Publications
Direction 2335256-100
Version III
Last update : June 2008
TRACERlab MX FDG
Service manual
GE Healthcare
GEMedicalSystemsBeneluxs.a.
RueMarieCurie,78
B4431Loncin(Lige),BELGIUM
www.gehealthcare.com
Erratum
TRACERlabMXServicemanual
Bythiserratumbeinformedthatthevoltagespecificationchangedandyou
havetoconsider:
240Vinsteadof220V
115Vinsteadof110V
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DISTRIBUTOR :
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TABLE OF CONTENTS
CHAPTER 1 : INTRODUCTION
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CHAPTER 2 :
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CHAPTER 3 :
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CHAPTER 4 :
CE MARKING
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1.
General description
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2.
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3.
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4.
Connections
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5.
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6.
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7.
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8.
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9.
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2.
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3.
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4.
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6. Operation of the vacuum pump
7. Operation of the clamps holding the cassette in place
8. Resetting of the outputs
CHAPTER 7 : CALIBRATION OF THE ACTIVITY DETECTORS
1. Routine calibration procedure
2. Manual calibration procedure
3. Setting the four activity detectors to zero
4. Display the detectors slope and offset
5. Adjustment of the detector positioning in the case of saturation
CHAPTER 8 : WEEKLY MAINTENANCE
CHAPTER 9 : YEARLY MAINTENANCE
1. Replacement of the tube from the eluent pinch valve
2. Replacement of the tube from the 18F inlet pinch valve
3. Replacement of the waste cap and waste tube
4. Checking the TRACERlab MX FDG
4.1 Checking the valve connected to the pump (valve 2-1)
4.2 Checking the electronic vacuum gauge
4.3 Checking the vacuum pump
4.4 Checking the high flow-rate, the HF valve (valve 1-19)
and the nitrogen valve (valve 2-5)
4.5 Checking the low flow-rate, LF valve (valve 1-20)
and the nitrogen valve (valve 2-5)
4.6 Checking the low pressure level and the LP valve (valve 1-23)
4.7 Checking the high pressure level and the HP valve (valve 1-18)
4.8 Checking the Vac valve (valve 1-17)
4.9 Checking the Vacuum to 18O water valve (valve 1-21)
4.10 Checking the kit exhaust valve (valve 1-24)
4.11 Checking the eluent valve (valve 1-15)
4.12 Checking the 18F inlet valve (valve 1-16)
4.13 Checking the heater temperature
4.14 Checking the syringe drivers
4.15 Checking the position of the 3 ml syringe driver
4.16 Checking the rotating actuators and the Compressed air valve (valve 2-3)
4.17 Checking the clamp kit mechanism and the Compressed air valve (valve 2-3)
5. Calibration of the detectors
CHECKLIST PROPER FUNCTIONING OF THE TRACERlab MX FDG
CHAPTER 10 : EXTENSIVE MAINTENANCE AFTER 3 YEARS
CHAPTER 11 : CLEANING AND SANITIZING
CHAPTER 12 : TROUBLESHOOTING
1. Error detected during the synthesizer test
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1.1 Heater error
1.2 Syringue actuator error
1.3 Compressed air error
1.4 Nitrogen error
2. Syringe driver error
3. Error detected during the cassette test
4. During synthesis an error message on the screen informs you that the pressure
in the waste bottle did not rise as expected
5. Abnormality during the preliminary steps before the transfer of the irradiated water
5.1 The syringes are not hooked onto the syringe drivers
5.2 The mannose triflate precursor was not diluted properly
5.3 The activity cannot be transferred from the target to the TRACERlab MX FDG
6. Low yield (<45%EOS)
6.1 The activity was not trapped properly onto the QMA cartridge and a large amount
of activity is in the enriched water recovery vial
6.2 The activity was not trapped properly onto the QMA cartridge and the amount
of recovered 18O water is much lower than the target volume
6.3 A large amount of activity remains trapped on the QMA cartridge
after elution and/or after synthesis
6.3.1 Some activity was sent to the reservoir after the start of the synthesis
6.3.2 The eluent was not transferred properly from its vial into the reservoir
6.3.3 The eluent was transferred into the reservoir but has not passed
through the QMA cartridge
6.3.4 The eluent has passed through the QMA cartridge but the activity
has not been eluted
6.4 The activity was not trapped properly on the TC18 cartridge before hydrolysis
6.4.1 The main part of the activity in the waste bottle is in 18F-form
6.4.2 There is a large amount of [18F]-2-18FFluro-1,3,4,6-tetra-O
-acetyl-D-glucose ([18F]-TAFg) (up to 50%) in the waste bottles
6.5 The hydrolysis tC18 cartridge became blocked during the trapping of the labeled
precursor or during the rinsing steps before hydrolysis, leading to liquid leaks
6.6 The activity is not eluted out of the tC18 cartridge properly after hydrolysis
6.7 Some activity trapped onto the tC18 cartridge is lost during hydrolysis
7. Fluctuating yields
8. There is no liquid in the final vial or the amount of FDG solution in the final
vial is below 16 ml
9.
Other possible explanations for low yields or a failed synthesis
10. The quality of the final product does not meet the pharmaceutical requirements
10.1 The pH is too high (>8.5)
10.2 The pH is too low (>4.5)
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10.3 The FDG solution is not clear and colorless
10.4 There are unknown radioactive impurities in the FDG solution
10.5 The amount of residual free 18F ions is abnormally high
10.6 The amount of partially hydrolyzed labeled precursor is abnormally high
10.7 The pH is too high, the amount of residual ethanol is too high
and the osmolality is too high
CHAPTER 13 : REPORT ANALYSIS
1. Enriched 18O-water recovery
2. Labeling of the precursor and prepurification
3. Hydrolysis, purification and transfer to the final vial
CHAPTER 14 : REMOTE CONTROL BOX
CHAPTER 15 : GENERAL CHECK PROCEDURE IN THE CASE OF LOW YIELDS
APPENDIX
Removal of the cove
Replacement of the activity inlet pinch valve tube
Replacement of the elution system pinch valve tube
Replacement of the elution system tube inserts (on the conical block)
Replacement of the elution system
Replacement of the electronic vacuum gauge
Replacement of the vacuum pump
Replacement of the 30 ml syringe actuator mechanism
Replacement of the 3 ml syringe actuator mechanism
Adjustment of the activity detector position in the case of saturation
Adjustment of the pressure levels : High Pressure (HP) & Low Pressure (LP)
Replacement of the nitrogen filter cartridge and/or compressed air filter cartridge
Replacement of an internal valve
Replacement of the 18F inlet pinch valve
Replacement of the PLC power supply
Replacement of the 24 Vdc power supply
Replacement of the CPU battery
Replacement of the mains fuse
Replacement of the heater fuse
Replacement of the PLC fuse
MR-001-001
MR-001-002
MR-001-003
MR-001-004
MR-001-005
MR-001-006
MR-001-008
MR-001-009
MR-001-010
MR-001-011
MR-001-012
MR-001-013
MR-001-015
MR-001-016
MR-001-017
MR-001-018
MR-001-020
MR-001-021
MR-001-022
MR-001-023
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CHAPTER 1 - INTRODUCTION
The TRACERlab MX FDG is a compact automated system that converts externally produced 18F-fluoride into
2-[18F]-fluoro-2-deoxyglucose (FDG) ready for quality control, usable in Positron Emission Tomography (PET).
The TRACERlab MX FDG : Service Manual is one part of the global package entitled TRACERlab MX FDG : User
Documentation. It contains the necessary information to assist the user during maintenance and servicing operations
on the TRACERlab MX FDG : description of the maintenance mode, calibration procedure for the activity detectors,
troubleshooting information, weekly and yearly checks and maintenance, repairing procedures, etc.
Before any maintenance and servicing operation is carried out on the TRACERlab MX
must read the TRACERlab MX FDG : Service Manual and be fully aware of its contents.
FDG
, each operator
The TRACERlab MX FDG : User Documentation package consists of three additional manuals :
TRACERlab MX FDG : Preinstallation and Installation Manual
Contains the information necessary to install the TRACERlab MX FDG and the site requirements.
TRACERlab MX FDG : Operator Manual
Contains the necessary information to assist the operator in routine FDG production using the
TRACERlab MX FDG, i.e. health and safety information, a short description of the equipment and the
chemical process, a description of the control tools and displays available to the user, and all necessary
operating instructions.
TRACERlab MX FDG : Consumable Manual
Contains all the information related to the consumables such as reagents needed for the production of
FDG, single use cassette and additional items needed for the production of FDG.
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All personnel associated with the operation of the TRACERlab MX FDG have to be informed of all applicable
radioprotection laws and regulations and must be qualified in the handling of radioactive material.
The TRACERlab MX FDG is not shielded. It must be operated within a hot cell with sufficient shielding to be
compliant with local radioprotection regulations. The waste bottle must be shielded, even when located within the
hot cell. It is mandatory to close the door of the hot cell and keep the door closed during transfer of the radioactive
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F fluoride from the cyclotron to the TRACERlab MX FDG and during the entire FDG synthesis. After synthesis,
the vial containing the FDG solution has to be placed in a shielded container. The FDG vial must be handled
using a manipulator (pliers) to avoid any radiation hazard during this operation. The FDG solution can also be
transferred directly into a shielded vial located either in the production hot cell, or in a neighboring hot cell.
After synthesis, the 18F transfer line, some parts of the TRACERlab MX FDG, the waste bottle and the disposable
synthesis cassette will still be contaminated with radioactive material. Therefore the door of the hot cell must be
kept closed until sufficient decay before removal of the cassette.
After use, although it was rinsed, the disposable synthesis cassette contains residues of radioactive material. Do
not remove the cassette before complete decay if it is not necessary. If possible, leave it in place for 24 hours. If
the cassette has to be removed before complete decay of the radioactivity, ensure that this operation is done in a
manner that avoids unnecessary radiation exposure to the operator (the removal operation must be done quickly,
and the door of the hot cell must be closed immediately afterwards). The cassette contaminated with radioactive
material must be discarded in compliance with local radioprotection regulations. It is recommended that it is
stored behind shielding for at least 48 hours after synthesis. Note that the cassette can also be contaminated with
long half-life radioactive target impurities. Measure the remaining radioactivity on the cassette in order to ensure
proper storage until sufficient decay.
It is mandatory to use protective gloves when handling the contaminated cassette or when operating the
TRACERlab MX FDG after a hot synthesis.
Accidental liquid spillages may contain radioactive material. Use protective gloves while wiping off liquid
spillages.
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In the event of a radiation accident, all personnel must observe the applicable local laws and regulations.
Following caustic substances are involved in the FDG production process with TRACERlab MX FDG : sodium
hydroxide solution and hydrochloric acid.
Avoid skin and eye contact with these substances while connecting the disposable synthesis cassette and the
reagents onto the TRACERlab MX FDG, and while removing the cassette and the reagents from the TRACERlab
MX FDG, since skin burns and damage would result. In the event of contact with the skin or eyes, wash the affected
area immediately with copious amounts of water and seek prompt medical attention.
Use protective gloves and safety glasses when handling the reagents and the cassette.
After use, the disposable synthesis cassette may contain residues of caustic substances. Ensure that the cassette
is discarded in a manner avoiding any risk of hazard due to these caustic substances.
Following toxic substances are involved in the FDG production process with the TRACERlab MX FDG : acetonitrile,
sodium hydroxide solution and hydrochloric acid.
These toxic substances are hazardous if inhaled or swallowed. In the event of swallowing do not induce vomiting
and seek prompt medical attention.
Avoid skin and eye contact with these substances while connecting the disposable synthesis cassette and the
reagents onto the TRACERlab MX FDG, and while removing the cassette and the reagents from the TRACERlab
MX FDG. In the event of skin and eye contact, wash the affected area with copious amounts of water and seek
prompt medical attention.
Use protective gloves and safety glasses when handling the reagents and the cassette.
After use, the disposable synthesis cassette may contain residues of toxic substances. Ensure that the cassette is
discarded in a manner avoiding any risk of hazard due to these toxic substances.
Following inflammable substances are involved in the FDG production process with the TRACERlab MX
acetonitrile and ethanol.
These inflammable substances have to be handled in a manner avoiding any risk of ignition.
Use protective gloves when handling the reagents and the cassette.
FDG
After use, the disposable synthesis cassette may contain residues of inflammable substances. Ensure that the
cassette is discarded in a manner avoiding any risk of hazard due to these inflammable substances.
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Before powering up the TRACERlab MX FDG, while installing the equipment, make sure that the voltage
corresponds to the requirements (label at the rear of the TRACERlab MX FDG)
When carrying out maintenance on the TRACERlab MX FDG, make sure that the power supply is cut off prior to
any operation.
Cut off the power supply when removing the cover of the TRACERlab MX FDG.
symbol and is compliant with the applicable European
Note that the TRACERlab MX FDG is marked with the
Directives and norms (cf. section related to CE marking)
A heating device is located on the front part, in the cavity destined for the reaction vessel.
Do not touch the heating device when mounting the cassette onto the TRACERlab MX
the cassette.
FDG
, or when removing
In the case of malfunctioning, or when the heater is operated through the maintenance mode, high temperatures
(up to 200 C) can be reached. To avoid skin burns, do not touch the heating element.
The following moving parts are part of the TRACERlab MX FDG : three syringe drivers, the pneumatic rotating
actuators, the pneumatic clamps holding the cassette in place, and the elution mechanism moving down onto the
reservoir of the cassette when the cassette is clamped.
