Barkey Prismacomfort Instructions for Use Ver 1.00 GB July 2010

Contents

Barkey Prismacomfort instruction manual

Contents 1 1.1 1.2 1.3 1.4

Introduction ... 1 Important things to observe... 1 Pictograms, signal words and symbols ... 1 Target groups ... 2 Copyright ... 2

2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9

Fundamental product characteristics ... 3 The Barkey autocontrol 3XPT controller ... 4 The holder on the Barkey autocontrol 3XPT controller... 5 The Barkey autoline XPT 4R heating device ... 6 Holder for Barkey autoline XPT 4R heating device... 6 Device functions ... 7 Overtemperature protection ... 7 Safety characteristics ... 8 Conformities ... 8 Further development ... 8

3 3.1 3.2 3.3 3.4 3.4.1 3.4.2 3.4.3

Use in accordance with regulations / Safety information ... 9 Safety information for using the device ...10 Safety information for handling the device ...12 Safety information regarding environmental influences...13 Electromagnetic properties / safety clearances ...14 Electromagnetic outputs ...14 Electromagnetic immunity ...15 Recommended protective distances ...18

4 4.1 4.2 4.2.1

Displays and controls... 19 Operating panel ...19 Symbols on labels ...20 Safety information sticker for Barkey autoline XPT 4R heating device ...21

5 5.1 5.2 5.2.1 5.2.2 5.2.3 5.2.4 5.3 5.4 5.5 5.6 5.6.1 5.6.2

Installation and initial startup ... 22 Setup locatioon ...22 Installation of the Barkey Prismacomfort ...22 Installing the controller ...22 Installation of holder for Barkey autoline XPT 4R heating device ...23 Installation of cable guide for Barkey autoline XPT 4R heating device ...25 Installing the Barkey autoline XPT 4R heating device ...26 Connecting the Barkey autoline XPT 4R heating device to the controller ...27 Positioning the Barkey autocontrol 3XPT controller ...29 Placing the blood return flow line in the heating device ...31 Start-up ...33 Connecting the Barkey autocontrol 3XPT controller to the mains ...33 Switching the Barkey autocontrol 3XPT controller on ...34

6 6.1 6.2 6.2.1 6.2.2

Operation ... 35 Main screen ...35 Menu structure ...36 Temperature measurement ...37 Adjusting the setpoint channel 1 ...38

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe – Germany - Head Office: +49 (5202) 9801-0 Customer Service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - e-mail: [email protected]

Barkey Prismacomfort instruction manual

Contents

6.2.3 6.2.4 6.2.5 6.2.6 6.2.7 6.2.8

Adjusting the setpoint channel 2 ... 39 Night operation ... 40 Language selection... 40 System information ... 41 Information channel 1 ... 41 Information channel 2 ... 42

7

Cleaning and care ... 43

8 8.1 8.2

Maintenance ... 44 Safety inspections (SI) ... 44 Replacing the battery... 45

9

Error messages ... 46

10

Guarantee and customer service ... 49

11

Specifications ... 51 Device master form Conformity declaration Quality Management System Certificate

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe – Germany - Head Office: +49 (5202) 9801-0 Customer Service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - e-mail: [email protected]

Barkey Prismacomfort instruction manual

Introduction

1

Introduction This instruction manual is intended to introduce the Barkey Prismacomfort Blood Heater for Gambro Prismaflex CFM system device functions that are used for initial startup, use and maintenance of the device.

1.1

Important things to observe WARNING Read these instructions for use thoroughly through before you start to use the device. It is imperative that you observe the information about correct use and the safety information contained in Chapter 3 of this manual. You should get to know the basic functions of the device in Chapter 2 in order to understand this chapter better. You should also observe the requirements made on the qualifications of those using the device stated in Chapter 1.3. 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 instruction manual. The installation conditions and safety information contained in this instruction manual must be unconditionally observed when using the device. This ensures that the device is not used improperly such that patients or users of the device could be endangered, and prevents damage to the device. Barkey GmbH & Co. KG accepts no liability for any damage is caused by nonobservance of this instruction manual.

