St Jude Medical 201106 Wi-Box User Manual

Download:
Mirror Download [FCC.gov]
Document ID	1542124
Application ID	uOF6QDMBQD50zcrX0x/N8g==
Document Description	Users Manual
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	63.83kB (797835 bits)
Date Submitted	2011-09-15 00:00:00
Date Available	2011-10-30 00:00:00
Creation Date	2011-06-01 17:16:53
Producing Software	Arbortext Advanced Print Publisher 10.0.1376/W Library
Document Lastmod	0000-00-00 00:00:00
Document Title	Users Manual
Document Creator	Arbortext Publishing Engine R54M090-1056

Wi-Box™
ENGLISH
ENGLISH
1. PRODUCT NAME
Wi-Box™
2. CONTENT
Wi-Box
Wi-Box Xpress Cable
(Ordered separately.)
Wi-Box External Power Supply
(Ordered separately.)
Wi-Box Excitation plug
(Ordered separately.)
3. DESCRIPTION
Wi-Box is used for measurement of pressure from an external connected pressure transducer.
It has an eavesdropping function such that a hemodynamic recording system can be directly connected
to the pressure transducer at the same time as Wi-Box measures the pressure and transmits it on a
specific radio interface.
An isolated interface provides the measured pressure as an analog output signal.
4. INDICATION FOR USE
Wi-Box is indicated to condition and transmit a physiological signal via radiofrequency.
5. GENERAL WARNINGS
Wireless transmitter and RadiAnalyzer™ Xpress pressure output ports are not designed nor intended
for vital signs monitoring.
Modification of this equipment is not allowed.
6. GENERAL PRECAUTIONS
Federal (USA) law restricts distribution and sales of Wi-Box to sale by or on the order of a physician.
Handle Wi-Box in accordance with medical practice and applicable local, state and federal laws and
regulations.
Do not use Wi-Box if it has been subject to damage.
If Wi-Box has been subject to accidental wetting, wipe off and perform leakage current measurement
and functional test.
Software upgrade shall not be performed during a clinical procedure.
7. INSTALLATION
7.1 Normal Operation
NOTE: Wi-Box needs to be installed in a place that ensures adequate radio transmission with receiving
unit.
Radio range is reduced by objects and walls, keep Wi-Box and receiving unit in line of sight wherever
possible.
NOTE: High frequency surgical equipment shall not be used in the close proximity of the device since
this could influence the performance of the device.
a. Mount Wi-Box vertically on or close to the cathlab table using the enclosed mounting details.
The cable connectors shall be facing downward to minimize stress on cabling and connectors and
to protect the unit from ingression of fluids.
NOTE: After mounting, Wi-Box is securely fastened and may be very difficult to remove. If Wi-Box
needs to be repositioned, be careful not to damage Wi-Box by bending.
CAUTION: The used pressure transducer must have excitation
impedance larger than 270 Ω.
CAUTION: All equipment connected to AO OUT must be CF
classified and defibrillation proof. Failure to comply to these
requirements will void the CF classification and defibrillation
protection on AO IN.
CAUTION: The person performing the connections of Wi-Box is
responsible for forming a medical electrical system and the total
system and patient leakage currents thereof.
NOTE: The test below shall be performed when changing type of blood pressure transducer.
b. Connect the AO OUT connector on Wi-Box to a blood pressure channel on the ANSI/AAMI-BP22
compatible hemodynamic recording system using the corresponding St. Jude Medical monitor
cable.
c. Connect the blood pressure transducer to the AO IN using the corresponding St. Jude Medical
adapter cable. For appropriate handling of the external pressure transducer (calibration, removing
possible entrapped air, sterility, time limit before use, warm-up time or volume displacement) refer to
its operating instructions.
NOTE: Transducers marked for single-use may not be reused.
d. Make sure that the blood pressure channel is powered.
e. To verify correct pressure, apply a known pressure on the blood pressure transducer using a blood
pressure simulator.
If the green READY light is lit and the AO pressure is correctly displayed on the hemodynamic
recording system, Wi-Box is ready to use.
If the red NOT READY light is lit or the AO pressure is incorrectly displayed on the hemodynamic
recording system, Wi-Box External Power supply needs to be connected to provide adequate power to
the unit (see Wi-Box External Power Supply below).
If the red NOT READY light is blinking, internal fail has occurred.
Contact your St. Jude Medical representative.
7.2 Wi-Box External Power Supply (for low power hemodynamic recording systems)
CAUTION: The only approved power supply to connect is C12785/
FW7333SM.
CAUTION: The power supply shall be mounted at a location where it
is protected from fluids.
CAUTION: Mains power is disconnected by removing Wi-Box
External Power Supply from the wall socket. Place Wi-Box External
Power Supply such that it easily can be removed from the wall
socket.
a. Connect Wi-Box External Power Supply cable to the PSU connector on Wi-Box.
b. Connect Wi-Box External Power Supply to a free wall socket using the appropriate wall socket
adapter.
The white light on Wi-Box shall now be lit indicating that Wi-Box is powered.
c. To verify correct pressure, apply a known pressure on the blood pressure transducer using a blood
pressure simulator.
If the green READY light is lit and the AO pressure is correctly displayed on the hemodynamic
recording system, Wi-Box is ready to use.
If the red NOT READY light still is lit, an internal error has occurred. Try to reconnect Wi-Box
External Power Supply. If the problem remains contact your St. Jude Medical representative. If the
AO pressure is incorrectly displayed on the hemodynamic recording system, do not use the Wi-Box.
Contact St. Jude Medical representative.
d. If Wi-Box is intended to be used stand-alone without hemodynamic recording system, Wi-Box
Excitation Plug shall be inserted in the AO OUT connector.
7.3 Use with RadiAnalyzer Xpress
NOTE: Using Wi-Box in combination with RadiAnalyzer Xpress affects the performance of AO
measurements in RadiAnalyzer Xpress, see 13 Technical specifications, Performance below.
NOTE: Wi-Box cannot be used together with RadiAnalyzer Xpress if connected to a low power
hemodynamic recording system and a Wi-Box External power supply is needed.
a. Connect Xpress connector on Wi-Box to the AO IN connector on RadiAnalyzer Xpress using
Wi-Box Xpress cable.
b. Open the transducer to air and Zero AO on the RadiAnalyzer Xpress.
The white light on Wi-Box shall now be lit indicating that Wi-Box is powered.
The AO pressure presented on the hemodynamic recording system shall be equal to the AO
pressure presented on RadiAnalyzer Xpress.
8. DIRECTION FOR USE
WARNING: Do not touch AO IN or AO OUT connectors during a
clinical examination.
a. Establish a radio connection between Wi-Box and the receiving unit via the user interface. See
instructions for use for receiving unit.
AO pressure shall now be visible for use on the user interface and hemodynamic recording system.
9. DISPOSAL
Dispose Wi-Box in accordance with medical practice and applicable local, state and federal laws and
regulations.
10. CLEANING AND MAINTENANCE
Wi-Box shall only be cleaned with regular cleaning agents.
CAUTION: Do not immerse in liquid.
Do not use Wi-Box if it has been immersed in liquid.
Perform leakage current measurement on Wi-Box yearly. See Classifications below for information.
CAUTION: Perform leakage current measurement and functional test on Wi-Box if it has been subject
to mechanical damage.
CAUTION: Do not sterilize Wi-Box. Do not use Wi-Box if it has been subject to sterilization.
Software upgrade shall be performed by St. Jude Medical representative.
11. TECHNICAL SPECIFICATIONS
Electrical interface compatibility
ANSI/AAMI BP22 – 1994
Power Input:
2.4 to 8 VDC (for 2.4 to 4 VDC, use Wi-Box External Power Supply)
Transducer impedance:
>270 Ω
Wi-Box External Power Supply input:
100 to 240 VAC, 50-60 Hz
Performance
Accuracy:
<±1 mmHg or ±1% of reading whichever greatest
Resolution:
≤0.2 mmHg
Performance (cont'd.)
Bandwidth:
0-50 Hz
Xpress output bandwidth:
0-25 Hz
Physical
Weight:
130 g
Dimensions:
108 x 83 x 33 mm
Material:
Housing of PC.
Radio
Frequency range:
2.4000-2.4835 GHz (ISM-band)
Type:
Frequency Hopping Spread Spectrum
Range:
0-4m
Environmental conditions
Temperature:
10-40°C
Air humidity:
30-75%
Ambient pressure:
525-795 mmHg
Transport and storage
Transportation temperature:
-20°C to +70°C
Air humidity:
10%-95%
Ambient pressure:
375- 795 mmHg
Store at room temperature in a dry place.
Classifications
Wi-Box External Power Supply
Electrical safety Class II
AO IN, AO OUT
Galvanically connected together.
CF, Defibrillation Proof
EXPRESS/PSU
CF, Defibrillation Proof
12. COMPLIANCE WITH REGULATORY REQUIREMENTS
Hereby, St. Jude Medical Systems AB, declares that the Wi-Box is in compliance with the essential
requirements and other relevant provisions of Medical Device Directive (93/42/EEC), Radio and
Telecommunications Terminal Directive (1999/5/EC) and Quality System Regulation (US).
This device complies with part 15 of the FCC Rules and RSS-210 of the IC Rules. Operation is subject
to the following two conditions: (1) This device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired operation.
Guidance and manufacturer’s declaration – electromagnetic emissions
Wi-Box is intended for use in the electromagnetic environment specified below. The customer or the user of Wi-Box should assure
that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
Wi-Box 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
Harmonic emissions
IEC 61000-3-2
Class A
Wi-Box is 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.
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
Wi-Box is intended for use in the electromagnetic environment specified below. The customer or the user of Wi-Box 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
+/- 1 kV for input/output
lines
+/- 2 kV for power
supply lines
n/a for input/output lines
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
+/- 1 kV differential
mode
n/a for common mode
Mains power quality should be that of a typical
commercial or hospital environment.
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
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of Wi-Box requires continued operation during
power mains interruptions, it is recommended
that Wi-Box be powered from an uninterruptible
power supply or battery.
70 % UT (30 % dip in UT)
for 25 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 5 sec
3 A/m
3 A/m
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
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.
10
Guidance and manufacturer’s declaration – electromagnetic immunity
Wi-Box is intended for use in the electromagnetic environment specified below. The customer or the user of Wi-Box should assure
that it is used in such an environment.
Immunity test
IEC 60601 test level
Comp-liance level
Electromagnetic environment - guidance
Portable and mobile RF communications equipment
should be used no closer to any part of Wi-Box,
including 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 Vrms
Recommended separation distance
d = 1,2 √ P
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2,5 GHz
3 V/m
d = 1,2 √ P 80 MHz to 800 MHz
d = 2,3 √ P 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,1)
should be less than the compliance level in each
frequency range.2)
Interference may occur in the vicinity of equipment
marked with the following symbol.
NOTE: At 80MHz and 800 MHz, the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflected from
structures, objects and people.
1)
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 Wi-Box is used exceeds the applicable RF compliance level above, Wi-Box should be
observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating Wi-Box.
2)
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
11
Recommended separation distances between portable and mobile RF communications equipment
and Wi-Box
Wi-Box is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of Wi-Box can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and Wi-Box as
recommended below, according to the maximum output power of the communications equipment.
Rated maximum
output power of
transmitter
(W)
Separation distance according to frequency of transmitter
(m)
150 kHz to 80 MHz
d = 1,2 √ P
80 MHz to 800 MHz
d = 1,2 √ P
800 MHz to 2.5 GHz
d = 2,3 √ P
0.01
0.12
0.12
0.24
0.1
0.38
0.38
0.73
1.2
1.2
2.3
10
3.8
3.8
7.3
100
12
12
23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
meters (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: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
13. WARRANTY DISCLAIMER
Although Wi-Box, hereafter referred to as "product", have been manufactured under carefully controlled
conditions, St. Jude Medical Systems AB has no control over the conditions under which the product is
used. St. Jude Medical Systems AB, therefore disclaims all warranties, both express and implied, with
respect to the product, including, but not limited to, any implied warranty of merchantability or fitness for
a particular purpose. St. Jude Medical Systems AB shall not be liable to any person or entity for any
medical expenses or any direct, incidental or consequential damages caused by any use, defect,
failure or malfunction of the product, whether a claim for such damages is based upon warranty,
contract, tort or otherwise no person has any authority to bind St. Jude Medical Systems AB to any
representation or warranty with respect to the product. The exclusions and limitations set out above are
not intended to, and should not be construed so as to contravene mandatory provisions of applicable
law. If any part or term of this Disclaimer of Warranty is held to be illegal, unenforceable or in conflict
with applicable law by court of competent jurisdiction, the validity of the remaining portions of this
Disclaimer of Warranty shall not be affected, and all rights and obligations shall be construed and
enforced as if this Disclaimer of Warranty did not contain the particular part or term held to be invalid.
