Manual de Servicio Sintesizador

Technical
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
Version III - Last Update : June 2008
TRACERlab MX FDG - SERVICE MANUAL
This page was left intentionally blank.
WARRANTY AND LIABILITY

The Manufacturer or supplier of this equipment will not accept liability for injury to personnel or damage to
equipment that may result from misuse of this equipment, failure to observe the hazard notice contained in this
manual, or failure to observe local regulations. In addition, he will not accept any liability for the consequences of
the administration in humans of any compound produced by this equipment. The decision to authorize use of any
lot of any of these compounds for humans is the sole responsibility of the user or of his designated pharmacist.
Whilst every effort has been made to ensure the technical accuracy of this manual, the information contained
herein is subject to change without notice. The manufacturer or supplier makes no warranty of any kind with
regard to this material.
The manufacturer or supplier shall not be liable for errors contained herein, or for incidental or consequential
damages arising from the equipment described in this manual.
DISTRIBUTOR :
GEMS Benelux s.a.
78, rue Marie Curie, B-4431 Lige (Loncin)

BELGIUM
Tel. : +32 (0)4 247 84 21 Fax : +32 (0)4 247 84 20
www.gehealthcare.be
TABLE OF CONTENTS
CHAPTER 1 : INTRODUCTION
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CHAPTER 2 :
HEALTH AND SAFETY INFORMATION
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2.1 Radiation safety
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2.2 Caution relating to caustic substances
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2.3 Caution relating to toxic substances
20
2.4 Caution relating to inflammable substances
20
2.5 Caution relating to liquid spillage
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2.6 Electrical safety
21
2.7 Temperature hazard
21
2.8 Mechanical motion safety
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2.9 Caution relating to heavy objects
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2.10 Accident involving personal injury
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2.11 Accident involving fire
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2.12 Safety labels
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2.13 Hazardous areas inside the TRACERlab MX FDG
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CHAPTER 3 :
SERVICE JOB SAFETY ANALYSIS
26
CHAPTER 4 :
CE MARKING
29
CHAPTER 5 : DESCRIPTION OF THE EQUIPMENT
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1.
General description
31
2.
Dimensions of the TRACERlab MX FDG
32
3.
Weight of the TRACERlab MX FDG
32
4.
Connections
32
4.1 Connections at the rear
32
4.2 Connections on the front
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5.
Front view of the TRACERlab MX FDG
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6.
Rear view, central part of the TRACERlab MX FDG
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7.
Left side (as seen from the front)
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7.1 Nitrogen supply circuit
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7.2 Compressed air supply circuit
39
8.
Right side view of the TRACERlab MX FDG
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9.
Top view of the TRACERlab MX FDG
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CHAPTER 6 : MAINTENANCE MODE
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1.
Setting of the TRACERlab MX FDG to the maintenance mode
43
2.
Activation of the rotating valve actuators
45
3.
Activation of internal valves
45
4.
Operation of the syringe drivers
45

5. Operation of the heater

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
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.
15
16
Chapter 2 : Health and Safety Information

Important :
All personnel associated with the operation of the TRACERlab MX FDG must be appropriately qualified, made
familiar with its operation and informed of all applicable health and safety regulations.
All personnel must read this chapter and be fully aware of its contents before operating or servicing the
TRACERlab MX FDG.
It is the customers responsibility to ensure that all personnel involved in the operation and service of the
TRACERlab MX FDG observe the health and safety regulations at all times.
2.1. Radiation Safety
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
18
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.
17
In the event of a radiation accident, all personnel must observe the applicable local laws and regulations.
2.2 Caution relating to caustic substances
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.
2.3 Caution relating to toxic 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.
2.4 Caution relating to inflammable 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.
18
2.5 Caution relating to liquid spillage

Severe liquid spillage on the TRACERlab MX FDG may cause the main fuses to blow and may result in damage to
the TRACERlab MX FDG. Cut off the power supply and wipe off any liquid spillage immediately. If the liquid is
radioactive, wait until the radioactivity has decayed.
Liquid spillages may contain radioactive, caustic or toxic substances. Use protective gloves while wiping off
liquid spillages.
2.6 Electrical safety
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)
2.7 Temperature hazard
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.
2.8 Mechanical motion safety
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
2.9 Caution relating to heavy objects
The TRACERlab MX FDG weighs about 50 kg and can cause injury if not installed in a stable manner.
19
2.10 Accident involving personal injury
In the event of an accident involving personal injury, seek urgent medical attention.
2.11 Accident involving fire
In the case of fire, follow the local emergency procedures.
2.12 Safety labels
The following safety labels are used on the TRACERlab MX FDG

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.
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.
Right lower corner on the front panel and left lower corner on the rear panel.
Ensure that the TRACERlab MX FDG is powered at the right voltage

(240 Vac or 115Vac).
Rear panel, near the power supply plug.
AC
2.13 Hazardous areas inside the TRACERlab MX FDG
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
20
- 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
designed for 115Vac power
Do not touch these components when the TRACERlab MX FDG is powered up.
21
Hazardous areas powered at 220Vac or 115Vac
Solid state relay
24 V DC power supply
PLC power supply
Main terminal block
Toroidal Transformer
(only for equipment powered at 120V)
Power Supply plug
22
Hazardous areas powered at 220Vac or 115Vac (continuation)
Heater
23
Verify system installation.
Verify cleanness and check for any chemical spillage.
Verify if last production was completed.
Radiation
Decide if radiation level low enough to start work,

control removal of previous cassette and emptying of
waste Jar.
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.
Exposure to Acetonitrile, Sodium Hydroxide,

Hydrocloric acid and other chemicals.
The FDG-Tracer Lab weighs 48 Kg.
Chemical
Mechanical
/...
IF THE CHEMICAL IS RADIOACTIVE, WAIT UNTIL THE RADIOACTIVITY HAS

DECAYED TO A LEVEL COMPATIBLE WITH THE JOB TIME AND YOUR PERSONAL
ACCUMULATED DOSE.
Ionization effect and surface contamination.
Radiation

DECAYED TO A LEVEL COMPATIBLE WITH THE JOB TIME AND YOUR PERSONAL
ACCUMULATED DOSE.
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
BE SURE THAT ALL PRODUCTION WAS DELIVERED AND THAT RESIDUAL

REAGENTS HAVE BEEN FLUSHED TO THE WASTE JAR.
PPE

Hydrocloric acid and other chemicals.

Activity from previous production collected in
the waste jar and O18 water recovery jar.

Ionization effect.
CAUSES
Chemical
Radiation
None
Radiation
Risk HAZARD
Level
Verify last production date and time. Use it to calculate

estimated radiation level in the Process Module.
Measure radiation level in the room.
TASK
JOB TITLE : Examine the casing of the Process Module
OK to proceed with task

Proceed with caution
Do not proceed until all safety precautions have been completed
RISK LEVEL
SAFETY - REMEMBER : TIME; DISTANCE; SHIELDING

NEVER WORK ALONE IN THE RADIATION AREA
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
IMPORTANT SAFETY PROCEDURES TO BE OBSERVED PRIOR TO COMMENCING WORK :
CHAPTER 3 : TRACERLAB MX
SERVICE JOB SAFETY ANALYSIS (1)
Replacement of the Elution block.
Replace tubes from the two pinch valves
JOB TITLE : Replace worn parts
Verify visually power supply and fuses
Visual inspection
Inspect cables and connectors
Disconnect system from electric power

and close all gas supplies
JOB TITLE : Diagnostic procedure
and level of filling.
Look at containers and lines for any damage, leakage
TASK
Accumulation of activity (solid deposit) inside

the silicon tube of the INLET pinch valve.
Accumulation of activity (solid deposit) inside

the fluid pathway
Radiation/
regulation

Hydrocloric acid and other chemicals
Contact with live or charged components
Contact with live or charged components

Hydrocloric acid and other chemicals
CAUSES
Radiation/
regulation
Chemical
Electrical
None
None
Electrical
Chemical
Radiation
Risk HAZARD
Level
JOB TITLE : Examine all waste liquid containers

PPE
CONTROL MEASURES
/...
DO NOT DISPOSE OF THIS PIECE INTO THE TRASH. IT IS LIKELY TO CONTAIN

TRACES OF LONGER HALF-LIFE ISOTOPES RELEASED BY THE TARGET SYSTEM.
VERIFY ACTIVITY LEVEL WITH APPROPRIATE SURFACE CONTAMINATION
MONITOR. IF NEEDED, PLACE IT FOR STORAGE IN A LEAD CONTAINER.
DO NOT DISPOSE OF THIS PIECE OF SILICON TUBE INTO THE TRASH.