1.2

Pictograms, signal words and symbols Warnings, and especially advice, are labelled using the following pictograms and symbol words in this instruction manual. WARNING

If not observed: hazards to personnel.

CAUTION

If not observed: hazards for equipment, the device or elementary device functions.

NOTE

Additional helpful guidelines and information. (the "i" stands for "information")

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1

Barkey Prismacofort instruction manual

Introduction

You will find the following symbol in instructions about the use and maintenance of the device: Instruction stage. carry out this stage as indicated.

►

NOTE The symbols representing the displays in controls and device displays, in addition to the symbols on device labels, are listed in Chapter 4 of this instruction manual together with their meanings. 1.3

Target groups These instructions for use are intended for: •

specialist medical personnel in hospitals who are able to show an acknowledged completion of specialist training in a medical profession,

•

and for specialist medical technicians who can prove an accepted vocational training as an electronic device electronics engineer or equivalent training. WARNING Only personnel who have fulfilled these qualifications may use or maintain the device.

1.4

Copyright This instruction manual, including all images contained within, is protected by copyright regulations. Translation, duplication, reprinting, extraction of images, reproduction using photographic technology and saving and processing in electronic systems, even only excerpts, in addition to any alterations requires 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 always stated without reference to the registration or copyright status. Existing industrial property rights and registered trademarks will be explicitly acknowledged. We reserve the right to make printing errors, mistakes and revisions which serve technical progress, or which are necessary due to changes in regulations.

2

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Barkey Prismacomfort instruction manual

Fundamental product characteristics

2

Fundamental product characteristics Barkey autocontrol 3XPT controller Holder for Barkey autoline XPT 4 R Prismaflex

Screws for fixing holder and plastic clip for mains cable routing

Barkey autoline XPT 4 R

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 controller

•

a holder for mounting a Barkey autoline XPT 4R (heating profile for blood return flow line) on the Prismaflex CFM device

•

two screws for fixing the holder on the Prismaflex CFM device

•

a plastic clip for cable routing

•

a Barkey autoline XPT 4R heating profile with 6.55 mm diameter and length 1.69m

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Barkey Prismacofort instruction manual

2.1

Fundamental product characteristics

The Barkey autocontrol 3XPT controller

Operating panel

Carrying handle

Holding plate Heating device connections

Ventilation grille

Front view

Rear view

Figure 2: Barkey autocontrol 3XPT controller

The Barkey autocontrol 3XPT controller is capable of regulating up to two connected Barkey autoline XPT 4R heating profiles to the preset setpoint. The setpoint can be adjusted between ranges of +33 °C up to +43°C for each heating profile. The current temperature for the heating profile is shown in the display. The Barkey autocontrol 3XPT controller has two connection sockets on the front panel for connecting the heating profiles. The serial interface on the bottom of the device is only authorised for communication devices approved by the manufacturer.

4

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Fundamental product characteristics 2.2

Barkey Prismacomfort instruction manual

The holder on the Barkey autocontrol 3XPT controller

Figure 3: Bracket

The holder is used for fitting the Barkey autocontrol 3XPT controller onto the Prismaflex CFM device. The holding plate is screwed to the device holder (available from Gambro sales offices) on the Prismaflex CFM device. Only the screws supplied with the device holder may be used for fixing. The two grooves on the holding plate are designed to hang the end of the Barkey autoline XPT 4R heating device in if the heating device is not being used. This prevents the heating device affecting the scales in the Prismaflex CFM system, or becoming soiled or damaged by touching the floor.

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Barkey Prismacofort instruction manual

2.3

Fundamental product characteristics

The Barkey autoline XPT 4R heating device The Barkey autoline XPT 4R heating device is used to heat the return blood flow line from the Prismaflex CFM device. It is intended for use with an infusion tubing diameter of 6.55 mm. Other heating devices are available as an alternative for blood return flow lines of smaller diameters. These heating devices are not included in delivery and can be optionally ordered from Gambro sales offices (Gambro Order No.: G99001901). The length of the heating profiles matches the filter set tubing lengths. CAUTION When installing, ensure that the Barkey autoline XPT 4R heating device does not affect the Prismaflex CFM device scales.

