Cyclomedica TechnegasPlus Technegas 25000 User Manual
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Cyclomedica TechnegasPlus Technegas 25000 User Manual

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

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Summary of Contents for Cyclomedica TechnegasPlus Technegas 25000

  • Page 1 TechnegasPlus Technegas™ Generator USER MANUAL UM.EU-2.EN Manufactured in Australia by Cyclomedica Australia Pty Ltd...

  • Page 2: Preamble

    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.

  • Page 3: Table Of Contents

    Table of Contents Preamble ............................2 Manufacturer’s Trademark and Copyright ................2 Product Information ........................6 Device description ........................6 Intended use ..........................6 Indications for use ........................6 Contraindications ........................6 Maximum exposure ......................... 6 Principle of operation ......................7 Operator responsibility ........................
  • Page 4 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 ....................
  • Page 5 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 UM.EU-2.EN TechnegasPlus Technegas™...

  • Page 6: Product Information

    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 particles dispersed in air as an aerosol with an activity median aerodynamic diameter of 200-430nm. 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™.

  • Page 7: Principle Of Operation

    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 Tc generator eluate in a steel chamber.
  • Page 8 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 lung , enables the functioning airways distribution to be mapped by the standard nuclear medicine technology, namely a gamma camera.

  • Page 9: Operator Responsibility

    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. UM.EU-2.EN TechnegasPlus Technegas™ Generator User Manual...

  • Page 10: Precautions And Safety In Use

    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™.

  • Page 11: Safety In Use

    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. •...
  • Page 12 • 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;...

  • Page 13: Operating Key Functions On The Tp

    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.

  • Page 14: Front And Rear Panel Descriptions

    5.3 Front and Rear panel descriptions 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 –...

  • Page 15: Installation

    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™...

  • Page 16: Connecting The Argon Gas

    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.

  • Page 17: Battery Charging

    • 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.

  • Page 18: Patient Preparation

    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.
  • Page 19 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.

  • Page 20: Dosimetry

    8 Dosimetry 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 Tc sodium pertechnetate. •...

  • Page 21: Technegas™ Ventilation Strategies

    9 Technegas™ ventilation strategies There are three preferred ventilation strategies depending on the patient condition, these are summarised below. For more detail, refer to the Pulmotec™ (Crucible) Product Information Leaflet. Operating tip: Encouraging the patient to imitate sucking fluids through a straw can improve the efficiency of the inhalation.

  • Page 22: Production Of Technegas™ Prior To Administration

    10 Production of Technegas™ prior to administration 10.1 Safety and Quality check 1. Wear gloves and use Good Radiation Practice. 2. Inspect the Pulmotec™ (Crucible) for visible damage or defects. 3. Visually check that the ethanol used for wetting the Pulmotec™ (Crucible) is ≥ 95% pure and non-denatured.

  • Page 23: Prepare The Tp

    TP. 3. If necessary, switch ON the TP. The display will show the name Cyclomedica Australia Pty Ltd, the current TP software version and the date and time. If a ‘purge’ has not been carried out since the last Technegas™ (aerosol) generation, the TP will then check if the Drawer is closed and perform a purge operation The purge (through an internal filter) is to ensure that no residual Technegas™...

  • Page 24: Open Drawer And Remove Pulmotec™ (Crucible) Fragments

    10.4 Open drawer and remove Pulmotec™ (Crucible) fragments During Technegas™ generation all internal components of the chamber and gas pathway leaving the chamber are radioactively contaminated. Use Good Radiation Practices including wearing disposable gloves. The internal components of the TP may be HOT! 1.

  • Page 25: Preparing The Pulmotec™ (Crucible)

    10.5 Preparing the Pulmotec™ (Crucible) Figure 11 (a, b): Installing the Pulmotec™ (Crucible) into the TP Drawer 1. Using the forceps, pick up the Pulmotec™ (Crucible) from its packaging and place it on a non- contaminated flat surface. 2. To wet the Pulmotec™ (Crucible), use a 1mL syringe and fill the Pulmotec™ (Crucible) with 95% pure non-denatured ethanol, then draw the ethanol back into the syringe.

  • Page 26: Simmer Process

    USE ONLY a solution of sodium pertechnetate ( Tc) of European or US Pharmacopoeia grade or equivalent in the TP For further dosimetry information, refer to the Pulmotec™ (Crucible) Product Information Leaflet. 10. To close the Drawer, PRESS and HOLD the DRAWER INTERLOCK button, then PRESS and HOLD the ‘CLOSE’...

  • Page 27: Burn Process

    10.8 Burn Process 1. Press the START button to initiate the Burn process. 2. When the burn is complete the display will read: VERIFYING BURN 3. The display will then change to: DISCONNECT THE MAINS PLEASE Technegas™ is now prepared and ready for inhalation by the patient within 10 minutes.

  • Page 28: Administration Of Technegas

    11 Administration of Technegas™ Use disposable gloves and conduct Good Radiation Practice. Do not press the Patient Delivery Button or Remote Delivery Button until the patient is being ventilated through the TP as Technegas™ will be released. The inhaled dose for an adult is usually about 20-50MBq (0.54-1.35mCi). Refer to the Pulmotec™...
  • Page 29 1. Attach the PAS to the TP by pushing the end of the hose into the PAS connection on the TP and rotating clockwise. 2. Press the START button. The display will read: " PRESS [CANCEL] " " IF FINISHED "...

  • Page 30: After Administration To The Patient

    If the TP does not perform the automated Purge process after the Burn process, contact your Cyclomedica authorised service agent. Do not leave the TP unattended while the argon supply is turned ON. Ensure the Drawer is left closed and the argon supply is OFF when the TP is not in use.

  • Page 31: Operating The Simmer Plate

    13 Operating the Simmer Plate Figure 14: Simmer Plate set up • The Drawer contains a Simmer Plate that allows simultaneous preparation of up to five Pulmotec™ (Crucibles) with multiple loadings of Tc sodium pertechnetate. • The Simmer Plate is useful for sites performing multiple Technegas™ operations in a single day or institutions that do not have access to high activity Tc sodium pertechnetate.
  • Page 32 6. Close the Simmer Plate lid using the forceps. When ready to perform the production of Technegas™, carefully place the Pulmotec™ (Crucible) in the Technegas™ Contacts, using the forceps and continue to follow instructions, as detailed above in section 10 P ™...

  • Page 33: Disposal Of Contaminated Items

    The disposal of radioactive and infectious waste is subject to the regulations and the appropriate licenses of the local Competent Authority or Regulatory Body. If advice on disposal is required, Cyclomedica recommends that Operators contact their local Competent Authority or Regulatory Body.

  • Page 34: Maintenance

    15 Maintenance The TP must not be serviced or maintained while in use with a Patient. 15.1 Operator Maintenance The Operator must: • Replace the Technegas™ Contacts every 50 burns as described in 15.3 C HANGING THE ™ C ECHNEGAS ONTACTS •...

  • Page 35: Changing The Technegas™ Contacts

    15.3 Changing the Brass Technegas™ Contacts • The TP automatically counts down the remaining Burns for each new set of Technegas™ Contacts installed. • The Technegas™ Contacts must be replaced every 50 Burns to ensure the safe and efficacious production of Technegas™. •...
  • Page 36 Do not over-tighten the screws as excessive force may damage the screw thread inside the brass pedestal. 8. Switch ON the TP and the following message will be displayed: "CONTACTS [OPEN ] = NO " "CHANGED ?? [CLOSE] = YES" 9.

  • Page 37: Display Language Selection

    15.4 Display Language Selection The user interface language of the TP may be selected at installation or during a general service by the authorised service agent. The default language of the TP is English. The other available languages are: • French •...

  • Page 38: Authorised Service & Maintenance

    There are no User modifiable or serviceable parts other than those described in 15.1 O PERATOR AINTENANCE • Only a Cyclomedica authorised service agent is authorised to carry out a general service of the TP. • Only a Cyclomedica authorised service agent is authorised to replace the internal battery. •...

  • Page 39: Troubleshooting

    If the patient has a low inhaled dose or low activity count per minute when imaged, this may be due to the TP producing a low yield of Technegas™. Contact your Cyclomedica authorised service partner to identify and resolve any issues related to the operation of the TP.

  • Page 40: Lcd Messages

    16.6 LCD messages LCD MESSAGE Meaning and Actions required The TP is purging (cleaning) the chamber prior to allowing the WAIT PURGING CHAMBER Drawer to be opened. The Drawer is ready to be opened to load a Pulmotec™ OPEN DRAWER TO (Crucible).
  • Page 41 LCD MESSAGE Meaning and Actions required Indicates to the Operator to press the START button to unlock [START] RELEASES THE the Patient Delivery Valve. GAS VALVE If the CLOSE button is pressed without first pressing the PRESS DRAWER DRAWER INTERLOCK button this message will be displayed INTERLOCK KNOB along with an audible alert.
  • Page 42 LCD MESSAGE Meaning and Actions required Indicates that there may be an issue with the Drawer. Try THE DRAWER FAILED TO closing and opening the Drawer again. If this fails to fix the CLOSE IN THE TIME issue, then contact your authorised service agent for ALLOWED assistance.
  • Page 43 LCD MESSAGE Meaning and Actions required Indicates that the Operator needs to press the CANCEL button. PRESS CANCEL TO Press the CANCEL button twice within two seconds to cancel an RESTART operation and restart the TP. Indicates that no pressure was detected in the TP chamber. CHAMBER OPEN OR NO This may mean that the argon is either not connected or not ARGON GAS...

  • Page 44: Label Descriptions

    16.7 Label descriptions REFER TO INSTRUCTION MANUAL/BOOKLET CONSULT INSTRUCTIONS FOR USE OFF (POWER DISCONNECTION FROM THE MAINS) International Symbol for power OFF. ON (POWER CONNECTION TO THE MAINS) International Symbol for power ON SEALED LEAD ACID RECHARGEABLE BATTERY RATING 12V, 1.2AH This label is located on the chassis adjacent to the battery.
  • Page 45 DEPRESS PATIENT DELIVERY BUTTON TO A POSITIVE STOP This label is located on the TP top cover next to the PATIENT DELIVERY BUTTON. ROTATE HOSE TO CONNECT This label is located on the front of the TP Cover surrounding the Delivery Nozzle. It shows the direction of turn when connecting the Patient Administration Set to the TP.

  • Page 46: Specifications

    17 Specifications Further information may be found in the Cyclomedica TechnegasPlus Technegas™ Generator Service Manual. 17.1 General Supply Voltage 200-240 VAC +/- 5% Transformer tapping set at installation. Supply Frequency 50-60 Hz Mains Current – Steady State < 0.2 A RMS Mains Current - Maximum –...

  • Page 47: Consumables

    The lifetime is 3000 operational cycles. The Purge filter is replaced periodically as required during the service of the TP. The Purge Filter is not accessible by the Operator and must only be replaced by a Cyclomedica approved service provider. 17.5 Identifying the Date of Manufacture The Serial Number for a TP is found on the Rear Panel of the device.

  • Page 48: Electromagnetic Compatibility

    17.6 Electromagnetic Compatibility Guidance and manufacturer’s declaration – electromagnetic emissions The TP is intended for use in the electromagnetic environment specified below. The User of the TP should assure that it is used in such an environment. Emissions Tests Compliance Electromagnetic Environment - Guidance The TP uses RF energy only for its internal function.
  • Page 49 Guidance and manufacturer’s declaration – electromagnetic immunity The TP is intended for use in the electromagnetic environment specified below. The User of the TP should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic environment - Test level guidance...
  • Page 50 Recommended separation distances between portable and mobile RF communications equipment and the TP The TP is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the TP can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the TP as recommended below, according to the maximum output power of the communications equipment.

  • Page 51: End Of Life Decommissioning Of The Tp

    • The TP has a recommended use life of 10 years from date of manufacture. • You must contact your local distributor or Cyclomedica for assistance with the decommissioning of the TP. • Decommissioning of the TP may be subject to local regulations for medical devices.

  • Page 52: Further Reading

    Eur J Nucl Med (1993); 20(7): 576-579 2. Irshad H, Kuehl P (Lovelace Biomedical). Aerosol Characterization of TechnegasPlus Generator. (2017). Internal Cyclomedica Australia Pty Ltd document; unpublished - commercial in confidence 3. Bajc M, Schümichen C, Grüning T, et al. EANM guideline for ventilation/perfusion single- photon emission computed tomography (SPECT) for diagnosis of pulmonary embolism and beyond.

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