EGA-501 SERIES SERVICE MANUAL
Contents
1. Connect the Water Bottle Warmer to the Water Warmer on the back of the EGA 501 Power Supply Replacement Tools Required Phillips Screwdriver 3 32 inch Hex wrench 1 Disconnect the unit from power wall outlet N Remove the cover of the unit Refer to the cover removal instructions in Cover Removal Section 3 Remove the Power Supply Assembly screws 2 each side See figure 1 Figure 1 4 Turn the Power Supply Assembly over to access the connections 5 Disconnect the three AC input wires and the two DC output wires noting their location on the Power Supply See figures 2 40 6 Figure 2 Wire Power Supply Terminal 1 Ground Green and yellow Ground 2 Neutral white ACN 3 Hot 100 VAC to 240 VAC Black ACL 4 Ground DC Black COM Note location in figure 2 5 24 VDC Yellow V Note location in figure 2 6 Indicator LED N A Remove four 4 hex screws that secure the Power Supply to the mounting bracket Cay Note Do not lose the four 4 standoffs and hex screws They will be needed to install the new Power Supply Using the standoffs and hex screws mount the new Power Supply to the mounting bracket Be sure the Power Supply is orientation correctly 8 Attach the wires as indicated in figure 2 Install the mounting bracket and secure with the four 4 mounting bracket hex screws Reinstall the cover 41 CO Manifold Replacement CO Manifold Removal Tools required2. Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in EMC Tables Section 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 Product Features Features Internal CO warmer eliminates cold CO Built in water bottle warmer maintains water at up to 37 C with an allowable tolerance of 3 C Stackable with the ENDO STRATUS Irrigation Pump e Standard male luer lock output e Uses standard D or E size CO cylinders e Accepts input from wall CO with standard DISS type connection e Usable at CO input pressures lower than most comparable units making efficient use of tank supply e Works with disposable ENDO SMARTCAP and ENDOGATOR hybrid tubing for safety and compliance Safety Features e Dual inline pressure regulators ensure a constant pressure e Two additional mechanical pressure reliefs at lt 75 PSI and lt 12 PSI prevents overpressure e Low CO input pressure is indicated by a yellow light on the front panel e On initial power up gas flow is off until the flow knob is turned on e CQO warmer will not operate unless flow is initiated Technical Specifications Electrical Specific
3. Section 6 Disconnect all wiring connectors from the Control board Mark them as needed to ensure they are attached to the correct location on the new board You can also refer to nsufflator Components Control Board Section figure 1 7 Remove the four 4 Phillips screws that secure the Control Board to the chassis and remove the board from the machine Control Board Installation SE Note When handling the Control Board be sure to take proper ESD precautions to ensure the board isn t damaged 1 Lubricate the inside of the Pressure Sensor Tubing with alcohol This will allow for easier connection to the Pressure Sensor 2 Before the alcohol dries install the tubing by using a twisting action while pressing the tubing onto the pressure sensor Use care as the pressure sensor is fragile 3 Install a zip tie to the pressure sensor figure 1 Use a zip tie gun to secure and trim it Ensure the zip tie is below the barb of the pressure sensor Use the zip tie gun with care making sure to allow the gun to only contact the sensor and not put excess strain on the sensor 48 Figure 1 4 Use the four 4 screws from the Control Board removal section to mount the board to the standoffs on the chassis The pressure sensor must be facing toward the front of the unit 5 Install the COz Manifold Assembly per the manifold installation instructions in in Component Replacement CO2 Manifold Replacement Section Set the
4. Components Internal Components CO Outlet CO Heater Flow Valves 12 psi Pressure Relief Valve 8 psi Low Pressure Regulator 75 psi Pressure Relief Valve 50 psi High Pressure Regulator Control Board Power Entry Module 0 CO Inlet 2 0900 NDN eS eS e gt i Note Components 3 through 7 are part of the Manifold Assembly and are not orderable separately 27 Power Supply Description The Insufflator Power Supply is a 150 watt medical grade power supply that is capable of operating at input voltages from 100 VAC to 240 VAC The Power Supply outputs 24 VDC to the Control Board It has an indicator LED that indicates proper operation Wire 1 Ground Green and yellow 2 Neutral white 3 Hot 100 VAC to 240 VAC Black 4 Ground DC Black 5 24 VDC Yellow 6 Indicator LED Power Supply Terminal Ground ACN ACL COM Note location in figure 2 V Note location in figure 2 N A 28 Control Board mx ae oe wow H U10 ei ee 2 a 3 sen D Er ER gt Bi o Figure 1 Connection Description J1 2 pins 24 VDC Cable from the Power Supply J2 2 pins Power Switch LED front panel J3 ribbon cable CO Flow Control Switch front panel J4 ribbon cable CO Flow Control LED Ribbon Cable J5 4 pins CO Flow Valves manifold J6 4 pins CO Heater Switch front panel J7 4 pins CO Temperature Sensor J8 2 pins CO gt Heater J9 4 pins H20 Switch front panel J10 4
5. Knob to the first position L will illuminate for LOW If a higher flow 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 flow rate accordingly 3 If warming of the CO is desired press the button for the CO 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 Gl endoscopic system to manually distend the gastrointestinal tract with CO2 Shutdown 1 When the procedure is over turn the Flow Control Knob counter clockwise until all lights are off turn off the Water Bottle Warmer if attached and turn off the CO 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 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 ora 10 bleach with water solution as often as deemed necessary
