Service Manual
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service manual
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REFSM010001-05
Avidia Service Manual
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CONTENTS 1
INTRODUCTION... 5
1.1
Patient Safety ... 5
1.2
Installation ... 6
1.3
Upgrades and Modifications... 6
1.4 1.4.1
Manufacturer’s Warranty... 6 Replacement Parts Warranty ... 6
2
REFERENCES... 6
3
PRODUCT DESCRIPTION... 7
3.1 3.1.1 3.1.2 3.1.3 3.1.3.1 3.1.3.2 3.1.3.3 3.1.3.4 3.1.4
Injector Head ... 7 Syringe Interface... 7 Mechanical Drive System ... 7 Electronic Control System ... 7 Control Board ... 7 Motor Drive Board ... 7 Back Board ... 8 Position Sensor Boards ... 8 LCD Touch screen... 8
3.2 3.2.1 3.2.2 3.2.3
Pedestal and Base Assembly ... 8 Base Board ... 8 Power Drawer ... 8 Battery Pack ... 8
3.3
Small Monitor ... 9
4
PRODUCT SUPPORT ... 10
4.1
Certification ... 10
4.2
Avidia Support Training ... 10
4.3
Service Flow Chart... 11
5
COMPONENTS FOR REPLACEMENT ... 12
5.1
Support in a Case ... 12
5.2 5.2.1 5.2.2
Field Replaceable Units... 12 Mechanical... 12 Electronics ... 13
6
FIELD SERVICING ... 14
6.1
SIAC Replacement Decision Tree ... 14
6.2
Disassembly ... 14
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6.2.1 6.2.2 6.2.3 6.2.3.1 6.2.4 6.2.5 6.2.6
Injector Head Removal ... 15 Battery Pack Removal ... 16 Base Unit Disassembly... 17 Base PCB Cables Disconnection ... 18 Power Inlet Assembly Removal... 19 Pedestal Disassembly ... 20 Injector Head and Small Monitor Cable Removal ... 22
6.3 6.3.1.1
Reassembly ... 24 Base PCB reassembly... 24
6.4 6.4.1 6.4.2 6.4.3 6.4.4
Base Assembly Tests ... 25 Base power supply and charger test ... 25 Basic system test - low power ... 25 Basic system test - high power... 26 System Reassembly ... 27
7
MAINTENANCE PROCEDURE ... 28
7.1
Scope ... 28
7.2
Equipment... 28
7.3
Documentation ... 28
7.4
Maintenance Procedure Guide ... 28
7.5 7.5.1 7.5.2 7.5.3
General Inspection... 29 Base Inspection ... 29 Options and accessories ... 29 Injector Head ... 29
7.6
Functional Checks ... 30
7.7 7.7.1 7.7.2 7.7.3
Performance Verification ... 33 Delivered Volume and Flow Rate Accuracy ... 33 Calculated Pressure Accuracy ... 34 Electrical Safety ... 35
7.8
Functional Verification Test Result Form... 35
7.9
Calibration ... 35
8
APPENDIX – ERROR CODES... 36
9
APPENDIX – SYSTEM BLOCK DIAGRAMS ... 39
10
IMAXEON CONTACT INFORMATION ... 43
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©2005, Imaxeon Pty Ltd. All rights reserved. Reproduction of this operation manual is strictly prohibited without express written consent of Imaxeon Pty Ltd. For more information about Imaxeon products and services, please visit www.imaxeon.com
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Avidia Service Manual
1
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Introduction The Avidia Angiographic Contrast Injector used in conjunction with the 150-EF-Q syringe is designed to deliver X-ray contrast media, in a controlled and safe manner, taking into account variations that occur in the injection path. X-ray contrast media is injected into the venous or arterial system of patients undergoing X-ray examination, to enhance the display of blood vessels and certain organ functions. As the contrast is diluted, absorbed and excreted by the body in a matter of minutes, coordinating the injection with start of scanning – to take full advantage of the enhancement, becomes critical. Contrast viscosity reduces when it is warmed, which becomes a factor for patient comfort and the amount of pressure needed to deliver the required flow rate. The Avidia Angiographic Contrast Injector is a new generation product relying on extensive use of microprocessor technology and consequently the system requires very little in the way of external adjustments for calibration. In addition, minimal test equipment is required for system verification and calibration. Due to the surface mount technology used, the electronic printed circuit boards (PCBs) are considered non-repairable and should be replaced rather than repairs attempted. Field replacement units are limited to major assemblies, all of which are contained in Support in a Case (SIAC). Refer to Section 4, Product Support. Avidia Report Software allows monitoring and control of the injector from a host computer and the downloading of calibration data from the system for certification purposes.
