Riptide™
Aspiration Pump
TABLE OF CONTENTS
Riptide™ Aspiration Pump
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English en
CANISTER HOLDER
TUBING
ASPIRA
COLLECTION CANISTER
User’s Manual
Riptide™ Aspiration Pump
110-115VAC, 60Hz
100VAC, 50/60Hz
VACUUM CONTROL
KNOB
VACUUM GAUGE
ON/OFF BUTTON
POWER CORD CONNECTION
Figure 1: Riptide™ Aspiration Pump Features and Controls
TION PUMP
Figure 2: Riptide™ Aspiration Pump and Riptide™ Collection Canister with
DESCRIPTION
• The Riptide™ Aspiration Pump is an externally powered electromechanical device
capable of generating a vacuum designed for drawing uids and small particles into
the Riptide™ Collection Canister during neurovascular interventional procedures. It
is intended for clinical and catheter lab use and is not intended for transport or eld
applications.
• The recommended operating range for the Riptide™ Aspiration Pump is between 20-25
inHg (68-85 kPa).
• The Riptide™ Aspiration Pump is intended for use as a component of the Riptide™
Aspiration System. The Riptide™ Aspiration System includes the Arc™ Catheter, React™
68 Catheter, React™ 71 Catheter, Riptide™ Aspiration Tubing, Riptide™ Large Bore
Aspiration Tubing, Riptide™ Aspiration Pump, and Riptide™ Collection Canister with
Intermediate Tubing.
• Federal law (USA) restricts this device and other components of the Riptide™ Aspiration
System to sale by or on the order of a physician.
• The Riptide™ Aspiration Pump package includes the following:
o Riptide™ Aspiration Pump
o Region specic power cords for connection to earthed receptacle. Select correct
cord from included kit.
o Riptide™ Aspiration System Instructions for Use
o Riptide™ Aspiration Pump User’s Manual
• Required for use with Riptide™ Aspiration System (packaged separately)
o Arc™ Catheter, Applied Part
o React™ 68 Catheter, Applied Part
o React™ 71 Catheter, Applied Part
o Riptide™ Aspiration Tubing, Applied Part
o Riptide™ Large Bore Aspiration Tubing, Applied Part
o Riptide™ Aspiration Pump
o Riptide™ Collection Canister with Intermediate Tubing
Intermediate Tubing
POTENTIAL EQUALIZATION PLUG
VACUUM INLET
COOLING AIR INTAKE
INTERMEDIATE
INDICATIONS AND CONTRAINDICATIONS
• Refer to the Riptide™ Aspiration System Instructions for Use for indications and
contraindications.
OPERATING DESCRIPTION
VACUUM GAUGE
VACUUM CONTROL
KNOB
Figure 3: Riptide™ Aspiration Pump Internal Composition
The Riptide™ Aspiration Pump uses an industry proven oilless rocking piston type vacuum
pump. A single, permanent split capacitor type electric motor powers a two-stage pump
arrangement that provides high vacuum and ecient ow through the Riptide™ Collection
Canister. In a reciprocating motion, a exible cup mounted on top of a wristless piston and
connecting rod in each stage creates vacuum as the cup creates a vacuum as a result of the
rocking motion. The vacuum is drawn in through the vacuum inlet and exhausted internally
in the enclosure where it is mixed with cooling air and discharged through a vent located
on the bottom.
ON/OFF BUTTON
VACUUM INLET
EXHAUST
TWO-STAGE PUMP
PUMP MOTOR
COOLING AIR EXHAUST
WARNINGS
• The Riptide™ Aspiration System in contact with patients should only be used
by physicians who have received appropriate training in interventional neuroendovascular techniques and treatment of acute ischemic stroke. The Riptide™
aspiration tubing, Riptide™ Aspiration Pump, and Riptide™ Collection Canister with
Intermediate Tubing are designed for setup by clinical support sta under the
supervision of a trained physician.
• Do not use the Riptide™ Aspiration System with components other than the Arc™
Catheter, React™ 68 Catheter, React™ 71 Catheter, Riptide™ Aspiration Tubing,
Riptide™ Large Bore Aspiration Tubing, Riptide™ Aspiration Pump, and Riptide™
Collection Canister with Intermediate Tubing.
• The Riptide™ Aspiration Pump is a Class I Medical Equipment. To avoid the risk of
electric shock, this equipment must only be connected to a supply mains with
protective earth.
