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protherm II 

 

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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 

 

13   SYMBOLS 

 

Certifies compliance with the Directive 93/42/EEC 

 

Observe the instructions for use 

 

Do not dispose of this product as unsorted municipal waste 

 

Control for increasing the temperature setting 

 

Control for decreasing the temperature setting 

 

Control for switching on / standby 

 

AC voltage

 

 

Serial number

 

IPX4 

Degree of protection against the ingress of splashing water 

 

Application part type B 

 

Manufacturer 

 

2015

 

Date of manufacture 

 

Protective earthing 

 

 

"Do not open while pressurised" 

 

see also Section 1 Warnings and safety instructions 

Summary of Contents for protherm II

Page 1: ...Instructions for use protherm II Blood and Infusion Warmer Edition 2017 11 21 220 240 V ENG...

Page 2: ...s 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 a...

Page 3: ...cedure 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 condition...

Page 4: ...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 acc...

Page 5: ...ed 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 r...

Page 6: ...y controlled heat zones The design of the casing allows rapid and simple fitting to any suitable infusion stand The plate temperature can be set between 37 C and 41 C in steps of 0 5 C and is displaye...

Page 7: ...for the air trap 3 Air trap 4 Attachment hooks for warming bag 5 Tube holder 6 Clips for closure of device 7 Tube holder 8 Tube holder Diag 2 1 Temperature scale 2 Temperature scale 3 Control to incr...

Page 8: ...d in Standby mode Heating of the protherm II can be started by pressing the control Diag 2 5 The protherm II attains the set target temperature within 1 minute The indicator display shows the actual t...

Page 9: ...The alarm can only be reset by pulling out the mains plug Wait for the temperature switch to cool down Visual signal Yellow alarm LEDs all green LEDs constantly on Yellow alarm LEDs all green LEDs con...

Page 10: ...alarm system does not have to be verified The alarm limits cannot be adjusted The risk management process has found that a shutdown of the alarms is not meaningful because it is desirable that the err...

Page 11: ...ion signal has been triggered The low temperature information signal is automatically cancelled after reaching 36 5 C Alarm LEDs light up audio alarm continuous tone Device was overheated Allow device...

Page 12: ...t such inspections based on their training knowledge and practical experience The results of the periodic inspection must be documented along with the date the inspecting agency and the device number...

Page 13: ...not triggered CHECKING THE HIGH TEMPERATURE ALARM Preheat the device to 41 C and wait for the temperature to stabilize then disconnect the mains plug Hold down the controls and and reconnect the main...

Page 14: ...within 24 months from the date of purchase will be repaired free of charge Claims are only accepted under the following terms The manufacturer and or supplier is informed immediately of the fault for...

Page 15: ...es assume liability for slight negligence The compensation for lost earnings and profits is likewise excluded 9 RETURN OF DEVICES Devices must be carefully cleaned and disinfected before being placed...

Page 16: ...guidance RF emissions acc to CISPR 11 Group 1 The protherm II uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nea...

Page 17: ...1000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interrupt...

Page 18: ...hs 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 m...

Page 19: ...to transmitter frequency m Rated maximum output power of transmitter W 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 12 0 04 0 07 0 1 0 37 0 11 0 22 1 1 17 0 35 0 70 10 3 69 1 11 2 21...

Page 20: ...pliance with the Directive 93 42 EEC Observe the instructions for use Do not dispose of this product as unsorted municipal waste Control for increasing the temperature setting Control for decreasing t...

Page 21: ...tion of the batch Expiration date One time use only 14 OPERATING AND STORAGE CONDITIONS Permissible environmental conditions for the device and accessories Transport and storage Operating Temperature...

Page 22: ...Over temperature switch off 43 0 C 43 5 C 45 C 3 C Audio alarm frequency 3600 Hz sound pressure level 71 dbA Low temp information signal 500 ms 1 s sound pressure level 71 dBA Lowest liquid temperatu...

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