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WARRANTY THE MAXBlendTM IS WARRANTED TO BE FREE FROM DEFECTS IN MATERIAL AND WORKMANSHIP AND TO MEET THE PUBLISHED SPECIFICATIONS FOR TWO (2) YEARS .

Warranty Statement: Maxtec®, Inc. oxygen sensors are designed for medical oxygen delivery equipment and systems. Under normal operating conditions Maxtec® warrants new oxygen sensors to be free from defects of workmanship and materials for their designated warranty period of one (1) years from date of shipment from Maxtec, provided that the sensor is properly installed and operated.

Maxtec®’s sole obligation under this warranty is limited to making sensor replacements or issuing credit for sensors found to be defective by Maxtec®. This warranty extends only to the buyer purchasing the sensor directly from Maxtec® or through Maxtec®’s designated distributors and agents as new equipment. Should a sensor fail prematurely, the replacement sensor is warranted for the remainder of the original sensor warranty period. Maxtec®, Inc. and any other subsidiaries or affiliates shall not be liable to the buyer or other persons for incidental, consequential damages or sensors 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.

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EQUIPMENT SYMBOLS WARRANTY The MAXBlendTM monitor is designed for medical oxygen delivery equipment and systems. Under normal operating conditions, Maxtec® warrants the MAXBlendTM monitor to be free from defects of workmanship or materials for a period of two (2) years from the date of shipment from Maxtec®, provided that the unit is properly operated and maintained in accordance with Maxtec®, Inc.’s operating instructions. Maxtec®’s sole obligation under this warranty is to repair, replace, or issue 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, such as batteries, are excluded from warranty. Maxtec®, Inc., and any other subsidiaries or affiliates shall not be liable to the buyer or other persons for incidental, consequential damages or sensors 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.

The following symbols appear on the MAXBlend™. Symbol

!

Compliance

Meaning

IEC 878

This symbol indicates ATTEN-

Symbol #03-

TION, consult the ACCOMPANY-

02

ING

DOCUMENTS.

IEC 417

This symbol indicates a FUSE.

Symbol #5016 This symbol indicates an input.

IEC 417 Symbol #5034

This symbol indicates a STANDBY

IEC 878 Symbol #0108

OFF switch. It does NOT switch the blenders mixing ability to turn power off.

IEC 878 Symbol #0107

(Circuitry OFF) position of the ON/

This symbol indicates the ON condition for display circuitry of the equipment. This symbol indicates a LOCK (used to prevent accidental

Maxtec Product Symbol

Maxtec Symbol

changes to set values.) The front panel LOCKED icon is illuminated when the control panel is LOCKED. This symbol indicates silence conditions of the audible alarm for a period of up to two (2) minutes (120sec.)

WEEE

This symbol indicates Do not

Symbol

throw away. Dispose per local governmental procedures

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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 electromagnetic components whose operation can be affected by intense electromagnetic fields. Do not operate the MAXBlendTM unattended 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 MAXBlendTM.

Regulatory Notice Federal law restricts the sale of this device except by and on order of a physician.

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Declaration of Conformity Notice

#Notes

This medical equipment complies with the Medical Device Directive, 93/42/EEC. Type of Equipment: Tradename: Model No.:

Medical Equipment, O2 Blender/Monitor Maxtec® MAXBlend™ High Flow

If you have any questions regarding the Declaration of Conformity for this product, please contact Maxtec® .

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•

The MAXBlend™ is tested for compliance with ISO 11195: 1995, clause 6, and meets requirements regarding reverse gas flow as delivered.

•

Applicable parts used in the MAXBlend™ have been cleaned and degreased for oxygen service. Any lubricants used are designed specifically for the application. Do not use anything other than Maxtec® specified lubricants when servicing the MAXBlend™.

•

As long as the total pressure of the gas mixture being monitored is constant, the MAXBlend™ will accurately read oxygen concentrations. However, if the total 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, set to 50±5 PSIG(3.4± .4 BAR), which display system pressure.

