D.med NephroFlow Operating Instructions Ver 4.0

Table of Contents 1

2

3

4

5

Intended use ... 5 1.1

Indication for Use ... 5

1.2

Contraindication for Use ... 5

Safety and Important information ... 5 2.1

General Safety Information ... 5

2.2

General Important Information... 8

Symbols and Abbreviations ... 8 3.1

Symbols used in this Operating Instructions ... 8

3.2

Symbols on External Power Supply Unit ... 8

3.3

Symbols on Device, Sensors and on Packaging ... 9

3.4

Abbreviations ... 10

Description of System and Components ... 11 4.1

Front and Rear View ... 11

4.2

VESA Fixing ... 12

4.3

Ultrasonic Dilution Sensor ... 13

4.4

Power Supply ... 13

4.5

Connection of Peripheral Devices ... 14

4.6

USB Connection Restriction... 14

Theory of Measurement... 15 5.1

Access Flow Measurement ... 15

5.2

Recirculation Measurement ... 16

6

Installation – Preparing for Measurement ... 16

7

Description of Main Menu Functions Including Operation Modes ... 17

8

7.1

Operation Mode ... 17

7.2

Patient Database ... 17

7.3

System Settings ... 17

7.4

Printer Settings ... 18

7.5

Printer Installation ... 18

7.6

Update Tubing Database ... 18

7.7

Manufacturer Information ... 18

7.8

Service ... 18

Patient Database ... 19

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8.1 9

Detailed Information for “Patient Report”... 20

Performing a Measurement ... 21 9.1

Access Flow... 21

9.2

Recirculation ... 22

9.3

Offset Correction ... 23

9.4

Description of Screen Elements ... 23

9.4.1

Patient – Select ... 23

9.4.2

Patient – Report ... 24

9.4.3

Protocol – Access Flow/ Recirculation ... 24

9.4.4

Tubing – Select ... 24

9.4.5

Blood Lines Position Window ... 24

9.4.6

Recirculation ... 24

9.4.7

Access Flow... 24

9.4.8

Signal Strength... 24

9.4.9

Blood Flow ... 25

9.4.10

Status ... 25

9.4.11

Instruction to Start a Measurement ... 25

9.4.12

Result Window ... 25

9.4.13

Measurement – New ... 26

9.4.14

Measurement – Print ... 26

9.4.15

Measurement – Export... 26

10 Description of Errors ... 26 11 Cleaning and Disinfection of System ... 27 11.1

Cleaning and Disinfection of the D.med NephroFlow™ ... 27

11.2

Cleaning and Disinfection of the UDS... 27

12 Periodic Safety and Accuracy Checks ... 29 13 Technical Specification ... 33 13.1

Operating Storage and Transport Conditions ... 34

14 List of Parts and Accessories ... 34 15 Guidance and Manufacturer’s Declaration for Electromagnetic Compatibility ... 35 16 Contact Data ... 40 16.1

Distributor ... 40

16.2

Technical Service ... 40

16.3

Manufacturer ... 40

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List of Figures Figure 1: Front and Rear View ... 11 Figure 2: VESA mounting plate ... 12 Figure 3: Components UDS ... 13 Figure 4: Power Supply Housing ... 13 Figure 5: Theory of access flow measurement ... 15 Figure 6: Theory of Recirculation measurement ... 16 Figure 7: Main menu ... 17 Figure 8: Patient Report ... 20 Figure 9: Recirculation ... 24 Figure 10: Access Flow ... 24 List of Tables Table 1: General Safety Information ... 7 Table 2: General important information ... 8 Table 3: Symbols used in these Operating Instructions ... 8 Table 4: Symbols on External Power Supply ... 9 Table 5: Symbols on Device, Sensors and Packaging ... 10 Table 6: Abbreviations... 11 Table 7: Components Front View ... 11 Table 8: Components Rear View ... 12 Table 9: Components UDS ... 13 Table 10: Components Power Supply ... 14 Table 11: Peripheral Devices ... 14 Table 12: System settings ... 17 Table 13: Patient Database ... 19 Table 14: Access Flow Measurement ... 22 Table 15: Recirculation measurement ... 23 Table 16: Errors ... 26 Table 17: Recommended surface disinfectants for D.med NephroFlow™ ... 27 Table 18: Recommended surface disinfectants for UDS ... 28 Table 19: Technical Specification ... 33 Table 20: Operating, storage and transport conditions ... 34 Table 21: List of parts and accessories ... 34 Table 22: Guidance and manufacturer´s declaration - Electromagnetic emissions... 35 Table 23: Guidance and manufacturer´s declaration - Electromagnetic immunity ... 36 Table 24: Guidance and manufacturer´s declaration - Electromagnetic immunity ... 37 Table 25: Recommended separation distances ... 38

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Read these Operating Instructions carefully before the first use!

1 Intended use

If this device is not used as intended, the patient and user may be exposed to risks that were not taken into account during development.

1.1

Indication for Use

D.med NephroFlow™ with the Ultrasonic Dilution Sensor is a System to be used in dialysis centers or in nephrology departments of hospitals to measure: a) the Access Flow (Shunt Flow); and/ or b) the Recirculation in the shunt of patients during hemodialysis.

1.2

Contraindication for Use

The device is exclusively designed for the described intended use. Not suited for patients undergoing single needle dialysis. Not suited for patients undergoing peritoneal dialysis.

2 Safety and Important information 2.1

General Safety Information Warning! The general safety information below must be observed without fail to ensure safe handling of the device:

The device must be operated by qualified medical personnel only. The measured values serve exclusively to check the flow rate through blood vessels. The curves, values or parameters cannot be used as the only indicator to assess the patient's clinical state or to replace patient monitoring. Medical actions without consulting the results from other medical measurement procedures (e.g. creatinine clearance values, ultrasonic imaging, angiographic means) shall not be performed. The use of clinical procedures and techniques is the sole responsibility of the physician. D.med NephroFlow Clinical Manual-en

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It is the responsibility of the operator of the device to ensure it is used, inspected and maintained in accordance with the Operating Instructions. Subsequent revisions or instructions from the manufacturer must also be taken into account in this regard. Type of danger

Safety information

Risk of explosion, Risk of fire

The D.med NephroFlow™ and accessories are not intended for use in an explosive atmosphere, with flammable anesthetics, in conjunction with flammable agents or in an oxygen rich environment.

Risk to electrical safety, or of increased electromagnetic emissions or lower resistance of device to interference

Use of accessories, power supply units, cables (lines) and converters (sensors, transducers) other than those specified in these Operating Instructions is not permitted. See chapter entitled 15 Guidance and Manufacturer’s Declaration for Electromagnetic Compatibility. See chapter entitled 6 Installation – Preparing for Measurement.

Risk to safety due to defective or damaged device, applied part or accessory

A defective or damaged device, applied part or accessory must not be used and must be replaced immediately. This applies in particular if the cable insulation is damaged or if parts have broken off or are bent.

Electric shock

The D.med NephroFlow™ and its power supply unit may only be used in a dry environment. However, in the event of the ingress of liquid, unplug the power cord immediately. Stop using the device and send it to our Service department (see 16 Contact Data) for inspection.

No fast disconnect from mains

The power supply must be set up in such a way as to ensure ease of access to the plug in the wall socket or to the mains plug at the power supply to enable the power supply to be disconnected quickly from the mains. Only connect dry sensors. The connecting plug must only be plugged in when dry.

Risk of electrical defect Malfunctions, inaccurate measured value due to highfrequency devices

The D.med NephroFlow™ may be influenced by RF devices. This includes mobile RF communication equipment. See chapter entitled 15 Guidance and Manufacturer’s Declaration for Electromagnetic Compatibility.

Electromagnetic incompatibility of devices

The device must not be used adjacent to or stacked with other equipment, if adjacent or stacked use is necessary, the device should be observed to verify normal operation in the configuration in which it will be used. See chapter entitled 15 Guidance and Manufacturer’s Declaration for Electromagnetic Compatibility.

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Type of danger

Safety information

The device may malfunction, be damaged beyond repair or cause injury if it falls down Overheating of the device Overheating of the power supply Incorrect repairs

Make sure the device is placed on a stable supporting surface.

