Avance User Guide Rev 00

INDEX AvanceTM Negative Pressure Wound Therapy System

4

Intended Use

4

Wound Dressing Guidelines

5

AvanceTM Pump

10

Initial Pump Delivery and Set-up

11

AvanceTM Pump Disposables

12

Preparation for Use

13

AvanceTM Pump User Modes

14

Administrative Mode

14

Connect Avance Drain to AvanceTM Canister and Tubing

16

Change Settings

17

Frequency of Change

19

Alarms

21

Cleaning

23

Disposal

23

Technical specifications

24

Signs and Symbols

25

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AvanceTM Negative Pressure Wound Therapy System With Avance you have acquired a system for use in Negative Pressure Wound Therapy (NPWT) including the Avance Pump which provides the vacuum intensity (-60 to -200 mmHg) and vacuum mode (constant or intermittent), with an electronic measuring system with optical and acoustic status displays. The small sized pump is light weighted and quiet during operation and has alarm functions for patient safety.

Intended Use The Avance NPWT system is intended to help promote wound healing, including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressure. Avance NPWT system is designed to be used for a wide range of wounds which are suitable for NPWT. Avance Pump is portable and can be operated independent of the mains thanks to a rechargeable battery. Acoustic and optical signals are triggered for variances from the set values as well as for faults. Avance NPWT system is intended for use on people in all stations of the hospital and in the home area and may only be used by trained personnel. Consideration should be taken to patient hearing function and visual acuity prior treatment in home care.

Indications for use The Avance NPWT system is appropriate for use on the following wounds: • Traumatic • Surgical (sternal/abdominal/extremity) • Chronic wounds including pressure ulcers, diabetic foot ulcers and venous leg ulcers • Partial-thickness burns • Dehisced wounds • Flaps and grafts

Contraindications Contraindications for treatment with the Avance NPWT system: • Direct positioning of NPWT over exposed organs, large veins & arteries, tendors or nerves • Malignant wounds • Untreated osteomyelitis or malnutrition • Non-enteric and unexplored fistula • Undebrided wounds with necrotic tissue with eschar present

For more information, please see the complete Instructions for Use for Avance Negative Pressure Wound Therapy.

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Wound Dressing Guidelines Application instructions Use clean/aseptic or sterile techniques for application according to local protocol. Sterility is maintained unless inner package is damaged or opened prior to use. Performance of product may deteriorate and cross contamination may occur if reused. Do not use oxidising agents, such as hydrochlorite solutions or hydrogen peroxide before use of Avance foam dressing.

Wound bed preparation 1.

Cleanse the wound and the periwound skin as per local protocol or clinician’s instructions.

2.

Debride all necrotic, non-viable tissue, including eschar, fibrin or hardened slough, as prescribed by clinician.

3.

Sharp edges or bone fragments must be eliminated from wound area or covered with a non-adherent wound contact layer (e.g. Mepitel).

4.

Assess wound dimensions and pathology, including the presence of undermining or tunnels as a basis for deciding if a wound contact layer should be used and which type of wound filler material should be used.

5.

If Mepitel is used to protect tissue, cut it to suitable size and shape and place into the wound cavity. If several layers of Mepitel are used, make sure that the holes are not blocked due to the overlapping layers since blockage will hinder delivery of negative pressure to the wound. Warning: If Mepitel is used, always document it in the patient’s notes to avoid risk of Mepitel being left in the wound when the dressing is changed.

6.

Apply skin protector/skin sealant on periwound skin if required.

7.

Choose the appropriate wound filler (foam or gauze) according to clinician’s instructions. Following wound assessment, see the instructions below regarding application for either foam or gauze.

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Wound filler and drain application 7.1 7.1.1

Avance Foam If selecting foam filler, cut the foam into a size and shape corresponding with the dimensions of the wound cavity. If necessary the foam can be cut in half to make it thinner or stacked to double thickness depending on wound depth.

Warning: Do not overlap the foam onto intact skin. Warning: Do not place foam into unexplored or blind tunnels or non-enteric fistulas.

7.1.2

Remove any fragments from the foam edges to ensure that loose particles will not fall into the wound or be left in the wound after removal.

Warning: Do not cut the foam over the wound site, as fragments may fall into the wound.

