M6252250C InfoVAC User Manual
Contents
1. This alarm screen appears when the canister is full and should be replaced This alarm will be accompanied by a repeating audible tone Press Audio Pause to silence the audible tone for two y Audio Pause ffe e o To resolve this alarm WARNING If Canister is full replace and press Reset If not full press Cancel Press for more information i 1 Check fluid level of canister by holding the therapy unit so that the Audio Pause Reset graduated marks on the canister are level and parallel to the floor Qu gt Ka lt a K A full canister is approximately 300 mL y ie D 3 If canister is full change canister and press Reset to e return to the Patient Mode home screen See the a Canister chapter of this manual page 10 for 4 additional information A Restart therapy by pressing the Therapy On Off On Off button Graduated Marks ED 2 If canister is not full after checking level press Cancel WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours To avoid a false alarm keep the therapy unit as upright as possible The touch screen should be in a readable right side up orientation or facing up when the unit is laid on a level surface 20 Canister Not Engaged Alarm This alarm screen appears when the canister is not fully seated and not properly latched T2. User Manual For Patients and Clinicians 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 information sheet is included with the therapy unit and also included in V A C Dressing cartons Please consult the V A C Therapy System s User Manual and the Safety Information Sheet before applying V A C Therapy If there are questions or if this information sheet is missing immediately contact your local KC representative gt Ka Additional product information can be found at www kcil com USA or www kci medical com outside the USA 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 In case of medical emergency immediately contact your local emergency services provider CAUTION Federal law US restricts this device to sale or rental by or on the order of a physician DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY KCI HEREBY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABI
3. 2 lower the therapy unit and tubing to level with or below the wound site If the alert is resolved by lowering the unit normal use may resume gt 4 Press Reset to return to the Patient Mode home screen If alarm condition cannot be resolved contact your caregiver or KCI representative WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours 24 Low Pressure Alert This alert screen appears when the selected therapy set pressure has not been reached This alert will be accompanied by a single audible tone V A C Therapy is still being applied but at a lower than selected pressure O To resolve this alert 1 Ensure both clamps on the dressing and canister tubing are open y S rr Zz The measured wound pressure is 5 below the set pressure 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 Press for more information lower the therapy unit and tubing to level with or below the wound site If the alert is resolved by lowering the unit normal use may resume L ea 4 Press Exit to return to the Patient Mode home screen Low Pressure Alarm Therapy Interrupted This alarm screen appears when the selected therapy set pressure has not been reached and negative pressure at the wound may be below set pressure This alarm
4. Display Area TherapyO n Off Button This icon rotates when the 7 s A Battery Level Indicator ActiV A C Therapy Unit is p ga ee y applying negative pressure Continuous E Help Button 3 Therapy Off wa Screen Guard N r OmmHg v D A lighted green crescent means Ea An unlit crescent means the function is on the function is off Common Screen Control Buttons Most screens have one or more common control buttons These are Q Access Help screens when available Activate the Screen Guard feature to help prevent unintentional changes This feature should be used when cleaning the touch screen To release Screen Guard press 1 and then 2 u gt Ka Navigation Buttons One or more of these buttons may appear on a screen Leave the current screen Stop action in progress Go to the next screen Return to the previous screen Acknowledge the action is complete and display the next screen Audio Pause Press Audio Pause to silence for 60 minutes alerts that do not need immediate attention Audio Pause AA A Countdown Timer and Audio Pause Indicator will be displayed in the upper left corner of the screen 5 8 23 Alarms needing immediate attention override the Audio Pause feature See the Alerts and Alarms chapter of this manual page 18 for details on alarms and how to resolve them Battery Charging Instructions The ActiV A C Therapy Unit comes with a
5. Inc Medical Equipment classified with respect to Electrical Shock Fire and Mechanical Hazards Only in accordance with UL 60601 1 Standards including JIS amendment by Underwriters Laboratory Inc O E C gt Z 39 Z lt Z y Specifications PN NS OUI en ye q A 1 6 Wx6 Hx2 5 D 19 3 x 15 2 x 6 4 cm Weig t with empty canister attached EE 2 4 lbs 1 08 kg Weg EE 25 to 200 mmHg 3 3 to 26 6 kPa Therapy Deliver EE Continuous or Intermittent EE VOU E 300 mL Electrical O EE 14 hours depending on settings Eat o TTT 6 hours from a fully discharged state External Power SUPPI AMO EE 100 240VAC 72A 115VAC 47 63 Hz Sa Ene e e EQU E 12V 3 3 A Patient amp Enclosure Leakage CUNEN GE lt 100 Microamps Environmental Conditions Storage Conditions Temper ure n E 4 F 20 C to 140 F 60 C Relative Humidity Range EE 0 95 non condensing Operating Conditions Elo as MAA A ok es eto a E EA A A 41 F 5 C to 104 F 40 C Relative o A PP 0 95 non condensing A EEN O to 14 000 feet 0 to 4267 m Opium y Tee ee EE O to 8 000 feet 0 to 2438 m IEC Classification Medical Equipment Equipment not suitable for use in presence of flammable anesthetic mixture with air oxygen or nitrous oxide Type B Applied Part Class Il IPXO Specifications subject to change without notice 60 Customer Contact Information For questions regarding this product supplies maintenance
6. and off L e Press Exit to return to the Clinician Home screen Change Time and Date From the Clinician Mode Home screen press Utilities then Time Date to access this screen Use the and buttons to set current time and calendar date Year Month Day Hour 24 Minute l Hold the and buttons to rapidly scroll through Set Time Date LT ES El EN E 26 Press Exit to return to the Utilities screen N lt 2 D Z 9 Change Pressure Units and Date Format The ActiV A C Therapy Unit is designed to show two units of measure with mmHg millimeters of mercury a the default If you prefer kPa kilopascals follow the directions in this section to change the Pressure Unit l From the Clinician Mode home screen press Utilities then Region Regional Settings L pa Settings to access the Regional Settings screen S Unit mmHg O Default settings are mmHg and MM DD YY SS E A l l Press Pressure Unit to switch between mmHg millimeters DEA UE MM DD YY UE aT mercury and kPa kilo pascals units of measurement Press Date Format to switch between DD MM YY Day Month Year and MM DD YY Month Day Year formats ODA L en Press Exit to return to the Utilities screen Date Format Change Screen Brightness O Press Brightness to switch between three levels of screen brightness High D i E Time Date eme Brightness Medium een Utilities Reg
7. or additional information about KCI products and services please contact KCI or a KCI authorized representative or In the US call 1 800 275 4524 or visit www kcil com Outside the US visit www kci medical com N lt 2 gt Z 61 NANO 62 activac KCI Healing by design KCI USA Inc KCI Medical Products UK Ltd San Antonio Texas 78219 USA EC REP Wimborne Dorset www kci1 com BH21 7SH United Kingdom www kci medical com w All trademarks designated herein are property of KCI Licensing Inc its affiliates and licensors 2011 KCI Licensing Inc All Rights Reserved 340399 Rev B 3 2011
