Figure 4
operation

DigiOx

Finger Pulse Oximeter

Operation Manual

Important: Do not operate the John Bunn DigiOx Finger Pulse Oximeter without first reading and understanding this manual! Save this manual for future use.

Note: The most current version of this manual can be found online at www.grahamfield.com

JB02008-INS-LAB-RevA09

CONTENTS

 

INTRODUCTION

3

INTENDED USE

3

CONTRAINDICATIONS

3

IMPORTANT SAFETY GUIDELINES - PLEASE

 

READ BEFORE USE

3

OVERVIEW

7

APPEARANCE

7

FEATURES

7

NAME AND MODEL

8

BATTERY INSTALLATION

8

OPERATION INSTRUCTIONS

8

ACCESSORIES (INCLUDED)

11

REPAIR, MAINTENANCE, AND DISPOSAL

11

MAINTENANCE

11

CLEANING AND DISINFECTION

12

DISPOSAL

13

TROUBLESHOOTING

13

SYMBOL KEY

15

TECHNICAL SPECIFICATIONS

16

LIMITED WARRANTY

18

MANUAL DE OPERACIÓN (ESPAÑOL)

21

2

 

INTRODUCTION

Dear User: Please read and understand all instructions before using the John Bunn DigiOx Finger Pulse Oximeter, JB02008.

Intended use

The John Bunn DigiOx Finger Pulse Oximeter is used to measure oxygen saturation (SpO2) and pulse rate in home or clinical settings. It is designed for adult and pediatric patients.

Contraindications

WARNING: The oximeter is not intended for continuous patient monitoring. DO NOT use the oximeter while patient is undergoing MRI or CT scanning.

Important Safety Guidelines - Please Read Before Use The safety statements presented in this chapter refer to the basic safety information that the operator of the John Bunn DigiOx Finger Pulse Oximeter shall pay attention to and abide by. There are additional safety statements in other chapters or sections, which may be the same as or similar to the following, or specific to the operations.

WARNING: Indicates a potential hazard situation or unsafe practice that, if not avoided, could result in death or serious injury.

3

Caution: Indicates a potential hazard or unsafe practice that, if not avoided, could result in minor personal injury or product/property damage.

Note: Provides application recommendations or other useful information to ensure that you get the most from your product.

WARNINGS:

Important! Read and understand this manual before using the oximeter. Do not use this device without proper instruction from a Healthcare Professional. If the oximeter is not properly operated, personal injury and/or damage to the oximeter could result.

If components are damaged or missing, contact your dealer immediately. DO NOT use substitute parts.

Inspect the device before use to ensure that there is no visible damage that may affect patient or user’s safety or measurement performance. Thereafter, inspect the device at least once a week.

GF Health Products, Inc. assumes no responsibility for any damage or injury caused by improper instal- lation or use of this product.

DO NOT open the oximeter housing. It contains no serviceable parts. Service must be performed by trained, authorized personnel only. Otherwise, device failure and health hazard may occur.

4

EXPLOSION HAZARD: Do not use the oximeter in the presence of flammable anesthetics, explosive substances, vapors or liquids.

The oximeter is designed for real-time and

rapid measurement. It is not suitable for long-time continuous patient monitoring. DO NOT apply the sensor to the same finger for more than two hours. If any readings are found to be abnormal, please change the position of the sensor.

The oximeter is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. It is intended as a measuring, not a treatment, device.

Magnetic and electrical fields are capable of interfer- ing with the proper performance of the oximeter. For this reason, ensure that all external devices operated in the vicinity of the oximeter comply with the relevant EMC requirements. Mobile phones, X-ray equipment, and/or MRI devices are a possible source of interfer- ence, as they may emit high levels of electromagnetic radiation. This device complies with IEC60601-1-2.

DO NOT clip this device on edema or tender tissue.

The infrared light emitted from the device (it is invis- ible) is harmful to the eyes. DO NOT stare into the light.

Keep this device out of the reach of children.

5

Cautions

To ensure patient safety, use only parts and ac- cessories specified in this manual.

Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.

OVERVIEW

Appearance

display screen

battery cover

power/display

 

button

 

from any angle. The oximeter features a low voltage indicator, powers off automatically in eight seconds when not in use, and provides approximately 30 hours of use with the use of alkaline batteries.

Name and Model

Name: John Bunn DigiOx Finger Pulse Oximeter

Avoid placing the device on a limb which is wrapped with a cuff for blood pressure measurement or undergo- ing venous infusion.

Ensure that no obstruction (contamination, scar tissue, fingernail polish, acrylic fingernail, etc.) exists at the site where the sensor is placed; such obstruction could

a. Press the Power/Display Button

once more; the screen will

rotate 180° and display as

shown in Figure 6.

b. Press the Power/Display

Button once more; the screen

Figure 6

If the oximeter gets wet, stop operation im- mediately and do not resume operation until it is dry. When it is carried from a cold environment to a warm and/or humid environment, allow it to warm to room temperature before using it.

DO NOT use sharp objects to press the front panel button.

DO NOT sterilize this device. Do not subject this device to irradiation, steam, ethylene oxide, high temperature, or immersion in liquid. Refer to the Repair and Maintenance/Cleaning and Disinfec- tion section of this manual for instructions for cleaning and disinfection.

 

rubber

 

cushion

Figure 1

Figure 2

The DigiOx Finger Pulse Oximeter is shown above.

Features

The John Bunn DigiOx Finger Pulse Oximeter provides a simple way to spot-check patients by combining the sensor and monitor into one integrated, compact, easy-to-use device with single-button operation. The oximeter can accurately measure

Model: JB02008

BATTERY INSTALLATION

1.Refer to Figure 3; insert two AAA batteries, oriented as shown, into the battery compartment.

2.Replace the cover.

Note: Ensure that the batteries are correctly installed. Incorrect installation will prevent the device from operating.

OPERATION INSTRUCTIONS

Notes:

Figure 3

battery installation

affect the signal received by the sensor and result in an incorrect measurement.

Vigorous exercise and electrosurgical device interfer- ence may affect the measuring accuracy.

1.Open the clip as shown in Figure 4.

2.Insert finger, nail up, into

the clip's rubber cushion (ensure that the finger is

correctly positioned), and then gently clip the finger.

3.Press the Power/Display Button to turn the oxim- eter on.

4.The screen will then display the

data as shown in Figure 5. After

 

will rotate 90° and display as

 

shown in Figure 7.

c.

Press the Power/Display Button

 

once more; the screen will

 

rotate 180° and display as

 

shown in Figure 8.

d. Press the Power/Display Button

 

once more; the screen will

 

rotate -90° and also show pulse

 

as a filled wave-form bar graph

 

along bottom of screen, as

 

shown in Figure 9.

e. Press the Power/Display Button

 

once more; the screen will now

Figure 7

Figure 8

Figure 9

oxygen saturation and pulse rate. When a finger is inserted into the sensor’s rubber cushion, and the Power/Display Button is pressed to turn the oximeter

Clean the test finger with isopropyl alcohol before and after each measurement. Ensure that the finger is dry before being inserted into the oximeter.

the values become stable, the

 

user can read the information

Figure 5

on the display screen.

 

show pulse as a hollow wave-

form bar graph along bottom of

screen, as shown in Figure 10.

Figure 10

6

6.To change the oximeter’s display screen bright- ness, press the Power/Display Button for more than one second. There are 10 brightness levels, and the level, from “BR 1” to “BR 10”, will show on the screen during brightness adjustment. The default is level four. Keep the Power/Display Button depressed for as long as it takes to cycle to the desired brightness level.

7.The oximeter will automatically turn off if no finger is sensed for 8 seconds. If the finger is removed and the Power/Display Button is pressed, the oximeter will remain on and change screens, but will display “FINGER OUT”.

ACCESSORIES (INCLUDED)

1One lanyard

2Two AAA alkaline batteries

3One operation manual

REPAIR, MAINTENANCE, AND DISPOSAL

WARNING: DO NOT open the oximeter housing. It contains no serviceable parts. Service must be performed by trained, authorized personnel only. Oth- erwise, device failure and health hazard may occur.

Maintenance

In order to ensure the oximeter's longevity and continued dependable operation, please observe the following maintenance recommendations.

11

TECHNICAL SPECIFICATIONS

on, then the SpO2 value and pulse rate value display on the screen. The oximeter features a bright-color LED screen with adjustable brightness and multi- directional displays that enable the user to read results

7

Change the batteries when the low-voltage indicator displays.

Clean the surface of the device before using: Wipe the device with a clean, soft cloth saturated with a solution of 70% isopropyl alcohol, then let it air dry or wipe it dry. Repeat as necessary.

Take out the batteries if the oximeter will not be used for a long period of time.

Environment (Note:

Operation: 41°F - 104°F

Humidity may shorten

(5°C - 40°C), 15% - 80% RH

the life of the device,

 

or even damage it)

Storage: -4°F - 158°F

 

(-20°C - 70°C), < 93% RH

 

 

Cleaning and Disinfection

1.Do not immerse the device in liquid. Clean the de- vice only by using a surface-clean technique: Wipe with a clean, soft cloth saturated with a solution of 70% isopropyl alcohol.

2.Wipe with a clean, soft cloth saturated with clean water and air dry, or dry with a clean, soft cloth.

Caution: Do not sterilize this device. Do not subject this device to irradiation, steam, ethylene oxide, high temperature, or immersion in liquid.

