ucr_endoscopic_co2_regulation_unit_instructions_nov.pdf
Page 1
INSTRUCTIONS
ENDOSCOPIC CO2 REGULATION UNIT
OLYMPUS UCR
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Page 3
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 .......................................
17
2.1
Symbols and descriptions ...............................................................
17
2.2
Front panel......................................................................................
18
2.3
Rear panel ......................................................................................
20
2.4
Cylinder hose (MAJ-1080) ..............................................................
22
2.5
Gas tube (MAJ-1741)......................................................................
22
2.6
Optional components ......................................................................
23
Installation and Connection ...................................
24
3.1
Installation work flow.......................................................................
24
3.2
Installation of the endoscopic CO2 regulation unit ..........................
25
3.3
Connecting a CO2 gas cylinder.......................................................
26
3.4
Connecting the medical gas pipeline adapter (MAJ-1084, MAJ-1085) 28
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
30
and extra low flow gas tube (MAJ-1816)........................................
32
Connecting the water container and endoscope.............................
33
ENDOSCOPIC CO2 REGULATION UNIT UCR
i
Page 4
Contents
Chapter 4
Inspection.................................................................
34
4.1
Inspection work flow........................................................................
35
4.2
Inspection of the cylinder hose (MAJ-1080)....................................
36
4.3
Inspection of the medical gas pipeline adapter (MAJ-1084, MAJ-1085)36
4.4
Inspection of the gas tube (MAJ-1741), low flow gas tube (MAJ-1742),
and extra low flow gas tube (MAJ-1816).........................................
37
Inspection of the endoscopic CO2 regulation unit ...........................
38
Operation..................................................................
43
5.1
Operation flow .................................................................................
44
5.2
Gas supplying and water feeding operation....................................
47
5.3
After use..........................................................................................
48
Care, Storage, and Disposal ...................................
50
6.1
General policy .................................................................................
50
6.2
Precautions .....................................................................................
51
6.3
Compatible reprocessing methods and chemical agents................
52
6.4
Cleaning of CO2 regulation unit, cylinder hose and
gas pipeline adapter........................................................................
57
6.5
Storing CO2 regulation unit, cylinder hose and gas pipeline adapter
58
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
Disinfecting the gas tube (MAJ-1741), low flow gas tube (MAJ-1742),
and extra low flow gas tube (MAJ-1816).........................................
6.8
6.9
59
60
Rinsing the gas tube (MAJ-1741), low flow gas tube (MAJ-1742),
and extra low flow gas tube (MAJ-1816).........................................
60
Sterilization .....................................................................................
62
6.10 Storing the gas tube (MAJ-1741), low flow gas tube (MAJ-1742),
and extra low flow gas tube (MAJ-1816).........................................
64
6.11 Care and storage of the water container (MAJ-902) .......................
64
6.12 Disposal ..........................................................................................
64
Chapter 7
ii
Troubleshooting ......................................................
65
7.1
Troubleshooting guide ....................................................................
65
7.2
Returning the endoscopic CO2 regulation unit for repair ................
66
Appendix........................................................................................
67
System chart ............................................................................................
67
Specifications ............................................................................................
69
EMC information........................................................................................
73
ENDOSCOPIC CO2 REGULATION UNIT UCR
Page 5
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
CSA/UL marking
Caution that only the
exclusive cable can be
connected.
Timer
Potential equalization
terminal
Electrical rating
plate
Product name, rated
voltage and frequency
are shown.
ENDOSCOPIC
CO2 REGULATION UNIT
MODEL: OLYMPUS UCR
INPUT: 100 – 120V
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.
ENDOSCOPIC CO2 REGULATION UNIT UCR
1
Page 6
Labels and Symbols
Cylinder hose (MAJ-1080)
Refer to instructions
Gas tube (MAJ-1741), Low flow gas tube (MAJ-1742),
Extra low flow gas tube (MAJ-1816)
Refer to instructions
Gas tube ID indications on tags are shown
2
“HIGH”
(MAJ-1741)
“MED”
(MAJ-1742)
“LOW”
(MAJ-1816)
ENDOSCOPIC CO2 REGULATION UNIT UCR
Page 7
Labels and Symbols
Back cover of this instruction manual
Manufacturer
Authorized representative in the European Community
ENDOSCOPIC CO2 REGULATION UNIT UCR
3
Page 8
Labels and Symbols
4
ENDOSCOPIC CO2 REGULATION UNIT UCR
Page 9
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.
ENDOSCOPIC CO2 REGULATION UNIT UCR
5
Page 10
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.
6
ENDOSCOPIC CO2 REGULATION UNIT UCR
Page 11
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 light source
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 endoscopic CO2
regulation unit.
ENDOSCOPIC CO2 REGULATION UNIT UCR
7
Page 12
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.
8
•
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
Page 13
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.
