Leica M320 User Manual

MEDICAL DIVISION

Leica M320

User Manual

10 718 878 - Version 01

Thank you

for deciding in favor of a Leica surgical microscope system. For valuable information about
Leica Microsystems produc ts and services and the address of your nearest Leica
representative, please visit our website:

www.leica-microsystems.com

Leica Microsystems (Schweiz) AG
Medical Division
Max Schmidheiny-Strasse 201
CH-9435 Heerbrugg
Phone: [phone]
Fax: [phone]

Product identication

The model code and serial number of your product are provided on the nameplate found on
the underside of the control unit. Copy this information to the line below so that it is handy in
case you have questions for our representatives or service locations.

Type: Serial number:

Leica M320 / Ref. 10 718 878 / Version 01

CONTENTS

1 INTRODUCTION ..................................................................1

1.1 Basics .......................................................................1

1.2 Intended use ................................................................1

1.3 Symbols .....................................................................1

1.4 Required tools ...............................................................1

2 INSTRUCTIONS ...................................................................2

2.1 User proles .................................................................2

2.2 Safety notes .................................................................2

2.3 Directions for the operator of the instrument .................................3

2.4 Disposal .....................................................................3

3 CONTROLS .......................................................................4

3.1 Stan ds. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

3.2 Swing arm and horizontal arm ...............................................5

3.3 Optics carrier ................................................................6

3.4 Microscope carrier ...........................................................6

3.5 Brake knobs/articulation brakes ..............................................7

3.6 Connections .................................................................8

4 ACCESSORIES .....................................................................9

4.1 Installing the accessories ....................................................9

4.2 Documentation output ......................................................9

4.3 Handles ....................................................................10

4.4 ErgonOptic Dent ...........................................................11

4.5 ErgoWedge .................................................................11

4.6 Objectives ..................................................................12

4.7 Protective glass .............................................................12

4.8 Binocular tubes .............................................................13

4.9 Eyepieces ..................................................................13

4.10 Adapter ....................................................................14

4.11 Mounting sterile components ..............................................15

4.12 Installing the drape .........................................................15

4.13 External orange lter .......................................................16

5 SETTINGS ........................................................................17

5.1 Balancing the swing arm ....................................................17

5.2 Transporting the microscope ...............................................18

5.3 Starting up .................................................................20

5.4 Additional settings .........................................................22

6 VIDEO CAMERA ..................................................................28

6.1 Information ................................................................28

6.2 SD memory card ............................................................29

6.3 Remote control .............................................................29

6.4 Graphical user interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

6.5 Acquisition .................................................................44

7 TAKING THE SURGICAL MICROSCOPE OUT OF OPERATION .......................49

8 CARE AND MAINTENANCE .......................................................50

8.1 Maintenance instructions ...................................................50

8.2 Changing fuses .............................................................51

9 TROUBLESHOOTING .............................................................52

9.1 Microscope .................................................................52

9.2 Video camera ..............................................................52

10 SPECIFICATIONS .................................................................61

1

Leica M320 / Ref. 10 718 878 / Version 01

1.3.1 IN THE MANUAL

WARNING

Can cause death or severe injury.

CAUTION

Can cause minor injury.

NOTE

Can cause property damage.

INFO

Information that is not safety-related, but is useful or important.

The Leica surgical microscope is an optical instrument for magnifying and illuminating
specimens. 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 oor or attached to a strong wall or ceiling.
Not for use in eye operations!
The Leica M320 surgical microscope is subject to special precautionary measures for
electromagnetic compatibility. It must be installed and commissioned in accordance with the
guidelines and manufacturer's declarations and recommended safety distances (tables 1, 2, 4,
6 according to EN 60601-1: 2007).
Portable and mobile as well as stationary HF communications equipment can have a negative
eect on the reliabilit y of the Leica M320 surgical microscope.

1.1 BASICS

1.2 INTENDED USE

1.4 REQUIRED TOOLS

Allen key:

- Size 2.5 for installing accessories (dovetail interface)

- Size 3 for optimizing the balance of the optics carrier

- Size 4 for handle holder

- Size 8 for balancing the swing arm

Provided brake knob

1.3.2 ON THE INSTRUMENT

Caution, follow the User Manual

Alternating current

European Conformity logo

1.3 SYMBOLS

Be sure to read the User Manual and the "Safety Notes" chapter carefully before assembling
and operating the product.

Keep the manual close to the instrument.

1 INTRODUCTION

2

2 INSTRUCTIONS

Responsible bo dy

Person or company responsible for the use and maintenance of the surgical microscope
(hospitals, physician's practices).

Users

Physicians and trained medical personnel with appropriate qualications who have been
instructed in the use of the instrument. Specic training is not required.

