User Manual. December 2006 M Rev.A

Transcription

1 User Manual December 2006 M Rev.A

2 WARNING Important Safety Information accompanies this device. Indications, Contraindications, Warnings, Precautions and other Safety Information are contained in the V.A.C. Therapy General Safety Information Sheet. This sheet is located with the Therapy Unit. 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 General Safety Information Sheet is missing, imediately contact your local KCI representative. Refer to back cover for contact information. V.A.C. Therapy Safety Information can be found on the internet at or outside the U.S.A.

3 Quick Reference System Layout Power On/Off Button Canister Release Button Touch Screen User Interface InfoV.A.C. 500ml Canister Stylus Data Door Memory Card Slot Infrared Data Port The connection ports are for clinician use only Hanger Arm Carry Handle Hanger Knob Battery Charging Indicator Light Power Connection

4 Typical V.A.C. Dressing The V.A.C. Dressing is not included with the Therapy Unit. A variety of V.A.C. Dressings are available for use with the InfoV.A.C. Therapy System. All M827 series V.A.C. Dressings will contain one Measuring Ruler with a Calibration Reference Square

5 Control Screen Audio Pause Indicator with countdown timer 1.20 Patient Home Screen 6 Jun :06 Mode Indicator Current Date Current Time /Off Button On/Off Night Mode Therapy Status Bar and Display Area Help Button Screen Guard Battery Level Indicator A green lighted crescent means the function is On. This plug indicator appears while plugged into a wall outlet This icon rotates when the InfoV.A.C. Therapy Unit is applying negative pressure An unlit crescent means the function is Off. starts or stops V.A.C. Therapy. displayed in the Therapy Status Bar and Display Area indicates that a Patient Record is active. Control Screen Buttons Most screens have one or more common control buttons: accesses Help screens. activates the Screen Guard feature to help prevent unintentional screen 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 the following buttons may appear on a screen: leaves that particular screen. stops action in progress. 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.

6 Canister Installation Press to turn the device on. Attach the canister. Slide the canister into the end of the InfoV.A.C. Therapy Unit as illustrated. canister is correctly installed. 3. Connect the Canister tubing to the Dressing tubing: Push the connectors together. 4. Open all tubing clamps as illustrated. Closed Clamp Open Clamp

7 INTRODUCTION... 1 InfoV.A.C. Therapy System Key Features...1 Adjustable Negative Pressure Settings and Therapy Modes...1 Seal Check Tool...1 Patient Mode Control...1 Therapy History Report...1 On-Screen Operating Instructions...2 Touch Screen User Interface...2 Settings Guide...2 SensaT.R.A.C. System...2 In-Line Canister/Dressing Connectors...2 Canisters...2 Canister Release Button...2 Intensity Setting...2 Therapy Days Display...2 Battery Operation...2 V.A.C. Dressings...3 Wound Image Analysis...3 Patient History Report...3 Hanger Mechanism...3 Attaching InfoV.A.C. Therapy Unit to Other Devices...4 Devices that can be attached to the InfoV.A.C. Therapy Unit...4 Equipment to which the InfoV.A.C. Therapy Unit can be attached...4 Protection Against Hazards...5 Disposal...5 Power Supply...5 PREPARING THE INFOV.A.C. THERAPY UNIT FOR USE... 6 Battery Charging Indicator Light...7 Battery Level Indicator...7 Therapy Unit Placement...7 Attaching the InfoV.A.C. Therapy Unit to an IV Pole...8 Attaching the InfoV.A.C. Therapy Unit to a bed footboard...9 To release the InfoV.A.C. Therapy Unit from an IV pole or bed...9 Installation of the 500ml and 1000ml canisters...10 Changing the Canister Canister Change Procedure Using the 300ml ActiV.A.C. Canister with the InfoV.A.C Installing the 300ml ActiV.A.C. Canister...13 Removing the 300ml ActiV.A.C. Canister...13 i

8 ii OPERATION Power Up Procedures Initial Power up...14 Power Down Procedures Touch Screen User Interface Control Screens...15 Patient Mode...15 Clinician Mode...15 Restricted Mode (Patient History)...15 PATIENT MODE CONTROL SCREENS Patient Home Screen Control Screen Buttons...16 Night Mode Function...17 Patient Mode Help Menu Screen...18 Operation Instructions Screen...18 CLINICIAN MODE CONTROL SCREENS Clinician Home Screen Control Screen Buttons...19 To Return to the Patient Home Screen:...20 Therapy Start Screen...20 Seal Check Overview...20 How to Use Seal Check (When Starting Therapy)...21 Finding the Leak Using Seal Check...21 Log Tool Overview...22 How to Use Log Tool (When Starting Therapy)...22 Therapy Screen...24 Settings Screen (manual)...25 Intensity Control...25 Pressure Screen...26 Intermittent Screen SETTINGS GUIDE Seal Check Screen...31 Therapy History Screen...31 PATIENT HISTORY SCREENS Enter Access Code Screen...32 Create a New Access Code...33 Change Patient ID Screen...33 Patient History Menu Screen...34 View History Screen...35 Delete History Screen...36 Export Patient History Screen Memory Card Transfer Screen...38 IR Transfer Screen...39 USB Transfer Screen...40 Graph Screen...41 Select Leak Alarm Threshold Screen...41