Do not touch these parts when they are in movement or when the cassette is clamped onto the TRACERlab MX FDG
The TRACERlab MX FDG weighs about 50 kg and can cause injury if not installed in a stable manner.
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2.10 Accident involving personal injury
In the event of an accident involving personal injury, seek urgent medical attention.
Dont touch the heating element while operating the TRACERlab MX FDG.
The heater can reach high temperatures and cause skin burns.
Location of the label :
Front panel, near the heating element.
Read the service manual before any servicing or sanitizing operation. Refer the servicing to
qualified personnel.
Location of the label :
Right-hand lower corner on the front panel and left-hand lower corner on the rear panel.
CAUTION !
115V
AC
115V
115V
AC
AC
240V
240V
AC
240V
AC
Switch off the mains power before removing the cover. Refer the servicing to qualified
personnel.
Location of the label :
Right lower corner on the front panel and left lower corner on the rear panel.
AC
Cut off the main power supply before removing the cover of the TRACERlab MX FDG or before any replacement
of worn parts or repairing procedure.
The following components, represented in the pictures below, are powered at 220V (or 115 V).
- The main power supply plug and the wires connected to it
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- The 24Vdc power supply and the wires connected to it
- The PLC power supply and the wires connected to it
- The transformer and the wires connected to it (only for a TRACERlab MX
supply)
- The main terminal connector block and the wires connected to it
- The solid state relay and the wires connected to it
- The heater and the wires connected to it
FDG
Do not touch these components when the TRACERlab MX FDG is powered up.
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24 V DC power supply
Toroidal Transformer
(only for equipment powered at 120V)
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Heater
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Radiation
WEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES. IN
CASE OF CONTACT WASH ABUNDANTLY THE AFFECTED AREA WITH WATER
AND REQUEST MEDICAL ATTENTION.
VERIFY THAT THE SYSTEM IS INSTALLED IN A STABLE SUPPORT.
Chemical
Mechanical
/...
Radiation
DO NOT START ANY JOB IF DOSE RATE TOO HIGH ACCORDING WITH THE JOB
TIME NEEDED AND YOUR PERSONAL ACCUMULATED DOSE.
DO NOT START ANY JOB IF THE DOSE RATE IS TOO HIGH, ALWAYS REQUEST
APPROVAL FROM THE CUSTOMER RADIATION OFFICER.
CONTROL MEASURES
PPE
Ionization effect.
CAUSES
Chemical
Radiation
None
Radiation
Risk HAZARD
Level
TASK
RISK LEVEL
PPE Ensure the following PPE is available and worn at all times
SAFETY SHOES
FULL BODY LAB COAT
SHOES COVER
SAFETY GLASSES OR FACE SHIELD
PROTECTIVE GLOVES
PERSONAL FILM AND ELECTRONIC DOSIMETER
WORKING ENVIRONMENT Ensure the following factors are present;
ROOM VENTILATION
ADEQUATE LIGHTING
LOTO Lock out and verify all
ELECTRICAL SUPPLIES
GASEOUS SUPPLIES
COMPRESSED AIR SUPPLIES
CHAPTER 3 : TRACERLAB MX
SERVICE JOB SAFETY ANALYSIS (1)
Visual inspection
Inspect cables and connectors
TASK
Radiation/
regulation
CAUSES
Radiation/
regulation
Chemical
Electrical
None
None
Electrical
Chemical
Radiation
Risk HAZARD
Level
CONTROL MEASURES
/...
WEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES. IN
CASE OF CONTACT WASH ABUNDANTLY THE AFFECTED AREA WITH WATER
AND REQUEST MEDICAL ATTENTION.
WEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES. IN
CASE OF CONTACT WASH ABUNDANTLY THE AFFECTED AREA WITH WATER
AND REQUEST MEDICAL ATTENTION.
RISK LEVEL
TRACERLAB MX
SERVICE JOB SAFETY ANALYSIS (2)
Electrical
PPE
None
None
None
None
None
None
Thermal
None
None
CONTROL MEASURES
WEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES.
IN CASE OF CONTACT WASH ABUNDANTLY THE AFFECTED AREA WITH WATER
AND REQUEST MEDICAL ATTENTION.
WEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES. IN
CASE OF CONTACT WASH ABUNDANTLY THE AFFECTED AREA WITH WATER
AND REQUEST MEDICAL ATTENTION
End
AVOID TO TOUCH THEM WHILE THEY ARE MOVING OR WHEN THE KIT IS
CLAMPED.
CAUSES
Chemical
Chemical
Risk HAZARD
Level
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TASK
26
RISK LEVEL
TRACERLAB MX
SERVICE JOB SAFETY ANALYSIS (3)
Version III - Last Update : June 2008
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CHAPTER 4 - CE MARKING
The TRACERlab MX FDG is marked with the
harmonized standards :
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4. Connections
The permanent connections are located at the rear of the module. Refer to the TRACERlab MX FDG : Preinstallation
and installation manual for more details.
FDG
- COMPR AIR connection : compressed air inlet (clean and dry air at 6-8 bars) with quick connect fitting for
4 mm O.D. tube;
- N2 connection : synthesis gas inlet (dry nitrogen of high purity at 2-10 bars) with female Luer lock
connector;
- INPUTSplug : logical input socket plug (not used for the FDG synthesis);
- OUTPUTS plug : logical output socket plug (not used for the FDG synthesis);
- REMOTE CONTROL plug : logical input/output socket plug allowing connection to the Remote Control
Box, or to get a 24 Vdc signal when the TRACERlab MX FDG is ready to receive the irradiated 18O-water and
when the FDG is ready. Note that the connection of the Remote Control Box is optional and not required to
operate the TRACERlab MX FDG;
- REMOTE DETECTOR plug : socket plug allowing switching from the built-in activity detector located at
the cavity destined to receive the final product vial, to an external detector in case the final vial is not located
in the TRACERlab MX FDG but for example in a neighboring hot cell;
- HEATER FUSE;
- P.C. plug : serial connection plug, standard DB9 plug for RS232 serial communication cable between the
TRACERlab MX FDG and the operator PC;
- Power supply plug : standard IEC plug (240 Vac or 115 Vac.) with grounding and fuses;
- TO WASTE connection : male luer lock connector to which the inlet of the external waste bottle is
connected;
- FROM WASTE connection : female luer lock connector to which is the outlet of the external waste bottle is
connected;
- EXHAUST connection : gaseous outlet of the pump, male luer lock connector to which a gas collection bag
may be connected (to let gaseous radioactivity decay) or a line leading to the chimney of the hot cell;
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The following connections located on the front panel of the TRACERlab MX FDG ensure the connections between
the TRACERlab MX FDG and the cassette.
- 18O-Water recovery fitting, located on the bottom left of the front panel, used to set the 18O-Water recovery
vial to vacuum;
- A permanent tube, located below the 18F inlet valve on the left side of the front panel, connects the front
panel to the elution system and the reservoir of the cassette. The corresponding female luer lock connector on
the front panel provides pressure and vacuum to the elution system and the reservoir receiving the irradiated
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O-water ;
- The target line (i.e. the line used to transfer the irradiated 18Owater from the cyclotron to the TRACERlab MX FDG) is
connected directly to the elution system and the reservoir via the tube passing through the 18F inlet valve on the left
side of the front panel;
- 2 female luer lock connectors are used to connect the cassette to the TRACERlab MX FDG ;
- Pressure inlet connector on the left side of the front panel : supplies gas (nitrogen) to the left of the cassette ;
- Exhaust connector on the right side of the front panel, sets the cassette to vacuum and drains the fluids to the
waste;
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1
3
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5
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4
18
6
17 16
15
14
13
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12
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24
1
11
Front view without the front cover and without the white lead piece matching the cassette.
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N Name and description
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2
3
4
5
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FDG
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N Name and description
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2
3
4
5
Power supply : 24 Vdc, 150 W supply, used to energize all the PLC outputs
PLC power supply : 110 Vac or 220 Vac to 24 Vdc energizes the PLC
PLC key : left : RUN middle : REMOTE right : PROGRAM
PLC CPU (SLC 5/04 16 K RAM) : processor containing the PLC programs (ladders)
PLC 32 logical outputs (24 Vdc 0.5A per point 8A per module) : 32 logical outputs electronically
protected.
6 PLC 16 logical outputs (24 Vdc 1A per point 8A per module) : 16 logical outputs electronically protected.
7 PLC 16 logical inputs (24 Vdc) : 16 logical inputs electronically protected.
8 PLC 4 analog inputs : 3 cards of 4 analog inputs.
9 Solid state relay : controls the heater resistance
10 Subassembly of rotating actuators and related valve manifolds # 11 to 15.
11 Subassembly of rotating actuators and related valve manifolds # 6 to 10.
12 Subassembly of rotating actuators and related valve manifolds # 1 to 5.
13 Vacuum pump : sets the waste bottle and the cassette to vacuum.
14 Transformer : converts 115 Vac to 220 Vac (only on TRACERlab MX FDG at 115Vac).
15 Nitrogen filter : filters the incoming nitrogen at 7 m.
16 EXHAUST connection : gaseous outlet of the pump, male luer lock connector to which a gas collection bag
may be connected (to let radioactivity decay) or a line leading to the chimney of the hot cell.
17 FROM WASTE connection : female luer lock connector to which is connected the outlet of the external
waste bottle (tube which sets the waste bottle to vacuum)
18 TO WASTE connection : male luer lock connector to which is connected the inlet of the external waste
bottle (tube connecting the outlet of the cassette to the waste bottle)
19 Power supply plug : standard IEC plug (240 Vac or 115 Vac.) with grounding and fuses.
20 P.C. plug : serial connection plug, standard DB9 plug for RS232 serial communication cable between the
TRACERlab MX FDG and the user interface computer.
21 HEATER FUSE. Housing for the fuse dedicated to the heater.
22 REMOTE DETECTOR plug : plug allowing the switching from the built-in activity detector located at the
cavity destined for the final product vial, to an external detector, in the case where the final vial is not located
in the TRACERlab MX FDG but for example in a neighboring hot cell.
23 REMOTE CONTROL plug : logical input/output socket plug allowing connection of the Remote Control
Box, or to get a 24 Vdc signal when the TRACERlab MX FDG is ready to receive the irradiated 18O-water, or
when the FDG is ready.
24 OUTPUTS plug : logical output socket plug (not used for the FDG synthesis).
25 INPUTS plug : logical input socket plug (not used for the FDG synthesis).
26 N2 connection : synthesis gas inlet (dry nitrogen of high purity at 2-10 bars) with female Luer lock
connector.
27 COMPR AIR connection : compressed air inlet (clean and dry air at 6-8 bars) with quick connect fitting for
4 mm O.D. tube.
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6
7
8
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N Name and description
1 HP valve (valve 1-18) : the high pressure valve provides high pressure (0.7 bars) to the elution system and the
reservoir of the cassette.
2 HF valve (valve 1-19) : the high flow valve provides flow-rate (between 300 and 600 ml/min at a pressure of about
0.7 bars) to the pressure inlet connection on the front panel. The flow is fixed by a flow restrictor consisting of a
very small inner diameter tube located downstream of the valve.
3 LF valve (valve 1-20) : the low flow valve provides flow-rate (between 25 and 45 ml/min at a pressure of about 0.7
bars) to the pressure inlet connection on the front panel. The flow is fixed by a flow restrictor consisting of a very
small inner diameter tube located downstream of the valve.
4 Electronic circuit board containing resistances for the activity detectors.
5 HP pressure regulator : the high pressure regulator sets the pressure to 0.7 bars for the HP valve (valve 1-18), the
HF valve (valve 1-19) and LF valve (valve 1-20).
6 Compressed air pressure switch : checks if the incoming air pressure reaches a minimum of 3.5 bars.
7 LP pressure regulator : the low pressure regulator sets the pressure to 0.4 bars for the LP valve (valve 1-23).
8 Nitrogen pressure switch : checks if the incoming nitrogen pressure reaches a minimum of 1.5 bars.
9 Compressed air filter and pressure regulator : filters the incoming compressed air at 5m and sets the air pressure
to 4.5 bars.
10 Vac valve (valve 1-17) : the vacuum valve connects the waste bottle to the elution system and the reservoir of the
cassette.
11 LP valve (valve 1-23) : the low pressure valve provides low pressure to the elution system and the reservoir of the
cassette.
A pressure switch verifies the supply of nitrogen to the TRACERlab MX FDG. The nitrogen supplied to the
TRACERlab MX FDG is filtered by a filter located near the bottom of the panel, and the pressure level is regulated
through 2 gas pressure regulators : the high pressure regulator (HP) and the low pressure regulator (LP).The flowrate settings are determined by adjusting the pressure regulators, and by fixed flow restrictions downstream from
the regulators.
- The line opened by valve n1-20 (upper regulator, 0.7 bars) sets the low gas flow-rate used during the evaporation
process;
- The line opened by valve n1-19 (upper regulator, 0.7 bars) sets the high flow-rate used for pressurizing vials
and syringes, for flushing transfer lines, ...etc.
- The line opened by valve n1-23 (lower regulator, 0.4 bars) sets the pressure used to push the target water
through the recovery cartridge;
- The line opened by valve n1-18 (upper regulator, 0.7 bars) is used to pressurize the eluent and to flush the anion
exchange cartridge;
- The line opened by valve n1-17 is used to set the reservoir above the anion exchange cartridge to vacuum. This
aids the transfer from the target.
