our HCP IFU in PDF format
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1. Figure 8 CymActive Inserter 11 Gently pull back on the Female Handle to position the Malecot at the bladder neck You should feel some resistance to pulling 12 Rotate and pull the protruding Locking Wire Handle back until the locking wire is fully removed see Figure 9 Locking Wire Figure 9 Removing Locking Wire Locking Wire Handle 10 Rev 02 13 Completely remove the Pusher Tube by pulling back on the Male Handle see Figure 10 oe gt Pusher Tube Figure 10 Removing Pusher Tube 14 Gently remove the Clear Inserter Tube leaving behind the properly placed CymActive I U C 15 Proper placement can optionally be confirmed by using probe ultrasound either trans rectal ultrasound or trans abdominal ultrasound Only the Extraction Tethers may be visible which can be trimmed to a desired length 11 Rev 02 CymActive Actuator 2010 Golgeon Group Inc Figure 11 CymActive Actuator To confirm that the UroValve functions properly e Ask the Patient or healthcare assistant caretaker to place the hand held CymActive Actuator magnet directly in front of his scrotum in order to open the UroValve Urine should flow out Forcefully pressing the CymActive Actuator magnet against the body is not necessary to open the UroValve and may occlude the urethra e Ask the Patient or healthcare assistant caretaker to move the hand held CymActive Actuator magnet2. I U C after discussing with their urologist The 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 Patients with spinal cord injury and a documented history of autonomic dysreflexia should not use the CymActive I U C The CymActive I U C has not been studied in adolescents or children Use in adolescents or children is not recommended Rev 02 5 Precautions 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 The CymActive LU C shall not be re sterilized by the Healthcare Professional A Healthcare Professional should not use excessive force to insert the CymActive LU C Similar force should be used as when inserting an indwelling Foley catheter Difficulty with insertion may indicate a blockage or anatomical irregularity that may inhibit the intended function and operation of the device and should be checked before further attempts at insertion of the CymActive I U C A Healthcare Professional should only use water soluble lubricants to aid insertion of the CymActive LU C An urethoscopy may be performed by a healthcare professional prior to initial insertion to ensure anatomical regularity An ultrasound scan may be performed by a healthcare professional after insertion to
3. away from the Scrotum Urine flow should stop Care should be taken to ensure that each Patient is able to actuate the UroValve properly and without assistance if companion or healthcare aide is not used as shown by at least one successful demonstration prior to leaving the clinic 16 The following instructions must be reviewed with the patient a Advise the Patient that the CymActive LU C has not been adequately evaluated concerning sexual intercourse during the period the device is in the body and it is not known what effect sexual activity may have on the position or function of the CymActive LU C b Advise the Patient to actuate the CymActive I U C at least every 4 6 hours or more often if he has the urge to do so c Advise the Patient to try to fully empty the bladder during each actuation After urine flow stops he should move the CymActive Actuator magnet 12 Rev 02 d e g h away and then place it back near the spot that opened the UroValve to see if he can pass more urine Advise the Patient that he may initially experience a feeling of urgency similar to what is described in the literature for indwelling catheters The use of anticholinergic drugs might be suggested Advise the Patient to keep the CymActive Actuator even when shielded away from objects affected by a magnetic field such as credit cards computer screens etc Advise the Patient that in the unlikely case of
4. any adverse events the Patient should immediately consult the Healthcare Professional Advise the Patient that the CymActive Actuator is required for use but is supplied separately Advise the Patient that the CymActive Actuator should be carried with the Patient at all times In case the Patient has lost the CymActive Actuator he should consult his Healthcare Professional or doctor immediately Advise the Patient not to pull on the tethers if they extend below the meatus 7 2 Instructions for Extraction To remove the CymActive I U C the Healthcare Professional should grasp the two extraction tethers and gently pull Ifthe extraction tethers are internal to the meatus the Healthcare Professional should grasp them with forceps under endoscopic vision and gently pull to remove the device Alternatively the extraction tethers or the UroValve can be grasped cystoscopically using grasping forceps 13 Rev 02 cymactive Ingenion Medical Limited 2014 14 Rev 02
5. cymactive CymActive Bladder Management System CymActive B M S Healthcare Professional User Manual CE MARKING amp mdi oM da muU DO NOT REUSE NUMBER NOTIFIED angenhagener Str BODY 30855 Langenhagen Germany AUTHORIZED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Street London DAMAGED USE Ingenion Medical Ltd DO NOT USE IF CONSULT 64 New Cavendish PACKAGE IS INSTRUCTIONS FOR W1G 8TB UK MANUFACTURER CAUTION STERILISED USING DO NOT RESTERILISE STERILE JEO ETHYLENE OXIDE Rev 02 1 Indications Indications for Use of the CymActive 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 CymActive Inserter 2 1 Healthcare Professional User Manual 3 Patient User Manual Accessory required but supplied separately l The CymActive Actuator 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 The CymActive Actuator is a reusable non sterile device Contacting materials The patient contacting material of the indwelling CymActive U C is silicone The patient contacting material of th
6. e single use CymActive Inserter is PVC Rev 02 2 Product Overview CymActive TM I U C CymActive nserter Figure 1 CymActive Intra Urethral Catheter CymActive I 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 M d Figure 3 CymActive Actuator supplied separately Rev 02 Contraindications Warnings Precautions and Possible Adverse Events 3 Contraindications e A Patient must not have the CymActive Intra Urethral Catheter CymActive I U C inside them when undergoing a magnetic resonance imaging MRI scan e A Patient who is required to maintain an empty bladder by constant free drainage should not use the CymActive I U C e A Patient with a medical implant that could be affected by exposure to a magnet which includes any implanted electromechanical device that the magnet may interfere with such as implanted pulse generators should not use the CymActive I U C If the patient is uncertain this must be checked through medical records before inserting the CymActive I U C e Patients with documented history of sensitivity to silicone should not use the CymActive I U C e A Patient with an estimated length of the urethra from bladder neck to half way down the penile urethra which is greater than 160mm should not u
