| all | frequencies |
|
|
|
|
exhibits | applications |
|---|---|---|---|---|---|---|---|
| manual | photos | label | |||||
| app s | submitted / available | |||||||
|---|---|---|---|---|---|---|---|---|
| 1 2 |
|
User Manual | Users Manual | 987.75 KiB | July 06 2022 | |||
| 1 2 |
|
Internal Photos | Internal Photos | 278.82 KiB | July 06 2022 | |||
| 1 2 |
|
External Photos | External Photos | 269.19 KiB | July 06 2022 | |||
| 1 2 |
|
Label Location | ID Label/Location Info | 95.97 KiB | July 06 2022 | |||
| 1 2 | Block Diagrams | Block Diagram | July 06 2022 | confidential | ||||
| 1 2 |
|
Confidentiality Letter | Cover Letter(s) | 114.99 KiB | July 06 2022 | |||
| 1 2 |
|
LOA Letter | Cover Letter(s) | 170.16 KiB | July 06 2022 | |||
| 1 2 | Op Desc Antenna Spec | Operational Description | July 06 2022 | confidential | ||||
| 1 2 | Operational Description | Operational Description | July 06 2022 | confidential | ||||
| 1 2 | Parts List | Parts List/Tune Up Info | July 06 2022 | confidential | ||||
| 1 2 |
|
Pre-Approval Guidance Letter | Cover Letter(s) | 58.31 KiB | July 06 2022 | |||
| 1 2 |
|
RF Exposure | RF Exposure Info | 318.17 KiB | July 06 2022 | |||
| 1 2 | Schematics | Schematics | July 06 2022 | confidential | ||||
| 1 2 |
|
TSUP | Test Setup Photos | 210.28 KiB | July 06 2022 | |||
| 1 2 |
|
TSUP RF Exposure | Test Setup Photos | 363.81 KiB | July 06 2022 | |||
| 1 2 |
|
Test Report | Test Report | 880.55 KiB | July 06 2022 | |||
| 1 2 |
|
TSUP EMC | Test Setup Photos | 1.06 MiB | July 06 2022 | |||
| 1 2 |
|
Test Report EMC | Test Report | 1.37 MiB | July 06 2022 |
| 1 2 | User Manual | Users Manual | 987.75 KiB | July 06 2022 |
SlowJec plus
[DSD-PLA-0100]
User Manual | OS-UM-C020 | 2021.03.12 / Ver. 1.0 IMPORTANT NOTES For correct use of the device, make sure to read the user manual thoroughly before use. 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 SlowJec plus [DSD-PLA-0100]
User Manual | User Manual | 2021.03.12, Ver. 1.0 Dear SlowJec plus customers, Warranty document in a safe location. Table of Contents 01. Overview 02. Product Features 03. Part Names and Functions 04. How to Use 05. Finished Use and Product Separation 06. How to Store and Manage the Product after Use 07. Safety System 08. Troubleshooting 09. Product Disposal 10. Labels 11. Product Warranty 01. Overview 1. Purpose of Use 2. Users on. 3. Prohibition 4. Precautions 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. A dental clinic worker with a dental treatment license at hospitals, dental clinics and so Do not use the products main body, cartridge, cradle, or AC adapter for other purposes than the intended purpose of use. 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. Classification Level of risk, damage or severity Likely to cause fatal damages. DANGER WARNING CAUTION NOTICE Likely to cause physical injuries or device malfunctions. Likely to cause slight physical injuries or device malfunctions. Items that a user must comply with for safety reasons. MEDICAL - GENERAL MEDICAL EQUIPMENT E482378 AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH "ANSI/AAMI ES 60601-1 (2005) + AMD (2012)"
"CAN/CSA-C22.2 No. 6060-1 (2008) + (2014) Caution : Federal law restricts this device to sale by or on the order of a Attention : La loi fdrale limite la vente de cet appareil par ou sur l'ordre d'un dentist. dentiste. Symbol marks Descriptions Disposal of electrical medical devices: Once the product reaches its end of life, make sure to recycle it or separate it for safe disposal; this is to prevent environmental pollution and conserve resources. Manufacturer information: This symbol is followed by the name and address Read the user manual. of the device manufacturer Temperature limits Relative humidity limits Atmospheric pressure limits Keep it dry Cautions for handling. IEC 60601-1. Specific degree of electrical-shock protection against leakage current and protective earth. B-type equipment. DANGER used. DANGER WARNING Only use a dedicated Lithium polymer battery for the product. Other types of battery cannot be Utilisez uniquement une batterie lithium-polymre ddie au produit. Les autres types de batterie ne peuvent pas tre utiliss.
