Device Specifications; Intended Use; Contraindications - FHC Medtronic PH-2500 Gebrauchsanweisung

Package contents
Table 1. Package contents for Models PH-2500 and PH-2510
Model PH-2500
Passive Headrest
a
• Passive headrest:
- Front piece
- Back piece with a 4.45 cm
(1.75 in) diameter adapter for
the Mayfield starburst connector
• Pads (2)
• Straps (4)
• Product literature
The passive headrest and all accessories are supplied nonsterile. Clean both the front
a
and back pieces of the headrest after each use.

Device specifications

Table 2. Materials of components in the passive headrest package
Component
Headrest
Adapter for the Mayfield
starburst connector
Pads
Straps
Buckles
Indications for Use
The Headrest and accessories are part of the Nexframe Stereotactic System which
is intended to provide stereotactic guidance for the placement and operation of
instruments or devices during planning and operation of neurological procedures
performed in conjunction with the use of an image Guided Workstation System using
preoperative MR and/or CT imaging. These procedures include biopsies, catheter
placement and electrode introduction.

Intended Use

The Model PH-2500 Passive Headrest is intended for use to support the head and neck
during neurosurgical procedures while the patient is in the supine position.

Contraindications

None known.
L011-500-04 (Rev A0, 2019-08-27)
Model PH-2510
Passive Headrest Accessories
• Pads (2)
• Straps (4)
• Product literature
Material
Nylon, polyethylene,
thermoplastic, stainless steel
Polycarbonate
Open cell foam
Nylon
Nylon
a
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