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MPACT ENDOSCOPIC INSUFFLATOR

SYSTEM Operator’s Manual

Page 35

Section 14.0 EMC TABLES

The CO

MPACT ENDOSCOPIC INSUFFLATOR

SYSTEM has been tested by Underwriters

Laboratory to the following electro-magnetic compatibility standards:

Table 1

Guidance and

manufacturer’s declaration – electromagnetic emissions

The CO

MPACT ENDOSCOPIC INSUFFLATOR

SYSTEM is intended for use in the electromagnetic environment

specified below. The customer or the user of the CO

MPACT ENDOSCOPIC INSUFFLATOR

SYSTEM should

assure that it is used in such an environment.

Emissions Test

Compliance

Electromagnetic environment

– guidance

CISPR 11

Group 1

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 electronic
equipment.

RF Emissions

CISPR 11

Class A

RF Emissions

IEC 61000-3-2

Class A

Harmonic Emissions

IEC 61000-3-3

Voltage fluctuations /

Complies

flicker emissions

Содержание Co2mpact Endoscopic Insufflator

Страница 1: ...Rx Only REF 710300 Operator s Manual ...

Страница 2: ...IOR TO USE 14 8 1 PREPARATION 14 8 2 ELECTRICAL CONNECTIONS 14 8 3 CONNECTING TO A CO2 GAS CYLINDER 15 8 4 CONNECTING TO A CO2 GAS PIPELINE ADAPTER 16 SECTION 9 0 SETTING UP FOR THE PROCEDURE 17 9 1 POWER ON AND GAS SUPPLY INDICATOR 17 9 2 PREPARATION TEST 18 9 3 TUBING SET CONNECTION 18 9 4 CONNECTION TO ENDOSCOPIC SYSTEM 19 9 5 SYSTEM SET UP 20 9 6 TERMINATING GAS FLOW SHUT DOWN PROCEDURES 21 SE...

Страница 3: ...ATOR SYSTEM also referred to in this manual as unit or device or 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 CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM Line Cord see caution belo...

Страница 4: ...the endoscope and perform any evaluation procedures through the endoscope and should therefore not be used for any other treatments It should only be used under the direct guidance of a physician experienced in Gastrointestinal Endoscopy procedures This device is contraindicated for hysteroscopic or laparoscopic insufflation i e it must not be used for intrauterine distension This device is contra...

Страница 5: ...tem to manually distend the gastrointestinal tract with CO2 The unit operates in an identical manner to that of the air pump of an endoscopic system The user will need to place the system into START mode in order for it to deliver the CO2 to the endoscopic system This is done by powering ON the unit and then depressing the START STOP button on the front panel of the unit A green LED light adjacent...

Страница 6: ...rranty and US Endoscopy cannot assume any risk related to the use of non US Endoscopy products Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air oxygen or nitrous oxide Never attempt to service the device when it is connected to a power source Hazardous voltages inside the device can cause severe electrical shock Disconnect the power cord before servicing...

Страница 7: ...ied to the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM from commercially available CO2 supply tanks or from a wall source Please read and carefully follow all Warnings Cautions and Handling Instructions provided with and listed on the CO2 supply tank or wall source that is used with the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM Failure to do so can result in Serious Injury or Death This product contains p...

Страница 8: ...ord Electromagnetic interference or other interference may occur in this instrument when it is placed near other devices or RF communications equipment such as cellular phones If interference occurs mitigation measures may be necessary such as reorienting or relocating the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM or shielding the location Do Not attempt to use this system until you have completed al...

Страница 9: ...gerous voltage CO2 Gas Output to the patient Interconnection to ensure all equipment is at the same potential or earth ground This product should be recycled and not disposed of as general waste subject to WEEE annex IV resp EN 50419 In accordance with European Union WEEE Directive 2002 96 EC US Endoscopy will be fully responsible for the coordination logistics and costs of the WEEE process ...

Страница 10: ...f gas automatically stops Can be set to 30 Minutes 60 Minutes and 120 Minutes with an associated LED for each setting adjacent to the button All time functions have a tolerance of 10 Gas Supply Indicator Tri color LED that indicates how much gas is remaining in the USP medical grade gas cylinder Gas Flow 3 user selectable settings 2 0 1 8 2 3 liters minute Low 2 9 2 7 3 1 liters minute Medium 3 4 ...