IT IS LIKELY TO CONTAIN TRACES OF LONGER HALF-LIFE ISOTOPES RELEASED
BY THE TARGET SYSTEM. PLACE IT FOR STORAGE IN A LEAD CONTAINER FOR
A FEW MONTHS. CUSTOMER SAFETY OFFICER WILL DECIDE WHEN IT CAN BE
SAFELY DISPOSED OF. BE AWARE THAT TARGET TRANSFER LINE MAY STILL
CONTAIN ACTIVITY AND MAY BE PRESSURIZED.
CASE OF CONTACT WASH ABUNDA.
VERIFY THAT SYSTEM IS OFF AND LOTO APPLIED BEFORE REPLACING OR

TOUCHING FUSES OR OTHER ELECTRONIC COMPONENTS
APPLY LOTO PROCEDURE.

DECAYED TO LEVEL THAT CAN BE SAFELY HANDLED.


RISK LEVEL
TRACERLAB MX
Contact with charged components.
Electrical
PPE
None
None
None
None
None
None
Check all the internal valves
Check the gas flow rates
Check gas pressure levels
Check the heater
Check the syringe drivers
Check the rotating actuators
Insert new kit in place

Mechanical
Thermal
None
Check the pump
JOB TITLE : Install new FDG kit
None
Check the electronic vacuum gauge
Pinch risk from moving parts
Heating device in reaction vessel cavity
CONTROL MEASURES
VERIFY THAT SYSTEM IS OFF AND LOTO APPLIED BEFORE REPLACING OR

TOUCHING FUSES OR OTHER ELECTRONIC COMPONENTS
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.
DO NOT TOUCH THE HEATING DEVICE WHEN MOUNTING THE KIT.
UNLOCK ENERGY SOURCES AND

SET SYSTEM TO OPERATIONAL CONDITIONS
JOB TITLE : Check all module components. (It is assumed that the module contains no activity at that time).
Exposure to Sodium Hydroxide, Hydrocloric

acid or other chemicals.
Fluid remaining in the tube
CAUSES
Chemical
Chemical
Risk HAZARD
Level


Replace valves subjected to chemical corrosion.
Replace waste tubes and fittings exposed to radioactive

liquid and gases.
TASK
JOB TITLE : Replace worn parts
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RISK LEVEL
TRACERLAB MX
CHAPTER 4 - CE MARKING
The TRACERlab MX FDG is marked with the
harmonized standards :
symbol in conformance with the following directives and
Electromagnetic Compatibility (EMC) Directive 89/336/EEC

- CISPR 22
Information technology equipment - Radio disturbance characteristics - Limits and methods of
measurement

- Harmonized Standard EN61326 - 1 : 1997
Electrical equipment for measurement, control and laboratory use - EMC requirements
Low Voltage Directive 73/23/EEC

- Harmonized Standard EN61010-1 : 2001
Safety requirements for electrical equipment for measurement, control and laboratory use
A label with the required power supply voltage is also located near the power supply plug at the rear of the
TRACERlab MX FDG.
symbol is located on the right side of the TRACERlab MX FDG together with a label
The label with the
mentioning the model denomination, the serial number, the required power supply voltage and frequency.
The following label is placed on the right side

of an TRACERlab MX FDG to be powered at 220 Vac :
The following label is placed on the right side

of an TRACERlab MX FDG to be powered at 115 Vac :
27
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Chapter 5 : Description of the Equipment

1. General description
The most characteristic feature of the TRACERlab MX FDG is the use of a disposable synthesis cassette (also
called kit) : the chemicals come in contact only with commercially available disposable components assembled
as a hardware cassette based on the Luer connection system.
The hardware cassette is built around three multiple stopcock manifolds. It includes the labeling reaction
vial, the connections for incoming and outgoing fluids, spikes for the connection with the reagent containers,
as well as various Solid Phase Extraction (SPE) cartridges, syringes and filters. The reagents are packed in
standard containers with color coded crimp caps. The color coding permits easy identification of the reagents and
corresponds with the colors of the spikes where they are plugged on.
The front panel of the TRACERlab MX FDG closely matches the cassette and the reagent containers. It has an array
of pneumatic actuators allowing the rotation of the valves of the manifolds, and three linear actuators to drive
the syringes. The labeling reaction vessel is placed in a heater equipped with a thermocouple for temperature
regulation. A vacuum pump allows the draining of the waste fluids out of the system into a shielded external
waste bottle connected to the pump. The different vacuum levels needed during the synthesis (for the liquid
transfers, solvent evaporation, etc.) are regulated through an electronic vacuum gauge. Solenoid valves located
in the TRACERlab MX FDG ensure the connection between gas supply lines, vacuum lines and the cassette. Four
radiation detectors are built into the system, allowing the measurement of the radioactivity entering the system,
in the reaction vessel, on the hydrolysis cartridge and in the [18F]FDG final vial.
A Programmable Logical Controller (PLC), located inside the TRACERlab MX FDG, operates all subsystems such
as valves, actuators, heater, vacuum pump and sensors. The PLC is connected to a PC via a standard RS232 serial
line cable. There is no electronic or switching box between the PLC and the PC.
The role of the graphical user interface on the PC is to assist the operator throughout the FDG production
procedure, to allow visualization of the process, to view and record data and to prepare an after-synthesis report.
Once the synthesis has been started, the TRACERlab MX FDG becomes independent from the computer and
will perform the synthesis autonomously. If the PC is disconnected or fails during the process, the process will
continue normally until the end, as usual. The TRACERlab MX FDG can even be operated without a PC, using the
remote control box. However, in this case there is no possibility of logging data or of viewing any measurements
such as radioactivity, pressure or temperature.
The TRACERlab MX FDG can be operated in the Synthesis Mode or in the Maintenance Mode.
The Synthesis Mode is the mode used for routine FDG production. In this mode the operator is guided through
the whole FDG production. For more details about this mode refer to the TRACERlab MX FDG : Operator
Manual.
The Maintenance Mode allows to operate any component of the TRACERlab MX FDG : rotating valve actuators,
internal valves, syringe actuators, heater, vacuum pump and clamps holding the cassette in place. This operating
mode is used to check the proper functioning of these components.
29
2. Dimensions of the TRACERlab MX FDG

The dimensions of the TRACERlab MX FDG are as follows :

length :
564 mm (22.2")

depth :
362 mm (14.3")

height :
420 mm (16.5")
3. Weight of the TRACERlab MX FDG

The TRACERlab MX FDG weighs about 50 kg.
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.
4.1 Connections at the rear
The following connections are located at the rear of the TRACERlab MX

from the back) :
FDG
(listed from right to left, as seen
- 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;
30
4.2 Connections on the front
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
18
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;
5. Front view of the TRACERlab MX FDG

The white lead piece on the front panel of the TRACERlab MX FDG is designed to closely match the disposable
cassette. The front panel has 3 syringe drivers and an array of 15 rotating actuators adapted to the stopcock
manifolds of the cassette.
The elution system with the cap for the reservoir, located in the upper left corner of the front panel, can move up
and down. In the upper position, the reservoir and the anion exchange cartridge of the synthesis cassette can be
placed or removed. The cap connects to the reservoir when the elution system is in the down position. The elution
system can be moved by pressing the Clamp button located on the front panel of TRACERlab MX FDG. This will
also actuate the three clamps used to hold the cassette on the front panel (see below).
Three clamps, flush with the horizontal table in their released position, pop out of the table surface when actuated
and hold the cassette in place during the FDG production process. This is done by pressing the Clamp button
located on the front panel of the TRACERlab MX FDG.
There are two cavities in the horizontal table. The left cavity receives the reaction vessel and contains the heater,
whereas the right cavity receives the final FDG vial. Both cavities are equipped with a radiation detector.
3 light indicators located on the front panel of the module will inform the operator when the TRACERlab MX FDG is
powered up , when it is ready to receive the irradiated 18O-water and when the final FDG is ready (synthesized).
31
9
1
3
21
5
20
4
18
6
17 16
15
14
13
22
12
23
24
1
11
Front view without the front cover and without the white lead piece matching the cassette.
32
N Name and description
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
Radiation detector # 1: behind the anion exchange cartridge.

