Acelity KCI PREVENA User manual

PREVENA™
INCISION MANAGEMENT SYSTEM
PATIENT GUIDE
Rx Only

2
KCI Negative Pressure Wound Therapy Units for Use at Home with PREVENA™ Dressings
You may have been prescribed a V.A.C.ULTA™, INFOV.A.C.™ or V.A.C.RX4™
Therapy Unit while you were in the hospital.
However, these units are not for home use.
If you have been sent home with a V.A.C.ULTA™, INFOV.A.C.™ or V.A.C.RX4™
Therapy Unit, call your doctor right away and ask for one of the units shown
above.
IMPORTANT: V.A.C.ULTA™, INFOV.A.C.™ and V.A.C.RX4™ Therapy Units
NOT for Use at Home with PREVENA™ Dressings
PREVENA™ Dressings can be used with one of the KCI Therapy Units shown below:
For KCI V.A.C.® Therapy Unit Alerts and Alarms, see the user manual that comes with the therapy unit.
V.A.C. SIMPLICITY™ Therapy Unit
PREVENA™ 125 Therapy Unit ACTIV.A.C.™ Therapy Unit V.A.C. FREEDOM™ Therapy Unit
V.A.C.ULTA™ Therapy Unit INFOV.A.C.™ Therapy Unit V.A.C.RX4™ Therapy Unit

3
Contraindication and Warnings
You have been prescribed a PREVENA™ Dressing and a therapy unit to manage your incision. Please read this guide to learn more about these items and how to use them.
This guide also includes important warnings for your safety. Call your doctor or KCI at 1-800-275-4524 if you have any questions about the PREVENA™ Dressing or
therapy unit.
Contraindication
The dressing contains silver. If you are sensitive or allergic to silver, call your doctor right away.
Warnings
Do not wrap carrying case strap (if provided) or dressing tubing around neck.
Small Parts - Choking Hazard.
The therapy unit is a prescription medical device. Please read and follow all the instructions in this guide so the product can perform properly while in use.
If you need:
• Magnetic Resonance Imaging (MRI), your doctor or nurse must remove the therapy unit. The dressing can remain in place.
• Hyperbaric Oxygen Therapy (HBO), your doctor or nurse must remove the therapy unit and dressing.
If defibrillation is required, a doctor or nurse will decide if the dressing should be removed.
Bleeding
Some patients may be at risk of heavy bleeding, with or without using the prescribed therapy system. This bleeding can be caused by the type of surgical procedure or by certain
patient conditions.
If you see a large amount of blood near your incision or in the tubing or canister, leave the dressing in place. Turn off the therapy unit. Call your local emergency service (i.e. 911) right away.
Full Canister
The canister may fill up with fluid before your therapy is done. If you see a large amount of fluid (other than blood) in the canister, turn off the therapy unit. Call your doctor right away. The
therapy unit will let you know when the canister is full.
Infection
The following symptoms may mean that your incision is infected. Call your doctor right away if you:
Allergic Reaction
The dressing may cause an allergic reaction if you are sensitive to acrylic adhesives or to silver. The following symptoms may mean you are having an allergic reaction. Call your doctor right
away if you:
If you feel short of breath, your allergic reaction may be more serious. Call your local emergency service (i.e. 911) right away and turn off the therapy unit.
• have swelling at the dressing
• feel increase in soreness at the dressing
• have redness around the dressing
• feel feverish
• feel itching at the dressing
• feel warmth at the dressing
• have pus at the dressing
• have a bad odor at the dressing
• notice redness
• notice swelling
• develop a rash
• develop hives
• develop itching

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Check the appearance of the dressing regularly. See the PREVENA™ Incision Dressing Pressure Check section for more details. Do not turn off the therapy unit unless:
• your doctor instructs you
• you experience bleeding
• you have an allergic reaction
See the Warnings section of this guide for more details.
The dressing should only be applied or removed by or on the advice of your doctor.
Do not modify the therapy unit or dressing. Do not connect therapy unit or dressing to other devices that you might be using.
The therapy unit is a medical device that monitors pressure and is not a toy. Keep away from children, pets and pests as they can damage the dressing and therapy unit and affect
performance. Keep the therapy unit free of dust and lint as they can also cause damage and affect performance.
Cleaning
If needed, clean the therapy unit and carrying case (if provided) with a damp cloth and mild soap and water solution. Do not use bleach.
Bathing
• Bathing in tub is not recommended.
• Do not submerge the therapy unit or dressing.
Showering
• Quick showering is permitted if cleared with your doctor. Protect the therapy unit from direct spray of water. Avoid prolonged water contact with the therapy unit and
dressing.
• When towel drying, be careful not to disrupt or damage the dressing.
Sleeping
• Place the therapy unit in a position where the tubing will not become kinked or pinched.
• Make sure the therapy unit cannot be pulled off the table or dropped on the floor.
Strenuous Activity
Stay away from strenuous activity when using the therapy unit. Ask your doctor:
• how active you can be
• when you can resume your daily routine
Instructions for Use

