RENASYS GO Clinician User Manual REF 66801244 and 66801496

EN

Clinician User Manual

only Table of Contents Introduction

4

Lock or unlock for homecare use

14

Device description

4

Turn off device

14

Features and functions

4

Modes of operation

15

Clinician information – therapy time

15

Important information Monitoring NPWT

7

Clinician information – total time

16

Indications for use

7

Clinician information – battery charge

16

Contraindications

7

Battery power

17

Warnings

7

Safety alarms

19

Precautions

8

Troubleshooting Guide

23

Physician orders

9

Accessories

30

Glossary of symbols

10

Maintenance

32

Dressing changes

11

Device replaceable components

32

Canister selection

11

Storage

32

Installing canister

12

Returning device

32

Removing or changing canister

12

Electromagnetic compatibility (REF 66801244)

33

Electromagnetic compatibility (REF 66801496)

35

Connect RENASYS Soft Port dressing and canister

12

Disconnect RENASYS Soft Port dressing and canister

12

Specifications

37

Device start up

13

Caution statements

39

Software version

13

Essential performance

39

Language selection

13

LIMITED WARRANTY

40

Starting therapy

13

Global customer assistance

515

Pause/adjust therapy

14

Lock or unlock keypad

14

EN

Introduction

Device description

This user manual contains important information regarding the safe and effective operation of RENASYS™ GO (REF 66801244; REF 66801496) Negative Pressure Wound Therapy (NPWT) systems. These devices are intended for use by or on the direction of a trained and licensed physician. This manual is intended to aid in the training of personnel and to provide a reference for experienced users.

RENASYS GO devices are designed to provide NPWT to a closed environment over a wound, in order to evacutate exudates from the wound site to a disposable container, which may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials. The closed environment is created by applying a RENASYS sterile wound dressing to the wound site and connecting the sealed wound to the suction device. The wound dressing kit is considered to be the patient applied part.

The RENASYS GO Professional Healthcare Model (REF 66801244) is intended for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare provider.

The RENASYS GO runs on AC mains power with an AC power adaptor or internal battery power. The internal battery charges when the device is plugged into AC mains power both during operation and when turned off and not in use.

The RENASYS GO Home Healthcare Model (REF 66801496) is intended for use in both professional healthcare facilities and in residential settings, including nursing homes.

The RENASYS GO should be positioned no more than 19 inches or 50cm higher than the wound and face user's/ operator's location.

To ensure that the home healthcare device is safe for use in residential settings, this device is compliant with the IEC medical equipment and medical electrical safety standard 60601-1-11 for use of medical devices in the home healthcare environment. This standard includes the use of a double insulated Class II power supply and Class II power cord.

The RENASYS GO is a portable Negative Pressure Wound Therapy (NPWT) device. It is designed to be used with Smith & Nephew power supplies, Class I (REF 66800161) and Class II (REF 66801558). For proper and effective use of the RENASYS GO device, use only RENASYS GO canisters, RENASYS dressing kits and RENASYS ancillary componentry. Refer to instructions for use provided with dressing kits for addional information on dressing use and maintenance.

Features and functions User interface Status/alarm indicator Power button

Display screen

Battery status indicator Start/pause therapy and select

Up and down selectors

O-ring

Inlet port

4

Audio pause Keypad lock

EN

Canisters • 300ml and 750ml (300ml canister shown here)

Canister clips 300ml 200ml

Viewing window

100ml 50ml

Tethered connector caps Canister tube Quick click connector

! 50ml 100ml 200ml 300ml

5

EN

Proper use/correct orientation

Incorrect orientation

X X

*smith&nephew GO RENASYS™ Pressure Wound Negative Therapy

Negative Pressure Therapy

ephew *smith&n ™GO RENASYS

Wound

✓

Negative Therapy

*smith&nephew O RENASYS™G Pressure Wound

RENASYS™ GO device may also be used in a horizontal orientation, with device facing upward. Negative Therapy

ew *smith&nephS™GO RENASYPressure Wound

However, to maximize canister volume and optimize canister over-capacity alarm, upright device orientation is recommended. Caution: When device is operating in horizontal orientation, facing upward, alarm functionality may be compromised. Monitor wound dressing to ensure it is fully compressed and firm to the touch.

Power inlet and power supply

ephew *smith&n O RENASYS™G Pressure Wound Negative Therapy

AC mains power inlet

Power supply with DC cord

6

EN

Important information Monitoring NPWT

Contraindications Use of RENASYS GO is contraindicated in the presence of: • 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

Carefully monitor the patient, device, and dressing frequently to determine if there are any signs of bleeding, exudate accumulation (pooling), infection, maceration, or loss of Negative Pressure Wound Therapy (NPWT). The frequency should be determined by the clinician based on individual characteristics of the patient and wound. NPWT devices are not designed to detect or issue an alarm condition based on the presence of bleeding or pooling. These conditions may only be detected by frequent monitoring.

Warnings

Special attention to the risks of bleeding or loss of NPWT should be considered when prescribing for use in the Home Environment.

1.

NPWT may be impacted by various conditions related to system configuration, set-up and individual characteristics of the patient and wound (e.g. exudate characteristics, patient anatomy). Alignment of the port to the opening in the drape, use of a bridging technique and choice of dressing configuration based on wound characteristics may impact NPWT vacuum delivery over the course of therapy. Exudate volume, viscosity and consistency may influence fluid removal or occlusion formation. A full canister, incorrect canister orientation and device/tubing height relative to the wound can contribute to loss of NPWT and exudate accumulation within the wound, which could lead to maceration, infection, or unrecognized bleeding.

Carefully monitor patients for signs of bleeding, which may lead to interruption in therapy and hemodynamic instability. If such symptoms are observed, immediately discontinue therapy, take appropriate measures to control bleeding, and contact treating clinician.

2. Patients suffering from difficult hemostasis or who are receiving anticoagulant therapy have an increased risk of bleeding. During therapy, avoid using hemostatic products that, if disrupted, may increase the risk of bleeding. 3. Do not use directly 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.

Monitor the wound for infection and ensure that all wound filler is removed at each dressing change to reduce the risk of infection.

4. NPWT has not been studied on pediatric patients. Patient size and weight should be considered when prescribing the device.

Skin grafts should be closely monitored to ensure NPWT is being delivered.

5. Foam or gauze must not be tightly packed or forced into any wound area. Over-packing may interfere with distribution of NPWT evenly across the wound. This may decrease the ability of the wound to properly contract and permit exudate to remain in wound.

Review Contraindications, Warnings & Precautions before use.

Indications for use

6. In the event defibrillation is required, disconnect device from wound dressing prior to defibrillation. Remove wound dressing only if its location will interfere with defibrillation.

RENASYS™ GO is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy), as it may promote wound healing via removal of fluids, including irrigation and body fluids, wound exudates and infectious materials.

7.

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

Device is not MRI compatible. Do not bring device into MRI suite. Prior to entering MRI suite, disconnect device from dressing. Dressing can remain intact on patient.

8. Device is unsuitable for use in areas where there is danger of explosion (e.g., hyperbaric oxygen unit).

7

EN

9. When operating, transporting or disposing of device and accessories, there is risk of infectious liquids being aspirated or contamination of device assembly through incorrect use. Universal precautions should be observed whenever working with potentially contaminated components or equipment.

7.

8. When treating enteric fistulas, do not place NPWT dressing in direct contact with exposed bowel. Cover the wound bed, including fistula opening, with non-adherent gauze or with one layer of saline moistened gauze. During the course of treatment patient’s fluid levels must be closely monitored.

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

Precautions 1.

In the event a patient with spinal cord injury experiences autonomic dysreflexia, discontinue use of NPWT and immediately seek medical assistance.

9. Avoid use of circumferential dressings except in cases of oedema or heavily exuding extremities, where this technique may be necessary to maintain a seal. Consider using multiple drapes to minimize risk of decreased distal circulation. Regularly assess distal pulses, and discontinue therapy if changes in circulation are detected.

More frequent device and wound dressing monitoring, should be taken for patients who are or may be: • Suffering from infected blood vessels • Receiving anticoagulant therapy or platelet aggregation inhibitors, in addition to patients with intrinsic coagulation problems such as low platelet counts • Actively bleeding or have friable blood vessels or organs • Suffering from difficult wound hemostasis • Untreated for malnutrition • Noncompliant or combative • Suffering from wounds in close proximity to blood vessels or delicate fascia

10. Monitor patient for any signs of local or systemic infection. Infected wounds may require more frequent dressing changes. As NPWT is not intended to directly treat infection, if there are any signs of systemic infection or advancing infection at wound area, contact treating clinician immediately. 11. If multiple pieces of foam or gauze are needed to fill the wound profile, count and record how many pieces are present to ensure all pieces are removed at a dressing change to minimize the risk of retention and possible infection.

