Instructions
64 Pages
Preview
Page 1
INSTRUCTIONS
HD CAMERA HEAD
OTV-S7ProH-HD-L08E
For PAL Type equipment
Contents
Contents
HD CAMERA HEAD OTV-S7ProH-HD-L08E
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Contents
Labels and Symbols ...
1
Important Information - Please Read Before Use...
3
Intended use ...
3
Instruction manual ...
3
User qualifications ...
3
Instrument compatibility...
4
Reprocessing and storage ...
4
Repair and modification ...
4
Spare equipment ...
5
Signal words ...
5
Dangers and warnings ...
6
Cardiac applications ...
7
Precautions against frozen or lost endoscopic images ...
8
Chapter 1
Checking the Package Contents ...
10
Chapter 2
Nomenclature and Functions ...
11
Chapter 3
Preparation and Inspection ...
13
3.1
Endoscope selection ...
13
3.2
Inspection of the camera head...
14
3.3
Preparation of ancillary equipment...
14
3.4
Connecting and disconnecting the camera head to the video system center 15
3.5
Connecting and disconnecting the endoscope ...
17
Operation...
19
4.1
Focus adjustment...
22
4.2
Positioning the endoscopic image...
23
4.3
Color adjustment ...
24
4.4
Setting the brightness ...
24
4.5
Observation of the NBI image ...
25
4.6
Setting the remote control switches ...
26
Reprocessing: General Policy...
27
5.1
Instructions...
27
5.2
Notes for cleaning, disinfection, and sterilization ...
27
5.3
Precautions ...
28
Chapter 4
Chapter 5
Chapter 6 ii
Compatible Reprocessing Methods and Chemical
HD CAMERA HEAD OTV-S7ProH-HD-L08E
Contents
Agents ...30 6.1
Compatibility summary...
30
6.2
Detergent solution...
32
6.3
Disinfectant solution...
33
6.4
Rinsing water ...
33
6.5
Ethylene oxide gas sterilization...
34
Chapter 7
Cleaning, Disinfection, and Sterilization Procedures 35
7.1
Required reprocessing equipment ...
35
7.2
Cleaning, disinfection, and sterilization procedures...
36
7.3
Precleaning ...
37
7.4
Manual cleaning...
38
7.5
High-level disinfection ...
39
7.6
Rinsing after high-level disinfection ...
40
7.7
Sterilization ...
41
Care, Storage, and Disposal...
42
8.1
Wiping the surface and cover glass ...
42
8.2
Storage ...
44
8.3
Disposal ...
44
Troubleshooting ...
45
Returning the camera head for repair ...
45
Appendix ...
47
System chart ...
47
Operating environment ...
50
Transportation and storage environment ...
50
Specifications ...
50
EMC information ...
52
Chapter 8
Chapter 9
HD CAMERA HEAD OTV-S7ProH-HD-L08E
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Contents
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HD CAMERA HEAD OTV-S7ProH-HD-L08E
Labels and Symbols
Labels and Symbols Safety-related labels and symbols are attached to the camera head at the locations shown below. If labels or symbols are missing or illegible, contact Olympus. Caution, refer to instructions. Type BF applied part.
Caution indication Caution see below
Model name plate Model name
HD CAMERA HEAD OTV-S7ProH-HD-L08E
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Labels and Symbols
Caution indication
Model name plate
Back cover of this instruction manual Manufacturer
Authorized representative in the European Community
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HD CAMERA HEAD OTV-S7ProH-HD-L08E
Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended use This camera head has been designed to be used with the CV-180 EVIS EXERA II video system center or OTV-S7Pro VISERA Pro video system center1, endoscope, light source, monitor, and other ancillary equipment for endoscopic observation, diagnosis and treatment. Do not use this camera head for any purpose other than its intended use. 1 This product is not available in some areas.
Instruction manual This instruction manual contains essential information on using this camera head safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment that 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.
User qualifications This manual does not explain or discuss clinical endoscopic procedures. Therefore, 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.
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Important Information - Please Read Before Use
Instrument compatibility Refer to the “System chart” in the Appendix to confirm that this camera head 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 equipment, edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument that complies with the EMC standard for medical equipment, edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.
Reprocessing and storage This camera head was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”. After using this instrument, reprocess and store it according to the instructions given in Chapter 5 through 8. Improper and/or incomplete reprocessing or storage can present an infection-control risk, cause equipment damage or reduce performance.
Repair and modification This camera head 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. If problems appear to be malfunctions, contact Olympus.
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HD CAMERA HEAD OTV-S7ProH-HD-L08E
Important Information - Please Read Before Use
Spare equipment Be sure to prepare another camera head to avoid interruption of the examination due to failure or malfunction.
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.
HD CAMERA HEAD OTV-S7ProH-HD-L08E
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Important Information - Please Read Before Use
Dangers and warnings Follow the dangers and warnings given below when handling this camera head. This information is to be supplemented by the dangers, warnings and cautions given in each chapter.
•
Failure to adhere to the following precautions may place the patient and medical personnel in danger of an electric shock. When this equipment is used to examine a patient, do not allow the metal parts of the endoscope or its accessories to touch metal parts of other system components. This camera head is electrically connected to metal parts of other system components, and contact may cause unintended current flow to the patient. Do not prepare, inspect or use this equipment with wet hands.
•
Never install and/or operate the camera head under the following conditions. Otherwise, an explosion or a fire may occur. 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.
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•
Push the video plug until it clicks into the video system center, then confirm that the video plug is securely attached by pulling it gently, improper connection will damage the CCD. A damaged CCD will display no image and make the camera head hot, which could cause operator and/or patient burns.
•
This product may interfere with other medical electronic equipment used in combination with it. Before use, fully confirm the compatibility of this camera head with all equipment to be used.
•
Do not use this product in any place where it may be subject 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 product.
HD CAMERA HEAD OTV-S7ProH-HD-L08E
Important Information - Please Read Before Use
•
For reasons described below, do not rely on the NBI1 imaging modality alone for primary detection of lesions or to make a decision regarding any potential diagnostic or therapeutic intervention. It has not been demonstrated to increase the yield or sensitivity of finding any specific mucosal lesion. It has not been demonstrated to aid in differentiating and establishing the presence or absence of dysplasia or neoplastic changes within mucosa or mucosal lesions. 1 NBI stands for Narrow Band Imaging. For more details, refer to the instruction manual for the video system center.
•
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.
•
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.
•
This product is prohibited to be applied to the heart (as the equipment incorporating type-BF applied parts), never use it for procedures aiming at observing or treating the heart. Strictly observe the precautions below. Otherwise, an electric shock will cause serious damage to the patient’s cardiac function such as ventricular fibrillation.
Cardiac applications
Never bring the endoscope connected to this product into contact with the heart and its surrounding tissues. Never bring the endoscope connected to this product into contact with any tool or other endoscope which is in contact with the heart and its surrounding tissues.
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Important Information - Please Read Before Use
Precautions against frozen or lost endoscopic images •
If the endoscopic image unexpectedly disappears or a frozen image cannot be restored during an examination, immediately stop using the camera head and withdraw the endoscope from the patient. Continued use of the endoscope under these conditions may cause patient injury, bleeding and/or perforation.
•
Follow the precautions given below. Otherwise, the endoscopic image may disappear unexpectedly, or it may not be possible to restore a frozen image. Never clean, disinfect, sterilize or store this camera head together with sharp-tipped instruments (tweezers, forceps, knives, etc.). Doing so could scratch or tear holes in the camera cable, that could allow water to penetrate and damage electrical circuits inside the camera head. Do not drop the camera head or allow it to strike other objects. Strong impacts could damage the electrical circuits inside the camera head. Make sure that the video plug and its electrical contacts are completely dry before connecting the plug to the video system center. Wet contacts could cause the equipment to malfunction.
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HD CAMERA HEAD OTV-S7ProH-HD-L08E
Important Information - Please Read Before Use
While uncoiling the camera cable, a part of the cable may form a loop of 10 cm or less in diameter. When such a loop is observed, do not forcibly pull the camera cable, but uncoil the loop and straighten it slowly, rotating the camera head. Forcibly pulling the loop can damage the camera cable.
Never excessively bend, pull, twist, coil, squeeze or crush the camera cable. Doing so could damage the camera cable. Do not use excessive force when wiping the external surfaces of the camera cable. Otherwise, the camera cable could become damaged. Never attempt to lift the entire assembly by the camera cable while the camera head is attached to the endoscope. Doing so could damage the cable. Never use a clamp or forceps to attach the camera cable to another object. Doing so could damage the cable.
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Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the camera head is damaged, a component is missing or you have any questions, do not use the camera head; immediately contact Olympus. This camera head was not disinfected or sterilized before shipment. Before using this camera head for the first time, reprocess it according to the instructions given in Chapter 5, “Reprocessing: General Policy” through Chapter 7, “Cleaning, Disinfection, and Sterilization Procedures”.
Instruction manual
Camera head (OTV-S7ProH-HD-L08E)
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HD CAMERA HEAD OTV-S7ProH-HD-L08E
Chapter 2 Nomenclature and Functions
Chapter 2 Nomenclature and Functions
1. Endoscope mount lock
2. Endoscope mount
3. Endoscope lock button 4. Focus ring 5. Main body
6. Remote control switch SW1 6. Remote control switch SW2 6. Remote control switch SW3
9. UP mark
7. Camera cable Electrical contacts
8. Video plug
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Chapter 2 Nomenclature and Functions
1. Endoscope mount lock This lever is moved to lock and unlock the endoscope mount. 2. Endoscope mount The endoscope is connected to this mount. 3. Endoscope lock button This button is pressed to connect and disconnect the eyepiece of the endoscope to and from the endoscope mount. 4. Focus ring This ring is rotated for initial focus adjustment of the endoscopic image. 5. Main body The image sensor (CCD), that converts the endoscopic image into electrical signals, is located here. 6. Remote control switch SW1, SW2, and SW3 The function of the switch is selected on the video system center. For more information on selecting the functions, refer to the instruction manual for the video system center. 7. Camera cable This cable connects the camera head to the video system center. 8. Video plug This plug is connected to the video connector socket on the front panel of the video system center. 9. UP mark This mark is facing upward when the video plug is connected to the video system center.
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HD CAMERA HEAD OTV-S7ProH-HD-L08E
Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection •
Before each case, prepare and inspect this camera head as instructed below. Inspect other equipment to be used with this camera head as instructed in their respective instruction manuals. Should the slightest irregularity be observed, do not use the camera head; contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage.
•
This camera head was not disinfected or sterilized before shipment. Before using this camera head for the first time, reprocess it according to the instructions given in Chapter 5 through 7.
Prepare this camera head, other compatible equipment to be used with this camera head (listed in the “System chart” in the Appendix), paper towels, basins, lint-free cloths and personal protective equipment, such as eye wear, face mask, moisture-resistant clothing and chemical-resistant gloves, for the procedure. Refer to the respective instruction manuals for each piece of equipment.
3.1
Endoscope selection Refer to Section 3.5, “Connecting and disconnecting the endoscope” on page 17 to check that the endoscope is firmly connected to the camera head, and refer to Section 4.1, “Focus adjustment” on page 22 to check that the endoscopic image is properly displayed on the monitor. Select an endoscope according to type of camera head to be used. Camera head type OTV-S7ProH-HD-L08E
Endoscope mount type
Compatible endoscopes
Eyepiece type
Rigid endoscopes and fiberscopes
Table 3.1
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Chapter 3 Preparation and Inspection
Selection of the endoscope’s mount design Select an endoscope with a mount design that matches the camera head being used (see Figure 3.1).
Eyepiece
Figure 3.1
3.2
Inspection of the camera head Inspect the camera head and video plug for cracks or other damage. If any damage or deterioration is observed, stop using the camera head and send to Olympus for inspection and repair. The camera cable surface may deteriorate after multiple sterilization cycles in specific models of STERRAD sterilization systems. Please consult ASP or Olympus for more specific information. Inspect the camera cable for damage and other irregularities.
A sticky camera cable surface has no influence on the product performance or on the safety.
3.3
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Preparation of ancillary equipment •
To ensure safety, securely connect the power cord of the video system center and the light source to a hospital grade receptacle (wall mains outlet).
•
When using a non-medical monitor or other ancillary equipment, always connect Olympus equipment via an isolation transformer.
HD CAMERA HEAD OTV-S7ProH-HD-L08E
Chapter 3 Preparation and Inspection
Setup the video system center, monitor and other ancillary equipment as described in the video system center instruction manual and the respective instruction manual for each piece of equipment.
3.4
Connecting and disconnecting the camera head to the video system center •
Never excessively bend, pull, twist, coil, squeeze or crush the camera cable. Doing so could damage the camera cable.
•
Make sure that the video plug and its electrical contacts are completely dry before connecting the plug to the video system center. Wet contacts could cause the equipment to malfunction.
Do not connect or disconnect the video plug while the video system center is ON. Doing so may damage the electrical circuits inside the camera head.
Connecting
1. Confirm that the video plug and its electrical contacts are dry (see Figure 3.2). If the video plug is wet, wipe it dry with a clean, lint-free cloth.
UP mark
Video plug Electrical contacts
Figure 3.2
2. Turn the video system center OFF. 3. Hold the video plug so that the UP mark is facing upward (see Figures 3.2 and 3.3).
HD CAMERA HEAD OTV-S7ProH-HD-L08E
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