Rossmax SB200 User manual

SB200 Fingertip Pulse Oximeter
Instruction for Use
1. Safety information
WARNING: The SpO
2
device is to be operated by
trained personnel only.
WARNING: Do not use the SpO
2
device in the presence
o lammable anesthetics or gas to prevent explosion hazard.
WARNING: Do not use the SpO
2
device in the
Magnetic Resonance Imaging (MRI) ambience.
WARNING: The SpO
2
readings and pulse signals can be
a ected by the conditions o ambience and patient.
WARNING: Do not open up the SpO
2
device except or
the battery cover. The SpO
2
device is without any
user-serviceable part inside and only quali ied service
personnel can per orm maintenance service.
WARNING: Do not expose the SpO
2
device to
extreme moisture (such as rain) to ensure accurate
per ormance and device sa ety.
WARNING: I the accuracy o measurement by
the SpO
2
device is uncertain, check the patient’s vital
signs by alternate means.
Warning: This device is intended only as an
adjunct in patient assessment. It must be used in
conjunction with clinical signs and symptoms.
WARNING: Reposition the device at least once
every 4 hours to allow the patient’s skin to breath and
to check patient’s condition regularly.
WARNING: The SpO
2
device is not intended or
the use o neonatal.
WARNING: Do not use the SpO
2
device with
other devices (such as, the cu o blood pressure
monitor) that may inter ere with blood low and cause
inaccurate measurement.
Warning: The SpO
2
device will be a ected by
electromagnetic inter erence or strong ambient light
source during operation.
WARNING: User should stay calm and position inger
stably. The accuracy o measurement taken right a ter exercise
or during hand shaking could be compromised.
WARNING: SpO2 should not be applied to a body part
other than the inger or to a wounded body part.
Warning: Please remove the batteries rom the
battery compartment i the device will not be used or
a long period o time.
1. Introduction
The Fingertip pulse oximeter is to spot-check oxygen
saturation in blood (SpO
2
) and pulse rate. The pulse
oximeter is used on adults and pediatric at hospital,
clinics, and/or home.
The device contains a dual light source (Red LED and
In rared red LED) and a photodetector. Bone, tissue,
pigmentation, and venous vessels normally absorb a
constant amount o light over time. The arteriolar bed
normally pulsates and absorbs variable amounts o
light during the pulsations o blood low. The ratio o
light absorbed is translated in an oxygen saturation
measurement (SpO
2
). Because a measurement o SpO
2
is dependent on light rom the device, excessive
ambient light can inter ere with this measurement.
The wavelength o red LED is 660nm and In rared
LED is 905/880nm with maximum optical output
power o 4mW.
2. Features
 Measure and display reliable SpO
2
value and heart
rate and vascular age analysis.
 Single turn-on key or easy operation.
 Bright Organic LED display.
 Light, compact, and portable.
 Battery power is or a continuing use o 16 hours.
 Two “AAA” Alkaline batteries or power supply.
 Device will be o automatically a ter 8 seconds in
idling.
 Visual alarm and audio alarm.
3. Product introduction
Top View Bottom View
1
OLED display 6
Power On/O Button
2
Pulse strength 7
Battery compartment
3
Pulse search icon 8
Pulse rate icon
4
Alarm icon or
vascular age
9
SpO
2
icon
5
Battery indicator
. Operation
Open up battery compartment cover care ully and then
install two “AAA” Alkaline batteries according to the
(+/-) polarity.
Press the “power switch” key or 1 second to activate
the device. In ormation o version appears on the
screen. The device is then in the “sel -test” mode with
the so tware version shown. The measurement starts at
the completion o the “sel -test.”
Insert your inger into the device. For best results use
the middle inger on your le t hand.
The pulse bar with “-“icon on the screen up and down
means the measurement result will be ready soon.
The readings o oxygen saturation, pulse rate, and
pulse strength will appear on screen in 8 seconds
average. The readings and icon o vascular age will
appear on the screen in 30 seconds or maximum 2
minutes. Pressing “power switch” is to change the
viewing direction. While SpO
2
exceeds the Min.
threshold (90); the device will sound the alarm with
two beeps and alarm icon lickering. I the
measurement ails, the icon “- -“will appear on screen.
