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Boston Scientific Maestro 3000, Руководство по подключению

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Blazer

™

 Open-Irrigated Ablation Catheter with

Compatible Generator and Pump

Product illustrations designed by Boston Scientific, not actual photos. 

The Blazer Open-Irrigated Ablation Catheter has been tested and verified to operate safely with the 

Stockert Radiofrequency Generator and Biosense Webster CoolFlow

®

 Irrigation Pump. Data on file.

Sterile, normal (0.9%),

heparinized (1 u heparin/ml) saline

Stockert 

Radiofrequency

Generator

Global Port Digital

ECG Connection Cable

Stockert

Global Port

Serial Computer 

Interface Cable D-type

Biosense Webster

CoolFlow Irrigation Pump

Biosense Webster

CoolFlow Irrigation 

Tubing Set

Blazer

™

 Open-Irrigated

Ablation Catheter

Model 691 Cable

EGM Connection 

Cable

Dispersive Indifferent Patch

Biosense Webster 

Stockert CoolFlow

Pump Interface Cable

CoolFlow is a trademark of Cordis Corporation.

The Blazer

™

 Open-Irrigated Ablation Catheter requires a generator, pump and tubing system 

able to deliver 1W to 50W of power and irrigation flow to the catheter cooling lumen of  
2ml/min during standby and 17-30 ml/min during RF delivery.

8

IntellaTip MiFi

™

 XP   

Temperature Ablation Catheter

System Set Up with Stockert EP-Shuttle RF Generator

Blazer

™

 Open-Irrigated  

Ablation Catheter

with Compatible Generator and Pump

7

Содержание Maestro 3000

Страница 1: ...CONNECTIONS GUIDE EP 305104 AA MAR2015 ...

Страница 2: ... Chilli II 4 1 Maestro 4000 4 2 Maestro 3000 5 Blazer Open Irrigated 5 1 Maestro 4000 5 2 Stockert 5 3 IBI 6 IntellaTip MiFi XP 6 1 Maestro 3000 set up 6 2 Maestro 4000 set up 6 3 Maestro 3000 4000 with EnSite Velocity 6 3 1 Basic EnSite Velocity 6 3 2 Advanced EnSite Velocity 6 4 Connection Guide IBI 18 6 5 Connection Guide Stockert 3 4 4 6 6 6 5 5 7 9 10 12 13 17 15 18 ...

Страница 3: ...ard 10 4 Operational Messages Card 11 MetriQ 11 1 Set up 11 2 Messages Card 21 27 33 35 37 39 41 43 CONNECTIONS GUIDE 8 Maestro 3000 guide 9 CircuCool Instructions 10 Maestro 4000 10 1 Controller Setup 10 2 Troubleshooting Guide 10 3 Diagnostic Messages Card 10 4 Operational Messages Card 11 MetriQ 11 1 Set up 11 2 Messages Card 20 26 32 34 36 38 40 42 ...

Страница 4: ...tly to gen CIRCUCOOL 352104 36 fixed 5 Dextrose MAESTRO 4K 681 50 1 Valley lab directly to gen CIRCUCOOL 352104 36 fixed 5 Dextrose STOCKERT MAESTRO 3K MAESTRO 4K 671 50 1 Valley lab directly to gen METRIQ 117 2 17 30 saline STOCKERT 691 50 1 39D82X0 COOLFLOW 116 or BW tubing set 2 17 30 saline IBI 1500T 100 339 ADAPTOR 691 50 1 Valley lab directly to gen COOL POINT SJ tubing set 2 17 30 saline Pr...

Страница 5: ...ure RF P ower Control Gener ator Ren RPM TM Indifferent Electrode Ind iffer ent Ele ctrode STD XP Ground Pad M004 354 0 Ground Pad M004 354 0 Cable Pod to Recorder M004 653S 0 Cable Pod to Catheter M004 651 0 or M004 613 0 Power Power Temp Aver age Maxim um Clear Control Panel Power Temp Impedance Impedance Time Counter Total Time Mem Mem Mem Mem Mem 1 2 3 4 5 Vie w Settings Temper ature RF P ower...

