Double Valve MVA Kit

Name: Double Valve MVA Kit - Amaris Medical Solutions
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A Double Valve MVA Kit (Manual Vacuum Aspiration) is a sterile, hand-held uterine aspiration system designed for early pregnancy termination, incomplete miscarriage management, and endometrial biopsy procedures. The double valve mechanism allows the clinician to manually create negative pressure by retracting the plunger, with a locking feature that maintains vacuum until controlled release is desired. The kit includes a transparent collection chamber for visualizing aspirated tissue, flexible or rigid polypropylene cannulas in various sizes (4-12mm), and all necessary components for the procedure. Unlike electric suction devices, the MVA requires no electricity or wall suction, making it ideal for office-based procedures, outpatient clinics, low-resource settings, and humanitarian field operations. For the obstetrician and gynecologist, the double valve MVA provides safe, effective uterine evacuation with lower complication rates than sharp curettage. For the patient, manual vacuum aspiration offers a gentler, less painful procedure with faster recovery, reduced bleeding, and lower risk of uterine perforation.

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Categories: OBSTETRICS, GYNECOLOGY AND NEONATAL, Gynecological Instruments, Single-Use Procedure Trays and Packs, SURGICAL INSTRUMENTS AND SUPPLIES Tags: Double Valve Aspirator, Double Valve MVA Kit, Endometrial Biopsy, Manual Aspirator, Manual Vacuum Aspiration, Miscarriage Management, MVA Kit, Post-Aspiration Kit, Pregnancy Termination Kit, Uterine Aspirator

Description

Double Valve MVA Kit

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Manual Uterine Aspiration for Pregnancy Termination

Primary Use: Provides a hand-held, manual vacuum aspiration system for early uterine evacuation in cases of incomplete miscarriage, missed abortion, or elective termination of pregnancy up to 10-12 weeks gestation.
How it helps: For the obstetrician and gynecologist, the double valve MVA kit enables safe, effective uterine aspiration without the need for electricity or wall suction—making it ideal for office-based procedures, outpatient clinics, and low-resource settings. For the patient, manual vacuum aspiration offers a gentler, less painful alternative to sharp curettage, with faster recovery and lower risk of complications such as uterine perforation.

2. Management of Incomplete Miscarriage

Primary Use: Used to evacuate retained products of conception from the uterus following incomplete spontaneous miscarriage, preventing complications such as infection, hemorrhage, and prolonged bleeding.
How it helps: For the clinician managing a patient with incomplete miscarriage, the double valve MVA provides a safe, effective method for completing the miscarriage without the need for operating room facilities—enabling timely intervention that reduces patient suffering and complication risk. For the patient, timely MVA resolves symptoms of bleeding and cramping, reduces the risk of infection, and allows for faster physical and emotional recovery.

3. Treatment of Gestational Trophoblastic Disease

Primary Use: Used for uterine evacuation in patients diagnosed with hydatidiform mole and other forms of gestational trophoblastic disease.
How it helps: For the gynecologic oncologist, the double valve MVA provides controlled, gentle suction for removing molar tissue while minimizing the risk of perforation and excessive bleeding. For the patient, proper evacuation of molar pregnancy is essential for initiating appropriate follow-up and monitoring for persistent trophoblastic disease.

4. Endometrial Biopsy and Diagnostic Sampling

Primary Use: Used to obtain endometrial tissue samples for histologic evaluation in patients with abnormal uterine bleeding, postmenopausal bleeding, or suspected endometrial pathology.
How it helps: For the clinician performing diagnostic sampling, the double valve MVA provides controlled suction for obtaining adequate endometrial tissue samples—improving diagnostic yield compared to blind biopsy techniques. For the patient, the MVA allows office-based sampling that is often better tolerated than traditional dilation and curettage, avoiding the need for operating room procedures.

SECONDARY & SUPPORTIVE USES

1. Retained Products of Conception Following Delivery: Used to evacuate retained placental fragments following vaginal delivery or cesarean section.

2. Subchorionic Hematoma Evacuation: Used to drain subchorionic hematomas in selected cases when clinically indicated.

3. Uterine Cavity Assessment: Used to aspirate uterine contents for diagnostic evaluation in cases of suspected intrauterine pathology.

