Technegas Generator User Manual
Contents
1. YIELD TEST DELAY TIME No action required Service Message Page 25 Doc Ref 10069 Revision J Page 25 of 36 European English Version 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 Tl O N THIS UNIT MUST BE USED IN A AU 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 Page 26 Doc Ref 10069 Revision J Page 26 of 36 European English Version TECHNEGAS LABEL DESCRIPTIONS SEALED LEAD ACID RECHARGEABLE BATTERY RATING 12V 1 2AH Sealed Lead Acid RECHARGABLE BATTERY i Rating 12V 1 2Ah A j This label is located on the chassis adjacent to the battery and on batteries supplied by Cyclomedica and defines the Generator battery rating 6 DEPRESS KNOB TO A POSITIVE STOP DEPRESS KNOB TO A POSITIVE STOP 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 WARNING WHEN AEMOVING THE CIRCUIT BOARD Ft Sub Miniature Fuse FIRST REMOVE THE TRIAC MOUNTING SCREWS Type F Quick Acting2. AND REAR CONNECTORS P3 AND P4 Rating 125 V 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 Page 27 Doc Ref 10069 Revision J Page 27 of 36 European English Version TECHNEGAS LABEL DESCRIPTIONS 8 TRANSFORMER TAPPING LABEL TRANSFORMER gt MAIN POWER BLACK NEUTRAL i WHITE 200V YELLOW 220V BLUE 230 240V TRANSFORMER CONTROL POWER BLACK NEUTRAL WHITE 200V i YELLOW 220V BLUE 230 240V This label defines the voltages for the tapping s of the Generator electrical transformers 9 ROTATE HOSE gt TO CONNECT oE mh O 4 ovate v INN a5 D This label is located on the front of the Generator Cover surrounding the Delivery Nozzle It shows the direction of turn when connecting the Patient Administration Set to the Generator Page 28 Doc Ref 10069 Revision J Page 28 of 36 European English Version TECHNEGAS LABEL DESCRIPTIONS 10 USE ARGON GAS ONLY A GON Gao p Mage A This label is located on the Low Pressure Argon Gas Regulator It specifies that only ARGON gas be used with the Generator YSE AL ATNO 11 INSTALLATION LABELS A PIVOT POINT DO NOT REMOVE REMOVE FOR INSTALLATION REMOVE FOR INSTALLATION REMOVE SIDE PANEL TO ROTATE GENERATOR A A PIVOT POINT DO NOT REMOVE RE
3. HIGH WAIT The Technegas senses that it s ambient temperature is too high No more than two burns per hour is specified 10 CHAMBER FAILED LEAK TEST This means that there is a slight leak in the chamber and the most probable cause is that something may be jammed in the drawer front panel Check this then retry If still in error call Service Page 20 Doc Ref 10069 Revision J Page 20 of 36 European English Version MESSAGES AND DESCRIPTIONS 11 CHAMBER OPEN OR NO ARGON GAS If no pressure is found in the chamber 10 seconds after opening the gas inlet valve this message will be displayed 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 12 CHANGE CONTACTS OR CLOSE 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 Section pages 30 amp 31 13 CHANGE CONTACTS WITHIN 9 BURNS scrolling with PRESS START TO CONTINUE If 41 burns have been completed on the Technegas Generator the above messages will be displayed This indicates that there are 9 burns left on the current crucible contacts When the 9 burns have been completed the Technegas Generator will not allow further burns until the crucible contacts have been changed Pressing S
4. START TO INITIATE BURN Press the START button to begin the burn cycle Be sure you are ready to do so 35 PRESS START TO INITIATE SIMMER Press the START button to begin the simmer cycle 36 SET TO GENERATE PERTECHNEGAS This message appears only when the Technegas Generator is used in conjunction with a Ventilation Assistance Unit VAU Page 22 Doc Ref 10069 Revision J Page 22 of 36 European English Version MESSAGES AND DESCRIPTIONS 37 SET TO GENERATE TECHNEGAS This message appears only when the Technegas Generator is used in conjunction with a Ventilation Assistance Unit VAU 38 SIMMER CONTROL OUT OF RANGE This means that an adjustment to the Simmer Control is necessary Try switching off then on again If still in error call Service 39 SORRY THE GAS IS TOO OLD TO USE This message is displayed when 10 minutes has elapsed after the Technegas generation cycle has been completed It means that the gas is no longer useable and a repeat of the entire Technegas Generation procedure is necessary if Technegas is still required 40 SWITCH OFF AND CALL MAINTENANCE The Generator has detected an error Call Service for advice 41 SWITCH OFF AND CHANGE CONTACTS scrolling with PRESS START TO CONTINUE The Technegas Generator should now be switched off and the crucible contacts changed If this is inconvenient at this stage then pressing START will display the message 42 THE GAS FLOW IS TOO HIGH The Generator detects a h
