Guilin Woodpecker Medical Instrument Fi-G User manual

Contents
Introduction -------------------------------------------------------1
1 Product introduction-------------------------------------------1
2 Standard icons--------------------------------------------------9
3 Contraindications -------------------------------------------- 10
4 Installation and disassembly method of accessories ---- 10
5 Operation method --------------------------------------------11
6 Charging instruction----------------------------------------- 13
7 Safety precautions ------------------------------------------- 14
8 Cleaning, Disinfection, Sterilization and Maintenance 14
9 Troubleshooting---------------------------------------------- 22
10 After-sales service------------------------------------------ 23
11 Environment protection------------------------------------ 24
12 EMC-Declaration of comformity ------------------------ 24
13 Statement ---------------------------------------------------- 28

1
Introduction
Thank you for purchase Fi-G Hot Melting and Filling 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
Heat up and soften gutta-percha, and ll the gutta-percha into the root
canal after preparation. And the applied part is Gutta Percha Injecting
Needle.
1.2 Diagram of components and control buttons
The Fi-G is equipped with a display screen and a control button on
both the left and right sides. And the design of left and right sides are
perfectly symmetrical, which enables either left-hand or right-hand
operation;

2
1. Gutta Percha Injecting Needle
2. Gutta Percha Injecting Needle Protector
3. Limit switch 4. Thermal Protector Cap
5. Gutta-percha loading slot 6. Battery level
7. Temperature Level 8. “ON/OFF” button
9. Pushing ram 10. Battery cover
11. Charging indicator 12. Charging base
13. Power adapter plug 14. Power adapter unit
15. Connecting hole for power supply
16. Trigger
1) “ON/OFF” button:
a) In the OFF state, long press the left or right “ON/OFF” button can
turn on the power. After the power is turned on, the left and right displays
will be lit at the same time.
b) In the ON state, long press the left or right “ON/OFF”button can
turn o the power.
Note: If there is no operation for 10 minutes, the Hot Melting and
Filling Instrument will automatically shut down.

3
2) Temperature control button: ( Note: The temperature control button
and the “ON/OFF” button are the same button. After powers on, the
button acts as temperature control button. )
Lightly press the button to change the preset temperature for heating
the gutta-percha. The temperature will change in the sequence of
150℃→180℃→200℃→230℃ as shown in Figure 1, and back to
150°when you press the button in 230℃.
Figure 1 Preset temperature
Gutta Percha
Injecting Needle Temperature
25G 180℃-230℃
23G 180℃-200℃
20G 180℃-200℃
Table 1 Recommended temperature setting
3) Limit switch:
Keep pushing the limit switch to pull the Pushing ram backward.
Warning:
Do not pull the Pushing ram backward without pressing the limit
switch all the time.
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 Hot Melting and Filling Instrument will be shortened

4
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 inside heating chamber.
When the Hot Melting and Filling Instrument is in the heating
state, the temperature indicator will simultaneously display the current
temperature.
6) Charging base:
Firstly, connect the power adapter plug to the power adapter as shown
in Figure 2. Then connect the power adapter to the charging base as
shown in Figure 3 and connect the power adapter to a standard socket.
Place the Hot Melting and Filling Instrument correctly on the charging
base as shown in Figure 4, so that the charging connector under the Hot
Melting and Filling Instrument can be reliably connected to the output
connector of the charging base. When the Hot Melting and Filling
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
Hot Melting and Filling Instrument is not placed on the charging base,
the indicator will ashes in yellow and green alternately. When the Hot
Melting and Filling 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 Hot Melting and Filling 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 2 Installation of power adapter Figure 3 Connection to power supply

