Instructions for Use Stryker NAV3i™ Platform

Stryker NAV3i™ Platform
REF 7700-800-000
Instructions for Use
c1275
2013-09-26
TD7700800700 Rev. D
www.stryker.com
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Table of Contents
Indications for Use
6
Contraindication6
Essential Performance of the NAV3i Platform
6
Overview NAV3i Platform
6
IO-Tablet7
Main Power button
7
Virtual Keyboard button
7
Touch Lock button
7
Right Mouse button
7
Corner Lights LED
7
DVD-Drive8
USB-Interface8
RFID-Reader8
LiveCam 9
Camera 9
Camera Arm 10
Camera Handle 10
Castors10
IO-Panel10
Monitor SM-4
10
Monitor Arm
10
Computer10
Mouse Pad
11
Interface Box
11
Lock/Unlock
Castor Brakes
11
Lock/Unlock Camera Arm
11
Lock11
Unlock12
Lock/Unlock Monitor Arm
12
Lock12
www.stryker.com 1
Unlock12
Move Camera Arm
13
Move Monitor Arm
13
Set up System for Park Position
13
Park Position NAV3i Platform
Swivel Monitor/IO-Tablet
13
14
Change Monitor Settings
14
Set Loudspeaker Volume
15
Activate/Deactivate Mute State
Use IO-Tablet Tools
15
15
Save Patient Data
Transport Unpacked
15
16
Uninterruptible Power Supply (UPS)
16
Set up Operating Room
17
Set up System
18
Intraoperative Use
19
Shut down System
19
Transport and Store Packed
19
Cleaning and Inspection Instructions
19
Troubleshooting20
Service21
Update McAfee VirusScan
Use Remote Access for Service
21
22
Enable Remote Access
22
Open a Remote Access Connection
22
Service Data Collection
22
Disposal22
IO-Panel23
Technical Specifications NAV3i Platform*
24
Symbol Definitions
26
Label Definitions
31
Guidance and manufacturer's declaration
32
2
www.stryker.com
RFID Technical Specifications
39
RFID Conformity US
40
RFID Conformity Europe
41
RFID Conformity Australia/New Zealand
42
China RoHs
44
www.stryker.com 3
WARNINGS
• Read and understand this information. Familiarization with the
Stryker® Navigation System prior
to its use is important. Contact
your Stryker Navigation sales
representative for more detailed
information.
• This system is intended for use by
healthcare professionals only.
• Performing procedures with the
system other than those specified
in these instructions or outside of
its intended use will compromise
the navigation accuracy.
• Before using any component
compatible with the system, read
and understand the instructions.
Pay special attention to the user/
patient safety information provided
in the instructions for use supplied
with the individual components.
Failure to comply may result in
patient and/or operating room staff
injury or damage to the system
components.
• DO NOT modify the system or any
component or accessory. Failure
to comply may result in patient
and/or health care staff injury.
• To prevent the system from tipping over, do not lean against the
system, overload the drawer or
mousepad or add any weight to
the system.
• Before using the system take
care of power loss mitigation. The
integrated uninterruptible power
supply is not intended for use during surgery.
4
• This system may cause radio
interference or may disrupt the
operation of nearby equipment.
The system itself may be interfered by other nearby equipment
or mobile HF equipment (e.g.
cellular phone). Do not use the
system stacked or adjacent other
devices. It may be necessary to
take mitigation measures, such
as re-orienting or relocating the
system or shielding the location.
For EMC technical specifications
of the system refer to the related
chapter in this document.
• To avoid the risk of electric shock,
this system must only be connected to a mains supply with protective earth.
• To ensure the safe disconnection
of the system from the mains supply, never position the system so
that it is difficult to access the plug
of the main power cable or the
power outlet.
• Accessory equipment connected
to the analog and digital interfaces
must be certified according to the
respective IEC standard (e.g. IEC
60950 for data processing equipment or IEC 60601-1 for medical equipment). Furthermore, all
configurations must comply with
the system standard IEC 606011:2005, Clause 16.
Any person who connects additional equipment to the signal input
part or signal output part configures a medical electrical system,
and is therefore responsible for
ensuring that the system complies
with the requirements of the syswww.stryker.com
tem standard IEC 60601 1:2005
about connecting the system to the
network or with other equipment.
Clause 16. Contact your Stryker
Navigation sales representative for • Electric shock hazard. DO NOT
open the system. The system is
more detailed information.
equipped with an uninterruptible
power supply (UPS). DisconnectWARNINGS
ing plug does not remove UPS
• Connecting the system to the netoutput power. If disposal or service
work or with other devices via data
is required, contact your Stryker
coupling may result in comproNavigation sales representative.
mising the essential performance
•
Prior to each use, the system
of the system caused by e. g.
should be checked for loose
viruses, data loss, corrupt files,
components and damage. DO
unauthorized access. Data couNOT use if these conditions exist.
plings of the system are the USB
If service is required, contact your
interface, the CD/DVD drive and
Stryker Navigation sales representhe video interfaces.
tative immediately.
Before connecting the system to
network or to other equipment via
data coupling, identify, analyze,
CAUTIONS
evaluate and control the resulting
• Do not use any part of the system
risks.
All changes to the network or data
for loading, transport or storage
coupling, e.g.
unless otherwise specified. Failure
-- changes in the network or data
to comply may lead to product
coupling configuration
damage and malfunction.