5
If the therapy unit beeps, see the Indicators and Alerts section of this guide for more information.
Do not re-use any part of the PREVENA™ System. The therapy unit, canister and dressing are for single use only. Re-use of any part could cause wound contamination, infection or failure
to heal.
PREVENA™ 125 Therapy Unit
PREVENA™ 125 Therapy Unit Carrying Case
Battery Replacement
PREVENA™ Incision Dressing Pressure Check
Push here to slide open the battery cover.
Replace with AA size batteries. Lithium batteries
will last longer than regular batteries.
+
+
+
_
!
Use the adjustable strap to wear the carrying case over your shoulder
or across your chest. You can also wear the carrying case on your belt.
Do not wrap the carrying case strap or dressing tubing around neck.
Press the On/Off button to start the 192 hour (eight day) life cycle of the
therapy unit.
On/Off and Audio Pause Button:
Press once to mute audible alerts
for 60 minutes.
Audio Pause
Light
Low Battery
Light
Caution
Light
PREVENA™ 125 Therapy System
On/Off and Audio Pause Button: Push once to mute audible alerts.
Audio Pause/Mute Feature
See the Indicators and Alerts section for more details.
LEAK ALERT ALERT PAUSED
CANISTER FULL ALERT ALERT PAUSED
Mutes audible alert for eight hours.
Check the PREVENA™ Incision
Dressing section to see if therapy is
being applied or not.
Mutes audible alert for one hour.
LOW BATTERY ALERT ALERT PAUSED
SYSTEM ERROR ALERT ALERT PAUSED
Mutes audible alert for one hour.
Mutes audible alert for one hour.
To seal leaks:
• Use PREVENA™ Patch Strips (shown) for PEEL &
PLACE™ Dressing
• Use excess KCI Drape (not shown) for PREVENA™
CUSTOMIZABLE™ Dressing
When the dressing is not compressed, therapy is
not at the proper pressure. See the Indicators and
Alerts section for pressure check information.
Dressing Not Compressed
X
When the dressing is compressed, therapy is
being applied to the dressing.
Dressing Compressed
3

6
Indicators and Alerts
Therapy On / Off
ON / OFF AND AUDIO PAUSE BUTTON
TURN ON - Hold two seconds
TURN OFF - Hold five seconds
AUDIO PAUSE/MUTE - Press once to mute alerts
(See the Audio Pause / Mute Feature section.)
Green light shows
therapy is on.
See Leak Alert section below.
NO
Continue therapy. If alarming for leak,
see the Leak Alert section below.
YES
Dressing
Compressed?
Check for kinked or
pinched tubing.
See Leak Alert
section below.
Check for leaks.
PREVENA™ Incision Dressing Pressure Check
Alert Lights
Make sure canister is securely locked
and side tabs are flush with unit.
Continue therapy.
Use Audio Pause;
call KCI at 1-800-275-4524
YES
NO
one beep, one solid light
Check all connectors
for leaks. Use PREVENA™ Patch Strips or
excess KCI Drape to seal leak.
Leak Alert
fixed?
Leak Alert
YES
NO
two beeps, one solid light
See Warnings section.
Call KCI at 1-800-275-4524.
Full or
near full?
Check fluid level in canister.
Check for kinked or
pinched tubing.
Turn unit off.
See Therapy On/Off above.
Canister Full Alert
LOW - A slow beep and one solid light -
Be prepared to change batteries.
CRITICAL - A rapid beep and one solid
light - Change batteries right away. Three AA batteries required.
Lithium batteries recommended.
Hold five seconds
to TURN OFF.Hold two seconds
to TURN ON.
Press and push
to open panel.
Press and push
to close panel.
Low Battery Alert
Call KCI at 1-800-275-4524.
NO
Therapy
running?
Hold five seconds
to TURN OFF.
Continue therapy.
YES
Hold two seconds
to TURN BACK ON.
A repeated beep increasing in volume,
and two solid lights
System Error Alert
Three lights show life cycle is up. There will be a repeated beep for 15 seconds and then the unit will shut off.
Life cycle = 192 hours (eight days)
Call KCI at 1-800-275-4524.
Device Life Cycle Expired
Dressing Not
Compressed?
Press firmly around
dressing edge.
22
22

