Summary of Contents for Biegler autopress e
- Page 1 Instructions for use automatic pressure controller Version 2020-08-27 40-203-02...
- Page 2 IMPORTANT These directions are essential for operating the device. They must therefore be kept in a suitable place near the device, and should be kept with the device if it is given to other users. For proper and safe use of this device, it is essential 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.
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Page 3: Table Of Contents
Table of Contents 1. Warnings and Safety Instructions ............4 2. Description....................6 General Description................6 Scope of Delivery ................7 Intended use ..................7 Indication..................7 Contraindication ................7 3. Initial Operation ..................8 4. Maintenance..................10 5. Cleaning and Disinfection..............10 6. -
Page 4: Warnings And Safety Instructions
No mechanical or electrical changes may be made to the components of the device. Improper replacement of the lithium battery (other model) would result in an unacceptable risk. The lithium battery may only be replaced by BIEGLER or by authorized BIEGLER personnel. Replacement of the lithium accumulator by insufficiently trained personnel can... - Page 5 Only infusion bags that are capable of 300 mmHg must be used. Adhere to the instructions for use for this bags. The pressure infusion bags must be securely fastened at least 20 cm above the patient to prevent air embolism. Prevent the connecting hose from kinking. Always position the in such a way that it is easy to operate without obstacles.
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Page 6: Description
The automatic pressure controller is used when liquids are to be supplied under constant pressure. can be used in combination with all BIEGLER Blood- and Infusionwarmers or used as standalone device. The following single-use pressure infusion bags can be used:... -
Page 7: Scope Of Delivery
Scope of Delivery Quantity Description Pressure Infusion Bag 500 ml Instruction for use Intended use The automatic pressure controller is designed for use in IV infusion therapy and for applications where IV infusions or irrigations are to be supplied under constant pressure. Indication The automatic pressure controller can be used wherever liquids are... -
Page 8: Initial Operation
Initial Operation Observe the instructions for use! Handling of this device requires knowledge and adherence to these instructions. The autopress e and accessories may only be used by physicians, physician assistants or other qualified specialized staff. The condition of the patient has to be monitored during the application. - Page 9 Operation: ON / Standby clamp channel vented (symbol disappears set pressure when channel is activated) ratio actual to set battery indicator pressure power supplied actual pressure Standby-LED increase vent left pressure channel vent right activate left channel channel activate right channel decrease pressure...
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Page 10: Maintenance
Maintenance was largely designed as a maintenance-free device. For long- term maintenance of quality and functional safety, we would like to ask you to observe the following points: Always keep the device clean (see the "Cleaning and disinfection" section). Periodic technical safety inspections must be carried out as described in the "Periodic inspections"... -
Page 11: Manufacturer Liability
The results of 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. -
Page 12: Warranty Conditions
The warranty will also be void if original BIEGLER materials were not used as replacement parts, or measures for repair were undertaken by persons not authorized by the manufacturer or supplier. -
Page 13: Return Of Devices
Return of Devices Devices must be carefully cleaned and disinfected before being placed in the original packaging for returning. 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 or its accessories in accordance with local regulations. -
Page 14: Symbols
11. Symbols Compliance with Directive Serial number 93/42/EEC Consult instructions for use Manufacturer Attention Manufacturing date Defibrillation-proof type CF applied part ON / Standby AC voltage Increase pressure Activate right channel Activate left channel Decrease pressure Degree of protection Pause button – IPX4 against ingress of water - vent the channel... -
Page 15: Operating And Storage Conditions
12. Operating and Storage Conditions Permissible environmental conditions transporting storing the and accessories: Transport and storage Operating Temperature 10 – 40 °C 10 – 30 °C Relative humidity 30 – 75 % 30 – 75 % Ambient pressure 700 – 1060 hPa 700 –... - Page 16 385 MHz; Pulse Modulation: 18 Hz; 27 V/m 450 MHz, Pulse Modulation: 18 Hz: 1 kHz sine; 28 V/m 710, 745, 780 MHz; Pulse Modulation: 217 Hz; 9 V/m Proximity fields form RF wireless 810, 870, 930 MHz; communications Pulse Modulation: 18 Hz; 28 V/m equipment (IEC 61000-4-3) 1720, 1845, 1970 MHz;...
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Page 17: Technical Data
14. Technical Data Device: automatic pressure controller Type designation: Operating voltage: 100 – 240 V / 50 – 60 Hz Power consumption: max. 36 VA Supply type: mains or battery operation Protection class: Degree of protection against electric shock: Type CF, defibrillationproof IP-classification (IEC 60529): IPX4 Classification (93/42/EEC):... -
Page 18: Manufacturer's Declaration
Directive 93/42/EEC. This is documented through the CE mark. Notified Body: TÜV SÜD Product Service GmbH, 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 email: office@biegler.com...
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