User Manual
Riester Surgical is
Manufacturer and Exporter of all kinds of Dental,
Surgical, Tc Tip Instruments, Ent Devices, Laryngoscope, Holloware, Beauty,
Veterinary Instruments
INSTRUCTION MANUAL – PLEASE READ BEFORE USE
SURGICAL INSTRUMENTS
The Lapa Master Industry culture is one of responsibility and accountability,
which means we take ownership of our projects with a clear view of the final
objective. We are providing the responsiveness to customer needs of a small
business, but with the added innovation, advanced manufacturing methods and
qualified distribution network of a truly global company. This, in essence,
created what Riester Surgical stands for today: world-class products and
services for our customers.
INNOVATION
At Lapa Master Industry we foster innovation by combining decades of experience
in developing and manufacturing diagnostic devices with out-of-the-box,
innovative thinking. Our people are always eager to explore new
technologies. As a result, we are now in
the great position of being able to launch innovative products every year, while
still having a well-filled product pipeline for the future.
CUSTOMER SATISFACTION
Lapa Master Industry 's customers expect nothing less than world-class products
and services. Consequently, they are the center of all our efforts and
activities, right across the company, from research and development through to
manufacturing, marketing and sales. Designed for demanding, everyday use in
doctors´ practices and hospitals, many of our products are developed through
close cooperation between our engineers and specialists from research centers
and university hospitals.
During the development phase, our test procedures and facilities lay the
foundation for products of outstanding quality, even before the actual
manufacturing process starts.
EMPOWERMENT
Our employees are key to our success and we continue to invest in their
development. From their initial training when they join Riester Surgical,
followed by ongoing development programs and corporate management training, our
employees are encouraged to contribute through excellence and teamwork. Our
objective is to empower people and help them assume responsibility to help us,
as a team, achieve our ambitious company goals.
PRODUCT LAUNCHES
Lapa Master Industry Product Launches Surgical Instruments for ENT, Ophthalmology
& Dermatology Pocket Instruments - Premium ENT Diagnostic and Ophthalmic Instruments,
Laryngoscopes, Fiber Optic (F.O.) Laryngoscopes, Laryngoscopes with Direct
Illumination, Disposable Laryngoscopes, Laryngoscope Sets, Gynecology Sets,
INTENDED USE These instructions for use are valid for Surgical instruments made
of stainless steel, such as Extracting
Forceps, instruments for Bone Surgery, Scalpels, Knifes, Scissors, Forceps,
Clamps, Retractors, Probes, Scalars Spatulas, Suture Root Elevators instruments
with special instructions.
Lapa Master Industry sets higher standards than required by norms and guidelines.
In order to comply with these exceptionally high internal standards, we only
use high-grade materials from reliable suppliers and apply the latest
manufacturing methods, with every product having to pass several intermediate
and final quality checks. All our manufacturing personnel receive expert
training to ensure world-class finishing and quality. Our products come with a
minimum two-year warranty.
TESTS
Surgical instruments are high-quality products whose proper handling and use
will be described in the following. In order to minimize hazards for patients
and users these directions must be closely obeyed. Application, maintenance and
test of the instruments may only be carried out by especially skilled staff.
HANDLING
The instruments must not be over stressed by twisting or levering as this may
lead to damages or cracking of the instruments.
PURPOSE / FIELD OF APPLICATION
These operating instructions are valid for standard surgical instruments of the
production of Riester Surgical The user decides according to his specialized
knowledge whether the instrument may suitable for the intended purpose.
DISPOSAL
Instruments that cannot be repaired or reprocessed should be disposed in
accordance with the respective disposal guidelines of the hospital.
PRODUCT MATERIALS
We are using Materials as per international standards. We have expertise to
remove calculus efficiently from the Materials while retaining its sharpness
which is durable for a longer period of time. Riester Surgical Instruments
hold the highest quality standards throughout the creation of the instrument
from raw materials to finished product.
We believe in our products and provide our clients 100% satisfaction guarantee. Riester Surgical Instruments that are stainless steel require periodic
sharpening. Please feel free to contact us for any information.
QUALITY
100% Satisfaction Guaranteed All our Instruments are produced with high quality
stainless steel and are thoroughly checked and inspected during all phases of
production, In order to ensure that they correspond to the international
standards laid down by the ISO 13485, ISO 9001, ISO7153-1 EN10088-1 and CE
standards and are confirmation of their compliance to use.
