KCI V.A.C.Via v.a.c.therapy Negative Pressure Wound Therapy... User manual

V.A.C.Via™
NEGATIVE PRESSURE WOUND
THERAPY SYSTEM
INSTRUCTIONS FOR USE
GEBRAUCHSANWEISUNG / GEBRUIKSAANWIJZING / MODE D’EMPLOI
ISTRUZIONI PER L’USO / INSTRUCCIONES DE USO / BRUGERVEJLEDNING
BRUKSANVISNING / INSTRUÇÕES DE USO / KULLANIM TALİMATLARI
ΟΗΓΙΕΣ ΧΡΗΣΗΣ / KÄYTTÖOHJEET / BRUKSANVISNING
V.A.C.Via™UNTERDRUCKWUNDTHERAPIE-SYSTEM
V.A.C.Via™NEGATIVE PRESSURE WOUND THERAPY SYSTEM
V.A.C.Via™SYSTÈME DE THÉRAPIE PAR PRESSION NÉGATIVE
V.A.C.Via™SISTEMA TERAPEUTICO A PRESSIONE NEGATIVA
V.A.C.Via™SISTEMA DE TERAPIA DE PRESIÓN NEGATIVA PARA EL TRATAMIENTO
DE HERDAS / V.A.C.Via™NEGATIVE PRESSURE WOUND THERAPY SYSTEM
V.A.C.Via™SÅRBEHANDLINGSSYSTEM MED NEGATIVT TRYCK
V.A.C.Via™SISTEMA DE TERAPIA DE LESÕES COM PRESSÃO NEGATIVA
V.A.C.Va™NEGATİF BASINÇ YARA TEDAVİ SİSTEMİ
V.A.C.Via™ΘΕΡΑΠΕΙΑ ΕΠΟΥΛΣΗΣ ΤΡΑΥΜΑΤΝ ΜΕ ΕΦΑΡΜΟΓΗ ΑΡΝΗΤΙΚΗΣ ΠΙΕΣΗΣ
V.A.C.Via™-ALIPAINEIMUHOITOJÄRJESTELMÄ
V.A.C.Via™SÅRBEHANDLINGSSYSTEM MED UNDERTRYKK


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V.A.C.Via™
NEGATIVE PRESSURE WOUND
THERAPY SYSTEM
(7-Day V.A.C.®THERAPY SYSTEM)
INSTRUCTIONS FOR USE
Keep Instructions for Use with Device
English


TABLE OF CONTENTS
V.A.C.® Therapy Safety Information 1
V.A.C.Via™ Therapy Unit 5
V.A.C.Via™ Dressing Application Instructions 6
V.A.C.Via™ Canister Installation 9
Beginning Therapy 10
Duration of Therapy 11
Leaks 12
Alarms 13
Battery 15
Important Information to Discuss with Patients 16
Symbols Used 19
Contact Information 20
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. ANY WRITTEN WARRANTY OFFERED BY KCI
SHALL BE EXPRESSLY SET FORTH IN THIS PUBLICATION OR INCLUDED WITH THE PRODUCT. UNDER
NO CIRCUMSTANCES SHALL KCI BE LIABLE FOR ANY INDIRECT, INCIDENTAL, OR CONSEQUENTIAL
DAMAGES AND EXPENSES, INCLUDING DAMAGES OR INJURY TO PERSON OR PROPERTY, DUE IN
WHOLE OR IN PART TO THE USE OF THE PRODUCT OTHER THAN THOSE FOR WHICH DISCLAIMER OF
WARRANTY OR LIMITATION OF LIABILITY IS EXPRESSLY PROHIBITED BY SPECIFIC,APPLICABLE LAW.
NO PERSON HAS THE AUTHORITY TO BIND KCI TO ANY REPRESENTATION OR WARRANTY EXCEPT AS
SPECIFICALLY SET FORTH IN THIS PARAGRAPH.
Descriptions or specifications in KCI printed matter, including this publication, are meant solely to
generally describe the product at the time of manufacture and do not constitute any express warranties
except as set forth in the written limited warranty included with this product. Information in this
publication may be subject to change at any time. Contact KCI for updates.


