Operator s Manual Product Name TEC -II Here Tissue Embedding Center Catalog # TEC2120

Transcription

1 Histology Innovation for a NEW Generation Pub No.: OM TEC March 2014 TEC2120 Operator s Manual Product TEC -II Name Here Tissue Embedding Center Catalog # TEC2120

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3 Copyright 2009 General Data Company. All rights reserved This document may not be copied in whole or in part or reproduced in any other media without the express written permission of TBS-A Division of General Data Healthcare, or General Data Healthcare. Please note that under copyright law, copying includes translation into another language. General Data Healthcare TBS-A Division of General Data Healthcare Corporate Headquarters 3014 Croasdaile Road 4354 Ferguson Drive Durham, NC Cincinnati, Ohio Tel Tel Fax Fax User Resources and Customer Support Contact your TBS representative for customer support. For the latest information on TBS products and services, please visit the TBS website at: Scope This document contains basic information on the use and operation of the TEC -II Tissue Embedding Center, and assumes you have received basic training on the instrument. Please contact your TBS representative for information not provided in this manual. Intended Use Before operating the instrument, please read these instructions carefully to familiarize yourself with its proper operation and functions. The -TEC -II is a highly efficient tissue embedding center designed to embed paraffin-infiltrated tissue in paraffin. Only skilled or specially trained personnel must operate the instrument. The marked safety measures as well as the regulations of your respective lab must strictly be observed. Installation Procedure The TEC -II must be installed, and instrument performance is to be verified, at the customer site by trained TBS representatives. Disclaimers This manual is not a substitute for the detailed operator training provided by TBS, or for other advanced instruction. A TBS representative should be contacted immediately for assistance in the event of any instrument malfunction. Page 3

4 Instrument Compliance TBS A Division of General Data Healthcare, Inc. hereby declares the equipment specified conforms to the Classifications(s), Directives(s), and Standard(s) set forth in this document. Certifications: CE, UL/CSA Page 4

5 Operator Controls 1 The paraffin flow rate can be adjusted by turning the knob Storage for hot paraffin 2. Left-hand chamber 3. Right-hand chamber 4. Dispensing nozzle 5. Forceps Warmer 6. Cold zone 7. Keypad and display for programming and control 8. Waste trays 9. Cryo Console 10. Connector for auxiliary heated forceps Page 5

6 Table of Contents Copyright 2009 General Data Company. All rights reserved... 3 Instrument Compliance... 4 Operator Controls... 5 Declaration of Conformity... Section 1 Safety... 8 Safety Devices... 9 Section 2 Specifications... 9 Technical Specifications... 9 Section 3 Preparation/Installation Unpacking Instrument Connecting the TEC -II Section 4 Operation Start Up and Programming Keypad Selecting Operating Parameters Programming Date and Time Temperatures Automatic Start up/shutdown Programming Pauses Section 5 Cleaning & Maintenance Daily Cleaning Maintenance Fuse Replacement Troubleshooting Alarm Messages Page 6

7 Declaration of Conformity Konformitätserklärung Déclaration de conformité Declaración de Confomidad Verklaring de overeenstemming Dichiarazione di conformità We/Wir/ Nous/WIJ/Noi TBS-A Division of General Data Healthcare Declare under our sole responsibility that the product, erklären, in alleniniger Verantwortung,daß dieses Produkt, déclarons sous notre seule responsabilité que le produit, declaramos, bajo nuestra sola responsabilidad, que el producto, verklaren onder onze verantwoordelijkheid, dat het product, dichiariamo sotto nostra unica responsabilità, che il prodotto, TEC -II Tissue Embedding Center to which this declaration relates is in conformity with the following standard(s) or other normative documents. auf das sich diese Erklärung bezieht, mit der/den folgenden Norm(en) oder Richtlinie(n) übereinstimmt. auquel se réfère cette déclaration est conforme à la (aux) norme(s) ou au(x) document(s) normatif(s). al que se refiere esta declaración es conforme a la(s) norma(s) u otro(s) documento(s) normativo(s). waarnaar deze verklaring verwijst, aan de volende norm(en) of richtlijn(en) beantwoordt. a cui si riferisce questa dichiarazione è conforme alla/e seguente/i norma/o documento/i normativo/i Page 7

