Milex TM Pessary Fitting Kit (English) Kit de pose de pessaire Milex TM (Français / French) Fitting Instructions for the Health Care Professional

Milex TM Pessary Fitting Kit (English) Kit de pose de pessaire Milex TM (Français / French) Fitting Instructions for the Health Care Professional Silicone (Latex Free) Pessary Fitting Kit TM 95 Corporate Drive Trumbull, CT 06611 USA Phone: (800) 243-2974 Fax: (800) 262-0105 www.coopersurgical.com 0086 FITTING PESSARIES ARE NOT TO BE WORN MORE THAN 15 MINUTES! CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician. Latex Free Made in the USA International Phone: (203) 601-9818 Fax: (203) 601-4747 EC REP EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA MXFITCA-DFU Rev. A 6/13

Milex TM Pessary Fitting Kit (English) Fitting Instructions for the Health Care Professional Silicone (Latex Free) Pessary Fitting Kit TM 95 Corporate Drive Trumbull, CT 06611 USA Phone: (800) 243-2974 Fax: (800) 262-0105 www.coopersurgical.com 0086 FITTING PESSARIES ARE NOT TO BE WORN MORE THAN 15 MINUTES! CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician. Latex Free Made in the USA International Phone: (203) 601-9818 Fax: (203) 601-4747 EC REP EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands CooperSurgical, Inc. 95 Corporate Drive Trumbull, CT 06611 USA MXFITCA-DFU Rev. A 6/13 1

GENERAL INFORMATION PURPOSE The Milex Pessary Fitting Kit was developed to help you as a health care professional determine accurate pessary type and size prior to prescribing a pessary for your patient. CONTENTS The pessaries included in this kit are: Incontinence Dish with Support, Ring with Support, Donut, Gellhorn and Cube. The shaded area indicates sizes recommended for pessary inventory, as they are the most common sizes. With these sizes you will be able to fit approximately 85% of patients. Also included in this kit are a foam model and carrying case. Warning: Fitting pessaries are not to be worn more than 15 minutes! LATEx-FREE CURRENT SILICONE INFORMATION: CooperSurgical has had nontoxic silicone gynecologic devices available for hyper-allergic patients for more than 10 years. AdvANTAGES OF SILICONE: 1. Longer shelf life and use life 2. Can be autoclaved PESSARy CARE: Pessaries are powdered with food-grade powder. The powder must be washed off with a mild soap and the pessary thor ough ly rinsed with water and dried prior to initial use. Prior to insertion of any pessary, it is important to thoroughly clean and remove any matter that may be on the outer surface. CooperSurgical recommends washing with mild soap and thoroughly rinsing with water prior to initial use. The yellow Milex fitting pessaries are designed to be used in the physician s office for selecting and fitting the correct pessary for individual patient use and should only be worn in 15-minute increments, as many of the fitting pessaries do not have nylon pegs for support. The yellow fitting pessaries should be cleaned and sterilized prior to fitting each patient but do not need to be stored in a sterile environment. With the realization that many different techniques are practiced in the health care community, we attempted to optimize methods to afford the best coverage for our customers. Every facility should validate its own equipment and parameters before processing any medical device. RECOMMENdEd CLEANING BEFORE INSERTION Decontamination/Disinfection: CIDEX OPA for 12 minutes The agent must be thoroughly rinsed off with water. RECOMMENdEd STERILIZATION BEFORE INSERTION Pre-vacuum: 270 F - 275 F (132 C - 135 C) for 4 minutes Gravity displacement: 250 F - 255 F (121 C - 124 C) for 40 minutes FITTING IN STRUC TIONS FOR THE HEALTH CARE PROFESSIONAL IMPORTANT Pessaries are fitted by trial and error. There are no mechanical devices available that can accurately determine the size or type of pessary your patient requires to obtain the desired results. Fitting diaphragms should not be used to measure the size pessary a patient will need. Diaphragms fit differently from pessaries. Even before fitting a pessary, the patient should be informed that it is not uncommon to have to change the size or type of pessary more than once after being originally fitted. This is why it is so important that your patient be instructed to return with in 24 hours of the initial fitting and again in 72 hours. Thereafter, re-examination every few months is recommended to ensure that a proper fit is maintained as long as the patient is wearing the pessary. At each visit the pessary should be removed and the vaginal vault inspected for signs of allergic reaction or undue pressure. At the physician s discretion, the patient can be instructed in the proper removal, cleaning and reinsertion techniques for her own pessary. This process can be performed nightly by the patient under ideal circumstances. The INFLATOBALL, CUBE and TANDEM-CUBE pessaries are the three exceptions to the above. Patients must be instructed to insert, remove and clean these pessaries daily. The CUBE and TANDEM-CUBE pessaries fill the entire vaginal vault and have no area for drainage. The INFLATOBALL pessary should not be left in place