Radi PressureWire Aeris Скачать руководство пользователя страница 15

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PressureWire

is developed and manufactured according to Medical Device

Directive, Radio and Telecommunication Terminal Equipment Directive 199/5/EC and
QSR (US).

PressureWire

and RadiAnalyzer

are registered trademarks of Radi Medical

Systems AB.

Designed, developed and manufactured by:

Radi Medical Systems AB
Palmbladsgatan 10, SE-754 50 Uppsala, Sweden
Tel + 46 (0) 18 16 10 00, Fax: 46 (0) 18 16 10 99
e-mail:

[email protected]

Radi Medical System contacts and further information:

www.radi.se

Содержание PressureWire Aeris

Страница 1: ... STATEMENT TRANSPORT STORAGE TRANSMITTER LIGHT INDICATORS COMPLIANCE WITH REGULATORY REQUIREMENTS RoHS DECLARATION for Chinese IFU only PATENTS WARRANTY AND LIMITATIONS SYMBOLS WITH EXPLANATIONS CONTENTS 0 014 0 36 mm guidewire Disconnectable transmitter to be used with the guidewire it is delivered with Torque device DESCRIPTION See Diagram 1 PressureWire 0 014 0 36 mm is a guidewire with a high ...

Страница 2: ...ged or distorted Prior to use and when possible during the procedure inspect PressureWire carefully for bends kinks or other damage Do not readjust any bend or kink PressureWire must not be used if it has been damaged in any way otherwise vessel ventricle damage and or inaccurate pressure signals or inaccurate torque response may occur When introducing PressureWire in a diagnostic case flush the c...

Страница 3: ...ssureWire does not give sufficient support for guiding catheter exchange Do not use with interventional devices with a too short guidewire rail length as PressureWire may fold or fracture during manipulation Confirm the compatibility of PressureWire diameter with the interventional device before actual use Free movement of the guidewire within the interventional device is an important feature of a...

Страница 4: ...le local state and federal laws and regulations NOTE The transmitter contains silver oxide button type batteries with in total 2 mercury allowed to be put on the market according to the battery directive 2006 66 EG The signal performance requires the batteries to be permanently affixed and the transmitter to be sealed which according to article 11 in the same directive exclude the batteries from t...

Страница 5: ...t established within 60s the receiver returns to standby mode indicated by a yellow light and a long beep Reactivate the receiver by pressing the CONNECT button then restart the transmitter by turning it off and then on again After calibration confirm that the pressure reading on the cathlab monitor is zero re zero the cathlab pressure channel if necessary PressureWire is now ready for use Avoid t...

Страница 6: ...essure from the guiding catheter and the PressureWire pressure are similar 7 8 To remove any residual pressure difference between aortic and PressureWire pressure use the equalization function on the Cathlab monitor system or use the plus and minus buttons on PressureWire Receiver Refer to the Instructions for use for the Cathlab monitor or the Instructions for use for PressureWire Receiver WARNIN...

Страница 7: ...rtuous subclavian artery or adjacent vessel position the junction between the shaft and the flexible distal section of the wire E 31 cm from the tip may be vulnerable to kinking or fracture Avoid use of PressureWire via a radial or brachial approach unless this approach is based on medical necessity If a decision is taken to continue with an interventional procedure follow these instructions 8 DIR...

Страница 8: ... Position the sensor element of PressureWire just outside of the tip of the guiding catheter o Flush any remaining contrast fluids o Pull back the insertion tool out of the hemostatic valve o Tighten the hemostatic valve o Verify that the pressures registered by the guiding catheter and PressureWire are the same 9 DIRECTIONS FOR USE INTRACARDIAC MEASUREMENTS WARNING When introducing the guidewire ...

Страница 9: ...atheter 9 4 Advance PressureWire into the position of interest WARNING Observe all PressureWire movement Whenever PressureWire is moved or torqued the tip movement should be examined under fluoroscopy 9 5 Pull back the catheter to a stable position outside the heart valve leaving only PressureWire at the measurement position CAUTION Whenever absolute blood pressure measurements are obtained the pr...

Страница 10: ...ansmitter This device complies with part 15 of the FCC 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 WARNING Changes or modifications not expressly approved by Radi Medical Systems AB could void the user s authority to opera...

Страница 11: ... declaration electromagnetic emissions PressureWire system is intended for use in the electromagnetic environment specified below The customer or the user of PressureWire system should assure that it is in such an environment Emission test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The PressureWire system uses RF energy only for its internal function Therefore it...

Страница 12: ...er frequency 50 60 Hz magnetic filed IEC 61000 4 8 3 A m 3 A m 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 1 No mains power input 2 Patient connection Guidance and manufacturer s declaration electromagnetic immunity The PressureWire sy...

Страница 13: ...ystem should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the PressureWire system b Over the frequency range 150KHz to 80MHz field strengths should be less than 3 V m 1 No mains power input Recommended separation distances between portable and mobile RF communications equipment and the PressureWire...

Страница 14: ...conditions under which the product is used Radi therefore disclaims all warranties both expressed and implied with respect to the product including but not limited to any implied warranty of merchantability or fitness for a particular purpose Radi 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 ...

Страница 15: ...tive 199 5 EC and QSR US PressureWire and RadiAnalyzer are registered trademarks of Radi Medical Systems AB Designed developed and manufactured by Radi Medical Systems AB Palmbladsgatan 10 SE 754 50 Uppsala Sweden Tel 46 0 18 16 10 00 Fax 46 0 18 16 10 99 e mail radi radi se Radi Medical System contacts and further information www radi se ...

Страница 16: ...Expiry date 2 years from manufacturing date Contents of the package REF Catalogue number Lot number QTY Quantity Type CF equipment Equipment includes RF transmitter Electrostatic sensitive device Do not use if package is damaged For single use only Do not reuse Do not re sterilize Sterilized using Ethylene Oxide ...

Страница 17: ...ame directive exclude the batteries from the requirement to be possible to remove Dispose as ordinary potentially biohazardous material Complies with the Medical Device Directive 93 42 EEC and Radio and Telecommunication Terminal Equipment Directive 199 5 EC FCC ID U4L01080410 FCC identifier for the transmitter No toxic and hazardous substances according to RoHS contained This mark for the Chinese...

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