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1. 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 this screen From this Settings screen the clinician can Settings Pressure Intensity Continuous 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 Acti Wi C Settings cont Pressure Settings C1 Settings changed manually take immediate effect when therapy is on From the Clinician Mode Home screen press Therapy then Next then Settings then Pressure 125 mmHg a Pressure to access this screen Use the A Pressure can be set from 25 to 200 mmHg in increments of 25 mmHg buttons to change the desired pressure Press Exit to return to the Settings screen Default setting is 125 mmHg Intensity Control O Settings changed manually take immediate effect when therapy is on From the Clinician Mode Home screen
2. Therapy Unit 300 mL Canister The ActiV A C therapy unit offers a single use latex free sterile 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 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 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 V A C Dressings A variety of V A C Dressings are available for use with the ActiV A C Therapy System e Acti wh ew ES Clinician Feature Identification ActiV A C Therapy Unit Touch Screen User Interface ACtiVA C Canister KCI Authorized Maintenance Access Only USB Data Port Clinician Use Only Power Connection Battery Charging Infrared Data Port Indicator Light PowerOn Off Button Clinician Use Only O The USB Data Port is to be used with non powered memory sticks and drives only
3. 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 Canister Latch Guide Canister Stabilization Bumpers Contact KCI if the Silicone Seals Canister Latch Guide or the Canister Stabilization Bumpers are damaged or missing 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 Wh AN 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 00 1 Stop V A C Therapy by pressing EY on the Touch Screen User Interface Do not turn power off to the ActiV A C Therapy Unit A O N Slide both tubing clamps toward the tubing connector See 4 picture 2 a 3 Tightly close both tubing clamps Several clicks should be heard See picture ol 4 Disconnect the dressing tubing from the canister tubing by 1 twisting the tubing connectors until the locking tabs are disengaged o Y le d 2 2 pulling the connector apart See picture A 5 Depress the Canister Latch Release See picture 6 Remove
4. From the Clinician Mode Home screen press Therapy then Next then Settings Guide and then OK to access this screen Select Wound DD o o z Y buttons to scroll through the available wound type selections Use the 5 Press Next when finished with this screen Settings Guide cont Select Pressure cane E mmHg Vo buttons to scroll through the pressure selections Use the 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 GIRO QQ Select Mode DD D S Use the A buttons to choose Continuous or Intermittent Therapy Press Next when finished with this screen e Acti Wh NM OC Settings Guide cont If Intermittent therapy was chosen on the previous screen this Intermittent screen will appear Intermittent On Time Off Time Minutes Minutes me y 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 O Settings take effect after
5. 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 e Orange bar graph indicates a significant leak Line on bar graph is the transition point from green to orange and vice versa e Green bar graph indicates that the ActiV A C 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 at tubing connections 1 Ensure connector between dressing tubing and canister tubing is properly locked 2 Ensure the canister is securely installed onto the therapy unit If the 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 SensaT R A C Pad The bar graph will lowerand the frequency of the audible tone if Seal Audio is on will decrease 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 5 When finished with the Seal Check Tool press on the
6. pushing the connectors together 1 ly and pa es ms d y 2 twisting the connectors until the 2 14b q locking tabs are fully engaged See picture I Open both tubing clamps See picture Gao 15 Wrap any excess tubing into a bundle and put the tubing into the Tubing Storage Pocket on the bottom of the Carrying Case See picture 59 Ensure there are no kinks or the tubing is not pinched as it is putin 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 5b 16 Picture shows the Carrying Case with 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 C Inserting The Therapy Unit Into The Carrying Case O Start with the empty case Hold the case open and with a canister attached th e dd Flap and the Touch Screen User Interface facing down slide the ActiV A C Therapy Unit into the case sonunu to slide the unit into the case After the ActiV A C Therapy Unit is completely in the until it fits case fold the Access Flap over the therapy unit gt Close the Center Zipper A Wrap any excess tubing into a b
7. OK is pressed Once the settings are chosen this Confirm screen will appear gt RO amp a Confirm Partial Thickness Burns Pressure 125 mmHg Mode Intermittent Intensity Low ES 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 Settings Guide Intensity default is low Intensity can only be changed using the Manual Therapy Settings Acti WS Me ES 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 Jun 22 2006 15 38 _ Continuous h Therapy Off fo a A MAY Start Ey Leak Rate X Seal Check Tool d High 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 negative pressure leaks e Seal Check features an audible tone that changes frequency as the rate of the leak changes Pressing the Seal Audio button will switch be