The V.A.C.Via™Therapy Unit is a single use, disposable V.A.C.®Therapy device designed for moderate to
low severity wounds.The V.A.C.Via™Therapy Unit has a 7-day lifespan and a rechargeable battery. This unit
provides negative pressure at either 75mmHg or 125mmHg, and offers selection of Continuous therapy or
Dynamic Pressure Control™therapy. The V.A.C.Via™Starter Kits include one therapy unit, one carrying case,
one AC power cord, one 250cc canister and one Medium Spiral Granufoam Dressing. Dressing kits and
canisters for the V.A.C.Via™are also provided separately.
V.A.C.®THERAPY SAFETY INFORMATION
Disposable components of the V.A.C.®(Vacuum Assisted Closure®) Therapy System, including the foam
dressing (i.e., V.A.C.®GranuFoam™, V.A.C. GranuFoam Silver®, or V.A.C.®WhiteFoam Dressing), tubing and
drape are packaged sterile and are latex-free. V.A.C.®Therapy Unit canisters are packaged sterile or fluid
path sterile and are latex-free. All disposable components of the V.A.C.®Therapy System are for single use
only. To help ensure safe and effective use, the V.A.C.®GranuFoam™ Dressings are to be used only with
V.A.C.®Therapy Units.
The decision to use clean versus sterile/aseptic technique is dependent upon wound pathophysiology,
physician/clinician preference, and institutional protocol.
IMPORTANT: As with any prescription medical device, failure to consult a physician and carefully read
and follow all therapy unit and dressing instructions and safety information prior to each use may lead
to improper product performance and the potential for serious or fatal injury. Do not adjust therapy unit
settings or perform therapy application without directions from/or supervision by the clinical caregiver.
The V.A.C.Via™ Negative Pressure Wound Therapy System is intended to be operated by qualified clinical
caregivers in acute, extended or home-care settings. In-service and training programs for use of V.A.C.®
Therapy are available. Patients may monitor therapy unit information signals under the direction or
supervision of the clinical caregiver. Patients are not expected to apply or change V.A.C.Via™Dressings or
adjust therapy unit settings. For further information refer to Considerations for Transitioning V.A.C.®
Therapy into Homecare, page 4 of this guide.
INDICATIONS FOR USE
The V.A.C.Via™ Negative Pressure Wound Therapy System is an integrated wound management system
for use in acute, extended and home care settings. It is intended 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 exudates and
infectious material. It is indicated for patients with chronic, acute, traumatic, sub acute and dehisced
wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency) flaps and grafts.
CONTRAINDICATIONS
•Do not place foam dressings of the V.A.C.®Therapy System directly in contact with exposed blood vessels,
anastomotic sites, organs, or nerves.
NOTE: Refer to Warnings section for additional information concerning Bleeding.
•V.A.C.®Therapy is contraindicated for patients with:
•Malignancy in the wound
•Untreated osteomyelitis
NOTE: Refer to Warnings section for Osteomyelitis information.
•Non-enteric and unexplored fistulas
•Necrotic tissue with eschar present
NOTE: After debridement of necrotic tissue and complete removal of eschar, V.A.C.®Therapy may be
used.
WARNINGS
Bleeding: With or without using V.A.C.®Therapy, certain patients are at high risk of bleeding
complications.The following types of patients are at increased risk of bleeding, which, if uncontrolled, could
be potentially fatal.
•Patients who have weakened or friable blood vessels or organs in or around the wound as a result of,
but not limited to:
•Suturing of the blood vessel (native anastamoses or grafts)/organ
•Infection
•Trauma
1

•Radiation
•Patients without adequate wound hemostasis
•Patients who have been administered anticoagulants or platelet aggregation inhibitors
•Patients who do not have adequate tissue coverage over vascular structures.
If V.A.C.®Therapy is prescribed for patients who have an increased risk of bleeding complications, they
should be treated and monitored in a care setting deemed appropriate by the treating physician.
If active bleeding develops suddenly or in large amounts during V.A.C.®Therapy, or if frank (bright red)
blood is seen in the tubing or in the canister, immediately stop V.A.C.®Therapy, leave dressing in place,
take measures to stop the bleeding, and seek immediate medical assistance. The V.A.C.®Therapy Units and
dressings should not be used to prevent, minimize or stop vascular bleeding.
•Protect Vessels and Organs: All exposed or superficial vessels and organs in or around the wound
must be completely covered and protected prior to the administration of V.A.C.®Therapy.
Always ensure that V.A.C.®Dressings do not come in direct contact with vessels or organs. Use of a thick
layer of natural tissue should provide the most effective protection. If a thick layer of natural tissue is
not available or is not surgically possible, multiple layers of fine-meshed, non-adherent material, or bio-
engineered tissue may be considered as an alternative, if deemed necessary by the treating physician to
provide a complete protective barrier. If using non-adherent materials, ensure that they are secured in a
manner as to maintain their protective position throughout therapy.
Consideration should also be given to the negative pressure setting and therapy mode used when
initiating therapy.
Caution should be taken when treating large wounds that may contain hidden vessels, which may not
be readily apparent. The patient should be closely monitored for bleeding in a care setting deemed
appropriate by the treating physician.
•Infected Blood Vessels: Infection may erode blood vessels and weaken the vascular wall which may
increase susceptibility to vessel damage through abrasion or manipulation. Infected blood vessels are
at risk of complications, including bleeding, which, if uncontrolled, could be potentially fatal. Extreme
caution should be used when V.A.C.®Therapy is applied in close proximity to infected or potentially
infected blood vessels. (Refer to Protect Vessels and Organs section above.)
•Hemostasis, Anticoagulants, and Platelet Aggregation Inhibitors: Patients without adequate
wound hemostasis have an increased risk of bleeding, which, if uncontrolled, could be potentially fatal.
These patients should be treated and monitored in a care setting deemed appropriate by the treating
physician.
Caution should be used in treating patients on doses of anticoagulants or platelet aggregation
inhibitors thought to increase their risk for bleeding (relative to the type and complexity of the wound).
Consideration should be given to the negative pressure setting and therapy mode used when initiating
therapy.
•Hemostatic Agents Applied at the Wound Site: Non-sutured hemostatic agents (for example, bone
wax, absorbable gelatin sponge, or spray wound sealant) may, if disrupted, increase the risk of bleeding,
which, if uncontrolled, could be potentially fatal. Protect against dislodging such agents. Consideration
should be given to the negative pressure setting and therapy mode used when initiating therapy.
•Sharp Edges: Bone fragments or sharp edges could puncture protective barriers, vessels, or organs
causing injury. Any injury could cause bleeding, which, if uncontrolled, could be potentially fatal. Beware
of possible shifting in the relative position of tissues, vessels or organs within the wound that might
increase the possibility of contact with sharp edges. Sharp edges or bone fragments must be eliminated
from the wound area or covered to prevent them from puncturing blood vessels or organs before the
application of V.A.C.®Therapy. Where possible, completely smooth and cover any residual edges to
decrease the risk of serious or fatal injury, should shifting of structures occur. Use caution when removing
dressing components from the wound so that wound tissue is not damaged by unprotected sharp edges.
Infected Wounds: Infected wounds should be monitored closely and may require more frequent dressing
changes than non-infected wounds, dependent upon factors such as wound conditions and treatment
goals. Refer to dressing application instructions (page 6 of this IFU) for details regarding dressing change
frequency. As with any wound treatment, clinicians and patients/caregivers should frequently monitor
the patient’s wound, periwound tissue and exudate for signs of infection, worsening infection, or other
2

