Tec 5 Continuous Operation and Maintenance Manual
Flow Vaporizer
User Responsibility
This Product will perform in conformity with the description thereof contained in this operating manual and accompanying labels and/or inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided. This Product must be checked periodically. A defective Product should not be used. Parts that are broken, missing, plainly worn, distorted or contaminated should be replaced immediately. Should such repair or replacement become necessary, Datex-Ohmeda recommends that a telephonic or written request for service advice be made to the nearest Datex-Ohmeda Field Service Support Center. This Product or any of its parts should not be repaired other than in accordance with written instructions provided by Datex-Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be altered without the prior written approval of Datex-Ohmeda’s Quality Assurance Department. The user of this Product shall have the sole responsibility for any malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Datex-Ohmeda.
CAUTION w U. S. Federal and Canadian law restrict this device to sale by or on the order of a licensed medical practitioner. Outside the U. S. A. and Canada, check local laws for any restrictions that may apply.
Datex-Ohmeda products have unit serial numbers with coded logic which indicates a product group code, the year of manufacture and a sequential unit number for identification.
AAA A 12345
This alpha character indicates the year of product manufacture and when the serial number was assigned; “Y” = 1995, “Z” = 1996, “A” = 1997, etc. “I” and “O” are not used.
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Tec 5 Continuous
Flow Vaporizer
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Contents |
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Page |
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1.0 |
Introduction .................................................... |
1 |
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1.1 |
Operation And Maintenance Manual...................................................... |
1 |
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1.2 |
Precautions............................................................................................. |
1 |
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1.3 |
Symbols.................................................................................................. |
1 |
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2.0 |
Servicing Policy ............................................... |
2 |
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3.0 |
Description ..................................................... |
3 |
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3.1 |
General.................................................................................................... |
3 |
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3.2 |
Control |
Dial............................................................................................. |
3 |
3.3 |
Safety |
Interlocks..................................................................................... |
3 |
3.4 |
Vaporizer Identification Label................................................................ |
4 |
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4.0 |
Operating Instructions ........................................ |
4 |
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4.1 |
General.................................................................................................... |
4 |
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4.2 |
Vaporizer Mounting Procedure.............................................................. |
5 |
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4.3 |
Checking For Correct Mounting Of The Vaporizer................................ |
6 |
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4.4 |
Turning ON The Vaporizer...................................................................... |
6 |
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4.5 |
Vaporizer Removal................................................................................. |
6 |
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4.6 |
Filling And Draining................................................................................ |
7 |
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4.6.1 |
General.................................................................................................... |
7 |
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4.6.2 |
Filling A Vaporizer Which Incorporates A Screw Cap ..................Filler |
7 |
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4.6.3 |
Draining A Vaporizer Which Incorporates A Screw Cap ..............Filler |
8 |
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4.6.4 |
Filling A Vaporizer Which Incorporates A Keyed ..........................Filler |
9 |
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4.6.5 |
Draining A Vaporizer Which Incorporates A Keyed Filler................... |
10 |
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4.6.6 |
Filling A Vaporizer Which Incorporates A Quik-Fil™ .................Filler |
11 |
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4.6.7 |
Draining A Vaporizer Which Incorporates A Quik-Fil™ ..............Filler |
12 |
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5.0 |
Maintenance .................................................. |
13 |
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5.1 |
Schedule............................................................................................... |
13 |
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5.1.1 |
Every Two Weeks................................................................................. |
13 |
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5.1.2 |
Every Three Years................................................................................ |
13 |
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5.2 |
Cleaning................................................................................................ |
13 |
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5.3 |
Contamination...................................................................................... |
14 |
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5.4 |
Repairs.................................................................................................. |
14 |
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6.0 |
Principle Of Operation ....................................... |
15 |
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6.1 |
Interlock Mechanism............................................................................ |
15 |
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6.2 |
Selectatec Series Mounted Manifold Gas Circuit................................ |
17 |
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6.3 |
Vaporizer Valve And Sump Assembly................................................. |
18 |
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6.4 |
Gas Flow Through The Vaporizer......................................................... |
19 |
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6.4.1 |
General.................................................................................................. |
19 |
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6.4.2 |
By-pass Circuit..................................................................................... |
19 |
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6.4.3 |