CAUTION: Avidia service must only be performed by Imaxeon authorized service personnel. The information in this manual is COPYRIGHT protected and must not be copied or redistributed without the express permission of Imaxeon
1.1
Patient Safety Contrast media is electrically conductive and when injected compromises the patient’s epidermal insulation - hence some extra precautions are necessary. Battery operation significantly increases the electrical safety for the patient and it is recommended the AVIDIA be disconnected from line power whenever possible, in particular when injecting. The AVIDIA requires a protective earth connection (electrical grounding) from line power as per the requirements of IEC60601-1. If the integrity of the earth connection cannot be verified, as a precaution instruct the operator to disconnect mains power before attempting a patient injection. The same precaution applies to the use of alternative power cords and extension cords. Any computer equipment connected to the communication port must be disconnected and removed from the patient area unless compliance to IEC60601-11 can be verified. The AVIDIA is not completely liquid proof and in the unlikely event of fluid spilling onto the unit, disconnect line power immediately. Clean up with a damp cloth. If it is suspected fluid may have entered the AVIDIA, do not re-connect line power until the system has been checked thoroughly inside. Fuse failures, should only be replaced with the same type and rating as specified. As with most electrical equipment, the AVIDIA is not suitable for operation in the presence of flammable anaesthetics.
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WARNING The AVIDIA may malfunction or fail to operate when exposed to high magnetic fields. Do not use radio transmitters, mobile phones or devices generating electrostatic discharge in the vicinity of the injector. Under no circumstances, should the AVIDIA be used within the MRI suite as ferrous metals have been used in the construction of the injector.
1.2
Installation No installation is required. However, following assembly, Section 7, Maintenance Procedure, of this manual should be completed before use. Familiarization with the Avidia system and the Operation Manual is recommended before attempting any service procedures contained in this manual.
1.3
Upgrades and Modifications As the Avidia design evolves, various hardware and software improvements will be developed. Authorized service personnel will have access to Imaxeon Service Bulletins and Instructions explaining these improvements in detail. Where increased performance or additional features are part of the improvement, this would in most cases be a chargeable option. Refer to Imaxeon Customer Service for more information.
1.4
Manufacturer’s Warranty The Avidia system is guaranteed against defects in materials or workmanship occurring under normal use and due care for a period of twelve (12) months from the factory ship date. Should a fault occur, the system would need to be returned to Imaxeon or an authorized Imaxeon Service Agent, where all parts and labour will be free of charge for the warranty period. Freight costs are not included and the original carton should be retained to ensure the system is not damaged during transport. Travel and on site labour are an additional charge. Be aware, unauthorized service could void the warranty.
1.4.1 Replacement Parts Warranty Replacement parts are guaranteed against defects in materials or workmanship occurring under normal replacement use for a period of ninety (90) day from the factory ship date.
2
References [1] [2] [3]
MN010001 FM000022 SM010002
Operation Manual Avidia Form Avidia Field Replacement Avidia Calibration Manual
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Product Description The Avidia Angiographic Contrast Injector is capable of injecting 150ml maximum volume at pressures up to 1200 psi and flow rates up to 50 ml/sec. The system consists of three main components – 1. Injector Head (Section 3.1) 2. Pedestal and Base Assembly (Section 3.2) 3. Small Monitor (Section 3.3)
3.1
Injector Head The injector head contains the syringe interface, mechanical drive system and control electronics. A single cable connects the injector head to the base assembly.
