SM_708378 AC
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Instructions for Use
387.362 SynFrame Light-transmitting Rod
Please read these instructions for use, the Synthes brochure “Important Informa-
tion” and the corresponding surgical techniques carefully before use. Ensure that
you are familiar with the appropriate surgical technique.
A thorough understanding of the principles and methods used in laser endoscopy
and electro-surgical procedures is necessary to avoid shock or burn risks to patients
and users as well as damages to other equipment and instruments.
Material(s)
Material: Standard:
Stainless Steel (SSt)
ASTM F 899, ASTM A 276, ISO 7153-1
The SynFrame Light-transmitting Rod (387.362) is used to illuminate deep cavities
in the human body.
The light cable connection corresponds to the ACM Standard. Adapters for Wolf
and Storz are included.
❶
Light exit
❷
Light cable connection
ACM Standard
❸
Adapter for Wolf
❹
Adapter for Storz
❺
Fixation area for SynFrame Clamp (387.347) and Holder for Optics (387.365)
The SynFrame Clamp for Holding Rings (387.347) and Holder for Optics (387.365),
which is used to connect the Light-transmitting Rod to the SynFrame Holding Ring
(387.336) and the SynFrame Half-Ring (387.337), can be attached to the SynFrame
Light-transmitting Rod on the entire length of the shaft of the Light-transmitting
Rod (see figure 1,
❺
).
For further instructions concerning the handling of the SynFrame Light-transmit-
ting Rod refer to the surgical technique for SynFrame, (DSEM/SPN/0616/0530).
General safety instructions
Prior to each use, check the SynFrame Light-transmitting Rod and its accessories
for any possible optical and mechanical defects, both of the surface and of the
distal and proximal fiber optical end faces, to avoid the risk of injury.
To prevent the Light-transmitting Rod from being damaged, avoid bending stress.
This can lead to damages to the optical components and result in malfunctioning
of the equipment. The SynFrame Light-transmitting Rod is not sterile on delivery
and has to be cleaned and sterilised prior to each use. Do not use damaged or
defective Light-transmitting Rods. In case of doubt, please contact your Synthes
representative.
Combination with other medical devices
There are numerous therapeutic vistas open for combi nations with laser and HF
surgery, pneumatic or electro-hydraulic lithotriptors. In such cases, please follow
the manufacturers’ operating manuals and safety instructions of devices and
accessories used.
While using the SynFrame Light-transmitting Rod with electro-medical devices,
ensure that the BF conditions (insulated, earth-free part) are maintained.
The simultaneous use of NMR (Nuclear Magnetic Resonance) and the SynFrame
Light-transmitting Rod can be dangerous and lead to artefacts. Please follow the
corresponding manufacturers’ guidelines and safety instructions.
The use of the SynFrame Light-transmitting Rod in combination with electro-medi-
cal devices and/or power- driven accessories for light transmitters can lead to an
addition of leakage currents. Failure of one of the light sources can lead to risks for
the patient or hinder the surgical procedure. Keep an additional operational light
source at hand or use light sources with a substitute lamp.
In combination with high performance light sources, the temperature of the light
source and the instruments can reach levels which can cause burns. Light of high
radiance energy can lead to an increased temperature in the tissue. Hence, avoid
direct contact with tissue and make sure the distance of the distal end of the
SynFrame Light-transmitting Rod and the tissue is at least 10 mm.
Treatment before device is used
Synthes products supplied in a non-sterile condition must be cleaned and
steam-sterilized prior to surgical use. Prior to cleaning, remove all original pack-
aging. Prior to steam-sterilization, place the product in an approved wrap or
container.
Disinfection and cleaning
Use mild cleaning and disinfectant solutions to remove impurities.
If a cleaning agent is used together with the disinfectant, it is advisable to use both
disinfectant and cleaning additive from the same manufacturer. Make sure the
solutions are mutually compatible and strictly follow the manufacturer’s instruc-
tions with regard to concentration and soaking time.
Note:
Do not decontaminate and clean the SynFrame Light-transmitting Rod in
an ultrasonic bath.
Cleaning
Cleaning can be done manually or mechanically.
Manual cleaning
– Use only mild cleaning substances for dissolving the impurities. These cleaning
agents have to be approved of by the manufacturer for cleaning endoscopes.
– For manual cleaning, use a soft cloth, cotton and special brushes.
–
Remove dirt on the optical surfaces (see figure 1,
➊
and
➋
) using cotton soaked
in alcohol (70% Ethanol) or a neutral cleanser.
– After cleaning, rinse thoroughly with de-ionised (distilled) water and dry with
cotton or a soft cloth to remove the last traces of impurities and residues of the
cleaning agents.
– Finally dry the SynFrame Light-transmitting Rod and the individual accessories
carefully using a tissue or soft absorbent cloth.
Special instructions for manual cleaning
–
The fiberoptical surfaces must not be treated using sharp objects. Generally, the
SynFrame Light-transmitting Rod must be cleaned with maximum care to avoid
damage because of excessive pressure, impact, bending or letting it fall.
Mechanical cleaning
– Clean and disinfect the SynFrame Light-transmitting Rod in suitable rinsing
machines fitted with special endoscope cleaning programs. It is also possible to
use a thermodisinfector. For mechanical procedures, ensure that the SynFrame
Light-transmitting Rod remains firmly on the instrument holder and is not dam
-
aged by other instruments.
Procedure
– Place the SynFrame Light-transmitting Rod and the disassembled accessories in
a suitable instrument carrier as prescribed by the manufacturer of the rinsing
machine. Ensure that there are no rinsing shadows.
– Select the appropriate endoscope cleaning program depending on the machine
load and the instructions of the manufacturer. The cleaning solutions have to be
recommended for light-transmitters by the manufacturers.
– In case of mechanical cleaning, clean all residues of the rinsing program tho-
roughly, as there could be decoloring and formation of patches, especially with
regard to a subsequent sterilisation. For the last rinsing round, use de-ionised
water. This can be supported by the use of a suitable neutralisation agent, which
can improve the post-rinse results.
Figure 1
❶
❷
❸
❹
❺
