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.
1107-0641-0002/26/01
1
Introduction
In this section
What this manual includes ..............................................................1-2
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.
1-22/16/01 1107-0641-000
Introduction
Precautions
ww
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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 2/26/011-3
Tec 6 Plus Vaporizer
Symbols
ww
ww
WARNING Warnings tell about a condition that can cause injury to the
ww
ww
CAUTION Cautions tell about a condition that can cause damage to
SymbolLocationMeaning
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 DialStandby setting
Interlock BlockSetting mark - dial marking alignment point for required setting
Interlock BlockEqui-potential stud - connection for minimizing electrical potential difference
Front PanelAuditory alarm mute button
Display Panel240 ml refill mark - indicates that an additional 240 ml of agent can be added
Display PanelSymbolizes nominal agent level display when 390 ml of agent in sump (max.)
Display PanelSymbolizes agent level display when 60 ml or more of agent in sump (min.)
Rear Label
Rear LabelThe degree of protection against electric shock is Type B
Top Plate LabelDirection of flow
VariousWarning
VariousCaution
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.
1-42/16/01 1107-0641-000
1Description
In this section
What is a Tec 6 Plus Vaporizer?.....................................................2-2
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)
2-22/16/01 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 2/16/012-3
Tec 6 Plus Vaporizer
ww
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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.
2-42/16/01 1107-0641-000
Description
ww
ww
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 2/16/012-5
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
2-62/16/01 1107-0641-000
Use Only
Desflurane
AA.43.037
Description
Drain plug
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ww
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
mn623r
DURACELL
DURACELL
DURACELL MN 1604 OR
VARTA ENERGY 2000 BATTERY
Figure 1-4 • Power cord and battery
1107-0641-000 2/16/012-7
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.
2-82/16/01 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.
Dial and dial releaseWhen 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
1107-0641-000 2/16/013-3
Tec 6 Plus Vaporizer
Lock leverOnly 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
3-42/16/01 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 2/16/013-5
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 PriorityVisual SignalAuditory Signal
HighRapid red flashing
light
MediumAmber flashing lightOne set of three au-
LowContinuous amber
light
Note:
An internal processor failure may also present an intermittent red No
Output LED and alarm tone.
Vap. ConditionLow BatteryLow AgentNo Output
Two sets of five
audio beeps every
10 seconds
dio beeps every 25
seconds.
One audio beep
only
Dial ONMedium
Priority
Dial ON,
Alarm Silence
Pressed
Dial turned
to
Low PriorityAudio
Low PriorityLow 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)
3-62/16/01 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 2/16/013-7
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.
3-82/16/01 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.
Pressingmutes 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 2/16/013-9
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.
3-102/16/01 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
1107-0641-000 2/16/013-11
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