XPT heating system User Manual Ver 5 GB Oct 2013

User Manual

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File Name: xpt_heating_system_user_manual_ver_5_gb_oct_2013.pdf

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User manual Barkey XPT heating system Version 5 GB Issue 2013-10-23 Barkey autocontrol 3XPT Barkey autoline XPT 4R Barkey autotherm XPT

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

User manual Barkey XPT heating system

Contents

Table of Contents 1

Introduction ... 1 1.1

Important things to observe ... 1

1.2

Pictograms, signal words and symbols ... 2

1.3

Target group... 2

1.4

Disclaimer of liability ... 2

1.5

1.6

Conformities... 3

1.7

Further development ... 3

Barkey autocontrol 3XPT ... 4 2.1

Overtemperature protection... 5

2.2

Contra-indications ... 5

2.3

Safety features ... 5

2.4

Intended purpose / Use for the intended purpose ... 6

2.5 2.5.1 2.5.2 2.5.3

Safety instructions... 7 Safety instructions for using the device ... 7 Safety instructions on handling the device ... 9 Safety instructions and environmental influences... 10

2.6 2.6.1 2.6.2 2.6.3

Electromagnetic properties / safety distances ... 11 Electromagnetic outputs ... 11 Electromagnetic immunity ... 12 Recommended safety distance ... 14

2.7 2.7.1 2.7.2 2.7.3 2.7.4 2.7.5

Controls and displays ... 15 Operating panel ... 15 Symbols on labels ... 16 Safety instructions sticker for Barkey autoline XPT 4R heater ... 17 Connection area ... 18 Stand clamp... 18

2.8 Operation... 20 2.8.1 Getting started ... 20 2.8.1.1 Installation location ... 20 2.8.1.2 Installing the device ... 21 2.8.1.3 Connecting the power cord... 21 2.8.1.4 Connecting the heaters ... 22 2.8.1.5 Connecting an optional temperature measurement sensor... 23 2.8.1.6 Switching on ... 23 2.8.1.7 Login screen... 24 2.8.1.8 Main screen... 24 2.8.1.9 Switching off ... 25 User manual Barkey XPT heating system - V5 GB - ac-200-EW-0000-07 - 2013-10-23 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49(0)5202-9801-0 Customer service: +49(0)5202-9801-30 Fax: +49(0)5202-9801-99 - e-mail: [email protected]

User manual Barkey XPT heating system

Contents

2.8.2 Calling up the devices functions that are displayed as menu items ... 25 2.8.2.1 Menu overview ... 25 2.8.2.2 Calling up the menu ... 26 2.8.2.3 "Temperature measurement" device function ... 27 2.8.2.4 "Set value channel 1" and "Set value channel 2" device functions ... 29 2.8.2.5 "Overnight mode" device function ... 31 2.8.2.6 "Language selection" device function ... 32 2.8.2.7 "Information System" device function ... 33 2.8.2.8 "Channel 1 information" and "Channel 2 information" device functions . 34

Barkey autoline XPT 4R ... 36 3.1

Device functions ... 37

3.2

Safety features ... 37

3.3

Intended purpose / Use for the intended purpose ... 38

3.4 3.4.1 3.4.2 3.4.3

Safety instructions... 39 Safety instructions for using the device ... 39 Safety instructions on handling the device ... 41 Safety instructions and environmental influences ... 42

3.5 Components of the heater ... 43 3.5.1 Wärmeprofil mit Steuerleitung ... 43 3.5.2 Support with stand clamp ... 44 3.6 3.6.1 3.6.2 3.6.3 3.6.4

Getting started ... 44 Installation location ... 44 Installing the heater... 45 Inserting the infusion tube ... 46 Connecting the heater ... 47

Barkey autotherm XPT ... 49 4.1

Device functions ... 50

4.2

Safety features ... 50

4.3

Intended purpose / Use for the intended purpose ... 51

4.4 4.4.1 4.4.2 4.4.3

Safety instructions... 52 Safety instructions for using the device ... 52 Safety instructions on handling the device ... 54 Safety instructions and environmental influences ... 55

