Medtronic MAP-1000 Instructions for Use

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 specic 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 ecient 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 overow
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 overow, biological contamination, and non­repairable damage of the Riptide™ Aspiration Pump.

• Do not allow aspirated uids, overow, 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 eect.

• 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 sucient
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 dicult 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 conrm its solid positioning.

• If required, attach the potential equalization connector to the potential equalization
plug identied by a green/yellow disk located at the back of the pump.

• Conrm 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 dierent
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 dicult 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 conrmed 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 conrm 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.

• Conrm 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
conrm that the power switch button lights, the pump motor starts and produces a
steady hum.

• Allow it to run for at least one minute. Conrm 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 eect.

• 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.

3

• Do not attempt to disassemble the pump other than removing the cord and Riptide™
Collection Canister with Intermediate Tubing.

• Do not immerse the Riptide™ Aspiration Pump in water or cleaning solutions or use a
ooding rinse as a cleaning method.

• Do not inject, spray or otherwise introduce water, IPA, or cleaning agents into the
cooling air intake louvers or exhaust vents located on the bottom.

• Never inject, spray, aspirate, or otherwise introduce cleaning or decontamination
agents into the vacuum inlet. The pump is designed only for air contact and the
introduction of any liquids or solids will cause non-repairable damage to internal
components.

• If the Riptide™ Aspiration Pump is known to have ingested uids during a procedure
it should be considered as contaminated and treated in accordance with standard
biological waste procedures in eect. No approved cleaning methods exist for internal
decontamination.

STORAGE

• Place the tethered cap over the vacuum inlet to prevent entry of dust and other
contaminants.

• The Riptide™ Aspiration Pump may be stored in a clean warehouse or storeroom
commonly used for clinical and lab supplies. See characteristics below for
environmental limits.

• The pump does not have an applicable “Use-by date”. However, after extended storage
it is recommended that it be cleaned, examined for damage, and tested for basic
functionality prior to its introduction in to a clinical setting.

TROUBLESHOOTING

• No user serviceable parts are inside the pump. Do not modify the pump or open the
enclosure.

• Use the troubleshooting chart below to determine common causes and recommended
remedies.

• Riptide™ Aspiration Pump Fuses – replace only with exact equivalent F 5A H 250V, UL
listed 5 x 20mm.

PROBLEM POSSIBLE CAUSE ACTION

Pump has
mechanical
damage to
enclosure,
gauges, controls

Power cord or a
plug on the cord
damaged

Power
connection on
pump enclosure
damaged

Pressing ON
power switch
causes mains
breaker to trip
or mains fuse
to blow

ON power switch
does not light
when pushed,
pump does
not run

Improper handling,
dropping, mechanical
damage

Improper handling, misuse,
mechanical damage

Improper handling, misuse,
mechanical damage

Internal electrical failure Replace pump

Mains power not connected Plug pump into receptacle

Cord not connected to
appliance power inlet

Loose cord at back of unit Press in or adjust cord in back of

Bad power cord Replace power cord

Mains power source is bad
or incorrect voltage

Pump fuse blown Replace fuse(s)

Mains supply breaker not on
or mains fuse blown

On power switch not
pushed hard enough

Internal mechanical or
electrical failure

Replace pump

Discard and do not repair a
damaged power cord. Do not
use cords intended for use in
regions other than local or
use electrical plug adapters or
converters to achieve a connection.
Doing so may result in damage
to the Riptide™ Aspiration
Pump and violate electrical
safety requirements. Required
replacement power cords vary by
region and certied commercial
assemblies are readily available.
The cords must meet the
applicable specications listed in
the CHARACTERISTICS table herein.

Replace pump

Plug cord into enclosure’s
appliance power inlet plug

enclosure

Plug pump into correct receptacle

Use only exact equivalent. F 5A
H250V, UL listed 5 x 20mm.

