V.A.C. Ultra User Manual for Clinicians Rev A

Important Safety Information Accompanies This Device Indications, Contraindications, Warnings, Precautions and other Safety Information are contained in the 3M™ V.A.C.® Ulta Negative Pressure Wound Therapy System (3M™ V.A.C.® Ulta Therapy System) Safety Information. This safety information booklet is provided with the 3M™ V.A.C.® Ulta Negative Pressure Wound Therapy Unit (3M™ V.A.C.® Ulta Therapy Unit) and also included in 3M™ V.A.C. Veraflo™ Dressing cartons. Please consult this 3M™ V.A.C.® Ulta Therapy System User Manual and the safety information before applying 3M™ V.A.C.® Therapy or 3M™ V.A.C. Veraflo™ Therapy. Before applying 3M™ Prevena™ Therapy or 3M™ AbThera™ Therapy, consult the safety information and instructions for use provided in 3M™ Prevena™ and 3M™ AbThera™ Dressing cartons. If there are questions, or if the safety information is missing, immediately contact your local service support representative. Additional product information can be found at www.veraflo.com or www.vaculta.com (US); or HCBGregulatory.3M.com (global). 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. Please report a serious incident in relation to the device to KCI USA, Inc., now a part of 3M and the local competent authority (EU) or local regulatory authority. 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 3M HEREBY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, ON THE 3M PRODUCT(S) DESCRIBED IN THIS PUBLICATION. ANY WRITTEN WARRANTY OFFERED BY 3M SHALL BE EXPRESSLY SET FORTH IN THIS PUBLICATION OR INCLUDED WITH THE PRODUCT. UNDER NO CIRCUMSTANCES SHALL 3M 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 3M TO ANY REPRESENTATION OR WARRANTY EXCEPT AS SPECIFICALLY SET FORTH IN THIS PARAGRAPH. Descriptions or specifications in 3M 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 your service support for updates.

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Table of Contents Important Safety Information Accompanies This Device... 3 Warnings: Important Information For Users...11 Colors Used in this Manual...11 Introduction...13 3M™ V.A.C.® Ulta Therapy System Key Features and Benefits...16 3M™ V.A.C.® Ulta Therapy Unit Component Identification...18 Alert and Alarm Symbols...20 Preparation for Use...23 Charge Battery...23 Therapy Unit Placement...25 Attaching the Therapy Unit to an I.V. Pole...26 Attaching the Therapy Unit to a Bed Footboard...27 Attaching the 3M™ V.A.C. Veralink™ Cassette...28 Attaching Solution Bag / Bottle...29 Solution Container Hanger Arm Extension...30 Hang Solution Bag / Bottle...31 Connect Instillation Line...32 Canister Installation...33 Changing the Canister...35 Operation...37 Touch Screen...37 3M™ V.A.C.® Ulta Therapy System - Therapy Options...38 Touch Screen - Tabs...40 Common Touch Screen Buttons...41 Power the 3M™ V.A.C.® Ulta Therapy Unit On or Off...42 New Patient Screen...43 3M™ V.A.C. Veraflo™ Therapy - Setup Options...44 3M™ V.A.C. Veraflo™ Therapy Configuration - 3M™ Smart Instill™ Feature Settings Overview...45 3M™ V.A.C. Veraflo™ Therapy Configuration - Fill Assist Settings Overview...46 3M™ V.A.C. Veraflo™ Therapy Configuration - Advanced User Defined Settings Overview...47 Configure 3M™ V.A.C. Veraflo™ Therapy - 3M™ Smart Instill™ Feature Setup...48 3M™ Smart Instill™ Feature - 3M™ Seal Check™ Leak Detector...49 5

