Medite USE 33 Operation Manual [en, de]

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Ultrasonic Decalcifying Unit
Installation & Operation Manual
IMPORTANT: Read this manual carefully before starting the instrument!
Rev. 05 (05/2007)
© Copyright: Duplication of this manual by any means for any purpose without
written consent of medite GmbH is prohibited.
Wollenweberstr. 12 - D-31303 Burgdorf - Tel: +49 5136 888 4 0 Fax: + 49 5136 888 4 55 [email protected] www.medite.de
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Type of instrument:
Ultrasonic Decalcifying Unit
Model:
USE 33
Serial No.:
Konformitätserklärung
Certificate of Conformity
Attestation de Conformité
We do hereby certify that the above mentioned product meets the requirements set forth in the CE Guidelines indicated below including all changes and addendums to date thereto. The above mentioned product has been controlled by an authorized test center and meets the following standards and guidelines:
EU Directive 98/37/EEC Machinery EU Directive 89/336/EEC EMC EU Directive 73/23/EEC Low Voltage DIN EN ISO 9001 VDE 701
Burgdorf, 20.05.2007 M. Ott - Geschäftsführer
Wollenweberstr. 12 - D-31303 Burgdorf - Tel: +49 5136 888 4 0 Fax: + 49 5136 888 4 55 [email protected] www.medite.de
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Contents
1.
General description
1
1.1 Safety instructions
1
1.2 Power supply
1
1.3 Ground wire connection
1
1.4 Maintenance and repair
1
1.5 Cleaning of the water circulation system
1
1.6 Packing
2
2.
Installation
2
3.
Set up
2
4.
Instrument structure 3 5.
Operation
4
5.1 Cooling / Timer
4
5.2 Ultrasonic operation / Programmable timer 7 6.
Trouble shooting
10
6.1 Changing the fuse
11
7.
Technical specifications
11
8.
Accessory ( for separate order )
12 9
Application collection Use 33 2003-2004
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1. General description
The following instructions for safety must be strictly observed to guarantee a safe operation of the instrument. The same precautions considered when using any technical equipment have to be observed. Failure to follow the recommended procedure as outlined in this manual or misuse of the instrument will void the manufacturer’s warranty.
1.1 Safety instructions
do not use the instrument without water do not use inflammable liquids and chemicals containing or separating chloride
with the ultrasonic device
 use aggressive chemicals only in the inset vessels  do not put anything on the bath ground  do not touch the liquid while ultrasound is in operation  keep the instrument’s surface and controls clean and dry  do not use for living beings  empty instruments before transporting them  during the ultrasonic operation cavitation noise is produced. In case of
continued presence in an area of 2 m around the instrument ear protections shoud be worn to prevent from health damage.
1.2 Power supply
Before switching on the instrument check the compatibility of voltage and frequency with the indications on the instrument label at the back of the unit. Operating the instrument with a wrong voltage may cause damage!
1.3 Ground wire connection
As a prevention from electrical shock the instrument must be grounded. The unit is supplied with a power plug with ground wire connection.
1.4 Maintenance and repair
Never remove parts of the casing during operation! The replacement of parts and other interventions in the instrument may be done by
authorized service staff, only.
1.5 Cleaning of the water circulation system.
In order to avoid a clogging of the circulation system please follow this instruction once every four weeks:
Take out the holder and let water drain off the bath. Remove coarse debris by a cloth. Fill the bath and the tubing system with approximately 5 litres of cleaning agent
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( DECON 90 about 5-10%, dissolved in water), switch on the pump and rinse the tubing system with this solution and leave it in over night.
1.6 Packing
The packing of the ultrasonic decalcifying unit USE 33 contains:
USE 33 power cord lid to cover the holders user’s manual USE 33
2. Installation
After unpacking the instrument protecting films possibly existing on polished metal surfaces must be removed. Inspect the instrument with regard to transport damages. If transport damages are detected, do not connect the instrument to the power supply. The bath should be cleaned thoroughly before starting operation.
The USE 33 is equipped with cooling slots on both sides. In order to provide sufficient heat removal the instrument should be positioned in such a way that there is a minimum distance of 30 cm from the wall. Furthermore, the unit must be level on a dry and solid base.
