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Summary of Contents for Biegler protherm II
- Page 1 Instructions for use protherm II Blood and Infusion Warmer Edition 2017-11-21 | 220 – 240 V...
- Page 2 II 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
II Table of contents Warnings and safety instructions .............. 4 Description ....................6 General Description ........................6 Scope of delivery ........................6 Consumable material......................... 6 Initial operation ................... 7 Setting up procedure ......................... 7 Alarms ............................9 Shutting down the device ......................10 Troubleshooting ........................ -
Page 4: Warnings And Safety Instructions
If the device is dropped, damaged due to force, or functions in a way other than described in the operating instructions, stop using the device immediately and return it to the service center. Persons and services authorized by BIEGLER must carry out repairs and modifications on the device. - Page 5 The device may not be set up and operated in direct proximity to devices which generate high levels of excess heat. Only sterile BIEGLER consumable materials may be used in conjunction with the protherm II. Safety Instructions for consumable materials: ...
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Page 6: Description
DESCRIPTION GENERAL DESCRIPTION The BIEGLER protherm II is a warmer for infusions and transfusions at high flow rates. The device operates on the basis of the dry heat principle and uses warming plates heated on both sides. The medium is heated rapidly, efficiently and gently by using three independently controlled heat zones. -
Page 7: Initial Operation
II INITIAL OPERATION SETTING UP PROCEDURE Diag. 1 1 Entry of liquid 5 Tube holder 2 Mounting for the air trap 6 Clips for closure of device 3 Air trap 7 Tube holder 4 Attachment hooks for warming bag 8 Tube holder Diag. - Page 8 (Diag.1/3). The warming bag hangs without creases in the open device. Close the protherm II and lock with the clips on the right side (Diag.1/6). Place the air trap in the mounting provided (Diag.1/2).
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Page 9: Alarms
II ALARMS The protherm II can trigger two types of temperature alarm: Software high temperature alarm Hardware high temperature alarm Condition The high temperature alarm is If the temperature rises above 45 °C triggered when the temperature of due to a software error, at 46 °C ±... -
Page 10: Shutting Down The Device
II The low temperature alarm is activated when the average temperature from the three zones fall below 36.5 °C. The audio low temperature alarm is deactivated during the first 60 seconds after switching on. The high temperature alarm is activated when the temperature of one of the six heating plates exceeds 43.0 °C. -
Page 11: Troubleshooting
→ return device for servicing MAINTAINANCE The protherm II is designed as a low-maintenance device. For long-term maintenance of quality and functional safety, the following points have to be observed: Always keep the device clean (see the "Cleaning and disinfection" section). -
Page 12: Cleaning And Disinfection
CHECKING THE WARM-UP PERIOD This is the time taken by the protherm II to heat up to 38.5 °C from room temperature. If this time is much more than one minute, there is a malfunction. CHECKING THE CONTROL TEMPERATURE The control temperature is checked on the lower third of the rear heating plates, about 7 cm from the right-hand edge of the device. - Page 13 The protherm II now slowly cools down. When the temperature drops below the 36.5 °C threshold, the low temperature alarm should be active.
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Page 14: Manufacturer Liability
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... -
Page 15: Return Of Devices
II If the manufacturer is required to meet a warranty claim in accordance with these terms, the customer shall bear the costs and risks of transport of the device from and to the place of use. The manufacturer and/or supplier shall under no circumstances assume liability for slight negligence. -
Page 16: Electromagnetic Compliance
Table 201 Guidance and manufacturer´s declaration – electromagnetic emission The protherm II is intended for use in the electromagnetic environment specified below. The customer or the user of the protherm II should assure that it is used in such an environment. - Page 17 Guidelines and manufacturer´s declaration – electromagnetic interference resistance The protherm II is intended for use in the electro-magnetic environment specified below. The customer or the user of the protherm II should assure that it is used in such an environment...
- Page 18 To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the protherm II is used exceeds the applicable RF compliance level above, the protherm II should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the protherm II.
- Page 19 RF telecommunications devices and the protherm II The protherm II is intended for use in an electro-magnetic environment in which radiated RF disturbances are controlled. The customer or the user of the protherm II can help prevent...
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Page 20: Manufacturer's Declaration
II 12 MANUFACTURER'S DECLARATION The blood and infusion warmer protherm II as well as BIEGLER consumables (Heating bags) are medical products as defined by Directive 93/42/EEC. This is documented through the CE mark. Notified Body: TÜV SÜD Product Service, Approval Number CE0123... -
Page 21: Operating And Storage Conditions
II Protect from heat and radioactive Humidity limitation sources Temperature limit Keep dry Fragile, handle with Catalogue number care Symbols for consumables Sterile by ethylene oxide Designation of the batch Expiration date One-time use only 14 OPERATING AND STORAGE CONDITIONS... -
Page 22: Technical Data
II 15 TECHNICAL DATA Device: Blood and Infusion Warmer Type designation: protherm II Voltage: 220 - 240 V / 50 Hz Power consumption: 1400 W Protection class: Degree of protection: Type B Degree of prot. against ingress: IPX4 Fuses: primary 2x T 6.3 AL 250 V...
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