Abbott MER3700, Руководство пользователя

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Merlin™ Antenna Specifications
The Merlin™ Antenna Model 3638 is Class I medical equipment 3 .
Mechanical
Length 5.0 cm (2.0 in)
Width 10.3 cm (4.0 in)
Height 15.3 cm (6.0 in)
Case material High-impact plastic
Electrical
Input power (mains) Powered by Merlin™ 2 PCS
Input voltage 5.0 V
Maximum power consumption 0.5 A
Merlin™ Antenna Cable
Cable to Merlin™ 2 PCS 2.9 m (9.5 ft)
Essential Performance
The Merlin™ 2 PCS communicates with implantable devices (Implantable Cardioverter-
Defibrillators (ICDs), pacemakers, Cardiac Resynchronization Therapy (CRT) devices, and
Implantable Cardiac Monitors (ICMs)). Communication enables operations such as programming,
and the sending and retrieval of data between the Merlin 2 PCS and the implanted device. The
Merlin 2 PCS provides access to the implantable device but does not provide therapy: all therapy
is delivered via the implantable device.
The Merlin 2 PCS provides visual and mechanical interfaces to medical professionals so that they
may assess patient conditions and the functioning of the implantable device.
As per the risk analysis, there have been no unacceptable risks identified in evaluating the clinical
functions of the product and associated risks. The following safety guidelines should be kept
under consideration:

During external interference, such as electromagnetic interference, the programmer will not
undergo any permanent damages that prevents it from communicating with the implantable
device, although the programmer display and communication speed may be affected. The
programmer is able to reestablish and recover display and communication speeds, either
automatically or with manual intervention, once the external interreference is removed.

The programmer is not expected to function if the unit is damaged.
NOTE: For single fault conditions, see Troubleshooting (page 18).
3 The Merlin 2 PCS, Merlin RF antenna, and Merlin PSA comply with IEC 60601-1 + A1: 2012, Ed 3.1, ANSI/AAMI ES60601-1:
2005/A1: 2012 in addition to UL60601-1: 2003, and CAN/CSA - C22.2 NO. 60601-1:14. (Inclusion of ANSI/AAMI ES 60601-
1:2005 does not infer acceptance of the standard by OSHA).