-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 with 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. before starting to use it again.
-If the main body has not been used for a long time, check all the above items one more time
-Keep your mobile phone 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). ATTENTION
- Lors de l'injection d'anesthsique un patient en utilisant le produit, assurez-vous d'ajuster correctement la quantit d'injection selon que le patient est une femme enceinte, une femme qui allaite, une femme en ge de procrer, un nourrisson, un enfant ou une personne ge.
- Connectez la cartouche authentique incluse dans l'emballage uniquement.
- Aprs utilisation, la cartouche est susceptible de provoquer une infection si elle est rutilise. Donc, ne le rutilisez pas sans le striliser.
- L'aiguille est usage unique. Ne le rutilisez pas.
- Ne touchez pas l'adaptateur secteur, la station d'accueil ou le produit avec les mains mouilles. Cela
- Pour viter les chocs lectriques, vous devez connecter l'appareil une alimentation avec une terre peut provoquer des chocs lectriques. de protection uniquement.
- Ne laissez pas couler d'eau ou de produits chimiques sur le dessus du corps principal ou du berceau. Cela peut provoquer des chocs lectriques ou endommager les circuits lectriques.
- Ne le placez pas proximit de matriaux hautement explosifs ou inflammables.
- Ne pas dmonter ou dformer le produit.
- Attention ne pas faire tomber ce produit.
- Avant de charger le produit, assurez-vous de monter correctement le corps principal dans la fente du socle et lorsqu'il est correctement mont, vrifiez si le voyant du socle est allum en rouge.
- S'il y a une fuite l'intrieur du corps principal, cela peut provoquer des dysfonctionnements du corps principal, alors arrtez de l'utiliser immdiatement et demandez au fabricant de le rparer.
- Si le liquide de la batterie entre en contact avec vos yeux, il existe un risque de ccit. Consultez immdiatement un mdecin.
- Si le corps principal n'a pas t utilis pendant une longue priode, vrifiez encore une fois tous les lments ci-dessus avant de recommencer l'utiliser.
- Gardez votre tlphone portable ou votre appareil de communication RF sans fil aussi loin que possible de l'appareil car ils peuvent affecter le fonctionnement des appareils lectroniques mdicaux.
- Lorsque vous chargez le corps principal, vous ne pouvez utiliser que le socle ddi au produit. Vous ne pouvez pas utiliser d'autres types de chargeurs similaires.
- Sur la borne de charge du corps principal et du socle, ne placez aucun autre objet (ex. mtal, pice de monnaie, fil, plastique, etc.). 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 main body. If you replace it NOTICE AVIS when the power is on, it can cause malfunctions.
-Charge the battery if the battery level is low before use.
-If chemical, solvent, or detergent comes in contact with the main body, it can cause decolorization or deformation, so please wipe it off immediately.
-The product can be used indoors only. AVERTIR
- N'utilisez pas ou ne placez pas le produit dans un environnement expos la lumire directe du soleil, l'intrieur de la voiture sous un soleil clatant, prs de la chemine ou d'une source d'incendie o la temprature est trs leve.
- Avant de remplacer l'ample ou la cartouche, assurez-vous d'teindre le corps principal. Si vous le remplacez lorsque l'appareil est sous tension, cela peut provoquer des dysfonctionnements.
- Chargez la batterie si le niveau de la batterie est faible avant utilisation.
- Si un produit chimique, un solvant ou un dtergent entre en contact avec le corps principal, cela peut provoquer une dcoloration ou une dformation, veuillez donc l'essuyer immdiatement.
- Le produit ne peut tre utilis qu' l'intrieur.
