BCM Advanced Research 69229100 Industrial System with Wi-Fi User Manual
BCM Advanced Research Inc Industrial System with Wi-Fi
Users Manual
SEDASYS® Connectivity Unit Operator’s Manual
(Document Number: EES0000700)
DRAFT
This page is intentionally left blank.
DRAFT
iii
COPYRIGHT INFORMATION
All rights are reserved. No one is permitted to reproduce or duplicate, in
any form, the whole or part of this manual, without permission from
Ethicon Endo-Surgery, Inc.
PRODUCT INFORMATION
MANUFACTURED BY:
ETHICON ENDO-SURGERY, INC.
4545 Creek Road
Cincinnati,Ohio 45242-2839 USA
OWNERSHIP
The SCU is the property of Ethicon Endo-Surgery, Inc., and is placed in
the facility in accordance with the contractual arrangement between
Ethicon Endo-Surgery and the facility.
COMPLIANCE AND CERTIFICATE
CE Declaration:
CE marking is a visible declaration by the manufacturer or his authorized
representatives that the electrical equipment to which it relates satisfies
all the provisions of the 1994 Regulations.
FCC Compliance:
This device complies with Part 15 of the FCC Rules. Operation of the
device is subject to the following two conditions:
• This device may not cause harmful interference.
• This device must accept any interference that may cause undesired
operation.
This equipment generates uses and can radiate radio frequency energy
and, if not installed and used in accordance with the instructions, may
cause interference to radio communications. This equipment has been
tested and found to comply with the limits for a Class B digital device,
pursuant to Part 15 of the FCC Rules. These limits are designed to
Product Code Product
SEDSCU01 SEDASYS Connectivity Unit (SCU)
External Standard Conformance TBD
DRAFT
iv
provide reasonable protection against harmful interference. However,
there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment
off and on, the user is encouraged to try to correct the interference by one
or more of the following measures:
• Reorient or relocate the antenna of the radio/television receiver.
• Increase the separation between this equipment and the radio/
television receiver.
• Plug the equipment into a different outlet so that the equipment and
the radio/television receiver are on different power mains branch
circuits.
• Consult a representative of EES or an experienced radio/television
technician for additional suggestions.
Note
Changes or modification not expressly approved by EES for compliance could
void the user’s authority to operate the equipment.
DRAFT
v
SERVICE AND SUPPORT INFORMATION
Within the USA contact:
EES Customer Support Center, 1-800-SEDASYS, 1-800-733-2797
(English speaking only)
Outside of USA contact:
Local Johnson & Johnson Affiliate office or closest Authorized
Service Center
Authorized Service Centers locations:
USA
Ethicon Endo-Surgery, Inc.
4480 Lake Forest Drive Suite 318
Cincinnati, OH 45242
1-800-SEDASYS (U.S.), 1-800-733-2797
Phone: 1-513-337-8901 (International calls - English speaking only)
Email: sedasystechsupport@its.jnj.com
WARNING
CMOS Battery Damage
Replace system’s CMOS RAM battery only with the identical CR-2032 3V
Lithium-ion coin cell (or equivalent) battery type to avoid risk of personal injury
or physical damage to the equipment. Improper installation might cause battery
to explode. Always dispose of used batteries according to the manufacturer’s
instructions, or as required by the local ordinance (where applicable).
Perchlorate Material – Special Handling May Apply.
See http://www.dtsc.ca.gov/hazardouswaste/perchlorate/
DRAFT
vi
This page is intentionally left blank.
DRAFT
vii
DOCUMENT CONVENTIONS
The following conventions are used throughout this manual:
Intended Use: Refers to the objective intent of the persons legally
responsible for the labeling of the device.
WARNING
Describes serious adverse reactions and potential safety hazards, limitations in
use imposed by them, and steps that should be taken if they occur. Warnings
alert the clinician to the possibility of serious injury, death, or other serious
adverse reactions associated with the use or misuse of the system.
Precaution
Pertains to information regarding any special care to be exercised by the
practitioner and/or patient for the safe and effective use of the device.
Precautions alert the clinician to the possibility of minor or moderate injury to
the clinician or patient, or damage to the device associated with the use or
misuse of the system.
Note
Notes emphasize important details.
DRAFT
viii
SYMBOLS
The following symbols will be physically located on one or more
components of the system.
Symbol Description
NOT COMPLETE –
TBD NOT COMPLETE – TBD
DRAFT
ix
Contents
Chapter 1: Introduction ............................................................................................. 1 - 1
SCU Overview .................................................................................... 1 - 1
Chapter 2: Intended Use, Warnings and Precautions ............................................ 2 - 1
Warnings ............................................................................................ 2 - 2
Precautions ........................................................................................ 2 - 3
Notes .................................................................................................. 2 - 4
Appendix A: Technical Information ........................................................................A - 1
DRAFT
Contents
x
This page is intentionally left blank.
DRAFT
1 - 1
Chapter 1 Introduction
SCU Overview
The SEDASYS® Connectivity Unit (SCU) is a communications interface
device for use with the SEDASYS® System. The SCU automatically
collects data from the SEDASYS® System that is required for usage
billing, and transmits that information via the facility’s IT network to
Ethicon Endo-Surgery for processing and preparing an invoice for the
facility.
The SEDASYS® System transmits the data, in an encrypted form, to the
SCU. This communication is wireless and complies with IEEE 802.11-
2007. The data is delivered to the SCU only when the SEDASYS®
System detects communication with the SCU. The SCU then transmits
the encrypted data through the facility’s IT network to Ethicon Endo-
Surgery. This communication can be wireless (IEEE 802.11-2007) or
wired (IEEE 802.3). For either wireless or wired communication, the
facility’s IT network configuration should allow outbound communication
to the internet with ports 80 and 443 open.
The encrypted data is typically a packet of TBD size delivered in 15
minute intervals. Data transferred will contain the case related data
including identification of the hardware unit, case identification, and
patient identification number. The clinician is instructed, in the
SEDASYS® System manual, not to use a patient identifier (such as Social
Security number or phone number) that is traceable to the patient outside
of the clinical facility records.
The SCU can also deliver a printout, containing usage details, to the
printer used in conjunction with the SEDASYS® System.
DRAFT
Chapter 1 Introduction
1 - 2
This page is intentionally left blank.
DRAFT
2 - 1
Chapter 2 Intended Use, Warnings and
Precautions
The SEDASYS® Connectivity Unit (SCU) is intended only for use with the
SEDASYS® System for the purpose of collecting and transferring usage
data. Applying the SCU for use in another application, or modifying or
tampering with the SCU, may affect the business agreement with Ethicon
Endo-Surgery.
If it should become necessary to re-position after the initial installation, the
following orientation information is provided.
Figure 2-1 represents placement of the SCU on a flat surface and
oriented with the front of the SCU facing the installer. Placement of the
SCU shall be located a minimum of 1.5 meters (approximately five feet)
from patients. Figure 2-1 represents an approved and the preferred
placement orientation.
Figure 2-2 represents placement of the SCU on a flat surface and
oriented with the front of the SCU facing down. This is not a stable
orientation, and can only be used when the SCU is secured to prevent
falling or tipping. Placement of the SCU shall be located a minimum of 1.5
meters (approximately five feet) from patients. Figure 2-2 represents an
approved placement orientation but not preferred.
Figure 2-1 Approved and Preferred Orientation
Figure 2-2 Approved Orientation
DRAFT
Chapter 2 Intended Use, Warnings and Precautions
2 - 2
Warnings
The following WARNINGS alert the user to the possibility of serious injury,
death, or other serious adverse events associated with the use or misuse
of the SEDASYS® System.
WARNING
1 Do not place items on, or hang items from, the SCU. Doing so may result in
a physical and/or electrical hazard.
2 Do not modify the installation (electrical or mounting) of the system. The
SCU must be kept outside the “patient environment” to maintain electrical
safety. The patient environment is defined as an area 1.5 m (4.92 feet)
from the patient.
3 Do not store or place liquids on or near the SCU. Entry of liquids into the
SCU may result in electric shock.
4 To help protect against electrical shock due to leakage current, use only
power accessories (power cord, adaptor) supplied with the SCU.
5 In order to comply with FCC RF exposure limits, the antenna should be
located at a minimum distance of 20 cm (8 inches) or more from the body
of all persons.
6 Due to fire safety reasons the SCU must not be oriented in the positions
shown below :
The above figure represents placement of the SCU on a flat surface and
orientated with the back of the SCU facing down. This orientation represents an
unstable condition and is not an approved placement orientation.
DRAFT
Chapter 2 Intended Use, Warnings and Precautions
2 - 3
Precautions
The following PRECAUTIONS alert the user to the possibility of minor or
moderate injury or damage to the device associated with the use or
misuse of the SCU.
WARNING
The above figure represents placement of the SCU on a flat surface and
orientated with the side of the SCU facing down. This represents a placement
orientation that is not approved.
The above figure represents placement of the SCU on a flat surface and
orientated with the top of the SCU facing down. This represents a placement
orientation that is not approved.
Precaution
1 To remove the device from external power, the power cable must be
disconnected from wall outlet.
2 The system may not meet performance requirements if operated outside
the specified temperature and humidity ranges.
3 Electronic equipment, such as portable and mobile RF communications
equipment, can cause electrical interference with the system. Avoid
operating the system near equipment that emits strong electromagnetic or
radio frequency signals.
4 Do not place a covering or otherwise interfere with the ventilation of the
SCU. Doing so may result in overheating.
DRAFT
Chapter 2 Intended Use, Warnings and Precautions
2 - 4
Notes
The following NOTES provide important information.
Note
1 Placement of additional walls or structure between the SCU and
SEDASYS® System or the SCU and IT network (if wireless), after
installation, may interfere with the transfer of data.
2 Do not disconnect the SCU from power or the IT network.
3 Contact EES prior to changes to either the network configuration
(hardware or setting) or the printer configuration.
4 Contact EES if SCU power indication is not “ON”.
5 Contact EES if usage detail printout are not being printed as expected.
6 SCU is intended for use only with the SEDASYS® System.
7 The SCU and its supplied parts (for example the power cord and antenna)
are to be handled carefully.
8 Only those parts supplied with the SCU are to be used in conjunction with
the SCU.
9 Replacement parts are to be obtained only from EES.
10 Contact EES for instructions regarding the proper disposal of the SCU.
DRAFT
A - 1
Appendix A Technical Information
TBD-specifics to be confirmed
Table A-1: Power Specifications
Characteristic Performance
Input line voltage 100 to 240 volts AC
Input line frequency 50 to 60 Hz
Phase Single
Table A-2: Environmental Specifications
Characteristic Performance
Operating temperature 10 to 40 C (50 to 104 F)
Relative humidity 30% to 75%, noncondensing
Operating altitude 0 to 10,000 feet
Transport and storage temperature 0 to 60 C (32 to 104 F)
Table A-3: Electromagnetic Emissions
Characteristic Compliance Electromagnetic Environment
- Guidance
RF Emissions CISPR 22 Class B, FCC The SCU is suitable for use in
domestic environments.
RF Emissions VCCI Class B, Japan
RF Emissions (Digital Apparatus) ICES-003 Class B, Canada
Table A-4: Electromagnetic Immunity
Characteristic Compliance
RF Immunity CISPR 24 (EN55024)
Electromagnetic Magnetic Compatibility Directive 2004/108/EC
DRAFT
Appendix A Technical Information
A - 2
Table A-5: Facility Communications Requirements
Characteristic Performance
Wireless format IEEE 802.11 b/g
Wired format IEEE 802.3 (100BASE-T Ethernet)
Wireless encryption protocol WEP-40 or WEP-104 or CCMP or TKIP
Wireless key structure ((Alpha, hexadecimal, alphanumeric, case
sensitivity))
Wireless SSID ((Broadcast/not broadcasted))
Wired encryption protocol WPA-PSK or WPA2-PSK AES
Table A-6: Electrical Safety Specifications
Characteristic Compliance
Electrical Safety Standards
IEC 60950-1
EN 60950-1
UL 60950-1
CAN/CSA-C22.2 No. 60950-1
AS/NZS 60950-1
AS/NZS 60950-1Amt1
AS/NZS 60950-1Amt2
AS/NZS 60950-1Amt3
Low Voltage Directive 2006/95/EC2
Table A-7: Data Packet Information
Characteristic Performance
Data packet size – typical
Data transmission frequency - default
Table A-8: Hazardous Material Information
Characteristic Compliance
Restrictions on Hazardous Substances RoHS Directive 2002/95/EC
Waste Equipment WEEE 2002/96/EC
DRAFT
Appendix A Technical Information
A - 3
Table A-9: Telecommunications Information
Characteristic Compliance
Radio Communication Devices RSS-210: 2007
Exposure to RF RSS-102: 2005
Radio Communication FCC CFR Title 47, Part 15 Class B
Radio Communication R&TTE Directive 1999/5/EC
Radio Communication EN 300 328 V1.7.1
Radio Communication EN 301 893 V1.4.1
Radio Communication EN 301 489-1 V1.8.1
Radio Communication EN 301 489-17 V1.3.2
Radio Communication AS/NZS 4771:2000
DRAFT
Appendix A Technical Information
A - 4
This page is intentionally left blank.
DRAFT