RENASYS GO User Guide for use with Soft Port Jan 2012

User Guide

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File Name: renasys_go_user_guide_for_use_with_soft_port_jan_20.pdf

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User Guide User Guide For use with Soft Port

*smith&nephew RENASYS™ GO Negative Pressure Wound Therapy

300ml 200ml 100ml 50ml

NPWT Customer Care Details Country

Customer Care Center

Advice/Service Details

United States

Smith & Nephew, Inc. 970 Lake Carillon Drive Suite 110 St. Petersburg, FL 33716 USA

Tel: +1 800-876-1261 Fax: +1 727-392-6914 customercare.largo@ smith-nephew.com

24/7 NPWT Clinical Support Hotline

1-800-876-1261

User Guide

Table of Contents Introduction

Turn off the device

Indications for use

Modes of operation

Contraindications

Clinician information – therapy time

Warnings

Dressing changes

Precautions

Clinician information – total time

Glossary of symbols

Clinician information – battery charge

Physician orders

Battery power

Canister selection

Alarms/troubleshooting guide

Installing the canister

Accessories

Removing or changing the canister

Maintenance

Initiate therapy

Electromagnetic compatibility

Start up of device

Specifications

Language selection

Cautions

Starting therapy

Limited warranty

Pause/adjust therapy

Customer assistance

Lock or unlock the keypad

Introduction This user manual contains important information regarding the safe and effective operation of the RENASYS™ GO Negative Pressure Wound Therapy (NPWT) system. This manual is intended to aid in the training of personnel and to provide a reference for experienced users. Also included are instructions for commissioning the device, preventive maintenance, cleaning and disposal.

Features and Functions Status Light Power Button

Display

Battery Indication

Up and Down Selectors

Start Therapy

Keypad Lock Inlet Port

Audio Pause

Canister (300ml and 750ml Large Canister) (300ml canister is shown here)

Canister Clips 300ml 200ml 100ml 50ml

End Caps

Quick Click Connector

Canister Tube

Power

Power Jack Point

Power Supply with DC Cord

Accessories Carry Bag

Strap

(available for 300ml canister)

5. In the event defibrillation is required, disconnect

RENASYS™ GO is a portable Negative Pressure Wound Therapy (NPWT) device. It is designed to be used with Smith & Nephew Power Supply (Product Code 66800161 or 66800696). Smith & Nephew Wound Dressing Kits are required for the proper and effective use of the RENASYS GO device.

the device from the wound dressing prior to defibrillation. Remove the wound dressing only if its location will interfere with defibrillation.

6. RENASYS devices are not MRI compatible. Do not bring the RENASYS device into the MRI suite.

Indications for Use

7. When operating, transporting, repairing or disposing

RENASYS GO is indicated for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials.

of RENASYS devices and accessories, the risk of infectious liquids being aspirated, or contamination of the device assembly through incorrect use, cannot be eliminated. Universal precautions should be observed whenever working with potentially contaminated parts or equipment.

Examples of appropriate wound types include: • Chronic • Acute • Traumatic • Sub-acute and dehisced wounds • Ulcers (such as pressure or diabetic) • Partial-thickness burns • Flaps and grafts

8. NPWT has not been studied on pediatric patients. Patient size and weight should be considered when prescribing RENASYS devices.

9. RENASYS devices are unsuitable for use in areas where there is danger of explosion (e.g., hyperbric oxygen unit, or in the presence of a flammable anesthetic mixture with air or nitrous oxide). Disconnect the device from the dressing prior to entering an area where this equipment will be used.

Contraindications The use of NPWT is contraindicated for: • Untreated osteomyelitis • Exposed arteries, veins, organs or nerves • Necrotic tissue with eschar present • Malignancy in wound (with exception of palliative care to enhance quality of life) • Non-enteric and unexplored fistulas • Anastomotic sites

10. Canister kits are provided non-sterile and should not be placed within a sterile field.

Precautions 1. Precautions should be taken for patients who are

Warnings

or may be:

1. Carefully monitor patients for signs of sudden

- Receiving anticoagulant therapy or platelet aggregation inhibitors, actively bleeding or have friable blood vessels or organs

or increased bleeding. If such symptoms are observed, immediately discontinue therapy, take appropriate measures to control the bleeding, and contact the treating clinician.

