Medivators ENDO STRATUS EGA-500 User manual

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GI Endoscopy Irrigation Pump Instruction Manual
MODEL: EGA-500E
MODEL: EGA-500
Issue Date: 01/21/2015
ENDOGATOR®, DEFENDO®, Y-OPSY®, MEDIVATORS®, and ENDO STRATUS® are registered trademarks of
Medivators Inc.
FUJIFILM™ is a trademark of FUJIFILM Corporation.
OLYMPUS® is a registered trademark of Olympus Corporation.
PENTAX® is a registered trademark of Hoya Corporation.
EC REP
www.medivators.com
Medivators BV
Sourethweg 11
6442 PC Heerlen
The Netherlands
Phone: [phone]
Manufactured in the USA by:
Medivators
3150 Pollok Drive
Conroe, TX 77303
USA
Tel: [phone]
Medivators Inc. Headquarters
14605 28th Avenue North
Minneapolis, MN 55447 USA
Toll Free: +1.800.444.4729
0050
Irrigation Pump

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Table Of Contents
I. Unpacking And Inspection.....................................................................................................3
II. Introduction.............................................................................................................................3
Denitions..............................................................................................................3
Indications For Use................................................................................................3
Contra-indications.................................................................................................3
III. Warnings And Cautions...........................................................................................................4
IV. Product Features......................................................................................................................6
Theory Of Operation.............................................................................................6
V. Technical Specications............................................................................................................6
Electrical................................................................................................................6
Mechanical.............................................................................................................7
Flow rates...............................................................................................................7
Environmental Requirements..............................................................................7
Accessories.............................................................................................................8
Replacement Parts................................................................................................8
VI. Front Panel Controls/Connections........................................................................................9
VII. Rear Panel Connections.......................................................................................................10
VIII. Setup And Operation...........................................................................................................11
Initial Setup.........................................................................................................11
Pre-procedure Setup...........................................................................................12
Water Pre-Warming.............................................................................................13
Operation.............................................................................................................13
Shutdown.............................................................................................................13
IX. Care And Maintenance............................................................................................................14
Cleaning...............................................................................................................14
Maintenance........................................................................................................14
X. Electromagnetic Compatibility Information.........................................................................15

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Instruction Manual
I. Unpacking And Inspection:
Upon receiving the ENDO STRATUS® irrigation pump, ensure that the following items are contained in the
shipping box:
• Base tray and water bottle holder
• Hardware to assemble base tray and water bottle holder
• Operator’s manual
• Power cord
• Foot pedal
• Pump Head
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 irrigation pump may be referred to as “unit” or
“device”
• mL/min – milliliters per minute (flow)
• VAC – Volts Alternating Current (electrical potential)
• kPa – kilo Pascal (pressure)
• W – Watts
• VA – Volt Amps
• Hz – Hertz (frequency)
Indications For Use:
Federal (USA) law restricts this device to sale by or on the order of physician.
The ENDO STRATUS irrigation pump is indicated for GI endoscopic irrigation with room temperature or warm water for use
with washing catheters, integral GI endoscope water jet channels and GI endoscope working channels.
The device contains a heated water bottle cradle that is intended to maintain a sterile water bottle for GI
endoscopic irrigation at a maximum temperature set point of 37°C with a tolerance of ± 3°C.
Contra-indications:
The device should only be used for GI endoscopic procedures requiring irrigation of the gastrointestinal tract and should not
be used for any other treatments or procedures.
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 qualified service personnel.
B. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth
ground.
C. The ENDO STRATUS® irrigation pump is not suitable for use in the presence of a flammable anesthetic mixture with
oxygen.
D. The ENDO STRATUS irrigation pump shall be sold only by prescription for use by physicians/clinicians who are
trained regarding the amount of water to use for irrigation and infusion.
E. Always watch for abnormal flow rates and adjust the flow rate as necessary. If an unusual flow rate remains after
adjustments have been made, then stop the procedure and investigate.
F. Only qualified medical personnel in an acceptable medical facility should operate the ENDO STRATUS irrigation
pump.
G. The ENDO STRATUS irrigation pump should be connected to a properly grounded 120V receptacle marked
“Hospital Grade” or “Hospital Only,” otherwise grounding reliability cannot be achieved.
H. Extreme precaution must be taken when handling liquids around electrical equipment. DO NOT operate the
ENDO STRATUS irrigation pump if liquid has been spilled on the unit.
I. The ENDO STRATUS irrigation pump should not be used adjacent to or stacked with other equipment other
than another ENDO STRATUS device. Electromagnetic or other interference may occur between the
ENDO STRATUS irrigation pump and other electronic devices. If stacked or adjacent use is necessary, the
equipment or system should be observed to verify normal operation in the configuration in which it will be used.
J. The ENDO STRATUS irrigation pump should only be used in conjunction with other equipment whose safety
against leakage currents has been established.
K. The instructions contained in the operating manuals of any equipment to be used in conjunction with the
ENDO STRATUS irrigation pump must be followed to avoid any possible hazard from incompatibility.
L. 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.
M. The ENDO STRATUS irrigation pump 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. Field-servicing of the ENDO STRATUS irrigation pump is limited to the replacement of the power cords,
water bottle holder and heater assemblies, pump heads, foot pedals and fuses.
C. Remove power from the device before initiating any field servicing of the replacement parts.
D. There are no user serviceable parts inside the ENDO STRATUS irrigation pump unit. Repairs to the
ENDO STRATUS irrigation pump should only be performed by qualified service personnel.
E. Do not use the device if the enclosure is damaged or enclosure integrity has been compromised.
F. Do not attempt to operate the device before reading and understanding all sections of this manual.
G. 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.
H. 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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Grounding reliability can only be achieved when connected to a receptacle marked“Hospital Grade”.
WARNING:
IV. Product Features
• Built in water bottle warmer maintains water at up to 37°C with an allowable tolerance of ± 3°C
• “Prime” feature runs pump for 20 seconds with automatic timer
• Includes side water bottle clip for traditional water bottle holder
• Safety feature prevents pump from running when pump head is open
• Robust motor design for consistent performance
• Water bottle holder is angled for easier access to water bottle and tubing
Theory Of Operation
The ENDO STRATUS® irrigation pump works by turning a peristaltic-roller-type pump head to move
liquid through a tube set and into a GI endoscope system. The pump head will not operate if the pump
head is open, and will cease to operate if the pump head is opened while the motor is activated.
The unit incorporates a “prime” feature which allows the unit to operate for a pre-set period of time. This
feature can be canceled while in progress by pressing the foot pedal.
The water bottle warmer is intended to maintain the warmth of the water in a sterile water bottle that has
been pre-warmed. It is controlled by dual temperature sensors for redundancy and safety. There is a heating
element integrated into the water bottle holder which then radiates heat through the bottle and into the
water. The temperature of the water bottle holder is maintained at a maximum of 37°C ± 3°C.
V. Technical Specications
Electrical Specications
Input Voltage: 100-240 VAC
Input Frequency: 50-60 Hz
Power Consumption: 110 VA
Fuse Rating: M10AL250V
Medium acting, 10 amp, low breaking capacity, 250 volt
Replace fuses only with those of same type and rating
Certications: IEC-60601-1, IEC-60601-1-2, IEC-60601-2-18
Classication: Class 1 Type B
Water Bottle Warmer: 20W resistive element with dual temperature sensors.
IP Rating (Ingress Protection): IP24

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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
Flow Rates:
Auxiliary Water Channel 0-300 ml/min*
Biopsy Channel 0-650 ml/min*
*These values are approximate and are based on an average ow obtained with three dierent
manufacturer’s GI endoscopes with biopsy channel diameters ranging from 2.8 mm - 4.2 mm and
auxiliary water channel diameters ranging from 0.8mm - 1.0 mm. User results may vary depending on
scope used, channel size and working channel length.
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
The ENDO STRATUS® irrigation pump is intended for use only by physicians/clinicians
who are trained regarding the amount of water to use for irrigation and infusion during
GI endoscopic procedures.
CAUTION:

