AVIDIA Preventive Maintenance Procedure Oct 2008

Avidia Preventive Maintenance Procedure

REF: SM010016-01

CONTENTS 1

PURPOSE ... 3

2

RESPONSIBILITIES ... 3

3

EQUIPMENT ... 3

4

REFERENCES ... 3

5

GENERAL INSPECTION ... 4

5.1

Pedestal... 4

5.2

Injector Head... 4

5.3

Functional Checks... 5

6

PERFORMANCE VERIFICATION... 7

6.1

Delivered Volume and Flow Rate Accuracy ... 7

6.2

Over Pressure & Flow Reduced Function... 8

6.3

Motor Calibration... 9

6.4 6.4.1 6.4.2

Pusher Limit Switches ... 10 Rear Limit Switch... 10 Forward Limit Switch ... 10

6.5

Slop ... 11

6.6

Zero ... 12

7

ELECTRICAL SAFETY... 13

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

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Avidia Preventive Maintenance Procedure

1

REF: SM010016-01

Purpose

This document contains the steps required to complete a preventative maintenance schedule on an Avidia injector system. Section 6, Performance Verification in this procedure should be completed following Avidia repairs, which have resulted in software or hardware changes to the system. Any hardware changes to the Power Drawer will require Section 7 Electrical Safety be completed in addition.

2

Responsibilities

This Preventative Maintenance procedure is to be performed by Imaxeon and Medrad trained Field Representatives and Dealer Representatives.

3

Equipment •

General Hand Tools (Metric Allen Keys, Philips and flat-balde screwdrivers)

•

Leakage Test Box (Bender Leakage Tester)

•

Digital Pressure Gauge Assembly (Medrad 89301-00-AM-02 or Omega Digital Pressure Gauge STI PG-5000 & Parker Restriction Valve 9F200B)

•

Measuring Cylinder

•

Avidia test syringe

4

References [1] [2]

SM010001 SM010002

Avidia Service Manual Avidia Setup & Calibration Procedure

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

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Avidia Preventive Maintenance Procedure

5

General Inspection

5.1

Pedestal

REF: SM010016-01

1) Ensure castors roll freely and locking mechanisms are working correctly. 2) Inspect the power drawer and power cord for damage. 3) Raise the centre base cover and inspect cover seals remain effective against contrast media ingress. 4) Ensure the pedestal remains securely fastened to the base tub by checking the two M5 wedge bolts. 5) Inspect the arm, arm hinge, head bracket and bridge for fatigue cracking or any indication of wear. 6) Ensure all arm and head pivots move freely with some resistance to rotation. 7) Inspect the battery pack for any signs of damage or leakage. 8) Inspect hand / foot switch and interface cables (if connected), for cuts or exposed wires. 9) Inspect the syringe heat maintainer for cuts and worn areas. 10) Inspect the small monitor cable for cuts or exposed wires. 11) Inspect small monitor and bracket for cracks or damage. 12) Ensure the small monitor bracket pivots freely.

5.2

Injector Head

1) Inspect the pressure jacket. Replace if cracked, crazed or cloudy. Ensure the fluid dot strip and retaining springs are both installed. 2) Inspect head for excessive dried contrast media. If required, remove and clean injector head rear bezel and both upper and lower covers. Check sealing integrity of all bezel and cover gaskets and replace the complete gasket set if any contrast media is visible inside the injector head. 3) Inspect injector head front for wear or damage. 4) Inspect the injector head cable for cuts or exposed wires. Ensure injector head cable retainer clips on pedestal arm are fitted and not damaged. 5) Inspect the touch screen for wear or damage.

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

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Avidia Preventive Maintenance Procedure

5.3

REF: SM010016-01

Functional Checks

1) Touch and hold the centre of the Injector head touch screen while applying power. This will access the touch screen calibration. Touch and drag your finger to all areas of both the small monitor (if fitted) and injector head monitor, except CALIBRATE. A white mark will indicate a touch. If required, calibrate the screen. Press QUIT to exit this screen. 2) If the system is supplied with a syringe heat maintainer, perform the following steps. Access the OPTIONS menu and confirm that the HEATER option is ON, press QUIT and then LOCK so the piston advances until it engages the syringe plunger. Confirm the following: a) With the heat maintainer fitted the indicators are orange. b) The fault indicator is not on and the heat maintainer becomes warm. c) With heat maintainer fitted, syringe not engaged the indicators are yellow. d) With no heat maintainer fitted the indicators are white (as shown below).

Heat Maintainer Indicators

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

Page 5 of 13

Avidia Preventive Maintenance Procedure

REF: SM010016-01

3) Enter Service Mode (8845) and then press QUIT to return to the user Manual Fill screen shown below. The battery icon will now display battery voltage, which should be between 24 and 26Vdc normally and no less than 23.0Vdc if the Avidia has been on charge prior to this check. Connect mains power and the power cord symbol should now display. The battery voltage should start to increase slowly to 28 or 29.0Vdc for a fully charged battery. Do not continue further with Performance Verification if the battery is less than 24.0Vdc while battery is on charge.

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

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Avidia Preventive Maintenance Procedure

6

REF: SM010016-01

Performance Verification

Failure to meet performance requirements detailed in this section indicates the Avidia may need to be calibrated as per Avidia Setup & Calibration Procedure SM010002.

6.1

Delivered Volume and Flow Rate Accuracy

Install a new syringe and fill with water. Attach the pressure gauge assembly to the syringe. Fill the syringe with water and purge all air. Enter the following parameters: Flow rate = 10ml/s Volume = 100ml Rise/fall time = 0.1s Pressure = 1200psi. If available, connect a small diameter line as shown to the outlet of the restriction valve to improve measurement accuracy. Purge the syringe through the line until 120ml volume remaining is displayed on the screen. This will ensure the line is fully purged of air in order for the measured expelled volume to be accurate.

Delivered volume Volume remaining

Injection Duration

ARM the injector and tilt the head to the down position. Hold the line directly over the measuring cylinder so that all water expelled will be collected and measured accurately. Partially close the restriction valve. Press and hold the inject switch while monitoring the indicated pressure. Adjust the restriction valve to achieve a pressure of approximately 500PSI. The following shall be met: The amount of water collected in the measuring cylinder

100ml ± 2ml.

The delivered volume displayed on the touch screen

100ml ± 2ml

The volume remaining, indicated on the touch screen shall be

20 ± 2ml

The Duration time displayed on the touch screen shall be

10.1 ± 0.5s

The indicated pressure (not Peak Pressure) on the touch screen during the injection shall be within

± 50psi of the pressure gauge

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

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Avidia Preventive Maintenance Procedure

6.2

REF: SM010016-01

Over Pressure & Flow Reduced Function

1) Refill the syringe with water and purge all air. 2) Enter the following parameters. Flow Rate = 40ml/s Volume = 100ml, Rise/fall time = 0.4, Pressure = 1200psi. Adjust the variable restrictor to a near closed position in order to cause the injector to reach an over pressure state (simulating a blocked line). This occurs when the pressure rises very quickly and stops the injection.

Read ahead before performing the next injection. Open the variable restrictor. During the injection, adjust the variable restrictor carefully to cause the injector into pressure limiting or Flow Reduced mode. Failure to achieve the Flow Reduced pressure of 1050 ± 50psi could indicate inaccuracy in pressure calibration. In that case, repeat this test a number of times before referring to Avidia Setup & Calibration Procedure SM010002. 3) ARM and INJECT 4) The injector shall be forced into pressure limiting. This can be identified by the message Flow Reduced, which appears on the screen as shown 5) During the injection, the indicated Pressure on the screen shall peak (but not exceed the 1200psi limit) and then stabilize at 1050 ± 50psi

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

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Avidia Preventive Maintenance Procedure

6.3

REF: SM010016-01

Motor Calibration

Checking motor calibration is in reality checking the fundamental operation of the head itself. Errors of any kind are likely to manifest themselves as incorrect flow rate and volume and abnormal power requirements. This is an absolute test for motor calibration and any calibration, motor or motor drive issue will display something different to that shown for one or all three of the waveforms. Verify correct motor calibration by the following visual test. Enter SERVICE MODE and then select Hall Error , set flow to 0.1ml/s and press RUN , the motor will run very slowly forward. Press TYPE to change the display to SENSORS mode and you will see 3 coloured sine waves. All three waveforms should be smooth, identical and with no distortion.

