Zeiss SL 800 Operator's manual

SL 800
Slit lamp
Documentation set

Copyright
© 2019, Carl Zeiss Meditec AG, Jena
Trademarks
All trademarks mentioned in this document are the property of
their respective owners.

Documentation set Table of contents
SL 800
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Table of contents
1 Notes on the instructions for use ................................................................. 7
1.1 Product name .......................................................................................................................7
1.2 Scope of application .............................................................................................................7
1.3 Purpose and storage of the documentation .........................................................................7
1.4 Questions and comments .....................................................................................................7
1.5 Conventions in this document ..............................................................................................7
1.5.1 Conventions in all text areas..............................................................................................................7
1.5.2 Conventions in a course of action......................................................................................................8
1.6 Applicable documents ..........................................................................................................8
2 Safety notes ................................................................................................. 9
2.1 Intended user profile ............................................................................................................9
2.2 Intended field of application.................................................................................................9
2.2.1 Intended use .....................................................................................................................................9
2.2.2 Patient population.............................................................................................................................9
2.3 Responsibilities and duties of the responsible organization ...............................................10
2.3.1 Notification to manufacturers and authorities..................................................................................11
2.4 Responsibilities and duties of the operator ........................................................................11
2.5 Risk due to optical radiation...............................................................................................13
2.6 Maintenance measures.......................................................................................................14
3 Description of the device............................................................................ 15
3.1 Package check list ..............................................................................................................15
3.2 Device marking...................................................................................................................15
3.3 Structure of the device .......................................................................................................17
3.4 Structure of the power supply unit.....................................................................................18
3.5 Control elements ................................................................................................................19
3.6 Control buttons and indicator lamps on the power supply unit..........................................24
3.6.1 Configuration switches on power supply unit ..................................................................................25
3.7 Functional description ........................................................................................................26
4 Installation ................................................................................................. 27
4.1 Installation safety ...............................................................................................................27
4.2 Installing the device............................................................................................................28
4.3 Connecting the device ........................................................................................................30
5 Before every use......................................................................................... 33
5.1 Preparation safety ..............................................................................................................33

Table of contents Documentation set
SL 800
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6 Daily startup............................................................................................... 35
6.1 Switching on ......................................................................................................................35
7 Operation................................................................................................... 37
7.1 Operation safety.................................................................................................................37
7.2 Adjusting the eyepieces and interpupillary distance ...........................................................37
7.3 Positioning the diffusor ......................................................................................................38
7.4 Setting the brightness ........................................................................................................39
7.5 Positioning the patient .......................................................................................................39
7.6 General notes on device operation .....................................................................................39
7.7 Reading the angular difference between illumination and observation unit.......................40
7.8 Tonometry..........................................................................................................................41
7.9 Gonioscopy.........................................................................................................................42
7.10 Switching off the device .....................................................................................................43
8 Cleaning and disinfection ........................................................................... 45
8.1 Safety when cleaning and disinfecting the device ..............................................................45
8.2 Cleaning .............................................................................................................................46
8.3 Disinfection ........................................................................................................................46
9 Maintenance .............................................................................................. 47
9.1 Testing electrical safety ......................................................................................................47
9.2 Replacing the fuses.............................................................................................................49
9.3 Installing software updates for the device..........................................................................50
9.4 Creating a log file ...............................................................................................................50
9.5 Changing paper pads..........................................................................................................51
10 Troubleshooting......................................................................................... 53
10.1 Malfunctions ......................................................................................................................53
10.2 Service information ............................................................................................................54
11 Technical specifications.............................................................................. 55
11.1 Essential performance ........................................................................................................55
11.2 Compliance.........................................................................................................................55
11.2.1 Directives with which the device is compliant ..................................................................................55
11.2.2 The device meets the following requirements and standards ...........................................................55
11.2.3 Device classification.........................................................................................................................55
11.3 Illumination ........................................................................................................................56
11.4 Stereomicroscope ...............................................................................................................56
11.5 Instrument base..................................................................................................................56

