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MN1-6363 Rev. 1

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. 
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 applied part, the part treated as the 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 SML44 probe are as follows.

SML44 Probe  ························································ 1 set
Storage case ··························································· 1 set
Instruction Manual

  • Specification (MN1-6363)

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

  • Safety (MN1-5980)

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

  • 

Cleaning, 

Disinfection and Sterilization (MN1-5998) 

 ······ 1 copy

Содержание SML44

Страница 1: ...nce personnel Please read through this Instruction Manual as well as the separate Instruction Manual Safety MN1 5980 and Cleaning Disinfection and Sterilization MN1 5998 carefully prior to use Keep this Instruction Manual together with the ultrasound diagnostic instru ment for any future reference Hitachi Ltd 2017 All rights reserved ...

Страница 2: ...ii MN1 6363 Rev 1 ...

Страница 3: ...zards 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 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 avoided may...

Страница 4: ...ns 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 disinfection and sterilization 5 3 3 Operation check 5 4 Operation 7 4 1 Operation 7 4 2 How to attach release the magnetic position sensor and the magnetic position sensor attachment 8 4 2 1 How to attach the magnetic position sensor 8 4 2 2 How to release ...

Страница 5: ...ies 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 applied part the part treated as the 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 Waterti...

Страница 6: ...for SML44 probe Real Time Virtual Sonography RVS Please use the option listed in Table 1 for performing RVS Regarding how to attach release the attachment please refer to the section 4 2 Table 1 Option for RVS Product Name Product No Magnetic Sensor Attachment RV 014 ...

Страница 7: ...s different for each country please refer to the instrument instruction manual or contact your local Hitachi representative Field of view 38mm Frequency 7 5 MHz Cable length 2 2 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 Refe...

Страница 8: ...mage 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 cau...

Страница 9: ...isinfected and sterilized 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 mon...

Страница 10: ... 6 MN1 6363 Rev 1 ...

Страница 11: ...sound diagnostic instrument Caution Do 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 ...

Страница 12: ...r Magnetic Position Sensor Attachment Align the direction Figure 3 How to attach Magnetic Position Sensor 2 Attach the magnetic position sensor attachment to the probe by sliding as shown in Figure 4 Please confirm that the projected part of the attachment and the front mark of the probe are aligned in the same direction Figure 4 How to attach Magnetic Position Sensor Attachment Caution Attach the...

Страница 13: ...position sensor attachment to release it from the probe as shown in Figure 5 Figure 5 How to release Magnetic Position Sensor Attachment 2 Take out the magnetic position sensor from the magnetic position sensor attachment as shown in Figure6 Figure 6 How to release Magnetic Position Sensor ...

Страница 14: ... only intended to be used for marking The scale of the Marking Assist does not correspond to the display scale and the width of the probe does not correspond to the image width displayed in the image see the Figure below Marking Assist The scale of the Marking Assist Display scale Not correspond The width of the probe does not correspond to the image width ...

Страница 15: ... 11 MN1 6363 Rev 1 This page intentionally left blank ...

Страница 16: ... 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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