Contec pulse oximeter cms50dl инструкция

CMS50DL1 Pulse Oximeter
User Manual

Instructions to User

Instructions to User
Dear users, thank you very much for purchasing the Pulse Oximeter (hereinafter referred to as device).
This Manual is written and compiled in accordance with the council directive MDD93/42/EEC for medical devices and harmonized standards. In case of modifications and software upgrades, the information contained in this document is subject to change without notice.
It is a medical device, which can be used repeatedly.
The Manual describes, in accordance with the device’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 device. Refer to the respective chapters for details.
Please read the User Manual carefully before using this device. The User Manual which describes the operating procedures should be followed strictly. Failure to follow the User Manual may cause measuring abnormality, device damage, and human injury. The manufacturer is NOT responsible for the safety, reliability and performance issues and any monitoring abnormality, human injury, and device damage due to users’ negligence of the operating 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.
Our company has the final interpretation to this manual. The content of this manual is subject to change without prior notice.
Warnings
Remind that it may cause serious consequences to the tester, user or environment.

Explosive hazard—DO NOT use the device in an environment with inflammable gas such as an anesthetic.
DO NOT use the device while examining by MRI or CT, as the induced current may cause burn.
Do not take the information displayed on the device as the sole basis for clinical diagnosis. The device is only used as an auxiliary means in diagnosis. And it must be used in conjunction with the doctor’s advice, clinical manifestations and symptoms.
The maintenance to the device. Users are not permitted to maintain or refit the device by themselves.
The uncomfortable or painful feelings may appear if using the device ceaselessly, especially for microcirculation disturbance users. It is not recommended that the sensor is used on the same finger for more than 2 hours.
For some special users who need a more careful inspection on the test site, please don’t place the device on the edema or tender tissue.
Please do not stare at the red and infrared light emitter (the infrared light is invisible) after turning on the device, including the maintenance staff, as it may be harmful to the eyes.
The 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. The person who is allergic to silicone, PVC, TPU, TPE or ABS can not use this device.
Do NOT strand the lanyard to avoid device drop and damage. The lanyard is made of insensitive material. Please do not use it if any person is allergic to lanyards. Do not wrap the lanyard around the neck to avoid an accident.
The disposal of scrap devices, its accessories, and packaging should follow the local laws and regulations, to avoid polluting to the local environment. And the packaging materials must be placed in the region where the children are out of reach.
The device can not be used with the equipment not specified in the Manual. Only the accessories appointed or recommended by the manufacturer can be used, otherwise, it may cause injury to the tester and operator or damage to the device.
Check the device before use to make sure that there is no visible damage that may affect the user’s safety and device performance. When there is obvious damage, please replace the damaged parts before use.
Functional testers can not be used to assess the accuracy of the Pulse Oximeter.
Some functional testers or patient simulators can be used to verify whether the device works normally, for example, INDEX-2LFE Simulator (software version: 3.00), please refer to the Manual for the detailed operation steps.
Some functional testers or patient simulators can measure the accuracy of the device copied calibration curve, but they can not be used to evaluate the device’s accuracy.
When using the device, please keep it away from the equipment which can generate a strong electric field or strong magnetic field. Using the device in an inappropriate environment may cause interference to the surrounding radio equipment or affect its working.
The measured accuracy will be affected by the interference of electrosurgical equipment.
When several products are used on the same patient simultaneously, danger may occur which is arisen from the overlap of leakage current.
CO poisoning will appear excessive estimation, so it is not recommended to use the device.
This device is not intended for treatment.
The intended operator of the device may be a patient.
Avoid maintaining the device during use.

Overview

The oxygen saturation is the percentage of HbO2 in the total Hb in the blood, so-called the O2 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 the decrease of SpO2 in the blood, furthermore, some other causes such as the malfunction of human body’s self-adjustment, damages during surgery, and the injuries caused by some medical checkup would also lead to the difficulty of oxygen supply in human body, and the corresponding symptoms would appear as a consequence, such as vertigo, impotence, vomit etc. Serious symptoms might bring danger to human’s life. Therefore, prompt information of patients’ SpO2 is of great help for the doctor to discover the potential danger, and is of great importance in the clinical medical field.
Insert the finger when measuring, the device will directly display the SpO2 value measured, it has a higher accuracy and repeatability.