Measuring inaccuracy, Risk to electrical safety Infection due to improper cleaning, disinfection

Incorrect electrical installation Risk of infection/environmental contamination due to improper disposal

Refer to the chapter entitled 4.2 VESA Fixing when mounting the device on a bracket

Always prevent the ventilation slots from being covered or sealed up. Prevent the power supply from being covered. Repairs to the device may only be carried out by authorized em-tec GmbH service personnel. Refer to service manual. The measuring accuracy and safety-relevant aspects must be checked at least every 2 years. Refer to service manual. Only clean and disinfect the device and accessories using the equipment and methods recommended by the manufacturer. Also observe the statutory regulations that apply in your country as well as the hygiene regulations in force at the medical practice or hospital. Follow the instructions in the chapter entitled 11 Cleaning and Disinfection of System. Comply with the installation requirements; refer to the chapter entitled 4.5 Connection of Peripheral Devices. The device and accessories must be disposed of in accordance with the national specifications for waste electrical and electronic devices. Make sure that all components are cleaned and disinfected prior to disposal.

Table 1: General Safety Information

The manufacturer only considers itself to be responsible for the safety, reliability and usability of the device if:  the device is used in accordance with the clinical manual.  the electrical installation in the relevant medical locations meets the requirements of IEC60364-7-710 or equivalent national standards.  installation, additions, readjustments, changes or repairs and maintenance are only carried out by persons who have been authorized and trained to do so by the manufacturer. The manufacturer provides no warranty and assumes no liability in the event of non-compliance with the above.

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2.2

General Important Information Caution! Important information regarding correct handling. To be carried out and strictly observed! If this following information is not observed, faults or damage to the product or its surroundings may occur.

NephroFlow is not intended for long term archiving of data. Type of damage

Important information

Loss of data or corrupted data

The device is not designed for electronic long-term archiving of patient data. The operator is responsible for backup and archiving by print out. The manufacturer is not responsible for any loss or damage of data.

Malfunction or irreparable damage

Protect the device from the ingress of moisture, dust or dirt.

Table 2: General important information

3 Symbols and Abbreviations All symbols and abbreviations used are explained in this chapter.

3.1

Symbols used in this Operating Instructions

The following symbols are used in these Operating Instructions to highlight specific information. Symbol

Meaning

Symbol

Warning! This safety symbol precedes critical information that must be strictly observed in order to prevent injuries and fatal hazards.

Meaning Caution! Important information regarding correct handling. Must be performed and strictly observed! If this information is not observed, faults or damage to the product or its surroundings may occur.

Table 3: Symbols used in these Operating Instructions

3.2

Symbols on External Power Supply Unit

Symbol

Meaning

Symbol

Alternating current: Alternating current must be fed to the supplied external power supply unit. The values for the supply voltage must correspond to those of the power supply unit: 100-240 VAC / 50-60 Hz.

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Meaning Friwo Gerätebau GmbH (manufacturer)

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Symbol

IP40

Meaning

Symbol

Protection Class II (protective insulation) As a safety guarantee, this power supply unit has additional insulation to prevent dangerous touch voltage in the event of a fault. A PE conductor must not be connected to this device. Do not dispose of this device as domestic waste! Devices that have been placed on the market on or since 13.08.2005 must be disposed of as waste devices according to Directive 2002/96/EC (WEEE) and national legislation. UL test mark for recognized components for Canada and the USA by Underwriter Laboratories Inc. Protected against access by wire Non-protected against water

Meaning Caution Risk of electric shock. Dry location use only. Fit mains plug before use AC/DC adapter. Further warnings and precautions exist. (Refer to this clinical manual)

CE marking: The external power supply unit satisfies the requirements of Low Voltage Directive 2006/95/EC and EMC Directive 2004/108/EC.

Direct current (12 V DC from external power supply unit)

Table 4: Symbols on External Power Supply

3.3

Symbols on Device, Sensors and on Packaging Symbol

Meaning

Symbol

Follow accompanying documents

IPX4

Meaning Protected against splashing water (Ultrasonic dilution sensor)

(Refer to this clinical manual) CE Marking The device meets with the essential requirements of Directive 93/42/EC (MDD).

