WoundASSIST TNP System User Manual

Contents Introduction... 1 About this Manual... 1 About the WoundASSIST TNP System... 1 Console... 1 Battery Charger... 3 Wound Pack... 4 Canister... 4 Console Mounting Accessories... 5 Carry Bag... 6 Clinical Applications... 7 Indications... 7 Contraindications... 7 Cautions... 7 Considerations... 8 Therapy Modes... 8 Monitoring the Wound... 9 Controls, Indicators and Alarms... LCD Screen... Console Control and Indicator... Power/Alarm Indicator... Console Screen Buttons and Icons... Run Mode... Care Options... Setup Screen... To Lock The Screen... Warnings and Alarms... Information Indicators... Help Screens...

10 10 10 10 11 12 12 13 13 13 14 14

System Setup... Preparing the System... Installing the Canister... Setting up the Console... Applying the Wound Pack...

15 15 16 16 18

Operation... 21 Starting Therapy... 21 Wound Pack Change... 22 Canister Change... 23 Disconnecting from the Console... 24 Cleaning Procedure... 25 Routine Maintenance... 27 General... 27 Serial Number... 27 Troubleshooting and Warning/Alarm Conditions... 28

(i)

Technical Description... 32 Console... 32 Battery Charger... 33 Canister... 34 Wound Packs... 34

(ii)

General Safety Before you start operating the system, read carefully all the instructions in this user manual. The system has been designed to comply with regulatory safety standards including EN 60601-1:1990/A13:1996. Safety Warnings • Electrical equipment may be hazardous if misused. The Console's rear case should only be removed by authorised technical personnel. • Do not use the Console in the presence of flammable gases such as anaesthetic agents. Precautions For your safety, always take the following precautions: • Regularly check the system when in use, for Console operation, battery status, Wound Pack integrity and type/amount of exudate. • Keep the Console away from sources of liquids and do not immerse in water. • Do not expose the system, especially the Wound Pack, to naked flames or other sources of ignition, such as cigarettes, etc. • Do not store the system in direct sunlight. • Disconnect the battery charger connector from the Console before cleaning and inspecting. • Do not use phenol-based solutions to clean the system. • Make sure the system is clean and dry prior to storage. • Only the Console, canister and Wound Pack combinations as indicated by Huntleigh Healthcare should be used. The correct function of the product cannot be guaranteed if incorrect Console, canister and Wound Pack combinations are used. • In order to ensure continued compliance with IEC/EN/UL 60601-1, only the WoundASSIST TNP Battery Charger is to be used with the Console.

Caution Electromagnetic compatibility (EMC). This product complies with the requirements of applicable EMC Standards. The use of accessories not specified by the manufacturer may result in increased emissions by, or decreased immunity of, the equipment, affecting its performance.

(iii)

1. Introduction About this Manual

This is your introduction to the WoundASSIST ® TNP Wound Therapy System. Use it to initially set up the system, and keep it as a reference for day-to-day use and as a guide to maintenance.

About the WoundASSIST TNP System

WoundASSIST TNP provides a non-pharmacological,

Console

physical method of promoting wound healing and works by the local application of sub-atmospheric pressure (suction) across a wound. WoundASSIST TNP delivers negative pressure wound therapy easily and effectively in both the hospital and community settings without compromise in performance. The WoundASSIST TNP system comprises: • A Console which provides the suction. • A disposable Canister on the side of the Console to collect the exudate. • A sterile Wound Pack. The WoundASSIST TNP Console is designed to work in both the vertical (LCD screen at the top) and horizontal (with the front face uppermost) orientations.  The Console is not designed to operate in the horizontal orientation with the front face on the underside, or tilted at an angle to the vertical. The LCD screen has a resistive touch-screen that can be operated whilst wearing gloves.

