Subscribe to Our Youtube Channel
Related Manuals for Cyclomedica Technegas Plus System 25000
Summary of Contents for Cyclomedica Technegas Plus System 25000
- Page 1 Technegas® Plus System USER MANUAL MNL-0009 Rev 10 US-EN Manufactured in Australia by Cyclomedica Australia Pty Ltd...
-
Page 2: Preamble
1 Preamble The information in this manual is for the Technegas® Plus System, 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 Technegas Plus System through your Cyclomedica authorized service partner. -
Page 3: Table Of Contents
Table of Contents Preamble ..........................2 Manufacturer’s Trademark and Copyright ..............2 Table of Symbols and Abbreviations ................. 6 Product Information ......................8 Description ........................8 Indications ........................8 Contraindications ......................8 Biocompatibility evaluation of breathing gas pathways ..........9 Principle of operation .................... - Page 4 Setting up the argon gas supply ................23 Prepare the TP for use ..................... 24 Open drawer and remove Technegas Crucible fragments ........25 Preparing the Technegas Crucible ................26 Simmer process ....................... 28 Burn process ......................29 10 Administration of Technegas Aerosol ................30 10.1 Administration information ..................
- Page 5 15.2 Protection against electric shock ................48 15.3 Operating, transport, and storage conditions ............48 15.4 Consumables ......................49 15.4.1 Argon gas ......................49 15.4.2 Technegas Patient Administration Set (PAS) ........... 49 15.4.3 Technegas Contacts (electrodes) ..............49 15.4.4 Technegas Crucible ..................49 15.4.5 Purge filter life ....................
-
Page 6: Table Of Symbols And Abbreviations
2 Table of Symbols and Abbreviations Symbol Description WARNING HOT SURFACE WARNING RADIATION WARNING HIGH VOLTAGE WARNING BIOHAZARD SINGLE USE ONY 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... - Page 7 Symbol Description DEPRESS PATIENT DELIVERY BUTTON TO A POSITIVE STOP This label is located on the TP top cover next to the PATIENT DELIVERY BUTTON. This label is located on the Low-Pressure argon Gas Regulator. It specifies that only ARGON gas be used with the TP. TYPE B APPLIED PART Technegas Plus System (also commonly referred to as TechnegasPlus Technegas...
-
Page 8: Product Information
3 Product Information 3.1 Description Figure 1: Technegas Plus System (TP) The Technegas Plus System (TP) is an automated module to prepare and administer Technegas Aerosol (technetium Tc 99m-labeled carbon inhalation aerosol) in argon gas from the supplied Technegas Crucible (kit for the preparation of technetium Tc 99m labeled-carbon inhalation aerosol) and the user supplied sodium pertechnetate Tc 99m injection, USP. -
Page 9: Biocompatibility Evaluation Of Breathing Gas Pathways
3.4 Biocompatibility evaluation of breathing gas pathways According to ISO 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications, a typical exposure of a patient over a period of 3 minutes during the use of the TP has not been shown to result in any significant exposure to Volatile Organic Compounds;... -
Page 10: Administering The Technegas Aerosol To The Patient
Figure 2: Technegas Aerosol generation and delivery summary 3.5.2 Administering the Technegas Aerosol to the patient An operator controlled electrically actuated exit port in the chamber enables the patient to inhale Technegas Aerosol directly from the chamber via the PAS. Technegas Aerosol expires 10 minutes after it is prepared. -
Page 11: Operator Responsibility
Reporting any serious incident that occurs in relation to the TP to the manufacturer and their US Authorized Representative identified on page 2 Reporting SUSPECTED ADVERSE REACTIONS to Cyclomedica Australia Pty Ltd at 1- 888-586-4396 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch MNL-0009 Rev 10 US-EN... -
Page 12: Precautions And Safety In Use
Only use Sodium Pertechnetate Tc 99m Injection, USP in the TP. Only use the brass Technegas Contacts (electrodes), manufactured by Cyclomedica Australia. The Technegas Contacts are critical accessories for the safe and effective performance of the TP. The Technegas Patient Administration Set (PAS) is a SINGLE USE ONLY product. -
Page 13: Radiation Safety
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. Resulting damage may render the TP unusable and unserviceable. ... -
Page 14: Moving The Technegas Plus System Safely
5.3 Moving the Technegas Plus System safely The TP weighs approximately 120 kg (265 lb), therefore appropriate care should be taken when moving it. To move the TP, disconnect it from the argon gas cylinder and disengage the wheel locks. -
Page 15: Operating Key Functions On The Tp
6 Operating Key Functions on the TP 6.1 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 –... -
Page 16: Operating The Cancel Button
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 authorized service partner. Keep the Drawer closed when the TP is not in use. -
Page 17: Installation And Operation Requirements
7 Installation and Operation Requirements 7.1 Installation information The authorized Cyclomedica representative will unpack and install the TP. User should not install the TP. The Cyclomedica authorized representative will complete the installation checklist to be signed by the user representative. - Page 18 The TP is designed for use with the supplied argon hose and the Cyclomedica argon low-pressure regulator. Figure 5: Set up of argon supply Secure the argon cylinder as per local regulations. Only ultra-high purity grade (≥ 99.997% purity with less than 3 ppm oxygen) ...
-
Page 19: Oxygen Sensor
preventative maintenance, whichever is earlier. 7.7 External transportation Prior to moving the TP from or between facilities, contact Cyclomedica to prepare the TP for safe transport and subsequent optimal operation. MNL-0009 Rev 10 US-EN 12 Oct 2023 Technegas Plus System User Manual... -
Page 20: Patient Preparation
8 Patient Preparation Prepare the patient for Technegas Aerosol administration in the imaging room or preparation room before starting preparation of Technegas Aerosol. Figure 7: Patient preparation for the delivery of Technegas Aerosol 1. Prepare the patient in supine position. 2. -
Page 21: Preparation Of Technegas Aerosol
9 Preparation of Technegas Aerosol 9.1 Safety and quality check 1. Wear gloves and exercise good radiation protection practice (ALARA principles). 2. Inspect the Technegas Crucible for visible damage. 3. Ensure that correct components (materials) (e.g., Alcohol, USP) are being used. 4. -
Page 22: Required Items
The installation and use of an oxygen sensor in the room where the argon gas cylinder is located that alarms if the oxygen level falls below a safe level is strongly recommended. 9.2 Required items To prepare and administer Technegas Aerosol using the TP, Cyclomedica provides the following items: Technegas Crucible ... -
Page 23: Setting Up The Argon Gas Supply
3. Adjust the argon supply on the high-pressure regulator and set the flow rate to approximately 15 liters per minute. 4. The Cyclomedica supplied low-pressure regulator is fit-for-use and does not require adjustment. 5. Observe the argon high pressure regulator and check that the argon cylinder has positive pressure once cylinder valve is opened for preparing Technegas Aerosol. -
Page 24: Prepare The Tp For Use
TP. 3. If necessary, switch ON the TP. The display will show the name Cyclomedica Australia Pty Ltd and the current TP software version along with the date and time. If a ‘Purge’ has not been carried out since the last Technegas Aerosol preparation, the TP will then check if the Drawer is closed and perform a Purge operation. -
Page 25: Open Drawer And Remove Technegas Crucible Fragments
9.5 Open drawer and remove Technegas Crucible fragments During and after Technegas Aerosol preparation, all internal components of the chamber and gas pathway leaving the chamber are radioactively contaminated. Use Good Radiation Protection Practices including wearing disposable gloves. The internal components of the TP may be HOT! 1. -
Page 26: Preparing The Technegas Crucible
9.6 Preparing the Technegas Crucible Figure 11: Installing the Technegas Crucible into the TP Drawer 1. Using the forceps, pick up the Technegas Crucible from its packaging and place it on a clean flat surface. 2. To wet the Technegas Crucible, use a 1 mL syringe and fill the Technegas Crucible with Alcohol, USP (95% ethanol), then draw the ethanol back into the syringe. - Page 27 Figure 12: Loading Sodium Pertechnetate Tc 99m Injection, USP into the Technegas Crucible 11. For adult patients, using a new 1 mL syringe with needle, load the Technegas Crucible with 400 MBq to 1,000 MBq (10.8 mCi to 27 mCi) sodium pertechnetate Tc 99m injection in a volume of approximately 0.1 mL, while ensuring that the liquid meniscus does not exceed the height of the crucible.
-
Page 28: Simmer Process
Only USE Sodium Pertechnetate Tc 99m Injection, USP in the TP Refer to the TECHNEGAS Prescribing Information for complete dosing and administration instruction. 12. To close the Drawer, PRESS and HOLD the DRAWER INTERLOCK button, then PRESS and HOLD the ‘CLOSE’ button. Keep both buttons depressed until the Drawer is fully closed. -
Page 29: Burn Process
9.8 Burn process 1. Press the START button to initiate the Burn process, which heats the crucible to 2,750°C (4,982°F) for 15 seconds to produce the aerosol. 2. When the Burn is complete the display will read: VERIFYING BURN 3. The display will then change to: DISCONNECT THE MAINS PLEASE Technegas Aerosol is now prepared and ready for inhalation by the patient within 10 minutes. -
Page 30: Administration Of Technegas Aerosol
10 Administration of Technegas Aerosol Use disposable gloves and conduct Good Radiation Protection Practice. Do not press the Patient Delivery Button or Remote Delivery Button until the patient is being ventilated through the TP, as Radioactive Technegas Aerosol will be released. The activity present in the lungs after each inhalation varies. -
Page 31: Administration Information
10.1 Administration information For complete dosing and administration instructions see the TECHNEGAS Prescribing Information and Section 10.2 “Recommended breathing methods for Technegas Aerosol inhalation”. Technegas Aerosol should be administered as soon as possible after being prepared and the administration must be finished within 10 minutes of its preparation. ... -
Page 32: Tp Operation During Administration
10.3 TP operation during administration Figure 14: Supine administration of Technegas Aerosol 1. After placing the PAS mouthpiece and nose-clip on patient (see Section 8 “Patient Preparation”), attach the other end of the PAS to the TP by pushing the end of the hose into the PAS connection on the TP and rotating clockwise. - Page 33 12. Place the PAS into the PAS sleeve (as shown in Figure 15 below) and dispose in accordance with local and regulatory guidelines for biological and radioactive waste. Figure 15: Disposal of the PAS MNL-0009 Rev 10 US-EN 12 Oct 2023 Technegas Plus System User Manual 33 of 53...
