Maxtec MaxBlend 2 User manual

MAXBlend™2
OPERATING MANUAL &
INSTRUCTIONS FOR USE
R229P01 / R229P02
LOW FLOW / HIGH FLOW
R229M01 Rev. B
60
50
40
30
21
70
80
90
100
%O2
%O2
AIR/O2

866.4.Maxtec www.maxtec.com I
Maxtec TEL [phone]
2305 South 1070 West FAX [phone]
Salt Lake City, Utah 84119 www.maxtec.com
USA
Authorized Representative:
Read this entire manual before attempting to operate or service the MAXBlend2. Attempting to
operate the MAXBlend2 without fully understanding its features and functions may result in unsafe
operating conditions.
CLASSIFICATION
Protection class:.......................................................II, Type B
Protection against water: ....................................................IPX1
Mode of operation:....................................................Continuous
Sterilization: ......................................................See section 6.0
Safety of application in the presence of a flammable anesthetic mixture:.........See section 9.4
Power specification: ................................7.5V(MAX) 1.9W/250mA(MAX)
CAUTION:Federal law restricts this device to sale by or on the order of a medical professional.
Product Disposal Instructions:
The sensor, batteries, and circuit board are not suitable for regular trash disposal. Return
sensor to Maxtec for proper disposal or dispose according to local guidelines. Follow local
guidelines for disposal of other components.
WARRANTY
The MAXBlend2 is designed for air/oxygen delivery. Under normal operating conditions, Maxtec
warrants the MAXBlend2 to be free from defects of workmanship or materials for a period of two years
from the date of receipt from Maxtec, provided that the unit is properly operated and maintained in
accordance with Maxtec’s operating instructions. Based on Maxtec’s 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.
Maxtec warrants the MAX-550E oxygen sensor in the MAXBlend2 to be free from defects in material
and workmanship for a period of two years from Maxtec's date of shipment in a MAXBlend2 unit.
Should a sensor fail prematurely, the replacement sensor is warranted for the remainder of the original
sensor warranty period. Routine maintenance items, such as batteries, 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, mis-application,
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.
EC REP QNET BV
Kantstraat 19
NL-5076 NP Haaren
The Netherlands
9700630
Conforms to AAMI STD ES60601-1, ISO STD 80601-2-55,
IEC STDS 60601-1-6, 60601-1-8 & 62366
Certified to CSA STD C22.2 No. 60601-1

866.4.Maxtec www.maxtec.comII
NOTE: In order to obtain optimum performance from your MAXBlend2, all operation and
maintenance must be performed in accordance with this manual. Please read the manual
thoroughly before using the MAXBlend2 and do not attempt any repair or procedure that is not
described herein. Maxtec cannot warranty any damage resulting from misuse, unauthorized repair
or improper maintenance of the instrument.
EMC Notice
This equipment generates, uses, and can radiate radio frequency energy. If not installed and used
in accordance with the instructions in this manual, electromagnetic interference may result. The
equipment has been tested and found to comply with the limits set forth in IEC 60601-1-2 for
medical products. These limits provide reasonable protection against electromagnetic interference
when operated in the intended use environments described in this manual.
MRI Notice
This equipment contains electronic and ferrous components whose operation can be affected
by intense electromagnetic fields. Do not operate the MAXBlend2 in an MRI environment or in
the vicinity of high-frequency surgical diathermy equipment, defibrillators, or shortwave therapy
equipment. Electromagnetic interference could disrupt the operation of the MAXBlend2.
WARNINGS
Indicates a potentially hazardous situation, if not avoided, could result in death or serious injury.
The following warnings apply any time you operate or service the MAXBlend2:
» Always confirm prescribed flow before administering to patient and monitor flow on a frequent basis.
» Always follow ANSI and CGA standards for medical gas products and flowmeters and oxygen handeling.
DO NOT operate the MAXBlend2 unless qualified personnel are in attendance to promptly
respond to alarms, inoperative conditions, or sudden malfunctions. Patients on life-support
equipment should be visually monitored at all times.
DO NOT ignore audible alarms of the MAXBlend2. Alarms indicate conditions that require your
immediate attention.
DO NOT use parts, accessories, or options that have not been authorized for use with the
MAXBlend2. Using unauthorized parts, accessories, or options may be harmful to the patient or
damage the MAXBlend2.
»Check all audible and visual alarms periodically to ensure they are operating properly. If an alarm
fails to activate, contact your Maxtec Certified Service Technician.
DO NOT operate the MAXBlend2 with the monitor powered off or without setting the adjustable
alarms. All adjustable alarms must be set to ensure safe operation.
DO NOT steam autoclave or otherwise subject the MAXBlend2 to temperatures above 122°F (50°C).
»If the air or oxygen gas source fails, the pressure differential alarm will sound alerting the
clinician that a condition has occurred that may significantly alter the FiO2and flow output from
the MAXBlend2.
»If either the air or oxygen source pressure is reduced or increased sufficiently to create a
pressure differential of 20 PSI or more, an audible alarm will sound. This condition may
significantly alter the FiO2and flow output from the MAXBlend2.
DO NOT use humidified oxygen to calibrate this system. If calibrated with humidified oxygen,
subsequent oxygen readings will be higher than the true oxygen level.
DO NOT tape, obstruct or remove the alarm during clinical use.
DO NOT occlude the sensor port on the side of the MAXBlend2.
» An air inlet/water filter is recommended for use with the MAXBlend2. See section 6.1.
» If the MAXBlend2 does not function as described in section 2, contact your maxtec distributor or
Maxtec Certified Service Technician.
DO NOT use lubricants on the MAXBlend2.
!