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

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Avidia Preventive Maintenance Procedure

6.4

REF: SM010016-01

Pusher Limit Switches

The two pusher limit switches ensure power is removed from the motor should pusher travel exceed the normal range. In normal operation, the limit switches are not activated and their sole purpose is to prevent pusher overrun

6.4.1

Rear Limit Switch

1) Press UNLOCK. 2) The pusher will stop at the most the rearward point of normal travel. 3) Using the manual knob, rotate clockwise no more than ½ turn past the UNLOCK position, the Avidia should alarm and display the screen below.

6.4.2

Forward Limit Switch

1) Without a syringe installed, press LOCK. 2) The pusher will stop at the most forward point of normal travel, where the contents of the syringe would be fully expelled (0ml). 3) Using the manual knob, rotate counter clockwise no more than ½ turn past the 0ml position, the Avidia should alarm and display the screen below.

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

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Avidia Preventive Maintenance Procedure

6.5

REF: SM010016-01

Slop

SLOP is the term used for the internal travel within the pusher, required to correctly engage and release the syringe plunger during syringe filling. Incorrect SLOP adjustment will either fail to grab the syringe plunger (lock pins not extending fully) during filling or not release the syringe plunger (lock pins not retracting fully) during the UNLOCK process.

How to test for correct SLOP adjustment is as follows. With the pressure jacket and syringe removed, select Manual Fill and move the pusher well forward so the tip of the pusher can be visualised easily as shown. Now retract the pusher for a moment, stop and observe the pusher tip as the slop or internal travel is taken up. What you should see if correctly adjusted is the 6 lock pins fully retracting, without the pusher moving. If the internal travel is too little, the 6 lock pins will not fully retract or if too much the 6 lock pins will fully retract followed by a small forward movement of the pusher.

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

Page 11 of 13

Avidia Preventive Maintenance Procedure

6.6

REF: SM010016-01

Zero

The ZERO adjustment ensures that the syringe plunger in the 150ml position is in correct alignment with the fixed front housing. Incorrect ZERO adjustment can result in damage to the syringe plunger, which can in turn make it difficult to open the front housing. With the pressure jacket and syringe removed from the previous test, perform both AUTO FILL and MANUAL FILL to 150ml volume. At this position, using your finger to check that the surface of the pusher’s front face is level, or slightly proud (forward) of the black insert in the fixed front housing.

Front housing black insert

Surfaces to be level

Pusher front

6.7

Syringe Sensor

The syringe sensor is an infrared device mounted in the front of the pusher to detect the presence of a syringe or more correctly a syringe plunger. The function of the syringe sensor is correct when the pusher can successfully lock and unlock to the syringe plunger.

To confirm correct operation, install a syringe and using Manual Fill move the syringe plunger forward into view as shown. Press UNLOCK and ensure the unlock process is completed fully without error. Now press LOCK and observe the pusher moving forward. When close to the syringe plunger, the pusher will slow and then stop without actually touching the syringe plunger. This confirms correct syringe sensor function. .

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

Page 12 of 13

Avidia Preventive Maintenance Procedure

7

REF: SM010016-01

Electrical Safety

This procedure should be completed annually as part of the PMP, or if any item in series from the power cord to the power supply (Power Drawer). If using commercially available test equipment (Bender box), follow the appropriate instructions provided. a) b)

Remove the detachable power cord. Measure the resistance of the detachable power cord earth conductor. The resistance shall be less than 0.2 Ω. Measure the protective earth resistance from the power inlet to the earth stud on the power drawer. The resistance must be less than 0.1 Ω.

c) Carry out the insulation resistance from short-circuited active and neutral pins of main plug to the protective earth pin of the power plug (1) The measured value shall be greater than 1MΩ. d) Carry out insulation resistance from short-circuited active and neutral pins of main plug to the exposed conductive parts of the Injector (2). The measured value shall be greater than 1MΩ. e) Carry out earth leakage current tests in both normal condition and single fault condition (neutral open). The earth leakage current shall be less than the following values. i) Normal Condition: 500µA ii) Single Fault Condition: 1.0mA

Hardcopy effective until 14-Oct-08 unless stamped Controlled Copy

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