A pressure switch verifies the continued supply of compressed air to the TRACERlab MX FDG. The compressed
air supplied to the TRACERlab MX FDG is regulated and filtered by the pressure regulator located near the bottom
of the panel.
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N Name and description
1
3
4
5
Kit exhaust valve (valve 1-24) : connects the waste bottle to the Exhaust connector on the front panel.
Used to creates a vacuum in the cassette (also called kit) and to drain the out-coming waste fluids to the
waste bottle.
Valve 2-1 : valve which is closed automatically when the pump is not activated. Used to isolate the system
and to prevent any possible inlet from the exhaust connector at the rear, through the pump into the cassette
when the pump is not activated.
Vacuum to 18O water valve (valve 1-21) : connects the waste bottle to the 18O-Water recovery fitting on
the front. Sets the 18O-Water recovery vial to vacuum.
Electronic vacuum gauge
Solid state relay : provides power (220 Vac) to the heater.
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A few seconds later you will reach the About window showing a picture of the TRACERlab MX FDG and
program version information. This window can be reopened anytime by pressing the About tab at the top of
the window.
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Direction 2335256-100
At this stage, the TRACERlab MX FDG is in stand-by mode, i.e. in safe mode, with all output de-energized. The
general layout of the main window consists of a set of sub-windows accessible through tabs : About, Maintenance,
Synthesis, Report, Trending and Calibration. According to the status of the TRACERlab MX FDG, some tabs are
deactivated by the system, restricting access to the corresponding view.
In the case where the TRACERlab MX FDG is not powered up or not connected to the PC, the following error
indicator will be displayed in the bottom right-hand corner of the About window.
As long as the supervision program is running, the link to the TRACERlab MX FDG unit is continuously monitored.
Should a fault condition occur, the About window will pop-up, indicating that the PLC is not powered up, or
not connected to the PC.
Click on the Set to maintenance mode button in the lower left-hand corner. This will open the Maintenance
window.
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The only actuator which can turn in both directions is the second one from the left side, which is located below
the anion exchange cartridge of the cassette. To activate this rotating actuator, click on the corresponding rotating
valve as displayed on the screen. Then the valve position dialog box will be opened, allowing the actuator to
be turned either to the right, or to the left.
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Kit exhaust valve (normally closed) : valve allowing to drain the waste fluids to the external waste bottle and
to set the kit, i.e. the cassette, to vacuum.
Click on the corresponding symbol on the screen to open or close a valve. The valve is displayed in red when
closed and in green when open, e.g. the picture below shows the display on the screen when the HF valve is
opened and the LF valve remains closed.
2. Enter the chosen position in the setpoint field of the corresponding position dialog box.
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The temperature measurements are monitored and displayed graphically versus time in the temperature trending
window accessible through the Trending tab in the top part of the screen.
The vacuum measurements are monitored and displayed graphically versus time in the pressure trending window
accessible through the Trending tab in the top part of the screen.
Note :
These pressure dialog boxes can be used to perform leak tests in the maintenance mode: for example, one can
check if there is a leak on the waste bottle cap or on the enriched 18O-water recovery vial cap as follows:
1. Waste bottle leak test :
Choose a vacuum setpoint of 0.6 bars in the Pressure dialog box. After a few seconds the setpoint is reached.
If there is a leak on the waste bottle cap or the connections and tubes leading to the waste bottle there will be
a drop in the measured vacuum and the pump will start again after a few seconds. A drop in vacuum of up to
0.003
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Direction 2335256-100
0.003 bars per sec is not significant and the synthesis will not be affected. Note that the kit test (i.e. the cassette
test) performed before an FDG synthesis will detect leak drops above 0.001 bars per sec
2. Enriched water recovery vial leak test :
For this test, the enriched 18O-water recovery vial has to be connected to a cassette or the connector used to
connect this vial to the cassette has to be blocked. Connect the water recovery vial to the waste bottle by opening
the Vacuum 18O water valve. Choose a vacuum setpoint of 0.6 bars in the Pressure dialog box. After a few
seconds the setpoint is reached. If there is a leak on the enriched 18O-water recovery vial cap, on the waste bottle
cap, or on the connections and tubes leading to the waste bottle or the 18O-water recovery vial, there will be a
drop in the measured vacuum and the pump will start again after a few seconds. A drop in vacuum of up to 0.003
bars per sec is not significant and the synthesis will not be affected. Note that the kit test (i.e. the cassette test)
performed before an FDG synthesis will detect leak drops above 0.001 bars per sec.
7. Operation of the clamps holding the cassette in place
The pneumatic clamps holding the cassette in place can be activated and deactivated through the Clamp Kit
button.
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Chapter 7 : Calibration of
the activity detectors
The four activity detectors can be calibrated using the Calibration window accessible in the maintenance mode
through the corresponding tab at the top of the screen.
Note that the accuracy of the activity measurements through these built-in detectors is about 10 %.
The calibration is made by adjustment of the calibration parameter named Slope. The slope is the ratio between
the digital electrical output level of the detector and the correct radioactivity level. (The digital detector signal is
16 bit, per mCi). For this reason, if you increase the Slope, the displayed value will decrease, e.g. if you multiply
the slope by a factor of 2, the activity measurement given by the detector will be divided by 2.
The calibration of the detectors is carried out through a comparison of the activity reading given by the builtin detector and the effective activity in front of the detector. A dose calibrator providing accurate activity
measurements is needed for the calibration.
There are two ways to calibrate the detectors : Routine calibration and Manual calibration
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3. If the calibration of the detector is made using a routine FDG production run, it is necessary to accurately
measure the activity in the final product vial using a dose calibrator before release of the FDG solution for
medical use. Write down the effective activity in the final product vial and the time of measurement.
4. After sufficient decay, after reaching a radiation level below the limits given by applicable radiation safety
regulations, remove the cassette from the TRACERlab MX FDG and dismantle the cassette. Use protective gloves
while handling the contaminated cassette.
5. Measure the residual activity on the following items and write down the measured activity and time of
measurement : FDG final product vial, external waste bottle, enriched water recovery vial, conical reservoir,
QMA cartridge (blue ring), hydrolysis tC18 cartridge (red ring), purification tC18 cartridge (red ring), alumina
N cartridge (green ring), reactor vessel with cap and tubes, tube leading to the final product vial and filter,
Manifold 1 with fittings, Manifold 2 with fittings, Manifold 3 with fittings and the two 30 ml syringes.
6. Set the TRACERLab MX FDG to the Maintenance mode
7. Open the Calibration window through the tab at the top of the screen.
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8. Proceed with step 1 (box in the upper left-hand corner) : get the time at the start of synthesis and the activity
measurements taken by the built-in detectors during the hot run by pressing the Get values from last synthesis
button. Note that these values can also be taken from the synthesis report and be introduced manually, for
example when another FDG production has been carried out after the run carried out for calibration purpose.
Press the Next button to proceed.
9. Proceed with step 2 (box on the right-hand side) : fill in the fields with the activity measurement on each item
and the time of measurement. Press the Next button to proceed.
The most important activity measurements are the ten first items listed above. If you omit to measure the
residual activity on some items, put a 0 activity level in the corresponding Radioactivity field and fill in
the time of measurement field with a random time. Omitting some activity measurements might lead to a
lower accuracy of calibration.
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Direction 2335256-100
10. Proceed with step 3 (box in the lower left-hand corner) : the box now displays the current slopes for the four
detectors and the new slopes calculated using the activity measurements. It is recommended that a record of
both values is kept in your internal files relating to the TRACERlab MX FDG.
11. Transfer the new slope values to the TRACERlab MX FDG by pressing the Transfer values to synthesizer
button. As soon as the transfer is finished the current slope will be replaced by the new slope in the
corresponding fields of the Step 3 box.
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Direction 2335256-100
allow for comparison, both activity measurements have to be corrected for decay using the same reference time.
The slope can be adjusted by multiplying the current slope by a corrective factor, which is the ratio between the
activity measurement given by the detector of the TRACERlab MX FDG (corrected for decay) and the activity
measurement on the relevant cassette component given by a dose calibrator (corrected for decay).
Note that the activity detectors are very sensitive to the geometry of the radioactive source, Therefore they have
to be calibrated with the same geometrical distribution of radioactivity as during a FDG synthesis. To allow for
an accurate manual calibration, it is recommended that a hot synthesis is performed, to abort the synthesis as soon
as the activity is on the relevant cassette component in front of the detector to be calibrated and to measure the
activity on the relevant cassette component after sufficient decay :
- For detector 1 : abort the synthesis after the trapping of the 18F onto the anion exchange (QMA) cartridge.
- For detector 2 : abort the synthesis after evaporation of the solvents, just before the labeling step.
- For detector 3 : abort the synthesis after the trapping of the labeled intermediate onto the tC18 cartridge, just
before the hydrolysis step.
- For detector 4 : abort the synthesis after the transfer of the FDG solution into the final product vial.
Example :
With a slope of 6.35, the detector behind the QMA cartridge gives an activity measurement of 856 mCi, after
the trapping of 18F onto the cartridge at 5:03. The decay-corrected activity (reference time = start of synthesis i.e.
5:00) is 872 mCi.
After the trapping of the 18F onto the QMA cartridge, the synthesis is aborted and the activity on the QMA
cartridge is measured after sufficient decay. The activity measured on the QMA cartridge is 4.892 mCi at 19:14
i.e. 1063 mCi corrected for decay to the reference time.
Thus the corrective factor is 0.82 (i.e. 872/1063) and the adjusted slope is -5.21 (i.e. 6.35 * 0.82)
Proceed as follows to transfer new estimated slopes into the TRACERlab MX FDG:
1. Set the TRACERlab MX FDG to the Maintenance mode
2. Open the Calibration window through the tab at the top of the screen.
3. The current slopes for the four detectors are displayed in the Step 3 box (lower left-hand corner). Take these
values to estimate new slopes as described above.
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Direction 2335256-100
4. Click on the Manu button to switch to the manual calibration mode and new fields will appear allowing the
entering of the new slopes. Enter the new slopes. If some slopes are not modified, the current slope value must
be copied in the field designated for the new slopes. It is recommended that a record of both values is kept in
your internal files relating to the TRACERlab MX FDG.
5. When all the new slope fields have been filled in, the Transfer values to synthesizer button becomes
accessible, and the values can be transferred to the TRACERlab MX FDG.
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The following Radioactivity detectors window is displayed :
The offset values should normally range between 26000 and 31000.
The offset may be out of range if :
- Zero calibration of all detectors was performed while activity was still present
- detector wiring fault
- non a standard detector.
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FDG
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(Ordering reference : 2333437). Take care not to confuse the waste connections at the rear of the TRACERlab MX
: the waste tubes have to be connected onto the From Waste and onto the To Waste connectors.
FDG
Important notes :
The waste tube may be contaminated with radioactive compounds. Use protective gloves while replacing the
silicone tube. Store the used tube behind shielding until sufficient decay and discard it in compliance with local
radioprotection regulations.
Replace the tube as soon as leaks are detected systematically during the kit test. The waste cap may age, leading
to leaks. If evidences of aging are noticed on the cap and tube, it is recommended to replace these items.
1-15
1-16
1-17
1-23
1-18
1-20
1-19
2-5
2-3
1-21
2-1
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Direction 2335256-100
Set the pump to a vacuum level of 0.4 bar. An increasing vacuum level measured by the electronic vacuum
gauge (value displayed on the screen) and a gas flow at the exhaust connection at the rear of the synthesizer
indicates that the valve is working properly. If defective, contact the supplier or manufacturer of the equipment.
After the test, release the vacuum in the waste bottle as follows : reset all the outputs, open the kit exhaust valve
until the vacuum level as displayed on the screen is around 0 and close the kit exhaust valve.
Connect the external vacuometer onto the exhaust connection on the right side of the front panel. Using the
maintenance mode, set the waste bottle to increasing vacuum levels (for example -0.3 , -0.5 and 0.7 bars), open
the kit exhaust valve (valve 1-24) and compare the value displayed on the screen with the value given by the
external vacuometer. The difference between both values should be lower than 0.05 bar. In the case of a drift of
the electronic measurement, adjust the value using the built-in potentiometer as described below. In the case of a
defective vacuum gauge or vacuum potentiometer, replace the worn part as described in the relevant procedure
(MR-001-006 in the appendix)
Adjustment of the vacuum measurement in the case of a drift :
The vacuum measurement can be adjusted using the screw located in the hole below the mechanical vacuometer
on the front panel. The adjustment is made by comparing the vacuum level displayed on the screen and the
vacuum measured using an external, accurate and calibrated vacuometer.
1. Turn the screw of the potentiometer completely clockwise using a 2 mm flat-headed screwdriver.
2. Set the waste bottle to vacuum (setpoint of at least 0.6 bar). The pump will continue running until reaching
the setpoint according to the measurement displayed on the screen. The effective vacuum as given by the
reference vacuometer will be lower.
3. Gently turn the screw of the potentiometer anticlockwise until the vacuum level displayed on the screen
matches the vacuum level given by the reference vacuometer. The pump will start each time you turn the
screw.
4. If you turn the screw too fast you might reach a higher vacuum on the reference vacuometer. If this happens,
turn the screw of the potentiometer a little bit clockwise, open the waste bottle cap and close it again. Adjust
the vacuum again, as explained above.