complications. Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased
warmth in the wound or periwound area, purulent discharge, or strong odor. Infection can be serious,
and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or
fatal injury. Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache,
dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory
and/or orthostatic hypotension, or erythroderma (a sunburn-like rash). If there are any signs of the onset of
systemic infection or advancing infection at the wound site, contact a physician immediately to determine if
V.A.C.®Therapy should be discontinued. For wound infections relating to blood vessels, please also refer to
the section titled Infected Blood Vessels.
Osteomyelitis: The V.A.C.®System should NOT be initiated on a wound with untreated osteomyelitis.
Consideration should be given to thorough debridement of all necrotic, non-viable tissue, including infected
bone (if necessary), and appropriate antibiotic therapy.
Protect Tendons, Ligaments and Nerves: Tendons, ligaments and nerves should be protected to avoid
direct contact with V.A.C.®Foam Dressings. These structures may be covered with natural tissue, meshed
non-adherent material, or bio-engineered tissue to help minimize risk of desiccation or injury.
Foam Placement: Always use V.A.C.®Dressings from sterile packages that have not been opened or
damaged. Do not place any foam dressing into blind/unexplored tunnels. The V.A.C.®WhiteFoam Dressing
may be more appropriate for use with explored tunnels. Do not force foam dressings into any area of the
wound, as this may damage tissue, alter the delivery of negative pressure, or hinder exudate and foam
removal. Always count the total number of pieces of foam used in the wound and document that number
on the foam quantity label and in the patient’s chart. Document the dressing change date on the foam
quantity label.
Foam Removal: V.A.C.®Foam Dressings are not bioabsorbable. Always count the total number of foam
pieces removed from the wound and ensure the same number of foam pieces was removed as was placed.
Foam left in the wound for greater than the recommended time period may foster ingrowth of tissue
into the foam, create difficulty in removing foam from the wound, or lead to infection or other adverse
events. If significant bleeding develops, immediately discontinue the use of the V.A.C.®Therapy System,
take measures to stop the bleeding, and do not remove the foam dressing until the treating physician or
surgeon is consulted. Do not resume the use of the V.A.C.®Therapy System until adequate hemostasis has
been achieved, and the patient is not at risk for continued bleeding.
Keep V.A.C.®Therapy On: Never leave a V.A.C.®Dressing in place without active V.A.C.®Therapy for
more than two hours. If therapy is off for more than two hours, remove the old dressing and irrigate the
wound. Either apply a new V.A.C.®Dressing from an unopened sterile package and restart V.A.C.®Therapy;
or apply an alternative dressing at the direction of the treating clinician.
Acrylic Adhesive: The V.A.C.®Advanced Drape has an acrylic adhesive coating, which may present a risk
of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives. If a patient has a
known allergy or hypersensitivity to such adhesives, do not use the V.A.C.®Therapy System. If any signs of
allergic reaction or hypersensitivity develop, such as redness, swelling, rash, urticaria, or significant pruritus,
discontinue use and consult a physician immediately. If bronchospasm or more serious signs of allergic
reaction appear, seek immediate medical assistance.
Defibrillation: Remove the V.A.C.®Dressing if defibrillation is required in the area of dressing placement.
Failure to remove the dressing may inhibit transmission of electrical energy and/or patient resuscitation.
Magnetic Resonance Imaging (MRI) -Therapy Unit: The V.A.C.®Therapy Unit is MR Unsafe. Do not
take the V.A.C.Via™Unit into the MR environment.
Magnetic Resonance Imaging (MRI) -V.A.C.®Dressings: V.A.C.®Dressings can typically remain on
the patient with minimal risk in an MR environment, assuming that use of the V.A.C.®Therapy System is not
interrupted for more than two hours (refer to Keep V.A.C.®Therapy On above).
Hyperbaric Oxygen Therapy (HBO): Do not take the V.A.C.®Therapy Unit into a hyperbaric oxygen
chamber. V.A.C.®Therapy Unit are not designed for this environment, and should be considered a fire
hazard. After disconnecting the V.A.C.®Therapy Unit, either (i) replace the V.A.C.®Dressing with another
HBO compatible material during the hyperbaric treatment, or (ii) cover the unclamped end of the V.A.C.®
Tubing with moist cotton gauze. For HBO therapy, the V.A.C.®Tubing must not be clamped. Never leave a
V.A.C.®Dressing in place without active V.A.C.®Therapy for more than two hours; please refer to the Keep
V.A.C.®Therapy On section above.
3

