Important Preparation Information

  * Prepare Technegas Aerosol in the Technegas Plus System ( TP) using the supplied Technegas Crucible. See the User Manual for a comprehensive description of the setup, operation, and maintenance of the TP.
  * Use Sodium Pertechnetate Tc 99m Injection, USP obtained from a commercially available technetium Tc 99m generator.
  * Only use ultra high purity (> 99.997% purity with less than 3 ppm oxygen) argon gas. The presence of oxygen in argon gas during the process of formation of Technegas Aerosol may lead to formation of Pertechnegas Aerosol (instead of Technegas Aerosol), which may affect the image quality. 
  * Wear protective gloves, aprons, and masks for radiation protection and infection control.
  * Handle Technegas Crucibles with forceps. Any oil from the skin will reduce connection efficiency and Technegas yield.
  * Prepare Technegas Aerosol using the TP at 15° to 30oC (59° to 86oF) in a ventilated area that is suitable for using radioactive materials (e.g., Nuclear Medicine Department) near the patient, to enable timely (within 10 minutes) administration [see Dosage and Administration (2.3)].
  * The maximum use period for the TP is one year or 500 burn cycles, whichever occurs first. After this period, ask Cyclomedica to perform maintenance and recertify the TP for use.



Preparation:

  1. Using forceps, remove a Technegas Crucible from its blister pack, inspect the crucible to ensure that it is free of chips or cracks, and place it on a clean flat surface. Store unused crucibles in the original packaging.

( Note: When a blister pack of 10 crucibles is used for the first time, remove the tamper-proof seal to facilitate access to the crucibles. Then carefully remove one crucible (for preparation of each patient’s dose) from the blister pack and reinsert the cardboard backing material to cover all remaining crucibles in their respective individual blister pockets. This prevents ingress of any contaminating material from the immediate environment and allows the crucibles to be securely stored). 

  2. Prepare the Alcohol, USP (i.e.,95%ethanol) wetted crucible. Using a 1mL syringe, fill the crucible reservoir (approximately 0.1 mL) with Alcohol and then draw it back in the syringe.

  3. Open the Technegas Plus System drawer and install the Alcohol wetted crucible between the support electrodes using forceps (see the Technegas Plus System User Manual for details on installation of the Technegas Crucible).

  4. Rotate the crucible to ensure that good electrical contact is made with the support electrodes (Technegas Contacts); ensure the crucible reservoir is upright.

  5. For adult patients, using a 1mL syringe with needle, load 400MBq to 1,000MBq (10.8mCito 27 mCi) of Sodium Pertechnetate Tc99m Injection, USP, in a volume of 0.1 mL while ensuring that the liquid meniscus does not exceed the height of the Crucible (the maximum crucible volume is 0.12 mL, and adding excess volume can lead to radioactive spill in the TP and may lead to formation of aerosol of free pertechnetate Tc 99m that may deteriorate image quality). For the recommended loading activity of Sodium Pertechnetate Tc 99m Injection in pediatric patients aged 6 years and older, refer to Table 1 [see Dosage and Administration (2.2)]. 

  6. Close the drawer and run the SIMMER heating cycle to evaporate the liquid fromthecrucible reservoir. The process continues for 6 minutes, leaving a dry white residue of sodium pertechnetate Tc 99m and sodium chloride in the crucible. During this time the TP chamber is also completely filled with the argon gas (note: 100% argon atmosphere is necessary to prepare pure Technegas Aerosol). When the simmer is complete, the display will read: PRESS [START] TO INITIATE BURN.

  7. Run the BURN heating cycle, during which the crucible containing the dry residue of sodium chloride and pertechnetate Tc 99m is heated to 2,750°C (4,982°F) for 15 seconds in TP, to produce Technegas Aerosol. At the end of BURN cycle, the display will change to “DISCONNECT THE MAINS PLEASE”.

( Note: At this time the argon gas supply is turned OFF and the argon gas line can be disconnected. The main power on the TP can be switched OFF. The TP will remain powered ON from an internal battery for Technegas Aerosol administration to the patient. The TP may be moved to the patient as required.) 

  8. Administer Technegas Aerosol as soon as possible following preparation and completethe inhalation within 10 minutes of its preparation. Do not use after 10 minutes of preparation. [See the TP User Manual for connecting the PAS to the patient and to the TP.]

  9. The crucible is single use only. The TP breaks the crucible at the end of Technegas Aerosol production to prevent re-use. Crucible fragments are radioactive and should be disposed appropriately. Refer to the Technegas Plus System User Manual for detailed information.