Olympus UCR User manual

INSTRUCTIONS
ENDOSCOPIC CO2REGULATION UNIT
OLYMPUS UCR
Labels and Symbols 1
Important Information — 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
Chapter 6 Reprocessing, Storage,
Disposal, and Transportation 53
Chapter 7 Troubleshooting 65
Appendix 67

Contents
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UCR INSTRUCTION MANUAL
Contents
Labels and Symbols .......................................................................................................... 1
Important Information — Please Read Before Use ......................................................... 5
Intended use .......................................................................................................................... 5
Applicability of endoscopy, endoscopic treatment, and endoscopic surgery ......................... 5
Instruction manual ................................................................................................................. 5
User qualifications ................................................................................................................. 6
Instrument compatibility ......................................................................................................... 6
Repair and modification ......................................................................................................... 6
Signal words .......................................................................................................................... 7
Dangers, warnings, and cautions .......................................................................................... 7
Chapter 1 Checking the Package Contents ....................................... 13
1.1 Checking the package contents ........................................................................... 13
1.2 Optional items ........................................................................................................ 14
Chapter 2 Instrument Nomenclature .................................................. 17
2.1 Symbols and descriptions ..................................................................................... 17
2.2 Front panel .............................................................................................................. 18
2.3 Rear panel ............................................................................................................... 20
2.4 Gas tube (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 ............................................................................ 26
3.4 Connecting the medical gas pipeline adapter (MAJ-1084, MAJ-1085) .............. 29
3.5 Connecting to an AC power supply ...................................................................... 30
3.6 Connecting the Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), and Extra
low flow gas tube (MAJ-1816) 32
3.7 Connecting the water container and endoscope ................................................ 34
Chapter 4 Inspection ............................................................................ 35
4.1 Inspection before use ............................................................................................ 35
4.2 Inspection workflow ............................................................................................... 36
4.3 Inspection of the cylinder hose (MAJ-1080, MAJ-1081, MAJ-1082) ................... 37
4.4 Inspection of the medical gas pipeline adapter (MAJ-1084, MAJ-1085) ............ 37
4.5 Inspection of the Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742), and Extra

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UCR INSTRUCTION MANUAL
low flow gas tube (MAJ-1816) 38
4.6 Inspection of the endoscopic CO2 regulation unit .............................................. 38
Inspection of the power supply ............................................................................................ 38
Inspection of the gas supply ................................................................................................ 39
Inspection of insufflation ...................................................................................................... 40
Inspection of gas feeding at gas tube .................................................................................. 41
Inspection of gas and water feeding .................................................................................... 42
Power OFF .......................................................................................................................... 43
Chapter 5 Operation ............................................................................. 45
5.1 Precaution for operation ........................................................................................ 45
5.2 Operation flow ........................................................................................................ 46
5.3 Function setting before use .................................................................................. 47
Turn the endoscopic CO2 regulation unit ON ...................................................................... 47
Selecting the gas supply source .......................................................................................... 47
Timer setting ........................................................................................................................ 48
5.4 Gas supplying 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 .......................................................................................................... 53
6.2 Surface disinfectant cleaner .................................................................................. 56
6.3 Signs of degradation from reprocessing ............................................................. 57
6.4 Preparing equipment for reprocessing ................................................................ 58
Equipment needed .............................................................................................................. 58
6.5 Reprocessing the endoscopic CO2 regulation unit and accessories ............... 59
6.6 Storage .................................................................................................................... 62
6.7 Disposal ................................................................................................................... 63
6.8 Transportation ........................................................................................................ 63
Chapter 7 Troubleshooting .................................................................. 65
7.1 Troubleshooting guide ........................................................................................... 65
Endoscopic CO2 regulation unit (UCR) ............................................................................... 65
7.2 Returning the endoscopic CO2 regulation unit for repair .................................. 66
Appendix ................................................................................................. 67
Combination equipment .................................................................................................. 67
System chart ........................................................................................................................ 67
Transportation, storage, and operating environments ................................................ 69

Contents
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UCR INSTRUCTION MANUAL
Specifications .................................................................................................................. 69
EMC information .............................................................................................................. 73

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UCR INSTRUCTION MANUAL

Labels and Symbols
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UCR INSTRUCTION MANUAL
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 CO2regulation unit
Labels and Symbols
UDI label
The UDI label is required by some countries’ regulations
regarding the identification of a medical device also known
as Unique Device Identification (UDI).
Front panel

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Labels and Symbols
UCR INSTRUCTION MANUAL
CO2gas inlet
Fuse rating
Electrical rating
plate
Product name, rated
voltage and frequency
are shown.
Potential equalization
terminal
Manufacturer
FUSES
T2AH250V
Timer
Only the exclusive hose and adapter can
be connected.
Only the exclusive cable
can be connected.
CE marking
MEDICAL DEVICE
ENDOSCOPIC
CO2REGULATION UNIT
MODEL: OLYMPUS UCR
INPUT: 100 – 240V
50/60Hz 40VA
Crossed-out wheeled
bin’ symbol
Rear panel
Authorized representative in
the European Community
Serial number
Serial number plate
Date of manufacture

Labels and Symbols
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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.

