RX only stryker User manual

User Guide
SIDNE®Berchtold®
Chromophare®E-Series
Lighting Package
REF 240-020-838

EN-1
SIDNE®Berchtold®
Chromophare®E-Series
Lighting Package
User Guide
Contents
Warnings and Cautions ............................................................. 2
Product Description .................................................................... 3
Intended Use ..................................................................................... 3
Package Contents ............................................................................ 3
Setup and Interconnection ..................................................... 4
Determining the Connections between SIDNE and the Berchtold
Lights Control Box ................................................................................... 4
Connecting the Berchtold® Lights System and SIDNE® ................. 4
Mounting the EDAM .......................................................................... 5
Installing the Berchtold Lights Driver Upgrade ................................. 5
System Operation ......................................................................... 7
Accessing the Surgical Light Controls from SIDNE .......................... 7
Touchscreen Commands .................................................................. 8
Voice Commands ........................................................................... 10
Notes on the SIDNE® Berchtold Surgical Lights Interface ............ 11
Troubleshooting Guide ............................................................ 12
Electromagnetic Compatibility .......................................... 13

EN-2
Warnings and Cautions
Please read this manual and follow its instructions carefully. The words warning,
caution, and note carry special meanings and should be carefully reviewed:
Warning Warning indicate risks to the safety of the patient or user.
Failure to follow warnings may result in injury to the patient or
user.
Caution Caution indicate risks to the equipment. Failure to follow
cautions may result in product damage.
Note Notes provide special information to clarify instructions or
present additional useful information.
An exclamation mark within a triangle is intended to alert the
user to the presence of important operating and maintenance
instructions in the manual.
A lightning bolt within a triangle is intended to warn of the
presence of hazardous voltage. Refer all service to authorized
personnel.
Warning To avoid potential serious injury to the user and the patient
and/or damage to this device, please note the following
warnings:
1. Read this manual thoroughly and be familiar with its contents prior to
using this equipment.
2. The Berchtold® Chromophare E-Series Surgical Lighting System and the
SIDNE® Berchtold® Chromophare Surgical Lighting EDAM are designed
to be used by a qualified physician or technician familiar with their use.
3. Carefully unpack the package and check if any damage occurred during
shipment. If damage is detected, DO NOT use the equipment.
4. Do not immerse the SIDNE Berchtold Chromophare Surgical Lighting
EDAM or allow fluid to enter the chassis or connector.
5. Before and after each use, inspect the cord insulation for cracks, nicks,
cuts, dents, or depressions. Any irregularity will decrease the
effectiveness of the insulation and may result in shocks to the patient
and/or operating room personnel.
6. Always power off the Berchtold Chromophare E-Series Surgical Lighting
System Control Center or refer to the Berchtold® User Manual when
connecting or disconnecting accessories.

EN-3
Product Description/Intended Use
The SIDNE® Berchtold® Chromophare E-Series Surgical Lighting package
(the Berchtold Lights package) is a hardware/software interface between the
SIDNE voice-activation system and the Berchtold Chromophare E-Series Surgical
Lighting system (the Berchtold Lights system). This interface provides voice-
activated or touchscreen control of the Berchtold Lights system.
Indications/Contraindications
The SIDNE Berchtold Camera or Light drivers are intended for use in voice
activation and control of attached voice compatible devices. It is indicated for use
in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic
surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. The
users of such a device are general surgeons, gynecologists, cardiac surgeons,
thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, and
urologists.
There are no known contraindications.
Package Contents
The Berchtold Lights package includes the following components.
1. SIDNE Berchtold Chromophare E-Series Surgical Lights External
Device Adapter Module (EDAM)
2. Velcro strips for mounting the EDAM
3. 30-foot device adapter cable
4. Berchtold Lights driver upgrade
5. 6-foot USB cable (SIDNE interface cable)
12
5
4
3

EN-4
Setup and Interconnection
Below is a block diagram of the necessary connections between SIDNE® and the
Berchtold® Lights Control Center.
Determining the Connections between SIDNE and
the Berchtold Lights Control Box
A qualified installation professional can connect the device adapter cable to the
internal USB type B connector of the Berchtold Lights Control Box. Consult the
Berchtold Chromophare E-Series Surgical Lights manual.
Check the Berchtold lights control box to ensure that the correct port for the
device adapter cable is present. The port should be a USB type B female port
which accepts the USB type B male end of the device adapter cable.
Connecting the Berchtold® Lights System and
SIDNE®
1. Power off the Berchtold Lights Control Box and the SIDNE console.
2. Connect the device adapter cable from the Berchtold Lights control box
to the DB-9 connector of the EDAM (see below).
3. Connect the SIDNE interface cable to the USB port of the EDAM
(see below).
EDAM
SIDNE 1234
1 = USB Type A
2 = USB Type B
3 = Female DB-9
4 = USB Type B
Berchtold
Lights
System
Device Adapter
SIDNE Interface
Cable

EN-5
4. Connect the other end of the SIDNE interface cable to one of the eight
USB ports on the SIDNE console (see below).
The SIDNE console is now connected to the Berchtold Lights System.
Mounting the EDAM
Stryker recommends securing the EDAM in a secure location on a cart.
1. Remove the Velcro strips from the package.
2. Carefully remove the protective paper backing covering the adhesive
side of the Velcro strips.
3. Attach one velcro strip to the bottom of the EDAM and the other velcro
strip to the desired mounting location, as shown below.
4. Align the velcro strips and press down on the EDAM.
Installing the Berchtold Lights Driver Upgrade
The Berchtold® Lights Driver Version 1.0 allows the SIDNE® console to
communicate with the Berchtold Lights System.
Note Do not attempt to install any other software driver until the
Berchtold Lights Driver 1.0 is installed and the SIDNE console
has been restarted and says “SIDNE ready” (after step 5 of this
section).
1. Power on the Berchtold Lights Control Box.

EN-6
2. Power on the SIDNE console and wait until SIDNE says “SIDNE ready.”
If the Berchtold Lights Control Box is on, SIDNE will announce
“Unknown device detected.”
3. Insert the dongle into the device-driver dongle port on the front SIDNE
panel.
4. Follow the voice instructions given by SIDNE. To avoid equipment
damage, do not remove the dongle card until SIDNE says, “Please
remove card.”
5. Power SIDNE on. When the console says, “SIDNE ready,” the driver is
installed and ready for use.
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.”
“Software installation
started. Please wait.”
Wait for the next instruction.
“Programming started.”
“10% complete, 20%
complete…”
Wait for the next instruction.
“Programming failed.” SIDNE® will announce this message only if the
programming has failed. If this occurs, follow
the steps below:
1. Remove the dongle, restart SIDNE, and
reinsert the dongle.
2. If the same problem occurs again, contact
Stryker Technical Support.
“Programming complete.
Please wait”
Wait for the next instruction.
“Software installation
complete.”
Wait for the next instruction.
“Please remove card.” Remove the driver dongle from the SIDNE
console. Wait for SIDNE to power off.

EN-7
Caution SIDNE should say “O. R. Lights Connected” and the EDAM
LED should flash green within 30 seconds after the Berchtold®
Lights Control Box and SIDNE have been powered on and
initialized. A different LED output may indicate device
problems. If this occurs, refer to the “Troubleshooting Guide”
of this manual for instructions.
System Operation
Accessing the Surgical Light Controls from SIDNE
The controls for the Berchtold® Surgical Lights are all grouped within the “O. R.
Lights” option on the SIDNE® menus. To access the controls, select “O. R. Lights”
from the main menu, either through the touchscreen or by voice command,
as shown below.

EN-8
Touchscreen Commands
The figure below shows the touchscreen controls for the Surgical Lights.
The following table describes touchscreen buttons, level meters, and functions.
Button
Group
Buttons/
Levels Description
1
Light-
specific
controls
Power Turns a particular light on or off. The button also
shows the state of that light; green indicates that the
light is on, while blue indicates that the light is off.
Brightness
level
Shows the current intensity of a particular light.
The levels range from 1 through 8.
High Sets a particular light to the maximum intensity.
If this button has a gray background, then the light
is already at the maximum intensity.
Low Sets a particular light to the minimum intensity.
If this button has a gray background, then the light
is already at the minimum intensity.
+ 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.
- Decreases the intensity of a particular light by one
level. If this button has a gray background, then the
light is already at the minimum intensity.
12
3

EN-9
2
All Light
controls
On Turns all the lights on.
Off Turns all the lights off.
High Sets all lights to the maximum intensity.
Low Sets all lights to the minimum intensity.
Brighter Increases the intensity of all lights by one level,
if possible.
Darker Decreases the intensity of all lights by one level,
if possible.
3
Endo-
Lite®
Controls
On Turns the EndoLite® On.
Off Turns the EndoLite® Off.

EN-10
Voice Commands
(For voice-enabled SIDNE® models only.)
The table below shows the SIDNE voice commands for controlling the Berchtold
Surgical Lights.
Top
Level
Device
Selection Function Selection Description
SIDNE O. R.
Lights
Light 1 or
Light 2 or
Light 3
Activate Turns light on.
Brighter Increases light intensity by
one level.
Darker Decreases light intensity by
one level.
High Sets light intensity to
maximum level.
Low Sets light intensity to
minimum level.
Off Turns light off.
All Lights Activate Turns all connected lights
ON.
Brighter Increases light intensity of
all connected lights by one
level, if possible.
Darker Decreases light intensity of
all connected lights by one
level, if possible.
High Sets light intensity of all
connected lights to
maximum level.
Low Sets light intensity of all
connected lights to
minimum level.
Off Turns all connected lights
off.
EndoLite Activate Turns on the EndoLite
Off Turns off the EndoLite

EN-11
Status Bar
The status bar, shown below, appears at the bottom of the monitor screen and
indicates the light level for Lights 1 through 3 (marked “L1,” “L2,” and “L3,”
respectively).
1. Indicates light 1 level
2. Indicates light 2 level
3. Indicates light 3 level
4. Indicates if Endolite is on or off
SIDNE Feedback Messages
The table below shows the feedback messages for the surgical lights.
Notes on the SIDNE® Berchtold Surgical Lights
Interface
1. When any light is at maximum intensity, the “High” and the “Brighter”
commands are not available. They will be shown in white to indicate this
condition.
2. When any light is at minimum intensity, the “Low” and the “Darker”
commands are not available. They will be shown in white to indicate this
condition.
3. When any light is on, the “On” command is not available. It will be
shown in white to indicate this condition.
4. When any light is off, the commands “Darker,” “Low,” “Brighter,” “High,”
and “Off ” will be shown in white to indicate that these commands are
not available. Use the “Activate” command to activate any light.
5. The EndoLite can only be controlled when the light is activated.
Activating the EndoLite deactivates the surgical area illumination and
activates the surround lighting.
Voice Message Playback Condition
O. R. Lights … Added as a prefix to a feedback message, when not in the O.
R. Lights Voice Command menu. Also added as a prefix to
the “Connected” and “Disconnected” messages.
4321

EN-12
6. Deactivating the EndoLite will deactivate the surround lighting and
activate the surgical area illumination.
7. Activating the light that the EndoLite is attached to will deactivate the
surround lighting and activate the surgical area illumination.
Troubleshooting Guide
The table below shows the most common errors and possible solutions to each.
Problem Possible Solution
No access to device
through SIDNE®
This problem has several possible causes. Please see below.
EDAM LED continually
flashes red*
Contact Stryker Endoscopy or your local Stryker sales
representative for firmware upgrade.
EDAM LED shines
solid red*
The device is not communicating properly with the EDAM.
Ensure that the device is properly connected to SIDNE.
(See the “Setup and Interconnection” section of this manual
for more details.)
Attempt the following steps in order:
• Power off the device.
• Ensure the device adapter cable is connected to
the Berchtold Lights control box and the
EDAM.
• Power on the device.
EDAM LED shines
solid yellow*
SIDNE is not communicating properly with the EDAM.
See the “Setup and Interconnection” section of this manual
for more details.
Attempt the following steps in order:
• Power off the device.
• Ensure SIDNE is powered on.
• Ensure that the SIDNE interface cable is
connected in to the EDAM.
• Ensure that the SIDNE interface cable is
connected in to SIDNE.
• Power on the device.

EN-13
The audio feedback messages indicate whether the surgical lights are connected.
Electromagnetic Compatibility
Like other electrical medical equipment, the SIDNE Berchtold Lights package
requires special precautions to ensure electromagnetic compatibility with other
electrical medical devices. To ensure electromagnetic compatibility (EMC), the
SIDNE Berchtold Lights package must be installed and operated according to the
EMC information provided in this manual.
Note The SIDNE Berchtold Lights package has been designed and
tested to comply with IEC 60601-1-2:2001 requirements for EMC
with other devices.
Caution This product is considered electronic equipment. It must not
be disposed of as unsorted municipal waste and must be
collected separately. Please contact the manufacturer or other
authorized disposal company to decommission your
equipment.
Caution Equipment which employs RF communications may affect the
normal function of the SIDNE Berchtold Lights package.
Warning Do not use cables or accessories other than those provided
with the SIDNE Berchtold Lights package, as this may result in
increased electromagnetic emissions or decreased immunity
to such emissions.
SIDNE says “O. R.
Lights Disconnected”
• Power off the device.
• Ensure that the device is properly connected to
SIDNE (See the “Setup and Interconnection”
section of this manual for further instructions.)
• Power on the device.
*The EDAM LED should flash green when the system is functioning normally.
Voice Message Playback Condition
Connected Berchtold® Surgical Lights are activated and
connected to SIDNE®.
Disconnected Berchtold Surgical Lights are disconnected or
turned off.
Problem Possible Solution

EN-14
Warning If the SIDNE Berchtold Lights package is used adjacent to,
or stacked with other equipment, observe and verify normal
operation of the SIDNE Berchtold Lights package in the
configuration in which it will be used prior to using it in a
surgical procedure. Consult the tables below for guidance in
placing the SIDNE Berchtold Lights package.
Guidance and Manufacturer's Declaration: Electromagnetic Emissions
SIDNE® Berchtold® Lights package is intended for use in the electromagnetic environment
specified below. The customer or the user of SIDNE Berchtold Lights package
should ensure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment: Guidance
RF emissions CISPR 11 Group 1 SIDNE Berchtold Lights package 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 The SIDNE Berchtold Lights package is
suitable for use in all establishments other
than domestic establishments and those
directly connected to the public low-voltage
power supply network that supplies buildings
used for domestic purposes, provided the
following warning is heeded:
This system is intended for use by health care
professionals only. This system may cause
radio interference or may disrupt the
operation of nearby equipment. It may be
necessary to take mitigation measures, such as
reorienting or relocating the system or
shielding the location.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage Fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
SIDNE Berchtold Lights package is intended for use in the electromagnetic environment
specified below. The customer or the user of SIDNE Berchtold Lights package
should ensure that it is used in such an environment.
Immunity Test IEC 60601
Te st L e v e l
Compliance Level Electromagnetic
Environment:
Guidance

EN-15
Electrostatic Discharge
(ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±2, 4, 6 kV contact
±2, 4, 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
±1 kV for input/
output lines
±2 kV line to
ground
±1kV line to line
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Surge
IEC 61000-4-5
±1 kV differential
mode
±2 kV common mode
±0.5, 1 kV
differential mode
±0.5, 1, 2 kV
common mode
Mains power quality
should be that of a
typical commercial
or hospital
environment.
Voltage dips, shor t
interruptions and
voltage variations
on power supply
input 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 sec.
<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 sec.
Mains power quality
should be that of a
typical commercial
or hospital
environment. If the
user of SIDNE
Berchtold Lights
package requires
continued operation
during power mains
interruptions, it is
recommended that
SIDNE Berchtold
Lights package be
powered from an
uninterruptible
power supply or a
battery.
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
SIDNE Berchtold Lights package is intended for use in the electromagnetic environment
specified below. The customer or the user of SIDNE Berchtold Lights package
should ensure that it is used in such an environment.

EN-16
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m N/A Power-frequency
magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital
environment.
NOTE: Ut is the AC mains voltage prior to application of the test level.
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
SIDNE® Berchtold Lights package is intended for use in the electromagnetic environment
specified below. The customer or the user of SIDNE Berchtold Lights package
should ensure that it is used in such an environment.
Immunity Test IEC 60601
Te st L e v el
Compliance
Level
Electromagnetic Environment:
Guidance
Portable and mobile RF
communications equipment should
be used no closer to any part of the
SIDNE Berchtold Lights package,
including its cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Conducted RF 3 Vrms 3 V Recommended Separation Distance
IEC 61000-4-6 150 kHz to 80 MHz
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
SIDNE Berchtold Lights package is intended for use in the electromagnetic environment
specified below. The customer or the user of SIDNE Berchtold Lights package
should ensure that it is used in such an environment.
d1.17P=

EN-17
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 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)
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 SIDNE Berchtold Lights package is used
exceeds the applicable RF compliance level above, the SIDNE Berchtold Lights package should be
observed to verify normal operation. If abnormal performance is observed, additional measures
may be necessary, such as reorienting or relocating the SIDNE Berchtold Lights package.
(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
SIDNE® Berchtold Lights package is intended for use in the electromagnetic environment
specified below. The customer or the user of SIDNE Berchtold Lights package
should ensure that it is used in such an environment.
d1.17P=
d2.33P=