3M™ Smart Instill™ Feature - Confirm Settings Screen...52 3M™ V.A.C. Veraflo™ Therapy - Secondary Setup...54 3M™ Smart Instill™ Feature - Manual Setup...55 Confirm Settings Screen...56 3M™ Smart Instill™ Feature - Instillation Paused Screen...58 Configure 3M™ V.A.C. Veraflo™ Therapy - Advanced User Defined Settings...59 Confirm Settings Screen...60 Fill Assist Screens...61 Home Screen - 3M™ V.A.C. Veraflo™ Therapy...63 Information Screens - 3M™ V.A.C. Veraflo™ Therapy...64 Stop 3M™ V.A.C. Veraflo™ Therapy Confirmation...65 3M™ V.A.C. Veraflo™ Therapy Paused / Postpone...65 3M™ V.A.C. Veraflo™ Therapy Pause...66 3M™ V.A.C. Veraflo™ Therapy Pause - Resume Therapy...67 Confirm Postponement...68 Instillation Postponed - Resume Therapy...69 3M™ V.A.C. Veraflo™ Therapy Alerts and Alarms...71 3M™ V.A.C. Veraflo™ Therapy Blockage Alert...72 3M™ V.A.C. Veraflo™ Therapy Blockage Alarm (Therapy Interrupted)...73 3M™ V.A.C. Veraflo™ Therapy Canister Full Alarm (Therapy Interrupted)...74 3M™ V.A.C. Veraflo™ Therapy Canister Not Engaged Alarm...75 3M™ V.A.C. Veraflo™ Therapy Therapy Inactive Alarm...76 3M™ V.A.C. Veraflo™ Therapy Leak Alarm...77 3M™ V.A.C. Veraflo™ Therapy Leak Alarm (Therapy Interrupted)...78 3M™ V.A.C. Veraflo™ Therapy Low Pressure Alarm (Therapy Interrupted)...79 3M™ V.A.C. Veraflo™ Therapy 3M™ V.A.C. Veralink™ Not Engaged Alert...80 3M™ V.A.C. Veraflo™ Therapy Solution Bag / Bottle Empty Alert...81 3M™ Smart Instill™ Feature Inactive Alert: Setup Incomplete...82 3M™ Smart Instill™ Feature Inactive Alert: Instillation Paused...83 3M™ V.A.C. Veraflo™ Therapy Fill Assist Inactive Alert...84 3M™ V.A.C. Veraflo™ Therapy Pressure Deviation Alarm (Therapy Interrupted)...85 3M™ V.A.C. Veraflo™ Therapy Instill Tube Blockage Alert (Therapy Interrupted)...86 3M™ V.A.C. Veraflo™ Therapy Battery Low Alert...88 3M™ V.A.C. Veraflo™ Therapy Battery Critical Alarm...89 6

Battery Exhausted Alarm...90 3M™ V.A.C. Veraflo™ Therapy Internal Temperature Alert...91 3M™ V.A.C. Veraflo™ Therapy System Error Alarm (Therapy Interrupted) (after Power On)...92 System Error Alarm (at Power On)...93 Utilities Tab - 3M™ V.A.C. Veraflo™ Therapy...94 Dressing Soak with Therapy Inactive Alarm Delay ...95 Therapy Inactive Alarm Delayed...99 Test Cycle...100 3M™ V.A.C.® Therapy Configuration - Default Settings Overview...101 3M™ V.A.C.® Therapy Configuration - Advanced User Defined Settings Overview...102 3M™ V.A.C.® Therapy Settings Screen...103 Confirm Settings...104 Home Screen - 3M™ V.A.C.® Therapy...105 Information Screens - 3M™ V.A.C.® Therapy...106 3M™ V.A.C.® Therapy Alerts and Alarms...107 3M™ V.A.C.® Therapy Blockage Alert...108 3M™ V.A.C.® Therapy Blockage Alarm (Therapy Interrupted)...109 3M™ V.A.C.® Therapy Canister Full Alarm (Therapy Interrupted)...110 3M™ V.A.C.® Therapy Canister Not Engaged Alarm...111 3M™ V.A.C.® Therapy Therapy Inactive Alarm...112 3M™ V.A.C.® Therapy Leak Alarm...113 3M™ V.A.C.® Therapy Leak Alarm (Therapy Interrupted)...114 3M™ V.A.C.® Therapy Low Pressure Alarm (Therapy Interrupted)...115 3M™ V.A.C.® Therapy 3M™ V.A.C. Veralink™ Not Engaged Alert...116 3M™ V.A.C.® Therapy Solution Bag / Bottle Empty Alert...117 3M™ V.A.C.® Therapy Pressure Deviation Alarm (Therapy Interrupted)...118 3M™ V.A.C.® Therapy Instill Tube Blockage Alert (Therapy Interrupted)...119 3M™ V.A.C.® Therapy Battery Low Alert...120 3M™ V.A.C.® Therapy Battery Critical Alarm...121 Battery Exhausted...122 3M™ V.A.C.® Therapy Internal Temperature Alert...123 3M™ V.A.C.® Therapy System Error Alarm (Therapy Interrupted) (after Power On)...124 System Error Alarm (at Power On)...125 Utilities Tab - 3M™ V.A.C.® Therapy...126 7

Dressing Soak...127 3M™ Prevena™ Therapy Configuration - Overview...129 Home Screen - 3M™ Prevena™ Therapy...130 Information Screens - 3M™ Prevena™ Therapy...131 3M™ Prevena™ Therapy Alerts...133 3M™ Prevena™ Therapy Blockage Alert...134 3M™ Prevena™ Therapy Blockage Alert (Therapy Interrupted)...135 3M™ Prevena™ Therapy Canister Full Alert...136 3M™ Prevena™ Therapy Canister Not Engaged Alert...137 3M™ Prevena™ Therapy Therapy Inactive Alert...138 3M™ Prevena™ Therapy Leak Alert...139 3M™ Prevena™ Therapy Battery Low Alert...140 3M™ Prevena™ Therapy Battery Critical Alert...141 Battery Exhausted...142 3M™ Prevena™ Therapy Internal Temperature Alert...143 3M™ Prevena™ Therapy System Error Alert (Therapy Interrupted) (after Power On)...144 System Error Alert (at Power On)...145 Utilities Tab - 3M™ Prevena™ Therapy...146 3M™ AbThera™ Therapy Overview...147 Confirm Settings Screen - 3M™ AbThera™ Therapy ...148 Home Screen - 3M™ AbThera™ Therapy...149 Information Screens - 3M™ AbThera™ Therapy...150 3M™ AbThera™ Therapy Alerts...151 3M™ AbThera™ Therapy Blockage Alert...152 3M™ AbThera™ Therapy Blockage Alert (Therapy Interrupted)...153 3M™ AbThera™ Therapy Canister Full Alert...154 3M™ AbThera™ Therapy Canister Not Engaged Alert...155 3M™ AbThera™ Therapy Therapy Inactive Alert...156 3M™ AbThera™ Therapy Leak Alert...157 3M™ AbThera™ Therapy Battery Low Alert...158 3M™ AbThera™ Therapy Battery Critical Alert...159 Battery Exhausted...160 3M™ AbThera™ Therapy Internal Temperature Alert...161 3M™ AbThera™ Therapy System Error Alert (Therapy Interrupted) (after Power On)...162 8

System Error Alert (at Power On)...163 Utilities Tab - 3M™ AbThera™ Therapy...164 3M™ Seal Check™ Leak Detector Overview...165 3M™ Seal Check™ Leak Detector - 3M™ V.A.C. Veraflo™ Therapy...166 3M™ Seal Check™ Leak Detector - 3M™ V.A.C.® Therapy...167 3M™ Seal Check™ Leak Detector - 3M™ Prevena™ Therapy...168 3M™ Seal Check™ Leak Detector - 3M™ AbThera™ Therapy...169 Log - 3M™ V.A.C. Veraflo™ Therapy...170 Log - 3M™ V.A.C.® Therapy...171 Log - 3M™ Prevena™ Therapy...172 Log - 3M™ AbThera™ Therapy...173 History Tab Screen...175 Patient History or Imaging Configuration (First Time Use) - Overview...176 Patient History or Imaging Configuration (New Access Code) - Overview...177 Patient History...178 Create New Patient History...178 Access Patient History...179 Create New Access Code...180 Patient History Screen...182 View Patient History Screen...183 Export Patient History Screen...184 View Graph - Wound Area (cm2) Screen...185 Delete Patient History Screen...186 Wound Imaging...187 Imaging Screen...188 Analyzing Images - Touch Corners of Reference Square...191 Analyzing Images - Trace Wound Perimeter...192 Analyzing Images - Image Area Depth...194 Delete Images...195 Therapy History Screen...197 Alarm History Screen...198 Export History Screen...199 Data Transfer Errors...200 Utilities Tab...201 9

Regional Settings Screen...202 About and Contact Information Screen...203 Screen Calibration Screen...204 Date & Time Settings Screen...206 Screen Brightness Screen...207 Leak Alarm Threshold Screen...208 Confirm Serial Number...209 Care and Cleaning...211 Standard Precautions...211 Waste Disposal...211 Cleaning the 3M™ V.A.C.® Ulta Therapy Unit...211 Cleaning the Touch Screen...212 Explanation of Symbols Used...213 Specifications...215 Electromagnetic Compatibility...217 Customer Contact Information...221

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Warnings: Important Information For Users In order for 3M products to perform properly, 3M recommends the following conditions. Failure to comply with these conditions will void any applicable warranties. •

Use this product only in accordance with this manual and applicable product labeling.

•

Assembly, operations, extensions, re-adjustments, modifications, technical maintenance or repairs must be performed by qualified personnel authorized by 3M. For these authorized personnel, 3M will make available upon request circuit diagrams, component parts lists, etc. as required for repairs.

•

Ensure the electrical installation of the room complies with the appropriate national electrical wiring standards. To avoid the risk of electrical shock, this product must be connected to a grounded power receptacle.

•

Do not operate this product if it has a damaged power cord, power supply or plug. If these components are worn or damaged, contact your service support.

•

Do not drop or insert any object into any opening or tubing of this product.

•

Do not connect this product or its components to devices not recommended by 3M.

•

Use only 3M™ V.A.C.® Dressings, 3M™ V.A.C. Veraflo™ Dressings, 3M™ Prevena™ Dressings or 3M™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressings and associated disposables with this product.

•

Keep this product away from heated surfaces.

•

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 3M.

•

Avoid spilling fluids on any part of this product.

•

Do not use this product while bathing / showering or where it can fall or be pulled into a tub, shower or sink.

•

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 your service support.

•

Do not use this product in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide, or an oxygen enriched environment.

•

Do not take this product into an MR environment. This product is MR Unsafe.

Notice - This product has been configured from the manufacturer to meet specific voltage requirements. Refer to the product information label for specific voltage.

Colors Used in this Manual Screen Button / Screen name - Screen names and Screen Buttons. 3M™ V.A.C.® Therapy - Items and information that relate specifically to 3M™ V.A.C.® Therapy. 3M™ V.A.C. Veraflo™ Therapy - Items and information that relate specifically to 3M™ V.A.C. Veraflo™ Therapy.

3M™ AbThera™ Therapy - Items and information that relate specifically to 3M™ AbThera™ Therapy. 3M™ Prevena™ Therapy - Items and information that relate specifically to 3M™ Prevena™ Therapy. System - Items and information that relate specifically to the 3M™ V.A.C.® Ulta Therapy Unit.

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Warning and Important Information for Users

Fluids 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. 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 your service support.

Introduction The 3M™ V.A.C.® Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides: •

3M™ V.A.C.® Negative Pressure Wound Therapy (1)

•

3M™ V.A.C. Veraflo™ Instillation Therapy (2)

•

3M™ Prevena™ Incision Management Therapy (3)

•

3M™ AbThera™ SensaT.R.A.C.™ Open Abdomen Therapy (4).

Refer to the 3M™ V.A.C.® Ulta Negative Pressure Wound Therapy System (3M™ V.A.C.® Ulta Therapy System) Safety Information that accompanies the 3M™ V.A.C.® Ulta Therapy Unit for complete Indications for Use for each of these therapies and safety and use information. 3M™ V.A.C.® Negative Pressure Wound Therapy (with two negative pressure modes):

1 3M™ V.A.C.® Therapy (continuous)

Dynamic Pressure Control™

Target Negative Pressure

25 - 200 mmHg

25 mmHg 0 mmHg

Target Negative Pressure

50 - 200 mmHg

25 mmHg 0 mmHg

3M™ V.A.C.® Dressings are available for use with the 3M™ V.A.C.® Therapy option by the 3M™ V.A.C.® Ulta Therapy System. Additional dressings specific to 3M™ V.A.C. Veraflo™ Therapy are also available.