Turn on mains supply or replace
fuse

Press again

Replace pump

PROBLEM POSSIBLE CAUSE ACTION

ON power switch
does not light
but pump starts
and appears
operating
normally

ON power switch
lights when
pushed but
pump makes no
noise

ON power switch
lights and pump
starts briey
but switch does
not remain
depressed

ON power switch
lights when
pushed and
cooling fan on
bottom runs
but pump does
not run

Pump runs but
has abnormal
operation:
unusually loud,
high vibration,
running very hot,
burning smell,
smoke

Gauge needle
vibrates
excessively

Gauge needle
indicates vacuum
greater than 30
inHg or is pegged
fully counter­clockwise when
running

Pump runs
but no or
low vacuum
indicated at
gauge, vacuum
may be present
at Riptide™
aspiration
tubing

Faulty ON power switch Complete procedure if required but

Internal electrical failure or
faulty ON power switch

Faulty ON power switch Replace pump

Overheated motor due to
operation at full load for an
extended period or blocked
cooling vents

Pump contaminated by
aspiration overow

Internal mechanical or
electrical failure

Pump rocking - not sitting
on level surface with
all 4 feet

Cooling air intake and/or
bottom exhaust is blocked

Pump contaminated by
overow

Pump connected to
improper mains voltage
supply

Internal electrical or
mechanical damage or
failure

Vacuum pressure set too
low – especially below
15 inHg.

Faulty gauge if needle
does not stabilize at full
vacuum.

Faulty or damaged gauge. Use vacuum control knob to

Vacuum control knob not
adjusted

Faulty gauge Use vacuum control knob to

Flow control switch on
Riptide™ aspiration tubing
not set correctly

replace pump at rst opportunity

Replace pump

Turn pump o and allow time to
cool down. Remove any absorbent
padding or plastic sheeting
blocking pump air vents.

Replace pump.
Units contaminated with bio
uids should be disposed of in
accordance with standard hospital
biohazard procedures.

Replace pump

Re-position pump on at, rigid,
horizontal surface

Re-position pump. Do not place
pump on plush absorbent padding
or cover with splash sheeting.

Replace pump.
Units contaminated with bio
uids should be disposed of in
accordance with standard hospital
biohazard procedures.

Replace pump with unit that
matches mains power input

Replace pump

Increase vacuum between 20-25
inHg. It is normal for the indicator
needle of the gauge to oscillate
or vibrate in response to pump
pulsation, especially at minimal
vacuums.
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.

Procedure may be continued at
physician’s discretion but replace
pump at rst opportunity

attempt to set vacuum to
recommended range of 20-25
inHg. Procedure may be continued
at physician’s discretion but replace
pump at rst opportunity

Adjust knob to set vacuum to
desired level

attempt to set vacuum to
recommended range of 20-25
inHg. Procedure may be continued
at physician’s discretion but replace
pump at rst opportunity

Adjust ow control switch to OFF

PROBLEM POSSIBLE CAUSE ACTION

Pump runs
with vacuum
indicated at
gauge, but
no vacuum
at Riptide™
aspiration tubing
distal end

Pump runs but
low suction
or insucient
vacuum in
Catheter

Pump contaminated by
overow, pump seizing

Internal electrical or
mechanical damage or
failure

Loose, leaking, or missing
Intermediate Tubing

Flow control switch in OFF
position

Riptide™ Collection Canister
lid loose or drain port open

Riptide™ Collection Canister
not vertical and secured in
Riptide™ Aspiration Pump
receptacle

Riptide™ Collection Canister
bio-lter plugged

Plugged or kinked tubing Straighten or replace tubing

Broken canister, defective
connector or vacuum tubing

Riptide™ Collection Canister
full or foaming. Overow
protection valve has
activated and stopped ow

Riptide™ aspiration tubing
ow control switch set
incorrectly

Defective or broken Riptide™
aspiration tubing ow
control switch

Loose, leaking, or missing
Intermediate Tubing

Loose canister lid, vacuum
leak

Canister dump/vent port is
open or leaking

Pinched or kinked connector
or suction tubing

Incorrect vacuum control
knob setting

Incorrect ow control
switch setting

Flow control switch on
tubing defective

Canister bio lter is clogged
or overow valve is closed

Vacuum leak internal to
pump enclosure

Canister is full and overow
protection working
normally

Pump contaminated by
canister overow or liquid
ingress from previous
procedure

Replace pump

Replace pump

Install tubing correctly and check
ttings

Move switch to ON position

Tighten lid, close port with
tethered cap

Turn o the Riptide™ Aspiration
Pump and place the Riptide™
Collection Canister in the
receptacle, and restart the Riptide™
Aspiration Pump

Replace the Riptide™ Collection
Canister. Do not attempt to clean
or bypass lter.

Replace with a new Riptide™
Collection Canister with
Intermediate Tubing and Riptide™
aspiration tubing

Replace the Riptide™ Collection
Canister. Do not attempt to bypass
overow valve.

