
Manufactured by: 5069 Ritter Road, Suite 104, Mechanicsburg, PA 17055 USA • 1-800-451-5797
orders@gi-supply.com • www.gi-supply.com
©2019 GI Supply. All rights reserved.
RenovaRP® is a registered trademark
of GI Supply, Inc
900332 Rev 06
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.