John Bunn DigiO2 User manual

Operation Manual
Important: Do not operate the John Bunn DigiO
2
Finger
Pulse Oximeter without rst reading and understanding
this manual! Save this manual for future use.
JB02007-INS-LAB-RevC16

JB02007-INS-LAB-RevC16 2
CONTENTS
INTRODUCTION............................................................................................................................................3
IMPORTANT SAFETY GUIDELINES - PLEASE READ BEFORE USE...............................................3
INTENDED USE.....................................................................................................................................6
CONTRAINDICATIONS.........................................................................................................................6
DECLARATION OF CONFORMITY: .....................................................................................................6
OVERVIEW ....................................................................................................................................................7
APPEARANCE ......................................................................................................................................7
FEATURES ............................................................................................................................................8
NAME AND MODEL ..............................................................................................................................8
BATTERY INSTALLATION ............................................................................................................................8
OPERATION INSTRUCTIONS ......................................................................................................................9
ACCESSORIES (INCLUDED) .....................................................................................................................12
REPAIR AND MAINTENANCE....................................................................................................................12
MAINTENANCE...................................................................................................................................12
CLEANING AND DISINFECTION........................................................................................................13
TROUBLESHOOTING.................................................................................................................................14
SYMBOL KEY..............................................................................................................................................15
TECHNICAL SPECIFICATIONS..................................................................................................................15
LIMITED WARRANTY .................................................................................................................................17

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INTRODUCTION
Dear User: Please read and understand all instructions before using the John Bunn
DigiO2Finger Pulse Oximeter, JB02007.
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 DigiO2Finger 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 specic 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 or moderate personal injury.
sNOTICE: Indicates a potential hazard or unsafe practice that, if not avoided, could
result in minor personal injury or product/property damage.
Info: Provides application recommendations or other useful information to ensure that you
get the most from your product.
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.

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WARNING: If components are damaged or missing, contact your dealer immediately.
DO NOT use substitute parts.
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. Thereafter,
inspect the device at least once a week.
WARNING: GF Health Products, Inc. assumes no responsibility for any damage or
injury caused by improper installation or use of this product.
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: EXPLOSION HAZARD: Do not use the oximeter in the presence of
ammable anesthetics, explosive substances, vapors or liquids.
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 nger for more than two hours. If any readings are found to be abnormal,
please change the position of the sensor.
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.

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WARNING: Magnetic and electrical elds 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.
WARNING: DO NOT clip this device on edema or tender tissue.
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: 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.
WARNING: To ensure patient safety, use only parts and accessories specied in this
manual.
WARNING: Keep the oximeter away from dust, vibration, corrosive substances,
explosive materials, high temperature and moisture.
WARNING: If the oximeter gets wet, stop operation immediately 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.
sNOTICE: DO NOT use sharp objects to press the front panel button.
s NOTICE: DO NOT immerse the oximeter in liquid.

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sNOTICE: DO NOT subject the oximeter to high temperature or high pressure steam
disinfection. Refer to the REPAIR AND MAINTENANCE/Cleaning and Disinfection
section of this manual for instructions for cleaning and disinfection.
Intended use
The John Bunn DigiO2Finger Pulse Oximeter, which combines a sensor and monitor
into one device, is used to measure pulse oxygen saturation (SpO2 ) value, pulse rate
value, and blood perfusion index (PI) or pulse strength in home or clinical settings.
It is designed for adult and pediatric patients, and ts ngers of thickness .39" - .87"
(10mm - 22mm).
Contraindications
WARNING: DO NOT use the oximeter while the patient is undergoing MRI or CT
scanning.
Declaration of Conformity:
This device complies with the
following standards: IEC 60601-1
ISO 9919
ISO 21647
and follows the provisions of the council directive MDD93/42/EEC

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OVERVIEW
Appearance
display
key
nameplate
battery
cover
lanyard
hole
display
screen
rubber
cushion
Figure 1
front view
Figure 2
rear view

