Diamedica Baby CPAP 10 User manual

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 1of 26
Baby CPAP 10 & 20
Instructions for use
Diamedica (UK) Ltd
Grange Hill Industrial Estate
Bratton Fleming, Barnstaple, Devon,
EX31 4UH, United Kingdom
Tel: [phone]
WhatsApp: [phone]
Email: [e-mail]
Web: www.diamedica.co.uk
Alphamed Consulting Ltd, Knock, Barnaderg,
Tuam, Co. Galway, H54 W220
Revision D 02/02/2023 DCN-0211
ENG
1639
0120

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 2of 26
Read this page first
INTENDED USE
This device is suitable for use in hospital settings with limited resources or in any field or
outreach locations (where a suitable power source is available) and is suitable for neonates
and paediatric patients. CPAP 10 for neonates (< 5kg only) and CPAP 20 for neonates and
paediatric patients (<20kg)
Note: These weights and parameters should be considered by the clinical team as a guideline
only. Clinical decisions should be decided by the clinical team on a case by case basis
depending on the patient’s condition.
The Diamedica Baby CPAP provides effective and efficient non-invasive airway pressure
support to neonate and paediatric patients in difficult environments.
FOREWORD
This manual is intended to provide guidance on the function, performance and user
maintenance of the Diamedica Baby CPAP. The information given in this manual is correct at
the date of publication.
A separate user manual for the oxygen concentrator is also included and must be reviewed for
specific safety and maintenance requirements before use.
The policy of Diamedica (UK) Ltd is to continuously improve its products. Changes may be
made to this manual without notice being given.
Users of the Diamedica Baby CPAP must read, understand and follow the guidance given in
this manual before using the system.
THE NEED FOR PATIENT MONITORING
The Diamedica Baby CPAP delivers adjustable mixtures of oxygen-enriched air to the patient
and the device should be monitored at all times.
It is essential that the patient’s oxygen saturation and other vital functions are also monitored.
The ultimate responsibility for patient safety remains with the operator.
Observations of the patient must take precedence over machine settings in judging the
condition of the patient.
The system is only intended for use by competent medical personnel.

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 3of 26
CONTRAINDICATIONS, CAUTIONS & WARNINGS
CPAP should not be initiated in patients for whom improvement on nasal CPAP is unlikely, or
whose condition requires alternative intervention. These conditions could be, but are not
restricted to the following.
Known pneumothorax
Upper airway obstruction including croup, epiglottitis, suspected tracheitis.
Following traumatic injury
Facial and nasal abnormalities
The use of nasal cannula is contraindicated for patients with nasal atresia or patients with
facial structure deformities that prohibit adequate respiratory support.
Improper selection of size, improper positioning or improper use of nasal cannula may result in
inconsistent CPAP pressures, septal trauma or necrosis.
Always begin gas flow prior to inserting prongs into patient’s nares.
Frequent observation of prongs position in patient’s nares may be necessary.
Cannula tubing can pose a potential strangulation hazard.
Discontinue immediately if skin irritation occurs.
Do not leave unit running while not in use.
Do not use in the presence of a naked flame.
Do not smoke in vicinity of unit whilst in use.
Please refer to all warnings listed in accompanying Oxygen Concentrator manual before use.
Only persons who have read and understood this entire manual and
therefore deemed competent, are authorized to operate this equipment

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 4of 26
DIAMEDICA BABY CPAP 10 / 20 MANUAL
1. INTRODUCTION
2. CLEANING, GENERAL MAINTENANCE AND DISPOSAL
3. THE COMPONENT PARTS OF THE BABY CPAP
4. SETTING UP THE BABY CPAP
5. ALARMS AND INDICATORS
6. POWER CIRCUIT PROTECTION
7. SPECIFICATIONS
8. GLOSSARY

