Flowstar Users and Service Manual Sept 2013

MMS (head office) P.O. box 580 7500 AN Enschede The Netherlands Phone : +31 – 53 480 37 00 Fax : +31 – 53 480 37 01 E-mail : [email protected] Internet : www.mmsinternational.com MMS Deutschland GmbH Postfach 10 10 27 D-46210 Bottrop Deutschland Tel : 0 20 41 – 55 80 10 Fax : 0 20 41 – 55 80 11 E-mail : [email protected] Internet : www.mms-deutschland.de MMS USA, Inc. 53 Washington Street, Suite 400 Dover, NH 03820 USA Phone : 800 – 236-9310 Phone : 603 – 750-0037 Fax : 603 – 750-3155 Email : [email protected] Internet : www.mmsusa.net MMS documentcode: 0075-MAN-022-05V00E Flowstar User’s & Service Manual Date of release: 10 September 2013 MMS is a registered trademark of Medical Measurement Systems B.V., Enschede, the Netherlands

Table of contents Safety information ... 5 1.

Introduction... 11 1.1 Flowstar ... 11 1.2 Intended use ... 12 1.3 Safety information ... 12 1.4 Repair ... 12 1.5 Warranty ... 13 1.6 About this manual ... 13

2.

Installation... 15 2.1 System overview... 15 2.2 Flowmeter ... 16 2.2.1 2.2.2

2.3 2.4

Introduction ... 16 Flowmeter ... 17

Power supply ... 19 Insert new paper ... 21

3.

Control the equipment ... 23 3.1 Flowstar keyboard... 23 3.2 Manual or automatic operation ... 25

4.

Investigation... 27 4.1 Automatic operation ... 27 4.2 Manual operation ... 28 4.3 Print report ... 29 4.3.1 4.3.2 4.3.3 4.3.4

5.

Flow and voided volume curves... 29 Patient information... 30 Results... 31 Siroky plot ... 33

Maintenance ... 35 5.1 General ... 35 5.2 Cleaning the system ... 35 5.3 Preventive maintenance ... 37 5.4 Testing the system... 37

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6.

Settings... 41 6.1 Overview ... 41 6.2 Keyboard settings ... 42 6.2.1 6.2.2 6.2.3

6.3

Settings menu ... 43 6.3.1 6.3.2 6.3.3 6.3.4 6.3.5 6.3.6 6.3.7 6.3.8 6.3.9 6.3.10

7.

Flow scale... 42 Volume scale ... 42 Siroky plot printout ... 42 Pre-flow time... 43 Post-flow time ... 43 Language... 43 Operation mode ... 44 Volume graph on printout... 44 Flow graph only ... 44 Uroflow report print orientation... 44 Real-time graph printout ... 44 Reprint graph printout ... 45 Detect artefacts... 45

Technical Specifications... 47 7.1 Flowstar ... 47 7.2 Flowmeter ... 47 7.3 Thermal paper... 48

APPENDICI AND WARRANTY ... 49 Warranty

... 51

Appendix A Configuration and accessories ... 53 Appendix B Explanation of symbols... 55 Appendix C Electro Magnetic Compatibility ... 57 Appendix D CE certificate/Declaration of conformity ... 63

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© 2000-2013 by MMS b.v.

Safety information The Safety information in this manual is intended for:  users performing investigations by using the Flowstar system.  users who install, test and maintain the Flowstar system. Before working with the Flowstar measurement system and this manual, you have to know the safety information as described below. The Flowstar is a prescription device to be used only by physicians or individuals who have been trained and authorized by a physician or by a medical institution, under the supervision of a physician. The Flowstar must be purchased under the supervision of a physician. For US only: Caution: Federal law restricts this device to sale by or on the order of a physician. The Flowstar measurement system complies with the requirement as stated by IEC60601-1 3rd edition (Medical Electrical Equipment), ANSI:AAMI ES606011:2005, CAN/CSA C22.2 NO. 60601-1:08, IEC 60601-1-2 (EMC) and the Medical Device Directive (93/42/EEC). The Flowstar measurement system only complies to the above mentioned requirements when it is used with specified and approved MMS modules/devices as mentioned in this document. The instructions, precautions and warnings in this manual should be followed by the operator to ensure safe operation and to maintain the Flowstar in a safe condition. Therefore the use of the Flowstar should be restricted to qualified personnel only. The following signs are printed in this manual in front of important warnings, precautions and notes. It is important to pay good attention to these warnings and precautions to provide patient safety and to prevent damaging of the equipment. WARNING A warning is a statement that alerts the user to the possibility of injury, death or other serious adverse reactions associated with the use or misuse of the device. © 2000-2013 by MMS b.v.

