Venturi Vacuum Therapy System Technical Service Manual ver 1.6 Aug 2008

CONTENTS 1. Summary 1-1 Introduction 1-2 Classification 1-3 Convention used in the manual 1-4 Labels and symbols 1-5 Cautions 2. Technical description 2-1 Primary elements 2-2 Mechanical 2-3 Electrical 2-4 Firmware 2-5 Operating environmental specification 3. Installation and operation 3-1 Installation 3-2 Disposal 3-3 Principle of operation 3-4 Normal usage 3-5 Accessing the information and test mode 3-6 Charging options 3-7 Battery module replacement 4. On site testing and problem solving 4-1 Alarms 4-2 Basic vacuum test fro users 4-3 Vacuum and leak test with SD500 gauge 5. TS8000 service tests 5-1 PReg: to check pump exceeds -160mmHg 5-2 CAL Pump: to test and calibrate internal pump for optimum performance 5-3 Pressure sensor calibration 5-4 Updating service hours and service due date 5-5 Test comms: Tests the product – PC interface 5-6 Download: for installing a firmware update 5-7 Details: displays pump counter, battery charge and temperature 5-8 Aux input: checks canister sensor circuit. 5-9 Test LCD 5-10 Test keys 5-11 Rotor system (not used) 5-12 Case temperature: displays temperature at pcb sensor 5-13 Battery info: displays charge, volts and temperature 5-14 Soak test (not used) 6. Pump Servicing 6-1 Principle of operation 6-2 Pump specification

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7. Illustrated spares lists 7-1 External items and fasteners 7-2 Label kit 7-3 Internal items 7-4 Not used 7-5 Other items 7-6 Optional accessories

Annex A: Version history Annex B: Outline arrangement drawing Annex C: Circuit diagram

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Amendments: Issue B:

Section 3.7 added. Firmware version added on Page 1

Issue C

Updated for firmware version 1.4 Sections 3.2.4, 3.3.4 and 3.3.5 added

Issue D:

Non return valve included, section 6.3

Issue E

Firmware V1.6 Now IP51

Issue F:

Section 3.8 added

Issue 1.6:

Updated to incorporate V1.6 functions

Issue 1.6.1

Section 6.3 and 7.4 removed Section 3.6 includes ULTRA FAST Picture, page 30 corrected.

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SECTION 1: SUMMARY

1. Summary 1.1. Introduction The VENTURI™ NPWT system features a lightweight, versatile vacuum power unit which benefits from dual-power technology, offering a seamless choice of mains or battery operation. The integral battery is charge-optimised, and provides long-lasting power back-up when needed. The battery operation option allows the system to function away from a mains power supply for extended periods of time, allowing the patient full mobility during therapy, if required (optional carry case with shoulder strap available). NPWT is applied utilising the VENTURI™ wound sealing kit which includes gauze (which is applied moistened with saline), a silicone drain and transparent adhesive film. A choice of flat or channel drains are available, together with a choice of gauze sizes, according to the wound type being treated. The VENTURI™ NPWT system will benefit from careful installation and use, providing a long and effective service life. Please read this user manual in order to achieve the best possible results

1.2. Classification Product identification:-

VENTURI NPWT SYSTEM (TG600/07)

Type:-

MAINS POWER UNIT WITH BATTERY BACK-UP

Classification:

Type 2b

1.3. Conventions in this manual. •

Indicates a display:

Talley Group Venturi…………… • Capitals Indicates a key press: MODE

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SECTION 1: SUMMARY

1.4. Labels and symbols Label set: See spares list section 6.2. for part numbers: Symbols:

Product complies with the requirements of ECC93/42, and is a class 2b medical device Class II double insulated in accordance EN60601-1-2

Product must be disposed of in accordance with WEEE regulations 2006 Refer to user manual

Electrical protection type B

1.5. Cautions WARNING: Mains adaptor (if applicable) must be earthed. Before using this product ensure that: the electricity supply (if applicable) is of the type indicated on the power unit The mains lead (if applicable) is free from damage and is positioned so as not to cause an obstruction The system is not used in the presence of flammable anaesthetics Do not place power unit on or near a heat source. Never use the mains adaptor/charging unit whilst placed on top of or near to material which is flammable or can be damaged by heat. The equipment conforms to IEC 60601-1-2 for electromagnetic interference, however should the equipment be subjected to, or emission of, electromagnetic interference outside this then the unit should be reset. CAUTION! The medical professional is responsible for using his/her best medical judgement when using this system. Prior to use, the medical professional(s) treating the wound must assess how to best use the system for an individual wound.

