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.