When monitoring patients for delivery of therapy, ensure wound dressing is free of air leaks, fully compressed and firm to the touch.

12. NPWT should remain on for duration of treatment. The length of time a patient may be disconnected from device is a clinical decision based on individual characteristics of patient and wound. Factors to consider include location of wound, volume of drainage, integrity of dressing seal, assessment of bacterial burden and patient’s risk of infection.

2. As a condition of use, device should only be used by qualified and authorized personnel. User must have necessary knowledge of the specific medical application for which NPWT is being used. 3. For patients with high risk of bleeding, use 300ml canister. Ensure the 300ml canister viewing is checked frequently for signs of bleeding.

13. Do not use a dressing kit with breached or damaged packaging. 14. Use of NPWT presents a risk of tissue in-growth. Tissue in-growth may be reduced by reducing therapy pressure, using a wound contact layer or increasing the frequency of dressing changes.

4. In the event of heavy or viscous drainage, drainage with sediment or when blood is present, regular monitoring and more frequent dressing changes may be required to reduce the risk of interruption of therapy, maceration, infection, and ensure proper exudate removal.

15. NPWT should not be painful. If patient reports discomfort, consider reducing pressure setting and use of a wound contact layer. Pressure setting is a clinical decision based on individual characteristics of patient and wound. Factors to consider include location of wound, volume of drainage and integrity of dressing seal.

5. Underlying structures, such as bone, tendons, ligaments and nerves should be covered with natural tissue or a non-adherent dressing layer prior to applying the NPWT dressing to ensure protection and minimize the risk of damage from direct contact with the dressing.

16. Maintain regular monitoring of device and wound site during therapy to ensure therapeutic treatment and patient comfort.

6. To minimize the risk of bradycardia, do not place NPWT in proximity to the vagus nerve. 8

EN

17. Device is only to be used with Smith & Nephew authorized components. Use of any other products have not been proven safe and effective with RENASYS™ GO device.

28. As with all adhesive products, apply and remove dressing carefully from sensitive or fragile skin to avoid blistering and skin stripping, especially after frequent dressing changes. Use of skin sealant may assist with protection of periwound skin.

18. Ensure canister tubing and RENASYS Soft Port are installed completely and without any kinks to avoid leaks or blockages in vacuum circuit. Position device and tubing appropriately to avoid risk of a trip hazard. Device and system tubing should be positioned no more than 19 inches or 50cm higher than the wound to ensure optimization of therapy and prevent therapy interruption.

29. If patient must be disconnected, the ends of the RENASYS Soft Port and canister tubing should be protected using tethered caps to avoid leakage of fluid and cross contamination. 30. When using RENASYS F/P or G/P wound dressing kits, ensure dressing clamp is engaged before switching off the device. For re-connection to device, ensure that device is active prior to opening the dressing clamp.

19. When bathing or showering patient must disconnect from device, protecting both ends of RENASYS Soft Port tubing using tethered caps. Ensure aeration disc located near quick click connector is free of moisture before reactivation of therapy to ensure proper alarm functionality and prevent interruption in therapy.

Physician orders 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 wound and patient to ensure clinical indications for Negative Pressure Wound Therapy (NPWT) are met.

20. If any liquids penetrate device, discontinue use and return to your Smith & Nephew authorized provider for service. 21. CT scans and x-ray have the potential to interfere with some electronic medical devices. Keep device out of x-ray or scanner range.

All orders should include: • Wound location, size and type • Smith & Nephew wound dressing kit • Pressure settings • Frequency of dressing changes • Adjunctive dressings

22. Use caution if device is used in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. 23. AC mains power can only be removed by disconnecting power cord or AC power adaptor. Take care in positioning the device to allow access to cord receptacle. 24. If power cord is damaged, wires are frayed or exposed, do not use power cord. Contact your Smith & Nephew representative for a replacement cord. 25. Canisters should be changed at least once a week, whenever there is a change in patient or in the event that canister contents reach maximum volume indication (300ml or 750ml fill line). Do not wait for the canister over-capacity alarm to activate to change canister. 26. Canisters kits are single use devices. Do not reuse. 27. Do not apply SECURA™ No-sting barrier film wipes directly to open wounds. SECURA No-sting barrier film is flammable. Use in a well ventilated area. Avoid using around flames and sources of ignition Keep out of reach of children. For external use only.

9

EN

Glossary of symbols Power Turns device ON and OFF.

Keypad lock Locks keypad to restrict accidental adjustment of therapy. When lock is activated the light will illuminate solid blue.

Battery status indicator Shows status of battery life.

Audio pause Pauses alarm for approximately 2-3 minutes. When activated the light will illuminate solid yellow.

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

If a new alarm occurs, the audio pause will cancel.

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

Keep dry

Authorized European representative

Storage temperature

Batch code

Date of manufacture

Serial number

Manufacturer

Product catalogue number

Patient number

CE mark

Do not use if package is damaged

Patient

Keep upright

Biological risk

Direct current

Non-ionizing electromagnetic Radiation

Equipment classification Isolation type BF applied part

ETL listing mark EU:

Not for general waste

Refer to instruction manual/booklet Caution:

Follow operating instructions

Single use

Class II equipment

Do not reuse

IP22

Start/pause therapy and select Starts or pauses therapy. It is also used to confirm settings within therapy.

Enclosure protected against ingress of small objects and dripping water

MR

MR unsafe

Keep away from magnetic resonance imaging (MRI) equipment

10

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician

EN

Dressing changes

Canister selection

Refer to instructions for use provided with dressing kits for additional information on dressing use and maintenance.

Device is to be used with RENASYS™ GO 300ml or 750ml canisters.

1.

RENASYS GO canisters use an integral two stage bacterial filter for protection of device against overflow and spread of aspirated micro-organisms.

Foam dressings should be changed every 48 to 72 hours after the initial application of therapy. If no leak is present and the patient is comfortable, subsequent dressing changes should occur no less than 3 times per week.

Canisters are designed for single patient use. Do not re-use. Canisters are provided non-sterile and should not be used in a sterile field.

2. Gauze dressings should be changed 48 hours after the initial application of therapy. If no leak is present and the patient is comfortable, subsequent dressing changes should occur 2–3 times per week.

Canisters should be changed at least once a week, whenever there is a change in patient or in the event the canister contents reach maximum volume indication (300ml or 750ml fill line). Do not wait for alarm activation to change canister.

3. In the event of heavy or viscous drainage, drainage with sediment or when blood is present, regular monitoring and more frequent dressing changes may be required.

Canisters may have to be changed regularly within single-patient treatment episodes if exudate levels are high. Check canisters regularly to monitor exudate levels, ensuring they are below maximum volume indication (300ml or 750ml fill line).

4. When dressing a wound involving a difficult to seal anatomy or exposure to external moisture, frequent inspection of dressing is recommended to ensure a seal is maintained. Ensure wound dressing is fully compressed and firm to the touch.

Check canister for any signs of cracks or damage. If noted, discard and replace canister. Ensure canister viewing window is checked frequently for signs of bleeding.

5. Ensure all wound filler material placed in the wound has been removed before redressing the wound. If foam dressing adheres to the wound, apply 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.

For patients with high risk of bleeding, use 300ml canister.

6. As with all adhesive products, apply and remove dressing carefully from sensitive or fragile skin to avoid skin stripping, especially after frequent dressing changes. Use of skin sealant may assist with protection of periwound skin. 7.

Monitor patient for any signs of local or systemic infection by checking dressing frequently. Infected wounds may require more frequent dressing changes. As NPWT is not intended to directly treat infection, if there are any signs of systemic infection or advancing infection at wound area, contact treating clinician immediately.

11

EN

Installing canister 1.

Connect RENASYS™ Soft Port dressing and canister

Ensure device is off.

Connect Soft Port to canister tubing by pushing orange quick click connectors together. An audible click indicates connection is secure.

2. Remove paper tape around canister tubing to release tubing to full length. 3. Open both orange clips on sides of canister. 4. Align canister so that viewing window is facing forward. 5. Push canister gently over device inlet port. 6. Engage both canister clips. Clips will click when properly engaged. 7.

