SECHRIST 3500 CP-G User manual

P/N 100001 Rev. 26 (Feb 2023)
Air / Oxygen Gas Mixer
USER MANUAL
Sechrist Industries, Inc.
4225 E. La Palma Avenue •Anaheim, CA 92807 •USA
(USA & Canada): 1–800-SECHRIST (732-4747)
Phone: [phone] •Fax: [phone]
Website: www.SechristUSA.com
E-mail: [e-mail]
Registered Address:
Obelis s.a.
Bd. Général Wahis 53
B-1030 Brussels, Belgium Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
Obelis UK Ltd
3 Stoke Row
Henley-On-Thames
United Kingdom RG9 5PL
Phone #: [phone]
Fax #: [phone]
E-mail: [e-mail]
Website: www.obelis.net
FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.

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General Table of Contents
ENGLISH...........................................................................................................................................................1
BULGARIAN / БЪЛГАРСКИ ............................................................................................................................15
CZECH / ČECH ................................................................................................................................................29
DANISH / DANSK............................................................................................................................................42
DUTCH / БЪЛГАРСКИ....................................................................................................................................55
ESTONIAN / EESTI..........................................................................................................................................68
FINNISH / SUOMALAINEN .............................................................................................................................81
FRENCH / FRANÇAIS ......................................................................................................................................94
GERMAN / DEUTSCHE .................................................................................................................................107
GREEK / ΕΛΛΗΝΙΚΑ......................................................................................................................................120
HUNGARIAN / MAGYAR ..............................................................................................................................133
ITALIAN / ITALIANO .....................................................................................................................................146
LITHUANIAN / LIETUVA ...............................................................................................................................159
NORWEGIAN / NORSK.................................................................................................................................172
POLISH / POLSKIE ........................................................................................................................................185
PORTUGUESE / PORTUGUÊS.......................................................................................................................198
ROMANIAN / ROMÂNĂ...............................................................................................................................211
SIMPLIFIED CHINESE / 简体中文 ................................................................................................................224
SLOVAK/ SLOVENSKÝ...................................................................................................................................237
SLOVENIAN / SLOVENŠČINA........................................................................................................................250
SPANISH / ESPAÑOL ....................................................................................................................................263
SWEDISH/ SVENSKA ....................................................................................................................................276
TURKISH / TÜRK...........................................................................................................................................289

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Table of Contents
INTRODUCTION ...............................................................................................................................................5
USER / OWNER RESPONSIBILITY .....................................................................................................................5
WARNINGS & CAUTIONS.................................................................................................................................5
EXPLANATION OF ABBREVIATIONS.................................................................................................................7
EXPLANATION OF SYMBOLS............................................................................................................................7
INDICATIONS FOR USE ....................................................................................................................................8
CONTRAINDICATIONS......................................................................................................................................8
SPECIFICATIONS...............................................................................................................................................8
SETTING UP THE GAS MIXER ...........................................................................................................................9
OPERATING INSTRUCTIONS ............................................................................................................................9
USING THE GAS MIXER WITH OTHER EQUIPMENT.......................................................................................10
PERFORMANCE VERIFICATION......................................................................................................................10
Prior to Each Use .......................................................................................................................................10
Monthly.....................................................................................................................................................10
ROUTINE MAINTENANCE ..............................................................................................................................12
FACTORY OVERHAUL.....................................................................................................................................14
LIFETIME OF DEVICE......................................................................................................................................14
TROUBLESHOOTING ......................................................................................................................................14

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Air / Oxygen Gas Mixer Models
LOW Flow Models
Model 3500CP-G
(pole mount)
Model 20400
Low Flow Model 20459
(pole mount)
Low Flow Model 20457
(wall mount)
HIGH Flow Models
High Flow Model 3600
(pole mount)
High Flow Model 3601
(wall mount)

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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 FiO2 and delivering it to a 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 assure 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
alteration 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 has 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 Mixer models identified in this manual are not standalone devices. These mixers are designed to mix medical grade air and medical
grade oxygen for respiratory care equipment.
WARNING: It is the responsibility of the procuring organization to assure 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 air and O2only; do not modify the inlets to accommodate any 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 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).
WARNING: Liquid water or other contaminants in either inlet gas, particularly in the air inlet, will cause malfunction of this equipment and any attached equipment. Inlet
gases shall meet gas dryness of .0045 mg water per cubic centimeter of gas.
WARNING: Oxygen concentration must be monitored downstream from the gas mixer with a suitable, calibrated oxygen analyzer, equipped with alarms that can be set
for high and low FIO2(O2%). FiO2 (O2%) shall then be adjusted to maintain appropriate blood gas concentrations.
WARNING: Oxygen vigorously accelerates combustion. To avoid explosion hazard, do not expose the gas mixer to any instruments or other equipment that may have
been contaminated by oil or grease. Gas supplied to the gas mixer must be extremely clean (no more than 25 parts per million (ppm) of gaseous hydrocarbons is