-There is no need for additional training before using the device.
-The product can be used regardless of a patients age, gender, nationality or weight.
-A user is responsible for controlling, maintaining and inspecting the product.
- Aucune formation supplmentaire n'est ncessaire avant d'utiliser l'appareil.
- Le produit peut tre utilis quel que soit l'ge, le sexe, la nationalit ou le poids du patient.
- Un utilisateur est responsable du contrle, de l'entretien et de l'inspection du produit. 02. Product Features power button).
(1) There are a total of 4 buttons (an inject button, a stop button, a decelerate button, and a
(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 and the ample injection pressure during injection. A. B. Injection level: 25%, 50%, 75%, 100% (LED with step of 25%) Injection pressure: Level 1 Level 2, Level 3, Level 4 (LED with step of 1 level)
(8) Pay attention to the following requirements for the environment and conditions of use. A. Environment: Do not use it in a place with high humidity such as a bathroom. B. Environment of use Room temperature: 10 ~ 35 Relative humidity: 10% ~ 75%
Air pressure: 700hPa ~ 1060hPa C. Transportation/Storage environment Relative humidity: 10% ~ 80%
Air pressure: 500hPa ~ 1060hPa Recommended to transport/store the product within -10 ~ 50. 03. Part Names and Functions 1. Product Package A. Main body: Mount the cartridge and inject anesthetic. B. Cartridge: Mount the needle and the anesthetic ample. C. Cradle: Hold the main body safely and allow the battery to be charged. D. AC adapter: Supply power to the main body and charge the battery. C D B A 2. Descriptions of the exterior of the main body A. Cartridge Assembly
-Area where the cartridge is assembled B. Inject button C. Stop button
-Press the button to stop injection. modes. D. Decelerate button
-Press the button to start injection or change the injection speed.
-Long press (for more than 1 sec) the button in initial condition to remove bubbles.
-Long press the button in initial condition to switch between manual and auto
-Press the button to reduce the injection speed.
-Long press the button while stopped to return to the initial condition.
-Long press the button in initial condition to set the voice volume.
-Area to display the injection speed and the status information. E. Display F. LED
-Area to display the amount of injection and the injection pressure. G. Power button
-Press the button to turn On/Off the power.
-Short press (for less than 1 sec) the button while stopped or in initial condition to check the battery level. H. Grip Cove I. Speaker
-Speaker to output voices
-Two types of grips for users convenience B C D E F G A I H 3. Descriptions of the exterior of the cradle A. Complete charging LED (Green lamp)
-Lit in green if the charging is completed. B. Charging LED (Orange lamp)
-Lit in orange if the charging is still in progress. C. AC adapter connector
-5V/2A adapter connector D. Holder
-Place the main body in here. D A, B C 4. LCD screen Display unit Mode Descriptions Power On Power Off Manual mode selection Displayed when power is On. Displayed when power is Off. Displayed when in manual mode. Auto mode selection Displayed when in auto mode. Voice setting Displayed when entering the setting menu. Volume control Displays the current volume. Bubble removal Displayed when bubbles are being removed. Low speed (Level 1) Displays the speed for manual mode injection. Mid speed (Level 2) Displays the speed for manual mode injection. High speed (Level 3) Displays the speed for manual mode injection. Auto Displayed when for auto mode injection. Initialization Displayed when initialization is in progress. Complete injection Displayed when injection is complete. Operation error Displayed when an error occurs. Battery check Displayed when checking the battery. 04. How to Use 1. Cautions before use up with no problem. use. A. Be fully familiarized with how to use the device and check if the product is powered B. Check if the battery level is high enough. If not, you can fully charge the battery for C. 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) D. You can only use a single-use, local anesthetic ample for dental clinics. 2. Cautions for Use A. Only a qualified dentist or dental worker can use the product. B. After purchasing the product for the first time, use the cradle to charge it sufficiently for at least 8 hours. C. Do not use the device for any other purposes than the intended purpose of use. D. Use a single-use needle only. E. Make sure to dispose the needle after use. F. Do not use a non-standard needle. G. Make sure to use the AC power cord with shielding. H. Use the AC adapter provided by the manufacturer only. I. Do not let the device come into direct contact with water. Do not use it in a location full of dusts. J. Do not use the device in a location with flammable gas. K. Since it can cause harms to the device or users, users or unqualified technicians are never allowed to disassemble or assemble the device. L. 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. M. If the device is operating abnormally, then stop using it immediately and turn off the power. 3. Charging A. B. C. WARNING ATTENTION CAUTION front. direct sunlight. AVERTIR l'avant. Insert the AC adapter cable into the back of cradle. Insert the AC adapter into the electrical outlet with proper voltage level. Insert the main body into the correct terminal of cradle. D. When charging starts, the orange LED of cradle is lit. E. When charging is completed, the cradle LED switches from orange to green.
-Do not use the cradle of the product to charge other product's battery
-Do not touch the product with wet hands
- N'utilisez pas le socle du produit pour charger la batterie d'un autre produit
- Ne touchez pas le produit avec les mains mouilles
-Place the main body in the cradle in such a way that the LCD window is displayed at the
- 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 and no
-Do not use it in an environment with too high or low temperature. (1 ~ 35)
- Placez le corps principal dans le berceau de manire ce que la fentre LCD s'affiche
- Lors de la charge pendant une courte priode, l'unit de batterie peut tre un peu trop chaude. Il est recommand de le charger sur une longue priode de temps si possible.
- Utilisez et stockez le chargeur dans un endroit avec relativement moins de changement de temprature et sans lumire directe du soleil.
- Ne l'utilisez pas dans un environnement temprature trop leve ou trop basse. (1 ~ 35) Cartridge Ample
-If the LED is not lit while the battery is charging, then it means that there is a problem in the internal circuit, so ask the seller to repair it for you NOTICE AVIS
- Si la LED ne s'allume pas pendant la charge de la batterie, cela signifie qu'il y a un problme dans le circuit interne, alors demandez au vendeur de le rparer pour vous 4. How to mount the cartridge A. Insert the cartridge correctly into the front groove of the main body. B. After inserting the cartridge into the main body, turn it Clockwise by 90 degrees to securely fix it. C. Insert the ample from the front of the inside of the cartridge while keeping it tilted. D. Rotate the needle at the front of cartridge Clockwise to securely fix it. Protrusion/Groove Rotate it Clockwise
- Make sure to use a single-use needle for mounting in the device.
- Assurez-vous d'utiliser une aiguille usage unique pour le montage dans l'appareil.
-Make sure to turn off the power before mounting the cartridge.
-Do not remove the needle protection cap until the surgery.
- Assurez-vous de couper l'alimentation avant de monter la cartouche.
- Ne retirez pas le capuchon de protection de l'aiguille avant la chirurgie. WARNING ATTENTION CAUTION AVERTIR NOTICE
-Refer to the user manual for more about how to use a single-use needle. AVIS usage unique.
- Reportez-vous au manuel d'utilisation pour en savoir plus sur l'utilisation d'une aiguille 5. How to dismount the cartridge A. Press the button at the bottom of cartridge. B. When the ample pops up, separate it with hands. C. You can disassemble the cartridge in the reverse order of assembly. Button CAUTION AVERTIR
-Make sure to turn off the power before dismounting the cartridge.
- Assurez-vous de couper l'alimentation avant de dmonter la cartouche. 6. How to fix the cover grip A. Mount the cover grip (Standard type/Ring type) in the back of the main body. B. After mounting it, slide it until you hear the clicking sound. Cover Grip Sliding Grip 7. How to separate the cover grip A. Press the part of the cover grip (Standard type/Ring type) and slide it to separate it. Push Sliding Grip 8. Control (Operation) display. A. If you press the Power button, you can hear the voice guide and see p on the B. Short press (for less than 1 sec) the Power button once to display the battery level. C. Long press (for more than 1 sec) the Decelerate button once in Standby 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. D. Press the Stop button to finish setting. E. Long press the Stop button in initial condition once to switch between manual and auto modes. F. Long press the inject button once in initial condition to remove bubbles from the needle and enter standby mode. G. After finishing injection, initialization will be in progress automatically. H. Press the Stop button during injection to stop injection.
-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 speed.
- Vous ne pouvez rgler la voix qu'aprs l'initialisation.
- Il n'est pas possible d'liminer compltement les bulles de l'ample selon le fabricant. Alors, appuyez sur le bouton Injecter pour vrifier visuellement si les bulles sont compltement limines la vitesse de niveau 1. 9. Manual mode A. After removing bubbles, short press the Inject button in Standby mode. Injection will NOTICE AVIS start at level 1 speed and the speed will go up gradually if you repeat the step. B. When injection is complete, initialization will take place automatically after 3 seconds. C. Short press the Decelerate button during injection for gradual deceleration. (Ex: Level 3 Level 2 Level 1) D. Short press the Stop button during injection to stop injection. When stopped, short press the Inject button to resume injection at level 1 speed. 10. Auto mode with auto injection. A. After removing bubbles, short press the Inject button in Standby mode to proceed B. 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. C. When injection is complete, initialization will take place automatically after 3 seconds. D. Short press the Inject or Decelerate button during injection to switch to manual mode temporarily. The speed during auto injection will go up or down by one level and once initialization is done, it will switch to automatic mode. E. Short press the Stop button during injection to stop injection. When stopped, short press the Inject button to resume injection at the level that it was previously stopped. 11. Auto power off A. If you dont operate it for 5 minutes, then the power will be automatically turned off to prevent energy wastes or inadequate malfunctions. 12. Amount of injection and injection pressure displays A. The LED displays the amount of injection and the injection pressure. B. The amount of injection is displayed in 4 levels. (One step of LED is 25%) Each time it is increased, one more LED level will be lit and you will hear the beeping sound. C. 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. 05. Finished Use and Product Separation 1. Power off 2. Cartridge separation wash the cartridge.
-After using the device, long press the Power button to turn off the power.
-Separate the ample and the needle. Separate the cartridge from the main body and 06. How to Store and Manage the Product after Use 1. Storage A. Make sure to charge it in the cradle after use. B. When you dont charge or use the cartridge, keep it in a separate location. C. Store it at the room temperature with no direct sunlight. D. 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. 2. Washing A. 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. B. Do not let alien substance such as detergent or water enter the inside. C. Make sure to sterilize the cartridge before use.
-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 hands. WARNING ATTENTION
- N'essuyez jamais le corps principal avec un solvant tel qu'un acide fort ou du benzne.
- N'utilisez pas le corps principal avec les mains mouilles ou pollues.
-Refrain yourself from wiping off the main body with wet cotton or cloth because it can
- vitez d'essuyer le corps principal avec du coton ou un chiffon humide car cela peut CAUTION cause electrical leakages. AVERTIR provoquer des fuites lectriques. 3. Sterilization method A. Sterilization item: Cartridge only. B. You are recommended 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. ATTENTION l'quipement de l'autoclave. CAUTION
- N'effectuez pas d'autoclavage sur le corps principal ou le berceau.
- N'essuyez jamais le corps principal avec un solvant tel qu'un acide fort ou du benzne.
- Si vous effectuez un autoclavage avec l'appareil contenant du liquide, cela peut dcolorer la surface ou affecter les pices internes. Assurez-vous que le liquide ne pntre pas dans
-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. AVERTIR
- Assurez-vous de le stocker dans un endroit sans effets nfastes de la pression atmosphrique, de la temprature, de l'humidit, de la circulation de l'air, de la lumire du soleil, de la poussire, du sel ou des soufres, etc.
- Soyez prudent lorsque vous le touchez juste aprs la strilisation car il est trs chaud. A. To guarantee accurate functionalities, you are recommended to inspect the device at 4. Repair and Inspection least once a year. B. Ask the seller to inspect it. 07. 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 problem repeatedly, then it means that the main body circuit or battery has a problem, so ask your seller to repair it. 08. Troubleshooting 1. If the main body is not powered up even after you press the power on/off switch A. If the battery is discharged or if the main body is left unused for a long time without Charge the battery for use and if the power supply is still failed, then replace the charging battery. B. If the internal fuse is burned out Ask the seller to repair it. 2. If the battery does not get charged A. If the battery temperature is high or low 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. B. If the main body is not correctly mounted in the cradle Insert the main body correctly into the cradle slot. C. If the AC adaptor mounted in the cradle is not the one provided in the package 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. 3. If it is powered off during operation A. If the battery is discharged Use it after the battery is fully charged. B. If it is overloaded 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. Please, discard it according to the laws and regulation of your country. If there is some 09. Product Disposal 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 function. Therefore, RF emission level is low and it does not cause any interferences with the neighboring The product generates RF energy only for its internal electronic devices. The product is suitable for use in a facility that is directly RF emission CISPR11 Class B connected to the low voltage power supply network that supplies power to household facilities or household buildings. Harmonics emission Not IEC61000-3-2 applicable Voltage change/flicker Not applicable emission IEC61000-3-3
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 Electrostatic
(2,4,6) 8kV contact
(2,4,6) 8kV contact The floor should be discharge(ESD) IEC61000-4-2
(2,4,8) 15kV air
(2,4,8)15kV air concrete or ceramic environment - guide made of wood, tile. If the floor is covered with synthetic materials, then relative humidity should be at least 30%. Magnetic field of the power supply frequency should be ideally at the level of typical commercial use or hospital. Quick instantaneous For 2kV power For 2kV power Power quality should transient effect/burst cables cables be ideally at the level IEC61000-4-4 For 1kV input/output For 1kV input/output of commercial use or power cables power cables hospital. Surge 1kV line-to-line 1kV line-to-line IEC61000-4-5 2kV line-to-ground 2kV line-to-ground Power supply 30A/m 30A/m frequencys magnetic field IEC61000-4-8 Voltage drop and
<5% Ut with 0.5 cycles
<5% Ut 0.5 cycles Power quality should instantaneous
(Ut voltage dropped
(Ut voltage dropped be ideally at the level blackout and voltage to >95%) to >95%) of commercial use or change
<40% Ut 5 cycles
<40% Ut 5 cycles hospital. IEC61000-4-11
(Ut voltage dropped
(Ut voltage dropped If a user needs to >60%) to >60%) continuous power
<70% Ut 25 cycles
<70% Ut 25 cycles supply in case of
(Ut voltage dropped
(Ut voltage dropped blackout, then use of to >30%) to >30%) UPS or battery is
<5% Ut with 5
<5% Ut with 5 recommended. seconds seconds
(Ut voltage dropped
(Ut voltage dropped to >95%) to >95%) 3Vrms Conductive RF 3Vrms If you use a mobile or electromagnetic field 150kHz to 80MHz IEC61000-4-6 3V/m 3V/m Radiative RF 80MHz to 2.7GHz electromagnetic field IEC61000-4-3 portable RF wireless communication device, then make sure to maintain separation greater the the than 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 to 2.5GHz d = 2.3 P 800MHz 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. RF wireless devices. Guides and declaration by the manufacturer Recommended separation of a mobile or portable 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 Separation by transmitter frequency (m) power of transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz d = 1.2 P d = 1.2 P d = 2.3 P 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 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. structures, objects or humans. 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 10. 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 a. Needle b. Ample 4. Battery : 3.7V 500mAh, Li-polymer 5. Adapter 6. Steam Sterilization a. Type : Pre-vacuum b. Temperature : 121 c. Time : 15 min d. Limit of number : 100 cycle a. Rated input voltage: 100 240V AC, 1A, 50/60Hz b. Rated output voltage: 5V DC 2A SlowJec plus 1 year from the date of purchasing the main body (except for consumables) Month Date , 20( ) DSD-PLA-0100 Marked after registration is granted. 11. Product Warranty Product name Warranty period Date of purchase Model name Manufacturing number Item license number Seller repair service. installation Customer Name Telephone number Address If the malfunction is caused by the negligence of a user, then they will be charged for the
- 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
- 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. FCC Interference Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to correct 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. FCC Caution 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.
| 1 2 | Label Location | ID Label/Location Info | 95.97 KiB | July 06 2022 |
ual SN cof]
OSSTEM IMPLANT Co, Ltd. Chair Business 192, Heebong-o,Danwongu, Ansansi, ROMY Gyeonggi-do, 15428 Korea Tel +82-2-2016-7000/ Fax: +82-2-2016-7001 tpn osstem.com/manindexo UDI Device Name : Cradle(Model : DSD-PLA.0100) Rated Input : SV DC 24 DEUTSCHE OSSTEM GmbHt Mergenthalerallee 35-37, 65760 Eshborn, Germany Tot +49.6196-777-5500 / Fax : +49-6196-777-5529 FCC ID : 2ASB7PLA-O100
| 1 2 | Confidentiality Letter | Cover Letter(s) | 114.99 KiB | July 06 2022 |
OSTTEM IMPLANT Co., Ltd. Chair Business 192, Haebong-ro Danwon-gu, Ansan-si, Gyeonggi-do, Korea Tel: +82-70-4626-0882, Fax: +82-2-830-6733 Date: June 07, 2022 Federal Communications Commission Authorization and Evaluation Division Confidentiality Request regarding application for certification of FCC ID: 2ASB7PLA-0100C Pursuant to Sections 0.457 and 0.459 of the Commissions Rules, we hereby request confidential treatment of information accompanying this application as outlined below:
PERMANENT Exhibit Type Part List Schematics Diagram(s) Operation description Block diagram File Name DSD-PLA-0100C_Part List.pdf DSD-PLA-0100C _Schematics.pdf DSD-PLA-0100C _Operational Description.pdf DSD-PLA-0100C _Block diagram.pdf And the above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, Principal Research Engineer / JumYeon, Cho OSSTEM IMPLANT Co., Ltd. Chair Business
| 1 2 | LOA Letter | Cover Letter(s) | 170.16 KiB | July 06 2022 |
OSTTEM IMPLANT Co., Ltd. Chair Business 192, Haebong-ro Danwon-gu, Ansan-si, Gyeonggi-do, Korea Tel: +82-70-4626-0882, Fax: +82-2-830-6733 Date: June 7, 2022 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 FCC ID : 2ASB7PLA-0100C To whom it may concern:
I, the undersigned, hereby authorize Young-Jin, Lee of KES Co., Ltd. and hereafter referred to as KES Co., Ltd., to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by Young-Jin, Lee of KES Co., Ltd. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing KES Co., Ltd. as our agent, we still recognize that we are responsible to:
a) b) c) d) e) f) g) comply with the relevant provisions of the certification program;
make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints;
make claims regarding certification only in respect of the scope for which certification has been granted;
do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized;
upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division;
use certification only to indicate the products are certified as being in conformity with specified standards;
endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner;
OSTTEM IMPLANT Co., Ltd. Chair Business 192, Haebong-ro Danwon-gu, Ansan-si, Gyeonggi-do, Korea Tel: +82-70-4626-0882, Fax: +82-2-830-6733 ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division;
keep a record of all complaints made known to the us relating to the products compliance with requirements of the relevant standard and to make these records available to the Certification Division when requested;
take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification;
h) i) j) k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Principal Research Engineer / JunYeon, Cho OSSTEM IMPLANT Co., Ltd. Chair Business REMARK:
1. This authorization letter will be sent along with your application when filing with the Certification Division. Please follow the format and type it on company letterhead and send original to us. 2. 3. Authorized signature must be in agreement with grantee code contact in FCC database.
| 1 2 | Pre-Approval Guidance Letter | Cover Letter(s) | 58.31 KiB | July 06 2022 |
OSTTEM IMPLANT Co., Ltd. Chair Business 192, Haebong-ro Danwon-gu, Ansan-si, Gyeonggi-do, Korea Tel: +82-70-4626-0882, Fax: +82-2-830-6733 Equipment Approval Considerations item 5.b) of KDB 680106 D01 v03. regarding application for certification of FCC ID: DSD-PLA-0100C a) Power transfer frequency is less that 1 .
- The device operates at a frequency of 234 . b) Output power from each primary coil is less than or equal to 15 watts.
- Output power from each primary coil : 5 watts. c) The transfer system includes only single primary and secondary coils. This includes charging systems that may have multiple primary coils and clients that are able to detect and allow coupling only between individual pairs of coils.
- The transfer system including a charging system with single coil. d) Client device is placed directly in contact with the transmitter.
- Client device is placed directly. e) Mobile exposure conditions only (portable exposure conditions are not covered by this exclusion).
- The device is not a mobile device. f) The aggregate H-field strengths at 15 surrounding the device and 20 above the top surface from all simultaneous transmitting coils are demonstrated to be less than 50 % of the MPE limit.
- Refer to following test results. The EUT H-Field Strength levels at 15 < 50 % of the MPE H-Field Strength limit 1.63 A/m 0.340 A/m (Max) < 0.815 A/m
| frequency | equipment class | purpose | ||
|---|---|---|---|---|
| 1 | 2022-07-06 | 0.234 ~ 0.234 | DCD - Part 15 Low Power Transmitter Below 1705 kHz | Original Equipment |
| 2 | JAB - Part 15 Class B Digital Device |
| app s | Applicant Information | |||||
|---|---|---|---|---|---|---|
| 1 2 | Effective |
2022-07-06
|
||||
| 1 2 | Applicant's complete, legal business name |
OSSTEM IMPLANT Co., Ltd.
|
||||
| 1 2 | FCC Registration Number (FRN) |
0028122265
|
||||
| 1 2 | Physical Address |
192, Haebong-ro, Danwon-gu, Ansan-si
|
||||
| 1 2 |
Gyeonggi-do, N/A 15428
|
|||||
| 1 2 |
South Korea
|
|||||
| app s | TCB Information | |||||
| 1 2 | TCB Application Email Address |
t******@timcoengr.com
|
||||
| 1 2 | TCB Scope |
A1: Low Power Transmitters below 1 GHz (except Spread Spectrum), Unintentional Radiators, EAS (Part 11) & Consumer ISM devices
|
||||
| app s | FCC ID | |||||
| 1 2 | Grantee Code |
2ASB7
|
||||
| 1 2 | Equipment Product Code |
PLA-0100C
|
||||
| app s | Person at the applicant's address to receive grant or for contact | |||||
| 1 2 | Name |
J****** C******
|
||||
| 1 2 | Title |
Regulatory Affairs Team Manager
|
||||
| 1 2 | Telephone Number |
+82-2********
|
||||
| 1 2 | Fax Number |
+82-2********
|
||||
| 1 2 |
o******@osstem.com
|
|||||
| app s | Technical Contact | |||||
| n/a | ||||||
| app s | Non Technical Contact | |||||
| n/a | ||||||
| app s | Confidentiality (long or short term) | |||||
| 1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
| 1 2 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 01/02/2023 | ||||
| if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
| app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
| 1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
| 1 2 | Equipment Class | DCD - Part 15 Low Power Transmitter Below 1705 kHz | ||||
| 1 2 | JAB - Part 15 Class B Digital Device | |||||
| 1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | SlowJec plus (CRADLE) | ||||
| 1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
| 1 2 | Modular Equipment Type | Does not apply | ||||
| 1 2 | Purpose / Application is for | Original Equipment | ||||
| 1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | Yes | ||||
| 1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
| 1 2 | Grant Comments | Output Power listed is the maximum conducted output power. This device must be installed and operated so as to provide a separation distance of at least 20 cm from all persons and must not be co-located or operating in conjunction with any other antenna or transmitter, except in accordance with FCC multi-transmitter product procedures, or as evaluated in this filing | ||||
| 1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
| 1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
| app s | Test Firm Name and Contact Information | |||||
| 1 2 | Firm Name |
KES Co., Ltd
|
||||
| 1 2 | Name |
I**** R****
|
||||
| 1 2 | Telephone Number |
82-31********
|
||||
| 1 2 | Fax Number |
82-31********
|
||||
| 1 2 |
k******@kes.co.kr
|
|||||
| Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 1 | 1 | 15C | CC | 0.23400000 | 0.23400000 | ||||||||||||||||||||||||||||||||||||
| Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
| 2 | 1 | 15B | CC | ||||||||||||||||||||||||||||||||||||||
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC