Kaiyan ZLD-05 Lumaflex Panel User Manual

Kaiyan ZLD-05 Lumaflex Panel

Specifications:

• Model: ZLD-05
• Company Name: Shenzhen Kaiyan Medical Equipment Co., Ltd
• Company Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China
• Manual Version: V1.0
• Issue Date: 2023-09-22
• File No.: KY-ZLD05-UM-001

Product Description:

The Lumaflex Panel is a medical device designed for specific treatments. It utilizes LEDs and advanced technology to provide therapeutic benefits.

Recommendation of Use

Please read the complete instruction manual before using the Lumaflex Panel. It will give you a better understanding of how the product works, and you’ll be able to enjoy the best treatment results.

Warnings

1. Do not stare directly at the LEDs.
2. Do not use the device if it appears to be operating incorrectly, and contact customer support.
3. Do not use the device in combination with muscle heating cremes or other medications which may result in damage to skin tissue.
4. Do not expose any parts of the device to chemical solvents or harsh cleaning fluids.
5. The device contains silicon and plastics that come into contact with the skin during use.

Using Instructions:

1. Ensure the device is plugged into a power source.
2. Place the Lumaflex Panel at a suitable distance from the treatment area.
3. Turn on the device using the power button.
4. Select the desired treatment mode using the control panel.
5. Follow the recommended treatment time for optimal results.
6. After use, turn off the device and unplug it from the power source.

FAQ:

• Q: Can the Lumaflex Panel be used on all skin types?
  • A: The Lumaflex Panel is suitable for most skin types, but it’s recommended to perform a patch test before full treatment to ensure compatibility.
• Q: How often should I use the Lumaflex Panel?
  • A: The frequency of use depends on the specific treatment plan. Please refer to the instruction manual for guidance on treatment frequency.
• Q: Is it safe to use the Lumaflex Panel near electronic devices?
  • A: To avoid interference, it’s recommended to use the Lumaflex Panel away from high-frequency surgical units, X-ray devices, and other sources of electromagnetic radiation.

Recommendation of Use

Please read the complete instruction manual before using theLumaflex Panel. It will give you a better understanding of how the product works, and you’ll be able to enjoy the best treatment results.

Warnings

1. Do not stare directly at the LEDs.
2. Do not use the device if it appears to be operating incorrectly, and contact customer support.
3. Do not use the device in combination with muscle heating cremes or other medications which may result in damage to skin tissue.
4. Do not expose any parts of the device to chemical solvents or harsh cleaning fluids.
5. The device contains silicon and plastics that come into contact with the skin during use. Do not use the device if you have a known allergic reaction to contact with silicone or plastics.
6. Avoid fluids on the light panel and controller. Discontinue use if there are water in the device.
7. Opening or altering the device may damage the operating circuits and will result in voiding the warranty.
8. Before installing or using the device or system, keep an appropriate distance from radio frequency (RF) sources whenever possible. The sources include but not limit to:
   • Radio and TV stations
   • Portable and mobile RF communication devices (cell phones, two-way radios, base station, etc.)
   • High-frequency surgical units, such as diathermy, electrocautery, argon beam coagulators, etc.
   • X-ray, CT, or MRI devices
   • These devices are also possible sources of interference as they may emit higher levels of electromagnetic radiation.
9. 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.
10. 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 Lumaflex Panel device or system, including cables specified by the manufacturer. Degradation of the performance of this equipment could result.
11. Use of accessories, transducers and cables other than those specified or provided by the Shenzhen Kaiyan Medical Equipment Co., Ltd manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
12. Magnetic and electric fields may interfere with the performance of the device or system. Make sure that all peripheral components operated in the vicinity of the device comply with the relevant EMC requirements. X-ray equipment, MRI devices, radio systems (cellular phones) and so forth, are possible sources of interference because they may emit higher levels of electromagnetic radiation. Verify the performance of the system before use.
13. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
14. 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:
15. Reorient or relocate the receiving antenna.
16. Increase the separation between the equipment and the receiver.
17. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
18. Consult the dealer or an experienced radio/TV technician for help
19. 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.

Contraindications

• Do not use the device if you are under the age of 22.
• Do not use the device if you have the Fitzpatrick Skin in Type V and Type VI.
• Do not use this device if you have any photosensitive disorders or genetic conditions of the eye.
• Do not use the device if you are pregnant, breastfeeding, or preparing to get pregnant.
• Do not use the device on infants or children.
• Do not use the device if you have a medical history of seizures that were triggered by light.
• Do not use the device if you are taking photosensitive drugs.
• Do not use the device over malignant and nonmalignant tumors.
• Do not use the device over open or bleeding wounds.
• Do not use the device if you have or may have heart disease.
• Don not use the device over area with phlebitis, thrombophlebitis and varicose veins.

