SYMBOLS
Caution: In the United States of America, Federal
law restricts this device to sale by, or on the order
of, a physician.
Consult instruction for use (Consulter les instruc-
tions d'utilisation)
Warning (Avertissement)
Caution (Attention)
Curtis Strauss NRTL mark
Potential for electromagnetic interference
Fuse
Protective earth ground
Standby
Type B applied part (Partie appliquée de type B)
Temperature limits (Température limite)
Humidity Limits (Humidité limite)
Pressure Limits (Pression limite)
Manufacturer (Manufacture)
Date of Manufacture (Date de Manufacture)
Pinch Point (Pincer)
Correct tubing placement to bag
(Placement de tube correct au panier)
Alternating Current (Courant alternative)
Serial Number (Numéro de série)
Catalogue Number (Numéro de catalogue)
ABBREVIATIONS
A Amperes
Hz Hertz
SN Serial Number
V Volts
INDICATIONS FOR USE
The I Supply RenovaRP®Paracentesis Pump is intended as
a suction pump to remove ascetic fluid from the abdominal
cavity in conjunction with the I Supply Paracentesis Kit.
The I Supply RenovaRP®Paracentesis Pump is intended to
be used by medically trained healthcare professionals
knowledgeable about paracentesis.
CONTRAINDICATIONS
Paracentesis procedures should not be performed on patients
with clinically apparent disseminating intravascular coagula-
tion and oozing from needle sticks or primary fibrinolysis until
bleed risk is reduced. Paracentesis should not be performed
on patients with a massive ileus with bowel distension unless
the procedure is image guided.
ARNINGS
●
CAUTION: In the United States of America, Federal
law restricts this device to sale by, or on the order of, a
physician.
●This pump is not intended for infusion or dialysis pro-
cedures.
●
Avoid dangerous environments. This is a class I, Type B
device. It has no protection against the ingress of fluids.
Electrical instruments designed to process liquids must
be operated with extreme caution. If liquid comes in con-
tact with internal electrical components or wiring, fire or
electric shock may occur. Do not operate electrical
equipment in a combustible atmosphere. Do not oper-
ate in an O2enriched environment. The pump is not
suitable for use in the presence of flammable anesthetic
mixtures with air or with oxygen or nitrous oxide.
●Ground the equipment. To avoid risk of electric
shock, this equipment must only be connected to a
supply mains with protective earth.
●Avoid potential electromagnetic interference.
If this product is used with EMI sensitive equipment,
care should be taken to prevent possible interference.
●The use of accessories other than those specified for the
device is not recommended. They may result in in-
creased emissions or decreased immunity of the device.
●The device should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is nec-
essary, the device should be observed to verify normal
operation in the configuration in which it will be used.
PRECAUTIONS
●Know your equipment. Read the manual care-
fully and learn the device’s operation and limitations
before use.
●Use location: Always place pump in a location where
the power cord is easily accessible if disconnection of
the device is required.
●Avoid accidental start up. Always make sure that the
switch is in the standby position before plugging
the pump into the proper outlet.
●Disconnect instrument. Always disconnect the instru-
ment from the power source before servicing.
●Maintain instrument with care. Keep unit clean.
Inspect the plug and cord before each use. Do not
operate this device if there are signs of damage.
●Leakage: Although the system is closed, there is the
potential for leakage to occur. Should leakage occur
refer to the cleaning section of this manual for appro-
priate cleaning.
●Proper Tube Loading: All connections should be
checked for tightness and tubing checked for pinching,
twisting or stretching prior to starting pump.
●Specification of the Applied Part: The Pump Tubing
set found within the I Supply Paracentesis kit is the
Applied Part.
DESCRIPTION
The I Supply RenovaRP®Paracentesis Pump is a portable,
reusable suction pump designed to remove ascetic fluid
from the abdominal cavity in a manner that is both rapid
and convenient. The pump is used with the I Supply Para-
centesis Kit, which includes the needle and sheath for access
to the abdominal cavity and the tubing with attached
drainage bags for removal of the fluid during treatment.
When used as intended with the I Supply Paracentesis Kit,
the pump is capable of removing fluid at a maximum rate
of approximately 600ml/min.
An easily opened compartment is located on the front of the
pump for positioning of the tubing; posts are located on each
side of the pump for hanging the drainage bags. Operation
of the pump is initiated with a control knob on the front
panel. The pump requires no tools to load or remove the
tubing and drainage bags.
OPERATION
CAUTION: ONLY USE THE I SUPPLY PARACENTESIS KIT
WITH THE PUMP. USE OF OTHER PARACENTESIS KITS MAY
RESULT IN INADEQUATE PUMP OPERATION AND FLUID
REMOVAL.
1. LOAD TUBING
●Position control knob to Standby Mode.
CAUTION: BE SURE PUMP DRIVE IS IN STANDBY
MODE ( ) BEFORE LOADIN TUBIN . SERIOUS INJURY
MAY RESULT IF FIN ERS ARE INSERTED INTO THE PUMP
ROTOR DURIN OPERATION.