866.4.Maxtec www.maxtec.com III
DO NOT use the MAXBlend2 until correct performance has been verified. See section 3.0.
»If a condition is detected that could possibly prevent the monitor from continuing to operate
safely, it will sound an alarm. If at any time, EOx (i.e. EO2, EO4, etc.) appears on the LCD,
refer to section 4.0 or contact a Maxtec Certified Service Technician.
»All service should be referred to a Maxtec Certified Service Technician.
»Elastomer components such as O-rings are designed to function satisfactorily for a minimum of
two years. Maxtec recommends that the MAXBlend2 be serviced by Maxtec at a minimum of
every two years or if a leak or other performance problem is suspected.
»If the MAXBlend2 is dropped, follow the procedures outlined in section 3.0 for a performance
check before reusing the device.
»Always remove the batteries to protect the unit from potential leaky battery damage when the
unit is going to be stored (not in use for more than 30 days).
»Always replace batteries with recognized name brand AA alkaline batteries.
» The MAXBlend2 has the ability to set the low oxygen alarm below 18% and can be set as low as
15% (see section 2.3 on setting alarms). This is in accordance with IEC 80601-2-55.
To prevent risk of burns, fire or injury to person(s):
»The mixed gas bleed continuously bleeds to atmosphere at the oxygen concentration setting
of the control knob. Bleeding oxygen into any closed area could increase the risk of fire or
explosion. DO NOT operate this device in the presence of any flame or source of ignition; or
when using equipment such electrosurgical equipment or defibrillators.
»To avoid explosion, DO NOT operate the MAXBlend2 in the presence of flammable anesthetics
or in an atmosphere of explosive gases. Operating the MAXBlend2 in flammable or explosive
atmospheres may result in fire or explosion.
»Galvanic O2sensor electrolyte gel is acidic and may cause skin or eye irritation and/or burns.
Take care when handling or replacing exhausted or damaged disposable O2sensors. Be sure to
dispose of expired sensors in accordance with hospital and/or governmental regulations (O2Sensor
SDS upon request from Maxtec).
DO NOT use or store oils, greases, organic lubricants or any combustible materials on or near
this device.
CAUTION: Indicates a potentially hazardous situation, if not avoided, could result in minor or
moderate injury and property damage.
DO NOT store the MAXBlend2 in hot areas for prolonged periods of time. Temperatures above 80°F
(27°C) can shorten battery life.
»To minimize the potential for electrostatic shock, do not use antistatic or electrically conductive
hoses with the MAXBlend2.
DO NOT clean or dry the MAXBlend2 with a high pressure air gun. Applying high pressure air to
the MAXBlend2 may damage components and render the system inoperable.
DO NOT over clean the MAXBlend2. Repeated use of a cleaning agent can cause residue buildup
on critical components. Excessive residue buildup can affect the MAXBlend2's performance.
»When cleaning the MAXBlend2: DO NOT use harsh abrasives. DO NOT immerse the
MAXBlend2 in liquid sterilizing agents or liquids of any kind. DO NOT spray cleaning solution
directly onto the sensor port, bleed muffler or buzzer opening. DO NOT allow cleaning solution
to pool on the front panel,sensor port or bleed muffler.
DO NOT sterilize the MAXBlend2. Standard sterilization techniques may damage the blender.
DO NOT smoke in an area where oxygen is being used.
»If the MAXBlend2 does not function as outlined in section 2.0, contact a Maxtec trained service
technician or Maxtec for service.
DO NOT attempt to clean the MAXBlend2 using agents or methods other than those specified in
the cleaning section of this document.
»Dropping or severely jarring the sensor after calibration may shift the calibration point enough to
require recalibration.

