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EFFICIENT ENDOSCOPIC INSUFFLATOR Operator’s Manual

Page 9

SDO (if

applicable)

Symbol and

Reference

Number

Title of Symbol

Meaning of Symbol

5.4.4

Caution

Consult instructions for use for cautionary information.

IEC 60417

Graphical

Symbols for

Use on

Equipment

(ctd.)

5016

Fuse

To identify fuse boxes or their location

5021

Equipotentiality

Indicates the terminals which, when connected

together, bring various parts of the equipment/system

to the same potential.

5034

Input

To identify an input terminal

5035

Output

To identify an output terminal

5036

Dangerous Voltage

Indicates part(s) of the equipment which emit

dangerous voltages while energized.

5104

Start

To identify the start button

5110A

Stop

To identify the control or the indicator to stop the active

function

5140

Non-Ionizing Electromagnetic

Radiation

Indicates the equipment intentionally applies RF

electromagnetic energy for diagnosis or treatment.

5840

Type B applied part

Indicates a type B applied part complying with IEC

60601-1.

Содержание CO2EFFICIENT 710302

Страница 1: ...Endoscopic Insufflator REF 710302 Operator s Manual Rx Only US Patent 7 806 850 and US Patent 8 157 763 ...

Страница 2: ......

Страница 3: ...E HOSE AND YOKE ASSEMBLY 16 SECTION 9 0 ASSEMBLY PRIOR TO USE 17 9 1 PREPARATION 17 9 2 ELECTRICAL CONNECTIONS 17 9 3 CO2 HOSE CONNECTIONS 18 SECTION 10 0 SETTING UP FOR THE PROCEDURE 20 10 1 POWER ON AND GAS SUPPLY INDICATOR 20 10 2 PREPARATION TEST 20 10 3 TUBING SET CONNECTION 21 10 4 SETTING MODE OF OPERATION 21 10 5 RESET CO2 VOLUME 21 10 6 CONNECTION TO ENDOSCOPIC SYSTEM 21 10 7 SYSTEM SET U...

Страница 4: ...ing the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Examine the shipping carton and instrument for signs of damage Any breakage or other apparent damage should be noted the evidence retained and the carrier or shipping agency notified Verify that the shipping carton contains the items listed below CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Operator s Manual English Only Quick Reference Guide Foreign Language Ope...

Страница 5: ...of the gastrointestinal tract is necessary to support navigation of the endoscope and perform any evaluation procedures through the endoscope and should therefore not be used for any other treatments It should only be used under the direct guidance of a physician experienced in Gastrointestinal Endoscopy procedures This device is contraindicated for hysteroscopic or laparoscopic insufflation i e i...

Страница 6: ... the switch is set to Managed Flow Mode the system will be delivering CO2 in a more efficient manner This mode reduces the amount of CO2 that is lost through the air water valve which is normally lost at a rate of 3 liters per minute When gas is not used in the endoscopic system to insufflate the unit will operate at the Managed Flow rate of 0 25 to 1 0 liter per minute This transition to the Mana...

Страница 7: ...warranty STERIS Endoscopy cannot assume any risk related to the use of non STERIS Endoscopy brand product Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Never attempt to service the device when it is connected to a power source Hazardous voltages inside the device can cause severe electrical shock Disconnect the power cord befor...

Страница 8: ...sult in Serious Injury or Death This product contains phthalates which have been perceived as having possible carcinogenic mutagenic and reproductive risks However based on all existing scientific data the long history of safe use of medical device products containing phthalates as well as the short duration of contact with this device there are no known cancer or reproductive risks to humans Phys...

Страница 9: ...was manufactured 5 1 6 Catalog Number Indicates the manufacturer s catalogue number 5 1 7 Serial Number Indicates the manufacturer s serial number 5 2 8 Do not use if Package is Damaged Do not use if the product sterile barrier system or its packaging is compromised 5 3 7 Temperature Limitation Indicates the temperature limits to which the device can be safely exposed 5 3 8 Humidity Limitation Ind...

Страница 10: ...ng various parts of the equipment system to the same potential 5034 Input To identify an input terminal 5035 Output To identify an output terminal 5036 Dangerous Voltage Indicates part s of the equipment which emit dangerous voltages while energized 5104 Start To identify the start button 5110A Stop To identify the control or the indicator to stop the active function 5140 Non Ionizing Electromagne...

Страница 11: ...onic Equipment N A Waste Electrical and Electronic Equipment Do not dispose of electronic products in the general waste stream N A N A Unique Device Identifier Indicates the device unique device identifier N A N A Medical Device Indicates the product is a medical device N A N A Contents Indicates the number of devices kits within the packaging N A N A Warning for fuse type and rating Indicates fus...

Страница 12: ...5 mm Hg 0 10 A redundant relief of pressure at 400 mm Hg 0 24mmHg Both reliefs are active whether gas flow is on or off for added protection Operating modes Managed Flow Free Flow and FLOW STOP RUN Gas Inlet D or E CO2 supply tank WARNING Do not allow liquid CO2 to enter the unit This can be prevented by assuring that the CO2 supply tank is maintained in a vertical position at all times Gas Input ...

