RESOURCE GUIDE
Contents
1. When given L Hystosonography CONTINUED ON NEXT PAGE herjoption office cryoablation therapy SAMPLE HER OPTION OFFICE CRYOABLATION THERAPY DATA COLLECTION continuep During Cryoablation e Uterine sound measurement cm e Patient s Menstrual Stage LI Menstrual OI Proliferative L Secretory L Premenstrual e Freeze Pattern and Duration Location of Freeze Length of Freeze PATIENT FOLLOW UP e Data of hysteroscopy e Symptoms of Menorrhagia L Moderate U Severe Q NIL LI None e Patients Menstrual Stage Note For best evaluation results hysteroscopy must be completed during early Proliferative Phase Q Menstrual J Proliferative J Secretory Premenstrual e Hysteroscopy Findings Are myomas present LI Yes UL No If Yes list Location Number Size Il 2 oF Are polyps present U Yes UL No Presence of Endometrium U Yes LU No If Yes specify Location s Other specify e Hysteroscopic Images attached LI Yes U No e Type of treatment to follow Repeat Ablation L Yes L No If Yes specify ablation method Hysterectomy U Yes U No Medication U Yes L No Specify None U her option office cryoablation therapy 23 SAMPLE HER OPTION OFFICE CRYOABLATION THERAPY POST CPROCEDURAISINSITRUCTIONS FOR THE PATIENT You may experience mild to moderate cramping like menstrual cramping and pinkish watery discharge This may last approximately 2 to 3 weeks Use pads not tampons during this time No2. diazepam PO 5 10mg 1 hour prior to procedure Anxiolytic Amnestic Ativan lorazepam PO 1 2mg 1 hour prior to procedure Sublingually 10 min before procedures List includes possible medications that can be used prior to or post procedure for pain management her option office cryoablation therapy HER OPTION RECOMMENDATIONS FOR OFFICE BASED TREATMENTS As is the case with office based procedures such as endometrial biopsy loop electrosurgical excision procedure LEEP hysteroscopy and endometrial ablation physicians that perform Her Option Office Cryoablation Therapy should follow these general recommendations e Vasovagal effects can occur with any manipulation of the cervix Office personnel should be trained in airway management with advanced cardiac life support e Prepare an emergency kit with appropriate pharmacological agents to assist in managing emergency situations be prepared to check blood pressure and provide hemostasis for cervical lacerations e Know your local anesthetics maximum dose To avoid the risk of overdose draw out the maximum dosage Overdose symptoms include dizziness lightheadedness tinnitus depression and systole In case of severe reaction be prepared to administer appropriate pharmacological agents her option 9 sa office cryoablation therapy HER OPTION KEYS TO SUCCESS FOR IN OFFICE COMFORT Patients are more comfortable if the clinician explains what will happen during a
3. if desired to improve ultrasound visualization Beginning Freeze Cycle Depress the negative freeze button on the disposable cryoprobe to start the freeze cycle A green light will appear on the cryoprobe indicating that freezing is occurring Maintain the cryoprobe and tenaculum pressure until the cryoprobe tip temperature reaches minus 60 degrees centigrade Relax tension on the cryoprobe and tenaculum and observe the gradual expansion of the cryozone on the ultrasound using both longitudinal and transverse views The very dark or black area corresponds to the formation of the ice along and extending out from the cryoprobe cryozone formation Ultrasound view Continue the first treatment session for 4 minutes or until the cryozone gets within 5 mm of the serosa of the uterus Depress the positive heat button on the disposable cryoprobe The amber illumination on the keypad The LCD display on the console will read Wait to Move Probe This message will disappear when the cryoprobe tip temperature reaches positive 20 C Her Opticon H j 013 700 11s herjoption office cryoablation therapy owe ko ee HER OPTION PROCEDURAL INSTRUCTIONS conrtTINuveEp Once the Wait to move probe message disappears gently rotate the cryoprobe back and forth and slowly withdraw the cryoprobe from the first cryozone It is not necessary to remove the cryoprobe from the uterus but it
