Ohio Medical Corporation MiniOX 1 Operating Manual

Medical Products • Medizinische Produkte • Productos Médicos • Produits Médicaux • Prodotti medici

MiniOX® 1

● Oxygen Analyzer

● Sauerstoff analysator ● Analizador de oxígeno

● Analyseur d’Oxygène ● Analizzatore d’ossigeno

Operating Manual

Customer Service: 1-847-855-0800 Repair: 1-847-855-0800 Fax: 1-608-222-6028

Gebrauch sanweisung

Kundendienst: 1-847-855-0800 Durchwahl 1-847-855-0800 Fax: 1-608-222-6028

Manual de Operacion

Servicio al Cliente 1-847-855-0800 Reparaciones: 1-847-855-0800 Fax: 1-608-222-6028

Manuel d’instructions

Service clientele: 1-847-855-0800 Reparations: 1-847-855-0800 Telefax: 1-608-222-6028

Manuale d’istruzioni

Assistenza al diente: 1-847-855-0800 Manutenzione: 1-847-855-0800 Fax: 1-608-222-6028

FEDERAL (U.S.) LAW RESTRICTS THIS PRODUCT TO SALE BY OR ON THE ORDER OF A PHYSICIAN

NACH US-AMERIKANISCHEM RECHT DARF DIESES PRODUKT NUR VON EINEM ARZT ODER AUF DESSENANORDNUNG HIN VERKAUFT WERDEN

LA LEY FEDERAL (EE.UU.) LIMITA LA VENTA DE ESTE PRODUCTO A LA ORDEN DE UN MÉDICO

LA LOI FEDERALE (DES ETATS-UNIS) N’AUTORISE LA VENTE DE CE PRODUIT QUE PAR OU SUR L’ORDRE D’UNMEDECIN

AI SENSI DELLE LEGGI FEDERALI DEGLI STATI UNITI, IL PRESENTE PRODOTTO VA VENDUTO SOLO DIETROPRESCRIZIONE MEDICA

Manufactured by: Hergestellt von: Fabricado por: Fabrique par: Prodotto da:

Ohio Medical Corporation® | 1111 Lakeside Drive | Gurnee, IL 60031 USA

1-847-855-0800 | www.ohiomedical.com

P/N 711462 (Rev.3) 02/2016

This manual contains instructions in 5 languages. To nd the section written in your preferred

language, please turn to the colored divider indicated below:

Dieses Handbuch enthalt Anweisungen in 5 Sprachen. Zur leichten Aufndung sind die jeweiligen

Sprachenabschnitte mit folgenden Farben gekennzeichnet:

Este manual contiene instrucciones en 5 idiomas. Para encontrar la seccion escrita en el idioma de

su referencia, por favor elija el separador con el color indicado a continuacion:

Ce manuel contient des instructions en 5 langues. Pour trouver la section ecrite dans votre langue préféréé, veuillez vous reporter au diviseur colorié indiqué ci-dessous :

Questo manuale contiene istruzioni in 5 lingue. Per trovare la sezione scritta nella lingua di preferenza, si prega di cercare it divisore in uno dei colori indicati qui sotto:

English: Buff Deutsch: Grun Espanol: Azul Francais: Rouge Italiano: Giallo

P/N 711462 (Rev.3) 02/2016

WARNING

THIS MANUAL MUST BE READ CAREFULLY PRIOR TO THE OPERATION OF THIS DEVICE. THIS DEVICE WILL PERFORM AS DESIGNED ONLY IF USED IN ACCORDANCE WITH THE MANUFACTURER’S INSTRUCTIONS. IMPROPER USE MAY CAUSE THE DEVICE TO FAIL TO PERFORM AS DESIGNED AND MAY CAUSE INJURY TO THE PATIENT AND/OR HEALTHCARE PROFESSIONAL.

The warranties made by Ohio Medical Corporation® with respect to these products are voided if the products are not installed, used and serviced in accordance with the instructions in this manual. Please protect yourself and your patients by following them. We encourage our customers to write or call regarding this equipment prior to use or for any additional information relative to use or repairs.

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

Denition of Warnings and Cautions

WARNING

CAUTION

NOTE:

Statement citing a potential safety hazard and

possible injury to yourself or others.

Statement citing a possibility of damage to the instrument or other property.

Advisory on instrument function.

P/N 711462 (Rev.3) 02/2016

Ohio Medical Corporation

®

Medical Instrument Warranty

This product is sold by Ohio MedicalTM under the warranties set forth in the following paragraphs. Such warranties are extended only with respect to the purchase of this product directly from Ohio Medical or Ohio Medical’s

Authorized Dealers as new merchandise and are extended to the rst Buyer thereof, other than for purpose of

resale.

For a period of twelve (12) months from the date of original delivery to Buyer, to Buyer’s order, or to an Ohio Medical Authorized Dealer, this product, other than its expendable parts, is warranted to be free from functional defects in materials and workmanship and to conform to the description of the product contained in the operation manual and accompanying labels and/or inserts, provided that the same is properly operated under conditions of normal use, that regular periodic maintenance and service is performed and that replacements and repairs are made in accordance with the instructions provided. This same warranty is made for a period of sixty (60) days with respect to the expendable parts. The foregoing warranties shall not apply if the product has been repaired other than by Ohio Medical or in accordance with written instructions provided by Ohio Medical, or altered by

anyone other than Ohio Medical, or if the product has been subject to abuse, misuse, negligence, or accident.

Ohio Medical’s sole and exclusive obligation and Buyer’s sole and exclusive remedy under the above warranties is limited to repairing or replacing, free of charge, at Ohio Medical’s option, a product, which is telephonically

reported to the nearest Ohio Medical Regional Service Ofce and which, if so advised by Ohio Medical, is thereafter returned with a statement of the observed deciency, not later than seven (7) days after the expiration date of the applicable warranty,to the designated Ohio Medical Service Ofce during normal business hours,

transportation charges prepaid, and which, upon Ohio Medical’s examination, is found not to conform with the above warranties. Ohio Medical shall not be otherwise liable for any damages including, but not limited to incidental damages, consequential damages, or special damages.

There are no express or implied warranties which extend beyond the warranties herein above set forth. Ohio

Medical makes no warranty of merchantability or tness for a particular purpose with respect to the product or

parts thereof.

P/N 711462 (Rev.3) 02/2016

X® 1 Oxygen Analyzer Genearl WARNINGS and CAUTIONS

MiniO

General WARNINGS and CAUTIONS

WARNING

1. The MiniOX® 1 Oxygen Analyzer will perform to

specications only if it is used and serviced in

accordance with the manufacturer’s instructions. This

instrument is to be used only by qualied, trained

personnel who have carefully read the operating manual and labels and who have observed the information set forth. If this instrument does not perform as described in this manual, the instrument

must not be used until the condition is rectied.

2. The MiniOX® 1 Oxygen Analyzer must be calibrated prior to each use. A two point calibration check must be performed weekly. (See Section 4, Operation) If the instrument cannot be calibrated, the sensor must be replaced. It the instrument still is unable to be calibrated, the instrument must be serviced.

3. The oxygen sensor has a minimal response to certain gases other than oxygen. Be aware of these gases and their interference levels. See Section 3,

Performance Specications

water for at least 15 minutes, holding eyes open. Call a physician.

