Genadyne XLR8 User Manual
Contents
1. X 28 TREATMENT TIME RESET BOTH CONTINUOUS AND VARIABLE eene 29 DRESSING 30 MAINTENANCE 3 ia aaa ua aaa 32 RER AA AA AI 33 DEPO T OOF TE DEVIC AA AAA 33 LIMITED WARRANTY iii 33 ELECTROMAGNETIC COMPATIBILITY ec nnnm 34 ELECTROMAGNETIC COMPATIBILI Y Ai 35 ELECIROMAGNETIC COMPATIBILITY 3 1 ine tenti niic tes rame i dtu 36 TECHNICAL 37 CONTACT INFORMA 38 Genadyne Biotechnologies DMR03 091 Rev J l8 Safety Standards Read All Instructions Prior To Use When using electrical devices especially when children are present basic safety precautions should always be followed including the following the risk of electrocution ALWAYS unplug this product immediately after using or when charging is completed DO NOT use while bathing DO NOT place or store product where it can fall or be pulled into a tub or sink DO NOT Place or drop into water or other liquid DO NOT reach for a product that has fallen into water Unplug immediately DANGER WARNING The use of external accessories and cables other than those pr2. MPUSOB 5 19 VDC 1 57A 30W Is Genadyne Biotechnologies DMR03 091 Rev J EXE Symbols GENADYNE XLR8 Wound Vacuum System REF A4 S0002 XLR8 NPWT System Label Reproduction 0444 Input 19 VDC 1 58 A E IPX1 BA a X Equipment Classification Isolation type BF applied part oingle use only Date of Manufacture Place of Manufacture y Storage Temperature T Keep Dry Serial Number Lot Number Authorized European Representative CSA International Classification Biohazard EU Not for general waste Caution Read instructions before use Product Reference Number a2 GLADE XLR8 Notified Body CE Mark T8 Double insulated Recognized Component Mark for Canada and the United States Power adapter TUVRheinland Certified Body Power adapter gt m Drip Proof or IPX1 rated Genadyne Biotechnologies DMRO03 091 Rev J l Indication for use The Genadyne KLR8 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 User The Genadyne XLR8 NPWT system is designed for use by licensed healthcare professionals only Patients may be trained to perform some limited functions but the keyboard is locked by the professional to prevent the patient from changing the settings
3. 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 590 Ut 295 dip in Ut for 0 5 cycle 40 Ut 6090 dip in Ut for 5 cycles 70 Ut 3096 dip in Ut for 25 cycles lt 5 Ut 295 dip in Ut for 5 sec 3 A m 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 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 30 Mains power quality should that of a typical commercial or hospital environment 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 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 DMR03 091 Rev J las The Genadyne XLRS is intended for use in electromagnetic environment specified below The customer user of Genadyne XLRS should assure that it is used in such an environment Immunity
4. XLR 8 Negative Pressure Wound Therapy TABLE OF CONTENTS SAFETY STANDARDS 1 eene n nmm nmm nnnm nennen eere ee see heise sese 4 5 6 INDICATION FOR USE eese nennen nennen nnn nnnm nennen 7 ji 7 CONTRAINDICATIONS eese Rn 7 PRECAUTIONS PE 8 STANDARD PRECAUTION 4 RR m 8 CONTINUOUS VERSUS VARIABLE THERAPY wa 8 PATENT KAN AA 9 e UPS S UEM DC IAA 9 DEAD ARD RKRRI 9 UE TA NIRE ue 9 OU Vy OID KU RR ONE 9 CIPCUMBERENTESUUDICESSINGOSAPPIUCUAEION 4 5 M E UE 9 OPERATING PRECAUTION 10 PHYSICIAN ORDERS 11 DRESSING CHANGES 11 CANISTER 6 11 INTRODUCTION E E EAEE E EEEE 12 FEATURED AAA 12 USAGE II 13 CANIDIER Ia 14 BRESSING SOLUTION S ETERS 14 ACCESSORIE AA 15 XI PR NI erae erra EEA E RE EEI AEE E A EE EEE ETER 15 OPERATING IHE DEVICE 16 STARTING UP POWERING DOWN 16 THERAPY WO DES T 16 WSS
5. Toll Free 1 516 487 8787 Tel 32 0 2 732 59 54 Tel 1 877 487 7878 Fax 1 888 570 7152 Fax 32 0 2 732 60 03 Fax www genadyne ca www genadyne com www obelis net GENADYNE 4 Distributed Genadyne Biotechnologies DMR03 091 Rev J
6. CANISTER FULL REPLACE CANISTER REMOVE CANISTER FROM UNIT REPLACE WITH A NEW CANISTER TURN UNIT OFF ONCE COMPLETELY OFF TURN BACK ON AND CONTINUE THERAPY Genadyne Biotechnologies DMR03 091 Rev J 20 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 Alert will occur The Message on the screen will show ALERT LOW BATTERY PLUG UNIT IN ELECTRICAL SOCKET TO CONTINUE THERAPY Blockage Blockage Alert occurs when there is a blockage in between wound dressing and the canister The Message screen will show ALERT BLOCKAGE REVIEW DRESSING AND TUBING MAKE SURE THAT CLAMPS ARE OPEN PRESS MENU BUTTON TO CONTINUE THE THERAPY Critical Battery Critical Battery Alert occurs when the battery level is less than 5 and will require the user to plug in the power adapter to charge the machine and use the machine NOTE MACHINE WILL NOT WORK UNTIL A POWER ADAPTER IS PLUG IN The Message on the screen will show ALERT CRITICAL BATTERY ONLY 5 6 OF CHARGE LEFT ON BATTERY PLUG UNIT IN ELECTRICAL SOCKET Genadyne Biotechnologies DMRO03 091 Rev J Biotechnologies Inc Treatment Time 5h 00m Negative Pressure Wound Therapy 09 58 24 User needs to inspect February 24 2009 N dressings and unit An unverified alert will repeat itself every 5 minutes after the user press the Menu
