Contents

Introduction -------------------------------------------------------1

1 Product introduction -------------------------------------------1

2 European authorized representative -------------------------6

3 Standard icons --------------------------------------------------6

4 Contraindications ----------------------------------------------7

5 Installation and disassembly method of accessories ------7

6 Operation method ----------------------------------------------9

7 Charging instruction -------------------------------------------9

8 Safety precautions ---------------------------------------------9

9 Cleaning, Disinfection, Sterilization and Maintenance 10

10 Troubleshooting -------------------------------------------- 16

11 After-sales service ------------------------------------------ 17

12 Environment protection ----------------------------------- 17

13 EMC-Declaration of comformity ------------------------ 17

14 Statement ---------------------------------------------------- 21

Introduction

Thank you for purchase Fi-P Heating and Packing Instrument

developed by Guilin Woodpecker Medical Instrument Co., Ltd, a Hi-tech

enterprise developing, manufacturing, and selling dental instruments.

Woodpecker has excellent Quality Control System. To guarantee correct

and safe operation, please read this Instruction Manual carefully before

use.Depending on the level of risk involved, safety requirements are

classed under the following indications:

Danger: (always referred to personal injury)

Warning: (referred to possible damage to property)

1 Product introduction

1.1 Intended use

It is used to provide heat to the Work Tip, cut the gutta-percha point,

and soften and pressurize the gutta-percha. And the applied part is Work

Tip.

1.2 Diagram of components and control buttons

1. “ON/OFF” button 2. Heating button

3. Work Tip Protector 4. Work Tip

5. Connecting hole for power adapter 6. Temperature Level

7. Battery level 8. Charging base

9. Battery cartridge 10. Charging indicator

11. Power adapter plug 12. Power adapter unit

)

“ON/OFF” button:

Under shutdown state, shortly press “ON/OFF” button to start the

device.

Under shutdown state, long press “ON/OFF” button to start the device

and change the direction of screen display, that is to say, the direction of

display can be change to adapt to the operation in left hand or right hand.

Under ON state, long press “ON/OFF” button to shut down the device.

(Time for long press is about 1s.)

Note: If there is no operation for 10 minutes, the Heating and Packing

Instrument will automatically shut down.

Under ON state, shortly press “ON/OFF” button to change the preset

temperature of Work Tip. The preset temperature will change to the next

with the sequence 150℃→180℃→200℃→230℃ after each press. And

then go back to 150℃ after short press at temperature of 230℃.

150 180 200 230

Figure 1 Preset temperature

2) Heating button:

Under the ON state, connect the Work Tip, and press Heating button to

start heating. Release the Heating button to stop heating, followed by the

fall of Work Tip temperature.

Note: If press and hold the Heating button for more than 10 seconds,

the device will stop heating. If need to continue heating, please release

the Heating button and press again.

3) Volume set

After power-on ,press “ON/OFF” button and “Heating” button

simultaneously to enter the voice volume setting mode, then short press

the “ON/OFF” button to select suitable voice volume, the last, short press

the “Heating” button to exit the voice volume setting mode as shown in

Figure2.

4) Battery level:

The actual power of the battery is displayed in real time on the screen.

When the battery is fully charged, the power of the OLED display is

displayed as ve grids. When the battery level is one grid, it indicates that

the battery is low and needs to be charged in time. When the battery level

is displayed as a space, it indicates that the battery is very low and needs

to be charged immediately.

Note: During normal use, try not to let the battery level reduced to

space status (completely no power) before charge, which will shorten the

service life of battery.

Warning:

If the device has not been used for more than one month, the battery

needs to be recharged. If the device is not in use for a long time, please be

sure to charge it at least once a month to protect the battery. The service

life of battery of Heating and Packing Instrument will be shortened when

it is in a low battery state for a long time or when it leaves the charging

base for a long time.