-- the connection/disconnection
• Do not plug in or out any devices
of items from/to the network or
during the procedure.
data coupling
• Ensure that imported data are virus
-- the update/upgrade of equipfree.
ment connected to the network • Patient data protection may be
or data coupling
subject to a law in your country
may result in new risks.
(e. g. HIPAA). Ask your responAlways perform a new analysis of
sible authority for further informathe resulting risks when there are
tion about the patient data security
changes in the network or data
coupling.
in your country. Set a password
Do not connect equipment other
when logging on for the first time
than storage media to the USB
and change the password periodiinterface.
cally to avoid unauthorized access
Refer to the user documentation of
to patient data. At delivery the systhe applications for more information of connecting items to the
tem is not protected by password.
system.
Ask your Stryker Navigation sales
Contact your Stryker sales reprepresentative for more informaresentative if you have questions
tion about password settings.
www.stryker.com 5
• Caution: Federal law restricts this
device to sale by or on the order
of a physician.
Indications for Use
The NAV3i Platform is a computer
workstation that, when used with
specific Stryker Navigation surgical
software, displays patient specific
images and/or patient specific
anatomical landmark information
and tracks the position and
movement of surgical instruments in
relation to a target anatomical site
on a patient.
The clinical setting and target
population for the NAV3i Platform
is that of a patient undergoing
a surgical procedure using
stereotactic techniques.
Contraindication
The NAV3i Platform is not intended
for use in a MRI environment. The
NAV3i Platform is MR unsafe.
Essential Performance
of the NAV3i Platform
The NAV3i Platform runs Stryker
application modules within defined
application related specifications
and displays calculated position
and/or navigation information (image based and model based) within
application specific accuracy on a
screen in an operating room system, where a displayed incorrect
positional information outside the
needed accuracy could lead to an
6
incorrect response by the medical
staff that would present an unacceptable risk to the patient.
The NAV3i Platform provides online
positional tracking information
within defined actuality ( ≤ 4s) if
tracked instruments are located in
the working volume and line of sight
is maintained, where information
outside the needed actuality could
lead to an incorrect response by the
medical staff that would present an
unacceptable risk to the patient.
Overview NAV3i
Platform
The NAV3i Platform consists of
the following components. Refer to
figure 2:
A
Castor with brake and cable
guide
BCart
CComputer
DIO-Panel
EDrawer
FIO-Tablet
G
Camera arm
H
Camera handle
ICamera
J
Monitor arm
K
Monitor arm lock
L
Cable support
M
Interface box
N
Camera arm lock
OLiveCam
PMonitor
Q
Cart handle
R
Mouse pad
www.stryker.com
IO-Tablet
The IO-Tablet is a user interface
based on a touchscreen. It contains
four buttons, lights and several
interfaces as described below.
Main Power button
The Main Power button has two
indicator lights.
• The green lights indicate that the
power is on and the system is
running.
• The red lights indicate that the
power cable is connected, the
power is off and the system is not
running.
Refer to figure 3, C.
The IO-Tablet is not diagnosticgrade. Do not use it for diagnoses.
Virtual Keyboard button
The Virtual Keyboard button starts
a virtual keyboard on the touchscreen for a convenient data input.
The Virtual Keyboard button has
one green indicator light.
• The green light indicates the activated virtual keyboard.
Refer to figure 3, E.
Touch Lock button
The Touch Lock button locks and
www.stryker.com unlocks the touchscreen of the
IO-Tablet. When the touchscreen is
locked, no touch interaction is possible. The Touch Lock button has
one red/green indicator light.
• The red light indicates a locked
touchscreen.
• The green light indicates an unlocked touchscreen.
Refer to figure 3, F.
Right Mouse button
The Right Mouse button enables
the functions of the right mouse
button menu when touching the
IO-Tablet screen. After choosing
a function, the right mouse button
function will be disabled automatically. The Right Mouse button has
a green indicator light.
• The green light indicates the enabled right mouse button function.
Refer to figure 3, D.
Corner Lights LED
The two yellow LEDs indicate the
system state at the setup procedure
and during operation.
• LEDs flash once after power supply is connected and after pushing
the power button.
• LEDs flashing several times during setup procedure indicate a
booting failure. Refer to chapter
Set up System.
• LEDs flashing several times during procedure indicate an unexpected system state. Refer to
chapter Troubleshooting.
7
Refer to figure 3, B.
DVD-Drive
Used for data transfer on digital versatile disc or compact discs. Refer
to figure 3, A.
USB-Interface
Used for data transfer via USBmemory. Refer to figure 4, A, B.
RFID-Reader
The RFID-reader enables the use of
a license for the activation of a software package (e.g. Knee Navigation
or Hip Navigation).
The license for the software activation is stored on a license card. To
start a single case licensed application, insert the license card in the
RFID-reader slot.
The RFID-reader is disabled when
delivered. To enable the RFIDreader, ask your Stryker sales
representative for the RFID-reader
enable kit.
Refer to figure 4, C.
Figure 3
B
C
D E F
B
A
8
www.stryker.com
A
B
C
LiveCam
If supported by the application, the
LiveCam allows the easy positioning
of the camera via live view.
Camera
Figure 4
The camera identifies the location and orientation of one or more
instruments in three-dimensional
space. It communicates the coordinate location of the navigated
instruments. For more information,
refer to the instructions for use of
the camera.
A
HDMI
B
DVI
C
VGA
D
Figure 5
www.stryker.com 9
Camera Arm
Refer to figure 5.