4. cleaned with Betadine A single tooth tenaculum was placed on the anterior lip of the cervix Under ultrasound guidance the Her Option probe was introduced into the uterine cavity and the procedure was performed The following order locations and freeze times were used LOCATION OF FREEZE LENGTH minutes minutes minutes minutes Upon completion of the procedure the instruments were removed and the patient was assisted to another exam room where she was observed Vitals Time BP P The patient tolerated the procedure well and was released in stable condition with her driver along with a copy of the post procedure instructions which were reviewed with her She is to return to the office in months with a menstrual diary PHYSICIAN her option office cryoablation therapy Pre A re SAMPLE HER OPTION OFFICE ECRYOABLATION THERAPY DATA COLLECTION Physician s Name PRIOR TO CRYOABLATION Symptoms of Menorrhagia L Moderate Uterine sound measurement Pre treatment evaluation LJ Ultrasound Uterine Dimensions Width cornua to cornua Length serosa to internal os Endometrial stripe dimensions Data of Cryoablation treatment Q Severe cm LI Hysteroscopy Width Length e Are myomas present LI Yes LU No If Yes list Location Number IL 2 a 4 Are polyps present Yes Q No Septate Uterus U Yes LU No Other specify Pre treatment U GnRH Name Dosage U Dec U None rem ae
5. knowing all the risks benefits of the procedure Preoperative valium 10 mg and motrin 800 mg was given one hour prior to the treatment The patient was placed in the dorsal lithotomy position and a speculum was inserted At that point the paracervical block was administered with marcaine and lidocaine 20 cc in total A single tooth tenaculum was placed on the cervix on the anterior lip in a transverse fashion Cervical dilation was accomplished in standard fashion Cryoprobe was inserted to the fundus of the uterus after uterine sound determined the size of the cavity Cryoablation technology was used and the freeze button depressed Ultrasound was used to monitor the growth of the cryozone Heat button was depressed after 4 minutes and the cryoprobe was repositioned to the the contralateral cornua and freeze button depressed Cryozone was again monitored with ultrasonic guidance Heat button depressed after 6 minutes and cryoprobe removed Pt was comfortable throughout the procedure Speculum removed and pt was given bextra 10mg for 12 days A followup visit was arranged 2 weeks post operative ELECTRONIC SIGNATURE herfoption office cryoablation therapy 20 SAMPLE HER OPTION PROCEDURALINOTE2 PATIENT DOB DATE OF PROCEDURE CONSENTS SIGNED DIAGNOSIS VITALS TIME BP R MEDICATIONS TIME LOT EXP PROCEDURE The patient was placed in the dorsal lithotomy position and a speculum was inserted The cervix and vagina were
6. must be withdrawn out to or near the internal cervical os Reposition the cryoprobe handle to the opposite side of the uterus Apply gentle traction on the tenaculum and gently slide the cryoprobe along side of the cryozone into the untreated cornu If resistance is encountered due to the previous cryozone hold the cryoprobe in position and allow the heated tip to melt through the frozen section into the untreated side Injection of warm saline will facilitate the passage of the cryoprobe 2nd Freeze Cycle Reconfirm by ultrasound that the cryoprobe is near the fundus and into the untreated cornu Depress the minus button to start the second freeze cycle Once the cryoprobe tip reaches minus 60 C tension may be relaxed Observe the developing cryozone as previously outlined in both longitudinal and transverse view Observation of the cryozone growth is best viewed through transverse view Continue freezing for 6 minutes or until the advancing edge of the cryozone gets within 5 mm of the serosa The second cryozone should completely merge with the first cryozone CryoZones merging afier 2nd freeze Depress the plus heat button to begin the heat cycle At 20 C begin rotating the cryoprobe and remove it from the uterus Remove the tenaculum from the cervix Achieve hemostasis of the tenaculum sites if necessary Remove the speculum The Heat Cycle ends when the display panel re