Rotating actuator # 1 (the actuators are numbered from the left to the right).
18O-Water recovery fitting: sets the 18O-water recovery vial to vacuum.
Clamps: hold the cassette in place.
Heater equipped with a radiation detector (# 2): contains the reactor vessel.
Radiation detector # 3: behind the tC-18 cartridge used for hydrolysis.
Cavity equipped with a radiation detector (# 4): housing for the vial that will receive the final FDG.
Rotating actuator # 15 (the actuators are numbered from left to right).
Lead shielding: closely matches the cassette.
Cassette holder: maintains the cassette in place during synthesis.
Exhaust connector: female luer lock connector, connects the cassette to the TRACERlab MX FDG - sets
the cassette to vacuum and drains the fluids to the waste.
Vacuum adjustment potentiometer.
Mechanical vacuum gauge.
Syringe driver # 3 (30 ml).
3 light indicators: inform the operator when the TRACERlab MX FDG is powered up, when it is ready to
receive the irradiated 18O-water and when the final FDG is ready (synthesized).
Clamp button: actuates the clamps and moves the elution system down onto the reservoir of the cassette.
Screws: to adjust the height of the water bag hook.
Hook: to attach the water bag.
Elution system containing a pinch valve and a conical block, fitting onto the reservoir of the cassette
18F inlet valve: 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 it.
Permanent tube providing pressure and vacuum to the elution system and the reservoir of the cassette.
Connected between the front panel and the elution system.
Pressure inlet connector: female luer lock connector connects the cassette to the TRACERlab MX FDG supplies gas (nitrogen) to the left of the cassette.
33
6. Rear view, central part of the TRACERlab MX FDG

The electronic and electric parts are gathered in the central part of the TRACERlab MX
visible from the rear when the cover is removed :
- PLC, with 32 + 16 logical outputs, 16 logical inputs and 3x4 analog inputs;
- 24 Vdc, 150 W supply, used to energize all the PLC outputs and the syringe actuators;
- Solid state relay that controls the heater resistance;
- 3 subassemblies of rotating actuators, and related valve manifolds;
- 3 linear drive boards, with electric motor (syringe drivers);
- 1 pneumatic linear motion board for the reservoir cap;
- 1 transformer for the TRACERlab MX FDG to be powered at 115Vac.
1
FDG
. Most of them are
11
10
15
14
13
16
34
12
17
18
19
20
21 22
23
24
25
26
27
1
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.
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.
35
7. Left side view (as seen from the front)

The nitrogen supply circuit and the compressed air supply circuit are gathered together on this left panel. Nitrogen
is used as a synthesis gas and compressed air is used to actuate the pneumatic parts of the TRACERlab MX FDG.
11
10
6
7
8
36
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.
7.1 Nitrogen supply circuit
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.
7.2 Compressed air supply circuit
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.
37
8. Right side view of the TRACERlab MX FDG

All devices related to waste collection are located on or near the right side panel
- The pump that creates vacuum,
- The valve that isolates the module from the external exhaust tube,
- The electronic vacuum gauge, which controls the pump and the valve.
4
38
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.
39
9. Top view of the TRACERlab MX FDG

N
1
2
3
4
5
6
7
8
9
Name and description

Mechanical vacuum gauge.
Hook : to attach the water bag.
Elution system pneumatic actuator : moves the elution system front piece down onto the reservoir of the
cassette.
18F inlet valve : see section relating to the front view
Power supply : 24 Vdc, 150 W supply, used to energize all the PLC outputs
PLC : Programmable Logical Controller
40
Chapter 6 : Maintenance mode

The maintenance mode allows to act upon any component of the TRACERlab MX FDG : rotating valve actuators,
internal valves, syringe actuators, heater, vacuum pump and clamps holding the cassette in place. This operating
mode is used to check the proper functioning of these components.
The disposable synthesis cassette is also called kit. The term kit is generally used in the user interface
software, rather than cassette.
1. Setting of the TRACERlab MX FDG to the maintenance mode

On the Windows desktop, double-click on the FDG supervision software shortcut. This will launch the FDG
supervision program, and all necessary associated software components.
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.
41
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.
42
2. Activation of the rotating valve actuators

There are 15 pneumatic rotating actuators allowing the rotation of the disposable valves of the cassette. All
these valves are aligned on the axis of the cassette when not activated. Each actuator can turn by 90, but only in
one direction : either to the left, or to the right (except for the second actuator, see below). To activate a rotating
actuator click on the corresponding rotating valve displayed on the screen. When activated, the corresponding
valves become green.
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.
3. Activation of internal valves

There are 11 internal valves which can be activated through the maintenance mode :
18F inlet pinch valve (normally open) : inlet of irradiated 18O water containing the 18F ions (connection to the
conical reservoir of the cassette)
Vac valve (normally closed) : valve allowing to set the conical reservoir of the cassette to vacuum (connection
with the waste bottle)
LP valve (normally closed) : valve allowing the pressurizing of the conical reservoir of the cassette at a low
pressure level
HP valve (normally closed) : valve allowing the pressurizing of the conical reservoir of the cassette at a high
pressure level
LF valve (normally closed) : valve supplying nitrogen to the cassette inlet at the low flow-rate level (and at a
high pressure level)
HF valve (normally closed) : valve supplying nitrogen to the cassette inlet at the high flow-rate level (and at
a high pressure level)
Nitrogen valve (normally open) : main nitrogen supply valve
Compressed air valve (normally open) : main compressed air supply valve
Eluent valve (normally closed) : valve connecting the eluent vial to the conical reservoir of the cassette
Vacuum 18O water valve (normally closed) : valve allowing to set the enriched 18O water recovery vial to
vacuum (connection with the waste bottle)
43
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.
4. Operation of the syringe drivers

There are 3 syringe drivers on the front panel of the TRACERlab MX FDG :
Two syringe drivers for 30 ml syringes equipped with a hooking mechanism, allowing the syringe piston to be
pushed and pulled.
One syringe driver for a 3 ml syringe. This syringe driver allows the syringe piston to be pushed only.
The position of the syringe drivers is given in mm above the empty position (piston down to the bottom). The
range for the position of the syringe drivers is between 0 and 92 mm.
These syringe drivers can be operated in 2 ways :
1. Drag the syringe piston to the chosen position
Drag the syringe piston
2. Enter the chosen position in the setpoint field of the corresponding position dialog box.
Enter a position setpoint
44
5. Operation of the heater

To operate the heater, enter the chosen temperature (between 0 and 200 C) in the Setpoint field of the
Temperature dialog box. The current measured temperature is displayed in the field below the setpoint.
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.
6. Operation of the vacuum pump

The vacuum pump allows to set the waste bottle to vacuum. To operate the vacuum pump, enter the chosen
vacuum level (between -1 and 0 bars) in the Setpoint field of the Pressure dialog box. The current measured
vacuum is displayed in the field below the setpoint.
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
45
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.
8. Resetting of the outputs

The Reset outputs button in the lower right-hand corner, allows the operator to de-energize all the outputs and
reset the setpoints to zero
46
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
1. Routine calibration procedure

It is recommended that a routine calibration of the four activity detectors is carried out at least once a year, during
the yearly maintenance of the TRACERlab MXFDG.
For the calibration of the detectors, it is necessary to accurately measure the activities using a calibrated dose
calibrator and to write down the measured values as well as the time of measurement. Make sure that the time
on the clock used for these measurements corresponds to the time given on the PC with the FDG supervision
software.
If some decimal values are not properly accepted while performing the calibration, this is related to the decimal
separator fixed in the Windows regional settings. Choose a dot as a decimal separator in the Windows settings.
To carry out the calibration proceed as follows :
1. Perform a hot run with a starting activity level close to the average routine production level. It is not necessary
to perform a special run uniquely for the calibration of the detectors. The calibration of the detectors can be
done with a routine FDG production run. Note that the fourth detector, measuring the activity in the FDG
solution, can only be calibrated if the final product vial is located in the relevant cavity.
2. After synthesis save the report. Do not start a new FDG synthesis before completion of the calibration
procedure.
47
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.
48
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.
49
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.
Additional radiation safety recommendation :

