Maxtec MaxFLO2 User manual

MaxFLO2™
OPERATING MANUAL &
INSTRUCTIONS FOR USE
LOW FLOW
R223P01
R223M01 REV. G

866.4.Maxtec www.maxtec.com I
Maxtec TEL:[phone]
2305 South 1070 West FAX:[phone]
Salt Lake City, Utah 84119 EMAIL:[email protected]
USA WEBSITE:www.maxtec.com
Authorized Representative:
QNET BV
Kantstraat 19
NL-5076 NP Haaren
The Netherlands
EC REP
NOTE: The MaxFLO2is for use only by trained personnel. Before use, all individuals using the
MaxFLO2should become familiar with the information contained in this Operating Manual.
Adherence to these instructions is necessary for safe, effective product performance. Thoroughly
read all instructions and labelling provided with this device and any other equipment that will
be used.
INDICATIONS FOR USE
The MaxFLO2is designed to provide intermittent or continuous controlled flows of an air/oxygen
gas mixture to infant, pediatric, and adult patients. The MaxFLO2is intended to be used with a
Maxtec Oxygen Analyzer as a spot checking device. The MaxFLO2is a restricted medical device
intended for use by qualified trained personnel under the direction of a physician in institutional
environments where delivery and monitoring of air/oxygen mixtures are required.
CONTRAINDICATIONS
The MaxFLO2is not intended for use as a life support device.
WARRANTY
Under normal operating conditions, Maxtec warrants the MaxFLO2to be free from defects
of workmanship or materials for a period of 3 years from the date of shipment from Maxtec,
provided that the unit is properly operated and maintained in accordance with Maxtec’s operating
instructions. Based on Maxtec product evaluation, Maxtec’s sole obligation under the foregoing
warranty is limited to making replacements, repairs, or issuing credit for equipment found to be
defective. This warranty extends only to the buyer purchasing the equipment directly from Maxtec
or through Maxtec’s designated distributors and agents as new equipment.
Routine maintenance items are excluded from warranty. Maxtec and any other subsidiaries
shall not be liable to the purchaser or other persons for incidental or consequential damages
or equipment that has been subject to abuse, misuse, misapplication, alteration, negligence or
accident.
These warranties are exclusive and in lieu of all other warranties, expressed or implied, including
warranty of merchantability and fitness for a particular purpose.

866.4.Maxtec www.maxtec.comII
WARNINGS
Indicates a potentially hazardous situation which, if not avoided, could result in
death or serious injury.
DO NOT use the MaxFLO2in an MRI environment.
DO NOT use the MaxFLO2as a life support device.
• The MaxFLO2DOES NOT CONTAIN AUDIBLE OR VISUAL ALARMS. Loss of a gas
source or a drop of gas pressure below functional levels (25 PSI) is determined
visually by monitoring individual gas flows.
DO NOT use the MaxFLO2to provide mixed gas to other devices which require a
pressurized gas. The MaxFLO2DOES NOT SUPPLY A PRESSURIZED GAS MIXTURE.
DO NOT use the MaxFLO2near any type of open flame.
• The MaxFLO2is only for use with oxygen and medical air.
• Always operate the MaxFLO2with clean, dry medical grade gases. Contaminates or
moisture can cause defective operation. Oxygen should have a minimum dew point
of -80°F (-62°C) or moisture content less than 7.9 ppm (0.0059 mg/L). Oxygen
“purity” should be at least 99.6% and air used should be medical grade. Water
vapor content must not exceed a dew point of 5°F (-15°C) below the lowest ambient
temperature to which the delivery system is exposed. Particulate content must not
exceed that which would be found immediately downstream of a 15 micron absolute
filter. Refer to CGA commodity specifications G4.3 and G7.1 for more information.
Water vapor content of medical air or oxygen supply to the MaxFLO2must not exceed
5.63 x 103 mg/m3 H2O of non-condensable gas.
• The MaxFLO2should only be used under proper supervision from a
healthcare professional.
• Consult a physician for appropriate FiO2settings.
• The oxygen concentration selection table in this operating manual is provided only as
a guideline for selecting oxygen concentration. Verify oxygen concentrations using an
analyzer/monitor which can be calibrated.
DO NOT autoclave or expose the MaxFLO2to high temperatures (>65°C).
DO NOT use ethylene oxide sterilization.
DO NOT expose the MaxFLO2to pressures greater than 100 PSI.
DO NOT disconnect gas hoses from the MaxFLO2while the device is under pressure.
CAUTIONS
Indicates a potentially hazardous situation which, if not avoided, could result in
minor or moderate injury and property damage.
• Use caution when using the MaxFLO2in the presence of flammable anesthetics or in
an atmosphere of flammable gases when the O2concentration exceeds 30%. Maxtec
recommends following hospital anesthetic gas guidelines*.
• Before use on a patient, the oxygen concentration of the delivered gas should be
checked at the setting intended for use.
• The MaxFLO2is designed for use with a gas analyzer/monitor for continuous or
intermittent gas analysis. Maxtec recommends use of an oxygen analyzer/monitor,
which can be calibrated, whenever the MaxFLO2is in use.
• Use caution when using the Mixed Gas Analysis Port to ensure the analyzer/
monitor does not become unintentionally or accidentally dislodged. The MaxFLO2is
optimized for use with flow diverters from Maxtec analyzers/monitors.
Do not insert flow diverters into the Mixed Gas Analysis port which are not connected
to an analyzer/monitor.
!

866.4.Maxtec www.maxtec.com III
• Variations in inlet gas source pressure will change the flow rate of the affected gas
and alter the percent of oxygen exiting the outlet.
• Excessive back pressure on the outlet will result in higher than indicated gas flow but
will not result in inaccurate oxygen concentration.
• Use caution to ensure the mixed gas analysis port is clean and free of any foreign
matter before each use.
• Maxtec recommends use of Maxtec analyzers/monitors which contain the Maxtec
MAX-250 line of sensors. The use of analyzers/monitors with other brands or types of
sensors may result in performance that does not conform to specifications found in
Table 1 of Section 2.2 and information found in Section 12 of this operating manual.
• Clean the MaxFLO2as recommended in section 5 of this operating manual.
Excessive cleaning can cause residue buildup on critical components which can
affect the performance of the MaxFLO2.
Do not clean the MaxFLO2with cleaning agents that contain phenols, ammonia
chloride, or chloride compounds, or that contain more than 2% glutaraldehyde. These
agents may damage the plastic components.
Do not operate the MaxFLO2at pressures below 25 PSIG (170kPaG) or above 75 PSIG
(520kPaG).
• Mount the MaxFLO2vertically and securely for correct performance. Check for
proper function as outlined in section 3 of this operating manual prior to first use.
• Dropping the device may cause injury or device damage. If the MaxFLO2is
dropped, follow the procedures outlined in Section 3 of this operating manual for a
performance check before re-using the device.
• An air inlet water filter is recommended for use with the MaxFLO2.
Do not overtighten the flow adjustment valves.
• Use only Maxtec replacement parts. Failure to do so may seriously impair the
performance of the MaxFLO2. Repair or alteration of the MaxFLO2by anyone other
than an authorized Maxtec service representative, could cause the product to fail to
perform as designed.
* References:
1. New clinical guide to surgical fire prevention. Health Devices. 2009;38(10):314-332.
2. Accidents happen - an immediate action plan. The ECRI Institute website. Available at: https://www.ecri.
org/Products/PatientSafetyQualityRiskManagement/CustomizedServices/Pages/Immediate_Action_Plan.aspx
Accessed November 2, 2009.
NOTES
Indicates supplemental information to assist in use of the device.
• There are no user serviceable components inside the MaxFLO2. All service should be
referred to a Maxtec trained service technician or to Maxtec.
• The MaxFLO2is tested for compliance with ISO 11195:1995, clause 6, and meets
requirements regarding reverse gas flow as delivered.
• The MaxFLO2has been cleaned and degreased for oxygen service prior to shipment.
Any lubricants used are designed specifically for the application. Do not use anything
other than Maxtec specified lubricants when servicing the MaxFLO2. Never use oils
on the MaxFLO2.
• Users are advised to use pressure regulators set to 50 ± 5 PSIG (345 ± 35 kPaG)
which display system pressure.
• All specifications assume the following standard environmental conditions unless
otherwise specified: ambient and sample gas temperatures of 77°F (25°C),
barometric pressure of 1 atm (101 kPa), ambient relative humidity of 50%, sample
gas relative humidity of 0%.

866.4.Maxtec www.maxtec.comIV
TABLE OF CONTENTS
Indications for Use ................................................... I
Contraindications .................................................... I
Warranty........................................................... I
Warnings ..........................................................II
Cautions ...........................................................II
Notes ............................................................ III
1.0 SYSTEM OVERVIEW................................................1
1.1 Description ....................................................1
1.2 Component Identification .........................................1
1.3 Component Description...........................................2
1.4 Symbol Guide ..................................................2
1.5 Operational Requirements.........................................2
2.0 OPERATING INSTRUCTIONS ..........................................2
2.1 Installation of Pole Mount MaxFLO2..................................2
2.2 Setting Flow and Oxygen Concentration...............................3
2.3 Mixed Gas Analysis Port Function and Use Procedure....................4
3.0 PERFORMANCE CHECK..............................................4
4.0 TROUBLESHOOTING ................................................6
5.0 CLEANING .......................................................6
6.0 SERVICE AND MAINTENANCE .........................................6
7.0 ABBREVIATION GUIDE ..............................................7
8.0 SPECIFICATIONS ..................................................7
9.0 FACTORS INFLUENCING CALIBRATION WHEN USING THE MIXED GAS
ANALYSIS PORT......................................................7
9.1 Flow Rate Effect ................................................7
9.2 Temperature Effect ..............................................8
9.3 Pressure Effect .................................................8
9.4 Humidity Effect.................................................8
10.0 SPARE PARTS AND ACCESSORIES.....................................8
10.1 Included with Your Unit..........................................8
10.2 Spare parts...................................................8
10.3 Optional Accessories............................................8
11.0 THEORY OF OPERATION ............................................9
11.1 Mixing Operation...............................................9
11.2 Mixed Gas Analysis Port and Sampling Chamber......................10
11.3 Mixed Gas Outlet .............................................10
12.0 FLOW CHARACTERISTICS ..........................................10
12.1 Maximum Flow ...............................................10
12.2 Minimum Flow ...............................................10
12.3 Back Pressure Effect on Low Flow MaxFLO2.........................11

866.4.Maxtec www.maxtec.com 1
1.0 SYSTEM OVERVIEW
1.1 Description
The MaxFLO2is a compact air/oxygen gas mixing device. The MaxFLO2provides
precise mixing of medical grade air and oxygen through two separate gas flowmeters
controlled by two separate flow control knobs. The sum of each individual gas flow
yields the total flow of gas, i.e. 5 LPM of oxygen and 8 LPM of air is a total flow of 13
LPM. Resulting oxygen concentration can be determined in several ways:
• With use of an oxygen analyzer/monitor mounted to the mixed gas
analysis port.
• Referencing Table 1 in Section 2.2 of this Operating Manual.
Additional features and operational benefits include:
• Quick and easy intermittent or continuous oxygen measurements.
• No continuous bleed required, less wasted gas.
• Durable, compact design.
• Low maintenance.
1.2 Component Identification
Medical Air Flowmeter
Medical Air Flow Adjustment Valve
Medical Air Gas Inlet
Male DISS Fitting
22mm Male/15mm Female Conical
Outlet Fitting
Oxygen Flow Meter
Oxygen Gas Inlet
Oxygen Flow Adjustment Valve
IV Pole Clamp
Mixed Gas Analysis Port
Mixed Gas Analysis Port Cover
(Shown in open position)
1
2
3
4
5
6
7
8
9
10
11
3
8
2
4
5
10
11
1
6
7
9

866.4.Maxtec www.maxtec.com2
1.5 Operational Requirements
Pressurized Oxygen – For optimal performance the oxygen source must provide clean,
dry, medical grade oxygen at a line pressure of 50 ± 5 PSIG (345 ± 35 kPaG).
Pressurized Medical Air – For optimal performance the air source must provide clean,
dry, medical grade air at a line pressure of 50 ± 5 PSIG (345 ± 35 kPaG).
Note: Delivered gas characteristics are not affected by variations in input gas pressures.
2.0 OPERATING INSTRUCTIONS
2.1 Installation of MaxFLO2to an IV Pole
Note: Prior to placing the MaxFLO2into clinical use, the performance check described
in Section 3 of this operating manual should be completed.
1.3 Component Description
Oxygen Flowmeter - An acrylic flowmeter with a stainless steel float ball with black
lettering on a white background designed specifically for the flow of oxygen.
Medical Air Flowmeter - An acrylic flowmeter with a stainless steel float ball with
black lettering on a white background designed specifically for the flow of air.
Flow Control Valve - Valve controlling the flow of gas into the flowmeter.
Mixed Gas Outlet - A diameter indexed (DISS) oxygen fitting with a 22mm
male/15mm female conical fitting.
Oxygen Gas Inlet - Fitting for connection of an oxygen inlet hose from the oxygen
gas source.
Medical Air Gas Inlet - Fitting for connection of a medical air inlet hose from the
medical air gas source.
Mixed Gas Analysis Port - Integrated port designed to divert a gas sample to an
Analyzer/Monitor for intermittent or continuous gas sampling.
IV Pole Clamp - Clamp for securing the MaxFLO2to a vertical pole.
1.4 Symbol Guide
The following symbols and safety labels are found on the MaxFLO2.
LPM
Attention, consult accompanying
documents
Liter per minute flow
Read Float Ball On Center
Gas Inlet
Gas Outlet
Maximum allowable
temperature
!
Manufacturer
Warning Do Not
Latex Free
Maximum allowable pressure
Use no oil
SN Serial Number
REF Catalog Number
LATEX
EC REP Authorized representative in
the European Community
Federal law (USA) restricts this device
to sale by or on order of a physician
only

866.4.Maxtec www.maxtec.com 3
TO SET FiO2and FLOW:
1. Find correct total flow as
illustrated in Table 1.
2. Find closest FiO2
corresponding to correct
total flow as illustrated in
Table 1.
3. Set air flow as determined
by medical air LPM of
Table 1 by reading number
at top of medical air LPM
column.
4. Set oxygen flow as
determined by oxygen
LPM of Table 1 by reading
number at left of oxygen
LPM row.
See example on pg. 4 of this operating manual.
• Connect the 22mm Male/15mm Female conical outlet fitting to the male DISS fitting
on the bottom of the device as seen in section 1.2 of this operating manual.
• The rear of the MaxFLO2contains a pole clamp. Mount the unit securely to the pole
via the pole clamp. When mounting ensure the pole sits in the curved groove of the
clamp’s arm. Tighten the screw clockwise until the unit is completely secure.
• The MaxFLO2must be mounted in the vertical position for correct function of the air
and oxygen flowmeters.
• Connect a pressure capable air source to the air inlet fitting and a pressure capable
oxygen source to the oxygen inlet fitting.
• Connect the air and oxygen hoses to their respective gas sources.
• Connect appropriate tubing to the conical outlet fitting.
2.2 Setting Flow and Oxygen Concentration
• To increase the flow of air or oxygen turn the flow control knob of the desired gas
counter-clockwise. Each flowmeter contains a float ball which indicates the flow rate
when read against the flowmeter’s scale. The float ball must be read at centerline
while looking straight at the flowmeter.
• Table 1 (Oxygen Concentration) below, describes the required air/oxygen flow rates
required to attain a desired FiO2.
NOTE: For the Low Flow MaxFLO2, the maximum total flow at 21% O2or 100% O2is 10
LPM and the maximum total flow at 60% O2is 20 LPM.
Table 1
2
61
Total
Flow
FiO2
12345678910
8
10
9
4
6
5
7
2
1
3
Medical Air (LPM)
Oxygen Concentration
Oxygen (LPM)
3 4
4 5
65
6 7
8
7
7
8 9
5 6
6 7
7 8
8 9
7 8
8 9
109
10 11
9 10
12
10 11
11
12 13
9 10
10 11
11 12
11 12
12 13
1413
13 14
16
14 15
15
15 16
16 17
17 18
17 18
18 19
2019
11 12
12 13
13 14
14 15
13 14
14 15
1615
16 17
8 9
9 10
10 11
10 11
1211
12 13
23456
61 47
74 61
80 68
41 37
4753
61 55
41
34 32
44
51 47
84 74
87 77
89 80
90 82
66 61
70 65
6874
76 71
56 53
61
61 57
64
67 64
91 84
92 86
93 87
78 74
80 76
7782
70 66
70
72 68
74
63 61
65 63
67 65
58 56
61 58
6163
50 47
54 51
57 55
61 58
45 44
49 47
5153
56 54
31 30
39 37
45 43
29 28
3435
41 39
3
4
5
6
7
8
9
10
2
100
100
100
100
100
100
100
100
100
100
0
78910234561
1
021 21 21 21 21 21 21 21 21 21

866.4.Maxtec www.maxtec.com4
2.3 Use of Mixed Gas Analysis Port
The mixed gas analysis port on the MaxFLO2can be used to spot check or monitor
oxygen concentrations being delivered from the device. The mixed gas analysis port
contains a spring loaded valve which is opened on receipt of a standard 15mm flow
diverter connected to an analyzer/monitor. The mixed gas analysis port is designed to
support measurement of oxygen concentration without the need for continuous gas
bleed. The valve automatically closes when the diverter is removed.
Use caution to ensure the mixed gas analysis port is clean and free of any foreign matter
before each use. Always re-cover the port when the port is not in use with an oxygen
analyzer/monitor.
• Slide the mixed gas analysis port cover to the side to expose the port. Insert the
analyzer/monitor diverter completely into the port. A small gap may remain between
the bottom of the diverter and the top of the MaxFLO2, this is normal. Note: the mixed
gas analysis port contains a spring loaded valve. Diverters with improper fit may be pushed
out of the port by the force of the spring. Use the diverter supplied with the MaxFLO2.
• Follow the manufacturer’s recommended calibration procedures as outlined for your
particular analyzer/monitor.
All Maxtec analyzers/monitors are designed to be calibrated at 100% O2. Maxtec
recommends for accuracy, that during calibration, oxygen flow be set as close to the
desired total flow rate as possible. For example for a flow of 8 LPM of oxygen, and 4
LPM of air, calibrate using an oxygen flow of 10 LPM. Also, any downstream tubing
or cannula must be connected to the Mixed Gas Outlet in order to induce the same
amount of back pressure that will be seen during actual use.
3.0 PERFORMANCE CHECK
The MaxFLO2is designed for low maintenance operation. However, the following
functional tests should be performed periodically in order to ensure proper function.
• Install the MaxFLO2according to section 2.1 of this operating manual in order to
conduct the performance check.
12345678910
4
2
1
3
Medical Air (LPM)
Oxygen Concentration
LPM)
3 4
4 5
65
6 7
8
7
7
8 9
5 6 7 8 9 10 11 12 13 14
8 9
9 10
10 11
10 11
1211
12 13
23456
61 47
74 61
80 68
41 37
4753
61 55
41
34 32
44
51 47
84 74 66 61 56 53 50 47 45 44
31 30
39 37
45 43
29 28
3435
41 39
2
3
4
1
100
100
100
100
12345678910
21 21 21 21 21 21 21 21 21 21
0
0
Example:
Prescribed total flow rate is 8
LPM with an FiO2of 50%.
Start by locating total flow
rates in the 8’s, then search
among the 8 LPM flow rates
for the closest FiO2to 50%.
Then look up the column
for the air LPM setting and
look left down the row for the
oxygen LPM setting.
For 8 LPM flow at 50% FiO2set the air to 5 LPM and the oxygen to 3 LPM. Verify FiO2
with an analyzer/monitor prior to use.