PRP-startset | EBA 200
PRP startersset bestaande uit:
1x Hettich EBA 200 centrifuge
2x PRP buisjes | Vi PRP-Pro PU 10 st.
1x KIPIC® naald 25G x 42mm, PU 100 st.
1x KIPIC® Mesotherapie naald 30G 4mm | PU 100 st.
1x KIPIC® Mesotherapie naald 32Gx4mm | PU 100 st.
1x Mediware wegwerpspuiten 5ml 3-delig Luer-Lock steriel (PU 100 st.)
1x Safety Bloedafname Set + Luer Adapter 21G - PU 35 st.
1x Mediware wegwerpspuiten 2/3ml 3-delig Luer-Lock steriel (PU 100 st.)
1x PRP-serumcrème voor PRP
PRPmed.de: Uw expert in PRP-technologie
In de wereld van de esthetische geneeskunde winnen behandelingen met bloedplaatjesrijk plasma (PRP) steeds meer aan populariteit. PRPmed.de is uw betrouwbare partner als het gaat om hoogwaardige PRP-producten en -technologieën. Maar wat is PRP precies, waarom is het zo gewild en hoe kan PRPmed.de u optimaal ondersteunen?
Wat is PRP?
PRP staat voor bloedplaatjesrijk plasma – een innovatieve behandelmethode waarbij het eigen bloed van de patiënt wordt gebruikt om de regeneratie van de huid te bevorderen. De toepassingen zijn veelzijdig: PRP kan zowel voor huidverjonging als voor haarherstel worden gebruikt. Deze natuurlijke behandelmethode wint aan populariteit vanwege de effectiviteit en minimale bijwerkingen.
PRPmed.de: Uw specialist in PRP-technologie
PRPmed.de is uw professionele online winkel, gespecialiseerd in PRP-technologie. Of u nu arts, natuurgeneeskundige of een professional in de medische esthetiek bent, wij bieden een breed scala aan PRP-producten die zijn afgestemd op uw specifieke behoeften.
Onze topproducten
Een van onze topproducten is de VI - PRP-PRO PRP-buis, ontworpen voor de veilige en effectieve bereiding van PRP. Daarnaast bieden wij een innovatieve regeneratieve PRP-crème aan, die gecombineerd kan worden met het eigen plasma van de patiënt om celvernieuwing en huidregeneratie te bevorderen.
Waarom kiezen voor PRPmed.de?
Naast ons uitgebreide assortiment PRP-producten staan wij voor uitmuntende kwaliteit en expertise. Onze KIPIC® injectienaalden zijn bijvoorbeeld ideaal voor mesotherapie, botulinumtoxine-injecties en vele andere toepassingen. Bij PRPmed.de kiest u voor producten die voldoen aan de hoogste medische normen.
Veiligheid en klantenservice
Uw veiligheid is onze hoogste prioriteit. Daarom bieden wij uitsluitend medische apparaten van Risicoklasse IIa + b, die zorgen voor een wettelijk veilige toepassing. Daarnaast ondersteunen wij professionals met gespecialiseerde PRP-trainingen, waarmee u uw kennis en vaardigheden binnen de esthetische geneeskunde kunt uitbreiden. Ons deskundige klantenteam staat altijd voor u klaar om u te helpen bij het kiezen van de juiste producten.
Conclusie
Of u nu een ervaren beoefenaar bent of nieuw in de wereld van PRP-technologie, PRPmed.de is uw betrouwbare partner. Met een breed scala aan producten, de hoogste kwaliteit, diepgaande expertise en uitstekende klantenservice, zijn wij de online winkel van uw keuze voor al uw PRP-gerelateerde behandelingen.
GPSR – General Product Safety Regulation
Responsible Economic Operator according to GPSR:
prpmed Funkner e.K.
Kurstraße 7
63667 Nidda
Germany
Phone: +49 6043 9862 817
Email: kontakt@prpmed.de
Detailed GPSR Safety Regulations for the PRP Starter Set EBA 200
The PRP Starter Set EBA 200 is a medical device specifically designed for professional use in laboratory environments. It complies with the General Product Safety Regulation (GPSR), which governs product safety within the EU. To ensure the safety of users and patients, the following safety regulations must be strictly observed. These regulations cover the entire lifecycle of the device – from installation and operation to maintenance and disposal.
1. General Safety Requirements
-
Restricted Use by Qualified Personnel:
- This product is intended exclusively for use by trained and qualified professionals. Unauthorized or untrained individuals are not permitted to operate or maintain the device.
- The sale is restricted to professionals or their authorized purchasers in accordance with legal requirements for medical devices.
-
Compliance with Legal Standards:
- Users must adhere to national and European regulations for medical devices. In Germany, this includes the Medical Devices Act (MPG) and the Medical Device Operator Ordinance (MPBetreibV).
- Correct use is mandatory to minimize risks to both patients and operators.
-
Product Liability:
- The manufacturer is not liable for damages resulting from improper use, failure to follow safety instructions, or unauthorized modifications to the device.
-
Markings and Documentation:
- Ensure the device is marked with the CE certification, confirming compliance with all relevant EU directives.
- Keep the user manual and all related documentation readily available and follow all instructions.
2. Safety Regulations for Installation
-
Choosing the Installation Location:
- Place the EBA 200 on a stable, level, and vibration-free surface.
- The location must be free from direct sunlight, humidity, dust, and exposure to chemical fumes.
-
Electrical Safety:
- The device should only be connected to a grounded outlet that meets local electrical standards (e.g., DIN VDE standards in Germany).
- Do not use damaged cables, outlets, or extension cords. Replace any damaged cables immediately.
-
Environmental Conditions:
- The device is designed to operate in a temperature range of 10°C to 40°C.
- The relative humidity should be below 80%. Avoid exposing the device to extreme temperature fluctuations or condensation, as these can impair its performance.
3. Safety Regulations During Operation
-
Training and Instruction:
- Before first use, all personnel must undergo comprehensive training or instruction on how to operate the device.
- The user manual must be read and followed in its entirety.
-
Personal Protective Equipment (PPE):
- Always wear appropriate PPE, such as laboratory coats, protective goggles, and sterile gloves, to prevent contact with biological materials or hazardous substances.
-
Loading the Centrifuge:
- Ensure the centrifuge is symmetrically loaded to avoid imbalance during operation. Improper loading can cause vibrations, damage, or malfunctions.
- Only use approved tubes or containers that are compatible with the centrifuge.
-
Lid Safety:
- Before starting the device, the centrifuge lid must be fully closed and locked. Never operate the device if the lid is not properly secured.
-
Monitoring Operation:
- Do not leave the device unattended while it is running. If you notice unusual sounds, vibrations, or error messages, stop the device immediately and investigate the issue.
-
Emergency Stop Function:
- Familiarize yourself with the emergency stop function of the device to respond quickly in the event of a malfunction.
4. Maintenance and Cleaning
-
Regular Maintenance:
- Regular maintenance must be performed according to the manufacturer's guidelines. This includes inspections of:
- The lid seal and locking mechanism.
- The condition of mechanical and electrical components.
- Only qualified personnel should perform maintenance tasks.
- Regular maintenance must be performed according to the manufacturer's guidelines. This includes inspections of:
-
Cleaning:
- Clean the device after each use with appropriate medical-grade disinfectants approved for use with biological materials.
- Avoid harsh cleaning agents that may damage the device’s surface.
- Ensure no liquids enter the electronic components of the device.
-
Calibration:
- The device must be calibrated regularly to ensure precise performance. Calibration should only be done by authorized technicians or the manufacturer.
5. Safety Regulations for Disposal
-
Battery Disposal:
- If the device contains batteries or rechargeable cells, dispose of them in accordance with local waste management regulations for batteries. Use designated collection points.
-
Device Disposal:
- Medical devices, such as the PRP Starter Set EBA 200, are subject to specific disposal regulations. The device must not be disposed of with regular household waste.
- Contact the manufacturer or a certified waste disposal service provider to ensure proper disposal in compliance with legal requirements.
6. Emergency Procedures
-
Power Outage:
- In the event of a power outage during operation, immediately switch off the device and unplug it. Wait a few minutes after power is restored before restarting the device.
-
Accidents with Biological Materials:
- If biological samples are spilled or come into contact with surfaces, clean and disinfect the affected areas immediately. Always wear protective equipment while handling biological materials.
- Report any accidents according to your institution's internal protocols.
-
Technical Malfunctions:
- If the device malfunctions, such as emitting unusual noises or vibrations, switch it off immediately and unplug it. Contact the manufacturer or the customer service team for assistance.
7. Contact Information for Questions or Issues
For questions regarding operation, maintenance, or disposal of the PRP Starter Set EBA 200, please contact:
PRPMed
Kurstraße 7
63667 Nidda
Germany
Phone: +49 6043 9862 817
Email: kontakt@prpmed.de
Important Note: These safety regulations are developed in accordance with the General Product Safety Regulation (GPSR). Compliance with these regulations is mandatory to ensure the safety of both users and patients. For users outside the EU, please refer to the applicable regional safety regulations.