Wearpulse POD1 W Baby Oxygen Meter Finger Pulse Oximeter User Manual

: May 15, 2024
: Wearpulse

Wearpulse POD1 W Baby Oxygen Meter Finger Pulse Oximeter

Wearpulse-POD1-W-Baby-Oxygen-Meter-Finger-Pulse-Oximeter-
product

Product Information

The Fingertip Oximeter is designed for sports and aviation use only, not for medical purposes. It provides accurate measurements of oxygen saturation levels in the blood. The device complies with international safety standards and regulations.

Specifications

Product Name: Fingertip Oximeter
Version of the Manual: Ver 1.0
Revised Date: November 2, 2022
Intended Use: Sports and Aviation (Not for medical use)
Compliance: IEC 60601-1: 2005, ISO 80601-2-61: 2017, MDD 93/42/EEC
FCC Compliance: Part 15

Usage Instructions

Safe Operation
Before each use, check the device for any visible damage that may affect safety or performance. Do not use if damaged. Only qualified technicians should perform maintenance. Use only specified devices and accessories.

Cautions
Do not use the Oximeter in environments with inflammable gases or during MRI/CT scans. Avoid prolonged use on the same spot to prevent discomfort. Do not clip on edema or tender tissue. Keep away from eyes as emitted light can be harmful.

Warnings
Discontinue use if discomfort occurs. Do not stare at the emitted light. This device is not a treatment device. Follow local laws for disposal.

Attentions
Keep the Oximeter away from dust, vibration, corrosive substances, and moisture. Store out of reach of children. Stop use if the device gets wet.

FAQ

Q: Can the Oximeter be used for medical purposes?
A: No, the Oximeter is intended for sports and aviation use only, not for medical purposes.
Q: How often should I inspect the device?
A: It is recommended to inspect the device minimally before each use for any visible damage.
Q: What should I do if the Oximeter gets wet?
A: Stop using the device if it gets wet and seek guidance on proper handling.

Safety Instruction

Notes

It’s not a medical device. This device is for Sports and aviation use only and is not intended for medical use.
The contents contained in this manual are subject to change without notice.
Information furnished by our company is believed to be accurate and reliable. However, no responsibility is assumed by us for its use, or any infringements of patents or other rights of third parties that may result from its use.

Instructions for Safe Operation

Check the device to make sure that no visible damage may affect the user’s safety or measurement performance of sensors and clips. It isrecommended that the device should be inspected minimally before each use. If there is obvious damage, stop using the device.
Special attention should be paid while the Oximeter is used constantly under the ambient temperature of over 37 °C, burning hurt may occur because of overheating of of the sensor in this situation.
Necessary maintenance must be performed only by qualified service technicians. Users are not permitted to service this device.
The Oximeter must not be used with devices and accessories not specified in the User Manual.

Cautions

Explosive hazard—DO NOT use the Oximeter environment with inflammable gas such as some ignitable anesthetic agents.
DO NOT use the Oximeter while the user is under MRI or CT scanning. This device is NOT MRI-compatible.

Warnings

Discomfort or pain may appear if using the oximeter continuously in the same location for a long time, especially for users with poor microcirculation. It isrecommended that the Oximeter should not be applied to the same location for longer than 2 hours. If any abnormal condition is found, please change the position of the Oximeter.
DO NOT clip this device on edema or tender tissue.
The light (the infrared light is invisible) emitted from the device is harmful to the eyes. Do not stare at the light.
The Oximeter is not a treatment device.
Local laws and Regulations must be followed when disposing of the device.

Attention

Keep the Oximeter away from dust, vibration, corrosive substances, explosive materials, high temperatures and moisture.
The device should be kept out of the reach of children.
If the Oximeter gets wet, please stop using it and do not resume operation until it is dry and checked for correct operation. When it is carried from a cold environment to a warm and humid environment, please do not use it immediately. Allow at least 15 minutes for the Oximeter to reach ambient temperature.
DO NOT operate the button on the front panel with sharp materials or sharp points.
DO NOT use high-temperature or high-pressure steam disinfection on the Oximeter. Refer to Chapter 7 for instructions regarding cleaning and disinfection.
The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid. That means the equipment is protected against solid foreign objects of 12.5mm and greater, and protected against vertically falling water drops when the enclosure is tilted up to 15°.
Please pay attention to the effects of lint, dust, light (including sunlight), etc.

