Tec 820 and 850 Users Reference Manual Rev F Feb 2018

User responsibility This product will perform in conformity with the description 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. The user of this product shall have the sole responsibility for any malfunction which results from improper use of faulty maintenance, improper repair, damage, or alteration. User shall keep all relevant documentation, including this manual and accompanying labels.

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., check the local laws for any restriction that may apply.

Table of Contents Introduction Indications for use/Intended use... 1 General information... 1 Trademarks... 2 Symbols used on the equipment...2 Symbols associated with standards... 2 Symbols not associated with standards... 4 Abbreviations... 5 System information... 5 System classification... 5 Device standards IEC 60601-1:2005... 5 Preparing for use... 5

Setup and connections Setup safety...7 Elements of the vaporizer... 7 Configurations... 8 Installation and removal... 10 Mounting the vaporizer... 10 Removing the vaporizer from a manifold... 11

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Tec™ 820/850 Operation Operation safety... 12 Operating the vaporizer...12 Filling the vaporizer... 13

Preoperative checkout Performing preoperative checkout... 15

User maintenance Maintenance summary and schedule... 16 Service policy... 16 Comprehensive low pressure leak test... 16 Leak test with vaporizer mounted on anesthesia machine . . .16 Leak test with vaporizer not on anesthesia machine... 16 Concentration check... 17 Draining and drying the vaporizer... 18 Draining... 18 Drying...19 Purging... 19 Disposal... 19 General housekeeping... 19

Specifications and theory of operation Performance... 21 Essential performance...21 ii

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Table of Contents Environmental requirements... 22 Physical specifications... 22 MRI safety information... 22 Effects of variables... 23 The dilution effect of rebreathing...23 Barometric pressure... 23 Fluctuating back pressure... 24 Flow rate... 24 Temperature...25 Carrier gas composition... 25 Time out of service... 25

Index

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Introduction Introduction

Indications for use/Intended use The Tec™ 820 and Tec 850 vaporizers are designed for use in continuous flow techniques of inhalation anesthesia. They are available in isoflurane and sevoflurane. Each vaporizer is agent specific and is clearly labeled with the anesthetic agent for which it is designed. 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. The vaporizer is designed to be used on General Electric (Datex-Ohmeda, Inc.) Selectatec™ Series Mounted Manifolds. General information The User's Reference Manual is intended to provide training on the operation of the vaporizer. The vaporizer must be operated according to the instructions in this User's Reference Manual. This manual and its associated documentation must be studied before any attempt is made to install, operate, or maintain any part of the vaporizer. Make sure that all user documents, including this manual and accompanying labels, are obtained from the manufacturer. Additional copies of this manual can be requested from a local authorized Field Service Representative or an Authorized Distributor. Refer to the Technical Reference Manual for service information including special installation instructions, installation checklist, and other parts. The vaporizer should be operated by trained or authorized personnel. Do not use a vaporizer that has been modified in any way inconsistent with this User's Reference Manual or authorized service documentation. Tec 820 and Tec 850 vaporizers can be used with General Electric anesthesia machines that state they are compatible with ≥ Tec 6 Plus or ≥ Tec 7 vaporizers. When performing the vaporizer leak check follow the instructions for the Tec 7 vaporizer. The vaporizers are designed to be used on General Electric (DatexOhmeda, Inc.) Selectatec Series Mounted Manifolds. The vaporizers are not designed to be used on any other manufacturer's anesthesia machine. Mounting a Tec 820 or Tec 850 vaporizer on a Selectatec Compatible Block is not recommended. Configurations available for this product depend on local market and standards requirements. Illustrations in this manual may not represent all

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configurations of the product. Some filler types may not be available in all markets. Trademarks Tec, Selectatec, and Easy-Fil are trademarks of General Electric Company or one of its subsidiaries. SAFE-T-SEAL is a registered trademark of Baxter International Inc. Quik-Fil is a registered trademark of Abbott Laboratories. All other brand names or product names used in this manual are trademarks or registered trademarks of their respective holders.

