Boston Scientific AnjioJet Ultra 5000A User manual

Instrucciones de uso 15
Mode d’emploi 27
Gebrauchsanweisung 39
Istruzioni per l’uso 51
Gebruiksaanwijzing 63
Instruções de Utilização 75
Brugsanvisning 87
Οδηγίες χρήσης 99
Instruções de uso 111
Bruksanvisning 123
Használati útmutató 135
Návod k použití 147
Sposób użycia 159
Bruksanvisning 171
사용 지침 183
Kullanma Talimatları 195
Käyttöohjeet 207
Instrucțiuni de utilizare 219
Руководство по применению 231
Návod na použitie 243
Boston Scientific (Master Brand DFUTemplate 8.5in x 11in Global, 90106042 RevAN), MB, AngioJet Ultra System Operators Manual, Global, 91024738-01C
Black (K) ∆E ≤5.0
AngioJet™Ultra 5000A Console
Operator’s Manual
Directions for Use 3

Black (K) ∆E ≤5.0
Boston Scientific (Master Brand DFUTemplate 8.5in x 11in Global, 90106042 RevAN), MB, AngioJet Ultra System Operators Manual, Global, 91024738-01C
Black (K) ∆E ≤5.0

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Boston Scientific (Master Brand DFUTemplate 8.5in x 11in Global, 90106042 RevAN), MB, AngioJet Ultra System Operators Manual, Global, 91024738-01C
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
TABLE OF CONTENTS
DEVICE DESCRIPTION ..........................................................................................................4
The AngioJet™ Ultra 5000A Console (Console)...........................................................4
Figure 1. AngioJet Ultra 5000A Console...................................................................4
The AngioJet™ Ultra Thrombectomy Set
(Thrombectomy Set - Several models available) ........................................................5
Figure 2. Thrombectomy Set ......................................................................................5
INTENDED USE/INDICATIONS FOR USE ...........................................................................5
CONTRAINDICATIONS..........................................................................................................5
WARNINGS AND PRECAUTIONS .......................................................................................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 SYSTEM ........................................................................6
Clinician Use Information ................................................................................................6
Prepare Console ...............................................................................................................6
Figure 3. .........................................................................................................................6
Figure 4. .........................................................................................................................6
Load Pump .........................................................................................................................7
Figure 5. .........................................................................................................................7
Figure 6. .........................................................................................................................7
Figure 7. .........................................................................................................................7
Figure 8. Reference Only ............................................................................................7
Prime the Catheter............................................................................................................7
Figure 9. .........................................................................................................................7
Figure 10. .......................................................................................................................8
Figure 11. .......................................................................................................................8
Figure 12. .......................................................................................................................8
Figure 13. .......................................................................................................................8
Ultra System Dismantling ................................................................................................8
Figure 14. .......................................................................................................................8
ANGIOJET ULTRA 5000A CONSOLE SYMBOL TRANSLATION KEY ..............................9
MAINTENANCE, TROUBLESHOOTING AND SERVICE ....................................................9
Alarms and Error Messages ...........................................................................................9
Figure 15. Example of alarm .......................................................................................9
Figure 16. Example.....................................................................................................10
Ultra System Errors ........................................................................................................10
Figure 17. Example.....................................................................................................10
GLOSSARY OF TERMS ........................................................................................................10
WARRANTY ..........................................................................................................................10
SPECIFICATIONS..................................................................................................................11
ELECTROMAGNETIC COMPATIBILITY .............................................................................11
Table 1. Guidance and manufacturer’s declaration –
electromagnetic emissions......................................................................................11
Table 2. Guidance and manufacturer’s declaration –
electromagnetic immunity........................................................................................12
Table 3. Recommended separation distances between portable and mobile
RFcommunications equipment and the AngioJet Ultra 5000A Console ..........13

