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• The Console contains no user-serviceable parts. Refer service to

qualified personnel.

• Removal of outer covers may result in electrical shock.
• This device may cause electromagnetic interference with other devices

when in use. Do not place Console near sensitive equipment when

operating.

• Equipment not suitable for use in the presence of flammable anesthetic

mixture with air or with oxygen or nitrous oxide.

Refer to the individual Thrombectomy Set

Information for Use

manual for

specific observed and/or potential adverse events.

5. ADVERSE EVENTS

Содержание AngioJet Ultra

Страница 1: ...System Console Operations Manual...

Страница 2: ...S and PRECAUTIONS 3 5 ADVERSE EVENTS 4 6 CONSOLE SPECIFICATIONS 5 7 CLINICIAN USE INFORMATION 6 7 1 Prepare Console 7 7 2 Load Pump 8 7 3 Prime the Catheter 9 7 4 Ultra System Dismantling 11 7 5 Alarm...

Страница 3: ...saline volume and Ultra System malfunction warnings The Console is activated by pressing a foot pedal B The AngioJet Ultra Thrombectomy Set Thrombectomy Set Several models available The single use dis...

Страница 4: ...any of the Console safety features If the catheter is removed from the patient and or is inoperative the waste tubing lumen guide catheter and sheath should be flushed with sterile heparinized solutio...

Страница 5: ...netic interference with other devices when in use Do not place Console near sensitive equipment when operating Equipment not suitable for use in the presence of flammable anesthetic mixture with air o...

Страница 6: ...n IPX8 against ingress of liquid Mode of electrical operation Continuous Transport storage temperature 25 C to 57 C Transport storage humidity 10 to 100 Transport storage atmospheric 500hPa to 1060hPa...

Страница 7: ...ctions on what to do if error messages are displayed Figure 3 Control Panel with Labels Time Display During catheter priming the time display counts down to zero During the procedure the time display...

Страница 8: ...NOTE The Ultra System is designed to be interactive The status panel will provide prompts to guide the technician through set up as well as provide error resolution when necessary Preparation of the...

Страница 9: ...Set to the nonsterile technician for installation into the Console Figure 6 NOTE If a clamp is used to keep the catheter in the sterile field ensure that the clamp does not deform the tubing 2 Nonste...

Страница 10: ...pedal within easy access of the physician Choose a location that will minimize accidental activation The status panel displays PRIME indicating that the initial pump prime was successful Figure 10 Cat...

Страница 11: ...isplays READY and green icon is illuminated Figure 14 The AngioJet Ultra System is now ready to use During operation the infused volume will be displayed on the status panel the green icon remains lit...

Страница 12: ...Press POWER button to deactivate control panel Pump drawer will automatically retract when powering down 5 Unplug the power cord from the wall outlet and coil the cord on the hooks in the power cord a...

Страница 13: ...Figure 17 A system failure will result in a system error wrench icon lights red shown in Figure 18 Turn off the power then restart before contacting MEDRAD Technical Service for further instructions...

Страница 14: ...ing the operator to install the pump into the Console Over Pressure Alarm A recoverable condition occurring when an abnormally high pressure has been detected Replacement of the Thrombectomy Set may b...

Страница 15: ...ator proof type CF equipment 8 IPX 1 Protection against dripping water 9 IPX 8 Protection against the effects of permanent immersion in water 10 Alternating current 11 Equipotentiality 12 Fuse 13 Foot...

Страница 16: ...nd or saphenous vein grafts See Information For Use manuals for specific and complete prescribing information 2006 2009 MEDRAD INC All rights reserved All information drawings and ideas herein constit...