more than 24 consecutive hours. A noncompliant patient should not be fitted with any pessary. It is essential that your patient understands the importance of these frequent follow-up visits and that she fully cooperates with you to ensure the desired results Note: Each type of pessary is available in a wide range of sizes most pessaries are made in 7 to 14 different sizes. Experience has shown that in order to properly fit a pessary, you should have at least one of the most commonly used sizes of the pessary (see the size charts). Note: When you purchase the pessaries for your patients, detailed fitting instructions are included in the box for your use along with pessary instructions for the patients. HAvE PATIENT REPORT ANy OF THESE SyMPTOMS: Any changes in the color or consistency of vaginal discharge Any increase in amount of vaginal discharge Any foul odor associated with vaginal discharge Vaginal itching Complete Prolapse. Pessaries recommended for third-degree prolapse/procidentia are: Inflated Silicone Donut, 95% Rigid Silicone Gellhorn, Flexible Silicone Gellhorn (Folding), Inflatoball, Silicone Cube or Silicone Tandem-Cube. Incontinence. Pessaries recommended for incontinence are: Ring with knob, Incontinence Ring, Ring with Support and Knob, Hodge with Support and knob, Hodge with knob, Hodge with Support, Hodge, Incontinence Dish, Risser, Incontinence Dish with Support, Smith and Gehrung with Knob. For medical emergencies and for all other medically-related advice, consult your health care professional. Review separate instructions with patient to establish use regimen. 2

Incontinence dish with Support Fitting Pessary 65 mm, 70 mm, 75 mm, 80 mm (Sizes 2, 3, 4, 5) For stress urinary incontinence with mild prolapse and mild cystocele INdICATIONS: Stress urinary incontinence The INCONTINENCE DISH WITH SUPPORT is indicated for stress urinary incontinence with a mild uterine prolapse and mild cystocele. CONTRAINdICATIONS: The presence of pelvic infections and/or lacerations A noncompliant patient Endometriosis has been suggested as a possible contraindication to pessary use Health care professionals should use their own professional judgment as to the advisability of using this pessary in a pregnant patient description: The INCONTINENCE DISH WITH SUPPORT silicone flexible fitting pessary is designed for stress urinary incontinence with mild prolapse and mild cystocele. Using this pessary allows a non-surgical approach to stress urinary incontinence. To properly fit a patient with an INCONTINENCE DISH WITH SUPPORT pessary, it is necessary to have available a minimum of four sizes. The shaded area indicates sizes recommended for office fitting (most common sizes). With these sizes you will be able to fit approximately 85% of patients. Available in the Following Sizes Remember for sizing: The incontinence knob available for these pessaries adds 1/2 inch (13 mm) to the diameter. Diameter 55 60 65 70 75 80 85 Note: We recommend the INCONTINENCE DISH WITH SUPPORT pessary be inserted and removed by a physician or other health care professional. Other styles/models of pessaries (all single-patient use only) are available. Consult the CooperSurgical website at www.coopersurgical.com for details. PRIOR TO FITTING: An incontinence pessary is best fitted before patient empties her bladder. Ulcerations and erosions frequently occur in cases of complete prolapse due to irritation of the exteriorized cervix. Whenever possible, reducing the mass and treating the irritation are primary steps before using a pessary. The only method of determining the proper size INCONTINENCE DISH WITH SUPPORT pessary is trial and error. The unique flexible silicone design facilitates insertion and removal. Silicone does not absorb secretions or emit odors. INSTRUCTIONS FOR USE STEP-By-STEP FITTING INSTRUCTIONS FOR THIS PESSARy It is essential that all incontinence pessaries be precisely fitted. Physicians find it advisable to have available the most commonly used sizes of this pessary. In general, the largest pessary that a patient can comfortably accommodate should be fitted. Perform a normal pelvic examination before inserting or fitting of any pessary. A first approximation of size can be made by using your fingers to determine the approximate width and length (from the posterior fornix to under the symphysis pubis) of the vaginal vault. This will generally get you within a size or two of the proper pessary. Note: If necessary, irrigate the vagina prior to insertion of the pessary. This will cleanse the vagina of excess discharge and secretions. HCPCS Supply Number A4320 (Irrigation Tray with Syringe, any purpose). CPT CODE Procedure: 57160 HCPCS: A4562 Available models not included in fitting kit: Incontinence dish For stress urinary incontinence with mild prolapse Incontinence Ring For stress urinary incontinence 3

