Cantel Medical MEDIVATORS ENDO STRATUS EGA-501 User manual

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MODEL: EGA-501
MODEL: EGA-501E
GI Endoscopy CO
2
Insufator Instruction Manual
MEDIVATORS®, ENDO STRATUS®, ENDO SMARTCAP®, and ENDOGATOR® are registered trademarks of
Medivators Inc.
FUJIFILM™ is a trademark of Fujilm Corporation.
OLYMPUS® is a registered trademark of Olympus Corporation.
PENTAX® is a registered trademark of Hoya Corporation.
ENDOSTAT™ is a trademark of Boston Scientic Corporation.
www.medivators.com
Manufactured in the USA by:
Medivators
3150 Pollok Drive
Conroe, TX 77303
Tel: [phone]
Medivators BV
Sourethweg 11
6422PC Heerlen
The Netherlands
Tel: [phone]
Medivators Inc.
14605 28th Avenue North
Minneapolis, MN 55447 USA
Toll Free: +1.800.444.4729
© 2015 Medivators Inc.
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Table of Contents
I. Unpacking and Inspection..............................................................................3
II. Introduction......................................................................................................3
Denitions........................................................................................................3
Indications for use...........................................................................................3
Contraindications.............................................................................................3
III. Warnings and Cautions....................................................................................4
IV. Product Features..............................................................................................6
SafetyFeatures.................................................................................................6
Theory of Operation.........................................................................................6
V. Technical Specications..................................................................................6
Electrical..........................................................................................................6
Mechanical.......................................................................................................7
CO
2
...................................................................................................................7
Environmental requirements..........................................................................8
Accessories.....................................................................................................8
Replacementparts...........................................................................................8
VI. Front Panel Controls/Connections..................................................................9
VII. Rear Panel Connections.................................................................................10
VIII. Setup and Operation.......................................................................................11
Initial Setup.................................................................................................11
Air hose attachment.....................................................................................11
Pre-procedure setup.....................................................................................11
Water warming..............................................................................................12
Operation.......................................................................................................12
Shutdown......................................................................................................12
IX. Care and Maintenance....................................................................................13
Cleaning.........................................................................................................13
Maintenance..................................................................................................13
X. EMC Tables......................................................................................................14
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Instruction Manual
I. Unpacking and Inspection:
Upon receiving the ENDO STRATUS®CO
2
insufator, ensure that the following items are included in the
shipping box:
• Base tray and water bottle holder
• Hardware for assembling water bottle holder
• Operator’s manual
• Power cord
READ THIS MANUAL THOROUGHLY BEFORE PROCEEDING WITH THE
OPERATION OF THIS EQUIPMENT.
The user manual is written at a level such that it can be understood by the intended users and is
consistent with the education and training of users. These instructions should be stored and used for
reference as needed. If there are any questions, please contact Customer Service - Service Department
at 800-444-4729 / International: 01-782-594164
II. Introduction:
Denitions:
• Throughout this document the ENDO STRATUS CO
2
insufator may be referred to as “unit”
or “device”
• L/min – Liters per minute (ow)
• kPa – kilo Pascal (pressure)
• VAC – Volts Alternating Current (electrical potential)
• W – Watts
• Hz – Hertz (frequency)
• PSI – Pounds Per Square Inch (pressure)
Indications for Use:
The ENDO STRATUS CO
2
insufator is designed to use CO
2
as a distention media in the gastrointestinal tract
when used in conjunction with a gastrointestinal endoscope.
The ENDO STRATUS CO
2
insufator contains a CO
2
warming feature that allows the clinician to modulate and
control delivery of CO
2
to the patient that has been warmed to a target temperature 37°C.
Contraindications:
The ENDO STRATUS CO
2
insufator should only be used by or under the direct guidance of a physician expe-
rienced in the standard practices of gastrointestinal endoscopy procedures. It should only be used for proce-
dures where insufation of the gastrointestinal tract is necessary to support navigation of the GI endoscope and
performance of any necessary evaluation procedures. The device should not be used in any other method or
for any other treatments or procedures.
The device is contraindicated for laparoscopic or hysteroscopic insufation. It must not be used for intrauterine
distension.
The device is contraindicated for CT colonography. Also, the device is not intended for use with or exposure to
magnetic resonance imaging (MRI) systems. Do not use the device in an environment where it could be
exposed to MRI systems.
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III. Warnings and Cautions
SIGNAL WORDS:
WARNING:
Indicates a potentially hazardous situation which if not avoided, could result in death or serious injury.
CAUTION:
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury.
It may also be used to alert against unsafe practices or potential equipment damage.
Safety Symbols:
Attention
Refer To Operating Instructions
Warning: Dangerous Voltage
Equipotentiality
DO NOT Allow Fingers To Contact Moving Parts.
Hot Surface
MR Unsafe
MR
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WARNINGS
A. To reduce risk of electrical shock, do not remove cover. Refer servicing to qualied service personnel.
B. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protec-
tive earth.
C. The ENDO STRATUS® CO
2
insufator is not suitable for use in the presence of a ammable anesthetic
mixture with oxygen.
D. The ENDO STRATUS CO
2
insufator shall be sold only by prescription for use by physicians/clinicians who
are trained and qualied.
E. Only qualied medical personnel in an acceptable medical facility should operate the ENDO STRATUS CO
2
insufator.
F. The ENDO STRATUS CO
2
insufator should be connected to a properly grounded receptacle marked
“Hospital Grade” or “Hospital Only,” otherwise grounding reliability cannot be achieved.
G. Extreme precaution must be taken when handling liquids around electrical equipment. DO NOT operate
the
ENDO STRATUS CO
2
insufator if liquid has been spilled on the unit.
H. Never place or stack the ENDO STRATUS CO
2
insufator on other electrical equipment other than the
ENDO STRATUS irrigation pump. Electromagnetic or other interference may occur between the ENDO
STRATUS CO
2
insufator and other electronic devices. The equipment or system should be observed to
verify normal operation in the conguration in which it will be used.
I. The ENDO STRATUS CO
2
insufator should only be used in conjunction with other equipment whose
safety against leakage currents has been established.
J. The instructions contained in the operating manuals of any equipment to be used in conjunction with the
ENDO STRATUS CO
2
insufator must be followed to avoid any possible hazard from incompatibility.
K. The instructions for use described in this manual MUST be followed. Otherwise, compromised safety,
malfunction, injury to the operator and/or patient, or costly damage to the unit and other equipment may
occur.
L. The ENDO STRATUS CO
2
insufator must be connected to an appropriate power source when loss of
power source would result in an unacceptable risk.
CAUTION
A. If emergency or abnormal function occurs, immediately turn off the power to the unit.
B. Use only medical USP medical grade CO
2
from a “D” or “E” size CO
2
tank.
C. Read and understand all warnings that come with your commercially available “D” or “E” sized CO
2
tanks.
D. Field-servicing of the ENDO STRATUS CO
2
insufator is limited to the replacement of the power cords,
high pressure hoses, yoke adapters, water bottle holder and heater assemblies, and fuses.
E. Remove power from the device before initiating any eld servicing of the replacement parts.
F. There are no user serviceable parts inside this unit. Repairs to the ENDO STRATUS CO
2
insufator should
only be performed by qualied service personnel. No user modication of this equipment is allowed.
G. When the low pressure warning indicator illuminates, exchange the CO
2
tank as soon as possible to avoid
loss of function.
H. Always keep a spare full tank of CO
2
nearby for quick access.
I. Always keep the CO
2
tank in an upright position to avoid uid entering the unit.
J. Do not use the device if the enclosure is damaged or enclosure integrity has been compromised.
K. Do not attempt to operate the device before reading and understanding all sections of this manual.
L. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in section X.
M. Portable and mobile radio frequency (RF) communications equipment can affect medical electrical
equipment. Do not expose the device to sources of electromagnetic interference such as CT equipment,
diathermy equipment, cellular phones, RFID tags and metal detectors.
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IV. Product Features
• Internal CO
2
warmer eliminates cold CO
2
• Includes control for optional water bottle warmer to maintain water at close to body
temperature
• Stackable with the ENDO STRATUS® irrigation pump
• Standard male luer lock output
• Uses standard “D” or “E” size CO
2
cylinders
• Accepts input from wall CO
2
with standard DISS type connection
• Usable at CO
2
input pressures lower than most comparable units, making efcient use of tank
supply
• Works with disposable ENDO SMARTCAP® and ENDOGATOR® hybrid tubing for safety and
compliance
Safety Features
• Dual inline pressure regulators ensure a constant pressure
• Additional mechanical pressure relief at ≤12 PSI prevents overpressure
• Low CO
2
input pressure is indicated by a yellow light on the front panel
• On initial power up, gas ow is off until the ow knob is turned on
• CO
2
warmer will not operate unless ow is initiated
Theory of Operation
The ENDO STRATUS CO
2
insufator works by regulating CO
2
from a tank source to a preset pressure and
then controlling the output of CO
2
to an GI endoscope system for ultimate delivery as a distention media in the
gastrointestinal tract. The clinician will use the air/water valve on the GI endoscope and visual feedback of the
GI endoscopic system to manually distend the gastrointestinal tract with CO
2.
The ENDO STRATUS CO
2
insufator contains a CO
2
warming feature that allows the clinician to modulate and
control delivery of CO
2
to the patient that has been warmed to a target temperature of 37°C with an upper tol-
erance of +3°C. Warming is achieved as CO
2
ows across a heating element which can be switched on or off
by the user, depending on if warming of the CO
2
is desired. The heating of the CO
2
is accomplished through
an internal 20W heating element with dual redundant temperature sensors.
The ow rate can be adjusted to low, medium or high settings depending on the desired rate of insufation,
with ow rates of 1.4 L/min, 2.4 L/min and 3.5 L/min maximum, respectively.
When the unit is turned on, the CO
2
ow and heating function are off by default. To initiate gas ow the user
must turn the ow setting knob from the “off” position. The unit will detect gas ow and will not allow the heater
to operate unless gas ow is detected. In addition, there is a low gas pressure sensor and the unit will indicate
when the input CO
2
pressure reaches 25PSI by illuminating a yellow light on the front panel.
The unit also has an output to power the water bottle warmer. The water bottle heating element maintains the
temperature of the water in a sterile water bottle at 37±3°C. It is controlled by dual temperature sensors for
redundancy and safety.
V. Technical Specications
Electrical Specications
Input Voltage: 100-240 VAC
Input Frequency: 50-60 Hz
Power Consumption: 82 VA
Fuse Rating: M10AL250V
Medium acting, 10 amp, low breaking capacity, 250 volt
Replace fuses only with those of same type and rating
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Certications: IEC-60601-1, IEC-60601-1-2, IEC-60601-2-18
Classication: Class 1 Type B
IP rating (Ingress Protection): IP24
Mechanical Specications
Physical Dimensions:
Height 4 ¾” inches 121 mm
Width 7 ¾” inches 197 mm
Depth 13 ¾” inches 349 mm
Weight 10.5 pounds 4.8 kg
CO
2
Specications
Free Flow rates (maximum unrestricted output to GI endoscope system):
Front panel setting
Low: 1.4 L/min
Medium: 2.4 L/min
High: 3.5 L/min
GI Endoscopic Flow rates (approximate ow rate at GI endoscope output):
Front panel setting
Low: 0.6-0.9 L/min*
Medium: 1.2-1.4 L/min*
High: 1.5-1.8 L/min*
*These values are approximate and are based on testing with respective models of GI endoscopes. User results
may vary depending on GI endoscope used, channel diameter, and channel length.
Output Connection: Male luer lock
Input Connection: ¼” male are tting.
CO2Heater: 20W, internal, ow through, with dual redundant temperature sensors.
CO2Output temperature: 37°C (+3°C)
Operating Pressure:
Input Pressure 1900 PSI Maximum
25 PSI Minimum*
*The low pressure warning light will illuminate at 25 PSI or less, although the unit may still ow. It is
recommended to replenish the CO
2
supply when the light illuminates.
Pressure regulator set point 8 PSI Maximum
Internal safety relief valve ≤12 PSI
Grounding reliability can only be achieved when connected to a receptacle marked “Hospital Grade”.
WARNING:
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Environmental requirements:
Operating Temperature: 16° to 24°C (+61° to 75°F)
Operating Relative Humidity: 30% to 75% non-condensing
Operating Pressure: 70 kPa-106 kPa_(10.2 PSI -15.4 PSI)
Storage Temperature: 0° to 40°C (32° to 104°F)
Storage Relative Humidity: 10% to 95% non-condensing
Storage Pressure: 70 kPa-106 kPa_(10.2 PSI -15.4 PSI)
Altitudes below 3000m
Accessory Items
The ENDO STRATUS®CO
2 insufator is intended to be used only with the specic models
of compatible tubing sets, connectors and accessories identied in the table below and/ or
ofcially recommended by Medivators. Use of the device with accessories not identied in
the table below or ofcially recommended by Medivators may result in incompatibility and/ or
the risk of cross contamination and infection transmission.
