Instructions
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INSTRUCTIONS
HIGH FLOW INSUFFLATION UNIT
UHI-2
0197
Manufactured by 2951 Ishikawa-cho, Hachioji-shi, Tokyo 192-8507, Japan Fax: (0426)46-2429 Telephone: (0426)42-2111
Distributed by (Premises/Goods delivery) Wendenstrasse 14-18, D-20097 Hamburg, Germany (Letters) Postfach 10 49 08, D-20034 Hamburg, Germany Telephone: (040)237730
Kuehnstrasse 61, D-22045 Hamburg, Germany Fax: (040)6681591 Telephone: (040)669660
Two Corporate Center Drive, Melville, N.Y. 11747-3157, U.S.A. Fax: (631)844-5442 Telephone: (631)844-5000
KeyMed House, Stock Road, Southend-on-Sea, Essex SS2 5QH, United Kingdom Telex: 995283 Fax: (01702)465677 Telephone: (01702)616333
491B, River Valley Road #12-01/04, Valley Point Office Tower, Singapore 248373 Fax: 6834-2438 Telephone: 6834-0010
Room 1401, East Tower, GongYuan No.6 Royal Palace, No.6 GongYuanXiJie, Jian Guo Men Nei, DongCheng District, Beijing, 100005, China Fax: (10)6518-0865 Telephone: (10)6518-8080
117071, Moscow, Malaya Kaluzhskaya 19, bld. 1, fl.2, Russia Fax: (095)958-2277 Telephone: (095)958-2245
31 Gilby Road, Mount Waverley, VIC., 3149, Australia Fax: (03)9543-1350 Telephone: (03)9265-5400
6100 Blue Lagoon Drive, Suite 390 Miami, FL 33126-2087, U.S.A. Fax: (305)261-4421 Telephone: (305)266-2332
GC5417 07
Printed in Japan 20031001 :0000
Contents
Contents Labels and Symbols Important Information- Please Read Before Use Intended Use...
4
Instruction Manual...
4
User Qualifications...
4
Instrument Compatibility...
5
Reprocessing and Storage...
5
Repair and Modification...
5
Signal Words...
6
Dangers, Warnings and Cautions...
6
Chapter 1
Checking the Package Contents
1.1
Checking the Package Contents...
11
1.2
Optional Items...
12
Chapter 2
Instrument Nomenclature
2.1
Symbols and Descriptions...
14
2.2
Front Panel...
17
2.3
Rear and Side Panels...
21
2.4
Optional Components...
22
Chapter 3
Installation and Connection
3.1
Installation of UHI-2 Main Unit...
24
3.2
Connecting to an AC Mains Supply...
25
3.3
Connecting a CO2 Gas Cylinder...
26
3.4
Connecting the Medical Gas Pipeline (Optional Adaptor for Medical Gas Pipeline [MAJ-626/627] Required)...
28
3.5
Connecting the Foot Switch (MH-317)...
29
3.6
Connecting the Aeration Unit (MAJ-529)...
30
3.7
Assembling the Insufflation Tube and Suction Tube...
32
HIGH FLOW INSUFFLATION UNIT UHI-2
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Contents
Chapter 4
Inspection
4.1
Inspection of UHI-2 Main Unit...
36
4.2
Inspection of Hose For Cylinder...
38
4.3
Inspection of Adaptor for Medical Gas Pipeline (MAJ-626/627) . . .
39
4.4
Inspection of the Foot Switch (MH-317)...
39
4.5
Inspection of the Insufflation Tube and Suction Tube...
39
4.6
Inspection of UHI-2 Operation When Using a Veress Needle/Trocar
40
Chapter 5
Operation
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)...
48
5.6
Aeration Interlock With UES-20, UES-30 and/or SonoSurg-G (Aeration Unit [MAJ-529] Required)...
50
5.7
Resetting the CO2 Gas Volume Indicator...
50
5.8
After Use...
51
Chapter 6
Care and Storage
6.1
General Policy...
53
6.2
Precautions...
53
6.3
Compatible Reprocessing Methods and Chemical Agents...
54
6.4
Cleaning of UHI-2 main body, Foot Switch, Hose For Cylinder and Adaptor For Medical Gas Pipeline...
6.5
Storage of the UHI-2 main body, Foot Switch, Hose For Cylinder and Adaptor For Medical Gas Pipeline...
6.6
55 56
Cleaning Prior to Sterilization of the Insufflation Tube and Suction Tube...
