Cyclomedica TechnegasPlus Technegas 25000 User manual

TechnegasPlus
Technegas™ Generator
USER MANUAL
UM.EU-2.EN
Manufactured in Australia by Cyclomedica Australia Pty Ltd

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1Preamble
The information found in this manual is the latest information at the time of delivery for the
TechnegasPlus Technegas™ Generator, model number 25000.
Cyclomedica Australia Pty Ltd reserves the right to change the content of this manual without prior
notice.
You will be advised of any changes that may affect the use of your TechnegasPlus Technegas™
Generator through your Cyclomedica authorised service partner.
The most recent version of the User Manual can always be found at
http://www.cyclomedica.com/technegasplus-user-manuals/
The TechnegasPlus Technegas™ Generator will meet the specifications described within when it is
installed, operated and maintained in accordance with this manual.
1.1 Manufacturer’s Trademark and Copyright
Technegas™ is a registered Trademark of Cyclomedica Australia Pty. Ltd.
Pulmotec™ is a registered Trademark of Cyclomedica Australia Pty Ltd.
Copyright 2019, Cyclomedica Australia Pty Ltd
All rights reserved.
The contents of this publication may not be reproduced in any form without the written permission
of:
Cyclomedica Australia Pty Ltd
Unit 4, 1 The Crescent
Kingsgrove NSW
AUSTRALIA 2208
Phone: [phone]
Fax: [phone]
Email: [e-mail]

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Table of Contents
1 Preamble..........................................................................................................................................2
1.1 Manufacturer’s Trademark and Copyright ..............................................................................2
2 Product Information ........................................................................................................................6
2.1 Device description ...................................................................................................................6
2.2 Intended use ............................................................................................................................6
2.3 Indications for use ...................................................................................................................6
2.4 Contraindications.....................................................................................................................6
2.5 Maximum exposure .................................................................................................................6
2.6 Principle of operation ..............................................................................................................7
3 Operator responsibility....................................................................................................................9
4 Precautions and safety in use ........................................................................................................10
4.1 Safety in use...........................................................................................................................11
4.2 Radiation safety .....................................................................................................................11
4.3 Moving the TechnegasPlus Technegas™ Generator safely ...................................................11
4.4 Warnings................................................................................................................................11
5 Operating key functions on the TP ................................................................................................13
5.1 Operating the CANCEL Button...............................................................................................13
5.2 Operating the Drawer............................................................................................................13
5.3 Front and Rear panel descriptions.........................................................................................14
6 Installation .....................................................................................................................................15
6.1 Installation information .........................................................................................................15
6.2 Location and storage .............................................................................................................15
6.3 Power supply .........................................................................................................................15
6.4 Argon Gas supply ...................................................................................................................15
6.5 Connecting the argon gas......................................................................................................16
6.6 Battery charging.....................................................................................................................17
6.7 Additional items required......................................................................................................17
6.8 External Transportation.........................................................................................................17
7 Patient Preparation........................................................................................................................18
8 Dosimetry.......................................................................................................................................20
9 Technegas™ ventilation strategies ................................................................................................21
10 Production of Technegas™ prior to administration ......................................................................22
10.1 Safety and Quality check .......................................................................................................22
10.2 Setting up the argon gas supply ............................................................................................22

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10.3 Prepare the TP .......................................................................................................................23
10.4 Open drawer and remove Pulmotec™ (Crucible) fragments ................................................24
10.5 Preparing the Pulmotec™ (Crucible)......................................................................................25
10.6 Simmer Process......................................................................................................................26
10.7 Multiple loadings ...................................................................................................................26
10.8 Burn Process ..........................................................................................................................27
11 Administration of Technegas™......................................................................................................28
12 After administration to the patient ...............................................................................................30
13 Operating the Simmer Plate ..........................................................................................................31
14 Disposal of contaminated items ....................................................................................................33
14.1 List of Contaminated Items....................................................................................................33
14.2 Disposing of used Pulmotec™ (Crucible) ...............................................................................33
14.3 Disposal of Radioactively Contaminated Items.....................................................................33
14.4 Cleaning of radioactive spills .................................................................................................33
15 Maintenance..................................................................................................................................34
15.1 Operator Maintenance ..........................................................................................................34
15.2 Cleaning the TP ......................................................................................................................34
15.3 Changing the Technegas™ Contacts......................................................................................35
15.4 Display Language Selection ...................................................................................................37
15.5 Changing the clock on the TP ................................................................................................37
15.6 Authorised service & maintenance .......................................................................................38
16 Troubleshooting.............................................................................................................................39
16.1 Low activity in inhaled dose...................................................................................................39
16.2 Argon flow monitor ...............................................................................................................39
16.3 Leak test errors ......................................................................................................................39
16.4 Internal case temperature too high ......................................................................................39
16.5 Tripping of the circuit breaker or fuse...................................................................................39
16.6 LCD messages.........................................................................................................................40
16.7 Label descriptions ..................................................................................................................44
17 Specifications .................................................................................................................................46
17.1 General...................................................................................................................................46
17.2 Protection Against Electric Shock..........................................................................................46
17.3 Operating, transport, and storage conditions.......................................................................46
17.4 Consumables..........................................................................................................................47
17.4.1 Argon Gas.......................................................................................................................47
17.4.2 Technegas™ Patient Administration Set (PAS) ..............................................................47

