2018

High Performance Productsfor Ophthalmologists

Ophthalmology

InstrumentsSurgicals

Consumables

About us

Iso Clear is a wholly-owned South African company supplying high quality, affordable ophthalmology products and solutions into the market, with superior levels of customer service and intimacy. We hold distributor rights in South Africa - and in some cases Africa - for a range of ophthalmology devices, surgicals and surgical consumables. We partner only with reputable and ethical international and local manufacturers.

Superior customer

service

Value Proposition The Iso Clear philosophy is “Superior Customer Service. Quality. Innovation”. We understand that our customers want quality products that are reliably available and are within budget. Our approach is to source or manufacture products that satisfy the purchase criteria of our customers as well as the user requirements of the end-users, the ophthalmic surgeons. All new products are formally evaluated by our dedicated Clinical Committee of ophthalmic surgeons, before being adopted into the Iso Clear product range.

Quality of products All products in our range have been designed and manufactured under a comprehensive quality management system for medical devices, and carry either the CE Mark or are FDA approved. Certificates of Quality can be produced upon request for all our products.

Quality

Innovation

Quality Management System Iso Clear itself will imminently be an ISO 13485 accredited firm, which means that we satisfy the requirements for a quality management system that can demonstrate our ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Brands and Suppliers

We are proud to partner with reputable international and local manufacturers and suppliers, which allows us to offer well-recognised, quality products and brands. These are some of our partners and the products we have access to:

Our Partners & Suppliers Products

Single-use knives, e.g. diamond knives. Refer also Accumtome catalogue.

Surgical cleaning eye wipes.

IOL injector systems; Irrigation/aspiration phaco handpiece.

Ophthalmic drapes.

Surgical latex gloves.

Vitreoretinal surgical products: e.g. Laser & LED light source machines; Laser probes; Endo illuminator probes

Viscosurgical devices; Cross-linking solutions; Ophthalmic dyes; Lubricating eye drops; Retinal stabilising adjuncts; Corneal protection.

Micro-surgical instruments; Various consumables. Refer also Rumex catalogue.

Scleral markers; Retrobulbar needles; Lachrymal needles; Viscuous fluid injection cannulas.

Disposable (single-use) ophthalmic knives; Eye shields; 26 g lachrymal cannulas.

Rycroft cannulas; Hydrodissection cannulas; Instrument wipes; Punctum plugs; Various consumables. Refer also Tecfen catalogue.

Surgical markers.

Intra-Ocular Lenses; Viscoelastics.

Contents

CoContents Page Link

Ophthalmic Knives/Blades 5

Phaco Instruments/Accessories 6

Vitreoretinal instruments/Accessories 7

Laser and Light (LED) Sources (Retinal Probes & Illuminators) 8

Cannulas and Needles 9

Microkeratome Blades and Tubing 12

Intraocular Lenses & Injectors 13

Surgical Consumables and Other 14 Ophthalmic Viscosurgical Devices 14 Corneal Collagen Cross-Linking Solutions 15 Corneal Epithelium Protection 16 Ophthalmic Surgical Dyes 16 Lubricating Eye Drops 17 Other 18

Ophthalmic and Lasik Drapes 20

Surgical Gloves (Latex, powder-free) 21

Appendix A: Summarised Listing of Iso Clear Products 23

Please note:

The items listed in this catalogue are typically kept in stock by Iso Clear. We have

distributor access to a wider range of ophthalmic surgical instruments and consumables

through, for instance through Rumex, Accutome and Tecfen. Their catalogues can be

viewed via these website links:

On-line catalogue Downloadable pdf catalogue

Rumex Website PDF file

Accutome Website PDF file

Tecfen Website PDF file

Ophthalmic Knives/Blades link to contents page

5

A range of single-use ophthalmic surgical cutting instruments.

‘Stab’ Knives and Collets 15°, 22.5°, 30°, 45° (Knives). 15° (Collet)

#0010017 Strong, true point for easy penetration during initial stab incision Nappi code: 179943001 (15° knife)

Crescent 2.0mm Knife or Collet Angled Bevel Up #0010018 Smooth scleral shelf to promote a self-sealing wound Minimal tissue drag and distortion. Bevel to compensate for curvature Nappi code: 179944001

Crescent 2.0mm Knife or Collet Straight #0010019 Smooth scleral shelf to promote a self-sealing wound. Minimal tissue drag and distortion Nappi code: 179945001

Phaco Slit Single Bevel Knife Angled 1.8mm; 2.0mm; 2.1mm; 2.2mm; 2.3mm; 2.4mm; 2.5mm; 2.65mm; 2.75mm; 2.8mm; 2.85mm; 3.0mm; 3.2mm; 3.5mm

#0010020 Precision slit knives penetrate easily while creating an accurate width incision for optimal fit to the phacoemulsification tip Nappi code: 179946001 (3.0mm)

MVR/Sideport Knives – Straight or Angled 0.9mm (20G); 1.1mm (19G); 0.6mm (23G); 0.8mm (21G); 0.5mm (25G)

#0010021 MVR / Sideport Knife - side cutting ability Nappi code: 179947001 (0.9mm (20G) Straight)

Phaco Instruments/Accessories link to contents page

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A range of single-use and re-sterilisable ophthalmic surgical instruments for phaco and anterior procedures.

I/A Handpiece #0110006 20G Coaxial Aspiration cannula angled 45° for incisions of 2.5mm Polished head Nappi code: 179942001

Phaco Tip Hypersonic 30° 19/20G #0110009

Made of high grade titanium. High-polish finish. Wide range of tip sizes and designs available Compatible with the majority of equipment and to cover traditional and bi-manual and coaxial micro-incision techniques Nappi code: 180163002

Tip-Wrench (non-sterile) #0110010 Stainless-steel Precise and efficient tightening and unscrewing of the tips Nappi code: N.A.

Sleeve 19G Blue Coolflow (non-sterile) #0110007 Available for 19G, 20G, 21G and 23G phaco tips For incisions of 2.8 mm to sub 2.00 mm Nappi code:180161002

Test Chamber Silicone (non-sterile) #0110008 Filled with irrigating solution Nappi code: 180162002

Vitreoretinal Instruments/Surgicals link to contents page

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A range of single-use and re-sterilisable ophthalmic instruments for vitreoretinal and posterior procedures.

One Step Trocar 23G #0140005 Trocar knife with preloaded trocar cannula – 3 pieces Self-sealing trocar cannula; 3 pieces; Infusion line – 1 piece; 5 sets per box; Disposable Nappi code: TBA

Illuminated Endolaser Probe Curved or Straight 20G, 23G, 25G, 27G #0140007a/b/c/d/e/f/g/h Nappi code: TBA

Endolaser Probe 23G Curved or Straight 20G, 23G, 25G, 27G

#0140006a/b/c/d/e/f/g/h Nappi code: TBA

Endoillumination Probe: Light Pipe or Wide Angle or Shielded 20G, 23G, 25G, 27G

#0140008a/b/c/d/e/f/g/h Nappi code: TBA

Chandelier

23G, 25G, 27G (double)

0140009 Nappi code: TBA

Laser and Light/LED Sources link to contents page

8

A range of compact machines for endolaser photocoagulation and ophthalmic LED light source.

Fenix 532 2-in-1 endolaser photocoagulation and ophthalmic LED light source. #140010

Compact green endolaser photocoagulation. New generation laser Thin-Disk technology. Highest beam quality. Quick power stabilisation in the ms-impulse regime. No peaks visible even in the on-off phase of the pulse. Programmable, user-friendly touchscreen menu. Maximum 3 watts power. LIO and SLT compatible. Compatible with 20G, 23G, 25G and 27G standard and illuminated Fenix endolaser probes

Ledix Ophthalmic LED Light Source #140011 2 Port illumination output. User-friendly touchscreen menu. No IR or UV. 50,000 hours lifetime. Real white light. Compatible with different tips of 20G, 23G, 25G and 27G chandeliers, illuminators & illuminated endolaser probes

Specifications

Laser source High Technology THINDISC efficiency laser Laser wavelength 532 nm green laser Laser power 3000 mW high power laser.

Software limited 1500mw for safety and longer lifetime Duration- interval pulse time 10ms to 3000ms Laser aiming beam 640 nm visible low power laser(10mw max) Laser cooling Air - tec cooling system with silent fan Delivery system With special Fenix endolaser probe connection Integrated Light source High power cool white led Led safety Temperature-controlled for longer lifetime Led cooling Silent fan cooling Size dimensions 310 mm x 120 mm x 291.7 mm (width x height x depth) Weight 4.6 kg Input power 100-240 Volt AC 50/60 Hz T 2.0 A fused Optional accessories SLT and LIO adaptors

Cannulas and Needles link to contents page

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A range of Cannula products, including: Anterior Chamber Irrigation, Anterior Chamber Maintenance, Capsule Polishing; Capsulotomy; Cortex Removal; Hydrodissection; Irrigation & Air Injection; Irrigation & Aspiration; Nucleus Removal.

Other types and dimensions are available, the following products are popular items.

Handle Backflush #0120001 For passive aspiration With finger control and luer lock cannula connection Nappi code: 180164001

Cannula Backflush #0120002 23G Extrusion Cannula for Passive Aspiration during Vitrectomy procedure Nappi code: 180165001

Cannula Straight Soft Tip #0120003 Soft tip for Vitreoretinal handpieces Silicone extends to 1mm beyond end of cannula Nappi code: 180166001

Cannulas and Needles link to contents page

10

Cannula Lacrimal 26g, curved #0130003 For insertion and irrigation of the nasolacrimal system Nappi code: 180168001

Anterior Chamber Cannula 27g 5mm bend #0020005 Nappi code: 168449001 Anterior Chamber Cannula 25g 5mm bend #0020012 Nappi code: 168451001

For maintaining the anterior chamber during surgery and keeping the cornea moist. For use to inject BSS, viscoleastics, Air or intraocular medication

Capsulorhexis Cystotome 27g #0020007 Angled tip for push or pull cutting during CCC (Continuous Curvilinear Capsulotomies). Nappi code: 168455001

Standard Retrobulbar Needle 25G x 11/2" (0.5x38mm) #0030020 For injecting anaesthetic into the sub tenon space and around the globe Nappi code: 247986001

Hydrodissection Cannula [Kellan] 27g x 22mm (7/8") curved #0020019 For separating posterior capsule and cortical attachments Smooth insertion and permits fanlike distribution of fluid for easier separation Kellan (Vertical plane) Nappi code: 201434001

Cannulas and Needles link to contents page

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Cannula Hydrodissection J-Shaped 25G/27G vertical flat tip #0020016 For separating posterior capsule and cortical attachments J-shaped flattened tip provides hydrodissection between the 10- & 12 o'clock position Nappi code: 179948001 (25G)

Cannula Anterior Chamber Maintainer 20G/23G Ribbed Open tip 20G/27G Smooth Tip #0020017 For maintaining & forming the anterior chamber during surgery by injecting or removing viscoelastic materials, BSS or air Nappi code: 179949001 (20G Ribbed)

Sub Tenon 19g 25mm x 1" curved flattened tip #0020004 Nappi Code: 168446001

Microkeratome Blades & Tubing link to contents page

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Mickrokeratome Blades #0010009 Compatibility: Zyoptix XP, Hansatome, Moria QE101 is Compatible Nappi code: 153039001

Tubing Tubing contains proper Keratome fittings with a moisture trap. Precision filter designed to capture moisture before it damages the Microkeratome console, increasing the lifespan of the device All tubing both sterile and disposable. #0050003 Moria Compatible #0050001 Hansatome compatible Nappi code: 180141001

Intraocular Lenses & Injectors link to contents page

13

IOLs and Lens Injector Systems Acriva®: Our premium, yet well-priced, monofocal IOL from Dutch-based VSY Biotechnology. Iso Clear is listed on Discovery Health’s approved supplier list of Monofocal and Toric IOLs.

