WoundASSIST TNP System Service Manual

WoundASSIST TNP Console Service Manual

Contents

CONTENTS CHAPTER 1 Introduction... 1 About This Manual... 1 Numbering and Cross-Referencing in this Manual... 1 Warnings, Cautions and Notes... 1 General Warnings... 1 About the WoundASSIST TNP System... 1 General... 1 Console... 3 Wall Power Supply Unit... 3 Canister... 4 Console Mounting Accessories... 5 Console Operating Modes... 5 Therapy Modes... 5 Console Schematic Diagrams... 7 Mini-SD Memory Card... 7 Carry Bag (refer to Figure 9)... 7 Controls and Indicators... 8 LCD Screen... 8 Console Controls and Indicators... 8 Run Mode... 8 Power/Alarm Indicator... 8 Console Screen Buttons and Icons... 9 To Change the Care Options or Setup Options... 10 Care Options... 10 Setup Screen... 11 To Lock/Unlock The Screen... 12 Information Indicators... 13 Warnings and Alarms... 14 Help Screens... 16 System Setup... 17 Preparing the System... 17 Installing the Canister... 17 Setting up the Console... 18 Removing the Old Canister... 18

CHAPTER 2

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Troubleshooting... 1 Critical System Alarms... 1 General Warnings... 1 General Alarms... 2 Help Screens... 10 General Therapy Troubleshooting... 10

CHAPTER 3 Maintenance... 1 General... 1 Rental Returns... 1 Service... 1 Maintenance Checks... 1 Service Console Data... 2 Replacing a Mini-SD Memory Card... 3 Changing the operating language when you cannot understand the text on the buttons... 4

CHAPTER 4 Testing... 1 Inspection and Test Procedures... 1 Diagnostic Self-Test Routine... 2 Basic Console Function Test... 4 Checking the Compressor and Pressure Transducer... 4 Checking the Pneumatic Valve on the Control PCB Assembly... 6 Checking the Canister Level Sensor... 7 Checking with No Canister Fitted... 7 Checking with a Full Test Canister Fitted... 7 Recalibrating the Canister Level Sensor... 8 Rechecking the Level Sensor with No Canister Fitted... 10 Rechecking the Level Sensor with a Full Test Canister... 10 Checking the Console Tilt Mechanism... 12 Electrical Safety Testing of the Console... 13 Electrical Safety Testing of the Wall PSU... 13 Electrical Safety Tests - Class II (Double Insulated)... 13 Test Equipment... 13 Insulation Resistance Test... 13 Dielectric Strength Test (Flash Test)... 13

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Inspection and Test Procedures... 1 General... 1 Equipment Required... 1

CHAPTER 6 Upgrading the Console Software... 1 General... 1 Upgrading all the Software on the Console... 1 Checking the Version of the Main Console Software... 1 Upgrading the Display Controller Software using the Installer SD Card... 2 Upgrading the Main Console Software using the Installer SD Card... 3 Testing the Console using the Installer SD Card... 3 Completing the Software Upgrade Procedure... 3

CHAPTER 7 SD Communicator User Guide... 1 General... 1

CHAPTER 8 Console Repair... 1 General... 1 Testing... 1 Inspection and Test Procedures... 1 Removing the Rear Case Assembly... 3 Installing the Rear Case Assembly... 3 Removing the Compressor Assembly... 5 Installing the Compressor Assembly... 7 Removing the Top Case Assembly from the Front Case Assembly... 9 Installing the Top Case Assembly onto the Front Case Assembly... 9 Removing the Battery Pack... 11 Installing the Battery Pack... 11 Removing the Display Interface PCB Assembly... 13 Installing the Display Interface PCB Assembly... 13 Removing the Handle... 15 Installing the Handle... 15 Removing the Control PCB Assembly... 17 Installing the Control PCB Assembly... 17 Removing the E-Field Label... 19 Installing the E-Field Label... 19

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CHAPTER 9 Technical Specification... 1 Console... 1 Wall Power Supply Unit (PSU)... 2 Canister... 3 Wound Packs... 3

