Sunbeam CMS50DL, 16979 - Fingertip Pulse Oximeter Manual

INTRODUCTION

READ AND SAVE THESE INSTRUCTIONS. PLEASE READ THIS INSTRUCTION MANUAL BEFORE USING THIS DEVICE. IF THE USAGE IS NOT FULLY UNDERSTOOD, PLEASE DO NOT USE THIS PULSE OXIMETER.

• Explosive hazard - DO NOT use this device in environment with inflammable gas such as anesthetic.
• DO NOT use this device during an MRI or CT scan, as the induced current may cause burns.
• DO NOT take the information displayed on this device as the sole basis for clinical diagnosis. This device is not intended as a replacement for advice from a physician or medical professional.
• This device is NOT recommended for continuous monitoring.
• DO NOT use on a fingertip that has scar tissue or or that has any other skin disorder as this may affect the measurement accuracy.
• DO NOT stare directly into the finger chamber of this device while it is turned on as the infrared light may be damaging to the eyes.
• This device contains silicone, PVC, TPU, TPE and ABS materials, whose biocompatibility has been tested in accordance with the requirements in ISO 10993-1, and it has passed the recommended biocompatibility test. Anyone with allergies to silicone, PVC, TPU, TPE or ABS should not use this device.
• DO NOT use the included lanyard if you are allergic to nylon/polyester material.
• DO NOT wrap the lanyard around the neck to avoid an accident.
• This device should be kept out of the reach of children/pets. When not in use, store this device in a dry room and protect against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the pulse oximeter.
• DO NOT throw batteries into fire.
• DO NOT discard in household trash.
• Only use recommended batteries.
• DO NOT use rechargeable batteries.
• DO NOT drop, disassemble or modify this device.
• DO NOT use this device if you think it is damaged or notice anything unusual.
• This device comprises sensitive components and must be treated with caution. Observe the cleaning, maintenance and operating conditions described in this INSTRUCTION MANUAL.
• DO NOT perform service or maintenance while this device is in use.
• DO NOT touch the battery and the person at the same time.
• DO NOT use this device if it is damaged, degraded or loosened in any way.
• Continuous use of a damaged device may cause injury, improper results, or serious danger.
• This device needs to be used and serviced in accordance with the information provided in this INSTRUCTION MANUAL.

OVERVIEW

The oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2concentration in the blood, it is an important physiological parameter for the respiratory and circulatory system. A number of diseases related to the respiratory system may cause a decrease of SpO2 in the blood.

APPLIED RANGE

This Pulse Oximeter is a non-invasive device intended for the spot-check of arterial hemoglobin (SpO2) and the pulse rate of adults in home use environments. This device is not intended for continuous monitoring. Solely for use with sporting and aviation activities. Intended to monitor heart rate during exercise.

ENVIRONMENTAL REQUIREMENTS

• Storage Environment

1. Temperature: -40°F - 140°F (-40°C - 60°C)
2. Relative humidity: ≤ 95%
3. Atmospheric pressure: 500 hPa - 1060 hPa

• Operation Environment

1. Temperature: 50°F - 104°F (10°C - 40°C)
2. Relative Humidity: ≤ 75%
3. Atmospheric pressure: 700 hPa - 1060 hPa

• Use and store this device according the ENVIRONMENTAL REQUIREMENTS section of this INSTRUCTION MANUAL.
• When the ambient temperature of the device changes too much, such as when moving from one room at a lower temperature, to another room at a higher temperature, allow the device to remain in the room for 30 minutes before using.
• DO NOT use if this device is splashed by or immersed in water.
• High temperature, high pressure, gas sterilizing or immersion disinfection for this device is not permitted. Refer to the CLEANING & DISINFECTING section of this INSTRUCTION MANUAL.
• This device may not be suitable for all users. Measurement results are for reference only. Contact your physician if you have or suspect a medical condition.
• Data averaging and signal processing have a delay in the upgrade of SpO2 data values. When the data update period is less than 30 seconds, the time for obtaining dynamic average values will increase.
• DO NOT use external coloring agents (such as nail polish, artificial nails, or colored skin care products) on the test finger as this may affect the measurement accuracy.
• Measurement accuracy may be impacted if the test finger:
  • Is too cold. Warm the test finger up before using the device.
  • Is too thin. Trying using a bigger finger such as the thumb or middle finger.
  • Has a long fingernail. Trim the fingernail or switch to a finger with a short nail.
• Refer to Figure 5 in this INSTRUCTION MANUAL for correct finger position to use this device. Improper finger position may cause inaccurate results.
• The light between the photoelectric receiving tube and the lightemitting tube of this device must pass through the subject's arteriole. Make sure the optical path is free from any optical obstacles like rubberized fabric, to avoid inaccurate results.
• Excessive ambient light may affect the measured results, such as surgical light (especially xenon light sources), bilirubin lamp, fluorescent lamp, infrared heater and direct sunlight, etc. In order to prevent interference from ambient light, make sure to place the sensor properly and cover the sensor with opaque material.
• This device should not be placed on a limb with a blood pressure cuff, arterial ductus or intraluminal tube.
• The measured value may be inaccurate during defibrillation and in a short period after defibrillation, as it does not have a defibrillation function.
• This device has been calibrated before leaving factory.
• This device is calibrated to display functional oxygen saturation.

