Professional Documents
Culture Documents
Injector, Salient Service Manual PDF
Injector, Salient Service Manual PDF
Document Approvals
1 of 36
Service Manual
SM040001-18 Salient
Service Manual
Steve Carruthers, Chi Nguyen
Abstract: This document defines the service procedures for the Salient Contrast Injector.
CONTENTS
2 of 44
Salient Service Manual REF : SM040001-18
1 INTRODUCTION ............................................................................................................................. 5
3 of 44
Page 2 of 35
4 of 44
Salient Service Manual REF : SM040001-18
3.9 Serial No ................................................................................................................................... 19
5 of 44
Salient Service Manual REF : SM040001-18
Page 3 of 35
7.1.7 Touch Screen Controller ................................................................................................... 34 7.1.8
IR Decoder ........................................................................................................................ 34
6 of 44
Salient Service Manual REF : SM040001-18
Page 4 of 35
1 Introduction
1.1 Purpose
This document defines the service procedures for the Salient Contrast Injector.
1.2 Caution
Salient 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.
The Salient Contrast Injector, when used in conjunction with the ZY6320 syringe, is designed to deliver xray
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 system of patients undergoing CT and other X-ray
examinations, to enhance the display of blood vessels and certain organ functions. In most cases the
contrast has little effect on patients, however if injected incorrectly could be very dangerous and therefore
it is our responsibility to ensure the injection system is operating correctly at all times.
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 in patient comfort and the amount of pressure
required to deliver the appropriate flow rate.
Many elderly patients have vascular disease and their veins may not accommodate an injection of contrast
at high flow rates. Should the needle dislodge or the vein becomes damaged during the injection, contrast
will be forced into surrounding tissue and a painful injury called extravasation will result. The Salient has no
means of detecting extravasation and cannot prevent the resulting injury to the patient.
1.4 References
[1] MN040010 Salient Operation Manual English Single/Dual
[2] MN040008 Salient Unpacking and Installation Sheet
[3] EN60601-1: Ed 3.0 Medical Electrical Equipment, Part 1: General requirements for basic safety
and essential performance
[4] SM040008 Salient RCU Software Installation Procedure
7 of 44
Salient Service Manual REF : SM040001-18
[5] SM040018 Salient Annual Preventive Maintenance Procedure
[6] TN040002 Salient Product Updates
Page 5 of 35
1.5 Installation
Initial installation is quite simple and entails installing the injector head unit on to the pedestal. This process
is described in detail in [2], a copy of which is provided in the packaging of your Salient. The process is also
described in Section 3 of [1] and is repeated here for convenience:
2.
A B C D
4.
5. 6.
8 of 44
Salient Service Manual REF : SM040001-18
Following assembly, familiarization with the Salient system and the Operation Manual is recommended
before attempting verification of system function and performance.
Page 6 of 35
1.6 Initiating Warranty Period
The initial power up screen is shown below.
Press the Activate Warranty Now button and the date will be recorded in the system as the date of
installation for the warranty period. In 12 months time, an annual service reminder message will appear
briefly as a prompt to have the system checked by an authorized Imaxeon Service Agent.
9 of 44
Salient Service Manual REF : SM040001-18
Do not confuse the Salient system serial number with the head serial number as shown. The head serial
number includes the prefix S (for single) or D (for dual) head.
Page 7 of 35
2 Preventive Maintenance
2.1 Schedule
Frequency Procedure Reference
12 months Download system data log files (Salient Report) and Section 4.4.3
email to salient@imaxeon.com
Perform the following procedures on an annual basis as a preventative maintenance measure and as a
system check following repairs or replacement of assemblies. Failure to meet the requirements of the
Performance Verification section should be followed by completion of the Calibration Procedures in Section
3.
10 of 44
Salient Service Manual REF : SM040001-18
a) Plug in a heat maintainer and verify that it becomes warm to the touch and that the warning light
moulded into the body of the heat maintainer does not light up.
b) If the heat maintainer fails to warm up, swap out the head.
c) If the heat maintainer waning light is lit, replace the heat maintainer.
3) Battery and line power switching
a) With the Salient switched off on the head, plug a power lead into the base and attach to a mains
supply.
b) Ensure that the power switch on the base is in the “On” I position, and that the LED charging lamp
on the base is lit.
