ACTIV.A.C. Owner Service Manual Rev A Feb 2018

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Table Of Contents Introduction / About This Manual... 3 Preparation For Use... 3 Unpack The Unit... 3 Initial Inspection... 3 Unit Features... 4 Serial Number Location... 5 Cleaning and Disinfection... 5 Infection Control... 5 Supplies and Equipment Needed... 5 General Cleaning Recommendations... 5 Therapy Unit... 6 Power Supply... 7 Fabric Carrying Case... 7 Service Procedures... 8 Parts and Equipment Needed... 8 Inspect Unit for Damage... 8 Replace Exhaust Filter... 9 Data Download... 9 Battery Check... 10 Battery Change... 11 Pressure Checks... 13 • Set-up... 13 • 25 mmHg Test... 14 • 125 mmHg Test... 14 • 200 mmHg Test... 15 • 125 mmHg Test ... 16 Charge Battery and 6 Hour Unit Verification Test... 17 Verify Time and Date... 20 Alarm Tests... 20 • Leak Alarm... 20 • Blockage Alert... 21 • Canister Not Engaged and Check Battery Level... 22 • Canister Full Therapy Interrupted... 22 Final Settings... 23 Recharge Battery... 23 Preparation for Transport and Patient Use... 24 On-Premises Use... 24 • Supplies needed:... 24 • Preparation For Use... 24 Off-Premises Use... 25 • Supplies needed:... 25 • Preparation For Use... 25 Specifications... 26 Spare Parts ... 27 Symbols Used... 28 Service Manual... 28 Therapy Unit... 28 Contact Information... 28 ActiV.A.C.® Therapy System Required Service Record... Inside Back Cover

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DISCLAIMER OF WARRANTY AND LIMITATION OF REMEDY KCI HEREBY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ON THE KCI PRODUCT(S) DESCRIBED IN THIS PUBLICATION EXCEPT FOR THE WRITTEN LIMITED WARRANTY INCLUDED WITH THIS 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 (see page 28) for updates.

Important Information For Users This manual contains routine service procedures for the ActiV.A.C.® Therapy Unit sold by KCI. This manual is not intended for repair or non-routine service procedures. Contact KCI (see page 28) for any repair or non-routine service not covered by this manual. Please read and understand all sections of this manual before beginning any service procedures on this equipment. In order for KCI products to perform properly, KCI recommends the following. Failure to comply with these conditions will void any applicable warranties. • Assembly, operations, extensions, re-adjustments, modifications, service or repairs must be performed by qualified personnel authorized by KCI. • Access codes to engineering screens are proprietary and remain property of KCI, and may only be used for the limited purpose as outlined in KCI copyrighted documentation. • The electrical installation of the room must comply with the appropriate national electrical wiring standards. • Use this product only in accordance with its user manual and applicable product labeling. • Ensure that personnel performing the procedures detailed in this manual are properly trained and qualified to perform service on medical devices. • Follow all procedures as outlined in this manual, including infection prevention and control and care and cleaning. • Document and retain as a permanent record all service procedures performed. • Use only KCI V.A.C.® Dressings and accessories with this product.

Notice This product has been configured from the manufacturer to meet specific voltage requirements. Refer to the Product Information Label for specific voltage.

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 ActiV.A.C.® Therapy Unit and also included in every V.A.C.® Dressing carton. Please consult the ActiV.A.C.® Therapy Unit User Manual and Safety Information Sheet before applying V.A.C.® Therapy. If there are questions or these documents are missing, immediately contact your local KCI representative.

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Introduction / About This Manual This manual is designed to assist with routine service procedures for the ActiV.A.C.® Therapy Unit sold by KCI. Following these procedures ensures that the ActiV.A.C.® Therapy Unit is properly cleaned, fully functional and ready for patient use. These procedures include: • Unpacking and initial unit inspection • Cleaning and disinfection • Inspection for damaged and/or missing parts • Verifying unit function • Ensuring battery is fully charged • Verifying default settings are correct All steps in these procedures must be followed in the order presented to provide proper functionality and reliability of the ActiV.A.C.® Therapy Unit. Opening the therapy unit to gain access to the internal components (other than the battery) may void the warranty. Each ActiV.A.C.® Therapy Unit must be cleaned, disinfected, inspected and charged between each patient use. For further questions about the required frequency of service procedures, contact KCI (see page 28). It is recommended that all sections of this manual be reviewed before beginning any routine service procedures on the ActiV.A.C.® Therapy Unit. Please follow all applicable warnings and cautions and use standard precautions where necessary.

