JUMPER JPD-500D Pulse Oximeter User Guide

: August 6, 2024
: JUMPER

Table of Contents

JUMPER JPD-500D Pulse Oximeter
Product Usage Instructions
FCC Statement
Overview
Operation Guide
Data Communication Function
Maintenance
References
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JUMPER JPD-500D Pulse Oximeter

Product Specifications

Product: Pulse Oximeter
Model: JPD-500D
Date of Issue: 2024.03
Version: V3.0

Product Usage Instructions

Precautions

Do not attempt maintenance unless a professional engineer.
Avoid using the Oximeter on individuals with specific medical conditions (hypotension, severe vascular atrophy, severe anemia, low oxygen levels, sudden cardiac arrest, or shock state).
Avoid using on fingers with nail polish or fake fingernails.
Do not combine old and new batteries or different brands of batteries.
Avoid continuous use for extended periods, especially for patients with microcirculation barriers.
Recommended sensor application time on the same finger is under 2 hours. Avoid use by individuals allergic to silicon rubber.

Symbol Conventions

BF applied part
%SpO2 bpmPR – Symbols for oxygen saturation and pulse rate
No SPO2 alarms. Consult the instructions for use.
Temperature limitation
IP22 degree of protection against water and particulate matter ingress
This product complies with MDR 2017/745 requirements.

Power-On Button/Functional Button Operations
To turn on the Oximeter, press and release the button. Hold the button for about one second to access parameter settings. Press or hold the button for different operations.

Brightness Setting
On interface 1, select the Brightness option by pressing the functional button. Hold the button to set brightness from 1 to 5. Higher values mean brighter screen.

Operation Guide

Place a finger entirely into the Oximeter’s measuring part with the fingernail surface facing up.
Release the clip and press the power button to turn on the Oximeter.

FAQ

Q: Are there any side-effects associated with using this device?
- A: The device has no side-effects if used correctly, and any residual risks are considered acceptable.

Pulse Oximeter
Date of Issue: 2024.03, Version: V3.0

JPD-500D

FCC Statement

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions

This device may not cause harmful interference, and
this device must accept any interference received, including interference that may cause undesired operation.

Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.

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.

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. End user must follow the specific operating instructions for satisfying RF exposure compliance. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

The portable device is designed to meet the requirements for exposure to radio waves established by the Federal Communications Commission (USA). These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue

Precautions

Do not attempt to maintain the Oximeter unless you are professional engineers. Only professionals with maintenance qualification are allowed to perform interior maintenance as necessary.
Periodically change the contact position between the Oximeter probe and the finger for a measurement. Adjust the position of the probe before the measurement, and check the integrity of skin, blood circulation condition of the finger as well as the position of the finger.
This product is not applicable to the examination of newborn babies.
Seek for medical care in time if the measured value goes beyond the normal range while you are sure that the instrument does not malfunction.
Do not directly expose your eyes to light-emitting components of the Oximeter, as that could cause harm to your eyes.
Do not expose the device to lint, dust, light(including sunlight), pets, pests, or children, etc.
This pulse oximeter is not intended to diagnose or treat any medical condition or disease. People who need SpO2 and pulse rate measurements because of a medical condition should not use the oximeter and should consult with their physician.
Do not self diagnose and treat based on measurement results, please always consult a doctor.
For details about clinical limitations and contraindications, please carefully consult relevant medical literatures.
It needs more than half an hour to warm or cool from the minimum /maximum storage temperature between uses until it is ready for intended use.
Please note the effects of degraded sensors that can degrade performance or cause other problems.
The patient is an intended operator.
The lay operator or lay responsible organization should contact the manufacturer or manufacturer’s representative on the following issues:
Assistance in setting up, using, or maintaining the equipment or system when needed.
To report unexpected operation or events.
The following factors may cause disturbance to or affect the accuracy of examination:
This product is used in an environment involving high-frequency devices, such as high-frequency electric knives and CT apparatuses.
The probe of the Oximeter is placed on the same body part or limb as with 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 finger with nail polish or a fake fingernail may cause wrong readings of pulse oxygen saturation.
Please note the effects of degraded sensors that can degrade performance or cause other problems.
Do not combine old and new batteries, different brands batteries for using.
Uncomfortable or painful feeling may appear if using the device ceaselessly, especially for the microcirculation barrier patient. It is recommended that the sensor should not be applied to the same finger for over 2 hours.
The person who is allergic to silicon rubber can not use this device.

Note: The device has no side-effects if administered correctly and residual risk is acceptable.

Warnings

Warning: Do not use the Oximeter in an environment with any inflammable gases, inflammable anesthetic, or other inflammable substances.
Warning: Do not attempt to charge any common dry battery, as that could cause leakage, fire disaster, or even explosion. Dispose of exhausted batteries in accordance with environment protection regulations.
Warning: Do not use the Oximeter in an MRI or CT environment.
Warning: Do not operate the Oximeter when it is damp with overflow or water
vapor condensation. Avoid moving the Oximeter from an excessively-cold environment to a high-temperature moist environment.
Warning: No modification of this equipment is allowed for safety.
Warning: Do not use accessories and detachable parts not specified or authorized by manufacturer. Otherwise, it may cause damage to the unit or danger to the user or patients.
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: Close the battery cover when the instrument is in use.

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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 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.

Intended Use
The Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. The portable fingertip device is indicated for adult and pediatric patients at home and hospital environments. Intended user: Professional or lay person.

Scope of Application
It is applicable to a wide range of fields, such as families, hospitals, 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.

Working Principles
The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole land diastole, as blood volume increases and decreases.

Appearance of Structure

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Screen Display
The following figure shows the information display on the OLED screen of the Oximeter in normal detection state

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Power-On Button/Functional Button Operations
Press and release the button to turn on. Press and hold the button for about one second, the Oximeter shows a parameter setting interface. Press or hold the button to perform corresponding operations. Hold it to set an item, or press it to switch an option. Press means no more than 0.5 seconds, while hold means more than 0.5 seconds.

Setting

Device information : Hold the functional button when the “*” indicates device info to enter interface 2 to look over FCC ID, IMEI and ICCID.
Demo: When “on”, oximeter is for demo use only, display value not real. When “off”, demo mode off.
Note: When the “Demo” option is set to “on”, it means that it is in the demo mode, the Finger Clip Pulse Oximeter is for demo use only, the value on the display interface is not the real measurement result.
Restore: Long press to reset to factory settings, returning all oximeter settings to their original state.
Mode selecting: On interface 1, press the functional button to select the Mode option and then hold the functional button to set the Network(CATM/NB/JB). After switching networks, a reboot is required.
Upload: When set to “on”, measurement results are automatically uploaded. When set to “off”, results are not uploaded and measurement status is maintained. Default setting is “on”.
Brightness setting : On interface 1, press the functional button to select the Brightness option and then hold the functional button to set the brightness to a value ranging from 1 to 5. The greater the value, the greater the brightness of the screen.

Note: The matching network has already been set up by default (CATM）.

IMEI : International Mobile Equipment Identifier.
ICCID : SIM card identification code.
Back : Long press to return to the previous interface.
Exit : Long press to exit the setting interface.

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Operation Guide

Stick one finger completely into the measuring parts of the Oximeter, keep the fingernail surface upward, and release the clip. Then press the power button to power on the Oximeter
If you do not yet completely insert your finger into the chamber, the measurement result may be inaccurate.
Do not vibrate your finger during measurement, ensure that your body does not move.
After the readings become stable, read the measured values of oxygen saturation and the pulse rate on the screen.

NOTE: The Oximeter will automatically shut down 10 seconds later after your finger leaves away.

