Medtronic PTEYE-1 Instructions for Use

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PARATHYROID DETECTION SYSTEM PROBE

MODEL PTEYE-1

INSTRUCTION FOR USE INSERT

DESCRIPTION
The Parathyroid Detection (PTeye) System aids surgeons in confirming suspected parathyroid tissue that has been

located visually by the surgeon during common surgical procedures using a probe assembly.
The probe assembly includes one glass fiber optic element that emits non-ionizing radiation at 785nm in the near IR
range (NIR) and one fiber optic detector elements that collect and transmit the fluorescence emitted by the tissue to a
photo detector. Tissue detection is based on the ratio of the fluorescent response of the parathyroid to the thyroid
tissue; the fluorescence of thyroid tissue is much lower than the parathyroid.

INDICATIONS FOR USE

The AiBiomed Parathyroid Detection System (Model PTeye) is an adjunctive tool intended to aid in the
identification of parathyroid tissue by confirming parathyroid tissue already visually located by the surgeon.

CONTRAINDICATIONS

There are no known contraindications for use for the AiBiomed Parathyroid Detection System (Model PTeye).

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.

Warnings

1. 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.

2. 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.

3. This device shall only be used with original and manufacturer’s accessories and replacement parts. Use of

other parts or materials may degrade safety.

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4. NO modifications of this equipment is allowed.

5. Do not reuse the probe assembly. Discard probe assembly after each surgery.

6. Do not use the device if the environmental conditions do not meet the environmental requirements of the

device

Precautions

1. 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.

2. Prior to each use, visually inspect the PTeye system, 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.

3. Do not excessively bend or kink the flexible portion of the probe assembly.

4. 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).

5. Handle all equipment carefully. If the fiber optic probe assembly is dropped, it can be damaged, which

renders the system unusable.

6. This device should only be used in compliance with its intended use.

7. 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.

STERILIZATION

The PTeye-1 Probe is provided sterile. Do not re-sterilize Compromised performance and cleaning hazards are
imminent.

STORAGE AND HANDLING

Store at room temperature. Avoid storing the PTeye-1 Probe at conditions of excessive heat or humidity. Do not use
after expiration date on label. All components should be handled carefully to avoid damaging the device. Inspect all
parts for damage prior to use, do not use any damaged parts. Do not reuse device.

PROCEDURE

Verifying Probe Assembly Function

The probe assembly contains delicate fiber optic cables. To verify that these have not been damaged during the
shipment process, follow these steps.

1. Inspect the probe sterile package for any signs of damage. If any damage is found, discontinue using the

probe and return the probe to AiBiomed.

2. Inspect the probe for any signs of damage, particularly paying attention to the probe tip. If any damage is

found, discontinue using the probe and return the probe to AiBiomed.

Note: AiBiomed recommends that you purchase additional probe assemblies so that a backup is available in case
one is dropped or becomes unsterile during an operation.

Follow the IFU instruction for the PTeye Device (D121254_EN) in order to use the PTeye-1 Probe, make sure you
have read the entire IFU and pay special attention to the warnings section.