Related Manuals for Leica M530 OHX
Summary of Contents for Leica M530 OHX
- Page 1 Leica M530 OHX Leica M530 OHX User Manual User Manual 10 745 219 - Version 04 10 745 219 - Version 04...
- Page 2 The information provided by this manual is directly related to the operation of the equipment. Medical decision remains the responsibility of the clinician. Leica Microsystems has made every effort to provide a complete and clear user manual highlighting the key areas of product use. Should additional information regarding the use of the product be required, please contact your local Leica representative.
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Page 3: Table Of Contents
Selecting the assistant Stand settings 15.3 Table 4 from EN 60601-1-2 Positioning on the operating table Annex Attaching sterile controls and drape 16.1 Checklist before the operation 7.10 Function check Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 4: Introduction
Enter this data in your user manual and always refer to it when In this user manual the surgical microscopes Leica M530 OHX is you contact us or the service workshop regarding any questions described. -
Page 5: Safety Notes
Allocate responsibilities for commissioning, operation and maintenance. Monitor compliance with this. Only use the Leica M530 OHX surgical microscope if it is free of defects. Inform your Leica representative or Leica Microsystems (Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland, immediately about any product defect that could potentially cause injury or harm. -
Page 6: Dangers Of Use
Danger of injury due to movement of the microscope during illuminated image. the balancing process. Do not sit or stand immediately next to the microscope during the balancing process. Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 7 If the field diameter is greater than the field of view and the light intensity is too high, uncontrolled tissue heating may occur outside of the area visible through the microscope. Do not set the light intensity too high. Leica M530 OHX / Ref. 10 745 219 / Version 04...
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Page 8: Signs And Labels
Safety notes Signs and labels Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 9 «Qualité hôpital». appropriate shielding. Laser label Warning trained personnel Monitor arm weight LAMP 2 Lamp number with label danger sign for hot Warning use Xenon surface LAMP 1 Bulbs Leica M530 OHX / Ref. 10 745 219 / Version 04...
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Page 10: Design
11 Terminals 12 Camera and recording unit (optional) 13 Handle 14 Monitor arm With its open architecture the Leica M530 OHX provides space for holding the camera and recording units. Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 11: Leica M530 Optics Carriers
• Back assistant interface with fine focus knob • Leica FL800 ULT/GLOW800 system components built into the common housing of the ULT • For use with Image Injection Module Leica CaptiView Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 12: Functions
Leica FL560 for M530 / Leica FL800 ULT / GLOW800 Balancing system With a balanced surgical microscope Leica M530 OHX you can move the optics carrier in any position without tilting or falling down. After balancing all movements during operation only need a minor force. -
Page 13: Brakes
The button of the handle with the assigned function "Selected Brakes" (refer also to the chapter on "Assigning handles", page 44) can trigger two different brake combinations: "Focus Lock" or "XYZ Free". Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 14: Illumination
Luminous energy The optics of the Leica Leica M530 OHX surgical microscope have a variable working distance of between 225 and 600 mm. The system is designed in such a way that it delivers sufficient light to produce a bright image even at a long working distance of 600 mm. -
Page 15: Leica Fusion Optics
BrightCare Plus display Leica M530 is equipped with the Laser focussing aid Leica SpeedSpot. If Leica SpeedSpot is activated for the current user (see page 45), the focussing aid is released when the brakes are released or when focussing. Two convergent light beams meet exactly in the focussing point of the microscope. -
Page 16: Controls
8 Leica M530 surgical microscope 9 Handle clamping lever 10 Push button for intraoperative AC/BC balancing (not available for Japan) 1 Locking in horizontal direction 2 Locking in vertical direction Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 17 Leica M530 with Top plate / Leica M530 with IVA530 Leica M530 with ULT530 and Leica FL800 ULT or Leica M530 with ULT530 and Leica FL400 for M530 / Leica M560 for with Leica FL400 for M530 / Leica FL560 for M530...