6. Ensure a tight t exists between the sensor and the

tee adapter. Ohio Medical tee adapters are engineered

to t securely with Ohio Medical sensors. However,

the sensor retaining strap must be used to prevent accidental separation of sensor and tee adapter.

7. Never use the MiniOX

atmosphere, such as occurs with ammable anesthetics.

Such use could result in ignition of atmosphere.

8. Use of devices generating or emitting electromagnetic radiation near the MiniOX® 1 Oxygen Analyzer may interfere with the proper operation of the product, causing it to fail to perform as designed. Particularly, the electromagnetic radiation from the interfering device may cause the product to display incorrect/ erratic values or to stop operating. Special attention should be paid to the patient if this occurs.

®

1 Oxygen Analyzer in combustible

4. The oxygen sensor is affected by changes in

barometric pressure. Refer to Section 4, Effects of Pressure, for the effects of pressure

5. The sensor is a sealed unit containing a potassium hydroxide electrolyte. If the sensor should develop a leak, discard it immediately. Since the sensor contains caustic material, it must be disposed of in accordance with all applicable regulations in the country in which it is used. Should contact occur with skin or clothing, rinse area immediately with large quantities of water.

In case of eye contact, immediately ush eyes with

CAUTION

1. Remove internal battery if unit is to be non-operational for extended periods of time.

2. Observe polarity when inserting a new battery. Incorrect connection may cause damage to the instrument.

3. The MiniOX® 1 Oxygen Analyzer must never be immersed in any cleaning solution, autoclaved, or exposed to temperatures greater than 70oC.

4. Use only genuine Ohio Medical Corporation replacement parts when performing any maintenance procedures provided in this manual. Failure to do so may seriously impair the instrument’s performance. Repair or alteration of the MiniOX® 1 Oxygen Analyzer beyond the scope of these maintenance instructions

9. Never allow an excess length of cable near the patient’s head or neck, as such could result in strangulation. Secure excess cable to the bed rail or other suitable

object.

10. Never operate the MiniOX® 1 Oxygen Analyzer if it is suspected that water or other liquids have entered into the case. If this occurs, immediately turn the unit OFF and contact your nearest Ohio Medical Corporation Service Center for additional information.

FAILURE TO COMPLY WITH THESE WARNINGS CAN RESULT IN SERIOUS INJURY OR DEATH OF THE PATIENT.

or by anyone other than an authorized Ohio Medical Corporation service person, could cause the product to fail to perform as designed.

5. Improper mounting of the sensor in a breathing circuit may result in inaccurate readings. The sensor MUST

be mounted with the deector pointing downward to

prevent moisture collection on the sensor membrane (see Figure 4-1 in Section 4, Operation). Install the

sensor upstream from the humidier to minimize its

exposure to moisture.

6. Never use a MiniOX® 1 Oxygen Analyzer with a cable that appears worn, cracked, or has damaged insulation

FAILURE TO COMPLY WITH THESE CAUTIONS CAN RESULT IN INSTRUMENT DAMAGE.

APPLICABLE EUROPEAN STANDARDS

1. This device complies with Council Directive 93/42/EEC (Medical Device Directive).

WC-1

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Table of Contents

Table of Contents

Section 1

Introduction ........................................................................................ 1-1

WARNING ......................................................................................................................................1-1

®

Figure 1-1. MiniOX

1 Oxygen Analyzer .......................................................................................1-1

Section 2

Principal of Operation. ...................................................................... 2-1

Section 3

Specications ................................................................................... 3-1

Performance Specications . ........................................................................................................ 3-1

Interferent Gases and Vapors ......................................................................................................3-1

Instrument Replacement Parts ..................................................................................................... 3-1

Accessories .................................................................................................................................3-1

Servicing ....................................................................................................................................... 3-1

Electromagnetic Compatibility (EMC) ........................................................................................... 3-2

WARNING

Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ...........................3-2

Guidance and Manufacturer’s Declaration - Electromagnetic Immunity .............................3-3

Recommended Separation Distances ................................................................................. 3-4

Section 4

Operation ........................................................................................... 4-1

Set-up Procedures ........................................................................................................................ 4-1

Calibration ....................................................................................................................................4-1

Two-point Linearity Check ............................................................................................................4-1

Instrument Operation .................................................................................................................... 4-1

Sensor Operation .........................................................................................................................4-2

Figure 4-1. Sensor Mounting in a Breathing Circuit ............................................................4-2

WARNING ............................................................................................................................4-2

Retaining Strap Installation ........................................................................................................... 4-2

Figure 4-2. Retaining Strap Installation ...............................................................................4-2

TOC-1

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Table of Contents

Effects of Pressure, Humidity, and Temperature ..........................................................................4-2

CAUTION ............................................................................................................................4-2

Effects of Pressure ..............................................................................................................4-2

CAUTION ............................................................................................................................4-3

Effects of Humidity ..............................................................................................................4-3

Effects of Temperature .........................................................................................................4-3

CAUTION .............................................................................................................................4-3

Section 5

Maintenance and Care ...................................................................... 5-1

WARNING ............................................................................................................................5-1

Battery Replacement ................................................................................................................... 5-1

Sensor Replacement .................................................................................................................... 5-1

Cleaning, Disinfection and Sterilization ........................................................................................5-1

CAUTION .............................................................................................................................5-1

Instrument ..................................................................................................................................... 5-1

Sensor and Cable ......................................................................................................................... 5-1

Sensor Deector, Retaining Strap and Tee Adapter .....................................................................5-2

Section 6

Technical Information ....................................................................... 6-1

Technical Description .................................................................................................................... 6-1

Figure 6-1. Block Diagram ........................................................................................................... 6-1

Appendix A

Home Care Kit ...................................................................................A-1

Installation ..................................................................................................................................... A-1

Figure A-1. MiniOX

®

1 Home Care Kit Installation ...................................................................... A-1

TOC-2

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Section 1, Introduction

Section 1

Introduction

The MiniOX® 1 Oxygen Analyzer is designed to provide continuous analyzing or spot checking of oxygen for:

• ventilators

• incubators

• emergency transports

• oxygen tents

• concentrators

• various other respiratory therapy uses

WARNING

This instrument is not equipped with an

alarm, and is therefore not for use in a lifesupport system. Failure to comply with this warning can jeopardize patient well-being.

The MiniOX

®

1 Oxygen Analyzer (Figure 1-1):

• Operates by a single push of a button.

• Calibrates with the turn of a dial.

• Features an easy-to-read digital display

For sensor connection, a tee adapter is provided with each instrument.

The galvanic oxygen sensor measures oxygen concentrations from 0 to 100%. The sensor is maintenance-free and will operate for one year in normal medical use.

WARNING

Users must familiarize themselves with the contents of this manual before using the

MiniOX

®

1 Oxygen Analyzer. Failure to do so can cause misuse of the instrument, and jeopardize patient well-being.

DIGITAL DISPLAY

CALIBRATION DIAL

ON/OFF BUTTON

DEFLECTOR

SENSOR

1-1

Figure 1-1

MiniOX® 1 Oxygen Analyzer

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Section 2, Principal of Operation

Section 2 Principal of Operation

Each MiniOX® 1 Oxygen Analyzer uses a galvanic oxygen sensor which is long-lived and maintenancefree.

The sensor consists of two electrodes:

• a cathode

• an anode

The gold cathode is exposed to the atmosphere

through a uoropolymer membrane. The lead anode is

submersed in a potassium hydroxide solution.

When oxygen diffuses through the membrane, the electrochemical reduction of oxygen on the cathode and the corresponding oxidation of the anode generate an electrical current. The current produced is proportional to the partial pressure of oxygen in the sample atmosphere. The resulting electrical current is

monitored, temperature compensated, and amplied to

drive the display .

The sensor is self-zeroing; when no oxygen is present to be chemically reduced and oxidized, minimal current is produced. Thus, zero percent oxygen is displayed.

2-1

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Section3, Specications

Section 3 Specications

Performance Specications

Range 0-100% O

2

Display Resolution 0.1% O2 increments Linearity Accuracy

Low Battery Indicator

+2% of full scale +2% of full scale “LO BAT” appears on the

display

Warm-Up Time None required

Operating Temperature

Range Storage Temperature range -20

o

0

to 40oC (32o to 104oF)

o

to 55oC (-4o to 131oF)

Humidity 0 to 95% RH Power Requirements One 9-volt alkaline battery Battery Life Approximately 1,400 hours

Dimensions

Instrument 4-5/8” x 2-1/2” x 1-1/2”

Sensor 1-15/16” OD x 1-7/8” long

Cable Length 10 Ft. (3m) fully extended

Sensor Type

Sensor Life

Galvanic fuel sensor 0-100% O

2

Over one year in normal medical conditions

Sensors, as shipped, can be

Shelf Life

stored for a maximum of 6 months without degradation of life

Response

Time measured with

deector and

mounted in a

22 mm tee

adapter @

o

25

C

FLOW

RATE LI-

TERS/MIN.

80% OF

CHANGE

(SECONDS)

2 13 21 5 12 20

10 11 19

97% OF

CHANGE

(SECONDS)

Interferent Gases and Vapors

INTERFERENT

% BY VOL-

UME (DRY

GAS)

INTERFERENT

EQUIVALENT

OF PERCENT O

Helium 80% <0.2% Methoxyurane 4% <2.3% Nitrogen 80% <0.2% Nitrous Oxide 80% <0.8%

Instrument Replacement Parts

DESCRIPTION PART NUMBER

Case Screw 637408 Dovetail Mounting Bracket 474606 40x3/8” stainless stee screw (set

of 4)

450000

Accessories

ITEM PART NUMBER

Alkaline battery, 9-Volt 628817 Coiled Cable 472045 Deector 470687 Home Care Kit (see Appendix A) 474682 Mounting Bracket,Pole 474664 Mounting Bracket, wall 10023945 Operation/Maintenance Manual

CD

600700

Operation Manual (Printed) 711462 Oxygen Sensor 406931 Sensor Retaining Strap 634249 Tee Adapter 473021 Carrying Case 710462 Sleeve Adapter 474667

2

INTERFER-

ENT

%BY

VOLUME

(DRY GAS)

INTERFERENT EQUIVA-

LENT OF PERCENT O

Carbon Dioxide 12% <0.1% Cyclopropane 50% <0.1% Diethyl Ether 20% <1.5% Enurane 4% <0.5% Halothane 5% <0.9%

3-1

2

Inspection and Servicing SVC-101 Calibration SVC-102 Enclosure Replacement SVC-103 Circuit Board Replacement SVC-104 Button and Sensor Jack

Replacement

P/N 711462 (Rev.3) 02/2016

Servicing

SVC-105

MiniOX

®

1 Oxygen Analyzer Section 3, Specications

Electromagnetic Compatibility (EMC)

WARNING

Ensure that the specied electromagnetic environment and separation distances for the MiniOX® 1 Oxygen Analyzer observed according to the tables below. Misuse may result in failure to perform as designed, including incorrect/erratic readings.

Guidance and manufacturer’s declaration - electromagnetic emissions

The MiniO MiniOX

X® 1 is intended for use in the electromagnetic environment specied below. The customer or the user of the

®

1 should ensure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

RF emissions

CISPR 11

Harmonic emissions IEC 61000-3-2

Group 1

Group B

Not applicable Not applicable

The MiniO

X® 1 uses RF energy only for its internal function.

Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

The MiniO

X® 1 is suitable for use in all establishments

including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Voltage uctuations/icker

emissions

Not applicable Not applicable

IEC 61000-3-3

Guidance and manufacturer’s declaration - electromagnetic immunity

The MiniO MiniOX

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

X® 1 is intended for use in the electromagnetic environment specied below. The customer or the user of the

®

1 should ensure that it is used in such an environment.

Immunity test

IEC 60601

test level

+6kV contact +8kV air

+2kV for power supply lines +1kV for input/output lines

+1kV line(s) to line(s) +2kV line(s) to earth

Compliance level

+6kV contact +8kV air

Not Applicable Not Applicable

Electromagnetic environment -

guidance

Floors should be wood, concrete

or ceramic tile. If oors are covered

with synthetic material, the relative humidity should be at least 30%

Voltage dips, short interruptions and voltage variations on power supply

Not Applicable Not Applicable Not Applicable input lines IEC 61000-4-11

Power frequency (50/60 Hz)

magnetic eld

IEC 61000-4-8

NOTE: U

T is the a.c. mains voltage prior to application of the test level.

3 A/m 3 A/m

Power frequency magnetic elds should

be at levels characteristic of a typical location in a typical commercial or hospital environment.

3-2

P/N 711462 (Rev.3) 02/2016

MiniOX

®

The MiniO MiniOX

Immunity

1 Oxygen Analyzer Section 3, Specications

Guidance and manufacturer’s declaration - electromagnetic immunity

X® 1 is intended for use in the electromagnetic environment specied below. The customer or the user of the

®

1 should ensure that it is used in such an environment.

Test

IEC 60601

test level

Compliance

Level

Electromagnetic environment -

guidance

Portable and mobile RF communications equipment should be used no closer to any part of the MiniOX

®

1, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

Conducted RF IEC 61000-4-6

3Vrms 150 kHz to 80 MHz

0.4 Vrms

d = 8.8 SP

d= 1.2 SP 80 MHz to 800 MHz

Radiated RF IEC 61000-4-3

20V/m 80 MHz to 2.5 GHz

3V/m

d = 2.3 SP 800 MHz to 2.5 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m).

Field strengths from xed RF transmitters, as determined

by an electromagnetic site survey,a should be less than the compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and

reection from structures, objects and people.

a. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless) telephones and land

mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with

accuracy. To assess the electromagnetic environment due to xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the MiniO

applicable RF compliance level above, the MiniO

X® 1 should be observed to verify normal operation. If abnormal

performance is observed, additional measures may be necessary, such as reorienting or relocating the MiniO

X® 1 is used exceeds the

X® 1.

b. Over the frequency range 150 kHz to 80 MHz, induced voltages across the sensor cable should be less than 0.4

Vrms, and, over the frequency range 80 MHz to 2.5 GHz, eld strengths should be less than 3 V/m.

3-3

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Section 3, Specications

Recommended separation distances between portable and mobile RF communications equipment

and the MiniOX® 1

The MiniO The customer or the user of the MiniOX

X® 1 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.

