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Sunbeam CMS50DL - User Manual

Sunbeam CMS50DL
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Explosive hazard - DO NOT use this device in environment with
inammable 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 ngertip 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 nger 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 re.
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 HbO
2
in the total Hb in the blood,
so-called the O
2
concentration 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 SpO
2
in the blood.
APPLIED RANGE
This Pulse Oximeter is a non-invasive device intended for the spot-check
of arterial hemoglobin (SpO
2
) 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
a) Temperature: -40°F - 140°F (-40°C - 60°C)
b) Relative humidity: 95%
c) Atmospheric pressure: 500 hPa - 1060 hPa
Operation Environment
a) Temperature: 50°F - 104°F (10°C - 40°C)
b) Relative Humidity: 75%
c) Atmospheric pressure: 700 hPa - 1060 hPa
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.
Keep hand and nger still as movement may affect the reading.
Allow at least 30 seconds for the measurement to stabilize.
Nail polish and articial ngernails may cause false or no results.
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 (Hb0
2
) 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 nger-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.
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.
Figure 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.
1. Gently squeeze to open the nger chamber.
2. Place nger fully into the chamber.
3. Press the ON button.
Fingertip Pulse Oximeter
Instruction Manual
Figure 1.
Operating principle
AAA
AAA
Figure 2. Fingertip Pulse Oximeter
AAA
AAA
AAA
AAA
Figure 5.
Put nger in position
WARNINGS
PRINCIPLE
TECHNICAL DATA
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.
ATTENTION
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
SpO
2
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, articial nails,
or colored skin care products) on the test nger as this may affect the
measurement accuracy.
Measurement accuracy may be impacted if the test nger:
-Is too cold. Warm the test nger up before using the device.
-Is too thin. Trying using a bigger nger such as the thumb or middle nger.
-Has a long ngernail. Trim the ngernail or switch to a nger with a
short nail.
Refer to Figure 5 in this INSTRUCTION MANUAL for correct nger
position to use this device. Improper nger position may cause
inaccurate results.
The light between the photoelectric receiving tube and the light-
emitting tube of this device must pass through the subjects 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,
uorescent 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 debrillation and in
a short period after debrillation, as it does not have a debrillation
function.
This device has been calibrated before leaving factory.
This device is calibrated to display functional oxygen saturation.
CLINICAL RESTRICTION
A. As the measurement is taken on the basis of arteriole pulse, substantial
pulsating blood ow 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 SpO
2
will decrease. In this case, the
measurement will be more sensitive to interference.
B. The measurement will be inuenced by intravascular staining agents (such
as indocyanine green or methylene blue), skin pigmentation.
C. 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.
D. Pulse oxygen only has a reference meaning for anemia and toxic hypoxia,
as some severe anemia patients still show better pulse oxygen measured
values.
E. Contraindication: no
FINGERTIP PULSE OXIMETER COMPONENTS
INSTALLING BATTERIES IN YOUR PULSE OXIMETER
ATTACHING THE LANYARD TO THE PULSE OXIMETER
MEASURING PULSE RATE AND BLOOD OXYGEN LEVELS
Optical sensor
Red light Wavelength: about 660 nm, optical output power: < 6.65 mW
Infrared light Wavelength: about 905 nm, optical output power: < 6.75 mW
Safety class Internally powered equipment, type BF applied part
International
Protection
IP22
Working voltage DC 2.6 V - 3.6 V
Working current 25 mA
Power supply DC 3V (2 x AAA batteries)
Battery life Two batteries can work continually for approximately 24 hours
Dimension
2.2”(L) x 1.2”(W) x 1.3”(H)
57mm(L) x 31mm(W) x 32mm(H)
Weight About 1.8oz /51g (including batteries)
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.
© 2021 Sunbeam Products, Inc. All rights reserved.
Distributed by Star Elite Inc., Montreal, Canada H3B 3X9.
SE004-071421
Fingertip Pulse Oximeter Model CMS50DL
Printed in China
Model : CMS50DL
Item: 16979
Figure 3.
Batteries Installation
Power Button
SpO
²
Display
Battery Level Indicator
Pulse Rate BPM (beats per minute)
Pulse Rate Bar Graph
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Summary

General Safety and Warnings

Crucial Safety Precautions

Essential warnings and precautions for safe and effective use of the pulse oximeter.

