Graham Field John Bunn JB02020 User manual

JB 0 2020-INS-LAB-RevA20
JB02020 Fingertip Oximeter
User Manual
Important: Do not operate the Finger Pulse
Oximeter without rst reading and understanding
this manual! Save this manual for future use.
Info: The most current version of this manual can be found
online at www.grahamfield.com.

JB02020-INS-LAB-RevA20 • Fingertip Oximeter User Manual 2
CONTENTS
1 INTRODUCTION .................................................................... 3
INTENDED USE..................................................................... 3
CONTRAINDICATIONS........................................................... 3
2 IMPORTANT SAFETY GUIDELINES—READ BEFORE USE ...... 4
WARNINGS........................................................................... 5
NOTICES............................................................................... 7
3 PRODUCT DESCRIPTION AND FEATURES ............................. 8
CONTENTS — PACKING LIST ............................................... 8
JB02020 FINGER PULSE OXIMETER FEATURES ................... 9
DECLARATION OF CONFORMITY......................................... 10
4 SETUP—BATTERY INSTALLATION...................................... 11
5 OPERATION INSTRUCTIONS ............................................... 12
CORRECT MEASUREMENT PROCEDURES........................... 13
6 SERVICE LIFE, REPAIR, MAINTENANCE, AND DISPOSAL..... 14
EXPECTED SERVICE LIFE.................................................... 14
REPAIR ............................................................................... 14
MAINTENANCE................................................................... 14
STORAGE............................................................................ 15
DISPOSAL........................................................................... 15
7 TROUBLESHOOTING .......................................................... 16
8 TECHNICAL SPECIFICATIONS ............................................. 17
9 SYMBOL KEY ..................................................................... 20
10 LIMITED WARRANTY .......................................................... 21
APPENDIX I EMC ..................................................................... 24

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1 INTRODUCTION
Read and understand all instructions before using the John
Bunn JB02020 Finger Pulse Oximeter.
Intended Use
This Fingertip Oximeter is intended to measure the pulse rate
and functional oxygen saturation (SpO2) through a patient’s
finger. It is applicable for spot-checking SpO2and pulse rate of
adult and pediatric patients in homes and medical clinics.
Contraindications
WARNING: The oximeter is not intended for continuous
patient monitoring. DO NOT use the oximeter while patient
is undergoing MRI or CT scanning. This device is NOT
MRI Compatible.

JB02020-INS-LAB-RevA20 • Fingertip Oximeter User Manual 4
2 IMPORTANT SAFETY GUIDELINES—READ BEFORE USE
The safety statements presented in this chapter refer to
the basic safety information that the operator of the 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.
CAUTION: Indicates a potential hazard or unsafe practice
that, if not avoided, could result in minor personal injury.
s NOTICE: Indicates a potential hazard or unsafe practice
that, if not avoided, could result in product or property
damage.
Info: Provides application recommendations or other useful
information to ensure that you get the most from your product.

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WARNINGS
WARNING: 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.
WARNING: EXPLOSION HAZARD: Do not use the oximeter
in the presence of flammable anesthetics, explosive
substances, vapors or liquids.
WARNING: Inspect the device before use to ensure that
there is no visible damage that may affect patient or user’s
safety or measurement performance. If there is visible
damage, do not use the device. Thereafter, inspect the
device at least once a week.
WARNING: 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.
WARNING: 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.
WARNING: DO NOT clip this device on edema or tender
tissue.

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WARNING: 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.
WARNING: The infrared light emitted from the device (it is
invisible) is harmful to the eyes. DO NOT stare into the light.
WARNING: Keep this device out of the reach of children.
WARNING: Magnetic and electrical fields are capable of
interfering 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 interference, as they
may emit high levels of electromagnetic radiation. This
device complies with IEC 60601-1-2.
WARNING: Use only parts and accessories specified in this
manual.
WARNING: If components are damaged or missing, contact
your distributor immediately. DO NOT use substitute parts.
WARNING: GF Health Products, Inc. assumes no
responsibility for any damage or injury caused by improper
installation or use of this product.
WARNING: WARNING: Cancer and Reproductive Harm -
www.p65warnings.ca.gov.

