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1. each Patient is able to actuate the UroValve properly and without assistance if companion or healthcare aide is not used as shown by one successful demonstration prior to leaving the clinic a Position yourself as you would do if you have to pass urine b Remove the CymActive Actuator magnet from its pouch and hold it in the hand you write with Grasp the shaft of your penis in the other hand c To empty your bladder i Move the CymActive Actuator magnet under the shaft of the penis near the scrotum to open the UroValve You should be able to pass urine Forcefully pressing the CymActive Actuator magnet against the body is not necessary to open the UroValve and may block the flow of urine through the urethra Rev 02 iii lv vi vii 2010 Golgeon Group Inc Figure 4 CymActive Actuator In the event of reduced or no urine flow try to open and close the UroValve several times by moving the CymActive Actuator magnet under the shaft ofthe penis near the scrotum moving the Actuator magnet slightly left right up down or in and out and then moving the Actuator away from the area After several attempts if urine still does not flow or flows at a reduced rate you should contact your doctor immediately When the flow of urine stops move the CymActive Actuator magnet away to close the UroValve Move the Actuator magnet back into position to open the UroValve again to see2. is PVC Rev 02 2 Product Overview CymActive TM I U C CymActive nserter Figure 1 CymActive Intra Urethral Catheter CymActive U C preassembled to CymActive TM Inserter UroValve Coud Tip inserted into Valve Cavity Figure 2 CymActive Intra Urethra Catheter CymActive U C with UroValve d Figure 3 CymActive Actuator supplied separately Rev 02 Contraindications Warnings Precautions and Possible Adverse Events 3 Contraindications Circumstances when it should not be used This device contains metal Therefore a Patient must not have the CymActive Intra Urethral Catheter CymActive I U C inside them when undergoing a magnetic resonance imaging MRI scan A Patient who is required to keep their bladder empty by constant free drainage should not use the CymActive I U C A Patient with a medical implant that could be affected by exposure to a magnet such as any implanted electromechanical device that the magnet may interfere with such as implanted pulse generators should NOT use the CymActive I U C Check with your doctor before using this device if you think you may have a medical implant that could be affected Patients with documented history of sensitivity to silicone should not use the CymActive I U C A Patient with an estimated length ofthe urethra from bladder neck to half way down the penile urethra which is gr
3. cymactive CymActive Bladder Management System CymActive B M S Patient User Manual CE MARKING amp mdi Europa GmbH DO NOT REUSE Langenhagener Str 71 NUMBER NOTIFIED BODY 30855 Langenhagen Germany AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Ingenion Medical Ltd DO NOT USE IF CONSULT 64 New Cavendish PACKAGE IS INSTRUCTIONS FOR Street London DAMAGED USE W1G 8TB UK MANUFACTURER CAUTION EIU DE DO NOT RESTERILISE STERILE EO Rev 02 1 Indications Indications for Use ofthe CymActiveTM Bladder Management System CymActive B M S The CymActive B M S is indicated for use for urinary drainage in adult men who require a device to manage bladder drainage for urinary retention Contents 1 1 CymActive Intra Urethral Catheter CymActive I U C pre assembled to CymActiveTM Inserter 2 1 Healthcare Professional User Manual 3 Patient User Manual Accessory required but supplied separately 1 The CymActive Actuator e The CymActive Actuator is an accessory and is required and intended only for use with the CymActive Bladder Management System e The correct handling is described in this instruction for use e The CymActive Actuator is a reusable non sterile device Contacting materials The patient contacting material of the indwelling CymActive I U C is silicone The patient contacting material of the single use CymActive Inserter
4. d injury This device may not stay in the proper position in patients with spinal cord injury A patient with urinary retention due to a spinal cord injury should only use the CymActive I U C after discussing with their urologist This device should only be used in a patient with spinal cord injury below T6 who has a good perianal reflex as determined by the physician e Patients with spinal cord injury and a documented history of autonomic dysreflexia should not use the CymActive LU C e The CymActive I U C has not been studied in adolescents or children Use in adolescents or children is not recommended 5 Precautions Checks that should be done before use of the CymActive B M S CymActive I U C e A Healthcare Professional should examine packaging verifying its integrity to ensure sterility of the device has not been compromised If packaging is damaged do not use the CymActive I U C e The CymActive LU C shall not be re sterilized by the customer e Insertion and removal of the CymActive LU C is intended to be performed by healthcare professionals e The CymActive I U C should be handled only under aseptic conditions prior to and during insertion e If Patient has been advised to use prophylactic antibiotics during invasive procedures the Healthcare Professional will judge the potential risk of using the CymActive I U C and judge the need for antibiotic prophylaxis on insertion e Th
