Microscopio Karl Kaps

SOM 62/32/22
LED
Instructions for use
Karl Kaps GmbH & Co KG

Schulstrasse 57 Tel. + 49 (0) 6441 / 80704-0 service@kaps-optik.de
35614 Asslar
Fax. + 49 (0) 6441 / 85 9 85 www.kaps-optik.de
Germany
Instructions for use SOM 62/32/22 LED
Contents
1 General 1
2 Symbols used and what they mean 2
3 Warning and safety advice 4
3.1 Installation instructions 4
3.2 Notes for use and disposal 5
4 Directives, laws and standards 6
5 Delivery state 6
5.1 Deliverables 6
5.1.1 Deliverables for SOM 62 LED 6
5.2 Transportation/packaging/unpacking/checking 7
5.2.1 Unpacking 7
6 Intended use 7
7 Installation 8
7.1 Installation of SOM62 8
7.1.1 Installation of wheeled stand and column 8
7.1.2 Installation of swivel arm, suspension arm and microscope 9
7.2 Installation of SOM 32 10
7.2.1 Installation of the ceiling bracket 10
7.2.3 Connecting up to the voltage supply 12
7.3 Installation of SOM 22 13
7.3.1 Fitting of the wall bracket 13
8 Device description 14
8.1 Identification and nameplates 14
8.2 Controls 15
8.2.1 Controls 15
8.3 Medical performance data 16
8.4 Additional loads 16
8.5 Suspension arm adjustments 16
9 Preparation 17
9.1 Power supply 17
9.2 Brakes 17
9.3 Adjusting eye distance 17
9.4 Focusing 18
9.5 Checklist 18
10 Operation 19
10.1 Transport position / rest position (SOM62 LED only) 19
10.2 Replacing objective and eyepieces 20
10.3 Switching the device on and off 21
10.4 Brightness control 22
10.5 Magnification adjustment 23
10.5.1 Magnification setting on the changer 23
10.5.2 Magnification setting on the zoom unit 23
10.6 Swivelling in/out the filter 24
SOM 62/32/22 LED EN 2017-03

10.7 Removing/exchanging the binocular tube 24
11 Shutting the system down 25
12 Cleaning and maintenance 25
12.1 Fuse replacement 25
12.2 Disinfection and sterilisation 26
12.3 Cleaning optical surfaces 26
12.4 Cleaning painted parts 26
12.5 Maintenance 26
12.6 Replacing LEDs 26
12.7 Replacing the power lead 26
13 Disposal 26
14 Accessories 27
15 When faults occur 28
15.1 Summary of potential faults 28
16 Technical description 29
16.1 Technical details 29
16.2 Dimensions 30
16.2.1 SOM 62 LED 30
16.2.2 SOM 32 LED 31
16.2.3 SOM 22 LED 31
17 Declaration of conformity 32
18 Warranties 33
SOM 62/32/22 LED DE 2017-03

1 General
Thank you for selecting one of our quality products. Kaps devices combine excellent illumination,
easy and exact positioning, and very good optical performance in a variable and modular system.
Your product can be subsequently aligned to different requirements at any time without problem.
The ergonomic design of our products enables users to work without becoming tired. A brilliant 3-
dimensional image with high depth of focus enables best possible success quotas in your
diagnostics.
This instruction manual is an integral part of the deliverables and is part of the medical product. It
must be kept in an easily accessible place by the operator for all users, and remains part of the
product even when the product is sold on.
We reserve the express right to make changes to specifications shown in this instruction manual
that result from technical enhancements.
Reprints, translations and duplications in any form, in whole or in part, require consent in writing
from the publisher. Copyright lies with the publisher.
This instruction manual is not subjected to change management. Please contact the product
manufacturer for the current revision.
1 SOM 62/32/22 LED EN 2017-03