Documentation set Table of contents
SL 800
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11.6 Headrest .............................................................................................................................57
11.7 Dimensions and weights.....................................................................................................57
11.8 Ambient conditions ............................................................................................................57
11.9 Electrical specifications.......................................................................................................58
11.10 Electromagnetic compatibility ............................................................................................59
11.10.1 Ambient conditions for intended use...............................................................................................59
11.10.2 Restrictions on essential performance..............................................................................................60
12 Optional accessories................................................................................... 65
12.1 Adjust the counterweight for the height adjustment of the instrument base.....................66
12.2 SL cam compact .................................................................................................................68
12.3 Wide-field illumination .......................................................................................................69
12.4 10x eyepiece, cross-hairs ....................................................................................................70
12.5 Focusing rod.......................................................................................................................71
12.6 AT 030 applanation tonometer ..........................................................................................71
12.7 Fundus VarioView ..............................................................................................................72
12.8 Yellow filter aperture module.............................................................................................76
12.9 Tube adapter 20°................................................................................................................79
12.10 Beam splitter ......................................................................................................................81
12.11 Co-observation tube with eyepiece.....................................................................................84
12.12 Fixation lamp......................................................................................................................85
12.13 Breathing shield..................................................................................................................86
12.14 Paper pads .........................................................................................................................86
12.15 Instrument table .................................................................................................................86
13 Disposal of the device ................................................................................ 89
Glossary ..................................................................................................... 91
Keyword index ........................................................................................... 93

Empty page, for your notes

Documentation set 1 Notes on the instructions for use
SL 800 1.1 Product name
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1 Notes on the instructions for use
1.1 Product name
The SL800 slit lamp is referred to as "device" in these instructions
for use.
1.2 Scope of application
The present instructions for use apply to the SL800 slit lamp
carrying the following marking:
• Reference number: 2268-355
1.3 Purpose and storage of the documentation
These instructions for use explain the safety features, functions and
performance parameters of the device. They contain instructions on
the safe use of the device and identify measures for its care and
maintenance.
Correct operation of the device is imperative for its safe and
successful function.
uRead these Instructions for Use before setting up and using the
device the first time.
uKeep the instructions for use accessible for all users at all times.
uPass the instructions for use to future owners of the device.
1.4 Questions and comments
uIf you have questions or comments concerning these instruc-
tions for use or the device itself, contact ZEISS Service.
You can find the ZEISS contact partner for your country on the
following website: www.zeiss.com/med
1.5 Conventions in this document
Certain types of information are specially marked in this document
for better recognition.
1.5.1 Conventions in all text areas
• This is a list.
– This is a second level list.
This is a cross-reference: Questions and comments [}7].
This is bold type.
This is software code or program text.
Names of software dialogs, fields or menus, and software
messages are marked by quotation marks:

1 Notes on the instructions for use Documentation set
SL 8001.6 Applicable documents
8 / 94 000000-2268-355-DokS-GB-300719
• "View" menu.
• "Do you want to save the settings?"
The steps in menu and file paths are separated by slashes:
• "File / Save as"
• "My documents / Documents"
Keys, buttons, knobs, levers and other operating controls are
marked by square brackets:
• [START] key
• [Next] button
1.5.2 Conventions in a course of action
WARNING! This is warning information about hazards that can cause
death or severe injuries if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
CAUTION! This is warning information about hazards that can cause
injuries if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
NOTE This is warning information about hazards that can cause
property damages if not avoided.
The warning message names the possible consequences.
uThis is a measure with which hazards can be prevented.
þThis is a requirement that must be met before the start of a
sequence of actions.
1. This is a command.
2. CAUTION!This is a warning message about hazards that
can occur during a single action. This is a command.
ðThis is the result of a sequence of actions.
1.6 Applicable documents
Please observe also the instructions for use of any additional
equipment used with this device.

Documentation set 2 Safety notes
SL 800 2.1 Intended user profile
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2 Safety notes
2.1 Intended user profile
This device may only be installed, operated, used and maintained
by persons who have been properly trained or who have the
required knowledge and experience to do so. Please also adhere to
the national qualification guidelines applicable in your country.
Persons who operate the device must have knowledge of basic
ophthalmic examination and diagnosis methods as well as of
ophthalmic optics. This includes, among others, persons belonging
to the following occupational groups or their national equivalents:
• Ophthalmologist
• Optometrist
• Optician
2.2 Intended field of application
This device may only be set up, operated and used for the
indication for use specified herein and according to national regula-
tions, consistent with the applicable industry standards and
occupational safety and accident prevention regulations.
2.2.1 Intended use
This slit lamp is intended for eye examinations. It is used as a
universal device for observation, diagnosis, evaluation and
documentation of diseases or traumata that influence the structural
properties of the eye.
2.2.2 Patient population
The device was developed for a wide patient population. In
principle, people of all age groups can be examined.
uHowever, do not use this device in patients with the following
conditions:
• Patients who are unable to follow the instructions of the user,
• Patients who are unable to sit upright in front of the device,
• Patients who have forehead or chin injuries that prevent the
head from being supported on the forehead rest or chin rest.