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3M™ V.A.C. Veraflo™ Instillation Therapy:

2

Phases of 3M™ V.A.C. Veraflo™ Therapy (Start Phase: Instill)

Draw Down*

Instill Fluid

Soak

3M™ V.A.C.® Therapy**

Cycle repeats for duration of therapy

* 3M™ Seal Check™ Leak Detector ** Continuous and Dynamic Pressure Control™ Therapy negative pressure modes are available with 3M™ V.A.C. Veraflo™ Therapy. 3M™ V.A.C. Veraflo™ Dressings are available for use with the 3M™ V.A.C. Veraflo™ Therapy option provided by the 3M™ V.A.C.® Ulta Therapy System. 3M™ Prevena™ Incision Management Therapy:

Mode

Negative Pressure Profile 125 mmHg

Continuous 0 mmHg

3M™ Prevena™ Dressings are available for use with the 3M™ Prevena™ Therapy option provided by the 3M™ V.A.C.® Ulta Therapy System.

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3M™ AbThera™ SensaT.R.A.C.™ Open Abdomen Therapy:

Mode

Negative Pressure Profile Target

100 - 150 mmHg

Continuous 0 mmHg

The 3M™ AbThera™ Dressing is available for use with the 3M™ AbThera™ Therapy option provided by the 3M™ V.A.C.® Ulta Therapy System. The 3M™ V.A.C.® Ulta Negative Pressure Wound Therapy System is intended to be operated by qualified clinical caregivers in the acute care setting. In-service and training programs for use of 3M™ V.A.C.® Therapy, 3M™ V.A.C. Veraflo™ Therapy, 3M™ Prevena™ Incision Management Therapy and 3M™ AbThera™ Open Abdomen Therapy are available. Therapy unit information signals should be monitored by the clinical caregiver. Patients are not expected to apply or change dressings or adjust therapy unit settings.

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3M™ V.A.C.® Ulta Therapy System Key Features and Benefits Therapy Selection - Allows user to select 3M™ V.A.C. Veraflo™, 3M™ V.A.C.®, 3M™ Prevena™ or 3M™ AbThera™ Therapies. 3M™ Smart Instill™ Feature (3M™ V.A.C. Veraflo™ Therapy) - Is an automated feature that performs 3M™ Seal Check™ Leak Detector, estimates and instills a volume of topical wound fluid which will saturate the applied dressing within 12 hours of 3M™ V.A.C. Veraflo™ Therapy initiation. Following initial fluid instillation, the user will have time to evaluate the amount of fluid instilled into the wound and will have the ability to adjust therapy parameters. Instillation volume is targeted to saturate the dressing. Fill Assist (3M™ V.A.C. Veraflo™ Therapy)- Allows the user to monitor the initial wound fill by manually starting and stopping instillation to determine the appropriate instill volume after the dressing is applied. Once determined, this volume will be the set point for each future instill phase of 3M™ V.A.C. Veraflo™ Therapy. Benefits: •

Removes the guesswork related to volume setting.

•

Helps reduce leaks caused by wound overfilling.

Volumetric Delivery with Solution Dwell Time (3M™ V.A.C. Veraflo™ Therapy) - The 3M™ V.A.C.® Ulta Therapy Unit provides unique and patented volumetric fluid delivery utilizing a pump. Benefits: •

Delivers fluid reliably and uniformly across wound bed.

•

Allows time for solubilizing infectious materials and wound debris.

Automated and Cyclic Wound Cleansing (3M™ V.A.C. Veraflo™ Therapy) - 3M™ V.A.C. Veraflo™ Therapy is 100% automated after set-up, providing hands-free, repeating wound cleansing cycles through instillation of topical wound solutions. Benefits: •

Delivers automatic and repetitive topical wound cleansing without dressing removal.

•

Eliminates need for manual wound cleansing between dressing changes.

3M™ V.A.C. Veralink™ Cassette (3M™ V.A.C. Veraflo™ Therapy) - This disposable component connects the 3M™ V.A.C.® Ulta Therapy Unit to the solution bag / bottle and dressing tubing.

3M™ V.A.C.® Ulta Therapy System Key Features and Benefits

Benefits: •

It provides convenient solution storage and delivery.