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Page 18: Control Unit
* May not be used during surgery ** Connect medical equipment only 1 Touch panel 2 Push-button with illumination LED (On/Off) 3 Push-button with illumination LED for Auto Balance Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 19: Stand
1 Magnification 2 Working distance 3 Release preselected brakes Assignment in the factory setting 1 Magnification 2 4-function joystick 3 Working distance 4 Release all brakes 5 Release preselected brakes Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 20: Footswitch
Footswitch Mouthswitch • 12 functions • 16 functions • lengthwise • lengthwise Footswitch Footswitch 1 Release "XYZ Free" brakes • 12 functions • 14 functions • crosswise • crosswise Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 21: Preparation Before Surgery
Make sure that the movement range is free. CAUTION Surgical microscope can move without warning. In case the Leica M530 OHX is not in transport position, refer Always lock the footbrake when you are not moving the to section 8.4. -
Page 22: Locking/Unlocking The Leica M530 Ohx
(Leica M530 with IVA530 only) Leica M530 OHX 90° To unlock the Leica M530 OHX, pull the locking knob for vertical or horizontal direction and rotate 90°. Remove the cover (1) from the c-mount adapter. The red dot on the stand is facing the black dot on the knob. -
Page 23: Setting The Binocular Tube
Select the highest magnification and check the sharpness. 7.5.2 Adjusting the pupillary distance Rotate the eyecups up or down until the desired distance is set. Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 24: Selecting The Assistant
Risk of damage to the surgical microscope. Do not balance in A/B direction further than the 20° positions. Using knob (1) switch the light from the back assistant to the side assistants. Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 25 The balancing procedure can be canceled at any time using "Interrupt Balancing". The first balancing step is completed when the acoustic signal no longer sounds and the autobalancing push-button is no longer flashing. Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 26 The microscope must remain fixed in any position. During the balancing procedure, the push-button flashes yellow and an acoustic signal sounds (can be deactivated in the service menu). Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 27 Check the balancing. Risk of damage to the surgical microscope. Press the "All Brakes" button on the handle. Do not balance in A/B direction further than the 20° positions. Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 28 Move the A-axis until the optics carrier is balanced. Optics carrier tilting back move A-axis forwards (to the right) Optics carrier tilting forwards move A-axis back (to the left) Leica M530 OHX / Ref. 10 745 219 / Version 04...
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Page 29: Positioning On The Operating Table
Risk of damage to the surgical microscope due to collision. Make sure that there is free space of about 1 m around the foot. The Leica M530 OHX can be positioned easily on the operating table and offers a variety of possibilities for operations on the head or spinal column. -
Page 30: Attaching Sterile Controls And Drape
Preparation before surgery The Leica M530 OHX achieves this large range of positions through Notes on positioning its very long and high arm system. Release the footbrakes (see page 19). Move the Leica M530 OHX surgical microscope carefully over to the operating table by the handle and into the required position for the operation. -
Page 31: Function Check
Place the sterilized protective glass on the optics carrier so that ribbons. It must still be easy to move the instrument. the markings on the Leica M530 (1) and on the protective glass Check the ease of movement of the instrument. -
Page 32: Operation
2 with button (1). To guarantee a good light performance the life time shall not Check the fiber optics cable connection to the optics carrier. exceed 500 hours. Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 33: Positioning The Microscope
On the handswitch/footswitch/handle Depending on the assignment (see page 43), you can also increase and decrease the brightness of the main illuminator using two correspondingly assigned buttons on the handswitch/ footswitch/handle. Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 34 Click the yellow "BrightCare plus" button again. When shipped from the factory, the "BrightCare Plus" safety "BrightCare plus" is now activated and the button is again lit function is activated for all users green. Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 35 Thanks to AutoIris, the field diameter is automatically adapted to luminosity and is no longer sufficient either for blue light the size of the field of view at the Leica M530 optics carrier. (FL400 application only) or for white light (all other applications).
- Page 36 5. • You can adjust the magnification motor speed in the "Speed" menu. • These values can be saved individually for each user (see page 40). Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 37 The working distance changes. the microscope to laser distance and lock the microscope in position. Do not adjust the rotary button for manual setting of the working distance while using the laser. Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 38 The yellow LED (2) turns off and the working distance is correct individual diopter settings. This command can be as well released. given on the GUI and from the handle, if defined. Leica M530 OHX / Ref. 10 745 219 / Version 04...
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Page 39: Transport Position
Operation Transport position Shutting down the surgical microscope Press the "All Brakes" button and move the Leica M530 OHX into the transport position. If present, turn off the recording system according to the manufacturer's instructions. NOTE Switch off the light at the light switch. -
Page 40: Control Unit With Touch Panel
3 Display range 4 Dynamic button bar 5 Warning messages In operational mode, the status line displays the current user and specifies the current location in the menu at all times. Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 41 Presets The "User List" opens a two-page user list from which you can You can find a list of default users preset by Leica for the most select one of up to thirty users that can be saved. common types of operation under "Presets".