Declaration of Conformity

The manufacturer hereby declares that this device complies with the following standards:

IEC 60601-1: 2005+A1: 2012 -Part 1: General requirements for basic safety and essential performance;
ISO 80601-2-61: 2017 – Part 2-61: Particular requirements for basic safety and essential performance of pulse Oximeter equipment. It also follows the provisions of the council directive MDD 93/42/EEC.

Caution:
U.S. federal law restricts this device to sale or use by or on the order of a physician.

FCC Rules are specifically for PC-60NW
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

Overview

Appearance

$Wearpulse-POD1-W-Baby-Oxygen-Meter-Finger-Pulse-Oximeter-fig- $1$$

Note:
The appearance is for demonstration only, please refer to the oximeter you purchased.

Name and Model

Name: Fingertip Oximeter
Model:
POD-1a/POD-2a/POD-3a/POD-1/POD-2/POD-3/POD-1W/PC-60B/PC-60B1/PC-60B2/PC-60B3 /PC-60B5/PC-60NW-1/PC-60C/PC-60C1/PC-60C2/PC-60D/PC-60D2/PC-60E/PC-60N/PC- 60NW/
PC-60F/PC-60FW/PC-60A

Intended Use
This Fingertip Oximeter is intended for measuring the heart rate and oxygen level through a user’s finger. It is applicable for spot-checking the oxygen level and heart rate of adults. Models with external sensor options and over- limit Indication may be used for longer periods depending on the suitability of the sensor selected.

Feature List

Explanation of abbreviations:
“√”This function is available, “×” without this function. Display Type: X-Y-Z

Note:
The finger clips of PC-60D & 60D2 are suitable for small fingers, especially for pediatric users. The only difference between these two Oximeters is the battery type. PC-60D installs a rechargeable button cell battery which could be used many times after being charged by the charger.

Configuration of PC-XXXX Fingertip Oximeters

Model Function| POD- 1 W| 60N| 60NW

(Color)

| 60NW-1

(Dual)

| New 60D2
---|---|---|---|---|---
Display type| S-L-M| D-O-C| D-O-C| D-O-D| D-O- D

Oxygen level, Heart rate, PI

| Oxygen level, Heart

rate,

|

√

|

√

|

√

|

√

Plethysmogram| ×| √| √| √| √
Pulse bar| √| √| √| √| √
Auto on| √| √| √| √| √
Auto-off| √| √| √| √| √
Setting menu| ×| √| √| √| ×
Pulse beep| ×| √| √| ×| ×
Low voltage indication| √| √| √| √| √
Four directions

display

| 2| √| √| √| √
Orientation-

sensor

| ×| ×| √| ×| ×
External probe

connection

| ×| ×| √| ×| ×
Wireless function| √| ×| √| √| ×

Description:

Indication sound mute
For the model with both the over-limits indication function and pulse beep function, when the beep is on and over-limitsindication sound is activated, the Display key will work as the mute key, and short time pressing it can mute the over-limitsindication sound and pulse beep for 90 seconds.

Measuring mode

Spot check mode: the measurement starts automatically when the finger is inserted into the finger clip properly, the measuring time lasts 30 seconds with an accounting-down indication. The oxygen level and heart rate readings will freeze at the end of 30 seconds, and the analysis result for the pulse rhythm will be displayed on the screen as well. Once the finger is out, the display will be cleared and the Oximeter shuts down automatically.
Continuous mode: the measurement starts automatically when the finger is inserted into the finger clip properly, the measuring never ends up along with oxygen level and heart rate readings update until the finger is out, then causing the Oximeter to shut down automatically.

