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Correa rotuliana inteligente ORION PRO
Manual del usuario y guía de seguridad
Este producto no es un dispositivo médico. Todos los datos de movimiento y presión son únicamente para referencia de bienestar general.
- Antes de Empezar — Advertencias de Seguridad
- Guía rápida de 3 pasos para empezar
- Guía de uso correcto
- Controles y luces de estado LED
- Resumen completo de las funciones de la aplicación XTAND
- Uso seguro para deportes y actividades diarias
- Reglas de limpieza, almacenamiento y viajes
- Condiciones Anormales y Respuesta de Emergencia
- Solución de problemas comunes
- Información sobre eliminación, reciclaje y medio ambiente
- Especificaciones y Cumplimiento Normativo
- Garantía, soporte y apéndices
Antes de empezar — Advertencias de seguridad críticas
ADVERTENCIA: Leer completamente antes de usar o cargar
Símbolos de seguridad y palabras de advertencia
| Palabra de advertencia | Significado |
|---|---|
| PELIGRO | Indica una situación peligrosa que, si no se evita, provocará la muerte o lesiones graves. Se utiliza únicamente para peligros extremos inmediatos. |
| ADVERTENCIA | Indica una situación peligrosa que, si no se evita, podría provocar la muerte o lesiones graves. |
| PRECAUCIÓN | Indica una situación peligrosa que, si no se evita, podría provocar lesiones leves o moderadas. |
| AVISO | Indica información relacionada con daños en el producto, pérdida de datos, funcionamiento correcto o cumplimiento normativo, en lugar de lesiones personales. |
No es un dispositivo médico
El XTAND Orion Pro y la aplicación complementaria XTAND no son dispositivos médicos. No pueden diagnosticar, tratar, curar o prevenir lesiones, enfermedades o afecciones articulares. Las métricas en tiempo real de presión, impacto, marcha y calorías son solo valores estimados y nunca deben utilizarse para la toma de decisiones médicas o de emergencia.
Descripción general del producto — Cómo funciona
El producto utiliza sensores y algoritmos de software para identificar patrones de movimiento y ajustar la presión neumática dentro del rango configurado. El rendimiento real de reconocimiento y soporte varía según el ajuste, la anatomía del usuario, la actividad, la ropa, las condiciones ambientales, el firmware y el uso adecuado.
El producto no garantiza la prevención de lesiones, el equilibrio, la prevención de caídas ni un resultado atlético en particular.
Uso previsto
ORION PRO es un producto de soporte ponible para el consumidor destinado a proporcionar compresión mecánica ajustable y soporte alrededor de la región rotuliana durante la marcha ordinaria, la carrera, el uso de escaleras, las actividades de acondicionamiento físico y el movimiento diario, dentro de las limitaciones de este manual. Está destinado para uso personal por parte de un usuario que pueda entender las instrucciones, comunicar las molestias y quitarse el producto sin demora.
Quiénes no deben usar el producto
ADVERTENCIA: Consulte a un profesional de la salud antes de usar
No usar en o cerca de:
- Heridas abiertas, úlceras o incisiones quirúrgicas
- Piel infectada, inflamada, quemada, con ampollas o exudativa
- Eczema grave, dermatitis alérgica o sarpullido activo
- Áreas con sensación ausente o significativamente reducida
- Áreas con inflamación inexplicada, decoloración o dolor intenso
- Una extremidad con sospecha de coágulo sanguíneo, compromiso vascular agudo o hemorragia no controlada
Suspenda su uso y busque atención médica si se presentan síntomas.
Niños y usuarios vulnerables
Este producto no es un juguete. Mantenga el dispositivo, el cable de carga, el embalaje y los componentes pequeños fuera del alcance de los niños pequeños. Un usuario menor o vulnerable puede utilizar el producto únicamente bajo la supervisión continua de un adulto responsable que pueda comprobar el ajuste, el estado de la piel y la circulación, y que pueda retirar el dispositivo inmediatamente.
