TransAeris Statement of Intended Use, Warnings, Precautions, Side Effects, and Contraindications

“CAUTION -­­ Investigational device. Limited by Federal (or United States) law to investigational use. TransAeris is CE mark approved and only available outside of United States where CE mark is accepted. The following information provided is intended for investor related inquiries about TransAeris and is not for commercial/promotional purposes in the US.”

TransAeris Statement of Intended Use, Warnings, Precautions, Side Effects, and Contraindications

TransAeris System
Product user manual must be reviewed prior to use of detailed disclosure.

Intended use
TransAeris is a percutaneous intramuscular diaphragm stimulator intended for patients at risk of or on prolonged positive pressure mechanical ventilation. TransAeris is indicated for use in the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD).

Contraindications

  •  None

Warnings

Use only under the direction of a physician. The TransAeris stimulator is electrically powered and may produce tissue damage or electrical hazard if improperly used. The device has accessible controls for clinical staff and NO patient-accessible controls. Do NOT attempt to open the TransAeris stimulator case or attempt any unintended modifications as this will cause a failure in the TransAeris stimulator functionality. Use of TransAeris could interfere with some medical equipment. Some medical equipment could interfere with the use of TransAeris. Implanted cardiac pacemaker or defibrillator, use of the TransAeris stimulator may interfere with these devices. Surgery, use of high-frequency surgical equipment may cause burns where the electrode leads pass through the skin. Such equipment may damage the TransAeris stimulator. Disconnect the TransAeris stimulator when high-frequency surgical equipment is in use. Magnetic Resonance Imaging (MRI) test, the TransLoc electrode is MRI unsafe. Do not perform a MRI test while implanted with the TransLoc electrodes or remove the TransLoc electrodes from the patient before a MRI test. Magnetic Resonance Imaging (MRI) test, the TransAeris stimulator, FrictionLoc connector, and surface electrode are MRI Unsafe. Remove these components from the patient before a MRI test. Use of external electrical stimulation such as transcutaneous electrical nerve stimulation (TENS) should not be done in the chest area near the electrode leads. Unwanted diaphragm contraction could occur. Clinicians should avoid accidental contact between connected but unused applied parts (cable or leads) and other conductive parts including those connected to earth ground or any device with the ground symbol. Safety has not been established for the use of the device during pregnancy. Safety has not been established for the use in patients with epilepsy. Cardiac interference, before conditioning, test interference with cardiac rhythm. Monitor electrocardiogram (ECG) while stimulating at maximal settings. If interference is observed, decrease stimulation settings below level of interaction, turn off identified electrodes, or remove identified electrodes. Do NOT come in contact with TransLoc electrodes during emergency defibrillation. It may lead to electric shock to caregivers.

ELECTROMAGNETIC INTERFERENCE WARNING: Some electrically powered equipment gives off electromagnetic waves which could interfere with TransAeris systems. When using your TransAeris system around electrical equipment, check the TransAeris stimulator screen to make sure the TransAeris system is working. Do follow the electromagnetic compatibility (EMC) information provided. The TransAeris stimulator needs special precautions regarding EMC. To reduce the possibility of interference on the TransAeris stimulator from other electrical equipment or the TransAeris stimulator effecting other electrical equipment, do not use cables or accessories with the TransAeris stimulator other than those specified. RF COMMUNICATION WARNING: Portable and mobile RF communication equipment may affect medical electrical equipment. Ensure proper function of TransAeris when using around such equipment. ELECTRO-STATIC DISCHARGE (ESD): After the TransLoc electrode has been implanted but not connected to the FrictionLoc connector, use caution when handling the electrode leads. Before touching the electrode leads, touch the patient to equalize the electrostatic potential. FLAMMABILITY WARNING: Do NOT use TransAeris system in an oxygen enriched environment, such as a hyperbaric oxygen chamber, or near a flammable anesthetic mixture with air, oxygen, or nitrous oxide. This could cause a fire or explosion.

Precautions

The TransAeris stimulator has been carefully designed and tested to ensure reliability during normal use. However, electronic devices are susceptible to stresses. To avoid damage to the TransAeris stimulator, observe the following precautions: Random failures – The physician should be aware that operational failure of the TransAeris stimulator can occur as the result of battery depletion, mishandling, or random component failure. Possible operational failures of the TransAeris stimulator can include the following:

  • No output or erratic output
  • No sensing or erratic sensing (e.g. during self-testing)
  • False indicator signals
  • Inappropriate variance of rate and output intensity
  • Loss of control of rate, output, intensity, or power

If loss of control of rate, output, intensity, or power occurs, and it is not due to a low battery, disconnect the TransAeris stimulator from the patient, contact Synapse Biomedical Customer Service to return it for evaluation. Service condition – Before each use, evaluate the TransAeris stimulator for damage and observable defects. Do not use the TransAeris stimulator if the case is cracked, the controls are not functioning, the displays are not working, or if the controls, displays, or connectors are broken. The TransAeris stimulus artifact may be seen on monitored bio-potential signals such as continuous ECG monitoring. The TransAeris stimulator is designed for single-patient use. Dispose of the device when finished using on a patient. Do NOT reuse. Reuse may lead to transmission of infection. TransLoc leads, FrictionLoc™ connectors, and cables – Improper connection or fracture of leads or cables may result in failure of the TransAeris stimulator. Inspect exiting electrode leads and cables for damage before use. To avoid patient entanglement with the cable, keep TransAeris close to the patient at all times when in use. If you think the device is not providing enough stimulation, then consult this manual or call Synapse Biomedical Customer Service. This could mean that the TransAeris may not cause the patient’s diaphragm to contract.

Environmental precautions

The TransAeris stimulator has been carefully designed and tested to ensure reliability during normal use. However, electronic devices are susceptible to many environmental stresses. To avoid damage to the TransAeris stimulator, observe the following precautions:

  • Do not expose the stimulator to excessive moisture, heat or severe mechanical shock.  If display indicates system failure or device exposed to excessive moisture, heat or shock, disconnect the TransAeris stimulator and contact Synapse Biomedical Customer Service.
  • To protect the TransAeris against damage due to mechanical shock. Do NOT drop the TransAeris. The TransAeris may break and not be available for use when needed. The TransAeris stimulator should remain in the plastic packaging until needed.
  • To protect the TransAeris against damage due to moisture, Do NOT submerge the TransAeris in liquid. The TransAeris may quit working and not able to use when needed.
  • Avoid contaminating the patient cable connections with blood or other body fluids.
  • Do not attempt to open the TransAeris. The TransAeris is sealed at the factory and opening the TransAeris will damage the device and void the warranty.

Other environmental factors may impact proper performance of the TransAeris in the hospital setting. Use of appropriate environmental health and safety practices will help prevent environmental damage to the TransAeris.

Possible Adverse effects

Possible adverse effects from the use of TransAeris system may include:

  • Cardiac interaction
  • Lead breakage
  • Unretrieved device fragment
  • Electrode dislodgement
  • Skin infection
  • Skin sensitivity due to adhesive
  • Pain or discomfort due to stimulation

For more information, Contact:

Synapse Biomedical Europe S.A.R.L
156 Place des Aubépines
95680 Montlignon, France
Tel: +33 (0)9.60.12.44.98
Fax: +33 (0)1.74.18.08.19
mdiop@synapsebiomedical.com