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Features
The John Bunn DigiO2Finger 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 pulse
oxygen saturation (SpO2 ) value, pulse rate value, and blood perfusion index (PI) or
pulse strength. When a nger is inserted into the sensor's rubber cushion, the SpO2
value and pulse rate value automatically display on the screen. The oximeter features
a bright-color LED screen with multi-directional displays that enable the user to read
results from any angle. The oximeter features both audible and visible alarms and a low
voltage indicator. The oximeter powers off automatically in eight seconds when not in
use. The oximeter provides approximately 2,000 spot checks with the use of alkaline
batteries.
Name and Model
Name: John Bunn DigiO2Finger Pulse Oximeter
Model: JB02007
BATTERY INSTALLATION
1. Refer to Figure 3; insert two AAA batteries, oriented
as shown, into the battery compartment.
2. Replace the cover.
Info: Ensure the batteries are correctly installed. Incorrect
installation will prevent the device from operating. Figure 3
battery installation

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OPERATION INSTRUCTIONS
CAUTION: Do not use the sensor if it is damaged.
Info: Ensure the finger is dry before being inserted into the oximeter.
Info: Do not shake the finger; keep finger motionless during oximeter use.
Info: Avoid placing the device on a limb which is wrapped with a cuff for blood pressure
measurement or undergoing venous infusion.
Info: 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.
Info: Vigorous exercise and electrosurgical device interference may affect the measuring
accuracy.
1. Open the clip as shown in Figure 4.
2. Insert nger into the clip's rubber cushion
(ensure that the nger is correctly positioned),
and then gently clip the nger.
3. The device will power on automatically in two
seconds, and start to display the software
version number.
Figure 4
operation

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4. The screen will then display the data as
shown in Figure 5. After the waveform
and value become stable, the user can
read the information on the display
screen.
5. When the screen displays as shown
in Figure 5, press the Display Key to
change the display screen's orientation:
a. Press the Display Key once; the
display screen will rotate 180° and
display as shown in Figure 6.
b. Press the Display Key twice; the
screen will now display as shown in
Figure 7.
c. Press the Display Key three times;
the display screen will rotate 180°
and display as shown in Figure 8.
d. Press the Display Key four times;
the display screen will return to the
original screen as shown in Figure 5.
Figure 5 Figure 6
Figure 7 Figure 8

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6. Press the Display Key for approximately
two seconds; the screen will display as
shown in Figure 9. Differences between
Figure 9 and Figure 5 are as follows:
a. In Figure 5, SpO2and PR (pulse rate)
are being monitored and displayed
on the screen.
b. In Figure 9, SpO2and PI (blood
perfusion index) are being
monitored and displayed on the
screen.
7. Press the Display Key twice; the screen will now display as shown in Figure 10.
8. The Display screen as shown in Figure 9 or Figure 10 will return to the original
screen as shown in Figure 5 or Figure 6 if without operation in ten seconds.
9. Alarm Indicator: When measuring, if SpO2value and pulse rate value are outside
the preset alarm limits, the device will alarm automatically and the value which
is outside the limit will ash on the screen; press the Display Key to suspend the
alarm beep (see alarm table below).
Alarm SpO2Outside limit alarm: three beeps Preset limit: ≤90%
Pulse Rate Outside limit alarm: two beeps Preset limits: Low ≤50bpm, High ≥120bpm
Figure 9 Figure 10

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ACCESSORIES (INCLUDED)
1 One lanyard
2 Two AAA alkaline batteries
3 One pouch
4 One operation manual
5One quality certificate
REPAIR AND MAINTENANCE
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.
Maintenance
In order to ensure the oximeter's longevity and continued dependable operation,
please observe the following maintenance recommendations.
Change the batteries when the low-voltage indicator displays.
Clean the surface of the device before using: Wipe the device with 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.
Keep the device in a dry environment. Humidity may shorten the life of the device, or even damage it.

JB02007-INS-LAB-RevC16 13
Environmental requirements Operation Temperature: 41°F ~104°F (5°C ~40°C)
Relative humidity: 30%~80%
Atmospheric pressure: 10.15 psi~15.37 psi (70kPa~106kPa)
Storage Temperature: -4°F to 131°F (-20ºC to 55ºC)
Relative humidity: < 95%
Cleaning and Disinfection
1. Do not immerse the device in liquid. Clean the device only by using a surface-clean
technique: Wipe with a clean, soft cloth saturated with a solution of 75% isopropyl
alcohol.
If low-level disinfection is required, wipe with a 1:10 bleach to water solution.
2. Wipe with a clean, soft cloth saturated with clean water and air dry, or dry with a
clean, soft cloth.
s NOTICE: Do not immerse the device in liquid.
sNOTICE: Do not clean the device with abrasive cleansers.
sNOTICE: Do not sterilize the device with irradiation, steam, or ethylene oxide.
sNOTICE: Do not disinfect the device with high temperature or high pressure steam.

