Leica EG1150 H User Manual

Instructions for Use
Leica EG1150 H
Paraffin Embedding Station
Leica EG1150 H V 2.5, English 09/2014 Order No.: 14 0388 81101 RevF
Always keep this manual with the instrument. Read carefully before working with the instrument.
IMPORTANT NOTE
The information, numerical data, notes and value judgments contained in this manual represent the current state of scientific knowledge and state-of-the-art technology as we understand it following thorough investigation in this field. We are under no obligation to update the pres­ent manual periodically and on an ongoing basis according to the latest technical developments, nor to provide our customers with additional cop­ies, updates etc. of this manual. To the extent permitted in accordance with the national legal system as applicable in each individual case, we shall not be held liable for erroneous statements, drawings, technical illus­trations etc. contained in this manual. In particu­lar, no liability whatsoever is accepted for any financial loss or consequential damage caused by or related to compliance with statements or other information in this manual. Statements, drawings, illustrations and other information regarding the contents or technical details of the present Instructions for Use are not to be considered warranted characteristics of our products.
These are determined only by the contract provisions agreed between ourselves and our customers. Leica reserves the right to change technical specifications as well as manufacturing process­es without prior notice. Only in this way is it pos­sible to continuously improve the technology and manufacturing techniques used in our products. This document is protected under copyright laws. All copyrights to this documentation are held by Leica Biosystems Nussloch GmbH. Any reproduction of text and illustrations (or of any parts thereof) by means of print, photocopy, microfiche, web cam or other methods – includ­ing any electronic systems and media – requires express prior permission in writing by Leica Biosystems Nussloch GmbH. For the instrument serial number and year of manufacture, please refer to the nameplate on the back of the instrument.
© Leica Biosystems Nussloch GmbH
Issued by: Leica Biosystems Nussloch GmbH
Heidelberger Str. 17 - 19 D-69226 Nussloch Germany Phone: +49 (0)6224 143-0 Fax: +49 (0)6224 143-268 Internet: http://www.LeicaBiosystems.com Assembly contracted to Leica Microsystems Ltd. Shanghai
Leica EG1150 H – Paraffin Embedding Station
Table of contents
1. Important Information ................................................................................................................................ 5
1.1 Symbols in the text and their meanings ................................................................................................... 5
1.2 Intended use of instrument ......................................................................................................................... 6
1.3 Qualification of personnel ........................................................................................................................... 6
1.4 Instrument type ............................................................................................................................................. 6
2. Safety ............................................................................................................................................................ 7
2.1 Safety notes .................................................................................................................................................. 7
2.2 Warnings ....................................................................................................................................................... 8
2.3 Integrated safety devices ........................................................................................................................... 9
3. Instrument Components and Specifications........................................................................................ 10
3.1 Technical data ............................................................................................................................................ 10
3.2 Overview — instrument components ..................................................................................................... 11
3.3 Instrument specifications ......................................................................................................................... 12
4. Instrument Setup ....................................................................................................................................... 13
4.1 Unpacking and installation ....................................................................................................................... 13
4.2 Location conditions .................................................................................................................................... 14
4.3 Delivery range ............................................................................................................................................. 15
4.4 Necessary assembly work ....................................................................................................................... 16
4.5 Optional accessories ................................................................................................................................. 18
4.6 Electrical connection ................................................................................................................................. 19
5. Operation .................................................................................................................................................... 20
5.1 Instrument parts/functions ....................................................................................................................... 20
5.2 Switching the instrument on .................................................................................................................... 25
5.3 Control panel functions ............................................................................................................................. 26
5.4 Operating modes ........................................................................................................................................ 27
5.5 Time-program control ................................................................................................................................ 28
5.6 Instrument heater ....................................................................................................................................... 30
6. Maintenance and Cleaning..................................................................................................................... 32
6.1 Cleaning the instrument ............................................................................................................................ 32
6.2 Maintenance instructions ......................................................................................................................... 33
7. Troubleshooting ........................................................................................................................................ 34
7.1 Possible faults ............................................................................................................................................. 34
7.2 Changing a fuse .......................................................................................................................................... 37
8. Warranty and Service .............................................................................................................................. 39
9. Decontamination Certificate (Master) .................................................................................................. 40
Instructions for Use V 2.5 RevF – 09/2014

