Only trained and qualified users should handle these instruments after reading this document.

? PRODUCT DESCRIPTION

o Simplicity® Dilator perform specialized functions in specific nasal and sinus procedures.

 

? WARNINGS & PRECAUTIONS

o Visually inspect all instruments before each use for damage or deformations in the metal, such as cracks, sharp edges, debris, rust, residue, whistling during vacuuming or broken components. Do not use any damaged or broken instruments.

o Use aseptic techniques when opening sterile wrapping.

o After use, do not mix contaminated instruments with clean instruments.

 

? SOLID DILATOR USE

o When using the Solid Dilators, hold the dilator in a pen-grip, with the thumb on the flat side, as shown in the figures below. Use the flat side to track the tip orientation when inserted into the sinus. Note: If left-handed, the grip is reversed to accommodate the left hand.

 

 

 Instruction Line Drawings-03

Figure 1: Frontal Solid Dilator

 Instruction Line Drawings-04

Figure 2: Maxillary Solid Dilator

Instruction Line Drawings-05

Figure 3: Sphenoid Solid Dilator

Use the oval depth markings to prevent over-insertion of the Sphenoid Dilator into the sphenoid sinus of the patient, as shown in Figures 3 and 4.

Instruction Line Drawings-06

Figure 4:  Insertion of the Sphenoid Solid Dilator

SUCTION DILATOR USE

When using the Suction Dilators, hold the dilator in a pen-grip. To create suction hold the thumb over the bypass valve hole on the flat side of the dilator as show in Figures 5 and 6.

 Instruction Line Drawings-07

Figure 5: Frontal Suction Dilator

Remove the thumb from over the bypass valve hole to decrease suction in the sinus. Use the flat side to track the tip orientation when inserted into the sinus.

Instruction Line Drawings-08

Figure 6: Sphenoid Suction Dilator

 Instruction Line Drawings-09

Figure 7: Insertion of Sphenoid Suction Dilator

Use the oval depth markings to prevent over-insertion of the Sphenoid Suction Dilator into the sphenoid sinus of the patient, as shown in Figure 7.

o INSTRUMENT PROCESSING (then link to its own page)

o Processing must be performed using appropriate equipment, materials and personnel to achieve the desired result. This normally requires validation and routine monitoring of the process.

Sterilization temperature higher than 137° C (278° F) may damage the instruments.

To prevent corrosion stains:

? Avoid scratching the instruments.

? Avoid exposing instruments to water with high ionic content (examples:

? Avoid contact with chemicals or corrosive steams.

? Apply a suitable lubricant uniformly in the joints to protect against corrosion,

? Follow the cleaning and disinfecting instructions after each use.

Chlorine, iodine, fluorine, etc.). seizing and other instrument damage.

Before first use:

o Remove the instruments from their packaging and store in a dry place.

o Thoroughly clean new instruments before use to remove storage oils.

Limitations on Reprocessing:

Repeated processing has minimal effect on these instruments. End of life is normally determined by wear and damage due to use.

o HOW SUPPLIED

o Instruments are delivered non-sterile and must be cleaned and sterilized prior to each use.

o POINT OF USE CARE,/p>

o Keep instruments moist and do not allow blood and/or bodily fluids to dry on the

o Remove gross contaminants with a steady stream of cool water.

o Rinse each instrument thoroughly. Do not use saline or chlorinated solutions.

o Remove visible surgical residues using a lint-free wet wipe.

o CLEANING AND DISINFECTING

o These cleaning instructions are applicable to a range of Simplicity’s® Nasal Dilators instruments with different features. If a feature is not present on the instrument you are cleaning then the instruction is not applicable to the instrument.

o Initiate instrument cleaning within 30 minutes following use.

o Caution: Only use a soft brush or cloth to manually remove impurities; never use

o Perform the final instrument rinse with treated water that does not contribute to

o Ultrasonic cleaning may be used with either the manual cleaning or automated

o If an alkaline based detergent is used during the cleaning process, a neutralization abrasive materials as they may damage the instruments device staining or contamination. cleaning process. Follow the manufacturer’s recommendations solution may be used to remove alkaline-based residues and deposits. Follow the manufacturer’s recommendations.

 

Manual Cleaning:

Equipment: Personal protective equipment, enzymatic detergent, brush, non-metallic pipe cleaner, running water

1. Rinse instrument using cool running water to remove gross soil. A soft bristled brush may be used to aid in the removal of soil. Flush water through shafts, lumens, crevices, hard to reach areas and blind holes until exiting water runs clear.