CLINICAL RESTRICTION

1. As the measurement is taken on the basis of arteriole pulse, substantial pulsating blood flow of the user is required. For a user with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug, the SpO2 will decrease. In this case, the measurement will be more sensitive to interference.
2. The measurement will be influenced by intravascular staining agents (such as indocyanine green or methylene blue), skin pigmentation.
3. The measured value may be seemingly normal for a user who has anemia or dysfunctional hemoglobin (such as carboxyhaemoglobin (COHb), methaemoglobin (MetHb) and sulfhaemoglobin (SuHb), however the user may appear hypoxia. It is recommended to perform further assessment according the clinical situation and symptoms.
4. Pulse oxygen only has a reference meaning for anemia and toxic hypoxia, as some severe anemia patients still show better pulse oxygen measured values.
5. Contraindication: no

TECHNICAL DATA

PRINCIPLE

Fgure 1. Operating principle

Principle of this Pulse Oximeter is as follows: An experience formula of data process is established taking use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin (Hb02) in glow & near-infrared zones. Operation principle of the device is: Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning & Recording Technology, so that two beams of different wavelength of lights can be focused onto human nail tip through perspective clamp finger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on screen through treatment in electronic circuits and microprocessor.

FINGERTIP PULSE OXIMETER COMPONENTS

Fgure 2. Fingertip Pulse Oximeter

INSTALLING BATTERIES IN YOUR PULSE OXIMETER

Fgure 3. Batteries Installation

1. Slide open the back cover and install 2 AAA batteries as shown. To avoid damage, make sure the batteries align with the "+" and "–" symbols.
2. Replace the back cover.

ATTACHING THE LANYARD TO THE PULSE OXIMETER

Fgure 4. Attaching the connector loop

1. Thread the thin connector loop through the hole.
2. Insert the quick-release buckle through the loop.
3. Slide the lanyard clip into the quick-release buckle.

MEASURING PULSE RATE AND BLOOD OXYGEN LEVELS

NOTE: BEFORE YOU BEGIN, WARM THE HANDS AND FINGERS BY RUBBING THEM TOGETHER.

• Low blood perfusion can affect oximeter readings.
• 99% of reading errors are caused by cold extremities.

1. Gently squeeze to open the finger chamber.
2. Place finger fully into the chamber.
3. Press the ON button.

• Keep hand and finger still as movement may affect the reading.
• Allow at least 30 seconds for the measurement to stabilize.
• Nail polish and artificial fingernails may cause false or no results.

Figure 5. Put finger in position

READING THE RESULTS

CLEANING & DISINFECTING THE PULSE OXIMETER

1. Remove batteries before cleaning.
2. Wipe finger chamber and exterior surface with a disinfecting solution of at least 75% isopropyl alcohol.

• Do not immerse in water or liquid.
• Do not spray any liquid directly onto the device.

3. Allow to air-dry or wipe dry with a clean, soft cloth.

HIGH-PRESSURE STERILIZATION CANNOT BE USED ON THE DEVICE

MAINTAINING & STORING THE PULSE OXIMETER

1. Inspect this device regularly. Discontinue use if you notice visible damage.
2. Replace the batteries when low-battery indicator appears or device does not turn on.
3. Remove the batteries before storage or when not in use for an extended timeframe.
4. Make sure the device is clean and dry before storage.
5. Store this device in a dry, well-ventilated location away from extreme temperatures.

