John Bunn DigiOx Operation Manual

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
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.
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.
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)
1 One lanyard
2 Two AAA alkaline batteries
3 One 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
Display screen Organic LED Display
Power supply Two 1.5V AAA alkaline batteries
requirement
SpO Parameter Measuring range: 0%-100%
2
Specifications
Accuracy: 70%-100%, ±3% < 70%,
no definition
Pulse Rate Measuring range: 30-235 bpm
Parameter
Accuracy: 30-99bpm, ±2 bpm; 100-
Specifications
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
16
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
OVERVIEW
Appearance
display screen battery cover
power/display
button
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
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
on, then the SpO value and pulse rate value display
2
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,
Storage: -4°F - 158°F
or even damage it)
(-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
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
17
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 (SpO ) and pulse rate in
2
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
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
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 Figure 3
battery installation
installation will prevent the
device from operating.
OPERATION INSTRUCTIONS
Notes:
Clean the test finger with isopropyl alcohol before and
after each measurement. Ensure that the finger is dry
before being inserted into the oximeter.
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
SpO and Finger Reposition finger
2
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 SpO
Remeasure; if
2
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
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.
18
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
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
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
Figure 4
(ensure that the finger is
operation
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
the values become stable, the
user can read the information
Figure 5
on the display screen.
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
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.
19
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
a. Press the Power/Display Button
once more; the screen will
rotate 180° and display as
shown in Figure 6.
Figure 6
b. Press the Power/Display
Button once more; the screen
will rotate 90° and display as
shown in Figure 7.
c. Press the Power/Display Button
Figure 7
once more; the screen will
rotate 180° and display as
shown in Figure 8.
d. Press the Power/Display Button
Figure 8
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.
Figure 9
e. Press the Power/Display Button
once more; the screen will now
show pulse as a hollow wave-
form bar graph along bottom of
screen, as shown in Figure 10.
Figure 10
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
Serial number
SN
Not for continuous monitoring
15
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