Medrad AngioJet Ultra Operation Manual
System Console
Operations Manual
CONSOLE OPERATIONS MANUAL
TABLE OF CONTENTS
The Thrombectomy Set
2. INDICATIONS AND USAGE
3. CONTRAINDICATIONS
4. WARNINGS and PRECAUTIONS
5. ADVERSE EVENTS
6. CONSOLE SPECIFICATIONS
7. CLINICIAN USE INFORMATION
7.1 Prepare Console
7.2 Load Pump
7.3 Prime the Catheter
7.4 Ultra System Dismantling
7.5 Alarms and Error Messages
7.6 Ultra System Errors
7.7 Maintenance
1. DEVICE DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
The Console
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7.8 Glossary
7.9 Symbols
8. HOW SUPPLIED
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CAUTION: Federal (USA) Law restricts this device to sale by or on the order of a physician.
1. DEVICE
DESCRIPTION
This manual provides instructions for operating the AngioJet® Ultra
Thrombectomy System, with specific focus on the AngioJet Ultra Console.
The AngioJet Ultra System consists of the following components:
A. The AngioJet Ultra Console (Console)
Control Panel
Drawer
Open/Close
Button
Pump Drawer
Roller Pump
Foot Pedal Bracket
Main Power Circuit
Breaker Switch
Power Cord
Foot Pedal
Front View
Figure 1 - AngioJet Ultra Console
Back View
The Console is a multiple-use device that controls the Thrombectomy Set.
It drives the pump, regulates fluid inflow and outflow, provides the
operator with Ultra System set-up prompts, total infused 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, disposable Thrombectomy Set includes:
• Pump
• Catheter
• Saline delivery and
waste tubing
• Collection bag
Delivery and
waste tubing
Pump
Collection
bag
2
Catheter
Figure 2 - Thrombectomy Set
A bag of sterile, heparinized saline (not included) supplies the pump with
saline through the saline delivery tubing. The pump pressurizes the saline.
The Thrombectomy Set uses this pressurized, high-velocity saline to create
a low-pressure zone at the catheter tip. This allows the catheter to break up
and remove thrombus. The waste tubing transports the thrombus debris
from the catheter to the collection bag for ultimate disposal.
2. INDICATIONS AND USAGE
3. CONTRAINDICATIONS
4. WARNINGS AND
PRECAUTIONS
The Console is intended for use only in conjunction with an AngioJet Ultra
Thrombectomy Set. Refer to the individual Thrombectomy Set Information
for Use manual for specific clinical applications.
Refer to the individual Thrombectomy Set Information for Use manual for
specific contraindications.
• The AngioJet Ultra System should be used only by operators who have
received appropriate training on its installation and use.
• Use the AngioJet Ultra Console only with an AngioJet Ultra
Thrombectomy Set. This Console will not operate with a previous
model pump set and catheter.
• Do not attempt to bypass 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 solution to avoid thrombus formation and maintain
lumen patency. Reprime the catheter by submerging the tip in sterile,
heparinized solution and operating it for at least 20 seconds before
reintroduction to the patient.
• Physician discretion with regard to the use of heparin is advised.
• Refer to the individual AngioJet Ultra Thrombectomy Set
for Use manual for specific warnings and precautions.
• Do not move the collection bag during catheter operation as this may
cause a collection bag error.
• Monitor thrombotic debris/fluid flow exiting the catheter through
the waste tubing during use. If blood is not visible during console
activation, the catheter may be occlusive within the vessel or the
outflow lumen may be blocked.
• Ensure adequate patient anticoagulation to prevent thrombus
formation in outflow lumen.
• Refer to individual Thrombectomy Set
specific instructions regarding heparinization of the Thrombectomy Set.
Instructions for Use manual for
Information
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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.
5. ADVERSE EVENTS
Refer to the individual Thrombectomy Set Information for Use manual for
specific observed and/or potential adverse events.
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