Data Communication Function

Once the data has been displayed on the screen, the cellular data transfer will begin automatically. Uploading will appear on the screen. as shown in Figure 1 and 2）
The SPO2 reading, and the PR will be uploaded in the patient record associated with the device serial number. Once the data has been transferred the screen will display a message “ SUCCESS (as shown in Figure 3）
The device will automatically be powered off after about 10 seconds.
When the received signal is inadequacy, “ FAILED ” will be display on the screen. （as shown in Figure 4）

During the initial setup, the device will configure the network, which may extend data transmission for up to 10 minutes.
Device data transmission via cellular network is affected by signal strength, carrier network, coverage, congestion, and server status, leading to possible transmission failures or delays.
The device has a data retransmission mechanism. In case of transmission failure, an error code is displayed, and data is automatically saved. The system will upload the saved data during the next measurement.
Before replacing the battery, ensure all unsent data is uploaded to prevent loss during battery replacement.
When the low battery symbol appears, promptly replace the battery to avoid potential data upload issues
Do not replace the pre-installed SIM card. Contact after-sale service with any questions.
If data upload fails, check the troubleshooting section. If the problem persists, contact after-sale service

Replace Battery

Replace the batteries in low power when the icon flickers on screen. Open the battery cover with your fingers, you can replace the batteries according to the correct battery polarity.

If not used for over 3 months, remove the battery.
Dispose of the battery following relevant laws and regulations after use.
Correctly install battery polarity to avoid device damage. $JUMPER-JPD-500D-Pulse-Oximeter-IMAGE $10$$

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 OLED screen) using 75% medical alcohol and a piece of dry soft cloth before changing patients.

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 silicon 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 once a year.
Keep the transmitting and receiving windows free of obstructions before and after use.
No service /maintenance while the equipment is in use.

Troubleshooting

Problem| Possible Cause| Solution
The unit fails to power on.| Low battery| Change the batteries.
Polarities of the batteries are

reversed.

| Make sure the batteries

are installed correctly.

The unit is damaged.| Contact the manufacturer.
The unit doesn’t display any information.| The emitting light doesn’t power on.|

Contact the manufacturer.

Data Communication Troubleshooting
Error code| Possible cause| Solution
FAILED1| Failed to check IMEI| Communication is abnormal. Please contact customer support for after-sale service.
FAILED3| Failed to check SIM info| SIM card is not detected or PIN code needs to be set. Please contact customer support for after-sale service.
---|---|---
FAILED4| Failed to

check ICCID

| SIM malfunction. Please contact customer

support for after-sale service.

FAILED10| Failed to register network| The registration network timeout or the registration network is rejected, you can retry in the following 2 ways.

Please move the device to a place where the cell phone signal is strong.
Restore factory settings.

If the problem persists, please contact your dealer.

FAILED18| Failed to set up server| HTTP server failure or DNS resolution error. Please contact customer support for after-sale service.
FAILED20| Failed to send

data

| HTTP server communication failure. Please contact customer support for after-sale service.
Other Error Codes| /| Please move to a location where there is a strong cell phone signal. If the problem persists, record the error code on the display and contact your dealer.
Product Accessories

Technical statement

The device has no alarm system for SpO2 or pulse rate physiological alarm condition.
When the signal detected by the pulse oximeter is inadequacy or weak, the SpO2 and Pulse rate readings on display are: “–” and “—“.
FUNTIONAL TESTER can not be used to assess the accuracy of a pulse oximeter probe or a pulse oximeter monitor.
The pulse oximeter has a specific calibration curve which is accurate for the combination of the pulse oximeter and pulse oximeter probe. If the functional tester can measure the error comes from the main part of the pulse oximeter, the accuracy of the pulse oximeter that replicates this calibration curve can be verified.
MANUFACTURER will ma ructions, or other information that will assist service personnel designated by the manufacturer in parts repair.
The pulse rate waveform is normalized. When the pulse rate waveform tends to be smooth and stable, the measurement value is optimal. Data update period: less than 30s, data averaging: every 8 data.

Note 1 ：The Pulse oximeter 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 2 ：The statistic conclusion of an controlled desaturation study which guided by “ISO 80601-2-61, Annex EE, guideline for evaluating and documenting SpO2 accuracy in human subjects”. The statistic result displayed the accuracy distribution between the range of 70%-100%

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
Packaged products should be stored in well-ventilated rooms without corrosive gas and with an ambient temperature of –10C to +50C, a relative humidity 10%- 93% (without condensation), and an atmospheric pressure of 50–106 kPa.

After-sale Service
After-sale service unit: Shenzhen Jumper Medical Equipment Co., Ltd. Address: D Building, No. 71, Xintian Road, Fuyong Street, Baoan, Shenzhen,Guangdong,China, 518103 Tel: +86-755-26696279

EMC Information-Guidance and Manufacture’s Declaration

WARNING: 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.”
WARNING: 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.”
WARNING: 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 ME equipment, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.”

Table 1

declaration – electromagnetic emission

Table 2

declaration – electromagnetic immunity

Immunity test| IEC 60601 test level| Compliance level
Electrostatic discharge (ESD)

IEC 61000-4-2

| ±8 kV contact

±2 kV, ±4 kV, ±8 kV, ±15 kV

air

| ±8 kV contact

±2 kV, ±4 kV,

±8 kV, ±15 kV

air

Electrical fast transient/burst IEC 61000-4-4| ± 2 kV for power supply lines

± 1 kV for input/output lines

| Not applicable
Surge

IEC 61000-4-5

| ± 0.5kV, ± 1 kV line(s) to lines

± 0.5kV, ± 1 kV, ± 2 kV line(s) to earth

| Not applicable
Voltage dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| 0 % UT; 0.5 cycle At 0°, 45°,

90°, 135°, 180°, 225°, 270°and 315°

0 % UT; 1 cycle and 70 % UT; 25/30 cycles Single phase: at 0°

0 % UT; 250/300 cycles

| Not applicable
Power frequency

(50/60 Hz) magnetic field IEC 61000-4-8

| 30 A/m| 30 A/m

NOTE: UT is the a.c. mains voltage prior to application of the test level.

declaration – electromagnetic immunity

Immunity test| IEC 60601 test level| Compliance level
Conducted RF IEC 61000-4-6| 3 V

0.15 MHz to 80 MHz

6 V in ISM bands between 0.15 MHz and 80 MHz

| Not applicable
Radiated RF IEC 61000-4-3| 10V/m

80 MHz to 2.7 GHz

| 10V/m
declaration – IMMUNITY to proximity fields from RF wireless communications equipment

Immunity test| IEC60601 test level| Compliance level
Test frequency| Modulation| Maxim um power| Immunity level
Radiated| 385 MHz| Pulse| 1.8W| 27| 27 V/m
RF| | Modulation| | V/m|
IEC| | : 18Hz| | |
61000-4-3| 450 MHz| FM+ 5Hz| 2 W| 28| 28 V/m
| | deviation:| | V/m|
| | 1kHz sine| | |
| 710 MHz| Pulse| 0.2 W| 9 V/m| 9 V/m
| 745 MHz| Modulation| | |
| 780 MHz| : 217Hz| | |
| 810 MHz| Pulse| 2 W| 28| 28 V/m
| 870 MHz| Modulation| | V/m|
| 930 MHz| : 18Hz| | |
| 1720 MHz| Pulse| 2 W| 28| 28 V/m
| 1845 MHz| Modulation| | V/m|
| 1970 MHz| : 217Hz| | |
| 2450 MHz| Pulse| 2 W| 28| 28 V/m
| | Modulation| | V/m|
| | : 217Hz| | |
| 5240 MHz| Pulse| 0.2 W| 9 V/m| 9 V/m
| 5500 MHz| Modulation| | |
| 5785 MHz| : 217Hz| | |
Note – As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. Note** – The carrier shall be modulated using a 50 % duty cycle square wave signal.