Cyclomedica Technegas TechnegasPlus User manual

TechnegasPlus
Technegas® Generator
USER MANUAL
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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.

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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 may breach 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.

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 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.
 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; they will be
both radioactive and biologically hazardous after use.
The patient must not touch the TP, only the PAS.

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5 Operating 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 knob 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 approved service
provider.
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 knob
9 – Easy Breather Valve 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
7
8
9
6
10
11
12
5
4
1
2
3

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6 Installation
6.1 Installation information
The installation for use must be performed by a Cyclomedica approved service provider.
The approved service provider 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.
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%) (Grade
4.7 or greater) 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.
 Only high purity grade (≥ 99.997%) (Grade 4.7 or greater) Argon gas should
be used, not industrial or welding grade Argon.
 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.
CMAPL SUPPLIED
LOW PRESSURE
REGULATOR AND HOSE
USER SUPPLIED
>99.997% ARGON
USER SUPPLIED
HIGH PRESSURE
REGULATOR

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6.6 Battery charging
 Plug the TP Device 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.
 Sodium Pertechnetate Tc99m
6.8 External Transportation
 Prior to moving the TP from or between facilities, Cyclomedica approved service
provider is required to prepare the TP for safe external transport.
 Contact your Cyclomedica approved service provider or Cyclomedica for
guidance/assistance.

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7 Patient Preparation
Figure 7: Supine administration of Technegas®
 For the administration of Technegas® to the patient, Operators should follow the
details in the Information for Use for the Technegas® PAS and the Patient
Information Leaflet for the Pulmotec® (Crucible).
 Technegas® should be administered to the patient as soon as possible and within 10
minutes of Technegas generation.
 To expedite the administration of Technegas®, the patient should be prepared
before or during the Technegas® generation process.
 The patient is prepared in a supine or upright ventilation position.
 The Patient ventilation position affects the distribution profile of Technegas® in the
lungs in response to the gravitational effect on perfusion distribution. Every effort
should be made to perfuse the patient in the same position as the patient was
ventilated.
Figure 8: Upright administration 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. Delivery of Technegas® is
continued until a count rate of approximately 1500 to 2500 counts per second is achieved.

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1. Select the appropriate mouthpiece and attach it to the T- section connector at one
end of the PAS (end closest to filter).
2. Place the mouthpiece in the patient’s mouth ensuring a total seal by the patient’s
lips.
3. Place a nose-clip on the patient’s nose.
4. Advise the patient to relax and maintain normal tidal breathing through the PAS
before it is connected to the TP.
5. When the Technegas® is ready for administration to the patient, using the bayonette
connector, affix the PAS to the TP.

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8 Dosimetry
Refer to the Pulmotec® (Crucible) Patient Information Leaflet for more information
regarding dosimetry.
 The recommended activity to be loaded in the Pulmotec® (Crucible) is between 250
- 700 MBq (7mCi – 19mCi) of 99mTc sodium pertechnetate.
 The recommended radioactive concentration for the Pulmotec® (Crucible) 130µL is
2,500 – 7,000 MBq/mL (70 – 190 mCi/mL).
 The recommended radioactive concentration for the Pulmotec® (Crucible) 300µL is
850 – 2,350 MBq/mL (24 – 64 mCi/mL).
 If a high concentrate eluant 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. Delivery of Technegas® is continued until a
count rate of approximately 1500 to 2500 counts per second is
achieved.