US endoscopy CO2EFFICIENT User manual

Rx Only (USA)
Endoscopic Insufflator
REF 710302
Operator’s Manual
US Patent # 7,806,850 and
US Patent # 8,157,763

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual
Page 2
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 ..................................................................................................................................7
SECTION 5.0 DESCRIPTION OF EQUIPMENT...........................................................................8
5.1 SPECIFICATIONS.......................................................................................................................8
5.2 ELECTRICAL REQUIREMENTS ..............................................................................................8
5.3 UL EQUIPMENT CLASSIFICATION........................................................................................9
5.4 ENVIRONMENTAL REQUIREMENTS ....................................................................................9
SECTION 6.0 FRONT PANEL CONTROLS.................................................................................10
SECTION 7.0 REAR PANEL CONTROLS ...................................................................................12
SECTION 8.0 HIGH PRESSURE HOSE AND YOKE ASSEMBLY ..........................................13
SECTION 9.0 ASSEMBLY PRIOR TO USE.................................................................................14
9.1 PREPARATION.........................................................................................................................14
9.2 ELECTRICAL CONNECTIONS...............................................................................................14
9.3 CO2HOSE CONNECTIONS .....................................................................................................15
SECTION 10.0 SETTING-UP FOR THE PROCEDURE...............................................................17
10.1 POWER ON AND GAS SUPPLY INDICATOR.......................................................................17
10.2 PREPARATION TEST ..............................................................................................................17
10.3 TUBING SET CONNECTION ..................................................................................................18
10.4 SETTING MODE OF OPERATION..........................................................................................18
10.5 RESET CO2VOLUME ..............................................................................................................18
10.6 CONNECTION TO ENDOSCOPIC SYSTEM..........................................................................18
10.7 SYSTEM SET-UP......................................................................................................................19
10.8 CO2VOLUME DISPLAY..........................................................................................................20
10.9 TERMINATING GAS FLOW & SHUT-DOWN PROCEDURES............................................20
SECTION 11.0 DECONTAMINATION, CLEANING AND STORAGE......................................21
11.1 MAINTENANCE CHECKS.......................................................................................................22
11.2 CUSTOMER SERVICES AND ORDERING INFORMATION...............................................24
11.3 WARRANTY .............................................................................................................................24
11.4 CERTIFICATION OF NON-CONTAMINATION....................................................................24
SECTION 12.0 CERTIFICATE OF NON-CONTAMINATION ...................................................25
SECTION 13.0 TROUBLESHOOTING GUIDE.............................................................................26
SECTION 14.0 EMC TABLES.........................................................................................................333

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual
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Section 1.0 UNPACKING AND GENERAL INSPECTION
CAUTION: READ ALL SECTIONS OF THIS MANUAL CAREFULLY BEFORE USING
THE CO2EFFICIENT®ENDOSCOPIC INSUFFLATOR, SUCH THAT
OPERATION IS UNDERSTOOD. IF YOU SHOULD HAVE ANY
QUESTIONS, PLEASE CONTACT US ENDOSCOPY CUSTOMER SERVICE
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 CO2EFFICIENT 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:
CO2EFFICIENT ENDOSCOPIC INSUFFLATOR
Operator’s Manual (English Only)
Quick Reference Guide
Foreign Language Operator Manual and Quick Reference Guide: CD Format
Line Cord (mains lead) (see CAUTION below)
High Pressure Hose &Yoke
Optimum Performance Warning Label
Notify 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.

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual
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Section 2.0 INTRODUCTION
This manual provides information for the operation of the CO2EFFICIENT
ENDOSCOPIC INSUFFLATOR, (also referred to in this manual as "unit" or
"device").
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
Hundred Pascal
2.1 INDICATION AND CONTRAINDICATIONS
Indications for Use: The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR 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 CO2EFFICIENT ENDOSCOPIC INSUFFLATOR 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:
FLOW STOP/RUN button: Upon turning power on, gas flow is not initiated until the
FLOW STOP/RUN button is pressed.
An initial pressure relief will occur at 375 mm Hg and a redundant pressure relief
will occur at 400 mm Hg.
An audible alert will sound when the CO2gas supply tank pressure is low.
An audible alert (a single chirp) will sound when the flow of CO2is automatically
stopped by the device.