PRECAUTIONS
Standard Precautions: To reduce the risk of transmission of bloodborne pathogens, apply standard
precautions for infection control with all patients, per institutional protocol, regardless of their diagnosis or
presumed infection status. In addition to gloves, use gown and goggles if exposure to body fluids is likely.
Continuous versus Dynamic Pressure Control™(DPC) V.A.C.®Therapy: Continuous, rather
than Dynamic Pressure Control, V.A.C.®Therapy is recommended over unstable structures, such as an
unstable chest wall or non-intact fascia, in order to help minimize movement and stabilize the wound
bed. Continuous therapy is also generally recommended for patients at increased risk of bleeding, highly
exudating wounds, fresh flaps and grafts, and wounds with acute enteric fistulae.
Patient Size and Weight: The size and weight of the patient should be considered when prescribing
V.A.C.®Therapy. Infants, children, certain small adults and elderly patients should be closely monitored
for fluid loss and dehydration. Also, patients with highly exudating wounds or large wounds in relation
to the patient size and weight should be closely monitored, as they have a risk of excessive fluid loss and
dehydration. When monitoring fluid output, consider the volume of fluid in both the tubing and canister.
Spinal Cord Injury: In the event a patient experiences autonomic dysreflexia (sudden changes in blood
pressure or heart rate in response to stimulation of the sympathetic nervous system), discontinue V.A.C.®
Therapy to help minimize sensory stimulation and seek immediate medical assistance.
Bradycardia: To minimize the risk of bradycardia,V.A.C.®Therapy must not be placed in proximity to the
vagus nerve.
Enteric Fistulas: Wounds with enteric fistulas require special precautions to optimize V.A.C.®Therapy.
Refer to V.A.C.®Therapy Clinical Guidelines for more detail. V.A.C.®Therapy is not recommended if enteric
fistula effluent management or containment is the sole goal of therapy.
Protect Periwound Skin: Consider use of 3M™Cavilon™No Sting Barrier Film to protect periwound
skin. Do not allow foam to overlap onto intact skin. Protect fragile/friable periwound skin with additional
V.A.C.®Advanced Drape, hydrocolloid, or other transparent film.
•Multiple layers of the V.A.C.®Advanced Drape may decrease the moisture vapor transmission rate, which
may increase the risk of maceration.
•If any signs of irritation or sensitivity to the drape, foam, or tubing assembly appear, discontinue use
and consult a physician.
•To avoid trauma to the periwound skin, do not pull or stretch the drape over the foam dressing
during drape application.
•Extra caution should be used for patients with neuropathic etiologies or circulatory compromise.
Circumferential Dressing Application: Avoid use of circumferential dressings except in the presence of
anasarca or excessively weeping extremities, where a circumferential drape technique may be necessary to
establish and maintain a seal. Consider using multiple small pieces of V.A.C.®Advanced Drape rather than
one continuous piece to minimize the risk of decreased distal circulation. Extreme care should be taken
not to stretch or pull the drape when securing it, but let it attach loosely and stabilize the edges with an
elastic wrap, if necessary. When using circumferential drape applications, it is crucial to systematically and
recurrently palpate distal pulses, and assess distal circulatory status. If circulatory compromise is suspected,
discontinue therapy, remove dressing, and contact a physician.
CONSIDERATIONS FOR TRANSITIONING V.A.C.®THERAPY INTO HOMECARE
WARNING: Patients having an increased risk of bleeding complications should be treated and monitored
in a care setting deemed appropriate by the treating physician.
In addition to the contraindications, warnings and precautions for use of V.A.C.®Therapy, consider the
following before prescribing V.A.C.®Therapy for use in the home care setting.
The Patient’s Situation:
•Clinical condition (adequate hemostasis, and a low risk of active and/or large amounts of bleeding at
the wound site)
•Home environment (patient or family member/caregiver able to read and understand safety labeling,
able to respond to alarms, able to follow instructions for use)
4

