AngioJet Ultra 5000A Console Operators Manual

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

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TABLE OF CONTENTS DEVICE DESCRIPTION... 4 Contents... 4 AngioJet™ Ultra 5000A Console (Console or AngioJet Ultra Console)... 4 Figure 1. AngioJet Ultra Console... 4 AngioJet Thrombectomy Set (Thrombectomy Set)... 5 Figure 2. Thrombectomy Set... 5 INTENDED USE/INDICATIONS FOR USE... 5 CONTRAINDICATIONS... 5 WARNINGS... 5 PRECAUTIONS... 5 Disposal... 5 POTENTIAL ADVERSE EFFECTS... 5 HOW SUPPLIED... 5 HANDLING AND STORAGE... 5 Operating Environment... 5 Transport Environment... 5 Storage Environment... 5 USING THE ANGIOJET ULTRA CONSOLE... 6 Clinician Use Information... 6 Prepare Console... 6 Figure 3... 6 Figure 4. Reference Only... 6 Load Pump... 7 Figure 5... 7 Figure 6... 7 Figure 7... 7 Figure 9. Reference Only... 8 Prime the Catheter... 8 Figure 10. Reference Only... 8 Figure 11... 8 Figure 12... 8 Figure 13. Reference Only... 8 Figure 14. Reference Only... 8 AngioJet System Dismantling... 9 Figure 15... 9 Figure 16... 9 ANGIOJET ULTRA CONSOLE SYMBOL TRANSLATION KEY... 9 MAINTENANCE, TROUBLESHOOTING AND SERVICE... 10 Alarms and Error Messages... 10 Figure 17. Example... 10 Figure 18. Example... 10 Console Errors... 10 Figure 19. Example... 10 GLOSSARY OF TERMS... 10 SPECIFICATIONS... 11 ELECTRONIC AND ELECTROMAGNETIC GUIDANCE... 11 Table 1. Guidance and manufacturer’s declaration - electromagnetic emissions... 11 Table 2. Guidance and manufacturer’s declaration - electromagnetic immunity... 12 WARRANTY... 13

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Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

Figure 8... 7

AngioJet™ Ultra 5000A Console

Bag Hook Control Panel

Thrombectomy System Console ONLY

Drawer Open/Close Button

Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. The AngioJet Ultra Console is intended for use only in conjunction with an AngioJet Thrombectomy Set. Refer to the individual Thrombectomy Set Directions for Use manual for specific clinical applications. DEVICE DESCRIPTION

The AngioJet Thrombectomy System allows for percutaneous removal of thrombus located in peripheral arteries and veins, saphenous vein bypass grafts, native coronary arteries, and native or synthetic AV access conduits. Thrombectomy is accomplished using high-pressure saline jets contained in the catheter shaft. The saline jets create a low-pressure effect to draw thrombus into the catheter, fragment the thrombus, and remove the thrombus from the treatment site. The system consists of a single use Thrombectomy Set (several models available) and a free standing mobile Console. Contents One (1) Console One (1) Operator’s Manual One (1) Foot switch with cord One (1) Power cord

Roller Pump Pump Drawer

AngioJet Ultra 5000A Console (Console or AngioJet Ultra Console)

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

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 AngioJet System set-up prompts, total infused saline volume, and AngioJet System malfunction information. The Console is activated by pressing a foot switch.

Handle

Foot Switch Bracket Main Power Circuit Breaker Switch Power Cord

Foot Switch Figure 1. AngioJet Ultra Console

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AngioJet™ Thrombectomy Set (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 lowpressure 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.

•

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

•

Removal of outer covers may result in electrical shock.

PRECAUTIONS

• • •

Piston Head

•

Pump

• Waste Tubing

• •

Catheter

• • Collection Bag

The AngioJet 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 Thrombectomy Set. The AngioJet System requires special precautions regarding electromagnetic emissions and immunity and needs to be installed and put into service according to the information included in the Electronic and Electromagnetic Guidance Section. This device may cause electromagnetic interference with other devices when in use. Do not place the AngioJet System near sensitive equipment when operating. Console bag hooks are intended for physician specified fluid and/or saline bags only. Hanging other objects or applying additional weight to the bag hooks may cause damage. When drawer is extended from Console, avoid knocking or leaning on the drawer. This may damage the device. Do not move the collection bag during catheter operation as this may cause a waste tubing error. Do not reposition or push the Console from any point other than the handle designed for that purpose. A condition of overbalance or tipping may ensue. In the event the foot switch is stuck in the “on” position (inadvertent activation), press the POWER button or pull the power cord from the wall outlet to deactivate the system. Contact Boston Scientific Customer Service.

