GE Healthcare Tec 6 Plus Vaporizer Operation and Maintenance ManualUserHesponsibiity 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 ofits 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 responsibilty for any ‘malfunction which results from improper use, faulty maintenance, improper repair, damage, or alteration by anyone other than Datex-Ohmeda. 4. 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 11107-0641-000 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, ete. and *O” are not used. 0197 wveai01Table of Contents ‘introduction What this manual includes. Precautions... Symbols 12 2Description What is a Tec 6 Plus Vaporizer?... Components... Power supply unit. Filler assembly. Drain plug, Power cord and battery... Equi-potential stud .. Sump... Heater elements. Sensors. Agent level sensor. Titt switch 26 3/Controls and Indicators Controls Dial and dial release. Lock lever. Auditory alarm mute button Auditory and visual indicators. ‘Alarm Priority Status display .. Warm-up ... Operational ‘Agent level display Low agent level No output. on 10 Alarm battery low .. SAT 4/Setup and Mounting Procedure 42 Vaporizer setup procedure sen Installing the battery and the power cord 42 Vaporizer mounting Procedure. 46 ‘Mounting the Datex-Ohmeda vaporizer... Checking the vaporizer for correct mounting 4-10 Removing the Datex-Ohmeda vaporizer from a manifold .. 411 1107-0641-000 372001 iTec 6 Plus Vaporizer 5/Operating Instructions Alarm and display test 52 Preoperative checkout... 5.5 Setting the dial 510 Filing the vaporizer. 5-13 Filling procedure S14 6/Maintenance Cleaning se 62 External cleaning sestntntssnsintnsi 6-2 Internal contamination ..........0.-.00 sesesenenesensonsnaen 6-3 Output concentration CheCk........-..- - sesscone 6-3 Changing the battery 64 Spare parts 7/Principle of Operation Alarm and indicator display Delivery of gas/agent vapor... 8/Troubleshooting Troubleshooting guide ....n:nnnnnnnnnninnnnnnnnnnnnnnnnnnnnn a2 9/Specifications Calibration... z Electrical supplies Performance .. Classification .. Ms Weight and dimensions. Flow characteristics. Effects of output at varied altitudes. Effects of ambient temperature. Effects of back pressure ..... Effects of carrier gas composition 10/Warranty Warranty 102 11/Servicing Policy 112 Servicing policy Index 4 3211 1107-064-000Introduction In this section — what this manual includes ceoeor aod Precautions nse 13 Symbols sold 1107-0681-000 1/29/01 ut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 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 difters 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 dest es 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 filing 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 al users. sWea011107-0841-000Introduction Precaut ns 4. 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 property, 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, 1107-0641-000 226/01 13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 AX WARNING — Warnings tell about a condition that can cause injury to the operator or the patient. 4, CAUTION — Cautions tell about a condition that can cause damage to the equipment. Read and follow all warnings and cautions. [Symbol] Loe: Meaning 14 Control Dial Standby setting Interlock Block Setting mark - dial marking alignment point for required setting Interiock Block | Equ-potential stud ~ connection for minimizing electrical potential ference Front Panel | Aueitory alarm mute button Display Panel | 240 mi refi mark - indicates tat an addtional 240 ml of agent can be added Display Panel | Symbokzes nominal agent level display wien 390 mi of agent in sump (max) Display Panel__| Symbokzes agent level display when 60 mil or more ofagentin sump (min) Rear Label ‘AC electrical supply must be single phase sinusoidal altemating current ‘The voltage requirement forthe vaporizer appears on this label Rear Label _| The degree of protection against electric shock is Type B Top Plate Label Direction of flow Various Warning BIBT | b>): [elm] a]@)<] «lc Various Caution when they are used as specified in their Oper and Maintenance manuals. The xxxx is the certifica- tion number of the Notified Body used by Datex-Ohmeda's Quality Systems. ‘Systems with this mark agree with the European. C E Counci Directive (83/42/EEC) for Medical Devices XXX ‘v25i011107-0641-000In this section 1107-0841-000 esi Description What is a Tec 6 Plus Vaporizer? Component... Power supply unit Filler assembly... Drain plug...... Power cord and battery. Equi-potential stud... Sump Heater elements .. Sensors... ‘Agent level sensor. Tilt switch, 2aTec 6 Plus Vaporizer What is a Tec 6 Plus Vaporizer? ‘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 (lef), and North American Dréger variant (ight) 22 ‘y2aio11107-0841-0001107-0641-000 Important: 2401 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 tumed 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. 23Tec 6 Plus Vaporizer 24 A 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 bums 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. v2aet 1107-0641-000A. CAUTION 1107-0641-000 1/23/01 Description 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,O or pulsing the O, flush faster than 1 pulse/sec over a time period of greater than 10 seconds. 25Tec 6 Plus Vaporizer Components Power supply u Filler assembly 268 ‘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. ‘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 fil the vaporizer. LER Assenaty Figure 2-2 «Filler assembly sv2ai01 1107-0641-000Description Drain plug The drainplugis 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 ___ Ifthe AC power supply fails, a Duracell MN1604 or VARTA Energy battery 2000battery incorporated in the base of the vaporizer provides power for the auditory and visual alarms only. The battery must be replaced annually owen coRD DURACELL Mw 104 08 ARTA ENERGY 2000 BATTERY Figure 2-4 + Power cord and battery 1107-0641-000 1729/01 27Tec 6 Plus Vaporizer Equi-potential stud 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. oy-porewmaL suo" 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 con- sists of a nominal 330 ml indicated volume and a nominal 60 ml reserve Heater elements Two 100W neater 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 altemates 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. Sensors __ Internal electrokmechanical sensors monitor and maintain the fresh gas/agent vapor pressure balance and the agent volume. The intemal sensors monitor and display operational status and acti- vate the appropriate alarm indication. 