OTV-S7H- series VISERA VIDEO SYSTEM CENTER Instructions Nov 2011

Contents

Contents Labels and Symbols ...

1

Important Information - Please Read Before Use...

3

Intended use ...

3

Instruction manual ...

3

User qualifications ...

3

Instrument compatibility ...

3

Reprocessing and storage ...

4

Repair and modification ...

4

Signal words ...

4

Dangers and warnings ...

5

Cardiac applications...

6

Precautions against frozen or lost endoscopic images ...

7

Chapter 1

Checking the Package Contents...

8

Chapter 2

Nomenclature and Functions ...

9

Chapter 3

Preparation and Inspection ...

13

3.1

Scope selection...

14

3.2

Inspection of the camera head...

20

3.3

Preparation of ancillary equipment ...

20

3.4

Connecting the camera head to the VISERA video system center OTV-S7V 20

3.5

Connecting the video coupler to the video adapter...

3.6

Connecting the video adapter to the camera head (OTV-S7H-N/1N/1D/NA/1NA/D-6M only)... 23

3.7

Connecting the endoscope ...

24

Operation ...

30

4.1

Focus adjustment...

32

4.2

Positioning the scope image ...

34

4.3

Color adjustment...

36

4.4

Setting the remote control switches (except for OTV-S7H-1D-F08E/L08E/D-L08E) ... 37

4.5

Finder observation (OTV-S7H-1D-F08E only) ...

38

Reprocessing: General Policy...

39

Instructions...

39

Chapter 4

Chapter 5 5.1

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

23

i

Contents

5.2

Chapter 6

39

Compatible Reprocessing Methods and Chemical Agents ...42

6.1

Compatibility summary...

42

6.2

Detergent solution ...

44

6.3

Disinfectant solution ...

44

6.4

Rinsing water ...

44

6.5

ETO gas sterilization ...

45

6.6

Steam sterilization (autoclaving) ...

46

Chapter 7

Cleaning, Disinfection and Sterilization Procedures 48

7.1

Required reprocessing equipment ...

48

7.2

Cleaning, disinfection and sterilization procedures ...

50

7.3

Precleaning ...

54

7.4

Manual cleaning ...

60

7.5

High-level disinfection ...

61

7.6

Sterilization ...

63

Care, Storage and Disposal ...

65

8.1

Wiping the surface and cover glass ...

65

8.2

Storage ...

67

8.3

Disposal ...

67

Troubleshooting ...

68

Returning the camera head for repair ...

68

Appendix...

69

System chart ...

69

Operating environment ...

72

Transportation and storage environment ...

72

Specifications ...

73

EMC information...

78

Chapter 8

Chapter 9

ii

Precautions ...

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

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. Caution, refer to instructions. Type CF Applied Part

 Camera head

Warning plate Caution and model name.

Warning plate *Example from OTV-S7H-N

• NTSC

• PAL

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

1

Labels and Symbols

 Back cover of this instruction manual Manufacturer

Authorised representative in the European Community

2

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use These instruments have been designed to be used with an Olympus VISERA video system center OTV-S7V, video adapter, video coupler, endoscope, light source, video monitor and other ancillary equipment for endoscopic observation, diagnosis and treatment. Do not use these instruments for any purposes other than their intended uses.

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.

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.

Instrument compatibility Refer to the “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.

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

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Important Information - Please Read Before Use

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 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 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. If problems appear to be malfunctions, 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.

4

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

Important Information - Please Read Before Use

Dangers and warnings Follow the danger and warning statements given below when handling this instrument. 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 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 instrument 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 OTV-S7V in the following locations. 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.

•

Be sure to prepare another camera head to ensure that the examination does not need to be interrupted 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 instrument with all equipment to be used with it.

•

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.

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

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Important Information - Please Read Before Use

Cardiac applications •

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, which 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)” which are suitable for cardiac applications bear a

•

6

symbol.