866.4.Maxtec www.maxtec.comIV
»Always operate the MAXBlend2 with clean, dry medical grade gases. Contaminants or moisture
can cause defective operation. Oxygen should have a minimum dewpoint of -80°F (-62°C) or
moisture content less than 7.9 PPM (0.0059mg/L). Oxygen “purity” should be at least 99.0%
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 G-4.3 and G7.1 for more
information. Water vapor content of medical air or O2 supply to the blender must not exceed
5.63 x 103milligrams H2O per cubic meter of non-condensible gas.
DO NOT disassemble the MAXBlend2. All service should be performed by a Maxtec Certified
Service Technician.
DO NOT use humidified oxygen to calibrate this system.
»Be sure the MAXBlend2 is securely mounted. This device is usually mounted to a hospital rail
system or an infusion stand. Dropping the device may cause injury or device damage.
» The oxygen sensors contain a weak acidic solution encapsulated in a plastic housing. Under
normal operating conditions the solution (electrolyte) is never exposed.
DO NOT use the oxygen sensor if it appears to be damaged or is leaking.
NOTES: Indicates supplemental information to assist in use of the device.
»The MAXBlend2 is tested for compliance with ISO 11195, and meets requirements regarding
reverse gas flow as delivered.
»Applicable parts used in the MAXBlend2 have been cleaned and degreased for oxygen service. Any
lubricants used are designed specifically for the application.
»As long as the absolute pressure of the gas mixture being monitored is constant, the MAXBlend2
will accurately read oxygen concentrations. However, if the absolute pressure varies the reading
will fluctuate proportionately as the sensor actually measures the partial pressure of oxygen
in the mixture. The sensor readings will also change proportionately with barometric pressure
changes. Because of this, daily calibration of the sensor is recommended.
»Users are advised to use pressure regulators which display the outlet pressure.
»All specifications assume the following standard environmental conditions, unless specified otherwise.
Ambient and sample gas temperatures of 77°F (25°C); barometric pressure of 30inHg (760mmHg);
sea level altitude; ambient relative humidity of 50%; sample gas relative humidity of 0%.
»It is important to note that the oxygen concentration selection scale is provided only as a
guideline for selecting O2concentrations. The clinician should use the MAXBlend2’s display
panel to adjust the O2concentration to the desired setting.
»The alarm limits can be set to levels that would render them useless for a particular patient's
clinical condition. Ensure that the delivered oxygen level and flow rate are set to values prescribed
by the patient's physician. Also ensure that the high and low alarm limits are set to levels such
that they will sound if the oxygen level is outside of safe limits. Be sure to review and, if necessary,
re-set the alarm limits when the patient's clinical condition changes or when the patient's
physician prescribes a change in oxygen therapy.
»This device does not contain automatic barometric pressure compensation.
»Gas leaks that cause room air to mix with the gas sample may cause inaccurate oxygen
readings. Ensure the O-rings on the sensor and flow diverter are in place and intact prior to use.

866.4.Maxtec www.maxtec.com V
TABLE OF CONTENTS
CLASSIFICATION ...................................................I
WARRANTY .......................................................I
WARNINGS ...................................................... II
1.0 INTRODUCTION ............................................... 1
1.1 Indication for Use ...................................................... 1
1.2 Max-550E Oxygen Sensor ................................................ 1
1.3 Symbol Guide ......................................................... 2
1.4 Component Identification ................................................. 3
1.5 Back View ............................................................ 5
1.6 What You Will Need to Operate the Blender ................................... 6
2.0 OPERATING PROCEDURES ....................................... 6
2.1 Setup and Installation ................................................... 6
2.1.1 Battery Installation .................................................... 6
2.1.2 MAXBlend2 Setup .................................................... 7
2.1.3 Sensor Installation..................................................... 7
2.2 Monitoring ............................................................ 7
2.3 Alarm Setting Procedure ................................................. 7
2.3.1 Low Alarm Setting ..................................................... 7
2.3.2 High Alarm Setting .................................................... 8
2.3.3 Smart Alarm Mode .................................................... 8
2.4 Basic Operation ........................................................ 9
2.5 Alarm Conditions and Priorities ............................................ 9
2.6 Backlight Operations ................................................... 10
2.7 External Power Supply Operation .......................................... 10
2.8 Calibration Procedures.................................................. 10
2.8.1 Calibration to 100% Oxygen ............................................ 10
2.8.2 Calibration to Room Air ................................................ 11
3.0 PERFORMANCE CHECK ......................................... 11
3.1 Blender Safety Check................................................... 12
4.0 TROUBLESHOOTING ........................................... 12
4.1 Problem Troubleshooting ................................................ 12
5.0 CLEANING AND DISINFECTING THE MAXBLEND2 ..................... 15
6.0 SERVICE AND MAINTENANCE .................................... 16
6.1 Maintenance ......................................................... 16
6.2 Replacing the O2Sensor ................................................ 16
6.3 Alarm Testing......................................................... 16
7.0 ABBREVIATION GUIDE ......................................... 17
8.0 SPECIFICATIONS.............................................. 17
8.1 Low Flow Instrument Specifications ........................................ 17
8.2 Alarm Specifications ................................................... 17
8.3 O2Sensor Specifications ................................................ 18
9.0 FACTORS INFLUENCING CALIBRATION ............................. 18
9.1 Temperature Effect..................................................... 18
9.2 Pressure Effect ....................................................... 18
9.3 Humidity Effect ....................................................... 19
9.4 Exposure to Anesthetic Gases ............................................ 19
10.0 SPARE PARTS AND ACCESSORIES ................................ 20
11.0 THEORY OF OPERATION ....................................... 21
11.1 Operational Diagram .................................................. 21
11.2 Mixing Operation ..................................................... 21
11.3 Gas Outlet .......................................................... 22
11.4 Alarm/Bypass Function ................................................ 22
12.0 FLOW CHARACTERISTICS ...................................... 23
13.0 ELECTROMAGNETIC COMPATIBILITY .............................. 24

