Bone Cement | Fillers User Manual 

1. Introduction

About Jindal Medi Surge

Jindal Medi Surge is a leading manufacturer of high-quality orthopedic products, including bone cement, designed to enhance surgical outcomes and patient recovery. Our bone cement is formulated to provide strong, durable fixation of orthopedic implants.

Purpose of the Manual

This manual serves as a comprehensive guide for the proper use, handling, and storage of Jindal Medi Surge orthopedic bone cement. It is intended for healthcare professionals, including orthopedic surgeons, nurses, and other medical staff involved in orthopedic procedures.

Overview of Orthopedic Bone Cement

Orthopedic bone cement is a crucial material used in various orthopedic surgeries to anchor implants to the bone. It is commonly used in joint replacement procedures, such as hip and knee arthroplasties, to ensure the stable fixation of prosthetic components.

2. Safety Information

General Safety Instructions

• Ensure that all surgical staff are trained in the use of orthopedic bone cement.

• Follow the instructions for use carefully to avoid complications.

• Handle bone cement in a well-ventilated area to prevent inhalation of fumes.

• Avoid skin contact with uncured cement, as it can cause irritation or burns.

Indications and Contraindications

Indications:

• Joint arthroplasty procedures, including hip, knee, shoulder, and elbow replacements.

• Fracture fixation using bone cement-augmented implants.

• Revision surgeries where bone stock is compromised.

Contraindications:

• Patients with known hypersensitivity to any of the components of the bone cement.

• Severe vascular insufficiency in the area of application.

• Active infection at the surgical site.

Warnings and Precautions

• Avoid exposure to excessive heat during storage, as this can affect the properties of the cement.

• Do not use bone cement that appears discolored, hardened, or has an unusual odor.

• Ensure that the mixing process is completed within the specified time to avoid premature setting.

• Dispose of any unused cement according to local regulations.

Handling and Storage Guidelines

• Store bone cement in a cool, dry place away from direct sunlight.

• Keep bone cement out of reach of unauthorized personnel and children.

• Follow all local regulations for the safe disposal of bone cement and its components.

3. Product Description

Composition of Bone Cement

Jindal Medi Surge orthopedic bone cement is composed of a polymethylmethacrylate (PMMA) base, which is mixed with a liquid monomer to create a dough-like material that hardens upon curing. The cement may also contain radiopacifiers and antibiotics, depending on the specific formulation.

Types and Variants

Jindal Medi Surge offers several types of bone cement to meet the diverse needs of orthopedic surgeries:

• Standard Bone Cement: Designed for general orthopedic applications.

• Antibiotic-Loaded Bone Cement: Contains antibiotics to help prevent post-surgical infections.

• Radiopaque Bone Cement: Includes radiopacifiers for enhanced visibility under imaging.

Packaging and Storage

Bone cement is supplied in sterile, pre-measured packages that include separate containers for the powder and liquid components. The packaging is designed to maintain sterility until the cement is ready to be mixed and used.

4. Preparation and Application

Preoperative Preparation

• Ensure that all components of the bone cement are available and within their expiration dates.

• Prepare the surgical area and ensure all instruments are sterile.

• Familiarize yourself with the specific type of bone cement being used and its preparation requirements.

Mixing Instructions

1. Powder and Liquid Components: Open the sterile packaging and transfer the powder and liquid components to a clean, dry mixing bowl.

2. Mixing: Using a spatula, mix the powder and liquid components thoroughly until a homogeneous mixture is achieved. This process should take approximately 30-60 seconds, depending on the type of cement.

3. Working Time: The cement will reach a dough-like consistency within 2-3 minutes, providing a working time of approximately 6-8 minutes before it begins to set.

Application Techniques

• Implant Fixation: Apply the mixed cement to the prepared bone surface or implant, ensuring even coverage.

• Cement Pressurization: Use pressurization techniques as necessary to ensure proper filling of bone cavities and secure fixation.

• Final Setting: The cement will harden within 10-12 minutes, providing stable fixation for the implant.

Postoperative Care

• Monitor the patient for signs of infection, cement loosening, or other complications.

• Follow the surgeon's recommendations for postoperative care, including weight-bearing restrictions and physical therapy.

5. Maintenance and Handling

Storage Instructions

• Store bone cement in its original packaging at a temperature of 15-25°C (59-77°F).

• Avoid exposure to moisture, as this can compromise the integrity of the cement.

• Do not freeze the bone cement, as this can alter its properties.

Handling of Bone Cement

• Handle bone cement with care to avoid contamination.

• Wear appropriate protective equipment, such as gloves and masks, when mixing and applying bone cement.

• Use bone cement only within the specified working time to ensure proper curing and fixation.

6. Troubleshooting

Common Issues and Solutions

• Cement Setting Too Quickly:

  • Ensure that the mixing process is completed within the specified time.

  • Store bone cement at the recommended temperature to avoid accelerated setting.

• Cement Not Setting:

  • Verify that the correct proportions of powder and liquid were used.

  • Ensure that the components were thoroughly mixed.

• Implant Loosening:

  • Apply sufficient cement and use pressurization techniques to achieve proper fixation.

  • Ensure that the bone surface is adequately prepared before applying the cement.

Contact Information for Technical Support

For assistance, contact Jindal Medi Surge at:

• Email: info@jmshealth.com

• Website: www.jmshealth.com

7. References

Clinical Studies and Literature

• A selection of clinical studies and peer-reviewed articles supporting the use of Jindal Medi Surge orthopedic bone cement in various surgical applications.

Regulatory and Compliance Information

• Details on regulatory approvals and compliance with international standards for medical devices and bone cement.

For further details or inquiries, please contact Jindal Medi Surge using the provided contact information. We are committed to supporting you in delivering the best care to your patients.