Product Overview and Application

Device Overview

Explanation of oxygen saturation and its physiological significance.

Intended Use and Range

Defines the pulse oximeter's application for spot-checking adults in home environments.

Environmental Requirements

Specifies storage and operation conditions for temperature, humidity, and pressure.

Usage Guidelines and Technical Details

Important User Considerations

Instructions on device handling, acclimatization, and factors impacting measurement accuracy.

Clinical Restrictions and Influences

Identifies conditions and substances that affect oximeter readings and clinical interpretation.

Technical Specifications

Details the optical sensor, power, dimensions, weight, and safety class of the device.

Device Operation and Measurement

Pulse Oximeter Principle and Components

Explains the operating principle and identifies the key components of the device.

Battery and Lanyard Setup

Instructions for installing batteries and attaching the lanyard for device use.

Measurement Procedure

Step-by-step guide on how to correctly measure pulse rate and blood oxygen levels.

Results, Maintenance, and Troubleshooting

Interpreting Measurement Results

Details the display ranges, accuracy, and resolution for SpO2 and Pulse Rate measurements.

Cleaning and Storage Instructions

Procedures for cleaning, disinfecting, and storing the pulse oximeter for longevity.

Disposal, Warranty, and FAQs

Information on device disposal, warranty coverage, and answers to common troubleshooting questions.

Symbols, Declarations, and RF Guidelines

Key Device Symbols

Explanation of symbols used on the device and in the instruction manual.

EMC Declaration and Guidance

Information regarding electromagnetic compatibility and environmental considerations.

RF Emissions and Immunity

Guidance on electromagnetic emissions and immunity compliance for the device.

Recommended RF Separation Distances

Guidelines for maintaining safe distances from RF communication equipment to prevent interference.

Summary

General Safety and Warnings

Crucial Safety Precautions

Essential warnings and precautions for safe and effective use of the pulse oximeter.

Product Overview and Application

Device Overview

Explanation of oxygen saturation and its physiological significance.

Intended Use and Range

Defines the pulse oximeter's application for spot-checking adults in home environments.

Environmental Requirements

Specifies storage and operation conditions for temperature, humidity, and pressure.

Usage Guidelines and Technical Details

Important User Considerations

Instructions on device handling, acclimatization, and factors impacting measurement accuracy.

Clinical Restrictions and Influences

Identifies conditions and substances that affect oximeter readings and clinical interpretation.

Technical Specifications

Details the optical sensor, power, dimensions, weight, and safety class of the device.

Device Operation and Measurement

Pulse Oximeter Principle and Components

Explains the operating principle and identifies the key components of the device.

Battery and Lanyard Setup

Instructions for installing batteries and attaching the lanyard for device use.

Measurement Procedure

Step-by-step guide on how to correctly measure pulse rate and blood oxygen levels.

Results, Maintenance, and Troubleshooting

Interpreting Measurement Results

Details the display ranges, accuracy, and resolution for SpO2 and Pulse Rate measurements.

Cleaning and Storage Instructions

Procedures for cleaning, disinfecting, and storing the pulse oximeter for longevity.

Disposal, Warranty, and FAQs

Information on device disposal, warranty coverage, and answers to common troubleshooting questions.

Symbols, Declarations, and RF Guidelines

Key Device Symbols

Explanation of symbols used on the device and in the instruction manual.

EMC Declaration and Guidance

Information regarding electromagnetic compatibility and environmental considerations.

RF Emissions and Immunity

Guidance on electromagnetic emissions and immunity compliance for the device.

Recommended RF Separation Distances

Guidelines for maintaining safe distances from RF communication equipment to prevent interference.

Overview

The Sunbeam Fingertip Pulse Oximeter, Model CMS50DL (Item: 16979), is a non-invasive device designed for the spot-check of arterial hemoglobin oxygen saturation (SpO2) and pulse rate (PR) in adults within home use environments. It is specifically intended for use during sporting and aviation activities to monitor heart rate during exercise, and is not suitable for continuous monitoring or clinical diagnosis.