28 ‘vza011107-0841-000Agent level sensor Tilt switch 1107-0641-000 1/2301 Description ‘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 380 mi of agent, the LCD level displays the agent lev- elin the sump. For more information, see section 3, Controls and Indi- cators. I the vaporizer is tited for 10 seconds while the dial is on and itis in operational mode and delivering vapor, vapor delivery will be stopped, as indicated by the flashing NO OUTPUT light and auditory alarm. DESFLURANE > Vly Figure 2-6 + Ttt indicator (NO OUTPUT light) 29Tec 6 Plus Vaporizer 240 This page left blank intentionally. 1es01 1107-0641-000Controls and Indicators In this section — controis. - Dial and dial release . Lock lever... ‘Auditory alarm mute button... Auditory and visual indicators. ‘Alarm priority Status display... Warm-up.. Operational Agent level display... Low agent level. No output... Alarm battery 1OW soon 1107-0641-000 2/1501 3aTec 6 Plus Vaporizer Controls Note that only the Datex-Ohmeda vaporizer has the lock lever as shown. vet = Qu POTENTIAL STUD Uys _- Dia. neLease CONCENTRATION DIAL AUDITORY ALARM (MUTE BUTTON POWER CORD IwpIcaTORS FILLER PORT CONTROLS. BATTERY ‘COVER, POWER CORD Power conD RETAINING PLATE ‘CHANNEL Figure 3-1 + Tec 6 Plus Vaporizer controls (Datex-Ohmeda variant shown) 32 ‘year 1107-0641-000Controls and Indicators Dial and dial release — when the operational light is on, push the dial release and turn the dial 1107-0641-000 eae to set the agent concentration. The dial cannot be turned from the () (standby) setting as long as the WARM-UP light is on. Figure 3-2 « Concentration dial You can select the level of agent concentration from 1% to 18%. The dial is marked at intervals of 1% from 1% to 10% and at intervals of 2% from 10% to 18%. Use the dial release again to tum the dial from the © (standby) setting and to tum the dial from 12% to a higher percent setting. All other set- tings can be made without operating the dial release. A solenoid interlock mechanism ensures that the dial can be turned, from the © (standby) setting only when the green OPERATIONAL light is iluminated. DESFLURANE Figure 3-3 + Operational ight 33Tec 6 Plus Vaporizer Lock lever — Only the Datex-Ohmeda vaporizer has a lock lever. Turn the lever fully clockwise to lock the vaporizer in position t a — fi Figure 3-4 # Lock lever Auditory alarm mute Push to silence alarms. Hold for three seconds to start the alarm test button (speaker sounds and indicators light up). >3sec= Alarm test <3 sec = Alarm silence Figure 3-5 * Mute button +4 ‘v2sios1107-0641-000Controls and Indicators Auditory and visual indicators ‘The status of the vaporizer is indicated by both visual and auditory alarms (see Status display) Press the auditory alarm mute button (3), located above the display panel, fo mute an alarm (see Agent level display and Alarm battery fom. The LCD agent level display indicates the level of agent. The range is between 60 mi and 390 ml. When the indicator s below the 240 mi refill mark .¢, you can add an additional 240 mi of agent. AuoITORY ALAN Mute BUTTON g & tl oreen (DESFLURANE ra i al DISPLAY io K lo Sa pao Benm ML) rast ca Es Four 26+ Ft pana! day 1107-0641-000 1/23/01 35Tec 6 Plus Vaporizer Alarm Priority The Tec 6 Plus Vaporizer has three distinct alarm prioiies. For each priority there is a different set of visual and auditory signals: Alarm Priority Visual Signal Auditory Signal High Rapid red flashing | Two sets of five light audio beeps every 40 seconds a Medium ‘Amber flashing light | One set of three au- dio beeps every 25 seconds. Low Continuous amber | One audio beep light only Note: An internal processor failure may also present an intermittent red No Output LED and alarm tone, Vap. Condition | Low Battery | Low Agent No Output Dial ON Medium Medium High Priority Priority Priority Dial ON, Low Priority | Audio High Priority Alarm Silence silenced for (pressing Si- Pressed 120 seconds, | tence (4) has then audio" | no effect) active Dial turned | Low Priority | Low Priority | Low Priority wo (dial locked | (dial locked Until condition | untit condition corrected) —_| corrected) 36 Figure 3-7 + Alarm priorities: ‘vzaio11107-0641-000Status display 1107-0641-000 Warm-up vegio1 Controls and Indicators Ifthe dial is at © when an alarm occurs, the auditory alarm does not repeat. ‘The amber WARM-UP light is continuously illuminated when the va- porizer is in warm-up mode. The dial cannot be turned from © when the vaporizer is warming up. DESFLURANE Figure 3-8 + Warm-up 37Tec 6 Plus Vaporizer Operational Agent level display The green OPERATIONAL light is continuously illuminated when the vaporizer is in operational mode. The dial can be turned from () when the vaporizer is operational. DESFLURANE Sow ll Sow (Be Seon Ul 5 q Foure 3.9 + Operational ‘The LCD agent level display consists of a series of bars that indicate the nominal volume of agent in the vaporizer sump. The lal symbol means there is approximately 390 ml of agent in the ‘sump. The | symbol means there is 60 ml or more of agent in the ‘sump. No bar displayed means there is 60 mi or less of agent in the sump. As the sump fils, the first agent level indicating bar appears in the LCD. volume display when there is between 60 and 80 ml of agent in the ‘sump. As the level increases, more bars are displayed, as illustrated in Figure 3-9, and as the level decreases, fewer bars are displayed When the bars are either level with or below the ¢ symbol, the sump can accommodate 240 ml of agent, which is one full bottle. When there are no bars visible, as illustrated in Figure 3-10, the LOW AGENT level alarm is activated (see Low agent lever). Note: The agent level display is calibrated to be most accurate when the vaporizer is in a perfectly level position. Deviations from a level po- sition affect the accuracy of the agent level display and may acti- vate the LOW AGENT level alarm. ‘yesio11107-0841-000Controls and Indicators ‘This alarm indicates that there is less than 60 mi of agent remaining in the sump and agent should be added. Pressing () mutes the auditory alarm for a period of 120 seconds to allow time to fill the vaporizer to above 60 rm. Ifa LOW AGENT condition occurs during normal operation, the alarm is activated but the green OPERATIONAL light remains illuminated. Low agent level NX DESFLURANE J gw < Bete IU § Figure 3-10 Low agent level 1107-0641-000 1201 39Tec 6 Plus Vaporizer No output This alarm indicates that the vaporizer has shut down and is no longer delivering vapor. ‘The NO OUTPUT alarmis activated if the dial isin the ON position and any one of the following occurs: + The agent level decreases to below 20 ml + The vaporizer s tilted for more than 10 seconds, + Apower failure of longer than 10 seconds duration occurs. + An internal malfunction is detected Sow lu «| 3 i Sire u Figure 3-11 + No output Ifthe NO OUTPUT alarm occurs while the vaporizer is in