Hitachi C22K Manual de usuario

C22KProbe

INSTRUCTIONMANUAL

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.

Tokyo,Japan

Q1E‐EP1389‐5



©Hitachi,Ltd.2013,2017.Allrightsreserved.

(1) Q1E-EP1389

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-EP1389

About this manual

This instruction manual shall provide instructions for using, cleaning,

and disinfecting and/or sterilizing the HITACHI ultrasound probes.

It also describes safety considerations, maintenance.

For instructions for operating the main unit, refer to the operation

manual for it.

Before using the probe, thoroughly read this manual and keep this book

for future reference.

If you have any questions concerning the manual, please contact a service

support.

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-EP1389

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 place and keep

away from high temperature, high humidity,

or direct sunlight.

(4) Q1E-EP1389

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 1.6.

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

STERRAD sterilization compatibility

mark

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-EP1389

CONTENTS

Page

1. General ······················································ 1

1.1 General ···················································· 1

1.2 Principles of operation ···································· 1

1.3 Intended Use ··············································· 1

1.4 Components ················································· 2

1.5 Option ····················································· 2

1.5.1 Puncture adapter (MP-2781) ······························ 2

1.5.2 Puncture adapter (MP-2781-5) ···························· 2

1.5.3 Puncture adapter (MP-2781-25) ··························· 2

1.5.4 CIVCO Bracket (CIV-614-108) ····························· 2

1.6 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. Cleaning, Disinfection and Sterilization ····················· 6

4.1 Point of use (Pre-cleaning) ································ 7

4.2 Containment and transportation ····························· 7

4.3 Manual Cleaning and disinfection ··························· 8

4.4 Drying ····················································· 9

4.5 Inspection ················································· 9

4.6 Packaging ················································· 10

4.7 Sterilization ············································· 11

4.8 Storage ··················································· 13

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

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

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

7.1 Probe ····················································· 15

8. Suppliers List ·············································· 15

9. Disposal of the probe ······································· 16

-1- Q1E-EP1389

WARNING

1. General

1.1 General

C22K Probe is a Convex Array Probe.

The acoustic output of this probe when connected to ultrasound scanner

was measured according to IEC 60601-2-37 standard.

The table of measured acoustic output data is contained in the operation

manual of each ultrasound scanner.

This probe is categorized in class IIa according to Directive 93/42/EEC.

According to IEC 60601-1 the probe is classified as type BF.

1) Never use the probe for following applications.

Direct contact to the heart.

Biopsy to the heart.

Direct contact to the eye

2) Never use the probe with (HF) surgical equipment.

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.

1.3 Intended Use

C22K Probe is designed for observation and diagnosis mainly of the

following regions by connecting with the HITACHI ultrasound scanner.

Intraoperative

-2- Q1E-EP1389

CAUTION

1.4 Components

The components of C22K Probe are given below:

1) Probe ····················· 1 piece

2) Instruction manual ········ 1 copy

Sterilization has not been made to the probe, shipped from the factory.

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

the probe.

1.5 Option

1.5.1 Puncture adapter (MP-2781)

1) Puncture adapter (MP-2781-MB) ··········· 1 set

2) Needle guide G18 (MP-2781-G18) ·········· 1 piece

3) Needle guide knob (MP-2781-KNO-B) ······· 1 piece

4) Adjustment hexagon screwdriver ·········· 1 piece

5) Instruction manual ······················ 1 copy

1.5.2 Puncture adapter (MP-2781-5)

1) Puncture adapter unit (MP-2781-5-MB) ···· 1 set

2) Adjustment hexagon screwdriver ·········· 1 piece

3) Instruction manual ······················ 1 copy

1.5.3 Puncture adapter (MP-2781-25)

1) Puncture adapter unit (MP-2781-25-MB) ··· 1 set

2) Adjustment hexagon screwdriver ·········· 1 piece

3) Instruction manual ······················ 1 copy

1.5.4 CIVCO Bracket (CIV-614-108)

Please refer to the instruction manual of option about the method of

handling, cleaning, disinfection and sterilization.

1) Sterilization has not been made to the MP-2781, MP-2781-5 and

MP-2781-25 shipped from the factory. Prior to use of them, be sure

to clean and sterilize them.

2) A biopsy should be performed only by a well-trained physician. Use

only the authorized puncture adapter for performing a biopsy.

-3- Q1E-EP1389

1.6 External View

The external view of C22K Probe is shown in Fig. 1.

Fig.

xternal View

Immersible part (IPX7)

Cable

Connector

Un-immersible part

pplied part

Immersible

part:

This part can be immersed in disinfectant

solution and also can be cleaned by water.

Un-immersible

part:

This

art should not be immersed in

disinfectant solution and also cannot be

cleaned by water.

-4- Q1E-EP1389

2. Inspection before Use

Prior to use, the probe must be carefully inspected that they are

appropriate for use.

2.1 Inspection for Appropriate Connection

1) Confirm that the system is correctly operating. Refer to the

instruction manual for the ultrasound diagnostic scanner.

2) Do not attach or connect unauthorized devices or instruments on the

probe, such as unauthorized biopsy attachments.

2.2 Inspection for Material Surface

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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