Tec 6 Plus Vaporizer Operation and Maintenance Manual Rev ZAD May 2018

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.

w 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.

Table of Contents

1/Introduction What this manual includes... 1-2 Important ... 1-2 Precautions ... 1-3 Important: ... 1-3 Symbols... 1-4

2/Description What is a Tec 6 Plus Vaporizer? ... 2-2 Important: ... 2-3 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

3/Controls and Indicators Controls ... 3-2 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

4/Setup and Mounting Procedure 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

5/Operating Instructions Alarm and display test ... 5-2

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Tec 6 Plus Vaporizer

Preoperative checkout ...5-5 Setting the dial ...5-10 Important ...5-10 Filling the vaporizer ...5-13 Filling procedure ...5-14

6/Maintenance User Maintenance ...6-2 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

7/Principle of Operation Alarm and indicator display ...7-2 Delivery of gas/agent vapor ...7-2

8/Troubleshooting Troubleshooting guide...8-2

9/Specifications 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

10/Servicing Policy Servicing policy ...10-2

Index

ii

1107-0641-000

1Introduction

In this section

What this manual includes ...1-2 Precautions...1-3 Symbols ...1-4

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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 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 DatexOhmeda Authorized Distributor. Datex-Ohmeda strongly recommends that you keep all relevant documentation, including this manual and accompanying labels, immediately available to all users.

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Introduction

Precautions w WARNING

Do not fill the vaporizer with any substance other than desflurane as specified on the front label. If any substance other than 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 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 DatexOhmeda Field Operations Unit for servicing. See Section 10 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. Do not operate the vaporizer at an angle greater than 10° with respect to gravity. Improper agent delivery may occur.

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.

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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.

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.

Symbol

Location

Meaning

q

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.)

p

Rear Label

AC electrical supply must be single phase sinusoidal alternating current. The voltage requirement for the vaporizer appears on this label.

j

Rear Label

The degree of protection against electric shock is Type B

k

Top Plate Label

Direction of flow

w

Various

Warning

w

Various

Caution

Rear Label

Mercury less than 0.1%

1-4

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Introduction

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.

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1-6

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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

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Tec 6 Plus Vaporizer

What is a Tec 6 Plus Vaporizer? The Tec 6 Plus Vaporizer adds desflurane inhalant anesthetic 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 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.

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nly e eo Us uran sfl De

nly e eo Us uran sfl De

Figure 2-1 • Tec 6 Plus Vaporizer, Datex-Ohmeda variant (left), and North American Dräger variant (right)

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Description

Mechanical and electrical interlocks incorporated into the vaporizer help to ensure that:

Important:

•

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).

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.

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Tec 6 Plus Vaporizer

w 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. 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 10 for complete shipping instructions.

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Description

w 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 H2O or pulsing the O2 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 assembly

The filler assembly uses an agent specific fitting to ensure that only a desflurane specific bottle equipped with a valve can be inserted to fill the vaporizer.

FILLER PORT

Use Only Desflurane

AA.43.037

FILLER ASSEMBLY

FILLER

Figure 2-2 • Filler assembly

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Description

Drain plug

The drain plug is located at the base of the vaporizer (see Figure 2-3).

w 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.

DRAIN PLUG

Figure 2-3 • 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.

D

POWER CORD

DUR

L L E C A R U D

mn A C E 6 ghc 23r L L hjv

DURACELL MN 1604 OR VARTA ENERGY 2000 BATTERY

Figure 2-4 • Power cord and battery

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Tec 6 Plus Vaporizer

Equi-potential stud

The equi-potential stud Y 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

Figure 2-5 • Equi-potential stud

Sump

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.

Heater elements

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.

Sensors

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.

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Description

Agent level sensor

1107-0641-000

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.

2-9

Tec 6 Plus Vaporizer

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