1. Wear dry gloves. When necessary, lubricate the entering end of the pessary. Hold the pessary as shown in Figure 1. Compress the pessary (bringing sides together) as shown in Figure 1. 2. Use one finger of the opposite hand to depress the perineum. Hold the pessary almost parallel with the introitus (see Figure 2). Direct the entering end of the pessary past the cervix into the posterior fornix. Allow the pessary to open into shape after passing the introitus. 3. Use the index finger to guide the pessary along the lower vaginal wall, behind the cervix, and into the posterior fornix. 4. Use the index finger to bring the knob up behind the symphysis pubis (see Figure 3). Figure 1 Figure 2 5. Have the patient sit, stand and bear down slightly. If there is no leakage of urine and the patient is comfortable with the pessary in position, have her empty her bladder. Figure 3 If she is unable to urinate with the pessary in position, remove the pessary and fit her with a smaller size and repeat Step 5. If the patient is able to void, continue with Step 6. 6. If she can do so without difficulty and the pessary remains in position upon re-examination, and the patient is comfortable with the pessary in place, you have a good indication you have selected the correct size. 7. Examine the patient while she is in the standing position to ensure the pessary has not shifted position. The patient should not feel the pessary once it is in position. The pessary should not be too loose as it may turn or be expelled and it should not be too tight as it may cause discomfort. 8. The health care professional should be able to sweep one finger between the pessary and vaginal walls. If there is not enough space to do this, the next smaller pessary should be tried. If excessive space exists, the pessary will not be effective and may rotate or even be expelled. 9. It is sometimes necessary to refit the patient with a different size or type of pessary after a period of time. Do not assume that a replacement will always be the same size as the previous one. Check the fitting to ensure continued patient comfort and relief of symptoms. The use life of a pessary is limited. Examine frequently for signs of deterioration. Note: It is essential that all incontinence pessaries be precisely fitted. Physicians should have available the four most commonly used sizes of this pessary (see the size chart). In a limited number of cases, a larger size INCONTINENCE DISH pessary (required to stabilize bladder base) may be difficult to pass through the introitus. In such instances the Milex FOLDING HODGE pessary with knob is an excellent alternative. PATIENT FOLLOW-UP: Have the patient: Report immediately any difficulty in urinating Report immediately any discomfort Return within 24 hours for first examination Return for second examination within 3 days Return for examination every 4 to 6 weeks Note: Above schedule of follow-up examinations may be altered to fit the needs of the individual patient. At each check up, the pessary should be removed and cleaned. If no contraindications are present, the pessary is reinserted. TO REMOvE: Use the index finger to depress the perineum. Hook other index finger under the knob of the INCONTINENCE DISH pessary and pull down. Fold the pessary by bringing the sides together, angling it so that it is almost parallel to the introitus, and gently ease the pessary out. Note: If necessary, irrigate the vagina after removal of the pessary (and before reinsertion) to cleanse the vagina of excess discharge and secretions. HCPCS Supply Number A4320 (Irrigation Tray with Syringe, any purpose). During each visit, the vagina should be carefully inspected for evidence of pressure or allergic reaction. The patient should be questioned concerning discharge, and disturbance of bowel function or urination. It may be necessary to fit another size or an entirely different type of pessary if these conditions are present. do NOT assume that a replacement will be the same size as the previous one. Check the fitting to ensure patient comfort and relief of symptoms. At each checkup, the pessary is removed and cleaned. If there are no contraindications, the pessary is reinserted. 4

Ring with Support Fitting Pessary 2-1/4, 2-1/2, 2-3/4, 3, 3-1/4, 3-1/2 (Sizes 2, 3, 4, 5, 6, 7) For mild uterine prolapse complicated by mild cystocele description: The Ring with Support silicone flexible pessary is designed for mild uterine prolapse complicated by a mild cystocele. Using this pessary allows a non-surgical approach to mild uterine prolapse. To properly fit a patient with a RING pessary, it is necessary to have available a minimum of four sizes to as many as six depending on the type. The shaded area indicates sizes recommended for office fit ting (most common sizes). With these sizes you will be able to fit approximately 85% of patients. WARNING: Sizes 11 through 13 contain a wire coil remove before X-ray or MRI. Available in the Following SIzes Size Dimensions Dimensions # (in inches) (in mm) 00 1-3/4 44 01 2 51 02 2-1/4 57 03 2-1/2 64 04 2-3/4 70 05 3 76 06 3-1/4 83 Size Dimensions Dimensions # (in inches) (in mm) 07 3-1/2 89 08 3-3/4 95 09 4 102 10 4-1/4 108 11 4-1/2 114 12 4-3/4 121 13 5 127 Note: We recommend this pessary be inserted and removed by a physician or other health care professional. Other styles/models of pessaries (all single-patient use only) are available. Consult the CooperSurgical