John bunn Jb02017 User manual

OXYREAD

FINGERTIP

PULSE OXIMETER

MODEL JB02017

OPERATOR MANUAL

GENERAL DESCRIPTION

The John Bunn JB02017 OxyRead Fingertip Pulse Oximeter

provides a simple way to spot-check users by combining the

sensor and monitor into one integrated, compact, easy to use

device. The oximeter measures pulse oxygen saturation (SpO

)

value, pulse rate value, and pulse strength. When a nger

is inserted into the sensor’s rubber cushion, the SpO

value

automatically displays. The pulse bar graph displays the user’s

pulse beat, and the bar graph’s height shows pulse strength.

The oximeter, which is powered by two AAA batteries, features

a low-battery indicator and powers off automatically in eight

seconds when not in use.

Product Accessories (Included)

1. One lanyard

2. Two AAA batteries

3. One protective cover

4. One operator manual

Principle of Measurement

Two beams of different wavelength (660 nm glow and 940 nm

near infrared light) are focused onto a human nail tip through a

clamping nger-type sensor. A measured signal obtained by a

photosensitive element, through processes of electronic circuits

and microprocessor, will be shown on the oximeter’s display.

Principle of Operation Diagram

See illustration and descriptions below.

1 Red and Infrared Emission Tube

2 Red and Infrared Receipt Tube

INTENDED USE

The intended use of the OxyRead Fingertip Pulse Oximeter

is the measurement and display of the functional oxygen

saturation of arterial hemoglobin (SpO2) and pulse rate (PR) of

adults and pediatric users in hospital, ambulatory, home, and

EMS (Emergency Medical Service) environments. The Pulse

Oximeter is intended for spot-checking these levels.

Contraindications (

WARNINGS):

•If you do not understand any part of these instructions,

contact a healthcare professional for direction in the use

of this product.

•This device is not intended for continuous monitoring.

•Do not use this device in an explosive atmosphere.

•Do not use this device in an MRI or CT environment.

INACCURATE MEASUREMENTS MAY BE CAUSED BY THE FOLLOWING:

•Autoclaving, ethylene oxide sterilizing, or immersing the

device in liquid

•Signicantlevelsofdysfunctionalhemoglobins(suchas

carbonxy-hemoglobinormethemoglobin)

•Intravascular dyes such as indocyanine green or

methyleneblue

•

Highambientlight—shieldthesensorarea(witha

surgicaltowel,ordirectsunlight,forexample)ifnecessary

•Excessive user movement

•High-frequencyelectrosurgicalinterference

•Venous pulsations

•Placementofasensoronanextremitywithablood

pressure cuff, arterial catheter, or intravascular line

•User hypotension, severe vasoconstriction, severe

anemia, or hypothermia

•User cardiac arrest or shock

•

Improperngerplacement,e.g.ngernailnotfacingupward

•Fingernailpolishorfalsengernails.

SAFETY — PRECAUTIONS FOR USE

WARNING: Indicates a potential hazard situation or

unsafe practice that, if not avoided, could result in death

orseriousinjury.WARNINGstatementsfollow:

Before use, carefully read the manual.

The pulse oximeter has no alarms. Do not use the pulse

oximeterinsituationswherealarmsarerequired.Itisnot

intended for continuous monitoring.

The pulse oximeter is intended only as an adjunct in user

assessment.Itmustbeusedinconjunctionwithother

methods of assessing clinical signs and symptoms.

CAUTION: Indicates a potential hazard or unsafe

practice that, if not avoided, could result in moderate or

minorpersonalinjury.CAUTIONstatementsfollow:

Check the pulse oximeter sensor application site

frequently to determine the positioning of the sensor and

circulation and skin sensitivity of the user.

Donotstretchtheadhesivetapewhileapplyingthepulse

oximeter sensor. This may cause inaccurate readings or

skinblisters.

Prolonged use or the user’s condition may require

changing the sensor site periodically. Change sensor site

and check skin integrity, circulatory status, and correct

alignment at least every 4 hours.

NoticeforCaliforniaCustomers-CaliforniaProposition

65WARNING:Thisproductcontainsachemicalknownto

the State of California to cause cancer and reproductive or

developmental harm.

sNOTICE: Indicates a potential hazard or unsafe practice

that, if not avoided, could result in product/property

damage.

SETUP

Battery Installation

1. Open battery compartment cover.

Install two AAA batteries in battery

compartment, ensuring polarities are correct.

3. Close battery compartment cover: Push cover horizontally

along the arrow as shown at right.

sNOTICE:Ensurebatterypolarities are correct, or the

devicecouldbedamaged.

Lanyard Installation

Thread the thinner end of the lanyard through the oximeter loop.

2. Thread the thicker end of the lanyard through the threaded

end, then pull it tightly.

OPERATION INSTRUCTIONS

1. Use isopropyl alcohol to clean the test nger and the rubber

inside the oximeter that touches the nger.

