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Intended Purpose; Indications For Use; Intended Use Environment; Contraindications - SECHRIST 3600 Gebruikershandleiding

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INTENDED PURPOSE

The Sechrist Air/Oxygen Gas Mixers are designed to mix medical grade air and medical grade oxygen, at operator selected ratios, for delivery
to patients receiving respiratory care through various respiratory care and heart-lung bypass equipment.
The Sechrist Air/Oxygen gas mixer is a precision pressure regulation and proportioning device, which is designed to accurately mix medical
grade air and medical grade oxygen. The gas mixer can provide FiO
and heart-lung bypass equipment.

INDICATIONS FOR USE

The Sechrist Air/Oxygen gas mixers may be indicated whenever precise concentrations of oxygen are required for clinical applications. Use of
the gas mixer in its appropriate configuration may be found throughout the healthcare environment. The Sechrist air/oxygen mixer is a
precision pressure regulation and proportioning device, which is designed to accurately mix medical grade air and medical grade oxygen (O
The mixer can provide FiO
's of .21 to 1.0 for delivery to a variety of respiratory devices.
2
Intended Patient Population: Do not use high flow gas mixers for neonate and pediatric patients.
Medical Condition to be Treated: Patients who need supplemental oxygen therapy ranging from .21 to 1.0 FiO
various types of respiratory care and heart-lung bypass equipment.
Principle of Operation/Mode of Action: The Sechrist Air/Oxygen Mixer is a precision pressure regulation and proportioning device which is
designed to accurately mix medical grade air and medical grade oxygen to any selected O
100%, for delivery to a variety of respiratory care and heart-lung bypass equipment.
Key Performance and Safety Claims: Sechrist Air/Oxygen Mixer is designed to mix medical grade air and medical grade oxygen.

INTENDED USE ENVIRONMENT

Device is designed for hospital and clinic use only for delivery of precise oxygen concentrations directly to the patient or delivery of precise
FiO
's to other equipment, such as a ventilator and/or heart-lung bypass equipment.
2

CONTRAINDICATIONS

While supplemental oxygen therapy is not without possible side effects, such as absorption atelectasis and oxygen toxicity, the detrimental
effects of oxygen shall never prevent its use when indicated
_______________________
Donald F. Eagan, MD, Eagan's Fundamentals of Respiratory Care, Fifth Edition 1999
1

SPECIFICATIONS

Multiple configurations are available, with and without attached flowmeter(s). All models utilize the same gas mixer and therefore the
following specifications apply to all configurations.
Specifications
Outlet Flow Range
Maximum Inlet Flow (psig)
**Bleed Flow
Bypass Alarm Activation
Alarm/Bypass De-activation:
psig
Alarm Sound Level:
Oxygen Concentration
Adjustment Range
Gas Inlet Pressure
Accuracy of Oxygen
Concentration of Delivered
Gas (O
%)
2
Connection Types:
Water Trap Filtration
.
1
High Flow
at least 100 lpm @ at 60% oxygen with inlet
pressures of 50 psig (345 kPa). Inlet range of
30 (+1. -0) psig – 70 (+0. -1) psig produces an
output flow within a range of 70-150 lpm
Maximum inlet flow (psig) is equal to maximum outlet flow (psig) plus maximum bleed flow (psig)
8.0-10.0 lpm @ 16 lpm flow rate
at 50 psig
50 psig (345 Kpa)
24-28 psig (165-193 Kpa)
Inlet gas pressure differential is ≥10 psig (69 kPa).
Minimum of 60 db at 1 ft (0.3 m)
FiO
0.21 to 1.0 (21% - 100% O
)
2
2
50 psig (345 kPa) ± 20 psig (138 kPa) (at 4.0 standard cubic feet per minute (SCFM) min. flow)
± 3% of full scale
Input Fittings: Oxygen female DISS, Air male DISS (NIST available)
Low flow — Oxygen male Barb Fitting
Output Fittings:
High flow — Oxygen DISS Fitting
A 0.01-micron water trap/ filter is provided for the air inlet connection
Page 8 • P/N 100001-EU Rev. 31 (10/2024)
concentrations of .21 to 1.0 for delivery to a variety of respiratory devices
2
% oxygen concentrations between 21% and
2
Low Flow
at least 40 lpm @ at 60% oxygen with inlet
pressures of 50 psig (345 kPa). Inlet range of 30 (+1.
-0) psig – 70 (+0. -1) psig produces an output flow
within a range of 29-60 lpm
2.5-4.5 lpm @ 8 lpm flow rate
at 50 psig
50 psig (345 Kpa)
24-28 psig (165-193 Kpa)
).
2
, (21% to 100% O
) through
2
2

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