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7 CONTENTS PAGE UNIQUE FEATURES explained in full pg. 9 URODYNAMIC REPORTING overview pg. 11 Sample uroflowmetry report pg. 13 Sample consultation report pg. 14 Sample cystometry pressure-flow report (A) Pg. 15 Sample cystometry pressure-flow report (B) pg. 16 Example report pg. 2 Sample video report pg. 21 Nomograms pg. 24 URODYNAMICS CONSUMABLES pg. 27 UROFLOWMETER LEAFLET pg. 31 MAINTENANCE OPTIONS pg. 23

8 Extensive investment in on-going R & D means that the Pico Smart system is always evolving and developing to offer the very latest system capabilities. Of note are the following UNIQUE features:- REPORTING: FULLY CUSTOMISED REPORTING allows the end-user to design their own unique report with the software automatically populating selected fields with test data as well as patient information from the patient entry screen. FLEXIBLE REPORT FORMATS allows reports to be generated in MS Word or PDF allowing easy export to the hospital network TEST SERIES SUMMARY allows a sequence of tests (flow followed by CMG P/F followed by UPP for example) to be report within a SINGLE user-designed report VIDEO IMAGE ADDITION allows the easy selection and addition of video images and their associated data to the main report ACQUISITION: AUTOMATIC REFERENCE HEIGHT ADJUSTMENT with the addition of a third pressure transducer this feature adjusts the reference height of the pressure transducers automatically, eliminating the need to move the transducers to the level of symphysis pubis during periods of the test when the patient is moving. INITIAL BLADDER VOLUME INSERTION allows you to fill the patient on their residual volume, but enter that bladder volume so the infused volume accurately reflect the volume in the bladder for the procedure DATA EXPORT - The Pico Smart software offers advanced data export capabilities providing the end-user with a wide variety of functions including: DATABASE compatible with MS Access and SLQ DATA EXPORT allows study results, graphs and raw data export to MS Office, Power Point and Excel NETWORK COMPATIBILITY with DICOM, HL7 and others STATISTICAL ANALYSIS FACILITY allows quick analysis of patients within the database based on age, sex, complaint and diagnosis either by means of absolute value or percentages.

9 t ( m m : s s. d UNIQUE URODYNAMIC REPORTING FD vlpp ND SD vlpp MCC VLMa p1 ves ml cmh2o p2 abd cmh2o p4 det :.1 1: : : :4.58 6:2.7 cmh2o..... Q ml/s The Pico Smart automatic report generation facility is a very useful and attractive feature. Reports can be extensively customised to suit individual requirements. Each system can incorporate an unlimited number of report formats to accommodate all users requirements. Multiple tests can be analysed within a single report or multiple reports can be generated for a single test Samples of reports already designed are included in this binder.

10 Q (ml / s) Q (ml / s) SAMPLE UROFLOWMETRY REPORT Any logo and contact details can be inserted Patient: Rose Petal ID: 911RP Birth date: 9/7/22 Gender: F Physician: Mr Waterfall Referring Physician: Dr Martin Procedure date: 23/9/213 Uroflowmetry: Waiting Time - Maximum Flow 19.ml/s Time to Maximum 7.7s Average Flow 1.ml/s Flow Time 5% -95% Vol. 2.4s Residual Volume 23ml Flow Time 31.8s Voided Vol. at Max. Flow 95.7ml Voiding Time 33.3s Voided Volume 319.ml 7 Liverpool Nomogram (Q max) 4 Liverpool Nomogram (Q ave) Volume(ml) Printed on: 1/1/ Volume(ml) Petal, Rose

11 SAMPLE CONSULTATION REPORT Any logo and contact details can be inserted PATIENT NAME: Vera Lynne DATE OF BIRTH: 28/1/1965 HOSPITAL ID No: VL1789 PHYSICIAN: Yvonne Mason Vera Lynne is a 48 year old female who complains of urinary leakage with excercise. CYSTOMETRY SUMMARY: The patients bladder was filled at a rate of 5ml/min in a sitting position with first sensation occuring at an infused volume of 47 mls, normal desire occuring at an infused volume of 266 mls and strong desire occuring at an infused volume of 3 mls. Cystometric capacity is 37mls. OBSERVATIONS: Urodynamic Stress Incontinence was demonstrated The cough LPP was 133.8cmH2O Detrusor Overactivity was absent PRESSURE FLOW SUMMARY: The patient voided 275mls at an average flowrate of 8.1ml/s and a maximum flowrate of 18.1ml/s. The detrusor pressure at maximum flow was 21.8cmH2O cm H2O and the average detrusor pressure was 6.5cmH2O cm H2O. The post-void residual volume was 32mls OBSERVATIONS: The flow was continuous and the patient stated that this was a normal void. This void was normal COMMENTS: This patient has failed conservative treatment for her stress incontinence and a tape procedure may be considered Procedure date: 22/1/213

12 t ( m m : s s. d SAMPLE CMG P/F REPORT A page 1 Any logo and contact details can be inserted Patient: Sample, Joe ID: Birth date: 7/9/1946 Gender: M Operator: Mr Smith Referrer: Dr Brown Complaint: Intravesical obstruction; Diagnosis: Date: 11/6/213 Cystometry FD vlpp ND SD vlpp MCC VLMa p1 ves ml cmh2o p2 abd cmh2o p4 det :.1 1: : : :4.58 6:2.7 cmh2o..... Q ml/s Pump Rate 5ml/min Infused Volume 219ml Pves (cmh2o) Pabd (cmh2o) Pdet (cmh2o) Vol (ml) Compl. (ml/cmh2o) 1st Desire (FS) Normal Desire (ND) Strong Desire (SD) Maximum Cys. Capacity (MCC) MEDICA S.p.A.

13 t ( m SAMPLE CMG P/F REPORT A page 2 The patient was filled at 5ml/min with first desire occurring at an infused volume of 88 ml/min, normal desire occurring at an infused volume of 99 ml/min and strong desire occurring at an infused volume of 12 ml/min. The maximum cystometric capacity was 219 mls with a detrusor pressure of 8.9 cmh2o Pressure Flow Study (Voiding Phase) $ VLMa ml p1 ves p2 abd cm H2O 13 cm H2O p4 det cm H2O 2. Q m l/ s 6 : : : : : : Waiting Time 56.3s Opening detrusor pressure 155.9cmH2O Opening Time 53.9s Detrusor pressure at Maximum flow 139.9cmH2O Flow Time 82.3s Average detrusor pressure 15.3cmH2O Voiding Time 99.9s Maximum detrusor pressure 174.cmH2O Maximum Flow 7.1ml/s Closure pressure Average Flow 3.4ml/s Voided Volume 277ml Residual Volume 25ml The patient voided 277ml with a maximum flow rate of 7.1ml/s at a detrusor pressure of 139.9cmH2O and an average flow rate of 3.4ml/s. The average detrusor pressure was 15.3cmH2O Leak Point Pressure The patient leaked at a Vesical LPP of 15.5cmH2O.

14 SAMPLE CMG P/F REPORT B page 1 Any logo and contact details can be inserted Patient: Sample, Joe ID: Birth date: 7/9/1946 Gender: M Physician: Mr Smith Referring Physician: Dr Brown Cystometry: (Filling Phase) Leaked Volume 25ml Infusion Speed 5ml/min Infused Volume 219ml Pves (cmh2o) Pabd (cmh2o) Pdet (cmh2o) Vol (ml) Compl. (ml/cmh2o) 1st Desire (FS) Normal Desire (ND) Strong Desire (SD) Maximum Cys. Capacity (MCC) Pressure Flow Study: (Voiding Phase) Time at Maximum Flow 7.5s Opening Pressure 155.9cmH2O Flow Time 82.3s Pressure at Maximum Flow 15.3cmH2O Voiding Time 99.9s Average Pressure 15.3cmH2O Maximum Flow 7.1ml/s Maximum Pressure 174.cmH2O Average Flow 3.4ml/s Closure Pressure 174.cmH2O Voided Vol. at Max. Flow 176.ml Voided Volume 277ml Residual Volume 25ml Markers Details First Desire Valsalva Leak Point Normal Desire Strong Desire Valsalva Leak Point Maximum Cystometric Capacity Invitation to Micturate Time (hh:mm:ss) :2:5 :2:5 :3:2 :3:26 :5:1 :5:24 :6:2 Pves (cmh2o) Pabd (cmh2o) Pdet (cmh2o) Inf. Vol. (ml) Inf. Speed (ml/min) Printed on: 1/1/214 Sample, Joe