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TROUBLESHOOTING
Problem Possible Reason Solution
The SpO2and Pulse Rate display is
unstable 1. The finger is not correctly positioned in the device 1. Position the finger correctly and try again
2. The finger is shaking or the
patient is moving 2. Ensure that patient is able to remain immobile
The device does not turn on 1. The batteries are low 1. Replace the batteries
2. The batteries are not correctly
installed 2. Reinstall batteries
3. The device has malfunctioned 3. Contact your GF distributor
The indicator light suddenly turns
off 1. The device powers off automatically when it gets no
signal for eight seconds
1. Normal
2. The batteries are almost
drained 2. Replace the batteries

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SYMBOL KEY
Symbol Description
Type BF
WARNING: See operation manual
The pulse oxygen saturation
PI Perfusion Index or Pulse Strength
Pulse rate (beats per minute)
Low battery voltage
SN Serial number
Do not treat this device as household waste—separate collection required
TECHNICAL SPECIFICATIONS
Display mode LED Display
Power supply requirement Two 1.5V AAA alkaline batteries
Supply voltage: 2.7V~3.3V
Operating current ≤40mA

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TECHNICAL SPECIFICATIONS continued
SpO2parameter
specifications Measuring range: 35%~99%
Accuracy: ±2% during 75%~99%, ±3% during 50%~75%
Pulse rate parameter
specifications Measuring range: 25-250 bpm
Accuracy: ±2 bpm or ±2%
Pulse strength parameter
specifications: Measuring range: 0.2-20%
Accuracy: ±0.1% during 0.2%~2%, ±1% during 2%~10%, ±2% during 10%~20%
Resistance to interference of
surrounding light The difference between the value measured in the condition of indoor natural light and that of darkroom is less than ±1%
Resistance to interference of
man-made light Values of SpO2and pulse rate can be accurately measured by pulse oxygen simulator
Dimensions (L x W x H) 2.59" x 1.42" x 1.3" (66 mm x 36 mm x 33 mm)
Net weight with batteries 2 oz. (60g)
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
Electromagnetic compatibility: Group I, Class B

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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 proper 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. This limited warranty shall only apply to defects that are reported to GF’s customer service team 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 three (3) years.
The applicable warranty period shall commence from date of shipment to the original customer, 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: tips, 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
8) 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 WARRANTYAND 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.
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.
3) Claims for any short shipment must be made within three (3) days of the invoice date.

1.770.368.4700
Information contained herein is subject to change.
The most current and complete product information can be found on our website.
www.grahameld.com
© 2007, GF Health Products, Inc. All Rights Reserved.
John Bunn and Graham-Field are trademarks of GF Health Products, Inc.
GF Health Products, Inc. is an ISO 13485 Certied Company.
Manufactured for GF Health Products, Inc.
Made in China

JB02007-INS-LAB-RevC16
Manual de Operación
Importante: No debe operar el John Bunn DigiO
2
Oxímetro sin leer y entender este manual!
Guarde este manual para uso en el futuro.

JB02007-INS-LAB-RevC16 2
CONTENIDOS
INTRODUCCIÓN............................................................................................................................................3
DIRECTIVAS IMPORTANTES DE SEGURIDAD–POR FAVOR DE LEER ANTES DE USO.......................3
USO ENTENDIDO .................................................................................................................................6
CONTRAINDICACIONES......................................................................................................................6
DECLARACIÓN DE CONFORMIDAD: .................................................................................................6
GENERALIDADES ........................................................................................................................................7
APARIENCIA .........................................................................................................................................7
CARACTERÍSTICAS .............................................................................................................................8
NOMBRE Y MODELO ...........................................................................................................................8
INSTALACIÓN DE LAS BATERÍAS..............................................................................................................8
INSTRUCCIONES DE OPERACIÓN.............................................................................................................9
ACCESORIOS (INCLUIDOS) ......................................................................................................................12
REPARACIÓN Y MANTENIMIENTO...........................................................................................................12
MANTENIMIENTO ...............................................................................................................................12
LIMPIAR Y DESINFECTAR .................................................................................................................13
DETECTANDO PROBLEMAS.....................................................................................................................14
SÍMBOLOS ..................................................................................................................................................15
ESPECIFICACIONES TÉCNICAS...............................................................................................................15
GARANTÍA LIMITADA.................................................................................................................................17