2. Prepare an enzymatic detergent such as Enzol® per manufacturer’s recommendations. Fully immerse the instrument in the prepared detergent. Use a syringe filled with the prepared detergent to flush all shafts, lumens and blind holes to ensure the detergent solution reaches all areas. Allow instrument to soak for a minimum of three minutes.

3. Following the soak time, while still immersed, use a soft bristled brush or non-metallic pipe cleaner to thoroughly clean the instrument. Pay particular attention to lumens, blind holes, and all hard-to-reach areas. Use a syringe filled with the prepared detergent to flush all shafts lumens and blind holes until exiting detergent runs free from visible soil.

4. Remove the instrument from the detergent solution and rinse with running water. Use a syringe to flush water through all shafts, lumens and blind holes until exiting water runs clear.

5. Visually inspect each instrument for visible soil. If soil remains, repeat the cleaning procedure outlined above.

Automated Cleaning:*

General automatic washer instructions are provided below. Use the washer manufacturer’s recommendations for water level, cleaning agent concentration levels, and temperature.

Equipment: Personal protective equipment, washer/disinfector, enzymatic detergent

1. Rinse instrument using cool running water to remove gross soil. A soft bristled brush may be used to aid in the removal of soil. Use a syringe to flush water through all shafts, lumens, crevices, and hard to reach areas until exiting water runs clear.

2. Transfer the instrument into the automated washer. Load the instrument at an incline to ensure holes and lumens can drain.

3. The following minimum cycle has been validated to effectively clean the surgical instruments. Additional time and phases may be added.

manualcleaning

 

 

1. Remove instrument from washer, and visually inspect for visible soil. If soil remains, repeat the cleaning procedure outlined above.

* Simplicity® validated these cleaning methods using an independent accredited test laboratory and has the data on file. The validation was accomplished using Enzol® as the enzymatic detergent.

DRYING

Ensure the instruments are free from residual moisture prior to sterilization. If moisture remains on the instrument, dry using a clean lint-free cloth and/or filtered pressurized air.

WARNING: Failure to properly clean and dry the instruments may lead to inadequate sterilization or a reduction in instrument life.

INSPECTION & FUNCTIONAL TESTING

o Allow the product to cool to room temperature.

o After cleaning and disinfection, check that the product is dry, clean, operational and free of damage.

o Check instruments for distortion. Where instruments form part of a larger assembly, check the assembly with mating components. Remove instruments that are distorted or do not assemble well with mating components.

o Repeat cleaning and disinfecting for products that still show impurities or contamination.

o Sort out damaged or inoperative instruments for maintenance by Simplicity® (see WARRANTY section for details).

o After each cleaning, treat the instruments with lubricant suitable for steam sterilization.

STERILIZATION

o Sterilize instruments in sterilization trays and containers. Disposable sterilization packages may also be used.

o Ensure that all surfaces will be exposed to the sterilizing agent. Ensure that instruments do not contact each other if multiple instruments are packaged together.

o Control the water purity dedicated to steam production to prevent damage to the instruments.

o Sterilization temperatures higher than 137°C (278°F) may damage the instruments. To achieve a sterility assurance level of 10-6, use of one of the following sterilization parameters is recommended:

strerilization

 

 

* Simplicity® validated these sterilization cycles using an independent accredited test laboratory and has the data on file. The validation was accomplished with instruments wrapped together in two layers of 1-ply polypropylene wrap using sequential envelope folding techniques. Other sterilization cycles may be suitable; however, individuals or hospitals not using the recommended method are advised to validate an alternative method using appropriate laboratory techniques.

** Simplicity® validated these dry times using instruments wrapped together in two layers of 1-ply polypropylene wrap, weighing approximately 46g (1.6 oz.). Longer dry times may be required for instrument trays exceeding this weight.

STORAGE

o Store instruments in instrument trays or in a manner that prevents instrument damage.

o In sets: Instruments may be loaded into dedicated instrument trays or general-purpose sterilization trays. Do not exceed 7 kg (15.4 lbs) per tray. Wrap the trays using appropriate method.

o Shelf life of the sterile packaging is affected by its handling, storage location and wrapping materials.

MODIFICATION & MARKING

Unless prior written agreement is given, Simplicity® denies responsibility if modifications are made to these medical devices after distribution, except to comply with maintenance or sterilization requirements, such as given by the norms in force (laws, regulations, proper use, etc.). Any modifications to device identification or traceability by the user or a third party shall be subject to a prior written agreement with Simplicity®.

SERVICE & MAINTENANCE

Instrument service or maintenance should only be performed by Simplicity® or an authorized service facility. Maintenance or attempted repair by an unauthorized third party will void the warranty for these devices.