6. Phillips screwdriver e 5 64 hex wrench e 30 120 inch pound torque wrench with a 7 16 inch attachment Disconnect the unit from power wall outlet Remove the cover as outlined in Cover Removal Section Remove the Power Supply Assembly screws 2 each side See figure 1 Figure 1 4 Lift the Power Supply Assembly from the chassis and set alongside the machine using care not to strain the wires attached to the Power Supply 5 Remove the two 2 CO copper tubings that attach to the Manifold See figure 2 WARNING Never supply power to the unit unless the Power Supply is properly mounted in the machine Shock or Power Supply damage may occur Note It is recommended that you loosen the flare nuts on each end of the tubing before completely removing the flare nuts This will reduce stress to the tubing 42 Figure 2 6 Remove the four hex screws that secure the Manifold to the chassis See figure 3 Figure 3 43 7 Remove the Pressure Sensor Tubing from the quick connect fitting on the top of the Manifold See figure 4 You can achieve this by pressing the locking ring into the quick connect fitting while pulling the tubing from the fitting Take care not to stress the other end of the tubing that attaches to the Pressure Sensor on the Control Board Figure 4 Note You will not be able to remove the CO Flow Valve Connector from the J5 connection on the Control Board until after the manifold has been remove
7. Power Supply Assembly in place and secure with the four 4 Phillips screws Connect the machine to power Attach a female luer cap to the CO Output on the front of the machine Attach the CO2 supply to the COz Input on the back of the machine Open the CO supply valve and set the Flow Control to H This will pressurize the CO circuit Once the circuit has been pressurized shut off the CO2 supply valve and watch the CO supply pressure gauge the supply pressure gauge must be located on the machine side of the shutoff The CU pressure cannot drop by more than 10 psi in 30 seconds If it does there is an internal leak The leak must be repaired before proceeding 8 Attach the cover and secure with two 2 5 64 hex screws Power Switch Replacement Power Switch Removal Always replace the Power Switch Boot when replacing the Power Switch Tools required e Phillips screwdriver e 5 64 hex wrench e 7 8 inch wrench 1 Disconnect the unit from power wall outlet Remove the cover as outlined in Cover Removal Section Remove the Power Supply Assembly screws 2 each side See figure 1 49 Figure 1 Lift the Power Supply Assembly from the chassis and set alongside the machine using care not to strain the wires attached to the Power Supply Unplug the wire that routes from the Power Switch to the Power Entry Module Remove the wire that routes form the Power Switch to the ACL connection on the Power Supply Remove the Power Sw
8. 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 20 Electromagnetic Compatibillity EMC Information EMC Tables Table 1 Guidance And MANUFACTURER S Declaration ELECTROMAGNETIC EMISSIONS For All ME EQUIPMENT And ME SYSTEMS Guidance and Manufacturer s Declaration Electromagnetic Emissions The EGA 501 EGA 501E is intended for use in the electromagnetic environment specified below The customer or user of the EGA 501 EGA 501E should ensure that it is used in such an environment Emissions Test Compliance Electromagnetic Environment Guidance RF Emissions Group 1 The EGA 501 EGA 501E uses RF CISPR 11 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 RF Emissions Class A The EGA 501 EGA 501E is suitable for CISPR 11 use in all establishments other than domestic and those directly connected to Harmonics Class A the public low voltage power supply IEC 61000 3 2 network that supplies buildings used for domestic purposes Flicker 21 Table 2 Guidance And MANUFACTURER S Declaration Electromagnetic IMMUNITY For All ME EQUIPMENT And ME SYSTEMS Guidance and Manufacturer s Declaration Electromagnetic Immunity The
9. EGA 501 EGA 501E is intended for use in the electromagnetic environment specified below The customer or user of the EGA 501 EGA 501E should ensure that it is used in such an environment EN IEC Complianc Electromagnetic Environment Immunity Test 60601 e Level Guidance ESD EN IEC 61000 4 2 EFT EN IEC 61000 4 4 6kV Contact 8kV Air 2kV Mains 1kV I Os 6kV Contact 8kV Air 2kV Mains 1kV I Os Floors should be wood concrete or ceramic tile If floors are synthetic the r h should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Surge EN IEC 61000 4 5 Voltage Dips Dropout EN IEC 61000 4 11 1kV Differential 2kV Common gt 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles gt 95 Dip for 5 Seconds 1kV Differential 2kV Common 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 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 uninterruptible power supply or battery Power Frequency 50 60Hz Magnetic Field EN IEC 61000 4 8 3A m Power frequency magnetic fields should be
10. MEDIVATORS stratus CO Insufflator EGA 501 SERIES SERVICE MANUAL 2 MEDIVATORS Ge A Cantel Medical Company FUJINON is a trademark of FUJIFILM Corporation OLYMPUS is a registered trademark of OLYMPUS Corporation PENTAX is a registered trademark of Hoya Corporation ENDO STRATUS ENDO SMARTCAP ENDOGATOR DEFENDO and Y OPSY are registered trademarks of MEDIVATORS Inc MEDIVATORS is a registered trademark of MEDIVATORS Inc 50098 308 Rev A 2014 MEDIVATORS Inc All rights reserved This publication is protected by copyright Copying disclosure to others or the use of this publication is prohibited without the express written consent of MEDIVATORS Inc MEDIVATORS reserves the right to make changes in the specifications shown herein without notice or obligation Contact your MEDIVATORS representative or MEDIVATORS customer service for more information Table of Content Theory of Operation WEE 5 ao elei Deg 5 eieiei le Weer 6 El lee Geier 6 ee 9 RK le Weier Le 10 Mechanical Specifications d etsdete eg d ebe ugeet Senden ed eh 10 Accessory temsa E 12 Controls amp Connections E 13 Setup amp Operation EE 16 Care amp Ela E lee 20 Electromagnetic Compatibility EMC Information 0 00 00 eeeeeeeeeeeeeeeeeeeeeeeeeee 21 Cover Removal 20092 25 Insutilator Components ege 27 Power EE 28 Control Board Ze 29 Pump tray amp Water Bottle Warmer eee 30 Troubleshooting 22 31 Unit will no
