Is the Spacemaker™ Plus dissector system latex-free?
The Blunt Tip Trocar contains natural rubber latex that may cause allergic reactions. The latex in the Spacemaker™ Plus blunt tip trocar is the base material of the cannula balloon, which is encapsulated in a silicone material; in normal use there is no patient contact.
How many combinations of product are there in the system?
The Spacemaker™ Plus dissector system consists of four combinations (sold separately) of two access ports and two dissectors integrated into a single, easy-to-use instrument. The four combinations are: SMBTTRND BTT Access Port and Round Dissector; SMBTTOVL BTT Access Port and Oval Dissector; SMSBTRND SBT Access Port and Round Dissector; SMSBTOVL SBT Access Port and Oval Dissector.
Is this product single patient use?
This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury. Reprocessing and/or re-sterilization of this device may create the risk of contamination and patient infection. Do not reuse, reprocess or re-sterilize this device.
What do the letters BTT and SBT stand for?
BTT is blunt tip trocar; SBT is structural balloon trocar.
What are the seal specifications?
The rubber seal in the access port will accommodate instruments between 10 and 12 mm in diameter. The reducer tab on the side of the hub will accommodate a 5 mm scope. The access device’s body assembly contains an internal valve which prevents gas leakage when there is no instrument in place or when a 10-12 mm diameter instrument is inserted into the trocar sleeve.
Has the old flip tab seal system changed?
Yes, the previous 5 mm and 10 mm flip tab seal system has been replaced with a single 10/12 mm scope seal that comes attached to the port and 5 mm reducer tab that will accommodate a 5 mm scope.
What are the access port specifications?
The port is 3.5 inches long with a 13 mm inner diameter.
What are the dissector specifications?
The dissector cannula is 10 inches long with a 10 mm inner diameter.
What are the dissection balloon specifications?
The round dissection balloon is 4.5 inches in diameter when inflated with 1000cc. The oval dissection balloon is 7.5 inches wide, 4.5 inches tall and 4.5 inches deep when inflated with 1000 ccs of air. The inflation bulb delivers approximately 20 ccs per pump.
Can the balloons be inflated with either the syringe or bulb?
Yes, the syringe is titratable up to 20cc and the bulb delivers approximately 30cc per pump.
Are the dissection balloons rigid?
The oval dissection balloon is rigid; the round dissection balloon is elastic.
Can the dissection balloons rupture?
Yes, never inflate the dissection balloons with more than 40 hand pumps of air.
Should the dissection balloons be furled in their package?
The round dissector balloon is packaged unfurled. The oval dissector balloon is packaged furled within a self-contained jacket that is designed to peel away as the oval balloon inflates in situ.
Is there an integral insufflation port?
Yes, there is a clearly marked CO2 port on the body of the access Cannula for insufflation.
Where does one attach the bulb or syringe to inflate the balloons?
The bodies of the access port and dissector are clearly labeled with bulb and syringe icons. The bulb and syringe can be used interchangeably to inflate as needed.
Which end of the bulb inflates?
The bulb is clearly marked with an “inflate” end and a “vacuum” end to deflate.
How does the assembly snap together?
The latching mechanism between the access port and dissector balloon and dissector balloon and dissector obturator will only engage when the instrument is oriented properly. To unlock, depress the side tabs and gently pull.
How does the foam locking collar work?
A compression spring holds the foam locking collar in place on the shaft of the access port. To adjust, squeeze the opposing tabs gently and slide to the desired position. Release the tabs to lock in position.
Does the system come with pre-packaged lubricant?
Yes, all systems include a 6 gram Endo-Lube™ seal / instrument lubrication kit.