8 Section 1 Safety To avoid injury from electrical current, the instrument must be connected with the protective earth. The instrument is equipped with a three wire ground plug. The power outlet must be connected to the protective earth and must meet the International Electrotechnical Commission (IEC) regulations Never remove instrument housing during operation. Component replacements as well as adjustments must only be made by trained service personnel. Only use original spare parts for replacement work. Unplug the unit before removing or opening the covers The instrument must not be operated in the presence of flammable gases. Moreover, the instrument must not be exposed to conditions whereby dangerous gas concentrations can occur. When working with radioactive specimens observe all applicable radiation safety procedures. When working with radioactive contaminated material, appropriate safety and disinfecting measures must be carried out. According to the rules and regulations concerning the handling of radioactive contaminated material of the respective laboratory, safety clothing (e.g. particle mask, gloves, protective shoe covers) must be worn. Radioactive contaminated waste must be disposed of according to the respective regulations. All containers in instrument are only suitable for paraffin and not for any other inflammable material. Due to the fact that work might be hazardous because of freezer burns on frozen parts, the TEC -II should be only operated by skilled or well-trained lab personnel. We recommend to wear protective gloves Specimens used during the intended operation of the instrument might potentially be infectious. For this reason, it is recommended to observe the general laboratory regulations concerning protection against danger of infection. Information on decontamination media, their use, dilution and effective range of application can be read in the Laboratory Biosafety Manual:1984 of the World Health Organization. When working with infectious specimens observe all applicable safety procedures. When working with infectious material, appropriate safety and disinfection measures must be carried out. According to the rules and regulations concerning the handling of infectious material of the respective laboratory, safety clothing (e.g. particle mask, gloves, protective shoe covers) must be worn. Infectious waste must be disposed of according to the respective regulations. To avoid the hazard of malfunction of an instrument, it must only be operated in a controlled electromagnetic environment. This means that transmitters such as mobile phones must not be operated in their close vicinity. In case of malfunctions and/or service work, please turn off the instrument and contact your local dealer Page 8

9 Safety Devices Section 2 Specifications Technical Specifications Dispensing Console Size in mm Width 595, Depth 650, Height 430, Size in Inches Width 23.4, Depth 25.6, Height 16.9 Electrical Voltage V/50-60 Hz V/50-60 Hz connections Power consumption 7.5A 3.6A Adjustable temperature range Capacity Weight Primary circuits Sound pressure Paraffin storage tank Right and left chambers from 50 to 70 C Work AREA Forceps from 50 to 75 C Auxiliary heated forceps from 60 to 75 C Paraffin storage tank 5 l Right and left chambers 2.2 l 62.3 lbs. (27.8 kg) V, 2 x T10AH V, 2 x T5AH 45 db (A) - measured with 1 m distance to the instrument Cryo Console Size in mm Width 340, Depth 600, Height 405, Voltage 100 V/50 60 Hz 100-V/ V/ V/ Electrical Hz Hz 50-60Hz connections Power consumption 3 A 2.4A 3.0 A 1.2A Adjustable temperature Adjustable from 0 to -12 C Size of the cold plate 305 x 375 mm Weight kg Ambient Max. humidity 80% (without condensation) conditions Temperature range from 5 C to 40 C Primary circuits V, 2 x T10AH V, 2 x T6,3AH Sound pressure 45dB(A) measured with 1 m distance to the instrument Dispensing & Cryo Console Transport and Storage Requirements Storage temperature range: -20 C up to +50 C Operating conditions: +5 C to +40 C (at a max. rel. humidity of 60%) altitude up to 2000 m M.S.L. Pollution degree: 2 Overvoltage category: II Floor loading requirements: 150 kg/m 2 Page 9