8. rechargeable 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 Use only the power supply provided with the ActiV A C Therapy Unit Using O any other power supply may damage the therapy unit Ka G lt a If environmental conditions specifically low humidity pose a risk of static electricity take care when handling the therapy unit while 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 to darken or the therapy unit to reset or turn off If therapy does not restart by powering the unit off and then on immediately contact KCI WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours A Power cords may present a tripping hazard Ensure that all cords are out of areas where people may walk Battery Level Indicator Battery Charging Indicator Light Plug to DC Power Supply Charging Cord Connector AC Power Cord h a AC Wall Pig To charge the battery 1 Plug the AC power cord into the DC power supply 2 Plug the AC wall plug into an AC wall outlet 3 Locate the arrow on the charging cord connector 4 Place therapy unit and chargin
9. required the Battery Charging Instructions chapter of this manual page 8 for more information y S TT Zz 2 Press Exit to return to the Patient Mode home screen C V A C Therapy continues VN Continuous Oo Q OmmHg OF Battery Critical Alarm This alarm screen appears approximately 30 minutes before the battery power runs out This alarm will be accompanied by a repeating audible tone lt a Press Audio Pause to silence the audible tone for two Audio Pause Battery Critical oo To resolve this alarm Battery critically low charge immediately 1 Connect the therapy unit to a wall outlet using the ActiV A C Audio Pause Reset Power Supply to recharge battery The light next to the bottom left SS NA of the touch screen will glow amber as the battery charges Refer to a Ea the Battery Charging Instructions chapter of this manual page 8 for more information Press Reset to return to the Patient Mode home screen Ensure therapy is on by confirming that the green crescent is lit on the Therapy On Off button If not press the Therapy On Off button to restart therapy V A C Therapy continues however if this alarm is not resolved within 30 minutes therapy will turn off WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours Canister Full Therapy Interrupted Alarm
10. securely installed on the therapy unit If the canister is properly installed it cannot be removed by gently pulling it 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 L ea 5 When finished press Exit to return to the Clinician Mode home screen Log Tool The Log Tool can be used to track e the number of foam pieces used during a dressing change e canister changes Logged information can be viewed and exported from the Therapy History screens How to Use the Log Tool When Starting Therapy a Dress Log on the Therapy Start screen to access the tem to Item to Log L ea O Log screen Choose Canister or Dressing Canister Dressing Press Exit to return to the Clinician Mode home screen For Dressing also note the No of foam pieces in patient chart and on drape Z lt 2 y y 48 How to Use the Log Tool When Starting Therapy cont l Press Canister to access the Canister Replaced screen Canister Replaced Cancel Press OK to log that the canister has been replaced and Press OK to log that the Lo r
11. shower with dressings in place Care should be taken not to roll the edges of the drape while bathing Refer to the Therapy Unit Disconnect chapter of this manual page 14 for more information 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 Therapy Unit and InfoV A C Therapy Unit 32 PO PR What languages are available in the ActiV A C Therapy Unit The therapy unit is pre programmed with the following languages English German Spanish French Italian Dutch Swedish Danish Finnish Brazilian Portuguese and Turkish When should additional SensaT R A C Dressings and ActiV A C Canisters be ordered Order additional supplies when you have only one case of dressings OR five canisters left Orders may be placed by calling KCI at least 3 5 business days before the supplies are needed gt mi Z Are there any recommendations to note when traveling Consult your healthcare provider prior to traveling to determine if it is safe for you to travel Do not travel without first obtaining medical approval and a complete understanding of all of the risks that may pertain to your medical condition as well as to V A C Therapy Risk of bleeding during travel can have serious and potentially fatal consequences Once medical approval is obtained it is recommended that you have the following items with you during travel e
12. Case Options The ActiV A C carrying case has an integrated belt loop and a separate adjustable strap to allow for versatile carrying options gt Ka When worn or carried ensure that the buckles are properly snapped together Keep the ActiV A C Therapy Unit in the upright position The touch screen should be in a readable right side up orientation or facing up when the therapy unit is laid on a level surface It is recommended that the ActiV A C Therapy Unit always be kept in the carrying case when in use Ka G a Therapy Unit Disconnect time for such activities as bathing WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours O The therapy unit may be disconnected from dressing tubing for short periods of D 1 Stop therapy by pressing the Therapy On Off button on the touch screen 2 Turn power off to the ActiV A C Therapy Unit and uplug it from the electrical outlet Slide both tubing clamps toward the tubing connector Tightly close both tubing clamps to prevent spillage of contents in tubing Several clicks should be heard Fig 1 Compress and then twist the tubing connectors until the locking tabs are disengaged and pull the connector apart to disconnect the dressing tubing from the canister tubing Fig 2a and 2b Cover tubing ends with gauze to collect any spillage fro
13. LITY OR FITNESS FOR A PARTICULAR PURPOSE ON THE KCI PRODUCT S DESCRIBED IN THIS PUBLICATION ANY WRITTEN WARRANTY OFFERED BY KCI SHALL BE EXPRESSLY SET FORTH IN THIS PUBLICATION OR INCLUDED WITH THE PRODUCT UNDER NO CIRCUMSTANCES SHALL KCI BE LIABLE FOR ANY INDIRECT INCIDENTAL OR CONSEQUENTIAL DAMAGES AND EXPENSES INCLUDING DAMAGES OR INJURY TO PERSON OR PROPERTY DUE IN WHOLE OR IN PART TO THE USE OF THE PRODUCT OTHER THAN THOSE FOR WHICH DISCLAIMER OF WARRANTY OR LIMITATION OF LIABILITY IS EXPRESSLY PROHIBITED BY SPECIFIC APPLICABLE LAW NO PERSON HAS THE AUTHORITY TO BIND KCI TO ANY REPRESENTATION OR WARRANTY EXCEPT AS SPECIFICALLY SET FORTH IN THIS PARAGRAPH Descriptions or specifications in KCI printed matter including this publication are meant solely to generally describe the product at the time of manufacture and do not constitute any express warranties except as set forth in the written limited warranty included with this product Information in this publication may be subject to change at any time Contact KCI for updates Important Information For Users In order for KCI products to perform properly KCI recommends the following conditions Failure to comply with these conditions will void any applicable warranties e Use this product only in accordance with this manual and applicable product labeling e Assembly operations extensions re adjustments modifications technical maintenance or repairs must be performed by qu
14. Your prescription for V A C Therapy which includes therapy settings and dressing supplies e Enough V A C System components such as foam drape tubing and canisters for dressing and canister changes at the recommended time intervals or as needed e Dressing changes should be performed no less than three times a week e Canisters should be changed when full or at least once a week e An alternate dressing recommended by your health care practioner to be used in the event V A C Therapy needs to be discontinued e A fully charged therapy unit and power cord e The ActiV A C Therapy Unit User Manual and QRG WARNING According to clinician instructions replace VA CX Dressing with alternate dressing if therapy is interrupted or off for more than two hours ER Ka G lt a Q Can the ActiV A C Therapy System be used during diagnostic procedures A Use the chart below to determine whether V A C Therapy can continue during specific procedures Diagnostic Therapy Unit Therapy Unit Dressing Dressing Procedures Compatible NOT Compatible Compatible NOT Compatible MRI X X X Ray X X Cat scann O E O O Dye Tests X X Ultrasound X X WARNING The ActiV A C Therapy Unit MUST NOT be taken into a Magnetic 1 Resonance Imaging MRI suite or Hyperbaric Oxygen Therapy HBO chamber See the V A C Therapy System Safety Information Sheet that accompanies the ActiV A C Therapy Unit located in the front fla
