Stryker Sidne Instruction manual

Sidne™ Manual Addendum
Visum Surgical Lights and
StrykeCAM Overhead Camera
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Contents
Sidne™ Manual Addendum
Visum Surgical Lights and StrykeCAM Overhead Camera ........................1
Ergänzung zum Sidne™-Handbuch
Chirurgische Beleuchtung Visum und Overhead-Kamera StrykeCAM .19
Anexo al manual del sistema Sidne™
Lámparas quirúrgicas Visum y cámara superior StrykeCAM ..................39
Addenda au manuel Sidne™
Lampes chirurgicales Visum et caméra suspendue StrykeCAM ..............59
Sidne™ Addendum al manuale delle lampade chirurgiche
Visum e della videocamera sospesa StrykeCAM ........................................79
Adenda ao Manual do Sidne™
Luzes Cirúrgicas Visum e Câmara Suspensa StrykeCAM ........................99
Addendum bij Sidne™ handleiding
Visum OK-lampen en StrykeCAM overheadcamera ..............................119
Sidne™ tillæg til vejledning
Visum operationslys og StrykeCAM overhead kamera ..........................137
Sidne™-järjestelmän käyttöoppaan liite
Kirurgiset Visum-valot ja StrykeCAM-yläkamera ...................................155
Bilaga till manual för Sidne™
Visum operationsbelysning och StrykeCAM overheadkamera .............173
Προσθήκη στο εγχειρίδιο του συστήματος Sidne™
Χειρουργικοί προβολείς Visum και υπερκείμενη κάμερα
StrykeCAM.....................................................................................................191
Sidne™ – Załącznik do instrukcji
Lampy operacyjne Visum i kamera podwieszana StrykeCAM ................213
Sidne™ 取扱説明書 補遺
Visum 手術用ライト／ StrykeCAM オーバーヘッドカメラ...................233
Sidne™ Manual Addendum Visum 手术灯及
StrykeCAM 头顶照相机 .............................................................................251
Sidne™ 설명서 부록
Visum Surgical Lights 및 StrykeCAM Overhead Camera ....................267

1
Sidne™Manual Addendum
Visum Surgical Lights and
StrykeCAM Overhead Camera
Connection and Operation Instructions
Product Description
The Kit contains the following items:
1. EDAM adapter cables (4)
2. Sidne™ interface cable (2)
3. Sidne™ Visum/StrykeCAM EDAM (1)
4. Visum/StrykeCAM EDAM Power Supply (1)
5. Hospital-grade AC Power cord (2)
6. User Insert (this manual)
7. Sidne™ Visum/StrykeCAM driver - USB dongle
Quick Start-Up Guide
This section is intended to give an outline of the start-up instructions for
experienced users. Refer to the relevant section(s) of this addendum for further
instructions.
1. Ensure that the Visum surgical light power box(es) and Sidne™ are
powered Off.
2. Connect each Visum surgical light power box to the Visum/StrykeCAM
EDAM.
a. Connect the EDAM adapter cable from the EDAM Light 1/Camera
port to the Power box Control 1 port.
b. Connect the EDAM adapter cable from the EDAM Light 2 port to
the Power box Control 2 port.
c. If you have second Power box, connect EDAM adapter cable from
EDAM Light 3 port to the second power box Control 1 port.
d. If you have second Power box, connect EDAM adapter cable from
EDAM Light 4 port to the second power box Control 2 port.
e. Connect the two Sidne™ interface cables to the EDAM ports for the
Sidne™ Light and Sidne™ Camera.
f. Connect the Sidne™ interface cables to Sidne™.

