General Information; Intended Use; Classification Of Me Equipment; Standard Components - Hitachi C42T Instruction Manual

1. General Information

General information for the probe is provided below.

1-1. Intended use

This probe is intended to be used by doctors. The probe is placed in direct contact with human internal organs during
surgery for ultrasonic observation.
This probe can also be used for neurosurgery application if our specified transducer cover is mounted on the probe.
Please note that this probe is not allowed to be used for neurosurgery application in Japan. Regarding the precautions for
neurosurgery applications, please refer to the section 4-4.
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

1-3. Standard components

The standard components of C42T probe are as follows.
C42T Probe ··························································· 1 set
Storage case ··························································· 1 set
Instruction Manual
• Specification (MN1-5823)········································ 1 copy
• Safety (MN1-5984) ··············································· 1 copy
• Cleaning, Disinfection and Sterilization (MN1-6000) ······ 1 copy
"Cleaning, Disinfection and Sterilization"
-1-
MN1-5823 Rev.6