Olympus UHI-3 User manual

USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician.
INSTRUCTIONS
HIGH FLOW INSUFFLATION UNIT
UHI-3

Contents
i
Contents
Labels and Symbols..................................................................... 1
Important Information — Please Read Before Use.................... 4
Intended use ............................................................................................ 4
Instruction manual .................................................................................... 4
User qualifications .................................................................................... 4
Instrument compatibility ............................................................................ 5
Reprocessing and storage ....................................................................... 5
Repair and modification ........................................................................... 5
Signal words ............................................................................................. 5
Dangers, warnings and cautions .............................................................. 6
Chapter 1 Checking the Package Contents............................ 11
1.1 Checking the package contents...................................................... 11
1.2 Optional items ................................................................................. 12
Chapter 2 Instrument Nomenclature....................................... 13
2.1 Symbols and descriptions ............................................................... 13
2.2 Front panel...................................................................................... 16
2.3 Rear panel ...................................................................................... 20
2.4 Cylinder hose (PIN) for UHI-3 (MAJ-1080) ..................................... 21
2.5 Optional components ...................................................................... 21
Chapter 3 Installation and Connection ................................... 23
3.1 Installation of the UHI-3 main unit................................................... 23
3.2 Connecting to an AC mains supply................................................. 24
3.3 Connecting a CO2gas cylinder....................................................... 25
3.4 Connecting the medical gas pipeline adaptor (MAJ-1084/1085) .... 27
3.5 Connecting the foot switch (MH-317).............................................. 28
3.6 Connecting the insufflation tube and suction tube .......................... 29
3.7 Connecting the Electrosurgical Unit (UES-40) or the SonoSurg
generator (SonoSurg-G2) ............................................................... 33
Chapter 4 Inspection ................................................................ 35
4.1 Inspection of the UHI-3 main unit.................................................... 35
4.2 Inspection of the cylinder hose for UHI-3........................................ 38
4.3 Inspection of the medical gas pipeline adaptor (MAJ-1084/1085) .. 38
4.4 Inspection of the foot switch (MH-317) ........................................... 38
4.5 Inspection of the insufflation tube and suction tube ........................ 39

Contents
ii
4.6 Inspection of UHI-3 operation when using a veress needle/trocar.. 40
Chapter 5 Operation.................................................................. 41
5.1 Relief mode..................................................................................... 42
5.2 Inserting the veress needle ............................................................. 44
5.3 Insufflation....................................................................................... 44
5.4 Automatic suction............................................................................ 46
5.5 Smoke evacuation (optional foot switch [MH-317] required)........... 49
5.6 Automatic exhaust .......................................................................... 51
5.7 Resetting the CO2gas volume indicator ......................................... 52
5.8 After use.......................................................................................... 52
Chapter 6 Care, Storage and Disposal .................................... 54
6.1 General policy ................................................................................. 54
6.2 Precautions ..................................................................................... 55
6.3 Compatible reprocessing methods and chemical agents................ 56
6.4 Cleaning of the UHI-3 main body, foot switch, cylinder hose and
medical gas pipeline adaptor .......................................................... 57
6.5 Storage of the UHI-3 main body, foot switch, cylinder hose and
medical gas pipeline adaptor .......................................................... 58
6.6 Cleaning the insufflation tube (MAJ-590) and suction tube (MAJ-591)
prior to sterilization .......................................................................... 58
6.7 Sterilization of the insufflation tube (MAJ-590) and suction tube
(MAJ-591) ....................................................................................... 59
6.8 Storage of the insufflation tube (MAJ-590), suction tube (MAJ-591) 60
6.9 Disposal .......................................................................................... 60
Chapter 7 Troubleshooting ...................................................... 61
7.1 Troubleshooting guide .................................................................... 61
7.2 Alarm functions ............................................................................... 65
7.3 Returning the high flow insufflation unit for repair ........................... 67
Appendix........................................................................................ 68
System chart ............................................................................................ 68
Specifications ............................................................................................ 71

Labels and Symbols
1
HIGH FLOW INSUFFLATION UNIT UHI-3
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.
UHI-3 main unit
Symbol mark ( )
Refer to instructions.
Serial number
Electrical rating plate
Product name, rated voltage and
frequency are shown.
Rear panel

2
Labels and Symbols
HIGH FLOW INSUFFLATION UNIT UHI-3
CYLINDER HOSE (PIN) FOR UHI-3 (MAJ-1080)
Name plate
Symbol mark ( )
Refer to instructions.
Name plate
SUPPLY CO2GAS FOR MEDICAL USE ONLY.
NEVER USE OTHER KINDS OF GASES.
USE WITH OLYMPUS PRODUCTS.
NEVER CONNECT WITH OTHER UNIT.