8. screen R Canister Replaced Press OK to log that the canister has been changed Will use the current time and date Es Press OK to log that the canister has been replaced 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 Acti Wi NN e Starting Therapy cont Press to access this Foam Pieces screen Foam Pieces Press OK to log number of foam pieces and time date Last recorded Y on 15 55 12 06 06 CI oO Information displayed represents the last logged entry Use the buttons to change the number of pieces of foam 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 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 Acti Wh OS View or Export Therapy History Therapy History is a chronological log of dates and times for unit functions that include
9. t anisole Canister ES 23 9 Position the ActiV A C Therapy Unit so that p o E the Canister Latch Release can be pressed a toward the 50ml graduation mark See picture 93 Press the Canister Latch Release and remove the canister from the therapy unit See pictures a and 6 Dispose of the canister according to O institution and local environmental regulations 10 Install the new canister onto the ActiV A C Therapy Unit by sliding the opening inthe canister over the Canister Latch Guide Do a y not twist or turn the canister as itis being installed See picture 103 Push the canister onto the therapy unit An audible click should be heard See picture 0 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 therapy unit Ensure that no part of the case is 1 between the canister and the ActiV A C Therapy Unit 12 Pull the Access Flap back over the canister and ActiV A C Therapy Unit so that the canister is covered by the case Access See pictures and 20 Flap Acti wl Mom 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
10. Mm ES 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 f f This alert will be accompanied by a single audible tone Press for more information 3 TO E 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 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 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 therapy d A is 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 RY 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
11. Seal Check screen to return to the Home screen 6 If necessary contact your clinician or KCI for assistance or further information Acti WAA C 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 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 with arechargeable battery 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 loc
12. crimped or blocked in any way 3 If the Blockage 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 alarm 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 Acti Wh ee ES Alerts and Alarms cont Low Pressure Alert This alert screen appears when the ActiV A C Therapy Unit has not Se a Ey reached the selected therapy set pressure The measured wound pressure is l low the set This alert will be accompanied by a single audible tone Below he 29 prossun 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 nor
13. 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 teaspoon 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
14. forces the display backlight to remain bright when the unit is properly connected to the ActiV A C Power Supply Default setting is Off Acti wh Mw ES Standard Precautions The following are the KCI recommended daily and weekly cleaning and infection control 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
15. lt 2 amp amp amp e 1 cea ss amp 4 26 Leak Alarm Therapy Interrupted eee OT Blockage Alert n amp amp e 8 e dle ms E S Bose amp amp 28 Blockage Alarm Therapy Interrupted 0 28 Low Pressure Alet 2 amp amp amp 2 2 amp amp amp amp w amp o 2 Low Pressure Alarm Therapy Interrupted 2 29 Therapy Inactive Alarm 4 6 amp amp mts amp we w BO System Error Therapy Interrupted Alarm eee 390 Service Timer Expired Alert ee ee ee 91 Acti wi om C 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 YN Continuou 2 EE 0 mmHg ic 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 screen 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 thi
16. number is Wound Type Number Wound Type History O Acute Traumatic ddimmlyy Time Event 1 2 Partial Thickness Burns PE E S i 12 06 06 15 48 Therapy On 3 Dehisced Wounds 12 06 06 15 54 Canister Changed 4 Meshed Grafts 12 06 06 15 55 Dressing Changed 4 12 06 06 22 23 Canister Full 5 Pressure Ulcers 12 06 06 22 23 Therapy Off i 12 06 06 22 27 Therapy On 6 Chronic U Icers 12 06 06 22 29 Auto Therapy Off Leak 7 Flaps 12 06 06 22 32 Therapy On 8 Other Use the A buttons to scroll through the Therapy History Report Holding these buttons S will rapidly scroll through the Therapy History Report Press Exit to return to the Therapy History screen Acti Wi C 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 from a KCI product 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 Si srt to USB Export IR Data is exported with unit serial number but without patient identifier The U
17. particular procedure returns to the previous screen of that particular procedure ES acknowledges the action is complete and displays the next screen A V Holding these buttons will rapidly scroll through available selections e Acti WW SAC Clinician Operating Instructions O The ActiV A C Therapy Unit should be delivered to a new patient placement 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 section 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 Refer to the Clinician 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 this Clinician Mode Home screen shown below Clinician Mode Jun 22 2006 15 3 __ Continuous _ Therapy Off 0 mmHg Acti WAA C Therapy Accessing Manual Therapy Settings From the Clinician Mode Home screen press Therapy then Next to access this screen From this Therapy screen the clinician can access Therapy
18. 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 It is 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 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 tenet Default setting is Low Acti Wh Mm C 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 Settings B nE The words Continuous DE or Intermittent will appear in this area as modes are switched mode 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 Clinic
19. up 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 ActiV A C Therapy System Key Features Adjustable Negative Pressure Settings and Therapy Modes Settings can be selected from a range of 25 mmHg to 200 mmHg in increments of 25 mmHg In addition the therapy mode can be set for continuous negative pressure or intermittent negative pressure Seal Check Tool This tool assists the user in finding negative pressure leaks in the SensaT R A C System and V A C Dressing through the use of audible tones and on screen visual aids during the troubleshooting process Patient Mode Control Selection of Patient Mode by the clinician can help prevent unauthorized access to therapy set up screens Patient 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 ele
20. 9 3 x 15 2 x 6 4 cm 2 4 Ibs 1 08 kg 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 33A lt 100 Microamps 4 F 20 C to 140 F 60 C 0 95 non condensing 41 F 5 C to 104 F 40 C 0 95 non condensing 0 to 14 000 feet 0 to 4267 m 0 to 8 000 feet 0 to 2438 m Equipment not suitable for use in presence of flammable anesthetic mixture with air oxygen or nitrous oxide Type B Applied Part Class II IPXO Specifications subject to change without notice Acti Wi ES Therapy System Customer Contact Information KCI USA Inc San Antonio Texas 78219 T free 1800 275 4524 F free 1800 275 3417 www kci1 com K E or 46 www activac com gt oil The Clinical Advantage cus 5KA5 340075 Rev D September 2007
21. Acti Wh A E Therapy System User Manual The Clinical Advantage September 2007 340075 Rev D A WARNING Important Safety Information accompanies this device Indications Contraindications Warnings Precautions and other Safety Information are contained in the V A C Therapy System Safety Information Sheet This sheet andthe ActiV A C Quick Reference Guide are located in a pocket on the inside of the Front Flap of the Carrying Case To reduce risk of serious or fatal injury all caregivers 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 V A C Therapy Safety Information can be found on the internet at www activac com or www kci1 com Acti wh A ES Table of Contents Patient Mode Important Safety Information Statement Inside Front Cover Important Safeguards ww ee ee eB ActiV A C Therapy System Overview 4 Patient Introduction ko T Patient Feature Identification a ao of oe we ae a af o a Oh mt ee Patient Home Screen IT A A Oe as Da O Common Screen Control Buttons 9 Navigation Buttons 9 Patient Operating Instruct
22. C 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 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 gle respect to Electrical Shock Fire cus 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 5KA5 Medical Equipment classified with ISR respect to Electrical Shock Fire Gus 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 Dimensions Weight with empty canister attached Pressure Options Therapy Delivery Modes Canister Volume Electrical Battery Run Life Battery Charge Time External Power Supply Input External Power Supply Output Patient amp 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 Wi Mm OS Specifications 7 6 W x Hx 2 5 D 1
23. Mode has no patient operating screens Patients should not proceed unless authorized by caregiver Help Menu Instructions t Information Manufacturer Information For additional information concerning the ActiV A C Therapy System contact your local KCI Representative or KCI The Clinical Advantage Manufacturer KCI USA INC San Antonio Texas 78219 USA 1 800 275 4524 www kci1 com All trademarks and service marks designated herein are property of KCI Licensing Inc its affiliates and licensors This product is patented and or subject to pending patent oil cus 5KA5 2007 KCI Licensing Inc All Rights Reserved e Acti wi em ES Explanation of Symbols Used COPs BEERS n Z E i 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 Use Keep Dry Tripping Hazard No Bathing or Showering Power On Off Serial Number Date of Manufacture Manufacturer Approximate symbol Temperature Limits Symbol Authorized Representative in the European Community Not protected against harmful IPXO effects of water EF Alternating Current Direct Current 0 Class II Type B Applied Part Conforms with the Waste Electrical and Electronic Equipment Directive 2002 96 E
24. No AC or battery powered drives computers computer equipment or other devices may be used Clinician Mode Home screen inician Mode __ Mode Indicator Therapy On Off AMA 10 222008 Current Date Button Current Time Therapy Status Bar and Display Area Continuous Help Button Therapy Off fol a Screen Guard o 0 mmHg NA 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 Clinician Mode Home screen cont ED A green lighted crescent ED An unlit crescent means the function is on means the function is off ono starts or stops V A C Therapy lt gt accesses Region Settings and Time Date access buttons Screen Brightness and AC Light buttons tpn Settings Seal Check Tool Settings Guide and History access uttons 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 screen changes This feature should be used when cleaning the Touch Screen User Interface 1 Screen Guard is not a patient lock out feature Navigation Buttons One or more of these buttons may appear on a screen leaves that particular screen stops action in progress GQ goes on to the next screen of that
25. SB 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 to power the unit off and then on Retry exporting Therapy History e Ifthe above steps do not resolve the problem contact KCI for further assistance Infrared e Ensure that the Infrared Data Port on the receiving device is turned on and is in the receiving mode e Ensure that the two Infrared Data Ports are properly aligned pointed directly at each other and are within 3 feet 1 meter of each other e Ensure that the lenses of the Infrared Data Ports are clean not significantly scratched or damaged e Press OR power the unit off and then on Retry exporting Therapy History e Ifthe above steps do not resolve the problem contact KCI for further assistance Clinician Help Menu To ac
26. 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 button on the front of the unit 3 If error persists contact KCI See the back cover of this manual for contact information WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours Acti WAA C 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 When Days Left reaches 0 zero this alert will reappear 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 contact information 2 Press Enter Code to enter the code obtained from KCl Acti Wh Mm ES ActiV A C Frequently Asked Questions Q How much does the ActiV A C Therapy Unit weigh The ActiV A C Therapy Unit weighs 2 4 Ibs 1 08 kg with an empty canister installed battery last It takes approximately 6 hours to fully charge the battery The ActiV A C battery can maintain a cha
27. an two hours If alarm condition cannot be resolved contact KCI See back cover Acti Wh AA 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 Therapy Inactive minutes with the unit powered on without the Touch Screen WARNING Press Reset and Restart Therapy User Interface being touched 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 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 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 Alarm This alarm screen appears when there is a technical fault within the ActiV A C Therapy Unit a 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 This alarm will be
28. apy 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 German Spanish French Italian Dutch Swedish Danish Finnish Brazilian Portuguese and Turkish PO PD When should additional SensaT R A C Dressings and ActiV A C Canisters be ordered Additional supplies should be ordered when the patient is down to one case of dressings OR five canisters Orders may be placed by calling KCI s Advantage Center at 1 800 275 4524 at least 3 5 business days before the supplies are needed PO 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 for a fee from your KCI representative PO Acti wh A_C ActiV A C Frequently Asked Questions cont Q Can the ActiV A C Therapy System be used when undergoing diagnostic procedures A The chart below can be used to determine whether V A C Therapy can continue during specific procedures WARNING It is important to note that the ActiV A C Therapy Unit cannot be taken 1 into the Magnetic Resonance Imaging MRI suite or the Hyperbaric Oxygen Therapy HBO chamber See the V A C Therapy System Safety Information She
29. ard 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 ig Follow on screen instructions to unlock e Donot 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 KCl Avoid spilling liquid on any part of the ActiV A C Therapy Unit Liquids remaining on causing a potential hazard to patient or care providers 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 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 Clean
30. ation Charging Cord Connector AC Power Cord AC Wall Plug Acti wi Mm C Battery Charging Instructions cont Steps are numbered in order See picture on previous page D Plug the AC Power Cord into the DC Power Supply Brick 2 Plug the AC Wall Plug into an AC wall outlet 3 Locate the Arrow on the ActiV A C Charging Cord Connector 4 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 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 glow 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 bottom of the Touch Screen User Interface Fully Battery Battery Charged Low Critical Charge battery soon Charge battery immediately Acti Wh Me ES 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
31. cess the Clinician Help Menu the unit must be in Clinician Mode Changing to Patient or Clinician Mode Press 2 to access the Help Menu Help Menu Operating atient Operating Instructions Instructions Help Menu Contact Y Da 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 S Sy eo Patient Mode gt Clinician Mode c amp lt 0 stop QS For safe and effective therapy only pees ES aes as authorized caregivers should continue SY ae 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 Press Cancel to return to the respective Help Menu screen How to access On screen Operating Instructions and Changing Languages are in the Common Help Menu section of this manual Acti wh A ES Clinician Utilities From the Clinician Mode Home screen press Utilities to access this screen Utilities 7 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 display
32. ctronically 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 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 Clinician Introduction cont 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 Touch Screen User Interface The Touch Screen User Interface allows for easy navigation through operational and help menus A Screen Guard is available to help prevent unintentional changes Settings Guide V A C Therapy set up menus are available on screen to assist in the selection of therapy settings by wound type SensaT R A C System The SensaT R A C System monitors and maintains target pressure atthe 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 A 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
33. ed 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 x Set Time Date Year Month Day Hour 24 Minute nh El ll KE 9 Use the E buttons to set current time and calendar date F Holding these buttons will rapidly scroll through available selections Press Exit to return to the Utilities screen Acti Wi Me C Clinician Utilities cont Changing Pressure Units and Date Format From the Clinician Mode Home screen press Utilities then press Region Settings to access this screen Regional Settings mmHg kPa 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 i Briass brightness Default setting is High Brightness Low Changing AC Light Pressing AC Light
