User Manual
86 Pages
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Page 1
MEDICAL DIVISION
M844 User Manual 10 713 294 - Version 01
Thank you for purchasing a Leica surgical microscope system. 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
M844 / Ref. 10 713 294 / Version 01
Contents 1
Introduction 1.1 About this user manual 1.2 Symbols in this user manual
3 3 3
2
Product identification 2.1 Optional product features
3 3
3
Safety notes 3.1 Intended use 3.2 Indication for Use 3.3 Contraindications 3.4 Directions for the person responsible for the instrument 3.5 Directions for the operator of the instrument 3.6 Dangers of use 3.7 Signs and labels
4 4 4 4 4 5 6 10
Design 4.1 Leica M844 F40 4.2 Leica M844 F20 4.3 Leica M844 CT40 4.4 Leica M844 Optics carrier
15 15 17 19 21
Functions 5.1 Illumination 5.2 Balancing system 5.3 Electromagnetic brakes
22 22 22 22
6
Controls 6.1 Control unit 6.2 Leica M844 surgical microscopes 6.3 Footswitch and handles
23 23 24 25
7
Preparation before surgery 26 7.1 Transportation 26 7.2 Installing optical accessories 27 7.3 Setting the binocular tube 28 7.4 Adjusting the eyepiece 28 7.5 Adjusting optical accessories for Leica M844 29 7.6 Installing documentation accessories 30 7.7 Selecting documentation accessories 31 7.8 Fitting optical accessories for Leica M844 32 7.9 Fitting the Leica Slit Illuminator 33 7.10 Wide-angle observation system (such as Oculus) 36 7.11 Stand settings (F40, CT40) 37 7.12 Stand settings (F20) 39 7.13 Positioning at the operating table 39 7.14 Attaching sterile controls and drape 40 7.15 Function check 41
4
5
8
Operation
42
8.1 8.2 8.3 8.4 8.5 8.6 8.7
Switching the microscope on Positioning the microscope Adjusting the microscope Adjusting the magnification (zoom) Transport position Rest position Shutting down the surgical microscope
42 43 44 46 47 47 47
9
Touch panel 9.1 Menu structure 9.2 Switching the microscope on 9.3 Editing the user list 9.4 Configuring users (User Settings menu) 9.5 StepCycle™ 9.6 The Maintenance menu 9.7 The "How to…" menu 9.8 The "Service" menu
47 47 47 49 49 52 55 56 56
10
Accessories 57 10.1 Devices and accessories manufactured by Leica 57 10.2 Devices and accessories of Leica and of 3rd party manufacturers 60 10.3 Video accessories for M844 60 10.4 Drapes 60
11
Care and maintenance 61 11.1 Maintenance instructions 61 11.2 Cleaning the touch panel 61 11.3 Maintenance 61 11.4 Care and Maintenance of the Leica Foot switch 61 11.5 Changing fuses 62 11.6 Changing lamps 62 11.7 Notes on reprocessing of resterilizable products 63
12
Disposal
66
13
What to do if ...? 13.1 General 13.2 Microscope 13.3 Control unit 13.4 Error messages on the control unit 13.5 F40 stand 13.6 CT40 ceiling mount 13.7 F20 stand 13.8 Camera, video
66 66 66 67 68 68 68 68 69
14
Specifications 14.1 Microscope 14.2 Illumination 14.3 Accessories 14.4 Electrical data
70 70 70 70 71
M844 / Ref. 10 713 294 / Version 01
1
15
14.5 Auxiliary power socket 14.6 Optical data 14.7 Stands 14.8 Ambient conditions 14.9 Electromagnetic compatibility (EMC) 14.10 Standards fulfilled 14.11 Configurations and Weights 14.12 Limitations of use 14.13 List of weights of balanceable configurations 14.14 Dimensional drawings
71 71 72 72 73 73 73 74 76 78
Annex 15.1 Checklist before the operation
81 81
This manual covers the following systems: • M844 F40 • M844 F20 • M844 CT40
2
M844 / Ref. 10 713 294 / Version 01
Introduction
1
Introduction
1.1
About this user manual
2
In this user manual the surgical microscope M844 is described. In addition to notes on the use of the instruments this user manual gives important safety information (see chapter 3).
X Read this user manual carefully before operating
the product.
1.2
Symbols in this user manual
Product identification
The model and serial numbers of your product are located on the identification label on the illumination unit. 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.