- Suffering from abnormal wound hemostasis - Untreated for malnutrition

2. Patients suffering from difficult hemostasis or

- Noncompliant or combative

who are receiving anticoagulant therapy have an increased risk of bleeding. During negative pressure therapy, avoid using hemostatic products that may increase the risk of bleeding.

- Suffering from wounds in close proximity to blood vessels or delicate fascia.

2. CT scans and x-ray have the potential to interfere with some electronic medical devices. Where possible, move the device out of the x-ray or scanner range. If the device has been taken into the CT scan or x-ray range, check that it is functioning correctly following the procedure.

3. Do not use on exposed blood vessels or organs. Sharp edges such as bone fragments must be covered or removed prior to initiating therapy due to risk of puncturing organs or blood vessels drawn closer under the action of negative pressure.

4. Foam or gauze must not be tightly packed or forced into any wound area. 6

3. As a condition of use, the RENASYS™ device

the location of the wound, the volume of drainage, the integrity of the dressing seal, the assessment of bacterial burden and the patient's risk of infection.

should only be used by qualified and authorized personnel. The user must have the necessary knowledge of the specific medical application for which NPWT is being used.

13. Ensure that tubing and Soft Port is installed completely and without any kinks to avoid leaks or blockages in the vacuum circuit. Position the RENASYS device and tubing appropriately to avoid the risks of causing a trip hazard. Whenever possible, the device and system tubing should be positioned level with or below the wound.

4. If the RENASYS device has been at temperatures below freezing the device must be brought to room temperature prior to use or the pump unit may be damaged.

5. Inspect the Bacterial Overflow Guard on the

14. When bathing or showering, the patient must

canister and replace the canister as necessary. At minimum, the canister should be changed weekly. Always use the smallest canister volume possible – do not use a large canister on patients with a high risk of bleeding.

disconnect from the RENASYS device and should protect both ends of the tubing using the tethered caps. Ensure that the aeration disc, located near the Quick Click Connector, is free of excess moisture before reactivation of therapy.

6. If any liquids penetrate the RENASYS device,

15. NPWT should not be painful. If the patient reports

discontinue use and return to your authorized provider for service.

discomfort, consider reducing the pressure.

7. Do not use a dressing kit with breached or

16. Maintain regular monitoring of the RENASYS

damaged packaging.

device and wound site during therapy to ensure therapeutic treatment and patient comfort.

8. The use of NPWT presents a risk of tissue in-

17. As with all adhesive products apply and remove

growth. Tissue in-growth may be reduced by reducing therapy pressure, using a wound contact layer or by increasing the frequency of dressing changes.

the dressing carefully from sensitive or fragile skin to avoid skin stripping, especially after frequent dressing changes.

9. Underlying structures, such as tendons, ligaments

Precaution specific to foam:

and nerves should be covered with natural tissue or a non-adherent dressing layer prior to applying the NPWT dressing kit.

1. Foam should be cut to fit loosely into the wound bed. Never force or tightly pack foam into any areas of the wound to avoid damaging underlying tissue.

10. If multiple pieces of foam or gauze are needed to

2. Never place foam into blind or unexplored tunnels.

fill the wound profile, count and record how many foam pieces are present to ensure all the foam pieces are removed at a dressing change.

If a tunnel of known depth presents, cut the foam longer than the tunnel, to ensure direct contact is made with the foam in the primary wound cavity.

11. Infected wounds may require more frequent dressing

3. Do not cut the foam directly over the wound cavity

changes. Regular monitoring of the wound should be maintained to check for signs of infection.

to avoid foam fragments from falling into the wound. Rub the edges of the foam, away from the open wound, to remove loose fragments after cutting.

12. NPWT should remain on for the duration of the treatment. If the patient must be disconnected, the ends of the tubing should be protected using the tethered cap. The length of time a patient may be disconnected from the RENASYS device is a clinical decision based on individual characteristics of the patient and the wound. Factors to consider include

Glossary of Symbols Power Button Turns the device on and off.

Keypad Lock Locks the keypad to restrict accidental adjustment of therapy. When activated the light will illuminate.

Battery Indication Shows the status of battery life. Flashes when the battery life reaches levels that require user intervention.

Audio Pause Silences the alarm for approximately 2-3 minutes. When activated the light will illuminate and flash.

Up Selector Allows the pressure setting to be increased and scroll through menu options.

If a new alarm occurs, the Audio Pause will cancel. (This feature available with software version 0.66 and later.)

Start Therapy/Select Allows therapy to be started or paused. It is also used to confirm settings within therapy.

