GI Supply RenovaRP Operating Manual - User Manual

Full Text Searchable PDF User Manual

Renova

Paracentesis Pump

Operating Manual

●

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 tubing assembly.

●

Remove the used tubing and drainage bags. Dispose of
according to facility protocol for biohazard waste.

CLEANING

CAUTION

USE OF AN UNAPPROVED CLEANING SOLU-

TION OR METHOD MAY RESULT IN DAMAGE TO THE PUMP.
USE ONLY APPROVED PRODUCTS AND FOLLOW THE GUIDE-
LINES BELOW.

The GI Supply 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 equiv-
alent material.  Do not use excessive amounts of fluid or spray
fluid directly on 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 a hex or flat head screw driver.
Additional disinfection of the pump should be performed
per institutional guidelines.  Following disinfection, replace
the base and securely tightened all 4 screws to the under-
side of the base.

MAINTENANCE

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
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 on the back
of the pump housing.  If found defective replace with a fuse
of  the  same  type  and  rating  (5x20mm,  F2.5A250V).  This
information is printed on the back of the unit.

STORAGE AND TRANSPORTATION

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.

Operation of the GI Supply Paracentesis Pump for removal
of ascetic 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 is 7-10 years. Disposal
of the GI Supply RenovaRP

Paracentesis Pump should be

done in accordance with institution guidelines for equipment.

SPECIFICATIONS

Physical Specifications
Dimensions:

13 x 9 x 13 in (33 x 23 x 33cm)

Weight:

8.5 lbs (3.9kg)

Functional Specifications

Power Specifications

Input current: 2.5A
Input Voltage: 100- 230V~
Input Frequency: 50/60Hz
Power Cord: Hospital Grade power cord

Environmental Specifications
Operation Conditions:

Temperature: 15°C to 30°C
Relative Humidity: 30-75%
Atmospheric Pressure: 50-106kPa

Storage Conditions:

Temperature: 15°C to 30°C
Relative Humidity: 30-75%
Atmospheric Pressure: 50-106kPa

IEC 60601-1 General Requirements for Safety

This device is BV approved WITH RESPECT TO ELECTRICAL
SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN AC-
CORDANCE 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 Direc-
tive 93/42/EEC and 2007/47/EC (general safety information)

This product complies to the above standards only when
used with the supplied accessories.

WARRANTY

GI Supply warrants this product to be free from defects in
material  and  workmanship  for  a  period  of  ninety  (90)
days from the date of shipment.  If repair or adjustment is
necessary within the warranty period which has not been the
result  of  mishandling  or  abuse,  you  may  return  the  unit
freight prepaid, provided that return authorization has been
obtained.  GI Supply will correct the defect or adjust the unit
at no charge.

Manufactured for:

200 Grandview Avenue • Camp Hill, PA 17011 USA
1-800-451-5797 • 717-761-0216 fax
www.gi-supply.com

GIS0670001 Rev.03

Emissions test

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 suitable for use in all establish-
ments other than domestic, and may be used
in domestic establishments and those di-
rectly connected to the public low-voltage
power supply network that supplies building
used for domestic purposes, provided the fol-
lowing warning is heeded:

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
equipment. It may be necessary to take mit-
igation measures, such as re-orienting or re-
locating the product or shielding the
location.

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.

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.    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 is used 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

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.

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

Amperes

Hertz

Serial Number

Volts

INDICATIONS FOR USE

The GI Supply RenovaRP

Paracentesis Pump is intended as

a suction pump to remove ascetic fluid from the abdominal
cavity in conjunction with the GI Supply 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 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.

WARNINGS

●

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 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 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 GI Supply Paracentesis kit is the
Applied Part.

DESCRIPTION

The GI 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 GI 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 GI 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 GI SUPPLY PARACENTESIS KIT

WITH THE PUMP. USE OF OTHER PARACENTESIS KITS MAY
RESULT IN INADEQUATE PUMP OPERATION AND FLUID
REMOVAL.

LOAD TUBING

●

Position control knob to Standby Mode.

CAUTION:

BE SURE PUMP DRIVE IS IN STANDBY

MODE ( ) BEFORE LOADING TUBING. SERIOUS INJURY
MAY RESULT IF FINGERS ARE INSERTED INTO THE PUMP
ROTOR DURING OPERATION.

●

Lift the flip top track until fully open.

●

Remove the pump tubing from the GI Supply Paracen-
tesis Kit tray and fit section of larger OD tubing across
the pumphead rotor.

CAUTION:

ENSURE THAT THE SECTION OF TUBING

LEADING FROM THE PATIENT ENTERS THE LEFT SIDE OF
THE PUMPHEAD AND EXITS ON THE RIGHT SIDE TO THE
DRAINAGE BAGS. (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)

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 GI 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.

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.

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 valve

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

√

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 and electromagnetic site
survey,

“should be less than

the compliance level in each
frequency range.

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

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.

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

0.23

0.1

0.38

0.73

1.2

2.3

3.8

7.3

100

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

√

800 MHz to 2.5 GHz
d=2.3

√

150 kHz to 80 MHz
d=1.2

√

REF

Luer-Lock
Cap

Pinch
Clamp

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