Disposal

The user should follow local and national regulations for disposal of electronics when disposing of this unit. Contact Boston Scientific Customer Service for product returns. POTENTIAL ADVERSE EFFECTS

Refer to the individual Thrombectomy Set Directions for Use manual for specific observed and/or potential adverse events.

Figure 2. Thrombectomy Set INTENDED USE/INDICATIONS FOR USE

HOW SUPPLIED

The AngioJet Ultra Console is intended for use only in conjunction with an AngioJet Thrombectomy Set. Refer to the individual Thrombectomy Set Directions for Use manual for specific clinical applications.

Do not use if labeling is incomplete or illegible.

CONTRAINDICATIONS

Refer to the individual Thrombectomy Set Directions for Use manual for specific contraindications.

HANDLING AND STORAGE Operating Environment

Temperature: 10 °C to 40 °C (50 °F to 104 °F) Relative Humidity: 30% to 75% (noncondensing) Atmospheric Pressure: 700 hPa to 1060 hPa

WARNINGS

• • • • • •

•

•

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

This product is supplied non-sterile and is intended for multiple use. Do not use if package is opened or damaged.

Equipment not suitable for use in the presence of flammable anesthetic mixture with air or with oxygen or nitrous oxide. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Refer to the individual Thrombectomy Set Directions for Use manual for specific warnings and precautions.

Transport Environment

Temperature: -25 °C to 55 °C (-13 °F to 131 °F) Relative Humidity: 10% to 95% (noncondensing) Atmospheric Pressure: 500 hPa to 1060 hPa

Refer to the individual Thrombectomy Set Directions for Use manual for specific instructions regarding heparinization of the Thrombectomy Set. Do not attempt to bypass any of the Console safety features. The AngioJet System should not be used adjacent to or stacked with other equipment, and if adjacent or stacked use is necessary, the Console should be observed to verify normal operation in the configuration in which it will be used. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in) to any part of the AngioJet System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Use of accessories, transducers and cables other than those specified or provided by Boston Scientific could result in increased electromagnetic emissions or decreased electromagnetic immunity of the AngioJet System and result in improper operation.

Storage Environment

Temperature: -25 °C to 55 °C (-13 °F to 131 °F) Relative Humidity: 10% to 95% (noncondensing) Atmospheric Pressure: 500 hPa to 1060 hPa

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USING THE ANGIOJET™ ULTRA CONSOLE

Clinician Use Information

Time Display

A thorough understanding of the AngioJet System components is required for proper operation. Read this manual and the Directions for Use supplied with the Thrombectomy Set before attempting to use any of the components of the AngioJet System.

Counter Reset Button

Improper AngioJet System preparation or abnormal component operation will halt Console operation and troubleshooting steps or error messages may occur. If operation halts, refer to Alarms and Error Messages in the Maintenance, Troubleshooting and Service Section.

Icons

Prepare Console Status Panel

Note: The AngioJet System is designed to be interactive. The status panel will provide prompts to guide the technician through set-up as well as provide troubleshooting steps when necessary.

Scroll Buttons

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

Alarm Reset Button

Power Button

Preparation of the AngioJet System requires the assistance of a sterile and a nonsterile technician. The catheter is used within the defined sterile field; the Console and pump are operated outside the sterile field. The following directions are for the nonsterile technician except where otherwise noted.

Catheter Button

Time Display

During catheter priming, the time display counts down to zero. During the procedure, the time display counts up from zero.

Icons

Display the progress of set-up and operation steps and also indicate when an alarm or error has occurred. Action Required

Prime Catheter

Install Pump

System Ready

Connect Saline

Contact Boston Scientific Customer Service

Status Panel

Provides instructions, procedure status, and alarm resolution strategies.