2
3. Connect the Visum/StrykeCAM EDAM Power Supply to the DC jack on
the EDAM at the top right. Plug in the female end of the Hospital-grade
AC Power cord to the Power Supply. Plug in the male end of the AC
Power cord to a hospital-grade electrical outlet.
4. Turn ON the power on the Visum Power box. Ensure that the camera on
the wall panel is turned ON.
5. Power On the Sidne™ console (If the two Sidne™ interface cables are
connected to Sidne and the EDAM and the Visum Power box is ON,
Sidne will make an announcement of "Unknown Device Connected").
6. Install the Visum/StrykeCAM driver upgrade.
7. Sidne™ will shutdown at the end of the upgrade. Power On the Sidne™
and wait for the unit to say "Sidne™ ready". Caution: Sidne™ should say
"O. R. Lights Connected" and "Overhead Camera Connected" and the
EDAM LED should be a steady orange within a minute of powering On
the Visum Power box. If the LED continues to flash orange after 30
seconds, refer to the "Troubleshooting Guide" of this addendum for
instructions.
This completes the installation procedure.
Connecting the Visum Power Box
Warnings and Cautions
Please read this addendum and follow its instructions carefully. The words
warning, caution, and note carry special meanings and should be carefully
reviewed:
WARNING The personal safety of the patient or physician may be
involved. Disregarding this information could result in
injury to the patient or physician.
Caution Special service procedures or precautions must be followed to
avoid damaging the instrument.
Note Special information to make maintenance easier or important
information more clear.
An exclamation mark within a triangle is intended to alert the user to the
presence of important operating and maintenance instructions in the lit-
erature accompanying the product.
A lightning bolt within a triangle is intended to warn of the presence of
hazardous voltage. Refer all service to authorized personnel.

3
WARNING To avoid potential serious injury to the user and the patient
and/or damage to this device, please note the following
warnings:
1. To avoid potential serious injury to the user and patient and/or damage
to this device, read the Visum Surgical Light and StrykeCAM In-Light
Camera operating manual thoroughly and be familiar with its contents
prior to using this equipment.
2. The Visum Surgical Light , StrykeCAM In-Light Camera and the Visum/
StrykeCAM EDAM (hereafter referred to as "EDAM") is designed to be
used by a qualified physician/technician familiar with its use. Misusing
the Visum Lights/StrykeCAM Camera may cause injury to the patient
and/or damage system components.
3. Carefully unpack the kit and check if any damage occurred during
shipment. If damage is detected, DO NOT use the equipment.
WARNING To avoid potential serious injury to the user and the patient
and/or damage to this device, please note the following
electrical warnings:
1. To prevent electrical shock to the patient and/or operating room
personnel, do not immerse the Visum Power Box or the EDAM or allow
fluid to enter the chassis or connector.
2. Before and after each use, inspect the cord insulation for cracks, nicks,
cuts, dents, or depressions. Any irregularity will decrease the insulation
effectiveness and may result in shocks to the patient and/or operating
room personnel.
3. To prevent injury or electrical shock to the patient and/or operating
room personnel, always power Off the Visum Power Box when
connecting or disconnecting accessories. Caution: To avoid potential
damage to this device, always power Off the Visum Power Box before
connecting or disconnecting the Sidne™ interface kit.

4
Setting up the EDAM
Note Ensure that the Visum Power box and the Sidne™ console are powered
OFF.
1. Connect the EDAM to the Control ports of on the Visum Power box
using the adapter cables as shown in Figure 1.
Figure 1: Connecting the device adapter cable to the StrykeCAM Overhead Camera's control
box
2. Connect the two Sidne™ interface cables to the ports marked "O. R.
Lights" and "Overhead Camera" located at the bottom left of the EDAM.
3. Connect the other end of the Sidne™ interface cables to two of the eight
USB ports on the Sidne™ console (see Figure 2).
Figure 2: Connecting the Sidne interface cable to Sidne™