Reading lashing while SpO
2
is low. While LED or
sensor is mal unctioning, displaying “Er” signal.
Vascular age is classi ied into 6 levels as ollows:
Level 1: Artery and blood circulation in excellent condition
Level 2: Artery and blood circulation in good condition
Level 3: Artery and blood circulation in above average
Condition
Level 4: Artery and blood circulation in average condition
Level 5: Artery and blood circulation in below average
condition
Level 6: Artery and blood circulation in poor condition
Warnings: The classi ication o artery and blood
circulation condition is or re erence only. Please consult your
physician or urther advice.
When the vessel elasticity cannot be measured, it will
show
The device will turn itsel o automatically a ter
8-second idling. While the battery power is low, the
battery indicator icon will lash twice per second.
Please replace the batteries as soon as possible or the
device will be o automatically in 30 seconds.
5. Specifications
6.1 Performance
Scope o measurement: SpO
2
: 35% - 99%
Pulse rate: 30-250 bpm (beats per minute)
Accuracy: SpO
2
:70%-99%:±2%,35%-69%: unspeci ied
Pulse rate: 30-250 ± 3 bpm
6.2 Electrical specifications
Battery (2 “AAA” Alkaline batteries)
Battery capability: Can be used or 16 hours
continuously depending on the type o battery used
.
6.3 Environmental conditions
Operating temperature 5℃ - 40℃ (41℉ – 104℉)
Storage temperature: -20℃ - 70℃ (-4℉ – 158℉)
Relative humidity: 15% -95% (no condensing)
6. Physical characteristics
Weight: 37g (excluding battery) Size: 63.5 x 34 x 35 mm
6.5 Standards
IEC60601-1-2, Class B, IEC60601-1, Type BF,
ISO 80601-2-61
6.6
Markings
Type BF (Body Floating)
Drip proo
ATTENTION
Read instructions or use be ore use.
Date o manu acture
Used batteries should not be disposed o
in the household rubbish. Batteries
should be deposited at a collection point
or used batteries. At the end o its li e,
the appliance should not be disposed o
in household rubbish. Enquire about the
options or environment- riendly and
appropriate disposal. Take into account
local regulations.
Complies with the European Medical
Device Directive 93/42/EEC as amended
by 2007/47/EC
7. Problem shooting and maintenance
7.1 Dysfunction and resolution
Low battery-Please replace the battery
Switch On ailure-
 Check the power o battery
 Check the placement o battery
 Return to manu acturer or calibration
7.2 Cleaning
Sur ace cleanings is by using a so t cloth dampened
with either a commercial, non-abrasive cleaner or a
solution o 70% isopropyl alcohol in water, and lightly
wiping the sur aces o the oximeter.
Please switch o pulse oximeter be ore cleaning.
Clean the LED and photo-sensor with moist cloth or
cotton ball and alcohol gently.
The a orementioned general cleaning process is not
or in ection prevention. Please contact the specialist
or the process o contagious in ection.
7.3 Disposal
Used batteries should not be disposed o in the
household rubbish. Batteries should be deposited at a
collection point or used batteries.
At the end o its li e, the appliance should not be
disposed o in household rubbish. Enquire about the
options or environment- riendly and appropriate
disposal. Take into account local regulations.
7. Electromagnetic interference
Caution: This device has been tested and ound to
comply with the limits or medical devices to the IEC
60601-1-2 and MDD 93/42/EEC as amended by
2007/47/EC. These limits are designed to provide
reasonable protection against harm ul inter erence in a
typical medical installation. However, because o the
proli eration o radio- requency transmitting
equipment and other sources o electrical noise in
healthcare environments ( or example, electrosurgical
units, cellular phones, mobile two-way radios,
electrical appliances, and high-de inition television), it
is possible that high levels o such inter erence due to
close proximity or strength o a source may result in
disruption o per ormance o this device.
This Fingertip pulse oximeter is not designed or use
in environments in which the pulse can be obscured by
electromagnetic inter erence. During such
inter erence, measurements may seem inappropriate or
the monitor may not seem to operate correctly.
