GI Supply RenovaRP User manual

Paracentesis Pump
RenovaRP®
OPERATING MANUAL

• The use of accessories other thanthose specified for the device is not recommended.
They may result in increasedemissions or decreased immunity of the device.
• The device shouldnot be used adjacent to or stacked with other equipment. If
adjacent orstacked use isnecessary, the device should be observed to verify normal
operation inthe configuration in which it will be used.
PRECAUTIONS
• Know your equipment. Read the manual carefully 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 instrument 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 isthe potential for leakage to occur.
Shouldleakage occur refer to the cleaning section of this manual for appropriate
cleaning.
• Proper Tube Loading: All connections should be checked for tightening and tubing
checked for pinching, twisting or stretching prior to starting pump.
• Specification of the Applied Part: The RenovaRP Tube Set found withinthe
RenovaRP Paracentesis Kit is the Applied Part.
DESCRIPTION
The GI Supply RenovaRP Paracentesis Pump is a portable, reusable peristaltic pump
designed to remove ascitic fluid from the abdominal cavity in a manner that is both
rapidand convenient. The pump is intended to be used in conjunction with the
RenovaRP Paracentesis Kit and RenovaRP Fluid Drainage Bags.
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 RenovaRP PARACENTESIS KIT WITH THE PUMP. USE
OF OTHER PARACENTESIS KITS MAY RESULT IN INADEQUATE PUMP OPERATION
AND FLUID REMOVAL.
• 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 twisted or
stretched.
• Press the T shaped stopcock assembly into the recessed area of the handle.
• Place a RenovaRP Fluid Drainage Bag onthe posts located on each side of the
pump and attach the bags to the stopcock assembly. (See Figure 2)
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 instructions d’utilisation)
Warning (Avertissement)
Caution
Curtis Strauss NRTL mark
Potential for elecromagnetic interference
Fuse
Protective earth ground
Standby
Type B applied part (Partie appliquée de type B)
Temperature limits (Température limite)
Manufacturer (Manufacture)
Date of Manufacturer (Date de Manufacture)
Pinch point (Pincer)
Correct tubing placement to bag (Placement de tube correct au panier)
Alternating Current (Courant alternative)
Serial Number (Numero de serie)
Catalogue Number (Numero de catalogue)
ABBREVIATIONS
A Amperes
Hz Hertz
SN Serial Number
V Volts
INDICATIONS FOR USE
The GI Supply RenovaRP® Paracentesis Pump is intended as a peristaltic pump
to remove ascitic fluid from the abdominal cavity in conjunction with the
GI Supply RenovaRP Paracentesis Kit. The GI 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 coagulation 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.
WARNINGS
• CAUTION: In the United States of America, Federal law restricts this device to
sale by, or on the order of, aphysician.
• This pump is not intended for infusion ordialysis procedures.
• Avoiddangerous environments. This is a class I, Type B device. It has noprotection
againstthe ingress of fluids. Electricalinstruments designed to process liquids
mustbe operated with extreme caution. If liquid comes in contact with internal
electrical components or wiring, fire orelectric shock may occur. Do not operate
electricalequipment in a combustible atmosphere. Do not operate in an O₂ enriched
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
onlybe connected to a supply mains with protective earth.
• Avoidpotential electromagnetic interference. If this product is usedwith EMI
sensitive equipment, care should be taken to prevent possible interference.
P
aracentesis Management System
SN
REF
CAUTION: CLINICIAN MUST USE PPE AND HANDLING PROCEDURES FOR BIOHAZARD
WASTE ACCORDING TO FACILITY PROTOCOLS.
1. LOADTUBING
• Position control knob to Standby Mode.
• CAUTION: BE SURE PUMPDRIVE IS IN STANDBY MODE ( )BEFORE LOADING
TUBING. SERIOUS INJURY MAY RESULT IF FINGERS ARE INSERTED INTO THE PUMP
ROTOR DURING OPERATION. PUMPIS IN STANDBY MODE WHEN PLUGGED IN AND
CONTROL KNOB TURNED TOTHE STANDYBY POSTION. GREEN LED WILL NOT BE
ILLUMINATED.
• Lift the flip top track until fully open.