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Direction 2335256-100
5. The vacuum displayed on the screen should match the vacuum given by the reference vacuometer, with a
tolerance of 0.05 bar
The electronic vacuum gauge can also be checked using the built-in mechanical vacuometer on the front panel
of the synthesizer. Note that the accuracy of this vacuometer is limited. If the check is made using the front
panel vacuometer, do not open the kit exhaust valve.
After the test, release the vacuum in the waste bottle as follows : reset all the outputs, disconnect the external
vacuometer from the exhaust connector, open the kit exhaust valve until the vacuum level as displayed on
the screen is around 0 and close the kit exhaust valve.
Using the maintenance mode set the waste bottle to a vacuum level of 0.8 bar. Using a standard 250 ml waste
bottle, this vacuum level should be reached within 1 minute. Set the setpoint to 0 and follow the value of the
vacuum displayed on the screen. The vacuum drop should be lower than 0.001 bar per second. A weak pump
has to be replaced preventively according to the procedure MR-001-008 in the appendix. Note that leaks in the
internal tubing of the synthesizer may also lead to an extension of the time required to reach the vacuum and
to a vacuum drop after reaching the setpoint. In case of a leak in the internal tubing, contact the supplier or
manufacturer of the equipment.
After the test, release the vacuum in the waste bottle as follows : reset all the outputs, open the kit exhaust valve
until the vacuum level as displayed on the screen is around 0 and close the kit exhaust valve.
4.4 Checking the high flow-rate, the HF valve (valve 1-19) and the nitrogen
valve (valve 2-5)
Connect the 0-50 ml flow-meter onto the pressure inlet connection (where the cassette inlet tube on the left
hand side is connected for the FDG synthesis). Verify that there is no gas flow when the HF valve (valve 1-19)
is not activated (default status in the maintenance mode). A flow noticed while the valve is closed indicates that
there is a leak either through the HF valve, either through the LF valve. Replace the valves one by one as
described in the procedure MR-001-015 (see appendix) and check if there is no more leak.
Connect the 0-1000 ml flow-meter onto the pressure inlet connection and open the HF valve (valve 1-19).
The measured flow-rate should be in the range between 300 and 600 ml/min. If the flow-rate is out of this range
contact the supplier or manufacturer of the equipment. If the valve is defective, replace it as described in the
procedure MR-001-015 (see appendix).
If there is no nitrogen flow at all while opening the HF valve and the LF (see below), this indicates that
the main nitrogen supply valve, i.e. the nitrogen valve (valve 2-5) may be defective. Contact the supplier or
manufacturer of the equipment.
Note : in the case another inert gas than nitrogen is used (e.g. helium) the flow rates may be out of range. Do not
use other gases than nitrogen
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4.5 Checking the low flow-rate, LF valve (valve 1-20), and the nitrogen valve
(valve 2-5)
Connect the 0-50 ml f low-meter onto the pressure inlet connection (where the cassette inlet tube on the left
hand side is connected for the FDG synthesis). Verify that there is no gas flow when the LF valve (valve 1-20)
is not activated (default status in the maintenance mode). A flow noticed while the valve is closed indicates that
there is a leak either through the LF valve, either through the HF valve. Replace the valves one by one as
described in the procedure MR-001-015 (see appendix) and check if there is no more leak.
Leave the 0-50 ml flow-meter connected onto the pressure inlet connection and open the LF valve (valve
1-20). The measured flow-rate should be in the range between 25 and 45 ml/min. If the flow-rate is out of this
range contact the supplier or manufacturer of the equipment. If the valve is defective, replace it as described in
the procedure MR-001-015 (see appendix).
If there is no nitrogen flow at all while opening the LF valve and the HF (see above), this indicates that
the main nitrogen supply valve, i.e. the nitrogen valve (valve 2-5) may be defective. Contact the supplier or
manufacturer of the equipment.
Note : in the case another inert gas than nitrogen is used (e.g. helium) the flow rates may be out of range. Do not
use other gases than nitrogen.
4.6 Checking the low pressure level and the LP valve (valve 1-23)
Connect the 0-50 ml flow-meter onto the connection on the front panel where the white elution system is connected
(do not confuse it with the activity inlet connection on the pinch valve). Verify that there is no gas flow when the
LP valve (valve 1-23) is not activated (default status in the maintenance mode). A flow noticed while the valve
is closed indicates that there is a leak either through the LP valve, either through the HP valve. Replace the
valves one by one as described in the procedure MR-001-015 (see appendix) and check if there is no more leak.
Connect the manometer onto the connection on the front panel where the white elution system is connected.
Open the LP valve (valve 1-23). The pressure level should be in the range between 0.35 and 0.5 bars. If the
pressure level is out of this range, adjust it as described in the procedure MR-001-012 (see appendix). If the valve
is defective, replace it as described in the procedure MR-001-015 (see appendix).
4.7 Checking the high pressure level and the HP valve (valve 1-18)
Connect the 0-50 ml flow-meter onto the connection on the front panel where the white elution system is connected
(do not confuse it with the activity inlet connection on the pinch valve). Verify that there is no gas flow when the
HP valve (valve 1-23) is not activated (default status in the maintenance mode). A flow noticed while the valve
is closed indicates that there is a leak either through the HP valve, either through the LP valve. Replace the
valves one by one as described in the procedure MR-001-015 (see appendix) and check if there is no more leak.
Connect the manometer onto the connection on the front panel where the white elution system is connected. Open
the HP valve (valve 1-18). The pressure level should be in the range between 0.6 and 0.8 bars. If the pressure
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Direction 2335256-100
level is out of this range, adjust it as described in the procedure MR-001-012 (see appendix). Note that changing
the pressure level will have an effect on the LF and HF flow-rates (see relevant sections above). If the valve is
defective, replace it as described in the procedure MR-001-015 (see appendix).
Set the waste bottle to vacuum (for example -0.8 bars). Open the Vac valve (valve 1-17), air will flow into the
waste bottle and the pump will start to maintain vacuum. If the valve is defective, replace it as described in the
procedure MR-001-015 (see appendix).
Set the waste bottle to vacuum (for example -0.8 bars). Open the Vacuum to 18O water valve (valve 1-21), air
will flow into the waste bottle and the pump will start to maintain vacuum. If the valve is defective replace it as
described in the procedure MR-001-015 (see appendix).
Set the waste bottle to vacuum (for example -0.8 bars). Open the kit exhaust valve (valve 1-24), air will flow
into the waste bottle and the pump will start to maintain vacuum. If the valve is defective, replace it as described
in the procedure MR-001-015 (see appendix).
Connect a cassette onto the synthesizer but without reagent vials. A used cassette can be taken for this purpose.
Clamp the cassette, close the 18F inlet valve and open the Vac valve. Set the waste bottle to vacuum (for
example -0.8 bars). Open the eluent valve (valve 1-15), air will flow into the waste bottle and the pump will
start to maintain vacuum. If the valve is defective, replace the elution system as described in the procedure
MR-001-005 (see appendix).
Visually checking the valve : activate the 18F inlet valve (valve 1-16) and look to see if the silicone tube is
pinched properly. If the valve is defective, replace it as described in the procedure MR-001-016 (see appendix).
Take a reaction vial from a used cassette, remove the cap, fill the vial with 3 ml of water and place it into the heater.
Set the heater to a temperature of 30 C. After stabilisation of the temperature, set it to 80C. The temperature of
80C should be reached within 60 sec on the screen. Wait for at least 3 minutes before measuring the temperature
of the water using an external thermometer. A difference of 5C between the measured temperature and the
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Direction 2335256-100
temperature displayed on the screen is acceptable. If the heater or the thermocouple is defective, contact the
supplier or manufacturer of the equipment.
Visually checking the syringe drivers : actuate the 3 syringe drivers and verify if they move properly (moving 10
mm within 8 sec for the 30 ml syringe drivers and moving 10 mm within 12 seconds for the 3 ml syringe driver) .
There is no need for high accuracy regarding the position of the two 30 ml syringe drivers but the position of the
3 ml syringe driver should be checked as described below. For the 30 ml syringe drivers there should be no more
than 2 ml of air left in the syringe when the syringe driver is in the 3 mm position. If one of the syringe drivers is
defective, replace it as described in the procedure MR-001-009 or MR-001-010 (see appendix).
Connect a cassette onto the synthesizer, but without reagents. A used cassette can be taken for this purpose. Fill
a 3 ml syringe (as used for the reagents), with 1 ml of water and connect it onto the corresponding position of the
cassette. Actuate the rotating actuator below the syringe and the third actuator of the right hand manifold. Set
the syringe driver to the 7 mm position. The volume injected into the hydrolysis cartridge should be in the range
between 700 and 800 l (between 200 and 300 l left in the syringe). In the case where the position of the 3 ml
syringe driver has to be adjusted, refer to the procedure MR-001-010 in the appendix.
4.16 Checking the rotating actuators and the Compressed air valve (valve 2-3)
Visually checking the rotating actuators, rotation within 1 sec. Note that a slow rotation or no movement at all is
generally due to an insufficient compressed air pressure level.
actuator 1 :
actuator 2 :
actuator 3 :
actuator 4 :
actuator 5 :
actuator 6 :
actuator 7 :
actuator 8 :
actuator 9 :
actuator 10 :
actuator 11 :
actuator 12 :
actuator 13:
actuator 14 :
actuator 15 :
90 right
90 left and right
90 right
90 right
90 right
90 left
90 left
90 right
90 right
90 right
90 right
90 left
90 right
90 left
90 right
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In the case of a defective rotating actuator, contact the supplier or manufacturer of the equipment.
If the rotating actuators and the clamp mechanism cannot be activated (see below), this indicates that the main
compressed air supply valve, i.e. the Compressed air (valve 2-3) may be defective. Contact the supplier or
manufacturer of the equipment.
4.17 Checking the clamp kit mechanism and the Compressed air valve (valve 2-3)
Visually checking the clamp kit (clamp cassette) mechanism : activate the mechanism by pressing the clamp
button on the front panel and check that the elution mechanism moves down, and that the clamps move out of
the front. Note that a slow movement of this mechanism or no movement at all is generally due to an insufficient
compressed air pressure level.
If the clamp mechanism and the rotating actuators cannot be activated (see above), this indicates that the main
compressed air supply valve, i.e. the Compressed air (valve 2-3) may be defective. Contact the supplier or
manufacturer of the equipment.
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Checklist
Proper functioning of the TRACERlab MXFDG
The tube from the eluent pinch valve has been replaced
The tube from the 18F inlet pinch valve has been replaced
The waste bottle cap and its tubes with connectors have been replaced
The valve connected to the pump (valve 2-1) is operating properly
The vacuum measurements were checked and the following values have been measured
The vacuum pump is working properly and a 0.8 bar vacuum level has been reached within _____sec
The nitrogen valve (valve 2-5) is operating properly
The HF valve (valve 1-19) is operating properly
The high flow (HF) gas flow-rate is _____ ml/min (between 300 and 600 ml/min)
The LF valve (valve 1-20) is operating properly
The low flow (LF) gas flow-rate is _____ ml/min (between 25 and 45 ml/min)
The LP valve (valve 1-23) is operating properly
The low pressure (LP) gas pressure level is _____ bar (between 0.35 and 0.5 bar)
The HP valve (valve 1-18) is operating properly
The high pressure (HP) gas pressure level is _____ bar (between 0.6 and 0.8 bar)
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Chapter 12 : Troubleshooting
Important note :
The reference TRACERlab MX FDG system is the synthesizer loaded with the standard synthesis sequence
supplied by GE. Any other customized sequences might have different specification and operation process
and are not supported by GE.
This chapter and the chapter specifically about the report analysis are complementary. Refer to the Yearly
maintenance chapter for more details concerning the checking of the components of the TRACERlab MX FDG
through the maintenance mode.
An error in the heater may be due to a malfunctioning of the heating resistance, to a malfunctioning of the
thermocouple, to a malfunctioning of the solid state relay or to a blown heater fuse. To identify which component is
defective, set the TRACERlab MX FDG to the maintenance mode and operate the heater by entering a temperature
setpoint. If the temperature measurement as displayed on the screen makes no sense, the heater error may be
related to a defective thermocouple. If the heating element does not heat up at all, and the temperature measurement
as displayed on the screen remains at room temperature, the heater error may be related to a defective heating
resistance, or a defective solid state relay or a blown fuse. If the solid state relay is defective, the heater may heat
up above the setpoint or not heat up at all, depending on the status of the solid state relay; but the temperature
measurement as displayed on the screen reflects the effective temperature of the heating element. The fuse can
be replaced as described in the procedure of the appendix. In the case of a malfunctioning heating resistance,
thermocouple or solid state relay, contact the supplier or manufacturer of the equipment.
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1.2 Syringe actuator error
In the case of an error detected on a syringe driver, replace the syringe driver according to the procedures given in the
appendix. See also the relevant section below.
The compressed air pressure level is checked through a pressure switch adjusted to detect the presence of at least 3.5
bar. If the compressed air pressure level is lower than 3.5 bar, the operator is informed by means of a red signal in the
Synthesizer Test box in order to allow corrective action, e.g. restore compressed air supply.
In the case of a compressed air error, check the main compressed air supply, and check the lines and valves supplying
compressed air to the TRACERlab MX FDG. If no abnormality is detected, check the Compressed air valve of the
TRACERlab MX FDG in the maintenance mode, as described in the Yearly maintenance section of this manual. In the
case of a defective Compressed air valve, contact the supplier or manufacturer of the equipment.
