Hitachi L34 Bedienungsanleitung

L34 Probe

INSTRUCTION MANUAL

--- For USA ---

Tokyo , Japan

Q1E-EP1441-2

©Hitachi,Ltd.2013,2016.Allrightsreserved.

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CONTENTS

1. Foreword ......................................................1

2. General caution ...............................................2

3. General .......................................................6

4. Probe Components List .........................................7

5. Accessories (Option) ..........................................7

5.1 Coupler Attachment EZU-PA3C1 ............................7

5.2 Coupler Attachment EZU-PA3C1H ...........................7

5.3 Coupler Attachment EZU-PA3C2 ............................8

6. External View .................................................9

7. Cleaning and sterilization/

high level disinfection of L34 ...............................10

7.1 Levels of Disinfection Requirement .....................10

7.2 Reprocessing Procedure .................................11

7.3 Cleaning Process .......................................12

7.4 Liquid Chemical Sterilization/Disinfection Process .....14

7.5 EtO Sterilization Process ..............................15

7.6 Plasma Sterilization Process ...........................16

8. Operating Procedure ..........................................17

8.1 Operation of the ultrasound diagnostic scanner .........17

8.2 Orientation of the image ...............................18

8.3 Probe Sheath ...........................................20

8.4 Diagnosis ..............................................20

8.5 Care after use .........................................20

9. Maintenance and Safety Inspection ............................21

9.1 Probe Care .............................................21

9.2 Daily Inspection .......................................21

10. Specifications ...............................................22

11. Supplier’s List ..............................................23

12. Disposal of the probe ........................................23

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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 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.

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1. Foreword

Before using the probe, carefully read this instruction manual for

correct and safe handling of the probe as well as for making the most

of the performances of the probe and the ultrasound scanner with which

the probe is to be used.

Notes to Users

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

the function, operating and maintenance instructions by thoroughly

reading and understanding this manual and the manuals that accompany

probes and accessories before operating this equipment, paying

particular attention to all warnings, cautions, and notes

incorporated herein. Please contact a service support if you have any

questions concerning the operation of equipment.

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.

NOTE: “Note” is used to notify people of installation, operation,

or maintenance information which is important, but not

hazard related.

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2. General caution

For safe use of the ultrasound scanner and probe, it is advisable

to strictly observe the following:

1) Federal law restricts this device to use by or on the order

of a physician.

2) Be sure to read and observe the “General Cautions in

Operation” stated in the operation manual for the ultrasound

scanner with which the probe is to be used.

3) The probe and ultrasound scanner with which it is used should

never be operated in an environment at a higher or lower

temperature, under a higher or lower pressure and a higher

humidity, than the specified operating ambient conditions.

(Also see the paragraph “10. Specifications”.)

4) Never try to remodel the probe and ultrasound scanner; if

they are remodeled, a fault will possibly be caused.

5) Do not use chemicals or organic solvents such as thinner for

wiping the probe. (See the paragraph “9.1 Probe Care”.)

6) Do not hit or drop the probe because the inside of the probe

head is easily broken by mechanical shocks.

7) Keep the probe head off substances containing fatty acid

(hydrocarbon of methane series, paraffin). Because it soaks

into the inside of the probe head through the surface of the

probe head and cause a fault.

8) If the ultrasound scanner and probe malfunction, contact our

service personnel.

9) The use of a sterile probe sheath is recommended with this

probe.

10) Use only sterilized acoustic gel during examinations in which

sterile techniques are used.

NOTE: The warranty period of the probes is one year from their

delivery to the user. If they become faulty within this period

and it is evident that Hitachi is responsible for the fault,

they will be repaired or replaced with normal ones free of

charge.

CAUTION

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NOTE: This warranty does not cover accidental damage on your site

or improper handling, such as wear, extreme temperature,

damages caused by chemical acids and solvents.

Because of reports of severe allergic reactions to medical devices

containing latex (natural rubber), the FDA is now advising

health-care professionals to screen their latex-sensitive patients,

and be prepared to treat allergic reactions promptly. Please read

and become familiar with the FDA Medical Alert report of March 29,

1991, titled, “Allergic Reactions to Latex-Containing Medical

Devices”, reprinted on the following pages.

In certain applications, the use of a protective sheath is

recommended. Because of the possibility of latex-sensitive

patients, Hitachi and HAMA are now recommending the use of non-latex

covers. Specifically, we are recommending that the end user utilize

the following devices:

Device: CIVCO PRO/CoversTM

Manufacturer: CIVCO Medical Instruments Company, Inc.

We recommend that the end user contact CIVCO directly for obtaining

sizing and pricing information, samples, and local distribution

information.

WARNING

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3. General

L34 Probe is of linear array type. This is designed for use as connected

with Hitachi Ultrasound scanner.

Clinical Intended Use

Please refer to the Instruction Manual (Supplement – Safety and

Effectiveness) of the scanner with which this probe is combined.

NOTE: Do not use this probe for a purpose out of the specified intended

use, and the intended use of this probe is limited each device.

Please contact your local Hitachi representative with any

question on this probe availabilities and intended uses.

Acoustic output

Please refer to the Instruction Manual (Supplement – Safety and

Effectiveness) of the scanner with which this probe is combined.

Clinical Measurement Accuracy

In case of using measurement function with this probe, please refer

to the Instruction Manual (Supplement – Safety and Effectiveness)

of the scanner with this probe is combined with regard to the clinical

measurement accuracy.

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4. Probe Components List

The components list of L34 is given in Table.1.

Table.1 Probe component list

Component Note

1 L34 Probe 1 piece

2 Instruction manual 1 copy

3 Shipping & storage box 1 set

5. Accessories (Option)

5.1 Coupler Attachment EZU-PA3C1

The components list of the EZU-PA3C1 is given in Table.2.

Table.2 Coupler attachment component list

Component Note

1 Coupler attachment 2 pieces

2 Instruction manual 1 copy

3 Case 1 piece

Please refer to the instruction manual of option about the method

of handling, cleaning and sterilizing the coupler attachment

EZU-PA3C1.

5.2 Coupler Attachment EZU-PA3C1H

The components list of the EZU-PA3C1H is given in Table.3.

Table.3 Coupler attachment component list

Component Note

1 Coupler attachment 2 pieces

2 Needle Guide * 2 pieces

3 Instruction manual 1 copy

4 Case 1 piece

* A 20-22 gauge biopsy needle is available inside the needle guide.

Please refer to the instruction manual of option about the method

of handling, cleaning and sterilizing the coupler attachment

EZU-PA3C1H.

DM 120918 v2

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