Leica M320 User manual

MEDICAL DIVISION
Leica M320
User Manual
10 718 878 - Version 02

Thank you
for deciding in favor of a Leica surgical microscope system.
In developing our systems, we have placed great emphasis on simple, self-explanatory opera-
tion. Nevertheless, we suggest studying this user manual in detail in order to utilize all the
benets of your new surgical microscope.
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 perfor-
mance of your Leica Microsystems surgical microscope.
Leica Microsystems (Schweiz) AG
Medical Division
Max-Schmidheiny-Strasse 201
CH-9435 Heerbrugg
Tel.: [phone]
Fax: [phone]

Leica M320 / Ref. 10 718 878 / Version 02
CONTENTS
1 INTRODUCTION ..................................................................1
1.1 About this user manual/installation manual ..................................1
1.2 Symbols in this user manual .................................................1
1.3 Required tools...............................................................1
2 PRODUCT IDENTIFICATION .......................................................2
3 SAFETY NOTES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
3.1 Intended use ................................................................3
3.2 Indications for use ...........................................................3
3.3 Contraindications ...........................................................3
3.4 Directions for the person responsible for the instrument .....................3
3.5 Directions for the operator of the instrument.................................4
3.6 Dangers of use ..............................................................4
3.7 Signs and labels .............................................................5
4 DESIGN ...........................................................................7
4.1 Stands. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
4.2 Swing arm and horizontal arm ...............................................8
4.3 Optics carrier ................................................................9
4.4 Microscope carrier...........................................................9
4.5 Brake knobs/Articulation brakes ............................................10
4.6 Connections................................................................11
5 FUNCTIONS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
5.1 Illumination ................................................................12
5.2 Balancing system ...........................................................13
5.3 Footbrakes .................................................................14
5.4 Video camera ..............................................................15
6 PREPARATION BEFORE SURGERY.................................................16
6.1 Transportation .............................................................16
6.2 Installing the accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
6.3 Documentation output .....................................................18
6.4 Handles ....................................................................19
6.5 ErgonOptic Dent ...........................................................20
6.6 ErgoWedge.................................................................20
6.7 Objectives..................................................................21
6.8 Protective glass.............................................................21
6.9 Installing the binocular tube ................................................22
6.10 Eyepieces ..................................................................22
6.11 Adapters ...................................................................23
6.12 Positioning at the operating table...........................................24
6.13 Mounting sterile components ..............................................24
6.14 Installing the drape .........................................................25
6.15 Balancing the swing arm....................................................25
6.16 Adjusting the interpupillary distance........................................26
6.17 Checking the illumination ..................................................26
6.18 Changing the accessories of the surgical microscope and
balancing the swing arm....................................................26
6.19 Adjusting the parfocality with camera and monitor..........................27
6.20 Adjusting the parfocality without camera and monitor ......................29
6.21 Check remote control and camera ..........................................31
6.22 Checklist before surgery ....................................................31

7 OPERATION......................................................................32
7.1 Starting up .................................................................32
7.2 Adjusting the design LED illuminator........................................33
7.3 Adjusting the working distance .............................................34
7.4 Adjusting the illumination ..................................................34
7.5 Re-equipping during operation .............................................35
7.6 Decommissioning ..........................................................35
8 COMPONENTS AND ACCESSORIES ...............................................36
8.1 Binocular tubes.............................................................36
8.2 External orange lter .......................................................37
8.3 Video camera ..............................................................38
9 CARE AND MAINTENANCE .......................................................60
9.1 Care instructions ...........................................................60
9.2 Maintenance ...............................................................60
9.3 Notes on reprocessing of resterilizable products ............................61
9.4 Changing fuses .............................................................62
10 DISPOSAL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .63
11 WHAT TO DO IF...?................................................................64
11.1 Microscope.................................................................64
11.2 Video camera ..............................................................64
12 TECHNICAL DATA ................................................................65
12.1 Electrical data ..............................................................65
12.2 Surgical microscope ........................................................65
12.3 Lamps ......................................................................65
12.4 Stands. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
12.5 Optical Data ................................................................65
12.6 Accessories.................................................................66
12.7 Video Accessories ..........................................................66
12.8 Ambient conditions ........................................................66
12.9 Electromagnetic compatibility (EMC)........................................66
12.10 Standards fullled ..........................................................67
12.11 Limitations on use ..........................................................67
12.12 Working range .............................................................68
12.13 Dimensions F12 (in mm) ....................................................70

