Publicité
Classification Medical Device
Class IIb
Europe
Connector, Expiratory hose ex-
Class IIa
tension
UMDNS code Universal Medical
14-238
Device Nomenclature System –
nomenclature for medical devices
Protection class
Type BF
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).
The medical devices meet the requirements of the ISO 80601-2-12 stan-
dard.
1)
Measured in accordance with ISO 80601-2-74
2)
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
Compliance
Radiated emissions
Class A, group 1 (30 MHz to 1 GHz)
Conducted emissions
Class A, group 1 (150 kHz to 30 MHz)
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
Test level and required
electromagnetic environment
Electrostatic discharge (ESD)
Contact discharge: ±8 kV
(IEC 61000-4-2)
Air discharge: ±15 kV
Fast transient electrical
Power cable: ±2 kV
disturbances (bursts)
Longer signal input lines/output
(IEC 61000-4-4)
lines: ±1 kV
Impulse voltages (surges)
Voltage, external conductor –
(IEC 61000-4-5)
external conductor: ±1 kV
Voltage, external conductor –
protective ground conductor: ±2 kV
Magnetic fields at mains
50 Hz: 30 A/m
frequency (IEC 61000-4-8)
Voltage dips and short
Voltage dips of 30 % to 100 %,
interruptions in the supply
8.3 ms to 5 s, different phase angles
voltage (IEC 61000-4-11)
Radiated high-frequency
80 MHz to 2.7 GHz: 3 V/m
disturbances (IEC 61000-4-3)
Conducted high-frequency
150 kHz to 80 MHz: 3 V, ISM bands:
disturbances (IEC 61000-4-6)
6 V
Electromagnetic fields in the
Various frequencies from 385 MHz
vicinity of wireless
to 5785 MHz: 9 V/m to 28 V/m
communication devices
Proximity magnetic fields
134.2 kHz: 65 A/m
(IEC 61000-4-39)
13.56 MHz: 7.5 A/m
EMC phenomena from the environment may cause the humidifier to
react. This could result in error messages, flashing LED's or an
interruption of the heating power which are accompanied by an alarm. In
such cases, ensure that disturbing influences from other devices are
minimized. This can be done, for example, by placing the humidifier in a
different location or by using a different mains outlet.
It is ensured that the humidifier with the connected heatable hoses
complies with IEC 60601-1-2 and thus meets the requirements of Basic
Safety and Essential Performance.
Instructions for use VentStar Helix heated (N) / dual heated (N)
Order list
1)
Designation
VentStar Helix dual heated (N) Plus
VentStar Helix heated (N) Plus
VentStar Neo humidifier chamber
Double connector 11ID/15OD (set of 20)
Soft connector N (set of 20)
Expiratory hose extension
T-piece for nebulization
T-piece for NO-A
Additional items according to Dräger accessories
catalog
1)
Not all articles are available worldwide.
Order No.
MP02650
MP02608
MP02590
MP02655
MP03826
MP02699
MP02689
8422215
English
7
Publicité