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allowed.) A high concentration of hydrocarbons in the gas inlet is a fire hazard.
WARNING: The gas mixer audible alarm may not function when both air and oxygen inlet pressures are less than the minimum specified inlet pressure of 30 psig (207
kPa).
WARNING: The outlets have the capability of providing gas pressures equal to the inlet pressures. Therefore, any attached equipment must provide safety relief
protection to prevent excessive pressures being delivered to patients.
WARNING: Whenever a patient is attached to respiratory care equipment, constant attendance is required by qualified personnel. The use of alarm or monitoring
systems does not provide absolute assurance of a warning for every possible system malfunction. In addition, some problems may require immediate attention.
WARNING: Inlet pressures ≤30 psig (207 kPa) or ≥70 psig (483 kPa) may result in gas mixer damage or malfunction. Use of a suitable inlet gas regulation system is
necessary.
WARNING: A Sechrist Air/Oxygen gas mixer is a sophisticated medical device designed for use by qualified personnel under the direction of a qualified physician.
WARNING: This product shall only be maintained and repaired by a Sechrist Industries factory-trained technician or by written instructions from Sechrist Industries. This
product shall not be modified in any way, except with prior written approval of Sechrist Industries. Unapproved modifications can result in death or serious injury.
WARNING: The gas mixer does not contain gas-sterilizing filters and will inlet the same quality of gas supplied from the gas sources. Use of appropriate gas purity and gas
line filters is the responsibility of the user.
WARNING: When the gas mixer is used to supplement respiratory equipment, the user must refer to and follow the instructions provided by the manufacturer of the
respiratory equipment.
WARNING: Do not obstruct the alarm. Do not tamper with the alarm.
WARNING: Do not use gas mixer when the alarm is sounding.
WARNING: The gas mixer is not suitable for use with oxygen concentrators.
WARNING: The gas mixer bleeds air/oxygen gas mixture. Do not expose gas mixer to ignition sources.
WARNING: When both supplies are within range of 30-70 psig (207-483 kPa), the gas mixer will maintain the delivered oxygen concentration within 1% of the selected
concentration with small fluctuations of the inlet pressure. The additional 2% error results from the readability of the set point and scale error. Do not use on a patient or
with respiratory and heart bypass oxygenation equipment outside of gas mixer pressure specification.
WARNING: Overhaul gas mixer every 2 years from the Date of Manufacture.
WARNING: Visually inspect gas mixer upon receipt. Do not use gas mixer if there is any damage and contact provider.
WARNING: Do not use gas mixer if bubbles are detected during the reverse gas flow test.
WARNING: This precision gas-mixing device may become nonfunctional or damaged if used without the watertrap assembly and filters provided.
WARNING: Periodically replace the air water trap/inlet filter (Sechrist P/N 3529E in Figure 4) at least every 6 months or as needed.
WARNING: Replace the internal sintered stainless-steel filters (Sechrist P/N 3522K in Figure 3) at least every 6 months or as needed.
WARNING: The gas mixer is not MRI compatible.
WARNING: Do not autoclave and/or sterilize.
CAUTION: Do not immerse the gas mixer in any solution.
CAUTION: Before using this gas mixer, verify that the performance verification procedure has been performed by a qualified individual.
CAUTION: The outlet pressure of the gas mixer will always be slightly lower than the lower of the two inlet pressures. Some respiratory equipment attached to the gas
mixer may require closer tolerances; if so, consult with the manufacturer of that equipment.
CAUTION: The bleed flow is located on the bottom of the proportioning module and is necessary to maintain the oxygen concentration accuracy at very low flow settings.
CAUTION: The alarm/bypass will activate when the first gas is connected. The alarm will reset upon the connection to the second gas inlet.
CAUTION: The Air/Oxygen Gas mixer gas pathway has been flushed with oxygen prior to delivery.
CAUTION: indicates the potential of damage to equipment and/or other property if the caution is ignored.
CAUTION: call attention to statements that are intended to supplement or emphasize basic instructions contained within this manual.

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CAUTION: Sechrist air/oxygen mixers are not intended to be single-use devices. They are non-invasive, non-implantable devices.
EXPLANATION OF ABBREVIATIONS
DISS Diameter Index Safety System
NIST Non-Interchangeable Screw Thread
PSIG Pound Per Square Inch Gauge
LPM Liters Per Minute
Air/O2Air/Oxygen
O2% Oxygen Percent
EXPLANATION OF SYMBOLS
SYMBOL
MEANING
Caution
Manufacturer
Date of Manufacture
Reference/Model Number
Serial Number
User/operator to refer to instruction manual
Warning, prohibition, or mandatory action
Caution: Federal law restricts this device to
sale by or on the order of a physician.
Authorized Representative in the European
Community
Medical Device
SYMBOL
MEANING
EU Importer
Do not use if package is damaged
Country of origin