The camera arm enables the positioning of the camera at the desired
position.
A
B
C
D
Camera Handle
Use the camera handle to align the
camera with the patient and instruments.
Castors
The castors are equipped with cable
guards.
IO-Panel
The IO-Panel contains interfaces
for video (HDMI, DVI, VGA) and
FireWire.
When connecting an external monitor to the video output sockets, the
monitor must have a native resolution of 1920 x 1080 pixels. Ensure a
distortion-free display of the external
monitor, identical to the system
monitor.
A B
C
D
HDMI socket
DVI socket
VGA socket
FireWire socket
Monitor SM-4
The monitor displays information
for the surgeon and operating room
staff during the surgical procedure.
The monitor is not diagnostic-grade.
Do not use it for diagnoses.
Monitor Arm
The monitor arm enables the positioning of the monitor at the desired
position.
Computer
The computer is the core of the
system.
E
F
G H
Figure 6
10 www.stryker.com
Mouse Pad
A mouse pad is attached to the
system for the convenient use of a
mouse. Slide out the mouse pad for
use.
Interface Box
The interface box contains interfaces for video (BNC, S-Video), USB
and Local Area Network (LAN) connections and the main power button
of the system.
Refer to figure 6.
A
Equipotentiality Connector
BBNC
CS-Video
D
USB 1/USB 2
E
LAN 1
F
LAN 2
G
On/Off (Main pushbutton)
H
Red/green LED
• The green LED indicates that the
power is on and the system is
running.
• The red LED indicates that the
power cable is connected, the
power is off and the system is not
running.
Lock/Unlock
Castor Brakes
The castors are equipped with castor brakes.
• Move the castor brakes to the
lower position to lock castors.
• Move the castor brakes to the
upper position to unlock castors.
Refer to figure 7.
Figure 7
Lock/Unlock Camera
Arm
Lock
1 Move the camera arm into the
locking position as shown in
figures 8 and 13. Check that
the indicator locking position is
matching as shown in figure 12.
2 Rotate the camera arm lock into
the lock position
as shown in
figure 9
3 Turn the camera into locking
position. (Camera must face
towards the IO-Tablet as shown
in figure 8). Check that the
indicator locking position is
matching as shown in figure 12.
www.stryker.com 11
Unlock
1 Push the camera arm lock
release button. Refer to figure
9, pos. A.
2 Rotate the camera arm lock into
the unlock position
in figure 10.
as shown
A
Figure 9
Lock/Unlock Monitor
Arm
Figure 10
Lock
1 Move the monitor arm into the
locking position as shown in
figures 8 and 13.
2 Push the monitor arm lock into
the lock position as shown in
figure 11.
Figure 11
Unlock
Carefully grab the monitor with both
hands at the left and right corner of
the lower side and pull it out of the
monitor arm lock.
Figure 12
Figure 8
12 www.stryker.com
Move Camera Arm
1 Unlock the camera arm.
2 Grab the camera handle.
3 Carefully move the camera to
the desired position.
Move Monitor Arm
1 Unlock the monitor arm lock
2 Grab the monitor.
3 Carefully move the monitor to
the desired position.
www.stryker.com Set up System for Park
Position
The park position is a defined position of the system that allows for
safe transportation and storage.
Park Position NAV3i Platform
Refer to figure 13.
1 Save data and shut down the
system. (Not necessary for
short duration transport. Refer
to chapter "Uninterruptible
Power Supply (UPS)".
2 Lock all castor brakes.
3 Slide in the mouse pad
completely.
4 Store the mouse in the drawer
and slide in the drawer.
5 Swivel the IO-Tablet into lower
position.
6 Unplug the power cable.
7 Wind up the power cable on the
cable support and fixate it with
the cable clip.
8 Unplug other cables, if
connected (e. g. network, video)
9 Lock the camera arm.
10 Lock the monitor arm.
13
Swivel Monitor/IO-Tablet
• Swivel monitor and IO-Tablet
gently.
• Do not swivel the IO-Tablet while
the system is reading data from
CD/DVD.
Change Monitor
Settings
The monitor settings for input
source, image settings, setup, VGA,
sound and status can be changed
with the monitor menu.
1 Press the MENU button on the
left side of the monitor to open
the monitor menu.
2 Navigate inside the menus and
change settings with the RIGHT
or LEFT buttons.
3 Press the MENU button to enter
the submenus.
Figure 13
• The monitor menue will close automatically after some seconds.
• The POWER button and the
AUTO button are disabled.
14 www.stryker.com
Set Loudspeaker
Volume
1 Press the MENU button on the
left side of the monitor to open
the monitor menu.
2 Select the menue Sound with
the LEFT or RIGHT button
3 Press the MENU button again
to enter the submenue Volume.
4 Press the MENU button again
to enter the volume setting.
5 Adjust the desired volume by
clicking the LEFT or RIGHT
button.
Activate/Deactivate Mute State
1 Press the MENU button on the
left side of the monitor to open
the monitor menu.
2 Select the menue Sound with
the LEFT or RIGHT button
3 Press the MENU button again
to enter the submenue an select
Mute by clicking the LEFT or
RIGHT button.
4 Press the MENU button again
to enter the submenue.
5 Chose the desired mute state
(On/Off) by clicking the LEFT or
RIGHT button.
www.stryker.com Use IO-Tablet Tools
The IO-Tablet tools can be used only
after the system setup was performed and the system is running.