Down Selector Allows the pressure setting to be decreased and scroll through menu options.

Equipment Classification Isolation type BF applied part

Single Use do not reuse

European Representative

CSA International Classification

Keep Dry

Lot Number

EU: not for general waste

Storage Temperature

Serial Number

Caution: see instructions for use

Date of Manufacture

Product Catalogue Number

Place of Manufacture

CE Mark

Physician orders

Removing or Changing the Canister Hold the Quick Click Connector above the wound to allow gravity to help ensure exudate does not leak from the tubing.

Prior to placement of RENASYS™ GO, the medical professional treating the wound must assess how to best use the system for an individual wound. It is important to carefully assess the wound and patient to ensure clinical indications for NPWT are met. All orders should include: • Wound location, size and type • Smith & Nephew wound dressing kit type

Turn the device off.

Disconnect the canister tube from the dressing tubing.

Cap off both sides of the tubing connector.

Release the orange canister clips on either side and gently pull away from the device

• Vacuum settings

Disposal of used canisters should follow facility protocols or local ordinances relating to the handling of potentially infected or bio-hazardous materials.

• Frequency of dressing changes • Adjunctive dressings

Canister Selection

Canister tubing

The RENASYS GO device can only be used with the 300ml RENASYS GO Canister and the RENASYS GO Large Canister (750ml). The canisters are designed for single patient use. DO NOT REUSE.

Connect the tubing

The canister should be changed at least once a week or when full. Canisters may have to be changed regularly within single-patient treatment episodes if exudate levels are high.

Connect the RENASYS Soft Port to the canister tubing by pushing the Quick Click Connectors together. An audible click indicates the connection is secure.

Activate the RENASYS device and adjust to the prescribed therapy level. The recommended therapeutic pressure range is 40-80mmHg for gauze, and 80-120mmHg for foam.

Finished dressings should be firm to the touch and leak-free.

Canister kits are provided non-sterile and should not be used in a sterile field.

Installing the Canister Turn the device off. Remove paper tape around the canister tubing to release tubing to the full length. Open both of the orange clips. Align the canister so that the Volume marks are facing forward. Push the canister gently over the inlet port of the device. Engage both orange clips (will click when they are properly engaged).

3. 4. 5. 6.

*smith&nephew RENASYS™ GO Negative Pressure Wound Therapy

Notes: The vacuum level is a decision each healthcare provider must make, based on an individual assessment of the particular wound. Adhere to the following general guidelines: Lower levels of vacuum are generally effective and more tolerable. The vacuum level should never be painful. If the patient reports discomfort with the vacuum level, it can be reduced.

*smith&nephew RENASYS™ GO Negative Pressure Wound Therapy

300ml 300ml 300ml 200ml 100ml

200ml 100ml

Cap the tubing

Initiate Therapy

If the canister shows any sign of damage, discard and use a new canister.

1. 2.

Disconnect the tubing

200ml 100ml 50ml

50ml

Start Up of Device

Setting the vacuum level is a decision that the healthcare provider must make based on an individual assessment of the particular wound. These general guidelines should be adhered to:

The device operates on both battery and AC power. If battery operation is required for first use of the device, the battery must be charged from AC power until the green battery indicator light is constantly illuminated. During the charging process the light will flash green. If AC power is required, connect the power supply to the jack input port, on the side of the device. Press the Power device will show:

•

40-120mmHg is the recommended therapeutic pressure range.

•

Lower levels of vacuum are generally effective and more tolerable.

•

The vacuum level should never be painful. If the patient reports discomfort with the vacuum level, it should be reduced.

button for 2 seconds and the

The device will show the set pressure level. Operation outside of this will result in an alarm.

W e l c o m e S t a r t i n g

V X X . x

Caution: Before starting therapy ensure that the device is located no more than 19in or 50cm higher than the wound and is away from any direct sources of heat.

Language Selection: To change the language at anytime

Pause/Adjust Therapy

Turn off the device.

Therapy may be paused and restarted by pressing the

Simultaneously press the Up

+ Select

Select

will show a standby message on the display and the

+ Power

therapy level can be changed using the

buttons for 2 seconds. 3.

and Down

the Select 4.

Language can now be selected using the Up

Lock or Unlock the Keypad

button at this point will

To lock the user interface when the device is active press the Keypad Lock

Starting Therapy

K e y p a d L o c k e d ► 8 0 mmH g

button for 2 seconds and the

If after 10 minutes the keypad on the user interface has not been used, the keypad is automatically locked.

V X X . x

If after 10 minutes in active mode the keypad on the user interface has not been used, the keypad is automatically locked. (This feature available with software version 0.66 and later.) The blue light above the keypad lock button will illuminate.

S t a n d b y ► 8 0 mmH g

•

button for 2 seconds

and the blue light will illuminate.

W e l c o m e S t a r t i n g

To select the prescribed vacuum setting, use the Up

buttons.

S t a n d b y ► 8 0 mmH g

buttons followed by

start therapy at preset 80mmHg in continuous mode.

•

and Down

button.

Pressing the Select

Press the Power device will show:

button once. When paused, the device

and Down

Press the Select start.

To unlock the user interface press the

buttons.

Keypad Lock

button and therapy will

button again for 2 seconds.

K e y p a d A c t i v e ► 8 0 mmH g

C o n t i n u o u s ► 8 0 mmH g

Note: Locking the keypad only locks the bottom rows of keys – the Power Button is not locked.

Turn off the device Press the Power

The display will show for 6 seconds and then return to main menu.

button for 2 seconds and the

To reset the time:

device will power off.

Modes of Operation

C l e a r ►T i m e ?

In the Intermittent mode, the device cycles on and off in increments of 5 minutes “ON” (active vacuum) and 2 minutes “OFF” (no vacuum).

Simultaneously press the + Select

Down

+ Power

Press the Up

or Down

buttons to

button to confirm.

Press the Down

button to move to yes and

press the Select

button.

Once the Select

button has been pressed,

Total Time This feature available with software version 0.66 and later.

Therapy Time

The device displays the total number of hours accumulated in active mode. This time cannot be reset.

The device displays information which will allow the clinician to see how much therapy time (total hours and minutes of Continuous or Intermittent therapy) has been delivered to the patient.

To access this display the following steps need to be taken:

Turn off the device.

Simultaneously press the Down + Power

Turn off the device.

Simultaneously press the Down

button again to confirm

The Active Time on therapy should be cleared between patients. This will allow the clinician to monitor patient/ therapy compliance.

Once therapy is started the display will show which mode of therapy has been selected.

Clinician Information

Press the Select

A c t i v e T i m e C l e a r e d

move between Continuous and Intermittent mode and press the Select

A c t i v e

the device will show the following message for 5 seconds before returning to the main menu:

buttons for 2 seconds. 3.

button has been pressed,

that you want to clear active time.

To change the therapy between Continuous and Intermittent mode:

Once the Select

button.

the device will show the following:

Note: Continuous mode is recommended for NPWT. In the Continuous mode, the device will maintain the selected vacuum level without stopping until switched off.

Turn the device off.

button to move to clear

time and press the Select

There are 2 modes of operation - Continuous and Intermittent.

Press the Down

+ Select

+ Power

buttons for 2 seconds.

Press the Down

button to show time and

button to show total

Once Select

has been pressed the device

will show the following screen:

press Select

Once Select

has been pressed the device

T o t a l x x x x x

will show the following screen: A c t i v e T i m e x x x x x H , x x

Press the Down time and press Select

+ Select

buttons for 2 seconds.

T i m e H

The display will show for 6 seconds and then return to main menu.

Dressing changes

Battery Charge

This feature available with software version 0.66 and later.

RENASYS™ foam dressings should be changed every 48-72 hours after the inital application of therapy. If no leak is present and the patient is comfortable, dressing changes should occur no less than 3 times per week.

The device displays the percentage of battery charge remaining. To access this display the following steps need to be taken:

RENASYS gauze dressings should be changed 48 hours after the inital applicaiton of therapy. If no leak is present and the patient is comfortable, dressing changes should occur 2-3 times per week. 2.

Check the dressing regularly. Throughout treatment, monitor the patient for any signs of local or systemic infection. Infected wounds may require more frequent dressing changes. If there are any signs of systemic infection or advancing infection at the wounded area, contact the treating clinician immediately.

Simultaneously press the Down

+ Select

+ Power

buttons for 2 seconds.

Press the Down

button to show battery

charge and press Select Once Select

has been pressed the device

will show the following screen:

Ensure that all wound filler material placed in the wound has been removed before redressing the wound. If foam dressing adheres to the wound, apply normal saline into the wound dressing and let it set for 15-30 minutes before gently removing the foam. Appropriately discard used wound dressings observing your institution's protocol for medical waste handling. As with all adhesive products, apply and remove the dressing carefully from sensitive or fragile skin to avoid skin stripping, especially after frequent dressing changes.