JB02020-INS-LAB-RevA20 • Fingertip Oximeter User Manual 7
Notices
s NOTICE: Keep the Oximeter away from dust, lint,
vibration, corrosive substances, explosive materials, high
temperature, sunlight, and moisture.
s NOTICE: If the Oximeter gets wet, stop using it and do not
resume operation until it is dry and checked for correct
operation.
s NOTICE: When the oximeter is taken from a cold
environment to a warm and humid environment, do not
use it immediately — allow at least fifteen minutes for the
Oximeter to reach ambient temperature.
s NOTICE: DO NOT operate the button on the front panel
with sharp materials or sharp point.
s NOTICE: DO NOT use high temperature or high pressure
steam disinfection on the Oximeter. Refer to Chapter 7 for
instructions regarding cleaning and disinfection.
s NOTICE: The equipment is IP22 with protection against
harmful solid foreign objects and ingress of liquid: i.e., the
equipment is protected against solid foreign objects of
12.5mm in size and greater, and protected against vertically
falling water drops when enclosure is tilted up to 15°.

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3 PRODUCT DESCRIPTION AND FEATURES
display screen
display key
rubber cushion
JB02020 Finger Pulse Oximeter
Contents — Packing List
1) One JB02020 Fingertip Oximeter
2) One Lanyard
3) Two AAA Alkaline Batteries
4) One User Manual

JB02020-INS-LAB-RevA20 • Fingertip Oximeter User Manual 9
JB02020 Finger Pulse Oximeter Features
• S-L-M Display type
• Displays SpO2, PR, PI
• Auto on/off
• PR and PI shifts
• Pulse bar
• Over-limits indicator
• Two-direction display

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Declaration of Conformity
This device complies with the following standards:
IEC 60601-1: 2005 Medical electrical equipment-Part 1: General
requirements for basic safety and essential performance;
BS/EN/ISO 9919:2009 or the equivalent ISO 80601-2-61:2011 -
Medical electrical equipment - Part 2-61: Particular
requirements for basic safety and essential performance of
pulse Oximeter equipment.
And it also follows the provisions of the council directive MDD
93/42/EEC.

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4 SETUP—BATTERY INSTALLATION
Battery Installation
1. Slide battery cover open as shown above.
2. Install two AAA size batteries into the battery compartment
as shown above. Note polarity markings and ensure
batteries are correctly installed, or device may not
function.
3. Replace the cover.
s NOTICE: Change the batteries when the low-voltage
indicator illuminates.
s NOTICE: Remove the batteries if the device will not being
used for more than seven days to prevent potential damage
from battery leakage.

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5 OPERATION INSTRUCTIONS
Before use: surface-clean sensor with a soft cloth damped with
a solution of 75% isopropyl alcohol, then surface-clean with a
cloth damped ONLY with clean water and dry with a clean, soft
cloth.
Open Oximeter and Position Finger
1. Open clip, place finger between the rubber cushions as
shown above, and gently close clip on finger.
2. After two seconds, the Oximeter will automatically power on
and begin to measure.
3. The display screen is shown above; short press the display
key to shift the display direction; long press the display key to
see the measured PI value.
Info: During measurement, if SpO2or Pulse Rate value
exceeds the preset limit (see Preset Over-limits in TECHNICAL
SPECIFICATIONS section), that measured value which exceeds
limit will flash on the screen.

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Correct Measurement Procedures
• Ensure finger is correctly positioned in sensor.
• Relax; do not move; do not move finger during measurement.
• Do not place wet finger in sensor.
• Do not place the device on a limb with with a blood pressure
cuff applied.
• Do not place the device on a limb receiving venous infusion.
• Nail polish or paint may affect the measuring accuracy, and
too long a fingernail on measurement finger may cause
failure of measurement or inaccurate result.
• Vigorous exercise and electrosurgical device interference
may affect the measuring accuracy.
• Existence of high intensive light sources, such as
fluorescence light, ruby lamp, infrared heater or strong
sunshine, etc. may cause inaccuracy of measurement result.
Place an opaque cover on the sensor or change location.
• If the first measurement displays irregular waveform, then
the measurement is probably inaccurate; wait or restart.

