St. Jude Medical Wi-Box AO Transmitter User manual

Wi-Box™
AO Transmitter
EN: Instructions for use
FR: Mode d’emploi
PT: Instruções de utilização
BG: Указания за употреба
HU: Használati utasítás
RO: Instrucţiuni de utilizare
CS: Návod k použití
IT: Istruzioni per l'uso
RU
: Инструкция по эксплуатации
DA: Brugervejledning
KO:
사용 설명서
SK:
Návod na použitie
DE: Gebrauchsanweisung
LT: Naudojimo instrukcijos
SR: Uputstvo za upotrebu
EL: Οδηγίες χρήσης
LV: Lietošanas pamācība
SV: Bruksanvisning
ES: Instrucciones de uso
NL: Geb
ruiksaanwijzing
TR: Kullanma Talimatları
ET: Kasutusjuhised
NO: Bruksanvisning
FI: Käyttöohjeet
PL: Instrukcja obsługi
Instructions for Use

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its
subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of
St. Jude Medical, Inc. and its related companies. © 2015 St. Jude Medical, Inc. All Rights Reserved.
Pat. http://patents.sjm.com

EN: Instructions for use .............................................................................................1
BG: Указания за употреба.......................................................................................13
CS: Návod k použití .................................................................................................27
DA: Brugervejledning...............................................................................................39
DE: Gebrauchsanweisung........................................................................................51
EL: Οδηγίες χρήσης..................................................................................................64
ES: Instrucciones de uso .........................................................................................77
ET: Kasutusjuhised..................................................................................................90
FI: Käyttöohjeet .....................................................................................................102
FR: Mode d’emploi................................................................................................114
HU: Használati utasítás .........................................................................................127
IT: Istruzioni per l'uso ............................................................................................139
KO: 사용 설명서..................................................................................................152
LT: Naudojimo instrukcijos ....................................................................................165
LV: Lietošanas pamācība .......................................................................................177
NL: Gebruiksaanwijzing .........................................................................................189
NO: Bruksanvisning...............................................................................................202
PL: Instrukcja obsługi ............................................................................................214
PT: Instruções de utilização...................................................................................227
RO: Instrucţiuni de utilizare ...................................................................................240
RU: Инструкция по эксплуатации .........................................................................252
SK: Návod na použitie ...........................................................................................266
SR: Uputstvo za upotrebu......................................................................................279
SV: Bruksanvisning ...............................................................................................291
TR: Kullanma Talimatları .......................................................................................303

EN: English
Wi-Box™ AO Transmitter
Product Name
Wi-Box™ AO transmitter
Contents
Wi-Box AO transmitter
Wi-Box™ Xpress cable
(Ordered separately.)
Wi-Box™ external power supply
(Ordered separately.)
Wi-Box™ excitation plug
(Ordered separately.)
Description
Wi-Box™ AO transmitter 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 it measures the pressure and
transmits it on a specific radio interface. An isolated interface provides the measured pressure as an
analog output signal.
1

Indications for Use
PressureWire™ Net is indicated to condition a physiological signal from the cardiovascular system,
transmit and receive via radiofrequency, and recondition the signal to its original format so that it
can be displayed. The physiological signal can also be distributed via cable.
Intended Use
PressureWire™ Net is intended to condition physiological signals from measuring devices
(PressureWire™ guidewire and an external pressure transducer), transmit and receive via
radiofrequency, and reconditions the signals to its original format so that those can be displayed on
and/or recorded in a receiving device (RadiAnalyzer™ Xpress or other monitor systems). The
physiological signals can also be distributed via cable.
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.
General Precautions
Federal (USA) law restricts distribution and sales of this device to sale by or on the order of a
physician.
Handle this device in accordance with medical practice and applicable local, state and federal
laws and regulations.
Do not use this device if it has been subject to damage.
If this device 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.
Installation
Normal Operation
NOTE
The Wi-Box™ AO transmitter needs to be installed in a place that ensures adequate
radio transmission with receiving unit. Radio range is reduced by objects and walls,
keep the Wi-Box AO transmitter and receiving unit in a line of sight wherever
possible.
High frequency surgical equipment shall not be used in the close proximity of the
device since this could influence the performance of the device.
1. Mount the Wi-Box™ unit 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.
2

Figure 1. Mounted Wi-Box unit
NOTE
After mounting, the Wi-Box unit is securely fastened and may be very difficult to remove.
If it needs to be repositioned, be careful not to damage the unit by bending.
CAUTION

The used pressure transducer must have excitation impedance larger than
270 Ω.

All equipment connected to AO OUT must be CF classified and defibrillation
proof. Failure to comply with these requirements will void the CF classification
and defibrillation protection on AO IN.