2 Safety notes Documentation set
SL 8002.3 Responsibilities and duties of the responsible organization
10 / 94 000000-2268-355-DokS-GB-300719
2.3 Responsibilities and duties of the responsible
organization
Operating personnel
The device may only be operated by instructed and trained
personnel.
uEnsure that the operating personnel have been trained and
instructed.
uEnsure that the operating personnel have read and understood
the instructions for use.
uThe instructions for use should be readily accessible to the
operating personnel at all times.
uTo facilitate access for the entire operating personnel: If
necessary, request further copies of the instructions for use
from ZEISS.
uDefine the required skills for handling the device and provide
information on who is authorized for which activities.
uDefine rules for reporting errors and damage, and provide
information on these (see Notification to manufacturers and
authorities [}11]).
uRegularly check compliance with the national laws and regula-
tions concerning accident prevention and occupational health.
Complete the following checks before using the device:
• Visual inspection of the device and its accessories for damage,
as well as legibility of markings and labels
• Check the ventilation slits of the device. They should not be
covered or obstructed.
• Functional check of all switches, buttons, connectors and
indicator lamps on the device
Service life
The development, production and maintenance of the device,
together with associated risks, are based on an expected service life
of eight years, assuming that the device is operated and maintained
as prescribed in these instructions for use.
Changes to the product
Modifications to the product or failure to follow the manufacturer’s
instructions may substantially reduce the expected service life and
significantly increase the risks associated with the use of this device
and are thus not permitted.

Documentation set 2 Safety notes
SL 800 2.4 Responsibilities and duties of the operator
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Accessories and additional equipment
uIf you want to connect accessories or additional equipment
other than those described in these instructions for use to the
device: Contact your ZEISS representative [}7].
Additional equipment connected to medical electrical equipment
must demonstrably comply with the applicable IEC or ISO standards
(e.g. IEC60950-1 for data processing equipment).
Furthermore all configurations must comply with the normative
requirements for medical systems (see IEC 60601-1-1 or section 16
of IEC 60601-1).
If you connect additional devices to medical electrical systems, you
are a system configurer and are thus responsible for ensuring that
the system complies with the normative requirements for systems.
2.3.1 Notification to manufacturers and authorities
If an incident occurs in connection with this medical device which
affects the responsible organization or another person, the respon-
sible organization (or person responsible) must report this incident
to the manufacturer or seller of the medical product. In some
countries (e.g. the European Union) the responsible organization
must report this incident to the responsible authorities in the appli-
cable country.
2.4 Responsibilities and duties of the operator
Electrical safety
uSwitch the device off every time before disconnecting it from
the power supply, or if you are not going to use the device for
any length of time.
uAlso switch off the device and disconnect it from the power
supply before cleaning surfaces or accessories with a damp
cloth.
uUse only cables and plugs which are in perfect working
condition.
uConnect the device only to a power supply that corresponds to
the values specified on the rating plate.
uNever pull the cable to disconnect the plug.
uDo not use multiple sockets.
uDo not use extension cables.
uObserve the instructions regarding electromagnetic compati-
bility (EMC).
uSet the device up so that the power cable can be disconnected
from the power supply quickly and without any supplementary
means.

