Leica Keratoscope Operating manual

MEDICAL DIVISION
User Manual / Installation Manual
10 743 816 – Version 01
LeicaKeratoscope

II 10 743 816 / Leica Keratoscope / Version 01
Thank you for purchasing a Leica Keratoscope.
In developing our systems, we have placed great emphasis on simple, self-
explanatory operation. Nevertheless, we suggest studying this manual in
detail in order to utilize all the benefits of your Leica Keratoscope.
For valuable information about Leica Microsystems products and services and
the address of your nearest Leica representative, please visit our website,
www.leica-microsystems.com.
Thank you for choosing our products. We hope that you will enjoy the quality
and performance of your Leica Keratoscope.
Leica Microsystems (Schweiz) AG
Medical Division
CH-9435 Heerbrugg

10 743 816 / Leica Keratoscope / Version 01 1
Contents
1 Introduction 2
1.1 About this user manual 2
1.2 Product identification 2
1.3 Symbols in this manual 2
1.4 Design and function 2
2 Safety notes 3
2.1 Intended use 3
2.2 Information for the person responsible for the instrument 3
2.3 User qualifications 3
2.4 Directions for the user of the instrument 3
2.5 Dangers of use 3
3 Assembly 5
3.1 Preparation 5
3.2 Assembly 5
3.3 Concluding tasks 5
4 Operation 6
4.1 Before the operation 6
4.2 During the surgery 6
4.3 Lamp replacement on the surgical microscope 6
5 Care and Maintenance 7
5.1 Maintenance instructions 7
5.2 Maintenance 7
5.3 Table: Sterilization 7
5.4 Disposal 7
6 What to do if...? 8
7 Specifications 9
7.1 Mechanical data 9
7.2 Optical data 9
7.3 Ambient conditions 9
7.4 Electrical data 9
7.5 Standards fulfilled 9
7.6 Dimensional drawing 9

2 10 743 816 / Leica Keratoscope / Version 01
1 Introduction
1.4 Design and function
1.4.1 Standard delivery
1
2
3
5
4
1 Cover, sterilizable (3 pcs.)
2 Leica Keratoscope
3 Metal clip for cable fastening including toothed disk and fastening
screw (2 pcs. each)
4 2.5 mm Allen key
5 CAN connecting cable
1.4.2 Function
The Leica Keratoscope is an accessory for the Leica M844, M822, M822 H and
M820 surgical microscopes. It consists of LEDs arranged in a ring form.
When the light from the LEDs hits the cornea, it appears as a circle. Any
deviations from the circular shape indicate a deformation of the cornea.
The Leica Keratoscope can make qualitative assessments only; it is
not capable of quantitative ones.
1.4.3 Combinations for use with the
Leica Keratoscope
The Leica Keratoscope is fastened directly to the objective. The following
components and accessories can be operated with the Leica Keratoscope:
• Leica RUV800 (can be installed at the same time only)
• Slit illuminator (if swung to the side)
• OCULUS BIOM (can be installed at the same time only)
• Sterile drape (can be installed at the same time only)
Your Leica representative will be pleased to help you select the
appropriate accessories.
1.1 About this user manual
This user manual contains important safety notes as well as
information on using the instrument (see the chapter "Safety
notes").
 Before setting up the product, carefully read through the user
manual.
1.2 Product identification
The model and serial number of your product are shown on the nameplate.
 Enter this data in this User Manual / this Installation Manual and always
refer to it when you contact us or the service workshop regarding any
questions you may have.
Type Serial No.
... ...
1.3 Symbols in this manual
The symbols used in this manual have the following meaning:
Symbol Signal word Meaning
Warning Indicates an imminently hazardous situation
or improper use that could result in serious
personal injuries or death.
Caution Indicates a potentially hazardous situation or
improper use that could result in only minor
to moderate personal injuries.
Note This indicates a potentially hazardous
situation that could result in property
damage or harm to the environment.
Information about use that helps the user to
employ the product in a technically correct
and efficient way.
 Action required; this symbol indicates that
you need to perform a specific action or series
of actions.

10 743 816 / Leica Keratoscope / Version 01 3
2.3 User qualifications
 The Leica Keratoscope may only be used by physicians and medical
assistance personnel with appropriate qualifications who have been
instructed in the use of the instrument. Specific training is not required.
2.4 Directions for the user of the instrument
 Follow the instructions described here.
 Follow the instructions given by your employer regarding the
organization of work and safety at work.
2.5 Dangers of use
2.5.1 Phototoxic damage to the retina during eye
surgery
• The Leica Keratoscope is an accessory for a Leica surgical microscope for
ophthalmology.
CAUTION
Damage to the eyes due to prolonged exposure!
The light of the instrument may be harmful.
Risk of eye damage increases with the duration of exposure.
 During exposure to the light from the radiation, do not exceed the
hazard reference values (DIN EN ISO 15004-2:2007). An exposure to
this instrument for longer than 120 min at maximum output
power exceeds the exposure limits.
 Switch the Leica Keratoscope off after use.
 Observe the warning messages in the User Manual of the
Leica surgical microscope.
2.1 Intended use
• The Leica Keratoscope is an accessory for a Leica surgical microscope for
ophthalmology.
• The Leica Keratoscope consists of a ring of LEDs that generate light that
can make a deformation of the cornea visible during surgery.
• The Leica Keratoscope may be used in enclosed rooms only
• The Leica Keratoscope is subject to special precautions for electromagnetic
compatibility (EN 60601-1-2, 2nd / 3rd edition).
It must be installed and commissioned in accordance with the
guidelines and manufacturer's declarations and recommended safety
distances. These must be taken from the user manual of the Leica
surgical microscope.
2.2 Information for the person responsible
for the instrument
 Ensure that the Leica Keratoscope is used only by persons qualified to do so.
 Make sure that this user manual / this installation manual are always
available at the Leica Keratoscope.
 Carry out regular inspections to make certain that the authorized users
are adhering to safety requirements.
 When instructing new users, do so thoroughly and explain the
meanings of the warning signs and messages.
 Allocate responsibilities for commissioning, operation and maintenance.
Monitor compliance with this.
 Only use the Leica Keratoscope if it is free of defects.
 If any faults develop which might put the safety of people at risk,
immediately contact your Leica representative.
 If you use accessories from other manufacturers with the
Leica Keratoscope, make sure that these manufacturers confirm
that the combination is safe to use. Follow the instructions in
the User Manual for those accessories.
 Modifications and maintenance work on the Leica Keratoscope may only
be performed by professionals expressly authorized by Leica.
 Only original Leica replacement parts may be used in servicing the
product.
 After service work or technical modifications, the device must be
readjusted in accordance with our technical specifications.
 If the instrument is modified or serviced by unauthorized persons,
is improperly maintained (as long as maintenance was not carried out
by us), or is handled improperly, Leica will not accept any liability.
 The effect of the Leica Keratoscope on other instruments has been tested
as specified in EN 60601-1-2. The Leica Keratoscope passed the emission
and immunity test. Comply with the usual precautionary and safety
measures relating to electromagnetic and other forms of radiation.
2 Safety notes

4 10 743 816 / Leica Keratoscope / Version 01
2 Safety notes
2.5.2 General dangers during use
WARNING
Risk of injury from damaged components or accessories.
 Do not use the Leica Keratoscope, surgical microscope, and
accessories unless they are in proper condition.
 Read the following pages thoroughly.
WARNING
Risk of injury through surgical microscope moving down!
 Complete all preparations and adjustments to the stand before
the operation.
• Never change the accessories or attempt to rebalance the
microscope while it is above the field of operation.
• Before re-equipping, always lock the swing arm.
• After re-equipping, always rebalance the microscope on the
swing arm.
WARNING
Risk of injury from parts falling down!
 Complete all preparations and adjustments to the optics carrier
before the operation.
 Never rebalance or re-equip the optical components and
accessories with the instrument over the field of operation.
 Before the operation, make sure that the optical components
and accessories are installed properly.
 Before re-equipping during the operation, first swing the
microscope away from the operating field.