®

1 can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment (transmitters) and the MiniOX ed below, according to the maximum output power of the communications equipment.

Rated maximum output

power of transmitter

(W)

150 kHz to 80 MHz

Separation distance according to frequency of transmitter

(m)

80 MHz to 800 MHz

d = 8.8 SP

d = 1.2 SP

800 MHz to 2.5 GHz

0.01 0.88 0.12 0.23

0.1 2.8 0.38 0.73 1 8.8 1.2 2.3

10 28 3.8 7.3

100 88 12 23

®

1 as recommend-

d = 2.3 SP

3-4

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Section 4, Operation

Section 4

Operation

Set-up Procedures

1. Remove the contents from the shipping carton and verify that you have one each of the following items:

®

• MiniOX

• 9-Volt Alkaline battery

• Oxygen Sensorand Deector in Sealed Package

• 10’ Coiled Cable with twist collar

• Sensor Retaining Strap

• MiniOX

• Tee Adapter

2. Remove the sensor form the sealed package and attach it to the coiled cable.

• Firmly press the connector until it snaps into place; tighten the twist collar.

• Insert the opposite end of the coiled cable into

the jack on the side panel of the instrument;

tighten the twist collar.

3. Remove the deector from the package.

• Insert the gasket into the open end of the

deector, ensuring that the gasket is properly seated within the deector.

• Gently screw the deector onto the sensor. For monitoring in a breathing circuit, see

gure 4-1, installing the sensor in a breathing

circuit.

1 Oxygen Analyzer

®

1 Operating/Maintenance CD

2. Place the sensor in a stream of air with a known oxygen concentration or in room air,.

3. Wait for a least one minute, or until the reading has stabilized.

4. If the reading on the display is other than the known

oxygen concentration, adjust the reading using

the calibration dial. Turn clockwise to increase the reading, or counter clockwise to decrease the reading.

5. If the reading cannot be adjusted to the known concentration value, the sensor or instrument is malfunctioning and must be serviced.

Two-Point Linearity Check

The purpose of a two-point check is to determine the linearity of the sensor. Serious deviation from linearity ( + 2%) indicates the sensor is nearing end-of-life. To perform a two-point linearity check:

1. Place the sensor in a stream of a known oxygen concentration between 90-100% until the reading stabilizes.

2. Calibrate to match this concentration.

3. After calibration, measure room air; the reading should be 20.8% +2%. (A +2% linearity variation is allowed for differences due to the method of sample introduction, and the precision of initial setting.) If the variation is greater than 2%, repeat the two-point linearity check. If the variation remains greater then 2%, replace the sensor.

4. Attach the coiled cable to the instrument in the same manner.

5. Remove the four screws holding the back panel in place.

6. Install the battery.

7. Replace the back panel and screws.

8. After installing the sensor, allow to equilibrate prior to calibration.

9. Proceed to Calibration procedures.

Calibration

The best method to calibrate the MiniOX® 1 Oxygen Analyzer is with 100% oxygen. Calibrating with oxygen concentrations less than 100% or with room air is less desirable, but still acceptable.

1. Press the green I/0 button on the front panel to turn on the instrument.

4-1

Instrument Operation

The MiniOX® 1 Oxygen Analyzer has a low battery indicator. When the Low Battery indicator is activated, LO BAT appears on the top left of the display. The instrument functions normally for approximately eight hours; however, replace the battery as soon as possible.

If the sensor becomes disconnected while the instrument is in use, the instrument displays between

-0.1 and +0.2.

The instrument is designed to read in percent from 0 to 100%; however, if incorrectly calibrated, it displays up to

199.

To maximize battery life, turn OFF the MiniOX® 1 Oxygen Analyzer when not in use.

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Section 4, Operation

Sensor Operation

The oxygen sensor has a minimal response to certain gases other than oxygen. Be aware of these gases and their interference levels. See Section 3, Interferent

Gases and Vapors.

2. Firmly insert the sensor into the tee adapter with the

deector pointing downward; ensure a tight t exists.

Figure 4-2

Retaining Strap Installation

3. Install one end of the strap over a post on the tee adapter.

4. Loop the strap around the sensor, inserting the strap

center hole over the sensor cable jack.

5. Install the remaining strap end over the other tee adapter post.

Figure 4-1

Sensor Mounting in a Breathing Circuit.

WARNING

The sensor is a sealed unit containing a

potassium hydroxide electrolyte. If the sensor should develop a leak, discard it immediately. Should contact occur with skin

or clothing, rinse area with large quantities

of water. In case of eye contact, immediately ush eyes with water for at least 15 minutes, holding eyes open. Call a physician.

When using the sensor in a breathing circuit, mount

the sensor with the deector pointing downward (see

Figure 4-1). This prevents moisture from draining on to the sensor membrane (see Section 5, Maintenance and

Care).

WARNING

Ensure a tight t exists between the sensor and the tee adapter. Ohio Medical tee adapters are engineered to t securely with Ohio Medical sensors. However, the sensor retaining strap must be used to prevent accidental separation of the sensor and tee adapter.

6. Attach the coiled cable to the sensor.

7. Tighten the twist collar.

The sensor is now secured in place.

Effects of Pressure, Humidity, and

Temperature

CAUTION

To ensure accurate and reliable oxygen analysis, a thorough understanding of the effects of pressure, humidity, and temperature on the sensor is necessary.

Effects of Pressure

The sensor actually senses partial pressure of oxygen, not percentage. Changes in barometric pressure changes the reading, even if the percent of oxygen in the sample remains constant.

Partial pressure of oxygen (PO2) equals the percent of oxygen (%,O2) times (x) the pressure at which the sample is measured (mmHg-mercury):

PO2 = (%O2) (mmHg)

For example:

Retaining Strap Installation

To install the retaining strap:

1. Remove the coiled cable from the sensor (Figure 4-2).

At sea level the pressure equals 760 mmHg and dry air contains 21 % O2. Therefore;

PO2 = (21%) (760 mmHg)

PO2 = 160 mmHg

4-2

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Section 4, Operation

If the instrument is calibrated to read 21% at 160 mmHg partial pressure, then take the instrument to an area above sea level, where the atmospheric pressure is 700 mmHg; a lower reading is found due to a lower partial pressure.

PO2 = (21%) (700 mmHg)

PO2 = 147 mmHg

The percent reading on the instrument is derived by the following formula:

PO2 Actual = X, 147 mmHg = X or,

PO2 Sea level 21% 167 mmHg 21%

(21%) (147 mmHg) = 19.3%

X =

(160 mmHg)

Therefore, to eliminate error caused by pressure changes, the instrument must be calibrated at the pressure it is to be used.

CAUTION

Do not expose the sensor to pressure outside the range of 600 to 900 mmHg (23.62 to 35.43 inches Hg.) as this can produce instrument errors.

If moisture condenses on the diffusion membrane of the sensor face, the oxygen path is physically blocked and a lower oxygen concentration is indicated. This is typical of all oxygen gas sensors, and is more likely to occur when the sensor is located downstream from a

humidier.

Mount the sensor, when used in a breathing circuit, so

the deector points downward to prevent moisture from

draining onto the diffusion membrane (see Figure 4-1). Also, mount the sensor, when possible, upstream of the

humidier.