1. Features
   A. Easy to use.
   B. Small in volume, light in weight, convenient to carry.
   C. Low power consumption.
2. Applied range
   The Pulse Oximeter can be used to measure human Hemoglobin Saturation and pulse rate through the finger, and indicate the pulse intensity by the bar display. The product is suitable for use in families, hospitals (Ordinary sickroom ), Oxygen bars, social medical organizations and also the measure of saturation oxygen and pulse rate.
3. Environment requirements
   Storage Environment
   a) Temperature: -40 ℃ ~ + 60 ℃
   b) Relative humidity: ≤ 95%
   c) Atmospheric pressure: 500 hPa ~ 1060 hPa
   Operating Environment
   a) Temperature: +10 ℃~ + 40 ℃
   b) Relative Humidity: ≤ 75%
   c) Atmospheric pressure: 700 hPa ~ 1060 hPa
4. Precautions
5. Attention

Point out conditions or practices that may cause damage to the device or other properties.

Before using the device, make sure that it locates in a normal working state and operating environment.
In order to get a more accurate measurement, it should be used in a quiet and comfortable environment.
When it is carried from a cold environment to a warm or humid environment, please do not use it immediately.
If the device is splashed or coagulated by water, please stop operating.
DO NOT operate the device with sharp things.
High temperature, high pressure, gas sterilizing, or immersion disinfection for the device is not permitted. Refer to User Manual in the relative chapter (6.1) for cleaning and disinfection..Please take out the internal battery before cleaning and disinfection.
The device is suitable for children and adults.
The device may not be suitable for all users, if you can’t get a satisfactory result, please stop using it.
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, which is arisen from signal degradation, low perfusion, or other interference, it depends on the PR value.
The device has a 3-year service life, date of manufacture: see the label.
The device hasn’t a low-voltage prompt function, it only shows the low-voltage, please change the battery when the battery voltage is used up.
The maximum temperature at the SpO2 probe-tissue interface should be less than 41℃ which is measured by the temperature tester.
During measuring, when abnormal conditions appear on the screen, please pull out your finger and reinsert it to measure again.
If some unknown error appears during measuring, remove the battery to terminate operating.
Do not contort or drag the wire of the device.
The plethysmographic waveform is not normalized, as a signal inadequacy indicator, when it is not smooth and stable, the accuracy of the measured value may degrade. When it tends to be smooth and stable, the measured value read is optimal and the waveform at this time is also the most standard.
If the device or component is intended for single-use, then the repeated use of these parts will pose risks on the parameters and technical parameters of the equipment known to the manufacturer.
If necessary, our company can provide some information (such as circuit diagrams, component lists, illustrations, etc.), so that the qualified technical personnel of the user can repair the device components designated by our company.
The measured results will be influenced by the external coloring agent (such as nail polish, coloring agent or color skincare products, etc.), so don’t use them on the test site.
As to the fingers which are too cold or too thin or whose fingernail is too long, it may affect the measured results, so please insert the thicker finger such as thumb or middle finger deeply enough into the probe when measuring.
The finger should be placed correctly (see Attached figure 5), as improper installation or improper contact position for the sensor will influence the measurement.
The light between the photoelectric receiving tube and the light-emitting tube of the 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.
Frequent movement (active or passive) of the subject or severe activity can affect the measurement accuracy.
The Pulse Oximeter should not be placed on a limb with the 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 has not defibrillation function.
The device has been calibrated before leaving the factory.
The device is calibrated to display functional oxygen saturation.
The equipment connected with the Oximeter interface should comply with the requirements of IEC 60601-1.

Clinical restriction

A. As the measure is taken on the basis of arteriole pulse, the substantial pulsating blood flow of the subject is required. For a subject with a weak pulse due to shock, low ambient/body temperature, major bleeding, or use of the vascular contracting drug, the SpO2 waveform (PLETH) will decrease. In this case, the measurement will be more sensitive to interference.
B. The measurement will be influenced by intravascular staining agents (such as indocyanine green or methylene blue), skin pigmentation.
C. The measured value may be normal seemingly for the tester who has anemia or dysfunctional hemoglobin(such as carboxyhemoglobin (COHb), methemoglobin (MetHb) and sulfhaemoglobin (SuHb)), but the tester may appear hypoxia, it is recommended to perform further assessment according to the clinical situations 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 valued.
E. Contraindication: no

Principle

Figure 1 Operating principle

The 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 (HbO2) 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.

