KICK System User Guide Rev 1.0 June 2015

TABLE OF CONTENTS

TABLE OF CONTENTS GENERAL INFORMATION ...7 Contact Data and Legal Information ...7 Legal Information ...9

Symbols ...10 Hardware Symbols...11

Intended Use ...14 Compatibility with Medical Devices ...16 Training and Documentation ...17 Documentation...18

SYSTEM OVERVIEW ...19 System Components ...19 System Setup ...21 Kick System ...22 OR Setups ...23

Proper System Handling ...24 Inspections ...27 Weekly and Monthly Inspections ...28 Annual Electrical Safety Inspection ...29

Malfunctions and Return Instructions ...30 Return Instructions ...31

MONITOR CART ...33 Components ...33 Monitor ...35 Range of Motion...37 Moving Parts ...38

Monitor Cart Ventilation ...39 3rd-Party Connections ...40 Back Panel Connections ...42

Cabling ...43 Cable Storage ...46

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TABLE OF CONTENTS

LED Indications ...47

CAMERA CART ...49 Cart Components ...49 Camera ...51

Cabling ...52 Camera Use ...54 Range of Motion...56 Operating Position ...57 Adjusting Camera Cart...58

LEDs and Acoustic Signals ...62

USING THE SYSTEM ...65 Turning System On ...65 System Shutdown ...66 Sterile Use ...67 Sterile Touchpen ...70

ASSEMBLY, TRANSPORT AND STORAGE ...73 Protection Covers ...73 Transport Outside of the Hospital ...75 Assembling the Camera Cart ...77 Assembling the Monitor Cart ...80 Disassembling the Kick System ...83

Transport Inside the Hospital ...85 Proper Transport Procedure...86

Parking and Storage ...88 Parking Carts ...89 Storage ...90 Long Term Storage ...91

CLEANING ...93 Cleaning the System ...93 Cleaning the Kick System ...95

Protection Covers ...97 Protection Cover for Camera...98

Transport Cases ...99

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TABLE OF CONTENTS

INDEX ...101

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TABLE OF CONTENTS

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GENERAL INFORMATION

1

GENERAL INFORMATION

1.1

Contact Data and Legal Information

Manufacturer This product is manufactured by Brainlab and exclusively distributed by DePuy Synthes. Brainlab AG Kapellenstr. 12 85622 Feldkirchen Germany

Distributor DePuy Synthes Sales, Inc. 325 Paramount Drive Raynham, MA 02767 USA

Support If you cannot find information you need in this guide, or if you have questions or problems, contact support: Region

Telephone and Fax

United States, Canada, Central and South AmeriTel: +1 (866) 473 7823 ca Europe, Middle East, Africa

Tel: +32 2 352 16 66

Asia, Australia

Tel: +65 6827 6154

Support and service of the system may be done either by Brainlab service and support personnel or personnel of third parties certified or authorized by Brainlab. Within this manual, both possibilities are included when Brainlab support or service is mentioned.

Expected Service Life Brainlab provides a minimum of eight years of service for platforms. During this period of time, spare parts as well as field support are offered. The Kick system lifetime is dependent on factors such as method and duration of each use, and handling between uses. Careful functional testing and inspection of the Kick system before use is the best method for determining the end of lifetime. The end of lifetime is normally determined by wear and tear damage due to use. As part of preventive service, follow the maintenance instructions.

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Contact Data and Legal Information

Feedback Despite careful review, this manual may contain errors. Please contact us at [email protected] if you have suggestions as to how we can improve this manual.

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GENERAL INFORMATION

1.1.1

Legal Information

Copyright This guide contains proprietary information protected by copyright. No part of this guide may be reproduced or translated without express written permission of Brainlab.

Brainlab Trademarks • Kick® is a trademark of Brainlab AG in Germany and/or the US.

CE Label • The CE label shows that the Brainlab product complies with the essential requirements of Council Directive 93/42/EEC (the "MDD"). • According to the principles set out in the MDD, Kick is a Class IIb product. NOTE: The validity of the CE label can only be confirmed for products manufactured by Brainlab.

Disposal Instructions Only dispose of electrical and electronic equipment in accordance with statutory regulations. For information regarding the WEEE (Waste Electrical and Electronic Equipment) directive, visit: http://www.brainlab.com/weee For more information or recycling instructions, please contact Brainlab.

Sales in the US US federal law restricts this device to sale by or on the order of a physician.

Federal Communications Commission (FCC) Statement This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at their expense. Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. The WLAN module included in this product cannot be accessed by end users. The FCC ID of the WLAN module is listed on the WLAN label attached to the Monitor Cart. Please contact Brainlab Support in case of any related questions.

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Symbols

1.2

Symbols

Warnings Warnings are indicated by triangular warning symbols. They contain safety-critical information regarding possible injury, death or other serious consequences associated with equipment misuse.

Cautions Cautions are indicated by circular caution symbols. They contain safety-critical information regarding possible problems with the device. Such problems include device malfunctions, device failure, damage to device or damage to property.

Notes NOTE: Notes are formatted in italic type and indicate additional useful hints.

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GENERAL INFORMATION

1.2.1

Hardware Symbols

Symbols on Hardware Components The following symbols may be found on the system: Symbol

Explanation Type BF Applied Part according to IEC 60601-1

Caution

Potential equalization point

Do not reuse

Non-sterile

Do not resterilize

Sterilized with ethylene oxide

Do not use if packaging is damaged

Keep away from sunlight

Keep dry

Storage conditions for temperature: The specified temperature range is shown on each label.

Storage conditions for relative humidity non-condensing: The specified humidity range is shown on each label.

Storage conditions for air pressure: The specified air pressure range is shown on each label.

Radio device

Class 2 wireless LAN

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Symbols

Symbol

Explanation Quantity of products in packaging

Batch number

Serial Number

Article number

Use by month YYYY

Date of manufacture

Manufacturer

Authorized representative in the European Community

IPXY

Ingress Protection according to IEC 60529 • X = Protection against ingress of solid objects • Y = Protection against ingress of liquid Strong magnetic field

Danger of clamping hand or other body parts in equipment

Do not look directly into the laser beam or point laser beam into the patient’s face or eyes Laser radiation emitted from aperture Do not stare into beam Class 2 laser product max. output 1mW wavelength 635 nm Danger of tilting: Do not move system when brakes are locked or if device is blocked by obstacles

Standby switch to bring the device into standby mode.

Consult the operating instructions

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GENERAL INFORMATION

Symbol

Explanation

Consult accompanying documentation

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Intended Use

1.3

Intended Use

Intended System Use The Kick system is a navigation platform used for Image Guided Surgery (IGS) incorporating: • A tracking system • A computer unit that runs the software • A display unit to display the navigation, including touch functionality for the user to interact with the software.

Place of Use The system is only for use indoors, in a hospital operating room.

Frequency of Use The frequency of use is defined to be between once per month and several times per week.

Patient Population The patient population consists of patients that could be treated via Brainlab application software that are released for this Image Guided Surgery (IGS) device. For details refer to the relevant Software User Guide.

Intended User Profile The following describes the intended users of the system and their respective tasks: • Trained hospital personnel (e.g., nurses) are responsible for setting up the system before the surgical procedure and for removing the system after the surgical procedure. - System setup and removal includes: moving and positioning, plugging cables in/out, startup/ shutdown, cleaning of the system, connecting/disconnecting 3rd party devices. • Sterile nurse is responsible for maintaining sterility during surgery, including the draping of devices. • Surgeons and/or surgical assistants steer and interact with the Brainlab software running on the system using the system touchscreen. For detailed information on use of the software, see the relevant Software User Guide. • Brainlab authorized personnel are responsible for system maintenance and support.

Essential Performance As essential performance is defined by the clinical function(s), it is dependent on the Brainlab application used and the clinical procedure. Consult the corresponding Software User Guide to see if an essential performance is defined, and if so, which essential performance.

Careful Hardware Handling Only trained medical personnel may operate system components and accessory instrumentation. System components and accessory instrumentation comprise precise mechanical parts. Handle them carefully.

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GENERAL INFORMATION

Plausibility Review Before patient treatment, review the plausibility of all information input to and output from the system.

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Compatibility with Medical Devices

1.4

Compatibility with Medical Devices

Brainlab Medical Instruments

Compatible Brainlab Medical Instruments Kick is compatible with: • Kick Monitor Drape • Sterile Touchpen

Other Brainlab Instruments Additional instrumentation may become available after release of this manual. Contact Brainlab or Brainlab authorized support if you have any questions regarding instrument compatibility with Brainlab software. Only use instruments and spare parts specified by Brainlab. Using unauthorized instruments/spare parts may adversely affect safety and/or effectiveness of the medical device and endanger safety of patient, user and/or environment.

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GENERAL INFORMATION

1.5

Training and Documentation

Brainlab Training To ensure safe and appropriate use, before using the system all users should participate in a training program held by a Brainlab authorized representative.

Supervised Support Before using the system for surgical procedures where computer-aided navigation is considered critical, perform a sufficient number of complete procedures with a Brainlab authorized representative present to provide guidance where necessary.

Responsibility This system solely provides assistance to the surgeon and does not substitute or replace the surgeon’s experience and/or responsibility during its use.

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Training and Documentation

1.5.1

Documentation

Intended Audience This user guide is intended for surgeons and hospital staff.

Relevant System Configurations The information in this guide is relevant for the system configurations below: System Configuration

Art.-No.

Kick Navigation Station

18080

Device

Art.-No.

Monitor Cart

18081

Camera Cart

18082

NOTE: All device article numbers are listed on the system plates on the back side of the Monitor Cart.

Reading User Guides User guides describe complex medical devices and surgical navigation software that must be used with care. It is important that all users of system, instruments and software: • Read the user guides carefully before handling the equipment • Have access to the user guides at all times Disregarding information in the user guides, in particular the disregard of warning and cautions, is considered to be abnormal use.

Available User Guides User Guide

Contents

Software User Guides

• Overview of treatment planning and image-guided navigation • Description of OR system setup • Detailed software instructions

Instrument User Guides

Detailed instructions on instrument handling

Cleaning, Disinfection and Sterilization Guide

Details on cleaning, disinfecting and sterilizing instruments

System User Guides

Comprehensive information on system setup

Technical User Guide

Detailed technical information on the system, including specifications and compliances

NOTE: Available user guides vary depending on the Brainlab product. If you have questions regarding the user guides you received, contact Brainlab authorized support.

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SYSTEM OVERVIEW

2

SYSTEM OVERVIEW

2.1

System Components

Kick System Kick is a navigation platform used for Image Guided Surgery (IGS) incorporating: • A tracking system (optical tracking see page 49) • A computer unit that runs the software (see Technical User Guide) • A display unit to display the navigation, including touch functionality for the user to interact with the software (see page 33) Kick provides a touchscreen and buttons for user interaction. Additionally, the system offers several PC interfaces for connecting video sources, data transfer devices, network integration, or other 3rd-party devices. The camera can be adjusted in height by usage of the telescopic post and further in rotation around vertical and horizontal axis to achieve a good tracking position. The monitor can be declined to receive a good viewing angle for the user. For sterile use, the Kick Monitor Drape shall be used or the Sterile Touchpen.

Optical Tracking Optical tracking is achieved by a camera unit that emits and detects flashes of infrared light. • Reflective elements, affixed to reference arrays on the patient and to instrumentation, reflect the infrared signals back to the camera unit. • Reflected signals from the reflective elements are captured and digitized by each camera lens from a different angle. • Brainlab software applications use the camera input to calculate the relative three-dimensional positions of the instruments and the patient reference arrays.

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System Components

Components - Kick

ི ཱ ཱི ུ

཰

ཱུ

Figure 1

20

No.

Component

See

཰

Telescopic camera post

Page 58

ཱ

Camera

Page 51

ི

Camera Cart

Page 49

ཱི

Monitor Cart

Page 33

ུ

Touchscreen

Page 35

ཱུ

Monitor post

Page 33

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SYSTEM OVERVIEW

2.2

System Setup

System Position Ensure that the system is set up so it is not possible for the patient to touch or come in contact with the equipment. Ensure that the system is set up in a way that the mains power plug is easily accessible. In case of malfunction, you must be able to easily unplug the mains power cable.

Sterile Field The Kick systems are unsterile. If draped, the Monitor Cart may be used within the patient environment (see page 67). Do not allow any system parts to enter the sterile field.

Electromagnetic Compatibility Special precautions regarding electromagnetic compatibility (EMC) must be installed and put into service according to the EMC information provided in this guide and the Technical User Guide. For EMC reasons, do not use system components adjacent to or stacked on other equipment. If it is unavoidable, verify that the Kick system operates normally.

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