Datex-Ohmeda Tec 6 Plus User manual

Tec 6 Plus Vaporizer
Operation and Maintenance Manual
U
ibilit
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ser Respons
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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 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 Datex­Ohmeda 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 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 restriction 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; “C” = 1999, “D” = 2000, “E” = 2001, etc. “I” and “O” are not used.
1107-0641-000 2/26/01
1
Introduction
In this section
What this manual includes ..............................................................1-2
Precautions...............................................................................1-3
Symbols ..........................................................................................1-4
1107-0641-000 2/16/01 1-1
Tec 6 Plus Vaporizer
What this manual includes
Important
This manual contains the information required to install, operate and maintain both the Datex-Ohmeda and the North American Dräger vari­ants of the Tec 6 Plus Vaporizer. All of the graphics illustrated in this manual show the Datex-Ohmeda variant, unless the procedure differs for the North American Dräger variant.
Section 1 tells you how to use this manual and supplies information
about the symbols used on the equipment.
Section 2 provides functional descriptions and theory of operation for
the major components.
Section 3 describes all the controls and indicators on the vaporizer. Section 4 tells you how to mount the vaporizer on a manifold. Section 5 provides operating instructions, including a preoperative
checkout and instructions for filling the vaporizer.
Section 6 provides maintenance instructions, including cleaning the
vaporizer and a list of spare parts. Maintenance procedures are re­stricted to those detailed in this manual.
Section 7 provides the theory of operation for the alarm and indicator
display and vaporizer delivery system.
Section 8 provides information for troubleshooting the vaporizer. Section 9 contains specifications for the vaporizer. Section 10 contains the warranty. Section 11 contains Datex-Ohmeda’s servicing policy.
Requests for servicing facilities, advice or assistance must be ad­dressed either to a local Datex-Ohmeda office or to a Datex-Ohmeda Authorized Distributor.
Datex-Ohmeda strongly recommends that you keep all relevant docu­mentation, including this manual and accompanying labels, immedi­ately available to all users.
1-2 2/16/01 1107-0641-000
Introduction
Precautions
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WARNING Do not fill the vaporizer with any substance other than
Suprane™ (desflurane) as specified on the front label. If any substance other than Suprane™ (desflurane) is used, patient injury could occur.
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.
Before using the Tec 6 Plus Vaporizer, you must be familiar with the Suprane™ (desflurane) package insert. Failure to conform to the recommendations on the insert can result in patient injury.
Important:
Do not attempt to use a vaporizer that has been dropped. A dropped vaporizer MUST be sent to the nearest Datex­Ohmeda Field Operations Unit for servicing. See Section 11 for complete shipping instructions.
Do not use malfunctioning equipment. Make all necessary repairs or have the equipment serviced by an authorized Datex-Ohmeda service center. After repair, test the equipment to ensure that it is functioning properly, in accordance with the manufacturer’s published specifications.
European Standard EN 740 -
ules
requires that an appropriate gas monitor is used to monitor the concentration of anesthetic agent vapor 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.
Datex-Ohmeda strongly recommends the use of anesthesia gas mon­itoring with this equipment. Refer to local standards for mandatory monitoring.
Anesthetic Workstations and Their Mod-
1107-0641-000 2/26/01 1-3
Tec 6 Plus Vaporizer
Symbols
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WARNING Warnings tell about a condition that can cause injury to the
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CAUTION Cautions tell about a condition that can cause damage to
Symbol Location Meaning
Warnings and Cautions tell you about dangerous conditions that can occur if you do not follow all instructions in this manual.
operator or the patient.
the equipment. Read and follow all warnings and cautions.
Control Dial Standby setting
Interlock Block Setting mark - dial marking alignment point for required setting
Interlock Block Equi-potential stud - connection for minimizing electrical potential difference
Front Panel Auditory alarm mute button
Display Panel 240 ml refill mark - indicates that an additional 240 ml of agent can be added
Display Panel Symbolizes nominal agent level display when 390 ml of agent in sump (max.)
Display Panel Symbolizes agent level display when 60 ml or more of agent in sump (min.)
Rear Label
Rear Label The degree of protection against electric shock is Type B
Top Plate Label Direction of flow
Various Warning
Various Caution
AC electrical supply must be single phase sinusoidal alternating current. The voltage requirement for the vaporizer appears on this label.
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.
1-4 2/16/01 1107-0641-000
1Description
In this section
What is a Tec 6 Plus Vaporizer?.....................................................2-2
Components....................................................................................2-6
Power supply unit .....................................................................2-6
Filler assembly..........................................................................2-6
Drain plug .................................................................................2-7
Power cord and battery.............................................................2-7
Equi-potential stud....................................................................2-8
Sump ........................................................................................2-8
Heater elements .......................................................................2-8
Sensors.....................................................................................2-8
Agent level sensor....................................................................2-9
Tilt switch..................................................................................2-9
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Tec 6 Plus Vaporizer
What is a Tec 6 Plus Vaporizer?
The Tec 6 Plus Vaporizer adds Suprane™ (desflurane) inhalant anes­thetic vapor to the medical gasses supplied to a patient. The Datex­Ohmeda vaporizer should be used in anesthesia systems equipped with a Selectatec
The North American Dräger vaporizer should be used in anesthesia systems equipped with an exclusion manifold. Both variants of the Tec 6 Plus Vaporizer must be supplied with dry medical gas and be con­nected to a suitable AC power supply.
The Tec 6 Plus Vaporizer is designed to meet UL 2601-1, EN 60601­1 and IEC 601-2-13.
®
Series Manifold only.
Warning
• Keep upright at all times.
• Do not autoclave.
• Not for use in the prescence of flammable anaesthetic agents.
• Only to be used in conlunction with an O monitor.
Warning
• Keep upright at all times.
• Do not autoclave.
Lock
before
use
• Not for use in the prescence of flammable anaesthetic agents.
• Only to be used in conlunction with an O monitor.
See manual for
• Operational Instructions.
• Factors affecting performance.
• Service and maintenance recommendations.
18
16
14
12
Next service date
10
8
7
6
5
1
4
23
Warning
High vaporizer settings with low gas flows may
lead to hypoxic mixtures within the breathing
circuit. Ohmeda strongly recommends the use of
oxygen monitoring.
Refer to manual before use.
Calibrated for use at flows of 0.2 to 10 L/min. and
at ambient temperatures of 18C to 30C at 1013mb.
Tec 6 Plus
USE ONLY DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM UP
ALARM BATTERY LOW
Use only Desflurane
See manual for
• Operational Instructions.
• Factors affecting performance.
• Service and maintenance recommendations.
18
16
14
12
10
Next service date
8
7
6
5
1
4
23
Warning
High vaporizer settings with low gas flows may
lead to hypoxic mixtures within the breathing
circuit. Ohmeda strongly recommends the use of
oxygen monitoring.
Refer to manual before use.
Calibrated for use at flows of 0.2 to 10 L/min. and
at ambient temperatures of 18C to 30C at 1013mb.
Tec 6 Plus
USE ONLY DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM–UP
ALARM BATTERY LOW
Use only Desflurane
Figure 1-1 • Tec 6 Plus Vaporizer, Datex-Ohmeda variant (left), and North American Dräger variant (right)
2-2 2/16/01 1107-0641-000
Description
Mechanical and electrical interlocks incorporated into the vaporizer help to ensure that:
The vaporizer dial can only be turned from n (Standby) when the vaporizer is locked onto the manifold and the green OPERATIONAL light is illuminated to indicate that the vaporizer has attained the correct operating temperature.
Only one vaporizer can be operated at a time.
The gas flow only enters the selected vaporizer.
Unwanted anesthetic trace vapor is minimized after the vaporizer is turned to n (Standby).
Important:
European Standard EN 740 -
ules
requires that an appropriate gas monitor is used to monitor the concentration of anesthetic agent vapor 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.
Datex-Ohmeda strongly recommends the use of anesthesia gas mon­itoring with this equipment. Refer to local standards for mandatory monitoring.
Anesthetic Workstations and Their Mod-
1107-0641-000 2/16/01 2-3
Tec 6 Plus Vaporizer
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WARNING This manual and its associated documentation must be
studied before any attempt is made to install, operate or clean any part of the Tec 6 Plus Vaporizer.
The performance of the anesthesia machine and vaporizer can be degraded if the machine and vaporizer are mis­matched.
To avoid explosive hazards, flammable anesthetic agents such as Ether and Cyclopropane must not be used in this vaporizer. Only anesthetic agents which comply with the requirements for non-flammable anesthetic agents in the IEC 601-2-13 Standard, particular requirements for the safety of anesthesia machines, are suitable for use in the presence of this vaporizer.
As this vaporizer is not suitable for use with flammable anesthetic agents such as Ether or Cyclopropane, the use of antistatic breathing tubes and face masks is not necessary. The use of antistatic or electrically conductive breathing tubes when utilizing high frequency electric surgery equipment may cause burns and is therefore not recommended in any application of this vaporizer.