34. ent 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 Patient Mode Home screen shown below ve gt i Patient Mod acti Mito 2008 IDR a O Therapy Off fo e 0 mmHg starts or stops V A C Therapy Therapy On or Off 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 When the Audio Pause button is selected alerts that do not need immediate attention will be silenced for 60 minutes LX 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 Acti Wi amp C Patient Operating Instructions cont Finding a Leak Using Seal Check When the ActiV A C Therapy Unit detects a significant leak the Leak Alarm will activate See Alerts and Alarms section of this manual for more details on this alarm Press Seal Check or for more information Press ae on the Leak Alarm screen to use the Seal Check Toolto help find leaks The Seal Check
35. enu sM OY Ge eee ee ee eee 5B Changing Languages E OB On screen Operating Instructions SP SN Ue Oe Manufacturer Information 2 a a 2 ew ee ee ee 59 Explanation of SymbolsUsed 60 Specifications Y 2 2 ew ee ee ee ee ee 6 Customer Contact Information Back Cover Acti Wh ES Clinician Introduction 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 V A C Vacuum Assisted Closure Therapy is a system that uses controlled negative pressure vacuum to create an environment that promotes wound healing by secondary or tertiary delayed primary intention by preparing the wound bed for closure reducing edema promoting granulation tissue formation and perfusion and by removing exudate and infectious material This advanced wound healing therapy can be readily integrated into the clinician s wound healing practice helping to optimized patient care and manage costs 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 is coupled with microprocessor controlled therapy units and first class technical back
36. es 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 canister is approximately 300 mL 2 If canister is not full after checking level 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 Acti Wh Am ES Alerts and Alarms cont Canister Not Engaged Alarm This alarm screen appears when the ActiV A C Therapy Unit Canister Not Engaged detects the canister is not fully seated and properly latched WARNING Ensure canister is in place Press for more information E 0 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 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 unit s mat
37. et that accompanies the ActiV A C Therapy Unit located in the Front Flap pocket of the Carrying Case for specific instructions concerning MRI and HBO therapy WARNING Under clinician supervision replace V A C Dressing with alternate dressing if therapy is interrupted for more than two hours Therapy Unit Therapy Unit Diagnostic Procedures HBO X Ray Cat Scan CT Dye Tests Fluoroscopy Ultrasound If the V A C Dressing is left in place for the diagnostic procedures marked Therapy Unit A Compatible note there is a possibility of shadow casting in the area of the wound The decision to keep the V A C Dressing in place or not should be made by the radiologist radiology technician and or your 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 Acti wi em ES Clinician Mode Table of Contents 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 Important Safety Information Statement Inside Front Cover Important Safeguards Battery Charging Instructions 2 we eee 12 Battery Charging Indicator Light 2 0 18 Battery Charge Level Ind
38. f 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 e Acti wi ES Alerts and Alarms ATTENTION anditnieris and Alarms 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 attention in order to ensure the prescribed therapy is being delivered Alarms will be accompanied by a repeating audible tone Press Audio Pause to silence the audible tone for 2 minutes Press for more information If alarm conditions cannot be resolved contact KCI See back cover Index of Alerts and Alarms Battery Low Alert s ao 6 ww amp 28 Battery Critical Alarm o 2 oe we ce 6 4 amp 9 28 Canister Full Therapy Interrupted Alarm 0 0 4 Canister Not Engaged Alarm 58 2 5 25 Leak Alarm lt
39. he 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 Refer to the Standard Precautions section of this manual 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 Acti wh A ES Patient Feature Identification ActiV A C Therapy Unit Touch Screen User Interface ActiV A C Canister KCI Authorized Maintenance Access Only USB Data Port Clinician Use Only Power Connection Battery Charging Indicator Light Power On Off Button Infrared Data Port Clinician Use Only C1 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 Patient Home Screen Audio Pause Indicator with x s eds Mode Indicator Countdown Timer IS Current Date Current Time Therapy noi gt Cc ise Therapy Status Button Bar and Display ane we Area Continuous 2 Therapy Off 3 gt Screen Guard omis Help Button sE This plug indicator Battery Level Indicator appears while plugged into a wall outlet This icon rotates when the ActiV A C Therapy Unit is applying negative pressure Patient Home Scree
40. ian Mode Home screen press Therapy then press Settings then press Intermittent to access this screen Intermittent On Time Off Time Minutes Minutes ay y 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 O Default setting is On Time 5 minutes Off Time 2 minutes Press Exit to return to the Settings screen Acti Wh AA OC Settings cont Settings Confirmation Pressing when 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