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Page 42: Menu - User Settings
"Edit User List" Allows to rename, to move or to delete users. cables during the preparation of the system prior to the surgery. Not well fitted parts and bad connections can lead to hazardous situations and system failures. Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 43 If the re-entered password/PIN does not match the enter/re-enter process has to be repeated. If no password/PIN should be defined, you can exit the procedure by pressing “Skip” or before re-entering with “Cancel”. Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 44 If "WD Reset" is activated, the working distance motor automatically moves to the working distance saved for each user in the user settings when "All Brakes" are released. This function is deactivated in the factory default configuration. Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 45 You can also connect the optional 6-function footswitch to the Function" element - which can be found in all function groups Leica M530 OHX. The 6 available switches work similar to those - and assign it to the key in question.
- Page 46 The inner switch (2) to which "Selected Brakes" is pre-assigned can be freely assigned, as required. You can also assign one of the five defaults "X/Y", "FL400", "DIC", "GLOW800" or "FL560" completely to each handle. Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 47 • When activated, the objective is automatically brought into working distance at maximum magnification. • When deactivated, the objective is automatically brought into working distance at the current magnification settings. Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 48 Risk of damage. Only move the surgical microscope when all brakes are released. Click the "Save" button to save the user at the desired location under the name you have entered. Leica M530 OHX / Ref. 10 745 219 / Version 04...
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Page 49: Menu - Maintenance Menu
A dialog window informs you when the xenon lamp is losing luminosity and is no longer sufficient either for blue light (FL400 application only) or for white light (all other applications). Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 50: Menu - "How To
30°–150° and eyepiece with 10 magnification. This area is password-protected. Before starting the service menu, end the recording procedure on the documentation system. Otherwise data could be lost. Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 51: Accessories
Devices and accessories A comprehensive range of accessories enables the Leica M530 OHX surgical microscope to be matched to the requirements of the task in hand. Your Leica representative will be pleased to help you select Mouth Switch the appropriate accessories. - Page 52 • Leica AutoFocus • Leica CaptiView Cart • ITD for 31" and 55" Monitor See the corresponding instruction for use. Do not use third party products without premission of Leica. Leica M530 OHX / Ref. 10 745 219 / Version 04...
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Page 53: Care And Maintenance
Use a commercially available glass/eyeglass cleaner or plastic cleaner to clean the touch panel. Do not apply pressure to the touch panel while cleaning it. It is recommended to conclude a service contract with Leica Service. Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 54: Changing Bulbs
CAUTION Danger of skin burns. The lamp insert gets very hot. Check that the cover has cooled before you replace the lamp. Do not touch the hot lamp insert. Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 55: Notes On Reprocessing Of Resterilizable Products
Use some rinsing agent depending upon degree of deviation from the supplied instructions should also be examined contamination. carefully by the processing person to determine effectiveness and possible detrimental consequences. Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 56 1) This medical device falls within the validated sterility claims of the STERRAD®100S / STERRAD® 100NX™ / STERRAD®50 / STERRAD®200 Systems. Please follow the instructions for use of your STERRAD® System User's Guide prior to sterilizing devices in STERRAD® Systems. Leica M530 OHX / Ref. 10 745 219 / Version 04...
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Page 57: Disposal
Automatic balancing has not been Make sure that position B has been assumed (see can be moved only with difficulty or not completed. page 24). at all. Press the push-button for auto-balance again. Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 58 Switch the device on again using the main switch. This power the power supply has been interrupted. will reset the circuit breaker. If this has to be done repeatedly, please inform Leica service. Leica M530 OHX / Ref. 10 745 219 / Version 04...
