CONTEC CMS50F Wrist-worn Pulse Oximeter User Manual

CMSSOF User Manual
Pulse Oximeter

Instructions to User

Dear users, thank you very much for purchasing the Pulse Oximeter (hereinafter referred to as device). It is a medical device, which can be used repeatedly. 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 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 a 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 MIII and CT, as the induced current may cause a 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 a doctor’s advice, clinical manifestations, and symptoms.
The maintenance to the device or replacement of the battery (non-detachable lithium battery) can only be performed by qualified service personnel specified by the manufacturer, dangers (such as over-temperature, fire, or explosion) may occur when replacing the battery by the personnel not fully trained. Users are not permitted to maintain or refit the device by themselves or replacement of the battery.
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.
The disposal of scrap devices, their accessories, and packaging should follow the local laws and regulations, to avoid polluting the local environment. And the packaging materials must be placed in the region where the children are out of reaching.
The device can not be used with 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
The disposal of scrap devices. its accessories and packaging should follow local laws and regulations, to avoid polluting the local environment. And the packaging materials must be placed in the region where the children are out of reaching.
The device can not be used with equipment not specified in the Manual. Only the accessories appointed or recommended by the manufacturer can be used, otherwise it any cause injury to the tester and operator or damage to the device
The SpO, probe accompanied is only suitable for use with the device. The device can only use the Sprat probe described in the Manual, so the operator has the responsibility to check the compatibility between the device and the SO: probe before use. incompatible accessories may cause device performance degradation. device damage or user injury.
Do not reprocess the accompanying SpO, probe.
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. ` When the message “Senor or “Sensor Fault- appears on the screen, it indicates that the $eth probe is disconnected or a line fault occurs. Check the connection of the SpO, and probe and whether there is damage to the probe. if necessary, please replace the probe to avoid risks.
The probe fault will not result in a safety hard.
Functional testers can not be used to assess the accuracy of the Sp0; probe and Pulse Oximeter. Ir Sonic functional testers or patient simulators can be used to verify whether the device works normally. for example. INDE.X•21.FE Simulator (software version: 1.00). please refer to the Manual for the detailed operation steps. dr 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 equipment that 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.
When storing the device, keep it away from children. pets and insects to avoid affecting its performance.
Do not place the device in places exposed to direct sunlight, or high temperatures. humidity, dust, cotton wool, or easy-to-splash water, to avoid affecting its performance. 4″ The measured accuracy will be affected by the interference of electrosurgical equipment.
When several products are used on the same people 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 6″ This device is not intended for treatment.
The intended operator of the device may be a user. e Avoid maintaining the device during use 6″ Users should read the product manual carefully before use and operate according to the requirements

0verview

Insert the finger when measuring, and the device will directly display the Sp02 value measured, it has higher accuracy and repeatability.
1.1 Features
A. Easy to use.
B. Small in volume, light in weight, and convenient to carry.
C. Low power consumption.
1.2 Intended purpose
The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through the finger. The product is suitable for being used in families, hospitals, oxygen bars, community healthcare, and physical care in sports (It can be used before or after doing sports, and it is not recommended to use the device during the process of having sports) and etc.
1.3 Environment Requirements
Storage Environment
a) Temperature : -40°C—+60°C
b) Relative humidity : <95%
c) Atmospheric pressure : 500hPa∼1060hPa

Operating Environment

a) Temperature: +10 °C— + 40 °C
b) Relative Humidity : <75 %
c) Atmospheric pressure: 700hPa-1060hPa
1.4 Precautions
1.4.1 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 the device is carried from a cold or hot environment to a warm or humid environment, please do not use it immediately, waiting four hours at least is recommended.
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 turn off the device 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 Sp02 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, and the date of manufacture sees the label.
The expected service life of the attached parts or accessories of the equipment is two year.
if the shelf life is less than the expected service life, the shelf life of the attached parts or accessories of the equipment is two year.
This device has the function of prompting, users can check on this function according to chapter 5.3.1 as a reference.
The maximum temperature at the Sp02 probe-tissue interface should be less than 41 °C 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, press “RESET” button to reset it.
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.
The device can not be used during charging. g If necessary, please visit our official website to get the information about Sp02 probe that can be used with this device.
If the device or component is intended for single use, then the repeated use of these parts will pose risks to 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 skin care 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 the thumb or middle finger deeply enough into the probe when measuring.
The finger should be placed correctly (see Attached figure 4), 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 heaters 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 Sp02 probe 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 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.
Please select the medical power adapter to charge it, when connecting the special adapter with the socket, make sure there is no shelter near the socket and it is easy to plug and unplug, otherwise, the power will not be cut off in time when necessary, causing damage.
1.4.2 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 Sp02 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 (Sul-lb)), but the tester may appear hypoxia, it is recommended to perform further assessment according to the clinical situations and symptoms.
D. Pulse oxygcn only has a reference meaning for anemia and toxic hypoxia, as some severe anemia users still show better pulse oxygen measured valued.
E. Contraindication:
a. The person who is allergic to silicone, PVC, TPU TPE or ABS can not use this device. b. The damaged skin tissue can’t be measured. c. During cardiopulmonary resuscitation. d. When the user is hypovolemic. e. For assessing the adequacy of ventilatory support. f. For detecting worsening lung function in users on a high concentration of oxygen.
1.5 Clinical indications
The Pulse Oximeter can be used in measuring the pulse oxygen saturation and pulse rate through the finger.

Principle

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 (Hb02) in glow & near-infrared zones. The 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 wavelengths of light can be focused onto a human nail tip through a perspective clamp fmger-type sensor. Then measured signal can be obtained by a photosensitive element, information acquired through which will be shown on screen throw,* treatment in electronic circuits and microprocessor.

Functions

A. Sp02 value display
B. PR value and bar graph display
C. Pulse waveform display
D. Low-battery indication: low-battery indication appears when the battery voltage is too low to work
E. Automatic standby function
F. display mode can be changed
G. Adjustable screen brightness
H. PR sound indication
I. Voice prompt for over-limit, sensor off/finger-out and low battery.
J. Memory function
K. The data can be uploaded to the terminal equipment by wired mode.
L. The data can be uploaded to the terminal equipment (Bluetooth wired equipment) by wireless mode.
M. With clock function N. Charging function

Installation

4.1 Appearance
USB interface: connect with USB cable or Sp02 probe Button: power on, pause sound prompt, display clock, enter menu, menu operation. RESET hole: reset button inside of it, to reset the device.
4.2 Interface introduction

4.3 Sp02 probe installation
Open the USB plug of the device, then insert the Sp02 probe interface into the USB port of the device.
4.4 Connection of USB cable
Open the USB plug of the device, insert the micro end of the USB cable into the Sp02 probe interface, and the other end into the computer or power adapter.
4.5 Structure and accessories
A. Structure: main unit, SpO, probe, USB cable, power adapter (optional), and Bluetooth adapter (optional).
B. Accessories: one Sp02 probe, one USB cable, one power adapter (optional), one User Manual, and Bluetooth adapter (optional). Please check the device and accessories according to the list to avoid the device can not work normally. C.Software description Software name: CMS5OF embedded software Software specification: no Release version: 2.0 Naming rule for version: V <Major enhancive software upgrade>..<lmprovement software upgrade> involved algorithm: name: plethysmography; type: mature arithmetic Purpose: be used to measure Sp02, pulse rate, etc. Clinical function: calculate Sp02 and pulse rate values by collecting and processing the testee’s pulse signal.

 0perating

5.1 Measurement
A. Insert the finger into the probe as shown in Figure 4.

(The appearance of the actual probe may be different from the one shown as Figure 4, please refer to the actual probe.) B.Press the button to turn on the device, it displays the measurement interface. C.Wait a few seconds, and the device directly shows measurement results on the screen.
Note: when inserting the finger, the light emitting from the sensor must be directly irradiated to the side of the fingernail. Note: during measuring, do not shake the finger and keep quiet, not move.
5.2Measurement interface
A. In the sound prompt “ON” state, when the sound prompt occurs, short press the button to pause the sound prompt, and it will resume automatically after about 60s. The sound prompt includes an over-limit prompt, low-battery prompt, probe off or finger out prompt. B.If you want to turn off the sound prompt permanently, please set it in the menu. If there is no sound prompt, short pressing the button will directly enter the clock interface, and press again to exit.
5.3 Menu operation
Under the measurement interface, long press the button to enter the main menu interface as shown in Figure 5, sound, record, clock, system and Bluetooth, etc. can be set, methods are as followings:

5.3.1 Sound prompt setting
Under the main menu, short press the button to select “Sound”, then long press the button to enter its setting interface shown in Figure 6. Short press the button to select the option to be adjusted, then long press the button to change the value. “Direction”: direction, “up”: increase the value, “down”: decrease the value “Sp02 HI”: upper limit prompt for Sp02 over-limit “Sp02 LO”: lower limit prompt for Sp02 over-limit “PR HI”: upper limit prompt for PR over-limit “PR LO”: lower limit prompt for PR over-limit “Prompt Sound”: prompt for over-limit, “off’: close, “on”: open. “Pulse Sound”: PR sound, “off”: close, “on”: open. The lower limit can not exceed the upper limit, and the upper limit can not be lower than the lower limit when adjusting the values. Sp02 range: 0 % — 100 %, PR range: 0 — 254 bpm The values displayed in Figure 6 arc the initial values of the ovcr-limit prompt. After setting, short press the button to select “Exit”, then long press the button to exit sound setting interface, and return to Main Menu interface.
5.3.2 Data storage
Under the main menu, short press the button to select “Record”, then long press the button to enter the Record Menu interface as shown in Figure 7. It indicates that the device is storing when the red dot “R.” in the measurement interface flickers.

Short press the button to select the option to be adjusted, then long press the button to change the value. “Mode”: record mode selection, including “Auto” and “Manual” modes. Under “Manual” mode, select to turn on / off memory by “Record”. Auto record: start recording after stable data appear, pull out the finger to finish recording a group of data (99 groups of data at most), the total duration does not exceed 72 hours. Manual record: store up to 24-hour data. When the memory is full, it will display “Memory is full!”, then it will enter standby mode after several seconds. When exiting the standby mode, it will display “Memory is HP” to give the user a prompt, press the button again to enter the measurement interface.
Note: under manual mode, when “Record” is “ON”, the device will prompt to clear the data stored last time. It will display “Recording” when there is no operation under the record state for the 30s, then it will enter energy-saving mode after several seconds, long press the button to exit this mode; short press the button, it will display “Recording”.
Note: under data recording state, after the display screen turns off automatically, in order to save power, pulse sound indication will turn off automatically.
“Seg”: data segment. After setting, short press the button to select “Exit”, long press the button to exit the record menu, and return to the main menu. “Delete All”: delete all records (auto record mode is shown as Figure 7).
Note: Please upload data in time after recording, otherwise the data may be covered when the storage space is full.
Note: the historical data will be deleted once switching the record mode. Under the recording state, the record mode can not be switched; under manual mode, the “Record” should be turned off before switching mode.
5.3.3 Cock setting
Under main menu, short-press the button to select “Clock”, long press the button to enter its sub-menu as shown in Figure 8.

Short press the button to select the option to be adjusted, then long press the button to change the value. The device adopts a 24-hour clock. “set time”: set the time, “yes”: to set the time, “no”: not set the time “set year”: set the year “set month”: set the month “set day”: set the day “set hour”: set the hour “set minute”: set the minute After setting, short press the button to select “Exit”, then long press the button to exit clock setting interface. If the user changes the setting, the current set time will be displayed, then press the button to return to the main menu; if the time is not set, it directly returns to the main menu. 5.3.4 System setting and other options introduction Under main menu, short press the button to select “System”, then long press the button to enter the interface as shown in Figure 9. Short press the button to select the option to be adjusted, then long press the button to change the value. “Hard.Ver.”: hardware version “Soft.Ver.”: Software version “ID”: user name “Demo”: set the Demo mode, “on”: turn on the Demo mode, “off”: turn off the Demo mode. “Sound Volume”: set the sound volume, adjustable range: 1 — 3 “Brightness”: set the screen brightness, adjustable range: 1 4
After setting, short press the button to select “Exit”， then long press the button to exit the system menu and return to the main menu.
5.3.5 Bluetooth setting Under main menu, short-press the button to select “Bluetooth”， then long-press the button to enter its selection interface as shown in Figure 10 and Figure 11. When the Bluetooth is “ON’， if there is no data to be transmitted, the Bluetooth will turn off automatically after a few seconds. Note: Under the data transmitting state by Bluetooth, the Bluetooth can not be turned off.

5.3.6 Shutdown
Under the main menu interface, short press the button to select “Power of 1 ’， then long press the button to turn off the device.
5.3.7 E\il main menu
Under main menu, short press the button to select “Exit”， then long press the button to exit the main menu and return to the measurement interface.
5.4 Data upload
5.4.1 Wired transmission
Connect the device to the computer by the USB cable, and upload the data after connecting with the PC software properly, refer to “Software operating instructions” for details.
Note: The PC software can be downloaded from our official website.
5.4.2 Bluetooth wired transmission
Turn for d ou the device Bluetooth and the PC software to upload data, refer to “Software operating instruction’ details.
5.5 Charging
A power adapter can be selected to charge the device. It indicates that the device is charging when the indicator is orange, and the charging is finished when the indicator turns to green. |
5.6 Reset
Use a pointed and hard object (for example, a paper clip) to press the reset button inside of the RESET hole, to reset the device.
6.1 Cleaning and Disinfecting
The device must be turned off before cleaning, and it should not be immersed in liquid. Please take out the internal battery before cleaning, do not immerse it in 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 a clean and soft cloth. Do not spray any liquid on the device directly, and avoid liquid penetrating into the device.
6.2 IVIainlcnancc
A.Check the main unit and all accessories periodically to make sure that there is no visible damage that may affect user’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.Plcasc charge the battery in lime when a low battery appears.
D. Recharge the battery soon after over-discharge. The device should be recharged every three months when it is not used for some time. It can extend the battery life following this guidance.
E.The device does need not to be calibrated during maintenance.
6.3 Transportation and Storage
A. The packed device can be transported by ordinary conveyance or according to io the transport contract.
During transportation, avoid strong shock, vibration, and splashing with rain or snow, and it can not be material. transported mixed with toxic, harmful,
B. The packed device should be stored in room with no corrosive gases and good ventilation. Temperature: -40°C~60°C; Humidity: <95

Turboshooting

properly positioned.
2. The finger is shaking or the user is moving.
3. The device is not used in the environment required by the manual.
4. The device works abnormally.| 1. Please insert the finger properly and measure again.
2. Lcl the user keep calm
3. Please use the device in normal orminsnmaL
4. Please contact the after-sales.
The device can not be turned on| 1. Low battery or the battery is drained away.
2. The device works abnormally.| 1-Please charge the battery.
2-Please, contact the after-sales.
The display disappears suddenly.| I . The device enters into energy-saving mode.
2. Low battery.
3. The device works abnormally.| 1, Please contact the after-sales.
2. Please charge the battery
3. Please contact die after-sales.
The device can not be used for full-time after charge.| 1 The battery is not charged fully.
2. The device works abnormally.| 1. Please charge the battery.
2. Please contact the after-sales.
The battery can not be fully charged even after 10 hours of charging
lime.| The battery works abnormally.| Please contact the after-sales.
The data can not be stored.| 1. The device is not operated according to lo the manual.
2.’The device works abnormally.| 1 . Please operate the device according to the manual.
2. Please contact the after-sales.

Key of Symbools

hole
| Temperature limitation| | Humidity limitation

| Atmospheric pressure limitation| | This way up
fraga, a tale with we| | keep any from rear
| Low bona)| | Close the sound prompt
| Pause the sound prompt| | Open the sound prompt
Sensor Off| Menu/ Power button| | Close the PR sound
Recyclable| | Open the PR sound
Bluetooth icon (Bluetooth wired device)| Manufacture Dale|
The probe is disconnected.| Finger Out| The finger is not inserted.
R*| Recording| Sensor
Fault| Probe failure
P/N| Material code| LOT| Batch No.
****| 1. The finger clip falls off 4 Do finch mutat II
2. Probe error
3. Signal inadequacy indicator| | Alarm inhibit

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

sPo: Fee note I I|
---|---
Display range| O%-99%
Measured range| 0%-4.0(P/o
Accuracy see note 2]| 70%-100%: 2%; 0%-69A: unspecified.
Resolution| 1%
PR
Display range| 30bpm 250bpra
Measured range| 30bpm-250bpm
Accuracy see note 31| 12 bpm during the pulse rate range of 30 bpm 99 bpm and
*2% during the pulse rate range of 100 bpm – 250 bpm.
Resolution| I by
Accuracy under low perfusion [sec note 41| Low perfusion 0.4%: 40: <re.,
PR: ±2 bpm during the puke rate range of 30 bpm – 99 bpm and 2%a during the pulse rate range of 100 bpm 250 bpm.
Light interference| under normal and ambient light conditions, the Spia? deviation -I%
Pulse Intensity| Continuous bar-graph display, the higher display indicates a stronger pulse.
Upper and lower limit of measured values
SpO :| 0% 100%
PR| 0 bpm – 254 bpm
Optical sensor !see note 51
Red light| Wavelength: about 660 tun, optical output power :< 6.65 mW
Infrared light| Wavelength: about 905 nm. optical output power < 6.75 mW
Memory| Up to 99 groups of data under the auto mode, total duration does not exceed 72 hours. Up to 24-hour data under manual mode.
Safety class| Internally powered equipment, type BF applied part
International Protection| I P22
Working voltage| DC 3.6 V -4.2 V
Working current| < 100 mA
Power supply A rechargeable lithium battery (3.7V) (The red wire on the battery denotes anode, the black wire on the bancry denotes
| cathode.)
---|---
Battery life| Charge and discharge:no less than 500 times
Adapter specification| Output voltage: DC 5V Output current: 1000 mA
Dimensions and Weight
Dimension| 61 mm(L) , :56 mat(W) x 24 mm(H)
Weight| About 60 g (including a lithium battery)

Note 1: the claims of SpC>2 accuracies 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 % Sp0:, compare the SpO: values collected by the secondary standard pulse oximeter equipment and the tested equipment al the win time, to form paired data, which ore used for (he accuracy analysis.(li is applicable for the probes equipped. There are 12 healthy volunteers (male: 6. female: 6; age: 18-50; skin color: black: 2, light: 8, while: 2) data in the clinical report. Note 2: because pulse oximeter equipment measurements are statistically distributed, only about hvo- thirds of pulse oximeter equipment measurements can be expected to fall within ±Amis of the value measured by a CO-OXIMETER.
Note 3: 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 simulator. Note 4: percentage modulation of infrared signal as the indication of pulsating signal strength, patieut simulator has been used to verify ils accuracy under conditions of low perfusion. SpO? and PR values are different due to low signal conditions, compare Ihcm with the known SpO: and PR values of input signal. Note 5: 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 operated by clinician.

Specification| |
---|---|---
State| Prompt condition delay| Prompt signal generation delay
Low voltage prompt| Is| 20ms
SpO: prompt| 330ms| 20ms
Pulse rate prompt| 330ms| 20ms
Probe error prompt| 16ms| _ 20ms

Tabic 1:

Guidance and manufacturer s declaration -electromagnetic emission

The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The purchaser or the user of the device should assure that it is used in such an environment.
Emission test| Compliance
RF emissions C1SPR 11| Group

Table 2:

Guidance and manufacturer’s declaration-electromagnetic immunity|
---|---
The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The purchaser or The user of the Pulse Oximclcr should assure that it is used in such an environment.|
Immunity test| IEC60601 test level| Compliance level
Electrostatic discharge (ESD)
IEC 61000-4-2| ±8kV contact
土 15 kV air| ±8kV contact
土 15kV air
Power frequency (50 / 60Hz)
magnetic field
IEC 61000-4-8| 30 A/m| 30A/m