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ONLY
Caution: Federal Law (USA) restricts this device to sale by or on the order of a
physician.
The Console is intended for use only in conjunction with an AngioJet™ Ultra
Thrombectomy Set. Refer to the individual Thrombectomy Set Directions for Use
manual for specific clinical applications.
DEVICE DESCRIPTION
This manual provides instructions for operating the AngioJet™ Ultra System, with
specific focus on the AngioJet Ultra 5000A Console.
The AngioJet Ultra System consists of the following components:
The AngioJet Ultra 5000A Console (Console)
The Console is a multiple-use device that controls the Thrombectomy Set. It drives
the pump, regulates uid inow and outow, 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 switch.
Contents
One (1) Console
One (1) Operator’s Manual
One (1) Foot switch with cord
One (1) Power cord
Figure 1. AngioJet Ultra 5000A Console
AngioJet™Ultra 5000A
Console
Operator’s Manual Control Panel
Drawer
Open/Close
Button
Roller Pump
Pump Drawer
Main Power Circuit
Breaker Switch
Foot Switch
Bracket
Power Cord
Foot Switch

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Boston Scientific (Master Brand DFUTemplate 8.5in x 11in Global, 90106042 RevAN), MB, AngioJet Ultra System Operators Manual, Global, 91024738-01C
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The AngioJet™ Ultra Thrombectomy Set
(Thrombectomy Set - Several models available)
The single-use, disposable Thrombectomy Set includes:
• Catheter
• Pump
• Salinedeliverytubingandwastetubing
• Collectionbag
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.
INTENDED USE/INDICATIONS FOR USE
The Console is intended for use only in conjunction with an AngioJet Ultra
Thrombectomy Set. Refer to the individual Thrombectomy Set Directions for Use
manual for specific clinical applications.
CONTRAINDICATIONS
Refer to the individual Thrombectomy Set Directions for Use manual for specific
contraindications.
WARNINGS AND PRECAUTIONS
The AngioJet™ Ultra System should be used only by operators who have received
appropriate training on its installation and use.
• UsetheAngioJet™Ultra5000A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Directions 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Directions for Use manual for specific
instructions regarding heparinization of the Thrombectomy Set.
• 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.
• Toavoidtheriskofelectricshock,thisequipmentmustonlybeconnectedtoa
supply mains with protective earth.
• Wherethe“Trapping Zone Hazard for Fingers” symbol is displayed on the
console, there exists a risk of trapping or pinching fingers during operation and
care must be exercised to avoid injury.
• 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.
• TheAngioJetUltra5000AConsoleshouldnotbeusedadjacenttoorstacked
with other equipment, and if adjacent or stacked use is necessary, the AngioJet
Ultra 5000A Console should be observed to verify normal operation in the
configuration in which it will beused.
• Portableandmobileradiofrequency(RF)communicationsequipmentcanaffect
MEDICAL ELECTRICAL EQUIPMENT.
• Theuseofaccessoriesandcablesotherthanthosespecified,withthe
exception of accessories and cables sold by Boston Scientific as replacement
parts for internal components, may result in increased EMISSIONS or
decreased IMMUNITY of the Ultra 5000A Console.
• MEDICALELECTRICALEQUIPMENTneedsspecialprecautionsregarding
Electro-Magnetic Compatibility (EMC) and needs to be installed and put into
service according to the EMC information provided in the tables provided
below.
POTENTIAL ADVERSE EFFECTS
Refer to the individual Thrombectomy Set Directions for Use manual for specific
observed and/or potential adverse events.
HOW SUPPLIED
This product is supplied non-sterile and is intended for multiple use.
Do not use if package is opened or damaged.
Do not use if labeling is incomplete or illegible.
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
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
Storage 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
Pump
Catheter
Delivery and
waste tubing
Collection
Bag