5) Temperature Level:

When the temperature is preset, the display screen shows the preset

temperature value. About 1s after the temperature preset, the OLED

screen will display the real-time temperature of the Work Tip. When the

Heating and Packing Instrument is in the heating state, the temperature

indicator will simultaneously display the current temperature of the Work

Tip.

6) Charging base:

Firstly, connect the power adapter plug to the power adapter as shown

in Figure 3. Then connect the power adapter to the power connecting hole

on the charging base as shown in Figure 4 and connect the power adapter

to a standard socket. Place the Heating and Packing Instrument correctly

on the charging base as shown in Figure 5, so that the charging connector

under the Heating and Packing Instrument can be reliably connected to

the output connector of the charging base. When the Heating and Packing

Instrument is properly connected to the charging base, the LED charging

indicator on the base will be on constantly. If the LED is ashing or not

lit, please check all the cables carefully.

There are charging status indicators on the charging base. When the

Heating and Packing Instrument is not placed on the charging base, the

indicator will ashes in yellow and green alternately. When the Heating

and Packing Instrument is placed on the charging base, if the charging

is being charged, the yellow indicator will be on constantly. When the

battery is full, the yellow indicator will be o and the green indicator will

be on constantly.

Notes: After receiving the device, please charge it immediately.

Before use, please be sure that battery is fully charged. When the device

is fully charged, the battery level of the Heating and Packing Instrument

led display screen is the highest. After the battery runs out, the time of

battery charging takes at least 2 hours and 30 minutes.

Figure 3 Installation of power adapter Figure 4 Connection to power supply

Figure 5 Charging

1.3 Device includes

1. Heating and Packing Instrument

Charging base

3. Power adapter with cord

4. Work Tips (The models are as shown in Table 2)

5. Work Tip Protector

6. Instruction Manual

7. Qualied Certication

8. Warranty card

9. Packing list

Model Work Tip

Size(mm)

Taper

WP4004 0.40 0.04

WP4504 0.45 0.04

WP5506 0.55 0.06

WP5508 0.55 0.08

Table 2 Model of Work Tips

1.4 Introduction and scope of application

1.4.1 Features:

a) The display can be set to both right and left sides, to meet the needs

of both left-hander and right-hander.

b) Cordless design for Heating and Packing Instrument effectively

broadens the operation space.

c) Sensitive temperature control, simple display, and convenient

operation; Press temperature setting button to set suitable working

temperature.

d) Four preset temperatures are for option: 150℃, 180℃, 200℃,

230℃

e) If there is no operation for 10 minutes, the Heating and Packing

Instrument will automatically shut down.

1.4.2 Scope of application:

Used in the root canal obturation stage in endodontic treatment.

1.5 Product specications

Size

Heating and Packing Instrument 23.8mm×158.3mm×23.8mm

Charging base 75.5mm×149.7mm×62.6mm

Weight

Heating and Packing Instrument 80g

Charging base 195g

Power adapter 167g

1.6 Technical parameters

Classication Class Ⅱ(AC/DC power adapter)

Optional preset

temperatures

150℃→180℃→200℃→230℃

Time consumption for

charging

About 2.5h

Power supply

Input

AC100V-240V 50/60Hz

800mA

Output DC15V/1.6A

Battery capacity Chargeable battery 2000mAh

Heater Rating 10W

1.7 Environmental parameters

Temperature: +5℃ ~ +40℃

Humidity: 30% ~ 75%

Air pressure: 70kPa ~ 106kPa

1.8 Storage and transport

1. The device should be handled carefully and lightly. Be sure that

it is far from the vibration, and is installed or kept in a cool, dry, and

ventilated place.

2. Do not store the device together with the articles that are

combustible poisonous, caustic, or explosive.

3. The device should be stored in a room where the relative humidity

is 10% ~ 93%, the air pressure is 70kPa ~ 106kP, and the temperature is

-20℃ ~ +55℃.

4. Please avoid the device from strong shock or vibration during

transport. And please handle it carefully.

5. Please do not mix the device with hazardous articles during

transport.

