Cyclomedica Technegas TechnegasPlus User manual

TechnegasPlus
Technegas® Generator
USER MANUAL
MNL-0007 Rev 07 EU-EN
ENGLISH
Manufactured in Australia by Cyclomedica Australia Pty Ltd

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1 Preamble
The information found in this manual is the latest information at the time of delivery for the
TechnegasPlus Technegas® Generator (TP).
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 approved service provider.
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 2022, Cyclomedica Australia Pty Ltd
All rights reserved.
The contents of this publication may not be reproduced in any form without the written
permission of:
Manufacturer Authorised Representative
Cyclomedica Australia Pty Ltd
Unit 4, 1 The Crescent
Kingsgrove
NSW 2208
AUSTRALIA
Phone: [phone]
Email: [e-mail]
Cyclomedica Europe Ltd
Unit A5, Calmount Business Park
Ballymount
Dublin 12
IRELAND
Phone: [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 .................................................................................................... 7
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 .................................................................................................................. 12
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 technique .................................................................................. 21
10 Production of Technegas® prior to administration ......................................................... 22
10.1 Safety and Quality check ......................................................................................... 22

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10.2 Setting up the Argon gas supply .............................................................................. 23
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 ................................................................................. 29
13 Operating the Simmer Plate ............................................................................................ 30
14 Disposal of contaminated items ..................................................................................... 32
14.1 List of Contaminated Items ..................................................................................... 32
14.2 Disposing of used Pulmotec® (Crucible) .................................................................. 32
14.3 Disposal of Radioactively Contaminated Items ...................................................... 32
14.4 Cleaning of radioactive spills ................................................................................... 32
15 Maintenance .................................................................................................................... 33
15.1 Operator Maintenance ............................................................................................. 33
15.2 Cleaning the TP ........................................................................................................ 33
15.3 Changing the Brass Technegas® Contacts .............................................................. 34
15.4 Display Language Selection ..................................................................................... 36
15.5 Changing the clock on the TP .................................................................................. 36
15.6 Authorised service & maintenance ......................................................................... 37
16 Troubleshooting .............................................................................................................. 38
16.1 Troubleshooting Table ............................................................................................. 38
16.2 LCD messages .......................................................................................................... 41
16.3 Label and Symbols ................................................................................................... 46
17 Specifications .................................................................................................................. 47
17.1 General ..................................................................................................................... 47
17.2 Protection Against Electric Shock ........................................................................... 47
17.3 Operating, transport, and storage conditions ......................................................... 47
17.4 Consumables ........................................................................................................... 48
17.4.1 Argon Gas .......................................................................................................... 48
17.4.2 Technegas® PAS ............................................................................................... 48
17.4.3 Technegas® Contacts........................................................................................ 48

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17.4.4 Pulmotec® (Crucible) ........................................................................................ 48
17.4.5 Purge filter life .................................................................................................. 48
17.5 Identifying the Date of Manufacture ....................................................................... 48
17.6 Electromagnetic Compatibility ................................................................................ 49
18 End of Life decommissioning of the TP ........................................................................... 52
19 Further reading ................................................................................................................ 53

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2 Product Information
2.1 Device description
The TechnegasPlus Technegas® Generator (TP) is an electrically powered medical device
for creating hydrophobic Technetium-99m labelled Carbon particles1 dispersed in Argon as
an aerosol.
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 the TechnegasPlus Technegas® Generator (TP),
Pulmotec® (Crucible), the Technegas® Contacts (Contacts), the Technegas® Patient
Administration Set (PAS), and other proprietary components.
These instructions for use are designed to be read in conjunction with the PAS and Contacts
Technegas® Kit Instructions for Use.
The system requires a general purpose 20 A electrical outlet, user supplied Technetium-
99m (99mTc) as sodium pertechnetate (NaTcO4) solution, pure non-denatured ethanol (≥
95%), and high purity (≥ 99.997%) (Grade 4.7 or greater) Argon gas to create Technegas®.
2.2 Intended use
The Technegas® System is for use for functional lung ventilation imaging for the
assessment and treatment efficacy monitoring of pulmonary embolism, pulmonary small
airway disease including Chronic Obstructive Pulmonary Disease (COPD), lung resection
surgery, and other pulmonary ventilatory disorders.
The nanoparticle size and hydrophobic properties of Technegas® provide ideal
characteristics for gaseous behaviour and alveolar deposition in the lungs.2 This facilitates
gamma-ray imaging of the functional ventilation distribution for diagnosing pathological
processes.
Technegas is administered 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.3
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 the Pulmotec® (Crucible) Patient Information Leaflet and the Instructions for
Use for the Technegas Contacts and PAS, respectively.
2.4 Contraindications
There are no known contraindications for Technegas®.3

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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.
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 sodium pertechnetate in a steel chamber.
It does this by first simmering the eluate to evaporate all 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.

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Figure 2: Technegas® generation and delivery summary
An Operator-controlled electrically operated valve in the chamber enables the patient to
inhale Technegas® via the PAS which, by depositing on the surfaces of the alveoli of the
lung, enables the functioning airways distribution to be mapped by the standard nuclear
medicine technology, namely a gamma camera.2
Prolonged storage of Technegas® promotes aggregation into larger particles3 and 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. Once the device is reconnected to power and Argon, the TP will perform an
automated 3-minute cycle to purge and trap residual Technegas® within the chamber
through a filter system.
To expedite the administration of Technegas® to the patient, the patient should be
prepared during the Technegas® generation process.

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3 Operator 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, maintenance or service
issues, improper repair, damage, alteration or modification by anyone other than a
Cyclomedica approved service provider.
 Any serious incident that occurs in relation to this device must be reported to the
manufacturer and the competent authority of the member state in which the
incident occurred.

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4 Precautions 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 (NaTcO4) 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 may
adversely affect the safe and efficacious operation of the TP; tampering with
internal operating settings may be a breach of the Essential Principles of
Safety and Performance of Medical Devices outlined in International Medical
Device Regulations.
The TP is a non-sterile medical device.