Leica M501 User manual

Leica M501

User manual

10 711 785 – Version D

Leica M501 / Ref. 10 711 785 / Version D

Chapter Overview

1

Leica M501 / Ref. 10 711 785 / Version D

Introduction 3

Controls 7

Preparation for Operation 9

Use 19

Safety Notes 22

Care and Maintenance 32

Messages and Warnings 36

Technical data 37

Table of Contents

2

Leica M501 / Ref. 10 711 785 / Version D

Page

Introduction

Design and function 4
Ceiling mounts 5

Controls

Control unit/lamp housing 6
Tilt head/focusing unit 6
Footswitch 6
Handswitch 7
Stand 7
Remote control for Leica Telescope Mount 7
Optics carrier 8
Binocular tube, eyepiece, tubes for second observer 8

Preparation for Operation

Retrofit the surgical microscope and balance
the swinging arm 9
Attach the binocular tube, eyepiece and objective 10
Set the interpupillary distance and eyepoint 12
Adjust for parfocality 12
Attach the adapter for accessories 13
Adjusting second-observer tube 14
Display/change the footswitch type 15
Switch the plus/minus movement directions
of the XY-unit 15
Disable/enable the function of the XY-Reverse button 15
Transport the surgical microscope 16
Position the surgical microscope at the OP stage 17
Sterile components 18
Setting the rest position on the Leica
Telescope Mount 18
Setting the rest position on the Leica Mini Mount 19

Use

Operating the surgical microscope 19
Positioning the microscope 20
Adjusting the focus 20
Adjusting the magnification 20
Adjusting the illumination 21
Setting the illumination type and the working distance

21

Safety Notes

Intended use 22
Directions for the operator of the instrument 22
Directions for the user of the instrument 22
Table 201 according to EN 60601-1-2:2001 23
Table 202 according to EN 60601-1-2:2001 24
Table 204 according to EN 60601-1-2:2001 25
Table 206 according to EN 60601-1-2:2001 26
Hazards associated with instrument use 27
Signs and labels 28

Page

Care and Maintenance

Changing the fuse 32
Changing the bulb 33
Inspecting the functioning 33
Notes on reprocessing of resterilizable products 34

Messages and Warnings

Ventilation 36
General malfunctions 36

Technical data

Electrical data 37
Microscope 37
Stands 38
Swing arm 39
Ambient conditions 39
Limitations of use 39
Standards 39
Dimensions 40

Introduction

3

Leica M501 / Ref. 10 711 785 / Version D

User manual

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

Before attempting to set up the product, carefully
read through the user manual.

Product identification

The model code and serial number of your product are provided
on the nameplate found on the underside of the control unit.
Write this data into your User Manual and always refer to it
when you contact us or the service workshop regarding any
questions you may have.

Model: Serial No.:

Symbols used in this manual

The symbols used in this user manual
have the following meanings:

Warning regarding use hazard or

Warning noncompliant use that can lead to

serious injury or death.

Warning regarding use hazard or non-

Caution compliant use that can lead to minor

injury, but significant article, property
or environmental damage.

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

Request for action; here, you are
requested to take action.

➩

Introduction

4

Leica M501 / Ref. 10 711 785 / Version D

Design and function

1 Base
2 Control unit/lamp housing
3 Swing arm
4 XY-coupling (optional)
5 Tilt head
6 Focusing unit
7 Optics carrier
8 Binocular tube
9 Eyepieces

10 Objective

Floor stand

1

3

2

4
5

8

9

10

6
7

Introduction

5

Leica M501 / Ref. 10 711 785 / Version D

Ceiling mounts

1 Mini Mount ceiling mount

1

2 Leica Telescope Mount

2

6 Leica M501 / Ref. 10 711 785 / Version D

Controls

Control unit/lamp housing

2

1

•

XY-Reverse

Tilt head

3 Tilt head fine adjustment
4 Brake knob for rough adjusting

the tilt

Focusing unit

1 XY-unit reset button
2 Focus reset button

5

4

+

-

7

1

2

3

6

5

4

+

-

3

7

1

2

6

Footswitch

Cross pedal variant Vertical pedal variant

1 Main switch
2 Regulating knob for adjusting the travel speed of the

XY-coupling

3 Regulating knob for adjusting the travel speed of the

focus

4 Regulating knob for adjusting the travel speed of the

zoom

5 Regulating knob for adjusting the brightness of the

illumination
6 Rotary knob for changing filters
7 Turn grip for the quick-change lamp mount

1 XY adjustment
2 Focus up and down
3 Zoom up and down
4 Greater illumination
5 Less illumination
6 XY-Reverse
7 Microscope illumination on/off

Tilt head/focusing unit

3

4

6

7

2

3

4

51

7Leica M501 / Ref. 10 711 785 / Version D

Controls

Handswitch

1 XY adjustment
2 Focus up and down
3 Zoom up and down
4 Greater illumination
5 Less illumination
6 XY-Reverse
7 Microscope illumination on/off

Stand

1 Footbrakes
2 Footbrake release lever
3 Articulation brakes
4 Balance turn knob
5 Safety hook
6 Retaining pin

3

33

3

4

1

2

5

6

Remote control for Leica Telescope Mount

1

1 Buttons for up/down movement

45

SL

XY

1

3

2

ZF

7

A

ML

6

8 Leica M501 / Ref. 10 711 785 / Version D

Controls

Optics carrier

1 Turn knob for fading ambient lighting
2 Handles

+5 -5 +5 -5

Binocular tube, eyepiece, tubes for second observer

1 Drive knob for adjusting the interpupillary distance
2 Diopter adjustment
3 Knurled ring for image correction

1

3

3

2

9Leica M501 / Ref. 10 711 785 / Version D

Preparation for Operation

Lock the swing arm.

➩ Position the swing arm approximately horizontally.
➩ Pull out the retaining pin (3).
➩ Move the swing arm slightly up and down until the safety

hook (2) engages.
The swing arm is now locked.

