Indications, Safety, and Warnings

The Endoflip™ 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 5 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™ system is contraindicated where endoscopy is contraindicated.
• The Endoflip™ system is contraindicated for use in patients with actively bleeding varices in the esophagus.

Potential complications

Potential complications include:

• Allergic reaction
• Anaphylaxis
• Bleeding
• Cardio-respiratory complications
• Dental trauma
• Infection
• Pain
• Perforation
• Pulmonary aspiration
• Vasovagal response

Warnings

• Federal law (U.S.) restricts this catheter 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 the enclosure.
• Do not use the device if any damage to the AC power cord (such as frayed wires, cracks, or cut insulation) is evident.
• Do not use the device if the touchscreen is not functioning correctly or is not clearly readable.
• Do not use this device if an error condition cannot be corrected.
• The Endoflip™ system should be mounted on a flat stable surface. 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 air inlet at the side of the unit or ventilation ports at the rear to become covered or obstructed.
• Use the Endoflip™ system only with the supplied power adapter (part number EF-500). Do not use the device if any damage to the power adapter (such as frayed wires, cracks, or cut insulation) is evident. The power adapter 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 instructions for use (see Appendix B: Specifications).
• Before using the Endoflip™ system on a patient, allow the device to acclimate to conditions of use following transport or storage.
• Do not insert the syringe into the Endoflip™ system before connecting power or powering on.
• Use the Endoflip™ system on a patient when in Normal or barostat 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™ system stops normal operation during a procedure, use the back panel on/off switch to turn the 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™ system only with parts and accessories approved by Covidien.
• Do not place fingers or hands near the syringe drive system when it is moving.
• Service on this device should be performed only by a qualified service technician.
• To ensure proper operation, do not make unauthorized modifications to the device.
• Transport, set up, and store the device so that it does not pose a tripping hazard.
• Use proper technique for lifting the device.
• To minimize the risk of puncturing or damaging the device, do not use sharp objects on the touchscreen.
• 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 this device 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 refer to the display to 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 electro-surgery or diathermy /cautery equipment should be deactivated.
• Remove the catheter if the patient requires defibrillation.
• Display devices and their adapters connected to the VGA connector of the Endoflip™ system must meet the requirements of IEC 60601-1 and be located in the same room where the Endoflip™ system is being used.
• The Endoflip™ system must be connected to a wall outlet or a single-outlet extension only. Do not use multiple-outlet sockets other than outlets approved by Covidien.
• Install all equipment according to applicable national wiring requirements.
• If used in conjunction with endoscopy equipment, the leakage current from the Endoflip™ system catheter may be additive to the leakage current from the endoscope.
• When using a catheter with integrated pressure sensor, for optimal pressure measurements, do not expose the balloon portion of the catheter to excessive light during operation.
• Do not make a connection to the rear USB port when Endoflip™ is connected to a patient.
• 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, place the Endoflip™ unit on a flat, stable surface. Do not attempt to lean on or use the Endoflip™ system for support.
• Connect the Endoflip™ system to power and turn the device on before installing the syringe to the system.
• Before use, inspect the catheter assembly from end to end for breakage, occlusions, or debris. Do not use if damage to the parts or packaging is evident, or if any portion of the catheter packaging has been previously opened. Do not use any part after its expiration date or if the expiration date cannot be verified.

Cautions

• Use a unique ID for each patient. Re-entering the previously-entered ID causes previous information to be overwritten when archiving patient data.
• An automatic pressure zero occurs at the beginning of the catheter pre-use check. Following the pressure zero, observe that the pressure reading increases above 10mmHg during the pre-use check. Otherwise the catheter may be faulty and should be replaced.
• To avoid internal part corrosion, do not use chlorine bleach on the touchscreen.

Warnings and Cautions

• Do not use this module if an error condition cannot be corrected.
• Refer to the Endoflip™ system Instructions For Use for warnings and cautions related to the system.

The Endoflip™ 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 5 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™ system is contraindicated where endoscopy is contraindicated.
• Do not use the Endoflip™ system on patients with actively-bleeding varices in the esophagus.
• The EF-322N catheter is not suitable for diameter measurements less than 5 mm.
• The EF-325N catheter is not suitable for diameter measurements less than 5 mm.

Potential complications

Potential complications include:

• Allergic reaction
  
• Anaphylaxis
• Bleeding
• Cardio-respiratory complications
• Dental trauma
• Infection
• Pain
• Perforation
• Pulmonary aspiration
• Vasovagal response

Warnings

• Do not reuse, reprocess, or sterilize. Reuse, reprocessing or sterilization can: compromise the structural integrity of the device; impair performance accuracy due to residual fluid in the balloon and degrade the catheter markings.
• Federal law (U.S.) restricts this catheter to sale by, or on the order of, a physician.
• All catheter components are intended for single patient use only: do not attempt to reuse. Follow all applicable federal and local regulations for disposal or recycling.
• To ensure proper operation and to minimize the risk of patient injury, do not attempt to add or remove fluid from the supplied pre-filled syringes. Only use the pre-filled syringe supplied with the catheter.
  • Note: Different catheter part numbers are supplied with different solution concentrations.
• To avoid damaging the catheter and syringe, store away from sources of heat in specified environmental conditions (see Appendix A: Specifications).
• Before using the Endoflip™ system and catheter on a patient, allow the device to acclimate to conditions of use following transport or storage.
• 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.
• Verify that there are no leaks in the catheter during the pre-use purge cycle described in the Endoflip™ system instructions for use.
• 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.
• Remove the catheter if the patient requires defibrillation.
• For optimal pressure measurements, do not expose the balloon portion of the catheter to excessive light during the procedure.
• Before use, inspect the catheter assembly from end to end for breakage, occlusions, or debris. For single use devices, do not use if damage to the parts or packaging is evident, or if any portion of the package has been previously opened. Do not use any part after its expiration date or if the expiry date cannot be verified.
• Avoid using excessive force during insertion. Withdraw the catheter if resistance is too high.
• In the unlikely event that the Endoflip™ system stops normal operation during a procedure, use the back panel on/off switch to turn the 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.
• Refer to the Endoflip™ system instructions for use for warnings related to the system.

Cautions

• An automatic pressure zero occurs at the beginning of the catheter pre-use check. Following the pressure zero, observe that the pressure reading increases above 10mmHg during the pre-use check. Otherwise the catheter may be faulty and should be replaced.
  
• Refer to the Endoflip™ system Instructions For Use for cautions related to the system.

Notice to the user and/or patient: Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the member state in which the user and/or patient is established.

IFU Part Numbers

• Endoflip™ impedance planimetry system – PT00127746 Rev A 2020-09
• FLIP™ Topography module – PT00127747 Rev A 2020-09
• Endoflip™ EF-322N catheter – PT00124050 Rev A 2020-09
• Endoflip™ EF-325N catheter – PT00124053 Rev A 2020-09