2 Safety notes Documentation set
SL 8002.4 Responsibilities and duties of the operator
12 / 94 000000-2268-355-DokS-GB-300719
uConnect the device using the power cable intended for use
with the device. If the device is mounted on an instrument
table qualified by Carl Zeiss Meditec, it will be powered
through this table.
uPerform the electrical installation in conformance to
IEC60364-7-710 or the applicable national regulations. This
includes the integration of a ground fault circuit interrupter
(GFCI).
uDo not touch the patient and the connections of the device
simultaneously.
The SL 800 is a device of protection class II. The third wire in the
power connection cable is only a functional earth wire.
Live parts are accessible inside the device. If you remove the
housing, you are exposed to the risk of an electric shock.
uNever open the device!
Ambient conditions
uMake sure that the installation requirements and the operation
of the device meet the following requirements:
• Low vibration
• Clean environment
• Avoid extreme mechanical loads
uDo not operate or store the supplied devices in environmental
conditions other than those prescribed.
uDo not operate the supplied devices, when powered by
electricity,
• on easily inflammable materials,
• in explosion risk areas (e.g. combustible mixture of anesthetic,
cleaning or disinfecting agents with air, oxygen or nitrous
oxide).
uDo not store or use this device in damp areas. Do not expose
the device to water splashes or dripping or sprayed water.
uEnsure that no liquids can enter the device.
uProtect all optical exits (e.g. projector mirror, front lens,
binocular tube of stereomicroscope) against contamination and
avoid touching optical exits.
Decommissioning
uIf one of the following events should occur, disconnect the
cable from the power supply, label the device clearly as being
out of service and report the problem to the ZEISS Service:
• Electric shock
• Penetration of substances

Documentation set 2 Safety notes
SL 800 2.5 Risk due to optical radiation
000000-2268-355-DokS-GB-300719 13 / 94
• Frequently occurring error messages
• Faults that cannot be remedied based on the information
provided in these instructions for use
If you use the device in combination with an accessory for image
documentation, please note that if the sensor for laterality
detection is defective, the right/left labeling of image data may be
incorrect. In this case, inform ZEISS Service about the problem and
check the right/left labeling of image data.
Symbols and labels
uObserve the symbols and labels attached to the device.
Transport
uTransport the device over long distances (e.g. move, return for
repair, etc.) only in original packaging or special return
packaging.
uContact your dealer or ZEISS Service.
2.5 Risk due to optical radiation
This is a group 2 device according to ISO 15004-2:2007.
The light emitted by this device is potentially hazardous. The longer
the duration of exposure, the greater the risk of ocular damage.
Exposure to light from this device when operated at maximum
intensity will exceed the safety guideline for the aphakic eye after
48 s.
Because prolonged intense light exposure can damage the retina,
the use of the device for ocular examination should not be unnec-
essarily prolonged, and the brightness setting should not exceed
what is needed to provide clear visualization of the target struc-
tures.
Some groups of people will be at greater risk due to anatomical
conditions (e.g. infants, aphakes and persons with diseased eyes).
The risk may also be increased if the patient being examined has
recently had any exposure to light (e.g. an eye examination or
treatment).
The device allows to illuminate the eye with two different white
tones using the VarioLight function.
The cold white VarioLight can offer an advantage when examining
transparent media in the anterior segment of the eye, while the
warm white VarioLight creates natural image effects when viewing
circulated tissue e.g. in the posterior segment of the eye. The time
required to exceed the ISO 15004-2:2007 guideline is reduced to
48 seconds if cold white VarioLight is used exclusively, compared
with 88 seconds if warm white VarioLight is used exclusively.

2 Safety notes Documentation set
SL 8002.6 Maintenance measures
14 / 94 000000-2268-355-DokS-GB-300719
Ratio for duration of exposure VarioLight
cold white [%] : warm white
[%]
cold white [s] warm white [s]
100 : 0 48 0
75 : 25 36 22
50 : 50 24 44
25 : 75 12 66
0 : 100 0 88
Table1: Examples of exposure duration up to the safety guideline
threshold when using warm and cold white light.
uNever look into the sun through the binocular tube and
eyepieces.
2.6 Maintenance measures
Maintenance procedures (maintenance and repairs) which are not
specified in these instructions for use may only be carried out by
persons authorized by Carl Zeiss Meditec and solely according to
the service instructions issued by Carl Zeiss Meditec. For planning
and implementing these maintenance and care procedures please
contact ZEISS Service or your local dealer.