CHAPTER 10 Parts List... 1 Mini SD Memory Cards... 1 Console Parts List... 1

CHAPTER 11 Service Contact Details... 1

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Introduction

CHAPTER 1 INTRODUCTION 1

About This Manual

Huntleigh Healthcare strongly recommend that their equipment is only serviced by trained personnel and provide courses for customers who wish to become licensed to service their own equipment. In no event will Huntleigh Healthcare be responsible for any service performed by customers or third parties. This manual contains information on the maintenance, servicing, repair, troubleshooting and testing for the WoundASSIST ® TNP Console. Read and understand this manual before attempting to service or repair the equipment.

Numbering and Cross-Referencing in this Manual For all chapters in this manual: • Page, section and paragraph numbering re-start at “1”. • Figure and table numbering continue from the previous chapter. • Cross-references which include a chapter number (and/or chapter title) refer to text in a different chapter. Cross-references which do NOT include any chapter number (or chapter title) refer to text within the same chapter.

Warnings, Cautions and Notes WARNINGS given in this manual identify possible hazards in procedures or conditions which, if not correctly followed, could result in death, injury or other serious adverse reactions. CAUTIONS given in this manual identify possible hazards in procedures or conditions which, if not correctly followed, could result in equipment failure or damage. Notes given in this manual are used to explain or amplify a procedure or condition.

General Warnings WARNING: BEFORE PERFORMING ANY MAINTENANCE, REPAIR OR TESTING PROCEDURES, REMOVE ANY USED CANISTER OR WOUND PACK MATERIALS (AND DISPOSE OF THEM IN ACCORDANCE WITH LOCAL PROTOCOL), AND MAKE SURE THAT THE CONSOLE HAS BEEN ADEQUATELY DECONTAMINATED. WARNING: ALWAYS USE A CLEAN CANISTER TO TEST THE CONSOLE; DO NOT USE AN OLD CANISTER AS THERE COULD BE POTENTIALLY HARMFUL ORGANISMS IN THE EXUDATE.

2

About the WoundASSIST TNP System

General WoundASSIST TNP provides a non-pharmacological, physical method of promoting wound healing and works by the local application of sub-atmospheric pressure (suction) across a wound. The WoundASSIST TNP system comprises (refer to Figures 1 and 2): • A Console which provides the suction. • A disposable Canister on the side of the Console to collect the exudate. • A sterile Wound Pack. WoundASSIST TNP therapy involves the use of a primary open-pored, non-adherent material placed directly over the wound bed. The soft, flexible wound drain is wrapped in further moistened gauze and placed in the wound bed, and connected to the wound-drainage tube. The end of the wound-drainage tube is attached to the canister on the side of the WoundASSIST TNP console. The console provides a controlled vacuum, and excess wound fluid is drawn into the sealed canister for subsequent disposal. The entire wound area is covered with a transparent, semi-permeable adhesive film dressing which is secured to healthy skin around the wound margin; the film dressing prevents the ingress of air and allows a partial vacuum to form within the wound.

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Carry Handle

LCD Screen Power / Alarm Indicator

On / Off Button

Connector for Wall PSU Retaining Clip for Canister

Graduations for Vertical and Horizontal Orientations Connector for Wound-Drainage Tube Canister NOTE: The Canister Plug is not shown for clarity Figure 1 - Console with Canister (Front View)

Non-Slip Feet Carry Handle

Replaceable Odour Filter and Filter Housing

Console Accessory Mounting Slots

Canister

Figure 2 - Console with Canister (Rear View)

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Console 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 (refer to Figure 3). The LCD screen on the Console automatically rotates through 180° when the Console is moved between the vertical and horizontal orientations. Note: 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.