7. ect positioning ofthe CymActive LU C Rev 02 Note If the estimated length of the urethra from bladder neck to half way down the penile urethra is greater than 160 mm the CymActive I U C should not be used 1 Examine packaging to verify its integrity to ensure sterility of the CymActive I U C has not been compromised If packaging is damaged do not use Remove the CymActive I U C preassembled to CymActive Inserter from packaging after integrity of packaging is verified See Figure 4 Figure 4 CymActive Intra Urethral Catheter CymActive U C preassembled to CymActive Inserter on Polycard Locking Wire Handle Female Handle Figure 5 CymActive Inserter Clear Inserter Tube 2 Slide the Male Handle forward and engage the extended portion into the female handle to collapse the Malecot see Figure 5 Be careful not to rotate the Male Handle Tum the Clear Collar to lock the Male Handle onto the Female Handle see Figure 6 Be careful not to rotate the Male Handle Do not twist Clear Inserter Tube more than 45 degrees in either direction Ensure that the Coud Tip and the Vent both point up and are aligned Rev 02 Coud Tip vent J Male Handle Clear Collar Figure 6 CymActive I U C and CymActive Inserter handles mated 3 Verify that both the Coud Tip and the Vent point up See Figure 6 and that the Malecot is ful
8. ensure the correct positioning of the CymActive I U C Insertion and removal of the device is intended to be performed by healthcare professionals The CymActive I U C should be handled only under aseptic conditions 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 The CymActive I U C should only be used by men who have adequate bladder capacity The Healthcare Professional must review with the patient the instructions listed in 7 1 16 If excessive urine leakage occurs after the patient has removed the CymActive Actuator to allow the UroValve to close the patient should try to open and close the valve 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 Rev 02 After several attempts if excessive urine leakage continues the patient should contact a physician in a timely manner e Ifreduced or no urine flows when the patient tries to empty his bladder he should 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 Act
9. ly collapsed If this is not the case untwist the Clear Collar and separate the Male Handle from the Female Handle Begin again keeping the Coud Tip and the Vent aligned Do NOT rotate the Male Handle 4 Lubricate the CymActive I U C and Inserter with a water soluble lubricant just prior to insertion 5 The patient should be placed in the flex and abduct their knees position for easy insertion 6 Insert the CymActive I U C into the urethra 7 Do not use excessive force to insert the CymActive I U C The need for such force may indicate a blockage or anatomical irregularity that may inhibit the intended function and operation of the CymActive I U C If this does occur urethoscopy may be needed to assess urethral patency 8 Correct placement will be confirmed by urine flow into the Clear Inserter Tube 9 The Inserter Scale See Figure 5 and urine visualization should indicate proper placement of the CymActive I U C in the bladder To insure that the Malecot is fully inserted into the bladder continue inserting the device approximately 4 5 cm before expanding the Malecot Rev 02 10 To expand the Malecot a Unscrew the Clear Collar to unlock and remove it from the Female Handle see Figure 7 Coud Tip m m gt Clear Collar Figure 7 CymActive I U C and CymActive Inserter handles unlocked b Pull the Male Handle back gently to expand the Malecot see Figure 8
10. se the CymActive U C Rev 02 4 Warnings Patients who are mentally and or physically incapable of operating the CymActive B M S in accordance with the instructions for use and do not have access to a full time companion or healthcare aide who is willing and able to assist the Patient with the physical tasks required by the Instructions for Use e g actuation of the valve assembly using the actuator magnet should not use the CymActive I U C Patients who have current signs symptoms and or laboratory confirmation of urinary tract infection should seek appropriate treatment for the urinary tract infection Patients who have a current diagnosis of bladder symptomatic renal or uretheral calculus should not use the CymActive LU 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 prostatic or urethral surgery that has significantly affected the anatomy of the bladder neck and or prostatic urethra should use the CymActive I U C with care The CymActive I U C should be removed by a Healthcare Professional prior to the thirty first 31 day of use The CymActive I U C has not been adequately evaluated for use in patients who have a spinal cord 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
11. uator After several attempts if urine still does not flow or flows at a reduced rate the patient should contact a physician immediately e The CymActive Actuator should be carried with the patient at all times In case the patient has lost the CymActive Actuator please advise them to consult their Healthcare Professional or doctor immediately 6 Possible Adverse Events Possible adverse events associated with the use of the CymActive Bladder Management System CymActive B M S may include urinary tract infection bacteriuria trauma to the urethra or meatus bleeding stricture development pain in the bladder abdomen or urethra urine leakage catheter or valve blockage catheter migration failure ofthe malecot to collapse fully upon removal or failure of both tethers upon attempted removal 7 Summary of Instructions for Use The CymActive Bladder Management System CymActive B M S Instructions for Use for Healthcare Professionals 7 1 Instructions for Insertion of the CymActive Intra Urethral Catheter CymActive I U C Insertion and removal of the device is intended to be performed by a Healthcare Professional only The Healthcare Professional is responsible for proper placement of the CymActiveTM LU C The CymActive I U C should position the UroValve in the proximal penile urethra An ultrasound scan may be performed by a healthcare professional after insertion to ensure the corr
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