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ASTOTHERM PLUS Instructions for Use

14 Compliance with international standards

48

14 Compliance with international standards

Standard

Title

IEC/EN 60601-1
ANSI/AAMI ES 60601-1
CAN/CSA C22.2 No.
60601-1

Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance

IEC/EN 60601-1-2

Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance -
Collateral standard: Electromagnetic compatibility

–

Requirements and tests

IEC/EN 60601-1-8

Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential performance
- Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical
equipment and medical electrical systems.

ASTM F 2172-02

Standard Specification for Blood/Intravenous
Fluid/Irrigation Fluid Warmers

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Содержание ASTOTHERM plus

Страница 1: ...Instructions for use ASTOTHERM plus Warmer for Blood Intravenous Fluids and Irrigation Fluids REF AP220 STIHLER ELECTRONIC GmbH 70597 Stuttgart Germany Order No 0550 7200 12 Rev 06 10 2017 10 2013...

Страница 2: ...gart GERMANY Tel 49 0 711 720670 Fax 49 0 711 7206757 www stihlerelectronic de E Mail info stihlerelectronic de 2017 STIHLER ELECTRONIC GmbH STIHLER ELECTRONIC GmbH Stuttgart declares in sole responsi...

Страница 3: ...of tissue 12 5 Symbols 13 6 Product description 15 6 1 Introduction 15 6 2 Technical description 15 6 3 Components of the ASTOTHERM PLUS 17 6 4 Control panel 18 7 Operating states 19 7 1 Standby mode...

Страница 4: ...nance 38 12 1 Recurrent tests 39 12 2 Set up for electrical tests 44 12 3 Test protocol 45 13 Technical data 47 14 Compliance with international standards 48 15 Ordering information accessories and co...

Страница 5: ...handling use of force or damage caused by normal wear and tear This applies also to changes undertaken by persons who are not authorised by the manufacturer and to modifications to the original condi...

Страница 6: ...mstances and if known the cause of the return To prevent transportation damage the equipment should be shipped either in the original packaging or in other well protected packaging WARNING Risk of inf...

Страница 7: ...sk of explosion or in the presence of flammable anesthetics 3 2 Warnings WARNING Risk of injury Use of the ASTOTHERM PLUS must be carried out under the supervision of a physician Read and observe all...

Страница 8: ...roceed as outlined below 1 Ensure that the ASTOTHERM PLUS safety system has deactivated the heating function and that the temperature is dropping below 43 C If the temperature is not dropping stop the...

Страница 9: ...rocedures Clean and disinfect the warmer after every use and before you return the warmer for repairs WARNING Risk of electric shock To avoid the risk of electric shock this equipment must only be con...

Страница 10: ...s CAUTION Risk of injury Federal law USA restricts this device to sale by or on the order of a physician When fixing the warmer to a mounting device pay attention to the max load to avoid tilting Usin...

Страница 11: ...and put into service according the EMC information provided This device system may cause radio interference or may disrupt the operat ion of nearby devices It may be necessary to take mitigation measu...

Страница 12: ...patient population There are no restrictions for the intended patient group 4 6 Intended user profile The ASTOTHERM PLUS Warmer is to be operated only by medically qualified and trained healthcare pro...

Страница 13: ...cordance with IEC EN 60601 1 IPX 4 Splash proof in accordance to IEC EN 60529 Refer to instructions for use Follow instructions for use Caution Federal US law restricts this device to sale by or on or...

Страница 14: ...temperature range within which the package must be stored and handled Indicates the ambient humidity range within which the package must be stored and handled Indicates the pressure range within the p...

Страница 15: ...of the Warmer heat is transferred from the internal heating element to the heat exchanger Infusion extensions can simply be inserted in the circumferential groove The heat from the heat exchanger is t...

Страница 16: ...emperature If the ASTOTHERM PLUS cannot be started or if the patient s temperature balance is insufficient consider the use of alternative warming methods in order to avoid or reduce hypothermia or to...

Страница 17: ...ated 3 Screw with Star Grip For adapting the attachment device to infusion stands of different diameters 4 Universal Attachment Device Attaches the warmer to infusion stands 12 to 35 mm or medical rai...

Страница 18: ...ts when the warmer is operated with the middle setpoint temperature 5 Start LED Flashes green when the device is in On Mode heating is not yet started Illuminates green when the device is in Heating M...

Страница 19: ...actions of the user and the device responses of each operating state 7 Operating states 7 1 Standby mode Control Panel Action When the mains cable is plugged into the socket the device is in Standby M...

Страница 20: ...LED turns off On LED turns on The backlight of the display lights up The display shows the current temperature eg 22 4 C of the heat exchanger and the available range of setpoint temperatures The sel...

Страница 21: ...nt temperature indicated by the frame is reached The display shows the increasing current temperature of the heat exchanger e g 39 4 C Alarm LED lights until the setpoint temperature has exceeded duri...

Страница 22: ...shes green until to the confirmation with the Start button After confirmation the Start LED lights green and the frame marks the currently selected setpoint temperature The displayed actual temperatur...

Страница 23: ...warmer is equipped with a universal attachment device With this the device can be securely attached to infusion stands as well as to medical standard rails 8 2 1 Attachment to infusion stands rods 1 T...

Страница 24: ...Damaged or worn cables or plugs Damaged housing damaged or loose control panel Device has been exposed to mechanical impact exposed to severe shock or exposed to liquid Alarm without knowing the caus...