15. alified personnel authorized by KCI Ka G a e Ensure the electrical installation of the room complies with the appropriate national electrical wiring standards e Do not operate this product if it has a damaged power cord power supply or plug If these components are worn or damaged contact KCI e Do not drop or insert any object into any opening or tubing of this product e Do not connect this product or its components to devices not recommended by KCI e Use only V A C Dressings with this product e Keep this product away from heated surfaces e Although this product 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 e Avoid spilling fluids on any part of this product Fluids remaining on the electronic controls can cause corrosion that may cause 1 the electronic components to fail Component failures may cause the unit to operate erratically possibly producing potential hazards to patient and staff If spills do occur unplug the unit immediately and clean with an absorbent cloth Ensure there is no moisture in or near the power connection and power supply components before reconnecting power If the product does not work properly contact KCI e Do not use this product while bathing showering or where it can fall or be pulled into a tub shower o
16. anister over the canister latch guide Ensure the canister is installed directly onto the therapy unit Do not twist or turn the canister as it is being installed An audible click should be heard when canister is properly installed Ensure the canister is securely installed on the therapy unit If the canister is properly installed it cannot be removed by gently pulling it directly away from the unit Reconnect the new canister tubing to the dressing tubing by pushing the connectors together Compress and twist until the locking tabs are fully engaged Fig 5a and 5b Open both tubing clamps Fig 6 Press the Therapy On Off button on the touch screen to restart therapy Verify the dressing collapses Carrying Case Access Flap with Hook and Loop Fastener Ka G a Storage Pocket for the ActiV A C Therapy System Quick Reference Guide and the V A C Therapy System Safety Information Sheet Buckles shown connected Tubing Storage Straps Insert the ActiV A C Therapy Unit into the carrying case so that Integrated the touch screen is Belt Loop visible through the underneath cut out window should be in a readable right side up orientation or facing up when the i Keep the ActiV A C Therapy Unit in the upright position The touch screen therapy unit is laid on a level surface It is recommended that the ActiV A C Therapy Unit always be kept in the carrying case when in use Carrying
17. at do not need immediate attention Audio Pause EA A Countdown Timer and Audio Pause Indicator will be displayed in the upper left corner of the screen Alarms needing immediate attention override the Audio Pause feature See the Alerts and Alarms chapter of this manual page 18 for details on alarms and how to resolve them Z lt Z y 40 Operating Instructions Before starting therapy ensure that the dressing is in place the canister is connected and all clamps are open Power Therapy Unit On or Off The Power On Off button is located immediately below and to the left of the touch screen see page 6 for illustration Press and hold the Power On Off button for approximately two seconds to turn the ActiV A C Therapy Unit on or off Clinician Mode The therapy unit will go through a self check routine and then present LX NACE Jul192009 a Warning Message screen Press OK to continue to the Clinician Mode home screen shown left Sono Therapy YN Continuous Sy VN f O Therapy Off O f el i OmmHg Therapy On or Off _ On Off Start or stop V A C Therapy E A lighted green crescent means the function is on WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours Access Manual Therapy Settings From the Clinician Mode home screen press Therapy then Next to Therapy L er ac
18. ce may be used in both hospital and community settings This advanced wound healing technology is coupled with microprocessor controlled therapy units and 24 hour customer service and support V A C Therapy is prescribed by a physician or other licensed prescriber As with 1 any prescription medical device it is important to follow physician s orders and product instructions Do 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 healthcare provider the accompanying VA CS 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 Unit Touch Screen _ ActiV A C Canister KCI Authorized Maintenance Access Only Ka G lt a USB Data Port Healthcare Provider Use Only Power Connection Battery Charging Indicator Light Power On Off Button The USB Data Port is to be used with non powered USB flash drives memory sticks only No AC or battery powered drives computers computer equipment or other devices may be used Patient Mode Home Screen Budo Pause es OS Acti ew MA E ul 1 Countdown Timer EN SU ene J 18 06 Current Time Therapy Status Bar and
19. cess this screen Options available from this Therapy screen lt _ e Settings Manually set therapy i i e Seal Check Helps in find leaks Seal Check Dm A e Settings Guide Helps select preset therapy settings History View or export therapy history O E lt 2 D Z Press Exit to return to the Clinician Mode home screen 41 Z lt Z y y 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 Settings Pressure Intensity Options available from this Settings screen e e e Pressue Change pressure settings e Intensity Change Intensity e Continuous Toggle between Continuous and Intermittent therapy e Intermittent Set Intermittent therapy times L ea Press Exit when finished with the Settings screen and go to the Confirm screen Pressure Settings From the Clinician Mode home screen press Therapy then Next then Pressure L pa Settings then Pressure to access this screen A Use the and buttons to change the desired pressure AV Pressure can be set from 25 to 200 mmHg in increments of 25 mmHg 125 mmHg Press Exit to return to the Settings screen 10 a Default setting is 125 mmHg Intensity Control From the Clinician Mode home screen press Therapy then Next then Settings then Inte
20. eak rate The audible tone slows down and the bar graph decreases in height as the leak is found Seal Check Leak Rate High Orange bar graph indicates a significant leak Green bar graph indicates that the ActiV A C Therapy System is operating normally Line on bar graph is the transition point from green to orange and vice versa Seal Audio S 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 e when the canister is not securely connected to the therapy unit 1 Ensure the connector between dressing tubing and canister tubing is properly locked u gt mi Z 2 Ensure the canister is securely installed onto the therapy unit If the canister is properly installed it cannot be removed by gently pulling it 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 5 When finished press Exit to return to the Patient Mode home screen 6 If necessary contac
21. ect after OK is pressed Settings Guide Intensity default is Low Intensity can only be changed using Manual Therapy Settings page 41 N E lt 2 D Z 45 Z lt 2 y y Starting Therapy WARNING Ensure that a new V A C Dressing has been applied and therapy settings have been selected per physician s orders before starting therapy O Canister should be properly engaged for therapy to start Clinician Mode Press the Therapy On Off button to start therapy onion W AG2 Lu 19 2009 eeng 18 06 ST Utilities Therapy Continuous Therapy OT OmmHg The Therapy Start screen will appear Therapy Start 2k RES 0 High Cto Log Tool Seal Check Leak Detector Options available from this screen e Seal Check Leak Detector Use to view the integrity of the V A C Dressing and find any leaks e Log Tool Use to record canister change or the number of foam pieces used during a dressing change 46 Seal Check Leak Detector The Seal Check feature is used to help find negative pressure leaks and may be accessed three different ways e When therapy is started from the Clinician Mode home screen 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 Patients only have access to the Seal CheckTM feature through the Lea