The functioning of this vaporizer can be adversely effected by the operation of equipment such as high frequency surgical apparatus or short-wave therapy equipment in the vicinity.
Do not operate the vaporizer other than with dry medical gases.
The Tec 6 Plus Vaporizer must not be used in a Magnetic Resonance Imaging environment.
The functioning of this Tec 6 Plus Vaporizer can be adversely affected by electromagnetic interference exceeding the levels specified in EN 60601-1-2.
This product contains a small quantity of Mercury in the tilt switch mechanism and should be disposed of according to local regulations.
Do not attempt to use a vaporizer that has been dropped. A dropped vaporizer MUST be sent to the nearest Datex­Ohmeda Field Operations Unit for servicing. See Section 11 for complete shipping instructions.
2-4 2/16/01 1107-0641-000
Description
ww
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CAUTION If the vaporizer is not likely to be used for a period of 12
months, remove the battery. Failure to do so can result in damage to the vaporizer. The battery must be placed back into the vaporizer before use.
A 'No Output' alarm could be caused by downstream high frequency ventilation at greater than 60 breaths/min with an airway pressure of 100cm H
O or pulsing the O
2
faster than 1 pulse/sec over a time period of greater than 10 seconds.
flush
2
1107-0641-000 2/16/01 2-5
Tec 6 Plus Vaporizer
Components
Power supply unit
Filler assembly
The Tec 6 Plus Vaporizer operates from a 100 to 120VAC 50/60 Hz or 220 to 240V AC 50/60 Hz electrical supply. A label on the rear panel of the vaporizer states the voltage requirement for the vaporizer.
The integral power supply unit consists of a transformer and an AC to DC converter that provides the 12VDC and 5VDC supplies for the electrical system.
The filler assembly uses an agent specific fitting to ensure that only a Suprane™ (desflurane) specific bottle equipped with a Saf-T-Fill™ valve can be inserted to fill the vaporizer.
FILLER ASSEMBLY
FILLER PORT
FILLER
Figure 1-2 • Filler assembly
2-6 2/16/01 1107-0641-000
Use Only
Desflurane
AA.43.037
Description
Drain plug
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CAUTION Do not remove the drain plug. Draining the vaporizer can
The drain plug is located at the base of the vaporizer (see Figure 2-3).
result in rapid loss of pressure and/or agent, which could lead to injury to the operator. It must only be removed at a Datex-Ohmeda Authorized Service Center.
DRAIN PLUG
Figure 1-3 • Vaporizer base
Power cord and
battery
If the AC power supply fails, a Duracell MN1604 or VARTA Energy 2000 battery incorporated in the base of the vaporizer provides power for the auditory and visual alarms only. The battery must be replaced annually.
POWER CORD
D
ghc hjv mn 623r
DURACELL
DURACELL
DURACELL MN 1604 OR VARTA ENERGY 2000 BATTERY
Figure 1-4 • Power cord and battery
1107-0641-000 2/16/01 2-7
Tec 6 Plus Vaporizer
Equi-potential stud
Sump
The equi-potential stud connected, it minimizes any electrical potential difference between the vaporizer casing and the anesthesia system.
Figure 1-5 • Equi-potential stud
The sump contains the agent and includes the agent filling port, the drain, the heaters and the agent level sensor.
The sump has a total nominal capacity of 390 milliliters (ml) which con­sists of a nominal 330 ml indicated volume and a nominal 60 ml reserve.
Y
is located on the top of the vaporizer. When
EQUI-POTENTIAL STUD
Heater elements
Sensors
Two 100W heater elements, located in the base of the sump, heat the agent to a nominal 39 °C (102 °F) to generate the working pressure.
Two 100W heater elements located in the upper part of the vaporizer help prevent condensation of the anesthetic agent in the vaporizer.
The current supplied to power the heaters alternates between the two heaters in the sump and the two heaters in the upper part of the vapor­izer. This minimizes the current requirement.
While it is connected to the electrical supply, the casing of the vapor­izer is normally warm to the touch.
Internal electro/mechanical sensors monitor and maintain the fresh gas/agent vapor pressure balance and the agent volume.
The internal sensors monitor and display operational status and acti­vate the appropriate alarm indication.
2-8 2/16/01 1107-0641-000
Description
Agent level sensor
Tilt switch
An agent level sensing probe measures the agent level. The power must be on for the agent level sensor to activate. If the sump contains between 60 and 390 ml of agent, the LCD level displays the agent lev­el in the sump. For more information, see section 3, Controls and Indi­cators.
If the vaporizer is tilted for 10 seconds while the dial is on and it is in operational mode and delivering vapor, vapor delivery will be stopped, as indicated by the flashing NO OUTPUT light and auditory alarm.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
AA.43.042
Figure 1-6 • Tilt indicator (NO OUTPUT light)
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Tec 6 Plus Vaporizer
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2-10 2/16/01 1107-0641-000
1Controls and Indicators
In this section
Controls...........................................................................................3-2
Dial and dial release.................................................................3-3
Lock lever .................................................................................3-4
Auditory alarm mute button.......................................................3-4
Auditory and visual indicators...................................................3-5
Alarm priority.............................................................................3-6
Status display..................................................................................3-7
Warm-up...................................................................................3-7
Operational...............................................................................3-8
Agent level display....................................................................3-8
Low agent level.........................................................................3-9
No output................................................................................3-10
Alarm battery low....................................................................3-11
1107-0641-000 2/16/01 3-1
Tec 6 Plus Vaporizer
Controls
LOCK
LEVER
DIAL RELEASE
CONCENTRATION DIAL
Note that only the Datex-Ohmeda vaporizer has the lock lever as shown.
EQUI-POTENTIAL STUD
Warning
• Keep upright at all times.
• Do not autoclave.
Lock
before
use
• Not for use in the prescence of flammable anaesthetic agents.
• Only to be used in conlunction with an O monitor.
See manual for
• Operational Instructions.
• Factors affecting performance.
• Service and maintenance recommendations.
18
16
14
12
10
Next service date
8
7
6
5
1
4
23
Warning
High vaporizer settings with low gas flows may
lead to hypoxic mixtures within the breathing
circuit. Ohmeda strongly recommends the use of
oxygen monitoring.
Refer to manual before use.
Calibrated for use at flows of 0.2 to 10 L/min. and
at ambient temperatures of 18C to 30C at 1013mb.
STANDBY SETTING
BATTERY
COVER
POWER CORD
Tec 6 Plus
AUDITORY ALARM MUTE BUTTON
USE ONLY DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM UP
ALARM BATTERY LOW
Use only
Desflurane
INDICATORS
FILLER PORT CONTROLS
D
POWER CORD
RETAINING PLATE
POWER CORD CHANNEL
Figure 3-1 • Tec 6 Plus Vaporizer controls (Datex-Ohmeda variant shown)
3-2 2/16/01 1107-0641-000
Controls and Indicators
Dial and dial release When the operational light is on, push the dial release and turn the dial
to set the agent concentration. The dial cannot be turned from the (standby) setting as long as the WARM-UP light is on.
Åben
16
14
12
10
9
8
7
6
5
1
4
23
D
Tec 6
Figure 3-2 • Concentration dial
You can select the level of agent concentration from 1% to 18%. The dial is marked at intervals of 1% from 1% to 10% and at intervals of 2% from 10% to 18%.
Use the dial release again to turn the dial from the (standby) setting and to turn the dial from 12% to a higher percent setting. All other set­tings can be made without operating the dial release.
A solenoid interlock mechanism ensures that the dial can be turned from the (standby) setting only when the green OPERATIONAL light is illuminated.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
AA.43.040
Figure 3-3 • Operational light
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Tec 6 Plus Vaporizer
Lock lever Only the Datex-Ohmeda vaporizer has a lock lever. Turn the lever fully
clockwise to lock the vaporizer in position
Figure 3-4 • Lock lever
Auditory alarm mute
button
Push to silence alarms. Hold for three seconds to start the alarm test (speaker sounds and indicators light up).
> 3 sec = Alarm test < 3 sec = Alarm silence
Figure 3-5 • Mute button
3-4 2/16/01 1107-0641-000
Auditory and visual indicators
T
The status of the vaporizer is indicated by both visual and auditory alarms (see
Press the auditory alarm mute button , located above the display panel, to mute an alarm (see
low
).
The LCD agent level display indicates the level of agent. The range is between 60 ml and 390 ml. When the indicator is below the 240 ml refill mark , you can add an additional 240 ml of agent.
AUDITORY ALARM MUTE BUTTON
Status display
).