Страница 25: ...if necessary 6 Press the Start button for at least one second to switch ASTOTHERM PLUS to Heating Mode While the button is pressed the clicking of the self test can be heard The Start LED illuminates...

Страница 26: ...ot pass to the patient WARNING Risk of infection Use aseptic procedures WARNING Risk of haemolysis Make sure that the infusion line is not kinked CAUTION Risk of hypothermia When ASTOTHERM PLUS is use...

Страница 27: ...sion 3 After leaving the last circulation clip the infusion extension into the front tube holder fig 4 C 4 Check the correct position of the infusion extension a Infusion extension is fully in the gro...

Страница 28: ...by button for one second to switch off ASTOTHERM PLUS All indicators turn off the LED Standby turns on blue To disconnect ASTOTHERM PLUS from the mains it is necessary to completely pull out the plug...

Страница 29: ...rfaces with a soft cloth cotton swab and mild soap and water solution 3 Disinfect ASTOTHERM PLUS with either An approved disinfectant An alcohol based disinfectant with a low content of aldehydes 0 2...

Страница 30: ...t it must be checked at regular intervals depending on the condition of the patient status Then the intended operator s position is directly in front of the control panel In case of failure of the equ...

Страница 31: ...Alarm condition The current temperature of the heat exchanger is more than 4 C below the setpoint temperature during Heating Mode Possible reason s Required action s Inlet temperature of the liquid is...

Страница 32: ...ffect of external heat source such as sunlight or radiator Eliminate the heat source and or select cooler location Ambient temperature too high Eliminate heat source and or select cooler location Warm...

Страница 33: ...The Alarm LED lights yellow The acoustic alarm signal sounds every 17 seconds The heating element is switched off Alarm condition A defect of the cable break detection or a temperature sensor break h...

Страница 34: ...can cause a device reaction Alarm condition Program fault Possible reason s Required action s Temporary program fault Alarm reset see below Permanent program fault caused by defect data file Return A...

Страница 35: ...by pressing the Standby button Possible reason s Required action s Power supply problem or no power Check plugs and fuses compare mains voltage with rating plate Warmer not plugged in 1 Plug the warm...

Страница 36: ...On LED Acoustic alarm signal Possible reason s blue yellow green green Standby Mode OFF On Mode TAct 15 C or TAct 50 C TAct Heating Mode TAct 15 C TAct TAct Start button has been pressed too short Oth...

Страница 37: ...ssociated circuit s interrupted Processor Alarm OFF Program failure Manual Excessive Temperature Alarm Test 1 alternating with Tact Start button has been pressed for longer than 3 seconds Manual Exces...

Страница 38: ...l sales point Any repairs such as but not limited to changing the power supply cord to the equipment may only be carried out by persons authorised and qualified by the manufacturer Modifications to th...

Страница 39: ...he housing Control panel in good condition Since the front foil prevents fluid from entering the unit it is important that its full surface adheres securely to the housing No defects in the power supp...

Страница 40: ...ccessful when the limits are met in accordance with the test protocol or alternatively Test 4 2 Optional to test 4 1 Earth leakage current direct method Required Actions Measure the maximum earth leak...

Страница 41: ...mperature of the heat exchanger 8 Compare the measured temperature with the displayed temperature and the selected setpoint temperature of the Warmer Result The test is successful when the limits are...

Страница 42: ...c alarm does not beep For the continuation of the tests press the Start button to switch the Warmer back to the Heating Mode Test 7 Manual excessive temperature cut off 2 Required Actions 1 Operate th...

Страница 43: ...tual temperature slowly decreases and after cooling to TAct TSet 4 C the Alarm LED flashes yellow and after another 2 minutes the acoustic alarm signal sounds The test is not successful if any of the...

Страница 44: ...sibly connection 2 depending on the used safety analyzer 4 2 optional to 4 1 Earth leakage current N C direct method Connection 1 Earth leakage current S F C direct method N open Abb 7 Test set up for...

Страница 45: ...ce Value M Min M P F Insulation resistance 100 Test 4 Leakage current test either to 4 1 or 4 2 4 1 Equipment leakage current alternative method Alternative test for measurement the earth leakage curr...

Страница 46: ...nual excessive temperature cut off 1 t1 Test 7 Manual excessive temperature cut off 2 t2 Test 8 Manual low temperature alarm t3 Overall assessment Please mark where applicable No safety or functional...

Страница 47: ...t device max 145 mm 135 mm 295 mm Weight 2 9 kg Operating mode continuous operation Permissible environmental conditions Humidity Temperature Pressure in operation 10 to 90 not condensing 16 C to 32 C...

Страница 48: ...cal electrical equipment Part 1 2 General requirements for basic safety and essential performance Collateral standard Electromagnetic compatibility Requirements and tests IEC EN 60601 1 8 Medical elec...

Страница 49: ...sion line 230 240 VAC Australian Plug AP220EU For 4 mm infusion line 230 240 VAC CEE 7 7 Schuko Plug AP220NA For 4 mm infusion line 100 115 VAC Hospital Grade Plug AP220UK For 4 mm infusion line 230 2...

Страница 50: ...below The customer or user of the ASTOTHERM PLUS should assure that it is used in such an environment Immunity test Test level Compliance level Electromagnetic environment guidance Electrostatic disc...

Страница 51: ...fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ASTOTHERM PLUS is used exceeds the applicable RF compliance level...

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