St Jude Medical 201106 Wi-Box User Manual

St Jude Medical Systems AB Wi-Box Users Manual

Users Manual

Wi-Box™
ENGLISH 4
ENGLISH1. PRODUCT NAMEWi-Box™2. CONTENTWi-BoxWi-Box Xpress Cable(Ordered separately.)Wi-Box External Power Supply(Ordered separately.)Wi-Box Excitation plug(Ordered separately.)3. DESCRIPTIONWi-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 connectedto the pressure transducer at the same time as Wi-Box measures the pressure and transmits it on aspecific radio interface.An isolated interface provides the measured pressure as an analog output signal.4. INDICATION FOR USEWi-Box is indicated to condition and transmit a physiological signal via radiofrequency.5. GENERAL WARNINGSWireless transmitter and RadiAnalyzer™Xpress pressure output ports are not designed nor intendedfor vital signs monitoring.Modification of this equipment is not allowed.4
6. GENERAL PRECAUTIONSFederal (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 andregulations.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 measurementand functional test.Software upgrade shall not be performed during a clinical procedure.7. INSTALLATION7.1 Normal OperationNOTE: Wi-Box needs to be installed in a place that ensures adequate radio transmission with receivingunit.Radio range is reduced by objects and walls, keep Wi-Box and receiving unit in line of sight whereverpossible.NOTE: High frequency surgical equipment shall not be used in the close proximity of the device sincethis 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 andto protect the unit from ingression of fluids.NOTE: After mounting, Wi-Box is securely fastened and may be very difficult to remove. If Wi-Boxneeds to be repositioned, be careful not to damage Wi-Box by bending.CAUTION: The used pressure transducer must have excitationimpedance larger than 270 Ω.CAUTION: All equipment connected to AO OUT must be CFclassified and defibrillation proof. Failure to comply to theserequirements will void the CF classification and defibrillationprotection on AO IN.CAUTION: The person performing the connections of Wi-Box isresponsible for forming a medical electrical system and the totalsystem and patient leakage currents thereof.5
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-BP22compatible hemodynamic recording system using the corresponding St. Jude Medical monitorcable.c. Connect the blood pressure transducer to the AO IN using the corresponding St. Jude Medicaladapter cable. For appropriate handling of the external pressure transducer (calibration, removingpossible entrapped air, sterility, time limit before use, warm-up time or volume displacement) refer toits 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 bloodpressure simulator.If the green READY light is lit and the AO pressure is correctly displayed on the hemodynamicrecording system, Wi-Box is ready to use.If the red NOT READY light is lit or the AO pressure is incorrectly displayed on the hemodynamicrecording system, Wi-Box External Power supply needs to be connected to provide adequate power tothe 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 itis protected from fluids.CAUTION: Mains power is disconnected by removing Wi-BoxExternal Power Supply from the wall socket. Place Wi-Box ExternalPower Supply such that it easily can be removed from the wallsocket.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 socketadapter.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 bloodpressure simulator.If the green READY light is lit and the AO pressure is correctly displayed on the hemodynamicrecording 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-BoxExternal Power Supply. If the problem remains contact your St. Jude Medical representative. If theAO 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-BoxExcitation Plug shall be inserted in the AO OUT connector.6
7.3 Use with RadiAnalyzer XpressNOTE: Using Wi-Box in combination with RadiAnalyzer Xpress affects the performance of AOmeasurements in RadiAnalyzer Xpress, see 13 Technical specifications, Performance below.NOTE: Wi-Box cannot be used together with RadiAnalyzer Xpress if connected to a low powerhemodynamic 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 usingWi-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 AOpressure presented on RadiAnalyzer Xpress.8. DIRECTION FOR USEWARNING: Do not touch AO IN or AO OUT connectors during aclinical examination.a. Establish a radio connection between Wi-Box and the receiving unit via the user interface. Seeinstructions for use for receiving unit.AO pressure shall now be visible for use on the user interface and hemodynamic recording system.9. DISPOSALDispose Wi-Box in accordance with medical practice and applicable local, state and federal laws andregulations.10. CLEANING AND MAINTENANCEWi-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 subjectto 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 SPECIFICATIONSElectrical interface compatibilityANSI/AAMI BP22 –1994Power Input: 2.4 to 8 VDC (for 2.4 to 4 VDC, use Wi-Box External Power Supply)Transducer impedance: >270 ΩWi-Box External Power Supply input: 100 to 240 VAC, 50-60 HzPerformanceAccuracy: <±1 mmHg or ±1% of reading whichever greatestResolution: ≤0.2 mmHg7