PRECAUTIONS
• The Riptide™ Aspiration Pump and the Riptide™ Collection Canister with Intermediate
Tubing are supplied non-sterile and are intended for use outside of the sterile eld
only.
• Do not use the Riptide™ Aspiration Pump without the Riptide™ Collection Canister with
Intermediate Tubing connected to the vacuum inlet.
• The Riptide™ Aspiration Pump is intended for use only with the Riptide™ Collection
Canister with Intermediate Tubing. The lid is equipped with integral overow
protection and a biological lter required for safe and correct operation in the Riptide™
Aspiration System. Using non-validated canisters, lters, or systems may result in
improper patient connections, uid overow, biological contamination, and nonrepairable damage of the Riptide™ Aspiration Pump.
• Do not allow aspirated uids, overow, or other liquids into the Riptide™ Aspiration
Pump. This will cause non-repairable damage to the pump and create biological
contamination. Pumps so contaminated must be removed from service and disposed
of in accordance with standard biological waste disposal procedures in eect.
• The Riptide™ aspiration tubing and Riptide™ Collection Canister with Intermediate
Tubing are single use only.
• The Riptide™ Aspiration Pump does not contain any user serviceable part inside. Do not
attempt to open the enclosure.
• Do not use in presence of explosive atmospheres, ammable liquids or anesthetic
mixtures, and nitrous oxide.
• Do not use in oxygen enriched environment.
SETUP
• Remove the Riptide™ Aspiration Pump from storage and/or its packaging (if present)
and visually inspect for damage.
• Place the Riptide™ Aspiration Pump on a rigid, stable, at, horizontal surface outside of
the sterile eld, within reach of the Riptide™ aspiration tubing and providing sucient
tubing slack to the patient table.
• The Pump should be placed so that the tubing connections, controls and gauges are
visible and accessible to the operator. The Riptide™ Aspiration Pump must never be
positioned in a manner that makes it dicult to operate.
• Locate the Riptide™ Aspiration Pump such that a minimum of 6 inches clearance exists
in all directions to adjacent objects or other common cath lab equipment, powered
or un-powered.
• Do not block the air vents located on the back and bottom of the enclosure. Do not
place the pump on thick or plush absorbent table covering and do not cover the pump
with poly or other sheeting during operation. Blocked air ow will result in pump
overheating.
• Attach the correct end of the supplied power cord to the power connection on the back
of the enclosure. Press in rmly and conrm its solid positioning.
• If required, attach the potential equalization connector to the potential equalization
plug identied by a green/yellow disk located at the back of the pump.
• Conrm that the mains power is available and the pump’s nameplate ratings are
compatible.
• The device power cord is the isolation means and is detachable from the Riptide™
Aspiration Pump. The cord’s appliance connector is an IEC60320 C13 type and dierent
from the mains connector. Use only the correct power cord intended for the region.
To connect the device, push the cord’s C13 plug into the C14 type appliance power
inlet plug located at the back of the enclosure. At the other cord end, insert the mains
plug into the designated mains power receptacle. NOTE: The Riptide™ Aspiration Pump
should not be positioned such that it is dicult to disconnect the supplied power cord.
• The Riptide™ Aspiration Pump’s power cable should not be bundled or held in
proximity with other power cables that may carry very large surges and transients
such as welders and large electric motors. In addition, separation from data cables
and communications lines should follow EN50174-2:2008. In general, approximate
separation from unshielded lines should be no less than 2 feet, separation for shielded
cables 2 inches. Failure to follow these guidelines may result in electromagnetic
interference due to radiated or re-radiated electrical noise.
• Check the basic operation of the Riptide™ Aspiration Pump by pressing the ON/OFF
power switch on the front panel. The switch should light up green and pump motor
should start. The presence of vacuum can be conrmed by temporarily blocking the
vacuum inlet with a nger and operating the pump’s vacuum control knob while
observing the vacuum gauge. Note that the tethered cap is not a vacuum seal and
may not seal air tight without additional nger pressure on top. Turn the pump o by
pressing the ON/OFF power switch before proceeding.
• Do not use the Riptide™ Aspiration Pump for aspiration without the Riptide™ Collection
Canister with Intermediate Tubing connected to the vacuum inlet.
