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CPAP, complete with 10l concentrator (Diamedica)

https://unicat.msf.org/cat/product/66967
STD EEMDCPAE6--

Valid Article

Former Code(s): EHOEZFR0860
Article is intended to be used with children (<12 years) ONLY.
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.
Z12030102 - Continuous positive pressure equipment
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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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, complete with 10l concentrator (Diamedica)

Definition

A mains electricity (AC-powered) device intended to assist noninvasive ventilation (i.e., without use of an artificial airway) of a neonatal/infant patient via an attached nasal cannula or mask, using continuous positive airway pressure (CPAP) during spontaneous respiration. It is a modified oxygen (O2) concentrator with additional features (e.g., adjustable flow rates and O2 concentration, humidification) which is used with Hudson prongs or nasal cannulas. It is primarily intended for use in a healthcare facility, especially in intensive and critical care settings.

Specifications

  • Self-contained unit, the Baby CPAP provides up to 95% oxygen
  • Twin flowmeters for up to 10 l/min oxygen and 10 l/min medical air
  • Humidifier ensures appropriate warmth and moisture for air and oxygen to be delivered to patient
  • Neonate bonnets: 2 sizes available
  • Silicone nasal prongs (Hudson prongs): 5 sizes available
  • Only in some circumstances the unidirectional cannulas (previously called RAM cannulas) can be used as an alternative (e.g. when it is difficult to keep the Hudson prongs in a correct position).
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Quality standards

ISO 80601-2-69, 2020, edition 2, Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment

Components

Part DescriptionDescription partieDiamedica CodeMSF Code
Oxygen concentrator 10lpmConcentrateur d'oxygène 10lpm//
Spigot 15M - 6-9mmConnecteur 15M - 6-9mm1702-1945EEMDCPAA622
Straight Connector Ø 22F - 15MStraight Connector Ø 22F - 15M1962000EEMDCPAA620
Humidifier bottleHumidificateurTR200EEMDCONA003
Bubble PAP valve bottleRégulateurpression à bullesBC01EEMDCPAA601
Sieve beds for 10lpm oxygen concentratorTamis pour concentrateur oxygène 10lpmBE186-1SEANEANAS520
Air RegulatorRégulateur d'air435-9609-MODEANEANAS513
Flowmeter flow regulatorRégulateur de débit492-8570-CPAPEEMDCPAS605
Oxygen regulatorRégulateur d'oxygène210-812-MODEEMDCPAS602
Foam filter 10l oxygen concentratorFiltre mousse concentrateur d'oxygène 10lFI002-1EEMDCONS502
Hepa filter for oxygen and air 10lpm concentratorFiltre Hepa filter pour concentrateur 10lpmFH5581EANEANAS518
Clear length tubing Ø 6mm 1m lengthTuyau transparent Ø 6mm longueur 1m686-2680-AEEMDCPAC625
Black length tubing Ø 6mm 1m lengthTuyau noir Ø 6mm longueur 1m721-4007-AEEMDCPAC626

Technical specifications

  • Oxygen Concentrator, twin flowmeter for up to 10 l/min oxygen and 10 l/min medical air – no external gas supply required
  • Maximum blended gas flow : 20 l/min
  • Oxygen flow capacity : 10 l/min
  • Air flow capacity : 10 l/min
  • Oxygen concentration : 21% - 95%
  • Pressure: 1 - 10 cm H2O. Set by the bubble controller
  • Power supply
    • Voltage: 220 – 240 VAC, 50 Hz
    • Power consumption: 312W
  • Alarms: power failure, low oxygen concentration, high & low pressure, no flow
  • 4 antistatic castors
  • The product is intended to be used in harsh environments (high humidity and temperature, dust, frequent power fluctuations and cuts)

Dimensions

  • 62 x 34 x 30 cm
  • Weight : 17 kg

Supplied with the Article

  • 1 oxygen concentrator 10L
  • 1 bubble PAP valve (pressure controller)
  • 2 sets inspiratory and expiratory tubing, autoclavable
  • 4 silicone nasal prongs
  • 2 neonate bonnets
  • fixing straps and chin straps
  • 1 humidifier bottle, autoclavable

To be Ordered Separately

Standard composition for a neonatal unit. Order the spare items in sufficient quantities!

MSF Code

Label

Ref.

Qty

EEMDCONA003

HUMIDIFIER, autoclavable (FLOWMETER TR200)

TR200

5

EEMDCPAC627

WATER TRAP, s.p.

1911

10

EEMDCPAA602

TUBE insp/exp w/ connector, s.p.

CPAP/SP3

100

EEMDCPAA601BUBBLE PAP VALVE BOTTLEBC015
EEMDCONS401(conc. DeVilbiss 525KS/1025KS) DUST FILTER 303DZ-605303DZ-6055
The following items are calculated for the use in a neonatal unit
EEMDCPAA616TIE BONNET smallCPAP/SP1/S15
EEMDCPAA617TIE BONNET MediumCPAP/SP1/M35
EEMDCPAC624CHIN LIFT, s.p. microN78510
EEMDCPAC615CHIN LIFT, s.p. smallN78620
EEMDCPAC616CHIN LIFT, s.p. largeN78710
Hudson prongs are currently the standard interfaces for the use of bubble CPAP
EEMDCPAC603NASAL PRONG, s.p. size 0B02010
EEMDCPAC604NASAL PRONG, s.p. size 1B02180
EEMDCPAC605NASAL PRONG, s.p. size 2B02280
EEMDCPAC606NASAL PRONG, s.p. size 3B02350
EEMDCPAC607NASAL PRONG, s.p. size 4B02410
EEMDCPAC630SILICONE NASAL TUBING + CONNECTORS s.p.CPAP/SNT300

The unidirectional cannulas should only be used in some circumstances

EEMDCPAC617

UNIDIRECTIONAL CANNULA, s.p. size 0

N4900-U

10

EEMDCPAC618

UNIDIRECTIONAL CANNULA, s.p. size 1

N4901-U

20

EEMDCPAC619

UNIDIRECTIONAL CANNULA, s.p. size 2

N49012-U

20

EEMDCPAC620

UNIDIRECTIONAL CANNULA, s.p. size 3

N49013-U20

Instructions for use

Bubble CPAP should only be used by trained and skilled clinical teams.

​If bCPAP is used, essential elements of good nursing and clinical care need to be provided by a dedicated team in an adequately staffed and equipped neonatal or paediatric intensive care unit.

It is recommended to have an oximeter with an infant/newborn probe for each CPAP set-up.

Hudson or nasal prongs are currently the standard interfaces for the use of bubble CPAP . They have to be ordered with the silicone nasal tubing for fixation.

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Precautions for Use

The units, in which bubble CPAP is used need to have reliable electricity supply, with adequate back-up systems in case of power cuts.

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

Maintenance

Daily/between each patient

Clean the device with with a detergent/disinfectant for surfaces/non-invasive medical equipment. Prepare use-solution in concentration required. Always read the label and product information before use. Do not mix with other products. Make sure to wet surfaces completely, use a wipe or towel, keep them wet for the whole exposure time.

Weekly

Clean dust filter (black filter at the back of the equipment) twice a week with soap and water

Every 3 months

  • Check if any abnormal noises
  • Check if displayed flow more or less equal to the flow set.
  • Check status and condition of the 9Volts battery. If necessary, replace it.
  • Replace long-term filter and remove dust from inside the equipment.
  • Perform trimestrial maintenance check (Read Maintenance protocol for further information)
  • Quality control with the 02 analyzer. (expected results: oxygen concentration > 88%)

Yearly

  • Replace antibacterial filter at the outlet of the equipment (inside)
  • Replace dust filter (black filter at the back of the equipment)

For further details on maintenance, protection and repair see specific documents.

MSF requirements

Infants and preterm babies in respiratory distress

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The following items are needed for the use of bCPAP on a paediatric unit in addition to the standard composition of the neonatal CPAP.

Extra Tables

MSF Code

LabelLibellé

Ref.

Qty

EEMDCPAA617​TIE BONNET MediumBONNET avec ATTACHES, medium​​CPAP/SP1/M20
EEMDCPAA623TIE BONNET LargeBONNET avec ATTACHES, largeCPAP/SP1/L35
EEMDCPAA624TIE BONNET Extra LargeBONNET avec ATTACHES,  extra largeCPAP/SP1/XL10
EEMDCPAC616CHIN LIFT, large s.p. FIXATEUR DU TUBE AU MENTON, p.u. largeN78710
EEMDCPAC605​NASAL PRONG, s.p. size 2CANULE NASALE, p.u. taille 2B022​10
EEMDCPAC606NASAL PRONG, s.p. size 3CANULE NASALE, p.u. taille 3B02320
EEMDCPAC607NASAL PRONG, s.p. size 4CANULE NASALE, p.u. taille 4B02430
EEMDCPAC608NASAL PRONG, s.p. size 5CANULE NASALE, p.u. taille 5B02580
EEMDCPAC609NASAL PRONG, s.p. size 6CANULE NASALE, p.u. taille 6B02680
EEMDCPAC610NASAL PRONG, s.p. size 7CANULE NASALE, p.u. taille 7B02730
EEMDCPAC630SILICONE NASAL TUBING + CONNECTORS s.p.TUBE NASAL SILICONE + CONNECTEURS p.u.CPAP/SNT300