Safety Requirements

Classifications:

- Type of protection against electrical shock: Class I

- Degree of protection against electrical shock (Patient connection):Type BF equipment
- Degree of protection against harmful ingress of water: Ordinary equipment
- Degree of safety of application in the presence of a flammable anesthetic material with air
or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or nitrous oxide.
- Mode of operation: Continuous operation

Electromechanical safety standards met:

- IEC/EN 60601-1 Medical Electrical Eqiupment, Part 1General Requirements for Safety.
- IEC/EN 60601-1-1 Safety requirements for medicalelectrical systems.
- IEC/EN 60601-1-2 Electromagnetic compatibility -Requirements and tests.
- IEC/EN 60601-2-37 Particular requirements for the safety of ultrasonic medical diagnostic
and monitoring equipment.
- IEC 61157 Declaration of acoustic output parameters.
- ISO 10993-1 Biological evaluation of medical devices.
- UL 2601-1 Medical Electrical Equipment, Part 1 General Requirements for Safety.
- CSA 22.2, 601.1 Medical Electrical Equipment, Part 1 General Requirements for Safety.
Declarations;

This is CSA symbol for Canada and United States of

America

This is manufacturer’s declaration of product compliance

0123
with applicable EEC directive(s) and the European notified
body.

This is manufacturer’s declaration of product compliance

with applicable EEC directive(s).

This is GMP symbol for Good Manufacturing Practice of

Korea quality system regulation.
 READ THIS FIRST

Before asking for the product to be repaired, read this service manual thoroughly, learn how to
troubleshoot, and make sure you understand the precautions fully.
The repair of the system and the replacement of parts must be carried out by an authorized
dealer or the customer care department of MEDISON Co., Ltd.
The company is shall not be held liable for any injury and damage caused by not following this
warning.

For safe use of this systemproduct, you should read ‘Chapter 2. Safety’ in this manual, prior to
starting to useing this system.

Describes precautions necessary to prevent user hazards of great

DANGER
urgency. Ignoring a DANGER warning will risk life-threatening injury.

Used to indicate the presence of a hazard that can cause serious

WARNING
personal injury, or substantial property damage.

CAUTION Indicates the presence of a hazard that can cause equipment damage.

A piece of information useful for installing, operating and maintaining

NOTE
a system. Not related to any hazard.