Effects of Temperature

Each MiniOX® 1 sensor is desensitized to temperature changes using a thermistor (temperature variable resistor) located within the sensor. Variations in the sensor reading due to temperature changes, are less than 3% when used or calibrated between 0 to 40 degrees centigrade. By using the instrument close to the temperature at which it is calibrated, variations can be minimized.

Operating Temperature Range:

0o to 40oC (32o to 104oF)

Effects of Humidity

The presence of humidity in an oxygen sample decreases the actual concentration of oxygen. Humidity in a sample has the same effects as diluting the sample with another gas.

For example:

If 100% oxygen is saturated with 100% humidity, the actual concentration of oxygen drops from 100% to 96-97%. The instrument indicates this drop in concentration.

CAUTION

Do not use instrument outside operating temperature range.

CAUTION

Do not handle the sensor more than necessary during calibration or use. Body

heat can cause the sensor’s thermistor to change disproportional to the change in gas

sample temperature at the sensing electrode.

This can produce some error, until thermal

equilibrium is restored.

4-3

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Secttion 5, Maintenance and Care

Section 5 Maintenance and Care

WARNING

Use only genuine Ohio Medical Corporation replacement parts when performing any

maintenance procedures included in this

manual. Failure to do so may seriously impair the analyzer’s performance. Repair or alteration of the MiniOX® 1 Oxygen Analyzer beyond the scope of the maintenance instructions or by anyone other than an authorized Ohio Medical Corporation service person could cause the product to fail to perform as designed.

Battery Replacement

The MiniOX® 1 Oxygen Analyzer requires one 9-volt alkaline battery. To replace the battery:

1. Verify the instrument is turned OFF. If it is ON, press the green I/O button on the front panel to turn the instrument OFF.

2. Remove 4 screws from cover to expose sensor.

3. Remove the old sensor from the coiled cable.

4. Attach a new sensor to the coiled cable. Tighten the twist collar.

5. Recalibrate the instrument. (See Section 4,

Calibration)

Cleaning, Disinfection and Sterilization

CAUTION

Never autoclave, immerse, or expose the

MiniOX® 1 Oxygen Analyzer (including

sensor) to high temperatures (>700C). Never expose the device to pressure, irradiation, vacuum, steam, or chemicals (other than alcohol or mild cleaning agents).

Clean the instrument and sensor by wiping with a cloth lightly dampened with Isopropyl Alcohol or mild detergent. Make sure that no moisture seeps into the

instrument case or cable jack port.

Instrument

2. Remove the back panel, which is held in place by four small screws.

3. Remove and discard the old battery; replace with a new battery.

4. Replace the back panel and reinstall the screws.

5. Recalibrate the instrument. (See Section 4,

Calibration)

Sensor Replacement

To ensure safe and effective use of your device, the sensor must be replaced with a MiniOX® sensor as this sensor is manufactured for this instrument. Use of other types of sensors has not been tested and is not endorsed by Ohio Medical Corporation. Use of other sensor types will void your warranty.

There are no serviceable parts in the sensor or cable assemblies; the entire unit must be replaced.

When the MiniOX® 1 Oxygen Analyzer is unable to be calibrated, or gives erratic readings, the sensor must be replaced. To replace the sensor:

1. Verify the instrument is turned OFF. If it is ON, press the green I/O button on the front panel to turn the instrument OFF.

When cleaning or disinfecting the instrument, care must be taken to prevent entry of solutions into the instrument case.

Cleaning

The external surfaces of the unit may be cleaned by wiping them with a cloth moistened with a mild detergent solution.

Disinfection

The external surfaces of the unit may be disinfected by wiping them with a cloth moistened with ethanol or Cidex. The instrument is not designed to withstand the conditions imposed by steam, ethylene oxide or radiation sterilization.

Sensor and Cable

Cleaning

The external surfaces of the oxygen sensor and of the cable may be cleaned by wiping them with a cloth moistened with a mild detergent solution.

Disinfection

The external surfaces of the oxygen sensor housing and of the cable may be disinfected by wiping them with a

5-1

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Section 5, Maintenance and Care

cloth moistened with ethanol or Cidex. The instrument is not designed to withstand the conditions imposed by steam, ethylene oxide or radiation sterilization.

Sensor Deector, Retaining Strap and Tee Adapter

The sensor deector, retaining strap and tee adapter

may be cleaned by wiping them with a cloth moistened with a mild detergent solution. The parts must be thoroughly dry before they are used.

Disinfection

The sensor deector, retaining strap and tee adapter

may be disinfected by washing them with ethanol or Cidex (per manufacturer’s instructions). The parts must be thoroughly dry before they are used.

Sterilization

The sensor deector, retaining strap and tee adapter

may be sterilized using Cidex (per manufacturer’s instructions), steam or ethylene oxide. Due to the varying conditions imposed on materials during sterilization, it is not possible to determine the exact number of times sterilization processes can be carried out. Therefore, the operator must carefully examine the

sensor deector, retaining strap and tee adapter after

sterilization and prior to use to verify that the items are

t for use. The operator must verify that the items are

free from tears and cracks and that the items have not undergone any material changes that may compromise

their tness for use (e.g., brittleness and dimensional

changes). The operator must also examine the items to verify that the items are free of chemical residuals resulting from the sterilization process.

Because of the variability of cleaning, disinfection and sterilization processes, Ohio Medical Corporation

cannot provide specic sterilization instructions, nor can

the sterility of an item be ensured

5-2

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Secttion 6, Tehnical Information

Section 6 Technical Information

Technical Description

The MiniOX® 1 Oxygen Analyzer is designed to provide continuous analyzing or spot checking of oxygen for ventilators, incubators, emergency transports, and various other respiratory therapy uses.

Each MiniOX® 1 Oxygen Analyzer instrument uses an external Galvanic oxygen sensor with its coiled cord to provide an analog voltage signal proportional to the percentage of oxygen being sensed.

The oxygen cell provides an eight (8) to seventeen (17)

millivolt signal (at 20.8% oxygen), which is amplied by a xed gain instrumentation amplier. The output of this amplier is fed into a potentiometer which allows

for manual control by the operator, of the signal fed to the Analog to Digital/Liquid Crystal Driver section. The

operator will manually adjust the control in a known

oxygen concentration so the displayed value matches the ambient oxygen concentration.

Supervisory circuits are present to provide a stable voltage reference for the A/D circuitry, provide battery level monitoring, regulators to keep the DC supply voltages on the devices constant and an ON/OFF switch press monitor circuit.

Figure 6-1

Block Diagram

6-1

P/N 711462 (Rev.3) 02/2016

MiniOX

®

1 Oxygen Analyzer Appendix A, Home Care Kit

Appendix A Home Care Kit

Installation

(Figure A-l)

1. Remove the humidier from the oxygen

concentrator.

2. Thread the universal nipple adapter onto the oxygen concentrator.

3. Place the sleeve adapter on the oxygen sensor.

4. Using the standard oxygen tubing provided, connect the oxygen sensor to the nipple adapter on the oxygen concentrator.

5. Proceed to analyze the oxygen concentration.

(Ensure the ow rate does not exceed four liters-

per-minute).

6. When the oxygen analysis is complete, remove the sampling apparatus and reinstall the

humidier.

OXYGEN TUBING

OXYGEN CONCENTRATOR

OXYGEN ANALYZER

UNIVERSAL NIPPLE ADAPTER

SLEEVE ADAPTER

OXYGEN SENSOR

A-1

MiniOX

Figure A-1

®

1 Home Care Kit Installation

P/N 711462 (Rev.3) 02/2016

WARNUNG

THIS MANUAL MUST BE READ CAREFULLY PRIOR TO THE OPERATION OF THIS DEVICE. THIS DEVICE WILL PERFORM AS DESIGNED ONLY IF USED IN ACCORDANCE WITH THE MANUFACTURER’S INSTRUCTIONS. IMPROPER USE MAY CAUSE THE DEVICE TO FAIL TO PERFORM AS DESIGNED AND MAY CAUSE INJURY TO THE PATIENT AND/OR HEALTHCARE PROFESSIONAL.

The warranties made by Ohio Medical Corporation® with respect to these products are voided if the products are not installed, used and serviced in accordance with the instructions in this manual. Please protect yourself and your patients by following them. We encourage our customers to write or call regarding this equipment prior to use or for any additional information relative to use or repairs.

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

Beschreibung der Warn- und Sicherheitshinweise

WARNUNG

ACHTUNG

HINWEIS

Weist auf potentielle Gefahrensituationen hin, durch die der Bediener sowie andere verletzt werden können.

Weist auf Situationen hin, durch die das Gerät oder andere Gegenstande beschädigt werden können.

Hinweis zum Betrieb des Gerätes.

P/N 711462 (Rev.3) 02/2016

Ohio Medical Corporation

Garantie für medizinische Geräte

This product is sold by Ohio MedicalTM under the warranties set forth in the following paragraphs. Such warranties are extended only with respect to the purchase of this product directly from Ohio Medical or Ohio Medical’s

Authorized Dealers as new merchandise and are extended to the rst Buyer thereof, other than for purpose of

resale.

For a period of twelve (12) months from the date of original delivery to Buyer, to Buyer’s order, or to an Ohio Medical Authorized Dealer, this product, other than its expendable parts, is warranted to be free from functional defects in materials and workmanship and to conform to the description of the product contained in the operation manual and accompanying labels and/or inserts, provided that the same is properly operated under conditions of normal use, that regular periodic maintenance and service is performed and that replacements and repairs are made in accordance with the instructions provided. This same warranty is made for a period of sixty (60) days with respect to the expendable parts. The foregoing warranties shall not apply if the product has been repaired other than by Ohio Medical or in accordance with written instructions provided by Ohio Medical, or altered by

anyone other than Ohio Medical, or if the product has been subject to abuse, misuse, negligence, or accident.

Ohio Medical’s sole and exclusive obligation and Buyer’s sole and exclusive remedy under the above warranties is limited to repairing or replacing, free of charge, at Ohio Medical’s option, a product, which is telephonically

reported to the nearest Ohio Medical Regional Service Ofce and which, if so advised by Ohio Medical, is thereafter returned with a statement of the observed deciency, not later than seven (7) days after the expiration date of the applicable warranty,to the designated Ohio Medical Service Ofce during normal business hours,

transportation charges prepaid, and which, upon Ohio Medical’s examination, is found not to conform with the above warranties. Ohio Medical shall not be otherwise liable for any damages including, but not limited to incidental damages, consequential damages, or special damages.

There are no express or implied warranties which extend beyond the warranties herein above set forth. Ohio

Medical makes no warranty of merchantability or tness for a particular purpose with respect to the product or

parts thereof.

P/N 711462 (Rev.3) 02/2016

MiniOX® 1 Sauerstoff analysator Allgemeine WARN- und SICHERHEITSHINWEISE

Allgemeine WARN- und SICHERHEITSHINWEISE

WARNHINWEIS

1. Der MiniOX® 1 Sauerstoff analysator funktioniert nur dann

spezikationsgemäß, wenn dieser der Anleitung des Herstellers entsprechend eingesetzt und gewartet wird. Dieses

Gerät darf nur von qualiziertem, geschultem Personal

bedient werden, das das Betriebshandbuch und die Etiketten sorgfältig durchgelesen hat, und die darin enthaltenen Informationen beachtet. Funktioniert das Gerät nicht, wie in diesem Handbuch beschrieben, sollte das Gerät erst wieder in Betrieb genommen werden, wenn dieser Zustand behoben wurde.

®

2. Der MiniOX

1 Sauerstoff analysator muss vor jedem Gebr-

auch neu kalibriert werden. Eine Zweipunkt-Kalibrierungsprüfung sollte wöchentlich erfolgen. Siehe Abschnitt 4, Betrieb. Kann das Gerät nicht kalibriert werden, muss der Sensor ersetzt werden. Kann das Gerät noch immer nicht kalibriert werden, muss es gewartet werden.

3. Der Sauerstoff analystor reagiert minimal auf Gase, bei denen es sich nicht um Sauerstoff handelt. Die Anwesenheit solcher Gase und ihre Störwerte sind zu beachten (siehe Abschnitt 3, Leistungsdaten).

4. Der Sauerstoff sensor wird durch Luftdruckschwankungen

beeinusst (siehe Abschnitt 4, Auswirkungen des Luftdrucks.

5. The sensor is a sealed unit containing a potassium hydroxide electrolyte. If the sensor should develop a leak, discard it immediately. Since the sensor contains caustic material, it must be disposed of in accordance with all applicable regulations in the country in which it is used. Should contact occur with skin or clothing, rinse area immediately with large quantities of water.

In case of eye contact, immediately ush eyes with

water for at least 15 minutes, holding eyes open. Call a physician.

6. Überprüfen, ob der Sensor fest auf dem T-Stück sitzt. Die T-Stücke von Ohio Medical Corporation passen genau auf die Ohio Medical Corporation-Sensoren. Dennoch muss zur Vermeidung einer ungewollten Trennung des Sensors vom TStück ein Sicherungsgurt für den Sensor verwendet werden.

®

7. Der MiniOX

1 Sauerstoff analysator soll nicht in Betrieb genommen werden, wenn vermutlich Wasser oder andere Flüssigkeiten in das Gehäuse gelangt sind. Ist dies der Fall, muss die Einheit sofort ausgestellt (OFF) werden. Bitten Sie Ihren zuständigen Ohio Medical Corporation-Kundendienst um weitere Informationen.

®

8. Die Verwendung von Geräten in der Nahe des MiniOX

1 Sauerstoff analysators, die elektromagnetische Strahlung erzeugen oder aussenden, kann die Funktion des Gerätes

sowie die spezikationsgemäße Leistung beeinträchtigen.

Insbesondere kann die elektromagnetische Strahlung des störenden Gerätes eine falsche/sprunghafte Anzeige oder einen totalen Funktionsausfall verursachen. In diesen Fällen muss der Patient genau beobachtet werden.

9. Never allow an excess length of cable near the patient’s head or neck, as such could result in strangulation. Secure

excess cable to the bed rail or other suitable object.

®

10. Never operate the MiniOX

1 Oxygen Analyzer if it is suspected that water or other liquids have entered into the case. If this occurs, immediately turn the unit OFF and contact your nearest Ohio Medical Corporation Service Center for additional information.

FAILURE TO COMPLY WITH THESE WARNINGS CAN RESULT IN SERIOUS INJURY OR DEATH OF THE PATIENT.

1. Den Sensor nur mit Ethylenoxid bei niedriger Temperatur sterilisieren. Siehe Anleitung in Abschnitt 5, Wartung und Pege. Der Sensor darf nie in eine Reinigungslösung eingetaucht, autoklaviert oder hohen Temperaturen ausgesetzt werden.

2. Beim Einsetzen einer neuen Batterie auf die Polarität achten. Bei falschem Anschluss kann das Instrument beschädigt werden.

®

3. The MiniOX

1 Oxygen Analyzer must never be immersed in any cleaning solution, autoclaved, or exposed to temperatures greater than 70oC.

4. Wird eine in diesem Betriebshandbuch beschriebene Wartung durchgeführt, sind nur die Original-Ersatzteile der Ohio

Medical Corporation zu verwenden. Werden rmenfremde

Ersatzteile verwendet, kann dies zu einer schweren Beeinträchtigung der Betriebsleistung des Gerätes führen. Werden Reparaturen oder Änderungen an dem MiniOX analysator vorgenommen, die den Rahmen der in diesem

ANWENDBAR EUROPÄISCHE NORMEN

1. Dieses Gerät erfüllt die EC-Richtlinie 93/42JEEC (Richtlinie für medizinische Geräte)

WC-1

SICHERHEITSHINWEIS

Handbuch enthaltenen Wartungsanweisungen übersteigen oder werden solche Arbeiten nicht von autorisiertem Ohio Medical Corporation-Kundendienstpersonal durchgeführt,

kann dies zu einem nicht-spezikationsgerechten Betrieb des

Produktes führen.

5. Improper mounting of the sensor in a breathing circuit may result in inaccurate readings. The sensor MUST be mounted with the deector pointing downward to prevent moisture collection on the sensor membrane (see Figures 4-1 in Section

4, Operation). Install the sensor upstream from the humidier

to minimize its exposure to moisture.

6. Never use a MiniOX appears worn, cracked, or has damaged insulation

DIE NICHTBEFOLGUNG DIESER SICHERHEITSHINWEISE

®

1 Sauerstoff

P/N 711462 (Rev.3) 02/2016

KANN ZU SCHADEN AM GERÄT FUHREN.

®

1 Oxygen Analyzer with a cable that

MiniOX® 1 Sauerstoff analysator Inhaltsverzeichnis

Inhaltsverzeichnis

Abschnitt 1

Einführung .........................................................................................................1-1

WARNUNG ........................................................................................................................................ 1-1

Abbildung 1-1. MiniOX

Abschnitt 2

Funktion .................................................................................................... 2-1

Abschnitt 3

Technische Daten ..................................................................................... 3-1

Leistungsdaten ........................................................................................................................................... 3-1

Störende Gase und Dämpfe. ...................................................................................................................... 3-1

Ersatzteile für das Gerät ............................................................................................................................. 3-1

®

1 Sauerstoff analysator ................................................................................... 1-1

Zubehör ...................................................................................................................................................... 3-1

Servicing ..................................................................................................................................................... 3-1

Elektromagnetische Kompatibilität (EMC) .............................................................................................. 3-2

WARNUNG ......................................................................................................................................... 3-2

Richtlinie und Erklärung des Herstellers – elektromagnetische Emissionen ......................................... 3-2

Richtlinie und Erklärung des Herstellers – elektromagnetische Immunität ............................................ 3-3

Empfohlene Abstände ........................................................................................................................... 3-5

Abschnitt 4

Betrieb ...................................................................................................... 4-1

Vor Inbetriebnahme .................................................................................................................................... 4-1

Kalibrierung ............................................................................................................................................... 4-1

Zweipunkt-Linearitätsprüfung .................................................................................................................... 4-1

Betrieb des Gerätes .................................................................................................................................. 4-1

Betrieb des Sensors .................................................................................................................................. 4-2

Abbildung 4-1. Montage des Sensors in einem Beatmungskreislauf ................................................. 4-2

WARNUNG ........................................................................................................................................ 4-2

Installation des Sicherungsgurtes ............................................................................................................. 4-2

Abbildung 4-2 Installation des Sicherungsgurtes ............................................................................... 4-2

Auswirkungen von Luftdruck, Luftfeuchtigkeit und Temperatur .................................................................. 4-2

ACHTUNG

Auswirkungen des Luftdrucks ................................................................................................................... 4-2

TOC-1

P/N 711462 (Rev.3) 02/2016

MiniOX® 1 Sauerstoff analysator Inhaltsverzeichnis

ACHTUNG ......................................................................................................................................... 4-3

Auswirkungen von Luftfeuchtigkeit ........................................................................................................ 4-3

Auswirkungen von Temperatur ............................................................................................................... 4-3

ACHTUNG ......................................................................................................................................... 4-3

Abschnitt 5

Wartung und Pege .................................................................................. 5-1

WARNUNG ........................................................................................................................................ 5-1

Austausch der Batterie .............................................................................................................................. 5-1

Austausch des Sensors ............................................................................................................................. 5-1

Reinigung, Desinfektion und Sterilisation .................................................................................................. 5-1

ACHTUNG .......................................................................................................................................... 5-1

Instrument .............................................................................................................................................. 5-1

Sensor und Kabel .................................................................................................................................. 5-1

Sensorablenkung, Haltegurt und T-Adapter ........................................................................................... 5-2

Abschnitt 6

Technische Informationen ....................................................................... 6-1

Technische Beschreibung ......................................................................................................................... 6-1

Abbildung 6-1. Technisches Blockdiagramm ......................................................................................... 6-1

Appendix A

Wartungssatz für den Heimgebrauch ....................................................A-1

Installation ..................................................................................................................................................A-1

Abbildung A-1. MiniOX

®

1 Installation des Wartungssatzes für den Heimgebrauch ..............................A-1

Abschnitt 1 Einführung

TOC-2

P/N 711462 (Rev.3) 02/2016

MiniOX® 1 Sauerstoff analysator Abschnitt 1, Einführung

Der MiniOX® 1 Sauerstoff analysator ist zur ständigen Analyse bzw. zur stichprobenartigen Überprüfung von Sauerstoff bei:

• Beatmungsgeräten

• Brutkästen

• Rettungsfahrzeugen

• Sauerstoffzelten

• Konzentratoren

• und verschiedenen anderen Verwendungszwecken zur Behandlung der Atemwege konzipiert

WARNUNG

Dieses Gerät verfügt über keinen Alarm und ist daher nicht für den Gebrauch an Ufe-Support-Systemen geeignet. Nichtbeachtung dieser Warnung kann den Patienten gefährden.

Der MiniOX

®

1 Sauerstoff analysator (Abbildung 1-1):

• Wird durch einfachen Knopfdruck in Betrieb gesetzt

• Wird durch Drehen des Reglers kalibriert

• Ist mit einer leicht lesbaren Digitalanzeige ausgestattet

Jedem Gerät liegt ein T-Stück für den Anschluss eines Sensors bei. Der galvanische Sauerstoffsensor misst Sauerstoffkonzentrationen von 0 bis 100 %.

Der Sensor braucht nicht gewartet zu werden, seine Einsatzdauer beträgt bei normalem medizinischem Einsatz ein Jahr.

WARNUNG

Vor Inbetriebnahme des MiniOX

®

1 Sauerstoff

analysator sich die Bediener mit dem Inhalt dieses Handbuches vertraut machen. Andernfalls kann es zu unsachgemäßem Einsatz dieses Gerätes und einer Gefährdung des Patienten kommen.

MiniOX

Abbildung 1-1.

®

1 Sauerstoff analysator

P/N 711462 (Rev.3) 02/2016

1-1

MiniOX® 1 Sauerstoff analysator Abschnitt 2, Funktion

Abschnitt 2 Funktion

Jedes MiniOX® 1 Sauerstoff analysator ist mit einem langlebigen, wartungsfreien galvanischen Sauerstoffsensor ausgestattet.

Der Sensor besteht aus zwei Elektroden:

• einer Kathode und

• einer Anode

Die Gold-Kathode ist der Umgebungsluft durch eine Fluorpolymer-Membran ausgesetzt. Die Blei-Anode ist in eine Kaliumhydroxidlösung eingetaucht.

Wenn Sauerstoff durch die Membran diffundiert, erzeugt die elektrochemische Reduktion des Sauerstoffs an der Kathode und die damit verbundene Oxidation an der Anode elektrischen Strom. Der erzeugte Strom ist proportional zum Partialdruck des Sauerstoffs in der Umgebungsluft der Probe. Der daraus resultierende Strom wird überwacht und bei ausgeglichener Tempera-

tur ampliziert, um die Anzeige anzutreiben.

Der Sensor stellt sich automatisch auf Null zurück; ist kein Sauerstoff vorhanden, der chemisch reduziert werden kann bzw. eine Oxidation hervorrufen könnte, wird nur ein Minimum an Strom erzeugt. Auf der Anzeige werden daher Null Prozent Sauerstoff angezeigt.

2-1

P/N 711462 (Rev.3) 02/2016

MiniOX® 1 Sauerstoff analysator Abschnitt 3, Technische Daten

Abschnitt 3 Technische Daten

Leistungsdaten

Bereich 0-100 % 02 Anzeigeauösung in Schritten von 0,1 % O2 Linearität ± 2 % des Skalenendwertes Genauigkeit ± 2 % des Skalenendwertes Anzeige f. leere Batterie “LO BAT” wird angezeigt Aufwärmzeit nicht erforderlich Bereich d. Betriebstemperatur 0 bis 40 °C Bereich d. Lagerungstemperatur -20 bis 55 °C

Luftfeuchtigkeit

Stromanforderungen Eine 9-V Alkalibatterie Lebensdauer d. Batterie Ca. 1400 Stunden

Maße

Kabellänge 3 m, voll ausgezogen

Sensortyp

Gerät 11,7 cm x 6,4 cm x 3,8 cm Sensor 4,9 cm x 4,7 cm

0 bis 95 % relative Luftfeuchtigkeit

Galvanischer Sensor, 0 - 100 % 02

Über ein Jahr unter normalen

Lebensdauer d. Sensors

medizinischen Bedingungen

Sensoren können im Lieferzustand ohne Beeinträchtigung

Lagerungsdauer

FLIESSGEReaktionszeit wird mit einem in einem 22 mm TStück montierten

Deektor bei 25

°C gemessen

STÖRSUB-

STANZ

Kohlendioxid 12% <0.1% Cyclopropan 50% <0.1% Diethylether 20% <1.5% Enuran 4% <0.5%

SCHWIND-

IGKEIT

L/MIN.

2 13 21 5 12 20

10 11 19

Störende Gase und Dämpfe

NACH VOLUMEN% (TROCK-

ENES

ERDGAS)

ihrer Lebensdauer maximal 6 Monate gelagert werden

90% D.

ÄNDERUNG

(SEKUNDEN)

STÖRSUBSTANZ ENT-

SPRICHT O2-PROZENT

97% D.

ÄNDERUNG

(SEKUNDEN)

Störende Gase und Dämpfe

STÖRSUBSTANZ

NACH VOLU-

MEN- %

(TROCKENES

ERDGAS)

STÖRSUBSTANZ

ENTSPRICHT O2-

PROZENT

Methoxyuran 80% <0.2% Stickstoff 4% <2.3% Stickstoffoxid 80% <0.2%

Ersatzteile für das Gerät

BESCHREIBUNG TEILE-NUMMER

Gehäuseschraube 637408 Schwalbenschwanzhalterung 474606

40x3/8” stainless stee screw (set of 4)

Zubehör

ZUBEHÖR TEILE-NUMMER

Alkalibatterie, 9-V 628817 Spiral-Kabel 472045 Deektor 470687 Wartungssatz für den Heimgebrauch

(siehe 4 Anhang A) Halterung, Pole 474664

Mounting Bracket, Wall

Bedienungs-/Wartungshandbuch (CD) 600700 Operation Manual, printed 711462 Sauerstoffsensor 406931 Sicherungsgurt für den Sensor 634249

T-Stück

Carrying Case Sleeve Adapter

450000

474682

10023945

473021 710462 474667

Servicing

Inspection and Servicing Calibration Enclosure Replacement Circuit Board Replacement Button and Sensor Jack

Replacement

SVC-101 SVC-102 SVC-103 SVC-104

SVC-105

3-1

P/N 711462 (Rev.3) 02/2016

MiniOX® 1 Sauerstoff analysator Abschnitt 3, Technische Daten

Elektromagnetische Kompatibilität (EMC)

WARNUNG

Sicherstellen, dass die in den nachstehenden Tabellen angegebenen Abstände für elektromagnetische Umgebungen für den MiniOX® 1 Sauerstoff analysator eingehalten werden. Andernfalls kann es zu Fehlfunktionen bzw. zu falschen/unzuverlässigen Werten kommen.

Richtlinie und Erklärung des Herstellers — elektromagnetischen Emissionen

®

Der MiniOX sehen. Der Kunde oder Benutzer des MiniOX® 1 muss sicherstellen, dass die Einsatzumgebung dieser Vorgabe entspricht.

RF-Emissionen

CISPR 11

RF-Emissionen CISPR 11

Harmonische Emissionen IEC 61000-3-2

1 ist zur Verwendung in der nachstehend angegebenen elektromagnetischen Umgebung vorge-

Emissionstest Compliance Elektromagnetische Umgebung — Richtlinie

®

1 verwendet RF-Energie nur für die internen

Gruppe 1

Der MiniOX

Funktionen. Die RF-Emissionen sind daher äußerst

gering, und es ist unwahrscheinlich, dass sie in benachbarten elektronischen Geräten zu Störungen führen.

®

1 eignet sich zur Verwendung in allen

Klasse B

Der MiniOX

Einrichtungen, einschließlich in Privateinrichtungen und

Einrichtungen, die direkt an das öffentliche Niederspannungsnetz angeschlossen sind, welches Privatgebäude mit Strom versorgt.

Nicht zutreffend Nicht zutreffend

Spannungsschwankungen/ Flicker-Emissionen IEC 61000-3-3

Nicht zutreffend Nicht zutreffend

3-2

P/N 711462 (Rev.3) 02/2016

Ohio Medical Corporation MiniOX 1 Operating Manual

Specifications and Main Features

Frequently Asked Questions

User Manual