IOLs and Lens Injector Systems

Intraocular Lens #UD 008ACR30 Diopter Sizes +3.0 to +31.0 Produced from an ultra pure acrylate monomer, selected for its 25% water content along with its water resistant hydrophobic surface UD Aspheric, Copolymer-Hydrophobic Surface, UV Filter, 13.0 mm diameter. Modified ‘C’ haptic Nappi code: Contact Iso Clear

Viscoject-Bio 2.7 Injector set Viscoject eco Injector-Set 2.7 for 1-piece lenses. Box of 20

#0080007 For incision sizes of sub 2.8 mm Nappi code: N.A.

#0080003 For incision sizes of sub 2.2 mm Nappi code: N.A.

Surgical Consumables link to contents page

14

A range of biotechnology products and solutions for ophthalmology: Ophthalmic Viscosurgical Devices; Corneal Epithelium Protection; Cross-linking Solutions; Ophthalmic Dyes; Eye Drops.

Ophthalmic Viscosurgical Devices Viscoelastic solutions for intraocular injection, used to make cataract surgery safer and easier by maintaining the deep anterior chamber, protecting ocular structures, and reduced trauma to the corneal endothelium and other ocular tissues. The viscoelastics are manufactured from purified sodium hyaluronate of high molecular mass, dissolved in a physiological buffer. A clear, sterile, non-pyrogenic, viscoelastic solution.

Protectalon Cohesive 1.0%, 1.2%, 1.4%, 1.6%, 1.8%, 2.0% #0190001a/b/c/d/e/f Supplied prefilled in glass syringes with 25g, bent tip, blunt cannula 1.1 ml syringe of 10mg, 12mg, 14mg, 16mg, 18mg or 20mg per ml sodium hyaluronate dissolved in physiological buffer Nappi code: 272654/001 (1.0% variant)

Protectalon Dispersive 3.0% #0190002 Supplied prefilled in glass syringes with 25 g, bent tip, blunt cannula 1.1 ml syringe of 30mg/ml sodium hyaluronate sodium hyaluronate. Dissolved in physiological buffer Nappi code: 272699/001

1.0% Cohesive displayed

Surgical Consumables link to contents page

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Corneal Collagen Cross-Linking Solutions A range of Riboflavin (vitamin B2) solutions, used with UV-A light as a corneal collagen cross-linking surgical treatment for corneal ectasia such as keratoconus, PMD, and post-LASIK ectasia. Applied to cornea to facilitate performance of ophthalmic cross-linking procedures using UV light to treat corneal disorders. Riboflavin solution acts as photosensitizing agent that releases free radicals (reactive oxygen) that result in cross-link formation on the collagen chains. Also protects the cornea from UV during procedure.

Ribotran #0060014 Standard Riboflavin Isotonic Solution with Dextran for epi-off procedures 1 preloaded glass syringe, 3.0ml Riboflavin (0.1%), Dextran (20%) Nappi code: 211077001

Ribotran Iso (for epi-off) #0060012 1 preloaded glass syringe, 3.0ml. Riboflavin (0.1%), HPMC (1.0%) Nappi code: 211080001

Ribotran Hypo (for corneal swelling) #0060013 Hypotonic solution for corneal swelling. If corneal thickness is under 370 μm, corneal thickness must be increased by means of Ribotran-hypo to ensure endothelial safety 1 preloaded glass syringe, 2.0ml Riboflavin (0.1%) Nappi code: 211079001

Ribotran TE (for epi-on) #0060015 Transepithelial solution for epi-on procedures No removal of corneal epithelium necessary 1 preloaded glass syringe, 2.0ml Riboflavin (0.25%), HPMC (1.0%), BAC (0.007%) Nappi code: 211082001

Surgical Consumables link to contents page

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Corneal Epithelium Protection Ophthalmic solution to hydrate and protect the cornea during ophthalmic procedures. This ophthalmic solution eliminates the need for frequent interruptions to irrigate with BSS because of the longer hydration duration provided by this product. It advances comfort during surgery. This ophthalmic solution also protects the corneal epithelium from being injured, which commonly occurs when using BSS.