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USING THE ANGIOJET™ ULTRA SYSTEM
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 Ultra System error
has occurred.
PleaseWait Prime Catheter
Install Pump Ultra System
Ready
Connect Saline
Contact
Boston
Scientific
Customer
Service
Status Panel Provides instructions, procedure
status, and alram resolution
strategies.
Power Button Press to activate the control panel.
Alarm Reset Button Press to clear or override an alarm.
Catheter Button Displays catheter model installed in
the AngioJet™ 5000A Ultra Console.
Press this button to see a 3-second
display of catheter model.
Scroll Buttons These buttons are active only when
there is more text to be displayed
than can fit on the status panel
screen.PresstheDOWNbutton
to advance one screen forward;
press the UP button to return to the
previous screen.
Counter Reset Button Press this button to return the time
display and infused volume to zero.
Note: You cannot use the COUNTER RESET Button to override the time needed for
priming the catheter.
Clinician Use Information
A thorough understanding of the Ultra 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
UltraSystem.
Improper Ultra System preparation or abnormal component operation will result in
error messages. Please refer to Alarms and Error Messages in the Maintenance,
Troubleshooting and Service Section of this manual for instructions on what to do if
error messages are displayed.
Prepare Console
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 Ultra 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.
1. Plug in the Console and ensure the main power circuit breaker switch is turned
ON (Figure 3).
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 Ultra System). Hang the saline bag on the saline bag
hook at the top of the Console.
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 step (Figure 4).
Figure 4.
Time Display Counter Reset
Button
Icons
Status Panel
Scroll Buttons
Alarm Reset
Button
Power
Button
Catheter
Identication
Button
Main Power
Circuit Breaker
Switch

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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).
Note: If a clamp is used to keep the catheter in the sterile field, ensure that the
clamp does not deform the tubing.
Figure 5.
2. Nonsterile technician: Remove the pump (not the piston head) from the tray and
insert the pump into the Console. Ensure that the waste tubing aligns with the
roller pump (Figure 6).
Figure 6.
3. Remove the cap from the Thrombectomy Set bag spike and insert the spike into
the saline bag.
4. Push the drawer button to close the Console drawer (Figure 7).
Figure 7.
The Console will load the pump and process information from a 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 8 Reference Only).
The Console will automatically prime the pump.
5. Place the foot switch within easy access of the physician. Choose a location
that will minimize accidental activation.
Figure 8. Reference Only
Prime the Catheter
The status panel displays PRIME indicating that the initial pump prime was
successful (Figure 9).
Catheter priming time is determined by the catheter model and is automatically set
by the Console.
Figure 9.
Delivery
Tubing Waste
Tubing
Roller
Pump

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Boston Scientific (Master Brand DFUTemplate 8.5in x 11in Global, 90106042 RevAN), MB, AngioJet Ultra System Operators Manual, Global, 91024738-01C
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1. Prime the catheter by completely submerging the tip in heparinized saline and
pressing the foot switch (Figures 10 and 11).
Figure 10. Figure 11.
2. Continue priming until the time display reaches zero seconds.
The status panel displays PRIME COMPLETE (Figure 12).
3. Confirm Ultra System set-up is successfully completed by removing foot from
footswitch.
Figure 12.
Status panel displays READY and green icon is illuminated (Figure 13).
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, and the time display will keep track of the total time that the
foot switch is activated.
Caution: Do not move the collection bag during catheter operation as this may
cause a collection bag error.
Figure 13.
Ultra 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. Carefully remove Thrombectomy Set from Console.
3. 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.
5. Unplug the power cord from the wall outlet and coil the cord on the hooks in
the power cord and foot switch recess. Place the foot switch into the storage
bracket at the bottom of the recess.
6. Clean the Console surfaces thoroughly with a standard, mild germicidal
cleaning agent. Do not clean with harsh detergent or chemical agents.
Note: Check bar code window for saline build-up, clean with long cotton-tipped
swab and water, if necessary (Figure 14).
Figure 14.
Bar Code
Window