The FDG synthesis for calibration purpose should be performed as early as possible in the morning and the
measurement of the activity as late as possible in the evening to allow the activity to decay. For example, if
the run is performed at 6:00 in the morning with 1000 mCi, there would be about 11 mCi left at 18:00 in the
evening. The activity will be distributed approximately as follows : about 60 % in the FDG vial, about 35 % in
the waste bottle and about 5 % (usually less than 3 %) on the different cassette components. For each item, the
activity measurement can be done in a few seconds. Normally the dose calibrators are shielded and thus there
is exposure only while putting the item into the dose calibrator and while removing it.
Before starting the FDG synthesis, ensure that the waste bottle is properly shielded (within the hot-cell) to
avoid unnecessary exposure while removing the cassette from the synthesizer at the end of the day.
Check that the waste bottle fits into the dose calibrator. If not, the waste fluids have to be transferred into
another vial fitting into the dose calibrator.
After opening the hot cell at the end of the day, the first thing to do is to remove the FDG vial from its
location in front of the detector (cavity on the front of the TRACERlab MX FDG) and to place it into a shielded
container.
After removal of the cassette and disconnection of the waste bottle, place the cassette and the waste bottle into
a shielded container until measurement of the residual activity.
2. Manual calibration procedure

The slopes can also be adjusted manually. To estimate a new slope, the activity measurement displayed on the
screen must be compared with the real activity on the corresponding element, measured with a dose calibrator. To
50
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.
51
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.
3. Setting the four activity detectors to zero

The activity detectors might give an activity measurement, even in the absence of any source of activity, due to
a drift of the detectors electrical output depending on environmental parameters such as temperature. Therefore
before each synthesis the background is measured and all the activity measurements are automatically set to
zero and the drift is corrected at the beginning of the FDG production process, thus it is not necessary to set the
activity readings to zero manually.
The activity detectors can be forced to zero (taking into account the background and correcting the drift) by
pressing the Zero activity calibration of all detectors button in the Calibration window.
4. Display the detectors slope and offset

The detector slope and offsets can be displayed by pressing the Display detector slopes and offsets button in
the Calibration window.
52
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.
5. Adjustment of the detector positioning in the case of saturation

At high activity levels, i.e. several curies of starting activity, the activity detectors might saturate. In this case
the activity measurement displayed on the screen will not exceed a certain value, whatever the level of activity
in front of the detector.
In the case of saturation of the detectors, the distance between the detector and the radioactive source has to be
increased. Refer to the procedure MR-001-011, of the appendix, to adjust the position of the activity detectors

53
54
Chapter 8 : weekly maintenance

Every week it is recommended to carry out a preventive maintenance on the TRACERlab MX FDG. This weekly
maintenance consists of the replacement of the silicone tube from the eluent pinch valve.
The dimensions of the tube from the eluent pinch valve are : inner diameter = 0.58 mm, outer diameter = 2.4 mm,
length = 100 mm. Refer to the procedure MR-001-003 in the appendix of this manual
Important notes :
To avoid the tube remaining pinched where it is in the pinch valve, it is strongly recommended to carry out one
of the following procedures between 2 syntheses :
1. move the tube within the pinch valve by a few mm before each FDG production.
2. take the tube out of the pinch valve (but leave the tube connected onto the elution system) between two FDG
productions. Ensure that the tube is placed back into the pinch valve before the next FDG synthesis.
It is also recommended to remove the tube from the valve when the equipment is not used for more than one
week.
Some Kryptofix or potassium carbonate from the eluent mixture may crystallize and accumulate in the silicone
tube of the eluent pinch valve, which may lead to an obstruction of the tube. It is recommended that the tube is
replaced as soon as white residues are noticed.
The tube should be replaced as soon as it is seen that the eluent vial is not completely empty after a synthesis, i.e.
as soon as you notice that the tube remains pinched where it had been in the valve.
55
56
Chapter 9 : Yearly maintenance

It is recommended that maintenance and verification are carried out once a year on the TRACERlab MX FDG. This
yearly maintenance consists of, the replacement of the silicone tubes from the pinch valves, the replacement of the
tubes connecting the external waste bottle to the TRACERlab MX FDG, the checking of the TRACERlab MX FDG,
the replacement of worn parts (if needed) and finally, the calibration of the four activity detectors.
In the case where a component is worn or broken and has to be replaced, refer to the Maintenance and Repairing
procedures given in the appendix.
1. Replacement of the tube from the eluent pinch valve

The dimensions of the tube from the eluent pinch valve are : inner diameter = 0.58 mm, outer diameter = 2.4 mm,
length = 100 mm. Refer to the procedure MR-001-003 in the appendix of this manual
Important note :
To avoid the tube remaining pinched where it is in the pinch valve, the tube has to be moved within the pinch valve
by a few mm before each FDG production. It is very important to perform this operation before each run and to
replace the tube monthly. If these operations are not carried out, the eluent may not be transferred to the reservoir,
leading to a failure of the FDG synthesis (refer also to the Troubleshooting section).
tube of the eluent pinch valve, which may lead to an obstruction of the tube. It is recommended that the tube is
replaced as soon as white residues are noticed.
The tube should be replaced as soon as it is seen that the eluent vial is not completely empty after a synthesis, i.e.
as soon as you notice that the tube remains pinched where it had been in the valve.
2. Replacement of the tube from the 18F inlet pinch valve

The dimensions of the tube from the activity inlet pinch valve are : inner diameter = 1 mm, outer diameter = 3
mm, length = 55 mm. Refer to the procedure MR-001-002 in the appendix of this manual.
Important note :
Radioactive target impurities with a long half-life may accumulate over time on the silicone tube of the 18F inlet
pinch valve. It is recommended that the tube is replaced as soon as the permanent radiation level on the tube
becomes too high. 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. To reduce the permanent
radiation level on this tube it is recommended that the area on which target impurities can accumulate is reduced
by using a tube as short as possible.
3. Replacement of the waste cap and waste tube

Replace the waste cap and the silicone tube connecting the external waste bottle to the TRACERlab MX
FDG
57
(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.
4. Checking the TRACERlab MX FDG

The tests described below can be carried out remotely using the maintenance mode, without needing to take the
TRACERlab MX FDG out of its hot cell. Refer to the chapter concerning the maintenance mode for more details. A waste
bottle has to be connected, and compressed air and nitrogen have to be supplied to the TRACERlab MX FDG for all these
tests.
The following accurate and calibrated tools are needed for checking the TRACERlab MX FDG : a flow-meter for
the range between 0 and 50 ml/min, a flow-meter for the range between 0 and 1000 ml/min, a manometer for
the range between 0 and 1 bar, a vacuometer for the range between 1 an 0 bar and a thermometer for a range
between 0 and 100 C.
Replace parts only if the acceptance criteria are out of the given range. Refer to the procedures in the appendix
for the replacement of worn parts, or contact the supplier or manufacturer of the equipment.
The valve numbering in the diagram below corresponds to the numbering of the electric scheme in the
appendix.
1-15
1-16
1-17
1-23
1-18
1-20
1-19
2-5
2-3
1-21
2-1
58
4.1 Checking the valve connected to the pump (valve 2-1)
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.
4.2 Checking the electronic vacuum gauge
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.
59
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.
4.3 Checking the vacuum pump
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
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
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
61
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).
4.8 Checking the Vac valve (valve 1- 17)
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).
4.9 Checking the Vacuum to 18O water valve (valve 1-21)
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).
4.10 Checking the kit exhaust valve (valve 1-24)
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).
4.11 Checking the eluent valve (valve 1-15)
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).
4.12 Checking the 18F inlet valve (valve 1-16)
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).
4.13 Checking the heater temperature
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
62
temperature displayed on the screen is acceptable. If the heater or the thermocouple is defective, contact the
supplier or manufacturer of the equipment.
4.14 Checking the syringe drivers
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).
4.15 Checking the position of the 3 ml syringe driver
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
63
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
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
5. Calibration of the detectors

Refer to the chapter specifically about the calibration of the activity detectors in this manual. In the case of a
defective activity detector, contact the supplier or manufacturer of the equipment.
64
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
Vacuum set-point (bar)
Value displayed on the user

interface screen (bar)
Value measured through an

external calibrated vacuometer
(bar)
The electronic vacuum gauge is working properly

There was no significant drift of the vacuum measurement. The difference between the vacuum

displayed on the screen and the vacuum measured through an external calibrated vacuometer is below

0.05 bar. No adjustment had to be done
There was a drift on the vacuum measurement. The difference being > 0.05 bar (> 50 mbar), the vacuum
measurement was adjusted. After adjustment the difference between the vacuum displayed on the screen
and the vacuum measured through an external calibrated vacuometer is below 0.05 bar