Preparation For Use Preparing the ActiV.A.C.® Therapy Unit for use includes unpacking, inspection for any damaged or missing parts, and an initial round of service procedures to ensure the battery is fully charged and the unit is ready for patient use. The following procedures should be performed when the unit is first received from KCI.

Unpack The Unit 1. Inspect the cardboard shipping box to ensure there are no visible signs of damage. 2. Unpack all items from the shipping box. 3. Inspect all items for damage. If damage is noted, contact the shipping company for reporting/return procedures. 4. Inventory all items in shipping box against the packing slip. Contact KCI (see page 28) if there are any items missing.

Initial Inspection The purpose of this inspection is to ensure the unit has arrived without any internal damage and that the battery is fully charged prior to the initial patient placement. 1. Obtain the ActiV.A.C.® Therapy System Required Service Record form and fill in the required information for the unit in the spaces provided (see ‘Serial Number Location’ below). Form may be obtained either way as follows: • Locate and make photocopies of the form in the back of this manual. • Contact KCI (see page 28) to order a 25-pack of these forms. Ask for KCI part number 340141. 2. Perform the required service procedures as listed on the form. Start with ‘Inspect Unit For Damage’ on page 8 of this manual. 3. After initial inspection and service are complete, retain the completed form for each unit as a permanent record.

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Unit Features

Pump Port Wound Port Canister Seals

Touch Screen

Exhaust Filter Battery Cover

Canister Stabilization Grommets Power On/Off Button Note: The compliance label and the manufacturer information and serial number label are located on the back of the unit.

Infrared Data Port

Logo Label

Manufacturer Service Port

USB Data Port Battery Charging Indicator LED Battery Charging/ Power Connection

Mains Power Cord No bathing or showering

Power Supply

Tripping Hazard

Tripping Hazard

Power Cord Warning Label

No bathing or showering

Battery Charging/ Power Connector

5 Serial Number Location The ActiV.A.C.® has a serial number label, illustrated at right, that is located on the back of the unit. This serial number will be recorded on the ActiV.A.C.® Therapy System Required Service Record form.

Serial Number SERIAL NUMBER BAR CODE

*VFSRXXXXX* MFG DATE BAR CODE REORDER CODE: 340020

MODEL: ACTIVAC

YYYY-MM 340394 REV A

Cleaning and Disinfection Cleaning and disinfection of the ActiV.A.C.® Therapy Unit includes wipedown of all hard surface components. The ActiV.A.C.® Therapy Unit must be cleaned and disinfected: 1. If it becomes soiled during patient use. 2. Between each patient use.

Infection Control Institutional policies regarding infection control may vary; however, KCI recommends the following regarding infection control when processing KCI V.A.C.® Therapy devices: • Designate ‘contaminated’ and ‘clean’ areas for separating and storing equipment before and after transport, cleaning and disinfection. Follow protocols to ensure no cross-contamination occurs between unclean and clean units. • Use personal protective equipment (PPE) and hand hygiene protocols in accordance with the following standards: • 29 CFR 1910.1030, OSHA Bloodborne Pathogens Standard • MMWR October 2002;51 (No. RR-16), Guidelines for Hand Hygiene in Healthcare Settings • Clean all organic material from the therapy unit prior to disinfection. • Use hospital-grade cleaners and disinfectants, according to the CDC 2008 Guideline for Disinfection and Sterilization in Healthcare Facilities. • Do not immerse or saturate the therapy unit with fluids to avoid damage to the electronics in the device. Follow institutional procedures used for the cleaning and disinfection of other hard surface durable electronic medical equipment. 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.

Supplies and Equipment Needed • Hospital grade antiseptic used per label directions • Clear plastic bags (as appropriate) • Cotton tipped applicators • Rubber bands • Tweezers or similar tool • #1 Phillips screwdriver

General Cleaning Recommendations • Use PPE as appropriate. • For items that are wiped down, ensure item’s entire surface is completely covered with the cleaning fluid and remains wet for a minimum of 60 seconds.

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Therapy Unit 1. Remove the unit from the plastic and/or fabric carrying case, as applicable. 2. Ensure therapy unit is unplugged from power supply. 3. Remove canister seals from unit. Wipe/clean seals with antiseptic. Ensure the seal cavities and adjacent surfaces are clean of any foreign material. Replace seals when finished. Canister Seals

4. Remove the Exhaust Filter. Discard the filter using local protocols. Moisten a cotton tipped applicator with antiseptic; thoroughly wipe the interior of the filter compartment. Exhaust Filter The Exhaust Filter is single use only.

5. Wipe down the back of the unit with antiseptic. Do not allow excess cleaning fluid into the areas surrounding the Touch Screen Gasket. 6. When wiping the front of the unit, do not allow cleaning fluid to seep into any gaps in the Touch Screen Gasket. Three such typical areas are pointed out in the illustrations below. Cleaning fluids allowed to seep past the gasket may damage the Touch Screen to the point of requiring replacement.

7 7. Wipe down the front and sides of the unit with antiseptic. 8. Once the unit is thoroughly cleaned, allow to air dry. 9. Place the clean unit in a clear plastic bag and move to the service area.

Power Supply

No bathing or showering Tripping Hazard

Tripping Hazard

No bathing or showering

1. Ensure the power supply is unplugged from the therapy unit and/or any power source. 2. Wipe the power supply and cord with antiseptic. Allow to air dry. 3. Inspect the power supply ‘brick’, cords and connectors for damage and cracked or exposed wiring. Contact KCI if replacement is necessary. 4. Inspect the power supply safety labels for legibility. Replace as necessary. 5. Loosely loop the power cord and secure with a rubber band. 6. Place the clean power supply in a clear plastic bag and move it to the service area.

Fabric Carrying Case The ActiV.A.C.® Fabric Carrying Case (KCI P/N 340122) is designed as a single use item; do not launder or reuse.

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Service Procedures The following service procedures are used to verify that the ActiV.A.C.® Therapy Unit is functioning properly and that the battery is fully charged. Once these procedures are complete, the unit will be ready for patient use. These procedures should be performed as listed and in order: 1. When the unit is first received from KCI, as part of the initial inspection (starting at ‘Inspect Unit for Damage’). 2. Between each patient use. All service should occur in a clean area that is protected from contamination from unclean units or other potential contamination sources. Use PPE as appropriate or as specified in local protocols.

Parts and Equipment Needed • ActiV.A.C.® Canister KCI P/N M8275058, two (2) each • These are normal ActiV.A.C.® canisters that can be reused for up to 6 months as a test canister. KCI recommends marking the canister with ‘Test Canister-Not For Human Use’ and the in-use date. • Tubing Cap, KCI P/N M6275069, one (1) each. Note: A tubing cap is attached to the canister tubing as delivered. • ActiV.A.C.® Therapy System Required Service Record form, KCI P/N 340141, one (1) each • Canister Seal, KCI P/N 340040, two (2) each (if required) • Exhaust Filter, KCI P/N 340037, one (1) each • ActiV.A.C.® Fabric Carrying Case KCI P/N 340122, one (1) each • ActiV.A.C.® Pressure Accuracy Accessory, KCI P/N 340145, one (1) each • Calibrated Digital Manometer, customer supplied, one (1) each. Manometer accuracy to be within 2.5 mmHg.

Inspect Unit for Damage The purpose of this procedure is to inspect the ActiV.A.C.® unit for damage using the following criteria: 1. Examine the unit top, bottom and sides for: • Cracks of any size. • Holes of any size that expose internal components. 2. Examine the canister attachment area for: • Cracks of any size • Damage to the canister seals • Missing or damaged canister stabilization grommets

Battery History Label

Canister Seals

Canister Stabilization Grommets 3. Examine the battery charging/power connection and USB data port to ensure they are clear with no visible bent pins or other obstructions. 4. Examine the touch screen area and ensure it is secure in the case. 5. Check for excessive screen scuffing, scratches and/or cracks that could obscure screen elements. Deep or extensive screen scratches or cracks can be the source of intermittent erratic therapy unit operation.

USB Data Port

Battery Charging/ Power Connection

9 ActiV.A.C.® Logo Label 6. Verify all labels are present per illustrations on pages 8 and 9. 7. Inspect all labels for readability. If replacement is necessary, see spare parts list and apply new label over old.

Labels for the ActiV.A.C.® unit are designed to be nonremovable by patients during normal use. If a label becomes damaged, DO NOT use a sharp object to scrape the label off. The powder coating on the unit may be damaged beyond repair. Apply new label in the same position and orientation as the original. The label manufacturer recommends NOT using any cleaning fluid or other cleaning material to remove any residual label adhesive. 8. Should the unit fail any of the above criteria, contact KCI (see page 28). 9. With the unit inspection complete, continue on to ‘Replace Exhaust Filter’.

ActiV.A.C.® Compliance Label

Replace Exhaust Filter The purpose of this procedure is to replace the exhaust filter. This procedure can be skipped if the unit is new and has not been previously placed with a patient. 1. Insert a new exhaust filter. 2. Ensure the filter is fully seated. 3. With the Exhaust Filter replacement complete, continue on to ‘Data Download’.

Data Download

Clinician Mode 6 Aug 2009 15:06

The purpose of this procedure is to download and archive the therapy history file from the most recent use of the ActiV.A.C.® unit. This procedure can be skipped if the unit is new and has not been previously placed with a patient. If a problem occurs with therapy and you would like assistance diagnosing the problem, please contact KCI (see page 28). KCI recommends therapy history file be downloaded and saved as a permanent digital record filed by unit serial number and download date. 1. Ensure the unit powered on and is in Clinician Mode. If the unit is in Patient Mode, press ‘?’, then press ‘Clinician Mode’, then press and hold ‘OK’ until the mode changes. 2. Press ‘Therapy’. 3. Press ‘Next’. 4. Press ‘History’. 5. Press ’Export History’. 6. Press ‘Export to USB’.

On/Off

Utilities

Therapy Continuous Therapy Off 0mmHg

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Always use a USB Flash Drive. Do not plug a USB PC cable into the ActiV.A.C.® Therapy Unit. 7. Insert a USB Flash Drive into the USB Data Port.

8. Press ‘Next’. 9. Wait while the unit downloads the data to the Flash Drive. 10. When the download is complete, Press ‘OK’. • If System Errors 2 through 6 occur, power the unit off and back on and try again. • System Errors 7 and 8 are cleared by resetting patient defaults, see Final Settings section. • If the error recurs, contact KCI (see page 28). • If System Error 1 occurs, contact KCI (see page 28). 11. Press ‘Exit’ to return to the Clinician Home Screen. 12. Remove the USB Flash Drive from the ActiV.A.C.® unit. 13. Connect the USB Flash Drive to an external computer. The ActiV.A.C.® unit exports a file folder that uses the unit serial number as its name. The folder contains a Comma Separated Values (CSV) file named by date, YYYYMMDD.csv. 14. For the initial save operation, save the entire file folder to a secure computer. 15. For subsequent data exports from the same ActiV.A.C.® unit, save the new dated CSV file to the same secure computer into the existing folder named with the ActiV.A.C.® unit serial number. 16. With the Data Download complete, continue on to ‘Battery Check’.

Battery Check The purpose of this procedure is to determine if the battery needs changing. 1. Locate the Battery History label located on the bottom of the unit. 2. Verify the battery change date on the battery history label. 3. If the battery is within the date range, skip ahead to ‘Pressure Checks’; otherwise proceed to the ‘Change Battery’ procedure.

11 Battery Change The purpose of this procedure is to change the battery. Ensure that the ActiV.A.C.® unit is not connected to the power supply when removing or replacing the battery.

Battery History Label

1. Verify that the Battery Change Due date on the Battery History label is at or exceeds the current date. 2. Remove the Battery History Label. 3. Using a #1 Phillips screwdriver, remove the two 4-40 Phillips head screws.

Screws

4. Remove the battery cover.

5. Remove the battery from the unit until the wiring connector is accessible.

Battery Connector

12 6. Disconnect the battery from the unit. 7. Remove the old battery and dispose of it properly in accordance with local, state and federal regulations for Lithium-ion (Li-ion) batteries. The ActiV.A.C.® Therapy Unit battery must be replaced only with batteries supplied by KCI. Use of any other battery may compromise safety and/or cause erratic operation. 8. Obtain a new battery from KCI (KCI P/N 340079). 9. Obtain a new Battery History Label (KCI P/N 340168). Shelf life of the battery is 12 months from battery manufacture date. Verify that the battery manufacture date is within 12 months of the date of installation. If the manufacture date is outside 12 months, contact KCI (see page 28) for a replacement battery. 10. Calculate the next ‘Battery Change Due’ date as 18 months from the installation date. 11. Record the required information on the Battery History label. 12. Slide new battery about halfway into unit until connectors meet. Plug connectors together and ensure locking tabs are fully engaged. 13. Fit the battery into the housing ensuring the wiring harness is on the front side of the battery and NOT behind and is otherwise not tangled or obstructing fitting the battery fully into the battery compartment. 14. Press the Power On/Off switch to ensure the unit powers on properly. 15. Press the Power On/Off switch to turn the unit off. 16. Fit the battery cover, ensuring that it easily fits and does not need to be forced into place. If force is required, the battery is not properly installed. Double check that the wiring harness is not preventing the battery from fitting fully into the battery compartment. 17. Install the two (2) screws tightly. 18. Install the new Battery History Label across the battery cover. 19. With the Battery Change complete, continue on to ‘Pressure Check’.

Battery History Label

Screws

Pressure Checks The purpose of this procedure is to ensure the therapy unit pump responds to pressure setting adjustments. The ActiV.A.C.® Therapy Unit MUST be connected to the ActiV.A.C.® power supply during this procedure. The needle valve simulates the permeability of a V.A.C.® Drape. The PVC test fixture and hygroscopic filter simulates the ActiV.A.C.® canister.

Set-up 1. Remove the Silicone Canister Interface Seals from the unit.

Seals Removed

13 2. Connect the PVC test fixture to the ActiV.A.C.® unit as illustrated below.

Hygroscopic Filter connected to Pump Port ActiV.A.C.® Unit PVC Test Fixture Connected to Power Supply

Needle Valve Power On/Off Switch 3. Ensure the calibrated manometer is connected as illustrated and powered on.

Customer Supplied Calibrated Manometer

Hygroscopic Filter connected to Pump Port

Plain tubing connected to Wound Port 4. Ensure the tubing with the hygroscopic filter is connected to the pump port and the plain tubing is connected to the wound port. 5. Ensure the ActiV.A.C.® Power Supply is plugged into mains power and is also plugged into the ActiV.A.C.® unit. Power the unit on by pressing the power on/off switch for two seconds.

14 6. After acknowledging the warning screen, ensure the ActiV.A.C.® unit is in Clinician Mode by observing the text in the upper right hand corner of the screen, as illustrated. 7. If not in Clinician Mode, press ‘?’, press ‘Clinician Mode’, press and hold ‘OK’ until the screen changes to Clinician Mode.

Clinician Mode 6 Aug 2009 15:06

25 mmHg Test

Pressure

1. Press ‘Therapy’. 2. Press ‘Next’. 3. Press ‘Settings’. 4. Press ‘Pressure’ and use the arrow keys to set the pressure to 25. 5. Press ‘Exit two (2) times. 6. On the Confirm screen, ensure that settings are Pressure: 25 mmHg; Mode: Continuous; Intensity: Low. If these settings are not correct, press ‘Back’ to change the incorrect setting.

25 mmHG

Exit

+ _

Continuous Therapy Off 0 mmHg

7. Press ‘OK’. 8. Start therapy by pressing ‘On/Off’, the ‘Therapy Start’ screen will appear.

Confirm Pressure: Mode: Intensity:

25 mmHg Continuous Low

Back

OK Continuous Therapy Off 0 mmHg

9. Adjust the needle valve so that the Leak Rate bar graph indicator on the ‘Therapy Start’ screen indicates green and is below the dividing line on the bar graph, see illustration. 10. Observe the digital manometer and the displayed pressure on the ActiV.A.C.® Touch Screen. 11. The digital manometer should stabilize and indicate the pressure displayed touch screen, ± 10 mmHg. 12. Press ‘Exit’. 13. Press ‘Therapy’. 14. Press ‘Next’. 15. Press ‘Settings’.