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Boston Scientific (Master Brand DFUTemplate 8.5in x 11in Global, 90106042 RevAN), MB, AngioJet Ultra System Operators Manual, Global, 91024738-01C
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ANGIOJET™ ULTRA 5000A CONSOLE SYMBOL TRANSLATION KEY
REF
Catalog Number
Follow Instructions for Use
Contents
EC REP EU Authorized Representative
Legal Manufacturer
LOT
Lot
Recyclable Package
AUS Australian Sponsor Address
ARG Argentina Local Contact
BRA Brazil Local Contact
TUR Turkey Local Contact
Do not use if package
is damaged.
00 %
00 %
Humidity Limitation(s)
Defibrillation-Proof Type CF Applied Part
CAUTION
Attention: Consult ACCOMPANYING DOCUMENTS.
Separate Collection
Equipotentiality
Fuse
Foot Switch
Alternating Current
Time Lag
0000 °C
0000 °C
Temperature Limitation(s)
0000 kPa
0000 kPa
Atmospheric Pressure Limitation
Date of Manufacture
SN Serial Number
ANGIOJET™ ULTRA 5000A CONSOLE SYMBOL TRANSLATION KEY
NON
STERILE Non-Sterile
ON (power: connection to mains)
OFF (power: disconnection to mains)
Standby
Eject (open/close drawer)
Pushing Prohibited
Trapping Zone Hazard for Fingers
Non-Ionizing Electromagnetic Radiation
3LEU
Medical Equipment
ANSI/AAMI ES 60601-1
CAN/CSA C22.2 No. 60601-1
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 5000A
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 Ultra System preparation or abnormal
component operation.
The Console status panel will display alarm resolution messages and prompts
(Example shown in Figure 15). 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 15. Example of alarm

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The Console allows multiple attempts to correct most alarm conditions. If the alarm
persists beyond the third attempt, it is most likely that the Thrombectomy Set has
a defect and the Console will prompt the user to replace the Thrombectomy Set
(Figure16).
Figure 16. Example
Ultra System Errors
A system failure will result in a system error (wrench icon lights red, shown in
Figure 17). Turn off the power, then restart before contacting Boston Scientific
Customer Service for further instructions.
It is helpful to make a note of each system error title and number to report to Boston
Scientific Customer Service.
Figure 17. Example
GLOSSARY OF TERMS
Alarm: A recoverable or nonrecoverable fault occurring when one of the Ultra
System safety sensors responds to abnormal operation of a component.
Waste Tubing: The tubing which is inserted in the roller pump and transports the
extracted thrombus from the effluent tubing to the collection bag.
Collection Bag: The bag which collects the extracted thrombus being removed by
the Catheter. The bag hangs on the Console
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.
Load Pump: An indicator instructing 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 be
necessary.
Thrombectomy Set: The disposable component of the Ultra System which delivers
pressurized saline to the catheter and removes debris from the catheter. It consists
of the saline bag spike, saline delivery tubing, pump, catheter, waste tubing, and
collection bag.
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.
Total Infused Volume: The numerical display on the control panel which displays the
total volume of saline infused in cc.
Under Pressure Alarm: A recoverable condition occurring when an abnormally low
pressure has been detected.
WARRANTY
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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SPECIFICATIONS
Model Number 5000A
Dimensions 25 in x 16.5 in x 54 in
DxWxH (63.5 cm x 42 cm x 137 cm)
Weight 140 lbs (63.5 kg)
Voltage requirements
100/120/220/240
Frequency requirements 50/60 Hz
Power requirements 900VA
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 10 °C to 40 °C (50 °F to 104 °F)
Storage relative humidity 30% to 75% (noncondensing)
Storage atmospheric pressure 700 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, T10A, 250V, 5X20 mm
220/240V, T6.3A, 250V, 5X20 mm
Cables AC adapter cable, Cord Length 10 feet
(3.05 m)
Foot Switch Cord Length 15 feet (4.57 m)
The AngioJet™ Ultra 5000A Console is compliant with ANSI/AAMI ES 60601-1,
CAN/CSA C22.2 No. 60601-1, IEC 60601-1 and EN 60601-1.
Note: Replace fuse with the type and rating specified. Failure to do so may result in
device damage or risk of fire.
ELECTROMAGNETIC COMPATIBILITY
Medical Electrical Equipment needs special precautions regarding electromagnetic
compatibility (EMC) and needs to be installed and put into service according to the
EMC information provided in the documents accompanying the equipment. Portable
and mobile RF communications equipment can affect Medical Electrical Equipment.
Use of a power cord other than the cord supplied may result in increased emissions
or decreased immunity of the System.
Table 1. Guidance and manufacturer’s declaration – electromagnetic emissions
The AngioJet Ultra 5000A Console is intended for use in the electromagnetic
environment specified below. The customer or the user of the AngioJet Ultra 5000A
Console should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment –
guidance
RF emissions (CISPR 11) Group 1
The AngioJet Ultra 5000A Console
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.
RF emissions (CISPR 11) Class A The AngioJet Ultra 5000A
Console 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.
Harmonic emissions
(IEC 61000-3-2) Class A
Voltage fluctuations flicker/
emissions (IEC 61000-3-3) Complies

