USER MANUAL

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USER MANUAL | Manualzz

U S E R M A N U A L

AiR-OxygEN BLENdER

(diSS and NiST Connections)

Model No. R203P14

R203P13

(shown)

CAUTiON

SAVE THESE iNSTRUCTiONS

Federal (USA) law restricts this device to sale by or on the order of a physician.

Maxtec

6526 South Cottonwood Street

Salt Lake City, Utah 84107

USA

QNET BV

Hommerterweg 286

6436 AM Amstenrade

The Netherlands

TEL (800) 748.5355

FAX (801) 270.5590

Email : [email protected]

Website : www.maxtecinc.com

- 0123

R203M13 Rev. A

CONTENTS

RECEIVING / INSPECTION .......................................................2

INTENdEd USE .........................................................................2

REAd ALL INSTRUCTIONS BEFORE USING ..........................2

EXPLANATION OF ABBREVIATIONS .......................................2

SAFETY INFORMATION - WARNINGS ANd CAUTIONS .........3

SPECIFICATIONS .....................................................................5

dIAGRAMS ................................................................................7

COMPONENT dESCRIPTION ...................................................8

PRE-USE TESTING ...................................................................9

ALARM TEST ...........................................................................10

REVERSE GAS FLOW PROCEdURE ....................................10

OPERATING INSTRUCTIONS .................................................11

CLEANING ...............................................................................11

MAINTENANCE .......................................................................12

TECHNICAL dESCRIPTION ....................................................12

RETURNS ................................................................................12

dISPOSAL INSTRUCTIONS ....................................................12

TROUBLESHOOTING .............................................................13

1

RECEiViNg / iNSPECTiON

Remove the MicroMax Air-Oxygen Blender from the packaging and inspect for damage. If there is any damage, dO NOT USE and contact your Provider.

iNTENdEd USE

The MicroMax Air-Oxygen Blender dispenses a continuous and precise blend of medical air and USP oxygen via outlet ports to infant, pediatric and adult patients. The exact Fractional Concentration of

Inspired Oxygen (F

I O

2

) blend of gases corresponds to the dialed in F

I O

2

setting indicated by the control knob (dial).

REAd ALL iNSTRUCTiONS BEFORE USiNg

This manual instructs a Professional to install and operate the

Air-Oxygen Blender. This is provided for your safety and to prevent damage to the Air-Oxygen Blender. If you do not understand this manual, dO NOT USE the Air-Oxygen Blender and contact your

Provider.

dANgER

This product is not intended as a life-sustaining or lifesupporting device.

ExPLANATiON OF ABBREViATiONS

F

I O

2

dISS

NIST psi l/min

Fractional Concentration of Inspired Oxygen diameter Indexed Safety System

Non-Interchangeable Screw Thread

Pounds Per Square Inch

Liters Per Minute

2

SAFETy iNFORMATiON - WARNiNgS ANd CAUTiONS

dANgER

Indicates an imminently hazardous situation which, if not avoided, will result in death or serious injury.

which, if not avoided, could result in death or serious injury.

CAUTiON

which, if not avoided, may result in minor or moderate injury.

Used without the safety alert symbol indicates a potentially hazardous situation which, if not avoided, may result in property damage.

CONSULT ACCOMPANYING dOCUMENTS

OR

0123

Symbol for “USE NO OIL”

Symbol indicates the device complies with the requirements of directive 93/42/EEC concerning medical devices and all applicable International

Standards.

WARNiNg

Only trained, qualified medical personnel under the direct supervision of a licensed physician should operate the

Air-Oxygen Blender .

Use this Air-Oxygen Blender only for its Intended Use as described in this manual.

Confirm prescribed dose before administering to patient.

Monitor on a frequent basis.

The Air-Oxygen Blender shall be serviced by a qualified service technician.

Always follow ANSI and CGA standards for Medical Gas

Products, Flowmeters and Oxygen Handling.

3

WARNiNg

An Oxygen Analyzer/Monitor must be used to verify oxygen concentration.

