submitted | available | document details (if available) | source link |
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August 14 2018 | August 14 2018 |
various | User Manual | Users Manual | 1.60 MiB | August 14 2018 |
JPD-500G(Bluetooth) Pulse Oximeter FCC statement 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.
(2) This device must accept any interference received,including interference that may cause undesired operation. 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 ser 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. Warning: Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. Precautions Do not attempt to repair he Oximeter unless you are professional engineers. Only professionals with maintenance qualification are allowed to perform interior maintenance as necessary. Change the contact position between the Oximeter probe and the finger periodically if you are monitoring your SpO2 levels and pulse rate for more than 2 hours. Stop immediately if you have broken skin or the blood circulation of your finger is affected during prolong use. This product is not designed to be used by newborn babies. Seek for medical care if the measured value goes beyond the normal range and you are sure that the instrument is not malfunctioning. The pulse oximeter uses infrared light (invisible to your eyes) to measure your SpO2 levels. Hence, please do not stare at the light-emitting components of the Oximeter, as that could cause harm and/or potentially blind your eyes. This pulse oximeter is not a medical device and is not intended to diagnose or treat any medical condition or disease. It is intended for non-medical use in healthy people to monitor their pulse and blood oxygen levels during sports and/or aviation only. People who need SpO2 and pulse rate measurements because of a medical condition should not use the oximeter and should consult with their physician. For details about clinical limitations and contraindications,please carefully consult relevant medical literatures. The following factors may affect the accuracy of the measurement:
The Oximeter is used in an environment involving high-frequency devices, such as high-frequency electric knives and CT apparatuses. Ambient light intensity is too bright. Hence, please avoid direct exposure to strong light (such as beams from operating lamps or sunlight) during measurement. The probe of the Oximeter is placed on the same arm that a blood pressure cuff arterial duct or intravenous injection. The user suffers from hypotension, severe vascular atrophy, severe anemia, or low oxygen. The user is in sudden cardiac arrest or shock state. The user is wearing nail polish or artificial nails. Warnings Warning: Do not use the Oximeter in an environment with any flammable gases, flammable anesthetic, or other flammable substances. Warning: Keep unit and lanyard away from children as the included lanyard may present an entanglement or choking hazard to small children. Adult supervision required; never leave children unattended with unit or lanyard Warning: Do not throw the batteries into fire, as that could cause an explosion. Warning: Do not attempt to charge the included batteries, as that could cause leakage, fire disaster, or even explosion. Dispose the used batteries in accordance to the local laws and regulations. Warning: Do not use the Oximeter in an MRI or CT environment. Warning: Caution: Do not operate the Oximeter if it is wet. Avoid moving the oximeter from a cold to a hot and humid environment. Warning: Install the batteries properly before powering on the Oximeter for normal use. Please remove the batteries if you are not planning to use the Oximeter for a long time. Warning: Close the battery cover when the instrument is in use. Symbols Symbol Meaning
%SpO2 bpmPR Type BF applied part Caution: Please see this manual. Symbol of oxygen saturation Symbol of pulse rate No SpO2 alarms. Bluetooth blood in a normal human body is 98%. Oxygen saturation is an important indicator of the oxygen condition in the human body. In general, the normal values of oxygen saturation shall not be lower than 94%. If the measured value of oxygen saturation is lower than 94%, an insufficient supply of oxygen is considered. The pulse rate is the number of pulse beats per minute. Normally, the pulse rate is consistent with the heart rate. In general, the pulse rate of every people is 60 to 90 beats per minute. The Perfusion Index (PI) usually reflects the limb perfusion status of an examined patient, and shows the detection precision of the instrument as well; that is, examination can still be performed even in the low or weak perfusion condition.The PI of a normal human body is 3% or greater. Working Principles and Usage Based on full digital technology, the Finger Pulse Oximeter non-invasively measures the actual content (oxygen saturation) of oxyhemoglobin (HbO2) in arterial blood using the optical transmittance method. The Finger Pulse Oximeter measures the blood oxygen saturation and pulse rate of a human body via finger artery. It is applicable to a wide range of fields, such as families,clinics , oxygen bars, social medical care institutions, and sports & health. Use this instrument for measurement before or after sports. You are not advised to use this instrument during sports activities. Do not use it for continuous care for patients. Schematic Diagram of Display Schematic Diagram of Display The following figure shows the information display on the LED screen of the Oximeter in normal detection state:
When end users abandon this product, they must send the product to the collection place for recycling. Overview Oxygen saturation is the percentage of oxyhemoglobin (HbO2) that is combined with oxygen against all combinable hemoglobin (Hb). It is an important physiological parameter involved in respiration and circulation. The oxygen saturation of arterial Power-On button/Function Button Operations Press the power-on/function button to turn on the oximeter.Once the it is turned on.Simply press or hold the button to perform corresponding operations. Press: Press the button for less than 0.5 seconds. Hold: Press the button for more than 0.5 seconds. Brightness Setting Hold the power-on button while the oximeter is in powered-on state,then the oximeter shows a brightness setting interface(as "Interface 1" below shows, "br"
represents brightness).Hold the button to adjust brightness. There 3 brightness settings(1,2,3). 3 is the brightest. finger. Connecting the Instrument to a smartphone via Bluetooth Note: For details on specific operations, see the JUMPER Health User Manual. Interface1 Replace the batteries when the batteries run out of power and the symbol Alarm Setting After setting the brightness,press the power-on button to enter the alarm setting interface(as "interface 2" below shows, "AL" represents alarm).Then hold the button to set "AL" to on or off.When "AL" is set to on and the measured values of the blood oxygen saturation and pulse rate go beyond the upper limit or lower limit,the oximeter will beep to alarm. Interface 2 Alert Range Setting When "AL" is set to on, you can set the upper limit and lower limit of SpO2 Alert and PR Alert. Press it to switch an option(SpO2 upper limit, SpO2 lower limit, PR upper limit and PR lower limit).Hold the power-on button to adjust the limits.(as
"Interface 3,4,5,6" below show, "Hi" represents upper limit, "Lo" represents lower limit) . Interface 3 Interface 4 Interface 5 Operation Guide Stick one finger completely into the finger chamber of the oximeter. The fingernail should be facing upward. Release the clip and press the power-on button to power on the pulse oximeter. Interface 6 If you do not insert your finger completely into the chamber, measurement will be inaccurate. To keep your finger still during measurement. It is also not advisable to use this instrument during sports activities as movement may lead to inaccuracies. Once the reading stabilizes, read the measured values of oxygen saturation and pulse rate on the screen. NOTE:The oximeter will automatically shut down 10 seconds after you remove your flickers on the screen. Install the two AAA dry batteries into the battery slot according to polarity indication, and mount the battery cover. Cleaning Power off the instrument and remove the batteries before cleaning. Ensure that the appearance of the instrument is neat, dust-free, and dirt-free. Clean the outer surface of the instrument (including the LED screen) using a piece of dry soft cloth dipped with 75% medical alcohol Caution: Avoid liquid flowing into the instrument during cleaning. Caution: Do not immerse any part of the instrument into any liquid. Disinfection Before measurement with the instrument, wipe the rubber finger pad using a piece of dry soft cloth dipped with 75% medical alcohol. Clean the finger to be measured using the medical alcohol for disinfection purposes before and after use. Do not disinfect the instrument by means of high-temperature/high-
pressure or gas disinfection. Maintenance Remove the batteries from the battery slot and properly store them if you do not plan to use the Oximeter for a long period of time. Avoid using the Oximeter in an environment with inflammable gases or using it in an environment where the temperature or humidity is excessively high or low. Check the accuracy of the oxygen saturation and pulse rate readings by using an appropriate calibration apparatus. Technical Specifications 1. Dimensions: 58.0 mm (Width) 32.0 mm (Depth) 32.9 mm (Height) 2. Weight: 50.4 g (including two AAA dry batteries) Peak wavelength range of the light emitted from the probe: red light 663 nm 3; infrared light 900 nm 7. 3. Maximum optical output power of the probe: 60 mW for infrared light (905 6. Default values and conditions of alert Parameter Oxygen saturation Pulse rate Alert condition Value Upper limit: 99 Lower limit: 94 Upper limit: 130 Lower limit: 50 When the alert switch is on and the actual measured value goes beyond the preset alert parameter range, the Oximeter gives an alert sound. 7. Technical parameters Parameter Display range Resolution Measurement precision Alert range Alert error PI Oxygen saturation Pulse rate Oxygen saturation Pulse rate Oxygen saturation Pulse rate Oxygen saturation Pulse rate Oxygen saturation Pulse rate Weak PI Value 35% to 99%
35 bpm to 250 bpm 1%
1 bpm 2% (70% to 99%) No requirement ( 69%) 2 bpm Upper limit: 50% to 100%
Lower limit: 50% to 100%
Upper limit: 35 bpm to 250 bpm Lower limit: 35 bpm to 250 bpm 1% of the preset value The greater of 10% of the preset value and 5 bpm Min. 0.3%
Safety Type Anti-electric-shock type: internal power supply device Anti-electric-shock degree: Type BF applied part Running mode: continuous working Waterproof grade: IP22 Storage and Transportation Temperature : 10C - 50C(14-122) Relative humidity : 10%-93% (no condensation) Atmospheric pressure : 50kPa106 kPa. ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES Guidance and manufacturers declaration - electromagnetic emissions The device is intended for use in the electromagnetic environment specified below. The customer or the user assure that it is used in such an environment. Emissions test Compliance Group 1 Electromagnetic environment - guidance The devuce device use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The device is suitable for use in all establishments other than domestic and nm). Bluetooth module:4.2 4. 5. Normal working condition Working Temperature Relative Humidity Atmospheric Pressure Rated Voltage 5C to 40C (41F to 104F) 15% to 80%, non-condensing 70 kPa to 106 kPa DC 3.0 V RF emissions CISPR11 RF emissions CISPR11 Class B Harmonic emissions lEC61000-3-2 Voltage fluctuations/
Ficker emissionslEC61000-
3-3 Not applicable Not applicable those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes in UT) for 5 sec 3A/m 3A/m Power frequency
(50Hz/60Hz) magnetic field IEC 61000-4-8 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Guidance and manufacturers declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should assure that it is used in such an environment. Immunity test IEC 60601 Test level 6kV contact 8kV air Compliance level 6kV contact 8kV air not applicable Electromagnetic environment-guidance Floors should be wood , concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
not applicable
(For INTERNALLY POWERED ME EQUIPMENT) not applicable not applicable
(For INTERNALLY POWERED ME EQUIPMENT) not applicable not applicable
(For INTERNALLY POWERED ME EQUIPMENT Electrostatic discharge (ESD) lEC61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 2 kV for power supply lines 1 kV Input/
output line 1 kV Differential mode voltage 2 kV Common mode voltage
<5% UT
(>95% dip in UT) for 0.5 cycle 40% UT
(60% dip in UT) for 5 cycles 70% UT
(30% dip in UT) for 25 cycles
<5% UT
(>95% dip NOTE UT is the a.c. mains voltage prior to application of the test level. Guidance and manufactures declaration electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of device should assure that it is used in such an environment. Immunity test Radiated RF IEC 61000-4-3 IEC 60601 test level 3 V/m 80 MHz to 2.5 GHz Compliance level Electromagnetic environment -
guidance 3 V/m P P P 80 MHz to 800 MHz 2.1 2.1 2.1 Portable and mobile RF communications equipment should be used no closer to any part of the Blood Pressure Monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d d d 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 metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a 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:
800 MHz to 2.5 GHz At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic NOTE 1 NOTE 2 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 Blood Pressure Monitor is used exceeds the applicable RF compliance level above, the Blood Pressure Monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Blood Pressure Monitor. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [Vi] V/m. Recommended separation distances between portable and mobile RF communications equipment and the device. The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment. Separation distance according to frequency of transmitter
(m) Maximum output power of transmitter
(W) 80 MHz to 800 800 MHz to 2.5 800 MHz to 2.5 MHz d 2.1 P GHz d 2.1 P GHz d 2.1 P
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0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 0.01 0.1 1 10 100 For transmitters rated at a maximum output power not listed above, There commended 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) accordable to the transmitter manufacturer. NOTEI At 80 MHz and 800 MHz. the separation distance for the higher frequency range applies. NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and refection from structures, objects and people. Wellkang Ltd Suite B, 29Harley Street, LONDON, W1G9QR,U.K. Shenzhen Jumper Medical Equipment Co., Ltd Address: D Building, No. 71, Xintian Road, Fuyong Street, Baoan,Shenzhen, Guangdong,China E-mail: info@jumper-medical.com Tel: +86-755-26692192,26696279 Web:www.jumper-medical.com
This product uses the FCC Data API but is not endorsed or certified by the FCC