Agent level display
Controls and Indicators
and
Alarm battery
AA.43.038
GREEN
AMBER/RED
AMBER
AMBER
AMBER
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
Figure 3-6 • Front panel display
390 ml NOMINAL
LCD AGEN LEVEL DISPLAY
240 ml REFILL
MARK
60 ml NOMINAL
1107-0641-000 2/16/01 3-5
Tec 6 Plus Vaporizer
Alarm Priority
The Tec 6 Plus Vaporizer has three distinct alarm priorities. For each priority there is a different set of visual and auditory signals:
Alarm Priority Visual Signal Auditory Signal
High Rapid red flashing
light
Medium Amber flashing light One set of three au-
Low Continuous amber
light
Note:
An internal processor failure may also present an intermittent red No Output LED and alarm tone.
Vap. Condition Low Battery Low Agent No Output
Two sets of five audio beeps every 10 seconds
dio beeps every 25 seconds.
One audio beep only
Dial ON Medium
Priority
Dial ON, Alarm Silence Pressed
Dial turned to
Low Priority Audio
Low Priority Low Priority
Figure 3-7 • Alarm priorities
Medium Priority
silenced for 120 seconds, then audio active
(dial locked until condition corrected)
High Priority
High Priority (pressing Si­lence has no effect)
Low Priority (dial locked until condition corrected)
3-6 2/16/01 1107-0641-000
Status display
Controls and Indicators
If the dial is at when an alarm occurs, the auditory alarm does not repeat.
Warm-up
The amber WARM-UP light is continuously illuminated when the va­porizer is in warm-up mode. The dial cannot be turned from when the vaporizer is warming up.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
AA.43.039
Figure 3-8 • Warm-up
1107-0641-000 2/16/01 3-7
Tec 6 Plus Vaporizer
Operational
Agent level display
The green OPERATIONAL light is continuously illuminated when the vaporizer is in operational mode. The dial can be turned from when the vaporizer is operational.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
AA.43.040
Figure 3-9 • Operational
The LCD agent level display consists of a series of bars that indicate the nominal volume of agent in the vaporizer sump.
The symbol means there is approximately 390 ml of agent in the sump. The symbol means there is 60 ml or more of agent in the sump. No bar displayed means there is 60 ml or less of agent in the sump.
As the sump fills, the first agent level indicating bar appears in the LCD volume display when there is between 60 and 80 ml of agent in the sump. As the level increases, more bars are displayed, as illustrated in Figure 3-9, and as the level decreases, fewer bars are displayed.
When the bars are either level with or below the symbol, the sump can accommodate 240 ml of agent, which is one full bottle. When there are no bars visible, as illustrated in Figure 3-10, the LOW AGENT level alarm is activated (see
Low agent level
).
Note:
The agent level display is calibrated to be most accurate when the vaporizer is in a perfectly level position. Deviations from a level po­sition affect the accuracy of the agent level display and may acti­vate the LOW AGENT level alarm.
3-8 2/16/01 1107-0641-000
Controls and Indicators
Low agent level
This alarm indicates that there is less than 60 ml of agent remaining in the sump and agent should be added.
Pressing mutes the auditory alarm for a period of 120 seconds to allow time to fill the vaporizer to above 60 ml.
If a LOW AGENT condition occurs during normal operation, the alarm is activated but the green OPERATIONAL light remains illuminated.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
AA.43.041
Figure 3-10 • Low agent level
1107-0641-000 2/16/01 3-9
Tec 6 Plus Vaporizer
No output
This alarm indicates that the vaporizer has shut down and is no longer delivering vapor.
The NO OUTPUT alarm is activated if the dial is in the ON position and any one of the following occurs:
The agent level decreases to below 20 ml.
The vaporizer is tilted for more than 10 seconds.
A power failure of longer than 10 seconds duration occurs.
An internal malfunction is detected.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
AA.43.042
Figure 3-11 • No output
If the NO OUTPUT alarm occurs while the vaporizer is in use, the va­porizer dial must be turned to .
This action de-escalates the alarm to a low priority and illuminates the amber light continuously. Either an alternative vaporizer or an alterna­tive method of anesthesia must be used.
If the NO OUTPUT alarm is activated as a result of a power failure and the dial is at when the power supply is restored, the alarm and dis­play test is activated and the vaporizer returns to either the WARM-UP or the OPERATIONAL mode.
If the dial is not at when the power supply is restored, the NO OUT­PUT alarm continues and can only be cancelled by turning the dial to . In this condition, the alarm and display test is not activated and the vaporizer returns to either the WARM-UP or the OPERATIONAL mode.
3-10 2/16/01 1107-0641-000
Controls and Indicators
Alarm battery low
This alarm indicates that the alarm battery voltage is low. A new bat­tery must be installed as soon as practical to support the NO OUTPUT alarm in the event of a subsequent external power failure.
If an ALARM BATTERY LOW condition occurs during normal opera­tion, the alarm is activated but the green OPERATIONAL light remains illuminated.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
AA.43.043
Figure 3-12 • Alarm battery low
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Tec 6 Plus Vaporizer
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1Setup and Mounting
Procedure
In this section Vaporizer setup procedure..............................................................4-2
Installing the battery and the power cord..................................4-2
Vaporizer mounting Procedure .......................................................4-5
Mounting the Datex-Ohmeda vaporizer....................................4-6
Checking the vaporizer for correct mounting ................................4-10
Removing the vaporizer from a manifold ......................................4-11
1107-0641-000 2/16/01 4-1
Tec 6 Plus Vaporizer
Vaporizer setup procedure
wwwwWARNING The battery terminals must be firmly clipped onto the
battery to help prevent a possible disconnection when the vaporizer is moved.
Use only a Datex-Ohmeda power cord to connect the vaporizer to the electrical supply.
When routing the power cord to the electrical supply, ensure that it does not interfere with the correct functioning of other equipment.
wwwwCAUTION Do not support the vaporizer by holding the control dial
and/or locking lever. Hold the main body of the vaporizer with both hands and keep the vaporizer in an upright position. Failure to do so may cause the vaporizer to malfunction.
Installing the battery
and the power cord
Step 1
Remove the battery cover.
Invert the vaporizer.
Unscrew the battery cover securing screw.
Remove the battery cover.
Install only a Duracell MN1604 or VARTA Energy 2000 nine volt battery in the vaporizer. If any other battery is installed, it can damage the vaporizer.
A new battery and the power cord supplied with the vaporizer must be fitted during initial installation if they are not already installed.
BATTERY COVER SECURING SCREW
VAPORIZER
DURACELL
INVERTED
Figure 1-1 • Removing the battery cover
4-2 2/16/01 1107-0641-000
Setup and Mounting Procedure
Step 2
Install the battery.
Clip the battery terminals firmly onto the new battery, observing the correct polarity.
Insert the battery into the vaporizer.
Step 3
Fit the battery cover to the base of the vaporizer and tighten the securing screw.
BATTERY TERMINALS
BATTERY COVER SECURING SCREW
DURACELL
DURACELL
mn 623r ghc hjv
Figure 1-2 • Installing the battery
DURACELL
DURACELL
DURACELL
mn 623r ghc hjv
DURACELL MN 1604 OR VARTA ENERGY 2000 BATTERY
Figure 1-3 • Replacing the battery cover
1107-0641-000 2/16/01 4-3
Tec 6 Plus Vaporizer
Step 4
Install the power cord.
Remove the power cord retaining plate.
Fit the power cord firmly into the socket of the vaporizer.
Feed the power cord into the power cord channel.
Clip the power cord retaining plate back into the base.
On the North American Dräger vaporizer, feed the lead around the back of the vaporizer and secure the lead by means of the ’P’ clip.
POWER CORD
D
POWER CORD CHANNEL
POWER CORD RETAINING PLATE
Figure 1-4 • Installing the Datex-Ohmeda power cord
‘P’ CLIP
POWER CORD RETAINING PLATE
POWER CORD
POWER CORD CHANNEL
Figure 1-5 • Installing the North American Dräger power cord
4-4 2/16/01 1107-0641-000
Vaporizer mounting Procedure
wwwwWARNING The Tec 6 Plus vaporizer for North American Dräger
(NAD) must be installed on a NAD anesthesia machine equipped with an exclusion manifold. The installation must be performed by an individual trained in the servicing of NAD anesthesia equipment. Each vaporizer is supplied with O-rings and screws for the service person to install the vaporizer onto the manifold.
Do not mount the vaporizer downstream of the common gas outlet. Mounting the vaporizer in any position other than that recommended in this manual can cause patient injury.
Do not connect any vaporizer other than a Tec 6 Plus, Tec 6, Tec 5, or Tec 4 onto a Selectatec™ Series Manifold. Connecting any other vaporizer onto the manifold may make the interlock system ineffective and can result in the ability to administer anesthetic agent mixtures, possibly causing patient injury.
Setup and Mounting Procedure
Before mounting a vaporizer onto the Selectatec™ Series manifold, ensure that each manifold port valve 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.
