SB220 - Heart rate monitor Rossmax - Free user manual and instructions

USER MANUAL SB220 Rossmax

The oximeter is calibrated in the factory before sale. There is no need to calibrate during its life cycle.

Cleaning

1. Please clean the surface of the device before using. Wipe the device with medical alcohol (70% isopropyl alcohol) first, and then let it dry in air or clean it by dry clean fabric. When cleaning the device with water, the water temperature should be lower than 60°C
2. Using the medical alcohol to disinfect the product after use, prevent from cross infection for next time use.

3. The best storage environment of the device is - 25°C to 70°C ambient temperature and not higher than 90% relative humidity.
   Note:

4. Do not sterilize, autoclave or immerse this device in liquid. Do not pour or spray any liquids onto the device.

5. Do not use caustic or abrasive cleaning agents, or any cleaning agent containing ammonium chloride or isopropyl alcohol.

Maintenance

Recommends user to return this device to the manufacturer perform the following checks every 24 months.

• Inspect the equipment for mechanical and functional damage or deterioration.
• Ensure all user interface keys and accessories function normally.
  Note: Manufacturer use Index2 SpO2 simulator to verify operation of the pulse oximeter equipment.

Troubleshooting

Symptoms Check points Corrections
SpO2 or pulse rate cannot displayed	Applied finger improperly	Place the finger properly and try again.
	SpO2 is too low to detect	Try again; go to consult with your physician if you are sure the device works well.
SpO2 or pulse rate are not displayed stably	Applied finger improperly	Place the finger properly and try again.
	Finger is shaking or body is moving.	Keep body steady
No display when button is pressed	Batteries run down	Replace with new batteries
	Batteries not inserted correctly.	Re-insert batteries
The display it appears suddenly	The device will auto power off when it gets no signal.	Normal
	Low battery	Replace with new batteries

Note: If the unit does not work, return it to your dealer. Under no circumstance should you disassemble and repair the unit by yourself.

Specification

SpO2
Measuring range	15%-99%, (the resolution is 1%)
Accuracy 70%-99%	8%-9%, (low 35-69%) unspecified
Optica Sensor The wavelength of red LED is 660 nm and Infrared LED is 905/880 nm with maximum optical output power of 4 mW/sr.
Pulse
Measuring range	20 bpm~250 bpm (the resolution is 1 bpm)
Accuracy L3 bpm
Power source AA×2 (Alkaline)
Battery life Continually for 16 hours with two 2 saline batteries
Operating Condition	Temperature: 35°C~40°C, 141°F~104°F),Relative humidity: 15-95% (non condensing),Atmospheric pressure: 700Pa ~ 1060Pa,AI/luole:-1,260 to 17,000 sec (-390m to 3.658m)
Storage / Transportation Condition	Temperature: 25°C~70°C, 13°F~158°F),Relative humidity: 15-90% (non condensing),Atmospheric pressure: 700Pa ~ 1060Pa,AI/luole:-1,260 to 17,000 sec (-390m to 3.658m)
Dimensions	63.5(1)×34(W)×350 T mm
Weight	Apop. 37g (w/thou; the batteries)
Standards	IEC0601 1-2, Class B, IEC5060 1, Type BF, ISO80601 2-61, IEC50601-1-11
	Type BT applied parts
IP Classification	P22: Projection age not harmful ingress of water and particulate marker
	Attention
SN	Serial number
	Manufacturer
	Date of manufacture
EC REP	Authorized representative in the European Community

Note

A description of the effect on displayed and transmitted SpO2 and pulse rate:
- Data averaging: 4 seconds for SpO2; 8 seconds for pulse rate.
- Data update delay: Less than 2 seconds.

Note:

1. The product is with a service life of 5 years in the course of regular use.

2. If any serious incident (e.g., death) has occurred in relation to the device should be reported to the dealer, manufacturer, and the competent authority of the Member State in which the user and/or patient is established.

3. The text is subject to change without further notice.

EMC guidance and manufacturer's declaration

Accumulated separation distances between particles and mobile Wi communication equipment and the kF equipment

The finger tip pulse steering is intended for use in an electronic environment in which modified the dislocation can be controlled. The motor or the motor of the finger tip pulse motor can be presented on a multi-axis interface by combining minimum distance between ports and modeled Wi command to an equipment transmission and the finger tip pulse center as recommended below according to the maximum outer power of the communication system.

Sided medium output, power. Intermittent, ^aN	Sedimentalance according to equcytes of trans- h^-1m
	100MHz/85MHz , d = ( 1.5MHz/J)	100MHz/80MHz , d = ( 1.5MHz/J)	100MHz/25MHz , d = ( 1.5MHz/J)
10	0.17	0.12	0.33
0.1	0.17	0.12	0.33
1	1.17	1.17	2.33
10	1.17	1.17	2.33
10	11.67	11.67	23.33

Declaration—electromagnetic emissions and immunity—in F10IPWThT and SYSTEMS that are on IFF-

SUPPORT NO. and art specnior for use in a streded location

The Finger-tip pulse parameter declaration - electromagnetic immunity

The Finger-tip pulse parameter system is intended for use in the electromagnetic environment specified below. The customer or the set of the Finger-tip pulse and power system should assume that it is used in

maturity cal.	EC-6001 cal.	Complete cal.	Hardware and operation guidance
Conducted RF-EC-6001-4-4	300 gm150 W/m 50 W/m	200 gm	Portable and mode RF communication equipment, the second or third part of the EQUITY/RATE or SYSTEM including cable, then the recommended installation. Distance calculation from the execution applies to the frequency of 10 units/minute. Maintenance may occur in the only use of equipment - method with the low-frequency unit
Related RF-EC-6001-4-3	300 gm50 W/m 2.5 W/m	200 gm

Declaration - electromagnetic immunity

The Finger-tip pulse diameter system is intended for use in the electromagnetic environment specified below. The customer or the user of the Finger-tip pulse width system should ensure that it is used in

Item type used	IC (60°C) method	Condition used	Environmental control and re-configuration
Demographic discharge (5°C, IC 6/300-4-7)	±1.8V contact ±2.0V air	±1.8V contact ±2.0V air	The use of the actual, concrete or concrete for the facilities are covered by different materials at the relative level to be at least 20 °C.
Drain-free temperature (m/s, IC 6/300-4-4)	1.3V for current air flux; 1.1V for current noise; 1.1s	±1.2V for current air flux;	The power quality shall be the above typical commercial or local environment.
Spring (5°C, IC 6/300-4-5)	±1.8V differential mode + 3V common mice	±1.8V differential mode + 3V common mice	The power quality shall be the right of a typical commercial or local environment.
Voltage dips, drain concentrations and voltage sources on power supply from inlet (5°C, IC 6/300-4-1)	<3% UI >30% dip in UI; 5% to 20% cycle; 40% UI >30% dip in UI; 1% to 20% cycles; 20% UI >30% dip in UI; 1% to 20% cycles; <3% UI >30% dip in UI; 5% to 5%	<3% UI >30% dip in UI; 5% to 20% cycle; 40% UI >30% dip in UI; 1% to 20% cycles; 20% UI >30% dip in UI; 1% to 20% cycles; <3% UI >30% dip in UI; 5% to 5%	The power quality shall be the right of a typical commercial or local environment. The use of the EQUIPATC or SXTV may be carried out to operation during power source interplay, and it recommended that the EQUIPATC or SXTV is powered from an unimproved power supply to nearby.
Power frequency (GHz/Hz) measured (kA, IC 6/300-4-8)	5 ohm	5 ohm	Power requiring more power than the required electrical characteristics of a small circuit with a typical commercial or local environment.

Description:electromagnetic contacts.
The finger tip probe commands, most or less in the electron-g损坏 environment specifies below, the contactor to the user of the Figure-10 for the microwave conditions that is used as an antenna.
Features and Complices	Features and components to provide
OF systems (CPB1)	Group 1
OF systems (CPB2)	Group 2
Formal scanning device (FC1002-5-1)	Group 3
Digital scanning device (FC1002-5-2)	Group 4
Complex system (FC1002-5-3)	Group 5

rossmax
Model: SB220

EN Fingertip Pulse Oximeter
www.rossmax.com

Warranty Card

This instrument is covered by a 2-year guarantee from the date of purchase, batteries and accessories are not induced. The guarantee is valid only on presentation of the guarantee card completed by the dealer confirming date of purchase or the receipt. Opening or altering the instrument invalidates the guarantee. The guarantee does not reset damage, accidents or non-compliance with the Instruction manual. Please contact your local seller/dealer or www.rassima.com

Customer Name:

Address:

Telephone:

E-mail address:

Product Information:

Date of purchase:

Store where purchased:

WARNING: The symbol on this product means that it's an electronic product and following the European directive 2012/13/E, the electronic products have to be dispuse on your local recycling centre for safe treatment.

Bosimachon Tek Corp. 3F, No. 189, Gang Chen Rd., Taike, 174, Taiwan

EC REP CVC Medical Devices & Drugs S.L. C' Haradie Large NP 18, JP 27005, Maiaya, Spain

Introduction

Rosmax Fingertip Pulse Oximeter SB220 is used to measure arterial oxygen saturation (% SpO2) of hemoglobin and pulse rate, an important indicator of your respiratory function. It is non-invasive device intended for spot-check of adult and pediatric whose age is over 3 at home, hospital and clinics.

Attention: Consult the accomp

documents. Please read this manual carefully before use. Please be sure to keep this manual.

