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Preparation and installation
Install the disposable breathing circuit MP02650 or MP02608 according
to the illustration in the chapter "Overview".
–
Pre-assembled products are color-coded
–
Inspiration is colored blue (A, B, C, L)
–
Expiration is colored white/transparent (E, Q)
–
Take the water chamber (G) and unwind the water feeding line
–
Slide the water chamber (G) on the heater plate
–
Connect the feeding line (K) to a sterile water source
–
Connect the short blue hose (B) to the inspiratory port (A) of the
ventilator and connect the other end of the hose to the water chamber
–
Connect the blue inspiratory hose (C) to the second opening of the
water chamber
–
Connect the sleeve of the white/transparent expiratory hose (Q, E) to
the exspiratory port of the ventilator
WARNING
Risk of patient injury
When installing the breathing circuit, make sure not to mix up the
inspiratory hose and the expiratory hose. Note the illustration in
the chapter "Overview": The temperature sensors are in the in-
spiratory limb.
WARNING
Risk of patient injury
During installation position the breathing circuit so that the risk
of tripping or of stepping on the breathing circuit is minimized.
WARNING
Risk of patient injury
Nebulize only water-based drugs.
WARNING
Risk of patient injury
Only use sterile distilled water. The use of other substances can
harm the patient.
WARNING
Risk of patient injury
If the humidifier chamber is positioned too high in the breathing
circuit, water may enter the breathing hoses.
The humidifier chamber must be positioned lower than the pa-
tient.
WARNING
Risk of increased gas temperature
Temperature regulation by the device is not possible if the tem-
perature sensor is not correctly attached.
Insert both temperature sensors all the way to the stop so that the
temperature sensors are firmly attached to the breathing circuit.
CAUTION
Risk of reduced humidification
When used in conjunction with incubators, the patient-side temperature
sensor must be mounted outside of the incubator.
WARNING
Risk of patient injury
Filters must not be connected to the patient-side (e.g., the Y-
piece) of the breathing circuit.
Connect filters only to the inspiratory valve or the expiratory
valve of the ventilator and monitor pressure buildup.
WARNING
Risk of fire
Do not clamp together the breathing hoses of a dual heated
breathing circuit.
WARNING
Risk of patient injury
Exposing a premature baby to elevated concentrations of oxygen
may lead to Retrolental Fibroplasia (retinopathy of prematurity).
Operation
CAUTION
Risk of patient injury
Too high or too low ambient temperatures can lead to increased accu-
mulation of humidity or humidification performance can be reduced.
Do not operate the device outside the stated ambient temperature
range.
CAUTION
Risk of increased leakage
Confirm that all connections are secure and tight.
WARNING
Risk of patient injury
Perform a self-test of the main device including a leakage test af-
ter the breathing circuit (hose, filter, etc.) has been completely in-
stalled and before use on the patient.
WARNING
Risk of patient injury
A Luer Lock connector must only be used for gas monitoring.
Any other use of the Luer Lock connector may endanger the pa-
tient.
6
CAUTION
Risk of patient injury
If too much condensed water accumulates, a partial or complete block-
age of the breathing circuit can occur.
Regularly check the breathing circuit for condensed water and empty if
necessary.
CAUTION
Risk of patient injury
If breathing circuits are used with additional or incompatible compo-
nents, such as filters or hose extensions, the inspiratory and expiratory
resistances can increase to values which exceed the standard require-
ments. The ventilation performance may be adversely affected.
If such configurations are used, ensure suitable patient monitoring and
pay special attention to the measured values.
CAUTION
Risk of skin irritation
Avoid prolonged and direct contact between the heated breathing cir-
cuit and the patient's skin.
WARNING
Risk of burns
Do not cover the heated breathing circuit with bedclothes, tow-
els, or similar flammable objects.
NOTE
When operated in rooms with air conditioning, the breathing circuit
must not be positioned directly next to the outlet ports of air conditioning
units.
Avoid drafts.
Safety information for VentStar Helix dual heated (N) Plus
(MP02650) only
WARNING
Risk of burns
If the temperature in the incubator is above 37.5 °C (99.5 °F) and
a dual heated breathing circuit (MP02650) is used, an unheated
hose extension (white, MP02699) must be used in the expiratory
limb of the breathing circuit. Without the hose extension the sur-
face of the breathing circuit may get too hot.
If the temperature in the incubator is above 37.5 °C (99.5 °F), use the ex-
piratory hose extension (white, MP02699) as shown in the illustration:
W
D
L
W Expiratory hose extension (white, MP02699) for use with dual heated
breathing circuit (MP02650) if the temperature in the incubator is
above 37.5 °C (99.5 °F)
Insert the expiratory hose extension (W, white) between the Y-piece (D)
and the heated expiratory hose (E, white) in the expiration (V). The inspi-
ratory hose extension (L, blue) and heated inspiratory hose (C, blue) re-
main unmodified.
Safety information for VentStar Helix heated (N) Plus (MP02608)
only
WARNING
Risk of patient injury
If the water trap is installed too high in the breathing circuit, con-
densed water can flow into the breathing hoses.
Install the water trap at the lowest point of the breathing circuit
and below patient level.
WARNING
Risk of patient injury
If the water trap is not emptied regularly, condensed water can
accumulate in the breathing circuit. A partial or complete block-
age of the breathing circuit can occur.
Regularly check the water trap for condensed water and empty if
necessary.
WARNING
Risk of contamination
The contents of the water trap can be contaminated.
Dispose of the contents of the water trap in accordance with the
hospital's regulations. Proceed with caution when handling the
water trap.
CAUTION
Risk of patient injury
When the water trap container is disconnected from the water trap,
there is a higher risk of leakage. During a leakage PEEP may fall and
VT may not be reached.
After emptying reinstall and close the water trap container as quickly as
possible.
WARNING
Risk of malfunction
If the water trap does not hang vertically, malfunction can occur.
Install the water trap vertically.
Period of use
The user is responsible for regularly replacing the medical device accord-
ing to the hospital's hygiene regulations.
WARNING
Reuse, reprocessing, or sterilization can lead to failure of the
medical device and cause injury to the patient.
This medical device has been designed, tested, and manufac-
tured exclusively for single use. The medical device must not be
reused, reprocessed, or sterilized.
NOTE
This medical device has been designed, tested, and manufactured ex-
clusively for single-patient use and for a period of use not exceeding
14 days.
Disposal
After use, the medical device must be disposed of according to the appli-
cable hospital, hygiene and waste disposal regulations.
Technical data
Length of breathing hoses (insp.)
MP02650, MP02608
Inspiratory volume of the breathing
circuit (with filled humidifier chamber)
Material
Breathing hoses
Connectors
Y-piece
Water trap
Humidifier chamber MP02590
Humidifier chamber MP02509
All gas-conducting components are free of PVC.
Performance data
Maximum operating pressure
Electrical connection data
E
V
1)
Sound pressure level
Flow range
U
C
Essential performance of the medical device in combination with catego-
ry 1 humidifiers according to ISO 80601-2-74, Clause 201.12.1.101a:
For humidifiers equipped with set temperature monitoring equipment,
delivery of humidification output or generation of a technical or physio-
logical alarm condition.
MP02650
Resistance at 2.5/5/15/30 L/min
inspiratory
Resistance at 2.5/5/15/30 L/min
expiratory
Resistance at 2.5/5/15/30 L/min
expiratory with expiratory hose
extension
Compliance at 60 mbar
(breathing circuit: inspiration
and expiration)
Leakage at 20/40/60 mbar
MP02608
Resistance at 2.5/5/15/30 L/min
inspiratory
Resistance at 2.5/5/15/30 L/min
expiratory
Compliance at 60 mbar
(breathing circuit: inspiration
and expiration)
Leakage at 20/40/60 mbar
Humidifier chamber MP02590 / MP02509
Compliance at 60 mbar
with water/without water
Max. water volume of humidifier
chamber
Warm-up time
Humidifier output
invasive ventilation
at 2 to 60 L/min
non-invasive ventilation
at 2 to 60 L/min
Ambient conditions
During storage
Temperature
Relative humidity
Ambient pressure
During operation
Temperature
Relative humidity
Ambient pressure
Instructions for use VentStar Helix heated (N) / dual heated (N)
1.7 m ±10 % (66.9 in ±10 %),
including 40 cm ±10 % (15.74 in
±10 %) hose extension
360 mL ±10 %
EVA, PE, TPE
PE, EVA
PP
PP, PE, TPE, POM, SAN, steel
PP, SBC, PVC, ABS, silicone,
aluminum
PC, SBC, PVC, ABS, silicone,
aluminum
80 mbar
22 V, 2,73 A, 60 W,
14 Ω inspiratory,
12 Ω expiratory (MP02650)
<50 dB (A)
≥2 L/min
2)
<0.1/0.2/1.0/3.0 mbar
(or hPa or cmH
O)
2
<0.1/0.2/0.7/2.4 mbar
(or hPa or cmH
O)
2
<0.1/0.2/0.8/2.7 mbar
(or hPa or cmH
O)
2
<0.8 mL/hPa
(or mL/mbar)
<15/30/30 mL/min
<0.1/0.2/1.0/3.0 mbar
(or hPa or cmH
O)
2
<0.1/0.2/1.0/3.3 mbar
(or hPa or cmH
O)
2
<1.0 mL/hPa
(or mL/mbar)
<15/30/30 mL/min
<0.3/<0.4 mL/hPa
(or mL/mbar)
170 mL
30 min
>33 mg/L
>12 mg/L
–20 to 60 °C (–4 to 140 °F)
5 to 95 % (non-condensing)
500 to 1200 hPa (7.3 to 17.4 psi)
18 to 26 °C (64 to 79 °F)
10 to 90 % (non-condensing)
700 to 1060 hPa (10.2 to 15.4 psi)
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