(cf measurements here below)
Vacuum set-point (bar)
Value displayed on the user

interface screen (bar)
Value measured through an

external calibrated vacuometer
(bar)
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)
65

66
The Vac valve (valve 1- 17) is operating properly

The Vacuum to 18O water valve (valve 1-21) is operating properly
The kit exhaust valve (valve 1-24) is operating properly
The eluent valve (valve 1-15) is operating properly
The 18F inlet valve (valve 1-16) is operating properly
The heater is operating properly, a temperature of 80C has been reached after _______ sec on the user
interface screen (less than 60 sec) and the temperature reached in 3 ml of water after 3 minutes was ______ C
(between 75 and 85C, measured with an external calibrated thermometer)
The left hand side 30 ml syringe driver is working properly
The right hand side 30 ml syringe driver is working properly
The 3 ml syringe driver is working properly
The positioning of the 3 ml syringe driver is correct
No adjustment had to be done on the positioning of the 3 ml syringe driver
The positioning of the 3 ml syringe driver had to be adjusted
The Compressed air valve (valve 2-3) is operating properly
The rotating actuator 1 is operating properly
The clamp kit (clamp cassette) mechanism is operating properly
Chapter 10 : Extensive maintenance

after 3 years
After 3 years, it is recommended that extensive maintenance, i.e. an overhaul, is carried out on the
TRACERlab MX FDG. This extensive maintenance can only be done by personnel qualified by GE Medical
Systems. It typically consists of the replacement of the internal tubing, replacement of the vacuum pump
diaphragms, replacement of the nitrogen and compressed air filters, replacement of the CPU battery, replacement
of worn or weak parts, a hardware and/or software upgrade and a general extensive check of the synthesizer after
maintenance. Contact the supplier or manufacturer of the equipment.
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68
Chapter 11 : Cleaning and sanitizing

In the case of liquid spillage on the TRACERlab MX FDG, cut off the power supply and wipe it off. If the liquid
is radioactive, wait until the radioactivity has decayed. Liquid spillages may contain radioactive, caustic or toxic
substances. Use protective gloves while wiping off liquid spillages.
Since the chemicals involved in the FDG synthesis and the final FDG solution come in contact only with the
single use cassette, there is no need to clean or sanitize the TRACERlab MX FDG.
To clean the TRACERlab MX FDG cut off the power supply and wipe the TRACERlab MX FDG using a tissue
wetted with isopropanol or water. Never spray isopropanol directly onto the TRACERlab MX FDG. Isopropanol
or water entering into the slots of the syringe driver or any other opening on the TRACERlab MX FDG may
cause a short circuit. Isopropanol or water entering into the connectors on the front panel, where the cassette is
connected, may cause a yield drop on the following production runs.
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70
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.
1. Error detected during the synthesizer test

The synthesizer test checks:
that the heater is operational,
that the syringe actuators are functional,
that air and gas are supplied at a sufficient pressure level.
In the case of a malfunction, a red indicator will show which abnormality has been detected. In such a case, the
synthesizer test has to be restarted after solving the problem.
1.1 Heater error
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.
71

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.
1.3 Compressed air error
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.
1.4 Nitrogen error
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.
2. Syringe driver error

If a movement of a syringe driver is blocked for whatever reason, the blocked syringe driver will pass into an error state,
and the relevant syringe will be displayed blinking in red on the screen. Such a syringe driver error may occur in the
maintenance mode or during the FDG synthesis process. During the synthesizer test the operator will be informed by a
red light signal in the synthesizer test box if the syringe driver error occurs during the synthesis, the synthesis will be
aborted automatically.
72
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.
3. Error detected during the cassette test

The cassette test (i.e. the kit test) is based on vacuum
maintained in the cassette during a limited time
interval, for separate sections of the circuit (cassette,
waste bottle and water recovery vial). A given section
is isolated using the valves and vacuum is applied to
this section. The vacuum level is given 15 seconds
to even-out within the section. The vacuum level is
measured first at this instant and again 3 seconds later.
A loss of vacuum is considered as a leak when the rate
of change of vacuum level is higher than 5 mbar in
3 seconds (about 1.5 mbar/sec). In the case of a leak,
the operator will be informed about the most probable
location of the leak in order to allow corrective actions
(e.g. check a given connection on the cassette) and the
cassette connection test has to be started again.
In the case of repetitive and systematic errors during the cassette test with several cassettes (leak detected mainly on the
waste recovery connection), replace the waste bottle cap and the tube connecting the waste bottle to the TRACERlab
MX FDG, since the cap and tube may age, leading to leaks. If the leak persists, there might be a leak in the internal tubing
of the TRACERlab MX FDG. In such a case, contact the supplier or manufacturer of the equipment.
73
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.
There are other possible origins for such a kind of error :

One of the silicone tubes of the cassette is either pinched between the transparent cassette retainer and the front
panel or pinched by the clamp holding the cassette in place.
The tube leading to the waste bottle is squeezed.
A larger waste bottle is used instead of the 250 ml bottle recommended in the user manual.
There is a drift on the electronic vacuum gauge. The pressure given in the supervision screen is different than
the vacuum measurement given by the mechanical vacuum gauge on the front panel of the module 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.
The electronic vacuum gauge is defective. In the case of a defective electronic vacuum gauge, replace the
vacuum gauge according to the procedure given in the appendix.
The Nitrogen valve (valve 2-5), the HF valve (valve 1-19), the LF valve (valve 1-20), the HP valve (valve
1-18) or the Vac valve (valve 1-17) is defective. Check these valves in the maintenance mode as described
in the Yearly maintenance section of the this manual. In the case of a defective valve, replace the valve
according to the procedure given in the appendix.
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
74
the valve according to the procedure given in the appendix.

5.2 The mannose triflate precursor was not diluted properly
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
6. Low yield (< 45%EOS)

Be aware that the activity measurements done by the built-in detectors and the yield as mentioned in the synthesis
report are meaningful only if the detectors are well calibrated. The measurements done by the activity detectors
should be considered only as indicative since the accuracy of such type of detectors is limited. To determine
the yield in the most precise manner, the starting activity as well as the activity in the FDG solution should be
measured accurately using a dose calibrator.
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
The QMA cartridge was not conditioned properly.

The QMA cartridge is defective (for example, not filled enough with anion exchange resin). In such a case, the
flow-rate should be abnormally high during conditioning.
The eluent pinch valve is leaking or the tube was not placed properly in the pinch valve, so some of the eluent
75
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
76
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

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.
77
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.
78
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.
79
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
80
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) :
81
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.
9. Other possible explanations for low yields or a failed synthesis

Some operator errors or malfunctions leading to failures at various steps of the synthesis.
The waste bottle is full. To avoid this, it is recommended that an empty waste bottle is used for each
synthesis.
The tube leading to the waste bottle is squeezed.
The cassette is not properly connected to the TRACERlab MX FDG (this is normally detected during the cassette
test before synthesis).
Some silicone tubes of the cassette are squeezed during the cassette installation. Silicone tubes are pinched
between the reservoir and the elution system or pinched by the clamps holding the cassette in place.
Some silicone tubes are partially damaged (especially at their extremities where the barbed fitting is connected).
This is normally detected during the cassette test.
The nitrogen or compressed air pressure at the inlet to the TRACERlab MX FDG is too low (this is normally
detected during the synthesizer test). Nitrogen pressure must be higher than 2 bars, and compressed air pressure
higher than 5 bars. If only nitrogen is used for both, the pressure must be higher than 5 bars.
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
82
as described in the Yearly maintenance section of this manual.

The electronic vacuum gauge is defective. In the case of a defective electronic vacuum gauge, replace the
vacuum gauge according to the procedure given in the appendix.
The vacuum pump is weak or defective. Check the pump in the maintenance mode as described in the Yearly
maintenance section of this manual. In the case of a weak or defective pump, replace the pump according to
the procedure given in the appendix.
One of the valves located inside the TRACERlab MX FDG is defective. Check the valves in the maintenance
With stoppers other than the one recommended in the user manual, leakages of reagents may happen through
the piercing hole.
The rotating actuators do not work. This is generally due to a too low pressure of compressed air supplied
to the TRACERlab MX FDG. This may happen when there is a large and sudden drop in the pressure of the
compressed air during synthesis (for example, if there are other devices connected to the same compressed
air supply). This can lead to various types of failures at different steps of the synthesis. In the case where the
rotating actuators do not work, although the compressed air pressure is high enough, contact the supplier or
10. The quality of the final product does not meet the pharmaceutical requirements

10.1 The pH is too high (> 8.5)
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.
10.2 The pH is too low (< 4.5)
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
83
solution is too low.