Some versions of the Selectatec™ Series Mounted Manifold provide mounting positions for three vaporizers. These versions require the center position to be occupied even if only two vaporizers are fitted. If the center position is not occupied, the interlock which helps to ensure that only one vaporizer at a time can be turned on is ineffective.
1107-0641-000 2/16/01 4-5
Tec 6 Plus Vaporizer
Mounting the Datex-
Ohmeda vaporizer
Step 1
Set the dial to .
Step 2
Later versions of the Selectatec™ Series Mounted Manifold that pro­vide mounting positions for three vaporizers incorporate an additional interlock which ensures that only one vaporizer at a time can be turned on even if the center position is not occupied.
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Figure 1-6 • Setting the concentration dial
Unlock the locking lever.
Turn the lever counterclockwise.
Make sure the lever releases.
Figure 1-7 • Unlocking the locking lever
4-6 2/16/01 1107-0641-000
Step 3
Ready the manifold.
Remove any plugs fitted to the vaporizer interlock block ports.
Verify that each manifold port valve O-ring is intact. If necessary, remove the existing O-rings and fit one new O-ring to each port valve, as described in the relevant anesthesia system O & M Manual. Replacement O-rings are supplied with each vaporizer.
VAPORIZER INTERLOCK BLOCK PORT - ENSURE PLUGS REMOVED
RENEW MANIFOLD PORT VALVE O-RING, IF NECESSARY
Setup and Mounting Procedure
VAPORIZER INTERLOCK BLOCK PORT - ENSURE PLUGS REMOVED
RENEW MANIFOLD PORT VALVE O-RING, IF NECESSARY
wwwwCAUTION To ease the routing of the power cord, the Tec 6 Plus
Step 4
Install the vaporizer into the manifold.
Hold the main body of the vaporizer in an upright position with both hands.
Lower the vaporizer onto the manifold, ensuring that the vaporizer interlock block ports engage correctly with the manifold port valves.
Figure 1-8 • Readying the manifold
Vaporizer must be mounted onto the far right-hand side of the manifold for Excel and Modulus machines. For other machines, refer to their manuals.
Warning
• Keep upright at all times.
• Do not autoclave.
• Not for use in the prescence of
Lock
flammable anaesthetic agents.
• Only to be used in conlunction
before
with an O monitor.
use
See manual for
• Operational Instructions.
• Factors affecting performance.
• Service and maintenance recommendations.
Next service date
18 16
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8
7
6
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Warning
High vaporizer settings with low gas flows may
lead to hypoxic mixtures within the breathing circuit. Ohmeda strongly recommends the use of
oxygen monitoring.
Refer to manual before use.
Calibrated for use at flows of 0.2 to 10 L/min. and at ambient temperatures of 18C to 30C at 1013mb.
Tec 6 Plus
USE ONLY DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM UP
ALARM BATTERY LOW
Use only
Desflurane
Figure 1-9 • Installing the vaporizer
1107-0641-000 2/16/01 4-7
Tec 6 Plus Vaporizer
wwwwCAUTION Push the locking lever down all the way before attempting
Step 5
to turn it. The mechanism can be damaged if an attempt is made to turn the lever before it is at the full extent of its vertical travel.
Lock the vaporizer onto the manifold.
Push the locking lever
down all the way.
Turn it clockwise to the locked position to lock the vaporizer onto the manifold.
PUSH DOWN
TO FULL EXTENT
LOCKING LEVER
LOCKING LEVER
Figure 1-10 • Locking the vaporizer
LOCKED
TURN CLOCKWISE
4-8 2/16/01 1107-0641-000
Step 6
Setup and Mounting Procedure
wwwwWARNING Do not route the power cord over the top of the
Selectatec™ Series manifold. To do so may affect the correct functioning of the Tec 6 Plus Vaporizer and/or any other vaporizer.
Route the power cord.
Route the power cord around the right-hand side of the anesthesia machine as viewed from the front.
* Refer to the Aestiva
manual if mounting vaporizer on an Aestiva.
Step 7
Ensure that the vaporizer is correctly mounted (see
Checking the vaporizer for correct mounting
).
SIDE SUPPORT
POWER CORD ROUTED AROUND THE SIDE SUPPORT AND TO THE REAR OF THE ANESTHESIA MACHINE*
Figure 1-11 • Routing the power cord
Figure 1-12 • Checking the vaporizer mounting
1107-0641-000 2/16/01 4-9
Tec 6 Plus Vaporizer
Checking the vaporizer for correct mounting
wwwwWARNING To help to ensure correct operation, do not use a vaporizer
that is either visibly out of line on the manifold or that can be lifted off the manifold when the locking lever is in the locked position.
If more than one vaporizer is fitted, visually check to make sure that the tops of the vaporizers are horizontal. If the vaporizer is visibly out of line, perform steps 3 and 4 as described in
from a manifold
When the vaporizer appears to be level and the locking lever is in the locked position, attempt to lift the vaporizer straight up from the mani­fold. If the vaporizer can be lifted off the manifold, it is not correctly mounted. Remount the vaporizer (see
dure
).
and remount it correctly.
Removing the vaporizer
Vaporizer mounting Proce-
4-10 2/16/01 1107-0641-000
Setup and Mounting Procedure
Removing the vaporizer from a manifold
wwwwWARNING Only an individual trained in the servicing of NAD
anesthesia equipment can remove a vaporizer from a North American DrŠger (NAD) machine.
This procedure applies only to the Datex-Ohmeda vaporizer.
Step 1
Set the dial to .
Step 2
Disconnect the vaporizer from the AC power supply.
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Figure 1-13 • Setting the dial
1107-0641-000 2/16/01 4-11
Tec 6 Plus Vaporizer
Step 3
Unlock the locking lever.
Turn the locking lever counter-clockwise .
Release the locking lever
and check that the
locking lever springs up to the unlocked position to release the vaporizer from the manifold.
RELEASE
COUNTER-
CLOCKWISE
LOCKING LEVER
TURN
UNLOCKED
LOCKING LEVER
Figure 1-14 • Unlocking the locking lever
DIAL
DIAL
Step 4
Carefully lift the vaporizer up from the manifold.
Warning
• Keep upright at all times.
• Do not autoclave.
• Not for use in the prescence of
Lock
flammable anaesthetic agents.
• Only to be used in conlunction
before
with an O monitor.
use
See manual for
• Operational Instructions.
• Factors affecting performance.
• Service and maintenance recommendations.
Next service date
18
16
14
12
10
8
7
6
5
1
4
23
Warning
High vaporizer settings with low gas flows may
lead to hypoxic mixtures within the breathing
circuit. Ohmeda strongly recommends the use of oxygen monitoring.
Refer to manual before use.
Calibrated for use at flows of 0.2 to 10 L/min. and
at ambient temperatures of 18C to 30C at 1013mb.
Tec 6 Plus
USE ONLY DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM UP
ALARM BATTERY LOW
Use only
Desflurane
Figure 1-15 • Lifting the vaporizer
4-12 2/16/01 1107-0641-000
1Operating Instructions
In this section Alarm and display test.....................................................................5-2
Preoperative checkout. ...................................................................5-5
Setting the dial ..............................................................................5-10
Filling the vaporizer.......................................................................5-13
Filling procedure.....................................................................5-14
1107-0641-000 2/16/01 5-1
Tec 6 Plus Vaporizer
Alarm and display test
wwwwWARNING Only use vaporizers that are in a serviceable condition.
wwwwCAUTION Before connecting the vaporizer to an AC power supply,
be sure it is within the ambient operating temperature range (see
Step 1
Connect the power cord from the vaporizer to an approved hospital grade outlet socket.
Performance
in Chapter 9).
wwwwWARNING Do not use the vaporizer if during the alarm and display
Step 2
Verify that the alarm and display test for a period of approximately four seconds as follows:
Each light and all the LCD agent level indicator bars on the front display panel flash.
The auditory alarm is activated.
test any one of the five lights and all the LCD agent level indicator bars do not flash or the auditory alarm does not operate for a period of approximately four seconds.
DESFLURANE
OPERATIONAL
NO OUTPUT
Flashes
LOW AGENT
WARM-UP
ALARM BATTERY LOW
Figure 1-1 • Verifying the alarm
5-2 2/16/01 1107-0641-000
Step 3
Operating Instructions
If the LOW AGENT light remains illuminated after the alarm and display test is completed, fill the vaporizer as described in
vaporizer
Filling the
.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
Figure 1-2 • Filling the vaporizer
1107-0641-000 2/16/01 5-3
Tec 6 Plus Vaporizer
Step 4
If there is sufficient agent in the sump, check that each light is extinguished, except the amber WARM-UP light which indicates that the vaporizer is in its warm-up condition. If the vaporizer is warm before it is connected to the electrical supply, the green OPERATIONAL light may illuminate immediately.