Order Number Description
100145CO2, 100145CO2U ENDO SMARTCAP® tubing for OLYMPUS®140/240, 160/260,
180/280 (24 hr Use) series GI Endoscopes
100150CO2, 100150CO2U ENDO SMARTCAP tubing for OLYMPUS 100/200, 130/230 Series
(24 hr Use) GI Endoscopes and PENTAX® GI Endoscopes
100165CO2, 100165CO2U ENDO SMARTCAP tubing for FUJIFILM™ GI Endoscopes
(24 hr Use)
100141 ENDO SMARTCAP™ adaptor for FUJIFILM™ 530 Series
Colonoscopes (Single Use)
100605, 100605S ENDOGATOR® hybrid tubing for OLYMPUS 140/160/180
(24 hr Use) Series GI Endoscopes with OLYMPUS OFP or ENDOSTAT™ II Pump
Irrigation Units
100606, 100606S ENDOGATOR hybrid tubing for OLYMPUS 140/160/180
(24 hr Use) Series GI Endoscopes with OLYMPUS AFU-100, OLYMPUS OFP or
EGP-100 irrigation Units
100551 CO
2 Source Tubing
Replacement parts
Order Number Description
EGA-7014 Power cord (E.U.)
EGP-042 Power cord (U.K.)
EGA-7011 High pressure hose
EGA-7012 Yoke adapter
EGA-7010 Water bottle holder and warmer assembly
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Note: All status indicator lights will be green during normal operation.
NOTE:
VI. Front panel controls/connections
1. On/Off push button
Turns main power on or off to the unit
2. Water warmer On/Off
Push to turn water warmer on or off
3. CO
2
Flow control
Controls ow rate of CO
2
output. The three levels are represented by three green indicators of “L”, “M”,
and “H” which are illuminated to indicate the ow rate setting. The ability to quickly turn off CO
2
ow is
available by pressing the ow control knob in. This will immediately turn the ow of CO
2
off and extinguish
the CO
2
ow light indicator. By turning the CO
2
ow control knob off and then back to your desired ow
rate setting (“L”, “M”, “H”) will restart the ow of CO
2
. The ow rates are as follows*:
Low – 1.4L/min
Medium – 2.4L/min
High – 3.5L/min
*Flow rates shown are maximum free ow measurements at output of unit
Low gas pressure is indicated by the words “LOW PRESSURE” ashing to notify the user that the gas input
pressure has fallen below 25PSI.
4. CO
2
gas output connector
Connect to tubing and GI endoscope.
Standard male luer lock connector.
5. CO
2
gas heater On/Off
Push to toggle CO
2
gas heater On or Off
(The appearance of your device may dier slightly from picture shown above)
1
2
3
4
5
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VII. Rear Panel Connections
1. Water bottle warmer connection
Power connection for water bottle warmer
Refer to section VIII for warmer explanation
2. CO 2 input connection
For connecting a “D” or “E” sized CO
2
tank. Use only pre-ltered medical grade CO
2
gas.
3. Equipotentiality (Earth Ground)
4. AC power connection
AC power input 100-240 VAC, 50-60HZ
5. Fuse receptacle
6. Water bottle holder
The water bottle holder contains the warming system for the water bottle and connects to the main
ENDO STRATUS® CO
2
insufator by means of an electrical cable which plugs into the receptacle marked
“water warmer”.
Replace only with type and rating marked M10AL250V
WARNING:
Use only the hospital grade power line cord supplied with this unit. Connect only to
a power receptacle marked as hospital grade.
WARNING:
6
1245
3
(The appearance of your device may differ slightly from picture shown above)
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VIII. Setup and Operation
Initial Setup
1. Place the ENDO STRATUS® CO
2
insufator on a at surface such as an accessory cart or other suitable
working surface.
2. Before beginning, inspect the ENDO STRATUS CO
2
insufator for any signs of damage.
3. Connect the power cord to the back of the device.
4. Before connecting the power cord to the hospital grade wall receptacle, make sure the power is off, and no
accessories are connected. Then plug the power cord into the wall receptacle.
