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(CPAP Diamedica) BUBBLE POSITIVE PRESSURE REGULATOR s.p.BC01

https://unicat.msf.org/cat/product/69737
STD EEMDCPAA601

Valid Article

Single patient multiple use A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
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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(CPAP Diamedica) BUBBLE POSITIVE PRESSURE REGULATOR s.p.

Definition

Single patient use positive end expiratory pressure valve for use with infant patients weighing < 10 Kg in hospital environments to increase end lung pressure above atmospheric in constant flow conditions.

Specifications

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Technical specifications

  • 60° Swivel inlet connector
  • 15M and 22F expiratory circuit connectors
  • Rotating pressure adjustment lever
  • Water level adjustment port allows water to be added or removed without disconnecting the expiratory circuit
  • Pressure range 0 - 10 cm H2O, Accuracy ± 1.0 cm H2O
  • Gas flow range 1 to 12 LPM
  • Material Polypropylene, polyethylene and silicone rubber
  • Operating temperature 10°C to 44°C (50°F to 111°F)
  • Storage temperature -40°C to 60°C (10°F to 140°F)
  • Single patient use

Packaging & Labelling

Supplied in box of 12 pieces

Instructions for use

The PAP Valve is installed at the end of an expiratory limb in a
continuous gas flow system to provide back pressure within the system.

The PAP valve is only for use with premature infants and infants < 10 kg (about 24 pounds)

Read carefully the instructions for use

Precautions for Use

  • PAP therapy may have an adverse effect on cardiopulmonary status.
  • Always monitor, maintain and verify PAP level with a manometer that measures proximal airway pressure.
  • Read and understand the contents of this insert and demonstrate proficiency in the application of this device prior to use.
  • The product is intended to be used by qualified medical personnel trained in pulmonary ventilation and advanced cardiac life-support techniques.
  • This PAP Valve has not been tested for use during Magnetic Resonance Imaging (MRI). However, this device does not contain any ferrous material. The use of the PAP Valve during MRI procedures may result in the failure of the device, blurring of the image, or misinterpretation of the image.
  • Do not attempt to disassemble the Valve as it will damage the components.
  • Single-patient use, do not reuse, soak, rinse, or sterilize PAP Valve with chemicals as these procedures may leave harmful residues and may impede the function of the PAP Valve.

Maintenance

Single-patient use, do not reuse, soak, rinse, or sterilize PAP Valve with chemicals as these procedures may leave harmful residues and may impede the function of the
PAP Valve.

MSF requirements

Consumable for the CPAP of Diamedica

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