Following canister installation, to verify functional complete blockage alarm, turn device on and insert tethered cap of canister tubing into connector to simulate a blockage. A functional device will activate a complete blockage alarm within 5 minutes. In the case that complete blockage alarm does not activate, check canister installation and contact your Smith & Nephew authorized representative.

*smith&nephew RENASYS™ GO Negative Pressure Wound Therapy

*smith&nephew RENASYS™ GO Negative Pressure Wound Therapy

*smith&nephew RENASYS™ GO Negative Pressure Wound Therapy

Note: Do not cover aeration disc.

Disconnect RENASYS Soft Port dressing and canister

*smith&nephew RENASYS™ GO Negative Pressure Wound Therapy

1. 300ml 300ml 300ml 200ml 100ml

200ml 100ml

200ml 100ml 50ml

Hold orange quick click connector above wound to help ensure exudate does not leak from tubing.

50ml

50ml

2. Turn device off. 3. Disconnect canister tubing from Soft Port.

Removing or changing canister 1.

Hold orange quick click connector above wound to help ensure exudate does not leak from tubing.

2. Turn device off. 3. Disconnect canister tubing from Soft Port. 4. Insert tethered cap into both sides of orange quick click connector. 5. Release orange canister clips on sides of canister and gently pull away from device. 4. Insert tethered cap into both sides of orange quick click connector.

Disposal of used canisters should follow facility protocols or local ordinances relating to handling of potentially infected or biohazardous materials.

12

EN

Device start up

Language selection

Device operates on both battery and AC mains power.

To change language selection:

If battery operation is required for first use of device, battery must be charged from AC mains power until battery status top indicator light illuminates solid green. During charging process the battery status top indicator light will flash green.

1.

2. Simultaneously press and hold Up

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

Up

4. Pressing Select

buttons for 2

buttons to scroll to desired button.

button at this point will power

on the device at a preset 80mmHg in continuous mode, if the device is being used for the first time, or the previously entered pressure setting.

If device is being used for the first time, the user will be given the option to select desired language:

Starting therapy

►E n g l i s h D a n s k

1.

Select prescribed pressure setting using Up

Software version

and Down

2. Press Select

To access software version of a device:

buttons.

button to start therapy.

C o n t i n u o u s ► 1 0 0 mmH g

Turn device off.

3. Finished dressings should be fully compressed,

button for 2 seconds.

Device display will show: W e l c o m e S t a r t i n g

and Down

language, followed by Select

V X . X X

2. Press and hold Power

+ Power

3. Language can now be selected using

button

S t a n d b y ► 1 0 0 mmH g

1.

+ Select

seconds.

If AC mains power is required, connect power supply to the AC mains power inlet, on the side of device. To activate device, press and hold Power for 2 seconds. Device display will show:

Turn device off.

firm to the touch and leak free. Setting pressure level is a decision that the healthcare provider must make based on an individual assessment of the particular wound.

V X . X X

3. The software version is provided on the lower right-

40–120mmHg is recommended therapeutic pressure range.

hand corner of the welcome display screen.

In the event you have a wound that is difficult to seal, you may increase the pressure setting to achieve desired negative pressure at the wound bed. Device will show set pressure level. If device detects operation outside of the set pressure, it will result in alarm activation. Caution: Before starting therapy, ensure that device and system tubing are located no more than 19 inches or 50cm higher than the wound and is away from any direct sources of heat.

13

EN

Pause/adjust therapy

Lock or unlock for homecare use (Feature available only on RENASYS™ GO: REF 66801496)

Therapy may be paused by pressing show a standby message on display screen and

The user interface may be locked for homecare use to prevent inadvertent changes to the therapy settings by unauthorized users in a homecare environment.

pressure setting can be changed using Up

To lock for homecare use:

Select

Down

button once. When paused, device will and

buttons.

1.

S t a n d b y ► 1 0 0 mmH g

Press Select

Note: Therapy must be started for homecare lock to function.

button to restart therapy.

2. Simultaneously press and hold the Keypad Lock + Audio Pause

Lock or unlock keypad button for 2 seconds. When

K e y p a d L o c k e d ► 1 0 0 mmH g * * *

activated, the light will illuminate solid blue.

