INDICATIONS, SAFETY, AND WARNINGS
The PTeye™ parathyroid detection system is an adjunctive tool intended to aid in the identification of parathyroid tissue by confirming parathyroid tissue already visually located by the surgeon.1
There are no known contraindications for use for the PTeye™ parathyroid detection system.
Device Warnings and Precautions
This equipment is designed for use by medical professionals familiar with its required techniques and these instructions for use. Read and follow all warning and cautionary notices and instructions included in this IFU. The words WARNING, PRECAUTION, and NOTE carry special meanings and they should be read carefully. WARNING: The safety and/or health of the patient, user, or a third party is at risk. Comply with this warning to avoid injury to the patient, user, or third party. PRECAUTION: This contains information concerning the intended use of the device or accessory. Damage to the equipment is possible if these instructions are not followed.
NOTE: A note is added to provide additional, focused, information.
- Due to limitations in parathyroid detection of autofluorescence by the PTeye System in certain disease states, the device is not recommended for use in patients with secondary hyperparathyroidism and in patients with parathyroid cysts.
- The PTeye System is intended to be an aid in the identification of parathyroid tissue and not as a parathyroid locator. The use of this device has not been evaluated as a parathyroid tissue locator.
- The device is only completely isolated from the mains if the External Power Supply’s power plug is disconnected from the AC Mains.
- Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure.
- Do not attempt to open or service the console, as this may void your warranty. The console does not contain any user-serviceable parts inside. Removing the cover may produce an electric shock hazard by exposing you to dangerous high voltage or other risks. Should the system malfunction, return it for service immediately.
- Always connect the probe assembly and the foot pedal before turning on the power switch. Turn the power off before disconnecting the probe assembly or foot pedal. Never disconnect the probe assembly or foot pedal while the system is in use. If the unit is on and the probe assembly is not connected, the laser will emit potentially harmful light from the front of the console, which could harm eyes and skin.
- Do not use the AiBiomed Model PTeye system if LED power indicator does not light up when the power switch is in the ON position and the foot pedal is pressed. (See Figure 3 in Section 2.2 for LED power indicator and power switch location).
- When the unit is on, never point the tip of the probe assembly at someone else’s face or look at it directly. Looking at the laser could potentially be harmful to the eyes. If you are unsure if the laser is on, look at the laser-on LED on the front of the console, not at the probe assembly itself.
- Never point the laser at eyes, skin or point away from the surgical site. The laser radiation can damage eyes and other sensitive skin. In an unusual case, the system may detect parathyroid tissue when pointed at a light source with a specific wavelength and frequency.
- Do not use the AiBiomed Model PTeye system in the presence of flammable materials. This includes anesthetics, gases, disinfecting agents, cleaning products, or any similar materials susceptible to igniting due to electrical sparking.
- Equipment grounding is vital for safe operation. Plug the power cord into a properly grounded main supply outlet with voltage and frequency characteristics compatible with those listed on the unit/power supply or in the Technical Specifications section 9.2. Do not use plug adapters or extension cords as these devices nullify the safety ground and could cause injury.
- This device shall only be used with original and manufacturer’s accessories and replacement parts. Use of other parts or materials may degrade safety.
- This equipment should not share an electrical outlet or grounding with life support or life sustaining equipment.
- For the protection of service personnel, and for safety during transportation, all devices and accessories that are returned for repair must be prepared for shipment as described in “Returning the Device” section of this manual. The manufacturer has the right to refuse to carry out repairs if the product is contaminated.
- NOT for use in an Oxygen Rich Environment.
- NO modifications of this equipment is allowed.
- Connecting any equipment that has not been supplied as part of this System to Multiple Socket Outlets may result in increased leakage currents. Use an IEC Approved Isolation Transformer to isolate any such interconnections from the ME System.
- Keep the device in its upright position at all times. Feet downwards. This will allow for simple installation and disconnection of the probe assembly (Applied Part).
- Do not reuse the probe assembly. The PTeye-1 Probe is provided clean and sterile in its original sterile package. The probe is no longer clean or sterile past its use in each patient. Do not re-sterilize as no method can guarantee cleanliness or sterility past the first use. Discard probe assembly after each surgery.
- The PTeye device will acquire a baseline data point by the probe making contact with the thyroid tissue whenever the foot pedal is pressed for more than one second. If unintended data points are acquired because the probe has made contact from tissues other than the thyroid (unless the thyroid has been previously removed or ablated for which muscle or trachea tissue may be used instead of the thyroid tissue) be sure to reset the unit by pressing the power switch on the console off and on again to clear any collected data and start a new measurement.
- The PTeye sound level can be decreased to Zero by pressing the Volume Down button repeatedly. At that stage, the system does not emit any sound and the user can only receive feedback via the display. The system resets to sound ON whenever the power to the system is cycled.
- Due to a small sample size, limited clinical data is available regarding the safety and effectiveness of the PTeye System for rare disease states such as tertiary hyperparathyroidism, concomitant thyroid-parathyroid diseases, malignant parathyroid diseases, or other circumstances when prophylactic thyroidectomies are performed in individuals at high-risk for certain diseases such as MEN2A.
- Do not use the device with incompatible equipment or peripherals that are not authorized by AiBiomed. Doing so may void existing certifications and/or warranties.
- Before plugging in the device, visually inspect the PTeye system prior to each use, including console, probe assembly, external power supply, power cord, and foot pedal to ensure there are no visible cuts, cracks, or other damage. If any damage is found, do not use the system; contact your AiBiomed customer service representative for assistance.
- Do not expose the console to moisture, operate it in wet areas, or place liquids on or above the console.
- Place the console on a rigid surface to ensure good audio reception (the speaker is on the bottom of the unit).
- Do not excessively bend or kink the probe assembly. Handle the flexible portion of the probe assembly with care.
- Do not excessively bend or kink the instrument power cord or the cord for the foot pedal.
- Store the device and all peripherals in a protective container to prevent the possibility of damage when not in use. Do not store the device in a location where it will be exposed to temperatures exceeding 140°F (+ 60°C).
- After each use, thoroughly clean the console.
- Handle all equipment carefully. If the fiber optic probe assembly is dropped, it can be damaged, which renders the system unusable.
- This device should only be used in compliance with its intended use.
- To carry out safe operation it is absolutely necessary to carry out proper care and maintenance of the device and accessories. See “Maintenance” section of this manual.
NOTE: Receipt of technical documentation from the manufacturer does not authorize individuals to perform repairs, adjustments, or alterations to the device or accessories. Only authorized service personnel may perform repairs, adjustments or alterations on the device and accessories. Any violation will void the manufacturer’s warranty. Authorized service technicians are trained and certified only by the manufacturer. The Manufacturer will make available on request circuit diagrams, component part lists, descriptions, calibration instructions and other information required for service to any AiBiomed Authorized Service Center.