General Information; Classification Of Me Equipment; Standard Components - Hitachi S31KP Instruction Manual

1. General Information

General information for the probe is provided below.
1-1. Intended use
This probe is intended for use by a doctor when 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 4-7.
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 parts 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 S31KP probe are as follows.
Probe
Puncture adapter
Needle stopper
Depth gause
Storage tray
Adjustment hexagon screwdriver
Storage case
Instruction manual
• Specification
• Safety
• Cleaning, Disinfection and Sterilization
S31KP ...................................................................1 set
MP-2450-MB ........................................................1 set
MP-2477 ................................................................1 set
MP-2450-DG ........................................................1 piece
MP-2698 ................................................................1 set
...............................................................................1 piece
...............................................................................1 set
MN1-5831..............................................................1 copy
MN1-5986 .............................................................1 copy
MN1-6000 .............................................................1 copy
-1-
MN1-5831 Rev.5 MN1-5831 Rev.5
Cleaning, Disinfection and Sterilization"