Authorized trained personn el

Authorized electricians or other technicians expressly authorized by Leica with corresponding
training.

2.1 USER PROFILE S 2.2 SAFETY NOTES

Information for the person responsible for the instrument/authorized trained
personnel

- The surgical microscope may be used by qualied users only.

- Regularly check to make sure the users are complying with safety requirements.

- Provide comprehensive instructions and explain the warning messages.

- Assign and monitor responsibilities for commissioning, operating and maintenance.

- Use the surgical microscope in proper condition only.

- Do not place the drape to close to the instrument, as otherwise it can overheat and shut o.

- Inform your Leica representative or Leica Microsystems (Schweiz) AG immediately if you
detect a product defect that could potentially cause injury or harm.

- Use original accessories or approved Leica accessories only.

- Use only high-quality HDMI cables with a maximum length of 15 m.

- Use only monitors approved for medical purposes or equipped with an isolating transformer.

- Modications or repairs may be carried out by authorized trained personnel only.

- Use only original Leica parts in maintenance work.

- After maintenance or technical modications, readjust the instrument in accordance with
our technical specications.

- If the instrument is modied by or maintenance has been per formed by unauthorized
personnel, if the equipment is improperly maintained or if the instrument has been
operated improperly, Leica disclaims all liabilit y.

- The owner or operator shall be held liable for the function of the system if the system has
been assembled incorrectly by individuals who do not belong to Leica Microsystems
(Schweiz) AG.

- The inuence on other devices by the Leica M320 surgical microscope has been tested in
accordance with EN 60601-1-2. The system passed the emissions and immunity test. The
standard preventive measures and safety regulations pertaining to electromagnetic and
other radiation have to be observed.

3

Leica M320 / Ref. 10 718 878 / Version 01

2 INSTRUCTIONS

2.4 DISPOSAL

The respec tive applicable national laws must be observed for disposal of the products,
with the involvement of corresponding disposal companies.
The unit packaging is to be rec ycled.

2.3 DIRECTIONS FOR THE OPERATOR OF THE INSTRUMENT

- Follow the User Manual.

- Follow the instructions given by your employer regarding the organization of work and
safety at work.

- Do not modify the surgical microscope.

- Danger of tilting of the oor stand! When moving the oor stand, fold up the swing arm as
described above and tighten the articulation brakes.

- Risk of injury from moving parts! Assemble and balance the accessories before the operation.
Do not install it above the eld of operation.

- Risk of injury from rolling of the oor s tand! Always push the microscope to move it; never pull it.
Do not roll it over anyone's feet. Do not roll over cables lying on the oor. Lock the foot brakes
during the operation, and never move the device during operation.

- Do not shine lights in anyone's eyes.

- Do not cover up the ventilation slot of the optics carrier.

- Before an extended period of non-use, remove the battery from the remote control.

4

Rolling oor stand, shor t
swing arm

3 CONTROLS

3.1 S TANDS

Rolling oor stand (F12),
long swing arm

Standard for operating manual

Table stand with terminal
(TC12 )

Ceiling mount (C12)

Table stand with plate (TP12)

Wall stand (W12)

Wall stand (LW12)Floor stand/baseplate (FP12)

NOTE

To assemble the stand, note
the installation instructions
provided.

5

Leica M320 / Ref. 10 718 878 / Version 01

3 CONTROLS

3.2 SWING ARM AND HORIZONTAL ARM

Swing arm and horizontal arm

Move the swing arm upwards.
Light switches o automatically.

Integrated tilt switch

INFO

The integrated tilt switch is
not available for models TC12,
TP 12 and LW12 .

6

INFO

Caps for magnication changer
are steam- or gas-steriliza ble.

INFO

Two dierent versions are
available.

3.4 MICROSCOPE CARRIER

Inclined Upright

3.3 OPTICS CARRIER

3 CONTROLS

Magnication changer,
both sides, increments:

6.4, 10, 16, 25, 40×

Illumination control for
illumination intensity.

Filter and diaphragm controls
for white light, orange lter
and spot illumination.

Types of counterweight for
balancing when many
accessories are used.

INFO

Upright installation is not
possible for models TC12,
TP 12 and LW12 .

7

Leica M320 / Ref. 10 718 878 / Version 01

Tilt brake

3 CONTROLS

3.5 BRAKE KNOBS/ARTICULATION BRAKES

Articulation brake Lever for locking the vertical

position

Rotary brake
(inclined version)

Joint for balancing Articulation brake

Articulation brake
(LW12, TP12, TC12)

Articulation brake

8

3.6 CONNECTIONS

Main switchBrake knob for setting the

articulation brakes

Power socket Port for HDMI/USB cable

3 CONTROLS

9

2 31

Leica M320 / Ref. 10 718 878 / Version 01

INFO

Installing the accessories, for
example, ErgonOptic Dent.
Install any other accessories
in a similar manner.

CAUTION

Risk of injury from downward
movement of the swing arm!
Before installing accessories,
tighten the articulation brakes.
See "5.3 TRANSPORTING THE
MICROSCOPE".

4 ACCESSORIES

C-mount port for commercially
available video camera

4.2 DOCUMENTATION OUTPUT

4.1 INSTALLING THE ACCESSORIES

Push the accessory into the
dovetail interface.

Unscrew the clamping screw. Tighten the clamping screw.

10

2 3

32

1

1

4

5

NOTE

Installing the front handle
before the rest of the
accessories.

INFO

Gray handle sleeves are
steam- or gas-sterilizable.
White handle sleeves can be
disinfected.

4 ACCESSORIES

Ret the handle sleeve holder. Insert until the handle sleeve

clicks into place.

Remove cover with key.Screw the handle apart.

Screw on the handle sleeve
holder.

Screw open the bottom
holder for the handle.
Handle tilt is individually
adjustable.

Push the knob and release
the handle sleeve.

Insert until the handle sleeve
clicks into place.

4.3 HANDLES

4.3.1 INSTALLING AND REMOVING THE FRONT HANDLE

4.3.2 INSTALLING THE SIDE HANDLES

11

Leica M320 / Ref. 10 718 878 / Version 01

INFO

Improves ergonomics at
certain working positions:
Turning range 45° with 180°
binocular tube.

INFO

The ErgoWedge gives a
binocular with a xed angle a
variable viewing angle of 5°
to 25°.

4 ACCESSORIES

Ideal in combination with 45°
inclined binocular tube.

For installation, see "4.1
Installing the accessories".

For installation, see "4.1
Installing the accessories".

ErgoWedge

4.5 ERGOWEDGE

4.4 ERGONOPTIC DENT

ErgonOptic Dent: Optical
extension for more
comfortable work.

12

1

2 3

INFO

Fixed and ne objectives
available in various focal
lengths.

4 ACCESSORIES

Remove the cover from the
optics carrier.

Screw in the objective.

4.6 OBJECTIVES

Turn the ne focusing
objective for ne focus.

Fine focusing objective:
The nose points forward.

Fixed objective:
The nose points 90° towards
the left or right.

4.7 PROTECTIVE GLASS

INFO

The protective glass is used to
protect the objective. The
glass is steam- or gas­sterilizable.

13

21

Leica M320 / Ref. 10 718 878 / Version 01

4 ACCESSORIES

Binocular tube 5° - 25° Inclined binocular tube Binocular tube, 180° variable

4.8 BINOCULAR TUBES

Binocular tube, variable
30° - 150°

Straight binocular tube

Inclined binocular tube 45° For installation, see "4.1

Installing the accessories".

Tighten the rotary ring.Set the eyepiece in place.

4.9 EYEPIECES

INFO

Possible eyepieces:

- 10× eyepiece, standard
(aside from with straight
tube 12.5×)

- 10× eyepiece with crosshair
graticule for easier image
centering

- 12. 5× eyepiece, shows image
with similar magnication to
that on the screen

14

4

5

2

3

1

NOTE

The microscope is not
balanced. To prevent it from
tipping over, tighten the
articulation brakes.

NOTE

For installation, see "4.1
Installing the accessories".

4 ACCESSORIES

Fit the beam splitter.
For 50/50 % or
70/30 % observation.

Install the stereo attachment
for second observer on the
left side.

Install the stereo adapter.

4.10 ADAPTER

Fit the binocular tubes.

Turn the white ring to align
the cutout for the assistant.

15

2 3

1

20 cm

Leica M320 / Ref. 10 718 878 / Version 01

CAUTION

Danger of infection!
Avoid touching the sterile
components. Allow sucient
free space.

CAUTION

Do not wrap the drape around
the microscope too tightly.
The distance between the
microscope and drape should
be 20 cm. Danger of
overheating!

4 ACCESSORIES

4.11 MOUNTING STERILE COMPONENTS

4.12 INSTALLING THE DRAPE

Attach the caps.

Fit the drape.

Attach protective glass on
objective. The noise points
forwards (ne focus
objectives) or 90° to the lef t/
right (xed objectives).

Insert until the handle sleeve
clicks into place.

INFO

Do not install the sterile
components until shortly
before the operation.

Handle sleeves and caps for
the magnication changer
are steam and gas-sterilizable.

Sterilize the handle sleeves
and caps after use.

16

4 ACCESSORIES

External orange lter:
additional accessory for
dentis tr y.

For installation, refer to the
separate Assembly
Instructions provided.

4.13 EXTERNAL ORANGE FILTER

INFO

Filters out the parts of the light
spectrum that cause rapid
curing of dental composite.

NOTE