7.1.3

Measure the length of the wound and cut the drain approximately 1-2 cm shorter than the measured distance. There are two alternative ways to place the drain with the foam, see alternative A and B below.

Alternative A – Drain on top of foam 1.

Gently place the foam into wound cavity, and ensure contact with all wound surfaces. Place the flat drain on top of the foam. Ensure that there is no contact between the drain and the wound tissue to minimize the risk of imprints.

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Alternative B – Drain within the foam 1.

This way of positioning the drain will minimize the risk of excess pressure to the wound edges. Cut or use a scalpel to create an incision in the foam for placement of the drain. Do not extend the incision to the edges of the foam.

2.

Cut the drain to fit into the incision.

3.

Place the flat drain in the incision created in the foam. Gently place the foam into the wound cavity, and ensure contact with all wound surfaces.

4.

Ensure that the wound cavity is sufficiently filled with foam without overpacking.

Warning: If more than one piece of foam is used, always count the total number of pieces used in the dressing and document in the patient’s notes. Ensure foam-to-foam contact between all pieces of foam for even distribution of negative pressure. Warning: Do not overpack foam into any area of the wound, as this may maintain the wound cavity, damage tissue, hinder exudates removal or hinder delivery of negative pressure.

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7.2 7.2.1

AMD gauze If selecting gauze filler, measure the length of the wound and cut the drain approximately 1-2 cm shorter than the measured distance.

Warning: Do not place gauze into unexplored or blind tunnels or non-enteric fistulas.

7.2.2

Saturate a single layer of gauze with normal saline or sterile water. Wrap the moistened gauze around the drain.

7.2.3

Gently place the gauze wrapped drain in the wound cavity. If needed, fluff additional saturated gauze into the wound to completely cover the drain and loosely fill the wound with gauze to skin level.

Warning: Do not overlap the gauze onto intact skin. Warning: Do not overpack gauze into any area of the

wound, as this may maintain the wound cavity, damage tissue, hinder exudates removal or hinder delivery of negative pressure.

Warning: If more than one sheet of gauze is used,

always count the total number of sheets used in the dressing and document in the patient’s notes. Ensure contact between all sheets of gauze for even distribution of negative pressure.

8. Avance Transparent Film application 8.1

Cut the film if necessary to desired size allowing an overlap of 3-4 cm onto surrounding skin. If larger wounds are treated, two or more films may be required, overlapping each other where they meet. If appropriate, adhesive promoting and sealing accessories may be used to ensure air and fluid tightness.

Warning: If certain skin protection products e.g. zinc

paste or skin lotions have been applied to the patient’s skin prior to application of the film, the adhesion level on the skin may be negatively affected.

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8.2

Remove the protection paper from the green bar numbered “1” to expose the adhesive. If the film has been cut, do not completely remove the protection paper. Instead, use it as grip/handling bar to assist the film application.

8.3

Apply the film over the wound filler, starting on top of the wound filler (1), following the contours, without stretching the film, out towards the surrounding skin (2).

Warning: Stretching of the film during application

may cause damage to surrounding skin once negative pressure is applied.

8.4

When reaching the drain, lift the drain and squeeze the film around it to create an airtight seal. Make sure that the film adheres to itself properly underneath the tubing.

8.5

Once the film has been secured around the drain, attach the film onto the underlying skin and then wiggle the drain gently back and forth while applying light pressure to the skin in order to secure an airtight seal.

8.6

Remove the transparent carrier film using the green bar numbered “2”.

8.7

Tear off the paper handling bars at the perforated edges.

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Avance Pump

Suction port Canister release button

Canister 300 ml

Specification plate

Information field / Therapy timer

Holder for bed

Standard rail holder

Display

Electrical outlet port

Therapy number Intermittent / Constant Power

Battery charging status

Run / Standby indicator Selection buttons

Display field Instructions / Alarms Navigation field “Soft” buttons

10

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Initial Pump Delivery and Set-up Do not switch on Avance pump before first battery charge! 1. Charge battery for the first time. Connect Avance Pump to electrical outlet, battery is being charged. after max. 3h Battery is being charged

Battery is fully charged

The battery must be fully charged before first use. a)

To disconnect Avance Pump from the electrical source:

Release the plug's safety lock by pulling only on the plug's hard housing.

Do not pull on the cable or the anti-bend protection! b)

Avance Pump switches off automatically.

If Avance Pump was switched on before battery was fully charged (step 2), follow the instruction on the display. 2. Select language. a)

Switch Avance Pump ON with [

> 3 sec] , self test starts.

b)

Select language (by following instructions on display), confirm with “Ok”.

3. Select time zone. a)

b)

Select the time zone you are in. Refer to the chart in the back of the instructions. Switch Avance Pump OFF with [

> 3 sec.].

Avance Pump is now ready for use.

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Avance Pump Disposables Canister with solidifier 300 ml and 800 ml

Safety chamber

Overflow protection / Bacteria filter

Sealing cap

Fluid chamber Capacity 300 ml and 800 ml

Double lumen tubing with single connection / Y-connector Clamp Connection to pump Measuring tubing Suction tubing

Patient connection single

Y-connector

12

Connection to canister

Preparation for Use Use only after instruction by trained personnel. Wear gloves for all operations. “Pressure“ generally implies “negative pressure”

1

Check necessary parts. • Avance Pump

• Avance Tubing

• Avance Canister (usable capacity in

upright position 300 ml/800 ml)

2

Connect Avance Tubing. Open external packaging. Insert the tubing base into the pump as shown (straight push).

3

Click in Avance Canister. Unpack the canister and slip the bottom of the canister into the pump first. Then rotate and "click" into place.

click

Canister secures tubing.

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Avance Pump User Modes Administrative mode Used by clinicians to either set up new patients or to change pump settings like pressure, switch from constant to intermittent mode, change intermittent time settings, language, time zone.

Patient mode Used by patient to switch Avance Pump off and on. When the pump is being turned on in this mode, all the settings will default to the prior settings used.

Administrative Mode 1. In accordance with the physician's directions,

connect drain tubing to the suction tubing.

The therapy number is displayed in the information field. 2. Switch ON Avance Pump. Enter in the administrator's mode to assign a new therapy number to your patient and/or to change the settings press and hold [ ], press [ ].

Self-test starts.

If the self-test is not successful, see chapter Alarms. 3. Acknowledge disclaimer.

4. New patient? Yes/No • “Yes” means that Avance Pump will issue a new therapy number (= new patient). This number can be noted in the patient's file. • “No” means that the therapy number remains unchanged (= same patient).

The therapy number is displayed in the information field.

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5. Set pressure levels The pressure level shall be set according to clinician’s instruction based on the indication, the condition of the wound, the objective of the treatment and which wound filler material is being used. For guidance, foam dressings may employ -120 mmHg and gauze dressings -80 mmHg.

constant

With the “soft” buttons choose the desired vacuum and confirm with “OK”. If the values are not confirmed, they will switch back to the old values.

hold

change pressure

or

change pressure

and press

intermittent

hold

or

and press

6. Switch Avance Pump on. • Constant mode Switch on pressure with the “On” button – the pre-selected pressure is built up and kept constant. (for Change pressure value, see chapter Change Settings.)

• Intermittent mode Choose "change to intermittent" and turn on with “On” button - the pre-selected pressure is built up and the pre-selected times are used. (see chapter Change Settings.)

1 minute after the last button has been pressed, the Avance Pump switches into the patient mode automatically.

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Conduct functional check to ensure adequate seal 1. Seal off the conical connector of the tubing with your thumb (through the packaging).

Ensure tubing is not bent during the functional check. 2. Switch Avance Pump ON by pressing [ ]. The pump will do self-test and start running immediately. You should hear the motor running for a short time until the pressure is built up. If the motor keeps running for more than 30 sec. – check system and retry. 3. If functional check was successful, switch off Avance Pump by pressing [ > 3 sec.].

Connect Avance Drain to Avance Canister and Tubing 1. Attach the drain to the canister tubing.

Note. If you are treating two wounds simultaneously, a Y-connector is available from Mölnlycke Health Care

2. Once negative pressure is applied, the dressing will have a wrinkled “raisin-like” appearance and be firm to the touch. If the dressing does not contract, the system may not be closed. Inspect the dressing and reseal if necessary. If problem persists, troubleshoot in accordance with the air leak checklist below. If necessary, replace dressing. Air leak checklist: • Seal (loose) • Connectors (unfastened) • Tubing (kinked) • Pump settings (below desired setting) • Canister (cracked) Ensure that the wound cavity is sufficiently filled with foam or gauze without overpacking. When negative pressure is applied, there should be no visible area without wound filler material in the wound cavity. If there is, make a small incision in the film and fill with additional wound filler material. Cover the incision with additional film to secure an airtight seal.

