Related Manuals for MIMSAL MIMLED 600
Summary of Contents for MIMSAL MIMLED 600
- Page 1 INSTRUCTIONS FOR OPERATION AND INSTALLATION MIMLED 600 | MIMLED 1000 MINOR SURGICAL LIGHTS VERSIONS: TROLLEY STAND | CEILING SUPPORT | WALL SUPPORT...
- Page 2 Congratulations on the purchase of your new MIMLED 600 | MIMLED 1000 Minor surgical light from MIMSAL TRADE S.L. Our simple operating concept allows for intuitive handling using both the control panel on the housing and the detachable handle. The light weight design of the light head and choice of quality and support systems certified for the medical field with integrated power supply allows flexible use at your workplace.
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Page 3: Table Of Contents
TABLE OF CONTENTS 1. Safety Instructions 2. Brief Description 3. Operation 3.1 Check Before Each Use 3.2 Operation of the Lamp Head 3.2.1 Operation of Lamp Head 3.2.2 Quick Start via Sterilizable Handle 3.3 Working Areas of the Support Systems 3.3.1 Mobile Stand Model 3.3.2 Ceiling Mount Model 3.3.3 Wall Mount Model... - Page 4 10. Mounting of the Lamp Head 10.1 Lamp Head Assembly 10.2 Mobile Stand Assembly 10.2.1 Mount Rollers 10.2.2 Mount Stand Tube 10.2.3 Mount Safety Ring 10.2.4 Mount Extension Arm with Spring Arm 10.2.5 Adjust Spring Force 10.2.6 Replacing Fuses 11. Mounting the Wall Fixture and Ceiling Fixture 11.1 Choice of Fasteners 11.2 Wall Mounting 11.3 Mounting the Ceiling Fixture...
- Page 5 SYMBOLS SYMBOL MEANING INSTRUCTIONS DECLARATION OF CONFORMITY MEDICAL DEVICE ITEM CODE SERIAL NUMBER MANUFACTURING DATE NAME AND ADDRESS OF THE MANUFACTURER ELECTRONIC WASTE RECYCLING ELECTRICAL INSULATION CLASS Class I ELECTRICAL INSULATION CLASS Class II AMBIENT TEMPERATURE Shows the permitted ambient temperatures from -25 °C to 70 °C for transport and storage. AIR PRESSURE Shows the permitted air pressure values from 500 hPa to 1060 hPa for transport and storage.
- Page 6 ML1000W MIMLED 1000 WALL WALL ML1000FL MIMLED 1000 TROLLEY TROLLEY STAND MODEL SUPPORT ML600C 200 MIMLED 600 CEILING 200 mm CEILING ML600C 400 MIMLED 600 CEILING 400 mm CEILING ML600C 600 MIMLED 600 CEILING 600 mm CEILING ML600C 800 MIMLED 600 CEILING 800 mm...
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Page 7: Safety Instructions
1. SAFETY INSTRUCTIONS Please observe the operating instructions when handling the ligh! The light is a class I medical device according to EU 2017/745. Surroundings 1. This device is not intended for operation in potentially explosive areas! 2. Do not use in oxygen-enriched areas! 3. -
Page 8: Brief Description
The lights are used to supply lighting for examination or surgical areas. INTENDED USE MIMSAL MIMLED 600 and MIMLED 1000 are designed for non-invasive, superficial illumination of the entire human body in the visible spectral range for the purpose of examinations, outpatient and inpatient treatments, and surgical procedures by medical professionals. -
Page 9: Operation
3. OPERATION 3.1 CHECK BEFORE EACH USE 1. Check the system for visible deformation. If such are detected, contact service immediately. 2. Ensure that the system has the required hygiene status for use. 3. Before each startup, the entire unit must be checked for proper functioning. The unit should be moved in each degree of movement while checking the main function and the control system. -
Page 10: Operation Of Lamp Head
ON/OFF switch. Heat sink. Adjust brightness in 6 (MIMLED 600) or 10 (MIMLED 1000) steps: (+) increase the illuminance level and ( - ) decrease the illuminance level. Lateral handle strip (for non-sterile operation and positioning of the lamp head). -
Page 11: Working Areas Of The Support Systems
3.3 WORKING AREAS OF THE SUPPORT SYSTEMS 3.3.1 MOBILE STAND MODEL Use of the mobile stand in conjunction with 60º the lamp head allows 360° rotation around the 360º until 35+5º horizontal axis. until 45º The swivel arm of the stand support is mounted vertically and enables a rotation of 60°... -
Page 12: Ceiling Mount Model
3.3.2 CEILING MOUNT MODEL The arms of the ceiling mount are mounted vertically and allow a rotation of 2 x 360° around the vertical axis via the swivel joints. 360º 360º 360º until 35+5º until 45º Figure. Schematic diagram of ceiling attachment... -