5. Assemble the water bottle holder and warmer assembly in the following manner:
A. The following supplies are necessary and can be found in a bag attached to the water bottle
holder:
a.) Short Screws (2)
b.) Long Screws (2)
c.) Large Hex Key
d.) Small Hex Key
B. Attach the water bottle holder to the base tray using the (2) small screws and small hex key.
C. Place the ENDO STRATUS CO
2
insufator on the base tray and install the (2) long screws
using the large hex key.
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D. Adjust the water bottle hold-down bracket to t the water bottles used by your facility. This
is done by loosening the nut on the back and sliding the bracket up or down so it contacts the
water bottle and then re-tightening the nut.
6. Plug the water warmer cable into the receptacle marked “water warmer” on the back of the unit.
Air hose attachment
Tools required: (not included)
9/16” open-end wrench
¾” open-end wrench
Accessories required:
“D” or “E” size CO
2
tank lled with medical grade CO
2
(not included)
High pressure hose
Yoke adapter
1. Assemble the high pressure hose and the yoke by tightening the hose with the 3/4” wrench while
holding the yoke with the 9/16” open-end wrench.
2. Unscrew the T-handle on the yoke to allow it to slip over the top post of the CO
2
tank. The correct
orientation is so that the two pins on the yoke line up with the two alignment holes on the tank.
(CO
2
tank is not included with system, purchase separately)
3. After aligning the two pins, tighten the T-handle rmly.
4. Tighten the other end of the high pressure hose and yoke assembly to the back of the
ENDO STRATUS® CO
2
insufator. Hold the brass tting with wrench and use a second wrench to
tighten the hose nut. DO NOT USE TEFLON TAPE OR THREAD SEALANT ON THE FITTINGS.
Pre-Procedure setup
1. Open the valve on the CO
2
tank approximately 1 turn.
2. Turn the power switch to “On”
3. Test the setup by turning the ow control knob position clockwise. Verify that there is CO
2
owing
out the front output of the unit. If there is no CO
2
observed out the front of the unit verify that the
CO
2
tank is full and check the connection outlined in air hose attachment above.
4. Turn off the ow control knob.
5. Connect the tubing to the front output of the device. Use only ENDO SMARTCAP®tubing or
ENDOGATOR®hybrid tube set manufactured by MEDIVATORS.
6. When using ENDO SMARTCAP™ CO
2 source tubing, attach ENDO SMARTCAP source tubing to
ENDO SMARTCAP tubing or ENDOGATOR hybrid tube set. Attach ENDO SMARTCAP tubing or
ENDOGATOR hybrid tube set to the GI endoscope according to the manufacturer’s instructions.
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CAUTION:
Water Pre-Warming
1. The ENDO STRATUS®CO
2
insufator can be used to control the water bottle warmer system. The
warmer system can maintain the temperature of bottles of sterile water at 37°C (±3°C). However, the
system is not intended to raise the temperature of the water; therefore, pre-warming of the water bottle is
required.
2. The water bottle must be pre-warmed with a method such as a uid warmer if warm water is desired.
Water bottle pre-warming should be performed according to the following instructions:
Place sterile water bottle in a uid warming oven set to 37°±3°C. Do not exceed this temperature.
If warm water is not desired, turn the water warmer on the pump off and place a bottle of room
temperature sterile water on the water bottle holder.
The surface of the water bottle warmer may be hot to the touch.
Operation
Shutdown
NOTE:
If the water warmer has been enabled and has exceeded the upper temperature set point limit,
the water warmer’s switch indicator light will turn blue and the warmer will automatically shut
off. If the switch indicator light is ashing blue, ensure the water warmer cable is plugged into
the back of the unit. If it is connected and the light is ashing, this may indicate a problem with
the unit. Contact technical service at 800-444-4729.
1. After the pre-procedure setup has been completed as outlined in section VIII, ow can be initiated.
2. Turn the ow control knob to the rst position. “L” will illuminate for “LOW”. If a higher ow rate is desired,
turn the knob to the next position for “MEDIUM” and one more position for “HIGH”. “M” will illuminate
for “MEDIUM” and “H” will illuminate for “HIGH”. The knob will turn freely in each direction, and will
increase or decrease the ow rate accordingly. The ability to quickly turn off CO
2
ow is available by
pressing the ow control knob in. This will immediately turn the ow of CO
2
off and extinguish the CO
2
ow light indicator. By turning the CO
2
ow control knob off and then back to your desired ow rate setting
(“L”, “M”, “H”) will restart the ow of CO
2
. See section V for ow rates.