St. Jude Medical Systems AB
Palmbladsgatan 10
Box 6350, 751 35 Uppsala, SWEDEN
+46 (0) 18 16 10 00
www.sjm.com
12
14. EXPLANATION OF SYMBOLS
Follow instructions for use.
Equipment includes RF transmitter.
Electronic waste bin. Disposal according to WEEE.
Complies with Medical Device Directive 93/42/EEC and Radio Telecommunication Terminal Equipment Directive 1999/5/EC.
FCC identifier for the transmitter.
Industry Canada RF.
cETLus valid for Canada and US. Conforms to UL 60601-1.Certified to CAN/CSA STD C22.2 NO
601.1 –M90.
SN
Serial number.
READY
Unit ready for use.
NOT READY
Unit not ready for use.
Caution, (Attention, consult accompanying documents).
Defibrillation-proof Type CF equipment.
S pe cific Equipme nt
Only connect specified power supply equipment.
Manufacturer.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Product number.
Quantity.
Lot number.
Consult instructions for use.
Date of manufacture.
Made in S weden
Made in Sweden.
Instructions for use.
13
ATRIAL FIBRILLATION
CARDIAC RHYTM MANGEMENT
CARDIOVASCULAR
NEUROMODULATION
Global Headquarters
One St. Jude Medical Drive
St. Paul, Minnesota 55117
USA
+1 651 756 2000
+1 651 756 3301 Fax
Cardiovascular Division
177 East County Road B
St. Paul, Minnesota 55117
USA
+1 651 756 4470
+1 651 756 4466 Fax
St. Jude Medical Systems
AB
Box 6350
SE-751 35 Uppsala
Sweden
+46 18 161000
+46 18 161099 Fax
U.S. Division
6300 Bee Cave Road
Building Two, Suite 100
Austin, TX 78746
USA
+1 512 732 7400
+1 512 732 2418 Fax
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Avenue Da Vinci Iaan 11 Box F1
B-1935 Zaventem
Belgium
+32 2 774 68 11
+32 2 772 83 84 Fax
St. Jude Medical Japan Co.,
Ltd.
Shiodome City Center 15F
1–5–2, Higashi-Shinbashi,
Minato-ku
Tokyo 105–7115
Japan
+81 3 6255 6370
+81 3 6255 6371 Fax
St. Jude Medical (Hong
Kong) Ltd.
Suite 1608, 16/F Exchange
Tower
33 Wang Chiu Road
Kowloon Bay, Kowloon
Hong Kong SAR
+852 2996 7688
+852 2956 0622 Fax
St. Jude Medical Brasil Ltda.
Rua Frei Caneca, 1380
7º ao 9º andares
01307-002 - São Paulo (SP)
Brazil
+55 11 5080 5400
+55 11 5080 5423 Fax
SJMprofessional.com
Wi-Box is designed, developed and manufactured by St. Jude Medical Systems AB. Patent
Pending. Unless otherwise noted, ™ indicates a registered or unregistered trademark or service
mark owned by, or licensed to, St. Jude Medical, Inc. or one of its subsidiaries. RadiAnalyzer
Xpress, RADI, ST. JUDE MEDICAL, the nine-squares symbol, and MORE CONTROL. LESS RISK.
are registered and unregistered trademarks and service marks of St. Jude Medical, Inc. and its
related companies.
©2011 St. Jude Medical, Inc. All rights reserved.
22023
Rev. A
2011-06

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.3
Linearized                      : No
Warning                         : Duplicate 'PageMode' entry in dictionary (ignored)
Page Count                      : 16
Page Mode                       : UseOutlines
Page Layout                     : OneColumn
Create Date                     : 2011:06:01 17:16:53
Producer                        : Arbortext Advanced Print Publisher 10.0.1376/W Library
Creator                         : Arbortext Publishing Engine R54M090-1056

EXIF Metadata provided by EXIF.tools