Vaporizing Chamber Circuit................................................................. |
19 |
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7.0 |
Performance .................................................. |
21 |
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7.1 |
Performance Curves............................................................................. |
21 |
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7.1.1 |
Isotec 5%.............................................................................................. |
21 |
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7.1.2 |
Fluotec 5%............................................................................................ |
22 |
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7.1.3 |
Enfluratec 5%....................................................................................... |
23 |
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7.1.4 |
Sevotec 5%........................................................................................... |
24 |
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7.1.5 |
Sevotec 8%........................................................................................... |
25 |
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7.2 |
Effects |
Of Variables.............................................................................. |
26 |
7.2.1 |
Anaesthetic Agent Consumption......................................................... |
26 |
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7.2.2 |
Temperature......................................................................................... |
26 |
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Tec 5 Vaporizer |
Contents 1 |
O & M Manual Part No. 1105-0100-000 |
August 1999 |
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Contents |
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Page |
7.2.3 |
Barometric Pressure............................................................................ |
26 |
7.2.4 |
Back Pressure (Steady)........................................................................ |
27 |
7.2.4.1Low And Moderate Pressures27
7.2.4.2High Pressures 27
7.2.5 |
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Back Pressure (Fluctuating)................................................................. |
27 |
7.2.6 |
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Carrier Gas Composition...................................................................... |
27 |
7.2.7 |
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Time Out Of Service............................................................................. |
27 |
7.2.8 |
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Other Variables..................................................................................... |
28 |
8.0 |
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Checking The Calibration ................................... |
28 |
9.0 |
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Analytical Techniques ....................................... |
29 |
10.0 |
Specification .................................................. |
30 |
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10.1 |
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Calibration............................................................................................. |
30 |
10.2 |
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Resistance To Gas Flow With Vaporizer Out Of Circuit...................... |
30 |
10.3 |
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Liquid Capacity..................................................................................... |
30 |
10.4 |
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Weight And Dimensions...................................................................... |
30 |
10.5 |
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Environmental Conditions.................................................................... |
30 |
10.6 |
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Performance......................................................................................... |
30 |
11.0 |
Warranty ....................................................... |
31 |
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Illustrations |
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Fig. |
1 |
Vaporizer Identification Label................................................................ |
4 |
Fig. |
2 |
Vaporizer Mounting Procedure.............................................................. |
5 |
Fig. |
3 |
Locking The Vaporizer On To A Manifold.............................................. |
5 |
Fig. |
4 |
Turning ON The Vaporizer...................................................................... |
6 |
Fig. |
5 |
Unlocking The Vaporizer From A Manifold............................................ |
6 |
Fig. |
6 |
Filling A Vaporizer Which Incorporates A Screw Cap ..................Filler |
7 |
Fig. |
7 |
Draining A Vaporizer Which Incorporates A Screw Cap ..............Filler |
8 |
Fig. |
8 |
Filling A Vaporizer Which Incorporates A Keyed ..........................Filler |
9 |
Fig. |
9 |
Draining A Vaporizer Which Incorporates A Keyed Filler................... |
10 |
Fig.10 |
Filling A Vaporizer Which Incorporates A Quik-Fil™ .................Filler |
11 |
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Fig.11 |
Draining A Vaporizer Which Incorporates A Quik-Fil™ .............Filler |
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Fig.12 |
Vaporizer Interlock Mechanism........................................................... |
15 |
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Fig.13 |
Two Vaporizers Locked On To The Manifold - |
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Both Turned OFF................................................................................... |
16 |
Fig.14 |
Two Vaporizers Locked On To The Manifold - |
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Vaporizer A Turned ON........................................................................ |
16 |
Fig.15 |
Manifold By-pass Circuit...................................................................... |
17 |
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Fig.16 |
Vaporizers Flow - Schematic Diagram................................................ |
19 |
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Fig.17 |
Tec 5 Vaporizer Gas Flow..................................................................... |
20 |
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Contents 2 |
Tec 5 Vaporizer |
August 1999 |
O & M Manual Part No. 1105-0100-000 |
1.0Introduction
1.1Operation And Maintenance Manual
This Operation And Maintenance (O&M) Manual contains the information required in order to install, operate and maintain the Tec 5 Continuous Flow Vaporizer.
Requests for servicing facilities, advice or assistance must be addressed either to a local Datex-Ohmeda Field Operations Unit or to an Datex-Ohmeda Authorised Distributor.
Additional copies of this manual, quoting Tec 5 Continuous Flow Vaporizer O & M Manual Part No. 1105-0100-000, can be requested from a local Datex-Ohmeda Field Operations Unit or from an DatexOhmeda Authorised Distributor.
It is recommended that all relevant documentation, including the O & M Manual and accompanying labels and/or inserts, is immediately available to all prospective operators.
1.2Precautions
A number of Warnings and Cautions are used throughout this manual to draw attention to the possible hazards and/or adverse conditions which may occur if the information and instructions provided are not strictly observed.