Figure 4: Barkey autoline XPT 4R heating device

2.4

Holder for Barkey autoline XPT 4R heating device

Figure 5:heating profile holder for Barkey autoline XPT 4R heating device

The heating profile holder is designed to mount the Barkey autoline XPT 4R heating device. The holder is fitted on the right-hand side of the the Gambro Prismaflex CFM device housing. CAUTION When installing, ensure that the Barkey autoline XPT 4R heating device does not affect the Prismaflex CFM device scales.

6

Barkey GmbH & Co. KG - Gewerbestrasse 8 - 33818 Leopoldshoehe – Germany - Head Office: +49 (5202) 9801-0 Customer Service: +49 (5202) 9801-30 Fax: +49 (5202) 9801-99 - e-mail: [email protected]

Fundamental product characteristics

2.5

Barkey Prismacomfort instruction manual

Device functions The Barkey Prismacomfort blood heater for the Gambro Prismaflex CFM system is an electronically controlled heating device for blood return flow lines of 6.55 mm diameter on the Prismaflex CFM device. Heat transfer to the blood return flow line takes place using a silicon profile with integrated heating. The blood return flow line to be heated is placed in the heating device and is completely enclosed by it. The complete enclosure of the lines to be heated ensures that there are no heat losses to the surroundings.The heat produced by the heating profile is therefore transferred to the fluid at maximum efficiency. The heating device temperature can be adjusted within a range of +33°C up to +43°C. The Barkey Prismacomfort blood heater works independently of the Gambro Prismaflex CFM device There is no electronic connection between the devices.

2.6

Overtemperature protection The Barkey autocontrol 3XPT controller is fitted with overtemperature protection for each channel which adapts to the setpoint selected. This overtemperature protection value is always 1° C above the setpoint selected. After the device has been switched on or after a heating device has been connected, this overtemperature protection is first set to the maximum value in order to avoid error messages from prewarmed heating devices. As soon as the actual value falls below the setpoint, the overtemperature protection is automatically set to a value of 1°C above the setpoint. A second overtemperature protection is integrated into every heating device which has a set point preset in our works for each heating device type. This overtemperature protection value is between 45.5°C +/- 1.5°C for the Barkey autoline XPT 4R heating device. The temperature in the heating device is monitored by a separate measuring sensor for the second overtemperature protection. The overtemperature protection switch-off function is implemented in the controller by an independent circuit. As soon as a heating device temperature reaches one of both overtemperature protection values, both channels are automatically switched off, and the heating devices connected cool down. The error display illuminates and an acoustic signal is sounded. An error message is shown in the display. Error messages are identified by numbers and listed in chapter 9.

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Barkey Prismacofort instruction manual

2.7

2.8

Fundamental product characteristics

Safety characteristics •

Safe and protected heating conditions due to maximum temperature settings of 43°C in addition to dual overtemperature protection circuits which switch off permanently on overtemperature.

•

No pressure changes in extracorporeal bloodstream due to additional tubing

•

No connection errors due to additional tubing

•

Automatic recognition of heating devices connected.

•

Plain text displays in the appropriate language.

•

Clearly located and labelled displays and controls.

•

Device designed for continuous operation.

•

Plastic housing, corrosion-free and energy-efficient .

Conformities The following applies to the Barkey Prismacomfort for Prismaflex: •

is allocated Class IIb in accordance with MDD* 93/42/EEC.

•

complies with the basic requirements from Appendix I in Directive MDD 93/42 EEC dated 12th July 1993. This is ensured in particular by the following standards: DIN EN 60601-1 DIN EN 60601-1-2

•

observance of the fundamental requirements and standards through the use of a certified quality assurance system in accordance with DIN EN ISO 13485 Issue November 2003 and Directive MDD 93/42 EEC Appendix II.3 of 12th July 1993 is documented.

* MDD
Medical Device Directive 2.9

Further development The Barkey Prismacomfort is the result of continuous teamwork between scientists, specialist experts, users and 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.

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Use in accordance with regulations / Safety information

3

Barkey Prismacomfort instruction manual

Use in accordance with regulations / Safety information The Barkey Prismacomfort blood heater for the Gambro Prismaflex CFM system is a heating device for blood return flow lines between the Gambro Prismaflex CFM device and the patient. The device can be used on the Gambro Prismaflex CFM device in any infusion cases where the patient is to be protected from cooling. WARNING If infusion solutions or medications are heated up in the Barkey Prismacomfort, you must ensure that their effectiveness is retained at the site temperature and that heating up is approved by the manufacturer of the medication. The Barkey autoline XPT 4R heating device included in delivery is designed for blood return flow line diameters of 6.55 mm. Other blood return flow line diameters to Prismaflex CFM devices will not be optimally heated with this heating device. Other heating devices are available as an alternative for blood return flow lines of smaller diameters. These heating devices are not included in the scope of delivery and can be purchased separately via Gambro sales offices. The holders are intended exclusively for fitting to the Prismaflex CFM device manufactured by Gambro. The Barkey Prismacomfort blood heater is designed for continuous operation and must not be set to temperatures higher than 37°C if the flow speed is under 100 ml/h. It is designed for room temperatures between 10°C and 40°C. An external temperature sensor for measuring room temperature or for other nondiagnostic applications can be connected to the Barkey autocontrol 3XPT controller. Only external temperature sensors approved by Barkey GmbH & Co. KG may be used. These external temperature detectors are not medical electro-thermometers or thermometers approved for medical use. These summarised statements on the use in accordance with regulations for the device are supplemented in this instruction manual by the individual descriptions of various applications and handling of the device, in addition to the safety information. You can find these descriptions in chapters 3 to 8 of this instruction manual. Please use these chapters to find specific information about usage of the device in individual cases.

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Barkey Prismacofort instruction manual

3.1

Use in accordance with regulations / Safety information

Safety information for using the device Read the instruction manual thoroughly through before WARNING using the device. Only use the device in accordance with the regulations as described previously in this chapter and in agreement with the processes described in this instruction manual. If infusion solutions or medications are heated by the Barkey Prismacomfort for Prismaflex CFM device, you must ensure that their effectiveness is retained at the site temperature and that heating is approved by the manufacturer of the medication. The controller may only be fixed to the device holder on the Prismaflex CFM device using the special holder to the rear of the Barkey autocontrol 3XPT controller part in accordance with the methods described in this instruction manual. You may only use the special holder on the Prismaflex CFM device for fixing the heating device holder in accordance with the procedures described in this instruction manual. The Barkey Prismacomfort may only be attached and transported in the position described in Chapter 5 of this instruction manual. The Barkey Prismacomfort may only be operated with accessories authorised by Barkey GmbH & Co. KG (ses Chapter 2). If any other accessories are used, increased emissions or reduced fault-free operation of the device can occur. The heating device connection head must be firmly placed in the holder provided. Do not kink, cover, warm or cool the heating device! Do not cover the heating device with cloth or bandage material, and do not run it below bedcovers or warm air blankets. Do not subject it to direct sunlight or direct heating. Only run the heating device uncovered through air. Do not run into or through incubators! Do not shorten or damage the heating device. The heating device and the electrical cables belonging to the Barkey Prismacomfort must be routed so that influences on the Prismaflex CFM device (e.g. scales) are safely avoided in accordance with this instruction manual (Chapt. 5) If the overtemperature alarm sounds, fluid feed to the patient must be stopped immediately.

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Use in accordance with regulations / Safety information

WARNING

WARNING

Barkey Prismacomfort instruction manual

If the Prismaflex CFM device is stopped and the Barkey autoline XPT 4R heating device is cooled simultaneously, overheating of the fluid in the tubes cannot be ruled out. The Barkey Prismacomfort blood warmer must not be set to temperatures higher than 37°C for flow speeds of below 100 ml/h. The external temperature sensors sold by Barkey GmbH & Co. KG are not medicinal electric thermometers and therefore may not be used for medically relevant measurements (e.g. patient temperature). After being connected to the Barkey autocontrol 3XPT, a heating profile must remain connected for a period of at least 6 seconds. If not, the parameters saved in the heating device cannot be correctly recognised. After disconnecting a heating profile from a Barkey autocontrol 3XPT, you must wait at least 6 seconds before connecting another heating device. If not, the parameters saved in the heating device cannot be correctly recognised. The device must not be used if it is damaged. A check of the device must be carried out by Barkey GmbH & Co. KG, representatives of Gambro Renal Products sales company or other authorised personnel.

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Barkey Prismacofort instruction manual

3.2

Use in accordance with regulations / Safety information

Safety information for handling the device Before using the device, read this instruction manual and the user documentation for the optional accessories through WARNING thoroughly. All electrical installations must comply with the relevant applicable regulations and standards in addition to the specifications stated by the manufacturer. Only power supply connections supplied by Barkey GmbH & Co. KG which are designed for the device rated voltage 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 device contains no parts which can be repaired by the user. Do not carry out repairs to the device yourself. Please contact the manufacturer or your medical technician service, who can request information about overhauls from the manufacturer if necessary. Overhaul measures and device modifications may only be carried out by Barkey GmbH & Co. KG, representatives of Gambro Renal Products sales company or other authorised personnel. You must clean and disinfect the heating profile after every application. A technical safety inspection must be carried out annually by qualified service personnel, representatives of the Gambro sales company or employees of Barkey GmbH & Co. KG. A battery change (lithium battery CR 1225, 3 V) must be carried out every three years by qualified service personnel, CAUTION representatives of the Gambro sales company or employees of Barkey GmbH & Co. KG. Overhaul measures and device modifications may only be carried out by qualified service personnel, representatives of Gambro sales company or employees of Barkey GmbH & Co. KG.

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Use i n accordance with regulations / Safety information 3.3

Barkey Prismacomfort instruction manual

Safety information regarding environmental influences The influence of stronger electromagnetic fields (e.g. through the use of HF therapy or surgical devices) can lead WARNING to malfunctions in the device. If such malfunctions occur, increase the distance between the Barkey Prismacomfort and the device causing the disturbance, 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 device can be influenced outside the limit values set by EN 60601-1-2. The Barkey Prismacomfort may not be used immediately next to other devices or stacked on top of other devices. If operation is required in the vicinity of, or stacked on top of, other devices is necessary, Barkey Prismacomfort must be observed in order to check its correct operation in such locations. Portable and mobile high-frequency communication equipment such as mobile telephones can influence the device. The device may not be used 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 nitrous oxide whose point of ignition 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 simultaneously. The device may not be set up or operated in the immediate vicinity of devices with high heat output. When setting up the device, you must ensure that there is free ventilation at the rear and bottom of the controller.

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Barkey Prismacofort instruction manual

3.4 3.4.1

Use in accordance with regulations / Safety information

Electromagnetic properties / safety clearances Electromagnetic outputs Guidelines and manufacturers declaration - electromagnetic outputs The Barkey autocontrol 3XPT is intended for operation in one of the environments stated below. The customer or user of the Barkey autocontrol 3XPT must ensure that it is operated in one of these environments. Interference output measureElectromagnetic environCompliance ments ment - guidelines The Barkey autocontrol 3XPT uses high-frequency energy exclusively for internal funcHF outputs in accordance with tions. This means that the Group 1 CISPR 11 high-frequency output is very low, and that it is improbable that neighbouring electronic devices are affected. HF outputs in accordance with Class B The Barkey autocontrol 3XPT CISPR 11 is suitable for use in rooms other than living space, and Overtone output in accordance Class A as such are directly conwith IEC 61000-3-2 nected to a public supply netOutput of voltage fluctuations / In agreement work which is also used to flicker in accordance with IEC supply buildings used for resi61000-3-3 dential purposes.

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Use in accordance with regulations regulation s / Safety information 3.4.2

Barkey Prismacomfort instruction manual

Electromagnetic immunity Guidelines and manufacturers declaration - electromagnetic immunity The Barkey autocontrol 3XPT is intended for operation in one of the electromagnetic environments stated below. The customer or user of the Barkey autocontrol 3XPT must ensure that it is operated in one of these environments. Immunity IEC 60601 test Electromagnetic environCompliance level checks level ment - guideline The floor should be con± 6 kV ± 6 kV Discharge of structed in wood or concrete contact discontact static electricity or be covered with ceramic charge discharge (ESD) in accortiles. If the floor is covered with synthetic material, the dance with ± 8 kV air dis± 8 kV air disIEC 61000-4-2 relative humidity must be at charge charge least 30%. ± 2 kV for Rapid transient mains power ± 2 kV for mains The quality of the supply electrical noise / supplies power supplies voltage should comply with bursts in accora typical business or hospidance with ± 1 kV for input ± 1 kV for input tal environment. IEC 61000-4-4 and output and output cabling cabling Surges in accordance with IEC 61000-4-5

± 1kV push-pull ± 1kV push-pull voltage voltage

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

± 2kV Not applicable common mode (Safety Class II) voltage < 5 % UT < 5 % UT (> 95 % drop (> 95 % drop of The quality of the supply of UT ) UT ) for 1/2 period voltage should comply with for 1/2 period a typical business or hospi60 % UT Voltage dips, 60 % UT tal environment. If the user short-time inter- (40 % drop of (40 % drop of UT ) of the Barkey autocontrol UT ) for 5 periruptions and for 5 periods 3XPT requires continued ods fluctuations of use even if the power supply supply voltage in 70 % UT is interrupted, we recom70 % UT accordance with (30 % drop of (30 % drop of UT ) mend that the Barkey autoIEC 61000-4-11 UT ) for 25 pericontrol 3XPT is connected for 25 periods ods to an uninterrupted power < 5 % UT < 5 % UT supply or a battery. (> 95 % drop (> 95 % drop of of UT ) for 5s UT ) for 5s Magnetic field at 3 A/m 3 A/m Magnetic fields at mains supply frefrequency should comply quency with the typical values to be (50/60 Hz) in found in business and hospiaccordance with tal environments. IEC 61000-4-8 NOTE UT Is the power supply alternating voltage before application of testing rules

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Barkey Prismacofort instruction manual

Use in accordance with regulations / Safety information

Guidelines and manufacturers declaration - electromagnetic immunity The Barkey autocontrol 3XPT is intended for operation in one of the electromagnetic environments stated below. The customer or user of the Barkey autocontrol 3XPT must ensure that it is operated in one of these environments. Immunity IEC 60601 Electromagnetic environment Compliance level checks test level - guideline Portable and mobile radio devices should not be used closer to the Barkey autocontrol 3XPT, including its mains cable, than the recommended protective distance which is calculated to the appropriate equation depending on transmission frequency. Recommended protective distance

d = 1,17 P d = 1,17 P Conducted HFdisturbance in accordance with IEC 610004-6

for 80 MHz to 800 MHz 3 Veff 150 kHz to 80 Mhz

3 V/m Radiated HF 80 MHz to disturbance in 2.5 GHz accordance with IEC 61000-4-3

3 Veff 150 kHz to 80 Mhz

d = 2,33 P

for 800 MHz to 2,5 GHz with P as the transmitter nomi3 V/m nal output in watts (W) in ac80 MHz to 2.5 GHz cordance with the information provided by the transmitter manufacturer and d as recommended protective distance in metres (m). The field strength of stationary transmitters should always be b less than the compliance level at all frequencies in accordance a with an on-site investigation . Interference is possible in the immediate vicinity of devices which show the following symbol.

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Use in accordance with regulations / Safety information

Barkey Prismacomfort instruction manual

NOTE 1 The higher frequency level applies at 80 MHz and 800 MHz. NOTE 2 These guidelines are not necessarily applicable in all cases. The propagation of electromagnetic magnitudes is influenced by absorption and reflection within the building, 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. In order to determine the electromagnetic environment with regard to stationary transmitters, you should consider carrying out a study of the instrument location. If the measured field strength at the location at which the Barkey autocontrol 3XPT is being used exceeds the above compliance levels, the Barkey autocontrol 3XPT should be observed to ensure that the device is functioning normally. If unusual performance characteristics are observed, it may be necessary to use additional measures such as different alignment or a new location for the Barkey autocontrol 3XPT. b The field strength should be lower than 3 V/m above the frequency range 150 kHz to 80 MHz.

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