use, the va- porizer dial must be tumed to ©) This action de-escalates the alarm to a low priority andilluminates the amber light continuously. Either an alternative vaporizer or an alterna- tive method of anesthesia must be used. Ifthe NO OUTPUT alarm is activated as.a result of a power failure and the dial is at ©) when the power supply is restored, the alarm and dis- play testis activated and the vaporizer returns to either the WARM-UP or the OPERATIONAL mode. It the cial is not at © when the power supply is restored, the NO OUT- PUT alarm continues and can only be cancelled by turning the dial 0.0. In this condition, the alarm and display testis not activated and the vaporizer returns to either the WARM-UP or the OPERATIONAL mode. ‘2301 1107-0641-000Controls and Indicators Alarm battery low This alarm indicates that the alarm battery voltage is low. A new bat- tery must be installed as soon as practical to support the NO OUTPUT alarm in the event of a subsequent external power failure. I an ALARM BATTERY LOW condition occurs during normal opera- tion, the alarm is activated but the green OPERATIONAL light remains illuminated. \ DESFLURANE a seme < we g teretriow Ll} 3 Figure 3-12 + Alarm battery low 1107-0681-000 1/29/01 sayTec 6 Plus Vaporizer 32 This page left blank intentionally. sesion 1107-0641-000Setup and Mounting Procedure In this section vaporizer setup procedure. Instaling the battery and the power COT... Vaporizer mounting Procedure Mounting the Datex-Ohmeda vaporizer Checking the vaporizer for correct mounting sere AO Removing the vaporizer from a manifold 414 1107-0641-000 2/15101 41Tec 6 Plus Vaporizer Vaporizer setup procedure A, WARNING A CAUTION Installing the battery and the power cord Step 1 Remove the battery cover. + Inver the vaporizer. ‘+ Unscrew the battery cover securing screw. ‘+ Remove the battery cover. 42 The battery terminals must be firmly clipped onto the battery to help prevent a possible disconnection when the vaporizer is moved. Use only a Datex-Ohmeda power cord to connect the vaporizer to the electrical supply. When routing the power cord to the electrical supply, ensure that it does not interfere with the correct functioning of other equipment. Do not support the vaporizer by holding the control dial and/or locking lever. Hold the main body of the vaporizer with both hands and keep the vaporizer in an upright position. Failure to do so may cause the vaporizer to malfunction. Install only a Duracell MN1604 or VARTA Energy 2000 nine volt battery in the vaporizer. If any other battery is installed, it can damage the vaporizer. ‘Anew battery and the power cord supplied with the vaporizer must be fitted during initia installation if they are not already installed. ATTERY COVER ‘SECURING SCREW wonzen vee Figure 4-1 « Removing the battery cover ‘2301 1107-0641-000Step 2 Install the battery. * Clip the battery terminals firmly onto the new battery, observing the correct polarity. + Insert the battery into the vaporizer. Step 3 Fit the battery cover to the base of the vaporizer and tighten the securing screw. 1107-0841-000 1/23/01 Setup and Mounting Procedure barren TERMINALS, N\ DURACELL MW 1606 OR VARTA NERGY 2000, barren Figure 4-2 + instaling the battery barren cover SECURING SCREW Figure 4-3 + Replacing the battery cover 43Tec 6 Plus Vaporizer Step 4 Install the power cord. Remove the power cord retaining plate. Fit the power cord firmly into the socket of the vaporizer. Feed the power cord into the power cord channel. Clip the power cord retaining plate back into the base. (On the North American Drager vaporizer, feed the lead around the back of the vaporizer and secure the lead by means of the 'P” aiip. POWER CORD ‘POWER CORD : CHANNEL owen coRD — RETAINING PLATE Figure 4-4 « Installing the Datex-Ohmeda power cord POWER CORD - owen conD owen con — Hen RETAINING PLATE oes Figure 4-5 « Instaling the North American Drager power cord ‘yet 1107-0641-000Setup and Mounting Procedure Vaporizer mounting Procedure A WARNING 1107-0641-000 1/29/01 The Tec 6 Plus vaporizer for North American Drager (NAD) must be installed on a NAD anesthesia machine equipped with an exclusion manifold. The installation must be performed by an individual trained in the servicing of NAD anesthesia equipment. Each vaporizer is supplied with O-rings and screws for the service person to install the vaporizer onto the manifold. Do not mount the vaporizer downstream of the common gas outlet. Mounting the vaporizer in any position other than that recommended in this manual can cause patient injury. Do not connect any vaporizer other than a Tec 6 Plus, Tec 6, Tec5, or Tec 4 onto a Selectatec™ Series Manifold. Connecting any other vaporizer onto the manifold may make the interlock system ineffective and can result in the ability to administer anesthetic agent mixtures, possibly causing patient injury. 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. Some versions of the Selectatec™ Series Mounted Manifold provide mounting positions for three vaporizers. These versions require the center position to be occupied even if only two vaporizers are fitted. If the center position is not occupied, the interlock which helps to ensure that only one vaporizer at a time can be turned on is ineffective. 45Tec 6 Plus Vaporizer Mounting the Datex- Later versions of the Selectatec™ Series Mounted Manifold that pro- Ohmeda vaporizer _ vide mounting positions for twee vaporizers incorporate an additional interlock which ensures that only one vaporizer at a time can be turned cn even if the center position is not occupied. Step 1 Set the dial to ©. Figure 4-6 + Setting the concentration lal Step 2 Unlock the locking lever. t * Tum the lever counterclockwise. + Make sure the lever releases. f — a Figure 4-7 + Unlocking the locking lever 46 ‘29101 1107-0641-000Step 3 Ready the manifold. + Remove any plugs fitted to the vaporizer interlock block ports. + Verify that each manifold port valve O-ting is intact. necessary, remove the existing O-rings and fit one new O-ring to each port valve, as described in the relevant anesthesia system O & M Manual. Replacement O-rings are supplied with each vaporizer. A, CAUTION Step 4 Install the vaporizer into the manifold + 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. 