9 WOUND IMAGE ANALYSIS Imaging Screen...43 File Select Screen...44 Image Reference Calibration...45 Wound Area Trace...46 Calculate Wound Volume...48 CLINICIAN UTILITIES Changing Time and Date...49 Changing Pressure Units and Date Format...50 ALERTS AND ALARMS Alert Condition...51 Alarm Condition...51 Index of Alerts and Alarms...51 Battery Low Alert...52 Battery Critical Alarm...52 Canister Full Therapy Interrupted Alarm...53 Canister Not Engaged Alarm...54 Leak Alarm...55 Leak Alarm Therapy Interrupted...56 Blockage Alert...57 Blockage Alarm Therapy Interrupted...57 Low Pressure Alert...58 Low Pressure Alarm Therapy Interrupted...58 Therapy Inactive Alarm...59 System Error Alarm Therapy Interrupted...59 Internal Temperature Alarm...60 Service Timer Expired Alert...60 Pressure Deviation Therapy Interrupted...61 CARE AND CLEANING Cleaning the Touch Screen User Interface...62 Daily Care and Cleaning...62 Weekly Care and Cleaning...62 SPECIFICATIONS InfoV.A.C. Therapy Unit...63 Power Supply...63 InfoV.A.C. Therapy Unit...63 Electrical Data (Power Supply)...63 Storage and Environmental conditions iii

10 iv Important Safeguards WARNING: To help reduce the potential risk of serious or fatal injury, always consult a physician, and read and follow all Instructions for Use, including Safety Information, Dressing Application Instructions, V.A.C. Therapy Unit instructions, and V.A.C. Therapy Clinical Guidelines prior to each use. Additional information can be found on the internet at or outside the U.S.A. Important Safety Information is supplied with the InfoV.A.C. Therapy Unit. If any part of the InfoV.A.C. User Manual or the V.A.C. Therapy General Safety Information Sheet is 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: The product must be used in accordance with this manual. Please note: To help provide safe and effective use, V.A.C. Dressings are only to be used with V.A.C. Therapy Units. The electrical installation of the room must comply with the appropriate electrical wiring standards. Refer to the Care and Cleaning section for recommended daily and weekly cleaning for the InfoV.A.C. Therapy Unit. Never operate this product if it has a damaged power cord, power supply or plug. Should the power cord, power supply or plug be found to be worn or damaged, contact KCI. Refer to back cover for contact information. Never drop or insert any object into any opening or tubing of the InfoV.A.C. Therapy System. Do not use attachments not recommended by KCI. Keep the InfoV.A.C. Therapy System away from heated surfaces. Although the InfoV.A.C. Therapy System conforms to the intent of the standard IEC in relation to Electromagnetic Compatibility, electrical equipment may produce interference. If interference is suspected, move the equipment and contact KCI. Liquids remaining on the electronic controls can cause corrosion that may cause the electronic components to fail. Component failures may cause the unit to operate erratically, possibly producing potential hazards to patient and staff. Therapy Unit. If spills do occur, unplug the unit immediately if plugged into electrical source and clean the unit with an absorbent cloth. Ensure there is no moisture in or near the Power Connection and Power Supply Components before reconnecting power. If the InfoV.A.C. Therapy Unit is not working properly, contact KCI. Refer to back cover for contact information.

11 1 Introduction 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 optimize patient care and manage costs. This advanced wound healing technology, up, helps provide peace of mind for both clinicians and patients. The V.A.C. family of devices is used to promote wound healing through multiple technology). The InfoV.A.C. ) for use on a variety of chronic and acute wound types. InfoV.A.C. Therapy System Key Features Adjustable Negative Pressure Settings and Therapy Modes pressure or intermittent negative pressure. Seal Check Tool Dressing through the use of audible tones and on-screen visual aids during the troubleshooting process. Patient Mode Control screen menus. Therapy History Report transferred from the InfoV.A.C. Therapy Unit electronically in the form of a Therapy 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.

12 2 On-Screen Operating Instructions Abbreviated Operating Instructions are available on-screen. Always familiarise Touch Screen User Interface 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 site, helping to deliver consistent therapy. This system includes Therapy Unit hardware, software, wound exudate collection canister, canister detection method, Pad. In-Line Canister/Dressing Connectors clamps to conveniently allow the wound dressing to be temporarily disconnected from the InfoV.A.C. Therapy Unit. Canisters The InfoV.A.C. Therapy Unit is optimized for use with the InfoV.A.C. InfoV.A.C. latex free, sterile components. The 1000ml canister is intended for use in acute care settings only Canister Release Button Intensity Setting initiation of therapy. The lower the intensity setting, the slower the target therapy level will be reached. Therapy Days Display the patient. Battery Operation In order to facilitate mobility and help patients return to daily activities, battery operation is available with the InfoV.A.C. Therapy Unit. During typical usage, the battery may provide up to 11 hours of operation before needing to be recharged.

13 3 V.A.C. Dressings A variety of V.A.C. Dressings are available for use with the InfoV.A.C. Therapy Wound Image Analysis Digital wound images can be downloaded from a digital camera into the InfoV.A.C. Therapy Unit. When the clinician has traced the wound perimeter on-screen with the provided stylus, an automated wound image surface area and volume measurement can be made and trended. A chronological graphical history of the wound (with wound image area trend chart) can be viewed on-screen or this information can be transferred from the InfoV.A.C. Therapy Unit electronically. This information is intended to be used by the treating clinician as a mechanisim for providing a record of wound healing progress. Wound imaging area and volume calculation features are not intended to be exact measurements and are not intended for use in the diagnosis and treatment of wounds. Patient History Report A chronological, pictorial history and log of wound image measurements and clinician entered data can be reviewed on-screen or transferred from the InfoV.A.C. Therapy Hanger Mechanism The Therapy Unit can be securely mounted to an IV pole, a bed footboard or a wheelchair.

