Certification: ISO13485&CE MDR

Key Features

(1)High-Capacity & Flexible I/O: Features a 16/32-channel amplifier, supplemented by 1 extra low-current stimulation port and a 9-channel stimulation box to handle complex monitoring scenarios.
(2)Comprehensive Modality Library: Supports over 16 flexible measurement modalities—including EMG, MEP, SEP, BAEP, VEP, and TOF—to meet the diverse needs of spinal, neurosurgical, and ENT procedures.
(3)Integrated & Robust Consumables: Utilizes a proprietary suite of integrated consumables, engineered for superior anti-interference capability to ensure waveform clarity and accuracy in the demanding OR environment.
(4)Streamlined Operational Workflow: The all-in-one consumables system and intuitive interface are designed to reduce setup time and simplify intraoperative procedures, enhancing overall efficiency.

Advantage

• Unmatched Procedural Versatility in a Single Platform,With support for over 16 modalities—including EMG, MEP, SEP, BAEP, VEP, and TOF.
• Uncompromised Signal Integrity for Confident Interpretation, The system is complemented by a suite of proprietary, integrated consumables, specifically engineered with robust anti-interference capability. This design ensures the acquisition of high-fidelity, low-noise waveforms.
• Streamlined Workflow for Enhanced Operational Efficiency,The Cynapse IONM system addresses this through a highly streamlined workflow. The use of integrated consumables and an intuitive interface significantly reduces preparation time and simplifies intraoperative management.

ONE (1) YEAR LIMITED DEPOT WARRANTY

1. Warranty Provider and Term

The warranty is provided and conducted strictly by the manufacturer of this particular product, not by Medaza Europe d.o.o.. The manufacturer of this particular product warrants to the original purchasing entity ("Buyer") that the hardware products sold shall be free from defects in materials and workmanship under normal clinical use for a period of one (1) year from the date of shipment.

2. Depot-Only Return Procedure

Warranty service is strictly a depot-return process conducted directly by the manufacturer of this particular product.

• First Step (Intake): To initiate a warranty claim, the Buyer must not contact the manufacturer directly. The Buyer must contact Medaza Europe d.o.o. first by email at contacteurope2@medaza-platform.com.

• Delegation: Upon receipt of the email, Medaza Europe d.o.o. will delegate and coordinate the direct connection between the manufacturer of this particular product and the Buyer, facilitating the return logistics and securing the required Return Merchandise Authorization (RMA) number.

• Shipment: No shipments will be accepted by the manufacturer's facility without an active, authorized RMA number. The product must be securely packaged in its original packaging (or equivalent protective packaging) and shipped directly to the designated service facility of the manufacturer of this particular product.

3. Allocation of Shipping Costs (Two-Way Shipping)

The Buyer assumes full financial responsibility for all shipping logistics, packaging, handling fees, customs/tariffs, and insurance transit costs associated with the warranty claim. This includes:

• Inbound Shipping: The cost to safely transport the product from the Buyer's facility to the designated service location of the manufacturer of this particular product.

• Outbound Shipping: The cost to return the repaired or replaced product from the facility of the manufacturer of this particular product back to the Buyer's designated location.

4. Universal Recall & Systemic Defect Exception

The shipping cost allocation in Section 3 shall be waived solely in the event that the returned product is officially determined by the manufacturer of this particular product, Medaza Europe d.o.o., or an authorized regulatory body (e.g., CE/MDR) to be subject to a Universal Recall, Safety Alert, or a verified batch-wide Systemic Manufacturing Defect. In such extraordinary circumstances, the manufacturer of this particular product will cover standard two-way ground shipping costs.

5. Warranty Exclusions

This warranty does not cover:

• Disposable clinical consumables (including but not limited to needles, sutures, and catheters) once packaging is opened.

• Damage caused by accident, abuse, liquid spills, improper sterilization, neglect, or unauthorized modifications/repairs.

• Normal wear and tear or cosmetic degradation.