Air/Oxygen Blender Instruction Manual Rev 6 April 2018

TABLE OF CONTENTS

ADDENDUM 1 (Bleed Knob) & ADDENDUM 2 (Bleed Switch)... 3 RECEIVING/INSPECTION... 4 READ ALL INSTRUCTIONS BEFORE USING... 4 DEVICE DESCRIPTION... 4 INTENDED USE... 4 WARNINGS AND CAUTIONS... 4 EXPLANATION OF SYMBOLS... 5 SPECIFICATIONS... 6 INTRODUCTION AND OPERATION... 7 SETTING UP THE BLENDER... 8 TESTING THE BLENDER... 8 USING THE BLENDER... 9 TROUBLE SHOOTING GUIDE... 10 BLENDER WARRANTY... 11 CLEANING INSTRUCTIONS... 11

MODEL IDENTIFIER LOW FLOW BLENDERS NEO2 Blend with Unique Bleed Switch

Blender with ON/OFF Knob

Standard Low Flow

Unique ON/OFF Bleed switch Blender with 2 assembled Flowmeters

Blender equipped with ON/OFF Bleed Knob

Versatile 2 Port Blender

6750-0018-9XX

6750-0020-9XX

6750-0019-9XX

HIGH/LOW FLOW BLENDERS High/Low with Unique Bleed Switch

3 Ports

6750-0025-9XX

6750-0026-9XX

Unique ON/OFF Bleed switch Blender with 1 assembled Flowmeter

2

Standard High/Low Flow 6750-0024-9XX

High/Low Blender with 3 Ports

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Versatile Blender with right and bottom Port

ADDENDUM 1Bleed Knob Model: 6750-0019-9XX Low Flow with Bleed Knob Blender model 6750-0019-9XX has a bleed knob that has been installed in lieu of the right side output port. This enables the user to maintain accurate concentrations when using the bottom or left outputs for all flows within the specification of the blender with a simple turn of the knob. A label attached to the side of the blender indicates how to position the knob for accurate concentrations at settings less than or greater than the flow rate indicated. The knob must be pushed in prior to turning. ADDENDUM 2Low Flow with Bleed Switch (NEO2 Blend) Models: 6750-0018-9XX (Right and Left Flowmeter) Blender models 6750-0018-9XX is always offered with assembled flowmeters. The flowmeter on the right side is mounted to a uniquely designed rotating bleed switch that is used in the same manner as the knob described in Addendum 1. Any time these blenders are used in a flow range requiring the bleed to be active (see the Flow Table in Section 4), rotating this flowmeter as described below will activate the bleed as well as the flowmeter. Even if the flowmeter is not to be used, positioning it vertically so the bleed is active allows the blender to be used with its lower flows. The flow rate for these flowmeters should be set using the center of the ball. RIGHT SIDE FLOWMETER The right side flowmeter and the blender bleed are inactive when the flowmeter is angled towards the front of the blender. To activate the flowmeter and initiate the required bleed for lower flows, push the flowmeter in towards the side of the blender and then rotate it clockwise (towards the back) to its vertical position. The internal bleed will now be active and the flow rate may be set using the knob on the flowmeter. As long as the flowmeter is in this position, any output port can be used for low flows even if the flowmeter itself is not being used. To return the flowmeter and bleed to its off (inactive) state, return it to its angled position by pushing it in and rotating it counterclockwise (towards the front). LEFT SIDE FLOWMETER CAUTION: The flowmeter on the left side is stationary. Do not try to turn it. If the flowmeter on the left side is to be used for flows requiring a bleed for accuracy (see the Flow Table in Section 4), be sure the knob (see Addendum 1) or right-side flowmeter (see above) is set properly. This flowmeter is meant for flows above 3 LPM. It may, however, be used below 3 LPM with the following consideration; when set below 3 LPM, turn on the required bleed by setting the right side flowmeter to its vertical position following the procedure as described above. Even though the flowmeter on the right is not being used, having it in the vertical position activates the internal bleed thereby guaranteeing O2 accuracy while using the left side flowmeter at flows below 3 LPM. High-Low with Bleed Switch Blender 6750-0026-9XX (Right Flowmeter) Blender models 6750-0026-9XX are always offered with an assembled flowmeter. The flowmeter on the right side is mounted to a uniquely designed rotating bleed switch that is used in the same manner as the knob described in Addendum 1. Any time these blenders are used in a flow range requiring the bleed to be active, rotating this flowmeter as described below will activate the bleed as well as the flowmeter. Even if the flowmeter is not to be used, positioning it vertically so the bleed is active allows the blender to be used with its lower flows. The flow rate for these flowmeters should be set using the center of the ball. RIGHT SIDE FLOWMETER The right side flowmeter and the blender bleed is inactive when the flowmeter is angled towards the front of the blender. To activate it and initiate the required bleed for lower flows, push the flowmeter in towards the side of the blender and then rotate it clockwise (towards the back) to its vertical position. The internal bleed will now be active and the flow rate may be set using the knob on the flowmeter. As long as the flowmeter is in this position, any output port can be used for low flows even if the flowmeter itself is not being used. To return the flowmeter and bleed to its off (inactive) state, return the flowmeter to its angled position by pushing it in and rotating it counterclockwise (towards the front).