ENDOSCOPIC CO2 REGULATION UNIT UCR
9
Page 14
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.
10
•
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 perfuration.
•
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
Page 15
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
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.
ENDOSCOPIC CO2 REGULATION UNIT UCR
11
Page 16
Important Information — Please Read Before Use
12
ENDOSCOPIC CO2 REGULATION UNIT UCR
Page 17
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
Gas tube (MAJ-1741)
Endoscopic CO2 regulation unit (UCR)
Water container (MAJ-902)
Cap
Cylinder hose for UHI-3∗1
Wrench
Cylinder hose for UHI-3 (MAJ-1080)∗1
∗1
Instruction manual
The endoscopic CO2 regulation unit is compatible with the cylinder hose for UHI-3 (MAJ-1080).
ENDOSCOPIC CO2 REGULATION UNIT UCR
13
Page 18
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.
•
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 nose
For other equipent combinations, refer to the “ System chart” in the Appendix.
Low flow gas tube (MAJ-1742)
Extra low flow gas tube (MAJ-1816)
14
ENDOSCOPIC CO2 REGULATION UNIT UCR
Page 19
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 for UHI-3 (MAJ-1084, MAJ-1085).
ENDOSCOPIC CO2 REGULATION UNIT UCR
15
Page 20
Chapter 1 Checking the Package Contents
16
ENDOSCOPIC CO2 REGULATION UNIT UCR
Page 21
Chapter 2 Instrument Nomenclature
Chapter 2 Instrument Nomenclature
2.1
Symbols and descriptions
Front panel
Power ON/OFF
Gas source pressure
Start
CO2 gas outlet
Stop
Type BF applied part
Rear panel
CO2 gas inlet
Timer
Serial number
Potential equalization
terminal
Fuse
Alternating current
Refer to instructions.
ENDOSCOPIC CO2 REGULATION UNIT UCR
17
Page 22
Chapter 2 Instrument Nomenclature
2.2
Front panel
4. Start/stop switch
5. Start indicator
6. Gas flow indicator
3. Gas pressure display
2. Power indicator
7. CO2 gas outlet
1. Power switch
18
ENDOSCOPIC CO2 REGULATION UNIT UCR
Page 23
Chapter 2 Instrument Nomenclature
1. Power switch
This switch is pressed to turn the endoscopic CO2 regulation unit ON or
OFF.
2. Power indicator
Lights up when the endoscopic CO2 regulation unit is ON.
3. Gas pressure display
In the “Cylinder” mode, the Gas pressure display indicates the supply
pressure of the connected CO2 cylinder. The red LED at the bottom is
illuminated when the gas supply is unavailable due to a drop of the supply
pressure. In the “Pipeline” mode, the top green LED is illuminated.
4. Start/stop switch
Press in “Stop” mode to light up the start indicator and start the gas supply.
Pressing the switch during gas supply extinguishes the start indicator and
stops the gas flow.
5. Start indicator
The indicator blinks when the timer is set to “LONG” or “SHORT”, and
illuminates steadily when the timer is “OFF”. The indicator is not illuminated
in the stop mode regardless of timer ON/OFF.
6. Gas flow indicator
The gas flow indicator illuminates green when CO2 gas is supplied, and
extinguished when no gas is supplied. The red LED lights to give an alarm
warning.
7. CO2 gas outlet
Connect the gas supply tube here.
ENDOSCOPIC CO2 REGULATION UNIT UCR
19
Page 24
Chapter 2 Instrument Nomenclature
2.3
Rear panel
1. Timer switch
3. Potential equalization terminal
2. System connector
5. CO2 gas inlet
4. AC power inlet
6. Gas source selection switch
20
ENDOSCOPIC CO2 REGULATION UNIT UCR
Page 25
Chapter 2 Instrument Nomenclature
1. Timer switch
Select the timer period “LONG”, “SHORT” or “OFF”.
2. System connector
This terminal is reserved for future system expansion.
3. 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 inlet
Connect the cylinder hose (MAJ-1080) or medical gas pipeline adapter
(MAJ-1084, MAJ-1085) here.
6. Gas source selection switch
Select the gas supply source “Cylinder” mode or “Pipeline” mode.
ENDOSCOPIC CO2 REGULATION UNIT UCR
21
Page 26
Chapter 2 Instrument Nomenclature
2.4
Cylinder hose (MAJ-1080)
Clamp
This clamp connects the
cylinder hose to the gas
cylinder.
Hose
Pin
Packing
Connector
Use the supplied wrench to connect this
connector to the CO2 gas inlet on the rear
panel of the endoscopic CO2 regulation unit.
2.5
Gas tube (MAJ-1741)
Tube
Instrument-side connector
Connect to the CO2 gas outlet on the
front panel of the endoscopic CO2
regulation unit.
Water container-side connector
Connect to the water container.
22
ENDOSCOPIC CO2 REGULATION UNIT UCR