Irrigation Pump

User Manual
SAP_UM_04-00_EN
Irrigation Pump User Manual

Table of Contents

Preface iii
1 Indications 1
2 Warnings 2
3 Pump Setup 5
3.1 Controls on the Front of the Pump...................................................................................................... 5
3.2 Controls on the Back of the Pump........................................................................................................ 6
3.3 Diagram of the Pump with the SmartAblate™ RF Generator and Accessories........................ 7
3.4 Pump Location............................................................................................................................................. 8
3.5 Mains Connection...................................................................................................................................... 8
3.6 Fuses................................................................................................................................................................ 8
3.7 Circular Plug Connections....................................................................................................................... 8
3.8 Potential Equalization............................................................................................................................... 9
3.9 Foot Pedal Connection............................................................................................................................. 9
3.10 Connection to the RF Generator........................................................................................................... 9
3.11 Adjusting the Volume, Brightness, and Language......................................................................... 9
3.12 Cleaning and Disinfecting the Pump................................................................................................10
3.13 Protecting against Damage..................................................................................................................10
3.14 Disposal........................................................................................................................................................11
4 Accessories 12
4.1 Foot Pedal....................................................................................................................................................12
4.2 SmartAblate™ Cables.................................................................................................................................12
4.3 Other Accessories.....................................................................................................................................13
5 Pump Operation 14
5.1 Turning the Pump On and Off..............................................................................................................14
5.2 Installing the SmartAblate™ Irrigation Tubing Set in the Pump.................................................14
5.3 Flushing to Eliminate Air in the Tubing and Catheter.................................................................15
5.4 Starting the Irrigation Flow...................................................................................................................16
5.5 Setting the Low (Standby) and High (Ablation) Flow Rates......................................................16
5.6 Stopping the Irrigation Flow................................................................................................................17
5.7 Air Bubble Error.........................................................................................................................................17
5.8 Communication with the SmartAblate™ RF Generator.................................................................17
5.9 Foot Pedal....................................................................................................................................................17
6 Troubleshooting 18
6.1 Warnings......................................................................................................................................................18
6.2 Errors.............................................................................................................................................................20
6.3 System Errors..............................................................................................................................................21

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Irrigation Pump User Manual

6.4 Other Troubleshooting...........................................................................................................................22

6.5 Determining the Pump’s Serial Number and Software Version...............................................22
7 Technical Data 23
7.1 Specifications.............................................................................................................................................23
7.2 Storage and Shipping Conditions......................................................................................................24
7.3 Operating Conditions.............................................................................................................................24
7.4 Safety Inspections....................................................................................................................................24
7.5 Maintenance...............................................................................................................................................24
7.6 Repairs..........................................................................................................................................................25
7.7 Conformance to Standards...................................................................................................................25
7.8 EMC Information and Technical Description..................................................................................26
7.9 Alarm Specifications................................................................................................................................30
8 Symbols 32
9 Warranty 34
9.1 Transit Damage.........................................................................................................................................34
9.2 Warranty.......................................................................................................................................................34
9.3 Product Liability........................................................................................................................................34

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Irrigation Pump User Manual

Preface
The SmartAblate™ Irrigation Pump is a peristaltic pump designed to work in conjunction with the
SmartAblate™ RF Generator to deliver irrigation solution at specified flow rates to irrigated catheters
(such as the Biosense Webster Celsius® ThermoCool® Catheters and NaviStar® ThermoCool® Catheters)
for cooling purposes. The pump is used with the SmartAblate™ Irrigation Tubing Set that conducts
the irrigation solution from an external source to the compatible irrigated catheters.

The SmartAblate™ Irrigation Pump was designed to allow simple, intuitive, and user-friendly
operation. When connected to the SmartAblate™ RF Generator by the supplied interface cable, the
pump can be controlled directly from the user interface of the generator. Simultaneously, the pump
transfers status information regarding solution flow rates back to the SmartAblate™ RF Generator
to allow safe operation. If an error occurs in either of these devices, the necessary notification and
recovery steps are initiated simultaneously in both devices.

The pump can be operated directly from the pump user interface when it is not connected to the
SmartAblate™ RF Generator.

Use of the SmartAblate™ Irrigation Pump requires familiarity with the device and its operation. The
user should read this manual, which describes how to operate the SmartAblate™ Irrigation Pump,
and should attend a presentation on the operation and configuration of the pump provided by
Biosense Webster. The user should also become familiar with the SmartAblate™ RF Generator and all
accessories and read their instructions for use before using the generator or accessories.

For more information on training options, please contact Biosense Webster.

We will gladly answer any questions that you may have.

Yours truly,

STOCKERT GmbH

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Irrigation Pump User Manual

1 Indications
The SmartAblate™ Irrigation Pump is a peristaltic pump designed to work in conjunction
with the SmartAblate™ RF Generator to deliver irrigation solution at specified flow rates to
irrigated catheters (such as the Biosense Webster Celsius® ThermoCool® Catheters and NaviStar®
ThermoCool® Catheters) for cooling purposes. The pump is used with the SmartAblate™ Irrigation
Tubing Set that conducts the irrigation solution from an external source to the compatible
irrigated catheters.

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Irrigation Pump User Manual

2 Warnings
1. Before setting up the SmartAblate™ Irrigation Pump for the first time, carefully read this user
manual. Pay special attention to the instructions in Chapter 3, Pump Setup. Also read the
user manuals for the SmartAblate™ RF Generator and the accessories and familiarize yourself
with their use.

2. Always verify that the pump’s visual and acoustic alarms are working before using the pump
(see Section 5.1, Turning the Pump On and Off ).

3. When the pump has been turned off, power continues to be supplied to the pump through
the mains cable. To completely cut off power to the pump, disconnect the mains cable from
the pump. To allow easy disconnection in the event of severe power failure, make sure that
the pump is located where there is easy access to the mains cable.

4. After turning on the pump, always wait until the automatic self test has been successfully
completed before starting the first steps of the procedure on the patient (for example,
before anesthesia or before creating percutaneous access). Doing this helps to detect
problems with the device before the patient is in a phase of the intervention in which
interruption could lead to an increased risk to the patient’s health.

5. Use only accessories that have been provided by or recommended by the pump’s
manufacturer (see Chapter 4, Accessories). The use of other accessories can have a negative
effect on the technical specifications. Do not modify accessories. Visually inspect all
accessories on a regular basis. Make sure that the connected cables are not damaged. When
using sterile accessories, be sure to maintain the sterility of those accessories.

6. Inspect the pump for damage before each use (see Section 7.5, Maintenance).

7. Special safety measures with regard to electromagnetic compatibility (EMC) must be

taken with electrical medical devices. Portable and mobile communication devices may
cause harmful interference to the functioning of the pump. Do not use portable or mobile
communication devices in the vicinity of the SmartAblate™ Irrigation Pump.