125 mmHg Test

Therapy Start

Exit

Leak Rate High

Log

Seal Audio Low Continuous Therapy On 25 mmHg

Pressure

Exit

1. Press ‘Pressure’ and use the arrow keys to set the pressure to 125. 2. Press ‘Exit two (2) times. 125 mmHG

Continuous Therapy Off 0 mmHg

+ _

15 3. On the Confirm screen, ensure that settings are Pressure: 125 mmHg; Mode: Continuous; Intensity: Low. If these settings are not correct, press ‘Back’ to change the incorrect setting. 4. Press ‘OK’.

Confirm Pressure: Mode: Intensity:

125 mmHg Continuous Low

Back

OK Continuous

5. Press ‘Therapy’. 6. Press ‘Next’. 7. Press ‘Seal Check™. 8. Adjust the needle valve so that the Leak Rate bar graph indicator on the ‘Therapy Start’ screen indicates green and is below the dividing line on the bar graph, see illustration. 9. Observe the digital manometer and the displayed pressure on the ActiV.A.C.® Touch Screen. 10. The digital manometer should stabilize and indicate the pressure displayed touch screen, ± 10 mmHg. 11. Press ‘Exit’ one (1) time. 12. Press ‘Settings’.

Therapy Off 0 mmHg

Seal Check™

Exit

Leak Rate High

Seal Audio Low Continuous Therapy On 125 mmHg

200 mmHg Test

Pressure

Exit

1. Press ‘Pressure’ and use the arrow keys to set the pressure to 200. 2. Press ‘Exit two (2) times. 200 mmHG

+ _

Continuous Therapy Off 0 mmHg

3. On the Confirm screen, ensure that settings are Pressure: 200 mmHg; Mode: Continuous; Intensity: Low. If these settings are not correct, press ‘Back’ to change the incorrect setting. 4. Press ‘OK’.

Confirm Pressure: Mode: Intensity:

200 mmHg Continuous Low

Back

OK Continuous Therapy Off 0 mmHg

16 5. Press ‘Therapy’. 6. Press ‘Next’. 7. Press ‘Seal Check™’. 8. Adjust the needle valve so that the Leak Rate bar graph indicator on the ‘Therapy Start’ screen indicates green and is below the dividing line on the bar graph, see illustration. 9. Observe the digital manometer and the displayed pressure on the ActiV.A.C.® Touch Screen. 10. The digital manometer should stabilize and indicate the pressure displayed touch screen, ± 10 mmHg. 11. Press ‘Exit’. 12. Press ‘Settings’.

Seal Check™

Exit

Leak Rate High

Seal Audio Low Continuous Therapy On 200 mmHg

125 mmHg Test

Pressure

Exit

1. Press ‘Pressure’ and use the arrow keys to set the pressure to 125. 2. Press ‘Exit two (2) times. 125 mmHG

+ _

Continuous Therapy Off 0 mmHg

3. On the Confirm screen, ensure that settings are Pressure: 125 mmHg; Mode: Continuous; Intensity: Low. 4. Press ‘OK’. 5. Observe the digital manometer and the displayed pressure on the ActiV.A.C.® Touch Screen. 6. The digital manometer should stabilize and indicate the pressure displayed touch screen, ± 10 mmHg, within 60 seconds. 7. If the ActiV.A.C.® Therapy Unit passes all four (4) pressure change procedures, remove the test fixture tubing and reinstall the Silicone Canister Interface Seals on the unit. 8. Should the ActiV.A.C.® Therapy Unit fail any one of these pressure changes by not displaying the correct pressure within 60 seconds, contact KCI (see page 28). 9. With the Pressure Check complete, continue on to ‘Charge Battery and Six Hour Verification Test’.

