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Appendix 2

1. Leak Alarm Press Seal Check or for more information f this alarm is not resolved in three 3 minutes therapy will be interrupted Flashing green oval ap This alarm screen appears when the ActiV A C Therapy Unit detects a significant air leak This alarm will be accompanied by a repeating audible tone This alarm may be silenced for two 2 minutes during troubleshooting by pressing Audio Pause If this alarm is resolved within 3 minutes without using the Seal Check Tool the ActiV A C Therapy Unit will automatically reset and the Home screen will be displayed Pressing Reset on this screen to return to the Home screen To resolve this alarm 1 Ensure connector between dressing tubing and canister tubing is properly locked 2 Ensure canister is fully engaged See Canister NotEngaged Alarm a y Check 3 Press to use the Seal Check Tool to help identify leaks in dressing The patient s only access to the Seal Check Tool is through this Leak Alarm screen Seal Check The Seal Check feature provides an audible tone and bar graph to assist in finding leaks e The frequency of the audible tone and the height of the bar graph will reflect the leak rate e The audible tone frequency slows down and the bar graph decreases in height as the leak is found Seal Check E e Orange bar graph NE Line on bar graph is the indicates a
2. Therapy Delivery Modes Canister Volume Electrical Battery Run Life Battery Charge Time External Power Supply Input External Power Supply Output Patient 4 Enclosure Leakage Current Environmental Conditions Storage Conditions Temperature Range Relative Humidity Range Operating Conditions Temperature Range Relative Humidity Range Altitude Range Optimum Performance IEC Classification Medical Equipment Acti wh om E 19 3 x 15 2 x 6 4 cm 7 6 W x 6 Hx 2 5 D 1 08 kg 2 4 Ibs 25 to 200 mmHg 3 3 to 26 6 kPa Continuous or Intermittent 300 ml Approximately 14 hours depending on settings Approximately 6 hours from a fully discharged state 100 240VAC 72A 115VAC 47 63 Hz 12V 3 3 A lt 100 Microamps 20 C 4 F to 60 C 140 F 0 95 non condensing 5 C 41 F to 40 C 104 F 0 95 non condensing O to 4267 m 0 to 14 000 feet O to 2438 m 0 to 8 000 feet Equipment not suitable for use in presence of flammable anesthetic mixture with air oxygen or nitrous oxide Type B Applied Part Class IPXO Specifications subject to change without notice Acti wh om Es Customer Contact Information International KCI Europe Holding B V The Netherlands T 31 0 20 426 0000 F 31 0 20 426 0099 E mail info kci medical com Australia KCI Medical Australia Pty Ltd T 61 0 2 9630 8877 Orders 1300 KCI VAC 1300 524 8
3. Settings screen the clinician can Change Pressure settings Change Intensity Toggle between Continuous and Intermittent therapy Set Intermittent therapy times Press Exit when finished with the Settings screen and go to the Confirm screen GUIA C Settings cont Pressure Settings 1 Settings changed manually take immediate effect when therapy is on From the Clinician Mode Home screen press Therapy then Next then Settings then Pressure to access the Pressure screen Pressure Use the ba Pressure can be set from 25 to 200 mmHg in increments of 25 mmHg buttons to change to the desired pressure Press Exit to return to the Settings screen Default setting is 125 mmHg F Intensity Control 1 Settings changed manually take immediate effect when therapy is on From the Clinician Mode Home screen press Therapy then Next then Settings to access the Intensity button e Intensity is related to the time it takes to reach the target therapy level after the initiation of therapy e The lower the intensity setting the slower the target therapy level will be reached e ltis recommended that new patients begin therapy at the lowest intensity setting as this allows for slower increase of negative pressure once the foam is compressed in the wound e The intensity can remain at
4. WARNING Patients should not attempt to perform a change of settings and or therapy application without the express permission of the treating physician and or under the supervision of a trained clinical caregiver Press Cancel to return to the respective Help Menu screen How to access On screen Operating Instructions and Changing Languages are in the Help Menu section of this manual Acti wh IA E Clinician Utilities From the Clinician Mode Home screen press Utilities to access this screen Utilities Time Date Brightness PP TET AC Light Settings From this Utilities screen the clinician can Select Time Date to set the Time Date to current time and calendar date Select Region Settings to set the displayed Pressure Unit and set the Date Format Set the display Brightness of the Touch Screen User Interface Turn the AC Light On and Off Press Exit to return to the Clinician Home screen Changing Time and Date From the Clinician Mode Home screen press Utilities then press Time Date to access this screen Set Time Date Year Month Day Hour 24 Minute Use the ul buttons to set current time and calendar date Holding these buttons will rapidly scroll through available selections Press Exit to return to the Utilities screen Win Eo Clinician Utilities cont Changing Pressur
5. Amber light next to the bottom left of the Touch Screen User Interface will indicate charging is underway Refer to the Battery Charging section of this manual for more information To resolve this alert 2 Press Exit on this screen to return to the Home Screen V A C Therapy continues Battery Critical Alarm This alarm screen appears approximately thirty 30 minutes before the battery power level is too low to support continued operation of the ActiV A C Therapy Unit Battery critically low charge immediately This alarm will be accompanied by a repeating audible tone This alarm may be silenced for two 2 minutes during troubleshooting by pressing Audio Pause To resolve this alarm 1 Connect therapy unit to wall outlet using ActiV A C Power Supply to recharge battery An Amber light next to the bottom left of the Touch Screen User Interface will indicate charging is underway Refer to the Battery Charging section of this manual for more information 2 Press Reset on this screen to return to the Home Screen button 3 Ensure therapy is on by confirming that the green crescent is lit on the lt If not press to restart therapy WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours V A C Therapy continues however if this alarm is not resolved within thirty 30 minutes
6. Follow on screen instructions to unlock e Do not use any liquid to clean the Touch Screen User Interface e Use a soft non abrasive cloth to gently clean the Touch Screen User Interface Pressing too hard may damage the Touch Screen User Interface Daily Care and Cleaning Perform a visual inspection of the unit Check for any sign of contamination and ensure that the unit is functioning properly If there are signs of contamination or the unit appears dirty follow the Weekly Care and Cleaning instructions below If the unit is not operating properly refer to the Alerts and Alarms section of this manual or contact your healthcare provider or KCI Avoid spilling liquid on any part of the ActiV A C Therapy Unit Liquids remaining on electronic controls can cause corrosion which can cause the electronic components to fail Component failure may cause the ActiV A C Therapy Unit to operate erratically possibly O causing a potential hazard to patient or care providers Particular care must be taken when handling undiluted chlorine bleach including proper shielding of eyes Always mix solution by adding the concentrated chlorine bleach to the water Weekly Care and Cleaning To help reduce risk of infection and contact with blood and body fluids wear protective equipment when cleaning the ActiV A C Therapy Unit At least once per week the ActiV A C Therapy Unit should be wiped with a diluted solution of 5 milliliters bleach in
7. See picture 40 11 Press 3d on the Touch Screen User Interface to restart V A C Therapy Verify the dressing compresses Carrying Case Parts Identification rear view Flap covering y Center Zipper Multi function Hook with Covering Flap Buckles Y shown connected Tubing Storage Pocket with Zipper and Covering Flap Built in Belt Loop underneath Access Flap with Hook and Loop Fastener aiti WAA Eo Canister Change in Carrying Case 1 Open the Front Flap on the Carrying Case See picture 1 1 Front Flap V A C Therapy is already off if addressing a Canister ad Full Alarm Stop V A C Therapy by pressing yon the Touch Screen User Interface See picture 1 9 Do not turn power off to the ActiV A C Therapy Unit 2 Slide both tubing clamps toward the tubing connector See gt picture 2 A 3 Tightly close both tubing clamps Several clicks should be heard 3 gt See picture 3 2 4 Disconnect the dressing tubing from the canister tubing by 1 twisting the tubing connectors until the locking tabs are 4 disengaged 2 pulling the connector apart See picture 4 5 Close the Front Flap and turn the ActiV A C Therapy Unit over so that its Front Flap is facing down See picture 5 6 Unzip the Tubing Storage Pocket Zipper See picture 6 Remove the tubing from the Tubing Storage Pocket 7 Unzip the Center Zipper on the bac
8. for more information a ay 0 mmH To resolve this alert 1 Ensure both clamps on the dressing and canister tubing are open 2 Ensure that the tubing is not kinked crimped or blocked in any way 3 If the Blockage Alert remains after completing steps 1 and 2 lowering the therapy unit and tubing to the same level as or below the wound site may resolve this alert If the alert is cleared by lowering the unit normal use may resume 4 Press Exit to return to the Home screen The ActiV A C Therapy Unit continues to attempt to apply therapy Blockage Alarm Therapy Interrupted This alarm screen appears when the ActiV A C Therapy Unit has determined that a blockage is present WARNING Unit may be running but ee is interrupted Press 2 for more information lt This alarm will be accompanied by a repeating audible tone This alarm may be silenced for two 2 minutes during E cublechootro by pressing Audio Pause To resolve this alarm 1 Ensure both clamps on the dressing and canister tubing are open 2 Ensure that the tubing is not kinked crimped or blocked in any way 3 Ifthe Blockage Alert remains after completing steps 1 and 2 lowering the therapy unit and tubing to the same level as or below the wound site may resolve this alert If the alert is cleared by lowering the unit normal use may resume 4 Press Reset on this screen to return to the Home Screen WARNING Ther