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SECTION 2: TECHNICAL DESCRIPTION

2. Technical Description 2.1. Primary elements:

Function buttons LCD Display Outlet to drain tube

Locking knob

Disposable 600mL Canister

Sighting window

TG600/07 power unit

6v wall mounted power supply

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SECTION 2: TECHNICAL DESCRIPTION

2.2. . Mechanical. 2.2.1. Dimensions: See Annex B 2.2.2. Mass: Power unit, no canister: Power unit and empty canister: Power unit and full canister: Power unit, empty canister, boxed: 2.2.3. IP rating:

1.89kg 2.18kg 2.75kg 2.5 kg

IP 51

2.2.4: Batteries: removable module, engaged from vessel side of unit. 2.2.5. Labelling: Functional / warning labels: see section 1.4 and 7.2 2.2.6. Primary materials: Case: Flame retardant ABS, (colour reference: blue grey, Red: 227 Blue: 230 Green: 229 Canister: Flame retardant ABS, smoke grey

2.3. Electrical 2.3.1. Operating voltage:

6v dc normal, 8v peak non battery

2.3.2 Peak current (operating without batteries): 850mA RMS 2.3.3. Power supply: 15V DC 4A, UL60601-1 Medically Approved PSU I/P: 100-240 V, 50-60 Hz, 2A max

2.3.4. Battery type: Nickel metal hydride, 6v, 2.5Ah with fuse

2.4. Firmware The output of the compiler is 96-10-17-01.hex which is programmed into the PIC18F4525. Sub versions are as follows: See Annex A for version history

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SECTION 2: TECHNICAL DESCRIPTION

2.5. Environmental specification 2.5.1. Climatic specification Operational temperature Range

15°C to 35°C

Storage temperature Range

5°C to 45°C

Operational humidity Range

10% to 75% (non condensing)

Storage humidity range

10% to 90% (non condensing)

2.5.2. Structural integrity Bump: 40g, 50ms rise time, half pulse, on any corner 2.5.3. Longevity: Design life: 5 years Service interval: 7500 hours

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SECTION 3: INSTALLATION & OPERATION

3. Installation and operation. 3.1. Installation An unused canister must be attached and locked to the power unit. The push and turn connector on the drain end or extension tube must be inserted in the canister prior to operation of the unit.

The canister is a disposable item. It is expected to be in use typically for 1 week. IMPORTANT: When in use, Venturi must not exceed a tilt of 30 degrees in any axis. Venturi can be used in the following types of installation: •

On a horizontal surface

•

In a bed side carrier.

•

In a carry case with a shoulder strap.

3.2. Disposal The vessel is disposed of when it is filled to capacity. No tools are necessary achieve this. When ready for disposal, clamp off the drain, remove the drain connector, and put the rubber stopper in the top of the canister in the now open entry hole. Disposal must be consistent with local health authority policy.

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SECTION 3: INSTALLATION & OPERATION

3.3. Principle of operation. 3.3.1. Functional components

6v DC power supply

TS8000

Pump mounting pins

Battery module

Air inlet and non return valve

Comms dataport

Receptacle for canister sensor pins

42R single reed pump

Pump mounting suspension springs

Silencer Pump impact snubbers

Battery closure

Inlet from canister

Canister location holes (4 positions)

Locking knob

Exhaust

Connector for canister sensor

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SECTION 3: INSTALLATION & OPERATION

Internal pump Drain

Canister

Pump dc electrical supply Control pcb pressure sensor

3.3.2. Control system. Air is vacuumed from the canister and drain tube by the 42R internal diaphragm pump. The required negative pressure (with respect to atmospheric) is set by default or by the user. A pressure sensor is mounted on the control PCB, and the system compares the actual vacuum with that required. DC electrical power is provided to the 42R vacuum pump on demand. The pressure regulation algorithm provides the following profile at the end of the drain tube.

