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KARL KAPS SOM 22 LED, Instructions For Use Manual

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KARL KAPS SOM 22 LED Instructions For Use Manual Download Page 32

Instructions for use SOM 62/32/22 LED  

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

 

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 

 

 

Summary of Contents for SOM 22 LED

Page 1: ...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 Germany Fax 49 0 6441 85 9 85 www kaps optik de ...

Page 2: ...ing bracket 10 7 2 2 Installation of swivel arm suspension arm and microscope 11 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 7 3 2 Installation of swivel arm suspension arm and microscope 14 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...

Page 3: ...isation 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 c...

Page 4: ...bles 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 resul...

Page 5: ... 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...

Page 6: ...tion 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 resu...

Page 7: ...ccessed without obstruction at all times The ventilation for the device may not be obstructed Caution To prevent the risk of electrical shock this device may only be connected to a supply having a protective earth connector To prevent damaging the device do not drop it or parts of it or expose it them to other mechanical forces Only use approved components Unapproved components can have a bearing ...

Page 8: ... may be used Please contact the manufacturer in the event of doubt When a fault occurs such as when a fan is defective or ventilation slits are covered immediately switch off the device so as not to cause any damage to it Only replace defective fuses with those having the same ratings nominal voltage nominal current and switch off characteristics Whilst the device is in use all fuse components mus...

Page 9: ... 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 I...

Page 10: ...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 di...

Page 11: ...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 ...

Page 12: ... 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...

Page 13: ... 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...

Page 14: ...vel 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 WARNING 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 for the lock screw 2 to ...

Page 15: ...N 2017 03 12 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 ...

Page 16: ...rill 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 screw...

Page 17: ...oceed 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 ...

Page 18: ...ob 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 ...

Page 19: ...al 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 devic...

Page 20: ...g 9 when the 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 dis...

Page 21: ... 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...

Page 22: ...tion 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 WARNING The device is at risk of tipping over if not moved into the transport position described Figure 13 ...

Page 23: ...ing 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 ...

Page 24: ...ght 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 CAUTION Do not use the device when the red...

Page 25: ... for use SOM 62 32 22 LED SOM 62 32 22 LED EN 2017 03 22 10 4 Brightness control Turning the potentiometer 1 enables continuously variable adjustment of the LED brightness to the requirements of the user Figure 16 ...

Page 26: ...ification 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...

Page 27: ...017 03 24 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 ...

Page 28: ...r 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 12Cleaning 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 anticlockwi...

Page 29: ...o 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 ...

Page 30: ...ories 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 ...

Page 31: ...o tight Loosen the brake from the star knob 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 difficulty or not at all Brake too tight Loosen the brake from the star knob Microscope head can only be moved with difficulty or not at all Brake too tight Loosen t...

Page 32: ...ronments 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 ...

Page 33: ...Instructions for use SOM 62 32 22 LED SOM 62 32 22 LED EN 2017 03 30 16 2 Dimensions 16 2 1 SOM 62 LED Figure 22 ...

Page 34: ...Instructions for use SOM 62 32 22 LED 31 SOM 62 32 22 LED EN 2017 03 16 2 2 SOM 32 LED Figure 23 16 2 3 SOM 22 LED Figure 24 ...

Page 35: ...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 R...

Page 36: ...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 s...

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