9. Changing the Canister l Carrying Case Parts Identification Canister Change in Carrying Case Inserting the Therapy Unitinto the Carrying Case Carrying Case Configurations Clinician Mode Clinician Mode Home Screen Common Screen Control Buttons Navigation Buttons Clinician Operating Instructions Power the ActiV A C Therapy Unit On or Off Accessing Manual sila aiid Settings Pressure Settings Intensity Control Continuous and Intermittent Modes Intermittent Settings Settings Confirmation Continued on next page Acti AA Es Inside Front Cover 3 Acti Wh em Es Table of Contents cont Clinician Operating Instructions cont Settings Guide Ia oa 2 w a 26 Settings Guide Confirmation La ee ee ee ee we ee 9 Starting Therapy kee ee we ee oe se nm ow amp ae me ae Seal Check Overview see ee mw a amp Od How to Use Seal Check When Starting Therapy Pa e y amp oe Finding the Leak Using Seal Check E Log Tool Overview Es ros yd How to Use Log Tool When Starting Therapy _ ee oc ke ee nn 2 3 View or Export Therapy History 2 0 61m ee BH View Therapy History s e AE amp BEG 8 WO Export Therapy History Report sow OS a g a BO Troubleshooting USB or Infrared Export Problems ca e aA a BO Clinician Help Menu 7 r das te ow oe se se Ss amp oF Changing to Patient or Clin
10. Screen WARNING Press Reset and Restart Therapy User Interface being touched Press For more information Audio This alarm will be accompanied by a repeating audible tone SS This alarm may be silenced for two 2 minutes during troubleshooting by pressing Audio Pause To resolve this alarm 1 Press Reset on this screen to return to the Home Screen 2 Restart therapy by pressing 3 If V A C Therapy is not desired turn the ActiV A C Therapy Unit off by using the Power On Off CO button on the front of the unit WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours System Error Therapy Interrupted Alarm This alarm screen appears when there is a technical fault within the ActiV A C Therapy Unit MEEA Several different types of system errors may occur A number WARNING Turn therapy unit off then on if error continues contact KCI Press for more information will appear in the yellow alarm box that represents the diagnostic code of the technical fault Audio Pause This alarm will be accompanied by a repeating audible tone This alarm may be silenced for two 2 minutes during troubleshooting by pressing Audio Pause To resolve this alarm 1 Record the error number 2 Power the unit off and then on using the Power On Off CO button on the front of the unit 3 If error per
11. Wh Mm ES ActiV A C Therapy System Overview Specific features are detailed in the Patient Feature Identification section of this manual Touch Screen User Interface ActiV A C Canister KCI Authorized Maintenance Access Only USB Data Port Power Connection Battery Charging Indicator Light Power On Off Button f Infrared Data Port Typical V A C Dressing Not included with therapy unit SensaT R A C Pad ee dressing een il N SensaT R A C Pad V A C Drape k r y na i gt i Fi r i e eee IS f gt SensaT R A C Pad Tubing ES Connector V A C GranuFoam Dressing SensaT R A C Pad Tubing Clamp A variety of V A C Dressings are available for use with the ActiV A C Therapy System Acti Wh Me ES ActiV A C Therapy System Overview ActiV A C Power Supply Components AC Power Cord ActiV A C Charging Cord DC Power Supply Brick ActiV A C Carrying Case and Adjustable Strap Storage Pocket for the ActiV A C Quick Reference Guide Acti Wi hm C Internationalk User Manual English ActiV A C Quick Reference Guide O ENAC The Clinical Advantage Acti wh MA E Introduction V A C is short for Vacuum Assisted Closure V A C Therapy is a system that uses controlled negative pressure vacuum to create an environment that promotes wound healing by bringing the
12. canister is properly installed the canister cannot be removed by gently pulling the canister directly away from the unit 3 While therapy is on and using light pressure move your hand and fingers slowly around the edges of the drape and the SensaT R A C Pad The bar graph will lower and the audible tone if Seal Audio is on will slow down when the leak is found 4 Refer to the Application Instructions provided with V A C Dressings for information on using excess V A C Drape material to seal the leak area When finished with this screen press Exit to return to the Clinician Mode Home screen Starting Therapy cont Log Tool Overview e Log Tool can be used to record the number of foam pieces used during a dressing change e Log Tool can be used to record canister changes e Logged information is viewable and exportable on the Therapy History screens How to Use Log Tool When Starting Therapy Press on the Therapy Start screen to access this Item to Log screen a ee Choose Canister or Dressing Item to Log Press Exit to return to the Clinician Mode Home screen Press wE GA to access this Canister Replaced screen gt 7 Canister Replaced ED Press OK to log that the canister has been changed Will use the current time and date Press OK to log that the canister has been replaced and return to the Item to Log screen T
13. connector See A picture 2 e 3 Tightly close both tubing clamps Several clicks should be O y heard See picture A ai 4 Disconnect the dressing tubing from the canister tubing by 1 twisting the tubing connectors until the locking tabs are disengaged Agah d 2 2 pulling the connector apart See picture 4 5 Depress the Canister Latch Release See picture 6 Remove the canister from the therapy unit by pulling the canister directly away from the unit See picture Dispose of the canister according to institution and local environmental regulations Acti Wh A E Changing the Canister cont 7 Install the new canister onto the therapy unit by sliding the Canister Latch Guide opening in the canister over the Canister Latch Guide Ensure J wi the canister is installed directly onto the therapy unit See picture 7 Do not twist or turn the canister as it is being installed An audible click should be heard when canister is properly installed 8 Ensure the canister is securely installed on the therapy unit If the canister is properly installed the canister cannot be removed by gently pulling the canister directly away from the unit See picture 8 9 Reconnect the new canister tubing to the dressing tubing by 1 pushing the connectors together and 2 twisting the connectors until the locking tabs are fully engaged See picture 9 10 Open both tubing clamps
14. for a fee from your KCI representative gt Can the ActiV A C Therapy System be used when undergoing diagnostic procedures The chart below can be used to determine whether V A C Therapy can continue during specific procedures gt O WARNING It is important to note that the ActiV A C Therapy Unit cannot be taken Q into the Magnetic Resonance Imaging MRI suite or the Hyperbaric Oxygen Therapy HBO chamber See the V A C Therapy General Safety Information Sheet that accompanies the ActiV A C Therapy Unit for specific instructions concerning MRI and HBO therapy WARNING Under clinician supervision replace V A C Dressing with alternate 1 dressing if therapy is interrupted for more than two hours i Therapy Unit Therapy Unit DIOS Pie ee compatible NOT Compatible MRE TX ersen OR Dyess OR Fuoroscopy OR won AR There is a possibility of shadow casting in the area of the wound if the V A C Dressing is left in place for the diagnostic procedures that are indicated Therapy Unit Compatible The decision to keep the V A C Dressing in place or not should be made by the radiologist radiology technician and or the wound care practitioner Please note To help provide safe and effective use V A C Dressings are only to be used with V A C Therapy Units eo Acti wh A E Standard Precautions The following are the KCI recommended daily and weekly cleaning and infection control
15. hear the therapy unit stopping and starting therapy on off This is to ensure accurate delivery of pressure How do know if the ActiV A C Therapy Unit is working properly The Therapy Status Bar at the bottom of the Touch Screen User Interface indicates specific therapy information The rotating icon also found in the Therapy Status Bar indicates the ActiV A C Therapy Unit is applying negative pressure Wound fluid may or may not be seen moving in the tubing Q What if do not hear an audible click when installing a canister onto the ActiV A C gt PO FD Therapy Unit An audible click should be heard when installing a new canister Occasionally you may not hear an audible click If the canister is properly installed the canister cannot be removed by gently pulling the canister directly away fromthe unit Is the ActiV A C Canister specific to the ActiV A C Therapy Unit Yes the 300 ml canister is specifically designed to be used with the ActiV A C Therapy Unit What languages are available in the ActiV A C Therapy Unit When fully implemented the therapy unit is pre programmed with the following languages English Spanish Swedish Dutch German Italian French and Danish WARNING Languages should only be selected according to local regulatory Q requirements Q A Is the ActiV A C Therapy Unit allowed in flight Commercial airlines will allow the ActiV A C Therapy Unit to be carried
