Dräger VentStar Helix heated Notice D'utilisation page 5

WARNING
Risk of increased gas temperature
Temperature regulation by the device is not possible if the tem-
perature sensor is not correctly fitted.
Fit the temperature sensors (G) and (H) securely to the breathing
circuit.
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.
Operation
CAUTION
Risk of increased leakage
Confirm that all connections are secure and tight.
WARNING
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
During installation position the breathing circuit so that the risk
of tripping or of stepping on the breathing circuit is minimized.
WARNING
Risk of too much condensed water in the breathing circuit
If too much condensed water accumulates, a partial or complete
blockage 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 and incompatible compo-
nents, the inspiratory and expiratory resistances can increase to values
which exceed the standard requirements.
If such configurations are used, pay special attention to the measured
values.
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 increased leakage
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 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 malfunction
If the water trap does not hang vertically, malfunction can occur.
Install the water trap vertically.
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.
Instructions for use VentStar Helix heated / VentStar Helix dual heated
WARNING
Risk of patient injury
When using active humidification, do not use the breathing cir-
cuit in conjunction with a heat and moisture exchanger (HME).
There is a risk of pressure buildup and of insufficient ventilation
as a result of water accumulating in the HME.
WARNING
Do not modify the medical device. Modification may damage or
impair the proper functioning of the device which may lead to pa-
tient injury.
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.
Period of use
The user is responsible for regularly replacing the medical device accord-
ing to the 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
Breathing hose length 1.6 m (62.99 in)
Material
Breathing hoses EVA, PE, TPE
Connections PE, EVA
Y-piece PP
Humidifier chamber PP, SBC, silicone, aluminum
Water trap PP, TPE, POM, SAN, steel
All gas-conducting components are free of PVC.
Performance data
Volume of the inspiratory limb approx. 1000 mL
Resistance at 15/30/60 L/min <0.2/0.6/2.0 mbar
inspiratory
MP02606:
Resistance at 15/30/60 L/min <0.2/0.4/1.3 mbar (cmH2O)
expiratory
MP02607:
Resistance at 15/30/60 L/min 0.5/1.8 mbar (cmH2O)
expiratory
Compliance at 60 mbar <3 mL/hPa (3 mL/mbar)
(breathing circuit)
MP02605:
Compliance at 60 mbar 0.4/0.5 mL/hPa
with water/without water (0.4/0.5 mL/mbar)
Operating pressure max. 60 mbar
Leakage at 60 mbar <50 mL/min
Electrical connection data 22 V, 2.73 A, 60 W,

14 inspiratory,

12 expiratory
Volume (air) of humidifier chamber
with water/without water 260/450 mL
Warm-up time 30 min
Humidifier output
Invasive ventilation at >33 mg/L
6 to 60 L/min
Non-invasive ventilation at >10 mg/L
6 to 120 L/min
Essential performance of the medical device in combination with cate-
gory 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.
Ambient conditions
During storage
Temperature –20 to 60 °C (–4 to 140 °F)
Relative humidity 5 to 95 % (non-condensing)
Ambient 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)
Ambient pressure 700 to 1060 hPa
(10.2 to 15.4 psi)
Classification Medical Device Class IIb
Europe
UMDNS code
Universal Medical Device
Nomenclature System –
Nomenclature for medical devices
Protection class
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
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Fast transient electrical distur-
bances (bursts)
(IEC 61000-4-4)
Impulse voltages (surges)
(IEC 61000-4-5)
1)
(cmH2O)
Magnetic fields at mains fre-
quency (IEC 61000-4-8)
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)
Electromagnetic fields in the vi-
cinity of wireless communication
devices
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
Designation
VentStar Helix heated
VentStar Helix dual heated
AutoFeed Chamber (humidifier chamber)
Additional items according to Dräger accessories
catalog
English / English US
14-238
Type BF
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 – ex-
ternal conductor: ±1 kV
Voltage, external conductor – pro-
tective ground conductor: ±2 kV
50 Hz: 30 A/m
Voltage dips of 30 % to 100 %,
8.3 ms to 5 s, different phase an-
gles
80 MHz to 2.7 GHz: 3 V/m
150 kHz to 80 MHz: 3 V, ISM
bands: 6 V
Various frequencies from 385 MHz
to 5785 MHz: 9 V/m to 28 V/m
Part number
MP02607
MP02606
MP02605
5