6. Please avoid the device from sun, rain, and snow during transport.

2 European authorized representative

3 Standard icons

Product serial number

Follow Instructions for Use

Manufacturer Date of manufacture

Type B applied part Class II device

Power switch Ordinary equipment

Used indoor only Caution,hot surface

Can be autoclaved DC 15V

CE marked product

Device complies with WEEE directive

Attention! Please refer to the accompanying documents.

Humidity limit for storage: 10% ~ 93%

Atmospheric pressure for storage: 70kPa ~ 106kPa

Temperature limit for storage: -20℃ ~ +55℃

Authorised Representative in the EUROPEAN

COMMUNITY

4 Contraindications

1. People who are allergic to known natural latex and metals such as

stainless steel, silver, copper, etc. are forbidden to use this device.

2. The patient with hemophilia is forbidden to use this device.

3. The patients with heart pacemaker are forbidden to use this device.

4. The dentists with heart pacemaker are forbidden to use this device.

5. Heart disease patients, pregnant women and children should be

cautious to use the equipment.

5 Installation and disassembly method of

accessories

5.1 Connection of power adapter

Connect the output point of power adapter to the charging base, and

connect the input point to the socket that meets the standard of this

power adapter. Please install in accordance with the procedures in Figure

3, Figure 4, and Figure 5. (Note: The installation in Figure 3 had been

nished before delivery.)

5.2 Installation and removal of Work Tip

1. After turning o the power switch, you can directly pull the Work

Tip o the Heating and Packing Instrument.

2. Place the used Work Tip in a certain container and disinfect it.

3. Select the desired work Work Tip and the hexagonal plug on the

Work Tip (as indicated by the red arrow in Figure 6). When installing

the work Work Tip as shown in Figure 7, you can select the appropriate

direction according to the usage to insert the Work Tip into the Heating

and Packing Instrument.

4. Install the Work Work Tip Protector to the Work Tip as shown in

Figure 8, to prevent scalding patient’s mouth during operation.

5. Under ON state, if the Work Tip hasn’t been installed or is in poor

connection, there would be an error code on display screen as shown in

Figure 9.

Figure 6 Work Tip Figure 7 Installation of Work Tip

open

Figure 8 Installation of

Work Tip Protector Figure 9 Error code

5.3 Installation and replacement of battery

When replacing the battery, as shown in Figure 10, first rotate the

battery barrel counterclockwise to remove the battery tube, then take the

old battery out of the battery tube, replace it with a new one, and nally

tighten the battery tube clockwise according to the corresponding thread.

Warning: When removing the battery, the screw under the

battery barrel (pointed by the arrow in Figure 10) does not need to be

unscrewed,just push the connector slightly inward to remove the battery.

Improper replacement of lithium batteries may result in unacceptable

risks,so replacement of lithium batteries requires trained personnel.

Figure 10 Replacement of battery

6 Operation method

1. According to the situation of patient, select suitable Work Tip and

install it. When installing the Work Tip, chose a suitable angle to install

the Work Tip.

Danger:

Don’t turn on the device when installing the Work Tip, to prevent

scalding the user by mistakenly pressing the heating button.

2. After pressing the “ON/OFF” button, the display screen of Heating

and Packing Instrument lights up and display the preheating temperature

and power status.

3. According to the actual situation, lightly press the temperature

setting button, and select suitable preheating temperature as per the

instruction on display screen.

4. During operation, lightly press the heating button so as to heat up

to the preset temperature, soften and pressurizing the gutta-percha with

careful, continuous and stable motion with the help of vertical pressurizer.

Note: The continuous heating time on gutta-percha cannot exceed 4s,

or there would be risk of scalding.

5. After operation, please clean, disinfect, and sterilize the Work Tip.

The specic method is shown in Chapter 9.

7 Charging instruction

7.1 Use the corresponding charging base for this device. Connect the

power adapter with the charging base, connect the power supply, and

then correctly place the Heating and Packing Instrument into the charging

base.