16. onboard with documentation from a physician typically in the form of a doctor s prescription The User Manual should also be available for presentation and not in checked baggage The label on the therapy unit and the User Manual identify the ActiV A C Therapy Unit as a medical device The security check point can be handled in one of two ways e The canister tubing and dressing tubing can be clamped and disconnected from each other This will allow the therapy unit and canister to go through security detection in a bin while the patient moves through the security scanner with the dressing in place e Alternatively the patient can keep the dressing attached to the therapy unit and have the security personnel hand wand the patient and therapy device Acti wh IA ES ActiV A C Frequently Asked Questions cont All airline rules and regulations regarding electronic equipment must be followed when traveling by air The device should be turned off in keeping with other electronic devices during take off and landing If the unit is off longer than 2 hours the V A C Dressing should be removed and replaced with an alternate dressing Are there any recommendations to note when traveling It is recommended that the patient travel with a fully charged battery an alternate dressing extra ActiV A C Canister and the User Manual Consult your clinician prior to traveling for patient specific recommendations A car adapter is available
17. the minimum setting throughout the entire length of treatment if desired Press to change levels Green crescent changes with each setting Low Medium High Intensity _ Intensity lt Intensity CUYA ES Settings cont Continuous and Intermittent Modes From the Clinician Mode Home screen press Therapy then Next then Settings to access this screen to switch between Continuous and Intermittent Therapy Settings E Pressure intensity The words Continuous or Intermittent will appear in this area as modes are switched Continuous Intermittent GUIDES When the Green Crescent is lit the ActiV A C Therapy Unit is in Continuous mode Continuous When the Green Crescent is unlit the ActiV A C Therapy Unit is in Intermittent mode o Default setting is Continuous Press Exit when finished with the Settings screen and go to the Confirm screen Intermittent Settings 1 Changing Intermittent time intervals will take effect next cycle From the Clinician Mode Home screen press Therapy then press Settings then press Intermittent to access this screen Intermittent amp ZA A PE y y On Time a buttons to change the desired On and Off Time in minutes Use the Both On and Off Times can be set from 1 minute to 10 minutes in 1 minute incremen
18. 0 F 971 4 20 454 16 E mail postmaster ME kci medical com Netherlands KCI Medical B V T 31 0 30 635 58 85 F 31 0 30 637 76 90 E mail infoNL kci medical com Norway KCI Medical AS T 47 0 6684 5100 F 47 0 6684 5099 Visitor s address Nye Vakasvei 12NO 1395 Hvalstad Singapore KCI Medical Asia Pte Ltd T 65 6742 6686 F 65 6749 6686 E mail postmasterSG kci medical com South Africa KCI Medical South Africa Pty Ltd T 27 0 11 315 0445 Fat 27 0 11 315 1757 E mail kcisa kci medical com Spain KCI Clinic Spain S L T 34 902 100 835 F 34 902 200 835 E mail postmastES kci medical com Sweden KCI Medical AB T 46 0 8 544 996 90 F 46 0 8 544 996 91 E mail postmasterse kci medical com Switzerland KCI Medical GmbH T 0848 848 900 T 41 0 43 455 3000 F 0848 848 901 F 41 0 43 455 3020 E mail postmasterCH kci medical com United Kingdom KCI Medical Ltd 24h Hotline 44 0 800 980 8880 T 44 0 1865 840 600 F 44 0 1865 840 626 E mail ukmarket kci medical com www kci medical com E mail kcifrance kci medical com Gy CE 5KAS 0473 July 2007 340076 Rev B
19. 1 liter 1 teaspoon bleach in 1 quart of warm water Use a soft cloth and wring out excess solution until the cloth is damp and not dripping Other cleaning solutions should not be used as they may damage the ActiV A C Therapy Unit Acti AA SS P S G This page ft intentionally blank VS Acti wh MA ES Manufacturer Information For additional information concerning the ActiV A C Therapy System contact your local KCI Representative or KCI The Clinical Advantage mi Manufacturer EC REP KCI USA INC KCI Medical Products UK Ltd San Antonio Texas 78219 USA Wimborne Dorset www kci1 com BH21 7SH United Kingdom www kci medical com 2007 KCI Licensing Inc All Rights Reserved All trademarks designated herein are property of KCI Licensing Inc its affiliates and licensors Those KCI trademarks designated with the symbol are registered and those designated with TM are considered to be proprietary trademarks or are pending trademark applications in at least one country where this product work is commercialized Most KCI products referred to herein are subject to patents or patent applications pile Gy CE BKA5 0473 Acti Wh em ES Explanation of Symbols Used Warning or Caution statement of possible hazard to system patient or staff Important Operational Information Caution Consult Accompanying Documents WARNING Consult Accompanying Documents Consult Instructions For Us
20. 22 F 61 0 2 9630 8855 Orders Fax 1800 KCI VAC 1800 524 822 E mail postmasterAU kci medical com Enquiries 1800 815 529 Austria KCI Austria GmbH T 43 0 1 86 330 F 43 0 1 86 330 6 E mail austria kci medical com Belgium KCI Medical Belgium bvba T free 0800 73411 T 31 0 30 635 58 85 F free 0800 73415 F 31 0 30 259 96 91 E mail infoBE kci medical com Canada KCI Medical Canada Inc T 1 905 565 7187 T free 1 800 668 5403 F 1 905 565 7270 E mail infocanada kci medical com Denmark KCI Medical ApS T 45 3990 0180 F 45 3990 1498 E mail postmasterdk kci medical com France KCI Medical Sarl T 33 0 169 74 71 71 T free 0 800 47 83 47 F 33 0 1 69 74 71 72 Germany KCI Medizinprodukte GmbH 24h Hotline 0800 783 3524 T 49 0 611 33544 0 freefax 0800 329 3524 F 49 0 611 33544 759 E mail postmasterDE Okci medical com Ireland KCI Medical Ltd T 353 0 14659510 T free 1800 333377 F 353 0 14659500 E mail postmastlE kci medical com Italy KCI Medical Srl T 39 02 457 1741 F 39 02 457 1742 10 E mail info_italy kci medical com Japan KCI KK Tel 81 3 3230 3854 Fax 81 3 3230 3856 Latin America KCI International T free 1800 531 5396 extension 6335 T 1 210 255 6335 Fiotd 210255 6991 E mail postmasterLSA kci medical com Middle East Rep Office KCI Medical Middle East T 971 4 20 454 2
21. Acti PA Eo International User Manual English The Clinical Advantage July 2007 340076 Rev B WARNING Important Safety Information accompanies this device Indications Contraindications Warnings Precautions and other Safety Information are contained in the V A C Therapy Safety Information Sheet located in the transit case The ActiV A C Quick Reference Guide is located in a pocket on the inside of the Front Flap of the Carrying Case To reduce risk of serious or fatal injury all caregilvers and patients must carefully read and follow all user instructions and safety information that accompany KCI products If there are questions or if the V A C Therapy Safety Information Sheet or Quick Reference Guide are missing immediately contact KCI See back cover of this User Manual for country specific contact information Table of Contents Important Safety Information Statement Important Safeguards ActiV A C Therapy System Overview Introduction Patient Mode Patient Home Screen Common Screen Control Buttons Navigation Buttons Patient Operating Instructions i Power the ActiV A C therapy Unit On c or Off l Therapy On or Off Audio Pause Help Menu Changing Languages ee On screen Operating Instructions Battery Charging Instructions Battery Charging Indicator Light Battery Charge Level Indicator Canister Changes Identifying Canister and Related Parts
22. Instructions selection screen Contact Information From this Operating Instructions screen one can browse the various Help Screens that are available Choose from e Operation instructions e Cleaning instructions and e Alarms for alarm descriptions and their suggested resolutions Press CG when finished Acti WWA E Battery Charging Instructions Use only the power supply provided with the ActiV A C Therapy Unit Using any other power supply may damage the ActiV A C Therapy Unit If environmental conditions specifically low humidity pose a risk of static electricity care should be taken when handling the ActiV A C Therapy Unit when it is out of the Carrying Case and plugged into an AC wall outlet In rare instances discharge of static electricity when in contact with the therapy unit may cause the Touch Screen User Interface to darken the therapy unit to reset or the therapy unit to turn off If unable to restart therapy by powering the therapy unit off and then on immediately contact KCI See back cover of this User Manual for country specific contact information WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours Power cords may present a tripping hazard Ensure that all cords are out of areas where people may walk The ActiV A C Therapy Unit comes witha rechargeable batte
23. and History access SS buttons Common Screen Control Buttons Most screens have one or more common control buttons These are accesses Help screens when available activates the Screen Guard feature to help prevent unintentional changes This feature should be used when cleaning the Touch Screen User Interface To release Screen Guard press 1 and then 2 Screen Guard is not a patient lock out feature Acti wh A ES Clinician Mode cont Navigation Buttons One or more of these buttons may appear on a screen E leaves that particular screen stops action in progress Nxt goes on to the next screen of that particular procedure returns to the previous screen of that particular procedure CI acknowledges the action is complete and displays the next screen gt Holding these buttons will rapidly scroll through available selections Acti WS IAE Clinician Operating Instructions CAUTION NOTICE TO PATIENTS This section contains specific information intended for clinicians ONLY Do not attempt to perform any applications or setting adjustments in this section without the express direction and supervision of your treating physician The ActiV A C Therapy Unitshould be delivered already set to the Clinician Mode The ActiV A C Therapy Unit will return to the Patient Mode after about 15 minutes of Touch Screen User Interface inactivity Refer to Clinician Help Menu sec