5
4. Connect the Visum/StykeCAM EDAM Power Supply to the EDAM:
a. Plug in the Power supply's DC jack to the DC jack at the top right
of the EDAM.
b. Plug in the female end of the Hospital-grade AC Power cord to the
Power Supply.
c. Plug in the male end of the AC Power cord to a hospital-grade
electrical outlet.
The Sidne™ console is now connected to the StrykeCAM Overhead Camera.
Installing the Visum/StrykeCAM
Driver Upgrade
Note Read the “Notes on the Operation of the SIDNE-StrykeCAM
Overhead Camera Interface” section at the end of this procedure
before using the Sidne™ console to control the Visum Lights/
StrykeCAM Camera.
Note Do not attempt to install any other software driver until the
installation of the Visum/StrykeCAM Driver is complete and the
Sidne™ console has shutdown (after step 6 of this section).
The Sidne™ Visum/StrykeCAM Driver 1.0 upgrade allows the Sidne™ console to
communicate with the Visum Lights and the StrykeCAM Camera. Follow the
instructions below to install the Sidne™ Visum/StrykeCAM Driver 1.0 upgrade on
the Sidne™ console:
1. Power On the Visum Power box and the EDAM.
2. Power On the Sidne™ console and wait until Sidne™ says "Sidne ready." If
the Visum/StrykeCAM EDAM and the Visum Power box are ON then
Sidne will make an announcement of "Unknown Device Detected".
3. Remove the cap from the Visum/StrykeCAM Camera driver dongle (see
Figure 3).
Figure 3: Removing the cap from the StrykeCAM Overhead Camera driver dongle

6
4. Insert the dongle into the device-driver dongle port on the front Sidne™
panel (see Figure 4).
Figure 4: Inserting the dongle into Sidne™
5. Follow the voice instructions given by Sidne™. To avoid equipment
damage, please do not remove the dongle card before Sidne™ says,
“Please remove card.”
6. Wait for the installation to complete. Unlike other upgrades, Sidne™ will
power off after the installation. Once Sidne™ powers-off, turn Sidne ON.
When the console says, “Sidne™ ready,” the driver is installed and ready
for use.
Caution Sidne™ should say “O. R. Lights” and “Overhead Camera
Connected” and the EDAM LED should be steady amber within
60 seconds of powering On the Visum Power box. A different
LED output may indicate device problems. Refer to the
“Troubleshooting Guide” of this addendum for instructions, in
that case.
When Sidne™ says this... Do this...
“Software card detected. Please stand by.” Wait for the next instruction. Do not remove the
dongle until Sidne™ says, “Please remove card.” Wait
for the next instruction.™
“Programming failed.”a
aSidne™ will announce this message only if the programming has
failed.
Sidne™ will announce this message only if the
programming has failed. Remove the dongle, restart
Sidne and reinsert the dongle. If the same problem
occurs again, contact Stryker Technical Support.
“Programming complete.” Wait for the next instruction.
“Please remove card.” Remove the driver dongle from the Sidne™ console.
Wait for Sidne™ to power off before powering Sidne™
back on again.

7
Operating the Visum O. R. Lights
Tablet Commands
WARNING An upgraded SIDNE Ready StrykeCAM Camera is required
for all functionality. Camera control will be disabled
without the Camera.
Figure 5: The Sidne™ tablet commands menu for the Visum O. R. Lights
The following table describes the Tablet buttons, level meters, and their functions.
Button Group Buttons/Levels Description
Light specific
controls
Power button Turn On/Off a particular light. The button also
shows the state of that light; green denotes that
the light is ON while blue denotes that the light
is OFF.
Brightness level This level meter shows the current intensity of a
particular light. The range is from 1 through 7.
High button Sets a particular light to the maximum intensity.
Low button Sets a particular light to the minimum intensity.
Brighter button Increases the intensity of a particular light by
one unit. If this button has a gray background,
then the light is already at the maximum
intensity.
Darker button Decreases the intensity of a particular light by
one unit. If this button has a gray background,
then the light is already at the minimum
intensity.
POWER BUTTON BRIGHTNESS
LEVEL BRIGHTNESS
CONTROLS

8
Voice Commands Menu
Figure 6: The voice commands interface on the monitor
The following table describes the Sidne™ voice commands for controlling the
StrykeCAM Overhead Camera.
All Light
controls
On button Turn On all the lights.
Off button Turn Off all the lights.
High button Sets all lights to the maximum intensity.
Low button Sets all lights to the minimum intensity.
Brighter button Increases the intensity of all lights by one unit, if
possible.
Darker button Decreases the intensity of all lights by one unit,
if possible.
Top Level Device
Selection Function Selection Description
Sidne O.R. Lights Light 1 or
Light 2 or
Light 3 or
Light 4
Brighter Increment light intensity by one unit
Darker Decrement light intensity by one unit
High Set light intensity to maximum
Low Set light intensity to minimum
On Turn light ON
Off Turn light OFF
All lights Brighter Increment light intensity of all connected lights by
one unit, if possible
Darker Decrement light intensity of all connected lights by
one unit, if possible
High Set light intensity of all connected lights to
maximum
Low Set light intensity of all connected lights to
minimum
On Turn all connected lights ON
Off Turn all connected lights OFF
Button Group Buttons/Levels Description

9
Sidne™ Feedback Messages
The following table shows Sidne™ feedback messages and their meanings.
Notes on operation on SIDNE-Visum Lights Interface
1. When any light is at maximum intensity, the “High” and the “Brighter”
commands are not available and they will be shown in gray to indicate
this condition.
2. When any light is at minimum intensity, the “Low” and the “Darker”
commands are not available and they will be shown in gray to indicate
this condition.
3. When any light is ON, the “Off ” command is not available it will be
shown in gray to indicate this condition.
4. When any light is OFF, the “On” command is not available and it will be
shown in gray to indicate this condition.
Voice Message Playback Condition
Connected Visum O.R. Lights are turned on and plugged into Sidne
Disconnected Visum O.R. Lights were plugged into Sidne and now have been disconnected or
turned off
Light Error An error has been reported on one or more of the connected Visum O.R.
Lights.
Servicing may be necessary.
O.R. Lights... Added as a prefix to the above messages, when feedback message is announced
while not in the O.R. Lights Voice Command menu. Also added as a prefix to
the “Connected” and “Disconnected” message.

10
Operating the StrykeCAM
Overhead Camera
Tablet Commands
Figure 7: The Sidne™ tablet commands menu for the StrykeCAM Overhead Camera
The following table describes the tablet commands and their functions.
Button Group Buttons/Levels Description
Iris Automatic Sets the camera to automatic Iris control. If this button is
Orange, this also indicates that the camera is set to automatic
Iris control.
Manual Sets the camera to manual Iris control. If this button is
Orange, this also indicates that the camera is set to manual Iris
control.
Brighter button Increase the Iris by one unit. If this button has a gray
background, then the camera is already at the maximum Iris.
Using this button will set the camera to manual Iris mode.
Darker button Decrease the Iris by one unit. If this button has a gray
background, then the camera is already at the minimum Iris.
Using this button will set the camera to manual Iris mode.

11
Voice Commands Menu
Figure 8: The voice commands interface on the monitor
Focus Automatic Sets the camera to automatic focus control. If this button is
Orange, this also indicates that the camera is set to automatic
focus control.
Manual Sets the camera to manual focus control. If this button is
Orange, this also indicates that the camera is set to manual
focus control.
Out button Starts to focus out of the current view. Releasing the button
will stop the focus out. If this button has a gray background,
then the camera is already at the maximum focus. Using this
button will set the camera to manual focus mode.
In button Starts to focus into current view. Releasing the button will stop
the focus in. If this button has a gray background, then the
camera is already at the minimum focus. Using this button
will set the camera to manual focus mode.
Zoom Controls Zoom Out button Starts to zoom out to a wide-angle view. Releasing the button
will stop the zoom. If this button has a gray background, then
the camera is already at the minimum Zoom.
Zoom In button Starts to zoom into a tele-photo view. Releasing the button will
stop the zoom. If this button has a gray background, then the
camera is already at the maximum Zoom.
White Balance
Controls
White Balance Button White-balances the camera. If this button has a gray
background, the camera has already been white balanced.
Button Group Buttons/Levels Description

12
The following table shows the Sidne™ voice commands for controlling the
StrykeCAM Overhead Camera.
Sidne™ Feedback Messages
The following shows the Sidne™ feedback messages and their meanings.
Notes on the Operation of the SIDNE-StrykeCAM Overhead
Camera Interface
1. While the camera is executing any of the following commands initiated
by the SIDNE Interface - Zoom In, Zoom Out, Focus In, Focus Out - all
commands on the tablet interface and all commands on the voice
interface except "Stop" will be disabled. The camera will not respond to
new commands at this point. When the user says "Stop", or releases the
button on the tablet, all commands on the voice and tablet interfaces will
be enabled. Alternatively, if the camera reaches the minimum or
maximum values of Zoom or Focus, respectively, the commands get
enabled.
2. The StrykeCAM Overhead Camera takes approximately 3 seconds to
complete the WhiteBalance command. During this period, all
commands on the tablet interface and all commands on the voice
interface. When the camera completes the WhiteBalance action, all
commands on the voice and tablet interfaces will be enabled. Please do
not attempt to issue any other commands to the camera while it is
completing the WhiteBalance action.
Top Level Device
Selection Function Selection Description
Sidne Overhead
Camera
White Balance Initiate White Balance
Zoom Out Zoom out continuously
Zoom in continuously
Zoom In
Iris Automatic Set Iris/shutter to automatically control brightness
Manual Turn off automatic control of brightness
Brighter Increment light level
Darker Decrement light level
Focus Automatic Set Camera to automatic focus mode
Manual Turn off automatic focus mode
In Focus Camera in
Out Focus Camera out
Voice Message Playback Condition
Connected StrykeCAM Overhead Camera is turned on and plugged into Sidne
Disconnected StrykeCAM Overhead Camera is plugged into Sidne and then disconnected or
turned off
White Balance Complete The StrykeCAM Overhead Camera has completed a white balance
Overhead Camera... Added as a prefix to the above messages, when a feedback message is
announced while not in the Overhead Camera Voice Command menu. Also
added as a prefix to the “Connected” and “Disconnected” messages.

13
3. Please note that there is no indication on the SIDNE Interface (Voice
and Tablet) regarding the maximum and minimum limits on the
following commands:
•Brightness/Darkness
•FocusOut/In
•ZoomIn/Out
The only indication when these quantities have reached their limits will be when
the appropriate buttons/commands are grayed out.
Troubleshooting
Problem Possible Solution
No access to device
through Sidne™
• This problem has several possible causes.
Please see solutions for each problem:
EDAM LED is OFF* • The device is not communicating properly
with the EDAM. Ensure that the device is
properly connected to the EDAM. See the
“Connecting the Visum Power Box” section
of this addendum for more details. Attempt
the following solutions in order:
1. Power off the device.
2. Ensure that device adapter cable is
plugged into the EDAM.
3. Ensure that the device adapter cable is
plugged into the Visum Power box
control box.
4. Power on the device.
5. Ensure that the Visum wall panel
controls do not show any error. If they
do, then contact Technical Support.

14
* The EDAM LED should flash green when the system is function-
ing normally.
ElectroMagnetic Compatibility
Like other electrical medical accessories, the Visum Surgical Lights and
StrykeCAM Overhead Camera require special precautions to ensure
electromagnetic compatibility with other electrical medical devices. To ensure
electromagnetic compatibility (EMC), the Visum Surgical Lights and StrykeCAM
Overhead Camera must be installed and operated according to the EMC
information provided in this manual.
WARNING Do not use cables or accessories other than those provided
with the Visum Surgical Lights and StrykeCAM Overhead
Camera, as this may result in increased electromagnetic
emissions or decreased immunity to such emissions.
WARNING If the Visum Surgical Lights and StrykeCAM Overhead
Camera is used adjacent to or stacked with other equipment,
observe and verify normal operation of the Visum Surgical
Lights and StrykeCAM Overhead Camera in the
configuration it will be used in prior to using it in a surgical
EDAM LED is flashing
amber*
• Sidne™ is not communicating properly with
the Sidne™ device EDAM. See the “Con-
necting the Visum Power Box” section of
this addendum for more details. Attempt
the following fixes in order:
1. Power off the EDAM.
2. Ensure Sidne™ is powered On.
3. Ensure that the Sidne™ interface cable is
plugged into the EDAM.
4. Ensure that the Sidne™ interface cable is
plugged into Sidne™.
5. Power on the EDAM.
Sidne™ says "O. R. Lights
Disconnected" or
"Overhead Camera
Disconnected"
• Power off device.
• Ensure that the device is properly connected
to Sidne™. See the “Connecting the Visum
Power Box” section of this addendum for
further instructions.
• Power on device.
Problem Possible Solution

15
procedure. Consult the tables below for guidance in positioning
the Visum Surgical Lights and StrykeCAM Overhead
Camera.
Caution Portable and mobile RF communications equipment may affect
the normal function of the Visum Surgical Lights and
StrykeCAM Overhead Camera.
Note The Visum Surgical Lights and StrykeCAM Overhead Camera have
been designed and tested to comply with IEC 60601-1-2:2001
requirements for EMC with other devices.
Guidance and Manufacturer's Declaration: Electromagnetic Emissions
Visum Surgical Lights and StrykeCAM Overhead Camera is intended for use in the electromagnetic
environment specified below. The customer or the user of Visum Surgical Lights and StrykeCAM Overhead
Camera should ensure that it is used in such an environment.
Emissions test Compliance Electromagnetic Environment - guidance
RF emissions
CISPR 11
Group 1 Visum Surgical Lights and StrykeCAM Overhead Camera
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 B Visum Surgical Lights and StrykeCAM Overhead Camera
are suitable for use in all establishments, including domestic
establishments and those directly connected to the public
low-voltage power supply network that supplies buildings
used for domestic purposes.
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
Visum Surgical Lights and StrykeCAM Overhead Camera are intended for use in the electromagnetic
environment specified below. The customer or the user of Visum Surgical Lights and StrykeCAM Overhead
Camera should ensure that it is used in such an environment.
Immunity Test IEC 60601 Test
Level
Compliance
Level Electromagnetic Environment: Guidance
Electrostatic
Discharge (ESD)
IEC61000-4-2
±6kV contact
±8kV air
±2,4,6kV
contact
±2,4,8kV 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
IEC61000-4-4
±2kV for power
supply lines
±1kV for input/
output lines
±2kV for
power supply
lines (Sidne)
±1kV for
input/output
lines
Mains power quality should be that of a
typical commercial or hospital environment.
Power frequency (50/
60Hz) magnetic field
IEC 61000-4-8
3 A/m
3 A/m
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.

16
Portable and mobile RF communications
equipment should be used no closer to any
part of the Visum Surgical Lights and
StrykeCAM Overhead Camera system,
including its cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of the
transmitter.
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80
MHz
3 V
Recommended Separation Distance
Radiated RF
IEC 61000-4-3
3 V/m
80MHz to 2.5
GHz
3 V/m 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 meters (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 pagation is affected by absorption
and reflection from structures, objects, and people.
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM 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 Visum Surgical Lights
and StrykeCAM Overhead Camera system is used exceeds the applicable RF compliance level above, the Visum
Surgical Lights and StrykeCAM Overhead Camera system should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the
Visum Surgical Lights and StrykeCAM Overhead Camera unit.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
Visum Surgical Lights and StrykeCAM Overhead Camera are intended for use in the electromagnetic
environment specified below. The customer or the user of Visum Surgical Lights and StrykeCAM Overhead
Camera should ensure that it is used in such an environment.
d1.17P=
d1.17P=
d2.33P=