1
Leica M320 / Ref. 10 718 878 / Version 02
1.2 SYMBOLS IN THIS USER 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.
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
1.1 ABOUT THIS USER MANUAL/INSTALLATION MANUAL
In this user manual the surgical microscope Leica M320 F12 is described.
In addition to notes on the use of the instruments this user manual gives impor-
tant safety information (see chapter 3).
Read this user manual carefully before operating the product.
1 INTRODUCTION

2
2 PRODUCT IDENTIFICATION
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:

3
Leica M320 / Ref. 10 718 878 / Version 02
3.1 INTENDED USE
• The Leica M320 surgical microscope is an optical instrument for improving the visibility of
objects through magnication and illumination. It can be applied for observation and doc-
umentation and for human and veterinary medical treatment.
• The Leica M320 surgical microscope is subject to special precautionary measures for elec-
tromagnetic compatibility.
• Portable and mobile as well as stationary RF communications equipment can have a nega-
tive eect 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 oor or mounted to the ceiling.
• This User Manual is intended for physicians, nurses and other medical and technical sta
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
No known contraindications for use
3.4 DIRECTIONS FOR THE PERSON RESPONSIBLE FOR THE
INSTRUMENT
- The surgical microscope may be used by qualied and trained users only, with all covers t-
ted.
- Only use the surgical microscope if it is free of defects.
- Operate the system only with all equipment in its proper position (e.g. all covers tted, doors
closed).
- 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.
- Only the following accessories may be used with the surgical microscope.
• Leica Microsystems accessories described in this user manual
• Other accessories, provided that these have been expressly approved by Leica as being
technically safe in the context.
- 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 performed by unauthorized per-
sonnel, if the equipment is improperly maintained or if the instrument has been operated
improperly, Leica disclaims all liability.
- 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.
- Only the supplied power cord may be used.
- The power cord must have a protective conductor and must be undamaged.
- Use of accessories and cables other than those specied or provided by the manufacturer of
this equipment could result in increased electromagnetic emissions or decreased electro-
magnetic immunity of this equipment and result in improper operation.
- The Leica M320 surgical microscope may be used only in closed rooms and must be placed
on a solid oor.
- 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
LeicaM320, including cables specied by the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
- 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.
- 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 congurations 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 congures 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 SAFETY NOTES

4
3.6 DANGERS OF USE
3 SAFETY NOTES
3.5 DIRECTIONS FOR THE OPERATOR OF THE INSTRUMENT
- Follow the user Manual.
- Follow the instructions given by your employer regarding the organization of work and safe-
ty 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 opera-
tion. Do not install it above the eld of operation.
- Risk of injury from rolling of the oor 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 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 switch o/on the surgical microscope during surgery.
- Do not unplug the system during surgery.
- 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.
- To avoid the risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
- All parts of the M320 shall not be serviced or maintained while in use with a patient.
- Lamps shall not be changed while in use with a patient.
- Only use the surgery microscope if it is free of defects.
WARNING
Risk of death from electrical shock!
Connect the microscope to a grounded sock-
et only.
WARNING
Risk of injury from the binocular tube falling
down!
Tighten the clamping screw securely.
WARNING
Danger of injury due to:
- Uncontrolled lateral movement of the arm
system,
- Tilting of the stand,
- Trapping of feet in lightweight shoes be-
neath the casing of the base.
- Abrupt braking of the surgical microscope
at a threshold that cannot be crossed.
For transportation, always move the Leica
M320 surgical microscope into the transport
position.
- Never move the stand while the unit is ex-
tended.
- Never roll the stand or OP equipment over
the cables lying on the oor.
- Always push the Leica M320 surgical mi-
croscope; never pull it.
WARNING
Danger of retinal damage!
Do not shine lights in anyone’s eyes.
WARNING
Do not use for ophthalmology.

5
Leica M320 / Ref. 10 718 878 / Version 02
3.7 SIGNS AND LABELS
Warning Message
Using accessories or cables other than those specied 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.
1UDI Label








2Only to be operated
by trained personnel
Utilisation réservée à
un personnel formé
Trained personnel
3Max. load for optics carrier
4Type label
3
8
12 15
15
13
15
15
9,10
1, 2, 4, 5, 6, 7, 14
2
14
11

6
3 SAFETY NOTES
5Follow the user manual
6Symbol for fuses
7MET label
(only USA and Canada)
8ON / OFF (push-push)
9INMETRO 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 oor stand)
14
REF
SN
Fabrication label
a Prex 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
15 Tilting danger