The Patient’s Wound:
•Must be assessed for exposed vessels, anastomotic sites, organs, and nerves. Adequate protection must
be present without the need for a protective, non-adherent layer placed between the V.A.C.®Dressing
and the exposed structure for the sole purpose of protection of these structures (Refer to Protect
Vessels and Organs in the Warnings section).
Labeling:
•The prescribing physician and health care clinician should be familiar with and send the V.A.C.®Therapy
labeling materials that accompany the therapy unit and dressing cartons into the home.
•Additional homecare patient information is available from your KCI representative and on the KCI web
site www.kci1.com or vactherapy.com.The prescribing physician and/or healthcare clinician should
obtain these materials and carefully review them with the patient.
•KCI offers in-service and training programs for use of V.A.C.®Therapy. Contact your local KCI
representative. In the U.S., call 1-800-275-4524 for scheduling. In other countries, contact your local
KCI representative or KCI-medical.com or vactherapy.com.
For questions regarding the proper placement or usage of V.A.C.®Therapy, please refer to the V.A.C.®
Therapy Clinical Guidelines for more detailed instructions, or contact your local KCI clinical representative.
For additional and most current information, please see KCI’s web site at www.kci1.com, www.kci-
medical.com or vactherapy.com.
V.A.C.Via™THERAPY UNIT
The V.A.C.Via™Therapy Unit is a single use, disposable V.A.C.®Therapy Unit designed for moderate to low
severity wounds. The V.A.C.Via™Unit has a 7-day lifespan and a rechargeable battery. The therapy unit
features an interface panel which provides alarm and information signals and selectable therapy options.
This unit provides negative pressure at either 75 mmHg or 125 mmHg, and offers selection of Continuous
therapy or Dynamic Pressure Control™therapy.As a safety feature, all selector buttons need to be pressed
and held for three seconds for operation.The V.A.C.Via™Starter Kits include one therapy unit, one carrying
case, one AC power cord, one 250cc canister and one Medium Spiral Granufoam Dressing. Dressing kits
and canisters for the V.A.C.Via™are also provided separately.
CAUTION: Once therapy is on for one continuous hour, the 7-day lifespan begins (one light for each day
of therapy remaining) and continues even if unit is turned off.
WARNING: The V.A.C.Via™ Therapy Unit has no serviceable parts and should not be opened,
disassembled or otherwise modified by the user, and should be replaced as a unit. All assembly, operations,
adjustments, modifications, maintenance and repairs must be carried out by qualified personnel authorized
by KCI.
Electric Shock Hazard - Do not open any electrical cover on the therapy unit. There are no serviceable
parts. Refer to qualified KCI service personnel.
On/Off Button
Press and Hold Center
(For three Seconds)
to Turn On/Off
Battery Level Indicator
Power Connected Indicator
Therapy Life Indicators
Alarm Mute Button
Press and Hold Center
(For three Seconds)
to Mute
Blockage Alarm Leak Alarm
Selector Button
Press and Hold Center
(For three Seconds) for:
Continuous Therapy or
Dynamic Pressure
Control™
Selector Button
Press and Hold Center
(For three Seconds) for:
125 mmHg or
75 mmHg
5

V.A.C.Via™DRESSING APPLICATION INSTRUCTIONS
V.A.C.
®
Spiral GranuFoam™
Dressing - Medium
(Two per kit)
V.A.C.
®
Spiral GranuFoam™
Dressing - Small
(Two per kit) V.A.C.
®
Advanced Drape
Three with medium dressing
Two with small dressing
Skin Barrier Film
(3M™ Cavilon™ No Sting
Barrier Film)
Two with medium dressing
One with small dressing
See 3M™ Cavilon™
Instructions for Use
page 8
SensaT.R.A.C.
®
Pad
with Foam
Quantity Label V.A.C.
®
Ruler
Skin Barrier Film
(3M™ Cavilon™ No Sting
Barrier Film)
DRESSING CHANGES
Wounds being treated with a V.A.C.Via™Therapy System should be monitored on a regular basis. In a
monitored, non-infected wound, V.A.C.Via™Dressings should be changed every 48 to 72 hours, but no less
than three times per week, with frequency adjusted by the clinician as appropriate. Infected wounds must
be monitored often and very closely. For these wounds, dressings may need to be changed more often
than 48 to 72 hours; the dressing change intervals should be based on a continuing evaluation of wound
condition and the patient’s clinical presentation, rather than a fixed schedule.
For more information refer to the V.A.C.®Therapy Clinical Guidelines available at www.kci1.com, www.
kci-medical.com, vactherapy.com or contact your local KCI representative for a printed copy.
WOUND PREPARATION
WARNING: Review all V.A.C.®Safety Information (located in the front of these instructions) before
beginning wound preparation.
1. Remove and discard previous dressing per institution protocol. Thoroughly inspect wound to ensure all
pieces of dressing components have been removed.
WARNING: Refer to Foam Removal section under Warnings.
NOTE: If dressing adheres to wound, consider introducing sterile water or normal saline into the
dressing, waiting 15-30 minutes, then gently removing the dressing from the wound. Consider placing
a single layer, wide-meshed, non-adherent material prior to application of subsequent V.A.C.Via™
Dressings.
If patient complains of or exhibits signs of discomfort during the dressing change, consider use of a
non-adherent material prior to subsequent foam dressing placement, pre-medication, or introduction
of a topical anesthetic agent into the dressing as prescribed by physician 15-20 minutes prior to
dressing removal. Refer to V.A.C.®Therapy Clinical Guidelines for specific recommendations.
2. Debride all necrotic, non-viable tissue, including bone, eschar, or hardened slough, as prescribed by
physician.
3. Perform thorough wound and periwound area cleaning per physician order or institution protocol prior
to each dressing application.
4. Ensure adequate hemostasis has been achieved (refer to Warnings, Bleeding section, Hemostasis,
Anticoagulants and Platelet Aggregation Inhibitors).
5. Protect vessels and organs (refer to Warnings, Bleeding section, Protect Vessels and Organs).
6. Sharp edges or bone fragments must be eliminated from wound area or covered (refer to Warnings,
Bleeding section, Sharp Edges).
7. Clean and dry periwound tissue. Consider use of 3M™Cavilon™No Sting Barrier Film, provided with
V.A.C.Via™dressings, to protect and prepare periwound skin (Fig. 2). Refer to 3M™Cavilon™No Sting
Barrier Film product instructions for use, located on page eight of this guide. Do not allow foam to
overlap onto intact skin. Protect fragile/friable periwound skin with additional V.A.C.®Advanced Drape,
hydrocolloid, or other transparent film.
6