Performance (cont'd.)Bandwidth: 0-50 HzXpress output bandwidth: 0-25 HzPhysicalWeight: 130 gDimensions: 108 x 83 x 33 mmMaterial: Housing of PC.RadioFrequency range: 2.4000-2.4835 GHz (ISM-band)Type: Frequency Hopping Spread SpectrumRange: 0 - 4 mEnvironmental conditionsTemperature: 10-40°CAir humidity: 30-75%Ambient pressure: 525-795 mmHgTransport and storageTransportation temperature: -20°C to +70°CAir humidity: 10%-95%Ambient pressure: 375- 795 mmHgStore at room temperature in a dry place.ClassificationsWi-Box External Power Supply Electrical safety Class IIAO IN, AO OUT Galvanically connected together.CF, Defibrillation ProofEXPRESS/PSU CF, Defibrillation Proof8
12. COMPLIANCE WITH REGULATORY REQUIREMENTSHereby, St. Jude Medical Systems AB, declares that the Wi-Box is in compliance with the essentialrequirements and other relevant provisions of Medical Device Directive (93/42/EEC), Radio andTelecommunications 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 subjectto the following two conditions: (1) This device may not cause harmful interference, and (2) this devicemust accept any interference received, including interference that may cause undesired operation.Guidance and manufacturer’s declaration –electromagnetic emissionsWi-Box is intended for use in the electromagnetic environment specified below. The customer or the user of Wi-Box should assurethat it is used in such an environment.Emissions test Compliance Electromagnetic environment - guidanceRF emissionsCISPR 11Group 1 Wi-Box uses RF energy only for its internal function.Therefore, its RF emissions are very low and are notlikely to cause any interference in nearby electronicequipment.RF emissionsCISPR 11Class B Wi-Box is suitable for use in all establishmentsincluding domestic establishments and those directlyconnected to the public low-voltage power supplynetwork that supplies buildings used for domesticpurposes.Harmonic emissionsIEC 61000-3-2Class AVoltage fluctuations/ flicker emissionsIEC 61000-3-3Complies9
Guidance and manufacturer’s declaration –electromagnetic immunityWi-Box is intended for use in the electromagnetic environment specified below. The customer or the user of Wi-Box should assurethat it is used in such an environment.Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidanceElectrostatic discharge(ESD)IEC 61000-4-2+/- 6 kV contact+/- 8 kV air+/- 6 kV contact+/- 8 kV airFloors should be wood, concrete or ceramictile.If floors are covered with synthetic material, therelative humidity should be at least 30 %.Electrical fast transient/BurstIEC 61000-4-4+/- 2 kV for powersupply lines+/- 1 kV for input/outputlines+/- 2 kV for powersupply linesn/a for input/output linesMains power quality should be that of a typicalcommercial or hospital environment.SurgeIEC 61000-4-5+/- 1 kV differentialmode+/- 2 kV common mode+/- 1 kV differentialmoden/a for common modeMains power quality should be that of a typicalcommercial or hospital environment.Voltage dips, shortinterruptions and voltagevariations on powersupply input linesIEC 61000-4-11<5 % UT(>95 % dip inUT) for 0,5 cycle40 % UT(60 % dip in UT)for 5 cycles70 % UT(30 % dip in UT)for 25 cycles<5 % UT(>95 % dip inUT) for 5 sec<5 % UT(>95 % dip inUT) for 0,5 cycle40 % UT(60 % dip in UT)for 5 cycles70 % UT(30 % dip in UT)for 25 cycles<5 % UT(>95 % dip inUT) for 5 secMains power quality should be that of a typicalcommercial or hospital environment. If the userof Wi-Box requires continued operation duringpower mains interruptions, it is recommendedthat Wi-Box be powered from an uninterruptiblepower supply or battery.Power frequency (50/60Hz) magnetic fieldIEC 61000-4-83 A/m 3 A/m Power frequency magnetic fields should be atlevels characteristic of a typical location in atypical commercial or hospital environmentNOTE: UTis the a.c. mains voltage prior to application of the test level.10
Guidance and manufacturer’s declaration –electromagnetic immunityWi-Box is intended for use in the electromagnetic environment specified below. The customer or the user of Wi-Box should assurethat it is used in such an environment.Immunity test IEC 60601 test level Comp-liance level Electromagnetic environment - guidancePortable and mobile RF communications equipmentshould be used no closer to any part of Wi-Box,including cables, than the recommended separationdistance calculated from the equation applicable tothe frequency of the transmitter.Conducted RFIEC 61000-4-63 Vrms150 kHz to 80 MHz3 Vrms Recommended separation distanced= 1,2 √PRadiated RFIEC 61000-4-33 V/m80 MHz to 2,5 GHz3 V/md= 1,2 √P 80 MHz to 800 MHzd= 2,3 √P 800 MHz to 2,5 GHzwhere P is the maximum output power rating of thetransmitter in watts (W) according to the transmittermanufacturer anddis the recommended separationdistance in meters (m).Field strengths from fixed RF transmitters, asdetermined by an electromagnetic site survey,1)should be less than the compliance level in eachfrequency range.2)Interference may occur in the vicinity of equipmentmarked 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 fromstructures, objects and people.111) 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 theelectromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measuredfield strength in the location in which Wi-Box is used exceeds the applicable RF compliance level above, Wi-Box should beobserved to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such asreorienting or relocating Wi-Box.2) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
Recommended separation distances between portable and mobile RF communications equipmentand Wi-BoxWi-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 minimumdistance between portable and mobile RF communications equipment (transmitters) and Wi-Box asrecommended below, according to the maximum output power of the communications equipment.Rated maximumoutput power oftransmitter(W)Separation distance according to frequency of transmitter(m)150 kHz to 80 MHzd= 1,2 √P80 MHz to 800 MHzd= 1,2 √P800 MHz to 2.5 GHzd= 2,3 √P0.01 0.12 0.12 0.240.1 0.38 0.38 0.731 1.2 1.2 2.310 3.8 3.8 7.3100 12 12 23For transmitters rated at a maximum output power not listed above, the recommended separation distance d inmeters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is themaximum 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 absorptionand reflection from structures, objects and people.13. WARRANTY DISCLAIMERAlthough Wi-Box, hereafter referred to as "product", have been manufactured under carefully controlledconditions, St. Jude Medical Systems AB has no control over the conditions under which the product isused. St. Jude Medical Systems AB, therefore disclaims all warranties, both express and implied, withrespect to the product, including, but not limited to, any implied warranty of merchantability or fitness fora particular purpose. St. Jude Medical Systems AB shall not be liable to any person or entity for anymedical 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 anyrepresentation or warranty with respect to the product. The exclusions and limitations set out above arenot intended to, and should not be construed so as to contravene mandatory provisions of applicablelaw. If any part or term of this Disclaimer of Warranty is held to be illegal, unenforceable or in conflictwith applicable law by court of competent jurisdiction, the validity of the remaining portions of thisDisclaimer of Warranty shall not be affected, and all rights and obligations shall be construed andenforced as if this Disclaimer of Warranty did not contain the particular part or term held to be invalid.St. Jude Medical Systems ABPalmbladsgatan 10Box 6350, 751 35 Uppsala, SWEDEN+46 (0) 18 16 10 00www.sjm.com12
14. EXPLANATION OF SYMBOLSFollow 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 Equip-ment 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 NO601.1 –M90. SN Serial number.READYUnit ready for use.NOT READYUnit not ready for use.Caution, (Attention, consult accompanying documents).Defibrillation-proof Type CF equipment.Specific Equipment 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 wedenMade in Sweden.Instructions for use.13
ATRIAL FIBRILLATION CARDIAC RHYTM MANGEMENT CARDIOVASCULAR NEUROMODULATIONGlobal HeadquartersOne St. Jude Medical DriveSt. Paul, Minnesota 55117USA+1 651 756 2000+1 651 756 3301 FaxCardiovascular Division177 East County Road BSt. Paul, Minnesota 55117USA+1 651 756 4470+1 651 756 4466 FaxSt. Jude Medical SystemsABBox 6350SE-751 35 UppsalaSweden+46 18 161000+46 18 161099 FaxU.S. Division6300 Bee Cave RoadBuilding Two, Suite 100Austin, TX 78746USA+1 512 732 7400+1 512 732 2418 FaxSt. Jude MedicalCoordination Center BVBAThe Corporate VillageAvenue Da Vinci Iaan 11 Box F1B-1935 ZaventemBelgium+32 2 774 68 11+32 2 772 83 84 FaxSt. Jude Medical Japan Co.,Ltd.Shiodome City Center 15F1–5–2, Higashi-Shinbashi,Minato-kuTokyo 105–7115Japan+81 3 6255 6370+81 3 6255 6371 FaxSt. Jude Medical (HongKong) Ltd.Suite 1608, 16/F ExchangeTower33 Wang Chiu RoadKowloon Bay, KowloonHong Kong SAR+852 2996 7688+852 2956 0622 FaxSt. Jude Medical Brasil Ltda.Rua Frei Caneca, 13807º ao 9º andares01307-002 - São Paulo (SP)Brazil+55 11 5080 5400+55 11 5080 5423 FaxSJMprofessional.comWi-Box is designed, developed and manufactured by St. Jude Medical Systems AB. PatentPending. Unless otherwise noted, ™indicates a registered or unregistered trademark or servicemark owned by, or licensed to, St. Jude Medical, Inc. or one of its subsidiaries. RadiAnalyzerXpress, 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 itsrelated companies.©2011 St. Jude Medical, Inc. All rights reserved.22023 Rev. A 2011-06

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