-
Page 34: After Administration To The Patient
If the TP does not perform the automated Purge process after the Burn process, contact your Cyclomedica authorized service. Do not leave the TP unattended while the argon supply is turned ON. Ensure the Drawer is closed and the argon supply is OFF when the TP is not in use. - Page 35 An oxygen sensor should be installed in the room where the argon gas cylinder is located. The sensor should alarm if the oxygen level falls below a safe level. If an independent oxygen sensor is not installed, the facility must be designed with controls to comply with OH&S requirements for using and storing compressed gases.
-
Page 36: Disposal Of Contaminated Items
12.3 Disposal of radioactively contaminated items Dispose of radioactive and infectious waste according to applicable national, state, and local regulations. If advice on disposal is required, Cyclomedica recommends that Operators contact their local Competent Authority or Regulatory Body. 12.4 Cleaning of radioactive spills If a radioactive spill occurs within the lower chamber, it may be left to decay as it is in a shielded environment before cleaning (surface wipe only with damp lint free wipe). -
Page 37: Maintenance
13 Maintenance The TP must not be serviced or maintained while in use with a patient. 13.1 Operator maintenance The Operator must: Replace the Technegas Contacts every 50 burns as described in Section 13.3 “ Changing the Technegas Contacts”. Empty the Ash tray of Technegas Crucible fragments prior to preparation of ... -
Page 38: Changing The Technegas Contacts
13.3 Changing the Technegas Contacts The Technegas Contacts must be replaced every 50 Burns to ensure the safe and effective preparation of Technegas Aerosol. The TP automatically counts down the Burns remaining for each new set of Technegas Contacts installed. ... -
Page 39: Display Language Selection
Figure 17: Technegas Contacts 13.4 Display language selection The user interface language of the TP may be selected at installation or during a general service by the Cyclomedica authorized service partner. The default language of the TP is English. MNL-0009 Rev 10 US-EN... -
Page 40: Changing The Clock On The Tp
13.5 Changing the clock on the TP LCD MESSAGE Meaning and actions required ROUTINES Indicates that the Clock Setting Routine has begun. THE CLOCK HAS NOT YET BEEN The TP detects that the clock has not been set and requests the operator to follow the clock setting routine. -
Page 41: Authorized Service And Maintenance
TP and recertify the TP. If a fault arises in the operation of the TP, switch it OFF and contact a Cyclomedica representative for service. Do not operate the TP until the fault is resolved. -
Page 42: Troubleshooting
14.1 Dead battery during administration period If the battery dies during the administration period the release button will not function to open the patient valve. The user should contact a Cyclomedica authorized service partner to resolve the issue. 14.2 Accidental double cancel during administration period If the user accidentally presses the double cancel during administration the TP will cancel its operation and shut down. -
Page 43: Tripping Of The Circuit Breaker Or Fuse
Drawer and lower chamber. Where possible, re-set the circuit breaker or replace the fuse. If the unit trips again, contact your Cyclomedica authorized service partner. MNL-0009 Rev 10 US-EN 12 Oct 2023... -
Page 44: Lcd Messages
14.8 LCD messages LCD MESSAGE Meaning and Actions required The TP is purging (cleaning) the chamber prior to allowing WAIT PURGING CHAMBER the Drawer to be opened. The Drawer is ready to be opened to load a Technegas OPEN DRAWER TO Crucible. - Page 45 LCD MESSAGE Meaning and Actions required Indicates to the Operator to press the START button to [START] RELEASES THE unlock 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 INTERLOCK KNOB displayed along with an audible alert.
- Page 46 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 OPEN IN THE TIME the issue, then contact your authorized service partner ALLOWED for assistance.
- Page 47 Indicates that a failure has occurred in controlling the TRIAC FAILURE Technegas Crucible temperature. Contact your Cyclomedica authorized service partner for assistance. Indicates that the TP has detected a failure and requires TURN OFF AND TRY the power to be switched OFF and then back ON again to AGAIN reset the TP.
-
Page 48: Specifications
15 Specifications Further information may be found in the Cyclomedica Technegas Plus System Service Manual. 15.1 General Supply Voltage 200 VAC to 240 VAC +/- 5% Transformer tapping set at installation. Supply Frequency 50 Hz to 60 Hz Mains Current –... -
Page 49: Consumables
Purge processes. The filter’s lifetime is 3,000 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 authorized service partner as part of the preventative maintenance schedule. -
Page 50: Electromagnetic Compatibility
15.6 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 RF Emissions... - Page 51 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 Test level environment - guidance...
- Page 52 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 53: End Of Life Decommissioning Of The Tp
required annual maintenance, which will recertify the TP for optimal performance. 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.
Need help?
Do you have a question about the Technegas Plus System 25000 and is the answer not in the manual?
Questions and answers