Clinicians Instructions for Use
36 Pages
Preview
Page 1
Prevena™ Incision Management System
Instructions for Use for Clinicians Featuring
Peel & Place™ Dressing and
Customizable™ Dressing
Table of Contents Important Information for Users... 5 Indication for Use... 5 Optimum Use Conditions... 5 Contraindication... 5 Warnings... 6 Precautions... 7 Prevena™ Incision Management System (IMS) Site Preparation... 8 Drain Tubes and Pain Management Control Devices...8
Prevena™ Incision Management System Dressings... 8 Prevena™ Peel & Place™ Dressing Application Instructions... 9 Peel & Place™ Dressing Components...9 Prevena™ Peel & Place™ Dressing Application... 10
Prevena™ Customizable™ Dressing Application Instructions...11 Customizable™ Dressing Components... 11 Prevena™ Customizable™ Dressing Applications... 12 Drape Application... 18 Interface Pad Application... 20
Prevena™ Canister Install and Connect...21 Beginning Prevena™ Therapy...21 Duration of Therapy... 22 Dressing Removal... 22 New Dressing Application... 22
Indicators and Alerts...23 Leaks...24 VisiCheck™ Feature... 24
Correcting a Leak Condition...24 Prevena™ Peel & Place™ Dressing... 24 Prevena™ Customizable™ Dressing ... 25 Check Canister and Tubing Connection... 25 Indications That a Leak Condition Has Been Corrected... 25
Prevena™ Dressing Pressure Indicator...26 Battery Replacement...26 Instructions For Patient...27 Daily Use... 27 Sleeping... 27 Showering and Bathing... 27 Strenuous Activity... 27 Cleaning... 28
Device Disposal...28 Using the Prevena™ Dressing with KCI V.A.C.® Therapy Units...28 Alarm Resolutions... 28
Specifications ...29 Electromagnetic Compatibility...29 Symbols Used...33 Customer Contact Information...33
INSTRUCTIONS FOR USE PREVENA™ INCISION MANAGEMENT SYSTEM KCI customer contact information is located in the back of this guide.
Important Information for Users As with any prescription medical device, failure to carefully read and follow all instructions and safety information prior to use may lead to improper product performance. All of the Prevena™ Incision Management System (IMS) components are disposable and are for single use only. Re-use of disposable components may result in wound contamination, infection and / or failure of the wound to heal. CAUTION: The Prevena™ IMS should be applied and removed only by qualified physicians, nurses or caregivers.
Indication for Use The Prevena™ Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.
Optimum Use Conditions For maximum benefit the Prevena™ IMS should be applied immediately post surgery to clean surgically closed wounds. It is to be continuously applied for a minimum of two days up to a maximum of seven days. It can transition home with the patient; however, all Prevena™ Dressing changes should be performed under direct medical supervision. The Prevena™ IMS will not be effective in addressing complications associated with the following: ••
ischemia to the incision or incision area
••
untreated or inadequately treated infection
••
inadequate hemostasis of the incision
••
cellulitis of the incision area
The Prevena™ IMS should not be used to treat open or dehisced surgical wounds or on patients who have excessive amounts of exudate from the incision area which may exceed the Prevena™ 45 mL Canister. The V.A.C.® Therapy System should be considered for treatment of these wounds. The Prevena™ IMS should be used with caution in the following patients: ••
patients with fragile skin surrounding the incision as they may experience skin or tissue damage upon removal of the Prevena™ Dressing
••
patients who are at an increased risk of bleeding from the incision associated with the use of anticoagulants and / or platelet aggregation inhibitors
Contraindication ••
sensitivity to silver
5
Warnings Bleeding: Before applying the Prevena™ IMS to patients who are at risk of bleeding complications due to the operative procedure or concomitant therapies and / or co-morbidities, ensure that hemostasis has been achieved and all tissue planes have been approximated. If active bleeding develops suddenly or in large amounts during therapy, or if frank blood is seen in the tubing or in the canister, the patient should leave the Prevena™ Dressing in place, turn off the Prevena™ 125 Therapy Unit and seek immediate emergency medical assistance. Infected Wounds: As with any wound treatment, clinicians and patients / caregivers should frequently monitor the patient’s wound, periwound tissue and exudate for signs of infection or other 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). Silver in the interface layer of the Prevena™ Dressing is not intended to treat infection, but to reduce bacterial colonization in the fabric. If infection develops, Prevena™ Therapy should be discontinued until the infection is treated. Allergic Response: The Prevena™ Dressing has an acrylic adhesive coating and a skin interface layer with silver, which may present a risk of an adverse reaction in patients who are allergic or hypersensitive to acrylic adhesives or silver. If a patient has a known