24. apy has been interrupted WARNING Press For more information This alarm will be accompanied by a repeating audible tone Audio Pause This alarm may be silenced for two 2 minutes during troubleshooting by pressing Audio Pause 2 E To resolve this alarm 1 Press Reset on this screen to return to the Home Screen 2 Restart therapy by pressing If the leak condition was not resolved the ActiV A C Therapy Unit will take several minutes to re identify that a leak exists before the Leak Alarm will reappear and provide the opportunity to continue troubleshooting a leak using the Seal Check Tool The patient s only access to the Seal Check Tool is through the Leak Alarm screen Should the leak not be resolved within three minutes this screen will once again appear and therapy will stop WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours If alarm condition cannot be resolved contact KCI See back cover of this User Manual for country specific contact information WI E Alerts and Alarms cont Blockage Alert This alert screen appears when the ActiV A C Therapy Unit has detected a potential blockage and is working to determine if a Blockage Alarm needs to be displayed Potential Blockage detected l This alert will be accompanied by a single audible tone Press
25. apy unit remains on however negative pressure at the wound may be below set pressure potentially compromising therapeutic benefits WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours If alarm condition cannot be resolved contact KCI See back cover of this User Manual for country specific contact information Acti Wh Mm ES Alerts and Alarms cont Low Pressure Alert This alert screen appears when the ActiV A C Therapy Unit has not aaa reached the selected therapy set pressure The measured wound pressure is below the set This alert will be accompanied by a single audible tone A a ea Press For more information To resolve this alert 1 Ensure both clamps on the dressing and canister tubing are open 2 Ensure that the tubing is not kinked crimped or blocked in any way 3 If the Low Pressure Alert remains after completing steps 1 and 2 lowering the therapy unit and tubing to be level with or below the wound site may resolve this alert If the alert is cleared by lowering the unit normal use may resume 4 Press Exit to return to the Home screen O V A C Therapy at a lower than selected pressure is still being applied Low Pressure Alarm Therapy Interrupted This alarm screen appears when the ActiV A C Therapy Unit has not reached the selected therapy set pressure and nega
26. ase open and with a canister attached Epernineesaler Appel ane ACERS FIAN and the Touch Screen User Interface facing down slide the ActiV A C Therapy Unit into the case ots slide the unit into the case After the ActiV A C Therapy Unit is completely in the case fold the Access Flap over the therapy unit Close the Center Zipper Wrap any excess tubing into a bundle Put the tubing into the Tubing Storage Pocket on the bottom of the Carrying Case Ensure there are no kinks or the tubing is not pinched as it is put in the Tubing Storage Pocket Excess tubing may present a tripping hazard Ensure that excess tubing is stored in the tubing pocket and Is out of areas where people may walk Close Tubing Storage Pocket Zipper Finished position with zippers and flaps closed Win Es Carrying Case Configurations The case can be worn over the shoulder with the strap adjusted for comfort a A personal belt can be threaded through the Built in Belt Loop on the back of the case The Shoulder Strap should be removed and the loose Buckles connected over the top of the case The case has a built in Multi function Hook located under a flap on the back of the case The case can be used with the Shoulder Strap removed the loose Buckles connected over the top of the case and the Multi function Hook over the top of a chair or other secure location A The case can be worn over the o
27. atient Mode Home screen shown below MAA Patient ode 58 23 15 38 A Therapy On or Off starts or stops V A C Therapy ED green crescent on the On Off button means V A C Therapy is on WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours Audio Pause MATA When the Audio Pause button is selected alerts that do not need immediate attention will be silenced for 60 minutes ES A Countdown Timer and Audio Pause Indicator will be displayed in the upper left hand corner of the screen 58 23 Alarms needing immediate attention override the Audio Pause feature See the Alerts and Alarms section of this manual for details on alarms and how to resolve them Ly Acti WWA Eso Help Menu Changing Languages Press to access the Help Menu Press the Globe upper left to access the Language screen Help Menu E Operating Clinician Instructions Mode 7 Comact X Information Use the A buttons to select the required language E anguage A WARNING Languages should only be selected ab English according to local regulatory requirements a Press CE when finished 00 On screen Operating Instructions Help Menu Press to access the Help Menu QS Operating Clinician Press Operating Instructions to access the Operating INS BES
28. e Clinician Use Only Keep Dry Tripping Hazard No Bathing or Showering Power On Off Serial Number Date of Manufacture Manufacturer EE C PsaBa DPE eo Approximate symbol Temperature Limits Symbol Authorized Representative in the European Community Not protected against harmful IPXO effects of water os Alternating Current Direct Current E Class II Type B Applied Part and Electronic Equipment Directive 2002 96 EC At the end of useful life dispose of all waste according to local requirements or contact your local KCI subsidiary or agent for advice Conforms with the Waste Electrical Conforms with the Medical Device C Directive 93 42 EEC and has been subject to the conformity 0473 procedures laid down in the council directive Medical Equipment classified with ESTA respect to Electrical Shock Fire and Mechanical Hazards Only in accordance with UL 60601 1 and to CAN CSA C22 2 No 601 1 Standards including JIS amendment by Underwriters Laboratory Inc UL us 5KA5 Medical Equipment classified with ESTA respect to Electrical Shock Fire Us and Mechanical Hazards Only in accordance with UL 60601 1 Standards including JIS amendment by Underwriters Laboratory Inc 5KA5 Refer to Explanation of Symbols Used if symbols appear on the product or accompanying documentation Specifications Dimensions Weight with empty canister attached Pressure Options
29. e Units and Date Format From the Clinician Mode Home screen press Utilities then press Region Settings to access this screen Regional Settings E DD MM YY MM DD YY Pressing Pressure Unit switches between mmHg millimeters of Mercury and kPa kilo Pascals units of measurement Pressing Date Format switches between displaying DD MM YY Day Month Year and MM DD YY Month Day Year formats Default settings are mmHg and MM DD YY Press Exit to return to the Utilities screen Changing Screen Brightness Pressing Brightness switches between three levels of display screen f Brightness brightness Brightnes Default setting is High es Medium Brightness Changing AC Light Pressing AC Light prevents the display backlight from dimming when the unit is properly connected to the ActiV A C Power Supply ina is K ACTUight Default setting is On an Acti wh Am Es Alerts and Alarms ATTENTION soirains ana nisms An Alert will be displayed on the Touch Screen User Interface when the ActiV A C Therapy Unit detects a condition that requires patient or caregiver attention Alerts will be accompanied by a single audible tone Press for more information An Alarm will be displayed on the Touch Screen User Interface when the ActiV A C Therapy Unit detects a condition that requires immediate patient or caregiver attent
30. e that the two Infrared Data Ports are properly aligned pointed directly at each other and are within 1 meter 3 feet of each other e Ensure that the lenses of the Infrared Data Ports are clean not significantly scratched or damaged e Press O to power the unit off and then on Retry exporting Therapy History e lf the above steps do not resolve the problem contact KCI See back cover of this User Manual for country specific contact information Acti Wi fom C Clinician Help Menu To access the Clinician Help Menu the unit must be in Clinician Mode Changing to Patient or Clinician Mode Press to access the Help Menu O wun a 0 Operating 7 Patient Operating Instructions Mode Instructions Contact Contact Information Information Press Patient Mode to go to Patient Mode Press Clinician Mode to go to Clinician Mode One of these confirmation screens will appear depending on which mode is being accessed PS Patient Mode gt Clinician Mode ED DA x LO For safe and effective therapy only Press OK to change the 1 C system to Patient Mode gt authorized caregivers should continue S Select CANCEL unless authorized Only authorized caregivers should access Clinician Mode Select Cancel unless authorized Press OK to proceed to Patient Mode Press and hold OK for at least 5 seconds to proceed to Clinician Mode