V.A.C.®SPIRAL GRANUFOAM™APPLICATION
Fig. 1 Fig. 2
Fig. 5
330331 Rev B
Fig. 6
Foam Quantity Label
Date Dressing Applied
Number of foam pieces
used in wound
Fig. 4
Fig. 3
Refer to V.A.C.®Therapy Clinical Guidelines for detailed instructions for treating different wound types
and for multiple wound applications.
1. Assess wound dimensions and pathology, including the presence of undermining or tunnels (Fig. 1).
Use V.A.C.®WhiteFoam Dressing with explored tunnels. Do not place any foam dressing into blind/
unexplored tunnels. V.A.C.®Dressings may be used for wounds with shallow undermining or tunnel
areas where the distal aspect is visible.
NOTE: If adjunct materials are utilized under the V.A.C.®Dressing, they must be meshed or
fenestrated to allow for effective delivery of negative pressure and exudate removal.
2. Carefully tear the V.A.C.®Spiral GranuFoam™ Dressing along the perforation to a size that will allow
the foam to be placed gently into the wound without overlaping intact skin (Fig. 3).
CAUTION: Do not cut or tear the foam over the wound, as fragments may fall into the wound (Fig.
4). Away from wound site, rub foam edges to remove any fragments or loose particles that may fall
into or be left in the wound.
3. Gently place foam into wound cavity, ensuring contact with all wound surfaces (Fig. 3). Do not force
the V.A.C.®Spiral GranuFoam™ Dressing into any areas of the wound.
NOTE: Ensure foam-to-foam contact between adjacent pieces of foam for even distribution of
negative pressure.
NOTE: Always note the total number of pieces of foam used in the wound and document on the
supplied foam quantity label (attached to the SensaT.R.A.C. ®pad tubing) (Fig. 6) and in the patient’s
chart.
NOTE: Superficial or retention sutures should be covered with a single layer of non-adherent
material placed between the sutures and the V.A.C.®Advanced Drape.
V.A.C.®ADVANCED DRAPE APPLICATION
Fig. 8 Fig. 9
Fig. 7
CAUTION: Patient’s skin condition should be carefully monitored (refer to the Precaution, Protect
Periwound Skin section (located in the front of these instructions).
1. Trim the V.A.C.®Advanced Drape to cover the V.A.C.®Spiral GranuFoam™Dressing and an additional
3-5 cm border of intact periwound tissue (Fig. 7). The V.A.C.®Advanced Drape may be cut into
multiple pieces for easier handling. Excess V.A.C.®Advanced Drape may be kept to seal difficult areas,
if needed.
2. Carefully remove layer 1 to expose adhesive (Fig. 8). The V.A.C.®Advanced Drape should be held by
the ruler/handling bars.
3. Place the adhesive side down over foam and apply V.A.C.®Advanced Drape to cover foam and intact
skin, ensuring V.A.C.®Advanced Drape covers at least a 3-5 cm border of intact periwound tissue.
Smooth any wrinkles in drape to prevent leaks.
4. Remove layer 2 and handling bars and pat V.A.C.®Advanced Drape to ensure an occlusive seal (Fig.
9).
7

8
SensaT.R.A.C.®PAD APPLICATION
1
222
1
1
1
1
1
1
2
Fig. 10 Fig. 11
Fig. 12 Fig. 13
2.5
cm
NOTE: Do not cut off the pad or insert the tubing into the foam dressing. This may occlude the tubing
and cause the V.A.C.®Therapy Unit to alarm.
1. Choose pad application site. Give particular consideration to fluid flow and tubing positioning to allow
for optimal flow, and avoid placement over bony prominences or within creases in the tissue.
2. Pinch V.A.C.®Advanced Drape and carefully cut an approximately 2.5 cm hole through the V.A.C.®
Advanced Drape (Fig. 10). The hole should be large enough to allow for removal of fluid and/or
exudate. It is not necessary to cut into the foam.
NOTE: Cut a hole rather than a slit, as a slit may self-seal during therapy.
3. Apply pad, which has a central disc and a surrounding outer adhesive skirt.
A. Remove both backing layers 1 and 2 to expose adhesive (Fig. 11).
B. Place pad opening in central disc directly over hole in V.A.C.®Advanced Drape (Fig. 12).
C.Apply gentle pressure on the central disc and outer skirt to ensure complete adhesion of the pad.
D. Pull back on blue tab to remove pad stabilization layer (Fig. 13).
E. If canister is on therapy unit connect dressing tubing to canister. If canister is not on therapy unit,
see V.A.C.Via™ Canister Installation section of these instructions.
NOTE: To prevent periwound maceration and skin irritation with wounds that are smaller than the
central disc of the pad, it is very important to frame the wound with drape to protect intact skin from
direct foam contact and that the central disc lay on top of a piece of foam at least 6.35 cm in
diameter. It may be necessary to augment the V.A.C.®Dressing with the larger end of the V.A.C.®
Spiral GranuFoam™ Dressing. For additional dressing application techniques, refer to the V.A.C.®
Therapy Clinical Guidelines available at www.kci1.com, www.kci-medical.com, vactherapy.com or
contact your local KCI representative for a printed copy.
3M™CAVILON™NO STING BARRIER FILM
(information provided by 3M™ Company)
PRODUCT DESCRIPTION:
3M™Cavilon™No Sting barrier Film (Barrier Film) is a polymeric solution which forms a uniform film when
applied to the skin. The product is dispersed in a unique non-cytotoxic, non-stinging solvent, which dries
rapidly. Barrier Film helps to protect intact or damaged skin from irritation caused by urine and/or fecal
incontinence, digestive juices, wound drainage, adhesives, and friction. The film is colorless, transparent,
and possesses good oxygen and moisture vapor permeability.
INTENDED USE:
3M™Cavilon™No Sting Barrier Film is a liquid intended for use as a film- forming product, that upon
application to intact or damaged skin forms a long lasting waterproof barrier, which acts as a protective
interface between the skin and bodily waste, fluids, adhesive products and friction. It is intended as a
primary barrier against irritation from body fluids.The product may be used on adults, children, and infants
over one month of age.
INGREDIENTS:
Hexamethyldisiloxane, isooctane, acrylate terpolymer, polyphenylmethylsiloxane.
CONTRAINDICATIONS:
Barrier Film is NOT to be used:
1. As the only covering in situations that require dressing protection from bacterial contamination/
penetration, e.g. intravenous therapy catheter sites and full or partial thickness wounds.
2. On infected areas of the skin.
WARNING: Barrier Film, in liquid form, is flammable; use in well ventilated area.Avoid using around
flames and sources of ignition. Keep out of reach of children.