7. sexual activity for 2 weeks post procedure Follow up medications and directions for taking the medications are CALL OUR OFFICE IF YOU DEVELOP ANY OF THE FOLLOWING e Fever of 100 4 or greater e Worsening pelvic pain e Nausea e Vomiting e Greenish vaginal discharge with odor OFFICE PHONE NUMBER Your post procedure follow up visit is scheduled for Date Time herjoption i 24 ij office cryoablation therapy HER OPTION REIMBURSEMENT SERVICES AMS Health Care Affairs HCA team offers reimbursement services for Her Option Our reimbursement team will confirm benefits and fee schedules for each insurance provider The HCA team can provide you with confirmation of e Effective date of coverage e Patient plan specific benefits e Any deductibles or co pays e Patient co insurance percentages e Instructions on any additional request by the health plan To take advantage of the services provided by the AMS Health Care Affairs team call 866 FOR CRYO 866 367 2796 Please note that the benefits quoted are NOT a guarantee of payment and are subject to medical necessity AMS uses reasonable efforts to obtain eligibility and benefit information from the insurance company and all information contained herein represents what has been relayed to AMS from the insurer s representative AMS is not responsible for inaccurate information quoted by the insurance company representative her option office cryoablation
8. ads Standby Press Exit and select Yes to her option office cryoablation therapy 14 HER OPTION PROCEDURAL INSTRUCTIONS conrtTiINuep End Procedure Hor Option Er amiy NEE g 036 00 58s na pinnone f foie Tn oe Post Procedure Instructions Have the patient position herself so that she is fully supported on the exam table Have the assistant place a sanitary pad Allow the patient to rest comfortably for 15 minutes Many physicians send the patient home with an NSAID or Percocet for cramping and schedule an office follow up Patients should be advised that they may conduct normal activities but no strenuous exercise sexual activity douches or tampons until after the 2 week office visit Post Procedure Expectations Cramping post operative Up to 4 weeks of watery discharge usually less Reduction or elimination of menstrual bleeding within first 3 months following procedure True indication of results at 6 months her option office cryoablation therapy aoe 1 IN 4 WOMEN SUFFER FROM HEAVY BLEEDING ARE YOU ONE ORTHEM E Ifyou answer yes to any one of the following questions you may be suffering from heavy bleeding e Does your period last longer than seven days Yes _ No e Do you use more than 3 pads or tampons per day Yes ____No e Do you feel the need to double up on feminine protection Yes ____No e Do you become fatigued due
9. der fullness and visibility of the uterus If necessary add fluid to the bladder to permit proper uterine visualization Gently prep the perineum and if possible the vagina Place sterile vaginal lubricant onto the tips of a large open sided speculum and place into the vagina Open the speculum fully and secure in place Local Anesthesia May not be required with a parous cervix Apply a topical anesthetic either 10 20cc of lidocaine or a topical spray such as Cetacaine may be applied to the cervix and cervical canal Insert a single tooth tenaculum to the anterior cervical lip Apply gentle traction to the cervix and displace to one side of the vagina to facilitate the paracervical injection to the 1st side Paracervical Block Use up to 10 cc of 1 4 bupivacaine on each side at the 4 and 8 o clock positions See Table I for additional information regarding PC Block and toxicity levels Allow 5 minutes for the analgesia to take effect if required dilate the cervix to 6mm TABLE 1 GENERALIZED METHOD OF PERFORMING A PC BLOCK DOSAGE DELIVERED WITH AN INJECTION VOLUME OF 20 30 CC Injection volume cc Dose Delivered mgm 1 4 bupivacaine 20 50 1 4 bupivacaine 30 75 1 2 bupivacaine 20 100 1 2 bupivacaine 30 150 Toxicity level mass dependent 175 her option office cryoablation therapy els HER OPTION PROCEDURAL INSTRUCTIONS coNTINUED Prepare Cryoprobe Depress the power On Off button on the front
10. e sure to drink 2 8 oz glasses of water before you arrive at the office You can plan on your appointment taking about 1 hour The actual procedure lasts for 1 2 hour but you will need to remain in the office for a short period after the procedure You may feel drowsy from the medication administered prior to and during the procedure You should arrange for transportation to and from the procedure The following medications have been prescribed to you Please follow the doctor s instructions in taking these medications Your procedure is scheduled for Date Time If you have any questions prior to your procedure please call our office OFFICE PHONE NUMBER her option office cryoablation therapy 19 SAMPLE HER OPTIONS PROCEDURAL NOTE A sample procedure note is included below for your information A procedural note should be customized for each patient and included in the patient file The collection of patient data can be useful in identifying trends and outcomes across a combined patient population A data collection form is included on the following page Sample Cryoablation Procedure Note PATIENT DATE DR DIAGNOSIS Excessive Uterine Bleeding Menorrhagia TREATMENT Endometrial cryoablation with intraoperative ultrasonic guidance ANESTHESIA Paracervical Block Placement with 0 25 Marcaine and 1 Lidocaine PROCEDURE The patient was brought into the treatment room with a consent form on the chart
11. edure lists of procedure supplies suggested medications and templates to use for your patients and for your medical records We look forward to working with you as you incorporate Her Option into your practice and experience the benefits of Her Option first hand TABLE OF CONTENTS SECTION I PREPARATION FOR TREATMENT Patient Selection amp Contraindications Preparation of Patient amp eB poe factions ihe Pat ae Procedure Supply List Keys to Success for In Office Comfort seee SECTION II PROCEDURE INSTRUCTIONS Pre Procedure D Procedure Steps ie ea Paent e ee Local Anesthesia ancia Prepare Cryoprobe nn Beginning Freeze Cycle eee tea le acetate eee tees SD Cy ae SECTION III PRACTICE FORMS TEMPLATES In Office Patient nonias Her Option Check List Informed Consent Form Pre Procedural Instructions to Patient sn Sample Procedure Note Data Collais Templates nnn Post Procedural Instructions to Patient Se SECTION IV REIMBURSEMENT AMS n Materials Order Form Coversheet SECTION VI SUMMARY OF WARNINGS PRECAUTIONS amp CONTRAINDICATIONS Digital copies supplied on CD SU ON NAW p 11 12 13 14 15 15 G 19 20 25 26 27 28 HER OPTIONS PAripN te sSELECniON OFFICE CRYOABLATION THERAPY PATIENT SELECTION Endometrial ablation is appropriate for patients with abnormal uterine bleeding due to benign disease in whom neither future fertility nor a
12. her option office cryoablation therapy RESOURCE GUIDE Solutions for Life PATIENT BENEFITS PHYSICIAN BENEFITS HEALTH CARE SYSTEM Safe amp effective Easy to learn Minimal discomfort for your patients Appropriately reimbursed herfoption office cryoablation therapy her option office cryoablation therapy In April 2001 Her Option was approved by the FDA as a cryoablative device intended to ablate the endometrial lining of the uterus in pre menopausal women It has been used in over 25 000 procedures in the United States and since its initial introduction Her Option has become the only FDA approved in office ablation therapy for the treatment of menorrhagia Using Her Option within your office is a sound business decision that benefits your patients and practice For patients Her Option is a safe and effective method of ablation Her Option s unique cryoablation technology provides a natural analgesic response which results in minimal discomfort for patients with no IV sedation required Your practice benefits with a procedure that is easy to perform and uses ultrasound guidance for real time visualization and peace of mind Finally Her Option has a higher reimbursement than traditional office procedures and requires a modest capital equipment expense This Her Option Resource Guide was developed to provide you with office tools to help you get started It includes a step by step outline of the proc
13. her than on the day of treatment as the patient consent could be construed to have been signed while under the influence of preoperative medications If a sedative is used patients should arrange for transportation to and from the treatment facility Pre Treatment A thinned uterine lining is recommended prior to treatment The following options may be used e Natural option Timed to the early proliferative phase right after period ends e Medical options Provera or other progestins Lupron 3 to 4 weeks Birth control pills PRE PROCEDURE INSTRUCTIONS FOR THE PATIENT Patients should be provided with a pre procedure instruction sheet A sheet such as the sample included on page 18 will help prepare the patient and help ensure that the day of the procedure goes smoothly The sheet should be customized to include specific patient recommendation and physician office contact information Common office pre procedure patient instructions e On the day of treatment the patient may have a light meal 30 45 minutes prior to treatment e Have the patient arrive at your office approximately one hour prior to the procedure time e The patient should have a comfortably full bladder prior to treatment her option office cryoablation therapy RER OPTIONS PROCEDURE SUPPLY LIST e Regular or large speculum preferably open sided e Tenaculum e One 10cc Luer lock syringe for the paracervical block optional e 50cc sterile saline ro
14. hysterectomy is desired Key patient selection criteria include e Completion of childbearing e Normal pap smear and endometrial biopsy e Absence of uterine abnormalities which distort the uterine cavity to the extent of preventing adequate treatment See Her Option User s Manual 030 02096 001 product labeling for more detailed information CONTRAINDICATIONS The device is contraindicated for use in e Patients who are pregnant or wish to become pregnant in the future e Patients with a known or suspected endometrial carcinoma or premalignant change of the endometrium e Patients with an active genital or urinary tract infection at the time of the procedure e Patients with an active pelvic inflammatory disease e Patients with an IUD currently in place e Patients with an anatomic or pathologic condition in which weakness of the myometrium could exist such as history of previous classical cesarean sections or transmural myomectomy Patients should also have blood tests to understand presence of bleeding disorders or thyroid disease Once the preoperative evaluation has been completed and the patient has failed conservative therapy i e D amp Cs hormones etc she is a candidate for ablation her option ae 5 Pa office cryoablation therapy PRE TREATMENT CHECKLIST PREPARATION OF PATIENT A urine pregnancy test should be performed within 3 4 weeks prior to treatment Consent for treatment should be signed at this time rat
15. intrauterine cavity normal abnormal Contraception OCP tubal ligation partner vasectomy other Consents signed _____ Procedure date scheduled Instructions pre and post given to patient _____ Pre authorization sent Pharmacy number Allergies Scripts Toradol 60mg IM vial disp one _______ Valium 5mg 10mg disp one sig one po one hour before procedure Vicoden ES disp 10 sig one po q 4 6 hours prn pain Darvocet N100 disp 10 sig one po q 4 6 hours prn pain Vibramycin 100mg tabs disp 14 sig one po bid Pre authorization received Patient notified of copay herjoption 17 off ice cryoablation therapy SAMPLE HER OPTION INFORMED CONSENT ig hereby authorized the physicians of to perform cryoablation of my uterus This procedure has been clearly explained to me The alternatives to this procedure have been discussed The physician has answered my questions to my satisfaction I understand that the purpose of cryoablation is to cause the sloughing off of the endometrium the lining of the uterus I understand that I may feel discomfort and or cramping during the procedure I understand that certain complications can sometimes result from cryoablation These complications include but are not limited to bleeding uterine scarring uterine perforation with injury to inter abdominal contents and infection of the uterus or other pelvic organs Some complications may result in a need for a hyste
16. ist e Endometrial ablation does not eliminate the potential for endometrial hyperplasia or adenocarcinoma of the endometrium and may mask the condition e Patients who undergo endometrial ablation procedures who have previously undergone tubal ligation are at increased risk of developing post ablation tubal sterilization syndrome e There is the potential for thermal injury to adjacent organs if the cryozone extends beyond the serosal surface of the uterus e As is the case with any office based procedure physicians should be prepared for an emergency General recommendations for such emergencies include having an emergency kit on hand with appropriate pharmacological agents Office staff should be trained in airway management and advanced cardiac life support For a complete list of indications contraindications warnings and precautions refer to the Instructions for Use for the HerOption Cryoablation Therapy System her option office cryoablation therapy ga es For more information visit us atwww AmericanMedicalSystems com AMS Solutions for Life 10700 Bren Road West 2007 American Medical Systems Inc Minnetonka MN 55343 USA All rights reserved Printed in USA U S Toll Free 800 328 3881 Phone 952 930 6000 Fax 952 930 6157 Order Number 23700025D 08 07 US
