Leica Microsystems
M320 User Manual Ver 02 Feb 2021
User Manual
66 Pages
Preview
Page 1
MEDICAL DIVISION
From Eye to Insight
M320 User Manual 10734261 - Version 02
Thank you for purchasing a Leica surgical microscope, M320. In developing our systems, we have placed great emphasis on simple, selfexplanatory 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 the address of your nearest Leica representative, please visit our website: www.leica-microsystems.com Thank you for choosing our products. We hope that you will enjoy the quality and performance of your 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 the equipment. 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 this disclaimer 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
Contents 1
2 3
4 5
6
7
Introduction 1.1 About this user manual 1.2 Symbols in this user manual 1.3 Required tools
2 2 2 2
Product identification
3
Safety notes 3.1 Intended use 3.2 Indications for use 3.3 Contraindications 3.4 Information for the person responsible for the instrument 3.5 User qualifications 3.6 Directions for the user of the instrument 3.7 Dangers of use Signs and labels
4 4 4 4
7.18 Changing the accessories of the surgical microscope and balancing the swing arm 7.19 Adjusting the parfocality with camera and monitor 7.20 Adjusting the parfocality without camera and monitor 7.21 Check the remote control and camera 7.22 Checklist before surgery
24 25 26
8
Operation 8.1 Starting up 8.2 Adjusting the design LED illuminator 8.3 Adjusting the working distance 8.4 Adjusting the illumination 8.5 Re-equipping during operation 8.6 Decommissioning 8.7 Binocular tubes 8.8 External orange filter 8.9 Double Iris Diaphragm
27 27 28 28 29 29 29 30 30 30
9
Video Camera 9.1 Information 9.2 SD Memory Card 9.3 Remote control 9.4 On Screen Menu
31 31 32 32 33
10
Care and maintenance 10.1 Care instructions 10.2 Maintenance 10.3 Notes on reprocessing of resterilizable products 10.4 Changing fuses
47 47 47 49 51
4 5 5 6 7
Design 5.1 Stands 5.2 Swing arm and horizontal arm 5.3 Optics carrier 5.4 Microscope carrier 5.5 Brake knobs/articulation brakes 5.6 Connections
10 10 11 11 12 12 13
Functions 6.1 Illumination 6.2 Balancing system 6.3 Footbrakes
14 14 14 15
Preperation before surgery 7.1 Transportation 7.2 Installing the accessories 7.3 Documentation output 7.4 Handles 7.5 ErgonOptic Dent 7.6 ErgoWedge 7.7 Objectives 7.8 Protective glass 7.9 Installing the binocular tube 7.10 Eyepieces 7.11 Adapters 7.12 Positioning at the operating table 7.13 Mounting sterile components 7.14 Installing the drape 7.15 Balancing the swing arm 7.16 Adjusting the interpupillary distance 7.17 Checking the illumination
16 16 18 18 18 19 19 20 20 20 20 21 21 22 22 22 22 22
11
Disposal
23 23
52
12
What to do if ... ? 12.1 Microscope 12.2 Video camera
53 53 54
13
Specifications 13.1 Electrical data 13.2 Surgical microscope 13.3 Lamps 13.4 Stands 13.5 Optical data 13.6 Accessories 13.7 Video accessories 13.8 Ambient conditions 13.9 Electromagnetic compatibility (EMC) 13.10 Compliance IEC 60601-1-2 13.11 Standards fulfilled 13.12 Limitations on use 13.13 Working range 13.14 Dimensions F12 (in mm)
55 55 55 55 56 56 56 57 57 58 58 59 59 60 61
M320 Ref. 10734261 / Version 02
1
Introduction
1
Introduction
1.1
About this user manual
1.2
Symbols in this user manual
The symbols used in this user manual have the following meaning:
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.
Symbol
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
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
product.
Information about use that helps the user to employ the product in a technically correct and efficient way. Action required; this symbol indicates that you need to perform a specific action or series of actions.
X
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
2
M320 Ref. 10734261 / Version 02
Product identification
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.
...
...
M320 Ref. 10734261 / Version 02
3
Safety notes
3
Safety notes
3.4
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
Indications for use
Contraindications
Not for use in ophthalmology.
4
users only, with all covers fitted. X Operate the system only with all equipment in its proper
• 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
X The surgical microscope may be used by qualified and trained X Only use the surgical microscope if it is free of defects.
• 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
Information for the person responsible for the instrument
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 a ccordance 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.
M320 Ref. 10734261 / Version 02
Safety notes 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 Leica M320, 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.
M320 Ref. 10734261 / Version 02
5
Safety notes
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 floor. 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.
6
M320 Ref. 10734261 / Version 02
Signs and labels
4
Signs and labels 3
1, 8
1 1 12
1 2, 4, 5, 7, 11, 14, 6
9,10
13
14, 6
M320 Ref. 10734261 / Version 02
7
Signs and labels 1
2
Tilting danger
Trained personnel label
Only to be operated by trained personnel Utilisation réservée à un personnel formé
3
Max. load for optics carrier
4
Type label
Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 CH-9435 Heerbrugg MODEL
LEICA M320 LW12/ TP12/ TC12/ F12 100 V - 240 V 50 - 60 Hz 100 VA 2x T6.3 AH 250 V
Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 CH-9435 Heerbrugg MODEL
LEICA M320 F12/ W12/ C12/ FP12 100 V - 240 V 50 - 60 Hz 100 VA 2x T6.3 AH 250 V
Medical device
5
6
Mandatory label - read the user manual carefully before operating the product. Web address for electronic version of the user manual.
7
8
8
UDI Label
MET label (only USA and Canada)
Presecription device (USA Only)
M320 Ref. 10734261 / Version 02
Signs and labels 9
INMETRO label (only Brazil) OCP 0004
10
11
ANVISA Registration number (only Brazil)
Grounding label (only USA and Canada)
12
System weight label (F12) 125 KG
13
Transport position (F12 floor stand)
14
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
REF SN
M320 Ref. 10734261 / Version 02
9
Design
5
Design
5.1
Stands
6
Table stand with terminal (TC12)
7
Wall stand (LW12)
8
Table stand with plate (TP12)
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)
10
M320 Ref. 10734261 / Version 02
Design
5.2 1
2
Swing arm and horizontal arm
5.3
Swing arm and horizontal arm
Integrated tilt switch Move the swing arm upwards. Light switches off automatically.
Optics carrier Caps for magnification changer are steam- or gassterilizable.
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.
The integrated tilt switch is not available for models TC12, TP12 and LW12.
M320 Ref. 10734261 / Version 02
11
Design
5.4
1
2
Microscope carrier
5.5
Brake knobs/articulation brakes
Two different versions are available.
1
Articulation brake
2
Lever for locking the vertical position.
3
Joint for balancing
4
Articulation brake
5
Articulation brake
6
Tilt brake
Inclined
Upright
Upright installation is not possible for models TC12, TP12 and LW12
12
M320 Ref. 10734261 / Version 02
Design 7
8
Rotary brake (inclined version)
5.6
Connections
1
Brake knob for setting the articulation brakes
2
Main switch
Articulation brake (LW12, TP12, TC12)
3
Power socket
M320 Ref. 10734261 / Version 02
Port for HDMI/USB cable
13
Functions
6
Functions
6.1
Illumination
6.2
With a balanced surgical microscope Leica M320 F12 you can move the optics in any position without it tilting or falling.
The illumination of the surgical microscope M320 consists of 2 LEDs. It is located in the optics carrier. 1
2
3
4
14
Balancing system
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.
Switch on the main switch.
White LED illumination on the optics carrier lights up.
Illumination control for illumination intensity.
Filter and diaphragm controls for white light, orange filter and spot illumination.
M320 Ref. 10734261 / Version 02
Functions 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
1
2
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.
M320 Ref. 10734261 / Version 02
15
Preperation before surgery
7
Preperation before surgery
7.1
Transportation
6
X Fold the swing arm together.
Tighten the articulation brake.
CAUTION Risk of injury from outward movement of swinging arm! X Do not shine lights in anyone’s eyes. 1
7
swing arm with the attached sign.
X Place swing arm in a
horizontal position.
2
X Compare the position of the
X Tighten the brake knob for
locking the vertical position.
3
X Turn the optics/microscope
carrier towards the outside. 8
X Unplug the power cable.
NOTE
4
Possible damage of the cable! Always pull the plug, never the cable.
X Tighten the articulation
brake. 9
5
16
X Open the articulation brake.
M320 Ref. 10734261 / Version 02
X Release the footbrakes.
Preperation before surgery 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.
M320 Ref. 10734261 / Version 02
17
Preperation before surgery
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"
7.4
Handles
7.4.1
Installing and removing the front handle
NOTE Install the front handle b efore the rest of the accessories
Gray handle sleeves are steam- or gas-sterilizable. White handle sleeves can be disinfected.
Installing the accessories, for example, ErgonOptic Dent. Install any other accessories in a similar manner. 1
X Unscrew the clamping
1
holder.
screw.
2
X Push the accessory into the
2
7.3
X Tighten the clamping screw.
3
Documentation output C-mount port for commercially available video camera
18
X Insert until the handle
sleeve clicks into place.
dovetail interface.
3
X Screw on the handle sleeve
M320 Ref. 10734261 / Version 02
X Push the knob and release
the handle sleeve.