Rossmax SB100 User manual

SB100 Fingertip Pulse Oximeter
Instruction for Use
1. Safety information
WARNING: The SpO2 device is to be operated
by trained personnel only.
WARNING: Do not use the SpO2 device in the
presence o lammable anesthetics to prevent
explosion hazard.
WARNING: Do not use the SpO2 device in the
Magnetic Resonance Imaging (MRI) ambience.
WARNING: The SpO2 readings and pulse
signals can be a ected by the conditions o ambience
and patient.
WARNING: Do not open up the SpO2 device
except or the battery cover. The SpO2 device is
without any user-serviceable part inside and only
quali ied service personnel can per orm maintenance
service.
WARNING: Do not expose the SpO2 device to
extreme moisture (such as rain) to ensure accurate
per ormance and device sa ety.
WARNING: I the accuracy o measurement by
the SpO2 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.
WARNING: The SpO2 device is not intended or
the use o neonatal.
WARNING: Do not use the SpO2 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 SpO2 device will be a ected by
electromagnetic inter erence during operation.
Warning: Please remove the batteries rom the
battery compartment i the device will not be used or
a long period o time.
2. Introduction
The Fingertip pulse oximeter is to spot-check oxygen
saturation in blood (SpO2) and pulse rate. The pulse
oximeter is used on adults and pediatric whose age is
over 3 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. The ratio o light absorbed
is translated in an oxygen saturation measurement
(SpO2). Because a measurement o SpO2 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.
There is no visual or audio alarm.
3. Features
 Measure and display reliable SpO2 value and heart
rate.
 Single turn-on key or easy operation.
 Bright 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.
. Product introduction
Top View Bottom View
1 % SpO2 signal 5 Power On/O Button
2 Pulse strength 6 Battery compartment
3 Pulse rate 7 SpO2 icon
4 Beats per minute 8 Battery indicator
5. 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. All icons appear on the LED 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.”
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 LED screen in 8 seconds
average. I the measurement ails, the icon “- -“ will
appear on LED screen. Reading lashing while SpO2
is low. D isplay “Er” signal while LED or sensor is
mal unctioning.
The device will turn itsel o automatically a ter
8-second idling.
While the battery power is low, the LED icon will
appear. Please replace the batteries as soon as possible
or the device will be o automatically in 30 seconds.
6. Specifications
6.1 Performance
Scope o measurement: SpO2: 35% - 99%
Pulse rate: 30-250 bpm (beats per minute)
Precision: SpO2: 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)
Attitude: -1,280 to 12,000 eet(-390m to 3,658m)
Atmospheric Pressure: 700 hPa to 1060 hPa (hPa)
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,ISO9919
6.6 Markings
Type BF (Body Floating)
Drip proo
Date o manu acture
CONSULT INSTRUCTIONS FOR USE
ATTENTION
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.
Alarm unction is o
Complies with the European Medical
Device Directive 93/42/EEC
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. 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.
8. 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 114, Taiwan
Tel: + 886-2-2659-7888
Fax: + 886-2-2659-7666
www.rossmax.com
The text is subject to change without urther notice.
Version 20 , September 21, 2015
IBP innovative business promotion GmbH
Botzstrasse 6, D-07743 Jena, Germany
1 8
7
6
2
3
4
5

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 communication
s
equipment.
Rated maximum output
power of transmitter
W
Separation distance according to frequency 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 oximeter
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
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 EQUIPMENT 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 co
mmon mode
±
1 kV
differential
mode
±
2 kV common mode
Mains power quality should be that of a
typical commercial or 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 that 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
typical 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