4. Post-Aspiration Confirmation: Double valve design allows for confirmation of uterine emptiness by observing air bubbles in the collection chamber.

5. Low-Resource and Field Settings: Ideal for use in low-resource settings, family planning clinics, and humanitarian settings where electricity or wall suction is unavailable.

6. Training and Simulation: Used in medical education to train clinicians in uterine aspiration techniques.

7. Research and Clinical Studies: Used in research protocols requiring standardized endometrial sampling.

8. Postpartum Hemorrhage Management: Used as part of uterine evacuation protocols for retained tissue contributing to postpartum hemorrhage.

KEY PRODUCT FEATURES

1. BASIC IDENTIFICATION ATTRIBUTES

Device Type: A hand-held, manual vacuum aspiration system using a double valve mechanism to create negative pressure for uterine evacuation and endometrial sampling.
Designation: Double Valve MVA Kit, Manual Vacuum Aspiration Kit, MVA Kit, Double Valve Aspirator, Manual Uterine Aspirator, Post-Aspiration Kit.
Key Components:

o Aspirator Handle: Hand-held, double valve suction device with locking mechanism.

o Collection Chamber: Transparent chamber for collecting aspirated tissue.

o Cannulas: Flexible or rigid polypropylene cannulas in various sizes (4-12 mm).

o Double Valve Mechanism: Allows creation of vacuum and controlled release.

o Syringe Adapter: For connection to cannula.

o Specimen Container: For tissue transport to pathology laboratory.

o Instructions: Illustrated instructions for use.

2. TECHNICAL & PERFORMANCE PROPERTIES

Mechanism: Double valve design creates negative pressure via manual retraction of plunger.
Vacuum Strength: 50-60 mmHg vacuum pressure sufficient for early pregnancy and tissue aspiration.
Cannula Sizes: Available in sizes from 4mm to 12mm outer diameter.
Cannula Type: Flexible (polypropylene) or rigid (stainless steel) options.
Collection Volume: 60-120 mL collection chamber capacity.
Material: Medical-grade plastics; latex-free.
Sterility: Sterile components; single-use or reusable depending on model.
Reusability: Single-use disposable kits or reusable aspirator with disposable cannulas.

3. PHYSICAL & OPERATIONAL PROPERTIES

Construction: Lightweight, hand-held design for single-handed operation.
Collection Chamber: Clear graduated chamber for visualizing aspirated tissue.
Valve Mechanism: Double valve allowing vacuum creation and controlled tissue release.
Cannula Markings: Depth markings on cannulas for controlled insertion.
Portability: No electricity or external suction required; fully portable.
Packaging: Sterile, sealed kit containing all components.

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory Status: Class II medical device requiring 510(k) clearance.
FDA Compliance: Compliant with FDA Quality System Regulations.
Sterility: Sterile; sterility assurance level (SAL) of 10^-6.
Latex-Free: Manufactured without natural rubber latex.
Biocompatibility: Materials tested for intrauterine contact safety.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Store in a clean, dry location at room temperature; protect from heat, moisture, and direct sunlight.
Shelf Life: Typically 2-3 years from date of manufacture; check expiration date before use.
Sterility Maintenance: Do not use if package is opened, torn, wet, or damaged.
Single-Use: For single-use kits, discard all components after procedure as biohazardous waste.

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Manual uterine aspiration for early pregnancy termination, incomplete miscarriage management, endometrial biopsy, and gestational trophoblastic disease evacuation.
Clinical Role: Essential device in obstetrics and gynecology, family planning clinics, reproductive health centers, emergency departments, and low-resource settings for uterine evacuation and endometrial sampling procedures.

SAFETY HANDLING PRECAUTIONS

1. SAFETY PRECAUTIONS

Pre-Procedure Assessment: Confirm pregnancy location (intrauterine) before procedure; rule out ectopic pregnancy.
Cervical Preparation: Consider cervical preparation (misoprostol) for nulliparous or cervical stenosis patients.
Cannula Selection: Select appropriate cannula size for gestational age and clinical indication.
Ultrasound Guidance: Use ultrasound guidance when available for confirmation of complete evacuation.
Vacuum Confirmation: Confirm vacuum creation before insertion; double valve should lock in retracted position.
Gentle Insertion: Insert cannula gently through cervical os without force to prevent perforation.
Controlled Rotation: Rotate cannula gently during aspiration; avoid aggressive curettage.
Tissue Confirmation: Inspect aspirated tissue to confirm adequacy of sample or completeness of evacuation.
Rh Status: Check Rh status; administer Rh immunoglobulin if indicated.
Infection Prophylaxis: Consider prophylactic antibiotics per clinical protocol.