website at www.coopersurgical.com for details. INdICATIONS: The Milex RING with SUPPORT pessary is extremely effective in providing the necessary support in first- and second-degree prolapse complicated by a mild cystocele. CONTRAINdICATIONS: The presence of pelvic infections and/or lacerations A noncompliant patient Endometriosis has been suggested as a possible contraindication to pessary use Health care professionals should use their own professional judgment as to the advisability of using this pessary in a pregnant patient PRIOR TO FITTING: An incontinence pessary is best fitted before the patient empties her bladder. Ulcerations and erosions frequently occur in cases of complete prolapse due to irritation of the exteriorized cervix. Whenever possible, reducing the mass and treating the irritation are primary steps before using a pessary. The only method of determining the proper size RING pessary is trial and error. The holes or open center of the RING pessary allow for drainage without reducing the effectiveness of the pessary. The unique silicone folding design facilitates simple insertion and removal. Unlike latex rubber, silicone does not absorb secretions or emit odors. INSTRUCTIONS FOR USE STEP-By-STEP FITTING INSTRUCTIONS FOR THIS PESSARy It is essential that all pessaries be precisely fitted. Physicians find it advisable to have available the most commonly used sizes of this pessary. In general, the largest pessary that a patient can comfortably accommodate should be fitted. Perform a normal pelvic examination before inserting or fitting any pessary. A first approximation of size can be made by using your fingers to determine the approximate width and length of the vaginal vault (from posterior fornix to under symphysis pubis). This will generally get you within a size or two of the proper size pessary. Note: If necessary, irrigate the vagina prior to insertion of the pessary. This will cleanse the vagina of excess discharge and secretions. HCPCS Supply Number A4320 (Irrigation Tray with Syringe, any purpose). CPT CODE Procedure: 57160 HCPCS: A4562 Available models not included in fitting kit: RING Pessary without support Is extremely effective in providing the necessary support in first- and second-degree prolapse. RING Pessary with knob ANd without support Is indicated for stress urinary incontinence complicated by first- or second-degree uterine prolapse. RING Pessary with knob ANd with support Is indicated for stress urinary incontinence complicated by first- or second-degree uterine prolapse and mild cystocele. Remember for sizing: The incontinence knob available for this pessary adds 1/2 inch (13 mm) to the diameter. 5

1. Wear dry gloves. When necessary, lubricate the entering end of the pessary. Hold as illustrated in Figure 1. 2. The pessary is folded by bringing the small round holes together. The arch formed points downward as shown with the RING pessary (see Figure 2). Figure 1 Figure 2 3. Direct the pessary past the cervix into the posterior fornix. Allow the pessary to open again into the ring shape after passing the introitus. 4. The index finger is inserted deep into the vagina to turn the pessary approximately 90 (see Figure 3). The RING pessary in this position cannot be folded and pushed out. 5. Have the patient sit, stand and bear down slightly. If there is no leakage of urine and the patient is comfortable with the pessary in Figure 3 position, have her empty her bladder. A properly fitted pessary takes up slack in redundant tissue, holding the uterus high, in a sort of sling. Note: If she is unable to urinate with the pessary in position, remove the pessary and fit her with a smaller size and repeat Step 5. If the patient is able to void, continue with Step 6. 6. If she can void without difficulty and the pessary remains in position upon re-examination, and the patient is comfortable with the pessary in place, you have a good indication that you have selected the correct size. 7. Examine the patient while she is in the standing position to ensure the pessary has not shifted position. The patient should not feel the pessary once it is in position. The pessary should not be too loose as it may turn or be expelled, and it should not be too tight as it may cause discomfort. 8. The health care professional should be able to sweep one finger between the pessary and the vaginal walls. If there is not enough space to do this, the next smaller size should be tried. If excessive space exists, the pessary will not be effective and may rotate or even be expelled (see Figure 3). 