US endoscopy Co2mpact Endoscopic Insufflator User manual

Rx Only
REF 710300
Operator’s Manual

TABLE OF CONTENTS
SECTION 1.0 UNPACKING AND GENERAL INSPECTION......................................................3
SECTION 2.0 INTRODUCTION.......................................................................................................4
2.1 INDICATION AND CONTRAINDICATIONS ..........................................................................4
2.2 SAFETY FEATURES ..................................................................................................................4
SECTION 3.0 THEORY OF OPERATION......................................................................................5
SECTION 4.0 WARNINGS AND CAUTIONS.................................................................................6
4.1 WARNINGS.................................................................................................................................6
4.2 CAUTIONS ..................................................................................................................................8
4.3 SYMBOLS....................................................................................................................................9
SECTION 5.0 DESCRIPTION OF EQUIPMENT.........................................................................10
5.1 SPECIFICATIONS.....................................................................................................................10
5.2 ELECTRICAL REQUIREMENTS ............................................................................................11
5.3 UL EQUIPMENT CLASSIFICATION......................................................................................11
5.4 ENVIRONMENTAL REQUIREMENTS..................................................................................11
SECTION 6.0 FRONT PANEL CONTROLS.................................................................................12
SECTION 7.0 REAR PANEL CONTROLS ...................................................................................13
SECTION 8.0 ASSEMBLY PRIOR TO USE .................................................................................14
8.1 PREPARATION.........................................................................................................................14
8.2 ELECTRICAL CONNECTIONS...............................................................................................14
8.3 CONNECTING TO A CO2GAS CYLINDER ..........................................................................15
8.4 CONNECTING TO A CO2GAS PIPELINE ADAPTER..........................................................16
SECTION 9.0 SETTING-UP FOR THE PROCEDURE...............................................................17
9.1 POWER ON AND GAS SUPPLY INDICATOR ......................................................................17
9.2 PREPARATION TEST...............................................................................................................18
9.3 TUBING SET CONNECTION ..................................................................................................18
9.4 CONNECTION TO ENDOSCOPIC SYSTEM..........................................................................19
9.5 SYSTEM SET-UP ......................................................................................................................20
9.6 TERMINATING GAS FLOW & SHUT-DOWN PROCEDURES ...........................................21
SECTION 10.0 DECONTAMINATION, CLEANING AND STORAGE......................................22
SECTION 11.0 REPAIR.....................................................................................................................23
11.1 MAINTENANCE CHECKS.......................................................................................................23
11.2 CUSTOMER SERVICES AND ORDERING INFORMATION...............................................26
11.3 WARRANTY .............................................................................................................................26
11.4 CERTIFICATION OF NON-CONTAMINATION ...................................................................26
SECTION 12.0 CERTIFICATE OF NON-CONTAMINATION ...................................................27
SECTION 13.0 TROUBLESHOOTING GUIDE .............................................................................28
SECTION 14.0 EMC TABLES...........................................................................................................35

CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM Operator’s Manual
Page 3
Section 1.0 UNPACKING AND GENERAL INSPECTION
CAUTION: READ ALL SECTIONS OF THIS MANUAL CAREFULLY
BEFORE USING THE CO2MPACT ENDOSCOPIC INSUFFLATOR®
SYSTEM, SUCH THAT OPERATION IS UNDERSTOOD. IF YOU SHOULD
HAVE ANY QUESTIONS, PLEASE CONTACT US ENDOSCOPY
CUSTOMER SERVICES AT 1-800-769-8226 OR YOUR LOCAL US
ENDOSCOPY REPRESENTATIVE.
Proper care and maintenance are critical for safe operation of sophisticated medical
equipment. We recommend careful inspection of all equipment upon receipt and
prior to each use as a safeguard against possible injury to patient or operator.
To avoid inadvertent damage, study this manual thoroughly before handling,
assembling, testing, using, or cleaning the CO2MPACT ENDOSCOPIC
INSUFFLATOR®SYSTEM (also referred to in this manual as "unit", or "device", or
“ENDOSCOPIC INSUFFLATOR”).
Examine the shipping carton and instrument for signs of damage. Any breakage or
other apparent damage should be noted, the evidence retained, and the carrier or
shipping agency notified.
Verify that the shipping carton contains the items listed below:
CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM
Line Cord (see caution below)
Operator’s Manual (English hardcopy)
Quick Reference Guide
Foreign Language Operator Manual and Quick Reference Guide: CD Format
Optimum Performance Warning Label
Air Pump Label
Notify US Endoscopy Customer Services immediately if any damage or
discrepancies are noted.
Phone: [phone]
CAUTION: The line cord (mains lead) supplied with this unit is designed and approved for use in
the USA and Canada only, and should not be used outside these countries. For use
outside of the USA and Canada, your Distributor will supply a line cord that is
approved for use in your country.

CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM Operator’s Manual
Page 4
Section 2.0 INTRODUCTION
This manual provides information for the operation of the CO2MPACT
ENDOSCOPIC INSUFFLATOR®SYSTEM.
DEFINITIONS
The following list is abbreviations of commonly used terms throughout this manual:
LPM
Liter Per Minute (or Liters Per Minute)
mm Hg
millimeters of Mercury
gas
CO2
hPa
Hectapascal
2.1 INDICATION AND CONTRAINDICATIONS
Indications for Use: The CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM
is designed to use CO2 as a distention media in the gastrointestinal tract when used in
conjunction with a gastrointestinal endoscope.
Contraindications for Use:
The CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM should be used only
for an endoscopic procedure when insufflation of the gastrointestinal tract is
necessary to support navigation of the endoscope and perform any evaluation
procedures through the endoscope, and should therefore not be used for any other
treatments. It should only be used under the direct guidance of a physician
experienced in Gastrointestinal Endoscopy procedures.
This device is contraindicated for hysteroscopic or laparoscopic insufflation, i.e., it
must not be used for intrauterine distension.
This device is contraindicated for CT Colonography.
2.2 SAFETY FEATURES
The following features help to ensure safe operation of the machine:
START/STOP button: Upon turning power on, gas flow is not initiated until the
START/STOP button is pressed.
If the outlet pressure exceeds 375 mmHg, a fixed mechanical pressure relief valve
will open.
An audible indicator will sound when the CO2gas supply tank pressure is low.
Additionally, the Gas Supply Indicator LED light will turn red.
A user-adjustable automatic gas shutoff timer is present, which prevents the device
from running continuously. The shutoff timer can be set to 30, 60, or 120 minutes.

CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM Operator’s Manual
Page 5
Section 3.0 THEORY OF OPERATION
The CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM operates by
administering CO2at a selectable flow rate of 2.0 LPM (Low), 2.9 LPM (Medium),
or 3.4 LPM (High), nominally. The flow rate is selected by the operator, by using a
button found on the front panel to select from Low, Medium, and High. The
clinician will use the air/water valve on the endoscope and visual feedback of the
endoscopic system to manually distend the gastrointestinal tract with CO2. The unit
operates in an identical manner to that of the air pump of an endoscopic system.
The user will need to place the system into START mode in order for it to deliver the
CO2to the endoscopic system. This is done by powering ON the unit, and then
depressing the START/STOP button on the front panel of the unit. A green LED
light, adjacent to the START/STOP button, will illuminate indicating that the unit is
ON and delivering CO2.
The CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM has a mechanical
Pressure Relief Valve pre-set to 375 mm Hg. This pressure relief valve is active
whether the START/STOP button is on or off.

CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM Operator’s Manual
Page 6
Section 4.0 WARNINGS AND CAUTIONS
This section describes warning and caution information for safe operation of the
CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM. All information in this
manual, and particularly in this section, should be read thoroughly and understood
before using the device.
4.1 WARNINGS
•Excessive absorption of CO2results from over insufflation. The GI Tract can be
adequately distended by the physician’s modulation of the air/water valve.
•Should accidental intravasion of CO2occur, in rare circumstances, it can result in
embolization.
•Infusion of CO2can result in carbonic acid irritation to directly contacted tissues.
•Idiosyncratic reactions: In patients with sickle cell disease or pulmonary
insufficiency, use of these devices may pose increased risks of metabolic imbalance
related to excessive CO2absorption.
•Use only USP “Medical Grade” CO2.
•Tank designations vary by country. Please check with your local distributor for
compatibility.
•Tubing set is to be changed following standards and guidelines set forth by SGNA
and APIC for reprocessing of water bottles used during Gastrointestinal Endoscopy.
•Using unauthorized, non-US Endoscopy tubing sets will void the warranty and US
Endoscopy cannot assume any risk related to the use of non-US Endoscopy products.
•Equipment is not suitable for use in the presence of a flammable anesthetic mixture
with air, oxygen, or nitrous oxide.
•Never attempt to service the device when it is connected to a power source.
Hazardous voltages inside the device can cause severe electrical shock. Disconnect
the power cord before servicing.
•Ensure that all high-pressure gas line connections are secure before opening the gas
source(s). Loose connections could separate unexpectedly with great force, causing
personal injury.
•This device should be operated only by or under the direct supervision of a licensed
physician experienced in Gastrointestinal Endoscopy. The user should be thoroughly
familiar with the operation of this device prior to use. Additionally, individuals using
this device must be alert and attentive to the operation of the system while it is
connected to the endoscopic system. Diligence on the part of the operator is an
essential requirement of overall device safety.
•To avoid the risk of electrical shock, the unit must be grounded. Always connect the
power cord to a properly wired grounded hospital grade AC outlet (wall mains
outlet).
•To prevent unit contamination, use only US Endoscopy Endoscopic Tubing Sets
which include a ≤0.1micron hydrophobic filter.
•Always instruct the patient to immediately notify the operator of any pain
experienced during the procedure.

CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM Operator’s Manual
Page 7
•If an emergency should arise whereby the need to terminate the procedure is
required, operators should stop the gas flow by turning off the power to the
insufflator and promptly disconnecting the US Endoscopy Endoscopic Tubing Set at
the unit’s Output Port.
•The CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM can release CO2to the
surrounding atmosphere in the event of misuse or a fault condition. Use and store the
CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM in a well-ventilated
environment. Additionally, make sure all CO2connections are correctly installed and
free of visible damage. Should an unexplained rapid discharge of CO2occur,
evacuate the immediate area until it has had sufficient time to ventilate.
•High Pressure USP CO2is supplied to the CO2MPACT ENDOSCOPIC
INSUFFLATOR®SYSTEM from commercially available CO2 supply tanks or from
a wall source. Please read and carefully follow all Warnings, Cautions and Handling
Instructions provided with, and listed on the CO2supply tank or wall source that is
used with the CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM. Failure to
do so can result in Serious Injury or Death.
•This product contains phthalates which have been perceived as having possible
carcinogenic, mutagenic and reproductive risks. However, based on all existing
scientific data, the long history of safe use of medical device products containing
phthalates, as well as the short duration of contact with this device, there are no
known cancer or reproductive risks to humans. Physician discretion is required to
ensure that benefits outweigh risks when this device is used in children, elderly and
pregnant women.
•Caution: Federal (and Canadian) law restricts this device to sale by or on the order of
a licensed medical practitioner.

CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM Operator’s Manual
Page 8
4.2 CAUTIONS
•Do not allow fluids to enter the device.
•The unit should not be opened except by a qualified service person. Tampering by
unqualified persons can damage the unit and void the warranty.
•Verify proper connection of tubing before using the unit.
•This device has not been tested for MR (Magnetic Resonance) compatibility, and
should not be introduced into the MR scanner room.
•To insure electrical grounding reliability, only use a hospital grade UL 498 compliant
power cord.
•Electromagnetic interference or other interference may occur in this instrument when
it is placed near other devices or RF communications equipment such as cellular
phones. If interference occurs, mitigation measures may be necessary, such as
reorienting or relocating the CO2MPACT ENDOSCOPIC INSUFFLATOR®
SYSTEM or shielding the location.
•Do Not attempt to use this system until you have completed all the steps in
“Assembly Prior to Use” Section 8.0 and “Setting-Up for the Procedure” Section 9.0.
If the equipment differs significantly in appearance or operation from the way it is
presented in this manual, or you have any doubts what-so-ever concerning its
installation or operation, inform US Endoscopy Customer Services at
1-800-769-8226.

CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM Operator’s Manual
Page 9
4.3 SYMBOLS
SYMBOL
DEFINITION
SYMBOL
DEFINITION
Type B
Type and
Rating of
Fusing
Consult instructions
for use
CO2Gas Input
Dangerous
voltage
CO2 Gas Output
to the patient
Interconnection to
ensure all equipment
is at the same
potential or earth
ground.
This product should
be recycled and not
disposed of as
general waste
(subject to WEEE
annex IV resp. EN
50419).
In accordance with
European Union
WEEE Directive
2002/96/EC, US
Endoscopy will be
fully responsible for
the coordination,
logistics, and costs
of the WEEE
process

CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM Operator’s Manual
Page 10
Section 5.0 DESCRIPTION OF EQUIPMENT
The CO2MPACT ENDOSCOPIC INSUFFLATOR®SYSTEM is indicated for use as
a means to use CO2 as a distention media in the gastrointestinal tract when used in
conjunction with a gastrointestinal endoscope under direct observation of a physician.
5.1 SPECIFICATIONS
Size: 5.75” wide x 6.5” high x 13.25” deep (± ¼”)
146 mm x 165 mm x 337 mm
Weight: Less than 14 lb. (6.4 kg)
Control Panel: Power switch- Rocker style ON/OFF
START/STOP button- Membrane push-button type
that starts and stops flow of CO2from the unit, with an
associated LED for each setting adjacent to the button.
FLOW button- Membrane push-button type with Low,
Medium, and High settings, with an associated LED for
each setting adjacent to the button.
TIMER button- Membrane push-button type that
selects the amount of time until the flow of gas
automatically stops. Can be set to 30 Minutes, 60
Minutes, and 120 Minutes, with an associated LED for
each setting adjacent to the button. (All time functions
have a tolerance of +/- 10%.)
Gas Supply Indicator- Tri-color LED that indicates
how much gas is remaining in the USP medical grade
gas cylinder.
Gas Flow: (3) user-selectable settings: 2.0 (1.8-2.3) liters/minute
(Low), 2.9 (2.7-3.1) liters/minute (Medium), 3.4 (3.2-
3.6) liters/minute (High)
Operating Pressure: 0 to 375 mm Hg operating range (+0% - 10%).
Pressure Relief Valve: Fixed mechanical pressure relief valve at
375 mm Hg (+0% - 10%). The relief valve is active
whether gas flow is on or off for added protection.
Gas Inlet: USP medical grade CO2supply tank or wall source
supply.
WARNING: Do not allow liquid CO2to enter the unit. This can be prevented by assuring that
the CO2supply tank is maintained in a vertical position at all times.
Gas Input Cylinder Pressure: 43 to 2200 psi
Gas Input Central Supply Pressure: 50 to 203 psi
Tubing Set: Available for use with ≤0.1 micron
hydrophobic filter. US Endoscopy
supplies tubing sets that include this
filter.