General Information; Intended Use; Classification Of Me Equipment; Standard Components - Hitachi MXS2ESLL1 Probe 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 inserted into the patient's esophagus and its tip contacts the esophageal
wall making ultrasonic observations of the heart.
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 MXS2ESLL1 probe are as follows.
MXS2ESLL1 Probe ················································· 1 set
Bite block SP-7901 ··················································· 2 set
Storage case ··························································· 1 set
Instruction Manual
• Specification (MN1-6403) ······································· 1 copy
• Safety (MN1-6105) ··············································· 1 copy
• Cleaning, Disinfection and Sterilization (MN1-6117) ······ 1 copy

1-4. Options

The following options are available for this probe.
• Reprocessing by liquid detergent, disinfectant or sterilant
Whole the probe is able to immerge into the liquids by putting the connector of the ultrasound probe to the
waterproof case WP-001 as below table 1
Precautions about the waterproof case, please refer to the instruction manual.
Table 1 Accessory for reprocessing by liquid detergent, disinfectant or sterilant
DM# 126288 V1
Product Name
Waterproof case
"Cleaning, Disinfection and Sterilization"
Product No.
WP-001
-1-
MN1-6403 Rev. 1