5. and the patient s conducting airways 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 Note that this may be done in the course of the inhalation procedure Moving the Technegas Generator Safely To avoid problems associated with moving the Technegas Generator please observe the following warnings When moving the Technegas Generator disengage the wheel locks and always push or pull the unit by using the handles provided moving the Technegas Generator at a rate of no more than a slow walking pace Do not attempt to move the Technegas 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 Technegas Generator Trolley over obstacles on the floor or over uneven surfaces that may block or seize the wheels eg gaps between an elevator and the floor gamma camera rails and cables 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 Page 8 Doc Ref 10069 Revision J Page 8 of 36 European English Version OPERATING THE TECHNEGAS GENERATOR Installation Requirements Power Supply The User must provide a mains power line dedicat
6. radioactive waste The PAS and mouthpieces should be treated similarly with additional consideration given to the interests of basic hygiene The Purge filter and 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 licences of the local Competent Authority Where advice on disposal is required Cyclomedica recommends that users contact these administrations Page 19 Doc Ref 10069 Revision J Page 19 of 36 European English Version MESSAGES AND DESCRIPTIONS 1 START RELEASES GAS VALVE Press the START button to unlock the patient delivery valve when the Technegas Generator is fitted with a manual valve 2 NO BOAT OR BAD CONTACTS When the simmer starts the power required to reach simmer temperature is monitored and if found to be in error the machine halts and displays this message Normally it will mean there is no crucible If the Pulmotec crucible is present rotate the crucible back and forth a few times and try again Next try a new Pulmotec crucible followed by repl
7. 2 Ampere RMS 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 1060 x 990 x 720mm Floor Area 920x600 CE Doc Ref 10069 Revision J Page 33 of 36 European English Version SPECIFICATIONS Page 33 DOSIMETRY Radiation Dosimetry Please refer to the package insert of the Pulmotec crucible for details on Dosimetry 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 Basic condition of the patient and lungs Number of breaths The initial amount of Technetium added to the Pulmotec crucible 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 Technegas is administered by watching the count rate of a posterior view on the gamma camera console Limit the dose to that indicated in the clinical notes 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 en
8. MOVE FOR b INSTALLATION REMOVE FOR INSTALLATION REMOVE SIDE PANEL TO ROTATE GENERATOR So A These labels are located on the bottom of the Generator Trolley top plate They define those screws to remove and those to leave in place when rotating the Trolley Top during the installation Two labels also define the side plate of the Trolley to remove when rotating the Trolley Top Page 29 Doc Ref 10069 Revision J Page 29 of 36 European English Version USER MAINTENANCE AND SERVICE USER MAINTENANCE The following are the only user designated tasks for machine maintenance Extended cleaning should be carried out at the user s discretion Replacement of the Exhaust Filter and 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 a calibration check Please contact your Authorised Representative to request a service 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 they will damage the fini
9. TART at this stage will return the display to the normal screen message 14 CHECKING FOR ARGON GAS No action required The Generator is checking for connection to a Gas supply 15 CHECKING FOR GAS LEAKS No action required The Generator is self testing for chamber seal 16 CHECKING INLET amp OUTLET VALVES No action required Generator self test 17 CLOSE PERTECHNEGAS OPEN TECHNEGAS This message appears only when the Technegas Generator is used in conjunction with a Ventilation Assistance Unit VAU 18 CONTACTS CHANGED Scrolling with OPEN NO CLOSE YES The above message is displayed when the power is switched back on after changing the contacts Pressing the appropriate button OPEN or CLOSE will allow normal operation 19 DISCONNECT THE MAINS PLEASE Disconnect the Mains supply and the Argon Gas 20 DRAW MIDWAY OPEN OR CLOSE Try closing the drawer further or opening fully If this does not work try switching off then on again If still in error call Service 21 ERROR IN READING PRESSURE 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 Service 22 GAS READY TO USE WITHIN 00 00 Indication of time limit minutes seconds within which you must use the Technegas Page 21 Doc Ref 10069 Revision J Page 21 of 36 European English Version MESSAGES AND DESCRIPTIONS 23 LOAD BOAT THEN CLOSE DRAWER Install the moistene