allergy or hypersensitivity to these materials, do not use the Prevena™ IMS. If any signs of allergic reaction, irritation or hypersensitivity develop, such as redness, swelling, rash, urticaria or significant pruritus, patient should consult a physician immediately. If bronchospasm or more serious signs of allergic reaction appear, the patient should turn off the therapy unit and seek immediate emergency medical assistance. Defibrillation: Remove the Prevena™ 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): The Prevena™ 125 Therapy Unit is MR unsafe. Do not take the Prevena™ 125 Therapy Unit into the MR environment. The Prevena™ Dressings can typically remain on the patient with minimal risk in an MR environment. Interruption of Prevena™ Therapy during MRI may reduce the effectiveness of Prevena™ Therapy. Diagnostic Imaging: The Prevena™ Dressing contains metallic silver that may impair visualization with certain imaging modalities. Hyperbaric Oxygen Therapy (HBO): Do not take the Prevena™ 125 Therapy Unit or Prevena™ Dressings into a hyperbaric oxygen chamber. They are not designed for this environment and should be considered a fire hazard. If Prevena™ Therapy is reinitiated after HBO treatment, do not readhere the same dressing; a new dressing must be applied. Canister Full: If at any time while using the Prevena™ IMS the canister becomes full of fluid other than blood, indicated by a Maximum Capacity Alert or visual inspection, the patient should turn off the therapy unit and contact the treating physician. Standard Operation: Do not use accessories or materials not provided with the Prevena™ IMS. For a list of acceptable therapy units with which Prevena™ Dressings may be used, see the Using the Prevena™ Dressing with KCI V.A.C.® Therapy Units section on page 28.
6
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. Circumferential Dressing Application: Avoid applying the Prevena™ Dressing circumferentially. In cases where the clinician determines that the benefits of applying the Prevena™ Dressing circumferentially outweigh the risk of circulatory compromise, extreme care should be taken not to stretch or pull the dressing when securing it. Attach the dressing loosely and stabilize edges with an elastic wrap if necessary. It is crucial to systematically and recurrently palpate distal pulses and assess distal circulatory status. If circulatory compromise is suspected, discontinue therapy and remove dressing. Electrodes or Conductive Gel: Do not allow the Prevena™ Dressing to come in contact with EKG or other electrodes or conductive gels during electronic monitoring or when taking electronic measurements. Dressing Components: The Prevena™ Dressing contains ionic silver (0.019%). Application of products containing silver may cause temporary tissue discoloration. ••
Always use Prevena™ Dressings and canisters from sterile packages that have not been opened or damaged.
••
All components of the Prevena™ IMS are for single use only. Do not re-use any component of this system.
••
To avoid trauma to the skin, do not pull or stretch the adhesive border of the dressing during application.
7
Prevena™ Incision Management System (IMS) Site Preparation 1. Prior to surgery, shave or clip the surgical area where the dressing will be applied to improve dressing adhesion and seal integrity. 2. Gather all items needed for application: ••
sterile wound cleaning solution, e.g. water, saline or alcohol
••
sterile gauze or other material to clean application site
••
Prevena™ IMS (Check expiration date on box)
3. After surgery, cleanse the application site with sterile gauze and sterile wound cleaning solution using a circular motion beginning at the center of the surgical area and extending outward to ensure that the site is free of foreign material. 4. Pat the application site dry with sterile gauze. To ensure proper adhesion, the application site must be completely dry before dressing is applied.
Drain Tubes and Pain Management Control Devices The Prevena™ IMS can be used with both drain tubes and pain devices, provided the dressing is not placed over tubing where it exits the skin. Surgical drains must be routed under the skin beyond the boundary of the dressing and function independently of the Prevena™ IMS. NOTE: While the concomitant use of surgical drains is allowable with the Prevena™ IMS, the system must not be used as an outlet or reservoir for the drain.
Prevena™ Incision Management System Dressings The Prevena™ IMS features Peel & Place™ Dressing and Customizable™ Dressing. These dressings contain a skin interface layer that includes 0.019% ionic silver. In vitro log reduction tests, conducted without application of negative pressure, exposed samples of the skin interface layer to a six log challenge of each of the microorganisms listed below. Following inoculation, samples were tested for microbial counts immediately (day 0) and after incubation at 90˚F (32˚C) in diluted nutrient broth for 1, 3, 5 and 7 days. The log reductions from the day 0 values are provided in the table below.
