Hitachi ASU-1014 User manual

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Notes for operators and responsible maintenance personnel
★
Please read through this Instruction Manual carefully prior to use.
★
Keep this Instruction Manual together with the ultrasound diagnostic instru-
ment for any future reference.
© Hitachi, Ltd. 2013, 2017. All rights reserved.
Electronic Convex Sector Scanner
ASU-1014
Instruction Manual
M N1-5933 Rev.5

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MN1-5933 Rev.5

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MN1-5933 Rev.5
This is an instruction for model ASU-1014, an ultrasound scanner.
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 scanner indicates that this scanner is valid when it is connected to equipment
bearing the CE mark that is specied as available in section 2 of this document. Therefore, if a
scanner bearing the CE mark is connected to equipment that is specied 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 efciently.
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.
Introduction

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MN1-5933 Rev.5
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. Specications and Parts name....................................................................................................................9
2-1. Principles of operation ..................................................................................................................................................9
2-2. Specications ..............................................................................................................................................................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. Classication of ME equipment .................................................................................................................................12
3. Preparations for Use .................................................................................................................................13
3-1. Start up check ..............................................................................................................................................................13
3-1-1. Visual check ..................................................................................................................................................13
3-1-2. Verication of cleaning, disinfection and sterilization ................................................................................13
3-1-3. Verication of operation ...............................................................................................................................13
4. Usage........................................................................................................................................................15
4-1. Operation.....................................................................................................................................................................15
4-2. Connecting to the ultrasound diagnostic instrument .................................................................................................16
4-3. Removing from the ultrasound 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
5-5. Manual cleaning and disinfection ..............................................................................................................................24

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MN1-5933 Rev.5
This Instruction Manual contains the main body of 40pages and 5pages until the CONTENTS.
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. Liquid sterilization (USA only)...................................................................................................................30
5-12. Storage .......................................................................................................................................................................30
6. Storage ..................................................................................................................................................... 31
6-1. Actions before storing the scanner..............................................................................................................................31
6-2. Environmental conditions for storage.........................................................................................................................31
7. Moving and Transporting.........................................................................................................................33
7-1. Moving and transporting.............................................................................................................................................33
7-2. Preparing the scanner and accessories for moving.....................................................................................................33
7-3. Packing for transportation...........................................................................................................................................33
7-4. Environmental conditions during transportation .......................................................................................................33
8. Periodic Inspection...................................................................................................................................35
8-1. Safety tests...................................................................................................................................................................35
8-2. Testing of measurement tolerances.............................................................................................................................36
8-2-1. Conducting tests ...........................................................................................................................................36
8-2-2. Result judgement ..........................................................................................................................................36
9. Conguration ...........................................................................................................................................37
9-1. Standard conguration................................................................................................................................................37
10. Disposal of the Device............................................................................................................................39

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MN1-5933 Rev.5

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MN1-5933 Rev.5
1. Safety Precautions
1-1. Intended use
This scanner is intended for use by a doctor or other qualied operator when placed into direct contact with
the skin making ultrasonic observations of surrounding organs.
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 efciently.
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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MN1-5933 Rev.5
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 scanner.
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 scanner while failing to notice an abnormal condition can result in injury to the operator
or patient. If any abnormalities are noted on the scanner in the start up inspection, immediately stop
using it and contact one of our ofces and/or distributor's ofces 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 scanner 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 scanner.
Electric shock or other unforeseen accidents could result. Contact one of our ofces and/or distributor's
ofces listed on the back cover to request repair.
Clean, disinfect and sterilize before using the scanner.
Perform proper cleaning, disinfection and sterilization after use.
Otherwise, there is a risk of infection. Note that the scanner is not sterilized at the factory.
Before using the scanner rst, 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 scanner used for patients with Creutzfeldt-Jakob disease.
Otherwise, there is a risk of infection to the operator or patient. Our scanner is not compatible with
any disinfection/sterilization method for Creutzfeldt-Jakob disease.
When using ultrasound contrast agent, follow the supplied documentation.
Unexpected accidents could result. Check the state of the patient and take appropriate precautions to
avoid side effects.
Do not use the scanner fallen on to oor.
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 scanner.
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
scanner away from the patient and stop use of the scanner.
The scanner is vulnerable to damage by impact. Therefore, handle it with care.
There is a risk of damage to the scanner when the scanner is fallen or hit somewhere.
Do not use this scanner with other equipment except for those specically 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 scanner and the other equipment.

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MN1-5933 Rev.5
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.
Regularly perform maintenance inspection and safety tests of the ultrasound diagnostic instrument
and scanner.
If you use equipment for a long period of time, it can reduce the performance, or cause smoke or
re. If anything unusual occurs, immediately stop using it and contact one of our ofces and/or
distributor's ofces listed on the back cover.
Use, move and transport the scanner under the environmental conditions specied 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 scanner with your bare hands before disinfection can result in an infection.
After soaking in cleaning agents, thoroughly wash the scanner 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 scanner 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.
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 specied in this manual.
Infection could result due to incomplete cleaning, disinfection and sterilization. It can also result in
damage to the scanner or reduced performance. The scanner cannot withstand autoclave sterilization
or boiling and other types of sterilization at temperatures exceeding 50°C (122°F).
For details on the usage conditions of chemicals procedures, refer to the documentation supplied with
the respective chemical equipment.
Infection could result due to incomplete disinfection. This could also cause deterioration of the
scanner.
Caution
Do not immerse the probe in any liquids beyond the range of IPX7 shown in section 2-2 "Specications".
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 ofces and/
or distributor's ofces listed on the back cover.

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MN1-5933 Rev.5
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
Label 3
Label 2
Label 1
Label 1
1-2-3. Labels
(1) Scanner unit
Electronic convex mark
Frequency

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MN1-5933 Rev.5
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
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.
Label2
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, “Specications”.
Type BF applied part
Do not waste the instrument as general waste. Comply with a
local regulation.
See section 10.
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
equipment trouble.
Label 3

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MN1-5933 Rev.5
Label A
(2) Storage case
Label B

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MN1-5933 Rev.5
Label A
Label B
Model
Serial No.
2016-09
DATE OF MANUFACTURE
(in case of 2016-09)
MANUFACTURER
AUTHORISED REPRESENTATIVE IN EUROPEAN
COMMUNITY
This instrument complies with Directive 93/42/EEC
relating to Medical Device and Directive 2011/65/EU
relating to RoHS.
2016-09
Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205
Wiesbaden, Germany
P-3258F

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MN1-5933 Rev.5

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MN1-5933 Rev.5
2. Specications and Parts name
2-1. Principles of operation
This scanner and the ultrasound diagnostic instrument enable image diagnosis using ultrasonic waves. These
instruments operate under the principles described below.
(1) When an electric pulse signal is applied from the transmitter to the transducer of the scanner, the
transducer operates by converting electrical vibrations to mechanical vibration energy for emitting pulse-
shaped ultrasonic waves into the body part contacting the transducer or into liquid or other medium.
(2) The emitted ultrasonic waves are reected by boundaries with different acoustic characteristics (acoustic
impedance) within the body.
(3) The transducer is also used to receive reected ultrasonic waves. The transducer vibrates mechanically
due to the received ultrasonic vibrations and uses an electro-mechanical conversion operation to
convert the received mechanical vibrations to electric energy. The received echo is also converted to
electric signals and a brightness modulation operation is used to convert the electric pulses to shades of
brightness for forming an image.
(4) The transducer is moved mechanically to enable changing of the scanning surface for sliced images.

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MN1-5933 Rev.5
Remarks
The dimensions and weight are within ±10% of the indicated values.
2-2. Specications
Application regions: Obstetrics areas
Form of application to patient: Surface
Connectable instruments: F37
Electronic scan field of view: 67°
Mechanical scan eld of view: Max 75°
Frequency: 5 MHz ± 30%
Cable length: 2.3 m
Weight: 1,250 g
Service life: Three years
Range of applied part As shown in the gure below.
Parts treated as applied parts Scanner tip itself and 1 m of the cable near the scanner tip.
IPX7 range As shown in the gure below.
External dimensions: As shown in the gure below.
Unit: mm
Cable length
50
IPX7 range
163
6943
Range of applied part

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MN1-5933 Rev.5
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
Scanner 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
scanner. Follow the instructions in
section 4-2.
Front mark
This protrusion indicates the direction
of the front mark (direction mark) on
the image display
Ultrasonic irradiation area
This incorporates an electronic
convex 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.
The impact may cause damage to the transducer, and that results in noise or no echo in the image.
In most cases, the ultrasonic irradiation area itself is not damaged because the part is made of plastic
material.

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MN1-5933 Rev.5
2-5. Environmental conditions
Use and store the scanner under the following conditions.
2-5-1. Operating environmental conditions
Ambient temperature: 10°C to 40°C
50°F to 104°F
Relative humidity: 30% to 75%
Atmospheric pressure: 700 hPa to 1060 hPa
Altitude: 3,000 m or less
2-5-2. Storage environmental conditions
Ambient temperature: -10°C to 50°C
14°F to 122°F
Relative humidity: 10% to 90%
Atmospheric pressure: 700 hPa to 1060 hPa
Caution
Avoid operating or storing the scanner 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 scanner from a cool location to a warm one. Use when
condensation has occurred can result in a breakdown or reduced performance.
2-6. Classication of ME equipment
• Classication based on degree of protection against electric shock . Type BF applied part
• Classication for protection against ingress of liquids ..................... IPX7 (Watertight equipment)
• Operation mode ................................................................................. Continuous operation
• Method of disinfection ......................................................................
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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MN1-5933 Rev.5
3. Preparations for Use
3-1. Start up check
3-1-1. Visual check
Visually check the scanner 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. Verication of cleaning, disinfection and sterilization
Verify that cleaning, disinfection and sterilization are conducted according to the intended use.
3-1-3. Verication 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 scanner match the
convex display and the displayed frequency and check the image for errors.
Verify that there are no abnormal vibrations or noise.
Remarks
For details on the displayed screens, see the documentation supplied with the ultrasound diagnostic
instrument.
If the probe is operated in still air, brightness on the top of the image may be non uniform, but this
does not affect the performance of the probe.
Warning
Be sure to preparations for use.
Using the scanner without noticing an abnormal condition can result in injury to the operator or
patient. If an inspection nds an abnormal condition in the scanner, immediately stop use and contact
one of our ofces and/or distributor's ofces listed on the back cover.
Caution
Do not use the scanner if the selected scanner 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
ofces and/or distributor's ofces listed on the back cover.

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MN1-5933 Rev.5