Taian Dalu Medical Instrument DL-DF01 Electronic Peak Flow Meter Instruction Manual

Taian Dalu Medical Instrument DL-DF01 Electronic Peak Flow Meter

Instruction For Use

• Please read this manual carefully and follow the instructions before you use.
• Please keep this manual properly so that you can refer to it when you need it in the future.
• We recommend user to use the product exclusively and avoid sharing with others.

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.
This device complies with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.

CONVENTIONS USED IN THIS MANUAL

• Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
• Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.
• Indicates an operating tip, a maintenance suggestion, or a hazard that may result in device damage

Overview

Working principle:
The device is an impeller type flowmeter. When the gas flows through the pipe of the flowmeter, a spiral airflow is generated, which pushes the blades to rotate. During this period, the light beam emitted by the infrared generator will be interrupted by the rotating blade. The pulse signal formed by each interruption will be converted into an electrical signal, and be output and transmitted to the microprocessor. The number of revolutions can therefore be calculated, and the gas flow and volume can also be calculated based on it.

Function introduction:
The electronic peak flow meter is a portable device that can perform lung function tests. It can be used to measure the maximum expiratory flow rate (PEF). The maximum expiratory flow rate (PEF) refers to the highest flow rate during forced exhalation, also known as the highest expiratory flow rate, the maximum expiratory flow rate, and the best expiratory flow rate. PEF can better reflect the patency of the airway, help diagnose and evaluate asthma, and diagnose and classify the degree of airway obstruction.\

Intended use:
This device is intended for monitoring PEF (Peak Expiratory Flow Rate) for patient home use. The device is designed for adults and children over 5 years of age with caregiver supervision.

Contraindications:
There are no known Contraindications.

Safety Precautions

• Please stop using this meter immediately if it is damaged. Do Not touch any internal parts to avoid electric shock.
• n order to avoid electric shock or detector failure, do not allow any liquid to permeate into the meter.
• Do Not use the meter in the presence of flammable materials, solutions or gases, or in an oxygen enriched environment.
• Any unauthorized personnel should not tamper with the device.
• Only original accessories as specified by the manufacturer can be used with the device.
• In the event of an accident of any kind arising from use of the device, you are strongly recommended to inform the manufacturer or your doctor so that he/she can notify the authorities as required by local legislation.
• Any Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
• This equipment should be installed and operated with a minimum distance of 0mm between the radiator and your extremity,60mm for your head.
• The patient is an intended operator. The patient can use and maintain the meter and its accessories according to this manual.
• Put the meter into the specified storage case during transportation.
• Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts.
• The supervision of an adult is required for monitoring elderly subjects, children over the age of five and disabled persons.
• Periodically check that no impurities or foreign bodies, such as skin, hairs have deposited inside the turbine. This may cause errors in measurement or compromise the correct functioning of the device.
• The device is not designed to be used in direct air currents (e.g. wind), sources of heat or cold, direct sun rays or other sources of light or energy, dust, sand or chemical substances.
• Use and store the device in compliance with the environmental conditions specified in the Technical Specifications. If the device is subjected to environmental conditions other than those specified, it may malfunction and/or display incorrect results.
• At least 30min required for ME equipment to warm from the minimum storage temperature to the measuring environment temperature until it is ready for intended use.
• At least 30min required for ME equipment to cool from the maximum storage temperature to the measuring environment temperature until it is ready for intended use.

Product composition

Electronic Peak Flow Meter consists of main unit, turbine and blowing mouthpiece. Product structure diagram is shown below.

Materials of components is shown below.

Polycarbonate+Acrylonitrile Butadiene Styrene (PC+ABS)
Blowing mouthpiece| Polypropylene (PP)

Meaning of display icon in the screen is shown below.

 | Two-line displays the number

l  Setting phase：the first line does not display, the second line displays weight, age, height, time (year, month, day, hour,

minute)

l  Testing phase：the first line shows the PEF value, the second line

shows the PEF%

---|---
 | History record icon
| Sound Icon
| Battery icon
 | Blowing preparation prompt
 | PEF Value
 | Male icon
---|---
 | Female icon
 | Weight icon
 | Height icon
 | Indicator to traffic colour outside surface of main unit, the position of arrow means the degree of PEF normal or declined.
 | Kilogram (kg) icon
 | PEF%
Age| Age icon
Set| Setting icon

How to use

Installation

• Open the battery cover and insert two AAA batteries into the battery compartment.

