Gamma Finder^™ III Wireless Gamma Detector

DEVICE DESCRIPTION

The GAMMA Finder® III is a device used for the pre- and intra-surgical detection of substances labeled radioactively (gamma emitter). It is exceptionally user-friendly due to its unique concept as a battery-powered, autonomous, hand-held device. The GAMMA FINDER® III displays the detected gamma radiation by means of an acoustic signal and, synchronously, with a numerical value in cps (counts per second) on the display, which is proportional to the activity level. 

ESSENTIAL PERFORMANCE

The device measures gamma radioactivity in a certain energy range. Main application is the measurement of Tc-99m and the dual isotope mode which measures I-125 and Tc-99m simultaneously.

INTENDED USE

The GAMMA FINDER® III is intended for the detection of gamma radiation in the energy range from 20 keV to 512 keV. The GAMMA FINDER® III is indicated for the extra- and intra-operative detection of radioactively labelled substances mainly in the fields of breast cancer and malignant melanoma. 

CONTRAINDICATIONS

Dosimetric applications, detection of radiation other than gamma, and detection of radiopharmaceuticals with radiation energies outside the above listed energy range are contraindicated. 

WARNINGS

Read the manual carefully and become familiar with the operation and function of the GAMMA FINDER® III and its accessories before using the GAMMA FINDER® III in the operating room. Non-observance of the instructions listed in this manual can lead to

 • injuries of the patient,

• injuries of the surgical and nursing team or service personnel or

• damages or failure of the GAMMA FINDER® III and accessories.

The manufacturer reserves the right to modify the appearance, graphics, and technical data of the product through continued development of its products.

The words WARNING, CAUTION and NOTE carry special meanings.

•  WARNING! The safety and/or health of the patient, user, or a third party are at risk. Comply with this warning to avoid injury to the patient, user, or third party.
•   CAUTION! These paragraphs include information provided to the operator concerning the intended and proper use of the GAMMA FINDER® III or accessories.

NOTE! These paragraphs contain information to clarify the instructions or provide additional useful information. 

Safety Information

The applicable regulations regarding the handling of radioactive substances must be observed. Federal Law (only for U.S. market)

CAUTION! U.S. law stipulates that the GAMMA FINDER® III is to be used only by a physician or under supervision of a physician.

CAUTION! Radioactive substances regulation: The applicable regulations regarding the handling of radioactive substances must be observed.

CAUTION! Improper operation due to interferences: Avoid using the GAMMA FINDER® III adjacent to other devices or stacked with other devices. This may lead to improper operation of the GAMMA FINDER® III. If you cannot avoid such use, observe the GAMMA FINDER® III and the other devices to verify that they are operating normally.

WARNING! Condensation / Water penetration: Protect device GAMMA FINDER® III from moisture. Do not use if moisture has penetrated the device.

WARNING! Replacement device and accessories in case the device or any of the accessories fail during surgery, a replacement device and replacement accessories should be kept within close proximity to be able to finish the operation with the replacement components.

WARNING! Low or empty battery: Always use a fully charged device GAMMA FINDER® III. Using the device GAMMA FINDER® III with low or empty battery could cause stress to the operating team or harm the patient.

WARNING! Contamination: Do not use device and/or accessories if signs of contamination are detected. Make sure the device or/and accessories can no longer be operated until a qualified service technician conducts the appropriate tests and repairs.

WARNING! Cleaning and disinfection baths: Cleaning and disinfection baths are expressly prohibited. They can cause serious damage to the GAMMA FINDER® III.

WARNING! Obvious defects: Never use the device if it has suspected or confirmed defects, especially if these involve the power plugs or the mains power supply connection cables. In this case have the device repaired by authorized service personnel.

WARNING! Defect suspected or detected: Do not use this system if a defect is suspected or detected during the function check. This also applies to obvious defects, especially defects and damage to the power plug and power cord. Contact customer service.

WARNING! Not explosion-proof: The GAMMA FINDER® III is not explosion-proof. Do not operate the GAMMA FINDER® III in the vicinity of explosive anesthetic gases or in the vicinity of oxygen-enriched environments.

WARNING! Original accessories: For your own safety and that of your patient, use only original accessories (see Accessory List in IFU).

WARNING! Insulating bag: Do not use the insulating bag as a sterile sleeve. The insulating bag was designed for shipping the GAMMA FINDER® III and is, in consequence, not sterile.

WARNING! Use of sterile sleeve: Do not use the device without sterile sleeve.

WARNING! Sterile sleeve: The sterile sleeve may not be reused nor sterilized twice.

WARNING! Packaging: Check the sterile sleeve before removing from the packaging to ensure that the packaging is intact and that the expiration date is still valid.

NOTE! Storage: The sterile sleeves must be stored at room temperature. The shelf life for sterile sleeves is 3 years.

NOTE! Hygiene regulations: Observe applicable hygiene regulations when disposing of the sleeve.

NOTE! Regular charging: Regular charging of the GAMMA FINDER® III to ensure that it is always ready for use.

NOTE! Professional qualification: The operation of the device GAMMA FINDER® III is reserved for persons with the relevant professional qualifications and trained to use the device.

Exclusion of liability

The manufacturer is not liable for direct or consequential damages, and the warranty becomes null and void if:

• the GAMMA FINDER® III and/or the accessories are improperly used, prepared, or maintained; • the instructions and rules in the instructions for use are not adhered to;

• unauthorized persons perform repairs, adjustments, or alterations on the GAMMA FINDER® III or accessories

• unauthorized persons open the GAMMA FINDER® III;

• the prescribed inspection and maintenance schedules are not adhered to. The handing over of technical documents does not constitute authorization to make repairs or alterations to the GAMMA FINDER® III or accessories.

CAUTION! Modifying the GAMMA FINDER® III and/or its accessories is not permitted. Authorized Service Technician: Only authorized service technicians may perform repairs, adjustments, or alterations to or on the GAMMA FINDER® III or accessories sand use the service menu. Any violation will void the manufacturer's warranty. Authorized service technicians are trained and certified only by the manufacturer.

CAUTION! Sterilization: The GAMMA FINDER® III itself may not be sterilized. The sterilization of the GAMMA FINDER® III can have a negative impact on its function and safety. W.O.M. WORLD OF MEDICINE GmbH rejects any and all responsibility for any damage or undesired events resulting from failure to observe this warning and when sterilizing the GAMMA FINDER® III.

Care and Maintenance

The service and maintenance of the GAMMA FINDER® III and its accessories must be carried out as instructed to ensure the safe operation of the device. Therefore, test function and completeness before each use to ensure the safety of the patient and user/surgical team. Maintenance of the GAMMA FINDER® III may not be performed during its use and operation.

Contamination

Before shipping, decontaminate GAMMA FINDER® III and accessories in order to protect the service personnel. Follow the instructions listed in these instructions for use. If this is not possible,

• the product must be clearly marked with a contamination warning and

• must be double-sealed in safety foil.

The manufacturer has the right to reject contaminated products for repair.

NOTE! Professional qualification: The operation of the device GAMMA FINDER® III is reserved for persons with the relevant professional qualifications and trained to use the device.

The GAMMA FINDER® III may only be used in hospitals or operating rooms. 

Please consult product labels and inserts for indications, contraindications, hazards, warnings, precautions and directions for use.

BD-75603