• Select the Tools Tab on the IOTablet.
• Click the Restore Display Settings button if you want to restore
display settings for IO-Tablet and
monitor.
• Click the Burn CD/DVD button if
you want to save patient data on
CD/DVD.
• Click the Eject USB Drive button
if you want to eject USB memory.
• Select the Applications Tab to
return to the applications menu.
Save Patient Data
• Click the Burn CD/DVD button.
The burning application starts.
• Select Data and Data Disc.
• Click the Add button.
The Files and Folders dialog
opens.
• Open the desired folder (e.g. D:\Application
Folder\"application"Data/Patients).
• Select desired patient data.
• Click the Add button.
• Click the Finished button.
• Click the Next button.
• Click the Burn button. The process starts.
• After the process is completed,
close all dialogs and click the Exit
button to close the burning application.
15
Transport Unpacked
WARNINGS
• To avoid user injury and/or product
damage, ensure that the system is
in the park position and the power
cable is stored during transport
or storage. For short duration
transport of the the system can
be transported without a system
shutdown.
• To avoid user injury and/or product
damage, unlock the castor brakes
before moving the system and lock
brakes after moving.
• To avoid user injury and/or product damage, avoid rolling over
cables or other obstacles. When
necessary, use a ramp for crossing obstacles. Alway check the
castors for damage after crossing
obstacles. If the castors are damaged, contact your Stryker sales
representative immediately.
• The handle of the system is not
intended to be used as a suspension point for lifting the system.
Lifting the system at the handle
may result in injury or lead to system damage and malfunction.
• Move the system slowly and
carefully.
• If the system is transported indoor
after outdoor placement, wait two
hours prior to use. Otherwise, condensed water on the components
could compromise proper functioning of the system.
1 Move the system into the park
position (Refer to chapter Set
up System for Park Position).
2 Unlock all castor brakes
(Figure 7).
3 Grab the cart handle (Figure 2,
Pos. Q) to move the system.
4 Lock the castor brakes after
moving.
Uninterruptible Power
Supply (UPS)
The system is equipped with a UPS
that allows you to transport the
system for a short duration without a
shutdown (max. six minutes).
For optimal performance the battery
should be always fully charged. This
is accomplished by plugging the system to power supply for eight hours.
WARNINGs
• Do not use the system in OR without the power supply plugged in.
Using the system without plugged
in power supply may lead to system shutdown during procedure.
The uninterruptible power supply is
intended only for a short duration
transport of the system.
• If the system is connected to other
devices, the devices must be disconnected before using the UPS
function. Failure to comply may
result in patient and/or health care
staff injury.
16 www.stryker.com
Set up Operating Room
tem together with the navigated
instruments and other connected
devices to ensure the equipment
functions properly.
WarningS
•
To avoid injury and/or product
• Do not place the system near
damage move the camera arm
equipment that generates a magand monitor arm slowly. Pay atnetic field. Stored patient data may
tention not to bruise your fingers/
be erased.
hands.
• To prevent overheating, do not
• To avoid injuries to fingers and/or
place the system in proximity of
hand, use the camera handle for
heat sources such as radiators or
repositioning the camera.
air ducts.
•
The system is not built as a re• Excessive infrared radiation from
dundant system. Prior to planning
external sources may influence
a procedure consider the unlikely
localization of the instruments by
event that the system may be
the system. Refer to the camera's
unavailable and therefore plan for
instructions for use.
alternative tools and techniques to
• The system is not suitable for use
be able to finish surgery successin the presence of flammable anfully without the use of navigation.
esthetic mixture with air, oxygen,
or nitrous oxide or for outside use.
1 Position the system as shown in
• Prior to each use, the system
figure 14.
should be checked for loose
2 Lock the castor brakes.
components and damage. DO
(Refer to figure 7).
NOT use if these conditions exist.
3 Unlock
the camera arm.
If service is required, contact your
Stryker Navigation sales represen- 4 Unlock the monitor arm.
tative immediately.
5 Orient the camera and the
• Clean the system before first and
monitor towards the operating
every use. Refer to the cleanroom table as shown in figure
ing instructions contained in this
14.
manual.
• Check camera cables, monitor
cables, IO-Tablet cables, power
supply and other cables (e. g.
video input) for proper fit of the
connectors and damages before
first and every use. The system
may not operate when cables are
not connected or damaged.
• Prior to surgery, check the syswww.stryker.com 17
Set up System
Figure 14
1 Plug in the network cable if
network connection is desired.
2 Plug in the power cable. Check
that the corner lights flash once,
if system was not running on
UPS before. If the corner lights
do not flash once, contact your
Stryker sales representative.
3 Push the Power button.
4 Check the yellow Corner Light
LEDs on the IO-Tablet during
system start. If the LEDs are
flashing continuously, shut
down the system and restart.
If the LEDs are flashing again,
contact your Stryker Navigation
sales representative.
5 Select your user profile and log
in.
6 Start the desired application by
selecting it on the IO-Tablet.
CAUTION
• While typing in your password
during log in, the virtual keyboard
is visible on the the monitor. So
the password may be guessable
for persons nearby. Assure that
the monitor is not visible for other
persons during log in.
18 www.stryker.com
Intraoperative Use
WARNINGS
• The system is not sterile. The
surgeon must not operate it during the procedure. The system
should not come in contact with
the patient. Prior to use clean as
instructed in this manual. Failure
to comply may lead to contamination.