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 5of 26
1. INTRODUCTION
CPAP is the application of continuous positive airway pressure throughout the respiratory
cycle. The use of CPAP can assist children with severe respiratory distress.
Worldwide new-born deaths account for more than 40% of the mortality in children under the
age of five years. Respiratory dysfunction is a common cause of death in new-borns and is
often associated with prematurity/low birth weight, infections as well as peri-
partum complications.
The most common causes of respiratory dysfunction in neonates are:
-Respiratory infections
-Surfactant deficiency (respiratory distress syndrome/RDS)
-Meconium aspiration
-Respiratory problems associated with critical illness/severe sepsis.
-Congenital heart diseases and congenital pulmonary/thoracic abnormalities are less
common.
-Severe respiratory problems can be associated with persistent pulmonary hypertension
of the new-born.
The introduction of bubble CPAP on a neonatal unit should be an important element of an
improved “neonatal care package” adapted to resource limited contexts.
The Diamedica Baby CPAPs are self-contained mobile units that are powered by mains
electricity. Based on an oxygen concentrator, these units supply their own oxygen and
medically filtered air to deliver and maintain a positive airway support at an adjustable set
oxygen concentration level.
The unit has a bubble container to adjust the delivery pressure and adjustable flow rates for
achieving the required oxygen concentration. This unit also warms and humidifies the
delivered gas mix. The gas mix is delivered to the patient via a nasal cannula.
Supplied as two variants (CPAP 10 and CPAP 20) both deliver adjustable pressure up to 10cm
H₂O
The CPAP 10 version is suitable for neonates, with the CPAP 20 version having a higher flow
capacity being suited to the support of both neonates and larger infants.

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 6of 26
Both units are supplied with integrated voltage protection to protect them from irregular
power fluctuations that could otherwise cause damage.
Both units can be supplied with an optional UPS (Uninterruptible Power Supply) unit which
provides not only voltage stabilisation but also battery backup for power outages. For more
information, please contact Diamedica.

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 7of 26
2. CLEANING, GENERAL MAINTENANCE AND DISPOSAL
The following guidelines should be reviewed in line with the facility’s own cleaning
procedures and PPE requirements.
What You Need:
1. Soap for initial clean.
2. Disinfectant solution: (sodium hypochlorite 0.05% or household bleach, diluted to 0.05%
hypochlorite. The household bleach bottle will indicate its strength, dilution is essential)
Note 5 ml (1 teaspoon) household bleach (5.25% sodium hypochlorite) + 500 ml water=
0.05%.
3. Brush to clean both inside and outside of circuit. All brushes and cleaning implements must
be properly cleaned after use.
4. Drying rack.
Cleaning of the Circuit Tubing and Bottles:
This should be done after each patient has used the CPAP, and weekly if the same child is on
CPAP for over a week.
The CPAP circuit which comprises of an inspiratory and expiratory limb, bubble bottle, lid and
connections, humidification bottle and water trap must all be thoroughly cleaned as follows:
1. Remove any gross contamination by first washing all components thoroughly in a detergent
solution (soap and water). Use a clean container and brush the equipment thoroughly
under water to prevent splash and ensure all visible soiling is removed.
2. Rinse with water that has been boiled and allowed to cool to tepid. Let it dry.
3. Wash next in diluted bleach or disinfectant and leave soaking for one hour. Soak all items
together, do not keep use solution for subsequent components. Once used, bleach should
not be re-used or kept in storage, discard after use.
4. Rinse with water that has been boiled and cooled to tepid (rinse also inside, for example,
using a sterile syringe), let it drip dry over the sink, do not leave it coiled on the sink.
5. Check that there is no pooled water in the circuit. Store the circuit and bottle in a clean
plastic bag (labelled and dated). Store in the dry and clean area (separate from a soiled
equipment area).

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 8of 26
Infection prevention and CPAP circuit
a. CPAP circuit & tubing
-Change after 1 week.
-Change earlier if any significant soiling.
-Ensure that there is no accumulation of condensed water in any part of the circuit.
-External cleaning of the tubes in case of soiling (with water & soap).
Humidification
Change water for humidification every shift (every 12 hours).
Change humidification bottle weekly.
Always keep a stock of single patient use- humidification bottles on your bubble CPAP trolley.
Autoclavable bottles can be used. Before use, ensure that they are working correctly (e.g. no
leaks)
-Use sterile water or normal saline.
-During the change of water/humidification bottle –ensure patient- safety. The circuit
should be interrupted only for a short period of time.

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 9of 26
Water trap
-Change every 1 week.
-Empty at least every shift or when significant amount of water accumulated.
-Wash and clean water trap container (with soap and water)
-During change of water, ensure that circuit is not interrupted. The water- trap is
designed in a way, that during the emptying of the bottle, the circuit will not be
interrupted.
-Make sure that there is no accumulation of water or condensation in the circuit (see
above).
Cleaning the CPAP unit
This should be carried out once per week as a minimum.
The CPAP units have a large particulate filter over the air inlet opening. This filter stops dust
and other airborne particles from entering the unit and is easily removed from the inset panel
on the back of the machine shown below.
The filter should be removed and cleaned in warm soapy water, completely dried with an
absorbent towel and replaced. Have a spare dry filter to replace with so there are minimal
interruptions to the concentrator function.
Water- trap –bottle can be
detached from the “green
section”, without interrupting
the CPAP circuit.

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 10 of 26
Warning. Do not attempt to operate the unit without the air filter or while the filter is still
damp.
The exterior of the Bubble CPAP should be cleaned with a mild disinfecting cleaning agent or a
diluted solution of bleach (usually 5.25% sodium hypochlorite) in line with the facility’s own
equipment cleanliness procedures.
Please also refer to the accompanying concentrator manual and the CPAP maintenance manual
to understand and plan preventative maintenance requirements.
Accessories and spares
All accessories used with the Baby CPAP must:
•Be oxygen compatible,
•Be biocompatible,
•Comply with the general requirements of the 93/42/EEC European Directive
A full list of available spares is available by contacting Diamedica –[email protected]

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 11 of 26
3. THE COMPONENT PARTS OF THE BABY CPAP
Image shown is 10l version 20l may differ in appearance
Image shown above is 10l version, 20l may differ in appearance.
Air flow meter
Oxygen flow meter
Bubble bottle with
dial-up CPAP pressure
level
Circuit breaker
Expiratory limb
Warning lights
Water trap
Inspiratory limb
Humidification bottle
External foam filter
Power connection
Bubble bottle
holder
Voltage protector
Oxygen and air
mixing chart

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 12 of 26
4. SETTING UP THE BABY CPAP
Follow the steps below to use the Baby CPAP:
1Position the unit so that it is at least 30 cm away from walls or curtains, so that the inlet
opening at the back is not obstructed.
2Plug the power cord into the mains electricity supply and turn on the supply.
3Switch on the unit.
4On start up all lights on the unit should illuminate with the alarm sounding for one second.
5Following start up if the oxygen purity is below the acceptable level, the yellow low oxygen
light will remain illuminated until 87% O2delivery concentration has been reached.
6After a few seconds but up to a few minutes the low oxygen light (yellow) will then go out
and the correct oxygen level light (green) will come on.

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 13 of 26
7. Fill the bubble bottle to the level indicated with boiled (or sterile) water that has been
allowed to cool and screw the lid back on. Once filled to the correct level attach bubble
bottle to the bracket on the side of the CPAP unit.
8.Fill the humidifier bottle with sterile water or N-Saline (do not over fill). Connect the
humidifier bottle to the gas port outlet and ensure the grill below is not obstructed.

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 14 of 26
9. Connect the inspiratory limb of the circuit to the main gas outlet. A water trap can be
attached to the inspiratory circuit if required.
10. Connect the expiratory limb of the circuit to the bottle, ensuring that connections are
firmly engaged.
11. Dial up the level of CPAP required: start at 7 cm H2O (see figure below).
Bottle with dial-up
CPAP level
Expiratory limb
Water trap

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 15 of 26
12. Dial the flows of air and oxygen required (check the mixing chart to ensure that these
settings give the required O2concentration) to see a constant stream of bubbles in the
water. Occlude nasal prongs to ensure bubbles in the bubble bottle. Starting values as
follows:
Children > 5kg: start with 5 L/min of oxygen and 5 L/min of air.
Infants and neonates 2.5 –5kg: use an initial total flow of 6-10lpm.
Neonates <2.5kg: use an initial total flow of 4-6lpm.
Start pressure of 7 cm H2O
Check and record the flows dialled and the oxygen concentration this provides. The equal
starting flow rates will deliver 58% O2 concentration as can be seen on the mixing charts
shown below. In most cases these values will be enough to deliver CPAP, which you can see
by continuous bubbling in the bottle.
Baby CPAP 10 oxygen /air mixing chart
Baby CPAP 20 oxygen /air mixing chart

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 16 of 26
13. Connect the nasal prongs to the child as below:
-Make sure no pressure is put on facial skin. Special care needs to be taken to not exert
too much pressure on the nasal septum.
-The prongs should not completely obstruct the nares. A leak on this level is acceptable
and can be compensated by increasing the air/oxygen flow.
-Non- nutritive sucking with sucrose or some expressed maternal milk can help to
improve the comfort of the child.
Close the top of
bonnet by twisting
bonnet until tightly
secure to head crown.
Secure with ribbon
provided.
Place the bonnet on
patient’s head, centring
the securement line
indicator.
With the bonnet
centred at nape of neck,
place remaining bonnet
on infant.
Cut self-adhesive Velcro
in half and secure to the
bonnet.
Attach chin strap to
the infant and secure
to Velcro.
Place the nasal prong
into the infant’s
nostril.
Ensure gas flow is on
prior to inserting the
prongs into patient’s
nostril.
Secure tubing by
placing elastic strap
over tubing and secure
to Velcro. Elastic strap
is correctly positioned
when strap is in line
within the securement
line indicator.

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 17 of 26
Positioning of prongs
-Prongs should be inserted into patient’s nostrils with a small gap between patient’s
septum and base of prongs.
-Correct fitting prongs will fill approximately 80% of the nostril. Ensure that prongs do
not fill nostrils completely.
-Ensure, that no part of the nostril/skin is exposed to pressure.
-A leak can be compensated by increasing the flow.
Skin care
-All tapes used (e.g. for naso or oro-gastric tubes, IV lines) need to be “skin- friendly”.
Prongs
-Change every 3 days or earlier if any significant soiling or obstruction.
Different sizes and types are available:
Options:
1) Hudson prongs (different sizes)
Take special care of the nasal septum. Always
leave a gap between the nasal septum and the
prongs.

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 18 of 26
Nasal Prong kits
Ram cannula option
Product code
Description
Bonnet Size
CPAP/SP2/S
CPAP Nasal Kit (prong # 0 - 1)
Size 1, S (22-25cm)
CPAP/SP2/M
CPAP Nasal Kit (prong # 2 - 3)
Size 2, M (25-28cm)
CPAP/SP2/L
CPAP Nasal Kit (prong # 4 - 5)
Size 3, L (28-31cm)
CPAP/SP2/XL
CPAP Nasal Kit (prong # 6 - 7)
Size 4, XL (31-34.5cm)
Product code
Item size
Nasal prongs
septal space
Nasal prongs
outer diameter
N4900
Micro Preemie
2.5 mm
3 mm
N4901
Preemie
4.2 mm
3 mm
N4902
New-born
4.8 mm
3.5 mm
N4903
Infant
5 mm
4 mm
N4904
Small
5.75 mm
5.25 mm
N4905
Medium
6.75 mm
5.75 mm
N4906
Large
7.75 mm
6.5 mm

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 19 of 26
CO2gas sampling port
Patient monitoring
14. Check the child for signs of respiratory distress, check the SpO2, and check if there are
bubbles in the bottle.
15. If the SpO2is below 90% or the child has severe respiratory distress, set CPAP pressure
level to 7 cm H₂O and then, if no response, increase the oxygen flow meter and reduce
the air flow meter by equal amounts as required.
16. If there are not continuous bubbles, check the nasal prongs are attached properly, and
reposition them so they fit snugly inside the nostrils. Refer to fitting note on previous
page.
17. If there are still not continuous bubbles, check for leaks along the circuit, and adjust the
oxygen or air flows according to the chart below.
Check for bubbles in the pressure regulation bottle.
-Bubbles should be present during the whole respiratory cycle.
-Exclude any obstruction in the circuit and the patient’s airway.
There is a CO2gas sampling port fitted to the nasal
prong inspiratory connector (Blue).

CPAPDVB - MANUAL ENG © Copyright Diamedica (UK) Ltd 2023 Page 20 of 26
SpO2> 90% and mild
or no respiratory
distress
SpO2> 90% but
moderate to severe
respiratory distress
SpO2< 90%
Bubbles
No immediate change
needed, may be able
to reduce CPAP level
gradually
Increase CPAP level
Increase CPAP level.
Increase oxygen flow
No bubbles
Check nasal interface
and complete
air/oxygen circuit
(including humidifier
and water- trap).
Consider weaning
CPAP pressures &
FIO2.
Check nasal interface
and complete air/
oxygen circuits.
Increase air flow,
check for bubbles.
Increase CPAP level
Check nasal interface and
complete air/oxygen circuit.
Increase oxygen flow, check
for bubbles.
Increase CPAP level