1. Important Information

1.1 Symbols in the text and their meanings

Warnings appear in a gray box and are marked by a warning triangle .
Notes, i.e. important user information appear in a gray box and are marked by an
.
(5)
ENTER
information symbol
Solvents and reagents that are inflam­mable are marked with this symbol.
This warning symbol indicates the sur­faces on the instrument that are hot during operation. Avoid direct contact to prevent risk of burning.
Figures in brackets refer to item num­bers in figures.
Function keys that have to be pressed on the input screen, are displayed in bold type and capital letters.
Manufacturer
Observe the Instructions for Use
Date of manufacture
This product fulfills the requirements of the Council's Directive 98/79/EC concerning in vitro diagnostics (IVD) medical devices.
REF
SN
~
Environmental protection symbol of the China RoHS directive. The number in the symbol indicates the "Environment­friendly Use Period" of the product. The symbol is used if a substance restricted in China is used in excess of the maxi­mum permitted limit.
Symbol for labeling electrical and elec­tronic equipment in accordance with Sec­tion 7 of the German Electrical and Elec­tronic Equipment Act (ElektroG). ElektroG is the law regarding the sale, return and environmentally sound disposal of electri­cal and electronic equipment.
Order No.
Serial number
Symbol for alternating current
Tip-n-Tell indicator to monitor wheth­er the shipment has been transported and stored in upright position accord­ing to your requirements. With a pitch of 60° or more, the blue quartz sand flows into the arrow-shaped indicator window and sticks there permanent­ly. Improper handling of the shipment is immediately detectable and can be proven definitively.
In the Shockwatch system, a precision glass tube shows shocks or impacts that are above a specified intensity through red coloration. Exceeding a defined acceleration (g value) destroys the surface tension of the liquid in the interior of the tube. This causes the indicator tube to change color.
Leica EG1150 H – Paraffin Embedding Station
1. Important Information

1.2 Intended use of instrument

The Leica EG1150 H is a modern paraffin embedding station with microprocessor control system. It is designed for embedding histological tissue specimens in molten paraffin for use in pathol-
ogy laboratories and only for the following tasks:
• Melt solid paraffin for sample embedding and maintain the molten paraffin at the required temperature.
• Pour paraffin into embedding molds where the specimens are placed.
• Heat and maintain the temperatures of embedding cassettes with specimens and molds as
well as the required forceps.
Any other use of the instrument will be considered as improper use!

1.3 Qualification of personnel

• TheLeicaEG1150Hmaybeoperatedbytrainedlaboratorypersonnelonly.
• AlllaboratorypersonneldesignatedtooperatethisinstrumentmustreadtheseInstructions
for Use carefully and must be familiar with all technical features of the instrument before attempting to operate it.

1.4 Instrument type

All information provided in these Instruc­tions for Use applies only to the instrument type indicated on the cover page. A name plate with the serial number is at­tached to the back of the instrument.
Fig. 1 is provided as an example only and shows a valid nameplate for this instrument with the necessary in­formation about instrument type and power requirement. The precise data for the various versions is specified in
Chapter 3.1, "Technical data".
Fig. 1
Instructions for Use V 2.5 RevF – 09/2014
The safety and caution notes in this chapter must be observed at all times. Be sure to read these notes even if you are already familiar with the operation and use of other Leica products.