• Remove the pump tubing from the RenovaRP Paracentesis Kit and fit section of large
diameter tubing across the pumphead rotor.
CAUTION: ENSURE THATTHE SECTION OFTUBING LEADING FROMTHE PATIENT
ENTERSTHE LEFT SIDE OF THE PUMPHEAD AND EXITS ON THE RIGHT SIDE TO THE
DRAINAGE BAGS. (See Figure 1)

2. START PUMP
• With the control knob in the standby position, ensure the power cord is pluggedinto the
device andthe grounding plug is inserted into the proper grounding type receptacle.
• Ensure that the RenovaRP Tube Set is attached to the catheter.
• Ensure that the T shaped stopcock in the handle recess is OPEN for flow to ONE of the drainage
bags and isCLOSED 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 the standby position.
• The control knob may be adjusted to a achieve 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.
• Replace filled bag with another empty bag and redirect fluid as needed.
4. COMPLETION OFTHE PROCEDURE
• At the completion of the procedure, ensure the control knob is turned to standby.
• Ensure both sides of the T shaped stopcock are closed. Close the clamp on the tubing to the full
bag and detach the bag from the tube set.
• Remove the used tubing and drainage bags. Dispose of according to facility protocol for
biohazard waste.
Figu
re 1
Flip - top track
Large diameter tubing section Patient
To T-shaped stopcock
assembly and drainage bags
FIGURE 1
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 GHz
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 an 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 customerorthe userofthe product should assure that it isused in such
an environment.
Note 1 At 80 MHz and 800 MHz,the higherfrequency 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
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 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.
b
Over 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 GHz
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 frequency of transmitter
Rated maximum
output power of
transmitter 80 MHz to 800 MHz
d=1.2√P
800 MHz to 2.5 GHz
d=2.3√P
150 kHz to 80 MHz
d=1.2√P
FIGURE 2
Tom
h
Open/Close valve
Large diameter
tubing section
Drainage bag
LED indicator light
Standby/Pump
speed control
T-shaped
stopcock
assembly
Luer-Lock Cap
Posts
Recessed area
of handle
Pinch Cl amp
50
Tome asure small volume
holdthis line horizontal
Open
Close

Manufactured by: 5069 Ritter Road, Suite 104, Mechanicsburg, PA 17055 USA • 1-800-451-5797
[e-mail] • www.gi-supply.com
©2019 GI Supply. All rights reserved.
RenovaRP® is a registered trademark
of GI Supply, Inc
900332 Rev 06
P
aracentesis Management System
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Compliance
Group 1
Class B
Class A
Complies
Electromagnetic environment - guidance
The product uses RF energy only for its inter-
nal function. Therefore,its RF emissions are
very low and are not likely to cause any inter-
ference in nearby electronic equipment
The product is intended for use in the electromagnetic environment specified
below.The customer orthe user of the product should assure that itis used in such
an environment.
Guidance and manufacturer’s declaration – electromagnetic emissions
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 interrup-
tions and volt-
age variations
on power sup-
ply input lines
IEC 61000-4-11
Power
frequency
50/60 Hz)
magnetic field
Floors should be wood,
concrete, or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should
be at least 30%
Mains power quality
should be that of a typi-
cal commercial or hospi-
tal environment
Mains power quality
should be that of a typi-
cal commercial or hospi-
tal environment
Mains power quality
should be that of a typi-
cal commercial or hospi-
tal environment. If the
user of the product re-
quires continued opera-
tion during power mains
interruptions,it is recom-
mended that the prod-
uct be powered from an
uninterruptible power
source.
Power frequency mag-
netic fields should be at
levels characteristic of a
typical location in a typi-
cal commercial or hospi-
tal environment.
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 isused in such
an environment.
