Leica M320 User manual
From Eye to Insight
MEDICAL DIVISION
User Manual
10734261 - Version 02
M
II M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 1
Thank you for purchasing a Leica surgical microscope, M320.
In developing our systems, we have placed great emphasis on simple, self-
explanatory operation. Nevertheless, we suggest studying this user manual in
detail in order to utilize all the benefits of your new surgical microscope.
For valuable information about Leica Microsystems products and services, and
theaddress 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
andperformance of your Leica Microsystems surgical microscope.
Leica Microsystems (Schweiz)AG Medical Division
Max-Schmidheiny-Strasse 201 CH-9435 Heerbrugg
Tel.: +41 71 726 3333
Fax: +41 71 726 3334
Legal disclaimer
All specifications are subject to change without notice.
The information provided by this manual is directly related to the operation of
theequipment. 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.
You should never use a medical product of Leica Microsystems without the full
understanding of the use and the performance of the product.
Liability
For our liability, please see our standard sales terms and conditions. Nothing in
thisdisclaimer will limit any of our liabilities in any way that is not permitted under
applicable law, or exclude any of our liabilities that may not be excluded under
applicable law.
II M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 1
Contents
1 Introduction 2
1.1 About this user manual 2
1.2 Symbols in this user manual 2
1.3 Required tools 2
2 Product identification 3
3 Safety notes 4
3.1 Intended use 4
3.2 Indications for use 4
3.3 Contraindications 4
3.4 Information for the person responsible
for the instrument 4
3.5 User qualifications 5
3.6 Directions for the user of the instrument 5
3.7 Dangers of use 6
4 Signs and labels 7
5 Design 10
5.1 Stands 10
5.2 Swing arm and horizontal arm 11
5.3 Optics carrier 11
5.4 Microscope carrier 12
5.5 Brake knobs/articulation brakes 12
5.6 Connections 13
6 Functions 14
6.1 Illumination 14
6.2 Balancing system 14
6.3 Footbrakes 15
7 Preperation before surgery 16
7.1 Transportation 16
7.2 Installing the accessories 18
7.3 Documentation output 18
7.4 Handles 18
7.5 ErgonOptic Dent 19
7.6 ErgoWedge 19
7.7 Objectives 20
7.8 Protective glass 20
7.9 Installing the binocular tube 20
7.10 Eyepieces 20
7.11 Adapters 21
7.12 Positioning at the operating table 21
7.13 Mounting sterile components 22
7.14 Installing the drape 22
7.15 Balancing the swing arm 22
7.16 Adjusting the interpupillary distance 22
7.17 Checking the illumination 22
7.18 Changing the accessories of the surgical
microscope and balancing the swing arm 23
7.19 Adjusting the parfocality
with camera and monitor 23
7.20 Adjusting the parfocality
without camera and monitor 24
7.21 Check the remote control and camera 25
7.22 Checklist before surgery 26
8 Operation 27
8.1 Starting up 27
8.2 Adjusting the design LED illuminator 28
8.3 Adjusting the working distance 28
8.4 Adjusting the illumination 29
8.5 Re-equipping during operation 29
8.6 Decommissioning 29
8.7 Binocular tubes 30
8.8 External orange filter 30
8.9 Double Iris Diaphragm 30
9 Video Camera 31
9.1 Information 31
9.2 SD Memory Card 32
9.3 Remote control 32
9.4 On Screen Menu 33
10 Care and maintenance 47
10.1 Care instructions 47
10.2 Maintenance 47
10.3 Notes on reprocessing of resterilizable products 49
10.4 Changing fuses 51
11 Disposal 52
12 What to do if ... ? 53
12.1 Microscope 53
12.2 Video camera 54
13 Specifications 55
13.1 Electrical data 55
13.2 Surgical microscope 55
13.3 Lamps 55
13.4 Stands 56
13.5 Optical data 56
13.6 Accessories 56
13.7 Video accessories 57
13.8 Ambient conditions 57
13.9 Electromagnetic compatibility (EMC) 58
13.10 Compliance IEC 60601-1-2 58
13.11 Standards fulfilled 59
13.12 Limitations on use 59
13.13 Working range 60
13.14 Dimensions F12 (in mm) 61
Introduction
2 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 3
1 Introduction
1.1 About this user manual
In this user manual the surgical microscope M320 is described. The
present user manual applies to the M320 with the following
stand variants: F12, C12, W12, FP12, TC12, LW12 and TP12.
In addition to notes on the use of the instruments this
user manual gives important safety information (see
chapter 3, "Safety notes").
X Read this user manual carefully before operating the
product.
1.2 Symbols in this user manual
The symbols used in this user manual have the following meaning:
Symbol Warning
word
Meaning
Warning
Indicates a potentially 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.
Note
Indicates a potentially hazardous situation
or improper use which, if not avoided, may
result in appreciable material, financial
and environmental damage
Information about use that helps the user
to employ the product in a technically
correct and efficient way.
X Action required; this symbol indicates that
you need to perform a specific action or
series of actions.
1.3 Required tools
Allen keys:
• 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
Product identification
2 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 3
2 Product identification
The model and serial numbers of your product are located on the identification label at the bottom of the horizontal arm.
X 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.
...
...
Safety notes
4 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 5
3 Safety notes
The Leica M320 surgical microscope is state-of-the-art technology.
Nevertheless, hazards can arise during operation. Always follow the
instructions in this user manual, and in particular the safety notes.
3.1 Intended use
• The Leica M320 surgical microscope is an optical instrument for
improving the visibility of objects through magnification and
illumination. It can be applied for observation and
documentation and for human and veterinary medical
treatment.
• The Leica M320 surgical microscope is subject to special
precautionary measures for electromagnetic compatibility.
• Portable and mobile as well as stationary RF communications
equipment can have a negative effect on the reliability of the
Leica M320 surgical microscope's functionality.
• The Leica M320 is intended for professional use only.
3.2 Indications for use
• The Leica M320 surgical microscope is suitable for surgical
applications such as ENT and dental sugeries in hospitals, clinics
or other human medical institutions.
• The Leica M320 surgical microscope may only be used in closed
rooms and must be placed on a solid floor or mounted to the
ceiling.
• This User Manual is intended for physicians, nurses and other
medical and technical staff who prepare, operate or maintain
the device after appropriate training. It is the duty of the device
owner / operator to train and brief all the operating personnel.
3.3 Contraindications
Not for use in ophthalmology.
3.4 Information for the person
responsible for the instrument
X The surgical microscope may be used by qualified and trained
users only, with all covers fitted.
X Only use the surgical microscope if it is free of defects.
X Operate the system only with all equipment in its proper
position (e.g. all covers fitted, doors closed).
X Regularly check to make sure the users are complying with
safety requirements.
X Provide comprehensive instructions and explain the warning
messages.
X Assign and monitor responsibilities for commissioning,
operating and maintenance.
X Use the surgical microscope in proper condition only.
X Do not place the drape too close to the instrument, as otherwise
it can overheat and shut off.
X Inform your Leica representative or Leica Microsystems
(Schweiz) AG immediately if you detect a product defect that
could potentially cause injury or harm.
X Only the following accessories may be used with the surgical
microscope.
X Leica Microsystems accessories described in this user manual.
X Other accessories, provided that these have been expressly
approved by Leica as being technically safe in the context.
X Use original accessories or approved Leica accessories only.
X Use only high-quality HDMI cables with a maximum length of
10 m.
X Use only monitors approved for medical purposes or equipped
with an isolating transformer.
X Modifications or repairs may be carried out by authorized
trained personnel only.
X Use only original Leica parts in maintenance work.
X After maintenance or technical modifications, readjust the
instrument in accordance with our technical specifications.
X If the instrument is modified by or maintenance has been
performed by unauthorized personnel, if the equipment is
improperly maintained or if the instrument has been operated
improperly, Leica disclaims all liability.
X 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.
X The influence 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.
X Only the supplied power cord may be used.
Safety notes
4 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 5
X The power cord must have a protective conductor and must be
undamaged.
X Use of accessories and cables other than those specified or
provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in
improper operation.
X The Leica M320 surgical microscope may be used only in closed
rooms and must be placed on a solid floor.
X Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the LeicaM320,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
X Like any other instrument in the operating theater, this system
may fail. Leica Microsystems (Schweiz) AG therefore
recommends that a backup system be kept available during the
operation.
X Additional equipment connected to medical electrical
equipment must comply with the respective IEC or ISO
standards (e.g. IEC 60950 or IEC 62368 for data processing
equipment). Furthermore all configurations shall comply with
the requirements for medical electrical systems (see clause 16
of the latest valid version of IEC 60601-1). Anybody connecting
additional equipment to medical electrical equipment
configures a medical system and is therefore responsible that
the system complies with the requirements for medical
electrical systems. If in doubt, consult your local representative
or the technical service department.
