Prismacomfort Instructions for Use ver 3 EN Dec 2015

Instructions for Use

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Instructions for use Barkey Prismacomfort blood heater for Gambro Prismaflex® Version Issue

3 EN 2015-12-07

Sales by: Gambro Lundia AB Monitor Division Box 10101 SE-220 10 Lund Sweden

Manufactured by: Barkey GmbH & Co. KG Gewerbestrasse 8 33818 Leopoldshoehe Germany

Contents

Instructions for use Barkey Prismacomfort

Contents 1

Introduction ... 1 1.1

Important things to observe ... 1

1.2

Pictograms, signal words and symbols ... 2

1.3

Intended purpose ... 2

1.4

Target group... 3

1.5

Contra-indications ... 3

1.6

Disclaimer ... 3

1.7

Fundamental product characteristics ... 4 2.1

The Barkey autocontrol 3XPT control unit ... 5

2.2

The lug on the Barkey autocontrol 3XPT control unit ... 6

2.3

The Barkey autoline XPT 4R heater ... 7

2.4

Support for the Barkey autoline XPT 4R heater ... 7

2.5

Device functions ... 8

2.6

Overtemperature protection... 8

2.7

Safety features ... 9

2.8

Conformities... 9

2.9

Further development ... 9

Use for the intended purpose / safety instructions ... 10 3.1

Safety instructions for using the device ... 11

3.2

Safety instructions on handling the device ... 13

3.3

Safety instructions and environmental influences ... 14

3.4

Electromagnetic properties / safety distances ... 15

3.4.1 Electromagnetic outputs ... 15 3.4.2 Electromagnetic immunity ... 16 3.4.3 Recommended safety distance ... 18

Controls and displays ... 19 4.1

Operating panel ... 19

4.2

Symbols on labels ... 20

4.3

Safety instructions sticker for Barkey autoline XPT 4R heater ... 22

Setting up, getting started ... 23

Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

Contents

5.1

Set-up location ... 23

5.2

Installation of the Barkey Prismacomfort... 23

5.2.1 Installing the control unit ... 23 5.2.2 Installing the Barkey autoline XPT 4R heater support ... 25 5.2.3 Installing the cable guide for the Barkey autoline XPT 4R heater ... 27 5.2.4 Installation of the Barkey autoline XPT 4R heater ... 27 5.3

Connection of the Barkey autoline XPT 4R heater to the control unit 29

5.4

Positioning the Barkey autocontrol 3XPT control unit... 31

5.5

Inserting the blood return flow tube into the heater ... 33

5.6

Getting started ... 35

5.6.1 Connecting the Barkey autocontrol 3XPT control unit to the power supply 35 5.6.2 Switching on the Barkey autocontrol 3XPT control unit ... 35

Operation ... 36 6.1

Main screen ... 36

6.2

Menu structure ... 37

6.2.1 Temperature measurement ... 38 6.2.2 Set value setting, channel 1 ... 39 6.2.3 Set value setting, channel 2 ... 40 6.2.4 Nighttime mode... 41 6.2.5 Language... 41 6.2.6 System information ... 42 6.2.7 Information channel 1 ... 42 6.2.8 Information channel 2 ... 43

Cleaning and care ... 44

Maintenance ... 45 8.1

Technical safety inspection (TSI) ... 45

8.2

Replacing the battery ... 46

Error messages ... 47

Warranty and disclaimer of liability ... 50

Customer Service ... 51 11.1

Service information ... 53

Contents

Instructions for use Barkey Prismacomfort

Specifications ... 59

Appendix: Prismacomfort master data sheet Declaration of Conformity Quality Management System Certificate

Instructions for use Barkey Prismacomfort

Introduction

Introduction This user manual is intended as an introduction to the functions of the Barkey Prismacomfort blood heater for the Gambro Prismaflex haemodialysis system. It covers the commissioning, use and maintenance of this unit.