2 Symbols used and what they mean

Important visual instructions are on the device packaging, in the instruction manual and on the device. The
symbols used have the following meanings:
Symbol Explanation
By affixing the CE mark, the manufacturer certifies conformance of the

medical device to the fundamental requirements (Article 3) laid down in
Directive 93/42/EEC for medical devices
Shows the manufacturer of the medical device to EU Directive 93/42/EEC
Shows the serial number of a device so that a particular medical device can be
identified
Shows the date on which the medical device was manufactured
Follow the instruction manual. Failure to follow the instruction manual can
result in injury or material damage.
Caution
The warning triangle makes reference to potential sources of danger for people, to
injury risks or to health risks
General instruction sign. Denotes mandatory action by the user.
General prohibition sign. Denotes prohibited action by the user.
Shows a medical device that should not be used if the packaging is damaged
or open
Denotes a medical device that can break or be damaged if not handled with
due care
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Symbol Explanation
Denotes the upper and lower temperature values to which the medical device
can be exposed safely
Denotes the moisture range to which the medical device can be exposed
safely
Denotes a medical device that must be protected from moisture
Denotes the necessity for the user to refer to the instruction manual for
important information pertaining to safety (such as warning signs and
precautionary measures) that cannot be affixed to the medical device itself
for a number of reasons
The product entered into circulation after 13 August 2005 and may only be
disposed of in a separated waste stream (i.e. not in household waste)
Specifies a handling instruction, failure to comply with which does not

result in injury or material damage
CAUTION Denotes a danger that can cause minor injury or material damage
Denotes a danger that can cause semi-serious injury or material

WARNING damage
3 SOM 62/32/22 LED EN 2017-03

3 Warning and safety advice

Follow the instructions in this operating manual for proper function and safety of the device.
Do not use the device when faults occur.
3.1 Installation instructions
WARNING
The mains plug of the device is used
to isolate the device from the mains
power supply. Set up the device The ventilation for the device may not
such that the mains plug can be be obstructed.
accessed without obstruction at all
times.
Caution. To prevent the risk of
electrical shock, this device may To prevent damaging the device, do
only be connected to a supply not drop it or parts of it, or expose
having a protective earth it/them to other mechanical forces.
connector.
Only use approved components.
Unapproved components can have If the power lead is defective,
a bearing on the load-carrying immediately disconnect the device
capacity and stability of the device, from the mains supply and contact
and can cause damage to the the manufacturer.
device.
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3.2 Notes for use and disposal
WARNING
Whilst the device is being used,
The microscope may only be
ensure the patient does not look into
deployed for its intended use (as
the illumination unit of the
specified in these instructions).
microscope.
Maintenance and repairs may only be
Penetration of liquids into system
carried out when required by
components must be reliably
authorised specialists or by factory
prevented.
customer service.
Only spare parts and accessory When a fault occurs (such as when a
components approved by the fan is defective or ventilation slits are
manufacturer may be used. Please covered), immediately switch off the
contact the manufacturer in the device so as not to cause any damage
event of doubt. to it.
Only replace defective fuses with
Whilst the device is in use, all fuse
those having the same ratings
components must be correctly
(nominal voltage, nominal current
inserted as described in this manual.
and switch-off characteristics).
Use of the microscope is only Unplug the mains connector before

permitted in dry rooms. changing fuses.
Ensure that the device is only run on Do not use the device near sources of
voltages specified on the nameplate. electromagnetic radiation.
The device is fitted with a high-

Modifications to the device are strictly
performance light source. Ensure that
forbidden without consent from the
neither user nor patient is blinded by
manufacturer.
the light.
The residual risk of a hazard is assessed as extremely low if all instructions are followed and the
device is used as intended.
5 SOM 62/32/22 LED EN 2017-03

4 Directives, laws and standards

The medical device described here conforms to the fundamental requirements laid down in
Directive 93/42/EEC for medical devices. A conformity assessment procedure to Appendix VII has
been conducted successfully. The following harmonised standards were applied for the conformity
assessment procedure:
 EN 60601-1:2005 (ed.3)
 EN 60601-1-2:2007 (ed.3)
 EN 60601-1-6:2007
 EN ISO 14971:2009-10
 EN ISO 13485:2010-01
 DIN EN 980: 2008-08
 ISO 11884-1-2006
 EN ISO 9001:2008
 DIN EN 62471:2009-03
 Directive 93/42/EEC
5 Delivery state
5.1 Deliverables
The product is delivered as described below (depending on device model).
5.1.1 Deliverables for SOM 62 LED

The device is delivered as four individual sub-assemblies:
 Wheeled stand with four rollers

 Column
 Swivel and floating arms with electrical supply and lighting
 Microscope head including attachment
 Instruction manual
Fasteners for all components are included.

The device is delivered as three individual sub-assemblies:
 Ceiling bracket
 Operating instructions
SOM 62/32/22 LED EN 2017-03 6

The device is delivered as three individual sub-assemblies:
 Wall bracket
 Operating instructions
5.2 Transportation/packaging/unpacking/checking
The device is delivered as separate assemblies as described above, and installed and tested for
correct function by the specialist retailer or support personnel.
Check the packaging for damage before unpacking the device. If the packaging is
damaged, the contents may be as well. If the packaging is visibly damaged, please notify
the carrier immediately.
5.2.1 Unpacking
All packaging and filler material must be disposed of in line with applicable local regulations.
After unpacking all of the components, use the delivery note to check the delivery is
complete. If it is not, notify the supplier immediately.
6 Intended use
The product is intended for general-purpose operative and diagnostic medical deployment. It is
used for optimum illumination and magnification of the treatment area. The product may only be
used by trained specialists for the medical application described in this instruction manual.
Training is held by the manufacturer or by personnel authorised by the manufacturer. Intended
use does not include contact with the patient. The device may only be used in interior rooms
having sufficient levels of illumination and cleanliness.
7 SOM 62/32/22 LED EN 2017-03

7 Installation
The device may only be installed by personnel assigned by the manufacturer, or by the
manufacturer itself. Only the fixing and installation materials supplied may be used.
7.1 Installation of SOM62

7.1.1 Installation of wheeled stand and column
Carry out the following installation steps as in Figure 1:
 The four rollers (2) are already screwed to the foot (1). The rollers are fitted with brakes.
Engage/disengage the brakes on the rollers when moving and securing the device.
 Place the column (3) onto the flange of the foot and tighten it with four screws (5), using the
tool provided
 Hang the eight lead weights (6) into the bars of the foot
 Put on the protective cover (4)
 Secure the cover using the clamp ring (8) and four screws (7). Use the tool provided.
Be careful with the lead weights. Ensure not to drop them and protect
CAUTION hands, etc. from falling weights.
Figure 1
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7.1.2 Installation of swivel arm, suspension arm and microscope
 Undo the lock screw (3) on the upright guide cylinder (1) of the column (2)
 Put on the swivel arm (5). Ensure in the process that the star knob (4) is undone.
 Screw the lock screw (3) back on
 Undo the safety cap (6) from the guide cylinder (7) of the microscope carrier (8)
 Press in the lock pin (10) and push in all the way the guide cylinder of the microscope carrier.
The star knob (9) must be undone for this. Release the lock pin - it engages into place and
prevents the microscope head (11) from falling out.
 Hand-tighten the lock cap (6) onto the projecting threaded part of the guide cylinder
Always ensure that the lock screw (3) for securing the swivel arm, and
CAUTION the lock screw (6) for securing the microscope head, are mounted
correctly.
Figure 2
9 SOM 62/32/22 LED EN 2017-03

7.2 Installation of SOM 32
7.2.1 Installation of the ceiling bracket
 Using the aligner (1), drill four holes into the ceiling (Ø 10mm, hole depth 80mm)
 Clean the holes and check the distance between the holes using the aligner (1)
 Hammer in four through anchors (2) up to the mark and secure them to the torque specified
(45 Nm)
 Secure the aligner (1) to the ceiling using four screws (3) and four nuts (4)
 Before fitting the ceiling column to the aligner, place the mains cable (15) (on the connector
side) into the groove and ensure the mains cable is not pinched
 Unscrew the socket plate (6) from the column. Pull the cable down by about 150mm.
 Screw four threaded bolts (7) into the aligner (1) and secure them with lock ring (8) and nut
(9). Screw another four nuts (9) onto the threaded bolts (7). Put the washers (11) onto the
threaded bolts.
 Insert the column with flange (10) into the four threaded bolts (7) of the aligner, and secure
with four lock rings (8), four washers (11) and four nuts (9). Then align the column to be
perfectly vertical.
 Put on the cover (12), guide the mains plug out of the ceiling bracket and attach it with ring
(13) and three threaded pins (14)
 Carefully guide the cable (15) into the column, and insert and tighten the socket plate (6)
Figure 3
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 Undo the lock screw (2) on the upright guide cylinder (4) of the column (6)
 Put on the swivel arm (1). Ensure in the process that the star knob (5) is undone.
 Re-tighten the lock screw (2)
 Screw the threaded pin (3) all the way into the threaded hole of the lock screw, and
tighten it
 Carry out the remaining steps as in 7.1.2
Figure 4
Ensure at all times that the lock screw (2) is screwed in all the way
and that the threaded pin (3) is tightened. It must not be possible
WARNING for the lock screw (2) to become loose. Only the fixing and
installation materials supplied may be used.
11 SOM 62/32/22 LED EN 2017-03

7.2.3 Connecting up to the voltage supply
 Plug the connector (1) into the socket (5), noting the orientation of the connector
 Tighten the sleeve ring (2)
 Ensure that the spiral cable (4) does not turn excessively when the swivel arm (3) is rotated
Figure 5
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7.3 Installation of SOM 22
7.3.1 Fitting of the wall bracket
 Use the drill template (1) to drill four holes into the relevant wall.
The lower edge of the drill template must be about 1.65m above the floor.
 Remove the drill template
 Insert metal wall plugs (2). The front edges of the metal wall plugs must be flush with the
wall surface.
 If the drill bit deviates, drill the holes to be bigger and cement in the metal plugs (2). Check
the plug distances with the drill template (1).
Allow the cement to harden.
 Align the wall bracket (3) before securing it, and then secure it using four screws (4) and four
washers (5). Tighten the screws.
Figure 6
Only affix the device to walls capable of bearing the weight. Only
WARNING the fixing and installation materials supplied may be used.
13 SOM 62/32/22 LED EN 2017-03

Proceed with the steps in Section 7.1.2
8 Device description
8.1 Identification and nameplates
The nameplate is used for accurate identification of your product. It may not be removed or
modified. Figure 8 shows the position of the nameplate. It is located on the flat side of the swivel
arm (1), regardless of device variant.
Figure 7
Figure 8
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8.2 Controls
8.2.1 Controls
The device (SOM 62 only) is positioned on the floor with the wheeled stand. The foot has four
rollers for moving the device. The following locking mechanisms, securing elements and controls
are also fitted on the device (the same applies for SOM 22/32).
 Star knob (1) for determining the swivel arm position

 Main switch (14)
 Potentiometer (10) for regulation of lighting
 Star knob (3) for determining the height movement for the suspension arm
 Star knob (5) for rotation protection of the microscope head
 Knurled screw (8) for exchanging the binocular lens tube
 Knob (12) for adjusting the magnification changer
 Locking pin (4) to protect the microscope head from falling out during installation
 Star knob (2) for determining the rotation movement for the suspension arm
 Nameplate (13)
 Clamp lever (9) for adjusting the required friction to tilt the microscope head
 Lever (15) for swivelling in/out the colour filter (if available)
Figure 9
The nameplate (13) must be legible at all times. If the nameplate is not legible, or is
missing, a replacement must be sought.
15 SOM 62/32/22 LED EN 2017-03

8.3 Medical performance data
The medical performance data pertains to the required medical performance data of the medical
device. This performance data is listed in Section 16 "Technical description".
8.4 Additional loads

The load capacity and tipping stability of the systems are aligned to the components in our
product range. Only approved components may be installed and used.
8.5 Suspension arm adjustments

The weight adjustment of the suspension arm is set at the factory to the requirement on delivery.
The suspension arm adjustment may have to be aligned when components are used on or
removed from the device head. (Anti)clockwise adjustment of the Allen screw (1) is used for this.
Figure 10
SOM 62/32/22 LED EN 2017-03 16

9 Preparation
9.1 Power supply
Use the power lead to connect the device to the local voltage supply.
9.2 Brakes
The clamps are adjusted by tightening/loosening the star-knob screws (see Section 8.2). The
device clamps must be adjusted so that the degree of free movement satisfies the respective
requirements.
Never fasten the brake of the suspension arm (3 in Fig. 9) when the
CAUTION suspension arm has no load.
Never move the suspension arm when its brakes are activated.
9.3 Adjusting eye distance

The eye distance must be set individually for every user.
To do this, move the microscope to the working position and view an object through the
eyepieces. The eyepieces must be set to Index 0. The object must now be brought into focus by
adjusting the working distance. The distance of the eyepieces is now set in line with the lens tube
used by turning the knob (1). It must be possible for both eyes to make out the object by the same
amount, i.e. the object should be seen as a single 3-dimensional image.
Figure 11
17 SOM 62/32/22 LED EN 2017-03

9.4 Focusing
For dioptre adjustment, first undo the clamping screw (4) on the eyepieces (6). Then line up the
"Zero" on the dioptre scale (8) of the eyepieces (6) with the index mark (7) and move the
microscope towards the object until it appears in focus.
Those wearing glasses and with spherical ametropia for long distances can set the relevant dioptre
number on the eyepieces without glasses, and are able to focus as described above.
Ametropes with astigmatic eye failures keep on their glasses for distances, peel back the rubber
eye cups (5) of the eyepieces (9) and adjust the dioptre ring of the eyepieces to "Zero". Focusing is
then also as described above.
The clamping screw (4) must be re-tightened after the dioptre adjustment.
Figure 12
9.5 Checklist
Working through the following checklist prior to every use is a requirement to ensure safe use for
patient and user.
Function OK
Is the device connected to a suitable voltage source?
Are all parts and accessory parts installed correctly and fully
operational?
Are all cover caps removed?
Are illumination and brightness control working correctly?
Is the zoom/magnification unit working correctly?
All outer parts of the microscope are cleaned and free of dirt
and impurities.
A check must be made in the operation area on whether the
sterilisation hood is being used properly.
SOM 62/32/22 LED EN 2017-03 18

10 Operation
10.1 Transport position / rest position (SOM62 LED only)
The device must be moved into a transport position for safe transportation. For this, the clamps of
the axes must be undone and the device moved into the transport position shown in Figure 13.
The device is at risk of tipping over if not moved

WARNING into the transport position described.
Figure 13
19 SOM 62/32/22 LED EN 2017-03

10.2 Replacing objective and eyepieces
The following steps are required to replace lenses and eyepieces (refer to Figure 14):
 The objective (1) has a screwed socket. Turn to the left to release the objective and to the
right to affix it. Only hand-tighten them.
 The eyepieces (2) are inserted. To remove them, they are simply pulled out, and the
replacements are inserted.
Figure 14
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10.3 Switching the device on and off
The main switch (1) of the device is located on the flat side of the swivel arm. The device is ready
to use when the green status light (2) is ON.
The red status light indicates overheating of the electronics.
If the red status light (3) is ON, immediately switch off the device and check the ventilation slits. If
they are dirty, try to remove the dirt with a brush or slightly moist cloth. Then switch the device
back on. If the red status light is still ON, immediately switch off the device and call customer
service.
Figure 15
Do not use the device when the red status light is ON as it can result
CAUTION in damage to the electronics.
21 SOM 62/32/22 LED EN 2017-03

10.4 Brightness control
Turning the potentiometer (1) enables continuously variable adjustment of the LED brightness to
the requirements of the user.
Figure 16
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10.5 Magnification adjustment
10.5.1 Magnification setting on the changer
Magnification is used to make the finest of structures visible. 3-level (0.63, 1, 1.6) or 5-level (0.4,
0.63, 1, 1.6, 2.5) magnification can be selected depending on model. Turn the knob (1) to set the
magnification required. Engaging of the knob at the marking indicates that the magnification has
been set correctly.
Figure 17
10.5.2 Magnification setting on the zoom unit

For continuously variable adjustment of the magnification on the zoom unit, turn the knob (1)
until the required magnification is reached. The scale ring (2) shows the current magnification
factor of the zoom unit.
Figure 18
23 SOM 62/32/22 LED EN 2017-03

10.6 Swivelling in/out the filter
The device can be fitted with a colour filter as an option. Move the lever (1) to swivel in the colour
filter.
Figure 19
10.7 Removing/exchanging the binocular tube

 Undo the knurled screw (1) and remove the tube (2)
Figure 20
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11 Shutting the system down
After every treatment, the device must be cleaned and disinfected depending on application and
in accordance with the specifications in 12 Cleaning and maintenance. The device must then be
moved into the transport position described in 10.1 Transport position / idle position. This is the
optimal idle position when the device is not in use. If the device is not used for longer than 24
hours, putting on the lens covers (supplied) and pulling the protective cover (supplied) over the
device are recommended. Similarly, unused accessories should be removed and placed into the
storage packaging provided. This prevents damage to the lenses and dirtying of the device.
12 Cleaning and maintenance

12.1 Fuse replacement
Carry out the following steps as in Figure 21:
 Unplug the mains connector. Insert a screwdriver into the slit of the fuse holder (1) and turn it
anticlockwise by 90°. A spring presses the cap up.
 Remove the cap and replace the fuse attached in the cap
 Insert the cap with a new fuse in, press it down and lock it into place by turning the
screwdriver clockwise by 90°
Figure 21
Only replace defective fuses with those having the same ratings
CAUTION (nominal voltage, nominal current and switch-off characteristics).
25 SOM 62/32/22 LED EN 2017-03

12.2 Disinfection and sterilisation
Moisten a cloth with antiseptic liquid (such as Sagrotan – P). Wipe as required the parts of the
microscope touched most often (such as knobs and hand grips).
For some controls, sterilizable covers are available. We recommend replacing these after 30
sterilization cycles with new ones. The sterilization may be carried out with an autoclave at a
temperature of 134 ° C and a pressure of 2 bar.
12.3 Cleaning optical surfaces

Remove coarse dirt particles from outer optical surfaces with a clean, dry hair brush (lens,
eyepiece, eyepiece lens). Beforehand, clean the brush in pure alcohol or ether, and allow it to dry.
Then moisture a soft cotton cloth with pure alcohol and wipe the lens with a circular motion from
the centre of the lens outwards. Breathe on the lens and re-polish it with a dry cotton cloth
(cleaning kits suitable for glasses can also be used).
The anti-reflex coats are extremely resistant because they have been hot coated. The coats are not
damaged if cleaning is as described above.
12.4 Cleaning painted parts

Moisten a soft cotton cloth with water (to which just a little washing-up liquid has been added)
and wipe it over the dirty parts. For any remaining spots, moisten the cloth with pure alcohol or
cleaning solvent and wipe the spots carefully.
12.5 Maintenance
The device need not be serviced at regular intervals. The recommendation nevertheless,
depending on frequency of use, is to have an inspection carried out by a service centre authorised
by the manufacturer. Contact the manufacturer for information on these service centres.
12.6 Replacing LEDs

The stand-out feature of LEDs is their very long service life. Should faults occur with the LED
lighting unit however, maintenance may only be carried out by authorised specialists or the
factory customer service team.
12.7 Replacing the power lead

The power lead may only be replaced by the manufacturer or a person authorised by the
manufacturer.
13 Disposal
User information on disposing electrical equipment:
This symbol denotes products that may not be disposed of in
household waste. Proper disposal is to the benefit of us and the
environment.
For more detailed information on disposal, please contact the local
sales outlet or the manufacturer.
Disposal within the European Union

Please contact the local sales outlet or the manufacturer specified.
Disposal outside the European Union
Please enquire into which disposal regulations are applicable in your
SOM 62/32/22 LED EN 2017-03 26

country.
14 Accessories
The system is a medical product and has been developed and tested in accordance with applicable
standards. Do not use any accessory parts that are not approved for the device or do not satisfy
the applicable standards/directives. Please contact the manufacturer in the event of doubt.
27 SOM 62/32/22 LED EN 2017-03

15 When faults occur
The device works extremely reliably when used as intended. Should faults occur nevertheless,
please follow the instructions in Section 15.1.
15.1 Summary of potential faults

Fault Cause Fault Rectification
No microscope lighting Mains switch in OFF position Move the switch to "ON"
Mains switch of lighting unit Move the switch to "ON"
in OFF position
Mains cable not connected to Plug in the cable
socket
LED defective Send in the lighting unit
No voltage supply to the Set the contacts correctly via the plug
lighting unit connectors
In-house power supply outage Have the electrical installation checked
System cannot be positioned with One of more brakes applied Disengage the brake
the foot rollers or can only be
moved with high level of exertion
Rollers dirty Clean the rollers
Roller defective Have the roller replaced by Service
Floating arm can only be tilted with Brake too tight Loosen the brake from the star knob
difficulty, or not at all
Floating arm drops slowly Pressure spring defective Have the floating arm corrected by
Service
Load too high Align the pre-tension or replace the
spring arm
Swivel arm can only be moved with Brake too tight Loosen the brake from the star knob
difficulty, or not at all
Microscope head can only be moved Brake too tight Loosen the brake from the star knob
with difficulty, or not at all
Only one optical channel visible View not set correctly to the
Adjust the view (eye distance)
through the lens tube eye distance
Use the knob to set the changer to the
Changer to intermediate
Vignetting visible in image magnification required until the
position
position engages noticeably
Adjust the dioptre as per the
Uneven focus in right and left views Incorrect dioptre setting
instructions
Image foggy Eyepieces or lens dirty Clean the lens as per the instructions
Eyepieces, lens or light guide
Dirt in image Clean the lens as per the instructions
dirty
Switch the device off. Clean the
ventilation openings of the lighting
Sudden drop in light power The lighting is overheated unit with a slightly moist cloth. Notify
the manufacturer if the fault still
occurs.
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16 Technical description
16.1 Technical details
Model SOM62 LED, SOM 32 LED, SOM22 LED
Dimensions and weight
Dimensions of SOM 62/SOM 32/SOM 22 See Figure 22/23/24
Weight of SOM 62/SOM 32/SOM 22 Approx. 120 kg / approx. 45 kg / approx. 35 kg
Function data
Function displays Status display on ON/OFF switch
Supply connectors Mains connector, 1-phase AC
Isolation Power lead
Operation All controls are mechanical. Refer to the
description for the mode of operation.
Operational information
Place of use Enclosed rooms, not in oxygen-rich
environments
Protective class I, protective earth conductor
Equipment protection IP 20
Duty type Long-term usage
Electrical safety DIN EN ISO 60601-1:2005
Mains voltage 115 / 230 V AC
Mains frequency 50 / 60 Hz
Illumination type LED
Enviromental conditions
Operational ambient temperature +10°C to +35°C
Operational ambient humidity 30% to 85%
Air pressure 800 hPa to 1060 hPa
Storage ambient temperature -20°C to +70°C
Storage ambient humidity Maximum 100%
Regulatory information
Classification to 93/42 EEC I (Appendix IX Rule 1)
Protection class 1
Standards applied  EN 60601-1:2005 (ed.3)
 EN 60601-1-2:2007 (ed.3)
 EN 60601-1-6:2007
 EN ISO 14971:2009-10
 EN ISO 13485:2010-01
 DIN EN 980: 2008-08
 ISO 11884-1-2006
 EN ISO 9001:2008
 DIN EN 62471:2009-03
 Directive 93/42/EEC
Manufacturer Karl Kaps GmbH & Co. KG / Asslar
CE mark
29 SOM 62/32/22 LED EN 2017-03

16.2 Dimensions
16.2.1 SOM 62 LED
Figure 22
SOM 62/32/22 LED EN 2017-03 30

16.2.2 SOM 32 LED
Figure 23
16.2.3 SOM 22 LED
Figure 24
31 SOM 62/32/22 LED EN 2017-03

17 Declaration of conformity
EG Konformitätserklärung
(Richtlinie 93/42/EWG)
EC Declaration of Conformity
(Directive 93/42/EEC)
Hersteller/manufacturer: Karl Kaps GmbH & Co.
Anschrift/address: Schulstrasse 57
35614 Asslar/ Wetzlar
Germany
Produktbezeichnung/ Produktgruppe: Operations-/ Diagnostik-Mikroskop mit

LED-Beleuchtung
Operation-/ Diagnostic-microscope with
LED-illumination
Typen/types: SOM 62 LED; SOM 32 LED; SOM22 LED
Klasse/class: I
Wir erklären hiermit, dass das hier beschriebene Medizinprodukt mit den Forderungen der
Richtlinie 93/42/EWG, Anhang I übereinstimmt. Der Nachweis hierzu wurde mit dem
Konformitätsbewertungsverfahren nach Anhang VII geführt.
We declare that the above listed medical product conforms to the relevant provisions of
the actual EC Council Directive 93/42/EEC Annex I. The conformity assessment procedure
was carried out according to Annex VII.
Referenz- Nr./reference no.:

EN 60601-1:2005 (ed.3)
EN 60601-1-2:2007 (ed.3)
EN 60601-1-6:2007
EN ISO 14971:2009-10
EN ISO 13485:2010-01
DIN EN 980: 2008-08
ISO 11884-1-2006
DIN EN 62471:2009-03
EN ISO 9001:2008
Richtlinie 93/42/EWG
Aussteller/issued by: Karl Kaps GmbH & Co.
Ort, Datum/place, date: Asslar, 20.05.2014
Rechtsverbindliche Unterschrift:
SOM 62/32/22 LED EN 2017-03 32