31. from the ActiV A C unit To access the USB or Infrared Data Ports the ActiV A C Therapy Unit must be removed from the Carrying Case Press the Export History button on the Therapy History screen to access this screen Export History E Export to IR Data is exported with unit serial number but without patient identifier The USB Data Port is to be used with non powered memory sticks and drives only No AC or battery powered drives computers computer equipment or other devices may be used Press Export to USB to use USB transfer Follow screen directions Press Export to IR to use IR Infrared transfer Follow screen directions Press Exit to return to the Therapy History screen Troubleshooting USB or Infrared Export Problems USB e Ensure that the USB flash drive memory stick being used is USB 2 0 compatible e Ensure that the flash drive is fully plugged into the therapy unit It may be necessary to unplug and re plug the flash drive into the therapy unit e Try using a different USB flash drive e Remove the flash drive Press O to power the unit off and then on Retry exporting Therapy History e lf the above steps do not resolve the problem contact KCI See back cover of this User Manual for country specific contact information Infrared e Ensure that the Infrared Data Port on the receiving device is turned on and is in the receiving mode e Ensur
32. gs Guide cont Select Pressure Cance Select Within Available Range A Use the A buttons to select from the available pressure selections Pressure selections are in ranges for the wound type selected on the previous screen Press Next when finished with this screen For wound types for which Intermittent is an option this Select Mode screen will appear If Intermittent is not an option the Confirm screen will appear see next page Vv x 0 Select Mode ge amp Intermittent Oz Sy Vo Use the A buttons to choose Continuous or Intermittent Therapy Press Next when finished with this screen Acti wh IAE Settings Guide cont If Intermittent Therapy was chosen on the previous screen this Intermittent screen will appear Intermittent E ne A A Off Time El On Time dl Use the A Both On and Off Times can be set from 1 minute to 10 minutes in 1 minute increments buttons to change the desired On and Off Time in minutes Press Exit when finished with this screen Settings Guide Confirmation Settings take effect after OK is pressed Once the settings are chosen this Confirm screen will appear o O Confirm Partial Thickness Burns o SS Pressure 125 mmHg Mode Intermittent Intensity Low If the displayed settings are as desired press OK to c
33. he current time and date will be recorded Press Cancel to return to the Item to Log screen without logging an entry e Acti wh A E Starting Therapy cont Press MESS to access this Foam Pieces screen Foam Pieces ve Press OK to log number of foam pieces and time date Last recorded on 15 55 12 06 06 O Information displayed represents the last logged entry Use the buttons to change the number of pieces offoam used during the current dressing change Press OK to log the number of foam pieces used and return to the Item to Log screen The current time and date will be recorded Press Cancel to return to the Item to Log screen without logging an entry 1 Always document the number of foam pieces used in patient chart and on the V A C Drape Logged information will appear in Therapy History as follows dd mm yy Time Event 12 06 06 15 54 Canister Changed 12 06 06 15 55 Dressing Changed 4 Where the numeral after Dressing Changed is the number of foam pieces recorded on the above screen View or Export Therapy History Therapy History is a chronological log with dates and times for therapy starts stops therapy settings alarm occurrences and canister dressing changes Data can be reviewed on screen or transferred from the ActiV A C Therapy Unit electronically in the form of a Therapy History Report Starting from the Clinician Mode Home scree
34. ician Mode os NA a amp w 2 mm 4 OF Clinician Utilities eF we bs y eee ew Cd oe te ss yde Changing Time and Date OP AO 8 Changing Pressure Units and Date Format Lee OAY s oa a s s a roo Changing Screen Brightness O ao aa 8 Changing AC Light RALAN MD 399 Alerts and Alarms E E amp we se amp Important Information About Alerts and Alarms o amp amp eS amp amp 2 amp amp BD Index of Alerts and Alarms 4 gt 6 e 40 Frequently Asked Questions yY N aoa 2 2 ew ee ee 5D Standard Precautions Q 2 ew ee ee DBZ Care and Cleaning lt lt 2 2 we l a D Manufacturer Information wee ee DD Explanation of Symbols Used 0 5G Specifications a ooo OT Customer Contact Information a Back Cover Acti We IAE Important Safeguards WARNING As with all prescription medical devices failure to follow product instructions or adjusting settings and performing therapy applications without the express direction and or supervision of your trained clinical caregiver may lead to improper product performance and the potential for serious or fatal injury For medical questions please consult a physician Important Safety Information is located in the transit case and the ActiV A C Quick Reference Guide is located in a pocket on the inside of the Front Flap of the Car
35. ile 300 ml wound exudate collection canister Intensity Setting Intensity is related to the time it takes to reach the target therapy level after the initiation of therapy The lower the intensity setting the slower the target therapy level will be reached Therapy Days Display Screen will display the number of days since V A C Therapy was first initiated on the patient V A C Dressings A variety of V A C Dressings are available for use with the ActiV A C Therapy System control procedures Refer to the Care and Cleaning section for recommended daily and Refer to the Standard Precautions section of this manual for information on infection weekly cleaning for the ActiV A C Therapy Unit Acti wh IA E Patient Mode Patient Home Screen Audio Pause Indicator with ix 2 Patient Mode Mode Indicator AMIA 022 Countdown Timer sos oe 16 38 Current Date Current Time Therapy On Off Audio Pause Therapy Status Button Bar and Display A E Area Screen Guard Help Button This icon rotates when the This plug indicator ActiV A C Therapy Unit is Battery Level Indicator appears while plugged applying negative pressure into a wall outlet A green lighted crescent ES An unlit crescent means the function is on means the function is off starts or stops V A C Therapy ASES When the Audio Pause button is selected alerts that do not need immediate at
36. ion in order to ensure the prescribed therapy is being delivered Alarms will be accompanied by a repeating audible tone MEAD to silence the audible tone for 2 minutes If alarm conditions cannot be resolved contact KCI See back cover of this User Manual for country specific contact information Index of Alerts and Alarms Battery Low Alert O A Battery Critical Alarm E ee ow Be oe et ee a Oe we ee Canister Full Therapy Interrupted Alarm ea 42 Canister Not Engaged Alarm 483 Leak Alarm aa A Seal Check a 4 Leak Alarm Therapy Interru sied oe og os amp ok 2 a e aooo amp amp a E a BO Blockage Alert aaa 46 Blockage Alarm Therapy Interrupted aaa 46 Low Pressure Alert 22a a a a a aa A Low Pressure Alarm Therapy Interrupted aaa 47 Therapy Inactive Alarm A AAA ek ee e E System Error Therapy Interrupted Alarm 48 Service Timer Expired Alert 2 49 Acti Wi eS Alerts and Alarms cont Battery Low Alert This alert screen appears approximately two 2 hours before ES the battery power level is too low to support continued operation of the ActiV A C Therapy Unit Battery Low charging required This alert will be accompanied by a single audible tone O 9 1 Connect therapy unit to wall outlet using ActiV A C Power Supply to recharge battery An
37. k of the case Undo the Hook m7 and Loop Fastener on the Access Flap and fold the Access Flap q back to begin to expose the canister See picture 7 WI E Canister Change in Carrying Case cont E a ie a 8 Grasp the ActiV A C Therapy Unit in one hand and turn the unit and case so that the canister is facing up Continue to fold the Access Flap back until the canister is fully exposed See pictures and 6h Cancers 9 Position the ActiV A C Therapy Unit so that a the Canister Latch Release can be pressed toward the 50ml graduation mark See picture Qa Press the Canister Latch Release and remove the canister from the therapy unit See pictures a and b Dispose of the canister according to institution and local environmental regulations 10 Install the new canister onto the ActiV A C Therapy Unit by sliding the opening in the canister over the Canister Latch Guide Do i aim je not twist or turn the canister as itis being installed See picture 10a Push the canister onto the therapy unit An audible click should be heard See picture oy 11 Ensure the canister is securely installed on the therapy unit Ifthe canister is properly installed the canister cannot be removed by gently pulling the canister directly away from the therapy unit Ensure that no part of the case is between the canister and the ActiV A C Therapy Unit GT 12 Pull the Access F
38. lap back over the canister and ActiV A C Therapy Unit so that the canister is covered by the case Access See pictures and 120 Flap Acti WWA Es Canister Change in Carrying Case cont 13 Secure the Hook and Loop Fastener See Picture Close the Center Zipper over the canister See picture 14 Reconnect the new canister tubing to the dressing tubing by 1 pushing the connectors together and 1 aby i a 2 twisting the connectors until the 2 gt locking tabs are fully engaged See picture Open both tubing clamps See picture ab 15 Wrap any excess tubing into a bundle and put the tubing into the Tubing Storage Pocket on the bottom of the Carrying gt Case See picture 52 Ensure there are no kinks or the tubing is not pinched as it is put in the Tubing Storage Pocket Excess tubing may present a tripping hazard Ensure that excess tubing is stored in the tubing pocket and is out of areas where people may walk Close the Tubing Storage Pocket Zipper See picture 5p 16 Picture shows the Carrying Case with 17 the zippers and flaps in their final position Front Flap 17 Turn the Carrying Case front side up Open the Front Flap and restart V A C Therapy by pressing See picture 17 18 When finished close the Front Flap Acti Wh IAE Inserting the Therapy Unit into the Carrying Case Q Start with the empty case Hold the c