•

All specifications assume the following standard environmental conditions, unless specified otherwise. Ambient and sample gas temperatures of 77oF (25oC); barometric pressure of 30:Hg (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 O2 concentrations. The clinician should use the MAXBlend’s display panel to adjust the O2 concentration to the desired setting.

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PLEASE CAUTIONS •

•

Dropping or severely jarring the sensor after calibration may shift the calibration point enough to require recalibration.

Attempting to operate the MAXBlend™ without fully understanding its features and functions may result in unsafe operating conditions. Read the Safety Information section. It lists warnings, cautions, and notes pertinent to the safe servicing of the MAXBlend™. If you have a question regarding the installation, setup, operation, or maintenance of the MAXBlend™, contact:

•

Using the MAXBlend™ to analyze and monitor oxygen concentrations other than at the sensor port of the unit will require recalibration of the sensor.

Customer Service Hours: (MST)

•

•

xvi

Do not attempt to clean the MAXBlend™ with cleaning agents that contain phenols, ammonia chloride, or chloride compounds, or that contain more than 2% glutaralderhyde. These agents may damage the plastic components and control panel overlays.

Read this entire manual before attempting to operate or service the MAXBlend™:

Always operate the MAXBlend™ with clean, dry medical grade gases. Contaminates or moisture can cause defective operation. Oxygen should have a minimum dewpoint of -80oF (-62oC) or moisture content less than 7.9 PPM (0.0059mg/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 5oF (-15oC) 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 103 milligrams H2O per cubic meter of non-condensible gas.

Phone:

8:00 AM to 5:00 PM Monday through Friday

Fax:

(800) 748-5355 (801) 266-5300 (801) 270-5590

Technical Service Hours: (MST)

8:00 AM to 5:00 PM Monday through Friday

Phone: Fax:

(800) 748-5355 (801) 266-5300 (801) 270-5590

When disassembling, care must be exercised to prevent damaging the printed circuit board. All work must be accomplished in a static safe enviroment.

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TABLE OF CONTENTS Operator Safety Information ... xi Terms ... xi Symbols ... xi Equipment Symbols ... xix Warnings ... xii Cautions ... xvi Notes ... xvii

CAUTIONS •

Do not store the MAXBlend™ in hot areas for prolonged periods of time. Temperatures above 80oF (27oC) can shorten battery life.

•

To minimize the potential for electrostatic shock, do not use antistatic or electrically conductive hoses with the MAXBlend™.

•

The use of oxygen sensors not produced specifically for use with the MAXBlend™ may result in performance that does not conform to stated specifications in this manual. MAXTEC® RECOMMENDS MAXTEC® REPLACEMENT SENSORS WITH THE MAXBLEND™.

•

Do not clean or dry the MAXBlend™ with a high pressure air gun. Applying high pressure air to the MAXBlend™ may damage components and render the system inoperable.

•

Do not over clean the MAXBlend™. Repeated use of a cleaning agent can cause residue buildup on critical components. Excessive residue buildup can affect the MAXBlend’s performance.

•

When cleaning the MAXBlend™: Do not use harsh abrasives. Do not immerse the MAXBlend™ in liquid sterilizing agents or liquids of any kind. Do not spray cleaning solution directly onto the front panel, sensor port or bleed muffler. Do not allow cleaning solution to pool on the front panel,sensor port or bleed muffler.

•

Do not sterilize the MAXBlender. Standard sterilization techniques may damage the blender.

•

If the MAXBlend™ does not function as outlined in Chapter 2, contact a Maxtec® trained service technician or Maxtec® for service.

Chapter 1 Introduction ... 1-1 Intended Use ... 1-1 Front Panel Functional Description ... 1-2 Bottom View ... 1-6 Disposable Galvanic O2 Sensor ... 1-8 What You Will Need to Operate the Blender ... 1-8 What To Do If The MAXBlend™ Fails ... 1-9 How to Get Help ... 1-9

Chapter 2 Operating Procedures ... 2-1 Alarm Setting Procedure ... 2-1 Monitoring ... 2-1 Basic Operation ... 2-3 Alarms and Conditions ... 2-4 Calibration Procedure ... 2-4 Automatic Calibration to Known Concentration ... 2-7

Chapter 3 Performance Check ... 3-1 Pressure Differential Alarm/Bypass Check ... 3-1

Chapter 4 Troubleshooting ... 4-1 Chapter 5 Cleaning The MAXBlend™ ... 5-1

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Chapter 6 Service and Maintenance ... 6-1

WARNINGS •

Consult a physician for appropriate FiO2 settings.

