8. Product Accessories
1 One hang lace
2 Two AAA batteries
3 One Instruction manual
9. Battery Installation
Remove batter cover. Install two (2) AAA batteries
into the battery cassette with the proper polarity
alignment.
Replace cover horizontally along the arrow shown
as below:
Notes:
Battery polarities must be correctly
installed.
Otherwise, damage to the device may occur.
Install or remove batteries with care, and in the
right position, so as to not damage the device.
Batteries should be removed from the Oximeter
if the unit will not be used for an extended period
of time (battery corrosion may occur).
10. Hang Lace Installations
1. Thread thinner end of the hang lace
through the eyelet on end of the unit.
2. Thread thicker end of the lace through the
loop of the thread that was just inserted in eyelet.
Pull thicker thread firm. Do not over tighten.
11. Maintenance and Storage
12. Calibrating the pulse oximeter
14. Detailed descriptions of product functions
13. Declaration
15. Possible Problems and Resolutions
Problems
Possible
reason
Solution
The Oximeter
can not be
powered on
Display screen
is suddenly off
1. The product
is automatically
powered off
when no signal
is detected
longer than 8
seconds
2. Power level
of batteries is
inadequate.
1. Normal
2. Replace the
batteries
“Error3” or
“Error4”
displayed on
screen
1 .Low power
2. Receiving
tube being
shielded or
damaged
together with
broken
connector.
3. Mechanical
misplace for
receive-emissi
on tube
4. Amp circuit
malfunction.
1. Change
battery
2. Contact your
local service
center
3. Contact your
local service
center
4. Contact your
local service
center
17. Symbol Definitions
16. Guidance and manufacture’s declaration
- electronmagnetic emissions -
for all Equipmnet and Systems
1. The functional tester cannot be used to
assess the accuracy of the oximeter.
2. Index 2 that is made by Bioteck company is a
function tester. Set Tech to 1. R curve to 2, then
user can use this particular calibration curve to
measure the oximeter.
3. The test methods used to establish the SpO2
accracy is clinical testing. The oximeter used to
measure the arterial hemoglobin oxygen
saturatin levels and these levels are to be
compared to the levels determined from arterial
blood sampling with a CO-oximeter.
EMC of this product comply with IEC60601-1-1-2
standards.
The materials which the user comes in contact with
are not toxic and no adverse effects on tissues. The
unit complies with ISO10993-1 -5, -10.
1. Display Type: OLED display
2. SPO2 :
Measurement range: 0-100%
Accuracy: ±2 on the range of 70% - 100%
< 70% no definition
3. Pulse Rate:
Measure range: 30 to 235 BPM (Beats Per
Minute)
Accuracy: ±2 BPM
4. Power Requirements: Two AAA 1.5V Alkaline
Batteries
Power consumption: less than 40mA
Low power indication:
Battery Life: Two AAA 1.5V, 600mAh alkaline
batteries can be continuously operated for
approximately 30 hours.
5. Dimension:
Length: 58mm (2.28 inches)
Width: 32mm (1.25 inches)
Height: 34mm (1.33 inches)
Weight: 50g / 1.7 oz. (including two AAA batteries)
6. Environment Requirements:
Operation Temperature: 5 to 40°C (41 to 104° F)
Storage Temperature: -10 to 40°C (14 to 104° F)
Ambient Humidity: 15% to 80% in operation
10% to 80% in storage
7. Declaration: EMC of this product complies with
IEC60601-1-1-2 standard.
8. Measurement Performance in Weak
Filling Condition: required the test equipment
(BIO-TEK INDEX Pulse Oximeter tester) the
pulse wave is available without failure when
the simulation pulse wave amplitude is at 6%.
9. Interference Resistance Capacity aginst
Ambient Light: Device work normally when mixed
noise produced by BIO-TEK INDEX Pulse
Oximeter tester.
SpO2 or PR
can not be
displayed
normally
SpO2 or PR is
showed
unstably
“Error7”
displayed on
screen
Guidance and manufacture’s declaration -
electromagnetic emission
The Pulse Oximeter is intended for use in the
electromagnetic environment specified below. The
customer of the user of the Pulse Oximeter should
assure that it is used in such an environment.
Emission test Compliance
Electromagnetic
environment-guldance
RF emissions
CISPR 11
Group 1
The Pulse Oximeter
uses RF energy only
for its internal function.
Therefore, it’s 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 use
for domestic purposes.
Mfg. For
：
Spiracle Technology
16520 Harbor Blvd. #D
Fountain Valley, CA 92708 U.S.A.
Ph
：
(714) 418-1091
Fax
：
(714) 418-1095
www.spiracle.com
email
：
EUROPEAN CONTACT:
Ferno Washington Italia s.r.l.
via Benedetto Zallone n.26
40066, Pieve di Cento (Bo) - Italy
P +39 051 6860028 / F +39 051 6861508
Revision: July 2013
Symbol Definition
The equipment type
is BF
Refer to user manual
before application
Hemoglobin saturation
Heart rate (BPM)
Low power indication
SN
Serial No. (Attached
inside of the unit )
Notes:
Please remove the battery when product
will not be in used for period of time.
No SpO
2
alarm
SpO
2
%
PR
bpm
1. Replace the batteries when the low voltage lamp
is displayed on the screen.
2. Clean surface of the finger type Oximeter before it
is used in diagnosis for patients.
3. Remove the batteries inside the battery cassette
if the Oximeter will not be operated for an
extended period of time.
4. It is best to store the product in a place where
ambient temperatures are –10 to 40°C (14 to
104°F) and humidity is 10% to 80%.
5. It is recommended that the product be kept in a
dry environment for storage. A wet and excessive
humid environment might affect the units
performance, damage the product or effect its
useful life.
6. Please follow the local laws and protocols for
proper disposable of used batteries.
1.Retry by
inserting the
finger until fully
engaged
2. Repeat test
method. If
problem
continues, follow
local protocols for
patient
assessment
and treatment.
1. Finger is not
plugged in
correctly
2. Patient’s
Oxyhemoglobin
value is too
low to be
measured
1. Finger might
not be plugged
deep enough
2. Finger is
trembling or
patient’s body
is in movement
status
1.Retry by
inserting the
finger until fully
engaged
2. Try not to
move
1. Change
batteries
2. Contact your
local service
center
3 Contact your
local service
center
1. Low power
2. Emission
tube damaged.
3. Current
control circuit
malfunction.
NOTIFIED BODY: DET NORSKE VERITAS 0434
1. Replace
Batteries.
2. Remove and
reinstall the
batteries
3. Contact your
local service
center
1. Low or dead
batteries.
2. Batteries
might be
installed
incorrectly
3. The Oximeter
might be
damaged