7.2 The battery used in this product has no memory and can be used at

any time or charged at any time.

7.3 Before rst use of this device, please charge it at least for 3 hours.

Warning: Only unplug the adapter to disconnect from the

network power.

8 Safety precautions

1. Do not polish the Work Tip.

2. Do not knock or scratch the Heating and Packing Instrument.

3. Keep the heating pressurizer, Work Tip, etc. under heating state

away from inammable and explosive materials.

4. Please keep the device clean before and after operation. Before each

use, please disinfect Work Tip and its accessories.

5. The product should be in strict accordance with relevant operation

specications of medical authority and relative regulations. The product

can only be operated by trained doctors or technicians.

6. Do not install, remove, or replace the Work Tip under heating state.

Please power o before replace the Work Tip.

7. The Work Tip must be correctly installed to prevent it from falling

o.

8. When the Work Tip is bent or worn, it will cause uneven heating.

The operator should replace the Work Tip in time according to the clinical

conditions;

9. After operation, please turn o the power immediately.

Woodpecker is specialized in producing medical instrument. We are

only responsible for the safety on the following conditions:

a) The maintenance, repair, and modification are made by the

manufacturer or the authorized dealers.

b) The charged components are original of “Woodpecker” and

operated according to instruction manual.

9 Cleaning, Disinfection, Sterilization and

Maintenance

The cleaning, disinfection and sterilization of Work Tip. Unless

otherwise stated, it will be hereinafter referred to as “product”.

Warnings

The use of strong detergent and disinfectant (alkaline pH>9 or acid

pH <5) will reduce the life span of product. And in such cases, the

manufacturer takes no responsibility. This product shall not be exposed to

high temperature above 138℃.

9.1 Processing limit

The product have been designed for a large number of sterilization

cycles. The materials used in manufacture were selected accordingly.

However with every renewed preparation for use, thermal and chemical

stresses will result in ageing of the product. The maximum number of

sterilizations for Work Tip is 100 times.And each time you carry out

Cleaning

；

disinfection and sterilization, you must make corresponding

records. And each time you carry out cleaning and disinfection, you must

make corresponding records

9.2 Initial processing

9.2.1 Processing principles

It is only possible to carry out effective sterilization after the

completion of eective cleaning and disinfection. Please ensure that, as

part of your responsibility for the sterility of products during use, only

sufficiently validated equipment and product-specific procedures are

used for cleaning/disinfection and sterilization, and that the validated

parameters are adhered to during every cycle. Please also observe the

applicable legal requirements in your country as well as the hygiene

regulations of the hospital or clinic, especially with regard to the

additional requirements for the inactivation of prions.

9.2.2 Post-operative treatment

The post-operative treatment must be carried out immediately, no later

than 30 minutes after the completion of the operation. The steps are as

follows:

1. Turn o the Heating Handpiece and allow it to stand on the base for

1 minutes to cool down to room temperature at the Work Tip;

2. Use a cotton swab or a clean soft cloth to remove the remaining

Gutta-percha material from the Work Tip,

3. Dry the product with a clean, soft cloth and place it in a clean tray.

9.2.3 Preparation before cleaning

Steps

Tools: tray, clean and dry soft cloth.

1. Remove the Work Tip Protector from the handle and put it into a

clean tray.

2. Remove the Work Tip from the handle and place it in a clean tray.

3. Wipe the Work Tip with a soft cloth until no dirt can be seen on the

surface. Then dry it with a clean soft cloth and put them into a clean tray.

Cleaning agent can be pure water.

Notes:

The pure water temperature should not exceed 45 °C, otherwise the

protein will solidify and it is dicult to remove.

9.3 Cleaning

The cleaning should be performed no later than 24 hours after the

operation.The cleaning adopt automated cleaning.

The cleaning procedure are as follows.

1) Pre-wash with pure water at 25 ° C for 3 minutes.

