TechnegasPlus
Contents
1. Technegas Generator USER MANUAL MEDICAL Technegas Generator USER MANUAL ured in Australia by Vita Medical Limited 25862 English Version Revision A NOTICES Attention The information found in this manual is the latest information at the time of delivery However Vita reserves the right to change specifications and recom mended procedures without prior notice Should this occur and affect the use of your TechnegasPlus Generator you will be advised of any upgrades or recommended procedural changes which will be accompanied by amendment sheets for this manual Copyright Copyright 2005 Vita Medical Limited All rights reserved Design by Status Ad Group Australia The contents of this publication may not be reproduced in any form without the written permission Vita Medical Limited Building No 75 Business amp Technology Park New Illawarra Road LUCAS HEIGHTS NSW 2234 AUSTRALIA Phone 61 2 9541 0411 Facsimile 61 2 9543 0960 email sales vitamedical com au CONTENTS Section Title Page No INTRODUCTION 9 What is Technegas How does the TechnegasPlus Technegas Generator Work USER RESPONSIBILITY 10 Precautions and Warnings SAFETY IN USE 11 Safe Handling of Compressed Gas Cylinders Use of Gloves Traceability Safe Patient Delivery of Technegas Moving the TechnegasPlus Generator Safely OPE2. The Crucible Oven operates independently from the Technegas Generator and begins its own simmer cycle each time the Drawer is closed At the same time the Technegas Generator may continue to be used to prepare Technegas by following the normal process PRECAUTIONS e The Crucible Oven should ONLY be operated by trained Radiation Workers to avoid risks involving radiation spills unnecessary radiation exposure or contamination OPERATION BY TRAINED RADIATION WORKERS ONLY OBSERVE RADIATION HAZARD PRECAUTIONS AT ALL TIMES e The Crucible Oven contains components heated to a high temperature Use precaution when handling eg DO NOT place crucibles in the Crucible Oven by hand always use for ceps when handling crucibles USE ONLY Solution of Sodium Pertechnetate 99 of European Pharmacopoeia grade or equivalent in the Technegas Generator OPERATION Caution Hot surface present Do not touch the hot surface SSS as it may result in a burn injury To pre load a crucible with activity using the Crucible Oven open the Technegas Generator Drawer and fit the wetted crucible s into position on the Crucible Oven Heating Plate using forceps Load the crucible s with technetium eluate and close the Drawer Fill crucibles ONLY with Sodium Pertechnetate Tc99m DO NOT OVERFILL flat or concave meniscus is recommended Simmering by the Crucible Oven will begin Up to 5 crucibles may be placed on the Crucible Oven Heating Plate
3. Note that the Drawer may only be opened to refill the crucible s being prepared during the Technegas cycle when prompted by the display OPEN DRAWER TO CHANGE CRUCIBLE or by pressing the CANCEL key TWICE during the normal Technegas simmer cycle Refill the Crucibles and Close the Drawer to start a new Crucible Oven simmer Any crucibles that are unused after pre loading on one day may be continued to be pre loaded on subsequent days until burnt If it is necessary to double dose a crucible already fitted between the Contacts after loading then press the CANCEL button TWICE within two seconds at the end of the simmer vita medical technegasplus generator manual 26 DISPOSAL OF CONTAMINATED ITEMS cycle This will allow the drawer to be opened again There is no need to re wet the crucible with alcohol List of Contaminated Items The crucible The USED Patient Administration Set PAS Crucible contacts Gloves NOTE The crucible and the Patient Administration Set are single use items and should be handled as follows Always use disposable gloves during handling contaminated items The crucible is broken automatically following Technegas generation to prevent accidental re use which would result in erratic yields The debris is collected in a tray beneath the con tacts and will contain a residue of radioactivity It should be treated as low level radioactive waste The PAS and mouthpieces should be treated sim
4. electromagnetic immuni The TechnegasPlus Technegas Generator is intended for use in the electromagnetic environment specified below The customer or user of the TechnegasPlus Technegas Generator should assure that it is used in such an environment IEC 60601 test level Compliance level Electromagnetic Environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the TechnegasPlus Technegas Generator including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 Mhz Complied lt 3 V rms 150 kHz to 80 Mhz Recommended Separation Distance 22 WP y1 Radiated RF IEC 61000 4 3 3 V m 80 Mhz to 2 5 GHz Complied lt 3 V m 80 Mhz to 2 5 GHZ a 80 MHz to 800 MHz d 2 WP 800MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of the equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher fr
5. 8 kV air Complied 2 kV for power supply lines Complied 1 kV differential mode Complied 2 kV common mode Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 sec Complied Complied Complied Complied Complied lt 3 A m 50 amp 60 Hz NOTE Ur is the a c mains voltage prior to the application of the test level Mains power quality should be that of a typical commercial or hospital environment If the user of the TechnegasPlus Technegas Generator requires continued operation during power mains interruptions it is recommended that the TechnegasPlus Technegas Generator be powered from an uninterruptible power supply or battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment vita medical technegasplus generator manual 39 From IEC60601 1 2 Table 201 Guidance and manufacturer s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration
6. Technegas Generator chamber when the Patient Valve is closed or release Technegas into the atmosphere if the Patient Valve is opened and not delivering Technegas to a patient Installing the Resuscitator Bag Connect the Resuscitator Bag Non re breathing Valve Assembly to the East Breather Manifold connection located on the rear sloping face of the Mk2 Technegas Generator by pressing it firmly into position Installing the PAS Filter Check Valve and Pneumatic Control Line e Using the Pneumatic Control Line Silicon Hose connect the PAS Filter Check Valve to the Easy Breather via the hose connection located on the TechnegasPlus Generator Front Display Panel so that the hose is firmly in position Easy Breather Accessory Operating Procedure Preparation Before each use check the installation of the Technegas Easy Breather Resuscitator Bag following the procedure previously described in this manual e Produce Technegas in the normal way according to the Technegas Plus Generator User Manual instructions e Transport the Technegas Generator to the Camera room and fit a new PAS to the Technegas Generator e Couple the PAS Check Valve to the end of the PAS filter unit by pushing it firmly over the filter outlet rotate the Check Valve to engage it to the filter and lock it in position with the locking knob Do not over tighten the locking knob vita medical technegasplus generator manual 23 Caution Ensure there
7. available it is possible to carry out multiple crucible loadings by interrupting the automatic generation cycle after the evaporation phase Simmer this is done by pressing the CANCEL button TWICE in two seconds opening the drawer re filling and re evaporating Please note that the crucible does not require re wet ting with ethanol prior to re filling e To close the drawer press the Drawer Interlock Knob on the top FIRST then the CLOSE button Keep both depressed until the drawer is fully closed and the drawer light has gone out If either is released before the drawer has stopped moving it will immediately re open This two handed operation is a safety precaution Do not attempt to put anything in the drawer opening nor to interfere with the process as you may damage the seal of the generator Do not operate the mechanism if you suspect anything may obstruct normal operation vita medical technegasplus generator manual 16 The display will then read PRESS START TO INITIATE SIMMER e When START is pressed the chamber will be checked for correct sealing by a leak test then the simmering purging starts This cycle is 6 minutes in length indicated by a count down time that is displayed during this stage Only the CANCEL button is active during this time Gas Flow Monitor Gas flow into the unit is continuously monitored If the gas flow is too high or low because of an emptying bottle or a valve not fully on the proce