17. nd after the procedure Knowing what to expect can alleviate much of the anxiety patients feel throughout the treatment and recovery periods Here are additional recommendations for providing in office comfort e Provide a procedure room that is quiet relaxing and comfortable e Provide a blanket and pillows to make the patient more comfortable e Turn down the lights e Provide soft music in the room or on head phones to calm her nerves e Encourage the patient to eat a light meal before the procedure so she is not hungry e Encourage the patient not to void prior to the procedure so that her bladder is naturally full and a Foley is not required Encourage staff to be V Calm friendly empathetic gentle and unhurried V Attentive to the patient listen to her and make her needs their first priority vV Respectful of the patients privacy and confidentiality her option office cryoablation therapy ee i E HER OPTION PROCEDURAL INSTRUCTIONS The following instructions are designed to provide you a step by step overview of the Her Option procedure For the comprehensive instructions for use please see the owners manual I PRE PROCEDURE OPTIONS e Valium or Ativan one hour before e Toradol or other NSAIDs may be used II PROCEDURE STEPS Position Patient Position the patient on the exam table and place in stirrups or footrests Reconfirm uterine position by pelvic exam An abdominal ultrasound is performed to note blad
18. of the console power up will take approximately 3 minutes LCD display will show the Her Option logo and two choices select start to begin the procedure ay Se her option The display panel directs the user to Please Attach New Disposable At this time remove the disposable cryoprobe from the tray Connect the cryoprobe sheath over the cryoprobe and lock it into place Pull the sterile plastic sheath over the handle and black flex line Initiate PreCool when prompted by the console LCD panel Caution It is very important that the PreCool cycle be conducted using the disposable cryoprobe that will be used for the treatment Test cryoprobes should NOT be used for PreCool cycle Ultrasound Grasp the tenaculum and apply gentle traction to straighten out the uterus Carefully insert the cryoprobe slowly into the uterus and observe its path on the ultrasound Advancing the cryoprobe gently touch the right cornual area of the uterine cavity and confirm sonographically that the probe is inside the uterine cavity in a longitudinal view You can confirm the probe is on the right sonographically in the transverse view herjoption 12 office cryoablation therapy HER OPTION PROCEDURAL INSTRUCTIONS conrtTiInuep Apply gentle traction to the tenaculum and hold the probe with the tip in the right cornual area Inject approximately 5 cc of sterile saline through the bottom injection port
19. om temperature optional e Ultrasound machine with abdominal transducer e Ultrasound gel e Topical cervical anesthetic e g Hurricaine optional e 4x4 sterile gauze and long Q tip e 30cc 0 25 bupivacaine optional e Uterine sound e Uterine dilators up to 6mm e Alcohol wipes e For paracervical block Reusable needle extender and a disposable 22 gauge standard needle or one extended dental needle optional e Betadine or other topical antiseptic for vaginal prep e Gloves etc her option ne vi a office cryoablation therapy HER OPTION TYPICAL MEDICATIONS USED TYPE OF DRUG DRUG NAME GENERIC USUAL DOSE amp TIMING Local Anesthetic Lidocaine Xylocaine 15 20 cc of 5 1 solution in PC Block Short acting Local Anesthetic Marcaine Bupivacaine 10 20 cc of 25 solution in PC Block Longer acting for women who can t take anti inflammatory Analgesic NSAID Ibuprofen PO 600 800mg 1 hour prior to procedure and up to 1 day post procedure Analgesic NSAID Aleve naproxen PO 800mg 1 hour prior to procedure and up to 1 day post procedure Analgesic NSAID Toradol ketorolac PO 20mg 1 hour prior to procedure IM 30 60mg Analgesic Narcotic Vicodin PO 1 2 tablets 1 hour prior to 500mg acetaminophen procedure and up to 1 day post w 5mg hydrocodone procedure Analgesic Narcotic Vicoprofen PO 1 tablet 1 hour prior to procedure and up to 1 day post procedure Anxiolytic Amnestic Valium
