Jada Special Precautions

The safety and effectiveness of the use of Jada in patients with known or suspected Placenta Accreta Spectrum (PAS) disorders (e.g. placenta accreta, percreta or increta) have not been evaluated.
Use care when suturing any lacerations to avoid puncturing or damaging the material of the Cervical Seal or when placing a surgical compression suture to avoid inadvertently suturing the intrauterine loop of the Jada in place.
The maximum vacuum pressure is 90 mmHg. Do not increase the vacuum pressure higher than 90 mmHg or tissue trauma may occur. (90 mmHg = 1.7 psi = 12.0 kPa = 3.5 in Hg = 120.0 mbar).
After connection of vacuum, blood flow into Jada or the vacuum tubing and/or improvement in uterine tone should be noted. If this does not occur, the Cervical Seal and/or the vacuum may not be effective. If so, refer to Troubleshooting under Cautions for Usage.
During treatment, the presence of intermittent or continuous air flow through Jada and vacuum tubing may indicate an issue with the Cervical Seal location or Cervical Seal coverage. If so, refer to the Troubleshooting under Cautions for Usage.
If the clinical situation warrants use of Jada for longer than 24 hours, the risk increases the possibility of an adverse tissue reaction or infection.
If prolonged use is necessary due to persistent or continued bleeding, consider prophylactic antibiotics.
To avoid uterine inversion, do not remove Jada while vacuum is applied. Always disconnect Jada from vacuum tubing before removal.
Remove all fluid from the Cervical Seal prior to removing Jada to avoid tissue disruption.
Uterine damage or disruption of hysterotomy sutures could occur if the Cervical Seal is inflated past the cervical os.