3.1.1 Syringe Interface The interface for the Avidia 150-EF-Q syringe comprises three main components, a pivoting front plate supporting the pressure jacket, a fixed high strength mating part and the syringe drive piston. The drive piston is controlled by the mechanical drive and electronic control systems.
3.1.2 Mechanical Drive System A 24VDC brushless, 200W motor with an integral 23:1 reduction gearbox provides mechanical drive. The motor has low inertia for fast response to pulse width modulated speed control used in this application. At the rear of the motor is mounted a 3 phase analogue encoder, providing a three phase output waveform in direct relation to the motor rotation. Using the microprocessor internal A/D converters, the waveform is resolved to give 1500 position counts per revolution. From the gearbox, there is a 1:1 gear drive to the ball screw. The ball screw is a precision threaded shaft, providing efficient and linear drive to the syringe plunger. In total, there are 34,500 counts for every revolution of the ball screw, or approximately 6,900 counts for 1mm of travel of the syringe plunger. For added safety, ball screw rotations are sensed independent of the motor by a sensor mounted on the end of the ball screw. This is called the Final Drive Encoder (FDE) and provides the reference for the motor counts (1:34,500).
3.1.3 Electronic Control System The control system consists of a number of major assemblies, which can of course be broken up into sub-assemblies. The intention of this manual is to give enough information for field replacement of major assemblies only. The sub-assemblies are not considered field replaceable and require completion of the calibration procedure, which can only be completed by authorized service personnel. However, for clarity of function, sub-assemblies are referenced below.
3.1.3.1 Control Board The control board microprocessor directly controls the motor, touch screen, colour display and communicates with the small monitor display and serial port. The microprocessor provides 3-phase PWM signals for the motor drive. This control board consists of a microprocessor, flash memory and RAM and LCD controller.
3.1.3.2 Motor Drive Board The motor drive board takes the motor control signals from the control board and drives high power FETs that supply power to the motor. This board also has circuits for the syringe heat maintainer and the front lock solenoid. Motor current is measured on this board and this information is fed back to the control board.
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3.1.3.3 Back Board The Back Board has 40 dual colour LEDs for visual indication. It also has an audio amplifier for the speaker, the interface circuitry for the FDE sensor and two service connectors. The FDE interface has two purposes: •
Cross check for syringe position, which equates to syringe volume.
•
Detect any mechanical slippage or failure in the drive system by comparing to the microprocessor encoder output.
3.1.3.4 Position Sensor Boards The position sensor board has the following functions: •
Ballscrew Limit Switches – one lever switch at each extremity of travel. Activation of either switch halts the motor immediately.
•
Start Position Sensor – optical sensor, which activates at full retraction and sets the maximum permitted travel position, defined as the start position. The defined start position is the reference for all positions (syringe volume) of the syringe piston.
•
Syringe Sensor – senses the reflection of a modulated infrared waveform from the rear surface of the syringe plunger. As the piston drives towards the syringe plunger the sensor detects the reflected waveform from the plunger. The waveform amplitude increases, peaks and then decreases with proximity. This is the signal to halt forward movement of the piston.
3.1.4 LCD Touch screen The LCD is a STN type display of 640 x 240 resolution fitted with an integral resistive touch screen as a complete assembly. There is a separate module for the backlight.
3.2
Pedestal and Base Assembly
3.2.1 Base Board The base board essentially controls the power switching of the battery pack and directs either 24 VDC or 48 VDC to the power head as required by the selected flow rates of the injector. The base board includes the battery chargers, and the ISI interface. Communications between the various modules is routed via the base board using balanced RS422.
3.2.2 Power Drawer The power drawer contains the battery pack circuit breakers, ISI interface connector, equipotential point and mains/line power supply. The power supply automatically detects the line/mains input supply voltage and self-adjusts. The IEC inlet connector/switch unit contains the main fuses.