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Accessory Items
Category/Type Description Order Number
ENDOGATOR® Irrigation
Tubing For Use With EGA-500 100130 (24 Hr Use)
ENDOGATOR Irrigation
Tubing For Use With EGA-500E 100130U (24 Hr Use)
Irrigation Tubing
ENDOGATOR Hybrid Tubing For
OLYMPUS® 140/160/180 Series
GI Endoscopes For Use With EGA-500 100609 (24 Hr Use)
ENDOGATOR Hybrid Tubing For
OLYMPUS 140/160/180 Series
GI Endoscopes For Use With EGA-500E 100609S (24 Hr Use)
ENDOGATOR™ Single Patient Use
Auxiliary Water Jet Connector For
OLYMPUS GI Endoscopes 100241 (Single Patient Use)
ENDOGATOR Single Patient Use
Auxiliary Water Jet Connector For
PENTAX® GI Endoscopes 100242 (Single Patient Use)
Adapter For Connecting
Connectors/Valves/ ENDOGATOR Tubing To FUJIFILM™
Adapters 530 Series GI Endoscopes 100141 (Single Patient Use)
Backow Valve 100126 (Single Patient Use)
Biopsy Irrigation Channel Tubing 100135 (Single Patient Use)
ENDOGATOR Channel Adapter 100136 (Single Patient Use)
DEFENDO® YOPSY® Irrigator For
OLYMPUS GI Endoscopes 100303 (Single Patient Use)
Replacement Parts
EGA-500
Item Order Number
Power cord EGA-7014
Water Bottle holder And Warmer Assembly EGA-7010
Pump Head EGA-7016
Foot Pedal EGA-7015
EGA-500E
Item Order Number
Power Cord (U.K.) EGA-7022
Power Cord (E.U.) EGA-7017
Power Cord (Aus.) EGA-7021
Water Bottle Holder And Warmer Assembly EGA-7010
Pump Head EGA-7016
Foot Pedal EGA-7015
The ENDO STRATUS® irrigation pump EGA-500 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 ocially recommended by MEDIVATORS. Use of the device with accessories not
identied in the table below or ocially recommended by MEDIVATORS may result in
incompatibility and/or the risk of cross-contamination and infection transmission.

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VI. Front Panel Controls/Connections
1. On/O Push Button
Turns main power on or o to the unit
2. Water Bottle Warmer On/O
Push to turn water warmer on or o
3. Pump Flow Control
The ow control knob is a continuous variable ow control that has settings between 0 and 100% ow.
The lowest knob setting corresponds to no ow while the max ow control setting represents 100% ow. It
contains bracketed visual iterations to represent ow magnitude in increasing increments of approximately 10%,
however the ow control knob response is not entirely linear. Incremental ow control knob increases between
50-100% have a larger impact on ow rate response as compared to incremental changes between 0-50%.
Flow Rates:
Auxiliary Water Channel 0-300 ml/min*
Biopsy Channel 0-650 ml/min*
*These values are approximate and are based on an average ow obtained with three dierent
manufacturer’s GI endoscopes with biopsy channel diameters ranging from 2.8 mm-4.2 mm and auxiliary
water channel diameters ranging from 0.8 mm-1.0mm. User results may vary depending on scope used,
channel size and working channel length.
4. Foot Pedal Connection
5. Prime Button
When pressed, pump will run for a period of 20 seconds. The cycle can be canceled at any time by either pressing
the foot pedal or prime button again. See Section VIII for full explanation.
6. Pump Head
Refer to Section VIII for assembly instructions
(The appearance of your device may dier slightly from picture shown above)
1
2
6
3
4
5
Note: All status indicator lights will be green during normal operation.
NOTE:
The ENDO STRATUS® irrigation pump is intended for use only by physicians/clinicians
who are trained regarding the amount of water to use for irrigation and infusion during
GI endoscopic procedures.
CAUTION:

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VII. Rear Panel Connections
1. Water Bottle Warmer Connection
Power connection for water bottle warmer
2. Equipotentiality (Earth Ground)
3. AC Power Connection
AC power input 100-240 VAC, 50-60HZ
4. Fuse Receptacle
5. Water Bottle Holder And Warmer
The water bottle holder contains the heating element and an integral hold-down bracket to secure the water bottle
in place.
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:
512
3
4
(The appearance of your device may dier slightly from picture shown above)

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VIII. Setup And Operation
Initial Setup
1. Before beginning, inspect the ENDO STRATUS® irrigation pump for any signs of damage.
2. Install the pump head onto the device by aligning the flat shaft on the front of the device with the slotted hole in
the pump head and rotate the pump head until it locks in place.
3. 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 irrigation pump on the base tray and install the (2) long screws using the
large hex key.
D. Adjust the water bottle hold-down bracket to fit 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.

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4. Plug the water warmer cable into the receptacle marked “water warmer” on the back of the unit.
5. Place the ENDO STRATUS® irrigation pump on a flat surface such as an endoscope accessory cart or other
suitable working surface.
6. Before connecting the power cord to the hospital grade wall receptacle, make sure the power is off to the device,
and no accessories are connected.
7. Connect the power cord to the back of the device.
Pre-Procedure setup
1. Place the foot pedal on the floor and insert the foot pedal cord into the designated front panel receptacle.
2. Insert a water bottle containing sterile water into the water bottle holder
Adjust the hold-down bracket by loosening the knob, lowering the bracket until it contacts the top of the bottle
and then tightening the adjusting screw. After initial setup, if the same size and type of bottle is used, it should
require no further adjustment.
3. Open a sterile pouch of the 100130 ENDOGATOR® irrigation tubing or 100609 ENDOGATOR® hybrid tubing. Read
and follow its instructions for use.
4. Connect the tubing to the water bottle.
5. Open the pump head and place the tubing into the pump head rollers so that the water flow will be from right to
left facing the pump.
6. Turn the flow rate indicator to its lowest speed and turn the unit on.
7. Perform the following procedure to ensure the tubing is fully filled with sterile water each time before connecting
to a GI endoscope:
A. Direct the end of the tube into a receptacle capable of catching expelled water.
B. Depress the foot switch and turn up the flow rate adjustment to the desired level based on the
irrigation connection to the GI endoscope.
PRIME FUNCTION: The prime function allows the user to perform this feature with the assistance of an automatic
timer in lieu of pressing the foot pedal. Pressing the prime button will run the pump for a period of 20 seconds. If at
any time the prime cycle needs to be stopped the button can be pressed again, or the foot pedal can be pressed.
The prime function is not intended to be a denite means of fully priming the tubing. It is the
responsibility of the end user to ensure the tubing and GI endoscope channel are fully lled with
water before proceeding.
8. When priming is complete, attach the irrigation tube set to the GI endoscope using the proper adapter for the
endoscope model and endoscope channel. (See Section V for a complete list of irrigation tubing and
adaptors for various GI endoscopes.)
9. The ENDO STRATUS irrigation pump is now ready to use.
Use of irrigation uid other than sterile water can pose an infection risk to patients.
CAUTION:
NEVER allow the sterile water bottle to empty completely to avoid air entering the
irrigation tubing.
CAUTION:
NOTE:
The device is equipped with a safety feature so that the pump will not operate if the pump head is open.
The ENDO STRATUS irrigation pump EGA-500 and EGA-500E is intended to be used only with
specic models of compatible tubing sets, connectors and accessories identied in the table in
Section V or ocially recommended by MEDIVATORS. Use of the device with accessories not
identied in the accessories table or ocially recommended by MEDIVATORS may result in
incompatibility and/or the risk of cross contamination and infection transmission.
CAUTION:

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Water Pre-Warming
1. The ENDO STRATUS® irrigation pump has an integral water warming system that can maintain the
temperature of the water at up to 37 ± 3°C.
2. Place sterile water bottle in a fluid warming oven set to 37°C for at least 2 hours until the water has been warmed to
at least 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.
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.
Operation
1. Water flow is initiated by pressing the foot pedal and releasing when no longer desired.
2. If more water flow is required, increase the flow control setting on the front panel. Refer to Section VI for flow rates.
The physician must assess the condition of the patient and use clinical judgment to
set the ow rate from the pump to a suitable level to avoid patient trauma. The ow
control should always be set at the lowest setting at the start of the procedure and
be increased incrementally to a level commensurate with the clinical condition of
the patient and the degree of irrigation required.
Shutdown
1. Press the power button to turn the unit off. The light should extinguish.
2. If the warming element has been activated, press the power button for the warmer to turn off. The blue light
should extinguish.
3. After the procedures are complete for the day, remove the tubing from the pump head and discard the tubing and
water bottle.
CAUTION:
The surface of the water bottle warmer may be hot to the touch.
NOTE:
ENDOGATOR® Irrigation tubing may be used for 24 hours.
NOTE:
The system is not intended to raise the temperature of the water; therefore pre-warming of the water
bottle is required.
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 o. 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
customer service at 800-444-4729.
NOTE:
The device is equipped with a safety feature so that the pump will not operate if the pump head is open.
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.
CAUTION:

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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 ENDO STRATUS® irrigation pump can be cleaned with a damp cloth, 70% isopropyl
alcohol solution, or a 10% bleach with water solution as often as deemed necessary.
• Do not use abrasive or harsh cleaners.
• Do not allow liquid to enter the unit.
• To disinfect the outside surface, use a mild disinfectant according to the manufacturer’s instructions.
• Do not sterilize the unit by any means.
Maintenance
Pump Head Maintenance
If liquids are spilled onto the pump head, it should be removed and cleaned with a mild detergent. Remove any tubing from
the pump head prior to removal for cleaning.
The same cleaning procedure should be used to limit the build-up of dust (which can become electrostatically charged and/
or heated by friction).
Servicing
The unit is not user serviceable. 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 specifications (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: fifteen (15) months from date of shipment
from the Company or one (1) year from the date of installation, whichever occurs first.
Consumables, accessories, and Product service parts, including, but not limited to, endoscope hook-ups, filters,
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 first.
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 filters 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 official “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.
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 LIMITA-
TION, 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 LIMITED SOLELY TO REPAIR, REPLACEMENT OR REFUND OF THE
PURCHASE PRICE AS SET FORTH IN THIS WARRANTY STATEMENT.

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X. Electromagnetic Compatibility (EMC) Information
Table 1 – Guidance And MANUFACTURER’S Declaration
ELECTROMAGNETIC EMISSIONS
For All ME EQUIPMENT And ME SYSTEMS
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided in this section.
Portable and mobile RF communications equipment can aect 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.
The use of accessories, transducers and/or cables other than those specied, with the exception of those
sold by the manufacturer as replacement parts for internal components, may result in increased emissions
or decreased immunity of the equipment or system.
The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is neccessary, the equipment or system should be observed to verify normal operation in the
conguration in which it will be used.
The EGA-500/EGA-500E is intended for use in the electromagnetic environment specied below. The
customer or user of the EGA-500/EGA-500E 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-500/EGA-500E 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.
Guidance and Manufacturer’s Declaration – Emissions
The EGA-500/EGA-500E is suitable for use in all estab-
lishments, other than domestic, and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
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 specific 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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EN/IEC 60601
Test Level
The EGA-500/EGA-500E is intended for use in the electromagnetic environment specied below. The
customer or user of the EGA-500/EGA-500E should ensure that it is used in such an environment.
Table 2 – Guidance And MANUFACTURER’S Declaration
Electromagnetic IMMUNITY
For All ME EQUIPMENT And ME SYSTEMS
Immunity Test Electromagnetic Environment – Guidance
Compliance
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
>95% Dip for
0.5 Cycle
60% Dip for
5 Cycles
30% Dip for
25 Cycles
>95% Dip for
5 Seconds
Mains power quality should be that of a
typical commercial or hospital environment. If the user
of the EGA-500/EGA-500E requires continued operation
during power mains interruptions, it is recommended
that the EGA-500E be powered from an uninterruptible
power supply or battery.
±1kV Dierential
±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 Dierential
±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
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity
±6kV Contact
±8kV Air

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Table 3 – Guidance And MANUFACTURER’S Declaration
Electromagnetic IMMUNITY
For ME EQUIPMENT And ME SYSTEMS That Are Not LIFE-SUPPORTING
Immunity Test
Conducted RF
EN/IEC 61000-4-6
Radiated RF
EN/IEC 61000-4-3
Compliance
Level
(V1)Vrms = 3
Vrms
(E1)V/m = 3 V/m
Electromagnetic Environment – Guidance
EN/IEC 60601
Test Level
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Guidance and manufacturer’s declaration – Electromagnetic Immunity
The EGA-500/EGA-500E is intended for use in the electromagnetic environment speci-
ed below. The customer or user of the EGA-500/EGA-500E should ensure that it is used
in such an environment.
Portable and mobile communications equipment
should be separated from the EGA-500/EGA-500E 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 recom-
mended 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.

IFU-51 / REV G
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Separation (m)
800MHz to 2.5GHz
D=(7/E1)(Sqrt P)
Max Output
Power
(Watts)
Separation (m)
80 to 800MHz
D=(3.5/E1)(Sqrt P)
0.01
0.1
10 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-500/EGA-500E is intended for use in the electromagnetic environment in which radiated
disturbances are controlled. The customer or user of the EGA-500/EGA-500E can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile
RF communications equipment and the EGA-500/EGA-500E as recommended below, according to the
maximum output power of the communications equipment.
Recommended Separations Distances for the EGA-500/EGA-500E
.1166
Separation (m)
150kHz to 80MHz
D=(3.5/V1)(Sqrt P)
Table 4 – Recommended Separation Distances Between Portable And Mobile
RF Communications Equipment And The ME EQUIPMENT Or ME SYSTEM
For ME EQUIPMENT And ME SYSTEMS That Are Not LIFE-SUPPORTING
Approved accessories
Type
Power cable
Manufacturer/Model
Interpower/86610610
Maximum length
3.7m
1

IFU-51 / REV G
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Bedienungsanleitung Spülpumpe für die
gastrointestinaleEndoskopie
MODELL: EGA-500E
MODELL: EGA-500
Ausgabedatum: 15.07.2013
ENDOGATOR®, DEFENDO®, Y-OPSY®, MEDIVATORS® und ENDO STRATUS® sind eingetragene Marken von Medivators Inc.
FUJIFILM™ ist eine Marken der FUJIFILM Corporation.
OLYMPUS® ist eine eingetragene Marke der Olympus Corporation.
PENTAX® ist eine eingetragene Marke der Hoya Corporation.
www.medivators.com
Hergestellt in den USA von:
Medivators
3150 Pollok Drive
Conroe, TX 77303
USA
Tel.: [phone]
Medivators Inc. Headquarters
14605 28th Avenue North
Minneapolis, MN 55447 USA
Tel. (gebührenfrei): +1.800.444.4729
0050
Medivators BV
Sourethweg 11
6442 PC Heerlen
Niederlande
Tel.: [phone]
Irrigation Pump

IFU-51 / REV G
DE - 2
Inhaltsverzeichnis
I. Auspacken und Prüfung des Inhalts.....................................................................................3
II. Einführung..............................................................................................................................3
Begrisbestimmungen ..........................................................................................3
Gebrauchsanweisung.............................................................................................3
Kontraindikationen................................................................................................3
III. Warnhinweise und Vorsichtsmaßnahmen: ..........................................................................4
IV. Produktbeschreibung............................................................................................................6
Funktionsweise.......................................................................................................6
V. Technische Daten ...................................................................................................................6
Elektrische Daten....................................................................................................6
Technische Daten....................................................................................................7
Durchuss ...............................................................................................................7
Umgebungsbedingungen .....................................................................................7
Zubehörteile ...........................................................................................................8
Ersatzteile................................................................................................................8
VI. Bedienelemente/Anschlüsse Front-Bedienfeld...................................................................9
VII. Anschlüsse auf der Rückseite..............................................................................................10
VIII. Vorbereitung und Verwendung..........................................................................................11
Ersteinrichtung.....................................................................................................11
Vorbereitungen vor derVerwendung.................................................................12
Wasservorwärmung .............................................................................................13
Betrieb...................................................................................................................13
Ausschalten des Geräts........................................................................................13
IX. Pege und Wartung .............................................................................................................14
Reinigung..............................................................................................................14
Wartung.................................................................................................................14
X. Elektromagnetische Verträglichkeit (EMV)........................................................................15