5. e CymActive I U C should only be used by men who have adequate bladder capacity e The Healthcare Professional must review with the Patient the instructions listed in section 7 1 e The CymActive Actuator should be carried with the patient at all times In case you have lost the CymActiveTM Actuator please consult your Healthcare Professional or doctor Rev 02 6 Possible Adverse Events Things that may go wrong and that you should look out for when fitted with the CymActive B M S Possible harm associated with the use of the CymActive B M S may include urinary tract infection damage trauma to the urethra or meatus blood in the urine stricture development pain in the bladder abdomen or urethra urine leakage catheter or valve blockage catheter migration difficulty in removing the CymActive U C or the strings may snap upon attempted extraction In the unlikely case of any adverse events you should immediately consult the Healthcare Professional If you feel pain or discomfort in your bladder abdomen or urethra you should contact your doctor If you have to keep opening the UroValve many times in a short period of time for example more than once every two hours because you feel that you have to pass your urine urgently then you should contact your doctor If excessive urine leakage occurs after removing the CymActive Actuator to allow the UroValve to close try to open and close the Ur
6. e during the period the device is in the body It is not known what effect sexual activity will have on the function and positioning of the CymActive LU C Actuate the CymActive I U C at least every 4 6 hours or when you have the urge to do so Fully empty your bladder during each actuation You may initially experience a feeling of urgency similar to what is described in the literature for indwelling catheters The use of anticholinergic pharmaceuticals might be recommended Keep the CymActive Actuator even when shielded away from objects that might be affected by a magnetic field such as credit cards computer screens watches etc The CymActive Actuator is required for use but is supplied separately The CymActive Actuator should be carried with the patient at all times In case you have lost the CymActiveTM Actuator please consult your Healthcare Professional or doctor immediately Rev 02 cymactive Ingenion Medical Limited 2014 10 Rev 02
7. eater than 160mm should not use the CymActive I U C This must be determined by the urologist or healthcare professional responsible for inserting the device 4 Warnings Things men using the CymActive B M S should be aware of Patients who are unable to understand the instructions for use or operate the CymActive B M S themselves and do not have a full time companion or caretaker who the patient is willing to let operate the device and who is willing and able to follow the Instructions for Use and assist the Patient e g open the UroValve using the CymActive Actuator should not use the CymActive I U C Patients who have current signs symptoms and or laboratory confirmation of urinary tract infection should have this treated and resolved before insertion Patients who have a current diagnosis of bladder stones symptomatic renal or urethral calculus should not use the CymActive I U C Patients with a history of bladder surgery within the past two months should not use the CymActive I U C Patients with a history of previous prostatic or urethral surgery should speak to their doctor about this before using the CymActive LU C as it may not stay in the proper place after insertion Rev 02 e The CymActive U C should be removed by a Healthcare Professional prior to the thirty first 31 day of use e The CymActive I U C has not been adequately evaluated for use in patients who have a spinal cor
8. if you can pass any more urine Try this several times until you feel that you have emptied your bladder completely In the event excessive urine leakage occurs after you have removed the CymActive Actuator to allow the valve to close try to open and close the UroValve several times by moving the Actuator magnet under the shaft ofthe penis near the scrotum moving the Actuator magnet slightly left right up down or in and out and then removing the Actuator After several attempts if excessive urine leakage continues contact a physician in a timely manner Replace the CymActiveTM Actuator magnet in the pouch Do not bring the CymActive Actuator magnet near to a computer watch or credit card as it is a very strong magnet and could cause damage The CymActive I U C should be removed by a Health Care Professional prior to the thirty first 31 day ofuse Rev 02 viii Ifinstructed to have a Magnetic Resonance Imaging MRI Scan you must tell the doctors looking after you that you have a CymActive I U C in your urethra The CymActive U C must be removed before the MRI Scan because it contains metal 7 1 The following should be discussed with your Healthcare Professional Further matters that you may wish to discuss with your doctor or nurse before having the CymActive U C inserted a b c d e g The CymActive I U C has not been adequately evaluated concerning sexual intercours
9. oValve several times by moving the Actuator magnet under the shaft of the penis near the scrotum moving the Actuator magnet slightly left right up down or in and out and then removing the Actuator After several attempts if excessive urine leakage continues please contact a physician in a timely manner If reduced or no urine flows when trying to empty the bladder try to open and close the UroValve several times by moving the Actuator magnet under the shaft of the penis near the scrotum moving the Actuator magnet slightly left right up down or in and out and then removing the Actuator After several attempts if urine still does not flow or flows at a reduced rate please contact a physician immediately Rev 02 7 Summary of Instructions for Use The CymActive Bladder Management System CymActive B M S Instructions for Use for Patients Insertion and removal of the CymActive Intra Urethral Catheter CymActive I U C is intended to be performed by a Healthcare Professional only You should practice using the CymActive Actuator magnet in the doctor s office after the CymActive I U C is inserted to make sure you can do it well If you need assistance the person providing the assistance your companion or caretaker should practice using the CymActive Actuator magnet to make sure they know how to help you empty your bladder before leaving the doctor s office Care should be taken to ensure that
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