3.5 User qualifications
The Leica M320 surgical microscrope may be used only by
physicians and medical assistance personnel with appropriate
qualifications who have been instructed in the use of the
instrument. Specific training is not required.
3.6 Directions for the user of the
instrument
X Follow the user Manual.
X Follow the instructions given by your employer regarding the
organization of work and safety at work.
X Do not modify the surgical microscope.
X Danger of tilting of the floor stand! When moving the floor
stand, fold up the swing arm as described above and tighten
the articulation brakes.
X Risk of injury from moving parts! Assemble and balance the
accessories before the operation. Do not install it above the
field of operation.
X Risk of injury from rolling of the floor stand! 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 floor. Lock the foot
brakes during the operation, and never move the device during
operation.
X Do not shine lights in anyone’s eyes.
X Do not switch off/on the surgical microscope during surgery.
X Do not unplug the system during surgery.
X Do not cover up the ventilation slot of the optics carrier.
X Before an extended period of non-use, remove the battery from
the remote control.
X To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
X All parts of the M320 shall not be serviced or maintained while
in use with a patient.
X Lamps shall not be changed while in use with a patient.
X Only use the surgery microscope if it is free of defects.
NOTE
Using accessories or cables other than those specified here or as
approved by the manufacturer of the Leica M320 surgical
microscope can lead to elevated electromagnetic emissions or
reduced interference resistance.
The Leica M320 surgical microscope may not be used in direct
proximity of other devices. 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.
Safety notes
6 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 7
3.7 Dangers of use
WARNING
Risk of death from electrical shock!
X Connect the microscope to a grounded socket only.
WARNING
Danger of injury due to:
• Uncontrolled lateral movement of the arm system,
• Tilting of the stand,
• Trapping of feet in lightweight shoes beneath the casing
of the base.
• Abrupt braking of the surgical microscope at a threshold
that cannot be crossed.
X For transportation, always move the Leica M320 surgical
microscope into the transport position.
X Never move the stand while the unit is extended.
X Never roll the stand or OP equipment over the cables
lying on the oor.
X Always push the Leica M320 surgical microscope; never
pull it.
WARNING
Risk of injury from the binocular tube falling down!
X Tighten the clamping screw securely.
WARNING
Danger of retinal damage!
X Do not shine lights in anyone’s eyes.
WARNING
Do not use for ophthalmology.
Signs and labels
6 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 7
4 Signs and labels
3
12 1
1
13
1
1, 8
9,10
2, 4, 5, 7,
11, 14, 6
14, 6
Signs and labels
8 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 9
1
Tilting danger
2Only to be operated
by trained personnel
Utilisation réservée à
un personnel formé
Trained personnel label
3
Max. load for optics carrier
4Leica Microsystems (Schweiz) AG
Max Schmidheiny-Strasse 201
CH-9435 Heerbrugg
LEICA M320 LW12/ TP12/ TC12/ F12
100 V - 240 V 50 - 60 Hz
100 VA
MODEL
2x T6.3 AH 250 V
Leica Microsystems (Schweiz) AG
Max Schmidheiny-Strasse 201
CH-9435 Heerbrugg
LEICA M320 F12/ W12/ C12/ FP12
100 V - 240 V 50 - 60 Hz
100 VA
MODEL
2x T6.3 AH 250 V
Type label
Medical device
5
Mandatory label - read the user manual carefully before operating the
product. Web address for electronic version of the user manual.
6
UDI Label
7
MET label
(only USA and Canada)
8
Presecription device (USA Only)
Signs and labels
8 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 9
9
OCP 0004
INMETRO label
(only Brazil)
10
ANVISA Registration number
(only Brazil)
11
Grounding label
(only USA and Canada)
12
125 KG
System weight label (F12)
13
Transport position
(F12 floor stand)
14
REF
SN
Fabrication label
a Prefix number
b Leica system article no.
c Serial number
d Incremental number starting at 1 for each batch
e J = year (2 digits)
f MM = month (2 digits)
g TT = day (2 digits)
h Production starting date
Design
10 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 11
5 Design
5.1 Stands
To assemble the stand, note the installation instructions
provided.
1
Rolling floor stand (F12),
long swing arm
Reference model in current user
manual
2
Rolling floor stand, short swing
arm
3
Wall stand (W12)
4
Ceiling mount (C12)
5
Floor stand/baseplate (FP12)
6
Table stand with terminal
(TC12)
7
Wall stand (LW12)
8
Table stand with plate (TP12)
Design
10 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 11
5.2 Swing arm and horizontal arm
1
Swing arm and horizontal arm
2
Integrated tilt switch
Move the swing arm upwards.
