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THORACIC SUCTION PUMP (Medela Thopaz+)

https://msf.oodin.sh/cat/product/72950
NST EEMDTHSE11-

Valid Article

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.
IIb
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
UN3481
Hazardous materials and products (identified by their 4-digit transport UN-number) must be transported under certain conditions as specified in the MSDS sheet (Material Safety Data Sheet).
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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THORACIC SUCTION PUMP (Medela Thopaz+)

Definition

An electrically-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure specifically for aspiration of the pleural cavity and/or mediastinum. It is a dedicated device intended to remove fluids (e.g., blood), secretions, and air to allow for the normal expansion/function of the lungs. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., catheter).

Specifications

Thopaz+ is a portable chest drainage system from Medela, Switzerland. The device delivers regulated individualized suction and continuously monitors and records air leakage and fluid loss. Thopaz+ is equipped with a suction pump, a digital display, a rechargeable battery, standard chest tube adaptors and disposable collection canisters.

  • Compact, portable vacuum source
  • Regulated pressure at the patient's chest
  • Digital display of air leak, fluid and pressure
  • Notifications on system status and Catheter patency indicator
  • Data recording and transfer to PC
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Technical specifications

  • Power supply: 100-240VAC, 0,8-0,4A, 47-63Hz.
  • A digital display provides data in real time as well as a 24-hour graph of the air leak
  • Low vacuum
    • 10 kPa
    • 75 mmHg
    • 100 mbar/cmH2O
  • Low flow 5 l/min

Thopaz+ can be operated from the mains power supply, from the docking station or with the integrated lithium-ion battery (< 10 Wh).

Dimensions

Weight: 1 kg

Transport Dangerous Goods

  • UN3481 Lithium ion batteries contained in equipment
  • Class: 9
  • Packing Instructions: 967 Section II
  • The label must include the UN code of the battery + an emergency number to contact in case of an incident
  • Limit per package:
    • Pax A/C (Passengers & Cargo Aircraft) = 5 kg
    • CAO (Cargo Aircraft Only) = 5 kg
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Instructions for use

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MSF requirements

Small, easy-to-use medical equipment designed to drain air and fluid from the pleural space, or chest, allowing the lung to re-inflate. Patients may undergo chest drainage, for example, after lung resection or because of a pneumothorax.

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Description approved by referent of OCB (Jonathan Delchambre) in August 2023.