3.2.3 Battery Pack The battery pack houses four 12V, 7AHr, lead acid batteries. The battery pack provides the power requirements during the injections. For flow rates up to 20ml/s two batteries are connected in series, giving 24V. For flow rates above 20ml/s all four batteries are connected in series to provide 48V. The internal wiring of the pack brings out the battery terminals on one connector and the series connections onto a separate connector for the in line circuit breakers. This ensures that the battery packs cannot be shorted easily and are therefore safe to remove and store.
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3.3
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Small Monitor The small monitor, mounted on the pedestal, provides control of the injector to another operator and also provides a secondary START switch. The small monitor is a reduced functionality version of the control board, and uses the same processor, memory, and LCD controller. The small monitor communicates with the control board via an RS422 balanced data link for minimal noise and maximum immunity to interference. Functional control of the injector is possible from either the injector head or the small monitor.
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Product Support Avidia support is based on a strategy called Support in a Case (SIAC). This is a full compliment of certified Avidia spare parts in a transportable container. The parts have been certified as a complete working system. When used as individual parts, certification is transferred with that individual part provided minimum system functional checks are then successfully completed. Used in the manner intended, SIAC offers several advantages, the most significant being the low level training required by service personnel to deliver a relatively high level of product support and patient safety in a timely manner. Without certification, SIAC retains its value as a convenient source of spare parts. However, installing an uncertified part into a system, requires completion of full system calibration before being used with patients. Full system calibration can only be completed by authorized personnel and cannot avoid adding to the system downtime.
4.1
Certification Service personnel, who have successfully completed Avidia Support Training, are authorized to carry out calibration of the Avidia system. Avidia Support Training provides the following mandatory items used in the calibration procedure. •
Service Report Card Software.
•
Pressure Transducer Interface.
• Electrical Safety Tester The purpose of the Service Report Card Software is to download the diagnostic data from the system and format that data into a report card. When the Service Report Card is signed and dated by authorized service personnel, certification is complete. An authorized Service Report Card must be included with the SIAC to use as intended, effectively eliminating the need to certify systems on-site. The pressure transducer interface provides a direct comparison between actual syringe pressure and calculated pressure derived from motor current. The data from the interface is fed back into the system and any differences between the measured and the derived pressures are corrected for as part of the system diagnostics. By using the system’s battery pack as a high current power source for the Electrical Safety Tester, provides for a level of testing than would normally not be available in the field. This translates to a higher level of patient safety, which is most significant when operating in a cardiac environment. Certification remains valid for 12 months, provided the contents of the Support in a Case have not been used in part or whole within that time.
4.2
Avidia Support Training There are two levels of Avidia Support Training depending on the strategy adopted: 1. Comprehensive high-level training covers all aspects of system repair and authorizes system certification. No less than one (1) person per country or region should be trained to this level and they need to be prepared to support other service personnel in the country or region. High-level training is a two (2) day course and includes the test items mentioned in CERTIFICATION above. 2. When adopting the SIAC strategy, significantly lower level training is sufficient. This can of course, be delivered by the service personnel who have received the high-level training above. Allow four (4) hours for this course.
