Jada Dosage/Direction for Use

Instructions for Use: Pre-Jada Patient Evaluation: Precaution: The safety and effectiveness of the use of Jada in patients with placenta accreta have not been evaluated.
1. Evaluate for lacerations, retained products of conception, or other causes of bleeding, and remove any organized clots prior to using Jada.
Note: Prioritization of laceration repair and placement of Jada for atony-related bleeding is up to the judgment of the provider. Repair of vaginal and external genital lacerations can be performed with the Jada in place.
Precaution: Use care when suturing any lacerations to avoid puncturing or damaging the material of the Cervical Seal.
Jada Preparation: 2. Inspect the packaging and Jada before use.
3. Ensure that the bladder is empty (straight cath or place Foley) in order to facilitate palpation and contraction of the uterus.
4. Connect a vacuum canister and sterile standard vacuum tubing to a regulated vacuum source.
5. Attach a sterile luer tapered syringe to remove any air that is in the Cervical Seal.
6. Fill sterile luer tapered syringe with 60 mL of sterile fluid.
Jada Placement: Post Vaginal Delivery or Post Cesarean Section After Closure of Hysterotomy: 7. Secure visualization of the cervix to confirm it is dilated ≥3 cm to allow for placement of Jada.
8. Using a hand, compress the Intrauterine Loop near the distal tip for support and insert Jada transvaginally, leading with the Intrauterine Loop. Avoid excessive force. Use gentle traction on the anterior cervical lip to stabilize the cervical opening, if needed. An instrument can be placed on the anterior cervical lip, but do not grasp Jada with an instrument to facilitate intrauterine insertion.
9. Place Jada such that the Intrauterine Loop is located in the uterus and is oriented in the frontal plane of the body by assuring the Seal Valve is oriented at either 3 or 9 o'clock. Ultrasound may be used to confirm proper placement of the Intrauterine Loop within the uterus.
10. After insertion, the Intrauterine Loop should be within the uterus while the Cervical Seal should be located within the vagina at the external cervical os.
Note: If clinically relevant, a B-Lynch compression suture may be used in conjunction with Jada.
Filling of Cervical Seal and Connection of Vacuum: 11. While securely holding the Seal Valve and avoiding unintentional proximal or distal movement of the Cervical Seal away from the external cervical os, attach a sterile luer tapered syringe to fill the Cervical Seal with 60 mL of sterile fluid. If needed, add up to another 60 mL of sterile fluid to achieve coverage of the external cervical os and create a seal for vacuum.
12. Set the vacuum source to 80 mmHg +/- 10 mmHg while occluding the end of the tubing (80 mmHg = 1.5 psi = 10.7 kPa = 3.2 in Hg = 106.7 mbar).
Precaution: 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.
13. After the vacuum pressure has been set and confirmed, connect Jada to the sterile vacuum tubing. Blood flow into the vacuum tubing and/or improvement in uterine tone should be noted after initiation of vacuum.
Note: Confirm that the Cervical Seal is positioned at the external cervical os after the system is in place (Cervical Seal is filled and the vacuum is connected). Reposition Jada if required to facilitate a seal.
14. After initial evacuation of any pooled blood, presentation may vary during treatment: there may be no further blood evacuation, or additional blood moving into the tubing, or accumulation of blood in the canister. If blood flow does not stop or slow sufficiently, consider increasing the vacuum pressure in accordance with the user's clinical judgment, not to exceed a maximum pressure of 90 mmHg.
15. Tape Jada to the patient's inner thigh without tension.
Precaution: Ensure Jada is secured with tape to avoid unintentional dislodgement.
16. Leave Jada in place with the vacuum applied until: PPH/abnormal postpartum uterine bleeding is controlled for at least 1 hour, the uterus is firm, patient is stable.
17. Consider prophylactic antibiotics for prolonged use.
Verify and End Treatment: 18. Before disconnecting vacuum, assess the patient to confirm that treatment is no longer needed.
19. Disconnect vacuum tubing from Jada while vacuum is on to collect any blood from the tubing into the canister. Secure tubing in case re-application of vacuum is needed.
20. Attach a luer tapered syringe to remove the fluid from the Cervical Seal and keep the Jada System in place for at least 30 minutes while monitoring for any recurrent uterine bleeding.
Jada Removal: Precaution: to avoid uterine inversion, do not remove the Jada while vacuum is applied. Always disconnect Jada from vacuum tubing before removal.
Precaution: remove all fluid from the Cervical Seal prior to removing Jada to avoid disruption of the vaginal mucosa or any sutured lacerations.
21. If PPH/abnormal postpartum uterine bleeding remains controlled and the uterus remains firm for a minimum of 30 minutes after vacuum is disconnected, remove Jada.
22. Place one hand on the abdomen to secure the uterine fundus while the other hand slowly withdraws the device.