Clean the optical accessories

➩ Inspect the eyepieces, objectives and any present photo and

TV-adapters for cleanliness.

➩ Remove dust and dirt.

Fitting accessories

➩ Equip the microscope ready for use with all necessary

accessories.

Balance the swing arm

➩ Hold the microscope firmly.
➩ Move the swing arm slightly up and down, at the same time

pushing the counterlever of the safety hook (2) upwards,

until the retaining pin clicks into position.
➩ See whether or not the microscope drifts.
Microscope drifts downwards:
➩ Turn rotary knob (4) clockwise.
Microscope drifts upwards:
➩ Turn rotary knob (4) counter-clockwise.

Warning 1
Risk of injury from the surgical microscope swinging
down!

➩Never rebalance or re-equip with the instrument over

the field of operation.

➩After re-equipping, always rebalance the swinging

arm.

Retrofit the surgical microscope and
balance the swinging arm

2

3

10 Leica M501 / Ref. 10 711 785 / Version D

Preparation for Operation

Attach the binocular tube, eyepiece and
objective

Binocular tube 10° – 50°, ultra low

Binocular tube 10° – 50°, low

Binocular tube with variable 180°

Binocular tube var. 30° – 150°

Attach the binocular tube

➩ Unscrew the clamping

screw (1).

➩ Push the binocular tube into

the dovetail ring.

➩ Tighten the clamping screw.

A range of options enables the Surgical Microscope to be
matched to the requirements of the task in hand.

Inclined binocular tube

Straight binocular tube

Inclined binocular tube 45°

Optional for use on the assistant’s
attachment
(no standard configuration)

1

11Leica M501 / Ref. 10 711 785 / Version D

Preparation for Operation

Fitting the eyepiece

➩ Set the eyepiece in place.
➩ Tighten the rotary ring (1).

Eyepieces

Eyepiece 10x/21B, adjustable
Eyepiece 12.5x/17B, adjustable

Fitting objectives

Objectives are screwed in on the microscope with right-hand
threading.

Objectives

Objective WD = 175mm APO
Objective f = 175mm
Objective f = 200mm
Objective f = 225mm
Objective f = 250mm
Objective f = 275mm
Objective f = 300mm

1

12 Leica M501 / Ref. 10 711 785 / Version D12

Preparation for Operation

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.

Regulate the interpupillary distance

➩ Turn the eyelenses on the eyepieces to "0" or set the dioptric

settings, if known.

➩ Set the magnification changer to step 10.
➩ Look through the eyepieces and adjust the tubes by hand

(for binocular tubes without drive knobs) or using the drive
knob (1) until you see a concentrically circular image field.

Set the interpupillary distance and
eyepoint

Adjust for parfocality

1

Adjusting the dioptric settings

Adjust the dioptric settings accurately for each eye separately;
only this method will ensure that the image will stay in
focus throughout the entire zoom 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.

➩ Engage the highest brightness.
➩ Engage the lowest magnification.
➩ Displace the microscope so that the test object is visible in

the center of the field of view.

2. Focus on the test object

➩ Engage the highest magnification.
➩ Bring the test object into focus.
➩ Engage the lowest magnification.

3. Adjust the dioptric settings

➩ Adjust the dioptric settings for each eye in turn (2), so that

the image is seen in sharp focus.

➩ Engage the highest magnification.
➩ Refocus using motor-driven focusing.
➩ Engage the lowest magnification.
➩ Inspect the dioptric settings, readjusting them if necessary

so that both images are sharp.

4. Inspect the parfocality

➩ Zoom through the whole range, observing the test object.

The image sharpness must remain constant at all magnifica­tions. If it does not, then repeat points 2 to 4 of this proce­dure.

+5 -5 +5 -5

2

13Leica M501 / Ref. 10 711 785 / Version D

Preparation for Operation

Attach the adapter for accessories

Beam splitter with 50/50% observance

Stereo adapter for accessories

Adapter for Zeiss accessories on the Leica M501

Adapter for M600 accessories for the Leica M501

1

Attach the beam splitter/stereo adapter

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

Attach the adapter

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

14 Leica M501 / Ref. 10 711 785 / Version D

Preparation for Operation

Stereo attachment for second observer

The dual stereo attachments can be attached to the left or right
on the beam splitter and turned in any direction.

Tubes for second observer

The assistant turns the monocular tube for second observer in
the desired direction, adjusts his or her diopter on the eyepiece
and centers the image using the knurled ring.

Stereo attachment for second observer

The assistant turns his or her diopters in the desired direction,
centers the binocular tube horizontally, adjusts his or her
diopters and centers the image using the knurled ring.

Attach the stereo attachment/tube for second observer.

➩ Feed the stereo attachment/tube for second observer into

the beam splitter,

➩ Tighten the rotary ring (1).

1

Adjusting second-observer tube

15Leica M501 / Ref. 10 711 785 / Version D

Preparation for Operation

Display/change the footswitch type

You can choose between cross pedal or vertical pedal variants
for the footswitch.

Display the footswitch type:
➩ Press the brightness regulating knob (3) for approx. 5 sec-

onds and release it.

The display bar (4) displays a small light for about three sec-

onds beneath the symbol (2) of the footswitch variant that is

currently selected

( or ).
Change the footswitch type:
➩ While the footswitch type is displayed (see above), briefly

press the brightness regulating knob.

This switches to the other footswitch variant and the type

that is now enabled is displayed for about 3 seconds.

Switch the + and – movement directions of the XY-unit (figure 1)

1

2

Use the "XY-Reverse" button (1) on the footswitch to reverse the
+ and – movement directions for the XY-unit to – and +.
➩ Press button (1), the small light (2) next to the zoom

indication (Figure 3) turns on.
➩ Pressing button (1) again reverses the XY function back to

normal and the small light (2) turns off.

This requires that this function is enabled (see below).

Disable/enable the function of the XY-Reverse button (figures 1 and 2)

To prevent this function from being triggered inadvertently, the
"XY-Reverse" button can be disabled.
Disable the function of the "XY-Reverse" button:
➩ Switch off the control unit/lamp housing at the power

switch (3).