7. GB rear arr am Rt ae et mer Ee NERY RN AE Ue 16 UN TERR NTC 17 4 E 17 Pec T We MON A 19 ADJUSTING THE 19 ALPRE AA 20 Genadyne Biotechnologies DMR03 091 Rev J Uo BER ABIT AA eR AA 22 IBS qu M 24 ADVANCE MENU 25 5 25 mo gd dire E 26 IE OUA 8564 26 BATTERY Rn nmn n nnn enne nenne eere ee rentes ee ese ee esee enis 27 WNEIdD 28 Fere aU T i 22 T 28 MERC KKu
8. Select button to enter into the Alert Setup function Navigate to the Alert Log by using the Up Down button and press the Menu Select button to enter into the Alert Log screen All the past 8 Alerts will be shown on the screen To acknowledged them scroll to the desired Alert notification and press the Menu Select button The Alert bell will stop once acknowledged The asterisk on the left side of the notification WILL NOT disappear until the problem is fixed 8 To toggle and show the time and date stamp please press the Lock Unlock key d pues To exit to the main screen press and hold on to the Exit Cancel button for 5 seconds Genadyne Biotechnologies DMRO03 091 Rev J The advance menu is for system setups and therefore untrained users should not navigating into this part of the system 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 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 5 Hit the o exit cancel button to exit to the
9. Select button to silence it Enable Disable The XLR8 provides the option for the user to enable or disable which Alert notifications they want to have turned on To Enable Disable the Alert 1 Press Menu Select button use the Up Down button to navigate to Alert Setup press the Menu Select button again to enter into the Alert Setup function 2 Press Menu Select button to select the Enable Disable function Genadyne Biotechnologies DMRO03 091 Rev J Im Biotechnologies Inc am Leak Alert Low Battery Blockage Canister Full Arrows on the side means enabled Critical Battery To select the desired Alert navigate to the desired Alert and press the Menu Select button once The arrow will appear on the 135 x side Genadyne Biotechnologies Inc Clem Leak Alert Low Battery Blockage Canister Full Critical Battery Disabled No arrows mm To disable the Alerts navigate to the desired 135 5 Alert and press Menu Select once to have the arrow disappear 4 exit to main screen press and hold the Exit Cancel button for 5 seconds Genadyne Biotechnologies DMRO03 091 Rev J Alert Log All Alerts are logged and saved in the KLR8 memory Only the last 8 alerts are displayed by which the latest alert will be the top of the list To enter into the Alert log 1 Press Menu Select button 2 Navigate to Alert Setup by using the Up Down button and press the Menu
10. XLR8 drape if necessary Step 3 Cutfoam to appropriate size of the wound Place the foam into the wound Avoid cutting the foam over the wound Do not over pack otep4 Cover foam with XLR8 drape Peel layers 1 2 and 3 Remove the handlers 3 otep5 Cuta hole on drape the middle of the foam approximately 1 in diameter Remove paper backing number 1 from the port pad Place over the hole Peel number 2 Remove handlers Actual port pad may be different from the picture The picture is for illustrative purposes only Genadyne Biotechnologies DMRO03 091 Rev J Step6 Connect the port pad tubing to canister tubing Ensure all clamps are unclamped at this time Step 7 Initiate therapy at the prescribed pressure turning the machine on otep8 Foam will collapse down and target pressure will be achieved Genadyne Biotechnologies DMRO03 091 Rev J Mo Maintenance Product must have scheduled diagnostic maintenance every 6 months or 4000 hours whichever comes first Failure to comply will void warranty Product will need to be opened and inspected between patient use by trained personnel or else please return to Genadyne for inspection Alternatively please contact Genadyne for a free training for performing maintenance on this unit Preventative maintenance consists of full inspection and diagnostics of unit replacement of internal tubing and battery if necessary replacement of