Table 3:

Guidance and manufacturer’s declaration — electromagnetic immunity

The Pulse Oximeter is intended for use in the electromagnetic environment specified below. The customer the user of the Pulse Oximeter should assure that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level
Radiated RF
I EC61000-4-3
…| 10 V/m 80 MHz’. 2.7 GHz| 10 V/m80 MHz- 2.7 GHz
,
NOTE I Al 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.
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts cannot be predicted theoretically with accuracy. To assess the electromagnetic em environment due to fixed RF transmitters. all electromagnetic site surveys 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. h Over the frequency range 150 KHz to 80 MHz. field strengths should be less than 3V/m.

Table 4：

Guidance and manufacturer’s declaration – electromagnetic Immunity

The [Code SO is intended for use in the electromagnetic environment specified below. The customer or the user of the Pulse Oximeter should assure that it is used in such an environment
| Test Freqte ncy
(MHz)| Band
a)
(MHz)| Service a)| Modulation b)| Mock,’ alien b) (W)| Distance
(m)| IMMUNI TY
TEST
LEVEL
(Wm)
| 385| 3390|  80
TETRA 400| Pulse modulation
18 Hz| K8| 0,3| 27
Radiated| 450| 430
-470| GMRS 460, FRS 460| FMc)
±5 kHz deviation
I kHz sine| 2| 0.3| 28
RF| 710| 704
-787| LTE Band
13,17
780| Pulse modulation b)
Hz| 2| 0.3| 9
IEC610| 745
00-4-3 (Test| 780
sped flea tions for| 810| | GSM
800/900, TETRA
800.
iDEN 820. CDMA 850, LIE Band 5| Pulse modulation b)
18 Hz| C-,1| 0.3| 28
870
ENCLO SURE PORT
I MMUN ITYto
RF
wireless common actions equipment in)| 930| 800
960 –
1720| | GSM 1800; CDMA
1900;
GSM 1900; DECT;
LTE Band I.
3,4,25;
UMTS| Pulse modulation b)
217 Hz| 2
28| It .3|
1845|
1970| 1700
-1990
2450| 2400
-2570| Bluetooth, WLAN,
802.11
big/n,
RFID 2450,
LTE Band 7| Pulse modulation b)
217 Hz| 2| 3| 28
5240| | WLAN
802.11
atn| Pulse modulation b)| 217 Hz 0.2| 0.3| 9
5500| 5100
-5800
5785
NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 at The I m test distance is pcnnidcd by IEC 61000-4-3.
a)For some services, only the uplink frequencies are included.
b)The carrier shall be modulated using a 50 % duty cycle square wave signal.
c)As an alternative to FM modulation. 50% pulse modulation at 18 Hz may be used because it does not represent actual modulation. it would be the worst case.
The MANUFACTURER should consider reducing the minimum RISK MANAGEMENT, and using higher IMMUNITY TEST reduced SWIIIIIInn separation distance. Minimum separation distances LEVELS shall be calculated using the following equation:
Where P is the maximum power in W, d is the minimum IMMUNITY TEST LEVEL in Vim.| separation
separation| LEVELS distance, based on
that are appropriate for the for higher IMMUNITY TEST distance in ra, and E is the

Wiaming
Don’t near active HFSURGICAL EQUIPMENT and the KF shielded room of an ME SYSTEM for magnetic resonance imaging, where the intensity of EM DISTURBANCES is high. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.”
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the device including cables specified by Che manufacturer. Otherwise, degradation of the performance of this equipment could result.
Active medical devices are subject to special EMC precautions and they must be installed and used in accordance with these guidelines.

A Note：
When the device is disturbed, (the data measured may fluctuate， please measure repeatedly or in another environment to ensure its accuracy. Bluetooth Specification Working frequency: 2402 MHz 2480 MHz Modulation mode: GFSK Transmitting power:-6 dBm, +4 dBm Receiving sensitivity: -93 dBm

FCC Caution

§ 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 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 to 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.

The device has been evaluated to meet the general RF exposure requirements. The device can be used in portable/mobile exposure conditions without restriction

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