8. eg gaps between an elevator and the floor gamma camera rails and cables e Do not load the trolley with heavy items such as Gas Bottles for transport Always move Gas Bottles and other heavy equipment using specialised transport equipment that is appropriate for carrying such items vita medical technegasplus generator manual 12 OPERATING THE TECHNEGASPLUS GENERATOR Installation Requirements Power Supply The User must provide a mains power line dedicated for use with the TechnegasPlus Generator 200 to a 230 240V 50 60Hz rated at 20 Amperes Argon Gas Supply The User must provide High Purity or Laboratory Grade Argon gt 99 99 pure Warning Some Argon gas mixtures are sold for use in arc welding Argoshield They usually contain small quantities of oxygen and other gases These mixtures must not be used with the TechnegasPlus Generator as they are not appropriate for human use Additional items required a lmL Syringe capable of dispensing 0 1 ml Syringe shield Disposable gloves Pure ethanol greater than 95 Watch glass or Petrie Dish 1 ml needle less syringe Forceps supplied with Technegas Generator General Requirements e Assign an area within the Nuclear Medicine department preferably near the imaging room for production of Technegas and storage of the unit e Allow space for the safe storage of used crucibles and PAS for a minimum of five days before final disposal as non radioa
9. operation the User must ensure that TechnegasPlus Generator is allowed adequate time to charge its internal battery by following the instructions given in this manual While batteries may naturally fail over time they will last longer and give you better service if kept properly charged Precautions amp Warnings USE ONLY Solution of Sodium Pertechnetate 99 of European Pharmacopoeia grade or equivalent in the TechnegasPlus Generator Before adding Tc99m eluate always wet the crucible using ethanol adding the Pertechnetate immediately after Wetting the crucible ensures air cannot be trapped under the Pertechnetate and cause bubbling over of the crucible sides during the simmer process Do not use methylated alcohol as it may leave residues on evaporation that could lead to pyrolysis products in the gas generation stage Also care must be taken when handling Crucibles to avoid the introduction of foreign substances from any source Always use clean gloves and inspect the crucible at the time of installation into the TechnegasPlus Generator Ensure that the crucible is not overfilled The meniscus should be CONCAVE or FLAT not convex Always turn off the Argon gas when the supply is disconnected from the TechnegasPlus Generator to avoid waste For safety use the order of operations recommended by the Regulator supplier or manufacturer Dispose of the used consumables as contaminated waste both will be radioactive and biologically
10. repeated every 15 minutes thereafter Note that the burn stage cannot be commenced until after the check is completed and the prompt appears to START the burn e Press the START button now and the burn will commence raising crucible temperature above 2700 C for 15 seconds When the burn is complete the display will read VERIFYING BURN this message holds for 3 seconds and then changes to DISCONNECT THE MAINS PLEASE vita medical technegasplus generator manual 17 Your Technegas is now prepared and ready for inhalation by the patient Refer to the Section of this Manual on Administration of Technegas e Disconnect the Argon gas be sure to turn the Argon supply off at the regulator as recommended before disconnecting the Argon otherwise wastage will occur then wheel the machine to the camera room The Technegas is available to be administered for 10 minutes after generation This is indicated by a count down time on the display While the mains power has been disconnected the unit remains powered by an internal battery To save battery power and to prevent inadvertent release of Technegas the machine will disengage the Patient Release Valve It may be re engaged any time during the 10 minute Technegas availability period by following the displayed prompt and pressing the START key vita medical technegasplus generator manual 18 vita medical technegasplus generator manual 19 ADMINISTRATION OF TECHNEGAS Intr
11. senses that its ambient temperature is too high No more than two burns per hour is specified CLOCK SETTING vita medical technegasplus generator manual 30 CLOCK SETTING MESSAGES ROUTINES Indicates that the Clock Setting Routine has begun THE CLOCK HAS NOT YET BEEN SET The generator detects that the clock has not been set and requests the operator to follow the clock setting routine CLOCK SETTING HOUR Indicates that the operator may set the Hour of the clock CLOCK SETTING MINUTE Indicates that the operator may set the Minute of the clock CLOCK SETTING YEAR Indicates that the operator may set the Year of the clock CLOCK SETTING MONTH Indicates that the operator may set the Month of the clock CLOCK SETTING DAY Indicates that the operator may set the Day of the clock vita medical technegasplus generator manual 31 TECHNEGAS LABEL DESCRIPTIONS 1 ATTENTION SEE INSTRUCTIONS FOR USE International Symbol for See Instructions for Use 2 CAUTION THIS UNIT MUST BE USED IN ACCORDANCE WITH THE USER MANUAL CAUTION THIS UNIT MUST BE USED IN ACCORDANCE WITH USERS MANUAL This label is located on the front of the Generator Trolley and requests the user to consult their User Manual when using the Generator 3 OFF POWER DISCONNECTION FROM THE MAINS International Symbol for power OFF 4 ON POWER CONNECTION TO THE MAINS International Symbol for power ON
12. should call their local service providor vita medical technegasplus generator manual 43 EASY BREATHER PRINCIPLE OF DEVICE FUNCTION The Easy Breather Accessory has been developed to enable delivery of Technegas or Pertechnegas to any patient for whom a ventilation imaging procedure has been pre scribed Its operation is entirely pneumatic The Easy Breather Accessory operates in conjunction with the Technegas Generator being intended as an accessory for that device The function of the Easy Breather Accessory is to push the Technegas from the Technegas Generator chamber to a patient via the Patient Administration Set This is achieved by the use of the Easy Breather Accessory major com ponent a commercially available Resuscitator Bag Simply when the Resuscitator Bag is squeezed by the operator it pushes air from the bag into the Technegas Generator Chamber and then out of the Patient Delivery Valve to the patient via the standard Technegas Patient Administration Set A detailed Easy Breather Accessory function can be described as follows Patient Inhalation Cycle When the Easy Breather Accessory Resuscitator Bag is squeezed the following actions occur This description assumes that the Patient Delivery Valve is opened for delivery The Resuscitator Bag Duckbill valve opens and air is forced into the Technegas Generator Chamber via a Non Return Valve Assembly Another Non Return Valve Assembly from the chamber to free air shuts dir
13. vita medical technegasplus generator manual 32 5 SEALED LEAD ACID RECHARGEABLE BATTERY RATING 12V 1 2AH RECHARGABLE BATTERY Sealed NiCad Rating 12V 2 3Ah This label is located on the chassis adjacent to the battery and on batteries sup plied by Vita and defines the Generator battery rating 6 DEPRESS KNOB TO A POSITIVE STOP PATIENT DELIVER This label is located on the Generator cover and requests the operator to push the Patient Knob fully down to release the gas 7 PCB FUSE LABEL F1 Sub Miniature Fuse Type F Quick Acting Rating 125v 1 Amp This label shows a warning for the removal of the Printed Circuit Board from the unit and also defines the rating of the Printed Circuit Board Fuse in the Battery Charger line vita medical technegasplus generator manual 33 8 TRANSFORMER TAPPING LABEL 25922 Vita Medical Limited TGAS Mk2 8 MAIN TRANSFORMER ez 3 8 N N 2 CONTROL TRANSFORMER gt z N N N N A IN FUSE This label defines the voltages for the tappings of the Generator electrical transformers 9 ROTATE HOSE gt TO CONNECT N Rot D a REMOTE DELIVERY CHECK VALVE This label is located on the front of the Generator Cover surrounding the Delivery Nozzle It shows the direction of tur
14. CHNEGAS GENERATOR SPARES CODE DESCRIPTION 17838 Box of 50 Patient Administration Sets REST OF THE WORLD 17839 Box of 50 Patient Administration Sets EUROPE 10035 Patient Nose Clamp 1 only 10036 Pair of Forceps 10029 Ash Tray 10040 Argon Gas Regulator Assembly Complete ncludes Supply Hose 17510 Disposable Face Mask Refer to the Service Manual for details of Service parts vita medical technegasplus generator manual 45 REFERENCES References W M Burch P J Sullivan and C J McLaren Nuclear Medicine Communications 7 865 872 1986 H W Kroto J R Heath S C O Brien R F Curl and R E Smally Nature Vol 318 Nov 1985 pp 162 163 Friedlander S K Smoke dust and haze New York Wiley 1977 297 Clinical Nuclear Medicine Edited Maisley et al Chapman amp Hall 1983 pp73 Kereiakes J G Rosenstein M Handbook of Radiation doses in Nuclear medicine and diagnos tic X ray Florida CRC Press 1980 A full discussion of the technology and bibliography may be found at http www vitamedical com au vita medical technegasplus generator manual 46 vita medical technegasplus generator manual 47 NOTES AND UPDATES vita medical technegasplus generator manual 48 Vita Medical Limited