Страница 6: ...er Open Irrigated Ablation Catheter Blazer OI Pod to Catheter Cable M004 671 0 Ground Pad M004 354 0 Communication Cable M004 661 0 All cited trademarks are the property of their respective owners CAUTION The law restricts these devices to sales by or on the order of a physician Indications contraindications warnings and instructions for use can be found in the product labeling supplied with each ...

Страница 7: ...theter M004 651 0 or M004 613 0 Cable Pod to Recorder M004 653S 0 Cable Pod to Recorder M004 653S 0 Ground Pad M004 354 1 Ground Pad M004 354 1 Cable Pod to Catheter M004 651 0 or M004 613 0 Maestro 3000 Controller to Chilli II Cooled Ablation Catheter Cable Pod to Recorder M004 653S 0 Ground Pad M004 354 1 Cable Pod to Catheter M004 681 0 Tubing Kit M004 352104 0 Maestro 3000 Cardiac Ablation Sys...

Страница 8: ...Stockert Global Port Serial Computer Interface Cable D type Biosense Webster CoolFlow Irrigation Pump Biosense Webster CoolFlow Irrigation Tubing Set Blazer Open Irrigated Ablation Catheter Model 691 Cable EGM Connection Cable Dispersive Indifferent Patch Biosense Webster Stockert CoolFlow Pump Interface Cable CoolFlow is a trademark of Cordis Corporation The Blazer Open Irrigated Ablation Cathete...

Страница 9: ...egistrations PSST IC 6390 Printed in Germany by medicalvision 9 Irrigation Flow Recommendations The Stockert Radiofrequency Generator Operation Select Catheter Type THERMO COOL Confirm the CoolFlow Cut Off is set to 50 C generator default Set the initial power level to 15 20W Maximum power of 50W Power may be increased by 5 10W increments as needed Power W Irrigation Flow Rate ml min Mapping Stand...

Страница 10: ...ct Information Phone 49 0 7621 579 820 Email office medfact eu 10 BlazerTM Open Irrigated Ablation Catheter Connectivity to IBI generator MedFact Connect Adapter Cable Blazer OI Connector cable Blazer OI Catheter Model IBI Generator Model Catalog Number 100 339 M0046910 EPT9620K2 Large EPT9620 Standard EPT9620N4 Asymmetric 1500T11 Adaptor List Price 300 per box 150 each 2 nonsterile units per box ...

Страница 11: ...poles via the pins 1 2 3 and 4 to the Catheter Pin Connection Box Step 4 Connecting the Pod to the Filter Module a Connect the shrouded pin end 2mm shrouded pin of Reference Cable to the port marked Reference Cable on the Filter Module b Connect the 2 prong plug end of the Reference Cable to the Dispersive Indifferent Patch DIP port on the Pod c Connect the DIP to the 2 prong socket end of the Ref...

Страница 12: ...lling supplied with each device Information for the use only in countries with applicable health authority product registrations Information contained herein is for distribution outside the U S only Illustrations for information purposes not indicative of actual size or clinical outcome EP177405 AA AUG13 Printed in Germany by medicalvision Filter Module Reference Cable Catheter Cable IntellaTip Mi...

Страница 13: ... plug to the Pod b Connect the conventional bipoles via pins 1 2 3 and 4 to the Catheter Pin Connection Box Step 4 Connecting the Pod to the Filter Module a Connect the shrouded pin end 2mm shrouded pin of Reference Cable to the port marked Reference Cable on the Filter Module b Connect the 2 prong plug end of the Reference Cable to the Dispersive Indifferent Patch DIP port on the Pod c Connect th...

Страница 14: ...Cable plug into the green port marked Recording System on the Filter Module Connect the pins to the Catheter Pin Connection Box b Pin out the Mini Electrodes MEs D 2 and 3 Pin 4 is not used but can be plugged into any unused channel c Do Not Connect the Reference Cable M004 3636 0 when using the EnSite Velocity System Green Black Yellow Velocity EPT GenConnect Catheter Pin Connection Box Pannel on...

