Leica IP S User manual

Leica IP S
Printer for slides
The Pathology Company
Instructions for Use
English
Order No.: 14 0601 80101 - Revision I
Always keep this manual near the instrument.
Read carefully before working with the instrument.
Version 2.0, Revision I - 02.2018

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

4Version 2.0, Revision I
Table of Contents
1. Important Information ................................................................................................................................ 6
1.1 Symbols and their meanings.......................................................................................................................... 6
1.2 Qualification of personnel.............................................................................................................................. 9
1.3 Intended use of instrument............................................................................................................................ 9
1.4 Instrument type.............................................................................................................................................. 10
2. Safety .......................................................................................................................................................... 11
2.1 Safety instructions......................................................................................................................................... 11
2.2 Warnings......................................................................................................................................................... 12
3. Instrument Components and Specifications........................................................................................ 14
3.1 Overview – instrument.................................................................................................................................. 14
3.2 Technical data................................................................................................................................................ 17
3.3 Print specifications........................................................................................................................................ 18
3.3.1 Requirements for specimen slides ............................................................................................................. 19
3.3.2 Print specifications........................................................................................................................................ 20
3.3.3 Printing bar code ........................................................................................................................................... 21
4. Instrument Setup....................................................................................................................................... 24
4.1 Site requirements .......................................................................................................................................... 24
4.2 Unpacking the instrument............................................................................................................................ 24
4.2.1 Installing the printer...................................................................................................................................... 26
4.3 Standard delivery........................................................................................................................................... 27
4.4 Installing the manual unload station .......................................................................................................... 28
4.5 Automated unload station (optional).......................................................................................................... 29
4.6 Installing/exchanging the flash bulb .......................................................................................................... 30
4.7 Filling and inserting the magazines ............................................................................................................ 33
4.8 Electrical connection.................................................................................................................................... 34
4.9 Exchanging the transport cartridge for an ink cartridge ........................................................................ 36
4.10 Installing the printer driver........................................................................................................................... 42
5. Operation.................................................................................................................................................... 43
5.1 Control panel functions................................................................................................................................. 43
5.2 Display indications ........................................................................................................................................ 49
5.3 Alarm functions.............................................................................................................................................. 50
5.4 Printer driver settings ................................................................................................................................... 51
6. Cleaning and Maintenance..................................................................................................................... 55
6.1 Cleaning the instrument................................................................................................................................ 55
6.2 Cleaning the print head................................................................................................................................. 57
6.3 Exchanging the cartridge............................................................................................................................. 60
6.3.1 Removing the used ink cartridge ................................................................................................................ 60
6.3.2 Inserting the new ink cartridge................................................................................................................... 61
6.3.3 Removing the protective cap....................................................................................................................... 61
6.4 General maintenance.................................................................................................................................... 61
6.5 Storing the instrument .................................................................................................................................. 61
7. Troubleshooting ........................................................................................................................................ 67

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Leica IP S
Table of Contents
7.1 Malfunctions................................................................................................................................................... 67
7.2 Status messages............................................................................................................................................ 68
7.3 Error messages.............................................................................................................................................. 69
7.4 Changing the flash bulb................................................................................................................................ 72
7.5 Power failure.................................................................................................................................................. 72
7.6 Replacing the secondary fuses................................................................................................................... 73
8. Warranty and Service .............................................................................................................................. 75
9. Decontamination Certificate .................................................................................................................. 76

6Version 2.0, Revision I
Important Information
1
1. Important Information
1.1 Symbols and their meanings
Warning
Leica Biosystems GmbH assumes no liability for consequential loss or damage due to failure to observe
the following instructions, particularly in relation to transportation and package handling, and failure to
observe the instructions for handling the instrument carefully.
Symbol: Title of the symbol: Warning
Description: Warnings appear in a gray box and are marked by a
warning triangle.
Symbol: Title of the symbol: Note
Description: Notes, i. e. important user information, appear ina
gray box 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: Function key
START Description: Fuction keys to be pressed on the instrument are
displayed as capital letters and bold, black text.
Symbol: Title of the symbol: Software key and/or Display Messages
Ready Description: Software keys to be pressed on the display and/or
messages on the display are displayed as bold, gray
text.
Symbol: Title of the symbol: Warning, hot surface
Description: Instrument surfaces which become hot during
operation are marked with this symbol. Avoid direct
contact to prevent risk of burning.
Symbol: Title of the symbol: Warning, risk of electric shock
Description: Instrument surfaces or areas which become
energized during operation are marked with this
symbol. Therefore, direct contact is to be avoided.
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.
Symbol: Title of the symbol: RCM Compliance Mark

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Leica IP S
Important Information 1
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.
Symbol: Title of the symbol: CE Compliance
Description: The CE marking is the manufacturer's declaration
that the medical product meets the requirements of
the applicable EC directives.
Symbol: Title of the symbol: CSA Statement (Canada/USA)
Description: The CSA test mark means that a product has
been tested and fulfills the applicable safety
and/or performance standards, including the
relevant standards defined or administered by the
American National Standards Institute (ANSI),
Underwriters Laboratories (UL), the Canadian
Standards Association (CSA), the National Sanitation
Foundation International (NSF) and others.
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: The WEEE symbol, indicating separate collection
for WEEE - Waste of electrical and electronic
equipment, consists of the crossed-out wheeled bin
(§ 7 ElektroG).
Symbol: Title of the symbol: Alternating current
Symbol: Title of the symbol: Article number
Description: Indicates the manufacturer's catalog number so that
the medical device can be identified.
Symbol: Title of the symbol: Serial number
Description: Indicates the manufacturer's serial number so that a
specific medical device can be identified.
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: ON (Power)

8Version 2.0, Revision I
Important Information
1
Description: The power supply is connected upon pushing the
power switch.
Symbol: Title of the symbol: OFF (Power)
Description: The power supply is disconnected upon pushing the
power switch.
Symbol: Title of the symbol: Fragile, handle with care
Description: Indicates a medical device that can be broken or
damaged if not handled carefully.
Symbol: Title of the symbol: Store dry
Description: Indicates a medical device that needs to be
protected from moisture.
Symbol: Title of the symbol: Stack limit
Description: It is not permitted to stack packages, and no loads
may be placed on top of the package.
Symbol: Title of the symbol: This way up
Description: Indicates correct upright position of the transport
package.
Symbol: Title of the symbol: Temperature limit for transport
Description: Indicates the temperature limits for transport to
which the medical device can be safely exposed.
Symbol: Title of the symbol: Humidity limitation for transport and storage
Description: Indicates the range of humidity for transport and
storage to which the medical device can be safely
exposed.
Symbol: Title of the symbol: IPPC symbol

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Leica IP S
Important Information 1
Description: The IPPC symbol includes
IPPC symbol
• Country code to ISO 3166, e.g. DE for Germany
• Regional identifier, e.g. NW for North
Rhine-Westphalia
• Registration number, uniquely number beginning
with 49.
• Treatment method, e.g. HT (heat treatment)
Symbol: Title of the symbol: Inflammable (Packaging Label)
Description: Package labeling in accordance with German
Hazardous Freight Ordinance Road and Rail (GGVSE)/
European Agreement concerning the International
Carriage of Dangerous Goods by Road (ADR) for
transporting hazardous goods.
Class 3: "FLAMMABLE LIQUID"
Symbol: Title of the symbol: Tilt Indicator
Description: 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.
1.2 Qualification of personnel
• The Leica IP S may be operated only by trained laboratory personnel.
• The instrument may be operated only according to the instructions contained in this Instruction for
Use.
1.3 Intended use of instrument
Leica IP S printer system for standard specimen slides.
• The instrument has been designed for use in pathology, histology, cytology, toxicology and similar
laboratories, and there only for standard specimen slides.
• Imprints of adequate quality and resistance to subsequent processing in tissue processors can only
be guaranteed when using the slides and reagents specified in (→p. 18 – 3.3 Print specifications).
• The instrument may be operated only according to the instructions contained in this Instructions for
Use.
Any other use of the instrument is considered improper

10 Version 2.0, Revision I
Important Information
1
Note
Proper and intended use includes the observance of all instructions in the operating manual and
compliance with all inspection and maintenance instructions.
1.4 Instrument type
All information provided in these Instructions for Use applies only to the instrument type indicated on
the title page.
A nameplate (→"Fig. 1") indicating the instrument serial number is attached to the back of the
instrument.
Fig. 1
Note
(→"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 (→p. 17 – 3.2 Technical data).