11. Note location in figure 2 6 Indicator LED N A 14 Verify the green LED is lit on the Power Supply See figure 6 Item 6 If not replace the Power Supply 15 Using a DMM verify there is 24VDC at the J1 connector on the Control Board If 24V DC is present replace the Control Board 34 Power Switch LED is Flashing The flashing Power Switch LED indicates an incorrect operating voltage Perform the following steps in the order specified 1 Verified the Power Switch latches in the ON position 2 Unplug the machine from the wall outlet and check continuity of the Power Switch a Unplug the Power Switch wire from the Power Entry Module See Troubleshooting Unit will not Power On Section figure 4 b Disconnect the Power Switch wire from the Power Supply See Troubleshooting Unit will not Power On Section figure 3 c Connect a DMM between the two wires See figure 5 in Troubleshooting Unit will not Power On Section d Depress the Power Switch on the front of the unit An acceptable reading is less than 25 ohms If you get a reading greater than 25 ohms replace the Power Switch 3 Verify the green LED on the Power Supply is lit See Troubleshooting Unit will not Power On Section figure 6 item 6 If not replace the Power Supply 4 Using a DMM verify there is 24VDC at the P1 connector that routs from the Power Supply to the Control Board If 24 VDC is present replace the Control Board Water Heate
12. R SWITCH NOT ILLUMINATED Water Heater Power switch is OFF ILLUMINATED GREEN Water Heater Power switch is ON ILLUMINATED FLASHING BLUE Indicates an Error Water heater temperature sensor is detecting an over temp condition or the heater cable is disconnected from the back of the insufflator CO FLOW CONTROL SWITCH NOT ILLUMINATED Switch set below the L Low position ILLUMINATED L M or H Insufflator is powered on and L low M Medium or H High has been selected 15 FLASHING ILLUMINATED LOW PRESSURE Supply CO pressure is too low lt 25 PSI or turned off 4 CO HEATER SWITCH NOT ILLUMINATED CO heater is turned OFF ILLUMINATED GREEN CO heater is turned ON ILLUMINATED BLUE Error CO is detecting an over temp condition or a low CO2 pressure has been detected and the heater has been deactivated Setup and Operation Initial Setup 1 Place the MEDIVATORS ENDO STRATUS CO2 Insufflator on a flat surface such as an accessory cart or other suitable working surface Before beginning inspect the ENDO STRATUS CO insufflator for any signs of damage Connect the power cord to the back of the device 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 Assemble the water bottle holder and warmer assembly in the following manner A The following supplies are ne
13. ates shown are maximum free flow measurements at output of unit Low gas pressure is indicated by the words LOW PRESSURE flashing to notify the user that the gas input pressure has fallen below 25PSI 4 CO gas output connector Connect to tubing and GI endoscope Standard male luer lock connector 5 CO gas heater On Off Push to toggle CO gas heater On or Off 13 Rear Panel Connections The appearance of your device may differ slightly from picture shown above 1 Water Bottle Warmer connection Power connection for water bottle warmer 2 CO input connection For connecting a D or E sized CO tank Use only pre filtered medical grade CO gas 3 Equipotentiality Earth Ground 4 AC power connection AC power input 100 240 VAC 50 60HZ WARNING Use only the hospital grade power line cord supplied with A this unit Connect only to a power receptacle marked as hospital grade 5 Fuse Receptacle A WARNING Replace only with type and rating marked M10AL250V 14 6 Water Bottle Holder and Warmer The water bottle holder contains the warming system for the water bottle and connects to the MEDIVATORS ENDO STRATUS CO Insufflator by means of an electrical cable which plugs into the receptacle marked Water Warmer Description of indicator lights on front panel 1 POWER SWITCH NOT ILLUMINATED Main power is turned OFF ILLUMINATED GREEN Main power is turned ON WATER HEATER POWE
14. ations 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 Certifications IEC 60601 1 IEC 60601 1 2 IEC 60601 2 18 Classification Class 1 Type B IP Rating Ingress Protection IP24 Warning Grounding reliability can only be achieved when connected to a receptacle marked Hospital Grade Mechanical Specifications Physical Dimensions Physical Dimensions Height 4 3 4 inches 121 mm Width 7 3 4 inches 197 mm Depth 13 3 4 inches 349 mm Weight 10 5 pounds 4 8 kg CO Specifications 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 endoscope Flow Rates approximate flow 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 Gl endoscope used channel diameter and channel length Output Connection Male luer lock Input Connection 1 4 male flare fitting CO Heater 20W internal flow through with dual redundant temperature sens
15. by physicians clinicians who are trained regarding the amount of water to use for irrigation and infusion Only qualified medical personnel in an acceptable medical facility should operate the ENDO STRATUS CO Insufflator The ENDO STRATUS CO Insufflator should be connected to a properly grounded receptacle marked Hospital Grade or Hospital Only otherwise grounding reliability cannot be achieved Extreme precaution must be taken when handling liquids around electrical equipment DO NOT operate the ENDO STRATUS CO Insufflator if liquid has been spilled on the unit The ENDO STRATUS irrigation pump should not be used adjacent to or stacked with other equipment other than another ENDO STRATUS CO Insufflator device Electromagnetic or other interference may occur between the ENDO STRATUS CO Insufflator 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 The ENDO STRATUS CO Insufflator should only be used in conjunction with other equipment whose safety against leakage currents has been established The instructions contained in the operating manuals of any equipment to be used in conjunction with ENDO STRATUS CO Insufflator must be followed to avoid any possible hazard from incompatibility The instructions for use described in this manual MUST be followed Otherwise compromised safety malf
16. cessary and can be found in a bag attached to the water bottle holder see figure 1 a Short Screws 2 b Long Screws 2 c Large Hex Key d Small Hex Key Figure 1 B Attach the water bottle holder to the base tray using the 2 small screws and small hex key See figure 2 16 Figure 2 C Place the ENDO STRATUS CO Insufflator on the base tray and install the 2 long screws using the large hex key See figure 3 Figure 3 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 6 Plug the water warmer cable into the receptacle marked Water Warmer on the back of the unit 17 CO hose attachment Tools required 9 16 open end wrench 3 4 open end wrench Accessories required D or E size CO tank filled with medical grade CO not included High pressure hose Yoke adapter 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 Unscrew the T handle on the yoke to allow it to slip over the top post of the CO tank The correct orientation is so that the two pins on the yoke line up with the two alignment holes on the tank CO tank is not included with system purchase separately After aligning th
17. d from the unit 8 Carefully lift the Manifold Assembly from the machine taking care not to strain the CO2 Flow Valve wires Once the Manifold has been lifted out of the machine disconnect the CO Flow Valve wires from the J5 connector on the Control Board and discard CO Manifold Installation 1 Connect the CO Flow Valve Connector to the J5 connection on the Control Board 2 Set the new Manifold Assembly in the chassis and secure it to the chassis with four hex head screws that were removed in Step 6 See figure 3 of the previous section Note Use the upper set of holes in the chassis 4 to mount the Manifold Assembly to the chassis 3 Attach the two 2 CO2 copper tubings to the Manifold Thread each flare nuts until snug then torque each flare nut to 90 inch pounds Insert the Pressure Transducer Tubing into the quick connect fitting on the top of the Manifold Set the Power Supply Assembly in place and secure with the four 4 screws 44 6 Connect the machine to power Attach a female luer cap to the CO2 Output on the front of the machine Attach the CO2 supply to the CO Input on the back of the machine Open the CO2 supply valve and set the Flow Control to H This will pressurize the CO circuit Once the circuit has been pressurized shut off the CO supply valve and watch the CO supply pressure gauge the supply pressure gauge must be located on the machine side of the shutoff The CO pressure cannot drop by more t
18. e J8 connection on the control board Disconnect the CO Heater ground wire from the ground lug on the back wall of the chassis 10 Remove the three 5 16 inch nuts that secure the CO Heater Mounting Plate to the chassis and remove the CO Heater Assembly from the machine 11 Remove the two 2 3 8 inch nuts that secure the CO Heater to the Mounting Plate 12 Discard the defective CO Heater but retain the Mounting Plate CO Heater Installation 1 Install the CO2 Heater to the Mounting Plate with the Temperature Sensor orientated as indicated in figure 1 2 Slide the Heater as indicated in figure 1 and secure with two 2 3 8 inch nuts from the CO Heater Removal Section Figure 1 3 Secure the CO2 Heater Assembly to the chassis using the three 3 5 16 in nuts from the Heater Removal section 4 Attach the Ground Wire to the ground lug on the back wall of the machine 46 10 ki Connect the CO2 Temperature Sensor wires to J7 on the Control Board Connect the CO Heater wires to J8 on the Control Board Connect the CO Heater Tubing that routes from the CO Heater outlet to the CO Output on the front of the machine Tighten the 7 16 inch flare nuts until snug then torque to 90 inch pounds Install the CO Manifold Assembly per the manifold installation instructions in Component Replacement CO Manifold Replacement Section Set the Power Supply Assembly in place and secure with the four 4 Phillips
19. e cscs tee 55 Re NEE 55 e EE 57 Theory of Operation The MEDIVATORS ENDO STRATUS CO Insufflator works by regulating CO from a tank source to a preset pressure and then controlling the output of CO2to a 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 CO3 The ENDO STRATUS CO insufflator contains a CO warming feature that allows the clinician to modulate and control delivery of CO to the patient that has been warmed to a target temperature of 37 C with an upper tolerance of 3 C Warming is achieved as CO flows across a heating element which can be switched on or off by the user depending on if warming of the COz is desired The heating of the COz is accomplished through an internal 20W heating element with dual redundant temperature sensors The flow rate can be adjusted to low medium or high settings depending on the desired rate of insufflation with flow 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 flow and heating function are off by default To initiate gas flow the user must turn the flow setting knob from the oft position The unit will detect gas flow and will not allow the heater to operate unless gas flow is detected In addition there is a low gas pressure
20. e the mounting nut that secures the CO Heater Switch to the chassis Remove the CO Heater Switch Assembly from the machine CO Heater Switch installation 1 Insert the wires from the CO Heater Switch through the opening in the front of the chassis and the mounting nut Secure the CO Heater Switch to the front wall by using a 7 8 inch wrench to tighten the mounting nut Connect the wires from the CO Heater Switch to the J6 connector on the Control Board Set the Power Supply Assembly in place and secure with the four 4 Phillips screws 5 Attach the cover and secure with two 2 5 64 hex screws 51 Flow Control Assembly Replacement Flow Control Assembly Removal Tools required Phillips screwdriver 5 64 hex wrench 7 16 wrench Pliers 050 gap gauge Disconnect the unit from power wall outlet Remove the cover as outlined in Insufflator Components Section Remove the Power Supply Assembly screws 2 each side See figure 1 Figure 1 Lift the Power Supply Assembly from the chassis and set alongside the machine using care not to strain the wires attached to the Power Supply Use the 5 64 hex wrench to loosen the set screws on the Flow Control Assembly Knob and then remove the knob Using a 7 16 inch wrench remove the Rotary Encoder nut Slide the Rotary Encoder into the machine and disconnect the ribbon cable from the J3 connection on the board See figure 2 Disconnect the Flow Control I
21. e two pins tighten the T handle firmly Tighten the other end of the high pressure hose and yoke assembly to the back of the ENDO STRATUS CO Insufflator Hold the brass fitting 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 a 2 3 Open the valve on the CO tank approximately 1 turn Turn the power switch to On Test the setup by turning the flow control knob position clockwise Verify that there is CO2 flowing out the front output of the unit If there is no CO2 observed out the front of the unit verify that the CO tank is full and check the connection outlined in CO hose attachment above Turn off the flow control knob Connect the tubing to the front output of the device Use only ENDO SMARTCAP tubing or ENDOGATOR hybrid tubing manufactured by MEDIVATORS 18 When using ENDO SMARTCAP CO 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 Water Pre Warming 1 The ENDO STRATUS CO Insufflator 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 t
22. g a wrench If loose replace the CO gt heater e With CO pressure applied check all components on the CO Manifold for leaks e If all of the above have tested good replace the CO2 Manifold Low pressure light keeps blinking The low pressure light on the Flow Control is continuously flashing indicating that the COz input pressure has fallen below 50 psi e Verify input pressure is greater than 100 psi by installing a pressure gauge in line at the rear CO input connection and opening the CO supply e Check the pressure transducer on the control board by removing the hose from the regulator manifold connection black push to connect and applying a syringe to the open end of the tube Squeeze the syringe to create pressure if the LOW PRESSURE light does not turn off the pressure transducer is defective Replace the control board 36 Water Heater Switch LED is flickering blue or green e Check the wiring on the Water Heater switch to make sure the wires are fully inserted in the white connector and the connector is fully installed in J9 on the Control Board Power Supply Light is flashing A 120 240 VAC is present e With the unit plugged in and the Power Switch depressed to the ON position verify that you are reading source voltage 100 VAC to 230 VAC between the neutral ACN and source voltage connection ACL on the power supply See figure 1 e If the correct source voltage 100 VAC to 230 VAC is not present check t
23. han 10 psi in 30 seconds If it does there is an internal leak The leak must be repaired before proceeding 7 Attach the cover and secure with two 2 5 64 hex screws CO Heater Assembly Replacement e Tools required e Phillips screwdriver e 5 64 hex wrench e 30 120 inch pound torque wrench with a 7 16 inch attachment e 5 16 inch nut driver e 3 8 inch wrench CO Heater Removal 1 Disconnect the unit from power wall outlet 2 Remove the cover as outlined in Cover Removal Section 3 Remove the Power Supply Assembly screws 2 each side See figure 1 Figure 1 4 Lift the Power Supply Assembly from the chassis and set alongside the machine using care not to strain the wires attached to the Power Supply 45 0 Note Never supply power to the unit unless the Power Supply is properly mounted in the machine Power Supply damage may occur 5 Remove the CO Manifold Assembly per the CO Manifold Removal instructions Component Replacement CO Manifold Replacement Section 6 Remove the CO Heater Tubing that routes from the output of the CO2 Heater to the CO2 Output Connection on the front of the machine Note It is recommended that you loosen the flare nuts on each end of the tubing before completely removing the flare nuts This will reduce stress to the tubing and fittings Disconnect the CO2 Temperature Sensor wires from the J7 connector on the Control Board Disconnect the CO Heater wires from th
24. he continuity of the Power Switch front panel See Troubleshooting Unit will not Power On Section Replace the Power Switch if it is defective Neutral Source Voltage 100 VAC to 240 VAC Figure 1 e Disconnect the machine from power wall outlet then disconnect Power Supply Cable from the J1 connector on the Control Board Reconnect the machine to power and press the Power Switch to turn the unit back on If Power Supply LED is still flashing replace Power Supply 37 CO heater switch LED turns blue while CO is flowing e Verify CO input pressure is at least 100 PSI SED Note The CU Heater is designed to only function while the flow setting is on L M or H e Test for the problem by running the unit on H and if the light turns blue replace the circuit board CO flow is not correct according to Low Medium High settings e Check the Flow Valves on the regulator for broken or missing wires If wires are missing or broken replace the CO Manifold assembly e f the wiring is good ensure the LEDs on the circuit board light up as follows Flow Setting LED illuminated L D13 M D12 H D11 e If the LEDs are lighting up correctly using a DMM ensure 12VDC exists on terminals 1 2 and 3 4 of the J5 connector with the flow on H If not replace the circuit board CO temperature is not rising when CO heater is turned on e Check for 24V at CO Heater connection J8 Also verify LED D25 on Control Board is lit when
25. he 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 58 59 SB MEDIVATORS A Cantel Medical Company Manufactured in the USA by MEDIVATORS BV ECIREP MEDIVATORS Asia Pacific Pte Ltd MEDIVATORS Beijing Representative Office MEDIVATORS Inc Headquarters 14605 28th Avenue North Sourethweg 11 1A International Business Park Room 708 7th Floor Kaiheng Center Block B Minneapolis MN 55447 USA 6422PC Heerlen 05 01 Singapore 609933 No 2 Chaoyangmennei Street Toll Free 1 800 444 4729 The Netherlands Tel 65 6227 9698 Dongcheng District Beijing China 100010 Tel 31 45 5 471 471 Tel 8610 6567 8446 www medivators com
26. he water bottle is required The water bottle must be pre warmed with a method such as a fluid warmer if warm water is desired Water bottle pre warming should be performed according to the following instructions Place sterile water bottle in a fluid warming oven set to 37 C 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 Ee 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 flashing blue ensure the Water Warmer Cable is plugged into the back of the unit If it is connected and the light is flashing this may indicate a problem with the unit Contact MEDIVATORS Technical Support at 800 444 4729 Be Read and become familiar with all manufacturers instructions on warming ovens and water bottles regarding maximum fluid 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 A CAUTION The surface of the Water Bottle Warmer may be hot to the touch 19 Operation 1 After the pre procedure setup has been completed flow can be initiated 2 Turn the Flow Control
27. itch LED connector form the J2 connector on the Control Board Use a 7 8 inch wrench to remove the mounting nut that secures the Power Switch to the chassis Remove the Power Switch Assembly and nut from the machine Power Switch Installation 1 Ch SS En A Insert the power wires and the LED connector through the Power Switch opening in the front of the chassis and through the mounting nut Thread the mounting nut onto the Power Switch and use a 7 8 inch wrench to tighten securely Connect the power wire with the spade connection to the top connector on the Power Entry Module Connect the power wire with the ring terminal to the ACL connector on the Power Supply Connect the LED connector to the J2 connection on the Control Board Set the Power Supply Assembly in place and secure with the four 4 Phillips screws Attach the cover and secure with two 2 5 64 hex screws 50 CO Heater Switch Replacement CO Heater Switch Removal Tools required 7 Phillips screwdriver 5 64 hex wrench 7 8 inch wrench Disconnect the unit from power wall outlet Remove the cover as outlined in Cover Removal Section Remove the Power Supply Assembly screws 2 each side See figure 1 Figure 1 Lift the Power Supply Assembly from the chassis and set alongside the machine using care not to strain the wires attached to the Power Supply Remove the J6 connector from the Control Board Use a 7 8 inch wrench to remov
28. ndicator ribbon cable from the J4 connection on the control board See figure 2 Remove the Flow Control Indicator from the machine and discard 52 Flow Control Assembly Installation 1 Insert that Flow Control Indicator Ribbon Cable through the opening in the chassis 2 Insert the Rotary Encoder through the opening in the front wall and through the Flow Control Indicator 3 Secure the Rotary Encoder and Flow Control Indicator to the front wall with the nut and tighten until snug with a 7 16 in wrench 4 Attach the Rotary Encoder Ribbon Cable to J3 on the control board See figure 2 5 Attach the Flow Control Indicator Ribbon Cable to the J4 connection on the control board See figure 2 d _ Black traces face red connector C KS Sep Place flex cable into J4 Close lid of J4 Figure 2 6 Attach the Knob to the Rotary Encoder Shaft While holding the 050 gap gauge between the Nut and Knob and secure the two 5 64 set screws See figure 3 53 Figure 3 7 Set the Power Supply Assembly in place and secure with the four 4 Phillips screws 8 Attach the cover and secure with two 2 5 64 hex screws Carbon Dioxide CO Tank Basics 1 Use only U S P medical grade CO2 2 Only size D or E tanks are allowed Refer to your local gas supplier for size and capacity details 3 Read and understand all warnings that come with your commercially available tanks 4 The tank must remain in an up
29. ors CO Output Temperature 37 C 3 C Operating Pressure Input pressure 850 PSI Maximum 25 PSI Minimum The low pressure warning light will illuminate at 25 PSI although the unit may still flow It is recommended to replenish the C02 supply when the light illuminates Pressure regulator set point 8 PSI Maximum Internal safety relief valves lt 75 PSI and lt 12 PSI 11 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 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 12 Controls and Connections Front Panel ED Note All status indicator lights will be green during normal operation The appearance of your device may differ slightly from picture shown above 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 CQO2Flow control Controls flow rate of CO output The three levels are represented by three green indicators of L M and H which are illuminated to indicate the flow rate setting The flow rates are as follows Low 1 4L min Medium 2 4L min High 3 5L min Flow r
30. pins H2O Temp Sensors Water Warmer connection J11 2 pins H20 Heater Water Warmer connection U10 Pressure Sensor Board mounted pressure transducer 29 Pump Tray and Water Bottle Warmer 1 Tray 2 Water Bottle Warmer Assembly 3 Water Bottle Warmer Cable 30 Troubleshooting Unit will not power on Perform the steps below in the specified order Tools Required Digital Multi Meter DMM e Phillips screwdriver Eed Note Disconnect the power cord from the wall outlet before completing the following steps Remove the cover as outlined in Cover Removal Section 2 Verify that the Power Switch on the front of the machine was fully depressed causing it to latch on If the switch does not remain latched once it is fully depressed replace the Power Switch 3 Verify all wires are securely connected at the Power Supply Control Board and Power Entry Module 4 Verify appropriate voltage at the wall outlet 5 Verify the fuse is functional The fuse is located in the Power Entry Module on the back of the unit See figure 1 Remove the fuse and test resistance with a digital multimeter Replace if necessary e r re KNIGAL2S0V N WNarning Replace fuses only as marked Avertissement remplacer les fusles seulement tel qu indiqu Figure 1 6 Remove the Power Supply Assembly screws 2 each side See figure 2 31 Figure 2 7 Turn the Power Supply Assembly over to access the connection
