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Care and maintenance

34 

Leica M220 F12 / Ref. 10 716 922 / Version 03

10.8  Notes on reprocessing of 

resterilizable products

10.8.1  General

Products

Reusable products supplied by Leica Microsystems (Schweiz) AG 
such as rotary knobs, objective protective glasses and capping 
pieces.

Limitation of reprocessing 

For the medical devices used on patients suffering from Creutzfeldt 
Jacob Disease (CJD) or suspected of having CJD or variant CJD, the 
local statutory requirements have to be met. Normally resterilizable 
products used on this group of patients are to be eliminated 
without risk by incineration.

Occupational safety and health protection

Particular attention must be paid to the occupational safety and 
health protection of the persons responsible for preparing 
contaminated products. Current regulations of hospital hygiene and 
prevention of infection must be observed in the preparation, 
cleaning and disinfection of the products.

Limitation of reprocessing

Frequent reprocessing has little effects on these products. The end 
of the product life cycle is usually determined by wear and tear and 
damage through use.

10.8.2  Instructions

Workplace

 

X

Remove surface contamination with a disposable cloth/paper 
cloth. 

Storage and transport

•  No special requirements.

•  It is recommended to perform the reprocessing of a product 

immediately following its use.

Preparation for cleaning

 

X

Remove the product from the Leica M220 F12 surgical 
microscope.

Cleaning: manually

•  Equipment: running water, detergent, alcohols, microfiber cloth

Procedure 

 

X

 Rinse surface contamination off of the product (temp. < 40 °C). 
Use some rinsing agent depending upon degree of 
contamination.

 

X

Alcohol may also be used to clean the optics if heavy 
contamination such as fingerprints, grease streaks etc. is 
present.

 

X

Dry off products, except for optical components, with a 
disposable cloth/paper cloth. Dry off optical surfaces with a 
micro-fiber cloth.

Cleaning: automatically

•  Equipment: cleaning/disinfecting device

It is not recommended to clean products with optical components 
in a cleaning/disinfecting device. In addition, optical components 
must not be cleaned in ultrasonic baths in order to prevent damage.

Disinfection

The alcohol disinfection solution "Mikrozid. Liquid" may be used in 
accordance with the instructions on the label.
Please note that after disinfection, the optical surfaces must be 
rinsed thoroughly with fresh drinking water, followed by fresh 
demineralized water. The products must be dried thoroughly before 
the subsequent sterilization.

Maintenance

No special requirements.

Control and functional test

Check the snap-on behavior of rotary knobs and handles.

Packaging

Individual: A standard PE bag may be used. The bag must be large 
enough for the product so that the closure is not under tension.

Sterilization

See Sterilization table on chapter 10.8.3.

Storage

No special requirements.

Additional information

None

Contact information of manufacturer

Address of local agent

Leica Microsystems (Schweiz) AG verified that the aforementioned 
instructions for the preparation of a product are suitable for its 
reuse. The processing person is responsible for reprocessing with 
the equipment, materials and personnel and for achieving the 
desired results in the reprocessing installation. In general, this 
requires validations and routine monitoring of the process. Every 
deviation from the supplied instructions should also be examined 
carefully by the processing person to determine effectiveness and 
possible detrimental consequences.

Summary of Contents for M220 F12

Page 1: ...MEDICAL DIVISION User Manual Installation Manual 10 716 922 Version 03 Leica M220 F12...

Page 2: ...rugg 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...

Page 3: ...t optional 21 7 9 Adjusting the parfocality 21 7 10 Changing accessories of the surgical microscope and balancing the swing arm 22 7 11 Attaching the sterile components 22 7 12 Starting up the surgica...

Page 4: ...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...

Page 5: ...t regular inspections to make certain that the authorized users are adhering to safety requirements X When instructing new users do so thoroughly and explain the meanings of the warning signs and mess...

Page 6: ...used no closer than 30 cm 12 inches to any part of the Leica M220 including cables specified by the manufacturer Otherwise degradation of the performance of this equipment could result Note The EMISS...

Page 7: ...ed 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 patien...

Page 8: ...all preparations and adjustments on the optics carrier before the operation X Never rebalance or re equip the optical components and accessories with the instrument over the operation area X Before re...

Page 9: ...neath the base of the stand X Always push the surgical microscope never pull it CAUTION Surgical microscope can move without warning X Always secure the footbrakes when you are not moving the system C...

Page 10: ...Safety notes 8 Leica M220 F12 Ref 10 716 922 Version 03 3 7 Signs and labels 1 11 12 10 2 6 3 9 8 4 5 6 7 15 10 13 14 10 10 10 10...

Page 11: ...tch e JJ year 2 digits f MM month 2 digits g TT day 2 digits h Production starting date 4 Type label 5 Follow the user manual 6 Optical radiation 7 Symbol for fuses 8 Transport position F12 floor stan...

Page 12: ...on 03 4 Design 1 2 5 4 6 7 3 8 14 14 9 12 13 10 11 1 Swing arm 2 XY unit optional 3 Focus unit 4 Tilt head 5 Eyepieces 6 Binocular tube 7 Optics carrier 8 Objective 9 Horizontal arm 10 Column 11 Foots...

Page 13: ...without tilting or falling down After balancing all movements during operation only need a minor force With the rotary knob 3 on the swing arm 2 the drifts will be adjusted The brake knob 1 locks the...

Page 14: ...tch Only connect the footswitch provided by Leica Microsystems Schweiz AG Medical Division 2 Power switch 3 Power connection 4 Cable holder for footswitch cable 5 Power cable strain relief device 6 2...

Page 15: ...ication change The assignment of 1 and 3 magnification and focus control can be switched For additional information refer to the service manual or ask your local after sales service 6 4 Stand 1 3 2 1...

Page 16: ...ection filter GG475 GG435 and protection filter 5 5 5 Emergency drive for the magnification changer In case of emergency the magnification can be adjusted on the emergency drive using a coin or the li...

Page 17: ...microscope can move without warning X Always secure the footbrakes when you are not moving the system CAUTION Surgical microscope can tilting without warning X Always push the surgical microscope in...

Page 18: ...zontal arm and guide it through the cable guide 3 1 2 3 CAUTION Danger of infection X Leave sufficient space around the stand to prevent contact with non sterile components X Inspect all terminals and...

Page 19: ...ely Inclined binocular tube Inclined binocular tube 45 Optional for use on the assistant attachment not a standard configuration Binocular tube 5 25 Optional for use on the assistant attachment not a...

Page 20: ...20 F12 features two slots for additional filters You can use temperature resistant filters with a diameter of 32 mm For further information please contact your Leica Microsystems representative 1 X Pu...

Page 21: ...tting at the eyepiece X Correct the image with the knurled ring 2 7 6 Installing documentation accessories WARNING Risk of injury from parts falling down X Complete all preparations and adjustments on...

Page 22: ...TV dual attachment Zoom video adapter TV attachment 70 mm 1 2 3 1 2 1 3 1 4 107 mm 100 mm 85 mm 60 mm 55 mm 35 mm Photo TV dual attachment TV attachment TV attachment TV attachment Photo TV dual attac...

Page 23: ...e separately 1 only this method will ensure that the image will stay in focus throughout the entire magnification range parfocal Prepare the microscope X Switch on the microscope at the control unit a...

Page 24: ...the swing arm X Hold the microscope firmly X Loosen the brake knob for locking the vertical position 2 The swing arm is now released X By moving the swing arm manually determine whether more force is...

Page 25: ...le replacement LED module ready 1 X Switch on the microscope using the power switch The LED is illuminated X Turn the button 1 to the right This increases the brightness X Test the illumination across...

Page 26: ...eached the LED 1 lights up X Using the footswitch move the focus into reset position see mark 3 Coarse positioning X Hold the microscope by the two handles 4 and position it Fine positioning X Actuate...

Page 27: ...X On the lower potentiometer 3 of the board set the speed to the desired value 3 8 3 Adjusting the magnification X Set the magnification on the footswitch using button 1 chapter 8 2 The following valu...

Page 28: ...scope using the handles 1 X Set the exact working distance using the button on the footswitch for the focus drive 8 6 Decomissioning X End the recording procedure on the camera loss of data X Return t...

Page 29: ...ical microscope swinging down X Do not exceed the max load when equipping components and accessories X Check the total weight using the Load table chapter 9 3 9 1 Observer side 1 2 2 4 Main surgeon As...

Page 30: ...3 Binocular tube inclinable 5 to 25 with PD Adjustable viewing angle and height Adjustable interpupillary distance 3 Binocular tube inclined T type II 3 Binocular tube inclined TC 3 Binocular tube 45...

Page 31: ...eica HD C100 Video adapter For commercially available video cameras with C mount complete with adapter The video adapter 2 is installed at the beam splitter Zoom and fine focus function for Leica Zoom...

Page 32: ...457297 Objective f 225 mm 10448217 Binocular tube inclinable 5 to 25 with PD 0 74 kg 10446574 Binocular tube inclinable T type II 0 74 kg 10446618 Binocular tube 45 0 56 kg 10448404 Binocular tube inc...

Page 33: ...litting compounds strong organic acids oxygen splitting compounds X Follow the disinfectant manufacturer s instructions It is recommended to conclude a service contract with Leica Service Tropical env...

Page 34: ...all the way using your hand 10 5 Replacing the LED module CAUTION Burn hazard The LED module get very hot X Check that the LED module have cooled before you remove it The Leica M220 F12 does not have...

Page 35: ...the footswitch X Press the button on the footswitch The corresponding LED 1 on the board in the FOOT SWITCH FUNCTIONS area must be illuminated If the LED is not illuminated the footswitch may be defec...

Page 36: ...Alcohol may also be used to clean the optics if heavy contamination such as fingerprints grease streaks etc is present X Dry off products except for optical components with a disposable cloth paper cl...

Page 37: ...Clip on handle 10428328 Rotary knob binocular tubes T 10384656 Rotary knob transparent 10443792 Lever extension 10446058 Protective glass multifocal lense 10448439 Protective glass 10448440 Cover ster...

Page 38: ...effort Articulation brakes set too tightly X Loosen the articulation brakes see chapter 7 1 The functions cannot be actuated via the footswitch The cable connection has loosened X Check the power cabl...

Page 39: ...out diagnostics according to chapter 10 7 In the event of a defect contact Leica Microsystems service 12 3 TV photography Malfunction Possible cause Remedy The image on the monitor is too dark The vid...

Page 40: ...ed reflex illumination Light source Direct and long lasting LED illumination Average service life of 60 000 h for an end of life criterion of 70 of the initial brightness UV filter UV and IR free LED...

Page 41: ...2 5 17 4 6 29 2 46 0 7 3 Objective f 200 mm Eyepiece Total magnification mm Field of view mm min max min max 8 33 22 2 7 17 0 68 1 10 8 10 21 3 2 20 4 65 0 10 3 12 5 17 4 0 25 5 52 6 8 3 Objective f 2...

Page 42: ...t for near active HF Surgical Equipment and the RF shielded room of an ME System for magnetic resonance imaging where the intensity of EM Disturbances is high Compliance IEC 60601 1 2 Emissions CISPR...

Page 43: ...Schweiz AG holds the management system certificates for the international standard ISO 13485 relating to quality management and quality assurance 13 10 Limitations of use The Leica M220 F12 surgical...

Page 44: ...Technical data 42 Leica M220 F12 Ref 10 716 922 Version 03 13 11 Dimensions Unit of measure mm...

Page 45: ...MEDICAL DIVISION Installation Manual Leica M220 F12...

Page 46: ...1 Installing the F12 floor stand 46 2 2 Mounting the optics carrier 47 2 3 Installing the XY unit optional and optics carrier 48 2 4 Cabling 49 3 Checklist 50 4 Disassembly 50 5 Instrument Setup 51 5...

Page 47: ...d nuts Tools NOTE Screws or threads can be destroyed X Tighten all screws without using excessive force Allen key 2 5 mm 5 mm Screwdrivers for Phillips head screws Size 0 Assembly material Cable ties...

Page 48: ...the column into the base X Fasten it using the 2 pretreated Allen screws 1 provided X Close off the threaded holes 1 using the plastic plugs provided 2 X Attach the swing arm to the column X Check the...

Page 49: ...rrows 2 on the swing arm and optics carrier must be positioned one above the other X Unscrew the 4 Phillips head screws 3 of the focus cover X Remove the focus cover 4 X Feed the cable from the swing...

Page 50: ...d XY unit must match X Fasten the XY unit to the swing arm using the 4 pretreated Allen screws 10 provided The red arrows on the XY unit and the swing arm must be positioned one above the other 2 3 2...

Page 51: ...asten the power cable 3 to the swing arm using cable ties 5 X Connect the footswitch cable 2 and guide it through the cable guide 4 2 4 2 Routing the video cable optional X Guide the video cable throu...

Page 52: ...ca M220 F12 Ref 10 716 922 Version 03 3 Checklist Are all the cables routed correctly and not pinched 4 Disassembly X Disassemble the Leica M220 F12 surgical microscope in the opposite order in which...

Page 53: ...eica M220 F12 and move the stand over the entire range of movement Result The brakes disengage the microscope can be moved over the entire range of movement freely and without noise X Move down the X...

Page 54: ...d acceptance program This inspection is aimed at determining whether the safety requirements concerning the protection of the patients and of the medical personnel have been fulfilled the performance...

Page 55: ...ntained in the assembly instructions Name and address of the customer Department Representative of Leica Microsystems Schweiz AG Medical Division Name Address Acknowledged Signature Location Date This...

Page 56: ...trasse 201 CH 9435 Heerbrugg T 41 71 726 3333 F 41 71 726 3399 www leica microsystems com 10 716 922en 03Copyright byLeicaMicrosystemsGmbH 2021 Switzerland Subjecttomodifications Printed 01 2021LEICAa...

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