Technical Data; Order List; Emc Declaration - Dräger VentStar Helix heated Gebrauchsanweisung

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 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 PP, SBC, silicone, aluminum
Water trap PP, PE, TPE, POM, SAN, steel
All gas-conducting components are free of PVC.
Performance data
Maximum operating pressure 80 mbar
Electrical connection data 22 V, 2,73 A, 60 W,

14 inspiratory,

12 expiratory (MP02650)
Warm-up time 30 min
2 L/min
Flow range
Humidifier output
invasive ventilation at >33 mg/L
4 to 60 L/min
non-invasive ventilation at >12 mg/L
4 to 60 L/min
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 <0.1/0.3/1.6/5.0 mbar
inspiratory (or hPa or cmH
Resistance at 2.5/5/15/30 L/min <0.1/0.1/0.4/1.2 mbar
expiratory (or hPa or cmH
Resistance at 2.5/5/15/30 L/min <0.1/0.3/1.2/3.6 mbar
expiratory with expiratory hose (or hPa or cmH
extension
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 <0.1/0.3/1.6/5.0 mbar
inspiratory (or hPa or cmH
Resistance at 2.5/5/15/30 L/min <0.1/0.1/0.6/2.2 mbar
expiratory (or hPa or cmH
Compliance at 60 mbar <1.0 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
MP02590
Compliance at 15/30/60 mbar 0.3/0.3/0.25 mL/hPa
with water (or mL/mbar)
Instructions for use VentStar Helix heated (N) / dual heated (N)
Compliance at 15/30/60 mbar
without water
Inspiratory volume of the breathing
circuit
Volume (air) of humidifier chamber
with water
Volume (air) of humidifier chamber
without water
Ambient conditions
During storage
Temperature
Relative humidity
Ambient pressure
During operation
Temperature
Relative humidity
Ambient pressure
Classification Medical Device
Europe
Connector, Expiratory hose ex-
tension
UMDNS code Universal Medical
Device Nomenclature System –
nomenclature for medical devices
Protection class
MP02650, MP02608
VentStar Helix dual heated (N) Plus is suitable for standard ventilation
modes, such as Synchronized Intermittent 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

EMC declaration

General information
This device was tested for electromagnetic compatibility using accesso-
ries from the list of accessories. Other accessories may only be used if
they do not compromise the electromagnetic compatibility. The use of
non-compliant accessories may result in increased electromagnetic
emissions or decreased electromagnetic immunity of the device.
This device may be used in the direct vicinity of other devices only if
Dräger has approved this device arrangement. If no approval has been
given by Dräger, it must be ensured that this device functions correctly in
the desired arrangement before use. The instructions for use for the other
devices must be followed.
Electromagnetic environment
This device may only be used in environments specified in section "Envi-
ronments of use".
Emissions
Radiated emissions
Conducted emissions
NOTE
The emissions characteristics of this equipment make it suitable for
use in industrial areas and hospitals (CISPR 11 class A). If it is used in
a residential environment (for which CISPR 11 class B is normally re-
quired), this equipment might not offer adequate protection to radio-
frequency communication services. The user might need to take miti-
gation measures, such as relocating or re-orienting the equipment.
Immunity against
1)
O)
2
Electrostatic discharge (ESD)
(IEC 61000-4-2)
O)
2
O)
2
Fast transient electrical distur-
bances (bursts)
(IEC 61000-4-4)
Impulse voltages (surges)
(IEC 61000-4-5)
O)
2
Magnetic fields at mains
O) frequency (IEC 61000-4-8)
2
Voltage dips and short interrup-
tions in the supply voltage
(IEC 61000-4-11)
Radiated high-frequency distur-
bances (IEC 61000-4-3)
Conducted high-frequency dis-
turbances (IEC 61000-4-6)
0.4/0.4/0.31 mL/hPa
Immunity against
(or mL/mbar)
360 mL
Electromagnetic fields in the vi-
cinity of wireless communication
190 mL
devices
300 mL
Recommended separation distances from wireless communication
devices
To ensure that the functional integrity of this device is maintained, there
must be a separation distance of at least 1.0 m (3.3 ft) between this de-
vice and wireless communication devices.

Order list

–20 to 60 °C (–4 to 140 °F)
Designation
5 to 95 % (non-condensing)
500 to 1200 hPa (7.3 to 17.4 psi) VentStar Helix dual heated (N) Plus
VentStar Helix heated (N) Plus
18 to 26 °C (64 to 79 °F)
VentStar Neo humidifier chamber
10 to 90 % (non-condensing)
Double connector 11ID/15OD (set of 20)
700 to 1060 hPa
Soft connector N (set of 20)
(10.2 to 15.4 psi)
Expiratory hose extension
Class IIb
T-piece for nebulization
Class IIa
T-piece for NO-A
14-238
Additional items according to Dräger accessories
catalog
Type BF
1) Not all articles are available worldwide.
Compliance
Class A, group 1 (30 MHz to
1 GHz)
Class A, group 1 (150 kHz to
30 MHz)
Test level and required electro-
magnetic environment
Contact discharge: ±8 kV
Air discharge: ±15 kV
Power cable: ±2 kV
Longer signal input lines/output
lines: ±1 kV
Voltage, external conductor –
external conductor: ±1 kV
Voltage, external conductor –
protective ground conductor:
±2 kV
50 Hz: 30 A/m
Voltage dips of 30 % to 100 %,
8.3 ms to 5 s, different phase
angles
80 MHz to 2.7 GHz: 3 V/m
150 kHz to 80 MHz: 3 V,
ISM bands: 6 V
English / English US
Test level and required electro-
magnetic environment
Various frequencies from 385 MHz
to 5785 MHz: 9 V/m to 28 V/m
1)
Order No.
MP02650
MP02608
MP02590
MP02655
MP03826
MP02699
MP02689
8422215
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