background image

 

protherm II

 

 

17

 

Table 202  

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

Interference 

resistance test 

IEC 60601

 

test level 

Compliance level 

Electromagnetic environment-

guideline 

Electrostatic

 

discharge

 

IEC 61000-4-2 

± 6 kV contact 

± 8 kV air 

 

± 6 kV contact 

± 8 kV air 

Floors should be wood, concrete or 
ceramic tile. If floors are covered 
with synthetic material, the relative 
humidity should be at least 30 %. 

Fast transient 
/electrical bursts 
acc. to IEC 61000-4-4 

± 2 kV for power 
supply lines

 

± 1 kV for input/output

 

lines 

± 2 kV for power 
supply lines 

not applicable 

Mains power quality should be that 
of a typical commercial or hospital

 

environment. 

Surges as per

 

IEC 61000-4-5 

±  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 
interruptions 

 

and voltage variations 
of the supply voltage 

 

acc. to IEC 61000-4-
11 

 

 

 

 

 

<

 5 % UT 

 

(>95 % dip in UT )

 

for 0.5 cycle

 

 

40 % UT 

 

(60 % dip in UT )

 

for 5 cycles

 

 

 70 % UT 

 

(30 % dip in UT )

 

for 25 cycles

 

 

<

 5 % UT 

 

(>95 % dip in UT )

 

for 5 sec  

<

 5 % UT 

 

(>95 % dip in UT )

 

for 0.5 cycle

 

 

40 % UT 

 

(60 % dip in UT )

 

for 5 cycles

 

 

 70 % UT 

 

(30 % dip in UT )

 

for 25 cycles

 

 

<

 5 % UT 

 

(>95 % dip in UT )

 

for 5 sec 

 

 

Mains power quality should be that 
of a typical   commercial or hospital 
environment. If the user of the 
protherm II requires continued 
operation during power mains 
interruptions, it is recommended 
that the protherm II be powered 
from an uninterruptible power 
supply or a battery. 

 

Power frequency

 

(50/60 Hz)

 

magnetic field

 

IEC 61000-4-8 

 

3 A/m 

 

 

3 A/m 

 

Power frequency magnetic fields 
should be at levels characteristic of 
a typical location in a typical 
commercial or hospital 
environment. 

NOTE                 U

T

 is the AC mains voltage prior to application of the test level. 

 

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...

Reviews: