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PEAK SURGICALS
رمز التخزين التعريفي:PI-020
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معتمد من قبل CE
معتمد من إدارة الغذاء والدواء (FDA)
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Fansler-Ives Rectal Speculum, SKU PI-020, is a reusable manual proctology instrument manufactured from German stainless steel for controlled access to the anal canal and distal rectum. The pattern measures 3 1/4 inches (83 mm) in length with a 1 1/8 inch (28 mm) outer diameter and is supplied with a removable rounded obturator that closes the distal opening during insertion. The tubular body maintains a fixed viewing corridor after the obturator is withdrawn, while the lateral handle gives the operator leverage for stabilization, rotation, and staged withdrawal. Its open distal profile permits direct inspection of hemorrhoidal cushions, fissure margins, fistulous openings, postoperative tissue, and visible lower rectal mucosa. Colorectal surgeons, general surgeons, proctologists, and gastrointestinal procedure teams use this configuration during anoscopy, proctoscopy, internal hemorrhoid assessment, anal fissure evaluation, fistula workup, lower rectal bleeding assessment, targeted biopsy access, and postoperative review after hemorrhoidectomy, fistulotomy, fissure surgery, or local anorectal procedures. The instrument is suited to colorectal clinics, ambulatory surgery centers, operating rooms, and hospital procedure suites where a reusable rigid rectal speculum with obturator-guided insertion is required.
The Fansler-Ives pattern works through a short rigid tube rather than a pair of expanding blades. Before introduction, the rounded obturator is seated inside the barrel so the distal opening is covered by a smooth leading profile. This geometry reduces the likelihood that mucosa will enter the tube or catch against the metal edge while the assembly passes through the anal canal. Once the desired depth is reached, the obturator is withdrawn and the lumen becomes an unobstructed channel for direct vision, swabbing, suction, or passage of slender biopsy instruments. The cylindrical wall maintains local separation of the anorectal tissues without requiring a ratchet, screw spreader, or self-retaining blade mechanism. A broad proximal flange acts as an external depth reference and helps keep the entry opening accessible during inspection. The lateral handle projects away from the viewing axis, allowing the surgeon to rotate the instrument toward a target quadrant, stabilize it during examination, and withdraw it in controlled increments. The 28 mm outer diameter provides a wider field than narrow anoscopes while the 83 mm length keeps the working corridor compact. Together, the obturator, fixed tube, flange, and handle create a simple manual system for focused anorectal visualization and minor instrumentation.
For routine anorectal examination, the lubricated speculum is introduced with the obturator fully seated until the distal end reaches the required level. The insert is then removed and the surgeon inspects the anal canal, dentate-line region, hemorrhoidal columns, and accessible lower rectal mucosa while rotating the tube and withdrawing it in stages. During internal hemorrhoid assessment, the fixed lumen allows direct evaluation of prolapse, vascular congestion, friability, ulceration, and recent bleeding. For anal fissure inspection, the barrel can be oriented toward the affected wall so the fissure base, sentinel tissue, and adjacent mucosa are visible without repeated manual retraction. In fistula workup, the same exposure can assist identification of an internal opening before probing or definitive treatment. Lower rectal bleeding can be assessed for hemorrhoidal, traumatic, postoperative, inflammatory, or focal mucosal sources visible within the working range. A compatible swab or slender biopsy forceps can be passed through the lumen when targeted sampling is indicated. After hemorrhoidectomy, fistulotomy, fissure surgery, or local lesion treatment, the Fansler-Ives pattern can also support postoperative inspection for persistent bleeding, scar formation, narrowing, delayed healing, or recurrent anorectal pathology.
This listing uses the established 3 1/4 inch long x 1 1/8 inch outer-diameter configuration, equivalent to approximately 83 x 28 mm. The 83 mm tube length provides more reach than very short anoscopes while remaining compact enough for routine examination of the anal canal and distal rectum. Its 28 mm external diameter creates a substantial visual corridor for adult anorectal assessment and provides room for compatible suction, swabs, or slender biopsy instruments after the obturator is removed. The rounded obturator is the insertion component and should remain seated while the instrument crosses the anal verge so the open distal rim does not lead against the mucosa. The tube body is the exposure component, maintaining a fixed circular field after positioning. The proximal flange provides the external reference for depth and orientation, while the lateral handle supplies rotational control during quadrant-by-quadrant inspection. Unlike multi-size systems, this product is supplied as one defined geometry, so selection is based on the clinical need for an 83 mm working length and 28 mm outside diameter rather than a choice among caliber variants. It is best matched to adult proctology workflows requiring a rigid, obturator-guided viewing channel rather than mechanical dilation with a bivalve or three-prong speculum.
German stainless steel provides the structural rigidity needed to preserve the tube geometry during repeated insertion, rotation, cleaning, and sterilization while supporting corrosion resistance in hospital reprocessing workflows. The polished finish creates smooth patient-contact and internal surfaces that reduce drag during introduction and facilitate removal of blood, mucus, lubricant, and tissue residue after use. Reprocessing begins by separating the obturator from the speculum body, followed by thorough cleaning of the lumen, distal edge, flange, handle junction, and obturator surfaces. The channel should be brushed and flushed, then all components rinsed, dried completely, and inspected for retained debris, roughness, deformation, or altered fit before packaging. Reusable stainless-steel components can then undergo a validated steam-autoclave cycle appropriate to the device and the facility's sterile-processing protocol. CE marking supports applicable conformity documentation for regulated medical-device markets, while ISO 13485 identifies the quality-management framework governing controlled manufacture, traceability, and documentation. For United States purchasing, FDA-compliant procurement requires the relevant establishment, device, labeling, import, and supplier records applicable to the transaction. Peak Surgicals supports institutional ordering with a one-year warranty, single-piece MOQ, OEM or private-label supply, and return or replacement after-sale service.
| SKU | PI-020 |
|---|---|
| Product Name | Fansler-Ives Rectal Speculum |
| Price | $34.80 USD |
| Size/Gauge Variants | 3 1/4" (83 mm) long x 1 1/8" (28 mm) outer diameter |
| Instrument Category | Proctology Instruments / Rectal Speculums and Anoscopes |
| Procedure | Anoscopy, proctoscopy, internal hemorrhoid assessment, anal fissure inspection, fistula evaluation, lower rectal bleeding assessment, biopsy access and postoperative review |
| Material | German stainless steel |
| Finish | Polished stainless-steel finish |
| Sterilization | Reusable and compatible with validated steam-autoclave processing |
| Instrument Classification | Reusable manual rectal speculum with removable obturator |
| Reusable | Yes |
| Certifications | CE marked, ISO 13485 quality system, FDA-compliant procurement documentation |
| Warranty | 1 year |
| MOQ | 1 piece |
| OEM / Custom Orders | Available for hospitals, distributors and private-label procurement |
| After-Sale Service | Return and replacement support |
How does the Fansler-Ives Rectal Speculum differ from a Hirschman Anoscope? The Fansler-Ives Rectal Speculum uses a 28 mm outer diameter and an 83 mm tube to provide a comparatively broad fixed viewing corridor. A Hirschman Anoscope is available in narrower diameter and different length-and-bevel configurations for more targeted anal-canal examination. Both designs use an obturator-guided insertion approach rather than mechanically expanding blades. The Fansler-Ives pattern is selected when the clinician wants a wider tubular field and compact distal rectal access. Hirschman models provide more flexibility in matching tube diameter, working length, and bevel geometry to the target anatomy. Selection therefore depends on required lumen caliber, examination depth, and the amount of direct wall exposure needed.
Why is the 83 x 28 mm Fansler-Ives configuration selected? The 83 mm length provides enough reach for the anal canal and accessible distal rectum while remaining shorter than extended rigid proctoscopes. The 28 mm outer diameter creates a wider working corridor for adult examination and passage of compatible swabs, suction tips, or slender biopsy instruments. This size is useful during internal hemorrhoid assessment, fissure evaluation, fistula workup, and lower rectal inspection where broader direct visualization is desired. A narrower anoscope can be selected when reduced caliber is clinically preferable, while a longer proctoscope is chosen when more proximal rectal reach is required. The Fansler-Ives Rectal Speculum therefore occupies a middle position between compact narrow anoscopes and long rigid proctoscopes. Selection should reflect the planned depth, patient anatomy, and amount of accessory access required.
What do CE, ISO 13485 and FDA requirements mean for procurement? The Fansler-Ives Rectal Speculum is supplied within Peak Surgicals' CE and ISO 13485 procurement framework. CE marking supports applicable conformity documentation for regulated medical-device markets. ISO 13485 identifies the quality-management system governing controlled manufacture, traceability, documentation, and supplier processes. FDA procurement context for United States buyers concerns the relevant establishment, device, labeling, import, and distribution records applicable to the transaction. Hospitals and distributors should retain these documents within vendor qualification, purchasing, and audit files. These regulatory frameworks address distinct compliance functions and should be reviewed separately during institutional sourcing.
How are the rounded obturator and lateral handle used during the procedure? The rounded obturator is seated inside the tube before insertion so the open distal rim does not lead directly against the anorectal mucosa. Once the Fansler-Ives Rectal Speculum has reached the intended depth, the obturator is removed to expose the lumen for direct visualization and accessory passage. The lateral handle then provides leverage for stabilization, controlled rotation, and stepwise withdrawal. Rotational movement allows the clinician to inspect different mucosal quadrants without repeatedly removing and reinserting the device. The proximal flange remains outside the canal as a depth and orientation reference. There is no ratchet or expansion lock because exposure is produced by the fixed cylindrical lumen rather than a mechanical spreading system.
How should hospitals clean and sterilize the Fansler-Ives Rectal Speculum? The instrument should enter a validated reusable-device reprocessing pathway immediately after use. The obturator must be separated so the lumen, distal rim, flange, handle junction, and insertion component can be cleaned thoroughly. Blood, mucus, lubricant, and tissue residue should be removed before the channel is brushed and flushed, followed by complete rinsing and drying. Staff should inspect the tube for deformation, rough edges, corrosion, and correct obturator fit before packaging. Reusable stainless-steel components can then undergo a validated steam-autoclave cycle appropriate to the device and the hospital's sterile-processing protocol. Procurement teams should retain SKU PI-016, warranty documentation, certification records, supplier information, and service history for traceable inventory management.