1107-0641-000 1/2401 ‘wronizen wreRLOcK BLOCK PORT ENSU PLUS REMOVED RENEW MANIFOLD PORTVALVE GING, Tr NECESSARY” SS, t x1 Setup and Mounting Procedure \aronizen WwTERLOCK —— ato PORT ENSURE = PLUGS REMOVED ‘RENEW MANIFOLD _- PORT VAVE O-ANG I NECESSARY Figure 4-8 + Readying the manifold To ease the routing of the power cord, the Tec 6 Plus Vaporizer must be mounted onto the far right-hand side of the manifold for Excel and Modulus machines. For other machines, refer to their manuals. Figure 4-9 + instaling the vaporizer 47Tec 6 Plus Vaporizer A CAUTION Step 5 Lock the vaporizer onto the manifold. ‘+ Push the locking lever D down all the way. + Turnit clockwise ® to the locked position @ to tock the vaporizer onto the manifold, Push the locking lever down all the way before attempting to turn it. The mechanism can be damaged if an attempt is. made to tum the lever before it is at the full extent of its vertical travel. ust Down @ voraeearay® @® Tun cLocewise Loca Lever @ tocneo tocawa tev — Figure 4-10 * Locking the vaporizer ‘vesio11107-0641-000A WARNING Step 6 Route the power cord. * Route the power cord around the right-hand side of the anesthesia machine as viewed from the front. * Referto the Aestiva ‘manual if mounting vaporizer on an Aestiva. Step 7 Ensure that the vaporizer is correctly mounted (see Checking the vaporizer for correct mounting). 1107-0641-000 129/01 Setup and Mounting Procedure Do not route the power cord over the top of the Selectatec™ Series manifold. To do so may affect the correct functioning of the Tec 6 Plus Vaporizer and/or any other vaporizer. sie suPpORT } | 74 7 ves cmon ‘AROUND THE Side Surpoer ao To “WEREAR OF THE | AST ace a 7 OAR Figure 4-11 + Routing the power cord ») oan Figure 4-12 + Checking the vaporizer mounting 49Tec 6 Plus Vaporizer Checking the vaporizer for correct mounting 4. WARNING —Tohelp to 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. I more than one vaporizer is fited, visually check to make sure that the tops of the vaporizers are horizontal. If the vaporizer is visibly out of line, perform steps 3 and 4 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 lft the vaporizer straight up from the mani fold. f the vaporizer can be lifted off the manifold, itis not correctly mounted. Remount the vaporizer (see Vaporizer mounting Proce- dure). ‘2901 1107-0641-000Setup and Mounting Procedure Removing the vaporizer from a manifold Only an individual trained in the servicing of NAD anesthesia equipment can remove a vaporizer from a North American Drager (NAD) machine. A. WARNING ‘This procedure applies only to the Datex-Ohmeda vaporizer. Step 1 Set the dial to ©. Figure 1-13 + Setting the ala Step 2 Disconnect the vaporizer from the AC power supply. 1107-0841-000 2/16/01 anTec 6 Plus Vaporizer Step 3 Unlock the locking lever. fo reverse + Tum the locking lever umn scum counter-clockwise O. iommer + Release the locking lever aa ® and check that the locking lever springs up to the unlocked position @ to release the vaporizer from the manifold. LocKins @ unLocKeo then Figure 4-14» Unlocking the locking lever Step 4 Carefully lift the vaporizer up from the manifold. Figure 4-15 « Liting the vaporizer ae vesi01 1107-0641-000Operating Instructions In this section Alarm and display test. Preoperative checkout. Setting the dial. Filing the vaporizer. Filling procedure... 1107-0641-000 1/23/01 54Tec 6 Plus Vaporizer Alarm and display test A, WARNING A, CAUTION Step 1 Connect the power cord from the vaporizer to an approved hospital grade outlet socket. A WARNING Step 2 Verity that the alarm and display test for a period of approximately four seconds as follows: ‘+ Each light and all the LCD agent level indicator bars ‘on the front display panel flash ©The auditory alarm is activated. 52 Only use vaporizers that are in a serviceable condition. Before connecting the vaporizer to an AC power supply, be sure it is within the ambient operating temperature range (see Performance in Chapter 9). Do not use the vaporizer if during the alarm and display test any one of the five lights and all the LCD agent level indicator bars do not flash or the auditory alarm does not operate for a period of approximately four seconds. DESFLURANE ~ orenarona, \wtuy wy Wourrur NA - Flashes eo ~waeur “ie Figure 5-1 + Ventying the alarm ‘vesio1 1107-0641-000Step 3 Ifthe LOW AGENT light remains illuminated after the alarm and display test is completed, fill the vaporizer as described in Filling the vaporizer, 1107-0681-000 1/23/01 Operating Instructions DESFLURANE Fenn ae Ne “owaceet vi « fenrice — Ll Figure 5-2 + Filling the vaporizer 53Tec 6 Plus Vaporizer Step 4 If there is sufficient agent in the sump, check that each light is extinguished, except the amber WARM-UP light which indicates that the vaporizer is in its warm-up condition. If the vaporizer is warm before it is connected to the electrical supply, the green OPERATIONAL light may illuminate immediately. Step 5 After a warm-up period of up to 410 minutes check that the amber WARM-UP light extinguishes and the green OPERATIONAL light illuminates to indicate that the vaporizer is ready for use. If the OPERATIONAL light does not illuminate within 10 minutes, refer to the Troubleshooting guide in Chapter 8 Step 6 The alarm and indicators can be tested at any time by pressing PW for at least three seconds to activate the alarm and display test. Activating the test does not affect the operation of the vaporizer. DESFLURANE Figure 5-3 » Checking Warm-up light DESFLURANE Approx. —> m= ten minutes Us ace Figure 5-4 « Checking Operational ight > 3 sec = Alarm test Figure 6-5 + Testing alarm 1ve81011107-0641-000Operating Instructions Preoperative checkout Step 1 Test the vaporizer for leaks. * The Tec 6 Plus Vaporizer canbe postive pressure or negative pressure leak tested, _© Leak test + Perform the leak test as described in the relevant anesthesia system's operation and maintenance manual initially with the dial at © (@). Repeat the test with the vaporizer dial turned to the 1% setting (@) and then tum the dial to the © @ seting (®) _-1% Leak test Figure 5-6 + Testing for leaks 1107-0641-000 1/2401 55Tec 6 Plus Vaporizer Step 2 Check the battery 58 Check the amber ALARM BATTERY LOW light. Ifthe lights illuminated, ft anew battery as described in Changing the battery in Chapter 6. Check that the light extinguishes. DESFLURANE MWe Me tirenriow el Figure 5-7 + Checking the battery vesi01 1107-0641-000Step 3 Test the vaporizer output alarm, + Tur the dial to a setting of 1% of above. * Unplug the power cord from its outlet socket. + Wait for at least 15 ‘seconds and then check that both the auditory alarm and the red NO OUTPUT light are activated, + Ifthe alarm and light are not activated, do not use the vaporizer. 1107-0681-000 v2w01 Operating Instructions Figure 5-8 + Testing the output alarm 57Tec 6 Plus Vaporizer Step 4 Reconnect power tothe vaporizer + When the alarm and ight are activated, tum the dial totheO setting + Reconnect the power cord. * ~~ Check that the alarm and display test is activated. ~N DESFLURANE 7 [p om Z a Flashes eae Riad i wy u Figure 5-9 + Reconnecting the vaporizer 58 ‘29101 1107-0641-000Step 5 ‘When the green OPERATIONAL light illuminates, the vaporizer is ready for operation. 1107-0641-000 1/23/01 Operating Instructions DESFLURANE WE 8 . < oe MY Figure 5-10 + Checking the Operational ight 59Tec 6 Plus Vaporizer Setting the dial A WARNING Important High percent dial settings combined with low gas flows may lead to hypoxic mixtures within the breathing circuit. Datex-Ohmeda strongly recommends the use of oxygen monitoring. The dial release must be operated to turn the dial from the © setting and also to increase the dial setting to above 12%. Do not operate the dial release when turing the dial to any other setting, it may result in overriding the 12% stop and causing an inadvertent delivery in excess of 12%. The vaporizer has not been calibrated at any dial setting between © and 1%. Do not use the vaporizer at dial settings between © and 1%. Itis a requirement of European Standard EN 740 - Anaesthetic Work- stations And Their Modules, that the gas monitoring device referred to in What is a Tec 6 Plus Vaporizer? in Section 2 of this manual is in op- erating condition, by being enabled and functioning, prior to use of the vaporizer. Datex-Ohmeda strongly recommends the use of anesthesia gas mon- itoring with this equipment. Refer to local standards for mandatory monitoring 31901 1107-0641-000Operating Instructions Step 1 Press the dial release and tum the dial in a counter-clockwise direction from the O setting, Figure §-11 + Releasing the ofa! Step 2 Release the dial release and tum the dial to the required percentage setting. Figure 5-12 « Dialing the required percentage Step 3 Check that when the vaporizer dial is turned from ©, no other vaporizer mounted on the same manifold can be tumed on. 1107-0641-000 1/23/01 oatTec 6 Plus Vaporizer Step 4 Tum the dial to the © setting and check that the dial release springs out. The vaporizer will remain in standby ©, ready for further Use if required, unti the electrical supply is disconnected. Figure 5-13 « Setting dial to standby 512 ‘yesio11107-0641-000Operating Instructions Filling the vaporizer A, WARNING 1107-0641-000 1/2301 Do not fill the vaporizer with any substance other than Suprane™ (desflurane). If any substance other than ‘Suprane™ (desflurane) is used, patient injury could occur. When the vaporizer is in use, do not fll the vaporizer if the following conditions apply: * The dial setting is more than 8% at flows of 8 liters/minute or above. * The vaporizer is subjected to any high back pressure +The Suprane™ (desflurane) has been refrigerated or chilled below 18 °C. Failure to comply with this waming may result in a temporary decrease in delivered concentration and activate the NO OUTPUT alarm. Only fill the vaporizer when it is in an upright position. Failure to do so may result in the vaporizer being over filled. Only fil the vaporizer when it is connected to the electrical supply. This enables you to observe the agent level display. Do not attempt to fill the vaporizer when the level display indicates that it is full. 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. 513Tec 6 Plus Vaporizer Filling procedure Step 1 Remove the bottle cap from the Suprane™ (desflurane) bottle and ensure that the O-ring is correctly fitted to the bottle probe. 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. When filing the Tec 6 Plus Vaporizer, observe the following + The vaporizer must only be filed when it is in an upright position, ‘+The vaporizer sump can be filled when the vaporizer isin its WARM-UP cycle or at any time the vaporizer is in use except ‘as noted in the warning. If the vaporizer isin its OPERATIONAL condition, the time taken for the agent to flow into the vaporizer may be increased. + Only agent bottles with a Saf-T-Fill™ bottle probe specific to ‘Suprane™ (desflurane) should be inserted into the filler port. BOTTLE CAP. Figure 5-14 + Removing the bottle cap ‘v23i011107-0841-000Step 2 Insert the bottle probe into the filer port and then push the bottle firmly against the spring pressure until itis fully engaged in the filler por. A WARNING Step 3 Lift the bottle upwards. Ifthe bottle cannot easily be lifted, it may be because the bottle has not been completely inserted. 1107-0681-000 1/29/01 Operating Instructions ENSURE BOTTLES FULLY ENGAGED FLLER PORT Pusu sore Femty To FILLER PORT Figure §-15 + Loading the bottle Ensure that the bottle probe is fully engaged into the filler port before attempting to lift the bottle. If the bottle cannot easily be lifted, do not force it, otherwise the valve can be broken. Figure 5-16 * Liting the bottleTec 6 Plus Vaporizer Step 4 Fill the vaporizer. 516 When the bottle moves easily, lock the bottle in the upper position. When the bottle reaches the upper stop, the agent bubbles for up to 45 seconds before it flows from the bottle through the filer port into the vaporizer sump. Hold the bottle in position at the upper stop and fill Until the bottle is empty or the indicator on the display panel indicates that the ‘sump is ful. sone ATUPPER STOP = Z\ Figure 5-17 + Filing the vaporizer sveaion 1107-0641-000A, WARNING Step 5 Drain the bottle and remove. * Grip the bottle firmly and lowerit from the upper stop position to the lower stop position + When the bottle reaches the lower stop position, hold the bottle firmly in the filer port for at least five seconds to allow the small amount of agentin the filer system to drain back into the bottle. + To avoid dropping the bottle, suppor the bottle as itis automatically unlocked from the filler port and released from the fille. Note: Do not twist the bottle as you pull the bottle out +The valve on the bottle automatically closes to help avoid loss of agent. 1107-0841-000 1/2101 Operating Instructions Grip the bottle firmly while rotating it downwards from the upper stop position to the lower stop position and hold the bottle firmly in the filler port until the small amount of agent in the system has drained back into the bottle. Failure to do so may result in spilling agent. 5 sec Figure 5-18 » Removing the bottle sarTec 6 Plus Vaporizer This page left blank intentionally 1resio1 1107-0641-000Maintenance In this section Maintenance intervals Cleaning. External cleaning. Internal contamination ‘Output concentration check, Changing the battery... Spare parts. et 1107-0641-000 2/1501Tec 6 Plus Vaporizer User Maintenance Maintenance Intervals Cleaning A WARNING External cleaning A WARNING 62 Prior to performing any maintenance procedures or returning to a service center for repairs, clean and disinfect the vaporizer. ‘Annually: Battery replacement. Two years from Planned safety inspections together with the purchase date and anesthesia system by qualified personnel. Syery gx months inspect and perform Output concentration check. Do not put any substance other than Suprane™ (desflurane) into the vaporizer sump. Do not immerse the vaporizer in water or any other liquid. Do not autoclave the vaporizer. Do not allow cleaning agents to accumulate in the filler, the gas inlet and outlet ports or around the control dial. To clean external surfaces, use a moist cloth and a detergent (pH 7 to 10.5). For disinfection purposes, cleaning agents of a surface germicide type should be used. In terms of material compatibility, cleaning agents which contain the following active ingredients are suitable for use: + Aldehydes, + Alcohol, * Quaternary ammonium compounds. To avoid possible damage to the vaporizer, do not use the following compounds as cleaning agents: Halogen hydrolyzing compounds, Strong organic acids, + Oxygen hydrolyzing compounds. 