The amount of sodium hydroxide injected into the cartridge is lower than 700 l. Adjust the position of the
syringe driver as described in the Yearly maintenance section of this manual.
The syringe containing sodium hydroxide was not properly connected to the cassette. Some sodium hydroxide
leaked out of the cassette.
10.3 The FDG solution is not clear and colorless
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.
10.4 There are unknown radioactive impurities in the FDG 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.
10.5 The amount of residual free 18F ions is abnormally high
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
84
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.
10.6 The amount of partially hydrolyzed labeled precursor is abnormally high
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)
85
86
Chapter 13 : Report analysis

In the case of an [18F]-FDG synthesis with a lower yield (below 45% EOS yield, not corrected for decay) the
synthesis report can help to track down the problem. This requires the activity detectors to be properly calibrated
(refer to the chapter on detector calibration in this manual)
The present chapter and the chapter specifically about troubleshooting are complementary. Refer also to the
chapter describing the chemical process and to the chapter concerning the synthesis report in the TRACERlab
MX FDG : Operator Manual.
An example of a typical synthesis report is given at the end of the chapter.
1. Enriched 18O-water recovery

If the activity, trapped on the anion exchange cartridge (QMA cartridge), i.e. the activity measured by the Recovery
cartridge detector, after enriched 18O-water recovery is much lower than the activity expected according to the
irradiation parameters, measure the amount of activity in the enriched 18O-water recovery vial after synthesis.
Normally the losses during this activity trapping step are less than 1 % of the inlet activity. If the lost activity is
much higher than that, refer to section 6.1 of the chapter specifically about troubleshooting in this manual.
After elution to the reactor, there should be almost no more activity detected by the Recovery cartridge detector
and the activity measured by the Reaction vial detector should be around 99 % of the activity trapped on
the recovery cartridge just before, after enriched 18O-water recovery. If there are high losses on the 18O-water
recovery cartridge, refer to section 6.3 of the chapter specifically about troubleshooting in this manual.
2. Labeling of the precursor and prepurification

The activity measured by the Hydrolysis cartridge detector after transfer via the tC18 cartridge (i.e. after
labeling and trapping of the labeled intermediate onto the hydrolysis tC18 cartridge) should be around 70 % of
the activity measured by the Reaction vial detector at the end of the labeling reaction. If the amount of activity
trapped on the hydrolysis cartridge is much lower than that, this may result from a poor labeling yield (refer to
section 6.4.1 of the chapter specifically about troubleshooting in this manual) or from a poor trapping efficiency
on the hydrolysis tC18 cartridge (refer to section 6.4.2 of the chapter specifically about troubleshooting in this
manual).
Note that a poor labeling yield is the most frequent reason for a poor overall yield.
3. Hydrolysis, purification and transfer to the final vial

The activity measured by the FDG vial detector after transfer to the FDG vial should be around 97 % of the
activity measured by the Hydrolysis cartridge detector at the end of hydrolysis. If an important fraction of the
activity trapped on the hydrolysis tC18 cartridge is not eluted out of the cartridge and transferred to the FDG vial,
refer to section 6.6 of the chapter specifically about troubleshooting in this manual.
87

88
Chapter 14 : General check procedure

in the case of low yields
The usual FDG synthesis yields obtained with the TRACERlab MX FDG are the following: 50 % EOS Yield
(End Of Synthesis Yield , i.e. not decay corrected) and 60 % SOS Yield (Start Of Synthesis Yield, i.e. decay
corrected).
The aim of this procedure is to provide recommendations to pinpoint the origin(s) of low yields obtained with the
TRACERlab MX FDG system. These guidelines are complementary to the information provided in the chapter 11
and chapter 12 of the TRACERlab MX FDG : Service manual.
Check that the four built-in activity detectors are well calibrated. The activity measurements during the
synthesis are summarized in the synthesis report, as a table and as a graphical representation. Find an example
of a typical synthesis report in Chapter 12 : Report analysis of the TRACERlab MX FDG : Service manual.
In the case the activity detectors are not properly calibrated, refer to Chapter 6 : Calibration of the activity
detectors of the TRACERlab MX FDG : Service manual. Even if these detectors are well calibrated, their
accuracy is limited (about 10 % accuracy). Therefore an accurate determination of the yields is possible only
by measuring accurately, i.e. with a dose calibrator, the starting activity and the activity in the FDG solution at
the end of the process. An accurate yield determination can be done in the scope of a low activity synthesis as
explained below.
Check the proper functioning of the TRACERlab MX FDG using the procedure given in Chapter 8 : Yearly
maintenance of the TRACERlab MX FDG : Service manual. If no parameter is out of specification, the origin
of the low yield is probably not related to a mechanical failure of the equipment but to external parameters. A
toolbox with all instruments needed for this check is available (cat Number 2373000)
Track for any change in the FDG production, which occurred just before the yield became low : use of new
batch of reagents (new lot or new supplier), change of the inert gas involved in the chemical process (nitrogen,
argon) bottle, change of the enriched 18O-water quality or supplier, maintenance on the cyclotron target,
maintenance on the TRACERlab MX FDG, change of the tube used to transfer the irradiated 18O-water from the
target to the synthesizer, change of the tube supplying gas (nitrogen) to the TRACERlab MX FDG, change in the
internal procedures used by the operator for the FDG production, any change may be the origin of lower
yields, even if the causality relationship is not obvious or if there seems to be no possible effect.
Use the troubleshooting procedure to analyze the origin(s) of the low yields. Refer to Chapter 11 : troubleshooting
of the TRACERlab MX FDG : Service manual. The analysis of the synthesis report may also be useful if the
activity detectors are well calibrated. Refer to Chapter 12 : Report analysis of the TRACERlab MX FDG :
Service manual.
Check the influence of the reagent set quality. Perform a synthesis using the reagent sets supplied by ABX
advanced Biomedical Compounds GmbH. Refer to Chapter 4 : reagent sets of the TRACERlab MX FDG:
Consumable manual. One may perform a low activity run as explained above to determine accurately the
yields.
89
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.
90
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.
91
92
Chapter 15 : Remote control box

The Remote Control Box allows the operation of the TRACERlab MX FDG, even without a PC . It is connected to
the Remote control 8 terminal connector located at the rear of the TRACERlab MX FDG. This terminal can also
be used to get a 24 Vdc signal when the TRACERlab MX FDG is ready to receive the activity (between the OV
terminal and the READY FOR ACT. terminal) or when the FDG is ready (between the OV terminal and the
PROD. READY terminal). Refer to the TRACERlab MX FDG : Preinstallation and Installation Manual for
more details.
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.
How to use the Remote Control Box :

Firstly, the TRACERlab MX FDG has to be reset by pressing the Clamp/Reset button on the Remote Control
Box for at least 5 seconds - this can also be done by pressing the Clamp/Reset button on the front panel of
the TRACERlab MX FDG. Install the cassette and activate the clamps. The cassette can be clamped by briefly
pressing the Clamp/Reset button of the Remote Control Box (less than 5 seconds), but it is recommended that
the clamp button on the front panel of the TRACERlab MX FDG is used to ensure that no tube of the cassette is
squeezed. Start the preliminary steps of the synthesis by pressing the start button for at least 2 seconds . After
completion of the preliminary steps, the Ready to R. Act. light signal will inform you that the TRACERlab MX
is ready for the transfer of the irradiated 18O-water from the target. As soon as the arrival of the activity has
FDG
been observed, press on the red start button to proceed with the synthesis. The FDG Ready light signal will
inform you that FDG is ready. After the rinsing steps, reset the system.
93
94
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 elution system tube inserts (on the conical block)
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 the PLC power supply
Replacement of the CPU battery
Replacement of the mains 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.
95
MAINTENANCE & REPLACEMENT
MR-001-001
Removal of the cover

TOOLS
1 flat-headed screwdriver ( 8 mm )
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
96
Version II - Last Update : October 2004
MR-001-002

TOOLS
No tool is needed for this operation
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.
Insert the silicone tube into the pinch valve.
Connect the other end of the silicone tube

to the line leading from the cyclotron to the
TRACERlab MX FDG.
Using the maintenance mode, check that the tube is pinched properly when the valve is activated, and that the tube
returns to normal shape when the valve is deactivated.
Important note :
This tube should be replaced during the yearly maintenance procedure.
Radioactive target impurities with a long half-life may accumulate over time on the silicone tube of the 18F
inlet pinch valve. It is recommended that the tube is replaced as soon as the permanent radiation level on the
tube becomes too high. 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. To reduce
the permanent radiation level on this tube it is recommended that the area on which target impurities can
accumulate is reduced by using a tube as short as possible.
97
MR-001-003

TOOLS
MATERIAL
Silicone tubing, ID (Inner Diameter) = 0.58 mm
OD (Outer Diameter) = 2.4 mm, length 100 mm
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.
Insert the silicone tube into the pinch valve.

