Instructions
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INSTRUCTIONS HIGH FLOW INSUFFLATION UNIT
UHI-4
Contents
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
Instrument Nomenclature ...
25
2.1
Symbols and descriptions ...
25
2.2
Front panel...
28
2.3
Rear panel ...
32
2.4
Optional components ...
34
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
Inspection ...
65
Inspection workflow...
65
Chapter 2
Chapter 3
Chapter 4 4.1
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Contents
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) ..
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
67
4.10 Inspection of UHI-4 operation when using a veress needle/trocar/port device for transanal access... 73 4.11 Power OFF...
Chapter 5
73
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
ii
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
HIGH FLOW INSUFFLATION UNIT UHI-4
Contents
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...
Chapter 7
133
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
HIGH FLOW INSUFFLATION UNIT UHI-4
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Contents
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HIGH FLOW INSUFFLATION UNIT UHI-4
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.
HIGH FLOW INSUFFLATION UNIT (UHI-4)
Electrical rating plate MEDICAL DEVICE HIGH FLOW INSUFFLATION UNIT MODEL: UHI-4 POWER INPUT: 100-240V~ 50/60Hz 110VA Instruction manual reference mark
CSA marking CE marking Crossed-out wheeled bin’ symbol
Authorized representative in the European Community
Potential equalization terminal
Serial number plate Date of manufacture
Maximum supply pressure rating 16.2MPa
Fuse rating
CO2 gas inlet Serial number
Manufacturer
HIGH FLOW INSUFFLATION UNIT UHI-4
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Labels and Symbols
Front panel
UDI label The UDI label is required by some countries’ regulations regarding the identification of a medical device also known as Unique Device Identification (UDI).
2
HIGH FLOW INSUFFLATION UNIT UHI-4
Labels and Symbols
CYLINDER HOSE (PIN) FOR UHI-3 (MAJ-1080)
Name plate
Caution
Name plate
HIGH FLOW INSUFFLATION UNIT UHI-4
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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
Caution
SUPPLY CO2 GAS FOR MEDICAL USE ONLY. NEVER USE OTHER KINDS OF GASES. USE WITH OLYMPUS PRODUCTS. NEVER CONNECT WITH OTHER UNIT.
Caution
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-4
Labels and Symbols
Back cover of this instruction manual Manufacturer
Authorized representative in the European Community Translation Importer (into European Union)
HIGH FLOW INSUFFLATION UNIT UHI-4
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Labels and Symbols
6
HIGH FLOW INSUFFLATION UNIT UHI-4
Important Information - Please Read Before Use
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.
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Important Information - Please Read Before Use
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.
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HIGH FLOW INSUFFLATION UNIT UHI-4
Important Information - Please Read Before Use
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.
HIGH FLOW INSUFFLATION UNIT UHI-4
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Important Information - Please Read Before Use
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.
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HIGH FLOW INSUFFLATION UNIT UHI-4
Important Information - Please Read Before Use
•
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.
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Important Information - Please Read Before Use
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.
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•
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.
HIGH FLOW INSUFFLATION UNIT UHI-4
Important Information - Please Read Before Use
•
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.
HIGH FLOW INSUFFLATION UNIT UHI-4
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Important Information - Please Read Before Use
•
To avoid complications, monitor patient parameters such as endotidal CO2, electrocardiogram, body temperature, etc. while using the UHI-4. – 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.
•
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
•
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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.
HIGH FLOW INSUFFLATION UNIT UHI-4
Important Information - Please Read Before Use
•
Idiosyncratic reactions. Patients with sickle cell disease or pulmonary insufficiency may have an increased risk of metabolic imbalance related to excessive CO2 absorption.
•
Other possible complications include CO2 embolization, hypothermia, and carbonic acid irritation of the diaphragm. Direct access of insufflated CO2 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.
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When using the two high flow insufflation units simultaneously on a single region of a single patient, make sure to set an identical pressure to the two insufflators.
•
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.
•
In endoscopic procedures which use gas insufflation, venous gas embolism is a very rare (approximately 1 in 10,000 cases) but potentially serious complication that may occur. Its occurrence is signaled by cardiovascular collapse (sudden, severe hypotension), and a precordial murmur. If gas embolism is observed during a procedure, discontinue gas insufflation and place the patient in a left lateral and a slight Trendelenburg position.
•
Use of ACCESSORIES, transducers and cables other than those specified in this manual above may not comply with EMC.
•
EQUIPMENT or SYSTEM should not be used adjacent to or stacked with other equipment to avoid the influence of EMC.
•
Use of the ACCESSORY, transducer or cable with ME EQUIPMENT and ME SYSTEMS other than those specified in this manual may result in increased EMISSIONS or decreased IMMUNITY of the EQUIPMENT or SYSTEM.
•
Do not supply gas for a long time without connecting the insufflation tube to the patient. The pressure reducer may structurally freeze, resulting in inability of the functions including insufflation.
•
Use only the port device for transanal access to insufflate the colon.
HIGH FLOW INSUFFLATION UNIT UHI-4
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