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DANGER
This product is not intended as a life-sustaining or life-supporting device.
Remove the gas mixer from the packaging and inspect for damage. If there is any damage, DO NOT USE and
contact provider.
No electronics are incorporated in the gas mixer.
INDICATIONS FOR USE
The purpose of the device is to enable qualified personnel to mix medical-grade air and medical-grade oxygen, at operator selected oxygen concentrations, for delivery
to patients through various types of respiratory care equipment and cardiopulmonary (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 (FiO2). The gas mixer can provide FIO2concentrations of .21 to 1.0 for delivery to a variety of respiratory devices. The gas mixer receives air and oxygen via
diameter index safety system (D.I.S.S.) inlet connections at a nominal pressure of 50 psig. (344 kPa). The unit will operate satisfactorily with inlet pressures of 30 – 70
psig (207 - 482 kPa) providing that the pressures are within 20 psig (138 kPa) of one another. 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.
•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 FiO2, (21% to 100% O2) through various types of
respiratory care 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 breathing air and medical breathing oxygen to any selected O2% oxygen concentrations between 21% and 100%, for delivery to a variety of
respiratory care equipment.
•Key Performance and Safety Claims: Sechrist Air/Oxygen Mixer is designed to mix medical grade air and medical grade oxygen.
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 1.
_______________________
1 Donald F. Eagan, MD, Eagan’s Fundamentals of Respiratory Care, Fifth Edition 1999
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.
Model
High Flow
Low Flow
Outlet Flow Range
at least 100 lpm @ at 60% oxygen with inlet
pressures of 50 psig (345 kPa). Inlet range of
30-70 psig produces an output flow within a
range of 70-150 lpm
at least 40 lpm @ at 60% oxygen with inlet
pressures of 50 psig (345 kPa). Inlet range of
30-70 psig produces an output flow within a
range of 29-60 lpm
Maximum Inlet Flow
Maximum inlet flow is equal to maximum outlet flow plus maximum bleed flow
**Bleed Flow
8.0-10.0 lpm @ 16 lpm flow rate
at 50 psig
2.5-4.5 lpm @ 8 lpm flow rate
at 50 psig
Bypass Alarm Activation
50 psig (345 Kpa)
50 psig (345 Kpa)
24-28 psig (165-193 Kpa)
24-28 psig (165-193 Kpa)
Alarm/Bypass De-activation:
psig
Inlet gas pressure differential is ≥10 psig (69 kPa).
Alarm Sound Level:
Minimum of 60 db at 1 ft (0.3 m)
Oxygen Concentration
Adjustment Range
0.21 +0.01 to 1.0

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Gas Inlet Pressure
50 psig (345 kPa) ±20 psig (138 kPa) (at 4.0 standard cubic feet per minute (SCFM) min. flow)
Accuracy of Oxygen
Concentration of Delivered
Gas (O
2
%)
± 3% of full scale
Connection Types:
Input Fittings: Oxygen female DISS, Air male DISS (NIST available)
Output Fittings:
Low flow — Oxygen male Barb Fitting
High flow — Oxygen DISS Fitting
Water Trap Filtration
A 0.01-micron water trap/ filter is provided for the air inlet connection
Inlet filtration
Each Air/Oxygen inlet fitting has a 5-micron particulate filter.
Reverse Gas Flow
Reverse gas flow from either gas inlet is prevented by inlet check valves.
Service Life
Two (2) years
Lifetime of Device
The lifetime of Sechrist gas mixers is 20 years provided they are overhauled using Sechrist
supplied components and Sechrist certified technicians once every 2 years.
Optional Accessories
The following operator detachable inlet pressure hoses comply with Compressed Gas
Association (CGA) V-1, V-5, and G-4.1:
•Ref. IV 308 14-foot (4.27 m) Air Inlet Hose (Not available in Europe)
•Ref. IV 309 14-foot (4.27 m) Oxygen Inlet Hose (Not available in Europe)
•Mounting pole
Optional flowmeters
1 – 10 lpm...................... ±3% of full scale
1 – 15 lpm...................... ±3% of full scale
100 - 1000 ml/min......... ±3% of full scale
Inlet gasses shall meet gas dryness of .0045 mg water per cubic centimeter of gas.
Air:
Medical Air inlet should be USP grade or equivalent.
Oxygen:
The oxygen should be USP medical grade oxygen or equivalent.
Dimensions (without flowmeters)
Depth:
≅3.94 inches (without watertrap attached)
Width:
≅2.40 inches
Height:
≅5.16 inches
Weight
≅
4.7 lbs.
Shipping Weight:
≅12 lbs.
Operating Temperature
Range:
80°F ±15°F
SETTING UP THE GAS MIXER
The gas mixer can be either pole or wall mounted. The inlet fittings of the gas mixer conform to Diameter Index Safety System (D.I.S.S.)* and air and oxygen
connections cannot be reversed. Connect an air high pressure hose to the air fitting and an oxygen high pressure hose to the oxygen fitting. It is recommended that an
air inlet water trap be used between the air hose and inlet fitting to prevent moisture from entering the gas mixer.
*The gas mixer is available with inlet NIST fittings and outlet Barb fittings upon request.
OPERATING INSTRUCTIONS
♦ Before using the gas mixer, verify that performance verification has been completed.
♦ If applicable, connect the gas mixer outlet to the inlet device that will be delivering the oxygen concentration to the patient.
♦ From reliable pressure regulated gas sources, connect both medical grade air and medical grade oxygen to the gas mixer inlets utilizing appropriate gas hoses
(P/N IV 308 air inlet hose and P/N IV 309 oxygen inlet hose). NOTE: P/N IV 308 and IV 309 are not CE marked.
♦ Using the gas mixer FiO2control knob, select the desired oxygen concentration FIO2from .21 to 1.0.
♦ If the configuration includes a flowmeter/s, initiate gas flow through the flowmeter(s) by tuning the knob(s) on the flowmeter(s) counterclockwise to the desired
flow setting.
♦ Begin the operation of the attached delivery unit, ifapplicable.
♦ After the selected gas mixture has washed out the room air from the delivery unit, analyze and monitor the delivered gas concentration with a calibrated oxygen
analyzer. Appropriately set the high and low alarm limits on the analyzer.
♦ Periodically observe the watertrap assembly for the accumulation of moisture. Moisture shall be removed from the water trap assembly by depressing the valve
at the bottom of the watertrapbowl.
♦ Periodically observe the oxygen analyzer and evaluate the delivered FIO2.

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USING THE GAS MIXER WITH OTHER EQUIPMENT
 Connect the gas outlet of the gas mixer either directly or via a high-pressure hose to the equipment with which it is being used.
 Set the control on the front panel to the desired oxygen concentration.
 Turn on the 50 psig (345 kPa) air and oxygen sources.
 Use a calibrated oxygen analyzer to check the accuracy of the delivered gas.
PERFORMANCE VERIFICATION
Prior to Each Use
Prior to each clinical usage, the user shall perform the following tests:
•Bypass/alarm system test
oThe user shall briefly disconnect one inlet gas to assure that the bypass/alarm system is functioning. With a single inlet gas disconnected, the audible
alarm shall sound and the analyzed O2%shall indicate the O2%of the single inlet gas, i.e., 21% if the oxygen was disconnected and 100% if the air inlet
was disconnected.
•Accuracy of Oxygen Concentration of Delivered Gas
oWith an accurately calibrated oxygen analyzer, the user shall analyze the O2%at the following settings: 21%, 30%, 40%, 50%, 60%, 70%, 80%, 90% and
100%.
•Reverse Gas Flow Procedure
oReverse gas flow is inspected by supplying pressure to one of the gas supply inlets while a test hose is connected to the other inlet with the free end
submerged in clean water. If bubbles are detected, do not use the gas mixer.
Monthly
The following more extensive procedure shall be performed at least once a month, or more frequently as indicated or desired.
This procedure provides a means of determining if the gas mixer is functioning in accordance with the design specifications. This verification is intended to be performed
in the health care setting by qualified personnel.
The procedure shall be followed exactly as outlined. If the gas mixer fails to meet the established standards, it shall be removed from clinical application until calibration
and/or service is accomplished (see troubleshooting section or service manual)
CAUTION: Personnel responsible for daily and monthly performance verification testing shall keep accurate records of testing activities.
The performance verification process requires a simple configuration as diagramed below.
Figure 2

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 Connect the gas mixer to the inlet gases with independently adjustable pressure regulators (0 – 60 psig).
 Connect a flowmeter to the gas mixer outlet (for models 3600 and 3601 only).
 Direct the flow from the flowmeter to a reservoir (e.g., a bottle or tube) making sure that no room air is being entrained to dilute the mixture.
 Place a calibrated O2 analyzer probe within the reservoir.
Test for overall accuracy
 Set both inlet pressures to 50 psig (344kPa).
 Set the flowmeter to 8 lpm for configurations with the following flowmeters: 0 – 10 lpm and 100-1000 ml/min, 1 –15 lpm, 0 – 16 lpm.
 Set the flowmeter to 15 lpm for configurations with the following flowmeters: 2 – 20 lpm, 2 – 32 lpm, and 3 – 30 lpm.

Compare the O2 analyzer readings at the following settings:21%, 30%, 40%, 50%, 60%, 70%, 80%, 90% and 100%. Since the gas mixer has an overall accuracy of
±3% full scale and if the analyzer accuracy is within ±1%, the FiO2comparisons shall agree within ±4%points.
Test for accuracy with varying inlet pressures.
 Set the O2%to 60% with the inlet pressures at 50 psig (345 kPa).
 Verify the setting accuracy comparing the setting with the analyzed value.
 Set the O2 pressure to 40 psig (276 kPa) leaving the air inlet at 60 psig (414 kPa).
 Note the analyzer reading.
 Set the O2 pressure to 60 psig (414 kPa) and the air inlet to 40 psig (276 kPa)
 Note the analyzer reading.
 Analyzed O2 concentrations shall vary by no more that 2% with the above pressure changes.
Test the alarm module function.
 Set inlet pressures to 50 psig (344kPa).
 Set the O2%to 60%.
 Reduce the air inlet pressure to 24 psig. (166kPa).
 The audible alarm shall sound within the following pressure range of 24-28 psig, and the O2 analyzer shall read greater than 97%.
 Slowly increase the air inlet pressure to 50 psig (345 kPa). The alarm shall cease and reset prior to obtaining a inlet pressure of 40 psig. (276 kPa).
 Reduce the O2 inlet pressure to 24 psig (165kPa).
 The audible alarm shall sound within the following pressure range of 24-28 psig, and the O2 analyzer shall read less than 25%.
 Slowly increase the O2 inlet pressure to 50 psig (345 kPa). The alarm shall cease and reset prior to obtaining a inlet pressure of 40 psig (276 kPa)
Check the inlet filters.
 To test the flow through the water trap filter and air inlet filter assemblies, a small test port has been provided on the rear of the gas mixer just above the
air inlet.
 Turn both inlet gases off and allow the gases to cease flowing. With a ¼ inch hex nut driver, remove the plug from the test port and install a 10-32
threaded nipple.
 Connect an accurate pressure gauge (0-60 psig) (0-414 kPa) to the nipple.
 Turn the inlet gases.
 Set the gas mixer FiO2 control to .21.
 Observe the pressure registered by the gauge connected to the test port.
 The difference between the test gauge pressure and the inlet pressure shall vary by no more than 5 psig (34 kPa).
 If the pressure differential is > 5 psig (34 kPa), replace the inlet filters as outlined in the routine maintenance section.