2) Clean with the condition recommended by the cleaning agent

manufacturer for 5 minutes. For example the detergent use RUHOF

ENDOZIME AW PLUS WITH APA,Dilution Ratio1: 270, temperature

25℃.Clean for 5minutes.

3) Rinse twice with pure water at 25 ° C for 1 minute each.

Notes:

a)The solution used the pure water and only freshly prepared solutions

can be used.

b)During the use of cleaner, the concentration and time provided by

manufacturer shall be obeyed.

c)The cleaner is proved to be valid by CE certicationin accordance

with EN ISO 15883.

d)The cleaning procedure is suitable for the product, and the irrigating

period is sucient.

9.4 Disinfection

Disinfection must be performed no later than 2 hours after the cleaning

phase. Automated disinfection is preferred if conditions permit.

For the thermal disinfection here, the temperature is 93 ° C, the time is

5 min, and A0>3000.

Cleaning and disinfecting steps by using Washer-disinfector

1. Carefully place the product into the disinfection basket. Fixation of

product is needed only when the product is removable in the device. The

product is not allowed to contact each other.

2. Start the program.

3. After the program is nished, remove the product from the washer-

disinfector, inspect (refer to section “Inspection and Maintenance”) and

packaging (refer to chapter “Packaging”). Dry the product repeatedly if

necessary (refer to section“Drying”).

The intrinsic suitability of the product for effective cleaning and

disinfection using the above automated cleaning and disinfection

procedures was veried by a certied facility.

Notes:

a) Before use the washer-disinfector, you must carefully read the

operating instructions provided by the equipment manufacturer to

familiarize yourself with the disinfection process and precautions.

b) With this equipment, cleaning, disinfection and drying will be

carried out together.

c) Only pure water with a small amount of microorganisms (<10 cfu/

ml) can be used for all rinsing steps. (For example, pure water that is

in accordance with the European Pharmacopoeia or the United States

Pharmacopoeia).

d) The air used for drying must be ltered by HEPA.

e) Regularly repair and inspect the disinfector.

9.5 Drying

If your cleaning and disinfection process does not have an automatic

drying function, dry it after cleaning and disinfection.

Methods

1) Spread a clean white paper (white cloth) on the at table, point the

product against the white paper (white cloth), and then dry the product

with filtered dry compressed air (maximum pressure 3 bar). Until no

liquid is sprayed onto the white paper (white cloth), the product drying is

completed.

2) It can also be dried directly in a medical drying cabinet (or oven).

The recommended drying temperature is 80℃~120℃ and the time

should be 15~40 minutes.

Notes:

a) The drying of product must be performed in a clean place.

b) The drying temperature should not exceed 138 °C;

c) The equipment used should be inspected and maintained regularly.

9.6 Inspection and maintenance

In this chapter, we only check the appearance of the product. After

inspection, ensure that there is no problem.

9.6.1 Check the product. If there is still visible stain on the product

after cleaning/ disinfection, the entire cleaning/disinfection process must

be repeated.

9.6.2 Check the product. If it is obviously damaged, smashed,

detached, corroded, it must be scrapped and not allowed to continue to be

used.

9.6.3 Check the product. If the accessory is found to be damaged,

please replace it before use. And the new accessory for replacement must

be cleaned, disinfected and dried.

9.6.4 If the number of times of the product reaches the specified

number of times, please replace it in time.

9.7 Packaging

Install the disinfected and dried product and quickly package it in a

medical sterilization bag (or special holder, sterile box).

Notes:

a) The package used conforms to ISO 11607;

b) It can withstand high temperature of 138 °C and has sucient steam

permeability;

c) The packaging environment and related tools must be cleaned

regularly to ensure cleanliness and prevent the introduction of

contaminants;

d) Avoid contact with parts of dierent metals when packaging.