11. main screen Backlight This function allows the user to set the backlight to either brighter or dimmer according to the user s preference lock unlock Genadyne Biotechnologies DMRO03 091 Rev J 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 DMR03 091 Rev J Battery Power The KLR8 can both battery powered and while plugged in with the power adapter Please note that every time the power adapter is plugged in to the machine it is charging the battery While the machine is plugged in it does not affect or interfere with the therapy as the XLR8 machine will still function as it is ONLY USE THE POWER ADAPTER THAT CAME IN THE BOX DO NOT USE AN UNKNOWN POWER ADAPTER Battery life is between 296 to 2590 Battery life is between 25 to 5096 Battery life is between 50 to 7596 Battery life is between 75 to 100 Battery life is between 096 to 290 Alert notification will occur user needs to plug in the power adapter to recharge the battery Battery is charging Battery is fully charged
12. of the wound the volume of drainage the integrity of the dressing seal the assessment of bacterial burden and the patient s risk of infection Ensure that tubing and Port Dressing is installed completely and without any kinks to avoid leaks or blockages in the vacuum circuit Position the XLR8 Wound Care System and tubing appropriately to avoid the risks of causing a trip hazard Whenever possible the device and system tubing should be positioned level with or below the wound Genadyne Biotechnologies DMR03 091 Rev J ao Physician Orders As a condition of use the XLR8 System should only be used by qualified and authorized personnel The user must have the necessary knowledge of the specific medical application for which Negative Pressure Wound Treatment is being used 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 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 Dressing Changes Wounds being treated with the Genadyne XLR8 system should be monitored on a regular basis In a monitored non infected wound Genadyne XLR8 Dressings should be changed every 48 to 72 hours but no less than 3 ti
13. prescribed by the physician 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 XLH8 Therapy may be used O O O O CAUTION Do not place dressing directly in contact with Exposed blood vessels o Anastomotic sites o Organs o Nerves Oon Refer to Clinical Guide for additional information concerning Bleeding Genadyne Biotechnologies DMR03 091 Rev J 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 Variable Therapy Continuous rather than variable 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 Continu
14. returned in the original packaging Disposing of the device The device contains batteries Do not dispose of this device by placing it in the trash Return the device to Genadyne or use local procedures for battery disposal 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 Items 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 Items 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 Products Genadyne XLR8 Negative Pressure Wound Therapy System Genadyne Biotechnologies DMR03 091 Rev J Electromagnetic Compatibility Guidance and manufacturer s de
15. 230mmHg Suction capacity 4 Liters per Minute DIMENSIONS WEIGHT Dimension 9 9 L x 3 9 W x 2 1 150 mm x 99 mm x 53 mm Weight 1 5 Ibs 0 68 Expected service life ELECTRICAL REQUIREMENT Power 19 VDC 1 57A 30W Min 20 VDC Max Model MPU30B 5 Battery Type Li lon rechargeable batteries Recharge Time 3 Hours Safety EN55011 Class B UL cUL 60601 1 TUV GS EN60601 1 CE Mark LVD ENVIRONMENTAL CONDITIONS Operating Conditions 18 C to 34 C 65 F to 94 F Relative Humidity 10 to 95 STORAGE AND SHIPPING CONDITIONS Ambient Temperature O F to 110 F 18 C to 43 C Relative Humidity 10 to 95 Battery Shelf Life gt 2 weeks after a full charge Please charge to 100 before patient usage PATIENT PROTECTION Class Il per EN60601 1 Applied part Type BF per EN60601 1 COMPLIANCE EN 60601 1 2005 EN 60601 1 2 2007 EN ISO 14791 2012 EN ISO 10993 2009 EN ISO 11135 1 2007 EN ISO 11737 1 2006 AC 2009 Genadyne Biotechnologies DMR03 091 Rev J 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 Florida Obelis S A EU Representative 31 Tamara PI Unit 1 1500 W Cypress Creek Rd 410 Bd General Wahis 53 Brantford ON N3P 1M8 Ft Lauderdale FL 33309 1030 Brussels CANADA USA BELGIUM 1 888 787 2811