Uso prohibido y previsible
- Utilice el dispositivo mientras se carga.
- Úsalo como equipo de protección para trabajos en altura, escalada, motociclismo, esquí, deportes de combate/contacto, deportes acuáticos o cualquier actividad donde el fallo del producto pueda provocar lesiones graves.
- Úsalo para seguir haciendo ejercicio a pesar del dolor, el entumecimiento, la inestabilidad o la lesión.
- Úsalo mientras duermes, estás inconsciente, intoxicado o no puedes quitarte el dispositivo de forma independiente.
- Úsalo en otra parte del cuerpo.
- Combínelo con órtesis, productos de compresión, almohadillas térmicas, estimuladores eléctricos o dispositivos médicos a menos que lo apruebe un clínico calificado y XTAND.
- Modificar, perforar, aplastar, doblar, abrir o reparar el módulo electrónico o el sistema de aire.
Empiece en 3 sencillos pasos
Complete el desempaquetado, la carga y la vinculación con la aplicación antes de usarlo por primera vez.
Paso 1: Desempaquetado e inspección completa
- Cuerpo principal de la rodillera rotuliana Orion Pro
- Módulo de computación inteligente de IA extraíble
- Correa de ajuste de extensión
- Cable de carga USB Tipo-C
- Manual del usuario oficial y guía de seguridad
Paso 2: Cargar completamente el módulo de IA
- Desconectar el módulo de IA de la válvula de aire de la correa
- Conecte el cable Tipo C al puerto de carga inferior
- Conectar a una fuente de alimentación USB de 5V CC certificada
- Carga completa: ~60 minutos; LED verde fijo = carga completa
- Duración de la batería: 4-6 horas de uso continuo
Paso 3: Vincular la aplicación XTAND y el dispositivo
- Descarga la aplicación oficial de XTAND desde la App Store / Google Play
- Activar Bluetooth, registrarse e iniciar sesión en la cuenta
- Mantén presionado el botón del módulo durante 3 segundos para encender (parpadeo rápido naranja)
- Aplicación: Yo → Dispositivo → Añadir dispositivo → Conectar XTAND-Orion-G1
Rango de ajusteCircunferencia de pierna compatible: 34 cm – 45 cm. No fuerce el ajuste en piernas fuera de este rango.
Inspección de paquetesInspeccione el paquete inmediatamente. No utilice el producto si falta algún artículo, o si está agrietado, deformado, mojado, hinchado o dañado de cualquier otra forma.
TrazabilidadNúmero de serie/lote: Véase la etiqueta o el embalaje del producto. El número de serie o de lote debe permanecer legible para fines de trazabilidad, garantía e investigaciones de seguridad.
Antes del primer uso — Inspección inicial
- Confirme que el modelo y el paquete son correctos.
- Inspecciona el módulo, la correa, la válvula, la hebilla, el cable y el puerto de carga.
- No utilizar si hay agrietamiento, deformación, hinchazón, fugas, corrosión, cableado expuesto, olor extraño, entrada de agua o un componente suelto.
- Confirme que el producto esté seco y a temperatura ambiente.
- Cargue completamente bajo supervisión utilizando una fuente de alimentación certificada y compatible.
- Descargue la aplicación oficial de XTAND únicamente desde una tienda de aplicaciones autorizada.
- Lea todas las advertencias de seguridad antes de usar.

Lleva Orion Pro correctamente

Asamblea
- Confirme que el módulo y la válvula estén limpios, secos y sin daños.
- Alinee la salida de aire del módulo con la válvula de aire de la correa.
- Presione de manera uniforme hasta que encaje por completo. No tuerza, golpee ni fuerce el módulo.
- Encienda y confirme el indicador de inicio normal. Si el inicio falla, apague, retire el módulo y repita el montaje.