Страница 15: ...r in the Catheter Set Up Screen b Input waveforms D 2 2 3 and 3 D for the IntellaTip MiFi XP Ablation Catheter Mini Electrodes NAME ABL MIFI Electrodes 4 3 Type Ablation Diagnostic Diameter 8 Fr 2 67mm 8 Fr 2 67mm Distal Length 8 10mm 1mm Electrode Length 1 27mm 1mm Electrode Spacing 2 5 2 5 2 5 1 1 www bostonscientific eu 2014 Boston Scientific Corporation or its affiliates All rights reserved DI...

Страница 16: ...n Box b Pin out the Mini Electrodes MEs D 2 and 3 Pin 4 is not used but can be plugged into any unused channel c Do Not Connect the Reference Cable M004 3636 0 when using the EnSite Velocity System Step 3 Defining the IntellaTip MiFi XP Catheter Parameters a The IntellaTip MiFi Catheter should be defined as both an ablation ABL and diagnostic MIFI catheter in the Catheter Set Up Screen b Input wav...

Страница 17: ...nted in Germany by medicalvision www bostonscientific international com 2014 Boston Scientific Corporation or its affiliates All rights reserved DINEP2206EA IntellaTip MiFi XP Ablation Catheter Advanced Set Up with Ensite Velocity Cardiac Mapping System Enable visualization on the Mini Electrodes Before mapping create a model with the Conventional Bipoles Mapping with Mini Electrodes Point by Poin...

Страница 18: ... First 354 ValleyLab ground pad SJM IBI T1500 T9 SJM 1684 TH Adaptor cable 653S cable Must be ordered directly through SJM by the hospital Cannot be provided by BSC Second 354 ValleyLab ground pad 18 IntellaTip MiFi XP Temperature Ablation Catheter with SJM IBI T1500 T9 ...

Страница 19: ...ce Cable on the front of the Filter Module b Connect the 2 prong plug end of the Reference Cable to the Dispersive Indifferent Patch DIP c Connect the 2 prong plug end of the Reference Cable to 39D82X Reference cable required with Valley Lab DIP d Connect the 39D82X Reference cable to the front of the Generator with Blue plug which has the DIP symbol CATHETER PIN CONNECTION BOX Cable M004 653S 0 G...

Страница 20: ...s All rights reserved DINEP2234EA Catheter Model No Shaft Size Tip Size Curve Style Cable Model No M004 EPM4500 0 7F 2 33 mm 8F 2 66 mm 8mm straight Standard M004 620 0 M004 EPM4500K2 0 7F 2 33 mm 8F 2 66 mm 8mm straight Large M004 620 0 M004 EPM4500N4 0 7F 2 33 mm 8F 2 66 mm 8mm straight Asymmetric 4 M004 620 0 M004 EPM4790 0 7F 2 33 mm 8F 2 66 mm 10mm straight Standard M004 620 0 M004 EPM4790K2 ...

Страница 21: ...Maestro 3000 Cardiac Ablation System Set Up and Trouble Shooting Guide ...

Страница 22: ... to the recording system to display ablation parameters or to a computer if GUI software is installed 3 Optional If the optional footswitch is being used connect it to the back panel of the Controller 4 Connect recording system cable Model 653S to the back of the Pod 5 Connect the Pod cable to the Isolated Patient Connector socket of the Controller front panel 6 Receive the DIP electrode cable s f...

Страница 23: ...ed AC wall outlet designated Hospital Grade or Hospital Only 11 Optional If the optional Remote Control Unit is used connect the Remote Control cable to the back panel of the Controller 12 Optional If the Remote Control Unit is used connect the cable from the Controller to the rear panel of the Remote Control Unit 13 Turn on the Controller by pressing the power switch on the front panel of the Con...

Страница 24: ...impedance threshold of 50Ω for a standard catheter and 25Ω when using a high power catheter D02 High Impedance Displayed impedance above the Check application of impedance setting 150Ω 300Ω DIP electrode Check all connections Remove and inspect catheter D03 Limit Exceeded V 1 1 x Vmax or I 1 1 x Imax Restart System or P 1 2 x Pmax Contact Boston Scientific if error recurs D04 Temp Above Set Point ...