9.8 Sterilization

Use only the following steam sterilization procedures (fractional pre-

vacuum procedure*) for sterilization, and other sterilization procedures

are not recommended:

1. The steam sterilizer complies with EN13060 or is certified

according to EN 285 to comply with EN ISO 17665;

2. The sterilization time is 5 minutes at a temperature of 134℃ and a

pressure of 2.0 bar ~ 2.3 bars.

Verication of the fundamental suitability of the products for eective

steam sterilization was provided by a veried testing laboratory.

Notes:

a) Only the product that have been eectively cleaned and disinfected

are allowed to be sterilized;

b) Before using the sterilizer for sterilization, read the Instruction

Manual provided by the equipment manufacturer and follow the

instructions.

c) Do not use hot air sterilization and radiation sterilization as this may

result in damage to the product;

d) Please use the recommended sterilization procedures for

sterilization. It is not recommended to sterilize with other sterilization

procedures such as ethylene oxide, formaldehyde and low temperature

plasma sterilization. The manufacturer assumes no responsibility for the

procedures that have not been recommended. If you use the sterilization

procedures that have not been recommended, please adhere to related

eective standards and verify the suitability and eectiveness.

* Fractional pre-vacuum procedure = steam sterilization with repetitive

pre--vacuum. The procedure used here is to perform steam sterilization

through three pre-vacuums.

9.9 Storage

9.9.1 Store in a clean, dry, ventilated, non-corrosive atmosphere with

a relative humidity of 10% to 93%, an atmospheric pressure of 70KPa to

106KPa, and a temperature of -20 °C to +55 °C;

9.9.2 After sterilization, the product should be packaged in a medical

sterilization bag or a clean sealing container, and stored in a special

storage cabinet. The storage time should not exceed 7 days. If it is

exceeded, it should be reprocessed before use.

Notes:

a) The storage environment should be clean and must be disinfected

regularly;

b) Product storage must be batched and marked and recorded.

9.10 Transportation

1. Prevent excessive shock and vibration during transportation, and

handle with care;

2. It should not be mixed with dangerous goods during transportation.

3. Avoid exposure to sun or rain or snow during transportation.

9.11 The cleaning and disinfection of main unit and charging base are as

follows.

Warnings: Do not clean the main unit and charging base with

ultrasound cleaning machine.

• Before each use, wipe the surface of the main unit and charging base

with a soft cloth or paper towel soaked in 75% medical alcohol. Repeat

the wipe for at least 3 times.

• After each use, wipe the surface of the main unit and charging base

with a soft cloth soaked in clean water (pure water) or a clean disposable

wipe. Repeat the wipe for at least 3 times.

9.12 Daily maintenance

1. When the device is not used, please turn o the power and unplug

the power supply plug.

2. If the Heating and Packing Instrument is in a low battery state for a

long time, the service life of battery will be shortened. Please charge it in

time if the battery level is low.

3. When the device is not used, please charge it for 1 hour once a

month.

9.13 Repair of device

This product does not contain self-repairing spare parts. If there

is any abnormality in the equipment, please contact our company

for maintenance and do not disassemble without authorization. With

our company's consent, we will provide circuit diagrams, component

part lists, descriptions, calibration instructions to assist to SERVICE

PERSONNEL in parts repair.

10 Troubleshooting

Fault Cause Solution

No indications,

no response

1. Inadequate battery power

2. Battery is damaged.

3. The charging interface is

short-circuited, causing the

lithium battery to enter a

protection state;

4. Heating and Packing

Instrument is damaged.

1. Connect to power

supply to charge. /

Replace the battery.

2. Replace the battery.

3. Remove the substance

that causes the short

circuit, put the device

into the charging base

to charge, and then the

device will return to

normal;

4. Contact local distributor

or manufacturer.

Automatic

shutdown

If there is no operation for

10 minutes, the device will

automatic powers o.

Reboot

Work Tip

works

abnormally

1. The Work Tip is damaged.

2. Malfunction of main unit

1. Replace the Work Tip

2. Send it to the repair

center.