Step 5
After a warm-up period of up to 10 minutes check that the amber WARM-UP light extinguishes and the green OPERATIONAL light illuminates to indicate that the vaporizer is ready for use.
If the OPERATIONAL light does not illuminate within 10 minutes, refer to the
Troubleshooting guide
Chapter 8.
in
Figure 1-3 • Checking Warm-up light
Approx. ten minutes
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
Figure 1-4 • Checking Operational light
Step 6
The alarm and indicators can be tested at any time by pressing A for at least three seconds to activate the alarm and display test. Activating the
Figure 1-5 • Testing alarm
test does not affect the operation of the vaporizer.
5-4 2/16/01 1107-0641-000
> 3 sec = Alarm test
Preoperative checkout
Step 1
Test the vaporizer for leaks.
The Tec 6 Plus Vaporizer can be positive pressure or negative pressure leak tested.
Perform the leak test as described in the relevant anesthesia system's operation and maintenance manual initially with the dial at n
). Repeat the test with
( the vaporizer dial turned to the 1% setting () and then turn the dial to the n setting ().
Operating Instructions
Leak test
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Leak test
1%
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10
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2
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4
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6
5
7
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Figure 1-6 • Testing for leaks
1107-0641-000 2/16/01 5-5
Tec 6 Plus Vaporizer
Step 2
Check the battery.
Check the amber ALARM BATTERY LOW light.
If the light is illuminated, fit a new battery as described in
Changing the battery
in
Chapter 6.
Check that the light extinguishes.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
Figure 1-7 • Checking the battery
5-6 2/16/01 1107-0641-000
Step 3
Test the vaporizer output alarm.
Turn the dial to a setting of 1% or above.
Unplug the power cord from its outlet socket.
Wait for at least 15 seconds and then check that both the auditory alarm and the red NO OUTPUT light are activated.
If the alarm and light are not activated, do not use the vaporizer.
Operating Instructions
>1%
3
4
5
6
7
8
10
12
18
14
16
D
15 seconds
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
Figure 1-8 • Testing the output alarm
1107-0641-000 2/16/01 5-7
Tec 6 Plus Vaporizer
Step 4
Reconnect power to the vaporizer.
When the alarm and light are activated, turn the dial to the n setting.
Reconnect the power cord.
Check that the alarm and display test is activated.
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D
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
Figure 1-9 • Reconnecting the vaporizer
Flashes
5-8 2/16/01 1107-0641-000
Step 5
Operating Instructions
When the green OPERATIONAL light illuminates, the vaporizer is ready for operation.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
Figure 1-10 • Checking the Operational light
1107-0641-000 2/16/01 5-9
Tec 6 Plus Vaporizer
Setting the dial
wwwwWARNING High percent dial settings combined with low gas flows
may lead to hypoxic mixtures within the breathing circuit. Datex-Ohmeda strongly recommends the use of oxygen monitoring.
Important
The dial release must be operated to turn the dial from the
n setting and also to increase the dial setting to above
12%. Do not operate the dial release when turning the dial to any other setting, it may result in overriding the 12% stop and causing an inadvertent delivery in excess of 12%.
The vaporizer has not been calibrated at any dial setting between settings between
It is a requirement of European Standard EN 740 -
stations And Their Modules
in
What is a Tec 6 Plus Vaporizer?
erating condition, by being enabled and functioning, prior to use of the vaporizer.
An appropriate anesthetic gas monitor must be used to monitor the concentration of anesthetic agent vapor 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.
Datex-Ohmeda strongly recommends the use of anesthesia gas mon­itoring with this equipment. Refer to local standards for mandatory monitoring.
n and 1%. Do not use the vaporizer at dial
n and 1%.
Anaesthetic Work-
, that the gas monitoring device referred to
in Section 2 of this manual is in op-
5-10 2/16/01 1107-0641-000
Step 1
Press the dial release and turn the dial in a counter-clockwise direction from the n setting.
DIAL RELEASE
Operating Instructions
Åben
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Tec 6 Plus
Figure 1-11 • Releasing the dial
D
Step 2
Release the dial release and turn the dial to the required percentage setting.
Step 3
Check that when the vaporizer dial is turned from n, no other vaporizer mounted on the same manifold can be turned on.
Åben
1
23
12
4
10
9
5
8
D
Tec 6 Plus
Figure 1-12 • Dialing the required percentage
1107-0641-000 2/16/01 5-11
Tec 6 Plus Vaporizer
Step 4
Turn the dial to the n setting and check that the dial release springs out.
Åben
The vaporizer will remain in standby n, ready for further use if required, until the electrical supply is disconnected.
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D
Tec 6 Plus
Figure 1-13 • Setting dial to standby
5-12 2/16/01 1107-0641-000
Filling the vaporizer
wwwwWARNING Do not fill the vaporizer with any substance other than
Operating Instructions
Suprane™ (desflurane). If any substance other than Suprane™ (desflurane) is used, patient injury could occur.
When the vaporizer is in use, do not fill the vaporizer if the following conditions apply:
• The dial setting is more than 8% at flows of 8 liters/minute or above.
• The vaporizer is subjected to any high back pressure.
• The Suprane™ (desflurane) has been refrigerated or chilled below 18 °C.
Failure to comply with this warning may result in a temporary decrease in delivered concentration and activate the NO OUTPUT alarm.
Only fill the vaporizer when it is in an upright position. Failure to do so may result in the vaporizer being over filled.
Only fill the vaporizer when it is connected to the electrical supply. This enables you to observe the agent level display. Do not attempt to fill the vaporizer when the level display indicates that it is full.
To avoid explosive hazards, flammable anesthetic agents such as Ether and Cyclopropane must not be used in this vaporizer. Only anesthetic agents which comply with the requirements for non-flammable anesthetic agents in the IEC 601-2-13 Standard,
Safety of Anesthesia Machines
presence of this vaporizer.
Particular Requirements for the
, are suitable for use in the
1107-0641-000 2/16/01 5-13
Tec 6 Plus Vaporizer
As this vaporizer is not suitable for use with flammable anesthetic agents such as Ether or Cyclopropane, the use of antistatic breathing tubes and face masks is not necessary. The use of antistatic or electrically conductive breathing tubes when utilizing high frequency electric surgery equipment may cause burns and is therefore not recommended in any application of this vaporizer.
Filling procedure
Step 1
Remove the bottle cap from the Suprane™ (desflurane) bottle and ensure that the O-ring is correctly fitted to the bottle probe.
When filling the Tec 6 Plus Vaporizer, observe the following:
The vaporizer must only be filled when it is in an upright position.
The vaporizer sump can be filled when the vaporizer is in its WARM-UP cycle or at any time the vaporizer is in use except as noted in the warning. If the vaporizer is in its OPERATIONAL condition, the time taken for the agent to flow into the vaporizer may be increased.
Only agent bottles with a Saf-T-Fill™ bottle probe specific to Suprane™ (desflurane) should be inserted into the filler port.
BOTTLE CAP
'O' RING
Figure 1-14 • Removing the bottle cap
5-14 2/16/01 1107-0641-000
Step 2
Insert the bottle probe into the filler port and then push the bottle firmly against the spring pressure until it is fully engaged in the filler port.
PUSH BOTTLE FIRMLY INTO FILLER PORT
Operating Instructions
DESFLURANE
D
Figure 1-15 • Loading the bottle
ENSURE BOTTLE IS FULLY ENGAGED IN FILLER PORT
wwwwWARNING Ensure that the bottle probe is fully engaged into the filler
Step 3
Lift the bottle upwards. If the bottle cannot easily be
lifted, it may be because the bottle has not been completely inserted.
port before attempting to lift the bottle. If the bottle cannot easily be lifted, do not force it, otherwise the valve can be broken.
Figure 1-16 • Lifting the bottle
1107-0641-000 2/16/01 5-15
Tec 6 Plus Vaporizer
Step 4
Fill the vaporizer.
When the bottle moves easily, lock the bottle in the upper position.
When the bottle reaches the upper stop, the agent bubbles for up to 45 seconds before it flows from the bottle through the filler port into the vaporizer sump.
Hold the bottle in position at the upper stop and fill until the bottle is empty or the indicator on the display panel indicates that the sump is full.
BOTTLE AT UPPER STOP
Figure 1-17 • Filling the vaporizer
5-16 2/16/01 1107-0641-000
wwwwWARNING Grip the bottle firmly while rotating it downwards from the
Step 5
Drain the bottle and remove.
Grip the bottle firmly and lower it from the upper stop position to the lower stop position.
When the bottle reaches the lower stop position, hold the bottle firmly in the filler port for at least five seconds to allow the small amount of agent in the filler system to drain back into the bottle.
To avoid dropping the bottle, support the bottle as it is automatically unlocked from the filler port and released from the filler. Note: Do not twist the bottle as you pull the bottle out
The valve on the bottle automatically closes to help avoid loss of agent.