7
Environmental and Storage Conditions
Temperature Range: ....................................................................................-4˚F (-20˚C) to 140˚F (60˚C)
Relative Humidity Range: ..........................................................................15%-95%, non-condensing
Operating Conditions
Temperature Range: .......................................................................................41˚F (5˚C) to 104˚F (40˚C)
Atmospheric Pressure Range:................................................................ 1060 hpa (-1253 ft/-381.9 m)
(for optimum performance) to 700 hpa (9878 ft/3010 m)
Equipment not suitable for use in presence of flammable anesthetic mixture with air, oxygen or
nitrous oxide.
The PREVENA™ 125 Therapy Unit is classified as a Type BF applied part under IEC 60601-1.
IP24 - Protection against solid objects greater than 12.5mm and against liquid water sprays for
short periods of time.
All alerts are classified as low priority according to IEC 60601-1-8.
Conforms to IEC 60601-1, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-1-11.
Disposal
The therapy unit and dressing should be removed by your doctor. Do not discard these items
with household trash. This could violate local laws regarding hazardous waste.
Electrical Equipment Interference
Cell phones or similar products could affect the therapy unit. Move the therapy unit away from
these devices if interference is suspected.
Specifications
Symbols Used
PREVENA™ 125 Therapy System
Refer to Clinician Guide Fragile
Do Not Resterilize IP24 Ingress Protection
Date of Manufacture MR Unsafe
Single Use Only Type BF Applied Part
Consult Instructions for Use Keep Dry
Do not use if package is
damaged or open Sterile Using Radiation
Use By Authorized Representative in the
European Community
Manufacturer Content Information
Lot Number Catalog Number
Temperature Limits
This product is designated for separate collection at an appropriate collection point.
Do not dispose of as household waste.
Rx Only CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician.

All trademarks designated herein are proprietary to KCI Licensing, Inc., its affiliates and/or licensors. Copyright 2017 KCI Licensing, Inc. All rights reserved. 417419 Rev A 9/2017
Manufactured for:
KCI USA, Inc.
12930 IH 10 West
San Antonio, TX 78249 USA
1-800-275-4524
www.acelity.com
Contact Information
For questions about this product, supplies, maintenance or more information about KCI products and services, please contact KCI or a KCI authorized representative, or:
In the US call 1-800-275-4524 or visit www.acelity.com
KCI USA, Inc. 12930 IH 10 West, San Antonio, Texas, 78249
Outside the US visit www.kci-medical.com
Treating Physician: __________________________________________
Phone: ____________________________________________________

PREVENA™
SISTEMA DE TRATAMIENTO PARA INCISIONES
GUÍA PARA EL PACIENTE
Rx Only

10
Unidades de terapia de presión negativa para el tratamiento de heridas KCI de uso doméstico con apósitos PREVENA™
Mientras estuvo en el hospital, puede que le hayan prescrito una unidad de terapia
V.A.C.ULTA™, INFOV.A.C.™ o V.A.C.RX4™.
Sin embargo, estas unidades no están indicadas para el uso domiciliario.
Si le han dado de alta con una unidad de terapia V.A.C.ULTA™, INFOV.A.C.™ o V.A.C.RX4™,
llame a su médico de inmediato y consúltele sobre una de las siguientes unidades.
IMPORTANTE: Unidades de terapia V.A.C.ULTA™, INFOV.A.C.™ y V.A.C.RX4™
NO indicado para el uso doméstico con apósitos PREVENA™
Los apósitos PREVENA™ pueden utilizarse con cualquiera de estas unidades de terapia KCI:
Para alertas y alarmas de la unidad de terapia V.A.C.® de KCI, consulte el manual del usuario que viene con la unidad de terapia.
Unidad de terapia PREVENA™ 125 Unidad de terapia ACTIV.A.C.™ Unidad de terapia V.A.C. FREEDOM™
Unidad de terapia V.A.C. SIMPLICITY™
Unidad de terapia
V.A.C.ULTA™
Unidad de terapia
INFOV.A.C.™
Unidad de terapia
V.A.C.RX4™