1.1

Important things to observe WARNING Carefully read through this user manual before using the device. It is imperative that you observe the information about correct use and the safety instructions contained in Chapter 3 of this user manual. For a better understanding of this chapter you should familiarise yourself with the basic functions of the device as described in Chapter 2. You should also comply with the requirements for the training and skills of persons using the device, as indicated in Chapter 1.4. WARNING Medical electrical devices are subject to particular precautionary measures with regard to EMC (electromagnetic compatibility). Please ensure that the device is installed and operated in accordance with the EMC guidelines contained in this user manual. You must follow the conditions of use and safety instructions contained in this user manual at all times when using the device. This will ensure that there is no improper handling of the device which might put patients or users of the device at risk and result in damage to the device. Barkey GmbH & Co. KG accepts no liability for damage caused as a result of failure to follow this user manual.

Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 1 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

1.2

Introduction

Pictograms, signal words and symbols This user manual uses the following pictograms and symbol words to highlight warnings and special advice. WARNING

If not observed: danger to people.

CAUTION

If not observed: danger to property, the device or basic functions of the device.

NOTE

Additional helpful advice and information. (The "i" stands for "information".)

You will find the following symbol in instructions about the use and maintenance of the device: Step contained in instructions. Perform this step as indicated.

►

NOTE The symbols representing the controls and device displays, and the symbols used on device labels, are listed and described in Chapter 4 of this user manual.

1.3

Intended purpose The Barkey Prismacomfort blood heater for the Gambro Prismaflex haemodialysis system is a heater for use on the blood return flow tubes between the Gambro Prismaflex haemodialysis system and the patient. The device can be used with the Gambro Prismaflex haemodialysis system in all cases where it is necessary to prevent the patient suffering a fall in temperature. CAUTION In the event of high rates of blood flow exchange with Prismaflex hemodialysis apparatus, the patient may experience hypothermia despite use of the Barkey Prismacomfort blood warmer. If, in spite of using the Barkey Prismacomfort blood warmer, the patient should experience hypothermia, additional measures must be taken to stabilise the body temperature. In this case, Barkey recommends using active warming systems for the patient (e.g. thermal conductive or connective blankets) to provide additional warmth.

2 Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

Introduction

1.4

Target group This user manual is intended for use by: 

medical specialists in hospitals who hold a recognised vocational qualification in medicine,



and specialist medical technicians who hold an accepted vocational qualification as an electrical device electronics engineer or equivalent training WARNING Only personnel who meet requirements may use and service the device.

1.5

Contra-indications There are no known contra-indications in relation to heating the Gambro Prismaflex blood return flow tube.

1.6

Disclaimer The manufacturer and/or its subsidiary companies are liable for the safety, reliability and performance of the system only if all operating procedures, calibrations and repairs are carried out by suitably trained and qualified personnel; if all alterations to the device have been approved in writing by the manufacturer and have been carried out by suitably trained and qualified personnel; if the electrical installation within the treatment room satisfies local regulations and, if applicable, IEC requirements; if the devices are used in accordance with the published user manual (these documents).

1.7

Copyright This user manual and all illustrations it contains are protected by copyright. Translation, duplication, reprinting, extraction of images, reproduction using photographic technology and storage and processing in electronic systems, even only as excerpts, or any alterations shall require the written authorisation of Barkey GmbH & Co. KG. KG. Any further usage which goes beyond using the contents described in connection with the product purchased is not permitted. Third party products, protected trademarks etc. are stated without reference to the registration or copyright status as a matter of principle. Existing industrial property rights and registered trademarks are explicitly acknowledged. We reserve the right to make typographical errors, mistakes and modifications in the interest of technical progress, or which are necessary due to changes in regulations.

Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 3 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

Fundamental product characteristics

Fundamental product characteristics Support for Barkey autoline XPT 4R Prismaflex

Screws for attaching the support and the plastic clip for the cable guide

Barkey autocontrol 3XPT control unit

Barkey autoline XPT 4R

Figure 1: Barkey Prismacomfort for Prismaflex

The Barkey Prismacomfort blood heater for the Gambro Prismaflex haemodialysis system consists of the following components: 

the Barkey autocontrol 3XPT control unit



a support for mounting a Barkey autoline XPT 4R (heater profile for the blood return flow tube) on the Prismaflex haemodialysis system



two screws for attaching the support to the Prismaflex haemodialysis system



a plastic clip for the cable guide



a Barkey autoline XPT 4R heater with a diameter 6.55 mm and a length of 1.7 m

4 Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

Fundamental product characteristics

2.1

The Barkey autocontrol 3XPT control unit

Operating panel

Carrying handle Lug

Connections for the heaters

Ventilation grille Connection for an external sensor Front view

Rear view Figure 2: Barkey autocontrol 3XPT control unit

The Barkey autocontrol 3XPT control unit is capable of controlling up two Barkey autoline XPT 4R heaters to the pre-set value at the same time. The set value can be set within the range +33 °C to +43 °C for each heater. The display shows the current temperature of the heater. Two connection sockets are provided on the front of the Barkey autocontrol 3XPT control unit for connection of the heater profiles. Access using the serial interface on the underside of the device is reserved for communications devices approved by the manufacturer. An ambient temperature sensor or a sensor for measuring temperatures can be connected to the connection for an external sensor. WARNING External temperature sensors sold by Barkey are not medical electrical thermometers and therefore must not be used for medical measurements (such as the patient's temperature).

Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 5 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

2.2

Fundamental product characteristics

The lug on the Barkey autocontrol 3XPT control unit

Figure 3: Lug

The lug is for attaching the Barkey autocontrol 3XPT control unit to the Prismaflex haemodialysis system. The lug is screwed to the bracket on the Prismaflex haemodialysis system. The screws used must be those supplied with the bracket. The bracket must be ordered from the Gambro sales office. The end of the Barkey autoline XPT 4R heater can be secured to the two slots on the lug when the heater is not in use. This avoids the risk that the heater interferes with the Prismaflex haemodialysis system scales or is damaged or contaminated by contact with the ground.

6 Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Fundamental product characteristics

2.3

Instructions for use Barkey Prismacomfort

The Barkey autoline XPT 4R heater The purpose of the Barkey autoline XPT 4R heater is to heat the Prismaflex haemodialysis system blood return flow tube. It is designed to suit an infusion tube diameter of 6.55 mm. Other heaters are available as an alternative to suit blood return flow tubes with smaller outside diameters. These heaters are not part of the scope of supply and can be ordered as required from Gambro sales offices (Gambro item no.: G99001901). The lengths of the heaters match the tube lengths of the filter set. CAUTION When installing the Barkey autoline XPT 4R heater, take care it does not interfere with the Prismaflex haemodialysis system scales.

Figure 4: Barkey autoline XPT 4R heater

2.4

Support for the Barkey autoline XPT 4R heater

Figure 5: Support for the Barkey autoline XPT 4R heater

The purpose of the support for the heater is to provide a mounting point for the Barkey autoline XPT 4R heater. The lug is attached to the right side of the casing of the Gambro Prismaflex haemodialysis system. CAUTION When installing the Barkey autoline XPT 4R heater, take care it does not interfere with the Prismaflex haemodialysis system scales.

Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 7 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

2.5

Fundamental product characteristics

Device functions The Barkey Prismacomfort blood heater for the Gambro Prismaflex haemodialysis system is an electronically controlled temperature regulation system for blood return flow tubes with 6.55 mm diameter connected to the Prismaflex haemodialysis device. The heat is transmitted to the blood return flow tube via a silicone profile with integral heaters. The blood return flow tube to be heated is laid in the heater and completely enveloped by it. This complete enveloping of the tube being heated ensures no heat is lost to the environment. This means there is the maximum amount of heat transfer from the silicone profile to the fluid which is to be heated. The temperature of the heaters can be set within a range +33 °C to +43 °C. The Barkey Prismacomfort blood heater operates entirely independently from the Gambro Prismaflex haemodialysis system. There is no electrical connection between the two systems.

2.6

Overtemperature protection The Barkey autocontrol 3XPT control unit is equipped with separate overtemperature protection for each channel. This operates by reference to the set value. This overtemperature protection value is defined as 1°C above the respective set value. After the system has been switched on or after connection of a heater this overtemperature protection is at first set to the maximum value so as to avoid false alarms if the heaters had previously been heated. As soon as the actual temperature falls below the set value overtemperature protection is automatically initiated at a value 1°C above the set value. Each heater incorporates a second overtemperature protection which is factory-set to a value specific to the type of heater. For Barkey autoline XPT 4R this overtemperature protection value is 45.5 °C ± 1.5 °C. A separate measurement sensor monitors the temperature in the heater on behalf of the second overtemperature protection. The overtemperature protection cutout function is implemented within the control unit as an independent circuit. At soon as the temperature of one of the heaters reaches one of the two overtemperature protection values, both channels are switched off automatically and the connected heaters start to cool down. The fault indication on the control unit lights up and an acoustic signal sounds. An error message is shown in the display. The error messages are identified by numeric codes, which are listed in Chapter 9.

8 Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Fundamental product characteristics

2.7

2.8

Instructions for use Barkey Prismacomfort

Safety features 

Safe and gentle heating conditions are ensured by a maximum temperature setting of 43 °C plus dual-function overtemperature protection which switches the unit off permanently in the event of overtemperature.



There are no additional disposable items that might cause changes in pressure of the extracorporal blood circuit.



There are no additional disposable items that might cause incorrect connections.



The connected heaters are detected automatically.



Plain text displays in the local language.



Clearly arranged and labelled displays and controls.



Device is designed for continuous operation.



The plastic casting is corrosion-free and saves energy.

Conformities Full particulars regarding conformity can be found in the attached declaration of conformity.

2.9

Further development The Barkey Prismacomfort is the result of continuous teamwork between scientists, specialist experts, users and the Barkey GmbH & Co. KG. We reserve the right to make printing errors, mistakes and revisions which serve technical progress, or which are necessary due to changes in regulations.

Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 9 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

Use for the intended purpose / safety instructions

Use for the intended purpose / safety instructions The Barkey Prismacomfort blood heater for the Gambro Prismaflex haemodialysis system is a heating system for use on the blood return flow tubes between the Gambro Prismaflex haemodialysis system and the patient. The system can be used with the Gambro Prismaflex haemodialysis system in all cases where it is necessary to prevent the patient suffering a fall in temperature. WARNING If infusion solutions or medicaments are heated in the Barkey Prismacomfort you must ensure that their efficacy is maintained during heating and that the heating is approved by the manufacturer of the infusion solution. The Barkey autoline XPT 4R heater is designed for a blood return flow tube diameter of 6.55 mm. Other diameters of blood return flow tubes used with the Prismaflex haemodialysis system will not be properly heated by this heater. Other heaters are available to suit blood return flow tubes with smaller outside diameters. These heaters are not part of the scope of supply and can be ordered as required from Gambro agencies. The supports are designed exclusively for attachment to the Gambro Prismaflex haemodialysis system. The Barkey Prismacomfort blood heater is designed for continuous operation. It must not be set to a temperature higher than 37 °C if the flow velocity is less than 100 ml/h. It is designed for use at ambient temperatures from 10 °C to 40 °C. An additional external temperature sensor for measuring the ambient temperature or for other non-diagnostic applications can be connected to the Barkey autocontrol 3XPT control unit. Only those external temperature sensors approved by Barkey GmbH & Co. KG may be used. These external temperature sensors are not medical electrical thermometers or thermometers authorised for medical purposes. These general statements on the intended use of the device are supplemented in this user manual by individual descriptions of the application and of the handling of the device, and by safety instructions. You will find these descriptions in Chapters 3 to 8 of this user manual. Please use these chapters to find specific information about how to use the device in individual cases.

10 Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Use for the intended purpose / safety instructions

3.1

Instructions for use Barkey Prismacomfort

Safety instructions for using the device WARNING

Read this user manual thoroughly before using the heating system. Only use the system in accordance with the regulations as described previously in this chapter and in accordance with the processes described in this user manual. The manufacturer can accept no liability for the safety of the patient if the operating, maintenance and calibration procedures for the system deviate from the procedures described in this user manual or in the service manual. Persons using the device must be properly trained and qualified. If infusion solutions or medicaments are heated in the Barkey Prismacomfort blood heater for Prismaflex, you must ensure that their efficacy is maintained during heating and that the heating is approved by the manufacturer of the infusion solution. The control unit may be attached to the Prismaflex haemodialysis system bracket exclusively by means of the lug on the back of Barkey autocontrol 3XPT control unit in accordance with the instructions in this user manual. The heater may be attached exclusively to the support for heaters on the Prismaflex haemodialysis system in accordance with the instructions in this user manual. The Barkey Prismacomfort may be fitted and transported only in the positions described in Chapter 5 of this user manual. If the Barkey Prismacomfort is operated with accessories, these must exclusively be those approved by Barkey GmbH & Co. KG (see Chapter 2). The use of unapproved accessories can lead to increased radiated electromagnetic emissions (EMI) or reduce the device's immunity to electromagnetic interference. The heater connection head must be securely inserted in the holder provided for it! Do not kink, cover, warm or cool the heater! Do not cover the heaters with cloths or dressing materials, do not run it under bedcovers, hot-air covers, etc., and do not expose it to direct sunlight or thermal radiation. Only run the heater uncovered through the air. Do not run it into or through incubators. Do not shorten or damage the heater.

Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 11 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

WARNING

Use for the intended purpose / safety instructions

If a malfunction alarm sounds during self-test it means the device has failed the test. Do not use the system. Call a trained qualified service technician. The heaters and the electrical leads to the Barkey Prismacomfort should be laid in accordance with this user manual (Chap. 5) so as to ensure that there is no interference with the haemodialysis system and in particular the scales. If the overtemperature alarm sounds, the supply of liquids to the patient must be stopped immediately. If the haemodialysis system is brought to a stop and at the same time the Barkey autoline XPT 4R heater starts to cool down, the risk of overheating the liquid in the enveloped tubes cannot be excluded. If the flow velocity is less than 100 ml/h the Barkey Prismacomfort blood heater must not be set higher than 37 °C. External temperature sensors sold by Barkey GmbH & Co. KG are not medical electrical thermometers and therefore must not be used for measurements related to medical purposes (such as the patient's temperature). After being connected to the Barkey autocontrol 3XPT, a heater must remain connected for at least 6 seconds. Otherwise, the parameters saved in the heater cannot be correctly recognised. After disconnecting a heater from the Barkey autocontrol 3XPT, you must wait at least 6 seconds before connecting another heater. Otherwise, the parameters saved in the heater cannot be correctly recognised. The system must not be used if the device has a fault. The system must be checked by a trained and qualified service technician.

12 Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Use for the intended purpose / safety instructions

3.2

Instructions for use Barkey Prismacomfort

Safety instructions on handling the device WARNING

CAUTION

Before using the system, carefully read and familiarise yourself with this manual and the user documentation for the optional accessories. All electrical installations must comply with the relevant applicable regulations and standards, in addition to the specifications stated by the manufacturer. The user is responsible for correct installation. Only the power supply connections supplied by Barkey GmbH & Co. KG, which are designed for the rated voltage of the device, may be used. The mains plug must be removed from the mains socket to ensure safe isolation of the device from the power supply. The system contains no parts which can be repaired by the user. Do not carry out repairs to the system yourself. Please contact the manufacturer or your medical technician service, who can request information about overhauls from the manufacturer if necessary. Repair work and device modifications may only be carried out by Barkey GmbH & Co. KG, representatives of the Gambro Renal Products sales company or authorised personnel. Clean and disinfect the heaters after each use. Using cleaning products and disinfectants other than as described in this user manual can damage the device. Check with the manufacturer before using chemicals which are not explicitly recommended for use on the system. In particular, you are warned against the use of the following solutions:  halogenated aromatic and aliphatic solvents;  ketonic solvents. A technical safety inspection (TSI) must be carried out each year by qualified service personnel, representatives of the Gambro Renal Products sales company or employees of Barkey GmbH & Co. KG. The battery (lithium battery CR 1225, 3 V) must be replaced every three years by qualified service personnel, representatives of the Gambro Renal Products sales company or employees of Barkey GmbH & Co. KG. Repair work and device modifications may only be carried out by qualified service personnel, representatives of Gambro Renal Products sales company or employees of Barkey GmbH & Co. KG.

Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 13 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

3.3

Use for the intended purpose / safety instructions

Safety instructions and environmental influences WARNING

The influence of strong electromagnetic fields (e.g. through the use of HF therapy or surgical devices) can lead to malfunctions in the system. If interference of this type occurs, increase the distance between the Barkey Prismacomfort and the device causing the interference, or operate the devices at separate times. The Barkey Prismacomfort works perfectly within the limit values set in the EN 60601-1-2 standard. The system can be affected by interference that exceeds the limit values set by the EN 60601-1-2 standard. The Barkey Prismacomfort may not be used immediately next to other devices or stacked on top of other devices. If it is necessary to operate the device next to or stacked on top of other devices, the Barkey Prismacomfort should be monitored to check that it is working correctly in this situation. Portable and mobile HF communication equipment such as mobile phones can affect the system. Do not use the device in the immediate vicinity of  flammable materials (e.g. gases, liquids);  flammable mixtures of anaesthetic substances with air;  flammable mixtures of anaesthetic substances with oxygen or laughing gas whose flashpoint is below 50 °C. It is imperative that the device is not used in areas in which alcoholic disinfectants and anaesthetising substances are being used at the same time. The system may not be set up or operated in the immediate vicinity of devices with a high thermal discharge output. At installation, ensure free circulation of air to the back and underside of the control unit.