Using the maintenance mode, check that the tube is pinched properly when the valve is deactivated, and that the
tube returns to normal shape when the valve is activated.
Important note :
It is very important to perform these operations before each run and to replace the tube weekly. If these
operations are not carried out, the eluent may not be transferred to the reservoir, leading to a failure of the
FDG synthesis (refer also to the Troubleshooting section).
tube of the eluent pinch valve, which may lead to an obstruction of the tube. It is recommended that the tube
is replaced as soon as white residues are noticed.
The tube should be replaced as soon as it is seen that the eluent vial is not completely empty after a synthesis,
i.e. as soon as you notice that the tube remains pinched where it had been in the valve.
98
MR-001-004
Replacement of the elution system inserts (on the conical block)

TOOLS
1 pair of pliers
1 tube cutter or another sharp tool allowing to cut tubing
MATERIAL
PEEK tubing, ID (Inner Diameter) = 0.8 mm and
OD (Outer Diameter) = 1.6 mm
PROCEDURE
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.
99
MR-001-005

TOOLS
1 flat-headed screwdriver (6 mm)
MATERIAL
Elution system with pinch valve and tubing
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.
Eluent valve cables

Protection sheath
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).
100
MR-001-005A
Using the flat-headed

screwdriver, unscrew the
bolt fixing the elution
system onto the front
panel.
Teflon tubing
Male luer lock
Remove the elution

system and pull the wires
out of the hole on the
front panel.
101
Mount the new elution

system as described below.
Pass both wires of the
elution pinch valve
through the hole on the
front panel. Keep the wires
behind the front panel
together using a sheath, to
avoid damage to the cables
when the elution system
moves up and down.
102
MR-001-005A
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.
103
MR-001-006

TOOLS
MATERIAL
Electronic vacuum gauge used for the regulation of
vacuum. Gives the vacuum value as displayed on the
user interface screen
Electronic vacuum gauge, 2333424
PROCEDURE
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.
Electronic vacuum gauge
104
MR-001-006
Disconnect the silicone tube from the barbed

fitting on the bottom.
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).
105
MR-001-008

TOOLS
MATERIAL
Double-head membrane vacuum pump
Vacuum pump, 2333426
PROCEDURE
Take out the worn pump, as described below.
Exhaust tubing
From waste tubing
Identify the two silicone tubes connected to the pump : From waste tube and Exhaust tube.
Disconnect the silicon tubes fixed to the pump.
106
MR-001-008
Take the pump out of the rubber retainer.
Identify the wires leading to the pump in the

wire-channel near the vacuum pump, give the
wires some slack which will allow you to take
the pump out of the TRACERlab MX FDG, so
that easy access can be gained to the quickconnector at the rear of the pump.
Disconnect the quick-connector at the rear

of the pump. For some older versions of the
TRACERlab MX FDG, there is no quick-connector
and the wires have to be cut.
Quick connector
107
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.
108
MR-001-009

and position adjustment
TOOLS
1 flat-headed screwdriver ( 8 mm)
1 Phillips (cross-headed) screwdriver (2)
1 Allen key (2,5 mm)
MATERIAL
Syringe driver consisting of a control card, DC
motor, and pulley transmission to the guided linear
unit
Syringe actuator mechanism
(without front piece), 2333632
If the front piece also has to be replaced, the following item is required :
Font piece for 30 ml syringe driver, with spring
allowing hooking onto the syringe piston
Syringe push-pull hook front piece
(30 ml syringe), 2333633
PROCEDURE
Using the Allen key, unscrew the two screws located in the holes of the white cylindrical front piece.
Take out the syringe driver mechanism, as

explained below.
109
MR-001-009

Disconnect the orange electric connector
from the syringe actuator card.
With a flat-headed screwdriver (8 mm), unscrew

the upper screw on the water bag hook.
With a Phillips (cross-headed) screwdriver (2),

unscrew the aluminum bar on the upper rear side
of the front panel (two screws located on the left
and right hand side). Remove the aluminum bar.
110
MR-001-009
Slide the syringe driver card upwards and

remove it.
Fix the front piece on

the 2 upper screw
holes
Mount the new syringe actuator mechanism as

described below.
Slide the new syringe driver card into the
corresponding slot.
Fix the front piece using the Allen key. The two
Allen screws have to be screwed into the two
upper holes in the slot. No position adjustment
is needed.
Fix the front piece on the 2 upper screw holes
111
MR-001-009
Fix the aluminum bar
Connect the orange electric connector to the syringe actuator card.

112
MR-001-010

1 flat-headed screwdriver ( 8 mm)
1 Allen key (3 mm)
1 FDG synthesis cassette. A used cassette can be utilized.
1 syringe (3 ml) filled with 1 ml of water
MATERIAL
Syringe driver consisting of a control card, DC
motor, and pulley transmission to the guided linear
unit
Syringe actuator mechanism
(without front piece), 2333632
If the front piece also has to be replaced, the following item is required :
Font piece for 3 ml syringe driver, allowing only
pushing of the syringe piston
Syringe push front piece
(3 ml syringe), 2333634
PROCEDURE
Using the Allen key, dismount the front piece :

unscrew the two screws located in the holes.
113
MR-001-010

Take out the syringe driver mechanism, as
explained below.
Disconnect the orange electric connector from
the syringe actuator card.
With a flat-headed screwdriver (8 mm), unscrew

the upper screw on the water bag hook.
With a Phillips (cross-headed) screwdriver (2),

unscrew the aluminum bar on the upper rear side
of the front panel (two screws located on the left
and right hand side). Remove the aluminum bar.
114
MR-001-010

Slide the syringe driver card upwards and

remove it.
Mount the new syringe actuator mechanism as

described below.
Slide the new syringe driver card into the
corresponding slot.
Fix the front piece using the Allen key. The front
piece has to be screwed into two holes as shown
in the picture.
115
MR-001-010

Keep the front piece screwed onto the front panel

loosely, since the position of the front piece has
to be adjusted as described below.
Fix the aluminum bar
Connect the orange electric connector to the syringe actuator card.

Adjustment of the position of the front piece
Run the user interface software and set it to the maintenance mode.
Mount a cassette onto the TRACERlab MX FDG as explained in the TRACERlab MX FDG : Operator Manual.
Reagents are not necessary. Clamp the cassette.
Fix the 3 ml syringe filled with 1 ml of water on the proper position of the cassette.
116
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.
117
MR-001-010

With the Allen key, loosen the syringe push
front piece, but do not unscrew the two screws
completely.
Push the syringe push front piece down manually

so that the piston reaches a position between
200 and 300 l (the amount of liquid left in the
syringe).
Take care to hold the syringe push front piece in
place, exactly in this position, while tightening
the two screws.
118
MR-001-011
Adjustment of the activity detector position

in the case of saturation
In case of saturation of the activity measurement with starting activities of several Ci, the position of the
relevant activity detector has to be adjusted by increasing the distance between the detector and the radioactive
source, as explained below.
TOOLS
MATERIAL
PROCEDURE
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 :
Detector 1, behind the anion exchange QMA

cartridge
3
4
Detector 2, on the heater for labeling reaction

Detector 3, behind the tC18 cartridge
used for hydrolysis
Detector 4, near the cavity for the final vial
119
MR-001-011
Adjustment of the activity detector position

in the case of saturation
Loosen the relevant detector by unscrewing the knurled screw on the shielded
housing of the detector. Pull the detector by a few mm and fix it with the knurled
screw.
For detector 1, a screwdriver must be used (see

below).
Detector 1 can be loosened using a screwdriver
passed through a hole on the left side panel (facing
the TRACERlab MX FDG).
120
MR-001-012
Adjustment of the pressure levels :

