Hitachi C25P - General Information; Intended Use and Application; ME Equipment Classification; Standard Components List

-1-
MN1-5821 Rev. 4
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 and 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. Specications 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. Classication of ME equipment
This probe is classied 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.
• Classication based on the degree of protection against electric shock
........
Type BF applied part
• Classication 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 C25P probe are as follows.
C25P Probe ··························································· 1 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-5821) ········································ 1 copy
• Safety (MN1-5982) ················································ 1 copy
• Cleaning, Disinfection and Sterilization (MN1-5998) ······ 1 copy