Challenge Organism
Mean Log Reduction from Day 0 Day 1
8
Day 3
Day 5
Day 7
Escherichia coli (ATCC 8739)
2.2
4.0
3.9
4.5
Pseudomonas aeruginosa (ATCC 09027)
2.0
3.9
3.5
3.7
Staphylococcus aureus (ATCC 6538)
1.6
3.6
3.6
3.5
Klebsiella pneumonia (ATCC 4352)
1.4
1.8
2.7
3.5
Candida albicans (ATCC 10231)
2.5
3.1
3.2
3.2
Aspergillus niger (ATCC 16404)
2.2
4.1
4.0
3.6
Prevena™ Peel & Place™ Dressing Application Instructions Peel & Place™ Dressing Components The sterile Peel & Place™ Dressing system contains the following single use, disposable components. Prevena™ Dressing with Pressure Indicator - a specially designed dressing for application to the surgical area
Prevena™ Patch Strips™ - used to help seal leaks around dressing
Prevena™ 45 mL Canister - a sterile reservoir for collection of wound fluids
Prevena™ 125 Therapy Unit - delivers negative pressure to the surgical area. The unit is battery powered. The non-sterile Prevena™ Carrying Case is provided to facilitate patient mobility.
V.A.C.® Connector - used to connect the Prevena™ Dressing to a KCI V.A.C.® Therapy Unit
9
Prevena™ Peel & Place™ Dressing Application CAUTION: If the dressing covers the umbilicus, the umbilicus must first be fully filled with an anti-microbial petroleum gauze prior to dressing application. 1. Open the sterile dressing package and remove dressing and patch strips using aseptic technique. Do not use if package has been torn or the sterile seal has been compromised. 2. Gently peel back the center strip on the back of the dressing exposing the pull tabs and adhesive.
3. Center and apply the dressing over the closed wound or incision ensuring that the adhesive will not contact or cover the surgical closure. Orient the dressing on the patient to eliminate sharp bends or kinks in the tubing. 4. Remove the remaining bottom adhesive covers by grasping the bottom tabs and gently pulling.
5. Firmly press around the dressing to ensure a good seal where the adhesive contacts the skin.
6. Remove top stabilization layers.
10
Prevena™ Customizable™ Dressing Application Instructions Customizable™ Dressing Components The sterile Customizable™ Dressing system can be used for linear / non-linear incision applications and contains the following single use, disposable components. Prevena™ Customizable™ Dressing (folded) - a specially designed dressing for application to the surgical area
Sealing Strips - used to create a continuous adhesive seal around the Prevena™ Customizable™ Dressing
KCI Drapes - used to cover dressing and provide a seal for negative pressure
Ruler - used to measure incision before cutting. The removeable label may be used as needed to record date of dressing application or removal. The oval cutout on the ruler is to be used as a template for cutting a hole in the drape for the interface pad.
Interface Pad - used to connect the Customizable™ Dressing to therapy unit
Prevena™ 45 mL Canister - a sterile reservoir used to collect wound fluids
Prevena™ 125 Therapy Unit - delivers negative pressure to the surgical area. The unit is battery powered. The non-sterile Prevena™ Carrying Case is provided to facilitate patient mobility.
V.A.C.® Connector - used to connect the Prevena™ Dressing to a KCI V.A.C.® Therapy Unit 11
Prevena™ Customizable™ Dressing Applications The Prevena Customizable™ Dressing can be used for the following wound types: ••
linear incisions
••
non-linear incisions
••
intersecting incisions
The following figures show completed dressing applications using the Customizable™ Dressing, KCI Drape and interface pad.
Linear Incision Dressing Application
Non-linear Incision Dressing Application
Intersecting Incision Dressing Application
Dressing Application for Linear Incisions CAUTION: If the dressing covers the umbilicus, the umbilicus must first be fully filled with an anti-microbial petroleum gauze prior to dressing application. 1. Open the sterile dressing package, remove and unfold foam dressing using aseptic technique. Do not use if package has been torn or the sterile seal has been compromised. 2. Use the enclosed ruler to measure incision before cutting. 3. Cut foam dressing to the length necessary to cover the incision. CAUTION: Do not cut the foam over the wound, as fragments may fall into the wound. Away from wound site, rub foam edges to remove any fragments or loose particles that may fall into or be left in the wound upon dressing removal.