Labels and Symbols
3
HIGH FLOW INSUFFLATION UNIT UHI-3
Back cover of this instruction manual
Manufacturer
Authorized representative in the European Community

4
Important Information — Please Read Before Use
HIGH FLOW INSUFFLATION UNIT UHI-3
Important Information — Please Read
Before Use
Intended use
This instrument has been designed for insufflation of the abdominal cavity, and
automatic suction and smoke evacuation. This instrument uses CO2gas for
distension, and it may be used for diagnostic and/or operative laparoscopy.
Do not use this instrument for any purpose other than its intended use.
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
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.
Terms used in this manual
Wall mains outlet
An electrical outlet that has a terminal used exclusively for grounding.
User qualifications
The operator of this instrument must be a physician or medical personnel under
the supervision of a physician and must have received sufficient training in
laparoscopic surgery.
This manual, therefore, does not explain or discuss laparoscopic surgery.

Important Information — Please Read Before Use
5
HIGH FLOW INSUFFLATION UNIT UHI-3
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.
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, “Care, 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.
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.

6
Important Information — Please Read Before Use
HIGH FLOW INSUFFLATION UNIT UHI-3
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.
Dangers, warnings and cautions
Follow the dangers, warnings and cautions given below when handling this
instrument.
This information is to be supplemented by the dangers, warnings and cautions
given in each chapter.
• The UHI-3 is not explosion-proof. Never install or operate it in
the presence of flammable gases.
• Supply medical grade CO2gas only. Never use other kinds
of gas. Using gases other than CO2gas may result in fire,
poisoning, complications, etc. Use of non-medical grade, oil
polluted CO2might result in a malfunction of the insufflation
pressure control stage, causing a serious patient risk. Use
the hose for cylinder or adaptor for medical gas pipeline as
described in this instruction manual to connect the CO2gas
cylinder or medical gas pipeline.
• Use of this device for intra-abdominal distention is
contraindicated whenever laparoscopy is contraindicated.
• This device is contraindicated for hysteroscopic insufflation,
i.e., it must not be used for intrauterine distention.

Important Information — Please Read Before Use
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HIGH FLOW INSUFFLATION UNIT UHI-3
• 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 CO2may be transmitted into
the insufflation channel inside the UHI-3 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 laparoscopy 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 abdomen does not become
over-pressurized.
The laser device, argon-enhanced coagulator and other
gas supply devices are not equipped to monitor the
abdominal 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 warning (warning light or alarm)
for intra-abdominal 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 intra-abdominal
over-pressurization.

8
Important Information — Please Read Before Use
HIGH FLOW INSUFFLATION UNIT UHI-3
• When relief mode is set to ON, intra-abdominal 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 CO2supply line between the UHI-3 and the patient.
Olympus recommends filter type PALL OR01H (0.2 μm,
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-3.
Should any fluids enter the UHI-3, immediately terminate its
use and contact Olympus.
• Olympus strongly recommends the use of a disposable filter
in the CO2supply line between the UHI-3 and the patient
even when the relief mode will not be used.
• To reduce the risk of 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
UHI-3, stop operation immediately and contact Olympus.
• Always use the UHI-3 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.
• To prevent electrical shock hazards, the housing of the UHI-3
must be grounded. Always connect the power cord plug to a
properly grounded hospital grade AC outlet (wall mains
outlet).
Properly
grounded wall
mains outlet
Power plug

Important Information — Please Read Before Use
9
HIGH FLOW INSUFFLATION UNIT UHI-3
• Use this instrument 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 CO2gas 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-3 unit as a backup.
• During use, especially when a high gas flow rate is selected,
a large volume of CO2gas will be used. To prevent an
oxygen deficiency in the operating room, ensure that the
operating room is properly ventilated.
• Only use the UHI-3 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.
• To avoid complications, monitor patient parameters such as
endotidal CO2, electrocardiogram, body temperature, etc.,
while using the UHI-3.
• Metabolic Acidosis and resultant cardiac irregularity.
Prolonged intra-abdominal 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 CO2and/or gas embolism. The
abdomen can be adequately distended using a maximum
pressure of 20 mmHg. It is seldom necessary to use an
abdominal pressure greater than 20 mmHg. Little
intravasation or tubal passage should occur at these levels.
Pressures over 20 mmHg are rarely necessary and will
increase the amount and the rapidity of intravasation and
tubal passage of gas. Adequate respiration helps avoid
problems related to CO2.
• Idiosyncratic reactions. Patients with sickle cell disease or
pulmonary insufficiency may have an increased risk of
metabolic imbalance related to excessive CO2absorption.

10
Important Information — Please Read Before Use
HIGH FLOW INSUFFLATION UNIT UHI-3
• Other possible complications include CO2embolization,
hypothermia and carbonic acid irritation of the diaphragm.
Direct access of insufflated CO2gas to the vascular system
(e.g. through an open vessel in the intra-abdominal cavity, or
an improperly inserted veress needle) may result in gas
embolism.
• Operative procedures should only be performed with
insufflators capable of flow rates of at least 4 – 10 L/min.
Insufflators with lower maximum flow rates should only be
used for diagnostic procedures.
Before using a veress needle and trocar, inspect the items as
outlined in Section 4.6, “Inspection of UHI-3 operation when
using a veress needle/trocar”.
As defined by the international safety standard
(IEC 60601-1), medical electrical equipment is classified into
the following types: Type CF applied parts (the instrument
can safely be applied to any part of the body, including the
heart), and Type B/BF applied parts (the instrument can
safely be applied to any organ except the heart). Which part
of the body the endoscope or accessories can safely be
applied to depends on the classification of the equipment to
which the instruments are connected. Before beginning the
procedure, review the current leakage classification type of
each instrument that you will use for the procedure.
Classification types are clearly specified on the instruments
and in the instruments’ instruction manuals.
Symbol Classification
Type CF applied part
Type BF applied part
Type B applied part

Chapter 1 Checking the Package Contents
11
HIGH FLOW INSUFFLATION UNIT UHI-3
Chapter 1 Checking the Package
Contents
1.1 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.
This equipment was not disinfected or sterilized before shipment. Before using
this equipment for the first time, reprocess it according to the instructions given
in Chapter 6.
Insufflation tube (MAJ-590)
High flow insufflation unit (UHI-3) Cylinder hose
(PIN) for UHI-3
Small diameter tube
(transparent)
Tube with green line Differential diameter
connector
Small luer-lock
connector
Y-shaped connector Extension tube
Suction tube (MAJ-591)
Filter connecting
tube
Tube
(transparent)
Large luer-lock connector Instruction manual
Wrench
Power cord

12
Chapter 1 Checking the Package Contents
HIGH FLOW INSUFFLATION UNIT UHI-3
1.2 Optional items
FOOT SWITCH (MH-317)
MEDICAL GAS PIPELINE ADAPTOR (NIST) FOR UHI-3
(MAJ-1084)
MEDICAL GAS PIPELINE ADAPTOR (DISS) FOR UHI-3
(MAJ-1085)
ADAPTOR FOR MEDICAL GAS PIPELINE Wrench

Chapter 2 Instrument Nomenclature
13
HIGH FLOW INSUFFLATION UNIT UHI-3
Chapter 2 Instrument Nomenclature
2.1 Symbols and descriptions
Power switch
CO2INSUFFLATION connector
CO2SUCTION control pinch valve
CYLINDER PRESSURE
ABDOMINAL PRESSURE section
Power ON/OFF
Abdominal pressure
Warning, excessive pressure
Warning, tube obstructed
Relief mode

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Chapter 2 Instrument Nomenclature
HIGH FLOW INSUFFLATION UNIT UHI-3
FLOW RATE section
VOLUME section
START
STOP
FOOTSWITCH connector
CO2GAS INLET
Flow rate
High mode
Medium mode
Low mode
Total volume used
Reset

Chapter 2 Instrument Nomenclature
15
HIGH FLOW INSUFFLATION UNIT UHI-3
Others
Alternating current
Circuit breaker
Equipotential terminal
Refer to instructions.

16
Chapter 2 Instrument Nomenclature
HIGH FLOW INSUFFLATION UNIT UHI-3
2.2 Front panel
Front panel
1. POWER switch
2. Abdominal pressure
control switches 3. Flow mode selector
4. Flow rate control switches
5. RESET switch
6. CO2suction control
pinch valve
7. CO2insufflation
connector
8. STOP switch
9. START switch