Accuracy of oxygen concentration will be affected if bleed is not activated at flow settings below 15 l/min for the High

Flow Blender, and 3 l/min for the Low Flow Blender.

dO NOT obstruct the alarm.

dO NOT use Blender when alarm is sounding.

dO NOT use oil in or around the Blender.

dO NOT occlude or obstruct the bleed port on the auxiliary outlet of the Blender.

dO NOT use near any type of flame or flammable/ explosive substances, vapors or atmosphere.

Oxygen Concentration dial does not rotate 360 degrees.

Rotating the dial less than 21% or over 100% oxygen will damage the Blender.

CAUTiON

Turn off gas supplies when Air-Oxygen Blender is not in use.

Store the Air-Oxygen Blender in a clean, dry area when not in use.

The Air-Oxygen Blender contains magnetic, ferrous material that may affect the results of an MRI.

Ensure all connections are tight and leak free.

Avoid excessive pressure surges greater than 100 psi

(6.9 bar) when pressuring the Blender inlets.

dO NOT steam autoclave.

dO NOT immerse Air-Oxygen Blender into any liquid.

dO NOT gas sterilize with (EtO) Ethylene Oxide.

dO NOT use if dirt or contaminants are present on or around the Blender or connecting devices.

dO NOT smoke in an area where oxygen is being administered.

dO NOT clean with aromatic hydrocarbons.

Inlet pressure of device used in conjunction with Blender must match inlet pressure of Blender.

When using a bottled high pressure gas source, always use a pressure reducing regulator set within 30-75 psi (2.1-5.2 bar).

4

SPECiFiCATiONS

Model

Primary Outlet

Flow Range

Auxiliary Outlet

Flow Range

Bleed Flow

MicroMax High Flow

R203P14

15 - 120 l/min

MicroMax Low Flow

R203P13

3 - 30 l/min

With both supply pressures at 50 psi (3.4 bar) with BLEEd closed

2 - 100 l/min 0 - 30 l/min

With both supply pressures at 50 psi (3.4 bar) with BLEEd open

13 l/min or less at 50 psi (3.4 bar)

3 l/min or less at 50 psi (3.4 bar)

Maximum

Combined

Flow

(All Outlets)

Bypass Flow

(Loss of Air or

Oxygen supply)

Bypass Alarm

Activation

≥ 120 l/min

> 85 l/min

≥ 30 l/min

> 45 l/min

50 psi

(3.45 bar)

60 psi

(4.14 bar)

50 psi

(3.45 bar)

60 psi

(4.14 bar)

13-25 psi 16-24 psi 18-22 psi 16-24 psi

0.9-1.7 bar 1.1-1.65 bar 1.2-1.5 bar 1.1-1.65 bar

Alarm Reset:

When pressure differential is 6 psi

(0.4 bar) or less.

Alarm Sound Level:

≥ to 80 db at 1 ft (0.3 m)

Oxygen Concentration

Adjustment Range:

21 - 100%

gas Supply Pressure:

30 - 75 psi (2.1 - 5.2 bar)

Air and Oxygen within 10 psi (0.69 bar) of each other

Mixed gas Stability:

±1% Oxygen

Connection Types:

dISS Type - Air & Oxygen Inlets & Outlets and / or NIST Type - Air & Oxygen Inlets

Note: All flow-rate values are as measured from an Oxygen flowmeter (uncorrected).

5

SPECiFiCATiONS

continued

dimensions:

(without fittings)

Weight:

depth:

4.9 in

(12.5 cm)

Width:

2.3 in

(5.7 cm)

Height:

4.1 in (10.4 cm)

2.29 lbs

(1.04 kg)

Shipping Weight:

2.95 lbs

(1.34 kg)

Operating Temperature Range:

59°F to 104°F (15°C to 40°C)

Transport / Storage Requirements

Temperature Range:

-10°F to 140°F (-23°C to 60°C)

Humidity:

F

I O

2

Accuracy:*

Pressure drop:

Low Flow:

Max 95% Noncondensing

± 3% of full scale

≤ 2 psi (0.14 bar) at inlet pressures from 30-90 psi

(2.1- 6.2 bar) and at 10 l/min flow rate at 60% F

I O

2

.

