Infant T-Piece Resuscitator

Baby Start is a lightweight Infant T-piece resuscitator suitable both for delivery and post-delivery rooms, special care baby and neonatal intensive care units.

Current resuscitation guidelines(*) recommend use of a manual T-Piece device with a potential benefit of achieving fixed PIP targets and deliver consistent PEEP values to help establish acceptable FRC levels improving lung volume in newborns with respiratory issues.

Operated by an external gas source (Air/02) Baby Start is a user-friendly apparatus irrespective of experience, training and effort level applied providing the baby with suitable breath patterns.

The T-Piece includes an adjustable valve to achieve required PEEP level. This single-use adjustable T-Piece includes a respiratory tube and connections to the manual resuscitator. Baby Start is available both with a heated circuit suitable for Humidified Gas applications and non-heated circuit. Heated circuits are 1000/o compatible with “Wetty” GINEVRI humidifiers.

Resuscitation is executed applying a positive pressure through the use of a mask or an endotracheal tube by manual command and voluntary expiration. Neonatal resuscitation masks are easy to use and designed for complete face adhesion. These are available from GINEVRI in two sizes suited to fit any newborn.

Baby Start is available with an optional time counter to perform SUSTAINED INFLATION therapies, a prolonged continuous positive pressure gas supply is transferred to the respiratory system enabling a prompt recovery of respiratory functions. The counter aids operators by emitting acoustic signals every five, ten or fifteen seconds from activation.

Baby Start can be installed on various surfaces and GINEVRI equipment using a dedicated multipurpose mounting bracket, included an useful trolley (optional).

(*) – 201 5 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care – Part 13 Neonatal – resuscitation.
- 201 5 European Resuscitation Council Guidelines for Resuscitation – Section 7.
Resuscitation and Support of Transition of Baby at Birth.

• The choice of interface affects the efficacy of NIV.

• The pressures as measured by the ventilators (before the interface) are dependent on interface resistance are not equivalent to what is delivered to the lung

• Evaluation of a nasal cannula in noninvasive ventilation using a lung simulator. Iyer NP, Chatburn R.Respir Care. 2015 Apr;60(4):508-12.

• Neonatal nasal intermittent positive pressure ventilation efficacy and lung pressure transmission. Mukerji A, Belik J.J Perinatol. 2015 Sep;35(9):716-9.

• Tidal volume transmission during non-synchronized nasal intermittent positive pressure ventilation via RAM(®) cannula. Matlock DN, Bai S, Weisner MD, Comtois N, Beck J, Sinderby C, Courtney SE.J Perinatol. 2019 May;39(5):723-729.

SIZES :

NASALCANNULAØ2-L8mm with CPAP Holder & 25 cm Bonnet

NASALCANNULAØ2-L10mm with CPAP Holder & 25 cm Bonnet

NASALCANNULAØ3-L12mmwith CPAP Holder & 30 cm Bonnet

NASALCANNULAØ4-L14mmwith CPAP Holder & 35 cm Bonnet

INDICATIONS FOR USE

The PACTRYS®-NCA is a product intended for use on premature and newborn babies that require supplemental oxygen, respiratory support or assistance in breathing in an outpatient, hospital or institutional setting.

It is used for Non-invasive ventilation

INSTRUCTIONS FOR USE

Select an appropriately sized cannula.

Non Invasive Ventilation:

• For non-invasive ventilation (NIV) the cannulas must adhere completely to the wall of the nostrils so as it is snuggly fitted in nostrils.
• Connect CPAP Bubble Holder Set with Cannula & fix assembly with Bonnet.
• Connect the Bubble Holder set with gas source, making sure that all the connections are properly secured
• Open and test the gas flow level before placing the device on the patient.
• Insert the cannula into the patient’s nostrils and leave a small gap between the patient’s septum and the base of the cannulas.
• Replace the PACTRYS®-NCA every 7 days or according to the hospital protocol, whichever occurs first. Dispose of the used PACTRYS®-NCA according to hospital protocol.

TECHNICAL CHARACTERISTICS

• Soft and delicate interface
• Individually packaged
• Single use
• Made of high performance TPE suitable for medical use
• Connection: M15mm
• Dimensions: 4 sizes XXS, XS, S, M
• Class according to 93/42 EEC directive: IIa

Components of NASAL CANNULA ACCESSORIES

Nasal Cannula

Bonnet made up of 100% cotton with elasticity

Bubble CPAP Cannula Holder Set includes :

Y Connector With Water Condensation Line out

White Cap

Two Expandable Tubes (upto 70 cm- Ø10 F)

WARNINGS

• This device must be used only when the patient is under the continuous and direct supervision of the healthcare professional and frequent observation of the position of the cannula in the patient’s nostrils is necessary.

• Incorrect choice of size, improper placement or use can cause septal trauma or necrosis.

• The cannula tubes can represent a potential strangulation hazard.

• Always start the gas flow before inserting the cannula into the patient’s nostrils.

• Do not use if the package is damaged or opened.•        Do not immerse, wash or sterilize.

• Stop immediately if skin irritation occurs.

• For single patient use only.

• The device must be stored in a suitable, cool and dry place away from heat sources.

•  Avoid exposure to direct light sources.

• The product, if it comes into contact with it, has chemical-physical incompatibilities with organic solvents (petrol, benzoyl, esters, ketones, chlorine hydrocarbon).

 

TYPE	SIZE	OUTER DIAMETER(mm)	PRONGS LENGTH (mm)	BONNET SIZE
NASAL CANNULA	XXS	2	8	25 cm
NASAL CANNULA	XS	2	10	25 cm
NASAL CANNULA	S	3	12	30 cm
NASAL CANNULA	M	4	14	35 cm

• The choice of interface affects the efficacy of NIPPV.

• The pressures as measured by the ventilators (before the interface) are dependent on interface resistance are not equivalent to what is delivered to the lung

Evaluation of a nasal cannula in noninvasive ventilation using a lung simulator. Iyer NP, Chatburn R.Respir Care. 2015 Apr;60(4):508-12.

Neonatal nasal intermittent positive pressure ventilation efficacy and lung pressure transmission. Mukerji A, Belik J.J Perinatol. 2015 Sep;35(9):716-9.

Tidal volume transmission during non-synchronized nasal intermittent positive pressure ventilation via RAM(®) cannula. Matlock DN, Bai S, Weisner MD, Comtois N, Beck J, Sinderby C, Courtney SE.J Perinatol. 2019 May;39(5):723-729

CODE:

 13230A73 – FLOW CANNULA – XXS

 13230B73 – FLOW CANNULA – XS

 13230C73 – FLOW CANNULA – S

 13230D73 – FLOW CANNULA – M

 

INDICATIONS FOR USE

The Flow Cannula is a product intended for use on premature and newborn babies that require supplemental oxygen, respiratory support or assistance in breathing in an outpatient, hospital or institutional setting.

It is used for the following therapies:

1. Heated and humidified high flow oxygen therapy

2. Non-invasive ventilation, with heated or no-heated, humidified flow

INSTRUCTIONS FOR USE

Select an appropriately sized cannula using the size guide provided in the package.

High Flow Oxygen Therapy:

• For high flow oxygen therapy (HHHFNC): the cannula diameter must be 50% lower than that of the nostrils
• Connect the cannula to the oxygen source, making sure that all the cannula connections are properly secured
• Open and test the level of oxygen flow before placing the device on the patient
• Insert the cannula into the patient’s nostrils and leave a small gap between the patient’s septum and the base of the cannula

Non Invasive Ventilation:

• For non-invasive ventilation (NIV) the cannulas must adhere completely to the wall of the nostrils, without creating pressure or stretching of the skin
• Connect the cannula to the gas source, making sure that all the cannula connections are properly secured
• Open and test the gas flow level before placing the device on the patient.
• Insert the cannula into the patient’s nostrils and leave a small gap between the patient’s septum and the base of the cannulas.
• Replace the FLOW CANNULA every 7 days or according to the hospital protocol, whichever occurs first. Dispose of the used cannula according to hospital protocol.

TECHNICAL CHARACTERISTICS

• To be used with low / high flow humidified oxygen
• Soft and delicate interface
• Individually packaged
• Single use
• Made of high performance TPE suitable for medical use
• Connection: M15mm
• Total weight: about 16g
• Dimensions: 4 sizes XXS, XS, S, M
• Class according to 93/42 EEC directive: IIa

GENERAL INFORMATIONS

Cannula in TPE

Tube in medical PVC

Connector M15

Latex free

DEHP free

WARNINGS

• This device must be used only when the patient is under the continuous and direct supervision of the healthcare professional and frequent observation of the position of the cannula in the patient’s nostrils is necessary.

• Incorrect choice of size, improper placement or use can cause septal trauma or necrosis.

• The cannula tubes can represent a potential strangulation hazard.

•  Always start the gas flow before inserting the cannula into the patient’s nostrils.

•  Do not use if the package is damaged or opened.

•  Do not immerse, wash or sterilize.

• Stop immediately if skin irritation occurs.

• For single patient use only.

• The device must be stored in a suitable, cool and dry place away from heat sources.

• Avoid exposure to direct light sources.

• The product, if it comes into contact with it, has chemical-physical incompatibilities with organic solvents (petrol, benzoyl, esters, ketones, chlorine hydrocarbon).

PART NUMBER	SIZE	PRONGS LENGTH (mm)	OUTER DIAMETER(mm)
13230A73	XXS	7,5	2,3
13230B73	XS	8,5	2,6
13230C73	S	9,5	3,0
13230D73	M	10,5	3,5