8. Radio interference and electromagnetic fields can trigger false alarms and malfunctions
in electrical units such as the SmartAblate™ Irrigation Pump. Furthermore, use of electrical
units such as this pump can occasionally result in wrong values on ECG monitors that are
not operated under optimal conditions. Although the pump is designed to avoid such
interference, when the pump is used with electromagnetic navigation systems and ECG
monitors, verify correct operation of the connected devices before use on a patient. If
interference occurs, move the pump to another location.

9. If error messages repeatedly appear, stop using the pump and contact Customer Support.

10. To avoid damage to the pump and its accessories, use only appropriate cleaning agents (see
Section 3.12, Cleaning and Disinfecting the Pump).

11. There are no parts in the SmartAblate™ Irrigation Pump that may be serviced by the user.
(Exception: The fuses may be replaced per Section 3.6, Fuses.)

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12. The pump enclosure may be opened only by persons authorized by the manufacturer. When
the pump enclosure is open, parts that have high voltage or are very hot are accessible and
can cause injury. If the pump enclosure is opened by an unauthorized person, any claims on
the warranty are void. No modification of the pump is permitted.

13. The SmartAblate™ Irrigation Pump was calibrated by the manufacturer. Changing pump
settings other than those described in Chapter 5, Pump Operation, will result in improper
functioning and will void the warranty.

14. If fluid penetrates into the pump, stop using the pump and contact Customer Support.

15. Use the SmartAblate™ Irrigation Pump only in combination with the SmartAblate™ Irrigation
Tubing Set. If unsuitable tubing is used, the pump will not function properly and improper
irrigation will result.

16. The sterile SmartAblate™ Irrigation Tubing Set is intended for one-time patient use. To avoid
biological contamination and ensure proper functioning, do not reuse or resterilize the
tubing set.

17. The SmartAblate™ Irrigation Pump monitors the flow of irrigation solution. If there is a
problem with the solution flow, the pump stops the flow and issues an alarm. Correct alarm
situations and restart the flow as quickly as possible.

18. The hospital staff is responsible for ensuring that the pump is functioning properly and
that the solutions and irrigated catheters that are used in the overall irrigation process
are compatible with each other. The SmartAblate™ Irrigation Pump and the SmartAblate™
Irrigation Tubing Set are intended for use with a standard irrigation solution such as a
normal isotonic saline solution. The precision of the flow rate stated in the technical data
may not be maintained if incompatible fluids and/or incompatible irrigated catheters are
used.

19. The SmartAblate™ Irrigation Pump may be operated in the immediate vicinity of the
SmartAblate™ RF Generator. However, do not operate the pump in the immediate vicinity
of devices that are not approved for electromagnetic compatibility (EMC) with the pump. If
such operation is unavoidable, regularly monitor the pump to ensure proper functioning.

20. Do not connect the SmartAblate™ Irrigation Pump to other infusion systems, including
gravity intravenous (IV) infusion systems.

21. To prevent explosions, do not use the pump near explosive anesthetics.

22. To prevent electric shock and fires, do not expose the pump to excessive humidity.

23. To avoid the risk of electric shock, connect the pump to a 3-prong mains outlet that meets
the specifications in Section 7.1, Specifications.

24. Parts such as the intravenous (IV) pole clamp, the rotating pump head, and the door that
covers the pump head are designed for safe operation but must be used with caution.

2 Warnings | Page 3
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25. The SmartAblate™ Irrigation Pump is intended for use with irrigated catheters. Monitor the
irrigation flow rate to avoid hazards caused by insufficient irrigation flow. Monitoring the
flow rate on the pump display alone is not sufficient because the flow rate is calculated
from the pump motor speed. If the pump fails to rotate at the speed set by the user, the
pump issues an alarm. However, because it is possible for a situation to arise during which
the motor head is rotating but there is no flow, it is important to repeatedly monitor the
approximate flow rate by observing the drip speed in the drip chamber. The drip chamber
should be half to three-quarters filled to ensure no bubbles enter the tubing and provide
visibility of the drip speed. The hospital staff is responsible for determining and monitoring
the flow rate to avoid insufficient flow of the irrigation solution. The hospital staff is
responsible for monitoring the total amount of solution delivered to the patient to avoid an
excessive loading of the irrigation solution in the patient. For recommended flow rates, refer
to the catheter’s instructions for use.

26. The person who connects the devices and accessories to each other or who uses the devices
and accessories is responsible and liable for installation and operation that complies with
IEC/EN 60601‑1‑1.

27. All system components must comply with all applicable requirements and standards and
must be labeled pursuant to these standards.

28. If there are any concerns regarding the use of a component, contact the distributor of the
component to obtain further information.

29. The pump, the generator, and all accessories connected to the pump or generator, when
located within the patient area, must comply with IEC/EN 60601‑1 and its sub‑standards.

30. If several devices are connected to each other, they should be as safe, both individually and
together, as specified in IEC/EN 60601-1 and its sub‑standards and IEC/EN 60601‑1‑2.

31. Do not put any labels or stickers on the front of the pump that will obscure the buttons or
indicator lights.

32. The pump should be used only when the use of irrigation solution is appropriate relative
to the medical condition of the patient. If it is not known what influence irrigation solution
might have on a patient, consult with appropriate medical professionals before using this
device.

33. When the pump is used alone for an ablation procedure, without being controlled by an
RF generator, high flow of the irrigation solution should be started before the RF energy is
turned on to allow the desired flow rate to be reached at the tip of the catheter. High flow
should be continued for a few seconds after the RF energy is turned off in order to avoid
thrombus formation on the ablation electrode.

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3 Pump Setup
3.1 Controls on the Front of the Pump

8 9 10 11 12

7 13
6 14

5
4

3
15

2 16

17
1

Item Description
1 Pump head pressure plate
2 Pump head
3 Flush button
4 Stand-by button
5 Stand-by indicator
6 Stop button
7 Alarm indicator
8 Active flow rate
9 Selected high (ablation) flow rate
10 Selected low (standby) flow rate
11 High (Ablation) Flow knob
12 High (Ablation) Flow button
13 Low (Standby) Flow knob
14 Low (Standby) Flow button

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Item Description
15 Pump door*
16 Air bubble indicator
17 Air bubble sensor
*The transparent pump door allows viewing of the tubing and the pump head rotation.

3.2 Controls on the Back of the Pump

18

DEVICE LABEL
19

20

25

24

23 22 21

Item Description
18 Device label
19 Mains rating label
20 Sensor receptacles, and indicators (not functional)
21 Communication receptacles for RF generator, and indicators
22 Receptacle for foot pedal, and indicator
23 Mains socket
24 Potential equalization port
25 Fuse cover

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3.3 Diagram of the Pump with the SmartAblate™ RF Generator and Accessories

Patient Area
10
1

2
3

9 4

8
7
6

Item Description
1 SmartAblate™ Irrigation Pump
2 Mains cable*
3 Grounding cable*
4 Foot pedal*
5 Catheter
6 SmartAblate™ RF Generator
7 SmartAblate™ Irrigation Pump connection cable*
8 Catheter connection cable
9 SmartAblate™ Irrigation Tubing Set*
10 Fluid bag
*See Chapter 4, Accessories.

