Barkey S-line Instructions For Use Manual Download Page 17

Safety information

Barkey GmbH & Co. KG  -  Gewerbestrasse 8  -  33818 Leopoldshoehe  -  Germany  -  Telephone: +49(0)5202-9801-0

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Service department: +49(0)5202-9801-30  Fax: +49 (0)5202-9801-99  -  email: [email protected]

Instructions for Use

Barkey S-line

3.3

 

Safety information for environmental influences

 WARNING

Medical electrical devices are subject to special safety meas-
ures with regard to EMC (electromagnetic compatibility).
Make sure that the device is installed and operated in accor-
dance with the EMC information contained in these instruc-
tions for use.
The influence of strong electromagnetic fields (eg through HF
treatment or surgical devices) can lead to malfunctions of the
Barkey S-line. In the event of such malfunctions, increase the
distance between the device that is malfunctioning and device
causing the malfunction, or do not operate the two devices at
the same time. The Barkey S-line functions perfectly within
the limit values of the standard EN 60601-1-2. The devices
may be influenced outside the limit values of the standard EN
60601-1-2.
The Barkey S-line may not be located directly next to or
stacked with other devices. If operations near to or stacked
with other devices are necessary, the Barkey S-line should be
observed in order to check its correct operation in this layout.
Portable and mobile HF communication devices, eg mobile
phones, can affect the devices.
The Barkey S-line may not be used in the vicinity of 
-

 

flammable substances (eg gases, liquids),

-

 

flammable mixtures of anaesthetics with air,

-

 

flammable mixtures of anaesthetics with oxygen or nitrous
oxide

whose flash point is below 50°C. In particular, the Barkey S-
line may not be used in areas in which alcoholic disinfectants
and anaesthetics are used at the same time.
Only power cables supplied by Barkey GmbH & Co. KG that
are dimensioned for the device's mains voltage may be used.
Using accessories, converters or conductors with devices or
systems other than those indicated can lead to an increased
emission or a reduced immunity to interference of the device.
The Barkey S-line may not be used in the direct vicinity of
devices with high waste heat production.
The lines must be laid in such a way that interference with
other devices is safely avoided.
The device is ventilated from the back. The air supply must not
be obstructed by covering or blocking the ventilation slots on
the back of the device.

Summary of Contents for S-line

Page 1: ...Instructions for Use Barkey Version 1 0 GB Issued on 2010 01 05 From SN 2900000 Manufactured by Barkey GmbH Co KG Gewerbestrasse 8 33818 Leopoldshoehe Germany...

Page 2: ......

Page 3: ...abels 7 2 5 Earthing stud 7 2 6 Use for the intended purpose 8 2 7 Contraindication 8 2 8 Safety features 8 2 9 Cooling the control unit 9 2 10 Overtemperature protector 9 2 11 Fault signal 9 3 Safety...

Page 4: ...5202 9801 30 Fax 49 0 5202 9801 99 e mail info barkey de Instructions for Use Barkey S line 4 2 5 Inserting the infusion line 24 5 Cleaning and care 26 6 Maintenance 27 7 Guarantee and disclaimer of l...

Page 5: ...device functions INFORMATION Additional useful pointers and information i stands for information You will see the following symbol in instructions for using the device Instruction step Carry out this...

Page 6: ...are indi cated in chapter 1 2 Medical electrical devices are subject to special safety measures with regard to the EMC electromagnetic compatibility Always make sure that the device is in stalled and...

Page 7: ...for Use Barkey S line 2 Device description Fig 1 Barkey S line The Barkey S line can be used to warm fluids that are administered to the patient through infusion lines The temperature of the warming s...

Page 8: ...ming section 2 Warming section The flexible warming section holds the infusion tube and transmits the heat to the flowing fluid 3 Warming section holder The warming section can be placed at its head a...

Page 9: ...ng the device s status Fig 3 Display and control panel The display and control elements are marked by symbols which are explained in the following table Touch panel for switching the device on and off...

Page 10: ...nitors the temperature in the warming section In case of a fault the operator is informed by the yellow luminous ring showing and by an acoustic signal INFORMATION In case of a fault the device s heat...

Page 11: ...ng devices connected to the Barkey S line are approved for use on the human body The device s so called application parts are type BF body floating In addition all devices in the Barkey S line are def...

Page 12: ...the device in detail 2 7 Contraindication The device may not be used to warm living organisms objects or fluids of any kind with the ex ception of those described in the intended purpose The device m...

