Surgical direct offers the Surgical
Instruments range of Zoellner Suction made of premium
quality stainless steel.
Material: Stainless Steel
Rusting Prevention Procedure: Passivated
Ultrasonic Cleaned: Yes
Usage: Left Hand or Right Hand
Tests Performed: Boil Test, Performance Test, Shape Test
Packing: Individually Packed
QC Passed: Yes
Surname:Zollner (sometimes spelled Zöllner, Zoellner)
Instrument Type: Ear
Working Surface Style
Latex or Latex-Free:
General Instruction for Reprocessing of Reusable Surgical Instruments
following instructions are for all reusable surgical instruments
supplied by Surgical direct Instruments Limited, unless stated otherwise with the
packaging of the product. These instructions are intended for use only
by person with the required specialist knowledge and training.
reprocessing medical devices, always handle with care, wearing
protective clothing, gloves and eyewear in accordance with local Health
& Safety procedures.
- Follow instructions and warnings
as issued by the manufacturers of any decontaminants, disinfectants and
cleaning agents. Wherever possible avoid use of mineral acids and harsh,
- No part of the process shall exceed 140ºC.
- Some sensitive materials (e.g.
Aluminium) are damaged by high alkaline solutions (pH>10). Devices
with long, narrow cannula, hinges and blind holes require particular
attention during cleaning.
LIMITATIONS ON REPROCESSING
- Repeated processing has minimal effect on these instruments.
- End of life is normally determined by wear and damage in use.
- Any specific limitations on the number of reprocessing cycles shall be made available with the instrument.
INSTRUCTIONS FROM POINT OF USE
possible, do not allow blood, debris or bodily fluids to dry on
instruments. For best results and to prolong the life of the medical
device reprocess immediately after use. If they cannot be reprocessed
immediately, use an enzymatic foam spray cleaner to help prevent soil
PREPARATION FOR DECONTAMINATION
- Reprocess all instruments as soon
as it is reasonably practical following use. Disassemble only where
intended, without the use of tools unless specifically provided by the
manufacturer. Where instructions for disassembly are required, these are
available with the device.
cleaning may not be suitable for all lumens and cannula in which case
clean manually with a water jet gun, if available, and an appropriate
brush (and stilette if provided) that reaches the depth of the feature.
After manually cleaning, pass all devices through an automatic cleaning
cycle to achieve disinfection.
- Use only either CE marked or
validated washer-disinfector machines and low foaming, non-ionising
cleaning agents and detergents following the manufacturers instructions
for use, warnings, concentrations and recommended cycles.
- Load instruments carefully, with any box joints and hinges open and so that any fenestrations in instruments can drain.
- Place heavy instruments with care in the bottom of containers, taking care not to overload wash baskets.
- Place instruments with concave
surfaces facing down to prevent pooling of water. Where available, use
appropriate attachments to flush inside reamers and devices with lumens
- Ensure that soft, high purity water which is controlled for bacterial endotoxins is used in the final rinse stage.
instruments have been validated using a washer-disinfector cycle
validated to include two cold rinses at <35ºC, a detergent cycle and a
rinse cycle both at >50ºC, a disinfection cycle operating at a
temperature of between 80ºC and 90ºC for a minimum holding time of 1
minute (actual holding time in excess of 2 minutes 50 seconds) and a 20
minute drying cycle. The detergent used was low foaming, non-ionising
spray wash detergent cleaner (max 12pH) and the rinse aid a neutral pH
low foaming, non-ionic surfactant with isopropyl alcohol.
Manual cleaning is not advised if an automatic washer-disinfector is
available. If the equipment is not available, use the following
cleaning is NOT a disinfection process: When manual cleaning is used it
may not be possible to disinfect the device prior to further handling.
- Use a double sink system
(wash/rinse) dedicated for instrument cleaning (not used for hand
washing). Ensure that the water temperature does not exceed 35ºC.
- In the first sink, keeping the
instrument submerged, with an autoclavable brush, apply CE marked
cleaning solution to all surfaces until all soil has been removed. Pay
particular attention to serrations, teeth, ratchets and hinges, always
brushing away from the body and avoiding splashing. Ensure rongeurs and
hinged instruments are thoroughly cleaned in both open and closed
- In the second sink, rinse
instruments thoroughly with soft, high purity water which is controlled
for bacterial endotoxins, so that the water reaches all parts of the
instrument, then carefully hand dry or use a drying cabinet.
- After cleaning, visually inspect
all surfaces, cannulations, ratchets, joints, holes and lumens for
complete removal of soil and fluids. If ANY soil or fluid is still
visible, return the instrument for repeat decontamination.
- Apply surgical grade lubricant to hinges, joints and moving parts as per the lubricant manufacturer’s instructions.
INSPECTION AND FUNCTIONAL TESTING
an instrument is returned to the manufacturer / supplier, the
instrument must be decontaminated and sterilized and be accompanied with
the relevant documented evidence.
- Visually inspect and check: - all
instruments for damage and wear; cutting edges are free from nicks and
present a continuous edge; jaws and teeth align correctly; all
articulated instruments have a smooth movement without excess play;
locking mechanisms (such as ratchets) fasten securely and close easily;
long, slender instruments are not distorted; any component parts fit and
assemble correctly with mating components.
- Remove for repair or replacement any blunt, worn out, flaking, fractured or damaged instruments.
- All instruments to be packed following local protocol in accordance with ISO 11607-1 or AAMI/CSR technique.
STERILIZATION (OUTSIDE USA)
- Autoclaves should comply with the requirements of, and be validated and maintained in accordance with ANSI/AAMI ST79.
- Pre-Vacuum Moist heat
sterilization operating at temperature 132°C bar for a minimum holding
time of 4 minutes – always following the instructions of the machine
- When sterilizing multiple
instruments in one autoclave cycle, ensure that the sterilizer
manufacturers stated maximum load is not exceeded. Ensure instruments
are dry before sterilization.
- Autoclaves should comply with the
requirements of, and be validated and maintained in accordance with EN
285, EN 13060, ENISO 17665.
- Either CE marked or validated
vacuum autoclave operating at 134-137ºC bar for a minimum holding time
of 3 minutes – always following the instructions of the machine
- When sterilizing multiple instruments in one autoclave cycle, ensure that the steriliser manufacturers stated maximum load is not exceeded.
- Ensure instruments are dry before storage, and stored in dry, clean conditions at an ambient room temperature.
is the responsibility of the reprocessor to ensure that the
reprocessing as actually performed using equipment, materials and
personnel in the reprocessing facility achieve the desired result. This
requires validation and routine monitoring of the process. Likewise any
deviation by the reprocessor from the instructions provided must be
properly evaluated for effectiveness and potential adverse consequences.
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