• Install the turbine into the main unit, clamp the groove of the turbine to the slot in the main unit, and tighten it to the right according to the direction shown in the figure on the right.

• Insert the mouthpiece into the turbine according to the direction of arrow marked on the mouthpiece, and press it gently to ensure that there is no air leakage at the connection.

• Remove the accessories and batteries：remove in reverse order.
  NOTICE:

• Install the batteries correctly according to the sign of positive and negative terminals in the battery compartment.

Boot

• Long press the “ON/OFF” button for 2 seconds until you hear the “DI” sound, prompting the device has been turned on.
• When using for the first time, the screen interface displays the “SET”. Follow the interface prompts to enter age, gender, height, weight and other information in sequence, and then follow the interface prompts to set the year, month, date, hour, and minute in sequence.
• hort press the “ON/OFF” button to adjust the setting item, and short press “RIGHT” or “LEFT” button can increase or decrease the number.
• After the setting of basic information is completed, click the “ON/OFF” button. You can see the “ ” icon is flashing, and when you hear the continuous “DIDIDI” sound, indicating that the device is preparation for measurement. You can Long press the “LEFT” button for 2 seconds to reset the basic information.

Prompt:

1. After the setting of basic information is completed, the device will calculate an estimated value based on your input parameters, which is used to calculate PEF%.
2. The predicted value is not displayed, but PEF% will be displayed after

Testing

• Deeply inhale and use your lips to wrap the mouthpiece firmly, and make sure that there is no air leakage between the mouth and the mouthpiece. At the same time, you exhale the gas forcefully in the shortest time (one second or more).
• When you hear the “DI” sound, it indicates that the test has been completed. The screen interface displays the PEF test value and its percentage of the predicted value. The icon “ ” displayed on the right can indicate the area (green, yellow or red) that represents the test result.

NOTICE:

• Green area: indicates that your PEF is above 80% of the predicted value and is within the normal range, which means that your condition is under control. Please follow the doctor’s recommendation to decide whether you require the medication or do not require a higher dose of medication.
• Yellow area: indicates that your PEF is in the range of 60-80% of the predicted value, which means that you must pay attention to it. Please follow the doctor’s recommendation to take appropriate treatment measures, such as increasing the dose of medication.
• Red area: indicates that your PEF is below 60% of the predicted value, which means that your situation is dangerous. Please follow the doctor’s recommendation to take appropriate treatment measures, such as increasing the dose of medication or seeking emergency treatment.
• Please clean mouthpiece according to the Manual Chapter 4 to prevent from dust because of transport or storage when you use the device for the first time.
• o not block the air outlet with your tongue or teeth, otherwise the measurement result will be affected.
• Mouthoiece must be used by one person,don’t cross-use.

Remeasure

• Short press the “ON/OFF” button. When you hear the continuous “DIDIDI” sound, repeat step 3.3 to repeat the measurement testing.
• The device will automatically store the highest PEF value measured as the final measurement result. Performing the measurement testing 3 times is recommended. Doctors generally recommend taking one measurement in the morning and one in the evening every day.

History Record

• Click the “LEFT” or “RIGHT” button to check the corresponding history measurement record, and the corresponding history record number and test time will be displayed at the same time.
• After selecting the required history record number, the upper line displays the history record number, the lower line displays the corresponding test time (display in order: month, day, hour, minute). Waiting for about 2 seconds, the interface will automatically display the PEF value in the corresponding history record number (upper line) and PEF% (lower line).
  The device can store 500 sets of data. When the memory data exceeds 500 sets of data, the device will automatically overwrite the earlier data in the order of the memory data.

Data Transmission
The device can also be connected to communication devices (such as the phone) through Bluetooth.The patient’s PEF and PEFR data changes within one week can be monitored by APP, so that it is more convenient to monitor your respiratory health status.

Register and log in APP

• Open the APP and follow the prompts to register and log in to the APP.
• Fill in personal information on the APP, such as name, gender, age, height, weight and so on.

NOTICE:

• Please fill in your information truthfully, do not fill in false information.The APP will calculate your PEF% according to the information you fill in, and the measurement results will guide doctors to use medicine.

Intelligent detection

1. n the initial interface of the APP, select the Bluetooth symbol ” ” in the upper right corner to enter the Bluetooth connection interface.
2. Click “Bond” and then “This APP needs to use Bluetooth” going to pop up.Click “Allow”,the APP will search automatically. When “Connected to: JDY-08″ is displayed, the connection is successful.Bluetooth symbol ” “will then appear on the screen of the device.
3. The test can be performed according to 3.3 test steps for measurement, and the measured values will be uploaded to the APP synchronously.
4. Click “Got it” to enter the test interface.
5. Repeat the measurements as per steps 1-4.
   NOTICE

• The measurement should be taken three times in the morning and three in the afternoon. If the measurement is less than three times, the symbol “ ”on test interface is red, prompting you to continue to complete the measurement.After the measurement has been completed for three times, it turns blue to indicate that the measurement has been completed.

Report

• Click ” ” in the test interface and select “Data Report” to view the data graph of PEF value and PEFR within a week.
• Click ” ” in the test interface and select “Personal information” to modify your name, gender, age, height, weight, etc.

Shutdown

• Manual shutdown: long press the “ON/OFF” button for 2 seconds until you hear the “DIDI” sound and the screen interface displays “OFF” flashing twice, and the device will shut down.
• Automatic shutdown：If there is no any operation for 3 minutes in the standby state of the device, you will hear the “DIDI” sound and the screen interface will display “OFF” flashing twice, the device will automatically shut down.

Cleaning and disinfection

Cleaning of the turbine
NOTICE:

• Do not immerse the turbine in hot or boiling water.
• To avoid irreparable damage to the turbine, never try to clean the turbine under a direct jet of water or other liquids.

Correct operation of the turbine is guaranteed only if it is “clean” and free of foreign objects that affect its movement. The presence of dust or foreign bodies (such as hairs, sputum etc.) could slow or block the moving parts of the turbine and make the result less accurate, or damage the turbine itself. After each use, check the cleanliness of the turbine. Weekly cleaning is recommended. To clean the turbine, remove it from the main unit and seperate it from the mouthpiece. Immerse the turbine in warmy soapy water and agitate the turbine for 2-3 minutes. Rinse in purified water and shake gently to remove any excess water. If the device is not visually clean, the user should either repeat the relevant previous cleaning steps untill it is clean.Then wipe it dry with a clean soft cloth or allow to air dry on a towel. Finally store it in a clean, ventilated, and dry place.

Cleaning and disinfection of the mouthpiece
Make sure to clean and disinfect the mouthpiece after each use. To clean the mouthpiece, simply pull it apart from the turbine. Immerse the mouthpiece in warmy soapy water and agitate the mouthpiece for 2-3 minutes. Rinse in purified water and shake gently to remove any excess water. If the device is not visually clean, the user should either repeat the relevant previous cleaning steps untill it is clean.Then wipe it dry with a clean soft cloth. To disinfect the mouthpiece, wipe the clean mouthpiece with an alcohol cotton pad or a cotton cloth moistened with 75% alcohol for 2 miniutes. Allow to air dry on a towel. Finally store it in a clean, ventilated and dry place.

Cleaning of the main unit
Weekly cleaning is recommended. To clean, wipe the device’s surfaces with a soft damp cloth. Dry with a soft cloth, or allow to air dry. Ensure that all surfaces are completely dry. Finally store it in a clean, ventilated, and dry place.
NOTICE:

• Do not clean the main unit in water or other liquids.

Maintenance

Battery
When the battery is too low, the “  ” ” symbol will flash 2 times, and the “OFF”  will flash 2 times immediately accompanied by “DIDI” sound. The device will shut down at this time, and you should replace the battery with a new one in time.
NOTICE：

• Please take out batteries from battery case to avoid battery leakage if you do not use the device for a long time.
• Please select batteries with regular factory instead of fake and shoddy batteries
• If the battery volume is not sufficient, the accuracy of parameter of PEF may be affected

Repair
The repair of the device is limited to qualified maintenance personnel designated by the manufacturer. Users are not allowed to disassemble and repair it. If necessary, the relevant technical documents such as circuit diagrams and component lists required for maintenance can be provided.
Important:
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.