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ROUTINE MAINTENANCE
NOTE: The manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions, or other information that will
assist trained service personnel to repair those parts of medical equipment that are designated by the manufacturer as repairable by service personnel.
Routine maintenance of the gas mixer is limited to periodic performance verification, replacement of the inlet filters and cleaning of the exterior surfaces. A gas mixer
in need of calibration or service shall not be used until the necessary procedures are performed and the equipment has been tested to determine that it is functioning
properly. Calibration and servicing may only be accomplished by personnel trained and authorized to do so by Sechrist Industries. Routine maintenance, as defined in
this manual, may be performed by a competent individual having experience in the maintenance of devices of this nature. Parts designated within this manual shall be
replaced only with parts manufactured or sold by Sechrist Industries.
 Inlet filters
 Periodically replace the air water trap/inlet filter (Sechrist P/N 3529E in Figure 4) at least every 6 months or as needed.
 Replace the internal sintered stainless-steel filters (Sechrist P/N 3522K in Figure 3) at least every 6 months or as needed.
 Cleaning
 Exterior surfaces of the gas mixer may be wiped clean with a mild soap solution or a liquid disinfectant solution. Do not use cleaning agents that contain
abrasives.

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Figure 3
Figure 4

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FACTORY OVERHAUL
To assure proper function and accuracy, the Sechrist Air/Oxygen gas mixers must be thoroughly overhauled every two (2) years. To maintain the product
warranty, the overhaul must be performed by Sechrist Industries or by Sechrist authorized personnel.
LIFETIME OF DEVICE
The lifetime of Sechrist Air/Oxygen gas mixers is 20 years provided they are overhauled using Sechrist supplied components and Sechrist certified technicians once
every 2 years.
TROUBLESHOOTING
Problem
Possible Cause
Correction
Inaccurate O2%
O
2
analyzer out of calibration (most
common problem).
Recalibrate O2 analyzer.
Improper purity of inlet gases. Check/verify inlet gas purity.
Incorrect gas supplied to inlet. Assure that outlets and hoses are connected correctly.
Front and rear seats are worn. Recalibrate gas mixer (shall be performed only by Sechrist Industries or by
Sechrist authorized personnel).
Incorrect calibration of proportioning module.
Malfunctioning balancing module. Recalibrate the balancing module (shall be performed only by Sechrist
Industries or by Sechrist authorized personnel).
O2%control knob is difficult to
turn.
Faceplate has shifted. Reposition faceplate.
Bent adjustment shaft. Replace shaft and recalibrate (shall be performed only by Sechrist
Industries or by Sechrist authorized personnel).
O2%change > 1%
when testing.
Air or O
2
inlet filter may be dirty causing
a > 20 psig
(138 kPa) difference.
Replace inlet filter.
Regulator needle out of calibration. Recalibrate gas mixer (shall be performed only by Sechrist Industries or by
Sechrist authorized personnel).
Continuous alarm with both
inlet pressures equal.
Dirty inlet filter(s). Replace filter(s).
Bypass check ball leaking. Clean check ball and seat (shall be performed only by Sechrist Industries or by
Sechrist authorized personnel).
Alarm module out of calibration. Recalibrate (shall be performed only by Sechrist Industries or by Sechrist
authorized personnel).
Alarm not sounding with the
loss of pressure from
one source gas.
Defective alarm reed. Replace alarm reed (shall be performed only by Sechrist Industries or by
Sechrist authorized personnel).
Alarm module out of calibration. Recalibrate gas mixer (shall be performed only by Sechrist Industries or by
Sechrist authorized personnel).
Alarm poppets stuck.
Clean, lubricate poppets and recalibrate as outlined in the service manual
(shall be performed only by Sechrist Industries or by Sechrist authorized
personnel).
CAUTION: If the problem or concern continues after taking the appropriate correction, consult an authorized Sechrist service representative or
contact Sechrist Industries Technical Support.

P/N 100001 Ред. 26 (февруари 2023 г.)
Газов миксер въздух/кислород
РЪКОВОДСТВО ЗА УПОТРЕБА
Sechrist Industries, Inc.
4225 E. La Palma Avenue •Anaheim, CA 92807 •USA
(САЩ & Канада): 1–800-SECHRIST (732-4747)
Телефон: [phone] •Факс: [phone]
Уебсайт: www.SechristUSA.com
E-mail: [e-mail]
Седалище и адрес на управление:
Obelis s.a.
Bd. Général Wahis 53
B-1030 Brussels, Belgium
Телефон: [phone]
Факс: [phone]
E-mail: [e-mail]
Obelis UK Ltd
3 Stoke Row
Henley-On-Thames
United Kingdom RG9 5PL
Телефон: [phone]
Факс [phone]
E-mail: [e-mail]
Уебсайт: www.obelis.net
ФЕДЕРАЛНОТО ЗАКОНОДАТЕЛСТВО (САЩ) ПОЗВОЛЯВА ПРОДАЖБАТА НА ТОВА УСТРОЙСТВО САМО ОТ ЛЕКАР И
ИЛИ ПО ЛЕКАРСКО ПРЕДПИСАНИЕ.

