CATALOG 2120 AIR OXYGEN BLENDER Instruction Manual June 2005

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BIO-MED DEVICES

AIR/OXYGEN

BLENDER

INSTRUCTION MANUAL

CATALOG # 2120 REV 100605

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7. USING THE BLENDER .............................................................................................. 6

8. TROUBLE SHOOTING GUIDE .................................................................................. 7

9. CLEANING INSTRUCTIONS ......................................................................................

8

10. BLENDER WARRANTY ...........................................................................................

8

11. SERVICE RECOMMENDATIONS ............................................................................

8

APPENDIX ......................................................................................................................

9

ADDENDUM 1- Low Flow Selector Knob

A low flow selector knob has been installed on some of the Bio-Med Devices Blenders

(standard on units mounted on the Crossvent ventilators) in lieu of the auxiliary side port.

This enables the user to maintain accurate concentrations using the single primary output

for both high and low flows 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 2- NEO2 BLEND Blender

The NEO2 BLEND is a low flow blender with two flowmeters mounted to it, one on each

side. Any time this blender is used below 3 lpm, an internal bleed is required to maintain

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the accuracy of the O2 concentration being delivered. Due to the unique design of the

NEO2 BLEND, this bleed is automatically activated when the flowmeter on the right is set

to the “ON” position as described below. To conserve gas, this bleed may be turned off

when this flowmeter is not in use. The flowmeter on the right side is for delivering flows

below 3 lpm. The left flowmeter is generally used for flows above 3 lpm, but may be used

below 3 lpm as explained below.

The flow rate for these flowmeters should be set using the center of the ball.

RIGHT SIDE FLOWMETER

The right side flowmeter and corresponding bleed is inactive when it is angled towards the

front of the blender. To activate it and initiate the required bleed, 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. 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.

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.

1. WARNINGS, CAUTIONS AND NOTES

WARNINGS

If the pressure of the oxygen or air gas source increases or decreases resulting in a 20

psi* (138 kPa) difference (*30 psi [207 kPa] in the case of overseas devices and those

manufactured for Draeger / Hill Rom / Air-Shields), 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).

The alarm should not be obstructed, removed or tampered with in any way.

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

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An oxygen analyzer should be used to verify the initial patient gas concentration and

when making any adjustments to the concentration (Bio-Med Devices’ M-2 Oxygen /

Temperature Monitor or M-10 ten-function Ventilation Monitor may be used in this

capacity).

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

Never leave a ventilator patient unattended, or without remote monitoring.

Some special order blenders may not have a bleed when using the auxiliary outlet. When

this is the case, the flow specifications for the primary outlet apply to the auxiliary outlet.

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 compressed air and ANSI Z86.1-1973 grade F

and water vapor content cannot exceed a dew point of 5 degrees F. below the lowest

ambient temperature to which the blender and accessories are exposed.

A water trap assembly and filter must be used to avoid malfunction should water

accidentally get into the gas supply sources.

Do not use in a MRI room unless the blender has been built by Bio-Med Devices 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 BLEND 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.

NOTES

The NEO2 BLEND with two flowmeters conforms to the model #2003 configuration with

flow limited by the flowmeters. Refer to Addendum 2 in the beginning of this manual.

2. EXPLANATION OF SYMBOLS

Attention, See instructions for Use

Date of Manufacture

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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

prerequisite for the CE mark, Bio-Med Devices operates 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.

3. SPECIFICATIONS

Bio-Med Devices' line of blenders delivers accurate FIO2 mixtures from either one or two

outlet ports and has an overall standard flow range of 2 - 120 LPM. They can be used

with ventilators, nasal cannulas, mask CPAP and resuscitation bags. By adding an

additional side port to the standard model, three outlet ports are able to provide combined

flows from 2 -100 LPM, allowing it to power three items at once. The 0-50 LPM Blender is

a perfect compromise between the High Flow and Low Flow blenders as it requires less of

a bleed for accuracies below 6 LPM than the High Flow while allowing greater maximum

flow than the Low Flow Blender. The Low Flow version of the blender provides flows from

3 to 30 LPM with no gas bleed. Bio-Med Devices also offers MRI compatible versions that

are made entirely of non-magnetic materials.