Storage
Please store the electronic peak flow meter in a clean and dry place under the storage environment condition as specified in the manual. Do not place it under the sun or extreme high or low temperature to avoid severe impact. Otherwise, these may cause the device to fail to work normally or even be damaged.

Waste disposal
The meter, accessories and consumables are to be disposed of according to local law or regulation after they have exceeded their service life. Alternatively, they can be returned to the local distributor or the manufacturer for recycling or proper disposal. For the detailed disposal information, consult the manufacturer or the local distributor.

Common troubleshooting

Abnormal

phenomenon

| Possible reason| Resolution method
---|---|---

Screen             shows nothing

| ****

The battery level is too low or the battery is installed incorrectly.

| Replace the battery with a new one and pay attention to the direction in which the positive and negative

electrodes are installed.

Screen shows “Err 1”

| ****

1.    No blowing in 30 seconds

2.    System failure

| 1.    Follow operation step 3.3 again to perform the testing

2.    System failure, please

contact the manufacturer or dealer

Screen shows “Err 2”

| Out of measurement range (PEF Value ＜

50L/min)

| Follow    operation    step   3.3 again to perform the testing

Screen shows “Err 3”

| Out of measurement range (PEF Value ＞

999L/min)

| Remeasure or replace other equipment to measure
---|---|---
The display suddenly

disappears.

| The battery is loose.| Reinstall the battery

NOTICE:

• If you take the above measures, the electronic peak flow meter still can not be used normally, it is recommended to contact the manufacturer or dealer.

Product features

Classified by the degree of protection

against electric shock

| Type BF application part
Degree of IP protection| IP22
Classification of safety levels when used in the presence of flammable anesthetic gases mixed with flammable anesthetic

gases or nitrous oxide mixed with air

| Non-AP/APG Device
Classified by operating mode| Continuous
Classification of sterilization method| Non-Sterile Medical Device

Technical Specifications

Operating    environment condition

| ****

Ambient temperature range: 5℃～40℃ Relative humidity range: 15～90%RH Atmospheric pressure range: 70KPa～106KPa

Storage/transport environment condition

| Ambient temperature range: -25℃～55℃ Relative humidity range: 15～93%RH

Atmospheric pressure range: 86KPa ～ 106KPa

（under uncondensed state）

Symbol used in labeling

Type BF applied part

| Batch code
| Refer to instruction manual/ booklet
****| Caution

| This symbol indicates that waste electrical and electronic equipment must not be disposed of as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the

decommissioning of your equipment.

---|---
IP22| Degree of IP protection
| Temperature limitation
| Humidity limitation
| Atmospheric pressure limitation
****| RF

Guidance and manufacturer´s declaration

Electronic Peak Flow Meter complies with IEC 60601-1-2:2020 on electromagnetic compatibility (EMC for medical devices) for both immunity and emissions.

Electromagnetic emission

2

| The model DL-DF01 is intended for use in the electromagnetic environment specified below. The customer or the user of the model DL-DF01 should assure that it is used in such an environment.
3| Emissions

test

| Compliance| Electromagnetic environment – guidance

4

| RF emissions

CISPR 11

| ****

Group 1

| The Model DL-DF01 uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference

in nearby electronic equipment.

5| RF emissions

CISPR 11

| ****

Class B

| The Model DL-DF01 is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

6

| Harmonic emissions| ****

Not applicable

 | IEC 61000-3-2|  |
---|---|---|---

7

| ****

Voltage fluctuations / flicker emissions

IEC 61000-3-3

| ****

Not applicable

NOTICE:
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.
Electromagnetic immunity

Guidance and manufacturer´s declaration – electromagnetic immunity

The Model DL-DF01 are intended for use in the electromagnetic environment specified below.

The customer or the user of the Model DL-DF01 should assure that it is used in such an environment.

Immunity test| IEC 60601

test level

| ****

Compliance level

| Electromagnetic environment –

guidance

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

| Floors should be wood, concrete or

ceramic tile. If floors are covered with synthetic material, the relative humidity

should be at least 30 %.

