GI Supply RenovaRP Operating Manual

All medical electronic devices, including this product, must
conform to the requirements of IEC 60601-1-2. Precau-
tions, 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.
Guidance and manufacturer's declaration – electromagnetic emissions
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.
Emissions test Compliance Electromagnetic environment - guidance
The product uses RF energy only for its inter-
RF emissions nal function. Therefore, its RF emissions are
Group 1
CISPR 11 very low and are not likely to cause any inter-
ference in nearby electronic equipment
The product is suitable for use in all establish-
ments other than domestic, and may be used
RF emissions
Class B
in domestic establishments and those di-
CISPR 11
rectly connected to the public low-voltage
power supply network that supplies building
used for domestic purposes, provided the fol-
lowing warning is heeded:
Harmonic emissions
Class A
IEC 61000-3-2 Warning: This equipment/system is intended
for use by healthcare professionals only. This
equipment/system may cause radio interfer-
ence or may disrupt the operation of nearby
Voltage fluctuations/ equipment. It may be necessary to take mit-
Complies
flicker emissions igation measures, such as re-orienting or re-
IEC 61000-3-3
locating the product or shielding the
location.
Guidance and manufacturer's declaration –electromagnetic immunity
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.
IMMUNITY IEC 60601 Compliance Electromagnetic
TEST test level Level environment-guidance
Floors should be wood,
concrete, or ceramic tile.
Electrostatic
+6kV contact +6kV contact If floors are covered with
discharge (ESD)
+8kV air +8kV air synthetic material, the
IEC 61000-4-2
relative humidity should
be at least 30%
Mains power quality
Electrical fast
+2kV for power should be that of a typi-
+2kV for power
transient/burst
supply lines cal commercial or hospi-
supply lines
IEC 61000-4-4
tal environment
Mains power quality
should be that of a typi-
Surge +1kV lines to line +1kV lines to line
+2kV line to earth cal commercial or hospi-
IEC 61000-4-5 +2kV line to earth
tal environment
<5% UT <5% UT Mains power quality
(>95% dip in UT) (>95% dip in UT) should be that of a typi-
For 0,5 cycle For 0,5 cycle cal commercial or hospi-
tal environment. If the
Voltage dips,
40% UT
40% UT
user of the product re-
short interrup-
(60% dip in UT)
(60% dip in UT)
quires continued opera-
tions and volt-
For 5 cycles
For 5 cycles
tion during power mains
age variations
70% UT 70% UT interruptions, it is recom-
on power sup-
(30% dip in UT) (30% dip in UT) mended that the prod-
ply input lines
For 25 cycles For 25 cycles uct be powered from an
IEC 61000-4-11
uninterruptible power
<5% UT
<5% UT
source.
(>95% dip in UT)
(>95% dip in UT)
for 5 s
for 5 s
Power frequency mag-
Power
netic fields should be at
frequency
levels characteristic of a
3 A/m 3 A/m
50/60 Hz)
typical location in a typi-
magnetic field cal commercial or hospi-
tal environment.
Note UT is the AC mains voltage prior to application of the test level.
and no routine service. Information on replacement parts
Ensure both sides of the T-shaped stopcock are closed.
and servicing may be obtained by contacting GI Supply
Close the clamp on the tubing to the full bag and
detach the bag from the tubing assembly. at 1-800-451-5797. Items returned must be authorized by
GI Supply.
Remove the used tubing and drainage bags. Dispose of
The expected service life of the pump is 7-10 years. Disposal
according to facility protocol for biohazard waste.
of the GI Supply RenovaRP
CLEANING done in accordance with institution guidelines for equipment.
SPECIFICATIONS
CAUTION: USE OF AN UNAPPROVED CLEANING SOLU-
TION OR METHOD MAY RESULT IN DAMAGE TO THE PUMP.
Physical Specifications
USE ONLY APPROVED PRODUCTS AND FOLLOW THE GUIDE-
Dimensions: 13 x 9 x 13 in (33 x 23 x 33cm)
LINES BELOW.
Weight: 8.5 lbs (3.9kg)
The GI Supply RenovaRP ® Paracentesis Pump housing and
Functional Specifications
tubing track may be cleaned with commonly used solutions,
such as: Power Specifications
Input current: 2.5A
Isopropyl alcohol
Input Voltage: 100- 230V~
Mild detergent and warm water Input Frequency: 50/60Hz
Power Cord: Hospital Grade power cord
Unplug the pump before cleaning. Use sterilization wipes or
spray the cleaning agent on a soft wipe, paper towel, or equiv-
Environmental Specifications
alent material. Do not use excessive amounts of fluid or spray
Operation Conditions:
fluid directly on any part of the pump. After cleaning, dry the
Temperature: 15°C to 30°C
pump with a soft cloth to remove any cleaning residues. Relative Humidity: 30-75%
Atmospheric Pressure: 50-106kPa
Do not apply cleaning solutions to the electrical connections.
Do not sterilize the pump. Storage Conditions:
Temperature: 15°C to 30°C
CAUTION: DO NOT SUBMERGE THE PUMP IN FLUID.
Relative Humidity: 30-75%
If a spill does occur, the control knob should be turned to
Atmospheric Pressure: 50-106kPa
standby and the instrument disconnected from the
IEC 60601-1 General Requirements for Safety
power source before cleaning. Any spillage into the base
This device is BV approved WITH RESPECT TO ELECTRICAL
can be cleaned by removing the 4 screws located on the
SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN AC-
underside of the base using a hex or flat head screw driver.
CORDANCE WITH UL60601-1:2003/CAN/CSA C22.2 No.
Additional disinfection of the pump should be performed
60601-1-08
per institutional guidelines. Following disinfection, replace
the base and securely tightened all 4 screws to the under-
This device meets the requirements of EN-60601-1:
side of the base.
2005+A1:2012 so as to conform to the Medical Device Direc-
tive 93/42/EEC and 2007/47/EC (general safety information)
MAINTENANCE
This product complies to the above standards only when
used with the supplied accessories.
The speed control circuit has solid-state components which
do not require service. An excessive load on the system may,
however, cause a fuse to blow. An indication of this would
WARRANTY
be that with power applied to the drive and the control
knob turned on, the power indicator LED does not light. GI Supply warrants this product to be free from defects in
material and workmanship for a period of ninety (90)
If this condition does occur, fuses are located on the back
days from the date of shipment. If repair or adjustment is
of the pump housing. If found defective replace with a fuse
necessary within the warranty period which has not been the
of the same type and rating (5x20mm, F2.5A250V). This
result of mishandling or abuse, you may return the unit
information is printed on the back of the unit.
freight prepaid, provided that return authorization has been
STORAGE AND TRANSPORTATION obtained. GI Supply will correct the defect or adjust the unit
at no charge.
Store the pump at room temperature in a clean environ-
ment away from high humidity. Handle with care when
transporting.
SERVICE AND REPAIR
WARNING: No modification of this equipment is allowed.
200 Grandview Avenue • Camp Hill, PA 17011 USA
1-800-451-5797 • 717-761-0216 fax
Operation of the GI Supply Paracentesis Pump for removal
www.gi-supply.com
of ascetic fluid from the abdomen requires no installation
GIS0670001 Rev.03
® Paracentesis Pump should be
Manufactured for:
© 2016 GI Supply. All rights reserved.
RenovaR
®
Paracentesis Pump
Operating Manual