Quick Start Guide
1. Description and intended use
The suture simulator is designed for practical training in basic suturing techniques on simulated tissue, using predefined wounds and, when necessary, new incisions created by the user.
It consists of:
- Rigid part: stable and reusable support base.
- Soft tissue with predefined wounds: a surface that mimics tissue, with different wounds already created in various areas to start suturing from the very beginning, and which allows for additional new incisions to be made.
- Basic suturing tools: standard instruments for practicing the technique.
Intended use: training and practice of suturing techniques in a simulation environment. It is not a medical device and is not intended for the diagnosis or treatment of patients.
Not suitable for use on humans or animals. Never use on real skin or in healthcare settings.
2. What's in the box
A standard suture simulator kit includes:
- 1 × rigid part of the simulator.
- 1 × soft tissue with predefined wounds.
- Basic set of suturing tools:
- 1 × scalpel handle.
- 1 × scalpel blade.
- 1 × needle holder.
- 1 × silk 2/0.
- 1 x scissors.
- 1 × tweezers.
Check the contents upon opening the box. If any item is missing, contact the supplier before first use.
3. Safety and warnings
Warning: The kit includes sharp materials (scalpel, scalpel blade, suture needle, and scissors).
- Handle all instruments with caution.
- Keep tools out of reach of unauthorized persons.
- Dispose of used scalpel blades in a suitable sharps container.
- Always use the simulator on a flat, stable surface and at a comfortable working height.
Forbidden:
- Use the simulator or tools on people or animals.
- Modify the rigid or soft part (cut the base, burn, glue, apply heat, etc.) beyond practice incisions.
- Do not use substances not listed in this manual on the soft tissue.
4. Before we begin
- Take out the hard part, the soft part, and the tools from the box.
- Place the rigid part on a table or stable surface.
- Verify that the soft part with predefined wounds is well seated on the base.
- If it arrives separated, fit it together following the geometry of the base until it is firm.
- Place the suturing instruments neatly in your workspace.
No additional setup is required to start practicing.
5. How to practice suturing
Detailed clinical instructions (types of points, techniques, sequences, etc.) are provided in the specific training materials associated with the simulator. Only the physical use of the device is described here.
5.1. Choose a predefined wound
- The soft tissue incorporates several predefined wounds in different areas .
- Select one of the wounds based on the training exercise.
- Consider its location, length, and orientation according to the teaching objective.
These wounds are designed so that suturing can begin without the need to create new incisions.
5.2. Optional: Create new incisions
- If your instructor, training program, or exercise allows it, you can create new incisions in areas of tissue not yet used.
- Use the scalpel with the blade mounted following the center's safety rules.
- Adjust the length and depth of the incision according to the desired level of difficulty.
- Avoid concentrating too many incisions in the same area so as not to compromise the stability of the material.
5.3. Suture the wound
- Use the needle holder, forceps, and 2/0 silk following the technique indicated by your teacher or clinical guide.
- Practice on predefined wounds and new incisions, replicating tissue manipulation in a simulated clinical environment.
5.4. Repeat and practice
- Each wound (predefined or created) is designed to accommodate multiple suture passes.
- As a reference, up to 10 uses per wound are recommended to maintain adequate material performance.
- When a particular wound is severely damaged, move it to another area or consider replacing the soft tissue.
5.5. At the end of the session
- Remove the sutures if necessary to prepare for new exercises, or leave them in place if they are to be used for evaluation.
- Remove the scalpel blade from the handle and dispose of the blade in a suitable sharps/cutting waste container.
- Store tools, rigid part and soft part, following the care and maintenance instructions.
6. Service life of the soft part (summary)
The soft part is considered to have reached the end of its useful life when:
- The predefined wounds and new incisions present wide tears that prevent proper suturing.
- It has noticeably lost elasticity or feel.
- The surface area available for new sutures is practically exhausted.
7. Manufacturer information
- Manufacturer: YSIUM MEDICAL SL
-
Address: Av. Irún, 26 bajo, 31194 Arre (Navarra)
- Web: ysiummedical.com
- Contact email: support@ysiummedical.com
Care and maintenance
1. Objective
This section describes how to clean, care for, store, and maintain the suture simulator to prolong its lifespan and preserve a realistic tactile sensation in both predefined wounds and areas where new incisions are made.
2. General recommendations
- Always handle the simulator with clean hands.
- Avoid blows, twists or sudden stretching of the soft tissue.
- Do not place heavy objects on top of the simulator during storage.
- When not in use, it is recommended to bag the soft part to protect it from dust and prevent it from losing its feel.
3. Cleaning the soft part
After each practice session (predefined wounds and new incisions):
- Remove any visible dirt or particles from the surface.
- Lightly dampen a cotton ball with a small amount of alcohol .
- Clean the surface of the soft tissue with gentle movements, without soaking it or aggressively pressing on the incisions.
- Let it air dry completely.
To regain proper sensation:
- Sprinkle a small amount of talcum powder onto the surface.
- Spread and remove the excess with a clean brush until no white residue is visible.
This process helps prevent the material from becoming sticky and maintains a pleasant and homogeneous feel.