Page 8 of 35
11 of 44
Salient Service Manual REF : SM040001-18
c) Ensure that the connection remains established by monitoring the wireless icon on the RCU.
Page 9 of 35
6) ARM the Salient and tilt the head to the down position.
7) Partially close the restriction valve.
8) Press the inject switch on the screen or the remote control to start the injection.
9) While monitoring the indicated pressure on the gauge, adjust the restriction valve to achieve a pressure
of approximately 100psi.
The following conditions shall be met:
The delivered contrast volume displayed on the screen (can be verified 100ml ± 2ml
against a measuring cylinder when available)
The actual duration time displayed on the screen (can be verified against 20 ± 0.5s
a stop watch when available)
The indicated pressure displayed on the screen during the injection shall ± 50psi of the pressure gauge
be within reading during the injection
12 of 44
Salient Service Manual REF : SM040001-18
Page 10 of 35
Plunger
Sensor
To confirm correct alignment, retract the piston fully and install a new syringe with the fill screen displayed.
Press the engage button, the injector should detect the new syringe and automatically purge the syringe of
air. When fully purged, check the position of the syringe plunger is at the 0ml position. There should be no
remaining volume, nor should the syringe plunger be pushed hard against the end of the syringe barrel.
This confirms correct plunger sensor and zero volume position alignment. Note the automatic purge feature
is disabled when systems are configured for pre-filled syringe adapters.
Refer to both 3.5 Zero Volume Calibration and 3.7 Plunger Detect Threshold should there be any issues
detecting a new syringe and purging to the zero volume position.
13 of 44
Salient Service Manual REF : SM040001-18
5) Earth leakage current in normal condition shall be less than 500µA.
6) Earth leakage current in single fault condition (neutral open) shall be less than 1.0mA.
Page 11 of 35
14 of 44
Salient Service Manual REF : SM040001-18
3 Calibration Procedures
3.1 Equipment Required
Pressure Gauge & Valve Assembly (Omega Digital Pressure Gauge STI PG-5000 & Parker Restriction
Valve F200B or equivalent) WCAS079 Output Cable
3.2 Preparation
1) To remove the lower enclosure cover of the injector head first remove the six screws shown.
Page 12 of 35
15 of 44
Salient Service Manual REF : SM040001-18
Current position
values
Save button
Back to menu
1) Select the motor (Left or Right) by pressing on the button labelled Select:
2) Locate the plastic gear wheel at the back of the motor to be calibrated.
3) With your fingers, rotate the gear wheel back and forth so that the MIN and MAX values change. Keep
rotating back and forth until the MIN and MAX values no longer change.
4) Press the save button to store the new motor calibration. The save icon will change to a yellow colour
when the values have been saved.
5) Press the <<button to return to the Service menu.
6) If the << button is pressed before pressing the save button, any calibration changes will be discarded.
Page 13 of 35
16 of 44
Salient Service Manual REF : SM040001-18
Leave as Cal: ON
(ON = no PID, Graph of Hall
OFF = PID engaged) sensor readings
NOTE: If in the home position (full retracted) the piston will not move inwards (In direction). Change the
piston direction by pressing the In button so that it displays Out, now pressing the START button will move
the piston slowly outwards.
During Motor Calibration or anytime the motors are manually rotated, the actual piston position can be lost.
This is not an issue provided the piston is fully retracted to reset piston position. Therefore, after completing
Motor and Hall Offset Calibration, press retract before proceeding further.
17 of 44
Salient Service Manual REF : SM040001-18
Page 14 of 35
3.5 Zero Volume Calibration
18 of 44
Salient Service Manual REF : SM040001-18
Page 15 of 35
When pre-filled syringe adapters are used, the adapters and therefore the contrast are uniquely configured
for the right hand side of the injector head. The Zero Volume Calibration on the saline side uses a normal
syringe and follows the procedure described previously.
To complete Zero Volume Calibration for both Prefilled Syringe Adapters, you will need the DC030 (100ml)
and DC029 (150ml) adapters plus empty 100 and 150ml syringes. The empty syringes need to be the same
syringe type or brand being used by the customer for the most accurate Zero Volume Calibration. This is
due to the variations in syringe length between the various brands of prefilled syringes, which can then
result in the syringe volume displayed on the Salient being different to the volume determined by the syringe
volume markings. Be aware, the syringe volume markings may not be accurate and should only be used
as a general guide to syringe volume.
1) Exit service mode, install the 100ml adapter and an empty 100ml syringe.
2) Fully purge the syringe to the current 0ml volume position.
3) Re-enter service mode and select the Zero Volume Cal option to display the screen above.
4) Move the piston forward so the seal can be seen just touching the end of the syringe barrel.
5) Press the save button when satisfied with the zero volume position.
6) Repeat steps 6 to 10 with the 150ml adapter installed and an empty 150ml syringe.
19 of 44
Salient Service Manual REF : SM040001-18
Sensor reading
Previous stored
threshold
Back to menu
There are two similar methods of calibrating the Plunger Detect Threshold, manually using either a ZY6320
syringe or a Prefilled Syringe Adapter and automated when using the pre-aligned Sensor Calibration Fixture
MDMP021.
1) Exit service mode and on the fill screen, move the piston forward until the clear piston disk is just below
the white plunger body. Focus on the black sensor within the piston disk.
2) Re-enter service mode and select the Plunger Cal option to display the screen above.
3) Advance the piston by pushing on the up arrow until the sensor is half covered by the plunger body.
Page 16 of 35
4) For Prefilled Syringe Adapters, advance the piston until the carriage flag half covers the sensor. This
is shown in the picture above.
5) When using the Sensor Calibration Fixture MDMP021, simply place the fixture on the end of the
pusher and the sensor will be half covered without need of alignment as in step 3.
6) With the sensor half covered, press the SET button to store the new calibration threshold.
7) The sensor reading (displayed as hexadecimal) should change as the sensor enters the plunger body
and values of FFFF or 0000 indicates a sensor problem.
20 of 44
Salient Service Manual REF : SM040001-18
3.8 Pressure
Perform Zero Pressure calibration first, before completing Fluid Pressure calibration at working pressures.
1) Exit service mode and install 2 x ZY6320 syringes or a DC030 and 100ml prefilled syringe on the
contrast side only for a Japanese Salient.
2) Using the manual fill control, move the plunger to 190 ml on the ZY6320 syringes and 100ml on the
prefilled syringe.
3) Move the plunger forward slightly to ensure full engagement (approximately 185 ml or 95ml
respectively).
4) Enter service mode and select the Pressure Cal option to display the screen above.
5) Select Left Motor on a dual system.
6) Press START.
7) Wait until “Calibrated OK” is displayed. 8) Repeat for the Right Motor.
Page 17 of 35
21 of 44
Salient Service Manual REF : SM040001-18
WCAS079 or WCAS091
cable between pressure
gauge and J5 on the base
board.
22 of 44
Salient Service Manual REF : SM040001-18
NOTE: After reassembly of base, connect mains power and ensure that the mains icon is displayed on the
screen. Failure to display indicates J100 jumper has not been installed correctly.
Page 18 of 35
3.8.2 Fluid Pressure Calibration for Japanese Salient
1) Exit service mode, fill the syringe with water and connect pressure gauge and valve assembly.
2) Remove base, EMI pedestal covers and connect WCAS079 cable between the pressure gauge output
socket and J5 on the base board.
3) Remove jumper at J100 on the base board.
4) Check pressure gauge zero and battery capacity.
5) Enter service mode and select the Pressure Cal option.
6) Press Zero Pressure button to toggle to Fluid Pressure (1ml/s flow rate will be selected).
7) For the Left Motor on a dual system only, use a ZY6320 syringe.
8) Press START button and increase restriction until the pressure gauge reads between 180 and 200psi.
Note, there is no pressure limit in service mode, so be careful not to exceed 250psi.
9) When the pressure is stable, the green line (injector pressure) and the yellow line (pressure gauge) will
be flat. Press the save button and then STOP.
10) Repeat at 5 and 10ml/s (make sure to adjust the restriction to achieve the same 180 to 200psi).
11) When complete, exit service mode and run test injections of 2ml/s and 5ml/s at a constant pressure of
approximately 150psi to ensure the system is within 50psi of the pressure gauge reading.
12) For the Right Motor on a dual system and the Left Motor on a single system, use a DC030 and 100ml
prefilled syringe.
13) Press START button and increase restriction until the pressure gauge reads between 180 and 200psi.
Note, there is no pressure limit in service mode, so be careful not to exceed 250psi.
14) When the pressure is stable, the green line (injector pressure) and the yellow line (pressure gauge) will
be flat. Press the save button and then STOP.