15 p det( c mh2o) SAMPLE CMG P/F REPORT B page 2 I CS Any logo and contact details can be inserted O b s t r u c t e d 6 4 Eq u iv o c a l 2 Un o b s t r u c t e d Q m a x = 7. 1 Pd e t a t Q m a x = Ab r a m s / G r if f it h s Nu m b e r ( Pd e t a t Q m a x - 2 * Q m a x ) = Re s u lt = O b s t r u c t e d Q ( m l/ s ec ) Leak Point Pressure: Vesicle leak Point Pressure 15.5cmH2O Printed on: 1/1/214 Sample, Joe

16 SAMPLE CMG P/F REPORT B page 3 Any logo and contact details can be inserted

17 Example Hospital Urodynamics Clinic Procedure Date: 11/6/213 NAME: CLAIRE SMITH HOSPITAL No: DOB: 1/1/1968 CONSULTANT: MR BROWN

18 EXAMINER: UNS WILKINSON DATE OF CMG: Symptoms/Indications: Relevant Medical History: COMPLAINS OF STRESS INCONTINENCE TVT SEPT 215 Free Void Voided Volume: 89 ml Qmax: 18.1 ml/s Pattern: Continuous Filling phase Filling Speed: 5 ml/min PVR: 25mls Sensations First Desire: 396 mls Normal Desire: 414 mls Strong Desire: 629 mls Maximum Infused Volume including initial residual colume: 696 mls Detrusor Overactivity: NONE Stress Incontinence: DEMONSTRATED +++ Leakage with DO NOT DEMONSTRATED Compliance: NORMAL Voiding Phase Voided Volume: 714 mls Qmax: 25. ml/s Pdet at Qmax: 26. cmh2o cm H2O Pattern: Obstructed / Equivocal / Unobstructed Interpretation: Printed on: 16/2/217

19 Printed on: 1/1/214 Sample, Joe SAMPLE VIDEO REPORT page 1 GENESIS MEDICAL LTD Patient: REFLUX, VIDEO ID: - Birth date: 21/7/1961 Gender: F Notes: Kidney Transplant. Duplex kidney implanted with nephrostomy drained upper pole and hydronephrotic lower pole. Significant residual bladder volume on non-invasive scan - previously tried CIC.? High pressure or poor emptying of bladder? Reflux into transplant kidney. Planning subsequent ante grade lower pole puncture if no transplant VUR Date: 22/7/215 Cystometry Pump Rate 5ml/min Infused Volume 392ml Pves (cmh2o) Pabd (cmh2o) Pdet (cmh2o) Vol (ml) 1st Desire (FS) Normal Desire (ND) Strong Desire (SD) Maximum Cys. Capacity (MCC) Compl. (ml/cmh2o)

20 SAMPLE VIDEO REPORT page 2

21 SAMPLE VIDEO REPORT page 3 Pressure Flow Study (Voiding Phase) Waiting Time 6.9s Opening detrusor pressure 9.9cmH2O Opening Time.s Detrusor pressure at Maximum 6.8cmH2O flow Flow Time 27.8s Average detrusor pressure 19.7cmH2O Voiding Time 33.1s Maximum detrusor pressure 181.8cmH2O Maximum Flow 9.ml/s Closure pressure Average Flow 2.ml/s Voided Volume 56ml Residual Volume 216ml

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23 Pico Smart Urodynamics System software includes a selection of nomograms including:- Liverpool Flow Nomogram ICS Nomogram Solomon Greenwell Nomogram Ghoniem Compliance Nomogram