10. Technegas Generator User Manual 10069 European English Version Doc Ref 10069 Revision J Page 1 of 36 European English Version NOTICES Attention The information found in this manual is the latest information at the time of delivery However Cyclomedica reserves the right to change specifications and recommended procedures without prior notice Should this occur and affect the use of your Technegas Generator you will be advised of any upgrades or recommended procedural changes which will be accompanied by amendment sheets for this manual Copyright Copyright 1997 Cyclomedica All rights reserved The contents of this publication may not be reproduced in any form without the written permission of Cyclomedica Australia Pty Ltd 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 enquiries cyclomedica com au Page 2 Doc Ref 10069 Revision J Page 2 of 36 European English Version TABLE OF CONTENTS Section Title Page No 1 INTRODUCTION 5 What is Technegas 5 2 USER RESPONSIBILITY 6 Traceability 6 Cautions 6 3 SAFETY IN USE 7 Safe Handling of Compressed Gas Cylinders 7 Use of Gloves 7 Warnings 7 Safe Patient Delivery of Technegas 8 4 OPERATING THE TECHNEGAS GENERATOR 9 Installation Requirements 9 Power Supply 9 Argon Supply 9 Additional Items Required 9 Other Requirements 9 Connecting th
11. a comfortable but restrained supine position e Press the START button to produce Technegas Front Panel Start Button Page 16 Doc Ref 10069 Revision J Page 16 of 36 European English Version ADMINISTRATION OF TECHNEGAS e Disconnect the unit from the gas and mains power and wheel it to the patient e 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 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 Ask the patient to breathe in the Technegas described in the Mode of Administration section of the Pulmotec Crucible Package Insert using the breathing method best suited to the patient Page 17 Doc Ref 10069 Revision J Page 17 of 36 European English Version ADMINISTRATION OF TECHNEGAS IMPORTANT The administration techniques are described in the Package Insert for the Pulmotec Crucible The chosen technique will depend on the health condition of the patient Method 1 Deep and slow breathing from the residual fu
12. acing the fixed contacts If still in error call Service 3 WARNING CHECK FILTER This message is displayed if the Purge filter or filter lid is missing when the machine requires the use of Argon gas This would normally occur immediately after switch on Check the positioning of the Purge Filter and lid 4 AMBIENT PRESSURE OUT OF RANGE This means that the external ambient pressure is beyond the range of the limits of the generator Try switching off then on again If still in error call Service 5 BAD OUTLET VALVE 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 Service 6 BOAT EXCEEDED ALLOWABLE TEMP This message is displayed when the temperature of the Pulmotec crucible has exceeded the upper limits during the full burn stage Try repeating the entire Generation procedure again by switching off then on again If still in error call Service 7 BOAT FAILED TO REACH FULL TEMP LOW YIELD PRESS START TO CONTINUE You have the option here to press START to deliver Technegas produced or to repeat the complete generation procedure This message is a warning to carry out user maintenance by checking tightening the contacts If this message continues after checking replacing the contacts call Service for further advice 8 BURN VERIFIED No action required The generator is checking that a burn has been carried out 9 CASE TEMPERATURE TOO
13. ay be found at http www Cyclomedicamedical com au Page 37 Doc Ref 10069 Revision J Page 37 of 36 European English Version
14. d Pulmotec crucible Load the Pulmotec crucible with the sodium pertechnetate Tc 99m and close the drawer See Page 12 24 OPEN NO CLOSE YES The Generator requests the user to select a control option 25 OPEN DRAWER AND CHANGE CONTACTS scrolling with PRESS START TO CONTINUE 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 26 OPEN DRAWER TO CHANGE BOAT Open the drawer to load a Pulmotec crucible 27 PLEASE ENSURE THE OXYGEN IS ON This message appears only when the Technegas Generator is used in conjunction with a Ventilation Assistance Unit VAU 28 WAIT PURGING 3 00 The Generator is purging cleaning the chamber prior to allowing the drawer to be opened 29 PLEASE ENSURE THE OXYGEN IS ON This message appears only when the Technegas Generator is used in conjunction with a Ventilation Assistance Unit VAU 30 PRESS CANCEL IF FINISHED Press the CANCEL button when delivery of Technegas to the patient has been completed See Page 18 31 PRESS CANCEL TO RESTART Press the CANCEL button TWICE in 2 seconds to cancel an operation and restart the Generator 32 PRESS DRAWER INTERLOCK KNOB If the CLOSE button is pressed without first pressing the interlock knob this message will be displayed along with an audible alarm 33 PRESS START TO CONTINUE Press START to return to normal generator program 34 PRESS