3. Set up
1. Examine whether the drain tap is closed
2. Fill in tap water
3. Filling height: The water outlet must be completely covered with water.
4. When holders are equipped with vessels the water level should reach the lower edge of the holder.
5. Vessels must not touch the bath ground!
6. Plug the power cord in the socket at the back of the instrument and connect to the power supply (wall socket). Make sure that the drain tap is closed.
Operating conditions:
- the instrument must be used in closed rooms, only
- ambient temperature + 15°C to + 40°C(without considerable fluctuations)
- maximum height 2000 m ( according to EN 61010-1:2001)
- vibration free laboratory table adequate to the weight of the unit
- maximum relative humidity of 80%, not condensing for temperatures up to 31°C, linear decreasing to 50% relative humidity at 40°C
- do not expose the unit to direct sunlight
- variation of supply voltage not higher than +/-10% of the nominal voltage
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4. Instrument structure
Fig. 1: Front view USE 33
Fig. 2: Rear view USE 33
Power connection with fuse holder
Timer Ultrasound
Temperature control cooling
Bath
Fig. 3: right side USE 33
Air outlet
Water outlet
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Fig. 4: internal view USE 33
Water outlet. Minimum water level: must be above the water outlet
5. Operation
The instrument can be switched to standby mode using the switch on the rear of the instrument.
5.1 Controller Cooling / Timer
After switching on the instrument the actual temperature of the liquid is indicated in °C on the display. Individual temperatures for the contents of the bath can be adjusted by the temperature control.
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Features
Key 1: Up
This key is used to increase the temperature or time value, respectively.
Key 2: Down
This key is used to decrease the temperature or time value, respectively.
Key 3: SET
By pressing this key the mode is changed from SET temperature to SET timer and standard mode.
Key 4: START/STOP
This key is used to start an endless operation or stop the timer operation if the instrument is in timer mode.
KEY 5: TIMER START
This key is used to start or stop the timer
Key 4: Stand-by
This key is used to switch the instrument on and off, respectively (standby mode)
Indication of temperatures above 45°C
No function in the operation of the USE 33
Indication: Cooling active
Indication: Fan and Ultrasound active
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Switch to temperature setting (press 1x )
or
Adjust the desired value
Switch to timer setting (press 2x)
or
Adjust the desired value
Set the temperature
The temperature value for the Ultrasonic Decalcifying Unit USE 33 is modified by pressing the key SET once and then press the keys Up or Down.
If one of the keys Timer, Start/Stop or Standby is pressed, the indication on the display immediately switches to normal mode. The newly set value becomes active by releasing the keys. This does not interfere with a possibly activated running timer.
Set the duration time
The duration time for the Ultrasonic Decalcifying Unit USE 33 is set by pressing the key SET twice and then pressing the keys Up or Down. The value is adjustable from 0 up to 99 hours 59 minutes.
If the timer value is changed while the timer is running, the changed value will become effective only after the timer had been stopped or the time interval has passed.
If one of the keys Timer, Start/Stop or Standby is pressed, the indication on the display immediately switches to normal mode. The newly set value becomes active by releasing the keys.
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Key 1: UP
This key is used to increase the set time interval which is indicated when the key SET TIME is pressed. During programming this key is used to go to the next position.
Key 2: DOWN
This key is used to decrease the set time interval which is indicated when the key SET TIME is pressed. During programming this key is used to go to the previous position.
Key 3: SET TIME This key is used to indicate a set time interval. In combination with the UP or DOWN key the interval is changed accordingly. In the basic mode the actual daytime can be corrected like this. In the programming mode this key combination is used to change the start and stop time. Furthermore, if also the key PROG is pressed while programming, the settings of the previous day can be copied to the actual day.
Key 4: PROG
If this key is pressed and held for 5 seconds, you enter the programming mode for the start and stop times. The programming always starts with „Monday – start time – line 1.” If also the key SET TIME is pressed, the settings of the previous day can be copied to the actual day.
5.2 Ultrasonic operation / Programmable timer
Features
The timer is used to preset the duration time and to switch on or off the ultrasound, respectively.