Note UT is the AC mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration –electromagnetic immunity
IEC 60601
test level
+6kV contact
+8kV air
+2kV for power
supply lines
3 A/m
+1kV lines to line
+2kV line 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 cycles
<5% UT
(>95% dip in UT)
for 5 s
+6kV contact
+8kV air
+2kV for power
supply lines
3 A/m
+1kV lines to line
+2kV line 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 cycles
<5% UT
(>95% dip in UT)
for 5 s
The product is suitable for use in all establish-
ments other than domestic, and maybe used
in domestic establishments andthose di-
rectly connected to the public low-voltage
power supply network that supplies
buildings used for domestic purposes,
provided the following warning is heeded:
Warning: This equipment/system is intended
for useby healthcare professionals only. This
equipment/system may cause radio interfe-
rence or may disrupt the operation of nearby
equipment. It may be necessary to take miti-
gation measures, such as re-orienting or re-
locating theproduct or shielding thelocation.
All medical electronic devices, including this product, must
conform to the requirements of IEC 60601-1-2. Precautions,
adherences to the EMC guideline information provided
in this manual and verification of all medical devices
in simultaneous operation are required to ensure the
electromagnetic compatibility and co-existence of all other
medical devices prior to any procedure.
The EMC tables below are provided for your reference.
CLEANING
CAUTION: USE OF AN UNAPPROVED
CLEANING SOLUTION OR METHOD MAY RESULT
IN DAMAGETOTHE PUMP. USE ONLY APPROVED
PRODUCTS AND FOLLOW THE GUIDELINES
BELOW.
The RenovaRP® Paracentesis Pump housing and
tubing track may be cleaned with commonly used
solutions, such as:
• Isopropyl alcohol
• Mild detergent and warm water
Unplug the pump before cleaning. Use
sterilization wipes or spray the cleaning agent on a
soft wipe, paper towel, or equivalent material. Do
not use excessive amounts of fluid or spray fluid
directlyon any part of the pump. After cleaning,
dry the pump with a soft cloth to remove any
cleaning residues.
Do not apply cleaning solutions to the electrical
connections. Do not sterilize the pump.
CAUTION: DO NOT SUBMERGE THE PUMP IN
FLUID.
If a spill does occur, the control knob should
be turned to standby and the instrument
disconnected from the power source before
cleaning. Any spillage into the base can be
cleaned by removing the 4 screws located on the
underside of the base using ahex or flat head
screw driver. Additional disinfection of the pump
should be performed per institutional guidelines.
Following disinfection, replace the base and
securely tighten all4 screws to the underside
of the base. It is recommended that a drop of
medium strength thread locker be added to each
of the screws before re-inserting.
MAINTENANCE
The speed control circuit has solid-state
components which donot require service. An
excessive load on the system may, however, cause
afuse to blow. An indication of this would be that
with power applied to the drive and the control
knob turned on, the power indicator LED does
not light. If this condition does occur, fuses are
located onthe back of the pump housing. If found
defective replace with afuse of the same type and
rating (5x20mm, F2.5A250V). This information is
printed on the back of the unit.
STORAGE AND OPERATION
Store and operate the pump at room temperature
in a clean environment away from high humidity.
SERVICE AND REPAIR
WARNING: No modification of this equipment
is allowed.
Operation of the RenovaRP Paracentesis Pump
for removal of ascitic fluid from the abdomen
requires no installation and no routine service.
Information on replacement parts and servicing
may be obtained by contacting GI Supply at 1-800-
451-5797. Items returned must be authorized by
GI Supply.
The expected service life of the pump is7-10 years.
Disposal of the RenovaRP Paracentesis Pump
should be done in accordance with institution
guidelines for equipment.
SPECIFICATIONS
Physical Specifications
Dimensions: 13 x9 x 13 in (33 x23 x33cm)
Weight: 8.5lbs (3.9kg)
Functional Specifications
Power Specifications:
Input current: 2.5A
Input Voltage: 100- 230V~
Input Frequency: 50/60Hz
Power Cord: Hospital Grade power cord
IEC 60601-1 General Requirements for Safety
This device is BV approved WITH RESPECTTO
ELECTRICAL SHOCK, FIRE AND MECHANICAL
HAZARDSONLY IN ACCORDANCE WITH UL60601-
1:2003/CAN/CSA C22.2 No. 60601-1-08
This device meets the requirements of EN-60601-1:
2005+A1:2012 so as to conform to the Medical
Device Directive 93/42/EEC and 2007/47/EC
(general safety information)
This product complies to the above standards only
when used with the supplied accessories.