General Information; Intended Use; Classification Of Me Equipment; Standard Components - Hitachi CC41R1 Instruction Manual

Probe
Table of Contents

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1. General Information

General information for the probe is provided below.

1-1. Intended use

This probe is intended to be used by a doctor or other qualified operator for ultrasonic observations of the prostate,
uterus, and surrounding organs. It can also be used for ultrasound-guided puncture.
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 operator or the patient.

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

1-3. Standard components

The standard components of
CC41R1 Probe ······················································· 1 pc
Storage case ··························································· 1 set
Instruction Manual
• Specification (MN1-6264) ······································· 1 copy
• Safety (MN1-5990) ··············································· 1 copy
• Cleaning, Disinfection and Sterilization (MN1-6161) ······ 1 copy
CC41R1
probe are as follows.
"Cleaning, Disinfection and Sterilization"
-1-
MN1-6264 Rev.2

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