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Avidia Service Manual
4.3
Service Flow Chart Below is a summary of a typical process flow for servicing of the Avidia system for a Support in a Case (SIAC) and a customer Avidia system (Av). System requiring repair
Field Replaceable Units
Certified SIAC
System Maintenance Procedure
System Maintenance Procedure
F
P
F
P
F
System Calibration Procedure
P
System maintenance procedure: •
remains valid for 12 months
•
maintains existing warranty/certification
•
discounts spare parts by 50%
System calibration procedure: •
Requires authorised personnel
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Avidia Service Manual
5
Components for Replacement The following components or assemblies are available:
5.1
5.2
Support in a Case Component/Assembly
Catalogue Number
Support in a Case (all components below)
AV SIAC
Injector Head
AV 001S
Small Monitor
AV 013S
Base Board
PA 0200S
Power Drawer
AV 010S
Cable Set
WCAS002S, WCAS015S
Field Replaceable Units
5.2.1 Mechanical Component/Assembly
Catalogue Number
Injector head cover upper
MO0014
Injector head cover lower
MO0015
Base cover
VAC003
Power draw cover
VAC004
Castor lock
HC0007
Castor no-lock
HC0006
Manual knob
AV002
Injector head front
AV0031, AV0032, AVFLS
Injector head drive system
AV0004S
Screw injector head attach
MAM09
Handswitch
AV015
Footswitch
AV014
Pressure jacket
AV020
Heat maintainer
AV012
Power cord (Australia, Europe)
WP0004, WP0016
Rear lens
MO001
Injector head gasket set
HV0005, HV0006, HV0008, HV0012, HV0013
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Avidia Service Manual
5.2.2 Electronics Component/Assembly
Catalogue Number
Small monitor
AV013S
Head display / bezel
GD0005, GD0006, MO004, HU0012, HU0003
Position board
PA0203S
Head control board
PA0204S
Motor drive board
PA0202S
Back board
PA0201S
Motor / gearbox
AVBMSA
Base board
PA0200S
Power draw
AV 010S
Cable injector head
WCAS002
Cable small monitor
WCAS015
Battery pack
HB0020S
Pusher solenoid board
AVSBAS
Syringe sensor cable
WCAS011S
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Avidia Service Manual
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Field Servicing When a customer Avidia system is found to be faulty, following the SIAC procedure provides a high level of efficiency and patient safety. Modules from the SIAC are calibrated, so can be readily used as replacement parts for the faulty customer system. The following sections describe the assembly and disassembly procedure for the Avidia. Refer to Section 6.1 to decide which module should be replaced.
6.1
SIAC Replacement Decision Tree Refer to Appendix – Error Codes System error reporting is comprehensive and in most cases indicates the origin of the fault. Should there be any doubt, then SIAC can conveniently be used to eliminate rather than pinpoint the source of the problem. The injector head, small monitor and the cable set can all be substituted easily and thus eliminated as the source of the problem. Both the base board and the power draw will need to be exchanged, as there is no easy way of having them operational when external to the system.
6.2
Disassembly Major assemblies used in the Avidia are heavy, and care should be exercised when removing securing screws. Tools required for disassembly are – 1x
Hex Allen key 6mm
1x
Hex Allen key 4.5mm
1x
Hex Allen key 4mm
1x
Hex Allen key 1.5mm
1x
Small Philips screwdriver (No.1)
1x
Large Philips screwdriver (No.2)
WARNING Before commencing any disassembly: 1. The mains cable is removed from the IEC socket and power is turned off. 2. Locate the two circuit breakers CB1/CB2 on the external connector panel. Pull each circuit breaker lever away from the unit until no more movement is felt. A white band should now be visible on each CB. The CBs are now deactivated. 3. Lock the base wheels to prevent movement of the system. 4. Adjust the head arm to a convenient angle to allow easy access to the head for removal.
CAUTION Do not remove the battery until the head and arm are locked into place in the storage position with the head located above the handle. The battery pack serves as ballast and the Avidia may tip over if the arm is extended with the battery pack removed.
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NOTE: The following instructions describe the COMPLETE DISASSEMBLY of the Avidia in an ordered sequence to allow easiest access to the components.
6.2.1 Injector Head Removal Caution: - Injector head is HEAVY
1. Remove the head cable by undoing the two captive screws on the connector. Pull the cable clear of the head.
2. Adjust the injector head so that it is horizontal. 3. Using a hex Allen key 6mm, carefully undo the 2 bolts located at each end of the connector socket under the head. The screws are captive in the arm assembly and will assist in locating the head during removal. Leave the screws in the positions as shown to aid in reassembly.
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4. Carefully grip the head from below and lift clear of the arm support. 5. Place head gently on a flat surface.
6.2.2 Battery Pack Removal 1. Lift the plastic dress cover from the base.
2. Secure with the support lever located across the battery box. The lever lifts to the vertical position to support the base dress cover.