Страница 25: ...oston Scientific if error recurs D09 Replace Catheter Invalid catheter ID Replace Catheter Invalid ID D10 Check Remote There is a communications problem Restart system Check Control Panel between the Remote Control Unit connections If error recurs and the Controller disconnect Remote Control Unit and contact Boston Scientific M01 Limited Output TEMPERATURE MODE Maximum Check DIP electrode power is...

Страница 26: ...tem Foot Switch Optional Important Cable to be ordered from EPMedSystems 43 1684 0015 Cable Assembly EP WorkMate with RPM Combination Catheter Interface Module to Maestro 3000 Pod Power Cords Model Number Description Length M004 ITPWRCORD 0 Powercord for use in Italy 250 cm M004 SWPWRCORD 0 Powercord for use in Switzerland 250 cm M004 UKPWRCORD 0 Powercord for use in the UK 250 cm M004 3536010 20 ...

Страница 27: ...Chilli II Cooled Ablation Catheter CircuCool Fluid Circulation Pump Set Up and Trouble Shooting Guide ...

Страница 28: ... the bottom and connect and tighten the luers to the catheter luers 5 Using sterile technique connect the sterile cable to the catheter 6 Hand off the tubing set to someone in a non sterile field 7 Hand off the catheter cable to someone in a non sterile field 8 Connect catheter cable to the TTT Box model 2071 Turn on the TTT Box verify on light is illuminated 9 Insert the hard Peristaltic tubing i...

Страница 29: ... chamber and pulse dampener are in their slots 13 Using a syringe place 30cc of sterile normal saline 0 9 or D5W into the burette chamber 14 Check that the blue float seal is floating then turn on the pump 15 As the system circulates the fluid level will drop When it drops by 10cc add an additional 10cc of sterile normal saline 0 9 or D5W The unit is ready to use 16 Caution Perform system integrit...

Страница 30: ...erature is increasing Check tubing for leaks Check that tubing is not kinked or occluded Check catheter connection with tubing Check blue float seal in burette should be floating Check the TTT box model 2071 is turned on Check batteries of TTT box model 2071 may need to be replaced 2 each 9 volt The TTT box model 2071 may be faulty and may need to be replaced Check all cable connections The cathet...

Страница 31: ...that the catheter shaft is not kinked Blue float seal is stuck on bottom of burette chamber Turn pump off first Open the occlusion bed latch slightly this should release the float seal Check for leaks Ensure there is 10 cc of fluid in burette chamber when pump is on Knocking sound Note Pump makes a continuous audible churn this is normal Ensure tubing set is pulled taut inside the occlusion bed If...

Страница 32: ... 7F 4mm 2 33mm M004 EPT9031N4 0 Asymmetric N4 Standard 7F 4mm 2 33mm CircuCool Fluid Circulation Pump Model Number Description M004 8005 0 CircuCool Fluid Circulation Pump M00435 2104 0 CircuCool Tubing Set Accessories Model Number Description Accessories for use with Maestro 3000 Cardiac Ablation System M004 21000TC 0 Maestro 3000 Controller M004 21870T 0 Maestro 3000 Pod M004 681 0 Cable to conn...

Страница 33: ...ed connect the Remote Control cable to the Remote Connector 2 Connect a Hospital Grade power cord from the rear panel of the Controller to properly grounded AC wall outlet designated Hospital Grade or Hospital Only 3 Optional If the optional footswitch will be used con nect it to the Foot Switch Cable Connector 4 Optional If a MetriQ Pump is used connect the Pump cable to the Peristal tic Pump Con...

Страница 34: ...scientific com 2014 Boston Scientific Corporation or its affiliates All rights reserved DINEP2208EA 34 11 Attach Dispersive Pad electrodes to the Indifferent Electrode receptacles on the front of the Pod 14 To prepare a MetriQ Pump for use follow the in structions in the MetriQ Pump Setup Guide 12 Receive the 671catheter cable from the sterile field 15 Turn on the Controller by pressing the Main p...