When device is locked for homecare use, the therapy settings cannot be changed. The Power and Audio pause buttons are the only active buttons. The device may be powered off to temporarily stop therapy. When powered back on, the device will remain locked for homecare use and will resume therapy using the previously entered settings.

K e y p a d L o c k e d ► 1 0 0 mmH g

If keypad on user interface has not been used for 15 minutes, keypad will automatically lock. In active mode, if keypad on user interface has not been used for 15 minutes, keypad will automatically lock. The light above keypad lock button will illuminate solid blue.

When device is locked for homecare use, screens displaying prescribed pressure setting will include 3 asterisks.

To unlock user interface, press and hold Keypad Lock

buttons for 5 seconds.

The solid light above the keypad lock button will illuminate solid blue.

To lock user interface when device is active, press and hold Keypad Lock

Select prescribed therapy mode and pressure setting and start therapy.

To unlock the device from homecare use:

button for 2 seconds.

Simultaneously press and hold the Keypad Lock + Audio Pause

K e y p a d A c t i v e ► 1 0 0 mmH g

buttons for 5 seconds.

K e y p a d A c t i v e ► 1 0 0 mmH g

Note: Locking keypad only locks row of keys under display screen - Power Button is not locked.

Note: When set for homecare use and powered on, the device will display one of the following depending on operating mode selected: C o n t i n u o u s ► 1 0 0 mmH g * * * I n t e r m i t t e n t ► 1 0 0 mmH g * * *

Turn off device Press and hold Power power off device. 14

button for 2 seconds to

EN

Modes of operation

Clinician information - therapy time

RENASYS™ GO offers both continuous and intermittent modes. Selection of therapy mode setting is a clinical decision based on physician judgment, wound type, exudate level, exudate consistency and patient comfort.

Device displays information which allows clinicians to see therapy time (total hours and minutes of continuous or intermittent therapy) delivered to the patient. To access therapy time:

In continuous mode, device will maintain selected pressure setting without stopping until switched off.

1.

Turn device off.

2. Simultaneously press and hold

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

Down

+ Select

+ Power

buttons for

2 seconds.

Intermittent therapy is not recommended for:

3. Use Down

button to scroll to "show time"

•

Highly exudating wounds

•

Wounds with tunnels or undermining

option. Press Select

•

Wounds in difficult areas where maintaining a seal is problematic

display screen:

•

Patients who experience pain during intermittent therapy

A c t i v e T i m e x x x x x H , x x

to show the following

m

To change therapy between continuous and intermittent mode:

4. Therapy time display will show for 5 seconds and

1.

To reset therapy time:

then return to main menu.

Turn device off.

2. Simultaneously press and hold Down

+ Select

+ Power

1. buttons for

button to scroll to "clear time"

option. Press Select

2 seconds. 3. Use Up

Use Down

button to show the

following display screen: or Down

buttons to scroll

C l e a r ►T i m e ?

between continuous and intermittent mode. Press the Select

A c t i v e

button to confirm. 2. Press Select

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

button again to confirm that you

want to clear active time. 3. Use Down Press Select

button to scroll to "yes" option. button to show the following

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

4. Display will show for 5 seconds and then return to main menu. Active time should be cleared between patients. This will allow the clinician to monitor patient therapy compliance.

15

EN

Clinician information - total time Device displays total number of hours accumulated in active mode. This time cannot be reset. To access total time display screen: 1.

Turn device off.

2. Simultaneously press and hold Down

+ Select

+ Power

buttons for

2 seconds. 3. Use Down

button to scroll to "total time"

option. Press Select

to show the following

display screen: T o t a l x x x x x

T i m e H

4. Display will show for 5 seconds and then return to main menu.

Clinician information - battery charge Device displays percentage of battery charge remaining. To access battery charge display screen: 1.

Turn device off.

2. Simultaneously press and hold Down

+ Select

+ Power

buttons for

2 seconds. 3. Use Down

button to scroll to "battery charge"

option. Press Select

to show the following

display screen: B a t t e r y x x x %

4. Press Select

C h a r g e

button to return to the main

menu.