•

An air inlet/water filter is recommended for use with the MAXBlend™.

•

If the MAXBlend™ does not function as described below, contact your Maxtec Distributor. Do not use the MAXBlend™ until correct performance has been verified.

•

•

Galvanic O2 sensor electrolyte gel may be acidic and may cause skin or eye irritation and/or burns. Take care when handling or replacing exhausted or damaged disposable O2 sensors. Be sure to dispose of expired sensors in accordance with hospital and/or governmental regulations. (O2 Sensor MSDS upon request Maxtec®, Inc. Phone: (801) 266-5300) Do not operate the MAXBlend™ unless qualified personnel are in attendance to promptly respond to alarms, inoperative conditions, or sudden malfunctions.

Maintenance ... 6-1 Disposable Galvanic O2 Sensor ... 6-2 Servicing ... 6-3

Appendix A Glossary ... A-1 Appendix B Specifications ... B-1 High Flow Instrument Specifications ... B-1 Alarm Specifications ... B-2 O2 Sensors ... B-2 Disposable Galvanic O2 Sensors ... B-3

Appendix C Setup and Installation ... C-1 Battery Installation ... C-1 Sensor Installation ... C-2

Appendix D Theory of Operations ...

D-1

Appendix E Flow Characteristics ... E-1 High Flow Model ... E-1

Appendix F Factors Influencing Calibration ... F-1 •

This device has not been tested in presence of gases other than air and/or oxygen.

Appendix G Ordering Information ... G-1 Appendix H Index ... H-1

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List of Figures WARNINGS Fig. Description 1.1 1.2 1.3 6.1 C.1 D.1 E.1 E.2

x

Page No.

Front Display Bottom View Sensor Galvanic O2 Sensor Battery Installation Flow Diagram Outlet Pressure Drop at Flow for High Flow Model Ave. Outlet Flow at Various Inlet Pressures for High Flow Model

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1-2 1-7 1-8 6-2 C-1 D-1 E-1 E-1

•

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 FiO2 and flow output from the MAXBlend™.

•

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 FiO2 and flow output from the MAXBlend™.

•

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 reed alarm during clinical use.

•

DO NOT occlude the sensor port on the side of the MAXBlend™.

•

DO NOT routinely disconnect or remove O2 sensors from the MAXBlend™. If the sensor must be disconnected, the full “warm-up” period, as stated in the sensor specifications, may be required after the sensor is reconnected.

•

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 as electrosurgical equipment or defibrillators.

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OPERATOR SAFETY INFORMATION

WARNINGS

Please review the following safety information prior to operating the MAXBlend™:

The following warnings apply any time you operate or service the MAXBlend™: •

•

•

•

•

xii

To avoid explosion, do not operate the MAXBlend™ in the presence of flammable anesthetics or in an atmosphere of explosive gases. Operating the MAXBlend™ in flammable or explosive atmospheres may result in fire or explosion. DO NOT operate the MAXBlend™ 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 occurring by the MAXBlend™. Alarms indicate conditions that require your immediate attention. DO NOT use parts, accessories, or options that have not been authorized for use with the MAXBlend™. Using unauthorized parts, accessories, or options may be harmful to the patient or damage the MAXBlend™.

TERMS WARNINGS

identify conditions or practices that could result in serious adverse reactions or potential safety hazards.

CAUTIONS

identify conditions or practices that could result in damage to the MAXBlend™ or other equipment.

NOTES

identify supplemental information to help you better understand how the MAXBlend™ works.

SYMBOLS

Check all audible and visual alarms daily to make sure they are operating properly. If an alarm fails to activate, contact your Maxtec Certified Service Technician.

•

Consult a physician to determine concentration of inspired oxygen to be delivered.