41. icator eee 13 Canister Change ae ee ee ee ee es Identifying Canister and Related Parts po 6 es amp e amp wee 6 be 2 amp el Changing Canisters 2 amp e amp amp SAA se 2 2 a amp a WO Carrying Case Parts Identification oe ee oe ae oe oe Oe Canister Change in Carrying Case war AT Inserting The Therapy Unit Into The Carrying Case v A ao 20 Carrying Case Configurations sO A A wee 2 General Information About Alerts and Alarms lt wwe a 22 Index of Alerts and Alarms or eee ee ee 22 Frequently Asked Questions K ww ke ee ee ee 32 Clinician Mode Table of Contents 34 Clinician Introduction 2 ew ee ee eee 36 Clinician Feature Identification 38 Clinician Mode Home Screen eee 38 Common Screen Control Buttons eee 399 Navigation Buttons s 2 6 4 E e e ps a 46 539 Clinician Operating Instructions 6 Be es th amp amp we amp amp OO Power the ActiV A C Therapy Unit On or Off SA sy Las amp amp sa Accessing Manual eae id Sf oc 8 sea Wee we 8 e g o Settings oe fe BR amp Oh we ke we a 4 amp goa OE Pressure Settings a 0 o o o o 42 Intensity Control eo oo ee foe ee ee Oe Re Re Continuous and Intermittent Modes DS e e E E Fogo s mos a amp e Intermit
42. ing Audio Pause To resolve this alarm 1 Ensure connector between dressing tubing and canister tubing is properly locked 2 Ensure canister is fully engaged See Canister Not Engaged Alarm 3 Press EY to use the Seal Check Tool to help identify leaks in dressing Refer to the Finding a Leak Using Seal Check section of this manual for details on how to use Seal Check The patient s only access to the Seal Check Tool is through this Leak Alarm screen e 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 e Once the leak is resolved using the Seal Check Tool press on the Seal Check screen to return to the Home screen 4 Once the leak is resolved ensure that V A C Therapy is on by observing that the green crescent is lit on the 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 Refer to Leak Alarm Therapy Interrupted alarm section of this manual for procedures to restart therapy Acti Wh Me ES Alerts and Alarms cont 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 therapy has been interrupted WARNING Press For more informati
43. ing 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 witha diluted solution of 1 teaspoon bleach in 1 quart 5 milliliters bleach in 1 liter 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 Wh A C Common Help Menu Changing Languages Help Menu Press 2 to access the Help Menu dl Es Clinician Mode Operating Press the Globe upper left to access the Language screen buttons to select the desired language Use the Press when finished On screen Operating Instructions Press 2 to access the Help Menu Press Operating Instructions to access the Operating Instructions selection screen Help Menu E Operating Instructions 7 Contact Information Clinician From this Operating Instructions screen one can browse Operating Instructions E the various Help Screens that are available Choose from Operation Cleaning instructions and Alarms for alarm descriptions and suggested resolutions Press when finished Common Help Menu cont Clinician Mode Press to access the Help Menu Clinician
44. ing 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 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 alarm condition cannot be resolved contact KCI See back cover 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 Leak Alarm Flashing green oval lt A This alarm screen appears when the ActiV A C Therapy Unit Leak Alarm gt detects a significant negative pressure leak Press Seal Check or 2 for more information f this alarm is not resolved in three 3 minutes therapy will be interrupted This alarm will be accompanied by a repeating audible tone 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 This alarm may be silenced for two 2 minutes during troubleshooting by press
45. ions i mog a d oe Coke oa es oe e e O Power the ActiV A C ais Unit On c or of E Ss YS we E WW Therapy OnorOff fF om wees 4 ek Oe es a O Audio Pause e 2 8 ls 2A 2 ns ys 4910 Finding a Leak Using Seal Check 2 E y lOs sy ss de E Finding the Leak a aw nw we 11 Battery Charging Instructions LO N mo ew ee ee 12 Battery Charging Indicator Light gt E naO SOAR e ea a e a Battery Charge Level Indicator 2 0 22 ee 13 Canister Changes ee oe ew SOS A eh Ue a Identifying Canister and Related Parts ALAS a ke ee Oe e a a e a A Changing the Canister ee e E amp 2 oe amp sas sa Carrying Case Parts Identification Pe 2 lea d E es Se ese M1 Canister Change in Carrying Case 2 we ee 17 Inserting The Therapy Unit Into The Carrying Case 20 Carrying Case Configurations 0 we ee ee 221 Alerts and Alarms zogo h b g goo n E Important Information About Alerts and Alarms so e ee owe G o a a es a e a Index of Alerts and Alarms 2Z Frequently Asked Questions a a a 392 Clinician Mode Table of Contents a ew ew ee A Standard Precautions a ee 56 Care and Cleaning 2 o T Common Help Menu a ee 5B Changing Languages 2 eS ee eB es es ee oe et a ge oe s Be On screen Operating Instructions se 6 Sk of we 2 amp 6 a o a
46. lap with Hook and Loop Fastener Acti WWW SAC Canister Change in carrying Case Front aS 1 Open the Front Flap on the Carrying Case See picture CD 1 V A C Therapy is already off if addressing a Canister Full Alarm Stop V A C Therapy by pressing EY on the Touch Screen User Interface See picture Do not turn power off to the ActiV A C Therapy Unit lt 2 Slide both tubing clamps toward the tubing connector See x picture 2 3 Tightly close both tubing clamps Several clicks should be heard See picture 3 pne 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 back of the case Undo the Hook and Loop Fastener on the Access Flap and fold the Access Flap back to begin to expose the canister See picture Acti Wh AA ES Canister Change in Carrying Case cont 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
47. mal use may resume 4 Press Exit to return to the Home screen 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 negative eee pressure at the wound may be below set pressure potentially compromising therapeutic benefits WARNING Unit may be running but therapy is 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 If the 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 th