16

EN

Battery power Device can be used on battery power to provide the user greater mobility. A fully charged battery can last up to 20 hours, dependent on pressure setting. During therapy, if battery level is low, the device can be plugged into AC mains power without interrupting therapy. Battery will recharge while therapy continues to be delivered. Battery status indication RENASYS™ GO contains a lithium ion rechargeable battery. There are several battery level indicators on this device: Indicator B a t t e r y F u l l ► 1 0 0 mmH g B a t t e r y F u l l ► 1 0 0 mmH g * * *

Battery level

Action

Battery is fully charged and has up to 20 hours active therapy remaining. Battery status top indicator will illuminate solid green.

No action required.

Battery has up to 10 hours active therapy remaining. Battery status top indicator will flash green.

No action required.

Battery has up to 6 hours active therapy remaining. Battery status top indicator will flash green and battery status bottom indicator will illuminate solid yellow.

No action required.

Battery has up to 3 hours active therapy remaining. Battery status bottom indicator will illuminate solid yellow. Low battery alarm state (see alarm section).

Audio alarm can be paused by pressing the Audio pause button on user interface. Plug device into AC mains power to charge battery.

Battery has up to 1 hour active therapy remaining. Battery status bottom indicator will illuminate solid yellow. Low battery alarm state (see alarm section).

Device should be plugged into AC mains power to charge battery and ensure continued delivery of therapy.

Battery has only 2 minutes of active therapy remaining. Battery status bottom indicator will illuminate solid yellow. Low battery alarm state (see alarm section).

Device should be plugged into the AC mains power or therapy will discontinue.

Display screen when device is locked for homecare use. Homecare lock feature is available only on the RENASYS GO: REF 66801496

! !

! !

! !

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

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

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

17

EN

Indicator

Battery level

Action

! !

After 2 minutes in an extremely low battery charge state, device will power off.

Plug device into AC mains power.

When plugged into AC mains power, display screen will show “Charging” message and battery status top indicator will flash green.

No action required. Device may take up to 3 hours to charge.

If battery unit within device has failed to charge, display screen will show "Battery Failed" message and battery status bottom indicator will illuminate solid yellow.

Therapy will only be delivered if plugged into AC mains power. Device will not operate on battery power.

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 ►1 0 0

mmH g

C h a r g i n g ►1 0 0 mmH g * * *

Display screen when device is locked for homecare use. Homecare lock feature is available only on the RENASYS™ GO: REF 66801496

! B A T T E R Y F A I L E D ►1 0 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 mains power.

Display screen when device is locked for homecare use. Homecare lock feature is available only on the RENASYS GO: REF 66801496 Caution: Keep device away from direct heat sources during charging.

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Contact your Smith & Nephew authorized representative.

EN

Safety alarms General All alarms for RENASYS™ GO are determined to be "Low Priority," indicating that operator awareness is required (IEC 60601-1:2005, 3rd edition and IEC 60601-1-8:2006). In an alarm state with the audio paused, if a different alarm state occurs, the audio pause will be canceled, the audio will sound and the display screen will indicate the new alarm state. When multiple alarm states are present, the device's display screen will alternate between the display information for each alarm activated. Cautions – Lack of alarms: RENASYS GO device is equipped with high flow/leak, low vacuum and complete blockage/canister over-capacity alarms to alert users to these events occurring during therapy. These alarms are designed to activate based on changes in pressure status detected by device. However, there are scenarios that may occur during therapy that can impact alarm functionality. Therefore, it is important that patient, device and wound dressing are monitored at an appropriate interval to ensure therapy is being delivered. Over vacuum alarm: The system has encountered an excessively high vacuum (of >235mmHg) and device will stop delivering therapy. Event must be investigated by healthcare provider immediately and corrected. Alarm state Over vacuum

Visual indication Status/alarm indicator: illuminates solid yellow

Display screen ! THERAPY STOP ! OVER VACUUM

Audible alarm Beeps 2 times every 20 seconds Audio cannot be paused

High flow/leak alarm: Device detects a significant leak in the system. Once corrected, alarm will automatically reset and status/alarm indicator will return to solid green. Alarm state

Visual indication

Display screen

High flow/leak

Status/alarm indicator: illuminates solid yellow

! WARNING ! LEAK

High flow/leak Audio paused

Status/alarm indicator: illuminates solid yellow

! AUDIO PAUSED ! LEAK

Audible alarm Beeps 2 times every 20 seconds Audio may be paused Paused for 2–3 minutes

Low vacuum alarm: Vacuum level is lower than set point of NPWT by >15mmHg. Once corrected, alarm will automatically reset and status/alarm indicator will return to solid green. Alarm state