15. e Argon Gas 9 Operating the Gas Bottle Regulator 10 Fitting the Purge Filter and Lid 10 Battery Charging 11 Operating the CANCEL Button 11 Operating the Technegas Generator 11 Preparing and Fitting the Pulmotec Crucible 12 Gas Flow Monitor 14 Case Temperature Too High 14 5 ADMINISTRATION OF TECHNEGAS 16 Introduction 16 Recommended Dose 16 Administration to the Patient 16 General Comment 18 6 DISPOSAL OF CONTAMINATED ITEMS 19 List of Contaminated Items 19 Disposal of Radioactively Contaminated Items 19 7 LCD MESSAGES AND DESCRIPTIONS 20 Operational Messages 20 Service Messages 25 8 TECHNEGAS LABEL DESCRIPTIONS 26 Page 3 Doc Ref 10069 Revision J Page 3 of 36 European English Version Section 9 10 11 12 13 Title USER MAINTENANCE AND SERVICE User Maintenance Cleaning the Generator Changing Contact Assemblies Changing the Purge Filter Service Preventive Maintenance Service General Service of Fault Conditions SPECIFICATIONS Protection Against Electric Shock Electromagnetic Compatibility Environmental Consumables General DOSIMETRY Radiation Dosimetry TECHNEGAS GENERATOR SPARES REFERENCES Doc Ref 10069 Revision J Page 4 of 36 European English Version TABLE OF CONTENTS Page 4 INTRODUCTION What is Technegas Technegas is an ultra fine suspension of carbon micro particles labelled with technetium Tc 99m Technegas preparation takes place in a specially designed machine called
16. ed for use with the Technegas Generator 200 to 230 240V 50 60Hz 20A Argon Supply High Purity or Laboratory Grade Argon 299 99 pure CAUTION Some gas mixtures are sold for use in argon arc welding such as Argoshield or welding grade Argon etc They usually contain small quantities of oxygen and other gases These mixtures must not be used as they are not appropriate for human use Technetium Generator Eluate Recommended Pulmotec crucible loading is between 400 and 900 MBq 10 25 mCi of Sodium Pertechnetate Tc 99m in an average Pulmotec crucible volume of 0 14mL normal saline Thus a radioactive concentration of 4000 to 9000 MBq mL 100 to 250 mCi mL is required f such a high radioactive concentration eluate is not available it is possible to carry out multiple Pulmotec 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 to be re wet with ethanol prior to re filling Additional items required a 1 mL Syringe for loading with Sodium Pertechnetate Tc 99m Syringe shield Disposable gloves Pure ethanol greater than 95 Watch glass or petrie dish 1 mL needleless syringe for wetting with ethanol Forceps supplied with Technegas Generator Other Requirements e Assign an area within the Nuclear M
17. ed 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 Generator in good order User Maintenance should be carried out by the User at the recommended periods defined in the manual to ensure reliable Generator 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 defects must be promptly recorded Parts that are worn defective or suspected of same should be replaced immediately Cyclomedica recommends in the above instance that the User contact their local distributor for service advice The Technegas Generator and its accessories bear regulatory marks to show compliance to Medical Device standards No part of this product should be repaired or modified in any way other than in accordance with those standards The user of the Technegas Generator and its accessories shall take sole responsibility for any malfunction which results from the improper use faulty maintenance improper repair damage alteration or modification by anyone other than an authorised Cyclomedica representative Traceability From time to time additions to the product file held by the user including but not limited to service notes changes in literature device notifications etc may become necessary A cond
18. edicine department preferably near the imaging room for production of Technegas and storage of the unit e Allow space for the safe storage of used Pulmotec crucibles and PAS for a minimum of five days before final disposal as non radioactive waste or as per the regulations and or licences of the local Competent Authorities e Be sure there is a general purpose electrical power outlet 10 Ampere or more which is rated to deliver 20 Ampere for 15 seconds Some circuit breakers 10 Ampere will open during the burn cycle however the incidence is rare and may be remedied by fitting a Slow blow standard circuit breaker or designated power outlet 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 requirements for safety Page 9 Doc Ref 10069 Revision J Page 9 of 36 European English Version OPERATING THE TECHNEGAS GENERATOR REAR PANEL GAS INLET 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 12 litres per minute o
19. el 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 Argon and electrical power switch on and allow the system to purge 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 General Comment If the radioactive signal from your patient is too low the most probable cause is that the patient has defeated the mouthpiece and breathed room air Page 18 Doc Ref 10069 Revision J Page 18 of 36 European English Version DISPOSAL OF CONTAMINATED ITEMS List of Contaminated Items The Pulmotec crucible The USED Patient Administration Set PAS Purge filter Crucible contacts Gloves NOTE The Pulmotec crucible and the Patient Administration Set are single use items and should be handled as follows Use disposable gloves during handling The Pulmotec 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 contacts and will contain a residue of radioactivity It should be treated as low level
