Tec 7 Users Reference Manual Rev ZAA March 2012

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 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 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.

wCAUTION

U.S. Federal law restricts this device to sale by or on the order of a licensed medical practitioner. Outside the U.S.A, 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.

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 interlocks... 2-3 Vaporizer identification label... 2-3

3 Setup and Mounting Procedure Vaporizer mounting procedure... 3-1 Mounting the vaporizer... 3-2 Checking 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 Quik-Fil™... 4-9 Draining procedure with Quik-Fil...4-10

1175-0013-000

i

Tec 7 Vaporizer

5 Maintenance User maintenance... 5-1 Maintenance intervals... 5-1 Cleaning... 5-2 External cleaning... 5-2 Internal contamination... 5-2 Output concentration check... 5-2 Checking the calibration... 5-3 Analytical techniques... 5-4 Service Policy... 5-5

6 Principle of Operation Interlock 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 Back pressure... 7-9 Carrier gas composition...7-10 Time out of service...7-10 Effects of variables...7-10

Warranty

ii

1175-0013-000

1 Introduction

Precautions w 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., check 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. 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.

1175-0013-000

1-1

Tec 7 Vaporizer

Important

European Standard EN 740 - Anesthetic Workstations 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 keep 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.

only

w WARNING

Warnings tell about a condition that can cause injury to the operator or the patient.

w 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.

SEV ISO

Sevoflurane

ENF

Enflurane

HAL

Halothane

Isoflurane

Maximum Agent Level

1-2

OFF symbol/OFF setting

% v/v Percentage of anesthetic vapor per total volume.

z Z

Lock

w N

Caution or Warning

Unlock

Direction of flow

Minimum Agent Level

Stock number

Systems with this mark 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

1175-0013-000

2 Description

What is a Tec 7 Vaporizer? The Tec 7 Vaporizer is designed for use in continuous flow techniques of inhalation anesthesia. Each vaporizer is agent specific and is clearly labeled with the anesthetic agent that it is designed for. The vaporizer is temperature, flow and pressure compensated so that its output remains relatively constant despite cooling due to evaporation, variations in inlet flow and fluctuating pressures as described in Section 7, Effects of Variables. The vaporizer is designed to be used on Selectatec® Series Mounted Manifolds. The vaporizer can be installed on other Selectatec Manifolds but the interlock system is designed to function on Selectatec Series Mounted Manifolds only. Mounting a Tec 7 Vaporizer on a Selectatec 7 Compatibility Block is not recommended.

1175-0013-000

2-1

AB80008

Tec 7 Vaporizer

Figure 2-1 • Tec 7 Vaporizer

w 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 vaporizer can be degraded if the machine and vaporizer are mis-matched. Only operate the vaporizer with dry medical gases. If a vaporizer containing agent in the sump has been inverted, connect it to a gas scavenging system, set the dial to 5% and purge the vaporizer with the carrier gas at 5 liters/minute for 5 minutes.

w CAUTION

The vaporizer is intended to be operated in its upright position. Turn the vaporizer to

2-2

when it is not in use.

1175-0013-000

2 Description

Components Control dial

A single control dial with a concentration scale calibrated in percentage of anesthetic agent vapor per total volume (% v/v) sets the desired concentration of the anesthetic agent. A dial release in the dial assembly helps prevent 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.

Safety interlocks

The vaporizer incorporates an interlock mechanism. This mechanism also interfaces with the Selectatec® Series Mounted Manifold to help satisfy the following criteria: • The vaporizer must be locked onto the manifold before it can be turned ON. • Only one vaporizer at a time can be turned ON when two or more vaporizers are fitted on a Selectatec® Series Mounted Manifold. • The gas flow enters only the vaporizer that is turned ON. • Any unwanted anesthetic trace vapor is minimized after a vaporizer is turned to .

w WARNING

Earlier versions of the Selectatec Series Mounted Manifold that provide mounting positions for three vaporizers require that if only two vaporizers are fitted, then the center position must be occupied. If the center position is not occupied, the interlock that helps ensure that only one vaporizer at a time can be turned ON is ineffective. Later versions of the Selectatec Series Mounted Manifold that provide mounting positions for three vaporizers incorporate an additional interlock that helps ensure that only one vaporizer at a time can be turned ON even if the center position is not occupied.

Vaporizer identification label

A vaporizer identification label is affixed to the back panel of the vaporizer as illustrated on Fig. 2-2. An anesthesia system fitted with a vaporizer identification unit uses this label to identify the vaporizer type.

1175-0013-000

2-3

Tec 7 Vaporizer

w WARNING

Do not affix any additional labels or markings to the back panel. They may adversely affect the operation of the vaporizer identification unit.

1

AB80011

HALOTHANE

1. Vaporizer identification label

Figure 2-2 • Vaporizer identification label

2-4

1175-0013-000

3 Setup and Mounting Procedure

Vaporizer mounting procedure The vaporizer is designed to be used on Selectatec Series Mounted Manifolds. The vaporizer can be installed on other Selectatec Manifolds but the interlock system is designed to function on Selectatec Series Mounted Manifolds only. Mounting a Tec 7 Vaporizer on a Selectatec 7 Compatibility Block is not recommended.

w WARNING

Do not lift or support the vaporizer by holding the control dial. Handle the vaporizer with care at all times. 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. Earlier versions of the Selectatec Series Mounted Manifold that provide mounting positions for three vaporizers require that if only two vaporizers are fitted, then the center position must be occupied. If the center position is not occupied, the interlock that helps ensure that only one vaporizer at a time can be turned ON is ineffective. Do not use a vaporizer if the liquid level decreases below the minimum level. Before using a vaporizer allow it to attain the ambient temperature of the location in which it has to be used.