329101 1107-0641-000Internal contamination Output concentration check 1107-0641-000 2/15/01 Maintenance It the vaporizer is filled or partly filled with an incorrect volatile agent or other contaminant, proceed as follows: 1. Remove the vaporizer from service immediately and label the va- porizer stating that itis contaminated. 2. Retum the vaporizer to the Datex-Ohmeda Authorized Service Center stating that the vaporizer is contaminated and, if possible, the type of contaminant in the vaporizer. Connect the Tec 6 Plus to Anesthesia Machine, 1. Set the oxygen output of the anesthesia machine to a flow of = 0.5 Umi 2. Ensure that the fresh gas output is connected to a gas scavenging system. 3. Measure the concentration at the fresh gas outlet, using an agent monitor which is calibrated to measure desflurane. 4, Allow the readings to stabilize and check that the readings are within specified tolerances. 5. Documentand maintain the test results, including the date, person Performing the test, and serial number of the unit tested The accuracy of the measuring equipment must be considered when obtaining the readings! Dial Setting Min Vol % Max Vol %. 1 5 1.50 6 5.10 6.90 12 10.20 13.80 18 15.30 20.70 63Tec 6 Plus Vaporizer Changing the battery Change the battery every 12 months, irrespective of condition. Step 1 Tum the dial to © Figure 6-1 + Setting the dial to standby Step 2 Disconnect the power cord from the electrical supply. Step 3 Remove the battery cover Me coe + Remove the vaporizer trom the manifold of the anesthesia system as described in Removing the vaporizer from a manifold in Chapter 4 and invert the vaporizer. ‘+ Unscrew the battery cover securing screw. ‘+ Remove the battery cover. vaponzeR — vente Figure 6-2 + Removing battery cover 64 2NS101 1107-0641-000Step 4 Remove the battery and disconnect the terminals. Dispose of the battery according to local regulations. A, CAUTION A WARNING Step 5 Install a new battery. + Clip the battery terminals firmly onto the new battery, observing the correct polarity + Insert the battery into the vaporizer. 1107-0641-000 2/18/01 Maintenance Figure 6-3 + Removing the battery Install only a Duracell MN1604 or VARTA Energy 2000 nine volt battery in the vaporizer. If any other battery is installed, it can damage the vaporizer. The battery terminals must be firmly clipped onto the battery to help prevent a possible disconnection when the vaporizer is moved. sarreny TERMINALS DURACELL MN 608 08 ‘ARTA ENERGY 2000 barren Figure 6-4 « Installing new battery 6568 Tec 6 Plus Vaporizer Step 6 Fit the battery cover to the base of the vaporizer and tighten the securing screw. 4 WARNING fxrreny coveR SecURIG SCREW — Figure 6-5 + Replacing battery cover Do not throw batteries onto a fire, do not open with force and do not recharge. To do so may result in operator injury. When disposing of batteries, treat them as special waste and dispose of according to local regulations. ‘vaaios 1107-0641-000Spare parts 1107-0661-000 ‘veaio1 Maintenance Description Part No. (O-ring Kit 1104-3025-000 Battery 1370219 NAD Mounting Kit 1107-7097-000 Power Cords: Aestiva (universal) 5m 1006-3796-000 IEC 320 1.5m 1107-3191-000 North America 3.5m 1107-3189-000 North America 1.5m 1107-3190-000 Continental Europe 1.5m 1007-3186-000 Continental Europe 3.5m 1107-3185-000 United Kingdom 3.5m 1107-3187-000 Australia/New Zealand 1.5m 1107-4020-000 Australia/New Zealand 3.5m 1107-4025-000 To order contact your Datex-Ohmeda customer service representative. e7Tec 6 Plus Vaporizer oa This page left blank intentionally. veaio1 1107-0641-000Principle of Operation In this section Alarm and indicator display. Delivery of gas/agent vapor nnn TB 7-2. 1107-0681-000 1/23/01 7aTec 6 Plus Vaporizer Alarm and indicator display See Figure 7-1 1 ‘When the electrical supply is connected, each light and each LCD agent level display bar on the front display panel (17) flashes and the auditory alarm activates to indicate that the alarms are opera- tional. After approximately four seconds, each light is extin- guished, the LCD bars stop flashing and the auditory alarm is silenced, The amber WARM-UP light is illuminated to indicate that the va~ porizer is in its warm-up cycle and the LCD agent level display bars indicate the amount of agent in the sump. During the warm-up cycle, the shut-off valve (8) is closed to pre- vent the supply of vapor to the pressure regulating valve (7), and the electronics (16) perform the zero check. ‘When the vaporizer attains the required operating temperature, the amber WARM-UP light is extinguished and the green OPER- ATIONAL lightilluminates to indicate that the vaporizer is ready for use. Delivery of gas/agent vapor A 72 When the vaporizer is ready for use, a signal from the electronics (16) operates the solenoid (19) in the interlock mechanism which allows the dial and rotary valve (1) to be tured. When the dial and rotary valve (1) are tuned, a signal from the electronics (16) opens the shut-off valve (8). ‘The pressure control transducer (3) sends a signal ofthe aiffer- ence between the gas inlet pressure and the regulated agent pres- ‘Sure to the electronics (16). The electronics alters the regulated agent pressure by opening or closing the pressure regulating valve (7) to balance the pressures. When the regulated agent pressure of the circuit is equal to the {gas inlet pressure, the vaporizer functions correctly. ‘The dial and rotary valve (1) regulates the volume of vapor being delivered to the fresh gas mixture. ‘The fresh gas mixes with the vapor just prior to the gas/agent out- let in the proportions consistent with the selected dial setting, 129101 1107-0641-000Principle of Operation 1” Fresh Gas Inlet iB oll EY TO COMPONENTS. Figure 7-1 + Vaporizer schematic 1107-0641-000 1/23/01 73Tec 6 Plus Vaporizer 74 This page left blank intentionally ‘vesion 1107-0641-000Troubleshooting In this section Troubleshooting guide...... 