Страница 35: ... BUT PUMP DOESN T SHOW AUTOMATIC Check to make sure an OI catheter is connected to the Pod and the Maestro display is not showing a message Tighten the connections at each end of the communications cable between the Maestro 4000 and MetriQ Pump Check Maestro for D12 error If Error is displayed press RF Power to clear If the previous actions don t resolve the problem use the Mains switches on the p...

Страница 36: ...new 671 cable Replace OI catheter Replace Pod RED LIGHT IN THE BUBBLE DETECTOR DOES NOT TURN FROM RED TO GREEN Gently stretch the tubing and push into slot on bubble detector Close and latch door to push tubing into place Open door again to check that LEDs have turned green Check the tubing for blemishes where it passes through bubble detectors Replace tubing if it has blemishes PUMP IS UNRESPONSI...

Страница 37: ...hen press the RF Power Button Some diagnostic codes will require that the error be cleared prior to resolving the issue eg Low High Impedance in order to monitor the real time display Below is a sampling of codes and corrective actions All codes and complete operating instructions are in the Maestro Operator s Manual Alphanumeric Display D01 LOW IMPEDANCE D02 HIGH IMPEDANCE The Voltage Current or ...

Страница 38: ...Test is complete and Finding cont D06 TEMP OUT OF RANGE 15C 95C D07 TEMPERATURE TOO HIGH D08 CHECK POD Cause Action Cause Action Cont Catheter is displayed on the screen connect the catheter extension cable to the POD The Maestro 4000 should then return to a Ready Standby state displaying both real time tempera ture and impedance If this does not resolve the issue replace the POD Generator doesn t...

Страница 39: ...e with new components catheter extension cable DIP electrodes POD if available catheter This message indicates a normal condition It is displayed during an open irrigated ablation sequence while the pump delivers fluid at the ablation flow rate during pre RF and post RF delay Wait for MetriQ Pump to complete pre RF delay or post RF delay or adjust the delay duration on MetriQ Pump as appropriate T...

Страница 40: ... OI catheter but the temperature setting has not been changed from the default Adjust temperature setting to an appropriate value before requesting RF delivery Communication has been interrupted between the Maestro and Pump while the Maestro is in STANDBY mode When the Maestro 4000 and MetriQ are con nected and have an OI catheter attached they oper ate in Automatic mode In this state the pump wil...

Страница 41: ... MetriQ Pump to Maestro 4000 cable Generator to Pump or Remote 5 Note Select one and press Enter Starting a New Case resets dispensed and infused fluid volumes to 0ml Continuing Previous Case retains previous volumes 8 Close the door and wait for the MetriQ Pump to finish calibration Start New Case YES Continue Previous Case NO Automatic Mode 2 17 30 2000 mL remaining PLEASE WAIT IN PROGRESS CALIB...

Страница 42: ...scientific com 2014 Boston Scientific Corporation or its affiliates All rights reserved DINEP2213EA Select the size of the saline bag 500mL 1000mL 1500mL or 2000mL Press to open and close menu and to abort changes Press to select item and accept changes Move through menu and adjust settings Select the point at which the Low Fluid warning will be triggered OFF 0 100 200 300 400 500 mL Select the vo...

Страница 43: ...ng flow Do not try to open the door during flow If open close and latch the door Press the CLEAR MESSAGE button Press the STANDBY FLOW but ton to resume pump operation Displayed if the RF generator detects the catheter is in the patient and the pump is not running in STANDBY or ablation flow Remove catheter from patient and press the PURGE button if appropriate Press the STANDBY FLOW button Press ...

Страница 44: ...e pump and Maestro 4000 are connected but an OI cath eter is not attached to the Maestro 4000 If you intend to operate the pump in automatic mode but the pump shows Manual Mode first check to make sure the OI catheter and pod are securely connected Next check the cable as described under GENERATOR DISCONNECTED The fluid remaining in the saline bag is below the menu setting for Low Fluid Warning Ch...

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