...
...
2.1
Optional product features
Different product features and accessories are optionally available. The availability varies from country to country and is subject to local regulatory requirements. Please contact your local representative for availability.
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.
Technical documentation and Assembly instruction
The Technical documentation is part of the document “Assembly instruction”.
M844 / Ref. 10 713 294 / Version 01
3
Safety notes
3
Safety notes
X When instructing new users, do so thoroughly and explain the
The M844 surgical microscope is state-of-the-art technology. Nevertheless, hazards can arise during operation. X Always follow the instructions in this user manual, and in particular the safety notes.
meanings of the warning signs and messages. X Allocate responsibilities for commissioning, operation and
maintenance. Monitor compliance with this. X Only use the M844 surgical microscope when it is free of
defects. X Inform your Leica representative or Leica Microsystems
3.1
Intended use
• The M844 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 M844 surgical microscope may be used only in closed rooms and must be placed on a solid floor. • The M844 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 M844 surgical microscope's functionality. • The M844 is intended for professional use only.
3.2
Indication for Use
• The M844 surgical microscope is suitable for ophthalmic application such as Retina, Cornea and Cataract surgery in hospitals, clinics or other human medical instituations. • The M844 surgical microscope may only be used in closed rooms and must be placed on a solid floor or mounted to the ceiling. • These Instructions for Use are 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
No known contraindications for Use.
3.4
Directions for the person responsible for the instrument
X Ensure that the M844 surgical microscope is used only by
persons qualified to do so. X The M844 surgical microscope may only be operated by trained personnel. X Ensure that this user manual is always available at the place where the M844 surgical microscope is in use. X Carry out regular inspections to make certain that the authorized users are adhering to safety requirements.
4
(Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland, immediately about any product defect that could potentially cause injury or harm. X If you use accessories from other manufacturers with the M844 surgical microscope, make sure that these manufacturers confirm that the combination is safe to use. Follow the instructions in the user manual for those accessories. • Only the following accessories may be used with the Leica M844 surgical microscope: • The Leica Microsystems accessories described in chapter 10 this User Manual. • Other accessories, provided that these have been expressly approved by Leica as being technically safe in this context. • Modifications to or service on the M844 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 servicing the product. • After service work or technical modifications, the device must be readjusted in accordance with our technical specifications. • If the instrument 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 Microsystems will not accept any liability. • The effect of the surgical microscope on other instruments has been tested as specified in EN 60601-1-2. The system passed the emission and immunity test. Comply with the usual pre cautionary and safety measures relating to electromagnetic and other forms of radiation • The electric installation in the building must conform to the national standard, e.g., current-operated ground leakage protection (fault-current protection) is suggested. • Like any other instrument in the operating theater, this system may fail. Leica Microsystem (Schweiz) AG therefore recommends that a backup system is kept available during the operation. • Only the supplied power cord may be used. • The power cord must have a protective conductor and must be undamaged. • The mains cable must be mechanically secured with the "Power Input" socket to prevent accidental disconnection. • The Leica Microsystems surgical microscope may be used only by physicians and medical assistance personnel with
M844 / Ref. 10 713 294 / Version 01
Safety notes
•
• • •
•
•
appropriate qualifications who have been instructed in the use of the instrument. Specific training is not required. Connecting electrical equipment to the Auxiliary Power outlet will result in the establishment of a “ME System” and may result in a reduced level of safety. The corresponding standard requirements for “ME Systems” must be observed. All parts of the M844 shall not be serviced or maintained while in use with a patient. Lamps shall not be changed while in use with a patient. Use of this equipment adjacent to other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use of accessories and cables other than those specified or provided by the manufacturer of his equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 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 M844, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Note: The EMISSIONS characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.
3.5
Directions for the operator of the instrument
X Follow the instructions described here. X Follow the instructions given by your employer regarding the
Phototoxic damage to the retina during eye surgery WARNING Damage to the eyes due to prolonged exposure! The light of the instrument may be harmful. Risk of eye damage increases with the duration of exposure. X During exposure to the light from this instrument, do not exceed the hazard reference values. If the exposure time exceeds 2 min with this instrument at maximum output power, the hazard reference value will be exceeded.
The following table is intended to serve as a guideline and make the surgeon aware of the potential hazard. The data have been calculated for the worst-case scenario: • Eye with aphakia • Completely unmoving eye (continuous irradiation of the same region) • Uninterrupted light exposure, e.g. no surgical instruments in the eye • Pupils dilated to 7 mm The calculations are based on the corresponding ISO standards1) 2) and the exposure limit values recommended in them. Published literature shows that a moving eye may allow for increased time of exposure 3). Main light Light setting
Recommended maximum exposure time according to 1) [min.] Without filter
With GG435 filter
With GG475 filter
25 %
55 min
1 h 4 min
3 h 3 min
50 %
12 min
15 min
44 min
75 %
4 min
5 min
17 min
100 %
2 min
2 min
8 min
10 % - Retina Protection Function Active
3 h 19 min
n/a
n/a
organization of work and safety at work. X Check the illumination intensity before and during surgery. X Don't move system without released brakes. X Operate the system only with all equipment in its proper position (all covers fitted, doors closed).
M844 / Ref. 10 713 294 / Version 01
5
Safety notes OttoFlex™ illuminator Light setting
Recommended maximum exposure time according to1) [min.] Without filter
25 %
1 h 9 min
50 %
14 min
75 %
5 min
100 %
2 min
20 % - Retina Protection Function Active
Stability (floor stands only)
When moved in the operating room, the swing arm must be folded up and locked and the brakes must be applied, otherwise the swing arm could drift out of control and the stand could topple. Hazards due to movable parts
1 h 42 min
Sources: 1) DIN EN ISO 15004-2:2007 Ophthalmic instruments – Fundamental requirements and test methods – Part 2: Light hazard protection. 2) ISO 10936-2:2010 Optics and photonics – Operation microscopes/Part 2: Light hazard from operation microscopes used in ocular surgery. 3) David Sliney, Danielle Aron-Rosa, Francois DeLori, Franz Fankhauser, Robert Landry, Martin Mainster, John Marshall, Bernhard Rassow, Bruce Stuck, Stephen Trokel, Teresa Motz West and Michael Wolffe, Adjustment of guidelines for exposure of the eye to optical radiation from ocular instruments: statement from a task group of the International Commission on Non-Ionizing Radiation Protection (ICNIRP) APPLIED OPTICS, Vol. 44, No. 11, p. 2162 (10 April 2005). Protect the patient with the following safeguards: • Short illumination times • Low brightness setting • Use of protective filters • Switching off the illumination during breaks in the operation It is recommended to adjust the brightness to the minimum necessary for the surgery. Infants, patients with aphakia (whose eyelens has not been replaced by an artificial lens with a UV protection screen), small children and persons with diseases of the eye are at greater risk. The risk is also increased if the person being treated or operated on has, within the last 24 hours, already been exposed to illumination from the same or any other ophthalmological instrument that uses a bright visible light source. This applies especially to patients that have been examined via retinal photography. The decision about which light intensity to use for an application must be made on a case-by-case basis. In any event, the surgeon must evaluate the risks and benefits of the used light intensity. Despite all efforts to minimize the risk of retinal injury by surgical microscopes, damage may still occur. Photochemical retinal damage is a possible complication of the necessity to use bright light to make eye structures visible during difficult ophthalmological processes.
6
In addition, the Retina Protection function can be activated during the surgery to reduce the main light intensity up to 10% and OttoFlex up to 20%.
This section describes uses that, inadvertently, could lead to hazardous situations. • Add accessories and balance the stand before the operation, and never over the field of operation. • Never put your hand between the gas spring and the swing arm; it could become trapped when the swing arm is moved. • Do not put your fingers between the microscope and the focusing drive; They could get crushed. Floor stand • Always push the instrument to move it; never pull it. Feet in lightweight shoes could become trapped beneath the casing of the base. • The footbrakes must remain engaged throughout the operation. Electrical connections
The control unit may be opened only by a Leica-approved service technician. Accessories
Only the following accessories may be used with the Leica M844 surgical microscopes: • The Leica Microsystems accessories described in this User Manual. • Other accessories, provided that these have been expressly approved by Leica as being technically safe in this context.
3.6
Dangers of use 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. X For transportation, always move the M844 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 M844 surgical microscope; never pull it.