Record list

a single group of stable readings will be recorded in the record list each time when the Oximeter shuts down regardless of spot-check or continuous mode. However, if the time from displaying valid readings to the end of measurement is less than 5 seconds, then no recording will be done.
up to 12 groups of records can be stored in the record list, the newest record is marked as M1, and the oldest record is marked as M12. The new record will override the previous record.
if the batteries are removed from the device, then the records will be not kept or volatile.
on power off status, long pressing the Display key brings up the record recall screen. On the record recall screen, a short time pressing the Display key can shift the records display, and if there is no key operation for 6 seconds, then the Oximeter will power off automatically again.

Battery Installation

Refer to Figure 3, insert two AAA-size batteries into the battery compartment properly, and note the polarity markings.
Replace the cover.

Please make sure that the batteries are correctly installed. Incorrect installation may cause the device not to work.

Figure 3 Battery Installation

Please remove batteries if the device is not being used for more than 7 days to prevent and avoid potential damage from battery leaking. Any such damage is notcovered under the product warranty.

External Oxygen Level Probe Connection

Connect the external oxygen level probe to the oxygen level sensor connector as shown below. Ensure the “Arrow” faces upwards.

Note:
When the external oxygen level probe is connected, the built-in finger clip sensor will be disabled. The measurement is detected from the external oxygen level probe. Default over-limit indication settings for oxygen level and heart rate will change to Oxygen level Low limit: 95%

Heart rate high limit: 160bpm
Low limit: 60bpm

Operation

Open the clip and put the finger inside the rubber cushions of the clip (make sure the finger is in the correct position), and then clip the finger, asshown in Figure 5
Wait 2 seconds, the Oximeter will power on automatically and start to measure;
Next, enter into the data display screen:
POD-1, POD-2 & POD-3 display screens are shown in Figure 6.
Note: the display direction of POD-1a, POD-2a &POD-3a is up and down.
PC-60B display screen as shown in Figure 7. $Wearpulse-POD1-W-Baby-Oxygen-Meter-Finger-Pulse-Oximeter-fig- $7$$
For PC-60B, short time press the Display Key to turn on/offthe backlight. Longtime press Display Key to display PI asshown in Figure 7B, after 8 seconds, the screen will return the screen as shown in Figure 7A.
For other types of Oximeter PC-60B1, PC-60B2, PC-60B3, PC-60B5, PC-60C, PC-60C1, PC-60C2, PC-60D and PC-60D2, short time press Display Key to change display direction, as shown in figure 8A& 8B (Note: 60C1 changes direction automatically, and 60C and 60C1 without pulse bar); Longtime press Display Key to shift the parameter display between heart rate and PI. Please refer to Figure 8C.
For POD-1W, the display screen is as shown in Figure. $Wearpulse-POD1-W-Baby-Oxygen-Meter-Finger-Pulse-Oximeter-fig- $8$$
Note:

  * The PI% display will be shifted back to the heart rate display automatically after 20 seconds even if no button operation.
  * For the model PC-60B3, there is no plethysmogram display while the display direction is shifted to the right or left direction, as shown in Figure 8D; On the opposite, PC-60B1 has no plethysmogram on the default measuring screen as shown in figure 8E, while the display direction is shifted to left side direction, there will be displayed plethysmogram please refer to figure 8F.
  * The models PC-60B2 & 60B5, only have two change directions: up and down.
  * For a model PC-60C, the measuring screen is shown in big font, then there is no pulse bar shown.
  * For PC-60E, when changing the display direction, the PI value will automatically display on the device instead of the heart rate value, the heart rate value will be restored after 20 seconds.
  * For PC-60N and PC-60NW, pressing the display key can shift the rate and PI.
  * For PC-60E, an upward/downward shift of the Oximeter can quickly turn on/off the pulse beep. The default pulse beep is OFF.
6. For New PC-60D2, the default measuring screen is asshown in Figure 9A, short time press the Display Key to change direction, as shown in Figures 9A, 9B, 9C, & 9D; Longtime press the Display Key to shift the parameter display between heart rate and PI, as shown in figure 9E.
7. For PC-60A, the display screen is as shown in the below figure.
8. Description for PC-60F and PC-60FW
  * short time press Display Key can change display direction, the four display directions are as shown in Figure 10A, 10B, 10C, & 10D. For display screens of Figure 10B and 10D, the PI% display value will be replaced with the heart rate display value after 20 seconds if no key of operation.
  * For PC-60F and PC-60FW, the display direction is remembered at each startup, that is, the screen layout (display direction) of the last time will be used as the initial screen layout when powering on the Oximeternext time.
  * The only difference between PC-60F and PC-60FW is that PC-60F has no wireless function and thus no wireless icon on the screen.
  * Icon “ “on the display screen means the counting-down time if the Oximeter works at Spot check mode. The total measuring time for Spot check mode is 30 seconds.
  * When the measurement ends up for Spot check mode, the measured oxygen level, heart rate value and the analysis result of pulse rhythm will be displayed on the screen, as shown in Figure 10E.