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Labels and Symbols
UCR INSTRUCTION MANUAL
Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742),
Extra low flow 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 representative in the European Community
Translation
Importer (into European Union)
Caution,
refer to instructions.

Important Information — Please Read Before Use
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UCR INSTRUCTION MANUAL
Intended use
The endoscopic CO2regulation unit has been designed to be used with Olympus gastrointestinal
endoscopes, lens cleaning sheath for surgical endoscope and ancillary equipment for CO2gas and
water feeding. Do not use the endoscopic CO2regulation unit for any purpose other than its intended
use.
Applicability of endoscopy, endoscopic treatment, and
endoscopic surgery
If there are official standards on the applicability of endoscopy, endoscopic treatment, and endoscopic
surgery that is defined by the hospital’s administration or other official institutions such as academic
societies on endoscopy or endoscopic surgery, follow that standard.
Before starting endoscopy, endoscopic treatment, and endoscopic surgery, thoroughly evaluate its
properties, purposes, effects, and possible risks (their natures, extent and probability). Perform
endoscopy, endoscopic treatment, and endoscopic surgery 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 examination/treatment/surgery methods that can be performed
in its place, and perform the endoscopy, endoscopic treatment, and endoscopic surgery only after
obtaining the consent of the patient.
Even after starting the endoscopy, endoscopic treatment, and endoscopic surgery, continue to
evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment/surgery 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 for 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, contact Olympus.
Important Information — Please Read Before Use

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Important Information — Please Read Before Use
UCR INSTRUCTION MANUAL
User qualifications
If there is an official standard on user qualifications to perform endoscopy, endoscopic treatment, and
endoscopic surgery that is defined by the medical administration or other official institutions, such as
academic societies on endoscopy or endoscopic surgery, 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, endoscopic treatment,
and endoscopic surgery following guidelines set by the academic societies on endoscopy or
endoscopic surgery, etc., and considering the 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 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 4
(IEC 60601-1-2: 2014).
When connecting to an instrument that complies with a previous edition of the EMC standard for
medical electrical equipment edition, the EMC characteristics could be vulnerable.
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.

Important Information — Please Read Before Use
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UCR INSTRUCTION MANUAL
Signal words
The following signal words are used throughout this manual:
Dangers, 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.
DANGER
• As a TYPE BF applied part, this endoscopic CO2regulation 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 CO2regulation unit to
the heart or any area near the heart.
−Never allow the hand instruments or another endoscope applied to or near the
heart to come in contact with an endoscope connected to this endoscopic CO2
regulation unit.
Indicates an imminently hazardous situation which, if not avoided, will result in
death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
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.
Indicates additional helpful information.
DANGER
WARNING
CAUTION
NOTE

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Important Information — Please Read Before Use
UCR INSTRUCTION MANUAL
DANGER
• 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 CO2regulation 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 CO2regulation unit, stop operation of the unit immediately and
contact Olympus.
−Do not prepare, inspect or use this CO2regulation unit with wet hands.
• Never install and operate the endoscopic CO2regulation unit in the following
locations. An explosion or fire may result because the endoscopic CO2regulation
unit is 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 nearby.
• Supply medical grade CO2gas only. Never use other kinds of gas. Using gases
other than CO2gas may result in fire, poisoning, complications, etc.
WARNING
• If the endoscopic CO2regulation unit is used with the upper/lower gastrointestinal
endoscopes, use it only for CO2gas/water feeding within the upper/lower digestive
tract. If the endoscopic CO2regulation unit is used with the lens cleaning sheath,
use it only for CO2gas feeding/spraying toward the objective lens of the endoscope
within the thoracic and abdominal cavities including female reproductive organs.
• If the endoscopic CO2regulation unit is used with the lens cleaning sheath, do not
feed spray/CO2gas to an open vessel directly. Do not use the lens cleaning sheath
near an open vessel or do not press the distal tip of the lens cleaning sheath
against tissues. Otherwise, gas embolism may result.

Important Information — Please Read Before Use
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UCR INSTRUCTION MANUAL
WARNING
• To prevent electrical shock hazards, the housing of the endoscopic CO2regulation
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 CO2regulation unit as a backup.
Power cord plug
Properly
grounded wall
mains outlet

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Important Information — Please Read Before Use
UCR INSTRUCTION MANUAL
WARNING
• Occurrences of hypercapnemia through CO2absorption 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 CO2regulation unit.
−Reference
• The endoscopic CO2regulation unit has no function of intraluminal pressure
measurement and automatic control.
• Always use the provided power cord with the endoscopic CO2regulation 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 CO2regulation unit OFF after use. If it is left ON
after examination/operation, an accidental contact with the start/stop switch may
start gas supply. This will not only empty the CO2gas cylinder but may also
increase the CO2concentration in the environment.
• Use the endoscopic CO2regulation unit only under the conditions described in
“Transportation, storage, and operating environments” on page 69. Use under
other conditions may not only impair the normal performance, but may also result in
equipment damage.
• Prepare spare CO2gas cylinders for quick replacement if the cylinder used during
the procedure should run out.
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.
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.

Important Information — Please Read Before Use
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UCR INSTRUCTION MANUAL
WARNING
• Be sure that this instrument is not used adjacent to or stacked with other equipment
(other than the components of this instrument or system) to avoid electromagnetic
interference.
• Electromagnetic interference may occur on this instrument near equipment marked
with the following symbol or other portable and mobile RF (Radio Frequency)
communications equipment such as cellular phones. If electromagnetic
interference occurs, mitigation measures may be necessary, such as reorienting or
relocating this instrument, or shielding the location.
CAUTION
• 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.
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 an irregularity in the endoscopic CO2regulation unit,
immediately stop using the endoscopic CO2regulation unit and withdraw the
endoscope from the patient slowly as described in the endoscope’s instruction
manual.
•TheCO
2gas 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.
• During use, always stop the device like light source from supplying air. If “Stop” is
not selected, a mixture of air and CO2may be supplied into the patient body.
• 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.

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Important Information — Please Read Before Use
UCR INSTRUCTION MANUAL
Use in combination with the lens cleaning sheath
WARNING
• Anytime you observe an irregularity in the endoscopic CO2regulation unit,
immediately stop using the endoscopic CO2regulation unit and withdraw the
endoscope from the patient slowly as described in the instruction manual for the
lens cleaning sheath.
• To prevent gas embolism caused by intra-abdominal over-pressurization from the
combined use of the lens cleaning sheath and a laser device, argon-enhanced
coagulator, or other gas supply devices, carefully read and understand the
following before using in case the insufflator is used in operation:
−When performing endoscopic operation using a lens cleaning sheath and a
laser device, argon-enhanced coagulator, or other gas supply devices
simultaneously, both instruments become a source of supply for gas.
Accordingly, the desired pressure in the abdomen is reached in a shorter time
than when a lens cleaning sheath is used alone. In these cases, be careful that
the cavity does not become over-pressurized. The laser device,
argon-enhanced coagulator, and other gas supply devices are not equipped to
monitor the cavity pressure (automatic termination of 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 infected area. We ask that the physicians make a suitable
judgment from a professional standpoint himself.
−If the insufflator emits a caution (caution light or alarm) for cavity
over-pressurization, quickly open the stopcock or valve of the trocar. Then,
reduce the amount of outflow from the laser device, argon-enhanced
coagulator, or other gas supply device. If use is continued while the alarm
sounds, there is a risk of gas embolism due to cavity over-pressurization.
• Be careful not to feed CO2too much during CO2gas feed or spraying. Excessive
CO2gas feed/spraying may cause pain to the patient and/or gas embolism.
Reduce the use of CO2gas feed and spraying at the requisite minimum level.
• In case the insufflator is used in operation, open the trocar cannula stopcock if the
pressure in the abdomen exceeds the set pressure by more than 5 mmHg.
• Do not attempt to insufflate the abdominal cavity using the lens cleaning sheath.
Otherwise, patient injury and/or gas embolism may result.
• Do not use the endoscopic CO2regulation unit in combination with other than the
compatible lens cleaning sheath (with the MAJ-1345, MAJ-1537, or MAJ-659, for
example). Otherwise, CO2gas is fed continuously and patient pain and gas
embolism can result.

1.1 Checking the package contents
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UCR INSTRUCTION MANUAL
Ch.1
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.
1.1 Checking the package contents
Endoscopic CO2regulation unit (UCR)
Endoscopic CO2regulation unit (UCR)
Accessories
Power cord Water container (MAJ-902)*1
*1 When the endoscopic CO2regulation unit is combined with the lens cleaning sheath, the water container
(MAJ-902) and Gas tube (MAJ-1741) are not used.
Gas tube (MAJ-1741)*1
Nut cover Instruction manual

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1.2 Optional items
UCR INSTRUCTION MANUAL
Ch.1
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 “System chart” on page 67.
1.2 Optional items