Function Description:

The pulse oximeter operates based on the Lambert-Beer Law and the Spectrum Absorption Characteristics of Reductive Hemoglobin (Hb) and Oxyhemoglobin (HbO2) in glow and near-infrared zones. It employs Photoelectric Oxyhemoglobin Inspection Technology and Capacity Pulse Scanning & Recording Technology. Two beams of light with different wavelengths are focused onto the human fingertip through a clamp-type sensor. A photosensitive element then obtains the measured signal, which is processed by electronic circuits and a microprocessor to display the SpO2 and pulse rate on the screen. The device is calibrated to display functional oxygen saturation.

Important Technical Specifications:

  • Optical Sensor:
    • Red light: Wavelength about 660 nm, optical output power < 6.65 mW.
    • Infrared light: Wavelength about 905 nm, optical output power < 6.75 mW.
  • Safety Class: Internally powered equipment, type BF applied part.
  • International Protection: IP22.
  • Working Voltage: DC 2.6 V - 3.6 V.
  • Working Current: ≤ 25 mA.
  • Power Supply: DC 3V (2 x AAA batteries).
  • Battery Life: Two batteries can work continually for approximately 24 hours.
  • Dimension: 2.2"(L) x 1.2"(W) x 1.3"(H) / 57mm(L) x 31mm(W) x 32mm(H).
  • Weight: About 1.8oz/51g (including batteries).
  • SpO2 Display Range: 0% - 99%.
  • SpO2 Measured Range: 0% - 100%.
  • SpO2 Accuracy: 70% - 100%: ±2%; 0% - 69%: unspecified.
  • SpO2 Resolution: 1%.
  • Pulse Rate (PR) Display Range: 30 - 250 beats/minute.
  • Pulse Rate (PR) Measured Range: 30 - 250 beats/minute.
  • Pulse Rate (PR) Accuracy: ±2 beats/minute or ±2%, whichever is greater.
  • Pulse Rate (PR) Resolution: 1 beat/minute.
  • Accuracy under Low Perfusion (0.4%): SpO2: ±4%; Pulse Rate: ±2 beats/minute or ±2%, whichever is greater.
  • Light Interference: Under normal and ambient light conditions, SpO2 deviation ≤ 1%.

Environmental Requirements:

  • Storage Environment:
    • Temperature: -40°F - 140°F (-40°C - 60°C).
    • Relative humidity: ≤ 95%.
    • Atmospheric pressure: 500 hPa - 1060 hPa.
  • Operation Environment:
    • Temperature: 50°F - 104°F (10°C - 40°C).
    • Relative Humidity: ≤ 75%.
    • Atmospheric pressure: 700 hPa - 1060 hPa.

Usage Features:

  • Components: The device features a Power Button, SpO2 Display, Battery Level Indicator, Pulse Rate BPM (beats per minute) display, and a Pulse Rate Bar Graph.
  • Battery Installation: Requires 2 AAA batteries. Users should slide open the back cover, align batteries with "+" and "-" symbols, and replace the cover.
  • Lanyard Attachment: A thin connector loop can be threaded through a hole on the device, and a quick-release buckle inserted through the loop, with the lanyard clip then sliding into the buckle.
  • Measurement Procedure:
    1. Warm hands and fingers by rubbing them together, as low blood perfusion and cold extremities can affect readings.
    2. Gently squeeze to open the finger chamber.
    3. Place a finger fully into the chamber.
    4. Press the ON button.
    5. Keep the hand and finger still during measurement to avoid affecting readings.
    6. Allow at least 30 seconds for the measurement to stabilize.
    7. Nail polish and artificial fingernails may cause false or no results.
  • Automatic Power-Off: The device enters energy-saving mode and turns off if not in use for several seconds.
  • Clinical Restrictions:
    • Requires substantial pulsating blood flow; weak pulse due to shock, low ambient/body temperature, major bleeding, or vasoconstricting drugs may decrease SpO2 readings and increase sensitivity to interference.
    • Measurements can be influenced by intravascular staining agents (e.g., indocyanine green, methylene blue) and skin pigmentation.
    • Normal-seeming values may occur in users with anemia or dysfunctional hemoglobin (e.g., carboxyhemoglobin, methemoglobin, sulfhemoglobin), who may still be hypoxic. Further assessment is recommended.
    • Pulse oxygen values are for reference only in cases of anemia and toxic hypoxia.
    • Contraindication: None.