5
Figure 4 Charging
7) Gutta-percha loading slot:
Note: Only one gutta-percha can be loaded into it for a time.
8) Thermal Protector Cap:
The design of Thermal Protector Cap is to protect the oral soft tissue
and lip from scalding.
Note: Before being used to dierent patients or before each use, please
clean, disinfect and sterilize the Thermal Protector Cap.
9) Gutta Percha Injecting Needle
Before use, the Gutta Percha Injecting Needle and the Fi-G must be
connected and tightened with the wrench provided by our company to
prevent the needle from falling o or the gutta-percha leakage during use.
But do not to screw too tight. Here we provide a variety of needles with
dierent sizes (Please refer to Table 2), and the needles can be pre-bent
depending on the application. ( Note: Store unused Gutta Percha Injecting
Needles in a sealed environment, as the Gutta Percha Injecting Needle
are made of silver and may discolor due to oxidation caused by long-
term exposure to air ). Please use the wrench provided by the company to
connect, disassemble and pre-bend the Gutta Percha Injecting Needle.
Note: When replace the Gutta Percha Injecting Needle, please first
power off and wait for 5 minutes. Only after the Hot Melting and

6
Filling Instrument and Gutta Percha Injecting Needle cool down, the
replacement can start. When the Gutta Percha Injecting Needle is still
hot, to avoid scalding, please do not pre-bent or replace the Gutta Percha
Injecting Needle.
Warning:
Before being used to different patients or before each use, please
clean, disinfect and sterilize the Gutta Percha Injecting Needle. It is
recommended that users follow manufacturer's written instructions to
properly disinfect the device; the Hot Melting and Filling Instrument
cannot be autoclaved. Do not autoclave the Hot Melting and Filling
Instrument and charging base or place them in chemical disinfectants.
10) Wrench:
The wrench is used to tighten the Gutta Percha Injecting Needle and
its connection to Hot Melting and Filling Instrument. After tighten the
Gutta Percha Injecting Needle, the needle can be bent to any suitable
angle with wrench. Do not use other instruments to pre-bend the needle
other than the wrench provided by manufacturers.
11) Cleaning brush:
To remove remaining material from inside the heating or loading slot,
set the temperature to 150℃, express any remaining material and then
turn off the Hot Melting and Filling Instrument. Insert cleaning brush
through the back of the Hot Melting and Filling Instrument, and then pull
it out through the nose of the Hot Melting and Filling Instrument. Do not
put any cleaner or chemicals on the cleaning brush before inserting it into
the chamber.
1.3 Device includes
1. Hot Melting and Filling Instrument
2. Charging base
3. Power adapter with cord
4. Gutta Percha Injecting Needles
5. Thermal Protector Cap

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6. Gutta Percha Injecting Needle Protector
7. Cleaning brush
8. Pushing ram
9. Wrench
10. Instruction Manual
11. Qualied Certication
12. Warranty card
13.Packing list
Model Gauge Length
20G 22mm 20G 22mm
20G 24mm 20G 24mm
20G 28mm 20G 28mm
23G 24mm 23G 24mm
23G 28mm 23G 28mm
25G 24mm 25G 24mm
Table 2 Models of Gutta Percha Injecting Needles
1.4 Introduction and scope of application
1.4.1 Features:
a) Symmetrical two-sided display and operation button design for left
or right hand operation.
b) Cordless design for Hot Melting and Filling Instrument eectively
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) Safe protecting system. If there is no operation for 10 minutes, the
Hot Melting and Filling Instrument will automatically shut down.
1.4.2 Scope of application:
Only used in endodontic lling with gutta-percha or root canal sealant.
Fi-G is equipped with Gutta Percha Injecting Needle and Thermal
Protector Cap to heat up and soften gutta-percha to backll root canal.

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1.5 Product specications
Sizes
Hot Melting and Filling
Instrument
31.9mm×152.5mm×114.9mm
Charging base 75.5mm×149.7mm×62.6mm
Weight
Hot Melting and Filling
Instrument
170g
Charging base 207g
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 (First charging needs 3 h)
Power supply Input AC100V-240V 50/60Hz
800mA
Output DC15V/1.6A
Battery capacity Chargeable battery 2000mAh
Heater Rating 10W
1.7 Environmental parameters
Working condition
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.

