Venturi Vacuum Therapy System Technical Service Manual ver 1.5 Jan 2008

Venturi System Service Manual Issue F

CONTENTS 1. Summary definition 1.1. Introduction 1.2. Classification 1.3. Labels and symbols 1.4. Cautions 2. System definition 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. Principle of operation 3.3. Normal usage 3.4. Charging options 3.5. Alarms 3.6. Battery module replacement 3.7. Service engineer diagnostics. 3.8 Confirmitry testing for service engineers 4. TS8000 service tests 4.1. Calibration check 4.2. ADC (analogue to digital converter) 4.3. Test LCD 4.4. Test keys 4.5. Test pump 4.6. Rotor system (not used) 4.7. Test PReg (Pressure regulation) 4.8. Test comms 4.9. Auxiliary input test 4.10. Case temperature test 4.11. Battery information 4.12. Soak test 4.13. Download 4.14. Details 4.15. Changing service hours. 5. Pump Servicing 5.1. Principle of operation 5.2. Pump specification 5.3. Servicing 6. Illustrated spares lists 6.1. External items and fasteners 6.2. Label kit 6.3. Internal items 6.4. Internal pump Annex A: Outline arrangement drawing

Page 2

Venturi System Service Manual Issue F

Page 3

1. Summary definition 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

Venturi System Service Manual Issue F

Page 4

1.3. Labels and symbols: 1.3.1. Label set: See spares list section 6.2. for part numbers: 1.3.2. 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

1.4. 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.

Venturi System Service Manual Issue F

Page 5

2. System definition: 2.1. Primary elements:

Function buttons LCD Display Outlet to primary drain tube Locking knob

Cannister

Sighting window

TG600/07 power unit

Venturi System Service Manual Issue F

Page 6

2.2. . Mechanical. 2.2.1. Dimensions: See Annex A 2.2.2. Mass:

3.1kgs

2.2.3. IP rating:

IP X0

2.2.4: Batteries: removable module, engaged from vessel side of unit. 2.2.5. Labelling: Functional / warning labels: see section 7. 2.2.6. Primary materials: Case: Flame retardant ABS, blue grey comprising

Red: 227 Blue: 230 Green: 229

Vacuum vessel: see section 6.2 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: <>

2.4. Software / Firmware The output of the compiler is 96-10-17-01.hex which is programmed into the PIC18F4525. Operating vacuum: -40 to -120mmHg This manual refers to firmware version 1.5

Venturi System Service Manual Issue F

Page 7

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

Venturi System Service Manual Issue F

Page 8

3. Installation and operation. 3.1. Installation An unused canister must be attached and locked to the power unit. The check valve on the drain 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. 3.1.1. On a fixed horizontal surface. When fitted to the TG600/07 unit, the assembly must not exceed 30 degrees in any axis. 3.1.2. In a carry case with a shoulder strap: See section 8. The system is functions when tilted up to 30 degrees from vertical in any direction. 3.1.3. In a wire frame holder for use at the bedside. The holder is designed to hang on a square section on bed frame, dimensions 40mm x 40mm square section or 40mm diameter. 3.1.4. The vessel is disposed of when it is filled to capacity. No tools are necessary achieve this. Vessel replacement is on average once a week, when it at capacity. No special disposal requirements are understood to be required for the used canister.

Venturi System Service Manual Issue F

Page 9

3.2. Principle of operation.

TS8000 PCB

Battery module

6v DC power supply

(Air inlet and non return valve not shown) Comms dataport Air inlet from PA758

42R single reed pump

Receptacle for vessel sensor pins

Pump mounting suspension springs Pump impact snubbers

Venturi System Service Manual Issue F

Page 10

3.2.1. Control system. Air is vacuumed from the vessel and drain tube by the 42R pump. The required negative pressure 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 hysteresis in the length of the drain, the regulation pressure at the sensor is between: -40 to -100mmHg: Set vacuum + 20mmHg and Set vacuum -10mmHg -105 to -120mmHg: Set vacuum and set vacuum -10mmHg. Continuous pressure regulation continues. 3.2.2. 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 technology System diagnostics See section 5.3 and 5.4 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. - Uploading of hex file programmes, for example programme updates.