 Vertical



Horizontal with Front Face Uppermost

Tilted

Horizontal with Front Face on Underside Figure 3 - Console Orientations

Wall Power Supply Unit 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 Wall Power supply Unit (PSU). The Console operates from a DC power supply, as follows: 1. The Console has an internal high-capacity, rechargeable battery (lithium ion) which powers the Console directly. An icon on the LCD screen indicates the battery charge status. 2. The WoundASSIST TNP Wall PSU is connected to the mains/power supply and then connected to the Console. This Wall PSU provides a DC output voltage which will: • Power the Console directly. Note: The Console will operate normally from the Wall PSU even if the internal battery has a fault, or is not detected by the system. • Recharge the internal battery. 3. An icon on the LCD screen indicates that the Wall PSU is connected to the Console. The electrical input to the WoundASSIST TNP Wall PSU is: 1. Input voltage = 100-240 Vac. 2. Input frequency = 50/60 Hz. 3. Input current = 700mA (max).

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Mains/Power Adapters

To Console Figure 4 - WoundASSIST TNP Wall PSU (Power Supply Unit)

The Wall PSU 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 Wall PSU until it clicks into position (refer to Figure 4). Note: You must fit the adapter to the Wall PSU before use. To recharge the internal battery in the Console: 1. Plug the cable connector on the Wall PSU into the connector on the side of the Console. 2. Plug the Wall PSU into the mains/power socket.

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 (refer to Figure 5). The Canister incorporates a bio-filter designed to remove potentially harmful organisms (which may originate in the wound) from the air expelled to the environment. 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: it can hold up to 500 ml of fluid when vertical, and up to 400 ml when horizontal. Note: The Canister is single use only.

Canister Inlet (from Wound) Canister Outlet (to Console)

Canister Plug Figure 5 - Canister

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Bed Hook

Introduction

IV Pole Clamp

DIN Rail Clamp

Figure 6 - Console Mounting Accessories

Console Mounting Accessories The following mounting accessories are supplied with the Console (refer to Figure 6): • 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 Operating Modes The Console has the following operating modes: 1. Run Mode: the Console is supplying therapy. 2. Therapy Stopped Mode: the Console has stopped supplying therapy. 3. LCD Screen Backlight Extinguished: • In Run or Therapy Stopped Modes, if no buttons on the LCD screen have been pressed in the last 10 minutes, the LCD screen backlight will be extinguished. • If you touch the LCD screen while the backlight is extinguished, the backlight will be illuminated again. • However, if a Warning or Alarm event occurs or the Wall PSU is plugged in whilst the LCD screen backlight is extinguished, the backlight will be illuminated again and the 10 minute timer will restart. • If no buttons on the LCD screen are pressed for a further 60 minutes after the backlight is extinguished, and the Console is running on battery power and is in Therapy Stopped Mode, the Console will switch off automatically.

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.

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Compressor / Vacuum Pump

Canister Vacuum Port

White

White White Clear Tube

White

Pressure Transducer Filtered Outlet

White

White

White

White Rear Case

Solenoid

Blue Tube

Unused Connection

Red Tube

Figure 7 - Pneumatic Schematic of Console

2 x USB Ports

Stereo Jack Socket DC Jack Socket

Mini-SD Memory Card

Display Interface PCB Wall PSU Touchscreen

LCD

Vacuum Compressor

E-Field Sensor Label

Control PCB

Battery Pack Figure 8 - Electrical Schematic of Console

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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.

Console Schematic Diagrams Refer to Figure 7 for the pneumatic schematic and Figure 8 for the electrical schematic.

Mini-SD Memory Card There is a mini-SD memory card installed in the Console (refer to Figure 8), in the top case assembly underneath a removable data port cover. Note: The Console will NOT operate if the memory card is not fitted or not detected.

Carry Bag (refer to Figure 9) As the Console is battery-operated, it is completely portable. 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

Carry Strap Canister Inlet

Figure 9 - Carry Bag

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Controls and Indicators

LCD Screen Refer to Figure 10 for the default screen when the Console is in Therapy Stopped mode. Note: There will be an audible “beep” when any button on the screen, or the On/Off button, is pressed. Menu Bar Power / Alarm Indicator

On / Off Button LCD Screen

Status Bar Figure 10 - Typical Console Screen in Therapy Stopped Mode

Console Controls and Indicators 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 and hold the On/Off button for approximately 4 seconds until the Power/Alarm indicator is extinguished; this indicates that the Console has switched off and you can release the On/Off button. Note: The Console is switched off this way regardless of whether the Wall PSU is connected to the Console or not.