➩ Press and hold button (1) of the footswitch.
➩ Switch on the control unit/lamp housing at the power switch

(3) and release button (1).

The "XY-Reverse" button is now disabled.
Enable the XY-Reverse button:

➩ Repeat the above steps.

2

•

XY-Reverse

3

43

2

-X

+Y

+X

+X

-Y

-X

-Y

+Y

1

1

3

16 Leica M501 / Ref. 10 711 785 / Version D

Preparation for Operation

Caution 3
Surgical microscope can move without warning!

➩Always lock the footbrakes when you are not moving

the system.

Caution 2
The swinging arm can swing out uncontrollably!

➩Before transport, always set the instrument to the

transport configuration.

Transport position

Lock the swing arm:

➩ Position the swing arm approximately horizontally.
➩ Pull out the retaining pin (1).
➩ Move the swing arm slightly up and down until the safety

hook (2) engages.
The swing arm is now locked.
➩ Release the articulation brakes (3) and fold up the swing

arm.
➩ Set the surgical microscope in its transport position and lock

the articulation brakes.

Caution 4
Feet in lightweight shoes could become trapped
beneath the casing of the base!

➩Always push the instrument to displace it; never pull it.

Transport the surgical microscope and secure it in its setup
position

➩ Pull the power cable out of the socket.
➩ Step on the footbrake release lever (5) to release the foot-

brakes (6).
➩ Push the surgical microscope to its setup position using the

handle (4).
➩ Lock the footbrakes at the setup position.

Transport the surgical microscope

(floor stand only)

56

6

3

3

4

2

1

17Leica M501 / Ref. 10 711 785 / Version D

Preparation for Operation

➩ Using the handle, transport the surgical microscope to the OP

stage and position it as needed for the operation.

➩Apply footbrake.
➩

Connect the power cable to the control unit/lamp housing (13).

➩ Connect the potential equalization to the control unit/lamp

housing (9).

➩ Connect the foot or handswitch to the control unit/lamp

housing (11).
CAN-Bus interface (10).
Service interface socket (12).

Optional Leica Telescope Mount

Position the surgical microscope at the
OP stage

Warning 5
Danger of fatal electrical shock!

➩Plug the surgical microscope only into a grounded

socket.

Caution 9
Danger of collision!
The surgical microscope can collide with nearby com­ponents, light fixtures, or the ceiling.

➩Check the danger area before moving the swing arm.
➩Move the ceiling mount upwards carefully, and note

the position of the ceiling and light fixtures.

Warning 8
Risk of injury from the surgical microscope being
lowered!

➩Never position the surgical microscope over the

patient while it is moving downwards.

➩To avoid collisions, watch the surgical microscope

while it is being lowered.

Move the telescope arm to the desired height:
➩ Press the button (1).

 Raise the telescope arm
 Lower the telescope arm

In continuous operation, the telescope may be oper­ated for a maximum of 1 minute out of every 10.
After 2 minutes of uninterrupted operation, the built-in
temperature switch switches off the motor of the
Leica Telescope Mount.

1211109

13

1

18 Leica M501 / Ref. 10 711 785 / Version D

Setting the rest position on the Leica Telescope Mount

➩ Swing the microscope away.
➩ Remove the sterile components.
➩ Switch off the power switch.
➩ Move the swing arm all the way upwards.
➩ Release the articulation brakes.
➩ Press the raise lift arm  (2) button.

The Leica Telescope Mount moves upwards.

2

Caution 9
Danger of collision!
The surgical microscope can collide with nearby com­ponents, light fixtures, or the ceiling.

➩Check the danger area before moving the swing arm.
➩Move the ceiling mount upwards carefully, and note

the position of the ceiling and light fixtures.

Preparation for Operation

Attach the sterile components

Set for one operation

• 3 handles

• 3 drive knobs

The handles and drive knobs can be sterilized via steam or gas.

➩ Sterilize the handles and drive knobs.
➩ Place the sterile drive knobs onto the binocular tube and the

turn knob for fading ambient lighting.
➩ Place the sterile handles onto the optics carrier and the tilt

head.

1

1

1

1

➩ Adjust the tilt of the footswitch. Screw the adjustable sup-

ports in or out.
➩ Check that all accessories are correctly connected and

securely attached.
➩ Release the articulation brakes and apply them lightly.

Make the joint easier to move:
➩ Release the joint brake (1).
Make the joint stiffer:

➩ Tighten the joint brake (1).

➩ Extend the swinging arm.
➩ Release the retaining hook on the swinging arm.
➩ Check the weight setting on the swinging arm by raising and

lowering the microscope and correct as necessary.

Caution 7
Danger of infection!

➩Leave sufficient space around the stand to ensure

that the sterile drape does not come into contact with
non-sterile components.

19Leica M501 / Ref. 10 711 785 / Version D

Preparation before operation/Use

Operating the surgical microscope

1

➩ Switch on the power switch (1).

The XY-unit is driven to its middle position.
When the middle position is reached, the LED lights up.

The focus is driven at maximum speed to its home position
(1/3 up, 2/3 down). When the focus reset position is reached,
the LED lights up.

Basic settings:

When the Leica M501 is switched on at the power switch,
the zoom finds the position it was in when the unit was last
switched off.

The illumination for the surgical microscope turns on.

Setting the rest position on the Leica Mini Mount

➩ Swing the microscope away.
➩ Remove the sterile components.
➩ Switch off the power switch.
➩ Move the swing arm all the way upwards.
➩Swing the device out of the working area.
➩Tighten the articulation brakes.

Caution 10
Danger of collision!
The surgical microscope can collide with nearby com­ponents.

➩Check the danger area before moving the swing arm.

20 Leica M501 / Ref. 10 711 785 / Version D

Use

Basic settings:

➩ Press the "Reset Focus" (2) button. The focus is driven at

maximum speed to its home position (1/3 up, 2/3 down).
When the focus reset position is reached, the LED (1) lights up.

Adjusting the focus

➩ Activate the button (9) on the foot or hand switch.
➩ Adjust the speed using the regulating knob (12) on the con-

trol unit/lamp housing.

11

12
13

Adjusting the focus

Adjusting the magnification

➩ Activate the button (10) on the foot or hand switch.
➩ Adjust the speed using the regulating knob (13) on the

control unit/lamp housing.

Position the microscope

8

9

8

9

10

10

Set the middle position:

➩ Press the "Reset X/Y-unit" key (3).

The XY-unit is driven to its middle position.
When the middle position is reached, the LED (4) lights up.

Coarse positioning

➩ Hold the microscope by the two handles (5) and position it.

Fine positioning

➩ Use foot or hand switch (8) to activate X/Y-unit.
➩ Adjust the travel speed of the XY-unit using the regulating

knob (11) on the control unit/lamp housing.

Rough tilt adjustment:

➩ Release the brake knob (7) and roughly adjust the tilt of the

microscope.

➩ Tighten the brake knob (7).

Fine tilt adjustment:

➩ Use the tilt fine adjustment (6) to accurately adjust the tilt of

the microscope.

1
2

3

4

6

5

21Leica M501 / Ref. 10 711 785 / Version D

Use

➩ Adjust the brightness of the main illuminator using the regu-

lating knob (6) or the hand or footswitch. (1) = brighter,
(2) = darker. The brightness level is displayed on the display
bar (5).

➩ Turn the filter knob (4) until the correct filter is selected.

4

7

8

Adjusting the illumination

Setting the illumination type and the
working distance

➩ Adjust the approximate working distance by raising or

lowering the microscope using the handles (8).

➩ Turn counterclockwise (7) to fade out ambient lighting/6°

➛ Red reflex illumination/0° remains.

1 2

3

Switching microscope illumination on and off

Use button (3) to switch microscope illumination on and off.

Warning 6
Intensive light can injure eyes!

Light that is too intense can damage the retina, so
please:
➩Select short illumination times and low brightness

settings.

Warning 12
Protect the eyes of your patients!

➩The GG475 UV protection filter must be used to pro-

vide protection against light damage when using the
surgical microscope in ophthalmology.

56

22 Leica M501 / Ref. 10 711 785 / Version D

Safety Notes

The Leica surgical microscope meets today’s state of the art of
technology. Nevertheless, hazards can occur during operation.
➩ For this reason, always observe the information in this User

Manual, especially the Safety Notes.

Intended use

• The Leica surgical microscope system is an optical instru­ment which uses magnification and illumination to improve
the display of objects. It can be applied for observation and
documentation and for human and veterinary medical treat­ment.

• The Leica surgical microscope may be used only in closed
rooms and must be placed on a solid floor or attached to a
strong ceiling or wall.

• The Leica M501 surgical microscope is subject to special
precautionary measures for electromagnetic compatibility.
It must be installed and put into operation in accordance
with the guidelines, manufacturer's declarations and
recommended safety distances (Table 201, 202, 204, 206
according to EN 60601-1-2:2001).

• Portable and mobile as well as stationary RF communica­tions equipment can have a negative effect on the reliability
of the Leica M501 surgical microscope.

Directions for the operator of the
instrument

➩ Ensure that the surgical microscope is used only by persons

qualified to do so.

➩ Ensure that this user manual is always available at the place

where the surgical microscope is in use.

➩ Carry out regular inspections to make certain that the autho-

rized users are adhering to safety requirements.

➩ When instructing new users, do so thoroughly and explain

the meanings of the warning signs and messages.

➩ Assign individual responsibilities for starting, operating and

servicing the Leica Surgical Microscope and monitor the
observance of these responsibilities.

➩ Only use the surgical microscope if it is free of defects.
➩ Inform your Leica representative or Leica Microsystems

(Schweiz) AG, BU SOM, CH-9435 Heerbrugg, immediately if
you detect a product defect that could potentially cause
injury or harm.

➩ If you use accessories made by third-party manufacturers

with the Leica Surgical Microscope, be sure that each such
manufacturer confirms the safety-engineering, harmless
usability of the product and observe the product’s user
manual.

➩ Modifications to or service on the surgical microscope may

be carried out only by technicians who are explicitly autho­rized by Leica to do so.

➩ Only original Leica replacement parts may be used in servic-

ing the product.

➩ After service work or technical modifications, the unit must

be reconfigured with observance to our technical require­ments.

➩ If the unit is modified or serviced by unauthorized persons, is

improperly maintained (as long as maintenance was not car­ried out by us), or is handled improperly, Leica will not
accept any liability.

➩ The influence on other devices by the Leica Surgical Micro-

scope has been tested in accordance with EN 60 601-1-2.
The system passed emissions and immunity test. Here, the
standard preventive measures and safety regulations per­taining to electromagnetic and other radiation had to be
observed.

Directions for the user of the instrument

➩ Follow the instructions described here.
➩ Follow the instructions given by your employer regarding the

organization of work and safety at work.

Guidance and manufacturer’s declaration

23

Leica M501 / Ref. 10 711 785 / Version D

Manufacturer’s declaration of electromagnetic compatibility (EMC)

This "Guidance and manufacturer’s declaration" document is based on EN 60601-1-2:2001.

Table 201 from EN 60601-1-2:2001

Guidance and manufacturer’s declaration – electromagnetic emissions

The Leica M501 surgical microscope is intended for use in the electromagnetic environment specified below.
The customer or the user of the Leica M501 surgical microscope should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions Group 1 The Leica M501 uses RF energy only for its internal function.
according to CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any

interference in nearby electronic equipment.

RF emissions Class A The Leica M501 is suitable for use in establishments
according to CISPR 11 other than domestic and those directly connected to the public

low-voltage power supply network that supplies buildings used for
domestic purposes.

Harmonic Class A
emissions
IEC 61000-3-2

Voltage fluctuations/ according
flicker emissions
IEC 61000-3-3

Guidance and manufacturer’s declaration

24

Leica M501 / Ref. 10 711 785 / Version D

Table 202 from EN 60601-1-2:2001

Guidance and manufacturer’s declaration – electromagnetic immunity

The Leica M501 surgical microscope is intended for use in the electromagnetic environment specified below.
The customer or the user of the Leica M501 surgical microscope should assure that it is used in
such an environment.

Immunity test IEC 60601 test level Compliance level

Electrostatic ± 6 kV ± 6 kV
discharge (ESD) contact contact
IEC 61000-4-2

± 8 kV air ± 8 kV air

Electrical fast ± 2 kV for ± 2 kV for
transient/ power supply lines power supply lines
burst
IEC 61000-4-4 ± 1 kV for input/ ± 1 kV for input/

output lines output lines

Surge ± 1 kV ± 1 kV
IEC 61000-4-5 differential mode differential mode

± 2 kV ± 2 kV
common mode common mode

Voltage dips, <5% UT (>95% <5% UT (>95%
short interruptions dip in UT) dip in UT)
and voltage variations on for 11/22cycle for 11/22cycle
power supply lines
IEC 61000-4-11 40% UT (60% 40% UT (60%

dip in UT) dip in UT)
for 5 cycles for 5 cycles

70% UT (30% 70% UT (30%
dip in UT) dip in UT)
for 25 cycles for 25 cycles

< 5% UT (>95% < 5% UT (>95%
dip in UT) dip in UT)
for 5 sec. for 5 sec.

Power frequency 3 A/m Not applicable
(50/60 Hz)
magnetic field
IEC 61000-4-8

Note: UT is the a.c. mains voltage prior to application of the test level.

Electromagnetic environment – guidance

Floors should be of wood, concrete or
ceramic tile. If floors are covered with syn­thetic material, the relative humidity should
be at least 30%.

Mains power quality should be that of a
typical commercial or hospital environ­ment.

Mains power quality should be that of a
typical commercial or hospital environ­ment.

Mains power quality should be that of a
typical commercial or hospital environ­ment. If the user of the Leica M501 surgical
microscope requires continued operation
during power mains interruptions,
it is recommended that the Leica M501
surgical microscope be powered from an
uninterruptible power supply or a battery.

Guidance and manufacturer’s declaration

25

Leica M501 / Ref. 10 711 785 / Version D

Table 204 from EN 60601-1-2:2001

Guidance and manufacturer’s declaration – electromagnetic immunity

The Leica M501 surgical microscope is intended for use in the electromagnetic environment specified below.
The customer or the user of the Leica M501 surgical microscope should assure that it is used in
such an environment.

Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance

Portable and mobile RF communications
should be used no closer to any part of the
Leica M501 surgical microscope, including
cables, than the recommended separation
distance calculated from the equation applic­able to the frequency of the transmitter.

Recommended separation distance:

Conducted RF 3 Vrms 3 Vrms d = 2.4 P
equipment 150 kHz to 80 MHz 150 kHz to 80 MHz
IEC 61000-4-6

Radiated HF 3 V/m 3 V/m d = 2.4 P

80 MHz to 2.5 GHz

IEC 61000-4-6 80 MHz to 2.5 GHz

Where Pis the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in
meters (m). Field strengths from fixed RF
transmitters, as determined by an electro­magnetic site survey, should be less than the
compliance level in each frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:

Note 1: At 80 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,

amateur radio, AM and FM broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the elec­tromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the Leica M501 surgical microscope is used exceeds the applicable RF compliance level
above, the Leica M501 should be observed to verify normal operation. If abnormal performance is observed, additional
measures may be necessary, such as reorienting or relocating the Leica M501.

b Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

Guidance and manufacturer’s declaration

26

Leica M501 / Ref. 10 711 785 / Version D

Table 206 from EN 60601-1-2:2001

Recommended separation distances between portable and mobile RF telecommunications equipment and
the Leica M501 surgical microscope

The Leica M501 surgical microscope is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or user of the Leica M501 surgical microscope can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF communication
equipment (transmitters) and the Leica M501 as recommended below, according to the maximum output power of the
communications equipment.

Separation distance according to frequency of transmitter in m

Rated maximum output 150 kHz to 2.5 GHz
power of transmitter W

d = 2.4 P in m

0.01 0.24

0.1 0.8

1 2.4

10 8.0

100 24.0

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output powerrating
of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

Warning message:

Using accessories or cables other than those listed here or those permitted by the manufacturer of the Leica M501
surgical microscope may result in increased electromagnetic emissions or decreased immunity.

Warning message:

The Leica M501 surgical microscope may not be used while positioned directly next to other instruments.
If it is necessary to operate it in the vicinity of other instruments, the instrument should be monitored to ensure that it functions
properly in this arrangement.

27Leica M501 / Ref. 10 711 785 / Version D

Safety Notes

Caution 3
Surgical microscope can roll away on its own!

➩Always lock the footbrakes when you are not moving

the system.

Caution 4
Feet in lightweight shoes could become trapped
beneath the casing of the base!

➩

Always push the instrument to displace it; never pull it.

Warning 5
Danger of fatal electrical shock!

➩Plug the surgical microscope only into a grounded

socket.

Caution 13
Burn hazard!

The lamp for the emergency illuminator can become
very hot.
➩Before changing lamps, ensure that the lamp has

cooled down.

Caution 14
You may sustain burns!

Lamps and mounts for holding illumination devices can
become very hot.
➩Before changing lamps, ensure that the lamp and the

mount have cooled down.

Caution 7
Danger of infection!

➩Leave sufficient space around the stand to ensure

that the sterile drape does not come into contact with
non-sterile components.

Warning 1
Risk of injury from the surgical microscope swinging
down!

➩Never rebalance or re-equip with the instrument over

the field of operation.

➩After re-equipping, always rebalance the swinging

arm.

Caution 2
The swinging arm can swing out uncontrollably!

➩Before transport, always set the instrument to the

transport configuration.

Warning 6
Intensive light can injure eyes!

Light that is too intense can damage the retina, so
please:
➩Select short illumination times and low brightness

settings.

Hazards associated with instrument use

Caution 10
Danger of collision!
The surgical microscope can collide with nearby
components.

➩Check the danger area before moving the swing arm.

Warning 11
Danger of fatal electrical shock!

➩Always unplug the power cable from the unit supply

socket before changing the fuse.

Warning 12
Protect the eyes of your patients!

➩The GG475 UV protection filter must be used to pro-

vide protection against light damage when using the
surgical microscope in ophthalmology.

Caution 9
Danger of collision!
The surgical microscope can collide with nearby
components, light fixtures, or the ceiling.

➩Check the danger area before moving the swing arm.
➩Move the ceiling mount upwards carefully, and note

the position of the ceiling and light fixtures.

Warning 8
Risk of injury from the surgical microscope being
lowered!

➩Never position the surgical microscope over the

patient while it is moving downwards.

➩To avoid collisions, watch the surgical microscope

while it is being lowered.

28 Leica M501 / Ref. 10 711 785 / Version D

Safety Notes

Grounding reliability can

only be achieved when
EQUIPMENT is connected to
equivalent receptacle marked
"Hospital" or "Hospital Grade".

Leica Microsystems AG
CH-9435 Heerbrugg

MODEL LEICA M501

100V – 240V~ 50/60Hz

400VA

Form 2x T8.3A / 250V

Signs and labels

Type 10446644
S/N XXXXXXXXX

Caution 9

To prevent electric shock, do not remove cover.
No user serviceable parts inside.
Refer servicing to qualified service personnel only.

29Leica M501 / Ref. 10 711 785 / Version D

Safety Notes

DO NOT OPEN AND
DAMAGE-HIGH PRESSURE!
GAS SPRING 10710287

Warning:

This system may only be used
with the gas spring 10710287
otherwise the instrument can fall over.

30 Leica M501 / Ref. 10 711 785 / Version D

Safety Notes

Caution 1

You may sustain burns!
Mounts for the main illuminator can become very hot.

➩ Before changing lamps, ensure that the mount has cooled down.

31Leica M501 / Ref. 10 711 785 / Version D

Safety Notes

Leica Microsystems AG
CH-9435 Heerbrugg

MODEL LEICA M501

230V~ 50 Hz

1400VA

S/N TTMMJJxxx - C

Leica Microsystems AG
CH-9435 Heerbrugg

MODEL LEICA M501

120V~ 60 Hz

1500VA

S/N TTMMJJxxx - C

Only one of the two signs, depending on
the power supply voltage.

32 Leica M501 / Ref. 10 711 785 / Version D

Care and Maintenance

• Put a dust cover over the instrument during breaks in work.

• Keep accessories in a dust-free place when not in use.

• Remove dust with a pneumatic rubber pump and a soft
brush.

• Clean the objectives and eyepieces with special optics
cleaning cloths and pure alcohol.

• Protect the surgical microscope from moisture, fumes and
acids and from alkaline, caustic and corrosive materials.
Do not keep chemicals near the instrument.

• Protect the surgical microscope from improper handling.
Never install any other socket or unscrew the optical sys­tems or mechanical parts unless expressly instructed to do
so in the instructions.

• Protect the surgical microscope from oil and grease.
Never oil or grease the guide surfaces or mechanical parts.

• Remove coarse debris with a moistened disposable cloth.

• To disinfect the surgical microscope, use preparations from
the group of surface disinfectants based on the following
substances:

- aldehyde,

- alcohol,

- quaternary

ammonia compounds.

The device is basically maintenance-free. To keep it reliable,
we recommend that you visually inspect the product for dam­age once a year and, as necessary, contact your service orga­nization.

The ceiling mount must be serviced and maintained at certain
intervals.

Regularly, but at least once every 6 months

• Functional and visual inspection of the entire ceiling mount
by an authorized specialist.

Every 6 years

• Visual inspection of all cables by authorized professionals.

Every 12 years

• Thorough restoration and replacement of the cables.

Use only original spare parts for servicing.

Because they can potentially cause damage to materi­als, substances based on the following are not suited
for use with the system:

• halogen-separating compounds,

• strong organic acids,

• oxygen-separating compounds.

Follow the disinfectant manufacturer’s instructions.

It is recommended to conclude a service contract with
Leica Service.

1

1

2

3

▼

2 3

Warning 11
Danger of fatal electrical shock!

➩Always unplug the power cable from the unit supply

socket before changing the fuse.

➩The fuses are located in a fuse holder in the device power

socket (1, Figure 1).

➩Use a screwdriver (2, Figure 2) to press the fuse holder

(3, Figure 2) out in the direction indicated by the arrow, pull
it out completely by hand (Figure 3) and change the fuses.

➩Insert the fuse holder again and push it all the way in by

hand.

Changing the fuse

33Leica M501 / Ref. 10 711 785 / Version D

Care and Maintenance

Changing bulb

1

36

Caution 13

You may sustain burns!

Lamps and mounts for holding illumination devices can become
very hot.
➩ Before changing lamps, ensure that the lamp and the mount

have cooled down.

To ensure that a replacement lamp is always available
should a bulb burn out, always replace defective bulbs
immediately after the operation.

➩ Turn the turn grip for the quick-change lamp mount (1) 30° to

the "Change Bulb" position and pull it out.
This automatically switches off the illumination.

➩ Pull the halogen lamp (4) and its mount (5) out of the holder

(2) (Figure 2).

➩ Put a new halogen lamp into the mount.

➩ Push the halogen lamp with the mount into the holder until

you feel it snap into place.

➩ Push the turn grip for the quick-change lamp back into the

housing.
The nib (6) on the turn grip for the quick-change lamp mount
has to be inserted into the notch (3) in the housing.

➩ Turn the turn grip for the quick-change lamp mount to the

lamp symbol ( ).
This automatically switches illumination back on.

1

2

3

Illumination

➩ Switch on the main power switch. The main illuminator

switches on.

➩ Switch to auxiliary illumination.

Auxiliary illumination lights up.

➩ Switch back to the main illuminator and switch illumination

off.

Foot/hand switch

➩ Position the foot and hand switches.
➩ Test all foot and hand switch functions.

Inspecting the functioning

2

3

4

5

34 Leica M501 / Ref. 10 711 785 / Version D

Care and Maintenance

Notes on reprocessing of resterilizable
products

Products

Reusable products supplied by Leica Microsystems (Schweiz)
AG such as rotary knobs, objective protective glasses and cap­ping pieces.

Occupational safety and health protection

Particular attention must be paid to the occupational safety and
health protection of the persons responsible for preparing cont­aminated products. Current regulations of hospital hygiene and
prevention of infection must be observed in the preparation,
cleaning and disinfection of the products.

Limitation of reprocessing

Frequent reprocessing has little effects on these products.
The end of the product life cycle is usually determined by wear
and year and damage through use.

Instructions

Workplace

Remove surface contamination with a disposable cloth/paper
cloth.

Storage and transport

No special requirements.
It is recommended to perform the reprocessing of a product
immediately following its use.

Preparation for cleaning

Remove the product from the surgical microscope.

Cleaning: manual

Equipment: running water, rinsing agent, spirit, micro-fiber cloth
Procedure:

1.

Rinse surface contamination off of the product (temp. < 40 °C).
Use some rinsing agent depending upon degree of contamina­tion.

2. If the optics is heavily contaminated, e.g. finger marks, fat
streaks, etc., use spirit for cleaning.

3. Dry off products, except for optical components, with a dis­posable cloth/paper cloth. Dry off optical surfaces with a
micro-fiber cloth.

Cleaning: automatic

Equipment: Cleaning/disinfecting device
It is not recommended to clean products with optical compo­nents in a cleaning/disinfecting device. In addition, optical
components must not be cleaned in ultrasonic baths in order
to prevent damage.

Disinfection

The alcohol disinfection solution "Mikrozid, Liquid" may be used
in accordance with the instructions on the label.
Please note that optical surfaces must be rinsed thoroughly
with fresh drinking water, followed by fresh demineralized
water, after disinfection. The products must be dried thoroughly
before the subsequent sterilization.

Maintenance

No special requirements.

Control and functional test

Check the snap-on behavior of rotary knobs and handles.

Packaging

Separate: A standard PE bag may be used. The bag must be
large enough for the product so that the closure is not under
tension.

Sterilization

See Table 1

Storage

No special requirements.

Additional information

None

Contact information of manufacturer

Address of local agent

Leica Microsystems (Schweiz) AG verified that the aforemen­tioned instructions for the preparation of a product are suitable
for its reuse. The processing person is responsible for repro­cessing with the equipment, materials and personnel and for
achieving the desired results in the reprocessing installation. In
general, this requires validations and routine monitoring of the
process. Every deviation from the supplied instructions should
also be examined carefully by the processing person to deter­mine effectiveness and possible detrimental consequences.

35Leica M501 / Ref. 10 711 785 / Version D

Care and Maintenance

Table 1: Sterilization

Permissible sterilization methods
Item Steam (autoclave) Ethylene oxide
number Designation 134 °C, t > 10 min. max. 60 °C
10180591 Clip-on handle X
10428328 Rotary knob, binoc. tube T X
10384656 Rotary knob, transparent X
10443792 Lever extension X
10429792 Capping piece, slit illuminator X
10445368 Cover, binoc. tube 0–180° X
10445289 Handswitch holder X

10446058 Protective glass, multifoc. obj. X

1)

10446469 Objective protective glass Leica M680 X

1)

10446467 Objective protective glass Leica M840/M841 X

1)

10443714 Rotary ring, objective 0° X
10445341 Handle for Leica M655, sterilizable X
10445549 Handle for Leica M695 X
10445340 Cap for Leica M655/M695, sterilizable X

1)

Products with optical components can be steam-autoclaved using the conditions listed above.
However, this may lead to the formation of a layer of dots and streaks on the glass surface,
which may reduce the optical performance.

36 Leica M501 / Ref. 10 711 785 / Version D

Messages and Warnings

Ventilation

There are two fans in the control unit/lamp housing:
– illumination fan
– power pack fan
If either of the two fans fails, the display bar (1) blinks. If the illu­mination fan fails, the brightness of the light decreases.

1

If the device does not function faultlessly, please con­tact your Leica representative.

General malfunctions

Failure

The swing arm rises and sinks by itself.

The swing arm lowers even when the
balance scale is set to its highest level.

The microscope cannot be moved, or
great force is required to move it.

The functions cannot be activated with
the hand-/footswitch.

There is no light in the microscope.

The image goes out of focus.

The illumination brightness decreases
suddenly and the display bar for the
brightness level blinks.

The display bar for the brightness level
blinks but the light brightness remains
the same.

Cause

The swinging arm is not correctly
balanced.

The total weight of microscope and
accessories is too high.

The articulation brakes are applied too
strongly.

The cable connection has loosened.

The connection for the fibre-optic light
guide has loosened.

Defective lamp.

Illumination changer not engaged in
position.

Eyepieces not seated properly.

Diopters not set correctly.

Illumination fan defective.

Power pack fan defective.

Remedy

➩ Balance the swing arm (see page 9).

➩ Reduce the total weight.

➩ Loosen the articulation brakes

(see page 18).

➩ Check the main power cable.
➩ Check the foot/handswitch

connection.

➩ Check the fibre-optic light guide

connections.

➩ Check the lamps and replace as nec-

essary.

➩ Turn the illumination changer until it

engages in its rest position at the lamp
symbol ( ).

➩ Screw the eyepieces all the way on.

➩ Adjust your dioptric settings exactly

as described.

➩ Have the fan replaced.

➩ Have the fan replaced.

37Leica M501 / Ref. 10 711 785 / Version D

Fault Cause Remedy

Telescope cannot move up The telescope motor is protected by ➩ Wait approx. 30–45 minutes for
or down. a temperature switch and the telescope motor to cool off.

switches off in case of overheating.

No power supply voltage present. ➩ Check the power supply voltage.

Poor plug contact. ➩ Check the clamping terminal.

➩ Check the plug of the handgrip.

Defective power cable. ➩ Replace the power cable.

Customer-side fuse defective. ➩ Replace the fuse.

The up/down movement of the Handswitch is defective. ➩ Detach the handswitch from
telescope cannot be stopped. the telescope.

Electrical data

Power supply

- Floor stand Centrally located on the control unit; 100–240 VAC (±10 %); 50/60 Hz

- Leica Mini Mount Terminal block on the cover; 100–240 VAC (±10 %); 50/60 Hz

- Leica Telescope Mount Terminal block on the cover; 100/120 VAC, 220/240 VAC (±10 %); 50/60 Hz
Protection class Class 1
Safety type Type B
Fuse T 6.3A H, 250V
Power consumption - Leica M501 surgical microscope: 400 VA

- Leica Telescope Mount 110/120 V: 1091 VA

- Leica Telescope Mount 220/234 V: 943 VA

Microscope

Magnification changer Zoom 6:1, motorized, adjustable speed

Focus Motorized, 45mm, adjustable speed, automatic reset at power on

Button-operated reset option

Tilt ±5° manual fine adjustment; +20°/–15° manual rough adjustment

Objectives APO WD = 175mm

f = 175mm
f = 200mm
f = 225mm

Eyepieces Wide-field eyepieces for spectacle wearers, 10x (optional 12.5)

Diopter adjustment ±5 diopters with adjustable eyecups

Illumination Homogenous ambient illumination Ø 47mm

Adjustable brightness
Ambient illumination can be blocked out
IR protective filter firmly integrated
Integrated UV protection filter KV408
UV protective filter GG475 on/off switchable, integrated

Messages and warnings/Technical data

38 Leica M501 / Ref. 10 711 785 / Version D

Technical data

Analog

XY-unit 40mm movement range each in X and Y directions

Adjustable speed
Automatic reset at power on
Button-operated reset option

CAN-bus interface With 24 VDC/50 W power output

Control unit/lamp housing Connection jacks for

- Fibre-optic cables

- Power cable

- Foot/handswitch

- Zero-potential adjustment

- CAN-bus interface with 24 VDC/50 W power output

- Service interface RS 232
Display for brightness
Quick-change lamp mount with 2 21 V/150 W halogen lamps, type EJA
Filter changer with UV protection filter
Integrated sequence connectable GG475
Two free openings for connectable Ø 12mm filter
Control elements:

- Power switch

- Adjusters for brightness and zoom,

XY and focus speed

Weight 15kg (with accessories)

Stands

Floor stand

Guide rollers 4 x
Weight Base 100kg

Column 22kg

Brakes Two integrated friction brakes

5.0x - 30.1x

4.0x - 24.1x

42.4 - 7.1

52.4 - 8.7

Eyepiece

10x

12.5x

Objective

WD = 175mm/f = 200mm

Total magnification Field of view ø

3.5x - 20.8x 60.6 - 10.1

4.3x - 26x 49 - 8.2

Eyepiece

10x

12.5x

Objective

f = 225mm

Total magnification Field of view ø

3.1x - 18.7x 67.5 - 11.2

3.9x - 23.3x 54.7 - 9.1

Eyepiece

10x

12.5x

Objective

f = 175mm

Total magnification Field of view ø

39Leica M501 / Ref. 10 711 785 / Version D

Technical data

Leica Mini Mount

Ceiling attachment Max. distance from concrete ceiling to intermediate ceiling: 1200mm

Attachment to concrete shell construction ceiling: 440mm hole circle

4 x M12 HSLB M12/25
Rotation range 330° (secured with rope)
Weight Mounting bracket 50kg

Column max. 55kg

(at max. tube length)

Leica Telescope Mount

Ceiling attachment Max. distance from concrete ceiling to intermediate ceiling: 1200mm

Attachment to concrete shell construction ceiling: 440mm hole circle

4 x M12 HSLB M12/25
Rotation range 330°
Weight Approx. 146kg
Projection 1186mm
Vertical stroke 500mm

Swing arm

Floor stand, Leica Mini Mount and Leica Telescope Mount

Brakes • three mechanical articulation brakes

• one lock lever for vertical movement
Load Max. 5.4kg from microscope/dovetail ring interface
Balancing Via gas spring
Weight 22kg
Projection 1186mm
Stroke 600mm

Ambient conditions

Use +10 °C to +40 °C, +50 °F to +104 °F

30% to 95% relative humidity

Storage –40 °C to +70 °C, -40 °F to +158 °F

10% to 100% relative humidity

Limitations of use

The Leica Surgical Microscope may be used only in closed rooms and must be placed on a solid floor
or attached to a strong ceiling or wall.

Standards

IEC 60601, UL 2601

40 Leica M501 / Ref. 10 711 785 / Version D

Technical data

Floor stand (in mm)

Dimensions

1850

1520

1186

760–1340

Leica Mini Mount (in mm)

1850

1186

670 850

1520

760–1340

41Leica M501 / Ref. 10 711 785 / Version D

Technical data

Leica Telescope Mount (in mm)

Leica Microsystems (Schweiz) AG
Business Unit SOM
Max Schmidheiny-Strasse 201
CH-9435 Heerbrugg

Telephone [phone]
Fax [phone]
www.leica-microsystems.com
www.surgicalscopes.com

Illustrations, descriptions and technical data are not binding and may be changed without notice.

© Leica Microsystems (Schweiz) AG • CH-9435 Heerbrugg, 2005

Art. No. 10 711 785 – Version D – Printed in Switzerland – en –VI.2005 – RDV

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