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17.4.3 Technegas™ Contacts ....................................................................................................47
17.4.4 Pulmotec™ (Crucible).....................................................................................................47
17.4.5 Purge filter life ...............................................................................................................47
17.5 Identifying the Date of Manufacture.....................................................................................47
17.6 Electromagnetic Compatibility ..............................................................................................48
18 End of Life decommissioning of the TP..........................................................................................51
19 Further reading ..............................................................................................................................52

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2Product Information
2.1 Device description
The TechnegasPlus Technegas™ Generator (TP) is an electrically powered medical device for creating
hydrophobic Technetium-99m labelled carbon particles1dispersed in air as an aerosol with an
activity median aerodynamic diameter of 200-430nm.2
Technegas™ is the brand name for the system of medical devices and pharmaceuticals used in the
production of the Technetium-99m radio-labelled carbon aerosol also referred to as Technegas™.
The Technegas™ system comprises of the TP, Pulmotec™ (Crucible), the Technegas™ Contacts, the
Technegas™ Patient Administration Set (PAS), and other proprietary components.
The system requires a general purpose 20 A electrical outlet, user supplied Technetium-99m (99mTc)
as sodium pertechnetate (Na TcO4) solution, pure non-denatured ethanol (≥ 95%), and high purity (≥
99.997%) argon gas to create Technegas™.
2.2 Intended use
The nanoparticle size and hydrophobic properties of Technegas™ provide ideal characteristics for
gaseous behaviour and alveolar deposition in the lungs.3This facilitates gamma-ray imaging of the
functional ventilation distribution for diagnosing pathological processes.
Technegas™ is a ventilation agent for ventilation-perfusion imaging studies. In a few breaths and
following gamma camera imaging, Single Photon Emission Computed Tomography SPECT) or
SPECT/CT (Computed Tomography), the technologist/clinician can produce planar or 3D images
providing information on lung function and pulmonary physiology.4
2.3 Indications for use
Technegas™ is safe and effective for use for functional lung ventilation imaging for the assessment of
pulmonary embolism, pulmonary small airway disease including Chronic Obstructive Pulmonary
Disease (COPD), lung resection surgery and other pulmonary ventilatory disorders.
Please refer to Pulmotec™ (Crucible) Product Information Leaflet.
2.4 Contraindications
There are no known contraindications for Technegas™.4
2.5 Maximum exposure
The maximum exposure of the TP to the patient via ventilation through the PAS is 3 minutes in a 24-
hour period.

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2.6 Principle of operation
Figure 1: TechnegasPlus Technegas™ Generator (TP)
The TP is a bespoke high temperature furnace; it is a Class IIb medical device. It uses a combination
of graphite in the form of the Pulmotec™ (Crucible) and an inert atmosphere (argon) to reduce and
then vaporise 99mTc generator eluate in a steel chamber.
It does this by first drying the eluate to remove the water from the saline carrier solution over 6
minutes, during which the chamber is purged of oxygen and filled with argon. The TP then raises the
graphite Pulmotec™ (Crucible) to a temperature of 2750°C ± 100°C within 2 seconds and maintains
this temperature for a period of 15 ± 1 second(s) to produce Technegas™. An optical sensor
maintains the high temperature phase within the specified temperature limits. This validated
process releases greater than 40% of the supplied 99mTc as Technegas™.

