERSUS INTERMITTENT THERAPY cccsccsccecccsccscceccscceseeseuseuceesceceesseeseuseuseeceecceesesseuseeseceescesseesesseuseceeccecseeeesseuseuceeseuceeesenees 6 5 7 SPINAL 7 2 CAR OIA 2 2120 00 TETTE 7 ENTERIC I TULA 22 22 0 2 et MM LM 7 PROTECT PERIW OUND SKIN tcm o 7 CIRCUMFERENTIAL DRESSING 8 ORDER TEETH 9 INTRODUCTION 9 FRG CIR 9 RT 10 uelis M Bi zT RE 11 CANISTER c 11 ACCE SORES d 12 14 54 51 FEATURE 12 OPERATING 442 13 8 9 13 THERAPY MODE
8. e pump will start running Suction is immediately available Therapy Modes The Genadyne XLR8 provides the user with 2 therapy mode 1 Continuous 2 Intermittent Continuous Mode Ifa symbol C observed on the top left corner of the screen this means continuous therapy is active The system sets it at continuous therapy mode by default If the symbol is observed this means intermittent therapy is in active Genadyne Biotechnologies Inc Genadyne Biotechnologies Inc Treatment Time Sh 00m Treatment Time 7h 00m Up Time 7m Down Time 5m mmHg mmHg 9 0 1 LRE KLRE Negative Pressure Wound Therapy Negative Pressure Wound Therapy 09 58 24 f 09 58 24 February 24 2009 February 24 2009 Continuous Mode Intermittent Mode Genadyne Biotechnologies EN V 6 0511 1 EE Intermittent Mode In intermittent mode the high pressure time Up Time and low pressure time Down Time will also be displayed on the main screen The user will be asked to set 5 parameters when selecting intermittent 1 Treatment time Treatment time allows the user to set how long they want the patient to be on intermittent therapy mode Once the treatment time ended the system will automatically switch back to continuous therapy mode 2 Up Time Up time allows the user to determine how long they want the system to hold at a set high pressure vacuum When the time is up it will go down to the set down pressure and will r
9. eatment Time 192h 31m mmHg XLR8 Negative Pressure Mound Therapy Actual Pressure Keypad Lock Unlock m On OFF Button Lock Unlock Button Power Jack Inlet Suction Strength System Status Date amp Time Menu Select Exit Cancel Up Button Down Button Genadyne Biotechnologies EN V 6 0511 1 ETE System Usage The XLR8 must be used ONLY at these suggested orientations YES NO NO Genadyne Biotechnologies EN V 6 0511 1 Power Adapters IEC 320 C8 Power Cord Model 5 19 VDC 1 57A 30W Canisters Available Canisters 200 cc Canisters 400 cc Canisters 600 cc Canisters 800 cc Canisters Genadyne Biotechnologies EN V 6 0511 1 PE Accessories connector for multiple wounds Carrying bag Keypad Feature Power Button Turns the device on and off Up Button Increase suction pressure Enable user to scroll up in a menu Down Button Decrease suction pressure Enable user to scroll down in a menu Lock Unlock Lock and unlock keypad Menu Select Brings up the system menu Enable user to select the desired function Exit Cancel Exit from the system menu Enable user to cancel from current and selected function Genadyne Biotechnologies EN V 6 0511 1 Operating the device Starting Up Press the Power Button a once The LCD will be lighted up Th
10. elect button 4 The treatment time will be reset to 00 00 00 Genadyne Biotechnologies EN V 6 0511 1
11. emain at that level until the down time ends The whole process will then cycle up and down until the treatment time finishes 3 Up Pressure Up pressure allows the user to determine the high vacuum threshold while the patient is on intermittent therapy 4 Down Time Down time allows the user to determine how long they want the system to hold at a set low pressure vacuum When the time is up it will go up to the set up pressure and will remain at that level until the up time ends 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 Intermittent Therapy Up Pressure mmHg Down Pressure Time Genadyne Biotechnologies EN V 6 0511 1 Therapy Selection To select which therapy to use at anytime 1 Press the Menu Select button 2 Scroll using the Up button or Down button and choose the Treatment Mode function by pressing the Menu Select button once 3 Choose either Continuous or Intermittent by pressing the Menu Select button once 4 For Continuous selection after Step 3 exit to the main screen by holding on to the Exit Cancel button for 5 seconds The user can also press the Exit Cancel button 2 times or more to exit to the main screen 5 For Intermittent selection after Step 3 press Menu Select button one more time to enter into the i
12. he Up button or Down button to increase or decrease the desired vacuum pressure All settings are in mmHg Once the vacuum pressure Is set press the Menu Select button to confirm selection It will then bring you back to the Intermittent setting screen 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 6 0511 1 15 Adjusting the pressure At any given point in time except when the keypad is locked whether the system is On or Off whether it is on a therapy or not the user can adjust the pressure by pressing the Up button to increase the vacuum pressure or the Down button to decrease the down pressure Alarms There are 4 alarm notifications in the XLR8 Target Timeout Leakage Whenever there is a leak in the dressing or the canister the Target Timeout alarm will occur Low Battery Whenever the battery level is less than 2 which typically it will have less than 30 minutes of operating time the low battery alarm will occur Blockage Blockage alarm occurs when there is a blockage in between wound dressing and the canister Canister Full Canister Full alarm occurs when the canister is filled with exudates Genadyne Biotechnologies EN V 6 0511 1 160 Genadyne Biotechnologies Inc Treatment Time 5h 00m Nega