Operating Instructions
upper stop position to the lower stop position and hold the bottle firmly in the filler port until the small amount of agent in the system has drained back into the bottle. Failure to do so may result in spilling agent.
5 sec
Figure 1-18 • Removing the bottle
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Tec 6 Plus Vaporizer
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5-18 2/16/01 1107-0641-000
1Maintenance
In this section Maintenance intervals .....................................................................6-2
Cleaning..........................................................................................6-2
External cleaning......................................................................6-2
Internal contamination ..............................................................6-3
Output concentration check......................................................6-3
Changing the battery.......................................................................6-4
Spare parts......................................................................................6-7
1107-0641-000 2/16/01 6-1
Tec 6 Plus Vaporizer
User Maintenance
Maintenance
Cleaning
ww
ww
Prior to performing any maintenance procedures or returning to a
Intervals
service center for repairs, clean and disinfect the vaporizer.
Annually: Battery replacement.
Two years from purchase date and every six months thereafter:
Planned safety inspections together with the anesthesia system by qualified personnel.
Inspect and perform Output concentration check.
WARNING Do not put any substance other than Suprane
(desflurane) into the vaporizer sump. Do not immerse the vaporizer in water or any other liquid. Do not autoclave the vaporizer. Do not allow cleaning agents to accumulate in the filler, the
gas inlet and outlet ports or around the control dial.
External cleaning
ww
ww
WARNING To avoid possible damage to the vaporizer, do not use the
To clean external surfaces, use a moist cloth and a detergent (pH 7 to 10.5).
For disinfection purposes, cleaning agents of a surface germicide type should be used. In terms of material compatibility, cleaning agents which contain the following active ingredients are suitable for use:
Aldehydes,
Alcohol,
Quartenary ammonium compounds.
following compounds as cleaning agents:
Halogen hydrolyzing compounds,
Strong organic acids,
Oxygen hydrolyzing compounds.
6-2 3/23/01 1107-0641-000
Maintenance
Internal
contamination
Output concentration
check
If the vaporizer is filled or partly filled with an incorrect volatile agent or other contaminant, proceed as follows:
1. Remove the vaporizer from service immediately and label the va­porizer stating that it is contaminated.
2. Return the vaporizer to the Datex-Ohmeda Authorized Service Center stating that the vaporizer is contaminated and, if possible, the type of contaminant in the vaporizer.
Connect the Tec 6 Plus to Anesthesia Machine.
1. Set the oxygen output of the anesthesia machine to a flow of 5 ±
0.5 L/min.
2. Ensure that the fresh gas output is connected to a gas scavenging system.
3. Measure the concentration at the fresh gas outlet, using an agent monitor which is calibrated to measure desflurane.
4. Allow the readings to stabilize and check that the readings are within specified tolerances.
5. Document and maintain the test results, including the date, person performing the test, and serial number of the unit tested.
The accuracy of the measuring equipment must be considered when obtaining the readings!
Dial Setting Min Vol % Max Vol %
1 .5 1.50
6 5.10 6.90 12 10.20 13.80 18 15.30 20.70
1107-0641-000 2/16/01 6-3
Tec 6 Plus Vaporizer
Changing the battery
Change the battery every 12 months, irrespective of condition.
Step 1
Turn the dial to n
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23
Step 2
Disconnect the power cord from the electrical supply.
Step 3
Remove the battery cover.
Remove the vaporizer from the manifold of the anesthesia system as described in
vaporizer from a manifold
in Chapter 4 and invert the vaporizer.
Unscrew the battery cover securing screw.
Remove the battery cover.
Removing the
BATTERY COVER SECURING SCREW
Figure 6-1 • Setting the dial to standby
DURACELL
DURACELL
DURACELL
mn 623r ghc hjv
VAPORIZER
INVERTED
Figure 6-2 • Removing battery cover
6-4 2/16/01 1107-0641-000
Step 4
Remove the battery and disconnect the terminals.
Dispose of the battery according to local regulations.
wwwwCAUTION Install only a Duracell MN1604 or VARTA Energy 2000
Maintenance
DURACELL
DURACELL
DURACELL
mn 623r ghc hjv
Figure 6-3 • Removing the battery
nine volt battery in the vaporizer. If any other battery is installed, it can damage the vaporizer.
wwwwWARNING The battery terminals must be firmly clipped onto the
Step 5
Install a new battery.
Clip the battery terminals firmly onto the new battery, observing the correct polarity.
Insert the battery into the vaporizer.
battery to help prevent a possible disconnection when the vaporizer is moved.
BATTERY TERMINALS
DURACELL
DURACELL
mn 623r ghc hjv
DURACELL MN 1604 OR VARTA ENERGY 2000 BATTERY
Figure 6-4 • Installing new battery
1107-0641-000 2/16/01 6-5
Tec 6 Plus Vaporizer
Step 6
Fit the battery cover to the base of the vaporizer and tighten the securing screw.
wwwwWARNING Do not throw batteries onto a fire, do not open with force
BATTERY COVER SECURING SCREW
DURACELL
DURACELL
DURACELL
mn 623r ghc hjv
Figure 6-5 • Replacing battery cover
and do not recharge. To do so may result in operator injury. When disposing of batteries, treat them as special waste and dispose of according to local regulations.
6-6 2/16/01 1107-0641-000
Spare parts
Maintenance
Description Part No.
O-ring Kit 1104-3025-000 Battery 1370219 NAD Mounting Kit 1107-7097-000
Power Cords:
Aestiva (universal) .5 m 1006-3796-000 IEC 320 1.5 m 1107-3191-000 North America 3.5 m 1107-3189-000 North America 1.5 m 1107-3190-000 Continental Europe 1.5 m 1007-3186-000 Continental Europe 3.5 m 1107-3185-000 United Kingdom 3.5 m 1107-3187-000 Australia / New Zealand 1.5 m 1107-4020-000 Australia / New Zealand 3.5 m 1107-4025-000
To order contact your Datex-Ohmeda customer service representative.
1107-0641-000 2/16/01 6-7
Tec 6 Plus Vaporizer
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6-8 2/16/01 1107-0641-000
1Principle of Operation
In this section Alarm and indicator display.............................................................7-2
Delivery of gas/agent vapor ............................................................7-2
1107-0641-000 2/16/01 7-1
Tec 6 Plus Vaporizer
Alarm and indicator display
See Figure 7-1.
1. When the electrical supply is connected, each light and each LCD agent level display bar on the front display panel (17) flashes and the auditory alarm activates to indicate that the alarms are opera­tional. After approximately four seconds, each light is extin­guished, the LCD bars stop flashing and the auditory alarm is silenced.
2. The amber WARM-UP light is illuminated to indicate that the va­porizer is in its warm-up cycle and the LCD agent level display bars indicate the amount of agent in the sump.
3. During the warm-up cycle, the shut-off valve (8) is closed to pre­vent the supply of vapor to the pressure regulating valve (7), and the electronics (16) perform the zero check.
4. When the vaporizer attains the required operating temperature, the amber WARM-UP light is extinguished and the green OPER­ATIONAL light illuminates to indicate that the vaporizer is ready for use.
Delivery of gas/agent vapor
1. When the vaporizer is ready for use, a signal from the electronics (16) operates the solenoid (19) in the interlock mechanism which allows the dial and rotary valve (1) to be turned.
2. When the dial and rotary valve (1) are turned, a signal from the electronics (16) opens the shut-off valve (8).
3. The pressure control transducer (3) sends a signal of the differ­ence between the gas inlet pressure and the regulated agent pres­sure to the electronics (16). The electronics alters the regulated agent pressure by opening or closing the pressure regulating valve (7) to balance the pressures.
4. When the regulated agent pressure of the circuit is equal to the gas inlet pressure, the vaporizer functions correctly.
5. The dial and rotary valve (1) regulates the volume of vapor being delivered to the fresh gas mixture.
6. The fresh gas mixes with the vapor just prior to the gas/agent out­let in the proportions consistent with the selected dial setting.
7-2 2/16/01 1107-0641-000
18
Fresh Gas Inlet
20 19
Principle of Operation
1
Gas/Agent Outlet
2
Gas Inlet Pressure
DESFLURANE
Operational
No Output
Low Agent
Warm-Up
Alarm Battery Low
17
15
16
14
3
4
5
Regulated Agent Pressure
6
7
8
9
10
12 1113
KEY
FRESH GAS
AGENT VAPOR
GAS/AGENT VAPOR
ELECTRICAL CONNECTIONS
AA.43.072
KEY TO COMPONENTS
1 DIAL & ROTARY VALVE 2 FIXED RESTRICTOR 3 PRESSURE CONTROL TRANSDUCER 4 PRESSURE MONITOR TRANSDUCER 5 HEATER IN VAPOR CONTROL MANIFOLD 6 VAPOR CONTROL MANIFOLD ASSEMBLY 7 PRESSURE REGULATING VALVE 8 SHUT-OFF VALVE 9 SUMP ASSEMBLY
10 LIQUID AGENT
11 LEVEL SWITCH 12 LEVEL SENSOR 13 SUMP HEATERS 14 MAINS LEAD 15 BATTERY 16 ELECTRONICS 17 FRONT DISPLAY PANEL 18 TILT SWITCH 19 SOLENOID IN THE INTERLOCK BLOCK 20 HEATER IN THE VALVE PLATE
Figure 1-1 • Vaporizer schematic
1107-0641-000 2/16/01 7-3
Tec 6 Plus Vaporizer
This page left blank intentionally.