Power Button

Press to activate or deactivate the control panel.

Alarm Reset Button

1.

Main Power Circuit Breaker Switch

Figure 3. 2. Heparinize a bag of sterile, room-temperature saline at a suggested rate of 5000 units per liter of saline and mix contents (a 1.0 liter bag is recommended, but is not included with the AngioJet System). Hang the saline bag on the bag hook at the top of the Console. Precaution: Console bag hooks are intended for physician specified fluid and/ or saline bags only. Hanging other objects or applying additional weight to the bag hooks may cause damage.

Press to continue operation after following on-screen troubleshooting steps.

Catheter Button

Displays catheter model installed in the Console. Press this button to see a 3-second display of catheter model. Additional functions allowed based on catheter model (refer to individual Thrombectomy Set Directions for Use).

Scroll Buttons

These buttons are active only for selection or when there is more text to be displayed.

Counter Reset Button

Press this button to return the time display and infused volume to zero.

Plug in the Console and ensure the main power circuit breaker switch is turned ON (Figure 3).

3.

Press the POWER button on the control panel.

All indicators on the control panel will illuminate. The status panel will display ANGIOJET ULTRA while the Console performs a self-test. The drawer will open, indicating a successful self-test. The status panel will display the next steps (Figure 4).

NOTE: You cannot use the Counter Reset Button to override the time needed for priming the catheter.

Figure 4. Reference Only

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Precaution: When drawer is extended from Console, avoid knocking or leaning on the drawer. This may damage the device. Load Pump 1.

Sterile technician: Remove the catheter and sufficient tubing for ease of use from the sterile package and inspect for damage. Hand the tray with the rest of the Thrombectomy Set to the nonsterile technician for installation into the Console (Figure 5).

Saline Delivery Tubing Roller Pump Waste Tubing

Figure 7. 4. 5.

Remove the cap from the Thrombectomy Set bag spike and insert the spike into the saline bag. Push the drawer button to close the Console drawer (Figure 8).

Figure 8. The Console will load the pump and scan the bar code located on the pump. After the Console successfully identifies the catheter, the status panel will display the model of catheter in use (Figure 9).

Figure 6. 3.

Ensure that the waste tubing aligns with the roller pump (Figure 7).

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Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

Figure 5. 2. Nonsterile technician: Remove the rest of the Thrombectomy Set from the tray by gripping the pump (not the piston head) and insert the pump into the Console (Figure 6).

Catheter priming time is determined by the catheter model and is automatically set by the Console. 1.

Prime the catheter by completely submerging the tip in heparinized saline and pressing the foot switch (Figures 11 and 12).

Figure 9. Reference Only The Console will automatically pull saline into the pump. 6. Place the foot switch within easy access of the physician. Choose a location that will minimize accidental activation. Prime the Catheter

The status panel displays PRIME indicating that the initial pump prime was successful. The time display shows the time required to complete the priming sequence (Figure 10).

Figure 11. 2.

Figure 12.

Continue priming until the time display reaches zero seconds.

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

The status panel displays PRIME COMPLETE (Figure 13).

Figure 10. Reference Only

Figure 13. Reference Only 3. Confirm AngioJet™ System set-up is successfully completed by removing foot from foot switch. The status panel displays READY and green icon is illuminated (Figure 14).

Figure 14. Reference Only

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The AngioJet™ System is now ready to use. During operation, the infused volume will be displayed on the status panel, the green icon remains lit, and the time display will keep track of the total time that the foot switch is activated.

Bar Code Window

Note: Once the foot switch is released, the system will continue to complete the current pump stroke. Caution: Do not move the collection bag during catheter operation as this may cause a waste tubing error. Precaution: In the event the foot switch is stuck in the “on” position (inadvertent activation), press the POWER button or pull the power cord from the wall outlet to deactivate the system. Contact Boston Scientific Customer Service.

AngioJet System Dismantling

Follow proper precautions for the handling of infectious waste. Reuse of Thrombectomy Set is prohibited due to risk of contamination by blood waste products. After use, disassemble the components as follows: 1. Push the drawer button to open the drawer. 2. 3.

Carefully remove Thrombectomy Set from Console. Unhook the saline supply and collection bag and dispose together with the Thrombectomy Set.

