Dräger VentStar Aquapor heated A/P Instrucciones De Uso página 5

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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.
Operation
CAUTION
Risk of increased leakage
Confirm that all connections are secure and tight.
CAUTION
Perform a selftest of the basic device including a leakage test after the
breathing circuit (hose, filter/HME, 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.
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.
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 too much condensate in the breathing circuit
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 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, 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 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-
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 malfunction
If the water trap does not hang vertically, malfunction can occur.
Install the water trap vertically.
Instructions for use VentStar Aquapor heated A/P / VentStar Aquapor dual heated A/P
CAUTION
Risk of skin irritation
Avoid longer and direct contact between the heated breathing circuit
and the patient's skin.
CAUTION
Risk of burns
Do not cover the heated breathing circuit with bedclothes, towels, or
similar objects.
WARNING
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.
CAUTION
Risk of increased leakage
Wrong installation can lead to malfunction of the water trap.
Install the water trap correctly.
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.
Cleaning
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 7
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
PC, SBC, silicone, aluminum
Water trap
PP, TPE, POM, SAN, steel
All gas-conducting components are PVC-free.
Performance data
Operating pressure
max. 80 mbar
Leakage at 60 mbar
<50 mL/min
Electrical connection data
22 V,
14
inspiratory 30 W,
14
expiratory 30 W
Volume (air) of humidifier chamber
with water/without water
260/450 mL
Warm-up time
30 min
Humidifier output
Invasive ventilation
>33 mg/L
at 6 to 60 L/min
Non-invasive ventilation
>12 mg/L
at 6 to 80 L/min
Resistance at 15/30/60 L/min
<0.2/0.5/2.0 mbar
inspiratory
(<0.2/0.5/2.0 cmH2O)
Inspiratory limb volume
approx. 1000 mL
Flow range
6 to 80 L/min
MP07130
Resistance at 15/30/60 L/min
<0.2/0.4/1.3 mbar
exspiratory
(<0.2/0.4/1.3 cmH2O)
MP07131
Resistance at 15/30/60 L/min
<0.2/0.5/1.8 mbar
exspiratory
(<0.2/0.5/1.8 cmH2O)
Compliance at 60 mbar
<3 mL/hPa (3 mL/mbar)
(breathing circuit)
MP02605
Compliance at 60 mbar
0.3/0.45 mL/hPa
with water/without water
(0.3/0.45 mL/mbar)
Essential Performance of the medical device in combination with
category 1 humidifier 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
Relative humidity
Ambient pressure
During operation
Temperature
Relative humidity
Ambient pressure
Classification Medical
Device Europe
UMDNS code Universal Medical De-
vice Nomenclature System – Nomen-
clature for medical devices
Protection class
The medical devices meet the requirements
of the ISO 80601-2-12 standard.
1)
1 bar = 1 kPa x 100
Order list
Designation
VentStar Aquapor dual heated A/P
VentStar Aquapor heated A/P
Disposable humidifier chamber
Additional items according to Dräger accessories
catalog
1)
English / English US
–20 to 60 °C (–4 to 140 °F)
5 % to 95 % (non-condensing)
500 to 1200 hPa
(7.3 to 17.4 psi)
20 to 26 °C (68 to 79 °F)
10 to 90 % (non-condensing)
700 to 1060 hPa
(10.2 to 15.4 psi)
Class IIa
14-238
Type BF
Part number
MP07130
MP07131
MP02605
5
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