EzeePZee Portaflow User Guide Ver 6.4 Nov 2007

Portaflow™ User’s Guide

Table of Contents

Page

Explanation of Symbols Important Information Cautions Component List Description Installation -Urinal Installation - Display Panel Installation using the toilet chair Operation of Portaflow™ Operating the Display Panel Loading the paper roll Logger unit Calibration check Battery Charging & disposal Cleaning Handling and care Safety and performance Warnings and Precautions Troubleshooting

1 3 4 4 5 6 7 8 9 10 12 13 14 15 16 17 17 18 19

Avoiding or identifying and resolving adverse electromagnetic effects

20

Technical Support Warranty Disclaimer of additional guarantees Technical information

20 21 21 22 Page 3 of 24

Portaflow™ User’s Guide

Important Information Product Description The EzeePzee Portaflow™ Urological device is a sophisticated computerised Uroflow unit that produces error corrected flow graphics with an interpretative nomogram. Notice To All Operators The Portaflow™ urological device should be operated only by individuals who have been trained and authorized by their physician or the institution providing care for the patient. All operators should read this Operator’s Manual prior to using the Portaflow™ urological device. Do not attempt to operate the Portaflow™ urological device until all instructions and procedures in this manual have been read and thoroughly understood. Failure to comply with instructions may compromise the performance of the instrument. Biological Safety To date, exposure to radio frequency emissions has not been shown to produce adverse effects. Radio emissions, however, should be used only by medical professional when clinically indicated, using the lowest exposure times possible commensurate with clinical utility. The radio output power of the Portaflow™ urological device is not user-adjustable and is limited to the minimum level necessary for effective performance. Data on output levels can be found in the “Technical Description” section of this manual. Statement of Prescription This device should only be used by a Physician or a trained operator on the order of a Physician. Statement of Intended Use The Portaflow™ urological device is intended for use only as an analytical tool and is not intended for direct diagnosis or monitoring of vital physiological processes.

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Portaflow™ User’s Guide Warning: There is a possible explosion hazard if the Portaflow™ urological device is used in the presence of flammable anaesthetics.

Component List

1.

Urinal or Toilet Chair with stand

2.

Display Panel

3.

Logger

4.

Interconnection Lead(s)

5.

Power Supply (Display Panel Charger)

6.

Mains Lead (1 of)

7.

Jugs (2 of)

8.

Paper printer roll

9.

Calibration Weight

10. Instruction manual

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Portaflow™ User’s Guide

Description The microprocessor controlled Display Panel contains electronics which computes and manages the Portaflow™. Control of the Portaflow™ is via the Liquid Crystal Display (LCD) and menu access keys (<, > and SET). The results are printed out via an inbuilt printer. The LCD provides an informative display indicating the status of the Portaflow™ and provides instructions for interactive procedures such as calibration. The Display Panel contains a rechargeable battery pack which is monitored by a battery management unit, and displays warning messages such as ‘Battery Low’ on the LCD display. There is also an audible alarm contained within the unit that is used to alert of “low battery” or announcing “Shutdown”. The Display Panel can either be mounted on the upright stand of the Portaflow™, the side stand of the Portaloo, or mounted on a small table top stand or wall bracket. The Logger unit itself receives its power from the battery of the Display Panel, the Light Emitting Diodes (LED’s) providing information as to the Loggers status. The Logger contains a highly sensitive load cell, which measures the mass of urine being collected in the jug against time and compares the results to a calibration curve to produce the flow results. The Portaflow™ system is activated by placing the jug onto the logger. On activation the logger goes into autozero after which the system is ready to measure. The logger will now remain in standby until it detects a change in weight such as when a urine void has been started. Once a void has been initiated, then the logger will start transmitting data in real time to the Display Panel and will continue for a set time after the flow has ceased to ensure all drips are recorded and any hesitancy included. The results are then calculated and printed as required. If after activating the Portaflow™, it is not subsequently used, then after one hour the unit will automatically shutdown. There is a countdown procedure that is supplemented with an audible alarm and status message on the LCD. It is possible to use the menu buttons to toggle between male and female, by pressing the SET key, without accessing the hidden menu.

