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Sechrist Industries, Inc. thanks you for choosing a Sechrist Air/Oxygen gas mixer. We also caution you that before attempting to use the gas mixer in a
patient care setting, you must make yourself thoroughly familiar with the instructions in this manual and any product labeling. Throughout this
manual, warnings, cautions and notes will be utilized to bring your attention to particularly important matters.
INTRODUCTION
The gas mixer is a precision proportioning device for mixing medical grade air and oxygen to any concentration from .21 to 1.0 FiO
and delivering it to a
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variety of respiratory care devices. The gas mixer uses medical grade air and oxygen at a pressure of 50 psig (345 kPa) connected to two D.I.S.S. fittings. The
gas mixer uses a double stage balancing system with the gas entering the first stage to equalize the operating pressure of the gas sources before entering
the proportioning stage. The gases then flow into the proportioning stage where they are mixed to the oxygen concentration set using the gas mixer control
knob. This stage has a double-ended valve with valve seats on either end. Each one of these valve seats controls the passage of the air or oxygen to the
outlet of the gas mixer.
The gas mixers are available in low flow or high flow configurations. The gas mixers also are available in various configurations for the input/output
connectors.
USER / OWNER RESPONSIBILITY
WARNING: It is the responsibility of the procuring organization to ensure they have the tooling, equipment and training necessary
to perform the tasks they are procuring components or kits for.
WARNING: Hospitals or users who perform certain repairs and/or periodic service without undergoing training by Sechrist
Industries assumes sole responsibility for any malfunction, which results from improper usage, faulty maintenance, improper or
unauthorized repairs, damage or a l t e r a t i o n performed.
The Sechrist gas mixer will perform in accordance with the specifications and descriptions contained within this manual and accompanying labeling
when the gas mixer is operated and maintained in accordance with the instructions contained within this manual and other accompanying
documentation. Do not attempt to operate this equipment before reading and thoroughly understanding these instructions. The gas mixer shall be
checked periodically as specified within this manual (see Routine Maintenance Section). A defective product shall never be used in a clinical setting.
Any necessary repair shall be provided at the Sechrist home offices in Anaheim, CA or by an individual trained and authorized by Sechrist Industries.
However, Sechrist recognizes that some hospitals and other users maintain their own service groups (biomedical engineers and technicians) who
perform certain repairs and/or periodic service. Given this, Sechrist does provide spare components and kits for such effort.
WARNING: Serious incidents, deaths, and malfunctions that have occurred in relation to the device must be reported by the user to
Sechrist and the Competent Authority of the Member State in which the user and/or patient is established.
WARNINGS & CAUTIONS
WARNING: indicates the possibility of personal injury or death to the patient and/or operator of the device.
WARNING: The Sechrist Air/Oxygen Gas Mixer models identified in this manual are not standalone devices. These gas mixers are designed to mix
medical grade air and medical grade oxygen for delivery to various respiratory care and heart-lung bypass equipment.
WARNING: It is the responsibility of the procuring organization to assure them they have the tooling, equipment, and training necessary to perform
the tasks they are procuring components or kits for.
WARNING: No modification of this equipment is allowed. Do not modify this equipment without authorization from the manufacturer. If this
equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment.
WARNING: The gas mixer is designed to mix medical grade air and medical grade oxygen (O
), only; do not modify the inlets to accommodate any
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other source gases.
WARNING: Hospitals or users who perform certain repairs and/or periodic service without undergoing training by Sechrist Industries assumes sole
responsibility for any malfunction, which results from improper usage, faulty maintenance, improper or unauthorized repairs, damage or alteration
performed.
WARNING: The user of the Sechrist Air/Oxygen Gas Mixer shall have sole responsibility for any malfunction, which results from improper usage, faulty
maintenance, improper and/or unauthorized repairs, damage or alteration performed by anyone other than Sechrist Industries.
WARNING: Do not use Sechrist high flow gas mixers for neonate and pediatric patients.
WARNING: Alarm/bypass conditions must be corrected swiftly, as the selected oxygen concentration will not be delivered during a bypass situation.
The pressure differential between the air and oxygen inlet gas sources must be kept within 20 psig (138 kPa).
Page 4 • P/N 100001-EU Rev. 31 (10/2024)
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