15. Easy Breather with Spontaneously Breathing Patients DO NOT squeeze the Resuscitator Bag until delivering Technegas to a Patient and then only after the Patient Valve is depressed Inadvertent use of the Resuscitator Bag may pres surise the Technegas Generator chamber when the Patient Valve is closed or release Technegas into the atmosphere if the Patient Valve is opened and not delivering Technegas to a patient Open the Patient Delivery Valve on the Technegas Generator and the person beside the Easy Breather Accessory then controls the breathing cycle of the patient by squeezing the bag to inflate the patient s lungs as the patient inhales Note that in normal operation the Resuscitator Bag should be squeezed with ONE HAND to deliver Technegas e Ensure that there is an inspiratory pause of 3 5 seconds at full inhalation to maximise the deposition of Technegas in the patient s lungs e Release hand pressure on the bag and the PAS Check Valve will open to allow the patient to exhale normally through the PAS filter e Repeat the process until the pre determined count rate on the gamma camera has been reached Once the count rate on the camera has reached the pre determined figure usually after one or two breaths release the Patient Delivery Valve on the Technegas Generator and remove hand pressure from the bag Allow the patient to take a further few breaths to clear the tubing and airways of residual Technegas Immediately the
16. MAJOR ERROR MESSAGES THE DRAWER FAILED TO OPEN IN THE TIME ALLOWED THE DRAWER FAILED TO CLOSE IN THE TIME ALLOWED CHAMBER FAILED LEAK TEST BAD OUTLET VALVE SIMMER CONTROL OUT OF RANGE ERROR IN READING PRESSURE CRUCIBLE FAILED TO REACH FULL TEMP CRUCIBLE EXCEEDED ALLOWABLE TEMP TRIAC FAILURE TURN OFF AND TRY AGAIN SWITCH OFF AND CALL MAINTENANCE PRESS CANCEL TO RESTART CHAMBER OPEN OR NO ARGON GAS GAS FLOW IS TOO LOW GAS FLOW IS TOO HIGH CASE TEMPERATURE TOO HIGH WAIT Indicates that the time allowed for the drawer to open automatically has been exceeded Indicates that the time allowed for the drawer to close automatically has been exceeded This indicates that the generator has found leak in the chamber and the most probable cause is that something may have jammed in the drawer front panel Check this then retry If still in error call for service This message is displayed when a fault has been detected in the gas outlet valve Try switching off then on again If still in error call for service This means that an adjustment to the Simmer Control is necessary Try switching off then on again If still in error call for service This message is displayed when there is a fault in the pressure detecting section Try switching off then on again If still in error call for service This message means
17. MS Mains Current Maximum 15 sec 20 Ampere RMS Fuse Battery Charging F1 Sub Miniature Fuse Type F Quick Acting Rating 1 Amp 125V Shipping Weight 130 Kg Shipping Size 1100 x 630 x 1190 Lx Wx H Floor Area 920x600 RESUSCITATOR BAG SPECIFICATIONS Storage Temperature 409 to 60 C Operating Temperature 18 C to 50 C Bag Volume Stroke Volume 1 6 litres The specifications quoted above are for a Hudson RCI Lifesaver Adult Reusable Resuscitator Bag For further information on the specifications of the Resuscitator Bag refer to the Resuscitator Bag Manual or manufacturer TechnegasPlus Technegas Generator vita medical technegasplus generator manual 41 EASY BREATHER MATERIALS Resuscitator Bag Component Valves Bag O Ring Valve Housings Non Return Valve Assembly Component Valve Body Connection Spigots Diaphragm Diaphragm Plate PAS Check Valve Component Valve Body O Ring Valve Diaphragm Assembly Screws Connector Hoses Component Connector to Check Valve vita medical technegasplus generator manual 42 Material Silicon Polyvinylchloride Epichlorohydrin Polysulphone Material ABS ABS Silicon ABS Material Aluminum Neoprene Rubber Stainless Steel Material Silicon Finish None None None None Finish None None None None Finish Clear Anodised None None None Finish None DOSIMETRY Radiation Dosimetry The radiation
18. RATING THE TECHNEGASPLUS TECHNEGAS GENERATOR 13 Installation Requirements Argon Gas Supply Additional Items Required General Requirements Battery Charging Operating the CANCEL Button Connecting the Argon Gas Operating the Gas Bottle Regulator Battery Charging Preparing and Fitting the Crucible Technetium Generator Eluate Gas Flow Monitor Case Temperature Too High ADMINISTRATION OF TECHNEGAS 20 Introduction Recommended Dose Administration to the Patient OPERATING THE TECHNEGASPLUS GENERATOR WITH THE EASY BREATHER ATTACHMENT 23 Precautions Installing the Resuscitator Bag Installing the PAS Filter Check Valve and Pneumatic Control Line Easy Breather Accessory Operating Procedure Using the Easy Breather with Spontaneously Breathing Patients Using the Easy Breather with Ventilated Patients OPERATING THE INTERNAL CRUCIBLE OVEN ACCESSORY 26 Precautions vita medical technegasplus generator manual 4 CONTENTS Section Title Page No 8 DISPOSAL OF CONTAMINATED ITEMS 27 List of Contaminated Items Disposal of Radioactively Contaminated Items 9 LCD MESSAGES AND DESCRIPTIONS 28 Operational Messages Major Error Messages Clock Setting Messages 10 TECHNEGASPLUS LABEL DESCRIPTIONS 32 11 USER MAINTENANCE AND SERVICE 36 User Maintenance Cleaning the Generator Changing Contact Assemblies Display Language Selection Preventive Maintenance Service General Service of Fault Conditions Preventive Maintenance Se
19. S THE GAS VALVE PRESS DRAWER INTERLOCK KNOB DRAWER MIDWAY OPEN OR CLOSE Indicates that the generator is purging cleaning the chamber prior to allowing the drawer to be opened Indicates that the drawer is ready to be opened to load a crucible Indicates that the operator should install a moistened crucible load the crucible with Technetium 99m and close the drawer The drawer can now be closed until it is a convenient time to change the contacts If the contacts are to be changed switch the power off with the drawer open and refer to the User Maintenance and Service Page XX Indicates that the operator should press the START button to begin the simmer cycle No action is required The generator is checking for connection to the gas supply No action required The Generator is carrying out a self test No action required The Generator is self testing for chamber seal No action required The generator is in the simmer stage Indicates that the operator should press the START button to begin the burn cycle Be sure you are ready to do so Indicates that you must press the START button for the machine to carry out a cleaning function pre burn if selected No action required Then generator is indicating that that a successful burn has been carried out No action required The generator is in the process of generating gas Indicates that the cleaning function is in progress Indication
20. absorbed dose to the lungs is somewhat higher for Technegas than for perfusion agents such as microspheres because Technegas does not clear from the lungs within the measurable life time of Tc 99m However whole body doses are comparable for a given amount of activity administered to a patient Absorbed dose adult 37MBq Administered Agent Lung Wholebody Technegas 4 5mGy 0 17mGy Microspheres mAA 2 9mGy 0 16mGy Reference R5 The Patient Retention of inhaled Technegas in the lung is dependent on the following parameters Depth of breathing Length of breath holding possible e Basic condition of the patient and lungs Number of breaths e The initial amount of Technetium added to the crucible e The time after generation that the patient breathes in the Technegas It is important to monitor the activity of the Technegas in the patient as the gas is adminis tered by watching the count rate of a posterior view on the gamma camera console Limit the dose to that indicated in the clinical notes 26 40MBq This is generally a maximum of approximately 2500 counts per second cps Note If thyroid is present in images or absorption of Technegas into the blood stream is noted operators should check that they have used Argon gas of 99 99 purity Operators should also ensure that they have used the correct eluate and have not over filled the crucible If such indications are present after checking these points then the operator