•

DO NOT operate the MAXBlend™ without setting the adjustable alarms. All adjustable alarms must be set to ensure safe operation.

•

Explosion hazard. DO NOT gas sterilize the MAXBlend™.

•

DO NOT steam autoclave or otherwise subject the MAXBlend™ to temperatures above 122oF (50oC).

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This symbol indicates a WARNING.

This symbol indicates a CAUTION.

# Operator’s Manual

This symbol indicates a NOTE.

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INDEX

INDEX

F

Index

O Operating Theory D-1 Operational Procedures 2-1 Ordering Information G-1 Outlet Port 1-5, 1-6 Oxygen concentration discrepancy 4-1 Oxygen Concentration Selector Control 1-6 Oxygen Inlet Adapter 1-6 Oxygen Inlet Connector 1-6

Factors Influencing Calibration F-1 Front Panel Functional Description 1-2

Symbols

G

% Sign 1-3 “↑” and “↓” Keys 1-3

Gas Outlet D-2 Glossary A-1

A

H

Alarm Setting Procedure 2-1 Alarm Specifications B-2 Alarm/Bypass Function D-2 Alarms and Conditions 2-3 Accessories G-1

P Performance Check 3-1 Power ON/OFF Key 1-3 Pressure Differential Alarm Sounding 4-1 Pressure Differential Alarm/ Bypass Check 3-1 Pressure Differential Reed Alarm Cap 1-7 Pressure Effect F-1 Problem Troubleshooting 4-1

High Alarm Display 1-5 High Alarm Setting 2-2 High Alarm Visual Display 1-5 HIGH SET Key 1-4 Humidity Effect F-2

B

I

Basic Operation 2-3 Basic Troubleshooting 4-1 Battery Installation C-1 Battery Low Indicator 1-2 Block Diagram D-3 Bottom View 1-6 Bypass mode 4-2

S

C

Sensor Installation C-2 Servicing 6-3 Set Up and Installation C-1 Sign, % 1-3 Silence Key 1-4 Specifications B-1

Calibrate 4-2 Calibrate Key 1-3 Calibration Procedure 2-4 Cleaning 5-1, 6-1

D

T

Display 1-2 Disposable Galvanic O2 Cell 1-8 Distorted display 4-2 Dovetail Mount Adapter 1-6

Temperature Effect F-1 Theory of Operations D-1 Troubleshooting 4-1

E

Instrument Specifications B-1 Intended Use 1-1

L Lock Key 1-3 Low Alarm Display 1-5 Low Alarm Setting 2-1 Low Alarm Visual Display 1-5 LOW SET Key 1-4

M Maintenance 6-1 MAXBlend Disposable Galvanic O2 Sensor 1-8, 6-2 MAXBlend O2 Sensors B-2 MAXBlend Setup C-1, D-1 Medical Air Inlet Adapter 1-6 Medical Air Inlet Connector 1-5 Mixing Operation D-1 Monitoring 2-1

Electrical Block Diagram D-3

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INTRODUCTION

INTRODUCTION

CHAPTER 1 INTRODUCTION The MAXBlend™ is a compact air/oxygen gas mixing device which incorporates the use of a battery powered oxygen monitor. The gas mixing device (blender) provides for precise mixing of medical grade air and oxygen, while the monitor measures the selected oxygen concentrations from the blender’s gas flow and samples and displays these measured concentrations on a digital display. The monitor provides high and low alarm limits which, when exceeded, cause an audible/visual alarm to activate. The MAXBlend™ design allows for a wide scope of applications including:

•

Free-flow oxygen administration

•

Mechanical ventilation of adults, pediatrics, and neonates

•

Continuous Positive Airway Pressure (CPAP)

Intended Use The MAXBlend™ 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.

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INTRODUCTION

Front Panel Functional Description A

Display A digital liquid crystal display provides direct readout of oxygen concentrations in the range of 0% to 100%. It also displays CAL when the calibration mode is entered.

B

Battery Low Indicator The low battery indicator appears on the LCD display when the power supply voltage drops below acceptable limits. When LOW BAT icon is visible, batteries should be replaced.