Because there is a time based reduction in pressure of aprox. 10mmHg over the length of the drain, the regulation pressure at the sensor is elevated to compensate The pressure regulation algorithm operates between the following limits: -40 to -100mmHg: Set vacuum + 20mmHg and Set vacuum -10mmHg -105 to -120mmHg: Set vacuum and set vacuum -10mmHg.

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SECTION 3: INSTALLATION & OPERATION

Continuous pressure regulation continues if the system is in continuous mode. Operation is 5 minutes on, two minutes off when it is in intermittent mode. Note that the option of continuous or intermittent was introduced at V1.6. 3.3.3. Other functions: The control pcb also provides the following functions: • User display: 16 characters wide x 2 high. (see section 5) and associated firmware

•

•

Audible alarm

•

Interface to battery module and charging circuit

•

System diagnostics See section 4 & 5

External communication: The unit can be interfaced to a PC via a Talley USB adapter kit to enable the following functions:

- Editing of DATA set - Resetting of hours to next service and service due date. - Downloading of hex file programmes, for example programme updates. (Section 5.6) 3.3.4. Variable frequency algorithm and temperature compensation. The system operates using a Talley designed control PCB (TS8000) which provides variable frequency of the oscillating reed in the pump according to the back-pressure-loading and performance target expected of it at any point in time.

Pump frequency

Pump frequency

Actual vacuum

Set vacuum

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PCB Temperature

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SECTION 3: INSTALLATION & OPERATION

There will be conditions of high flow and low pressure resistance for which the pump frequency reduces, allowing greater movement of the diaphragms , and conversely low flow and high pressure resistance, in which case the pump frequency increases. The ability to also vary frequency with temperature has been incorporated. As rubber pump components stiffen with reduced temperature, pump frequency increases to compensate. Temperature and pump calibration can be set by service engineers, details given in section 5 By optimising operating frequency in this way, up to 3 litres / min is obtained at mean operating pressures and the system can maintain peak vacuums at 10 deg C

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SECTION 3: INSTALLATION & OPERATION

3.3.5. Canister detail.

Blanking cap: shown in stowed position.

Hole for quarter turn locking knob.

Push and turn drain tube connector (drain tube not shown) for media entry

Un-textured window, with level indications in mls

Part number for reordering

Filters and air outlet to TG600/07 unit

Near full and vessel attached indication sensor

Location peg, 4 positions

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SECTION 3: INSTALLATION & OPERATION

Air is vacuumed from the canister at the outlet port via a filter set. On versions up to and including 1.5, the filters set comprises a 10mm diameter moisture resistant filter and a carbon antibacterial filter. On V1.6, it comprises a 25 x 10mm moisture resistant filter, under which is 3ccs of carbon granules, retained in an enclosure that is integral with the canister moulding. As the canister is semi translucent, the differences are visible. Note that V1.5 canisters can be used on a V1.6 Venturi and vice versa. Four sensor pins are inserted in the interfacing side of the canister. Two of these are used to confirm that the canister is correctly attached. The product will not run if this circuit is open. The other two are used to detect that the canister is near full, when the contact of exudates on them closes a signal circuit. The system will cease to function, and a message displayed that the canister is full. The vessel comprises a flat rear half and a profiled front half that are bonded together using UV cured adhesive. A system of baffles is incorporated inside the vessel to ensure against early activation of the ‘near full’ sensors. Volume B

Blind hole for blanking cap stowage

Fluid entry position Capacity at normal angle

Air outlet position

Stiffening webs

Sensor position

Window for viewing fluid level

Figure 4

Volume A

Volume C

Volume A and B have to be occupied and filled with exudates before filling of C commences. A desiccant is inserted in the canister during bonding to solidify the exudates. On versions up to 1.5, this comprised two sachets of 1.75g, and at V1.6 it comprises 1 sachet of 5g.

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SECTION 3: INSTALLATION & OPERATION

3.3.6. Low vacuum detection This facility was introduced at V1.4, to improve low vacuum warning at the lower settings counting the number of half cycles performed by the pump reed every 5 seconds. The systems records this count, and compares it with look up data for each vacuum setting. With feed back from users, particularly instances for of large dressings, these values have been amended at V1.6 as follows:

Set vacuum 40 45 50 55 60 65 70 75 80 85 90 95

Counter threshold 207 221 236 250 265 279 293 308 322 336 351 365

If the counter value is exceeded, the low vacuum warning will display and sound. Values of 100 – 120mmHg: If the pump does not cease demanding for 60 seconds, the low vacuum warning sounds. Section 5.7 shows how the counter value can be accessed via the test mode. It is not intended to be visible to users.

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SECTION 3: INSTALLATION & OPERATION

3.4. Normal use The system is designed to be as simple to operate as possible. A very basic user interface is provided, with other, less accessible menus available to service engineers for testing the product. POWER ON RUN / STOP

MUTE

MODE: CONTINUOUS/ INTERMITTENT SELECT

UNLOCK LIGHT

3.4.1. Basic use, battery operation. Press POWER ON to power up into ‘standby mode’. Requires three second press to avoid inadvertent switch on, followed by 1 second beep Pressures can be modified in STANDBY, in 5mmHg increments between 40mmHg and 120mmHg using the up and down arrow keys. CONT, for continuous mode operation is default. To select intermittent, the MODE selection key is pressed for 3 seconds. The display illuminates for 10 seconds when powered up into STANDBY. Battery state is shown graphically as a ‘fuel gauge’. When no battery is detected, the system displays ‘NO BATT’. RUN/STOP starts operation of the system. If intermittent mode is selected, it runs for 5 minutes on, 2 minutes off. Product Brand, pressure and battery charge are displayed. When powered up, press RUN/STOP to run / stop the system. This requires an immediate press, with a beep. Pressure can be changed when the system is running for up to 1 minute only. After running for 1 minute, UNLOCK key needs to be pressed for 3 seconds to ‘unlock’ and allow further pressure adjustment. This is to prevent inadvertent change of pressure when in use. It ’ re-locks’ after 1 minute of inactivity. The display shows ‘L’ when keys are locked.

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SECTION 3: INSTALLATION & OPERATION

Press UNLOCK for 3 seconds then RUN/STOP for 3 seconds to revert back to standby mode. From standby mode the unit will self switch off after 1 minute of inactivity, with three beeps. Pressing MUTE also switches the unit off. LIGHT: Illuminates the display for 10 seconds. MUTE: silences warning alarms. Default pressure: 80mmHg on each power up. The previous setting is recalled between power up and run. The system will self power off when inactive for 1 minute when on battery only operation. 3.4.2. Basic use, mains dc attached. Use is the same as with battery only except that the battery capacity gauge scrolls left to right when charging is in progress. The display is a representation of the m-amp hours of charge. Also, the unit cannot be fully powered down when the mains dc is attached. 3.4.3. ‘No canister’ This warning occurs when no canister is fitted, or when the electrical connection in the canister is not complete. The system displays the warning for a short duration, provides an alarm, and reverts to standby mode. 3.4.4. ‘Canister full’ This warning occurs when the electrical connections in the canister detect moisture. The system displays the warning for continuously, provides an alarm, and remains as such until the canister is removed. It then reverts to standby mode. On V1.6, the canister full warning is redisplayed every 10 minutes. Note that on earlier firmware versions, the alarm was only momentary. 3.4.5. The power supply and charging display. Charging is automatic on Venturi when the power supply is engaged, if battery charging is required. The charging display will scroll left to right during charging, with the charge state being shown by the vertical lines on the display

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SECTION 3: INSTALLATION & OPERATION

3.5 . Accessing the information and test mode. 1. Push and hold down during 2.

2. Push & release

•

With Venturi powered off, insert the mains dc adapter.

•

Press and hold the UNLOCK key.

•

With the UNLOCK key pressed, momentarily press the POWER on key and release

•

When the tone has stopped, release the UNLOCK key

•

The system will display

Charge menu CHARGE AUTO

Continued pressing of the power key provides access to the following: •

Service Engineers test mode – The display show CAL – see section 5

•

Dallas Write: This mode is used to write battery information for optimum charging.

•

Read CTemp: Press the MODE button to show battery pcb chip temperature in deg C. This is important to ensure the battery pack is not at excessive temperatures during charging.

On earlier versions of Venturi this function was accessed directly by pressing and holding the i (DATA) key. As this key is used for continuous / intermittent mode selection on V1.6, the information mode has been moved to this location. When the display shows CAL, key to show ‘Information’.

scroll up one position with the UP ARROW

Press the MODE button and the information set will be displayed.

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