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6 SERVICE LIFE, REPAIR, MAINTENANCE, AND DISPOSAL
Expected Service Life
Info: The expected service life (not warranty) of this device is
five years.
Repair
WARNING: DO NOT open the oximeter housing. It contains
no serviceable parts. Service must be performed by
trained, authorized personnel only, or device failure and
health hazard could occur.
Maintenance
s NOTICE: In order to ensure a long service life, adhere to the
following maintenance instructions.
• Change batteries when low-voltage indicator illuminates.
Cleaning / Disinfection
s NOTICE: DO NOT use high pressure, high temperature,
irradiation steam, or ethylene oxide sterilization on the
device.
Surface-clean sensor with a soft cloth damped with a solution of
75% isopropyl alcohol, then surface-clean with a cloth damped
ONLY with clean water, and dry with a clean, soft cloth.

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Storage
• Remove batteries if the Oximeter will not be used for more
than seven days.
• Store the device in a dry, dust-free environment free from
high temperature, sunlight, and dust. Humidity may damage
or reduce the life of the device. When the oximeter is taken
from a cold environment to a warm and humid environment,
do not use it immediately — allow at least fifteen minutes
for the Oximeter to reach ambient temperature.
Disposal
s NOTICE: Do not treat this device as household waste;
separate collection is required. Dispose of this device and
its batteries in accordance with local laws and regulations.
• See TECHNICAL SPECIFICATIONS section for recommended
operation and storage environment of the device.

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7 TROUBLESHOOTING
Problem Solution
SpO2/ Pulse Rate
display unstable
Position the finger carefully as described in
OPERATION INSTRUCTIONS; try again
Unable to turn on device;
no display
1. Patient must relax as described in
OPERATION INSTRUCTIONS; try again
2. Change batteries
Display direction doesn’t
change
Shake Oximeter gently; if problem persists,
orientation-sensor may not be not working
properly
If above problem persists, contact the distributor

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8 TECHNICAL SPECIFICATIONS
SpO2
Measurement
Transducer Dual-wavelength
LED sensor with
wavelength
Red light 663 nm, Infrared
light: 890 nm.
Maximal average optical
output power
≤2mW
SpO2display range 35%~100%
SpO2measuring accuracy ≤ 2% for SpO2
range from 70%
to 100%
Pulse Rate
measurement
PR display range 30bpm~240bpm
PR measuring accuracy ±2bpm or ±2%
(whichever is
greater)
Perfusion Index
(PI) Display range
0%~20%
Preset over-limits SpO2low limit 90%
Pulse
Rate
Limit
High 120bpm
Low 50bpm

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TECHNICAL SPECIFICATIONS CONTINUED
Visual alert
function
When measuring, if SpO2value or pulse rate value
exceeds the preset limit, the measured value
which exceeds limit will flash on the screen.
Power supply
requirement
Two AAA alkaline batteries
Supply voltage 3.0VDC
Operating current ≤40mA
Environmental
Conditions
Temperature Operating 41°F ~ 104°F
(5°C ~ 40°C)
Storage -4ºF ~ 140ºF
(-20ºC ~ 60ºC)
Humidity Operating 30% ~ 80%
Storage 10% ~ 95%
Atmospheric
pressure
Operating 70kPa ~ 106kPa
Storage 50kPa ~ 107.4kPa
Low Perfusion
Performance
The accuracy of SpO2and PR measurement still
meet the precision described above when the
modulation amplitude is as low as 0.6%.
Ambient Light
Interference
The difference between the SpO2value measured
in the condition of indoor natural light and that of
darkroom is less than ±1%.

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TECHNICAL SPECIFICATIONS CONTINUED
Dimensions 56 mm (L) × 34 mm (W) × 30 mm (H)
Net Weight Approximately 60g
Classification Type of protection against
electric shock
Internally
powered
equipment.
Degree of protection
against electric shock
Type BF applied
parts.
Degree of protection
against harmful solid
foreign objects and ingress
of liquid
IP22 with
protection against
harmful solid
foreign objects
and ingress of
liquid (equipment
is protected
against solid
foreign objects
≥ 12.5mm, and
vertically falling
water drops when
enclosure tilted
< 15°).
Electro-Magnetic
Compatibility
Group I, Class B

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9 SYMBOL KEY
PI
Pulse Oxygen Saturaon
Pulse Rate (Beats per Minute)
Perfusion Index (%)
Pulse Strength Bar Graph
Low Baery Voltage
CE Mark
Serial Number
Date of Manufacture
Authorized Representave in the
European Community
Dispose of this Device in Accordance
with Local Laws and Regulaons
Manufacturer (including address)
BF Type Applied Part
Aenon: Refer to User Manual
Symbol Descripon
%SpO2
BPM
/
SN