M844 / Ref. 10 713 294 / Version 01
Safety notes WARNING
WARNING
Risk of injury due to downward movement of the surgical microscope. X Complete all preparations and adjustments to the stand before the operation. X Never change the accessories or attempt to rebalance the microscope while it is above the field of operation. X Balance the M844 after re-equipping it. X Do not release the brakes when the instrument is in an unbalanced state. X Before re-equipping during the operation, first swing the microscope away from the operating field. X After re-equipping, always rebalance the microscope on the swing arm. X Never carry out the balancing above the patient. X See safety notes in user manual. X Don't use the down / up movement of ceiling mount when the microscope is over the patient.
Risk of injury due to downward movement of the surgical microscope! X Never change the accessories or attempt to rebalance the microscope while it is above the field of operation. X After re-equipping, always rebalance the microscope on the swing arm.
WARNING Burn hazard! X The lamp housing and cover may become hot during use. WARNING
WARNING Risk of injury due to downward movement of the surgical microscope. X Complete all preparations and adjustments to the stand before the operation. X Never change the accessories or attempt to rebalance the microscope while it is above the field of operation. X Before changing accessories, always lock the M844. X Balance the M844 after re-equipping it. X Do not release the brakes when the instrument is in an unbalanced state. X Before re-equipping during the operation, first swing the microscope away from the operating field. X Never carry out the balancing above the patient. X See safety notes in user manual. X Don't use the down / up movement of ceiling mount when the microscope is over the patient.
Danger of injury to the eyes due to possibly hazardous optical infrared and UV radiation. X Do not look at the operating lamp. X Minimize exposure to eyes or skin. X Use appropriate shielding.
Risk of injury to the patient. X Don't switch on/off during surgery. X Don't unplug systm during surgery.
WARNING
WARNING
Danger of eye injuries! The light source of the slit illuminator might be too bright for the patient. X Dim the slit illuminator before switching it on. X Slowly increase the brightness until the image is illuminated optimally for the operating doctor.
Danger of eye injuries! There is a danger of injury to the patient as a result of changing the working distance using the motorized adjustment of the ceiling mount if the working distance falls below the minimum of 140 mm due to the use of accessories (such as wide-angle observation systems). X The footswitch function for moving the ceiling mount up and down may not be used in combination with accessories that cause the working distance to fall below the minimum of 140 mm. X Before up/down movements, always check first to ensure that the range of movement is free of obstructions.
WARNING Damage to the eyes due to prolonged exposure! The light of the instrument may be harmful. Risk of eye damage increases with the duration of exposure. X During exposure to the light from this instrument, do not exceed the hazard reference values. An exposure to this instrument for longer than 2 min at maximum output power exceeds the exposure limits.
WARNING
M844 / Ref. 10 713 294 / Version 01
7
Safety notes WARNING
WARNING
Risk of injury due to downward movement of the surgical microscope! X Always lock the swing arm: • when transporting the microscope • when re-equipping.
Beware of: • Uncontrolled lateral movement of the swing arm! • Tilting of the stand! • Feet in lightweight shoes could become trapped beneath the casing of the base. • Collision between user and microscope system. E.g. between head and camera control unit holder (CT40) • Abrupt braking of the surgical microscope at a threshold that cannot be crossed. X Before transport, always move the Leica M844 F20 surgical microscopes into the transport position. X Never move the stand in the extended condition. X Always push the surgical microscope; never pull it. X Never roll over cables lying on the floor.
WARNING Risk of injury due to downward movement of the surgical microscope! X Complete all preparations and adjustments to the stand before the operation. X If settings need to be altered during the operation, first swing the microscope away from the operating field. X If the microscope needs to be re-equipped, do this before the operation. X Before re-equipping, always lock the swing arm. X Do not use the handles or remote brake release when the instrument is in an unbalanced state. WARNING Risk of infection. X Always use the M844 surgical with sterile controls and a sterile drape. WARNING Danger of fatal electrical shock. X The M844 surgical microscope may be connected to a grounded socket only. X Operate the system only with all equipment in its proper position (all covers fitted, doors closed).
WARNING Motors return to their home positions X Before switching on your Leica M844, ensure that the travel paths of the XY, zoom and focus motors are free of obstructions. The tilt motor is not moved. WARNING Danger of fatal electric shock! X Disconnect the power cable from the power socket before changing fuses. WARNING Halogen lamps become very hot! X Always switch the main switch off before changing a bulb. X Allow bulbs to cool for 20 minutes before changing them (burn hazard!). WARNING Risk of injury from downward movement of surgical microscope! X Do not exceed the max. load when equipping components and accessories. X Check the total weight using the "List of weights of balanceable configurations".
