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MN1-6131 Rev.3

1. General Information

General information for the probe is provided below

.

1-1. Intended use

This probe is intended to be used by doctors. It is placed in direct contact with human internal organs during surgery 
for ultrasonic observation. 
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. Specifications

 of this manual.

 Warning

Do not use this equipment for other than its intended use.

Otherwise it could cause burns or other injuries to the patient or operator.

1-2. Classification of ME equipment

This probe is classified as follows according to IEC60601-1.

Please refer to the section 2-1 for the range of applied part, the part treated as applied part, and the range of IPX7. 

•  Classification based on the degree of protection against electric shock

 ........ Type BF applied part

•  Classification 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 L53K probe are as follows.

L53K Probe  ··························································· 1 pc
Storage case ··························································· 1 pc
Instruction Manual

  • Specification (MN1-6131)

 ········································ 1 copy

  • Safety (MN1-5984)

 ··············································· 1 copy

  • 

Cleaning, 

Disinfection and Sterilization (MN1-6000) 

 ······ 1 copy

1-4. Options

• 

Reprocessing by liquid detergent, disinfectant or sterilant

The whole probe is able to be immerged into the liquids when the waterproof case WP-001 is attached to the probe.
Please refer to the instruction manual of WP-001 for details.

Accessory for reprocessing by liquid detergent, disinfectant or sterilant

Product Name

Product No.

Waterproof case

WP-001

Содержание L53K

Страница 1: ...nnel Please read through this Instruction Manual as well as the separate Instruction Manual Safety MN1 5984 and Cleaning Disinfection and Sterilization MN1 6000 carefully prior to use Keep this Instruction Manual together with the ultrasound diagnostic instru ment for any future reference Hitachi Ltd 2015 2017 All rights reserved ...

Страница 2: ...ii MN1 6131 Rev 3 ...

Страница 3: ...prevent hazards and injuries to the operator or patients Danger Indicates an imminently hazardous situation which if not avoided will result in death or serious injury to the operator or patient Warning 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 ...

Страница 4: ...mation 1 1 1 Intended use 1 1 2 Classification of ME equipment 1 1 3 Standard components 1 1 4 Options 2 2 Specifications and Parts name 3 2 1 Specifications 3 2 2 Name of each parts 4 3 Preparations before use 5 3 1 Visual check 5 3 2 Confirmation of cleaning and sterilization 5 3 3 Operation check 5 4 Operation 7 4 1 Operation 7 ...

Страница 5: ... part the part treated as applied part and the range of IPX7 Classification based on the degree of protection against electric shock Type BF applied part Classification 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 component...

Страница 6: ... 2 MN1 6131 Rev 3 ...

Страница 7: ...ocal Hitachi representative Field of view 25mm Frequency 8 5 MHz Cable length 3 0 m Service life 3 years Applied part See Figure 1 Part treated as applied part Cable up to 0 2 m length from the probe tip IPX7 range See Figure 1 In case that not putting the waterproof case to the ultrasound probe connector In case that putting the waterproof case to the ultrasound probe connector whole the probe fr...

Страница 8: ...the image Probe tip This part is gripped during operation Cable Cable transfers electric input output signals Connector The connector is the part which connects the probe and 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 im...

Страница 9: ...ect 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 brightn...

Страница 10: ... 6 MN1 6131 Rev 3 ...

Страница 11: ... not operate the probe with excessive force Use with excessive force could result in injury to the patient Scan for minimum time necessary at the lowest possible acoustic output Acoustic output may affect the patient s internal tissues For details about the acoustic output please refer to the documentation supplied with the ultrasound diagnostic instrument Do not touch the connector terminal pin o...

Страница 12: ...08 31 Manufacturer Hitachi Ltd 2 16 1 Higashi Ueno Taito ku Tokyo 110 0015 Japan Contact 81 3 6284 3668 http www hitachi com businesses healthcare index html Overseas Offices 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 ...

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