31. r switch is illuminated solid blue rather than green In normal operation when the Water Heater Switch is activated the switch should be illuminated green in color If at any time the color changes to blue this is an indication of an error e Verify the Water Warmer Cable is connected to the rear of the machine If it is plugged in verify there is no damage to the pins e Replace the Water Bottle Warmer Assembly with a known good assembly if the light turns green replace the water bottle heater assembly e If the above steps do not solve the problem replace the Control Board 35 Low Medium High Indicators on the Flow Control Dial will not Illuminate e lf one or more selections on the Flow Control Dial do not light up check the connection of the CO Flow Control Switch Ribbon Cable J4 on the control board to ensure it is fully inserted into the header and the latch is pressed down See figure 1 Figure 1 e If problem still persists replace the CO3 Flow Control Switch Audible Internal CO Leak Detected e Check CO input connection at the back of unit to ensure it is tight no torque specified hand tighten using a wrench e Check all flare nut connections by tightening to 90 inch pounds e Visually inspect all copper tubing and flare nut connections for any cracks or signs of damage If any damage or cracks are found replace the copper tubing assembly Check all fittings for tightness on the CO Heater Assembly usin
32. right position when attached to the Insufflator to avoid damage to the internal regulator of the Insufflator 5 Keep CO tank away from any heat source 54 Parts List Part Number EGA 1015 EGA 1023 EGA 1035 EGA 1045 EGA 2013 EGA 2044 EGA 2045 EGA 2051 EGA 4019 EGA 4024 EGA 4025 Disposal Description Fuses 250V 10A Power Supply Rotary Encoder Control Board CO Manifold Tube Input Copper HP Tube Copper Low Pressure Tube Copper Output Indicator CO2 Flow Heater CO Heater Switch Assembly No special care is needed when disposing of the device 55 56 Limited Warranty 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
33. s 8 Disconnect the black wire that routes from the power switch to the ACL connection on the Power Board See figures 3 Wire from Power Switch to ACL connection on Power Board Figure 3 9 Then disconnect the wire that routes from Power Switch to the Power Entry Module See figure 4 32 Power Switch to Power Entry Module Source Voltage Wire Figure 4 10 Connect a DMM between the two black 115 230 VAC wires See figure 5 Depress the Power Switch on the front of the unit Verify that the switch latches in the ON position An acceptable reading is less than 25 ohms If you get a reading greater than 25 ohms replace the Power Switch Figure 5 33 11 Reattach the 115 230 VAC wires to the Power Supply figure 3 and Power Entry Module figure 4 12 Set the Power Supply in place and secure with mounting screws 4 See figure 2 13 Connect the machine to power and verify the correct voltage 100 VAC to 240 VAC is present at the Power Supply input terminals See figure 6 connections 2 and 3 If the correct voltage is not present check the Power Entry Module and Power Cord A 120 240 VAC present a A 5 ess 5 2 a j E e i TIS ES d F o 6 P R EEN Figure 6 Wire Power Supply Terminal 1 Ground Green and yellow Ground 2 Neutral white ACN 3 Hot 100 VAC to 240 VAC Black ACL 4 Ground DC Black COM Note location in figure 2 5 24 VDC Yellow V
34. screws from the Heater Removal procedure Connect the machine to power Attach a female luer cap to the CO Output on the front of the machine Attach the CO2 supply to the CO Input on the back of the machine Open the CO2 supply valve and set the Flow Control to H This will pressurize the CO circuit Once the circuit has been pressurized shut off the CO supply valve and watch the CO2 supply pressure gauge the supply pressure gauge must be located on the machine side of the shutoff The CU pressure cannot drop by more than 10 psi in 30 seconds If it does there is an internal leak The leak must be repaired before proceeding 12 Attach the cover and secure with two 2 5 64 hex screws Control Board Replacement Control Board Removal Tools required Phillips screwdriver 5 64 hex wrench 30 120 inch pound torque wrench with a 7 16 inch attachment Alcohol When replacing the control board you will also need to replace the Pressure Sensor tubing 1 2 3 Disconnect the unit from power wall outlet Remove the cover as outlined in Cover Removal Section Remove the Power Supply Assembly screws 2 each side See figure 1 47 Figure 1 4 Lift the Power Supply Assembly from the chassis and set alongside the machine using care not to strain the wires attached to the Power Supply 5 Remove the CO Manifold Assembly per the Manifold Removal instructions in Component Replacement CO2 Manifold Replacement
35. sensor and the unit will indicate when the input CO pressure reaches 25 PSI 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 C 3 C It is controlled by dual temperature sensors for redundancy and safety Definitions e Throughout this document the MEDIVATORS ENDO STRATUS CO Insufflator may be referred to as unit machine or device e mL min milliliters per minute flow e VAC Volts Alternating Current electrical potential e kPa kilo Pascal pressure e W Watts e VA Volt Amps Indications for Use The ENDO STRATUS CO Insufflator is designed to use CO as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope The ENDO STRATUS CO Insufflator contains a CO warming feature that allows the clinician to modulate and control delivery of CO to the patient that has been warmed to a target temperature 37 C Contraindications The MEDIVATORS ENDO STRATUS CO Insufflator should only be used by or under the direct guidance of a physician experienced in the standard practices of gastrointestinal endoscopy procedures It should only be used for procedures where insufflation of the gastrointestinal tract is necessary to support navigation of the GI endoscope and performance of any necessary e
36. 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 cu
37. stomer 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 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 LIMITED SOLELY TO REPAIR REPLACEMENT OR REFUND OF THE PURCHASE PRICE AS SET FORTH IN THIS WARRANTY STATEMENT 57 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 t
