Contec CMS50D - User Manual

Instructions to User
Dear Users, thank you very much for purchasing our product.
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and
harmonized standards. The Manual is written for the current Pulse Oximeter. In case of modifications and software upgrades, the
information contained in this document is subject to change without notice.
The Manual describes, in accordance with the Pulse Oximeter's features and requirements, main structure, functions,
specifications, correct methods for transportation, installation, usage, operation, repair, maintenance and storage, etc. as well as
the safety procedures to protect both the user and equipment. Refer to the respective chapters for details.
Please read the Manual very carefully before using this equipment. These instructions describe the operating procedures to be
followed strictly, failure to follow these instructions can cause measuring abnormality, equipment damage and personal injury.
The manufacturer is NOT responsible for the safety, reliability and performance issues and any monitoring abnormality, personal
injury and equipment damage due to user's negligence of the operation instructions. The manufacturer’s warranty service does not
cover such faults.
Owing to the forthcoming renovation, the specific products you received may not be totally in accordance with the description of
this User Manual. We would sincerely regret for that.
This product is medical device, and can be used repeatedly. Its using life is 3 years.
WARNING:
 The uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the microcirculation
barrier patients. It is recommended that the sensor should not be applied to the same finger for over 2 hours.
 For the individual patients, there should be a more prudent inspecting in the placing process. The device can not be
clipped on the edema and tender tissue.
 The light (the infrared is invisible) emitted from the device is harmful to the eyes, so the user and the maintenance
man, can not stare at the light.
 Testee can not use enamel or other makeup.
 Testee’s fingernail can not be too long.
 Please peruse the relative content about the clinical restrictions and caution.
 This device is not intended for treatment.
Caution: Federal law restricts this device to sale by or on the order of a physician.
1 Safety
1.1 Instructions for Safe Operations

Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect patient's
safety and monitoring performance about cables and transducers. It is recommended that the device should be inspected
once a week at least. When there is obvious damage, stop using the monitor.

Necessary maintenance must be performed by qualified service engineers ONLY. Users are not permitted to maintain it by
themselves.

The oximeter cannot be used together with devices not specified in User's Manual.Only the accessory that appointed or
recommendatory by manufacture can be used with this device.

