CLINICAL HARDWARE AUDIT

The Audit. Verified Integrity.

We don't just review hardware; we audit it for clinical safety. Every device that enters our registry undergoes a complete teardown to verify material purity, thermal stability, and long-term bio-compatibility. If it fails our matrix, it never touches our shelf.

INTERACTIVE LAB

Hardware Teardown &Clinical Comparison

"Explore the internal engineering of verified devices. We expose the components that marketing departments hide."

Virtual Teardown

Select a device to begin the clinical inspection.

Device
STEP 01 // INTERNAL CORE
Medical-Grade Air Pump

The internal diaphragm pump is built to medical standards, ensuring a constant, filtered air stream for balloon inflation.

MATERIAL ANALYSIS

High-Performance Elastomers

AUDIT RELEVANCE

ISO 13485 compliance ensures the air source is free from mechanical lubricants.

ISO 13485

An international standard that outlines the requirements for a quality management system specific to the medical devices industry.

Clinical Comparison

AUDIT ROSTER

Verified Device Classification

We categorize hardware into three tiers of clinical reliability.

I
Tier 1: Clinical Gold Standard

Devices with ISO 13485 certification and 100% isolated airpaths.

II
Tier 2: High-Fidelity Consumer

Exceptional material safety and thermal stability for daily therapy.

III
Tier 3: Specialized Extraction

Manual or niche devices with verified bio-compatible paths.

THE METHODOLOGY

Four Pillars of Hardware Integrity

Our auditing process is binary. A device either meets the standard, or it is excluded from our registry.

Total Thermal Isolation (TTI) is the requirement that inhaled air never comes into contact with electronics, adhesives, or non-certified polymers.

The Standard: Airpath must be ≥ 98% composed of Borosilicate, Ceramic, 316L Stainless, Grade 2+ Titanium, or PEEK.

Failure Criteria: Any presence of internal glue, exposed circuit boards, or non-medical grade plastics in the heat zone.

WHY IT MATTERS

When hardware heats up, cheap materials undergo "off-gassing"—releasing volatile organic compounds (VOCs) directly into the aerosol. By mandating TTI, we ensure that the only thing you are inhaling is the intended plant profile, free from manufacturing byproducts.

VERIFIED BY TEARDOWN

Precision Thermoregulation Control (PTC) ensures that the device maintains a consistent temperature during active inhalation.

The Standard: Real-time temperature fluctuations must remain ≤ ± 2°F during active draw.

Failure Criteria: Thermal crash during draw or overheating that breaches the 455°F combustion threshold.

WHY IT MATTERS

Medical efficacy relies on consistent decarboxylation. If a heater cannot maintain its set point during a draw, the aerosol profile changes, leading to uneven dosing and potential respiratory irritation from combustion byproducts.

VERIFIED BY THERMOCOUPLE

Surgical Grade Compliance (SGC) mandates that all contact surfaces meet international standards for long-term safety.

The Standard: Materials in contact with plant matter or mucosa must be ISO 10993 or USP Class VI compliant.

Failure Criteria: Use of industrial-grade metals, non-certified silicone, or reactive coatings.

WHY IT MATTERS

Chronic exposure to non-biocompatible materials can lead to systemic toxicity. We ensure that every surface touching your plant or your body is as safe as a surgical instrument.

VERIFIED BY MATERIAL CERT

For a device to be truly medical-grade, it must be capable of being fully sanitized without degradation.

The Standard: Device must be ≥ 90% submersible in 91% ISO or withstand 250°F steam sterilization.

Failure Criteria: Non-removable vapor paths, porous materials that trap bacteria, or warping under heat.

WHY IT MATTERS

Bio-film accumulation is a major risk in long-term therapy. If a device cannot be returned to a "factory clean" state easily, it poses a long-term respiratory health risk.

VERIFIED BY CLEANING TEST
THE CLINICAL BRIDGE

From Consumer Tech to Medical Device.

We are bridging the gap between "boutique hardware" and "durable medical equipment." Our goal is to provide the data necessary for healthcare providers to prescribe these units with confidence.

HCPCS Reclassification

Mapping hardware to existing medical coding for future insurance reimbursement.

Titrated Delivery Data

Verifying that hardware can deliver precise, repeatable aerosol dosages for clinical study.

Lexicon Reclassification

CONSUMER TERM

"Vaporizer"

CLINICAL TERM

Precision Thermal Extraction Unit

CONSUMER TERM

"Hitting it"

CLINICAL TERM

Titrated Aerosol Inhalation