kicksynthes.vo.llnwd.net/o16/llnwmb8/int mobile/synthes...1.3 intended use using the system intended...

KICKVersion 1.2

TECHNICAL USER GUIDE

REVISION 1.0

Copyright 2015, Brainlab AG Germany. All rights reserved.

TABLE OF CONTENTS

GENERAL INFORMATION ...................................................................................................5

Contact Data and Legal Information ......................................................................................................5

Legal Information .........................................................................................................................................6

Symbols .......................................................................................................................................................7

Hardware Symbols.......................................................................................................................................8

Intended Use .............................................................................................................................................11

Training and Documentation .................................................................................................................13

Documentation...........................................................................................................................................14

SYSTEM OVERVIEW ..............................................................................................................15

System Components ...............................................................................................................................15

Monitor Cart ..............................................................................................................................................17

3rd-Party Connections ...............................................................................................................................19

LAN Connection.........................................................................................................................................21

Camera Cart ..............................................................................................................................................22

Camera Volume .........................................................................................................................................25

TROUBLESHOOTING ............................................................................................................27

Introduction ...............................................................................................................................................27

Troubleshooting: Monitor Cart..............................................................................................................28

Troubleshooting: Camera Cart..............................................................................................................29

ELECTRICAL SAFETY ..........................................................................................................31

Classification ............................................................................................................................................31

Test Requirements ...................................................................................................................................32

Testing Overview........................................................................................................................................33

Recurrent Tests..........................................................................................................................................35

Performing Tests ......................................................................................................................................37

Leakage Current ........................................................................................................................................38

Insulation Resistance .................................................................................................................................40

Test Report ................................................................................................................................................41

TABLE OF CONTENTS

Kick Ver. 1.2 / Technical User Guide Rev. 1.0 / DePuy Synthes 3

COMPLIANCES AND SPECIFICATIONS .............................................................43

Electrical Standards ................................................................................................................................43

Environmental Requirements................................................................................................................44

System Specifications ............................................................................................................................45

Technical Specifications .............................................................................................................................47

Compliances .............................................................................................................................................48

General Electromagnetic Immunity ............................................................................................................49

Electromagnetic Immunity, Kick System.....................................................................................................50

RF Communications Equipment.................................................................................................................52

Tested Cables ............................................................................................................................................53

Hospital Network........................................................................................................................................54

Power Plugs ..............................................................................................................................................55

Regional Power Plugs................................................................................................................................56

USB Flash Drives .....................................................................................................................................57

MAINTENANCE ............................................................................................................................59

Inspections ................................................................................................................................................59

Inspections.................................................................................................................................................60

Annual Inspection by Brainlab....................................................................................................................61

Air Filter Exchange ..................................................................................................................................62

Damaged Equipment ...............................................................................................................................63

INDEX ....................................................................................................................................................65

TABLE OF CONTENTS

4 Kick Ver. 1.2 / Technical User Guide Rev. 1.0 / DePuy Synthes

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 Ameri-

caTel: +1 (866) 473 7823

Europe, Middle East, Africa Tel: +32 2 352 16 66

Asia, Australia Tel: +65 6827 6154

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.

Feedback

Despite careful review, this guide may contain errors.

Please contact us at [email protected] if you have suggestions as to how we can

improve this guide.

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.

Non-Brainlab Trademarks

Intel® is a registered trademark of Intel Corporation in the US and other countries.

CE Label

• The CE label shows that the Brainlab product complies with the essential re-

quirements of Council Directive 93/42/EEC (the "MDD").

• According to the principles set out in the MDD, Council Device Directive 93/42/

EEC, 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 regu-

lations. For information regarding the WEEE (Waste Electrical and Electronic Equip-

ment) directive, visit:

http://www.brainlab.com/weee

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

authorized support in case of any related questions.

Contact Data and Legal Information


1.2 Symbols

Symbols Used in This Guide

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.

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 humidi-

ty 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

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 icon

Consult the operating instructions

GENERAL INFORMATION


Symbol Explanation

Consult accompanying documentation

Symbols


1.3 Intended Use

Using the System

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.

Technical Specifications

The technical specifications of Kick hardware components are subject to change due to technical

developments.

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.

Changes to the System

Only use the system components as delivered by Brainlab. Do not modify the system in

any way. Altering the system or using it outside of its intended use may result in severe

harm to the patient, user or third-party.

MR Environment

The Kick system has not been tested in an MR environment.

Plausibility Review

Before patient treatment, review the plausibility of all information input to and output from

the system.

ME Systems

Additional equipment connected to medical electrical equipment must comply with the

respective IEC or ISO standards (e.g., IEC 60950 for data processing equipment and IEC

60601-1 for medical equipment). Furthermore, all configurations shall comply with the

requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd

edition of IEC 60601-1, respectively). Anyone connecting additional equipment to the Kick

System configures a medical system and is therefore responsible that the system complies

with the requirements for medical electrical systems. Please note that local laws take

priority over the above-mentioned requirements. In doubt, consult your local

representative or the technical service department.

GENERAL INFORMATION


NOTE: Unless otherwise specified, the use of multiple socket outlet(s) is not permitted.

Intended Use


1.4 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.

GENERAL INFORMATION


1.4.1 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. Device Art.-No.

Kick Navigation Station 18080Monitor 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

The user guides describe complex medical devices and surgical navigation software that must be

used with care.

It is important that all users of the 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.

How to Use This Guide

The information provided in this guide will help you to determine whether your navigation system

is functioning properly.

Use this guide, in combination with assistance from Brainlab authorized support, to identify and

troubleshoot possible problems.

Do not attempt to service your system. Contact your Brainlab authorized support

representative for questions regarding repair and service.

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

Detailed instructions on cleaning, disinfecting and sterilizing in-

struments

System User Guides Comprehensive information on system setup

Technical User GuideDetailed technical information on the system, including specifica-

tions and compliances

NOTE: Not all above-mentioned user guides are available or relevant for all Brainlab products.

Training and Documentation


2 SYSTEM OVERVIEW

2.1 System Components

General Information

Kick is a touchscreen-operated planning and navigation system designed for pre- and

intraoperative use. All system components are suitable for continuous use during surgical

procedures.

The Kick system is a navigation platform used for image guided surgery, consisting of:

• 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

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 marker spheres and discs are captured and digitized by

each camera lens from a different angle.

• The software uses the camera input to calculate the relative three-dimensional positions of the

instruments and the patient reference arrays.

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 System User Guide.

SYSTEM OVERVIEW


Components

Figure 1

No. Component

Telescopic camera post

Camera

Camera Cart

Monitor Cart

Touchscreen

Monitor post

System Components


2.2 Monitor Cart

Monitor Cart Components

Figure 2

No. Component

Wheels

• Monitor Cart handle

• Monitor release trigger (back side of handle, not visible)

Monitor hinge

Touchscreen

Monitor cable

Cable hooks

On/off button

Monitor Cart base, containing:

• Medical computer unit

• Connection panel

SYSTEM OVERVIEW


Monitor Components

Figure 3

No. Component

Monitor release trigger (back side of monitor handle)

Home button

NOTE: The function of this button may vary depending on the software application. See

relevant Software User Guide for more information.

USB ports (top of monitor, covered by flap)

Monitor Cart


2.2.1 3rd-Party Connections

General Information

The 3rd-party equipment connections are located on the connection panel.

When connecting 3rd-party devices, adhere to the applicable regulations in IEC 60601-1-1,

specifically clause 16 of the 3rd edition of IEC 60601-1.

Connection Panel

Figure 4

No. Component

Mains power

Potential equalization

S-Video In

Video In

Hospital Network

Intraoperative data

USB

Tracking unit (Camera Cart)

Kolibri upgrade camera connection (covered in image)

Microscope and Video Out

NOTE: The unused tracking unit port is covered. If your tracking unit port requirements change,

contact Brainlab support.

WLAN Transmitter

The WLAN transmitter hardware deactivated in this version, but can be reactivated by service:

• The WLAN transmitter uses a frequency band for sending and receiving between 2.400 and

2.485 GHz with 19.8 Bm effective isotropic radiated power (EIRP).

SYSTEM OVERVIEW


• The device is configured to use channel 1 to 11 (each with a channel space of 22 MHz). This

setting matches the regulatory requirements for USA, Canada, Japan, Europe, Australia, Hong

Kong and New Zealand. Contact Brainlab support or an authorized partner in case of

questions.

• The characteristic of modulation is DSSS for 802.11b,g or OFDM for 802.11n.

Monitor Cart


2.2.2 LAN Connection

LAN Ports

The LAN ports support:

• 10 Mbps, 100 Mbps, and 1000 Mbps connections

• Automatic MDI/MDI-X configurations

Figure 5

LED Status Indication

ACT/LINK LED

Off No link

Solid orange Linked

Flashing orange Data activity

Speed LED

Off 10 Mbps connection

Orange 100 Mbps connection

Green 1 Gbps connection

Network Connection

Kick interfaces provide no means of separation according to IEC 60601-1:2005. It is

recommended to use an adequate separation device for the network (LAN) interface with a

rating of minimum 1 MOOP and a dielectric strength of minimum 1.5 kV.

Connecting Kick to a hospital network may create an ME system according to IEC

60601-1:2005. Ensure that hospital network components are compliant to the relevant IEC

standard.

SYSTEM OVERVIEW


2.3 Camera Cart

Components

Figure 6

No. Component

Camera Cart base

Cable hooks

• Telescopic post

• Spiral camera cable (not visible)

Camera adjustment handle

Camera

Camera hinge

• Camera handle

• Camera release trigger (back side of handle, not visible)

Clamping lever

Camera Cart


Camera Components

Figure 7

No. Component

Camera release trigger

Camera handle

Positioning laser

Lens

Illuminator filter

Camera adjustment handle

Laser trigger

Power Specifications

Specification Value

Voltage 18-32 Vdc

Power consumption 13.5 W

SYSTEM OVERVIEW


Positioning Laser Specifications

The camera contains a Class II positioning laser .

Specification Value

Wavelength 635 nm

Maximum output 1 mW

Conforms to standards

• ANSI Z136.1 (2007)

• IEC 60825-1 (2007)

• FDA/CDRH 21 CFR 1040.10 and 1040.11 (except for deviations

pursuant to Laser Notice No. 50, dated June 24, 2007)

Camera Cart

24 Kick Ver. 1.2 | Technical User Guide Rev. 1.0 / DePuy Synthes

2.3.1 Camera Volume

Illustration

The camera field of view is a pyramid-shaped volume with the following dimensions:

Figure 8

No. View

Behind camera

Side

Top

How to Test the Camera Volume

Steps

1. Place an instrument with attached reflective marker spheres in the camera field of view.

2. Adjust the camera horizontally.

3. Measure the working distance.

4.

Measure the volume diameter at several distances.

NOTE: If the camera field of view is significantly decreased, the camera may need to be

repaired or exchanged.

NOTE: You can also check the camera field of view in the software as described in the Software

User Guides.

Tracking Unit Accuracy

To ensure the specified accuracy of the camera, adhere to the storage and operating

conditions (see page 44).

SYSTEM OVERVIEW


Camera Cart


3 TROUBLESHOOTING

3.1 Introduction

Chapter Information

The purpose of this chapter is to provide you with specific information in order to recognize

possible problems and communicate them to your Brainlab support representative.

Repair and Service

Do not attempt to service your system. Contact Brainlab authorized support for questions

regarding repair and service.

TROUBLESHOOTING


3.2 Troubleshooting: Monitor Cart

Possible Occurrences

Power to the Monitor Cart

Occurance Possible Cause

No power to Monitor CartCheck that the mains power cabling is correctly

connected to power supply.

Touchscreen Display

There are two main functional monitor parts that affect the display:

• The display itself

• The backlight


Some pixels (from which the displayed images

are constructed) may fail over time.The display may need to be replaced.

Touchscreen Functionality


No touch functionality.

• The touch controller not functioning, or

• The driver that controls the mouse cursor not

functioning.

Cursor position on the screen does not corre-

spond to the part of the screen touched.

Calibration of the cursor has been lost. Contact

Brainlab support.

Troubleshooting: Monitor Cart


3.3 Troubleshooting: Camera Cart

Possible Occurrences

Camera Occurrences

There are several possible occurrences that can be attributed to communication failures related to

the IR camera.

Occurance Symptoms Possible Causes

Decrease in cam-

era volume

• Restricted field of view

for navigation.

• LEDs in camera lens are

not on.

• Overheating

• Ageing of camera

• IR light from another device causing interfer-

ence (e.g., pulse oximeter).

• Surfaces in the OR are unintentionally re-

flecting IR light (e.g., reflective strips on

clothing).

No powerCamera does not beep

during boot-up.

• Problem with cabling

• Problem with electronics

No communicationCamera does not beep

during application start up.

• Communication error between Monitor and

Camera Carts: Check cabling

• Incorrect software configuration

Not tracking mark-

er spheres proper-

ly

Software displays uniden-

tifiable gray marker

spheres in the camera

field of view.

• IR light from another device causing interfer-

ence (e.g., pulse oximeter).

• Surfaces in the OR are unintentionally re-

flecting IR light (e.g., reflective strips on

clothing).

NOTE: If you are having problems with your camera, contact Brainlab authorized support.

TROUBLESHOOTING


Troubleshooting: Camera Cart


4 ELECTRICAL SAFETY

4.1 Classification

Monitor Cart and Camera Cart

The Monitor Cart and the Camera Cart are classified as Class I Equipment according to IEC

60601-1 and must be tested accordingly.

Classification Definition

Class I

Refers to equipment classification regarding protection against electric shock.

Protective means are provided for metallic accessible parts or metallic internal

parts, such as connection to PE (protective earth).

Safety Requirements

To avoid the risk of electrical shock, the Monitor Cart must only be connected to a mains

power supply with protective earth.

ELECTRICAL SAFETY


4.2 Test Requirements

Interval

The recurrent test should be performed once annually or if the equipment is repaired or modified.

The test is mandatory for medical electrical equipment and when creating a medical electrical

system according to IEC 60601-1-1 or clause 16 of the 3rd edition of IEC 60601-1, respectively.

Repeat this test any time the medical electrical equipment or medical electrical system setup is

changed, e.g., after repair of one or all combined equipment or after the exchange of equipment

components like cables.

For sustained safety of the equipment, a yearly electrical safety test according to IEC 62353

is required. For an ME SYSTEM or permanently installed equipment, an electrical safety

test according to IEC 60601-1 may be required.

NOTE: Local regulations, national deviations and requirements that vary from these standards

take precedent.

Scope

The test must include all the items as specified starting on page 33.

Each individual equipment of the ME SYSTEM that has its own connection to supply mains, or

which can be connected/disconnected from mains supply without the use of a tool, must be tested

individually. Additionally, the ME SYSTEM must be tested as a whole to avoid that an aging

component causes unacceptable values.

If items of ME EQUIPMENT that are combined into an ME SYSTEM by functional connections

cannot be tested separately for technical reasons, test the complete ME SYSTEM.

In addition, Brainlab support or authorized partners shall regularly clean air intake filters and

exchange the battery when necessary.

Inspections by Non-Brainlab Personnel

Only qualified, trained and skilled personnel are allowed to perform electrical safety tests.

Qualification shall include training on the subject, test equipment, knowledge, experience

and acquaintance with the relevant technologies, standards and local regulations.

Personnel assessing the safety must be able to recognize possible consequences and

risks arising from non-conforming equipment.

Brainlab must be informed immediately in writing if equipment is deemed unsafe.

Inspections by Brainlab Authorized Support

• If a suitably qualified person is not available at the customer site, Brainlab support will perform

this inspection for a set fee.

• Brainlab performs an inspection at the end of the warranty at no charge.

• If you require a Brainlab support specialist, contact Brainlab support.

Test Requirements


4.2.1 Testing Overview

Testing Precautions

ME SYSTEM test steps must be performed as described below.

• The described test only covers the Brainlab Kick equipment and not connected equipment.

• In addition, follow the directions given by the manufacturer of the connected device.

• During measurement, all devices must be in operation mode.

• Perform tests in normal condition as well as in single fault condition.

Visually inspect the ME SYSTEM to determine whether the configuration is still the same as

at the time of the last inspection, or whether units of the ME SYSTEM have been

exchanged, added or removed. Such changes must be documented, as well as any

changes to the configuration of ME SYSTEM. Any changes void the validity of previous

reference values.

Test Guidelines

When performing recurrent tests:

• Perform required test steps in the order defined below.

• All tests must be passed before the device can be considered safe.

• The calibration of the measuring device must be valid at the time of measurement.

• Measurement results measured after changes of the ME SYSTEM shall be documented as

reference values.

If a test does not pass, device must be repaired by Brainlab support.

Required Test Steps for ME EQUIPMENT

Steps

1. Visual inspection

2. Protective earth resistance

3. Equipment leakage current

4. Insulation resistance

5. Functional test

6. Report results

7. Evaluate results

8. Check and prepare for normal use

Required Test Steps for ME SYSTEMS

Steps

1.

Test each piece of equipment of the ME SYSTEM individually, according to steps 1-4 for

ME EQUIPMENT.

Report and evaluate these results.

2. Touch current

3. Functional test

4. Report results

ELECTRICAL SAFETY


Steps

5. Evaluate results

6. Check and prepare for normal use

Test Report Form

• Use the test report form (from page 41) to enter the inspection results.

• Keep form as a record of the inspection.

Test Requirements


4.2.2 Recurrent Tests

Test Steps to Be Performed

IEC 62353 is the basis for measurement requirements, conditions and setup.

Step Instructions and Conditions

Visual inspection

Prepare device for normal use. Use original power supply cord provided

by Brainlab.

Check all relevant cables for dents, damaged insulation and blank lines.

Move and bend the cables around your hand to slightly stretch the insula-

tion. Any visible damage is not acceptable.

Check Kick for visible damage, broken cables and blank lines. With the

exception of air vents, you should not be able to see the interior of the de-

vice. Damaged cables, blank lines or visibility of the interior are not ac-

ceptable.

Check indicator LEDs for detected errors.

If any damages are detected, place the device out of operation, mark as

such and contact Brainlab support.

Protective earth re-

sistance ( Monitor

Cart only)

Definition:

Resistance between any accessible conductive part that must, for safety

purposes, be connected to the protective earth terminal and one of the

following:

• Protective connector of the mains plug

• Protective connector of the appliance inlet, or

• Protective conductor permanently connected to the mains supply

Resistance between protective connectors at each end of a detachable

power supply cord.

Prepare device for normal use.

Measure the protective earth resistance for all measurement points indi-

cated starting on page 37.

Equipment leakage

current

Definition:

Current flowing from mains parts to earth via the protective earth conduc-

tor and accessible conductive parts of the enclosure and applied parts.


If you are using an electrical safety test device, connect the Monitor Cart

to the device when testing a Kick system.

Measure the earth leakage current for all measurement points indicated

starting on page 38.

Touch current (Re-

quired for ME SYS-

TEM)

Definition:

Leakage current flowing from the enclosure or from parts thereof, exclud-

ing patient connections, accessible to any operator or patient in normal

use, through an external path other than the protective earth conductor, to

earth or to another part of the enclosure.



to the device when testing a Kick system.

Connect the required functional connections to create the medical electri-

cal system and switch devices on.

Measure the touch current for all measurement points indicated starting

on page 38.

ELECTRICAL SAFETY

Kick Ver. 1.2 | Technical User Guide Rev. 1.0 / DePuy Synthes 35

Step Instructions and Conditions

Patient leakage cur-

rent

Definition:

• Leakage current flowing from the patient connections via the patient to

earth, or

• Originating from the unintended appearance of a voltage from an exter-

nal source on the patient and flowing from the patient via the patient

connections of an F-TYPE applied part to earth.


Select a non-conductive surface to position the applied part.

Measure the patient leakage current as indicated on page 33.

Insulation resistance

Definition:

For Class I electrical equipment resistance of insulating material is meas-

ured at the mains supply between the live and neutral pins connected to-

gether and the protective earth pin.



to the device when testing.

Measure the insulation resistance between the connected mains supply

line/neutral (L/N) and the protective earth (PE).

Functional test


Power on the device.

Check that indicator LEDs do not show errors. Check for system alarms.

NOTE: For detailed information on indicator LEDs and system alarms,

see the System User Guide.

Before starting surgery, start the system, ensuring that it boots up correct-

ly and patient data is correctly loaded in the navigation application.

Report results Generate a test report.

Evaluate results Determine whether the device is safe and effective.

Check and prepare

for normal use

After testing, check that the device is restored to the conditions necessary

for normal use before being returned into service.

Remove all devices that have been connected, e.g., measurement device

with probes and lines.

Acceptable Values

Values are limited according to the standards.

Test Step Standard

Protective earth resistance

IEC 62353Equipment leakage current

Insulation resistance

Patient leakage current

Touch current IEC 60601-1

Measured Values

Required measurement points are listed starting on page 37.

A sample test report form is available starting from page 41.

Test Requirements


4.3 Performing Tests

Protective Earth Resistance

General Information

Connect the measurement tip of your measuring device with the conductive parts shown in the

table below and measure the resistance.

If a test does not pass, device must be repaired by Brainlab support. After repair, repeat the

entire electrical safety test from the beginning.

Protective Earth

Measurement Point

Potential equalization port

Microscope fixation screw

ELECTRICAL SAFETY


4.3.1 Leakage Current

General Information

Connect the measurement tip of your measuring device with the conductive parts shown in the

table and measure the leakage current.

Equipment Leakage Current

Measurement Point

Monitor fixation screw

Monitor cart base

Camera plug at connection panel

Screw on camera hinge

Camera cart base

Performing Tests


Measurement Point

Screw on clamping lever (telescopic post)

ELECTRICAL SAFETY


4.3.2 Insulation Resistance

General Information

Connect the device to your measurement device and measure the insulation resistance.

Performing Tests


4.4 Test Report

Test Report Form

Below is an example of test documentation with minimum specifications.

Testing organization:

Tester name:

Test before putting into service (reference val-

ue):

Recurrent test:

Test after repair:

Responsible organization:

Equipment/device tested: ID-Number:

Type: Serial number:

Manufacturer: Class of protection:Class I Class II Battery

Applied part type:

N/A

B

BF

CF

Mains connection:

Permanently installed equipment

Non-detachable power supply

cord

Detachable power supply cord

Equipment type:

ME EQUIPMENT

ME SYSTEM

Accessories:

Test

Measurement equipment (model, ID, calibration date):

Test passed?

Yes/No

Visual inspection

Measurements:Measured value Test passed?

Yes/NoNC SFC

Protective earth resistance - mΩ

Equipment leakage current - al-

ternative methodμA

Equipment leakage current - di-

rect methodμA

Equipment leakage current - dif-

ferential methodμA

Touch current (ME SYSTEM) μA

Patient leakage current (applied

parts) - alternative methodμA

Patient leakage current (mains

on applied parts) - direct meth-

od

μA

Insulation resistance - MΩ

Other

Functional test (parameters tested):

Device has been checked and is prepared for normal use

ELECTRICAL SAFETY


Deficiency/Notes:

Overall assessment:

No safety or functional deficiencies were detected.

No direct risk, deficiencies detected may be corrected on short term.

Equipment shall be taken out of operation until deficiencies are corrected.

Equipment does not comply: Modification/exchange of components/taking out of service is

recommended.

Next recurrent test necessary in __

months:

6 12 24 36

Name: _________________________ Date / Signature: ______________________________

Test Report


5 COMPLIANCES AND

SPECIFICATIONS

5.1 Electrical Standards

Certificates and Approvals

Certificate/Approval

Certificates

IEC 60601-1

ANSI/AAMI ES60601-1

EN60601-1

IEC 60529 IP20

Power Specifications - North America

In North America: if the unit is connected to 240 V, only connect it to a center-tapped outlet

labeled 240 V power supply.

COMPLIANCES AND SPECIFICATIONS


5.2 Environmental Requirements

Transport/Storage and Operating Conditions

Local Restrictions

• Store and operate systems in locations that are protected against moisture, wind, sunlight,

dust, salinity and sulfur.

• Do not store systems in the close vicinity of chemical products or gas.

• Do not expose systems to direct UV light.

Altitude Considerations

• Unless stated otherwise, the system is rated for use at an altitude < 3000 meters.

• Transport or store the system at an altitude < 6000 meters.

Adaption Time

Adaption time for use after extreme storage conditions is a minimum of one hour.

Environmental Conditions - Kick

The following environmental requirements apply for the Kick system:

Specification Operating Conditions

Temperature 10°C (50°F) to 35°C (95°F)

Humidity 30% to 75% non-condensing

Pressure 700 hPa to 1060 hPa

Specification Transport/Storage Conditions

Temperature-10°C (14°F) to 45°C (113°F) (for a period of time not exceeding 15

weeks)

Humidity 10% to 90% non-condensing

Pressure 500 hPa to 1060 hPa

NOTE: Transport/storage values are valid for the system when contained in the transport cases.

Environmental Requirements


5.3 System Specifications

Physical Characteristics

Monitor Only

Specification Value

Height 328 mm

Width 540 mm

Depth 75 mm

Weight 6.7 kg

Monitor Angle Flexibility See System User Guide.

NOTE: These values are based on the monitor without the protection cover.

Camera Only

Specification Value

Height 76 mm

Width 630 mm

Depth 115 mm

Weight 2.6 kg

NOTE: These values are based on the camera without the protection cover.

Complete Monitor Cart

Figure 9



Specification Value

Height 1550 mm

Footprint 500 x 500 mm

Weight 25.5 kg

Complete Camera Cart

Figure 10

Specification Value

Max. Height 2350 mm

Min. Height 1450 mm

Footprint 500 x 500 mm

Weight 19 kg

System Specifications


5.3.1 Technical Specifications

Monitor Cart and Medical Computer Unit

Specification Value

Electrical Specifications

AC input 100 VAC - 240 VAC

Frequency 50/60 Hz

Power consumption3 A @ 100 VAC

1.5 A @ 240 VAC

CMOS Battery 3V CR2032 Lithium Battery 210 mAh

Processor Intel Core i5-520E 2.40 GHz

RAM 4 GB

Supported I/O

• 6 USB 2.0

• Potential equalization

• Camera

• S-Video In

• 2 LAN 1 GBit/s

• CVBS

• DVI-I

Mass Storage Internal Hard Disk 2.5” 160 GB

Audio• 2 W

• Speaker volume: 60-65 dB(A)

Display 21.46”, FHD resolution

Touchscreen Resistive touchscreen

Camera Cart

Specification Value

Input Voltage 18-32 Vdc

Power Consumption 13.5 W

Tracking Accuracy 0.3 mm RMS (Root Mean Square)



5.4 Compliances

Electromagnetic Emissions

Electromagnetic Environment

Kick systems are intended for use in the electromagnetic environment specified in the table

below.

The user is responsible ensuring that the systems are used in such an environment.

Declaration

Guidance and manufacturer’s declaration regarding electromagnetic emissions:

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions CISPR

11Group 1

The Kick system uses RF energy only for its internal

function. Therefore, its RF emissions are very low

and are not likely to cause any interference in nearby

electronic equipment.

RF emissions CISPR

11Class A

The Kick system is suitable for use in all establish-

ments other than domestic, and may be used in do-

mestic establishments and those directly connected

to the public low-voltage power supply network that

supplies buildings used for domestic purposes, pro-

vided the warnings in this user guide are heeded.

Harmonic emissions

IEC 61000-3-2Class A

Voltage fluctuations/

flicker emissions IEC

61000-3-3

Complies

The system should not be used adjacent to, or in direct contact with other equipment. If

this cannot be avoided, normal operation must be verified in the configuration in which it

will be used.

Compliances


5.4.1 General Electromagnetic Immunity

Electromagnetic Environment

Kick systems are intended for use in the electromagnetic environment specified in the following

sections.

The user is responsible ensuring that the systems are used in such an environment.

Electromagnetic Immunity Declaration

The tables in the following sections provide guidance according to the manufacturer’s

electromagnetic immunity declaration.



5.4.2 Electromagnetic Immunity, Kick System

IEC 61000-4-2, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-8, IEC 61000-4-11

Immunity Test IEC 60601 Test Level and

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic dis-

charge (ESD) IEC

61000-4-2

± 6 kV contact

± 8 kV air

Floors should be wood, concrete or ceramic

tile. If floors are covered with synthetic mate-

rial, the relative humidity should be at least

30%.

Electrical fast tran-

sient/burst IEC

61000-4-4

± 2 kV for power supply

lines

± 1 kV for input/output lines

Mains power quality should be that of a typi-

cal commercial or hospital environment.

Surge IEC

61000-4-5

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth


cal commercial or hospital environment.

Voltage dips, short

interruptions and

voltage variations

on power supply in-

put lines IEC

61000-4-11

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

for 0.5 cycle

40% UT (60% dip in UT) for

5 cycles

70% UT (30% dip in UT) for

25 cycles

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

for 5 s


cal commercial or hospital environment. If the

Kick system user requires continued opera-

tion during power mains interruptions, it is

recommended that the Kick system be pow-

ered from an uninterruptible power supply or

a battery.

Power frequency

(50/60 Hz) magnet-

ic field IEC

61000-4-8

3 A/m

Power frequency magnetic fields should be

at levels characteristic of a typical location in

a typical commercial or hospital environment.

NOTE: UTis the AC mains voltage prior to application of the test level.

IEC 61000-4-6, IEC 61000-4-3

Immunity

Test

IEC 60601

Test Level

Compliance

Level


Conducted

RF IEC

61000-4-6-

3 Vrms 150

kHz to 80

MHz

3 V

Portable and mobile RF communications equip-

ment should be used no closer to any part of the

Kick system, including cables, than the recom-

mended separation distance calculated from the

equation applicable to the frequency of the

transmitter.

Recommended separation distance:

d 1 2 P,=

d 1 2 P,= 80 MHz to 800 MHz

d 2 3 P,= 800 MHz to 2.5 GHz

Compliances


Immunity

Test

IEC 60601

Test Level

Compliance

Level


Radiated RF

IEC

61000-4-3

3 V/m 80

MHz to 2.5

GHz

3 V/m

Where P is the maximum output power rating of

the transmitter in watts (W) according to the

transmitter manufacturer and d is the recom-

mended separation distance in meters (m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site surveya

should be less than the compliance levelb in

each frequency range.

Interference may occur in the vicinity of equip-

ment marked with this symbol:

NOTE: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation 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) tele-

phones and land mobile radios, amateur radio, AM and FM radio 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 Kick system is used exceeds the applicable RF compli-

ance level above, the Kick system should be observed to verify normal operation. If abnormal

performance is observed, additional measures may be necessary, such as re-orienting or relo-

cating the Kick system.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.



5.4.3 RF Communications Equipment

Electromagetic Environment

Portable and mobile RF communications equipment can affect the systems.

The Kick system is intended for use in an electromagnetic environment in which radiated RF

disturbances are controlled.

The Kick system user can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment (transmitters) and the Kick

system as recommended below, according to the maximum output power of the communications

equipment.

Separation Distances

Recommended separation distances between portable and mobile RF communications equipment

and the Kick system:

Rated Maximum Out-

put Power of Trans-

mitter (W)

Separation Distance According to Frequency of Transmitter (m)

150 kHz to 80 MHz

d 1 2 P,=

80 MHz to 800 MHz

d 1 2 P,=

800 MHz to 2.5 GHz

d 2 3 P,=

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.2 1.2 2.3

10 3.7 3.7 7.4

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separa-

tion distance d in meters (m) can be determined 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: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects and people.

Compliances


5.4.4 Tested Cables

Use of Specified Cables

The use of accessories and cables other than those specified (with the exception of cables

sold by Brainlab as replacement parts), may result in increased emissions or decreased

immunity of the equipment.

Cable Specifications

Kick system cables that have been tested for emission and immunity conformity:

Cable Specification

Optical tracking unit cable Provided by Brainlab; 10 m long

Power cable Provided by Brainlab; 5 m long

Potential equalization cable Provided by Brainlab; 5 m long

S-Video 2 BNC coax cables, shielded, terminated, 75 Ohm; 30 m long

CVBS BNC coax cable, shielded, terminated, 75 Ohm; 30 m long

Hospital Network Provided by Brainlab; 5 m long

Intraoperative Data Provided by Brainlab; 5 m long

Microscope Provided by Brainlab; 10 m long



5.4.5 Hospital Network

General Information

Users must identify, analyze, evaluate and control the risks that may occur when connecting the

Kick system to a network or data coupling where other equipment is connected.

Wireless networks must comply with the definitions of the standard 802.11n.

Making changes to the network/data coupling could introduce new risks that require additional

analysis. These changes may include, but are not limited to:

• Changes in configuration

• Connection or disconnection of additional equipment

• Update or upgrade of connected equipment

Network Information Flow

For patient data transfer, the Kick system receives data from the hospital network server (e.g.,

PACS server).

For remote access, streaming or session sharing, the Kick system sends data to a streaming

client inside the hospital network.

Hospital Network Requirements

Requirement Values

Bandwidth

• Minimum: 2 Mbit/s (e.g., for data transfer)

• Recommended: 10-50 Mbit/s (e.g., for streaming and remote access)

• Optimum: 100 Mbit/s - 1Gbit/s (e.g., for session sharing)

Latency

• Maximum: ≤ 100 ms

• Recommended: ≤ 25 ms

• Optimum: ≤ 2 ms

Safety

• Only connect equipment to a secured network

• Network protected against unwanted access (e.g., user authentication,

firewall, etc.)

• Network protected against malicious software

• Internet Protocol Suite (TCP/IP)

Network Precautions

Streaming the display content of the Kick system or using session sharing may create high

traffic load on the hospital network.

When integrating the Kick system to a wireless hospital network, select an adequate

encryption (WPA2 or better) to protect patient data from unauthorized access.

Potential Hazards of Network Failure

The following hazardous situations could result if the hospital network or data coupling does not

meet the requirements listed in this section:

• Patient treated incorrectly due to:

- Network failure during patient data transfer

- Malware (e.g., viruses) causing PC to miscalculate data

• Unwanted exposure of the patient to anesthetics or radiation due to network failure during

patient data transfer

Compliances


5.5 Power Plugs

General Information

The Kick system comes equipped with a specific power plug suitable for the region of use.

Use of Specified Power Cords

Reliable grounding can only be achieved when the system is connected to an equivalent

receptacle marked “Hospital Only” (“Hospital Grade” in North America). Only insert the

main plug into a socket outlet that is protectively earthed. Do not negate the protective

action by the use of an extension cable.



5.5.1 Regional Power Plugs

Power Plugs (Examples)

Power Plug Region

EU

Switzerland

UK

US

Australia

South Africa

Power Plugs


5.6 USB Flash Drives

General Information

You can use a USB flash drive to transfer patient data between Brainlab planning and navigation

stations.

Handling USB Flash Drives

When using a USB flash drive, keep the following points in mind:

• Do not directly touch the USB connector (metal part of the USB flash drive).

• After use, replace the cover on the USB flash drive.

USB flash drives are highly sensitive to electrostatic discharge. Handle them with care to

prevent damage to the device.



USB Flash Drives


6 MAINTENANCE

6.1 Inspections

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.

Ensuring Safety and Functionality

Do not carry out inspections or maintenance while Kick is being used for patient treatment.

The system should be maintained and inspected on a regular basis to ensure functionality

and safety.

Interval

A detailed inspection should be performed by Brainlab support once a year (see page 61).

Authorized Persons

Only Brainlab and/or authorized partners are allowed to service the system and equipment.

Risk of electrical shock: There are no user-serviceable parts. All servicing is to be carried

out by trained technicians or referred to Brainlab.

Before Using the System

If the system has not been used for an extended period of time, verify that everything operates

normally before beginning patient treatment.

MAINTENANCE


6.1.1 Inspections

Weekly

Component Inspection

Cabling and connectors Visual control (look for damage, twists, cracks)

Cleaning Refer to the System User Guide

Monthly


General components

• Inspect for physical damage

• Marking and type plates readable

• Function of connection to 3rd-party equipment (e.g., microscope)

Wheels and brakes

( Monitor Cart and Cam-

era Cart)

Functionality

Camera

• Functionality

• Visual inspection (wear and tear)

• Both lenses are clean and not scratched or otherwise damaged

Monitor Cart

• Functionality

• Stability of the monitor fixation and scratches on the touchscreen

• Standby button

• Power LED

• USB connection

• Network connection

Monitor Cart and Cam-

era CartCheck that there are no loose or missing screws.

Inspections


6.1.2 Annual Inspection by Brainlab

Arrangement

• If you have a service contract, Brainlab automatically performs the annual inspection.

• If you do not have a service contract, contact Brainlab support to arrange the inspection.

Scope

This inspection covers all components and functions as well as the items specified on the safety

inspection form.

Annual Inspection Points


Camera Cart

• Functional test of camera

• Functional test of camera handle

• Functional test of complete cart

• Check of mechanical support system (posts, wheels and locks)

Monitor Cart

• Functional test of device

• Check of mechanical support system (posts, wheels and locks)

• Air filter exchange

System • Electrical safety test (see page 31)

MAINTENANCE


6.2 Air Filter Exchange

Authorization

Only Brainlab, authorized partners and trained hospital technicians are allowed to exchange the

air filter.

Exchange Interval

The Monitor Cart air filter must be exchanged annually. If you have a service contract, Brainlab

automatically performs air filter exchange.

If you do not have a service contract, contact Brainlab support to request a replacement air filter.

Replacement Filters

Only use replacement air filters that are provided by Brainlab.

Replacement filters come attached to the air vent cover, i.e., the entire air vent cover is replaced.

How to Exchange Air Filter

Figure 11

Steps

1. Push down on the vent clips to remove the air vent cover.

2. Replace with new air vent cover, ensuring the vent clips click into place.

Air Filter Exchange


6.3 Damaged Equipment

Discontinue Use

If you discover a defect:

Steps

1. Switch the system off.

2. Disconnect the system from mains power by unplugging power cable.

3. Contact Brainlab authorized support.

4. Place a notice such as “DO NOT USE” on the equipment to prevent inadvertent use.

Do not continue to use equipment that has been found to be defective during an

inspection. Using damaged equipment may cause patient injury.

Required Information

When you contact Brainlab support regarding a defect, you are asked for:

• System serial number on the Monitor Cart type plate

• Component serial number inscribed on the component (Monitor, Camera Cart components)

• A description of the problem

Repair/Replacement

Brainlab support:

• Provides you with a cost estimate for repair or replacement

• Informs you when your system is expected to be operational again (usually within 48 hours)

Return Instructions

Refer to the System User Guide.

MAINTENANCE


Damaged Equipment


INDEXNumerics

3rd-party connections.................................................................19

A

annual inspection....................................................................... 61

C

cables......................................................................................... 53

camera field of view....................................................................25

camera volume...........................................................................25

CE label........................................................................................6

certificates.................................................................................. 43

connection panel........................................................................ 19

contact information....................................................................... 5

D

damaged equipment...................................................................63

dielectric strength....................................................................... 40

dimensions................................................................................. 45

documentation............................................................................14

E

electrical safety

inspection interval...................................................................32

test guidelines.........................................................................33

electromagnetic emissions......................................................... 48

electromagnetic environment..................................................... 48

electromagnetic immunity...........................................................50

equipment damage.....................................................................63

F

FCC Statement.............................................................................6

feedback.......................................................................................5

functional earth resistance......................................................... 37

G

guides.........................................................................................14

H

hospital network

hazards...................................................................................54

requirements...........................................................................54

I

inspections

annual.....................................................................................61

authorized persons................................................................. 59

interval.................................................................................... 59

monthly................................................................................... 60

weekly.....................................................................................60

L

laser

camera positioning................................................................. 24

M

manuals......................................................................................14

manufacturer................................................................................ 5

medical electrical system............................................................11

monthy inspections.....................................................................60

O

optical tracking system............................................................... 15

P

positioning laser......................................................................... 24

power plugs................................................................................ 55

regional...................................................................................56

protective earth resistance......................................................... 37

R

recurrent test

guidelines............................................................................... 33

requirements...........................................................................32

revision numbers........................................................................ 11

RF communications equipment..................................................52

S

size measurements.................................................................... 45

support......................................................................................... 5

symbols

hardware.................................................................................11

user guide.................................................................................7

system components................................................................... 16

system revision numbers............................................................11

system size.................................................................................45

T

technical specifications

camera cart.............................................................................47

monitor cart.............................................................................47

training........................................................................................13

troubleshooting

camera cart.............................................................................29

monitor cart.............................................................................28

U

USB flash drives.........................................................................57

user guides.................................................................................14

W

WEEE...........................................................................................6

weekly inspection....................................................................... 60

INDEX


DePuy Synthes Sales, Inc.

325 Paramount Drive

Raynham, MA 02767

www.depuysynthes.com

Art-No. 60915-25EN

*60915-25EN*

DS

US

/SP

N/0

615/0

920

DS

EM

/SP

N/0

615

/0315

06/1

5

kicksynthes.vo.llnwd.net/o16/llnwmb8/int mobile/synthes...1.3 intended use using the system intended...

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