7-4 2/16/01 1107-0641-000
1Troubleshooting
In this section Troubleshooting guide.....................................................................8-2
1107-0641-000 2/16/01 8-1
Tec 6 Plus Vaporizer
Troubleshooting guide
The following table details the alarm condition and the actions which must be performed to correct the alarm condition and the possible cause.
If vaporizer fails to function correctly after the appropriate action has been taken, send the vaporizer to the Datex-Ohmeda Authorized Ser­vice Center for repair.
Note:
If the dial is at the setting when an alarm occurs, the auditory alarm does not repeat.
Vaporizer Status Action Possible cause
The vaporizer dial release can be
Let go of the dial release, then: depressed, but the dial will not turn. When more pressure on the dial release is applied, a click on the mechanism is detected. The
a) Allow the vaporizer to warm up
until the green OPERA­TIONAL light illuminates.
a) During WARM UP, the
interlock mechanism pre­vents vaporizer use.
dial still cannot be turned.
b) If another vaporizer is in use,
turn the other vaporizer to dial to OFF/ .
b) The interlock mechanism
of another vaporizer is operative.
Alarm indication Action Possible cause
DESFLURANE
Turn the dial to . Restore
external power. The vaporizer
may go to operational or perform
Power failure.
a thorough system check before
OPERATIONAL
going operational, depending on
time of external power restoration,
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
or permanently red alarm if an
internal power failure is detected.
Note that a power failure causes
AA.43.042
the higher pitched audio alarm
tone.
__________________________
Turn the dial to and level the
_______________________ Tilt
vaporizer.
__________________________
wwwwWARNING
_______________________ Any internal malfunction.
Use an alternative means of anesthesia.
8-2 2/16/01 1107-0641-000
Troubleshooting Guide
Alarm indication Action Possible cause
Fill the sump with Suprane™. Agent level <60 ml.
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
DESFLURANE
Turn the dial to and fill the
sump with Suprane™.
wwwwWARNING If the NO
OUTPUT alarm persists, use an alternative means of anesthesia.
AA.43.041 R
Change the battery as soon as
practical (ideally within eight
hours of alarm indication).
wwwwWARNING If this
condition persists until there is less than 20 ml of agent in the sump, the NO OUTPUT alarm is activated and the output ceases.
Agent level <20 ml.
Alarm battery low.
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
AA.43.043
1107-0641-000 2/16/01 8-3
Tec 6 Plus Vaporizer
Alarm indication Action Possible cause
DESFLURANE
OPERATIONAL
NO OUTPUT
LOW AGENT
WARM-UP
ALARM BATTERY LOW
AA.43.039
wwwwWARNING Do not
attempt to use the vaporizer.
If the amber WARM-UP light does not extinguish within ten minutes after the vaporizer is connected to an electrical supply, there may be an internal malfunction.
8-4 2/16/01 1107-0641-000
1Specifications
In this section Calibration.......................................................................................9-2
Electrical supplies ...........................................................................9-2
Performance....................................................................................9-3
Classification...................................................................................9-4
Weight and dimensions...................................................................9-5
Flow characteristics.........................................................................9-6
Effects of output at varied altitudes.................................................9-7
Effects of ambient temperature.......................................................9-7
Effects of back pressure..................................................................9-7
Effects of carrier gas composition...................................................9-8
1107-0641-000 2/16/01 9-1
Tec 6 Plus Vaporizer
Calibration
wwwwWARNING The Tec 6 Plus Vaporizer can only be calibrated at a
Electrical supplies
Note:
All specifications are nominal and subject to change without notice.
Check the calibration certificate that is included with your Tec 6 Plus Vaporizer.
Datex-Ohmeda Authorized Service Center.
The Tec 6 Plus Vaporizer is calibrated at 760 torr and at a nominal 21 °C for the following concentrations (v/v percent): 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16 and 18, using O2 as the carrier gas flowing at five liters/minute.
.
Voltage requirement 100 to 120V AC 50/60 Hz or
220 to 240V AC 50/60 Hz Power consumption 250 VA nominal Current input Maximum current requirement is 2.0 A
The ~ symbol on the vaporizer rating label denotes that the external AC power supply must be single phase sinusoidal alternating current.
9-2 2/16/01 1107-0641-000
Performance
Specifications
Concentration range 1 to 18% Scale 1% from 1 to 10%
2% from 10 to 18% Calibrated flow range
at 21 ± 2 °C Accuracy at 5 liters/
min O
2
Liquid capacity 390 ml nominal volume (indicated on lev el
Flow resistance Less than 50 cm H
Battery Duracell MN 1604 or VARTA Energy 2000 Operating
temperature range Operating humidity
range Storage temperature
range
0.2 to 10 liters/minute
± 0.5% v/v of delivered agent or ± 15%
dial setting (whichever is greater)
display)
240 ml refill capacity indicator
nominal 60 ml reserve (not indicated on
level display)
O at 5 liters/minute of O2 at 21 °C Less than 250 cm H2O at 15 liters/minute of O2 at 21 °C
18 °C to 30 °C (64 °F to 86°F)
30% to 75% relative humidity (non-condensing)
-40 °C to 60 °C (-40 °F to 140°F)
2
Storage relative humidity range
Storage atmospheric pressure
1107-0641-000 2/16/01 9-3
0% to 95% relative humidity at 40 °C (non-condensing)
70.0 to 106.0 kPa
Tec 6 Plus Vaporizer
Classification
The vaporizer can be powered indefinitely unless a fault condition oc­curs, also known as continuous rating.
Type of protection against electric shock is Class 1. Accessible con­ductive parts of Class 1 equipment are connected to a protective earth in such a way that they do not become live in the event of a failure of the basic insulation.
The symbol on the vaporizer rating label denotes the degree of protection against electric shock, which is Type B.
The vaporizer is not protected against liquid flowing into the interior of the unit.
9-4 2/16/01 1107-0641-000
Weight and dimensions
Datex-Ohmeda
Weight 9.5 kg 20 lb 15 oz
Depth 235 mm 9 1/4 inches Width 110 mm 4 3/8 inches Height 250 mm 9 7/8 inches (in
North American Dräger
Weight 10 kg 22 lb (empty)
Specifications
(empty)
the unlocked position)
Depth 235 mm 9 1/4 inches Width 110 mm 4 3/8 inches Height 235 mm 9 1/4 inches
1107-0641-000 2/16/01 9-5
Tec 6 Plus Vaporizer
Flow characteristics
The graph shows the nominal output of the Tec 6 Plus Vaporizer at 760 torr.
19
18
17
16
15
14
13
12
11
10
9
% DESFLURANE OUTPUT
8
7
6
5
4
3
Effect Of Flowrate At 21 deg. C.
18
16
14
12
10
7
5
3
DIAL SETTING %
2
1
012345678910
1
AA.43.058
FLOW (LITERS/MINUTE O2)
9-6 2/16/01 1107-0641-000
Effects of output at varied altitudes
The Tec 6 Plus Vaporizer is calibrated in percent v/v and the calibra­tion is not affected by ambient pressure changes. The partial pressure of the delivered agent at any selected dial setting varies directly with the changes in ambient air pressure. The required dial setting can be calculated using the following formula:
Specifications
Required Dial Setting = Normal Dial Setting % v/v x
The table below shows the dial setting on a Tec 6 Plus Vaporizer at altitudes of 1000m and 2000m respectively above sea level:
Normal dial setting % v/v
5 5.5 6 10 11 12.5 14 17 18
At an altitude of 1000m (3282 feet)
Effects of ambient temperature
The performance of the Tec 6 Plus Vaporizer is not significantly affect­ed by the temperature variations within the operating range specified in
Performance
.
760 torr
ambient pressure (torr)
Required dial setting percent
At an altitude of 2000m (6564 feet)
Effects of back pressure
Fluctuating back pressure does not significantly affect the output of the Tec 6 Plus Vaporizer.
Steady back pressure does not significantly affect the concentration of the agent delivered (v/v), but does increase partial pressure of the agent. The increase is in the ratio of total back pressure to the vapor­izer calibration pressure of 760 torr.
1107-0641-000 2/16/01 9-7
Tec 6 Plus Vaporizer
Effects of carrier gas composition
Small output decreases can occur when the carrier gas composition is changed from 100% oxygen.
