User Manual
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SL 800 Slit lamp
Documentation set
Copyright © 2022, Carl Zeiss Meditec AG, Jena Trademarks All trademarks mentioned in this document are the property of their respective owners.
Documentation set SL 800
Table of Contents
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 1.5.1 1.5.2
Conventions in this document ... Conventions in all text areas... Conventions in a course of action...
7 7 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 2.2.2
Intended use ... Patient population...
9 9
2.3 2.3.1
Responsibilities and duties of the responsible organization ... Notification to manufacturers and authorities...
10 11
2.4
Responsibilities and duties of the operator ...
11
2.5
Risk due to optical radiation...
13
2.6
Maintenance measures...
13
3
Description of the device... 15
3.1
Package check list ...
15
3.2
Device marking...
16
3.3
Structure of the device ...
19
3.4
Structure of the power supply unit...
20
3.5
Control elements ...
21
3.6 3.6.1
Control buttons and indicator lamps on the power supply unit... Configuration switches on power supply unit ...
26 27
3.7
Functional description ...
28
4
Installation ... 29
4.1
Installation safety ...
29
4.2
Installing the device...
30
4.3
Connecting the device ...
33
5
Before every use... 35
5.1
Preparation safety ...
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Table of Contents
Documentation set SL 800
6
Daily startup... 37
6.1
Switching on ...
7
Operation ... 39
7.1
Operation safety...
39
7.2
Adjusting the eyepieces and interpupillary distance ...
39
7.3
Positioning the diffusor ...
40
7.4
Setting the brightness ...
41
7.5
Positioning the patient ...
41
7.6
General notes on device operation ...
41
7.7
Reading the angular difference between illumination and observation unit...
42
7.8
Tonometry...
43
7.9
Gonioscopy...
44
7.10
Switching off the device ...
45
8
Cleaning and disinfection ... 47
8.1
Safety when cleaning and disinfecting the device ...
47
8.2
Cleaning ...
48
8.3
Disinfection ...
48
9
Maintenance ... 49
9.1
Testing electrical safety ...
49
9.2
Replacing the fuses...
51
9.3
Installing software updates for the device...
52
9.4
Creating a log file ...
52
9.5
Changing paper pads...
53
10
Troubleshooting... 55
10.1
Malfunctions ...
55
10.2
Service information ...
56
11
Technical data... 57
11.1
Essential performance ...
57
11.2 11.2.1 11.2.2
Regulatory information ... The device meets the following requirements and standards ... Device classification...
57 57 57
11.3
Illumination ...
58
11.4
Stereomicroscope ...
58
11.5
Instrument base...
58
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37
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Documentation set SL 800
Table of Contents
11.6
Headrest ...
59
11.7
Dimensions and weights...
59
11.8
Ambient conditions ...
59
11.9
Electrical specifications...
60
11.10
Electromagnetic compatibility ...
61
11.10.1 Ambient conditions for intended use... 11.10.2 Restrictions on essential performance...
61 62
12
Optional accessories... 67
12.1
Adjust the counterweight for the height adjustment of the instrument base ...
68
12.2
SL cam compact ...
70
12.3
Wide-field illumination ...
71
12.4
10x eyepiece, cross-hairs ...
72
12.5
Focusing rod...
73
12.6
AT 030 applanation tonometer ...
74
12.7
Fundus VarioView ...
74
12.8
Yellow filter aperture module...
79
12.9
Tube adapter 20°...
82
12.10
Beam splitter ...
85
12.11
Co-observation tube with eyepiece...
89
12.12
Fixation lamp...
91
12.13
Breathing shield...
92
12.14
Paper pads ...
92
12.15
Instrument table ...
93
13
Disposal of the device ... 95 Glossary ... 97 Index ... 99
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Empty page, for your notes
Documentation set SL 800
1 Notes on the instructions for use 1.1 Product name
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 functioning. Action
u
Read these instructions for use before setting up and using the device the first time.
u
Keep the instructions for use accessible for all users at all times.
u
Pass the instructions for use to future owners of the device.
1.4 Questions and comments Action
u
If you have any questions or comments concerning these Instructions for Use or the device itself, please 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: Conventions in this document [} 7]. This is highlighted text. This is software code or program text.
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1 Notes on the instructions for use 1.6 Applicable documents
Documentation set SL 800
Names of software dialogs, fields or menus, and software messages are marked by quotation marks: •
“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. u
CAUTION!
This is a measure with which hazards can be prevented.
This is warning information about hazards that can cause injuries if not avoided. The warning message names the possible consequences. u
NOTE
This is a measure with which hazards can be prevented.
This is warning information about hazards that can cause property damages if not avoided. The warning message names the possible consequences. u
This is a measure with which hazards can be prevented.
Prerequisite
þ This is a requirement that must be met before the start of a sequence of actions.
Action
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. ð This 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.