20. gnetic Compatibility Requirements and Tests Electromagnetic Environment Guidance e Mains Power Quality for the Technegas Generator should be that of a typical commercial or hospital environment and is not for use on mains power in a domestic environment e Operators should consider an Electromagnetic Site Survey where their environment is expected to include sources of high level electromagnetic emissions Where the emissions of your site exceed applicable RF compliance levels observe the Technegas Generator for correct operation Under conditions where abnormal operation of the Technegas Generator is observed additional measures may be necessary such as relocating the Technegas Generator Environmental Ambient Temperature 8 30 C Ambient Air Pressure 75 108 kPa 750 1080mBar Ambient Humidity 0 95 non condensing Supply Voltage 200 230 240 V ac 5 Supply Frequency 50 60 Hz Consumables Argon Gas Argon Gas shall be High Purity or Laboratory Grade 299 99 pure Patient Administration Set A Patient Administration Set PAS designed specifically for the Technegas unit It is manufactured from a Non toxic plastic material with a resin impregnated wool air filter The PAS is for single use only Please note these plastic components can be shredded and recycled Page 32 Doc Ref 10069 Revision J Page 32 of 36 European English Version GENERAL Duty Cycle Two procedures per hour Mains Current Steady State lt 0
21. he patient should be prepared for administration during Technegas generation Ideally the patient should be positioned so that the activity entering the lungs can be monitored with a gamma camera Recommended Dose Refer to the Pulmotec crucible package insert for details on the dose to administer to the patient 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 Pulmotec Crucible and this Manual as required e Select the desired mouthpiece and allow the patient to familiarise themselves with it during 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 that 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
22. hnegas from a previous test will escape into the atmosphere when the drawer is opened If the Purge filter or filter lid is not installed an alarm will sound and the generator will not proceed until the filter and lid are correctly installed Refer page 31 for correct installation Please Note At the completion of the patient delivery process and the removal of the PAS from the Generator Cyclomedica recommends that the operator reconnects the Generator to the mains power switches it on and allows the 3 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 BOAT e To do this simply press OPEN There is no need to hold the button however if necessary CANCEL 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 pieces should be removed first this is to ensure that the Pulmotec crucible is not accidentally re used Page 11 Doc Ref 10069 Revision J Page 11 of 36 European English Version OPERATING THE TECHNEGAS GENERATOR There is a small stainless steel tray immediately below the crucible which is removable to facilitate this step The contacts which hold the Pulmotec 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 conta
23. igh gas flow The procedure resumes automatically when gas flow is reduced to the correct level 43 THE GAS FLOW IS TOO LOW Check argon gas supply gauges and lines to machine to ensure correct flow Replace gas bottle if necessary 44 TRIAC FAILURE Try repeating the entire Generation procedure again by switching off then on again If still in error call Service 45 TURN OFF AND TRY AGAIN Turn Generator off and try procedure again 46 WAIT GENERATING GAS No action required The Generator is in the process of generating Technegas 47 WAIT PURGING CHAMBER No action required The Generator is clearing the chamber of any remaining Technegas 48 WAIT SIMMERING PURGING No action required The Generator is in the Simmer stage 49 WAIT TEST CANCELLED This message is displayed if the CANCEL button is pressed during the simmer stage It is not an error message and requires no action 50 START ENABLES GAS VALVE Press the START button to unlock the patient delivery valve when the Technegas Generator is fitted with an electronic valve Page 23 Doc Ref 10069 Revision J Page 23 of 36 European English Version MESSAGES AND DESCRIPTIONS 51 XXX BURNS CONTACTS XX MORE This message indicates the total number of burns and the remaining number of burns for the contacts 52 LOW YIELD CHECK CONTACTS This message indicates that the Technegas Generator detected a possible LOW YIELD and requests the user check that the contact