4.5

Components of the heater ... 56

4.6 4.6.1 4.6.2 4.6.3 4.6.4

Getting started ... 57 Installation location ... 57 Installing the heater... 58 Application ... 58 Connecting the heater ... 59

User manual Barkey XPT heating system - V5 GB - ac-200-EW-0000-07 - 2013-10-23 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49(0)5202-9801-0 Customer service: +49(0)5202-9801-30 Fax: +49(0)5202-9801-99 - e-mail: [email protected]

User manual Barkey XPT heating system

Contents 5

Cleaning and care ... 61

Maintenance ... 62

6.1

Technical safety inspection (TSI) ... 62

6.2

Replacing the battery ... 63

Error messages... 64 7.1

Barkey autocontrol 3XPT error codes ... 65

7.2

Error codes for heater channel 1 ... 66

7.3

Error codes for heater channel 2 ... 66

Warranty and disclaimer ... 67

Customer Service ... 68

Factory settings for temperature... 69

Specifications ... 70 11.1

Barkey autocontrol 3XPT ... 70

11.2

Barkey autoline XPT 4R ... 71

11.3

Barkey autotherm XPT ... 72

Device master data sheet template Declaration of Conformity Certificates

User manual Barkey XPT heating system

Introduction

Introduction This user manual is intended as an introduction to the commissioning, use and maintenance of the following devices:   

1.1

Barkey autocontrol 3XPT control unit Barkey autoline XPT 4R heater profile Barkey autotherm XPT heater jacket

Important things to observe WARNING Carefully read through this user manual before using the device. Comply strictly with the instructions for correct use and the safety instructions contained in this user manual. For a better understanding of these chapters you should familiarise yourself with the basic functions of the device as described at the start of Chapters 0 to 4. You should also comply with the requirements for the training and skills of persons using the device, as indicated in Chapter 1.3. WARNING Medical electrical devices are subject to particular precautionary measures with regard to EMC (electromagnetic compatibility). Make sure that the devices are installed and commissioned in accordance with the EMC advice 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 devices. This will ensure that the devices are handled properly and that patients and users cannot be put at risk nor equipment damaged. Barkey GmbH & Co. KG can accept no liability for damage caused as a result of failure to follow this user manual.

User manual Barkey XPT heating system - V5 GB - ac-200-EW-0000-07 - 2013-10-23 1 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49(0)5202-9801-0 Customer service: +49(0)5202-9801-30 Fax: +49(0)5202-9801-99 - e-mail: [email protected]

User manual Barkey XPT heating system

1.2

Introduction

Pictograms, signal words and symbols These instructions use the following pictograms and symbol words to highlight warnings and special advice: WARNING

If not observed: danger to people.

CAUTION

If not observed: Gefahr for Sachen, das Gerät oder elementare Gerätefunktionen.

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. Carry out this step as indicated.

►

NOTE The symbols that are associated with the controls and indicators on the devices, and the symbols on the stickers on the devices are explained in Chapter 0 of this user manual. 1.3

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 these requirements may use and service the devices.

1.4

Disclaimer of liability The manufacturer and/or its subsidiary companies can accept liability for the safety, reliability and performance of the systems only provided that all operating procedures, adjustments and repairs are carried out by properly trained and qualified personnel; provided that all modifications to the device are authorised in writing by the manufacturer carried out by properly trained and qualified personnel; provided that the electrical installation of the treatment room complies with local regulations and IEC requirements (where they apply); and provided that the devices are used according to the published user manuals (these documents).

Introduction 1.5

User manual Barkey XPT heating system

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. 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 corrections of typographical errors and mistakes and to make changes in the interests of technical progress or which are necessary due to changes in regulations.