9
PRECAUTIONS:
1. Should redness or other signs of irritation appear, or if redness or signs of irritation persist, consult a
physician.
2. Use of other barrier products, ointments, creams or lotions may significantly reduce its effectiveness.
DIRECTION FOR USE:
1. Skin should be clean and dry prior to application of Barrier Film.
2. Apply a uniform coating of film over entire area of concern.
3. If an area is missed, reapply to that area only after first application of Barrier Film (approximately 30
seconds).
4. If Barrier Film is applied to area with skin folds or other skin-to-skin contact, make sure that skin-
contact areas are separated to allow the film to thoroughly dry before returning to normal position.
5. When used under adhesive tapes, dressings, or devices:
(a) allow Barrier Film to thoroughly dry before covering with dressings or adhesive products.
(b) reapplication of Barrier Film is necessary each time dressing and /or adhesive products are
changed; the barrier film is removed by the adhesive.
6. When used as a protectant against body fluids, feces, or urine etc., and no adhesive products are
applied to skin:
(a) reapplication of Barrier Film is recommended every 24-72 hours, depending on frequency of
cleansing.
(b) in extreme cases (e.g. constant diarrheal stooling) with very frequent cleansing, more frequent
applications MAY be necessary (i.e. every 12-24 hours).
7. If desired, the film can be removed by using most medical adhesives removers as directed. Clean and
dry the involved area and reapply Barrier Film.
HOW SUPPLIED:
Individually packaged for single use only. Sterile unless package is damaged or open.
STORAGE INFORMATION:
For best results, this product should be stored at room temperature. For shelf life, refer to the expiration
date on each package.
V.A.C.Via™CANISTER INSTALLATION
The canister used with the V.A.C.Via™ Therapy Unit is a single-use, latex free, sterile, 250 cc/mL container
with graduated markings of approximately 50 cc/mL increments.
NOTE: If the canister is not fully engaged, the V.A.C.Via™ Therapy Unit will alarm.
NOTE: Never reuse a canister.
1. Remove the canister from the sterile package.
2. Hold therapy unit and canister, vertically or horizontally, one in each hand, and slide bottom of canister
into slot on bottom of therapy unit (Fig. 14 Step 1).
3. Close canister against therapy unit (Fig. 14 Step 2). The upper locking tab will click when canister is
secured (Fig. 14 Step 3).
Therapy Unit
Canister
Tubing Ports/Caps
Locking Tab
Step 1 Step 2 Step 3 Step 4
Fig. 14

10
4. Connect interface pad tubing to canister by aligning and plugging connector at end of tubing onto
tubing ports on side of canister (Fig. 15). Push together firmly. Ensure clamp on tube is open. Position
clamp away from patient.
Fig. 15
BEGINNING THERAPY
WARNING: Review all V.A.C.®Therapy System Safety Information, located in the front of these
instructions, before initiating therapy.
1. Ensure the the V.A.C.Via™Dressing has been applied as described in the Dressing Application section
of these instructions.
2. To begin therapy, press and hold center of the On/Off button for three seconds (Fig. 16). The
V.A.C.Via™ Therapy Unit, while in operation, is virtually silent. All seven Therapy Life Indicators will
illuminate with a green LED, indicating therapy is running.
NOTE: On initial start up the green LED above the 125 mmHg selector button (default setting) or
below the 75 mmHg selector button will flash until selected pressure is reached. When pressure is
reached, LED will stop flashing and remain solid.
Fig. 16
NOTE: To interrupt therapy or turn unit off, press and hold center of the On/Off button for three
seconds.
Once therapy is on for one continuous hour, the 7-day lifespan begins and continues
even if unit is turned off.
3. Select therapy pressure of 75 mmHg or 125 mmHg (press and hold center for three seconds).
•The green LED next to the button will indicate the selected pressure.
•If a pressure setting is not selected, therapy unit will default to 125 mmHg.
4. Select Continuous or Dynamic Pressure Control™(DPC) Therapy:
•Continuous therapy ( ) maintains the selected therapy at a constant pressure.
•Dynamic Pressure Control™therapy ( ) cycles the selected therapy as follows:
•75 mmHg - Pressure will cycle between 25 mmHg and 75 mmHg every 3 minutes.
•125 mmHg - Pressure will cycle between 25 mmHg and 125 mmHg every 3 minutes.
5. Assess dressing to ensure seal integrity. The dressing should be collapsed and should have a wrinkled
appearance. There should be no hissing sounds.
6. If there is any evidence of non-integrity, check interface pad and the V.A.C.Via™Dressing seals, tubing
connectors, and canister connection, and ensure clamp is open.
7. If there is any evidence of a leak, refer to the LEAKS section of these instructions.
8. Secure excess tubing to prevent interference with patient mobility (Fig 18).
NOTE: If the wound is over a bony prominence or in areas where weight bearing may exert