22. esent This alert will be accompanied by a single audible tone The ActiV A C Therapy Unit continues to attempt to apply therapy O To resolve this alert 1 Ensure both clamps on the dressing and canister tubing are open Ka G lt a 2 Ensure that the tubing is not kinked crimped or blocked in any way Potential Blockage Detected 3 If the Blockage Alert remains after completing steps 1 and 2 lower Press for more information the therapy unit and tubing to level with or below the wound site If the alert is resolved by lowering the unit normal use may resume E Continuous Oj OmmHg OF L ea 4 Press Exit to return to the Patient Mode home screen Blockage Alarm Therapy Interrupted This alarm screen appears when a blockage is present This alarm will be accompanied by a repeating audible tone WARNING Therapy unit remains on however negative pressure at the wound may be below set pressure potentially compromising therapeutic benefits WARNING Pump may be running but therapy is interrupted Press for more information 1 Ensure both clamps on the dressing and canister tubing are open Audio Pause Reset e Ge y Ze Ensure that the tubing is not kinked crimped or blocked in any way Press Audio Pause to silence the audible tone for two minutes Audio Pause To resolve this alarm 3 If the Blockage Alarm Therapy Interrupted remains after completing steps 1 and
23. eturn to the tem to Log screen The current time and canister has been changed date will be recorded Will use the current time and date Press Cancel to return to the tem to Log screen without Cancel logging an entry i Press Dressing to access the No Foam Pieces screen No Foam Pieces ED Press OK to log number of dd Information displayed represents the last logged entry foam pieces and time date sms A A Use the and buttons to select the number of foam AV pieces used during the current dressing change Press OK to log the number of foam pieces used and return to the tem to Log screen The current time and Last recorded on 15 55 12 06 08 date will be recorded Ve 08 Press Cancel to return to the tem to Log screen without logging an entry Always count the total number of pieces of foam used in the wound Document the foam quantity and dressing change date on the drape or Foam Quantity Label if available and in the patient s chart O Logged information will appear in Therapy History as follows dd mm yy Time Event 12 06 06 15 54 Canister Changed 12 06 06 1955 Dressing Changed 4 Numeral after Dressing Changed represents the number of foam pieces recorded on the above screen N lt D E Z 49 View Or Export Therapy History Therapy History is a chronological log of dates and times for therapy starts stops therapy settings unit inactivity that exceeds 15 minu
24. g cord so that touch screen on therapy unit and arrow on charging cord connector both face up 5 Plug charging cord connector securely into therapy unit The plug indicator appears on the touch screen while the unit is plugged into a wall outlet It should take approximately six hours to fully charge the battery O To maximize battery life keep the unit plugged in whenever possible 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 page 8 will glow amber as the battery charges When the battery has reached full charge the light will glow green Battery Level Indicator The battery level is shown on the bottom of the touch screen page 6 JUE Fully Charged In Use Battery Low Charge battery soon Battery Critical Charge battery immediately u gt mi Z Canister Ka G lt a O Canister Changes O LU Latch Seals Release Canister eee Tubing Guide Canister Tubing Canister Clamp Stabilization Bumpers Canister Tubing Connector 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 Always apply canister straight on and straight off the therapy unit Do not twist or turn canister when installing or removing When not in use always store the ActiV A C Thera
25. he and buttons to scroll through the available wound type selections Press Next when finished to continue to the Se ect Pressure screen Use the and buttons to scroll through the pressure selections Pressure selections are in ranges for the wound type selected on the previous screen Select Within Available Range 125 mmHg Press Next when finished to continue to the next screen For wound types in which Intermittent is an option the Select Mode screen will appear If Intermittent is not an option the Confirm screen will appear 44 Settings Guide cont Use the and buttons to choose Continuous or Intermittent therapy Select Mode ED AV O Press Next when finished to continue If Intermittent therapy was chosen on the previous screen the Intermittent screen will appear On Time EN Use the and buttons to change the desired on and off time Both times can be set from one minute to ten minutes in one minute increments Press Next when finished to continue to the Confirm screen Settings Guide Confirmation J Once the settings are chosen the Confirm screen will appear Confirm l Press OK to continue to the Clinician Mode home screen if the displayed Partial Thickness Burns um gees Bsclrio ch tti ES Pressure 125mmHg settings are as desired or press Back to change any settings that are Mode Intermittent incorrect Intensity Low Settings take eff
26. herapy Unit includes wipedown of all hard surface components Follow your institutional procedures used for cleaning and disinfection of other hard surface durable electronic medical equipment The ActiV A C Therapy Unit must be cleaned and disinfected e f it becomes soiled during patient use e At least weekly Ensure that the ActiV A C Therapy Unit and its power supply are not connected to AC power when using cleaning fluids of any nature KCI recommends the following regarding cleaning and disinfecting KCI V A C Therapy devices e To help reduce risk of infection and contact with blood and body fluids use personal protective equipment PPE such as medical procedure gloves e Clean all organic material visible soil or body secretions from the therapy unit prior to disinfection e Use hospital grade cleaners and disinfectants e Do not immerse or saturate the therapy unit with fluids to avoid damage to the electronics in the device e Do not use alcohol based solutions around the touch screen edges or near gasket and power switches since alcohol based solutions will easily wick up into the screen and may cause equipment malfunction 30 Cleaning the Touch Screen a 1 Select the Screen Guard button on the Home screen pg 6 to activate Screen Guard i Lock button icon will close The next screen displayed will be the screen guard screen 2 Use a soft non abrasive cloth to gently clean the touch sc
27. his alarm will be accompanied by a repeating audible tone aa Press Audio Pause to silence the audible tone for two Audio Pause Canister Not Engaged oe To resolve this alarm WARNING Ensure canister is in place Press for more information 1 Remove the canister by pressing the canister latch release see page Audio Pause Reset 10 for illustration VN WS 2 Inspect the canister and ActiV A C Therapy Unit to ensure no Q foreign objects or debris interfere with the canister and therapy l unit s mating surfaces 3 Ensure both silicone seals and both canister stabilization bumpers are present see page 10 for illustration If any are missing or damaged contact KCI y z mi d 4 Re install the canister and ensure that it is fully engaged and latched An audible click should be heard when canister is properly installed 5 Press Reset to return to the Patient Mode home screen 6 Restart therapy by pressing the Therapy On Off button 7 tf this alarm continues to appear repeat steps 1 through 6 with a new canister Otherwise if alarm condition cannot be resolved contact your caregiver or KCI representative WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours 21 Leak Alarm This alarm screen appears when there is a significant negative pressure leak If this alarm is not resolved