2. FIRST AID MEASURES

Uterine Perforation: If perforation is suspected, stop procedure immediately; monitor vital signs; assess for intra-abdominal bleeding; consult surgical team.
Excessive Bleeding: If bleeding exceeds expected (more than 500 mL), stop procedure; administer uterotonics; consider referral for higher level of care.
Incomplete Evacuation: If tissue remains after aspiration, consider repeat aspiration or referral for surgical management.
Vasovagal Response: If patient experiences bradycardia or hypotension, stop procedure; position patient supine; monitor vital signs.

3.FIRE FIGHTING MEASURES

Flammability: Plastic components are combustible; may melt or burn if exposed to flame or high heat.
Extinguishing Media: Use water, foam, dry chemical, or CO₂ for fire involving plastic materials.
Fire Response: No special fire hazards beyond typical combustible materials.

Double Valve MVA Kit

Double Valve MVA Kit

PRIMARY CLINICAL & DIAGNOSTIC USES

1. Manual Uterine Aspiration for Pregnancy Termination

Primary Use: Provides a hand-held, manual vacuum aspiration system for early uterine evacuation in cases of incomplete miscarriage, missed abortion, or elective termination of pregnancy up to 10-12 weeks gestation.

2. Management of Incomplete Miscarriage

Primary Use: Used to evacuate retained products of conception from the uterus following incomplete spontaneous miscarriage, preventing complications such as infection, hemorrhage, and prolonged bleeding.

3. Treatment of Gestational Trophoblastic Disease

Primary Use: Used for uterine evacuation in patients diagnosed with hydatidiform mole and other forms of gestational trophoblastic disease.

4. Endometrial Biopsy and Diagnostic Sampling

Primary Use: Used to obtain endometrial tissue samples for histologic evaluation in patients with abnormal uterine bleeding, postmenopausal bleeding, or suspected endometrial pathology.

SECONDARY & SUPPORTIVE USES

1. Retained Products of Conception Following Delivery: Used to evacuate retained placental fragments following vaginal delivery or cesarean section.

2. Subchorionic Hematoma Evacuation: Used to drain subchorionic hematomas in selected cases when clinically indicated.

3. Uterine Cavity Assessment: Used to aspirate uterine contents for diagnostic evaluation in cases of suspected intrauterine pathology.

4. Post-Aspiration Confirmation: Double valve design allows for confirmation of uterine emptiness by observing air bubbles in the collection chamber.

5. Low-Resource and Field Settings: Ideal for use in low-resource settings, family planning clinics, and humanitarian settings where electricity or wall suction is unavailable.

6. Training and Simulation: Used in medical education to train clinicians in uterine aspiration techniques.

7. Research and Clinical Studies: Used in research protocols requiring standardized endometrial sampling.

8. Postpartum Hemorrhage Management: Used as part of uterine evacuation protocols for retained tissue contributing to postpartum hemorrhage.

1. BASIC IDENTIFICATION ATTRIBUTES

Device Type: A hand-held, manual vacuum aspiration system using a double valve mechanism to create negative pressure for uterine evacuation and endometrial sampling.

Designation: Double Valve MVA Kit, Manual Vacuum Aspiration Kit, MVA Kit, Double Valve Aspirator, Manual Uterine Aspirator, Post-Aspiration Kit.

Key Components:

o Aspirator Handle: Hand-held, double valve suction device with locking mechanism.

o Collection Chamber: Transparent chamber for collecting aspirated tissue.

o Cannulas: Flexible or rigid polypropylene cannulas in various sizes (4-12 mm).

o Double Valve Mechanism: Allows creation of vacuum and controlled release.

o Syringe Adapter: For connection to cannula.

o Specimen Container: For tissue transport to pathology laboratory.

o Instructions: Illustrated instructions for use.