9
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 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
Rectilinear motion 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℃

10
3 Contraindications
1. People who are allergic to known natural latex and metals such as
stainless steel, silver, copper, etc. are prohibited 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.
4 Installation and disassembly method of
accessories
4.1 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 2,
Figure 3, and Figure 4.
4.2 Installation, disassembly and pre-bent of Gutta Percha Injecting
Needle
Note: In order to prevent from scalding, when replace the Gutta Percha
Injecting Needle, please rst power o and wait for 5 minutes. Only after
the heating chamber cools down, the replacement can start.
1. Power o the device and wait for 5 minutes until the Hot Melting
and Filling Instrument cools down. And then use wrench to disassemble
the needle in counter-clockwise direction.
2. Place the used needle in the dedicated container.
3. Select needed Gutta Percha Injecting Needle (20ga, 23ga or 25ga.
Please refer to Table 2 for details.), and tighten the needle to the Hot
Melting and Filling Instrument in clockwise direction. Please be cautious
not to over tighten.
4. Use wrench to bend the needle to needed angle.
4.3 Installation and disassembly of Thermal Protector Cap
Start installation and disassembly from head part of the Hot Melting
and Filling Instrument.
4.4 Removal and replacement of battery
When replace the battery, first loosen the fixing screw with a

11
screwdriver, then remove the battery cover, next remove the old battery,
replace it with a new one, and nally cover the battery cover and tighten
the screws.
Warning:
Improper replacement of lithium batteries may result in unacceptable
risks,so replacement of lithium batteries requires trained personnel.
4.5 Installation and disassembly of pushing ram
When pulling out the pushing ram, the limit switch must be kept
pressed.
The pushing ram can only be plugged in or unplugged from tail part of
the Hot Melting and Filling Instrument.
5 Operation method
Note: During use, please do not contact the heating part of the Hot
Melting and Filling Instrument. Before use, remember to install the
Thermal Protector Cap to prevent users or patients from scalding.
1. Choose Gutta Percha Injecting Needle
Choose suitable Gutta Percha Injecting Needle (20ga, 23ga or 25ga)
according to the situation of patient. And tighten the Gutta Percha
Injecting Needle and handpiece (Note: not too tight). When using, the
Gutta Percha Injecting Needle can rotate to suitable angle within the
range of 360°in clockwise direction and counterclockwise direction. And
you can also use wrench to pre-bend the needle and adjust it to a better
operation angle as per your needs.
Warning:
When install the Gutta Percha Injecting Needle, please be sure that
the device is o and the head part of the device is cooling down. (About
5 minutes after shutdown of the Hot Melting and Filling Instrument, the
head part of it can cool down to the temperature that allows people to
touch.)

12
2. Choose the gutta-percha
Choose suitable gutta-percha for the device. Before loading it into the
loading slot, pull the pushing ram back (do not pull out) to empty the
loading slot with pressing the limit switch all the time, and then tilt the
head of the Hot Melting and Filling Instrument down. After tilting the
head part for an certain angle, put the gutta-percha into the loading slot,
and then use the pushing ram to push the gutta-percha into the heating
chamber completely (Note: only one gutta-percha stick can be placed at
a time). When the gutta-percha completely enters the heating chamber,
the black marker circle of the pushing ram will fully advance into the Hot
Melting and Filling Instrument. Failure to fully t the gutta-percha into
the heating chamber will result in function failure of the device.
3. Power on
After powering on with long press on “ON/OFF” button, the device
will automatically heat up to the preset temperature. If you want to
change the preset temperature, please continuously press the temperature
control button until the display screen displays the needed temperature
value. After each press, the temperature will change once in the sequence
of 150℃->180℃->200℃->230℃. And it will back to 150℃ when
you press the button while at 230℃. During operation, please refer to
Table 1 Recommended temperature setting to set suitable temperature.
One second after setting suitable temperature, the display screen will
automatically skip to display the actual heating temperature. And it will
heat up until reach the preset temperature. Pull the trigger to push the
pushing ram forward until there is a small amount of extrusive gutta-
percha in the needle.
Note: The displaying temperature is the temperature inside the heating
chamber.
4. Canal obturation
Install the Thermal Protector Cap at the connecting part of Gutta
Percha Injecting Needle and Hot Melting and Filling Instrument, and
wipe the lling material from the needle with gauze and alcohol. Note:
The needle is hot at this time, and the needle starts lling from the bottom
of the root canal to reduce or avoid the generation of bubbles. Place the
needle at the bottom of the root canal. Pull the trigger to squeeze the
gutta-percha, and slowly retract the needle until reach the crown hole.
Warning:
When the trigger is squeezed to ll the gutta-percha without retracting