A C B N

20.9% LOW BAT

LOW

G

25

ATTACH SENSOR

LOCKED

J

HIGH

68

M

H

I

L

K

F

D E

R

P

Q

O

Figure 1.1 Front Display 1-2

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INTRODUCTION

INTRODUCTION C

% Sign In the calibration mode, the% sign flashes every second.

D

Power ON/OFF Key This key is used to turn on or off. The blender will continue to function and deliver mixed gas with display turned to OFF. When the ON/OFF key is pressed once, the MAXBlend™ will start to display the oxygen concentration and the keypad is activated. If the ON/OFF key is pressed again, the MAXBlend™ reverts to the display power off mode.

E

Lock Key Pressing the LOCK key will unlock the keypad and cause the LOCKED icon to disappear from the LCD readout. The MAXBlend™ can then be calibrated and alarm settings can be changed if desired. If no other keys are pressed within 10 seconds, the LOCKED icon will reappear and the unit will revert to the LOCKED mode. When the unit is in the unlocked state, pressing the LOCK key will also cause the LOCKED icon to reappear.

F

Calibrate Key When the keypad is unlocked, the CAL key is used in ↓ arrow keys to calibrate conjunction with the ↑ and↓ the MAXBlend™. When the CAL key is pressed, CAL appears on the LCD readout for 1 second and then the measured calibration, the % sign will flash at a one per second rate. When the calibration value is set, pressing the CAL or LOCK key will cause the unit to exit the calibrate mode and return to normal operation. The unit will also revert to normal operation if 10 seconds elapse and no keys are pressed.

G

↑ and ↓Keys The ↑ and ↓ arrow keys are used to adjust settings or to calibrate the MAXBlend™. When used after pressing the CAL key, pressing the ↑ or ↓ will raise or lower the displayed oxygen value in .1%

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INTRODUCTION

INTRODUCTION increments. When either of these keys are held down for more than 1 second, the display will scroll at a rate of .4% per second. When used after pressing either the LOW SET or HIGH SET keys, pressing the ↑ or ↓ key will raise or lower the displayed alarm setting in 1% increments. In the alarm set mode, holding these keys down for more than 1 second will cause the display to scroll at a rate of 4% per second.

•

Pressurized Air. The air source must provide clean, dry, medical grade air at a line pressure of 40 to 60 PSIG (2.8 to 4.2 bar).

What To Do If The MAXBlend Fails If a condition is detected that could possibly prevent the blender from continuing to operate safely, it will

H

LOW SET Key

sound an alarm. If at any time, Erx is displayed (i.e.

When the keypad is unlocked, pressing the LOW SET key will cause the LOW icon to flash. The low alarm setting can then be changed using the ↑ and ↓ arrow keys. When the low alarm value is set and the LOW SET or LOCK key is pressed again, the MAXBlend™ exits the alarm set mode and returns to normal operation. The MAXBlend™ will also revert to normal operation (storing the most recent alarm value) if 10 seconds elapse and no keys are pressed. I

Maxtec certified service technician.

WARNING Do not operate the blender unless qualified personnel are in attendance to promptly respond to alarms, inoperative conditions, or sudden malfunctions.

HIGH SET Key When the keypad is unlocked, pressing the HIGH SET key will cause the HIGH icon to flash. The high alarm setting can then be changed using the ↑ and ↓ arrow keys. When the high alarm value is set and the HIGH SET or LOCK key is pressed again, the unit exits the alarm set mode and returns to normal operation. The unit will revert to normal operation (storing the most recent alarm value) if 10 seconds elapse and no keys are pressed.

J

Er1, Er4, etc.) appears on the LCD. Contact a

How to Get Help

Customer Service and Technical Service Hours: 8:00am to 5:00pm Monday through Friday (MST) Phone: (801) 266-5300

Silence Key

Fax:(801) 270-5590

(800) 748-5355 In an alarm condition, pressing the SILENCE key will deactivate the alarm beep, but the alarm LED and display will continue to flash. In 120 seconds, the alarm beeper will sound again. This process will be repeated until the alarm condition is cancelled. The concentration must be raised .1% higher than the alarm setting (in the presence of a low alarm condition) or .1% lower than the alarm setting (in the presence of a high alarm condition).

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INTRODUCTION

INTRODUCTION K

Disposable Galvanic O2 Sensor The sensor 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 at a gold cathode. Oxygen ions are transported in the unique electrolyte solution to a lead anode where oxidation occurs, generating an electrical current. 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 chemical reaction and therefore, no current is produced. In this sense, the sensor is self-zeroing.

A red indicator light which illuminates when the high alarm limit has been exceeded. L

M

Disposable Galvanic O2 Cell (Refer to Figure 1.3)

O

A replaceable cartridge which contains the active elements of the galvanic oxygen sensor. When exhausted, the cell is discarded and replaced with a new cell.

Outlet Port A diameter indexed (DISS) oxygen fitting which, when connected with a pneumatic metering device (such as a flowmeter) delivers the following flow: MAXBlend Model High Flow

What You Will Need to Operate the Blender Pressurized Oxygen. The compressed oxygen source must provide clean, dry, medical grade oxygen at a line pressure of 40 to 60 PSIG (2.8 to 4.2 bar).

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Low Alarm Display 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. In the low alarm set mode, the LOW icon will flash at a one second rate. In a low alarm condition, the low alarm value will flash in conjunction with the low alarm LED.

Figure 1.3 Sensor

1-8

High Alarm Display 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 in the high alarm set mode, the high icon will flash at a one second rate. The high alarm value will flash in conjunction with the high alarm LED.

N

•

Low Alarm Visual Display A red indicator light which illuminates when the low alarm limit has been exceeded.

A

A

High Alarm Visual Display

P

Flow Rate 2-100 LPM

Medical Air Inlet Connector A diameter indexed (DISS) air fitting for connection to an air inlet hose from the air gas source.

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INTRODUCTION Q

Oxygen Inlet Connector

F

A diameter indexed (DISS) oxygen fitting for connection of an oxygen inlet hose from the oxygen gas source. R

Pressure Differential Reed Alarm Cap An audible alarm which, when activated, indicates that a pressure differential of 20 PSI or more exists between the two (2) gas source pressures.

Oxygen Concentration Selector Control A knob which allows for selections of mixed oxygen concentrations from 21% to 100%.

#

Note

It is important to note that the oxygen concentration selection scale is provided only as a guide for selecting O2 concentrations. The clinician should use the MAXBlend’s display panel to adjust the O2 concentration to the desired setting.

Bottom View A

#

Dovetail Mount Adapter An adapter which allows the MAXBlend™ to be mounted onto a mating bracket for mounting to a rail or ventilator system.

B

F

Outlet Port See Figure 1.1, letter O.

C

D

O2 Sensor Port A sampling port for the oxygen sensor. It allows 3 LPM of mixed gas from the blender to flow over the sensor membrane. Port is located on the back side of plate.

D

E

E A Figure 1.2 Bottom View

Medical Air Inlet Adapter See Figure 1.1, letter P.

Note: Outlet w/bleed Label MAXBlend High Flow - 2-100 LPM

Oxygen Inlet Adapter

Primary Outlet Label MAXBlend High Flow - 2 LPM

See Figure 1.1, letter Q.

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OPERATING PROCEDURES

OPERATING PROCEDURES

CHAPTER 2 OPERATING PROCEDURES Prior to placing the MAXBlend™ into clinical use, the performance check described in Chapter 3 should be performed. Refer to Appendix C for Setup and Installation.

Monitoring To begin monitoring, press the ON/OFF button 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 concentration reading, and an oxygen level returns to within limits or the limits are adjusted. To conclude monitoring, press the ON/OFF button located on the front panel. This will place the MAXBlend™ 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.

Alarm Setting Procedure Low Alarm Setting To adjust the low alarm setting: 1. Press the LOCK key to unlock the keypad.

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2.

Press the LOW SET key. The LOW icon will start to flash.

3.

Use the ↑ and ↓ arrow 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 4% per second.