3. Ensure that the battery packs are disconnected by the removal of both black power connectors from the pack. Each plug has a small lever, which must be operated to allow the removal of the plugs. Remove both plugs
4. Locate the four securing screws, two at each end of the pack. 5. Remove all four screws.
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6. Lift the battery pack out of the base unit, using the handle provided
Caution: - Battery pack is heavy, use care.
6.2.3 Base Unit Disassembly 1. Locate the head and small monitor cables connectors and undo the securing screws and remove each connector. Use caution, as the pins are delicate. Secure the cables to the pedestal upright.
2. Locate the single securing screw near the connector plate and remove. Note that the connector plate will remain attached to the base assembly; only the battery plate will become loose.
3. Remove the battery plate. Lift the plate from the end shown first. 4. Do not pull on the cables that pass through the plate from below.
5. The base board is now accessible. 6. Disconnect the cables from the base board following the procedure in Section 6.2.3.1.
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6.2.3.1 Base PCB Cables Disconnection 1. The cables connected to the base PCB are as follows. Note the connectors are distinct, to minimise the chances of mis-identification and connection
Conn
Type
Function
From
JP13
4W (3.96mm)
AC Charger connection
Power Drawer
JP11
14W IDC
ISI-1
Power Drawer
JP17
2W (5.0mm)
ISI-2
Power Drawer
JP7
3W (2.54mm)
Foot/Handswitch
Power Drawer
JP6i
10W IDC
Internal comms. (head/base)
Int Conn Panel
JP6
14W IDC
Internal control
Int Conn Panel
JP10
16W IDC
Internal comms. Head/small remote)
Int Conn Panel
JP14
2W (10mm)
High Power motor supply
Int Conn Panel
JP9
10W IDC
External Comms
Power Drawer
2. Disconnect cables except for JP14, which is the large black 2 pin connector centrally located. This connector can be removed after all securing screws are removed from the base PCB and the PCB can then be tilted at an angle to aid in the connector removal, alternately AFTER the power inlet assembly is removed.
JP6
JP6i
JP9
JP10
JP14
JP17
JP4
JP11
JP5
JP7
JP13
NOTE: The high power cables connected to JP4 and JP5 are permanently connected to the board. Hardcopy effective until 28-Apr-06 unless stamped Controlled Copy
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3. Unscrew the screw connecting the earth cables (three green/yellow cables and one black cable). 4. Lift the black cable clear.
5. Unscrew the 6 screws on the base board. 6. Lift the base board and disconnect JP14. Push on the black lever on the connector to release.
7. Lift the base board clear of the base.
6.2.4 Power Inlet Assembly Removal 1. Disconnect the yellow/green earth cables from the base by undoing the nut and separating the earth connections. 2. Locate the DC power cable (red/white) connected to the base PCB and ensure that the cable is disconnected. 3. Locate the ISI cable set connected to the base PCB and ensure the cables are disconnected. 4. Locate the heavy duty circuit breaker cables (black) and ensure that the cables are untangled. 5. Remove the rear power inlet assembly by undoing the two screws located under the rear dress cover.
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6. The power inlet assembly will drop away from the cut-out in the base. Gather the connecting cables and gently pull the assembly away from the base.
NOTE: The high power cable and 4W connector will also be removed with the assembly – these cables are part of the circuit breaker sub-assembly.
6.2.5 Pedestal Disassembly NOTE: It is possible to perform the removal of the battery pack (Section 6.2.2), base board (Section 6.2.3) and power inlet (Section 6.2.4) without removing the pedestal. However, the pedestal and bridge need to be disassembled before removing the injector head and small monitor cables. Caution: - The head arm and bridge handle unit are heavy.
The pedestal assembly consists of three parts: a. Head Arm b. Bridge Handle Unit c. Upright Pedestal 1. Disconnect the cable from the head arm by undoing the quick-connect ties located along the length of the inside surface of the arm. 2. Disconnect the cable from the bridge handle by undoing the quick connect ties.
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