USER MANUAL (Instruction for Use) SW 2.9
Device / System Description
Version 2.9.7 dated 2020-12-23 Page 40 of 75
_
WARNING
Do not use the sterile tubing more than once!
Due to the long and thin lumen and the connected reservoir, safe and effective re-
use of the vacuum tube, if at all, can only be achieved through great effort.
Additionally, liquid residue, which cannot be ruled out during cleaning of the tube
system, can lead to impairment of the vacuum (vacuum loss) during operation.
Due to the long lumens, safety of sterilization operations can only be guaranteed
for clean, bacteria-free and brand new tubes. Sterilization of tubes with high
bacteria contamination or residues would by all means require significant effort.
Furthermore, the manufacturer has validated a one-time EO sterilization. Other
processes or multiple repetitions are not validated and it is unknown what possible
material affects could occur through re-use.
(Information required by Medical Device Directive 93/42 Annex I, Section 13.6 (h))
Do not use tubing when the sterile packing is damaged or already open!
Do not use the tubing as a suction device to remove water from the patient’s eye.
The fluid absorber is an important safety device which will not work properly when
filled with fluids.
Do not use disposable tubing from other suppliers. Only disposable tubing supplied
by SCHWIND can be used with the device.
The use of other disposable tubings can result in malfunctions.
Use of disposable tubings which are not original SCHWIND disposable tubings may
result in major or severe surgical consequences, may damage the Carriazo-
Pendular.
SCHWIND cannot be held liable for damages resulting from the use of disposable
tubings more than once and/ or the use of tubings from other manufacturing
sources.
Follow the instructions written on the tubing package.
4.4.2 Lid Speculum
Made of surgical stainless steel.
Especially designed for the requirements of
the Carriazo-Pendular
CAUTION
Use only silicone hoses which are provided by SCHWIND eye-tech-solutions
or order them at SCHWIND.
Use of silicone hoses which are not original from SCHWIND eye-tech-
solutions may impair negative the reprocessing procedure.
To Next Page
Loading...