Turn off the device.

In the event of heavy drainage or drainage with sediment, more frequent dressing changes may be needed.

B a t t e r y x x x %

C h a r g e

The display will show for 6 seconds and then return to main menu.

Battery Power The device can be used on battery power to allow the user greater mobility. A fully charged battery will last up to 20 hours. During therapy, if the battery indicator shows that the battery life is getting low, the power adaptor can be plugged into an electrical (AC) outlet, without causing interruption in therapy and the battery will recharge Battery Status Indication RENASYS GO contains a lithium ion rechargeable battery good for approximately 300-500 recharges. There are several battery level indicators on the RENASYS GO device.

If the RENASYS device reports a blockage alarm, inspect the dressing and canister tubing for any blockages which may be manually remedied. If a blockage cannot be identified or resolved, replace the device canister first, then replace the dressing and Soft Port as necessary.

Indicator

Battery Level

Action

The Battery is fully charged and has up to 20 hours therapy time remaining. Indicator shows a solid green light.

No action required.

The battery has up to 10 hours therapy time remaining. Indicator shows a flashing green light.

No action required.

The battery has up to 6 hours therapy time remaining. Indicator shows a solid amber light and flashing green light.

No action required.

A t t e n t i o n L o w B a t t e r y

The Battery has up to 3 hours therapy time remaining. The indicator will show amber light. The display will show message and audible alarm will sound.

Audio alarm can be paused by pressing the Audio Pause button on user interface. Plug device into AC power to start charging.

R E C H A R G E V . L o w B a t t e r y

The battery has up to 1 hour therapy time remaining. The indicator will flash amber light. The display will show message and audible alarm will sound.

Device should be plugged into the AC power as soon as possible.

The battery has only 2 minutes of therapy time remaining. The indicator will flash amber light. The display will show message and the audible alarm will sound continuously for 2 minutes.

Device should be plugged into the AC power immediately.

After 2 minutes in the extremely low state the device will power off.

Plug device into AC power.

When plugged into AC power for charging the display will show “Charging” message and the indicator will flash green.

No action required. The device may take up to 3 hours to charge.

The battery unit within the device has failed.

Therapy can only be continued by keeping the device plugged into AC power.

B a t t e r y F u l l ► 8 0 mmH g

! !

! ! ! !

! ! R E C H A R G E ! ! E X . L OW B A T T E R Y

! ! ! !

R E C H A R G E N OW ! B A T T E R Y F A I L

C h a r g i n g ► 8 0 mmH g

! ! B A T T E R Y F A I L E D ! ! ►1 0 0 mmH g

NOTE: This will only display when connected to AC power.

Contact your authorized Smith & Nephew representative to obtain a replacement device.

This feature available with software version 0.66 and later.

Caution: Keep device away from direct heat source during charging. 13

Alarms/Troubleshooting Guide

Alarm

Display Message

Description

Cause

Remedy

Low Vacuum

The vacuum level is low or there is a leak in the system for longer than 30 seconds.

There is a leak in or around the dressing site.

1. Check dressing for inconsistencies such as creases, crevices or skin folds.

! ! ! !

Audible alarm will sound every 10 seconds.

WA R N I N G L OW V A C U U M

2. Look for partial seals in the drain exit, around both the wound and transparent dressings.

• Status light will flash amber.

3. Listen for the movement of air at the wound site.

• If the system is sealed the alarm will reset automatically. ! ! ! !

A U D I O P A U S E D L OW V A C U U M

! ! ! !

T H E R A P Y S T O P L OW V A C U U M

4. Feel for the movement of air in or out of the wound site.

• Audible alarm may be paused for approximately 2-3 minutes.

5. If a leak is found, seal using the following techniques:

• The device will stop delivering therapy after pausing 5 times, without correcting vacuum.

a. Cover the leak with waterproof tape. b. Apply increased amounts of transparent dressing. c. Use ostomy strip paste to seal the leak. There is a leak or defect in the connective tubing between the wound site and the device.

1. Disconnect the dressing tube from the Quick Click Connector and insert the end cap into the Quick Click Connector. 2. If the alarm clears, the issue is within the wound dressing site (see above) or the Quick Click Connector. 3. Ensure that the Quick Click Connector is fully and correctly connected.