If the compressed air supply pressure level is high enough (> 6 bars) and if all pneumatic components are working
properly (i.e. the rotating actuators, the clamps and the movement of the elution system down onto the reservoir), then
the compressed air error may be related to a defective pressure switch. In the case of a defective pressure switch contact
the supplier or manufacturer of the equipment.
The nitrogen pressure level is checked through a pressure switch adjusted to detect the presence of at least 1.5 bar. If the
nitrogen pressure level is lower than 1.5 bar, the operator is informed by means of a red signal in the Synthesizer Test
box in order to allow corrective action, e.g. restore nitrogen supply.
In the case of a nitrogen error, check the main nitrogen supply, and check the lines and valves supplying nitrogen to
the TRACERlab MX FDG. If no abnormality is detected, check the Nitrogen valve of the TRACERlab MX FDG in the
maintenance mode as described in the Yearly maintenance section of this manual. In the case of a defective Nitrogen
valve, contact the supplier or manufacturer of the equipment.
If the nitrogen supply pressure level is high enough (> 2 bars) and if the high pressure level (HP), the low pressure level
(LP), the high flow-rate (HF) and the low flow-rate (LF) are within the limits given in the Yearly maintenance section
of this manual, then the nitrogen error may be related to a defective pressure switch. In the case of a defective pressure
switch contact the supplier or manufacturer of the equipment.
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In the case of a syringe driver error, due to a blockage of the syringe by an
external factor (e.g. if the movement of a syringe filled with water is blocked
because the valve below the syringe is not opened) click on the relevant syringe
driver, and take corrective actions to avoid such a kind of failure in the future.
There are two switches on each syringe driver, used to detect the fact that the syringe driver has reached the upper
position or the lower position. Check the functioning of the syringe driver in the maintenance mode. If the syringe
error occurs only in the upper or lower position (92 mm or 0 mm setpoint), the malfunctioning may be due to an
inaccurate positioning of the switches. If the syringe error occurs each time the syringe driver is moved between
these limits, the malfunctioning may be due to a defective syringe driver card. If the syringe driver is defective,
replace the syringe driver according to the procedures given in the appendix.
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4. During synthesis an error message on the screen informs you that the pressure in the
waste bottle did not rise as expected
If the following window appears on the screen during the synthesis, this might be due to the absence of nitrogen.
Restore the nitrogen supply and click on OK to proceed with the synthesis.
5. Abnormality during the preliminary steps before the transfer of the irradiated water
5.1 The syringes are not hooked onto the syringe drivers
The transparent plastic cassette retainer was not placed. Thus the cassette was not properly hold in place.
The 30 ml syringes are of another brand than those recommended in the user manual (this may lead also to
changes in the final [18F] FDG solution volume).
The high pressure level is too low (< 0.6 bar). Adjust the pressure level according to the procedure given in the
appendix.
The spring in the syringe driver is weak. Replace the front piece of the syringe driver according to the procedure
given in the appendix.
There is no nitrogen supply.
The HF valve (valve 1-19) supplying nitrogen to the cassette is defective. Check this valve in the maintenance
mode as described in the Yearly maintenance section of this manual. In the case of a defective valve, replace
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the valve according to the procedure given in the appendix.
The reactor inlet or outlet tube is pinched by the clamps holding the cassette in place.
The reactor inlet line is obstructed for example because of the tube, plunging into the reactor vial, blocked
by resting on the bottom of the vial. Check the reactor inlet as follows : disconnect the reaction vial from the
cassette after the synthesis and try to send some water into the reaction vial through the inlet tube. Contact the
supplier of the cassettes in the case of an obstructed reactor inlet and provide the cassette lot number.
Either the acetonitrile spike or the triflate spike is obstructed by a piece of rubber from the stopper (this may
happen with another type of rubber other than the one recommended in the user manual).
With stoppers other than the one recommended in the user manual, leakages of liquid may happen through the
piercing hole.
5.3 The activity cannot be transferred from the target to the TRACERlab MX FDG
The line leading from the cyclotron to the TRACERlab MX FDG is blocked, for example by target impurities.
The tube for pressurizing/depressurizing of the reservoir (connection between the front panel of the synthesizer
and the elution system) is squeezed between the reservoir and the elution system.
If the irradiated water is sucked up from a vial using a needle plunging down to the bottom of the vial, transfer
problems from the vial into the reservoir can be caused by a missing vent on the vial, a blocked needle (either
because of impurities in the target water, or because the needle is bent too much), and by a too long and/or thin
tube leading from the vial to the inlet connection.
The Vac valve (valve 1-17) used to depressurize the reservoir is defective. Check this valve in the maintenance
mode as described in the Yearly maintenance section of this manual. In the case of a defective valve, replace
the valve according to the procedure given in the appendix.
6.1 The activity was not trapped properly onto the QMA cartridge and a large
amount of activity is in the enriched water recovery vial
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mixture is mixed up with the irradiated 18O water and the 18F cannot be fixed properly onto the cartridge. Check
the recovered 18O water for Kryptofix. If there is Kryptofix in the recovered 18O water, replace the silicone tube
of the pinch valve and if the valve is defective, replace the elution system as described in the procedure of the
appendix.
There are impurities in the irradiated 18O water : either target impurities, or impurities in the enriched 18O water
used for the irradiation (e.g. in the case where the enriched 18O water was not recycled/purified properly after
a former irradiation).
6.2 The activity was not trapped properly onto the QMA cartridge and the amount
of recovered 18O water is much lower than the target volume.
This happen when the irradiated water can not flow properly through the QMA cartridge, into the enriched water
recovery vial.
The tube for water recovery located on the first valve on the left of the stopcock manifold is squeezed between
the module and the cassette holder (transparent cassette retainer). In such a case, a part of the irradiated
18
O-water will not pass through the cartridge during the trapping step. The residual irradiated 18O-water will
stay in the reservoir and be mixed up with the eluent, leading to an incomplete evaporation and a bad overall
yield.
The QMA is blocked because of impurities coming out of the target. A dark residue might be noticed on the
QMA cartridge after the synthesis and some liquid left in the reservoir. In such a case, a part of the irradiated
18
O-water will not pass through the cartridge during the trapping step. The residual irradiated 18O-water will
stay in the reservoir and be mixed up with the eluent, leading to an incomplete evaporation and a bad overall
yield.
The QMA is defective (blocked cartridge). In this case the amount of recovered enriched water should be
abnormally low, or there is still some liquid in the reservoir above the cartridge after the synthesis (target water
mixed up with eluent).
The HP valve (valve 1-18) or the LP valve (valve 1-23) used to pressurize the reservoir is defective. Check
these valves in the maintenance mode as described in the Yearly maintenance section of this manual. In the
case of a defective valve, replace the valve according to the procedure given in the appendix.
The Vacuum to 18O water valve (valve 1-21) for the depressurizing of the enriched water recovery vial is
defective. Check this valve in the maintenance mode as described in the Yearly maintenance section of this
manual. In the case of a defective valve, replace the valve according to the procedure given in the appendix.
6.3 A large amount of activity remains trapped on the QMA cartridge after elution
and/or after synthesis
6.3.1 Some activity was sent to the reservoir after the start of the synthesis
When the synthesis is started after transfer of the irradiated 18O-water to the TRACERlab MX FDG, the 18F inlet
pinch valve is closed until the beginning of the evaporation step. Afterwards, the 18F inlet pinch valve is opened.
In the case where there is some irradiated 18O-water left in the lines leading to the TRACERlab MX FDG, this
residual activity will be sucked up into the reservoir, leading to an increase of the activity measured on the QMA
by the built-in detector, and to a high residual activity on the QMA cartridge after synthesis. Ensure that the
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whole amount of irradiated 18O-water has been sent to the TRACERlab MX FDG before starting the synthesis.
6.3.2 The eluent was not transferred properly from its vial into the reservoir
Verify that the eluent vial is empty after the synthesis and that there are no leaks in the elution system.
The silicone tube of the eluent pinch valve remains pinched where it has been placed in the pinch valve.
Replace the tube as described in the procedure of the appendix. It is very important that this tube is replaced
weekly (see Weekly maintenance section of this manual). Furthermore, this tube has to be moved by a few
mm within the valve before each run to avoid such a kind of problem.
The internal fluid pathway of the elution system is obstructed by crystallized eluent. This may happen if the
system was not in use for long time. The obstruction may be located either in the two stainless steel connectors
on which the silicone tube of the eluent pinch valve is connected, either within the lower part of the elution
system. It is recommended to pass some water through the fluid pathway to clean the lines.
There is a leak on the connection at the front of the elution system (white nut), where the tube leading to the
activity inlet pinch valve is connected. This may happen after replacing this tube. In this case tighten the
connection. Note that such a leak is normally detected during the cassette test before synthesis.
The elution system inserts on the conical lower part of the elution system are damaged leading to an obstruction.
This may happen after replacement of these inserts according to procedure MR-001-004 in the appendix;
The eluent pinch valve (valve 1-15) is defective. Check this valve in the maintenance mode as described in
the Yearly maintenance section of this manual. In the case of a defective valve, replace the elution system
according to the procedure given in the appendix.
The spike on the elution system does not pierce the crimp cap of the eluent vial.
The vial is not crimped properly. There are leaks of liquid out of the vial when the vial is pressurized during
the synthesis.
There are leaks in the elution system. The eluent has leaked instead of being transferred into the reservoir.
Replace the elution system according to the procedure given in the appendix.
The tube for pressurizing/depressurizing of the reservoir (connection between the front panel of the synthesizer
and the elution system) is squeezed between the reservoir and the elution system, or disconnected.
The HP valve (valve 1-18) used to pressurize the reservoir at high pressure is defective. Check this valve
in the maintenance mode as described in the Yearly maintenance section of this manual. In the case of a
defective valve, replace the valve according to the procedure given in the appendix.
The Vac valve (valve 1-17) used to depressurize the reservoir is defective. Check this valve in the maintenance
mode as described in the Yearly maintenance section of this manual. In the case of a defective valve, replace
the valve according to the procedure given in the appendix.
6.3.3 The eluent was transferred into the reservoir but has not passed through the QMA
cartridge
Verify that there is no liquid (eluent) left in the reservoir after the synthesis.
The QMA cartridge has been blocked because of impurities coming out of the target. In such a case there is still
some liquid in the reservoir above the cartridge after the synthesis (irradiated 18O-water mixed with eluent). A
dark residue might be seen on the QMA cartridge after the synthesis.
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The QMA cartridge is defective (blocked cartridge). In such a case there might be some liquid in the reservoir
above the cartridge after the synthesis (irradiated 18O-water mixed with eluent).
The reactor inlet tube is squeezed between the front panel and the cassette holder (transparent cassette retainer)
or pinched by the clamps holding the cassette in place.
The reactor inlet line is obstructed for example because of the tube, plunging into the reactor vial, obstructed
by resting on the bottom of the vial. Check the reactor inlet as follows : disconnect the reaction vial from the
cassette after synthesis and try to send some water into the reaction vial through the inlet tube. Contact the
supplier of the cassette in the case of an obstructed reactor inlet and provide the cassette lot number.
There is a drift on the electronic vacuum gauge. The pressure given on the supervision screen is different than the
vacuum measurement given by the mechanical vacuum gauge on the front panel of the TRACERlab MX FDG, or by
an external vacuometer. In the case of a drift on the electronic vacuum gauge, adjust the vacuum measurement
as described in the Yearly maintenance section of this manual.
6.3.4 The eluent has passed through the QMA cartridge but the activity has not been eluted.
The amount, or composition, of the eluent mixture is not right (for example there is no K 2CO3 in the mixture).
6.4 The activity was not trapped properly on the tC18 cartridge before hydrolysis.
An important fraction of the activity of the labeling solution has not been trapped on the hydrolysis tC18
cartridge.
To identify the origin of the problem, analyze the content of the waste bottle after a hot synthesis by Thin Layer
Chromatography (TLC) or by HPLC with a radioHPLC-detector.
6.4.1 The main part of the activity in the waste bottle is in 18F- form
The mannose triflate precursor was not properly labeled; the main fraction of the activity is still in the 18F- form
after labeling and is not retained on the tC18 cartridge. This happens when the Kryptofix / 18F- complex is not dry
after the evaporation process or if there are impurities in the system leading to a bad labeling yield.
Note that a poor labeling yield is the most frequent reason for an overall EOS yield below 45%
The amount or quality of the reagents is not correct :
- Impurities or moisture in the nitrogen
- Impurities or moisture in the mannose triflate precursor
- Impurities or moisture in the acetonitrile
- Impurities in the eluent, too much water in the mixture
- Impurities coming from the QMA cartridge due to the conditioning of the cartridge (impurities in the reagents
used for the conditioning, impurities in the gas used to dry the cartridge,)
The reagents were contaminated with impurities or moisture during the conditioning in the reagent vials :
contamination of the vials, contamination of the micropipette,
The reagents were not stored properly, e.g. the mannose triflate degrades if stocked at room temperature.
If mannose triflate precursor from a bulk stock kept in the freezer is used, allow the precursor to reach room
temperature before opening the stock vial and packaging the amount for one synthesis in the color coded vial.
If a frozen vial is opened, moisture may condense in the vial and contaminate the mannose triflate precursor.
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It is recommended that the reagents are only used for [18F] FDG productions and not used for other purposes,
in order to reduce the risk of contamination of the whole reagent stock.
The cassette or the reagents vials were handled with wet hands (water, isopropanol, ethanol,..) or were
contaminated during mounting on the TRACERlab MX FDG.