15) Repeat at 7, 12, 13 and 14ml/s (make sure to adjust the restriction to achieve the same 180 to 200psi
for all flow rates).
16) Save button turns yellow to confirm the saved value for each of the four speeds.
17) Should you need to refill the syringe, press the refill button to the left of the save button.
18) When complete, exit service mode and run test injections of 2ml/s and 7ml/s at a constant pressure
approximately 150psi to ensure the system is within 50psi of the pressure gauge reading. If available,
check the DC029 and 150ml prefilled syringe using the same setup.
19) Remove WCAS079 cable and replace jumper J100.
NOTE: After reassembly of base, connect mains power and ensure that the mains icon is displayed on the
screen. Failure to display indicates J100 jumper has not been installed correctly.
3.9 Serial No
1) This button is used as an indication only. The serial number is set during the manufacture process and
can be set in the field using the My Salient Service Application software.
23 of 44
Salient Service Manual REF : SM040001-18
Page 19 of 35
3.10 Syringe Cycle Test
For production use only, not to be used in the field.
Number of Cycles
Selection
Start Test
24 of 44
Salient Service Manual REF : SM040001-18
1) Select the number of cycles to run. The number of cycles ranges from 1 to 1000. A typical test would
involve 10 cycles to get an indication of the stability of the FRAM 2) Press Start to begin the test.
3.14 ImaxiFlow
ImaxiFlow is a feature available on Salient Dual systems. Protocols can be created that allow
simultaneous flow of both contrast and saline. To enable the ImaxiFlow feature, an alphanumeric
activation key must be obtained from Imaxeon.
Page 20 of 35
3.15 WiFi Settings
Networking type
Salient IP Address
TCP/IP port
WiFi Channel
WiFi Activated
1) The network type can be toggled between WIZnet and None. This will allow for future networking
options
2) The Wireless NetId can be changed to match what is set in the RCU, which will allow a connection to
be established. See Error! Reference source not found.Error! Reference source not found..
3) For testing/debugging purposes, the NetId can be modified to be different from the 10 presets.
25 of 44
Salient Service Manual REF : SM040001-18
4) The IP address of the Salient can be entered here. This will also need to be entered as the Salient IP
address in the RCU. See Error! Reference source not found..
5) The TCP/IP port can be configured. This must match the port as defined in the RCU. See Error!
Reference source not found..
6) The WPA2 security key can be configured using these controls. These must match the key that is
entered in the RCU. See Error! Reference source not found..
7) The WiFi channel can be configured. The valid channel range is 1 – 16. This must match the channel
that is selected in the RCU. See Error! Reference source not found.
8) The WiFi radio can be disabled using this control.
Page 21 of 35
26 of 44
Salient Service Manual REF : SM040001-18
1. Ensure that the Salient is powered off and disconnected from mains supply.
2. Remove the base cover by levering two of the four
corners with a flat bladed screwdriver.
Page 22 of 35
27 of 44
Salient Service Manual REF : SM040001-18
Page 23 of 35
4.4 Performing a Firmware Upgrade
If a new firmware version is to be installed in the Salient, follow this procedure:
28 of 44
Salient Service Manual REF : SM040001-18
1. Ensure that the Salient is powered off and disconnected from mains supply.
2. Remove the base cover as described in Section 4.2.
3. Remove the EMI pedestal cover by unscrewing the two fasteners shown in the following diagram.
4. Locate the USB Type B socket J3 on the base board, as shown below.
5. Connect USB (Type A to B) cable to J3 and one of the USB ports on your laptop.
J3 USB on
base board
Page 24 of 35
29 of 44
Salient Service Manual REF : SM040001-18
8. Click on the UPGRADE button.
9. Browse and select firmware file (.mot format) to be installed on injector and then click the Start
button. If you have not saved the Salient Report, then you will now be prompted to do so. Firmware
upgrades can result in data loss and the Salient Report allows you to recover quickly.
10. Progress will be displayed. If interrupted, close and start again from step 8.
11. When download is complete, the following message will be displayed and wait until MySalient has
restarted automatically.
Click on the DIAGNOSTIC action button. Efficacy data is recorded in order for Imaxeon to monitor the
reliability of individual injectors and to gather data about the overall reliability of the injectors in the field.
This data should be saved to a file and emailed to salient@imaxeon.com at every annual service.
30 of 44
Salient Service Manual REF : SM040001-18
Page 25 of 35
If the efficacy counts are not cleared at each annual PM, a reminder warning will appear when the injector
is powered on.
Click on the SETUP action button, the General tab displays as below. The primary reason for needing these
setup functions is to re-establish the system setup after replacing the main board.
Click on the REPORT action button, the Salient Report tab displays as below. The Salient Report contains
the head serial number, the calibration data file, saved protocols, user option settings and the WiFi channel
and setup. This information can be saved and then uploaded to a new main board.
31 of 44
Salient Service Manual REF : SM040001-18
Page 26 of 35
Click of the REPORT action button, the Salient Alarms tab displays as below. Details of the last 40 alarms
are stored on the injector and may be uploaded to this screen.
32 of 44
Salient Service Manual REF : SM040001-18
Page 27 of 35
33 of 44
Salient Service Manual REF : SM040001-18
5.2 Upgrade
Upgrades to the RCU’s operating software can be installed directly on to the RCU. Refer to SM040008
Salient RCU Software Installation Procedure for full details.
Be aware of the compatibility requirement between Salient firmware version and the RCU software version,
as detailed in the chart below.
34 of 44
Salient Service Manual REF : SM040001-18
Page 28 of 35
This allows the user data for the RCU including injection history and log files to be saved to the USB flash
drive (that has been formatted by the RCU). This archive file can then be opened (using 7zip or winrar)
and the files can be read using any text editor.
This allows a USB flash drive to be connected and formatted to allow it to be used for upgrading, and
system report downloading.
Insert a USB flash drive and press “Format RCU USB Stick” and wait for the formatting to complete.
WARNING: This will erase all the data on the flash drive
35 of 44
Salient Service Manual REF : SM040001-18
Page 29 of 35
During a button press test, each button has two numbers showing the number of presses, followed by the
number of releases. Following each press of the screen, the numbers in any of the boxes should be
equal. On the left of the screen a total of all button presses is shown and these should always be equal
when the screen is not being touched.
The drag test has a similar total presses/releases indication shown on the left, and these must be equal
when the screen is not being touched. While dragging across the screen, the image should remain green
and not flicker red, it is important to drag to the extremities of the coloured box. When the finger is
removed from the screen, the box colour will change to red
36 of 44
Salient Service Manual REF : SM040001-18
Page 30 of 35
The My Salient program replaces the original iCubed program and must be used to install V1.3.40 and later
Salient operating firmware. The My Salient program needs to be installed on your PC using an account with
administrator privileges.
37 of 44
Salient Service Manual REF : SM040001-18
1. Open the My Salient Setup Wizard.
Page 31 of 35
38 of 44
Salient Service Manual REF : SM040001-18
5. Choose your preferences for creating shortcuts
to run the program.
7. After installing the software, connect to J3 on the base board and any USB port on your laptop
to allow Windows to complete the driver installation. This may not be necessary if you are
upgrading the client software and the drivers have been previously installed.
8. If Windows 7 fails to install the drivers correctly, refer to TN040005 for additional instructions.
Page 32 of 35
39 of 44
Salient Service Manual REF : SM040001-18
7 Technical Description
40 of 44
Salient Service Manual REF : SM040001-18
41 of 44
Salient Service Manual REF : SM040001-18
7.1.1 Microcontroller
The main processor in the Salient is an SH 2A Renesas processor, containing dual 3 phase motor
controllers and multiple A/D channels used for position measuring.
7.1.3 Memory
Main memory is internal to the SH 2A. Additional FRAM contained in the RTC is used to store non-volatile
information such as calibration data, user routines, error log, current status, etc. The RTC itself is used to
time stamp system errors.
7.1.8 IR Decoder
The remote control employs a HT12D infrared decoder.
42 of 44
Salient Service Manual REF : SM040001-18
Page 34 of 35
7.4 PA0403 or PA0416: Back Board
The back board has three functional circuits:
• LED indicators to show motor movement, inject ready, injecting, warnings and alarm states.
• Infrared receivers for the remote control.
• Final drive encoder (FDE) to cross check the position count calculated from the motor position
sensors. The FDE consists of a hall sensor for each motor, which is triggered by a magnet on the
ball screw gearing.
43 of 44
Salient Service Manual REF : SM040001-18
Page 35 of 35
44 of 44