For other result descriptions see Appendix I.
Recording & recall functions are available for PC-60F and PC-60FW. At power off status, a long time pressing the Display key can bring up a record list display screen, as shown in Figure 11. In the record list screen, short time press the Display key to shift the records page.

9. Menu (PC-60C1, PC-60N, PC-60NW-1 Dual, PC-60NWColor, PC-60F and PC-60FW) Long-time pressing display key can enter the setup menu screen.![Wearpulse-POD1-W-Baby-Oxygen-Meter-Finger-Pulse-Oximeter-fig- \(15\)](https://manuals.plus/wp-content/uploads/2024/03/Wearpulse-POD1-W-Baby-Oxygen-Meter-Finger-Pulse-Oximeter-fig-15.png)
  *  **“Wireless”:** the wireless on-off button. Transmitting data to PC when it is on. “on” and “off” can be optional. The factory default is “on”.
  *  **“Pulse beep”/“Beep”:** Pulse beep option. If it is set to on, every pulse beat makes a beep. Only for model PC-60NW, the pitch tone of this beep changes according to oxygen level value (within 90~99%).
  *  **“Mode”:** to set the measuring mode. “Continuous” and “Spot check” for optional, the default is “Spot check”.
  *  **Menu setup:** Short time press Display Key to choose the setting item; Long time press Display Key to activate the setting item, then short time press it to modify the setting parameter; Next, press Display Key to confirm the modification and exit from this setting item. At last, move the setting item to “Save, exit menu”, and long time press the Display Key to store the modification and exit from the setup menu.![Wearpulse-POD1-W-Baby-Oxygen-Meter-Finger-Pulse-Oximeter-fig- \(16\)](https://manuals.plus/wp-content/uploads/2024/03/Wearpulse-POD1-W-Baby-Oxygen-Meter-Finger-Pulse-Oximeter-fig-16.png)

Note: if a wireless connection is set up, the icon “ ” will be displayed on the screen.

Wireless icon“ ”/” “:

Data transmission
The user could effectively transmit the data to a computer through the wireless function. Refer to the “Oximeter DataManager” for detailed information.

Attention to the operation

The finger should be put into the sensor correctly.
Do not shake the finger and relax during measurement.
Do not put wet fingers directly into the sensor.
Avoid placing the device on the same limb which is wrapped with a cuff for blood pressure measurement during venous infusion.
Do not let anything block the emitting light from the device, i.e. do not use fingernail polish/paints.
Vigorous exercise and electrosurgical device interference may affect the measuring accuracy.
For model PC-60E, the orientation sensor works based on gravity. A small movable metal ball is built into the orientation sensor for detecting the orientation of the Oximeter. When you want to change the Oximeter’s display direction, if you move the Oximeter too slowly, the movable metal ball will also move slowly because of not enough acceleration. Consequently, the response of orientation detection would be delayed. Acceleration needs to be provided by the orientation sensor for quick sensing of the orientation change.
Nail polish may affect the measuring accuracy, and too-long fingernails may cause the failure of measurement or inaccurate results.
The existence of highly intensive light sources, such as fluorescence light, ruby lamb, infrared heater strong sunshine, etc. may cause inaccuracy of measurement results. Please put an opaque cover on the sensor or change the measuring site if necessary.
If the first reading appears with poor waveform(irregular or not smooth), then the reading is unlikely true the more stable value is expected by waiting for a while, or a restart is needed when necessary.

Note:
Due to the working principle of the orientation sensor used in Oximeters, such as the model PC-60E, there is a small metal ball that is movable within its compartment of the orientation sensor. Therefore you may hear a slight “clatter” sound when you wave or shake the Oximeter, this is normal!

Download the APP software

The Terminal devices such as Android smartphones can be used to receive data from the Oximeter in real-time, and store the received data, review the stored data as well. You have to download the corresponding APP software on your smartphone. Please follow the procedure to download:

Search “ViHealth” in Google Play (for Android users) or Apple Store (for iOS users).
Once the search results are listed, select the App name” ViHealth ” with an icon , then download it from the App software.

You can also scan the QR code below for downloading and installation.

NOTES:

The APP software is only applicable to the Fingertip Oximeter with wireless function.
Please make sure the version of the Android system for your smartphone is V4.3 or higher and includes the wireless module of V4.0, otherwise, the downloaded APP software will not be compatible with the Oximeter.
If you use an iPad to search, please select “iPhone only” as well for searching.
Please make sure the APP software performs a successful wireless connection with the Oximeter.

Instruction for Measurement

Make sure the APP software is successfully connected to the Oximeter.
Refer to the manual of this APP software for detailed operation.

Technical Specifications

Oxygen level Measurement
- Transducer: dual-wavelength LED sensor with wavelength:
- Red light: 663 nm, Infrared light: 890 nm.
- Maximal average optical output power: ≤2mW
- Oxygen level display range: 35%~99%
- Oxygen level measuring accuracy: ≤ 2% for oxygen level range from 70% to 100%
Heart rate measurement
- Heart rate display range: 30bpm~250bpm
- Heart rate measuring accuracy: ±2bpm or ±2% (whichever is greater)
Perfusion Index (PI) Display range 0.2%~20%
Preset over-limits
- Oxygen level low limit: 90%
- Heart rate: high limit: 120bpm low limit: 50bpm
Over-limit indication settings for PC-60C1,N,NW:
- Oxygen level: low limit setting range: 85%~95%
- Default setting: 85%
- Heart rate:
- Low limit setting range: 30~60bpm;
- High limit setting range: 100~240bpm;
- Default setting: high: 120bpm; low: 50bpm
Over-limit settings for PC-60F, PC-60FW
- Oxygen level: low limit setting range: 85%~99%, step: 1%
- Default setting: 90%
- Heart rate:
- Low limit setting range: 30~60bpm, step: 1bpm;
- High limit setting range: 100~240bpm, step: 5bpm;
- Default setting: high: 120bpm; low: 50bpm
Over-limit settings for PC-60E
- Oxygen level: default low over-limit:
- For internal sensor: 90%
- For external sensor: 95%
- Heart rate: For internal sensor:
- High limit: 120bpm;
- Low limit: 50bpm
- For external sensors:
- High limit: 160bpm;
- Low limit: 60bpm
Reminder function
When measuring, if the oxygen level value or heart rate value exceeds the preset limit, the device will beep automatically and the value that exceeds the limit will flash on the screen.
Power supply requirement: 2 x LR03 (AAA) alkaline batteries
- Supply voltage: 3.0VDC
- Operating current: ≤40mA
Environmental Conditions:
- Operating Temperature: 5°C ~40°C
- Operating Humidity: 30%~80%
- Atmospheric pressure: 70kPa~106kPa
Low Perfusion Performance:
The accuracy of oxygen level and heart rate measurement still meets the precision described above when the modulation amplitude is as low as 0.6%.
Ambient Light Interference:
The difference between the oxygen level value measured in the condition of indoor natural light and that of darkroom is less than ±1%.
Dimensions:

1. 60 mm (L) × 33 mm (W) × 30 mm (H) (for POD series)
2. 59 mm (L) × 34 mm (W) × 30 mm (H) (for 60B series)
3. 66 mm (L) × 36 mm (W) × 33 mm (H) (for 60C series)
4. 60 mm (L) × 39 mm (W) × 32 mm (H) (for 60D series)
5. 61 mm (L) × 34 mm (W) × 33 mm (H) (for 60E)
6. 56 mm (L) × 34 mm (W) × 30 mm (H) (for 60F/60FW/60A)
  * Net Weight: approx. 60g

Classification
- The type of protection against electric shock: Internally powered equipment.
- The degree of protection against electric shock: Type BF applied parts.
- The degree of protection against harmful solid foreign objects and ingress of liquid:
  The equipment is IP22 with protection against harmful solid foreign objects and ingress of liquid.
- Electro-Magnetic Compatibility: Group I, Class B

Packing List

Fingertip Oximeter
User Manual
Batteries
Pouch (Optional)
Lanyard (Optional)
External oxygen level probe (Optional)

Note:
The items and their quantity are subject to change, please refer to your subject in hand.

Repair and Maintenance

Maintenance
The expected service life (not a warranty) of this device is 5 years. To ensure its long service life, please pay attention to the maintenance.

Please change the batteries when the low-voltage indicator lightens.
Please clean the surface of the device before using, it with 75% alcohol wipes, then let it air dry or wipe it dry. Do not allow liquid to enter the device.
Please take out the batteries if the Oximeter will not be used any more than 7 days.
The recommended storage environment of the device: ambient temperature: -20ºC ~60ºC, relative humidity 10%~95%, atmospheric pressure: 50kPa~107.4kPa.
The Oximeter is calibrated in the factory before sale, so there is no need to calibrate it during its life cycle. Any oxygen level simulators should not be used to validate the accuracy of the Oximeter, they can only be used as functional testers to verify its precision. The oxygen level accuracy claimed in this manual is supported by the clinical study conducted by inducing hypoxia on healthy, non-smoking, light-to-dark-skinned subjects in an independent research laboratory.
If it is necessary to verify the precision of the Oximeter routinely, the user can do the verification using an oxygen level simulator, or it can be done by the local third-party test house. Please note that the specific calibration curve (so-called R-curve) should be selected when using of oxygen level simulator, e.g. for the Index 2 series oxygen level simulator from Fluke Biomedical Corporation, please set “Make” to “DownLoadMake: KRK”, then the user can use this particular R-curve to test the Oximeter. If the oxygen level simulator does not contain the “KRK” R-curve, please ask the manufacturer for helping to download the given R-curve into the oxygen level simulator.
- High-pressure sterilization cannot be used on the device.
- Do not immerse the device in liquid.
- It is recommended that the device should be kept in a dry environment. Humidity may reduce the life of the device, or even damage it.

Cleaning and Disinfecting Instruction

Surface-clean sensor with a soft cloth damped with a solution such as 75% isopropyl alcohol, if low-level disinfection is required, use a mild bleach solution.
Then surface-clean with a cloth damped ONLY with clean water and dry with a clean, soft cloth.

Caution:

Do not sterilize by irradiation steam or ethylene oxide.
Do not use the Oximeter if it is damaged.

Troubleshooting

Problem:

The oxygen level and heart rate display unstable
Can not turn on the device
No display
Display direction doesn’t change or changes insensitively. (such as model PC-60E)
No display of the wireless icon “ ”

Solution

Place the finger correctly inside and try again.
Changing batteries.
Let the user keep calm.
Please shake the Oximeter with a certain force to make the movable metal ball move freely. If the problem still exists, maybe the orientation sensor is not working properly.
Hardware failure of wireless transmission function.
If the above problem still exists please contact the local service center.

Key of Symbols

$Wearpulse-POD1-W-Baby-Oxygen-Meter-Finger-Pulse-Oximeter-fig- $20$$

Frequently Asked Questions

Q: What’s the oxygen level?
A: Oxygen level means the saturation percentage of oxygen in the blood.
Q: What’s the normal range of oxygen level values for healthy people?
A: The normal range varies by individual, but is usually over 95%, otherwise, please consult your physician.
Q: What’s the normal range of heart rate values for healthy people?
A: Usually, the normal range is 60bpm~100bpm.
Q: Why do the display values of oxygen level and heart rate vary with time?
A: The measured oxygen level and heart rate value change in correspondence with the change in the user’s physiological conditions.
Q: What to do if there is no oxygen level and heart rate reading?
A: Do not shake the finger, and keep calm during the measurement. Please also avoid the Oximeter and the cuff on the same limb for blood pressure and oxygen saturation measurement simultaneously.
Q: How to confirm that the oxygen level reading is true or accurate?
A: Hold breath for a while (50 seconds or more), if the oxygen level value significantly decreases, it means that the oxygen level reading truly reflects the physiological condition change.
Q: When to replace the batteries?
A: The icon of low battery will appear on the screen when the battery voltages are low. By then, the batteries need to be replaced.
Q: What to do if the Oximeter is moistened or sprayed with water?
A: Remove the batteries immediately and dry the Oximeter completely with a hair dryer.
Q: What factors will affect the oxygen level accuracy?
A:
- Intravascular dyes such as indocyanine green or methylene blue;
- Exposure to excessive illumination, such as surgical lamps, bilirubin lamps, fluorescent lights, infrared heating lamps, or direct sunlight;
- Vascular dyes or externally used colour-up products such as nail enamel or colour skin care;
- Excessive user movement;
- Placement of a sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line;
- Exposure to the chamber with High-pressure oxygen;
- There is an arterial occlusion proximal to the sensor;
- Blood vessel contraction caused by peripheral vessel hyperkinesias or body temperature decreasing;
- Low perfusion condition (Perfusion Index is small).

Please contact the local distributor or manufacturer if necessary.

FCC Statement

FCC Warning:

FCC ID: A49PC-60NW
Any Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. 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.

Note:
This equipment has been tested and found to comply with the limits for a Class B digital device, under 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 by 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 the 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 exposure conditions without restriction.

Appendix

Result Description

No irregularity found
Suspected a little fast pulse
Suspected fast pulse
Suspected short run of fast pulse
Suspected a little slow pulse
Suspected slow pulse
Suspected occasional short pulse interval
Suspected irregular pulse interval
Suspected fast pulse with short pulse interval
Suspected slow pulse with short pulse interval
Suspected slow pulse with irregular pulse interval
Poor signal. Measure again

EMC

Note:

Warnings:

The instrument conforms to the requirements of IEC60601- 1 – 2, EN 60601-1-2 and ISO 80601-2-61 standards for electromagnetic compatibility.
The user shall install and use the EMC information provided in the random file.
Portable and mobile RF communication equipment may affect the performance of the instrument, avoid strong electromagnetic interference when using, such as close to the mobile phone, microwave oven, etc.
The guidance and manufacturer’s declaration are detailed in the table below.
The instrument should not be close to or stacked with other equipment. If it is to close to or stacked, it should be observed and verified to be able to operate normally under its configuration.
In addition to the cables sold by the instrument manufacturer as spare parts for internal components, the use of other accessories and cables may result in increased emissions or reduced immunity.

Table 1

Guidance and manufacturer’s declaration-electromagnetic

emission

The Fingertip Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Fingertip Oximeter should

assure that it is used in such an environment.

Emissions test| Compliance| Electromagnetic environment-

guidance

Group 1 Class B

| internal function. Therefore, its RF emissions are very low and are not

likely to cause any

| | interference in
| | nearby electronic
| | equipment.
Radiated emissions| | The Fingertip Oximeter is suitable for use in all establishments, including domestic establishments and those direct network that supply buildings used for domestic

purposes.

Table 2

Guidance and manufacturer’s declaration-electromagnetic emission

The Fingertip Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of the Fingertip Oximeter should

assure that it is used in such an environment.

Immunity test| IEC60601

test level

| Compliance level| Electromagnetic environment –

guidance

Electrostatic discharge(ESD) IEC61000-4-2

| ****

±8 kV

contact

±2 kV, ±4

kV, ±8 kV,

± 15 kV air

| ****

±8 kV

contact

±2 kV, ±4

kV, ±8 kV,

± 15 kV air

| Floors should be wood, concrete or ceramic tile. if floors are covered with synthetic material, the relative humidity should be at least

30%

Electrical fast transient/ burst IEC61000-4-4

| ±2kV for power Supply lines

±1kV for Input a.c. Power

Ports

| ±2kV for power Supply lines

±1kV for Input a.c. Power

Ports

| ****

N/A

Surge

IEC 61000-4-5

| ±0.5 kV,

1kV line (s) to line(s)

±0.5 kV, ± 1 kV, ±2kV

line(s) to

earth

| ±0.5 kV,

1kV line (s) to line(s)

±0.5 kV, ± 1 kV, ±2kV

line(s) to

earth

| ****

N/A

Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11

| <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 in UT) for

5 s

| <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 in UT) for

5 s

| ****

N/A

Power frequency( 50Hz/60Hz) magnetic field IEC61000-4-8

| ****

30A/m

| ****

30A/m

| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical

commercial.

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

Table 3

Guidance and manufacturer’s declaration – electromagnetic immunity
The Fingertip Oximeter is intended for use in the electromagnetic environment specified below. The customer or the user of The Fingertip Oximeter should assure that it is used in such an electromagnetic environment.

Immunity test| IEC60601 test level| Compliance level| Electromagnetic environment – guidance
---|---|---|---

Conducted RF IEC61000-4- 6

Radiated RF IEC61000-4- 3

| ****

0,15MHz–

80MHz

3 V RMS

outside the ISM band, 6 V RMS in the ISM

80 MHz to

2.7 GHz 3V/m

| ****

0,15MHz–

80MHz

3 V RMS

outside the ISM band, 6 V RMS in the ISM

80 MHz to

2.7 GHz 3V/m

| Portable and mobile RF communications equipment should be used no closer to any part of The Fingertip Oximeter, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance d=1.2 P

d=1.2 P 80MHz to

800MHz

d=2.3 P 800MHz

to 2.5GHz 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). b

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range .b Interference may occur in the vicinity of equipment marked with the wing symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations.

Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a: Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcasts 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 Fingertip Oximeter is used exceeds the applicable RF compliance level above, The Fingertip Oximeter should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating The Fingertip Oximeter.

b: Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 3V/m.

Table 4

Frequency Range and Level: RF wireless communication

equipment

Test Frequency (MHz)| ****

Modulation

| Minimum immunity Level

(V/m)

| immunity Level Applied

(V/m)

385| **Pulse Modulation:

18 Hz

| 27| 27
450| | | *FM + 5 Hz| 28| 28
deviation: 1 kHz sine

**Pulse

Modulation: 18 Hz

710

745

780

| **Pulse Modulation: 217 Hz| 9| 9
810

870

930

| **Pulse Modulation: 18 Hz| 28| 28
1720

1845

1970

| Pulse Modulation: 217 Hz| 28| 28
2450| Pulse Modulation:

217 Hz

| 28| 28
5240

5500

5785

| **Pulse Modulation: 217 Hz| 9| 9
ATTENTION:

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 m. The 1

m test distance is permitted 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 while it does not represent actual modulation, it would be worst case.

Table 5

Recommended separation distances between portable and

mobile RF communication the equipment

The Fingertip Oximeter is intended for use in an

electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of The Fingertip Oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Fingertip Oximeter as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter W(Watts)| Separation distance according to frequency

of transmitter M(Meters)

| |
0,01| N/A| 0.12| 0.23
0,1| N/A| 0.38| 0.73
1| N/A| 1.2| 2.3
10| N/A| 3.8| 7.3
100| N/A| 12| 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance in metres (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

$Wearpulse-POD1-W-Baby-Oxygen-Meter-Finger-Pulse-Oximeter-fig- $26$$

Manufacturer:

Shenzhen Creative Industry Co., Ltd.
Floor 5, BLD 9, Baiwangxin High-Tech Industrial Park, Songbai Road, Xili Street, Nanshan District, 518110 Shenzhen, P. R. China.
E-mail: service@iwearpulse.com
Website: www.iwearpulse.com.