2. Place clamp over ngernail as shown

at right; insert nger, ngernailupas

shown.

3. Press button on front panel once. User’sngerandbody

must remain still during measurement.

4. See display: the SpO2value automatically displays, the

pulse bar graph displays the pulse rate, and the bar graph’s

height shows the pulse strength.

MAINTENANCE AND STORAGE

sNOTICE: Thisdevicecontainsnoserviceableparts.Do

notdisassemble.

sNOTICE: Removethebatteriesiftheoximeterwillnotbe

used for a long period of time.

sNOTICE: Donotautoclave,sterilizewithethyleneoxide,

or immerse the device in liquid.

sNOTICE: See SPECIFICATIONS/Environmental

Requirements for operation and storage requirements.

Awetambiencecoulddamagethisproductandshorten

its lifetime.

sNOTICE: Recycle or dispose of this device and its used

batteriesinobservanceoflocalregulations.

Info:Useisopropylalcoholtocleantherubber(inside

theoximeter,thattouchesthenger)andthetestnger

beforeandaftereachtest.Therubberinsidetheoximeter

ismedicalrubber,whichhasnotoxins,andisnotharmful

to the skin.

Info:

Replacethebatterieswhenlowbatteryindicator

illuminates.

SPECIFICATIONS

Display Type LED (Light Emitting Diode)

SpO2Measurement

range

70-99%

Accuracy 80%-99%: ±2%

70%-79%: ±3%

≤69% : no definition

Pulse Rate Measurement

range

30-235 BPM

Accuracy 30~99 BPM: ±2 BPM

100~235 BPM: ±2%

Pulse Intensity Bargraph Indicator

Power Requirement Two AAA alkaline Batteries

Power Consumption <40 mA

Low Power Indicator

Battery Life ~ 30 hours of continuous operation

Dimension

(L x W x H)

2.20"~ 2.44" x 1.26"~ 1.50"x 1.34"~ 1.50"

(56 mm ~ 62 mm x 32 mm ~ 38 mm x 34 mm ~ 38 mm)

Weight 1.59 oz ~ 2.12 oz (0.10 lb ~ 0.13 lb) (45 g ~ 60 g)

including two AAA batteries

Environmental

Requirements

Temperature Operation 41°F ~ 104°F

(5°C ~ 40°C)

Storage -13°F ~ 158°F

(-25°C ~ 70°C)

Humidity

(non-condensing)

Operation ≤80% RH

Storage ≤93% RH

Interference

Resistance Capacity

against Ambient Light

Device works normally when mixed noise produced

by BIO-TEK INDEX Pulse Oximeter tester

DECLARATION

This product’s EMC complies with IEC60601-1-2 standard.

The materials with which the user can come into contact have

no toxicity, no action on tissues, and comply with ISO10993-1,

ISO10993-5 and ISO10993-10.

GUIDANCE AND MANUFACTURER’S DECLARATION:

ELECTROMAGNETIC EMISSIONS FOR ALL EQUIPMENT

AND SYSTEMS

Guidance and manufacturer’s declaration – electromagnetic emission

The Pulse Oximeter is intended for use in the electromagnetic

environment specified below. The customer or the user of the Pulse

Oximeter should assure that it is used in such an environment.

Emission Test

Compliance

Electromagnetic environment – guidance

RF emission

CISPR 11

Group 1

The Pulse Oximeter 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.

RF emission

CISPR 11

Class B

The Pulse Oximeter 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.

TROUBLESHOOTING

Problem Possible reason Solution

SpO2or PR

cannot be

displayed

normally

1. User's finger is incorrectly

inserted

2. User’s Oxyhemoglobin

value is too low to be

measured

1. Reinsert user's finger

Attempt several times to

obtain a reading; If sure that

no problem exists, obtain

further clinical examination

SpO2or PR

display is

unstable

1. Finger may not be

inserted deeply enough

2. Finger trembling or user

moving

1. Reinsert finger

2. Ask user to remain still

Troubleshooting continued

Problem Possible reason Solution

Oximeter

cannot be

powered on

1. Battery power may be

inadequate or batteries

may not be installed

2. Batteries may be installed

incorrectly

Oximeter may be damaged

1. Replace batteries

2. Reinstall batteries

3. Contact GF distributor

Indicator

lamps are

suddenly

off

1. Device automatically

powers off when no signal

is detected for longer than

8 seconds

2. Batteries too weak to

power device

1. Normal

2. Replace the batteries

“Error3” or

“Error4”

displays

1. Low power

2. Receiving tube and/or

connector may be

shielded or damaged

3. Mechanical misplace for

receive-emission tube

4. Amp circuit malfunction

1. Replace batteries

2. Contact GF distributor

3. Contact GF distributor

4. Contact GF distributor

“Error7”

displays

1. Low power

2. Emission diode damaged

3. Current control circuit

malfunction

1. Replace batteries

2. Contact GF distributor

3. Contact GF distributor

SYMBOL DEFINITIONS

Symbol Definition Symbol Definition

Type BF applied part Low power indicator

Follow instructions for use

No SpO2Alarm

﹪ SpO2Oxygen saturation Power switch

❤

BPM Heart rate (BPM) SN Serial Number

Manufacturer

Info: The illustration used in this manual may differ slightly

from the appearance of the actual product.