High Pressure (HP) & Low Pressure (LP)
TOOLS
1 calibrated manometer (0-1 bar) with a male luer connector
This instrument is part of the calibration toolbox (ref.2373000)
MATERIAL
PROCEDURE
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.
Disconnect the tube used to pressurize or depressurize the

reservoir from the front panel (tube connected to the front
panel, below the activity inlet pinch valve).
121
MR-001-012

Purge the nitrogen circuit by opening the HP valve (or LP valve) for 15
seconds.
Adjust the pressure regulators located inside the

TRACERlab MX FDG on the left side (facing the
TRACERlab MX FDG) as described below.
HP regulator (0.7 bar)
LP regulator (0.4 bar)
122
MR-001-012

While the HP valve (or LP valve) is open, set the HP regulator to a
0 bar level, i.e. turn it anticlockwise until the value is 0.
Connect an external calibrated manometer to the female luer

connector located on the front panel, below the activity inlet pinch
valve.
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.
123
MR-001-013

and/or compressed air filter cartridge
TOOLS
One flat-headed screwdriver 5 mm
One flat-headed screwdriver 2 mm
One open-end wrench
MATERIAL
Cartridge for particles filtering (7 m)
from the nitrogen.
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
The nitrogen filter is located inside the TRACERlab MX FDG,

on the left side.
Using the flat-headed screwdriver, unscrew the two screws
fixing the filter to the side panel.
124
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.
On the other side of the nitrogen filter, disconnect the tube

from the white tube connector. Do not remove the tubing
Unscrew the cap anticlockwise and take off the cap of the
filter.
125
MR-001-013

Replace the cartridge filter (Component 00108) by the new
one.
Connect the filter to the tube on one side and to the valve on
the other side.
Fix the filter to the side panel.

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.
at the rear of the nitrogen filter. Push the connector towards
at the front of the nitrogen filter. Push the connector towards
directly from the connectors on the filter
126
MR-001-013

Holding the pressure filter in one hand, carefully unscrew the
tank containing the filter.
Unscrew the small plastic nut.
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.
127
128
MR-001-014

TOOLS
MATERIAL
24 Vdc solenoid valve with tubing connector and
electrical quick connector
Valve for internal tubing, 2333432
PROCEDURE
Carefully disconnect the tubes above and below
the concerned valve.
Disconnect the electrical quick connector. For

older versions of the TRACERlab MX FDG there
is no quick connector, so the wires have to be cut.
There is no polarity on the wires of the valve.
129
MR-001-014

Using a flat-headed screwdriver, unscrew
the two bolts fixing the valve onto the
frame of the TRACERlab MX FDG.
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.
130
MR-001-015

TOOLS
1 open-end spanner (30mm)
1 wire cutter, soldering material, insulating tape
MATERIAL
24 Vdc pinch valve for 3 mm OD and 1 mm ID
silicone tubing
Pinch valve for activity inlet, 2333425
PROCEDURE
With a flat-headed screwdriver (8 mm), unscrew the

upper screw on the water bag hook.
With a Phillips (cross-headed) screwdriver (2), unscrew

the aluminum bar on the upper rear side of the front
panel (two screws located on the left and right hand
side). Remove the aluminum bar.
131
MR-001-015
Remove the elution system (front piece). Refer to procedure

MR-001-003A
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.
Take the card out of the TRACERlab MX FDG.
132
MR-001-015
Unscrew the nut behind the pinch valve.
Take out the white cylindrical piece.

Cut the wire of the worn pinch valve.
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.
133
MR-001-016
Replacement of the PLC Power Supply

TOOLS
MATERIAL
Power supply unit powering the Programmable
Logical Controller (PLC) at 24 Vdc
PLC card : 2A Power Supply 120/240
Vac, 2333770
PROCEDURE
Remove the PLC power supply to be replaced, as described below.
Open the door of the PLC power supply, located on

the left-hand side of the PLC. Push the clips on the
lower right side to open the door.
With the screwdriver, unscrew the three wires (brown,
blue and yellow-green).
134
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
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 :
Close the door of the PLC power supply.

136
MR-001-017

TOOLS
1 flat-headed screwdriver ( 5,5 mm)
1 clamp collar
MATERIAL
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
24 Vdc Power supply, 2333599
PROCEDURE
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.
Disconnect the two electrical connectors

on the top of the 24 Vdc power supply
unit.
137
MR-001-017
Cut the clamp collar keeping the

wires together.
Unscrew the 24 Vdc power supply

unit (there are four flat-headed
screws fixing the power supply to
the side panel)
138
MR-001-017
Disconnect the electrical connector

at the bottom of the power supply
unit.
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.
139
MR-001-018
Replacement of the CPU Battery

TOOLS
MATERIAL
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
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.
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.
140
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
Unplug the battery connector.

Remove the battery from the retaining clips.
141
MR-001-018

Insert a new battery into the battery retaining clips.
Plug the battery connector into the socket.
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.
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
MR-001-019
Replacement of the mains fuse (IEC fuse)

TOOLS
MATERIAL
Fuse (2 A) for mains on IEC plug for an TRACERlab
MX FDG operated at 220 V
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
Fuse (3.15 A) for mains on IEC plug

for an TRACERlab MX FDG operated at 110 V

2 A and for mains on IEC plug 3.15 A), by lot of
5, 2357705
PROCEDURE
Pull the little drawer out, and replace the fuse.
Push the little drawer back in place.

Connect the TRACERlab MX FDG to the power supply.
143
MR-001-020

TOOLS
MATERIAL
Heater fuse (1 A) for an TRACERlab MX
operated at 220 V
Heater fuse (2 A) for an TRACERlab MX

operated at 110 V
1 A and for mains on IEC plug 2 A), by lot of
5, 2357707
5, 2357705
FDG
FDG
PROCEDURE
Unscrew the fuse box using a flat-headed screwdriver and

replace the fuse.
Screw the fuse box back in place.

Connect the TRACERlab MX FDG to the power supply.
144
MR-001-021

TOOLS
MATERIAL
Fuse in the Programmable Logical Controller (PLC)
power supply (3 A), for an TRACERlab MX FDG
operated at 220 V
1 A and for mains on IEC plug 2 A), by lot of 5,
2357707
Fuse in the Programmable Logical Controller (PLC)

power supply (3 A), for an TRACERlab MX FDG
operated at 110 V

5, 2357705
PROCEDURE
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.
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.
145
TRACERlab MX FDG
GENERAL ELECTRIC
MEDICAL SYSTEMS
BENELUX S.A.
General tubing diagram

TRACERlab MX FDG
GEMS BENELUX S.A.
Diagram 169
Update 26/03/2001
Rev 2
General tubing diagram

TRACERlab MX FDG
GEMS BENELUX S.A.
Diagram 169
Update 26/03/2001
Rev 2

Manual de Servicio Sintesizador

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Technical

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL

WARRANTY AND LIABILITY

GEMS Benelux s.a.

78, rue Marie Curie, B-4431 Lige (Loncin)

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL

HEALTH AND SAFETY INFORMATION

2.1 Radiation safety

2.2 Caution relating to caustic substances

2.3 Caution relating to toxic substances

2.4 Caution relating to inflammable substances

2.5 Caution relating to liquid spillage

2.6 Electrical safety

2.7 Temperature hazard

2.8 Mechanical motion safety

2.9 Caution relating to heavy objects

2.10 Accident involving personal injury

2.11 Accident involving fire

2.12 Safety labels

2.13 Hazardous areas inside the TRACERlab MX FDG

SERVICE JOB SAFETY ANALYSIS

CHAPTER 5 : DESCRIPTION OF THE EQUIPMENT

Dimensions of the TRACERlab MX FDG

Weight of the TRACERlab MX FDG

4.1 Connections at the rear

4.2 Connections on the front

Front view of the TRACERlab MX FDG

Rear view, central part of the TRACERlab MX FDG

Left side (as seen from the front)

7.1 Nitrogen supply circuit

7.2 Compressed air supply circuit

Right side view of the TRACERlab MX FDG

Top view of the TRACERlab MX FDG

CHAPTER 6 : MAINTENANCE MODE

Setting of the TRACERlab MX FDG to the maintenance mode

Activation of the rotating valve actuators

Activation of internal valves

Operation of the syringe drivers

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL

5. Operation of the heater

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TRACERlab MX FDG - SERVICE MANUAL

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL

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TRACERlab MX FDG - SERVICE MANUAL

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL

Version III - Last Update : June 2008

TRACERlab MX FDG - SERVICE MANUAL