Ibis 200 Anesthesia Vaporizer-Enflurane as anesthetic agent

The ibis200 is a professional anesthesia vaporizer engineered for stability, safety, and precision. It provides high dosage concentrations for rapid wash-in times and effortlessly complies with minimal flow regime demands.

Important Notice for International Markets

• European Union (EU): This device is certified for both human and veterinary medical use across all EU member states.

Certification and Compliance

• MDR Transition and MDD Extension: The ibis200 remains fully eligible for human use in the EU through Dec 31, 2028. Beijing YAFMED has formally applied for Medical Device Regulation (MDR) certification and signed a written agreement with Notified Body TÜV SÜD (0123). Under the transitional provisions of Regulation (EU) 2023/607, the previous MDD CE certification (No. G1 076689 0006 Rev. 01) is legally extended and remains valid for placing the device on the market.
• ISO 13485:2016: Manufactured under a quality management system certified by TÜV SÜD for the design, development, and production of anesthetic vaporizers (Certificate No. Q5 076689 0009 Rev. 01).
• International Standards: Developed in accordance with MDD instructions and conforms to ISO 8835-4, 93/42/EEC, and ISO 5360 standards.
• Manufacturer SRN: CN-MF-000040935.

Key Product Features

• Precise Control: Maintains concentration accuracy across an extended temperature range of 15°C to 35°C even during extreme operating conditions.
• High-Capacity Tank: Features a 300ml anesthetic agent tank (with moist wick) that can hold an entire bottle of agent to minimize waste.
• Safety Filling Systems: Designed with various filler types—including Pour-fil, Easy-fil, Key-fil, and Quik-fil (Sevoflurane only)—to simplify the process and minimize leaks.
• Professional Build: Produced by a leading world supplier with an independent processing center and professional testing devices.

Available Models and Concentration Ranges

The ibis200 is available for four different anesthetic agents:

• Enflurane: 0.2 - 8% Vol
• Isoflurane: 0.2 - 6% Vol
• Halothane: 0.2 - 6% Vol
• Sevoflurane: 0.2 - 8% Vol

Mounting and Compatibility

To integrate with various anesthesia systems, the device supports several mounting types:

• Selectatec Compatible
• Draeger Plug-in
• Cagemount (ISO 23mm tapers)

Technical Specifications

• Flow Meter Range: 0.2 - 15 L/min; 0.2 - 10 L/min for concentrations > 5%.
• Operating Pressure: 70 kPa - 106 kPa.
• Humidity Range: 0% - 95%.
• Agent Filling Volume: Approximately 340ml with a dry wick or 300ml with a moist wick.

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. 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 first by email at contacteurope2@medaza-platform.com.

• Delegation: Upon receipt of the email, Medaza 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, 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.