Functions

A. SpO2 value display
B. PR value and bar graph display
C. Low-battery indication: low-battery indication appears when the battery voltage is
too low to work
D. Automatic standby function

Installation

View of the front panel

Battery
Step 1. Refer to Figure 3-1 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.
Sketch map for the back cover in ON/OFF state refer to Figure 3-2:

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.

Figure 4. Mounting the hanging rope.

Structure, accessories, and software description
A. Structure: main unit.
B. Accessories: one User Manual, one hanging rope.
Please check the device and accessories according to the list to avoid the device can not working normally.
C. Software description
Software name: CMS50DL embedded software
Software specification: no
Release version: V2.0
The naming rule for version: V <Major enhancive software upgrade>.<Minor enhancive software upgrade>.<Improvement software upgrade>
Involved algorithm: name: plethysmography; type: mature arithmetic
Purpose: be used to measure SpO2, pulse rate, etc.
Clinical function: calculate SpO2 and pulse rate values by collecting and processing the testee’s pulse signal.

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.
   
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 button once on the front panel.
5. Do not shake the finger and keep the patient at ease during the process. Meanwhile, the human body is not recommended in movement status.
6. Get the information directly from the screen display.
7. In the boot-strap state, press the button, and the device is reset.
   Fingernails and the luminescent tube should be on the same side.

Maintain, Transport and Storage

1. Cleaning and disinfection
   The device must be turned off before cleaning, and it should not be immersed into liquid.
   Please take out the internal battery before cleaning, do not immerse it into liquid.
   Use 75% alcohol to wipe the device enclosure, and use liquid soap or isopropanol to wipe the watchband for disinfection, nature dry or clean it with clean and soft cloth.
   Do not spray any liquid on the device directly, and avoid liquid penetrating into the device.
2. Maintenance
   A. Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect the patient’s safety and monitoring performance. It is recommended that the device should be inspected weekly at least. When there is obvious damage, stop using it.
   B. Please clean and disinfect the device before/after using it according to the User Manual (6.1).
   C. Please replace the batteries in time when low battery appears.
   D.Please take out the batteries if the device is not used for a long time.
   E. The device need not to be calibrated during maintenance.
3. Transport and Storage
   A. The packed device can be transported by ordinary conveyance or according to transport contract. During transportation, avoid strong shock, vibration and splashing with rain or snow, and it can not be transported mixed with toxic, harmful, corrosive material.
   B. The packed device should be stored in a room with no corrosive gases and good ventilation. Temperature: -40°C~+60°C; Relative humidity: ≤95%.

Troubleshooting

Key of Symbols

Symbol	Description
	Type BF
	Refer to instruction manual/booklet
%SpO2	The pulse oxygen saturation(%)
PRbpm	Pulse rate (bpm)
	The battery voltage indication is deficient (change the battery in time avoiding the inexact measure)
	1. No finger inserted 2. An indicator of signal inadequacy
	Battery positive electrode
	Battery cathode
	Exit standby mode
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
	European Representative
	This item is compliant with Directive 93/42/EEC of 14 june 1993 concerning medical devices; Including, at 21 March 2010, the amendments by Council Directive 2007/47/EEC.

Note： Your device may not contain all the following symbols.

Function Specification

Note 1: the claims of SpO2 accuracy shall be supported by clinical study measurements taken over the full range. By artificial inducing, get the stable oxygen level to the range of 70 % to 100 % SpO2, compare the SpO2 values collected by the secondary standard pulse oximeter equipment and the tested equipment at the same time, to form paired data, which are used for the accuracy analysis.
There are 12 healthy volunteers (male: 6. female: 6; age: 18~45; skin color: black: 2, light: 8, white: 2) data in the clinical report.
Note 2: because pulse oximeter equipment measurements are statistically distributed, only about two-thirds of pulse oximeter equipment measurements can be expected to fall within ±Arms of the value measured by a CO-OXIMETER.
Note 3: percentage modulation of the infrared signal as the indication of pulsating signal strength, the patient simulator has been used to verify its accuracy under conditions of low perfusion. SpO2 and PR values are different due to low signal conditions, compare them with the known SpO2 and PR values of the input signal.
Note 4: optical sensors as the light-emitting components, will affect other medical devices applied the wavelength range. The information may be useful for the clinicians who carry out the optical treatment. For example, photodynamic therapy is operated by the clinician.
Note 5: The patient simulator has been used to verify the pulse rate accuracy, it is stated as the root-mean-square difference between the PR measurement value and the value set by the simulator.

