Widely Used Vaginal Speculums and there manufacturing process

Types of Vaginal Speculums and Their Uses

1. Cusco’s Speculum (Self-Retaining)

  • Design: The vaginal speculum is bivalve (duckbill shape), hinged in the center, opens like a beak.

  • Material: Stainless steel or plastic (disposable).

  • Use:

    • Routine pelvic examinations.

    • Pap smears.

    • Cervical inspection.

    • Intrauterine device (IUD) insertion.

    • Colonoscopy.

  • Advantage: Self-retaining, doesn’t require an assistant to hold.


2. Graves’ Speculum

  • Design: Bivalve with wider, curved blades than Cusco’s.

  • Use:

    • Suitable for parous women (those who’ve given birth).

    • Examination in obese patients.

    • Visualizing the vaginal walls and cervix.


3. Pederson Speculum

  • Design: Narrower blades compared to Graves’.

  • Use:

    • Ideal for nulliparous women or postmenopausal women with narrow vaginal canals.

    • Less traumatic for sensitive tissues.


4. Sims’ Speculum (Non-Self-Retaining)

  • Design: Single-blade, spoon-shaped.

  • Use:

    • Vaginal wall retraction.

    • Better access during surgeries (e.g., vaginal repair, prolapse).

    • Often used with an anterior vaginal wall retractor or tenaculum.

  • Advantage: Offers better visualization of the vaginal canal.


5. Auvard Weighted Speculum

  • Design: Heavy, single blade with weight to keep it in place.

  • Use:

    • Vaginal surgeries under anesthesia (e.g., hysterectomy).

    • Provides constant downward retraction.

  • Advantage: Hands-free due to weight.


6. Fergusson’s Speculum

  • Design: Tubular with no opening mechanism; simple cylinder.

  • Use:

    • Primarily for inspecting the vaginal canal or cervix.

    • Used in pediatric or postmenopausal women.

  • Advantage: Minimal discomfort, useful in sensitive cases.


7. Disposable Plastic Speculum

  • Design: Lightweight, single-use, usually similar to Cusco’s.

  • Use:

    • Pap smears and routine outpatient exams.

    • Clinics and mobile health camps.

  • Advantage: Hygienic, reduces cross-contamination.


Summary Table

Speculum TypeDesignKey UsesSelf-Retaining
Cusco’sBivalve, hingedPap smears, IUDs, routine examsYes
Graves’Bivalve, wider bladesParous women, better vaginal wall exposureYes
PedersonBivalve, narrow bladesNulliparous/postmenopausal womenYes
Sims’Single bladeSurgeries, posterior vaginal wall retractionNo
Auvard WeightedHeavy, single bladeVaginal surgeries under anesthesiaYes (by weight)
Fergusson’sTubularGentle inspection, pediatric casesYes
Disposable PlasticLightweight plasticRoutine exams, one-time useYes

 

Production Process :

 Vaginal Speculum — Rigor Instruments (Sialkot, Pakistan)

Below is the exact sequence we follow in-house, from concept to sterile-ready packaging. Every stage is ISO 13485–compliant and audited under our CE Technical File.

PhaseKey OperationsRigor-Specific Advantages
1. Design & Engineering• CAD modelling of blade curvature, pivot geometry, and ratchet spacing
• Finite-element stress simulation (handles & hinge)
• Rapid resin prototypes for hand-feel validation
• Dedicated R&D cell; 48-hour prototype turnaround
• All drawings stored in our proprietary PLM for full traceability
2. Raw Material Preparation• Medical-grade AISI 304 & EN 1.4301 stainless sheets (3 mm)
• PMI gun verification, lot-coded
• Direct mill contracts reduce impurity risk • In-house spectrometer archives heat numbers for 10 yrs
3. Forging / Blank FormingCold-forging presses create near-net blade blanks
• Press capacity = 250 T
• Unlike many Sialkot firms, forging is not subcontracted; tighter grain structure = higher fatigue life
4. CNC Milling & Turning• 5-axis machining refines beak profile, ratchet teeth, and hinge pin bore to ±0.02 mm
• Deburring robots on exit conveyor
• Tool offsets auto-logged; digital SPC charts flag drift in real time
5. Bending & Forming• Hydraulic benders set the 80° opening arc
• Match-gauges ensure bilateral symmetry
• Custom servo bender stores programs for each speculum size (S/M/L)
6. Laser Welding & Assembly• Fiber-laser welds hinge pin, locking screw, and spring
• Torque-tested to 15 N · cm
• Clean-room welding booth prevents oxide contamination
7. Surface FinishingGrinding: sequential 120 → 400 → 800-grit
Vibro-polishing: ceramic media 4 h
Electropolishing: Ra ≤ 0.2 µm
Optional Matte Sandblast (per customer spec)
• Fully enclosed dust-extraction on sandblaster
• Electropolish tanks use medical-grade phosphoric-sulphur mix for superior passive layer
8. Ultrasonic Cleaning & Passivation• Dual-tank ultrasonic line (40 kHz) with enzymatic detergent
• 20-min nitric passivation (per ASTM A967)
• Process water filtered to 0.2 µm; logged conductivity < 1 µS/cm
9. Quality Control• Dimensional check on CMM
• Hinge cycle test: 5,000 open/close cycles
• Roughness, radiography of welds, and spot salt-spray
• QA lab accredited to ISO/IEC 17025 • Batch records linked to UID laser mark on each instrument
10. Final Cleaning, Assembly & Pack• Final Class 8 clean-room rinse
• Silicone-free lubrication on hinge
• Individual Tyvek®/PET peel-pouch with IFU
• EO or plasma sterilisation validated to ISO 11135/11137 upon request
11. Shipping & Traceability• Cartons kitted with QR-coded labels for warehouse integration• Built-in blockchain ledger (optional) for end-user authenticity check
How This Differentiates Rigor Instruments
  • 100 % in-house workflow (forging, machining, finishing, cleaning) eliminates cross-site bio-burden risks.

  • Real-time SPC and digital batch records mean faster MDR/USFDA audit readiness.

  • Fine-grain cold-forged blanks reduce spring-fatigue failures by ≈ 18 % versus outsourced hot-stamped alternatives.

https://rigorinstruments.com/gynaecology-surgical-instruments/cusco-vaginal-speculum-c-screw/

 

 

 

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