Hitachi MXS2ESLL1 Probe User manual

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© Hitachi, Ltd. 2017. All rights reserved.
Tokyo, Japan
MXS2ESLL1 Probe
Instruction Manual
Specication
Notes for operators and responsible maintenance personnel
★Please read through this Instruction Manual as well as the separate Instruction Manual “Safety
(MN1-6105)” and “Cleaning, Disinfection and Sterilization (MN1-6117)” carefully prior to use.
★Keep this Instruction Manual together with the ultrasound diagnostic instrument for any future
reference.
MN1-6403 Rev. 1
DM# 126288 V1

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MN1-6403 Rev. 1
DM# 126288 V1

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MN1-6403 Rev. 1
Introduction
This is the instruction manual for MXS2ESLL1 probe. The probe is available by connecting to Hitachi’s ultrasound
diagnostic instrument and can be mainly used for observations of the heart.
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, and Caution 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.
War ning 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.
This symbol means that the described action is prohibited.
This symbol means that the described action is mandatory.
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MN1-6403 Rev. 1
CONTENTS
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 ..........................................................................................................................................................................1
2. Specications and Parts name....................................................................................................................3
2-1. Specications.................................................................................................................................................................3
2-2. Specications of the bite block .....................................................................................................................................4
2-3. Transducer cover ..........................................................................................................................................................4
2-4. Name of each parts .......................................................................................................................................................5
3. Preparations before use .............................................................................................................................7
3-1. Visual check ..................................................................................................................................................................7
3-2. Deection portion operation check ..............................................................................................................................7
3-3. Diagnostic image operation check ................................................................................................................................7
3-4. Verication of cleaning, disinfection and sterilization ................................................................................................7
3-5. Verication of operation ...............................................................................................................................................7
4. Operation....................................................................................................................................................9
4-1. Operation of the bite block............................................................................................................................................9
4-2. Transducer cover usage precautions .............................................................................................................................9
4-3. Insertion of Probe .......................................................................................................................................................10
4-4. Manipulation of Probe ...............................................................................................................................................11
4-5. Manipulation of the deection portion .......................................................................................................................13
4-6. Manipulation of the rotation switch...........................................................................................................................14
4-7. Manipulation of the Lock lever. ...............................................................................................................................15
4-8. Temperature Control System ......................................................................................................................................16
4-9. Removing the insertion portion ..................................................................................................................................16
4-10. Removal of transducer cover.....................................................................................................................................16
This instruction manual contains 4 pages of front matter and 20 pages of the main content.
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1. General Information
General information for the probe is provided below.
1-1. Intended use
This probe is intended for use by a doctor when inserted into the patient’s esophagus and its tip contacts the esophageal
wall making ultrasonic observations of the heart.
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.
War ning
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 MXS2ESLL1 probe are as follows.
MXS2ESLL1 Probe ················································· 1 set
Bite block SP-7901 ··················································· 2 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-6403) ······································· 1 copy
• Safety (MN1-6105) ··············································· 1 copy
• Cleaning, Disinfection and Sterilization (MN1-6117) ······ 1 copy
1-4. Options
The following options are available for this probe.
• Reprocessing by liquid detergent, disinfectant or sterilant
Whole the probe is able to immerge into the liquids by putting the connector of the ultrasound probe to the
waterproof case WP-001 as below table 1
Precautions about the waterproof case, please refer to the instruction manual.
Table 1 Accessory for reprocessing by liquid detergent, disinfectant or sterilant
Product Name Product No.
Waterproof case WP-001
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2. Specications and Parts name
The specications and the name of each part are provided below.
2-1. Specications
Application: Heart and thoracic aorta
Type of patient contact: Transesophageal
Connectable instruments: 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: 90°
Scan direction Any direction in 360° relative to insertion direction of insertion portion
Frequency: 4.0 MHz
Cable length: 1800 mm
Weight 110 0g
Service life: 3 years
Applied part: See Figure 1
Part treated as Applied part: See Figure 1
IPX7 range: See Figure 1
Measurement accuracy: Refer to the instruction manual of the ultrasound diagnostic instrument
External dimensions: See Figure 1
Maximum surface
Temperature of Probe tip 43℃
Figure 1 External View
Remarks
The dimensions and weight are within ±10% of the indicated values.
Unit: mm
Enlarged view of probe tip
(mm)
13.9
16.6
41
Range of applied part
Parts treated as applied parts
IPX7 range
cable length
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2-2. Specications of the bite block
Material Polyetherimide
Service life Three years
External dimensions As shown in the gure below.
40 33
50
Unit: mm
Remarks: The tolerance for the dimensions is ±10%.
Figure 2 External view of the bite block
2-3. Transducer cover
Use by covering the transducer cover over the insertion portion.
Transducer cover CIVCO Transducer cover 610-933
Remarks
The transducer cover is not included this probe-kit.
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2-4. Name of each parts
The name of each part is shown in Figure 2 and the explanation for each part is listed in Table 2.
Figure 3 Name of each parts
Insertion portion
Proximal head
Bite block
Connector
Deection portion
Rotation Switch A ,B
Cable
Angle knob for U/D defrection
Lock lever
Lock knob
Probe tip
Ultrasonic irradiation part
Angle knob for L/R defrection
Insertion part
Rotation Switch C
Ring
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Table 2 Name of each part and its explanation
Name Explanation
Ultrasonic irradiation part Ultrasound is radiated from this part. The electronic Sector
transducer is integrated underneath this part.
Probe tip This contains a temprature sensor controlling surface
temperature and a transducer.
Deection portion Operating the angle knob allows this part to be bent in any
desired direction.
Insertion portion The probe is inserted into the patient's body up to this section.
Angle knob for U/D defrection This part is used to UP/DOWN operate the deection portion.
Angle knob for L/R defrection This part is used to LEFT/RIGHT operate the deection portion.
Lock knob This part makes the angle knob for L/R defrection xed any
direction.
Lock lever
This part makes the angle knob for U/D defrection xed any
direction.
Proximal head
When using the probe, hold this part by hand.
Rotation Switch A ,B pushing this switches makes rotation of the diagnostic image.
Rotation Switch C pushing this switches makes rotation of the diagnostic image.
Cable Cable transfers electric input/output signals.
Connector The connector is the part which is connected to the ultrasound
diagnostic instrument.
Ring This part is used for hanging the proximal head
Bite block This is put in patient's mouth so that keep the path of the probe
inserted into the body
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 rubber
material.
Do not bend or twist the deection portion unnecessarily or manually .
This could make the probe unusable.
Keep the angle knob in the free position during an operation of curving.
Operating the probe while locked, it may become unusable.
There is no mark to indicate front direction of probe.
It becomes right axis angle operation, in Continuing pushing rotasion switch and completly turning
diagnostic image . See section 4-7.
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