 Horizontal with Front Face Uppermost

Vertical



Tilted

Horizontal with Front Face on Underside

1

WoundASSIST TNP Console Carry Handle

LCD Screen Power / Alarm Indicator

On / Off Button Connector for Battery Charger Retaining Clip for Canister

Graduations for Vertical and Horizontal Orientations Connector for Wound-Drainage Tube Canister

WoundASSIST TNP Console (Rear View)

Non-Slip Feet Carry Handle

Replaceable Odour Filter and Filter Housing

Console Accessory Mounting Slots

Canister

2

The LCD screen on the Console automatically rotates through 180° when the Console is moved between the vertical and horizontal orientations. There are two sets of graduations on the side of the Canister which show the volume of exudate collected in both the vertical and horizontal orientations of the Console. Battery Charger

The Console is not connected directly to the mains/ power supply; instead, the Console operates from power provided by an internal rechargeable battery. An icon on the LCD screen indicates the battery charge status, and when it needs to be recharged. The WoundASSIST TNP battery charger includes three adapters to enable it to be plugged into different mains/ power sockets around the world; select the connector for your mains/power socket and push it firmly onto the end of the battery charger until it clicks into position. To recharge the internal battery in the Console: • Plug the cable connector on the battery charger into the connector on the side of the Console. • Plug the battery charger into the mains/power socket.  The Console will continue to operate normally while the battery charger is connected.  Even if there is a battery fault, the Console can still be operated directly from the battery charger.

Caution Huntleigh Healthcare will not be responsible for any problems or damage caused to the Console if a user connects any power source other than the WoundASSIST TNP battery charger.

Mains/Power Adapters

To Console

WoundASSIST TNP Battery Charger

3

Wound Pack

There are three sizes of Wound Pack, which are defined by the size and quantity of the semi-permeable transparent film in each dressing pack: • Small/Medium, where the film dressing has 2 off 15 cm x 20 cm. • Medium/Large, where the film dressing has 2 off 20 cm x 30 cm. • Extra Large, where the film dressing has 3 off 20 cm x 30 cm

Canister

The semi-opaque plastic Canister is fitted to the side of the Console, and excess wound fluid is drawn into the sealed Canister for subsequent disposal; a two-part drainage tube connects the wound drain to the Canister inlet. The Canister incorporates a 1.2 micron bio-filter designed to remove potentially harmful organisms (which may originate in the wound) from the air expelled to the environment. The Canister has an integral plug which is inserted into the Canister inlet prior to disposal; this reduces the possibility of accidental spillage. The Canister can hold up to 500 ml of fluid when vertical, and up to 400 ml when horizontal. The Canister is single use only.

Canister Outlet (to Console)

4

Canister Inlet (from Wound)

Console Mounting Accessories

Console with Bed Hook

The following mounting accessories are supplied with the Console: • Bed Hook. • DIN Rail Clamp. • IV Pole Clamp. They are installed onto the Console by pushing the two mounting clips on the hook/clamp into the square slots in the rear case of the Console below the filter housing.

Console with IV Pole Clamp

5

Console with DIN Rail Clamp

Carry Bag

As the Console is battery-operated, it is completely portable and enables uninterrupted therapy in all care settings. The Console can be fitted into a carry bag, which has straps to enable the Console to be carried or worn by the patient (e.g. over the shoulder) or fitted to a wheelchair, providing the patient with extra mobility.

Console Carry Bag

Canister Inlet

Mounting Strap

6

2. Clinical Applications Indications

Contraindications

To manage exudate and promote healing within a range of chronic, sub-acute and acute wounds by the application of topical negative pressure. TNP™ wound therapy should NOT be used in the

following circumstances: • Wounds where there is malignancy in the wound bed or margin (the only exception is end-of-life palliative care). • Open exposed joints and untreated osteomyelitis. • Open peritoneal spaces, pleural cavity or unexplored fistulas. • Exposed organs, arteries or veins. • Wounds covered with necrotic tissue, eschar or more than 30% slough. Cautions

TNP wound therapy should be used with care in patients

with the following symptoms or conditions: • Patients with coagulopathies, on anticoagulant therapy, with active bleeding or difficult haemostasis in the wound bed. • Patients with unstable structures, e.g. bone fragments, beneath the wound which may be adversely affected by the application of therapy. • Wounds that are clinically infected need close supervision including Wound Pack changes every 12 to 24 hours. Discontinue therapy and seek medical advice where systemic infection may be linked to the wound. • Patients with known hypersensitivities or allergies to any of the components used in the Wound Pack, Console or Canister. • Therapy may rarely trigger muscle spasm or autonomic dysreflexia in patients with neuromuscular disorders or spinal cord injury: stop therapy to remove stimulus. • Patients with ischaemic wounds require close supervision to ensure blood supply to the wound bed is adequate. • Never apply a WoundASSIST TNP Wound Pack without being certain that all previous dressing materials have been removed.