3. If warming of the CO
2
is desired, press the button for the CO
2
heater. The button will illuminate green.
4. If the device is attached to a water bottle warmer, and water warming is desired, press the button for water
bottle warmer. The button will illuminate green.
5. Use the appropriate air/water valve on the GI endoscope and visual feedback of the GI endoscopic system
to manually distend the gastrointestinal tract with CO
2
.
1. When the procedure is over, turn the knob counter clockwise until all lights are off, turn off the water bottle
warmer (if attached) and turn off the CO
2
heater.
2. Turn off the main power switch and disconnect the tubing from the front of the unit.
3. Discard the tubing according to the manufacturer’s instructions for proper disposal.
Read and become familiar with all manufacturer’s instructions on warming ovens
and water bottles regarding maximum uid temperatures. Never exceed 40°C
during water pre-warming. Never use a microwave oven to warm a water bottle,
as this could heat the water to a dangerously high temperature or could result in
uneven warming.
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IX. Care and Maintenance
Cleaning
• Before cleaning ensure the power to the unit is turned off and the electrical cord unplugged.
• The outside surface of the unit can be cleaned with a damp cloth, 70% isopropyl alcohol solution, or a 10%
bleach with water solution as often as deemed necessary.
• To disinfect the outside surface, use a mild disinfectant as needed according to the manufacturer’s
instructions.
• Do not use abrasive or harsh cleaners.
• Do not allow liquid to enter the unit.
• Do not sterilize the unit by any means.
Maintenance
Servicing
The device is not user serviceable (excluding the replacement parts listed in section V). Please contact
Customer Service and obtain a Return Material Authorization (RMA) Number. The RMA number must
accompany all units and paperwork for proper service or warranty work.
Limited Warranty
Subject to the terms below, Medivators Inc. (the “Company”) warrants that its products (the “Products”) will
conform to the Company’s written specications (where applicable) and will be free from defects in material and
workmanship under normal use and service for the following periods (the “Warranty Period”):
Endoscope reprocessors and associated equipment, and Irrigation Pumps: fteen (15) months from
date of shipment from the Company or one (1) year from the date of installation, whichever occurs rst.
Consumables, accessories, and Product service parts, including, but not limited to, endoscope hook-
ups, lters, printers, printer supplies, test strips, accessory bags, and service parts for products: ninety
(90) days from the date of installation or one hundred and twenty (120) days from the date of shipment,
whichever occurs rst.
Disposable Products: warranted for single use. The Warranty Period will not in any case exceed the
expiration date on the Product label.
The warranty does not cover, and the Company will have no warranty obligation whatsoever with respect
to, any damage to a Product caused by or associated with: (i) external causes, including without limitation,
accident, vandalism, acts-of-God, power failure or electric power surges, (ii) abuse, misuse or neglect of the
Product by the customer or use of unauthorized third party lters or other consumables and accessories, (iii)
usage not in accordance with product instructions, (iv) the
customer’s failure to perform required preventive maintenance, or (v) servicing or repair not authorized by the
Company.
Limitation of Remedy
The warranty obligation of the Company hereunder is limited to (at its option) (i) the repair or replacement of the
defective Products or any parts it deems defective, or (ii) a refund of the purchase price. This will be customer’s
exclusive remedy for a covered defect.
In order to recover under the warranty, the customer must notify the Company in the state (if in the U.S.A.) or
the country of installation, of the defect (describing the problem in reasonable detail) prior to the expiration of
the Warranty Period and within thirty (30) days of discovery of the defect. Upon receiving the Company’s ofcial
“Returned Material Authorization” (RMA), the customer must promptly return the defective part or Product to
the Company (or the service center indicated on the RMA), freight and insurance prepaid. The Company will not
be responsible for any damage during shipment.
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X. EMC Tables
Table 1 – Guidance And MANUFACTURER’S Declaration
ELECTROMAGNETIC EMISSIONS
For All ME EQUIPMENT And ME SYSTEMS
The EGA-501/EGA-501E is intended for use in the electromagnetic environment specied below. The
customer or user of the EGA-501/EGA-501E should ensure that it is used in such an environment.
Emissions Test Electromagnetic Environment-Guidance
Compliance
RF Emissions
CISPR 11
RF Emissions
CISPR 11
Harmonics
IEC 61000-3-2
Flicker
IEC 61000-3-3
Complies
Class A
Class A
Group 1 The EGA-501/EGA-501E uses RF energy only for its
internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference
in nearby electronic equipment.