Adverse Reactions

If you have any adverse reaction to this device, stop using it immediately. Note: If you experience any discomfort, such as skin discoloration, skin damage, or any other concerns develop, stop using the device immediately and consult your physician.

Precautions

• Discontinue use if the device overheats or becomes uncomfortably hot.
• Use only the supplied Universal charging cable. The use of an incorrect power cord could damage the device.
• Contact your doctor if you have any medical questions regarding the use of this device.
• Clean the device termly to avoid cross-infection.
• Do not continuously press the ON/OFF button and this is an invalid operation.
• This device contains a Lithium Battery. Before disposal of this device, please review your local laws and requirements surrounding Lithium Battery disposal. The preferred method of disposal is recycling.
• It will void your warranty if you do not operate the device per the manual’s instructions.
• Store the device according to the protocol worked out in this manual.
• Inspect the device, and do not use the device if you see any signs of internal battery leaks. Contact our customer support.
• The normal function of the product may be disturbed by solid electromagnetic Interference. If so, reset the product to resume normal operation by following the instruction manual. Please use the product in another location if the function cannot resume.”
• The device should only be used with manufacturer-approved accessories.
• Opening or altering the device may damage the operation circuits and will result in voiding the warranty.
• If your device requires repair or service, please contact customer support.
• Use a 5V adapter to charge the device before it can be charged normally.

Indications for Use

The device has hair growth, wrinkle removal and pain relief function.

• Promote hair growth in males with androgenic alopecia who have NorwoodHamilton classifications of IIa-V and females with androgenic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I-IV.
• Use in the treatment of full-face wrinkles.
• Deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

Product Description

The Lumaflex Panel, model: ZLD-05, is an over-the-counter light-emitting diode (LED) device. It has three modes, and it can emit 650±20nm light to promote hair growth, emit 650+/-20nm + 850nm light to treat wrinkles and relieve pain. The user can turn on the device by press the on/off button, and set treatment time and modes through an App. The device will shut off automatically within a set time. The Lumaflex Panel components include a light panel, a controller, a charging cable, a short strap, a long strap, a cleaning cloth and goggles. User needs to download APP LumaFlex which connects the device via Bluetooth to set treatment time and mode. And the device is powered by the controller

Specification

Basic Specification

Produce name| Lumaflex Panel
Model| ZLD-05

Power source

| Externally charging by USB input: 5Vdc, 2.0A Internally powered by 3.7Vdc, 5200mAh, 19.24Wh lithium battery
Dimensions(LWH)| 253 x 158 x 35.7 mm
Energy Source| LEDs
Weight (only main unit)| 0.47kg
Number of LEDs| 45
Wavelengths| 650±20nm, 850nm

Treatment time

| Mode 1 – Hair Growth:

20mins daily 5 days per week for 16 Weeks Model 2 – Treat Wrinkles:

10mins daily 5 days per week for 10 Weeks Mode 3 – Relieve Pain:

15mins daily 5 days per week for 6-8 Weeks

Environment of Use| OTC
Risk group according to IEC 62471:2006| Risk Group 1

Safety and EMC

| IEC 60601-1

IEC 60601-1-2

IEC 60601-1-11

IEC 60601-2-57

IEC 62471

IEC 62133-2

Biocompatibility| ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO

10993-23

Operating Environment

| Temperature: 0~50°C Humidity: 30-95%RH

Atmospheric Pressure: 700hPa-1060hPa

---|---

Storage Environment

| Temperature: 0~50°C Humidity: 30-95%RH

Atmospheric Pressure: 700hPa-1060hPa

Accessories List

Explanation:

1 ON/OFF button| Press and hold 2 seconds to turn on/off the device;

When the device is turned on, quickly press the ON/OFF button to start the treatment

While working, press the ON/OFF button to pause the treatment.And press the button again to continue the treatment

---|---
2,4 Lumaflex logo| When the device is turned on, it will light on. When a treatment is finished, it will blink twice. When charging, it will blink.

When the battery is low, it will blink. When fully charged, it will stay on.

3 Vibration| The device will vibrate for a few seconds after it is turned on/off. The device will vibrate shortly if a treatment is activated wit the button.

The device will vibrate shortly twice after a treatment is finished.

Using Instructions

Check for these situations before the use

1. Please distinguish your skin types according to the table below before use, which will provide more effective instructions for your choice. Fitzpatrick Skin Types I-IV should only use the device:

Note: The “X” means “not suitable”!Please don’t use the device if you have Fitzpatrick Skin in Type V or Type VI!