866.4.Maxtec www.maxtec.com 1
1.0 INTRODUCTION
The MAXBlend2 is a compact air/oxygen gas mixing device which incorporates
the use of a battery powered oxygen monitor. The gas mixing device (blender)
provides precise mixing of medical grade air and oxygen, while the monitor
measures the selected oxygen concentrations from the blender’s gas flow
and displays these measured concentrations on a digital display. The monitor
provides high and low alarm limits which, when exceeded, cause an audible
and visual alarm.
1.1 Indication for Use
The MAXBlend2 is designed to provide a continuous air/oxygen gas mixture to
infant, pediatric, and adult patients. It is a restricted medical device intended
for use by qualified, trained personnel, under the direction of a physician, in
institutional environments where the delivery and monitoring of air/oxygen
mixtures is required.
1.2 MAX-550E Oxygen Sensor
The MAX-550E is a galvanic, partial pressure sensor that is specific to oxygen.
It consists of two electrodes (a cathode and an anode), a teflon membrane
and an electrolyte. Oxygen diffuses through the teflon membrane and
immediately reacts electrochemically at a gold cathode. Concurrently, oxidation
occurs electrochemically at a lead anode, generating an electrical current
and providing a voltage output. Electrodes are immersed in a unique gelled
weak acid electrolyte which is responsible for the sensors long life and motion
insensitive characteristic. Since the sensor is specific to oxygen, the current
generated is proportional to the amount of oxygen present in the sample gas.
When no oxygen is present, there is no electrochemical reaction and therefore,
negligible current is produced. In this sense, the sensor is self-zeroing.
CAUTION: The MAX-550E oxygen sensor is a sealed device containing a mild acid
electrolyte and lead (Pb). These materials are hazardous waste constituents and should
be disposed of properly, or returned to Maxtec for proper disposal or recovery.
CAUTION: Dropping or severely jarring the sensor after calibration may shift the
calibration point enough to require re-calibration.

866.4.Maxtec www.maxtec.com2
1.3 Symbol Guide
The following symbols and safety labels are found on the MAXBlend2:
SYMBOL GUIDE
The following symbols and safety labels are found on the MAXBlend2 and/or labeling:
POWER SUPPLY SYMBOL GUIDE
The following symbols and safety labels are found on the MAXBlend2 power supply:
EC REP Authorized Representative
in the European Community
IPX2 Ingress Protection
Rating
LPM Liters Per
Minute
REF Catalog Number
Manufacturer
Attention, consult accompanying
documents
Two means of patient
protection (double insulated)
Power Supply Meets CEC Tier
3 and EU Phase 2 Standards
Consult Instructions For Use
Complies with Directive 2011/65/EU
RoHS
Calibration Reminder
Do Not Corrosive
Warning
!
DOWN (LOW ALARM) Key UP (HIGH ALARM) Key
ON/OFF Key Silent Key
Smart Alarm Key
Backlight Key
High Alarm Indicator Low Alarm Indicator
Alarm Silence
Indicator
Sleep Mode Indicator
Smart Alarm Mode
Indicator
Low Battery
Indicator
BAT
CAL (Calibration Key)
CAL
Unlock Key
Type B Applied
Parts
Direct
Current
Meets ETL
standards
9700630
122˚F
50˚C
5˚F
-15˚C
Storage Temperature Range
122˚F
50˚C
5˚F
-15˚C
Do not throw away. Follow local
guidelines for disposal.
Do not throw away. Follow local
guidelines for disposal.
Conforms to EU requirements
For use in dry indoor locations
Federal law (USA) restricts this device
to sale by or on order of a physician
only
Combined UL / CSA Mark
InletOutlet
AIR/O2Oxygen Encriched Air
SN Serial Number
Use No Oil
%02Oxygen
Percent
Read Flow At Center Of Ball
Below 18%
Alarm Indicator

866.4.Maxtec www.maxtec.com 3
1.4 Component Identification
<18% Alarm Indicator - The <18% alarm indicator is located above the
Low Alarm Indicator digits. When the low alarm setting is set below <18%, the
indicator will flash each second to alert the operator of this special condition.
See section 2.3.1 for setting this low alarm condition.
Low Alarm LED - In a low alarm condition, the red "LOW ALARM" LED will
flash twice a second, accompanied by the audio buzzer.
High Alarm LED - In a high alarm condition, the red "HIGH ALARM" LED
will flash twice a second accompanied by the audio buzzer.
3 1/2-Digit Display - The 3 1/2 digit liquid crystal display (LCD) provides
direct readout of oxygen concentrations. The digits also display error codes,
alarm set modes and calibration codes as necessary.
% Symbol - The "%" sign is located to the right of the concentration number
and is present during normal operation.
Alarm Silence/Smart Alarm Indicator - When the Silent key is pressed the
indicator will display with cross bars to alert condition. When Smart Alarm
key is pressed the indicator will display with T-bars to alert condition.
60
50
40
30
21
70
80
90
100
%O2
%O2
AIR/O2
3
2
4
110
24
22
19
25
18
23 26
5
6
7
9
8
11
15
13
16
20 12
21
6
5
4
3
2
1
14
17
Consult Instructions For Use
Do not throw away. Follow local
guidelines for disposal.
Conforms to EU requirements
Combined UL / CSA Mark

