M530 OHX User Manual Ver 04 Aug 2020

 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.

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Leica M530 OHX / Ref. 10 745 219 / Version 04



Contents 1

Introduction 1.1 About this user manual 1.2 Symbols in this user manual 1.3 Optional product features

2 2 2 2

2

Product identification

2

3

Safety notes 3.1 Intended use 3.2 Directions for the person responsible for the instrument 3.3 Directions for the operator of the instrument 3.4 Dangers of use 3.5 Signs and labels

3 3

4

Design 4.1 Leica OHX stand 4.2 Leica M530 Optics carriers

8 8 9

5

Functions 5.1 Balancing system 5.2 Brakes 5.3 Illumination 5.4 Leica Fusion Optics 5.5 Leica SpeedSpot

10 10 11 12 13 13

Controls 6.1 Leica M530 microscope with arm system 6.2 Control unit 6.3 Terminals 6.4 Stand 6.5 Handles 6.6 Footswitch 6.7 Mouthswitch

14 14 16 16 17 17 18 18

Preparation before surgery 7.1 Transportation 7.2 Locking/unlocking the Leica M530 OHX 7.3 Installing optical accessories 7.4 Setting the binocular tube 7.5 Adjusting the eyepiece 7.6 Selecting the assistant 7.7 Stand settings 7.8 Positioning on the operating table 7.9 Attaching sterile controls and drape 7.10 Function check

19 19 20 20 21 21 22 22 27 28 29

6

7

3 3 4 6

8

Operation 8.1 Switching the microscope on 8.2 Positioning the microscope 8.3 Adjusting the microscope 8.4 Transport position 8.5 Shutting down the surgical microscope

30 30 31 31 37 37

9

Control unit with touch panel 9.1 Menu structure 9.2 Selecting users 9.3 Menu – User Settings 9.4 Menu – Maintenance menu 9.5 Menu – "How to..." 9.6 Menu – "Service"

38 38 38 40 47 48 48

10

Accessories

49

11

Care and maintenance 51 11.1 Maintenance instructions 51 11.2 Cleaning the touch panel 51 11.3 Maintenance 51 11.4 Changing bulbs 52 11.5 Notes on reprocessing of resterilizable products 53

12

Disposal

55

13

What to do if ...? 13.1 Malfunctions 13.2 Malfunctions documentation accessories 13.3 Error messages on the control unit

55 55 57 57

14

Specifications 14.1 Electrical data 14.2 Leica M530 14.3 Leica OHX floor stand 14.4 Ambient conditions 14.5 Standards fulfilled 14.6 Limitations of use 14.7 List of weights of balanceable configurations 14.8 Dimensional drawings

58 58 58 61 61 61 62 63 69

15

Manufacturer's declaration of electromagnetic compatibility (EMC) 15.1 Table 1 from EN 60601-1-2 15.2 Table 2 from EN 60601-1-2 15.3 Table 4 from EN 60601-1-2

71 71 72 73

Annex 16.1 Checklist before the operation

74 74

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Leica M530 OHX / Ref. 10 745 219 / Version 04

1

Introduction

1

Introduction

2

1.1

About this user manual

In this user manual the surgical microscopes Leica M530 OHX is described. In addition to notes on the use of the instruments this user manual gives important safety information (see chapter "Safety notes").

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.

...

...

X Read this user manual carefully before operating the

product.

1.2

Symbols in this user manual

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

1.3

Action required; this symbol indicates that you need to perform a specific action or series of actions.

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.

2

Leica M530 OHX / Ref. 10 745 219 / Version 04

Safety notes

3

Safety notes

X If you use accessories from other manufacturers with the

The Leica M530 OHX 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.

3.1

Intended use

• The Leica M530 OHX 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 medical treatment. • The Leica M530 OHX surgical microscope may be used only in closed rooms and must be placed on a solid floor. • The Leica M530 OHX surgical microscope is subject to special precautionary measures for electromagnetic compatibility. It must be installed and commissioned in accordance with the guidelines and manufacturer's declarations and recommended safety distances (according to EMC tables based on EN60601‑1‑2). • Portable and mobile as well as stationary RF communications equipment can have a negative effect on the reliability of the Leica M530 OHX surgical microscope's functionality. • The Leica M530 OHX is intended for professional use only. WARNING Danger of injury to the eyes. X Do not use the Leica M530 OHX in ophthalmology.

3.2

Directions for the person responsible for the instrument

X Ensure that the Leica Leica M530 OHX surgical microscope is

used only by persons qualified to do so. X Ensure that this user manual is always available at the place where the Leica M530 OHX surgical microscope is in use. X Carry out 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 messages. X Allocate responsibilities for commissioning, operation and maintenance. Monitor compliance with this. X Only use the Leica M530 OHX surgical microscope if it is free of defects. X Inform your Leica representative or Leica Microsystems (Schweiz) AG, Medical Division, 9435 Heerbrugg, Switzerland, immediately about any product defect that could potentially cause injury or harm.

Leica M530 OHX 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. • Modifications to or service on the Leica M530 OHX 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 be kept available during the operation

3.3

Directions for the operator of the instrument

X Follow the instructions described here. X Follow the instructions given by your employer regarding the

organization of work and safety at work.

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3

Safety notes

3.4

Dangers of use

WARNING

WARNING Danger of injury to the eyes. X Do not use the Leica M530 OHX in ophthalmology.

Danger of eye injury 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.

WARNING Danger of injury due to: • uncontrolled lateral movement of the arm system • tilting of the stand • feet in lightweight shoes could become trapped beneath the casing of the base X For transportation, always move the Leica M530 OHX surgical microscope into the transport position. X Never move the stand while the unit is extended. X Never roll over cables lying on the floor. X Always push the Leica M530 OHX surgical microscope; never pull it. X Make sure that the movement range is free.

Risk of infection. X Always use the Leica M530 OHX surgical with sterile controls and a sterile drape. WARNING Danger of fatal electrical shock. X The Leica M530 OHX 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

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 Leica M530 OHX. X Balance the Leica M530 OHX 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 intraoperative AC/BC balancing above the patient. X Check fitting and good connection of all parts and cables during the preparation of the system prior to the surgery. Not well fitted parts and bad connections can lead to hazardous situations and system failures.

Danger of eye injury 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.

WARNING Danger of injury due to movement of the microscope during the balancing process. X Do not sit or stand immediately next to the microscope during the balancing process.

4

WARNING

WARNING Danger of burn injuries in otologic surgery. X Use the lowest comfortable light intensity. X Adjust the field of view to match the operating field. X Irrigate the wound frequently. X Cover the exposed parts of the pinna with a moist surgical sponge. WARNING Danger of injury to the eyes. At a short focal distance, the light source of the illumination unit may possibly be too bright for the operating physician and the patient. X Begin with the lower-intensity light source and slowly increase it until the operating physician has an optimally illuminated image.

Leica M530 OHX / Ref. 10 745 219 / Version 04

Safety notes WARNING

CAUTION

Danger to the patient due to failure of the magnification or working distance motor. X If the magnification motor fails, adjust the magnification manually. X If the working distance motor fails, adjust the working distance manually.

Danger to the patient due to changes in the user settings. X Never change the configuration settings or edit the user list during an operation. X Check fitting and good connection of all parts and cables during the preparation of the system prior to the surgery. Not well fitted parts and bad connections can lead to hazardous situations and system failures.

WARNING Danger of serious damage to tissue due to incorrect working distance. X When using lasers, always set the working distance of the microscope to laser distance and lock the microscope in position. X Do not adjust the rotary button for manual setting of the working distance while using the laser.

CAUTION Danger of skin burns. The lamp insert gets very hot. X Check that the cover has cooled before you replace the lamp. X Do not touch the hot lamp insert.

WARNING Danger injury to the eyes due to laser radiation. X Never point the laser directly or indirectly via reflecting surfaces to the eyes. X Never point the laser to the eyes of the patient. X Do not look into the laser beam. CAUTION Surgical microscope can move without warning. X Always lock the footbrake when you are not moving the system. CAUTION Risk of infection. X Leave sufficient space around the stand to ensure that the sterile drape does not come into contact with nonsterile components. CAUTION If the field diameter is greater than the field of view and the light intensity is too high, uncontrolled tissue heating may occur outside of the area visible through the microscope. X Do not set the light intensity too high.

Leica M530 OHX / Ref. 10 745 219 / Version 04

5

Safety notes

3.5

Signs and labels

18

1

2 3

16

14 12

13

4 5

17

11

6

8 9

15 10

6

7

Leica M530 OHX / Ref. 10 745 219 / Version 04

19

Safety notes 1

DO NOT USE IN OPHTHALMOLOGY

Contraindication

10

INMETRO label (only brazil)

11

Equipotential bonding

NE PAS UTILISER EN OPHTHALMOLOGIE

2

Locked/Free

3

Danger sign for squeezing hazard

12

NAV

13

Fabr. Nr.

14 4

MET Label

5

Follow the User Manual.

6

System weight label

Medical device 15



7

RISK GROUP 3

Warning of XENON light emission

WARNING IR emitting from this product. Do not look at operating lamp.

NOTICE UV emitted from this product. Minimise exposure to eyes or skin. Use appropriate shielding.

9

LAMP 2

LAMP 1

Grounding reliability can only be achieved when EQUIPMENT is connected to equivalent receptacle marked "Hospital only" or "Hospital Grade".

Grounding label (only USA and Canada)

La fiabilité de la mise à la terre n’est assurée que si l’équipement est connecté à une prise équivalente, marquée «Hôpital seulement» ou «Qualité hôpital».

WARNING Possibly hazardous optical radiation emitted from this product. Do not look at operating lamp. Eye injury may result.

8

Type label

Lamp number with danger sign for hot surface

16

Laser label

17

Warning trained personnel

18

Monitor arm weight label

19

Warning use Xenon Bulbs

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7

Design

4

Design

4.1

Leica OHX stand

2

1

14

3 13 8

4

12 11

7 6

5

10

1 Leica M530 optics carrier 2 Arm system 3 Tension rod 4 Control unit with touch panel 5 Footbrake 6 Base 7 Suspension device for footswitch 8 Video monitor (optional) 9 Vertical arm 10 Illumination unit 11 Terminals 12 Camera and recording unit (optional) 13 Handle 14 Monitor arm With its open architecture the Leica M530 OHX provides space for holding the camera and recording units.

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9

Design

4.2

Leica M530 Optics carriers

4.2.1

Leica M530 with Top plate

Leica M530 with ULT530

• Optics carrier with integrated camera for visible light Leica HD C100 (optional) • Interface for assistants, either to the left and right side or to the back • Main surgeon and back assistant interface, 360° rotatable both • Back assistant interface with fine focus knob • For use with Image Injection Module Leica CaptiView

• Basic optics carrier

4.2.2

4.2.3

Leica M530 with IVA530

4.2.4

Leica M530 with Leica FL800 ULT/ GLOW800

• Optics carrier with integrated C-mount video adapter for installing a camera • Assistant interface, switchable either to the left or to the right side • Optics carrier with integrated camera for visible light Leica HD C100 (optional) • Interface for assistants, either to the left and right side or to the back • Main surgeon and back assistant interface, 360° rotatable both • Back assistant interface with fine focus knob • Leica FL800 ULT/GLOW800 system components built into the common housing of the ULT • For use with Image Injection Module Leica CaptiView

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9

Functions

4.2.5

Leica M530 with Leica FL400 for M530 / Leica FL560 for M530 / Leica FL800 ULT / GLOW800

5

Functions

5.1

Balancing system

With a balanced surgical microscope Leica M530 OHX you can move the optics carrier in any position without tilting or falling down. After balancing all movements during operation only need a minor force.

5.1.1

Balancing the optics carrier

On the optics carrier Leica M530 two directions of movement are balanced: A and B.

• Optics carrier with integrated camera for visible light Leica HD C100 (optional) • Interface for assistants, either to the left and right side or to the back • Main surgeon and back assistant interface, 360° rotatable both • Back assistant interface with fine focus knob • Fluorescence observation filter module (Leica FL400 for M530 / Leica FL560 for M530) • Leica FL800 ULT system components built into the common housing of the ULT • For use with Image Injection Module Leica CaptiView The CaptiView, FL400, FL560 and FL800 ULT functions are described in the corresponding user manuals.

B

A

The optics carrier can be balanced in the A/B direction until up to the 20° options . The essential performance of the Leica M530 OHX is providing sufficient light to the situs and to guarantee mechanical locking of the optics carrier in any possible positioning.

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Leica M530 OHX / Ref. 10 745 219 / Version 04

Functions

5.1.2

5.2

Balancing the arm system

On the arm system the direction of movement C is balanced.

C

Brakes The Leica M530 OHX may be moved only with released brakes. X Do not perform any movements when the brakes are locked.

The Leica M530 OHX surgical microscope has 6 electromagnetic brakes which stop the movements of the stand and surgical microscope:

4 5

C

6 3

5.1.3

Balancing the parallelogram

2

The parallelogramm balances the up/down movement (direction D). 1

1 2 3 4 5 6 D

Foot Up/down in parallelogram Forward/back in parallelogram In the rotary joint In arm system On the A and B sledges of surgical microscope

Brakes are operated via the handle. The button of the handle with the assigned function "Selected Brakes" (refer also to the chapter on "Assigning handles", page 44) can trigger two different brake combinations: "Focus Lock" or "XYZ Free".

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11

Functions

5.2.1

5.3

Selected Brakes – XYZ Free

The following movements can be performed with the surgical microscope when the brake combination "XYZ Free" is activated:

Illumination

The illumination of the surgical microscope Leica M530 is a xenon lamp and is located in the stand. Illumination is routed to the optics carrier via fibre optic light guide. There are two identical lamps. In case of a failure of the lamp in use, the other lamp can be selected, either on the touchscreen or manually.

5.3.1

AutoIris

AutoIris synchronizes the illumination field automatically according to the magnification factor. Using the manual override, the illumination field can be adjusted manually.

5.3.2

5.2.2

Selected Brakes – Focus Lock

The following movements can be performed with the surgical microscope when the brake combination "Focus Lock" is activated:

BrightCare Plus

BrightCare Plus is a safety function which automatically limits the maximum brightness depending on the working distance. Excessively bright light can, in combination with a short working distance, cause burns in patients. When shipped from the factory, the "BrightCare Plus" safety function is activated for all users. Luminous energy The optics of the Leica Leica M530 OHX surgical microscope have a variable working distance of between 225 and 600 mm. The system is designed in such a way that it delivers sufficient light to produce a bright image even at a long working distance of 600 mm. In accordance with the formula Ev=Iv/d2, the light quantity continually increases by 710 % when the working distance is changed from 600 to 225 mm. (Ev = light intensity, Iv= brightness, d= distance from light source). This means that less light is required to work with the microscope at a shorter distance than at a greater distance.

It is advisable to begin with a low light intensity and increase it until an optimum level of illumination is achieved. Heat release Heat from non-visible light (over 700 nm) is filtered out of the light from the used xenon light source. Nevertheless, white light also always develops heat. An excessive amount of white light can lead to overheating of tissue and metal objects.

It is advisable to begin with a low light intensity and increase it until an optimum level of illumination is achieved.

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Leica M530 OHX / Ref. 10 745 219 / Version 04

Functions

5.5

BrightCare Plus display

Leica SpeedSpot

Leica M530 is equipped with the Laser focussing aid Leica SpeedSpot. If Leica SpeedSpot is activated for the current user (see page 45), the focussing aid is released when the brakes are released or when focussing. Two convergent light beams meet exactly in the focussing point of the microscope.

When BrightCare Plus is activated, the red line on the brightness adjustment bar shows the maximum adjustable brightness for the current working distance. The brightness cannot be set to a level beyond the red line unless the BrightCare Plus function is intentionally deactivated. When the working distance is reduced too much at a set brightness, the brightness is reduced automatically.

5.4

Exit of the laser beams

Leica Fusion Optics

This feature provides an augmentation in resolution and depth of field for an ideal 3-D optical image. Leica FusionOptics operates with two separate beam paths with different information: the left beam path is optimized for high resolution, the right beam path for optimum depth of field. The human brain merges these two very different images to a single, optimal spatial image.

Laser Course of the laser beams

Laser

Leica M530 OHX / Ref. 10 745 219 / Version 04

13

Controls

6

Controls

6.1

Leica M530 microscope with arm system

6.1.1

Surgeon panel

1 2

1

3 4 5

2

6

3

4 5

9

6 6

9 10

8 7

1 2 3 4 5 6

Magnification Working distance Brightness FL mode Recording status Manual balancing

6.1.2

Locks

1 C sledge 2 Surgeon panel 3 Microscope carrier 4 B sledge 5 A sledge 6 Handle 7 Display of set working distance and magnification 8 Leica M530 surgical microscope 9 Handle clamping lever 10 Push button for intraoperative AC/BC balancing (not available for Japan)

1

2

1 Locking in horizontal direction 2 Locking in vertical direction 14

Leica M530 OHX / Ref. 10 745 219 / Version 04

Controls

6.1.3

Optics carrier – rear

6.1.4

Leica M530 with Top plate / Leica M530 with IVA530

Optics carrier – controls

Leica M530 with Top plate / Leica M530 with IVA530

6 9 1

5

2 1 2 4

Leica M530 with ULT530 and Leica FL800 ULT or with Leica FL400 for M530 / Leica FL560 for M530

32 1

Leica M530 with ULT530 and Leica FL400 for M530 / Leica M560 for M530 or with Leica FL800 ULT 7

8

6 9 5

2 4

1 CAN socket (Leica M530 with Top plate and IVA530 only) 2 Optical fiber connection

1 2 3 4 5 6 7 8 9

321

Button "Focus lock" (counter-sunk) LED Focus lock active Receiver Remote Control Camera Rotary knob "Working distance" (emergency operation only) Rotary knob "Manual override AutoIris" Rotary knob "Magnification" (emergency operation only) Assistant back/side Fine focus back assistant Button "Reset AutoIris"

Leica M530 OHX / Ref. 10 745 219 / Version 04

15

Controls

6.3

Leica M530 with IVA530

Terminals NAV

LAN USB ADF

10

XGA IN CAN DVI out Video out Foot Switch

10 Assistant right/left

6.2

Control unit

1 2 3

LAN USB1/2 AD.F. XGA in CAN DVI out Video out NAV

to connect to Dicom * e.g. for upgrades Additional Function to connect an external video source ** to connect CAN devices ** to connect an external monitor to connect an external monitor to connect a navigation system

* May not be used during surgery ** Connect medical equipment only

1 Touch panel 2 Push-button with illumination LED (On/Off) 3 Push-button with illumination LED for Auto Balance

16

Leica M530 OHX / Ref. 10 745 219 / Version 04

Controls

6.4

Stand

You can assign switches 1, 2, 3 and 5 of the handles individually for each user in the configuration menu. In all presets, key (4) releases all brakes. This key cannot be configured. For the joystick and the other keys presets are available according to your task.

6.5.1

1 2

Handles – Joystick

Power

L2

L1

3 4

Y+

Y+

5

1 Equipotential bonding socket For connecting the Leica Leica M530 OHX to an equipotential bonding device. This is part of the customer's building installation. Observe the requirements of EN 60601-1 (§ 8.6.7). 2 Main switch for Leica M530 OHX surgical microscope with integrated circuit breaker 3 Power input 4 Access door illumination unit 5 Illumination switch (lamp 1 / lamp 2) The Leica M530 OHX surgical microscope has a primary illumination source and an equivalent standby illumination source.

6.5

Presets for Cranial / Spinal / ENT

X–

X+

Y–

X+

Y–

Handles – Buttons

1

2

1

3

Handles 1 Magnification 2 Working distance 3 Release preselected brakes

2 2

1

X–

3 4

5

4 1

Assignment in the factory setting 1 Magnification 2 4-function joystick 3 Working distance 4 Release all brakes 5 Release preselected brakes

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17

Controls

6.6

Footswitch

This is an overview of all possible footswitches you can use to control your Leica M530 OHX surgical microscope. Footswitch • 12 functions • crosswise

• Footswitches can be assigned individually for each user in the configuration menu.

6.6.1

Presets for Cranial / Spinal / ENT

Footswitch • 16 functions • crosswise

Y+ X– No function Working distance (Focus) +

Magnifiction + No function

Footswitch • 12 functions • lengthwise

Footswitch • 16 functions • lengthwise

6.7

X+ Y–

No function Working distance (Focus) –

Magnification – No function

Mouthswitch

1

Footswitch • 12 functions • crosswise

18

Footswitch • 14 functions • crosswise

1 Release "XYZ Free" brakes

Leica M530 OHX / Ref. 10 745 219 / Version 04