9. It is sometimes necessary to refit the patient with a different size or type of pessary after a period of time. Do not assume that a replacement will always be the same size as the previous one. Check the fitting to ensure continued patient comfort and relief of symptoms. The use life of a pessary is limited. Examine frequently for signs of deterioration. PATIENT FOLLOW-UP: Have the patient: Report immediately any difficulty in urinating Report immediately any dis com fort Return within 24 hours for first examination Return for second examination within 3 days Return for examination every 4 to 6 weeks Note: Above schedule of follow-up examinations may be al tered to fit the needs of the individual patient. At each checkup, the pessary should be removed and cleaned. If no contraindications are present, the pessary is reinserted. TO REMOvE: Use one finger to depress the perineum. Turn the pessary until the notches face the introitus. Fold the pessary and gently ease it out. Note: If necessary, irrigate the vagina after removal of the pessary (and before reinsertion) to cleanse the vagina of excess discharge and secretions. HCPCS Supply Number A4320 (Irrigation Tray with Syringe, any purpose). During each visit, the vagina should be carefully inspected for evidence of pressure or allergic reaction. The patient should be questioned concerning douching, discharge, disturbance of bowel function or urination. It may be necessary to fit another size or an entirely different type of pessary. do NOT assume that a replacement will be the same size as the previous one. Check the fitting to ensure patient comfort and relief of symptoms. At each checkup, the pessary is removed and cleaned. If there are no contraindications, the pessary is reinserted. 6

donut Fitting Pessary 2-1/2, 2-3/4, 3, 3-1/4 (Sizes 2, 3, 4, 5) For third-degree uterine prolapse/procidentia description: The DONUT fitting pessary is designed for third-degree prolapse/prodentia. Using this pessary allows a non-surgical approach to uterine prolapse. To properly fit a patient with a DONUT pessary it is necessary to have available a minimum of four sizes. The shaded area indicates sizes recommended for office fit ting (most common sizes). With these sizes you will be able to fit approximately 85% of patients. Note: We recommend the DONUT pessary be inserted and removed by a physician or other health care professional. Available in the following sizes Diameter in inches Diameter in mm 2 51 2-1/4 57 2-1/2 64 2-3/4 70 3 76 3-1/4 83 3-1/2 89 3-3/4 95 Other styles/models of pessaries (all single-patient use only) are available. Consult the CooperSurgical website at www.coopersurgical.com for details. INdICATIONS: For effective support of third-degree prolapse or procidentia. CONTRAINdICATIONS: The presence of pelvic infections and/or lacerations Since the DONUT pessary may be difficult for the patient to remove, it is also contraindicated in any sexually active patient A noncompliant patient Endometriosis has been suggested as a possible contraindication to pessary use Health care professionals should use their own professional judgment as to the advisability of using this pessary in a pregnant patient PRIOR TO FITTING: Have the patient empty her bladder before fitting this pessary. Ulcerations and erosions frequently occur in cases of complete prolapse due to irritation of the exteriorized cervix. Whenever possible, reducing the mass and treating the irritation are primary steps before using a pessary. The only method of determining the proper size DONUT pessary is trial and error. The inside diameter allows for drainage without reducing the effectiveness of the pessary. The unique flexible silicone design facilitates insertion and removal. Silicone does not absorb secretions or emit odors. INSTRUCTIONS FOR USE STEP-By-STEP FITTING INSTRUCTIONS FOR THIS PESSARy In general, the largest pessary that a patient can comfortably accommodate should be fitted. Perform a normal pelvic examination before inserting or fitting of any pessary. A first approximation of size can be made by using your fingers to determine the approximate width of the vaginal vault. This will generally get you within a size or two of the proper pessary. Note: If necessary, irrigate the vagina prior to insertion of the pessary. This will cleanse the vagina of excess discharge and secretions. HCPCS Supply Number A4320 (Irrigation Tray with Syringe, any purpose). 1. Wear dry gloves. When necessary, the entering end of the pessary can be coated with lubricant. 2. Use one finger to depress the perineum. Hold the DONUT almost parallel to the introitus. Guide the pessary into the vagainal vault using a corkscrew motion (see Figure 1). Figure 2 Figure 1 3. The cervix should rest in the DONUT (see Figure 2). 4. After fitting, the patient is told to sit, stand and bear down slightly. Examine the patient while she is in the standing position to ensure the pessary has not shifted position. The patient should not feel the pessary once it is in position. The pessary should not be too loose as it may turn or be expelled, and it should not be too tight as it may cause discomfort. 5. The health care professional should be able to sweep one finger between the pessary and vaginal walls. If there is not enough space to do this, the next smaller size should be tried. If excessive space exists, the pessary will not be effective and may rotate or even be expelled. 6. It is sometimes necessary to refit the patient with a different size or type of pessary after a period of time. Do not assume that a replacement will always be the same size as the previous one. Check the fitting to ensure continued patient comfort and relief of symptoms. The use life of a pessary is limited. Examine frequently for signs of deterioration. CPT CODE Procedure: 57160 HCPCS: A4562 7