CAUTION: Do not use in a MRI room unless the blender has been built by Bio-Med

Devices to be used for such an environment. This will be indicated by “MRI” on blender.

Oxygen % Range: 21 to 100%

Oxygen % Accuracy: ±3% of full scale

Supply Pressure: 30-75 psi (207-517 kPa) Air & oxygen must be within 10 psi (69 kPa)

of

each other.

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Maximum Flow: ≥120 LPM (≥50 LPM, 0-50 Flow blender; ≥30 LPM, Low Flow blender)

@

60% setting & 50 psi (345 kPa) inlet pressures

Standard Flow Ranges: refer to table in Section 2

Custom Configuration Flow Ranges: refer to addendums and table in Section 2

Pressure Drop: <6 psi (42 kPa) at 50 psi (345 kPa) inlet pressure and 40 LPM flow (10

LPM, Low Flow blender)

Alarm/Bypass Reset: when inlet gas pressure differential is ≥6 psi (42 kPa).

Alarm Intensity: 80 dB at 1 foot

Dimensions:

Weight:

Height 3 1/2" (8.9 cm)

Width 2 1/4"

(5.7 cm)

Depth 2 7/8" (7.3 cm)

2

3/4

lbs

(1.25

kg).

4. INTRODUCTION AND OPERATION

The Bio-Med 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 then

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.

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Depending on the model, there may be up to three gas outlets on the Bio-Med Devices

blender as outlined in the table below. The model number can be found on the back of the

1

blender. Use the first four digits to identify the configuration . Under certain custom

configurations, some ports may not be present. The flow limitations listed below apply,

regardless of what is attached to the indicated port.

Note 1. For 2002K2 with 0-50 LPM on the front of the blender, use 2000K for its configuration.

Blender Ports

B

AIR O

Model

2000K

2001

2001K

2002

2003

2004

Ports A,

Flow Range - Port “A” 6-50

Flow Range - Port “B” Flow Range - Port “C” N/A

Knob @C A,

C A, Knob

@C A B, C A,

B, C

lpm (No Bleed) 0-50 lpm (6 lpm

Bleed) 15-120 lpm (No Bleed)

15-120 lpm (No Bleed) 2-108 lpm

(10-12 lpm Bleed) 15-120 lpm (No

Bleed) N/A 15-120 lpm (No Bleed)

N/A Knob Set >6 Knob Set< 6 N/A 2-108 lpm (10-12 lpm Bleed)

N/A N/A Knob Set >15 Knob Set< 15 N/A N/A 3-30 lpm (No Bleed)

0-30 lpm (3 lpm Bleed) 15-120 lpm (No Bleed) 2-108 lpm (10-12

Bleed)

WARNING: Some special order blenders may not have a bleed when using the

auxiliary outlet. When this is the case, the flow specifications for the primary outlet

apply to the auxiliary outlet.

NOTE: The NEO2 BLEND with two flowmeters conforms to the model #2003 configuration

with flow limited by the flowmeters. Refer to Addendum 2 in the beginning of this manual.

The blender has an audible alarm built in to detect if either of the gas sources changes by

more than 20 psi* (138 kPa) from the other. This 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, then 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.

*(30 psi [207 kPa] in the case of overseas devices and those manufactured for Draeger /

Hill Rom / Air-Shields)

The blender alarm/bypass function will provide > 90 LPM (the full 30 LPM, Low Flow

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Blender) upon the loss of air or oxygen, if the remaining gas is at 50 psi (345 kPa).

5. SETTING UP THE BLENDER

The Bio-Med Devices Blender can be either pole-, wall-, or rail-mounted for easy use 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.) so that 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. Bio-Med Devices

recommends 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 Addendum1) on the bottom of the standard high flow blender is

appropriate for high flow situations, as with most ventilators requiring flows up to 120 LPM.

Flows of less than 15 LPM (6 LPM, 0-50 LPM blender; 3 LPM, Low Flow blender) require

the auxiliary outlet (side port or knob). If both outlets are used simultaneously, neither one

will

deliver

its

maximum

flow.

6. TESTING THE BLENDER

The following checks should be performed before first placing the blender into service.

Note: If the blender does not pass these checks do not place the unit into

service; call Bio-Med Devices Service Department at (203) 458-0202.

First, 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 see that the oxygen

concentration is actually 60% by using a calibrated oxygen analyzer. Disconnect the

oxygen source from the blender and listen for the audible alarm. Once it alarms,

reconnect the oxygen to stop the alarm and verify the oxygen concentration again. Next

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.

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 and 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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To use the standard high flow blender for low flow applications, connect a flowmeter to the

secondary outlet (see Addendum 1 at the beginning of this manual), and set the

concentration with the knob on the front panel. Then turn on the source gases, set the

flowmeter and check the output with a calibrated oxygen analyzer.

8. TROUBLE SHOOTING GUIDE

PROBLEM

CAUSE OF PROBLEM

TO SOLVE PROBLEM

OXYGEN ANALYZER

DOESN'T AGREE WITH

SETTING OF BLENDER

ANALYZER OUT OF

CALIBRATION BLENDER

OUT OF CALIBRATION

CALIBRATE OXYGEN

ANALYZER CALL

BIO-MED SERVICE

DEPARTMENT

DIRTY GAS SUPPLY

BLEED ON BOTTOM OF

BLENDER IS

RESTRICTED

BLENDER ALARMING

THE ONLY TIME THE

BLENDER IS ACCURATE

IS WHEN THE SOURCE

PRESSURES ARE

CALL BIO-MED SERVICE

DEPARTMENT

CALL BIO-MED SERVICE

DEPARTMENT

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 BIO-MED SERVICE

DEPARTMENT

DIRTY GAS IS

CONTAMINATING

ALARM SYSTEM

CALL BIO-MED SERVICE

DEPARTMENT

PRESSURE BALANCE

CHAMBER NOT

WORKING PROPERLY

CALL BIO-MED SERVICE

DEPARTMENT

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EXACTLY THE SAME

*(30 psi [207 kPa] in the case of overseas devices and those manufactured for Draeger /

Hill Rom / Air-Shields)

9. CLEANING INSTRUCTIONS

Bio-Med Devices' line of blenders 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.

10. BLENDER WARRANTY

The Bio-Med Devices, Inc. warranty lasts for one year from date of purchase. This

warranty covers parts and labor. Shipping costs are covered up to six months from date

of purchase. This warranty is limited to defects in parts and workmanship; Bio-Med

Devices will not be held responsible for misuse or abuse of the product.

All service must be done by Bio-Med Devices or an authorized service representative of

Bio-Med Devices. Bio-Med Devices will not be held responsible for unauthorized service

work on any blender.

11. SERVICE RECOMMENDATIONS

Periodic preventive maintenance should be performed to insure continued proper

operation of the blender. The frequency of preventative maintenance is determined

by many factors, some of which are:

Frequency & length of use

Quality of the compressed gas source(s)

Environmental conditions

Recommended Maintenance Schedule

Interval

Recommended Procedures

Prior to each use

Performance test

Every year between PM’s

Calibration certification

Every 2 years

Major overhaul, cleaning and calibration

Recommend return to factory for this service

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APPENDIX European Agent

Bio-Med Devices’ Official Agent in Europe is:

HORST HÖRNLA

H + H Intermed

Schwedenstraße 32

87463 Dietmannsried-Reicholzried

United Germany

Telefon:

Fax:

(08

(08

31)

31)

6

6

UK Agent is:

INSPIRATION HEALTHCARE LTD

Gildor House

West Street

Earl Shilton

Leicester

LE9 7EJ

United Kingdom

Telfon: 0044 (0) 1455 840555

Fax: 0044 (0) 1455 841464

31

09

86

54