Set ow switch to desired setting

Replace the Riptide™ aspiration
tubing

Install tubing and check ttings

Reposition and press lid closed

Close dump/vent port with
tethered cap on lid

Straighten connector or suction
tubing

Adjust vacuum control knob to
proper setting

Adjust ow control switch to
proper setting – OFF to build
vacuum, ON to direct vacuum
to catheter

Replace the Riptide™ aspiration
tubing

Replace the Riptide™ Collection
Canister. Do not attempt to clean
or bypass lter.

Replace pump

Replace the Riptide™ Collection
Canister.
Do not attempt to clean or bypass
canister.
Dispose of full canister in
accordance with standard hospital
biohazard procedures.

Replace pump.
Do not attempt to clean or
decontaminate pump.
Pump units contaminated with
bio uids should be disposed of in
accordance with standard hospital
biohazard procedures.

4

PROBLEM POSSIBLE CAUSE ACTION

Vacuum
indicated on
gauge does
not respond
to change in
vacuum control
setting

Pump
spontaneously
stops running or
is intermittent
during use

Pump does not
shut o when
switch is pushed

Riptide™
Collection
Canister does
not t in the
receptacle of
the Riptide™
Aspiration
Pump

Tubing does
not t correctly
on Riptide™
Aspiration Pump
vacuum inlet

MAINTENANCE

• Operating life: The Riptide™ Aspiration Pump has an operating life of 500 hours.

• The enclosure does not contain any user serviceable parts inside and should not be
opened.

• Fuses: Located at the back of the unit. Replace only with exact equivalent F 5A H 250V,
UL listed 5 x 20mm.

• Sterilization: The Riptide™ Aspiration Pump is NOT designed to be sterilized by
autoclaving, chemical means (such as ETO and other sterilant compounds), or
radiation. Any attempt to do so will cause non-repairable damage to the unit.

DISPOSAL

• Riptide™ Aspiration Pump with mechanical/electrical failure or normal wear-out:
Dispose of non-functioning pumps in accordance with standard hospital procedures
for electromechanical equipment.

• Riptide™ Aspiration Pump with contamination by aspirated uid ingress: Dispose of in
accordance with standard hospital biohazard procedures.

• 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. Dispose of in accordance with standard
hospital biohazard procedures.

Faulty vacuum control knob
or faulty vacuum gauge

Internal electrical or
mechanical damage or
failure

Loss of mains power,
breaker interruption, power
surge, brownout

Power cord disturbed, loose Re-plug power cord securely to

Blown Riptide™ Aspiration
Pump fuse

Pump overheated due to
long continuous running in
poor cooling

Riptide™ Collection Canister
overowed and uid
ingress has seized pump

Attempted use of non­validated canister without
lters; uid ingress causing
pump to seize

Incorrect tubing connection
for the Riptide™ aspiration
tubing connected directly to
vacuum inlet of the Riptide™
Aspiration Pump bypassing
the Riptide™ Collection
Canister

Internal electrical or
mechanical damage or
failure

Switch not pushed hard
enough

Faulty switch or internal
electrical failure

Attempted use of non­validated canister system.

Attempted use of non­validated canister and/
or tubing

Attempted connection of
the Riptide™ aspiration
tubing directly to the
vacuum inlet of the Riptide™
Aspiration Pump

Replace pump

Replace pump

Restore mains power or connect to
uninterruptable power supply.

mains and pump enclosure

Replace fuse(s)
Use only exact equivalent F 5A H
250V, UL listed 5 x 20mm.

Allow pump to cool, correct
cooling air ow blockage, and
restart

Replace Riptide™ Aspiration Pump
and Riptide™ Collection Canister

Replace Riptide™ Aspiration Pump.
Use correct Riptide™ Collection
Canister
Pump may be biological hazard

Replace pump.
Pump may be biological hazard

Replace pump

Press again

Pull mains plug to un-power.
Replace pump

Replace with Riptide™ Collection
Canister with Intermediate Tubing

Replace with Riptide™ Collection
Canister with Intermediate Tubing

Review the Riptide™ Aspiration
System Instructions for Use.
Install the Riptide™ Collection
Canister and connect the Riptide™
aspiration tubing to the port
labeled “PATIENT” on the Riptide™
Collection Canister.

CHARACTERISTICS

Characteristic Value

Model Riptide™ Aspiration Pump MAP-1000

Vacuum Range, Nominal 0-29 inHg (0-98kPa)

Vacuum Gauge +/- 5% of full scale value

Flow Rate, Nominal 0-0.8SCFM (0-23 LPM)

Power Input Rating 110-115VAC, 60Hz, 500VA max.