21. are no kinks in the pneumatic control line to the valve e Where required fit the oxygen bag accessory to the Resuscitator Bag adjust the hospital oxygen supply regulator to deliver about 10 l min oxygen from the standard hospital oxy gen outlet and plastic tube and couple the end of the tube to the oxygen inlet nozzle on the Resuscitator Bag If the patient is breathing spontaneously one person stands beside the patient s bed and operates the face mask and the Patient Delivery Valve The second person squeezes the bag in synchronisation with the patient s breathing Note that the face mask must be applied firmly to the patient s face and the Technegas Patient Delivery Valve pressed as the patient begins to inhale the first breath This ensures the initial pressurisation of the chamber is utilised to deliver Technegas with maximum effi ciency and minimum risk of leakage DO NOT squeeze the Resuscitator Bag until delivering Technegas to a Patient and then only after the Patient Valve is depressed Inadvertent use of the Resuscitator Bag may pres surise the Technegas Generator chamber when the Patient Valve is closed or release Technegas into the atmosphere if the Patient Valve is opened and not delivering Technegas to a patient DO NOT remove the mask once the procedure has started unless the Patient Delivery Valve has been closed or the activity will rapidly flow out into the room and cause contami nation problems Using the
22. ching the end of their life Pressing START at this stage will return the display to the normal screen message Indicates that the Contacts have reached the end of their life and must be changed The generator should now be switched off and the crucible contacts changed Care should be taken when changing the contacts as they may still be hot VML recommends allowing the contacts to cool before changing The above message occurs when 50 burns on the current crucible contacts have been completed At this stage START should be pressed and the drawer opened This message is displayed if the CANCEL button is pressed during the simmer stage It is not an error message and required no action This message is displayed when the power is switched back on after changing the contacts It confirms that the operator has changed the contacts and resets the Conact life counter Pressing the appropriate button OPEN or CLOSE will allow normal operation Indicates the remaining lifetime of the newly installed Contacts This message is displayed after 10 minutes has elapsed from Technegas generation The generator will switch itself off Indicates that you should re initiate the machine once you have completed delivery of Technegas This message indicates that the Technegas generator detected a possible LOW YIELD and requests the user check that the contacts are tight and in good condition vita medical technegasplus generator manual 29
23. ctive waste or as per the regulations and or licenses of your local Competent Authorities Battery Charging Plug the Technegas unit into the 20 ampere electrical power outlet and switch on using the main switch located at the rear of the generator A flat battery will not be evident until you try to deliver Technegas to your patient You are advised to leave the unit plugged in and turned on when not in use to keep the battery fully charged Operating the CANCEL Button The CANCEL button needs to be pressed TWICE within two seconds to activate CANCEL operation This eliminates the risk of canceling an operation accidentally vita medical technegasplus generator manual 13 Connecting the Argon Gas Before commencing the production cycle the Argon gas should be connected and turned on To do this plug in the gas outlet hose to the gas inlet of the Technegas Generator and ensure the self latching mechanism has engaged Where a high pressure gas bottle is used ensure that the bottle is securely fixed to a wall or as per your local Occupational Health and Safety requirements Operating the Gas Bottle Regulator Ensure that the regulator mechanism is firmly bolted to the gas supply Ensure that the regulator is fully off then turn on the gas at the bottle Rotate the main regulator valve until the low pressure gauge registers 14 litres per minute or as indicated by the green area of some regulators The following order
24. ecting air from the Easy Breather Accessory to the chamber When the Patient Delivery Valve is opened it provides the path for the Technegas to travel to the Patient through a standard Technegas Patient Administration Set PAS At the same time the pressure generated by squeezing the bag activates the PAS Check Valve Assembly thus blocking off the PAS exhalation path and ensuring that the Technegas to be delivered is directed only to the patient Patient Exhalation Cycle For Patient Exhalation the Easy Breather Accessory Resuscitator Bag is released The Resuscitator Bag re inflates itself via its own inflation valve assembly located at the bottom of the bag The pressure that operates the PAS Check Valve Assembly is also released this allows the Check Valve to open and the patient to exhale through the PAS Filter Assembly The Non Return Valve Assemblies return to their normal position waiting for the next pres sure cycle This process is repeated for each breath required to be delivered to the patient and is con tinued until the desired count rate for a study is achieved For further information the principles of operation for the Resuscitator Bag itself are described in the Operating Manual for the Resuscitator Bag supplied by Hudson RCI Easy Breather Accessory Assembly Flowchart To Patient via PAS Technegas Generator Assembly Atmosphere PAS Filter Check Valve vita medical technegasplus generator manual 44 TE
25. ectromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the TechnegasPlus Technegas Generator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the TechnegasPlus Technegas Generator as recommended below according to the maximum output power of the communications equipment Rated Maximum output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 1 WP 3 aT eee 0 37 0 37 Te 2 4 116 116 2 33 2 68 241 3 100 11 66 11 66 For transmitters rated at a maximum output power not listed above the recommended separation distance 4 in metres m be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in Watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people GENERAL Supply Voltage 200 V ac 5 220 V ac 5 230 240 V ac 5 adjustable as above by moving a Transformer Tapping Supply Frequency 50 60 Hz Mains Current Steady State lt 0 2 Ampere R
26. equency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the TechnegasPlus Technegas Generator is used exceeds the applicable RF compliance level above the TechnegasPlus Technegas Generator should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orientating or relocating the TechnegasPlus Technegas Generator Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m vita medical technegasplus generator manual 40 From IEC 60601 1 2 Table 206 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT and SYSTEMS that are not LIFE SSUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the TechnegasPlus Technegas Generator The TechnegasPlus Technegas Generator is intended for use in an el
27. gasPlus Generator The Technegas particles have been determined to be hexagonal platelets of metallic technetium Tc 99m closely encapsulated with a thin layer of graphitic carbon the size distribution of Technegas particles being around 30 60 nm with 80 of the particles being below 100 nm The ratio of the platelet thickness to diameter is around 1 10 in most cases Prolonged storage of Technegas promotes aggregation into larger particles and the migration of those particles to the walls of the chamber therefore 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 TechnegasPlus Generator inhibits the delivery to the patient and the chamber is automatically purged through a filter system to trap any excess Technegas How does the TechnegasPlus Generator Work The Vita TechnegasPlus Generator is an electro mechanical device weighing approximately 100 kilograms mounted on a trolley The TechnegasPlus Generator is fully self contained in terms of its own operation and radiation shielding and the various steps of Technegas pro duction are under the automated control of a microprocessor with front panel display prompts and simple push button operation The TechnegasPlus Generator is essentially a miniature high temperature furnace operated from mains voltage It uses a combination of graphite and an Argon atmosphere to reduce and t