7

Considerations

WoundASSIST TNP therapy may be unsuitable to

patients who are unable or unwilling to adhere to the therapy or those who will require repeated interruptions in therapy for extended periods each day. Clinicians will also need to consider whether the patient (and their wound) is suitable for management outside of a supervised setting e.g. Are they able to manage their own Console and Wound Pack? Do they know when and how to alert the clinician should they need assistance? The decision to commence/terminate TNP wound therapy, plus the continual assessment of the wound and patient, must be supervised by a skilled clinician who is competent in the techniques relevant to this system. Therapy Modes

The Console can be set to supply either Continuous or Intermittent TNP wound therapy, as follows:

Continuous Therapy

This should be selected for: • High exudate wounds, particularly during the initial therapy. • First stage of treatment when granulation tissue is sparse. • Wounds that could cause pain on intermittent negative pressure settings e.g. vascular ulcers. • Wounds that are in locations that are difficult to dress or create a seal e.g. peri-rectal area, fingers or toes. • Wounds that are located adjacent to, or on top of, unstable body structures (e.g. unstable chest wall or non-intact fascia) to minimise movement and stabilise the wound bed.

Intermittent Therapy

This should be selected for: • Wounds that have less exudate as they heal. • Wounds that are clean and healthy, with granulation tissue and/or epithelialisation at the wound margin.

Treatment Time

WoundASSIST therapy will give optimum performance

when applied without interruption.  Occasionally the therapy may need to be interrupted (e.g. for an MRI scan); if the therapy is stopped for more than one to two hours, apply a conventional exudate-management dressing until a new WoundASSIST TNP Wound Pack can be applied.

8

Monitoring the Wound

The treating clinician is responsible for detailed observation of the wound and making a physician referral where necessary:

Observation

This should include, but is not limited to: • Wound Pack status (air/fluid leak). • Console settings. • Wound condition. • Wound progress. • Type and amount of exudate. • Patient comfort. • Condition of surrounding tissue (e.g. maceration, redness, heat, oedema). • Local and systemic signs of infection.

Frequency

• At least once per shift for acute care. • At every visit in home care; patients must be given advice as to when and how to contact their clinician between visits.

9

3. Controls, Indicators and Alarms LCD Screen

The LCD screen shown below is the standard default screen that is displayed when the Console is in the Standby mode.  There will be an audible “beep” when any button on the screen, or the On/Off button, is pressed. Power / Alarm Indicator

Menu Bar

On / Off Button

LCD Screen

Status Bar

Console Control and Indicator

The top panel of the Console has an On/Off button and Power/Alarm indicator. Press the green On/Off button to power up the Console. To switch off the Console, press the On/Off button and keep it depressed for approximately 4 seconds until the Power/Alarm indicator is extinguished, and then release.

Power/Alarm Indicator

The Power/Alarm indicator is a tri-colour LED. The LED will display one of the following conditions when the Console is in operation:

LED Status Green (Flashing) Green (Constant) Yellow (Constant) Red (Flashing)

Description 1. The Console is running the power-up self-test. 2. The Console is being initialised when the battery charger is first connected. The Console is active, and is not being recharged.

The Console is being recharged.

Alarm condition.

10

Console Screen Buttons and Icons The table below details the buttons and icons on the screen in Run or Standby mode: Button/ Icon

Description

Press the green Start button to start the therapy.

