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510(k) Data Aggregation
K Number
K040735Device Name
ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
Manufacturer
ALM S.A.
Date Cleared
2004-05-21
(60 days)
Product Code
FSY, TSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ALM S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ALM X'Ten™ (X10) Surgical Light Systems with Energix™ Power Supply are intended to be used to provide visible illumination of the surgical area or the patient.
An optional "LEDinside" feature is available and produces lower intensity levels of illumination intended for minimally invasive surgeries, procedures and examinations.
The Energix™ Power Supply is intended for use with surgical light systems.
Device Description
The ALM X'Ten'M Surgical Light System is a new product designation intended to identify a family of surgical lights that will use a similar set of design principals as the Angenieux (AX) Series Surgical Light Systems. The primary predicate device focuses on comparisons to the Angenieux® AX10, which is the medium sized lighthead within the Angenieux® (AX) Series.
The ALM X'Ten™ Surgical Light provides a broadened set of features and options that include video camera and flat screen display capabilities, bulb failure indicator(s), and an ambient light mode ("LEDinside") as results from this redesign effort. The user can toggie from the Surgical Light mode to the Ambient Light mode via use of a keypad switch mounted on the yoke of the lighthead. The "LEDinside" mode presents a ring of light mouthed from the bottom surface of the light, centered on the outer periphery of the sterile handle. Intensity can be adjusted to four levels: 30, 70, 110 and 150 Lux (@ 1m) and is sufficient to work on the patient in a dim or darkened operating room.
The ALM X'Ten™ Product Family currently has four configurations available, as shown within Table 1.
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K Number
K040015Device Name
MODIFICATION TO PRISMALIX SURGICAL LIGHT
Manufacturer
ALM S.A.
Date Cleared
2004-01-21
(16 days)
Product Code
FSY
Regulation Number
878.4580Why did this record match?
Applicant Name (Manufacturer) :
ALM S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ALM S.A. PrismAlix® (PRX) Surgical Lights with Energix™ Power Supply are intended to be used to provide visible illumination of the surgical area or the patient. The Energix™ Power Supply is intended for use with surgical light systems.
Device Description
The PrismAlix® (PRX) Surgical Light System is an existing product line that will allow modification via the use of an updated Energix™ Power Supply as its means to control the surgical lighthead illumination levels. The updated Energix™ Power Supply contains software that enables additional features and capabilities not available on the earlier version of Energix™ Power Supplies. These include:
- a) The power supply and regulators,
- b) one or two touch-pad units that provide the user the ability to:
- i) turn on/off one or two lightheads,
- ii) adjust illumination intensity levels and
- iii) additional Light Emitting Diodes (LEDs) are used to indicate:
- (1) the illumination level,
- (2) bulb failure sensing and
- (3) power supply mode: Mains supply: green LED or the switching to a battery back-up system results in the LED indicator changing its color to red.
An optional RS232 Communication Motherboard is also a new feature that allows shifting An optional ROZOE Ochinanicaa specified distance (50m, 164 ft.) away from the surgical Controls to a romote bite are provided specific user and maintenance type information/data, displayed on a Liquid Crystal Display (LCD) window located on the front information and the Energix™ power supply. The user also has an option to have data communicated to a personal computer (PC).
The LCD can show information about preventive maintenance type items, including:
- 1. programming of maintenance inspections
- 2. storage of operating parameters
- 3. hours of operation
- 4. bulb life data
- 5. self-diagnosis information
- 6. direct reading of parameters voltage, current, temperature
- 7. traceable management data serial number, software version number, production and service dates)
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