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3.4 Pump Location

The SmartAblate™ Irrigation Pump can be located in any of the following locations:

• On a clean, flat, stable surface

• On a Carto® 3 System cart
• On an intravenous (IV) pole (see the instructions for use provided with the pole clamp)

3.5 Mains Connection

The SmartAblate™ Irrigation Pump automatically adjusts for the necessary mains
voltage and frequency. To avoid the risk of electric shock, connect the pump to a
3‑prong mains outlet that meets the specifications in Section 7.1, Specifications. Use
only the mains cable supplied by the manufacturer or distributor for the country
where the pump is being used.

3.6 Fuses

Externally accessible fuses for the SmartAblate™ Irrigation Pump are located under
the fuse cover (see Item 25 in Section 3.2, Controls on the Back of the Pump). Use
only fuses approved by the manufacturer.

3.7 Circular Plug Connections

The circular plugs on the SmartAblate™ System cables and the

SmartAblate™ System foot pedal cable are color coded to ensure
simple and accurate connection to the receptacles of the same color
on the back of the SmartAblate™ Irrigation Pump (see Items 21 and 22
in Section 3.2, Controls on the Back of the Pump). The indicator for the
foot pedal receptacle and the indicator for the COMM 1 receptacle are
orange to indicate that the receptacles are functional and are ready
for connection. To connect a circular plug to the pump, align the arrow
on the plug with the mark on the receptacle and push in without
unnecessary force until a click indicates that the connector is locked
in the receptacle. If the plug does not fit in the receptacle, verify that
the color coding matches and that the number of pins in the plug is
appropriate for the receptacle. To remove a circular plug, gently pull
back the sleeve on the plug and pull the plug out of the receptacle.

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3.8 Potential Equalization

To avoid differences in potential between the pump and other devices with power
operation, the SmartAblate™ Irrigation Pump must be connected to a grounding line
(as specified in IEC/EN 60601-1). Connect one end of the green and yellow potential
equalization cable provided with the pump to the grounding connection on the
back of the pump (see Item 24 in Section 3.2, Controls on the Back of the Pump).
Connect the other end to the room’s central grounding line. To avoid radiation
interference (noise) in the ECG signal, always use the same grounding line for
connection of all devices involved (electrocardiograph, Carto® System, generator).

3.9 Foot Pedal Connection

See Section 3.7, Circular Plug Connections.

3.10 Connection to the RF Generator

Turn on the RF generator and the SmartAblate™ Irrigation Pump (see Section 5.1, Turning the
Pump On and Off ).

Plug the connection cable from the RF generator into the COMM 1 receptacle on the back of
the pump as described in Section 3.7, Circular Plug Connections. For additional instructions, see
Section 5.8, Communication with the SmartAblate™ RF Generator.

3.11 Adjusting the Volume, Brightness, and Language

Options Screen
Sound volume

Button brightness

Language

Turn off the pump and close the pump door.

Press and hold the Low (Standby) Flow button while you briefly press the
Stand-by button. Release the Low (Standby) Flow button when the Options screen appears.

Turn the High (Ablation) Flow knob until > appears to the left of the setting that
you want to change.

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Then turn the Low (Standby) Flow knob to change the sound volume, button
brightness, or language setting.

Press the Stand-by button to remove the information from the screen. The pump will
turn off.

Note: The Service selection on the Options screen is for use by a service engineer certified by the
manufacturer.

3.12 Cleaning and Disinfecting the Pump

WARNINGS
• The SmartAblate™ Irrigation Pump must be turned off and the mains cable must be
disconnected from the pump before cleaning and disinfecting the pump.
• The SmartAblate™ Irrigation Pump, the mains cable, and the connection cable to the
SmartAblate™ RF Generator must not be sterilized.
Use a dry microfiber cloth to clean the pump’s screen. If damp cleaning is necessary, moisten a
soft cotton or linen cloth with commercial grade glass cleaner that does not contain alcohol and
wipe the screen. Do not spray the cleaner directly onto the screen.

Use a soft, damp, lint‑free cloth to clean and disinfect the housing of the pump. Use only
non‑flammable and non‑explosive substances. Water or soapy water is recommended for
cleaning. Make sure that no liquid penetrates the inside of the pump.

The following disinfectants can be used for disinfecting the pump and its cables:

• Lysoformin® spezial
• Kodan®
• Meliseptol®
• Commercial disinfectants that do not contain ethyl alcohol
Caution: The following substances must not be used: acetone, benzene, acids of any kind
(including acetic acid and citric acid), scouring agents, nitro dilutions and other organic solvents.
Do not use any agent containing ethyl alcohol to clean the pump. Iodine or disinfectants
containing dyes cause discoloration of the housing and should not be used. Perform disinfection
by wiping, not spraying. Avoid condensation. If cleaning or disinfecting the pump with
flammable or explosive substances cannot be avoided, make sure these substances have
completely evaporated before the pump is turned on.

3.13 Protecting against Damage

In addition to being operated and maintained per the instructions in this user manual, the
SmartAblate™ Irrigation Pump must also be protected against damage. This includes installing
the pump in a safe location and protecting the pump against moisture, contamination, and
contact with flammable or explosive substances.

Make sure that all cables to devices and accessories are arranged in a way that prevents tripping.

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Irrigation Pump User Manual

To transport the pump over long distances or to send the pump for service, use the original
packaging. If the original packaging is not available, contact the manufacturer or distributor for a
replacement.

3.14 Disposal

Inadequately treated electronic waste poses environmental and health risks. Follow local
regulations for disposal of the SmartAblate™ Irrigation Pump and its electrical or electronic
accessories. To ensure proper disposal, there is the option of contacting your Biosense Webster
representative regarding return of the pump and its accessories.

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4 Accessories

WARNING
Use only the original accessories provided by or recommended by STOCKERT GmbH or Biosense
Webster for the SmartAblate™ Irrigation Pump. If you use accessories not authorized by the
manufacturer, the safety of the device and system is not guaranteed.

4.1 Foot Pedal

Item Part #
Foot Pedal, length of connection cable: 3 m
Worldwide, except China M490005
China M4900405

Foot Pedal Extension Cable, length: 7 m M490026

(Redel‑6 à Redel‑6, black)

4.2 SmartAblate™ Cables

Item Part #
Connection Cable from SmartAblate™ RF
Generator to SmartAblate™ Irrigation Pump
(Redel‑10 à Redel‑10, blue)
length: 1 m M490027
length: 3 m M490016
length: 5 m M490028
length: 10 m M490030

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Item Part #
Mains Cable, length: 3 m
Australia M4900601
Brazil M4900609
China M4900410
EU M4900108
India / South Africa M4900604
Israel M4900606
Japan M4900210
Russia M4900603
Switzerland M4900605
Taiwan M4900607
UK / Singapore / Hong Kong M4900602
USA M490024
Grounding Cable, length: 3 m
Worldwide, except Japan M490014

Japan M490015

4.3 Other Accessories

Item Part #
SmartAblate™ Irrigation Tubing Set SAT001

SmartAblate™ Irrigation Pump Intravenous M490037

—
(IV) Pole Clamp

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5 Pump Operation
Read this entire user manual before operating the SmartAblate™ Irrigation Pump.