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RECEIVING/INSPECTION: Remove the Ohio Medical LLC Air/Oxygen Blender from the packaging and inspect for damage. If there is any damage, DO NOT USE and contact your dealer or service representative. READ ALL INSTRUCTIONS BEFORE USING: This instruction manual is provided for your safety and to prevent damage to the Air/ Oxygen Blender. This manual instructs a professional to install and operate the Air/Oxygen Blender. If you do not understand this manual, DO NOT USE the Air/Oxygen Blender and contact your dealer or service representative. DEVICE DESCRIPTION: The Ohio Medical LLC Air/Oxygen Blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required. INTENDED USE: The Ohio Medical LLC Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric and adult patients.

1. WARNINGS AND CAUTIONS WARNINGS If the pressure of the oxygen or air gas source increases or decreases, resulting in a 20 psi (138 kPa) difference, the alarm will sound. This will affect the blender’s output flow and oxygen concentration. The blender alarm will sound if the air or oxygen gas source fails. This indicates to the user that the oxygen concentration or flow may not be accurate. A physician must determine the correct FIO2 setting. •

The blender MUST NOT be exposed to extremely high temperatures, as in the case of steam autoclaving (which could reach 145 degrees F/ 62 degrees C)

•

DO NOT autoclave.

•

The alarm shoud not be obstructed, removed or tampered with.

•

The blender is designed to operate from a 50 psig (345 kPa) source of air and oxygen.

•

Before use on a patient, the oxygen concentration of the delivered gas should be checked at the setting intended for use. A separate, calibrated oxygen analyzer (complying with ISO 7767) should be used whenever the blender is used on a patient.

•

The bleed port on the bottom of the blender must not be covered at any time.

•

NEVER leave a ventilator patient unattended.

•

Some special order blenders may not have a bleed when using the right side outlet. When this is the case, the flow specifications for “flow without bleed” apply to the auxiliary outlet.

•

The factory installed air and oxygen gas supply fittings, which contain essential check valves and filters, must not be substituted with any other parts not approved by Ohio Medical LLC. Doing so may cause gas supply contamination due to back flow. 4

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CAUTIONS • Moisture or dirt can affect the operation of the blender. •

A clean dry gas source must be used at all times.

•

The air must meet “USP grade” compressed air (standard formerly ANSI Z86.11973 grade F) and at 75 PSI (517 kPa) water vapor content cannot exceed a dew point of 5°F (2.8°C) below the lowest ambient temperature to which the blender and accessories are exposed.

•

The oxygen should be “medical oxygen” that is, at least 99.0% pure. Both gases must contain <37.5 milligrams of water per cubic meter of gas (mg/Nm3) or (<50 ppm H2O).

•

A water trap assembly and filter must be used to avoid malfunction should water accidentally getting into the gas supply sources.

•

Do not use in a MRI room unless the blender has been built to be used for such an environment. This will be indicated by “MRI” on the blender.

•

The flowmeter on the left side of the NEO2 blender is stationary. Do not try to turn it.

•

If the blender does not pass the performance test, do not place the unit into service; call your dealer or service representative.

Note: This blender has been degreased for oxygen service prior to delivery. Note: The upper flow limit is the total flow that the blender will pass, not the limit per port.

2. EXPLANATION OF SYMBOLS Refer to manual for proper method of operation

Date of Manufacture

Refer to manual for proper method of operation Warning: Condensed water in air supply can cause malfunction of this device Warning: Do not obstruct alarm or bleed holes in the bottom of this device Caution: Federal law restricts this device to sale by or on the order of a licenced healthcare practitioner

SN

REF

Serial Number Catalog Number The CE Mark displayed on this product signifies that this device is in compliance with the European Medical Devices Directive (Council Directive 93/42/EEC). As a perquisite for the CE mark, Bio-Med Devices operated under an ISO 13485 compliant quality system (covering the design and manufacture of medical devices). The four-digit code underlying the CE mark (0086) pertains to Bio-Med’s Notified Body, the British Standards Institute, whose function is to investigate and attest to the validity of CE-mark claims.

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3. SPECIFICATIONS

Configurations available deliver accurate FIO2 mixtures from one (1) up to three (3) outlet ports allowing the blender to power three items at once. Several flow ranges are available. They can be used with ventilators, nasal cannulas, mask CPAP and resuscitation bags. The Low Flow version of the blender provides flows from 3 to 30 LPM with no gas bleed. The high/low blender provides flow from 15-20 LPM with no gas bleed. MRI conditional versions that are made entirely of non-magnetic materials are also available. Device-Specific Standards: Complies with ISO 11195 : 1995. Oxygen % Range: 21 to 100% Oxygen % Accuracy: ±3% of full scale Supply Pressure: Both supplies within range of 30-75 PSI (207-517 kPa) and Air & oxygen must be within 10 psi (69 kPa) of each other. *Do not use on a patient or with a ventilator outside of this range. *Blender performance with supply pressures below range (0-30 PSI / 0-207 kPa) cannot be predicted. Due to low output pressure, it will not be able to adequately drive a ventilator. Not for patient use. Blender performance with supply pressures above range (75-112.5 PSI / 517775 kPa) with supplies balanced, available output flows and oxygen percentages will remain consistent with specification. Output pressures will be proportionally higher and may damage the ventilator. Not for patient use. Maximum Flow: ≥120 LPM High/Low Flow Blender (≥30 LPM, Low Flow Blender) @ 60% setting & 50 PSI (345 kPa) inlet pressures. Standard Flow Ranges: refer to table in Section 4. Custom Configuration Flow Ranges: refer to addendum and table in Section 4. Pressure Drop: <6 psi (42 kPa) at 50 psi (345 kPa) inlet pressure and 40 LPM flow (10 LPM, Low Flow blender). Low Supply Alarm: as described in Section 4. Alarm/Bypass Reset: when inlet gas pressure differential is ≥6 psi (42 kPa). Alarm Intensity: 80 dB at 1 foot. Input fittings: Oxygen female DISS, Air male DISS. (NIST available) Output Fitting(s): Male DISS, oxygen type. Dimensions:

Height 3 1/2” (8.9 cm) Width 2 1/4” (5.7 cm) Depth 2 7/8” (7.3 cm)

Weight: 2.35 lbs (1.07 kg)- basic low flow model with plastic chamber plates or 3.15 lbs (1.43 kg)- basic low flow model with aluminum chamber plates No electronics incorporated. Reverse Gas Flow: From either gas inlet to the other is zero (complies with clause 6 of ISO 11195).

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4. INTRODUCTION AND OPERATION

This Air/Oxygen Blender is a precision proportioning device for mixing medical grade air and oxygen to any concentration from 21% to 100% oxygen and delivering it to a variety of respiratory care devices. The blender uses source air and oxygen at a pressure of 50 psi (345 kPa) connected to two D.I.S.S. fittings on the bottom of the blender. Each fitting has a built-in 30 micron particulate filter. The gas source passes through a duckbill check valve which prevents reverse gas flows from either source. The blender uses a double stage balancing system with the gas entering into the first stage to equalize the operating pressure of the gas sources before entering the proportioning stage. The gases then flow into the proportioning stage where they are mixed to the percentage dialed in on the front panel knob. This stage has a double-ended valve with valve seats on either end. Each one of these valve seats controls the passage of the air or oxygen to the outlet of the blender. Many different configurations of blenders and output ports are available. The model number can be found on the back of the blender. See ‘Model Identifier’ on page 2 or use the front of the blender to identify which row to use in the table below to determine its flow range. The blender will be Low Flow or High/Low Flow. The flow limitations listed below apply, regardless of what is attached to the port. If the bleed is active, the “flows with bleed” applies to all output ports. Conversely, if the bleed is inactive, the “flows without bleed” applies to all ports. NOTE: The upper flow limit is the total flow that the blender will pass, not the limit per port. As an example, if 30 LPM is passing through any one port on a Low Flow blender, then no other port should be used as 30 LPM is the upper flow limit for this blender. The bleed referred to in the table and elsewhere in this manual is activated in one of three ways depending on what is on the right side of the blender. If there is a DISS fitting, attaching a device to this fitting will turn on the bleed1. If there is a knob, setting it to the “<” position will turn on the bleed (see Addendum 1). If there is a flowmeter on a switch mounted here, rotating it to its vertical position will turn on the bleed (see Addendum 2). If none of these options are available on the right side, then the bleed cannot be turned on and off. FLOW TABLE: Model

Flow Range without Bleed

Low Flow

3-30 lpm

Flow Range with Bleed 0-30 lpm (3 lpm Bleed)

High/Low Flow

15-120 lpm (No Bleed)

2-108 lpm (10-12 Bleed)

WARNING: Some special order blenders may not have a bleed when using the right DISS outlet. When this is the case, the flow specifications for without bleed apply. 1

Note: The NEO2 Blend conforms to the Low Flow configuration with flow limited by the flowmeters. Refer to Addendum 2 in the beginning of this manual. 6700-0494-200 (Rev.6) 04-2018

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The blender has an audible built in alarm which detects if either of the gas sources changed by more than 20 psi (138 kPa) from the other. The alarm will warn the user that they are running out of one of the gas sources or that there is a severe pressure drop in one source. If both gas sources drop or increase together such that a 20 psi (138 kPa) difference cannot be detected, no alarm will sound. If the blender is connected but not being used and a 20 psi (138 kPa) difference in gas sources develops, the blender will not alarm. The blender alarm/bypass function will provide > 90 LPM (the full 30 LPM, Low Flow Blender) upon the loss of air or oxygen, if the remaining gas is at 50 psi (345 kPa)

5. SETTING UP THE BLENDER

The blender can be either pole, wall, or rail-mounted for easy use and for any desired application. The inlet fittings are located on the bottom of the blender and conform to Diameter Index Safety System (D.I.S.S.) and air and oxygen connections cannot be reversed. Connect an air high pressure hose to the air fitting and an oxygen high pressure hose to the oxygen fitting on the bottom of the blender. It is recommended that an air inlet water trap be used between the air hose and inlet fitting to prevent moisture from entering the blender. The primary outlet (see Addendum 1) on the bottom of the standard high flow blender is appropriate for high flow situations, as with most ventalators requiring flows up to 120 LPM. Flows of less than 15 LPM (3 LPM, Low Flow blender) require the right side outlet (bleed knob or bleed switch). If both outlets are used simultaneously, neither one will deliver its maximum flow.

6. TESTING THE BLENDER

The following checks should be performed before placing the blender into service. Note: If the blender does not pass these checks do not place the unit into service; call your dealer or service representative. •

Connect the 50 psi (345 kPa) air and oxygen sources to the appropriate fittings and set the blender to 60% (the alarm should not activate).