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Figure 2: Technegas™ generation and delivery summary
An Operator controlled electrically actuated exit port in the chamber enables the patient to inhale
Technegas™ via the PAS which, by depositing on the surfaces of the alveoli of the lung2, enables the
functioning airways distribution to be mapped by the standard nuclear medicine technology, namely
a gamma camera.3
Prolonged storage of Technegas™ promotes aggregation into larger particles3and the migration of
those particles to the walls of the TP chamber. As such, Technegas™ is intended to be administered
to the patient within 10 minutes of its generation. To prevent accidental use of expired diagnostic
agent, after 10 minutes, the TP inhibits the delivery to the patient and the chamber is automatically
purged through a filter system to trap any residual Technegas™.
To expedite the administration of Technegas™ to the patient, the patient should be prepared during
the Technegas™ generation process.

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3Operator responsibility
Only personnel (Operators) specifically trained on the use of the TP should be allowed to use it.
Operators are responsible for understanding the contents of this manual, including, but not limited
to:
•Measures to ensure their own safety
•The safety of others working in the vicinity of the TP system
•Patient safety
•Using the TP according to the instructions provided in this manual;
•Appropriate operating environment as defined by the specifications in this manual;
•Operator maintenance as per instructions in this manual;
•Facilitating periodic service with Cyclomedica authorised personnel;
•Informing Cyclomedica of complaints, mal-administrations, adverse events;
•Informing Cyclomedica requests for repair should the TP become faulty; and
•Any malfunction which results from the improper use, faulty maintenance, improper repair,
damage, alteration, or modification by anyone other than an authorised Cyclomedica agent.

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4Precautions and safety in use
USE ONLY the Pulmotec™ (Crucible) with the TechnegasPlus Technegas™
Generator (TP).
The Pulmotec™ (Crucible) is the only registered carbon crucible drug product
in Europe with marketing authorisation to be used for the production of
Technegas™. No other carbon crucible has been authorised and validated for
use with the TP.
USE ONLY a solution of Sodium Pertechnetate (Na TcO4) of European or US
Pharmacopoeia grade or equivalent, in the TP.
Only the brass Technegas™ Contacts, manufactured by Cyclomedica Australia, are
validated to be used for the safe and effective performance of the TP and the
production of Technegas™. The Technegas™ Contacts are critical accessories for
the consistent and safe performance of the TP.
The Technegas™ Patient Administration Set (PAS) is a SINGLE USE ONLY
product. Only the Technegas™ Patient Administration Set (PAS),
manufactured by Cyclomedica Australia, is validated to be used for the
safe and effective performance of the TP and the delivery of
Technegas™.
The Pulmotec™ (Crucible) is a SINGLE USE ONLY product.
Unauthorised repairs and replacement of integral componentry will adversely
affect the safe and efficacious operation of the TP; tampering with internal
operating settings is a breach of the Essential Principles of Safety and Performance
of Medical Devices outlined in international Medical Device Regulations.

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4.1 Safety in use
•Handle the Pulmotec™ (Crucible) with care.
•Do not use methylated or denatured alcohol during the Pulmotec™ (Crucible) wetting
process.
•Do not use industrial or welding grade argon with the TP.
•Inspect the Pulmotec™ (Crucible) for visible damage or defects.
•Do not allow repairs to be carried out on the TP by unauthorised personnel; tampering with
a medical device breaches the Essential Principles of Safety and Performance of Medical
Devices outlined in the international Medical Device Regulations.
•Do not insert cleaning brushes or other foreign objects through the various valves, openings
or holes in the TP or its consumables. Damage may result which will make the TP
unserviceable.
•Do not use the TP for any other purpose than that specifically indicated in this manual.
•Do not autoclave the TP or its consumables.
•Good Radiation Practice must be followed as the internal parts of the TP may be
contaminated with ionizing radiation.
•The Patient Delivery Valve must not be opened unless the patient is breathing through the
PAS and the PAS is affixed to the TP.
•Always ensure that the patient continues to breathe through the PAS whilst connected to
the TP with the delivery button released for at least five (5) breaths after the cessation of
Technegas™ inhalation. This clears Technegas™ (the aerosol) from the delivery tubing and
the patient's conducting airways.
•If a patient is unable to use a mouthpiece adequately, Cyclomedica recommends that a face
mask is used with the PAS mouthpiece. Such face masks are available from Cyclomedica.
•Do not leave the TP unattended while it is performing any operation.
4.2 Radiation safety
When used correctly, the TP is fully shielded appropriate for 99mTechnetium up to the recommended
dosimetry and contains self-contained filtration apparatus.
•Disposable gloves must be worn when internal parts of the of the TP are handled.
•The Drawer must be closed when the TP is not in use, to prevent potential release of
radioactive contamination.
•For radiation spills, refer to your radiation safety plan for site’s requirements on spill clean-
up.
4.3 Moving the TechnegasPlus Technegas™ Generator safely
•Inspect the wheels for damage before moving the TP.
•Do not move the TP over uneven or steep surfaces.
•To move the TP, disengage the wheel locks. Be sure to re-engage the wheel locks when the
TP is stationary.
•Do not load the trolley with heavy items such as gas cylinders for transport.
4.4 Warnings
•Argon is an asphyxiation hazard. Always turn OFF the argon supply when not connected to
the TP.