Press the red Stop button to stop the therapy. Press the Care Options button to go to the Care Options screen, where the therapy settings (comprising Continuous/Intermittent therapy, Intensity and Negative Pressure settings) can be changed. Press the Setup button to go to the Setup screen, where the Language, Service and Intermittent therapy settings can be changed. Press the Help button to go to a context-related Help screen, which gives hints and tips relating to the specific buttons and icons on the original screen. The Warning symbol alternates with the Help symbol when a warning condition has been detected. The Battery icon indicates the relative state of charge in the internal battery (for both charging and discharging). The Lightning Strike icon indicates that the battery charger is connected to the Console. The Chevron icon indicates that the Console is in Run mode. The Chevron icon will scroll from 1-5 whilst the Console is in Run mode. The Therapy icon on the status bar indicates which of the following two timed therapies is being applied: • Continuous therapy mode (Cont icon). Default setting. Refer to “Therapy Mode” on page 12. • Intermittent therapy mode (Int icon). Refer to “Therapy Mode” on page 12. The therapy settings can be changed on the Care Options screen. The Intensity icon on the status bar indicates the therapy intensity currently set. Refer to “Therapy Intensity” on page 12. The Intensity settings can be changed on the Care Options screen. The Negative Pressure icon on the status bar indicates the level of negative pressure being applied at the wound bed. Refer to “Therapy Pressure” on page 12. The Negative Pressure is changed on the Care Options screen.

11

Run Mode

This screen is the standard default screen that is displayed when the Console is in the Run mode.

Care Options

Press the Care Options button to change the therapy mode, therapy intensity or therapy pressure.

Therapy Mode

The Console has two therapy modes: • Continuous - This allows the Console to apply a predefined negative pressure constantly over a given time period. This is the default setting. • Intermittent - This allows the therapy to be applied for a pre-defined negative pressure over a predefined time and to then stop the negative pressure for a pre-defined time before restarting automatically. The default Intermittent settings are 5m (minutes) ON and 2m OFF. Press the button next to the therapy mode to select the therapy required.

Therapy Intensity

The Intensity function relates to how quickly the Console gets to the target pressure when starting the therapy cycle. The Console has three Intensity settings: • Minimum (Min icon). • Medium (Med icon). This is the default setting. • Maximum (Max icon). Press the button next to the Intensity icon to scroll through the three settings.

Therapy Pressure

The Negative Pressure setting can be adjusted from -25 mmHg to -200 mmHg, in increments of -25 mmHg, with a default setting of -75 mmHg. • Suction can be increased to -100 mmHg or -125 mmHg in the event of high exudate. • Suction can be decreased to -50 mmHg or -25 mmHg if the patient reports pain in the wound.

12

 It is recommended that any pain is controlled first, and then the negative pressure is increased to the optimum pressure when it can be tolerated. Confirm Changes

When all settings are adjusted correctly, press the Accept button to confirm the changes.

Setup Screen

The setup screen allows the user to change the Intermittent Setup, the Language, and view Service information for the Console.

Intermittent Setup

Press the Intermittent Setup button to change the intermittent therapy settings. Intermittent therapy can be set to run at a defined negative pressure for a specified time and to then pause for a specified time e.g. 5m (minutes) ON and 2m OFF. To change the intermittent time settings, press the button and the number to the right will change in one minute increments.  The minutes increment to a maximum of 10, and then go back to 1. Press the Accept button to confirm the changes.

Language Settings

To change the language press the Language button. Press the left and right arrow buttons to scroll through the available languages. Press the Accept button to confirm language selection.

Service Functionality

The Service button allows the user to view Console data such as the current software version, alarm occurrences, LCD screen brightness, therapy run time, Console time and date, and battery usage data. A Contacts button is also provided to allow all International Service Contact details to be viewed.

To Lock The Screen

When the Console is running the user is able to lock the screen to prevent accidental changes to the therapy settings. To do this press on the menu bar. When the screen is locked the display will change and show a large “padlock” icon. To unlock the screen press the bar.