24. ioactively contaminated items Purge Filter Purge Filter Lid SERVICE Preventive Maintenance Service To ensure long term operation and prevention of faults it is recommended that the Technegas Generator undergo a Preventive Maintenance service 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 For Technegas Generator Service call your local distributor Page 31 Doc Ref 10069 Revision J Page 31 of 36 European English Version SPECIFICATIONS TECHNEGAS GENERATOR SPECIFICATIONS Protection Against Electric Shock The Degree of protection against electric shock is as per CLASS 1 TYPE B EQUIPMENT R denotes Type B Applied Part Electromagnetic Compatibility The risks associated with the effects of Electromagnetic Emissions and Immunity of the Technegas Generator have been assessed during a comprehensive Risk Analysis following international standards The risks associated were determined to be low and the Technegas Generator is unlikely to cause any interference with other equipment The Technegas Generator complies with the Immunity and Emissions Class A compliance requirements of IEC60601 1 2 Medical Electrical Equipment General Requirements for Safety Collateral Standard Electroma
25. ition of sale is therefore traceability of the product at all times Please register ownership with your local distributor at the time of installation by completing the Warranty Card Should there be any change of ownership of the Generator then your local distributor should be notified in writing immediately Cautions Before use always wet the Pulmotec crucible using ethanol adding the pertechnetate Tc 99m immediately after 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 Pulmotec 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 Technegas Generator Ensure that the Pulmotec 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 Technegas 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 radioactive and biologically hazardous Page 6 Doc Ref 10069 Revision J Page 6 of 36 European English Version SAFETY IN USE Safe Handling of Compressed Gas Cylinders Cylinders of compressed gas are very heavy and unstable if left standing without some restraining mechanism Cyc
26. lomedica 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 In any case no gas cylinder should be stored without a restraint usually a bracket and chain to prevent falling The responsibility of Cyclomedica is limited to the Technegas machine up to the low pressure regulator and where supplied by Cyclomedica the high pressure regulator The company can in no way be held liable for negligence in the restraining or handling of high pressure gas cylinders 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 crucibles and radioactivity or during contact replacement or any other procedure gloves must be worn unless the unit has not been used for at least three days Gloves must be removed and disposed of using standard techniques immediately prior to touching anything else such as the drawer close interlock knob and the CLOSE button e USE ONLY Solution of Sodium Pertechnetate Tc 99m of European Pharmacopoeia grade or equivalent in the Technegas Generator e In the interests of reliable operation and basic hygiene do not attempt to u
27. minated 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 Contacts Ash Tray Preparing and Fitting the Pulmotec Crucible For the Preparation of Technegas Users should follow the details in the Package Insert for the Pulmotec Crucible Instructions for Use and handling making reference to the Package Insert for the Patient Administration Set PAS and this Manual as required Note For the purposes of accuracy the words electrode and Pulmotec crucible appear in this manual On the Technegas Generator display they appear as CONTACT and BOAT or CRUCIBLE respectively e Remove the Pulmotec crucible from its packaging using the forceps supplied with the Generator and place it on a watch glass for suitable support e Wet the well of the Pulmotec crucible by filling with absolute or 95 ethyl alcohol using a 1 mL needle less syringe Draw back any excess ethanol with the same syringe leaving the crucible wet with ethanol Page 12 Doc Ref 10069 Revision J Page 12 of 36 European English Version OPERATING THE TECHNEGAS GENERATOR e Pick up the wetted Pulmotec crucible using the forceps holding them in the right hand with the forceps gripping the top and the bottom of the crucible not the sides Top and bottom are deter
28. mined by having the well of the Pulmotec 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 Pulmotec crucible into the left hand contact and align the other end of the Pulmotec 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 Pulmotec crucible gently backwards and forwards on its axis a few times prior to simmering to ensure good contact Rotate the Pulmotec crucible to ensure the well cavity is upright Ji Lever L H Contact R H Contact Well Cavity 40 Degrees CAUTION This procedure should be carried out carefully as the crucible is very brittle e Load the Pulmotec crucible with Eur Ph sodium pertechnetate Tc 99m generator eluant note the crucible must be wet from the ethanol before the solution of sodium pertechnetate Tc 99m is added use a 1mL syringe with a suitable needle and ensure that no bubble of liquid rises above the top of the Pulmotec crucible maximum volume 110ul meniscus concave or flat 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 go