The EGA-501/EGA-501E is suitable for use in all
establishments, other than domestic, and those
directly connected to the public low-voltage power
supply network that supplies buildings used for
domestic purposes.
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
Warranty Disclaimer
THE WARRANTY ABOVE IS THE COMPANY’S ENTIRE WARRANTY OBLIGATION TO THE PURCHASER
OF PRODUCTS. IT IS IN LIEU OF ALL OTHER WARRANTIES OF THE COMPANY, EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, AND THE COMPANY DOES NOT REPRESENT OR WARRANT THAT ANY PRODUCT WILL MEET
CUSTOMER’S REQUIREMENTS. THE COMPANY’S RESPONSIBILITY FOR DEFECTS IN A PRODUCT IS LIM-
ITED SOLELY TO REPAIR, REPLACEMENT OR REFUND OF THE PURCHASE PRICE AS SET FORTH IN THIS
WARRANTY STATEMENT. TO THE EXTENT PERMITTED BY LAW, THE COMPANY SHALL NOT, UNDER ANY
CIRCUMSTANCES, BE LIABLE TO CUSTOMER FOR CONSEQUENTIAL, INCIDENTAL, INDIRECT, PUNITIVE
OR SPECIAL DAMAGES OR LOSSES, INCLUDING WITHOUT LIMITATION, DAMAGES ARISING OUT OF OR
IN CONNECTION WITH ANY MALFUNCTIONS, DELAYS, LOSS OF PROFIT, INTERRUPTION OF SERVICE, OR
LOSS OF BUSINESS OR ANTICIPATORY PROFITS, EVEN IF THE COMPANY HAS BEEN APPRISED OF THE
LIKELIHOOD OF SUCH DAMAGES OCCURRING.
This Warranty gives the customer of Products specic legal rights, and customers may also have other rights
which vary from jurisdiction to jurisdiction.
In no event shall the Company’s liability exceed the original purchase price of the covered Product.
No representative or agent of the Company has any authority to bind the Company to any other representation
or warranty with respect to the Products, and the customer accepts the Products subject to all of the terms
above.
Disposal
No special care is needed when disposing of the device.
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Table 2 – Guidance And MANUFACTURER’S Declaration
Electromagnetic IMMUNITY
For All ME EQUIPMENT And ME SYSTEMS
Immunity Test Electromagnetic Environment – GuidanceCompliance
Level
ESD
EN/IEC 61000-
4-2
EFT
EN/IEC 61000-
4-4
Voltage Dips/
Dropout
EN/IEC 61000-
4-11
Surge
EN/IEC 61000-4-5
100% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
Note 1
Mains power quality should be that of a
typical commercial or hospital environment. If the
user of the EGA-501/EGA-501E requires continued
operation during power mains interruptions, it is
recommended that the
EGA-501/EGA-501E be powered from an uninter-
ruptible power supply or battery.
±1kV Differential
±2kV Common
Mains power quality should be that of a
typical commercial or hospital environment.
±2kV Mains
±1kV I/Os
Mains power quality should be that of a
typical commercial or hospital environment.
±6kV Contact
±8kV Air Floors should be wood, concrete or ceramic tile. If
oors are synthetic, the r/h should be at least 30%
Power frequency magnetic elds should
be that of a typical commercial or hospital
environment.
±1kV Differential
±2kV Common
Power Frequency
50/60Hz
Magnetic Field
EN/IEC 61000-
4-8
3A/m 3A/m
±2kV Mains
±1kV I/Os
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
The EGA-501/EGA-501E is intended for use in the electromagnetic environment specied below. The
customer or user of the EGA-501/EGA-501E should ensure that it is used in such an environment.
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
±6kV Contact
±8kV Air
EN/IEC 60601
Test Level
Note 1 The EUT shuts off and must be manually restarted by the operator during a 5 second loss of AC Mains
power.
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Table 4 – Guidance And MANUFACTURER’S Declaration
Electromagnetic IMMUNITY
For ME EQUIPMENT And ME SYSTEMS That Are Not LIFE-SUP-
PORTING
Conducted RF
EN/IEC 61000-4-6
Radiated RF
EN/IEC 61000-4-3
Compliance
Level
(3)Vrms)
(3)V/m)
Electromagnetic Environment – Guidance
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
EN/IEC 60601
Test Level
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
The EGA-501/EGA-501E is intended for use in the electromagnetic environment speci-
ed below. The customer or user of the EGA-501/EGA-501E should ensure that it is
used in such an environment.