1175-0013-000

3-1

Tec 7 Vaporizer

Mounting the vaporizer Step 1 Åben

. AB80001

Set the dial to

Figure 3-1 • Setting the concentration dial

Step 2 Unlock the locking lever. Turn the lever counter-clockwise.

•

Make sure the lever releases.

AB80002

•

Figure 3-2 • Unlocking the locking lever

Step 3 Prepare the manifold.

•

Remove any plugs fitted to the vaporizer interlock block ports.

1

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 User’s Reference Manual. Replacement O-rings are supplied with each vaporizer.

2

AA13052

•

1. Vaporizer Interlock Block Port - ensure plugs removed 2. Replace Manifold Port Valve O-ring, if necessary

Figure 3-3 • Readying the manifold

3-2

1175-0013-000

3 Setup and Mounting Procedure

Step 4 •

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.

w CAUTION

AB80018

Install the vaporizer onto the manifold.

Figure 3-4 • Installing the vaporizer

Push the locking lever all the way down before turning it. The mechanism can be damaged if an attempt is made to turn the lever before it is pushed all the way down.

Step 5 Lock the vaporizer onto the manifold. •

Push the locking lever all the way down.

•

Turn it clockwise to the locked position to lock the vaporizer onto the manifold.

1

AB80004

1

1. Locking lever

Figure 3-5 • Locking the vaporizer onto a manifold

Step 6 Ensure that the vaporizer is correctly mounted (see instructions on the next page).

1175-0013-000

3-3

Tec 7 Vaporizer

Checking the vaporizer for correct mounting w WARNING

To help 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 level. If the vaporizer is visibly out of line, perform steps 2 and 3 as described in Removing the vaporizer from a manifold and remount it correctly. 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 Vaporizer mounting procedure). Verify that the interlock rods are in alignment by making sure that only one vaporizer at a time can be turned ON. Check the anesthesia system for leaks in accordance with the relevant User’s Reference Manual with the vaporizer dial turned to 0% and then repeat the check with the vaporizer dial turned to .

Removing the vaporizer from a manifold Step 1 Åben

Set the dial to

OFF

. AB80001

If the dial is not completely turned to the position the vaporizer cannot be released from the manifold. OFF

Figure 3-6 • Setting the dial

3-4

1175-0013-000

3 Setup and Mounting Procedure

Step 2 Locked

Unlock the locking lever. •

Turn the locking lever counterclockwise.

1

•

Release the locking lever and check that the locking lever springs up to the unlocked position to release the vaporizer from the manifold.

2

Unlocked

1

AB80003

2

1. Locking lever 2. Dial

Figure 3-7 • Unlocking the locking lever

Step 3

AB80019

Carefully lift the vaporizer up from the manifold.

Figure 3-8 • Lifting the vaporizer

1175-0013-000

3-5

Tec 7 Vaporizer

3-6

1175-0013-000

4 Operating Instructions

Setting the dial w WARNING

High percent dial settings combined with low gas flows may lead to hypoxic mixtures in the breathing circuit. Datex-Ohmeda strongly recommends the use of oxygen monitoring. The dial release must be operated to turn the dial from the

OFF

setting.

Do not turn the dial if the vaporizer is not properly locked onto the manifold.

Important

European Standard EN 740 - Anesthetic Workstations 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.

1175-0013-000

4-1

Tec 7 Vaporizer

Step 1 Press the dial release and turn the dial in a counter-clockwise direction from the setting.

n Åbe

AB80020

Note that it is not possible to turn on the vaporizer if an adjacent Tec series, (except Tec 3) is turned on.

Step 2 The vaporizer should not be used between and the first graduation mark.

Figure 4-1 • Releasing the dial

To avoid inadvertent delivery of small concentrations, turn the control dial to when the vaporizer is not in use.

4-2

1175-0013-000

4 Operating Instructions

Filling and draining the vaporizer w 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. Only fill the vaporizer when it is in an upright position. Failure to do so may result in the vaporizer being overfilled. To avoid explosive hazards, flammable anesthetic agents such as Ether and Cyclopropane must not be used in or with this vaporizer. Only anesthetic agents that comply with the requirements for non-flammable anesthetic agents in the IEC 60601-2-13 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 using high frequency electric surgery equipment may cause burns and is therefore not recommended in any application of this vaporizer. Do not fill the vaporizer unless the control dial is in the

position.

Do not turn the dial ON during filling or attempt to fill beyond the ¥ mark. Do not drain the agent into any container other than a properly marked drug container. Ensure that the filler cap is tightened prior to use.

1175-0013-000

4-3

Tec 7 Vaporizer When filling the Tec 7 Vaporizer, observe the following: • Periodically check the agent level. The vaporizer should be refilled at appropriate intervals. The vaporizer is designed to function according to specification as long as there is agent visible above the mark. • The vaporizer must be filled and used in an upright position. Small deviations from the upright position do not affect either the output or the safety of the vaporizer. • Every two weeks, preferably when the agent level is low, drain the contents of the vaporizer into an appropriately marked container and discard the agent. Less frequent intervals may be used when the anesthetic agent does not contain additives or stabilizing agents, but the procedure must be performed at least once every year. • The following steps should be taken for Halothane vaporizers: - Drain the vaporizer every two weeks - If Halothane is used infrequently the vaporizer should be drained after use. - The decomposition of halothane causes the release of halides, which may corrode metal components particularly in the presence of moisture. Also a preservative added to halothane by its manufacturers to impede decomposition can leave a residue, which may cause vaporizer components to stick. • If the vaporizer is not upright, check the agent level more frequently to avoid a misleading impression of the amount of agent in the vaporizer.

Step 1 Turn the vaporizer dial clockwise to the position. OFF

AB80021

n Åbe

Figure 4-2 • Turning the vaporizer OFF

4-4

1175-0013-000