Alarm

Display Message

Description

Cause

Remedy

There is a poor seal at the canister to device connection.

1. Switch off the device and check that the canister is correctly fitted. Restart the device. 2. If the above does not correct the alarm, carefully examine the inlet connector to the device and O-ring (see diagram of device page 4 "inlet port"). If there is any damage to this area, return the device to your Smith & Nephew authorized representative.

High Vacuum

The system has encountered a high vacuum condition.

! ! ! !

• Audible alarm will sound every 10 seconds.

WA R N I N G H I G H V A C U U M

• Status light will flash amber. • This audio alarm can not be paused and must be investigated by healthcare provider immediately and corrected. • Once corrected the audio alarm will automatically reset and the status light return to green.

Device has detected a high vacuum condition potentially due to line blockage or device malfunction.

1. Put the device into Standby mode. 2. Check that all lines are open and clear of blockages. 3. Check that the canister is not full. 4. If alarm still sounds, replace the canister with a new one. 5. If the error alarm recurs, there is a potential malfunction of the device. Contact your Smith & Nephew authorized representative.

Alarm

Display Message

Over Vacuum

! ! ! !

T H E R A P Y S T O P O V E R V A C U U M

Description

Cause

Remedy

The system has encountered an excessively high vacuum (of >235mmHg).

Pump has potentially malfunctioned and has reached an excessively high vacuum level.

1. Switch off and restart the device.

Blockage in tubing, canister full or the internal filter of the canister is covered with exudate.

1. Ensure tubing clamp is open.

• The vacuum safety switch will operate and the device will stop delivering therapy. • The audible alarm will sound every 10 seconds.

2. If the error alarm recurs, there is a potential malfunction of the device. Contact your Smith & Nephew authorized representative.

• The status light will flash amber.

Blockage/Canister Full

Note: The RENASYS™ GO Blockage/Canister Full alarm will detect blockage from the T-Piece to the canister. ! ! ! !

WA R N I N G B L O C K A G E / F U L L

The system detects that the canister is full or that there is a blockage in the system. • Audible alarm will sound every 10 seconds. • Status light will flash amber. • There will be no negative pressure at the wound site. • If the problem is cleared, the alarm will reset automatically.

! ! ! !

A U D I O P A U S E D B L O C K A G E / F U L L

! ! ! !

T H E R A P Y S T O P B L O C K A G E / F U L L

• Audible alarm may be paused for approximately 2-3 minutes. • The device will stop delivering therapy after pausing 5 times, without correcting vacuum. • After 5th time of pausing and problem has not be corrected, the device will stop delivering therapy.

2. Check for tube blockage (tube kinking, sediment blockage or fluid build-up in the tubing due to the tubing/canister being higher than the wound). 3. Ensure canister is not full or the internal overflow guard of the canister is not covered with exudate.

Alarm

Display Message

High Flow/Leak Alarm

! ! ! !

WA R N I N G L E A K

Description

Cause

Remedy

The system has detected a significant leak for more than 1 minute:

There is a leak in or around the dressing site.

1. Check dressing for inconsistencies such as creases, crevices or skin folds.

• Alarm will sound every 10 seconds.

2. Look for partial seals in the drain exit, around both the wound and transparent dressings.

• Status light will flash amber. • If the system is sealed, the alarm will reset automatically.

! ! ! !

A U D I O L E A K

P A U S E D

3. Listen for the movement of air at the wound site.

• Audible alarm may be paused for approximately 2-3 minutes.

4. If a leak is found, seal using the following techniques: a. Cover the leak with waterproof tape. b. Apply increased amounts of transparent dressing. c. Use ostomy strip paste to seal the leak. There is a leak or defect in the connective tubing between the wound site and the device.

There is a poor seal at the canister to device connection.

1. Switch off the device and check that the canister is correctly fitted. Restart the device. 2. If the above does not correct the alarm, carefully examine the inlet connector to the device and O-ring (see diagram page 4 "inlet port"). If there is any damage to this area, return the device to your Smith & Nephew authorized representative.

Alarm

Display Message

Inactive This feature available with software version 0.66 and later. ! ! ! !

A t t e n t i o n I N A C T I V E

! ! ! !

A U D I O P A U S E D I N A C T I V E

Description

Cause

The device has been left in standby mode for longer than 15 minutes. • Alarm will double beep every 30 seconds. • Status light will flash amber.