13. inuous piece to minimize the risk of decreased distal circulation Extreme care should be taken not to stretch or pull the film when securing but let it attach loosely and stabilize edges with an elastic wrap if necessary When using circumferential film techniques it is crucial to systematically and recurrently palpate distal pulses and assess distal circulatory status If circulatory compromise is suspected discontinue therapy remove dressing and contact a physician 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 All orders should include Wound location size and type Dressing kit type Vacuum settings Frequency of dressing changes Adjunctive dressings Genadyne Biotechnologies EN V 6 0511 1 ES Introduction Information provided in this user manual contains important information regarding the safe and effective operation of the Genadyne XLR8 Negative Pressure Wound Therapy NPWT system Use this manual as a personal reference and also in the training of personnel Preventive maintenance cleaning and disposal information are also included Features Therapy Mode Continuous or Intermittent Battery Indicator USB Plug Target Pressure r
14. l returns prior to returning the device to your representative the device must be cleaned in line with the steps laid out under the cleaning section of this manual All used canisters have to be disposed ai Disposal of used canisters should follow facility protocols or local ordinances relating DG to the handling of potentially infected or bio hazardous materials The device will also need to be returned in the original packaging Genadyne Biotechnologies EN V 6 0511 1 Pa 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 Emission Test Compliance Electromagnetic environment guidance RF emissions Group 1 The Genadyne XLR8 uses RF energy only for its internal function Therefore its RF emissions are very low and CISPR 11 are not likely to cause any interference in nearby electronic equipment RF emissions Class B The Genadyne XLR8 is suitable for use in all establishments including domestic establishments and CISPR 11 those directly connected to the public low voltage power Harmonic emision Class A supply network that supplies buildings used for domestic purposes IEC 61000 3 2 Voltage fluctuations flicker emissions Complies IEC 61000 3 3 Genadyne Biotechnologies EN V 6 0511
15. moval of excess exudates infectious material and tissue debris Contraindications Genadyne XLR8 Therapy is contraindicated for patients with Malignancy in the wound Untreated osteomyelitis NOTE Refer to Clinical Guide for Osteomyelitis information Non enteric and unexplored fistulas Necrotic tissue with eschar present NOTE After debridement of necrotic tissue and complete removal of eschar Genadyne XLR8 Therapy may be used Oo O 0O CAUTION Do not place dressing directly in contact with Exposed blood vessels Anastomotic sites Organs Nerves NOTE Refer Clinical Guide for additional information concerning Bleeding Precautions Precautions should be taken for patients who are or may be receiving anticoagulant therapy suffering from difficult hemostasis untreated for malnutrition and non compliant or combative Standard Precautions To reduce the risk of transmission of blood borne pathogens apply standard precautions for infection control with all patients per institutional protocol regardless of their diagnosis or presumed infection status In addition to gloves use gown and goggles if exposure to body fluid is likely Continuous versus Intermittent Therapy Continuous rather than intermittent Genadyne XLR8 Therapy is recommended over unstable structures such as an unstable chest wall or non intact fascia in order to help minimize movement and stabilize the wound bed Continuous the
16. ns power quality should be that of a typical commercial or hospital environment If the user of the Genadyne XLR8 be powered from an uninterruptable power supply or a battery Power frequency magnetic fields should be at levels characteristics of a typical location in a typical commercial or hospital environment Genadyne Biotechnologies EN V 6 0511 1 ram Genadyne XLRS8 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 test level Compliance level Conducted RF 3 Vrms 3V IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz Interference may occur in the vicinity of equipment marked with the following symbol 4 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The 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 XLR8 as recommended below according to the maximum ou
