Hitachi VC35 Probe Bedienungsanleitung

Tokyo, Japan

VC35 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

(MN1-5994)” and “Cleaning, Disinfection and Sterilization (MN1-6002)” carefully prior to use.

★Keep this Instruction Manual together with the ultrasound diagnostic instrument for any future

reference.

MN1- 6374 Rev. 0

MN1-6374 Rev. 0

iii

MN1-6374 Rev. 0

Introduction

This is the instruction manual for VC35 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, 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.

MN1-6374 Rev. 0

CONTENTS

1. General Information...................................................................................................................................1

1-1. Intended use...................................................................................................................................................................1

1-2. Classication of ME equipment....................................................................................................................................1

1-3. Standard components ....................................................................................................................................................1

2. Specications and Parts name....................................................................................................................3

2-1. Specications.................................................................................................................................................................3

2-2. Name of each parts........................................................................................................................................................4

3. Preparations before use .............................................................................................................................5

3-1. Visual check ..................................................................................................................................................................5

3-2. Conrmation of cleaning, disinfection, and sterilization.............................................................................................5

3-3. Operation check.............................................................................................................................................................5

4. Operation....................................................................................................................................................7

This instruction manual contains 4 pages of front matter and 8 pages of the main content.

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MN1-6374 Rev. 0

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.

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 VC35 probe are as follows.

VC35 Probe ··························································· 1 set

Storage case ··························································· 1 set

Instruction Manual

• Specication (MN1-6374) ······································· 1 copy

• Safety (MN1-5994) ··············································· 1 copy

• Cleaning, Disinfection and Sterilization (MN1-6002) ······ 1 copy

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MN1-6374 Rev. 0

-3-

MN1-6374 Rev. 0

2. Specications and Parts name

The specications and the name of each part are provided below.

2-1. Specications

Application: Obstetric and gynecological areas, Abdomen

Type of patient contact: Surface

Connectable instruments: ARIETTA 70

Electronic scan eld of view: 72°

Mechanical scan eld of view: 80°

Frequency: 4.0 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

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MN1-6374 Rev. 0

2-2. Name of each parts

The name of each part is shown in Figure 2 and the explanation for each part is listed in Table 1.

Figure 2 Name of each parts

Table 1 Name of each part and its explanation

Name Explanation

Ultrasonic radiation part Ultrasound is radiated from this part. The electronic

convex transducer is integrated underneath this part.

Front mark The side of the orientation 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.

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 plastic

material.

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MN1-6374 Rev. 0

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.

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.

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.

War ning

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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MN1-6374 Rev. 0

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