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MICROBIAL DECTECTION SYSTEM (BacT/ALERT 3D 60)

https://unicat.msf.org/cat/product/68055
STD ELAEMDSE2--

Valid Article

Former Code(s): ELAEZFR0783
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.
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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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BacT/ALERT 3D

Definition

The BacT/ALERT® 3D Microbial Detection System is an automated test system capable of incubating, agitating, and continuously monitoring aerobic and anaerobic media inoculated with patient specimens suspected of having bacteremia, fungemia, and/or mycobacteremia.

Specifications

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Quality Standards Comment

The BacT/ALERT ® 3D Microbial Detection System conforms to :

  • Relevant European regulations for electrical safety (UL-61010-1; IEC 61010-1; IEC 61010-2-081; CAN/CSA-C22.2 No. 1010.1-92);
  • Electromagnetic compatibility (EMC) regulations.

Components

The BacT/ALERT® 3D system includes a single instrument containing an incubation chamber, monitor, keyboard, UPS, printer, barcode reader, and a mouse.

  • BacT/Alert 3D 60: one incubation chamber containing 3 racks, each with a capacity of 20 culture blottles.
  • Bact/Alert 3D 120: capacity of 120 culture bottles (2 drawers).

Technical specifications

Power supply:

  • Rated AC voltage range: 100 - 240 V~, 50-60 Hz
  • Electrical ground required

Operational environmental parameters:

  • Operating temperature: 10°C to 30°C
  • Relative humidity: 10 to 90%, non-condensing
  • Altitude: 2000 meters

Storage:

  • Temperature: -17°C to 57°C
  • Relative humidity: 10 to 90%, non-condensing

Dimensions

BacT/ALERT 3D 60:

  • Width — 57.8 cm
  • Height — 61 cm
  • Depth — 49.5 cm
  • Weight (Unloaded) — 41 kg
  • Weight (Loaded) — 45 kg

Instructions for use

The following specimen types can be used in the system:

  • Blood
  • Sterile body fluids

Precautions for Use

  • All biological samples must be considered as potentially infectious and handled with the usual precautions (compulsory wearing of gloves, hand washing, etc.).
  • Once placed in the unit, handling of specimen bottle is not required until a result is obtained.
  • If microorganisms are present in the test sample, carbon dioxide is produced as the microorganisms metabolize the substrates in the culture medium. When growth of the microorganisms produces CO2, the color of the sensor in the bottom of each culture bottle changes from dark to light.

Maintenance

Routine BacT/ALERT ® 3D preventive maintenance is determined by your bioMérieux service program. There is no additional requirement for customer performed preventive maintenance. Contact your local bioMérieux Representative to schedule periodic service.

Waste management

After use, sterilize the cultures and all contaminated material.

MSF requirements

Must be validated by the laboratory referent

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