UST-2265-2 Instruction Manual MNI-0833 Rev 25 Aug 2017

MN1-0833 Rev. 25

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Introduction This is an instruction for model UST-2265-2, an ultrasound probe. Read the manual carefully before using the instrument. Take special note of the items in section 1, "Safety Precautions". Keep this manual securely for future reference. The CE mark on the probe indicates that this probe is valid when it is connected to equipment bearing the CE mark that is specified as available in section 2 of this document. Therefore, if a probe bearing the CE mark is connected to equipment that is specified as available but does not have a CE mark, part of this instruction manual may not apply.

Symbols used in this document The terms below are used in the safety information provided to prevent hazards and injuries to the operator or patients. The severity of the hazard and injury that can occur when failing to observe the displayed safety information are indicated in four levels: "Danger", "Warning", "Caution" and "Note".

Danger Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury to the operator or patient.

Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury to the operator or patient.

Caution Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the operator or patient, or property damage only.

Note Indicates a strong request concerning an item that must be observed in order to prevent damage or deterioration of the equipment and also to ensure that it is used efficiently. The type of safety information is indicated by the symbols below. This symbol means attention is required. This symbol means that the described action is prohibited. This symbol means the described action is mandatory.

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CONTENTS 1. Safety Precautions... 1 1-1. Intended use... 1 1-2. Usage precautions... 1 1-2-1. Warnings and safety information... 2 1-2-2. Cleaning, disinfection and sterilization precautions... 3 1-2-3. Labels... 4

2. Specifications and Parts name... 9 2-1. Principles of operation... 9 2-2. Specifications... 10 2-3. Performance... 11 2-4. Name of each parts... 11 2-5. Environmental conditions... 12 2-5-1. Operating environmental conditions... 12 2-5-2. Storage environmental conditions... 12 2-6. Classification of ME equipment... 12

3. Preparations for Use... 13 3-1. Start up check... 13 3-1-1. Visual check... 13 3-1-2. Verification of cleaning, disinfection and sterilization... 13 3-1-3. Verification of operation... 13

4. Usage... 15 4-1. Operation... 15 4-2. Connecting to the ultrasound diagnostic instrument... 16 4-3. Removing from the ultrasonic diagnostic instrument... 17 4-4. Actions to be taken when an abnormal state is detected... 18 4-4-1. Ensuring safety of patients... 18 4-4-2. Handling the instrument... 18

5. Cleaning, disinfection and sterilization ... 19 5-1. Precautions for cleaning, disinfection and sterilization... 20 5-2. Reprocessing instruction according to ISO 17664... 21 5-3. Point of use (Pre-cleaning)... 23 5-4. Containment and transportation... 23

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5-5. Manual cleaning and disinfection ... 24 5-5-1. Manual cleaning ... 24 5-5-2. Manual disinfection ... 25 5-5-3. Cable and connector... 25 5-6. Automated cleaning and disinfecting ... 26 5-7. Applicable cleaners and disinfectants / Suppliers List ... 27 5-8. Drying... 29 5-9. Maintenance, inspection and testing... 29 5-10. Packaging... 29 5-11. Sterilization... 30 5-11-1. Ethylene oxide (EtO) gas sterilization... 30 5-11-2. STERRAD® sterilization... 31 5-11-3. Liquid sterilization (USA only)... 32 5-12. Storage... 32

6. Storage... 33 6-1. Actions before storing the probe... 33 6-2. Environmental conditions for storage... 33

7. Moving and Transporting... 35 7-1. Moving and transporting... 35 7-2. Preparing the probe and accessories for moving... 35 7-3. Packing for transportation... 35 7-4. Environmental conditions during transportation... 35

8. Periodic Inspection... 37 8-1. Safety tests... 37

9. Configuration... 39 9-1. Standard configuration... 39

10. Disposal of the Device... 41

This Instruction Manual contains the main body of 42pages and 5pages until the CONTENTS.

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1. Safety Precautions 1-1. Intended use

This probe is intended for use by a doctor or other qualified operator when placed into direct contact with the skin making ultrasonic observations of surrounding organs. Please refer to the ultrasound diagnostic instrument instruction manual used with this probe for the probe intended use information. Regarding with the connectable instrument, please refer to section 2-2. Specifications of this manual.

Caution Do not use this equipment for other than its intended purpose. Use for other purposes can cause burns or other injuries to the patient or operator.

1-2. Usage precautions

The terms below are used in the safety information provided to prevent hazards and injuries to the operator or patients. The severity of the hazard and injury that can occur when failing to observe the displayed safety information are indicated in four levels: "Danger", "Warning", "Caution" and "Note".

Danger Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury to the operator or patient.

Warning Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury to the operator or patient.

Caution Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the operator or patient, or property damage only.