28. gularly to prevent build up of any unwanted materials Any materials removed from the Crucible Oven or cleaning materials may become contaminated with radiation and should be handled and disposed of accordingly e Always follow your Department s Radiation Safety Guidelines when handling the Crucible Oven during cleaning If necessary consult your Radiation Safety Officer Transportation e The Technegas Plus Generator once installed is normally a permanent fixture and requires Service Intervention to uninstall and transport to preserve its integrity of operation e Vita Medical Limited recommends that you contact Vita Service for instructions and or assistance Storage Technegas Plus Generator once installed is normally a permanent fixture and requires Service Intervention to be uninstalled and to preserve the integrity of operation e Vita Medical Limited recommends that you contact Vita Service for instructions and or assistance vita medical technegasplus generator manual 37 SPECIFICATIONS Mk2 TECHNEGAS GENERATOR SPECIFICATIONS Protection Against Electric Shock The Degree of protection against electric shock is as per CLASS 1 TYPE B EQUIPMENT 7 denotes Applied Part Technegas Generator Environmental Ambient Temperature 10 40 C Ambient Air Pressure 70 106 kPa 700 1060mBar Ambient Humidity 0 95 non condensing Duty Cycle Two procedures per hour Consumables Argon Gas Argon Gas mus
29. hazardous after use In the interests of reliable operation and basic hygiene do not attempt to use a Patient Administration Set PAS on more than one patient Do not clean a PAS and attempt to use it again Both gas and liquid sterilising damage the valve mechanism and the wool based filter causing unreliable operation reduced radiation filtering ability and potential bacterial contamination of the machine Disposal of the PAS is mandatory after a single use vita medical technegasplus generator manual 10 Do not allow repairs to be carried out on the TechnegasPlus Generator by unauthorised personnel e Do not insert cleaning brushes or other foreign objects through the various valves openings or holes in the device or its consumables Damage may result which will make the unit unserviceable e Do not use the unit for any other purpose than that specifically indicated in the product literature e Do not autoclave the unit or its consumables as this will damage the circuitry and other components Safe Handling of Compressed Gas Cylinders Cylinders of compressed gas are very heavy and unstable and should be kept restrained at all times Follow your site s Occupation Health and Safety requirements for handling Compressed Gas Cylinders Vita Medical Limited can in no way be held liable for negligence in the restraining or handling of high pressure gas cylinders The responsibility of Vita Medical Limited is limited
30. hen vaporise Technetium Generator eluant sodium pertechnetate in a chamber It does this by first drying the eluant to remove the water from the saline carrier solution then raising the graphite crucible to an ideal temperature of 2750 C for a period between 3 and 15 seconds to produce the Technegas particles A pre burn step of 1650 C may also be introduced in the process prior to the final burn TECHNEGAS GENERATOR OPERATION PROCESS FLOWCHART 6 minute Purge Process Simmer Process Optional Delivery to Pre Burn gt Burn Process Patient L End of Cycle Return to Purge Process An inbuilt optical sensor detects the light given off by the hot crucible enabling the crucible temperature to be kept within specified limits during the heating cycles The burn process releases in excess of 60 of the Technetium into the vapour phase A manually operated exit port the Patient Valve in the chamber enables the patient to inhale the suspended Technegas 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 vita medical technegasplus generator manual 9 USER RESPONSIBILITY USER RESPONSIBILITY Incorrect equipment operation may occur if the operational environment is unsuitable The User of the TechnegasPlus Generator is responsible for providing an appropriate
31. hnegas Pertechnegas in the patient s lungs Release hand pressure on the bag and the PAS Check Valve will open to allow the patient to exhale normally through the PAS filter Repeat the process until the pre determined count rate on the gamma camera has been reached Once the count rate on the camera has reached the pre determined figure usually after one or two breaths release the patient delivery valve and immediately re couple the ventila tor system to the patient e Plug the patient connecting point of the PAS and place it into a plastic bag sealing it to prevent diffusion of activity into the camera room Remove the oxygen line from the Easy Breather Accessory if it was used vita medical technegasplus generator manual 25 OPERATING THE INTERNAL CRUCIBLE OVEN ACCESSORY WHERE FITTED If available if your market area the Mk2 Technegas Generator has been fitted with a Crucible Oven located inside the Drawer The Crucible Oven has been designed to overcome delays caused by carrying out multiple simmers when they have low activity from their generator The crucible oven allows the simultaneous preparation of up to 5 crucibles in an Argon atmosphere It is especially useful when the specific activity of Technetium is low e g at the end of the week Benefits are maximised when the technologist keeps a number of crucibles simmering during the day by progressively refilling for immediate use with the Technegas Generator
32. ilarly with additional consideration given to the interests of basic hygiene The crucible contacts should be changed as specified on pages 30 amp 31 and decay stored or disposed of as low level radioactive waste Any component removed or replaced from the internal systems must be handled as if it too were contaminated although the degree of contamination will depend on the length of time that the unit has stood since last used Disposal of Radioactively Contaminated Items The disposal of radioactive and infectious waste are subject to the regulations and or the appropriate licenses of the local Competent Authority or Regulatory Body Where advice on disposal is required Vita Medical Limited recommends that users contact these administrations vita medical technegasplus generator manual 27 MESSAGES AND DESCRIPTIONS WAIT PURGING CHAMBER OPEN DRAWER TO CHANGE CRUCIBLE LOAD CRUCIBLE THEN CLOSE DRAWER CHANGE CONTACTS OR CLOSE DRAWER PRESS START TO INITIATE SIMMER CHECKING FOR ARGON GAS CHECKING INLET amp OUTLET VALVES CHECKING FOR GAS LEAKS WAIT SIMMERING AND PURGING PRESS START TO INITIATE BURN PRESS START TO INITIATE THE CLEAN CYCLE BURN VERIFIED WAIT GENERATING GAS WAIT CLEAN CYCLE IN PROGRESS GAS READY TO USE WITHIN DISCONNECT THE MAINS PLEASE START RELEASE
33. n when connecting the Patient Administration Set to the Generator vita medical technegasplus generator manual 34 10 USE ARGON GAS ONLY A This label is located on the Low Pressure Argon Gas Regulator It specifies that only ARGON gas be used with the Generator 11 HOT SURFACE This symbol shown indicates the presence of a hot surface Caution Do not touch the hot surface as it may result in a burn injury vita medical technegasplus generator manual 35 USER MAINTENANCE AND SERVICE USER MAINTENANCE The following are the only user designated tasks for machine maintenance Extended clean ing should be carried out at the user s discretion Replacement of the Contact Assemblies should be carried out when prompted by the Technegas Generator A general Service of the Technegas Generator should be carried out by an authorised Service Person after every 150 burns or every SIX months This includes a general cleaning and lubrication of the internal components of the Technegas Generator and importantly calibration Please contact your Local Distributor or Vita Medical Limited to request a serv ice for your Technegas Generator Cleaning the Generator Clean the outside of the Technegas Generator with a soft cotton cloth For stubborn stains use a soft cotton cloth slightly moistened with water There are no user cleanable parts inside the machine Do Not use Detergents or solvents such as alcohol benzene or thinners as
34. ned by having the well of the crucible in the upright position The crucible axis should be at an approx 40 to the right hand side of the forceps e With a gloved left hand push the lever under the platform towards the back of the machine thus opening the contacts Place one end of the crucible into the left hand con tact and align the other end of the crucible with the right hand contact Slowly release the lever so that the right hand contact is made Unless good contact is made a low Technegas yield may result Rotate the crucible gently backwards and forwards on its axis a few times prior to simmering to ensure good contact Rotate the crucible to ensure the well cavity is upright vita medical technegasplus generator manual 15 CAUTION This procedure should be carried out carefully as the crucible is very brittle Load the crucible with Tc 99m generator eluant note the crucible must still be wet from the ethanol before the 99 is added if not repeat the wetting process use a syringe with a suitable needle and ensure that no bubble of liquid rises above the top of the crucible maximum volume 110ul for standard crucibles Technetium Generator Eluate Recommended crucible loading is between 400 and 900 MBq 10 25mCi of Sodium Pertechnetate in 0 14ml normal saline Thus a radioactive concentration of 4000 to 9000 MBq ml 100 to 250mCi ml is required If such a high radioactive concentration eluate is not