Caution! Consult accompanying documents for important safety-related information such as warnings and precautions (Refer to this clinical manual) Direct current (12 V DC from external power supply unit)

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0123

The digit 0123 is the code number of the responsible notified body, TÜV Süd Product Service GmbH, Munich Manufacturer

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Symbol

Meaning

Symbol

Meaning Serial number

Dispose according to Directive 2002/96/EEC Date of manufacture

Catalogue number

USB port

On/Off

Fragile, handle with care

Keep dry

Transport and store this package with this side facing upwards

Number of parts in package

QTY Temperature limit

Air pressure limitation

non-condensing

Humidity limitation, non-condensing

Do not use if package is damaged

Transport

Storage

Table 5: Symbols on Device, Sensors and Packaging

3.4

Abbreviations

Abbreviation

Meaning

AF

Access Flow

BF

Blood flow in dialysis machine

ID

Identifier

KDOQI

Kidney Disease Outcomes Quality Initiative

ml/min

Milliliter Per Minute

l/min

Liter per Minute

REC

Recirculation

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Abbreviation

Meaning

UDS

Ultrasonic Dilution Sensor

Table 6: Abbreviations

4 Description of System and Components 4.1

Front and Rear View

Figure 1: Front and Rear View

Front View: No.

Components

Description

1

Touch screen

15” Screen with touch-sensitive surface

2

Support stand

3

On/Off button

Press the button to switch the device on and off.

Table 7: Components Front View

Rear View: No.

Components

Description

4

Ventilation slot

The ventilation slot must remain unobstructed and must not be covered when the device is in operation!

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No.

Components

Description

5

VESA fixing

VESA MIS-D 75, (75 mm x 75 mm, M4) See 4.2 VESA Fixing

6

Sensor holder

Plastic holder to store the UDS for nonuse or transport

7

12 V DC; 5,5A Supply voltage

Input for 12 V DC supply voltage from medical power supply unit

8

NF-UDS : Connection for Ultrasonic Dilution Sensor

16-pin connecting socket

9

4 USB ports

USB ports for keyboard, mouse, printer and external storage media. Connecting lines should not exceed a length of 3.0 m. Connection restrictions: All devices connected here must demonstrably satisfy IEC 60601-1 or office equipment standard IEC 60950!

Table 8: Components Rear View

4.2

VESA Fixing

VESA is an international standard for the fixing of monitors and screens. D.med NephroFlow™ supports the VESA MIS-D 75 variant of this standard with four screws 75 mm x 75 mm apart with fastening screw thread M4 x 6 mm and a required screw-in depth of at least 4 mm and a maximum of 6 mm from the outer edge of the thread. Either four spacer sleeves or distance bolts shall be used which are at least 33 mm long with an outside diameter of 9 mm (-0.2 mm) (see figure below).

Figure 2: VESA mounting plate D.med NephroFlow Clinical Manual-en

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4.3

Ultrasonic Dilution Sensor

Figure 3: Components UDS

No.

Components

Description

1

Arterial Sensor

red labelled sensor to be connected at arterial line of dialysis tubing system

2

Venous Sensor

blue labelled venous sensor to be connected at venous line of dialysis tubing system

3

Y-Piece

4

Sensor cable

cable length: 2 m ±10%

5

Connector

Connect UDS at 16-pin connecting socket at rear of the device

Table 9: Components UDS

4.4

Power Supply

1

2

3

4

Figure 4: Power Supply Housing

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No.

Components

1

Housing

2

Cord set

3

Ferrite

4

12V DC- Connector

Description

Connect cord set with plug socket and connector at housing

Connect with socket at rear of device

Table 10: Components Power Supply

4.5

Connection of Peripheral Devices

The device has 4x USB interfaces, designed for keyboard, mouse, printer and USB memory stick. Peripheral Device Printer

Requirement

Information

The connected USB printers must satisfy the USB 2.0 standard.

Postscript-compatible printer with postscript driver.

USB Mouse

The minimum requirements are: Dual-button mouse USB2.0

The user can connect a USB mouse to the USB interface as an external input. This is supported in parallel with the touch screen input.

USB Keyboard

The connected keyboards must satisfy the USB 2.0 standard.

The following two external USB keyboard types are supported: American PC104 USB standard keyboard (QWERTY) German PC104 USB standard keyboard (QWERTZ)

USB Storage Media

USB 2.0 Supported file systems for storage media connected to USB port (USB memory sticks): FAT32, EX2, EX3

The system will not detect unformatted storage media!