8-2 1107-0641-000 1/2301 etTec 6 Plus Vaporizer Troubleshooting guide The following table details the alarm condition and the actions which must be performed to correct the alarm condition and the possible cause, If vaporizer fails to function correctly after the appropriate action has been taken, send the vaporizer to the Datex-Ohmeda Authorized Ser- vice Center for repair. Not Ifthe dial is at the © setting when an alarm occurs, the auditory alarm does not repeat Vaporizer Status Action depressed, but the dial will not dial stil cannot be turned. The vaporizer dial release can be turn. When more pressure on the dial release is applied, a click on the mechanism is detected. The Let go of the dial release, then: until the green OPERA- TIONAL light illuminates. b) If another vaporizer is in use, to OFF/ ©. a) Allow the vaporizer to warm up tum the other vaporizer to dial a) During WARM UP, the interlock mechanism pre- vents vaporizer use. b) The interlock mechanism of another vaporizer is operative. Alarm indication Action Possible cause qui Turn the dial to ©). Restore external power. The vaporizer may go to operational or pertorm a thorough system check before going operational, depending on time of external power restoration, or permanently ted alarm if an internal power failure is detected. Note that a power failure causes the higher pitched auaio alarm tone. Tum the dial to © and level the vaporizer. AX WARNING Use an alternative means of anesthesia. Power failure. Tit Any internal malfunction. 22 ‘veaio11107-0641-000Troubleshooting Guide Alarm indication Action Possible cause Fill the sump with Suprane™. ‘Agent level <60 mi. 4. WARNING If this condition persists until there is less than 20 ml of agent in the sump, the NO OUTPUT alarm is activated and the output ceases. uy vt Turn the dial to ©) and fill the sump with Suprane™. 4X WARNING If the NO OUTPUT alarm persists, use analternative means of anesthesia. ‘Agent level <20 mi. Change the battery as soon as. practical (ideally within eight hours of alarm indication) ‘Alarm battery low. 1107-0641-000 ‘v2aion 23Tec 6 Plus Vaporizer Alarm indication Action DESHLUA 4. WARNING Do not attempt to use the vaporizer, Ifthe amber WARM-UP light does not extinguish within ten minutes after the vaporizer is connected to an electrical supply, there may be an internal maifunction. a4 ‘veaio1 1107-0641-000Specifications In this section — Calibration...... Electrical supplies ... Performance.. Classification ..... Weight and dimensions Flow characteristics... Effects of output at varied altitudes M Effects of ambient temperature. Effects of back pressure..... Effects of carrier gas composition 1107-0641-000 1/23/01 onTec 6 Plus Vaporizer Calibration A WARNING Electrical supplies 92 Note: All specifications are nominal and subject to change without notice. Check the calibration certificate that is included with your Tec 6 Plus Vaporizer. The Tec 6 Plus Vaporizer can only be calibrated at a Datex-Ohmeda Authorized Service Center. The Tec 6 Plus Vaporizer is calibrated at 760 torr and at a nominal 21 °C for the following concentrations (v/v percent): 1, 2, 3, 4,5, 6, 7 8, 9, 10, 12, 14, 16 and 18, using O, as the carrier gas flowing at five liters/minute. 100 to 120V AC 50/60 Hz or Voltage requirement 220 to 240V AC 50/60 Hz Current input ‘Maximum current requirement is 2.0 A Power consumption : 250 VA nominal ‘The ~ symbol on the vaporizer rating label denotes that the external AC power supply must be single phase sinusoidal alternating current. ‘veaiot 1107-0641-000Performance Specifications Concentration range 1 to 18% Scale 1% from 1 10 10% 2% from 10 to 18% Calibrated flow range at21 22°C 0.2 to 10 liters/minute ‘Accuracy at 5 liters/ min Op + 0.5% vv of delivered agent or + 15% dial setting (whichever is greater) Liquid capacity 390 mi nominal volume (indicated on level display) 240 ml refill capacity indicator nominal 60 ml reserve (not indicated on level display) Flow resistance Less than 50 cm HO at 5 liters/minute of Op at21 °C Less than 250 cm HO at 15 liters/minute of Op at 21°C Battery ‘Operating temperature range Duracell MN 1604 or VARTA Energy 2000 18 °C to 30°C (64 °F to 86°F) ‘Operating humidity range ‘30% to 75% relative humidity (non-condensing) ‘Storage temperature range -40 °C to 60°C (-40 °F to 140°F) Storage relative humidity range (0% to 95% relative humidity at 40 (non-condensing) ‘Storage atmospheric pressure 70.0 to 106.0 kPa 1107-0641-000 29/01 osTec 6 Plus Vaporizer Classification os The vaporizer can be powered indefinitely unless a fault condition oc- curs, also known as continuous rating. ‘Type of protection against electric shock is Class 1. Accessible con- ductive parts of Class 1 equipment are connected to a protective earth in such a way that they do not become live in the event of a failure of the basic insulation The J symbol onthe vaporizer rating label denotes the degree of protection against electric shock, which is Type B. The vaporizer is not protected against liquid flowing into the interior of the unit ‘veaio11107-0641-000Specifications Weight and dimensions Datex-Ohmeda Weight 9.5 kg 20 Ib 15 02 (empty) Depth 235 mm 9 1/4 inches Width 110 mm ‘4.3/8 inches Height 250 mm 97/8 inches (in the unlocked position) North American Drager Weight 10kg 22 lb (empty) Depth 235 mm 9 1/4 inches Width 110 mm 43/8 inches Height 235 mm 9 1/4 inches 1107-0641-000 1/29/01 osTec 6 Plus Vaporizer Flow characteristics ‘The graph shows the nominal output of the Tec 6 Plus Vaporizer at 760 torr Effect Of Flowrate At 21 deg. C. DIAL SETTING 4 ‘DESFLURANE OUTPUT FLOW (UTERSMUNUTE 0) os ‘veaio1 1107-0681-000Effects of output at varied altitudes The Tec 6 Plus Vaporizer is calibrated in percent viv and the calibra~ tion is not affected by ambient pressure changes. The partial pressure of the delivered agent at any selected dial setting varies directly with the changes in ambient air pressure. The required dial setting can be calculated using the following formula: Required Dial Seting = Normal Dial Setting %e viv x Specifications 760 torr ambient pressure (OT) The table below shows the dial setting on a Tec 6 Plus Vaporizer at altitudes of 1000m and 200m respectively above sea level: Required dial setting percent Normal bein At an altitude of ‘At an altitude of 000m (3262 feet) | 2000m (6564 feet) 3 35 6 70 1 125 14 17 18 Effects of ambient temperature Effects of back pressure 1107-0641-000 e301 The performance of the Tec 6 Plus Vaporizer is not significantly affect- ed by the temperature variations within the operating range specified in Performance. Fluctuating back pressure does not significantly affect the output of the Tec 6 Plus Vaporizer. Steady back pressure does not significantly affect the concentration of the agent delivered (viv), but does increase partial pressure of the agent. The increase is in the ratio of total back pressure to the vapor- izer calibration pressure of 760 torr. o7Tec 6 Plus Vaporizer Effects of carrier gas composition ‘Small output decreases can occur when the carrier gas composition is. ‘changed from 100% oxygen. ‘When either air or nitrous oxide is employed as the carrier gas, the out- Put is lowered compared to the output when oxygen is the carrier gas. This effect is the greatest (up to 20% of setting) at low flows when ni- {ous oxide is employed, but using nitrous oxide reduces the required inspired concentrations of volatile agent which can, depending upon the proportion, mitigate the decreases in output from the vaporizer. 