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Съдържание
ВЪВЕДЕНИЕ...................................................................................................................................................18
ОТГОВОРНОСТ НА ПОТРЕБИТЕЛЯ/СОБСТВЕНИКА.....................................................................................18
ПРЕДУПРЕЖДЕНИЯ И СЪОБЩЕНИЯ ЗА ВНИМАНИЕ..................................................................................18
ОБЯСНЕНИЕ НА СЪКРАЩЕНИЯТА ...............................................................................................................20
ОБЯСНЕНИЕ НА СИМВОЛИТЕ......................................................................................................................20
УКАЗАНИЯ ЗА УПОТРЕБА.............................................................................................................................21
ПРОТИВОПОКАЗАНИЯ .................................................................................................................................21
СПЕЦИФИКАЦИИ..........................................................................................................................................21
НАСТРОЙКА НА ГАЗОВИЯ МИКСЕР.............................................................................................................22
ИНСТРУКЦИИ ЗА ЕКСПЛОАТАЦИЯ..............................................................................................................22
ИЗПОЛЗВАНЕ НА ГАЗОВИЯ МИКСЕР С ДРУГО ОБОРУДВАНЕ....................................................................24
ПРОВЕРКА НА ФУНКЦИОНАЛНОСТТА ........................................................................................................24
Преди всяка употреба .............................................................................................................................24
Ежемесечно..............................................................................................................................................24
ПРОФИЛАКТИЧНА ПОДДРЪЖКА ................................................................................................................25
ФАБРИЧЕН ПРЕГЛЕД ....................................................................................................................................28
ЕКСПЛОАТАЦИОНЕН СРОК НА УСТРОЙСТВОТО ........................................................................................28
ОТСТРАНЯВАНЕ НА ПРОБЛЕМИ..................................................................................................................28

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Модели – Газови миксери въздух/кислород
НИСКОДЕБИТНИ модели
Модел 3500CP-G
(за монтаж на стойка)
Модел 20400
Нискодебитен модел 20459
(за монтаж на стойка)
Нискодебитен модел 20457
(за стенен монтаж)
ВИСОКОДЕБИТНИ модели
Високодебитен модел 3600
(за монтаж на стойка)
Високодебитен модел 3601
(за стенен монтаж)

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Ние от Sechrist Industries, Inc. Ви благодарим, че избрахте Sechrist газов миксер въздух/кислород. Също така Ви предупреждаваме, че преди да се опитате да
използвате газовия миксер за грижа за пациенти, трябва да сте напълно запознати с инструкциите в това упътване и етикетите по продукта. В това упътване
предупрежденията, бележките за внимание и забележките ще се използват, за да привлекат вниманието Ви към особено важните неща.
ВЪВЕДЕНИЕ
Газовият миксер е прецизен дозиращ уред за смесвате на медицински въздух с кислород до всяка концентрация от 0,21 до 1,0 FiO2за подаване към различни
обдишващи уреди. Газовият миксер използва медицински въздух и кислород при налягане от 50 psig (345 kPa), свързани към два DISS фитинга. Газовият миксер
използва двуетапна система за балансиране, като газът навлиза в първия етап, за да изравни работното налягане на газовите източници, преди да навлезе в етапа
на дозиране. След това газовете се вливат в етапа на дозиране, където се смесват до концентрацията на кислород, зададена с помощта на копчето за управление
на газовия миксер. На този етап е наличен двустранен клапан с клапанни легла от двата края. Всяко едно от тези легла на клапана контролира преминаването на
въздуха или кислорода към изхода на газовия миксер.
Газовите миксери се предлагат в конфигурации с нисък или висок дебит. Газовите миксери също се предлагат в различни конфигурации за входно/изходните
конектори.
ОТГОВОРНОСТ НА ПОТРЕБИТЕЛЯ/СОБСТВЕНИКА
ПРЕДУПРЕЖДЕНИЕ: Отговорност на снабдителя е да се погрижи да осигури инструментариума, оборудването и обучението, които са
необходими за извършването на операциите, за които се предоставят компонентите или комплектите от снабдителя.
ПРЕДУПРЕЖДЕНИЕ: Болниците или потребителите, които извършват определени видове поправки и/или периодично обслужване на
оборудването, без да са преминали обучението на Sechrist Industries сами ще носят отговорност за всяка неизправност, възникнала в
резултат на неправилна употреба, неподходяща поддръжка, неправилна или неоторизирана поправка, повреда или промяна.
Газовият миксер Sechrist ще работи според спецификациите и описанията в това ръководство и придружаващите го етикети, когато се експлоатира и поддържа
в съответствие с инструкциите в това ръководство и друга придружаваща го документация. Не се опитвайте да експлоатирате това устройство преди да сте
прочели и напълно разбрали тези инструкции. Газовият миксер трябва да се проверява периодично, както е указано в това ръководство (виж раздел
Профилактична Поддръжка). Никога не трябва да се употребява дефектен продукт в клинична среда. Всяка необходима поправка трябва да се извършва в
офисите на Sechrist в Анахайм, Калифорния или от човек, обучен и упълномощен от Sechrist Industries. Sechrist обаче допуска, че някои болници и други
потребители разполагат със свои собствени групи за обслужване на оборудването (биомедицински инженери и техници), които извършват определени видове
поправки и/или периодично обслужване. Sechrist не предоставя резервни компоненти и комплекти за такива цели.
ПРЕДУПРЕЖДЕНИЕ: Сериозни инциденти, смъртни случаи и неизправности, възникнали във връзка с устройството, трябва да бъдат
докладвани от потребителя на Sechrist и компетентния орган на държавата членка, в която е установен потребителят и/или пациентът.
ПРЕДУПРЕЖДЕНИЯ И СЪОБЩЕНИЯ ЗА ВНИМАНИЕ
ПРЕДУПРЕЖДЕНИЕ: Посочва възможността за собствено нараняване или смърт на пациента и/или оператора на уреда.
ПРЕДУПРЕЖДЕНИЕ: Моделите миксери за въздух/кислород Sechrist, посочени в това ръководство, не са самостоятелни устройства. Тези миксери са
предназначени за смесване на медицински въздух и медицински кислород за оборудване за обдишване.
ПРЕДУПРЕЖДЕНИЕ: Отговорност на снабдителя е да се погрижи да осигури инструментариума, оборудването и обучението, които са необходими за
извършването на операциите, за които се предоставят компонентите или комплектите от снабдителя.
ПРЕДУПРЕЖДЕНИЕ: Не са разрешени промени на това оборудване. Не променяйте това оборудване без разрешение от производителя. Ако това оборудване е
било променено, трябва да се извърши подходяща проверка и тестване, за да се гарантира последващото безопасно използване на оборудването.
ПРЕДУПРЕЖДЕНИЕ: Газовият миксер е предназначен да миксира въздух и O2; не модифицирайте входовите отвори за всякакви други газови източници.
ПРЕДУПРЕЖДЕНИЕ: Болниците или потребителите, които извършват определени видове поправки и/или периодично обслужване на оборудването, без да са
преминали обучението на Sechrist Industries сами ще носят отговорност за всяка неизправност, възникнала в резултат на неправилна употреба, неподходяща
поддръжка, неправилна или неоторизирана поправка, повреда или промяна.
ПРЕДУПРЕЖДЕНИЕ: Потребителят на Sechrist газов миксер въздух/кислород носи еднолична отговорност за всички неизправности, възникнали в резултат на
неправилна употреба, неподходяща поддръжка, неправилни и/или неоторизирани поправки, повреди или промени, извършени от неупълномощени от
Sechrist Industries лица.
ПРЕДУПРЕЖДЕНИЕ: Не използвайте високодебитни газови миксери за новородени и педиатрични пациенти.
ПРЕДУПРЕЖДЕНИЕ: Аларма/байпас условията трябва да се поправят бързо, тъй като избраната концентрация на кислород няма да бъде доставена при условие
на байпас. Разликата в налягането между източниците на газ на въздуха и кислорода трябва да се поддържа в рамките на 20 psig (138 kPa).
ПРЕДУПРЕЖДЕНИЕ: Вода или други замърсители, в което и да е подаване на газ, особено в подаването на въздух, ще предизвикат неизправност в на
оборудването и всички прикрепени към него уреди. Подаваните газове трябва да имат сухота от 0,0045 мг вода на кубичен сантиметър газ.

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ПРЕДУПРЕЖДЕНИЕ: Концентрацията на кислород трябва да се наблюдава надолу по потока от газовия миксер с подходящ калибриран анализатор за въздух,
снабден с аларми, които могат да се настроят за висок и нисък FiO2(O2%). FiO2(O2%) трябва да се настрои, за да поддържа подходящата концентрация на газ в
кръвта.
ПРЕДУПРЕЖДЕНИЕ: Кислородът е силно възпламеним. За да избегнете опасността от взривяване, не излагайте газовия миксер на никакви инструменти или
друга екипировка, която може да е била замърсена от петрол или масло. Подаваният към газовия миксер газ трябва да е изключително чист (позволяват се не
повече от 25 части газови хидрокарбонати в милион (ppm)). Висока концентрация на хидрокарбонати в газовото подаване е пожароопасна.
ПРЕДУПРЕЖДЕНИЕ: Звуковата аларма на газовия миксер може да не функционира, когато подаващите налягания и на въздуха, и на кислорода са по-малко от
минималното указано налягане на входовия отвор, което е 30 psig (207 kPa).
ПРЕДУПРЕЖДЕНИЕ: Изпускателните отвори имат възможността да осигуряват газови налягания, равни на тези във входовите. Затова всяко прикрепено
оборудване трябва да осигурява протекция от освобождаване на предпазителя, за да предотврати излишни налягания към пациентите.
ПРЕДУПРЕЖДЕНИЕ: Когато пациентът бъде поставен на устройство за обдишване, е необходимо постоянно наблюдение от квалифициран персонал.
Употребата на аларма или системи за наблюдение не осигурява пълна сигурност в предупрежденията за всяка възможна неизправност в системата. В
допълнение, някои проблеми могат да изискват незабавна намеса.
ПРЕДУПРЕЖДЕНИЕ: Подавано налягане ≤ 30 psig (207 kPa) или ≥ 70 psig (483 kPa) може да причини повреда или неизправност в газовия миксер. Необходима е
употребата на подходяща система за регулация на подаването на газ.
ПРЕДУПРЕЖДЕНИЕ: Sechrist газовият миксер въздух/кислород е сложен медицински уред, предназначен за употреба от квалифициран персонал под
ръководството на квалифициран лекар.
ПРЕДУПРЕЖДЕНИЕ: Този продукт трябва да се поддържа и поправя само от техник, обучен във фабриките на Sechrist Industries или чрез писмени инструкции от
Sechrist Industries. Този продукт не трябва да се модифицира по никакъв начин, освен с предварителното писмено съгласие на Sechrist Industries. Неодобрени
модификации могат да причинят смърт или сериозни наранявания.
ПРЕДУПРЕЖДЕНИЕ: Газовият миксер не съдържа филтри, стерилизиращи газа, и ще подава същото качество газ, подадено от източниците. Употребата на
подходяща чистота на газа и филтри за газовата линия е отговорност на потребителя.
ПРЕДУПРЕЖДЕНИЕ: Когато газовият миксер се използва за поддръжка на дихателни уреди, потребителят трябва да се консултира и да следва инструкциите,
предоставени от производителя на дихателния уред.
ПРЕДУПРЕЖДЕНИЕ: Не възпрепятствайте алармата. Не нарушавайте алармата.
ПРЕДУПРЕЖДЕНИЕ: Не използвайте газовия миксер при включена аларма.
ПРЕДУПРЕЖДЕНИЕ: Газовият миксер не е подходящ за използване с кислородни концентратори.
ПРЕДУПРЕЖДЕНИЕ: Газовият миксер изпуска газова смес въздух/кислород. Не излагайте газовия миксер на източници на възпламеняване.
ПРЕДУПРЕЖДЕНИЕ: Когато и двете доставки са в диапазона от 30–70 psig (207–483 kPa), газовият миксер ще поддържа доставената концентрация на кислород в
рамките на 1% от избраната концентрация с малки колебания на входното налягане. Допълнителната грешка от 2% е в резултат от четливостта на отправната
точка и скалата. Не използвайте при пациент или с оборудване за дихателна и сърдечна байпасна оксигенация извън спецификацията за налягане на газовия
миксер.
ПРЕДУПРЕЖДЕНИЕ: Ремонтирайте газовия миксер на всеки 2 години от датата на производство.
ПРЕДУПРЕЖДЕНИЕ: Визуално проверете газовия миксер при получаване. Не използвайте газовия миксер, ако има повреда и се свържете с доставчика.
ПРЕДУПРЕЖДЕНИЕ: Не използвайте газовия миксер, ако се открият мехурчета по време на теста за обратен дебит на газа.
ПРЕДУПРЕЖДЕНИЕ: Този прецизен газосмесителен уред може да спре да функционира или да се повреди, ако се използва без предоставените водосъбирател и
филтри.
ПРЕДУПРЕЖДЕНИЕ: Периодично заменяйте въздушно-водния събирател/входния филтър (Sechrist P/N 3529E на Фигура 4) поне на всеки 6 месеца или при нужда.
ПРЕДУПРЕЖДЕНИЕ: Сменяйте вътрешните металокерамични филтри от неръждаема стомана (Sechrist P/N 3522K на Фигура 3) поне на всеки 6 месеца или при
нужда.
ПРЕДУПРЕЖДЕНИЕ: Газовият миксер не е съвместим с ЯМР.
ПРЕДУПРЕЖДЕНИЕ: Не автоклавирайте и/или стерилизирайте.
ВНИМАНИЕ: Не потапяйте газовия миксер в никакви разтвори.