28. i 5 Ensure that therapy is on by observing that the green crescent is lit on the Therapy On Off D button and the icon is rotating on the Patient Mode home screen Refer to Leak Alarm Therapy Interrupted section of this manual page 23 for procedures to restart therapy The patient s only access to the Seal Check Leak Detector is through the Leak Alarm screen 22 Leak Alarm Therapy Interrupted This alarm screen appears when a leak has not been resolved and therapy has been interrupted This alarm will be accompanied by a repeating audible tone gt Press Audio Pause to silence the audible tone for two Audio Pause S Za minutes To resolve this alarm y z rr Zz WARNING Press For more information i 1 Fix any leaks as described in the previous section Audio Pause Reset K ea 2 Press Reset on this screen to return to the Patient VN ei Mode home screen D 3 Restart therapy by pressing the Therapy On Off button WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours troubleshooting the leak as described in the previous section O If the leak condition is not resolved the Leak Alarm will reappear Continue If alarm condition cannot be resolved contact your caregiver or KCI representative 23 Blockage Alert This alert screen appears when a potential blockage is pr
29. in three minutes therapy will be interrupted This alarm will be accompanied by a repeating audible tone 7 Seal Y Flashing Green Oval Check g Ka G lt a Press Audio Pause to silence the audible tone for two Audio Pause SS Press Seal Check or for more information minutes If this alarm is resolved within three minutes without using the Seal Check Leak Detector the ActiV A C Therapy Unit will automatically reset and the Patient Mode home screen will be displayed Press Reset on this screen to return to the Patient Mode home screen Therapy will be off WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours 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 page 21 w Press the Seal Check button to use the Seal Check Leak Detector to help find leaks Refer Check to the Seal Check Leak Detector section of this manual page 16 for details on how to use the Seal Check feature 7 Seal Refer to the Application Instructions provided with V A C Dressings for information on using excess VA CS Drape material to seal the leak area O 4 When the leak is resolved press Exit on the Seal Check screen to return to the Home screen
30. ion Cleaning Operation Access basic operating guidelines y m Zz LKAP Access basic cleaning guidelines MEL Access general information for pausing or silencing alarms Clinician Mode Press Help to access the Help Menu Help Menu Y Bn no Clinician Mode has no patient operating screens Operating Clinician Patients should not proceed unless authorized by Instructions Mode Contact Information beem 29 Ka G a Care And Cleaning Standard Precautions The following are the KCI recommended daily and weekly cleaning and infection control procedures for the ActiV A C Therapy Unit Waste Disposal O 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 and 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 Discard all disposable items all tubing connectors clamps used canister used dressings etc in accordance with local medical waste disposal regulations Cleaning the ActiV A C Therapy Unit Cleaning and disinfection of the ActiV A C T
31. ion Settings _ 7 Brightness Low 2 DEA O Default setting is High Change AC Light eg Press AC Light to force the touch screen backlight to remain bright Utilities when the unit is connected to the ActiV A C Power Supply Time Date Region Z lt U Settings Zz JJ Y 56 Care And Cleaning Standard Precautions The following are the KCI recommended daily and weekly cleaning and infection control procedures for the ActiV A C Therapy Unit O 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 and 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 Waste Disposal Discard all disposable items all tubing connectors clamps used canister used dressings etc in accordance with local medical waste disposal regulations Cleaning the ActiV A C Therapy Unit Cleaning and disinfection of the ActiV A C Therapy Unit includes wipedown of all hard surface components Follow your institutional procedures used for cleaning and disinfection of other hard surface d
32. k Alarm screen when the ActiV A C Therapy Unit detects a possible leak How to Use the Seal Check Leak Detector When Starting Therapy Press the Therapy On Off button located on the Clinician Mode home screen to immediately display the Therapy Start screen OwO SON Therapy Start Orange bar graph indicates Pe a significant leak AT Rate Seal Check feature Green bar graph indicates that the ActiV A C Therapy System x High is operating normally l Press to turn the Seal Audio tone on or off Line on bar graph is the transition point from green I to orange and vice versa 1 Low The Seal Check Leak Detector uses an audible tone and bar graph to assist in finding leaks The frequency of the audible tone and the height of the bar graph will reflect the leak rate 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 green if there are no significant leaks 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 e when the canister is not securely connected to the therapy unit N E lt 2 D Z 47 Finding the Leak Using the Seal Check Leak Detector 1 Ensure the connector between dressing tubing and canister tubing is properly locked 2 Ensure the canister is
33. ked QUESHONS EE O E Z 2 D Z Z lt Z y Introduction This Clinician information provides operating instructions for the ActiV A C Therapy Unit to the healthcare professional Many features described are not available in Patient Mode Patient Mode allows the patient to start and stop therapy find leaks using the Seal Check feature and attend to alerts and alarms but does not allow changes to therapy settings V A C Vacuum Assisted Closure Therapy is a system that uses controlled continuous or intermittent negative pressure vacuum to create an environment that promotes wound healing by e preparing the wound bed for closure e reducing edema e promoting granulation tissue formation and perfusion e removing exudate and infectious material The ActiV A C Therapy System 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 This advanced wound healing therapy can be readily integrated into the healthcare provider s wound healing practice helping to optimize patient care and manage costs It is a flexible therapy that with appropriate precautions in place may be used in both hospital and community settings This advanced wound healing technology is coupled with microprocessor controlled therapy units and 24 hour customer service and support 36 Clinician Mode Home Screen Audio Pause Indicat
34. m tubing Operating Instructions Before starting therapy ensure that the dressing is in place the canister is connected and all clamps are open u gt Ka Power Therapy Unit On or Off The Power On Off button is located immediately below and to the left of the touch screen see page 6 for illustration Therapy Unit on or off Press and hold the Power On Off button for approximately two seconds to turn the ActiV A C The therapy unit will go through a self check routine and then present a Warning Message screen Press OK to continue to the Patient Mode home screen shown on page 6 Therapy On or Off Conor Start or stop V A C Therapy A lighted green crescent means the function is on WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours Seal Check Leak Detector When the ActiV A C Therapy Unit detects a significant leak the Leak Alarm will activate See Alerts And Alarms Leak Alarm page 22 f Seal Y Flashing Green Oval hec Aal U Ka G lt a TMJ ob Q RUE Gema Press the Seal Check button on the Leak Alarm screen Checky to use the Seal Check Leak Detector to help find leaks The Seal Check feature uses an audible tone and bar graph to help find leaks The frequency of the audible tone and the height of the bar graph will reflect the l