The instructions in this chapter describe how to operate the SmartAblate™ Irrigation Pump using
the pump’s user interface. However, the pump can also be operated (including setting flow rates)
using the SmartAblate™ RF Generator user interface (see Section 5.8, Communication with the
SmartAblate™ RF Generator, and see the instructions in the user manual for the generator).

5.1 Turning the Pump On and Off

To turn the pump on, press the Stand-by button. The SmartAblate™ System logo
appears on the screen, the Alarm indicator and the air bubble indicator lights turn on red (see
Items 7 and 16 in Section 3.1, Controls on the Front of the Pump), and an audible tone is emitted
briefly. If the logo does not disappear after 3 seconds, or if the indicators do not light, or if the
tone cannot be heard, there could be a problem (see Section 6.4, Other Troubleshooting).

Note: If the generator is on when the pump is connected to the generator, the pump
automatically turns on. If the generator is off when the pump is connected to the generator, the
pump automatically turns on when the generator is turned on.

To turn the pump off, press the Stand-by button for at least 3 seconds.

Note: If the pump is connected to the generator and the generator is on, pressing the
pump’s Stand-by button puts the pump into sleep mode and the image at the right
appears in the middle of the pump’s screen. When the generator is turned off, the pump
automatically turns off.
Note: If the voltage of the internal battery is low, the image at the right appears at the
bottom of the pump’s screen. You can continue to use the pump when this image is
displayed but service will be required soon. Contact Customer Support.

5.2 Installing the SmartAblate™ Irrigation Tubing Set in the Pump

Warnings
• The tubing set is sterile and is intended for one-time patient use.
• The tubing set can be damaged if inserted incorrectly.
• Always use a new sterile tubing set obtained from its original packaging with each new
procedure.

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Install the SmartAblate™ Irrigation Tubing Set as described below. Also see the instructions for
use provided with the tubing.

Open the pump door (see Item 15 in Section 3.1, Controls on the
Front of the Pump).
Put the tubing between the pressure plate and the pump head
(see Items 1 and 2 in Section 3.1). Make sure that the arrows on the
tubing point in the same direction as the arrows on the pressure
plate. Make sure that the tubing is in the grooves in the plates on
each side of the pump head (see the arrows in the drawing at the
left).
Gently stretch the tubing that extends from the right side of the
pump head and insert it in the air bubble sensor (see Item 17 in
Section 3.1).

Close the pump door. The pressure plate compresses the tubing to
prevent fluid from flowing freely through the tubing set.
Take care not to pinch fingers when shutting the pump door.

After installing the tubing, flush the tubing as described in Section 5.3, Flushing to Eliminate
Air in the Tubing and Catheter. The pump will not start fluid delivery if the tubing has not been
flushed.

5.3 Flushing to Eliminate Air in the Tubing and Catheter

WarningS
• Irrigated catheters must be flushed before they are inserted in the patient.
• When flushing a catheter, the catheter must not be inside the patient. When flushing the
SmartAblate™ Irrigation Tubing Set, either the catheter must be outside the patient or the
4‑way stopcock on the tubing set must be turned so that the fluid is not routed to the
catheter.
After the tubing has been installed, perform the following steps:

Press and hold the Flush button to remove all air bubbles from the tubing and the
catheter. The pump head continues to rotate during flushing. The following images appear on
the screen during flushing to indicate whether bubbles are detected in the bubble sensor area.

Bubbles Detected During Flushing

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No Bubbles Detected During Flushing

Note: Flush for at least 5 additional seconds after the No Bubbles Detected During Flushing
image appears and after there are no visible bubbles in the tubing. This ensures that all bubbles
have been flushed from the catheter.

5.4 Starting the Irrigation Flow

Warning
Low (standby) flow of the irrigation solution must be started before the catheter is inserted into
the patient. If the catheter is introduced into the patient before irrigation is started, the holes in
the catheter’s tip electrode could become occluded due to thrombus formation.

Press the Low (Standby) Flow button to start the pump at the low (standby) flow rate.

Press the High (Ablation) Flow button to start the pump at the high (ablation) flow
rate. During high (ablation) flow, the High (Ablation) Flow button blinks as a reminder that high
(ablation) flow is selected and that it is possible to overload the patient with fluid.

Verify that the pump head is rotating. (The pump head is located behind the transparent pump
door. See Items 2 and 15 in Section 3.1, Controls on the Front of the Pump.)

5.5 Setting the Low (Standby) and High (Ablation) Flow Rates

WARNING
Refer to the instructions for use for the catheter to determine appropriate flow rates for the
catheter.

The flow rates can be changed at any time, including when low (standby) flow or high (ablation)
flow is active.

Turn the Low (Standby) Flow knob to set the low (standby) flow rate (milliliters per
minute).

Turn the High (Ablation) Flow knob to set the high (ablation) flow rate (milliliters
per minute).

Note: When the pump is connected to a SmartAblate™ RF Generator, the generator will impose
restrictions on the flow rate that can be set.

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5.6 Stopping the Irrigation Flow

Press the Stop button to stop the irrigation flow.

or

Press the Stand-by button briefly (less than 3 seconds) to stop the irrigation flow.

Remove the tubing after use.

5.7 Air Bubble Error

When an air bubble is detected in the SmartAblate™ Irrigation Tubing Set in

the area of the pump’s bubble sensor during high (ablation) or low (standby) flow, the pump
sounds an alarm, an error message and images appear on the pump’s screen, the Alarm indicator
light turns on, and the air bubble indicator light changes from green to red (see Section 3.1,
Controls on the Front of the Pump).

Immediately turn the 4-way stopcock on the SmartAblate™ Irrigation Tubing Set so that the fluid
is not routed to the catheter. Then, press the Stop button to stop the alarm sound. Flush the
bubble(s) from the tubing per Section 5.3, Flushing to Eliminate Air in the Tubing and Catheter.
After flushing, turn the 4-way stopcock to allow fluid to be routed to the catheter again.

Note: After an air bubble has been detected, the tubing must be flushed. It is not possible to start
fluid delivery using the Low (Standby) Flow or High (Ablation) Flow buttons if
flushing has not been performed.

5.8 Communication with the SmartAblate™ RF Generator

When the pump is properly connected to the SmartAblate™ RF Generator, this image
appears at the bottom of the pump’s screen. You can control the pump from the generator when
this image is displayed on the pump’s screen.

This grayed out image appears at the bottom of the pump’s screen when the pump is
connected to the generator and you use the pump’s user interface to adjust a pump setting. After
the generator recognizes the change, the white image shown above reappears.

5.9 Foot Pedal

If a SmartAblate™ System foot pedal is connected to the pump, the foot pedal can be pressed to
start the pump in high (ablation) flow mode. This is the same as pressing the High (Ablation)
Flow button. When the foot pedal is released, the flow continues at the low (standby)
flow rate.

When the foot pedal is properly connected to the pump, this image appears at the
bottom of the pump’s screen.

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Irrigation Pump User Manual

6 Troubleshooting
6.1 Warnings

AI = Alarm Indicator (see Item 7 in Section 3.1, Controls on the Front of the Pump)
BI = Bubble Indicator (see Item 16 in Section 3.1, Controls on the Front of the Pump)
Image AI BI Message Reason What To Do
Off Off none The door is open N/A – information only
during no flow.

On, Off Door open The door is open N/A – information only
red during high (ablation), (Opening the door during
low (standby), or flush motor rotation stops the
flow. pump.)
Off Blinks none A bubble was detected !! Patient danger !!
red during no flow either
because there is air in Immediately turn the 4-way
the tubing or because stopcock on the SmartAblate™
the tubing is not in the Irrigation Tubing Set so that
bubble sensor. the fluid is not routed to the
catheter. Be sure to clear the
bubble before starting the flow,
even if the warning message
disappears (see Section 5.3,
Flushing to Eliminate Air in
the Tubing and Catheter).
Note: Opening the door can
move the tubing slightly,
causing the bubbles to move
out of the bubble sensor area.
Inspect the tubing carefully!
none Off Off Button > The > low (standby) Release the > low (standby)
stuck? flow button was flow button. If the warning
pressed for more than does not disappear, contact
25 seconds or the > Customer Support.
button is stuck.
none Off Off Button >> The >> high Release the >> high (ablation)
stuck? (ablation) flow button flow button. If the warning
was pressed for more does not disappear, contact
than 25 seconds or the Customer Support.
>> button is stuck.
none Off Off Button The >>> flush flow Release the >>> flush flow
>>> stuck? button was pressed for button. If the warning does not
more than 25 seconds disappear, contact Customer
or the >>> button is Support.
stuck.

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Irrigation Pump User Manual

Image AI BI Message Reason What To Do

none Off Off Button The Stop button was Release the Stop button. If the
STOP pressed for more than warning does not disappear,
stuck? 25 seconds or the Stop contact Customer Support.
button is stuck.
none Off Off Button The > low (standby) Release the pressed button(s).
stuck? flow, >> high If the warning does not
(ablation) flow, >>> disappear, contact Customer
flush flow, or Stop Support.
button was pressed for
more than 25 seconds
or one of these
buttons is stuck.
Off Off Generator Two pumps are If two pumps are connected,
commun­ connected to the both pumps will go into low
ication SmartAblate™ RF (standby) flow. Disconnect one
Generator. pump from the generator.

or If only one pump is connected,

disconnect the pump
There is a connection cable from the
communication generator, reconnect it, and
problem with the wait 5 seconds. If the warning
SmartAblate™ RF occurs again, replace the
Generator. connection cable with a new
cable. If the problem persists,
operate the pump using the
pump user interface and
contact Customer Support.
Off Off none There is a problem Disconnect the cable and
with the connection reconnect it or turn the pump
cable from the off and on. If the problem
generator to the persists, operate the pump
pump. using the pump user interface
or the foot pedal and contact
Customer Support.
Off Off none There is a problem Disconnect the foot pedal and
with the foot pedal. reconnect it or turn the pump
off and on. If the problem
persists, operate the pump
using the pump user interface
or the generator interface and
contact Customer Support.
Off Off none The internal battery Contact Customer Support.
has low voltage.

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Irrigation Pump User Manual

6.2 Errors

Each error situation generates an alarm (see Section 7.9, Alarm Specifications).

AI = Alarm Indicator (see Item 7 in Section 3.1, Controls on the Front of the Pump)
BI = Bubble Indicator (see Item 16 in Section 3.1, Controls on the Front of the Pump)
Image AI BI Message Reason What To Do
Blinks Blinks Big A big bubble was !! Patient danger !!
red red bubble detected during high
(ablation) or low Immediately turn the 4-way
(standby) flow. stopcock on the SmartAblate™
Irrigation Tubing Set so that
the fluid is not routed to the
catheter. Then press the Stop
button on the pump. Be sure
to clear the bubble before
starting the flow, even if the
error message disappears.
(See Section 5.3, Flushing to
Eliminate Air in the Tubing
and Catheter.) Note: Opening
the door can move the tubing
slightly, causing the bubbles
to move out of the bubble
sensor area. Inspect the tubing
carefully!
Blinks Blinks Many Many small bubbles !! Patient danger !!
red red small were detected during
bubbles high (ablation) or low Immediately turn the 4-way
(standby) flow. stopcock on the SmartAblate™
Irrigation Tubing Set so that
the fluid is not routed to the
catheter. Then press the Stop
button on the pump. Be sure
to clear the bubbles before
starting the flow, even if the
error message disappears.
(See Section 5.3, Flushing to
Eliminate Air in the Tubing
and Catheter.) Note: Opening
the door can move the tubing
slightly, causing the bubbles
to move out of the bubble
sensor area. Inspect the tubing
carefully!

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Irrigation Pump User Manual

Image AI BI Message Reason What To Do

Blinks Off Flow rate The flow rate is lower Check for an interruption in the
red too low than the set rate. pump head rotation, such as a
Either there is an blocked fluid path in the tubing
interruption in the (pinched tubing) or damage to
pump head rotation the tubing in the pump head
or there is a hardware area. If an interruption is found,
failure. clear the interruption. If the
tubing is damaged, replace the
tubing. Then turn the pump
off and on. If the error persists,
contact Customer Support.
Blinks Off Button A button was pressed Turn the pump off and on. If the
red while the pump was error persists, contact Customer
powering on. Support.

Blinks Off Foot The foot pedal was Turn the pump off and on, then
red pedal pressed too gently or press the foot pedal again. If the
not in the center or the error occurs again, disconnect
foot pedal was pressed the foot pedal and connect
while the pump was a different foot pedal or try
powering on. operating the pump without the
foot pedal. If the error persists,
contact Customer Support.

6.3 System Errors

Each error situation generates an alarm (see Section 7.9, Alarm Specifications).

AI = Alarm Indicator (see Item 7 in Section 3.1, Controls on the Front of the Pump)
BI = Bubble Indicator (see Item 16 in Section 3.1, Controls on the Front of the Pump)
Image AI BI Message Reason What To Do
Blinks Off varies There is a system error. If you see this image with any
red message that is not listed in
Section 6.2, Errors, turn the
pump off and on. If the error
persists, contact Customer
Support.

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Irrigation Pump User Manual

6.4 Other Troubleshooting

Problem What To Do
The pump will not turn on. Verify that the power supply meets the specifications in Section 7.1,
Specifications, and then check to see whether a fuse is broken. If a fuse
is broken, replace it (see Section 3.6, Fuses). If the fuse is not broken or
if a new fuse breaks, call Customer Support.
On startup, the SmartAblate™ Press and hold the Stand-by button for approximately 3 seconds to
System logo does not appear, turn off the pump. Then press the Stand-by button again to turn the
the alarm and air bubble pump back on. If the problem persists, contact Customer Support.
indicators do not light, or there
is no audible tone.
The pump turns on when you The pump turns on automatically if it is connected to the
don’t want it on. SmartAblate™ RF Generator and the generator is turned on. Press the
Stand-by button on the pump to put the pump into sleep mode (see
Section 5.1, Turning the Pump On and Off ).

6.5 Determining the Pump’s Serial Number and Software Version

Customer Support may ask for the pump’s serial number and software version.

Options Screen

Serial number

Software version

Turn off the pump and close the pump door.

Press and hold the Low (Standby) Flow button while you briefly press the
Stand-by button. Release the Low (Standby) Flow button when the Options screen appears
displaying the serial number and software version.

Press the Stand-by button to remove the information from the screen. The pump will
turn off.

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7 Technical Data
7.1 Specifications

Mains
Voltage 100-120 V ± 10%
220-230 V ± 10%
Frequency 50/60 Hz
Power consumption 30 VA

Mode of Operation
Continuous operation

Flow Accuracy (up to 75 psi)

1 mL/min = -20% to +20%
2-5 mL/min = -10% to +20%
6-39 mL/min = -5% to +15%
40-60 mL/min = -10% to +20%
Flush (100 mL/min) = -10% to +20%

Bubble Detection
Designed to detect bubbles ≥ 2 µL

Adjustment of the Flow Rates (in 1 mL/min steps)

Low (Standby) Flow 1 mL/min - 5 mL/min
High (Ablation) Flow 6 mL/min - 30 mL/min (versions US and JP)
6 mL/min - 60 mL/min (version WW)

Maximum Infusion Pressure

115 psi

Sound Pressure Level for Error Messages

45 to 65 dB(A) (measured 1 m from pump)

Fuses
T500 mAH 250V

Other
Classifications Class I and defibrillation proof type CF (as defined in IEC/EN 60601-1)
Class IIa (as defined in MDD 93/42/EEC)
Class 3, FDA
Weight 5.5 kg
Dimensions 195 mm wide x 180 mm high x 235 mm long
IP rating IP54

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7.2 Storage and Shipping Conditions

Ambient temperature -30° to +65°C

Relative humidity 10% to 90% (non-condensing)
Atmospheric pressure 500 to 1060 mbar

7.3 Operating Conditions

Ambient temperature 10° to 40°C

Relative humidity 10% to 90% (non-condensing)
Atmospheric pressure 700 to 1060 mbar

7.4 Safety Inspections

Important Notice
To ensure the safety of the SmartAblate™ Irrigation Pump, repairs and safety inspections may
be performed only by the manufacturer, a service engineer certified by the manufacturer, or a
service center certified by the manufacturer. The safety inspections must be performed at least
once a year and after every repair, according to IEC/EN 60601‑1 and its sub‑standards and IEC/
EN 62353.

7.5 Maintenance

Inspect the pump before each use. Perform the following verifications.

• The High (Ablation) Flow and Low (Standby) Flow knobs are not loose and the values on
the screen change as expected when the knob is turned.
• None of the receptacles is damaged or loose.
• The potential equalization port is not damaged and is not loose.
• The mains cable is not damaged.
• The foot pedal is not damaged.

Once a year, perform the verifications listed above as well as those listed below.

• The device label is present and readable.

• The foot pedal functions correctly when tested with the SmartAblate™ Irrigation Pump.
• The flow rate is accurate. Follow the instructions for use provided with the SmartAblate™
Irrigation Pump Test Kit.
If desired, a service contract can be arranged. Contact Customer Support.

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7.6 Repairs

There are no parts in the SmartAblate™ Irrigation Pump that may be serviced by the user.
(Exception: The fuses may be replaced per Section 3.6, Fuses). Repairs or any changes to the
pump and the accessories must be performed only by the manufacturer, a service engineer
authorized by the manufacturer, or service centers certified by the manufacturer.

7.7 Conformance to Standards

The SmartAblate™ Irrigation Pump meets the requirements of the following standards.

Standard Title
CAN/CSA C22.2 Medical electrical equipment - Part 1: General requirements for safety
No. 601.1, B-90
CMDR Canadian Medical Devices Regulations
DIN EN 980 Symbols for use in the labeling of medical devices
DIN EN 1041 Information supplied by the manufacturer of medical devices
DIN EN ISO 14971 Medical devices - Application of risk management to medical devices
EU Dir. 2002/96/EC EU Directive 2002/96/EC of 27 January 2003 on waste electrical and electronic
equipment (WEEE)
EU Dir. 2006/66/EC Directive 2006/66/EC of the European Parliament and of the Council of 6
September 2006 on batteries and accumulators and waste batteries and
accumulators and repealing Directive 91/157/EEC
IEC 60812 Analysis techniques for system reliability - Procedure for failure mode and
effects analysis (FMEA)
IEC/EN 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance
IEC/EN 60601-1-1 Medical electrical equipment - Part 1-1: General requirements for safety -
Collateral standard: Safety requirements for medical electrical systems
IEC/EN 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety
and essential performance - Collateral standard: Electromagnetic compatibility -
Requirements and tests
IEC/EN 60601-1-4 Medical electrical equipment - Part 1-4: General requirements for safety -
Collateral Standard: Programmable electrical medical systems
IEC/EN 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety
and essential performance - Collateral standard: Usability
IEC/EN 60601-1-8 Medical electrical equipment - Part 1-8: General requirements for basic safety
and essential performance - Collateral Standard: General requirements, tests
and guidance for alarm systems in medical electrical equipment and medical
electrical systems
IEC/EN 60601-1-9 Medical electrical equipment - Part 1-9: General requirements for basic
safety and essential performance - Collateral Standard: Requirements for
environmentally conscious design

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Irrigation Pump User Manual

Standard Title
IEC/EN 62304 Medical device software - Software life cycle processes
IEC/EN 62353 Medical electrical equipment - Recurrent test and test after repair of medical
electrical equipment
IEC/EN 62366 Medical devices - Application of usability engineering to medical devices
MDD 93/42/EEC Medical Device Directive (MDD) Council Directive 93/42/EEC of 14 June 1993
/ MPG (Medical concerning medical devices
Products Law)
UL 60601-1 Medical electrical equipment - Part 1: General requirements for safety

7.8 EMC Information and Technical Description

The use of accessories, transducers and cables other than those specified, with the exception
of transducers and cables approved by the manufacturer of the SmartAblate™ Irrigation Pump
as replacement parts for internal components, may result in increased emissions or decreased
immunity of the SmartAblate™ Irrigation Pump.