Cautions and Warnings are preceded bywa symbol and are used to draw attention to a condition which can endanger either the patient or the operator and can result in damage to the equipment.
Special attention must be paid to each Warning and Caution as it appears in the manual.
1.3Symbols
Systems with this mark agree with the European Council Directive (93/42/EEC) for Medical Devices when they are used as specified in their operation and maintenance manuals. The xxxx is the certification number of the Notified Body used by Datex-Ohmeda's Quality Systems.
European Union Representative
Tec 5 Vaporizer |
Page 1 |
O & M Manual Part No. 1105-0100-000 |
August 1999 |
2.0Servicing Policy
During initial installation of a Tec 5 vaporizer, the Next Service Date label located on the vaporizer dial must be completed by the Technician/Engineer/Customer responsible for the installation.
Datex-Ohmeda recommends that all Tec 5 Vaporizers are serviced every three years, irrespective of conditions of use.
Servicing procedures for this Product must be performed by Datex-Ohmeda trained personnel in accordance with written instructions provided by Datex-Ohmeda.
wWarning: Only Technicians/Engineers trained and certificated by Datex-Ohmeda to repair and/or service the Tec 5 Vaporizer should attempt to repair and/or service it and it must be repaired and/or serviced at an Datex-Ohmeda Authorised Service Centre in accordance with written instructions provided by Datex-Ohmeda. Detailed information for more extensive repairs is included in the Tec 5 Vaporizer Service Centre Manual which is available only to Authorised Service Centres.
Warranty repair and service procedures must be performed at an Datex-Ohmeda Authorised Service Centre. A Datex-Ohmeda Service Representative can be contacted at the nearest Datex-Ohmeda Field Operations Unit or Datex-Ohmeda Authorised Distributor.
Do not use malfunctioning equipment. If any assistance is required, contact the nearest Datex-Ohmeda Field Operations Unit or Datex-Ohmeda Authorised Distributor.
If the equipment is to be transported to the nearest Datex-Ohmeda Field Operations Unit, drain the vaporizer, package it securely for protection in its original packaging and ship it prepaid. Enclose the following items as applicable:
1.A letter describing in detail any difficulties experienced with the equipment.
2.Warranty information, such as a copy of the invoice or other applicable documentation.
3.Purchase order number to cover repair of equipment not under warranty.
4.Ship to and bill to information.
5.The name and telephone number of the person to contact.
Page 2 |
Tec 5 Vaporizer |
August 1999 |
O & M Manual Part No. 1105-0100-000 |
3.0Description
3.1General
wWarning: This manual and all its associated documentation must be studied thoroughly before any attempt is made to install, operate or maintain any part of the Tec 5 Vaporizer.
The Tec 5 Vaporizer is designed for out of circuit use in continuous flow techniques of inhalation anaesthesia.
The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures as described in Section 7.2 Effect of Variables.
Each vaporizer is agent specific and is clearly labelled with the name of the anaesthetic agent for which it is designed.
The vaporizer is designed to be used on Selectatec Series Mounted Manifolds. The vaporizer can be installed on other Selectatec Manifolds but the interlock system is designed to function on Selectatec Series Mounted Manifolds only.
Mounting a Tec 5 vaporizer on a Selectatec 7 Compatibility Block is not recommended.
"It is a requirement of European Standard prEN 740 - Anaesthetic Workstations And Their Modules, that an appropriate gas monitor is used to monitor the concentration of anaesthetic agent vapour in the inspiratory gas when the vaporizer is in operation, in order to provide protection against hazardous output in the event of a device malfunction".
wWarning: If the vaporizer has been inverted, connect it to a gas scavenging system, set the dial to 5% and purge the vaporizer with the carrier gas at 5 litres/minute for 5 minutes.
wCaution: Although the vaporizer incorporates an integral non-spill system, the vaporizer is intended to be operated in its upright position.
wCaution: Turn the Vaporizer OFF when it is not in use.
3.2Control Dial
A single control dial with a concentration scale calibrated in percentage of anaesthetic agent vapour per total volume (% v/v) is employed to set the desired concentration of the anaesthetic agent.
A dial release is incorporated in the dial assembly to prevent accidental displacement of the control dial from the OFF position. To select an ON setting it is necessary to pull in the dial release and simultaneously rotate the dial counter-clockwise.
The dial and dial release are designed to enable an ON setting to be selected using only one hand.
3.3Safety Interlocks
The vaporizer incorporates an interlock mechanism. This mechanism also interfaces with the Selectatec Series Mounted Manifold to comprise an interlock system which is designed to help ensure that the following criteria are satisfied:
1.The vaporizer must be locked on to the manifold before it can be turned ON.
2.Only one vaporizer at a time can be turned ON when two or more Tec 4, Tec 5 or Tec 6 vaporizers are fitted on a Selectatec Series Mounted Manifold.
3.The gas flow enters only the vaporizer which is turned ON.
4.Any unwanted anaesthetic trace vapour is minimised after a vaporizer is turned OFF.
Tec 5 Vaporizer |
Page 3 |
O & M Manual Part No. 1105-0100-000 |
August 1999 |
wWarning: Earlier versions of the Selectatec Series Mounted Manifold which provide mounting positions for three vaporizers require that if only two vaporizers are fitted then the centre position must be occupied. If the centre position is not occupied the interlock which helps to ensure that only one vaporizer at a time can be turned ON is ineffective.
Later versions of the Selectatec Series Mounted Manifold which provide mounting positions for three vaporizers incorporate an additional interlock which helps to ensure that only one vaporizer at a time can be turned ON even if the centre position is not occupied.
3.4Vaporizer Identification Label
A vaporizer identification label is affixed to the back panel of the vaporizer as illustrated on Fig. 1.
An anaesthesia system fitted with a vaporizer identification unit uses this label to identify the vaporizer type.
Do not affix any additional labels or markings to the back panel, they may adversely affect the operation of the vaporizer identification unit.
AA.13.051
VAPORIZER
NAME TEC 5
IDENTIFICATION CODE
TEC 5 
AGENT NAME
SEVOFLURANE 
VAPORIZER
IDENTIFICATION
LABEL
Fig. 1 Vaporizer Identification Label
4.0Operating Instructions
4.1General
The vaporizer is designed to be used on Selectatec Series Mounted Manifolds. The vaporizer can be installed on other Selectatec Manifolds but the interlock system is designed to function on Selectatec Series Mounted Manifolds only.
Mounting a Tec 5 vaporizer on a Selectatec 7 Compatibility Block is not recommended.
wWarning: It is a requirement of European Standard prEN 740 - Anaesthetic Workstations And Their Modules, that the gas monitoring device referred to at 3.1 of this manual is in operating condition, by being enabled and functioning , prior to use of the vaporizer.
wWarning: Handle the vaporizer with care at all times. Do not lift or support the vaporizer by holding the control dial.
wWarning: Before mounting a vaporizer on to the manifold ensure that only one 'O' ring is fitted to each manifold port valve. Ensure that each 'O' ring is intact and that there is no foreign matter around the mating surfaces. A damaged 'O' ring and/or foreign matter around the mating surfaces can cause leaks.
wWarning: Do not use a vaporizer if the liquid level decreases to below the minimum level.
wWarning: Before using a vaporizer allow it to attain the ambient temperature of the location in which it is to be used.
Page 4 |
Tec 5 Vaporizer |
August 1999 |
O & M Manual Part No. 1105-0100-000 |
4.2Vaporizer Mounting Procedure
1.Remove the red coloured dust caps fitted to the vaporizer interlock block ports, illustrated on Fig. 2.
2.Check that each port valve 'O' ring is intact and not damaged. Renew each 'O' ring if necessary.
3.Make sure that the vaporizer control dial is in the OFF position.
4.Make sure that the vaporizer locking lever is at the unlocked position, that is, in the up position.
CHECK DIAL IS AT OFF |
CHECK LOCKING LEVER IS UNLOCKED (UP)
CHECK INTERLOCK BLOCK PORTS ENGAGE CORRECTLY WITH MANIFOLD PORT VALVES
REMOVE DUST CAPS FROM INTERLOCK BLOCK PORTS
CHECK EACH MANIFOLD PORT VALVE 'O' RING. FIT NEW 'O' RING(S) IF NECESSARY
AA.13.052
Fig. 2 Vaporizer Mounting Procedure
5.Carefully lower the vaporizer on to the manifold so that the vaporizer interlock block covers the two manifold port valves with the interlock block ports correctly engaged with the manifold port valves.
wCaution: Push the locking lever down to the full extent of its travel before attempting to turn it. The mechanism may be damaged if an attempt is made to turn the lever before it is at the full extent of its vertical travel.
6.Press down the locking lever1 to the full extent of its travel and then turn it clockwise2 to the locked position3 to lock the vaporizer on to the manifold as illustrated on Fig. 3.
