Flowstar User and Service Manual Ver 13.00 June 2020

LABORIE International 6415 Northwest Drive, Unit 11 Mississauga, ON, Canada L4V 1X1 Tel.: +1 905 612 1170 Fax: +1 905 612 9731 Email: [email protected] LABORIE USA 400 Avenue D, Suite 10 Williston, Vermont, 05495 Tel.: 1 800 522 6743 Fax: 1 802 878 1122 Email: [email protected] LABORIE Europe P.O. Box 580 7500 AN Enschede The Netherlands Tel.: +31 53 480 3700 Fax: +31 53 480 3701 Email: [email protected] Medical Measurement Systems B.V. Colosseum 25 7521 PV Enschede Netherlands www.laborie.com LABORIE Document Code: 0075-MAN-022-EN-V13.00 Flowstar Users & Service Manual Date of Release: June 23, 2020 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 ... 13 1.5 Warranty ... 13 1.6 Block Diagram ... 14 1.7 About This Manual ... 14

2.

Installation ... 17 2.1 System Overview ... 17 2.2 Flowmeter ... 18 2.2.1 2.2.2

2.3 2.4

Introduction ... 18 Flowmeter ... 19

Power Supply ... 21 Insert New Paper ... 23

3.

Control the Equipment ... 25 3.1 Flowstar Keyboard ... 25 3.2 Manual or Automatic Operation ... 27

4.

Investigation ... 29 4.1 Automatic Operation ... 29 4.2 Manual Operation ... 30 4.3 Print Report ... 31 4.3.1 4.3.2 4.3.3 4.3.4

Flow and voided volume curves ... 31 Patient information ... 32 Results ... 33 Siroky plot ... 35

5.

Maintenance ... 37 5.1 General ... 37 5.2 Cleaning the System ... 37 5.3 Preventive Maintenance ... 39 5.4 Testing the System ... 39

6.

Settings ... 43 6.1 Overview ... 43 6.2 Keyboard Settings ... 44 3

6.2.1 6.2.2 6.2.3

6.3

Settings Menu ... 45 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 ... 44 Volume scale ... 44 Siroky plot printout ... 44 Pre-flow time ... 45 Post-flow time ... 45 Language ... 45 Operation mode ... 46 Volume graph on printout... 46 Flow graph only ... 46 Uroflow report print orientation ... 46 Real-time graph printout ... 46 Reprint graph printout ... 47 Detect artefacts ... 47

Technical Specifications ... 49 7.1 Flowstar ... 49 7.2 Flowmeter ... 49 7.3 Thermal paper ... 50 7.4 Environmental conditions ... 50

Warranty

53

Appendix A Configuration and Accessories ... 55 Appendix B Explanation of Symbols ... 57 Appendix C Electro Magnetic Compatibility ... 61

Safety Information

© 2000-2020 by MMS b.v.

4

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 must 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 requirements as stated by IEC 60601-1:2005 + CORR. 1:2006 + CORR.2:2007 + A1:2012, IEC 60601-1-2:2014, MDD, Medical Device Directive 93/42/EEC, Class IIa medical device, ANSI/AAMI ES60601-1:2005 + C1:2009 + A1:2012 + A2:2012, CAN/CSA-C22.2 No. 60601-1:2014, SGS contract no. 710253. The Flowstar measurement system only complies to the above requirements, when it is used with specified and approved LABORIE 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 5

CAUTION

NOTE

reactions associated with the use or misuse of the device. 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. The note sign appears when it is important to read the information.

All repairs, which are not performed by LABORIE personnel are for the responsibility of the hospital. LABORIE 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 LABORIE qualified personnel. General WARNING

No modification of this equipment is allowed.

CAUTION

Do not to position the Flowstar system so that it is difficult to access the plug from the wall socket.

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 WARNING

Connect only LABORIE 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.

Safety Information

© 2000-2020 by MMS B.V.

6

WARNING

Make sure the Flowstar is connected to the correct power supply (PS-FLOWSTAR) 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.

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

© 2000-2020 by MMS B.V.

7

Cleaning CAUTION

To prevent damage of the Flowstar measurement system do not use thinner or similar solvents.

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. Abnormal environmental conditions include, but are not limited to: Safety Information

© 2000-2020 by MMS B.V.

8

 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.

© 2000-2020 by MMS B.V.

9

Safety Information

© 2000-2020 by MMS B.V.

10

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. There is one model of the Flowstar system (LABORIE systems catalogue U21). The complete system consists of the following equipment:  Flowstar.  Flowmeter.  AC adapter/power supply (PS-FLOWSTAR).

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 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. 11

1.2

Intended Use

The Flowstar is intended for uroflow measurements. The Flowstar is intended to assist physicians in executing urodynamic studies, collecting data and printing test results. The Flowstar is intended to be used in a professional healthcare facility. In its daily use, a clinician and/or a physician are the main users of the Flowstar. Examples of clinician and/or physicians are:  Urologists  Pediatricians  Uro-gynecologists  Gynecologists  Nursing homes  General practitioners Intended patient population:  Male & female children and adults  Patients with lower urinary tract voiding problems  Incontinence patients  Patients with bladder outlet obstructions  Patients with neurogenic bladder dysfunction  Some children with complex voiding / incontinence problems The Flowstar device has no known contraindications.

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.

Introduction

© 2000-2020 by MMS B.V.

12

1.4

Repair

All repairs, which are not performed by LABORIE personnel are for the responsibility of the hospital. LABORIE 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 LABORIE qualified personnel. Before sending the equipment for repair please contact your LABORIE representative. Note that all equipment needs to be properly cleaned before shipment. The Flowstar and flowsensor should be cleaned with alcohol.

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 must ship the flow sensor for repair in the special flow sensor box as supplied with your system. Warranty stops when the flow sensor is transported in a different box. When your flow sensor box is damaged, please contact your LABORIE 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

Introduction

© 2000-2020 by MMS B.V.

13

1.6

Block Diagram

Below you can find the schematic representation of the Flowstar system.

Figure 1.3 Block Diagram Flowstar

1.7

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 must 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.  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.

Introduction

© 2000-2020 by MMS B.V.

14

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 LABORIE welcomes your opinion and ideas to improve our manuals. Please send your questions and remarks to our Training & Education department:

[email protected]

Introduction

© 2000-2020 by MMS B.V.

15

Introduction

© 2000-2020 by MMS B.V.

16

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.

17

2.2

Flowmeter

2.2.1

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

Installation

© 2000-2020 by MMS B.V.

18

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

© 2000-2020 by MMS B.V.

19

 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

Installation

© 2000-2020 by MMS B.V.

20