Symbols used on the equipment Symbols replace words on the equipment or in product manuals. Warnings and cautions tell you about dangerous conditions that can occur if you do not follow all instructions in this manual. Warnings tell about a condition that can cause injury to the operator or the patient. Cautions tell about a condition that can cause damage to the equipment. Read and follow all warnings and cautions. Symbols associated with standards .

Symbol

2

Title

Standard reference Description number

Locking, general

IEC 60417-5569

IEC 60417: Graphical symbols for use on equipment

Unlocking

IEC 60417-5570

IEC 60417: Graphical symbols for use on equipment

"OFF" (power)

IEC 60417-5008

IEC 60417: Graphical symbols for use on equipment

Serial number

ISO 700-2498

ISO 7000: Graphical symbols for use on equipment - Registered symbols 2095452-001

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Catalog number

ISO 7000-2493

ISO 7000: Graphical symbols for use on equipment - Registered symbols

Refer to instruction manual/booklet (blue background)

ISO 7010-M002

ISO 7010: Graphical symbols - Safety colors and safety signs Registered safety signs

Operating instructions

ISO 7010-1641

ISO 7000: Graphical symbols for use on equipment - Registered symbols

MR conditional

ASTM F2503 Clause 7.3.2

ASTM F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

Manufacturer

ISO 7000-3082

ISO 7000: Graphical symbols for use on equipment - Registered symbols

Date of manufacture ISO 7000-2497

ISO 7000: Graphical symbols for use on equipment - Registered symbols

Keep dry

ISO 7000-0626

ISO 7000: Graphical symbols for use on equipment - Registered symbols

Humidity limitation

ISO 7000-2620

ISO 7000: Graphical symbols for use on equipment - Registered symbols

Temperature limit

ISO 7000-0632

ISO 7000: Graphical symbols for use on equipment - Registered symbols

3

Fragile, handle with ISO 7000-0621 care

ISO 7000: Graphical symbols for use on equipment - Registered symbols

Protect from heat and radioactive sources

ISO 7000-0615

ISO 7000: Graphical symbols for use on equipment - Registered symbols

General symbol for ISO 7000-1135 recovery/recyclable

ISO 7000: Graphical symbols for use on equipment - Registered symbols

Atmospheric pressure limitation

ISO 7000: Graphical symbols for use on equipment - Registered symbols

ISO 7000-2621

Authorized ISO 15223-1 5.1.2 representative in the European Community

ISO 15223-1: Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1:General requirements

Symbols not associated with standards .

Gas inlet into vaporizer

Gas outlet out of vaporizer

Maximum line

Minimum line

Caution: federal law prohibits dispensing without prescription

Unique device identifier

Ukraine national conformity

Eurasian conformity

GOST R Russian certification

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CE conformity mark 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. First CE marked in 2017

Abbreviations Abbreviations

Definition

CO2

Carbon dioxide

ISO

Isoflurane (purple)

O2

Oxygen

RH

Relative humidity

SEV

Sevoflurane (yellow)

System information System classification This product is classified as: • Continuous operation • Not for use with flammable anesthetics Device standards IEC 60601-1:2005 This device complies with the following standards: • ISO 80601-2-13 • ISO 5360 Anesthetic workstations used with this device shall comply with ISO 80601-2-13 where applicable. This device shall be used with the following systems where applicable: • Anesthetic gas delivery system per ISO 80601-2-13 • Anesthetic gas scavenging system per ISO 80601-2-13 • Anesthetic agent monitor per ISO 80601-2-55

Preparing for use Abide by all warnings and cautions in this manual. Failure to do so could degrade the performance of this device resulting in injury to the patient or care provider. 2095452-001

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WARNING •

Do not attempt to use a vaporizer that has been dropped until appropriate testing of the device is done to ensure it is working to specification. See "User maintenance" for instructions. If used without proper testing, the device may perform erratically and patient injury may occur or the user may be exposed to anesthetic agent by a leak.

•

The vaporizer should not be serviced or maintained while in use with a patient. Patient injury may occur or the user may be exposed to anesthetic agent by a leak.

•

Do not use lubricants that contain oil or grease. They may burn or explode in high O2 concentrations.

•

National Institute for Occupational Safety and Health (NIOSH) or equivalent recommendations for air exchange should be considered in any use environment.