14 4 Attaching InfoV.A.C. Therapy Unit to Other Devices Devices that can be attached to the InfoV.A.C. Therapy Unit The InfoV.A.C. canisters and is compatible with ActiV.A.C. The InfoV.A.C. Therapy Unit can transfer data to and from a memory card. The Memory Card Slot is for Clinician use only. The InfoV.A.C. The Infrared Data port is for Clinician use only. The InfoV.A.C. Only unpowered USB Mass Storage Devices should be attached to the InfoV.A.C. Therapy Unit USB Devices should be connected directly and should only be used with non-powered memory sticks and drives only. AC or Battery powered drives, computers, computer equipment, other devices or USB extension leads should not be used. The USB port is for Clinician use only. The InfoV.A.C. Therapy Unit can be powered and recharged with the supplied Only the Power Supply supplied with the InfoV.A.C. Therapy Unit (part number M ) should be used to power the device or to recharge the battery. Therapy Unit can be attached The InfoV.A.C. Therapy Unit can be attached to the footboard of most hospital beds. The InfoV.A.C. Therapy Unit can be attached to a range of IV Poles. The optimal size IV pole that can be used to hold the InfoV.A.C. Therapy Unit is between 19mm and 40mm in diameter. The InfoV.A.C. Therapy Unit can be attached to most wheelchairs.

15 5 Protection Against Hazards Disposal Discard all disposable items (all tubing, connectors, clamps, used canister, used dressings, etc.) in accordance with local medical waste disposal regulations. Properly dispose of all parts according to institutional procedures, local, state and federal regulations. The InfoV.A.C. Therapy Unit and the InfoV.A.C. to KCI for disposal at the end of their operational life. Power Supply The system should never be operated with a worn or damaged Power Cable or damaged, contact your local KCI representative or agent for a replacement. Only the Power Supply supplied with the InfoV.A.C. Therapy Unit (part number M ) should be used to power the device. The battery in the InfoV.A.C. Therapy Unit is not a user serviceable part. If battery problems are suspected, the system should be returned to KCI for servicing.

16 6 Preparing the InfoV.A.C. Therapy Unit for Use Before preparing the InfoV.A.C. Therapy Unit for use, inspect the unit for any damage or contamination, see the chapter on Care and Cleaning. Use only the Power Supply provided with the InfoV.A.C. Therapy Unit. Using any other power supply may damage the InfoV.A.C. Therapy Unit. Power cords may present a tripping hazard. Ensure that all cords are out of areas where people may walk. The InfoV.A.C. outlet and one that plugs into the InfoV.A.C. Therapy Unit. on country requirements Plug the AC Power Cord into the Power Supply. Plug the AC Power Cord into an AC wall outlet. Locate the White Arrow on the InfoV.A.C. Power Supply Charging Cord Connector. The Arrow should be up as the cord is plugged into the power connection on the InfoV.A.C. Therapy Unit. completely discharged state.

17 7 Battery Charging Indicator Light When the InfoV.A.C. Therapy Unit is correctly plugged into the InfoV.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 Charged In Use Battery Low, Charge battery soon Therapy Unit Placement The InfoV.A.C. Therapy Unit may be attached to the footboard of a hospital bed, a wheelchair or to an IV pole. If required, it may be placed on a solid, level surface where it does not cause an obstruction. Ensure that the InfoV.A.C. Therapy Unit is below the height of the wound. The InfoV.A.C. Therapy Unit should be placed where cables and tubes cannot be caught on passing objects. Power cords and tubing may present a tripping hazard. Ensure that all cords and tubing are out of areas where people may walk. The InfoV.A.C. your physician and contact KCI for optional V.A.C. units designed for

18 8 Attaching the InfoV.A.C. Therapy Unit to an IV Pole 1. Before pulling out the Hanger Arm, the Arm must be in the Horizontal position. 2. Hold the InfoV.A.C. Therapy Unit by the carry handle, grip the Hanger Knob and pull the Hanger Arm out. 3. Place the Hanger around the IV pole ensuring that the pole is in the vertical rubber groove on the rear of the InfoV.A.C. Therapy Unit. Allow the Hanger to close pulling the unit onto the pole. 4. Turn the Hanger Knob to lock the Hanger Arm in place. When the lock symbol on the Hanger Knob aligns with the arrow on the Therapy Unit, this indicates that the mechanism is locked. An audible click also indicates that the mechanism is locked. The InfoV.A.C. The Hanger Knob can be turned past the lock position to further secure the InfoV.A.C. Therapy Unit. Hand tighten only, excessive force or tools should not be used.

19 9 Attaching the InfoV.A.C. Therapy Unit to a bed footboard 1. Before pulling out the Hanger Arm, the Arm must be in the vertical position. 2. Hold the InfoV.A.C. Therapy Unit by the carry handle, grip the Hanger Knob and pull the Hanger Arm out. 3. Place the Hanger over the footboard. Allow the Hanger to close pulling the unit onto the footboard. 4. Turn the Hanger Knob to lock the Hanger Arm in place. When the lock symbol on the Hanger Knob aligns with the arrow on the Therapy Unit, this indicates that the mechanism is locked. An audible click also indicates that the mechanism is locked. the InfoV.A.C. To release the InfoV.A.C. Therapy Unit from an IV pole or bed 1. Hold the InfoV.A.C. Therapy Unit by gripping the Carry Handle. 2. Reverse the attaching procedure.

20 10 Installation of the 500ml and 1000ml canisters 1. Attach the canister. Slide the canister into the end of the InfoV.A.C. Therapy Unit as illustrated. 2. Connect the Canister tubing to the Dressing tubing: Push the connectors together. Twist connectors until the locking tabs are fully engaged, as illustrated. 3. Open all tubing clamps as illustrated. Closed Clamp Open Clamp

21 11 Changing the Canister A canister may be changed, under routine conditions or under alarm conditions. Under routine conditions the Canister Release Button Stop therapy by pressing on the Touch Screen User Interface. When changing the Canister under routine conditions do NOT turn power Off to the InfoV.A.C. Therapy Unit. screen will be displayed and therapy will be Off. Canister Change Procedure 1. Close all tubing clamps as illustrated. Open Clamp Closed Clamp 2. Disconnect the Canister tubing from the Dressing tubing: Twist connectors until the locking tabs are fully disengaged, as illustrated. Pull the connectors apart.

