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Important Information — Please Read Before Use

9

UCR INSTRUCTION MANUAL

WARNING

• To prevent electrical shock hazards, the housing of the endoscopic CO

2

 regulation 

unit must be grounded. Always connect the power cord plug to a properly grounded 
hospital grade AC outlet (wall mains outlet).

Figure 1

• To ensure electrical safety, do not use this instrument with any of the following 

medical electrical equipment.

−

Medical electrical equipment that has not been approved for safe use in 
combination with this instrument.

−

Medical electrical equipment that has not been verified to be safe with respect to 
leakage current, etc.

• To ensure that the operation can be completed without complication in case of a 

malfunction, prepare a spare endoscopic CO

2

 regulation unit as a backup.

Power cord plug

Properly 
grounded wall 
mains outlet

Summary of Contents for UCR

Page 1: ...n Please Read Before Use 5 Chapter 1 Checking the Package Contents 13 Chapter 2 Instrument Nomenclature 17 Chapter 3 Installation and Connection 25 Chapter 4 Inspection 35 Chapter 5 Operation 45 Chapt...

Page 2: ......

Page 3: ...MAJ 1741 22 2 5 Optional components 23 Chapter 3 Installation and Connection 25 3 1 Installation workflow 25 3 2 Installation of the endoscopic CO2 regulation unit 26 3 3 Connecting a CO2 gas cylinder...

Page 4: ...g and water feeding 49 5 5 After use 50 Disconnecting the CO2 gas cylinder 50 Disconnecting the medical gas pipeline 51 Chapter 6 Reprocessing Storage Disposal and Transportation 53 6 1 Reprocessing 5...

Page 5: ...Contents iii UCR INSTRUCTION MANUAL Specifications 69 EMC information 73...

Page 6: ...iv Contents UCR INSTRUCTION MANUAL...

Page 7: ...t the locations shown below If the labels or symbols are missing or illegible contact Olympus UCR CO2 regulation unit Labels and Symbols UDI label The UDI label is required by some countries regulatio...

Page 8: ...anufacturer FUSES T2AH250V Timer Only the exclusive hose and adapter can be connected Only the exclusive cable can be connected CE marking MEDICAL DEVICE ENDOSCOPIC CO2 REGULATION UNIT MODEL OLYMPUS U...

Page 9: ...Labels and Symbols 3 UCR INSTRUCTION MANUAL Cylinder hose PIN MAJ 1080 Cylinder hose DIN MAJ 1081 Cylinder hose ISO MAJ 1082 Caution refer to instructions Caution refer to instructions...

Page 10: ...gas tube MAJ 1816 Gas tube ID indications on tags are shown as follows Back cover of this instruction manual HIGH MAJ 1741 MED MAJ 1742 LOW MAJ 1816 Symbol Description Manufacturer Authorized represen...

Page 11: ...y only when its potential benefits are greater than its risks Fully explain to the patient the potential benefits and risks of the endoscopy endoscopic treatment and endoscopic surgery as well as any...

Page 12: ...difficulty of endoscopy endoscopic treatment and endoscopic surgery This manual does not explain or discuss endoscopic procedures Instrument compatibility Refer to the System chart on page 67 to confi...

Page 13: ...affect the cardiac function of the patient Accordingly always adhere to the following points Never apply the endoscope connected to this endoscopic CO2 regulation unit to the heart or any area near t...

Page 14: ...s not explosion proof The concentration of oxygen is high Oxidizing agents such as nitrous oxide N2O are present in the atmosphere Flammable gases are present in the atmosphere Flammable liquids are n...

Page 15: ...rical safety do not use this instrument with any of the following medical electrical equipment Medical electrical equipment that has not been approved for safe use in combination with this instrument...

Page 16: ...art gas supply This will not only empty the CO2 gas cylinder but may also increase the CO2 concentration in the environment Use the endoscopic CO2 regulation unit only under the conditions described i...

Page 17: ...onment Use in combination with the upper lower gastrointestinal endoscope WARNING Over insufflating the lumen may cause patient pain injury bleeding gas embolism and or perforation Anytime you observe...

Page 18: ...insufflation warning light or alarm Although the insufflator is equipped with these functions it does not always prevent gas embolism inasmuch as this depends on the patient and the condition of the...

Page 19: ...s missing or you have any questions do not use the instrument immediately contact Olympus 1 1 Checking the package contents Endoscopic CO2 regulation unit UCR Endoscopic CO2 regulation unit UCR Access...

Page 20: ...Olympus items are optional items which may also be purchased separately Cylinder hose for UHI 3 PIN MAJ 1080 Cylinder hose for UHI 3 DIN MAJ 1081 Cylinder hose for UHI 3 ISO MAJ 1082 Medical gas pipe...

Page 21: ...uld be returned to Olympus directly after installation Low flow gas tube MAJ 1742 Extra low flow gas tube MAJ 1816 Low flow gas tube MAJ 1742 Extra low flow gas tube MAJ 1816 Cylinder hose for UHI 3 P...

Page 22: ...rench should be returned to Olympus directly after installation Cylinder hose for UHI 3 DIN MAJ 1081 Cylinder hose for UHI 3 ISO MAJ 1082 1 1 The endoscopic CO2 regulation unit is compatible with the...

Page 23: ...panel 2 1 Symbols and descriptions Symbol Description Symbol Description Power ON OFF Gas source pressure Start CO2 gas outlet Stop Type BF applied part Symbol Description Symbol Description CO2 gas i...

Page 24: ...18 2 2 Front panel UCR INSTRUCTION MANUAL Ch 2 2 2 Front panel 3 1 2 4 5 6 7...

Page 25: ...top green LED is illuminated 4 Start stop switch Press the start stop switch in the Stop mode to light up the start indicator and start the gas supply Pressing the switch during gas supply extinguishe...

Page 26: ...20 2 3 Rear panel UCR INSTRUCTION MANUAL Ch 2 2 3 Rear panel 1 2 3 4 5 6...

Page 27: ...Potential equalization terminal In case of equipotential connect this terminal to a potential equalization busbar of the electrical installation 4 AC power inlet Connect the power cord here 5 CO2 gas...

Page 28: ...Ch 2 2 4 Gas tube MAJ 1741 No Nomenclature Description 1 Instrument side connector Connect to the CO2 gas outlet on the front panel of the endoscopic CO2 regulation unit 2 Tube 3 Water container side...

Page 29: ...the gas cylinder and cylinder hose 3 Pin Insert to the guide hole of the adapter of the CO2 gas cylinder 4 Hose 5 Connector Use the supplied wrench to connect this connector to the CO2 gas inlet on t...

Page 30: ...ption 1 Connector Connect the medical gas pipeline hose here 2 Connector Use the supplied wrench to connect this connector to the CO2 gas inlet on the rear panel of the endoscopic CO2 regulation unit...

Page 31: ...rument See the installation workflow in Figure 3 1 below Follow each step of the workflow before using the endoscopic CO2 regulation unit 3 1 Installation workflow 1 Install the instrument Section 3 2...

Page 32: ...ions etc In addition oil impurities etc may penetrate the interior of the endoscopic CO2 regulation unit and impede proper CO2 gas insufflation CAUTION If the cylinder hose is damaged replace it with...

Page 33: ...egulation unit by Olympus personnel during installation The enclosed nut cover will be fixed during the installation when the cylinder hose and the endoscopic CO2 regulation unit are connected by Olym...

Page 34: ...e of about 17 2 N m 1 8 kgf m Figure 3 2 5 When using the cylinder hose MAJ 1081 MAJ 1082 use the supplied wrench to attach the cylinder hose s adapter to a gas cylinder filled with CO2 gas Figure 3 3...

Page 35: ...00 kPa Use MAJ 1084 for NIST type fittings and MAJ 1085 for DISS type fittings Do not use any other hoses than those specified NOTE Olympus does not sell medical gas pipeline hoses Use an appropriate...

Page 36: ...ument is connected has adequate electrical capacity that is larger than the total power consumption of all connected equipment If the capacity is insufficient fire can result or a circuit breaker may...

Page 37: ...unit and electrosurgical unit Otherwise malfunction of the equipment may result 1 Confirm that the endoscopic CO2 regulation unit is OFF 2 Connect the power cord of the endoscopic CO2 regulation unit...

Page 38: ...enous sets a trocar veress needle etc Always use the provided gas tube MAJ 1741 MAJ 1742 MAJ 1816 Non Olympus tubes may impair the performance and lead to incorrect operation Never attempt to alter th...

Page 39: ...Connect the instrument side connector end of the gas tube to the CO2 gas outlet of the endoscopic CO2 regulation unit by turning it clockwise Figure 3 7 2 Connect the other connector of the gas tube...

Page 40: ...water container and endoscope UCR INSTRUCTION MANUAL Ch 3 Connect the equipment such as the water container MAJ 902 and endoscope as described in their instruction manuals 3 7 Connecting the water co...

Page 41: ...Chapter 7 Troubleshooting If the irregularity is still observed after consulting Chapter 7 contact Olympus Damage or irregularity may compromise patient or user safety and may result in more severe eq...

Page 42: ...gas tube is not used so it therefore does not need inspection 2 Confirm that the endoscopic CO2 regulation unit turns ON normally on page 38 3 Confirm that a gas cylinder or the medical gas pipeline a...

Page 43: ...procedure for packing O ring which is included with the cylinder hose for UHI 3 MAJ 1080 WARNING If the medical gas pipeline adapter is damaged replace it with a new one Inspect the packing inside the...

Page 44: ...ew one Inspection of the power supply CAUTION If the power indicator does not light up the instrument may be damaged Immediately turn the endoscopic CO2 regulation unit OFF disconnect the power plug f...

Page 45: ...irm that the supply pressure remains unchanged CAUTION The gas pressure display displays not the remaining amount of the CO2 gas but the supply pressure Always have a CO2 gas cylinder available in cas...

Page 46: ...e medical gas pipeline system to confirm that the supply pressure is at the specified level 3 Press the start stop switch to stop the gas supply 1 Disconnect the gas tube from the CO2 gas outlet of th...

Page 47: ...supplied the gas tube may be clogged Replace the gas tube with a new one 5 Cover the port on the water container side connector of the gas tube with a clean fingertip and confirm that the gas flow in...

Page 48: ...3 1 Confirm that the light source stops supplying air 2 Press the start stop switch to start gas supply 3 Immerse the distal end of the connected endoscope in sterile water and operate the endoscope s...

Page 49: ...f the power indicator remains lit after this instrument has been turned OFF do not use this instrument unplug the power cord from the power outlet and contact Olympus 1 Press the power switch to turn...

Page 50: ...44 4 6 Inspection of the endoscopic CO2 regulation unit UCR INSTRUCTION MANUAL Ch 4...

Page 51: ...endoscope s air water valve Persons in the operating room may be affected if the CO2 concentration in the operating room increases Be sure to ensure ventilation of the room If an irregularity is obser...

Page 52: ...r 4 on page 35 3 Turn the endoscopic CO2 regulation unit ON on page 47 4 Select the gas supply source on page 47 5 Select the timer setting on page 48 6 Operate the endoscopic CO2 regulation unit 1 Se...

Page 53: ...selection switch on the rear panel to the Cylinder mode See Figure 5 1 2 The gas pressure display shows the gas supply pressure of the CO2 cylinder If the supply pressure drops below the minimum requi...

Page 54: ...ally stop feeding gas as the set time elapses NOTE See below the available timer settings Select OFF to negate the automatic gas function Table 5 1 Slide the timer switch to select the timer setting F...

Page 55: ...CO2 regulation unit is combined with the Gas tube MAJ 1741 the Low flow gas tube MAJ 1742 or Extra low flow gas tube MAJ 1816 the gas flow rate is approximately equivalent to that when the airflow pre...

Page 56: ...and may cause difficulty in breathing if inhaled Disconnecting the CO2 gas cylinder 5 5 After use 1 Close the gas cylinder valve by turning it clockwise Figure 5 4 2 Disconnect the water container si...

Page 57: ...iner MAJ 902 3 Disconnect the Gas tube MAJ 1741 Low flow gas tube MAJ 1742 or Extra low flow gas tube MAJ 1816 from the CO2 gas outlet of this instrument 4 Press the start stop switch of the endoscopi...

Page 58: ...52 5 5 After use UCR INSTRUCTION MANUAL Ch 5...

Page 59: ...CO2 regulation unit and accessories below This section is based on the requirements of ISO 17664 NOTE Reprocess the water container MAJ 902 as described in the instruction manual for the water contain...

Page 60: ...es Medical agents may enter the endoscopic CO2 regulation unit and accessories through the ventilation grills and or the gaps and may cause a fire and or equipment damage Use a surface disinfectant cl...

Page 61: ...regulation unit and accessories These methods will damage them Do not wipe the external surface with hard or abrasive wiping material The surface will be scratched When patient debris enters a hole o...

Page 62: ...er s instructions regarding concentration drying temperature contact time use life and expiration date The surface disinfectant cleaner shown in Table 6 2 was used for validation Table 6 2 Surface dis...

Page 63: ...e signs of deterioration or notice any other evidence of deterioration contact Olympus Crack appears on the panel or the Power switch Discoloration on the panel or the top cover Peeling of the labels...

