Important Purchasing Information
Unable to sell to: American Samoa, Canada, Guam, Northern Mariana Islands, Puerto Rico, U.S. Virgin Islands, United States
Unable to deliver to: Botswana, Colombia, Egypt, Ecuador, Ghana, Pakistan, Philippines, Saudi Arabia, South Africa, Uganda, Kenya, Chile, India, United Kingdom
14 days.
MOQ Shipping Dimensions (Depth), cm = 30
MOQ Shipping Dimensions (Length), cm = 40
MOQ Shipping Dimensions (Width), cm = 50
MOQ Shipping Weight (G.W) (kgs) = 6.8
Key Features
Design
The Ellavi uterine balloon tamponade comes with a supply bag has a 1000ml fluid capacity. The balloon is thin walled which ensures low expansion pressure.
Tubing
The Ellavi UBT comes with 2.25m tubing installed, this allows for vertical hydrostatic pressure control and rapid filling of the balloon.
T-valve Tap
The T-valve tap allows for the system to be either fixed or free-flow.
Effective Balloon
The UBT is equipped with a large enough, medical grade elastomer balloon (>750ml) to fill the entire uterus and apply equal pressure to the uterus wall once filled.
Specifications
- Intrauterine Balloon Tamponade for Treatment of PPH
- Free Flow
- Pressure Control
- Latex and DEHP Free
- EO Sterile
- 1000ml Supply Bag
- Flexible tube >1700mm with tap
Standard Accessories
- 1x Supply Bag
- 1x Uterine Balloon with tubing and T-valve pre-assembled
- 1x IFU
Optional Accessories & Add-ons
None
Product Documents, Manuals & Brochures
Brochure
Specifications
Confirmation letter of MDD
Regulatory Certificates
CE Certificate
Confirmation letter of MDD
ISO 13485 & 11135
MCC License
Technical report EU 2018
Videos
FAQ
How high should the supply bag be?
On onset of treatment, hang the supply bag between 1m and 1.5m for rapid filling. During monitoring, adjust the hight of the supply bag according to the systolic blood pressure of the patient (SBPx1.3=height in cm).
What are the reasons for an expelled balloon?
1. The balloon was placed incorrectly. 2. Two fingers absent from the cervix while the balloon is filling. 3. Height of the supply bag is not adjusted (contraction of the uterus expelled the balloon)
Does the vagina require packing with the Ellavi UBT?
No, packing is not required.
Can the patient be transported/transferrred with the Ellavi UBT in situ?
Yes
Studies & Trials
Package Contents
- 1x 1000ml Supply Bag or Reservoir
- 1x pre-assembled flexible tube with bag connecter, T-valve, internal tube and balloon
- 1x Instructions for Use (IFU)
- 1x Sterilization Pouch with coated Tyvek, PE film
- 1x Polymer bag with tyvek strip
Warranty
Testimonials
Not available at this time