Run Mode Refer to Figure 11 for the default screen when the Console is in the Run mode.

Figure 11 - Standard Default Screen in Run Mode

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 (refer to Table 1) Table 1 - Power/Alarm LED Status LED Status

Description

Green, Flashing

1. The Console is running the power-up self-test. 2. The Console is being initialised when the Wall PSU is first connected.

Green, Constant

The Console is active, and is not being recharged.

Yellow, Constant

The Console is being recharged.

Red, Flashing

Alarm condition.

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Console Screen Buttons and Icons Table 2 details the buttons and icons on the screen in Run and Therapy Stopped modes. Table 2 - Buttons and Icons in Run and Therapy Stopped Modes 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. Refer to “Help Screens” on page 16. The Warning triangle icon alternates with the Help symbol when a Warning condition has been detected. Refer to “Warning” on page 14. The Battery icon indicates the relative state of charge in the internal battery (for both charging and discharging). Refer to “Wall Power Supply Unit” on page 3. The Lightning Strike icon indicates that the Wall PSU is connected to the Console. Refer to “Wall Power Supply Unit” on page 3. The Chevron icon indicates that the Console is in Run mode. The icon will sequentially “scroll” from 1 chevron through to 5 chevrons (and then repeat the sequence) 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). Intermittent therapy mode (Int icon). The therapy settings can be changed on the Care Options screen. Refer to “Therapy Mode” on page 10. The Intensity icon on the status bar indicates the therapy intensity currently set. The Intensity settings can be changed on the Care Options screen. Refer to “Therapy Intensity” on page 10. The Negative Pressure icon on the status bar indicates the level of negative pressure being applied at the wound bed. The Negative Pressure is changed on the Care Options screen. Refer to “Therapy Pressure” on page 11.

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To Change the Care Options or Setup Options •

Press Care Options to display the Care Options screen, where you can change the Therapy Mode, Therapy Intensity and/or Therapy Pressure. • Press Setup to go to the Setup screen, where you can change the Intermittent Setup, the Language, and view Service information for the Console (refer to Figure 13). Note: There is a timeout on all screens under the Main screen: if a new screen is selected and no button is pressed for 30 seconds, the display will revert to the previous screen.

Care Options The Care Options screen allows you to change the Therapy Mode, Therapy Intensity and Therapy Pressure (refer to Figure 12). 1. You can display the Care Options screen while the Console is in the Run or Therapy Stopped modes. 2. The Therapy Intensity and Therapy Pressure can be changed when the Console is in both the Run or Therapy Stopped modes. 3. The Therapy Mode can only be changed when the Console is in the Therapy Stopped mode. Pressing the

button next to the Therapy Mode in the Run mode has no effect.

Figure 12 - Care Options Screen Therapy Mode The Console has two Therapy Modes: •

Continuous. This allows the Console to apply a pre-defined 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 pre-defined 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.

Note: The Therapy Mode can NOT be changed when the Console is in the Run mode. 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.

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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. Press the

button next to the

Negative Pressure icon to scroll through from -25 mmHg to -200 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. Confirm Changes When the Therapy Mode, Therapy Intensity and Therapy Pressure settings have been adjusted, press Accept to change the Care Options, and when prompted Are you sure you wish to change Care Options? confirm by pressing Yes.

Setup Screen The Setup screen allows you to change the Intermittent Setup and the Language, and view Service information for the Console (refer to Figure 13).

Figure 13 - Setup Screen Intermittent Setup Press Intermittent Setup to display the Intermittent Setup screen, where you can change the intermittent therapy settings (refer to Figure 14). 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 (which are the default values). To change the intermittent time settings, press the

button and the number to the right will change

in one minute increments. Press Accept to change the Intermittent Setup, and when prompted Are you sure you wish to change Intermittent Setup? confirm by pressing Yes.

