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Instructions for use 

 

 

automatic pressure controller 

 

 

 

 

Version 2018-07-31 

40-202-01 
 

 

ENG

 

Содержание autopress

Страница 1: ...Instructions for use automatic pressure controller Version 2018 07 31 40 202 01 ENG ...

Страница 2: ...al that the following warnings and safety instructions as well as the operating instructions are read and carefully observed by all users before first using the device It is the responsibility of those using the device to fully acquaint themselves with its proper use and operation If a malfunction is suspected the device is to be taken out of service immediately and suitable warning signs should b...

Страница 3: ... Initial Operation 7 4 Maintenance 9 5 Cleaning and Disinfection 9 6 Periodic Inspections 10 7 Manufacturer Liability 10 8 Warranty Conditions 11 9 Return of Devices 12 10 Disposal 12 11 Symbols 13 12 Operating and Storage Conditions 14 13 EMC Tables 14 14 Technical Data 18 15 Manufacturer s Declaration 19 16 Manufacturer 19 ...

Страница 4: ...he standards and regulations in force The device must not be used in rooms with potential explosion hazard The device must not be immersed in liquids or sterilized with steam or by thermochemical methods All extraneous influences such as electromagnetic waves or high temperatures are to be kept to a minimum Avoid exerting force on the device or its accessories If the device is dropped damaged due ...

Страница 5: ...ns with protective earth The autopress may not be used if the housing is damaged or one of the front film layers becomes detached the device has been exposed to a hard physical shock e g dropped hit or shaken the device has been immersed in water the mains power cord or plug is damaged the device has given someone an electric shock the fixing clamp is damaged in such a way that safe clamping to th...

Страница 6: ...nation with all BIEGLER Blood and Infusionwarmers or used as standalone device Only the following single use pressure infusion bags can be used Description Article number BIEGLER Pressure Infusion Bag 500 ml JR2000500 BIEGLER Pressure Infusion Bag 1000 ml JR2001000 BIEGLER Pressure Infusion Bag 3000 ml JR2003000 2 2 SCOPE OF DELIVERY Quantity Description 1 autopress 2 BIEGLER Pressure Infusion Bag...

Страница 7: ...ltage 3 Before switching on the device place the infusion bag in an appropriate pressure infusion bag and then connect the infusion to the patient 4 Connect the pressure infusion bag to the Luer Connector of the autopress 5 Switch on the device by pressing the button in the upper right 6 Set the desired pressure with the arrow buttons and in steps of 10 mmHg 7 Start the pressure build up by pressi...

Страница 8: ...tion Display ON OFF activate right channel activate left channel decrease pressure increase pressure vent right channel vent left channel set pressure ratio actual to set pressure actual pressure clamp Power supplied Standby LED ...

Страница 9: ...CLEANING AND DISINFECTION Important Before cleaning or disinfecting the device must always be disconnected from the mains power supply by pulling the plug The device may only be cleaned using a soft cloth with a water soluble non aggressive cleaning agent or a special cleaning agent for plastics For the purposes of disinfection only ready made alcohol based spray disinfectants e g Meliseptol Foam ...

Страница 10: ...f the periodic inspection must be documented along with the date the inspecting agency and the device number Important If a malfunction is discovered during the periodic inspection suitable warning signs should be attached to the device to ensure that it is not used before the required service and repair work has been carried out 7 MANUFACTURER LIABILITY The manufacturer and the supplier of the de...

Страница 11: ...urer s warranty will be void if it is found that the maintenance disinfection and inspection instructions have not been followed according to the operating instructions the device has been damaged by force or operating error or has been used in any way contrary to the operating and safety instructions The warranty will also be void if original BIEGLER materials were not used as replacement parts o...

Страница 12: ...urning If the original packaging is no longer available the product has to be suitably packaged for the method of dispatch 10 DISPOSAL Dispose of the device at the end of its expected service life and its accessories in accordance with the applicable local regulations Do not dispose of this product as unsorted municipal waste ...

Страница 13: ...FF AC voltage activate right channel increase pressure activate left channel decrease pressure pause button vent the channel IPX4 Degree of protection against ingress of water splashing water Batch code Use by Latex free Humidity limitation Fragile handle with care Temperature limit Keep dry Protect from heat and radioactive sources Do not dispose of this product as unsorted municipal waste author...

Страница 14: ...r or the user of the autopress should ensure that it is used in such an environment Interference emission measurements Compliance Electromagnetic environment guidelines RF emissions acc to CISPR 11 Group 1 The autopress uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference to nearby electronic equipment RF emissions acc t...

Страница 15: ...common mode 1 kV differential mode 2 kV common mode The mains power supply quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations of the supply voltage acc to IEC 61000 4 11 5 UT 95 fall in UT for period 40 UT 60 fall in UT for 5 periods 70 UT 30 fall in UT for 25 periods 5 UT 95 fall in UT for 5 s 5 UT 95 fall in UT for perio...

Страница 16: ...Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affe...

Страница 17: ... output power of transmitter W Protection distance according to transmitter frequency m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 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 rated at a maximum output power not listed above the recommended distance can be determined using the equation applicable to the frequency of th...

Страница 18: ...I Degree of protection against electric shock Type CF defibrillationproof IP classification IEC 60529 IPX4 Classification 93 42 EEC IIa according to Rule 9 Operation mode continuous Pressure range 0 300 mmHg Accuracy of values displayed 5 of the measured value Dimensions 100 x 230 x 180 mm Weight device only 2 1 kg Applied part venous access not included Figure 3 Applied part depiction to patient ...

Страница 19: ...fined by Directive 93 42 EEC This is documented through the CE mark Notified Body TÜV SÜD Product Service Approval Number CE0123 16 MANUFACTURER Biegler GmbH Allhangstrasse 18a 3001 Mauerbach AUSTRIA Tel 43 1 979 21 05 Fax 43 1 979 21 05 16 office biegler com www biegler com ...

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