High Flow:

≤ 3 psi (0.21 bar) at inlet pressures from 30-90 psi

(2.1- 6.2 bar) and at 30 l/min flow rate at 60% F

I O

2

.

The Air-Oxygen Blender has been cleaned for Oxygen Service prior to delivery.

The Air-Oxygen Blender reverse gas flow complies with clause 6 of ISO 11195.

The Oxygen Analyzer should comply with ISO 21647 to meet CE requirement.

dryness and Composition for inlet gases:

Air:

Medical Air supply should meet the requirements of

ANSI Z86.1 - 1973 commodity specification for Air, type

1 grade d or better.

Oxygen:

Oxygen supply must meet all requirements of USP

Medical Oxygen Grade N.

dew Point: Both inlets should remain 10°F (5.55°C) or more below the lowest temperature to which the air distribution system equipment is exposed. At a temperature of 25°F (-3.9°C) and a pressure of

90 psi (6.33 kg/cm

2

) this equates to 2000 mg/m

3

.

* Accuracy of oxygen concentration will be affected if bleed is not activated at flow settings below 15 l/min for the high flow

Blender, and 3 l/min for the low flow Blender.

Specifications are subject to change without prior notice.

6

diAgRAMS

CAUTiON

Missing or illegible labels must be replaced, contact Maxtec.

Depending on model, your fittings and/or labels may differ from these diagrams.

R203P13 Model

R203P14 Model

B

E

F

H

C d

G

7

A

COMPONENT dESCRiPTiON

ITEM DESCRIPTION

A Oxygen Concentration dial

A dial used for selecting oxygen concentrations between

21%-100%. The F

I O

2

scale is used for reference only.

This dial does not rotate 360°. The dial starts at 21% and ends at 100%.

B Primary Outlet Port

A male DISS oxygen fitting with check valve that delivers flow when engaged to any controlling device, such as a flowmeter.

C Auxiliary Outlet Port

A male DISS oxygen fitting with check valve that delivers flow when engaged to any controlling device, such as a flowmeter. This outlet is equipped with a bleed valve that allows the user to control if the bleed is ON or OFF.

With the bleed in the ON position, this outlet delivers accurate oxygen concentrations in the following flows:

Model

High Flow

Low Flow

Flow Range

2 – 100 l/min

0 – 30 l/min

d

Auxiliary Bleed Collar

The collar is used to engage and disengage the bleed.

The bleed is necessary to maintain accurate F

I O

2

Concentration below 15 l/min for the High Flow and

3 l/min for the Low Flow. To activate the bleed, slide the knurled collar back until it contacts the cover. To deactivate the bleed, pull the collar away from cover until it reaches a positive stop.

E Oxygen inlet Fitting

A female DISS or NIST oxygen fitting with one way valve that is used to connect an oxygen supply hose.

8

COMPONENT dESCRiPTiON

continued

ITEM

F g

H

DESCRIPTION

Air inlet Fitting

A male DISS or NIST air fitting with one way valve that is used to connect an air supply hose

.

Alarm

An audible alarm that sounds due to an excessive pressure drop or deletion of either gas supply.

Rear Slide Mount with dove tail.

PRE-USE TESTiNg

WARNiNg

Read this User Manual before installing or operating the

Air-Oxygen Blender.

Confirm the concentration of air/oxygen with an Oxygen

Analyzer/Monitor.

CAUTiON

Inspect the Air-Oxygen Blender for visual damage before use, dO NOT USE if damaged.

NOTE: The tests listed below should be performed prior to placing the Blender in service.

Pre-Use Testing consists of:

Alarm Test

• Reverse Gas Flow Procedure

1. Secure the Air-Oxygen Blender to a wall or pole bracket in an upright position.

2. It is recommended to install a condensation trap in the air supply line.

3. Connect the air and oxygen supply lines to the appropriate inlet fittings on the bottom of the Blender.

4. Attach a flowmeter, or other metering device to one of the outlet ports and verify F

I

O

2

range for accuracy with an oxygen analyzer .