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Portaflow™ User’s Guide

Installation of the Urinal 1) Feed the lead with the red plug through the grommet at the rear of the urinal just below the lower fixing bracket (fig 1 and 2). 2) Locate the polarising key on the plug and hold the plug with the keyway towards the bottom (fig 3).

fig 1

fig 2

3) The plug has a latching function so push the plug into the rear of the logger until a click is heard (fig 4). Do not try to rotate the plug. To remove the plug, hold the grey collar and pull, gently 4) Place the logger centrally in the urinal recess (fig 5).

fig 3

fig 4

fig 5

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Portaflow™ User’s Guide

Installation of the Display Panel 1) The display panel is mounted on the top of the urinal stand by just sliding the display panel rectangular section over the top section of the urinal stand (fig 6). No fixing is necessary. 2) The cable for the display panel passes up through the main central pillar and emerges out through a hole towards the top of the pillar. Locate the plug and again with the keyway facing down on the plug push the plug into the socket on the rear of the display panel (fig 7) until a click is heard. Do not try to rotate the plug. 3) Place the jug on the logger (fig 8). The ‘Ready’ lamp will be illuminated on the front of the logger. Check ‘READY’ is displayed on the display panel LCD along with the selected gender. If the male/female is wrong just press the right hand button “SET” to select. If the display is incorrect check the plugs are pushed well in.

fig 6

fig 7

4) Check that there is paper in the printer (fig 9). If there is no paper see page 12, ‘loading the paper roll’. If the system is being used for the first time, the battery in the display panel will need charging. (See section ‘Charging the battery’, page 15). If the system is not going to be used immediately, remove the jug to switch off to conserve power. (See page 9)

fig 8

The system will automatically turn off after 1 hour. To restart the system replace the jug onto the logger.

fig 9 Page 8 of 24

Portaflow™ User’s Guide Installation using the toilet chair Installation of the toilet chair is similar to the urinal. 1) Locate the toilet chair in the position to be used (fig10) 2) Place the funnel into the position shown in (fig11) 3) Place the logger directly beneath the chair (fig 12) 4) Locate the polarising key on the Red plug and hold the plug with keyway towards the bottom (fig 3). 5) The plug has a latching function so push the plug into the rear of the logger until a click is heard (fig 4). Do not try to rotate the plug.

fig 10

6) The display panel is mounted on a separate stand 7) Locate the Yellow plug and again with the keyway facing down on the plug push the plug into the socket on the underside of the display panel until a click is heard. Do not try to rotate the plug. 8) Place the jug on the logger (fig 13). “Ready” will be displayed on the display panel and the ‘Ready’ lamp will be illuminated on the front off the logger indicating that the system is ready for use. If displays are incorrect, check the plugs are pushed in far enough to latch.

fig 11

If the system is being used for the first time, the battery in the display panel will need charging. See section ‘Charging the battery’, page 15). If the system is not going to be used immediately, remove the jug to switch off to conserve power.

fig 12

The system will automatically turn off after 1 hour. To restart the system replace the jug onto the logger.

fig 13 Page 9 of 24

Portaflow™ User’s Guide

Operation of the Portaflow™ 1) To prevent the urinal moving during use, position the urinal in the required place and lock all four castors by pressing the black lever down with your foot (fig 14).

fig 14

2) To switch the device on, place the jug onto the logger unit. Confirm that the display is now activated and shows a ‘Ready’ on the display

fig 15

3) The patient may now void into the Urinal. The screen will now display ‘Measuring flow’ 4) Within 30 seconds after the flow has been completed, the printer will automatically print the flow (fig 16) 5) The graph will be scaled according to the settings (see menu 4 page 11). 6) Remove the jug and either shutdown the unit by holding down the “>” button or leave for automatic shutdown (if unused for 1 hour).

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fig 16

Portaflow™ User’s Guide

Display Panel Operation The menu system allows for customisation and identification of the report, printout options, changing gender for the nomogram, calibration check and shutdown of the Portaflow™. To access the Menu Programme press the “<” and “>” buttons together.

fig 17

To navigate through the menu’s use “<” to go backwards in the list (Or decrease the alphanumeric choice), “>” to travel forwards (or increase the alphanumeric choice) and “SET” to action the selection or enter the change. The following functions can be set and changed within the Menu system:1.

2.

3.

1. Male options: 2. Female 3. Back Calibration 1. Calibrate check options: 2. Last Calibration 3. Calibrate 4. Back Date & Time 1. Date options: options:

fig 18

Gender

2. Time

SET to implement SET to display (Access code required*)

1. Year 2. Month 3. Day 4. Back 1. Hour options: 2. Minutes 3. Back

3. Back Page 11 of 24

Portaflow™ User’s Guide 4.

Print Settings 1. Nomograms 1. Yes * options:options:- 2. No 3. Back 2. Assessment 1. Yes * options:- 2. No 3. Back 3. Comments 1. Yes * options:- 2. No 3. Back 5. Flow rate scale 1. Male flow options:- 2. Female flow 3. Back 5. Print Last Flow SET to implement 6. Print Previous > moves to next flow, < moves to previous, SET to print Flows 7. Smoothing 1. Yes SET to highlight options:- 2. No 3. Back 8. Text Settings 1. Centre 6 characters < to decrease > to 40 characters increase, SET to options:- 2. Hospital Name implement

9.

Language 1. English options:- 2. Swedish 2. Back 10. Radio (optional) 1 Configure options:- 2. Back 11. Smartcard(optional) 1 Configure options:- 2. Back 12. Flow total 1 Configure options:- 2. Back 13. Shutdown SET to implement

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Starts countdown

Portaflow™ User’s Guide

Loading the Paper roll The roll should be dropped into the loading mechanism such that the printer roller is fed from underneath the bulk of the roll. The heat sensitive side of the paper is on the outside face of the roll The paper roll is loaded most easily just before the unit has been turned on.

fig 19

Flip the printer cover down and press the bar on the right side with “Push” marked on it (fig 19). This releases the printer mechanism and allows it to drop forward for easy access (fig 20). To remove the remains of an old roll, pull forward the top part of the green lever (fig 21) to release the roller. Remove any old paper and push back the green lever.

fig 20

Press the SET button to turn the unit on, offer the new paper up to the roller mechanism and the paper will now be automatically taken under the roller. Press the printer mechanism back into the box by again pressing on the bar marked “Push” (fig 19) locating the mechanism securely back into the housing again. Press “Feed” on the left of the printer to feed out extra paper. Feed through the slot in the printer cover and close the front cover. Tear off any excess paper protruding from the roller. The printer is now ready for use.

fig 21

On turn on and for the first 30 seconds after start up the printer can be controlled manually by using the small buttons on the left of the printer.

fig 22

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Portaflow™ User’s Guide

Logger Unit The logger is a precision made piece of equipment and care should be taken not to drop or damage the unit. If the logger is accidentally dropped during cleaning then the logger should be checked to see if it is still in calibration. (see page 14 for checking calibration.) Power is supplied to the logger from the Display Panel via this rear socket. The Logger is turned on by placing the jug onto the logger. It remains ready to record a flow the whole time the jug remains on the unit. When the jug is removed the logger will enter a standby phase after which it will then turn itself off.

fig 23

Flow Indicators. The Logger unit has two banks of lamps across its front face to help facilitate troubleshooting. With no pot on the logger no power will be supplied to the logger so no lights will be displayed. Placing the pot on the logger will cause the logger to autozero. During the autozero phase, which takes about one second, all the lamps are displayed in sequence from right to left. After the autozero phase has been completed the “Ready” lamp is continuously displayed. As soon as a flow is sensed the “Flow” lamp will be illuminated and continue to be illuminated during the flow. When voiding ceases, the logger will wait for further evidence of a continuation of the flow and if no further urine is passed within 30 seconds the logger then transmits the data to the display panel. During transmission the “Ready” lamp is extinguished and the “Full” lamp illuminated and will remain lit during the data transmission, which takes less than a second.

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Portaflow™ User’s Guide

Calibration Check The logger unit is extremely stable and requires only a periodic calibration check, unless there is some reason to doubt the reliability of the logger (such as possible damage caused by dropping the unit for example). The device advises automatically that a calibration check is needed via the display (every sixty days) Before starting calibration check ensure the brass calibration weight is on hand. If at any time you need to exit the calibration mode, Press “<” and “>” buttons simultaneously to return to the “Ready” mode.

Press the “<” and “>” buttons simultaneously to enter the main menu (fig 24). “Main menu” and “1. Gender” will be indicated Press the “<” or “>” buttons to scroll through the menu to “2. Calibration” Press “Set” to enter calibration section. Select “1. Calibration check” by pressing “Set”

fig 24

If a pot is not sitting on the logger, the display will indicate “Replace Pot” indicating to the user to place the pot on the logger. “Wait” will now be displayed whilst the logger is autozeroed. At the end of the autozero sequence, “Remove pot” will be displayed. Removal of the pot will automatically be detected and “wait” will be displayed for a short while followed by “Place weight on logger”. After placing the weight on the logger the unit will display “calibrating”, check the calibration and the result is printed out on the printer. The Calibration check is now complete and the brass calibration weight should be removed and stored in a safe place. If the unit fails the calibration check, refer to technical support for recalibration. (See page 20) It is recommended that the weight is checked annually for accuracy. Store the weight carefully. Check for damage before use.