• Prior to surgery, start and set up
the system.
1 Disinfect the camera handle
before using it to reposition the
camera.
2 The IO-Tablet, respectively
monitor, can be used for data
input or visualization outside the
sterile surgical field.
Shut down System
1 Click Exit to close the
application.
2 Click Exit and Shutdown or
press the IO-Tablet Power
button and click Shutdown to
shut down the system.
3 Wait until system is shut down.
4 Move the system into park
position.
Transport and Store
Packed
For long distance transport and long
term storage it is recommended to
pack the system into the transport
box. Refer to the chapter Technical
Specification for the transport and
storage conditions.
WARNING
• To avoid operating room staff injury and/or product damage, ensure
that the system is in park position
when transported and stored.
Cleaning and Inspection
Instructions
Manual cleaning is recommended.
CAUTIONS
• DO NOT use solvents, lubricants,
or other chemicals unless otherwise specified.
• DO NOT allow moisture in any
opening or on the power cable.
Fluids/moisture may damage the
electrical components. Spilling
liquids on any electrical device attached to the system should warrant inspection by an authorized
Stryker service technician.
Supplier
Agent
Dilution
2%
Ecolab
Incidin
None Isopropyl alcohol 70%
®
Table 1: Tested Cleaning Agents
www.stryker.com 19
Cleaning Instructions
1 Clean the whole surface of the
system only if required.
2 For the camera, refer to the
cleaning recommendations
included in the instructions for
use supplied with the Camera.
3 Carefully wipe the surface using
a lint-free soft cloth dampened
with a non-abrasive and mild
detergent.
Inspection Instructions
After cleaning, visually inspect
the system under good light
conditions for remaining debris.
Repeat cleaning procedure again if
required. Refer to the instructions
for use for the camera for inspection
recommendations related to the
camera.
Troubleshooting
Monitor is not working:
• The power cable/monitor cable is
not connected, defective or loose:
Call for service if required.
• System is switched off: Switch on
the system.
• Fuse has blown or there is another
electrical problem: Call for service.
Unable to move camera/monitor
arm:
• Camera/monitor arm is locked,
unlock camera arm
• Mechanical fault: Call for service.
There is no system sound:
• The mute state is activated: Deactivate the mute state. Refer to
chapter Set Loudspeaker Volume.
Corner Light LEDs not flashing:
• After connecting the power supply
or after pressing the power button
the LEDs must flash once. If the
LEDs are not flashing once: Call
for service.
System has no network access:
• Check network cable/connectors.
LiveCam is not working:
• LiveCam/connection is defective.
Call for service.
• Communication with the LiveCam
fails due to voltage drop. Ensure
that external power is restored.
• Check that LiveCam is supported
by the software.
20 www.stryker.com
Camera is not working:
• Power cable/firewire cable is not
connected, defective or loose.
Check connections and restart
system. If the problem persists,
call for service.
• Camera/connection is defective.
Call for service.
• Communication with the camera
fails due to voltage drop. Ensure
that external power is restored.
There is no image on the monitor
even though it is switched on.
• Log out and log in to the system.
• Restore display settings.
System will not roll for transport:
• Castors are locked. Unlock
castors.
Corner Light LEDs are flashing
continuously:
• If licensing is unsuccessfull,
contact your Stryker Navigation
sales representative.
Service
WARNING
• DO NOT service the system. It
contains no parts the user can
service. If service is required,
contact your Stryker Navigation
sales representative.
• Electric shock hazard. DO
NOT open the system. The
system is equipped with an
uninterruptible power supply
(UPS). Disconnecting plug does
not remove UPS output power.
If disposal or service is required,
contact your Stryker Navigation
sales representative.
Update McAfee VirusScan
The NAV3i Platform is equipped
with a McAfee Virus Scanner to
safeguard the computer system
from viruses and other malware. To
guarantee the most current virus
System is not starting:
protection, the virus definition files
must be updated periodically. Please
• Uninterruptible power supply is
contact your Stryker Navigation
empty. Connect the system to
sales representative for updates. A
the power supply for ten minutes.
Then try to start the system, again. license for these updates is included
• If the system is still not starting call for two years, after that period of
time, it must be renewed. For the
for service.
renewal of the license, contact
Licensing through RFID is not
your Stryker Navigation sales
working:
representative.
• Make sure RFID is activated.
• Use contingency license model
and type in license by hand.
• If the LEDs are flashing
continously, shut down the system
and restart. If the LEDs are
flashing continously again: Call for
service.
www.stryker.com 21
Use Remote Access for
Service
The system is equipped with the
remote access functionality.
This enables you to share the
access to the system by the network
connection for remote service by
Stryker.
The remote access is available in
USA only.
CAUTION
Enabled remote access may cause
unauthorisized access to your system via network.
• Set a new password when logging
on for the first time and change the
password periodically to avoid unauthorized access to the system.
At delivery the system is protected
by a default password and the remote access is disabled. Ask your
Stryker Navigation sales representative for more information about
remote access.
• Always ensure that remote access
is disconnected if remote access is
not desired.
• Disconnect the network from the
system if connection is not desired.
CAUTION
Remote access during a procedure
may slow down system responsiveness. Consider this prior to initiating
or accepting remote access.
Enable Remote Access
The remote access is disabled when
delivered. To enable the remote
access, ask your Stryker Navigation
sales representative.
Open a Remote Access
Connection
• Call your Stryker sales representative to schedule the remote access
connection.