Portable and mobile communications equipment
should be separated from the EGA-501/EGA-501E
by no less
than the distances calculated/listed below:
D=(3.5/V1)(Sqrt P)
D=(3.5/E1)(Sqrt P)
80 to 800 MHz
D=(7/E1)(Sqrt P)
800 MHz to 2.5 GHz
Where P is the max power in watts and D is the
recommended separation distance in meters.
Field strengths from xed transmitters, as
determined by an electromagnetic site survey, should
be less than the compliance levels (V1 and E1).
Interference may occur in the vicinity of equipment
containing a transmitter.
Immunity Test
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Max Output
Power
(Watts)
Separation (m)
800MHz to 2.5GHz
D=(7/E1)(Sqrt P)
Separation (m)
80 to 800MHz
D=(3.5/E1)(Sqrt P)
0.01
0.1
10
1
3.6893 7.3786
1.1666 2.3333
.3689 .7378
.1166 .2333
23.333
1.1666
100 11.6666 11.6666
.3689
3.6893
The EGA-501/EGA-501E is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of the EGA-501/EGA-501E can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF Communications Equipment and the EGA-501/EGA-501E as recommended below, according
to the maximum output power of the communications equipment.
Recommended Separations Distances for the EGA-501/EGA-501E
.1166
Separation (m)
150kHz to 80MHz
D=(3.5/V1)(Sqrt P)
Table 6 – Recommended Separation Distances
Between Portable And Mobile
RF Communications Equipment And The EGA-501/EGA-501E
EQUIPMENT and SYSTEMS That Are Not LIFE-SUPPORTING
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MODELL: EGA-501
MODELL: EGA-501E
CO
2
-Insufator für die gastrointestinale Endoskopie - Bedienungsanleitung
MEDIVATORS®, ENDO STRATUS®, ENDO SMARTCAP®, und ENDOGATOR® sind Marken oder eingetragene Marken von Medivators Inc.
FUJIFILM™ ist eine eingetragene Marke der Fujilm Corporation.
OLYMPUS® ist eine eingetragene Marke der Olympus Corporation.
PENTAX® ist eine eingetragene Marke der Hoya Corporation.
ENDOSTAT™ ist eine Marke der Boston Scientic Corporation.
www.medivators.com
Manufactured in the USA by:
Medivators
3150 Pollok Drive
Conroe, TX 77303
Tel: [phone]
Medivators BV
Sourethweg 11
6422PC Heerlen
The Netherlands
Tel: [phone]
Medivators Inc.
14605 28th Avenue North
Minneapolis, MN 55447 USA
Toll Free: +1.800.444.4729
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Inhaltsverzeichnis
I. Auspacken und Prüfung des Inhalts.............................................................................3
II. Einführung......................................................................................................................3
Begriffsbestimmungen....................................................................................3
Anwendungsgebiete .......................................................................................3
Kontraindikationen..........................................................................................3
III. Warnhinweise und Vorsichtsmaßnahmen ....................................................................4
IV. Produktmerkmale ..........................................................................................................6
Sicherheitsfunktionen .....................................................................................6
Funktionsweise ...............................................................................................6
V. Technische Daten.............................................................................................................6
Elektrische Daten............................................................................................6
Mechanische Daten ........................................................................................7
CO2...................................................................................................................7
Umgebungsbedingungen ...............................................................................8
Zubehör ...........................................................................................................8
Ersatzteile........................................................................................................8
VI. Bedienelemente/Anschlüsse Front-Bedienfeld ...........................................................9
VII. Anschlüsse auf der Rückseite.....................................................................................10
VIII. Vorbereitung und Verwendung....................................................................................11
Ersteinrichtung..............................................................................................11
Anbringen des Luftschlauchs.......................................................................11
Vorbereitung vor der Verwendung................................................................11
Aufwärmen des Wassers ..............................................................................12
Betrieb ...........................................................................................................12
Ausschalten des Geräts................................................................................12
IX. Pege und Wartung.....................................................................................................13
Reinigung ......................................................................................................13
Wartung .........................................................................................................13
X. EMV-Tabellen ..................................................................................................................14
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