10 Section 3 Preparation/Installation Unpacking Instrument Insert pictures and procedure for unpacking and installing instrument Connecting the TEC -II 1. Connect the power supply to the corresponding input on both console units. 2. If required, the Dispensing Console should be connected to the Cryo Console using the connection cable provided as shown below. 3. The pedal cable should also be connected to the Dispensing Console if the pedal has been supplied as an optional accessory, together with the additional external set of tweezers. 4. Tighten the screws on the plugs to prevent the connections from becoming loose. 5. To reach the maximum working efficiency, dispensing console must be always connected to the mains and with the mains switch in the ON position. Cryo Console Connection Cable Power Cable Power Cable Pedal Cable NOTE: The Dispensing Console and Cryo Console are independently connected to the power supply. However, if connected together, both units are controlled and programmed from the Dispensing Console. For this reason it is important that the cable connecting both units be correctly installed. After connecting both units to the power supply, make sure the connection cable is installed correctly, first turn on the Cryo Console and then the Dispensing Console. The POWER pilot light on the keyboard and beside the display screen indicates that the unit is energized. Under normal operating conditions the screen may display different messages depending on the status of the unit and the selected interface language: Page 10

11 Section 4 Operation Start Up and Programming Waiting for start-up. This display appears on the screen if the unit is programmed to start and stop within a time range which does not include the time now, or if the timer is set to 00:00. MANUAL MODE ON/OFF In this case, the console must be started manually by pressing the MANUAL MODE ON/OFF key (see page 15, Programming Start and Stop). Programmed pause. This display appears on the screen if the unit is programmed to remain on standby between certain dates, including the current date (see page 16, Programming Standby). Heating mode. The paraffin storage tank or another point that requires heating has not yet reached the programmed temperature. Press ESC key. ESC The display appears illuminated. The equipment is in operation with the settings as programmed. Pressing either the UP or DOWN keys successively display the temperatures of the following: 1. Paraffin: Reservoir 2. Cryo Console (If Activated) 3. Auxiliary Heated Forceps 4. Pipe: Paraffin Transfer Tube 5. Right Chamber 6. Left Chamber 7. Valve: Paraffin Dispenser 8. Area: Work Area 9. Forceps: Forceps Warming Area Keypad This soft-touch keypad is used to control and program the embedding center. Page 11

12 SET STBY SET TIMER Enables programming date intervals when the unit does not need to start automatically (e.g. public holidays, vacations, etc.). When the key is in programming mode, the pilot incorporated in the key will be lit. Sets the time when the unit will be turned on and off. When the key is in programming mode, the pilot incorporated in the key will be lit. SET TEMP Sets the temperature for the areas to be heated. SET CLOCK For setting local time and date. MANUAL MODE ON/OFF For manual control over starting and stopping the unit. When the unit is in manual mode, the pilot incorporated in the key will be lit. LIGHT Turns the dispensing nozzle light on/off. The pilot indicates that the light is on. HEAT COOL ALARM Starts and stops the heating process. Red pilot light: heating in progress. Green pilot light: at operating temperature. Starts and stops the Cryo Console. Green pilot light: the Cryo Console has reached the pre-set temperature. Red pilot light: the Cryo Console is stopped. Intermittent green pilot: the Cryo Console is in the start-up phase. Intermittent red pilot: the Cryo Console is disconnected from the power supply or not connected to the Dispensing Console. This key is used to acknowledge alarms and displays the most recent alarm conditions that have occurred. The red pilot indicates that an alarm has been activated. UP DOWN ESC When the unit is in operation (display lit), these keys successively display the current temperatures of each area. When the unit is in programming mode, these keys are used to set (increase or decrease) the values for the temperatures, times, dates, etc. Press this key to cancel any programming situation. ENTER This key is used to accept the option selected using the arrow keys. Once the <ENTER> key is pressed, the option is saved and program automatically advances to the next option. Page 12