13
the needle, the needle may break. While the gutta-percha is still hot, use a
medical vertical presser to squeeze down. If there are bubbles in the root
canal, use a small amount of material to ll the root canal for many times.
Use a little more material for each lling and use vertical presser to press
it down.
5. Replacement of gutta-percha
When the trigger is pushed forward to push the push ram to make a
"click" sound. it indicates that the gutta-percha in the Hot Melting and
Filling Instrument has been used up. And it is necessary to load a new
gutta-percha stick in time. When loading another gutta-percha stick,
make sure the Hot Melting and Filling Instrument has cooled to room
temperature. When the previous gutta-percha has been completely
squeezed out, then according to step 2, re-select the appropriate gutta-
percha for loading.
Warning:
Do not replace the gutta-percha stick in the heated state, otherwise it
may cause scalding or damage the Hot Melting and Filling Instrument.
6. After operation, the remaining materials in the heating chamber
must be cleaned, and the relevant accessories must be cleaned, disinfected
and sterilized. For details, see Chapter 8.
6 Charging instruction
6.1 Use corresponding charging base for charging: Connect the power
adapter to the charging base, and connect to power supply. And then
correctly place the Hot Melting and Filling Instrument in the charging
base. When the Hot Melting and Filling Instrument is not placed on the
charging base, the indicator will ashes in yellow and green alternately.
When the Hot Melting and Filling 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. Under normal situation, the
charging takes about 2.5h.
6.2 The battery used in this product has no memory and can be used at
any time or charged at any time.
6.3 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.

14
7 Safety precautions
1. Do not use instruments other than the provided wrench to install,
disassemble or pre-bent Gutta Percha Injecting Needle.
2. Do not knock or scratch the Hot Melting and Filling Instrument.
3. Keep heat carrier accessories such as Hot Melting and Filling
Instrument, Gutta Percha Injecting Needle, Thermal Protector Cap 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 clean, disinfect and sterilize the accessories such as Gutta
Percha Injecting Needle, Thermal Protector Cap and wrench.
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 Thermal Protector Cap and
needle under heating state. If you need to replace the needle, please rst
power o and wait for 5 minutes. Five minutes later, if the Hot Melting
and Filling Instrument totally cools down, replace the needle.
7. The needle must be correctly installed to prevent from falling o or
gutta-percha leakage during operation.
8. Do not use excessive force when pre-bending the injection needle to
prevent the needle from breaking. When the needle is bent or worn, the
gutta-percha owing ability may be deteriorated, and the operator should
replace the new needle in time according to the clinical condition;
9.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.
8 Cleaning, Disinfection, Sterilization and
Maintenance
The cleaning, disinfection and sterilization of Gutta Percha Injecting
Needle, Gutta Percha Injecting Needle Protector, Thermal Protector
cap and Wrench are as follow .Unless otherwise stated, they will be
hereinafter referred to as “products”.

15
Warnings
The use of strong detergent and disinfectant (alkaline pH>9 or acid
pH <5) will reduce the life span of products. And in such cases, the
manufacturer takes no responsibility. This device shall not be exposed to
high temperature above 138℃.
Processing limit
The products 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 products. The maximum number
of sterilizations for Gutta Percha Injecting Needle and Gutta Percha
Injecting Needle Protector is 300 times. For Thermal Protector cap, it is
15 times. And for wrench, it is 1000 times.
8.1 Initial processing
8.1.1 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.
8.1.2 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. Squeeze out all the remaining Gutta Percha materials in the
Backfilling Handpiece and ensure that the Gutta Percha materials
injected from the Gutta Percha Injecting Needle exceed 30mm, that is,
ensure that all the residual Gutta Percha materials in the Gutta Percha
Injecting Needle are replaced.
2. Remove the Pushing Ram, then turn off the power and let the
Backlling Handpiece sit on the base for 5 minutes to cool the hot part to
room temperature
3. Clean the remaining Gutta Percha material on the Push Ram with a
soft cloth stained with 75% alcohol and place it on a clean tray.