Documentation set 3 Description of the device
SL 800 3.1 Package check list
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3 Description of the device
3.1 Package check list
SL 800 version for installation on an instrument table
• SL 800 slit lamp
• Binocular tube (convergent or parallel)
• 2 eyepieces
• Headrest
• Power supply unit
• Power supply cable
• Documentation set
• Mounting accessories
• Dust cover
When using the device mounted on an examination unit, an
optional cable extension set is available.
Depending on your order, additional optional components and
accessories may also be included in the delivery package.
3.2 Device marking
Instrument base
Labels Explanation
SL 800 type label
Manufacturer
Date of manufacture
Applied part type B
IP20 Ingress protection rating for housing (protected
against solid foreign bodies of ≥ 12.5 mm in
diameter, no protection against penetration of
water)
EU conformity symbol
Disposal advice for EU

3 Description of the device Documentation set
SL 8003.2 Device marking
16 / 94 000000-2268-355-DokS-GB-300719
Labels Explanation
SL 800 identification label
Catalogue number / part number
Serial number
Label with manufacturing date
"Observe user manual" information label
Label: According to Federal Law of the U.S.A. this device
may only be purchased by a physician or by order of a
physician.
CSA approval for USA and Canada
Power supply unit
Labels Explanation
Power supply unit type label
Manufacturer
Date of manufacture
IP20 Ingress protection rating for housing (protected
against solid foreign bodies of ≥ 12.5 mm in
diameter, no protection against penetration of
water)
Catalogue number / part number
Serial number
Device of protection class II
"Disconnect device from the power supply before opening"
information label
"Observe user manual" information label
Fuse identification label

Documentation set 3 Description of the device
SL 800 3.3 Structure of the device
000000-2268-355-DokS-GB-300719 17 / 94
Labels Explanation
Unique device identification code (data matrix) for power
supply unit
3.3 Structure of the device
2
4
3
1
Figure1: Structure of the SL 800
1 Observation unit (stereo-
microscope): comprising
front lens, magnification
changer, convenience
interface, binocular tube and
eyepieces
2 Headrest with chinrest
(applied part) and forehead
rest (applied part)
3 Illumination unit (slit
projector)
4 Instrument base

3 Description of the device Documentation set
SL 8003.4 Structure of the power supply unit
18 / 94 000000-2268-355-DokS-GB-300719
3.4 Structure of the power supply unit
4
3
6
2
1
5
1
7
Figure2: Connectors of the power supply unit
1 Housing with four mounting
holes
2 Slit lamp connection
3 Slit lamp connection (alter-
native)
4 Power input with power
input fuses
5 USB-B port for connection of
SL Workstation or external PC
6 USB-A port for fixation lamp
and wide-field illumination
7 EcoMode (external) for
connection of an external
switching device (sliding table
switch) when the device is
mounted on an examination
unit

Documentation set 3 Description of the device
SL 800 3.5 Control elements
000000-2268-355-DokS-GB-300719 19 / 94
3.5 Control elements
5
4
321
Figure3: Controls of the stereomicroscope
Pos. Name Explanation
1 Eyepieces with
eyecups
The eyecups help to find the ideal working
distance between user and eyepiece.
• Spectacle wearers should slide the
eyecups onto the eyepiece towards the
patient up to the stop.
• Non spectacle wearers should pull out
the eyecups up to the stop.
2 Binocular tube Convergent or parallel tube (for adaptation
to the interpupillary distance of the
operator)
3 Convenience
interface with
threaded pin
For attaching the binocular tube. The
convenience interface is already integrated
in some optional components and acces-
sories.
4 Mounting interface For attaching accessories (e.g. applanation
tonometer holder)
5 Magnification
changer
Rotary knob for manual magnification
change

3 Description of the device Documentation set
SL 8003.5 Control elements
20 / 94 000000-2268-355-DokS-GB-300719
1
4
10
5
2
3
7
8
9
11
6
Figure4: Display and control elements of the slit projector
Pos. Name Explanation
1 Scale for slit length
setting
Display of the adjusted slit length
2 Filter insertion lever Lever to set the examination illumination.
Setting options: red, blue, VarioLight cold
white, VarioLight warm white, green (red-
free)
3 Rotary knob for slit
length and blue
filter setting and
lever for slit rotation
Rotary knob for setting the slit length in
variable steps of 0.2/1/3/5/9/12 mm and
continuously from 1 mm to 12 mm, blue
filter. Lever for setting the slit rotation
continuously from 0° to 180° with stops at
45°/90°/135°
4 Scale to display the
slit rotation
Display range: 0° to 180° with 5° scale
gradation
5 Mirror
6 Mirror base Allows decentering of the slit illumination
by pivoting