VOLK IM-007 Optical Non-Contact Slit Lamp Lenses Instruction Manual

: June 4, 2024
: VOLK

Table of Contents

VOLK IM-007 Optical Non-Contact Slit Lamp Lenses
SPECIFICATIONS
INDICATIONS FOR USE
REPROCESSING
CLEANING
DISINFECTION
STERILIZATION
Contact Information
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VOLK IM-007 Optical Non-Contact Slit Lamp Lenses

INTENDED USE
The Volk Optical Non-Contact Slit Lamp Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp.

SPECIFICATIONS

Product| Magnification| Field of View| Working Distance| Laser Spot Magnification| Diameter| Anti-Reflective Laser Coating
---|---|---|---|---|---|---
60D| 1.15| 68° – 81°| 13 mm| 0.87| 31 mm| BBAR
Super 66®| 1.00| 80° – 96°| 11 mm| 1.00| 31 mm| BBAR
78D| 0.93| 81° – 97°| 8 mm| 1.08| 31 mm| BBAR
90D| 0.76| 74° – 89°| 7 mm| 1.32| 22 mm| BBAR
Super Field NC®| 0.76| 95° – 116°| 7 mm| 1.30| 27 mm| BBAR
Super VitreoFundus®| 0.57| 103° – 124°| 4 mm| 1.75| 23 mm| BBAR
Super Pupil XL®| 0.45| 103° -124°| 4 mm| 2.20| 19 mm| BBAR
Digital 1.0x Imaging Lens| 1.00| 60° – 72°| 12 mm| 1.00| 31 mm| UHE
Digital Wide Field| 0.72| 103° – 124°| 4.5 mm| 1.39| 30 mm| UHE
Digital High Mag| 1.30| 57° – 70°| 13 mm| 0.77| 27 mm| UHE

INDICATIONS FOR USE

To be used by a licensed physician in a method consistent with other ophthalmoscopic non-contact slit lamp lenses.
Using the parameters in the Specifications table above, carefully position the lens to the appropriate working distance from the cornea.
The 60D, 78D, and 90D lenses can be held with either surface facing the patient. The Super VitreoFundus®, Super Field NC®, Super Pupil XL®, Super 66®, Digital Wide Field, and Digital High Mag must be held with the tapered end facing the patient. The silver rim on the ring of the Digital 1.0x Imaging Lens is to be positioned towards the patient.
Volk’s BBAR Anti-Reflective Laser Coating is optimized for diagnostic imaging, as well as visible and near-infrared wavelength laser procedures (e.g. argon & diode).
Volk’s UHE Anti-Reflective Laser Coating is optimized for diagnostic imaging and visible wavelength laser procedures only (e.g. argon).
When calculating the spot size at the retina, the laser spot setting should be multiplied by the appropriate Laser Magnification Factor. Refer to the Specifications table to find the appropriate Laser Magnification Factor for the lens you are using.

CAUTION:
ANY SERIOUS INCIDENT THAT HAS OCCURRED IN RELATION TO THE DEVICE SHOULD BE REPORTED TO THE MANUFACTURER AND THE COMPETENT AUTHORITY OF THE MEMBER STATE IN WHICH THE USER AND/OR PATIENT IS ESTABLISHED.

REPROCESSING

WARNING:

A THOROUGH, MANUAL CLEANING PROCESS IS RECOMMENDED.
CORROSIVE CLEANING AGENTS (I.E. ACIDS, ALKALINES, ETC) ARE NOT RECOMMENDED. DETERGENT CLEANING AGENTS WITH NEUTRAL PH ARE RECOMMENDED.

REPROCESSING LIMITATIONS:
Repeated cleaning, disinfection, and sterilization have minimal effect on Volk Non-Contact Slit Lamp Lenses when processed according to instructions. End of the product’s life cycle is normally determined by wear and damage due to use.

PREPARATION AT THE POINT OF USE:

New or used, contaminated lenses must be cleaned.
Body fluids should not be allowed to dry on the device prior to cleaning. Remove excess body fluids.
Universal precautions for handling contaminated materials should be observed.
Instruments should be cleaned as soon as possible after use to minimize the drying of contaminants to the surface.
Devices should always be handled in an appropriate method to ensure contamination is not introduced to a recently cleaned, disinfected, and/or sterilized device.