Venturi System Service Manual Issue F

Page 11

3.2.3. Variable frequency algorithm and temperature compensation. The system operates using a Talley designed control PCB which provides variable frequency of the oscillating reed (see figure) according to the backpressure-loading and performance target expected of it at any point in time. There will be conditions of high flow and low pressure resistance, and conversely low flow and high pressure resistance. These conditions according affect the stiffness of certain components and therefore affect their natural frequencies of vibration. By optimising operating frequency in this way, up to 3 litres / min is obtained at mean operating pressures. 3.2.3. Canister usage. Push and turn drain tube connector (drain tube not shown) for media entry

Blanking cap: shown in stowed position.

Un-textured window, with level indications in mls

Part number for reordering Hole for quarter turn locking knob.

Filters and air outlet to TG600/07 unit Near full and vessel attached indication sensor

Location peg, 4 positions

Venturi System Service Manual Issue F

Page 12

Air is vacuumed from the canister at the outlet port via a filter set. The filters set comprises a hydrophobic filter to prevent liquid thoroughfare and a carbon antibacterial filter. Two of the four sensor pins are used to confirm that the canister is correctly attached. The product will not run if this circuit is open. The vessel comprises a flat rear half and a profiled front half that are ultrasonically welded together. 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

Venturi System Service Manual Issue F

Page 13

3.2.4. Low vacuum detection This facility has been introduced at V1.4, to improve low vacuum warning at the lower settings. Use is made of 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:

Set vacuum 40 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120

Counter threshold 207 221 236 250 265 279 293 308 322 336 351 365 380 394 408 423 437

If the counter value is exceeded, the low vacuum warning will display and sound. Section 4.14 and 4.14.2. shows how the counter value can be accessed via the test mode. It is not intended to be visible to users.

Venturi System Service Manual Issue F

Page 14

3.3. Normal use The system is designed to be as simple 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

INFO

MUTE

RUN / STOP

UNLOCK LIGHT

3.3.1. 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 10mmHg and 120mmHg using the up and down arrow keys. The display illuminates for 10seconds when powered up into STANDBY. Battery state is shown graphically as a ‘fuel gauge’. When no battery is detected, the system displays ‘No batt’. Pressing RUN/STOP starts operation of the system 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. Press RUN/STOP to revert back to standby mode. This requires 3 second hold and a beep to indicate unit is stopped. From standby mode the unit will self switch off after 1 minute of inactivity, with three beeps. Pressing MUTE also switched the unit off. LIGHT: Illuminates the display for 10 seconds.

Venturi System Service Manual Issue F

Page 15

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. 3.3.2. 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. 3.3.3. INFO Requires a three second press to invoke. The following information is displayed : Last 5 faults and the hours run at which each occurred Software version and part number Bootloader identification Hours run total Hours to service Hire time (optional) Product code (optional) Serial number (optional) Last service date Owner (optional) Contact name (optional) Telephone: (optional) Hospital: (optional) Ward (optional) Patient (optional) Reference (optional) The menu is exited by an immediate of the INFO key. DATA list or after 1 minute of inactivity. The system self switched off after 1 minute of inactivity when in DATA mode. 3.3.4. ‘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. This is unchanged from earlier firmware versions. 3.3.5. ‘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. Note that on earlier firmware versions, the alarm was only momentary.

Venturi System Service Manual Issue F

Page 16

3.4. Charging options: Because ease of use is of primary importance on this system, the charging options are within a separate menu, requiring the following to access it: With the UNLOCK key pressed and held, insert the mains dc adapter. Momentarily press the POWER on key and release Release the UNLOCK key The system will display

Charge menu CHARGE AUTO

Charging options can be accessed by scrolling the up and down arrow keys. The selected charging option is invoked by pressing the INFO button, with ‘selected’ displayed. AUTO: Charging system determines optimum charge depending on charge and rate of discharge STANDARD: Charges at a p[prescribed rate, optimum for the charge. FAST: Accelerated charge, but provides less battery longevity REJUVINATE STANDARD: Discharge and recharge REJUVINATE FULL: Discharge and recharge twice Pressing the UNLOCK button will transfer the system into standby mode. Where a battery is completely flat, functionality can be resumed after approximately two hours of charging

Venturi System Service Manual Issue F

Page 17

3.5. Alarms: These comprise the following: Warning

Display / Sounder

System operation

Battery less than 5.95 Volts (system operates)

Low Battery / sounder

Continues with mains dc adapter. Mutable until warning re occurs

Battery disconnected or not fitted (system operates with mains dc adapter)

No Batt. / no sounder

Continues with mains dc adapter. Not mutable

Battery cannot be used because it is faulty ie: not taking any charge

O/C Batt / no sounder

system operates with mains dc adapter. Not mutable.

