Introduction and General Guidelines
LABORIE¨s Goby? system is a simple and easy-to-use Urodynamics system. With its state-of-the-art technology, testing with Goby becomes streamlined and effortless to perform. Goby provides easier setup time and also gives patients freedom to move with less cables/wires and smaller testing devices.
Getting Started
You should prepare the Goby system before performing any Urodynamics procedures:
? Set up the system hardware. (see page 9).
? Configure test files (if necessary). (see page 27).
? Turn on components and any other accessories.
? Start the Urodynamics procedure(s).
Learning About The Goby System
To learn about the features and how-to of the Goby system, read the following documents or sections of this manual:
? Goby quick start guide (provided with the equipment shipment and on the software disc.)
? Software features and functions (see page 23 to page 57).
? How to perform Urodynamics tests with the Goby (see page 61 to page 69).
Caution and Warnings - READ CAREFULLY BEFORE USE!
Caution
UNITED STATES FEDERAL LAW RESTRICTS THIS DEVICE TO SALE OR USE BY OR ON THE ORDER OF A LICENSED PHYSICIAN.
Warnings
? Only trained technicians should operate this device. The operator must read the Owner¨s manual entirely and refer to any additional training materials before using the device. Optional In-Service is available from Laborie Medical Technologies.
? Before connecting the patient, verify that the Goby system components and software are functioning properly.
? DO NOT USE in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
? DO NOT USE electromyography (EMG) simultaneously with high frequency surgical equipment.
? Where applicable, utilize single-use disposable tubing and catheters designed for Urodynamics measurements. Do not reuse disposable devices. After use, dispose in accordance with local regulations.
NOTE: Pump accuracy is not guaranteed if the pump head tubing is used more than once. DO NOT run pump at a speed exceeding the limitation of the catheter.
? DO NOT USE the Goby system in the same room as an operating magnetic resonance imaging device (MRI.) The strong magnetic field produced during MRI may cause disruption of the devices.
? All transducers should be calibrated prior to use. Calibration should be checked at least every six (6) months or whenever there is a suspicion that the calibration is incorrect. ONLY calibrate the transducers if necessary.
? Use the Goby system with LABORIE equipment and accessories ONLY.
? DO NOT ATTEMPT TO OPEN OR REPAIR the Goby system components by yourself or by an unauthorized party. ONLY Laborie-trained technicians may service the Goby system components.
? LABORIE equipment is licensed by Governments and approved by Safety Agencies to work with LABORIE accessories ONLY.
? LABORIE accessories are licensed by Governments and approved by Safety Agencies to work with LABORIE equipment ONLY.
? LABORIE equipment is warranted to work with LABORIE accessories ONLY.
? LABORIE accessories are warranted to work with LABORIE equipment ONLY.
? DO NOT LEAN anywhere on the system or its devices. The devices are not designed to support the weight of a person.
? Exercise caution when repositioning the Goby system/accessories while patient is connected.
? The built-in pump is designed for use with water and saline only.
? The IV pole is not designed to support the weight of the system. Do not lift the cart or table by holding the IV pole.
? DO NOT ADJUST the IV pole with an infusion bag/bottle on the hook. Always remove the infusion bag/bottle before IV pole adjustments.
? DO NOT STERILIZE the Goby system components.
? Use Input and Output Cables and Cords provided by Laborie Medical Technologies ONLY.
? Exposure to ESD may cause the system to RESET.
? Do not plug in or unplug any transducers when a procedure is running. Always stop the procedure before plugging in or unplugging transducers.
? Do not place your fingers inside the pump head when the pump rollers are moving.
? Ensure all wheels are locked during testing procedures to prevent possible injury to the patient.
? LABORIE is not responsible for loss of patient files or test data. It is strongly recommended to back up patient data on a regular basis.
? Any additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (e.g. IEC 60950 for data processing equipment). Any and all configurations shall comply with the requirements for medical electrical systems. Anyone connecting supplementary equipment to medical electrical equipment configures a medical system and is therefore responsible that the system complies with the requirements for medical electrical systems. Attention is drawn to the fact that local laws take priority over the abovementioned requirements. If in doubt, consult your local Laborie representative or the Technical Service department.
? Transthoracic stimulation, such as maintaining anode and cathode stimulation sites in close proximity, must be avoided.
? Connection of a patient to high frequency surgical equipment and an electromyograph or evoked response equipment may result in burns at the site of the electrical stimulator of biopotential input part electrodes and possible damage to the electrical stimulator or biological amplifiers.
? Operation in close proximity (1 meter) to shortwave or microwave therapy equipment may produce instability in the Stimulator output.
? Avoid accidental contact between connected but unused applied parts and other conductive parts including those connected to protective earth to prevent damage or injury.
? Customers providing their own computer, monitor, or printer for use with the Laborie system may require the use of a Line Isolation Transformer (LIT) to maintain system compliance. In all cases it is advised to check with your local regulations before proceeding. |