35. not available to the User Where problems occur please contact your local Service representative vita medical technegasplus generator manual 36 USER MAINTENANCE AND SERVICE TECHNEGASPLUS TECHNEGAS GENERATOR SERVICE Preventive Maintenance Service Generator To ensure long term operation and prevention of faults it is recommended that the Technegas Generator undergo a Preventive Maintenance service that includes calibration each 6 months Contact your local distributor for service General Service of Fault Conditions Where a fault is perceived in the operation of the Technegas Generator switch off the machine and call your local distributor for service Do not operate the Technegas Generator if it is faulty Preventive Maintenance and Service Easy Breather The Easy Breather part does not contain any user maintainable components In the case of failure or breakdown contact your local distributor of Vita products for Service advice Cleaning the Easy Breather Attachment e The external surfaces of the Easy Breather components may be wiped with a moist cloth and mild detergent or a sterilising medical wipe Follow your departmental guidelines for sterilisation of the Resuscitator Bag if required e Vita Medical Limited recommends that you refer to the instructions for Cleaning and Sterilisation contained in the Hudson RCI Resuscitator Bag Instruction Manual Cleaning the Crucible Oven e The Crucible Oven should be cleaned re
36. oduction For best results Technegas must be administered to the patient as soon as possible after being generated and certainly within the 10 minutes allowed The patient should be pre pared for administration during the Technegas generation process Ideally the patient should be positioned so that the activity entering the lungs can be monitored with a gamma camera as it is delivered Recommended Dose It is recommended that the User consult the Package Insert for the Crucible for details of Dosimetry The dose to the patient must be set by the User s Nuclear Medicine Department please consult your Department Director and or Radiation Safety Officer Administration to the Patient For the administration of Technegas to a patient Users should follow the details in the Package Insert for the Patient Administration Set PAS making reference to the Package Insert for the Crucible and this Manual as required Select the desired mouthpiece and allow the patient to familiarise themselves with it dur ing the preparation time of Technegas as described in the PAS Package Insert When ready fit a nose clip to the patient to prevent the patient breathing through the nose Patient posture affects the distribution profile of Technegas in the lungs in response to the gravitational effect on blood distribution Every effort should be made to ventilate the patient in the same posture as they will adopt for the MAA injection Experience has shown tha
37. of operations for turning on and off the Argon gas regulator is recom mended to avoid damage to the regulator itself Note that turning the main regulator valve clockwise turns the gas ON and counter clockwise turns it OFF TO TURN ON Bottle On first then Regulator On TO TURN OFF Regulator Off first then Bottle Off Low Pressure Gauge e Switch on the Technegas Generator initially the display will show the name Vita Medical Limited for 4 seconds If a purge has not been carried out since the last Technegas generation then it will then check if the drawer is closed and purge for 6 minutes This purge is to ensure that no radioactive Technegas from a previous test will escape into the atmosphere when the drawer is opened vita medical technegasplus generator manual 14 Please Note At the completion of the patient delivery process and the removal of the PAS from the Generator Vita recommends that the operator reconnects the Generator to the mains power switches it on and allows the 6 minute purge cycle to be carried out This will keep the machine cleaner and allow a period of battery recharging The display will then read OPEN DRAWER TO CHANGE CRUCIBLE To do this simply press OPEN There is no need to hold down the button however if necessary pressing the CANCEL button will immediately stop the drawer moving If there was a crucible in the machine from a previous burn it will have been broken so it or its piece
38. of time limit minutes seconds within which you must use the Technegas Indicates to the operator that they must disconnect the mains supply and the Argon gas Indicates to the operator to press the START button to unlock the patient delivery valve If the close button is pressed without first pressing the interlock knob this message will be displayed along with an audible alarm Indicates the position of the drawer Press Open or Close to continue vita medical technegasplus generator manual 28 NO CRUCIBLE OR BAD CONTACTS BURNS CONTACTS CHANGE CONTACT WITHIN BURNS Alternating with PRESS START TO CONTINUE SWITCH OFF AND CHANGE CONTACTS OPEN DRAWER AND CHANGE CONTACTS WAIT TEST CANCELLED CONTACTS CHANGED Scrolling with OPEN NO CLOSE YES THE CONTACT LIFE IS NOW 50 BURNS SORRY THE GAS IS TOO OLD TO USE PRESS CANCEL TO EXIT OR TURN THE MAINS ON LOW YIELD CHECK CONTACTS Indicates that the generator has no crucible installed or bad old or worn contacts If the crucible is present rotate the crucible back and forth a few times and try again Next try a new crucible followed by replacing the fixed contacts If still in error call for service This message indicates the total number of burns carried out and the remaining number of burns for the contacts Indicates to the operator that the contacts are approa
39. operational environment as defined by the specifications contained in this manual The TechnegasPlus Generator will meet the specifications described in this manual and in the package inserts and labels affixed to its consumables when it is installed and operated in accordance with those labels and instructions Keep the equipment in good order User Maintenance should be carried out by the user at the recommended periods defined in the manual to ensure reliable operation The User should also ensure that the manufacturer recommended 6 monthly services are strictly observed and carried out by your local distributor A defective product should not be used Any faults must be promptly reported Parts that are worn defective or suspected of any defect should be replaced immediately Vita recommends in the above instance that the User contact their local distributor for service advice The TechnegasPlus Generator bears regulatory marks to show compliance to Medical Device standards and regulations No part of this product should be repaired or modified in any way other than in accordance with those standards and the specifications defined by Vita Medical Limited The user of the TechnegasPlus Generator and its accessories shall take sole responsibility for any malfunction which results from the improper use or faulty maintenance improper repair damage alteration or modification by anyone other than an authorised Vita representative For correct
40. pe of Technegas into the room the following steps should be observed e Never open the patient delivery valve until the generator is coupled to the patient using the PAS or a Vita approved alternative mouthpiece e Always ensure that the patient continues to breathe through the PAS whilst connected to the Technegas unit with the delivery knob released for at least FIVE breaths after the cessation of Technegas inhalation This maneouvre clears Technegas from the delivery tubing and the patient s conducting airways e If you suspect that the patient will not comply with the mouthpiece of the administration set choose a more suitable delivery system from the range of alternatives available such as a face mask Note that this may be done in the course of the inhalation procedure vita medical technegasplusplus generator manual 11 Moving the TechnegasPlus Generator Safely e When moving the TechnegasPlus Generator disengage the wheel locks and always push or pull the unit by using the hand grip panels provided moving the TechnegasPlus Generator at a rate of no more than a slow walking pace Do not attempt to move the TechnegasPlus Generator with the wheel locks engaged or in a manner that you cannot safely control eg swinging the generator around or moving it at a speed faster than a slow walking pace Do not wheel the TechnegasPlus Generator Trolley over obstacles on the floor or over uneven surfaces that may block or seize the wheels