12
Boston Scientific (Master Brand DFUTemplate 8.5in x 11in Global, 90106042 RevAN), MB, AngioJet Ultra System Operators Manual, Global, 91024738-01C
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
Table 2. Guidance and manufacturer’s declaration – electromagnetic immunity
IMMUNITY test IEC 60601 test level Compliance level Electromagnetic environment – guidance
Electrostatic discharge (ESD)
(IEC 61000-4-2)
± 6 kV contact
± 8 kV air
± 6 kV contact
± 8 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 for power supply lines
± 1 kV for input/output lines
± 2 kV for power supply lines Mains power quality should be that of a typical commercial or
hospital environment.
Surge
(IEC 61000-4-5)
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
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 s
< 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 s
Mains power quality should be that of a typical commercial or
hospital environment. If the user of the AngioJet™ Ultra 5000A
Console requires continued operation during power mains
interruptions, it is recommended that the AngioJet Ultra 5000A
Console be powered from an uninterruptible power supply or
abattery.
Power frequency (50/60 Hz)
magnetic field
(IEC 61000-4-8)
3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a
typical location in a typical commercial or hospital environment.
Portable and mobile RF communications equipment should be used
no closer to any part of the AngioJet Ultra 5000A Console, including
cables, than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended Separation Distance
Conducted RF
(IEC 61000-4-6) 3 Vrms 150 kHz to 80 MHz 3 Vrms d = 1.77 √P
d = 1.77 √P80 MHz to 800 MHz
Radiated RF
(IEC 61000-4-3) 3 V/m 80 MHz to 2.5 GHz 3 V/m
d = 2.33 √P80 MHz to 2.5 MHz
where Pis the maximum output power rating of the transmitter in
watts(W)accordingtothetransmittermanufactureranddis the
recommended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey,ashould 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 U
t
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.
aField 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 System is used
exceeds the applicable RF compliance level above, the System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating
the System.
bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

13
Boston Scientific (Master Brand DFUTemplate 8.5in x 11in Global, 90106042 RevAN), MB, AngioJet Ultra System Operators Manual, Global, 91024738-01C
Black (K) ∆E ≤5.0Black (K) ∆E ≤5.0
Table 3. Recommended separation distances between portable and mobile RF
communications equipment and the AngioJet™ Ultra 5000A Console
The AngioJet Ultra 5000A Console is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or
the user of the AngioJet Ultra 5000A Console can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile
RF communications equipment (transmitters) and the AngioJet Ultra 5000A
Console as recommended below, according to the maximum output power of the
communicationsequipment.
Rated maximum
output power
of transmitter (W)
Separation distance according to frequency of transmitter
(m)
150 kHz
to 80 MHz
d = 1.17√P
80 kHz
to 800 MHz
d = 1.17√P
800 MHz
to 2.5 GHz
d = 2.33√P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1.17 1.17 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 equation applicable to the frequency of the transmitter, where P
isthemaximumoutputpowerratingofthetransmitterinwatts(W)accordingtothetransmittermanufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for 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 and people.

91024738-01
Boston Scientific (Master Brand DFUTemplate 8.5in x 11in Global, 90106042 RevAN), MB, AngioJet Ultra System Operators Manual, Global, 91024738-01C
Black (K) ∆E ≤5.0
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