Dressing Soak (3M™ V.A.C.® Therapy and 3M™ V.A.C. Veraflo™ Therapy) - This tool allows the clinician to soak the dressing and the wound with instillation solution in preparation for a dressing change, and temporarily delay the therapy inactive alarm up to 60 minutes. Benefits:

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•

Provides ability to help "float" the dressing by increasing instillation volume and soak time.

•

Moistens and softens the dressing for easier removal and patient comfort.

•

Allows for dressing changes to occur with less frequent interruptions.

Additional Features Touch Screen User Interface: The touch screen user interface allows for easy navigation through operational and help menus. A screen guard is available to help prevent unintentional changes. A settings lock is available to prevent patient access to therapy settings. Adjustable Negative Pressure Settings and Therapy Modes: Settings can be selected from a range of 25 mmHg to 200 mmHg in increments of 25 mmHg depending on settings available for selected therapy. In addition, 3M™ V.A.C.® Therapy and 3M™ V.A.C. Veraflo™ Therapy can be set for continuous negative pressure or Dynamic Pressure Control™ Therapy. 3M™ Seal Check ™ Leak Detector: This tool assists the user in finding negative pressure leaks in the system through the use of audible tones and on-screen visual aids during the troubleshooting process. History Reports: The 3M™ V.A.C.® Ulta Therapy System provides three possible reports: 1. Alarm History, 2. Therapy History, and 3. Patient History. These chronologically logged reports include the date and times for therapy starts / stops, therapy settings, alarm occurrences, and disposable component changes. They can be reviewed on-screen or transferred electronically from the 3M™ V.A.C.® Ulta Therapy Unit via a non-powered USB Drive or SD card. 3M™ SensaT.R.A.C.™ Technology: The 3M™ SensaT.R.A.C.™ Technology (also incorporated in the 3M™ V.A.C. VeraT.R.A.C.™ Pad, 3M™ V.A.C. VeraT.R.A.C. Duo™ Tube Set, 3M™ Prevena™ Plus Incision Management System, and 3M™ AbThera™ 3M™ SensaT.R.A.C.™ Open Abdomen Dressing System) monitors and maintains target pressure at the wound site, helping to deliver consistent therapy. This system includes therapy unit hardware and software, wound exudate collection canister, canister detection method, multi-lumen tubing, connector and 3M™ SensaT.R.A.C.™ Pad. Not available with the 3M™ Prevena™ Dressing without 3M™ SensaT.R.A.C.™ Pad. In-Line Tubing Connectors: The system incorporates an in-line dressing connector and tubing clamps to conveniently allow the wound dressing to be temporarily disconnected from the therapy unit. Canisters: The 3M™ V.A.C.® Ulta Therapy Unit is optimized for use with 500 mL or 1000 mL canisters. The 500 and 1000 mL are the same canisters used with INFOV.A.C.™ Therapy Unit. Canisters are single use, manufactured without natural rubber latex, sterile components. Canister Release Button: The canister release button is illuminated and will flash when the canister is full. Intensity Setting: Intensity is related to the time it takes to reach the target negative pressure therapy level after the initiation of therapy. The lower the intensity setting, the longer it will take to reach the target negative pressure. Wound Image Analysis: Digital wound images can be uploaded from a digital camera into the 3M™ V.A.C.® Ulta Therapy Unit. When the wound perimeter is traced on-screen with the provided stylus, wound image surface area and volume can be calculated and trended by the therapy unit. 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 3M™ V.A.C.® Ulta Therapy Unit electronically. This information is intended to be used by the treating clinician as a mechanism for providing a record of wound healing progress; it is not intended for use in the diagnosis and treatment of wounds. Hanger Mechanism: The therapy unit can be securely mounted to an I.V. pole, a bed footboard or a wheelchair. Battery Operation: In order to facilitate patient transfer, battery operation is available with the 3M™ V.A.C.® Ulta Therapy Unit. During typical usage, the battery may provide up to six hours of operation before needing to be recharged.