57
6.7
Sterilization of the Insufflation Tube and Suction Tube...
58
6.8
Storage of Insufflation Tube, Suction Tube and Luer-lock Connector 58
Chapter 7
Troubleshooting
7.1
Troubleshooting Guide...
59
7.2
Alarm Functions...
62
7.3
Returning the High Flow Insufflation Unit for Repair...
64
System Chart...
65
Specifications...
68
Appendix
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HIGH FLOW INSUFFLATION UNIT UHI-2
Labels and Symbols
Labels and Symbols Safety-related labels are attached to the instrument at the locations shown below. If labels are missing or illegible, contact Olympus.
` UHI-2 Main Unit
Electrical Rating Plate Product name, rated voltage, and serial number.
Symbol mark (
)
Refer to instructions.
Rear Side
HIGH FLOW INSUFFLATION UNIT UHI-2
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Labels and Symbols
HIGH FLOW INSUFFLATION UNIT MODEL UHI-2 INPUT 220-240V~ 0.4A 50/60Hz SN OLYMPUS CORPORATION MADE IN JAPAN
Electrical Rating Plate
2
HIGH FLOW INSUFFLATION UNIT UHI-2
Labels and Symbols
` HOSE FOR CYLINDER (PIN) (MAJ-622)
Name Plate
Symbol mark (
)
Refer to instructions.
0197 DANGER J SUPPLY CO2 GAS FOR MEDICAL USE ONLY. NEVER USE OTHER KINDS OF GASES. J USE WITH HIGH FLOW INSUFFLATION UNIT (UHI-2). NEVER CONNECT WITH ANOTHER UNIT. Name Plate
` HOSE FOR CYLINDER (DIN) (MAJ-623) HOSE FOR CYLINDER (ISO) (MAJ-624) Name Plate
Symbol mark (
)
0197
Refer to instructions.
DANGER J SUPPLY CO2 GAS FOR MEDICAL USE ONLY. NEVER USE OTHER KINDS OF GASES. J USE WITH HIGH FLOW INSUFFLATION UNIT (UHI-2). NEVER CONNECT WITH ANOTHER UNIT. Name Plate
HIGH FLOW INSUFFLATION UNIT UHI-2
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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 clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures.
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HIGH FLOW INSUFFLATION UNIT UHI-2
Important Information--Please Read Before Use
Instrument Compatibility Refer to the “System Chart” in Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury 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 in Chapter 6, “Care and Storage”. After using this instrument, reprocess and store it according to the instructions 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. Problems that appear not 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.
HIGH FLOW INSUFFLATION UNIT UHI-2
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Important Information--Please Read Before Use
Signal Words The following signal words are used throughout this manual: DANGER
Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.
WARNING
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
CAUTION
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.
NOTE
Indicates additional helpful information.
Dangers, Warnings and Cautions Follow the dangers, warnings and cautions described below when handling this instrument. This information is supplemented by the dangers, warnings and cautions described in each chapter. DANGER
S The UHI-2 is not explosion-proof. Never install or operate it in the presence of flammable gases. S 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 hose for cylinder or Adaptor for Medical Gas Pipeline as listed in this instruction manual to connect the CO2 gas cylinder or Medical Gas Pipeline.
WARNING
S 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 under gravity. S Always keep the gas cylinder in the upright position. Fasten the cylinder 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-2 and normal insufflation may become impossible.
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HIGH FLOW INSUFFLATION UNIT UHI-2
Important Information--Please Read Before Use
S 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. -- In the event of combined use of an insufflator and a laser device, argon-enhanced coagulator or other gas supply devices, when performing laparoscopy, both instruments become a source of supply for gas. Accordingly, the determined amount of pressure in the abdomen is reached in a shorter time than when solely using the pneumoperitoneurn device. Be careful that the intra-abdomen does not become over-pressurized. The laser device argon-enhanced coagulator, and other gas supply devices are not equipped with functions 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. -- If the insufflator emits a warning (warning light or alarm) for intra-abdominal over-pressurization, quickly open the stopcock or valve of the trocar. In this event, reduce the amount of outflow from the laser device, argon-enhanced coagulator, or other gas supply device. If use is continued while the alarm is sounding, there is a risk of gas embolism due to intra-abdominal over-pressurization. S When Relief Mode is set to ON, the intra-abdominal gas will flow backward into the equipment for relief through the built-in valve into the equipment. To prevent the internal surfaces of the equipment from being contaminated, be sure to use a Disposable Filter. When no filter is used, make sure Relief Mode is set to OFF.
HIGH FLOW INSUFFLATION UNIT UHI-2
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Important Information--Please Read Before Use
S Use the Disposable Filter when the Relief Mode is activated to prevent cross-contamination from the backflow of body fluids (e.g. blood). Olympus recommends using filter TYPE PALL ORO1H (0.2 µm, hydrophobic), or contact Olympus for further details. Olympus highly recommends using a Disposable Filter when the Relief Mode is not activated. S To reduce the risk of electric shock, do not remove cover. S To prevent operator shock and instrument damage, keep liquids away from all electrical equipment. If fluid enters the UHI-2, stop operation immediately and contact Olympus. S The UHI-2 is for use in medical facilities under the supervision of a trained physician. Do not use under any other conditions. S Always use the UHI-2 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. S To prevent electrical shock hazards, the housing of the UHI-2 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
S Prepare spare CO2 gas cylinders for quick replacement if the cylinder used during the procedure should run out. S To ensure that the operation can be completed without complication in the case of a malfunction, prepare a spare UHI-2 unit as a backup.
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HIGH FLOW INSUFFLATION UNIT UHI-2
Important Information--Please Read Before Use
S 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. S Only use the UHI-2 as described in “Operating Environment” in “Specifications” contained in “Appendix”. Use under other conditions may not only impair normal performance, but may also result in equipment breakdown. S 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-2. Should any fluids enter the UHI-2, immediately terminate its use and contact Olympus. S To avoid complications, monitoring of the patient’s parameters such as endotidal CO2, electrocardiogram, body temperature, etc., during use of UHI-2. And take appropriate measures. S 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 S Excessive flow rates and/or excessive pressures may result in an excessive absorption of CO 2 and/or gas embolism. The abdomen can be adequately distended by 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 respirations helps avoid problems related to CO2. S Idiosyncratic reactions. Patients with sickle cell disease or pulmonary insufficiency may have an increased risks of metabolic imbalance related to excessive CO2 absorption.
HIGH FLOW INSUFFLATION UNIT UHI-2
9
Important Information--Please Read Before Use
S 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. S Use of this device for intra-abdominal distention is contraindicated whenever laparoscopy is contraindicated. S This device is contraindicated for hysteroscopic insufflation, i.e., it must not be used for intrauterine distention. CAUTION
S This instrument contains no user serviceable parts. Repairs should be performed only by Olympus. S Before using a Veress needle and trocar, inspect the items as outlined in Section 4.6, “Inspection of UHI-2 Operation When Using a Veress Needle/Trocar”.
NOTE
As defined by the international safety standard (IEC60601-1), 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. Symbol
Classification Type CF applied part
Type BF applied part
Type B applied part
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HIGH FLOW INSUFFLATION UNIT UHI-2
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 instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in Chapter 6.
High Flow Insufflation Unit (UHI-2)
Tube with green line
Small Diameter Tube (transparent)
Differential Diameter Connector
Y-shaped Connector
Extension Tube
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-2
11
Chapter 1 Checking the Package Contents
1.2
Optional Items ` FOOT SWITCH (MH-317)
` HOSE FOR CYLINDER (PIN) (MAJ-622)
Cap
Wrench
HOSE FOR CYLINDER
` HOSE FOR CYLINDER (DIN) (MAJ-623) HOSE FOR CYLINDER (ISO) (MAJ-624)
Cap1
Cap2
Wrench (large)
HOSE FOR CYLINDER
12
HIGH FLOW INSUFFLATION UNIT UHI-2
Wrench (small)
Chapter 1 Checking the Package Contents
` ADAPTER FOR MEDICAL GAS PIPELINE (NIST) (MAJ-626) ADAPTER FOR MEDICAL GAS PIPELINE (DISS) (MAJ-627)
ADAPTOR FOR MEDICAL GAS PIPELINE
HIGH FLOW INSUFFLATION UNIT UHI-2
Wrench
13
Chapter 2 Instrument Nomenclature
Chapter 2 Instrument Nomenclature 2.1
Symbols and Descriptions ` Power Switch 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-2
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-2
15
Chapter 2 Instrument Nomenclature
` Others Alternating Current Circuit breaker Equipotential Terminal Refer to Instructions.
16
HIGH FLOW INSUFFLATION UNIT UHI-2