Page 13: Wall Mount Model
3.3.3 WALL MOUNT MODEL The arms of the wall mount are mounted vertically and allow a rotation of 360° between the arms and 180° on the wall around the vertical axis via the swivel joints. Do not attach any additional loads to the lamp head or stand/ support. 180º... -
Page 14: Safety Functions
4. SAFETY FUNCTIONS The MIMLED minor surgical lights have built-in safety functions to protect the user and patient during operation. 4.1 PROTECTION AGAINST OVERHEATING In the event that the circuit board overheats (T > 75°C), the light will switch to an emergency lighting mode, with maximum illumi-nance limited to 40,000 lux. -
Page 15: Equipotential Bonding Cunductor
5. EQUIPOTENTIAL BONDING CONDUCTOR An equipotential bonding conductor is an additional conductor (accessory; not included in the scope of delivery) that establishes a direct connection between the electrical unit and the equipotential bonding busbar of the electrical installation. The mobile light on a mobile stand as well as the wall-mounted lights have a PE connection on the housing of the mobile stand or on the wall mount, respectively, so that possible potential differences that can occur as voltage sources are avoided in the patient environment, including in connection with parallel use of... -
Page 16: Reprocessing Of Sterile Accessories
6. REPROCESSING OF STERILE ACCESSORIES The cleaning and disinfection procedures described here have been developed and validated in accordance with the recommendations of the medical societies and the associated standards. In addition to the procedures mentioned here, please also observe your facility’s internal hygiene regulations for cleaning, disinfec-tion and sterilization of medical devices. -
Page 17: Sterilization
6.3 STERILIZATION Sterilization may only be performed on handles that have already been cleaned and disinfected. The sterilization of the blue sterile handle has been validated with the following mechanical procedure and parameters: Sterile handle packaged in paper/laminate Sterilizer class B LISA 522, serial number 08-0794, W&H company Sterilization process: Fractionated pre-vacuum process Temperature: 134 °C Holding time: 18 min. -
Page 18: Cleaning/Disinfection
7. CLEANING/DISINFECTION 7.1 7.1 GENERAL SAFETY INSTRUCTIONS 1. Disconnect the light from the mains before disinfection. 2. Do not use spray cleaner and/or spray disinfectant. Do not spray liquid into sockets or unit openings or allow liquid to penetrate them WARNING: ELECTRIC SHOCK The units may carry electricity and must be handled with care during cleaning and disinfection. -
Page 19: Maintenance
8. MAINTENANCE Medical devices must be subjected to regular maintenance and testing cycles. This is fundamental for compliance with safety concerns. The manufacturer of the medical device is responsible for defining regular safety measures. The operator is responsible for implementing these defined measures. NOTE: Always switch the light to standby mode and disconnect the power plug or disconnect the light from the power supply before carrying out any maintenance or inspection work. -
Page 20: Lamp Head
8.2 LAMP HEAD The following inspections/maintenance must be performed annually: 1. Checking for cracks, deformations in plastic parts and seals. 2. Electrical safety testing. 3. Extended function test. 4. Paint damage. 9. DISPOSAL The light may be operated for a maximum of 10 years after initial commissioning. The unit should then be taken out of service and disinfected and cleaned for disposal. -
Page 21: Mounting Of The Lamp Head
10. MOUNTING THE LAMP HEAD 10.1 LAMP HEAD ASSEMBLY Security element. Figure. Lamp Head accessorie MOUNT LAMP HEAD 1. Disconnect the power plug and secure it against reconnection. 2. Remove the protective flap from the spring arm opening. WARNING: RISK OF INJURY! The spring arm, which is pressed down, can spring up and cause injuries. - Page 22 MOUNT LAMP HEAD 5. Insert the locking segment fully into the slot so that the locking segment can be inserted into the groove. 6. Turn plastic sleeve by 180° and tighten slotted screw. 7. Check that the end unit is securely seated. CAUTION: DAMAGE TO THE UNIT After mounting the lamp head, perform a tilt test according to DIN EN 60601-1.