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•The internal components of the TP may be hot.
•Do not open or close the Drawer if you suspect anything may obstruct normal operation.
•The TP weighs approximately 120kg (265lbs), therefore appropriate care should be taken
when moving it.
Dispose of the used consumables as contaminated waste; both will be radioactive
and biologically hazardous after use.
The patient must not touch the TP, only the PAS.

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5Operating key functions on the TP
5.1 Operating the CANCEL Button
The CANCEL button needs to be pressed TWICE within two seconds to activate a "CANCEL"
operation. This eliminates the risk of cancelling an operation accidentally.
Throughout this manual, this operation is referred to as “DOUBLE CANCEL”.
5.2 Operating the Drawer
The Drawer may be opened by pressing the OPEN button when the display reads
" OPEN DRAWER TO "
" CHANGE CRUCIBLE "
To close the drawer from the open position, PRESS and HOLD the Drawer Interlock button at the top
of the TP, then PRESS and HOLD the CLOSE button until the drawer is fully closed and an audible
alert is sounded. The two buttons may then be released.
If either button is released before the Drawer has stopped moving it will
immediately re-open. This ‘two-handed’operation is a safety precaution.
The closing of the Drawer poses a finger and hand trapping hazard.
Issues with opening or closing of the Drawer may pose a radiation hazard if the
TP has recently performed a Burn process. In this event, follow your site’s
radiation safety plan and contact your Cyclomedica authorised service agent.
The Drawer must be closed when the TP is not in use.

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5.3 Front and Rear panel descriptions
Figure 3: Front Panel of the TP
1 –START button
2 –CLOSE button
3 –OPEN button
4 –Display
5 –Socket for Remote delivery button
6 –PAS connection behind metal cover
7 –Patient delivery button
8 –Drawer interlock button
9 –Easy Breather connection
10 –CANCEL button
11 –Amber coloured lead (Pb) shield
12 –TP Drawer
Figure 4: Rear Panel of the TP
1 –Argon inlet connector
2 –Mains switch
3 –Mains power indicator light
1
2
3

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6Installation
6.1 Installation information
The unpacking of the TP from its carton, and the installation for use must be performed by a
Cyclomedica authorised technician.
The Cyclomedica technician will complete the installation checklist to be signed by the Site
Representative.
6.2 Location and storage
Assign an area within the Nuclear Medicine department, preferably near the imaging room, for the
production of Technegas™ and storage of the TP.
The ambient operating conditions for the TP are 10-40°C, 70-106kPa (700-
1060mBar), 15-90% relative humidity non-condensing.
Allow space for the safe storage of used Pulmotec™(Crucibles) and PAS for a minimum of 10 half-
lives before final disposal as non-radioactive waste or as per the regulations or licenses of your local
Competent Authorities.
6.3 Power supply
The Operator must provide an earthed mains power line dedicated for use with
the TP rated at 20 Amps, 200 - 240V ±5%, 50 or 60Hz.
To avoid the risk of electric shock, the TP must only be connected to a supply
mains with protective earth.
6.4 Argon Gas supply
The Operator must provide high purity grade argon (≥99.997%) and the high-
pressure argon regulator to the following specifications:
Maximum outlet pressure
150 kPa
1.48 Atm
21.75 PSI
Maximum flow output
45 L/min
11.88 US gallons/min
95 SCFH

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Figure 5: Set up of argon supply
Secure the argon cylinder as per local regulations.
•Ensure that the ‘high’and ‘low’pressure regulators are turned to the OFF position
prior to setup.
•Ensure that the ‘high’ pressure regulator is firmly connected to the gas supply.
•Ensure that the ‘low’pressure regulator is firmly connected to the high-pressure
regulator.
6.5 Connecting the argon gas
The TP is only designed for use with the supplied argon hose and the Cyclomedica
argon low-pressure regulator.
Figure 6(a, b): Connecting the argon supply hose
To connect the argon hose to the gas argon inlet of the TP, press the black cover, insert the
connector into the socket, and pull the black cover back to engage the locking mechanism.