Charging

failure after

connecting to

power supply

1. The power supply is not

correctly connected;

2. The power supply is

damaged, or the specication

doesn’t match.

3. There are impurities on the

contact thimble of charging

base.

1. Unplug and reconnect.

2. Replace the battery.

3. Wipe the thimble

with alcohol, dry it, and

reconnect.

The service

time after each

charging is

shortened

The battery ages and the

battery capacity become

smaller.

Contact local distributor

or manufacturer to

buy new batteries for

replacement.

OPEN code

appears on

display screen

1. The Work Tip is damaged.

2. The Work Tip is not

installed.

3. The Work Tip is not well

installed.

1. Replace the Work Tip.

2. Install the Work Tip.

3. Unplug the Work Tip,

and reconnect.

If the problem still cannot be solved, please contact your local dealer

or our company.

11 After-sales service

Since the date of sales, if the device cannot work normally for quality

problem, our company will be responsible for the repair of device during

the warranty period. Please refer to the Warranty Card for warranty

period and warranty scope.

12 Environment protection

The device does not contain any harmful ingredients. It can be handled

or destroyed in accordance with the relevant local regulations.

Note:

)

Without Woodpecker agreement and authorization, private

modification of device may result in the electromagnetic compatibility

problem of that device or other devices.

2) The design and test of Heating and Packing Instrument complies

with the related operation regulations of electromagnetic compatibility.

13 EMC-Declaration of comformity

The device has been tested and homologated in accordance with EN

60601-1-2 for EMC. This does not guarantee in any way that this device

will not be effected by electromagnetic interference Avoid using the

device in high electromagnetic environment.

Technical Description Concerning Electromagnetic Emission

Table 1: Declaration - electromagnetic emissions

Guidance and manufacturer’s declaration - electromagnetic emissions

The model Fi-P is intended for use in the electromagnetic environment specied

below. The customer or the user of the model Fi-P should assure that it is used

in such an environment.

Emissions test Compliance Electromagnetic environment -

guidance

RF emissions

CISPR 11

Group 1 The model Fi-P 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.

RF emissions

CISPR11

Class B The model Fi-P is suitable

for used 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.

Harmonic emissions

lEC 61000-3-2

Class A

Voltage uctuations /

icker emissions

lEC 61000-3-3

Complies

Technical Description Concerning Electromagnetic Immunity

Table 2: Guidance & Declaration - electromagnetic immunity

Guidance & Declaration — electromagnetic immunity

The model Fi-P is intended for use in the electromagnetic environment specied

below. The customer or the user of the model Fi-P should assure that It is used

in such an environment.

Immunity test IEC 60601

test level

Compliance level Electromagnetic

environment - guidance

Electrostatic

discharge (ESD)

lEC 61000-4-2

±8kV contact

±2, ±4, ±8,

±15kV air

±8kV contact

±2, ±4, ±8, ±15kV

air

Floors should be wood,

concrete or ceramic tile.

If oors are covered with

synthetic material, the

relative humidity should

be at least 30 %.

Electrical fast

transient/burst

IEC 61000-4-4

±2kV for power

supply lines

±1kV for Input/

output lines

±2kV for power

supply lines

Mains power quality

should be that of a

typical commercial or

hospital environment.

Surge

lEC 61000-4-5

±0.5, ±1kV line

to line

±0.5, ±1, ±2kV

line to earth

±0.5, ±1kV line to

line

±0.5, ±1, ±2kV

line to earth

Mains power quality

should be that of a

typical commercial or

hospital environment.