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ВНИМАНИЕ: Преди да използвате този газов миксер, уверете се, че процедурата за проверка на функционалността е била изпълнена от квалифициран
персонал.
ВНИМАНИЕ: Налягането на изходният отвор на газовия миксер винаги ще бъде малко по-ниско от по-ниското от двете подавани налягания. Някои обдишващи
уреди, прикрепени към газовия миксер, може да изискват по-близки толеранси; ако е така, консултирайте се с производителя на тези уреди.
ВНИМАНИЕ: Потокът на кръвта се намира на дъното на разделителния модул и е необходим, за да се поддържа акуратността на концентрацията на кислорода
при много ниски настройки на потока.
ВНИМАНИЕ: Алармата/байпас ще се активира, когато се свърже първият газ. Алармата ще се рестартира при свързване на втория газов източник.
ВНИМАНИЕ: Пътят на газовия миксер въздух/кислород е промит с кислород преди доставката.
ВНИМАНИЕ: Посочва възможна повреда в оборудването и/или друга собственост, ако се пренебрегне съобщението за внимание.
ВНИМАНИЕ: Обръща внимание на изречения, които имат за цел да допълнят или да подчертаят основните инструкции в това ръководство.
ВНИМАНИЕ: Миксерите въздух/кислород Sechrist не са предназначени да бъдат устройства за еднократна употреба. Те са неинвазивни, неимплантируеми
устройства.
ОБЯСНЕНИЕ НА СЪКРАЩЕНИЯТА
DISS Система за безопасност по индекс на диаметъра
NIST Невзаимозаменяема винтова резба
PSIG Калибър паунд на квадратен инч
LPM Литри в минута
Air/O2Въздух/кислород
O2% Процент кислород
ОБЯСНЕНИЕ НА СИМВОЛИТЕ
СИМВОЛ
ЗНАЧЕНИЕ
Внимание
Производител
Дата на производство
Референтен номер/номер на модела
Сериен номер
Потребителят/операторът трябва да се
обърне към ръководството с инструкции
Предупреждение, забрана или
задължително действие
Внимание: Федералното законодателство
на САЩ позволява продажбата на това
устройство само от лекари или по лекарско
предписание.
Оторизиран представител за Европейската
общност
Медицинско изделие
СИМВОЛ
ЗНАЧЕНИЕ
Вносител за ЕС
Не използвайте, ако опаковката е
повредена
Страна на произход