Warnings and Alarms

button on the menu

The Console has several warnings and alarms; each has a different level of severity and risk associated with it: • A warning informs the user that the Console has detected a condition that might pose a potential 13

problem in the future. The user should review the warning condition and take appropriate action. • An Alarm condition informs the user that the Console has detected a condition that requires user intervention. To see examples of warnings and alarms, refer to “Troubleshooting and Warning/Alarm Conditions” on page 28. Warning

The warning will be displayed by alternating the help symbol and the yellow warning symbol in the Menu Bar. An audible warning will also sound, with the tone of the “beeps” changing to indicate increasing urgency. To view information of the warning, press and a warning/help screen will be displayed. Warnings can be ignored if the user ensures that there is no risk to the patient or therapy. To “Ignore” the warning condition, press the button, which will mute the audible warning and return the user to the main screen.

Alarm

Most Alarms cannot be ignored or muted, and the screen offers remedial action to solve the problem.

Information Indicators

The screen has “pop-up” text boxes that give information about the Console’s status and therapy settings. These text boxes appear when you put your finger on any of the symbols shown in the status bar. For example if you require information on the intermittent settings, place your finger on the symbol, and for as long as your finger is touching the symbol, the relevant information is displayed (as shown below).

Status Bar

Help Screens

Help screens are available by pressing the on the menu bar. The user can then follow the on screen instructions to rectify the issue.

14

4. System Setup These instructions detail how to setup the WoundASSIST TNP Wound Therapy System.

 Refer to Section 3, Page 10 “Controls, Indicators and Alarms” for a comprehensive description of the controls and indicators on the Console. Caution The Wound Pack is supplied sterile: • Do NOT use if the package is damaged or open. • Do NOT open the package until ready to apply the dressing. Preparing the System

Remove the Console and Canister components from their packaging. You should have the following items: • WoundASSIST TNP Console: • The Console is shipped in a “hard” case for increased protection. • A mains-powered battery charger, with adapters, is included to recharge the internal battery in the Console. • The following Console mounting accessories are included: - Bed Hook. - DIN Rail Clamp. - IV Pole Clamp. • A carry bag is also included to enable the Console to be carried or worn by the patient (e.g. over the shoulder) or fitted to a wheelchair. • WoundASSIST TNP Canister: • The Canisters are shipped in packs of five. • An odour filter and filter housing is included with each Canister to install on the rear of the Console. The WoundASSIST TNP Wound Pack: • Wound Packs are available in three sizes: • Small/Medium (15 cm x 20 cm). • Medium/Large (20 cm x 30 cm). • Extra Large (20 cm x 30 cm). • The Wound Packs are shipped in packs of five for the Small/Medium and Medium/Large, and packs of three for the Extra Large.

15

• The WoundASSIST TNP Wound Pack contains the following items: • Non-adherent wound liner. • Anti-microbial gauze. • Semi-permeable transparent film dressing. • Fenestrated (perforated) flexible silicon drain and tube-clamp. • Canister-tube connector, polyurethane tube with pre-fitted in-line connector and tube clamp. • “Y” connector. Installing the Canister

Check that there is no damage to the new Canister, specifically: • A - Canister outlet tube to the Console. • B - Retaining clip at the top of the Canister. • C - Slot in the base of the Canister. 1. Locate the bottom of the Canister securely onto the lip on the base of the Console. 2. Push the top of the Canister firmly into position until it ‘clicks’. 3. Make sure the Canister is secure by carefully trying to pull the Canister away from the Console.

Installing the Odour Filter to the Console

A

B

Setting up the Console

1. Remove the new odour filter and filter housing from their packaging. 2. Make sure the odour filter is fully located in the filter housing (A). 3. Push the filter housing (with the odour filter inside) firmly onto the rear of the Console (B). 4. Make sure the filter housing is secure. 1. Put the Console on a flat surface in either the vertical or horizontal (with the front face uppermost) position. Refer to “Console” on page 1. 2. If the Console is to be mounted directly onto a bed, DIN rail or IV pole, install the relevant hook or clamp (supplied with the Console) onto the Console by pushing the two mounting clips on the hook/ clamp into the square slots in the rear case of the Console below the filter housing. Refer to “Console Mounting Accessories” on page 5. 16