Previous Calibration Dates See page 10, menu section 3 for instructions on how to recall previous calibration dates. Page 15 of 24

Portaflow™ User’s Guide

Charging the Battery Do not use the equipment whilst charging. To charge the battery in the display panel with the display panel mounted on the stand, remove the pot and connect the dc plug into the socket as shown in fig 25. Connect the charger to the mains and switch on. The display will indicate alternatively ‘Charging/Not in use’. To charge the battery of the display panel separately from the urinal, first remove the plug from the back panel that connects to the logger (fig 26). Remove by holding only the grey collar of the plug and pull gently. Connect the dc plug into the socket as shown in fig 25. Connect the charger to the mains and switch on.

fig 25

The LCD display will indicate alternatively ‘Charging/Not in use’. The charger incorporates a fast charge to allow the battery to be fast charged in approximately five hours. ‘Charging / Not in use’ will be constantly indicated whist charging in the fast charge mode. When the battery is almost fully charged the display will show ‘Charging complete’ and go into trickle charge mode. Although the battery can be used as soon as the ‘Charging complete’ is indicated, leaving the battery fig 26 pack on charge for at least a further hour will allow the battery to trickle charge to maximum charge.
Use only the charger provided (Mediwatch part number PA00116) with the Portaflow™. When the battery is almost empty, a low-battery indication will appear on the screen. The battery will operate for a further 10 minutes.

Caution • Do not open or throw batteries in the fire, heat or short circuit. Dispose of carefully. • Ensure the equipment is operated within a temperature range of 0 to 40ºC. Page 16 of 24

Portaflow™ User’s Guide

General Equipment Cleaning NOTE: Always follow these basic precautions for cleaning and high level disinfection. • DO NOT soak the plastic in alcohol. Alcohol is inactive against certain organisms.

DO NOT rub the plastic with an abrasive sponge. When washing with soap and water use a soft cloth or towel and gently hand wipe the plastic. (fig 27) •

fig 27

If the plastic is heavily soiled: • Hand wash with water and mild detergent. • Wipe the plastic dry with a towel. Disinfect the plastic using Mediwipes, Azowipes, T-Spray or an alcohol • based spray e.g. Azospray. If the plastic is lightly soiled: • Clean and disinfect the plastic using a cloth damped with 70% or less, alcohol solution. The following procedures are known to damage plastics: Autoclaving Soaking the plastic in chlorine bleach NOTE: High-level disinfect plastics ONLY by soaking in the recommend liquid germicide. Other methods are NOT allowed. These could damage the plastics. • • •

Cleaning of the Logger Use the methods outlined above but do not turn the Logger upside down to clean. Cleaning fluids may enter inside the case and cause damage.
The logger is not suitable for Autoclaving. Cleaning and Inspection of the Charger Periodically check the charger case and cable for damage do not use any damage is found. Clean and disinfect the case and lead using a cloth damped with 70% or less, alcohol solution.

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Portaflow™ User’s Guide Handling and Care Although the Portaflow™ is produced with the utmost care and only the highest quality components are used, maintenance will be necessary from time to time to ensure trouble-free operation. A contract for yearly service can be made with your local representative.  Remove loose dust from the exterior casing with a soft cloth or a dry brush.  A solution of water with a mild detergent may be used. Avoid abrasive cleaners. Warnings and Precautions Always follow these basic precautions:  Inspect the plastic daily for cracks and other damage.  DO NOT use a plastic that has been cracked or damaged, in particular, the mains power supplies.  DO NOT use a probe that has been dropped or struck against another object until it is inspected by a service engineer.  Avoid pinching or kinking the probe cable. If the probe housing becomes cracked or broken or if there are cuts or openings in the probe cable the electric safety of the probe could be compromised.  Switch the system off before cleaning and disinfection.