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CAUTION

A caution is a statement that alerts the user to the possibility of a problem with the device associated with its use or misuse. Such malfunctions include device malfunction, device failure, damage to the device or damage to other property.

NOTE

The note sign appears when it is important to read the information.

The Flowstar can only be used indoor at temperatures between between +15EC and +35EC (+59EF to +95EF) and at a humidity between 45% and 75%, non-condensing. The Flowstar must be used or stored in a dust-free environment. All repairs, which are not performed MMS personnel are for the responsibility of the hospital. MMS will not give any guarantee or take any responsibility for any part, which has been opened, adjusted or replaced by hospital personnel. The Flowstar may only be opened for any adjustment, replacement, maintenance or repair by MMS qualified personnel. Unpacking CAUTION

See the packing list to check if all items are present.

CAUTION

Please be careful while unpacking the Flowstar measurement system. The Flowstar consists of delicate equipment.

Installation

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WARNING

Connect only MMS devices to the Flowstar.

WARNING

Safety can be violated if the Flowstar or one of its modules shows visible damage.

WARNING

Do not attempt to open Flowstar modules.

WARNING

Make sure the Flowstar is connected to the correct power supply before switching on.

© 2000-2013 by MMS b.v.

Safety information

WARNING

Do not use a power supply other than which is specified. Doing so may cause fire leading to serious accidents.

WARNING

Do not bend the power cable forcibly, or place a heavy object on the cable because it might damage the cable and cause fire or electric shock. If the power cable is damaged, discontinue use and replace it immediately.

WARNING

The digital cable connected to the Flowstar has a connector with locking mechanism. Do not attempt disconnection by pulling the cable. Loosen the lock by pressing the lever on top of the connector.

Flowmeter CAUTION

When pouring water with high speed in the urine container on the flow sensor, for example with a cup, artefact detection does not work so well as during an actual investigation (Flowstar demonstrations only).

CAUTION

Do not drop the flow sensor. Do not apply excessive force on the flow sensor (maximum 3.5 kg) or let things drop on the flow sensor. This can permanently damage the flow sensor.

CAUTION

Avoid touching or kicking the flow sensor during an investigation!

CAUTION

Do not try to remove the flow sensor top-plate by pulling or screwing the top-plate.

CAUTION

Do not use chloride-based solutions for cleaning the flow stand. Check that the solution does not affect stainless steel (AISI304L). Clean the flow stand if it was contaminated with urine.

Safety information

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Cleaning CAUTION

Never use any detergents, thinner, benzine or other volatile chemicals while cleaning the Flowstar measurement system to prevent damage to the system.

CAUTION

Do not use excessive amounts of water for cleaning the Flowstar to prevent damage to the system.

CAUTION

Never allow water to get inside the Flowstar or any other part to prevent damage to the system.

Investigation WARNING

Investigation procedures as described in this manual do not pretend to be complete. How an investigation is performed and how the results are interpreted, the actual diagnosing, remains under all circumstances the responsibility of the clinician/physician performing the investigation. The description of investigation proceedings is only included to serve as an example to discuss the use of the various markers and the various transducers to reduce risks involving wrong treatment of a patient.

WARNING

Do not allow metal or liquids to touch the internal parts or slot of the printer. Doing so may cause fire, electric shock, or other accidents.

