Operation; Technical Data; Ambient Conditions - Dräger VentStar Helix heated Gebrauchsanweisung

English / English US
When used with the Dräger medication nebulizer, use the soft connector
N as shown in the overview:
V
D
S
T
S Soft connector N (MP03826)
T Medication nebulizer (z. B. 8411030)
U Inspiration
V Expiration
Preparation and installation
Install the disposable breathing circuit MP02650 or MP02608 according
to the illustration in the chapter "Overview".
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
Do not nebulize drugs containing alcohol.
CAUTION
Risk of aspiration of condensate
When the breathing circuit with hose extension is used outside of the
incubator, more condensate accumulates.
Dismantle the hose extension when using the breathing circuit outside
of the incubator.
WARNING
Risk of misuse
Installation of the breathing circuit to the basic device must be in
accordance with the instructions for use of the MR850 humidifer
by Fisher & Paykel and of the basic device on which this breath-
ing circuit is used.
WARNING
Risk of patient injury
Fill the humidifier chamber with distilled water before using the
breathing circuit. Check that the maximum water level is not ex-
ceeded so that water cannot enter the breathing circuit.
WARNING
Risk of patient injury
Only use 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 and warming therapy units,
e.g., radiant heaters, the patient-side temperature sensor must be
mounted outside of the heat source or 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 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
Make sure to install the breathing circuit without loops and kinks
as they may increase resistance.
6

Operation

CAUTION
Risk of increased leakage
Confirm that all connections are secure and tight.
CAUTION
U
Risk of patient injury
Perform a selftest of the basic device including a leakage test after the
breathing circuit (hose, filter, etc.) has been completely installed and
before use on the patient.
CAUTION
Risk of burns
Do not operate the heated breathing circuit without gas flow. If the gas
flow is interrupted, switch off the humidifier.
CAUTION
Risk of patient injury
If too much condensate accumulates, a partial or complete blockage of
the breathing circuit can occur.
Regularly check the breathing circuit for condensate and empty if nec-
essary.
CAUTION
Risk of patient injury
If breathing circuits are used with incompatible components, the inspi-
ratory and expiratory resistances can increase to values which exceed
the standard requirements.
If such configurations are used, 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.
CAUTION
Risk of burns
Do not cover the heated breathing circuit with bedclothes, towels, or
similar flammable objects.
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.
NOTE
When operating the breathing circuit in air-conditioned rooms, do not
place it directly next to the outlet port of air-conditioning systems.
Avoid drafts.
Safety information for VentStar heated (N) Plus (MP02608) only
CAUTION
Risk of patient injury
Wrong installation can lead to malfunction of the water trap. Install the
water trap correctly.
WARNING
Risk of patient injury
If the water trap is installed too high in the breathing circuit, con-
densate 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, condensate can accu-
mulate in the breathing circuit. A partial or complete blockage of
the breathing circuit can occur.
Regularly check the water trap for condensate and empty if nec-
essary.
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.
Cleaning
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 1.7 m (66.9 in), including 40 cm
(15.74 in) hose extension
Material
Breathing hoses EVA, PE, TPE
Connections PE, EVA
Y-piece PP
Humidifier chamber PC, SBC, silicone, aluminum
Water trap PP, PE, TPE, POM, SAN, steel
All gas-conducting components are PVC-free.
Performance data
MP02650
Resistance at 2.5/5/15/30 L/min <0.1/0.1/0.6/2.0 mbar
inspiratory (or hPa or cmH
Resistance at 2.5/5/15/30 L/min <0.1/0.2/0.6/2.0 mbar
exspiratory (or hPa or cmH
Compliance at 60 mbar <0.8 mL/hPa
(breathing circuit: inspiration (or mL/mbar)
and expiration)
40 L/min, ≤0.2 kPa
Nominal flow
Leakage at 20/40/60 mbar <15/30/30 mL/min
MP02608
Resistance at 2.5/5/15/30 L/min <0.1/0.1/0.6/2.0 mbar
inspiratory (or hPa or cmH
Resistance at 2.5/5/15/30 L/min <0.1/0.2/1.0/3.3 mbar
exspiratory (or hPa or cmH
Compliance at 60 mbar <1.0 mL/hPa
(breathing circuit: inspiration (or mL/mbar)
and expiration)
Nominal flow 40 L/min, ≤0.2 kPa
Leakage at 20/40/60 mbar <15/30/30 mL/min
MP02590
Compliance at 15/30/60 mbar 0.1/0.35/0.3 mL/hPa
with water (or mL/mbar)
Compliance at 15/30/60 mbar 0.1/0.25/0.25 mL/hPa
without water (or mL/mbar)
Inspiratory volume of the 350 mL
breathing circuit
Maximum operating pressure 80 mbar
Volume (air) of humidifier chamber 190 mL
with water
Volume (air) of humidifier chamber 300 mL
without water
Electrical connection data 22 V, 2.73 A, 60 W,
Ω
14 inspiratory,
Ω
12 expiratory (MP02650)
Warm-up time 30 min
Humidifier output
invasive ventilation >33 mg/L
at 4 to 60 L/min
non-invasive ventilation >10 mg/L
at 4 to 60 L/min

Ambient conditions

During storage
Temperature –20 to 60 °C (–4 to 140 °F)
Relative humidity 5 % to 95 % (non-condensing)
Atmospheric pressure 500 to 1200 hPa
(7.3 to 17.4 psi)
During operation
Temperature 18 to 26 °C (64 to 79 °F)
Relative humidity 10 to 90 % (non-condensing)
Atmospheric pressure 700 to 1060 hPa
(10.2 to 15.4 psi)
Classification according to Directive Class IIa
93/42/EEC Annex IX
UMDNS code Universal Medical De- 14-238
vice Nomenclature System – Nomen-
clature for medical devices
Protection class Type BF
MP02650, MP02608
VentStar Helix dual heated (N) Plus is suitable for standard ventilation
modes, such as Synchronized Intermittend Mandatory Ventilation
(SIMV), Mandatory Minute Ventilation (MMV), and Continuous Positive
Airway Pressure (CPAP) as well as for High Frequency Oscillation
(HFO).
The medical devices meet the requirements of the ISO 80601-2-12 stan-
dard.
1) 1 bar = 1 kPa x 100
Instructions for use VentStar Helix heated (N) / dual heated (N)
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