2.1 Safety notes

2. Safety

These Instructions for Use include important instructions and information related to the oper­ating safety and maintenance of the instrument.
The Instructions for Use are an important part of the product, and must be read carefully prior to startup and use and must always be kept near the instrument.
These Instructions for Use must be appropriately supplemented as required by the existing regulations on accident prevention and environmental safety in the operator's country.
The protective devices on the instrument and its accessories must not be removed or modified. Only service personnel qualified by Leica may repair the instrument and access the instru­ment's internal components.
Use only the provided power cable - this must not be replaced with a different power cable. If the power plug does not fit in your socket, contact our service.
Residual risks The instrument has been designed and constructed with the latest state-of-the-art technology and according to recognized standards and regulations with regard to safety technology. Oper­ating or handling the instrument incorrectly can place the user or other personnel at risk of in­jury or can cause damage to the instrument or other property. The instrument may be used only as intended and only if all of its safety features are in proper working condition. Malfunctions that impede safety must be remedied immediately.
This instrument has been built and tested in accordance with the safety requirements for electrical equipment for measurement, control, and laboratory use.
To maintain this condition and ensure safe operation, the user must observe all notes and warnings contained in these Instructions for Use.
For current information about applicable guidelines, please refer to the CE declaration of conformity and on our Internet site at:
http://www.LeicaBiosystems.com
Leica EG1150 H – Paraffin Embedding Station
2. Safety

2.2 Warnings

The safety devices installed in this instrument by the manufacturer only constitute the basis for accident prevention. Operating the instrument safely is, above all, the responsibility of the owner, as well as the designated personnel who operate, service or repair the instrument. To ensure trouble-free operation of the instrument, make sure to comply with the following instructions and warnings.
Warnings – Safety notes on the instrument itself
Safety notes on the instrument itself, which are marked with a warning triangle, indicate that the correct operating instructions (as defined in these Instructions for Use) must be followed when operating or replacing the item marked. Nonobservance can cause accidents, injuries and/or damage to the instrument/accessories.
Certain surfaces of the instrument are hot during operation under normal conditions. They are marked with this warning sign. Touching these surfaces can cause burns.
Safety instructions - transport and installation
• After unpacking the instrument it may only be transported in an upright position.
• Place the instrument on a laboratory table and adjust it to a horizontal position.
• The instrument must not be exposed to direct sunlight (window)!
• Plug the instrument only into a grounded power socket. The protective effect may not be
eliminated by an extension cable without a protective grounding conductor.
• The instrument automatically recognizes the applied voltage/frequency.
• The installation location must be well-ventilated; there should be no ignition sources there
of any kind.
• The instrument may not be operated in hazardous locations.
• Extreme temperature fluctuations between storage facility and setup site as well as high
humidity may cause condensation to form. In this case, wait at least two hours before switching on.
Instructions for Use V 2.5 RevF – 09/2014
Safety instructions - working with the instrument
Paraffin is flammable and should therefore be handled with due care. Do not use sharp tools to remove solidified paraffin from the work areas, as this may destroy the coating on the surface. Use the plastic spatula supplied with the instrument. During operation, the paraffin reservoir, embedding mold tray, cassette tray, work area as well as the forceps holder are hot. Risk of burning! Do not store any combustible and flammable substances near the instrument. There is a fire hazard if work with an exposed flame (e.g. Bunsen burner) is carried out in the direct vicinity of the instrument (solvent vapors). Therefore, keep all ignition sources at least 2 meters away from the instrument!
Hazards - servicing and cleaning
Switch off the instrument each time before servicing and pull out the power plug. When using cleaners, please comply with the safety instructions of the manufacturer and the laboratory safety regulations. Before changing defective fuses, the instrument has to be disconnected from the power supply. Only fuses that are easily accessible may be replaced by the user. Liquid must not get into the instrument while operating or cleaning it.
2. Safety

2.3 Integrated safety devices

The instrument is equipped with the following safety features and devices:
Fuses in the heating elements
All of the instrument's heating elements are equipped with overheating fuses, which trip if a heating element overheats and switch the element off.
Automatic circuit breaker in standby switch
An automatic circuit breaker is located in the standby switch. This circuit breaker separates the power electronics from the power supply in the event of a short-circuit. In this case, the standby switch jumps to the position "0" = Off.
Note that the only way the user has for complete disconnection from the power supply is disconnection of the power plug.
Leica EG1150 H – Paraffin Embedding Station