WARNING

Safety can be violated if, for example, the apparatus:  shows visible damage.  fails to perform the intended measurement.  has been subjected to prolonged storage under unfavourable conditions.  has been subjected to severe stresses in transit.  has been handled by unqualified personnel.

Although precautions have been taken in this apparatus to prevent malfunctions due to abnormal environmental conditions and/or abnormal handling, such malfunctions can occur in some circumstances. 8

© 2000-2013 by MMS b.v.

Safety information

Abnormal environmental conditions include, but are not limited to:  any other condition as is specified in the manual.  (electro-)magnetic fields caused by portable equipment (telephones, computers, etcetera), X-ray equipment, (radio-)transmitters, radarequipment, etcetera.  Electro Static Discharge.  mains disturbances.  extreme temperatures, pressures, humidity, dust, etcetera. Abnormal handling includes, but is not limited to:  any handling other than specified in the manual.  rough handling.  handling by unqualified staff. Providing such or similar conditions do not occur, this apparatus will prove to be durable and reliable. NOTE

Safety information

Check the functionality of the Flowstar system regularly.

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© 2000-2013 by MMS b.v.

Safety information

1. 1.1

Introduction

Flowstar

The Flowstar is a stand-alone system, developed by Medical Measurement Systems (MMS), to perform uroflow investigations in hospitals and clinics. The complete system consists of the following equipment:  Flowstar.  Flowmeter.  AC adapter/power supply.

Figure 1.1 Flowstar

The Flowstar is supplied with a built-in printer and is connected to the flowmeter. The flow sensor measures flow and volume. The investigation starts automatically when a flow is detected. Flow and miction volume are printed real-time, so the results are immediately available after the investigation. The Flowstar contains software for user control, for reading data from the flow sensor, for calculating the results and for printing the curves and results on

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paper. Thermal paper is needed for the printouts. A keyboard is integrated for the user control. The Flowstar is powered by an external power supply.

1.2

Intended use

The Flowstar system is intended for uroflow measurements. The Flowstar is intended to assist physicians in executing uroflowmetry investigations, analysing collected data and archiving patient and testing information. General indications for use include use in patients with lower urinary tract voiding or incontinence problems, and more specifically incontinence patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction and some children with complex voiding / incontinence problems.

1.3

Safety information

The Flowstar User’s & Service Manual is intended for all users of the Flowstar measurement system. Before working with the system and its manual, please take notice of the safety information as described at the beginning of this manual.

1.4

Repair

All repairs, which are not performed by MMS personnel are for the responsibility of the hospital. MMS will not give any guarantee or take any responsibility on a part, which has been opened, adjusted or replaced by hospital personnel. The Flowstar may only be opened for any adjustment, replacement, maintenance or repair by MMS qualified personnel. Before sending MMS equipment for repair please contact your MMS representative. Note that all equipment needs to be properly cleaned before shipment. The Flowstar and flowsensor should be cleaned with alcohol.

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© 2000-2013 by MMS b.v.

Chapter 1

1.5

Warranty

At the end of this manual you will find warranty information. Additional warranty information is described below. In case of a flow sensor malfunction, the customer has to ship the flow sensor for repair in the special MMS flow sensor box as supplied with your system. Warranty stops when the flow sensor is transported in a different box. When your MMS flow sensor box is damaged, please contact your MMS representative to send you a new box. Note that all used equipment needs to be properly cleaned with alcohol before shipment.

Figure 1.2 Flow sensor box

1.6

About this manual

This manual is intended for users who perform investigations with the Flowstar and can be used as a reference. The technical department can find instructions and technical specifications for service. First-time users always have to read the Safety precautions carefully before starting to work with the Flowstar. The following information is important to install, control and configure the Flowstar:  Chapter 2 ‘Installation’ describes how the Flowstar is installed.  Chapter 3 ‘Control the equipment’ describes the keyboard function keys.

Introduction

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 Chapter 6 ‘Settings’ describes how to set user settings as flow scale, volume scale, print orientation of the results, language, etcetera. To perform an investigation, read chapter 4:  Chapter 4 ‘Investigation’ describes how a uroflow investigation is done and which results are calculated. For service the following chapters are important:  Chapter 5 ‘Maintenance’ describes how to clean the system and to perform preventive maintenance.  Chapter 7 ‘Technical specifications’ describes the technical specifications of the different parts of the Flowstar. Feedback on the manual MMS welcomes your opinion and ideas to improve our manuals. Please send your questions and remarks to our Training & Education department:

[email protected]

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© 2000-2013 by MMS b.v.

Chapter 1

2. 2.1

Installation

System overview

The Flowstar contains a keyboard and a printer. On the left side you will find an 1..0 Power on/off switch (when you look from the front).

Figure 2.1 Flowstar back side

The figure above shows the back side of the Flowstar. You can see a connection for the flowmeter and the power supply.

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2.2 2.2.1

Flowmeter Introduction

With a flowmeter you can measure the voided volume and the flow during a uroflow study. The flowmeter is described in § 2.2.2. CAUTION

Do not drop or throw the flow sensor. Do not apply excessive force on the flow sensor (maximum 3.5 kg) or let things drop on the flow sensor. This can permanently damage the flow sensor.

CAUTION

Avoid touching or kicking the flow sensor during an investigation.

CAUTION

Do not try to remove the flow sensor top-plate by pulling or screwing the top-plate.

Flexible cable length The flow sensor has a standard cable length of 4 metres (13 ft). Optionally, this can be 10 metres (33 ft). The long cable enables installation of a flow sensor in another room, for example the toilet.

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© 2000-2013 by MMS b.v.

Chapter 2

2.2.2

Flowmeter

The Flowmeter is supplied with flow sensor, flow stand, funnel and urine container as displayed below.

Figure 2.2 Flowmeter

1 2 3 4

Flow sensor Connector for digital cable to Flowstar Flow sensor status LED Urine container

5 6 7 8 9

Funnel Flow stand pole Vertical position lock-knob Flow stand holder Flow stand foot

Install the flowmeter as follows:  Fasten the flow stand pole [6] on the flow stand foot [9] with the plastic protection and the M6 x 65 mm screw.  Slide the flow stand holder [8] over the flow stand pole [6].  Fasten the flow stand holder [8] at the desired height with the vertical position lock-knob [7]. Note: lift the flow stand holder a little when you want to change the height of the flow stand holder.  Place the flow sensor [1] on the flow stand holder [8] while the connector is positioned at the rear (see drawing). The flow sensor can be fixed on the flow stand holder with a M4 x 16 mm screw.  Place the urine container [4] onto the flow sensor [1]. Installation

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 Put the flow funnel [5] into the cup of chalice at the top of the stand.  Connect the digital cable to the flow sensor [2].  Connect the other end of the cable to the Weighing scale connector at the back of the Flowstar. Pick-up the flow stand The best way to pick-up the flow stand is to take the flow stand arm on which the funnel is placed. Be careful when the flow sensor is not secured on the flow stand.

Figure 2.3 Pick-up Flowmeter

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© 2000-2013 by MMS b.v.

Chapter 2

2.3

Power supply

The Flowstar needs an external power supply as supplied by MMS.

Figure 2.4 Flowstar power supply

WARNING

Make sure the Flowstar is connected to the correct power supply before switching on.

WARNING

Do not use a power supply other than which is specified. Doing so may cause fire leading to serious accidents.

WARNING

Do not bend the power cable forcibly, or place a heavy object on the cable because it might damage the cable and cause fire or electric shock. If the power cable is damaged, discontinue use and replace it immediately.

Installation

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To connect the power supply:  Turn off the power with the I..0 Power switch.  Plug-in the DC plug into the power supply jack on the Flowstar.  Plug the AC adapter into an outlet.  Turn on the power with the I..0 Power switch. The green Power lamp on the left front side is on. The Flow, Volume and Siroky LEDs are also on. The Flowstar is ready for operation. To remove the power supply:  Turn off the power with the I..0 Power switch.  Unplug the AC adapter and the DC plug. The polarity of the power supply is as displayed in the figure below.

Figure 2.5 Polarity

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Chapter 2