17. ntermittent setting screen a Treatment Time Press the Menu Select button to enter the desired treatment time Use the Up button or Down button to increase or decrease the desired time All settings are in hours Once the treatment time is set press the Menu Select button again to confirm selection It will then bring you back to the Intermittent setting screen b Up Time Press the Menu Select button to enter the desired up time Use the Up button or Down button to increase or decrease the desired time All settings are in minutes Once the up time 15 set press the Menu Select button again to confirm selection It will then bring you back to the Intermittent setting screen c Up Pressure Press the Menu Select button to enter the desired high pressure threshold Use the Up button or Down button to increase or decrease the desired vacuum pressure All settings are in mmHg Once the vacuum pressure Is set press the Menu Select button to confirm selection It will then bring you back to the Intermittent setting screen d Down Time Press the Menu Select button to enter the desired down time Use the Up button or Down button to increase or decrease the desired time All settings are in minutes Once the down time is set press the Menu Select button to confirm selection It will then bring you back to the Intermittent setting screen e Down Pressure Press the Menu Select button to enter the desired low pressure threshold Use t
18. rapy is also generally recommended for patients at Genadyne Biotechnologies EN V 6 0511 1 mm increased risk of bleeding highly exudating wounds fresh flaps and grafts and wounds with acute enteric fistulae Patient Size and Weight The size and weight of the patient should be considered when prescribing Genadyne XLR8 Therapy Infants children certain small adults and elderly patients should be closely monitored for fluid loss and dehydration Also patients with highly exudating wounds or large wounds in relation to the patient size and weight should be closely monitored as they may have a risk of excessive fluid loss and dehydration When monitoring fluid output consider the volume of fluid in both the tubing and canister Spinal Cord Injury In the event a patient experiences autonomic hyperreflexia sudden elevation in blood pressure or heart rate in response to stimulation of the sympathetic nervous system discontinue 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 Wounds with enteric fistulas require special precautions to optimize Genadyne XLR8 Therapy In certain circumstances the Genadyne XLR8 Therapy may help to promote healing in wounds with an enteric fistula When the physician orders the Genadyne XLR8 Therapy i
19. t is recommended that support from an expert clinician is sought Genadyne XLR8 Therapy is not recommended or designed for fistula effluent management or containment but as an aid to wound healing Genadyne XLR8 Therapy is not recommended if enteric fistula effluent management or containment is the sole goal of this therapy Protect Periwound Skin Consider use of a skin preparation product to protect periwound skin Do not allow wound filler to overlap onto intact skin Protect fragile friable periwound skin with additional hydrocolloid or other transparent film e Multiple layers of the transparent film dressing may decrease the moisture vapor transmission rate which may increase the risk of maceration e f any signs of irritation or sensitivity to the film dressing wound filler or tubing assembly appear discontinue use and consult a physician avoid trauma to the periwound skin do not pull or stretch the transparent film over the wound filler dressing during film application e Extra caution should be used for patients with neuropathic etiologies or circulatory compromise Genadyne Biotechnologies EN V 6 0511 1 Circumferential Dressing Application Avoid use of circumferential dressings except in the presence of anasarca or excessively weeping extremities where a circumferential film technique may be necessary to establish and maintain a seal Consider using multiple small pieces of transparent film rather than one cont
20. timeout function is to enable the user to determine how soon after should the device start alarming to notify the user of a leakage event occurring For example if the target timeout is set at 30 seconds this means that in the event of a target timeout it will have to last for at least 30 seconds continuously before the system starts alarming Use the Up Down button to increase or decrease the desired time limit and press the Menu Select button to confirm setting Genadyne Biotechnologies EN V 6 0511 1 EN Alarm Log All alarms are logged and saved in the XLR8 memory To enter into the alarm log 1 Press Menu Select button 2 Navigate to Alarm Setup by using the Up Down button and press the Menu Select button to enter into the Alarm Setup function 3 Navigate to the Alarm Log by using the Up Down button and press the Menu Select button to enter into the Alarm Log screen 4 All the past alarms will be shown on the screen 5 To acknowledged them scroll to the desired alarm notification and press the Menu Select button 6 The alarm bell will stop once acknowledged 7 The asterisk on the left side of the notification WILL NOT disappear until the problem is fixed To exit to the main screen press and hold on to the Exit Cancel button for 5 seconds Genadyne Biotechnologies EN V 6 0511 1 rmm Advance Menu The advance menu is for system setups and therefore untrained users should not be navigating into this part of the s