This product is calibrated before leaving factory.
1.2 Warnings
 Explosive hazard—DO NOT use the oximeter in environment with inflammable gas such as some ignitable anesthetic
agents.
 DO NOT use the oximeter while the testee measured by MRI and CT.
 The person who is allergic to rubber can not use this device.
 The disposal of scrap instrument and its accessories and packings(including battery, plastic bags, foams and paper boxes)
should follow the local laws and regulations.
 Please check the packing before use to make sure the device and accessories are totally in accordance with the packing list,
or else the device may have the possibility of working abnormally.
 Please don't measure this device with function test paper for the device's related information.
1.3 Attentions
 Keep the oximeter away from dust, vibration, corrosive substances, explosive materials, high temperature and moisture.
 If the oximeter gets wet, please stop operating it.
 When it is carried from cold environment to warm or humid environment, please do not use it immediately.
 DO NOT operate keys on front panel with sharp materials.
 High temperature or high pressure steam disinfection of the oximeter is not permitted. Refer to User Manual in the relative
chapter for instructions of cleaning and disinfection.
 Do not have the oximeter immerged in liquid. When it needs cleaning, please wipe its surface with medical alcohol by soft
material. Do not spray any liquid on the device directly.
 When cleaning the device with water, the temperature should be lower than 60℃.
 As to the fingers which are too thin or too cold, it would probably affect the normal measure of the patients' SpO
2
and pulse
rate, please clip the thick finger such as thumb and middle finger deeply enough into the probe.
 Do not use the device on infant or neonatal patients.
 The product is suitable for children above four years old and adults (Weight should be between 15kg to 110kg).
 The device may not work for all patients. If you are unable to achieve stable readings, discontinue use.
 The update period of data is less than 5 seconds, which is changeable according to different individual pulse rate.
 The waveform is normalized.Please read the measured value when the waveform on screen is equably and steady-going,
Here this measured value is optimal value. And the waveform at the moment is the standard one.
 If some abnormal conditions appear on the screen during test process, pull out the finger and reinsert to restore normal use.
 The device has normal useful life for three years since the first electrified use.
 The hanging rope attached the product is made from Non- allergy material, if particular group are sensitive to the hanging
rope, stop using it. In addition, pay attention to the use of the hanging rope , do not wear it around the neck avoiding cause
harm to the patient.
 The instrument dose not have low-voltage alarm function, it only shows the low-voltage.please change the battery when
the battery energy is used out.
 When the parameter is particularly, The instrument dose not have alarm function.Do not use the device in situations where
alarms are required.
 Batteries must be removed if the device is going to be stored for more than one month, or else batteries may leak.
 A flexible circuit connects the two parts of the device. Do not twist or pull on the connection.
1.4 Indication for Use
The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin
(SpO
2
) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in
internist/surgery, anesthesia, intensive care ect.). This device is not intended for continuous monitoring.
2 Overview
The pulse 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 bio-parameter for the respiration. For the purpose of measuring the SpO
2
more easily and accurately, our company
developed the Pulse Oximeter. At the same time, the device can measure the pulse rate simultaneously.
The Pulse Oximeter features in small volume, low power consumption, convenient operation and being portable. It is only
necessary for patient to put one of his fingers into a fingertip photoelectric sensor for diagnosis, and a display screen will directly
show measured value of Hemoglobin Saturation.
2.1 Classification
Class II b, (MDD93/42/EEC IX Rule 10)
2.2 Features
 Operation of the product is simple and convenient.
 The product is small in volume, light in weight (total weight is about 50g including batteries) and convenient in carrying.
 Power consumption of the product is low and the two originally equipped AAA batteries can be operated continuously for
20 hours.
 The product will automatically be powered off when no signal is in the product within 5 seconds.
 4 directions display mode without waveform.
 Waveform display mode as line drawing or filling manner.
2.3 Major Applications and Scope of Application
The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through finger, and indicate the pulse
intensity by the bar-display. The product is suitable for use in family, hospital (Ordinary sickroom), Oxygen Bar, social medical
organizations and also the measure of saturation oxygen and pulse rate.
The product is not suitable for use in continuous supervision for patients.
The problem of overrating would emerge when the patient is suffering from toxicosis which caused by carbon
monoxide, the device is not recommended to be used under this circumstance.
2.4 Environment Requirements
Storage Environment
a) Temperature: -40℃~+60℃
b) Relative humidity: ≤95%
c) Atmospheric pressure: 500hPa~1060hPa
Operating Environment
a) Temperature: 10℃~40℃
b) Relative Humidity: ≤75%
c) Atmospheric pressure: 700hPa~1060hPa
3 Principle and Caution
3.1 Principle of Measurement
Principle of the 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 (HbO
2
) in glow &
near-infrared zones. Operation principle of the instrument 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.
Figure 1 Operating principle
3.2 Caution
1. The finger should be placed properly (see the attached illustration of this manual, Figure 5), or else it may cause inaccurate
measurement.
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. The SpO
2
sensor should not be used at a location or limb tied with arterial canal or blood pressure cuff or receiving
intravenous injection.
4. Make sure the optical path is free from any optical obstacles like rubberized fabric.
5. Excessive ambient light may affect the measuring result. It includes fluorescent lamp, dual ruby light, infrared heater, direct
sunlight and etc.
6. Strenuous action of the subject or extreme electrosurgical interference may also affect the accuracy.
7. Testee can not use enamel or other makeup.
3.3 Clinical Restrictions
1. As the measure is taken on the basis of arteriole pulse, substantial pulsating blood flow of subject is required. For a subject
with weak pulse due to shock, low ambient/body temperature, major bleeding, or use of vascular contracting drug, the SpO
2
waveform (PLETH) will decrease. In this case, the measurement will be more sensitive to interference.
2. For those with a substantial amount of staining dilution drug (such as methylene blue, indigo green and acid indigo blue), or
carbon monoxide hemoglobin (COHb), or methionine (Me+Hb) or thiosalicylic hemoglobin, and some with icterus problem,
the SpO
2
determination by this monitor may be inaccurate.
3. The drugs like dopamine, procaine, prilocaine, lidocaine and butacaine may also be a major factor blamed for serious error of
SpO
2
measure.
4. As the SpO
2
value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some patients with serious
anemia may also report good SpO
2
measurement.
4 Technical Specifications
1) Display Format: OLED Display;
SpO
2
Measuring Range: 0% ~ 100%;
Pulse Rate Measuring Range: 30 bpm ~ 250 bpm;
Pulse Wave Display: columniation display and the waveform display.
2) Power Requirements: 2×1.5V AAA alkaline battery (or using the rechargeable battery instead), adaptable range:
2.6V~3.6V.
3) Power Consumption: Smaller than 30mA.
4) Resolution: 1% for SpO
2
and 1 bpm for Pulse Rate.
5) Measurement Accuracy: ±2% in stage of 70%-100% SpO
2
, and meaningless when stage being smaller than 70%. ±2 bpm
during the pulse rate range of 30-99 bpm and ±2% during the pulse rate range of 100~250 bpm .
6) Measurement Performance in Weak Filling Condition: SpO
2
and pulse rate can be shown correctly when pulse-filling
ratio is 0.4%. SpO
2
error is ±4%, pulse rate error is ± 2 bpm during the pulse rate range of 30~99 bpm and ±2% during the
pulse rate range of 100~250 bpm .
7) Resistance to surrounding light: The deviation between the value measured in the condition of man-made light or indoor
natural light and that of darkroom is less than ±1%.
8) It is equipped with a function switch. The Oximeter can be powered off in case no finger is the Oximeter within 5 seconds.
9) Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)
5 Accessories
 One hanging rope;
 Two batteries(optional)
 One User Manual.
6 Installation
6.1 View of the Front Panel
Figure 2 Front view Figure 3 Batteries installation Figure 4 Mounting the hanging rope
6.2 Battery
Step 1. Refer to Figure 3. and insert the two AAA size batteries properly in the right direction.
Step 2. Replace the cover.
Please take care when you insert the batteries for the improper insertion may damage the device.
6.3 Mounting the Hanging Rope
Step 1. Put the end of the rope through the hole.
Step 2. Put another end of the rope through the first one and then tighten it.
7 Operating Guide
1) Insert the two batteries properly to the direction, and then replace the cover.
2) Open the clip as shown in Figure 5.
Figure 5 Put finger in position
3) Let the patient’s finger put into the rubber cushions of the clip (make sure the finger is in the right position), and then clip
the finger.
4) Press the switch button once on front panel.
5) Do not shake the finger and keep the patient at ease during the process. Meanwhile, human body is not recommended in
movement status.
6) Get the information directly from screen display.
7) The button has three functions.When the device is power off, pressing the button can open it; When the device is
power on, pressing the button shortly can change direction of the screen; When the device is power on, pressing the button
long can change brightness of the screen.
Press the button shortly when the device is power on, the display mode will change, show as follow figure:
All manuals and user guides at all-guides.com
all-guides.com