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Key 5: ALL ON
This key is used to stop all control cycles. The timer settings are ignored and the ultrasonic module is switched on. This mode is shown in the display by the indication "ALL". Pressing this key again, the mode returns to the programmed settings, whereas those lines which are actually on remain on. By switching the mains switch off and on, the instrument returns to the programmed mode.
Key 6: STAND-BY
This key is used to switch the instrument to standby mode. If it is pressed again, the active mode is restored. In the standby mode all lines are switched off. The indication shows "OFF" and the LEDs are off. By switching the mains switch off and on, the instrument returns to the programmed mode.
Adjust actual day and time
If the SET TIME key is pressed while the instrument is in basic mode, the day time can be changed by additionally pressing the key UP or DOWN, respectively. To change the weekday go beyond midnight (24:00 hours). When all keys are released the new adjustments for day and time will be stored.
+ or
Adjustment of the start and stop times
Having entered the programming cycle by pressing the key PROG for 5 seconds the different positions are activated in the following sequence by pressing the UP or DOWN key
Indication LED
ON1 Monday OFF1 ON2 OFF2 ON3 OFF3
ON1 Tuesday OFF1 ON2 OFF2 ON3 OFF3
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ON1 Wednesday OFF1 ON2 OFF2 ON3 OFF3
ON1 Thursday OFF1 ON2 OFF2 ON3 OFF3
ON1 Friday OFF1 ON2 OFF2 ON3 OFF3
ON1 Saturday OFF1 ON2 OFF2 ON3 OFF3
ON1 Sunday OFF1 ON2 OFF2 ON3 OFF3
ON1 Monday OFF1...
After having reached the desired program position, by pressing the key SET TIME the set time is indicated and can be changed by using the key UP or DOWN. When all keys are released, the new value is stored.
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Display
Reason
Action
rC
Loss of data in timer
Adjustment of timer
EP
Loss of data in memory
Repair of controller
ALL
Modus "On", all outputs active
-----
Adjustment advice
The programming is made similar to that of an analogue timer, where one tag per day can be set each for start and stop time , but it is not a must. The endless loop in the programming cycle enables a quick access to the weekend days Saturday and Sunday by pressing the DOWN key.
Please note that there is no action if the start and stop time for the same day are identical.
Between the times 23:59 and 0:00 there is the special position "----". This adjustment deactivates the time setting. It is used to leave the instrument on during the day change or to keep it in on or off mode during several days.
If during programming the PROG key is pressed while the SET TIME key is held after a day has been chosen, all times set for the previous day are copied to the
chosen day and the display shows "COPY".
Return to basic mode
When the PROG key is pressed for at least 3 seconds or all other keys are released for more than 60 seconds, the instrument returns to basic mode.
Error codes and displays
6. Trouble shooting
At the rear of the instrument there is the power socket with integrated fuse holder. In case of a non-functioning of a unit, replace the fuse. The correct fuse parameters are shown on the instrument label.
In case of any other defect, please contact the
service department. Please do not try to repair the instrument
yourself. Unauthorized modification or repair by third party persons will void warranty.
6.1 Changing the fuse
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Width
:
450 mm
Depth
:
600 mm
Hight
:
350 mm
Filling capacity
:
13,5 litres
Cooling temperature
:
14°C to 25°C 1°C Weight
:
30 kg
Power supply
:
230 V / 50 Hz or 115 V / 60 Hz 400 VA
Fuse
:
4 A
First pull out the mains plug !
Using a screw driver it is easy to open the fuse socket and to change the fuse.
