Version 1.0 | Rev. A | 2025 - 03 - 28 REBLOOM GRS VAGINAL TRAINERS Instructions for Use Version 1.0 | Rev. A | 2025 - 03 - 28 Please read this instruction manual carefully before using Rebloom GRS Vaginal Trainers. For any questions regarding this product, please contact a physician or healthcare professional, or consult the REBLOOM team. Product Name: Rebloom GRS Vaginal Trainers Product Description • The Rebloom GRS Vaginal Trainer is intended for post - gender reassignment surgery (GRS) to aid in postoperative vaginal dilation therapy. Utilizing balloon dilation technology, it effectively reduces the pain and discomfort associated with conventional rigi d dilators. • Material: Polyurethane • The product consists of three main components: a balloon catheter, extension tubing, and a two - way stopcock. The balloon catheter consists of a tip, connecting tube, balloon, catheter, and catheter hub. It is suitable for patients requiring gradual vaginal tissue expansion. Illustration of the Vaginal Dilator Version 1.0 | Rev. A | 2025 - 03 - 28 Recommended Syringe (Not Included): To ensure proper use of this product, it is recommended to use a syringe with the following specifications: ● Type: Luer - lock connection with a threaded male tip, compatible with the product’s female two - way valve ● Capacity: 100 mL (also labeled as 100 cc) ● Graduation: Markings in 2 mL or 1 mL increments Syringes with these specifications are widely available through medical supply distributors and major online platforms. Example product descriptions for reference: “100 mL Luer - lock syringe (no needle)” or “100 cc syringe with Luer - lock tip” Please ensure the syringe is clean and sterile before each use. Version 1.0 | Rev. A | 2025 - 03 - 28 Model, Specifications, and Main Components • Balloon Volume: Refer to Tables 1 and 2 for maximum volume Table 1: Size Specification Table Specifications Effective Balloon Length (mm) Total Catheter Length (mm) Maximum Inflation Volume (mL) RGVT - 38050 50 250 48 RGVT - 38100 100 250 100 RGVT - 38150 150 250 144 Table 2: Inflation Diameter - Volume Table Model Specification Inflation Volume (mL) Balloon Diameter (mm) Effective Balloon Length (mm) RGVT - 38050 30▲ 32 N/A 34 34 N/A 40 36 N/A 48■ 38 50 RGVT - 38100 68▲ 32 N/A 76 34 N/A 86 36 N/A 100■ 38 100 RGVT - 38150 100▲ 32 N/A 116 34 N/A 128 36 N/A 144■ 38 150 • Note: ▲ represents nominal inflation volume, ■ represents maximum inflation volume. Do not exceed the maximum inflation volume of the balloon. Version 1.0 | Rev. A | 2025 - 03 - 28 Intended Use • Maintaining or expanding the newly constructed vaginal cavity post - surgery. Target Population • Patients post - gender reassignment surgery (GRS) with fully healed tissues and no open wounds. Contraindications • Not suitable for patients with severe infections, urethral or rectal injuries, vaginal - rectal fistulas, or vaginal - urethral fistulas where tissue healing is incomplete. • Not to be used on patients with known allergies to polyurethane material. Potential Adverse Effects and Complications • Abnormal vaginal discharge accompanied by odor or infection - related symptoms. • Balloon catheter rupture, potentially causing local mucosal injury, bleeding, or increased infection risk. • Balloon catheter becoming stuck after use, requiring medical intervention. • Allergic reactions such as redness, rashes, burning sensation or itching due to sensitivity to polyurethane materials. • Inadequate or incomplete disinfection before use may increase infection risk. Version 1.0 | Rev. A | 2025 - 03 - 28 Warnings and Precautions • This product is for single - user only. Sharing with others is strictly prohibited to avoid cross - contamination or potential risks • If you experience severe pain or discomfort during use, stop using this product immediately and consult a physician. • After use, clean and disinfect thoroughly to prevent cross - infection • Do not excessively bend the catheter to prevent blockage or interference with normal use. • If the balloon is found to be ruptured, stop using the product and replace it with a new product. • Frequency of Use: As instructed by the physician. • Handling Instructions: - Select an appropriate working environment based on the product's temperature and pressure tolerance range to avoid exceeding its endurance limits (e.g., high - temperature and high - pressure environments). - Ensure that the method of use complies with product regulations and relevant medical standards to maintain product safety and functionality. • Do not exceed the maximum inflation volume of the balloon (See Table 1). • This product is non - sterile. - The product is reusable. - Under normal operation and proper storage, the product's total expansion duration can reach 90 hours, with up to 300 uses. The recommended usage period is three months. - Do not continue to use it if the product is ruptured, pinched, or torn. Version 1.0 | Rev. A | 2025 - 03 - 28 Operation Procedures 1. Product Inspection & Preparation o Ensure product packaging is intact and within its expiration date. o Before use, disinfect the product surface with 75% alcohol to ensure it is free of contamination. 2. Equipment & Environment Preparation o Clean the patient's genital area to ensure a hygienic operating area. o Connecting Components: Attach the extension catheter and two - way valve sequentially to the device, ensuring a secure connection. o Air Expulsion: Open the two - way valve, fill the balloon with normal saline to expel the air, then close the two - way valve. 3. Insertion & Fixation o Lubrication: Apply an appropriate amount of lubricant evenly to the device surface to reduce discomfort during insertion. o Insertion: Gently insert the device into the vaginal cavity, adjusting the depth as needed to ensure proper placement. Version 1.0 | Rev. A | 2025 - 03 - 28 4. Inflation & Expansion o Injection: Open the two - way valve and inject normal saline. ▪ Note: Refer to Tables 1 and 2 for corresponding volume. o Gradual Inflation: Slowly increase the amount of normal saline until the balloon reaches the inflation volume as directed by the physician. Then, close the two - way valve to stop normal saline injection. o Static Expansion: Leave the device in place according to the instructions of the attending physician or therapist. 5. Removal & Cleaning o Deflation: Open the two - way valve and use a syringe to withdraw the normal saline from the device, ensuring the balloon is completely emptied. o Remove the two - way valve, extension tube, balloon catheter and syringe. o After use, immediately clean and disinfect the exterior surface and inner lumen of the balloon catheter with 75% alcohol. Allow it to dry and store it in a cool, well - ventilated place. o Before reuse, clean and disinfect the exterior surface and inner lumen of the balloon catheter with 75% alcohol. Ensure the exterior surface is completely dry before use o Store the product at room temperature in a dry, well - ventilated area. Avoid compression, moisture, bending, or direct sunlight exposure. Version 1.0 | Rev. A | 2025 - 03 - 28 Expiration date: Refer to the label on the outer packaging. Version 1.0 | Rev. A | 2025 - 03 - 28 Explanation of symbols Catalogue number Use by date Date of manufacture Serial number Batch code Consult instructions for use Do not use if package is damaged Keep away from sunlight Keep dry Non - sterile Unique device identifier Medical device Version 1.0 | Rev. A | 2025 - 03 - 28 Manufactured for Gshen Medical Co., Ltd. 3F., No. 277, Sec. 4, Bade Rd., Songshan Dist., Taipei City 105056, Taiwan TEL: +886 - 2 - 27667699 FAX: +886 - 2 - 27423722 EMAIL: customerservice@gshenmedical.com Manufactured by Lifetech Scientific (Shenzhen) Co., Ltd. 8F, LifeTech Scientific Building, No.22, Keji 12th Road South, High - Tech Industrial Park, Yuehai Subdistrict, Nanshan District, Shenzhen 518063, P.R. China