Error code for your reference
SENSOR ERROR:

Er

Sensor cannot be detected, return the device to your local distributor or service centre.

MEASURE ERROR:

%SpO2

BPM

Signals cannot be detected, turn the device off and measure again.

Name/ Functions of each part

1. OLLD display
2. Pulse strength
3. Pulse search icon
4. Remind icon

5. Battery indicator

6. Power On/Off Button

7. Battery compartment
8. Pulse rate icon
9. SnO2 Icon

Installing Batteries

1. Use thumb to slide battery cover out.
2. Insert or replace 2 "AAA" sized batteries down with the correct electrical polarity.
   You need to replace the batteries when:
3. Low battery icon appears on display
4. The function button is pressed and nothing appears on display. Caution:

Batteries may leak or explode if used or disposed of improperly. Remove batteries if the device will be stored for long time. Do not use different types or brands of batteries at the same time. Do not mix fully charged and partially charged batteries at the same time. The device will automatically shut down in low battery.

Attaching the lanyard

1. Insert the narrow end of the
   lanyard through the holder.
2. Draw the other end of the lanyard through the loop at the narrow end and tighten.

How to use

1. Open the clip; press the Power On/Off button as ①
2. Information of software version appears. Insert one finger(left hand middle finger is recommended), nail side up, into the finger opening of the pulse oximeter as ②.

Note: If no finger insert, the device will auto shut off after 8 seconds.

1. The display shows , pulse oximeter begins its measurement.
   Note: Make sure the finger is lying flat. Do not shake and keep body steady during measurement.
2. YourSpO 2 and pulse rate values will appear on the screen after few seconds as ③.
   Note: 1. Don't remove your finger until the measurement is completed.
3. While pulse strength is low, the reading will flicker.

1. Press button shortly to reverse the display upside down.
   Note:
2. The SpO_2 sensor and photoelectric receiving tube should be arranged in a way with the subject's arteriole in a position there between.
3. Make sure the optical path is free from any optical obstacles like rubberized fabric.
4. Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared heater, direct sunlight and etc.
5. Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.
6. The device has a visual and audio signal when the measurement of SpO_2 is lower than 90% .

Cautionary Notes

• This device is to be operated by trained personnel only.
• The device has intended only for spot-checking, but not medical result evaluation.
• This device is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Factors that may degrade pulse oximeter performance or affect the accuracy of the measurement include the following:
• Do not apply the pulse oximeter on the same arm as a blood pressure cuff, arterial catheter or infusion line(s).
• Excessive light, such as sunlight or direct home lighting.
• Not steady at the site of application (e.g. trembling).
• Moisture in the device.
• Improperly applied device.
• Finger is too large or too small to fit into the device.
• Poor pulse quality.

• Venous pulsations
  • Anemia or low hemoglobin concentrations.
  • Cardiogreen and other intravascular dyes.
  • Carboxyhemoglobin.

• Methemoglobin.
  • Dysfunctional hemoglobin.
  • Artificial nails or fingemail polish.

• On fingers with anatomical changes, oedemas, scars or burns.
  Using the device for long periods may cause pain for people with circulatory disorders. Reposition the device at least once every 4 hours to allow the patient's skin to breath and to check patient's condition regularly.
  Do not use the device near flammable or explosive gas mixtures.
• Do not use the device during an MRI or CT scan, be used no closer than 30 cm (12 inches) to any part of the SpO2 device, including cables specified by the manufacturers.
  The device may not work when circulation is reduced. Warm or rub the finger, or re-position the device.
  This device is a precision electronic instrument and must be repaired by qualified technical professional's Field repair of the device is not possible. Do no attempt to open the case or repair the electronics. Opening the case may damage the device and void the warranty.
  Do not overextend the device's spring.
• A functional tester cannot be used to access the accuracy of a pulse oximeter monitor.
• Do not self-diagnose or self-medicate on the basis of the measurements without consulting your doctor. In particular, do not start taking any new medication or change the type and/or dosage of any existing medication without prior approval.
• Do not look directly inside the housing during the measurement. The red light and the invisible infra-red light in the pulse oximeter are harmful to your eyes.
• This device is not intended for use by people (including children) with restricted physical, sensory or mental skills or a lack of experience and/or a lack of knowledge, unless they are supervised by a person who has responsibility for their safety or they receive instructions from this person on how to use the device. Children should be supervised around the device to ensure they do not play with it.
• Neither of the displays for the pulse wave and pulse bar allows the strength of the pulse or circulation to be evaluated at the measurement site. Rather, they are exclusively used to display the current signal variation at the measurement site and do not enable reliable diagnostics for the pulse.
• The maximum temperature of sensors which the user will touch might reach 43°C when operating in the 40°C environment.
  The safety for user use in high temperature environment is measuring for 10 minutes, and turn it off for 20 minutes before measure again.