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Setup and connections Setup and connections

Setup safety WARNING •

The vaporizer is designed for use with a General Electric Selectatec™ manifold. Do not use the vaporizer with other manufacturer’s anesthesia systems or in conjunction with other manufacturer’s vaporizers. Using the vaporizer with other systems may cause leaks, degradation of the interlock mechanism performance, and can add to the potential to mix two agents at the same time.

•

Only operate the vaporizer with dry medical gases. Vaporizer performance may be affected.

•

Do not modify, tamper with, or disassemble the vaporizer. Doing so can damage the unit and alter the accuracy of the control dial.

•

Earlier versions of Selectatec series mounted manifolds 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.

Elements of the vaporizer Be familiar with the elements of the vaporizer before reading instructions in the subsequent sections of this manual.

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13

1 2

12 11

3

10

9

8

4 7 5

AC.24.429

6

1. 2. 3. 4. 5. 6. 7.

Gas inlet into vaporizer Control dial Off mark Filler cap (filling port under filler cap) Agent level indicator Drain plug Drain nozzle

8. Minimum level line 9. Maximum level line 10. Interlock pin 11. Release button 12. Gas outlet out of vaporizer 13. Locking lever

Figure 1 • Vaporizer elements

Configurations Tec 820 and Tec 850 vaporizers are compatible with different filling systems. Use the pictures of filling ports and compatible anesthetic agent adapters or integrated closures to identify the configuration.

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For the agent color, ISO is represented with purple, and SEV is represented with yellow. .

Type

Filling port

Adapter/Integrated closure Purple (catalog number 1100-3025-000)

Easy-Fil SEV

Yellow (catalog number 1100-3028-000)

AC.24.476

AC.24.477

Easy-Fil™ ISO

AC.24.432

Quik-Fil™

AC.24.433

SAFE-T-SEAL

AC.24.434

Piramal Fill

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Installation and removal WARNING •

If the vaporizer has been tilted or inverted, inaccurate agent output may occur. Refer to "Purging" section in "User maintenance" for detailed information.

•

Before installing the vaporizer, ensure vaporizer port O-rings on Selectatec™ manifold are intact. Damaged O-rings may cause leaks.

•

If the vaporizer is not correctly mounted, patient injury could occur.

Mounting the vaporizer Handle the vaporizer with care at all times. 1. 2.

3.

4.

5.

10

Make sure that the control dial is set to the off position and locking lever is in the unlock position. Prepare the manifold. • Remove any plugs fitted to the vaporizer gas path ports. • Visually inspect Selectatec™ port O-rings. 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 (catalog number 1104-3025-000) are supplied with each vaporizer. Install the vaporizer onto the manifold. • Hold the main body of the vaporizer in an upright position with both hands. Do not lift or support the vaporizer by holding the control dial. • Lower the vaporizer onto the manifold, ensuring that the vaporizer gas path ports engage correctly with the manifold port valves. Lock the vaporizer onto the manifold. • Push the locking lever all the way down. • Turn it clockwise to the locked position. Make sure that the vaporizer is correctly mounted. If mounting fails, follow steps described in "Removing the vaporizer from a manifold" section to remove the vaporizer from the manifold and remount it correctly. If the vaporizer cannot be correctly mounted on the manifold, contact an authorized service representative.

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• •

•

Check that the vaporizer is in line with the manifold. If multiple vaporizers are mounted, check that the tops of the vaporizers are level. If the top of the vaporizer is not level, it is not correctly mounted. Attempt to lift the vaporizer off the manifold. If the vaporizer disengages from the manifold, it is not correctly mounted. Verify that the interlock mechanism works correctly by attempting to set the control dial of two vaporizers at the same time. If two vaporizers can be turned on at the same time, discontinue the use of the product and contact an authorized service representative. Check the anesthesia system for leaks in accordance with the section "Preoperative checkout".

Removing the vaporizer from a manifold 1. Make sure the control dial is set to the off position. 2. Unlock the locking lever. • Turn the locking lever counter-clockwise. • Release the locking lever and check that the locking lever springs up to the unlocked position to release the vaporizer from the manifold. 3. Carefully lift the vaporizer up from the manifold.