•

Check to ensure that the oxygen concentration is actually 60% by using a calibrated oxygen analyzer (conforming with ISO 7767).

•

Disconnect the oxygen source from the blender and listen for the audible alarm. Once it alarms, reconnect the oxygen to stop the alarm.

•

Verify the oxygen concentration again.

•

Disconnect the air source from the blender and listen for the audible alarm

•

Once it alarms, reconnect the air and verify the oxygen concentration again.

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7. USING THE BLENDER •

Connect the gas outlet of the blender either directly or via a high pressure hose to the ventilator or other equipment with which it is being used.

•

Set the control on the front panel to the desired oxygen concentration.

•

Turn on the 50 psi (345 kPa) air and oxygen sources.

•

Set the controls on the ventilator or equipment being used.

•

Use a calibrated oxygen analyzer to check the accuracy of the patient gas.

•

When changing oxygen concentration, wait sixty seconds (equilibration time) before checking it against the analyzer.

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8. TROUBLE SHOOTING GUIDE PROBLEM

CAUSE OF PROBLEM

OXYGEN ANALYZER ANALYZER OUT OF DOESN'T AGREE WITH CALIBRATION SETTING OF BLENDER

TO SOLVE PROBLEM CALIBRATE OXYGEN ANALYZER

BLENDER OUT OF CALIBRATION

CALL SERVICE DEPARTMENT

DIRTY GAS SUPPLY

CALL SERVICE DEPARTMENT

BLEED ON BOTTOM OF CALL SERVICE BLENDER IS RESTRICTED DEPARTMENT

BLENDER ALARMING

AIR IS FLOWING INTO PIECE OF EQUIPMENT BEING USED AND DILUTING CONCENTRATION

CORRECT SITUATION BY STOPPING THE FLOW OF AIR

AIR AND OXYGEN SOURCE PRESSURES HAVE GREATER THAN 20 PSI (138 kPa) DIFFERENTIAL

BRING THE SOURCE PRESSURES WITHIN THE 20 PSI (138 kPa) RANGE

ALARM SYSTEM IS OUT OF CALIBRATION

CALL SERVICE DEPARTMENT

DIRTY GAS IS CONTAMINATING ALARM SYSTEM

CALL SERVICE DEPARTMENT

THE ONLY TIME THE BLENDER IS ACCURATE IS WHEN THE SOURCE PRESSURES ARE EXACTLY THE SAME

PRESSURE BALANCE CALL SERVICE CHAMBER NOT WORKING DEPARTMENT PROPERLY

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9. BLENDER WARRANTY

The warranty lasts for one year from date of purchase. This warranty covers parts and labor. Shipping costs are covered up to six months from the date of purchase. This warranty is limited to defects in parts and workmanship and does not cover incidents due to misuse or abuse of the product. All service must be performed by authorized service personnel. The manufacturer will not be held responsible for unauthorized service work on any blender.

10. CLEANING INSTRUCTIONS

The blender should only be cleaned by wiping the outside surfaces with alcohol applied to a tissue or cloth. These blenders should never be sprayed with or immersed in any other liquid. Be sure not to allow ingress of any appreciable quantity of alcohol into any alarm or vent holes. Never insert anything into the holes in the alarm cover.

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®

North America United States Customer Service, Distribution Center Technical Support, Sales and Service Equipment Service Center Ohio Medical LLC 1111 Lakeside Drive Gurnee, IL 60031 USA P: +1 866 549 6446 F: +1 847 855 6218 www.ohiomedical.com

© 2018 Ohio Medical, LLC. All rights reserved. This document contains information that is proprietary and confidential to Ohio Medical, LLC.Use of this information is under license from Ohio Medical, LLC. Any use other than that authorized by Ohio Medical, LLC is prohibited. Ohio Medical and the Ohio Medical logo are registered trademarks of Ohio Medical, LLC. NFPA is a registered trademark of the National Fire Protection Association. Manufactured by Bio-Med Devices Inc. distibuted by Ohio Medical LLC.

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