Summary

Instructions to User

Safety Warnings and Precautions

Critical safety precautions and potential hazards associated with the device's use.

Regulatory Restriction

Legal restriction on device distribution and sale as mandated by federal law.

Safety Information

Safe Operation Guidelines

Guidelines for safe operation, including checks and maintenance procedures to ensure user and equipment safety.

General Warnings

Lists potential hazards and contraindications for using the pulse oximeter.

Operational Attentions

Details specific operational precautions and environmental considerations for optimal device performance.

Intended Use

Defines the intended medical purpose and scope of application for the pulse oximeter.

Product Overview

Device Classification

Specifies the device's classification under medical device directives for regulatory purposes.

Key Features

Highlights key operational features and design characteristics of the pulse oximeter.

Applications and Scope

Outlines the primary applications and suitable environments for using the pulse oximeter.

Environmental Requirements

Specifies the required temperature, humidity, and pressure for storage and operation.

Measurement Principle and Cautions

Principle of Measurement

Explains the underlying scientific principle and technology used for measuring SpO2 and pulse rate.

General Cautions

Provides crucial cautions regarding ambient light, patient movement, and testee preparation for accurate readings.

Clinical Restrictions

Details clinical limitations, factors affecting accuracy, and specific patient conditions to consider.

Technical Specifications

Display and Measurement Ranges

Specifies display type, SpO2 and pulse rate measurement ranges, and pulse wave visualization.

Power Requirements

Details power source requirements, including battery type and voltage adaptability.

Power Consumption

States the device's power consumption rate during operation.

Measurement Resolution

Defines the precision level for SpO2 and pulse rate measurements.

Measurement Accuracy

Outlines the accuracy specifications for SpO2 and pulse rate measurements.

Performance in Weak Filling

Describes performance under low pulse-filling conditions and associated accuracy.

Resistance to Ambient Light

Details the device's resistance to ambient light interference affecting measurement accuracy.

Automatic Power Off

Mentions the auto-power-off function triggered by the absence of a finger.

Optical Sensor Specifications

Provides specifications for the optical sensor, including light wavelengths and power.

Accessories and Installation

Included Accessories

Lists the items included with the pulse oximeter package.

Front Panel View

Identifies and describes the components visible on the front panel of the device.

Battery Installation

Step-by-step instructions for correctly inserting batteries into the device.

Hanging Rope Installation

Instructions on how to attach the hanging rope to the pulse oximeter.

Operating Guide

Device Operation Steps

Detailed steps for operating the pulse oximeter from battery insertion to reading display.

Button Functions

Explains the multiple functions of the device's button for power, screen direction, and brightness.

Display Mode Changes

Describes how to change the screen display mode using the device's button.

Troubleshooting and Symbols

Troubleshooting Common Issues

Provides solutions for common problems encountered during device operation.

Key Symbol Definitions

Explains the meaning of various symbols used on the device and in the manual.

Electromagnetic Compatibility (EMC)

EMC Immunity Guidance

Guidance for ensuring immunity to electromagnetic disturbances in various environments.

EMC Emission Guidance

Guidance on electromagnetic emissions for equipment and systems.

Recommended Separation Distances

Provides recommended distances for portable and mobile RF communication equipment.

Function Specification

Display Information

Details the information displayed on the oximeter screen.

SpO2 Parameter Specifications

Technical specifications for measuring Oxygen Saturation (SpO2).

Pulse Parameter Specifications

Technical specifications for measuring Pulse Rate (PR).

Pulse Intensity

Details the specifications for pulse intensity indication.

Battery and Display Requirements

Specifies battery requirements and display mode capabilities.

Dimensions and Weight

Provides the physical dimensions and weight of the pulse oximeter.

Overview

1. Function Description
2. Usage Features
3. Maintenance Features

The CONTEC CMS50D Pulse Oximeter is a non-invasive medical device designed for spot-checking oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in both adults and pediatric patients. It is suitable for use in various environments, including homes and hospitals (such as in internist/surgery, anesthesia, and intensive care settings). This device is not intended for continuous monitoring.