Overcurrent Protection (Fuses) F 5A H 250V, UL listed 5 x 20mm

Approximate Dimensions Length – 16.1” (40.9cm)

Weight Approximately 24lbs (11kg)

Duty Cycle Non-continuous

Operating Conditions Temperature: 65 to 75F (18 to 24ºC)

Storage Conditions Temperature: -25 to 125ºF (-32 to 52ºC)

Enclosure Ingress Rating IP21 (Drip Tight)

Power Cord, North America Rating: 10A, 125VAC

Power Cord, Japan Rating: 12A, 125VAC

100VAC, 50/60Hz, 700VA max.

Depth – 13.2” (33.5cm)
Height – 12.3” (31.2cm)

97% (58.2 minutes on, 1.8 minutes o)

Humidity 20-80% non-condensing
Air pressure: 24-31 inHg (81-105kPa)

Humidity: 5-90% non-condensing
Air pressure: 20-31 inHg (68-105 kPa)

Length: 10 feet (3.05m)
General: UL62, CSA 22.2.no.49
Type: Hospital grade, UL817, CSA
C22.2 no. 21
Mains plug: NEMA 5-15 (IEC type B),
green dot
Appliance plug: IEC60320 C13
Cable type: SJT
Conductors: 3, AWG18 minimum
Conductor color code: IEC60446

Length: 2.5m (~8.2feet)
General: JIC C 3005
Type: Hospital grade, JIS T 1021, “H” mark
Mains plug: JIS8303 (IEC type B-Japan),
green dot
Appliance plug: IEC60320 C13
Cable type: VCTF
Conductors: 3, 1.25mm minimum
Conductor color code: IEC60446

ELECTRICAL SAFETY

General IEC60601-1:2012 General standard, Medical devices

Earthbond IEC60601-1:2012

Leakage Current IEC60601-1:2012

ELECTROMAGNETIC COMPATIBILITY

The Riptide™ Aspiration Pump is expected to be relatively unaected by common
electromagnetic (EM) disturbances. In the event of unusual or extraordinary EM events
beyond the limits, it is possible that device may exhibit a loss of Essential Performance (the
ability to generate the necessary vacuum required for aspiration as set by the user). Should
this occur, discontinue use of the device. The Riptide™ Aspiration Pump is intended for use in
electromagnetic environments as specied below.

0.2 ohm max.

Type BF, Class I Medical Equipment

Guidance and Manufacturer’s Declarations

Guidance and Manufacturer’s Declaration –

The Riptide™ Aspiration Pump is intended for use in the electromagnetic environment
specied below. The customer or the user of the pump should make sure that it is used in
such an environment.

Emissions Test Compliance Electromagnetic Environment

RF Emissions
CISPR 11

Electromagnetic Emissions

- Guidance

Group 1 The Riptide™ Aspiration Pump

may use 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.

Emissions Test Compliance Electromagnetic Environment

RF Emissions
CISPR 11

Harmonic Emissions
IEC 61000-3-2

Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3

Class B The Riptide™ Aspiration

Complies

Complies

- Guidance

Pump is suitable for use in all
establishments other than
domestic and those directly
connected to the public low­voltage power supply network
that supplies buildings used for
domestic purposes.

Guidance and Manufacturer’s Declaration –

Electromagnetic Immunity

The Riptide™ Aspiration Pump is intended for use in the electromagnetic environment
specied below. The customer or the user of the pump should make sure that it is used in
such an environment.

Immunity

Test

Electrostatic
Discharge
(ESD)

IEC 61000-4-2

Electrical Fast
Transient/
Burst
IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage
Dips, Short
Interruptions,
and Voltage
Variations on
Power Supply
Lines
IEC 61000­4-11

Power
Frequency
(50/60 Hz)
Magnetic
Field
IEC 61000-4-8

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Conducted RF
IEC 61000-4-6

IEC 60601
Test Level

±6 kV contact
±8 kV air

±2 kV for power
supply lines
±1 kV for input/
output lines

±1 kV line(s) to
line(s)
±2 kV line(s) to
earth

<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 cycle
<5% UT (>95%
dip in UT) for 5
seconds

3 A/m Complies Mains power quality should

3V rms
150 kHz to 80 MHz

Compliance

Level

Complies The Riptide™ Aspiration

Complies Mains power quality should

Complies Mains power quality should

Complies Mains power quality

Complies

Electromagnetic

Environment - Guidance

Pump should not be aected
by electrostatic discharge
that might occur under
normal conditions of use.

