Instructions
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Page 1
INSTRUCTIONS
HIGH FLOW INSUFFLATION UNIT
UHI-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
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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
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
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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
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
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.
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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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HIGH FLOW INSUFFLATION UNIT UHI-3
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.
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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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HIGH FLOW INSUFFLATION UNIT UHI-3
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
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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
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•
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
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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HIGH FLOW INSUFFLATION UNIT UHI-3
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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HIGH FLOW INSUFFLATION UNIT UHI-3
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.
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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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HIGH FLOW INSUFFLATION UNIT UHI-3
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
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