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3M™ V.A.C.® Ulta Therapy Unit Component Identification

Power Button

Canister Release Button

Touch Screen

Unit Serial Number Label

Battery Changing Indicator Light Speaker USB Port SD Card Slot

Stylus

3M™ V.A.C.® Ulta Therapy Unit - Front

3M™ V.A.C.® Ulta Therapy Unit Component Identification

Solution Container Hanger Arm

Unit Hanger Knob

Solution Container Hanger Arm Lock

Unit Hanger Arm

3M™ V.A.C.® Ulta Therapy Unit - Back 18

Instillation Tubing Retention Groove Carry Handle

Solution Container Hanger Arm Lock Instill Pump

3M™ V.A.C. Veralink™ Cassette Pivot Slot

3M™ V.A.C.® Ulta Therapy Unit - Left

Canister Bellows (Seals)

3M™ V.A.C.® Ulta Therapy Unit Power Connection

3M™ V.A.C.® Ulta Therapy Unit - Right 19

Alert and Alarm Symbols Alert / Alarm

3M™ V.A.C. Veraflo™ Therapy

3M™ V.A.C.® Therapy

3M™ Prevena™ Therapy

3M™ AbThera™ Therapy

ALERT

ALERT

ALERT

ALERT

ALARM

ALARM

ALERT

ALERT

ALARM

ALARM

ALERT

ALERT

ALARM

ALARM

ALERT

ALERT

ALARM

ALARM

ALERT

ALERT

ALARM

ALARM

ALERT

ALERT

ALARM

ALARM

ALARM

ALARM

3M™ V.A.C. Veralink™ Not Engaged

ALERT

ALERT

Solution Bag / Bottle Empty

ALERT

ALERT

Blockage*

Blockage (Therapy Interrupted)*

Canister Full

Canister Not Engaged*

Therapy Inactive

Leak*

Leak (Therapy Interrupted)*

Alert and Alarm Symbols

Low Pressure

3M™ Smart Instill™ Feature Setup Incomplete

ALERT

3M™ Smart Instill™ Feature Instillation Paused

ALERT

3M™ V.A.C. Veraflo™ Fill Assist Inactive

ALERT

* On screen help with troubleshooting techniques. 20

Alert / Alarm Symbol 3M™ V.A.C. Veraflo™ Pressure Deviation

3M™ V.A.C. Veraflo™ Instill Tube Blockage (Therapy Interrupted)*

3M™ V.A.C. Veraflo™ Therapy

3M™ V.A.C.® Therapy

3M™ Prevena™ Therapy

3M™ AbThera™ Therapy

ALARM

ALARM

ALERT

ALERT

ALERT

ALERT

ALERT

ALERT

ALARM

ALARM

ALERT

ALERT

ALARM

ALARM

ALERT

ALERT

ALERT

ALERT

ALERT

ALERT

ALARM

ALARM

ALERT

ALERT

Battery Low

Battery Critical

Battery Exhausted

Internal Temperature ºC

System Error

* On screen help with troubleshooting techniques.

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Preparation for Use Charge Battery The 3M™ V.A.C.® Ulta Therapy Unit comes with its own power supply and a 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 3M™ V.A.C.® Ulta Therapy Unit. Use only the power supply provided with the 3M™ V.A.C.® Ulta Therapy Unit (part number: 4103730). Using any other power supply may damage the 3M™ V.A.C.® Ulta Therapy Unit. If environmental conditions (specifically, low humidity) pose a risk of static electricity, take care when handling the 3M™ V.A.C.® Ulta Therapy Unit while it is 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 your local service support. To isolate the therapy unit from supply mains, unplug the AC power cord from the wall outlet. Do not block access to the plug or wall outlet.

Preparation for Use

Power cords may present a tripping hazard. Ensure that all cords are out of areas where people may walk.

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1.

Plug the AC power cord into the DC power supply.

2.

Plug the AC wall plug into an AC wall outlet. DC power supply must remain accessible at all times to allow for immediate disconnect from power source, if necessary.

3.

Locate the arrow on the charging cord connector. The arrow should face up as the connector is plugged into the power connection on the 3M™ V.A.C.® Ulta Therapy Unit.

3M™ V.A.C.® UltaTherapy Unit Power Connection

Arrow

3M™ V.A.C.® Ulta Charging Cord Connector

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