22 12 3. Press the Canister Release Button the cradle.. The canister will eject but remain in Canister Release Button 4. Lift the canister out of the cradle. 5. Dispose of the canister according to hospital or facility protocol. Under clinician supervision, replace V.A.C. Dressing with alternative dressing if therapy is interrupted for more than two hours.

23 13 Using the 300ml ActiV.A.C. Canister with the InfoV.A.C. Installing the 300ml ActiV.A.C. Canister 1. Attach the canister. Therapy Unit as illustrated. 2. Connect the canister tubing to the Dressing tubing: Push the connectors together. Twist connectors until the locking tabs are fully engaged, as illustrated. 3. Open all tubing clamps as illustrated. Closed Clamp Open Clamp Removing the 300ml ActiV.A.C. Canister Hold the ActiV.A.C. Press the Canister Release Button. When the canister release button is pressed the ActiV.A.C. Canister is NOT held in place by the cradle of the InfoV.A.C. Therapy Unit. When removing the 300 ml ActiV.A.C. Canister from the InfoV.A.C. Therapy Unit ensure that the Canister is held FIRMLY before pressing the Canister Release Button.

24 14 Operation Before powering ON the therapy unit, ensure that: The V.A.C. Dressing is applied as described in the Application Instructions supplied with the V.A.C. Dressing. The InfoV.A.C. Canister is attached as described in the Canister Installation section of this manual. The InfoV.A.C. described in the Preparation for Use section of this manual. Power Up Procedures Initial Power up 1. Always connect the InfoV.A.C. Therapy Unit to the Power Supply as described in the Preparation for Use section of this manual. 2. Press and hold the the Power On/Off button for approximately two seconds to turn the InfoV.A.C. Therapy Unit On. The Power Button will illuminate and the Touch Screen User Interface will activate. The InfoV.A.C. Power Down Procedures To power the InfoV.A.C. Therapy Unit down, press and hold the button for two seconds. The button Under clinician supervision, replace V.A.C. Dressing with alternative dressing if therapy is interrupted for more than two hours. Touch Screen User Interface The display on the front of the unit is a touch sensitive device. The system Control Screens will be shown on this display. These screens will display information on current system operations, settings and allow the alteration of them. The operation of the Touch Screen Interface is detailed in the following pages.

25 15 Control Screens The Three levels of Control Screens are Patient Mode, Clinician Mode and Restricted Mode. Patient Mode The Patient Mode may be selected by the clinician to allow a patient to control certain elements of their therapy. This mode does not allow the patient to access or alter their therapy settings. Night mode and the Screen Guard can be activated and the Help Screens can be accessed. Clinician Mode The Clinician Mode Screens allow a clinician to set and change therapy settings and provide a gateway to the Restricted Mode. The clinician can view therapy history. Restricted Mode (Patient History) The Restricted Mode Screens allow access to patient wound images, image area trend charts and other patient health information that has been entered by the caregiver. The Leak Alarm sensitivity can be adjusted in this mode. When this mode is active the therapy and patient history can be exported. A secure password system protects the restricted mode from unauthorised access.

26 16 Patient Mode Control Screens Patient Home Screen Audio Pause Indicator with countdown timer 1.20 Patient Home Screen 6 Jun :06 Mode Indicator Current Date Current Time /Off Button On/Off Night Mode Therapy Status Bar and Display Area Help Button Screen Guard Battery Level Indicator This plug indicator appears while plugged into a wall outlet This icon rotates when the InfoV.A.C. Therapy Unit is applying negative pressure A green lighted crescent means the function is On. An unlit crescent means the function is Off. starts or stops V.A.C. Therapy. displayed in the Therapy Status Bar and Display Area indicates that a Patient Record is active. Control Screen Buttons Most screens have one or more common control buttons: accesses Help screens. activates the Screen Guard feature to help prevent unintentional screen changes. This feature should be used when cleaning the touch screen.

27 17 Night Mode Function The Night Mode Function on the Patient Home Screen should be used to ensure minimum disruption from light stimulation to patients at night. When the Night Mode Function is active, Therapy continues as normal. The Touch Screen User Interface will darken and the green On/Off Button will dim. Patient Home Screen 6 Jun :06 On/Off Night Mode on the Patient Home Screen activates the Night Mode Function. After two minutes the screen will darken. The screen will illuminate when touched and display: Patient Home Screen 6 Jun :06 On/Off Exit Night Mode Night Mode is Active deactivates the Night Mode Function.

28 18 Patient Mode Help Menu Screen on the Patient Mode Home Screen or any Patient Mode screen where this button appears calls up the Patient Mode Help Menu Screen. Help Menu Exit Operating Instructions Clinician Mode Language About calls up the Operation Instructions. calls up the About Screen. changes to Clinician Mode (Press and hold for three seconds). calls up the Language Select Screen. returns to the Patient Home Screen. Operation Instructions Screen The Operation Instructions provide help in operating the InfoV.A.C. Therapy Unit. Operating Instructions Exit Operation Cleaning Alarms on the Help Menu screen activates this screen.

29 19 Clinician Home Screen Clinician Mode Control Screens Clinician Home Screen 6 Jun :06 On/Off Therapy Utilities Night Mode A green lighted crescent means the function is On. An unlit crescent means the function is Off. starts or stops V.A.C. Therapy. opens the Therapy Screen. opens the Utilities Screen. activates Night Mode. displayed in the Therapy Status and Display Area indicates that a Patient Record is active. Control Screen 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 changes. This feature should be used when cleaning the touch screen. To release Screen Guard, press 1 and then 2.