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

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, 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 instrument 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 instrument together with sharp-tipped instruments (tweezers, forceps, knives, etc.). These could scratch or tear holes in the camera cable, which could allow water to penetrate and damage electrical circuits inside the instrument.  Do not drop the camera head or allow it to strike other objects. Strong impacts could damage the electrical circuits inside the instrument.  Make sure that the video plug and its electrical contacts are completely dry before connecting the plug to the OTV-S7V. Wet contacts could cause the equipment to malfunction.  Never excessively bend, pull, twist, coil, squeeze or apply a crushing force to the camera cable. The camera cable could become damaged.  Do not use excessive force when wiping the external surfaces of the camera cable. Otherwise, the camera cable could become damaged.  While the camera head is attached to the endoscope, never attempt to lift the entire assembly by the camera cable. 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.

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

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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 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 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.

Instruction manual

Camera head

8

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

Chapter 2 Nomenclature and Functions

Chapter 2 Nomenclature and Functions 1. Adapter mount 2. Remote control switch SW1

2. Remote control switch SW2

OTV-S7H-N/1N

3. Color code 14. UP mark 13. Video plug 12. Camera cable

14. UP mark

15. Protective cap

13. Video plug

Electrical contacts Only OTV-S7H-D-6M 2. Remote control switch SW2 2. Remote control switch SW1

1. Adapter mount

2. Remote control switch SW1

1. Adapter mount

2. Remote control switch SW2

3. Color code 3. Color code

OTV-S7H-1D/D-6M

OTV-S7H-NA/1NA

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

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Chapter 2 Nomenclature and Functions

4. Endoscope mount

6. Endoscope mount lock

5. Endoscope lock button

8. Finder cap

7. Finder

9. Focus ring

11. Main body

3. Color code

OTV-S7H-1D-F08E/L08E/D-L08E

1 This product is not available in some areas.

2. Remote control switch SW1 2. Remote control switch SW3

4. Endoscope mount

2. Remote control switch SW2 9. Focus ring

6. Endoscope mount lock

4. Endoscope mount

9. Focus ring

2. Remote control switch SW3 2. Remote control switch SW1

3. Color code 10. Endoscope lock ring

3. Color code

OTV-S7H-NA-10Q/12Q, OTV-S7H-1NA-12Q

2. Remote control switch SW2 10. Endoscope lock ring OTV-S7H-NA-10E/12E, OTV-S7H-1NA-10E/12E

10

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

Chapter 2 Nomenclature and Functions

1. Adapter mount The video adapter is connected to this mount. 2. Remote control switch SW1, SW2 and SW3 The function of the switch is selected on the OTV-S7V VISERA video system center. For more information on selecting the functions, refer to the instruction manual for the OTV-S7V. 3. Color code When using a rigid endoscope without a fiber imaging bundle, use the OTV-S7H-N/D-6M/NA, OTV-S7H-D-L08E, OTV-S7H-NA-10E/12E/10Q/12Q (camera heads with a black ring). When using a fiberscope or rigid endoscopes with a fiber imaging bundle, use the OTV-S7H-1N/1D/1NA, OTV-S7H-1D-F08E/L08E, OTV-S7H-1NA-10E/12E/12Q (camera heads with an orange ring). 4. Endoscope mount The endoscope is connected to this mount. 5. Endoscope lock button This button is pressed to connect and disconnect the eyepiece of the endoscope to and from the endoscope mount. 6. Endoscope mount lock This lever is moved to lock and free the endoscope mount. 7. Finder Used when observing an endoscopic image with the naked eye. 8. Finder cap This cap is attached to prevent extraneous light from entering the finder when the finder is not used. 9. Focus ring This ring is rotated for initial focus adjustment of the endoscopic image. 10. Endoscope lock ring Operating this ring locks the endoscope to the mount. 11. Main body The image sensor (CCD), which converts the endoscopic image into electrical signals, is located here. 12. Camera cable Connects the camera head to the OTV-S7V VISERA video system center.

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

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Chapter 2 Nomenclature and Functions

13. Video plug This plug is connected to the video connector socket on the front panel of the OTV-S7V VISERA video system center. 14. UP mark When the video plug is connected to the OTV-S7V, this mark is facing upward. 15. Protective cap This cap is attached to the video plug when the camera head is not used.

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VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

Chapter 3 Preparation and Inspection

Chapter 3 Preparation and Inspection •

Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment to be used with this instrument as instructed in their respective instruction manuals. Should any irregularity be observed, do not use the instrument; contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more severe equipment damage.

•

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 Chapters 5 through 7.

Prepare this instrument, other compatible equipment to be used with this instrument (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.

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

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Chapter 3 Preparation and Inspection

3.1

Scope selection Refer to Section 3.7, “Connecting the endoscope” on page 24 to check that the endoscope is firmly connected to the camera head, and refer to Section 4.1, “Focus adjustment” on page 32 to check the endoscopic image is properly displayed on the video monitor. Select an endoscope according to the type of the camera head to be used.

Camera head type

Need video adapter (optional)?

Endoscope mount type

Compatible endoscopes

Yes:  No: – (magnification) OTV-S7H-N



–

OTV-S7H-NA



–

OTV-S7H-D-6M



–

OTV-S7H-1N



–

OTV-S7H-1D



–

OTV-S7H-1NA



–

OTV-S7H-1D-F08E

– (0.8 ×)

Eye-piece type

OTV-S7H-1D-L08E

– (0.8 ×)

Eye-piece type

OTV-S7H-NA-10E

– (1.0 ×)

Eye-piece type

OTV-S7H-NA-12E

– (1.2 ×)

Eye-piece type

OTV-S7H-NA-10Q

– (1.0 ×)

Quick-lock type

OTV-S7H-NA-12Q

– (1.2 ×)

Quick-lock type

OTV-S7H-D-L08E

– (0.8 ×)

Eye-piece type

OTV-S7H-1NA-10E

– (1.0 ×)

Eye-piece type

OTV-S7H-1NA-12E

– (1.2 ×)

Eye-piece type

OTV-S7H-1NA-12Q

– (1.2 ×)

Quick-lock type

Rigid endoscopes without a fiber imaging bundle.

Rigid endoscopes and fiberscopes

Rigid endoscopes without fiber imaging bundle

Rigid endoscopes and fiberscopes

Table 3.1

The magnification given above is based on the assumption that the magnification of the image on the monitor is 1.0 × when captured using an OTV-S7H-N camera head with an AR-T10 video adapter. •

14

The OTV-S7H-1D/D-6M is not angled.

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

Chapter 3 Preparation and Inspection

•

Two models with angled camera heads are available: one with a viewfinder (OTV-S7H-1D-F08E) and the other without a viewfinder (OTV-S7H-1D-L08E/D-L08E).

•

The following models are autoclavable: OTV-S7H-NA/1NA, OTV-S7H-NA-10E/12E/10Q/12Q, OTV-S7H-1NA-10E/12E/12Q.

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

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Chapter 3 Preparation and Inspection

 Selection of the scope imaging system •

When using camera heads with a black color code, select a rigid endoscope without a fiber image guide. This will provide images with high resolution appropriate for a rigid scope (see Figure 3.1).

•

When using camera heads with an orange color code, either a rigid endoscope or fiberscope can be used (see Figure 3.2). Scope images with minimized moiré can be obtained by combining this camera head with a fiberscope (see Figure 3.3).

•

When using the camera head with rigid endoscopes only, select a camera head with a black color code (see Figure 3.1).

•

When using the camera head with fiberscopes and rigid endoscopes, select a camera head with a orange color code (see Figure 3.2).

Black color code

OTV-S7H-NA-10E/12E

Black color code

Black color code

OTV-S7H-D-6M

OTV-S7H-N

Black color code

Black color code

OTV-S7H-NA-10Q/12Q

OTV-S7H-NA

Black color code

OTV-S7H-D-L08E (Without finder)

Figure 3.1

16

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

Chapter 3 Preparation and Inspection

Orange color code

Orange color code

OTV-S7H-1NA-10E/12E OTV-S7H-1N Orange color code Orange color code

OTV-S7H-1NA-12Q OTV-S7H-1NA

Orange color code Orange color code

Orange color code

OTV-S7H-1D-L08E (Without finder)

OTV-S7H-1D-F08E (With finder)

OTV-S7H-1D

Figure 3.2

Figure 3.3

VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD, AUTOCLAVABLE CAMERA HEAD

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