The internal nitrogen lines leading from the HF valve and the LF valve to the cassette, have been
contaminated with moisture or other impurities. This may happen when compressed air is supplied instead of
clean and dry nitrogen, or when a synthesis was aborted during the process (in such a case some liquid might
flow into the kit inlet connector on the front panel). Purge the internal lines with clean nitrogen by opening
the HF valve and the LF valve in the maintenance mode for at least 30 minutes. Note concerning the
maintenance mode : the TRACERlab MX FDG will be set automatically to the stand-by mode if there is no
user intervention during 15 minutes. In the case where the internal nitrogen lines are contaminated with an
impurity which cannot be evacuated by a nitrogen purge, these lines have to be replaced. Contact the supplier
or manufacturer of the equipment in the case where internal tubing have to be replaced.
There is contamination with isopropanol. This may happen when isopropanol is used to sterilize the
synthesizer, or the cassette, before synthesis.
There is a substantial amount of impurities (from the target) in the irradiated 18O water. Dark residues may be
noticed on the QMA cartridge after the synthesis.
The reactor inlet or outlet tube is (partially) squeezed by the clamps holding the cassette in place or by the
transparent cassette retainer. One of the other silicone tubes from the cassette is (partially) squeezed.
The reactor inlet line is partially obstructed for example because of the tube, plunging into the reaction vial,
is blocked by resting on the bottom of the vial. Check the reactor inlet as follows : disconnect the reaction vial
from the cassette after the synthesis and try sending some water into the reaction vial through the inlet tube.
Contact the supplier of the cassette in case of an obstructed reactor inlet and provide the cassette lot number.
The nitrogen flow entering the cassette is too low. Check the flow-rates as described in the Yearly maintenance
section of the this manual. If the flow-rates are out of range contact the supplier or manufacturer of the
cassette.
Another inert gas than nitrogen is used
The temperature in the heater doesnt reach the setpoint. Check the heater as described in the Yearly
maintenance section of this manual. If the heater doesnt work properly, contact the supplier or manufacturer
of the cassette.
There is a leak in the waste bottle connections (this is normally detected during the cassette test before synthesis).
Check the waste cap as described in the Maintenance mode section of this manual. If needed, replace the
waste cap.
If a waste bottle with a larger volume than the one recommended in the user manual is used, replace it with a
250 ml bottle. The time needed to reach a vacuum setpoint is dependent on the waste bottle volume.
The bottom of the reactor vial is not in contact with the bottom of the heater, leading to a poor heat transfer and
incomplete evaporation.
The mannose triflate precursor dissolved in acetonitrile leaked away from ist vial and was therefore not
transferred into the reaction vessel. With stoppers other than the one recommended in the user manual, leakages
of reagent may happen through the piercing hole.
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6.4.2 There is a large amount of [18F]-2-18FFluro-1,3,4,6-tetra-O-acetyl-Dglucose ([18F]-TAFg) (up to 50 %) in the waste bottles.
One possible explanation is that the mannose triflate precursor was well labeled, but the labeled compound ([18F]TAFg) was not trapped on the tC18 cartridge. This may happen if the labeled solution was mixed up with a too
small a quantity of water before the trapping onto the cartridge. The [18F]-TAFg is not retained on the cartridge
and the labeled compound will be found in the waste bottle.
There is no water bag, the water bag is not connected properly to the cassette and/or the water is not properly
sucked up into the 30 ml syringe. This would also lead to a lower amount of FDG solution in the final vial and
may have an effect on the pH.
If a rigid (glass) water bottle is used, it should be properly vented. If a rigid water bottle is not vented, or if the
venting needle is obstructed (for example, the needle bent too much), water cannot be taken up properly from
the bottle. This would also lead to a lower amount of FDG solution in the final vial and may have an effect on
the pH.
The tC18 cartridge used for the hydrolysis is defective, or not adequately filled with resin (this happens very
rarely). Analyze the cartridge after synthesis : pass some water through the cartridge and check if the flow-rate
through the cartridge is abnormally high, i.e. if the backpressure is abnormally low.
6.5 The hydrolysis tC18 cartridge became blocked during the trapping of the labeled
precursor or during the rinsing steps before hydrolysis, leading to liquid leaks.
A mannose triflate precursor of poor quality, or stored under bad conditions, can lead to a (partial) obstruction
of the tC18 cartridge when the labeled precursor is trapped on the cartridge after labeling. This leads generally to
liquid leaks in the silicone connection between the left hand manifold and the central manifold, a poor hydrolysis
yield, a lower volume in the final vial, a pH out of range, and a bad overall yield.
6.6. The activity is not eluted out of the tC18 cartridge after hydrolysis.
The hydrolysis reaction is incomplete
The main part of the labeled solution has been trapped on the hydrolysis tC18 cartridge but was not eluted out of
the cartridge after hydrolysis. The activity was washed out of the cassette, into the waste bottle during the rinsing
steps after the synthesis.
Analyze the contents of the waste bottle after the synthesis and the rinsing steps by Thin Layer Chromatography
(TLC) or by HPLC with a radioHPLC-detector. If an important part of the activity in the waste bottle (up to 50
%) is [18F]-2-18FFluro-1,3,4,6-tetra-O-acetyl-D-glucose ([18F]-TAFg) or [18F]-FDG, the problem is probably related
to a poor hydrolysis yield.
The mannose triflate precursor was well labeled and the labeled compound ([18F]-TAFg) was trapped properly on
the tC18 cartridge, but the labeled compound was not hydrolyzed properly. The [18F]-TAFg was not converted into
[18F] FDG (or converted only partially) and the activity could not be eluted out of the cartridge, into the syringe
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where the solution is neutralized. The activity (or an important part of it) will stay on the tC18 cartridge until the
end of the synthesis and will be washed out to the waste bottle during the rinsing steps.
Note that the [18F]-TAFg washed out of the tC18 cartridge, may be converted to [18F]-FDG within the waste bottle
after synthesis, due to the presence of some sodium hydroxide.
If the hydrolysis reaction is incomplete this may also lead to an abnormal high amount of partially hydrolyzed
compounds in the FDG solution, i.e. abnormally high amount of radiochemical impurities other than 18F- ions.
There is no sodium hydroxide syringe, or the syringe is not screwed correctly onto the cassette.
The molarity of the sodium hydroxide is much too low. This will also lead to a pH that is too low.
The tC18 cartridge was obstructed because of a mannose triflate precursor of poor quality (cf. above).
Some sodium hydroxide leaked away below the position of the sodium hydroxide syringe.
This may happen if the syringe is screwed too loosely or too strongly onto the cassette.
Some sodium hydroxide leaked away below the position of the tC18 cartridge used for hydrolysis.
This may be related to a non-conformity of the cassette. Please contact the supplier of the cassettes.
6.7. Some activity trapped onto the tC18 cartridge is lost during hydrolysis
Some sodium hydroxide leaked away below the position of the tC18 cartridge used for hydrolysis. This may be
related to a non-conformity of the cassette. Please contact the supplier of the cassettes.
7. Fluctuating yields
The reagents are not prepared, or the QMA cartridges are not conditioned ahead of time for several [18F]-FDG
productions but every day just before the synthesis. This may lead to yield fluctuation due to slight differences
during preparation (contamination with moisture or other impurities). Preparing all the reagent and the QMA
cartridges for several syntheses at once, under clean conditions, reduces the risk of fluctuating yields.
Isopropanol is used to sterilize the hot cell. Accidental contamination of the cassette and/or the reagents may
lead to yield fluctuation.
8. There is no liquid in the final vial, the volume of FDG solution is abnormally low or
the volume of FDG solution is fluctuating from run to run
There is no water bag, the water bag is not connected properly to the cassette and/or the water is not properly
sucked up into the 30 ml syringe. This may also lead to a poor trapping efficiency of the labeled compound
([18F]-TAFg) onto the tC18 cartridge (see relevant section above).
If a rigid (glass) water bottle is used, it should be properly vented. If a rigid water bottle is not vented or if the
venting needle is obstructed (for example, the needle bent too much), water cannot be taken up properly from
the bottle. This may also lead to a poor trapping efficiency of the labeled compound ([18F]-TAFg) onto the tC18
cartridge (see relevant section above).
The hydrophobic Millex FG filter (hydrophobic membrane) is connected to the tube leading to the final vial
instead of the Cathivex GS filter (hydrophilic membrane), so the line is blocked. In such a case, one of the
silicone tubes may pop out of its barb fittings, leading to leaks onto the synthesizer.
One silicone tube is squeezed between the front panel and the cassette holder (transparent cassette retainer) :
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Direction 2335256-100
the tube connecting the tC18 cartridge onto the cassette or the tube leading from the Alumina-N cartridge into
the [18F]-FDG vial. In such a case one of the silicone tubes may pop out of its barb fittings, leading to leaks
onto the synthesizer.
The tC18 cartridge or the Alumina N cartridge used for the final purification is defective and blocked (this
happens very rarely). Analyze the cartridges after synthesis : pass some water through the cartridges and check
if the flow-rate through the cartridges is abnormally low, i.e. if the backpressure is abnormally high.
The buffer is not transferred into the right hand syringe because of a piece of rubber from the stopper blocking
the spike. In such a case the vial is still filled with liquid at the end of the process and the pH of the [18F]-FDG
solution is too high.
The buffer leaks out of its vial, for example if the vial was not crimped properly. With stoppers other than the
one recommended in the user manual, leakages of liquid may happen through the piercing hole. In the case of
buffer leakages the pH of the [18F]-FDG solution will be too high.
There is an extension line mounted at the outlet of the cassette. The inner diameter of this extension line is too
low leading to high backpressure and leaks of FDG solution on the connections
There is an extension line mounted at the outlet of the cassette. The inner volume of the extension line is too
high. Thus some FDG solution is not transferred out of this extension line, into the final vial. Some FDG
solution is remaining in the tube.
There is an extension line mounted at the outlet of the cassette and the Cathivex filter is not mounted at the
end of this extension line (just before the final vial), but in between the cassette outlet and the extension
line. The gas used to push the FDG solution through the line is removed on this filter, thus there is no more
gas downstream of the Cathivex filter to push the solution though the extension line. Some FDG solution is
remaining in the tube.
There is an extension line mounted at the outlet of the cassette and some FDG solution leaks away on the
connections of this extension line onto the cassette outlet and/or onto the Cathivex filter.
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10. The quality of the final product does not meet the pharmaceutical requirements
In the case of a pH that is too high, the [18F]-FDG solution may also be slightly yellowish.
The amount or composition of the buffer mixture (citrate buffer + HCl) is not right.
There is too much sodium hydroxide in the 3 ml syringe (> 1ml) or the concentration of the sodium hydroxide
solution is too high.
The amount of sodium hydroxide injected into the cartridge is higher than 800 l. Adjust the position of the
syringe driver as described in the Yearly maintenance section of this manual.
The buffer was not transferred properly into the right hand syringe, so there is still some liquid left in the buffer
vial at the end of the synthesis. This may happen when the buffer spike is obstructed by a piece of rubber from
the stopper.
There are leaks of buffer through the piercing hole in the stopper after the pressurizing of the vial (during the
preliminary steps of the synthesis). This may happen with some stoppers which are not the same as the one
recommended in the documentation. Try to use another kind of stopper.
A low pH is often related to a uncomplete hydrolysis due to missing sodium hydroxide. In this case, the [18F]FDG may contain some unhydrolyzed or partially hydrolyzed labeled precursor ([18F]- TAFg) and the synthesis
yield may be affected. Refer also to section 6.6.
The amount or composition of the buffer mixture (citrate buffer + HCl) was not right.
There is not enough sodium hydroxide in the 3 ml syringe (< 1 ml) or the concentration of the sodium hydroxide
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The [18F]-FDG solution is cloudy; there are white particles in suspension. This may happen if no Cathivex filter
was used or if the Cathivex filter is defective. Such a cloudy [18F]-FDG solution can be recovered by a second
filtration through a 0.22 m filter and quality control on the filtered solution.
The [18F]-FDG solution is slightly yellowish. This may result from an improper purification through the tC18
cartridge in the case where the solution was not properly neutralized (too high pH). Such a yellowish [18F]-FDG
solution can be recovered by an adjustment of the pH, an additional purification through a tC18 cartridge and
a 0.22 m filter followed by quality control of the neutralized, purified, and filtered solution.
The common impurities in the [18F]-FDG solution, as produced by the TRACERlab MX FDG are the following :
free 18F- ions (less than 2%), the labeled precursor i.e. [18F]-TAFg (less than 0.5 %) and partially hydrolyzed [18F]TAFg (less than 0.5 %). No [18F]-FDM is produced by epimerization of [18F]-FDG under alkaline conditions at
room temperature.
If abnormal high amounts of unhydrolyzed or partially hydrolyzed labeled precursor ([18F]- TAFg) is detected in
the [18F]- FDG, this may indicate that the hydrolysis did not occur quantitatively because of some missing sodium
hydroxide. Refer also to section 10.2.
If other unknown radioactive compounds are detected in the [18F]-FDG solution, this may result from the analytical
method used for the quality control (QC) : radioactive contamination of the QC equipment, contamination of the
[18F]-FDG samples to be analyzed, insufficient shielding of the radioactivity detector, etc.
In the case where the radiochemical purity is measured by Thin Layer Chromatography (TLC), the TLC strips
should not be dried at an elevated temperature after spotting the sample just before migration. If the temperature
is too high, the [18F]-FDG may degrade, leading to the detection of the thermal degradation products.