PUSH DOWN |
1 |
TO FULL EXTENT |
|
|
2 TURN |
LOCKING LOCKING 
LEVER LEVER
DIAL |
DIAL |
RELEASE |
RELEASE |
3 LOCKED AA.13.053 
Fig. 3 Locking The Vaporizer On To A Manifold
Tec 5 Vaporizer |
Page 5 |
O & M Manual Part No. 1105-0100-000 |
August 1999 |
4.3Checking For Correct Mounting Of The Vaporizer
wWarning: To help to ensure correct operation, do not use a vaporizer which is visibly out of line on the manifold or which can be lifted off the manifold when the locking lever is in the locked position.
1.If more than one vaporizer is fitted, visually check to make sure that the tops of vaporizers are square to the manifold. If a vaporizer is visibly out of line, remove it from the manifold and attempt to mount it correctly. Do not use a vaporizer which cannot be mounted correctly.
2.When the vaporizers appear to be level and their locking levers are in the locked position, attempt to lift each vaporizer from the manifold.
3.If a vaporizer can be lifted OFF the manifold, remove it from the manifold and attempt to mount it correctly. Do not use a vaporizer which cannot be mounted correctly.
4.Make sure only one vaporizer at a time can be turned ON, thus checking that the interlock rods are in alignment.
5.Check the anaesthesia system for leaks in accordance with the relevant O&M Manual with the vaporizer dial turned to 0% and then repeat the check with the vaporizer dial turned OFF.
4.4Turning ON The Vaporizer
Note: Do not attempt to turn the dial if the vaporizer is not properly locked on to the manifold.
1.Pull in the dial release illustrated on Fig. 4 and rotate the dial counter-clockwise. Note that it is not possible to turn ON the vaporizer if an adjacent Tec 4, Tec 5 or Tec 6 vaporizer is turned ON.
AA.13.054
2.The vaporizer should not be used between OFF and the first graduation mark. To avoid inadvertent delivery of small concentrations the control dial should be turned OFF when the vaporizer is not in use.
Fig. 4 Turning ON The Vaporizer
4.5Vaporizer Removal
1.Rotate the dial clockwise to turn OFF the vaporizer. If it is not completely turned to the OFF position it cannot be released from the manifold.
2.Referring to Fig. 5, unlock the vaporizer from the manifold by turning the locking1levercounterclockwise to the unlocked position. Release the locking lever2, check that the locking lever springs up to the unlocked condition3 and then carefully lift the vaporizer straight up and off the manifold.
LOCKING |
2 RELEASE |
3 UNLOCKED |
LEVER |
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LOCKING |
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LEVER |
1 TURN |
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AA.13.053 |
Fig. 5 Unlocking The Vaporizer From A Manifold
Page 6 |
Tec 5 Vaporizer |
August 1999 |
O & M Manual Part No. 1105-0100-000 |
4.6Filling And Draining
4.6.1General
wWarning: Do not fill the vaporizer with any agent other than the agent specified on the front label. The vaporizer is designed for that agent only. Filling the vaporizer with any agent other than that specified can prove to be dangerous to a patient.
wWarning: Do not fill the vaporizer unless the control dial is in the OFF position.
wWarning: Do not turn the dial ON during filling or attempt to fill beyond the ´ mark.
wWarning: Do not drain the agent into any container other than a properly marked drug container.
wWarning: Ensure that the filler cap is tightened prior to use.
Periodically check the agent level. The vaporizer should be refilled at appropriate intervals. The vaporizer is designed to function according to specification as long as there is agent visible above the 
mark.
The vaporizer must be filled and used in an upright position. Small deviations from the upright position do not affect either the output or the safety of the vaporizer, but because the agent depth is shallow in relation to the diameter of the vaporizing chamber, more frequent checks of the agent level should be performed to avoid a misleading impression of the amount of agent in the vaporizer when small deviations from the upright position occur.
At intervals, ideally not exceeding two weeks, the vaporizer should be drained into the correct drug bottle when the agent is low. This helps to preserve the drug purity by removing oxidized impurities, accumulated contaminants and stabilisers. Discard the agent in a manner consistent with local policies and guidelines. Less frequent intervals may be used when the anaesthetic agent does not contain additives or stabilising agents.
4.6.2Filling A Vaporizer Which Incorporates A Screw Cap Filler
wWarning: Before filling a vaporizer fitted with a screw cap filler, turn the cap slowly to allow any pressure to vent slowly.
1. Turn the vaporizer dial clockwise to the OFF position.
FILLER CAP
HEXAGON
AA.13.024
SIGHT GLASS
DRAIN PLUG
Fig. 6 Filling A Vaporizer Which Incorporates A Screw Cap Filler
Tec 5 Vaporizer |
Page 7 |
O & M Manual Part No. 1105-0100-000 |
August 1999 |
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