- No lo utilice si el módulo está flojo o si la válvula presenta fugas.
- Place the strap: Position the strap approximately 3–5 cm below the kneecap, with the logo facing forward.
- AI module position: Position the AI computing module on the outer side of the knee.
- Secure the buckle: Thread and secure the buckle.
- Adjust fit: Adjust until snug but not tight. You should be able to insert one finger under the strap without force.
- Power on: Power on by pressing and holding the button for approximately 3 seconds.
- Start at low pressure: Begin at the lowest suitable pressure and reassess comfort after several minutes.
WARNING: Circulation and Pressure Injury
How to Remove
- Stop activity and stand or sit in a safe, stable place
- Press and hold the button to power off
- Wait until pressure is released
- Release the buckle and remove the strap gently
- Inspect the skin and knee area
- Remove the module before cleaning or charging
Fit Adjustments & Slipping
If the strap slips or rotates during use, stop activity and refit at the correct position. To prevent slipping, confirm size compatibility, ensure skin or under-layer fabric is dry, and secure the buckle properly. Do not use if the buckle or strap is worn or damaged.
Charging, Controls & Status Lights
DANGER: Fire, Explosion and Burn Hazard
Approved Charging Method
- Remove the AI computing module from the strap before charging.
- Place it on a stable, hard, dry, nonflammable surface with ventilation.
- Use the supplied cable or an undamaged, standards-compliant USB Type-C cable.
- Use only a certified SELV USB power source rated DC 5 V. Do not use an adapter with visible damage, loose pins or abnormal heat.
- Keep the charging port dry and free of debris.
- Connect the cable without force.
- Normal charging time is approximately 60 minutes. Disconnect when fully charged.
- Adult supervision is required when a minor uses or charges the device.
Never Charge When
- The device is being worn or used.
- The device, cable, connector or adapter is wet.
- The module is hot from exercise, direct sun or a vehicle interior. Allow it to return to room temperature first.
- The device is swollen, cracked, dropped, crushed, leaking, corroded or has an unusual odor.
- The charging connector does not fit normally.
- The device is covered by bedding, clothing, a bag or other insulating material.
- Near flammable liquids, gases, paper, bedding or other combustible materials.
- During an electrical storm or in an unsafe power environment.
Charging Supervision
Do not leave the product charging for an extended period without supervision, overnight or while you are away from the premises. Periodically check for excessive heat, smoke, odor, noise, swelling or discoloration. Disconnect immediately if any abnormality occurs.
DANGER: Smoke, Fire or Battery Failure
If the device emits smoke, sparks, flames, a strong chemical odor or rapidly increasing heat:
- Do not touch it with bare hands.
- Disconnect power only if it can be done safely.
- Move people away and call local emergency services.
- Do not inhale smoke.
- Do not reuse, ship or place the damaged device in household trash.
- Contact XTAND and follow local hazardous-battery disposal instructions.
Module Button Operation
- Power On: Hold button for 3 seconds
- Power Off: Hold button for 3 seconds (auto full air vent before removal)
- Mode & pressure tuning: Managed exclusively via XTAND App
LED Indicator Reference Table
| Device Status | LED Base Color | Light Animation |
|---|---|---|
| Charging In Progress | Red + Green | Gradient breathing flash |
| Fully Charged | Green | Solid constant on |
| Power Startup Ready | Orange | Rapid fast flashing |
| Active Intelligent Mode | White | Steady light |
| Walking Detection | Blue | Solid light |
| Running Detection | Yellow | Solid light |
| Stair Climbing Detection | Red | Solid light |
Pressure Adjustment Range
Nominal adjustable pneumatic pressure: 0 kPa – 50 kPa
- Intelligent Mode: Auto dynamic pressure tuning in 1–3 seconds based on knee flexion & impact
- Manual Mode: Fixed custom pressure set inside XTAND App
- Always start at lowest comfortable pressure; higher pressure increases circulation risk
Operating Modes
Intelligent Mode
Intelligent mode uses sensor input and software to adjust support based on detected activity. The white indicator shows that intelligent mode is active. Detection may be affected by improper fit, unusual gait, rapid transitions, loose clothing, low battery, sensor obstruction or software errors. Always remain aware of how the product feels. Do not assume the algorithm has correctly identified your activity.
Manual Mode
Manual mode applies the user-selected support setting. Begin at the lowest effective level. Higher pressure is not necessarily better and may increase discomfort or circulation risk. Do not change settings while crossing roads, using stairs or performing an unstable movement.
Pressure Comfort & Adjustment
If the pressure feels too high during use, immediately reduce the setting in the app, or power off and loosen the strap. Higher pressure is not always better and may increase discomfort. Do not continue use if you experience pain, numbness, or skin discoloration.

XTAND App Full Feature Breakdown

Main Dashboard Displays
- Real-time activity metrics: time, distance, steps, estimated calorie burn
- Live knee impact intensity & joint force readings
- Device panel: battery %, Bluetooth state, active mode, current kPa pressure
Connecting the App
- Download the official XTAND app from an authorized app store.
- Review the current privacy notice and permissions before registration.
- Turn on Bluetooth and keep the phone close to the device.
- In the app, select Me > Device > Add Device > Connect.
- Confirm that the displayed device name matches your product.
- Install firmware updates only through official XTAND channels and keep the device charged during an update.
Core App Modules
- Exercise Mode Selector: Intelligent Auto / Manual Fixed Pressure
- Workout Reports: Daily/Weekly/Monthly gait, jump impact, knee range of motion trends
- Personalized Settings: Body weight, sport goals, custom pressure alert thresholds
- Full Activity History Log: All past workout detailed records
- Firmware Update Portal: Official device upgrades only via XTAND App
WARNING: Do Not Rely on App Data for Safety or Medical Decisions
Cybersecurity and Account Safety
- Use a strong, unique password and keep your phone operating system and app updated.
- Do not share verification codes or account credentials.
- Pair only with your own device in a trusted environment.
- Remove the product from your account before resale or transfer.
- If you suspect unauthorized access, change your password, disconnect the device and contact support.
- Bluetooth interruption or app failure does not make continued physical activity safe; stop and assess the product directly.
Safe Use During Sports & Daily Activity
WARNING: Injury and Fall Risk
Standard Safe Usage Guidelines
- Warm up before exercise.
- Test the product at low intensity in a controlled environment before higher-intensity use.
- Stop if the strap slips, rotates, loosens or changes gait unexpectedly.
- Do not use when driving or operating machinery.
- Do not adjust the app or product while moving in traffic, on stairs or on uneven ground.
- Avoid sharp objects and abrasive surfaces.
- Do not use in water, while swimming, in heavy rain, in a sauna, steam room or other high-heat/high-humidity environment.
- Do not continue use if battery is low and loss of support could create a hazard.
- Take regular breaks, remove the product and inspect the skin.
Environments to Avoid Wearing Orion Pro
- Heavy rain, swimming, showers, saunas, steam rooms (device non-waterproof)
- Locked car dashboards, extended direct midday sun extreme heat
- Driving motor vehicles, industrial machinery operation, motorcycle riding
Skin Checks & Duration
During first uses, check skin after 10–15 minutes and again after use. Users with sensitive skin may wear a thin clean layer of clothing if it does not interfere with fit or sensors. Do not use over ointments, lotions or wet skin. There is no universal safe maximum duration; comfort and circulation must be checked regularly.
Cleaning, Storage & Travel Instructions
WARNING: Electric Shock, Fire and Product-Damage Risk
Fabric Strap Cleaning (DETACH AI MODULE FIRST)
- Power off and fully separate electronic AI module from air valve
- Fasten all buckles to prevent fraying or snags
- Hand wash only cool/lukewarm water with mild gentle detergent
- No bleach, alcohol, solvent cleaners, fabric softener, wringing or ironing
- Rinse all soap residue completely
- Air-dry in shaded ventilated area — no tumble dry / direct sunlight
- Reassemble module only once strap is 100% dry
AI Electronic Module Care
Wipe the exterior with a soft, dry cloth. If necessary, use a cloth very lightly dampened with water, then dry immediately. Do not allow liquid into openings. Do not use compressed air, sharp tools or conductive objects in the charging port.
Maintenance Inspection
Before use, verify:
- Strap and stitching are intact.
- Buckle locks securely.
- Valve and module seat correctly.
- Charging port is clean and dry.
- Module does not rattle or separate.
- No swelling, corrosion, cracks, exposed wires or abnormal odor.
- Firmware and app are current where required.
There are no user-serviceable internal parts. Contact XTAND for service.
Long-Term Storage Rules
- Power off, release air pressure, clean and fully dry all components
- Store cool, dry, ventilated; away from heaters, flame, direct sunlight
- Storage temperature range: 0°C – 45°C
- Do not stack heavy objects on device; separate from metal short-circuit risks
- Recharge module to 50% battery every 30 days for multi-week storage
Transport and Air Travel
Protect the module from impact, crushing, moisture and extreme temperature. Do not ship a damaged, swollen, recalled or thermally affected lithium-battery product through ordinary mail or courier channels. Follow the carrier's current dangerous-goods rules. For air travel, carry and use the product only as permitted by the airline, airport and applicable battery rules. Turn off Bluetooth and the device when instructed.
Abnormal Conditions and Emergency Response
Stop Use Immediately If
- Smoke, sparks, flame, swelling, leakage or strong odor
- Unusual or rapidly increasing heat
- Cracking, deformation, water intrusion or impact damage
- The module detaches or the strap fails
- Pressure does not release
- Unexpected continuous inflation or abnormal vibration/noise
- Numbness, tingling, coldness, discoloration, severe pain, swelling, rash or burning
- Dizziness, loss of balance or altered gait
- App or firmware behavior that could affect safe operation
Immediate Response
- Stop moving and go to a safe, stable position.
- Power off the product if safe.
- Release the buckle and remove the product. If it cannot be removed without pain or injury, seek emergency help.
- For skin or circulation symptoms, stop use and monitor. Seek urgent care for severe, persistent or worsening symptoms.
- For smoke/fire/battery failure, follow the battery emergency instructions in the Charging section.
- Do not restart, recharge, repair, ship, sell, gift or dispose of the affected device until XTAND or a competent authority provides instructions.
- Preserve the product, packaging, charger, purchase record, photographs, app screenshots and serial/batch number for investigation, unless doing so is unsafe.
Report Safety Incidents
Report any injury, burn, fire, smoke, property damage, unexpected inflation, pressure-release failure or other safety event to XTAND promptly. Include the product model, serial/batch number, purchase date, activity at the time, and a clear description. Depending on the country, consumers may also report unsafe products to the relevant market-surveillance or consumer-safety authority.
Solución de problemas comunes
| Fault Symptom | Immediate Action Steps |
|---|---|
| Device fails to power on | 1. Charge module 30+ mins with certified 5V charger
2. Re-seat module fully onto air valve
3. Stop use if swollen, wet or dropped |
| Charging light does not activate | 1. Re-seat Type-C cable both ends
2. Wipe charging port dust with dry cloth
3. Cool hot module fully before charging |
| XTAND App cannot locate device | 1. Confirm module powered on with orange flash
2. Toggle Bluetooth & grant app location permissions
3. Reboot phone + App, place phone within 30cm of module |
| Abnormal continuous auto-inflate | 1. Power off instantly
2. Detach & re-seat module flush to air valve
3. Stop reuse if air valve leaks after re-assembly |
| Pressure cannot release after power off | 1. Carefully unfasten buckle to manually vent air
2. Discontinue all use & contact XTAND Support |
| AI module overheats mid-use | 1. Power off instantly & remove from skin
2. Place on cool non-flammable surface
3. Do not recharge before support review |
Disposal, Recycling and Environmental Information
WARNING: Do Not Place Lithium-Battery Products in Fire or Ordinary Trash
Separate Collection
The crossed-out wheeled-bin symbol means the electrical product must be collected separately from unsorted municipal waste. Remove personal account data where possible and deliver the product to an authorized collection point. A damaged or thermally affected battery may require special hazardous-waste handling; contact local authorities before transport.
Material Compliance Statement
Any RoHS, REACH or hazardous-substance statement must be supported by current model-specific test reports, supplier declarations and technical documentation.
Technical Specifications & Regulatory Compliance
Orion Pro Official Spec Sheet
| Marca | XTAND |
| Model | Correa rotuliana inteligente ORION PRO |
| Total Weight | ~52g |
| Compatible Leg Circumference | 34cm – 45cm |
| Charging Input Voltage | CC 5V |
| Lithium Battery Capacity | 80mAh / 0.296Wh |
| Full Charge Time | ~60 minutes |
| Battery Runtime | 4–6 hours (mode dependent) |
| Adjustable Pressure | 0–50 kPa nominal |
| Operating Temperature | 0°C to 45°C |
| Storage Temperature | 0°C to 45°C |
| Bluetooth Version | Bluetooth 5.1 |
| Supported OS | iOS 12.0+ / Android 10.0+ |
| Water Resistance | Not waterproof |
| FCC ID | 2BOZY-R102 |
Specification Changes
Specifications and software features may change to improve safety, compliance or performance. Material changes affecting safe use will be communicated through updated labeling, manuals, the app, website or direct safety notice as appropriate. Do not rely on a superseded manual.
United States — FCC Part 15
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. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment.
European Union
Before placing the product on the EU market, the responsible economic operator must confirm the applicable legislation, conformity-assessment route, harmonized standards, Declaration of Conformity, CE marking, traceability, EU Responsible Person details, WEEE/battery obligations and required local-language instructions. For EU sales, English alone is not sufficient in every Member State. Provide instructions and safety information in the language(s) required by each destination country.
United Kingdom and Other Markets
Additional markings, responsible-person details, radio approvals, recycling registrations, privacy notices and local-language requirements may apply in the United Kingdom, Canada, Australia, Japan and other markets. Confirm market-specific requirements before sale and do not assume CE or FCC documentation covers every country.
Certification Marks
Print FCC, CE, RoHS, WEEE or other marks only when:
- The exact model and configuration are within the verified scope.
- Valid reports, certificates or declarations are available.
- The mark's size, format and accompanying information meet applicable rules.
- No material hardware, radio, battery, software or supplier change has invalidated the evidence.
Limited Warranty & Customer Support
Limited Consumer Warranty Terms
Subject to applicable mandatory consumer law, XTAND provides a limited warranty from the original retail purchase date for defects in materials and workmanship under normal intended use. The specific warranty period varies by country of sale and must match the terms offered in the country of sale. This warranty may not reduce statutory consumer rights.
Warranty coverage excludes damage caused by:
- Misuse, accident, impact, crushing, puncture, liquid intrusion or extreme temperature
- Charging with incompatible or damaged equipment
- Unauthorized modification, disassembly, repair or software alteration
- Normal wear, cosmetic damage or consumable textile deterioration
- Failure to follow instructions, cleaning or storage requirements
- Use outside the intended purpose or size range
- Products with altered or unreadable serial/batch information
- These exclusions do not apply where prohibited by law and do not exclude liability that cannot lawfully be excluded.
Service Process
Before returning a product:
- Stop use if there is any safety concern.
- Contact XTAND support and obtain return instructions.
- Do not ship a swollen, leaking, burned, overheated or otherwise damaged lithium-battery device without specific dangerous-goods instructions.
- Back up any app information you wish to keep.
- Provide proof of purchase, serial/batch number, description, photographs and incident details.
- Remove personal account pairing where safe and appropriate.
No Unlawful Limitation of Rights
Nothing in this manual excludes, restricts or modifies rights or remedies that cannot legally be excluded, restricted or modified under applicable consumer-protection or product-liability law.
How to Submit Support & Warranty Requests
- Support Email: hello@xtand.ai
- Safety Incident Portal: xtand.ai/product-safety
- Required info: model, serial/batch number, purchase date, fault photos, full issue description
- Battery fire/overheat emergency contact: security@xtand.com.cn
Manufacturer & Company Information
Legal name: Mebotx Intelligent Technology (Suzhou) Co., Ltd.
Registered address: 9/F, Building 1B, Start-up Zone, Yangtze River Delta International R&D Community, No. 286 Qinglonggang Road, High-Speed Rail New City, Xiangcheng District, Suzhou, Jiangsu, China
Correo electrónico: hello@xtand.ai
Safety incident contact: security@xtand.com.cn
Telephone: 86-0512-65109039
Website: https://xtand.ai
Return Rule: Discontinue use of malfunctioning device before return shipping. Do not ship swollen/leaking battery modules without official hazardous goods instructions from XTAND support.
Appendix A — Quick Safety Checklist
Before every use:
- ☐ Product, strap, buckle, valve and module are undamaged.
- ☐ No swelling, leakage, odor, corrosion, cracks or abnormal heat.
- ☐ Skin is clean, dry and free of wounds or active irritation.
- ☐ Size and wearing position are correct.
- ☐ Pressure starts at the lowest effective level.
- ☐ Charging is complete; the product is not connected to power while worn.
- ☐ Environment is dry, safe and free of traffic or fall hazards.
- ☐ User can remove the product immediately.
- ☐ App data is not being treated as medical or emergency information.
- ☐ Serial/batch number and support contact are available.
Appendix B — Incident Reporting Record
Use this form to record details when reporting a safety incident to XTAND:
- Reporter name
- Contact information
- País
- Product model
- Serial or batch number
- Purchase date and channel
- Incident date and local time
- Activity at the time
- App/firmware version
- Charger/cable used
- Description of event
- Injury or medical treatment
- Property damage
- Photos/videos/screenshots preserved
- Product isolated and not reused
Appendix C — Regulatory and Risk-Control Basis
Purpose
This appendix records the principal public sources used when drafting the safety structure. It is not a declaration of conformity and does not replace model-specific legal advice, testing or certification.
Reference Summary
- EU General Product Safety Regulation (EU) 2023/988, especially manufacturer risk analysis, traceability, contact channels, clear instructions and safety information, corrective action and recall obligations.
- U.S. Consumer Product Safety Commission public safety warnings concerning lithium-ion battery overheating, ignition, explosion, charger incompatibility and hazardous-battery disposal.
- EU WEEE Directive 2012/19/EU, including the crossed-out wheeled-bin marking for separate collection of electrical and electronic equipment.
- FCC Part 15 statements must be confirmed against the exact equipment authorization filing and model-specific user-manual exhibit.
- Original ORION PRO English user manual supplied by XTAND.
Required Pre-Release Approvals
- Engineering: confirm battery chemistry, capacity, charging controls, temperatures, IP rating, pressure accuracy, failure modes and emergency shutdown.
- Quality/Regulatory: confirm test reports, labeling, serial/batch traceability, translations, complaints and recall process.
- Legal: review warnings, intended use, warranty and jurisdiction-specific consumer law.
- Privacy/Cybersecurity: review app claims, data categories, permissions, retention and incident process.
- Insurance: provide the final manual and risk analysis to the broker/underwriter if requested.
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