Fuse socket
7. Technical specifications
Ultrasonic decalcifying unit USE 33
8. Accessory ( for separate order )
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Description:
Cat. No.:
Holder for glass jars for USE 33 Holder for specimen, no. 1 Qty. of specimen: 4 Specimen container size: d = 93 mm Height: 110 mm Container volume: approx. 800 ml. Max. size of specimen : 250 cm3
28-8252-00
Holder for glass jars for USE 33 Holder for specimen, no. 2 Qty. of specimen 9 Specimen container size: d = 51 mm Height: 85 mm Container volume: approx. 150 ml Max. size of specimen: 30 cm3
28-8253-00
Holder for plastic pots for USE 33 Holder for specimen, no. 3 Qty. of specimen: 49 Specimen container size: d = 25 mm Height: 40 mm Container volume: approx. 20 ml Max. size of specimen: 5 cm3
28-8254-00
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Application/
Tissue
Sample Weight/Size
Type of decalcifying reagent Condition:
Tested staining and IHC reagents
Comment & Error
bone marrow biopsies
Weight: approx.. 0,5 - 0,8 g Length: 8 - 17 mm : 0,2 - 0,6 mm
Single (isolated independently treated samples), (plastic vial), Insert No.3 Reagent: 20 ml USEDECALC® Reaction time in USE 33: 8 - 17 h Additional treatment: Optional running water or washing 5-10 min with fresh water in the USE 33
HE, Giemsa, CD 61, ASDCL (Chloracetat-Esterase); Gomori Silverimpregnation AG NOR, Berlin blue (FE), Hematoxilin Eosin (Hemalaun) IHC and Protease s. Ref. 1 & 5
Fine morphological and immunhistological results. The data are based on 50 to 80 investigations within 2002 to 2003
Possible or known error: none
cartilage tissue
Weight up to 1,5 g Length: 10 - 30 mm : 10 mm
Single (isolated independently treated samples), (plastic vial), Insert No.3 Reagent: 20 ml USEDECALC® Reaction time in USE 33: 24 h Additional treatment*): Optional running water or washing 5-10 min with fresh water in the USE 33
HE, Giemsa, CD 61, ASDCL (Chloracetat-esterase); Gomori Silberimpregnation, Berlin blue (FE), Hematoxilin Eosin (Hemalaun)
Fine morphological and immunhistological results.
Possible or known error: none
cartilage tissue
Weight up to 2,5 g Length: ca. 20 - 35 mm Width: 5 bis 10 mm Heigth: 5 bis 10 mm
Insert No. 1 (46-1026-00, beaker made of glass) with approx. 40 ml USERAPID® Reaction time: 3 - 18 h Additional treatment: neutralize within approx. 1 h using USEDECALC® optional (followed by running water or washing 5-10 min with fresh water in the USE 33)
HE, Giemsa, CD 61, ASDCL Gomori Silberimpregnation, Berliner Blau, Hematoxilin Eosin (Hemalaun)
Fine morphological and immunhistological results.
Possible or known error: ASDCL: a weak stain might occur in dependence of the length of the reaction time.
Full slice of Ilium head
Weight: not documented : 20 - 35 mm thickness: 2 - 5 mm
Insert No. 1 (46-1026-00, beaker made of glass) with approx. 40 ml USERAPID® Reaction time: 24h
Additional treatment: neutralize within approx. 1 h using USEDECALC® optional (followed by running water or washing 5-10 min with fresh water in the USE 33)
HE, Giemsa, CD 61, ASDCL Gomori Silberimpregnation, Berlin blue (FE), Hematoxilin Eosin (Hemalaun)
Good and reproducible morphological and immunhistological results. Possible or known error: ASDCL: a weak stain might occur in dependence of the length of the reaction time. In case the sample is not satisfactorily decalcified „Rapid Block Post
Decalcification Procedure“:
where appropriate, trim sample (Paraffin block) and shortly decalcify the block within 5 -10 minutes in the USE beaker with USERAPID® followed by a 2-3 minute neutralization in USEDECALC® ..
USE Application USE 33 2003-2004
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Collection of USE 33 procedures. These procedures are compiled results of our users. Recommended common temperature range for decalcification of all samples is 16°C to 17°C. This temperature range can be adjusted in the USE 33.
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Application/
Tissue
Sample Weight/Size
Type of decalcifying reagent Condition:
Tested staining and IHC reagents
Comment & Error
Incisor (human)
Weight: 1,2 – 2 g
Insert No. 1 (46-1026-00, beaker made of glass) with approx. 40 ml USERAPID® Reaction time: 24-48h
Additional treatment: neutralize within approx. 5 – 30 min using USEDECALC® optional (followed by running water or washing 5-10 min with fresh water in the USE 33)
HE, Giemsa, CD 61 Gomori Silverimpregnation, Berlin Blue, Hematoxilin Eosin (Hemalaun) See Ref. 3
„Rapid Block Post Decalcification
Procedure“:
where appropriate trim sample (Paraffin block) and decalcify the block within 20 -30 minutes in the USE beaker with USERAPID® followed by a 2-3 minute neutralization in USEDECALC® .
bone marrow biopsies
Weight ? Length 8 bis 12 mm : ca. 0,2 mm
Insert No. 1 (46-1026-00, beaker made of glass) with approx. 40 ml USERAPID® Reaction time: 1 h
Additional treatment: neutralize within approx. 3 h using USEDECALC® optional (followed by running water or washing 5-10 min with fresh water in the USE 33)
HE, Giemsa, ASDCL, CD3, CD79a, CD 34, MPO IHC Reagents from DAKO CYTOMATION See Ref. 2
Approx.. 50 samples had been investigated
The short reaction time of USERAPID® showed good and reproducible results for IHC and ASCDL (Chloracetic-esterase) .
Incisor (human)
Weight: ca. 1,2 - 2 g
Insert No. 1 (46-1026-00, beaker made of glass) with approx. 40 ml USERAPID® Reaction time: 3 d Additional treatment: neutralize within approx. 5-30 min using USEDECALC® optional (followed by running water or washing 5-10 min with fresh water in the USE 33)
Alcian Bue, Immunhistochemie IGF II s. Ref. 3
Decalcification procedure allows an ideal morophological and immunhistochemical follow up
Incisor (human)
Weight: ca. 1,2 - 2 g
Insert No. 1 (46-1026-00, beaker made of glass) with approx. 40 ml USERAPID® Reaction time: 11 d Additional treatment: neutralize within approx. 3d min using USEDECALC® optional (followed by running water or washing 5-10 min with fresh water in the USE 33)
PAS
Hard material, in laboratory routine these samples need a decalcification time of several weeks with RDO®. With other methods these samples are not accessable.
Lower jaw/ mandible (Rat)
Weight: ? Length:
Insert No. 2 (46-1027-00, beaker made of glass) with approx. 40 ml USERAPID® Reaction time: 7 d Additional treatment: neutralize within approx. 3 d min using USEDECALC® optional (followed by running water or washing 5-10 min with fresh water in the USE 33) where appropriate „Rapid Block Post Decalcification Procedure“
HE, Giemsa, Immunhistochemie ED1 Osteoklasten, Osteoid HE, Alcianblau s. Ref. 3
Time is not optimised. A faster procedure is in validation. Dendrite,mucosa, Osteocyte, Predontoblaste Osteoclaste, dendriteskin, longitudinal and cross sections through teeth, Desmodont bone
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Application/
Tissue
Sample Weight/Size
Type of decalcifying reagent Condition:
Tested staining and IHC reagents
Comment & Error
Block from ileum cortical >90%
Weight ca. 0,5 g
Insert No. 1 (46-1026-00, beaker made of glass) with approx. 40 ml USERAPID® Reaction time: 2-3 d Additional treatment: neutralize within approx. 3 h using USEDECALC® optional (followed by running water or washing 5-10 min with fresh water in the USE 33) where appropriate „Rapid Block Post Decalcification Procedure“
HE, Giemsa, KL1, MIB1, Vimentin, S100
Results from systematic optimization trials Often the samples had not been
„cuttable“ after 14 days decalcification
with EDTA, only. Missing: The proof of RNA
conservation was not investigated systematically.
Block frum ileum cortical approx. >50%
Weight ca. 0,5 g
Insert No. 1 (46-1026-00, beaker made of glass) with approx. 40 ml USERAPID® Reaction time: 1 h Additional treatment: neutralize within approx. 4 -6 h using USEDECALC® optional (followed by running water or washing 5-10 min with fresh water in the USE 33) where appropriate „Rapid Block Post Decalcification Procedure“
HE, Giemsa, KL1, MIB1, Vimentin, S100 s. Referenz 4
Results from systematic optimization trials.