The person performing the connections of the Wi-Box AO transmitter 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.
2. Connect the AO OUT connector on the Wi-Box unit to a blood pressure channel on the
ANSI/AAMI-BP22 compatible hemodynamic recording system using the corresponding
St. Jude Medical™ monitor cable.
3. 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.
To ensure correct operation, the AO transducer must be directly connected to the
Wi-Box AO transmitter without the use of any intermediary multi-channel cable
adapters (see figure below).
3

Figure 2. Connecting AO transducer to Wi-Box AO transmitter if a multi-channel cable adapter is in
use
1. AO transducer
2. Wi-Box AO transmitter
3.
Hemodynamic recording
system
4. Multi-channel cable
adapter
5. Single-channel cable
1. Make sure that the blood pressure channel is powered.
2. 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, the Wi-Box AO transmitter is ready to use.
If the red NOT READY light is lit or the AO pressure is incorrectly displayed on the hemodynamic
recording system, the Wi-Box™ external power supply needs to be connected to provide adequate
power to the unit (see the Wi-Box External Power Supply section below).
If the red NOT READY light is blinking, internal fail has occurred. Contact your St. Jude Medical
representative.
Wi-Box™ External Power Supply (for Low Power Hemodynamic
Recording Systems)
CAUTION

The only approved power supply to connect is
C12785/FW7333SM.

The power supply shall be mounted at a location where it is
protected from fluids.

Mains power is disconnected by removing the Wi-Box™
external power supply from the wall socket. Place the Wi-Box
external power supply such that it easily can be removed from
the wall socket.
1. Connect the Wi-Box external power supply cable to the PSU connector on the Wi-Box™ unit.
2. Connect the Wi-Box external power supply to a free wall socket using the appropriate wall
socket adapter.
The white light on the Wi-Box unit shall now be lit, indicating that the device is powered.
3. 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, the Wi-Box AO transmitter is ready to use.
If the red NOT READY light still is lit, an internal error has occurred. Try to reconnect the
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 AO transmitter. Contact a St. Jude Medical representative.
4

4. If the Wi-Box AO transmitter is intended to be used stand-alone without a hemodynamic
recording system, the Wi-Box™ excitation plug shall be inserted in the AO OUT connector.
Use with RadiAnalyzer Xpress™ Measurement System
NOTE
Using the Wi-Box™ AO transmitter in combination with the RadiAnalyzer™ Xpress
measurement system affects the performance of AO measurements in the
RadiAnalyzer Xpress measurement system (see Performance (page 6)).
The Wi-Box AO transmitter cannot be used together with the RadiAnalyzer Xpress
measurement system if connected to a low power hemodynamic recording system
and a Wi-Box™ external power supply is needed.
1. Connect the Xpress connector on the Wi-Box™ unit to the AO IN connector on the
RadiAnalyzer Xpress measurement system using the Wi-Box™ Xpress cable.
2. Open the transducer to air and zero AO on the RadiAnalyzer Xpress measurement system. The
white light on the Wi-Box unit shall now be lit indicating that the device is powered.
The AO pressure presented on the hemodynamic recording system shall be equal to the AO
pressure presented on the RadiAnalyzer Xpress measurement system.
Directions for Use
WARNING
Do not touch AO IN or AO OUT connectors during a clinical examination.
Establish a radio connection between the Wi-Box™ AO transmitter 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.
Disposal
Dispose of this device in accordance with medical practice and applicable local, state and federal
laws and regulations.
Cleaning and Maintenance
This device shall only be cleaned with regular cleaning agents.
CAUTION
Do not immerse in liquid.
Do not use this device if it has been immersed in liquid.
Perform leakage current measurement on the Wi-Box™ AO transmitter yearly. See Classifications
(page 7) for information.
CAUTION
Perform leakage current measurement and functional test on the Wi-Box AO
transmitter if it has been subject to mechanical damage.
Do not sterilize this device. Do not use this device if it has been subject to
sterilization.
Software upgrade shall be performed by a St. Jude Medical representative.
5

Technical Specifications
Table 1. 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
Table 2. Performance
Accuracy: <±1 mmHg or ±1% of reading whichever greatest
Resolution: ≤0.2 mmHg
Bandwidth: 0-50 Hz
Xpress output bandwidth: 0-25 Hz
Table 3. Physical
Weight: 130 g
Dimensions: 108 x 87 x 33 mm
Material: Housing of PC.
Table 4. Radio
Frequency range: 2.4000-2.4835 GHz (ISM-band)
Type: Frequency Hopping Spread Spectrum
Range: 0 - 4m
Table 5. Environmental conditions
Temperature: 10-40°C
Air humidity: 30-75%
Ambient pressure: 525-795 mmHg
Table 6. 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.
6