Electrostatic transient / burst

IEC 61000-4-4

| ± 2 kV for power supply lines

100 kHz repetition frequency

± 1 kV for input/output lines

| ****

N/A

| ****

N/A

Surge

IEC 61000-4-5

| ****

± 0.5 kV, ± 1 kV

differential mode line-line

| ****

N/A

| ****

N/A

Voltage dips, short| 0 % UT

(100 % dip in UT )

| N/A| N/A
interruptions| for 0.5 cycle at 0°,|  |
---|---|---|---
and

voltage

variations on power

| 45°, 90°,

135°,180°, 225°,

270°, and 315°

supply

input lines

| 0 % UT

(100 % dip in UT)

IEC| for 1 cycle at 0°
61000-4-11| 70 % UT
 | (30 % dip in UT)
 | for 25/30 cycles at
 | 0°
 | 0 % UT
 | (100 % dip in UT)
 | for 250/300 cycle at
 | 0°
Power frequency (50/60 Hz)

magnetic field

IEC 61000-4-8

| ****

30 A/m, 50/60Hz

| ****

30 A/m, 50/60Hz

| Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.
NOTE: UT is the a. c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic immunity

The DL-DF01 is intended for use in the electromagnetic environment specified

below. The customer or the user of the DL-DF01 should assure that it is used in such an environment.

Immunity

test

| IEC 60601

test level

| Compliance

level

| Electromagnetic environment –

guidance

Conducted

| ****

3 Vrms

| ****

N/A

| Portable and mobile RF communications           equipment should be used no closer to any part of the Models DL-DF01, including cables, than the recommended              separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

d = é3.5ù  P

ê V ú

ë   1  û

d = é3.5ù  P 80MHz to 800MHz

ê E ú

ë   1  û

d = é 7 ù  P 800MHz to 2.7GHz

ê E ú

ë   1 û

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres(m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey,a should be less than the compliance level in each frequency range b

Interference may occur in the

---|---|---|---
RF| 150 kHz to|
 | 80 MHz|
IEC| 6 Vrms150|
61000-4-6| kHz to 80|
 | MHz outside|
 | ISM bandsa|
 |  | ****

10 V/m

Radiated RF|  |
 | 10 V/m|
IEC|  |
61000-4-3| 80 MHz to|
 | 2.7 GHz|
 |  |  | vicinity of equipment marked with the following 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 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.
• b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,7 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 has been incorporated into the formulae used in calculating the recommended separation distance for transmitters in these frequency ranges. c Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the DL-DF01 is used exceeds the applicable RF compliance level above, the DL-DF01 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the DL-DF01. d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Recommended separation distances

Recommended separation distances between portable and mobile RF communications equipment and the model
The Model DL-DF01is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Model DL-DF01 can help prevent electromagnetic interference by

maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Model DL-DF01 as recommended below, according to the maximum output power of the

communications equipment.

Rated maximum output of transmitter

W

| Separation distance according to frequency of transmitter m
150 kHz to 80 MHz

d = [3.5] P V 1

| 80 MHz to 800 MHz

d = [3.5] P E 1

| 800 MHz to 2.7 GHz

d = [ 7 ] P E 1

0.01| 0.12| 0.04| 0.07
0.1| 0.37| 0.12| 0.23
1| 1.17| 0.35| 0.7
10| 3.7| 1.11| 2.22
100| 11.7| 3.5| 7.0
For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) 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.

• Do not use the meter near other devices (computers, cordless phones, cell phones, etc.) that generate strong magnetic fields. Keep these devices at a minimum distance of 30 centimeters. If it is necessary to use it at shorter distances, the meter and the other devices must be kept under observation to verify that they work normally.
• Due to the increasing number of electronic devices (computers, cordless phones, cell phones, etc.) medical devices may be susceptible to electromagnetic interference from other equipment. Such electromagnetic interference could cause the medical device to malfunction, as a measurement accuracy lower than stated, and create a potentially unsafe situation.
• The use of accessories other than those specified, may result in increased emissions or decreased immunity of the equipment or system
• To maintain compliance with the RF exposure requirement, a separation distance of 20 cm between the device and the human should be maintained.

Information of Manufacturer

Name: Taian Dalu Medical Instrument Co., Ltd. Address: West Part of Yitianmen Street, Hi-tech Zone, Taian 271000, Shandong, P.R.China Tel: +86 538-8931968 Fax: +86 538-8931969

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