Leica HistoCore Arcadia C Instructions For Use Manual

HistoCore Arcadia C

Cold Plate

Instructions for Use
English

Order No.: 14039380101 - Revision K

Always keep this manual with the instrument.
Read carefully before working with the instrument.

Version 1.8, Revision K - 10.2018

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HistoCore Arcadia C

The information, numerical data, notes and value judgments contained in this Instructions for Use
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 Instructions for Use periodically and on an ongoing
basis according to the latest technical developments, nor to provide our customers with additional
copies, updates etc. of this Instructions for Use.

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 Instructions for Use. 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 Instructions for Use.

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 Biosystems 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.

Note

Leica Biosystems Nussloch GmbH
Heidelberger Str. 17 - 19
D-69226 Nussloch
Germany
Tel.: +49 - (0) 6224 - 143 0
Fax: +49 - (0) 6224 - 143 268
Web: www.LeicaBiosystems.com

Assembly contracted to Leica Microsystems Ltd. Shanghai

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Version 1.8, Revision K

Table of contents

1. Important Information ................................................................................................................................ 5

1.1 Naming conventions ....................................................................................................................................... 5

1.2 Symbols in the text and their meanings ....................................................................................................... 5

1.3 Instrument type ................................................................................................................................................ 8

1.4 Intended use of instrument ............................................................................................................................ 8

1.5 Qualification of personnel .............................................................................................................................. 8

2. Safety ........................................................................................................................................................... 9

2.1 Safety notes ...................................................................................................................................................... 9

2.2 Warnings ......................................................................................................................................................... 10

3. Instrument Components and Specifications ........................................................................................12

3.1 Overview – instrument components........................................................................................................... 12

3.2 Main features of the instrument.................................................................................................................. 12

3.3 Technical Data ............................................................................................................................................... 12

4. Setting up the instrument ........................................................................................................................ 14

4.1 Site requirement ............................................................................................................................................ 14

4.2 Standard delivery – packing list .................................................................................................................. 14

4.3 Unpacking and installation........................................................................................................................... 15

4.4 Moving the instrument .................................................................................................................................. 17

4.5 Power supply .................................................................................................................................................. 18

5. Operation .................................................................................................................................................... 19

5.1 Switching the instrument on ....................................................................................................................... 19

5.2 Replacing the secondary fuse ..................................................................................................................... 19

6. Maintenance and Cleaning .....................................................................................................................21

6.1 Cleaning the instrument................................................................................................................................ 21

6.2 Maintenance instructions ............................................................................................................................ 21

7. Troubleshooting ........................................................................................................................................ 22

8. Warranty and Service .............................................................................................................................. 23

9. Decontamination Confirmation .............................................................................................................. 24

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HistoCore Arcadia C

Important Information

1

1. Important Information

1.1 Naming conventions

Note

The full name of the device is HistoCore Arcadia C Cold Plate. The device is called
HistoCore Arcadia C to ensure that the Instructions for Use are well legible.

1.2 Symbols in the text and their meanings

Symbol: Title of the symbol: Warning

Description: Warnings appear in a white box, orange header and

are marked by a warning triangle.

Symbol: Title of the symbol: Note

Description: Notes, i. e. important user information, appear in

a white box, blue header and are marked by an
information symbol.

Symbol: Title of the symbol: Item number

→ "Fig. 7-1" Description: Item numbers for numbering illustrations. Numbers in

red refer to item numbers in illustrations.

Symbol: Title of the symbol: Caution

Description: Caution, consult the instructions for use for

cautionary information.

Symbol: Title of the symbol: Power on

Symbol: Title of the symbol: Power off

Symbol: Title of the symbol: Consult Instructions for Use

Description: Indicates the need for the user to consult the

Instructions for Use.

Symbol: Title of the symbol: Manufacturer

Description: Indicates the manufacturer of the medical product.

Symbol: Title of the symbol: Manufacturing date

Description: Indicates the date when the medical device was

manufactured.

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Version 1.8, Revision K

Important Information

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Symbol: Title of the symbol: Alternating current

Symbol: Title of the symbol: PE terminal

Symbol: Title of the symbol: Article number

Description: Order number for standard delivery or accessories.

Symbol: Title of the symbol: Serial number

Description: Designates the serial number of the instrument.

Symbol: Title of the symbol: China RoHS

Description: Environmental protection symbol of the China RoHS

directive. The number in the symbol indicates the
"Environment-friendly Use Period" of the product in
years. The symbol is used if a substance restricted
in China is used in excess of the maximum permitted
limit.

Symbol: Title of the symbol: WEEE Symbol

Description: 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.

Symbol: Title of the symbol: CE Compliance

Description: CE labeling shows that the product corresponds to

one or more applicable European directives.

Symbol: Title of the symbol:

This product fulfills the requirements of the CAN/
CSA-C22.2 No. 61010.

Symbol: Title of the symbol: Fragile, handle with care

Description: The package contents are fragile and must be

handled with care.

Symbol: Title of the symbol: Keep dry

Description: The package must be kept in a dry environment.

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HistoCore Arcadia C

Important Information

1

Symbol: Title of the symbol:

Indicates the correct upright position of the package.

Symbol: Title of the symbol:

It allows maximum 2 stacks layers.

Symbol: Title of the symbol:

Indicates the temperature range permitted for storing
and transporting the package.

Minimum -29 °C

Maximum +50 °C

Symbol: Title of the symbol:

Indicates the temperature range permitted for storing
the package.

Minimum +5 °C

Maximum +50 °C

Symbol: Title of the symbol:

Indicates the humidity range permitted for storing
and transporting the package.

Minimum 10 % r.H.

Maximum 85 % r.H

Symbol: Title of the symbol:

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.

Symbol: Title of the symbol:

In the Shockwatch system, a shock dot shows
shocks or impacts that are above a specified
intensity through red coloration. Exceeding a defined
acceleration (g value) causes the indicator tube to
change color.

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Version 1.8, Revision K

Important Information

1

Symbol: Title of the symbol:

Indicates the item can be recycled where correct
facilities exist.

Symbol: Title of the symbol: Regulatory Compliance Mark (RCM)

Description The Regulatory Compliance Mark (RCM) indicates a

device’s compliance with applicable ACMA technical
standards of New Zealand and Australia - that is, for
telecommunications, radio communications, EMC
and EME.

1.3 Instrument type

All information provided in these Instructions for Use applies only to the instrument type indicated on
the cover page.

A nameplate is attached to the back of the instrument and a serial number label is on the side of the
instrument.

1.4 Intended use of instrument

The HistoCore Arcadia C is a cold plate for chilling and blocking out histological tissue samples in
paraffin blocks.

Any other use of the instrument will be considered as improper use!

1.5 Qualification of personnel

• The HistoCore Arcadia C 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.