DD-961

endoflip-system-with-display-front-prod

The Endoflip™ 300 impedance planimetry system is used to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters.

Contact a representative

Indications, Safety, and WarningsIndications for useThe Endoflip™ 300 platform and Endoflip™ catheters:

The Endoflip™ 300 system is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus in patients from five years of age.

It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The Endoflip™ 300 platform and Esoflip™ catheters:

The Esoflip™ ES-310 balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastroesophageal reflux and radiation therapy.

The Esoflip™ ES-320 balloon catheter is indicated for use to dilate esophageal strictures due to esophageal surgery, primary gastroesophageal reflux and radiation therapy.

The Esoflip™ ES-330 balloon dilation catheter is indicated for use in a clinical setting for dilating the gastroesophageal junction of a patient with achalasia.

Contraindications

The Endoflip™ 300 system is contraindicated where endoscopy is contraindicated.

The Endoflip™ 300 system is contraindicated for use in patients with actively bleeding varices in the esophagus, or when using Esoflip™ catheters, with active esophageal perforation.

Catheters have additional contraindications. Refer to the instructions for use for each catheter type for additional information.Warnings

Federal law (United States) restricts the Endoflip™ platform to sale by, or on the order of, a physician.

To reduce the risk of electric shock, always disconnect the device from AC power before opening any enclosure.

To avoid risk of electric shock, this equipment must only be connected to a mains supply with protective earth.

Do not use the device if the Endoflip™ 300 display system is not functioning correctly or is not clearly readable.

Do not use this device if an error condition cannot be corrected.

The Endoflip™ 300 pump system should be mounted on the Endoflip™ 300 cart provided.

When in use, keep the catheter and power cord stowed or positioned in a safe manner in order to avoid a tripping or snagging hazard.

Do not allow the fan cover at the rear of the Endoflip™ 300 pump system to become covered or obstructed.

Use the Endoflip™ 300 platform only with the Medtronic supplied power cord. Do not use the device if any damage to the AC power cord (such as frayed wires, cracks, or cut insulation) is evident. The power cord is not field-serviceable.

Medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and must be installed and put into service according to the EMC information provided in this instruction for use (see Appendix B).

Before using the Endoflip™ 300 platform on a patient, allow the device to acclimate to conditions of use following transport or storage.

Connect the Endoflip™ 300 platform to power and turn the device on before installing the syringe to the system.

Use the Endoflip™ 300 platform on a patient when in normal operating mode only. Do not attach to the patient during power on self-test (POST) or in service mode. Maintain continuous observation of the patient during use.

In the unlikely event that the Endoflip™ 300 platform ceases normal operation during a procedure, use the back panel on/off switch to turn the Endoflip™ 300 pump system unit off, remove the syringe from the unit and retract the syringe plunger manually to withdraw any remaining fluid from the balloon catheter. The catheter can then be carefully removed from the patient.

Use the Endoflip™ 300 platform only with parts and accessories approved by Medtronic.

Do not place fingers or hands near the syringe drive system when it is moving.

Service of this device should be performed only by a qualified service technician.

To ensure proper operation, do not make unauthorized modifications to the Endoflip™ 300 platform.

Transport, set up, and store the Endoflip™ 300 platform so that it does not pose a tripping hazard.

Use proper technique for lifting the Endoflip™ 300 platform or sub-components.

To minimize the risk of puncturing or damaging the Endoflip™ 300 platform, do not use sharp objects on the Endoflip™ 300 display system.

This equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. To minimize the risk of fire, use the Endoflip™ 300 platform in well-ventilated areas away from flammable anesthetics.

To minimize the risks associated with excess inflation pressure, observe the patient and all alarms during use, and observe diameters and pressure during a procedure, and while making settings or setting changes. Verify that there are no leaks in the catheter during the purge cycle.

During operation, check that the amount of fluid in the syringe matches the amount shown onscreen, and verify that the syringe refills as indicated when the plunger aligns with the arrow on the syringe (indicating that the balloon is empty) before carefully removing the catheter from the patient.

Replace the catheter if a Dest value remains consistently at a maximum or minimum compared to adjacent Dest values; this can indicate a faulty catheter.

Do not use this device near magnetic resonance imaging (MRI). For accurate measurements, high-frequency devices such as electrosurgery or diathermy /cautery equipment should be deactivated.

Remove the catheter if the patient requires defibrillation.

Display devices and their adapters connected to the HDMI connector of the Endoflip™ 300 platform must meet the requirements of IEC 60601-1 and be located in the same room where the Endoflip™ 300 platform is being used.

The Endoflip™ 300 platform must be connected to a wall outlet or a single-outlet extension only. Do not use multiple-outlet sockets other than outlets approved by Medtronic.

Do not connect additional components to the isolation transformer.

Install all equipment according to applicable national wiring requirements.

If used in conjunction with endoscopy equipment, the leakage current from the Endoflip™ 300 platform catheter may be additive to the leakage current from the endoscope.

To ensure proper operation and to minimize the risk of patient injury, only use the pre-filled syringe supplied with the catheter. Different catheter part numbers are supplied with different solution concentrations.

To avoid the risk of personal injury, do not attempt to lean on or use the Endoflip™ 300 platform for support.

Catheters have additional warnings. Refer to the instructions for use for each catheter type for catheter-specific warnings.

DD-961

endoflip-system-with-display-front-prod

Not what you're looking for?

United States

Customer Care Team

DD-961 endoflip-system-with-display-front-prod

Not what you're looking for?

United States

Customer Care Team

DD-961

endoflip-system-with-display-front-prod