6. Warranty
The company warrants pulse oximeter at the time o
its original purchase and or the subsequence time
period o one year.
The warranty does not cover the ollowings:
 The device series number label is torn o or
cannot be recognized.
 Damage to the device resulting rom
misconnection with other devices.
 Damage to the device resulting rom accidents.
 Changes per ormed by users without the prior
written authorization o the company.
Rossmax InnoTek Corp.
12F, No. 189, Kang Chien Rd., Taipei 11494, Taiwan
Tel: [phone] Fax: [phone]
www.rossmax.com
The text is subject to change without
urther notice.
Version 11; Jan. 20, 2016
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Declaration of Conformity for EN 60601-1-2
Recommended separation distances between
portable and mobile RF communications equipment and the ME equipment
The
Finger
-
tip pulse oximeter
is intended
for use in an electromagnetic environment in which radiated RF disturbances
are controlled. The customer or the user of the Finger-tip pulse oximeter
can help prevent electromagnetic interference
by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the
Finger-
tip pulse oximeter as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequ
ency of transmitter
m
150 kHz to 80 MHz
d=








1
5,3
V
P
80 MHz to 800 MHz
d=








1
5,3
E
P
800 MHz to 2.5 GHz
d=








1
7
E
P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.7
1
1.17
1.17
2.33
10
3.7
3.7
7.37
100
11.67
11.67
23.33
Declaration – electromagnetic emissions and immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING and
are specified for use only in a shielded location
The Finger
-
tip pulse oximete
r declaration
–
electromagnetic immunity
The
Finger
-
tip pulse oximeter
system is intended for use in the electromagnetic environment specified below.
The customer or the user of the
Finger
-
tip pulse oximeter
system should assure that it is used in such a
n environment.
Immunity test IEC 60601 test level
Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000- -6
3 Vrms
150 kHz to 80 MHz
3V
Portable and mobile RF communications equipment should be
used no closer to any part of the E
QUIPMENT or SYSTEM
including cables, than the recommended separation distance
calculated from the equation applicable to the frequency of the
transmitter.
Interference may occur in the vicinity of equipment marked
with the following symbol.
Radiated RF
IEC 61000- -3
3 V/m
80 MHz to 2.5 GHz
3V/m
Declaration – electromagnetic immunity
The Finger
-
tip pulse oximeter system is intended for use in the electromagnetic environment specified below.
The customer or the user of the Finger-tip pulse oximeter system should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000- -2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should
be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000
-
-
±2 kV for power supply lines
±1 kV for input/output lines
±2 kV for power supply lines
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000
-
-
5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality should be that of a
typical commercial o
r hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000- -11
＜
＜＜
＜
5 % UT
(＞
＞＞
＞95 % dip in UT) for 0.5 cycle
0 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
＜
＜＜
＜5 % UT
(＞
＞＞
＞95 % dip in UT) for 5 sec
＜
＜＜
＜
5 % UT
(＞
＞＞
＞95 % dip in UT) for 0.5 cycle
0 % UT
(60 % dip in UT) for 5 cycles
70 % UT
(30 % dip in UT) for 25 cycles
＜
＜＜
＜5 % UT
(＞
＞＞
＞95 % dip in UT) for 5 sec
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the EQUIPMENT or SYSTEM
requires continued operation during power
mains interruptions, it is recommended th
at
the EQUIPMENT or SYSTEM be powered
from an uninterruptible power supply or a
battery.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000
-
-
8
3 A/m 3 A/m
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typi
cal commercial or hospital environment.
Declaration – electromagnetic emissions
The
Finger
-
tip pulse oximeter
is intended for use in the electromagnetic environment specified below. The customer or the user of
the Finger-tip pulse oximeter should assure that it is used in such an environment.
Emissions test Compliance
Electromagnetic environment - guidance
CE emissions
CISPR11 Group 1
The
Finger
-
tip 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.
RE emissions
CISPR11
Class B
The
Finger
-
tip 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.
Harmonic emissions
IEC 61000
-
3
-
2
Class A
Voltage fluctuations/
Flicker emissions
IEC 61000
-
3
-
3
Complies