Figure 14 - Intermittent Setup Screen Language Selection Press Language to display the Language screen, where you can select a new operating language for the Console (refer to Figure 15). Press the

or

button to scroll through the available languages.

Press Accept to change the Language Selection, and when prompted Are you sure you wish to change Language? confirm by pressing Yes.

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Figure 15 - Language Selection Screen Service Functionality Press Service to display the Service screen, where you can view Console Data and the International Service Contact details (refer to Figure 16).

Figure 16 - Service Screen Press Console Data to display the Console Data screen, where you can view various parameters, including the current software version, Alarm occurrences, LCD screen brightness, therapy run time, Console time and date, and battery usage data (refer to Figure 17).

Figure 17 - Console Data Screen Press Contacts to display an HTML Contacts page, where you can scroll down, and select and then view the country/region and its contact details.

To Lock/Unlock The Screen You can lock the screen to prevent accidental changes to the therapy settings. To do this press the

button on the Menu bar, and a Lock Dialog screen will be displayed. Press

Yes and the Locked screen will be displayed (refer to Figure 18). If the screen is touched anywhere other than the To unlock the screen press the

button, a Help screen will be displayed.

button on the Menu bar, and an Unlock Dialog screen will be

displayed. Press Yes and the Console will return to the original “calling” screen before it was locked.

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Figure 18 - Locked Screen

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 icon, and for as long as your finger is touching the symbol, the relevant information is displayed (refer to Figure 19).

Pop-Up Text Box

Status Bar Figure 19 - Intermittent Settings Pop-Up Text Box

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Warnings and Alarms

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 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 Chapter 2 “Troubleshooting”, Page 10, “General Therapy Troubleshooting”. Warning When a Warning condition is detected: • A yellow Warning triangle icon will alternate with the blue Help icon in the top right of the Menu bar (refer to Figure 20). • An audible Warning will also sound, with the tone of the “beeps” changing to indicate increasing urgency.

Figure 20 - Warning Condition To view information of the Warning, press the

and a Warning information screen will be

displayed, e.g. Battery Low Warning (refer to Figure 21). If you press the in the top right of the Warning information screen, a Help screen will be displayed (refer to “Help Screens” on page 16). Warnings can usually be ignored if the user makes sure that there is no risk to the patient or therapy. To “ignore” the Warning condition, press Ignore on the Warning information screen, which will mute the audible Warning and return the user to the main screen; in most cases, the yellow Warning triangle icon will continue to alternate with the blue Help icon

.

Figure 21 - Battery Low Warning Screen For some Warning conditions, e.g. Pressure Leak (refer to Figure 22), if you press Details, a further set of Warning information screens are displayed (refer to Figure 23) which will aid troubleshooting. On the Warning information screens: • If you press Cancel then the user is returned to the main Pressure Leak Warning screen (refer to Figure 22), and the therapy will continue. • If you press Next then the next troubleshooting screen is displayed.

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Figure 22 - Pressure Leak Warning Screen

Figure 23 - Pressure Leak Warning Troubleshooting Screen

Alarm Alarm conditions will be triggered when either of the following occur: • A Warning condition is “ignored” (refer to “Warning” on page 14) but has not been passed or cleared, e.g. a continued Battery Low (refer to Figure 21). • An instantaneous Alarm condition has been detected, which was NOT preceded by a Warning condition, e.g. Power Failed or Memory Card Error.

Figure 24 - Battery Empty Alarm Screen When an Alarm condition is detected: • The Power/Alarm indicator on the top of the Console will flash red. • An audible Alarm will also sound, with the tone of the “beeps” changing to indicate increasing urgency. • An Alarm information screen will be displayed, e.g. Battery Empty Alarm (refer to Figure 24). Alarms can NOT be “ignored” or muted, and the screen offers troubleshooting action to solve the problem. If you press the in the top right of the Alarm information screen, a Help screen will be displayed (refer to “Help Screens” on page 16).

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