Light sensitivity test

Follow the instructions below to check if you are light-sensitive:

1. Place the device on your skin;
2. Turn on the device;
3. Set an alarm for 5 minutes;
4. After 5 minutes, turn off the device and remove it from the skin;
5. Check if the treatment area has turned red. If your skin turns red within 48h, don’t use the device your skin is sensitive to light.

First Use and Preparation

• Take out and check the device and accessories Take out a light panel, controller, a charging cable, a short strap, a long strap, a cleaning cloth from the box. Check whether any of the components are missing or damaged, if have please contact Lumaflex customer support.
• Charging for your device Connect the type C port of the charging cable to the device, and the type A port of the charging cable to the adapter.

Note:

• Charge your device before first use and when the battery is empty.
• The device should only be charged with the accompanied charging cable in combination with a 5V 2A USB charger;
• When charging, lumaflex logo will slowly blink;
• When fully charged, lumaflex logo will be steady red;
• When the battery level is low, lumaflex logo will blink.

Put the controller on the light panel

• Put the controller on the light panel through 4 magnetic pins.

APP download (The APP is only used in IOS system)

• Search LumaFlex in Appstore and download it;
• Recommended treatment site

When using the device to promote hair growth, using a long strap or short strap to secure the device on your head.

• When using the device to treat wrinkles, hold the controller in your hand and treat with the treatment face facing your face. (In this treatment mode, please wear goggles.)
• When using the device to relief pain, please fix the device according to the following recommended positions

Note: 1. Do not secure too tightly, restricting blood flow or breathing. 2. Never stare directly at the LEDs.

Operation Instructions

1. Clean the treatment area
   • Clean the treatment area, before using the device, and make sure the treatment area is free of any cremes or other topicals.
2. Wear goggles
   • Wear goggles, especially when treating the face.
3. Wear the device
   • Put the device in your treatment area.
   • Select the appropriate strap to wrap and fix the device and treatment parts. (See the 5.4 for details.)
4. Turn on the device
   • Turn on the device by pressingthe ON/OFF button for 2 seconds.
5. Treatment before connecting the APP
   • Press the ON/OFF button again, the device can emit red light to treat wrinkles without connecting the APP. The treatment time is 10 mins.
6. Connect the APP and the device
   • Turn on system Bluetooth on your phone (See figure 4.6-1);
   • Press ON/OFF button to turn on the device.
   • Open the app and click “Search & Connect” to search for nearby devices. (See figure 4.6-2)
   • Click the searched device, see figure 4.6-3. If connect successfully, the interface will skip to mode selection, see figure 4.6-4.

Note: Before connecting the device, you can click “TARGET AREAS” to see how to wear the device. See Figure 4.6-4.

Select the treatment mode on APP

• Click the treatment mode on the APP, see Figure 4.6-5. Then the device starts treatment and treatment time begins to count down, see figure 4.6-6.

Note: The default model is 10 mins and red light. Hair Growth: 20mins daily 5 days per week for 16 Weeks Treat Wrinkles: 10mins daily 5 days per week for 10 Weeks Relieve Pain: 15mins daily 5 days per week for 6-8 Weeks

• Stop treatment
  • Click “stop” on APP to stop treatment, see figure 4.6-6. Then the interface back to mode selection (figure 4.6-5).
• Turn off the device
  • Turn off the device in advance by long pressing the power button. Or it will automatically shut down when a setting time is over.
• Take off the device
  • Untie the strap and take down the device.
• Clean for the device (Please refer to Section 5.1 for details)
• Storage (Please refer to Section 5.2 for details)

Maintenance and Cleaning

Cleaning

After each use, it is recommended to clean the device.

• Turn the device off before cleaning the device.
• Clean the surface area and goggles of the panel with a damp cloth.
• Use a cotton swab dipped in WD-40 lubricant to clean 4 magnetic pins on both the light panel and controller.
• Wash the straps by hand and dry them in the sun.
• Visually check whether the device and goggles are still dirty. If yes, repeat the above cleaning steps.
• Clean the sunglasses with a soft cloth.

Note: Do not use cleaning sprays on the device, cleaning sprays could harm the light panel and controller.

Storing

• Lumafles panel is advised to be stored in the original package.
• Store in an environment with a temperature of 0~50°C, a humidity of 30-95%RH, and an atmospheric pressure of 700hPa-1060hPa.

