GE Tec 6 Plus User manual

GE Healthcare
Tec 6 Plus Vaporizer
Operation
and
Maintenance
Manual

User Hesponsibility
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 Datex-
Ohmeda and by Datex-Ohmeda trained personnel. The Product must not be
altered without the prior written approval of Datex-Ohmeda's Quality Assurance
Department. The user of this Product shall have the sole responsibility for any
malfunction which results from improper use, faulty maintenance, improper
repair, damage, or alteration by anyone other than Datex-Ohmeda.
A Gaution
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
1107-0641-000
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.
0197
1/23/01

Table of Contents
1/Introduction
What this manual includes .Nt 1-2
PrecautionS 이 니이 이 이 아 이 이 아 아 아 마 마 마 아 아 아 아 아 마 아 이 파 마 아 마 아 아 리 아 어 라 아 마 아 아 아 아 아 아 아 아 아 라 아 에 아 어 아 아 아 애 아 아 아 아 아 다 아 에 아 이이 1-3
Symbols.............................................. eee anenanasanasanan 1-4
2/Description
What is a Tec 6 Plus Vaporizer? eee n tn t n 2-2
¡ANS eee eee eeeamenensessana 2-6
Power Supply Unit eee 2-6
Filler ASSEMDIY ...... ie io 2-6
Drain plug (た лини 2-7
Power cord and battey sister 2-7
Equi-potential stud .4 Ett ELERS REESE ELERS ESS E LERNER TE LENE R REELLE E SEES ERR ERE E EELAM ER nn nn er 2-8
SUMP......... iii 2-8
Heater elements ---υ-υ---------ᾱ-υ-----µ., 2-8
Sensols........................................ eee eee eee ener eeananenaeaer ananas anmanın 2-8
Agent level sensor... siennes 2-9
Tilt switch Lu... 이 니 이 이 디 어 어 마 아 아 마 아 마 마 마 애 아 아 아 아 다 여 아 다 아 아 아 아 아 아 더 여 여 아 아 대 아 아 아 아 아 아 아 아 아 아 아 아 아 아 아 아 애 메 다 이 아 에 이 나 이 에 이 니 2-9
3/Controls and Indicators
Controls NNN ONV 3-2
Dial and dial release.… n nenene KA ROKA K KRKA KP REK E PARKER KARR R EKK K P PA nen nen 3-3
LOCK JeVer ee 3-4
Auditory alarm mute ο Πιο μμ iii 3-4
Auditory and visual indicators.….............................. siens 3-5
Alarm Priority .4 3-6
Status display ................ ei 3-7
Warm-Up iii А 3-7
Operational io 3-8
Agent level disDlaY … せ eee ena nA KaK E KKK KKK RR KK REK A PAK A REK ARK K EKORA PARSE EKK P ER Re Renee 3-8
Low agent IA 3-9
A 3-10
Alarm battery low emrenin 3-11
4/Setup and Mounting Procedure
Vaporizer setup procedure 0 e 4-2
Installing the battery and the power cord.................... sn 4-2
Vaporizer mounting Procedure... siennes O nK 4-5
Mounting the Datex-Ohmeda vaporizer eee KRK 4-6
Checking the vaporizer for correct MOUNtINg.................. se 4-10
Removing the Datex-Ohmeda vaporizer from a Manifold .............. iii 4-11
1107-0641-000 3/2/01 i

Tec 6 Plus Vaporizer
5/Operating Instructions
Alarm and IEA iii 5-2
Preoperative checkout. iii 5-5
Setting the dial ...................... iii 5-10
Filing the vaporizer iii 5-13
РИШпа ргоседуге ............... issues 5-14
6/Maintenance
Cleaning... ei eeneneennennese enne 6-2
External cleaning ............... ei 6-2
Internal contamination ............... uo 6-3
Output concentration Check......................... i A AAR ené 6-3
¡AENA eee eeeranansasınnn 6-4
Spare parts eee erenlere eee eamenenenreneneneee aranan 6-7
7/Principle of Operation
Alarm and indicator display... eee 7-2
Delivery of gas/agent vapor issues 7-2
8/Troubleshooting
Troubleshooting Quide issues et 8-2
9/Specifications
Calibraton iii a acerta rene anca sean neo ra ci eanaa res asananena 9-2
Electrical SUpplies ..................... i 9-2
Perormance......................................... eee enamel ann 9-3
Classification esasa eeaan 9-4
Weight and dimensions... ice 9-5
Flow characteristiCS. iii SRE KO KARR A REPRE ne Ke era 9-6
Effects of output at varied altitudes is 9-7
Efectisofambienttemperalure.................................... eee eeneneneenanann 9-7
Effects of back pressure iii a nara nana anca ara saranananaanaa 9-7
Effects of carrier gas composition sien 9-8
10/Warranty
Warranty .............................................. een na 10-2
11/Servicing Policy
Servicing polCY i нина ине a nesse ncesenrererenanns 11-2
Index
ii 38/2101 o 1107-0641-000

