M525 F20-CT20 User Manual Ver 01 May 2018

 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 so that you know and are able to utilize all the benefits of your Leica surgical microscope in an optimum way. 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 new Leica Microsystems surgical microscope. Leica Microsystems (Schweiz) AG Medical Division Max-Schmidheiny-Strasse 201 CH-9435 Heerbrugg Phone: +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.

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Leica M525 F20/CT20 / Ref. 10 715 156 / 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 of instrument 3.2 Notes on use 3.3 Contraindications 3.4 Information for the person responsible for the instrument 3.5 Instructions for the user 3.6 Dangers of use 3.7 Labels and symbols

4 4 4 4 4 5 6 10

Design 4.1 Leica M525 F20 surgical microscope 4.2 Leica M525/CT20 ceiling mount

13 13 14

Function 5.1 Balancing system 5.2 Brakes 5.3 Tilt of the microscope carrier 5.4 Illumination

15 15 15 16 16

Controls 6.1 Leica M525 surgical microscope with microscope carrier 6.2 Control/illumination unit 6.3 Swing arm 6.4 Footswitch 6.5 Handswitch 6.6 CT20 ceiling mount

17

Preparation before Surgery 7.1 Transport (F20 only) 7.2 Cleaning the optical accessories 7.3 Mounting the accessories 7.4 Balancing the Leica M525 F20/CT20 surgical microscope 7.5 Setting up eyepieces 7.6 Configuring control unit 7.7 Performing function checks 7.8 Raising and lowering the CT20 ceiling mount 7.9 Positioning at the operating table (F20 only) 7.10 Adjusting the tilt of the microscope carrier (45°/70°) 7.11 Balancing the Leica M525 F20/CT20 surgical microscope

20 20 21 21

4

5

6

7

17 18 19 19 19 19

21 21 21 21 22 22 24 24

7.12 7.13 7.14

Balancing the swing arm Adjusting the articulation brakes Setting position for "posterior fossa sitting" (sitting patient)

26 26 26

8

Operation 27 8.1 Toggling the illumination 28 8.2 Setting the illumination field diameter 29 8.3 Working with LASER and locking/releasing the multi-focal focus 29 8.4 Determining diopter settings for users 30 8.5 Setting up eyepieces 30 8.6 Attaching the protective glass to the objective 30 8.7 Attaching sterile controls 31 8.8 Control unit with touch panel 32 8.9 Controlling the zoom and focus 37 8.10 Taking the surgical microscope out of operation 39

9

Accessories 9.1 Dual stereo attachment 9.2 Binocular tube; can be tilted; with variable viewing angle 30°–150° 9.3 Stereo attachment for second observer 9.4 Video-zoom tube 9.5 Adapter piece for accessories of the Leica M600 series 9.6 Beam splitter 9.7 Mounting the accessories 9.8 Accessories list for advanced configurations

40 40

10

Care and Maintenance 10.1 Maintenance instructions 10.2 Changing lamps 10.3 Removing a defective lamp 10.4 Replacing fuses 10.5 Function check 10.6 Reprocessing of re-sterilizable products 10.7 Maintenance

43 43 43 44 45 45 46 47

11

Disposal

48

12

What to do, if … 12.1 Malfunctions on the Leica M525 F20/CT20 surgical microscope 12.2 Malfunctions on the stand/mount 12.3 Malfunctions on the TV, photography

49

Technical Data 13.1 Electrical data 13.2 Auxiliary power socket 13.3 Surgical microscope

51 51 51 51

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Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

40 40 40 41 41 41 42

49 50 50

1



14

13.4 Optical data 13.5 Microscope carrier 13.6 Accessories 13.7 Floor stand 13.8 Standards fulfilled 13.9 Environmental conditions 13.10 Limitations of use 13.11 Electromagnetic compatibility (EMC) 13.12 Configurations and Weights 13.13 Dimensional drawing of F20 floor stand 13.14 Dimensional drawing of CT20 ceiling mount

52 52 52 52 52 52 53 53 54 55 56

Annex 14.1 Checklist before the operation

57 57

This manual includes the following systems: • Leica M525 F20 • Leica M525 CT20

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Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

Introduction

1

Introduction

2

1.1

About this user manual

In this user manual the surgical microscope Leica M525 F20/CT20 is described. This user manual contains important safety notes as well as information on using the instrument (see the chapter "Safety notes").

XXBefore setting up the product, carefully read

through the user manual.

1.2

Product Identification

The model code and serial number of your product are provided on the nameplate found on the underside of the horizontal arm. XXCopy this information to the line below so that it is handy in case you have questions for our representatives or service locations. 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.

Symbols in this user manual

The symbols used in this user manual have the following meanings: 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.

XX

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”.

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

3

Safety Notes

3

Safety Notes

3.4

The Leica M525 F20/CT20 surgical microscope is state-of-the-art technology. Nevertheless, hazards may still arise during operation. XXAlways follow the instructions in this user manual, and in particular the safety notes.

Information for the person responsible for the instrument

XXEnsure that the Leica Leica M525 F20/CT20 surgical microscope

is used only by persons qualified to do so. XXThe Leica M525 F20/CT20 surgical microscope may only be

operated by trained personnel.

3.1

Intended use of instrument

• The Leica M525 F20/CT20 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 M525 F20/CT20 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 M525 F20/CT20 surgical microscope's functionality. • The Leica M525 F20/CT20 is intended for professional use only. WARNING

Not suitable for use in ophthalmology!

3.2

Notes on use

• The Leica M525 F20/CT20 surgical microscope mainly used for ENT, Neuro, PRS and Dental surgeries in hospitals, clinics or other human medical institutions. • The Leica M525 F20/CT20 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

The Leica M525 F20/CT20 can NOT be used in Ophthalmology.

4

XXEnsure that this user manual is always available at the place

where the Leica M525 F20/CT20 surgical microscope is in use. XXCarry out regular inspections to make certain that the authorized users are adhering to safety requirements. XXWhen instructing new users, do so thoroughly and explain the meanings of the warning signs and notes. XXAllocate responsibilities for setup, operation and maintenance. Monitor compliance with this. XXOnly use the Leica M525 F20/CT20 surgical microscope if it is free of defects. XXNotify your Leica representative or Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, immediately if you detect a product defect that could potentially cause injury or harm. XXIf you use accessories from other manufacturers with the Leica M525 F20/CT20 surgical microscope, make sure that these manufacturers confirm that the combination is safe to use. Follow the instructions in the user manuals for those accessories. • At the end of its expected service life, dispose of the Leica M525 F20/CT20 according to the national guidelines for waste disposal. • Only the following accessories may be used with the Leica M525 F20/CT20 surgical microscopes: • The Leica Microsystems accessories described in chapter 10.2 in 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 Leica M525 F20/CT20 surgical microscope may be carried out only by technicians who are explicitly authorized by Leica to do so. • Only original parts from Leica Microsystems may be used for maintenance work. • After service work or technical modifications, the device must be readjusted in accordance with our technical regulations. • 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.

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

Safety Notes • The effect of the Leica M525 F20/CT20 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 precautionary and safety measures relating to electromagnetic and other forms of radiation. • The building's electrical wiring must comply with the relevant national standards. We recommend using a current-operated ELCB system (RCB). • Like any other instrument in the operating theater, this system may fail. Leica Microsystems (Schweiz) AG, Medical Division, therefore recommends that a backup system be 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 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 Leica M525 F20/CT20 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 Leica M525 F20/CT20, 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

Instructions for the user

XXFollow the instructions described here. XXFollow the instructions given by your employer regarding the

organization of work and safety at work. XXCheck the illumination intensity before and during surgery. XXDon't move system without released brakes. XXOperate the system only with all equipment in its proper

position (all covers fitted, doors closed). XXMake sure that the ventilation openings are not covered.

Otherwise, the instrument may overheat. 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

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 Leica M525 F20/CT20 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.

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

5

Safety Notes

3.6

Dangers of use

Kippgefahren 3.6.1 Danger of tilting

Never niemals move themit stand with the swing arm Stativ ausgefahrenem Schwenkarm extended. bewegen.

Fahren Sieover niemals über Kabel, diefloor. am Boden Never roll cables lying on the liegen.

Do not allow anyvertikalen vertical orund horizontal forces to Lassen Sie keine horizontalen act on the stand in the position. Position Kräfte auf das Stativ in extended der ausgefahrenen zu.

Fußbremsen schließen, wenn das System Always close immer the footbrakes if the system is not in nicht bewegt wird. motion. Always open immer the footbrakes if the system is in Fußbremsen öffnen, wenn das System motion. wird. bewegt

6

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

Safety Notes WARNING

WARNING

Risk of injury by: • Uncontrolled swinging out of swing arm! • Tilting of the stand! • Feet in non-sturdy shoes may get trapped beneath the base! • Abrupt braking of the surgical microscope at a threshold that cannot be crossed! XXFor transportation, always move the Leica M525 F20 surgical microscope into the transport position. XXNever move the stand while the unit is extended. XXNever roll over cables lying on the floor. XXAlways push the Leica M525 F20 surgical microscope; never pull it.

Failure of the illumination can be dangerous for the patient! XXIf one of the xenon lamps fails, switch to the other one immediately. WARNING Tissue heating! Outside the area visible through the microscope, uncontrolled tissue heating is possible. XXMake sure that the field diameter is not larger than the field of view and the light intensity is not set too high WARNING

Danger of fatal electrical shock! XXThe Leica M525 F20/CT20 surgical microscope may be connected to a grounded safety socket only.

Severe tissue damage can result from an incorrect working distance! XXWhen using lasers, always set the working distance of the microscope to laser distance and lock the microscope in position.

WARNING

WARNING

Danger of tilting if load exceeds permitted load! XXThe load placed on the microscope interface must not exceed 6.5 kg.

Tissue heating! Severe injury to tissue can result from manual adjustment of the working distance! XXDo not adjust the rotary knob for manual setting of the working distance while using the laser.

WARNING

WARNING Risk of injury from downward movement of Leica M525 F20/ CT20 surgical microscope! XXNever change the accessories or attempt to rebalance the microscope while it is above the field of operation. XXAlways balance the Leica M525 F20/CT20 after re-equipping it. XXDo not exceed the max. load when equipping components and accessories. XXDo not release the brakes when the instrument is in an unbalanced state. Improper motions of the stand can result in tilting of the stand. XXObserve notes on danger of tilting on page 6. WARNING Danger of fatal electrical shock! XXThe Leica M525 F20/CT20 surgical microscope may be connected to a grounded safety socket only.

WARNING Risk of infection! XXLeave sufficient space around the stand to ensure that the sterile drape does not come into contact with nonsterile components. WARNING Severe tissue damage can result from an incorrect working distance! XXWhen using lasers, always set the working distance of the microscope to laser distance and lock the microscope in position. WARNING Severe injury to tissue can result from manual adjustment of the working distance! XXDo not adjust the rotary knob for manual setting of the working distance while using the laser.

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

7

Safety Notes WARNING Failure of the zoom or focus motor can be dangerous for the patient! XXIf the zoom or focus motor fails, set the zoom or focus manually. WARNING Risk of injury from downward movement of surgical microscope! XXDo not exceed the max. load when equipping components and accessories. WARNING

Not suitable for use in ophthalmology!

8

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

Safety Notes CAUTION Connecting unauthorized secondary devices to the auxiliary power socket can lead to damage to the surgical microscope and to the secondary device! XXNever connect secondary devices to the auxiliary power socket unless they conform to the specifications. Requirements of use, see chapter 14.5. CAUTION Connecting unauthorized secondary devices to the auxiliary power socket can lead to damage to the Leica M525 F20/CT20 surgical microscope and to the secondary device! XXNever connect secondary devices to the auxiliary power socket unless they conform to the specifications. Requirements of use, see chapter 13.2. CAUTION Surgical microscope can move without warning! XXAlways lock the footbrake when you are not moving the system. CAUTION Burn hazard! The mount of the lighting gets very hot. XXBefore replacing lamps, ensure that the mount has cooled down.

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

9

Safety Notes

3.7

Labels and symbols

Horizontal arm and swing arm F20 4

1 14

5 3

14 15

6

5

14

12 7, 8

2

13

11

9 10

18

19

1

Max. 6.5 kg (14.33 lbs)

2

+ –

3

0 5

17

20

16

21

Max. load for optics carrier

4

Open/Closed

A/B balancing

5

Danger sign for crushing hazard

Scale balancing label 6

DO NOT USE IN OPHTALMOLOGY

10

10

22

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

Not suitable for use in ophthalmology

Safety Notes 7

Danger sign for hot surfaces *

8

Warning signs for lamp replacement *

9

System weight label (F20)

10

Transport position (F20)

19

Potential equalization

20

Note on grounding (United States and Canada only)

21

11

ANVISA Reg. No XXXXXXXXXX

12

13

 Fabrication label     

ANVISA registration number (for Brazil only)

 

   

INMETRO label (for Brazil only)

Lamp 1

Lamp 2

a b c d e f g h

Lamp 1/Lamp 2

14

Danger sign for danger of tilting

15

Rotation range label

16

Caution, follow the User Manual

17

Nameplate (F20)

18

Max. power consumption





Prefix number Leica system article no. Serial number Incremental number starting at 1 for each batch JJ = year (2 digits) MM = month (2 digits) TT = day (2 digits) Production starting date

22

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

MET label

11

Safety Notes Leica M525 CT20 ceiling mount

1

1

12

Nameplate

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

Design

4

Design

4.1

Leica M525 F20 surgical microscope 1

10 2

5

9

8 7

3

4 11 12 13

14 15

6

1 Swing arm 2 Binocular tube 3 Optics carrier 4 Handle 5 Microscope carrier 6 Base 7 Handle 8 Column 9 Control/illumination unit 10 Horizontal arm 11 Power supply 12 Fuse holder (2× 6.3 A, time-lag)

13 Socket for potential equalization For connecting the Leica Leica M525 F20/CT20 to an equipotential bonding device. This is part of the customer's building installation. Observe the requirements of EN 60601-1 (§ 8.6.7). 14 Auxiliary power outlet (max. output power 100 VA) For requirements of use, see chapter 14.5. 15 Fuse holder (1 A, 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! XXNever connect secondary devices to the auxiliary power socket unless they conform to the specifications. Requirements of use, see chapter 14.5.

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

13

Design

4.2

Leica M525/CT20 ceiling mount

8

1

7 5 6

2

4

1 2 3 4 5 6 7 8

14

Swing arm Binocular tube Handle Optics carrier Microscope carrier Control/illumination unit Horizontal arm CT20 ceiling mount

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

3

Function

5

Function

5.1

Balancing system

5.2

The balancing system is used to always balance the Leica M525 F20/ CT20 surgical microscope. All movements that must be carried out during the operation require only minimal force. Two directions of movement, A and B, are balanced on the Leica M525 F20/CT20 surgical microscope.

Brakes

The Leica M525 F20/CT20 surgical microscope has five mechanical brakes that stop the movements of the stand and surgical microscope: In the rotary joint (1) In the microscope carrier (2) At the A/B sledge of the surgical microscope (3) Horizontal arm (4) Horizontal arm near column (5)

1 2

A B

5

4

3

Movement C is balanced out on the microscope carrier.

C

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

15

Function

5.3

Tilt of the microscope carrier

5.4

On the Leica M525 F20/CT20 surgical microscope, the microscope carrier can be tilted within a range between 45° and 70°. The 70° position offers the second surgeon more headroom on the 180° dual stereo attachment. Fastening in the 45° and/or 70° position is done using screws below the cover (1) (see chapter 7.10).

Illumination

The illumination of the Leica M525 F20/CT20 surgical microscope is located in the control/illumination unit (3). It consists of two xenon lamps. If one of the xenon lamps fails, you can toggle to the other xenon lamp using the toggle switch (2).

45ϒ 

2

70ϒ

16

Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

3

Controls

6

Controls

6.1

Leica M525 surgical microscope with microscope carrier 21

1 2

15

10

16

9

3

8

20

19

4

3

7

6

5

18

17

4

1 Rotary knob for manual balancing of the C sledge 2 C sledge 3 Handle clamping lever 4 Handle 5 Optics carrier 6 B sledge 7 A sledge 8 Push button in – direction (optics carrier moves forward) 9 Push button in + direction (optics carrier moves backward) 10 Microscope carrier

Optics carrier (item 5) 15 Push button for reactivating the automatic adjustment of the field diameter 16 Rotary knob for manually changing the field diameter 17 LED for indicating the multifocal focus locking mechanism 18 Button for locking the multifocal focus 19 Rotary knob for manual adjustment of the working distance 20 Display of the working distance 21 Rotary knob for manual setting of magnification (for emergency operation only)

14 11

13

12

Handles (item 4) 11 Zoom 12 Focus 13 ALL FREE button (no braking function, but can be assigned other functions) 14 Selection button (no braking function, but can be assigned other functions) Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01

17

Controls

6.2

Control/illumination unit

1

1 Display 2 Power switch 3 On/off switch for illumination

2

Terminals under the control/illumination unit 5

6

13

12

7

8

7

3 11

10

9

5 Socket for potential equalization For connecting the Leica M525 F20/CT20 to a potential equalization device. This is part of the customer's building installation. Observe the requirements of EN 60601-1 (§ 8.6.7). 6 Power supply connection 7 Fuse holders 8 Auxiliary power outlet (max. output power 100 VA) For requirements of use, see technical data, chapter 13.2. CAUTION Connecting unauthorized secondary devices to the auxiliary power socket can lead to damage to the Leica M525 F20/CT20 surgical microscope and to the secondary device! XXNever connect secondary devices to the auxiliary power socket unless they conform to the specifications. Requirements of use, see chapter 13.2.

4

4 Toggle switch for illuminator 1/2

9 12 V terminal (DC power supply for camera) 10 RS 232 interface (MDRS and Leica service) 11 USB interface (Leica service) 12 CAN-Bus interface 13 Footswitch/handswitch Only footswitches and handswitches delivered by Leica Microsystems (Schweiz) AG, Medical Division, may be connected here. Only systems verified by Leica Microsystems (Schweiz) AG, Medical Division, may be connected to the connections mentioned above.

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Leica M525 F20/CT20 / Ref. 10 715 156 / Version 01