Confirm Pressure: Mode: Intensity:

125 mmHg Continuous Low

Back

OK Continuous Therapy Off 0 mmHg

17 Charge Battery and Six Hour Unit Verification Test The purpose of this procedure is to ensure the ActiV.A.C.® unit is fully functional and the battery is fully charged. This six hour test is a minimum time. The process can be extended overnight or over a weekend if necessary. 1. Set the unit in a secure place where it can be left for a minimum of six hours. Charging can extend longer than six hours if necessary. 2. Plug the power supply cord into the ActiV.A.C.® unit. 3. Plug the mains power cord into the external power supply ‘brick’. 4. Plug the mains power cord into a grounded AC mains wall socket. 5. Verify the Battery Charging Indicator LED is lit.

An amber light means the battery is charging. A green light means the battery is fully charged.

Battery charging in-process Battery charging complete

6. Ensure the unit is powered on. If necessary, hold down the Power On/ Off button for a minimum of two seconds to power the unit on. 7. Once the unit has completed its power on self test, verify the ‘plug’ icon is present on the lower left of the touch screen.

Clinician Mode 6 Aug 2009 15:06

On/Off

Utilities

Therapy Continuous Therapy Off 0mmHg

‘Plug’ Icon 8. Unplug the power supply cord from the ActiV.A.C.® unit. Verify the ‘battery’ icon is present on the lower left of the touch screen.

Clinician Mode 6 Aug 2009 15:06

On/Off

Utilities

Therapy Continuous Therapy Off 0mmHg

‘Battery’ Icon

18

On/Off

9. Plug the power supply cord into the ActiV.A.C.® unit. Verify the ‘plug’ icon reappears and the Battery Charging Indicator LED is lit. 10. Grasp the power cord approximately 3” (75mm) from the end plugged into the ActiV.A.C.® unit and ‘wiggle’ the cord. Observe both the Battery Charging Indicator LED and the ‘plug’ icon on the touch screen. Should either of these indicators flicker, repeat the wiggle test using a different power supply cord. 11. Should the ActiV.A.C.® unit fail any of the above steps, contact KCI (see page 28).

Utilities Continuous Therapy Off 0mmHg

12. Attach a regular ActiV.A.C.® 300 mL canister that has been designated a ‘test canister’ to the ActiV.A.C.® unit. 13. Ensure that a tubing cap is attached to the canister tubing.

14. With the ActiV.A.C.® unit still in Clinician Mode,

Clinician Mode 6 Aug 2009 15:06 15. Press ‘Therapy’. 16. Press ‘Next’. 17. Press ‘Settings’. 18. Press ‘Pressure’ and if necessary use the arrow keys to set the pressure to 125. 19. Press ‘Exit two times.

Pressure

125 mmHG

Exit

+ _

Continuous Therapy Off 0 mmHg

20. On the Confirm screen, ensure that settings are Pressure: 125 mmHg; Mode: Continuous; Intensity: Low. If these settings are not correct, press ‘Back’ to change the incorrect setting. 21. Press ‘OK’.

Confirm Pressure: Mode: Intensity:

125 mmHg Continuous Low

Back

OK Continuous Therapy Off 0 mmHg

19 22. Start therapy by pressing ‘On/Off’, the ‘Therapy Start’ screen will appear. 23. Ensure the Leak Rate indicator is green. 24. Press ‘Exit’ to return to the Clinician Mode Home screen.

Therapy Start

Exit

Leak Rate High

Log

Seal Audio Low Continuous Therapy On 125 mmHg

25. KCI recommends starting a timer to ensure the six hour time period is achieved. 26. Press ‘On/Off’ to stop therapy. 27. At the end of the six hour verification period, carefully check the unit for: • Control buttons not responding • Excessively hot unit • No alarms are displayed

Clinician Mode 6 Aug 2009 15:06

On/Off

Utilities

Therapy Continuous Therapy On 125mmHg

On/Off

28. Verify that the Battery Charging Indicator LED is lit and showing green.

Utilities 29. Unplug the power supply cord from the ActiV.A.C.® unit. 30. Verify the ‘battery full’ icon appears. 31. Should the unit fail any of the above criteria, contact KCI (see page 28). 32. With the ‘Charge Battery and Six Hour Verification Test’ complete, continue on to ‘ Verify Time and Date‘.

Th Continuous Therapy Off 0mmHg