DISPOSAL OF DEVICE & BATTERIES

At the end of its useful product life, dispose of/recycle this device and used batteries following local regulations to avoid environmental pollution.

• DO NOT discard in household trash.
• NEVER dispose of batteries in fire.
• Dispose of/recycle used batteries following local regulations to avoid environmental pollution.

LIMITED 2-YEAR WARRANTY

This product* has a limited warranty of 2 years from the original date of purchase against workmanship and defects in material. If under normal use, your product fails to operate, please contact our customer service department at info@stareliteinc.com. A refund or replacement will be provided to you with proof of purchase. Star Elite Inc. may deny claims of damage caused by misuse or modifications of this product.
*Excluding accessories (Batteries, Lanyard & Carrying case)

FAQS / TROUBLESHOOTING

Q: The pulse oximeter does not turn on.

A: Check the batteries for correct installation. Replace both AAA batteries when the battery indicator is low.

Q: The display screen turns off suddenly.

A: The device enters energy-mode when not in use for several seconds. Press ON button. The batteries are low. Install 2 new AAA batteries.

Q: The display is not showing SP02 and Pulse Rate.

A:Make sure the finger is fully inserted into the finger chamber. Remain still while measuring. Nail polish or artificial nails may interfere with an accurate reading.

KEY OF SYMBOLS

Note: This device and INSTRUCTION MANUAL may not contain all the following symbols.

Symbol	Description
	Refer to instruction manual/booklet
%SpO 2	Pulse oxygen saturation (%)
PRbpm	Pulse rate (beats/minute)
	The battery voltage is deficient (change the battery to avoid inaccurate measurements)
	No finger inserted Inadequate signal
	Battery positive electrode
	Battery cathode
	Exit standby mode
	Adjust screen brightness
SN	Serial number
	Alarm inhibit
	WEEE (2002/96/EC)
IP22	Ingress of liquids rank
	Storage and Transport Temperature limitation
	Storage and Transport Humidity limitation
	Storage and Transport Atmospheric pressure limitation
	This side up
	Fragile, handle with care
	Keep dry
	Recyclable

EMC DECLARATION

• The device is subject to special EMC precautions and it must be installed and used in accordance with these guidelines.
• The electromagnetic field can affect the device performance, so other equipment used near the device must meet the corresponding EMC requirements. Mobile phones, X-rays or MRI devices are possible interference source, as they can emit high-intensity electromagnetic radiation.
• Refer to above chapters for the minimum value of user's physiological signal. Inaccurate result will appear when the device operates with the values lower than the descriptions in above chapter.
• The use of ACCESSORIES, transducers and cables other than those specified, with the exception of transducers and cables sold by the MANUFACTURER of the ME EQUIPMENT or ME SYSTEM as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
• This device should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, it should be observed to verify normal operation in the configuration in which it will be used.
• Devices or systems may still be interfered by other equipment, even if other equipment meets the requirements of the corresponding national standard.
• Basic performance: SpO2measured range: 70% - 100%, absolute error: ±2%; Pulse Rate measured range: 30 - 250 beats/minute, accuracy: ±2 beats/minute or ±2%, whichever is greater.

GUIDANCE AND MANUFACTURER'S DECLARATION - ELECTROMAGNETIC EMISSIONS

FOR ALL EQUIPMENT AND SYSTEMS

GUIDANCE AND MANUFACTURER'S DECLARATION –
ELECTROMAGNETIC IMMUNITY

FOR ALL EQUIPMENT AND SYSTEMS

• At 80 MHz and 800 MHz, the higher frequency range applies.
• These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

^a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which this Pulse Oximeter is used exceeds the applicable RF compliance level above, this Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating this Pulse Oximeter.
^b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/M.

RECOMMENDED SEPARATION DISTANCES

BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE EQUIPMENT OR SYSTEM –
FOR EQUIPMENT OR SYSTEM THAT ARE NOT LIFE-SUPPORTING

If you have any problems, please do not contact the store.
Contact our customer service at 1-877-383-6399
(8:30 am - 5:00 pm EST) Monday - Friday
or contact us at
info@stareliteinc.com
Our customer service will be happy to assist you.

Documents / Resources

Download manual

Here you can download full pdf version of manual, it may contain additional safety instructions, warranty information, FCC rules, etc.

Download Sunbeam CMS50DL, 16979 - Fingertip Pulse Oximeter Manual