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Change Settings The settings can only be changed when the pump is in the administrative mode (see chapter Administrative Mode). Changing pressure levels Enter the administrative mode by pressing and holding [ ] and then pressing [ ]. You can always enter the administrative mode (in both standby and running modes). With the “soft” buttons choose the desired vacuum and confirm with “OK”.

constant

If the values are not confirmed, they will switch back to the old values.

hold

change pressure

or

change pressure

and press

intermittent

hold

or

and press

Controlling On/Off times In order to control On/Off times, enter the administrative mode (see page 12). Avance Pump logs the On/Off times, the pressure setting and the mode (constant or intermittent). In order to view this data, press the buttons [ ], and [ ] simultaneously.

press at the same time

List

Graph

30 seconds after the last button has been pressed, the Avance Pump switches into the administrative mode automatically. After another 30 seconds, the patient mode is reactivated.

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EN17

Adjust settings

The settings can only be changed when the pump is in the administrative mode (see chapter Administrative Mode). 1. Press the “soft” buttons [

Press at the same time

+

] at the same time.

Press at the same time

+

2. To change setting, choose with the “selection buttons” [

] or [

+

].

Selection -60 to -200 mmHg (-8 to -27 kPa) kPa / mmHg 1 – 8 min. 1 – 8 min. Languages according to list

Selection

+-0 – 12 hours GMT as displayed as displayed as displayed

3. Press “OK” [

] to select.

4.

or

5. Press “OK” [ 6. Press “Back” [

18

change setting

] to confirm. ] to exit settings.

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Frequency of Change Dressing change and removal Dressings should be changed three times per week or according to clinician’s instruction. When treating infected wounds or wounds more susceptible to tissue in-growth into wound filler material, more frequent dressing changes may be needed. The frequency of dressing changes should be based on an evaluation of the wound condition rather than standard recommendations. Remove the film by gently pulling it along the skin (in the direction of hair growth). Gently remove the foam or gauze from the wound. If adherence of wound filler to wound bed is observed, consider moisten the filler material with normal saline or sterile water. Prior to next dressing application, consider the use of a wound contact layer (e.g. Mepitel) to avoid tissue in-growth and wound bed adherence. If the patient is not comfortable or experiences pain during dressing removal, consider the use of pain relief medication, per clinician’s instruction, in conjunction with dressing changes. Always make sure that no pieces or fragments of wound filler material or wound contact layers are left in the wound.

Avance Canister and Avance Tubing change and removal - on the basis of a visual check - according to the instructions in the display/alarm signal – or at every dressing change

5

1.

Provide sterile canister and sterile tubing.

2.

Clamp tubing.

3.

Switch off pressure with the “Standby” button (press for > 3 sec.).

4.

Disconnect tubing.

5.

Release and remove canister.

EN19

6

6. Remove tubing in direction of the arrow (see picture). 7.

8

11

20

Unpack new tubing.

8. Unpack new canister, position and click into Avance Pump. 9.

Press “On”. Pressure is built up.

10.

Unclamp patient tubing.

11. Seal used canister and dispose both, canister and tubing in accordance with disposal procedures of the facility.

Alarms Avance Pump distinguishes between faults/warnings and alarms. If Avance Pump detects any of these situations, an acoustic warning signal sounds and a description of the problem appears on the display. By pressing the two selection buttons simultaneously, the acoustic alarm is suppressed for 60 sec. Hints on troubleshooting appear on the display.

Internal fault

Warning

Alarm

The problem cannot be corrected by the user. The fault number is displayed.

(Operation continues)

(Operation halts)

beep

✔

beep

✔

beep beep beep

Problem description on the display Example:

Press at the same time

Acknowledge and mute acoustic alarm (60 sec.)

Fault number Troubleshooting on the display

Note the fault number, then switch off the pump. Contact Mölnlycke Health Care Customer Service if fault message repeats.

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