Light switches off
automatically.
The integrated tilt switch is not available for models TC12,
TP12 and LW12.
5.3 Optics carrier
Caps for magnification changer are steam- or gas-
sterilizable.
1
Magnification changer,
both sides, increments:
6.4, 10, 16, 25, 40×
2
Illumination control for
illumination intensity.
3
Filter and diaphragm controls
for white light, orange filter
and spot illumination.
4
Counterweight for balancing
when many accessories are
used.
Design
12 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 13
5.4 Microscope carrier
Two different versions are available.
1
Inclined
2
Upright
Upright installation is not possible for models TC12, TP12
and LW12
5.5 Brake knobs/articulation brakes
1
Articulation brake
2
Lever for locking the vertical
position.
3
Joint for balancing
4
Articulation brake
5
Articulation brake
6
Tilt brake
Design
12 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 13
7
Rotary brake
(inclined version)
8
Articulation brake
(LW12, TP12, TC12)
5.6 Connections
1
Brake knob for setting the
articulation brakes
2
Main switch
3
Power socket Port for HDMI/USB cable
Functions
14 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 15
6 Functions
6.1 Illumination
The illumination of the surgical microscope M320 consists of 2 LEDs.
It is located in the optics carrier.
1
Switch on the main switch.
2
White LED illumination on the
optics carrier lights up.
3
Illumination control for
illumination intensity.
4
Filter and diaphragm controls
for white light, orange filter
and spot illumination.
6.2 Balancing system
With a balanced surgical microscope Leica M320 F12 you can move
the optics in any position without it tilting or falling.
1
Remove the screw.
2
Remove the side cover.
3
Remove the screws.
4
Set the desired position.
Four different positions can be
set.
5
Fasten the screws.
6
Refit the side cover.
Functions
14 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 15
7
Fasten the screw.
8
Turn the lever for locking the
vertical position.
9
Adjust the balancing joint to
the weight using an Allen key
(size 8).
6.3 Footbrakes
12
3
Footbrakes are attached to each
of the four wheels on the stand.
The wheel is engaged and
released with the footbrake
engage/release lever (1).
X Press the footbrake engage/
release lever down (3):
X The footbrake is engaged.
X Lift the footbrake engage/
release lever (2):
X The footbrake is released.
Preperation before surgery
16 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 17
7 Preperation before surgery
7.1 Transportation
CAUTION
Risk of injury from outward movement of swinging arm!
X Do not shine lights in anyone’s eyes.
1
X Place swing arm in a
horizontal position.
2
X Tighten the brake knob for
locking the vertical position.
3
X Turn the optics/microscope
carrier towards the outside.
4
X Tighten the articulation
brake.
5
X Open the articulation brake.
6
X Fold the swing arm together.
Tighten the articulation
brake.
7
X Compare the position of the
swing arm with the attached
sign.
8
X Unplug the power cable.
NOTE
Possible damage of the cable!
Always pull the plug, never the
cable.
9
X Release the footbrakes.
Preperation before surgery
16 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 17
10
X Push the microscope to the
installation location and
position it.
CAUTION
Risk of injury to feet!
X Always push the
instrument to move
it; never pull it.
11
X Tighten the footbrakes.
CAUTION
Danger of microscope
rolling away on its own!
X Tighten the
footbrakes.
Preperation before surgery
18 M320 Ref. 10734261 / Version 02 M320 Ref. 10734261 / Version 02 19
7.2 Installing the accessories
CAUTION
Risk of injury from downward movement of the swing arm!
X Before installing accessories, tighten the articulation
brakes, see 7.1, "Transportation"
Installing the accessories, for example, ErgonOptic Dent.
Install any other accessories in a similar manner.
1
X Unscrew the clamping
screw.
2
X Push the accessory into the
dovetail interface.
3
X Tighten the clamping screw.
7.3 Documentation output
C-mount port for commercially
available video camera
7.4 Handles
7.4.1 Installing and removing the front handle
NOTE
Install the front handle before the rest of the accessories
Gray handle sleeves are steam- or gas-sterilizable.
White handle sleeves can be disinfected.
1
X Screw on the handle sleeve
holder.
2
X Insert until the handle
sleeve clicks into place.
3
X Push the knob and release
the handle sleeve.
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2
This manual suits for next models
10
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