Related Manuals for KLS Martin group marLED V10
Summary of Contents for KLS Martin group marLED V10
- Page 1 ® Operating Lights marLED V10/V16 Instructions for Use V. 1.3 (2014-01) Valid from release SW 14 90-743-52-13 and release HW 21...
- Page 2 Symbol explanation Safety alert symbol CAUTION Indicates a situation which, if not avoided, could result in minor or moderate injury. WARNING Indicates a situation which, if not avoided, could result in death or serious injury. DANGER Indicates a situation which, if not avoided, will result in death or serious injury.
- Page 3 Instructions for Use ® Operating Lights marLED V10/V16 Stacking height max. 2 layers, max. load 250 kg per item Manufacturer CE mark of conformity Warning: Dangerous high voltage! This product may not be disposed of as normal household garbage, see section 16.3 “Disposal of the Device”, page 42. V.
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Page 4: Table Of Contents
Instructions for Use ® Operating Lights marLED V10/V16 Contents Terms & Acronyms .................. 6 Product Liability and Warranty ............7 General Information ................7 Intended Use ..................7 Warranty ..................... 9 User’s Inspection .................. 9 Hotline....................10 Notices Concerning this Document..........10 Validity of this Document .............. - Page 5 Instructions for Use ® Operating Lights marLED V10/V16 Replacing Components ..............24 Replacing the Sterilizable Handle ............24 Handle for Sterile Disposable Covers (Optional) ........25 7.2.1 Replacing the Sterile Disposable Cover .............. 25 Replacing Light Sources ............... 25 Accessories................26 Cleaning and Disinfecting the Light ..........
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Page 6: Terms & Acronyms
Instructions for Use ® Operating Lights marLED V10/V16 Terms & Acronyms Designation Description ASPS Additional safety power supply (battery) backLite Brightness regulation 2 % for endoscopic background illumination Cardanic system Light head suspension up to spring arm, with one or more cardan joints Fully cardanic Cardanic system with 2 cardan joints, rotatable in 3 axes Low-ceiling cardanic suspension: simplified cardanic system with one cardan... -
Page 7: Product Liability And Warranty
We are the manufacturer of this product: Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · D-78532 Tuttlingen · Germany Postfach 60 · D-78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax +49 7461 706-193 info@klsmartin.com ·... - Page 8 Instructions for Use ® Operating Lights marLED V10/V16 NOTICE Risk of interference and malfunction As a medical electrical device, the operating light is subject to special precautions • regarding electromagnetic compatibility (EMC). It is mandatory to install and operate the device in accordance with the EMC Guidelines provided herein, see section 15 “Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC)”, page 38.
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Page 9: Warranty
Instructions for Use ® Operating Lights marLED V10/V16 Warranty Our Standard Terms and Conditions of Sale effective at the time shall apply. Agreements di- verging from these Standard Terms and Conditions do not restrict the legal rights of the buyer. Any warranty exceeding the above provisions shall require a contractual form and shall exclude component-related vandalism, software updates and consumables. -
Page 10: Hotline
Instructions for Use ® Operating Lights marLED V10/V16 Hotline Should you have any questions on how to handle the product or use it for clinical • applications, please do not hesitate to contact the Product Management: Tel: +49 7461 706-109 Fax: +49 7461 706-190 Should you have any technical questions, please do not hesitate to turn to our... -
Page 11: Validity Of This Document
Instructions for Use ® Operating Lights marLED V10/V16 Validity of this Document This document is valid from software release SW 14 and hardware release HW 21. If used with older hardware releases, it may be that newer functions described in this document are not available. -
Page 12: Safety Notices
Instructions for Use ® Operating Lights marLED V10/V16 Safety Notices General Information The operating lights are quality products designed and manufactured in accordance with the recognized technical rules. The products leave the factory in a perfectly safe working condition. To maintain this status, you – as the end user – are required to abstain from or prevent any action that might have an adverse effect on the lights’... -
Page 13: Pilot Laser (Option)
Instructions for Use ® Operating Lights marLED V10/V16 Pilot Laser (Option) The built-in pilot laser is a Class 2 laser according to the German DIN/VDE 0837 standard (corresponds to EN 60825 and lEC 60825). These regulations, together with local accident prevention regulations (VBG 93 for Germany), must be duly observed when operating the laser. -
Page 14: Personal Protection
Instructions for Use ® Operating Lights marLED V10/V16 Personal Protection WARNING Danger of serious injury from defective lights! Defective lights can damage the health or even threaten the lives of users and/or patients! • Therefore, never operate defective lights! WARNING Danger of serious injury from excessive heat development! When using several lights in combination, the light fields should not overlap when using maximum illuminance and very small light field diameters. -
Page 15: Operation
Instructions for Use ® Operating Lights marLED V10/V16 Operation Prior to each use, be sure to check the lights for safe functioning and proper operating • condition! Be sure to handle the lights in accordance with the instructions provided in this user •... -
Page 16: Cleaning And Infection Protection