30 20 To Return to the Patient Home Screen: Press the Press the button. button on the Help Menu screen. 3. Press and hold the button to display the Patient Home Screen. Therapy Start Screen The Therapy Start Screen is displayed when Home Screen. Therapy Start is pressed on the Clinician Exit Leak Rate High Log Seal Audio Low A Green bar graph indicates that the InfoV.A.C. Therapy System is operating normally. Ensure that a new V.A.C. Dressing was applied and therapy settings have been selected per physician s orders before starting therapy. 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 InfoV.A.C. Therapy Unit detects a possible leak. Seal Check features an audible tone that changes frequency as the rate of the leak changes. Pressing the Seal Audio button will switch between the audible tone being on or off. 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 different ways: When Therapy is started from the Clinician Mode Home screen, discussed on the following pages. When the Seal Check button is pressed on the Therapy screen. When the Seal Check button is pressed on the Leak Alarm screen after the InfoV.A.C. Therapy Unit detects a possible leak.

31 21 How to Use Seal Check (When Starting Therapy) Pressing located on the Clinician Mode Home screen will immediately display this Therapy Start screen. Therapy Start Leak Rate High Log Exit Seal Check Tool Line on bar graph is the transition point from green to orange and vice-versa. Low Seal Audio Press to turn the Seal Audio tone On or Off leaks. 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 Where the V.A.C. Drape meets the skin. Where the SensaT.R.A.C. Pad is attached to the V.A.C. Drape. 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. 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. to return to the Clinician Mode Home screen.

32 22 Log Tool Overview Log Tool can be used to track the number of foam pieces used during a dressing change. Log Tool can be used to track canister changes. Logged information is viewable and exportable on the Therapy History screens. How to Use Log Tool (When Starting Therapy) on the Therapy Start screen opens this screen. Choose Canister or Dressing. Item to Log Exit Canister Dressing For dressing, also note the No. of foam pieces in patient chart and on drape returns to the Clinician Mode Home screen. accesses this Canister Replaced screen. Canister Replaced Press OK to log that the canister has been changed. (Will use the current time and date) Cancel OK logs that the canister has been replaced and returns to the Item to Log screen. The current time and date will be recorded. returns to the Item to Log screen without logging an entry.

33 23 accesses this screen. Information displayed represents the last logged entry. Number of Foam Pieces Press OK to log number of foam pieces and time/date 2 6 last recorded on 01 Feb :00 Cancel OK Use the buttons to change the number of pieces of foam used during the current dressing change. Press 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 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/mmm/yyyy Time Event 06/Jun/ :54 Canister Changed 06/Jun/ :55 Dressing Changed, 4 The numeral after Dressing Changed is the number of foam pieces recorded on the above screen.

34 24 Therapy Screen The Therapy Screen enables clinicians to change settings, select the wound type, check the seal and view the therapy or patient history. This screen is displayed when is pressed on the Clinician Home Screen. Therapy Exit Settings Setting Guide Seal Check Therapy History Patient History Manually set therapy. Guide for preset therapy settings. View or export therapy history. View or export patient history (via the Enter Access Code Screen).

35 25 Settings Screen (manual) This screen is displayed when Settings is pressed on the Therapy Screen. Exit Pressure Intensity Intermittent Change Pressure settings. Change Intensity. Toggle between and Intermittent therapy. Intensity Control Set Intermittent therapy times. From the Clinician Mode Home screen, press Therapy, then Next, then Settings to access the Intensity button. 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. 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. 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 :. Default setting is: Low.

36 26 Pressure Screen This screen is displayed when Pressure is pressed on the Settings Screen. Exit 125 mmhg Use the buttons change the negative pressure. Pressure can be set from 25 to 200 mmhg in increments of 25 mmhg. Press Exit to Default setting is: 125 mmhg Intermittent Screen Changing Intermittent time intervals will take effect in the next cycle. Intermittent Exit On Time Off Time 5 2 Minutes Minutes From the Clinician Mode Home screen, press Therapy, then press Settings, then press Intermittent to access this screen. Use the buttons to change the desired On and Off Time (in minutes). Both On and Off Times can be set from 1 minute to 10 minutes in 1 minute increments. Default setting is: On Time = 5 minutes. Off Time = 2 minutes.

37 27 Settings Confirmation Pressing Confirm Cancel Wound Type: Pressure: Mode: Intensity: Other 125 mmhg Low Back OK 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 therapy. to start

38 28 Settings Guide The Settings Guide tool helps the clinician select from pre-set therapy ranges according to wound type and treating physician s orders. Selected ranges are a guide based on common settings for different wound types. Individual patient conditions may vary. Consult physician to verify settings for each patient. Should physician orders fall outside the pre-set therapy ranges, select Other in this mode or use Manual Therapy Settings detailed earlier in the Clinician section of this manual. From the Clinician Mode Home screen, press Therapy, then Next, then Settings Guide and then OK to access this screen. Select Wound Type Cancel Other Back Next Use the buttons to scroll through the available wound type selections. Press Cancel on any screen to exit the procedure.

39 29 Select Pressure Within available range. Cancel 125 mmhg Back Next Use the buttons to scroll through the pressure selections. Pressure selections are in ranges for the wound type selected on the previous screen. Select Mode Cancel Back Next Use the buttons to choose or Intermittent Therapy. If Intermittent is not an option for the wound type selected, the mode will not change from continuous. Intermittent can be manually set from the Settings Screen, or press

40 30 If Intermittent Therapy was chosen on the previous screen, this screen will appear. Intermittent Cancel On Time Off Time 5 2 Minutes Minutes Back Next Use the buttons to change the desired On and Off Time (in minutes). Both On and Off Times can be set from 1 minute to 10 minutes in 1 minute increments. Default is: OnTime = 5 minutes. Off Time = 2 minutes. Settings Guide Confirmation Confirm Cancel Wound Type: Pressure: Mode: Intensity: Other 125 mmhg Low Back OK If the displayed settings are as desired, press OK to continue to the Therapy 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.

41 31 Seal Check Screen The Seal Check rate in the SensaT.R.A.C. system. This screen is displayed when is pressed on the Therapy Screen. Seal Check Leak Rate High Exit Low Seal Audio Press to enable / disable the audible representation. This tool can be used as an aid to ensure that the dressing system is correctly sealed. Therapy History Screen The Therapy History Screen displays the patients therapy information in date, time and event columns. The date is in ascending order and time is displayed using the twenty-four hour clock format. This screen is displayed when is pressed on the Therapy Screen. Therapy History Exit Date Sept Sept Sept Sept Sept Aug Time 09:34:18 09:40:12 14:46:49 14:16:48 14:15:44 14:17:31 Event Unit On Canister Changed Dressing Changed, 4 Canister Full Therapy Off Use the buttons to scroll to additional listed details. If wound history is recorded, see Patient History Screen for wound progress history. Press to return to the Therapy Screen.

42 32 Patient History Screens The Patient History screens enable a clinician to: Create a new access code. Start a new patient record. View the patient record. Delete the current patient record. Export history. View a wound image area graph. Analyze Wound Images. Enter Access Code Screen This screen is displayed when is pressed on the Therapy Screen. Enter Access Code Cancel (4 Char Max) **** Create Del 0 OK For security purposes, the InfoV.A.C. Therapy Unit will only allow one patient record at a time to be active. If a new access code is entered the current access code is overwritten and all patient history associated with it is deleted. All information will be automatically deleted when the unit is returned to For security purposes, if a current access code is incorrectly entered, access to the Patient History Screen will be denied and you will automatically be returned to the Therapy Screen. displayed in the Therapy Status and Display Area indicates that a Patient Record is active. Press after an existing code has been entered to proceed. Press to create a new access code. Press to be returned to the Therapy Screen. For security purposes, if an incorrect access code is entered 10 times,

43 33 Create a New Access Code Enter Access Code Cancel (4 Char Max) **** Create Del 0 OK For security purposes, the InfoV.A.C. Therapy Unit will only allow one patient record at a time to be active. If a new access code is entered the current access code is overwritten and all patient history associated with it is deleted. Press. Press the numbers on the screen keypad to enter your four digit numerical access code and press. Re-enter your four digit numerical access code. Press to set the new access code and proceed to the Change Patient ID Screen. Change Patient ID Screen A unique number is automatically generated from the date and time. Press to move the cursor left. Display area. Change Patient ID (Use stylus on keys) Exit < _ > <- Q W E R T Y U I O P CAP A S D F G H J K L OK Z X C V B N M,. Press to move the cursor right. Press to delete the unique number displayed and enter a Patient ID of your choosing. Space Bar Enter the new Patient ID. Press when you have entered the new Patient ID, or are ready to proceed. Press If no changes are made, the automatically generated number will be used as the Patient ID. The entered Patient details are accepted and the Patient History Screen is displayed.

44 34 Patient History Menu Screen The Patient History Menu Screen will only be displayed after the access code has successfully been entered and accepted by the InfoV.A.C. Therapy Unit. Patient History Exit View History Delete History Export History View Graph Alarm Adjust Imaging opens the Patient History Screen where Patient History can be viewed and notes can be added. opens the Export Patient History Screen where the Patient History and Therapy History can be exported. opens the Graph Screen showing a graphical representation of measured wound area over time. opens the Alarm Adjust Screen where the settings of the Leak Alarm can be adjusted. opens the Imaging Screen to view and perform Wound Image Analysis.

45 35 View History Screen The Patient History Screen will display short notes added by the clinician Patient History Exit Add Note Date Time Event 12 Mar :12:30 Infection Clear 12 Mar :12:00 12 Mar :12:51 12 Mar :11:00 Infected New Dressing Healing Mar :12:40 Healing 12 Mar :12:00 Wound Dressed Press to open the Add Note to History Screen. Press to move the cursor left. Display area. Space Bar Add Note to History (Use stylus on keys) < CAP <- Q W E R T Y U I O A S D F G H J K L Z X C V B N M, P. Exit > Add Note Press to move the cursor right. Press to delete characters. Press to return to the Patient History Screen displaying the new note entered. Use the screen keys to enter a note (up to 30 characters). Press to return to the Patient History Screen. The entered patient details are accepted and the Patient History Screen is displayed.

46 36 Delete History Screen This screen is displayed when is pressed on the Patient History Screen. Deleted History cannot be recovered. Delete History Attention To delete current patient history press Delete. Once deleted, the data cannot be recovered. Press Cancel to abort delete history operation. Cancel Delete Press and hold for two seconds to delete the Patient History Records. After the Patient History Records have been deleted, the screen will return to the Patient History Screen. Press to return to the Patient History Screen without deleting Patient History. All information will be automatically deleted when the unit is returned to

47 37 Export Patient History Screen The exported Patient History contains folders for the Therapy History, the Patient History and all wound images for the current patient. Export Patient History Exit Export to USB Export to Memory Card Export to IR Data is exported with allocated filename. This screen is called up when is pressed on the Patient History Screen. created during the imaging process. opens the Memory Card Transfer Screen. opens the IR Transfer Screen. opens the USB Transfer Screen. Memory Card Slot USB Data Port Infrared Data Port The connection ports are for clinician use only.