Electromagnetic Emissions
The SmartAblate™ Irrigation Pump is intended for use in the electromagnetic environment specified
below. The customer or user of the SmartAblate™ Irrigation Pump should ensure that it is used in such an
environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions Group 1 The SmartAblate™ Irrigation Pump uses
CISPR 11 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 Class A
CISPR 11 The SmartAblate™ Irrigation Pump is suitable
for use in all establishments other than
Harmonic emissions Class A
domestic and those directly connected to the
IEC 61000-3-2
public low-voltage power supply network
Voltage fluctuations/flicker Complies that supplies buildings used for domestic
emissions purposes.
IEC 61000-3-3

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Electromagnetic Immunity
The SmartAblate™ Irrigation Pump is intended for use in the electromagnetic environment specified
below. The customer or user of the SmartAblate™ Irrigation Pump should ensure that it is used in such an
environment.

Immunity Test IEC 60601 Compliance Electromagnetic Environment - Guidance

Test Level Level
Electrostatic ± 6 kV contact ± 6 kV contact Floors should be wood, concrete, or ceramic
discharge (ESD) tile. If floors are covered with synthetic
IEC 61000-4-2 ± 8 kV air ± 8 kV air material, the relative humidity should be at
least 30%.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be that of a
transient/burst supply lines supply lines typical commercial or hospital environment.
IEC 61000-4-4
Surge ± 1 kV differential ± 1 kV differential Mains power quality should be that of a
IEC 61000-4-5 mode mode typical commercial or hospital environment.
± 2 kV common ± 2 kV common
mode mode
Voltage < 5% UT < 5% UT Mains power quality should be that of a
dips, short (> 95% dip in UT) (> 95% dip in UT) typical commercial or hospital environment.
interruptions for 0.5 cycle for 0.5 cycle If the user of the SmartAblate™ Irrigation
and voltage Pump requires continued operation
variations on 40% UT 40% UT
during power mains interruptions, it is
power supply (60% dip in UT) (60% dip in UT)
recommended that the SmartAblate™
input lines for 5 cycles for 5 cycles
Irrigation Pump be powered from an
IEC 61000-4-11 70% UT 70% UT uninterruptible power supply.
(30% dip in UT) (30% dip in UT)
Note that a 5 second removal of power, as
for 25 cycles for 25 cycles
tested, results in the device shutting down
< 5% UT < 5% UT and requires user intervention to restart.
(> 95% dip in UT) (> 95% dip in UT) There was no interruption of operation for
for 5 sec for 5 sec other tests.
Power frequency 3 A/m 3 A/m Power frequency magnetic fields should
(50/60 Hz) be at levels characteristic of a typical
magnetic field location in a typical commercial or hospital
IEC 61000-4-8 environment.
Note: UT is the AC mains voltage prior to application of the test level. The SmartAblate™ Irrigation Pump
was tested at 100 and 230 VAC.

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Electromagnetic Immunity
The SmartAblate™ Irrigation Pump is intended for use in the electromagnetic environment specified
below. The customer or user of the SmartAblate™ Irrigation Pump should ensure that it is used in such an
environment.

Immunity Test IEC 60601 Compliance Electromagnetic Environment - Guidance

Test Level Level
Conducted RF 3 Vrms 3V Portable and mobile RF communications
IEC 61000-4-6 150 kHz to equipment should be used no closer to any part
80 MHz of the SmartAblate™ Irrigation Pump, including
Radiated RF 3 V/m 3 V/m cables, than the recommended separation
IEC 61000-4-3 80 MHz to distance calculated from the equation applicable
2.5 GHz to the frequency of the transmitter.

Recommended separation distance:

d = 1.17 √ P 150 kHz to 80 MHz
d = 1.17 √ P 80 MHz to 800 MHz
d = 2.33 √ P 800 MHz to 2.5 GHz
where P is the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and d is the
recommended separation distance in meters (m).
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: At 80 MHz and 800 MHz, 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.
a
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 SmartAblate™ Irrigation Pump is used exceeds the applicable RF compliance level above, the
SmartAblate™ Irrigation Pump should be observed to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating the SmartAblate™
Irrigation Pump.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Recommended Separation Distances between Portable and Mobile RF Communications

Equipment and the SmartAblate™ Irrigation Pump
The SmartAblate™ Irrigation Pump is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or user of the SmartAblate™ Irrigation Pump
can help prevent electromagnetic interference by maintaining a minimum distance between portable
and mobile RF communications equipment (transmitters) and the SmartAblate™ Irrigation Pump as
recommended below, according to the maximum output power of the communications equipment.

Separation Distance According to Frequency of Transmitter (m)

Rated Maximum Output
Power of Transmitter (W) 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 1.17 √ P d = 1.17 √ P 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 7.38
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.

EMC Information and Technical Description

MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in this user manual.

Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL

EQUIPMENT.

Warning: The use of ACCESSORIES, transducers, and cables other than those specified, with
the exception of transducers and cables approved by the manufacturer of the SmartAblate™
Irrigation Pump as replacement parts for internal components, may result in increased
EMISSIONS or decreased IMMUNITY of the SmartAblate™ Irrigation Pump.

Warning: The SmartAblate™ Irrigation Pump may be operated in the immediate vicinity of
the SmartAblate™ RF Generator. However, do not operate the pump in the immediate vicinity of
devices that are not approved for electromagnetic compatibility (EMC) with the pump. If such
operation is unavoidable, regularly monitor the pump to ensure proper functioning.

Warning: The SmartAblate™ Irrigation Pump may be interfered with by other equipment,
even if that other equipment complies with CISPR EMISSION requirements.

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Irrigation Pump User Manual

The following instructions must be followed to avoid disturbance of the measurement quality:

• The SmartAblate™ Irrigation Pump may be operated only with cables specified by the
manufacturer.
• The SmartAblate™ Irrigation Pump must be connected with the grounding cable to a
separate grounding point.
• All devices in the patient area that are connected to the SmartAblate™ Irrigation Pump must
be on the same mains.
• All devices in the patient area that are connected to the SmartAblate™ Irrigation Pump must
be connected to separate ground points with their own grounding cables.
7.9 Alarm Specifications

After an alarm event occurs, there may be a delay of not more than 500 ms before the related
sound, light, and/or message are produced.