1.6

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

1.7

Further development The devices in the Barkey XPT heating system are the result of continuing development team work between scientists, technical experts, users and Barkey GmbH & Co. KG. Barkey GmbH & Co. KG is continuing to make further developments and add new features to the XPT product line and will ensure compatibility between the Barkey autocontrol 3XPT control unit and the Barkey XPT heaters.

User manual Barkey XPT heating system - V5 GB - ac-200-EW-0000-07 - 2013-10-23 3 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49(0)5202-9801-0 Customer service: +49(0)5202-9801-30 Fax: +49(0)5202-9801-99 - e-mail: [email protected]

User manual Barkey XPT heating system

Barkey autocontrol 3XPT

Figure 1: Barkey autocontrol 3XPT

The Barkey autocontrol 3XPT control unit is capable of controlling up two Barkey XPT heaters to the pre-set value at the same time. Depending on the heater that is connected, the set value for each heater can be set within the range +33 °C to +43 °C for each heater. The Barkey autocontrol 3XPT detects various different heaters as they are connected and automatically performs the settings for the relevant control requirements. 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). The Barkey autocontrol 3XPT is controlled by means of a operating panel which is equipped with buttons, a large display and indicator lamps. In addition the device is equipped with an acoustic buzzer which serves to draw attention to any faults that occur. The Barkey autocontrol 3XPT is equipped with a mounting lug on the back. This allows it to be mounted on either an infusion stand or a standard rail. The back wall of the device is shaped at the top into a grip recess, so that the user can safely carry and manipulate the device by hand.

Barkey autocontrol 3XPT 2.1

User manual Barkey XPT heating system

Overtemperature protection The Barkey autocontrol 3XPT control unit is equipped with a 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 for the heater that is connected. After the device 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. This second overtemperature protection monitors the temperature in the heater via a separate measurement sensor. 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 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 7.

2.2

Contra-indications There are no known contra-indications in relation to heating and keeping warm transfusions, infusions and fluids (purging solutions), for the avoidance of hypothermia.

2.3

Safety features

         

Safe control of the heating conditions at the connected heaters by permanently pre-set temperature bands restricted to a safe range and by dual-band overtemperature protection, which permanently shuts down the device in the event of overtemperature. When the Barkey infusion heating system is used it ensures there is no degradation of important and sensitive biological components of the blood and blood products due to excessive temperatures When the Barkey patient heating system is used it ensures there is no disturbance or injury to the patient due to excessive temperatures Plain local language text displays Clearly arranged and labelled displays and controls. Device is designed for continuous operation Power supply to the heaters via a non-hazardous safety low voltage Automatic cut-out if overtemperature occurs in the power electronics Corrosion-free plastic casing Secure attachment of the device with a sturdy stand clamp

User manual Barkey XPT heating system - V5 GB - ac-200-EW-0000-07 - 2013-10-23 5 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49(0)5202-9801-0 Customer service: +49(0)5202-9801-30 Fax: +49(0)5202-9801-99 - e-mail: [email protected]

User manual Barkey XPT heating system

2.4

Barkey autocontrol 3XPT

Intended purpose / Use for the intended purpose The purpose of the Barkey autocontrol 3XPT active medical device is to act as a control unit for two active therapeutic heaters for heating and keeping warm whole blood, erythrocyte concentrates, infusion solutions and other substances and materials to + 37°C in a way that is hygienic, corresponds to patients' needs, biologically protective and safe. The Barkey autocontrol 3XPT has the following areas of application:

  

Heating and keeping warm whole blood, blood products and plasma conserves when connected to Barkey infusion heating system heaters Continuous operation heating and keeping warm non-denaturisable infusion solutions when connected to Barkey infusion heating system heaters Protection of patients against chilling and overheating when connected to Barkey patient heating system heaters

The Barkey autocontrol 3XPT be used whenever it is desirable to prevent the chilling of patients as a result of cold transfusions and infusion solutions. These summarised statements on the intended use of the device are supplemented in this user manual by specific descriptions of the various different applications and of the handling of the device. You will find these descriptions in Chapters 0 to 2.8 of this user manual. Please use these chapters to find specific information about usage of the device in individual cases.

Barkey autocontrol 3XPT

User manual Barkey XPT heating system

2.5

Safety instructions

2.5.1

Safety instructions for using the device The device and its system components must be checked WARNING before every use to ensure they are all intact. Damaged devices must not be used. In order not to put the safety of the patient or operator at risk, do not use the device if one of the following conditions applies: - The power cords, mains plugs, control leads, plugs or sockets are damaged or worn - The casing or operating panel is damaged - The device has been dropped or its internal electronic components have become wet - The device does not heat correctly (as displayed by optical and acoustic alarms) - The yellow alarm lamp and/or acoustic alarm (on the display) is activated - The heater is damaged. All electrical installations must comply with the relevant applicable regulations and standards, in addition to the specifications stated by the manufacturer. Before using the Barkey autocontrol 3XPT control unit, thoroughly read all the relevant chapters in this user manual, together with all chapters on the heaters that will be connected. Before using the temperature measurement sensors, read the associated user documentation. The manufacturer can accept no liability for the safety of the patient if the operating, maintenance and adjustment 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. Only use the device in accordance with the regulations as described previously and in accordance with the processes described in this user manual. The Barkey autocontrol 3XPT control unit may be operated only in conjunction with Barkey XPT series heaters. Before the Barkey autocontrol 3XPT is used with a heater, both devices must be allowed to acclimatise at the place of use for at least an hour at ambient temperature. If heaters are connected to the Barkey infusion heating system to heat or keep warm infusion solutions or medicaments, the user must make sure that the temperature settings at the device are appropriate and that the controls are effective. If this is not so, the user must adjust the temperature settings to values appropriate to the infusion solutions or medicaments.

User manual Barkey XPT heating system - V5 GB - ac-200-EW-0000-07 - 2013-10-23 7 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49(0)5202-9801-0 Customer service: +49(0)5202-9801-30 Fax: +49(0)5202-9801-99 - e-mail: [email protected]

User manual Barkey XPT heating system

WARNING

Barkey autocontrol 3XPT

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 will not be recognised correctly. 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 will not be recognised correctly. The heater contains no parts which can be repaired by the user. Do not carry out repairs to the heater yourself. Please contact Barkey GmbH & Co. KG or your medical technician service, who can request information about repair from the manufacturer. Repairs and modifications to the device may only be carried out by Barkey GmbH & Co. KG or authorised personnel. The infusion system and/or patient heating system can be used at ambient temperatures from +10 °C to +40 °C and is suitable for continuous operation. If a malfunction alarm occurs during self-test, the system must not be used. Call a trained qualified service technician. If the Barkey autocontrol 3XPT is operated with accessories, these must exclusively be those approved by Barkey GmbH & Co. KG. The use of unapproved accessories can lead to increased radiated electromagnetic emissions (EMI) or reduce the device's immunity to electromagnetic interference. If the overtemperature alarm sounds, allow the temperature of the heaters to fall to a value less than the maximum permissible set temperature for the heater that is connected. Otherwise the supply of fluids to the patient must be stopped immediately or the heater disconnected from the patient. Only measurement sensors approved by Barkey GmbH & Co. KG may be connected to the external temperature measurement sensor port. These external temperature sensors are not medical thermometers and therefore they may not be used for medical purposes (such as taking the patient's temperature). The control unit must not be used if it has a fault. The control unit should be examined by Barkey GmbH & Co. KG or by an authorised person.

Barkey autocontrol 3XPT 2.5.2

User manual Barkey XPT heating system

Safety instructions on handling the device Before using the Barkey autocontrol 3XPT control unit, thoroughly read all the relevant chapters in this user manual, WARNING together with all chapters on the heaters that will be connected. Before using the temperature measurement sensors, read the associated user documentation. 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. The mains plug must be removed from the mains socket to ensure safe isolation of the device from the power supply. Using cleaning products and disinfectants other than as described in this User manual can damage the device. Check with the manufacturer before using cleaning agents which are not expressly recommended for use. In particular, you are warned against the use of the following solutions: - halogenated aromatic and aliphatic solvents; - ketonic solvents. The device contains no parts which can be repaired by the user. Do not carry out repairs to the device yourself. Please contact Barkey GmbH & Co. KG or your medical technician service, who can request information about repair from the manufacturer. Repairs and modifications to the device may only be carried out by Barkey GmbH & Co. KG or authorised personnel. An annual technical safety inspection must be carried out by qualified service personnel 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 or CAUTION employees of Barkey GmbH & Co. KG. The 3XPT infusion and patient heating system must be cleaned regularly. Before cleaning the 3XPT infusion heating system it must be disconnected from the mains supply by withdrawing the power plug from the mains socket. The device rating plate can be found at the bottom of the back panel. The power supply requirements and the serial number ("SN") of the device are specified on this.

User manual Barkey XPT heating system - V5 GB - ac-200-EW-0000-07 - 2013-10-23 9 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49(0)5202-9801-0 Customer service: +49(0)5202-9801-30 Fax: +49(0)5202-9801-99 - e-mail: [email protected]

User manual Barkey XPT heating system

2.5.3

Barkey autocontrol 3XPT

Safety instructions and environmental influences The influence of strong electromagnetic fields (e.g. through the use of HF therapy or surgical devices) can lead to malfunctions WARNING in devices of the Barkey XPT heating system. If interference of this type occurs, increase the distance between the XPT device suffering interference and the device causing the interference, or do not operate both devices at the same time. XPT devices work perfectly within the interference limit values set in the EN 60601-1-2 standard. XPT devices can be affected by interference outside the limit values set by EN 60601-1-2. The 3XPT infusion heating system 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 3XPT infusion heating system 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 XPT devices. Do not use XPT devices 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℃. In particular, it is imperative that XPT devices are not used in the same areas where alcohol disinfectants and anaesthetising substances are being used at the time. Only power supply cords supplied by Barkey GmbH & Co. KG which are designed for the rated voltage of the device may be used. The operation of accessories, converters or cabling in conjunction with devices or systems other than those listed here can lead to increased emissions or reduced device immunity. XPT devices may not be operated in the immediate vicinity of devices with a high thermal discharge output. Cables must be laid where they cannot affect the operation of any other devices.

Barkey autocontrol 3XPT

User manual Barkey XPT heating system

2.6

Electromagnetic properties / safety distances

2.6.1

Electromagnetic outputs 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 means that HF HF emissions to CISPR 11 Group 1 emission is very low, and neighbouring electronic devices are unlikely to be affected. HF emissions to CISPR 11 Class B The Barkey autocontrol 3XPT is suitable for use in buildings other Harmonic emissions to IEC 61000- Class A than residential and those which are 3-2 directly connected to a public Emission of voltage Complies supply network which is also used fluctuations/flickering to to supply buildings used for IEC 61000-3-3 residential purposes.

User manual Barkey XPT heating system - V5 GB - ac-200-EW-0000-07 - 2013-10-23 11 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49(0)5202-9801-0 Customer service: +49(0)5202-9801-30 Fax: +49(0)5202-9801-99 - e-mail: [email protected]

User manual Barkey XPT heating system

2.6.2

Barkey autocontrol 3XPT

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 ± 6 kV The floor should be constructed in ± 6 kV Contact wood or concrete or be covered Static discharge Contact discharge with ceramic tiles. If the floor is (ESD) to discharge covered with synthetic material, IEC 61000-4-2 ± 8 kV air the relative humidity must be at ± 8 kV air discharge 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 ± 1kV voltage ± 1kV voltage phase-to-phase phase-to-phase The quality of the supply voltage Surges to IEC should comply with a typical 61000-4-5 ± 2kV Not applicable business or hospital environment. voltage phase-to- (double insulated earth class II) < 5 % UT < 5 % UT (> 95 % drop of (> 95 % drop of UT ) The quality of the supply voltage UT ) for 1/2 cycle should comply with a typical for 1/2 cycle business or hospital environment. 40 % UT 40 % UT Voltage dips, If the user of the Barkey ( 60 % drop of ( 60 % drop of UT ) short-time autocontrol 3XPT requires interruptions and UT ) for 5 cycles for 5 cycles continued operation even if the fluctuations of 70 % UT power supply is interrupted, we 70 % UT supply voltage to (30 % drop of (30 % drop of UT ) recommend that the Barkey IEC 61000-4-11 UT ) for 25 autocontrol 3XPT is connected to for 25 cycles cycles an uninterruptible power supply < 5 % UT < 5 % UT or to a battery. (> 95 % drop of (> 95 % drop of UT UT ) for 5s ) for 5s Magnetic field at 3 A/m 3 A/m Magnetic fields at mains supply frequency frequency should comply with the (50/60 Hz) in typical values as found in accordance with business and hospital IEC 61000-4-8 environments. NOTE: UT is the mains AC supply before applying the test rule

User manual Barkey XPT heating system

Barkey autocontrol 3XPT

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 Electromagnetic environment Immunity test Compliance level test level guidelines Portable and mobile radio sets should not be used within a distance from the Barkey autocontrol 3XPT including its cords that is less than the recommended safety distance as calculated by the relevant equation for the transmitted frequency. Recommended safety distance Wire-borne HF 3 Veff d = 1.17 √P 3 Veff interference to 150 kHz to 150 kHz to 80 MHz for 150 kHz to 80 MHz IEC 61000-4-6 80 MHz Radiated HF interference to IEC 61000-4-3

3 V/m 80 MHz to 2.5 GHz

d = 1.17 √P 3 V/m 80 MHz to 2.5 GHz

for 80 kHz to 800 MHz d = 2.33 √P for 800 MHz to 2.5 GHz where P is the nominal power of the transmitter in Watts (W) as stated by the transmitter manufacturer and d is the recommended safety distance in metres (m). An on-site investigation must show that the field strength a of stationary transmitters is less than the compliance level b at all frequencies. Interference is possible near devices that display the following symbol.

NOTE 1 The higher frequency level applies at 80 MHz and 800 MHz. NOTE 2 These guidelines may not apply in all cases. The propagation of electromagnetic variables is affected by absorption and reflection of buildings, objects and people. a The field strength of stationary transmitters, such as base stations of radio telephones and mobile land radios, amateur radios, AM and FM radio and television transmissions cannot be precisely theoretically predetermined. You should consider carrying out a site study to determine the electromagnetic environment with regard to stationary transmitters. If the measured field strength at the location where the Barkey autocontrol 3XPT is being used exceeds the above compliance levels, the Barkey autocontrol 3XPT should be monitored to ensure that the device is functioning as intended. If unusual performance characteristics are observed, additional measures such as changing the alignment or location of the Barkey autocontrol 3XPT may be necessary. b The field strength should be less than 3 V/m in the frequency range 150 kHz to 80 MHz.

User manual Barkey XPT heating system - V5 GB - ac-200-EW-0000-07 - 2013-10-23 13 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49(0)5202-9801-0 Customer service: +49(0)5202-9801-30 Fax: +49(0)5202-9801-99 - e-mail: [email protected]

User manual Barkey XPT heating system

2.6.3

Barkey autocontrol 3XPT

Recommended safety distance Recommended safety distances between portable and mobile HF telecommunications devices and the Barkey autocontrol 3XPT The Barkey autocontrol 3XPT is intended for operation in an electromagnetic environment in which HF interference is controlled. The customer or user of the Barkey autocontrol 3XPT can help avoid electromagnetic interference by observing the minimum distance between portable and mobile HF communications devices (transmitters) and the Barkey autocontrol 3XPT as stated below, depending on the output power of the communication device. Safety distance depending on transmitter frequency m Nominal 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz transmitter power W d  1.17 P d  1.17 P d  2.33 P 0.01 0.12 0.12 0.23 0.1 0.37 0.37 0.74 1 1.17 1.17 2.33 10 3.69 3.69 7.38 100 11.67 11.67 23.33 For transmitters whose maximum nominal output is not given in the above table, the recommended safety distance d in metres (m) can be calculated using the equation belonging to the appropriate column, where P is the maximum nominal output of the transmitter in Watts (W) as stated by the transmitter manufacturer. NOTE 1 The higher frequency level applies at 80 MHz and 800 MHz. NOTE 2 These guidelines may not apply in all cases. The propagation of electromagnetic variables is affected by absorption and reflection of buildings, objects and people.

User manual Barkey XPT heating system

Barkey autocontrol 3XPT 2.7

Controls and displays

2.7.1

Operating panel The Barkey autocontrol 3XPT device is provided with an operating panel on the front with a multi-line display, 4 buttons and 4 lights (LEDs). On/Off button Operation indicator

Störungsanzeige Display

Operation indic channel 1 (LED)

Operation indic channel 2 (LED)

Selection button Confirmation button Figure 2: Operating panel

Button for turning the device on and off.

Selection button for input in the user dialogue. Each button has its function shown in the display. Confirmation button for input in the user dialogue. Each button has its function shown in the display. The green light (LED) shows that the device has been switched on. 1

The two orange operation indicators (LEDs) are each assigned to a channel of the autocontrol 3XPT and indicate that a heater is connected and has been detected. The yellow light (LED) indicates a device malfunction.

The display is for

   

information about the heaters currently connected and their temperature set values and actual values, displaying the menu for operation of the device, displaying the status of the various device functions that can be called up using the menu, and outputting error messages.

An acoustic signal transmitter indicates when an error has occurred. A message is additionally shown in the display in the event of errors. User manual Barkey XPT heating system - V5 GB - ac-200-EW-0000-07 - 2013-10-23 15 Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe - Germany - Switchboard: +49(0)5202-9801-0 Customer service: +49(0)5202-9801-30 Fax: +49(0)5202-9801-99 - e-mail: [email protected]

User manual Barkey XPT heating system

2.7.2

Barkey autocontrol 3XPT

Symbols on labels Labels showing printed symbols are affixed to the Barkey XPT heating system devices. These have the following meaning:

This symbol declares that the device conforms with EU Directive 93/42/EEC of 14th June 1993 for medical devices. The four-digit number indicates the appointed body (TÜV Product Service) which supervises the manufacturer's quality assurance system.

IP X1

This symbol means that the device is protected against vertically dripping water (incident angle to the vertical 0°) to IEC 601-1 in its intended operating conditions.

This symbol indicates that the device with its application part is of type CF (cardio floating) and is defibrillation proof.

This symbol indicates that the electrical protective insulation within the device protects the user from electric shocks and that the device does not need to be connected to the protective earth cable of the building's alternating current power supply (double insulated class II).

This symbol shows the year of manufacture as a four-digit number.

2014 This symbol identifies the month and the year in which the next safety inspection must be carried out.

This symbol advises you that you must comply with the user manual supplied.

This symbol indicates that the mains plug must be withdrawn from the socket before the device housing is opened.

This symbol indicates the humidity range which the medical device can be safely exposed to. The values limiting humidity are located next to the upper and lower horizontal line. You can find the limit values in the “Technical data” section.

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Barkey GmbH & Co. KG

Barkey Heating Products

XPT heating system User Manual Ver 5 GB Oct 2013