Datex-Ohmeda Tec 7 Instructions de montage
Tec 7 Vaporizer
User’s Reference Manual
User Responsibility
This Product will perform in conformity with the description thereof contained
in this User’s Reference manual and accompanying labels and/or inserts,
when assembled, operated, maintained, and repaired in accordance with the
instructions provided. This Product must be chec ed periodically. A defective
Product should not be used. Parts that are bro en, 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 Customer Service 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. 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.
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CAUTION
U.S. Federal law restricts this device to sale by or on the order of a
licensed medical practitioner. Outside the U.S.A, chec 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
T
his 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.
1175-0013-000
i
Table of Contents
1 Introduction
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
2 Description
What is a Tec 7 Vaporizer? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Control dial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Safety interloc s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Vaporizer identification label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Setup and Mounting Procedure
Vaporizer mounting procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Mounting the vaporizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Chec ing the vaporizer for correct mounting . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Removing the vaporizer from a manifold . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
4 Operating Instructions
Setting the dial . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
Filling and draining the vaporizer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Filling procedure with funnel filler . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Draining procedure with funnel filler . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Filling procedure with Easy-Fil
™
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-7
Draining procedure with Easy-Fil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Filling procedure with Qui -Fil
™
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-9
Draining procedure with Qui -Fil . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-10
Tec 7 Vaporizer
ii
1175-0013-000
5 Maintenance
User maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Maintenance intervals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
External cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Internal contamination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Output concentration chec . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Chec ing the calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Analytical techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-4
Service Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-5
6 Principle of Operation
Interloc mechanism . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Delivery of gas/agent vapor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Bypass circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Vaporizing chamber circuit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
7 Specifications
Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Weight and dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Flow characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Effects of variables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Anesthetic agent consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Barometric pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Ambient temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Bac pressure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Carrier gas composition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10
Time out of service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10
Effects of variables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10
Warranty
1175-0013-000
1-1
1 Introduction
Precautions
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WARNING
Do not fill the vaporizer with any agent other than the agent specified on
the front label. The vaporizer is designed for that agent only. If any
substance other than that specified is used, patient injury could occur.
United States (U.S.) Federal law restricts this device to sale by or on the
order of a licensed medical practitioner. Outside the U.S., chec local
laws for any restrictions that may apply.
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.
Do not use malfunctioning equipment. Ma e 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.
Tec 7 Vaporizer
1-2
1175-0013-000
Important
European Standard EN 740 -
Anesthetic Wor stations and Their Modules
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.
Requests for servicing facilities, advice or assistance must be addressed to a local
Datex-Ohmeda office.
Additional copies of this manual, can be requested from a local Datex-Ohmeda Field
Operations Unit or a Datex-Ohmeda Authorized Distributor.
Datex-Ohmeda strongly recommends that you eep all relevant documentation,
including this manual and accompanying labels, immediately available to all users.
Symbols
Warnings and Cautions tell you about conditions that can occur if you do not follow all
instructions in this manual.
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WARNING
Warnings tell about a condition that can cause injury to the operator or
the patient.
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CAUTION
Cautions tell about a condition that can cause damage to the
equipment. Read and follow all warnings and cautions.
Caution: federal law prohibits dispensing
without prescription.
OFF symbol/OFF setting
SEV
Sevoflurane
% v/v
Percentage of anesthetic vapor per total volume.
ISO
Isoflurane z
Loc
ENF
Enflurane Z
Unloc
HAL
Halothane w
Caution or Warning
Maximum Agent Level NN
NN
Direction of flow
Minimum Agent Level Stoc number
Systems with this mar agree with the European
Council Directive (93/42/EEC) for Medical
Devices when they are used as specified in their
User’s Reference manuals. The xxxx is the
certification number of the Notified Body used
by Datex-Ohmeda's Quality Systems.
Serial number
onl
y
1175-0013-000
2-1
2 Description
What is a Tec 7 Vaporizer?
The Tec 7 Vaporizer is designed for use in continuous flow techniques of inhalation
anesthesia. Each aporizer is agent specific and is clearly labeled with the anesthetic
agent that it is designed for.
The aporizer is temperature, flow and pressure compensated so that its output
remains relati ely constant despite cooling due to e aporation, ariations in inlet flow
and fluctuating pressures as described in Section 7, Effects of Variables.
The aporizer is designed to be used on Selectatec
®
Series Mounted Manifolds. The
aporizer can be installed on other Selectatec Manifolds but the interlock system is
designed to function on Selectatec Series Mounted Manifolds only. Mounting a Tec 7
Vaporizer on a Selectatec 7 Compatibility Block is not recommended.
Tec 7 Vaporizer
2-2
1175-0013-000
Figure 2-1 • Tec 7 Vaporizer
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WARNING
Improper use may result in patient injury.
This manual and its associated documentation must be studied before
any attempt is made to install, operate or clean any part of the Tec 7
Vaporizer.
The performance of the anesthesia machine and aporizer can be
degraded if the machine and aporizer are mis-matched.
Only operate the aporizer with dry medical gases.
If a aporizer containing agent in the sump has been in erted, connect it
to a gas sca enging system, set the dial to 5% and purge the aporizer
with the carrier gas at 5 liters/minute for 5 minutes.
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CAUTION
The aporizer is intended to be operated in its upright position.
Turn the aporizer to when it is not in use.
AB80008
2 Description
1175-0013-000
2-3
Components
Control dial
A single control dial with a concentration scale calibrated in percentage of anesthetic
agent apor per total olume (% / ) sets the desired concentration of the anesthetic
agent.
A dial release in the dial assembly helps pre ent accidental displacement of the
control dial from the position. To select an ON setting, squeeze the dial release
and simultaneously rotate the dial counter-clockwise.
The dial and dial release are designed to enable an ON setting to be selected using
only one hand.
afety interlocks
The aporizer incorporates an interlock mechanism. This mechanism also interfaces
with the Selectatec
®
Series Mounted Manifold to help satisfy the following criteria:
• The aporizer must be locked onto the manifold before it can be turned ON.
• Only one aporizer at a time can be turned ON when two or more aporizers are
fitted on a Selectatec
®
Series Mounted Manifold.
• The gas flow enters only the aporizer that is turned ON.
• Any unwanted anesthetic trace apor is minimized after a aporizer is turned to
.
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WARNING
Earlier ersions of the Selectatec Series Mounted Manifold that pro ide
mounting positions for three aporizers require that if only two aporizers
are fitted, then the center position must be occupied. If the center
position is not occupied, the interlock that helps ensure that only one
aporizer at a time can be turned ON is ineffecti e.
Later ersions of the Selectatec Series Mounted Manifold that pro ide mounting
positions for three aporizers incorporate an additional interlock that helps ensure
that only one aporizer at a time can be turned ON e en if the center position is not
occupied.
Vaporizer identification
label
A aporizer identification label is affixed to the back panel of the aporizer as
illustrated on Fig. 2-2.
An anesthesia system fitted with a aporizer identification unit uses this label to
identify the aporizer type.
Tec 7 Vaporizer
2-4
1175-0013-000
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WARNING
Do not affix any additional labels or markings to the back panel. They
may ad ersely affect the operation of the aporizer identification unit.
1. Vaporizer identification label
Figure 2-2 • Vaporizer identification label
HALOTHANE
AB80011
1
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