29. nctional 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 HINT 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 e 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 this assembly for five to six breathing cycles after Technegas has been administered 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 NOTE 2 Some patients may endeavour to breathe in and out around the mouthpiece thus defeating the effectiveness of the test and rapidly contaminating the room air 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 16 and if necessary manually holding the lips closed with gloved hands For elderly patients a pleasant tasting g
30. ne out Page 13 Doc Ref 10069 Revision J Page 13 of 36 European English Version OPERATING THE TECHNEGAS GENERATOR Draw Interlock Knob Close Button 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 CAUTION WHENEVER THE GENERATOR IS NOT IN USE THE DRAWER MUST BE CLOSED TO AVOID ACCIDENTAL CONTAMINATION OF PERSONNEL 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 If it is necessary to double dose the Pulmotec crucible ie not enough activity could be added in one loading then press the CANCEL button TWICE within two seconds at the end of the simmering purging stage This will restart the program allowing the drawer to be opened again There is no need to re wet the crucible with alcohol 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 n
31. ot fully on the process 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 resumes the process Case Temperature Too High The Technegas Generator has a Duty Cycle of 2 Gas Generations per hour Where used more frequently the Generator Chamber may become too hot for effective use In this case a message is displayed to indicate to the user that they must wait for the Generator to cool before continuing Page 14 Doc Ref 10069 Revision J Page 14 of 36 European English Version OPERATING THE TECHNEGAS GENERATOR A limit of 48 degrees Celsius has been introduced to the case temperature above which the unit will not operate This should not pose any problem if the machine is run no more frequently than twice an hour the duty cycle specified as maximum in this manual 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 six minute simmer and purge routine creates a convenient time to rehearse the patient in the
32. 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 repeated every 15 minute 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 the Pulmotec crucible temperature above 2550 C for 15 seconds Your Technegas is now prepared and ready for inhalation by the patient Refer to the Section of this Manual on Administration of Technegas Front Panel Start Button The display will then read VERIFYING BURN this message holds for 3 seconds and then changes to DISCONNECT THE MAINS PLEASE e Also 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 countdown time on the display While the mains power has been disconnected the unit remains powered by an internal battery Page 15 Doc Ref 10069 Revision J Page 15 of 36 European English Version ADMINISTRATION OF TECHNEGAS Introduction Once generated Technegas must be administered to the patient as soon as possible and certainly within 10 minutes of generation T
33. r as indicated by the green area of some regulators The following order of operations for turning on and off the Argon gas regulator is recommended to avoid damage to the regulator itself TO TURN ON Bottle On first then Regulator On TO TURN OFF Regulator Off first then Bottle Off Jow pressure gauge main regulator valve Fitting the Purge Filter and Plug Lid Check that the purge filter and plug lid are correctly installed in the top of the generator Page 10 Doc Ref 10069 Revision J Page 10 of 36 European English Version OPERATING THE TECHNEGAS GENERATOR Plug Lid Purge Filter Battery Charging Plug the Technegas unit into the electrical power outlet and switch on using the main switch located at the rear of the generator You are advised to leave the unit plugged in and turned on when not in use to keep the battery fully charged A flat battery will not be evident until you try to deliver Technegas to your patient Operating the CANCEL Button The CANCEL button needs to be pressed TWICE within two seconds to activate a CANCEL operation This eliminates the risk of cancelling an operation accidentally OPERATING THE TECHNEGAS GENERATOR e Switch on the Technegas Generator initially the display will show the name Cyclomedica for 4 seconds If the purge has not been carried out then it will then check if the drawer is closed and give a 3 minute purge This purge is to ensure that no radioactive Tec
34. s are tight and in good condition 53 BATTERY ON CHARGE This message indicates that the Technegas Generator is in the Battery Charge mode Switch the Generator off and then on again to restart normal operation Page 24 Doc Ref 10069 Revision J Page 24 of 36 European English Version MESSAGES AND DESCRIPTIONS Where any one of the following Service Messages are displayed call Service to seek advice These messages are for functions not available to the User 1 PURGE TEST OFF No action required Service Message 2 SIMMER TEST ON No action required Service Message 3 TEST PATIENT VALVE OFF No action required Service Message 4 YIELD TEST DELAY TIME No action required Service Message 5 YIELD TEST OFF No action required Service Message 6 YIELD TEST PURGING No action required Service Message 7 2500C TEST OFF No action required Service Message 8 ADJUST CLOCK FREQUENCY OFF No action required Service Message 9 BATT 14 4V No action required Service Message 10 BATTERY CHARGER TEST OFF No action required Service Message 11 CASE TEMP 25 6C No action required Service Message 12 LEAK TEST 0 0 kPa No action required Service Message 13 FULL BURN TEST No action required Service Message 14 OPTICAL ALIGNMENT TEST No action required Service Message 15 PATIENT VALVE ELECTRIC No action required Set up message 16 PATIENT VALVE MANUAL No action required Set up message 17
35. se 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 and potential bacterial contamination of the machine Disposal of the PAS is mandatory after a single use e Do not allow repairs to be carried out on the Technegas 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 Page 7 Doc Ref 10069 Revision J Page 7 of 36 European English Version SAFETY IN USE Safe Patient Delivery of Technegas To avoid the escape of Technegas into the room the following steps should be observed Never open the patient delivery valve until the generator is coupled to the patient using the PAS or a Cyclomedica approved alternative mouthpiece 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 manoeuvre clears Technegas from the delivery tubing
36. sh of the unit Changing Contact Assemblies Open the drawer then switch off the power at the mains switch Loosen the 4 x M5 screws two in each pedestal holding the contact assemblies in position Remove the worn contact assemblies Fit the new contact 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 4 x M5 screws to clamp the contacts tightly Do not overtighten the screws as this may result in stripped threads necessitating major repairs Change the contact assemblies every 50 burns Use disposable gloves as contamination may be present refer Safety in Use Section 2x MS screws asc register face of pedestal rear face of electrode assembly Page 30 Doc Ref 10069 Revision J Page 30 of 36 European English Version USER MAINTENANCE AND SERVICE Changing the Purge Filter It is essential that the purge filter be changed after every 50 burns ie when the Technegas Generator prompts you to Change the Contacts Use disposable gloves as the old filter is contaminated refer Safety in Use Section With the power switched on the filter is changed by lifting the metal lid on the top of the generator then removing the old filter by rotating it slightly clockwise it has a bayonet type fitting Replace with a new filter and replace lid Dispose of the old filter as per normal procedure for rad
37. sure 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 should call their local service provider Page 34 Doc Ref 10069 Revision J Page 34 of 36 European English Version Page 35 Doc Ref 10069 Revision J Page 35 of 36 European English Version CODE 17838 17839 10035 10036 10029 10039 17544 17605 10040 TECHNEGAS GENERATOR SPARES DESCRIPTION Box of 50 Patient Administration Sets REST OF THE WORLD Box of 50 Patient Administration Sets EUROPE Patient Nose Clamp 1 only Pair of Forceps Ash Tray User Manual Maintenance Pack Pulmotec Crucibles Pack of 10 Argon Gas Regulator Assembly Complete Includes Supply Hose Refer to the Service Manual for details of Service parts Doc Ref 10069 Revision J Page 36 of 36 European English Version Page 36 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 diagnostic X ray Florida CRC Press 1980 A full discussion of the technology and bibliography m
38. the Technegas Generator where a solution of sodium pertechnetate Tc 99m is loaded into the Pulmotec crucible and evaporated until dry Technegas is then generated by heating to 2550 C in an atmosphere of pure argon The Technegas particles have been determined as being 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 Technegas is intended to be administered to the patient within 10 minutes of its generation After 10 minutes to prevent accidental use of expired diagnostic agent the Technegas Generator inhibits the delivery to the patient and the chamber is automatically purged to a filter system to trap excess Technegas Note that prolonged storage of Technegas promotes aggregation into larger particles and the migration of those particles to the walls of the chamber Page 5 Doc Ref 10069 Revision J Page 5 of 36 European English Version USER RESPONSIBILITY User Responsibility The User of the Technegas Generator is responsible for providing an appropriate operational environment as defined by the specifications contained in this manual Incorrect equipment operation may occur if the operational environment is unsuitable The Technegas Generator will meet the specifications describ
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