Maintaining

To ensure the best effect and longest service life, please clean the device before and after use to avoid long-term accumulation of dust. If you do not clean normally, the product will not get the effect it should have. Before starting cleaning, the machine must be turned off and unplugged power to allow the machine to cool down. Wipe the panel with a damp cloth. Store the device in a dry and dust-free environment at 0 to 50°C.

Disposal of Electrical and Electronic Equipment Waste (E-waste)

As each city has its own regulation of the disposal of e-waste, please learn about recycling or disposal programs in your local area by searching “E-waste recycling or disposal” online. You can also contact the relative department in your city directly to consult the policy

Troubleshooting

the device.
The device is damaged.| –     Please get in touch with the nearest manufacturer for

depot repair.

The device is not charging| Charging cable is not connected firmly.| – Reconnect the charging cable and try again. If the battery indicator light is on, it indicates that charging can be carried out.

–          Try a different wall outlet to determine if there is power to the outlet.

–          Please get in touch with the nearest manufacturer for depot repair if

the above attempts fail.

Ensure that you are using a 5V adapter.

| –          If not, the device will not be able to charge.

–          If you use a 5V adapter for

charging and still cannot

| | charge successfully, please get in touch with the manufacturer and return it to

the factory for repair.

---|---|---
The device shuts off abruptly before the completion of the setting time treatment.| Overheated due to repeated use.| –          Wait for the device to cool, do not over- treat.

–          After the device cools down, turn it on again. If the situation still occurs, please get in touch with the manufacturer and return it to

the factory for repair.

The device shuts off abruptly after contacting high voltage.| This is the high voltage protection of the device itself, and it can be used after restarting.| –     If the device can’t be turned on, please get in touch with the manufacturer and return it to

the factory for repair.

Service

Do not try to disassemble or repair it. If the Lumaflex panel needs after-sale service, please contact Shenzhen Kaiyan Medical Equipment Co., Ltd.. All returned units to the manufacturer for repair, including Warranty repair and Out-Of-Warranty repair, must be in accordance with the following information:

• During the Warranty Period with proof of purchase (store receipt)

Package the item securely and return it prepaid/insured – along with proof of purchase to: Shenzhen Kaiyan Medical Equipment Co., Ltd Warranty Repair Department Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China To ensure prompt repair, please provide a complete, legible name, address, phone number, RMA number, a note indicating the problem with the product and a copy of the original purchase invoice of the unit. We will Repair or Replace (at our sole discretion) the product at no charge. Package the unit into the original container with all accessories and information as required above, then ship it back to the manufacturer.

Out-of-Warranty Scope

If the device is not damaged within the scope of the allowed warranty, the warranty will be invalid Any services to these devices shall be provided only by a Service Technician certified by Shenzhen Kaiyan Medical Equipment Co., Ltd.

ESSENTIAL PERFORMANCE

The essential performance of the system may be lost or degraded because of electromagnetic disturbances. For expected degradations and instructions of the basic safety and essential performance maintenance in the case of electromagnetic disturbances, see the table below:

Essential Performance| Degradation Caused by

Electromagnetic Disturbances

|

Essential Performance Maintenance

---|---|---
The main functions of the subject’s device, such as button function, indicator light display, LED light at the application site, working mode, and charging and overvoltage charging protection, can be

maintained in normal operation.

| No deviation| No deviation

Safety, EMC

This device complies with Medical EMC Standard IEC 60601-1-2:2014/2020.

Guidance and manufacturer’s declaration – electromagnetic emissions

This equipment is intended for use in the electromagnetic environments specified below, and the purchasers or users shall ensure that it is used in these electromagnetic environments.

Emissions| Compliance
RF emissions (Radiated) CISPR 11| Group 1 Class B
RF emissions (Conducted) CISPR 11| Not applicable
Harmonic emissions IEC 61000-3-2| Not applicable
Voltage fluctuations/flicker emissions

IEC 61000-3-3

| Complies
Guidance and manufacturer’s 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

| Compliance level| Environments
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

| HOME HEALTHCARE

environment

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

±1 kV for signal lines

| ±2 kV for power supply lines

±1 kV for signal lines

| HOME HEALTHCARE

environment

Surge

IEC 61000-4-5

| ± 0.5kV, ± 1 kV

line(s) to lines

± 0.5kV, ± 1 kV, ± 2

kV line(s) to earth

| ± 0.5kV, ± 1 kV

line(s) to lines

± 0.5kV, ± 1 kV, ± 2

kV line(s) to earth

| HOME HEALTHCARE

environment

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 at 0°

70% UT, 25 / 30

cycle at 0°

70% UT, 25 / 30

cycle at 0°

0% UT, 250 / 300

cycle

| 0% UT, 0.5 cycle at

0°, 45°, 90°, 135°,

180°, 225°, 270° and

315°

0% UT, 1 cycle at 0°

70% UT, 25 / 30

cycle at 0°

70% UT, 25 / 30

cycle at 0°

0% UT, 250 / 300

cycle

| HOME HEALTHCARE

environment

---|---|---|---
Power frequency (50/60 Hz) magnetic field

IEC 61000-4-8

| 30 A/m| 30 A/m| HOME HEALTHCARE

environment

Conducted RF IEC 61000-4-6| 3 Vrms

0.15 MHz to 80MHz 6 Vrms in ISM bands between 0.15 MHz and 80MHz

6 Vrms in amateur radio bands between 0.15 MHz and 80MHz

| 3 Vrms

0.15 MHz to 80MHz 6 Vrms in ISM bands between 0.15 MHz and 80MHz

6 Vrms in amateur radio bands between

0.15 MHz and 80MHz

| HOME HEALTHCARE

environment

Radiated RF IEC 61000-4-3| 3 Vrms

80 MHz to 2.7GHz 80% AM at 1KHz

| 3 Vrms

80 MHz to 2.7GHz 80% AM at 1KHz

| HOME HEALTHCARE

environment

Proximity magnetic fields IEC 61000-4-39| 30 kHz7 / CW /

8A/m

134.2 kHz / Pulse modulation8 2.1KHz

/ 65A/m9 13.56MHz / Pulse

modulation8 50 kHz

/ 7.5A/m9

| 30 kHz / CW / 8A/m

134.2 kHz / Pulse modulation 2.1KHz / 65A/m

13.56MHz / Pulse modulation 50 kHz / 7.5A/m

| HOME HEALTHCARE

environment

NOTE

1.     UT is the a.c. mains voltage prior to application of the test level ; 25 / 30 and 250 / 300 cycle means 25 / 250 for 50 Hz system and 30 / 300 for 60Hz system.

2.     The ISM (industrial, scientific and medical) bands between 0,15 MHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. The amateur radio bands between 0,15 MHz and 80 MHz are 1,8 MHz to 2,0 MHz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3 MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 MHz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,4 MHz, 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.

3.     Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot, theoretically, be predicted with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, consider conducting an electromagnetic site survey. If the measured field strength in the location the system is used exceeds the applicable RF compliance level listed in this table, observe the system to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the system.

4.     At 80 MHz and 800 MHz, the higher frequency range applies.

5.     These guidelines may not apply in all situations. Electromagnetic propagation is affected by the reflection from structures, objects, and people.
6. Portable and mobile RF communications equipment should be used no closer to any part of the device, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

Test frequency (MHz)| Band a)

(MHz)

| Service a)| Modulation b)| IMMUNITY TEST LEVEL

(V/m)

---|---|---|---|---

385

|

380-390

|

TETRA 400

|

Pulse modulation b) 18Hz

|

27

450

|

430-470

| GMRS 460,

FRS 460

| FM c)

±5 kHz deviation

1 kHz sine

|

28

710|

704-787

|

LTE Band 13,17

| Pulse modulation b) 217Hz|

9

745
780
810|

800-960

| GSM 800/900, TETRA 800,

iDEN 820,

CDMA 850,

LTE Band 5

|

Pulse modulation b) 18Hz

|

28

870

930

1 720|

1 700-1

900

| GSM 1800;

CDMA 1900;

GSM 1900; DECT;

LTE Band 1, 3, 4, 25; UMTS

|

Pulse modulation b) 217Hz

|

28

1 845

1 970

2 450

|

2 400-2

570

|

Bluetooth, WLAN,

802.11 b/g/n, RFID 2450, LTE Band 7

|

Pulse modulation b) 217Hz

|

28

5 240| 5 100-5

800

|

WLAN 802.11a/n

| Pulse modulation b) 217Hz|

9

5 500
5 785

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

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

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 measures below:

• 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.

Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. “Harmful interference” is defined in 47 CFR §2.1 by the FCC as follows: Interference which endangers the functioning of a radio navigation service or of other safety services or seriously degrades, obstructs, or repeatedly interrupts a radio communication service operating in accordance with the [ITU] Radio Regulations. This device has been evaluated and shown compliant with the FCC portable RF Exposure limits set forth for an uncontrolled environment. This transmitter must not be co-located or operated in conjunction with any other antenna or transmitter used in other systems.

Symbols used and Description

Manufacturer Information

Shenzhen Kaiyan Medical Equipment Co., Ltd Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China

FCC Statement

FCC Statement 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 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

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

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