When either air or nitrous oxide is employed as the carrier gas, the out­put is lowered compared to the output when oxygen is the carrier gas. This effect is the greatest (up to 20% of setting) at low flows when ni­trous oxide is employed, but using nitrous oxide reduces the required inspired concentrations of volatile agent which can, depending upon the proportion, mitigate the decreases in output from the vaporizer.
9-8 2/16/01 1107-0641-000
1Warranty
In this section Warranty........................................................................................10-2
1107-0641-000 2/16/01 10-1
Tec 6 Plus Vaporizer
Warranty
This product is sold by Datex-Ohmeda under the warranties set forth in the following paragraphs.
Such warranties are extended only with respect to the purchase of this Product directly from Datex-Ohmeda or Datex-Ohmeda’s Authorized Dealers as new merchandise and are extended to the first Buyer thereof, other than for purpose of resale.
For a period of twenty-four (24) months from the date of original deliv­ery to the first Buyer or to Buyer’s order, but in no event for a period of more than two years from the date of original delivery by Datex-Ohm­eda to a Datex-Ohmeda Authorized Dealer, this Product, other than its expendable parts, is warranted against functional defects in materials and workmanship and to conform to the description of the Product contained in the Operation and Maintenance manual and accompany­ing labels and/or inserts, provided that the same is properly operated under conditions of normal use, that regular periodic maintenance and service is performed and that replacements and repairs are made in accordance with the instructions provided. This same warranty is made for a period of thirty (30) days with respect to expendable parts. The foregoing warranties shall not apply if the Product has been re­paired other than by Datex-Ohmeda or other than in accordance with written instructions provided by Datex-Ohmeda, or altered by anyone other than Datex-Ohmeda, or if the Product has been subject to abuse, misuse, negligence, or accident.
Datex-Ohmeda’s sole and exclusive obligation and the Buyer’s sole and exclusive remedy under the above warranty is limited to repairing or replacing, free of charge, at Datex-Ohmeda’s option, a Product which is confirmed as being defective by Datex-Ohmeda following the Buyer's notification to Datex-Ohmeda and, where requested, return of the Product to Datex-Ohmeda in accordance with the instructions con­tained in the Servicing Policy section of the O & M Manual, not later than seven (7) days after the expiration date of the applicable warran­ty. Datex-Ohmeda shall not be otherwise liable for any damages in­cluding but not limited to incidental damages, consequential damages, or special damages.
There are no express or implied warranties which extend beyond the warranties herein above set forth. Datex-Ohmeda makes no warranty of merchantability or fitness for a particular purpose with respect to the Product or parts thereof.
10-2 2/16/01 1107-0641-000
1Servicing Policy
In this section Servicing policy .............................................................................11-2
1107-0641-000 2/16/01 11-1
Tec 6 Plus Vaporizer
Servicing policy
Repairs and service procedures must be performed at a Datex-Ohm­eda Authorized Service Center. Contact your Datex-Ohmeda Service Representative or Datex-Ohmeda Authorized Distributor.
If you are shipping the unit to the nearest Datex-Ohmeda Field Oper­ations Unit, package the vaporizer and power cord securely for protec­tion in its original packaging, and ship it prepaid. Provide the following items:
1. Details of any difficulties experienced with the equipment.
2. Warranty information such as a copy of the invoice or other docu­mentation.
3. Purchase order number to cover repair or service of equipment not under warranty.
4. Ship to and bill to information.
5. The name and telephone number of the person to contact.
11-2 2/16/01 1107-0641-000
Index
A
Accuracy 9-3 Agent concentration 3-3 Agent level display 3-5, 3-8 Agent level indicator 5-2 Agent level sensing probe 2-9 Agent level sensor 2-8, 2-9
LCD 2-9 Alarm and display test 5-2 Alarm and indicators test 5-4 Alarm battery low 3-11 Alarm Levels 3-6 Alarm levels
High 3-6
Low 3-6
Medium 3-6 Ambient operating temperature 5-2 Auditory alarm
No output 2-9
Test 5-2 Auditory alarm mute button 3-4, 3-5 Auditory signals 3-6
C
Calibrated flow range 9-3 Calibration 9-2 Carrier gas composition 9-8 Concentration range 9-3 Concentration, setting 3-3 Condensation 2-8 Current input 9-2 Cyclopropane 2-4, 5-13
D
Datex-Ohmeda Authorized Distributor 11-2 Datex-Ohmeda Field Operations Unit 11-2 Datex-Ohmeda Service Representative 11-2 Depth 9-5 Desflurane 1-3, 2-2, 2-6, 5-13, 5-14
Refrigeration 5-13
Dial 3-3
Setting 5-10 Dial release 3-3, 5-11 Drain plug 2-7
B
Back pressure 9-7 Battery 2-5, 9-3
Changing 6-4 Disposing 6-6 Frequency of replacement 2-7, 6-4 Installing 4-2, 4-3, 6-5 Removing 6-5 Replacement type 4-2, 6-5 Terminals 4-3, 6-5 Testing 5-6
Battery cover
Removing 4-2, 6-4 Securing screw 4-2, 4-3, 6-4, 6-6
Bottle
Lower stop position 5-17 Upper stop position 5-16
Breathing tubes 2-4, 5-14
E
Electrical supplies 9-2 Equi-potential stud 2-8 Ether 2-4, 5-13
F
Face masks 2-4, 5-14 Filler assembly 2-6 Filler port 5-15 Filling the vaporizer 5-14 Flow resistance 9-3 Front panel display 3-5
1107-0641-000 2/16/01 I-1
Index
H
Heater elements 2-8 Height 9-5 High frequency surgical apparatus 2-4 High frequency ventilation 2-5 Hospital grade outlet 5-2
I
Interlock block ports 4-7 Interlocks 2-3, 3-3, 4-5, 4-6
L
Leaks, testing for 5-5 Lights
Alarm battery low 3-5, 5-6 Amber 3-6 Continuous 3-6 Flashing 3-6 Low agent 3-5 No output 2-9, 3-5, 5-7 Operational 3-3, 3-5, 3-8 Red 3-6 Test 5-2
Warm-up 3-5, 3-7 Liquid capacity 9-3 Lock lever 3-4 Locking lever 4-6, 4-8
Locking vaporizer onto manifold 4-8
Unlocking vaporizer from manifold 4-12
Mounting procedure 4-5
N
No output 3-10
O
Operating humidity range 9-3 Operating temperature range 9-3 Output alarm, testing 5-7 Oxygen monitoring 5-10
P
Power consumption 9-2 Power cord 2-7
Installing 4-2, 4-4
Routing 4-2, 4-7, 4-9 Power cord channel 4-4 Power cord retaining plate 4-4 Power failure 3-10 Power supply unit 2-6 Preoperative checkout 5-5 Principle of operation 7-1
Alarm and indicator display 7-2
Delivery of gas/agent vapor 7-2
R
Refill mark 3-5 Removing the vaporizer from a manifold 4-11
M
Magnetic Resonance Imaging 2-4 Manifold 4-7 Manifold port valve O-ring 4-5, 4-7 Manifold port valves 4-7 Mercury, use in Tilt switch 2-4 Monitors
Agent volume 2-8 Pressure balance 2-8
Mounting
Checking for correct mounting 4-10
I-2 1107-0641-000 2/16/01
Index
S
Saf-T-Fill™ 5-14 Saf-T-Fill™ valve 2-6 Scale 9-3 Schematic, vaporizer 7-3 Selectatec™ Series Manifold 2-2, 4-5, 4-6 Sensors 2-1, 2-8 Servicing policy 11-2 Setup procedure 4-2 Short-wave therapy equipment 2-4 Spare parts 6-7 Specifications
Classification 9-4 Effects of ambient temperature 9-7 Effects of back pressure 9-7 Effects of carrier gas composition 9-8 Effects of output at varied altitudes 9-7 Flow characteristics 9-6 Performance 9-3
Weight and dimensions 9-5 Standards 2-2, 2-4, 5-10, 5-13 Status display 3-7 Storage atmospheric pressure 9-3 Storage relative humidity range 9-3 Storage temperature range 9-3 Sump 2-8 Suprane™ 1-3, 2-2, 2-6, 5-13, 5-14
Refrigeration 5-13 Symbols 1-4
V
Vaporizer
Placement in manifold 4-7 Visual signals 3-6 Voltage requirement 9-2
W
Warm-up cycle 5-14 Warm-up mode 3-7 Warranty 10-2 Weight 9-5 Width 9-5
T
Temperature variations 9-7 Tilt switch 2-9 Troubleshooting
Alarm battery low alarm 8-3 Continuous warm-up light 8-4 Low agent alarm 8-3 No output alarm 8-2 No output and low agent alarm 8-3
Troubleshooting guide 8-2
1107-0641-000 2/16/01 I-3
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Printed in USA
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