OTV-SP1H-NA-12E-12Q and OTV-SP1H-N-12E-12Q AUTOCLAVABLE CAMERA HEAD Instructions June 2014

Contents

Contents Labels and Symbols ...

1

Important Information - Please Read Before Use...

4

Intended use ...

4

Instruction manual ...

4

User qualifications ...

4

Instrument compatibility ...

5

Reprocessing and storage ...

5

Repair and modification ...

5

Signal words...

6

Dangers, warnings and cautions ...

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 ...

14

3.1

Camera head selection ...

15

3.2

Inspection of the camera head...

16

3.3

Preparation of ancillary equipment ...

17

3.4

Connecting the camera head to the 3CCD camera control unit OTV-SP1C/OTV-SP1C-G /EVIS EXERA II video system center CV-180 ... 17

3.5

Connecting the endoscope ...

20

Operation ...

24

4.1

Focus adjustment...

26

4.2

Positioning the scope image ...

27

4.3

Color adjustment...

29

4.4

Setting the remote control switches ...

30

Reprocessing: General Policy...

31

5.1

Instructions...

31

5.2

Precautions ...

32

Chapter 4

Chapter 5

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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Contents

Chapter 6

Compatible Reprocessing Methods and Chemical Agents ...

34

6.1

Compatibility summary...

34

6.2

Detergent solution ...

35

6.3

Disinfectant solution ...

36

6.4

Rinsing water ...

36

6.5

ETO gas sterilization ...

37

6.6

Steam sterilization (autoclaving) ...

38

Cleaning, Disinfection and Sterilization Procedures ...

40

7.1

Required reprocessing equipment ...

40

7.2

Cleaning, disinfection and sterilization procedures ...

41

7.3

Precleaning ...

43

7.4

Manual cleaning ...

48

7.5

High-level disinfection (only for the USA)...

50

7.6

Sterilization ...

52

Care, Storage and Disposal ...

54

8.1

Wiping the surface and cover glass ...

54

8.2

Storage ...

55

8.3

Disposal ...

56

Troubleshooting ...

57

9.1

Returning the camera head for repair ...

57

9.2

Troubleshooting guide ...

58

Appendix...

59

System chart ...

59

Operating environment ...

62

Transportation and storage environment ...

62

Specifications ...

63

EMC information...

65

Chapter 7

Chapter 8

Chapter 9

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3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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

 OTV-SP1H-NA-12E/12Q

Serial number

Warning plate Caution and model name.

Warning plate Example from OTV-SP1H-NA-12E

• NTSC

• PAL

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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Labels and Symbols

Caution, refer to instructions. TYPE CF applied part

 OTV-SP1H-N-12E/12Q

Warning plate Caution and model name. Warning plate

Example from OTV-SP1H-N-12E

• PAL

• NTSC

Serial number

2

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

Labels and Symbols

 Back cover of this instruction manual Manufacturer

Authorised representative in the European Community

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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Important Information - Please Read Before Use

Important Information - Please Read Before Use Intended use These instruments have been designed to be used with a camera control unit or video system center, 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.

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3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

Important Information - Please Read Before Use

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. This instrument complies with medical electrical equipment edition 2 (IEC 60601-1-2: 2001). However when connecting with an instrument complies with medical electrical equipment edition 1 (IEC 60601-1-2: 1993), the whole system complies edition 1 (See “EMC compliance information” in the Appendix for EMC compliance level).

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. 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.

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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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, warning and cautions 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 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 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.

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3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

Important Information - Please Read Before Use

•

Never install and/or operate in the following 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. Otherwise, an explosion or fire may occur.

•

Be sure to prepare another camera head to avoid that the examination must be interrupted due to equipment failure or malfunction.

•

This product may interfere with other medical electronic equipment used in combination with it. Before use, thoroughly 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.

•

Be sure not to bring and/or pile up this instrument too close to other instruments to avoid an electromagnetic interference from them.

•

Electromagnetic interference may occur on this instrument near a portable device and a mobile RF communications equipment such as a cellphone marked with the following symbol:

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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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, 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: 1988 (included amendment 1,2), 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 metalic 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 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.

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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 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-SP1C/OTV-SP1C-G/CV-180. 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.

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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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

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3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

Chapter 2 Nomenclature and Functions

Chapter 2 Nomenclature and Functions 1. Remote control switch SW3

2. Endoscope mount lock

1. Remote control switch SW1

3. Endoscope mount

1. Remote control switch SW2

4. Endoscope lock ring

5. Focus ring

8. UP mark

OTV-SP1H-NA-12E 6. Camera cable

1. Remote control switch SW1 7. Video plug

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

Electrical contacts

3. Endoscope mount

OTV-SP1H-NA-12Q 4. Endoscope lock ring

5. Focus ring

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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Chapter 2 Nomenclature and Functions

3. Endoscope mount 1. Remote control switch SW2 1. Remote control switch SW1 1. Remote control switch SW3

4. Endoscope lock ring 9. Free locking knob 5. Focus ring OTV-SP1H-N-12E

1. Remote control switch SW2

3. Endoscope mount

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

4. Endoscope lock ring

5. Focus ring OTV-SP1H-N-12Q

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3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

Chapter 2 Nomenclature and Functions

1. Remote control switch SW1, SW2 and SW3 The function of the switch is selected on the 3CCD camera control unit OTV-SP1C/OTV-SP1C-G/EVIS EXERA II video system center CV-180. For more information on selecting the functions, refer to the instruction manual for the OTV-SP1C/OTV-SP1C-G. 2. Endoscope mount lock This lever is moved to lock and unlock the endoscope mount. 3. Endoscope mount The endoscope is connected to this mount. 4. Endoscope lock ring Operating this ring locks the endoscope to the mount. 5. Focus ring This ring is rotated for initial focus adjustment of the endoscopic image. 6. Camera cable The camera head is linked to the 3CCD camera control unit OTV-SP1C/OTV-SP1C-G/EVIS EXERA II video system center CV-180. 7. Video plug This plug is connected to the video connector socket on the front panel of the 3CCD camera control unit OTV-SP1C/OTV-SP1C-G/EVIS EXERA II video system center CV-180. 8. UP mark When the video plug is connected to the OTV-SP1C/OTV-SP1C-G/CV-180, this mark is facing upward. 9. Free locking knob By loosing the free locking knob, the endoscope mount can be rotated. By tightening it, the endoscope mount can fix.

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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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 the slightest irregularity be suspected, 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.

•

Moisture adhering to the cover glass of the camera head will impede observation and trouble may be caused to an operation. Dry the camera head thoroughly before using.

Prepare all equipment and personal protective equipment which will be used with the instrument in accordance with their respective instruction manuals. Appropriate personal protective equipment may include: eye wear, a face mask, moisture-resistant clothing and chemical-resistant gloves.

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3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

Chapter 3 Preparation and Inspection

3.1

Camera head selection Refer to Section 3.5, “Connecting 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 video monitor. For the OES 3CCD progressive video system OTV-SP1, the following four camera heads are provided. Each camera head requires a different method of cleaning, disinfection and sterilization (see Table 3.1), and the connectable endoscopes are different according to the type of camera head (see Table 3.1). Confirm that the combination is suitable.

Camera head type

Connectable endoscope mount type

OTV-SP1H-NA-12E

Eye-piece type

OTV-SP1H-NA-12Q

Quick-lock type

Compatible endoscopes Rigid endoscopes without fiber imaging bundle

Compatible reprocessing methods and chemical agents • Wiping with 70% ethyl or isopropyl alcohol • Cleaning with detergent solutions • Disinfection with 2.0 – 3.2% glutaraldehyde solution • Sterilization with ethylene oxide gas • Sterilization with autoclave

OTV-SP1H-N-12E

Eye-piece type

OTV-SP1H-N-12Q

Quick-lock type

• Wiping with 70% ethyl or isopropyl alcohol • Cleaning with detergent solutions • Disinfection with 2.0 – 3.2% glutaraldehyde solution • Sterilization with ethylene oxide gas

Table 3.1

•

Refer to Chapter 6, “Compatible Reprocessing Methods and Chemical Agents” for detailed descriptions of appropriate ways of cleaning, disinfection and sterilization.

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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Chapter 3 Preparation and Inspection

•

A camera head to which autoclave sterilization is suitable is marked with “AUTOCLAVE” or “Autoclavable” on the exterior. Autoclave sterilization is not available for the OTV-SP1H-N-12E or OTV-SP1H-N-12Q.

•

Connectable endoscope mount types: “Eye-piece” type means the shape of the mount of a typical rigid endoscope. “Quick-lock” type means the shape of the mount of some of Olympus’ rigid endoscopes fitted with Quick-lock eyepiece (see Figure 3.1).

OTV-SP1H-NA-12E, OTV-SP1H-N-12E

Eyepiece

OTV-SP1H-NA-12Q, OTV-SP1H-N-12Q

Figure 3.1

3.2

Inspection of the camera head 1. Inspect the camera head for cracks or other damage. Confirm that the camera cable is not damaged.

2. After preparing Section 3.3 – 3.5, refer to Chapter 4, “Inspection” in the OTV-SP1C’s/OTV-SP1C-G’s/CV-180’s instruction manual, inspect the image.

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3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

Chapter 3 Preparation and Inspection

3.3

Preparation of ancillary equipment •

To ensure safety, securely connect the power cord of the OTV-SP1C/OTV-SP1C-G/CV-180 and the light source to a hospital grade receptacle (wall mains outlet).

•

When using a non-medical video monitor or other ancillary equipment, always connect Olympus equipment via an isolation transformer.

Setup the OTV-SP1C/OTV-SP1C-G/CV-180, video monitor and other ancillary equipment as described in the OTV-SP1C’s/OTV-SP1C-G’s/CV-180’s instruction manual and the respective instruction manuals for each instrument.

3.4

Connecting the camera head to the 3CCD camera control unit OTV-SP1C/OTV-SP1C-G /EVIS EXERA II video system center CV-180 •

Never excessively bend, pull, twist, coil, squeeze or apply a crushing force to the camera cable. The camera cable could become damaged.

•

Make sure that the video plug and its electrical contacts are completely dry before connecting the plug to the OTV-SP1C/OTV-SP1C-G/CV-180. Wet contacts could cause the equipment to malfunction.

•

Do not connect or disconnect the video plug while the OTV-SP1C/OTV-SP1C-G/CV-180 is ON. Doing so may damage the electrical circuits inside the camera head.

•

After autoclaving, do not use the camera head until it has cooled down to room temperature. Otherwise, the video image may be impaired (“noise” etc.) (OTV-SP1H-NA-12E/12Q).

•

After autoclaving, let all components cool down to room temperature without additional cooling. Sudden changes in temperature may damage the instruments. Never rinse the instruments with cooled water for cooling (OTV-SP1H-NA-12E/12Q).

3CCD AUTOCLAVABLE CAMERA HEAD OTV-SP1H-NA-12E/12Q 3CCD CAMERA HEAD OTV-SP1H-N-12E/12Q

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