Hitachi L441 User manual

i
MN1-5825 Rev. 4
L441 Probe
Instruction Manual
Specication
MN1-5825 Rev. 4
Notes for operators and responsible maintenance personnel
★
Please read through this Instruction Manual as well as the separate Instruction
Manual “Safety (MN1-5982)” and “Cleaning, Disinfection and Sterilization
(MN1-5998)“ carefully prior to use.
★
Keep this Instruction Manual together with the ultrasound diagnostic instru-
ment for any future reference.
© Hitachi, Ltd. 2014, 2017. All rights reserved.

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MN1-5825 Rev. 4

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MN1-5825 Rev. 4
Introduction
This is the instruction manual for L441 probe. The probe is available by connecting to Hitachi's ultrasound diagnostic
instrument and can be mainly used for observation of general abdominal organs.
Prior to use, read this manual as well as the separate instruction manual “Safety” in which information for safe use is
provided.
The probe bears the CE mark but the mark is valid only when the probe is connected to the ultrasound diagnostic
instrument bearing the CE mark.
Symbols used in this document
Safety information is classied into Danger, Warning, Caution, and Note according to the level of hazard. Those terms
are used in safety information provided to prevent hazards and injuries to the operator or patient.
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 that attention is required.
This symbol means that the described action is prohibited.
This symbol means that the described action is mandatory.

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MN1-5825 Rev. 4
This instruction manual contains 4 pages of front matter and 12 pages of the main content.
1. General Information...................................................................................................................................1
1-1. Intended use...................................................................................................................................................................1
1-2. Classication of ME equipment....................................................................................................................................1
1-3. Standard components ....................................................................................................................................................1
1-4. Options ..........................................................................................................................................................................2
2. Specications and Parts name....................................................................................................................3
2-1. Specications.................................................................................................................................................................3
2-1-1.Specication of the probe ................................................................................................................................3
2-1-2.Specications of the holding adjunctive equipment* ......................................................................................4
2-2. Name of each parts........................................................................................................................................................5
3. Preparations before use .............................................................................................................................7
3-1. Visual check ..................................................................................................................................................................7
3-2. Conrmation of cleaning, disinfection, and sterilization.............................................................................................7
3-3. Operation check.............................................................................................................................................................7
4. Operation....................................................................................................................................................9
4-1. Operation.......................................................................................................................................................................9
4-2. How to attach the holding adjunctive equipment .......................................................................................................10
4-3. How to release the holding adjunctive equipment ......................................................................................................11
4-3-1. Removing from the probe .............................................................................................................................11
4-3-2. Cleaning the holding adjunctive equipment................................................................................................. 11

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MN1-5825 Rev. 4
1. General Information
General information for the probe is provided below.
1-1. Intended use
This probe is intended to be used by doctors or other qualified operators. The probe is placed on the body for
observation 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 2-1. Specications of this manual.
Warning
Do not use this equipment for other than its intended use.
Otherwise it could cause burns or other injuries to the operator or the patient.
1-2. Classication of ME equipment
This probe is classied as follows according to IEC60601-1.
Please refer to the section 2-1 for the applied part, the part treated as the applied part, and the range of IPX7.
• Classication based on the 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 sterilization.................................................................................... Refer to the separate instruction manual
“Cleaning, Disinfection and Sterilization”
1-3. Standard components
The standard components of L441 probe are as follows.
L441 Probe ··························································· 1 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-5825) ······································· 1 copy
• Safety (MN1-5982)················································ 1 copy
• Cleaning, Disinfection and Sterilization (MN1-5998) ······ 1 copy

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MN1-5825 Rev. 4
1-4. Options
The following options are available for L441 probe.
• Puncture
Please use the options listed in Table 1 for performing a puncture. Regarding the usage of CIVCO Bracket, please
refer to the documentation supplied with the bracket.
Table 1 Options for puncture
Product Name Product No.
CIVCO Bracket 644-076
CIVCO Probe cover / Biopsy needle guide set 610-608
• Elastography
Please use the options listed in Table 2 for performing Elastography.
Table 2 Options for Elastography
Product Name Product No.
Hold adjunctive equipment MP-2804

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MN1-5825 Rev. 4
2. Specications and Parts name
The specications and the name of each part are provided below.
2-1. Specications
2-1-1.Specication of the probe
Application: Carotid artery
Type of patient contact: Surface
Connectable instruments: ARIETTA 70, ARIETTA 60, Noblus, ARIETTA Precision, ARIETTA
Prologue, 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.
Field of view: 38mm
Frequency: 6.0 MHz
Cable length: 2.0 m
Service life: 3 years
Applied part: Probe tip including ultrasonic radiation part, see the section 2-2
Part treated as Applied part: Cable up to 1 m length from the probe tip
IPX7 range: See Figure 1
Measurement accuracy: Refer to the instruction manual of the ultrasound diagnostic instrument
External dimensions: See Figure 1
Remark: The tolerance for the dimensions is ±10%.
Figure 1 External View
Unit: mm
24 55.1
96.8
Cable length
IPX7 range
50

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MN1-5825 Rev. 4
2-1-2.Specications of the holding adjunctive equipment*
* This equipment is the option of this probe.
Material Polyethylene
Service life Three years
External dimensions As shown in the gure below.
62
20
37
Unit:mm
Remark: The tolerance for the dimensions is ±10%.
Figure 2 External view of the holding adjunctive equipment
• Safety label
The meaning of each symbol in the safety label (Figure 3) is described in Table 3.
〔形名：P‑42123�Rev.00〕〔図番：MM〕
Figure 3 Safety label
Table 3 Mark and meaning of each symbol in the safety label
Mark Meaning
Safety warning sign
Biohazard
See the separate instruction manual “Cleaning, Disinfection and
Sterilization”.
Follow the instruction manual to operate this instrument.
Improper operation can result in injury, damage to property, or equipment
malfunction.

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MN1-5825 Rev. 4
2-2. Name of each parts
The name of each part is shown in Figure 4 and the explanation for each part is listed in Table 4.
Probe tip
Cable
Front mark
Ultrasonic radiation part Connector
Holding adjunctive equipment(Option)
Attachment holes
Figure 4 Name of each parts

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MN1-5825 Rev. 4
Table 4 Name of each part and its explanation
Name Explanation
Ultrasonic radiation part Ultrasound is radiated from this part. The electronic
linear transducer is integrated underneath this part.
Front mark The side of the front mark corresponds to the side of the
orientation mark on the image.
Probe tip This part is gripped during operation.
Cable Cable transfers electric input/output signals.
Connector The connector is the part which is connected to the
ultrasound diagnostic instrument.
holding adjunctive equipment
Attaching to the probe provides improved stability during
probe operation and enables easier vertical application to
the diagnosis region.
Follow the instructions in section 4-2.
Caution
Do not pull, bend, twist, or apply excessive force to the cable.
The probe may malfunction due to cable disconnection.
Do not subject the ultrasonic radiation part 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 radiation part itself is not damaged because the part is made of elastic
material.

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MN1-5825 Rev. 4
3. Preparations before use
This chapter describes preparations needed to use the probe safely. Please prepare the probe prior to each use by
following the instructions below.
3-1. Visual check
Visually check the probe tip, ultrasonic radiation part, cable, and connector.
If any holes, indentations, abrasion, cracks, deformation, looseness, discoloration, or other abnormalities are found, do
not use the probe.
Check also the options as necessary.
3-2. Conrmation of cleaning, disinfection, and sterilization
Conrm that the probe is certainly cleaned, disinfected, and sterilized. The degree of reprocessing depends on the
intended use. Please refer to the separate instruction manual “Cleaning, Disinfection and Sterilization“ for cleaning,
disinfection, and sterilization procedure. Check also that options are properly cleaned, disinfected, and sterilized.
3-3. Operation check
Connect the probe to the ultrasound diagnostic instrument and check that the displayed scan type and frequency
correspond to those of the probe. Check also that there is no abnormality in the image.
Remark: Please refer to the documentation supplied with the ultrasound diagnostic instrument for how to connect the
probe and information displayed on the monitor.
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
Make preparations prior to each use.
The operator and the patient may be injured if the equipment has any abnormality.
If any abnormality is found in the equipment, stop using it and contact our ofce written on the back
cover.
Caution
Do not use the probe if the displayed scan type and frequency do not correspond to those of the probe.
Incorrect acoustic output can result in burns or other injuries to the patient. Contact our ofce written
on the back cover.

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MN1-5825 Rev. 4

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MN1-5825 Rev. 4
4. Operation
This chapter describes the operation of the probe and how to attach/release the holding adjunctive equipment.
4-1. Operation
Place the ultrasonic radiation part of the probe onto the skin surface. An image of the region of interest is displayed
on the monitor of the ultrasound diagnostic instrument. For details on displaying and adjusting the image, refer to the
documentation supplied with the ultrasound diagnostic instrument.
Caution
Do not operate the probe with excessive force.
Use with excessive force could result in injury to the patient.
Scan for minimum time necessary at the lowest possible acoustic output.
Acoustic output may affect the patient’s internal tissues.
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.
Electrostatic discharge may result in malfunction of the probe.
Do not touch the probe connector of the ultrasound diagnostic instrument and the patient at the same
time. It can cause electric shock to the patient.

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MN1-5825 Rev. 4
4-2. How to attach the holding adjunctive equipment
Attach the holding adjunctive equipment to the probe as shown in the gure below.
Insert the probe into the holding adjunctive equipment by aligning the probe attachment guides with the attachment
holes in the holding adjunctive equipment and check that it is locked to the probe.
Probe attachment guide
Attachment holes
Before attaching After attaching
Figure 5 How to attach the holding adjunctive equipment

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MN1-5825 Rev. 4
4-3. How to release the holding adjunctive equipment
4-3-1. Removing from the probe
The holding adjunctive equipment is removed as shown in the gure below.
(1) Press one end of the holding adjunctive equipment to separate the attachment guide and
attachment hole on one side.
(2) Pull off and remove the probe from the holding adjunctive equipment.
①②
Figure 6 How to release the holding adjunctive equipment
4-3-2. Cleaning the holding adjunctive equipment
Immediately wash the holding adjunctive equipment immediately after it is removed from the probe.
Please refer to the separate instruction manual “Cleaning, Disinfection and Sterilization“ for cleaning,
disinfection, and sterilization procedure.
Note
After use of the equipment, immediately care of them.
If the equipment left in uncleaned for a long time after use, the adhered acoustic medium coagulate make
difcult to care the equipment.

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MN1-5825 Rev. 4
US Importer: Hitachi Healthcare Americas Corporation
Address: 1959 Summit Commerce Park, Twinsburg, Ohio 44087
Distributor
MN1-5825 Rev. 4 ’17.08.31
■Manufacturer
Hitachi, Ltd.
2-16-1, Higashi-Ueno, Taito-ku, Tokyo, 110-0015, Japan
■Contact
[phone]
http://www.hitachi.com/businesses/healthcare/index.html
Overseas Offices:
Hitachi Medical Systems GmbH
Otto-von-Guericke-Ring 3 D-65205 Wiesbaden, Germany
EU Importer: Hitachi Medical Systems Europe Holding AG
Address: Sumpfstrasse 13 CH-6300 Zug, Switzerland