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual
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Section 3.0 THEORY OF OPERATION
The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR operates by administering
CO2at a maximum flow rate of 3 LPM, and then monitoring the endoscopic
pressure. A mode of operation is selected by the operator, by using a switch found on
the front panel to select from Free Flow Mode and Managed Flow Mode. It is used
to change the rate that the flow is delivered to the endoscopic system. When the
switch is set to Free Flow Mode, the unit will deliver CO2at a flow rate of 3 liters
per minute continuous. 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.
When the switch is set to Managed Flow Mode, the system will be delivering CO2in
a more efficient manner. This mode reduces the amount of CO2that is lost through
the air/water valve which is normally lost at a rate of 3 liters per minute. When gas
is not used in the endoscopic system to insufflate, the unit will operate at the
Managed Flow rate of 0.25 to 1.0 liter per minute. This transition to the Managed
Flow rate will occur if the unit senses no need for insufflation in a 2 second time
period. When gas is needed to insufflate, the unit will deliver CO2at a flow rate of 3
liters per minute.
The user will need to place the system into RUN mode in order for it to deliver the
CO2to the endoscopic system.
The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR has a Pressure Relief Valve
set at 375 mm Hg and an independent redundant Pressure Relief Valve pre-set to 400
mm Hg. Both pressure relief safety devices are active whether the
FLOW STOP/RUN is on or off.

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual
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Section 4.0 WARNINGS AND CAUTIONS
This section describes warning and caution information for safe operation of the
CO2EFFICIENT ENDOSCOPIC INSUFFLATOR. 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 respiratory acidosis
related to excessive CO2absorption.
•Use only USP “Medical Grade” CO2available in “D”or “E”supply tanks.
•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 brand tubing sets will void the warranty. US
Endoscopy cannot assume any risk related to the use of non-US Endoscopy brand
product.
•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, connect the power cord to a properly wired
grounding receptacle only.
•To prevent unit contamination, use only CO2Endoscopic Tubing Set which includes
a ≤0.1micron hydrophobic filter.
•Always instruct the patient to immediately notify the operator of any pain
experienced during the procedure.

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual
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•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 CO2Endoscopic Tubing Set at the unit’s
Output Port.
•The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR can release CO2to the
surrounding atmosphere in the event of misuse or a fault condition. Use and store the
CO2EFFICIENT ENDOSCOPIC INSUFFLATOR in a well-ventilated environment.
Additionally, make sure all CO2supply tank connections 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 CO2EFFICIENT ENDOSCOPIC
INSUFFLATOR from commercially available CO2 supply tanks. Please read and
carefully follow all Warnings, Cautions and Handling Instructions provided with,
and listed on these CO2supply tanks that are used with the CO2EFFICIENT
ENDOSCOPIC INSUFFLATOR. 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.
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.
•Do Not attempt to use this system until you have completed all the steps in
“Assembly Prior to Use” Section 9.0 and “Setting-Up for the Procedure” Section
10.0. 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 customer service at 1-800-769-8226.

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual
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Section 5.0 DESCRIPTION OF EQUIPMENT
The CO2EFFICIENT ENDOSCOPIC INSUFFLATOR 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: 10” wide x 5.5” high x 10.5” deep. (± ¼”)
254 mm x 140 mm x 267 mm
Weight: Less than 20 lb. (9.0 kg).
Control Panel: Push-buttons and rocker switch. Digital pressure and
volume readouts.
Gas Flow: 0 to 3 LPM. (± 20%) Not to exceed 3.6 LPM.
Operating Pressure: 0 to 350 mm Hg operating. (±10%)
Pressure Relief Valve: Relief of pressure at 375 mm Hg (+0%/-10%)
A redundant relief of pressure at 400 mm Hg. (+0%/-
24mmHg)
Both reliefs are active whether gas flow is on or off for
added protection.
Operating modes: Managed Flow, Free Flow, and FLOW STOP/RUN.
Gas Inlet: “D”or “E”CO2supply tank.
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 Pressure: 75 to 2200 psi, flow to 25 psi.
Tubing Set: Available for use with ≤0.1 micron hydrophobic filter.
US Endoscopy supplies a Tubing Set that includes this
filter.
5.2 ELECTRICAL REQUIREMENTS
Input Voltage: 100 to 240 VAC nominal line voltage; 50/60 Hz.
(line voltage can vary by ±10% from nominal).
Power: 25 watts, double fusing with removable power cord.
Standards: UL-2601-1; IEC-60601-1; IEC-60601-1-2; EN55011;
EN60601-1-2; EN50082-1; EN61000-4-2-3-4-5-6-8-11,
EN61000-3-2-3.

CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual
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5.3 UL EQUIPMENT CLASSIFICATION
Underwriter’s Laboratories/CSA Class I Type B
5.4 ENVIRONMENTAL REQUIREMENTS
Operating Temperature: 50° to 104° F (10° to 40° C)
Operating Relative Humidity: 30 to 70% non-condensing
Operating Pressure: 700 to 1060 hPascal
20.7 to 31.3 (inches of Mercury)
Storage Temperature: 32° to 160° F (0° to 70° C)
Storage Relative Humidity: 20 to 90% non-condensing
Storage Pressure: 500 to 1060 hPascal
14.8 to 31.3 (inches of Mercury)
Not to be used in the presence of flammable gases.
NOTE: This unit has not been tested for MR compatibility and should not be
introduced into the MR exam room.