Caution: Do not use the sensor if it is dam- aged.

12

Do not shake the finger; keep finger motionless during oximeter use.

8

Disposal

Do not treat this device or its batteries as household waste. Separate collection is required.

TROUBLESHOOTING

Problem

Possible Reason

Solution

 

 

 

SpO2 and

Finger

Reposition finger

Pulse Rate

incorrectly

correctly and try again

display

positioned in

 

unstable or

device

 

hard to see

 

 

 

Finger is

Ensure patient remains

 

shaking or

immobile

 

patient is

 

 

moving

 

 

 

 

 

Patient’s SpO2

Remeasure; if

 

value is too low

unsuccessful, yet device

 

to measure

 

is functioning correctly,

 

 

 

 

contact a medical

 

 

professional immediately

 

 

 

 

Excessive

Reduce ambient light

 

ambient light

 

 

 

 

13

LIMITED WARRANTY

5.When the screen displays as shown in Figure 5, pressing the Power/Display Button will change the screen's orientation:

9

Troubleshooting continued

Problem

Possible Reason

Solution

 

 

 

The device

Batteries are

Replace batteries

does not

low

 

turn on

 

 

 

Batteries

Reinstall batteries

 

incorrectly

correctly

 

installed

 

 

 

 

 

The device has

Contact your GF Health

 

malfunctioned

Products, Inc. distributor

 

 

 

The device

The device

Normal

turns off

powers off

 

suddenly

automatically

 

 

8 seconds

 

 

after finger is

 

 

removed

 

 

 

 

 

Batteries are

Replace batteries

 

almost drained

 

 

 

 

Screen

Device

Contact your GF Health

displays

malfunction

Products, Inc. distributor

“Error3”,

 

 

“Error4”,

 

 

“Error6” or

 

 

“Error7”

 

 

 

 

 

 

14

 

f.Press the Power/Display Button once more; the screen will return to the original screen as shown in Figure 5 on previous page.

10

SYMBOL KEY

Symbol

Description

 

 

 

Type BF

 

 

 

Warning: See operation manual

 

 

 

The pulse oxygen saturation

 

 

 

Pulse rate (beats per minute)

 

 

 

Low battery voltage

 

 

SN

Serial number

 

 

Not for continuous monitoring

 

 

15

Display screen

Organic LED Display

 

 

Power supply

Two 1.5V AAA alkaline batteries

requirement

 

 

 

SpO2 Parameter

Measuring range: 0%-100%

Specifications

 

 

Accuracy: 70%-100%, ±3% < 70%,

 

no definition

 

 

Pulse Rate

Measuring range: 30-235 bpm

Parameter

 

Specifications

Accuracy: 30-99bpm, ±2 bpm; 100-

 

235 bpm, ±2%

 

 

Dimensions (L x

2.28" x 1.26" x 1.34" (58 mm x 32 mm

W x H)

x 34 mm)

 

 

Environment

Operation: 41°F - 104°F (5°C - 40°C),

 

15% - 80% RH

 

 

 

Storage: -4°F - 158°F (-20°C - 70°C),

 

< 93% RH

 

 

Net weight with

2 oz. (50g)

batteries

 

 

 

TECHNICAL SPECIFICATIONS continued

 

 

Classification

The type of protection against electric

 

shock: Internally powered equipment

 

 

 

The degree of protection against

 

electric shock: Type BF applied part

 

 

 

The degree of protection against

 

harmful ingress of liquids: Ordinary

 

equipment without protection against

 

ingress of water

 

 

 

Electro-Magnetic Compatibility: Group

 

I, Class B

 

 

GF Health Products, Inc. warrants the John Bunn DigiOx Finger Pulse Oximeter, Model JB02008, for a period of one year against manufacturer's defects. If a product is deemed to be under warranty, GF Health Products, Inc. shall provide, at its option, (1) replace- ment of any defective part or product or (2) a credit of the original selling price made to GF Health Products, Inc.'s initial customer. The warranty does not include any labor charges incurred in replacement part(s) in- stallation or any associated freight or shipping charges to GF Health Products, Inc.

Graham-Field and John Bunn are registered trademarks of GF Health Products, Inc.

Packaging, warranties, products, and specifications are subject to change without notice.

GF Health Products, Inc. is not responsible for typographical errors.

USA Corporate Headquarters:

GF Health Products, Inc.

2935 Northeast Parkway

Atlanta, Georgia 30360

© 2009 GF Health Products, Inc.

Made in China

telephone: 800-347-5678, 770-447-1609

fax: 800-726-0601, 678-291-3232

www.grahamfield.com

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Graham Field JB02008 operation manual Intended use, Contraindications, Do not clip this device on edema or tender tissue