Function Description

The Pulse Oximeter measures the percentage of oxyhemoglobin (HbO2) in the total hemoglobin in the blood, which is referred to as O2 concentration or SpO2. This is a crucial bio-parameter for respiration. Simultaneously, the device also measures the pulse rate. The operating principle is based on the Lambert-Beer Law, utilizing the spectrum absorption characteristics of deoxyhemoglobin (Hb) and oxyhemoglobin (HbO2) in the red and near-infrared light spectrums. It employs Photoelectric Oxyhemoglobin Inspection Technology and Capacity Pulse Scanning & Recording Technology. Two beams of different wavelengths are focused onto the human fingertip through a clamp-type sensor. The measured signal is then processed by a photosensitive element and displayed on the screen after electronic circuit and microprocessor treatment. The device indicates pulse intensity through a bar display.

Usage Features

The CMS50D Pulse Oximeter is characterized by its small volume, light weight (approximately 50g including batteries), and portability, making it convenient for users. Operation is straightforward: the patient simply places one finger into the fingertip photoelectric sensor for diagnosis, and the measured hemoglobin saturation and pulse rate values are directly shown on the display screen.

The device is powered by two 1.5V AAA alkaline batteries (or rechargeable batteries) and has low power consumption, allowing for continuous operation for up to 20 hours with the originally equipped batteries. It features an automatic power-off function, activating when no signal is detected within 5 seconds. The display offers four direction modes without a waveform, and the waveform can be shown as either a line drawing or a filling manner.

For accurate measurements, the finger must be positioned correctly within the sensor. The SpO2 sensor and photoelectric receiving tube should be aligned with the subject's arteriole. It is crucial to avoid using the sensor on a location or limb with an arterial canal, blood pressure cuff, or receiving intravenous injection. The optical path must be clear of any obstructions, such as rubberized fabric. Excessive ambient light (fluorescent lamps, dual ruby lights, infrared heaters, direct sunlight) and strenuous subject movement or electrosurgical interference can affect measurement accuracy. Patients should not wear enamel or other makeup on their fingernails during use.

The device is suitable for children above four years old and adults, with a weight range of 15kg to 110kg. It may not work for all patients, and if stable readings cannot be achieved, use should be discontinued. The data update period is less than 5 seconds, varying with the individual pulse rate. The displayed waveform is normalized, and the measured value is considered optimal when the waveform on the screen is steady and even. If abnormal conditions appear during testing, the finger should be removed and reinserted to restore normal operation.

The device has a normal useful life of three years from its first use. A hanging rope made from non-allergy material is provided; users sensitive to the rope should discontinue its use. Care should be taken not to wear the rope around the neck to avoid harm. The instrument does not have a low-voltage alarm function but indicates low voltage, prompting battery replacement when energy is depleted. It also lacks an alarm function for specific parameters, so it should not be used in situations where alarms are required.

Maintenance Features

Regular checks of the main unit and all accessories are recommended to ensure no visible damage that could affect patient safety or monitoring performance, particularly regarding cables and transducers. It is advised to inspect the device at least once a week. If obvious damage is present, the monitor should be stopped from use.

Maintenance should only be performed by qualified service engineers; users are not permitted to maintain the device themselves. Only accessories appointed or recommended by the manufacturer should be used with the device. The product is calibrated before leaving the factory.

For cleaning, the surface of the device should be wiped with medical alcohol and then allowed to air dry or cleaned with a dry fabric. Disinfecting the product with medical alcohol after use helps prevent cross-infection. The device should not be immersed in liquid, and high-pressure steam disinfection is not permitted. When cleaning with water, the temperature should be below 60°C.

Batteries should be removed if the device is to be stored for more than one month to prevent leakage. The best storage environment for the device is an ambient temperature of -40°C to +60°C and relative humidity not higher than 95%. Users are advised to calibrate the device periodically (or according to hospital calibration programs), which can be done through a state-appointed agent or by contacting the manufacturer. The device should be kept in a dry environment, as humidity can reduce its useful life or even damage it.

Contec CMS50D Specifications