OTV-S7ProH series HD Autoclavable Camera Head Instructions Rev 13 Jan 2022

Contents

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

Signal words...

5

Dangers and warnings ...

6

Cardiac applications...

8

Precautions against frozen or lost endoscopic images ...

9

Chapter 1

Checking the Package Contents...

10

Chapter 2

Nomenclature and Functions ...

11

Chapter 3

Preparation and Inspection ...

15

3.1

Endoscope selection...

16

3.2

Inspection of the camera head...

17

3.3

Preparation of ancillary equipment ...

17

3.4

Connecting and disconnecting the camera head to the video system center ...

17

Connecting and disconnecting the endoscope ...

20

Operation ...

24

4.1

Focus adjustment...

26

4.2

Positioning the endoscopic image ...

27

4.3

Color adjustment...

28

4.4

Observation of the NBI image...

28

4.5

Setting the remote control switches ...

29

Reprocessing: General Policy...

30

5.1

Instructions...

30

5.2

Notes for cleaning, disinfection, and sterilization ...

30

5.3

Precautions ...

31

3.5

Chapter 4

Chapter 5

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Contents

Chapter 6 6.1

Compatibility summary...

33

6.2

Detergent solution ...

35

6.3

Disinfectant solution ...

35

6.4

Rinsing water ...

35

6.5

ETO gas sterilization ...

36

6.6

Steam sterilization (autoclaving) ...

37

6.7

Automatic cleaning/disinfection...

38

Cleaning, Disinfection, and Sterilization Procedures ...

40

7.1

Required reprocessing equipment ...

40

7.2

Cleaning, disinfection, and sterilization procedures ...

41

7.3

Precleaning ...

42

7.4

Manual cleaning ...

44

7.5

High-level disinfection ...

45

7.6

Rinsing after high-level disinfection...

46

7.7

Automatic cleaning/disinfection...

47

7.8

Sterilization ...

48

Care, Storage, and Disposal ...

50

8.1

Wiping the surface and cover glass ...

50

8.2

Storage ...

51

8.3

Disposal ...

52

Troubleshooting ...

53

Returning the camera head for repair ...

53

Appendix...

55

System chart ...

55

Operating environment ...

58

Transportation and storage environment ...

58

Specifications ...

59

EMC information...

62

Chapter 7

Chapter 8

Chapter 9

ii

Compatible Reprocessing Methods and Chemical Agents... 33

HD AUTOCLAVABLE CAMERA HEAD

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 CF applied part

Model name plate Model name Caution indication Caution see below

Model name plate (example from OTV-S7ProH-HD-12E)

HD AUTOCLAVABLE CAMERA HEAD

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Labels and Symbols

 Back cover of this instruction manual Manufacturer

Authorized representative in the European Community Importer (into European Union)

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HD AUTOCLAVABLE CAMERA HEAD

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use These camera heads have been designed to be used with the CV-180 EXERA II video system center or OTV-S7Pro VISERA Pro video system center1, endoscope, light source, monitor and other ancillary equipment for endoscopic observation, diagnosis, and treatment. Do not use these camera heads 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 these camera heads 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 the 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 EMC standard for medical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument that complies with EMC standard for medical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.

Reprocessing and storage The camera heads were 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 Chapters 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 The camera heads do 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 AUTOCLAVABLE CAMERA HEAD

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.

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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 video system center 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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•

Be sure to prepare another camera head to avoid interruption of the examination due to equipment failure or malfunction.

•

This product may interfere with other medical electronic equipment used in combination with it. Before use, fully confirm the compatibility of this camera head to all equipment with which it will 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 AUTOCLAVABLE CAMERA HEAD

Important Information - Please Read Before Use

•

For reasons described below, do not rely on the NBI1 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 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 of 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.

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Important Information - Please Read Before Use

Cardiac applications

8

•

Use only the devices listed in the “System chart” for endoscopic observation or treatment of the heart or areas near the heart. Other combinations of equipment may cause ventricular fibrillation or seriously affect the cardiac function of the patient.

•

For cardiac applications, never support the endoscope with a metal surgical arm that is not electrically isolated from the ground. If not isolated, the endoscope will be connected to the ground through the surgical arm and bed, and will conduct unexpected leakage current that may seriously affect the cardiac function of the patient.

•

The use of medical devices not specifically designed for cardiac applications may cause ventricular fibrillation or seriously affect the cardiac function of the patient. As specified by international standard IEC 60601-1, any “Applied part” used for observation or treatment of the heart or areas near the heart must meet “TYPE CF applied part” requirements for low electrical leakage current. When using metal endoscopes for endoscopic cardiac applications, the “Applied part” requirements include all devices directly connected to the endoscope, such as the light-guide cable, camera head, and telescope holder. Each of these devices must individually meet the “TYPE CF applied part” requirements for leakage current limits if they are to be used for cardiac applications.

•

The Olympus light-guide cables and camera heads listed in the “System chart (TYPE CF applied part)” that are suitable for cardiac applications bear a symbol.

•

The Olympus SH-1 surgical telescope holder has an electrically isolated arm structure that isolates the endoscope from the ground. This design makes the SH-1 suitable for cardiac applications.

HD AUTOCLAVABLE CAMERA HEAD

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, which 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.  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; 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”. Depending upon the camera head purchased, it may appear different from that shown in the figure below.

Camera head (OTV-S7ProH-HD-10E/12E)

Camera head (OTV-S7ProH-HD-10Q/12Q)

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HD AUTOCLAVABLE CAMERA HEAD

Instruction manual

Instruction manual

Chapter 2 Nomenclature and Functions

Chapter 2 Nomenclature and Functions 3. Endoscope mount lock

2. Endoscope mount

4. Focus ring 1. Remote control switch SW3 1. Remote control switch SW1 1. Remote control switch SW2

9. Magnification ratio indicator

5. Endoscope lock ring

OTV-S7ProH-HD-10E

8. UP mark 7. Video plug

6. Camera cable

1. Remote control switch SW3 Electrical contacts

1. Remote control switch SW2 1. Remote control switch SW1

2. Endoscope mount 5. Endoscope lock ring

4. Focus ring

9. Magnification ratio indicator

OTV-S7ProH-HD-10Q

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Chapter 2 Nomenclature and Functions

3. Endoscope mount lock

2. Endoscope mount

4. Focus ring 1. Remote control switch SW3 1. Remote control switch SW1

5. Endoscope lock ring

1. Remote control switch SW2

9. Magnification ratio indicator

OTV-S7ProH-HD-12E

1. Remote control switch SW3 1. Remote control switch SW2 1. Remote control switch SW1

2. Endoscope mount 5. Endoscope lock ring

4. Focus ring 9. Magnification ratio indicator OTV-S7ProH-HD-12Q

1. 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. 2. Endoscope mount The endoscope is connected to this mount. 3. Endoscope mount lock This lever is moved to lock and unlock the endoscope mount. 4. Focus ring This ring is rotated for initial focus adjustment of the endoscopic image. 5. Endoscope lock ring Operating this ring locks the endoscope to the mount.

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HD AUTOCLAVABLE CAMERA HEAD

Chapter 2 Nomenclature and Functions

6. Camera cable This cable connects the camera head to the video system center. 7. Video plug This plug is connected to the video connector socket on the front panel of the video system center. 8. UP mark This mark is facing upward when the video plug is connected to the video system center. 9. Magnification ratio indicator This mark indicates the magnification ratio. Camera head type

Magnification ratio

OTV-S7ProH-HD-10E/10Q

1.0X

OTV-S7ProH-HD-12E/12Q

1.2X

Table 2.1   Please note that some products may not have this magnification ratio indicator.

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Chapter 2 Nomenclature and Functions

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HD AUTOCLAVABLE CAMERA HEAD

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 any 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 Chapters 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.

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Chapter 3 Preparation and Inspection

3.1

Endoscope selection Refer to Section 3.5, “Connecting and disconnecting the endoscope” on page 20 to check that the endoscope is firmly connected to the camera head, and refer to Section 4.1, “Focus adjustment” on page 26 to check the endoscopic image is properly displayed on the monitor. Select an endoscope according to the type of the camera head to be used. Camera head type

Endoscope mount type

Compatible endoscopes

OTV-S7ProH-HD-10E/12E

Eyepiece type

Rigid Endoscopes

OTV-S7ProH-HD-10Q/12Q

Quick-lock type

Rigid Endoscopes

Table 3.1

 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).

OTV-S7ProH-HD-10E/12E

Eyepiece

OTV-S7ProH-HD-10Q/12Q

Figure 3.1

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HD AUTOCLAVABLE CAMERA HEAD

Chapter 3 Preparation and Inspection

3.2

Inspection of the camera head Inspect the camera head for cracks or other damage. Confirm that the camera cable is not damaged.

3.3

•

When turning the endoscope mount lock counterclockwise with holding it lightly, confirm that the endoscope mount lock is free from looseness or backlash.

•

When operating the endoscope mount, confirm that the endoscope mount is free from looseness or backlash.

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 nonmedical monitor or other ancillary equipment, always connect Olympus equipment via an isolation transformer.

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.

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