48. mp wwe Continued on next page Acti Wh C Table of Contents Patient Mode cont Manufacturer Information 59 Explanation of Symbols Used 60 Specifications 61 Back Cover Customer Contact Information Acti Wh AA C 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 and the ActiV A C Quick Reference Guide are located in a pocket on the inside of the Front Flap of the Carrying Case If the V A C Therapy Safety Information Sheet or Quick Reference Guide are missing immediately contact KCI for a replacement Refer to 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 It is recommended that the ActiV A C Therapy Unit always be kept in the Carrying Case when in use e The ActiV 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 wi
49. n cont ED A green lighted crescent ED An unlit crescent means the function is on means the function is off Onl starts or stops V A C Therapy 5 3 When the Audio Pause button is selected alerts that do not need immediate attention will be 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 screen EN changes This feature should be used when cleaning the Touch Screen User Interface To release Screen Guard press 1 and then 2 Navigation Buttons One or more of these buttons may appear on a screen leaves that particular screen Cancel stops action in progress QQ goes to the next screen of that particular procedure returns to the previous screen of that particular procedure acknowledges the action is complete and displays the next screen e Acti WWA C 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 Pati
50. on 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 Press Reset on this screen to return to the Home Screen 2 Restart therapy by pressing E For Patients Only 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 O For Clinicians Onl If the leak condition was not resolved the ActiV A C Therapy Unit provides several pathways for the Clinician to access the Seal Check Tool for further troubleshooting Refer to the Clinician section of this manual for details 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 Acti Wh
51. 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 activities that are likely to generate splashes or sprays of blood body fluids secretions and excretions Acti wh me C 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 Disc
52. pe meets the skin e where the SensaT R A C Pad is attached to the drape e at tubing 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 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 SensaT R A C Pad The bar graph will lower and the frequency of the audible tone if Seal Audio is on will decrease 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 Acti Wh fm C Starting Therapy cont Log Tool Overview e Log Tool can be used to track the number of foam pieces used during a dressing change e Log Tool can be used to track canister changes e Logged information is viewable and exportable on the Therapy History screens How to Use Log Tool When Starting Therapy Item to Log For Dressing also note t pieces in patient chart O offoam ae Press Exit to return to the Clinician Mode Home screen Press to access this Canister Replaced
53. pilling fluids on any part of the ActiV A C Therapy Unit A e f 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 0 Do not use ActiV A C Therapy Unit while bathing showering or where it can fall or be pulled CS 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 We Mm OS ActiV A C Therapy System Overview Specific features are detailed in the Patient Feature Identification section of this manual zac a A a E ee Canister Tubing Clamp yr Canister Tubing Connector Canister Tubing Power On Off Canister Latch Release ActiV A C Canister ActiV A C Therapy Unit Typical V A C Dressing Not included with therapy unit SensaT R A C Pad Tubing dressing AN i SensaT R A C Pad z A V A C Drape 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 WAA C ActiV A C Therapy System Overview ActiV A C Po
54. rge up to 14 hours A Q How long does it take to charge the battery and how long will a fully charged A po The ActiV A C Therapy Unit is sometimes noisy Why is this and what can I do about it The ActiV A C Therapy Unit may make noises to enable the accurate delivery of negative pressure to the wound Placing the therapy unit below the level of the wound may allow the system to work more efficiently and more quietly It is within normal operation to note on again off again noise from the ActiV A C Therapy Unit The ActiV A C Therapy Unit may also be very quiet at times 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 PO Q What if do not hear an audible click when installing a canister onto the ActiV A C Therapy Unit An audible click should be heard when installing anew 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 from the unit gt Is the ActiV A C Canister compatible with all V A C Therapy Units No the 300 mL canister is to be used only with the ActiV A C Ther
55. rty 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 Ensure therapy is on by confirming that the green crescent is lit on the button If not press to restart therapy oO 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 30 minutes therapy will be interrupted Acti WAA OS Alerts and Alarms cont Canister Full Therapy Interrupted Alarm canbe This alarm screen appears when the ActiV A C Therapy Unit Pa detects that the canister is full and should be replaced Paul iull press Cancel Prone for mom ntormeton This alarm will be accompanied by a repeating audible tone This alarm may be silenced for two 2 minut