LIMITED WARRANTY

SCOPE OF WARRANTY

GF Health Products, Inc. (“GF”) warrants to the Original Purchaser only that it will replace or repair components, at GF’s sole discretion, that are defective

in material or workmanship under normal use and service. All warranties are conditioned upon the proper use of the products strictly in accordance

with good commercial practice and applicable GF instructions and manuals, including p roper use and maintenance. To the extent that a component is

warranted by a third party, GF conveys all of its rights under that warranty to the original purchaser, to the extent permitted. Original Purchaser is one who

purchases this product new and unused from GF or a GF Distributor.

This limited warranty shall only apply to defects that are reported within the applicable warranty period and which, upon examination by GF or its

authorized representative, prove to be a warranty item. This limited warranty is not transferable.Within the guidelines set forth in this document, this

product is warranted for one (1) year. The applicable warranty period shall commence from date of shipment to the Original Purchaser, unless there is an

expiration date on the component in which case the warranty shall expire on the earlier of warranty period or the expiration date.

OBTAINING WARRANTY SERVICE

This limited warranty shall only apply to defects that are reported to the Distributor from whom the Customer purchased the product within the applicable

warranty period. If there is not a Distributor, you must contact GF directly by calling 1-770-368-4700, sending a fax request to 1-770-368-2386, or by

e-mailing a request to [email protected]. Specific directions will be provided by the Customer Service Representative. Failure to abide by the specific

directions will result in denial of the warranty claim.

EXCLUSIONS

The warranty does not cover and GF shall not be liable for the following:

1) Defects, damage, or other conditions caused, in whole or in part, by misuse, abuse, negligence, alteration, accident, freight damage, tampering or

failure to seek and obtain repair or replacement in a timely manner;

2) Products which are not installed, used, or properly cleaned and maintained as required in the official manual for the applicable product;

3) Products considered to be of a non-durable nature including, but not limited to: casters, filters, fuses, gaskets, lubricants, and charts;

4) Accessories or parts not provided by GF;

5) Charges by anyone for adjustments, repairs, replacement parts, installation or other work performed upon or in connection with such products which

are not expressly authorized in writing, in advance, by GF;

6) Any labor or shipping charges incurred in the replacement part installation or repair;

7) Costs and expenses of regular maintenance and cleaning; and

Representations and warranties made by any person or entity other than GF.

ENTIRE WARRANTY, EXCLUSIVE REMEDY AND CONSEQUENTIAL DAMAGES DISCLAIMER

THIS WARRANTY IS GF’S ONLY WARRANTY AND IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED. GF MAKES NO IMPLIED

WARRANTIES OF ANY KIND INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

IF ANY MODEL OR SAMPLE WAS SHOWN TO THE CUSTOMER, SUCH MODEL OR SAMPLE WAS USED MERELY TO ILLUSTRATE THE GENERAL

TYPE AND QUALITY OF THE PRODUCT AND NOT TO REPRESENT THAT THE PRODUCT WOULD NECESSARILY CONFORM TO THE MODEL OR

SAMPLE IN ALL RESPECTS.

THIS WARRANTY IS LIMITED TO THE REPAIR OR REPLACEMENT OF THE DEFECTIVE PARTS. GF SHALL NOT BE LIABLE FOR AND HEREBY

DISCLAIMS ANY DIRECT, SPECIAL, INDIRECT, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED

TO: DAMAGES FOR LOSS OF PROFITS OR INCOME, LOSS OF USE, DOWNTIME, COVER, OR EMPLOYEE OR INDEPENDENT CONTRACTOR

WAGES, PAYMENTS AND BENEFITS.

The warranties contained herein contain all the representations and warranties with respect to the subject matter of this document, and supersede all prior

negotiations, agreements and understandings with respect thereto. The recipient of this document hereby acknowledges and represents that it has not

relied on any representation, assertion, guarantee, warranty, collateral contract or other assurance, except those set out in this document. Some states do

not allow the exclusion of certain remedies; in those instances that state’s law will control. This warranty gives you specific legal rights, and you may also

have other rights which vary from state to state.

For additional information on this product or this warranty, please contact a GF Customer Service Representative.

NOTES:

1) Additional terms and conditions may apply.

2) Freight claims must be notated on the appropriate shipping documents and must be made with immediacy. International, federal and state regulations

govern specific requirements for freight claims. Failure to abide by those regulations may result in a denial of the freight claim. GF will assist you in filing

the freight claim.