Instructions
230 Pages
Preview
Page 1
INSTRUCTIONS
ENDOSCOPE POSITION DETECTING UNIT
UPD-3
Connection and use of this communications equipment is permitted by the Nigerian Communications Commission
USA: CAUTION: Federal law restricts this device to sale by or on the order of a physician. (For EU model)
Contents
Contents Labels and Symbols ...
1
Important Information - Please Read Before Use...
9
Intended use ...
9
Indication for use ...
9
Instruction manual ...
9
User qualifications...
11
Instrument compatibility ...
11
Repair and modification ...
11
Signal words...
12
Dangers, warnings, and cautions ...
12
Summary of Equipment Functions ...
16
Chapter 1
Package Contents ...
17
1.1
Endoscope position detecting unit (UPD-3) ...
18
1.2
Receiver dish stand (MAJ-1907) (Optional for B set) ...
22
1.3
Receiver dish (MAJ-1868) (Optional for B set) ...
23
1.4
Hand coil (MAJ-1859) (Optional for B set) ...
23
1.5
Reference plate (MAJ-1860) (Optional) ...
23
1.6
Remote control (MAJ-1890) (Optional) ...
24
1.7
Hand coil cover (MAJ-1879) (Optional)...
24
1.8
Reference plate cover (MAJ-1880) (Optional, Single use) ...
25
1.9
Reference plate belt (MAJ-1029) (Optional) ...
25
1.10 Connection unit (MAJ-1928) (Optional) ...
25
1.11 UPD cable (MAJ-1881) ...
26
1.12 CLV-UPD cable (MAJ-1898)...
26
1.13 Receiver dish cable (MAJ-1875, MAJ-1927) (MAJ-1927 is Optional) ...
26
1.14 Extension cable for RC (MAJ-1929, MAJ-1931) (Optional) ...
27
1.15 Extension cable for HC-RP (MAJ-1930, MAJ-1932) (Optional) ...
27
1.16 Unified cable (MAJ-1964) (Optional)...
27
1.17 Receiver dish arm (MAJ-1962) (Optional) ...
28
1.18 Holder for HC-RP (MAJ-1938) (Optional) ...
28
1.19 Receiver dish stand supplementary set (MAJ-1978) (Optional) ...
29
1.20 Water-resistant cap (MAJ-1899) (Optional) ...
29
1.21 Seal ring (MAJ-1963) (Optional) ...
30
Endoscope Position Detecting Unit UPD-3
i
Contents
Chapter 2
Nomenclature and Functions ...
31
2.1
Symbols and descriptions ...
31
2.2
Main unit ...
32
2.3
Receiver dish (MAJ-1868)...
36
2.4
Receiver dish stand (MAJ-1907)...
37
2.5
UPD cable (MAJ-1881) ...
38
2.6
Hand coil (MAJ-1859) ...
38
2.7
Reference plate (MAJ-1860) ...
39
2.8
Reference plate cover (MAJ-1880) ...
39
2.9
Remote control (MAJ-1890) ...
40
2.10 Connection unit (MAJ-1928) ...
42
2.11 Screen display ...
43
Chapter 3
Installation and Connection...
48
3.1
Installation work flow ...
49
3.2
Installation of the equipment ...
50
3.3
Installation of the receiver dish (MAJ-1868)...
52
3.4
Installation of the receiver dish accessories...
61
3.5
Connection of the receiver dish (MAJ-1868)...
74
3.6
XGA monitor ...
78
3.7
Videocassette recorder, Video printer...
79
3.8
OEV261H ...
80
3.9
Connection of the UPD cable (MAJ-1881) ...
81
3.10 Connection of the connection unit (MAJ-1928) ...
82
3.11 Remote control (MAJ-1890) ...
87
3.12 Connection of EVIS 190/290 system ...
89
3.13 Video system center (except for CV-190,CV-290) ...
93
3.14 Connection to an AC mains power supply ...
98
Chapter 4
ii
Settings... 101
4.1
Basic operation of the menu ...
101
4.2
System setup ...
105
4.3
User presets...
113
4.4
Adjustment ...
131
Endoscope Position Detecting Unit UPD-3
Contents
Chapter 5
Inspection ... 134
5.1
Inspection work flow...
135
5.2
Inspection of the installation location of the receiver dish stand (MAJ-1907) ...
136
5.3
Adjusting the position of the receiver dish (MAJ-1868)...