REPROCESSING DIRECTIONS
Surgical instruments may in general only be processed by specially skilled
staff possessing the specific knowledge for this kind of work. Detailed
information to the maintenance of instruments are available in the “Red
Brochure” of the www.lapamasterind.com links to laws, norms and specialized
maintenance committees can be found.
ADVICE
Instruments made of stainless steel must not be put in physiological saline
solutions (NaCl), as longer contact may lead to corrosion dam- ages.
Instruments may only be sterilized after a previous cleaning and disinfection.
INSTRUCTION
Due to the design of surgical instruments and the used materials, it is not
possible to determine a limited number of reprocessing cycles. The lifetime of
surgical instruments is therefore determined by the function / wear of the
device. In case of damage the device must be reprocessed before sending back to
the manufacturer for repair.
REPROCESSING
INSTRUCTIONS
Preparation at the point of use:
Remove gross soiling by submerging the instrument into cold water (<40°C)
immediately after use.
Don't use a fixating detergent or hot water (>40°C) as this can cause the
fixation of residuals which may influence the result of the reprocess- in
process.
TRANSPORTATION
Safe storage and transportation in a closed container to the reprocessing area
to avoid any damage and contamination to the environment.
PREPARATION FOR DECONTAMINATION
The devices must be reprocessed in an opened or disassembled state. Instruments
must be placed on adequate supports or trays. The nature of the supports or
trays must not have any negative influence on the result of the following
cleaning and disinfection by rinsing or ultrasonic treatment.
MANUAL PRE-CLEANING
Immerse the instrument into cold tap water for at least 5 minutes. Dismantle
the instruments If possible and brush under cold tap water until all visible
residues are removed. Inner lumen, threads and holes are flushed each with a
water jet pistol for minimum 10 seconds in the pulsed mode. Immerse the
instrument into an ultrasonic bath with an alkaline or enzymatic detergent
(0,5%) and treat with ultrasound for 15 minutes at 40°C.
Remove the instruments from the bath and rinse again with cold tab water.
The cleaning bath must be changed at least once a day, or if required. Any
pollution may influence the result of cleaning / disinfection and may favor
corrosion.
MANUAL CLEANING
In case of manual cleaning, the cleaning process needs to be adapted to the
pre-treatment. The used detergents must be compatible, in order to avoid any
negative influence on the cleaning/disinfection result.
The detergent must be suitable for the treatment of surgical instruments.
The manufacturer's instructions regarding concentration and reaction time must
be strictly obeyed. Use only soft brushes, no metal brushes. Channels and
hollow parts must be rinsed thoroughly. If necessary, a high-pressure hose must
be used.
Rinse the instruments with
running clear water.
Dry the instruments thoroughly.
The cleaning bath must be changed at least once a day, or if required.
CHEMICAL DISINFECTION
The chemical disinfection follows the manual cleaning. A detergent, suitable
for surgical instruments made of stainless steel must be used.
PACKAGING STORAGE
Storage of sterilized instruments in appropriate packaging in a dry, clean and
dust free environment at modest temperatures of 5°C to 40°C, and at a constant
humidity. The distance between shelf and floor should be at least 30cm. Storage
duration time is to be determined by the user.
REPROCESSING VALIDATION STUDY INFORMATION
The following testing test devices, materials & machines have been used in
this validation study; Detergent.
ADDITIONAL INSTRUCTIONS
If the described chemistry and machines are not available, it is the duty of
the user to validate his process.
It is the duty of the user to ensure that the reprocessing processes including
resources, materials and personnel are capable to reach the required results.
State of the art and often national law requiring these processes and included
resources to be validated and maintained properly.
WARRANTY
The products are made of high grade medical stainless steel and are controlled
prior to sale. In case of any error or inconvenience, please feel free to
contact our service.
Lapa Master Industry cannot provide any guarantee weather the instruments are
suitable for the respective intervention. This has to be determined by the
user.
Lapa Master Industry does not provide any liability for any damages arising from
pure chance. Lapa Master Industry does not provide any liability for any damages
deriving from contravening against this manual. In case of using the
instruments on patients with Lapa Master Industry does not provide any liability
for the reprocessing of the instruments.