39. m of the Touch Screen User Interface O Fully Battery Battery Charged Use Low Critical Charge battery soon Charge battery immediately Acti wi Am C Canister Changes Identifying Canister and Related Parts Canister Latch Guide on the therapy unit may have sharp edges Do not handle the ActiV A C Therapy Unit by the Canister Latch Guide When not in use always store the ActiV A C Therapy Unit in the Carrying Case without a canister in place Silicone Seals ieee Canister Latch Guide Canister Stabilization Bumpers Contact KCI if the Silicone Seals Canister Latch Guide or the Canister Stabilization Bumpers are damaged or missing See back cover of this User Manual for country specific contact information Canister Latch Release Canister is always applied straight on and straight off the ActiV A C Therapy Unit Do not twist or turn canister when installing or removing Acti AA E Changing the Canister _ See Canister Change in Carrying Case section for change instructions when in the Carrying Case The ActiV A C Canister should be changed when full the alarm will sound or at least once a week to control odor V A C Therapy is already off if addressing a Canister Full Alarm 1 Stop V A C Therapy by pressing on the Touch Screen User Interface O Do not turn power off to the ActiV A C Therapy Unit i Der A r 2 Slide both tubing clamps toward the tubing
40. n press Therapy then Next then History to access this screen Therapy History E View History Export History The Therapy History screen has two options e View History View Therapy History on screen e Export History Access to screens where the Therapy History Report can be transferred via USB or IR Infrared View Therapy History Press the View History button on the Therapy History screen to access this on screen therapy history display History Exit dd mm yy Time Event gt 12 06 06 15 48 Unit On 12 06 06 15 48 Therapy On 12 06 06 15 54 Canister Changed 12 06 06 15 55 Dressing Changed 4 12 06 06 2223 Canister Full 12 06 06 2223 Therapy Off 12 06 06 22 27 Therapy On 12 06 06 22 29 Auto Therapy Off Leak 12 06 06 22 32 Therapy On buttons to scroll through the Therapy History Report Use the Holding these buttons will rapidly scroll through the Therapy History Report y Press Exit to return to the Therapy History screen Acti Wh A E Export Therapy History Report NOTICE This data is protected by copyright law and is likely to be confidential It is intended only for use by or for KCI or clinicians using KCI products This data is not directly associated with a particular patient Since this data can be altered if transferred to a different media the data may only be considered original when downloaded directly
41. o not connect or attach V A C Therapy units or its components to devices not recommended by KCI e Keep the ActiV A C Therapy System away from heated surfaces e Although the ActiV A C Therapy System conforms to the intent of the standard IEC 60601 1 2 in relation to Electromagnetic Compatibility electrical equipment may produce interference If interference is suspected separate the equipment and contact KCI See back cover electronic components fo fail Component failures may cause the unit to operate erratically possibly producing potential hazards to patient and staff Q Liquids remaining on the electronic controls can cause corrosion that may cause the e Avoid spilling fluids on any part of the ActiV A C Therapy Unit a e If spills do occur unplug the unit immediately if plugged into electrical source and clean the unit with an absorbent cloth Ensure there is no moisture in or near the Power Connection and Power Supply Components before reconnecting power If the ActiV A C Therapy Unit is not working properly contact KCI See back cover of this User Manual for country specific contact information E Do not use ActiV A C Therapy Unit while bathing showering or where it can fall or be pulled into a tub shower or sink e Do not reach for a product that has fallen into water Unplug the unit immediately if plugged into electrical source Disconnect the unit from dressing and contact KCI See back cover Acti
42. ompanying V A C Therapy Safety Information Sheet located in the transit case Quick Reference Guide located in the pocket on the inside of the Front Flap of the Carrying Case and this User Manual prior to use ActiV A C Therapy System Key Features Touch Screen User Interface The Touch Screen User Interface allows for easy navigation through operational and help menus A Screen Guards available to help prevent unintentional changes Battery Operation In order to facilitate mobility and help patients return to daily activities battery operation is available with the ActiV A C Therapy Unit During typical usage the battery may provide up to 14 hours of operation before needing to be recharged On Screen Operating Instructions Abbreviated Operating Instructions are available on screen Always familiarize yourself with and refer to this manual for detailed and specific information for use Seal Check Tool This tool assists in finding air leaks in the SensaT R A C System and dressing through the use of audible tones and on screen visual aids during the troubleshooting process Carrying Case A convenient Carrying Case is provided to allow discreet delivery of therapy It is recommended that the ActiV A C Therapy Unit always be kept in the Carrying Case Introduction cont Patient Mode Control Selection of Patient Mode by the clinician can help prevent unauthorized access to therapy set up screens Pa
43. ontinue to the Clinician Mode Home screen Otherwise press Back to change any settings that are incorrect Settings Guide Intensity default is low Intensity can only be changed using the Manual Therapy Settings ati wh Ae E Starting Therapy WARNING Ensure that a new V A C Dressing was applied and therapy settings have been selected per physician s orders before starting therapy a Clinician Mode Acti Wh Mm ES tun 22 2006 1938 Press to start therapy and this Therapy Start screen will appear Log Tool From this screen the clinician can use the Seal Check Tool to view the integrity of the V A C Dressing The clinician can also use the Log Tool to record a canister change or the number of foam pieces used during a dressing change Seal Check Overview Patients only have access to the Seal Check Tool through the Leak Alarm screen when the ActiV A C Therapy Unit detects a possible leak e Seal Check is used to help find air leaks e Seal Check features an audible tone that speeds up or slows down as the leakage rate changes Pressing the Seal Audio button will switch between the audible tone being On or Off e Seal Check also features a real time bar graph that gives a visual indication of the leakage rate The Seal Check Tool appears three 3 different ways 1 When therapy is started from the Clinician Mode Home screen discussed on the following page
44. oon of the product to the palm of the hand e Rub hands together covering all surfaces of the hands until they are dry If hands are visibly dirty however wash with soap and water rather than a sanitizer Wash hands before and after direct contact with the patient When using gloves wash hands immediately after gloves are removed between patient contacts and when necessary to avoid transfer of microorganisms to other patients or environments It may be necessary to wash hands between tasks and procedures on the same patient to prevent cross contamination of different body sites Gloves Wear medical gloves when touching blood body fluids secretions excretions and contaminated items Medical gloves may be clean and non sterile latex or latex free Put clean gloves on just before touching moist areas such as mucous membranes and non intact skin Change gloves between tasks and procedures on the same patient when gloves become contaminated or soiled Remove gloves promptly after use before touching non contaminated items and environmental surfaces Gloves do not provide complete protection against hand contamination Hands should be washed immediately after completed tasks or procedures to avoid transfer of microorganisms to other people or environments Mask Eye Protection Face Shield Wear a mask and eye protection or a face shield to protect the mucous membranes of the eyes nose and mouth during procedures and patient care activitie
45. pposite shoulder with the strap adjusted for comfort The attached Shoulder Strap can be removed from the Buckles and threaded through the Built in Belt Loop on the back of the case The loose Buckles should be connected over the top of the case The ActiV A C Therapy Unit can be carried in the hand by removing the shoulder strap and connecting the loose Buckles over the top of the case Excess tubing may present a tripping hazard Ensure that excess tubing is stored in the tubing pocket and is out of areas where people may walk When worn or carried therapy unit should always have the canister pointing down Ensure that the Buckles are properly snapped together Acti wh ew E Clinician Mode Clinician Mode Home screen Giirician Mode _ Mode Indicator Therapy On Off a 188 Current Date Button Current Time Therapy Status Bar and Display Area Help Button Screen Guard a ee This icon rotates when the Battery Level Indicator This plug indicator ActiV A C Therapy Unit is appears while plugged applying negative pressure into a wall outlet means the function is off ec A green lighted crescent E An unlit crescent means the function is on starts or stops V A C Therapy Uli accesses Region Settings and Time Date access buttons Screen Brightness and AC Light buttons Thetepy PR Settings Seal Check Tool Settings Guide