4. Cleaning the rigid part and tools
Rigid part
- Clean with a soft cloth slightly dampened with water and, if necessary, a small amount of neutral soap.
- Dry with a clean cloth before storing.
Tools
- Clean and disinfect according to the center's or user's protocols.
- Avoid products that can corrode metals or damage handles and surfaces.
- Always dry after cleaning to reduce the risk of rust.
5. Products you shouldn't use
Do not use on soft tissue:
- Do not use bleach or products containing chlorine.
- Aggressive solvents or products (e.g., acetone).
- Abrasive or particle-based cleaners.
- Excessive amounts of alcohol.
- Water immersion: Do not immerse the soft part in water or other liquids.
Using these products may irreversibly damage the material and voids the warranty .
6. Storage
- Store the simulator in a dry, ventilated place protected from dust.
- Avoid prolonged exposure to direct sunlight and sources of intense heat.
- Avoid very humid environments.
- Do not place heavy objects on top of the simulator, especially on the soft part.
Specific recommendations:
- Store the soft part in a clean bag when not in use to protect it from dust and maintain its feel.
- Store the rigid part and tools in the box or container you normally use.
The simulator is designed for indoor environments with normal temperature conditions, such as a home, a classroom, or a healthcare facility.
7. Useful life and replacement
Soft tissue
- Designed to withstand multiple uses per suture area.
- Reference: up to 10 uses per wound as a guideline.
- Replace the soft part when:
- The predefined wounds and added incisions present tears that prevent proper practice.
- The texture has changed noticeably (very rigid or very sticky).
- There are no more areas suitable for new sutures.
Rigid part
- Indefinite shelf life under normal conditions of use and following these care instructions.
- Periodic inspection is recommended to detect possible cracks or structural damage.
8. Disposal and waste
- The soft and rigid parts are considered non-hazardous waste.
- You can dispose of them along with general waste, following local regulations.
- They are not intended for specific recycling streams; in the absence of alternatives, treat them as rejects.
Scalpel blades and other sharp objects must always be disposed of as special sharps/cutting waste, in accordance with the regulations of the environment of use.
Commercial guarantee
1. Scope of the warranty
This commercial warranty applies to the suture simulator (rigid part, soft part and tools) purchased from the manufacturer or its authorized distributors.
It covers manufacturing and material defects that appear under normal conditions of use, in accordance with the instructions in the Quick Start Guide and the Care and Maintenance document.
This guarantee is understood without prejudice to the rights you have as a consumer under current regulations.
2. Warranty period
Rigid part of the simulator
- Commercial warranty of 24 months from the date of delivery.
- It covers manufacturing and material defects under normal conditions of use.
Non-consumable tools and accessories
- Commercial warranty of 12 months from the date of delivery.
- It covers manufacturing and material defects.
Soft parts and consumables
- Warranty against manufacturing defects for the first 6 months from delivery.
- Wear and tear, especially beyond the reference of up to 10 uses per wound , is considered normal and is not covered.
3. What the warranty covers
If the product has a manufacturing defect within the warranty period and has been used according to the instructions, the manufacturer may, at its option:
- Repair the product, or
- Replace it with an equal or equivalent product, or
- Refund the amount paid when repair or replacement is not possible or would be disproportionate.
The specific option will be determined on a case-by-case basis after the product has been evaluated.
4. Warranty Exclusions
The following cases, among others, are excluded from the warranty:
- Damage resulting from incorrect, negligent or use other than that described in the manual.
- Damage from cleaning with non-recommended products (bleach, solvents, immersion of the soft part, etc.).
- Breakages caused by blows, falls, twists or improper storage (weight on top, extreme heat, prolonged sun exposure...).
- Product modifications or repairs performed by unauthorized personnel .
- Normal wear and tear of soft parts and consumables, especially when:
- The recommended usage guidelines are exceeded (for example, more than 10 uses per predefined or created wound).
- The soft part has clearly been used beyond its obvious lifespan.
- Use of the simulator or tools on people or animals, or in real clinical procedures.
5. Complaint procedure
If you detect a possible defect covered by the warranty:
- Stop using the simulator if the fault affects its safety or operation.
- Gather the following information:
- Name and contact details.
- Purchase date and supporting document (invoice, delivery note, order).
- Detailed description of the problem.
- Photographs or videos where the defect is visible.
- Contact the manufacturer or authorized distributor using the contact details provided with the product.
You will be notified if the product needs to be sent in for review. Once assessed, we will confirm whether the defect is covered by the warranty and the applicable solution (repair, replacement, or refund).
6. Limitation of liability
The simulator is intended exclusively for training and simulation . The manufacturer will not be liable for:
- Indirect damages, loss of profits or loss of data arising from the use or inability to use the product.
- Consequences arising from the use of the simulator outside the conditions described in this manual, especially if it is used on people or animals.
The simulator does not replace formal training or supervised clinical practice on real patients.
7. Manufacturer's data
- Manufacturer: YSIUM MEDICAL SL
-
Address: Av. Irún, 26 bajo, 31194 Arre (Navarra)
- Web: ysiummedical.com
-
Contact email: support@ysiummedical.com
Designed and manufactured in Navarra.
Registered trademark.
