STIHLER ELECTRONIC AFP300 Instructions For Use Manual Download Page 2

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Serial number

Registration number

Device location

Start-up date

Manufacturer: STIHLER ELECTRONIC GmbH

Julius-Hoelder-Strasse 36
70597 Stuttgart
GERMANY
Tel. +49 (0) 711-720670
Fax +49 (0) 711-7206757
www.stihlerelectronic.de
E-Mail: [email protected]

STIHLER ELECTRONIC GmbH, Stuttgart, declares in sole responsibility that this
product (230

– 240 VAC models only) conforms to EC Directive 93/42/EEC on

medical devices.
Notified body: DEKRA Certification GmbH, registration number 0124.

Summary of Contents for AFP300

Page 1: ...Instructions for use Warmer for Blood Intravenous Fluids and Irrigation Fluids REF AFP300 REF AFP302 STIHLER ELECTRONIC GmbH 70597 Stuttgart Germany Part No 10038 12 Rev 05 10 2017...

Page 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...

Page 3: ...USER PROFILE 13 4 7 INTENDED USE OPERATION ENVIRONMENT 13 4 8 INTENDED PART OF THE BODY TYPE OF TISSUE 13 5 Symbols 14 6 Product description 16 6 1 INTRODUCTION 16 6 2 TECHNICAL DESCRIPTION 16 6 3 COM...

Page 4: ...N MODE FAILURE 42 11 Brief overview of operating states and alarms 43 11 1 OVERVIEW OF OPERATION STATES 43 11 2 OVERVIEW OF ALARMS 44 12 Maintenance 45 12 1 RECURRENT TESTS 45 12 2 SET UP FOR ELECTRIC...

Page 5: ...ct 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 con...

Page 6: ...ling the precise reasons circumstances 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...

Page 7: ...risk of explosion or in the presence of flammable anesthetics 3 2 Warnings WARNING Risk of injury Use of the ASTOFLO PLUS ECO must be carried out under the supervision of a physician Read and observe...

Page 8: ...vice from service immediately In the event of an overheating alarm proceed as outlined below 1 Ensure that the ASTOFLO PLUS ECO safety system has deactivated the heating function and that the temperat...

Page 9: ...fect ants the area near the temperature sensors the last 40 cm of the free end of the heating profile WARNING Risk of haemolysis Make sure that the infusion line is not kinked WARNING Risk of air embo...

Page 10: ...LO PLUS ECO control unit and the heating profile are undamaged The mains plug must be removed from the socket to fully disconnect the ASTOFLO PLUS ECO from the mains WARNING Risk of radio interference...

Page 11: ...essively Do not use any clamps or sharp instruments on the heating profile as damage to the profile or the infusion line inside may result Use narrow plaster strips or other narrow soft fixation metho...

Page 12: ...such as reorienting or relocating of ASTOFLO PLUS ECO or shielding 3 4 Notices NOTICE To avoid damage to the warmer Do not immerse the control unit or the heating profile in liquid Do not disinfect th...

Page 13: ...hooks 4 5 Intended patient population There are no restrictions for the intended patient group 4 6 Intended user profile The ASTOFLO PLUS ECO Warmer is to be operated only by medically qualified and...

Page 14: ...y is changed three steps Test button Starts safety tests Temperature setting range is limited Where applicable these symbols appear at the appropriate location on the warmer on the packaging on the id...

Page 15: ...S ECO Warmer Disposable parts e g infusion sets suitable for use with this device have their own approvals 75JA MEDICAL GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONL...

Page 16: ...6 2 Technical description During operation of the Warmer heat is transferred from the internal heating wire to the heating profile Commercially available infusion sets can simply be inserted in the f...

Page 17: ...e temperature control of the ASTOFLO PLUS ECO controls and monitors the temperature of the heating profile but not the patient s body temperature If the ASTOFLO PLUS ECO cannot be started or if the pa...

Page 18: ...e 6 Product description 18 Fig 2 WP31 outlet fluid temperatures at 20 C inlet temperature set temperature 43 C and different infusion sets Fig 3 WP31 outlet fluid temperature at Set temperature 43 C d...

Page 19: ...cators chapter 6 4 Control panel 3 Flexible Heating Profile changeable Transfers heat from the internal heating wire to the medium to be warmed via the inserted infusion line 4 Power Supply Cord with...

Page 20: ...tion The purpose of additional potential equalization is to equalize potentials between different metal parts that can be touched simultaneously or to reduce differences of potential which can occur d...

Page 21: ...and all LEDs flash and the acoustic alarm beeps once to confirm that the control unit works properly Set temperature is flashing for about 3 seconds Current temperature of the heating profile is displ...

Page 22: ...particular test when the device is in Test Mode Press to select the brightness of the display after pressing Test button and Set button together 7 Display Informs the user about temperatures test and...

Page 23: ...the device from any Mode to Standby Mode Device response The display turns off The Start LED turns off The Alarm LED turns off The Standby LED turns on when the device is switched to Standby Mode Aft...