16
Notes:
The water used here must be pure water, distilled water or deionized
water.
8.2 Preparation before cleaning
Steps
Tools: Wrench ,tray, clean and dry soft cloth.
1. Remove the Gutta Percha Injecting Needle Protector and Thermal
Protector cap from the handle and place them in a clean tray.
2. Remove the Gutta Percha Injecting Needle from the handle with
the wrench provided by guilin woodpecker medical instrument co., LTD.
Then Put them into a clean tray.
3. Clean the surface of Gutta Percha Injecting Needle, Gutta Percha
Injecting Needle Protector, Thermal Protector cap and wrench until no
dirt can be seen on the surface. Then dry all accessories with a soft cloth
and put them into a clean tray. Cleaning agent can be pure water, distilled
water or deionized water.
8.3 Cleaning
The cleaning should be performed no later than 24 hours after the
operation.
The cleaning can be divided into automated cleaning and manual
cleaning. Automated cleaning is preferred if conditions permit.
8.3.1 Automated cleaning
•The cleaner is proved to be valid by CE certificationin accordance
with EN ISO 15883.
▪The cleaning procedure is suitable for the product, and the irrigating
period is sucient.
It is recommended to use a washer-disinfector in accordance with
EN ISO 15883. For the specic procedure, please refer to the automated
disinfection section in the next section “Disinfection”.
Notes:
a) The cleaning agent does not have to be pure water. It can be distilled
water, deionized water or multi-enzyme. But please ensure that the
selected cleaning agent is compatible with the product.
b) In washing stage, the water temperature should not exceed 45 °C,
otherwise the protein will solidify and it would be dicult to remove.
c) After cleaning, the chemical residue should be less than 10mg / L.

17
8.4 Disinfection
Disinfection must be performed no later than 2 hours after the cleaning
phase. Automated disinfection is preferred if conditions permit.
8.4.1 Automated disinfection-Washer-disinfector
·The Washer-disinfector complies with EN ISO 15883.
·Use high temperature disinfection function. The temperature does not
exceed 134 ° C, and the disinfection under the temperature cannot exceed
20 minutes.
·The disinfection cycle is in accordance with the disinfection cycle in
EN ISO 15883.
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
products are 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, 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) Cleaning: (c1) The cleaning procedure should be suitable for the
product to be treated. The flushing period should be sufficient (5-10
minutes). Pre-wash for 3 minutes, wash for another 5 minutes, and rinse
it for twice with each rinse lasting for 1 minute. (c2) In the washing stage,
the water temperature should not exceed 45 °C, otherwise the protein
will solidify and it is dicult to remove. (c3) The solution used can be
pure water, distilled water, deionized water or multi-enzyme solution,
etc., and only freshly prepared solutions can be used. (c4)During the use
of cleaner, the concentration and time provided by manufacturer shall be
obeyed.

18
d) Disinfection: (d1) Direct use after disinfection: temperature ≥ 90℃,
time≥ 5 min or A0 ≥ 3000.
(d2)Sterilize it after disinfection and use: temperature ≥ 90℃, time ≥ 1
min or A0 ≥ 600.
(d3) For the disinfection here, the temperature is 93 ° C, the time is 2.5
min, and A0>3000.
e) Only distilled or deionized 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).
f) After cleaning, the chemical residue should be less than 10mg / L.
g) The air used for drying must be ltered by HEPA.
h) Regularly repair and inspect the disinfector.
8.5 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.
8.6 Inspection and maintenance
In this chapter, we only check the appearance of the product. After
inspection, ensure that there is no problem.
8.6.1 Check the product. If there is still visible stain on the product
after cleaning/ disinfection, the entire cleaning/disinfection process must
be repeated.
8.6.2 Check the product. If it is obviously damaged, smashed,
detached, corroded or bent, it must be scrapped and not allowed to
continue to be used.