Safety and Performance Summary Ensure that the urinal will be motionless during readings by locking the castors and warning the patient not to shake the stand whilst voiding. Patients who are unstable on their feet should use a toilet chair in preference to the urinal. The most accurate measurements are obtained when the patient is not resting on the stand. Spares List Part Number EA0041 PA00144 E0107 PA00141 PA00116 E1004 E1005

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Description Logger Jug Printer Paper Calibration Weight Display Panel Rechargeable Battery Display Panel Charger Wall bracket Desk stand

Portaflow™ User’s Guide

Warnings and Precautions To avoid the risk of explosion the equipment must not be operated in the presence of flammable anaesthetics •

To avoid the risk of shock do not open the equipment. Refer servicing to qualified personnel only. •

Be careful not to place the patient in contact with the equipment or other devices. If the equipment or associated parts are defective, there is a risk of electrical shock.

•

The use of non-Mediwatch components with this equipment may result in damage to Mediwatch components. (e.g. Mediwatch power supply for charging) •

•

Do not subject the equipment to excessive shock

The manufacturer, assembler, installer or importer considers himself responsible for the effects on safety, reliability and performance of this product only if: - Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorised by him. - The electrical installation of the relevant room complies with IEC requirements. - The product is used in accordance with the instructions for use. Do not use the equipment in locations subject to intense electric or magnetic fields

•

Do not use the equipment near devices generating high frequencies. If used near such devices, the equipment may malfunction or adversely affect the device. •

To guarantee proper unit operation, do not operate the equipment in an environment with a temperature in excess 0-40 °C. If the equipment is used in a small area the temperature may rise. Proper ventilation must be provided. •

•

Avoid installation near a heater or in direct sunlight.

Inspect the plastic cases carefully after a fall. A dangerous situation may arise due to damaged insulation. •

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Portaflow™ User’s Guide

Trouble Shooting Due the simplicity of design there is little to cause problems. However, by regularly checking that the cables are connected correctly, particularly after charging, and keeping the battery in good condition and by regularly charging and storing in a charged condition there is little to cause problems. Battery appears dead Most equipment problems are due to a discharged battery and can be fixed by Charging. Check the battery indicator on the display panel. If low battery is indicated, re-charge the battery. Bleeping noise from the display panel A bleeping noise from the Display Panel signifies a low battery condition and should be recharged at the first available moment. No printout Check the red “status” indicator on the left of the printer. If the indicator is flashing, check and if necessary, replace or re-feed the paper. No Pot continuously indicated Check the cable is connected between the display panel and the logger. First check the plug with the yellow collar is connected and pushed home into the rear of the Display Panel. This must be re-connected after charging. Secondly check the plug with the red collar is connected and pushed home into the rear of the logger. Printer paper has a ruffled edge Flip the printer cover down and pull forward the top part of the green lever (fig 20) to release the roller. Pull forward the paper until it stops ruffling the paper edge and push back the green lever. Close the printer cover.

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Portaflow™ User’s Guide Avoiding, Identifying and Resolving Adverse Electromagnetic Effects There are no restrictions for the use of the Portaflow™ urological device due to it electromagnetic characteristics. Both the emissions from the Portaflow™ urological device, and the susceptibility of the Portaflow™ urological device to interference from other sources, are within prescribed limits of all applicable standards at the date of manufacture. The emissions test procedure used is that specified in EN55011: 1991 for Group 1, Class B equipment (per EN60601-1-2, 26.201.1.7). The Portaflow™ urological device is suitable for use in ISM (industrial, scientific and medical) environments, and in domestic environments under the jurisdiction of a health care professional. An indication of adverse electromagnetic effects from the Portaflow™ urological device on another electronic devise would be a degradation of performance in that other device when the Portaflow™ urological device is operated simultaneously. If such interference is suspected, separate the two devices as much as possible, or discontinue simultaneous operation, if practical, and contact Mediwatch (UK) Ltd. The Portaflow™ urological device will operate normally in the proximity of other potential interference sources, and has demonstrated immunity at a field strength of 3 V/m (per EN60601-1-2, 36.202.2.1.). No other precautions need be taken as regards exposure in reasonably foreseeable environmental conditions to magnetic fields, pressure or variations in pressure, acceleration, or thermal ignition sources.

Technical Support and Extended Maintenance For Technical advice on maintenance and calibration, contact: (or your local technical department) Technical Support Department Mediwatch (UK) Limited Swift House Cosford lane Rugby Warwickshire CV21 1QN

Tel: +44 (0) 1788 547 888 Fax: +44 (0) 1788 536 434

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