Instructions
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INSTRUCTIONS
ENDOSCOPIC CO2 REGULATION UNIT
OLYMPUS UCR
Contents
Contents Labels and Symbols ...
1
Important Information - Please Read Before Use...
5
Intended use ...
5
Applicability of endoscopy and endoscopic treatment ...
5
Instruction manual ...
5
User qualifications...
6
Instrument compatibility ...
6
Repair and modification ...
6
Signal words...
7
Dangers and warnings and cautions ...
7
Chapter 1
Checking the Package Contents...
13
Optional items ...
14
Instrument Nomenclature ...
18
2.1
Symbols and descriptions ...
18
2.2
Front panel...
19
2.3
Rear panel ...
21
2.4
Gas tube (MAJ-1741)...
23
2.5
Optional components ...
23
Installation and Connection ...
26
3.1
Installation work flow...
26
3.2
Installation of the endoscopic CO2 regulation unit ...
27
3.3
Connecting a CO2 gas cylinder...
28
3.4
Connecting the medical gas pipeline adapter (MAJ-1084, MAJ-1085) 31
3.5
Connecting to an AC power supply...
3.6
Connecting the gas tube (MAJ-1741), low flow gas tube (MAJ-1742),
1.1
Chapter 2
Chapter 3
3.7
33
and extra low flow gas tube (MAJ-1816)...
35
Connecting the water container and endoscope...
36
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Contents
Chapter 4
Inspection...
37
4.1
Inspection work flow...
38
4.2
Inspection of the cylinder hose (MAJ-1080, MAJ-1081, MAJ-1082)
39
4.3
Inspection of the medical gas pipeline adapter (MAJ-1084, MAJ-1085)39
4.4
Inspection of the gas tube (MAJ-1741), low flow gas tube (MAJ-1742), and extra low flow gas tube (MAJ-1816)...
40
Inspection of the endoscopic CO2 regulation unit ...
40
Operation...
46
5.1
Operation flow ...
47
5.2
Gas supplying and water feeding...
50
5.3
After use...
51
Care, Storage, and Disposal ...
53
6.1
General policy ...
53
6.2
Precautions ...
54
6.3
Compatible reprocessing methods and chemical agents...
55
6.4
Cleaning CO2 regulation unit, cylinder hose and gas pipeline adapter 60
6.5
Storing CO2 regulation unit, cylinder hose and gas pipeline adapter
6.6
Cleaning the gas tube (MAJ-1741), low flow gas tube (MAJ-1742),
4.5
Chapter 5
Chapter 6
and extra low flow gas tube (MAJ-1816)... 6.7
6.9
62
Disinfecting the gas tube (MAJ-1741), low flow gas tube (MAJ-1742), and extra low flow gas tube (MAJ-1816)...
6.8
61
63
Rinsing the gas tube (MAJ-1741), low flow gas tube (MAJ-1742), and extra low flow gas tube (MAJ-1816)...
63
Sterilization ...
65
6.10 Storing the gas tube (MAJ-1741), low flow gas tube (MAJ-1742), and extra low flow gas tube (MAJ-1816)...
67
6.11 Care and storage of the water container (MAJ-902) ...
67
6.12 Disposal ...
67
Chapter 7
ii
Troubleshooting ...
68
7.1
Troubleshooting guide ...
68
7.2
Returning the endoscopic CO2 regulation unit for repair ...
69
Appendix...
70
System chart ...
70
Specifications ...
72
EMC information...
77
ENDOSCOPIC CO2 REGULATION UNIT UCR
Labels and Symbols
Labels and Symbols Safety-related labels and symbols are attached to the instrument at the locations shown below. If the labels or symbols are missing or illegible, contact Olympus.
UCR CO2 regulation unit
Timer
Crossed-out wheeled bin’ symbol
Caution that only the exclusive cable can be connected. CE marking
Potential equalization terminal
Electrical rating plate Product name, rated voltage and frequency are shown. ENDOSCOPIC CO2 REGULATION UNIT MODEL: OLYMPUS UCR INPUT: 100 – 240V 50/60Hz 40VA SN
Serial number plate
Fuse rating FUSES T2AH250V
CO2 gas inlet Manufacturer name
Caution that only the exclusive hose and adapter can be connected.
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Labels and Symbols
Cylinder hose (PIN, MAJ-1080)
Caution, refer to instructions.
Cylinder hose (DIN, MAJ-1081) Cylinder hose (ISO, MAJ-1082)
Caution, refer to instructions.
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ENDOSCOPIC CO2 REGULATION UNIT UCR
Labels and Symbols
Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), Extra low flow gas tube (MAJ-1816)
Caution, refer to instructions.
Gas tube ID indications on tags are shown. “HIGH”
(MAJ-1741)
“MED”
(MAJ-1742)
“LOW”
(MAJ-1816)
Back cover of this instruction manual
Manufacturer
Authorized representative in the European Community
ENDOSCOPIC CO2 REGULATION UNIT UCR
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Labels and Symbols
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ENDOSCOPIC CO2 REGULATION UNIT UCR
Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended use The endoscopic CO2 regulation unit has been designed to be used with Olympus gastrointestinal endoscopes and ancillary equipment for CO2 gas and water feeding. Do not use the endoscopic CO2 regulation unit for any purpose other than its intended use.
Applicability of endoscopy and endoscopic treatment If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the hospital’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risks (their natures, extent and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient. Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.
Instruction manual This instruction manual contains essential information on using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment that will be used during the procedure and use the instruments as instructed. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.
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Important Information - Please Read Before Use
User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. If there is no official qualification standard, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures.
Instrument compatibility Refer to the “System chart” in the Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage. This instrument complies with the EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connecting to an instrument that complies with the EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.
Repair and modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify, or attempt to repair it; patient or user injury and/or equipment damage can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 7, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 7, contact Olympus.
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Important Information - Please Read Before Use
Signal words The following signal words are used throughout this manual:
Indicates an imminently hazardous situation that, if not avoided, will result in death or serious injury.
Indicates a potentially hazardous situation that, if not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation that, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.
Indicates additional helpful information.
Dangers and warnings and cautions Follow the dangers and warnings given below when handling this instrument. This information is to be supplemented by the dangers and warnings given in each chapter.
•
As a TYPE BF applied part, this endoscopic CO2 regulation unit must never be applied directly to the heart and must not be used in procedures involving cardiac observation or surgery. Leakage current from the TYPE BF applied part may be dangerous and cause ventricular fibrillation or otherwise seriously 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 the heart. Never allow an endo-therapy accessory or another endoscope applied to or near the heart to come in contact with an endoscope connected to this endoscpoic CO2 regulation unit.
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Important Information - Please Read Before Use
•
Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of an electric shock. When the endoscopic CO2 regulation unit is used to examine a patient, do not allow metal parts of the endoscope or its accessories to touch metal parts of other system components. Such contact may cause unintended current flow to the patient. Keep fluids away from all electrical equipment. If fluids are spilled on or into the endoscopic CO2 regulation unit, stop operation of the unit immediately and contact Olympus. Do not prepare, inspect or use this CO2 regulation unit with wet hands.
•
Never install and operate the endoscopic CO2 regulation unit in locations where: 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 near. Otherwise, explosion or fire may result because the endoscopic CO2 regulation unit is not explosion-proof.
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•
Supply medical grade CO2 gas only. Never use other kinds of gas. Using gases other than CO2 gas may result in fire, poisoning, complications, etc.
•
Use the endoscopic CO2 regulation unit only for the upper/lower digestive tract.
•
To prevent electrical shock hazards, the housing of the endoscopic CO2 regulation unit must be grounded. Always connect the power cord plug to a properly grounded hospital grade AC outlet (wall mains outlet).
ENDOSCOPIC CO2 REGULATION UNIT UCR
Important Information - Please Read Before Use
Properly grounded wall mains outlet
Power cord plug
•
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 CO2 regulation unit as a backup.
•
Anytime you suspect an abnormality in the endoscopic CO2 regulation unit, immediately stop using the endoscopic CO2 regulation unit and withdraw the endoscope from the patient slowly as described in the endoscope’s instruction manual.
•
Occurrences of hypercapnemia through CO2 absorption have been reported in medical literature, primarily during laparoscopic surgery. Careful clinical review prior to the procedure should be undertaken by trained medical personnel to eliminate this potential risk. To avoid complications, monitor patient parameters such as PCO2, electrocardiogram, body temperature, etc., while using the endoscopic CO2 regulation unit. – Reference 1) Norman J, Atkinson SA: The effect of cardiac sympathetic blockade on the relationship between cardiac output and carbon dioxide tension in the anesthetized dog. Br J Anaesth 42: 592 – 602, 1970 2) Scott, D. B. and Julian, D. G.: Observations on cardiac arrhythmias during laparoscopy. Br. Med. J.,1: 411 – 413, 1972.
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Important Information - Please Read Before Use
3) Smith, I., Benzie, R. J., Gordon, N. L. M., et al.: Cardiovascular effects of peritoneal insufflation of carbon dioxide for laparoscopy. Br. Med. J., 3: 410 – 411, 1971. 4) Lenz, R. J., Thomas, T. A. and Wilkins, D. G.: Cardiovascular changes during laparoscopy: Studies of stroke volume and cardiac output using impedance cardiography. Anaesthesia, 31: 4 – 12, 1976. 5) Ishizaki, Y., Bandai, Y., Shimomura, K., et al.: Safe intra-abdominal pressure of carbon dioxide pneumoperitoneum during laparoscopic surgery. Surgery, 114: 549 – 554, 1993.
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•
The endoscopic CO2 regulation unit has no function of intraluminal pressure measurement and automatic control.
•
Over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism and/or perforation.
•
During use, always stop the light source device from supplying air. If “Stop” is not selected, a mixture of air and CO2 may be supplied into the patient body.
•
The CO2 gas is normally emitted through the small hole in the 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.
•
Always use the provided power cord with the endoscopic CO2 regulation unit. Using another power cord may result in equipment failure or power cord burns. The provided power cord has been designed exclusively for the endoscopic CO2 regulation unit and should not be used with other equipment.
•
Be sure to turn the endoscopic CO2 regulation unit OFF after use. If it is left ON after examination, an accidental contact with the start/stop switch may start gas supply. This will not only empty the CO2 gas cylinder but may also increase the CO2 concentration in the environment.
•
Only use the endoscopic CO2 regulation unit under the conditions described in “Operation environment” in the Appendix. Use under other conditions may not only impair the normal performance, but may also result in equipment damage.
•
Prepare spare CO2 gas cylinders for quick replacement if the cylinder used during the procedure should run out.
ENDOSCOPIC CO2 REGULATION UNIT UCR
Important Information - Please Read Before Use
•
To prevent the water in the water feed tank from flowing into this unit through the gas tube, install this unit in a position as high as possible compared to the water feed tank.
•
Do not use a pointed or hard object to press the buttons on the front panel. This may damage the instrument.
•
To prevent equipment damage, do not use it in a dusty environment.
•
Electromagnetic interference may occur to this instrument when it is placed near equipment marked with the following symbol or other portable and mobile RF communications equipment such as cellular phones. If radio interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument or shielding the location.
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Important Information - Please Read Before Use
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ENDOSCOPIC CO2 REGULATION UNIT UCR
Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus.
Power cord
Endoscopic CO2 regulation unit (UCR)
Water container (MAJ-902)
Gas tube (MAJ-1741)
Nut cover Instruction manual
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Chapter 1 Checking the Package Contents
1.1
Optional items The following Olympus items are optional items which may be purchased separately according to the examination technique and/or patient condition. •
Low flow gas tube (MAJ-1742)
•
Extra low flow gas tube (MAJ-1816)
The following 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 pipeline adapter for UHI-3 (NIST, MAJ-1084)
•
Medical gas pipeline adapter for UHI-3 (DISS, MAJ-1085)
The following non-Olympus item may also be purchased separately. •
Medical gas pipeline hose
For other equipment combinations, refer to the “Sysrem chart” in the Appendix.
Low flow gas tube (MAJ-1742) Extra low flow gas tube (MAJ-1816)
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ENDOSCOPIC CO2 REGULATION UNIT UCR
Chapter 1 Checking the Package Contents
Cylinder hose for UHI-3 (PIN, MAJ-1080)
Cap
Wrench
Hose for cylinder
The endoscopic CO2 regulation unit is compatible with the cylinder hose for UHI-3 (MAJ-1080).
The wrench is supplied for installation of the unit by an Olympus sales representative or service engineer only. The wrench should be returned to Olympus directly after installation.
Cylinder hose for UHI-3 (DIN, MAJ-1081) Cylinder hose for UHI-3 (ISO, MAJ-1082)
Cap1
Cap2
Wrench (large)
Hose for cylinder Wrench (small) The endoscopic CO2 regulation unit is compatible with the cylinder hose for UHI-3 (MAJ-1081, MAJ-1082).
The wrench (small) is supplied for installation of the unit by an Olympus sales representative or service engineer only. The wrench (small) should be returned to Olympus directly after installation.
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Chapter 1 Checking the Package Contents
Medical gas pipeline adapter for UHI-3 (NIST, MAJ-1084) Medical gas pipeline adapter for UHI-3 (DISS, MAJ-1085)
Adapter for medical gas pipeline
Wrench
The endoscopic CO2 regulation unit is compatible with the medical gas pipeline adapter (MAJ-1084, MAJ-1085).
The wrench is supplied for installation of the unit by an Olympus sales representative or service engineer only. The wrench should be returned to Olympus directly after installation.
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Chapter 1 Checking the Package Contents
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