EMC
Note:

• 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 sources, as they can emit high-intensity electromagnetic radiation.
• Refer to the above chapters for the minimum value of the user’s physiological signal. The inaccurate result will appear when the device operates with values lower than the descriptions in the 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.
• The 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: SpO2 measured range: 70% ~ 100%, absolute error: ±2%; PR measured range: 30 bpm ~ 250 bpm, accuracy: ±2 bpm or ±2%, whichever is greater.

Appendix 1

Guidance and manufacturer’s declaration
Guidance and manufacture’s declaration – electromagnetic emissions- for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic immunity – for all EQUIPMENT and SYSTEMS

Guidance and manufacture’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING

Guidance and manufacture’s declaration — electromagnetic immunity
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of Pulse Chimerer should assure that it is used in such an environment.
Immunity test	1EC 60601 test level	Compliance level	Electromagnetic environment — guidance
Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3	3V(0.15MH z-80MHz), 6V(in ISM bands between 0.15MHz and 80MHz) 10 V/m 80 MHz to 2.7GH	3V(0.15MHz -80MHz),6V (in ISM bands between 0.15MHz and 80MHz) 10 V/m	Portable and mobile RF communications equipment should be used no closer to any part of the Pulse Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance 80 MHz to 800 MHz 800 MHz to 2.7 GHz Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 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 the Pulse Oximeter is used exceeds the applicable RF compliance level above, the Pulse Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the 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 is not LIFE-SUPPORTING

Recommended separation distances between portable and mobile RF communications equipment and the Pulse Oximeter.
The Pulse Oximeter is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Pulse Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Pulse Oximeter as recommended below, according to the maximum output power of the communications equipment.
	Separation distance according to the frequency of the transmitter(m)
Rated maximum output power of the transmitter (W)	150 kHz to 80 MHz	80 MHz to 800 MHz	800 MHz to 2.7 GI-1/
0.01	0.058	0.035	0.07
0.1	0.18	0.11	0.22
1	0.58	0.35	0.7
10	2.	1.10	2.
100	6.	4.	7
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people.

§ 15.19 Labeling requirements.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

§ 15.21 Information to the user.
Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
§ 15.105 Information to the user.
Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

Address: No.112 Qinhuang West Street, Economic ＆Technical
Development Zone, Qinhuangdao, Hebei Province, PEOPLE’S
REPUBLIC OF CHINA
Tel: +86-335-8015430
Fax: +86-335-8015588
Technical support:+86-335-8015431
E-mail: [email protected]
Website: http://www.contecmed.com
EC REPRESENTATIVE
Shanghai International Holding Corp. GmbH(Europe)
Address: Eiffestrasse 80, 20537, Hamburg, Germany
Tel: ＋49-40-2513175
Fax: ＋49-40-255726
E-mail: [email protected]
CMS2.782.179(CE.USA)ESS/1.9 1.4.01.01.701 2021.02

Documents / Resources

tags: 2ABOGCMS50DL1, CMS50DL1, CMS50DL1 Pulse Oximeter, Contec, Pulse Oximeter,

Contec Pulse Oximeter CMS50DL Manual

Instructions to User

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 User Manual carefully before using this product. The User Manual which describes the operating procedures should be followed strictly. Failure to follow the User Manual may cause measuring abnormality, equipment damage and human injury. The manufacturer is NOT responsible for the safety, reliability and performance issues and any monitoring abnormality, human injury and equipment damage due to users’ 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, which can be used repeatedly.

• 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 special patients, there should be a more prudent inspecting in the placing process. The device can notbe 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 should not stare at the light.
• Testee can not use enamel or other makeup.
• Testee’s fingernail can not be too long.
• Please refer to the correlative literature about the clinical restrictions and caution.
• This device is not intended for treatment.

Federal law restricts this device to sale by or on the order of a physician.

Safety

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 leav ing factory.

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.

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’ SpO₂ 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.
• 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.

Indication for Use

The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO₂) 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.

Overview

The pulse oxygen saturation is the percentage of HbO₂ in the total Hb in the blood, so-called the O₂ concentration in the blood. It is an important bio-parameter for the respiration. For the purpose of measuring the SpO₂ 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.

Classification

Class II b, (MDD93/42/EEC IX Rule 10)

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 24 hours.
• The product will automatically be powered off when no signal is in the product within 5 seconds.
• Low‐battery indicator as battery icon flash manner.

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.

Environment requirements

Storage Environment

1. Temperature: -40℃～+60℃
2. Relative humidity: 5%～95%
3. Atmospheric pressure: 500hPa～1060hPa

Operating Environment

1. Temperature: 10℃～40℃
2. Relative Humidity: 30%～75%
3. Atmospheric pressure: 700hPa～1060hPa

Principle and Caution

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 (HbO₂) 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

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 SpO₂ sensor and photoelectric receiving tube should be arranged in a way with the subject’s arteriole in a position there between．
3. The SpO₂ 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.

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 SpO₂ 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 SpO₂ 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 SpO₂ measure.
4. As the SpO₂ value serves as a reference value for judgement of anemic anoxia and toxic anoxia, some patients with serious anemia may also report good SpO₂ measurement.

Technical specifications

Display Format: Digital tube Display;
SpO₂ Measuring Range: 0% — 100%;
Pulse Rate Measuring Range: 30 bpm — 250 bpm;
Pulse Intensity Display: columniation display
Power Requirements: 2 × 1.5V AAA alkaline battery (or using the rechargeable battery instead), adaptable range: 2.6V~3.6V.
Power Consumption: Smaller than 25 mA.
Resolution: 1% for SpO₂ and 1 bpm for Pulse Rate.
Measurement Accuracy: ± 2% in stage of 70%-100% SpO₂, and meaningless when stage being smaller than 70%. ± 2 bpm or± 2% (select larger) for Pulse Rate.
Measurement Performance in Weak Filling Condition: SpO₂ and pulse rate can be shown correctly when pulse-filling ratio is 0.4%. SpO₂ error is ± 4%, pulse rate error is ± 2 bpm or ± 2% (select larger).
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%.
It is equipped with a function switch. The Oximeter can be powered off in case no finger is the Oximeter within 5 seconds.
Optical Sensor
Red light (wavelength is 660nm, 6.65mW)
Infrared (wavelength is 880nm, 6.75mW)

Accessories

• One hanging rope;
• Two batteries;
• One User Manual.

Installation

View of the front panel

Figure 2. Front View

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.

Figure 3.Batteries Installation

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.

Figure 4. Mounting the hanging rope

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.

Fingernails and the luminescent tube should be on the same side.

Repairing and Maintenance

• Please change the batteries when the low-voltage displayed on the screen.
• Please clean the surface of the device before using. Wipe the device with medical alcohol first, and then let it dry in air or clean it by dry clean fabric.
• Using the medical alcohol to disinfect the product after use, prevent from cross infection for next time use.
• Please take out the batteries if the oximeter is not in use for a long time.
• The best storage environment of the device is — 40º C to 60º C ambient temperature and not higher than 95% relative humidity.

The device needs to be calibrated once a year (or according to the calibrating program of hospital). It also can be performed at the state-appointed agent or just contact us for calibration.

High-pressure sterilization cannot be used on the device.

Do not immerse the device in liquid.

It is recommended that the device should be kept in a dry environment. Humidity may reduce the useful life of the device, or even damage it.

Troubleshooting

Key of Symbols

Symbol	Description
	Type BF
	See User Manual
	The pulse oxygen saturation(%)
	Pulse rate (bpm)
	The battery voltage indication is deficient (change the battery in time avoiding the in exact measure)
	no finger inserted An indicator of signal inadequacy
	battery positive electrode
	battery cathode
	Power switch
SN	Serial number
	Alarm inhibit
	WEEE (2002/96/EC)
IPX1	Ingress of liquids rank

Function Specification

CONTEC MEDICAL SYSTEMS CO., LTD

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 Contec Pulse Oximeter CMS50DL Manual

Пульсоксиметры CMS 50 D+ и CMS 50 DL предназначены для измерения показателя насыщенности артериальной крови кислородом (SpO2) методом светодетектирования. Пульсоксиметры являются многоразовым медицинским устройством.