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Operation Operation

Operation safety WARNING •

Do not use the vaporizer unless it has been properly installed per the Installation Instructions and has passed all relevant anesthesia machine checkout steps. Patient injury may occur or the user may be exposed to anesthetic agent by a leak.

•

The vaporizer should not be used when the control dial is between the off position and the first graduation mark. Output concentration of the vaporizer in this region is not defined.

•

Before using the vaporizer, allow it to attain the ambient temperature of the location in which it will be used. Failure to do so could affect the accuracy of the vaporizer.

•

European, international, and national standards require that anesthetic agent and oxygen monitoring is used when the vaporizer is in use. Refer to local standards for mandatory monitoring. If the anesthesia machine does not have integral gas monitoring, use of a standalone gas monitor is highly recommended or patient injury may occur.

•

Do not use the vaporizer if the liquid level decreases below the minimum level line, patient injury may occur.

Operating the vaporizer Make sure that the liquid level in the vaporizer is above the minimum line before using by observing the agent level indicator. 1. 2. 3.

12

Press the dial release button. Turn the control dial counter-clockwise to the desired concentration setting. Turn the control dial to adjust the concentration setting as needed. Turn the control dial clockwise to the off position when delivery of agent is complete.

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Filling the vaporizer WARNING •

Do not fill the vaporizer with any agent other than the agent specified in product labeling. The vaporizer is designed for that agent only. Do not use the vaporizer with flammable anesthetic agents. If any substance other than that specified is used, patient injury could occur from wrong delivery, or user and patient may be exposed to an explosion hazard.

•

Do not put water or any other solvent into a vaporizer. Vaporizer parts may be damaged and output accuracy and composition of the output gas may be affected.

•

Do not attempt to fill the vaporizer beyond the maximum level line. Vaporizer performance may be affected.

Before filling the vaporizer, allow the vaporizer and anesthetic agent container to attain the ambient temperature. 1.

2.

3. 4.

5.

6. 7.

Make sure the control dial is in the off position and vaporizer is in the upright position. Failure to do so may result in the vaporizer being overfilled. For bottles with an integrated adapter (such as Quik-Fil™, SAFE-TSEAL, and Piramal Fill), remove the integrated adapter cap. For bottles without an integrated adapter, remove the bottle cap and apply a bottle adapter following the adapter instructions. Remove the filler cap. Align the bottle adapter keys with the index slots on the filler port. Insert the agent bottle into the filling port. Press the agent bottle fully into the vaporizer filling port. Hold the bottle in the fully-inserted position. Allow the liquid to flow into the vaporizer until the maximum level mark or desired level on the agent level indicator is reached. To help prevent overfill, make sure the agent level is at or below the maximum level line. Release the bottle and remove the bottle from the filling port. Do not reinsert the bottle into the filling port if the vaporizer is already full. A small amount of anesthetic agent may leak to the environment during disconnection of the adapter from the filling port. Remove the bottle adapter (if applicable). Put the cap on the agent bottle or on the integrated adapter.

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8.

14

Put the cap on the vaporizer filling port. Make sure that the filler cap is tight.

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Preoperative checkout Preoperative checkout

Performing preoperative checkout Preoperative checkout is a series of tests to ensure an anesthesia system is in good operating condition and can be used in a clinical setting. The vaporizer is an important part of the checkout process because it is in circuit with the low pressure system of the anesthesia machine and could potentially contribute to gas leaks if not mounted or not functioning properly. Refer to the anesthesia machine User’s Reference Manual for recommendations on frequency of the checkout procedure. 1. 2.

Follow the instructions for the anesthesia machine checkout procedure. When the anesthesia machine tests for vaporizer leaks, run the test with the vaporizer in the off position and then rerun the test with the control dial set at 1% concentration. Additional control dial positions can optionally be checked.

If anesthesia machine checkout process is not available, see the "Comprehensive low pressure leak test" in "User maintenance" section to test the vaporizer for gas leaks. If vaporizer leak is found during the checkout, verify that the vaporizer is correctly mounted on the manifold, the cap is properly tightened and its sealing surface is intact, and run the checkout procedure again. If the checkout procedure fails, do not use the vaporizer and contact local authorized service representative.

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