uhi-3_high_flow_insufflation_instructions.pdf
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INSTRUCTIONS
HIGH FLOW INSUFFLATION UNIT
UHI-3
Page 3
Contents
Contents
Labels and Symbols .....................................................................
1
Important Information — Please Read Before Use....................
5
Intended use ............................................................................................
5
Instruction manual ....................................................................................
5
User qualifications ....................................................................................
5
Instrument compatibility ............................................................................
6
Reprocessing and storage .......................................................................
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
Instrument Nomenclature .......................................
16
2.1
Symbols and descriptions ...............................................................
16
2.2
Front panel......................................................................................
19
2.3
Rear panel ......................................................................................
23
2.4
Optional components ......................................................................
24
Installation and Connection ...................................
26
3.1
Installation of the UHI-3 main unit...................................................
26
3.2
Connecting to an AC mains supply.................................................
27
3.3
Connecting a CO2 gas cylinder.......................................................
28
3.4
Connecting the medical gas pipeline adaptor (MAJ-1084/1085) ....
30
3.5
Connecting the foot switch (MH-317)..............................................
32
3.6
Connecting the insufflation tube and suction tube ..........................
33
3.7
Connecting the Electrosurgical Unit (UES-40) or the SonoSurg
generator (SonoSurg-G2) ...............................................................
37
Inspection ................................................................
39
4.1
Inspection of the UHI-3 main unit....................................................
39
4.2
Inspection of the cylinder hose for UHI-3........................................
42
4.3
Inspection of the medical gas pipeline adaptor (MAJ-1084/1085) ..
42
4.4
Inspection of the foot switch (MH-317) ...........................................
42
4.5
Inspection of the insufflation tube and suction tube ........................
43
4.6
Inspection of UHI-3 operation when using a veress needle/trocar .
44
Chapter 2
Chapter 3
Chapter 4
HIGH FLOW INSUFFLATION UNIT UHI-3
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Contents
Chapter 5
Operation..................................................................
45
5.1
Relief mode .....................................................................................
46
5.2
Inserting the veress needle .............................................................
48
5.3
Insufflation.......................................................................................
48
5.4
Automatic suction............................................................................
50
5.5
Smoke evacuation (optional foot switch [MH-317] required)...........
53
5.6
Automatic exhaust ..........................................................................
55
5.7
Resetting the CO2 gas volume indicator .........................................
56
5.8
After use..........................................................................................
56
Care, Storage and Disposal ....................................
58
6.1
General policy .................................................................................
58
6.2
Precautions .....................................................................................
59
6.3
Compatible reprocessing methods and chemical agents................
60
6.4
Cleaning of the UHI-3 main body, foot switch, cylinder hose and medical
gas pipeline adaptor........................................................................
61
6.5
Storage of the UHI-3 main body, foot switch, cylinder hose and medical gas
pipeline adaptor ..............................................................................
62
6.6
Cleaning the insufflation tube (MAJ-590) and suction tube (MAJ-591) prior
to sterilization ..................................................................................
62
6.7
Sterilization of the insufflation tube (MAJ-590) and suction tube
(MAJ-591) .......................................................................................
63
6.8
Storage of the insufflation tube (MAJ-590), suction tube (MAJ-591)
64
6.9
Disposal ..........................................................................................
64
Troubleshooting ......................................................
65
7.1
Troubleshooting guide ....................................................................
65
7.2
Alarm functions ...............................................................................
69
7.3
Returning the high flow insufflation unit for repair ...........................
71
Appendix........................................................................................
73
System chart ............................................................................................
73
Specifications ............................................................................................
76
EMC information .......................................................................................
83
Chapter 6
Chapter 7
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HIGH FLOW INSUFFLATION UNIT UHI-3
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Labels and Symbols
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
Electrical rating plate
Product name, rated voltage and
frequency are shown.
Crossed-out wheeled bin’ symbol
Symbol mark (
)
Refer to instructions.
Serial number
Rear panel
HIGH FLOW INSUFFLATION UNIT UHI-3
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Labels and Symbols
CYLINDER HOSE (PIN) FOR UHI-3 (MAJ-1080)
Name plate
Symbol mark (
)
Refer to instructions.
SUPPLY CO2 GAS FOR MEDICAL USE ONLY.
NEVER USE OTHER KINDS OF GASES.
USE WITH OLYMPUS PRODUCTS.
NEVER CONNECT WITH OTHER UNIT.
Name plate
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HIGH FLOW INSUFFLATION UNIT UHI-3
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Labels and Symbols
CYLINDER HOSE (DIN) FOR UHI-3 (MAJ-1081)
CYLINDER HOSE (ISO) FOR UHI-3 (MAJ-1082)
Name plate
Symbol mark (
)
Refer to instructions.
SUPPLY CO2 GAS FOR MEDICAL USE ONLY.
NEVER USE OTHER KINDS OF GASES.
USE WITH OLYMPUS PRODUCTS.
NEVER CONNECT WITH OTHER UNIT.
Symbol mark (
)
Refer to instructions.
SUPPLY CO2 GAS FOR MEDICAL USE ONLY.
NEVER USE OTHER KINDS OF GASES.
USE WITH OLYMPUS PRODUCTS.
NEVER CONNECT WITH OTHER UNIT.
Name plate
HIGH FLOW INSUFFLATION UNIT UHI-3
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Labels and Symbols
Back cover of this instruction manual
Manufacturer
Authorized representative in the European Community
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HIGH FLOW INSUFFLATION UNIT UHI-3
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Important Information — Please Read Before Use
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 to facilitate laparoscopic observation
and treatment within the abdominal cavity.
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.
HIGH FLOW INSUFFLATION UNIT UHI-3
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Important Information — Please Read Before Use
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 EMC standard for medical electrical equipment;
edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument
that complies with EMC standard for medical electrical equipment; edition 1
(IEC 60601-1-2: 1993), the whole system complies with edition 1.
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.
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Important Information — Please Read Before Use
Signal words
The following signal words are used throughout this manual:
Indicates an imminently hazardous situation 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.
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 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 adaptor for medical gas pipeline as
described in this instruction manual to connect the CO2 gas
cylinder or medical gas pipeline.
HIGH FLOW INSUFFLATION UNIT UHI-3
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Important Information — Please Read Before Use
•
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-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.
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Important Information — Please Read Before Use
•
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 CO2 supply 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 CO2 supply 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
HIGH FLOW INSUFFLATION UNIT UHI-3
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Important Information — Please Read Before Use
•
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 CO2 gas 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 CO2 gas 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
10
•
Excessive flow rates and/or pressures may result in an
excessive absorption of CO2 and/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 CO2 absorption.
HIGH FLOW INSUFFLATION UNIT UHI-3
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Important Information — Please Read Before Use
•
Other possible complications include CO2 embolization,
hypothermia and carbonic acid irritation of the diaphragm.
Direct access of insufflated CO2 gas 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.
•
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.
•
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”.
•
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.
As defined by the international safety standard
(IEC 60601-1), medical electrical equipment is classified into
the following types: Type CF applied part (the instrument can
safely be applied to any part of the body, including the heart),
and Type B/BF applied part (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.
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Important Information — Please Read Before Use
Symbol
Classification
Type CF applied part
Type BF applied part
Type B applied part
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Chapter 1 Checking the Package Contents
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.
High flow insufflation unit (UHI-3)
Tube with green line
Y-shaped connector
Power cord
Small diameter tube
(transparent)
Extension tube
Nut cover
(For European market)
Differential diameter
connector
Small luer-lock
connector
Suction tube (MAJ-591)
Tube
(transparent)
Filter connecting
tube
Large luer-lock connector
Instruction manual
Insufflation tube (MAJ-590)
HIGH FLOW INSUFFLATION UNIT UHI-3
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Chapter 1 Checking the Package Contents
1.2
Optional items
FOOT SWITCH (MH-317)
CYLINDER HOSE (PIN) FOR UHI-3 (MAJ-1080)
Cap
HOSE FOR CYLINDER
Wrench
For European market, the wrench is supplied for installation of the unit by an
Olympus sales representative or service engineer only.
The wrench will be returned to Olympus directly after installation.
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Chapter 1 Checking the Package Contents
CYLINDER HOSE (DIN) FOR UHI-3 (MAJ-1081)
CYLINDER HOSE (ISO) FOR UHI-3 (MAJ-1082)
Cap1
Cap2
Wrench (large)
HOSE FOR CYLINDER
Wrench (small)
For European market, the wrench (small) is supplied for installation of the unit by
an Olympus sales representative or service engineer only.
The wrench (small) will be returned to Olympus directly after installation.
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
For European market, the wrench is supplied for installation of the unit by an
Olympus sales representative or service engineer only.
The wrench will be returned to Olympus directly after installation.
HIGH FLOW INSUFFLATION UNIT UHI-3
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Chapter 2 Instrument Nomenclature
Chapter 2 Instrument Nomenclature
2.1
Symbols and descriptions
Power switch
Power ON/OFF
CO2 INSUFFLATION connector
CO2 SUCTION control pinch valve
CYLINDER PRESSURE
ABDOMINAL PRESSURE section
Abdominal pressure
Warning, excessive pressure
Warning, tube obstructed
Relief mode
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Chapter 2 Instrument Nomenclature
FLOW RATE section
Flow rate
High mode
Medium mode
Low mode
VOLUME section
Total volume used
Reset
START
STOP
FOOTSWITCH connector
CO2 GAS INLET
HIGH FLOW INSUFFLATION UNIT UHI-3
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Chapter 2 Instrument Nomenclature
Others
Alternating current
Circuit breaker
Equipotential terminal
Refer to instructions.
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Chapter 2 Instrument Nomenclature
2.2
Front panel
Front panel
2. Abdominal pressure
control switches
3. Flow mode selector
4. Flow rate control switches
1. POWER switch
7. CO2 insufflation
connector
5. RESET switch
9. START switch
8. STOP switch
HIGH FLOW INSUFFLATION UNIT UHI-3
6. CO2 suction control
pinch valve
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Chapter 2 Instrument Nomenclature
1. POWER switch
This switch is pressed to turn the power ON or OFF.
2. Abdominal pressure control switches
These switches are pressed to set the abdominal pressure. Setting range is
between 3 to 25 mmHg.
3. Flow mode selector
This switch is pressed to select the flow mode (LOW, MED, HIGH).
4. Flow rate control switches
These switches are pressed to set the flow rate.
When LOW is selected, the flow rate can be set within a range of 0.1 to
1.0 L/min.
When MED is selected, the flow rate can be set within a range of 1.1 to
19 L/min.
When HIGH is selected, the flow rate can be set within a range of 20 to
35 L/min.
5. RESET switch
This switch is pressed to reset the VOLUME indicator.
To switch the relief mode, keep pressing this switch for several seconds
after turning on the POWER switch.
6. CO2 suction control pinch valve
This valve is connected with the suction tube.
7. CO2 insufflation connector
This is connected with the insufflation tube or filter connecting tube.
8. STOP switch
This switch is pressed to cancel the active mode
9. START switch
When this switch is pressed, insufflation starts and the unit enters operation
mode, in which smoke evacuation and automatic suction are performed.
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Chapter 2 Instrument Nomenclature
Indicators and functions
4. Warning lamp for excessive pressure
5. Set flow rate indicator
3. Abdominal pressure indicator
2. Set pressure indicator
1. Lamp for relief
mode
6. Actual flow rate indicator
7. Warning lamp for tube
obstruction
8. Volume indicator
15. Power indicator
9. Bar graph for flow rate
14. Lamp for start
13. Lamp for stop
10. Lamp for flow
mode indication
12. Bar graph for supply pressure
11. Bar graph for abdominal pressure
HIGH FLOW INSUFFLATION UNIT UHI-3
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Chapter 2 Instrument Nomenclature
1. Lamp for relief mode
This lamp lights when relief mode is activated.
2. Set pressure indicator
This indicator shows the set pressure in green digits.
3. Abdominal pressure indicator
This indicator shows the abdominal pressure in red digits.
4. Warning lamp for excessive pressure
This lamp lights when abdominal pressure reaches 5 mmHg or more above
the set pressure.
5. Set flow rate indicator
This indicator shows the set flow rate in green digits.
6. Actual flow rate indicator
This indicator shows the actual flow rate in red digits.
7. Warning lamp for tube obstruction
This lamp lights when insufflation tube is blocked or clogged, or when
insufflation is performed into an abnormally narrow cavity.
8. Volume indicator
This indicator shows the volume of gas used.
9. Bar graph for flow rate
This graph shows the current flow rate.
10. Lamp for flow mode indication
These lamps light when the corresponding flow mode is selected.
11. Bar graph for abdominal pressure
Blinking green LEDs shows the set pressure. A green bar shows the
abdominal pressure. If abdominal pressure exceeds the set pressure, the
excess is displayed in red.
12. Bar graph for supply pressure
This bar graph shows the pressure of the connected supply gas. When the
pressure is below 2.5 MPa, the alarm sounds. When the pressure is low and
the CO2 gas is not insufflated, an alarm sounds and a red LED lights.
13. Lamp for stop
This lamp lights when the STOP switch is pressed and indicates that the
stop mode is selected.
14. Lamp for start
This lamp lights when the START switch is pressed and indicates that the
operating mode is active.
15. Power indicator
This indicator lights when the power is ON.
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HIGH FLOW INSUFFLATION UNIT UHI-3