• Ensure that the system is switched
on and the network connection is
enabled before starting the remote
access connection.
• Do not log in.
Service Data Collection
For enhanced service quality, the
system will collect service data and
transfer them to Stryker, if remote
access is enabled. These service
data are non-personal. No patient
data will be transfered.
Transfered data are:
• System Name
• Available Disk Space
• System Date
• System Report Files
Disposal
Disposal may be subject to special
regulations in your country.
Please contact your Stryker sales
representative for a safe and convenient disposal.
22 www.stryker.com
Warning
• Electric shock hazard. DO NOT
open the system. The system is
equipped with an uninterruptible
power supply (UPS). Disconnecting plug does not remove UPS
output power. If disposal or service
is required, contact your Stryker
Navigation sales representative.
IO-Panel
The IO-Panel contains interfaces
for video (HDMI, DVI, VGA) and
FireWire.
Refer to figure 5.
A
B
C
D
HDMI socket
DVI socket
VGA socket
FireWire socket
www.stryker.com 23
Technical Specifications NAV3i Platform*
REF 7700-800-000
Dimensions
(System in
Park Position)
1920 mm [75.59 in.] height
Weight
250 kg [551,16 lbs]
Material
Aluminium, stainless steel, plastics, rubber
Electrical
Characteristics
Equipment Type: Class 1
Power Supply:
220-240V ~50-60Hz 2.4A
100-120V ~50-60Hz 5.2A
520W
The main supply voltage fluctuations are not
to exceed 10 percent of the nominal supply
voltage.
The equipment must be connected to a centertapped single phase supply circuit when
connecting the equipment to a 240 V supply
system.
720 mm [28.35 in.] width
960 mm [37.8 in.] length
Classification according to CISPR 11:
Group 1, Class A
This product is only authorized for indoor use.
Approvals
EN / IEC 60601-1
EN / IEC 60601-1-2
ANSI/AAMI ES60601–1:2005
CAN/CSA-C22.2 No. 60601-1:08
* Specifications listed are approximate and may vary slightly from unit to unit. Standards listed
are valid unless a transition period may be applicable.
24 www.stryker.com
Technical Specifications NAV3i Platform (cont'd)*
REF 7700-800-000
Operation
1060 hPa
700 hPa
30°C
Non condensing
10°C
Unpacked storage
1060 hPa
700 hPa
Non condensing
Packed storage and transportation
1060 hPa
700 hPa
Non condensing
* Specifications listed are approximate and may vary slightly from unit to unit. Standards listed
are valid unless a transition period may be applicable.
www.stryker.com 25
Symbol Definitions
Symbol
Definition
This is the general warning sign. It is used to alert the user
to potential hazards. All safety messages that follow this
sign shall be obeyed to avoid possible harm.
Federal Communications Commission
CSA International
Date of Manufacture
Manufacturer
In accordance with European Directive 2002/96/EC on
Waste Electrical and Electronic Equipment, this symbol
indicates that the product must not be disposed of as
unsorted municipal waste. The product should be collected
separately. Refer to your local distributor for return and/or
collection systems available in your country.
C1275
Essential Requirements of Medical Device Directive
93/42/EEC.
Not sterile
To ensure safety, refer to instructions for use.
26 www.stryker.com
Symbol Definitions (cont'd)
Symbol
Definition
1060 hPa
Atmospheric pressure limitation
700 hPa
Humidity limitation
30°C
Temperature limitation
10°C
Power on/off (Main power button)
Virtual keyboard button
Right mouse button
Touch lock button
Alternating current
www.stryker.com 27
Symbol Definitions (cont'd)
Symbol
Definition
Equipotentiality
MENU
Monitor menu
Monitor menu up
Monitor menu down
AUTO
Monitor menu automatic source (Disabled)
Monitor power off/on (Disabled)
Consult instructions for use
Move cart slowly
.
28 www.stryker.com
Symbol Definitions (cont'd)
Symbol
Definition
Universal Serial Bus (USB)
Locking Position
Unlocking Position
Network
Protective Earth
FireWire
Video In
Video Out
Power Button
www.stryker.com 29
Symbol Definitions (cont'd)
Symbol
Definition
Electrical Potential - Do not open
MR
MR unsafe
Non-ionizing electromagnetic radiation
30 www.stryker.com
Label Definitions
Label
Definition
Camera arm lock label.
Camera arm lock locking or unlocking
position. This label shows the state of
the camera arm lock.
2
1
1
2
3
3
Parking position Label.
This label shows the correct parking
position of the system.
Indicator locking postion
MAX. 5 kg
Maximum load drawer 5 kg
MAX. 2 kg
Maximum load mousepad 2 kg
www.stryker.com 31
Guidance and manufacturer's declaration
Electromagnetic Compatibility
Guidance and manufacturer's declaration
Electromagnetic emissions
The Stryker NAV3iTM Platform is intended for use in the electromagnetic environment specified below. The customer or the user of the Stryker NAV3iTM Platform
should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment –
guidance
RF emissions CISPR 11
Group 1
The Stryker NAV3iTM Platform 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 11
Class A
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
The Stryker NAV3iTM Platform is suitable for use in all establishments
other than domestic and those connected to a low voltage power supply
network which supplies buildings
used for domestic purposes.
32 www.stryker.com
Guidance and manufacturer's declaration
Electromagnetic immunity
The Stryker NAV3iTM Platform is intended for use in the electromagnetic environment specified below. The customer or the user of the Stryker NAV3iTM Platform
should assure that it is used in such an environment.
Immunity Test
IEC 60601 test
level
Compliance level
Electromagnetic
environment –
guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be
wood, concrete or
ceramic tile.
If floors are covered
with synthetic material, the relative
humidity should be
at least 30 %.
Electrical fast transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±2 kV for power
supply lines
±1 kV for input/
output lines
±1 kV for input/
output lines
Mains power quality
should be that of a
typical commercial
or hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±2 kV line(s) to
earth
www.stryker.com Mains power quality
should be that of a
typical commercial
or hospital environment.
33
Immunity Test
IEC 60601 test
level
Compliance level
Electromagnetic
environment –
guidance
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
< 5 % UT (> 95 %
dip in UT) for 0,5
cycle
< 5 % UT (> 95 %
dip in UT) for
0,5 cycle
40 % UT (60 % dip
in UT) for 5 cycles
40 % UT (60 % dip
in UT) for 5 cycles
< 5 % UT (> 95 %
dip in UT) for 5 sec
< 5 % UT (> 95 %
dip in UT) for 5 sec
Mains power quality
should be that of a
typical commercial
or hospital
environment. If the
user of the Stryker
NAV3iTM Platform
requires continued
operation during
power mains
interruptions, it
is recommended
that the Stryker
NAV3iTM Platform
be powered from
an uninterruptible
power supply or a
battery.
3 A/m
3 A/m
Power
frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
70 % UT (30 % dip
in UT) for 25 cycles
70 % UT (30 % dip
in UT) for 25 cycles
Power frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment
Note: UT is the a.c. mains voltage prior to application of the test level.
34 www.stryker.com
Guidance and manufacturer's declaration
Electromagnetic immunity
The Stryker NAV3iTM Platform is intended for use in the electromagnetic environment specified below. The customer or the user of the Stryker NAV3iTM Platform
should assure that it is used in such an environment.
Immunity
Test
IEC 60601 test
level
Compliance
level
Electromagnetic environment – guidance
Portable and mobile
RF communications
equipment should be used
no closer to any part of the
Stryker NAV3iTM Platform,
including cables, than the
recommended separation
distance calculated from
the equation applicable
to the frequency of the
transmitter.
Recommended
separation distance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
www.stryker.com 3V
d = 1.2 P
35
Immunity
Test
IEC 60601 test
level
Compliance
level
Radiated RF
ICE 61000-4-3
3 V/m
80 MHz to 2,5 GHz
3 V/m
Electromagnetic environment – guidance
d = 1.2 P
d = 2.3 P
80 MHz
to 800
MHz
800 MHz
to 2,5
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
metres (m).
Field strengths from
fixed RF transmitters,
as determined by an
electromagnetic site
survey,a should be less
than the compliance level
in each frequency range.b
Interference may occur in
the vicinity of equipment
marked with the following
symbol:
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
36 www.stryker.com
a
Field strengths from fixed transmitters, such as base stations for radio (cellular/
cordless) telephones 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 Stryker NAV3iTM Platform is used exceeds
the applicable RF compliance level above, the Stryker NAV3iTM Platform should
be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the
Stryker NAV3iTM Platform.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/m.
www.stryker.com 37
Recommended separation distances between portable and mobile
RF communications
equipment and the Stryker NAV3iTM Platform
The Stryker NAV3iTM Platform is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer
or the user of the Stryker NAV3iTM Platform can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the Stryker NAV3iTM Platform
as recommended below according to the maximum output power of the
communications equipment.
Rated maximum
output power of
transmitter
Separation distance according to frequency of
transmitter
m
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz
to 2,5 GHz
W
d = 1.2 P
d = 1.2 P
d = 2.3
P
0,01
0,12
0,12
0,23
0,1
0,38
0,38
0,73
1
1,2
1,2
2,3
10
3,79
3,79
7,27
100
12
12
23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (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: At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
Note 2: These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, objects and
people.
38 www.stryker.com
RFID Technical Specifications
Technical Specifications RFID
Feature
Specification
Function
RFID is used for Navigation Software license
management.
The license is stored in a passive RFID card.
Standard conformance
ISO 15693
47 CFR Part 15 Subpart C
Frequency range
13,56 MHz
Data rates
106 Kb/s up to 847 Kb/s
Operation distance
< 5 cm
Modulation
A1D (Amplitude modulation)
Spectrum 99% = 134 kHz
Transfer power
115 µW
Emission
57,1 dbµV/m at 3m
Quality of service and security recommendations
When using the RFID Reader ensure that no other
radio frequency devices using the same frequency
and modulation are in the vicinity of the NAV3i
Platform. These devices might not work or may
disturb the NAV3i Platform RFID functionality. If
such devices cannot be avoided, the NAV3i Platform
RFID Reader shall be deactivated and an alternative
license model shall be used.
No precautions are necessary by the user to ensure
security.
US Approval
www.stryker.com FCC approval with FCC ID QYERDR41X
39
RFID Conformity US
40 www.stryker.com
RFID Conformity Europe
EG-Konformitätserklärung
Hersteller 1 Adresse:
Manufacturer
I EC Declaration of Conformity
ads-tec GmbH
Raiffeisenstr.14
I Germany
70771 Leinfelden-Echterdingen
/ Address:
Produktbeschreibung:
DVG- NAVIIIPAD-004-AA
Modell 1 Model:
Productdescription:
Das oben beschriebene Produkt stimmt in der von uns in Verkehr gebrachten Ausführung mit den Bestimmungen
folgender Europaischer Richtlinien überein:
The product described
above in the form as delivered is in conformity
1999/5/EC
Richtlinie des Europaischen Parlaments und des Rates über Funkanlagen und
Telekommunikationsendeinrichtungen
und die gegenseitige Anerkennung ihrer Konformitat
with the provisions
of the foJlowing European Directives:
Directive of the European Parfiament and of the Council on radio equipment and telecommunications
and the mutual recognition of their conformity (Applies only for products with Radio-Communication)
Richtlinie des Europaischen Parlaments und des Rates zur Angleichung der Rechtsvorschriften
der Mitgliedstaaten über die elektromagnetische Vertraglichkeit
2004/108/EC
Directive of the European Parfiament and of the Council
to electromagnetic compatibility
Das oben beschriebene
The product of the declaration
EU harmonisierte
EU harmonized
terminal equipment
on the approximation
of the laws of the Member States relating
Produkt ist konform mit den Anforderungen der folgenden Dokumente:
described above is in conformity
with the requiraments
of the foJlowing documents:
Normen
Standards
SicherheitlSafety:
EN 60950-1 :2006 +A1 :2010; EN 50364:2010
EMV/EMC: EN 301 489-1 V1.8.1;
Funk/Radio:
Ort, Datum
Place and date of issue
Name und Unterschrift
Name and signature
EN 301 489-3 V1.4.1
EN 300 330-1 V1.7.1; EN 300 330-2 V1.5.1
Leinfelden-Echterdingen,
08/02/2012
~$=
- Quality Manager-
Diese Erklarung
Sicherheits- und
This declaration
the product shall
bescheinigt die Übereinstimmung
mit den genannten Richtlinien, ist jedoch keine Beschaffenheits- oder Haltbarkeitsgarantie
nach ~443 BGB. Die
Einbauhinweise der mitgelieferten Produktdokumentation
sind zu beachten.
certifies the conformity to the specified directives but does not imply any warranty for properties. The safety and installation documentation accompanying
be considered in detail.
www.stryker.com 41
RFID Conformity Australia/New Zealand
42 www.stryker.com
www.stryker.com 43
7700-842-000
7700-830-000
7700-616-000
7700-620-000
7700-550-000
7700-824-000
7700-851-000
7700-852-000
7700-853-000
7700-856-000, 7700-857-000, 7700-858-000
7700-055-000, 7700-065-000, 7700-075-000
7700-854-000
IO 平板电脑电线包 NAV3i
IO-Tablet Cable Kit NAV3i
显示器 SM-4,32 英寸
Monitor SM-4, 32 Inch
IO 平板电脑
IO Tablet
IO 平板电脑鼠标
IO Tablet Mouse
Stryker NAV3(TM) GRAPHITE 摄像机
Stryker NAV3(TM) GRAPHITE Camera
现场摄像机 NAV3i
Live Camera NAV3i
视频分割器 DVI-D-1:4
Splitter DVI-D-1:4
视频转换器 DVI-D/VGA
Video Converter DVI-D/VGA
隔离变压器
Isolation Ttransformer
电线包
Cable Kits
显微镜套件
Microscope Kits
不间断电源 NAV3i
Uninterruptible Power Supply NAV3i
o
o
o
o
o
o
o
o
o
o
o
x
o
o
o
o
o
o
o
o
o
o
o
o
o
汞
(Hg)
o
铅
(Pb)
o
o
o
o
o
o
o
o
o
o
o
o
o
镉
(Cd)
o
o
o
o
o
o
o
o
o
o
o
o
o
六价铬
(Cr6+)
o
o
o
o
o
o
o
o
o
o
o
o
o
多溴联苯
(PBB)
有害物质或元素
(Hazardous Substances or Elements)
o
o
o
o
o
o
o
o
o
o
o
o
o
多溴二苯醚
(PBDE)
defined in the Standard.
(企业可在此处,根据实际情况对上表中打“╳”的技术原因进行进一步说明。)x : Means the hazardous substances in at least one of the homogenous materials of the Unit exceed the concentration limits
x:表示有害物质至少在该部件的某一均质材料中的含量超出《标准》规定的浓度限值。
o :表示有害物质在所有均质材料中的含量在《标准》规定的浓度限值以下。o : Means the hazardous substances in all the homogenous material are below the concentration limits defined in the Standard.
7700-611-000
Stryker PC-3
Stryker PC-3
部件名称
(Component Name)
产品文件符合中国 RoHS 认证的要求
(Components for Navigation Systems. Product Documentation for Documentation Compliance with China RoHS Requirements)
导引系统部件
China RoHs
44 www.stryker.com
This page was intentionally left blank for your notes.
Translated Equivalent: TD7700800713
Stryker Corporation or its divisions or other
affiliated entities own, use or have applied for
the following trademarks or service marks:
Stryker, Stryker NAV3i.
All other trademarks are trademarks of their
respective owners or holders.
Copyright © 2013 Stryker
Printed in Germany
Manufactured and Distributed by:
Stryker Leibinger GmbH & Co. KG
Bötzinger Straße 41
79111 Freiburg, Germany
t: +49 761 4512 0
Distributed by:
Stryker Navigation
4100 East Milham Avenue
Kalamazoo, MI 49001 USA
t: +1 269 323 7700
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