98 ‘yeaio11107-0881-000Warranty In this section — warranty.. 1107-0641-000 1/2301 104Tec 6 Plus Vaporizer Warranty 102 ‘This product is sold by Datex-Ohmeda under the warranties set forth in the following paragraphs. ‘Such warranties are extended only with respect to the purchase of this, Product directly from Datex-Ohmeda or Datex-Ohmeda’s Authorized Dealers as new merchandise and are extended to the first Buyer thereof, other than for purpose of resale. For a period of twenty-four (24) months from the date of original deliv- ery to the first Buyer or to Buyer's order, but inno event for a period of more than two years from the date of original delivery by Datex-Ohm- eda to a Datex-Ohmeda Authorized Dealer, this Product, other than its ‘expendable parts, is warranted against functional defects in materials, land workmanship and to conform to the description of the Product contained in the Operation and Maintenance manual and accompany- ing labels and/or inserts, provided that the same is properly operated under conditions of normal use, that regular periodic maintenance and service is performed and that replacements and repairs are made in accordance with the instructions provided. This same warranty is, ‘made for a period of thity (30) days with respect to expendable parts. The foregoing warranties shall not apply if the Product has been re- paired other than by Datex-Ohmeda or other than in accordance with written instructions provided by Datex-Ohmeda, or altered by anyone other than Datex-Ohmeda, or ifthe Product has been subject to abuse, misuse, negligence, or accident. Datex-Ohmeda's sole and exclusive obligation and the Buyer's sole and exclusive remedy under the above warranty is limited to repairing or replacing, free of charge, at Datex-Ohmeda’s option, a Product which is confirmed as being defective by Datex-Ohmeda following the Buyer's notification to Datex-Ohmeda and, where requested, return of the Product to Datex-Ohmeda in accordance with the instructions con- tained in the Servicing Policy section of the O & M Manual, not later than seven (7) days after the expiration date of the applicable warran- ty. Datex-Ohmeda shall not be otherwise liable for any damages in- Cluding but not limited to incidental damages, consequential damages, or special damages. There are no express or implied warranties which extend beyond the warranties herein above set forth. Datex-Ohmeda makes no warranty of merchantability or fitness for a particular purpose with respect to the Product or parts thereof. ‘vesio1 1107-0641-000Servicing Policy In this Section — Servicing policy ..niunnnnmnasnns 11-2 1107-0641-000 1/2401 naTec 6 Plus Vaporizer Servicing policy 112 Repairs and service procedures must be performed at a Datex-Ohm- eda Authorized Service Center. Contact your Datex-Ohmeda Service Representative or Datex-Ohmeda Authorized Distributor. I you are shipping the unit to the nearest Datex-Ohmeda Field Oper- ations Unit, package the vaporizer and power cord securely for protec- tion in its original packaging, and ship it prepaid. Provide the following items 1. Details of any difficulties experienced with the equipment. 2. Warranty information such as a copy of the invoice or other docu- mentation 3. Purchase order number to cover repair or service of equipment not under warranty. 4. Ship to and bill to information. The name and telephone number of the person to contact. 4v231011107-0641-000A Accuracy 9-3 Agent concentration 3-3 Agent level display 3-5, 3-8 Agent level indicator 5~ Agent level sensing probe 2-9 Agent level sensor 2-8, 2-9 LCD 2-9 Alarm and display test 5-2 Alarm and indicators test 5-4 Alarm battery low 3-11 Alarm Levels 3-6 Alarm levels High 3-6 Low 3-6 Medium 3-6 Ambient operating temperature 5-2 Auditory alarm No output 2-9 Test 5-2 Auditory alarm mute button 3-4, 3-5 Auditory signals 3-6 Back pressure 9-7 Battery 2-5, 9-3 Changing 6-4 Disposing 6-6 Frequency of replacement 2-7, 6-4 Installing 4-2, 4-3, 6-5 Removing 6-5 Replacement type 4-2, 6-5 Terminals 4-3, 6-5 Testing 5-6 Battery cover Removing 4-2, 6-4 Securing screw 4-2, 4-3, 6-4, 6-6 Bottle Lower stop position 5-17 Upper stop position 5-16 Breathing tubes 2-4, 5-14 1107-0641-000 1/24/01 Index c Calibrated flow range 9-3 Calibration 9-2 Carrier gas composition 9-8 Concentration range 9-3 Concentration, setting 3-3 Condensation 2-8 Current input 9-2 Cyclopropane 2-4, 5-13 D Datex-Ohmeda Authorized Distributor 11-2 Datex-Ohmeda Field Operations Unit 11-2 Datex-Ohmeda Service Representative 14-2 Depth 9-5 Desflurane 1-3, 2-2, 2-6, 5-13, 5-14 Refrigeration 5-13 Dial 3-3 Setting 5-10 Dial release 3-3, 5-11 Drain plug 2-7 E Electrical supplies 9-2 Equi-potential stud 2-8 Ether 2-4, 5-13 F Face masks 2-4, 5-14 Filler assembly 2-6 Filler port 5-15 Filling the vaporizer 5-14 Flow resistance 9-3 Front panel display 3-5Index H Heater elements 2-8 Height 9-5 High frequency surgical apparatus 2-4 High frequency ventilation 2-5 Hospital grade outlet 5-2 Interlock block ports 4-7 Interlocks 2-3, 3-3, 4-5, 4-6 L Leaks, testing for 5-5 Lights Alarm battery low 3-5, 5-6 Amber 3-6 Continuous 3-6 Flashing 3-6 Low agent 3-5 No output 2-9, 3-5, 5-7 Operational 3-3, 3-5, 3-8 Red 3-6 Test 5-2 Warm-up 3-5, 3-7 Liquid capacity 9-3 Lock lever 3-4 Locking lever 4-6, 4-8 Locking vaporizer onto manifold 4-8 Unlocking vaporizer from manifold 4-12 Magnetic Resonance Imaging 2-4 Manifold 4-7 Manifold port valve O-ring 4-5, 4-7 Manifold port valves 4-7 Mercury, use in Tilt switch 2-4 Monitors Agent volume 2-8 Pressure balance 2-8 Mounting Checking for correct mounting 4-10 Mounting procedure 4-5 N No output 3-10 fo} Operating humidity range 9-3 Operating temperature range 9-3 Output alarm, testing 5-7 Oxygen monitoring 5-10 P Power consumption 9-2 Power cord 2-7, Installing 4-2, 4-4 Routing 4-2, 4-7, 4-9 Power cord channel 4-4 Power cord retaining plate 4-4 Power failure 3-10 Power supply unit 2-6 Preoperative checkout 5-5 Principle of operation 7-1 Alarm and indicator display 7-2 Delivery of gas/agent vapor 7-2 R Refill mark 3-5 Removing the vaporizer from a manifold 4-11 1107-0841-000 1/2401