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OPERATING PROCEDURES

OPERATING PROCEDURES

# Note If 10 seconds elapse between key actuations, the system will store the latest low alarm value and will revert to normal operation. If this occurs inadvertently, simply repeat the alarm setting procedure. The low alarm value cannot be set lower than 18%, 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 LOW SET or LOCK key again to accept the low alarm setting and return to normal operation.

# Note To automatically set the low alarm to 18% without scrolling the display, hold the LOW SET key down and press the ↓ arrow key when the LOW icon is flashing.

The unit will automatically enter the LOCKED condition and return to normal operation.

CAUTION •

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.

•

Dropping or severely jarring the sensor after calibration may shift the calibration point enough to require recalibration.

•

Variations in inlet gas source pressures will alter the accuracy of the oxygen readings of the MAXBlend™.

•

Using the MAXBlend™ to analyze and monitor oxygen concentrations other than at the sensor port of the unit will require recalibration of the sensor.

High Alarm Setting To adjust the high alarm setting: 1. Press the LOCK key to unlock the keypad. 2.

Press the HIGH SET key. The HIGH icon will start to flash.

3.

Use the ↑ and ↓ arrow keys to set the high alarm to the desired value.

The high alarm value cannot be set closer than 1% from the low alarm value. For example, if the low alarm is set at 50%, the system will not accept a high alarm setting less than 51%. Setting the high alarm to 100% turns off or deactivates the high alarm.

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R203M06-001 Rev E

MAXBlend TM

Operator ’s Manual

R203M06-001 Rev E

2-7

OPERATING PROCEDURES

OPERATING PROCEDURES 4.

Automatic Calibration to Room Air The MAXBlend™ can quickly be calibrated to room air (20.9%) using a quick shortcut command. This function saves time by setting the calibration value to 20.9% without scrolling the display. To use this function: 1.

Place the external probe in room air.

2.

Press the LOCK key to unlock the keypad.

3.

4.

Press and hold down the CALIBRATE key. When the % sign starts to flash, press the ↓ arrow key to set the calibration value to 20.9%.

# Note

Automatic Calibration to Known Concentration The MAXBlend™ can be quickly calibrated to the previous calibration value if a known, reliable standard is used for successive calibrations. This quick key function saves time by setting the calibration value to the last calibration value used, without scrolling the display. To use this function:

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Introduce the previously used oxygen % standard to the sensor. Press the LOCK key to unlock the keypad.

3.

Press and hold down the CALIBRATE KEY. When the % sign starts to flash, press the ↑ arrow key to set the calibration value to the primary setting.

4.

Release both the CALIBRATE key and the ↑ key. R203M06-001 Rev E

To automatically set the high alarm to 50% without scrolling the display, hold the HIGH SET key down and then press the ↓ arrow key when the HIGH icon is flashing. To automatically turn off the high alarm or set it to 100%, hold the HIGH SET key down and then ↑ arrow key when the HIGH icon is flashing. press the↑

To check the oxygen concentration of a sample gas: 1. Place the sensor probe in the sensor port on the MAXBlend™. If using a standard T adapter in an alternate location, make sure the sensor is mounted in the adapter with the flow diverter pointing downward. This will prevent moisture from draining into the sensor membrane.

Release both the CALIBRATE key and the ↓ key.

2.

Note

Basic Operation

The unit will automatically enter the LOCKED condition and return to normal operation.

1.

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When the high alarm value is set, press the HIGH SET key again to accept the high alarm setting and return to normal operation.

It is important that a tight fit exists between the probe and the T adapter. 2.

Initiate flow of the sample gas to the sensor.

3.

Using the ON/OFF key, make sure the MAXBlend™ is in the power on mode.

4.

Allow the oxygen reading to stabilize. This normally takes about 30 seconds or more.

Alarms and Conditions In the event of either a low alarm or high alarm condition, the corresponding LED will begin to flash, accompanied by the alarm buzzer. Pressing the SILENCE 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 condition still exists 120 seconds after silencing the alarm buzzer, the buzzer will start to sound again.

MAXBlend TM

Operator ’s Manual

R203M06-001 Rev E

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