English; Device Description - FHC Medtronic PH-2500 Manual Del Usuario

English

Explanation of symbols on package labeling
WARNING/Caution, consult instructions for important cautionary
information.
Consult instructions for use.
European Conformity. This device fully complies with MDD Directive 93/42/
EEC and legal responsibilities as a manufacturer are with FHC, Inc., 1201Main
Street, Bowdoin, ME 04287 USA.
Authorized Representative in the European Community.
Medical device manufacturer, as defined in EU Directives 90/385/EEC, 93/42/
EEC, and 98/79/EC.
Caution- Federal law (USA) restricts this device to sale by or on the order of
a physician.
In reference to "Rx only" symbol; this applies to USA audiences only.
Indicates the batch code so that the batch or lot can be identified.
Indicates the catalog number so that the medical device can be identified.
Do not re-use; Intended for one use on a single patient, during a single
procedure.
Indicates the date when the medical device was manufactured.
Medtronic® is a registered trademark of Medtronic, Inc. Mayfield® is a registered trademark of SM USA, Inc.

Device description

The Model PH-2500 Passive Headrest (Figure 1) is used to provide a headrest for
patients in the supine position during neurosurgical procedures. The passive headrest
is limited to 10 uses and must be cleaned after each use.
The pads and straps used with the passive headrest are intended for "single use on a
single patient. " Additional pads and straps are available in the Model PH-2510 Passive
Headrest Accessories.
Front
4
Figure 1. Model PH-2500 Passive Headrest.
L011-500-04 (Rev A0, 2019-08-27)
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