3. Instrument Components and Specifications

3.1 Technical data

General data
Approvals: The instrument-specific approval marks are located on
the rear panel of the instrument next to the type plate. Voltage of power supply: 100-120 V, 50/60 Hz 230-240 V, 50/60 Hz Power consumption: 1100 VA Protection class1: I Pollution degree1: 2 Overvoltage category: II Operating temperature range: +18 °C to + 40 °C Operating temperatures: 55 °C to 70 °C, adjustable in 5 Relative humidity: Max. 60 % non-condensing.
1)
according to IEC-1010, UL 3101, EN 61010
Fuses
Standby switch: Circuit breaker manufactured by ETA, model
3120-F421-P7T1-W01D-5A
Fine-wire fuses 6.3 x 32 mm: 2x T2.0 A; 2x T4.0 A; 4x T5.0 A; 2x T6.25 A Fuse type: Schurter: Type Fst
K increments.
Dimensions and weights
Dimensions: Height: 360 mm Width: 500 mm Depth: 640 mm Weight: Approx. 22 kg
Capacities
Paraffin reservoir: Approx. 3 l Cassette tray: Approx. 100 cassettes Embedding mold tray: Approx. 50 embedding molds
Programmable parameters
Temperature: Paraffin reservoir/dispenser (heating-up time = 4 h) Embedding mold tray, cassette tray, work top Time: Working day, current weekday Working times (start, end), current time
10
Instructions for Use V 2.5 RevF – 09/2014
3. Instrument Components and Specifications

3.2 Overview — instrument components

Standby switch
Forceps holder
Paraffin reservoir with lid
Control panel
Work area illumination
Dispenser
Lid
Cassette tray
Cassette tray
Work area
Lid Embedding mold tray
Embedding mold tray
Leica EG1150 H – Paraffin Embedding Station
Paraffin collection tray left
Cooling spot
Paraffin
collection tray
right
Fig. 2
11
3. Instrument Components and Specifications
Instrument rear view
Secondary fuses F1-F3
Heat sink
Port for power cord
Sliding elements
Secondary
fuses
F4-F5
Port for
foot switch
Fig. 3

3.3 Instrument specifications

• Paraffin reservoir with a capacity of 3 liters.
• The paraffin flow is activated by means of a height-adjustable, pivotable clip - activated either
manually by the mold or a foot switch (optional).
• Controllable flow rate.
• Removable, heatable (indirectly, via the work surface) paraffin collection trays.
• Spacious, easy-to-clean, heated work area, with integrated cooling spot, also for extra large cas-
settes ("Super Mega Cassettes") with paraffin drain system.
• Trays for cassettes and/or molds with sliding lid, removable and interchangeable.
• Removable, heated forceps holder for 6 forceps, accessible from both sides.
• Optimum illumination of the work surface by the individual adjustable LED lamp.
• Temperature range of cassette and embedding mold tray, work area and paraffin reservoir adjust-
able from 55 °C to 70 °C.
• Permanent temperature display for all the work areas.
• The beginning and end of the work time and work days can be programmed.
12
Instructions for Use V 2.5 RevF – 09/2014

4.1 Unpacking and installation

When the instrument is delivered, check the tilt indicators on the packaging. If the arrowhead is blue, the shipment was transported laying flat, was tilted at too great an angle or fell over during transport. Note this on the shipping documents and check the shipment for possible damage.
1
2

4. Instrument Setup

These unpacking instructions only apply if the box is placed with the
symbols facing upwards for unpacking.
1. Remove 8x screws (1) for the cover (2).
2. Remove the cover (2).
3. Lift up and remove the accessories (3) and inside cover (4).
4
3
Leica EG1150 H – Paraffin Embedding Station
3
Fig. 4
13
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