Charger is not working due to a PCB fault.

CCT Fail / no sounder

Loss of vacuum, when the counter value (section 3.2.4.) is exceeded System operation continues Instantaneous electromagnetic interference Open circuit pump

Fault: Low vacuum / sounder

System operates with mains dc adapter. One or more of the contacts on the battery module is not contacting the pcb. Not mutable. System operates. Alarm must be muted, even when fault is rectified.

Short Circuit pump

PUMP SHORT

Battery over-voltage

Fault: Battery . No sounder

Release Key

Displayed continuously

EMI / sounder PUMP OPEN

system operates. Mutable Fault in pump electrical connection. System will not function. Not mutable Fault in pump electrical connection. System will not function. Not mutable. System will not function. Not mutable. Stuck key. Not mutable

Venturi System Service Manual Issue F

Page 18

3.6. Battery replacement Remove canister if it is fitted, and ensure main dc adapter is disconnected. Unfasten the M4 coutersunk screw to remove the battery cover.

Remove cover. The battery will now be free to drop out. On replacement, the battery module can only be re inserted in one orientation. Ensure that no conductive materials are allowed to bridge the contacts on the battery module (eg: silver foil in a pocket)

Venturi System Service Manual Issue F

Page 19

3.7. Service Engineer Diagnostics. 3.7.1. Basic start up test for vacuum regulation: Connect a 3mm I/D x 1500mm tube and canister connection to the unit, and attach a SD500 tester at the other end. Put the unit into run mode at default 80mmHg. After a few seconds, the vacuum in the canister should be taken up. The pump should then demand once every few seconds, with the gauge showing between 70 and 90mmHg. Increase the set vacuum to 120mm and check the gauge achieves between 110 to 130mmHg 3.7.2. Low vacuum warning function Remove the gauge, and allow the unit to continue running. After 1 minute, a low vacuum warning should be issued (display and tone). Press mute to reset. Symptom

Cause

Low vacuum warning

If system is on a patient, pinch the drain tube and see if regulation returns. If so, dressing is leaking. (Observe infection control procedures) Check O ring on back of canister Check connection of sensor tube inside the unit., particularly on the pcb. Check pump tube attached, and not kinked. Replace and re test Check that Pump test frequency is > 22 (see section 4.5) 4.14.2.

System regulating ok, but not vacuuming on the drain line.

Constriction in the drain line – change the tube and re run. Kinked tube in the tube to the pump. Replace and re test

O/C Batt

Fault on battery module pcb. Replace the module.

CCT Fail

Lack of contact between battery and pcb. Replace battery module.

Calibration error

System needs calibrating. See section 4.1.

Release Key

Displayed continuously - Stuck key.

Venturi System Service Manual Issue F

3.8.

Page 20

Confirmatory test for service engineers.

This test ensures the system with its canister is a) functioning correctly b) that required pump performance is being achieved, and c) that there are no leaks. 3.8.1. Pump peak performance

Attach a canister to the unit. Insert a check valve with a load and SD500 digital read out Attach mains power supply. Switch off unit Plug in power supply Press the lock button and hold down Press start button then release start button still holding down lock button Keep holding button until beep has started and finished Charge will be displayed Press start button once (test cal should be seen) Press Up arrow until test pump is displayed Press (i) button Scroll up frequency counter to read 22 Press (i) button Press up arrow until PREG is displayed Press (i) button Press Up arrow to read 160mmHg (130mmHg is the minimum allowable) (Record the max reading ) Return setting to 120mmHg Press (i) button Press lock button to exit to standby mode.