2. TECHNICAL & PERFORMANCE PROPERTIES

Mechanism: Double valve design creates negative pressure via manual retraction of plunger.

Vacuum Strength: 50-60 mmHg vacuum pressure sufficient for early pregnancy and tissue aspiration.

Cannula Sizes: Available in sizes from 4mm to 12mm outer diameter.

Cannula Type: Flexible (polypropylene) or rigid (stainless steel) options.

Collection Volume: 60-120 mL collection chamber capacity.

Material: Medical-grade plastics; latex-free.

Sterility: Sterile components; single-use or reusable depending on model.

Reusability: Single-use disposable kits or reusable aspirator with disposable cannulas.

3. PHYSICAL & OPERATIONAL PROPERTIES

Construction: Lightweight, hand-held design for single-handed operation.

Collection Chamber: Clear graduated chamber for visualizing aspirated tissue.

Valve Mechanism: Double valve allowing vacuum creation and controlled tissue release.

Cannula Markings: Depth markings on cannulas for controlled insertion.

Portability: No electricity or external suction required; fully portable.

Packaging: Sterile, sealed kit containing all components.

4. SAFETY & COMPLIANCE ATTRIBUTES

Regulatory Status: Class II medical device requiring 510(k) clearance.

FDA Compliance: Compliant with FDA Quality System Regulations.

Sterility: Sterile; sterility assurance level (SAL) of 10^-6.

Latex-Free: Manufactured without natural rubber latex.

Biocompatibility: Materials tested for intrauterine contact safety.

5. STORAGE & HANDLING ATTRIBUTES

Storage: Store in a clean, dry location at room temperature; protect from heat, moisture, and direct sunlight.

Shelf Life: Typically 2-3 years from date of manufacture; check expiration date before use.

Sterility Maintenance: Do not use if package is opened, torn, wet, or damaged.

Single-Use: For single-use kits, discard all components after procedure as biohazardous waste.

6. LABORATORY & CLINICAL APPLICATIONS

Primary Application: Manual uterine aspiration for early pregnancy termination, incomplete miscarriage management, endometrial biopsy, and gestational trophoblastic disease evacuation.

Clinical Role: Essential device in obstetrics and gynecology, family planning clinics, reproductive health centers, emergency departments, and low-resource settings for uterine evacuation and endometrial sampling procedures.

1. SAFETY PRECAUTIONS

Pre-Procedure Assessment: Confirm pregnancy location (intrauterine) before procedure; rule out ectopic pregnancy.

Cervical Preparation: Consider cervical preparation (misoprostol) for nulliparous or cervical stenosis patients.

Cannula Selection: Select appropriate cannula size for gestational age and clinical indication.

Ultrasound Guidance: Use ultrasound guidance when available for confirmation of complete evacuation.

Vacuum Confirmation: Confirm vacuum creation before insertion; double valve should lock in retracted position.

Gentle Insertion: Insert cannula gently through cervical os without force to prevent perforation.

Controlled Rotation: Rotate cannula gently during aspiration; avoid aggressive curettage.

Tissue Confirmation: Inspect aspirated tissue to confirm adequacy of sample or completeness of evacuation.

Rh Status: Check Rh status; administer Rh immunoglobulin if indicated.

Infection Prophylaxis: Consider prophylactic antibiotics per clinical protocol.

2. FIRST AID MEASURES

Uterine Perforation: If perforation is suspected, stop procedure immediately; monitor vital signs; assess for intra-abdominal bleeding; consult surgical team.

Excessive Bleeding: If bleeding exceeds expected (more than 500 mL), stop procedure; administer uterotonics; consider referral for higher level of care.

Incomplete Evacuation: If tissue remains after aspiration, consider repeat aspiration or referral for surgical management.

Vasovagal Response: If patient experiences bradycardia or hypotension, stop procedure; position patient supine; monitor vital signs.

3.FIRE FIGHTING MEASURES

Flammability: Plastic components are combustible; may melt or burn if exposed to flame or high heat.

Extinguishing Media: Use water, foam, dry chemical, or CO₂ for fire involving plastic materials.