56. tent Settings 2 2 2 6 we 43 Settings Confirmation 2 2 2 MA Settings Guide Cee oe se oe Fk ee eS ee we a Settings Guide Confirmation Ses ee es Aw E amp a EO Acti WW Lu o Clinician Mode Table of Contents cont Starting Therapy amp ee amp E He S amp S amp HS amp ST Seal Check Overview aoe G p a Dog o d e Ar How to Use Seal Check When Starting Therapy rnc Finding the Leak Using Seal Check i e a ee es amp oe Log Tool Overview of ee amp oe ee me Celle Uw 1 How to Use Log Tool When Starting Therapy Ste se um e amp wo a a 49 View or Export Therapy History aa 51 View Therapy History s 2 amp amp amp amp amp E pod i g s amp 9l Export Therapy History Report 2 4 O Troubleshooting USB or Infrared Export Problems i a amp amp Ft amp amp amp amp amp Be Clinician Help Menu A E a ee a OS ae Changing to Patient or Clinician Mode Co wo we uw re go Ah oh amp amp e foe Clinician Utilities A A ee ee Changing Time and Date oa I o oa s AOA e o ooa amp x e OA Changing Pressure Units and Date Format A e OU oa ee OO Changing Screen Brightness aaa DD Changing AC Light 6 2 2 6 gt o ssc 2 e mm e E BS Standard Precautions wee ee ee ee 8G Care and Cleaning Q gt AD D we ew ew eel CT Common Help M
57. th 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 manual 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 adamaged 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 Never drop or insert any object into any opening or tubing of the ActiV A C Therapy System e Do 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 to fail Component failures may cause the unit to operate D Liquids remaining on the electronic controls can cause corrosion that may cause the erratically possibly producing potential hazards to patient and staff e Avoid s
58. 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 AA ES 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 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 a engaged See picture 9 9 ZA i 10 Open both tubing clamps See picture a 11 Press on the Touch Screen User Interface to restart V A C Therapy Verify the dressing compresses Carrying Case Parts Identification rear view Flap covering Multi function Hook Center Zipper with Covering Flap Buckles Vv shown connected Tubing Storage Pocket with Zipper and Covering Flap Built in Belt Loop underneath Access F
59. tween the audible tone being on or off e Seal Check also features a real time bar graph that gives a visual indication of the rate of the leak The Seal Check Tool appears three 3 different ways e When therapy is started from the Clinician Mode Home screen discussed on the following pages e When the Seal Check button is pressed from the Therapy screen e 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 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 a a 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 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 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 O green state if there are no significant leaks Most leaks occur O e where the dra
60. undle 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 The case can be worn over the shoulder with the strap adjusted for comfort ta 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 Carrying Case Configurations The case can be worn over the opposite 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 o
61. unit power on off therapy starts stops and unit inactivity that exceeds 15 minutes when unit power is on Therapy selections made manually or using the Settings Guide tool Alarm occurrences that interrupt therapy Canister and dressing changes are recorded when manually logged using the Log tool The report 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 screen press Therapy then Next then History to access this Therapy History screen 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 used instead The logic for this order is On the Settings Guide Select Wound Type selection screen if you press the minus to access the first wound type it will start on Acute Traumatic Wound Type 1 Then with each push of the plus button you will change wound type according to the ordered list below with the corresponding wound type on the Therapy History Report screen shown below Because of space limitations the Therapy History Report does not spell out Wound Types A
62. wer Supply Components ActiV A C Charging Cord ActiV A C Carrying Case y AC Power Cord DC Power Supply Brick and Adjustable Strap Storage Pocket for the ActiV A C Quick Reference Guide and the V A C Therapy System Safety Information Sheet Ensure that the ActiV A C Quick User Manual The Clinical Advantage Acti We em C Therapy System Reference Guide and V A C Therapy System Safety Information Sheet are in the Carrying Case pocket at all times V A C Therapy ActiV A C Safety Information Sheet Quick Reference Guide INSTRUCTIONS FOR USE Acti a A C ENGLISH z x Therapy System Quick Reference Guide Y SYSTEM SAFETY INFORMATION of the V A C Vacuum Assisted Closure ing the foam dressing e VAA C GranuFoam directions from or supervision by the clinical caregiver INDICATIONS FOR USE SKCI The Clinical Advantage For Patient Use September 2007 S0075 Rev D Acti wh em C S DA o Se This page left nena Pink O OX O a ES Acti AAA ES Patient 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 wound edges together reducing edema promoting granulation tissue formation and perfusion and by removing
63. wound fluids and infectious material V A C Therapy is prescribed by a physician or other licensed prescriber As with any prescription medical device it is important to follow physician s orders and product instructions and not adjust settings or perform therapy application without the express direction and or supervision of a trained clinical caregiver Important product and therapy indications contraindications precautions and safety information apply Please consult your clinician the accompanying V A C C1 Therapy System Safety Information Sheet 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 Guard is available to help prevent unintentional changes On screen User Guide Easy to use Operating Instructions are available on screen Battery Operation In order to facilitate mobility and a 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 Seal Check Tool This tool assists in finding negative pressure leaks in the SensaT R A C System and dressing through the use of audible tones and on screen visual aids during t

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