PATIENT FOLLOW-UP: Have the patient: Report immediately any difficulty in urinating Report immediately any dis com fort Return within 24 hours for first examination Return for second examination within 3 days Return for examination every 4 to 6 weeks Note: Above schedule of follow-up examinations may be altered to fit the needs of the individual patient. TO REMOvE: Hook one finger inside the center of the pessary. Use the thumb and middle finger to compress the side of the DONUT (see Figure 3). Use the finger of other hand to press down on the perineum. Angle the pessary and pull gently through the introitus (see Figure 1). Figure 3 Note: If necessary, irrigate the vagina after removal of the pessary (and before reinsertion) to cleanse the vagina of excess discharge and secretions. HCPCS Supply Number A4320 (Irrigation Tray with Syringe, any purpose) During each visit, the vagina should be carefully inspected for evidence of pressure or allergic reaction. The patient should be questioned concerning discharge, disturbance of bowel function or difficulty in urinating. It may be necessary to fit another size or an entirely different shape pessary. do NOT assume that a replacement will be the same size as the previous one. Check the fitting to ensure patient comfort and relief of symptoms. At each checkup, the pessary is removed and cleaned. If there are no contraindications, the pessary is reinserted. 8

Gellhorn Fitting Multiple drain Pessary 2-1/4, 2-1/2, 2-3/4, 3 Support for third-degree prolapse/procidentia description: The GELLHORN Fitting Pessary is designed for third-degree uterine prolapse and procidentia. Using the pessary allows a non-surgical approach to uterine prolapse. The Fitting Kit contains the Standard Stem Length of the GELLHORN multiple drain fitting pessary. To properly fit a patient with a GELLHORN pessary it is necessary to have available a minimum of four sizes. The shaded area indicates sizes recommended for office fitting (most common sizes). With these sizes you will be able to fit approximately 85% of patients. Available in the following sizes diameter diameter We recommend the GELLHORN pessary be inserted and removed by a physician or other health care professional. 1-1/2 38mm 2-3/4 70mm 1-3/4 44mm 3 76mm 2 51mm 3-1/4 83mm 2-1/4 57mm 3-1/2 89mm 2-1/2 64mm 3-3/4 95mm Other styles/models of pessaries (all single-patient use only) are available. Consult the CooperSurgical website at www.coopersurgical.com for details. CPT CODE: Procedure: 57160 HCPCS: A4562 INdICATIONS: The GELLHORN pessary is extremely effective in providing the necessary support of third-degree uterine prolapse or procidentia. The cervix rests behind the flat base of the pessary and only the stem shows in the vaginal entrance when the patient does a Valsalva maneuver. The GELLHORN pessary requires a relatively capacious vagina and an intact perineum. CONTRAINdICATIONS: The presence of pelvic infections and/or lacerations Since the GELLHORN pessary is difficult for the patient to remove, it is also contraindicated in any sexually active patient A noncompliant patient Endometriosis has been suggested as a possible contraindication to pessary use Health care professionals should use their professional judgment as to the advisability of using this pessary in a pregnant patient PRIOR TO FITTING: Have the patient empty her bladder before fitting this pessary. Ulcerations and erosions frequently occur in cases of complete prolapse due to irritation of the exteriorized cervix. Whenever possible, reducing the mass and treating the irritation are primary steps before using a pessary. The only method of determining the proper size GELLHORN pessary is trial and error. The holes allow for drainage without reducing the effectiveness of the pessary. The unique silicone folding design facilitates simple insertion and removal. Unlike latex rubber, silicone does not absorb secretions or emit odors. INSTRUCTIONS FOR USE STEP-By-STEP FITTING INSTRUCTIONS FOR THIS PESSARy Note: We recommend the GELLHORN pessary be inserted and removed by a physician or other health care professional. In general, the largest pessary the patient can comfortably accommodate should be fitted. Perform a normal pelvic examination before inserting or fitting any pessary. A first approximation of size can be made by using your fingers to determine the approximate width of the vaginal vault. This will generally get you within a size or two of the proper pessary. Note: If necessary, irrigate the vagina prior to insertion of the pessary. This will cleanse the vagina of excess discharge and secretions. HCPCS Supply Number A4320 (Irrigation Tray with Syringe, any purpose). Available models not included in fitting kit: Folding Silicone Gellhorn Pessaries Gellhorn Pessary (Short Stem) 95% Rigid Silicone Gellhorn Pessary REF MxKPGSS + Size (Short Stem) The Short Stem is approximately ½ inch shorter than the Standard Stem. 9 REF MxKPGRS + Size For third-degree prolapse/procidentia. Note: Stem length should vary based on vault length.

