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MN1-6363 Rev. 1

Introduction

This is the instruction manual for SML44 probe. The probe is available by connecting to Hitachi's ultrasound 

diagnostic instrument and can be mainly used for observation of superficial organs. 

Prior to use, read this manual as well as the separate instruction manual “Safety” in which information for safe use is 
provided.  

The probe bears the CE mark but the mark is valid only when the probe is connected to the ultrasound diagnostic 
instrument bearing the CE mark.

Symbols used in this document

Safety information is classified into Danger, Warning, Caution, and Note according to the level of hazard. Those terms 
are used in safety information provided to prevent hazards 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 result in minor or moderate injury to 

the operator or patient, or property damage only.

 Note

Indicates a strong request concerning an item that must be observed in order to prevent damage or 

deterioration of the equipment and also to ensure that it is used efficiently.

The type of safety information is indicated by the symbols below.

 

This symbol means that attention is required.

 

This symbol means that the described action is prohibited.

 

This symbol means that the described action is mandatory.

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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