13 Selecting Operating Parameters Before beginning to program the unit you will probably want to select the interface language including, the units for temperatures and other variables. 1. Turn off the Dispensing Console using the switch on the rear panel and then turn it on again. 2. Before 5 seconds have elapsed, press the following keys sequentially; MANUAL MODE, UP and DOWN. The screen will display the following message: S.A.T MANUFACTURER SELECT LANGUAGE *ENGLISH TEMPER. SELECTION *CELSIUS AUX. FORCEPS *ENABLED DATE FORMAT *EUROPEAN FORMAT This message indicates that the unit is in the special programming mode for Technical Service. After about 5 seconds the following message will appear: Use the UP or DOWN arrow keys to select the desired interface language. Once selected, press the <ENTER> key to confirm. The following screen is displayed: Use the UP or DOWN keys to select the temperature units as CELSIUS or FAHRENHEIT and confirm the choice by pressing <ENTER>. Use the UP and DOWN arrow keys to select ENABLED if the optional auxiliary tweezers are installed or DISABLED if they are not. Confirm by pressing <ENTER>. Use the UP and DOWN keys to select the date format: - European Format: DD-MM (Day - Month) - American Format: MM-DD (Month - Day) Confirm by pressing <ENTER>. Programming The TEC -II combines several easy programming options. It is possible to program: The real date and time (internal clock/calendar) The temperature of each zone The scheduled time for automatic start-up 1 and shut down of the unit. That the unit does not start on certain dates (e.g. vacations, etc.) SET CLOCK Date and Time Should the display be greyed out press and hold the <MANUAL MODE> key for five seconds. 1 When programming the start-up time the unit automatically calculates when it should connect the heaters so that the temperatures of the paraffin and other areas are correct for the TEC -II to be used at that time. Page 13

14 Press the SET CLOCK key and the following display will appear (see page 14). Tuesday 11:40: The day of the week (in this example, Tuesday) flashes. UP DOWN ENTER 1. Change the day by pressing the UP or DOWN key and confirm the selection by pressing <ENTER>. 2. The first digit of the date then begins flashing. Remember that the date format may be DAY-MONTH-YEAR if the European date format has been programmed, or MONTH-DAY-YEAR, if the American date format has been programmed. 3. Change the date by using the UP or DOWN key as required and confirm the selection by pressing <ENTER>. 4. Repeat to edit all the values for the date and time. Temperatures SET TEMP Press the SET TEMP key and the following display will appear. SET TEMPERATURE PARIFFIN 60A Note that the temperature units (Celsius / Fahrenheit), will depend on those set in the section on language and units. Use the UP or DOWN keys to change the value, and confirm by pressing <ENTER>. Repeat the procedure for adjusting the temperatures for each zone of the TEC -II in the order shown below. Please note that for safety reasons some values are internally limited by the unit. This is why it is not possible to select temperature values that exceed certain limits. The recommended values for each of the zones (factory default values) are: Zone Temperature PARAFFIN 61 C f CRYO CONSOLE -10 C - 14 F AUX. HEATED FORCEPS 62 C F PIPE 62 C F RIGHT CHAMBER 62 C F LEFT CHAMBER 62 C F VALVE 62 C F AREA 60 C F FORCEPS 65 C F Page 14

15 NOTE: If the Cryo Console works as a stand-alone unit, temperatures will be adjusted through a potentiometer located at the back of the instrument. The list below shows temperatures of the Cryo Console depending on position of potentiometer knob: Knob Position Temp in C (±1 C) 0 0 C (OFF) 1 0 C C C C C C C C C C Automatic Start-up/Shutdown The Modular Embedding Center offers different program options for the unit operating times.: The same times from MONDAY to FRIDAY Different operating times (or stopped) on SATURDAYS and SUNDAYS Individual programs for each day of the week MANUAL MODE ON/OFF Should the display be grayed out press and hold the <MANUAL MODE> for five seconds. SET TEMP Press the SET TIMER key and the following display will appear. START UP *MON START UP *DAILY Use the UP or DOWN keys to select the operating time programmed for all work days (Monday to Friday) or if necessary, it is possible to individually program each day of the week. Confirm the selection by pressing <ENTER> The upper left corner of the display shows the appropriate reference (Monday to Friday or each day of the week) MON FRI ON TIME HH MM Use the UP or DOWN keys to change the value for start-up or operation of the unit if necessary, and confirm the selection by pressing <ENTER> to move to the next value Page 15

16 MON FRI OFF TIME HH MM SATURDAY ON TIME Default values for the TIMER (factory-set values) are: Once the start time has been set the screen will display the options for the unit shut-down time: Proceed in the same way to set time when the unit should be automatically shut-down. Once these values have been set, the option for SATURDAY and SUNDAY will display. If the unit is not to be used over the weekend enter the values 00:00 for START and 00:00 for STOP. Repeat the same operation for SUNDAY. If the DAILY option has been selected it will be necessary to set the START and STOP time for each day of the week. Day ON/OFF Time MON - FRI ON 08:00 OFF 15:00 SATURDAY ON 00:00 OFF 00:00 SUNDAY ON 00:00 OFF 00:00 Programming Pauses The TEC -II can be programmed so that it will NOT AUTOMATICALLY START between certain dates. This option is ideal for saving energy when the unit is not in use (e.g. Holidays or during vacations). Should the display be greyed out, press and hold the <MANUAL MODE> key for five seconds. SET STBY Press the <SET STBY> key and the following display will appear. SET STANDBY ON TIME DD MM Use the UP, DOWN and ENTER keys to set the day and month (or the month and day if the American format has been selected) ON WHICH the unit is NOT TO START automatically i.e., the beginning of the pause. Confirm the settings by pressing <ENTER> for each value. Page 16 Use the UP, DOWN and ENTER keys to set the END of the pause, i.e., the day and month the unit WILL COME INTO OPERATION AGAIN under normal programmed operating times. If the unit is not to have any programmed pause, enter as the values for START and STOP. The default values for the pause are: Pause Time START END 00-00

17 Section 5 Cleaning & Maintenance Daily Cleaning As it is a precision medical instrument, the Tissue Embedding Center TEC -II requires careful cleaning each day after use. Do not use solvents, harsh detergents, sharp or pointed objects to clean the unit. Always use citric based detergents or hot soapy water. The work AREA has drainage channels that guide any paraffin that has dripped into waste collection trays. Cleaning any paraffin that may be deposited in the waste trays is much easier if you cover the bottom of each tray with a piece of paper. CAUTION: Before the removing paraffin trays located right and left of the dispensing nozzle, be careful not to spill any paraffin. It may leak into the interior of the instrument where it may cause damage to some components. Maintenance Annual Maintenance - To maintain optimal performance, it is recommended Periodic Maintenance be performed by a trained service technician once a year. Fuse Replacement The instrument fuses are placed on the rear side of the instrument. To replace the fuses, deenergize the instrument and disconnect the POWER CABLE from the outlet. Unlock the FUSE CAP on the upper side by using a pointed tool (1) and fold down the FUSE LID (2). 3 2 Page 17

18 Pull out the red FUSE HOLDER and check or replace the FUSES. If replacing FUSES, please verify the fuse voltage (3) corresponds to the FUSE HOLDER. When inserting the FUSES into the FUSE HOLDER, please note the correct positioning of the lateral holding clips. Install the FUSE HOLDER so the voltage can be read and is upright. Reconnect the POWER CABLE and energize the instrument. Troubleshooting PROBLEM DESCRIPTION REMEDY Check: Instrument does not Power Paraffin not dispensed The POWER pilot light does not illuminate Paraffin is not dispensed when touchplate and/or foot switch is operated Electrical connections to the power supply. Position of the switch on the rear panel Condition of the two fuses located above the switch Check: The temperatures of the paraffin, delivery tube and valve have been set to adequate values. The nozzle flow rate is adjusted correctly. Alternatively operate the pedal and/or the touch-plate to see which of the two systems is failing. Insufficient heat Some of the zones do not heat Check that the temperatures are programmed correctly The cold area does not cool Cold Areas not cooling sufficiently to keep paraffin cold. Contact the Maintenance Service Center Alarm Messages ERROR SECURITY Indicates that the system has stopped automatically because of excess temperature. ERROR SENSOR ERROR Indicates that one of the temperature probes controlling the heating process is faulty. Page 18

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20 More Information PH: General Data Healthcare helps labs enhance productivity and improve workflow with innovative products, solutions and support that focus on delivering better patient safety & care General Data Healthcare, Inc. All rights reserved. Specifications are current at the time of publication; however, they are subject to change without notification. All trademarks and registered trademarks are property of General Data Healthcare, Inc., Cincinnati, Ohio, USA. Sales Inquiries: PH: Web: General Data Healthcare, Inc. Headquarters: 4354 Ferguson Drive, Cincinnati, OH TBS Facility: 3014 Croasdaile Drive, Durham, NC Service: PH: