Biegler protherm II User manual

Instructions for use
protherm II
Blood and Infusion Warmer
Edition 2017-11-21 | 220 – 240 V
ENG

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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.
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 be attached to the device
to ensure that it is not used before the required service and repair work
has been carried out.

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Table of contents

1 Warnings and safety instructions .............................................................. 4
2 Description .................................................................................................. 6
2.1 General Description ................................................................................................................... 6
2.2 Scope of delivery ....................................................................................................................... 6
2.3 Consumable material................................................................................................................. 6
3 Initial operation ........................................................................................... 7
3.1 Setting up procedure ................................................................................................................. 7
3.2 Alarms ....................................................................................................................................... 9
3.3 Shutting down the device ........................................................................................................ 10
3.4 Troubleshooting ....................................................................................................................... 11
4 Maintainance ............................................................................................. 11
5 Cleaning and disinfection......................................................................... 12
6 Periodic inspections ................................................................................. 12
7 Manufacturer liability ................................................................................ 14
8 Warranty conditions ................................................................................. 14
9 Return of devices ...................................................................................... 15
10 Disposal ..................................................................................................... 15
11 Electromagnetic compliance.................................................................... 16
12 Manufacturer's declaration ...................................................................... 20
13 Symbols ..................................................................................................... 20
14 Operating and storage conditions ........................................................... 21
15 Technical Data ........................................................................................... 22
16 Manufacturer ............................................................................................. 22

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1 WARNINGS AND SAFETY INSTRUCTIONS
 In the event of any suspected malfunction while in operation, the device should be
immediately removed from service and not used for infusions or transfusions until
appropriate investigations have demonstrated that there has been no impairment.
 Unplugging the mains plug is the only safe way to disconnect from the mains
power supply. Place the device so that it can easily be disconnected from the
mains.
 If the high temperature alarm is triggered the supply of liquid to the patient must be
immediately stopped by disconnecting the connection tube to the patient. The
medium being used in the device must no longer be administered to the patient.
 The system must be depressurized before opening the device by switching off
the pressure cuffs or infusion pump and releasing the pressure remaining within
the system. Closing the system forcibly when the warming bags are full and
under pressure may cause the warming bag to burst. The maximum pressure of
the system must not exceed 300 mmHg.
 The device may only be fastened to infusion stands or tripods which have
sufficient stability and load capacity to support the device.
 The device must only be used in areas in which the electrical installations are in
accordance with the standards and regulations in force. To prevent the risk of an
electric shock the device shall only be connected to a supply network with
protective earth connection.
 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.
 The device can be influenced by other devices or equipment nearby or it can
influence them. It is subject to special precautions regarding electromagnetic
compatibility (EMC). Portable and mobile RF communication equipment can
affect medical electrical equipment.
 Avoid exerting force to the device or its accessories.
 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.

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 Periodic technical safety inspections must be carried out as described in the
"Periodic inspections" section.
 No mechanical or electrical modifications may be made to the components of the
warming system.
 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:
 The consumable materials are intended for single use only.
 Only sterile consumables or material specified by BIEGLER or approved by
BIEGLER for use with this device may be used in conjunction with the
protherm II.
 Only use items with intact individual packaging.
 Consumables are only for one-time use (disposable).
The reuse of disposable products results in possible infection risks for the patient
or user. Product contamination may lead to health problems, diseases or death
of the patient.
 Do not re-sterilize!
The protherm II may not be used if:
 the case 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 device has triggered a high temperature alarm that was not caused by
external factors.
 the mains power cord or plug is damaged.
 the device has given somebody an electric shock.
 the fixing clamp is damaged in such a way that safe clamping to the infusion
stand is no longer guaranteed.