Table 11: Peripheral Devices

4.6

USB Connection Restriction

All devices connected at the USB port must satisfy IEC 60601-1 or office equipment standard IEC 60950! Connecting lines must not exceed a length of 3.0 m.

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Medical systems Additional devices that are connected to medical electrical devices must demonstrably satisfy the relevant IEC or ISO standards (e.g. IEC 60950 for data-processing equipment). Furthermore, all configurations must comply with the normative requirements for medical systems (see IEC 60601-1-1 or Section 16 of the third edition of IEC 60601-1 in particular). Whoever connects additional devices to medical electrical equipment is responsible for configuring the system and must therefore ensure that the system satisfies the normative system requirements. Please note that local laws take priority over the normative requirements referred to above. If you have any queries, please contact our Service department (see 16 Contact Data).

5 Theory of Measurement D.med NephroFlow™ is designed to measure the Access Flow (Shunt Flow) and the Recirculation. The measurement is based on two ultrasonic sensor heads, which are clipped on the blood lines of the dialysis machine. The Device measures the relative change in speed of sound of the liquid in the bloodlines.

5.1

Access Flow Measurement

For measurement of the Access Flow the blood lines have to be crossed over at the access needles. The operator injects a bolus of saline solution into the venous return line of the dialysis machine. A part of this saline solution will go through the shunt to the arterial blood line. The device measures the amount of sodium in both blood lines by ultrasonic sensors.

Figure 5: Theory of access flow measurement The blue curve represents the dilution curve of the venous sensor, and the red curve represents the dilution curve of the arterial sensor. Out of this ratio the device calculates the current access flow in the dialysis shunt.

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5.2

Recirculation Measurement

For measurement of Recirculation the blood lines are in their original position for hemodialysis. The operator injects a bolus of saline solution into the venous return line of the dialysis machine. Due to recirculation in the shunt a part of the returned blood will be sucked in by the arterial blood pump. The device measures the amount of sodium in both blood lines by ultrasonic sensors.

Figure 6: Theory of Recirculation measurement

The blue curve represents the dilution curve of the venous sensor, and the red curve represents the dilution curve of the arterial sensor. Out of this ratio the device calculates the current recirculation in the dialysis shunt.

6 Installation – Preparing for Measurement Switch on device by pressing On/Off- Button on the left hand side. The device will do a self-check during start-up, after that the device is ready for measurement. Attach the sensor heads on dialysis tubing (red arterial sensor at arterial line, blue venous sensor at venous line) in a distance of 5-10 cm from the connector of the corresponding needle. Open the lid by pressing the latch, insert tubing and close the lid. Be sure to clip the Ultrasonic Dilution Sensors only on flexible dialysis tubing. Do not clip the Sensors on needle tubing. The LED of the power supply is its operating indicator. To disconnect the device from the mains pull the plug out of the wall socket or pull the plug of the mains cord out of the power supply. The power supply shall not be used where it is exposed to moisture or where water condensing may occur or it is exposed to constant vibrations. Never use the cord to pull the power supply from the mains. Always disconnect the power supply from mains during lighting storms or when not in use for a longer time to avoid damages.

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7 Description of Main Menu Functions Including Operation Modes

See 7.1 See 7.2 See 7.3 See 7.4 See 7.5 See 7.6 See 7.7 See 7.8

Figure 7: Main menu

7.1

Operation Mode

Here you can select between a Quick and Normal Mode of Operation. The change of the mode is possible during the runtime of the application. The quick mode allows you to perform a measurement without entering patient data. Measurements will not be stored on the hard disk. In Normal mode you can generate patient profiles and long term patient monitoring is possible. Measurements will be stored automatically on the hard disk. Other functions are identical in both modes.

7.2

Patient Database

Here you can access the patient database. In order to perform a measurement in normal mode, you must generate a patient profile in the patient database. For detailed information, see 8 Patient Database.

7.3

System Settings

Settings Set Time Set Time zone Touchscreen Calibration Language settings

Description This menu item enables you to set the time. This menu item enables you to set the time zone. This menu item enables you to calibrate the touch screen. The menu item enables you to change the application´s language. The change will take effect after system reboot.