Page 13: ...cess can take some minutes After this you can switch device on again However if the cause of the fault has not been eliminated the fault will occur again and the device must be inspected by a trained...

Page 14: ...any liability for the patient s safety if the operating maintenance and calibration procedures for the system do not conform to the procedures in the instruc tions and in the service manual Take accou...

Page 15: ...arming section This can cause a heat build up and the infusion line can be squeezed If the patient suffers from irritation of the skin in spite of the biocompatible material remove the warming device...

Page 16: ...s The device does not contain any parts that the owner can re pair Do not repair the device yourself Contact Barkey GmbH Co KG or your medical technical service which can request information on repair...

Page 17: ...next to or stacked with other devices If operations near to or stacked with other devices are necessary the Barkey S line should be observed in order to check its correct operation in this layout Port...

Page 18: ...is type of envi ronment Measuring emitted interference Conformity Electromagnetic environment guideline HF emissions in accordance with CISPR 11 Group 1 The Barkey S line uses HF energy exclusively fo...

Page 19: ...f a typi cal business or hospital environ ment Surges in accor dance with IEC 61000 4 5 1 kV voltage outerconductor outerconductor 2 kV voltage outerconductor earth 1 kV voltage outerconductor outerco...

Page 20: ...table and mobile radios should not be used at a distance from the Barkey S line including the con ductors that is less than the recom mended safe clearance that is calcu lated in accordance with the c...

Page 21: ...radio equipment amateur radio stations AM and FM radio and television transmitters cannot be determined accurately beforehand In order to determine the electromag netic environment with regard to the...

Page 22: ...hown below in dependence on the output power of the communications appliance Safe clearance in dependence on the transmission frequency m Transmitter s nominal output W 150 kHz to 80 MHz P d 17 1 80 M...

Page 23: ...st not be covered Fasten the Barkey S line to an infusion stand as shown in chapter 4 2 1 The control panel must be easily accessible the device operator must be able to read the display and the lamps...

Page 24: ...alarm lamps or acoustic alarm are activated 4 2 1 Fitting the device Fasten the Barkey S line to an infusion stand The fastening clamp for fitting the device is on the back of the device The vertical...

Page 25: ...t by turning in an anti clockwise direction Fig 6 Fix the device in place by tightening the fastening screw in a clockwise direction Fig 6 WARNING Do not clamp lines or tubes in the fastening slot Scr...

Page 26: ...30 Fax 49 0 5202 9801 99 email info barkey de Instructions for Use Barkey S line 1 2 3 4 5 6 Fig 7 Fitting the warming section in the holder WARNING The warming section may not be covered insulated wa...

Page 27: ...ings the specifications for the power supply and the serial number SN of the device Insert the plug for the mains cable into the socket for your power supply 4 2 3 Switching on Touch the ON OFF button...

Page 28: ...ne in the end of the warming section approx 3 cm downstream from the luer lock connection Move your thumb over the infusion line and press the line gently into the slot of the warming section Fig 9 sk...

Page 29: ...ey are suitable for the preset temperature in the device and retain their efficacy if this is not the case the operator must not use the device If the patient suffers from irritation of the skin in sp...

Page 30: ...e this cloth on the device Never put cleaning liquids into the device s ventilation openings Do not disinfect the device with steam eg in an autoclave hot air or with thermochemical agents Commerciall...

Page 31: ...uctions that can be requested from Barkey GmbH Co KG Servicing work may only be carried out by qualified service personnel or employees of Barkey GmbH Co KG On the last page of these instructions for...

Page 32: ...evice Barkey GmbH Co KG does not accept any responsibility or liability for the use of accessories other than those listed in these instructions for use for the use of components other than original c...

Page 33: ...r maintained on site it must be sent in Before shipping the device please note the following rules Send the defective device for recycling repair only to Barkey GmbH Co KG or an authorised sales partn...

Page 34: ...de Instructions for Use Barkey S line WARNING Barkey GmbH Co KG does not assume any liability for unauthorised alterations and repairs of the devices by the owner or unauthorised third parties Our rep...

Page 35: ...Fuse 2 5 A time delay Temperature setting 39 C Control precision 2 0 C Overtemperature protection warming section 43 0 C 1 0 C Warming up time From 20 C to 39 C approx 2 min Operations Storage transp...

Page 36: ...__________ Inventory number __________________________________________ Location __________________________________________ Date commissioned __________________________________________ Marking 0123 Man...

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