14 Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Use for the intended purpose / safety instructions

3.4

Electromagnetic properties / safety distances

3.4.1

Electromagnetic outputs

Instructions for use Barkey Prismacomfort

Guidelines and manufacturers declaration - Electromagnetic emission The Barkey autocontrol 3XPT is suitable for operation in any of the environments listed below. The customer or user of the Barkey autocontrol 3XPT must ensure that it is operated in one of these environments. Electromagnetic environment– Radiated EMI measurements Compliance Guidelines The Barkey autocontrol 3XPT uses high-frequency energy for internal functions only. This HF outputs in accordance with Group 1 means that HF emissions are CISPR 11 very low, and neighbouring electronic devices are unlikely to be affected. HF outputs in accordance with Class B The Barkey autocontrol 3XPT is CISPR 11 suitable for use in buildings other than residential and those which Harmonic output in accordance Class A are directly connected to a public with IEC 61000-3-2 supply network which is also Output of voltage fluctuations/ Complies used to supply buildings used for flickering to IEC 61000-3-3 residential purposes.

Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 15 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

Instructions for use Barkey Prismacomfort

3.4.2

Use for the intended purpose / safety instructions

Electromagnetic immunity Guidelines and manufacturers declaration - Electromagnetic immunity The Barkey autocontrol 3XPT is intended for operation in any of the electromagnetic environments listed below. The customer or user of the Barkey autocontrol 3XPT must ensure that it is operated in one of these environments. IEC 60601 test Electromagnetic environment Immunity test Compliance level level Guideline The floor should be made of ± 6 kV ± 6 kV Static electrical wood or concrete or be covered contact discharge contact discharge (ESD) with ceramic tiles. If the floor is discharge to covered with synthetic material, ± 8 kV air IEC 61000-4-2 the relative humidity must be at discharge ± 8 kV air discharge least 30%. ± 2 kV for power ± 2 kV for power Rapid transient cords cords The quality of the supply voltage electrical noise/ should comply with a typical bursts to ± 1 kV for input ± 1 kV for input and business or hospital environment. IEC 61000-4-4 and output cords output cords

Surges according to IEC 61000-4-5

Voltage dips, short-time interruptions and fluctuations of supply voltage to IEC 61000-4-11

Magnetic field at supply frequency (50/60 Hz) to IEC 61000-4-8

± 1 kV voltage phase-phase

± 2 kV voltage phaseearth < 5 % UT (> 95 % drop of UT ) for ½ cycle 40 % UT ( 60 % drop of UT ) for 5 cycles 70 % UT ( 30 % drop of UT ) for 25 cycles < 5 % UT (> 95 % drop of UT ) for 5s 3 A/m

Not applicable (double insulated, class II) < 5 % UT (> 95 % drop of UT ) for ½ cycle 40 % UT ( 60 % drop of UT ) for 5 cycles 70 % UT ( 30 % drop of UT ) for 25 cycles < 5 % UT (> 95 % drop of UT ) for 5s 3 A/m

The quality of the supply voltage should comply with a typical business or hospital environment.

The quality of the supply voltage should comply with a typical business or hospital environment. If the user of the Barkey autocontrol 3XPT requires continued operation even if the power supply is interrupted, we recommend that the Barkey autocontrol 3XPT is connected to an uninterruptible power supply or to a battery.

Magnetic fields at mains frequency should comply with the typical values as found in business and hospital environments. NOTE: UT is the mains AC supply voltage before applying the test rule

16 Instructions for use Barkey Prismacomfort - V3 EN - pc-100-EW-0005-02 - 2015-12-07 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49 (5202) 9801-0 Customer service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - Email: [email protected]

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Prisma Range

Prismacomfort Instructions for Use ver 3 EN Dec 2015