48 38 Memory Card Transfer Screen Memory Card Transfer Please insert memory card into the memory card slot located at the front of the InfoV.A.C. therapy unit then select Next Cancel Next The Memory Card Slot is for authorized Clinician access only. Insert the Memory Card into the InfoV.A.C. Therapy Unit Memory Card Slot. An audible click signals that the card is properly inserted. to continue. If the Memory Card has been inserted into the Memory Card Slot and the Memory Card Transfer Error Screen is displayed, this screen advises that Possible reasons for transfer error: Card not inserted correctly. Incorrect format card. No images in the system. A progress bar on the screen will indicate that the transfer is progressing. When the transfer is complete press to continue.

49 39 IR Transfer Screen IR Transfer Open data door on InfoV.A.C. therapy unit, place IR device in front of the IR window and select next Cancel Next The Infrared Data Port is for authorized Clinician access only. Open the Data Door and position the IR device in front of the InfoV.A.C. Aim the IR Data Port of the transfer device at the Infrared Data Port on the InfoV.A.C. Press to continue. The InfoV.A.C. will attempt to establish a connection with the transfer device, once the connection is established, the transfer will begin. If the InfoV.A.C. Possible reasons for transfer error: IR transfer device not lined up with InfoV.A.C. Infrared Data Port. IR transfer device IR port not active or not set to receiving mode. Lenses on IR device are damaged or obscured. A progress bar on the screen will indicate that the transfer is progressing. When the transfer is complete press to continue.

50 40 USB Transfer Screen Insert the USB device into the InfoV.A.C. Therapy Unit USB port. USB Transfer Place the USB memory device into the USB port located on the front of the V.A.C. device and press Next Cancel Next The USB port is for authorized Clinician access only. Only non-powered Press to continue. If the USB Device has been inserted into the USB port and the USB not be transfered. Possible reasons for transfer error: Device not inserted correctly. Incorrect type device connected. A progress bar on the screen will indicate that the transfer is progressing. When the transfer is complete, will appear on the screen, press the button to continue.

51 41 Graph Screen The graph displays a representation of image area over time. Graph Area (cm2) Measured Image Area Exit Sep 2006 Time (days) 30 Sep 2006 deleted. A graph cannot be constructed unless measurements of the image area have been previously saved in the patients history log. At least two measurements from different days are required (area of the image against time) for a graph to be constructed. Select Leak Alarm Threshold Screen Select Leak Alarm Threshold Cancel High OK Use the buttons to select the level of alarm adjustment required. The InfoV.A.C. per minute), this screen allows the User to change that setting to Low (1 Liter per minute) when appropriate. Consult the clinician prescribing therapy before making changes to this setting. Press

52 42 Wound Image Analysis The Wound Imaging feature is an aid in helping to record treatment progress. Wound imaging area and volume calculation features are not intended and treatment of wounds. Accessories required to utilize this feature include: Digital camera with at least 2Mega pixel resolution. Digital camera that uses an SD/MMC card. An SD/MMC card. Calibration Reference Square. This is found on the ruler in the dressing package. This is needed for the InfoV.A.C. to calculate wound measurements. Stylus. This is found inside the Data Door. This is needed to aid in tracing. For optimal operation of the Wound Image Analysis feature it is recommended that: The sterile Calibration Reference Square should be placed in the same location on the wound each time an image is taken. All images be taken from directly above the wound. as possible. The image should be taken in good light conditions. Images must be taken directly from the camera, not transferred or downloaded to the card from a computer. Using a camera that has a date and time function will allow for easier

53 43 Imaging Screen Imaging Exit Select the device you want to view images from. USB VAC Memory Memory Card to select and view an image from the Memory Card. to select and view an image from a USB device. to select and view an image from the InfoV.A.C. Therapy Unit internal memory. There will be a short delay while the images are accessed from V.A.C. Memory or from the Memory Card. The relevant button will be highlighted with a green rim to indicate that this is in progress. When the InfoV.A.C. is ready, the File Select Screen will be displayed. If V.A.C.

54 44 File Select Screen File Select 1 of 20 Exit Image Thumbnail Select Image Filename filename.jpg Use the buttons to select the next or the previous image. Press when the required image is displayed. If this image is being opened from the memory card or from USB, it will be automatically downloaded into the InfoV.A.C. Therapy Unit internal memory. begins the Wound Area Trace procedure. begins the Wound Area Trace procedure. calculates the wound area inside the highlighted trace outline. begins the Wound Volume calculation procedure.

55 45 Image Reference Calibration Before measuring the image area and volume it is necessary to scale the image. This is done by tracing up the reference square in the image. screen to guide the user through the process begins the Calibration Reference process. Exit Calibration Reference Square Press highlighted button to mark up the reference sequare. Use only the stylus provided to trace the reference square. Touch each corner of the reference square. When the last corner of the reference square is touched the corner points will be joined by a highlighted line

56 46 Wound Area Trace The outline of the wound area should now be traced. begins the Wound Area Trace procedure. Select Image Area Select the image area you would like to trace. Image Area 1 Image Area 2 Image Area 3 to trace the overall outline of the wound area. All traces and results for Image Area 1 will be displayed in yellow to trace another area inside the wound. All traces and results for Image Area 2 will be displayed in blue. to trace an additional area. The InfoV.A.C. Therapy Unit only stores the area and depth of Image Area 1 in the Patient Log. It is the information in the Patient Log which is used to construct a graph. When selected, the Image will be displayed as a full screen with the buttons and status bar removed. begins the Wound Area Trace procedure. calculates the Wound Area inside the highlighted trace outline. begins the Wound Volume calculation procedure.

57 47 Draw around the required area with the stylus. A square will appear at the start point. The trace is completed when the end of the line returns to the start point. If an error is made, tap the stylus in the square at the start point. This action will return you to the previous screen where you can select to retrace the area. When the outline of the wound image area is complete, the buttons will reappear. If required, press to trace additional areas. calculates the wound area inside the highlighted trace outline. The results will be displayed in the colour of the trace for the appropriate measured area.