18 Warranties
We provide a warranty for the respective period stipulated legally from the time of transfer of the
product to the purchaser. Complaints due to incomplete or incorrect delivery, and objections due
to evident deficiencies, must be communicated immediately after receipt of the delivery, and
immediately after their discovery in writing in the event of other deficiencies.
The purchaser must preserve right of recourse against third parties (such as for a factual report in
the event of damage during transit). Processing or further sale, or combination or mixing, shall be
deemed to constitute unconditional approval. In the event of notice of defects being submitted in
due time, we shall accept liability within the framework of the provisions set out hereinafter. Our
liability due to deficiencies (warranty) extends to providing products free of defects to the degree
possible in accordance with best available technology. Modifications to design or implementation
carried out by us prior to delivery do not provide entitlement to complaint or objection.
In the event we have warranty claims against our suppliers, our liability is fulfilled through
assignment of these claims to the purchaser who already agrees to accept this assignment for this
case.
If a claim cannot be asserted against the supplier or if the supplier refuses to accept any liability in
respect of the purchaser, our liability shall be limited to supplementary performance, i.e. delivery
of a substitute or repair at our discretion. The purchaser must release the defective goods or parts
replaced to us.
If supplementary performance fails or we are not in a position to deliver, the purchaser is entitled
to withdraw from the contract or lower the purchase price. All liability restrictions are not
applicable to consumer goods or batteries, or improper use or installation of the device.
Any entitlement of the purchaser to reimbursement of costs incurred in conjunction with the
assertion of claims against a supplier shall in all cases be excluded if any actions triggering the
costs, specifically the initiation of legal proceedings, were not agreed with us beforehand.
All warranty claims must be directed to the organisation that sold you the device. In special cases,
please contact:
Karl Kaps GmbH & Co. KG

Schulstrasse 57
35614 Asslar, Germany
33 SOM 62/32/22 LED EN 2017-03

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SOM 62/32/22

Karl Kaps GmbH & Co KG

SOM 62/32/22 LED EN 2017-03

SOM 62/32/22 LED DE 2017-03

1 SOM 62/32/22 LED EN 2017-03

2 Symbols used and what they mean

By affixing the CE mark, the manufacturer certifies conformance of the

Shows the manufacturer of the medical device to EU Directive 93/42/EEC

Shows the date on which the medical device was manufactured

General instruction sign. Denotes mandatory action by the user.

General prohibition sign. Denotes prohibited action by the user.

SOM 62/32/22 LED EN 2017-03 2

Denotes a medical device that must be protected from moisture

Specifies a handling instruction, failure to comply with which does not

Denotes a danger that can cause semi-serious injury or material

3 SOM 62/32/22 LED EN 2017-03

3 Warning and safety advice

3.1 Installation instructions

SOM 62/32/22 LED EN 2017-03 4

Use of the microscope is only Unplug the mains connector before

The device is fitted with a high-

5 SOM 62/32/22 LED EN 2017-03

4 Directives, laws and standards

5.1.1 Deliverables for SOM 62 LED

 Wheeled stand with four rollers

Fasteners for all components are included.

5.1.2 Deliverables for SOM 32 LED

Fasteners for all components are included.

SOM 62/32/22 LED EN 2017-03 6

Fasteners for all components are included.

7 SOM 62/32/22 LED EN 2017-03

7.1 Installation of SOM62

SOM 62/32/22 LED EN 2017-03 8

9 SOM 62/32/22 LED EN 2017-03

SOM 62/32/22 LED EN 2017-03 10

11 SOM 62/32/22 LED EN 2017-03

SOM 62/32/22 LED EN 2017-03 12

13 SOM 62/32/22 LED EN 2017-03

SOM 62/32/22 LED EN 2017-03 14

 Star knob (1) for determining the swivel arm position

15 SOM 62/32/22 LED EN 2017-03

8.4 Additional loads

8.5 Suspension arm adjustments

SOM 62/32/22 LED EN 2017-03 16

9.3 Adjusting eye distance

17 SOM 62/32/22 LED EN 2017-03

SOM 62/32/22 LED EN 2017-03 18

The device is at risk of tipping over if not moved

19 SOM 62/32/22 LED EN 2017-03

SOM 62/32/22 LED EN 2017-03 20

21 SOM 62/32/22 LED EN 2017-03

SOM 62/32/22 LED EN 2017-03 22

10.5.2 Magnification setting on the zoom unit

23 SOM 62/32/22 LED EN 2017-03

10.7 Removing/exchanging the binocular tube

SOM 62/32/22 LED EN 2017-03 24

12 Cleaning and maintenance

25 SOM 62/32/22 LED EN 2017-03

12.3 Cleaning optical surfaces