41. procedure is finished place the delivery tubing and mask PAS into a plastic bag and seal it to prevent diffusion of the residual gas into the camera room Remove the oxygen line from the Easy Breather Accessory if it was used Using the Easy Breather with Ventilated Patients Important only Qualified Medical personnel should operate the Technegas Easy Breather when used on Ventilated Patients DO NOT squeeze the Resuscitator Bag until delivering Technegas to a Patient and then only after the Patient Valve is depressed Inadvertent use of the Resuscitator Bag may pres surise the Technegas Generator chamber when the Patient Valve is closed or release Technegas into the atmosphere if the Patient Valve is opened and not delivering Technegas to a patient If the patient is on a ventilator ensure the coupling from the PAS to the ventilator connec tion is the correct size before commencing the process At the end of an exhalation open the circuit and couple the delivery tube to the ventilator system as close to the patient s mouth as possible Immediately open the Patient Delivery Valve on the Technegas Generator and the person vita medical technegasplus generator manual 24 beside the Easy Breather Accessory then controls the breathing cycle of the patient by squeezing the bag to inflate the patient s lungs e Ensure that there is an inspiratory pause of 3 5 seconds at full inhalation to maximise the deposition of Tec
42. r The risk of this can be reduced by carefully explaining the importance of the test to the patient allowing the patient a practice run with the mouthpiece page 20 and if necessary manually holding the lips closed with gloved hands A disposable mask may also be used For elderly patients a pleasant tasting gel is available to form a good seal around deeply fissured lips e After the patient has received the required amount of Technegas the patient valve should be released and the CANCEL button pressed TWICE in two seconds The unit will then shut down Cancel Button e Return the unit to the preparation area reconnect the Argon and electrical power switch on and allow the system to purge any residual Technegas immediately This will reduce the level of Carbon build up in the chamber in between service calls NOTE It is important to leave electrical power on to the unit to maintain battery charging TIP If the radioactive counts from your patient are too low the most probable cause is that the patient has defeated the mouthpiece and breathed room air vita medical technegasplus generator manual 22 OPERATING THE TECHNEGAS PLUS GENERATOR WITH THE EASY BREATHER ATTACHMENT WHERE FITTED PRECAUTIONS e Vita recommends that two operators carry out the delivery of Technegas to a patient using the Easy Breather Attachment The Easy Breather has been specially developed to assist with the delivery of Technegas to patients who are
43. re described in the Package Insert for the Crucible The chosen technique will depend on the health condition of the patient Method 1 Deep and slow breathing from the residual functional capacity calm and expiration followed by a 5 second pause of inspiration Method 2 Deep breathing with deep inspirations without pause Method 3 Rapid and deep inspirations from the residual functional capacity followed by a pause of about 5 seconds in inspiration TIP Encouraging the patient to imitate sucking drink through a straw seems to improve the efficiency of the inhalation e Watch the count rate and repeat this operation until the required activity is present in the lungs Release the delivery valve after the required activity is present and allow the patient to breathe air again through the mouthpiece tube assembly It is important for the patient to breathe through the PAS assembly for five to six breathing cycles after Technegas has been administered before removing it from the Technegas Generator to clear Technegas from the tubing and the patient airways NOTE 1 The delivery knob may be pressed and released continually during the inhalation process to regulate intake of Technegas It bypasses to room air when not depressed vita medical technegasplus generator manual 21 NOTE 2 Some patients may endeavor to breathe in and out around the mouthpiece thus defeating the effectiveness of the test and rapidly contaminating the room ai
44. rvice Easy Breather Cleaning the Easy Breather Attachment Cleaning the Crucible Oven Transportation Storage 12 SPECIFICATIONS 38 Protection Against Electric Shock Environmental Consumables Patient Administration Set Purge Filter Life Electromagnetic Compatibility General Resuscitator Bag Specifications Easy Breather Materials Specifications 13 DOSIMETRY 43 Radiation Dosimetry 14 EASY BREATHER PRINCIPLE OF DEVICE FUNCTION 44 15 TECHNEGASPLUS GENERATOR SPARES 45 16 REFERENCES 46 vita medical technegasplus generator manual 5 Interlock Knob PAS Connection Front Display Panel Cancel Button Drawer PICTORIAL REFERENCE REMOTE DELIVERY CHECK VALVE vita medical technegasplus generator manual 6 Delivery Knob Operating Buttons OPEN e CLOSE START Lead Acrylic Shield PICTORIAL REFERENCE Power On Lamp H Argon Gas Inlet Mains Switch Argon Gas Inlet Argon Gas Inlet with Hose connected Push back to connect Hose amp vita medical technegasplus generator manual 7 TECHNEGASPLUS TECHNEGAS GENERATOR vita medical technegasplus generator manual 8 INTRODUCTION What is Technegas Technegas is an ultra fine suspension of carbon nano particles labelled with technetium Tc 99m Technegas preparation takes place in a specially designed machine called the Techne
45. s should be removed first this is to ensure that the crucible is not accidentally re used There is a small stainless steel tray immediately below the crucible which is removable to facilitate this step The contacts which hold the crucible can be opened by using the lever under the platform on the left hand side CAUTION The lever and all other internal components of the generator are contaminated during Technegas generation Be sure disposable gloves are worn at this stage and take care to practice proper anti contamination procedures by removing and replacing gloves between touching contaminated and non contaminated components Preparing and Fitting the Crucible For the Preparation of Technegas Users should follow the details in the Package Insert for the Crucible Instructions for Use and handling making reference to the Package Insert for the Patient Administration Set PAS and this Manual as required Remove the crucible from its packaging using the forceps supplied with the Generator place it on a watch glass for suitable support Wet the well of the crucible by filling with absolute or 95 ethyl alcohol using 1 ml nee dle less syringe Draw back any excess ethanol with the same syringe leaving the crucible wet with ethanol e Pick up the wetted crucible using the forceps holding them in the right hand with the for ceps gripping the top and the bottom of the crucible not the sides Top and bottom are determi
46. ss will halt and the unit will beep while displaying the message to Gas Flow Too High Low As soon as the fault is corrected the machine will resume the process Case Temperature Too High The Technegas Generator has a recommended Duty Cycle of 2 Gas Generations only per hour Where used more frequently the Generator Chamber may become too hot for effec tive use In this case a message is displayed to indicate to the user that they must wait for the Generator to cool before continuing We have introduced a limit of 49 degrees Celsius to the case temperature above which the unit will not operate and the message Case Temperature Too High Wait will be displayed The unit is now ready for the final stage of Technegas generation Before proceeding further position the patient ready for inhalation and open a fresh PAS beside them as reassurance The patient must be familiar and comfortable with breathing through the mouthpiece while their nose is blocked with the clamp supplied If the patient defeats the mouthpiece on exhalation then a percentage of the inhaled Technegas can be released into the room This can cause a rise in camera background radiation The 6 minute simmer and purge routine creates a convenient time to rehearse the patient in the procedure and minimise the risk of failure If the generator is left longer than 15 minutes while preparing the patient then the generator will recheck the presence of argon gas This is
47. t be High Purity or Laboratory Grade 99 99 pure Patient Administration Set A Patient Administration Set PAS designed specifically for the Technegas unit It is manu factured from a Non toxic plastic material with a resin impregnated wool air filter The PAS is for single use only Purge Filter Life The Mk2 Technegas Generator is fitted with a long life Purge Filter The expected lifetime is a minimum of 3000 operational cycles The Purge Filter is assessed and replaced periodical ly as required during the Service of the machine The Purge Filter is not accessible by the User and must be replaced only by an approved Service provider vita medical technegasplus generator manual 38 Electromagnetic Compatibility From IEC 60601 1 2 the following declarations and guidance are provided for the Technegas Plus Technegas Generator From 60601 1 2 Table 201 Guidance and manufacturer s declaration electromagnetic emissions for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic emissions The TechnegasPlus Technegas Generator is intended for use in the electromagnetic environment specified below The customer or the user of the TechnegasPlus Technegas Generator should assure that it is used in such an environment The TechnegasPlus Technegas Generator uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearb
48. t wherever possible patients should be supine and the gamma camera positioned for a posterior view Body movement and breathing irregularities are greatly reduced if your patient is in a comfortable but restrained supine position yn CELE e When the patient is prepared press the START button to produce Technegas vita medical technegasplus generator manual 20 When prompted by the Technegas Generator Display disconnect the unit from the Argon gas and the mains power and wheel the machine to the patient Note that it is important to deliver the Technegas as soon as possible after it is generated Connect the open end of the tubing of the PAS to the generator by pushing it over the Technegas release port and locking the bayonet fitting with a small clockwise twist Encourage the patient to breathe normally through the mouthpiece Assure the patient at this time that they are breathing room air e Press the START button to release the patient delivery valve Start Button e When the patient is comfortable and confident breathing through the mouthpiece request the patient to exhale then press down the patient delivery knob firmly as the patient begins to inhale Patient Delivery Knob e Ask the patient to breathe in the Technegas described in the Mode of Administration section of the Crucible Package Insert using the breathing method best suited to the patient IMPORTANT The administration techniques a
49. that during the burn the temperature was incorrect and a low yield of Technegas could have resulted If low yields continue after checking replacing contacts call for service or further advice This message means that during the burn the temperature was incorrect and a low yield of Technegas could have resulted Indicates that the TRIAC controlling the burn temperature may have failed Call for service advice Indicates that the machine has had a failure and requires the power to be switched off and then back on again to reset the machine The generator has detected an error requiring service intervention Call service for advice Indicates that the operator needs to press the CANCEL button To operate press the CANCEL button twice in two seconds to cancel an operation and restart the generator Indicates that no pressure was detected in the generator chamber Normally this means that the Argon gas is either not connected or not turned on Other possible causes could be low pressure in the Argon cylinder or something jammed in the drawer front panel Indicates that the operator should check the settings of their Argon gas supply gauges to ensure correct flow rate The machine is not receiving enough Argon Gas Replace gas bottle if necessary Indicates that the operator should check their Argon gas supply gauges and hose to the machine to ensure correct flow rate The machine is receiving too much Argon Gas The Technegas
50. they will damage the finish of the unit Changing the Contact Assemblies The Technegas Generator automatically counts down the remaining burns for each new set of contacts installed The contacts must be changed every 50 Burns to ensure the untrou bled operation of the Technegas Generator When prompted to change the contacts open the drawer then switch off the power at the mains switch Loosen the Contact Clamping Screws on the top of each pedestal holding the contact assemblies in position Remove the worn contact assemblies Fit the new con tact assemblies ensuring that the contact areas are clean and that when in position the rear face of both contact assemblies is in contact with the register face of the pedestals Tighten the Contact Clamping Screws to clamp the contacts tightly Do not over tighten the screws as this may result in stripped threads necessitating major repairs Switch the Technegas Generator back on and the message Contacts Changed appears Press the Close Key to answer YES Change the contact assemblies as prompted every 50 burns Always use disposable gloves as contamination may be present refer Safety in Use Section Display Language Selection The TechnegasPlus Generator is programmed with a number of languages with English being the default On installation the language for your region if available will be set by the Service Person For safety access to language setting is
51. to the Technegas machine up to the low pressure regulator and where supplied by Vita the high pressure regulator Vita Medical Limited recommends that the Argon gas supply be piped in from an external location as is the usual practice with hospital reticulated gases Given the lifetime of the technology the investment in this safety precaution is minor Use of Gloves During the various steps of generation and use of Technegas the following considerations are paramount in maintaining a clean working environment and in minimising the risk of contamination Whenever the internal parts of the generator are handled or open during loading of new cru cibles and radioactivity or during contact replacement or any other procedure gloves must be worn Gloves must be removed and disposed of using standard radiation handling techniques immediately prior to touching anything else such as the drawer close interlock knob and the CLOSE button Traceability Please register ownership with your local distributor at the time of installation by complet ing the Warranty Card Should there be any change of ownership of the Generator then your local distributor should be notified in writing immediately From time to time service notes changes in literature device notifications etc may become necessary Vita Medical main tains traceability of its products as a requirement of the Regulatory Authorities Safe Patient Delivery of Technegas To avoid the esca
52. unable to co operate with the normal passive delivery system and if available in your market has been fitted to the TechnegasPlus Technegas Generator Vita recommends that two persons one of whom MUST be qualified and experienced with positive pressure breathing systems are needed to deliver these radioactive gas like tracers with minimum risk of creating leakage into the camera room and causing significant airborne contamination Note The requirements for qualifications of personnel experienced in the use of positive pressure breathing systems may differ between institutions or the health systems of various countries You must ensure that the personnel using the Technegas Easy Breather have relevant experience or experience as necessary under your institution regulations or health system requirements DO NOT use the Easy Breather device as a Resuscitation device Follow your departmental guidelines for controlling cross contamination To prevent biological contamination of the Easy Breather the Technegas Generator and the patient it is important that the resuscitator bag supplied with the Easy Breather be reserved for use only with the Easy Breather and not used for any other purpose DO NOT use the Technegas Easy Breather on pediatric patients DO NOT squeeze the Resuscitator Bag until delivering Technegas to a Patient and then only after the Patient Valve is depressed Inadvertent use of the Resuscitator Bag may pres surise the
53. y electronic TechnegasPlus Technegas Generator RF Emissions CISPR 11 RF Emissions Class A CISPR 11 Harmonic Emissions IEC 61000 3 2 Voltage Fluctuations flicker emissions IEC 61000 3 3 The TechnegasPlus Technegas Generator is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes Not Applicable Not Applicable From 60601 1 2 Table 202 Guidance and Manufacturer s declaration electromagnetic immunity for all EQUIPMENT and SYSTEMS Guidance and manufacturer s declaration electromagnetic immuni The TechnegasPlus Technegas Generator is intended for use in the electromagnetic environment specified below The customer or the user of the TechnegasPlus Technegas Generator should assure that it is used in such an environment 60601 Compliance Level Electromagnetic environment guidance Test level Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines 61000 4 11 Power frequency 50 60Hz magnetic field 61000 4 8 6kV contact 8kV air 2kV for power supply lines 1kV for input output lines 1kV differential mode 2kV common mode Complied 6 kV contact Complied
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