4.

Press POWER button to deactivate control panel. Pump drawer will automatically retract when powering down. Wait for drawer to fully retract, then unplug the power cord from the wall outlet. Coil the foot switch cord around the hook and foot switch bracket (5 turns) and place the foot switch into the bracket. Coil the power cord around the hook and bracket for proper storage (Figure 15).

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Figure 16. ANGIOJET ULTRA CONSOLE SYMBOL TRANSLATION KEY Catalog Number

REF

Follow instructions for use

Contents

EC

REP

EU Authorized Representative

LOT

Lot

Recyclable Package

AUS

Australian Sponsor Address

ARG

Argentina Local Contact

BRA

Brazil Local Contact

Do not use if package is damaged. 00 % 00 %

Humidity limitation

Defibrillation-Proof Type CF Applied Part Figure 15. 6. Clean the Console surfaces thoroughly with a standard, mild germicidal cleaning agent. Do not clean with harsh detergent or chemical agents.

CAUTION Attention: Consult ACCOMPANYING DOCUMENTS.

Note: Check bar code window for saline build-up, clean with long cotton-tipped swab and water, if necessary (Figure 16).

Separate Collection

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Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

Legal Manufacturer

ANGIOJET™ ULTRA CONSOLE SYMBOL TRANSLATION KEY Equipotentiality

Fuse

Foot Switch

Alternating Current 0000 °C 0000 °C

Temperature limitation Figure 17. Example The Console allows multiple attempts to correct most alarm conditions. If the alarm persists, the Console may prompt the user to replace the Thrombectomy Set (Figure 18).

Date of Manufacture

SN NON STERILE

Serial Number

Non-Sterile

ON (power: connection to mains)

OFF (power: disconnection to mains)

Standby

Eject (open/close drawer) Figure 18. Example Console Errors

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

Pushing Prohibited

A Console failure will result in a system error (wrench icon lights red, shown in Figure 19). Turn off the power, then restart before contacting Boston Scientific Customer Service for further instructions. Make note of each system error title and number to report to Boston Scientific Customer Service.

Non-Ionizing Electromagnetic Radiation

E352516

MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES60601-1:A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, CSA CAN/CSA-C22.2 No. 60601-1:14; UL 60601-1, CAN/CSA C22.2 No. 601.1. E249838 21KV E352516

MAINTENANCE, TROUBLESHOOTING AND SERVICE

Refer to your Limited Warranty and Disclaimer and/or Certificate of Extended Warranty, if applicable, for information on servicing the AngioJet Ultra Console. Boston Scientific recommends annual inspection and calibration. There are no user serviceable parts inside the Console. The Console cabinet panels should only be opened by trained service personnel. Alarms and Error Messages

Alarms and error messages indicate improper AngioJet System preparation or abnormal component operation. The Console status panel will display alarm resolution messages and prompts (Example shown in Figure 17). In most instances, alarms will either adjust themselves or prompt the user to repeat a step. Follow the prompts displayed on the status panel for alarm resolution.

Figure 19. Example GLOSSARY OF TERMS

Alarm: A recoverable or nonrecoverable fault occurring when one of the Console safety sensors responds to abnormal operation of a component. Check Catheter Alarm: A recoverable condition occurring when an abnormally high pressure has been detected. Replacement of the Thrombectomy Set may be necessary.

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Check Saline Supply Alarm: A recoverable condition occurring when an abnormally low pressure has been detected. Replacement of the Thrombectomy Set may be necessary.

ELECTRONIC AND ELECTROMAGNETIC GUIDANCE

Table 1. Guidance and manufacturer’s declaration – electromagnetic emissions

The AngioJet System is intended for use in the electromagnetic environment specified below. The customer or the user of the AngioJet System should assure that it is used in such an environment.

Collection Bag: The bag which collects the extracted thrombus being removed by the catheter. The bag hangs on the Console drawer. Control Panel: The operator interface on the upper front of the Console. Error: A nonrecoverable fault which has occurred because of Thrombectomy Set or Console malfunction. Saline Delivery Tubing: The tubing which transports saline from the saline bag to the pump.