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Page 59: Malfunctions Documentation Accessories
The push button for Illumination on/off flashes. "Luxmeter is defective" Contact your Leica representative. "Microscope device controller Contact your Leica representative. not available" Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 60: Specifications
Leica FL800 (PAL) Leica FL800 Observation filter module Leica FL800 (NTSC) Fine focus Available for back side assistant Magnification 1.4× multiplier IR sensor For remote control of the Leica HD C100 Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 61 1 brake for A/B axis 1 brake for C axis Indicator LED for Fluorescence mode status LED for Video record status IR sensor for remote control of the external Leica HD C100 camera Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 62 Specifications Leica M530 with Leica FL800 ULT Leica M530 with Leica FL400 for M530 / Leica FL560 for M530 and Leica FL800 ULT Integrated camera Leica HD C100 built-in 1/2.8" progressive 1-chip for visible light CMOS (optional) Integrated camera Leica HD C100 built-in 1/2.8" progressive 1-chip...
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Page 63: Leica Ohx Floor Stand
700 mm long and flexible arm with 4 axis for rotation and inclination to carry optional video monitor Materials All solid metal construction Surface coating Coated with antimicrobial paint system Minimum height In park position: 1945 mm Leica M530 OHX / Ref. 10 745 219 / Version 04... -
Page 64: Limitations Of Use
Specifications 14.6 Limitations of use The Leica M530 OHX may be used only in closed rooms and must be placed on a solid floor. The Leica M530 OHX is not suitable for crossing thresholds higher than 20 mm. To move the surgical microscope over thresholds of 20 mm, the wedge (1) included in the packaging can be used. -
Page 65: List Of Weights Of Balanceable Configurations
Inclined Tube Magn. Inclined Tube Multipl. Straight Tube Camera Tube 30°-150° Stereo Attachment 45° Tube 1 or 2 side assistants, switchable - only one active Tube for 2nd Observer Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 66 0.10 kg Eyepiece 12.5x Max. 1 camera Camera Recommended: Leica HD C100 0.12 kg C-mount camera M = Must, O = Option, S = Selection continued on next page Load Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 67 0-3 pieces, (main, side) 10448245 Mouth switch 10446058 Protective glass 0.22 kg IGS Frame 0.02 kg Load from previous page Total M = Must, O = Option, S = Selection Load Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 68 ULT530. Tube for 2nd Observer Optional: Side assistant Stereo Attachment Inclined Tube Tube 30°-150° Straight Tube Magnification Multiplier Tube 30°-150° Tube 0°-180° Tube 0°-180° 45° Tube CaptiView Tube 30°-150° Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 69 Only 1 piece, only main surgeon and 0.28 kg only with binocular tube 30°-150° (vignetting) 10449016 Leica HD C100 for ULT530 M = Must, O = Option, S = Selection continued on next page Load Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 70 M = Must, O = Option, S = Selection Load NOTE Destruction of the ULT530 optics. Do not use the Zoom Video Adapter in combination with the Leica M530 with ULT530. Leica M530 OHX / Ref. 10 745 219 / Version 04...
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Page 71: Dimensional Drawings
Specifications 14.8 Dimensional drawings ±270° ±50° ±50° ±40° +120° -30° 2685 1200 max. 1925 Dimensions in mm Leica M530 OHX / Ref. 10 745 219 / Version 04... - Page 72 Specifications 690×690 Dimensions in mm Leica M530 OHX / Ref. 10 745 219 / Version 04...
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Page 73: Manufacturer's Declaration Of Electromagnetic Compatibility (Emc)
The Leica M530 OHX surgical microscope is intended for operation in an environment as specified below. The customer or the user of the Leica M530 OHX surgical microscope should make sure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –... - Page 74 - interruptions on the HD Montior Non of the listed effects above have an impact on the essential performance or safety and effectiveness of the Leica M530 OHX surgical microscope. Its no unacceptable risk for User, Patient or environment to be expected.
- Page 75 Leica M530 OHX surgical microscope, this can lead to an increase in electromagnetic radiation or a reduction in EMC. The Leica M530 OHX surgical microscope must not be used directly adjacent other instruments. If it is necessary to operate it in the vicinity of other instruments, the devices should be monitored to ensure that they function properly in this arrangement.
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Page 76: Annex
(if used) for cleanliness. Remove dust and dirt. Installing the accessories Lock the Leica M530 OHX in place and install all accessories on the microscope so it is ready for use (see page 20). Position the handles as desired. - Page 77 Leica M530 OHX / Ref. 10 745 219 / Version 04...
- Page 78 CONNECT 10 745 219en/04• Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2020 • Printed – 08.2020 – Subject to modifications. WITH US! • LEICA and the Leica Logo are registered trademarks of Leica Microsystems IR GmbH.