46. procedures for the ActiV A C Therapy Unit 1 Always follow Standard Precautions Standard Precautions are designed to reduce the risk of transmission of microorganisms from both known and unknown sources of infection These precautions can be applied to all patients regardless of their diagnosis or presumed infection status Standard Precautions should be used when contact is anticipated with blood and all body fluids This also includes secretions and excretions except sweat regardless of whether blood is visible or not non intact skin i e open wounds and mucous membranes Hand Washing Proper hand washing is the most important step in preventing the spread of infection Follow these steps to properly wash hands Wet hands with warm running water and apply liquid or clean bar soap Lather well Rub hands together vigorously for at least 15 seconds scrub all surfaces including the backs of hands wrist between fingers and under fingernails Rinse well Dry hands with a clean or disposable towel Use a towel to turn off the faucet Alcohol based hand sanitizers are a good alternative when soap and water are not available They have been shown to be more effective than soap and water in decreasing the number of bacteria and viruses Use only alcohol based products since the hand sanitizers without alcohol do not have the same effect To properly use an alcohol based sanitizer follow these steps e Apply about Y teasp
47. rmation This alarm will be accompanied by a repeating audible tone Audio Pause This alarm may be silenced for two 2 minutes during troubleshooting by pressing Audio Pause To resolve this alarm 1 Remove the canister by pressing the Canister Latch Release on the canister 2 Inspect the canister and ActiV A C Therapy Unit to ensure no foreign objects or debris interfere with the canister and therapy units mating surfaces 3 Ensure both Silicone Seals and both Canister Stabilization Bumpers are present Silicone Seals If Silicone Seals or Canister Stabilization Bumpers are missing or damaged contact KCI See back cover of this User Manual for country specific contact information Canister Stabilization Bumpers 4 Re attach the canister to the ActiV A C Therapy Unit ensuring that the canister is fully engaged and latched An audible click should be heard when canister is properly installed 5 Press Reset on this screen to return to the Home Screen 6 Restart therapy by pressing 7 If this alarm continues to appear repeat steps 1 through 6 with a new canister If alarm condition cannot be resolved contact KCI See back cover of this User Manual for country specific contact information WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours Acti Wh Mm ES Alerts and Alarms cont
48. ry The battery is not user accessible or serviceable The power supply has a two part cord one that plugs into an AC wall outlet and one that plugs into the ActiV A C Therapy Unit Battery Charging Indicator Light Plug to DC Power Supply Brick Battery Level Indicator location Charging Cord Connector AC Power Cord AC Wall Plug Acti WWA Es Battery Charging Instructions cont Steps are numbered in order See picture on previous page Plug the AC Power Cord into the DC Power Supply Brick Plug the AC Wall Plug into an AC wall outlet Locate the Arrow on the ActiV A C Charging Cord Connector With ActiV A C Touch Screen User Interface facing up the Arrow should also be up as the Charging Cord Connector is plugged into the Power Connection on the ActiV A C Therapy Unit BONO It should take approximately 6 hours to fully recharge the battery from a completely discharged state To maximize battery life keep the unit plugged in when the patient is not mobile for significant periods Battery Charging Indicator Light When the ActiV A C Therapy Unit is correctly plugged into the ActiV A C Power Supply the Battery Charging Indicator Light will gow Amber as the battery is charging When the battery has reached full charge the Battery Charging Indicator Light will glow Green Battery Level Indicator The battery level is shown on the botto
49. rying Case If the V A C Therapy Safety Information Sheet or Quick Reference Guide are missing immediately contact KCI for a replacement See back cover for contact information In order for KCI products to provide safe and proper performance e The product must be used in accordance with this manual e Itis recommended that the ActiV A C Therapy Unit always be kept in the Carrying Case when in use e TheActiV A C Therapy System may present a tripping hazard if placed on the floor Ensure that the ActiV A C Therapy Unit is not placed in areas where people may walk e Please note To help provide safe and effective use V A C Dressings are only to be used with V A C Therapy Units e All assembly adjustment modification maintenance and or repair should be carried out by qualified personnel authorized by KCI e The electrical installation of the room must comply with the appropriate electrical wiring standards e Refer to the Standard Precautions section of this mmanual for information on infection control procedures Refer to the Care and Cleaning section for recommended daily and weekly cleaning for the ActiV A C Therapy Unit e Never operate this product if it has avdamaged power cord power supply or plug Should the power cord power supply or plug be found to be worn or damaged contact KCI See back cover e Never drop or insert any object into any opening or tubing of the ActiV A C Therapy System e D
50. s 2 When the Seal Check button is pressed from the Therapy screen 3 When the Seal Check button is pressed on the Leak Alarm screen after the ActiV A C Therapy Unit detects a possible leak acti WWA A_C Starting Therapy cont How to Use Seal Check When Starting Therapy Pressing located on the Clinician Mode Home screen will immediately display this Therapy Start screen Orange bar graph indicates a significant leak Seal Check Tool Green bar graph indicates that the ActiV A C Therapy System is Press to turn the Seal Audio operating normally _ d tone On or Off Line on bar graph is the transition point from green to orange and vice versa The Seal Check feature provides an audible tone and aar graph to assist in finding leaks e The frequency of the audible tone and the height of the bar graph will reflect the leak rate e The audible tone slows down and the bar graph decreases in height as the leak is found During initial dressing draw down the bar graph should turn orange and then return to a green state if there are no significantleaks Most leaks occur e where the drape meets the skin e where the SensaT R A C Pad is attached to the drape e attubing connections Finding the Leak Using Seal Check 1 Ensure connector between dressing tubing and canister tubing is properly locked 2 Ensure the canister is securely installed on the therapy unit If the
51. s that are likely to generate splashes or sprays of blood body fluids secretions and excretions Acti WS IA Es Standard Precautions cont Gown Wear a gown a clean non sterile gown is adequate to protect skin and to prevent soiling of clothing during procedures and patient care activities that are likely to generate splashes or sprays of blood body fluids secretions or excretions Select a gown that is appropriate for the activity and amount of fluid likely to be encountered Remove a soiled gown as promptly as possible and wash hands to avoid transfer of microorganisms to other people or environments Patient Care Equipment Handle used patient care equipment soiled with blood body fluids secretions and excretions in a manner that prevents skin and mucous membrane exposures contamination of clothing and transfer of microorganisms to other patients or environments Linen Handle transport and process used linen soiled with blood body fluids secretions and excretions in a manner that prevents skin and mucous membrane exposures and contamination of clothing and that avoids transfer of microorganisms to other people patients and environments Waste Disposal Discard all disposable items all tubing connectors clamps used canister used dressings etc in accordance with local medical waste disposal regulations Care and Cleaning Cleaning the Touch Screen User Interface e Lock the Touch Screen User Interface by pressing
52. significant leak High transition point from green to orange and vice versa e Green bar graph indicates that the ActiV A C o Therapy System is operating normally Press to turn the Seal Audio tone on or Off Finding the Leak Most leaks occur _ e where the drape meets the skin e where the SensaT R A C Pad is attached to the drape e attubing connections Acti Wh Mm ES Alerts and Alarms cont Leak Alarm cont 4 While therapy is on and using light pressure move your hand and fingers slowly around the edges of the drape and the SensaT R A C Pad The bar graph will lower and the audible tone if Seal Audio is on will slow down when the leak is found 5 Refer to the Dressing Application Instructions for Use provided with V A C Dressings for information on using excess V A C Drape material to seal the leak area 6 Once the leak is resolved using the Seal Check Tool press E on the Seal Check screen to return to the Home screen 7 Once the leak is resolved ensure that V A C Therapy is on by observing that the green crescent Is lit on the O button and the icon is rotating on the Home screen If this alarm is not resolved within 3 minutes the Leak Alarm Therapy Interrupted alarm will appear and therapy will stop Leak Alarm Therapy Interrupted This alarm screen appears when the ActiV A C Therapy Unit has detected a leak that has not been resolved and ther
53. sists contact KCI See back cover of this User Manual for country specific contact information WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours Acti Wi IA ES Alerts and Alarms cont Service Timer Expired Alert Service Timer Expired This alert screen appears when the ActiV A C Therapy Unit has reached its service time limit Contact KCI Days Left 3 Once the Service Timer has expired this alert will appear every time the unit is powered up Enter Code Continue S S When Days Left reaches 0 zero this alert will reappear E periodically during therapy To resolve this alert 1 Contact KCI to obtain a new Service Timer code See back cover of this User Manual for country specific contact information 2 Press Enter Code to enter the code obtained from KCl Acti gt Q FD gt O gt O PA C ActiV A C Frequently Asked Questions How much does the ActiV A C Therapy Unit weigh The ActiV A C Therapy Unit weighs 1 08 kg 2 4 lbs with an empty canister installed How long does it take to charge the battery and how long will a fully charged battery last It takes approximately 6 hours to fully charge the battery The ActiV A C battery can maintain a charge up to 14 hours The ActiV A C Therapy Unit is sometimes noisy Why is this During normal operation it may be possible to
