SOP FOR OPERATION AND MAINTENANCE OF PARAFFIN EMBEDDING STATION

1.0 Purpose: To lay down a uniform procedure for the operation and maintenance of a Paraffin embedding station for embedding histological tissue specimens in molten paraffin for use in surgical pathology

2.0 Scope: The scope of this Standard Operating Procedure covers the procedure for operation and maintenance of a Paraffin embedding station for embedding histological tissue specimens in molten paraffin for use in pathology at ResearchNeeds.

3.0 Responsibility: Technical staff

4.0 Reference/Associated documents: Leica -Instruction Manual

5.0 Abbreviations:

RT-Room Temperature

SOP- Standard operating procedure

6.0 Requirements:

Leica Paraffin Embedding Station

Paraffin

Specimen/tissue

Molds and Cassettes

7.0 Precautions:

a) Certain surfaces of the instrument are hot during operation and touching these surfaces can cause burns. Warning signs are displayed at these sites of the instrument.

b) Paraffin is flammable and should 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 spatula supplied with the instrument

c) Do not store any combustible and flammable substances near the instrument to avoid fire hazards.

d) Do not use recycled paraffin in the embedding station to avoid contamination.

8.0 Instructions:

A. Instructions:

8.1 Switch on the instrument. (Not required in case the instrument is set on programming mode)

8.2 The temperature and time are set for all the sections in case of programming mode else set the time and temperature for various sections.

8.3 Label the cassettes with the accession number of the tissue specimen received.

8.4 Adjust the height and position of the dispenser to align with the position of the mold.

8.5 The quantity of the paraffin released from the filler tube can be adjusted with the metering screw.

8.6 Slightly push the handle of the dispenser backward to open the valve to release the paraffin from the filler tube.

8.7 Fill the mold about one-third with liquid paraffin. To stop the flow of the paraffin, release the handle back into to original position. This will shut the valve.

8.8 Orient the tissue in the paraffin and place it on the refrigeration spot. The liquid paraffin begins to solidify rapidly on the refrigeration spot. Place the appropriately labeled cassette on the mold and fill the mold rapidly with paraffin.

Note: While orienting the tissue the paraffin should not become too solid as this may cause different phases in the finished block, including fissures inside as a result of which the block may break during sectioning.

8.9 Place the cassette on the refrigeration spot and then on the Refrigeration Unit (Leica EG 1150C).

Note: the refrigeration unit should be switched on at least half an hour before use so that it reaches the desired temperature (-5°C).

B. Instrument Parts and Functions:

8.10 Paraffin Reservoir: The paraffin reservoir has a capacity of 3 liters. The temperature is adjustable between 55°C to 70°C. When setting the temperature for the paraffin reservoir, observe the manufacturer's specifications for maximum permissible temperature. The built-in filtering screen prevents any particles contained in the paraffin from getting into the paraffin block. Activate the paraffin reservoir 4 hours before the work starts.

8.11 Dispenser: Dispenser is heated separately. The temperature adjustment of the dispenser and paraffin reservoir is coupled. The quantity of the paraffin released from the filler tube is adjusted continuously with the metering screw. The dispenser handle is used for manually operating the paraffin flow. The extension clip provided with the dispenser is height-adjustable and can be shifted to the sides depending on whether the dispenser handle is released with the mold or the finger. Slightly pushing the handle backward will open the dispenser valve. Once released the handle flips back to the original position and the valve shuts.

8.12 Work Area: The temperature of the work area can be adjusted between 55°C to 70°C. This includes the embedding area, forceps holder, and refrigeration spot. A groove around the work area and several drain holes are provided to allow liquid paraffin to drain rapidly.

The refrigeration spot, positioned in the front of the work area enables convenient working in ergonomically most favorable conditions. To orient the samples, the mold is filled about one-third with liquid paraffin. The liquid paraffin begins to solidify rapidly on the refrigeration spot. Finally, the mold can be rapidly filled with paraffin.

8.13 Mould and cassette warmer: Depending on the preferred working direction, the two heated trays can be used for molds or cassettes. The temperature of both can be adjusted between 55°C to 70°C. A removable receptacle placed in each of the trays can hold approx. 100 cassettes or 50 molds. The trays should be kept covered with the lids provided to maintain the desired temperature.

8.14 Setting the temperature values: The temperature for four heated areas can be adjusted in the range from 55°C to 70°C in 5 °C increments. Press the buttons for the temperature range once to increase the value by 5 OC. The red LED for the associated temperature value will light up after 70°C has been reached, and the temperature will revert to 55°C. Once set, the temperature value for one range will be retained until it is changed.

8.15 Control Panel: The control panel displays the LED for Individually Te heated areas which are: Cassette/ mold warmer Left, Paraffin reservoir, Work Area, and Cassette/ mold warmer right. The right side of the control panel consists of LEDs for the mode of indication of Working Day, Weekday, Start/end times, Real-time, and Current Working day. set buttons for programming activation of enhanced mode and Illumination status (ON/OFF)

8.16 Programming:

Setting Working Time:

Press the 'Timer' button (Clock symbol) until the green-colored "Start" LED is illuminated Set the desired start-of-work time in the display with the '+' or '' button. The time displayed is stored.

End-of-work time

Press the 'Timer' button (Clock symbol) until the green-colored "END" LED is illuminated.

Set the desired End-of-work time in the display with the '+' or 'button. The set time is stored. At the selected time, the instrument switches to program mode.

Setting Current Weekday:

Press the button with the 'calendar' display until the LED 'Today is illuminated. Select the current day with '+' or '' keys. The selected day will be marked green in the 'working day' display.

Setting the Working Days:

Note: The programmed functions of the instrument are operational only on the "working days"

Press the button with 'calendar display until the LED 'Working Day' is illuminated.

All working days are marked green, and the LED of the current day flashes.

Press the '+' or '' keys to mark the days to be defined or canceled as a working day. Press the 'ON/OFF' key once to add the marked day to, or remove it from the list of working days.

8.17 Program Mode: To set the instrument in program mode press the 'ON/OFF Te button for 2 seconds, such that all displays go out. On the next working day, the heaters will be switched on 4hours before the program-med start-of-work time.

The various sections are activated in advance as follows: Paraffin reservoir: Heating starts 4 hours before work starts

Work Area: Heating starts 4 hours before the work starts

Dispenser tube: Heating starts 1 hour before the work starts

Refrigeration spot: Heating starts Thour before the work starts

Note: The LED for the temperature selected will always light; the LED flashes as long as heating continues.

8.18 Other Working Modes: Enhanced Mode: The melting process of the paraffin can be sped up

by increasing the heat supply for four hours, in case solid paraffin is to be added to the reservoir while working in shifts or manual mode. To activate the enhanced mode press both the '+' and '' keys together and hold until all 4 LEDs of the paraffin tank light up simultaneously.

While Enhanced Mode is on the ED corresponding to the previously selected set value flashes. To deactivate the enhanced mode press both '+' and keys together and hold until all 4 LEDs light up simultaneously again.

Manual Mode: This mode is used while working on a day not defined as 'Working Day' or outside the programmed times. Switch the instrument from program mode to manual mode by pressing the ON/OFF key for 2 seconds. In this case, the four-hour standby heating is automatically activated.

8.19 Switch the instrument from manual mode to program mode by pressing the ON/OFF key for 2 seconds. The Instrument also automatically switches off after reaching the next programmed. 24-hour Mode: This mode is used while working in shifts. For the de-activation of the timer set the start and shut down time to the same time.

C. Cleaning

8.20 Cleaning the Instrument: Do not use xylene for cleaning. Xylene vapors are heavier than air and can ignite at a considerable distance from the source of heat. To avoid scratching the surface of the instrument only the plastic spatula that is supplied with it should be used for cleaning and not any metal tool.

8.21 Cleaning of the Work area: All common laboratory-cleaning products suitable for the removal of the paraffin (e.g. Paragaurad or Xylene substitutes) can be used to clean the work area. Avoid prolonged contact or organic solvents on the surface of the instrument.

8.22 Paraffin Reservoir: Keep contaminants out of the paraffin reservoir. Ensure that a residual amount of paraffin remains in the reservoir after draining to prevent solid contaminants from entering the dispenser. Absorb this paraffin with tissue or a paper towel. Do not remove the screen until the residual paraffin has been removed. The interior surfaces of the reservoir can then be cleaned with a tissue

8.23 Forceps Holder: The forceps holder is often a source of contamination and extremely susceptible to dirt. Therefore, clean the forceps holder thoroughly.

8.24 Paraffin collection tray: Before the paraffin collection tray drawers can be emptied any excess paraffin in the work area must be removed with cellulose wadding in order to prevent any paraffin from penetrating into the instrument Remove and empty the paraffin collection trays while they are warm. The paraffin in the collection trays must not be reused. The danger of paraffin carry-over into the instrument. Empty both paraffin collection trays regularly in order to prevent them from overflowing into the instrument. While emptying intervals may vary depending on use, the trays should be emptied at least daily.

D. Maintenance

8.25 Clean the instrument daily with care

8.26 Regularly remove dust from the ventilation slots on the back of the instrument with a brush or vacuum cleaner

8.27 The instrument should be inspected at least once a year by an authorized technician.

END OF DOCUMENTS

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