Heads-up Microsurgery User and Installation Manual Ver 00 June 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 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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Contents 1

Introduction 1.1 About this user manual 1.2 Nomenclature 1.3 Symbols in this user manual

2 2 2 2

2

Product identification

2

3

Safety notes 3 3.1 Intended use 3 3.2 Contraindications for use 3 3.3 Dangers of use 3 3.4 Directions for the use of the system combination 3

4

System combination 4.1 GLOW800 4.2 LMD-X310MT / LMD-X550MT 4.3 Heads-up kit Microsurgery

4 4 4 4

5

Installation

5

6

Operation

6

7

Specifications

6

8

What to do if..? 8.1 Before surgery 8.2 During surgery 8.3 Malfunctions of the particular systems 8.4 Recover correct monitor settings

7 7 7 7 8

9

Care and maintenance 9.1 Maintenance instructions

9 9

10

Manufacturer's declaration of electromagnetic compatibility (EMC) 10.1 Table 1 from EN 60601-1-2:2015 10.2 Table 2 from EN 60601-1-2:2015 10.3 Table 4 from EN 60601-1-2:2015

10 10 11 12

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1

Introduction

1

Introduction

2

1.1

About this user manual

The option for performing heads-up microsurgery is based on the system combination of the GLOW800 accessory for Leica surgical microscopes and the Sony monitors LMD-X310MT or LMD-X550MT. In this user manual the functions of the system combination are described. For information, description, specification and compliance to standards of the GLOW 800, the Leica surgical microscope or the Sony monitors LMD-X310MT and LMD-X550MT, please refer to the user manuals of the particular systems.

Product identification

The model and serial numbers of your products are located in the identification label on your device. XXEnter 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.

...

...

In addition to notes on the use of the instruments this user manual gives important safety information (see chapter "Safety notes").

XXRead this user manual carefully before operating the

product.

1.2

Nomenclature

In the following, the term “heads-up monitor” refers to the monitors listed in the intended use.

1.3

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.

XX

2

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

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Safety notes

3

Safety notes

3.4

The Heads-up Microsurgery is state-of-the-art technology. Nevertheless, hazards can arise during operation. XXAlways follow the instructions in this user manual, and in particular the safety notes.

3.1

Intended use

Directions for the use of the system combination

• For best performance, do not change the settings of the headsup monitor. • When performing heads-up surgery always keep the binocular tubes for the main surgeon mounted on the microscope and ready for use. In case of image loss on the heads-up monitor the surgery can always be completed by using the binocular tubes.

• The following Surgical Microscope Systems are intended to be used as optical instrument for improving the visibility of objects through magnification and illumination. The systems can be applied for observation and documentation and for human and medical treatment: OHX/OH6/ARveo equipped with GLOW800 in combination with a Sony LMD-X310MT / LMD-X550MT monitor and the Heads-up kit microsurgery

3.2

Contraindications for use

Heads-up microsurgery is not intended to be used during activated fluorescence modes of GLOW800, FL400 and FL560.

3.3

Dangers of use Warning Danger of injury to the user XXDo not place the cable between the monitor and the Leica surgical microscope where persons in the operating room can trip over it. Warning Danger of injury to the patient due to use in fluorescence mode XXDo not perform heads-up surgery during activated fluorescence modes of GLOW800, FL400 and FL560. Warning Loss of image on heads-up monitor XXDo not use a wireless connection between the microscope and the heads-up monitor for image transfer.

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3

System combination

4

System combination ARveo

M530 OHX

M530 OH6

4.1

GLOW800

The GLOW800 is a Leica surgical microscope accessory used in viewing intra-operative blood flow. When not in fluorescence mode, the GLOW800 provides two video signals that display the real-time image of the left and the right beam path of the microscope.

4.2

LMD-X310MT / LMD-X550MT

The LCD Monitor is intended to provide 4K, 3D and 2D color video displays of images from endoscopic/laparoscopic camera systems, surgical microscope and other compatible medical imaging systems. The LCD-Monitor is a widescreen, high definition, medical grade monitor for real-time use during surgical procedures and is suitable for use in hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments. In the following, the Sony monitors LMD-X310MT and LMD-X550MT are referred to as heads-up monitor.

4.3

Heads-up kit Microsurgery

The heads-up kit microsurgery is a set of cables that enables the system combination of GLOW800 (chapter 4.1) and the LCD monitors (chapter 4.2).

4

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Installation

5

Installation

Check performance of the system

How to set up heads-up microsurgery: XXConnect power to the Leica Surgical Microscope and switch it on. XXConnect the two SDI cables that are connected to the monitor to the GLOW800 faceplate.

XXCheck that an image is displayed. XXCheck for correct 3D image by placing a slim 3-dimensional

object in front of the microscope (e.g. a blade). XXAssess on the heads-up monitor that the left eye sees the left

face of the object and the right eye sees the right face. Position of the monitor

The monitor shall be positioned such that the surgeon has an unobstructed view and that the surface of the monitor is perpendicular to the line of sight of the surgeon.

Warning Danger of injury to the user XXDo not place the cable between the monitor and the Leica surgical microscope where persons in the operating room can trip over it.

1

1

1 Possible monitor positions

Warning Loss of image on heads-up monitor XXDo not use a wireless connection between the microscope and the heads-up monitor for image transfer. XXConnect power (2) to the monitor and switch it on.

2 1

1 Y-cable (red & white) for 3D signal 2 Power for Monitor

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5

Operation

6

Operation

7

When GLOW800 and the heads-up monitors are connected, the surgeon can perform surgery by looking at the heads-up monitor. Warning Danger of injury to the patient due to use in fluorescence mode XXDo not perform heads-up surgery during activated fluorescence modes of GLOW800, FL400 and FL560.

Specifications

For specifications of the Leica Surgical Microscope, for GLOW800 and for the Sony monitors please refer to the user manuals of the particular systems and the system sheets Leica M530 OH6/ARveo and Leica M530 OHX.

Loss of heads-up monitor settings XXDo not change the settings of the heads-up monitor. Surgeon unable to perceive 3D image from a monitor XXBefore performing heads-up surgery from a monitor for the first time, every surgeon must check whether he can perceive 3D vision from the heads-up monitor. Ensure a pre-operational check before using the system XXBefore using the system like intended to perform headsup surgery from a monitor, every surgeon must check whether he can perceive 3D vision from the heads-up monitor in the correct way. Monitor settings must remain unchanged by the user XXThe monitor settings set to the system received are predefined to the best possible performance. Therefore the settings of the monitor must remain unchanged. User has to wear with the system provided 3D goggles only The monitor comes with 3D goggles. XXUser must ensure to use only these 3D goggles to ensure the best possible performance and acceptance of the 3D images displayed on the monitor.

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What to do if..?

8

What to do if..?

8.1

Before surgery

Ensure a pre-operational check before using the system

Before using the system like intended to perform heads-up surgery from a monitor, every surgeon must check whether he can perceive 3D vision from the heads-up monitor in the correct way. If the image on the heads-up monitor is lost before or during surgery, the surgeon can always perform surgery by using the binocular tubes that are required be mounted on the microscope. If electrically operated functions do not work properly, always check these points first: • Is the power switch on the microscope and heads-up monitor switched on? • Are the power cables attached correctly? • Are all video cables attached correctly? If all connections and power states are checked, please consider the following steps Malfunction

Cause

Remedy

No Image on the monitor

Monitor is set incorrectly

Set monitor correctly (see below)

Image is not in 3D

Monitor is set incorrectly

Set monitor correctly (see below)

Impression of blurred or double-image

User is not wearing 3D glasses

User must wear 3D glasses to obtain correct 3D vision

3D impression is “twisted” / image is “distorted” Left and right video cable are connected incorrectly

Connect the video cables correctly (see chapter “installation”)

3D impression is insufficient

Rotate and tilt the monitor so that the surgeon’s line of sight is perpendicular to the monitor surface

8.2

Surgeon’s viewing angle is not perpendicular to the monitor

During surgery

If the image on the heads-up monitor is lost during surgery, the surgeon can always perform surgery by using the binocular tubes that are required be mounted on the microscope.

8.3

Malfunctions of the particular systems

For malfunctions regarding the Leica surgical microscope, GLOW800 and the heads-up monitor please refer to the user manuals of the particular systems and the system sheets Leica M530 OH6/ARveo and Leica M530 OHX.

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7

What to do if..?

8.4

Recover correct monitor settings

XXUnlock the controls if locked.

XXReset to factory settings.

XXActivate PORT A, check if this resolves the malfunction.

Should any custom settings have been made intentionally, these will be lost through this step. XXIf you want to keep such settings, omit this step. XXRe-Lock the controls.

XXPress 2D/3D button until the monitor is in 3D mode, check if this

resolves the malfunction.

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Care and maintenance

9

Care and maintenance

9.1

Maintenance instructions

XXKeep accessories in a dust-free place when not in use. XXRemove dust with a pneumatic rubber pump and a soft brush. XXProtect the devices from damp, vapors, acids, alkalis, and

corrosive substances. XXDo not keep chemicals near the devices. XXProtect the devices from oil and grease. XXNever oil or grease the guide surfaces or mechanical parts. XXTo disinfect the camera system, use compounds from the

surface disinfectant group based on the following active ingredients: • Aldehydes • Alcohols • Quaternary ammonium compounds Due to potential damage to the materials, never use products based on: • Halogen-splitting compounds • Strong organic acids • Oxygen-splitting compounds. XXFollow the disinfectant manufacturer's instructions. • We recommend concluding a service contract with Leica Service.

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Manufacturer's declaration of electromagnetic compatibility (EMC)

10 Manufacturer's declaration of electromagnetic compatibility (EMC) 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. This "Guidance and manufacturer's declaration" document is based on EN 60601-1-2:20015.

10.1 Table 1 from EN 60601-1-2:2015 Guidance and manufacturer's declaration – electromagnetic emissions The Heads-up for Microsurgery devices are intended for operation in an environment as specified below. The customer or the user of the devices should make sure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment – guidance

RF emissions in accordance with CISPR 11

Group 1

The Heads-up Microsurgery devices use RF energy only for their internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Conducted emissions in accordance with CISPR 11

Class A

Harmonic emissions according to IEC 61000-3-2

Class A

Emission of voltage fluctuations/flicker according to IEC 61000-3-3

Complies

The Heads-up Microsurgery devices are suitable for use in establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for residential purposes.

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Manufacturer's declaration of electromagnetic compatibility (EMC)

10.2 Table 2 from EN 60601-1-2:2015 Guidance and manufacturer's declaration – electromagnetic emissions The Heads-up for Microsurgery devices are intended for operation in an environment as specified below. The customer or the user of the devices should make sure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance

Discharge of static electricity (ESD) according to IEC 61000-4-2

± 8 kV contact discharge

± 8 kV contact discharge

± 15 kV air discharge

± 15 kV air discharge

Floors should be of wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/ burst immunity according to IEC 61000‑4-4

± 2 kV for power supply line

± 2 kV for power supply line

± 1 kV for input and output lines

± 1 kV for input and output lines

Surges according to IEC 61000-4-5

± 1 kV differential mode

± 1 kV differential mode

± 2 kV common mode

± 2 kV common mode

<5 % UT (>95 % dip in UT) for ½ cycle

70% UT 25/30 cycles

Voltage dips, short interruptions and power supply voltage fluctuations IEC 61000-4-11

40 % UT (60 % dip in UT) for 5 cycles 70 % UT (30 % dip in UT) for 25 cycles

40% UT 10/12 cycles 40% UT 5/6 cycles 0% UT

0.5/0.5 cycles

0% UT

1/1 cycles

<5 % UT (>95 % dip in UT) for 5 sec

0% UT

250/300 cycles

Magnetic fields at mains frequency (50/60 Hz) according to IEC 61000-4-8

3 A/m

30 A/m

Note

UT is the AC voltage prior to application of the test level.

Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Heads-up Microsurgery surgical microscope requires that the instrument remain functional even after power interruptions, it is recommended that the Heads-up Microsurgery devices are provided with an auxiliary power source such as an uninterruptible power supply (UPS) or battery back-up.

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11

Manufacturer's declaration of electromagnetic compatibility (EMC)

10.3 Table 4 from EN 60601-1-2:2015 Guidance and manufacturer's declaration – electromagnetic immunity The Heads-up for Microsurgery devices are intended for operation in an environment as specified below. The customer or the user of the devices should make sure that it is used in such an environment. Immunity test

IEC 60601 test level

Compliance level

Electromagnetic environment – guidance Portable and mobile RF communications should be used no closer to any part of the Heads-up Microsurgery devices, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance

Radiated RF - Disturbance 3 V/m variables according to 80 MHz to 2.7 GHz IEC 61000-4-3

10 V/m 80 MHz to 3 GHz

Conducted RF Disturbance variables according to IEC 61000-4-6

10 Veff

3/6 Veff 150 kHz to 80 MHz

d = 0.35 √P for 150 kHz to 80 MHz d = 0.35 √P for 80 MHz to 800 MHz d = 0.7 √P for 800 MHz to 2.7 GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range. Interference may occur in the vicinity of equipment marked with the following symbol:

Proximity fields

Note 1

At 80 MHz, the higher frequency range applies.

Note 2

These guidelines may not apply in all situations. Electromagnetic propagation amount is affected by absorption and reflection from structures, objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Heads-up Microsurgery devices are used exceed the applicable RF compliance level above, the Heads-up Microsurgery devices should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Heads-up Microsurgery devices.

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Manufacturer's declaration of electromagnetic compatibility (EMC) Recommend separation distances between portable and mobile RF telecommunications equipment and the Heads-up Microsurgery surgical microscope The Heads-up for Microsurgery devices are intended for operation in an electromagnetic environment in which radiated RF interference is controlled. The customer or user of the devices can help prevent electromagnetic interference by maintaining the minimum distance between portable/mobile RF communication equipment (transmitters) and the Heads-up for microsurgery devices, depending on the output power of the communication equipment, as stated below. Separation distance according to frequency of transmitter in m

150 kHz up to 80 MHz

80 MHz up to 800 MHz

800 MHz up to 2.5 GHz

d = 2.4 √P in m

d = 2.4 √P in m

d = 2.4 √P in m

0.01

0.24

0.24

0.24

0.1

0.8

0.8

0.8

1

2.4

2.4

2.4

10

8.0

8.0

8.0

100

24.0

24.0

24.0

Rated maximum output power of transmitter in W

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note 1 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

If use is made of accessories or cables other than those specified in this user manual or approved by the manufacturer of the Heads-up Microsurgery devices, this can lead to an increase in electromagnetic radiation or a reduction in EMC. The Heads-up Microsurgery devices must not be used directly adjacent other instruments. If it is necessary to operate it in the vicinity of other instruments, the devices should be monitored to ensure that they function properly in this arrangement.

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Innovations for your practice From the first surgical microscope with widefield optics in the 1980s to the first microscopes with Horizontal Optics and with LeD illumination, Leica Microsystems has been at the forefront of innovation in the development of surgical microscopes. HD video, fluorescence and retinal viewing systems also demonstrate the continued innovative nature of the Leica team. We strive to provide the surgeon with leading edge technology to enhance performance, surgeon comfort, and patient outcomes.

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10 747 501en/00 •Copyright © by Leica Microsystems (Schweiz) AG, Medical Division, CH-9435 Heerbrugg, 2018• Printed – 06.2018• Subject to modifications • LEICA and the Leica Logo are registered trademarks of Leica Microsystems