16. Double O rings replacement of odor patches and cleaning of the inside and outside of the unit This maintenance insures proper continued performance from the unit as well as maintaining the indicated battery run time Please contact your local distributor or Genadyne regarding the regular maintenance program of the device 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 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 Genadyne Biotechnologies DMR03 091 Rev J la Returning device For any returns or rental 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 UC Disposal of used canisters should follow facility protocols or local ordinances relating tothe handling of potentially infected or bio hazardous materials The device will also need to be
17. SHOULD NOT attempt to service or repair the Wound Vacuum System refer all servicing to Genadyne No user serviceable parts inside Genadyne Biotechnologies DMR03 091 Rev J Warnings DO NOT THIS 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 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 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 Power Adapters This system is internally powered with battery and externally powered with an approved Class II power adapter Note Only this Power adaptor may be used with the device Use of any other adaptor automaticaly voids warranty and may be hazardous to the patient and the operator E IEC 320 C8 Power Cord
18. 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 Note 1 At 80 MHz and 500 MHz the higher frequency range applies A Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people The Genadyne XLRS 15 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 Genadyne XLR8 as recommended below according to the maximum output 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 m 0 12 m 0 23 m 0 1 0 37 0 37 0 74 m 1 1 17 m 1 17 m 2 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 Genadyne Biotechnologies DMR03 091 Rev J 36 00 Technical Specifications VACUUM PUMP Service Life est 1 year Brushless motor Continuous Mode Min Vacuum 40mmHg Max Vacuum 230mmHg Variable Mode Min Vacuum OmmHg Max Vacuum
19. Therapy it 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 e 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 circulatory compromise 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 continuous piece to Genadyne Biotechnologi
20. and system is running on while the power adapter is plugged in Genadyne Biotechnologies DMRO03 091 Rev J Advance Features Lock Unlock Keypad To lock the keypad 1 Press and hold the duration of 7 seconds 2 When icon changes to 3 To unlock the keypad repeat step above 4 The icon will then change from Alert Log Clearing To clear the Alert log the user needs to go to the main screen Genadyne Biotechnologies Inc 1 Press and hold menu select button 2 Press the lt lock unlock and Treatment Time Sh 00m release while holding onto number 1 657 i mmHg 3 Press the exit cancel and release 0 while holding onto number 1 Negative Pressure Wound Therapy 4 Release the menu select 09 58 24 February 24 2009 Genadyne Biotechnologies DMR03 091 Rev J Treatment Time Reset Both Continuous and Variable To reset the treatment time the user needs to go to the main screen 1 Press and hold menu select button on off button and the A lock unlock button 2 Press and release in sequence the 3 Release the F menu select button 4 The treatment time will be reset to 00 00 00 Genadyne Biotechnologies DMR03 091 Rev J 9 Dressing Application Step 1 Choose appropriate size of KLR8 foam kit for wound otep2 Clean wound according to the agency facility protocol Protect wound edges with the
21. claration electromagnetic emissions The Genadyne XLR8 is intended for use in 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 CISPR 11 function Therefore its RF emissions are very low and 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 CISPR 11 including domestic establishments and those directly Harmonic emissions Class A connected to the public low voltage power supply network IEC 61000 3 2 that supplies buildings used for domestic purposes Voltage fluctuations flicker emissions Complies IEC 61000 3 3 Genadyne Biotechnologies DMR03 091 Rev J The Genadyne XLRS 15 intended for use in electromagnetic environment specified below The customer user of Genadyne XLR8 should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 IEC 60601 Test level 6 kV contact
22. en selecting 1 Treatment time Treatment time allows the user to set how long they want the patient to be on variable 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 remain 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 variable 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 variable therapy Down Time Time in seconds Variable Therapy 0 10 20 30 40 50 60 70 80 10 4 mmHg 20 gt Down Pressure Up Pressure 1 Treatment Time Genadyne Biotechnologies DMR03 091 Rev J FEN Selection select which therapy to use at anytime 1 Press the Menu Select button 2 Scroll using t
23. es DMRO03 091 Rev J IS minimize the risk of decreased distal circulation Extreme care should be taken to stretch the film when securing it 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 Operating Precautions Q When operating transporting repairing or disposing of XLR8 devices and accessories the risk of infectious liquids being aspirated or contamination of the device assembly through incorrect use cannot be eliminated Universal precautions should be observed whenever working with potentially contaminated parts or equipment As a condition of use the XLR8 Wound Care System should only be used by qualified and authorized personnel The user must have the necessary knowledge of the specific medical application for which NPWT is being used The XLR8 Wound Care System should remain on for the duration of the treatment If the patient must be disconnected the ends of the tubing should be protected using the tethered cap The length of time a patient may be disconnected from the XLR8 Wound Care System is a clinical decision based on individual characteristics of the patient and the wound Factors to consider include the location
24. he Up button or Down button and choose the Treatment Mode function by pressing the Menu Select button once 3 Choose either Continuous or Variable by pressing the Menu Select button once 4 For Continuous selection after Step 3 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 Variable selection after Step 3 press Menu Select button one more time to enter into the variable setting screen a Treatment Time Press the Menu Select button to enter the desired treatment time For continuous variable mode set the treatment time to Oh 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 Variable 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 is set press the Menu Select button again to confirm selection It will then bring you back to the Variable 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 vacu
25. mes per week with frequency adjusted by the clinician as appropriate Infected wounds must be monitored often and very closely For these wounds dressings may need to be changed more often than 48 72 hours the dressing change intervals should be based on a continuing evaluation of wound condition and the patient s clinical presentation rather than a fixed schedule Canister Selection The Genadyne system can only be used with the Genadyne XLR8 canisters The canister should be changed at least once a week or when full Canisters may have to be changed regularly within single patient treatment episodes if exudate levels are high Genadyne Biotechnologies DMR03 091 Rev J Introduction Information provided in this user manual contains important information regarding the safe and effective operation of the Genadyne KLR8 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 d 2 Y Accelerator Mode 25 UU ii i Therapy Mode Continuous or Variable wy Keypad Lock Unlock On OFF Button MENU SELECT Power Jack Inlet Lock Unlock Button y Genadyne Biotechnologies DMR03 091 Rev J Im System Usage The XLR8 must be used ONLY at these suggested orientations YES KEEP UPRIGHT NO NO Genadyne Biotechn
26. ologies DMRO03 091 Rev J Canisters 4 200 mil Canister Integrated 4 50002 400 mil Canister Set Integrated 4 50004 600 ml Canister Set Integrated 4 50006 900 Canister Set Integrated 4 50008 1100 ml Canister Set Integrated 4 500011 Dressing Solutions Foam Kit SMALL Foam kit XF DSMF 1 MEDIUM Foam kit XF DMDF 1 LARGE Foam kit XF DLGF1 SMALL Thin Foam kit XF DSMF1 T MEDIUM Thin Foam kit XF DMDF 1 T LARGE Thin Foam kit XF DLGF1 T X LARGE Thin Foam kit XF DXLF1 T XLR8 Film 4 500 5 XLR8 Port XP 1012 Genadyne Biotechnologies DMR03 091 Rev J Accessories yya Y connector for multiple wounds Carrying bag To use the carrying bag insert the KLR8 machine into the front pocket of the bag WITHOUT the canister attached to it Make sure the KLR8 is fitted tightly into the bag During usage attach the canister to the back and use the top and bottom flap and velcro them together to get a tight fit 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 DMR03 091 Re
27. ous therapy is also generally recommended for patients at increased risk of bleeding highly exudating wounds fresh flaps and grafts and wounds with acute enteric fistulae Genadyne Biotechnologies DMRO03 091 Rev J LI Patient Size 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
28. ovided by Genadyne may result in increased Electromagnetic Emissions or decrease in Immunity of the Wound Vacuum System When the Genadyne accessories Type BF applied part are used patient leakage current will not exceed limits set for this Device Class The USB port 15 blocked by tape Removing the tape invalidates the Warranty The use of the USB port 15 strictly limited to Genadyne Personnel WARNING Disregarding information on safety of this device 1s considered ABNORMAL USE To reduce the risk of burns electrocutions fire or injury to persons 1 This product should never be left unattended when plugged in 2 Close supervision is necessary when this product is used near infants or children 3 Use this product only for its intended use as described in this manual DO NOT use attachments or kits not recommended by Genadyne 4 NEVER operate this product if it has a damaged cord or plug any missing components 15 not working properly has been dropped or damaged or has been dropped into water 5 Keep the cord away from heated surfaces 6 NEVER use while sleeping or drowsy 7 not use in presence of flammable anesthetics 8 DO NOT operate where aerosol spray products are being used or where oxygen is being administered 9 The AC ADAPTER should be unplugged from the outlet when not in use When unit is not going to be used for an extended period of time store carefully in a cool dry place 10 The user
29. udates that may be stuck along the NPWT tubing This is to help ensure that consistent negative pressure is supplied to the wound bed 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 The adjustment to this pressure setting is being displayed by the large digit in the center of the LCD screen Each key press corresponds to either a 1 mmHg increment decrement By holding down the key it will gradually change to a 10 mmHg increment decrement Genadyne Biotechnologies DMR03 091 Rev J Alerts Before each new patient use it is recommended to erase the old alert log the machine to ensure that the new log will only reflect on the current user s usage To erase the alert log please refer to page 28 of this manual There are 5 Alert notifications in the XLR8 Leak Alert Whenever there is a leak in the dressing or the canister the Leak Alert alert will occur The Message on the screen will show ALERT LEAK OR LOSS OF SUCTION REVIEW DRESSINGS AND CANISTER CONNECTION TO UNIT ONCE LEAK IS RESOLVED PRESS MENU BUTTON TO CONTINUE THERAPY Canister Full Canister Full Alert occurs when the canister is filled with exudates The Message on the screen will show ALERT
30. um pressure is set press the Menu Select button to confirm selection It will then bring you back to the Variable 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 Variable setting screen e Down Pressure Press the Menu Select button to enter the desired low 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 Variable setting screen 6 To exit the variable 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 DMRO03 091 Rev J Accelerator Mode Accelerator mode is an optional feature that will start on every 10 minutes and continue to run for 15 seconds When the icon appears on the top left corner on the screen this means the unit is in accelerator mode Settings may different based upon the software version The Accelerator mode is a function that turns on automatically on a preset schedule to clear any ex
31. v J Operating device Starting Up Powering Down Press the Power Button aJ once The LCD will light up The pump will start running Suction is immediately available To Power Down the unit press the Power Button once A timer will appear on the main screen and start counting down If the Power Button was pressed by accident the user can press the Power Button again to turn on the machine and resume therapy The pump will always remember the previous settings before it was powered off Therapy Modes The Genadyne KLR8 provides the user with 2 therapy modes 1 Continuous 2 Variable Continuous Mode symbol is 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 variable therapy is in active Genadyne Biotechnologies Inc Genadyne Biotechnologies Inc uy Treatment Time 5h 00m Treatment Time 7h 00m Up Time 7m 125 mmHg Down Time 5m 0 mmHg mmHg mmHg 80 M M ll XLRE XLR amp Negative Pressure Wound Therapy Negative Pressure Wound Therapy 09 58 24 09 58 24 February 24 2009 February 24 2005 Continuous Mode Variable Mode Genadyne Biotechnologies DMR03 091 Rev J Variable Mode In Variable 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 wh
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