Essential Performance; Emc Statement - Mackworth TX600 User Manual

1.9 Essential Performance

The essential performance of the Hoist is defined as:
Raise up, lower down, traverse left, and traverse right and emergency lower.
These functions may be interrupted if the Hoist is subjected to any electromagnetic field created by other electrical devices
which are located nearby.
In the event of electromagnetic disturbances, the following conditions may occur:
1. Should the display screen go blank, or become unreadable, but eventually self recovers and there is detrimental effect
to performance, continue to use but investigate source of electromagnetic disturbance.
2. Should the display screen go blank, or the charging status bulb continue to flash red or green, the Hoist is still
acceptable to be used, but investigate EMC source and contact your service provider at the soonest opportunity.
3. Should the motors pause temporarily, the Hoist can be continue to be used but investigate EMC source and contact
your service provider at the earliest convenience.
1.10

EMC Statement

The following statement has been made against the assumption that the user of the system utilises the provided components
supplied by the manufacturer of the device to operate the device as intended. DO NOT use any other form of power charge with
the system as the manufacturer's adapter has been assessed and complies with the EMC requirements.
This product, has been designed, manufactured and tested in accordance with the legal requirements for the environment in
which the device will be used within.
Pacemakers, defibrillators and other medical devices should be manufactured in such a manner that they can withstand
Electromagnetic Interferences (EMI) in accordance with their associated mandatory European directives and regulations. Please
consult the user alert card which would have been issued to the user regarding the use of electrical items for those individuals
fitted with these or any other devices.
If users of this equipment are unsure of its compliance to EMC you can request the confirmation from Mackworth that the
product is manufactured to the appropriate Electromagnetic Compatibility standard.
A brief summary of the tests carried out in accordance with IEC 60601-1-2 is shown below in Table 3.
The Hoist is also classified as Class B according to CISPR 11:2009 for the home health care environment.
The use of the device within the correct area where the intended use is given will have no detrimental effect on other devices
that have been tested to their intended respective requirements.
Section Specification
Clause
Configuration and Mode: Test setup standby
2.1 4.4.1
2.2 5
Configuration and Mode: Test setup charging
2.3 7.1.1
2.4 7.1.1
999674 – Revision B
Test Description
General Requirement; Risk
Management Process for ME
Equipment and ME Systems
Identification, Marking and documents
Mains Terminal Disturbance Voltage
Electromagnetic Radiation Disturbance
Results Comments/ Base Standard
Pass
Pass
Pass CISPR 11: 2009 A1:2010 EN
55016-2-3: 2004 + A1:2005
Pass CISPR 11: 2009 A1:2010
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