Jada Special Precautions

Warnings: Avoid excessive force when inserting the Jada into the uterus or trauma to uterine wall may occur, including perforation.
The safety and effectiveness of the Jada System in delivery at a gestational age <34 weeks or, if multiples, uterus judged <34 weeks size, have not been established. With smaller uterine size, there is potential for increased risk of perforation and expulsion.
Signs of patient deterioration or failure to improve indicate the need for reassessment and possibly more aggressive treatment and management of postpartum hemorrhage (PPH)/abnormal postpartum uterine bleeding.
Jada is not a substitute for surgical management and fluid resuscitation of life-threatening PPH/abnormal postpartum uterine bleeding.
Remove air from Cervical Seal prior to device use to minimize risk of air embolism if Cervical Seal bursts.
Always fill the Cervical Seal with sterile fluid. Never inflate with air, carbon dioxide, or any other gas to minimize risk of air embolism if Cervical Seal bursts.
Precautions: The safety and effectiveness of the use of Jada in patients with placenta accreta have not been evaluated.
Use care when suturing any lacerations to avoid puncturing or damaging the material of the Cervical Seal.
The maximum vacuum pressure is 90 mmHg. Do not increase the vacuum pressure higher than 90 mmHg. (90 mmHg = 1.7 psi = 12.0 kPa = 3.5 in Hg = 120.0 mbar) or tissue trauma may occur.
After initiation 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.
Jada should not be left within the uterus for longer than 24 hours due to the possibility of an adverse tissue reaction or infection.
The safety and effectiveness of the use of Jada in patients with Disseminated Intravascular Coagulation (DIC) have not been evaluated.