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Page 23: Mobile Stand Assembly
10.2 MOBILE STAND ASSEMBLY 10.2.1 MOUNT ROLLERS WARNING: STATIC CHARGE If the PE cable is not fitted, the stand unit may become statically charged and discharged onto patients. Mount the PE cable. CAUTION Always attach the braked rollers diagonally, otherwise there is a risk of tipping or slipping. -
Page 24: Mount Stand Tube
MOUNT ROLLERS 5. Fully insert two rollers without brakes. 6. Check that the rollers are securely seated. 10.2.2 MOUNT STAND TUBE CAUTION: DAMAGE TO THE UNIT Without engaging the nose lock and then screwing the stand tube, the stand will fall over. -
Page 25: Mount Safety Ring
MOUNT STAND TUBE 4. Insert the stand tube so that the recess in the tube sits in the nose of the stand base and can no longer be turned. 5. Check for secure seating. 6. Screw in the screw with spring washer again and tighten it firmly. - Page 26 Use of circlip pliers with over-expansion The illustration shows an example of circlip pliers with over-expansion guard (1). The over-expansion guard prevents over-expansion of the circlip. The circlip must not be dismantled without circlip pliers with over-expansion guard (1). Follow the next steps: 1.
- Page 27 In the event of service or maintenance, a new, unused circlip must always be fitted. Insert circlip pliers with over-expansion guard into the eyelets of the circlip (1). The circlip must lie fully and straight in the groove provided. This is checked by the following steps: The circlip (1) must audibly engage in the groove on the trunnion.
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Page 28: Mount Extension Arm With Spring Arm
10.2.4 MOUNT SPRING ARM MOUNT SPRING ARM 1. Unscrew the Phillips screw. 2. Remove the cover cap to the front and upwards. 3. Insert spring arm pin. 4. Push in as far as it will go. - Page 29 MOUNT SPRING ARM 5. Place the washer and secure it with the circlip. The circlip must fit into the groove of the trunnion. This should be checked. (See chapter “10.2.3 Mount Safety Ring”). 6. Establish electrical plug connection. 7. Carefully insert the connection into the tube. 8.
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Page 30: Adjust Spring Force
10.2.5 ADJUST SPRING FORCE Like any technical component, springs are subject to natural wear. Thus, the spring force may decrease after longer operation and must be readjusted. Adjust the spring force so that the spring arm with end unit remains in any desired position. CAUTION: DESTRUCTION OF THE SPRING ARM The spring force is adjusted in the upper end position. -
Page 31: Replacing Fuses
10.2.6 REPLACING FUSES WARNING: ELECTRIC SHOCK For all maintenance work, disconnect the unit from the power supply, pull out the power plug and secure the unit from being switched on again. CAUTION: DAMAGE TO THE UNIT Only the specified fuses (see chapter 12, “Technical Data”, page 44) may be used. REPLACE THE FUSES ON THE MOBILE STAND 1. -
Page 32: Mounting The Wall Fixture And Ceiling Fixture
11. MOUNTING THE WALL FIXTURE AND CEILING FIXTURE NOTA 1. Structural analysis must be carried out before mounting the wall or ceiling fixtures! 2. The load-bearing capacity of the structure must be designed, checked and secured by a structural engineer. 3. -
Page 33: Choice Of Fasteners
11.1 CHOICE OF FASTENERS NOTE 1. The person responsible for the installation is responsible for the safe selection of the fasteners and the safe execution of the fastening. 2. For lightweight walls, we recommend fastening with a counter-plate (not included in delivery). - Page 34 WALL MOUNTING 1. Loosen the side screws on the plastic cover 2. Remove the lower plastic cover. 3. Remove the upper plastic cover. 4. Drill two holes according to the specifications of the manufacturer of the fastener (see page 43). 5.
- Page 35 WALL MOUNTING 8. Attach the two-pole connection terminal (with lever) so that there is a connection terminal on each of the white and black ends of the cable. 9. Open the folding ferrite and place the cable in one half. 10.
- Page 36 WALL MOUNTING 12. Unscrew the Phillips screw and pull the cover cap forward and remove it upward. 13. Push the cable of the extension arm through the trunnion and insert the extension arm with spring arm onto the trunnion of the wall bearing.
- Page 37 WALL MOUNTING 17. Push the upper plastic cover part back up and put it on. 18. Screw the green-yellow cable from the extension arm, as well as the green-yellow cable from the PE connection in the cover flap to the wall bearing bracket. 19.