The device has been left in standby mode without any keys being pressed for longer than 15 minutes.

Remedy Either select vacuum setting and start therapy or shut off the device until therapy is required.

• Audible alarm may be paused for 15 minutes. • Alarm can only be paused once.

Battery

See the battery status section of the manual for screen messages

Battery partially discharged or depleted.

Plug unit into AC power to charge the battery.

User interface is locked.

Unlock by pressing the keypad lock button for 2 seconds.

The device has an unrecoverable error.

Internal hardware or software error.

Contact your Smith & Nephew authorized representative.

The device will not operate.

Service and repair required.

Contact your Smith & Nephew authorized representative.

Battery Failure

The battery within the device has failed.

Internal hardware failure.

This feature available with software version 0.66 and later.

• Alert message will display.

Contact your Smith & Nephew authorized representative for a replacement device.

! ! B A T T E R Y F A I L E D ► 1 0 0 mmH g

• Indicator will flash amber.

NOTE: This will only display when connected to AC power.

• Therapy can only be continued by keeping the device plugged into AC power.

Keypad Lock On K e y p a d L o c k e d ► 8 0 mmH g

Device Failed ! ! ! !

D E V I C E P l e a s e

F A I L E D R e t u r n

Device Not Calibrated ! ! ! !

D E V I C E N O T C A L I B R A T E D

Alarm Blockage *smith&nephew RENASYS™ GO

Description

Cause

Remedy

A blockage has been detected.

Blockage within canister, Quick Click Connector or dressing.

Refer to diagram and begin the diagnosis algorithm below.

Pump suction increases.

Blockage is located in Quick Click Connector or dressing.

Examine the dressing.

Nothing happens.

Blockage is within canister.

Examine the canister.

Canister tubing is obstructed.

Flush with sterile saline, massage the tubing to break apart, or simply replace the canister.

Canister tubing is clear.

If canister is full or almost full, replace it.

Negative Pressure Wound Therapy

300ml 200ml 100ml 50ml

Canister

These steps apply to both the RENASYS™ EZ/EZ-Plus and RENASYS GO systems.

Keep in mind, blockage alarm from device may take up to 30 seconds to clear.

Quick Click Connector

1. Detach the Quick Click Connector

2. Examine the canister

Canister filter is wet.

Turn off device. Release vacuum. Remove canister from device. Gently tap canister to remove excess fluid. Reattach ETSI INTERNAL TRACKING INFORMATION. Please disregard. March 16, 2011 canister. File: /Volumes/Art/Smith&Nephew/RENASYS GO/Service and Repair Module/9 seal.eps If effective alarm dressing sounds, replace canister. 3. Examine the dressing

The Quick Click lumen is blocked.

Flush with sterile Blockage is deeper saline, or attempt within Soft Port. Flush to mechanically with sterile saline. clear the blockage.

Aeration disc is blocked by tape or wet.

Remove tape or dab the aeration disc dry.

Replace Soft Port.

Accessories Carry Strap The carry strap is designed to be a single patient use item.

Once both sides are connected to the device they can be joined together to make the short carry strap. The short carry strap can be used to attach the device to a wheelchair or IV pole when moving patients.

To attach the carry strap to device: 1.

Feed end of open strap behind location pin.

Pull the strap through and feed the end behind the clip.

Close clip to secure strap.

Repeat steps 1-3 on other side of device.

Extension Strap The strap can be extended to allow the device to be carried on the shoulder or across the body. Place the padded section of the strap against shoulder for maximum comfort when carrying device.

Carry Bag (available for the 300ml RENASYS◊ GO Canister) The carry bag is designed to be a single patient use item.

Once fitted ensure the canister tubing can move freely.

To place the device into the bag:

Excess tubing can be coiled and placed in the pouch on the back of the bag.

Open the zipper on both sides of the bag and place on a flat surface with viewing flaps on top.

Place the device on top of the open section of the bag.

Pull the front of the bag over the top of the device and feed both parts of one zipper together.

Close the zipper on the other side of the bag.

*smith&nephew RENASYS™ GO Negative Pressure Wound Therapy

Flaps on the top of the bag are for the privacy of the user. On the rear of the bag there is a belt loop should you wish to wear RENASYS GO around your waist.

Lifting the top flap allows access to the user interface. Lifting the bottom flap allows the canister to be viewed.

Belt Belt Loop Loop

Tubing TubingPouch Pouch

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