VisiProtect #0060010 A sterile, pyrogen free, viscoelastic solution of highly purified, non-inflammatory hydroxypropyl methylcellulose (HPMC) solution A prefilled glass syringe (2ml) and one sterile cannula for single use Hypromellose (2%), Sodium Chloride, Phosphate buffered saline Nappi code: 211086001

Ophthalmic Surgical Dyes for Vitreous and Membranes Trypan blue (stains the anterior capsule and fibrous tissue) and Brilliant blue (stains of the Inner Limiting Membrane (ILM) and epiretinal membranes).

TryBlue-S #006006 A sterile, pyrogen-free solution. 1 preloaded glass syringe, 2.0ml and one sterile cannula for single use Tryphan Blue (0.10 %), Sodium Chloride, Mannitol, Phosphate Buffered Saline, Aqua Nappi code: 211084001

DuoBlue #006007 A sterile, pyrogen-free solution. 1 preloaded glass syringe, 2.0ml and one sterile cannula for single use Tryphan Blue (0.1 %), Brilliant Blue (0.05 %), Sodium Chloride, Mannitol, Phosphate Buffered Saline, Aqua Nappi code: 211083001

Surgical Consumables link to contents page

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Lubricating Eye Drops Solutions that lubricate and moisten the delicate tissue of the eye, with unique combinations of ingredients that coats and re-coats the surface of the eye for continued relief of dry, irritated eyes. Contain no damaging chemicals, and provides instant and continued comfort with fewer applications required.

VisiTears #0060008 Indications: Irritated eyes; Burning, itching eyes; Tired eyes; Morning dry eyes; End-of-day dry eyes; Night-time dry eyes; Discomfort and vision problems related to Computer Vision Syndrome Supplied prefilled in a white dropper bottle (15 ml) Sodium carboxymethylcellulose (0.5%), Glycerine, Sodium Chloride, Phosphate Buffered Saline, Aqua, SOC as preservative. Nappi code: 211085001

VisiTears Ultra #0060009 For relief and protection from dry eye symptoms Supplied prefilled in a green dropper bottle (10ml) Sodium Hyaluronate (0.1%), Sodium carboxymethylcellulose (0.5%), Glycerine, Erythritol, Phosphate Buffered Saline and SOC as preservative. Nappi code: 272653/001

Surgical Consumables link to contents page

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Other Consumables Instrument Wipe 7.6cm x 7.6cm x 1mm #0040004 1Pack with 20/box – Sterile Nappi code: 999999999

Blefavis Cleansing Wipes #0040008 Cleaning and disinfectan wipes for the eye zone An innovative product made by soaked wipes in liquid specifically designed for the daily cleaning of the sensitive and seborrheic eyelids and eyelasheNappi code: 999999999

Eye Shields Clear Sterile #1000002 Lightweight polycarbonate shields for post-operative use Nappi code: 180172001

Spears surgical PVA lint free #0040007 Sterile, Lint free and super absorbent Nappi code: 180139001

Bio Glo Fluerecein Sodium #0150001 Fluorescein Sodium Stips(100/box) for Dry Eye Diagnostics Nappi code: 180169001

Sterile pre-loaded punctum plugs 0.7mm; 0.8mm; 0.9mm #0170001; #0170002; #0170003 Nappi code: 217797001; 217798001; 21799001 Longterm relief from dry-eye syndrome.Inserted into punctal opening to block tear drainage through the canaliculus.

Surgical Consumables link to contents page

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Lacrimal Punctum plugs (0.5mm), Medium Term, Dissolvable #0170004 Absorbable Punctum Plugs provide occlusion therapy of the lacrimal drainage system lasting approximately 180 days. Lacrisolve® 180 is intended to temporarily treat the symptoms of dry eye disease, contact lens intolerance secondary to dry eye, and to increase efficacy of ocular medications and lubricants Nappi code: 261219001

Surgical Skin Marker #1000001 Sterile, single use, Scrub resistant Gention Violet Ink. Packaged with 15cm ruler. Nappi code: 168439001

Scleral Marker (3.5/4.0mm) #0180004 80cm long and designed to be used as part of the intravitreal injection procedure for treatment of AMD. Two calibrated markers (3.5/4mm) to mark the injection point Nappi code: 257016001

Cautery High Temp #01100001 High temperature cauteries are popular for many types of procedures including pinpoint hemostasis, evacuation of a subungual hematoma, controlling diffuse bleeders, vasectomies, and sculpting woven grafts Nappi code: 26122001

Cautery Low Temp #01100002 Low temperature cauteries are popular for many types of procedures including pinpoint hemostasis. Nappi code: TBA.