10 743 816 / Leica Keratoscope / Version 01 5
3.1 Preparation
 Remove any accessories from the objective, refer to the instructions
in the respective Installation Manual.
3.2 Assembly
7
6
3
5
2
3
 Attach the Leica Keratoscope (2) to the objective so that the on/off
switch (6) points to the left side.
 Push the Leica Keratoscope onto the objective until it is flush with the
bottom of the surgical microscope.
 Fasten the Leica Keratoscope to the objective using 3 internal hexagon
pins (7). Tighten the internal hexagon pins so that the Leica Keratoscope
no longer can become detached from the objective.
 Unscrew the screws (3) on the bottom of the microscope.
WARNING
Risk of injury from falling mounting hardware.
 Use toothed disks.
 Tighten screws with a torque of 0.7 Nm.
 Route the CAN connecting cable (5) on the bottom of the microscope
and fasten it using the provided screws, toothed disks and metal clip (3)
and a screwdriver (tightening torque: 0.7 Nm).
 Insert the CAN connecting cable at the CAN socket of the surgical
microscope.
If the CAN socket is already assigned, you can create a second CAN
connection using a Y-cable.
The Leica Keratoscope is supplied with voltage by the surgical
microscope. No additional connection work is necessary.
3.3 Concluding tasks
 Reinstall the accessories you removed previously; refer to the
information in the corresponding Installation Manuals.
3 Assembly

6 10 743 816 / Leica Keratoscope / Version 01
4.1 Before the operation
4.1.1 Function check
6
 Switch on the surgical microscope.
 Switch on the Leica Keratoscope using the on/off switch (6).
The LEDs are illuminated.
WARNING
Risk of injury from the Leica Keratoscope falling down.
 Before each operation, check the Leica Keratoscope and the
objective to make sure that they are firmly seated.
 If the Leica Keratoscope moves when it is switched on or off,
the Leica Keratoscope and the objective must be checked
and fastened securely.
4.1.2 Sterility
 Place the sterilized drape on the on/off switch (6).
Sterile operation of the Leica Keratoscope is possible.
4.2 During the surgery
4.2.1 Switching on the Leica Keratoscope
During the operation, the Leica Keratoscope can be switched on for testing
purposes.
 Switch on the Leica Keratoscope using the on/off switch (1).
The light of the LEDs should appear as a circle. Any deviations from
the circular shape indicate a deformation of the cornea.
4 Operation
CAUTION
Damage to the eyes due to prolonged exposure!
The light of the instrument may be harmful.
Risk of eye damage increases with the duration of exposure.
 During exposure to the light from the radiation, do not exceed the
hazard reference values (DIN EN ISO 15004-2:2007).
An exposure to this instrument for longer than 120 min at
maximum output power exceeds the exposure limits.
 Switch the Leica Keratoscope off after use.
 Observe the warning messages in the User Manual of the
Leica surgical microscope.
4.2.2 Switching off the Leica Keratoscope
 Switch off the Leica Keratoscope after use using the on/off switch (6).
4.3 Lamp replacement on the surgical
microscope
If using the surgical microscope with the Leica Keratoscope, when
changing the lamp, you have to hold the connecting cable of the
Leica Keratoscope to the side.

