Woodpecker i-Sensor H2 Digital X-Ray FDA Cleared Professional

The Woodpecker i-Sensor H2 is an FDA-cleared Class II digital dental radiography sensor designed for professional dental imaging. This CMOS-based sensor delivers high-resolution digital X-ray images for dental diagnostic procedures.

Professional Use Only: Federal law restricts this device to sale by or on the order of a licensed dentist. Intended for use by trained dental professionals in clinical settings.

Advanced Technology: Features ultra-thin 4.4mm profile, IP68 protection rating, and 25 lp/mm resolution for exceptional diagnostic image quality.

FDA Disclaimer: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Key Features

1. CMOS sensor technology with 25 lp/mm resolution
2. Ultra-thin 4.4mm profile for patient comfort
3. IP68 rated: dustproof and waterproof
4. Tested for 80,000+ cable bending cycles
5. Compatible with standard dental X-ray systems
6. Includes professional imaging software
7. Unlimited user licenses

Intended Use

FDA-Cleared Indication:

1. This device is intended for capturing intraoral digital radiographic images for dental diagnostic purposes by licensed dental professionals.

Clinical Applications:

1. Bitewing radiography
2. Periapical imaging
3. Endodontic procedures
4. General dental diagnostic imaging

Intended Users:

1. Licensed dentists (DDS/DMD)
2. Dental specialists
3. Trained dental personnel under professional supervision

Directions for Use

Installation:

1. Install by qualified dental equipment technician
2. Connect to FDA-compliant dental X-ray generator
3. Install Woodpecker imaging software
4. Calibrate per manufacturer specifications

Clinical Use:

1. Place sensor in sterile barrier sleeve
2. Position sensor intraorally using appropriate technique
3. Align X-ray beam per standard protocols
4. Activate exposure following ALARA principles
5. Review captured image
6. Remove and disinfect sensor per infection control protocols

Professional training in dental radiography required.

Safety Information

Professional Use Only:

1. Restricted to licensed dental professionals
2. Requires radiation safety training
3. Must comply with state radiation control regulations
4. Follow infection control protocols

Radiation Safety:

1. Use with FDA-compliant X-ray generators only
2. Follow ALARA (As Low As Reasonably Achievable) principles
3. Proper patient shielding required
4. Operator training mandatory

Infection Control:

1. Use disposable barrier sleeves for each patient
2. Disinfect per CDC guidelines between patients
3. Do not autoclave sensor
4. Follow manufacturer cleaning instructions

Device Care:

1. Handle with care to avoid damage
2. Inspect before each use
3. Store in protective case
4. Professional service only

Disclaimer

This is an FDA-cleared Class II medical device for professional dental radiographic imaging. Intended for use by licensed dental professionals only. Federal law restricts this device to sale by or on the order of a licensed dentist. Not for consumer use.

1. Who is eligible to purchase this device?

Answer: Licensed dentists (DDS/DMD), dental specialists, dental clinics, hospitals with dental departments, dental schools, and authorized medical equipment distributors.

2. Who can purchase this device?

Answer: Licensed dental professionals, dental clinics, hospitals, and authorized medical equipment distributors. Proof of professional license may be required.

3. Can I use this for home dental care?

Answer: No. This is professional medical equipment restricted to use by licensed dental professionals in clinical settings only.

4. What training is required?

Answer: Users must be licensed dental professionals with training in dental radiography, radiation safety, and infection control protocols.

5. What X-ray systems is this compatible with?

Answer: Compatible with standard dental X-ray generators. Contact manufacturer for specific compatibility verification.

6. Does this require professional installation?

Answer: Yes. Installation by qualified dental equipment technicians is required for proper setup and safety compliance.

7. Are there radiation safety requirements?

Answer: Yes. Users must comply with federal and state radiation safety regulations, including training, registration, and ALARA principles.

8. How is infection control maintained?

Answer: Use disposable barrier sleeves for each patient and disinfect sensor between uses per CDC and manufacturer guidelines. Do not autoclave.

9. Can I trade in my old sensor?

Answer: Some distributors offer trade-in programs for old dental sensors. Contact your supplier for trade-in policies and values.

10. Where can I get technical support?

Answer: Contact Woodpecker technical support at [contact information] or your authorized distributor.