Olympus UHI-4 User manual

INSTRUCTIONS
HIGH FLOW INSUFFLATION UNIT
UHI-4

Contents
i
HIGH FLOW INSUFFLATION UNIT UHI-4
Contents
Labels and Symbols..................................................................... 1
Important Information — Please Read Before Use.................... 7
Intended use ............................................................................................ 7
Instruction manual .................................................................................... 7
User qualifications..................................................................................... 8
Instrument compatibility ........................................................................... 8
Reprocessing and storage ....................................................................... 8
Repair and modification ............................................................................ 9
Signal words ............................................................................................. 9
Dangers, warnings, and cautions.............................................................. 10
Security .................................................................................................... 17
Summary of Equipment Function.............................................................. 18
Chapter 1 Checking the Package Contents............................ 20
1.1 Checking the package contents...................................................... 20
1.2 Optional items ................................................................................. 21
Chapter 2 Instrument Nomenclature....................................... 25
2.1 Symbols and descriptions ............................................................... 25
2.2 Front panel...................................................................................... 28
2.3 Rear panel ...................................................................................... 32
2.4 Optional components ...................................................................... 34
Chapter 3 Installation and Connection ................................... 36
3.1 Installation workflow........................................................................ 36
3.2 Installation of the UHI-4 main unit................................................... 38
3.3 Connecting a CO2 cylinder ............................................................. 39
3.4 Connecting the medical gas pipeline adapter (MAJ-1084/1085) .... 43
3.5 Connecting the foot switch (MAJ-1939) .......................................... 44
3.6 Connecting the electrosurgical unit (ESG-400, UES-40) or the SonoSurg
generator (USG-400, SonoSurg-G2) .............................................. 45
3.7 Connecting the light source (CLV-190, CLV-S190) or the video system
center (OTV-S190).......................................................................... 52
3.8 Connecting to an AC mains supply................................................. 56
3.9 Connecting the insufflation tube and suction tube .......................... 58
Chapter 4 Inspection ................................................................ 65
4.1 Inspection workflow......................................................................... 65

Contents
ii HIGH FLOW INSUFFLATION UNIT UHI-4
4.2 Inspection of the cylinder hose for (MAJ-1080/1081/1082/1985/1986) 67
4.3 Inspection of the medical gas pipeline adapter (MAJ-1084/1085) .. 67
4.4 Inspection of the insufflation tube (MAJ-590) and suction tube (MAJ-591)
68
4.5 Inspection of the smoke evacuation foot switch (MAJ-1939).......... 69
4.6 Turning power ON........................................................................... 69
4.7 Inspection of the gas supply and caution for insufficient gas supply function
70
4.8 Inspection of insufflation ................................................................. 71
4.9 Inspection of alarm function ............................................................ 72
4.10 Inspection of UHI-4 operation when using a veress needle/trocar/port
device for transanal access............................................................. 73
4.11 Power OFF...................................................................................... 73
Chapter 5 Operation.................................................................. 74
5.1 Operating steps............................................................................... 76
5.2 Power supply .................................................................................. 78
5.3 Selecting the cavity mode ............................................................... 79
5.4 Setting the cavity pressure.............................................................. 80
5.5 Setting the flow rate ........................................................................ 81
5.6 Selecting the smoke evacuation mode ........................................... 82
5.7 Selecting the display mode ............................................................. 83
5.8 Insufflation....................................................................................... 85
5.9 Smoke evacuation system/function................................................. 86
5.10 Automatic smoke evacuation system/function (when using the
electrosurgical generator or the ultrasonic generator) .................... 88
5.11 Resetting the CO2 volume indicator ............................................... 91
5.12 Steps after use................................................................................ 92
5.13 Relief mode..................................................................................... 96
5.14 Automatic suction function .............................................................. 98
5.15 User mode ...................................................................................... 100
Chapter 6 Reprocessing, Storage, and Disposal ................... 103
6.1 General policy ................................................................................. 104
6.2 Precautions ..................................................................................... 105
6.3 Compatible Reprocessing Methods ................................................ 108
6.4 Detergent solution for manual cleaning........................................... 110
6.5 Surface disinfectant cleaner............................................................ 111
6.6 Water .............................................................................................. 111
6.7 Alcohol ............................................................................................ 112
6.8 Washer-Disinfector.......................................................................... 112
6.9 Steam sterilization (autoclaving) ..................................................... 116
6.10 Signs of degradation from reprocessing and its number of times ... 117

