Hitachi VC34A Probe Bedienungsanleitung

VC34A Probe

INSTRUCTION MANUAL

Tokyo, Japan

Q1E-EP1398-4

Notes for operators and responsible maintenance personnel

★Please read through this Instruction Manual carefully prior to use.

★Keep this Instruction Manual together with the system with care to

make it available anytime.

0123

(1) Q1E-EP1398

Manufacturer: Hitachi, Ltd.

2-16-1, Higashi-Ueno, Taito-ku, Tokyo,110-0015,

Japan

+81-3-6284-3668

http://www.hitachi.com/businesses/healthcare/

index.html

European

Representative: 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

Local Distributor:

(2) Q1E-EP1398

About this manual

This instruction manual shall provide the procedure for inspection,

operation and reprocessing of VC34A Probe.

The manual also contains the general information and the specification

of the probe. The probe is usable with the HITACHI ultrasound diagnostic

scanner. The operation of the HITACHI ultrasound diagnostic scanner

shall be referred to its instruction manual.

To ensure safe operation, it is essential that you fully understand

the function, operating and maintenance instructions by thoroughly

reading and understanding this manual. Please contact a service support,

if you have any questions concerning the operation of the probe.

The following conventions are used throughout the manual to denote

information of special emphasis.

WARNING: “Warning” is used to indicate the presence of a hazard which

can cause severe personal injury, death, or substantial

property damage if the warning is ignored.

CAUTION: “Caution” is used to indicate the presence of a hazard which

will or can cause minor personal injury or property damage

if the caution is ignored.

NOTICE: “Notice” is used to notify people of installation,

operation, or maintenance information which is important,

but not hazard related.

(3) Q1E-EP1398

Graphical Symbols for Use in Labeling of Hitachi Ultrasound Probes

Some graphical symbols that are used in labeling of Hitachi Ultrasound Probes are

compliant with EN980:2008 standard. Refer to the following table about the meanings

of them.

Explanation of Symbol Symbol Descriptive Content

Manufacturer Company

Name and Address

Hitachi, Ltd.

2-16-1, Higashi-Ueno, Taito-ku,

Tokyo, 110-0015, Japan

+81-3-6284-3668

http://www.hitachi.com/businesses/

healthcare/index.html

Authorized

Representative

in The European

Community

Hitachi Medical Systems GmbH

Otto-von-Guericke-Ring 3 D-65205

Wiesbaden, Germany

Keep away

from Sunlight

Store the probe in a cool, dustproof, dark

and dry place and keep away from high

temperature, high humidity and direct

sunlight.

(4) Q1E-EP1398

Definition of symbol

The following symbol is also used for HITACHI Ultrasound Probes.

Location Symbol Definition

Probe connector

This instrument complies with Directive

93/42/EEC relating to Medical Device

and Directive 2011/65/EU relating to

RoHS

Probe connector IPX7 IPX7 mark

See section 1.5

Probe connector Type BF APPLIED PART

Probe connector General warning sign

Probe connector Warning; dangerous voltage

Probe connector Caution; Biohazard

Probe connector

Follow the instruction manual to

operate this instrument. If not

avoided, may result in injury, property

damage, or the equipment trouble.

Probe connector Do not waste the instrument as general

waste. Comply with a local regulation.

Probe connector Rx Only

By prescription only. U.S. Federal Law

restricts this device to sale on order

of a physician only.

(5) Q1E-EP1398

CONTENTS

Page

1. General ........................................................ 1

1.1 General..................................................... 1

1.2 Principles of operation..................................... 1

1.3 Intended Use................................................ 2

1.4 Components.................................................. 2

1.5 External View............................................... 3

2. Inspection before Use .......................................... 4

2.1 Inspection for Appropriate Connection....................... 4

2.2 Inspection for Material Surface............................. 4

3. Operation Procedure ............................................ 5

4. Reprocessing Procedure ......................................... 6

4.1 Point of use (Pre-cleaning)................................. 9

4.2 Containment and transportation.............................. 9

4.3 Manual Cleaning and disinfection............................ 9

4.4 Drying..................................................... 12

4.5 Inspection................................................. 12

4.6 Storage.................................................... 12

5. Maintenance and Safety Inspection ............................. 13

6. Safety Precautions ............................................ 14

7. Specifications ................................................ 15

7.1 Probe...................................................... 15

7.2 Suppliers List............................................. 16

8. Disposal of the probe ......................................... 17

-1- Q1E-EP1398

1. General

1.1 General

The model VC34A Probe is a convex array electronic scanning type.

The probe is capable of acquiring Real-time 3D image by mechanical

drive of the acoustic elements.

The acoustic output was measured with operating the Hitachi

Ultrasound diagnostic scanner according to IEC60601-2-37. The

measured acoustic output is listed in the instruction manual of the

Hitachi ultrasound scanner.

The probe is categorized in class IIa according to Directive

93/42/EEC and classified as type BF according to IEC60601-1.

1.2 Principles of operation

This probe and the ultrasound diagnostic scanner enable image

diagnosis using ultrasonic waves. This system operates under the

principles described below.

1) When an electric pulse signal is applied from the transmitter

to the transducer of the probe, the transducer converts electric

signals into mechanical vibration energy for emitting

pulse-shaped ultrasonic waves into the body part, liquid or other

medium contacting the transducer.

2) The emitted ultrasonic waves are reflected by boundaries with

different acoustic characteristics (acoustic impedance) within

the body.

3) The transducer is also used to receive reflected ultrasonic waves.

The transducer vibrates mechanically due to the received

ultrasonic waves and converts mechanical vibrations into

electric energy. Electric signals are converted to shades of

brightness by brightness modulation to obtain an image.

-2- Q1E-EP1398

1.3 Intended Use

VC34A Probe is designed for observation and diagnosis mainly of the

following regions by connecting with the Hitachi ultrasound

diagnostic scanner.

Fetal

Pediatric

Abdominal

Small organ

Never use the probe for following applications.

Direct contact to the heart.

Biopsy to the heart.

Direct contact to the eye

1.4 Components

The components of VC34A Probe are given below:

1) Probe ................................... 1 piece

2) Instruction manual ...................... 1 copy

3) Correct Backlash CD-ROM ................. 1 piece

The CD-ROM contains the probe’s specific parameters to be loaded

to the Hitachi ultrasound diagnostic scanner. Hitachi service

engineer installs the CD-ROM to the scanner. Store the CD-ROM in

a safe place.

WARNIN

-3- Q1E-EP1398

Disinfection has not been made to the probe, shipped from the

factory. Prior to use of the probe, be sure to clean and disinfect

the probe.

1.5 External View

The external view of VC34A Probe is shown in Fig. 1.

Immersible part (IPX7)

Scan head

Connector

Cable

Un-immersible part

Immersible part: This part can be immersed in disinfectant solution

and also can be cleaned by water.

Un-immersible part: This part should not be immersed in disinfectant

solution and also can not be cleaned by water.

Fig. 1 External view

Handle housing

Applied part

-4- Q1E-EP1398

2. Inspection before Use

Prior to use, the probe must be carefully inspected that it is

appropriate for use.

2.1 Inspection for appropriate connection

2.1.1 Confirm that the system is correctly operating. Refer to the

instruction manual for the ultrasound diagnostic scanner.

2.2 Inspection of material surface

2.2.1 Visually inspect the surface of the probe head, housing, the

cable and the connector for any crack, scratch or

denaturalization. If you find any damage, do not use the probe,

and immediately contact a service support.

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