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Page 38: Mounting The Ceiling Fixture
11.3 MOUNTING THE CEILING FIXTURE 11.3.1 MOUNTING CEILING PANEL WARNING: ELECTRIC SHOCK Disconnect the on-site power supply from the mains and secure it against being switched on again. MOUNT CEILING PANEL 1. Remove the protective. 2. Loosen the three setscrews. 3. -
Page 39: Mounting Extension Arm With Spring Arm
11.3.2 MOUNTING EXTENSION ARM WITH SPRING ARM MOUNT SPRING ARM 1. Unscrew the Phillips screw. 2. Remove the plug 3. Push the extension arm with the spring arm onto the trunnion of the spacer tube. CAUTION: RISK OF INJURY Without the washer and tab washer in place, the circlip can loosen. - Page 40 MOUNT SPRING ARM 4. Put on the washer. 5. Apply the tab washer. 6. Insert the tab washer into the hole and slide the washer over the tube. 7. Pick up circlip with collet. 8. Mount circlip. 9. Check that the extension arm with spring arm is securely seated.
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Page 41: Replacing The Fuse Of The Ceiling Mount
11.3.3 REPLACING THE FUSE OF THE CEILING MOUNT REPLACING THE FUSE OF THE CEILING MOUNT 1. Loosen three setscrews with screwdriver. 2. Pull down canopy. 3. Remove and replace the defective fuse. 4. Insert new fuse. 5. Push the canopy back up and tighten the three setscrews with a screwdriver. -
Page 42: Adjust Spring Force
11.4 ADJUST SPRING FORCE Like any technical component, springs are subject to natural wear. Thus, the spring force may decrease after longer operation and must be readjusted. Adjust the spring force so that the spring arm with end unit remains in any desired position. CAUTION: DESTRUCTION OF THE SPRING ARM The spring force is adjusted in the upper end position. -
Page 43: Drilling Template
11.5 DRILLING TEMPLATE NOTE: The dimensions shown on the drilling template are not on scale! Table. Drilling template for ceiling and wall support... -
Page 44: Data
Service life of medical device [years] Table. Photometric data according to DIN EN 60601-2-41 for MIMLED 1000 and MIMLED 600. All measurements were made at a working distance of 1000 mm. The technical data are subject to certain fluctuations. For technical production reasons, the actual values may differ slightly from the above values. -
Page 45: Electrical And Other Technical Data
12.2 ELECTRICAL AND OTHER TECHNICAL DATA MIMLED 600 MIMLED 1000 Rated voltage 24V DC ± 10% 24V DC ± 10% Rated current 1.0 A @ 24 V 1.0 A @ 24 V Power consumption 24 W Class I Class I... -
Page 46: Physical Characteristics
365 mm 995 mm 115 mm 4,88 Kg Headlamp 600 2,58 Kg 580 mm 560 mm 190 mm 4,62 Kg MIMLED 600 ML600C 200 Support 200 3,08 Kg 220 mm 220 mm 460 mm 4,08 Kg CEILING 200mm 3,68 Kg... -
Page 47: Electromagnetic Compatibility
Emitted interference GUIDELINES AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS The MIMLED 600 and MIMLED 1000 minor surgical lights are intended for use in an ELECTROMAGNETIC ENVIRONMENT as specified below. The user should ensure that the units can be operated in such an environment. - Page 48 10 Vrms fields Please note that the MIMLED 600 and MIMLED 1000 minor surgical lights will go out in the event of a power failure or mains voltage drop. If uninterrupted illumination is required, connect the lights to a power outlet with an emergency power function.
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Page 49: Immunity To High-Frequency Electromagnetic Fields In The
12.5.1 IMMUNITY TO HIGH-FREQUENCY ELECTROMAGNETIC FIELDS IN THE DIRECT VICINITY OF WIRELESS COMMUNICATION DEVICES IMMUNITY OF THE MIMLED 600 | MIMLED 1000 MINOR SURGICAL LIGHTS TO ELECTROMETIC FIELDS IN THE VICINITY OF WIRELESS COMMUNICATIONS DEVICES The MIMLED is intended for use in an electromagnetic environment where RF interference are controlled. -
Page 50: Measures In The Event Of Malfunctions Or Changes In Performance
12.6 MEASURES IN THE EVENT OF MALFUNCTIONS OR CHANGES IN PERFORMANCE In the event of any malfunction or unforeseen change in performance of the fixture, immediately disconnect the fixture from AC power and discontinue fixture operation. Contact your dealer or our service centers for inspection and repair of the device. - Page 51 The light system must be checked for the following points at the intervals specified below by a company authorized by MIMSAL or by personnel with appropriate qualifications Visual and functional check (annually checkout) All parts are free from cracks* The head is free from paint damage*...
- Page 52 Date Signature / Stamp year year Date Signature / Stamp Date Signature / Stamp MIMSAL TRADE S.L. C/ Mollet, 17 Polígono Industrial Palou Nord 08401 – Granollers (Barcelona) SPAIN Tel. +34 930 139 860 mimsal@mimsal com www.mimsal.com Rev. 04 16.01.2023...