Tubing wrapped
around clips
11
additional pressure or stress to the underlying tissues, a pressure-relief surface or device should be
used to optimize patient offloading.
9. If desired, place the therapy unit into the carrying case (Fig. 17). Ensure display is visible through the
opening in the carrying case.
Fig. 17
10. The carrying case comes with both an adjustable strap and belt clip for carrying (Fig. 18). The belt clip
and additional clips on each side and at the bottom of the carrying case provide a place where excess
tubing may be wrapped and stored to help prevent/minimize tripping (Fig. 18).
CAUTION: Do not wear strap around neck.
Fig. 18
DURATION OF THERAPY
Therapy Life Indicators
The therapy life indicators provide a visual indication of the seven day therapy life cycle and the therapy
life remaining (Fig. 19).When therapy begins all seven green LEDs are illuminated. During therapy,
after each 24-hour period an indicator will turn off. When eight hours of therapy time remains, the last
indicator will illuminate with both a green and yellow LED simultaneously (NOTE: in Fig. 19 below, black
represents green indicators and grey represents yellow indicators). When therapy time is about to expire,
the last indicator will illuminate with a yellow LED and an audible alarm will sound for approximately two
minutes, then the therapy unit will shut off.
At the end of therapy, the therapy unit must be replaced with a new therapy unit or alternative therapy
must be used. Patients should be instructed to contact the treating physician or caregiver if therapy unit
turns off and cannot be restarted before therapy is scheduled to end.
Begin Therapy 4 Days Left 2 Days Left 1 Day Left 8 Hours Left Therapy Ended
Fig. 19
NOTE: Once therapy is on for one continuous hour, the 7-day lifespan begins and
continues even if unit is turned off.

12
WARNING: Never leave a V.A.C.®Dressing in place without active V.A.C.®Therapy for more than two
hours. If therapy is off for more than two hours, remove the old dressing and irrigate the wound. Either
apply a new V.A.C.®Dressing from an unopened sterile package and restart V.A.C.®Therapy; or apply an
alternative dressing at the direction of the treating physician or caregiver.
DRESSING REMOVAL
NOTE: If dressing is lifted to observe wound, do not re-adhere the same dressing, a new dressing must
be applied.
1. Turn therapy unit off by pressing and holding the On / Off button for three seconds.
2. Gently stretch the drape horizontally to release the adhesive from the skin.
3. Do not peel vertically. Gently remove the drape from the wound.
4. Clean any residual adhesive with alcohol swab.
If a new dressing is to be applied:
1. Ensure that area is clean, using an alcohol swab or antiseptic wipe.
2. Allow skin to completely dry before applying.
3. Follow Dressing Application instructions, page 6.
CANISTER REMOVAL AND REPLACEMENT
1. Turn therapy off.
2. Slide dressing tubing clamp close to where tubing plugs into canister. Close clamp.
3. Unplug tubing from canister tubing ports.
4. Remove therapy unit from carrying case, if in use.
5. Depress tab on canister to remove used canister from therapy unit (Fig. 14).
6. Install new canister (see Canister Installation section in these instructions).
7. Return therapy unit to carrying case if desired.
8. Reattach dressing tubing to canister tubing ports.
9. Release tubing clamp.
10. Turn therapy on.
NOTE: Dispose of used canister according to institution and local environmental regulations.
LEAKS
When the therapy unit detects a significant leak, a visual and audible leak alarm will activate (See also
the Alarms section of these instructions). When 125 mmHg is selected, the leak alarm will activate at
pressures of 75 mmHg or less.When 75 mmHg is selected, the leak alarm will activate at pressures of
50 mmHg or less.
1. During a leak condition, a solid yellow LED above the leak symbol will turn on.The system will sound
two beeps repeating every 15 seconds.The therapy unit will continue the alarm until condition is
corrected.
WARNING: Never leave a V.A.C.®Dressing in place without active V.A.C.®Therapy for more than
two hours. If therapy is off for more than two hours, remove the old dressing. Either apply a new
V.A.C.®Dressing from an unopened sterile package and restart V.A.C.®Therapy; or apply an alternative
dressing at the direction of the treating physician or caregiver.
2. When leak condition has been corrected, audible alarms will stop, and visual alarms will turn off.
NOTE: The green LED next to the therapy pressure selector button, 75 mmHg or 125 mmHg, will
remain on while the therapy system cycles through the steps above.
NOTE: When 75 mmHg is selected, the operating range is 50 mmHg to 75 mmHg.When 125 mmHg
is selected, the operating range is 75 mmHg to 125 mmHg.
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