21. tive Pressure Wound Therapy 09 58 24 User needs to refer to February 24 2009 Alarm Log verify the problem The alarm bell will not stop until the user acknowledges the notification by pressing the Menu Select button when the alarm log screen is up In the event when the alarm screen is not present please follow the instructions on how to find the alarm log in this manual 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 2 Press Menu Select button to select the Enable Disable function 3 Genadyne Biotechnologies EN V 6 0511 1 Genadyne Biotechnologies Inc Target Timeout Low Battery Blockage Canister Full Arrows on the side means enabled To select the desired alarm navigate to the desired alarm and press the Menu Select button once The arrow will appear on the 135 55 side Genadyne Biotechnologies Inc wir Target Timeout Low Battery Blockage Canister Full Disabled No arrows To disable the alarms navigate to the desired alarm and press Menu Select once to have the arrow disappear 6 057 4 o exit to the main screen press and hold the Exit Cancel button for 5 seconds Target Timeout The target
22. tput power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter m power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 69 3 69 m 7 38 100 11 67 11 67 23 33 Genadyne Biotechnologies EN V 6 0511 1 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 ltems sent in for repair outside of warranty period that are paid shall have a limited 90 day warranty commencing from the date the product is shipped back to the customer ltems sent in that are covered under the warranty period shall not have their warranty extended other than having the time remaining on the warranty continue once the repaired product is shipped back to the customer The company also reserves the right to revise the warranty policy from time to time and to issue different warranty policies for different products This warranty shall supersede and replace all warranties of merchantability and fitness applicable to the fullest extent allowed under the laws of State of New York Warranted Produc
23. ts Genadyne A4 Negative Pressure Wound Therapy System Genadyne XLR8 Negative Pressure Wound Therapy System Genadyne Biotechnologies EN V 6 0511 1 ES Technical Specifications VACUUM PUMP Service Life est Unlimited Brushless motor Minimum Vacuum 50mmHg Maximum Vacuum 220mmHg Suction capacity 4 Liters per Minute DIMENSIONS WEIGHT Dimension 5 9 L x 3 9 W x 2 1 H 150 mm 99 mm x 53 mm Weight 1 5 lbs 0 68 kg ELECTRICAL REQUIREMENT Power 19 VDC 1 58A 30W Min 20 VDC Max Model MPUSOB 5 Battery Type Li lon rechargeable batteries Recharge Time 3 Hours Safety EN55011 Class B UL cUL 60601 1 TUV GS 60601 1 CE Mark LVD ENVIRONMENTAL CONDITIONS Operating Conditions 18 C to 34 C 65 F to 94 F Relative Humidity 1096 to 95 STORAGE AND SHIPPING CONDITIONS Ambient Temperature O F to 110 18 C to 43 Relative Humidity 1096 to 95 96 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 6 0511 1 Contact Information Genadyne Biotechnologies 16 Midland Ave Hicksville NY 11801 USA Toll Free 1 800 208 2025 Tel 1 516 487 8787 Fax 1 516 487 7878 www genadyne com Genadyne Canada Genadyne Europe Obelis S A EU Representative 31 Tamara Pl Unit 1 Zuiveringweg 94 Bd General Wahis 53 Brantford N3P 1 8 NL8243 PE Lelystad 1030 Brussels CANA
24. ystem unless being authorized to do so Preferences In preferences there are 2 functions for user to choose from Time This function will enable the user to change the time accordingly to the local time To set the time go to 1 Menu gt Advance Menu gt Preference gt Time 2 Use the MM and YYYY 3 Use the up button to increase the value and V down button to decrease the value menu select button to toggle between HH MM SS DD 4 After the correct time and date is entered press the button to store the vale lock unlock 5 Hit the exit cancel button to exit to the main screen Backlight This function allows the user to set the backlight to either brighter or dimmer according to the user s preference Genadyne Biotechnologies EN V 6 0511 1 20 System Info System info provides information about the system software version serial number and the usage meter is included in this function Language Selection 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 6 0511 1 Battery Power The XLR8 can run on both battery powered and or while plugged in with the power adapter ONLY USE THE POWER ADAPTER THAT CAME IN THE BOX DO NOT U
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