54. tention willbe silenced for 60 minutes A Countdown Timer and Audio Pause Indicator will be displayed in the upper left hand corner of the screen Alarms needing immediate attention override this feature Common Screen Control Buttons Most screens have one or more common control buttons These are accesses Help screens activates the Screen Guard feature to help prevent unintentional changes This feature should be used when cleaning the Touch Screen User Interface To release Screen Guard press 1 and then 2 acti WAA ES Patient Mode cont Navigation Buttons One or more of these buttons may appear on a screen EJ leaves that particular screen ED stops action in progress Cc goes to the next screen of that particular procedure returns to the previous screen of that particular procedure CI acknowledges the action is complete and displays the next screen Acti wh rw E Patient Operating Instructions Power the ActiV A C Therapy Unit On or Off Press and hold the Power On Off button for approximately 2 seconds to turn the ActiV A C Therapy Unit On or Off The Power On Off button is located immediately below and to the left of the Touch Screen User Interface Refer to the Patient Feature Identification section for more information The ActiV A C Therapy Unit will go through a self check routine and then presents a Warning Message screen Press OK to continue to the P
55. therapy will be interrupted Acti wh A ES Alerts and Alarms cont Canister Full Therapy Interrupted Alarm This alarm screen appears when the ActiV A C Therapy Unit detects that the canister is full and should be replaced WARNING If Canister is full replace and press Reset i i P If not full press Cancel Press for more information This alarm will be accompanied by a repeating audible tone This alarm may be silenced for two 2 minutes during troubleshooting by pressing Audio Pause To resolve this alarm 1 Check fluid level of canister by holding the therapy unit so thatthe Graduated Marks on the canister are level and parallel to the floor Graduated Marks A full canisteris approximately 300 ml 2 If canister is not full press Cancel 3 If canister is full change canister and press Reset on this screen to return to the Home Screen See the Canister Change section of this manual for additional information 4 Restart therapy by pressing WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours Alerts and Alarms cont Canister Not Engaged Alarm This alarm screen appears when the ActiV A C Therapy Unit Canister Not Engaged detects that the canister is not fully seated and properly latched WARNING Ensure canister is in place Press for more info
56. tient Mode allows the patient to have access to appropriate screen menus Therapy History Report A chronological log with date and times for therapy starts stops therapy settings alarm occurrences and canister dressing changes can be reviewed on screen or transferred from the ActiV A C Therapy Unit electronically in the form of a Therapy History Report This electronic transfer can be accomplished by accessing the Infrared Data Port or by inserting a USB flash memory stick into the USB Data Port No AC or battery powered drives computers computer equipment or other devices may be used Settings Guide V A C Therapy set up menus are available on screen to assist in the selection of therapy settings by wound type 1 The USB Data Port is to be used with non powered memory sticks and drives only The SensaT R A C System monitors and maintains target pressure at the wound site helping to deliver consistent therapy This system includes therapy unit hardware software wound exudate collection canister canister detection method multi lumen tubing connector and Sensat R C Pad In Line Canister Dressing Connectors The SensaT R A C System incorporates an in line dressing connector and tubing clamps to conveniently allow the wound dressing to be temporarily disconnected from the ActiV A C Therapy Unit in SensaT R A C System 300 ml Canister The ActiV A C Therapy Unit offers a single use latex free ster
57. tion of this manual if necessary Power the ActiV A C Therapy Unit On or Off Press and hold the Power On Off button for approximately 2 seconds to turn the ActiV A C Therapy Unit On or Off The Power On Off button is located immediately below and to the left of the Touch Screen User Interface The ActiV A C Therapy Unit will go througha self check routine and then presents a Warning Message screen Press OK to continue to this Clinician Mode Home screen shown below WwW ZO LO Q SMAC 3 Qy amp ED O Q Utilities Therapy a Clinician Mode Jun 22 2006 15 38 Therapy Accessing Manual Therapy Settings From the Clinician Mode Home screen press Therapy then Next to access the Therapy screen Therapy Settings iS _Guide _ Seal Check From the Therapy screen the clinician can access Settings Manually set therapy Seal Check Assists in finding leaks Settings Guide Guide for preset therapy settings History View or export therapy history Press Exit to return to the Clinician Home screen Settings 1 Settings changed manually take immediate effect when therapy is on From the Clinician Mode Home screen press Therapy then Next then Settings to access the Settings screen Settings E Pressure __ Intensity ne Continuous Intermittent gt gt From the
58. tive Sebi ey pressure at the wound may be below set pressure potentially interrupted Press For more information This alarm will be accompanied by a repeating audible tone This alarm may be silenced for two 2 minutes during troubleshooting by pressing Audio Pause To resolve this alarm 1 Ensure both clamps on the dressing and canister tubing are open 2 Ensure that the tubing is not kinked crimped or blocked in any way 3 Ifthe Low Pressure Alarm Therapy Interrupted remains after completing steps 1 and 2 lowering the therapy unit and tubing to be level with or below the wound site may resolve this alarm If the alert is cleared by lowering the unit normal use may resume 4 Press Reset on this screen to return to the Home Screen WARNING Therapy unit remains on however negative pressure at the wound may be below set pressure potentially compromising therapeutic benefits WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours _ If alarm condition cannot be resolved contact KCI See back cover of this User Manual for country specific contact information Acti Wh A Es Alerts and Alarms cont Therapy Inactive Alarm This alarm screen appears when the ActiV A C Therapy Unit has detected that V A C Therapy has been off for fifteen 15 minutes with the unit powered on without the Touch
59. ts Default setting is On Time 5 minutes Off Time 2 minutes Press Exit to return to the Settings screen Acti wh A E Settings cont Settings Confirmation Pressing GC finished with the Settings screen leads to this Confirm screen Confirm Pressure 125mmHg Mode Continuous Intensity Low If the displayed settings are as desired press OK to continue to the Clinician Mode Home screen Otherwise press Back to change any settings that are incorrect If settings were changed with V A C Therapy off press to start therapy Settings Guide The Settings Guide tool helps the clinician select from pre set therapy ranges according to wound type and treating physician s orders Selected ranges are a guide based on common settings for different wound types Individual patient conditions may vary Consult physician to verify settings for each patient Should physician orders fall outside the pre set therapy ranges select Other in this mode or use Manual Therapy Settings detailed earlier in the Clinician section of this manual From the Clinician Mode Home screen press Therapy then Next then Settings Guide and then OK to accessthis screen Select Wound Partial Thickness Burns tn buttons to select from the available wound type selections cD Use the Press Next when finished with this screen Settin
60. wound edges together reducing edema promoting granulation tissue formation and perfusion and by removing wound fluids and infectious material It is a flexible therapy in that with appropriate precautions in place may be used in most instances in both hospital and community settings This advanced wound healing technology coupled with microprocessor controlled therapy units and first class technical back up helps provide peace of mind for both clinicians and patients The V A C family of devices is used to help promote wound healing through multiple mechanisms of action under the influence of continuous and or intermittent negative pressure in association with wound site feedback control SensaT R A C technology The ActiV A C Therapy System is a Vacuum Assisted Closure System that provides Negative Pressure Wound Therapy NPWT and Therapeutic Regulated Acute Care SensaT R A C for use on a variety of chronic and acute wound types V A C Therapy is prescribed by a physician or other licensed prescriber The therapy should only be administered by a medical practitioner Patients should not 1 attempt to perform a change of settings and or therapy application without the express permission of the treating physician and or under the supervision of a trained clinical caregiver Important product and therapy indications contraindications precautions and safety information apply Please consult your clinician the acc

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