136
5.4
Connection of EVIS 190/290 series endoscope ...
139
5.5
Connection of the endoscope (except for EVIS 190/290 series) or the position detecting probe...
140
5.6
Turning power ON...
142
5.7
Endoscope model display range...
144
5.8
Inspection of the display screen...
149
5.9
Inspection of the hand coil (MAJ-1859) ...
150
5.10 Inspection of the reference plate (MAJ-1860)...
150
5.11 Power OFF...
150
Chapter 6
Operation ... 151
6.1
Operation flow...
154
6.2
Turning power ON...
156
6.3
Starting the endoscopic examination ...
157
6.4
Displaying the endoscope model ...
158
6.5
Operation at the end of an examination...
161
Chapter 7
Functions ... 163
7.1
Rotating the endoscope model ...
163
7.2
Changing the size of the endoscope model...
165
7.3
Split Screen...
167
7.4
Reset current screen...
169
7.5
Bookmark...
170
7.6
Setting the endoscope model display range ...
172
7.7
Connecting the hand coil (MAJ-1859)...
176
7.8
Vantage point...
179
7.9
Connecting the reference plate (MAJ-1860) ...
180
7.10 Attaching the reference plate (MAJ-1860) to the patient’s body ...
182
7.11 Using the remote control (MAJ-1890) ...
187
Endoscope Position Detecting Unit UPD-3
iii
Contents
Chapter 8 8.1
Care, Storage, and Disposal ... 188 Care of the main unit and accessories of the endoscope position detecting unit...
189
8.2
Cleaning procedures for accessories...
190
8.3
Changing the seal ring (MAJ-1963) ...
194
8.4
Changing the water-resistant cap (MAJ-1899)...
195
8.5
Storage ...
196
8.6
Disposal ...
196
Chapter 9
Troubleshooting ... 197
9.1
Troubleshooting guide ...
198
9.2
Returning the endoscope position detecting unit (UPD-3) for repair...
203
Appendix... 205
iv
System chart ...
205
Transportation, storage, and operation environment ...
208
Specifications ...
209
EMC information...
216
Endoscope Position Detecting Unit UPD-3
Labels and Symbols
Labels and Symbols Safety-related labels and symbols are attached on the locations shown below. If labels or symbols are missing or illegible, contact Olympus.
Main unit (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).
Endoscope Position Detecting Unit UPD-3
1
Labels and Symbols
Main unit (for USA model)
Blue
Refer to instructions.
KC marking
Serial number plate
NCC marking
Date of manufacture
This instrument emits RF (Radio Frequency) energy to perform intended functions.
Serial number
Product name and electric rating
FCC statement
CSA/UL marking
ENDOSCOPE POSITION DETECTING UNIT MODEL UPD-3 POWER INPUT 100 – 240 V 50/60 Hz 110 VA TV type (NTSC)
Manufacturer
FCC ID and IC ID
2
Endoscope Position Detecting Unit UPD-3
Potential equalization terminal
Labels and Symbols
Main unit (for EU model) TRA-LABEL Nigeria, U.A.E. Serial number plate
KC marking Blue
Refer to instructions. Date of manufacture NCC marking OMAN-TRA Approval number Dealer number
Serial number
Authorized representative in the European Community
This instrument emits RF (Radio Frequency) energy to perform intended functions.
Product name and electric rating MEDICAL DEVICE ENDOSCOPE POSITION DETECTING UNIT MODEL UPD-3 POWER INPUT 100 – 240 V 50/60 Hz 110 VA CE marking
TV type (PAL)
IMDA label
Manufacturer
Potential equalization terminal
R-NZ R-NZ marking
RCM marking
Endoscope Position Detecting Unit UPD-3
Crossed-out wheeled bin’ symbol
3
Labels and Symbols
Receiver dish (MAJ-1868)
CE marking (rear side) Avoid exerting excessive pressure here, otherwise the stand may topple.
Serial number (rear side)
Crossed-out wheeled bin’ symbol (rear side)
Hand coil (MAJ-1859) and water-resistant cap (MAJ-1899)
CE marking
CE marking Serial number (rear side)
TYPE BF applied part Crossed-out wheeled bin’ symbol (rear side)
Reference plate (MAJ-1860) and water-resistant cap (MAJ-1899)
CE marking
CE marking (rear side)
Serial number (rear side)
TYPE BF applied part
4
Endoscope Position Detecting Unit UPD-3
Crossed-out wheeled bin’ symbol (rear side)
Labels and Symbols
Remote control (MAJ-1890)
Serial number (rear side)
CE marking (rear side)
Crossed-out wheeled bin’ symbol (rear side)
Hand coil cover (MAJ-1879)
CE marking
Connection unit (MAJ-1928)
Refer to instructions.
Serial number CE marking
Crossed-out wheeled bin’ symbol
Remote control (MAJ-1890) terminal
Endoscope Position Detecting Unit UPD-3
Hand coil (MAJ-1859) Reference plate (MAJ-1860) terminal
5
Labels and Symbols
Receiver dish stand (MAJ-1907)
CE marking
Serial number
UPD cable (MAJ-1881)
Refer to instructions. CE marking
Scope connector
CLV-UPD cable(MAJ-1898)
Refer to instructions.
CE marking
Receiver dish cable (MAJ-1875, MAJ-1927)
CE marking
6
Endoscope Position Detecting Unit UPD-3
Labels and Symbols
Extension cable for RC (MAJ-1929, MAJ-1931)
CE marking
Extension cable for HC-RP (MAJ-1930, MAJ-1932)
CE marking
Unified cable (MAJ-1964)
CE marking
Receiver dish arm (MAJ-1962)
CE marking
Serial number
Endoscope Position Detecting Unit UPD-3
7
Labels and Symbols
Holder for HC-RP (MAJ-1938)
CE marking
Back cover of this instruction manual Manufacturer
Authorized representative in the European Community
The package of the reference plate cover (MAJ-1880) Single use only
Use by (expiration date)
Non-sterile
CE marking
Refer to instructions
8
Endoscope Position Detecting Unit UPD-3
Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended use This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient. Do not use this instrument for any purpose other than its intended use.
Indication for use This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient. <Patient population> Patients who require colonoscopy and enteroscopy except as follows: •
Patients with a critical active implantable device such as a pacemaker and an implantable cardioverter defibrillator.
•
Pregnant women.
Instruction manual This instruction manual contains essential information on using the endoscope position detecting unit 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 equipment 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.
Endoscope Position Detecting Unit UPD-3
9
Important Information - Please Read Before Use
Terms used in this manual Main unit: The main unit contains electrical circuits and the power supply of the endoscope position detecting unit. Endoscope position detecting unit: The endoscope position detecting unit is the whole system including the main unit, the receiver dish and other accessories.
Main unit
Receiver dish and other accessories
Wall mains outlet: The wall mains outlet is a wall AC mains power outlet socket having the exclusive terminal for grounding. Isolation transformer: The isolation transformer is a safety device that is used to isolate noninsulated equipment with potentially high leakage currents to decrease the possibility of electric shock. Endoscope model: The endoscope model is a computer graphic image that models the shape of the endoscope insertion tube.
10
Endoscope Position Detecting Unit UPD-3
Important Information - Please Read Before Use
User qualifications If there is an official standard on user qualifications to perform endoscopy and endoscopic treatment that is defined by the medical administration or other official institutions, such as academic societies on endoscopy, follow that standard. If there is no official qualification standard, the operator of this instrument must be a physician approved by the medical safety manager of the hospital or person in charge of the department (department of internal medicine, etc.). The physician should be capable of safely performing the planned endoscopy and endoscopic treatment following guidelines set by the academic societies on endoscopy, etc., and considering the difficulty of endoscopy and endoscopic treatment. This manual does not explain or discuss endoscopic procedures.
Instrument compatibility Refer to the “System chart” in the Appendix to confirm that the endoscope position detecting unit is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury and/or equipment damage. Also review the manuals of all equipment that will be used during the procedure and use the equipment as instructed. 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.
Repair and modification The endoscope position detecting unit does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or operator injury, equipment damage and/or the impossibility to obtain the expected functionality can result. Some problems that appear to be malfunctions may be correctable by referring to Chapter 9, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 9, contact Olympus. This instrument is to be repaired by Olympus technicians only.
Endoscope Position Detecting Unit UPD-3
11
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 and cautions given below when handling the endoscope position detecting unit. This information is to be supplemented by the dangers and cautions given in each chapter.
•
As a TYPE BF applied part, the endoscope connected to this instrument must never be applied directly to the heart. Leakage current from the TYPE BF applied part may be dangerous and cause ventricular fibrillation or otherwise seriously affect the cardiac function of the patient. Accordingly, always adhere to the following: Never apply the endoscope connected to this instrument to the heart or any area near the heart. Never allow an EndoTherapy accessory or another endoscope applied to or near the heart to come in contact with the endoscope connected to this instrument.
12
Endoscope Position Detecting Unit UPD-3
Important Information - Please Read Before Use
•
Strictly observe the following precautions. Failure to do so may place the patient and medical personnel in danger of electric shock. When the endoscope position detecting 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 unit, stop operation of the endoscope position detecting unit immediately and contact Olympus. Do not prepare, inspect or use the endoscope position detecting unit with wet hands.
•
Never install and operate the endoscope position detecting unit in locations where: the concentration of oxygen is high. oxidizing agents (such as nitrous oxide (N2O)) are present in the atmosphere. flammable anesthetics are present in the atmosphere. flammable liquids are near. Otherwise, explosion or fire may result because this endoscope position detecting unit is not explosion-proof.
•
The endoscope position detecting unit generates AC magnetic fields. To prevent critical effects on patients, be sure to adhere to the following: Never use the endoscope position detecting unit on a patient with a critical active implantable device such as a pacemaker and an implantable cardioverter defibrillator. The AC magnetic fields generated by the endoscope position detecting unit may cause malfunction or damage to these devices, exerting critical effects to the patient. Never use the endoscope position detecting unit on pregnant women. Never use the endoscope position detecting unit close to pregnant women. The effects of the AC magnetic field generated by the endoscope position detecting unit on the unborn baby have not yet been determined.
Endoscope Position Detecting Unit UPD-3
13
Important Information - Please Read Before Use
14
•
Never insert anything into the ventilation grills of the endoscope position detecting unit. It can cause an electric shock and/or fire.
•
The endoscope position detecting unit may interfere with other medical electronic equipment used in combination with it. Before use, refer to the Appendix to confirm the compatibility of the endoscope position detecting unit with all equipment to be used.
•
Do not use the endoscope position detecting unit in locations exposed to strong electromagnetic radiation (for example, in the vicinity of a microwave therapeutic device, MRI, wireless set, short-wave therapeutic device, cellular/portable phone, etc.). This may impair the performance of the endoscope position detecting unit.
•
Be sure that this instrument is not used adjacent to or stacked with other equipment (other than the components of this instrument or system) to avoid electromagnetic interference.
•
This instrument emits RF (Radio Frequency) energy to perform intended functions. Therefore, it may cause electromagnetic interference in nearby electronic equipment, and is labeled with the following symbol. If electromagnetic interference occurs, mitigation measures may be necessary, such as moving the electronic equipment away, reorienting or relocating this instrument, or shielding the location.
•
Do not touch the electrical contacts inside the endoscope position detecting unit’s connectors. Otherwise, equipment damage and/or malfunction can occur.
•
Do not simultaneously touch any of the exposed electrical contact pins and the patient. It may pose a risk of electric shock to the patient and/or user.
•
Do not use a pointed or hard object to press the buttons on the front panel and/or remote control. This may damage the buttons.
•
Do not apply excessive force to the connectors. Otherwise, a failure of an electrical contact may result in a malfunction.
Endoscope Position Detecting Unit UPD-3
Important Information - Please Read Before Use
•
Turn the endoscope position detecting unit OFF before connecting or disconnecting cables. Equipment damage or malfunction can result.
•
Clean and vacuum dust the ventilation grills using a vacuum cleaner, when necessary. Otherwise, the endoscope position detecting unit may break down and get damaged from overheating.
•
Do not allow the patient to hold the receiver dish or receiver dish stand. Otherwise, the stand may be toppled, and patient injury may result.
•
Do not position the medical device so that it is difficult to disconnect it from the wall outlet (mains power supply).
•
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). The part of the body that an endoscope or electrosurgical accessory can safely be applied to depends on the classification of the equipment to which the instruments are connected. Before beginning the procedure, check the current leakage classification type of each instrument to be used for the procedure. Classification types are clearly specified in the instrument’s instruction manuals. Symbol
Classification TYPE CF applied part
TYPE BF applied part
TYPE B applied part
•
When endoscopes are used with endoscope accessories connected with other medical electronic equipment, the leakage currents may increase.
Endoscope Position Detecting Unit UPD-3
15