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6.6 Battery charging
•Plug the TP unit into the 20 Amp electrical power outlet and switch ON using the main
switch located at the rear of the generator.
•The green indicator light above the main switch will illuminate when the TP is powered on.
•Leave the unit plugged in, powered on, and the Drawer closed when not in use to keep the
battery fully charged.
A flat battery will not be evident until you try to deliver Technegas™ to your
patient.
6.7 Additional items required
•One 1mL needleless syringe capable of dispensing 135-300µL
•One 1mL syringe with needle capable of dispensing 135-300µL
•Disposable gloves
•Pure non-denatured ethanol (≥95%)
•A clean non-contaminated flat work surface e.g. a Petri Dish
•Forceps
6.8 External Transportation
•Prior to moving the TP from or between facilities, the TP requires a Cyclomedica authorised
service agent to prepare the TP for safe transport.
•Contact your Cyclomedica authorised service partner or Cyclomedica for
guidance/assistance.

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7Patient Preparation
Figure 7: Supine administration of Technegas™
•For the administration of Technegas™ to the patient, Operators should follow the details in
the Information for Usefor the Technegas™ Patient Administration Set (PAS) and the
Production Information Leaflet for the Pulmotec™ (Crucible).
•Technegas™ should be administered to the patient as soon as possible after being
generated, to enhance the quality of imaging.
•To expedite the administration of Technegas™, the patient should be prepared before or
during the Technegas™ generation process.
•The patient may be prepared supine or upright.
•Patient posture affects the distribution profile of Technegas™ in the lungs in response to the
gravitational effect on blood distribution. Every effort should be made to ventilate the
patient in the same posture as they will adopt for perfusion scanning.
Note: Cyclomedica recommends that patients should be supine (lying down) and the gamma camera
positioned for a posterior view. Body movement and breathing irregularities are reduced if your
patient is in a comfortable but controlled supine position.

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Figure 8: Patient preparation for the delivery of Technegas™
The patient may be prepared in the imaging room or a preparation room as required. A method of
monitoring the inhaled dose during Technegas™ administration is required, for example by using the
gamma camera or a Geiger counter.
1. Select the appropriate mouthpiece or facemask and attach it to the conical connector on the
PAS.
2. Place the mouthpiece in the patient’s mouth ensuring a total seal by their lips. Alternatively,
attach or hold the facemask to the patient, ensuring that the nose and mouth are fully
covered.
3. When using a mouthpiece, place the nose-clip on the patient’s nose.
4. Advise the patient to relax and breathe normally.
5. You may wish to advise the patient to practice breathing with the mouthpiece and nose clip
in place using one of the ventilation strategies detailed in Section 9TECHNEGAS™VENTILATION
STRATEGIES (of this document).
Patients must be instructed not to breathe around the mouthpiece (e.g. not
attempting to talk), as this would lead to low inhaled dose of Technegas™ and
potential room contamination.

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8Dosimetry
Refer to the Pulmotec™ (Crucible) Product Information Leaflet for more information regarding
dosimetry.
•The recommended activity to be loaded in the Pulmotec™ (Crucible) is between 200 - 900
MBq (5.4 mCi –24.3mCi) of 99mTc sodium pertechnetate.
•The recommended radioactive concentration for the Pulmotec™ (Crucible) 135µL is 1480 -
6670 MBq/mL (40 –180 mCi/mL).
•The recommended radioactive concentration for the Pulmotec™ (Crucible) 300µL is 670 -
3000 MBq/mL (18 –81 mCi/mL).
•If a high radioactive concentration eluate is not available, it is possible to carry out multiple
Pulmotec™ (Crucible) loadings as described in section 10.5 PREPARING THE PULMOTEC™
(CRUCIBLE)or using the Pulmotec™ (Crucible) Simmer Plate as described in section 13
OPERATING THE SIMMER PLATE .
•The recommended inhaled dose of Technegas™ is between 20-50MBq (0.5 - 1.3 mCi),or as
directed by the nuclear physician.
The inhaled dose of Technegas™ should be monitored while it is being
administered to the patient.