Страница 13: ...Relative Humidity 30 to 70 non condensing Operating Pressure 700 to 1060 hPascal 20 7 to 31 3 inches of Mercury Storage Temperature 32 to 160 F 0 to 70 C Storage Relative Humidity 20 to 90 non condensing Storage Pressure 500 to 1060 hPascal 14 8 to 31 3 inches of Mercury Not to be used in the presence of flammable gases NOTE This unit has not been tested for MR compatibility and should not be intr...

Страница 14: ... of the clinician and how this clinician uses CO2 to distend the gastrointestinal tract during a procedure In Managed Flow Mode the control system will automatically transition between the high flow rate and low flow rate as required during the procedure to compensate for external variables To prevent wasting gas in the Free Flow mode when the FLOW STOP RUN button is pressed initially and after 15...

Страница 15: ...us The clinician will use the air water valve on the endoscope and visual feedback of the endoscopic system to manually distend the gastrointestinal tract with CO2 When the switch is set to Managed Flow Mode the system will be delivering CO2 in an more efficient manner This mode reduces the amount of CO2 that is lost through the air water valve which is normally lost at a rate of 3 liters per minu...

Страница 16: ...e input device nominal AC line voltage 100 to 240 VAC frequency 50 60 Hz The AC line voltage should not drop below 90 VAC or exceed 264 VAC There are no switches or other AC line configuration requirements The line cord mains lead supplied with this unit is designed and approved for use in the USA and Canada only and should not be used outside these countries For use outside of the USA and Canada ...

Страница 17: ...URE HOSE AND YOKE ASSEMBLY The assembly consists of the YOKE as shown in Figure 8 1 and the HIGH PRESSURE HOSE as shown in Figure 8 2 NOTE Before proceeding to the next step check for the presence of the plastic gasket on the inside of the yoke arrow on Figure 8 1 Figure 8 2 Figure 8 1 ...

Страница 18: ...sed separately or on a flat surface away from potential sources of spraying or leaking liquids 2 Visually inspect the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR for external signs of damage 9 2 ELECTRICAL CONNECTIONS 1 Inspect the electrical connections Do not use if inspection reveals any damage 2 Connect the line cord mains lead to the AC Power Connection on the back of the CO2EFFICIENT ENDOSCOPIC INSU...

Страница 19: ...st valve and align the two positioning pins from the yoke with the two locating holes from the CO2 supply tank post valve Insert the pins into the locating holes and tighten the yoke on the post valve with the T handle provided with the yoke Place the valve wrench included with cart see Figure 9 3 or equivalent open ended wrench on the valve stem as shown in Figure 9 4 3 Remove cap from the CO2 In...

Страница 20: ...E D OR E supply tanks Before each use the following procedures or inspections should be performed Visually inspect the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR for external signs of damage Inspect the electrical connections Do not use if inspection reveals damage Before connecting the power cord to the wall outlet make sure the main power switch is off and that the voltage is correct Inspect the connec...

Страница 21: ...is functioning properly depress the FLOW STOP RUN button When pressed the light in the switch should light and gas may be heard exiting from the unit If gas does not begin flowing verify that the CO2 supply tank valve is in the open position see section 10 1 Power On and Gas Supply Indicator 3 To prevent wasting gas in the Free Flow mode when the FLOW STOP RUN button is pressed initially and after...

Страница 22: ...ng Set instructions for use 10 4 SETTING MODE OF OPERATION To set the mode of operation use the rocker switch on the front panel to select between Managed Flow and Free Flow 10 5 RESET CO2 VOLUME Assure that the Volume Liters Display reads zero prior to starting the procedure To reset the Volume Liters Display press the Volume Reset button NOTE Do not press Volume Reset button once procedure has s...

Страница 23: ...lowing operational sequence describes the system set up for both the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR and Tubing Set i Make sure the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR is powered up with no Tubing Set in place ii Make sure the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR is in STOP mode iii Use the Flow Mode Selection Switch to set the desired mode for the system iv As required zero the volume display ...

Страница 24: ... off the power to the insufflator and promptly disconnecting the Tubing Set at the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Output port 10 8 CO2 VOLUME DISPLAY The Digital Volume Display reads the total volume of CO2 passing from the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR to the patient The digital display indicates the volume of CO2 delivered in Liters and tenths of Liters and has a range of 0 to 999 Lit...

Страница 25: ...vered and stored in a cool dry location Care should be taken to avoid rough handling jarring or dropping the unit There are no user adjustments inside the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR case Repairs and adjustments are to be performed only by STERIS Endoscopy or authorized service or repair facilities Unauthorized service repair or modifications to the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR will...

Страница 26: ...tlet port on the front panel Switch unit to Free Flow mode using front panel rocker switch Open CO2 tank Confirm CO2 gas supply gauge on front panel illuminates fully When testing with the disposable water bottle tubing set place the capped end of the tubing set into a sterile water bottle that is 1 2 filled Place the free end the end that normally connects to the endoscope in a cup of sterile wat...

Страница 27: ... of CO2 Insufflation 5 Visual Inspection of Gas Outlet Connection 6 Inspection of Earth Leakage Current Actual Reading ___________________ If for any reason the integrity of the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR is suspect as a result of these inspection steps please call Customer Service to make arrangements for repair Tested By _________________________ Test Date ____________________ Unit Seri...

Страница 28: ...atching and marring of this device This warranty is in lieu of all other warranties expressed or implied including without limitation any implied warranty of merchantability or fitness for a particular use and of all other obligations or liabilities on the part of STERIS Endoscopy There are no warranties that extend beyond the description on the face hereof 11 4 CERTIFICATION OF NON CONTAMINATION ...

Страница 29: ...ior to disinfecting the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR ensure the power is turned off and the electrical cord is unplugged To disinfect the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR wipe down with an intermediate level disinfectant corrosive disinfectants such as bleach are not recommended since they may damage the equipment in accordance with the manufacturer s directions Do not use abrasive or sh...

Страница 30: ...to review the following information in this guide while simultaneously examining your unit Please be advised that the appearance of your CO2EFFICIENT ENDOSCOPIC INSUFFLATOR may differ slightly from the units shown in the following photographs Example buttons may be round or square The Field Checkout steps listed here pertain to common operating conditions and possible malfunctions Review this info...

Страница 31: ...up at all What should I do No power at wall outlet Blown fuse Check CO2EFFICIENT ENDOSCOPIC INSUFFLATOR in wall outlet known to be operational Remove power cord from rear panel of CO2EFFICIENT ENDOSCOPIC INSUFFLATOR and use a small screwdriver to open fuse holder Pull fuse holder down and examine fuses If blown replace with 0 5 Amp 250 Volt Time Delay Fuses ...

Страница 32: ...leting its Power up sequence the front panel should appear as follows The power switch should be illuminated with the VOLUME LITERS display will indicate 0 Additionally the GAS SUPPLY Indicator should also be illuminated and indicate the current amount of CO2 in the supply tank The above display indicates that the unit has correctly powered up Should the unit continue to fail to power up or if the...

Страница 33: ...the GAS SUPPLY Indicator should illuminate as follows 3 red 4 yellow and 3 green If during power up or operation of the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR the CO2 in the supply tank is depleted the illuminated GAS SUPPLY Indicator segments extinguish themselves from the full reading Once the GAS SUPPLY Indicator shows 3 red segments the unit will periodically beep and no longer deliver CO2 If thi...

Страница 34: ... making sure that your CO2EFFICIENT ENDOSCOPIC INSUFFLATOR is connected to the CO2 supply tank depress the VOLUME RESET button zero will appear in the VOLUME LITERS display Set the mode selector switch to FREE FLOW Disconnect the Tubing Set if connected Press the FLOW STOP RUN button to start Using a wrist watch with a second hand or a stop watch allow the unit to deliver 3 0 liters of CO2 The uni...

Страница 35: ... there is a high likelihood that the CO2 supply tank contents will gradually empty over several days If after opening and closing the CO2 supply tank valve with your procedure schedule you still encounter problems with CO2 supply tank prematurely emptying there is the possibility that the High Pressure Hose from the CO2 supply tank to the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR unit is leaking Please ...

Страница 36: ...ct After verifying all High Pressure Hose sealing surfaces are clean and free of defect reconnect the High Pressure Hose to the CO2 supply tank yoke and CO2EFFICIENT ENDOSCOPIC INSUFFLATOR Use an adjustable or opened ended wrench to tighten securely DO NOT USE ANY TEFLON TAPE OR THREAD SEALING COMPOUNDS Reconnect the yoke to the CO2 supply tank valve making sure that the plastic sealing disc is in...

Страница 37: ...the electromagnetic environment specified below The customer or the user of the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance CISPR 11 The unit 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 electroni...

Страница 38: ...spital environment Surge 5 KV 1 KV differential mode 5 KV 1 KV differential mode 5 KV 1 KV 2 KV common mode 5 KV 1 KV 2 KV common mode IEC 61000 4 11 Mains power quality should be that of a typical commercial or hospital environment If the user of the CO2EFFICIENT ENDOSCOPIC INSUFFLATOR requires continued operation during power mains interruptions it is recommended that the CO2EFFICIENT ENDOSCOPIC...

Страница 39: ...n meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagat...

Страница 40: ...wer of the communications equipment Separation distance according to frequency of transmitter Read maximum output power of transmitter M 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 7 GHz W d 1 2 P d 1 2 P d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance...

Страница 41: ...two years has elapsed between this date and product use the user should contact STERIS to determine if additional information is available Unless otherwise indicated all marks denoted with or are registered with the U S Patent and Trademark Office or are trademarks owned by STERIS Corporation Serious incidents that have occurred in relation to this medical device should be reported to the manufact...

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