Product Name
FreeAccess™ Abdominal Retainer System
Introduction
FreeAccess™ is an inflatable intraabdominal organ retainer system. The product is only to be used by medically trained personnel and requires a basic understanding of laparoscopic surgical techniques. The product is a single use medical device.
Patient group
The product is intended for use on adults. It is the responsibility of the Surgeon to determine which patients are suitable for its use.
Performance characteristics (Intended Use)
FreeAccess™ can be used for a variety of laparoscopic surgical procedures. It serves to hold back the internal organs in such a way that they do not interfere with the operation process and the operator has a clear field of vision. This enables the surgical team to reduce the angle of the patient’s head-down positioning (Trendelenburg) and the possible complications of ventilation or the cardiovascular system. The product is compatible with existing theatre Carbon Dioxide (COâ‚‚ ) pressure systems and can be used in an MRI scanner.
The product is intended to be used for a limited exposure (up to 24 hours).
Product description
The product consists of an Introducer and the FreeAccess™ Inflatable Bag/Balloon Device and this Instructions for Use.
Materials
Thermoplastic Polyester Polyurethane (TPU); Polycarbonate (PC); Fluoropolymer (Polyester); Polyurethane (PUR).
Contra-indications
Do not use on patients with known sensitivities to the listed materials. Do not use on pregnant women. Do not use on children.
Warnings
Do not leave in patient after Surgery. Do not modify this device in any way. Do not use if FreeAccess™ does not stay inflated. Withdraw from patient and replace with new device.
Instructions for use
1. Before carrying out any procedure, please ensure that you include FreeAccess™ in your Check List of Equipment, to enable it to be signed off at the end of the operation.
2. Prior to use, please make sure that both the device and the packaging are intact and not damaged, such as perforated balloons and crushed pouches. Do not use FreeAccess™ in either case.
3. Open the packaging, avoiding bacterial and viral contact, making sure that all the quoted components are there and ready for use. Ideally FreeAccess™ should be used immediately after the packaging has been opened, to avoid possible contamination.
4. Place the patient in a Trendelenburg position to allow the organs to be initially excluded from the surgical field. See figure 1
5. Check that the FreeAccess™ balloon is correctly contained within the Introducer, then insert the Introducer into the patient’s abdominal incision, which has already been prepared for your surgical procedure. See figure 2
6. Push the FreeAccess™ out of the Introducer using a sterile surgical blunt instrument or gloved finger into the body cavity (abdominal or pelvic) where you intend carrying out your surgical procedure. Withdraw the Introducer from the incision after the FreeAccess™ has been placed into the body cavity. Ensure the finger of the balloon is left outside of the abdomen.
7. Use your sterile atraumatic forceps (not supplied in pack) to help position the FreeAccess™ within the abdominal or pelvic cavity and in the area you require the organs to be isolated, using the tabs (ears) coloured red and blue at either side of the device. See figure 3
8. To assist you with the positioning, FreeAccess™ has been fitted with two tabs (ears) either side of the device, whereupon you can grab the device with your forceps. Typically, the red tab is for the right-hand side and the blue tab for the left-hand side. Additionally, there is a peripheral flat external flap along one edge, to help you with the required positioning of FreeAccess™, which can be grabbed.
9. Once the bag/balloon is in position, connect the Insufflator for COâ‚‚ gas to the inflation luer. If required, you may also wish to add some medical saline (0.9%) to aid stability of the device in the abdominal cavity. The amount of medical saline is at the discretion of the user depending on the situation. Simply disconnect the COâ‚‚ from the inflation luer and utilize a sterile syringe with a luer lock facility, (not supplied) to add the saline. Saline should be used at temperatures between 36 and 37 degrees Celsius to avoid shock.
10. Set the gas pressure typically at a maximum of 15 mmHg and inflate slowly. See figure 4.
11. Inflate as required, but please make certain that you do not over-inflate. However, if inadvertently an excess of gas is used, FreeAccess™ is supplied with a Pressure Release Valve, to prevent any over-inflation.
12. Once you are satisfied that the inflated balloon is in the required position and the balloon is holding its inflation and does not deflate spontaneously, you can also reduce the Trendelenburg position and COâ‚‚ gas pressure (8-10mmHg), and then you can proceed with the surgical procedure, unrestricted by other organs moving into your surgical field.
13. Once your surgical procedure is completed, deflate the FreeAccess™ device and then very gently withdraw FreeAccess™. See figure 5. Once removed, check to confirm that the device is complete, this is to make sure no parts are left inside the patient.
Other Directions
These products are intended for single use only. Re-use can lead to spreading of microorganisms and contamination. Reprocessing can negatively affect the function and mode of operation of the product and lead to a hazard for the patient. Dispose of the products in accordance with your internal instructions and local regulations. All serious incidents occurring in connection with the product shall be reported to the manufacturer and the responsible authority.