F- ions which did not label the precursor are drained to the external waste bottle during the prepurification steps
before hydrolysis. The last traces of 18F- ions are retained on the Alumina N cartridge, therefore the amount of
residual 18F- ions in the final solution is generally below 2%.
18
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Direction 2335256-100
It is well knownthat with increasing specific radioactivity concentrations of [18F]-FDG, there are increasing
effects from autoradiolysis/ free radical formation on the stability of [18F]-FDG, which may result in rising levels
of free 18F- ions over time in the [18F]-FDG solution. For the [18F]-FDG solution containing citrate buffer, as
produced with the TRACERlab MX FDG, this radiolytic effect is limited to activity levels up to 3 Ci (in 17 ml
of [18F]-FDG solution). Above 3 Ci it is recommended that the [18F]-FDG solution is dilutedimmediately after
synthesis, to reduce the radiolytic effect, i.e. it is recommended that the [18F]-FDG is sent directly into a sterile
vial containing a sufficient amount of sterile physiological solution.
In the case the amount of partially hydrolyzed precursor ( [18F]-TAFg not fully converted into [18F]-FDG) is
abnormally high in the FDG solution, refer to the section relating to incomplete hydrolysis reaction and activity
not fully eluted out of the tC18 cartridge after hydrolysis.
10.7 The pH is too high, the amount of residual ethanol is too high and the
osmolality is too high
There was an inversion between the ethanol vial (yellow/golden color code) and the buffer vial (green color
code) while mounting the cassette onto the synthesizer.
There was a confusion with the color of the caps while preparing the reagents and filling the ethanol vial
(yellow/golden color code) and the buffer vial (green color code)
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86
Direction 2335256-100
87
88
Direction 2335256-100
89
Direction 2335256-100
Check the yields accurately by a low activity run. It has been shown that the yield is not affected by the activity
level involved in the process (tested up to 10 Ci). Therefore the real performances of the TRACERlab MX FDG
system can be determined accurately by a low activity run. Proceed as follows while taking care to observe all
applicable radiation safety regulations during these operations :
- Perform an irradiation and produce > 500 mCi of 18F. Transfer the irradiated 18O-water into a sufficiently
shielded vial.
- Withdraw a small amount of the irradiated 18O-water corresponding to 2-5 mCi of 18F and dilute it with 2 ml of
deionized natural 16O-water1. Suck the diluted 18F solution up into a syringe and measure the activity accurately
in a dose calibrator (activity measurement + time of measurement).
- Start a FDG synthesis
- Select Disable rinsing in the right lower corner of the user interface screen.
- When the Waiting for Activity Transfer window appears on the screen inject the diluted 18F solution through
the 18F inlet valve into the TRACERlab MX FDG and proceed with the synthesis.
- Measure the residual activity left on the syringe accurately using a dose calibrator (activity measurement +
time of measurement)
- At the end of the process measure the activity in the FDG vial accurately using a dose calibrator (activity
measurement + time of measurement)
To determine the yields all the activity measurements have to be corrected for decay taking into account 2
reference times : T1 being the time at start of synthesis (when the synthesis is started after transfer of 18F to
the TRACERlab MX FDG) and T2 being the time at the end of the synthesis (when the message FDG ready
appears on the screen). There are about 28 minutes elapsed between T1 and T2.
The EOS Yield (End Of Synthesis Yield , i.e. not decay corrected) is calculated by following ratio : (activity
in the FDG vial at T2) / (activity in the syringe before injection at T1 residual activity in the syringe after
injection at T1).
The % SOS Yield (Start Of Synthesis Yield, i.e. decay corrected) is calculated by following ratio : (activity
in the FDG vial at T1) / (activity in the syringe before injection at T1 residual activity in the syringe after
injection at T1)
If the yield obtained at low activity is lower than the specification, refer to Chapter 11 : troubleshooting of
the TRACERlab MX FDG : Service manual to analyze the origin of the low yield. Since the rinsing of the
cassette was disabled, it is possible to measure the residual activity on the cassette components which may be
useful for the troubleshooting.
Low activity runs can be used to check one by one the effect of different parameters such as the quality of the
reagents, the quality of the irradiated 18O-water, the quality of the gas,
Note :
at such low activities, the measurements done by the built-in activity detectors are meaningless. Only the
activity measurements done with the dose calibrator before and after the synthesis are relevant for the yield
calculation.
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Direction 2335256-100
Check the influence of the irradiated 18O-water quality. In some rare cases the yield is affected by impurities
in the irradiated 18O-water (impurities in the 18O-water used for bombardment, target impurities or other
contaminations during the transfer to the TRACERlab MX FDG system). The low activity run described in the
section here above does not allow to highlight the effect of such impurities since the irradiated 18O-water is
strongly diluted. To analyze the effect of impurities in the irradiated 18O-water proceed as follows, while taking
care to observe all applicable radiation safety regulations during these operations :
- Perform an irradiation under same conditions than usually for the routine productions. Transfer the irradiated
18
O-water into a sufficiently shielded vial and leave it for decay until there is only 2-5 mCi left.
- After sufficient decay, check the color of the irradiated water. Colored irradiated water or particles accumulated
at the bottom of the vial indicate that there are impurities in the irradiated 18O-water.
- Homogenize the solution, suck it up into a syringe together with all particles and measure the activity accurately
in a dose calibrator (activity measurement + time of measurement)
- Perform a low activity run as explained in the section here above
If the yield obtained during this low activity run with the irradiated 18O-water gave poor yields although the yield
obtained during the low activity run with the diluted irradiated 18O-water gave good yields, the low performances
are due to impurities in the irradiated 18O-water.
(Footnotes)
1 For example : if the irradiated 18O-water coming from the cyclotron contains 1000 mCi of 18F in 2 ml of 18O
water, withdraw 10 l to get 5 mCi.
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Direction 2335256-100
Important note :
This Remote Control Box does not allow to perform the self-test of the synthesizer and the cassette test. There
will be no feedback from the synthesis and no production report will be generated.
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Direction 2335256-100
Appendix
The Maintenance and Replacement Procedures of the appendix are summarized in the table below.
For older versions of the TRACERlab MX FDG, some procedures may not be fully applicable as they are. Do not
hesitate to contact the supplier or manufacturer of the equipment for assistance.
Type of procedure
Removal of the cover
Replacement of the activity inlet pinch valve tube
Replacement of the elution system pinch valve tube
Replacement of the elution system tube inserts (on the conical block)
Replacement of the elution system
Replacement of the electronic vacuum gauge
Replacement of the vacuum pump
Replacement of the 30 ml syringe actuator mechanism
Replacement of the 3 ml syringe actuator mechanism
Adjustment of the activity detector position in the case of saturation
Adjustment of the pressure levels : High Pressure (HP) & Low Pressure (LP)
Replacement of the nitrogen filter cartridge
Replacement of the compressed air filter cartridge
Replacement of an internal valve
Replacement of the 18F inlet pinch valve
Replacement of the PLC power supply
Replacement of the 24 Vdc power supply
Replacement of the CPU battery
Replacement of the mains fuse
Replacement of the heater fuse
Replacement of the PLC fuse
Procedure number
MR-001-001
MR-001-002
MR-001-003
MR-001-004
MR-001-005
MR-001-006
MR-001-008
MR-001-009
MR-001-010
MR-001-011
MR-001-012
MR-001-013
MR-001-014
MR-001-015
MR-001-016
MR-001-017
MR-001-018
MR-001-020
MR-001-021
MR-001-022
MR-001-023
A general wiring diagram, a general tubing diagram and a general pneumatic diagram can be found at the end of
this appendix.
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Direction 2335256-100
MR-001-001
MATERIAL
No material is needed for this operation
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply, before removing the cover.
There are 8 screws fixing the cover onto the TRACERlab MX FDG.
With a flat-headed screwdriver, unscrew and remove both screws that are on the back of the cover at the rear of
the TRACERlab MX FDG.
Unscrew (but dont remove) those on the left side, on the right side, and on the top.
Slide the cover off, carefully.
While putting the cover back in place, take care not to squeeze any tubing
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Direction 2335256-100
MR-001-002
MATERIAL
Detailed description
Silicone tubing, ID (Inner Diameter) = 1 mm
OD (Outer Diameter) = 3 mm, length = 55 mm
Ordering information :
description, part number
Set of accessories for elution
and activity inlet system, 2357682
PROCEDURE
Disconnect the worn tube and remove it from the pinch valve.
Cut a piece of silicone tubing : ID = 1 mm, OD = 3 mm, length = 55 mm.
Take the white Teflon tube connected to the front part of the elution system and slide it at least 10 mm deep into
the silicone tube.
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Direction 2335256-100
MR-001-003
MATERIAL
Detailed description
Silicone tubing, ID (Inner Diameter) = 0.58 mm
OD (Outer Diameter) = 2.4 mm, length 100 mm
Ordering information :
description, part number
Set of accessories for elution
and activity inlet system, 2357682
PROCEDURE
Disconnect the worn tube and remove it from the pinch valve.
Cut a piece of silicone tubing : ID = 0.58 mm, OD = 2.4 mm, length = 100 mm.
Slide one end of the tube onto the upper cannula and the other end onto the lower cannula of the elution system.
Take care not to damage the tube.
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Direction 2335256-100
MR-001-004
MATERIAL
Detailed description
PEEK tubing, ID (Inner Diameter) = 0.8 mm and
OD (Outer Diameter) = 1.6 mm
PROCEDURE
Ordering information :
description, part number
Set of accessories for elution
and activity inlet system, 2357682
Replace the tubes as soon as you notice that they are damaged or bent.
Using a pair of pliers, pull the two worn or damaged PEEK inserts out of the conical part of the elution system.
Cut two pieces of PEEK tubing so that there is a bevel on one end (approx. 45 ) : ID = 0.8 mm, OD = 1.6 mm, length = 40 mm.
Take care not to squeeze the tubing while cutting the tube pieces.
Using a pair of pliers, insert each piece of tube with the beveled edge into one hole of the conical part of the elution system. The
tubes should be inserted at least 1 mm deep into the holes. Take care not to squeeze or bend the tubes during this operation.
To avoid splashes on the reservoir and losses of 18F starting activity while transferring the irradiated water to the TRACERlab
MX FDG, cut the tubes with a bevel (approx. 45 ) so that the end of the tube is located about 3 mm above the liquid level
corresponding to the target volume (i.e. the amount of irradiated 18O water sent to the TRACERlab MX FDG). For a 2 ml target,
the length of the tubing plunging into the reservoir should be about 17 mm.
Important note :
If the amounts of irradiated 18O water is not always the same, e.g. if FDG syntheses are carried out with a
single beam irradiation alternating with dual beam irradiations, the PEEK tube should be cut in such a way
that the tubes never plunge into the liquid, i.e. they should be cut taking into account the maximum amount
of liquid in the reservoir.
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MR-001-005
MATERIAL
Detailed description
Elution system with pinch valve and tubing
Ordering information :
description, part number
Elution system (front piece only), 2333382
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
Remove the elution system to be replaced, as described below.
The pinch valve of the elution system is connected onto the green terminal block (behind the front panel, on the
left hand side facing the TRACERlab MX FDG). Unscrew and disconnect the two wires connecting the elution
pinch valve to the terminal block . Take care to leave the other wires in place.
Remove the white Teflon tube from the silicone tube located in the activity inlet pinch valve .
Disconnect the tube used to pressurize and depressurize the reservoir : unscrew the male luer lock connector
from the front panel (connector located on the left hand side of the elution system, below the activity inlet pinch
valve).
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Direction 2335256-100
MR-001-005A
Teflon tubing
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102
MR-001-005A
Direction 2335256-100
MR-001-005A
Using a flat-headed screwdriver fix the new elution system onto the front panel using the second thread hole
(lower position).
Connect the two wires to the green terminal block. Note that there is no polarity on the wires of the pinch valve.
Take the white Teflon tube connected to the front part of the elution system and slide it at least 10 mm deep into the
silicone tube of the activity inlet pinch valve.
Connect the male luer onto the front panel (onto the female luer connector located on the left hand side of the elution
system, below the activity inlet pinch valve).
Put the cover back in place on the TRACERlab MX FDG. Take care that no tubing is squeezed while sliding the cover
onto the TRACERlab MX FDG.
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MR-001-006
MATERIAL
Detailed description
Electronic vacuum gauge used for the regulation of
vacuum. Gives the vacuum value as displayed on the
user interface screen
Ordering information :
description, part number
Electronic vacuum gauge, 2333424
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of TRACERlab MX FDG (refer to procedure MR-001-001A).
Remove the worn electronic vacuum gauge, as described below.
Disconnect the quick connector on the top
(electrical connection) and unscrew the two
bolts.
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Direction 2335256-100
MR-001-006
Fix the new electronic vacuum gauge, connect the quick connector and the silicone tube.
Put the cover back in place on the TRACERlab MX FDG. Take care that no tubing is squeezed while sliding the
cover onto the TRACERlab MX FDG.
Refer to the TRACERlab MX FDG : Service Manual chapter Yearly Maintenance for the adjustment
of the vacuum measurement through the potentiometer (screw on the front panel, just below the mechanical
vacuometer).
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MR-001-008
MATERIAL
Detailed description
Double-head membrane vacuum pump
Ordering information :
description, part number
Vacuum pump, 2333426
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
Take out the worn pump, as described below.
Exhaust tubing
Identify the two silicone tubes connected to the pump : From waste tube and Exhaust tube.
Disconnect the silicon tubes fixed to the pump.
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Direction 2335256-100
MR-001-008
Quick connector
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Direction 2335256-100
MR-001-008
Connect the new pump using the quick-connector. For some older versions of the TRACERlab MX FDG, the new
pump has to be connected by soldering the wires in conformity with the polarity (respect the color code red/black
and insulate each wire individually after soldering, using insulating tape).
Put the pump back into the rubber retainer and connect the silicone tubes to the pump. Take care not to confuse
the From waste tube and the Exhaust tube.
Put the cover back in place on the TRACERlab MX FDG. Take care that no tubing is squeezed while sliding the
cover onto the TRACERlab MX FDG.
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MR-001-009
MATERIAL
Detailed description
Syringe driver consisting of a control card, DC
motor, and pulley transmission to the guided linear
unit
Ordering information :
description, part number
Syringe actuator mechanism
(without front piece), 2333632
If the front piece also has to be replaced, the following item is required :
Detailed description
Font piece for 30 ml syringe driver, with spring
allowing hooking onto the syringe piston
Ordering information :
description, part number
Syringe push-pull hook front piece
(30 ml syringe), 2333633
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
Using the Allen key, unscrew the two screws located in the holes of the white cylindrical front piece.
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Direction 2335256-100
MR-001-009
110
Direction 2335256-100
MR-001-009
111
Direction 2335256-100
MR-001-009
112
Direction 2335256-100
MR-001-010
MATERIAL
Detailed description
Syringe driver consisting of a control card, DC
motor, and pulley transmission to the guided linear
unit
Ordering information :
description, part number
Syringe actuator mechanism
(without front piece), 2333632
If the front piece also has to be replaced, the following item is required :
Detailed description
Font piece for 3 ml syringe driver, allowing only
pushing of the syringe piston
Ordering information :
description, part number
Syringe push front piece
(3 ml syringe), 2333634
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
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Direction 2335256-100
MR-001-010
114
Direction 2335256-100
MR-001-010
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Direction 2335256-100
MR-001-010
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Direction 2335256-100
MR-001-010
In maintenance mode, activate the valve below the 3 ml syringe (valves #10) and the valve below the purification
tC18 cartridge (valve #12).
Move the 3ml syringe driver to a position just above the syringe piston : enter 25 mm as the value in the position
setpoint field. Verify that the front piece is properly positioned above the piston.
Move the 3ml syringe driver to the same position as used in the FDG synthesis process during the hydrolysis step:
enter 7 mm as the value in the position setpoint field.
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Direction 2335256-100
MR-001-010
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Direction 2335256-100
MR-001-011
TOOLS
1 flat-headed screwdriver (6 mm)
MATERIAL
No material is needed for this operation
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A)
There are four built-in activity detectors in the TRACERlab MX FDG :
3
4
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Direction 2335256-100
MR-001-011
Put the cover back in place on the TRACERlab MX FDG. Take care that no tubing is squeezed while sliding the
cover onto the TRACERlab MX FDG.
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Direction 2335256-100
MR-001-012
MATERIAL
No material is needed for this operation
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
Connect the TRACERlab MX FDG to the power supply. Take care not to touch the electrical connections inside
the TRACERlab MX FDG.
Run the user interface software and set it to the maintenance mode.
Open the nitrogen supply to the TRACERlab MX FDG.
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Direction 2335256-100
MR-001-012
Purge the nitrogen circuit by opening the HP valve (or LP valve) for 15
seconds.
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Direction 2335256-100
MR-001-012
Adjust the HP level to 0.7 bar (0.4 bar for the LP level) referring to the external calibrated manometer, by turning
the regulator slowly clockwise.
The High Pressure (HP) level should be between 0.6 and 0.8 bar. The low Pressure (LP) level should be between
0.35 and 0.5 bar
After adjusting the pressure levels, reset all the outputs using the reset button in the maintenance mode, and
connect the elution system to the female luer connector located on the front panel, below the activity inlet pinch
valve.
Set the TRACERlab MX FDG to the standby mode and quit the software. Disconnect the TRACERlab MX FDG
from the power supply.
Put the cover back in place on the TRACERlab MX FDG. Take care that no tubing is squeezed while sliding the
cover onto the TRACERlab MX FDG.
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MR-001-013
MATERIAL
Detailed description
Cartridge for particles filtering (7 m)
from the nitrogen.
Ordering information :
description, part number
Replacement cartridges
(for nitrogen filter
and compressed air filter) 2333596
PROCEDURE
There are two different models of nitrogen filters. The first
one is made of brass and the second looks like the compressed
air filter 4,5 bars. The second filter has been installed on the
TRACERlab MX FDG Serial Number 213, 215, 218, 219 and
> 222. The cartridge filter 7m SWAGELOK is used for the
filter made of brass (the old one) and the cartridge filter 5m
SMC is used for the second filter (the new one).
Old model (made of brass) on the left and new model on the
right
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Direction 2335256-100
MR-001-013
Pull out the tube from the one-touch fitting on the valve located
at the rear of the nitrogen filter. Push the connector towards
the valve while pulling the tube out. Do not remove the tube
directly from the connectors on the filter.
Unscrew the cap anticlockwise and take off the cap of the
filter.
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Direction 2335256-100
MR-001-013
Replacement of the nitrogen cartridge for the new model
filter
The nitrogen filter is located inside the TRACERlab MX FDG,
on the left side.
Using the flat-headed screwdriver, unscrew the screw fixing
the filter to the side panel.
Pull out the tube from the one-touch fitting on the valve located
at the rear of the nitrogen filter. Push the connector towards
the valve while pulling the tube out. Do not remove the tube
directly from the connectors on the filter.
Pull out the tube from the one-touch fitting on the valve located
at the front of the nitrogen filter. Push the connector towards
the valve while pulling the tube out. Do not remove the tube
directly from the connectors on the filter
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Direction 2335256-100
MR-001-013
Take the filtering cartridge out and replace it with a new one
(Component 00239).
Reassemble and screw the tank back onto the pressure filter.
Connect the filter to the tube on one side and to the valve on
the other side.
Fix the filter to the side panel.
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128
Direction 2335256-100
MR-001-014
MATERIAL
Detailed description
24 Vdc solenoid valve with tubing connector and
electrical quick connector
Ordering information :
description, part number
Valve for internal tubing, 2333432
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
Carefully disconnect the tubes above and below
the concerned valve.
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Direction 2335256-100
MR-001-014
Screw the new valve onto the frame of the TRACERlab MX FDG.
Connect the new valve using the quick connector. On older versions of the TRACERlab MX FDG without a quick
connector, the new valve has to be connected by soldering the wires and insulating each wire individually using
insulating tape.
Connect the tubes above and below the valve.
Put the cover back in place on the TRACERlab MX FDG. Take care that no tubing is squeezed while sliding the
cover onto the TRACERlab MX FDG.
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Direction 2335256-100
MR-001-015
MATERIAL
Detailed description
24 Vdc pinch valve for 3 mm OD and 1 mm ID
silicone tubing
Ordering information :
description, part number
Pinch valve for activity inlet, 2333425
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
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Direction 2335256-100
MR-001-015
Unscrew and take off the green plug on the internal part of the elution system mechanism.
Disconnect the tube supplying compressed air to the elution mechanism by unscrewing the luer lock
connection.
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Direction 2335256-100
MR-001-015
Replace the valve and connect the new pinch valve by soldering the wires and insulating them each individually
using insulating tape. The wires do not have any polarity.
Fix the pinch valve to the front panel.
Put the elution system mechanism back in place, screw on the electrical connector and connect the tube supplying
compressed air to the mechanism.
Fix the elution system (front piece) to the front panel.
Fix the aluminum bar on the upper rear side of the front panel, and fix the upper screw of the water bag hook.
Put the cover back in place on the TRACERlab MX FDG. Take care that no tubing is squeezed while sliding the
cover onto the TRACERlab MX FDG.
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Direction 2335256-100
MR-001-016
MATERIAL
Detailed description
Power supply unit powering the Programmable
Logical Controller (PLC) at 24 Vdc
Ordering information :
description, part number
PLC card : 2A Power Supply 120/240
Vac, 2333770
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
Remove the PLC power supply to be replaced, as described below.
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MR-001-016
Unscrew the two cross-headed screws located in the upper and lower
right corner of the PLC power supply.
Slide the PLC power supply card out of the PLC frame.
Put the new PLC power supply in place, and fix it with the two
cross headed screws.
Connect the three wires as follows :
135
Direction 2335256-100
MR-001-016
Check that the PLC power supply card is set to the right
mains power supply (either 120 V or 240 V). Connect the
white plug to conform with the power supply :
136
Direction 2335256-100
MR-001-017
MATERIAL
Detailed description
Power supply (24 Vdc-6,3A-150W) for all the
components of the TRACERlab MX FDG powered
at 24 Vdc except the Programmable Logical
Controller
Ordering information :
description, part number
24 Vdc Power supply, 2333599
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
Remove the 24 Vdc power supply to be replaced, as described below. The 24 Vdc power supply unit is located at
the rear of the TRACERlab MX FDG on the left hand side of the Programmable Logical Controller.
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Direction 2335256-100
MR-001-017
138
Direction 2335256-100
MR-001-017
Connect the electrical connector to the bottom of the new power supply unit.
Fix the new power supply unit to the side panel.
Connect the two electrical connectors to the top of the new power supply unit.
Tie the wires using a clamp collar.
Put the cover back in place on the TRACERlab MX FDG. Take care that no tubing is squeezed while sliding the
cover onto the TRACERlab MX FDG.
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Direction 2335256-100
MR-001-018
MATERIAL
Detailed description
Lithium battery in the SLC 5/04 CPU processor,
providing back-up power for the RAM when the
TRACERlab MX FDG is disconnected from power
supply
Ordering information :
description, part number
CPU battery, 2333598
PROCEDURE
To avoid loosing the data in RAM, replace the battery within 30 minutes after disconnection of the battery
from the SLC 5/04 CPU processor card. There is a capacitor that provides at least 30 minutes of battery backup while the battery is disconnected.
The user is informed that the battery is low through an error indicator in the bottom right-hand corner of the
About window (user interface screen). If the battery is low, replace the battery as soon as possible, and keep
the TRACERlab MX FDG switched on until the battery has been replaced.
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
Take out the SLC 5/04 CPU processor card (on the right hand side of the PLC power supply) and replace the
battery, as described below.
Open the door located on the right-hand side of the Power-Supply.
Disconnect the RS232 serial cable from the SLC 5/04 CPU processor
card.
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Direction 2335256-100
MR-001-018
Remove the SLC 5/04 CPU processor card from the chassis by pressing
both retainer clips simultaneously (one on the top and one on the bottom
of the card). Slide the card out of the chassis. If the TRACERlab MX FDG
is still powered at this stage, this may lead to damage on the PLC.
Do not expose the processor to surfaces or other areas that may typically
hold an electrostatic charge. Electrostatic charges can alter or destroy
memory
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Direction 2335256-100
MR-001-018
Re-insert the SLC 5/04 CPU processor card into the PLC chassis.
Connect the R232 cable to the SLC 5/04 CPU processor card.
Close the door of the SLC 5/04 CPU processor card.
Put the cover back in place on the TRACERlab MX FDG. Take care that no tubing is squeezed while sliding the
cover onto the TRACERlab MX FDG.
Note :
The SLC 5/04 CPU processor provides back-up power for the RAM through a replaceable lithium battery. This
battery provides back-up power for approximately 2 years to ensure that the PLC program remains stored in the
RAM when the TRACERlab MX FDG is disconnected from the power supply. The BATT LED on the front of the
processor gives a warning when the battery voltage has fallen below a threshold level.
142
Direction 2335256-100
MR-001-019
MATERIAL
Detailed description
Fuse (2 A) for mains on IEC plug for an TRACERlab
MX FDG operated at 220 V
Ordering information :
description, part number
Set of fuses, mains 220V (for PLC 3 A, for heater
1 A and for mains on IEC plug 2 A), by lot of 5,
2357707
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
143
Direction 2335256-100
MR-001-020
MATERIAL
Detailed description
Heater fuse (1 A) for an TRACERlab MX
operated at 220 V
Ordering information :
description, part number
Set of fuses, mains 220V (for PLC 3 A, for heater
1 A and for mains on IEC plug 2 A), by lot of
5, 2357707
Set of fuses, mains 110V (for PLC 3 A, for heater
2 A and for mains on IEC plug 3.15 A), by lot of
5, 2357705
FDG
FDG
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
144
Direction 2335256-100
MR-001-021
MATERIAL
Detailed description
Fuse in the Programmable Logical Controller (PLC)
power supply (3 A), for an TRACERlab MX FDG
operated at 220 V
Ordering information :
description, part number
Set of fuses, mains 220V (for PLC 3 A, for heater
1 A and for mains on IEC plug 2 A), by lot of 5,
2357707
PROCEDURE
Disconnect the TRACERlab MX FDG from the power supply.
Remove the cover of the TRACERlab MX FDG (refer to procedure MR-001-001A).
Open the door of the Programmable Logical Controller (PLC) power supply, located on the left-hand side of the
CPU card.
Take the fuse out and replace it.
145
TRACERlab MX FDG
GENERAL ELECTRIC
MEDICAL SYSTEMS
BENELUX S.A.