• Obtain a new Riptide™ Collection Canister with Intermediate Tubing and perform the
setup in accordance with the Riptide™ Aspiration System Instructions for Use and the
Riptide™ Collection Canister with Intermediate Tubing Quick Reference Guide.
• The Riptide™ Aspiration Pump is now ready to connect to Riptide™ aspiration tubing per
the Riptide™ Aspiration System Instructions for Use.
OPERATION
• Refer to the Riptide™ Aspiration System Instructions for Use and the Riptide™ Collection
Canister with Intermediate Tubing Quick Reference Guide to conrm complete setup
for aspiration.
• With the Arc™ Catheter or React™ 68 Catheter, or React™ 71 Catheter, Riptide™
Aspiration Tubing, Riptide™ Large Bore Aspiration Tubing, Riptide™ Aspiration Pump,
and Riptide™ Collection Canister with Intermediate Tubing connected, the Riptide™
Aspiration Pump is ready to begin supplying vacuum to the connected components.
• Conrm that the ow control switch on the Riptide™ aspiration tubing is in the OFF
position.
• The ON/OFF power switch on the control panel is a push button that requires moderate
force inward to activate and de-activate. When depressed to the ON position, the
button will lock in the recessed position, the green symbol will light, and the pump
will begin to operate. When the button is depressed again, the button will return to
the original ush position, the green symbol will go dark, and pump will cease to run.
• At any time when the power switch is turned OFF after the Riptide™ Aspiration Pump
is run, any vacuum present in the system will be released and the Riptide™ Collection
Canister with Intermediate Tubing, and Riptide™ aspiration tubing proximal to the ow
control switch will return to ambient conditions in a few seconds.
• Press the ON/OFF power switch on the Riptide™ Aspiration Pump control panel and
conrm that the power switch button lights, the pump motor starts and produces a
steady hum.
• Allow it to run for at least one minute. Conrm normal operation and the presence of
vacuum as indicated on the gauge.
• Using the vacuum control knob on the Riptide™ Aspiration Pump, adjust the vacuum
to a reading of minimum 20 inHg but not exceeding 25 inHg on the gauge. Adjust
the vacuum by rotating the vacuum control. To increase the vacuum, turn the knob
clockwise. To decrease the vacuum, turn the knob counter-clockwise.
• Note that it is normal for the indicator needle of the gauge to oscillate or vibrate in
response to pump pulsation. Allow the range of the needle to stabilize and adjust the
vacuum control so that the midpoint of the motion aligns with the desired setting.
• The Riptide™ Aspiration System is now ready to aspirate.
• During the procedure, monitor the vacuum level indicated on the gauge. It is normal
for the needle to drift about the desired set point as use conditions change. The
vacuum level may drop as a result of turning the Riptide™ aspiration tubing ow
control switch on, opening a tubing connection or exchanging a catheter. The vacuum
level will recover to its set point when the ow control switch is returned to OFF or
when the tubing or catheter connection is restored.
• During the procedure, monitor the uid level that may have collected in the canister.
It is recommended that the uid not be allowed to ll more than about 75% of the
capacity. Should this occur, the physician should have the Riptide™ Collection Canister
with Intermediate Tubing changed out.
• At the conclusion of the aspiration procedure, turn o the Riptide™ Aspiration Pump by
pressing the ON/OFF power switch. The green light on the switch will go out and the
pump will stop producing a humming noise.
• The Arc™ Catheter, React™ 68 Catheter, React™ 71 Catheter, Riptide™ Aspiration
Tubing, Riptide™ Large Bore Aspiration Tubing and Riptide™ Collection Canister with
Intermediate Tubing are single use only. Remove and discard in accordance with
standard biological waste disposal procedures in eect.
• Disconnect the power cord from the mains.
CLEANING
• Place the attached tethered cap over the vacuum inlet prior to cleaning.
• Disconnect the power cord from the pump and clean separately if required.
• The outside of the Riptide™ Aspiration Pump enclosure may be cleaned by wiping
down with 70% IPA and common non-bleach, non-solvent, clinical surface cleaning
agents, e.g. Diversey Virex Tb (ready-to-use) or equivalent. Wipe dry before storage.
• Do not use cleaning agents containing petroleum base solvents, acids, caustics,
chlorinated solvents.
• The Riptide™ Aspiration Pump is not compatible with any sterilization procedures
including ETO, e-beam, gamma, and autoclave.
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