24 Blaivas-Groutz Bladder Outlet Obstruction Nomogram Hofner Chess Classification

25 June 216 PEBAX is a copolymer polyeter-amide, biocompatible material with high mechanical features that allow the manufacture of catheters with very thin walls. The smooth surface makes catheter introduction easy and painless Connector Colour Meaning Remark NEUTRAL Infusion way To be connected to the pump line BLUE Bladder way To be connected to Pves YELLOW Urethral way To be connected to Pura RED Rectal way To be connected to Pabd * Replacement product of Life-Tech consumables CAT No. Description Qty 2CYS-6LE PEBAX Dual Lumen Catheter, 6Fr with incorporated extension line 1 box of 1 *2CYS-8PE PVC Dual Lumen Catheter, 8Fr 1 box of 1 with incorporated extension line (DLC-7-PT) 2CYS-9E PEBAX Dual Lumen Catheter, 9Fr with incorporated extension line 1 box of 1 *2CYS-6L PEBAX Dual Lumen Catheter, 6Fr 1 box of boxes (DLC-6D) 5+ boxes 2CYS-8P PVC Dual Lumen Catheter, 8Fr 1 box of boxes 5+ boxes *2CYS-9 PEBAX Dual Lumen Catheter, 9Fr 1 box of boxes (DLC-9D) 5+ boxes 2TIE-8P PVC Dual Lumen Coudé tip catheter, 8Fr 1 box of 1 2CYS-6 PIG PEBAX Dual Lumen Pigtail tip catheter, 6Fr 1 box of 1

26 CAT No. Description Qty *1AR-5TI Rectal Pressure Catheter with introducer, 5Fr, Closed PVC 1 box of 1 balloon (RPC-PT) 1AR-5TC Rectal Pressure Catheter, 5Fr, Slit PVC balloon 1 box of 1 (541 &5415) x25 1 box of 25 PEBAX Dual Lumen Rectal Pressure Catheter, 9Fr 3mm Closed Polyisoprene balloon *2AR-9T (RPC-9 / ERPC) 1 box of boxes 5+ boxes CAT No. Description Qty *3omni-8P (DLUPP) PVC Triple Lumen CMG/UPP Catheter, 8Fr 1 box of boxes 5+ boxes 2omni-8PH PVC Dual Lumen CMG/UPP Catheter, 8 Fr 1 box of 1 CAT No. Description Qty CPS-D-6MX Cystometry Pressure Set: Includes PEBAX 2CYS-6LE 6Fr dual 1 box of 1 lumen bladder pressure catheter & 1AR-5TI rectal pressure catheter with introducer CPS-D-8MX Cystometry Pressure Set: Includes PEBAX 2CYS-8PE 8Fr dual lumen bladder pressure catheter & 1AR-5TI rectal pressure catheter with introducer 1 box of 1 CAT No. Description Qty *1PF-5PE PVC single-lumen bladder pressure catheter, 5Fr 1 box of 1 (BPC-S) 1PF-4L PIG PEBAX bladder pressure catheter, 4Fr, Pigtail tip 1 box of 1 1BF-8P bladder filling catheter 1 box of 1 CAT No. Description Qty Extension Line, clear, 18cm 1 box of 1 *EXT-18 (PTTA-C) Box of 5 = 72.5 *EXT-18B (PTTA-B) Box of 5 = 72.5 *EXT-18R (PTTA-R) Box of 5 = 72.5 *SC2 (2-SC) Box of 25 = 4. Extension Line, Blue, 18cm 1 box of 1 Extension Line, Red, 18cm 1 box of 1 2-Way stop cock 1 box of 1

27 *SC3 (4-SCA) Box of 25 = *WTP-LT2 (IPTS-LT2) 3-Way stop cock 1 box of 1 Infusion Pump Tubing Sets for Menfis Pico Smart Urodynamic system Life-Tech Janus 311A (LT2) Pump Infusion Pump Tubing Sets with flow regulator & Line Menfis Pico Smart Urodynamic system Life-Tech Janus 311A (LT2) Pump 1 box of 25 1 box of 25 Infusion Pump Tubing Set for 1 box of 4 Menfis Pico Bright Urodynamic system 1P612E5 Flow Regulator with line 1 box of Cysto-Aid 1 box of Pressure Transducer *WTP-FR- LT2 (IPTS-DC- LT2) WTP-SET MX848x2Sc- Sensex Nova Transducer dome with 2 x stopcocks 1 box of 25 S (discounted to 1 per box if using all Genesis urodynamic catheters) MX96x2Sc- Sensex Logical Transducer dome with 2 x stopcocks 1 box of 5 S BRS-5K Surface Electrodes pre-wired for surface EMG 1 pack of 4 sets of 3 electrodes

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t ( m m : s s. d MEDICA URODYNAMIC REPORTS FD vlpp ND SD vlpp MCC 5 375 25 125 2 7.2 15 1 5 25 13-13 2 4. 15 1 5 2. 15 1 5 VLMa 88.9 89.8 99.6 12.1 28. 219.7 5.2 3.5 4. 11.4 1.1 p1 ves ml cmh2o 3.3 2.6.9.9

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