PREPARATION BEFORE CLEANING:
The following cleaning, disinfection, and sterilization instructions are aided by not allowing contamination to dry on the lens surface. When possible, place the lenses in water or cover them with a damp cloth.

CLEANING

CLEANING:
Select the desired method of cleaning:

Method A:| Clean with a mild detergent and a clean, soft cotton cloth or swab. Clean lens surface in a clockwise direction to help prevent the loosening of the retaining ring within the housing. Do not use detergents containing Emollients (moisturizers).
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Method B:

| Clean the glass element with Volk Precision Optical Lens Cleaner (POLC) or a Volk LensPen®. Clean lens surface in a clockwise direction to help prevent the loosening of the retaining ring within the housing.

CAUTION: Do not use Volk’s POLC, or the Volk LensPen® on surfaces that contact the eye.

Method C:| 1. Prepare fresh enzymatic cleaner (e.g. Enzol) solution – 2 ounces per gallon using warm (~30 – 43°C) tap water.

2. Soak each device in solution for 20 minutes.

3. After soaking, brush knurled surface on device ring with a soft-bristle brush and wipe lens portion with a soft cloth until all traces of cleaner and soil are removed. Clean lens surface in a clockwise direction. Pay special attention to all crevices and other hard-to-reach areas. NOTE: Do not brush lens portion to avoid scratching; use soft cloth.

4. Thoroughly rinse devices in a room temperature tap water bath (not under running water) until all visible cleaner has been removed.

5. Transfer the device(s) to a freshly prepared enzymatic solution (per step 1 above) and sonicate for 20 minutes.

6. After sonication, thoroughly rinse device(s) in a room temperature tap water bath (not under running water) until all visible cleaner has been removed.

7. Inspect each device for remaining debris. If any is observed, repeat the cleaning procedure with freshly prepared cleaning solutions.

DISINFECTION

Follow Method A or Method C cleaning instructions.
Select one of the solution types from the table below:
DISINFECTANT| CONCENTRATION| MIN SOAK TIME| MAX SOAK TIME
---|---|---|---
Glutaraldehyde| 2% aqueous solution| 25 minutes| N/A
Sodium hypochlorite (5000 ppm NaCIO)| 9-parts water:1-part household bleach (5.25% NaCIO)| 25 minutes| 25 minutes
Cidex OPA| See Manufacturer’s Instructions| 12 minutes| N/A
Position the lens on its side, and then immerse the device completely in the selected disinfectant solution for the minimum soak time listed above (minimum of 20°C). Ensure to fill all lumens and hard-to-reach areas, and eliminate air pockets.
Rinse thoroughly in a room-temperature water bath (minimum of 20°C). Rinse by immersing the device completely for a minimum of one minute. Manually flush all lumens or other hard-to-reach areas with water. Agitate the device underwater, bring it above water level, then re-immerse. Repeat the rinse procedure two additional times using fresh water.
Dry with a soft, lint-free cotton cloth.

CAUTION:

ENSURE THE DEVICE IS COMPLETELY SUBMERGED IN THE DISINFECTANT SOLUTION FOR THE ENTIRETY OF THE RECOMMENDED OR DESIRED SOAK TIME. DO NOT ALLOW THE DEVICE TO BECOME UNSUBMERGED FROM THE DISINFECTANT SOLUTION.
EXTENDED EXPOSURE AND/OR EXPOSURE TO HIGHER CONCENTRATIONS OF SODIUM HYPOCHLORITE WILL RESULT IN ACCELERATED DEGRADATION OF THE PRODUCT.

STERILIZATION

Follow the Method C cleaning instructions.
Ethylene oxide sterilization is the preferred method of sterilization. Sterilize using a 2-hour cycle with a recommended temperature of 130°F (not exceeding 150°F) and a concentration of 600 mg/L.
Do not sterilize lenses within standard (black leatherette) lens cases as they are not meant for use in sterilization systems.

CAUTION:
TO AVOID PRODUCT DAMAGE, NEVER AUTOCLAVE OR BOIL LENSES OR ADAPTERS.

STORAGE:
Sterile instruments should be stored in an area that provides protection from loss of sterility.

DEVICE DISPOSAL
Disposal of this product in an unlawful manner may have a negative impact on human health and on the environment. Do not dispose of the lens as unsorted municipal waste. When disposing of this product, please follow the procedure which conforms with the laws and regulations applicable to your area.