Contents
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HIGH FLOW INSUFFLATION UNIT UHI-4
6.11 Reprocessing workflow for High Flow Insufflation Unit (UHI-4) and
accessories ..................................................................................... 119
6.12 Reprocessing the High Flow Insufflation Unit (UHI-4) and Smoke
Evacuation Foot Switch (MAJ-1939)............................................... 121
6.13 Reprocessing Insufflation Tube (MAJ-590) and Suction Tube (MAJ-591)
126
6.14 Storage and Disposal...................................................................... 133
Chapter 7 Troubleshooting ...................................................... 136
7.1 Troubleshooting guide .................................................................... 136
7.2 Alarm functions ............................................................................... 140
7.3 Returning the high flow insufflation unit for repair........................... 142
Appendix ....................................................................................... 143
System chart ............................................................................................ 143
Specifications ............................................................................................ 146
EMC information ....................................................................................... 155

Contents
iv HIGH FLOW INSUFFLATION UNIT UHI-4

Labels and Symbols
1
HIGH FLOW INSUFFLATION UNIT UHI-4
Labels and Symbols
Safety-related labels and symbols are attached to the instrument at the locations
shown below.
If labels or symbols are missing or illegible, contact Olympus.
HIGH FLOW INSUFFLATION UNIT (UHI-4)
CSA marking
CE marking
Crossed-out wheeled bin’ symbol
Electrical rating plate
Potential equalization
terminal
CO2 gas inlet
Manufacturer
Fuse rating
Maximum supply pressure rating
16.2MPa
Instruction manual
reference mark
Serial number
Date of manufacture
MEDICAL DEVICE
HIGH FLOW INSUFFLATION UNIT
MODEL: UHI-4
POWER INPUT: 100-240V~
50/60Hz 110VA
Authorized representative in
the European Community
Serial number plate

2
Labels and Symbols
HIGH FLOW INSUFFLATION UNIT UHI-4
Front panel
The UDI label is required by some countries’ regulations regarding the
identification of a medical device also known as Unique Device
Identification (UDI).
UDI label

Labels and Symbols
3
HIGH FLOW INSUFFLATION UNIT UHI-4
CYLINDER HOSE (PIN) FOR UHI-3 (MAJ-1080)
Name plate
Name plate
Caution

4
Labels and Symbols
HIGH FLOW INSUFFLATION UNIT UHI-4
CYLINDER HOSE (DIN) FOR UHI-3 (MAJ-1081)
CYLINDER HOSE (ISO) FOR UHI-3 (MAJ-1082)
Name plate
Caution
Name plate
SUPPLY CO2 GAS FOR MEDICAL USE ONLY.
NEVER USE OTHER KINDS OF GASES.
USE WITH OLYMPUS PRODUCTS.
NEVER CONNECT WITH OTHER UNIT.
SUPPLY CO2 GAS FOR MEDICAL USE ONLY.
NEVER USE OTHER KINDS OF GASES.
USE WITH OLYMPUS PRODUCTS.
NEVER CONNECT WITH OTHER UNIT.
Caution

Labels and Symbols
5
HIGH FLOW INSUFFLATION UNIT UHI-4
Back cover of this instruction manual
Manufacturer
Authorized representative in the European Community
Translation
Importer (into European Union)

6
Labels and Symbols
HIGH FLOW INSUFFLATION UNIT UHI-4

Important Information — Please Read Before Use
7
HIGH FLOW INSUFFLATION UNIT UHI-4
Important Information — Please Read
Before Use
Intended use
This instrument is intended to insufflate the abdominal cavity, and provides
automatic suction and smoke evacuation to facilitate laparoscopic observation,
diagnosis and treatment.
This instrument is used to insufflate the colon to facilitate endoscopic
observation, diagnosis and treatment.
Do not use the high flow insufflation unit for any other purpose.
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 which will be used during the procedure and use the
instrument 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.
Terms used in this manual
Wall mains outlet
An electrical outlet that has a terminal used exclusively for grounding.

8
Important Information — Please Read Before Use
HIGH FLOW INSUFFLATION UNIT UHI-4
User qualifications
If there is an official standard on the qualification for endoscopy and endoscopic
surgery that is defined by the medical administration or other official institutions
such as the academic society for endoscopic surgery, follow that standard. If
there is no official qualification standard, the operator of this equipment must be
a physician approved by the medical safety manager of the hospital or person in
charge of the department (department of surgery, etc.). The medical safety
manager of the hospital or person in charge of the department should select a
physician who is capable of safely performing the planned endoscopy and
endoscopic surgery by following the official guidelines set by the academic
society on endoscopic surgery, etc. and consider the difficulty of endoscopy and
endoscopic surgery.
Instrument compatibility
Refer to “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 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.
Reprocessing and storage
This instrument was not disinfected or sterilized before shipment. Before using
this instrument for the first time, reprocess it according to the instructions given
in Chapter 6, “Reprocessing, Storage, and Disposal”.
After using this instrument, reprocess and store it according to the instructions
given in Chapter 6.
Improper and/or incomplete reprocessing or storage can present an infection
control risk, cause equipment damage or reduce performance.

Important Information — Please Read Before Use
9
HIGH FLOW INSUFFLATION UNIT UHI-4
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.
Signal words
The following signal words are used throughout this manual:
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.

10
Important Information — Please Read Before Use
HIGH FLOW INSUFFLATION UNIT UHI-4
Dangers, warnings, and cautions
Follow the dangers, warnings, and cautions given below when handling this
device.
This information is to be supplemented by the dangers, warnings, and cautions
given in each chapter.
• The UHI-4 is not explosion-proof. Never install or operate it in
the presence of flammable gases.
• 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 of non-medical grade, oil
polluted CO2 might result in a malfunction of the insufflation
pressure control stage, causing a serious patient risk. Use
the hose for cylinder or adapter for medical gas pipeline as
described in this instruction manual to connect the CO2 gas
cylinder or medical gas pipeline.
• Use of this device for cavity distention is contraindicated
whenever endoscopy is contraindicated. Refer to the
operator’s manual of your endoscope for absolute and
relative the contraindications.
• This device is contraindicated for hysteroscopic insufflation,
i.e., it must not be used for intrauterine distention.
• Strictly observe the following precautions. Failure to do so
may place the patient and medical personnel in danger of an
electric shock.
When the high flow insufflation 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 high flow insufflation unit, stop
operation of the unit immediately and contact Olympus.
Do not prepare, inspect, or use this high flow insufflation
unit with wet hands.

Important Information — Please Read Before Use
11
HIGH FLOW INSUFFLATION UNIT UHI-4
• Never install and operate the high flow insufflation 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 high flow
insufflation unit is not explosion-proof.
• Position the patient port of the insufflator and as much of the
associated tubing as is practical above the insufflation site,
so that any patient fluids inadvertently entering the tubing do
not drain back into the insufflator via gravity.
• Always keep the gas cylinder in the upright position. Fasten
the cylinder to a wall or another stable structure to prevent it
from toppling. If the gas cylinder is placed horizontally or in
an inclined position, liquefied CO2 may be transmitted into
the insufflation channel inside the UHI-4 and normal
insufflation may become impossible.
• To prevent gas embolism caused by intra-abdominal
over-pressurization from the combined use of an insufflator
and a laser device, argon-enhanced coagulator or other gas
supply devices, carefully read and understand the following
before using:
When performing endoscopic using an insufflator 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 pneumoperitoneum device 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.

12
Important Information — Please Read Before Use
HIGH FLOW INSUFFLATION UNIT UHI-4
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.
• The automatic and relief functions may not work to relieve an
overflow of gas depending on the capabilities of the
connected suction device/equipment. In this event, reduce
the amount of overflow from the laser and gas supply
devices, or open the cock of the tracar and the valves. Also
keep in mind that this device alone does not perform the
function of suctioning the gas; be sure to connect this device
to the suction device/equipment through the suction tube.
• When relief mode is set to ON, cavity gas and/or body fluids
(e.g., blood) can flow backward into and potentially
contaminate the equipment. To prevent this, Olympus
strongly recommends the use of a disposable filter in the
CO2 supply line between the UHI-4 and the patient. Olympus
recommends filter type PALL OR01H (0.2 m, hydrophobic)
or equivalent filters; contact Olympus for further details.
• If a filter is not used and fluid (e.g., blood) flows back into the
insufflation tube, make sure that it does not enter the UHI-4.
Should any fluids enter the UHI-4, immediately terminate its
use and contact Olympus.
• Olympus strongly recommends the use of a disposable filter
in the CO2 supply line between the UHI-4 and the patient
even when the relief mode will not be used.
• To reduce the risk of an electric shock, do not remove the
cover of the insufflator.
• To prevent operator shock and instrument damage, keep
liquids away from all electrical equipment. If fluid enters the
high flow insufflation unit, stop operation immediately and
contact Olympus.
• Always use the UHI-4 as outlined in this instruction manual.
Improper use will not only impair functions and prevent
optimum performance, but may cause equipment damage
and/or complications. Before each use, always inspect the
equipment as outlined in this instruction manual.

Important Information — Please Read Before Use
13
HIGH FLOW INSUFFLATION UNIT UHI-4
• To prevent electric shock hazards, the housing of the UHI-4
must be grounded. Always connect the power cord plug to a
properly grounded hospital grade AC outlet (wall mains
outlet).
• Use this device in an environment equipped to accommodate
open surgery and have the hospitalization plan prepared in
case any problem occurs that may not be resolved by
performing endoscopic surgery.
• Prepare spare CO2 cylinders for quick replacement if the
cylinder used during the procedure should run out.
• To ensure that the operation can be completed without
complication in the case of a malfunction, prepare a spare
UHI-4 unit as a backup.
• During use, especially when a high gas flow rate is selected,
a large volume of CO2 will be used. 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.
• Only use the UHI-4 under the conditions described in
“Operating environment” in the Appendix. Use under other
conditions may not only impair normal performance, but may
also result in equipment damage.

14
Important Information — Please Read Before Use
HIGH FLOW INSUFFLATION UNIT UHI-4
•To avoid complications, monitor patient parameters such as
endotidal CO2, electrocardiogram, body temperature, etc.
while using the UHI-4.
• Metabolic Acidosis and resultant cardiac irregularity.
Prolonged cavity pressures greater than 20 mmHg should be
avoided. This can cause any of the following:
Decreased respiration with compromised
diaphragmatic excursion
Decreased venous return
Decreased cardiac output
Acidosis
• Excessive flow rates and/or pressures may result in an
excessive absorption of CO2 and/or gas embolism. The
cavity can be adequately distended using a maximum
pressure of 20 mmHg. It is seldom necessary to use a cavity
pressure greater than 20 mmHg. Little intravasation should
occur at these levels. Pressures over 20 mmHg are rarely
necessary and will increase the amount and the rapidity of
intravasation of gas. Adequate respiration helps avoid
problems related to CO2.
– 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.
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.