Maintenance Features:

  • Cleaning & Disinfecting:
    1. Remove batteries before cleaning.
    2. Wipe the finger chamber and exterior surface with a disinfecting solution of at least 75% isopropyl alcohol.
    3. Do not immerse in water or liquid, or spray liquid directly onto the device.
    4. Allow to air-dry or wipe dry with a clean, soft cloth.
    5. HIGH-PRESSURE STERILIZATION CANNOT BE USED.
  • Storage:
    1. Store in a dry, well-ventilated location away from extreme temperatures, moisture, heat, lint, dust, and direct sunlight.
    2. Do not place heavy objects on the oximeter.
    3. Remove batteries before extended storage or when not in use.
    4. Ensure the device is clean and dry before storage.
  • Regular Inspection: Inspect the device regularly for visible damage. Discontinue use if damage is noticed.
  • Battery Replacement: Replace batteries when the low-battery indicator appears or if the device does not turn on. Only use recommended batteries; do not use rechargeable batteries.
  • Disposal: Dispose of/recycle the device and used batteries according to local regulations to avoid environmental pollution. Do not discard in household trash or fire.

Warnings and Precautions:

  • Explosive Hazard: Do not use in environments with inflammable gas (e.g., anesthetic).
  • MRI/CT Scan: Do not use during MRI or CT scans due to potential burns from induced currents.
  • Clinical Diagnosis: Information displayed is not a sole basis for clinical diagnosis and is not a replacement for professional medical advice.
  • Continuous Monitoring: Not recommended for continuous monitoring.
  • Finger Condition: Do not use on fingertips with scar tissue or other skin disorders, as this may affect measurement accuracy.
  • Infrared Light: Do not stare directly into the finger chamber when the device is on, as infrared light may damage eyes.
  • Biocompatibility: Contains silicone, PVC, TPU, TPE, and ABS materials. Biocompatibility tested per ISO 10993-1. Do not use if allergic to these materials.
  • Lanyard: Do not use the included lanyard if allergic to nylon/polyester. Do not wrap the lanyard around the neck to avoid accidents.
  • Children/Pets: Keep out of reach of children/pets.
  • Battery Safety: Do not throw batteries into fire or discard in household trash.
  • Device Integrity: Do not drop, disassemble, or modify the device. Discontinue use if damaged or unusual.
  • Sensitive Components: Handle with caution. Observe cleaning, maintenance, and operating conditions.
  • In-Use Service: Do not perform service or maintenance while the device is in use.
  • Battery Contact: Do not touch the battery and the person at the same time.
  • Damaged Device: Do not use if damaged, degraded, or loosened. Continuous use of a damaged device may cause injury, improper results, or serious danger.
  • Environmental Changes: If ambient temperature changes significantly, allow the device to remain in the room for 30 minutes before use.
  • Water Exposure: Do not use if splashed by or immersed in water.
  • Sterilization: High temperature, high pressure, gas sterilizing, or immersion disinfection are not permitted.
  • User Suitability: May not be suitable for all users. Measurement results are for reference only.
  • Data Averaging: Data averaging and signal processing have a delay. For update periods less than 30 seconds, the time for obtaining dynamic average values will increase.
  • External Coloring Agents: Do not use nail polish, artificial nails, or colored skin care products on the test finger, as this may affect accuracy.
  • Test Finger Condition: Measurement accuracy may be impacted if the finger is too cold, too thin (try a larger finger), or has a long fingernail (trim or switch to a short-nailed finger).
  • Finger Position: Refer to the manual for correct finger position to avoid inaccurate results.
  • Optical Path: Ensure the optical path between the photoelectric receiving tube and light-emitting tube is free from obstacles (e.g., rubberized fabric) to avoid inaccurate results.
  • Ambient Light: Excessive ambient light (surgical lights, xenon lamps, fluorescent lamps, infrared heaters, direct sunlight) may affect results. Place the sensor properly and cover it with opaque material to prevent interference.
  • Placement Restrictions: Do not place on a limb with a blood pressure cuff, arterial ductus, or intraluminal tube.
  • Defibrillation: Measured values may be inaccurate during and shortly after defibrillation, as the device lacks a defibrillation function.
  • Calibration: The device is factory-calibrated to display functional oxygen saturation.

Sunbeam CMS50DL Specifications

General IconGeneral
BrandSunbeam
ModelCMS50DL
CategoryMedical Equipment
LanguageEnglish