Ophthalmic Drapes link to contents page

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Ophthalmic drapes custom-manufactured for Iso Clear and its clients.

Ophthalmic Drape with no aperture For cataract surgery #0090007 MS1004 45cm (L) x38cm (W) Adhesive size: 14cm x 18cm Nappi code: 207176001

Ophthalmic Drape with Aperture For cataract surgery #0090006 MS1005 45cm (L) x38cm (W) Adhesive size: 14cm x 18cm Nappi code: 207175001

Ophthalmic Drape For Posterior Surgery (Ex. PPV; Retinal) Double Pouch, No aperture Adhesive: 14cm x 18cm #0090011 MS1007 Nappi code: 266293001

Lasik Drape #0090010 MS 6007 Mainly Lasik procedures in Theatre Incise Size: 15cm (L) x 10 cm (W) Nappi code: 249326001

Shape/colour legend:

Latex Surgical Gloves (powder free) link to contents page

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Adopted by ophthalmic surgeons across the UK. Now available in South Africa. Founded in 2013 by the former leadership team of the world’s most favoured brand of surgical gloves for the past 40 years, Leanvation® have made a huge impact already in the United Kingdom.

Leanvation® Eco glove Sterile, powder-free latex surgical glove suited to a broad range of surgical specialties. Thickness:

• Finger 0.20mm

• Palm 0.18mm

• Cuff 0.14mm

Leanvation® Sensitive glove Sterile, powder-free latex surgical glove suited to surgical procedures demanding extreme levels of grip and heightened resistance to puncture. Thickness:

• Finger 0.24mm

• Palm 0.22mm

• Cuff 0.21mm

Leanvation® Senstex Sterile, powder-free latex surgical glove suited to surgical procedures demanding heightened levels of tactile sensitivity and comfort. Thickness:

• FInger 0.20mm

• Palm 0.18mm

• Cuff 0.16mm

Latex Surgical Gloves (powder free) link to contents page

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Leanvation® Eco

Innovation that delivers paradigm change in pricing and quality.

The outcome of a quest to deliver maximum performance at minimum cost.

Incremental changes, ranging from the use of generic chemical components, single

colour & more compact packaging, and design changes that include a reduced length

cuff, add up to deliver a huge cost saving. Suited to all surgical procedures, Leanvation®

Eco offers the potential for huge rationalisation, glove standardisation and reduced

costs, while delivering improvements in clinical standards.

Leanvation® Senstex The ultimate in tactile sensitivity and comfort. Made from Leanvation’s softest polymer formulation, Leanvation® Senstex can be worn much closer to the skin than comparative gloves, affording wearers unparalleled levels of tactile sensitivity and control. 100% inspection, means every single pair of Leanvation® Senstex is electronically inspected for freedom from holes and defects.

Leanvation® Sensitive

Exceptional grip when you need it.

A slightly thicker variant of the Leanvation® Senstex, modified to offer extreme levels

of grip. Wearers accustomed to extremely high grip variants of competitor products

will experience even greater levels of control, yet will also be afforded a significant

upgrade in comfort and tactile sensitivity owing to the same polymer formulation as

Leanvation® Senstex.

Appendix A link to contents page

Summarised Listing of Iso Clear Products 23

Our goal is to deliver on our philosophy of:

Quality, Innovation and

Superior Customer Service

Iso Clear (Pty) Ltd.

BioParkMark Shuttleworth Street

The Innovation HubTshwane, South Africa

Tel: Ursula: 074 119 6057Tel: Craig: 082 410 7046E-mail: info@isoclear.netWeb: www.isoclear.net

.