35. ng 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 Power On Off to power the unit off and then on Retry exporting Therapy History O IR feature is no longer available Use USB port only for data transfer If the above steps do not resolve the problem contact KCI for further assistance O E 2 D Z 51 zZ lt 2 U Helo Menu Change Languages Operating Patien Mode t Instructions T Contact Information T Language English AV O 1 Press Help to access the Help Menu 2 Press the Globe upper left to access the Language screen 3 Use the and buttons to select the desired language 4 Press Exit when finished 52 Onscreen Operating Instructions Help Menu L pa 2 lt lt Operatin Ope rating Instructions ee Instructions Contact Information 1 Press Help to access the Help Menu 2 Press Operating Instructions to access the Operating Instructions selection screen and browse the various available Help screens 3 Choose from Operation Cleaning instructions and Alarms for alarm descriptions and suggested resolutions A Press Exit when finished Access basic operating guidelines Access basic clea
36. ning guidelines Access general information for pausing or silencing alarms 53 N lt 2 D Z Change to Patient or Clinician Mode Q Press Help to access the Helo Menu MEC press Patient Mode to change to Patient Mode Operating Patient Instructions Mode S Sg Contact Information ee 7 Clinician Mode Press Clinician Mode to change to Clinician Mode Help Menu Operating Instructions ee Contact Information T A screen will appear to confirm which mode is set Only authorized caregivers should access Clinician Mode Select Cancel unless authorized Clinician Mode Cance STOP For safe and effective therapy only authorized caregivers should continue Select CANCEL unless authorized ED Press Cancel to return to the respective Help Menu screen 10 a Press OK to return to Patient Mode Press and hold OK for ok at least 5 seconds to proceed to Clinician Mode Z lt Z E U 54 Utilities From the Clinician Mode Home screen press Utilities to access this screen SEH Press Time Date to set the current time and calendar date Utilities L pr geg l SEN Press Region Settings to set the displayed Pressure Unit Time Date Brightness and Date Formats l E Press Brightness to set the display brightness of the touch Region i Brightness Settings CaS oe See screen AC Light Press AC Light to turn the AC Light on
37. nsity to change intensity level 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 O Default setting is Low 42 Continuous and Intermittent Modes Settings then Settings then Continuous to toggle between Continuous and O From the Clinician Mode home screen press Therapy then Next Intermittent therapy Pressure Intensity o v gt Continuous mode in use when green crescent is lit Continuous Intermittent Intermittent mode in use when green crescent is not lit OI A Continuous The words Continuous or Intermittent will appear in this area as modes are switched O Default setting is Continuous L ea Press Exit when finished with the Settings screen and go to the Confirm screen Intermittent Settings 1 Changes to Intermittent time intervals will take effect next therapy cycle l From the Clinician Mode home screen press Therapy then press Intermittent ED Settings then press Intermitte
38. nt to access this screen A 7 On Time Minutes Use the and buttons to change the desired on and off time Both times can be set from one minute to ten minutes in one minute increments Default setting is On Time five minutes Off Time two minutes Press Exit to return to the Settings screen N lt 2 D Z 43 CLINICIAN Settings Confirmation E Press Exit when finished with the Settings screen to go to Confirm L e the Confirm screen Pressure 125mmHg Mode He Press OK to continue to the Clinician Mode home screen if the displayed Intensity LOW settings are as desired or press Back to change any settings that are incorrect L dd If settings were changed with V A C Therapy off VAN press the Therapy On Off button to start therapy Settings Guide 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 O The Settings Guide helps select pre set therapy ranges according to wound type Should physician orders fall outside the pre set therapy ranges select Other in this mode or use the Manual Therapy Settings detailed earlier page 41 Select Wound Type Settings Guide then OK to access the Select Wound Type screen Partial Thickness A amp From the Clinician Mode home screen press Therapy then Next then Use t
39. nto ritte rren en eeeeedeeeeeaeeeeeseseeseeeeeeneeeeeneeseenneeeeans 25 a Ay E E ee 26 E tO Ft EE 26 senice Tiner e E GE 27 Se OT EE 28 OFM E EE 28 Sac OPa dung WTSI e 28 CGT GOS EE 29 Care Ana CHCA E 30 TAO eE EE 30 A nn O EAE EN EAEE A E E E 30 Cleaning the Adv ALCS Tera py UN EE 30 o e NE TT E EE 31 Peguer PG KE 32 SKIER onr Or Symbol SEO BE 56 A CH Customer EE EIERE 58 Introduction This Patient information provides operating instructions for the ActiV A C Therapy Unit Patient Mode allows the patient to start and stop therapy find leaks using the Seal Check feature and attend to alerts and alarms but does not allow changes to therapy settings V A C Vacuum Assisted Closure Therapy is a system that uses controlled continuous or intermittent negative pressure vacuum to create an environment that promotes wound healing by e preparing the wound bed for closure e reducing edema e promoting granulation tissue formation and perfusion e removing exudate and infectious material u gt mi Ka The ActiV A C Therapy System 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 This advanced wound healing therapy can be readily integrated into the healthcare provider s wound healing practice helping to optimize patient care and manage costs It is a flexible therapy that with appropriate precautions in pla
40. or with Countdown Timer Therapy On Off Button Help Button Battery Level Indicator the function is on Clinician Mode zc Ah CR Jul 192009 18 06 Continuous Therapy Off OmmHg Mode Indicator Current Date Current Time Therapy Status Bar and Display Area Screen Guard This icon rotates when the ActiV A C Therapy Unit is applying negative pressure A lighted green crescent means D An unlit crescent means the function is off Start or stop V A C Therapy WII Access Region Settings and Time Date buttons Screen Brightness and AC Light buttons Access Settings Seal Check Leak Detector Settings Guide and History buttons RR The plug indicator appears on the touch screen while the unit is plugged into a wall outlet N lt 2 D Z 39 Common Screen Control Buttons Most screens have one or more common control buttons These are Q Access Help screens when available Activate the Screen Guard feature to help prevent unintentional changes This feature should be used when cleaning the touch screen To release Screen Guard press 1 and then 2 Navigation Buttons One or more of these buttons may appear on a screen Leave the current screen Stop action in progress Go to the next screen Return to the previous screen Acknowledge the action is complete and display the next screen Audio Pause AT Press Audio Pause to silence for 60 minutes alerts th
41. p pocket of the carrying case for specific instructions concerning MRI and HBO therapy WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours If the area needing imaging is under the foam dressing there is a possibility of shadow casting The V A C GranuFoam Bridge Dressing contains additional synthetic materials which may pose a risk during HBO Therapy Other V A C Dressings are compatible with all imaging modalities The decision whether or not to keep the V A C Dressing in place should be made by the radiologist radiology technician and or your wound care practitioner 34 KCI Healing by design O activac For Clinician Use Only Patients Refer to Previous Section of This Manual Z lt Z y Clinician Table of Contents 1 ie ing e 38 aina OC HOMO E 39 COmmon SPSS CONTO Eae 40 NAM SUI T 40 PGI Ee 40 Mi e eo POE EE 41 POC VON Te cT e KEE o A e oo A 41 ll On Or O A eee ee E ee eee eee 41 Access Mania Tera pr ela c realities poi bereits dio eos 41 A UA PUES IA 42 SE le E 42 ME EEN 42 Ors ana We Modes T 43 Jet te alte EE SE o nn ne 44 SEENEN 44 GR les Lee ele a EE 45 SATO PCV AIO eege 46 Soa a aE a A id 47 How to Use the Seal Check Leak Detector When Starting Therapy 47 Finding the Leak Using the Seal Check Leak Detector 48 Foie tee 48 How to Use tne Log Too When S
42. py Unit in the carrying case without a canister in place Contact your KCI representative if the silicone seals canister latch guide or the canister stabilization bumpers are damaged or missing from the therapy unit 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 stopped when Canister Full Alarm sounds WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours Stop therapy by pressing the Therapy On Off button on the touch screen therapy is already off if addressing a Canister Full Alarm Do not turn power off to the ActiV A C Therapy Unit Slide both tubing clamps toward the tubing connector Tightly close both tubing clamps to prevent spillage of contents in tubing Several clicks should be heard Fig 1 y mi d Compress and then twist the tubing connectors until the locking tabs are disengaged and pull the connector apart to disconnect the dressing tubing from the canister tubing Fig 2a and 2b Press downward on the canister latch release Fig 3 Remove the canister from the therapy unit by pulling it directly away from the unit Fig 4 regulations Dispose of the canister according to institution and or local environmental Install the new canister onto the therapy unit by sliding the opening in the c
43. r 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 e Refer to the Standard Precautions section in the Care and Cleaning chapter of this manual for information on infection control Notice This product has been configured from the manufacturer to meet specific voltage requirements Refer to the Product Information Label for specific voltage Patient Table of Contents WITTEN TTT 1 Important Safety Iniormation Accompanies This DEVICE a ti 1 Disclaimer Of Warranty And Limitation Of REMCQY E 1 Important toma HOM For RE 2 Insel O EE 5 ACIN A TT IT TTT 6 SHI Mode Rome Ce CM a E E UU PEO o ER 6 COMMON Ee Rer rara acacia drid nta aia 7 Ns e E Eo ne e E A R EE E ER 7 ele 7 Batten Cng h less ase 8 SE Al WCC Or BEE 9 Be ee ao THT 9 EE 10 CAMS E LEE 10 O EE A e e A A 12 Carmo Case OPINO start R ana 13 dE PE D OE ee q EE 14 Fel UI US Te eT 15 csi 1 1 O ea E E EE EEE EE EE 15 Therapy ON Or OT EE 15 o a E E 16 PAANO TIE EO TTT 17 L AVG PAINS EN 18 Keel OWT PGE E E EE H EEE E E 19 sia Aa E y E E carte estes EE EAA E A A EE EA E EE 19 Canister Full Therapy Interrupted Alati coacalco alecoeies 20 CSR Not Engaged T eege 21 KI e LEE ER Leak Alarm Ener apy o E AEE EEEE 23 y z mi d Ka G a ee 4 TTT 24 alo ckade Alarma Mea de EE 24 E GE 25 Low Pressure Alarm Therapy Interrupted eri
44. rd may cause damage 3 To unlock the touch screen select the 1 button then the 2 button on the Screen Guard screen to return to the Home screen Z lt Z y 58 Explanation Of Symbols Used Reter to Explanation of Symbols Used if symbols appear on the product or accompanying documentation Warning or Caution of possible hazard IPXO to system patient or staff Important Operational Information Caution Consult Accompanying Documents WARNING Consult Accompanying Documents Consult Instructions For Use Keep Dry A Tripping Hazard y No Bathing or Showering gl Power On Off es Lie 5KA5 Serial Number Date of Manufacture Manufacturer RESTA UL ju 5KA5 Approximate symbol Temperature Limits Symbol Authorized Representative in the European Community FS L ED 20 gt P 3 gt EOS Not protected against harmful effects of water Alternating Current Direct Current Class Il Type B Applied Part This product is designated for separate collection at an appropriate collection point Do not dispose of as household waste Conforms with the Medical Device Directive 93 42 EEC and has been subject to the conformity procedures laid down in the council directive Medical Equipment classified with 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
45. reen O Do not use any liquid to clean the touch screen Do not use excessive force to clean the touch screen Pressing too hard may cause damage 3 To unlock the touch screen select the 1 button then the 2 button on the Screen Guard screen to return to the Home screen ER u gt Ka Ka G a Frequently Asked Questions PO gt Q Q PO PO PO PO How much does the ActiV A C Therapy Unit weigh The ActiV A C Therapy Unit weighs 2 4 lbs 1 08 kg 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 six 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 and what can do about it Though the ActiV A C Therapy Unit may be very quiet at times it may also make noises to enable the accurate delivery of negative pressure to the wound Noise may seem louder at night when surrounding noise level is greatly decreased When a leak is present unit noise may increase and the unit will begin to alarm Once the leak is fixed the unit will no longer alarm and become quieter The unit may also make a burping sound occasionally Placing the therapy unit below the level of the wound may allow the system to work more efficiently and more quietly It is normal to hear on again off again noi
46. se from the ActiV A C Therapy Unit What hapens if the ActiV A C Therapy Unit alarms The ActiV A C Therapy Unit is built with your safety in mind The ActiV A C Therapy Unit has alarms that you can see and hear which will alert you to a potential problem In most situations the reason for the alarm is easily fixed see pages 18 27 This is something your healthcare provider can explain in more detail so you are comfortable with this alarm system How do know if the ActiV A C Therapy Unit is working properly The Therapy Status Bar at the bottom of the touch screen displays specific therapy information The rotating icon also found in the Therapy Status Bar indicates the ActiV A C Therapy Unit is applying negative pressure The foam dressing will be collapsed indicating negative pressure is being applied Wound fluid may or may not be seen moving in the tubing 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 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 it directly away from the unit What steps should I take before bathing Do not take the ActiV A C Therapy Unit into the shower or tub Turn therapy and power off and disconnect canister tubing from dressing tubing The clear drape is waterproof you may wash or
47. solve this alarm WARNING Press Reset and restart therapy Press for more information 1 Press Reset to return to the Patient Mode home screen Audio Pause S Restart therapy by pressing the Therapy On Off button a 3 If V A C Therapy is not desired turn the ActiV A C Therapy Unit off using the Power On Off button on the front of the unit WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off 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 Several different types of system errors may occur A number will appear in the yellow alarm box that represents the diagnostic code of the technical fault This alarm will be accompanied by a repeating audible tone lt a Press Audio Pause to silence the audible tone for two Audio Pause S Za minutes To resolve this alarm WARNING Turn therapy unit off then on If error continues contact KCI Press for more information 1 Record the error number 2 Turn the unit off and then on using the Power On Off button on the front of the unit Audio Pause If alarm condition cannot be resolved contact your caregiver or KCI representative WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interr
48. t your healthcare provider or KCI for assistance or further information Alerts And Alarms ATTENTION Important Information about Alerts and Alarms An Alert will be displayed on the touch screen when the ActiV A C Therapy Unit detects a condition that requires patient or caregiver attention Ka G E a Alerts will be accompanied by a single audible tone An Alarm will be displayed on the touch screen 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 NET Press Audio Pause to silence the audible tone for two minutes SAA CG Press Help for more information about the alert or alarm O If alarm conditions cannot be resolved contact your caregiver or KCI WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours Battery Low Alert This alert screen appears approximately two hours before the battery power runs out This alert will be accompanied by a single audible tone To resolve this alert Battery Low Alert 1 Connect the therapy unit to a wall outlet using the ActiV A C Power Supply to recharge battery The light next to the bottom left of the touch screen will glow amber as the battery charges Refer to Battery low charging
49. tarting TAS EE 48 Me EXON WON ay TG E 50 V WNT ea OY E UU III E EE EPEE e o A 50 Eon R TT PET E E E ee E SE E eae eee 51 B lleger as 51 mA EE SE An o E A EAT P EA 52 neer en OPa HET WTS gl e TEE 33 o cc A AP en 54 Beie 55 Stee e AE EE 55 Change Pressure Units and Date enn 56 Change Scien INS SS ee 56 o e 56 36 EE ee WEE SE Aa o A al Waste Ree assent ee bg es EE epoca epee E elote es sevens toe 57 Cleaning the ActiV A C Therapy Un 57 ere e TU Ee EE 58 SRI ae e Enter e EE 59 e 60 Customer Contacta 61 See The Following Pages Of The Patient Section Of This User Manual For Additional Information A e PP 1 Important Satety Information Accompanies This Device Ste loci 1 Disclaimer Of Warranty And Limitation Of REMC EE 1 Ile eis eee TOU Util ON e RE E E DE AAA EEA E AREE 4 POO CTC E 5 PANA T UN EE 6 so a EEE EEE E E E PES ES OU o E 8 Paker lo e A e OU A 9 T E ING a a E E E E E E E E E E EES 9 SA 10 E SSA 10 ETIE E 12 Canino Case EE eege ig steet EEN 14 AC ET O 18 SiO Ee TTT 19 1 A ENEE Canister Full Therapy Interrupted arn siii detroit aad Camistar Not arr se dae tacon Re EE Leak Alora e Ee 04 les c o AA Pe EET E a ES a c EE es PA a En die EE LOV PEO STE Low Pressure Alarm Therapy INterrupted ccccccoooonnccconccooonnnnnnnnnnornnnnnnnonnronnnnnnnnnnrnnnnnnnnnnrnnnnnnnnnnnnnnnnnnnnnennnnnncnnenenineos Aa sles IP TIE TTT EE SUIT H d e Io nn A Service Timer Expired Alert EE Freguentiy AS
50. tes alarm occurrences and manually logged 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 l Starting from the Clinician Mode home screen press Therapy then Next Therapy History L er then History to access the Therapy History screen The Therapy History screen has two options Export History e View History View Therapy History on screen A A e Export History Access screens where the Therapy History Report can be transferred via USB IR feature is no longer available Use USB only port for data transfer View Therapy History History mm dd yy Time Event 12 06 08 15 48 Unit On 12 06 08 15 48 Therapy On i Use the and buttons to scroll through the Therapy 12 06 08 15 54 Canister Changed AV History Report Press the View History button on the Therapy History screen to access L pa the on screen therapy history display 12 06 08 15 55 Dressing Changed 4 12 06 08 22 23 Canister Full 12 06 08 22 23 Therapy Off 12 06 08 22 27 Therapy On Hold the and buttons to rapidly scroll through the 12 06 08 22 29 Auto Therapy Off Leak E recorded information Due to space limitations the Therapy History Report does not spell out wound types A number is used instead according to the following chart 1 Acute Traumatic 2 Partial Thickness Burns 3 Dehisced Wounds S 4 Meshed Graf
51. ts U 5 Pressure Ulcers gt 6 Chronic Ulcers mr 7 Flaps Ka 8 Other L ea Press Exit to return to the Therapy History screen 50 Export Therapy History Report only for use by or for KCI personnel or clinicians using KCI products and 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 O This data is protected by copyright law and is likely confidential It is intended To access the USB Data Ports the ActiV A C Therapy Unit must be removed from the carrying case S s Press the Export History button on the Therapy History Export History L ea screen to access the Export History screen USB devices should be connected directly and only unpowered USB mass storage devices should be Export To USB Export To IR attached to the ActiV A C Therapy Unit AC or battery Eo Eo powered drives computers computer equipment Data is exported with unit serial number other devices or USB extension leads should not be but without patient identifier connected to this device Press Export to USB to begin data transfer Follow screen directions EE Ed IR feature is no longer available Use USB port only for data transfer L ea Press Exit to return to the Therapy History screen USB Export Issues USB e Ensure that the USB flash drive memory stick bei
52. upted or off for more than two hours 26 Service Timer Expired Alert This alert screen appears when the ActiV A C Therapy Unit has reached its service time limit Once the Service Timer has expired this alert will appear every time the unit is powered up When Days Left reaches zero this alert will reappear periodically during therapy To resolve this alert a 1 Contact KCI to obtain a new Service Timer code Contact KCI Days Left 3 gt 4 y mi d 2 Press Enter Code to enter the code obtained from KCI N 27 Ka G lt a Help Menu Change Languages Operating Instructions Contact Information Language English Operating Instructions T Contact Information y Clinician Mode Clinician Mode Asien E Operating USAS 1 Press Help to access the Help Menu 2 Press the Globe upper left to access the Language screen 3 Use the and buttons to select the desired language 4 Press Exit when finished 1 Press Help to access the Help Menu 2 Press Operating Instructions to access the Operating Instructions selection screen and browse the various available Help screens 28 Onscreen Operating Instructions cont 3 Choose from Operation Cleaning instructions and Alarms for alarm Operating Instructions L er descriptions and suggested resolutions A Press Exit when finished Operat
53. urable electronic medical equipment The ActiV A C Therapy Unit must be cleaned and disinfected e If it becomes soiled during patient use e At least weekly Ensure that the ActiV A C Therapy Unit and Its power supply are not connected to AC power when using cleaning fluids of any nature KCI recommends the following regarding cleaning and disinfecting KCI V A C Therapy devices e To help reduce risk of infection and contact with blood and body fluids use personal protective equipment PPE such as medical procedure gloves e Clean all organic material visible soil or body secretions from the therapy unit prior to disinfection e Use hospital grade cleaners and disinfectants e Do not immerse or saturate the therapy unit with fluids to avoid damage to the electronics in the device N E 2 gt Z e Do not use alcohol based solutions around the touch screen edges or near gasket and power switches since alcohol based solutions will easily wick up into the screen and may cause equipment malfunction cR Cleaning the Touch Screen a 1 Select the Screen Guard button on the Home screen pg 38 to activate Screen Guard i Lock button icon will close The next screen displayed will be the screen guard screen 2 Use a soft non abrasive cloth to gently clean the touch screen O Do not use any liquid to clean the touch screen Do not use excessive force to clean the touch screen Pressing too ha
54. will be accompanied by a repeating audible tone WARNING Therapy unit remains on however negative pressure at the wound may be below set pressure potentially compromising therapeutic benefits Press Audio Pause to silence the audible tone for two minutes Audio Pause To resolve this alarm WARNING Pump may be running but therapy is interrupted Press for more information 1 Ensure both clamps on the dressing and canister tubing are open Audio Pause 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 lower the therapy unit and tubing to level with or below the wound site If the alert is resolved by lowering the unit normal use may resume y 4 Press Reset to return to the Patient Mode home screen If alarm condition cannot be resolved contact your caregiver or KCI representative WARNING According to clinician instructions replace V A C Dressing with alternate dressing if therapy is interrupted or off for more than two hours 25 Ka G lt a Therapy Inactive Alarm This alarm screen appears when therapy has been off for 15 minutes with the unit powered on and without using the touch screen This alarm will be accompanied by a repeating audible tone gt Press Audio Pause to silence the audible tone for two Audio Pause Therapy Inactive oa To re
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