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2 Safety notes 2.1 Intended user profile
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 regulations, 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. u
However, 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.
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2 Safety notes 2.3 Responsibilities and duties of the responsible organization
Documentation set SL 800
2.3 Responsibilities and duties of the responsible organization Operating personnel The device may only be operated by instructed and trained personnel. u
Ensure that the operating personnel have been trained and instructed.
u
Ensure that the operating personnel have read and understood the instructions for use.
u
The instructions for use should be readily accessible to the operating personnel at all times.
u
To facilitate access for the entire operating personnel: If necessary, request further copies of the instructions for use from ZEISS.
u
Define the required skills for handling the device and provide information on who is authorized for which activities.
u
Define rules for reporting errors and damage, and provide information on these (see Notification to manufacturers and authorities [} 11]).
u
Regularly check compliance with the national laws and regulations 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. Accessories and additional equipment u
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If 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].
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Documentation set SL 800
2 Safety notes 2.4 Responsibilities and duties of the operator
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 In member states of the European Union, the responsible organization or person must report serious incidents to his competent authority. In all other countries, comparable rules apply where national legislation so requires.
2.4 Responsibilities and duties of the operator Electrical safety u
Switch 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.
u
Also switch off the device and disconnect it from the power supply before cleaning surfaces or accessories with a damp cloth.
u
Use only cables and plugs which are in perfect working condition.
u
Connect the device only to a power supply that corresponds to the values specified on the rating plate.
u
Never pull the cable to disconnect the plug.
u
Do not use multiple sockets.
u
Do not use extension cables.
u
Observe the instructions regarding electromagnetic compatibility (EMC).
u
Set the device up so that the power cable can be disconnected from the power supply quickly and without any supplementary means.
u
Connect 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.
u
Perform 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).
u
Do not touch the patient and the connections of the device simultaneously.
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2 Safety notes 2.4 Responsibilities and duties of the operator
Documentation set SL 800
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. u
Never open the device!
Ambient conditions u
Make sure that the installation requirements and the operation of the device meet the following requirements:
•
Low vibration
•
Clean environment
•
Avoid extreme mechanical loads
u
Do not operate or store the supplied devices in environmental conditions other than those prescribed.
u
Do 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).
u
Do not store or use this device in damp areas. Do not expose the device to water splashes or dripping or sprayed water.
u
Ensure that no liquids can enter the device.
u
Protect all optical exits (e.g. projector mirror, front lens, binocular tube of stereomicroscope) against contamination and avoid touching optical exits.
Decommissioning u
If 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
•
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 u
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Observe the symbols and labels attached to the device.
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Documentation set SL 800
2 Safety notes 2.5 Risk due to optical radiation
Transport u
Transport the device over long distances (e.g. move, return for repair, etc.) only in original packaging or special return packaging.
u
Contact your dealer or ZEISS Service.
2.5 Risk due to optical radiation This is a group 2 device according to ISO 15004-2 / ANSI Z80.36. 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 unnecessarily prolonged, and the brightness setting should not exceed what is needed to provide clear visualization of the target structures. 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 time required to exceed the ISO 15004-2 guideline is reduced to 48 seconds if cold white VarioLight is used exclusively, compared with 88 seconds if warm white VarioLight is used exclusively. 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. u
Never 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.
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Empty page, for your notes
Documentation set SL 800
3 Description of the device 3.1 Package check list
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.
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3 Description of the device 3.2 Device marking
Documentation set SL 800
3.2 Device marking Instrument base Labels
Explanation SL 800 type label Manufacturer 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
SL 800 identification label Catalogue number / part number
Serial number Date of manufacture
Unique device identification code (data matrix, serial number and plain text) Device identification code (data matrix, serial number and device name)
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Documentation set SL 800
3 Description of the device 3.2 Device marking
Labels
Explanation CSA approval for USA and Canada "Observe instructions for use" information label
Country of origin label Label for marking the device as a medical device 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.
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3 Description of the device 3.2 Device marking
Documentation set SL 800
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 Information sign "Disconnect device from the power supply before opening"
"Observe instructions for use" information label
Fuse identification label Unique device identification code (data matrix) for power supply unit
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Documentation set SL 800
3 Description of the device 3.3 Structure of the device
3.3 Structure of the device
2
1
3
4 Figure 1: Structure of the SL 800 1
Observation unit (stereomicroscope): comprising front lens, magnification changer, convenience interface, binocular tube and eyepieces
3
Headrest with chinrest (applied 4 part) and forehead rest (applied part)
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2
Illumination unit (slit projector)
Instrument base
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3 Description of the device 3.4 Structure of the power supply unit
Documentation set SL 800
3.4 Structure of the power supply unit 1 2
3
7
6
4
5
Figure 2: Connectors of the power supply unit
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1
Housing with four mounting holes
2
Slit lamp connection
3
Slit lamp connection (alternative)
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
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