38. t power ON EE 31 Geen BB RE lee WEEN 35 Water heater switch is illuminated solid blue rather than green 1 1 1 1 35 Low medium high indicators on the flow control dial will not illuminate 36 Audible internal CO2 leak detected ccccccccecceneceeeceneeeeeeeneeeeeeeneeteeeenees 36 Low pressure light keeps blinking eeeEeEeEeEEEEEEEEEEKEEEEEEEEEEEEEEEEEEEEEEEEEEeen 36 Water heater switch LED is flickering blue or green ssec 37 Power supply is flashing e deto egsdategelg get ergelG nde dn d se e Za ee 37 CO2 heater switch LED turns blue while CO2 is flowing u ssseeeeeereee 38 CO2 flow is not correct according to Low medium high settings 38 CO2 temperature is not rising when CO2 heater is turned on 1 1 1 1 1 1 38 Water bottle warmer is not functioning ssssseeeeeeenennnnnnnn nn nn nn nerne nnnee 38 Component Replacement ccccccccceeeeseeeeeeeeceeeeeeeesseeeeeeeeeeeeeeeasseeeeseeeeeeaees 39 Power Supply Replacement AA 40 CO2 Manifold Replacement cccccseeeeeeeeeeeeeeceeeeeeeeeeeeeeeeeeeeaeaeeeeeeeeeeeeeeaaes 42 Control Board Replacement 2 snurrer Eee ELDELE 47 Control Board Installateur eege eege 48 Power Switch Replacement EE 49 CO2 Heater Switch Replacement TEE 50 Flow Control Assembly Replacement ccccccccecceeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeees 52 Ponts EIER ii e e a a a a a a ne ote a
39. that of a typical commercial or hospital environment Note 1 The EUT shuts off and must be manually restarted by the operator during a 5 second loss of AC Mains power 22 Table 4 Guidance And MANUFACTURER S Declaration Electromagnetic IMMUNITY For ME EQUIPMENT And ME SYSTEMS That Are Not LIFE SUPPORTING Guidance and manufacturer s declaration electromagnetic immunity he EGA 501 EGA 501E is intended for use in the electromagnetic environment specified below The customer or user of the EGA 501 EGA 501E should ensure that it is used in uch an environment Immunity Test EN IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Conducted RF EN IEC 61000 4 6 Radiated RF EN IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3 Vrms 3 V m 23 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 fixed 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 Table 6 Recommended Separation Distances Bet
40. the COz heater is turned on If not replace Control Board e Check copper tubing for any leaking or broken fittings from CO heater to output at front of unit If any fittings are broken replace the copper tubing assembly If there is a connection that is loose tighten the fitting and tighten to 90 inch pounds Water Bottle Warmer is not functioning e Replace the water bottle warmer 38 Component Replacement Water Bottle Warmer Heater Replacement Tools Required e 1 4 Nut driver or wrench e 1 16 hex wrench e 5 64 hex wrench e Phillips screwdriver Removal 1 Disconnect the unit from power wall outlet 2 Disconnect the Water Bottle Heater connection at the back of the EGA 501 3 Remove Water Bottle Warmer by removing the retaining screws 4 Refer to figure 1 Figure 1 4 Turn the Water Bottle Warmer over and remove the four retaining nuts and washers Remove retaining bracket Make note of orientation of defective heater It s important to apply replacement heater in the correct orientation See figure 2 Figure 2 39 7 Peel off defective heater 8 Remove old adhesive from the Water Bottle Warmer plate Installation 1 Remove paper backing from adhesive side of heater and attach to bottle heater plate making note to apply in the correct orientation 2 Attach retaining bracket and secure with the four retaining nuts and washers Connect the Water Bottle Warmer Assembly to the Tray
41. unction injury to the operator and or patient or costly damage to the unit and other equipment may occur The ENDO STRATUS CO Insufflator must be connected to an appropriate power source when loss of power source would result in an unacceptable risk Caution If emergency or abnormal function occurs immediately turn off the power to the unit Use only medical USP medical grade CO from a D or E size CO tank Read and understand all warnings that come with your commercially available D or E sized CO tanks Field servicing of the ENDO STRATUS CO Insufflator is limited to the replacement of the power cords water bottle holder and heater assemblies pump heads foot pedals and fuses Remove power from the device before initiating any field servicing of the replacement parts There are no user serviceable parts inside the ENDO STRATUS CO Insufflator unit Repairs to the ENDO STRATUS CO Insufflator should only be performed by qualified service personnel When the low pressure warning indicator illuminates exchange the CO tank as soon as possible to avoid loss of function Always keep a spare full tank of CO nearby for quick access Always keep the CO tank in an upright position to avoid fluid entering the unit Do not use the device if the enclosure is damaged or enclosure integrity has been compromised Do not attempt to operate the device before reading and understanding all sections of this manual
42. valuation 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 insufflation 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 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 Ab TI Refer To Operating Instructions Dangerous Voltage Equipotentiality DO NOT Allow Fingers to Contact Moving Parts Hot Surface MR Unsafe Warnings To reduce risk of electrical shock do not remove cover Refer servicing to qualified service personnel To avoid the risk of electric shock this equipment must only be connected to a supply mains with protective earth ground The ENDO STRATUS CO Insufflator is not suitable for use in the presence of a flammable anesthetic mixture with oxygen The ENDO STRATUS CO Insufflator shall be sold only by prescription for use
43. ween Portable And Mobile RF Communications Equipment And The EGA 501 EGA 501E EQUIPMENT and SYSTEMS That Are Not LIFE SUPPORTING Recommended Separations Distances for the EGA 501 EGA 501E 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 Max Output Separation m Separation m Separation m Power 150kHz to 80 to 800MHz 800MHz to 2 5GHz Watts 80MHz D 3 5 E1 Sqrt P D 7 E1 Sqrt P D 3 5 V1 Sqrt P 24 Cover Removal e Tools Required e 5 64 hex Wrench e Phillips Screwdriver Procedure 1 Disconnect power cord to the Insufflator 2 Disconnect the Water Warmer cable from the rear of the machine 3 Remove Water Bottle Warmer by removing the retaining screws 4 Refer to figure 1 4 Remove the screws 2 and Water Bottle Hanger Bracket from the left side of the unit Refer to figure 2 an Lift the Insufflator from the pump tray See figure 3 Remove the cover screws 1 each side See figure 4 Lift the Cover from the Insufflator Refer to figure 5 Figure 1 Figure 2 25 Figure 3 Figure 4 Figure 5 26 Insufflator
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