Rossmax SD100 - Fingertip Pulse Oximeter Manual

Introduction

Rossmax Fingertip Pulse Oximeter SD100 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.

Attention: Consult the accompanying documents. Please read this manual carefully before use. Please be sure to keep this manual.

Name/ Functions of each part

1. SpO2 icon
2. Pulse strength indication
3. Beats per minute
4. Pulse rate icon

5. Power On Button
6. Battery icon
7. SpO2 value
8. Battery compartment

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

1. Battery icon is blinking on display.
2. The function button is pressed and nothing appears on display.

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.

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 button as Œ.
2. Information of software version appears; insert one finger, nail side up, into the finger opening of the pulse oximeter.
   Note: if no finger insert, the device will auto shut off after 8 seconds.
3. The pulse strength indication shows "", pulse oximeter begins its measurement as .
   
   Note: make sure the finger is lying flat, Do not shake and keep body steady during measurement as Ž.
   
4. Your SpO2 and pulse rate values will appear on the screen after few seconds as .
   

Note:

1. Don't remove your finger until the measurement is completed.
2. If SpO2 and pulse rate cannot be detected, " " will appear on the screen as .
   
3. While pulse strength is low, the reading will flicker.

Note:

1. The SpO2 sensor and photoelectric receiving tube should be arranged in a way with the subject's arteriole in a position there between.
2. Make sure the optical path is free from any optical obstacles like rubberized fabric.
3. Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared heater, direct sunlight and etc.
4. Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.

Error code for your reference

SENSOR ERROR:	Sensor cannot be detected, return the device to your local distributor or service centre.
MEASURE ERROR:	Signals cannot be detected, turn the device off and measure again.

Cautionary Notes

• This device is to be operated by trained personnel only.
• This device has no audible and it 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 fingernail 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 SD100, including cables specified by the manufacturer
• 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 professionals. 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 infrared 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.
• A warning that other cables and accessories may negatively affect EMC performance.
• A warning regarding stacking and location close to other equipment.
• A warning that use of other accessories results in non-compliance.
• The safety way in high-temperature environment for all people use is measuring for 10 minutes, and turn it off for 20 minutes before measure again.
• The oximeter is calibrated in the factory before sale, there is no need to calibrate it during its life cycle.

Cleaning

1. Please clean the surface of the device before using. Wipe the device with medical alcohol (70% (w/w) Ethanol) 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:

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

Troubleshooting

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	35%~99%, (the resolution is 1%).
Accuracy	70%~99%: ±2%, Below 35~69%: unspecified.
Optical 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	30 bpm~250 bpm (the resolution is 1 bpm)
Accuracy	±3 bpm
Power source	AAA × 2 (Alkaline)
Battery life	Continually for 16 hours with two alkaline batteries
Operating Condition	Temperature: 5°C~35°C (41°F ~ 95°F), Relative Humidity: 15-95% (non condensing), Atmospheric pressure: 700hPa ~ 1060hPa, Attitude: -1,280 to 12,000 feet (-390m to 3,658m)
Storage / Transportation Condition	Temperature: -25°C~+70°C(-13°F ~ 158°F), Relative humidity: 15-90%(non condensing), Atmospheric pressure: 700hPa ~ 1060hPa, Attitude: -1,280 to 12,000 feet (-390m to 3,658m), The time from 70°C or -25°C back to use: 3 hours
Dimensions	61.3(L) × 31W) × 36.7(H) mm
Weight	About 33g (without the batteries)
Standards	IEC60601-1-2, Class B, IEC60601-1, Type BF, ISO80601-2-61, IEC/EN60601-1-11
	Type BF applied parts
IP Classification	IP22: Protection against harmful ingress of water and particulate matter