M220 F12 User and Installation Manual Ver 01

Thank you for purchasing a Leica Surgical Microscope System. In developing our systems, we have placed great emphasis on simple, self-explanatory operation. Nevertheless, we suggest studying this user manual in detail so that you know and are able to utilize all the benefits of your Leica surgical microscope in an optimum way. For valuable information about Leica Microsystems products and services and the address of your nearest Leica representative, please visit our website, www.leica-microsystems.com Thank you for choosing our products. We hope that you will enjoy the quality and performance of your new Leica surgical microscope. Leica Microsystems (Schweiz) AG Medical Division Max Schmidheiny-Strasse 201 CH-9435 Heerbrugg Phone: +41 71 726 3333 Fax: +41 71 726 3334

Leica M220 F12 / Ref. 10 716 922 / Version 01

Chapter overview

User Manual

Installation Manual

Introduction

4

Controls

5

Preparation Before the Operation

8

Operation

19

Accessories

22

Safety Notes

26

Care and Maintenance

35

Disposal

40

What To Do If...

41

Technical Data

43

General Safety Regulations

49

Preparations

51

Assembly

52

Checklist/Disassembly

56

Instrument Setup

57

Equipment Acceptance and Delivery to the Owner

58

This User Manual and these Assembly Instructions describe the following systems: Leica M220 F12

Leica M220 F12 / Ref. 10 716 922 / Version 01

1

Contents

User Manual

Page

Introduction Design and function

4

Controls Horizontal arm Tilt head/focusing unit Footswitch (standard configuration) Stand Optics carrier Binocular tube, eyepiece, second observer tubes

5 5 5 6 7 7

Preparation Before Surgery Changing accessories of the surgical microscope and balancing the swing arm 8 Installing the binocular tube, eyepiece and objective 9 Installing the adapter for accessories 12 Adjusting the second observer tube 12 Installing documentation accessories 13 Selecting documentation accessories 14 Adjusting the eyebase and eyepoint (optional) 15 Adjusting the parfocality 15 Transporting the surgical microscope 16 Positioning the surgical microscope at the OP stage 17 Mounting sterile components 18 Changing the lamp 18 Starting up the surgical microscope 18 Operation Positioning the microscope Adjusting the focus Adjusting the magnification Adjusting the illumination Adjusting the working distance Decomissioning

19 20 20 21 21 21

Accessories Components and accessories Video accessories for Leica M220 F12 Load table

22 24 25

Safety Notes Intended use of the instrument Information for the person responsible for the instrument User qualifications Directions for the user of the instrument Manufacturer's declaration of electromagnetic compatibility (EMC) Table 1 according to EN 60601-1-2:2007 Table 2 according to EN 60601-1-2:2007 Table 4 according to EN 60601-1-2:2007 Table 6 according to EN 60601-1-2:2007 Dangers during use Signage

2

Page Care and Maintenance Care instructions Maintenance Care and maintenance of the Leica foot switch Replacing the fuse Checking the function of the lamp Changing the lamp Diagnostics in case of malfunctions Notes on reprocessing of resterilizable products Instructions

35 35 35 36 36 36 37 38 38

Disposal Disposal

40

What To Do If... General malfunctions Microscope TV, photography

41 41 42

Technical Data Electrical data Surgical microscope Stand Configurations and Weights Ambient conditions Standards Limitations on use Dimensions

43 43 43 45 45 45 45 46

26 26 26 26 28 28 29 30 31 32 33

Leica M220 F12 / Ref. 10 716 922 / Version 01

Contents/Introduction User Manual

Symbols in this user manual

This user manual contains important safety notes as well as information on using the instrument (see the chapter "Safety notes").

The symbols used in this manual have the following meaning: Warning

Indicates an imminently hazardous situation or improper use that could result in serious personal injuries or death.

Caution

Indicates a potentially hazardous situation or improper use which, if not avoided, may result in minor or moderate injury and/or appreciable material, financial or environmental damage.

Before setting up the product, carefully read through the user manual.

Product identification The model code and the serial number of your product are provided on the nameplate found on the underside of the horizontal arm. Enter this data in your User Manual and always refer to it when you contact us or the service workshop regarding any questions you may have. Type: Serial No.:

Useful information that can help the user operate the product correctly and efficiently. ➩

Leica M220 F12 / Ref. 10 716 922 / Version 01

Action required; this symbol indicates that you need to perform a specific action or series of actions.

3

Introduction

Design and function

1

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2

3

4 5 6 7

8

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11 12 13

Leica M220 F12

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Leica M220 F12 / Ref. 10 716 922 / Version 01

1 Swing arm 2 XY-unit (optional) 3 Focus unit 4 Tilt head 5 Eyepieces 6 Binocular tube 7 Optics carrier 8 Objective 9 Horizontal arm 10 Column 11 Footswitch holder 12 Base 13 Footswitch

Controls

Horizontal arm 1 Connection for footswitch Only connect the footswitch provided by Leica ­Microsystems (Schweiz) AG, Medical Division 2 Power switch 3 Power connection 4 Cable holder for footswitch cable 5 Power cable strain relief device

1

2 4

3

5

Tilt head/focusing unit Tilt head 1 Clamping lever for manual tilt movement Focusing unit 2 XY-unit reset button

2

1

Footswitch (standard configuration) 2

1

1 Focus up and down 2 XY adjustment 3 Magnification change The assignment of 1 and 3 (magnification and focus control) can be switched. For additional information, refer to the service manual or ask your local after-sales service.

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Leica M220 F12 / Ref. 10 716 922 / Version 01

5

Controls

Stand 3 2

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1

4 5

6

Leica M220 F12 / Ref. 10 716 922 / Version 01

1 Rotary knob for joint brake 2 Rotary knob for balancing 3 Brake knob for locking the ­vertical position 4 Footbrake release lever 5 Footbrake

Controls

Optics carrier 1 2 3 4

Magnification indicator Handles Illumination switch and control Inserts for filter (UV protection filter GG475, protection filter 5×)

1 2 4

3

5 Emergency drive for the magnification changer In case of emergency, the magnification can be adjusted on the emergency drive using a coin or the like.

5

Binocular tube, eyepiece, second observer tubes 1 Drive knob for interpupillary distance adjustment (optional) 2 Dioptric adjustment 3 Knurled ring for image correction

2

1

3

Leica M220 F12 / Ref. 10 716 922 / Version 01

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Preparation Before Surgery

Changing accessories of the surgical microscope and balancing the swing arm

2 1

3

Warning Risk of injury from the surgical microscope swinging down! ➩ Lock the swing arm ➩ Never change the accessories or attempt to rebalance the microscope while it is above the field of operation. ➩ Balance the swing arm each time after changing accessories. Locking the swing arm ➩ Position the swing arm (1) approximately horizontally. ➩ Tighten the brake knob for locking the vertical position (2). The swing arm is now locked. Cleaning the optical accessories ➩ Inspect the cleanliness of the eyepieces and objective as well as any photo or TV adapters as appropriate. ➩ Remove dust and dirt. Installing the accessories ➩ Outfit the microscope with all accessories for use. Balancing the swing arm ➩ Hold the microscope firmly. ➩ Loosen the brake knob for locking the vertical position (2). The swing arm is now released. ➩ By moving the swing arm manually, determine whether more force is required to move it upwards or downwards. If more force is required to move it upwards: ➩ Turn the balancing knob (3) in the direction of the larger weight (counterclockwise). If more force is required to move it downwards: ➩ Turn the balancing knob (3) in the direction of the smaller weight (clockwise). When adjusting the brake force, note that the upwards movement force is slightly less than the downwards force.

8

Leica M220 F12 / Ref. 10 716 922 / Version 01

Preparation Before Surgery

Installing the binocular tube, eyepiece and objective Installing the binocular tube ➩ Unscrew the clamping screw (1). ➩ Push binocular tube into the dovetail ring. ➩ Tighten the clamping screw securely. 1

The surgical microscope can be adjusted to fit any work situation. Warning Risk of injury from the binocular tube falling down! ➩ Tighten the clamping screw securely.

Inclined binocular tube

Binocular tube 5°–25°

Inclined binocular tube 45° Optional for use on the assistant attachment (not a standard configuration)

Leica M220 F12 / Ref. 10 716 922 / Version 01

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Preparation Before Surgery Installing the eyepiece ➩ Set the eyepiece in place. ➩ Tighten the rotary ring (1). Eyepieces Eyepiece 10×, TC Eyepiece 10×/21B, adjustable Eyepiece 8.33×, adjustable Eyepiece 12.5×/17B, adjustable Leica ToricEyePiece

1

Installing the objectives Objectives screw onto the microscope with a right-hand thread. Objectives Objective WD = 175 mm APO Objective WD = 200 mm APO Objective f = 175 mm Objective f = 200 mm Objective f = 225 mm

Installing the protective objective glass ➩ Fit the objective protection glass holder (2) to the objective and position it so that the marking (3) faces back. ➩ Hold the objective protection glass (5) in position and turn slightly to the right. The protective objective glass engages, the marks (3) and (4) are positioned one above the other.

2

3

The protective objective glass is not autoclavable.

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Leica M220 F12 / Ref. 10 716 922 / Version 01

Preparation Before Surgery Inserting additional filters The Leica M220 F12 features two slots for additional filters. You can use temperature-resistant filters with a diameter of 32 mm. For further information, please contact your Leica Microsystems representative. ➩ Pull out the 2 empty filter holders (1). ➩ Fasten the filter in the filter holder. ➩ Reinsert the filter holder (1).

1

Leica M220 F12 / Ref. 10 716 922 / Version 01

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Preparation Before Surgery

Installing the adapter for accessories Installing the beam splitter/stereo adapter ➩ Tighten the clamping screw (1). ➩ Push the beam splitter/stereo adapter into the dovetail ring. ➩ Tighten the clamping screw. 1

Beam splitter with 50/50 % observation, alternative: beam splitter with 70/30 % observation

1

Installing the adapter ➩ Insert the adapter in the beam splitter. ➩ Tighten the rotary ring (1).

Adjusting second observer tube 1

12

Attach the stereo attachment/second observer tube. ➩ Insert stereo attachment/second observer tube into beam splitter. ➩ Tighten the rotary ring (1).

Leica M220 F12 / Ref. 10 716 922 / Version 01

Preparation Before Surgery Stereo attachment for second observer The dual stereo attachment can be attached to the left or right on the beam splitter and turned any direction.

Adjusting the second observer tubes ➩ Rotate the monocular second observer tube in the desired direction. ➩ Adjust the diopter setting at the eyepiece. ➩ Correct the image with the knurled ring (2).

2

Adjusting the stereo attachment for second observer ➩ Turn the attachment for second observer in the desired direction. ➩ Align the binocular tube horizontally. ➩ Adjust the diopter setting at the eyepiece. ➩ Correct the image with the knurled ring (2).

Installing documentation accessories Adjusting the magnification

Focusing knob

Warning Risk of injury from parts falling down! ➩Complete all preparations and adjustments on the optics carrier before the operation. ➩Never rebalance or re-equip the optical components and accessories with the instrument over the operation area. ➩Check that the optical components and accessories fit well and are fastened securely before the operation. ➩Before changing equipment during an operation, swivel the microscope away from the operation area.

Leica M220 F12 / Ref. 10 716 922 / Version 01

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Preparation Before Surgery

Selecting documentation accessories Zoom video adapter

TV attachment

35 mm

Photo/TV dual attachment

55 mm

60 mm

TV attachment

70 mm

Photo/TV dual attachment

85 mm

Zoom video adapter

100 mm

TV attachment

107 mm

1/4 “

1/3 “

1/2 “

2/3 “

1“

Photo/TV dual attachment

250 mm

350 mm

35 mm

Digital Photo Camera

Field of view Monitor/image

14

Leica M220 F12 / Ref. 10 716 922 / Version 01

Preparation Before Surgery

Adjusting the eyebase and eyepoint (optional) Interpupillary distance scale

The distance between both pupils and the desired contact with the eyepieces are adjusted individually. You can prepare the surgical microscope before the operation using the data from a user table.

75

Adjusting the interpupillary distance ➩ Set the eyelenses of the eyepieces to "0" or select the required diopter value. ➩ Set the magnification changer to step 10. ➩ Look into the eyepieces and adjust the tubes with the setting wheel or by hand (in the case of binocular tubes without a setting wheel) until a circular field of view is visible.

65 55

Setting wheel

Adjusting the parfocality

Rotary ring for adjusting the diopters

Adjusting the diopter settings Adjust the diopter settings accurately for each eye separately; only this method will ensure that the image will stay in focus throughout the entire magnification range (parfocal). 1. Prepare the microscope ➩ Switch on the microscope at the control unit and place a flat test object such as a piece of paper beneath the objective. ➩ Set the maximum brightness. ➩ Set the minimum magnification. ➩ Shift the microscope until the test object is visible in the center of the field of view and reasonably sharp. 2. Focus on the test object ➩ Set the maximum magnification. ➩ Focus the microscope. ➩ Set the minimum magnification. 3. Adjusting the diopter settings ➩ Adjust the diopter setting for each eye in turn, until the image is seen in sharp focus. ➩ Set the maximum magnification. ➩ Focus the microscope again. ➩ Set the minimum magnification. ➩ Inspect the diopter settings, readjusting them if necessary so that both images are sharp. 4. Checking parfocality ➩ Observe the test object while zooming through the whole range. The image sharpness must remain constant at all magnifications. If it does not, then repeat points 2 to 4 of this procedure.

Leica M220 F12 / Ref. 10 716 922 / Version 01

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Preparation Before Surgery

Transporting the surgical microscope

Caution The swinging arm can swing out uncontrollably! ➩ When transporting the surgical microscope, always return it to the transport position.

1

2 3

3

Locking the swing arm ➩ Position the swing arm (1) approximately horizontally. ➩ Tighten the brake knob for locking the vertical position (2). The swing arm is now locked. ➩ Release the articulation brakes (3) and fold up the swing arm. Due to the rotation stop, the swing arm can be moved in one direction only using the horizontal arm. ➩ Move the surgical microscope into transport position and tighten the articulation brakes.

Caution Feet in lightweight shoes can become trapped beneath the base of the stand! ➩ Always push the surgical microscope; never pull it.

3

Transporting surgical microscope and securing it in a new location ➩ Unplug the power plug from the instrument. ➩ Remove the footswitches from the instrument. ➩ Step on the footbrake release lever (4) to release the footbrakes. ➩ Push the surgical microscope to its installation location at the column (5). ➩ Lock the footbrakes at the installation location.

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4

16

Caution Surgical microscope can move without warning! ➩ Always secure the footbrakes when you are not moving the system.

Leica M220 F12 / Ref. 10 716 922 / Version 01

Preparation Before Surgery

Positioning surgical microscope over operating table

Warning Risk of death from electrical shock! ➩ The surgical microscope may be connected to a grounded socket only. ➩ Carefully move the surgical microscope at the column to the operating table and position it for the forthcoming operation. ➩ Tighten the footbrakes. ➩ Connect the power cable (2) to the socket. ➩ Connect the footswitch in the socket (1) to the horizontal arm and guide it through the cable guide (3).

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2 3

4 5

➩ Inspect all terminals and make certain that all accessories are seated firmly. ➩ Release the articulation brakes and set them to a light resistance. To make the joint easier to move: ➩ Release the articulation brake (5).

5 5

To make the joint more difficult to move: ➩ Tighten the articulation brake (5). ➩ Loosen the brake knob for locking the vertical position (4). ➩ Extend the swing arm. ➩ Check the weight setting on the swing arm by raising and lowering the microscope and correct as necessary, see page 8. Caution Danger of infection! ➩ Leave sufficient space around the stand to prevent contact with non-sterile components.

Leica M220 F12 / Ref. 10 716 922 / Version 01

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Preparation Before Surgery

Attaching the sterile components

Standard components: • 2 handles, transparent • 1 drive knob (Illumination switch) The handles and drive knob can be sterilized via steam or gas. ➩ Sterilize the handles and drive knobs. ➩ Attach the sterile drive knob to the rotary knob for illumination. ➩ Attach the sterile handles to the optics carrier.

Checking the function of the lamp ➩ Switch on the microscope using the power switch. The main lamp is illuminated. ➩ Turn the button (1) to the right. This increases the brightness. Warning Failure of the illumination can be dangerous for the patient! ➩ Keep a compatible replacement lamp ready.

1

Starting up the surgical microscope ➩ Switch on the power switch (2). The light is switched on and the XY-unit moves to the reset position.

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Leica M220 F12 / Ref. 10 716 922 / Version 01