Instructions for Use ® Operating Lights marLED V10/V16 Cleaning and Infection Protection In addition to the following safety notices, observe the cleaning and disinfection • instructions provided in section 9 “Cleaning and Disinfecting the Light”, page 27. WARNING Danger of serious injury from electric shock! Prior to performing any cleaning or disinfecting work, be sure to deenergize the light system: Disconnect the light system all-pole from the power supply. -
Page 17: Light Models And Combination Options
Instructions for Use ® Operating Lights marLED V10/V16 Light Models and Combination Options Light Models The lights are available in the following variants: Size of light head: • ® — marLED V10 (max. illuminance of 130,000 lx): 64 x 46 cm ®... -
Page 18: Description Of The Lights
Instructions for Use ® Operating Lights marLED V10/V16 Description of the Lights LED Technology ® The marLED V10/V16 lights operate on the basis of LED illumination units (so-called “light engines”) of the latest technology. Compared with conventional halogen lamps, these “engines”... -
Page 19: Cameras Surgicam Digital, Surgicam
Instructions for Use ® Operating Lights marLED V10/V16 ® ® 5.3.2 Cameras SurgiCam digital, SurgiCam ® ® The SurgiCam digital and SurgiCam HD systems are imaging systems for documentation and/or training purposes. Each of these high-performance camera systems can either be integrated into the light head’s central handle or installed on an arm of its own. -
Page 20: Operating The Lights
Instructions for Use ® Operating Lights marLED V10/V16 Operating the Lights The lights can be operated in two different ways: non-sterile via the sensoTouch control panel, or sterile via the sensoGrip integrated into the handle. Mounting the Sterilizable Handle Prior to each operation, the light must be fitted with the sterilized handle (see section 7.1 “Replacing the Sterilizable Handle”, page 24). - Page 21 Instructions for Use ® Operating Lights marLED V10/V16 Fig. 6-1: sensoTouch control panel ON/OFF switch with green LED: ON: LED lit/OFF: LED goes out Press ON/OFF switch for at least 1 second. A red LED signals a malfunction. Color temperature 2 (5) The color temperature is preset to 4,300 K (standard value).
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Page 22: Using The Sterilizable Handle (Sensogrip) For Light Control
Instructions for Use ® Operating Lights marLED V10/V16 ® When using light models equipped with SurgiCam digital the buttons (3), (4), (9) and (10) ® are also used for additional functions such as zoom and image rotation (see SurgiCam user manual). -
Page 23: Using The Optional Wall Control Panel For Operation
Instructions for Use ® Operating Lights marLED V10/V16 Other switching functions can be implemented upon request as well, e.g. camera zoom, camera rotation, type of light field, color temperature, light field size or light ON/OFF. It is also possible to set the mode of handle operation, selecting from among the following options: •... -
Page 24: Replacing Components
Instructions for Use ® Operating Lights marLED V10/V16 Replacing Components Replacing the Sterilizable Handle WARNING Danger of serious injury from electric shock! Be aware that the lights remain connected to the power supply (mains) after they have been turned off with the control-panel power switch! •... -
Page 25: Handle For Sterile Disposable Covers (Optional)
Instructions for Use ® Operating Lights marLED V10/V16 Handle for Sterile Disposable Covers (Optional) This handle version is not available for central handles equipped with a camera. To install a handle support for sterile disposable covers in ® an existing handle unit, please refer to the marLED Mounting Instructions. -
Page 26: Accessories
Instructions for Use ® Operating Lights marLED V10/V16 Accessories Designation Sterilizable standard handle 89-930-00-04 Sterilizable handle for lights with pilot laser 89-930-02-04 Sterilizable handle for lights with camera 89-930-04-04 Handle for sterile covers 89-940-02-04 Handle for sterile covers for lights fitted with a camera mounting 89-940-05-04 preparation set Sterile covers for REF 89-940-02-04 and REF 89-940-05-04... -
Page 27: Cleaning And Disinfecting The Light
Instructions for Use ® Operating Lights marLED V10/V16 Cleaning and Disinfecting the Light General Information Proper care of the light system requires regular cleaning and disinfection using suitable cleaners and disinfectants. The responsibility for cleaning and disinfection lies with the operator/user of the product. Be sure to observe your local cleaning and hygiene regulations. -
Page 28: Cleaning The Light's Externally Accessible Parts
Instructions for Use ® Operating Lights marLED V10/V16 NOTICE Use qualified staff only! Cleaning and disinfection must be done by duly instructed cleaning personnel. Cleaning the Light’s Externally Accessible Parts NOTICE Risk of surface damage! To prevent damage, do not use scouring, alkaline, acidic or alcoholic cleaning agents •... -
Page 29: Manual Disinfection Of Externally Accessible Parts
Instructions for Use ® Operating Lights marLED V10/V16 Manual Disinfection of Externally Accessible Parts 9.3.1 Wipe Disinfection The “wipe disinfection” method is mandatory for Gebrüder Martin lights. How often wipe disinfection is required depends on the specifications of your hygiene plan. The frequency may vary from room to room. -
Page 30: Machine Disinfection And Sterilization Of The Handles
Instructions for Use ® Operating Lights marLED V10/V16 NOTICE Risk of surface damage! To prevent embrittlement of plastic parts, use only disinfectants with a low alcohol • content. Do not use highly alkaline solutions or strong acids. • As a rule, be sure to use disinfectants in a way that no liquid can penetrate into the light •... - Page 31 Instructions for Use ® Operating Lights marLED V10/V16 NOTICE Danger of handle damage! Machine disinfection can damage the product if performed incorrectly. Never use hot-air sterilization for processing, as this would destroy the handle material! Never use detergents/disinfectants containing the following substances because these substances may lead to changes in the material: Highly concentrated organic and inorganic acids •...
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Page 32: Maintenance
Instructions for Use ® Operating Lights marLED V10/V16 Maintenance NOTICE Use qualified personnel! All maintenance work must be carried out by a hospital technician (or comparably trained personnel). WARNING Risk of infection! To prevent infections during maintenance work, make sure that such work is carried out only on lights (and equipment) that have previously been cleaned and disinfected! 10.1 Regular Checks to Be Carried out by Owner/Operator... -
Page 33: Troubleshooting
Instructions for Use ® Operating Lights marLED V10/V16 Troubleshooting Symptom Potential Cause(s) Remedial Action Light cannot be turned on ON/OFF switch (4) not Operate ON/OFF switch (4) operated (OFF) (LED (3) remains off, display (1) remains dark) Main switch not operated Operate main switch Pilot laser not visible Sterilizable handle on... -
Page 34: Technical Data
Instructions for Use ® Operating Lights marLED V10/V16 Technical Data ® 12.1 Technical Data for marLED V10/V16 ® ® Designation marLED marLED PSU input voltage 100–240 VAC, 50–60 Hz PSU output voltage (28–36 VDC, adjustable) Supply voltage at contact block min. - Page 35 Instructions for Use ® Operating Lights marLED V10/V16 ® ® Designation marLED marLED Ambient conditions -10°C to +50°C (14°F to +122°F) at 20–90% humidity Storage temperature (non-condensing) +5°C to +40°C (41°F to +104°F) at 30–80% humidity Operating temperature (non-condensing) Air pressure 620–1,060 hPa Max.
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Page 36: Serial Number Structure
Instructions for Use ® Operating Lights marLED V10/V16 Serial Number Structure The serial number is indicated on the rating plate attached to the cardan joint on the rear side of the sensoTouch control panel. It is structured as follows: V16 C3B 1135 Consecutive number per year of manufacture* Installation type: C=ceiling, W=wall... -
Page 37: Safety Checks (Sc)
Instructions for Use ® Operating Lights marLED V10/V16 Safety Checks (SC) NOTICE Risk of property damage! If the light is not reliable or safe to operate, authorized service personnel must repair it! • If immediate repair is not possible, the light must be withdrawn from service and •... -
Page 38: Guidelines And Manufacturer's Declaration Regarding Electromagnetic Compatibility (Emc)
Instructions for Use ® Operating Lights marLED V10/V16 Guidelines and Manufacturer’s Declaration Regarding Electromagnetic Compatibility (EMC) Guidance and manufacturer’s declaration – Electromagnetic interference emission ® The marLED V10/V16 is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment. - Page 39 Instructions for Use ® Operating Lights marLED V10/V16 Guidance and manufacturer’s declaration – Electromagnetic immunity ® The marLED V10/V16 is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment. IEC 60601 Electromagnetic Immunity test...
- Page 40 Instructions for Use ® Operating Lights marLED V10/V16 Guidance and manufacturer’s declaration – Electromagnetic immunity ® The marLED V10/V16 is intended for use in an electromagnetic environment as specified below. The user should assure that it is used in such an environment. IEC 60601 Compliance Immunity test...
- Page 41 Instructions for Use ® Operating Lights marLED V10/V16 Recommended separation distances between portable and mobile ® RF telecommunications equipment and the Gebrüder Martin marLED V10/V16 ® The marLED V10/V16 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
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Page 42: Ecological Information
Instructions for Use ® Operating Lights marLED V10/V16 Ecological Information 16.1 Disposal of Packing Gebrüder Martin will, as a matter of course, take back the full packaging if so desired, to recycle as many parts of the packaging as possible. If you do not wish to make use of this offer, you can dispose of the packaging with the normal paper or domestic garbage. - Page 43 Instructions for Use ® Operating Lights marLED V10/V16 V. 1.3...
- Page 44 Tel. +971 4 454 1655 middleeast@klsmartin.com Gebrüder Martin GmbH & Co. KG A company of the KLS Martin Group KLS Martin Platz 1 · 78532 Tuttlingen · Germany Postfach 60 · 78501 Tuttlingen · Germany Tel. +49 7461 706-0 · Fax 706-193 info@klsmartin.com ·...
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