20. rectomy The medical literature has indicated that the general success rate for this procedure in treating abnormal vaginal bleeding is approximately 90 percent Twenty to thirty percent 20 30 of the patients will experience total resolution of their periods Cryoablation may not decrease menstrual cramps or pain Cryoablation is not a form of birth control Pregnancy is still a possibility after cryoablation Effective birth control continues to be important after this procedure Should pregnancy occur there is a higher than normal chance of ectopic tubular pregnancy miscarriage premature delivery or birth defects that can be dangerous for both mother and fetus Following the procedure I have been informed that I can expect as a normal result of the procedure a heavy watery discharge for up to 1 3 weeks I understand that intercourse should be avoided until the discharge stops I understand that my first menstrual cycle after this procedure may be heavier than normal with passage of tissue I have read the above and I fully understand the nature purpose risk and alternatives to this procedure and I am willing to undergo the procedure WITNESS PATIENT DATE her option office cryoablation therapy ge o E SAMPLE HER OPTION OFFICE CRYOABLATION THERAPY PRE PROCEDURAL INSTRUCTIONS You may have a light meal prior to coming to the office if desired You will need to have fluid in your bladder for the procedure so b
21. therapy 5 HERSOPTION SUPPORM MATERIALS We want to help make your office ablation practice a success To find out what practice marketing resources are available please contact your Her Option representative To order support material contact Customer Service 1 800 328 3881 Literature Hotline x7614 or Fax request by filling in quantities and using the cover sheet on the following page ve DOS AMS SUPPORT MATERIALS ORDER FORM COVERSHEET Customer Service Fax 1 800 366 9035 To Literature Hotline x7614 FROM DATE SHIP To PAGES INCLUDING COVER her option SUMMARY OF WARNINGS PRECAUTIONS AND CONTRAINDICATIONS FOR THE HER OPTION CRYOABLATION THERAPY SYSTEM The Her Option Cryoablation Therapy System is a closed cycle cryosurgical device intended to ablate the endometrial lining of the uterus in pre menopausal women with menorrhagia or excessive bleeding due to benign causes for whom childbearing is complete e The device is contraindicated for patients who are pregnant or who desire to become pregnant in the future patients with a known or suspected endometrial carcinoma or premalignant change of the endometrium or have an active genital or urinary tract infection e The device is contraindicated for patients with active pelvic inflammatory disease PID an intrauterine device IUD currently in place and patients with any anatomic or pathologic condition in which weakness of the myometrium could ex
22. to your heavy bleeding Yes ___No e Does your heavy bleeding affect your social athletic or sexual activities Ys _ No e Do you miss work because of your periods Yes ___No e Do you pass clots during your periods Ys _ No e Do you avoid leaving your home for fear of accidents Ys _ No e Do you avoid wearing light colors during your period Yes No e Has medication birth control pills failed to help your heavy bleeding Yes No E Are you interested in learning more about a one time treatment for heavy bleeding that is safe non surgical and may be provided in the comfort of your physician s office Yes No E After you have completed this patient questionnaire please present this to your physician and ask him her to discuss your heavy bleeding options including whether the Her Option Office Cryoablation Therapy is right for you her option office cryoablation therapy a 1G SAMPLE HERCOP TION CHECK lis Patient Name DOB When scheduling Her Option initial next to each item below when they have been completed If results of tests are not clear review them with the scheduling physician Check with the physician regarding what scripts she he wants the patient to have Remember to check the patients allergies Consents must be signed before the patient takes any medications the day of the procedure ____ Endometrial Biopsy normal abnormal Ultrasound Sonohysterogram or Hysterscope
Download Pdf Manuals
Related Search