The GELLHORN pessary requires a relatively capacious vagina and an intact perineum. Stem 1. Wear dry gloves. When necessary, lubricate the entering end of the pessary. Hold the Disc pessary as shown in Figure 1. 2. Use one finger to depress the perineum. Figure 1 3. Guide the pessary, inserting it edgewise almost parallel to the introitus (see Figure 1), avoiding the urethral opening while the perineum is strongly pushed downward. Use a corkscrew motion while introducing the GELLHORN into the vagina. 4. Once the large flat disc is past the introitus, push the pessary upward until only the end of the stem shows in the vaginal entrance. The cervix rests behind the flat disc (see Figure 2). Figure 2 5. Have the patient sit, stand and bear down. Examine the patient while she is in the standing position to ensure the pessary has not shifted position. The patient should not feel the pessary once it is in position. The pessary should not be too loose as it may turn or be expelled, and it should not be too tight as it may cause discomfort. Note: If necessary, irrigate the vagina after removing the pessary (and before reinserting) to cleanse the vagina of excess discharge and secretions. During each visit, the vagina should be carefully inspected for evidence of pressure or allergic reaction. The patient should be questioned concerning douching, discharge, and disturbance of bowel function or urination. It may be necessary to fit another size or an entirely different shape pessary. do NOT assume that a replacement will always be the same size as the previous one. Check the fitting to ensure continued patient comfort and relief of symptoms. At each checkup, the pessary should be removed and cleaned. If there are no contraindications, the pessary may be reinserted. 6. The health care professional should be able to sweep one finger between the pessary and vaginal walls. If there is not enough space to do this, the next smaller size should be tried. If excessive space exists, the pessary will not be effective and may rotate or even be expelled. 7. It may be necessary to refit the patient with a different size or type of pessary after a period of time. Do not assume that a replacement will always be the same size as the previous one. Check the fitting to ensure continued patient comfort and relief of symptoms. The use life of a pessary is limited. Examine the pessary for signs of deterioration. PATIENT FOLLOW-UP: Have the patient: Report immediately any difficulty in urinating Report immediately any discomfort Return within 24 hours for first examination Return for second examination within 3 days Return for examination every 4 to 6 weeks Note: Above schedule of follow-up examinations may be altered to fit the needs of the individual patient. TO REMOvE: 1. Use one finger to depress the perineum. 2. Use other hand to grasp the knob, pulling the pessary away from the cervix, turning the pessary so that the disc is almost parallel to the introitus. Using a corkscrew motion, ease the pessary out. See Figure 3. Figure 3 3. Wash the pessary with mild soap and water and rinse thoroughly. 4. Thoroughly rinse the stem channel. 10

95 Corporate Drive Trumbull, CT 06611 USA Phone: (800) 243-2974 Fax: (800) 262-0105 www.coopersurgical.com Made in the USA International Phone: (203) 601-9818 Fax: (203) 601-4747 EC REP EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands MXFITCA-DFU Rev. A 6/13 Solann AB Uddnäsvägen 23 176 76 JÄRFÄLLA SWEDEN +46(0)8 583 560 60 - www.solann.se