In this section
1107-0641-000 1/23/01
What this manual includes
Precautions.................
Symbols...........................
Introduction
1-1

Tec 6 Plus Vaporizer
What this manual includes
Important
1-2
This manual contains the information required to install, operate and
maintain both the Datex-Ohmeda and the North American Drager vari-
ants 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 Drager 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 re-
stricted 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 ad-
dressed either to a local Datex-Ohmeda office or to a Datex-Ohmeda
Authorized Distributor.
Datex-Ohmeda strongly recommends that you keep all relevant docu-
mentation, including this manual and accompanying labels, immedi-
ately available to all users.
1/23/01 1107-0641-000

Introduction
Precautions
A 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.
Do not attempt to use a vaporizer that has been dropped.
A dropped vaporizer MUST be sent to the nearest Datex-
Ohmeda 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.
important: European Standard EN 740 - Anesthetic Workstations and Their Mod-
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 haz-
ardous output in the event of a device malfunction.
Datex-Ohmeda strongly recommends the use of anesthesia gas mon-
itoring with this equipment. Refer to local standards for mandatory
monitoring.
1107-0641-000 2/26/01 1-3

Tec 6 Plus Vaporizer
Symbols
Warnings and Cautions tell you about dangerous conditions that can
occur if you do not follow all instructions in this manual.
A WARNING Warnings tell about a condition that can cause injury to the
operator or the patient.
A, CAUTION — Cautions tell about a condition that can cause damage to
the equipment. Read and follow all warnings and cautions.
Symbol) Location Meaning
O Control Dial Standby setting
Interlock Block Setting mark - dial marking atignment point for required setting
Top Plate Label Direction of flow
ο
v Interlock Block Equi-potential stud - connection for minimizing electrical potential difference
Front Panel Auditory alarm mute button
4 | Display Panel 240 mi refill mark - indicates that an additional 240 ml of agent can be added
A Display Panel Symbolizes nominal agent level display when 390 ml of agent in sump (max.)
品 Display Panel Symbolizes agent level display when 60 ml or more of agent in sump (min.)
2-2 | Rear Label AC electrical supply must be single phase sinusoidal altemating current.
The voltage requirement for the vaporizer appears on this label.
À Rear Label The degree of protection against electric shock is Type B
—
人
A
Various Warning
Various Caution
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
XXXX and Maintenance manuals. The xxxx is the certifica-
tion number of the Notified Body used by
Datex-Ohmeda's Quality Systems.
1/23/01 1107-0641-000

In this section
1107-0641 -000 1/23/01
Description
What is a Tec 6 Plus Vaporizer? ne 2-2
Components... iii 2-6
Power supply Unit... ir 2-6
Filler assembly... iii nen 2-6
Drain plug トト ELLLER 2-7
Power cord and battery... rn err nen 2-7
Equi-potential stud nan nn 2-8
Sump ee 2-8
Heater elements nana n 2-8
ο ο een 2-8
Agent level senSor ener nn rer n nn 2-9
Tilt Switch iii cono nonos 2-9
2-1

Tec 6 Plus Vaporizer
What is a Tec 6 Plus Vaporizer?
2-2
The Tec 6 Plus Vaporizer adds Suprane™ (desflurane) inhalant anes-
thetic vapor to the medical gasses supplied to a patient. The Datex-
Ohmeda vaporizer should be used in anesthesia systems equipped
with a Selectatec® Series Manifold only.
The North American Drager 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 con-
nected to a suitable AC power supply.
The Tec 6 Plus Vaporizer is designed to meet UL 2601-1, EN 60601-
1 and IEC 601-2-13.
Figure 2-1 Tec 6 Plus Vaporizer, Datex-Ohmeda variant (left), and North American Drager variant (right)
1/23/01 1107-0641-000