Page 64: ...al resistant gloves 1 1 Long sleeve gloves are recommended to prevent skin exposure Chemicals used for reprocessing Surface disinfectant cleaner Refer to Section 6 2 Surface disinfectant cleaner on pa...

Page 65: ...on unit and accessories 2 If patient debris directly or indirectly adheres to this instrument and accessories refer to Disinfection on page 60 Otherwise be sure to follow the next step 3 If disinfecti...

Page 66: ...urer Failure to do so may adversely affect the human body or this instrument After wiping with a moistened lint free cloth dry the endoscopic CO2 regulation unit and accessories thoroughly before usin...

Page 67: ...moistened lint free cloth 6 Ensure that the surfaces are completely wet for the contact time instructed by the surface disinfectant cleaner manufacturer 7 If any surface of the endoscopic CO2 regulat...

Page 68: ...xposed to direct sunlight X rays radio activity or strong electromagnetic radiation e g near microwave medical treatment equipment short wave medical treatment equipment MRI radio equipment or cellula...

Page 69: ...endoscopic CO2 regulation unit or any of its components such as fuses be sure to observe your national and local laws and guidelines When transporting the endoscopic CO2 regulation unit and accessorie...

Page 70: ...64 6 8 Transportation UCR INSTRUCTION MANUAL Ch 6...

Page 71: ...power switch is not set to ON Set the power switch to ON The indicators on the front panel do not light The power cord plug is not connected Connect the power cord plug The power switch is not set to...

Page 72: ...alve of the CO2 gas cylinder is closed Open the valve The CO2 cylinder is running out of gas Replace the cylinder with a new one The cylinder hose or the medical gas pipeline adapter is not connected...

Page 73: ...If combinations of equipment other than those shown below are used the full responsibility should be assumed by the medical treatment facility Such combinations do not only not allow the equipment to...

Page 74: ...er container MAJ 902 Endoscopic CO2 regulation unit UCR LC S190 10 F LC S190 10 0 LC S190 10 30 Lens cleaning sheath Cylinder hose DIN MAJ 1081 ISO MAJ 1082 150 series EVIS 140 series EVIS EXERA 145 1...

Page 75: ...n Within 10 Frequency 50 60 Hz Frequency fluctuation Within 1 Hz Input 40 VA Fuse rating 2 A 250 V Fuse size 5 20 mm Size Dimensions 130 W 156 H 334 D mm housing dimensions Weight 4 9 kg Applicable ga...

Page 76: ...n power cord Degree of protection against electrical shock of applied part Type BF applied part Gas tube MAJ 1741 Low flow gas tube MAJ 1742 Extra low flow gas tube MAJ 1816 EMC Applied standard IEC 6...

Page 77: ...for return and or collection systems available in your country UDI label Indication The UDI label is required by some countries regulations regarding the identification of a medical device also known...

Page 78: ...e length 1000 mm Tube external diameter 9 mm Flow rate Using this tube the gas flow rate is approximately equivalent to the airflow pressure level High of the light source Item Specification Tube leng...

Page 79: ...for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Radiated emissions CISPR 11 Class B This instrument s RF e...

Page 80: ...EC 61000 4 2 Contact 8 kV Air 2 4 8 15 kV Contact 2 4 6 kV Air 2 4 8 kV Same as left Floors should be made of wood concrete or ceramic tile that hardly produces static If floors are covered with synth...

Page 81: ...battery 40 UT 60 dip in UT for 5 cycle 70 UT 30 dip in UT for 25 cycle 50 Hz 30 cycle 60 Hz Phase angle causing voltage dips 0 70 UT 30 dip in UT for 25 cycle 0 UT 100 dip in UT for 250 cycle 50 Hz 30...

Page 82: ...separation distance Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m 6V ISM b...

Page 83: ...and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measu...

Page 84: ...pment could result Test frequency MHz Band MHz Modulation 1 1 The carrier shall be modulated using a 50 duty cycle square wave signal Maximum power W Immunity test level V m 385 380 390 Pulse modulati...

Page 85: ...reproduced or distributed without the express written permission of OLYMPUS MEDICAL SYSTEMS CORP OLYMPUS is a registered trademark of OLYMPUS CORPORATION Trademarks product names logos or trade names...

Page 86: ...United Kingdom Fax 01702 465677 Telephone 01702 616333 438B Alexandra Road 03 07 12 Alexandra Technopark Blk B Singapore 119968 Fax 6834 2438 Telephone 6834 0010 A8F Ping An International Financial C...

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