12
4. Remove bottom release liner 1 on the foam dressing to expose adhesive seal and white fabric located on the bottom of the foam dressing. The white fabric covers the incision.
5. Add sealing strips to the ends of the foam dressing. NOTE: Use the Prevena™ Customizable™ Dressing to size the sealing strip as needed to fit the width of the dressing, approximately 3 in (8 cm). ••
Liner 1 must be removed from the dressing before applying sealing strips.
••
For sealing strips that have white liners: remove either top or bottom liner from the sealing strip. Sealing strips are tacky on both sides.
••
For sealing strips that have liners marked 1 and 2: remove liner 1 from the sealing strip.
Place sealing strip on end of foam dressing (creating a continuous seal). The strip should be placed half on dressing and half off dressing and overlap the adhesive seal on each side of the dressing. This ensures a seal all around the edge of the dressing. •• Remove either the remaining white liner or liner 2 from the sealing strip. Repeat strip application on other end of foam dressing. ••
6. With sealing strips applied, position the foam dressing until the adhesive seal and white fabric are facing down.
7. Center the foam dressing over the incision / surgical closure. Ensure the adhesive seal and white fabric are facing down.
13
8. Press down around the length of the adhesive seal to ensure adhesion to the skin.
9. Peel off release liner 2 from the top of the adhesive seals.
10. Once the foam dressing has been applied to the incision, continue with the drape application (see the Drape Application section on page 18).
14
Dressing Application for Non-linear Incisions CAUTION: If the dressing covers the umbilicus, the umbilicus must first be fully filled with an anti-microbial petroleum gauze prior to dressing application. 1. Open the sterile dressing package, remove and unfold foam dressing using aseptic technique. Do not use if package has been torn or the sterile seal has been compromised. 2. Use enclosed ruler to measure incision before cutting. 3. Cut foam dressing to the length and shape necessary to cover the incision. CAUTION: Do not cut the foam over the wound, as fragments may fall into the wound. Away from wound site, rub foam edges to remove any fragments or loose particles that may fall into or be left in the wound upon dressing removal. 4. Make straight cuts at the desired angles to ensure the foam dressing pieces and seals make a flush / even connection with no gaps. CAUTION: Gaps at foam junctions may potentially cause erythema due to pinching of the skin when negative pressure is applied.
5. Use a sealing strip to bridge where the foam dressing pieces meet. Sealing strip should have equal overlap on both foam dressing pieces. NOTE: Use the Prevena™ Customizable™ Dressing to size the sealing strip as needed to fit the width of the dressing, approximately 3 in (8 cm). ••
Liner 1 must be removed from the dressing before applying sealing strips.
15
••
Place sealing strip on end of foam dressing (creating a continuous seal). The strip should be placed half on dressing and half off dressing and overlap the adhesive seal on each side of the dressing. This ensures a seal all around the edge of the dressing.
NOTE: Having exposed adhesive material around all edges of the dressing provides a greater seal when the drape is applied. ••
Remove the remaining liner from the sealing strip. Repeat strip application on other end of foam dressing.
6. With sealing strips applied, position the foam dressing until the adhesive seal and white fabric are facing down. 7. Place the foam dressing over the incision / surgical closure. Ensure the adhesive seal and white fabric are facing down. 8. After foam dressing placement is completed, ensure all liners are removed before continuing with the drape application (see the Drape Application section on page 18).
16
Dressing Application for Intersecting Incisions CAUTION: If the dressing covers the umbilicus, the umbilicus must first be fully filled with an anti-microbial petroleum gauze prior to dressing application. 1. Open the sterile dressing package, remove and unfold foam dressing using aseptic technique. Do not use if package has been torn or the sterile seal has been compromised. 2. Use enclosed ruler to measure incision before cutting. 3. Cut dressing as needed to fit incision. Ensure the foam dressings and seals meet with no gaps. CAUTION: Do not cut the foam over the wound, as fragments may fall into the wound. Away from wound site, rub foam edges to remove any fragments or loose particles that may fall into or be left in the wound upon dressing removal. CAUTION: Gaps at foam junctions may potentially cause erythema due to pinching of the skin when negative pressure is applied.
CAUTION: Do not overlap foam dressing pieces on top of each other.
4. Use sealing strips at the ends of the foam dressing to create a continuous seal. Sealing strip should have equal overlap on both foam dressing pieces. NOTE: Use the Prevena™ Customizable™ Dressing to size the sealing strip as needed to fit the width of the dressing, approximately 3 in (8 cm). ••
Liner 1 must be removed from the dressing before applying sealing strips.
5. With sealing strips applied, position the foam dressing until the adhesive seal and white fabric are facing down. NOTE: It is acceptable if sealing strips cover the incision line. 6. Place the foam dressing over the incision / surgical closure. Ensure the adhesive seal and white fabric are facing down. 7. After foam dressing placement is completed, ensure all liners are removed before continuing with the drape application (see the Drape Application section on page 18).
17
Drape Application CAUTION: Do not cover the umbilicus with drape. Before or after placement, ensure a small hole is cut in the drape in relation to the umbilicus. Multiple pieces of drape may be needed when using Customizable™ Dressings depending on incision size. Drapes should always overlap each other by at least 1.2 in (3 cm). All dressing liners must be removed before any drape is used.
1. Trim KCI Drape as necessary. Ensure a minimum overlap of 1.2 in (3 cm) when using multiple pieces of KCI Drape. There is no drape under the blue handling bars.
2. Carefully remove the middle section of layer 1 from KCI Drape to expose adhesive. Leave the two end sections of layer 1 intact to maintain drape stability during application. The KCI Drape should be held by the blue handling bars.
3. With adhesive side down, apply KCI Drape over foam and onto intact skin. Ensure KCI Drape covers a minimum of 1.2 in (3 cm) of intact periwound tissue.
4. Lift the drape at both ends and remove the two remaining end sections of layer 1. Smooth out any wrinkles in the KCI Drape. CAUTION: Do not press blue handling bars down onto the sealing material.
5. Carefully remove striped layer 2 from KCI Drape.
6. Remove the two blue handling bars.
18
7. Add additional drape as needed to cover foam dressings in various configurations, as shown. Smooth KCI Drape to remove creases and seal joints ensuring an occlusive seal. •• All liners must be removed before additional drape is used. ••
••
Press drape down around the length of the adhesive seal to ensure adhesion to the skin.
••
Press down to seal all drapes.
••
Minimize any creases / wrinkles in drape. Excess KCI Drape can be used to seal leaks.
3
2
1
••
19
Interface Pad Application CAUTION: Do not place the interface pad directly over the umbilicus.
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
1. Use the oval cutout on the enclosed ruler as a template for hole size when cutting a hole in the drape for the interface pad. The removeable label may be used as needed to record date of dressing application or removal.
17
Hole Template
0
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
2. Near center of foam dressing, carefully cut a hole in KCI Drape using a scalpel or scissors. It is not necessary to cut into the foam but if a small amount of foam is removed it will not inhibit performance.
17
3. Remove the cut section of drape.
1
4. Remove both backing layers 1 and 2 from pad to expose adhesive.
1 1 1 1 1 2
2
2
2
1
5. Place the pad opening in the central disc directly over hole in KCI Drape. Apply gentle pressure on the central disc and outer skirt to ensure complete adhesion of the pad.
6. Pull back on blue tab to remove pad stabilization layer. Interface pad application is complete.
20
Prevena™ Canister Install and Connect 1. Remove the Prevena™ 45 mL Canister from the sterile package. Do not use if package has been torn or the sterile seal has been compromised. Side Tabs
2. Insert the canister into the Prevena™ 125 Therapy Unit and slide inward until canister clicks. Canister is fully inserted when the side tabs are flush with the body of the therapy unit. 3. Connect the dressing tubing to the canister tubing by twisting the connectors until they lock. Peel & Place™ Dressing view is provided as representative example. 4. Begin therapy.
Beginning Prevena™ Therapy 1. Press and hold the On / Off button for two seconds; an audible beep will confirm that therapy is on. A green light on the front of the unit indicates that therapy is on.
Green Light
On / Off Button
NOTE: Pressing the On / Off button begins the 192 hour (eight day expected service life) life cycle of the therapy unit. Turning the therapy unit off stops the life cycle counter. Turning the therapy unit on for purposes other than delivering therapy reduces the life cycle of the therapy unit. It is not recommended to press the On / Off button until therapy is ready to begin. NOTE: To turn therapy unit off, press and hold the On / Off button for five seconds. 2. With therapy on, assess dressing to ensure integrity of seal. The dressing should have a wrinkled appearance and the foam bolster should be compressed. •• The pressure indicator on the dressing should be in the collapsed position. •• If there is any evidence of a leak, refer to the Leaks section on page 24. ••
3. Place the therapy unit into the Prevena™ Carrying Case. Make sure the display is visible through the opening in the carrying case when the front flap is lifted.
21