1107-0641 -000
Important:
1/24/01
Description
Mechanical and electrical interlocks incorporated into the vaporizer
help to ensure that:
The vaporizer dial can only be turned from © (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 © (Standby).
European Standard EN 740 - Anesthetic Workstations and Their Mod-
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 haz-
ardous output in the event of a device malfunction.
Datex-Ohmeda strongly recommends the use of anesthesia gas mon-
itoring with this equipment. Refer to local standards for mandatory
monitoring.
2-3

Tec 6 Plus Vaporizer
2-4
À 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 mis-
matched.
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 Datex-
Ohmeda Field Operations Unit for servicing. See
Section 11 for complete shipping instructions.
1/23/01 1107-0641-000

Description
4A, 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,0 or pulsing the O, flush
faster than 1 pulse/sec over a time period of greater than
10 seconds.
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Tec 6 Plus Vaporizer
Components
Power supply unit 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.
Filler assem bly 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.
一 一 一
FILLER 一 一 ~ |
ASSEMBLY
AT
9
9)
FILLER |
PORT Use Only
| Desflurane
m
—Y
AA.43.037
FILLER
Figure 2-2 ¢ Filler assembly
2-6 1/23/01 1107-0641-000

Description
Drain plug The drain plug is located at the base of the vaporizer (see Figure 2-3).
A, CAUTION Do not remove the drain plug. Draining the vaporizer can
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.
Figure 2-3 « Vaporizer base
Power cord and !fthe AC power supply fails, a Duracell MN1604 or VARTA Energy
1107-0641-000
2000 battery incorporated in the base of the vaporizer provides power
for the auditory and visual alarms only. The battery must be replaced
annually.
battery
POWER CORD
DURACELL MN 1604 OR
VARTA ENERGY 2000 BATTERY
Figure 2-4 * Power cord and battery
1/23/01 2-7

Tec 6 Plus Vaporizer
Equi-potential stud
Sump
Heater elements
Sensors
2-8
The equi-potential stud ¥ is located on the top of the vaporizer. When
connected, it minimizes any electrical potential difference between the
vaporizer casing and the anesthesia system.
EQUI-POTENTIAL
STUD y
Figure 2-5 « Egui-potential stud
The sump contains the agent and includes the agent filling port, the
drain, the heaters and the agent Jevel sensor.
The sump has a total nominal capacity of 390 milliliters (ml) which con-
sists of a nominal 330 ml indicated volume and a nominal 60 ml
reserve.
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 vapor-
izer. This minimizes the current requirement.
While it is connected to the electrical supply, the casing of the vapor-
izer 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 acti-
vate the appropriate alarm indication.
1/23/01 1107-0641-000

Description
Agent level sensor 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 lev-
el in the sump. For more information, see section 3, Controls and Indi-
cators.
Tilt switch | lfthe 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.
D
DESFLURANE
МАГИИ
NİZ
в 圖
NO OUTPUT
AA.43.042
Figure 2-6 « Tilt indicator (NO OUTPUT light)
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Tec 6 Plus Vaporizer
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In this section
1107-0641-000 2/15/01
Controls and Indicators
Controls .ee 3-2
Dial and dial release "VV ーー 3-3
Lock lever eee 3-4
Auditory alarm mute button renee 3-4
Auditory and visual indicators..................... i 3-5
Alarm priority... ss e ete n 3-6
Status display... ii 3-7
WarHUD enn 3-7
Operational i 3-8
Agentleveldisplay........................................ 3-8
Low agent level... e ené 3-9
A 3-10
Alarmbatterylow...................................... εν 3-11
3-1

Tec 6 Plus Vaporizer
Controls
Note that only the Datex-Ohmeda vaporizer has the lock lever as
shown.
LOCK
LEVER
© EQUI-POTENTIAL STUD
DIAL RELEASE .
(O) STANDBY SETTING
CONCENTRATION DIAL
AUDITORY ALARM
MUTE BUTTON
POWER CORD
INDICATORS
FILLER PORT CONTROLS
BATTERY
COVER
POWER CORD POWER CORD
RETAINING PLATE CHANNEL
Figure 3-1 * Tec 6 Plus Vaporizer controls (Datex-Ohmeda variant shown)
3-2 1/23/01 1107-0641-000