Voltage

dips, short

interruptions

and voltage

variations on

power supply

input lines

IEC 61000-4-11

<5 % UT

(>95% dip in

UT.)

for 0.5 cycle

<5 % UT

(>95% dip in

UT.)

for 1 cycle

70% UT

(30% dip in UT)

for 25 cycles

<5% UT

(>95 % dip in

UT)

for 250 cycles

<5 % UT

(>95% dip in UT.)

for 0.5 cycle

<5 % UT

(>95% dip in UT.)

for 1 cycle

70% UT

(30% dip in UT)

for 25 cycles

<5% UT

(>95 % dip in UT)

for 250 cycles

Mains power quality

should be that of a

typical commercial or

hospital environment. If

the user of the models

Fi-P requires continued

operation during power

mains interruptions, it is

recommended that the

models Fi-P be powered

from an uninterruptible

power supply or a

battery.

Power frequency

(50/60 Hz)

magnetic eld

lEC 61000-4-8

30A/m 30A/m Power frequency

magnetic elds 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.

Table 3: Guidance & Declaration - electromagnetic immunity concerning

Conducted RF & Radiated RF

Guidance & Declaration - Electromagnetic immunity

The model Fi-P is intended for use in.the electromagnetic environment specied

below. The customer or the user of the models Fi-P should assure that it is used

in such an environment.

Immunity test IEC 60601

test level

Compliance

level

Electromagnetic environment -

guidance

Conducted RF

lEC 61000-4-6

Conducted RF

lEC 61000-4-6

Radiated RF

lEC 61000-4-3

3 Vrms

150 kHz to 80

MHz

6 Vrms

ISM

frequency

band

3 V/m

80 MHz to 2.7

GHz

3V/m

Portable and mobile RF

communications equipment

should be used no closer to any

part of the models Fi-P, including

cables, than the recommended

separation distance calculated

from the equation applicable to the

frequency of the transmitter.

Recommended separation distance

d=1.2×P1/2

d=2×P1/2

d=1.2×P1/2 80 MHz to 800 MHz

d=2.3×P1/2 800 MHz to 2.7 GHz

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 meters (m).

Field strengths from xed RF

transmitters, as determined by an

electromagnetic site survey,a should

be less than the compliance level in

each frequency range.b

Interference may occur In the

vicinity of equipment marked with

the following symbol:

NOTE I At 80 MHz end 800 MHz. the higher frequency range applies.

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

propagation is aected by absorption and reection from structures, objects and

people.

a Field strengths from xed 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 xed RF transmitters, an

electromagnetic site survey should be considered. If the measured eld strength

in the location in which the model Fi-P is used exceeds the applicable RF

compliance level above, the model Fi-P should be observed to verify normal

operation. If abnormal performance is observed, additional measures may be

necessary, such as reorienting or relocating the model Fi-P.

b Over the frequency range 150 kHz to 80 MHz, eld strengths should be less

than 3V/m.

Table 4: Recommended separation distances between portable and mobile

RF communications equipment and the model Fi-P

Recommended separation distances between

portable and mobile RF communications equipment and the model

Fi-P

The model Fi-P is intended for use in electromagnetic environment in which

radiated RF disturbances is controlled. The customer or the user of the model

Fi-P can help prevent electromagnetic interference by maintaining a minimum

distance between portable and mobile RF communications equipment

(transmitters) and the model Fi-P as recommended below, according to the

maximum output power of the communications equipment.

Rated maximum

output power

of transmitter

Separation distance according to frequency of transmitter

150kHz to 80MHz

d=1.2×P1/2

80MHz to 800MHz

d=1.2×P1/2

800MHz to

2,7GHz

d=2.3×P1/2

0,01 0.12 0.12 0.23

0,1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the

recommended separation distance d in meters (m) can be estimated using the

equation applicable to the frequency of the transmitter, where P is the maximum

output power rating of the transmitter in watts (W) accordable to the transmitter

manufacturer.

NOTE I 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 aected by absorption and reection from structures, objects and

people.

14 Statement

Woodpecker reserves the right to change the design of the equipment,

the technique, ttings, instruction manual and the content of the original

packing list at any time without further notice. The pictures are only for

reference. The final interpretation rights belong to Guilin Woodpecker

Medical Instrument Co., Ltd.

ZMN-SM-039 V1.3-20200628

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