Страница 11: ...Mains Power Cord IEC 320 compliant 5 3 UL EQUIPMENT CLASSIFICATION Underwriter s Laboratories CSA Class I Type B applied part IP31 Enclosure rating 5 4 ENVIRONMENTAL REQUIREMENTS Operating Temperature 50 to 104 F 10 to 40 C Operating Relative Humidity 30 to 70 non condensing Storage Temperature 32 to 160 F 0 to 70 C Storage Relative Humidity 30 to 75 non condensing Not to be used in the presence o...

Страница 12: ...g indicates a flow rate of 3 4 Liters Minute 3 FLOW TIMER Membrane type button that selects the amount of time that elapses before the flow of CO2 automatically stops An associated green LED will illuminate to indicate the time setting The three settings are 30 Minutes 60 Minutes and 120 Minutes NOTE The device will default to 60 Minutes when powered on 4 FLOW START STOP Membrane type button that ...

Страница 13: ...nection site 9 AC POWER CONNECTION Universal AC line 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 the...

Страница 14: ...t the mains power cord connector can easily be reached 3 The ideal mounting position is even with or above the height of the water bottle If the unit is mounted below the water bottle please use care not to allow water to siphon from the bottle back into the tubing set 4 Visually inspect the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM for external signs of damage 8 2 ELECTRICAL CONNECTIONS 1 Inspect th...

Страница 15: ... to a CO2 cylinder 3 Remove cap from the CO2 Input port on back of the unit Tighten the other end of the High Pressure Hose to the CO2 Input port on the back of the Unit using a 9 16 open ended wrench see Figure 8 1 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 upright position at all times USE ONLY MEDICAL ...

Страница 16: ...connector see Figure 8 3 on the CO2 Central Supply Hose to the CO2 gas pipeline hose and tighten the adapter manually until the position where the connector is stopped Figure 8 2 Figure 8 3 Before each use the following procedures or inspections should be performed Visually inspect the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM for external signs of damage Inspect the electrical connections Do not use...

Страница 17: ...Switch on the unit Upon turn on all lights and indicators will be illuminated for a brief period 2 The GAS SUPPLY INDICATOR LED illuminates red yellow or green The color coding is a guide to determine whether there is sufficient gas in a supply tank to finish a procedure as indicated below In Tank Mode LED Color Available CO2 Gas Green Tank Pressure is greater than 280 psi Yellow Tank Pressure is ...

Страница 18: ...minutes or 120 minutes The TIMER can be pre selected by the user depending on the anticipated length of the procedure After the pre selected time has elapsed the unit automatically returns to STOP mode Thereafter subsequent presses of the START STOP button will resume the delivery of CO2 for an additional 30 60 or 120 minutes depending on the pre selected time However the flow can be stopped at an...

Страница 19: ...n the Endoscope manufacturer there are different connections to the air water supply line Each connection has a Luer adaptor and some examples are provided below Figure 9 1 CO2 Adaptor for Pentax Endoscope Figure 9 2 Example Olympus Water bottle with CO2 Connection MAJ 902 PENTAX is the registered trademark of Hoya Corporation Olympus is the registered trademark of Olympus Corporation ...

Страница 20: ... Connect the Tubing Set fitting to CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM vi Select a flow rate of Low Medium or High using the FLOW button vii Select a shut off time of 30 60 or 120 Minutes using the TIMER button viii Start the endoscopic system by turning on the necessary light and video equipment ix Verify that the air supply from the endoscopic system is turned off x Start CO2MPACT ENDOSCOPIC ...

Страница 21: ... STOP button if in START mode 2 Discard the entire US Endoscopy Endoscopic Tubing Set daily according to standards and guidelines set forth by SGNA and APIC for reprocessing of water bottles used during Gastrointestinal Endoscopy 3 Turn power off and disconnect the power cord from power outlet 4 It is recommended that the CO2 cylinder valve be fully closed when not in use ...

Страница 22: ...nce they may damage the equipment in accordance with the manufacturer s directions Do not use abrasive or sharp edged devices when disinfecting the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM Do not spray fluids directly onto the unit or allow fluids to enter the unit Dry all components thoroughly Do not sterilize or autoclave this unit For general cleaning the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM ca...

Страница 23: ...ed that the following inspection be conducted on at least an annual basis and recorded on the following page Prior to recording a copy of the page should be made so that future inspection results can be recorded 1 Visually inspect the Mains or Power line cord that is used to provide power to your CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM If it is worn frayed or damaged replace it immediately with an ...

Страница 24: ... and start flow Monitor time lapse with a timer Approximately two minutes prior to each time expiration you will hear an audible tone double beep intended to alert the user In addition the selected timer setting 30 60 or 120 minutes will begin to flash If the flow is not depressed during the two minute warning time insufflation will stop and an audible tone double beep will be heard after the 30 6...

Страница 25: ...sufflation Pass Fail 4b L M H Flow settings Pass Fail 4c 30 60 120 Timer settings Pass Fail 5 Visual Inspection of Gas Outlet Connection Pass Fail 6 Inspection of Earth Leakage Current Pass Fail Actual Reading ___________________ If for any reason the integrity of the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM is suspect as a result of these inspection steps please call US Endoscopy Customer Services ...

Страница 26: ...cluding scratching 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 US Endoscopy There are no warranties that extend beyond the description on the face hereof 11 4CERTIFICATION OF NON CONTAMIN...

Страница 27: ...y kind Prior to disinfecting the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM ensure the power is turned off and the electrical cord is unplugged To disinfect the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM 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...

Страница 28: ... minutes to review the following information in this guide while simultaneously examining your unit Please be advised that the appearance of your CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM 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 Revi...

Страница 29: ...up at all What should I do No power at wall outlet Blown fuse Check CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM in wall outlet known to be operational Remove power cord from rear panel of CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM and use a small screwdriver to open fuse holder Pull fuse holder down and examine fuses If blown replace with 2 0 Amp 250 Volt Time Delay Fuses ...

Страница 30: ...p sequence the front panel should appear as follows The Gas Supply Indicator LED should be illuminated and indicate the current amount of CO2 in the supply tank The FLOW should be pre selected to High as indicated by a green LED The TIMER should be pre selected to 60 minutes as indicated by a green LED The above display indicates that the unit has correctly powered up Should the unit continue to f...

Страница 31: ...YSTEM should sense the pressure from the CO2 supply tank and the Gas Supply Indicator should illuminate as shown If during Power up or operation of the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM the CO2 in the supply tank is depleted the GAS SUPPLY INDICATOR LED will display red The unit will no longer deliver CO2 If this occurs reconnect the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM to a full CO2 supply...

Страница 32: ...e Gas OUTPUT You should feel CO2 exiting from the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM As a second test connect the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM to the endoscope system using a tubing set Power up the endoscope Be sure to turn off the endoscope air pump before turning on the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM After Powering up and making sure that your CO2MPACT ENDOSCOPIC INSUFFLAT...

Страница 33: ...s a high likelihood that the CO2 cylinder contents will gradually empty over several days If after opening and closing the CO2 cylinder valve with your procedure schedule you still encounter problems with the CO2 cylinder prematurely emptying there is the possibility that the High Pressure Hose from the CO2 cylinder to the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM unit is leaking Please inspect the H...

Страница 34: ...rifying all High Pressure Hose sealing surfaces are clean and free of defect reconnect the High Pressure Hose to the CO2 supply tank Yoke and CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM 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 cylinder valve making sure that the plastic sealing disk is in place Open...

Страница 35: ...in the electromagnetic environment specified below The customer or the user of the CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM should assure that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance CISPR 11 Group 1 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 ne...

Страница 36: ...ospital environment Surge 5 KV 1 KV differential 5 KV 1 KV differential mode 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 CO2MPACT ENDOSCOPIC INSUFFLATOR SYSTEM requires continued operation during power mains interruptions it is recommended that the CO2MPACT ENDOSCOPIC...

Страница 37: ...in 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 propaga...

Страница 38: ...tput power 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 d...

Страница 39: ...00732232 Rev B June 2018 ...

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