8
M844 / Ref. 10 713 294 / Version 01
Safety notes WARNING
CAUTION
Light that is too intense can damage the retina. X Observe the warning messages in the "Safety Notes" chapter.
Risk of infection. X Leave sufficient space around the stand to ensure that the sterile drape does not come into contact with non-sterile components.
WARNING Risk of injury! X Pay special attention to the required safety distances if you use the StepCycle™ function together with accessories from other manufacturers that can reduce the working distance to less than 140 mm (non-contact wide-angle observation systems), since focus together with StepCycle is a semi-automated function. WARNING Danger of injury to the eyes. X Minimize speed of focus motor during retina surgery. CAUTION Connecting unauthorized secondary devices to the auxiliary power socket can lead to damage to the surgical microscope and to the secondary device! X Never connect secondary devices to the auxiliary power socket unless they conform to the specifications. Requirements of use, see chapter 14.5.
CAUTION Damage to the M844 surgical microscope due to uncontrolled tilting. X Hold the handle when releasing the brake. CAUTION Destruction of the zoom motor! X Only adjust the zoom manually if the zoom motor is defective. CAUTION Danger of injury from uncontrolled lateral movement of the system and arm systems. X When transporting or moving the microscope (F20, F40) on an inclined plane, always lock the swing arm, monitor arm and control unit (see 14.12) X When storing the microscope (F20 only) on an inclined plane use the provided wedge from the transport box (see 14.12).
CAUTION Surgical microscope can move without warning. X Always lock the footbrake when you are not moving the system. CAUTION Danger of crushing due to moving parts! The parts of the slit illuminator that are moved by motors may crush fingers or the hand when used improperly. X When handling the slit illuminator, take care not to crush any fingers. CAUTION There is a risk of damage to the surgical microscope from uncontrolled tilting! X Firmly hold the handles before triggering the "All Brakes" function.
M844 / Ref. 10 713 294 / Version 01
9
Safety notes
3.7
Signs and labels
Floor stand, horizontal arm, and swing arm F20 18
10
15
17 10 15 10
10,15 15 1
9
11
2
14
8, 16
5
4
3
12
6
10
7
M844 / Ref. 10 713 294 / Version 01
8
13
Safety notes Danger sign for hot surface
1
2
Leica M844
OCP 0004
Mandatory label - read the user manual carefully before operating the product. Web address for electronic version of the user manual. Medical Device
3
4
Type label
Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 CH-9435 Heerbrugg MODEL
12
System weight label (F20)
13
MET label
14
ANVISA Registration number (only brazil)
15
Tilting danger
LEICA M844 / M822 F20 100 V - 240 V 50-60 Hz 400 VA 2x T6.3 AH/250V
Max. power output
5
16
Grounding label (only USA and Canada)
8
REF SN
UDI Label
Equipotential bonding
6
7
INMETRO label (only brazil)
11
Max. 10.5kg (23.15lb)
Max. load for monitor arm
Max. 11.5kg (25.35lb)
Max. load for optics carrier
17
18
a b
Fabrication label a Reference number b Serial number
9
Transport position (F20 floor stand)
10
Danger sign for squeezing hazard
M844 / Ref. 10 713 294 / Version 01
11
Safety notes F40 floor stand 19 12 11
1
2
Horizontal arm and swing arm F40 / CT40 4
5
6
7
3
21
21 10
9 8 13
16 19 17 18
14 max. power output 100 VA T1 AH/250 V Grounding reliability can only be achieved when EQUIPMENT is connected to equivalent receptacle marked "Hospital only" or "Hospital Grade". La fiabilité de la mise à la terre n'est assurée que si l'équipement est connecté à une prise équivalente, mar quée "Hôpital seulement" ou "Qualité hôpital".
12
15
-
M844 / Ref. 10 713 294 / Version 01
Safety notes Transport position (F40 floor stand)
1
15
Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 CH-9435 Heerbrugg MODEL
Danger sign for squeezing hazard
3
4
Fix points for video cable
5
Open
6
Closed
7
Max. load for optics carrier
8
Max. 12.2kg (26.90lb)
10
MODEL
17 18
Danger sign for hot surface CAUTION HIGH PRESSURE DO NOT OPEN
11
Danger sign for high pressure in the gas spring ANVISA Registration number (only brazil)
LEICA M844 / M822 C40 100 V - 240 V 50-60 Hz 100 VA 2x T6.3 AH/250V
Mandatory label - read the user manual carefully before operating the product. Web address for electronic version of the user manual. Medical Device
16
Leica M844
9
LEICA M844 / M822 F40 100 V - 240 V 50-60 Hz 550 VA 2x T6.3 AH/250V
Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 CH-9435 Heerbrugg
System weight label (F40)
2
max. power output 100 VA T1 AH/250 V
19
Max. 8.5kg (18.74lb)
13
14
REF SN
a b
Fabrication label a Reference number b Serial number
Grounding label (only USA and Canada)
UDI Label
20
OCP 0004
Max. power output
INMETRO label (only brazil)
12
Type labels
21
Max. load monitor arm
Tilting danger
MET label
M844 / Ref. 10 713 294 / Version 01
13
Safety notes Leica Telescope Mount
1
Type labels
1
Leica Microsystems (Schweiz) AG Max Schmidheiny-Strasse 201 CH-9435 Heerbrugg MODEL
14
LEICA M844 / M822 C40 100 V - 240 V 50-60 Hz 100 VA 2x T6.3 AH/250V
M844 / Ref. 10 713 294 / Version 01
Design
4
Design
4.1
Leica M844 F40 3
4 5
9
1
6 7 13
2 15
10
8
14
11
12
1 2 3 4 5 6 7 8
Control unit Horizontal arm Swing arm XY-unit Binocular tube 0° assistant’s attachment (Leica M844 only) Handles Optics carrier
9 Tilt head 10 Column 11 Cable support 12 Base 13 Holding fixture for video control unit 14 Hand rail 15 Suspension device for footswitch
M844 / Ref. 10 713 294 / Version 01
15
Design F40 floor stand
18 17
16
21
7 22
23
24
25
26
20 19
28 27
T1AH/250V
7 Handles 16 Power switch 17 Balancing knob 18 Swing arm stop lever 19 Footbrake release lever 20 Footbrake 21 Touch panel 22 Power supply 23 Fuse holder (2× 6.3 AH, time-lag) 24 Running-time meter for the surgical microscope 25 Socket for potential equalization For connecting the Leica M844 to an equipotential bonding device. This is part of the customer's building installation. Observe the requirements of EN 60601-1 (§ 8.6.7).
16
26 Socket for remote brake release 27 Auxiliary power outlet (max. output power 100 VA ) Requirements of use, see chapter 14.5 28 Fuse holder (1 AH, time-lag) CAUTION Connecting unauthorized secondary devices to the auxiliary power socket can lead to damage to the surgical microscope and to the secondary device! X Never connect secondary devices to the auxiliary power socket unless they conform to the specifications. Requirements of use, see chapter 14.5
M844 / Ref. 10 713 294 / Version 01
Design
4.2
Leica M844 F20
12 13
14
11
1 2 3 4 5 6 7
Control unit Horizontal arm Swing arm XY-unit Binocular tube 0° assistant’s attachment (Leica M844 only) Handles
8 Optics carrier 9 Tilt head 10 Column 11 Base 12 Holding fixture for video control unit 13 Hand rail 14 Suspension device for footswitch 15 Optional monitor arm
M844 / Ref. 10 713 294 / Version 01
17
Design F20 floor stand
2 3 1 5 3 6
9 10 11
8
4
7
1 Touch panel 2 Retaining hook (blocks swing arm) 3 Articulation brakes (regulate ease of movement) 4 Handles 5 Balancing knob 6 Power switch 7 Footbrake release lever 8 Footbrake 9 Power supply 10 Fuse holder (2× 6.3 AH, time-lag) 11 Socket for potential equalization For connecting the Leica M844 to an equipotential bonding device. This is part of the customer's building installation. Observe the requirements of EN 60601-1 (§ 8.6.7).
18
12 13
12 Auxiliary power outlet (max. output power 100 VA) For requirements of use, see chapter 14.5. 13 Fuse holder (1 AH, time-lag) CAUTION Connecting unauthorized secondary devices to the auxiliary power socket can lead to damage to the surgical microscope and to the secondary device! X Never connect secondary devices to the auxiliary power socket unless they conform to the specifications. Requirements of use, see chapter 14.5
M844 / Ref. 10 713 294 / Version 01