Hitachi L44LA - General Information; Intended use; Classification of ME equipment; Standard components

-1-
MN1-6013 Rev.4
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 into direct contact with human internal organs through the
trocar during surgery making ultrasonic observations.
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.
War ning
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 range of applied part, the part treated as 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 L44LA probe are as follows.
L44LA Probe ························································· 1 set
Protect tube(MP-2485B) ············································ 1 set
Storage case ··························································· 1 set
Instruction Manual
• Specication (MN1-6013) ······································· 1 copy
• Safety (MN1-5984) ··············································· 1 copy
• Cleaning, Disinfection and Sterilization (MN1-6000) ······ 1 copy
1-4. Options
There is no option available for L44LA probe.