Применяется пульсоксиметры для клинического мониторинга взрослых, детей в больницах, клиниках, лечебно-профилактических учреждениях или на дому.

Пульсоксиметры можно использовать для измерения уровня насыщенности крови кислородом и частоты пульса с помощью пальца. Изделие подходит для использования на дому, медицинских учреждениях, для наблюдения за физическим состоянием в спорте (пульсоксиметр может быть использован до или после занятий спортом, но его не рекомендуется использовать в процессе тренировки).

Показания пульсоксиметров при наличии в крови карбоксигемоглобина будут существенно завышенными, если пациент страдает от токсикоза угарным газом, так как датчик реагирует на оксигемоглобин и карбоксигемоглобин одинаково, поэтому изделие нельзя использовать при таких обстоятельствах.

Производитель пульсоксиметров CMS 50 D+ и CMS 50 DL – компания КОНТЕК МЕДИКАЛ СИСТЕМС КO., ЛТД. (CONTEC MEDICAL SYSTEMS Co., Ltd.). Страна производитель Китай.

Технические характеристики пульсоксиметров CMS 50 D+ и CMS 50 DL

Основные технические характеристики пульсоксиметров для моделей в исполнениях CMS 50 D+ и CMS 50 DL.

Пульсоксиметры CMS 50 D+ и CMS 50 DL: Внешний вид

Способ применения

• Вставьте две батареи в правильном направлении, а затем верните на место крышку.
• Откройте зажим, как показано на рисунке.
• Положите палец пациента в резиновые подушки зажима (убедитесь, что палец находится в правильном положении), а затем закрепите палец.
• Не трясите палец и следите, чтобы пациент сохранял стабильное состояние в процесс измерения.
• Данные можно считывать непосредственно с экрана интерфейса измерения.

Изменение направление дисплея

На экране интерфейса измерения совершите короткое нажатие на кнопку, чтобы изменить отображение.

Приостановка аварийного оповещения

• Аварийное оповещение включает в себя сигнал об измерении данных измерений, выходящих за пределы, сигнализирует о низком напряжении, сигнализирует о выходе из положения пальца.
• На измерительном интерфейсе, если функция аварийного оповещения включена, в течение периода сигнала вы можете приостановить ее, нажав кнопку коротким движением, но функция будет возобновлена примерно через 30 секунд.
• Если вы хотите отключить оповещение навсегда, вы должны войти в меню.

Настройка передачи данных

Во-первых, пожалуйста, установите аффилированное программное обеспечение на компьютер, после установки на рабочем столе появятся два значка. Значок «SpO2» — это программа для приёма данных в режиме реального времени и Значок «SpO2 Review» — это программа для приёма сохранённых данных.

• Подключите устройство к компьютеру с помощью кабеля для передачи данных, затем дважды щёлкните значок «SpO2», чтобы запустить программу.
• Когда вы отсоединяете кабель для передачи данных от компьютера, на рабочем столе появляется диалоговое окно «Save data at view», в котором вы можете ввести основную информацию о пациенте.

Ограничения к применению

1. Поскольку измерения проводятся на основе артериального пульса, необходим существенный пульсирующий кровоток субъекта. Для пациента со слабым пульсом из-за шока, низкой температуры окружающей среды / тела, значительного кровотечения или использования сосудосуживающего лекарственного средства, форма графика SpO2 (PLETH) будет уменьшаться. В этом случае измерение будет более чувствительным к помехам.
2. Для пациентов, у которых имеется значительное количество лекарственного окрашивающего средства (например, метиленового синего, индиго зелёного и синего голубого) или гемоглобина монооксида углерода (COHb) или метионина (Me + Hb) или тиосалицилового гемоглобина, а у некоторых пациентов при наличие желтухи, определение SpO2 этим пульсоксиметром может быть неточным.
3. Препараты, такие как допамин, прокаин, прилокаин, лидокаин и бутакаин, также могут быть основным фактором, ведущим к серьёзной ошибке измерения SpO2.
4. Поскольку значение SpO2 служит в качестве контрольного значения для оценки аномальной аноксии и токсической аноксии, некоторые пациенты с серьёзной формой анемии могут также показывать хороший результат измерения SpO2.

Техническое обслуживание

Периодически проверяйте пульсоксиметры CMS 50 D+ и CMS 50 DL, комплектующие и принадлежности, чтобы убедиться, что нет видимых повреждений, которые могут повлиять на безопасность и мониторинг пациента через кабели и преобразователи. Рекомендуется, чтобы устройство проверялось как минимум раз в неделю. При очевидном повреждении прекратите использование устройства. Кроме того, общая проверка пульсоксиметра, включая проверку безопасности, такую как ток утечки, должна выполняться только квалифицированным персоналом один раз в 12 месяцев.

• Необходимое техническое обслуживание должно выполняться только квалифицированными сервисными инженерами. Пользователям не разрешается делать это самостоятельно.
• Пульсоксиметры не допускается использовать вместе с устройствами, не указанными в Руководстве (не используйте пульсоксиметр в процессе МРТ и КТ). Только комплектующие и принадлежности, указанные или рекомендуемые производителем, могут использоваться с этим устройством.
• Пульсоксиметры откалиброваны перед тем, как были выпущены с производства, повторная калибровка не требуется.

Пульсоксиметры CMS 50 D+ и CMS 50 DL: Обзор

Насыщенность (сатурация) гемоглобина кислородом – это процентное содержание оксигемоглобина (HbO2), смешанного с кислородом. От общего количества гемоглобина в крови. Другими словами, это плотность оксигемоглобина в крови. Это очень важный экологический параметр для системы дыхания и кровообращения. Многие респираторные заболевания могут привести к снижению сатурации гемоглобина в крови человека. Кроме того, следующие факторы также могут привести к проблемам подачи кислорода, так что насыщение гемоглобина у человека может быть снижено:

• автоматическое органическое регулирование неисправности, вызванной анестезией;
• интенсивная послеоперационная травма;
• боль в результате какой-либо медицинской экспертизы и т.д.

Может появиться недомогание, такое как головокружение, астения, тошнота и так далее, а также поставлена под угрозу жизнь пациента. Поэтому очень важно своевременно узнавать насыщенность гемоглобина пациента в ходе клинических медицинских аспектов, чтобы врачи могли вовремя заметить проблемы.

Пульсоксиметры CMS 50 D+ и CMS 50 DL отличаются небольшим размером, низким энергопотреблением, удобством эксплуатации и лёгкостью в переноске. Пациентам только необходимо поместить один из его пальцев в зонд для диагностики, и экран дисплея сразу покажет измеренное значение уровня насыщения кислородом с высокой точностью и повторением.

Пульсоксиметры CMS 50 D+ и CMS 50 DL: Принцип действия

Принцип работы пульсоксиметра следующий: Формула для обработки данных установлена на основании Закона Ламберта-Бера в соответствии со Спектром поглощения восстановленного гемоглобина (Hb) и оксигемоглобина (HbO2) в зоне, через которую пропускают свет (инфракрасный свет).

Принцип действия прибора следующий: технология фотоэлектрического контроля уровня оксигемоглобина принимается в соответствии с технологией сканирования мощности пульса и записи, таким образом, что два луча с различной длиной волны света могут быть сфокусированы на кончике ногтя человека через сенсорный зажимный датчик на пальце. Затем измеряемый сигнал может быть получен с помощью светочувствительного элемента, полученная информация будет отображаться на экране путем обработки в электронных схемах и микропроцессоре.

Пульсоксиметры CMS 50 D+ и CMS 50 DL: Комплектация

Ниже указана комплектация пульсоксиметров для моделей CMS 50 D+ и CMS 50 DL.

Пульсоксиметры CMS 50 D+ и CMS 50 DL в обоих вариантах исполнения имеют встроенный (несъемный) датчик SрO2.

Питание пульсоксиметров в обоих вариантах исполнения осуществляется от одноразовых батареек типа ААА. Данные батарейки не входят в комплект поставки и покупаются пользователем отдельно.

Во время работы на дисплей пульсоксиметров выводятся рассчитанные значения SpO2, частоту пульса, отображение гистограммы, формы импульса. Пульсоксиметры предназначены для ношения на теле (на пальце, на груди, в руках или в кармане). Пульсоксиметры CMS 50 D+ и CMS 50 DL могут входить в оснащение автомобилей скорой медицинской помощи, спасательных служб, применимы при мониторинге состояния пациента в медицинских учреждениях, для личного использования на дому и при занятиях спортом.

Возможности прибора

Основные эксплуатационные характеристики пульсоксиметров CMS 50 D+ и CMS 50 DL.

Пульсоксиметры обеспечивают сигнализацию тревожных событий при измерениях, индикацию ошибок, сигнализацию при выходе рабочих режимов за установленные пределы. Максимальный уровень звукового сигнала издаваемый пульсоксиметром, не превышает 50 дБА.

Степень защиты пульсоксиметров от воздействия пыли и влаги — IP22.

В состав пульсоксиметров входит запрограммированная микросхема со встроенным программным обеспечением SpO2View.

В состав пульсоксиметра в варианте исполнения CMS 50 D+ входит мини диск с программным обеспечением(ПО) «SpO2 Assistant», номер версии: 2.Х, дата: 02.2018 г. для персонального компьютера (ПК), предназначенное для работы с полученными(записанными) данными. В состав пульсоксиметров в вариантах исполнения CMS 50 DL мини диск с ПО «SpO2 Assistant» для работы на ПК не входит. Подробные требования и характеристики ПО «SpO2 Assistant» приведены в Руководстве по эксплуатации ПО «SpO2 Assistant». Применение пульсоксиметров по назначению возможно и без ПО «SpO2 Assistant».

Пульсоксиметры CMS 50 D+ и CMS 50 DL могут обеспечивать продолжительный режим работы не менее 8 часов в сутки. Режим работы — непрерывный, круглосуточный, при ручном и автоматическом управлении.

Пульсоксиметры при эксплуатации устойчивы к воздействию климатических факторов внешней среды для температур от +0 градусов до +40 градусов, относительной влажности воздуха не более 75 % и атмосферном давление 500гПа~1060гПа.

Пульсоксиметры устойчивы к воздействиям, вызванным падением с высоты 50 мм на твёрдую поверхность или грубым обращениям.

Ошбки и немсправности

Ниже указаны ошибки, неисправности прибора и способы их устранения.

SpO2 и частота пульса не может отображаться нормально. 1) Палец неправильно установлен. 2) SpO2 пациента слишком низок, чтобы его можно было обнаружить.

1. Поместите палец правильно и повторите попытку.
2. Обратитесь в больницу для диагностики, если вы уверены, что
   устройство работает нормально.

SpO2 и частота пульса отображаются нестабильно. 1) Палец не находится внутри достаточно глубоко. 2) Палец дрожит или пациент движется.

1. Поместите палец правильно и повторите попытку.
2. Пусть пациент сохраняет спокойствие.

Устройство не включается. 1) Батарея разряжена или почти разряжена. 2) Батарея установлена неправильно. 3) Неисправность устройства.

1. Замените батареи.
2. Переустановите аккумулятор.
3. Обратитесь в местный сервис.

Дисплей внезапно выключается. 1) Это устройство автоматически отключается в течение 5 секунд, когда оно не может обнаружить какой-либо сигнал. 2) Батарея разряжена или почти разряжена.

1. Нормально.
2. Пожалуйста, замените батареи.

Очистка и дезинфекция

Наружные поверхности пульсоксиметров, комплектующих и принадлежностей устойчивы к дезинфекции 3 % раствора перекиси водорода с добавлением 0,5 % универсального моющего средства.

Скачать инструкцию на пульсоксиметры CMS 50 D+ и CMS 50 DL

Скачать инструкцию по применению и другую документацию на пульсоксиметры CMS 50 D+ и CMS 50 DL можно здесь.

Руководство пользователя ( user manual ) на русском языке пульсоксиметры CMS 50 D+ и CMS 50 DL скачать.

Регистрационное удостоверение пульсоксиметры CMS 50 D+ и CMS 50 DL скачать.

Так же смотрите Массажный стол US MEDICA Samurai.