Note Indicates a strong request concerning an item that must be observed in order to prevent damage or deterioration of the equipment and also to ensure that it is used efficiently. The type of safety information is indicated by the symbols below. This symbol means attention is required. This symbol means that the described action is prohibited. This symbol means the described action is mandatory.

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1-2-1. Warnings and safety information

Warning Follow the information in this manual and the documentation supplied with any equipment used together with this probe. Use that is not in accordance with the supplied documentation can result in a serious or moderate injury, equipment breakdown, or physical damage that impairs operation. Be sure to preparations for use. Use of the probe while failing to notice an abnormal condition can result in injury to the operator or patient. If any abnormalities are noted on the probe in the start up inspection, immediately stop using it and contact one of our offices and/or distributor's offices listed on the back cover. See section 3-1 “Start up check” for the start up inspection content and procedure. Do not use on the eyes. This probe is not intended for use on the eyes. The acoustic output can have an adverse effect on the eyes. Do not attempt to disassemble, modify, or repair the probe. Electric shock or other unforeseen accidents could result. Contact one of our offices and/or distributor's offices listed on the back cover to request repair. Clean, disinfect and sterilize before using the probe. Perform proper cleaning, disinfection and sterilization after use. Otherwise, there is a risk of infection. Note that the probe is not sterilized at the factory. Before using the probe first, be sure to clean, disinfect and sterilize it. Wear medical gloves during examination. Conducting examinations with the bare hands can expose the operator to a risk of infection. Dispose the probe used for patients with Creutzfeldt-Jakob disease. Otherwise, there is a risk of infection to the operator or patient. Our ultrasound probe is not compatible with any disinfection/sterilization method for Creutzfeldt-Jakob disease. Do not use the probe fallen on to floor. Ohterwise, there is a risk of infection. Stop the operation and perform the procedure in section 8 "Periodic Inspection", section 5 "Cleaning, disinfection and sterilization" and section 3-1 "Start up check".

Caution Constantly check for anything abnormal about the patient’s condition and probe. Continued use without noticing that an abnormal condition has occurred can result in an electric shock and injury to the operator or patient. If an abnormal condition occurs, immediately move the probe away from the patient and stop use of the probe. The probe is vulnerable to damage by impact. Therefore, handle it with care. There is a risk of damage to the probe when the probe is fallen or hit somewhere. Do not use this probe with other equipment except for those specifically approved in the manual. Use with unapproved equipment can result in an electric shock, burn, or other injury to the patient or operator and damage to the probe and the other equipment. Scan for the minimum length of time necessary for the diagnosis and at the lowest suitable output. Overuse can adversely affect the internal tissues of the patient. For details about the acoustic output, please refer to the documentation supplied with the ultrasound diagnostic instrument.

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MN1-0833 Rev. 25 Regularly perform maintenance inspection and safety tests of the ultrasound diagnostic instrument and probe. If you use equipment for a long period of time, it can reduce the performance, or cause smoke or fire. If anything unusual occurs, immediately stop using it and contact one of our offices and/or distributor's offices listed on the back cover. Use, move and transport the probe under the environmental conditions specified in this manual. Otherwise, it may be damaged. See section 2-5 "Environmental conditions" and section 7-4 "Environmental conditions during transportation".

1-2-2. Cleaning, disinfection and sterilization precautions

Warning Wear protective gloves and other protective gear during cleaning, disinfection and sterilization. Handling of the probe with your bare hands before disinfection or sterilization can result in an infection. After soaking in cleaning agents, thoroughly wash the probe with running water. Residual cleaning agents can cause an adverse reaction on the bodies of the operator or patient. After soaking in a disinfectant, throughly wash the equipment with deionized water. Leavings of the disinfectant can cause an adverse reaction on the bodies of the operator or patient. Perform aeration completely after gas disinfection and sterilization. Residual gas can cause an adverse reaction on the bodies of the operator or patient. Do not clean, disinfect or sterilize using procedures other than those specified in this manual. Infection could result due to incomplete cleaning, disinfection and sterilization. It can also result in damage to the probe or reduced performance. The probe cannot withstand autoclave sterilization or boiling and other types of sterilization at temperatures exceeding 60°C (140°F). For details on the usage conditions of chemicals and sterilization procedures, refer to the documentation supplied with the respective chemical or sterilization equipment. Infection could result due to incomplete disinfection or sterilization. This could also cause deterioration of the probe.

Caution Do not place the probe tip in any liquids beyond the range shown in the figure right. Use when liquid has gotten inside the connector can result in a risk of electric shock to the operator or patient. If liquid gets inside the connector, immediately stop use and contact one of our offices and/or distributor's offices listed on the back cover.

Water or chemical solution

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MN1-0833 Rev. 25 (2) Storage case

Label A

Label B

Label C

Label A

㻞㻙㻝㻢㻙㻝㻘㻌㻴㼕㼓㼍㼟㼔㼕㻙㼁㼑㼚㼛㻘㻌㼀㼍㼕㼠㼛㻙㼗㼡㻘㻌㼀㼛㼗㼥㼛㻘㻌 㻝㻝㻜㻙㻜㻜㻝㻡㻘㻌㻶㼍㼜㼍㼚㻌㻌㻌㼀㻱㻸㻌㻗㻤㻝㻙㻟㻙㻢㻞㻤㻠㻙㻟㻢㻢㻤

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Model Serial No. Manufacturer Address Rx Only: By prescription only. U.S. Federal Law restricts this device to sale on order of a physician only.

MN1-0833 Rev. 25 Label B

This instrument complies with Directive 93/42/EEC relating to Medical Device and Directive 2011/65/EU relating to RoHS.

IPX7

IPX7 mark See section 2-2, “Specifications”. Type BF applied part Do not waste the instrument as general waste. Comply with a local regulation. See section 10. STERRAD® sterilization compatibility mark See section 5.

Safety warning sign Biohazard See section 5. Follow the instruction manual to operate this instrument. If not avoided, may result in injury, property damage, or the insturments trouble.

Label C

Hitachi Medical Systems GmbH Otto-von-Guericke-Ring 3 D-65205 Wiesbaden, Germany

2016-09 P-3258F

This instrument complies with Directive 93/42/EEC relating to Medical Device and Directive 2011/65/EU relating to RoHS.

2016-09

DATE OF MANUFACTURE (in case of 2016-09) MANUFACTURER AUTHORISED REPRESENTATIVE IN EUROPEAN COMMUNITY

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2. Specifications and Parts name 2-1. Principles of operation This probe is used for blood stream image diagnosis using the continuous wave Doppler of ultrasonic wave. This equipment operates with the ultrasound diagnostic instrument under the principles described below. (1) This probe composed by one pair of the transmitting transducer and the receiving transducer. (2) The ultrasound diagnostic instrument applied electric signal to the probe, the transmitting transducer converting electric signal to mechanical vibration energy for emitting ultrasonic waves in to the human body contacting the ultrasonic irradiation area. (3) The emitted ultrasonic waves are reflected by boundaries with different acoustic characteristics (acoustic impedance) within the human body. (4) The reflected ultrasonic waves reached to the probe, the receiving transducer converting mechanical vibration energy to the electric signal and send the converted electric signal to the ultrasound diagnostic instrument as the echo signal. (5) The echo signal observed from the blood stream has the information of direction and velocity of the blood stream. The ultrasound diagnostic instrument given the frequency analyzing for the echo signal, and display the continuous wave Doppler images.

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2-2. Specifications

Application regions: Form of application to patient: Connectable instruments:

Circulatory organs Surface SSD- α5, SSD- α10, Prosound α 7, Prosound α 6, Prosound F75 SSD-4000, F37,ARIETTA 70, ARIETTA 60, ALOKA ARIETTA 850, ALOKA LISENDO 880

NOTE: At the time of publication of this manual, the connectable diagnostic ultrasound instrument or instrument software version available with this probe is different for each country, please refer to the instrument instruction manual or contact your local Hitachi representative.

Frequency: Cable length: Weight: Service life:

2.0 MHz 2.0 m 165 g Three years

Range of applied part Parts treated as applied parts IPX7 range

Ultrasonic irradiation area, see the section 2-4. Probe tip itself and 1 m of the cable near the probe tip. As shown in the figure below.

External dimensions:

As shown in the figure below.

9

127

IPX7 range

50

Cable length

67

14

Remarks The dimensions and weight are within ±10% of the indicated values.

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Unit: mm

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2-3. Performance

For measurement tolerances, operating tolerances and other data, refer to the instruction manual for the ultrasound diagnostic instrument.

2-4. Name of each parts Probe tip This area is held during operation.

Cable This cable propagates the ultrasonic signals that are sent and received.

Connector This is the part that connects the ultrasound diagnostic instrument and probe. Follow the instructions in section 4-2. Ultrasonic irradiation area This incorporates an transducer.

Caution Do not pull, bend, twist, or apply excessive force to the cable. The conductors may break and the cable may become unusable. Do not subject the ultrasonic irradiation area to hard impact. This could make the probe unusable.

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2-5. Environmental conditions

Use and store the probe under the following conditions.

2-5-1. Operating environmental conditions Ambient temperature:

Relative humidity: Atmospheric pressure: Altitude:

10°C to 40°C 50°F to 104°F 30% to 75% 700 hPa to 1060 hPa 3,000 m or less

2-5-2. Storage environmental conditions Ambient temperature:

Relative humidity: Atmospheric pressure:

–10°C to 50°C 14°F to 122°F 10% to 90% 700 hPa to 1060 hPa

Caution Avoid operating or storing the probe in the following locations. • Locations exposed to water or other liquids • Locations subject to adverse conditions such as air pressure, temperature, humidity, ventilation, direct sunlight, dust, or air containing salt, sulfur, or other corrosive substances • Locations where chemical substances are stored or where gases are generated Storage in these locations can result in a breakdown or reduced performance. Avoid rapid temperature change which may cause condensation. Avoid using in locations where condensation or water droplets can form. Condensation can occur when moving the probe from a cool location to a warm one. Use when condensation has occurred can result in a breakdown or reduced performance.

2-6. Classification of ME equipment • • • •

Classification based on degree of protection against electric shock.. Type BF applied part Classification for protection against ingress of liquids... IPX7 (Watertight equipment) Operation mode... Continuous operation Method of sterilization... See section 5 “Cleaning, disinfection and sterilization” For the range of applied parts, parts treated as applied parts and the range of IPX7, see section 2-2.

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3. Preparations for Use 3-1. Start up check 3-1-1. Visual check

Visually check the probe tip, ultrasonic irradiation area, cable and connector. If any holes, indentations, abrasion, cracks, deformation, looseness, discoloration, or other abnormalities are found, do not use the equipment.

3-1-2. Verification of cleaning, disinfection and sterilization

Verify that cleaning, disinfection and sterilization are conducted according to the intended use.

3-1-3. Verification of operation

Connect to the ultrasound diagnostic instrument by following the instructions in section 4-2, “Connecting to the ultrasound diagnostic instrument" and check that the selected probe match the doppler display and the displayed frequency and check the image for errors. Remarks For details on the displayed screens, see the documentation supplied with the ultrasound diagnostic instrument.

Warning Be sure to preparations for use. Using the probe without noticing an abnormal condition can result in injury to the operator or patient. If an inspection finds an abnormal condition in the probe, immediately stop use and contact one of our offices and/or distributor's offices listed on the back cover.

Caution Do not use the probe if the selected probe and image do not match the frequency. An incorrect acoustic output can result in burns or other injuries to the patient. Contact one of our offices and/or distributor's offices listed on the back cover.

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4. Usage 4-1. Operation

Bring the ultrasonic irradiation area of the probe into contact with the skin surface. Continuous wave Doppler image of the region of interest is displayed on the monitor of the ultrasound diagnostic instrument. For details on displaying and adjusting the screens, see the documentation supplied with the ultrasound diagnostic instrument.

Caution Do not move the probe with excessive force. Pressing down with more force than necessary can cause injury to the patient. Scan for the minimum length of time necessary for the diagnosis and at the lowest suitable output. There is the possibility that the patient’s internal tissues could be affected. For details about the acoustic output, please refer to the documentation supplied with the ultrasound diagnostic instrument. Do not touch the connector terminal pin of the probe. The probe may deteriorate or be damaged due to electrostatic discharge. Do not touch the electronic probe connecting socket of the diagnostic instrument and the patient at the same time. It can cause electric shock to the patient.

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4-2. Connecting to the ultrasound diagnostic instrument The locking ring of the connector moves in the range of the right figure and the ring is pushed towards the figure arrow mark with the spring. The connecting to the ultrasound diagnostic equipment are performed where the locking ring is pulled to a cable side. Connect the probe to the electronic probe connecting socket of the ultrasound diagnostic instrument ( probe connector ) by following the procedure below.

Locking ring

Movable range

• Connection procedure The probe is connected when in one of the following states. • The power switch is set to OFF. • The image displayed on the ultrasound diagnostic instrument is frozen. Before inserting the probe into the probe connector, check that the connector pins are not bent.

1. Pull the locking ring of the connector toward the cable and fit the pin position to the pin hole position of the ultrasound diagnostic instrument.

2. Firmly insert the connector into the probe connector on the ultrasound diagnostic instrument.

3. Release the locking ring and make sure that the locking ring has returned to the original position.

4. Make sure that the connector and the probe connector are tightly locked. This completes connection of the probe.

Note If you try to insert the connector in the connecting plug without fitting the pin hole position, it may damage them.

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4-3. Removing from the ultrasonic diagnostic instrument Use the procedure below to remove the probe from the probe connector of the ultrasound diagnostic instrument.

• Removal procedure The probe is removed when in one of the following states. • The power switch is set to OFF. • The image displayed on the ultrasound diagnostic instrument is frozen.

Pull the locking ring of the connector toword the cable and pull it out from the probe connector of the ultrasound diagnostic instrument.

This completes the removal of the probe. After use, perform cleaning, disinfection and sterilization of the probe by following the procedure in section 5 “Cleaning, disinfection and sterilization". If the probe will not be used for an extended period of time, store it by following the instructions in section 6 “Storage".

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