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Gynaecological examination simulator (unversal) - 1000504

Product ID: ITM-1000504
generic
Training simulator intended for use in clinical, academic, and skills-based training environments for gynaecological examination and procedures, including diagnostic assessment and procedural practice.

Neutral / Universal complexion.

Material and constructionLatex-free construction.
Manufactured from medical-grade silicone rubber and/alternative plastics may be used if specified.Materials shall be:
Durable
Non-toxic
Free from hazardous or restricted substance
Safe for contact with skin. Any hinges, joints, or movable components shall be: Non-corrodible & Manufactured from materials suitable for repeated training use. Materials used shall allow for safe cleaning and disinfection.

Design and Functional Features.
Anatomically representative adult female torso model, including abdomen, external genitalia, and internal reproductive organs.Anatomical landmarks suitable for realistic hands-on gynaecological training.Interchangeable or modular components allowing simulation of normal and pathological conditions.The simulator shall support training in the following minimum scenarios and procedures:Cervical Examination
Simulation of a normal cervix, including compatibility with vaginal speculum insertion.
Simulation of cervical abnormalities or pathology, using interchangeable or dedicated components.Uterine Assessment
Simulation of a normal uterus.
Simulation of uterine abnormalities.
Simulation of a gravid uterus corresponding approximately to mid-pregnancy (around five months of gestation).
Simulation of ectopic pregnancyFallopian Tube and Reproductive Tract
Simulation of fallopian tube obstruction.Contraceptive Procedures
Capability to practice intrauterine device (IUD) insertion.Modular Anatomy
Supplied with a set of multiple uterus models representing normal and abnormal conditions.
Supplied with a set of multiple cervix models representing normal and pathological conditions.
The exact number and type of models to be specified by the manufacturerAdditional educational features may be included as specified by the manufacturer.

Supplied withInstructions for use, including:
Assembly
Operation
Cleaning and disinfectionInstructions provided in:
English
French
Spanish. Consumables required for routine use (e.g. talcum powder or equivalent), if applicable, should be specified by the manufacturerOne (1) carrying or storage caseAny additional accessories required for full functionality shall be listed.

Operating and Environmental Conditions.
Storage and transport conditions:
Temperature range: approximately 0°C to 50°C
Relative humidity: up to 90%Operating conditions:
Temperature range: approximately 10°C to 40°C
Relative humidity: up to 90.
Minimum warranty period: 2 years.
Expected product lifespan under normal training conditions: to be specified by manufacturer.
Guidance for disposal, recycling, or recovery at end of product life shall be provided in accordance with applicable environmental and waste management regulation.

Safety, performance and quality standardsCertified quality management system:
Mandatory: ISO 9001
Preferable: ISO 13485, or good manufacturing practice (GMP) for anatomical models.
Risk management ISO 14971 (by analogy).
FSC or Certificate for exportation of the offered product provided by the authority in the manufacturing country.
Compliance with ISO 10993-1 if appropriate
Material safety Declaration: REACH / non-toxic / latex free.


Pack SizeAvg. Price
Each$412.27