Patient's Safety - Saadat DENA 650 User Manual

Patient's safety

Introduction
The DENA 650 electrocardiograph device is designed to comply with the international safety standards
requirements for medical electrical equipment. This device has floating input (isolated electricity) and is
protected against the effects of defibrillation. If correct electrodes are used in accordance with the
manufacturer instructions, the display screen will recover within 10 seconds after defibrillation.
Grounding
To protect the patient and hospital personnel, the electrocardiograph system must be grounded. The DENA
650 is equipped with a detachable 3-wire cable which grounds the instrument to the power line ground
(protective earth) when plugged into an appropriate 3-wire receptacle. If a 3-wire receptacle is not available,
consult the hospital electricians. If there is any doubt regarding the integrity of the protective grounding
wire, the equipment should run on the battery.
WARNING

DENA 650 is intended to be used only by qualified medical staff.

Before use, carefully read this manual and directions for use of any accessories.

DENA 650 is intended for use only as an adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms.

There could be hazard of electrical shock by opening the system casing. All servicing and future
upgrading to this equipment must be carried out by personnel trained and authorized by
manufacturer.

The operator must check that the DENA 650 and accessories function safely and see that it is in
proper working condition before being used (e.g. Date of the last calibration must be valid).

Do not touch the patient, bed or devices nearby during defibrillation.

When defibrillator is used, the signals may be disturbed for a few seconds, after which the device
will continue to operate normally.

For people who have a pacemaker, be sure to enable the pacemaker detection feature on the
device.

The physician shall consider all well-known side-effects when using DENA 650 .
Patient's safety
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