9

Primary Outlets Flow capacity:

• High Flow Blender (R203P14 Model) 15 l/min to 120 l/min

• Low Flow Blender (R203P13 Model) 3 l/min to 30 l/min

Auxiliary Outlet:

The auxiliary flow outlet maintains the same flow capacity and F

I O

2

accuracy as the Primary Outlets with Bleed Valve not engaged. When bleed flow is activated, some of the air/ oxygen mixture will vent to atmosphere to maintain F

I O

2

concentration accuracy at the Low Flow settings.

High Flow Blender (R203P14 Model) 15 l/min or less

Low Flow Blender (R203P13 Model) 3 l/min or less

5. Attach a supply line to the outlet port of the flowmeter.

ALARM TEST

1. Connect the Air-Oxygen Blender to air and oxygen sources, pressurize the Blender and turn “ON” the flowmeter.

2. Set Oxygen Concentration dial to 60% F

I O

2.

3. disconnect or turn “OFF” the air supply to the Air-Oxygen Blender.

The Blender should alarm with a loud whistle noise. The whistle indicates the alarm is operating correctly.

4. Reconnect and activate the air supply line to the Blender, the alarm should stop whistling.

5. disconnect or turn “OFF” the oxygen supply line to the Blender.

The whistle indicates the alarm is operating correctly.

6. Reconnect and activate the oxygen supply line to the Blender, the alarm should stop whistling.

7. If alarm fails to function properly, dO NOT USE.

REVERSE gAS FLOW PROCEdURE

1. disconnect the oxygen hose from the gas source. Remove all outlet connections from the Blender to ensure that there is no outlet flow.

2. While gradually increasing the air supply pressure from 30-75 psi

(2.07-5.17 bar) check for leakage past the oxygen inlet check valve.

3. Replace the duckbill Check Valve in the oxygen inlet if leakage is > 100 ml/min. Reference Air-Oxygen Blender

Service Manual (P/N R203M10 ).

4. Repeat steps 1-3 to check for leakage past the air inlet check valve.

10

OPERATiNg iNSTRUCTiONS

CAUTiON

Inspect the Air-Oxygen Blender for visual damage before use, dO NOT USE if damaged.

1. Secure Blender to wall or pole mount bracket.

2. Connect Air and Oxygen supply lines from Blender to wall outlets.

3. Connect flowmeter to Blender outlet.

4. Adjust the Oxygen Concentration dial to the prescribed concentration.

NOTE: The Oxygen Concentration dial does not rotate 360°.

dO NOT force dial less than 21% or over 100% oxygen, this will damage the Blender.

5. Confirm the flow of air and/or oxygen mixture to the patient.

6. Confirm the concentration of air/oxygen with an Oxygen

Analyzer/Monitor. If necessary activate bleed flow valve to maintain F

I O

2

accuracy.

7. To activate the bleed, slide the knurled collar back until it contacts the cover.

8. To deactivate the bleed, pull the collar away from the cover until bleed flow valve is closed.

9. Turn “OFF” gas supplies when Air-Oxygen Blender is not in use.

CLEANiNg

CAUTiON

dO NOT steam autoclave.

dO NOT immerse the Air-Oxygen Blender into any liquid.

dO NOT use any strong solvent or abrasive cleaners.

dO NOT gas sterilize with (EtO) Ethylene Oxide.

dO NOT clean with aromatic hydrocarbons.

1. disconnect all gas connections and equipment before cleaning.

2. Clean exterior surfaces with a cloth dampened with mild detergent and water.

3. Wipe dry with a clean cloth.

11

MAiNTENANCE

The following maintenance on the Air-Oxygen Blender must be performed by a trained service technician:

The alarm should be tested prior to being placed into clinical service and periodically there after.

Every year conduct the Operational Verification Procedure (OVP).

* A detailed description of the OVP tests can be found in the

Blender Service Manual (P/N R203M10), available on the

Internet; www.maxtecinc.com.

Every 2 years the Air-Oxygen Blender should be serviced.

Refer to the Air-Oxygen Blender Service Manual (P/N R203M10) for complete details regarding further maintenance and testing.

TECHNiCAL dESCRiPTiON

For a complete Technical description of the Air-Oxygen Blender and list of Replacement Parts, reference the Air-Oxygen Blender

Service Manual (P/N R203M10) available on the Internet; www.maxtecinc.com.

RETURNS

Returned products require a Returned Material Authorization (RMA) number, contact Maxtec. All returns must be packaged in sealed containers to prevent damage. Maxtec will not be responsible for goods damaged in transit. Refer to Maxtec Return Policy available on the Internet; www.maxtecinc.com.

Manuals available on our Website; www.maxtecinc.com

diSPOSAL iNSTRUCTiONS

This device and its packaging contain no hazardous materials. No special precautions need to be taken when disposing the device and/or its packaging.

Please Recycle

12

TROUBLESHOOTiNg

If the Air-Oxygen Blender fails to function, consult the

Troubleshooting Guide below. If problem cannot be solved by using Troubleshooting Guide, refer to the Air-Oxygen Blender

Service Manual (P/N R203M10) available on the Internet; www.maxtecinc.com or consult your Provider.

Problem

Oxygen concentration discrepancy between Blender setting and

Analyzer/Monitor

(greater than 3%)

Probable Cause

1. High Flow model, flow requirement below 15 l/min.

Low Flow model, flow requirement below 3 l/min.

2. Analyzer/Monitor inaccurate

Remedy

1. Use auxiliary outlet

& engage bleed

2. Recalibrate

Analyzer/Monitor or

Verify with second

Analyzer/Monitor

3. Remove obstruction 3. Low flow bleed obstructed

4. Gas supply contaminated

5. downstream device causing back flow or restricted flow

No flow at

Blender outlets

1. Gas sources turned

“OFF”

2. Gas sources not connected

Alarm sounding 1. difference between

Oxygen and air inlet pressures greater than specified

4. Check gas sources with calibrated

Oxygen Analyzer/

Monitor to confirm

Oxygen is 100% and Air is 21%

5. Isolate Blender.

Check oxygen concentration at

Blender Outlets

1. Turn gas sources

“ON”

2. Connect gas sources

1. Correct pressure difference until

Air and Oxygen pressures are within specification

13

Precision Medical, Inc.

300 Held drive

Northampton, PA 18067 USA

14

LiMiTEd WARRANTy

ANd

LiMiTATiON OF LiABiLiTy

Maxtec warrants that the Blender, (the Product), will be free of defects in workmanship and/or material for the following period:

Two (2) years from shipment

Should any failure to conform to this warranty appear within the applicable period, Maxtec shall, upon written notification thereof and substantiation that the goods have been stored, installed, maintained and operated in accordance with the product instructions and standard industry practice, and that no modifications, substitutions, or alterations have been made to the goods, correct such defect by suitable repair or replacement at its own expense.

ORAL STATEMENTS dO NOT CONSTITUTE WARRANTIES.

The representatives of Maxtec or any retailers are not authorized to make oral warranties about the merchandise described in this contract, and any such statements shall not be relied upon and are not part of the contract for sale. Thus, this writing is a final, complete and exclusive statement of the terms of that contract.

THIS WARRANTY IS EXCLUSIVE ANd IS IN LIEU OF ANY WARRANTY

OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE

OR OTHER WARRANTY OF QUALITY, WHETHER EXPRESS OR

IMPLIEd.

Maxtec shall not under any circumstances be liable for special, incidental or consequential damages including but not limited to lost profits, lost sales, or injury to person or property. Correction of non-conformities as provided above shall constitute fulfillment of all liablities of Maxtec whether based on contract, negligence, strict tort or otherwise. Maxtec reserves the right to discontinue manufacture of any product or change product materials, designs, or specifications without notice.

Maxtec reserves the right to correct clerical or typographical errors without penalty.

507377 Rev1 06/26/12

P rinted in

USA

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