Table 12: System settings D.med NephroFlow Clinical Manual-en

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You should make sure that the time is always correct as the time of the measurement is always recorded as this information is important for the chronological arrangement of the files If you have been running the system for more than five years and can no longer set the clock, the battery on the motherboard may need to be replaced. Please contact the service department for further assistance (see 16 Contact Data).

7.4

Printer Settings

The following settings are offered in the print out settings dialog:   

7.5

Enter Dialysis Center (up to 32 Characters) Choose A4 or Letter Activate/Deactivate printing of Patient Comments

Printer Installation

In this dialog you can install printers. The software guides you through the installation process. Please contact your local distributor for the latest printer drivers. Note: Each time you connect a new printer, you must install the corresponding driver.

7.6

Update Tubing Database

Here you have the possibility to update the tubing database from an external USB storage device. The name of the update package is: nftubings.bin. If a database is imported you will be informed if the import was successful. You must confirm overwriting the existing tubing database. If any error occurs during the update processes you will be informed. For further information about prospective tubing database, please contact your local distributor.

7.7

Manufacturer Information

Here you get information about the manufacturer, distributor and the software version installed on your device.

7.8

Service Here you can access the service functions of the device. The service menu is only for authorized personal and password protected. The Service functions are described in the service manual

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8 Patient Database By entering the database a table appears which includes the patient's Family Name, First Name and ID. Additionally the database provides the following options: Button Add Patient

Edit Patient

Delete Patient(s)

Export Report

Print Report

Open Report

Delete Record(s)

Export Database

Description This menu item enables you to add a patient into the database. There are two tabs, one named “Patient Data” for entering personal patient data and an obligatory ID, another one named “Comment” for entering a comment to the patient profile. Here you can change all entries for a patient. The “Edit Patient” dialog is identical to the “Add Patient” dialog filled with the data of a (previously selected) patient. This menu item enables you to delete one or more patient(s). Selected patients are highlighted. After selection of at least one patient the button "Delete Patient(s)" becomes active. By confirming this button the patient(s) and measurement data will be deleted. This menu item enables you to export the patient report in pdf format to an external USB storage device. This menu item enables you to print the patient report (if printer is installed and connected). Here you can open the patient report. This button becomes active when one patient is selected. For further information, see chapter 8.1 Detailed Information for “Patient Report”. This menu item enables you to delete all records of one or more patient(s). The button is only active when patient(s) are selected. You can export the patient database to an external storage device. The name of the database is given by the application software and is fixed. If the database is exported you will be informed if the export was successful.

Table 13: Patient Database

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8.1

Detailed Information for “Patient Report”

The Patient Report Dialog is accessible from the “Patient-Report-Button” and from the database (after a patient has been selected) and shows the measurement results of a selected patient. The measurement values are shown in a table and plot window. On top of the dialog the First Name, Family Name (both if available) and ID of the selected patient is presented. In the table all existing measurement values of the selected patient are listed chronologically with the latest measurement on top.

Figure 8: Patient Report

You can select one or more measurements by touching the corresponding row in the table. After selection, the row(s) is/are highlighted to add or edit a comment (if just one measurement was selected) or to delete the selected measurement(s). In the plot all measurements of the last 6 months are shown, retrospective starting with the month of the last measurement. With the “Print Report” button you can print the corresponding patient record. An “Export Report” button enables you to export the corresponding patient record to an external USB storage medium. Explanation of KDOQI Limit If the measured Access Flow is below 600 ml/min or is below 1000 ml/min and has been decreased more than 25% over a period of 4 months, you will be informed in the Patient Report in the column “KDOQI Limit”. Note: Grafts with access blood flows less than 600 to 800 ml/min have a greater rate of access thrombosis than grafts with flow rates greater than 800 ml/min. In addition to this absolute value, a decrease of 25% in access flow from a previous “stable” baseline greater than 1000 ml/min has been suggested as a criterion for further diagnostic evaluation of grafts, to detect the presence of at least one 50% (by diameter) stenosis within the access. (2006 Updates, Clinical Practice Guidelines and Recommendations, National Kidney Foundation.)

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