It is recommended that
oors should be wood,
concrete or ceramic tile.
If oors are covered with
synthetic material, the
relative humidity should be
at least 30%.

be similar to that of a typical
commercial or hospital
environment.

be similar to that of a typical
commercial or hospital
environment.

should be similar to that
of a typical commercial
or hospital environment.
If the user of the Riptide™
Aspiration Pump requires
continued operation during
power mains interruptions,
it is recommended that
the Riptide™ Aspiration
Pump be powered from an
uninterruptible power supply
or a battery.

be similar to that of a typical
commercial or hospital
environment.

Portable and mobile RF
communications equipment
should be used no closer
to any part of the Riptide™
Aspiration Pump than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.

Recommended separation
distance

5

Radiated RF
IEC 61000-4-3

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

aected by absorption, and reection from structures, objects and people.

a

Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV
broadcast cannot be predicted theoretically with accuracy. To access the electromagnetic
environment due to xed RF transmitters, an electromagnetic site survey should be
considered. If the measured eld strength in the location in which the Riptide™ Aspiration
Pump is used exceeds the applicable RF compliance level above, the pump should be observed
to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orienting or relocating the pump or the transmitting device from which
it is receiving signals.
b

Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

3V/m
80 MHz to 6 GHz

Complies d = 1.2 √P 80 MHz-800 MHz

d = 2.3 √P 800 MHz-6 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 xed RF
transmitters, as determined
by an electromagnetic site
survey, a should be less than
the compliance level in each
frequency range.
Interference may occur in the
vicinity of equipment marked
with the following symbol:

b

Recommended separation distances between portable and

mobile RF communications equipment and the Riptide™

Aspiration Pump

This section provides information on the recommended separation distance between
portable and mobile RF communications equipment and the Riptide™ Aspiration Pump. The
Riptide™ Aspiration Pump is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the pump users can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the pump as recommended below,
according to the maximum output power of the communications equipment.

Rated Maximum
Output Power of
Transmitter (W)

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.74

1 1.2 1.2 2.3

10 3.8 3.8 7.4

100 12 12 23

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

aected by absorption, and reection from structures, objects and people.

WARRANTY DISCLAIMER

Although this product has been manufactured under carefully controlled conditions, the
manufacturer has no control over the conditions under which this product is used. The
manufacturer therefore disclaims all warranties, both expressed and implied, with respect to
the product including, but not limited to, any implied warranty of merchantability or tness
for a particular purpose. The manufacturer shall not be liable to any person or entity for any
medical expenses or any direct, incidental or consequential damages caused by any use,
defect, failure or malfunction of the product, whether a claim for such damages is based upon
warranty, contract, tort or otherwise. No person has any authority to bind the manufacturer
to any representation or warranty with respect to the product. The exclusions and limitation
set out above are not intended to, and should not be construed so as to contravene mandatory
provisions of applicable law. If any part or term of this Disclaimer of Warranty is held illegal,
unenforceable or in conict with applicable law by a court of competent jurisdiction, the
validity of the remaining portions of this Disclaimer of Warranty shall not be aected, and all
rights and obligations shall be construed and enforced as if this Disclaimer of Warranty did not
contain the particular part or term held to be invalid.

Separation Distance According to the Frequency of

150 kHz to

80 MHz

d = 1.2√P

Transmitter (m)

80 MHz to

800 MHz

d = 1.2√P

800 MHz to

6 GHz

d = 2.3√P

6

S

www.medtronic.com/manuals

IP21

REF

N

ymbol Glossary

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

Consult instructions for use at this website.

Caution

Follow Instructions for Use

Keep dry

Type BF Applied Part

S

CONTENTS

NON

STERILE

Serial number

Date of manufacture

Contents of Package

Non-sterile

Equipotentiality

Dangerous voltage

Ingress Protection Marking (IP Code per IEC60529)
Protection against vertically dripping water drops

Catalogue number

Manufacturer

E491532

Stand-by

Variability, rotational adjustment

UL Certication
MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARDS ONLY
IEC 60601-1 Edition 3.1 (2012)/EN 60601-1:2016 + A1:2013 + A12:2014
ANSI/AAMI ES 60601-1:A1: 2012, C1: 2009/(R) 2012 and A2: 2010/(R) 2012, CSA CAN/
CSA-C22.2 NO. 60601-1:14

7

Medtronic, Medtronic with logo and Medtronic logo are U.S. and internationally registered trademarks of Medtronic.

© 2019 Medtronic.

Micro Therapeutics, Inc.
d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
USA
Tel: [phone]

M998301ADOC2 Rev. A (09/2019)