Fancydeals SMH-01 Pulse Oximeter User Manual

Fancydeals SMH-01 Pulse Oximeter

Front view

BATTERY INSTALLATION

Part I General Information

Product Information
Product name Pulse Oximeter

Eplanaation of Symbols
The following symbols appear on the Pulse Oximeter and its packaging.

Safety Standards

The following table describes the safety standards of the Pulse Oximeter.

• Degree of protection: Type BF defibrillator-proof: per IEC 60601-1 Degree of noxious-liquid proof as, IPXI Anti-shock degree as BF applied part According to the degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide, the equipment is not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxlde
• Sterilization and disinfectionAs recommended by manufacturer
• Mode of operation: Continuous

Safety Conventions

The manual uses the following conventions for Notes , Cautions, and Warnings.

Note-A Note calls attention to an important point in the text.
Caution A Caution calls attention to a condition or possible situation that could damage or destroy the product or the users work.
Warning A Warning calls attention to a condition or possible situation that could cause injury to the user and/ or users.

Safety Requirements

Warning

• This device is intended for sport and recreational use.
• The Pulse Oximeter is not for diagnostic or therapeutic use.
• Never use the Pulse Oximeter during MRIs or CT scans.
• Never use the Pulse Oximeter in an environment of anestheticgs.
• FUNCTIONAL TESTER cannot be used to asss ACCURACY
• The skin temperature is initally at 35 C for each PULSE OXIMETER, the APPLIEDPART temperature can not exceed41’c.
• The material that the pulse oximeter contacted to body is Non-toxic silica gel which meet the ISO10993 requirements, so can be safety used. But to some natural rubber latex sensitive user , there may be some allergic reactions.
• Only use accessories recommended by the manufacturer. Using other kinds of accessories might cause damage or personal injury. Modification of the Pulse Oximeter could be unsafe as applicable.
• The degrade sensor may degrade the performance.

Caution

• To avoid personal injury, only use accessories and parts produced or recommended by distributor. Otherwise, damage to the Pulse Oximetoue can occur .
• The Pulse Oximeter must conform to the intemational standard IEC6001-1-2 and other applicable EMC standards. Interference takes place when lectromagnetic energy is extremely high. Ensure that any nearby instruments are also in compliance with EMC standards.Never tum on or use portable communication devices like mobile phones or portable dual-channel radios near a Pulse Oximeter.
• When power is lost for less than or equal tc 30, the ALARM SETTINGS prior to the power loss shall be restored automatically
• Ensure that qualified service representatives annually calibrate and maintain the Pulse Oximeter.
• Periodically check the Pulse Oximeter for damage. When necessary according to your local hospital waste disposal regulations.
• Clean and sterilize the Pulse Oximeter and accessoriės according to local requirements. Turn off the Pulse Oximeter before cleaning or sterilization.
• Keep all Pulse Oximeter packing materials away from children , pet c pests, or dispose of them in accordance with your local environmental regulations.
• Inhalation or swallowing of small parts that be detached from Pulse Oximeter may cause choking.
• Always properly dispose of the Pulse Oximeter and all acessories at the end of their service life.Dispose of batteries according to your local regulations .Never incinerate battens or expose them to high temperatures.
• Ensure that no water condenses into or on the Pulse Oximeter Condensation can occur from anges in temperature or exposure to humidity.

Product Operation Scope

This Pulse Oximeter is a kind of innovated detection device with non-invasive and continuous features for artery Spo2 and PR detection. It is portable and easy to measure the Sp02and PR value quickly and precisely. This can be through the finger Pulse Oximeter to meas oxygen saturation and heart rate. This product is suitable for family, clinic, oxygen bar , sports health ( use before and after exercise is not recommended for PaC for use during exercise ), community health and other ranges. It’s for ages from 15 to 60 years old users. This product is not suitable for Pulse Oximetering the users’s prolonged use.

Gencral Description

Haemoglobin Saturation is percentage of Oxyhemoglobin (Hbo2) capacity compounded with oxygen , by all combinativable haemoglobin (Hb ) obin ( Hbo2) capacity in blood In other words, it is consistence of Oxyhemoglobin in blood It is a very important ecological parameter for Respiratory circulation System Many respiratory diseases can result in haemoglobin saturation being lowered in human blood. Moreover, the following factors can also lead to problems in oxygen supply , so that human haemoglobin saturation might be reduced: Automatic Organic Regulation Malfunction caused by Anesthesia, Intensive Postoperative Trauma, hurts resulted in by some medical examination and etc. In the situation , illesses , such as light head , asthenia, vomitory and etc, might happen to users and even endanger the users’s life. Therefore, it is very important to know Hemoglobin saturation of users timely m clinical medical aspects. So that doctors can find problems in time. The fingertip pulse Oximeter features in small volume, low power consumption convenient operation and being portable, It is only necessary for users to put one of his fingers into a tingertip photoelectric sensor for diagnosis .and a display screen will directly show measured value of hemoglobin Saturation It has been proved in clinical experiments that it features in rather high precise and repeatability.

Measurement 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 ( R HB) and Oxyhemoglobin ( 02 Hb) in glow and near-infrared zones. Operation principle of the instrument is photoelectric Oxyhemoglobin Inspection Technology Is adopted in accordance With capaclty pulse scarnning and recording Technology, so that two beams of different wavelength of lights ( 660nm glow and 940nm near infrared light) 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 two groups of LED through process in electronic circuits and microprocessor

Fatures

1. figure and Oxygen volume chart display together on interface;
2. Adjust the display interface Direction manually, according to the users observation data needs
3. audible alarm function Low Power consumption. 20 hours continuous to work
4. Low Perfusion s0.6%.
5. Low voltage indicator.
6. Automatic power off when no signal in 8s.
7. Small and light weight, convenient to carry .
8. A menu function can set up oxygen alarm limit , the upper and lower

Nimits of PR, alarm switch, sound switch.

Part 2 Operation Instructions

Operation Instructions

The produet Operation Istructions

1. Installing two AAA batteries into battery cassette in correct polarities and cover it.
2. Plug onc of fingers into rubber hole of the Oximeter (it is best to plug the finger thoroughly) nail surface upward, then releasing the clamp
3. Press the switch button once on front panel.
4. Your finger do not tremble during the Oximeter is working Your bod is not recommended in moving status.
5.  Read correspondent date from display screen.
   Note- Please use the medical alcohol to clean the rubber touching the finger inside of Oximeter , and clean the test finger using medical alcohol before and after each test ( The rubber inside of the Oximeter belongs medical rubber which has no toxin and no harmful to the skin of human being). When your finger is plugged into the Oximeter, you nail surface must be upward. Disposable batteries should be unloaded when used for a long interva. Warning The maximum apliation time for a PULSE OXIMETER PROBE at a single site is 4 hours. The misapplication ofa PULSE OXIMETER PROBE with excessive pressure for prolonged periods can induce pressure injury. Ambient light ( including photodynamic therapy), physical movement (USERS and imposed motion) , diagnostic testing, low perfusion; electromagnetic interference, HF SURGICAL EQUIPMENT; dysfunctional Haemoglobin, there will be windage for SpO2 value.

Warning

The maximum apliation time for a PULSE OXIMETER PROBE at a single site is 4 hours. The misapplication ofa PULSE OXIMETER PROBE with excessive pressure for prolonged periods can induce pressure injury. Ambient light ( including photodynamic therapy), physical movement USERS and imposed motion ), díagnostic testing, low pertusion; electromagnetic interference, HF SURGICAL EQUIPMENT; dysfunctional haemoglobin, there will be windage for SpO2 value.

Display Description

Button operating Instructions

1. Put into two AAA batteries according to the instructions , the device will turm on automatically and display interface l; then put into finger for measuring, if there is finger for detection and without operation , it power off automatically in 8s.
2. When there is battery, but the Pulse Oximeter power off , press the button, it will be opened.
3. During the measurement ( there is a measurement signal and figure ), press the button shortly, the interface can turns from interface I to interface 6 circularly . Press the button longly during the measurement, it can turn to settings menu interface.
4. In the Settings menu interface, press button longly, it can choose 8 options circularly, they are Alarm switch (Alarm Sound on/ of) , the add and subtract of oxygen lower limit value ( SPO2 Lo +/-) the add and subtract of PR limit value ( PR Hi +/-PRLO +/-), PR Sound switch ( BeeP) and the withdraw from the menu (Exit ). The selected options foreground color will become Blue Square.
5. In the Settings menu interface, press button shortly, we can operate the value add and subtract or switch of current options. they are: The SpO2 default alarm lower limit value is 90, the adjustable range is from 70 to 95 and pressing the button shortly can do add and subtract of Istep. The PR default alarm upper limit value is I 10, the adjustable range is from 110 to 250 and pressing the button shortly can do add and subtract of Steps . The PR default alarm lower limit value is 50, the adjustable range is from 15 to 95 and pressing the button shortly can do add and subtract of 5 steps limit value 90, PR upper limit value 110, PR lower limit value : 50, PR sound off when we replaced the battery.
6. In the Settings menu interface, choose to Exit option and press button shortly, it will quit the setting menu interface.

Alarm

Yie The Pulse Oxieter uses the following alarm indicators audible alarm and visual alarms.
Note: To correctly identify visual alarms, always observe the Pulse Oximeter within I meter of its position.

Low power alarm

when battery power is at lowest level, the battery capacity indicates empty in Display, remind users of replacement of battery.

Note: When power is lost for less than or equal to 30s, the ALARM SETTINGS prior to the power loss shall be restored automatically.

Audible alarm
The audible alarm is buzzer alarm; the auditory sound pressure range is 45dB- 70dB.

SpO2 and PR alarm

• Default alarming Value of PR: High Limit: 110BPM; Lower Limit: 50BPM.
• Default alarming Value of Sp02: 90%.
• When it is under operation conditions , if the measurement of the PR and SpO2 value exceed the setting alarm limit and the alarm switch is on, It has a sound alarm and its long buzzer alarm.
• When it is under operation conditions, if the PR sound switch is on. the measurement PR will go with a PR sound.

To test the alarm according the following:

•  Connect the Pulse Oximeter to simulator;
• the simulator setting: Sp02 90 %o, PR 200bpm;
• the Pulse Oximeter alarm setting : SpO2 9596, PR High Limit I 10 bpm;
• to verify the Pulse Oximeter alarm.

Specifications

The update rate for the SpO2 value and pulse rate is typically l second Data averaging and other signal processing on the displayed and transmitted data values of SpO2 and pulse rate is not more than 20 seconds. Depending on the magnitude of difference between the alarm limit and the displayed value, the alarm signal generation delay may be from I second to 20 seconds. The maximum alarm conditie delay is 4 seconds, the Alum alarm signal delay is 20 seconds, the average alarm condition is 2 seconds, the average alarm signal is 10 seconds. Because pulse oximeter measurements are statistically distributed, only approximately two-thirds of pulse oximeter equipment measurements can be expected to fall within the Arms value measured by a cO-oximeter. The signal adequacy is indicated by waveform, and it is NORMALIZED.

Note: The PULSE OXIMETER EQUIPMENT is calibrated to display FUNCTIONAL OXYGEN SATURATION It is not necessary to have a calibration when the Pulse Oximeter is in use The following table describes the SpO2 specifications

1. Sensor accuracy was obtained by performing controlled hypoxia studies on heathy, non-smoking adult volunteers (according to ISO 80601-2-61). The SpO2 readings have been compared to CO-oximeter measurements on arterial blood samples. To repre-sent the general population, data from at least 10 subjects ( male and female to validate SpO2accuracy Accuracy data for Masimo sensors is included in the sensor package insert.
2. Information about wavelength ranges can be useful for clinicians performing photo dynamic therapy.

Power Specifications

The following table describes the power specifications with a wide range of skin color as taken

Physical Specifications

The following table describes the phvsical specifications

Environmental Specifications

The following table deserihes the environmental specifications

Part 3 EMC Related Summary

1. Pulse Oximeter meets the requirement of electromagnetic compatibility in IEC60601-1-2.
2. Ihe user needs to install and use according to electromagnetism compatibility information which is attached with it.
3. Portable and mobile RF communication devices may influence pulse Oximeter performance, so pulse Oximeter should be kept away from them during using.
4. Guidance and manufacturer s declaration stated in the appendix.

WARNING

1. The user needs to install and use pulse Oximeter according to electromagnetism compatibility information which is attached with it .
2. Portable and mobile frequency communication devices may intluence its performance, so it should be kept off these devices.
3. Pulse Oximeter should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the Pulse Oximeter should be observed to verity normal operation in the configuration in which it will be used.
4. Speaking pulse Oximeter could not be used for transport using, like nbulances ( land and air ambulances ).

Part 4 Repair and Warranty

Repair and Maintenance

1. Regular inspection to make sure that no obvious damage existed to ffect the satety and pertormance of device.
2. No flammable substance , overtop or lower temperature and humidity existed In operation conditions.
3. When the device is dabbled or there is hydraulic set existed, stop operating
4. When lower power capacity light in red pls replace the battery right away.
5.  Pls clean the surface betore applying for detection.
6. Pls take out the battery when device Is not used for a period of time.
7. Pls disposure the battery according to the local statute.
8. If there is dust or dirt on surface, 75 % density of medical alcohol can be used to clean the surface. Pls use dry fabric with little alcohol to can be alcohol permeates into the device.
9. The transportation and storage conditions are Temperature: -20″C-55 C: Humidity: 10 % -93%

Troubleshooting

Package Included

• Fingertip Pulse Oximeter .. pc
• User Manual.. pc

Warranty

The unit can not be repaired by users themselves. All services must be done by the engineers approved by distributor. The unit is guaranteed for a period of 12 months, valid from the date of purchase, Distributor warrants that each product we sell you is free from defects in labor and materials and shall conform to its product specifications as defined in the user documentation If the product doesn’t function as warranted during the warranty period , we will repair or replace it without charge Misuse, improper maintenance may void the warranty.

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