AI = Alarm Indicator (see Item 7 in Section 3.1, Controls on the Front of the Pump)
BI = Bubble Indicator (see Item 16 in Section 3.1, Controls on the Front of the Pump)

Reset
No. Event Tone AI BI Action Comments
1 The > low Pulse pattern: none Off Off none Information
(standby) tone
flow, >> high Tone frequency:
(ablation) flow, 2 kHz ± 20%
>>> flush flow, or Tone on: 25 ms
Stop button was
pressed
2 The foot pedal Pulse pattern: none Off Off none Information
was pressed. tone
Tone frequency:
2 kHz ± 20%
Tone on: 25 ms
3 The foot pedal Pulse pattern: none Off Off none Information
was released. tone
Tone frequency:
2 kHz ± 20%
Tone on: 25 ms
4 High (ablation) Pulse pattern: none Off Off none Information
flow was started tone
from generator Tone frequency:
(does not apply 2 kHz ± 20%
to SmartAblate™ Tone on: 25 ms
RF Generator).
5 High (ablation) Pulse pattern: none Off Off none Information
flow was stopped tone
from generator Tone frequency:
(does not apply 2 kHz ± 20%
to SmartAblate™ Tone on: 25 ms
RF Generator).

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Reset
No. Event Tone AI BI Action Comments
6 “Door open” Pulse pattern: none On, red Off Close Information
message door. alarm
Tone frequency:
2 kHz ± 20%
Tone on: 25 ms
7 “Big bubble” Pulse pattern: Blinks Blinks Press High priority
message ti-ti-ti--ti-ti----------ti-ti-ti- red red Stop alarm
-ti-ti button.
2Hz, 2Hz,
Tone frequency: 40% on 40% on
910 Hz ± 20% (± 20%) (± 20%)
Tone pause: 10 s
8 “Many small Pulse pattern: Blinks Blinks Press High priority
bubbles” message ti-ti-ti--ti-ti----------ti-ti-ti- red red Stop alarm
-ti-ti button.
2Hz, 2Hz,
Tone frequency: 40% on 40% on
910 Hz ± 20% (± 20%) (± 20%)
Tone pause: 10 s
9 “Motor direction” Pulse pattern: Blinks Off none High priority
message ti-ti-ti--ti-ti----------ti-ti-ti- red alarm
-ti-ti
2Hz,
Tone frequency: 40% on
910 Hz ± 20% (± 20%)
Tone pause: 10 s
10 “Flow not zero” Pulse pattern: Blinks Off none High priority
message ti-ti-ti--ti-ti----------ti-ti-ti- red alarm
-ti-ti
2Hz,
Tone frequency: 40% on
910 Hz ± 20% (± 20%)
Tone pause: 10 s
11 Other errors Pulse pattern: Blinks Off none High priority
(examples: ti-ti-ti--ti-ti----------ti-ti-ti- red alarm
“Flow rate too -ti-ti
low,” “Foot 2Hz,
pedal,” “Motor Tone frequency: 40% on
power supply” 910 Hz ± 20% (± 20%)
messages) Tone pause: 10 s

Note: All alarms are technical alarms.

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8 Symbols
Symbol Description

SmartAblate™ Irrigation Pump

Distributed by The device is distributed by

Manufactured by The device is manufactured by

Quantity

Follow operating instructions

Upper and lower temperature limits (storage and shipping conditions)

Upper and lower humidity limitation (storage and shipping conditions)

Upper and lower atmospheric pressure limitation (storage and shipping

conditions)

Keep dry

All patient connections of the device are defibrillation-proof type CF applied parts

Lot number

Catalog number

Alarm

Rotational adjustment. Clockwise rotation increases value.

Flow direction

Potential equalization port

Foot pedal receptacle

COMM Communication connector (to generator, for example)

Sensor receptacle

Fuses
Alternating current

8 Symbols | Page 32
Irrigation Pump User Manual

Symbol Description

Manufacturer

Manufacturing date

Serial number

Japanese version of the SmartAblate™ Irrigation Pump

United States version of the SmartAblate™ Irrigation Pump

Worldwide version of the SmartAblate™ Irrigation Pump (except the United States,
Japan, and China)
Medical – General medical equipment as to electrical shock, fire and mechanical
hazards only in accordance with UL 60601-1 / CAN/CSA C22.2 NO. 601-1 / ANSI/
AAMI ES60601-1 (2005) / CAN/CSA C22.2 NO. 60601-1 (2008)
40GF

Caution

Follow operating instructions

Made in Germany Certificate of origin in Germany

CE marking with the number of the notified body

Separate collection for electrical and electronic equipment

The device does not contain phthalates

The device is latex-free

The device may be damaged by electrostatic discharge (ESD) if a person without

ESD protection touches a COMM receptacle. Do not touch without appropriate
ESD protection.
The device is protected against dust and is protected against splashing water

Hardware revision number

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9 Warranty
9.1 Transit Damage

The SmartAblate™ Irrigation Pump and accessories must be examined for transit damage
immediately after receipt. If the pump and accessories are damaged, notify Customer Support.
Damage claims can be validated only if the seller or the shipping agent is informed immediately.
For your convenience, an “Error Report” form is shipped with the pump; you can use this form to
record any damage.

9.2 Warranty

The warranty for the SmartAblate™ Irrigation Pump warrants that the pump will conform to its
product specifications for a period of one year from the date of shipment or for the period of time
defined in the purchase contract. Exceptions to the warranty are accessories, connection cables,
and disposable parts. Repairs or any changes may be performed only by the manufacturer,
a service engineer authorized by the manufacturer, or a service center authorized by the
manufacturer. The warranty is voided if improper modifications or repairs are performed. The
warranty is not extended or renewed by services performed under warranty.

9.3 Product Liability

Product liability is assumed by STOCKERT GmbH under the following conditions:

• The pump has been operated only with original STOCKERT GmbH accessories (see Chapter 4,
Accessories).
• Repairs to the pump and to the accessories have been performed only by the manufacturer,
a service engineer authorized by the manufacturer, or a service center authorized by the
manufacturer.

9 Warranty | Page 34
Irrigation Pump User Manual

Manufactured By
STOCKERT GmbH
Bötzinger Straße 72
79111 Freiburg, Germany
Fax: +49-761-20716-20
Email: [email protected]
http://www.stockert.de

Customer Support – In USA

Biosense Webster, Inc.
Tel: +1-866-4SERVCE (+1-866-473-7823) (toll free in USA)
Email: [email protected]

Customer Support – Outside USA

Biosense Webster
Tel: +32-2-7463-463
Email: [email protected]

Distributed By
Outside USA In USA
Biosense Webster Biosense Webster, Inc.
A Division of Johnson & Johnson Medical NV/SA 3333 Diamond Canyon Road
Leonardo da Vincilaan 15 Diamond Bar, California 91765 USA
1831 Diegem, Belgium Tel: +1-866-473-7823
Tel: +32-2-7463-401 Fax: +1-909-468-2786
Fax: +32-2-7463-403 http://www.biosensewebster.com

Carto®, Celsius®, NaviStar®, SmartAblate™, and ThermoCool® are trademarks of Biosense Webster,
Inc. The third party trademarks listed herein are trademarks of their respective owners.

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

SmartAblate™ Irrigation Pump

Firmware 1.XX

© Biosense Webster, Inc. 2012-2013

January 2013


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