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Ampere™ Generator Instructions for Use
International Edition Rev. A 100081509-en

Warning General
Serious injury can occur if care is not
taken during use of the system.

Caution

Notified body CE Mark

Authorized representative in the
European community

Input Voltage, Input Frequency and
Replacement fuse information

Software

In Metro Mark - Brazil

Intertek Safety Agency
Certification
Mark

On GenConnect: GenConnect cable
connector

On EnSite™ Velocity™ Cardiac Mapping
System Amplifier: Fiber optic cable
connector

Dispersive patch cable connector

Ablation catheter cable connector

Telephone

Facsimile

Symbol

Description

REP

Ablate

Preset

Up Button

Down Button

Standby Button

Electrogram Cable Connection

Footswitch Connection

USB Connection

Monitor Connection

Pump Connection

Remote Connection

Remote Control

Generator Accessories

Rated Voltage

Symbol

Description

Содержание Ampere Generator

Страница 1: ...ul MN 55117 USA St Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium afcustomerservice sjm com www sjm com WARNING The use of this device in conjunction with a radio frequency ablation catheter as a part of the diagnosis and treatment of cardiac arrhythmias may pose an increased risk of adverse events such as cardiac perforation myocardial inf...

Страница 2: ...tch AC Power Power Plug Equipotential jack Non sterile Do not reuse On carton Transport storage temperature limitation Operating temperature Humidity limitation Weight Fragile Keep dry Manufacturer Date of Manufacture Use by date Lot number Catalog number Serial number Finished Goods number Made in U S A Not for direct patient contact Consult the Instruction for Use Dispose of hardware in accordan...

Страница 3: ...Mark Brazil Intertek Safety Agency Certification Mark On GenConnect GenConnect cable connector On EnSite Velocity Cardiac Mapping System Amplifier Fiber optic cable connector Dispersive patch cable connector Ablation catheter cable connector Telephone Facsimile Symbol Description EC REP Ablate Menu Preset Up Button Down Button Standby Button Electrogram Cable Connection Footswitch Connection USB C...

Страница 4: ...on Rev A 100081509 en Rated Current Footswitch Generator Non ionizing electromagnetic radiation Cables Cords Package Contents IP68 Footswitch enclosure is dust tight and protected against submersion in water Neutral Electrode Floating Ground Symbol Description ...

Страница 5: ... the Cool Point Irrigation pump Other important information has also been supplied for the user s convenience Precaution DO NOT attempt to operate the Ampere Generator before thoroughly reading this Instructions for Use The Ampere Generator Instructions for Use should be read understood and followed carefully For future reference keep this manual in a convenient readily accessible place Indication...

Страница 6: ...lso accessible from the front panel Additional display and ablation control options are accessed through a menu and turn knob control RF energy can be turned on or off from a single push button A standby button is also available for emergency cutoff of RF energy Displays and controls on the main unit are identical on the optional remote control such that changes made to settings on either the main...

Страница 7: ...on the front panel to disable RF delivery automatic RF shutoff if the impedance 50 ohms or 300 ohms or greater than the user set impedance limit and automatic RF shutoff if the catheter temperature 80 C or if the catheter temperature exceeds the user set temperature by more than 5 C for more than 3 seconds System Hardware Components Ampere Generator Footswitch Cables Country specific power cords E...

Страница 8: ...the ablation procedure c exercise extreme caution during ablation when in close proximity to atrial or ventricular permanent pacing leads and d perform complete pacing system analysis on all patients after ablation WARNING Ablation within the coronary arterial vasculature has been associated with myocardial infarction and death WARNING Patients undergoing left sided ablation procedures should be c...

Страница 9: ... otherwise the default values will be used CAUTION Choose the lowest possible output power for the intended purpose CAUTION Read and follow the DIP electrode manufacturer s instructions for use CAUTION Standard grounding procedures should be followed if electrosurgical instruments are used CAUTION The Ampere Generator is capable of delivering significant electrical power Patient or operator injury...

Страница 10: ...ther device s are connected 4 Consult the manufacturer for help CAUTION Follow the system installation to achieve optimal use CAUTION When used in conjunction with Cool Point Irrigation Pump 1 Refer to the Cool Point Irrigation Pump operator manual to troubleshoot the Cool Point Irrigation Pump 2 The Cool Point Irrigation Pump tubing set is required for use 3 If the communication cable used betwee...

Страница 11: ...enu 4 assignable presets and default settings 5 Standby Button Red light is on while in standby Standby message displays on screen Press to toggle On Off Standby Both the main and Remote unit Standby buttons must be Off to disengage Standby 6 EGM Connector For connecting to an EP recording system to display the intracardiac signal 7 Indifferent Electrode Connectors 2 For connecting the Ampere Gene...

Страница 12: ...er Watts of power to be delivered to the catheter location Arrows increase decrease power threshold in 1 Watt increments 4 User Set Temperature Temperature to be reached at the catheter sensor location Arrows increase decrease temperature threshold in 1 C increments 5 User Set Impedance Impedance between the ablation electrode and the DIP electrode s If impedance goes above set limit RF energy del...

Страница 13: ...F energy delivery power is 50 Watts only one Disposable Indifferent Patch is required Yellow Programmed RF energy delivery power is 50 Watts two Disposable Indifferent Patchs are required Catheter Gray Catheter is not connected Green Catheter is connected Remote Control Gray Remote control is not connected Green Remote control is connected and communicating with the Ampere Generator Footswitch Gra...

Страница 14: ...ord plug in 5 Fiber Optic Connector Single Fiber Optic port to connect to the optional Remote Control 6 Dual Fiber Optic Connector Dual fiber optic port to connect to the optional Remote Control 7 Fiber Optic Transceiver Connector Fiber optic port for future use 8 USB Port USB memory stick connection 9 DB 15 Serial Port female Connection for Cool Point Irrigation Pump interface 10 DB9 Serial Port ...

Страница 15: ...nit or Remote Control enters standby mode which disables all output until the button is released Both the main unit s and the Remote Control s Standby button must be released to terminate standby mode Ablation Continues from 1 999 seconds Safety Class Class I Type CF according to IEC 60601 1 Operating Frequency 485 kHz Operating Parameters Values are digitally displayed on the Ampere Generator fro...

Страница 16: ...erature 10oC to 35oC Relative humidity 20 to 90 non condensing The operating ambient altitude range shall be 0m to 3000m 9843 The Ampere Generator is intended for use in the electromagnetic environment specified below The customer or the user of the Ampere Generator should assure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF emissions CISP...

Страница 17: ...EN61000 4 5 IEC 1000 4 5 1 kV differential mode 2 kV common mode 1 kV 2 kV 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 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 95 dip in VNOM for...

Страница 18: ...by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects...

Страница 19: ...pment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 117 117 233 10 369 369 737 1 1 167 1 167 2 33 10 3 69 3 69 7 37 100 11 67 11 67 23 33 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the e...

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