58 48 Calculate Wound Volume The wound volume can be calculated from the areas previously traced and the measured depth. begins the Wound Volume calculation procedure. Select Image Area for Depth Select the image area you would like to calculate the volume. Image Area 1 Image Area 2 Image Area 3 to enter the depth of Image Area 1. to enter the depth of Image Area 2. to enter the depth of Image Area 3. Enter Image Area Depth Exit cm Del. 0 OK Enter the image depth using the screen keys. The InfoV.A.C. Therapy Unit only stores the area and depth of Image Area 1 in the Patient Log. It is the information in the Patient Log which is used to construct a graph.

59 49 Clinician Utilities From the Clinician Mode Home screen, press Utilities to access this screen. Utilities Exit Brightness Time/Date Region 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 adjust regional settings Set the Brightness of the Touch Screen User Interface. The green crescent at the bottom of the button indicates the level of Brightness: Low :. Medium :. High :. The Default setting is Medium Press Exit to return to the Clinician Home screen. Changing Time and Date Set Time/Date Exit Year Month Day Hour(24) Minute From the Clinician Mode Home screen, press Utilities then press Time/Date to access this screen. Use the buttons to set current local time and calendar date. Holding these buttons will rapidly scroll through available selections. Press Exit to return to the Utilities screen.

60 50 Changing Pressure Units and Date Format From the Clinician Mode Home screen, press Utilities then press Region Settings to access this screen. Region Settings Exit DD/MMM/YYYY Date Format cm Units mmhg Pressure Units 1234,5 Number Format Language Pressing Pressure Units switches between mmhg (millimeters of Mercury) and kpa (kilo-pascals) units of measurement. Pressing Number Format changes how decimals are displayed. Pressing Units switches between cm (centimeters) and in (inches) Pressing Language changes the language the screens are displayed in. Pressing Date Format switches between displaying DD/MMM/YYYY (Day-Month- Year) and MMM/DD/YYYY (Month-Day-Year) formats. Default settings are: mmhg, DD/MMM/YYYY, cm and English. Press Exit to return to the Utilities screen.

61 51 Alerts and Alarms Alert Condition An Alert will be displayed on the Touch Screen User Interface when the InfoV.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. Alarm Condition An Alarm will be displayed on the Touch Screen User Interface when the InfoV.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 to silence the audible tone for two minutes. If alarm conditions cannot be resolved, contact KCI (see back cover). Index of Alerts and Alarms Alert Condition...51 Alarm Condition...51 Battery Low Alert...52 Battery Critical Alarm...52 Canister Full Therapy Interrupted Alarm...53 Canister Not Engaged Alarm...54 Leak Alarm...55 Leak Alarm Therapy Interrupted...56 Blockage Alert...57 Blockage Alarm Therapy Interrupted...57 Low Pressure Alert...58 Low Pressure Alarm Therapy Interrupted...58 Therapy Inactive Alarm...59 System Error Alarm Therapy Interrupted...59 Internal Temperature Alarm...60 Service Timer Expired Alert...60 Pressure Deviation Therapy Interrupted...61

62 52 Battery Low Alert This alert screen appears approximately two hours before the battery power level is too low to support continued operation of the InfoV.A.C. Therapy Unit. This alert will be accompanied by a single audible tone. Battery Low Alert Battery low, charge required. Audio Pause Reset To resolve this alert: Press? for more information Connect therapy unit to wall outlet using InfoV.A.C. Power Supply to recharge battery. An Amber light above the Power Socket will indicate charging is underway. Refer to the Battery Charging section of this manual for more information. Press Exit on this screen to return to the Home Screen. V.A.C. Therapy continues. This alarm screen appears approximately thirty minutes before the battery power level is too low to support continued operation of the InfoV.A.C. Therapy Unit. This alarm will be accompanied by a repeating audible tone. This alarm may be silenced during troubleshooting by pressing Audio Pause. Battery Critical Battery critically low, charge immediately. Audio Pause Press? for more information To resolve this alarm: 1. Connect therapy unit to wall outlet using InfoV.A.C. Power Supply to recharge battery. An Amber light above the Power Socket 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. 3. Reset 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 one minute, therapy will be interrupted.

63 53 Canister Full Therapy Interrupted Alarm This alarm screen appears when the InfoV.A.C. Therapy Unit detects that the canister is full and should be replaced. This alarm will be accompanied by a repeating audible tone. This alarm may be silenced for two minutes during troubleshooting by pressing Audio Pause. Canister Full Therapy Interrupted Press eject and replace canister, then press Reset. WARNING: Replace V.A.C Dressing with alternate dressing if therapy remains off for more than two hours. Audio Pause Press? for more information Therapy Off To resolve this alarm: 1. Graduated Marks on the canister. Reset 500 ml canister 1000 ml canister If canister is not full after checking level, press. 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. 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.

64 54 Canister Not Engaged Alarm This alarm screen appears when the InfoV.A.C. Therapy Unit detects that the canister is not fully seated and properly latched. This alarm will be accompanied by a repeating audible tone. This alarm may be silenced for two minutes during troubleshooting by pressing Audio Pause. Canister Not Engaged Ensure canister is in place. Audio Pause Reset Press? for more information Therapy Off To resolve this alarm: Remove the canister by pressing the Canister Release button. Inspect the canister and InfoV.A.C. Therapy Unit to ensure no foreign objects or debris interfere with the canister and therapy unit s mating surfaces Ensure both Seals are present. If seals are missing or damaged, contact KCI. Re-attach the canister to the InfoV.A.C. Therapy Unit ensuring that the canister is fully engaged and latched. An audible click indicates that the canister is properly installed. 5. Press Reset on this screen to return to the Home Screen. 6. Restart therapy by pressing. If this alarm continues to appear, repeat steps 1 through 6 with a new canister. Otherwise, if 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. Seals