Emissions Test

Self-Test: An operation performed by the Console to examine the fidelity and the state of its circuit paths and sensors. An appropriate indicator will be illuminated if any abnormality is detected. Thrombectomy Set: The disposable component of the AngioJet™ Thrombectomy System which delivers pressurized saline and removes debris. It consists of the saline bag spike, saline delivery tubing, pump, catheter, waste tubing, and collection bag.

RF emissions CISPR 11

Group 1

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations flicker/ emissions IEC 61000-3-3

Complies

Waste Tubing: The tubing which is inserted in the roller pump and transports the extracted thrombus from the effluent tubing to the collection bag. SPECIFICATIONS

5000A

Dimensions, D x W x H

25 in x 16.5 in x 54 in (63.5 cm x 42 cm x 137 cm)

Weight

140 lbs (63.5 kg)

Voltage requirements

100/120/220/240 VAC

Frequency requirements

50/60 Hz

Power requirements

900 VA

Logic power backup outage

60 seconds for conditions of power loss

Equipment class

Class 1

Degree of protection against electrical shock

Defibrillation-Proof Type CF Applied Part

Enclosure protection against ingress of liquid

IPX 1

Foot switch protection against ingress of liquid

IPX 8

Mode of (electrical) operation

Continuous

Transport temperature

-25 °C to 55 °C (-13 °F to 131 °F)

Transport relative humidity

10% to 95% (noncondensing)

Transport atmospheric pressure

500 hPa to 1060 hPa

Storage temperature

-25 °C to 55 °C (-13 °F to 131 °F)

Storage relative humidity

10% to 95% (noncondensing)

Storage atmospheric pressure

500 hPa to 1060 hPa

Operation temperature

10 °C to 40 °C (50 °F to 104 °F)

Operation humidity

30% to 75% (noncondensing)

Operation atmospheric pressure

700 hPa to 1060 hPa

Pollution

No greater than degree 2

Installation/Overvoltage

No greater than category 2

Fuse

100/120V, T10AL, 250V, 5 mm x 20 mm 220/240V, T6.3AL, 250V, 5 mm x 20 mm

Cables

Electromagnetic Environment – Guidance The AngioJet System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The AngioJet System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

NOTE: The emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

Model Number

Compliance

AC adapter cable Maximum Cord Length 10 ft (3.05 m) Foot Switch Maximum Cord Length 15 ft (4.57 m)

The AngioJet Ultra Console is UL LLC Classified to ANSI/AAMI ES60601-1:A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, CSA CAN/CSA-C22.2 No. 60601-1:14; UL 60601-1, CAN/CSA C22.2 No. 601.1. Note: If it becomes necessary to replace the fuse, replace fuse with the type and rating specified. Failure to do so may result in device damage or risk of fire.

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Table 2. Guidance and manufacturer’s declaration - electromagnetic immunity The AngioJet™ System is intended for use in the electromagnetic environment specified below. The customer or the user of the AngioJet System should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

Electromagnetic Environment - Guidance

Electrostatic Discharge (ESD) IEC 61000-4-2

± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

± 2 kV, ± 4 kV, ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Electrical fast transient / burst IEC 61000-4-4

± 2 kV input AC power ± 1 kV SIP/SOP 100 kHz repetition frequency

± 2 kV input AC power ± 1 kV SIP/SOP 100 kHz repetition frequency

Mains power quality should be that of a typical commercial or hospital environment.

Surge: Line-to-line IEC 61000-4-5

± 0.5 kV, ± 1 kV input AC power

± 0.5 kV, ± 1 kV input AC power

Surge: Line-to-ground IEC 61000-4-5

± 0.5 kV, ± 1 kV, ± 2 kV input AC power

± 0.5 kV, ± 1 kV, ± 2 kV input AC power

Mains power quality should be that of a typical commercial or hospital environment.

