Osstem Implant PLA-0100C SlowJec Plus Device User Manual

Osstem Implant PLA-0100C SlowJec Plus Device

Dear SlowJec plus customers, Thank you very much for using our product, SlowJec plus. For correct use and maintenance of the product, make sure to read the user manual thoroughly before use and also store the Product Warranty document in a safe location.

Overview

1. Purpose of Use
   The product is a cordless anesthesia device that can be used to inject anesthetic at constant speed by controlling the motor while anesthetizing the oral cavity.

2. Users
   A dental clinic worker with a dental treatment license at hospitals, dental clinics and so on.

3. Prohibition
   Do not use the product’s main body, cartridge, cradle, or AC adapter for other purposes than the intended purpose of use.

4. Precautions
   Prior to use, carefully read the safety precautions. The following items are used to prevent risk factors that can harm users and to guarantee safe use of the product. So, be fully familiarized with them before use.

DANGER
Only use a dedicated Lithium polymer battery for the product. Other types of battery cannot be used.

WARNING

• When injecting anesthetic into a patient by using the product, make sure to properly adjust the amount of injection depending on whether a patient is a pregnant woman, breast feeding woman, woman at childbearing age, infant, kid or elder.
• Connect the authentic cartridge included in the package only.
• After use, the cartridge is likely to cause infection if used again. So, do not reuse it without sterilizing it.
• Needle is for single use only. Do not reuse it.
• Do not touch the AC adapter, cradle or product wi th wet hands. It can cause electrical shocks.
• To prevent electrical shocks, you must connect the device to a power supply with protection ground only.
• Do not leak water or chemicals onto the top of the main body or cradle. It can cause electrical shocks or damages to the electrical circuits.
• Do not place it near the highly explosive or flammable materials.
• Do not disassemble or deform the product.
• Be careful not to drop this product
•  Before charging the product, make sure to correctly mount the main body in the cradle slot and when it is correctly mounted, check if the cradle lamp is lit in orange .
• If there is leakage inside the main body, it can cause malfunctions to the main body, so stop using it immediately and ask the manufacturer to repair it.
• If the battery fluid gets into your eyes, there is a risk of blindness. Seek medical attention immediately.
• If the main body has not been used for a long time, check all the above items one more time before starting to use it again.
• Keep your mobile ph one or wireless RF communication device as far away from the device as possible since they can affect operation of the medical electronic devices.
• When charging the main body, you can only use the dedicated cradle for the product. You cannot use other similar types of chargers.
• On the charging terminal of the main body and the cradle, do not place any other objects (ex. Metal, coin, wire, plastic and so on).

CAUTION

• Do not use or place the product in the environment with direct sunlight, inside the car under the bright sun , near the fireplace, or source of fire where the temperature is very high
• Before replacing the ample or cartridge, make sure to power off the ma in body. If you replace it when the power is on, it can cause malfunctions. when the power is on, it can cause malfunctions.
• Charge the battery if the battery level is low before use.Charge the battery if the battery level is low before use.
• If chemical,, solvent, or detergent comes in contact with the main body, solvent, or detergent comes in contact with the main body, it can cause it can cause decolorization or deformation, so decolorization or deformation, so please wipe it off immediately. please wipe it off immediately.
• The product can be used indoors only.The product can be used indoors only.

NOTICE

• There is no need for additional training before using the device
• The product can be used regardless of a patient’s age, gender , nationality or
• A user is responsible for controlling, maintaining and inspecting the product.

Product Features

1. There are a total of 4 buttons (an inject button, a stop button, a decelerate button, and a power button).
2. You can switch between manual and auto modes.
3. You can accelerate or decelerate the speed in manual mode. (Level 1 level 2 level 3 level 2 level 1)
4. You can switch from auto mode to manual mode.
5. You can adjust the voice volume. (0~3 levels)
6.  The LED displays the amount of ample injection a nd the ample injection pressure during injection.
7. Injection level: 25%, 50%, 75%, 100% (LED with step of
8. Injection pressure: Level 1 Level 2, Level 3, Level 4 (LED with step of 1
9. Pay attention to the following requirements for the environment and conditions of use.
10. Environment: Do not use it in a place with high humidity such as a bathroom.
11. Environment of use
12. Room temperature: 10℃ ~ 35℃
13. Relative humidity: 10% ~ 75%
14. Air pressure: 700hPa ~ 1060hPa
15. Transportation/Storage environment
16. Recommen ded to t ransport /store the product within 10℃ ~ 50℃.
17. Relative humidity : 10% ~
18. Air pressure: 500hPa ~ 1060hPa

Part Names and Functions

Product Package

1. Main body: Mount the cartridge and inject anesthetic.
2. Cartridge: Mount the needle and the anesthetic ample.
3. Cradle: Hold the main body safely and allow the battery to be charged.
4. AC adapter: Supply power to the main body and charge the battery.

Descriptions of the exterior of the main body

1. Cartridge Assembly
2. Area where the cartridge is assembled
3. Inject button
4. Press the button to start injection or change the injection speed.
5. Long press for more than 1 sec the button in initial condition to remove bubbles.
6. Stop button
7. Press the button to stop injection.
8. Long press the button in initial condition to switch between manual and auto modes.
9. Decelerate button
10. Press the button to reduce the injection speed.
11. Long press the button while stopped to return to the initial condition.
12.  Long press the button in initial condition to set the voice volume.
13. Display
14. Area to display the injection speed and the status information.
15. LED
16. Area to display the amount of injection and the injection pressure.
17. Power button
18. Press the button to turn On/Off the power.
19. Short press for less than 1 sec the button while stopped or in initial condition to check the battery level.
20. Grip Cove
21. Two types of grips for users’ convenience
22. Speaker
23. Speaker to output voices

Descriptions of the exterior of the cradle

1. Complete charging LED (Green lamp)
2. Lit in green if the charging is completed.
3. Charging LED (Orange lamp)
4. Lit in orange if the charging is still i n progress
5. AC adapter connector
6. 5V/2A adapter connector
7. Holder
8. Place the main body in here.

LCD screen

How to Use

Cautions before use

1. Be fully familiarized with how to use the device and check if the product is powered up with no problem.
2. Check if the battery level is high enough. If not, you can fully charge the battery for use.
3. To prevent infection, you must sterilize the cartridge in a high-pressure vapor sterilizer before use or reuse. (But the detailed setting of sterilization is based on the information provided by the sterilizer manufacturer)
4. You can only use a single-use, local anesthetic ample for dental clinics.

Cautions for Use

1. Only a qualified dentist or dental worker can use the product.
2. After purchasing the product for the first time, use the cradle to charge it sufficiently for at least 8 hours.
3. Do not use the device for any other purposes than the intended p urpose of use.
4. Use a single use needle only.
5. Make sure to dispose the needle after use.
6. Do not use a non standard needle.
7. Make sure to use the AC power cord with shielding.
8. Use the AC adapter provided by the manufacturer only.
9. Do not let the device come into direct contact with water. Do not use it in a location full of dusts.
10. Do not use the device in a location with flammable gas.
11. Since it can cause harms to the device or users, users or unqualified technicians are never allowed to disassemble or assembl e the device.
12. For electrical safety, do not place a heavy object on top of the charging power cable or place the device near the source of fire at high temperature.
13. If the device is operating abnormally, then stop using it immediately and turn off the power.

Charging

1. Insert the AC adapter cable into the back of cradle.
2. Insert the AC adapter into the electrical outlet with proper voltage level.
3. Insert the main body into the correct terminal of cradle.
4. When charging starts, the orange LED of cradle is lit.
5.  When charging is completed, the cradle LED switches from orange to green.

WARNING

• Do not use the cradle of the product to charge other product’s battery
• Do not touch the product with wet hands

CAUTION

• Place the main body in the cradle in such a way that the LCD wind ow is displayed at the front.
• When charging for a short period of time then the battery unit can be little too hot. You are recommended to charge it over a long period of time if possible.
• Use and store the charger in a location with relatively less temperature change a nd no direct sunlight.
• Do not use it in an environment with too high or low temperature. (1 ~ 35℃)

How to mount the cartridge

1. Insert the cartridge correctly into the front groove of the main body.
2. After inserting the cartridge into the main body, turn it Clockwise by 90 degrees to securely fix it.
3. Insert the ample from the front of the inside of the cartridge while keeping it tilted.
4. Rotate the needle at the front of cartridge Clockwise to securely fix it.

WARNING
Make sure to use a single use needle for mounting in the device.

CAUTION

• Make sure to turn off the power before mounting the cartridge.
• Do not remove the needle protection cap until the surgery.

How to dismount the cartridge

1. Press the button at the bottom of cartridge.
2. When the ample pops up, separate it with hands.
3. You can disassemble the cartridge in the reverse order of assembly.

CAUTION
Make sure to turn off the power before dismounting the cartridge.

How to fix the cover grip

1. Mount the cover grip (Standard type/Ring type) in the back of the main body.
2. After mounting it, slide it until you hear the clicking sound.

Press the “ “ part of the cover grip (Standard type/Ring type) and slide it to separate it.

Control

1. If you press the Power button, you can hear the voice guide and see p” on the display.
2. Short press for less than 1 sec ) the Power button once to display the battery level.
3. Long press for more than 1 sec ) the Decelerate button once in S tandby mode to hear the voice guide. You can press the Inject or Decelerate button to set the voice volume (Level 0 to 3) and deactivate the voice.
4. Press the Stop button to finish setting.
5. Long press the Stop button in initial condition once to switch between manual and auto modes.
6. Long press the i inject button once in initial condition to remove bubbles from the needle and enter standby mode.
7. After finishing the injection, initialization will be in progress automatically.
8. Press the Stop button during injection to stop injection.

NOTICE

• You can set the voice after initialization only.
• It is not possible to remove bubbles completely from the ample depending on the manufacturer. So, press the Inject button to visually check if bubbles are completely removed at level 1 spe ed.

Manual mode

1. After removing bubbles, short press the Inject button in Standby mode . Injection will start at level 1 speed and the speed will go up gradually if you repeat the step.
2. When injection is complete, initialization will take place automatically after 3 seconds.
3. Short press the Decelerate button during injection for gradual deceleration. (Ex: Level 3 → Level 2 → Level 1)
4. Short press the Stop button during injection to stop injection. When stop ped, short press the Inject button to resume injection at level 1 speed.

Auto mode

1. After removing bubbles, short press the Inject button in S tandby mode to proceed
   with auto injection.

2. Injection will proceed at level 1 (Low speed) for 20 seconds and then at level 2 (Mid
   speed) for 10 seconds. Finally, the remaining amount of ample will be injected at
   level 3 (High speed) for 40 seconds.

3. When injection is complete, initialization will take place automatically after 3 seconds

4. Short press the Inject or Dece lerate button during injection to switch to manual mode t emporarily . The speed during auto injection will go up or down by one level and once initialization is done, it will switch to a utomatic mode.

5. Short press the Stop button during injection to stop inj ection When stopped, short press the Inject button to resume injection at the level that it was previously stopped.

Auto power off
If you don’t operate it for 5 minutes, then the power will be automatically turned off to prevent energy wastes or inadequate malfunctions.

Amount of injection and injection pressure displays

1. The LED displays the amount of injection and the injection pressure.
2. The amount of injection is displayed in 4 levels. (One step of LED is 25%) Each time it is increased, one mor e LED level will be lit and you will hear the beeping sound.
3. Injection pressure is displayed in 4 levels. (One step of LED is one level). Each time it is increased, one more LED level will be lit.

Finished Use and Product Separation

1. Power off
2. After using the device , long press the Power button to turn off the power.
3. Cartridge separation
4. Separate the ample and the needle. Separate the cartridge from the main body and wash the cartridge. .

How to Store and Manage the Product after Use

Storage

1. Make sure to charge it in the cradle after use.
2. When you don’t charge or use the cartridge, keep it in a separate location.
3. Store it at the room temperature with no direct sunlight.
4. If it is left dormant for a long time, then remove the cradle plug and store it in a cool and dry place with no direct sunlight.

Washing

1. Spray microorganism infection prevention detergent or ethanol based solution to clean and soft patch but do not apply excessive force or use a sharp edged object.
2. Do not let alien substance such as detergent or water enter the inside.
3. Make sure to sterilize the cartridge before use.

WARNING

• Do not ever wipe off the main body with solvent such as strong acid or benzene.
• Do not operate the main body with wet hands or polluted hand s.

CAUTION
Refrain yourself from wiping off the main body with wet cotton or cloth because it can caus e electrical leakages.

Sterilization method

1. Sterilization item: Cartridge only.
2. You are recommende d to use the high pressure vapor based autoclaving sterilization.

WARNING

• Do not perform autoclaving on the main body or cradle.
• Do not ever wipe off the main body with solvent such as strong acid or benzene.
• If you perform autoclaving with the device where liquid is contained, then it can decolorize the surface or affect the internal parts. Make sure that liquid does not enter  the autoclave equipment.

CAUTION

• Make sure to store it in a location with no adversarial effects of air pressure, temperature, humidity, air circulation, sunlight, dust, salt or sulfurs and so on.
• Be careful when you touch it right after sterilization because it is very hot.

Repair and Inspection

1. To guarantee accurate functionalities, you are recommended to inspect the device at least once a year.
2. Ask the seller to inspect it.

Safety System

If excessive current is consumed during anesthetic injection, the power will be turned off to prevent shutting down of the battery. Make sure to fully charge the battery for use. But if the safety system continues to show the same pr oblem repeatedly, then it means that the main body circuit or battery has a problem, so ask your seller to repair it.

Troubleshooting

If the main body is not powered up even after you press the power on/off switch

1. If the battery is discharged or if the main body is left unused for a long time without charging
2. Charge the battery for use and if the power supply is still failed, then replace the battery.
3. If the internal fuse is burned out
4. Ask the seller to repair it.

If the battery does not get charged

1. If the battery temperature is high or low
2. If the battery temperature is lower than 0℃ or higher than 40℃, charging can fail. Right after the charging is complete, the temperature of battery might rise little bit, but if it is overheated then contact your seller.
3. If the main body is not correctly mounted in the cradle
4. Insert the main body correctly into the cradle slot.
5. If the AC adaptor mounted in the cradle is not the one provided in the package
6. Internal fuse might be blown up, so ask the seller for help. In this case, you need to replace internal parts. So, please be careful.

If it is powered off during operation

1. If the battery is discharged
2. Use it after the battery is fully charged.
3. If it is overloaded
4. In case of overload, the power will be automatically turned off. Long press the Power button to turn on the power of the main body for use.

Product Disposal

Please, discard it according to the laws and regulation of your country. If there is some uncertainty, ask the seller.

Guides and declaration by the manufacturer – Electromagnetic field emission

The product is guaranteed to operate in the following electromagnetic field environment.
Emission test| Conformity| Electromagnetic field environment – guide

RF emission CISPR11

|

Group 1

| The product generates RF energy only for its internal function. Therefore, RF emission level is low and it does not cause any interferences with the neighboring

electronic devices.

RF emission CISPR11

|

Class B

| The product is suitable for use in a facility that is directly connected to the low voltage power supply network that supplies power to household facilities or household

buildings.

Harmonics emission

IEC61000-3-2

| Not

applicable

| –
Voltage    change/flicker emission

IEC61000-3-3

| Not applicable|

–

Guides and declaration by the manufacturer – Electromagnetic field immunity

The product is guaranteed to operate in the following electromagnetic field environment.
Immunity level| IEC60601 test level| Conformity level| Electromagnetic   field

environment – guide

Electrostatic discharge(ESD) IEC61000-4-2| ±(2,4,6) 8kV contact

±(2,4,8) 15kV air

| ±(2,4,6) 8kV contact

±(2,4,8)15kV air

| The floor should be made of wood, concrete or ceramic tile. If the floor is covered with synthetic materials, then relative humidity should be at

least 30%.

Quick    instantaneous transient effect/burst IEC61000-4-4| For     ±2kV power cables

For ±1kV input/output

power cables

| For     ±2kV     power cables

For ±1kV input/output

power cables

| Power quality should be ideally at the level of commercial use or hospital.
Surge

IEC61000-4-5

| ±1kV line-to-line

±2kV line-to-ground

| ±1kV line-to-line

±2kV line-to-ground

Power             supply frequency’s magnetic field

IEC61000-4-8

| 30A/m| 30A/m| Magnetic field of the power            supply frequency should be ideally at the level of typical commercial use

or hospital.

Voltage    drop    and instantaneous blackout and voltage change

IEC61000-4-11

| <5% Ut with 0.5 cycles (Ut voltage dropped to >95%)

<40% Ut 5 cycles

(Ut voltage dropped to >60%)

<70% Ut 25 cycles

(Ut voltage dropped to >30%)

<5% Ut with 5 seconds

(Ut voltage dropped

to >95%)

| <5% Ut 0.5 cycles

(Ut voltage dropped to >95%)

<40% Ut 5 cycles

(Ut voltage dropped to >60%)

<70% Ut 25 cycles

(Ut voltage dropped to >30%)

<5%     Ut    with    5 seconds

(Ut voltage dropped

to >95%)

| Power quality should be ideally at the level of commercial use or hospital.

If a user needs continuous power supply in case of blackout, then use of UPS or battery is recommended.

Conductive          RF| 3Vrms| 3Vrms| If you use a mobile or
electromagnetic field IEC61000-4-6

Radiative              RF

electromagnetic field IEC61000-4-3

| 150kHz to 80MHz 3V/m

80MHz to 2.7GHz

|

3V/m

| portable RF wireless communication device, then make sure to maintain the

separation greater than                  the

recommended separation   calculated based       on       the transmission frequency applied at every part of      the      product including the cable.

d = 1.2 √P

d = 1.2 √P 80MHz to 800MHz

d = 2.3 √P 800MHz

to 2.5GHz

P stands for the max rated output power of transmitter (W), which is designated by the transmitter manufacturer, d is the recommended separation expressed in the unit of meter (m).

The electromagnetic field strength for a fixed RF transmitter is determined by the on- site investigations of the electromagnetic fields, but with regard to Remark 3.1, it should be ideally below the level set in

each frequency band.

---|---|---|---
 |  |  | There can be some interference   near   a device that emits non- ionizing electromagnetic radiation    (IEC60417-

1:2002 5140).

---|---|---|---
Remark 1 : Ut is the AC voltage before the test level is applied.
Remark 2 : A higher frequency range is applied in the frequency bands of 80MHz and 800MHz.
Remark 2.1 : The actual strength of the electromagnetic field for fixed transmitters such as cell phones, amateur radio (HAM), AM and FM radio broadcasting, TV broadcasting and so on cannot be theoretically predicted with high accuracy. Before you can evaluate the EMI environment due to fixed RF transmitters, you must consider the possibility for on-site investigation of EMI. If the equipment’s magnetic field strength measured at the location of equipment exceeds the above RF conformity level, then check if the equipment operates properly. If the sign of abnormality is observed, then additional actions can be required such as

change of the direction or re-positioning.

Remark 2.2 : In the frequency bands of 150kHz – 80MHz, the field strength should be less than or

equal to 3V/m.

Guides and declaration by the manufacturer – Recommended separation of a mobile or portable

RF wireless devices.

A user can prevent EMI by maintaining the minimum separation from the equipment to a

portable or mobile RF communication device based on its max output power.

Max    rated    output power of transmitter| Separation by transmitter frequency (m)
150kHz to 80MHz

d = 1.2 √P

| 80MHz to 800MHz

d = 1.2 √P

| 800MHz to 2.5GHz

d = 2.3 √P

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
If the transmitter exceeds the max output power not shown above, then the recommended separation, d(m) can be estimated based on the equation for transmitter’s frequency. Where P stands for the max rated output power for a transmitter in the unit of Watt according to the

transmitter manufacturer.

A higher frequency range is applied in the frequency bands of 80MHz and 800MHz.
The guide is not applicable to all the situations. EMI is affected by absorption or reflection by

structures, objects or humans.

Etc.

1. Manufacturer : OSSTEM IMPLANT CO,. LTD. Chair Business
2. Address : 192, Haebong ro, Danwon gu, Ansan si, Gyeonggi do, 15428, Korea
3. Applied part
4.  Needle
5. Ample
6. Battery : 3.7V 500 mAh, Li polymer
7. Adapter
8. Rated input voltage: 100 240V AC, 1A, 50/ 60Hz
9. Rated output voltage: 5V DC 2A
10. Steam Sterilization
11. Type : Pre vacuum
12. Temperature : 121
13. Time : 15 min
14. Limit of number : 100 cycle

Product Warranty

body (except for consumables)

Date of purchase| Month            Date               , 20( )
Model name| DSD-PLA-0100
Manufacturing number|
Item license number| Marked after registration is granted.
Customer| Name|
Telephone number|
Address|
Seller|

If the malfunction is caused by the negligence of a user, then they will be charged for the repair service.

• If the malfunction is due to careless handling, arbitrary repair or remodeling
• If the device malfunction or damage occurs because it was dropped during the movement after installation
• If the malfunction is due to use for other purposes than the intended purpose of use

FCC Compliance Statement

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 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 harmf ul interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to correc t the interference by one of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.

Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate this equipment. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

FCC Radiation Exposure Statement
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20 cm between the radiator and your body. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter.

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