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OPERATING LIGHT (Mach LED150FP)+ ceiling fix., 35W, 2.6-3m

https://unicat.msf.org/cat/product/65940
STD EEMDLOPE33-

Valid Article

Former Code(s): EHOEZFR0861
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
Z12010701 - Fixed scialytic lamps
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
P
The order of this product needs to be justified and is only acceptable under certain conditions.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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OPERATING LIGHT (Mach LED150FP)+

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Definition

A device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It consists of an individual light head with more than one light source which include light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus.

Two possible support options:

  • Mobile mount designed to support an operating light that is used for medical purposes in the operating room (OR). This device is intended to be mobile (a mobile stand with wheels).
  • Ceiling-mounted with rotating arms allowing the positioning of the light to any position, in the operating room (OR). If the ceiling is higher than 3.00m an extension arm is required. This type should not be used if the ceiling is lower than 2.60m.

The model Dr Mach LED 150FP replaces the operating light Dr Mach LED 200F, which is no longer produced.

Synonym

Specifications

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Quality standards

EN IEC 60601-2-41, 2021, Medical electrical equipment - Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

Components

For the mobile lamp

  • 1 LED head with main control board (on/off switch + light intensity control) containing:
    • 1 Holder ring with glass
    • 1 Power adapter (power supply 60W)
    • 1 Control board (on/off switch + light intensity control)
  • 4 autoclavable handles ref. 21150002
  • 1 mobile stand with 4 legs with castors ref. 74975004

For the ceiling mounted lamps

  • 1 Mach LED 150FP Ceiling
  • 1 Ceiling anchorage ring 300 mm diam ref. 1500000270
  • 4 autoclavable handles ref. 21150002
  • Additionnal item for the height between 3.00m to 3.50m : 1 x Extension arm 3m to 3.5m ref 9050310350
  • Additionnal item for the height between 3.50m to 4.00m: 1 x Extension arm 3.5m to 4m ref. 9050310400

Technical specifications

  • Light source: LED
  • Light intensity: 125 000 lux / 1 m
  • 95 % daylight
  • Focusable light field: 14 to 22 cm diameter
  • Number of LED's: 26
  • Power supply: 230 V AC, 50/60 Hz, 1.66 Amp
  • Consumption: 35 W

Dimensions

  • Height mobile stand: 1.88 m with length arm 0.805 m. Height light head: 0.9-2.08 m
  • Ceiling mounted: length arms 0.75 + 0.91 m, for height ceiling: maximum 3.00 m
  • Ceiling height 3.00 - 3.50 m: additional extension arm required
  • Ceiling height 3.50 - 4.00 m: additional extension arm required

To be Ordered Separately

  • LED head main control board ref. 31090201
  • Holder ring with glass ref. 72000099
  • Fuse T2.OA ref. 67370005
  • Power adapter (60W) ref. 67010414
  • Control board (on/off, light intensity control) ref. 14117002
  • Sterilizable handle ref. 21150002

Instructions for use

See instructions manual.

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Precautions for Use

Secure the electrical protection of the apparatus with a double conversion UPS (see related articles below).

Maintenance

After each intervention, handles should be pre-disinfected, cleaned and sterilized by steam autoclave.

(Cf Introduction: Disinfection and sterilization in the field)

Storage

  • Temperature between -10° and +50°C
  • Relative humidity: between 20 and 90%
  • Air-pressure: 700-1060hPa

Waste management

The OT-lamp and its packaging contain no dangerous goods.

The electronic circuit boards should be recycled according to the appropriate procedures.

Other parts should be disposed of in accordance with recommendations for their specific materials.

MSF requirements

It is advised to have 2 operating lamps in each operating room.

In case the operating room is not planned for temporary use, mounting a (second) ceiling operating lamp can be considered together with the logistic and medical coordinator. This facilitates disinfection of operating room floor and increases space for staff to move around.

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