●Lift the flip top track until fully open.
●Remove the pump tubing from the I Supply Paracen-
tesis Kit tray and fit section of larger OD tubing across
the pumphead rotor.
CAUTION: ENSURE THAT THE SECTION OF TUBIN
LEADIN FROM THE PATIENT ENTERS THE LEFT SIDE OF
THE PUMPHEAD AND EXITS ON THE RI HT SIDE TO THE
DRAINA E BA S. (See Figure 1)
●Lower the flip top track ensuring that the tubing is
fitted correctly between the rollers and track and that
there is no pinching of the tubing by the tube clamps.
The tubing must lie naturally againsts the track and
must not be kinked, twisted or stretched.
●Press the T-shaped stopcock assembly into the recessed
area of the handle.
●Place a fluid drainage bag on the posts located on each
side of the pump and attach the bags to the pump
tubing set. (See Figure 2)
2. START PUMP
●With the control knob in the standby position, en-
sure the power cord is plugged into the device and the
grounding plug is inserted into the proper grounding
type receptacle.
●Ensure that the pump tubing is attached to the Para-
centesis Device and that the stopcock is in the OPEN
position.
●Ensure that the T-shaped stopcock in the handle recess
is OPEN for flow to ONE of the drainage bags and is
CLOSED for flow to the second bag.
●Ensure that the drainage bag clamp is in the OPEN
position.
●Set the pump to the desired speed output using the
control knob which is calibrated to provide speed
control within 0 to 100% of maximum speed. The green
LED will illuminate when the unit is operating and out
of standby position.
●With the provided I Supply Paracentesis Kit, the max-
imum setting (100%) will deliver a flow rate of approx-
imately 600 ml/min. If a slower rate is desired, the
control knob may be reduced to the desired flow rate.
3. CHANGE DRAINAGE BAGS
●When the drainage bag is full of fluid, open the
stopcock to the empty drainage bag. As the second
bag begins to fill, close the stopcock of the full bag.
●Close the clamp on the tubing to the full bag and
detach the bag from the tubing assembly.
●Additional bags can be added to the closed tubing
assembly side as needed.
4. COMPLETION OF THE PROCEDURE
●At the completion of the procedure, ensure the control
knob is turned to standby position.
Figure 1
Flip-top track
Larger OD tubing section From patient
To drainage
bags
Larger OD
tubing section
Recessed area
of handle
LED
indicator light
Standby/
Pump
speed
control
Drainage
bag
Open/Close al e
Posts
T-shaped
stopcock
assembly
Figure 2
IMMUNITY
TEST
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
Portable and mobile RF com-
munications equipment
should be used no closer to
any part of the product, in-
cluding cables, than the rec-
ommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter.
Recommended separation
distance:
d=1.2√P
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3√P 800 MHz to 2.5 Hz
where P is the maximum out-
put power rating of the trans-
mitter in watts (W) and
according to the transmitter
manufacturer and d is the rec-
ommended separation dis-
tance in meters(m)
Field strengths from fixed RF
transmitters, as determined
by and electromagnetic site
survey,a“should be less than
the compliance level in each
frequency range.b
Interference may occur in the
vicinity of equipment marked
with the following symbol:
Compliance
Level
Electromagnetic
environment-guidance
The product is intended for use in the electromagnetic environment specified
below. The customer or the user of the product should assure that it is used in such
an environment.
Note 1 At 80 MHz and 800 MHz, the higher frequency range applies
Note 2 These guidelines may not apply in all situations. Electromagnetic propa-
gation is affected by absorption and reflection from structures, objects and people
aField strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accu-
racy. 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 product is used exceeds the applicable RF compli-
ance level above, the product should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such
as re-orienting or relocating the product.
bOver the frequency range of 150 kHz to 80 MHz, field strengths should be less
than 3 V/m
Guidance and manufacturer’s declaration –electromagnetic immunity
IEC 60601
test level
3 Vrms
3 V/m
3Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 Hz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
The product is intended for use in an electromagnetic environment in which radi-
ated RF disturbances are controlled. The customer or the user of the product can
help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and
the product as recommended below, according to the maximum output power of
the communications equipment.
For transmitters rated at a maximum output power not listed above, the recom-
mended 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 to 800 MHz, the separation distance for the higher frequency
range applies.
NOTE 2 These guidelines may not apply to all situations. Electromagnetic propaga-
tion is affected by absorption and reflection from structures, objects and people.
Recommended separation distances between portable and mobile
RF communications equipment and the product
Separation distance according to fre uency of transmitter
Rated maximum
output power of
transmitter 80 MHz to 800 MHz
d=1.2√P
800 MHz to 2.5 Hz
d=2.3√P
150 kHz to 80 MHz
d=1.2√P
REF
SN
Luer-Lock
Cap
Pinch
Clamp