Often the samples had not been
„cuttable“ after 24 hours
decalcification with EDTA, only. DNA conservation is comparable
towards „standard lab EDTA“
processing.
bone marrow biopsies base material for „Histo-Chips“ or Multi Tissue Array
Weight: ca. 0,5 - 0,8 g Length: ca. 8 - 17 mm : ca. 0,2 - 0,6 mm
Insert No. 1 (46-1026-00, beaker made of glass) with approx. 40 ml USERAPID® Reaction time: 1-2 h Additional treatment: neutralize within approx. 2 -6 h using USEDECALC® optional (followed by running water or washing 5-10 min with fresh water in the USE 33) where appropriate „Rapid Block Post Decalcification Procedure“
RA, RAEB, Leder‘s Stain, CD34, Ki­67, bcl-2 s. Referenz 5
„Rapid Block Post Decalcification
Procedure“ is a possible and
recommended opportunity for „Histo Chips“
- for instance after EDTA operation in case the block cannot be cut on the microtome.
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„Rapid Block Post Decalcification Procedure“:where appropriate cut sample (Paraffin block) and decalcify the block within 5 -10 minutes in the USE beaker with USERAPID® followed by a 2-3 minute neutralization in USEDECALC® .
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A compilation of applications for higher volume samples like animal (dog, rat) skull including a validation for staining and IHC-procedures is in preparation.
References & Results of tests:
1)
Techniken und Methoden der Histo- und Immunfärbung an entkalkten Gewebeproben, Applikationen für den medite USE 33 Ultraschall-Schnell-Entkalker mit gewebeschonender USEDECALC Entkalkerlösung, Herr Prof. Hansmann, Herr Lieberz, Universität Frankfurt, medite Broschüre 2003
2)
Beurteilbarkeit von Knochenpunktionszylindern nach unterschiedlicher Fixation und identischer Entkalkung im USE 33, Dr. Knolle, Frau Dr. Hege, Herr Balthasar, Klinikum Dessau.
3)
Prüfung der Eignung des USE 33 für den Einsatz an der Poliklinik für Kieferorthopädie Bonn, Prof. Götz, Frau Beil.
4)
Entkalkung mit dem Ultraschall für immunhistologische Nachweise, MHH, Dr. Länger, Frau Lehne.
5)
Analysis of differential protein expression in myelodysplastic
Syndromes using histo-chips, Engels .K, Kriener .S, Lieberz .R,
Hansmann .ML, Senckenberg‘s Institute of Pathology, University
Frankfurt/M., Germany Thanks to the kind permission and support to all who assisted. This application was issued by medite Medizintechnik GmbH
Wollenweberstr. 12 D-31303 Burgdorf
USE Application USE 33 2003-2004
16
Figure: Histo Chips from bone marrow biopsies. Thanks to the kind permission of Prof. Hansmann and Mr. Lieberz Universität Frankfurt 5)
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Cooling Unit TES 99.410
Width : 500 mm Depth : 570 mm Height : 300 mm Cooling plate : 500 x 260 mm Temperature : adjustable from +15° C to -15° C Weight : 25 kg Voltage : 230V / 50Hz / 320VA
TES 99.420
Width : 360 mm Depth : 570 mm Height : 300 mm Cooling plate : 360 x 260 mm Temperature : adjustable from +15° C to -10° C Weight : 20 kg Voltage : 230V / 50Hz / 150VA
TES 99.430
Width : 360 mm Depth : 570 mm Height : 300 mm Cooling plate : 210 x 260 mm Temperature : adjustable from +15° C to -10° C Weight : 20 kg Voltage : 230V / 50Hz / 150VA
Dispenser Unit TES 99.200
Width : 360 mm Depth : 570 mm Height : 300 mm Working plate : 360 x 245 mm Temperature : adjustable fom + 30° C to + 70°C Capacity of paraffin tank : 3,5 litres Cold point : -5° C 40 mm Ø Heating for 6 forceps Weight : 22 kg Voltage : 230V / 50Hz / 350VA
Thermal Unit TES 99.600
Width : 360 mm Depth : 570 mm Height : 300 mm Preheating : 305 x 205 mm Warming tray : 295 x 235 mm Weight : 15 kg Voltage : 230V / 50Hz / 750VA
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medite – Supplier of complete systems for histology-cytology-pathology e. g. paraffin embedding system TES 99
Wollenweberstr. 12 - D-31303 Burgdorf - Tel: +49 5136 888 4 0 Fax: + 49 5136 888 4 55 [email protected] www.medite.de
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