866.4.Maxtec www.maxtec.com4
Low Battery Indicator - BAT The low battery indicator is located at the
middle of the display and is only activated when the voltage on the batteries
is below a normal operating level.
High Alarm Indicator - The high alarm setting is displayed at all times just
below the "HIGH" icon on the LCD readout. The indicated value represents the
oxygen percentage at which the high alarm will be activated.
Calibration Reminder - The calibration reminder symbol is located at the
bottom of the display. This symbol will be lighted after one week has elapsed
from the previous calibration.
Low Alarm Indicator - The low alarm setting is displayed at all times just
below the "LOW" icon on the LCD readout. The indicated value represents
the oxygen percentage at which the low alarm will be activated.
Up (Alarm High) Key - The up key is used in setting the high FiO2alarm
limit. The device must be in the unlocked state for the key to operate. See
section 2.3.2 for instructions on setting the high FiO2alarm limit.
Silent Key - In an alarm condition, pressing the SILENT key will deactivate
the audio alarm for 2 minutes.
ON/OFF Key - This key is used to turn the device on or off. To turn the
device OFF, the button must be held while a rapid 3-2-1 countdown takes
place to prevent accidental power-off.
Calibration Key - This key is used to calibrate the device. The device
must be in the un-locked state for the key to operate. See section 2.8 for
instructions on calibrating.
Down (Alarm Low) Key - The down key is used in setting the low FiO2
alarm limit. The device must be in the unlocked state for the key to operate.
See section 2.3.1 for instructions on setting the low FiO2alarm limit.
Un-lock Key - The un-lock key is used to unlock and lock the instrument.
Sleep Mode Indicator -The sleep mode indicator is used to help with
battery consumption.
Flow Control Knob - The flow control knob controls the flow of gas exiting
the flowmeter.
Oxygen Flowmeter - Measures the flow of mixed gas exiting the flowmeter outlet.
Backlight Key - The backlight key will manually activate the backlight for 30
seconds. See section 2.6 for more information on backlighting operation.
Smart Alarm Key - The Smart Alarm key is used to help set the High-Low Alarm
window quickly. See section 2.3.3 for instructions on using the Smart Alarm setting.
Bleed Toggle Switch - Turns on the auxiliary bleed. The bleed must be
turned on whenever the total flow delivered to the patient is less than 15
LPM for high flow model, or less than 3 LPM for low flow model.
CAL
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22

866.4.Maxtec www.maxtec.com 5
Medical Air Inlet Connector - An air fitting for connection to an air inlet hose
from the air gas source.
Flowmeter Outlet - A fitting for connection to the patient delivery tubing.
Oxygen Concentration Selector Control - A knob which allows for selections
of mixed oxygen concentrations from 21% to 100%.
O2Inlet Fitting - An O2fitting for connection to the O2inlet hose from the
gas source.
1.5 Back View
Mount Adapter - An adapter which allows the MAXBlend2 to be mounted
onto a mating bracket for mounting to a rail or ventilator system.
O2Sensor Port - A sampling port for the oxygen sensor. It allows
mixed gas from the blender to flow over the sensor membrane.
Pressure Differential Reed Alarm - An audible alarm which, when activated,
indicates that an unacceptable pressure differential exists between the two gas
source pressures.
Sensor with Diverter - The sensor with flow diverter is designed to fit into a
port behind the flow meter.
Sensor Cable - The cable connects the MAXBlend2,to the MAX-550E Sensor.
External Power Supply Port - The port provides connection for the external
power adapter. See section 2.7 for more information on the power supply.
Auxiliary Mixed Gas Outlet - Can be used to add additional flowmeters.
Auxiliary Mixed Gas Outlet - Can be used as power take off.
Battery Compartment - powered by four, AA, alkaline batteries.
B
E
D
C
F
I
A
G
H
23
24
25
26
F
G
H
I
E
D
C
B
A

866.4.Maxtec www.maxtec.com6
1.6 What You Will Need to Operate the Blender
All operator-detachable inlet pressure hoses supplied with the gas mixer comply
with ASTM/ISO 5359.
Pressurized Oxygen: The compressed oxygen source must provide clean, dry,
medical grade oxygen at the pressure specified in Section 8.0.
Pressurized Air: The compressed air source must provide clean, dry, medical
grade air at the pressure specified in Section 8.0.
2.0 OPERATING PROCEDURES
2.1 Setup and Installation
2.1.1 Battery Installation
All MAXBlend2 units are powered by four, AA, alkaline batteries (4 x 1.5 Volts)
and are shipped without the batteries installed. The battery compartment
is accessible from the back side of the unit. Batteries should be changed
by service personnel. Use only brand name batteries. Replace with four AA
batteries and insert per orientation marked inside the battery box.
To install the batteries:
Open the battery drawer by squeezing inward on both tabs as shown in figure
below. If you have difficulty squeezing the tabs in with your fingers, use two
flat screwdrivers or two coins. Remove the battery drawer completely from the
MaxBlend2. Install four new, AA, alkaline batteries in the unit, observing the
orientation shown on the plastic inside the drawer. Slide the drawer back in
with the batteries facing upward. Press in on the drawer until both tabs latch
into place.
WARNING: Battery replacement by inadequately trained personnel could result in a
safety hazard.
WARNING: Electrical shock or damage to the equipment may occur if an
inappropriate external power supply is used. Maxtec recommends using only the
Maxtec MAXBlend2 External Power Supply - R230P10.
!
!

866.4.Maxtec www.maxtec.com 7
2.1.2 MAXBlend2 Setup
1.Connect the pressurized air source to the air inlet fitting (see page 3 for location).
2. Connect the pressurized oxygen source to the oxygen fitting (see page 3 for location).
3. Flush gas at the highest possible flow rate through the blender for at least one minute
to eliminate any particulate that may have been introduced into the system during
handling and installation.
2.1.3 Sensor Installation
1.Plug the sensor cable into the cable port on the sensor. Thread and tighten
the locking shroud to lock the cable in place.
2.Press the ON/OFF key . Insert the sensor into the sensor port on the left
side of the MAXBlend2 behind the flowmeter.
3.Allow adequate time for the sensor to equilibrate to ambient temperature.
4.Follow the desired calibration procedure in section 2.8.
2.2 Monitoring
Before use on a patient, the oxygen concentration of the delivered gas should
be checked at the setting intended for use.
To begin monitoring, press the ON/OFF key located on the front panel
(if necessary). Monitoring will begin immediately.
Should oxygen level exceed either the HIGH or LOW alarm set points, the red
alarm indicator on the front panel will illuminate indicating either a high or low
oxygen condition within limits or the limits are adjusted.
To conclude monitoring, press the ON/OFF key located on the front panel.
This will place the MAXBlend2 in a standby mode in which the display
and alarm circuits are not functional, but the gas blender supply hoses will
continue to supply mixed gas if the inlet hoses have not been disconnected.
2.3 Alarm Setting Procedure
2.3.1 Low Alarm Setting
To adjust the low alarm setting:
1.Press the Un-lock key to unlock the keypad. Note the LOW, Smart Alarm,
CAL and HIGH icons will begin to flash indicating the SET OPERATING MODE.
2.Press the DOWN (LOW ALARM) key on the keypad.
NOTE: the Low Alarm digits begin to flash indicating the Low Alarm manual setting.
3. Use the UP and DOWN keys to set the low alarm to the desired value.
Pressing the arrow keys changes the value in 1% increments. If the keys are held
down for more than 1 second the display will scroll at a rate of 1% per second.
NOTE: If 30 seconds elapse between key actuations, the system will store the latest
high alarm setting and will revert to normal operation. If this occurs inadvertently,
simply repeat the alarm setting procedure.

866.4.Maxtec www.maxtec.com8
There is a special condition that allows the low oxygen alarm to be set below
18%. To access this condition press the DOWN arrow key for three seconds
while the low alarm reading displays 18%. The alarm setting can now be
adjusted to 17, 16, or 15%. A bar will blink above the setting to provide further
indication that the alarm has been set to this special <18% condition.
The low alarm value cannot be set lower than 15%, nor can it be set closer
than 1% from the high alarm value. For example, if the high alarm is set at
25%, the system will not accept a low alarm setting greater than 24%.
4.When the low alarm value is set, press the Un-lock key to accept the low
alarm setting and return to normal operation.
NOTE: The default low alarm setting is 18% O2. Removing the batteries or shutting the
unit OFF will reset the low alarm limit to 18% if it is set to <18%.
2.3.2 High Alarm Setting
To adjust the high alarm setting:
1.Press the Un-lock key to unlock the keypad. Note the LOW, SMART ALARM,
CAL and HIGH icons will begin to flash indicating the SET OPERATING MODE.
2.Press the UP (HIGH ALARM) key on the key pad.
NOTE: The High Alarm digits begin to flash indicating the High Alarm manual setting.
3. Use the UP and DOWN keys to set the high alarm to the desired value.
Pressing the arrow keys changes the value in 1% increments. If the keys are held
down for more than 1 second the display will scroll at a rate of 1% per second.
NOTE: If 30 seconds elapse between key actuations, the system will store the latest
high alarm setting and will revert to normal operation. If this occurs inadvertently,
simply repeat the alarm setting procedure.
When the high alarm setting is set above 100% the high alarm will indicate two
dashes - -. This special condition turns off or deactivates the high alarm.
4.When the high alarm value is set, press the Un-lock key again to accept
the high alarm setting and return to normal operation.
NOTE: The default high alarm setting is 50% O2. Removing the batteries will reset the
high alarm limit to 50%.
2.3.3 Smart Alarm Mode
1.Press the Un-lock key to Un-lock the keypad. Note the LOW, Smart Alarm,
CAL and HIGH icons will begin to flash indicating the SET OPERATING MODE.
2.Press the Smart Alarm key on the keypad. Note the LOW digits, Alarm Mode
and HIGH digits begin a slow flash indicating SMART ALARM MODE. The high
alarm will now be set equal to the current oxygen reading +3% (rounded to
the nearest integer). The low alarm will now be set equal to the current oxygen
reading -3% (rounded to the nearest integer but never lower than 18%).

866.4.Maxtec www.maxtec.com 9
3.Pressing of the Up key will add one to the high alarm setting and subtract one
from the low alarm setting. Pressing the Down key will subtract one from the
high alarm setting and add one to the low alarm setting. In other words, the
Up Arrow widens the alarm band and the Down Arrow tightens the alarm
band. This feature will not set the alarm levels above 100% or below 18%.
4.Once the desired alarm settings are attained, press the Un-lock key to
save the settings and return to normal operation mode. If 30 seconds elapse
without a key press by the user, the device will automatically save the new
alarm settings and return to normal operation mode.
2.4 Basic Operation
To check the oxygen concentration of the delivered gas:
1.Ensure the sensor is connected to the flow diverter and inserted completely
in the sensor port behind the flow meter.
2.Set the oxygen blender control knob to the desired oxygen setting.
3.Using the ON/OFF key , make sure the unit is in the power on mode.
4.Allow the oxygen reading to stabilize.
5.Adjust the flow meter to the desired flow rate. Read the flow rate at the
center of the float ball.
CAUTION: The outlets of this device are capable of delivering pressure as high as the
inlet pressure. Ensure that the devices that carry the gas from the blender to the patient
prevent excessive pressure to the patient.
2.5 Alarm Conditions and Priorities
In the event of either a low alarm or high alarm condition, the corresponding
LED will begin to flash, accompanied by the audio buzzer. Pressing the SILENT
key will deactivate the buzzer but the LED and the alarm value digits on the
display will continue to flash until the alarm condition has been rectified. If the
Alarm Alarm Priority
Low Alarm
LED
(add symbol)
High Alarm
LED
(add symbol)
Audible Alarm Audible Alarm
Repeat
Line Power Plugged In
Line Power Unplugged
External DC Power Supply
voltage out of range
Battery Voltage too low for
device to operate (E04)
Oxygen level above the high
oxygen alarm setting
Oxygen level below the low
oxygen alarm setting
Oxygen level below the low
oxygen alarm setting and
lower than 18%
Informational
Informational
Informational
Medium
Medium
Medium
High
Off Off
Single Yellow
Pulse
Single Yellow
Pulse
Solid Yellow Solid Yellow
Pulsing Yellow Pulsing Yellow
Pulsing Yellow
Off
Off
Off
Pulsing Yellow
Pulsing Red
2 Pulses
2 Pulses
2 Pulses
3 Pulses
3 Pulses
3 Pulses
5+5 Pulses
No Repeat
No Repeat
Every 15 Sec.
Every 15 Sec.
Every 25 Sec.
Every 25 Sec.
Every 25 Sec.

866.4.Maxtec www.maxtec.com10
alarm condition still exists 120 seconds after silencing the audio buzzer, the
beeper will start to sound again.
A low alarm condition will remain until the actual concentration is 0.1% higher
than the low alarm setting. A high alarm condition will remain until the actual
concentration is 0.1% lower than the high alarm setting.
To help differentiate the level of severity, the Monitor provides three unique
sound bursts.
2.6 Backlight Operation
To turn on the backlighting:
1. When the unit is on, pressing the Backlight button will turn the backlighting
on for 30 seconds. Additional presses will turn off the backlighting.
2. If the device is being used in a dark location, any button press will activate
the backlight.
CAUTION: Excessive use of the back light can reduce the life of the batteries.
2.7 External Power Supply Operation
To extend the life of the batteries an external Maxtec approved 7.5V DC
external power supply can be purchased. Once connected to the unit, total
power is supplied by the power supply. The batteries are still required to be in
the unit and will provide emergency power in the event main AC power is lost.
NOTE: Use only the Maxtec external power supply called out in section 10.0.
NOTE: The power supply is not a battery charger. DO NOT use rechargeable batteries.
2.8 Calibration Procedures
2.8.1 Calibration to 100% Oxygen
The MAXBlend2 should be calibrated before being placed into clinical use.
Thereafter, Maxtec recommends calibration of the unit on a weekly basis. Frequent
calibration will have no adverse effect on the performance of the MAXBlend2.
Calibration should also be performed upon replacement of a sensor.
The sensor is best calibrated while mounted in the MAXBlend2 sensor port.
As in normal operation, the oxygen sensor responds best when installed in a
vertical position with the sensor facing down.
Changes in barometric pressure can affect the oxygen reading.
A 1% change in the barometric pressure results in an error of 1% of actual
reading (Example: If you are reading a 50% oxygen mix and the barometric
pressure drops from 1000mbar to 990mbar the reading will drop to 50%
x (990/1000) = 49.5%). Maxtec recommends that you re-calibrate after
changing point-of-use elevation by more than 500 feet (150m).
It is best to calibrate the MAXBlend2 using the sensor port, and with a
technical grade oxygen standard (99.0% or better). Calibration of the unit with
room air is less accurate over the full FiO2operating range.

866.4.Maxtec www.maxtec.com 11
1.Connect the oxygen supply line (Pressure differential alarm may sound).
Verify the sensor is plugged into the O2sensor port and connected to the
sensor cable. DO NOT connect air supply line at this time.
2. Using the ON/OFF key , make sure the MAXBlend2 is in the power on mode.
3.Rotate the FiO2control knob to the 100% stop. Allow a few minutes for the
reading to stabilize.
4.Press the Un-lock key to unlock the keypad. Note the LOW, Smart Alarm,
CAL and HIGH icons will begin to flash indicating the SET OPERATING MODE.
5.Press the CALIBRATION key on the keypad. The word "CAL" will appear
on the display for approximately 5 second and then finish with 100.0%.
6.The unit is now calibrated and in the normal operating mode.
2.8.2 Calibration to Room Air
The MAXBlend2 can quickly be calibrated to room air (20.9%)
To use this function:
1.Connect the air supply line (Pressure differential alarm may sound). Verify
the sensor is plugged into the O2sensor port and connected to the sensor
cable. DO NOT connect oxygen supply line at this time.
2.Using the ON/OFF key , make sure the MAXBlend2 is in the power on mode.
3. Rotate the FiO2control knob to the 21% stop. Allow a few minutes for the
reading to stabilize.
4.Press the Un-lock key to unlock the keypad. Note the LOW, SMART ALARM,
CAL and HIGH icons will begin to flash indicating the SET OPERATING MODE.
5.Press the CALIBRATION key on the keypad. The word "CAL" will appear on
the display for approximately 5 seconds and then finish with 20.9%.
6.The unit is now calibrated and in the normal operating mode.
3.0 PERFORMANCE CHECK
Prior to placing the MAXBlend2 into clinical use, perform the following tests.
WARNING: If the MAXBlend2 does not function as described on the next
page, contact your Maxtec Distributor or contact a Maxtec Certified Service
Technician at:
Maxtec
2305 South 1070 West
Salt Lake City, UT 84119
[phone] or [phone]
DO NOT use the MAXBlend2 until correct performance has been verified.
CAL
CAL
!

866.4.Maxtec www.maxtec.com12
3.1 Blender Safety Check
NOTE: Before proceeding, ensure that the high alarm set point control is OFF [display
reads (--)] and that the low alarm set point control is below 20%.
PROCEDURE MAXBlend2 RESPONSE
1. Adjust the oxygen concentration such
that the display reads 60% O2±3%.
No response.
2. Disconnect the 50 PSIG AIR source
from the MAXBlend2.
Audible alarm sounds. Display reads
100% +/-3%.
3. Reconnect 50 PSIG AIR source to the
MAXBlend2.
Audible Alarm stops. Verify that
display panel reads 60% ±5%.
4. Disconnect 50 PSIG OXYGEN source
from the MAXBlend2.
Audible alarm sounds. Display reads
20.9% +/-3%.
5. Reconnect 50 PSIG OXYGEN to the
MAXBlend2.
Audible alarm stops. Verify that
display panel reads 60% ±5%.
6. Adjust both air and oxygen inlet
regulators to 0 PSIG.
No response.
7. Remove air inlet hose at regulator and
insert end into beaker of water.
No response.
8. Slowly raise pressure of oxygen
regulator to 50 PSIG and back to 0 PSIG
while observing air hose end in beaker.
No bubbles should be observed.
Audible alarm sounds.
9. Dry and reattach air inlet hose to regulator. No response.
10. Remove oxygen inlet hose at regulator,
and insert end into beaker of water.
No response.
11. Slowly raise pressure of air regulator
to 50 PSIG and back to 0 PSIG while
observing oxygen hose end in beaker.
No bubbles should be observed.
Audible alarm sounds.
12. Dry and reattach oxygen inlet hose to
regulator.
No response.
4.0 TROUBLESHOOTING
4.1 Problem Troubleshooting
Problem: Oxygen concentration discrepancy between oxygen concentration
selection knob and actual reading on display.
Potential Causes and Solutions:
»Monitor out of calibration. Calibrate. Refer to section 2.8, Calibration Procedure.
»Sensor exhausted. Replace sensor. Refer to section 6.2.
»Gas supply contaminated. Contact Maxtec for repair of the MAXBlend2.
»MAXBlend2 blender out of calibration. Contact Maxtec for repair.