Visual indication

Display screen

Low vacuum

Status/alarm indicator: illuminates solid yellow

! WARNING ! LOW VACUUM

Low vacuum Audio paused

Status/alarm indicator: illuminates solid yellow

! AUDIO PAUSED ! LOW VACUUM

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Audible alarm Beeps 2 times every 20 seconds Audio may be paused Paused for 2–3 minutes

EN

High vacuum alarm: Vacuum level is higher than set point of NPWT by >15mmHg and device will stop delivering therapy. Event must be investigated by healthcare provider immediately and corrected. Alarm state High vacuum

Visual indication Status/alarm indicator: illuminates solid yellow

Display screen ! THERAPY STOP ! HIGH VACUUM

Audible alarm Beeps 2 times every 20 seconds Audio cannot be paused

Complete blockage/canister over-capacity alarm: The system detects a complete blockage in the system, this includes a canister where contents have reached maximum volume capacity. There will be no negative pressure at the wound site. Once corrected, alarm will automatically reset and status/alarm indicator will return to solid green. Alarm state

Visual indication

Display screen

Complete blockage/canister over-capacity

Status/alarm indicator: illuminates solid yellow

! WARNING ! BLOCKAGE / FULL

Complete blockage/canister over-capacity Audio paused

Status/alarm indicator: illuminates solid yellow

! AUDIO PAUSED ! BLOCKAGE / FULL

Audible alarm Beeps 2 times every 20 seconds Audio may be paused Paused for 2–3 minutes

Cautions – Complete blockage/canister over-capacity alarm: Complete blockage/canister over-capacity alarm activation is driven by occlusion of filter located at top of canister. As canister fills with fluid, the filter will begin to occlude as fluid makes continuous contact, creating a complete blockage in vacuum circuit. A completely occluded filter will result in canister over-capacity alarm activation. Complete blockage/canister over-capacity alarm will not activate until filter is completely occluded. Canister orientation, rate at which fluid enters canister and how exudate solidifies can impact filter occlusion and canister over-capacity alarm functionality. Canisters should be kept in an upright orientation to optimize canister over-capacity alarm functionality while maximizing canister volume. When canister is operating in horizontal orientation, facing upward, alarm functionality may be compromised. Refer to information on canister orientation on page 6. To optimize canister over-capacity alarm functionality, canister must be changed in the event the canister contents reach maximum volume indication (300ml or 750ml fill line). Do not wait for alarm activation to change the canister. Note: For RENASYS F/P or G/P wound dressing kits, the complete blockage alarm will only activate if a complete blockage occurs with the canister tubing. There is no blockage detection in the dressing tubing.

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EN

Low battery alarm: The system is operating on battery power and has detected depletion of available battery energy. If the power adaptor is plugged into AC mains power and connected to the device, the alarm will automatically reset. Alarm state

Visual indication

Display screen

1. Status/alarm indicator: illuminates solid yellow 2. Battery status bottom indicator: illuminates solid yellow

! Attention ! Low Battery

Low battery (Very low)

1. Status/alarm indicator: illuminates solid yellow 2. Battery status bottom indicator: illuminates solid yellow

! RECHARGE ! V. Low Battery

Low battery (Extremely low)

1. Status/alarm indicator: illuminates solid yellow 2. Battery status bottom indicator: illuminates solid yellow

! RECHARGE ! Ex. Low Battery

Low battery audio paused

1. Status/alarm indicator: illuminates solid yellow 2. Battery status bottom indicator: illuminates solid yellow

! AUDIO PAUSED ! Low Battery

Low battery

Audible alarm Beeps 2 times every 20 seconds Audio may be paused Beeps 2 times every 20 seconds Audio may be paused Beeps 2 times every 20 seconds Audio may be paused

Paused for 2–3 minutes

Battery failed alarm: The system has detected a failure of the battery in the device. Therapy can only be continued by keeping the device plugged into AC mains power. Alarm state

Battery failed

Visual indication 1. Status/alarm indicator: illuminates solid yellow 2. Battery status bottom indicator: illuminates solid yellow

Display screen

Audible alarm

! BATTERY FAILED l100 mmHg ! BATTERY FAILED l100 mmHg *** (shown when locked for homecare use)

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None