10 743 816 / Leica Keratoscope / Version 01 7
5.1 Maintenance instructions
 Keep accessories in a dust-free place when not in use.
 Remove dust with bellows and a soft brush.
 Protect the Leica Keratoscope from moisture, vapors, acids, alkalis,
and corrosive substances
 Do not keep chemicals near the instrument.
 Protect the Leica Keratoscope from improper handling.
 Do not assemble other plugs, or unscrew optical systems and
mechanical parts, unless explicitly instructed to do so in these
instructions.
 Protect the Leica Keratoscope from oil and grease.
 Never oil or grease the guide surfaces or mechanical parts.
 Remove coarse debris with a moistened disposable cloth.
 To disinfect the Leica Keratoscope, use compounds from the surface
disinfectant group based on the following active ingredients:
• Aldehydes
• Alcohols
• Quaternary ammonium compounds
Due to potential damage of the materials, never use products
based on:
• Halogen-donating compounds
• Strong organic acids
• Oxygen-donating compounds
Follow the disinfectant manufacturer’s instructions.
5 Care and Maintenance
5.2 Maintenance
 The Leica Keratoscope is basically maintenance-free.
5.3 Table: Sterilization
Article No. 10702693
Designation Cover, sterilizable
Permissible sterilization
methods
Steam (autoclave) Ethylene oxide
134 °C, t > 10 min. max. 60 °C
Products with optical components can be sterilized with steam if the
conditions listed above are complied with. However, this may lead to the
formation of a layer of dots and streaks on the glass surface, which may
reduce the optical performance.
For the details, refer to the user manual of the Leica surgical microscope.
5.4 Disposal
 Observe the relevant federal regulations when disposing
of the device.
 Suitable waste disposal companies are to be used.
 The unit packaging is to be recycled.

8 10 743 816 / Leica Keratoscope / Version 01
Problem Cause Remedy
No light on the Leica Keratoscope • Leica Keratoscope not switched on  Switch on the Leica Keratoscope.
• Leica Keratoscope connecting cable not
plugged in correctly
 Check the wiring of the Leica Keratoscope.
• Surgical microscope not switched on  Switch on the surgical microscope.
• Surgical microscope not properly connected  Check the voltage connection of the surgical
microscope.
If you still have problems, contact the Leica representative.
6 What to do if...?

10 743 816 / Leica Keratoscope / Version 01 9
7.1 Mechanical data
Connection to Leica surgical microscopes with objectives
with a diameter of 81 mm and CAN socket
(M844 and M820 with manufacturing date
after August 23, 2005)
Weight 0.2 kg
7.2 Optical data
Ring illuminator 50 red LEDs (614 – 634 nm)
7.3 Ambient conditions
Use and storage same as for the Leica surgical microscope
7.4 Electrical data
Connection on the CAN bus of the Leica surgical
microscope
Power supply 24 V, max. 1.2 W
7.5 Standards fulfilled
CE conformity Medical Devices Directive 93/42/EEC including
amendments. Medical electrical devices, Part 1:
General Requirements for Safety IEC 60601-1;
EN 60601-1; UL60601-1; CAN/CSA-C22.2 NO.
601.1-M90. Photobiological safety of lamps and
lamp systems IEC 62471.
Classification Class I, in compliance with Appendix IX,
Rule 1, and Rule 12 of the Directive.
Furthermore, all standards listed in the user manual of the Leica surgical
microscope are fulfilled.
7.6 Dimensional drawing
7 Specifications

www.leica-microsystems.com
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foundation of Leica Microsystems‘ innovative strength. On this basis, we
have developed our five corporate values: Pioneering, High-end Quality,
Team Spirit, Dedication to Science, and Continuous Improvement.
MEDICAL DIVISION
What does a surgeon expect from an outstanding surgical microscope?
Sharp, clear images, and a modular system aligned with the surgeon and
OR staff needs.
Innovations for your practice
From the first surgical microscope with widefield optics in the 1980s to the
first microscopes with Horizontal Optics and with LED illumination, Leica
Microsystems has been at the forefront of innovation in the development of
surgical microscopes.
HD video, fluorescence and retinal viewing systems also demonstrate the
continued innovative nature of the Leica team. We strive to provide the
surgeon with leading edge technology to enhance performance, surgeon
comfort, and patient outcomes.
Leica Microsystems – an international company with a strong network of
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Letzte_SOM_en.indd 2 21.08.12 17:35
10 743 816en/01 • Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2012 • Printed – VIII.2012 – Editing for printout by galledia • Subject to modifications.
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