0% UT for 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0% UT for 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0% UT for 1 cycle and 70% UT for 25/30 cycles Single phase: at 0°

0% UT for 1 cycle and 70% UT for 25 cycles (50 Hz) and 30 cycles (60 Hz) Single phase: at 0°

Voltage interruptions IEC 61000-4-11

0% UT for 250/300 cycles

0% UT for 250 cycles (50 Hz) and 300 cycles (60 Hz)

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

30 A/m 50 Hz or 60 Hz

30 A/m 50 Hz and 60 Hz

3 V between 0.15 MHz – 80 MHz

3 V between 0.15 MHz – 80 MHz

Conducted disturbances induced by RF fields IEC 61000-4-6

6 V in ISM bands between 0.15 MHz and 80 MHz

6 V in ISM bands between 0.15 MHz and 80 MHz

At 80% AM with 1 kHz modulation frequency

At 80% AM with 1 kHz modulation frequency

Radiated RF EM fields IEC 61000-4-3

3 V/m between 80 MHz – 2.7 GHz At 80% AM with 1 kHz modulation frequency

3 V/m between 80 MHz – 2.7 GHz At 80% AM with 1 kHz modulation frequency

380 MHz - 390 MHz: 27 V/m 430 MHz - 470 MHz: 28 V/m 704 MHz - 787 MHz: 9 V/m 800 MHz - 960 MHz: 28 V/m 1700 MHz - 1990 MHz: 28 V/m 2400 MHz - 2570 MHz: 28 V/m 5100 MHz - 5800 MHz: 9 V/m

385 MHz: 27 V/m 450 MHz: 28 V/m 710 MHz: 9 V/m 745 MHz: 9 V/m 780 MHz: 9 V/m 810 MHz: 28 V/m 870 MHz: 28 V/m 930 MHz: 28 V/m 1720 MHz: 28 V/m 1845 MHz: 28 V/m 1970 MHz: 28 V/m 2450 MHz: 28 V/m 5240 MHz: 9 V/m 5500 MHz: 9 V/m 5785 MHz: 9 V/m

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

Voltage dips IEC 61000-4-11

Proximity fields from RF wireless communications equipment IEC 61000-4-3

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Console requires continued operation during power mains interruptions, it is recommended that the Console be powered from an uninterruptible power supply or a battery. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1: UT is the a.c. mains voltage prior to application of the test level. NOTE 2: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 3: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. NOTE 4: The AngioJet System is intended for use in hospitals and outpatient facilities only. The equipment has not been assessed for use near high frequency surgical equipment and interference may occur. If degradation of performance is observed, move the equipment away from the high frequency surgical equipment or contact Boston Scientific for assistance. For additional corrective actions, refer to "Maintenance, Troubleshooting and Service" Section. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the AngioJet System is used exceeds the applicable RF compliance level above, the AngioJet System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the AngioJet System. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. a

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WARRANTY

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or fitness for a particular purpose. Handling, storage, cleaning and sterilization of this instrument as well as other factors relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond BSC’s control directly affect the instrument and the results obtained from its use. BSC’s obligation under this warranty is limited to the repair or replacement of this instrument and BSC shall not be liable for any incidental or consequential loss, damage or expense directly or indirectly arising from the use of this instrument. BSC neither assumes, nor authorizes any other person to assume for it, any other or additional liability or responsibility in connection with this instrument. BSC assumes no liability with respect to instruments reused, reprocessed or resterilized and makes no warranties, express or implied, including but not limited to merchantability or fitness for a particular purpose, with respect to such instruments.

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Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

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BRA

Brazil Local Contact

Para informações de contato da Boston Scientific do Brasil Ltda, por favor, acesse o link www.bostonscientific.com/bra

Boston Scientific (Master Brand, Spiral Bound Manual Template, 8.5in x 11in Global, 92238518A), MB, AngioJet Ultra Sys, Oper Manual, en, 50779353-01A

EC

REP

EU Authorized Representative

Boston Scientific Limited Ballybrit Business Park Galway IRELAND

AUS

Australian Sponsor Address

Boston Scientific (Australia) Pty Ltd PO Box 332 BOTANY NSW 1455 Australia Free Phone 1800 676 133 Free Fax 1800 836 666

ARG

Argentina Local Contact

Para obtener información de contacto de Boston Scientific Argentina SA, por favor, acceda al link www.bostonscientific.com/arg

Legal Manufacturer Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 USA USA Customer Service 888-272-1001

Do not use if package is damaged. Recyclable Package

0086 © 2019 Boston Scientific Corporation or its affiliates. All rights reserved.

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2019-02

50779353-01