Page 24: ...splay and all LEDs flash and the acoustic alarm signal beeps once to indicate that the control unit is functioning correctly The Start LED flashes and the display indicates the set temperature flashin...

Page 25: ...e function of the cut offs The temperature regulation is activated The display shows the current temperature e g 37 8 C of the heating profile If the current temperature is below 18 C the display indi...

Page 26: ...election has been made the display will continue to flash this set temperature for approximately 3 seconds then revert to current temperature After changing the set temperature the acoustic alarm beep...

Page 27: ...ned on On Mode or started Heating Mode The display indicates 2 Then press the Set button within 2 seconds once or several times to select the brightness of the display Device responce The brightness o...

Page 28: ...he 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...

Page 29: ...e the ASTOFLO PLUS ECO until the appropriate corrective measures have been taken Damaged or worn cables plugs or connecting socket Damaged housing damaged or loose control panel Control unit has been...

Page 30: ...All segments of the display and all LEDs flash and the acoustic alarm signal beeps once to indicate that the control unit is functioning correctly The Start LED flashes and the temperature display sh...

Page 31: ...ons of the complete fluid stream are fixed tightly to prevent fluid leakages and inadvertent infusion of air into the fluid stream Do not warm infusions containing soluted gas e g bicarbonate Extreme...

Page 32: ...n line at the free end of the heating profile about 3 cm to 5 cm behind the luer locks connection Fig 8 A of the infusion set 3 With the thumb insert the infusion line into the groove heating profile...

Page 33: ...or roll the heating profile Do not place the heating profile under or directly beside the patient Heat build up can occur and or the infusion line can be squeezed off Do not cool or expose to cool tem...

Page 34: ...products Steam autoclave Hot air Thermo chemical cleaning solutions Refer to the specific instructions for use of the disinfectants CAUTION Risk of injury Damage to the heating profile can cause over...

Page 35: ...sinfectants based on alcohol with a low content of aldehyds 0 2 Do not disinfect the heating profile with disinfectants containing hypochlorite bleach In doing so follow the contact time of the disinf...

Page 36: ...rator but must be inspected at regular intervals depending on the condition of the patient Then the intended operator s position is directly in front of the control panel In case of failure of the equ...

Page 37: ...p every 16 seconds The heating element is not switched off Alarm condition The current temperature of heating profile is longer than 10 minutes below the limit of the low temperature alarm during Heat...

Page 38: ...or Eliminate the heat source and or select cooler location Ambient temperature too high Eliminate heat source and or select cooler location The control unit or heating profile defective Return the con...

Page 39: ...s The heating element is switched off Alarm condition A defect of the cable break detection or a temperature sensor break has been detected Possible reason s Required action s Control unit and or heat...

Page 40: ...ure detected when the control unit is switched from Standby to On Mode or from On to Heating Mode or the Start button has been pressed to soon after switching to On Mode Possible reason s Required act...

Page 41: ...ds Alarm condition The heating profile is disconnected from the control unit in the Heating Mode or no heating profile is connected and the Start button is pressed in On Mode Possible reason s Require...

Page 42: ...g plate Control unit not plugged in 1 Plug the control unit into functioning socket 2 Press the Standby button 3 Press the Start button to switch the control unit to Heating Mode Control unit is defec...

Page 43: ...n states Operating state Display Standby LED blue Start LED green Alarm LED yellow Acoustic alarm signal Possible reason s Standby Mode On Mode No heating profile connected T 18 0 C T 48 0 C Heating M...

Page 44: ...file for longer than 10 minutes T TSet 3 C Excessive Temperature Alarm Alternating with T Beeps every 16 s T 43 6 C Cable Break Alarm Beeps every 16 s Cable break of heating profile temperature sensor...

Page 45: ...rating or maintenance personnel On request STIHLER ELECTRONIC GmbH will provide service instructions that will allow properly trained and qualified persons to repair the parts of the equipment that th...

Page 46: ...tests Result The test is successful when the limits are met in accordance with the test protocol Test 3 1 Optional to test 3 2 Earth leakage current direct method Required Actions Measure the maximum...

Page 47: ...he heating profile is not taken into account To do so the heating profile would have to be immersed in saline solution or covered with aluminum foil Test 4 2 Optional to test 4 1 Applied part leakage...

Page 48: ...0 C to 44 2 C All individual tests are E11 E12 successful The test is not successful if any of the following conditions occurs The Start LED does not flash The Alarm LED does not turn on The acoustic...

Page 49: ...ing profile must be carried out at least every 12 months Test 7 Visual inspection Required actions 1 Clean the heating profile with an alcohol based agent 2 Dust the heating profile groove and outer s...

Page 50: ...re After that the measurements can be carried out Uneven temperature distribution because of opened windows or doors incoming sunrays or other heat sources like heater fans disable this measurement If...

Page 51: ...k of the essential performance Required actions 1 Connect the heating profile to the control unit 2 Press the Standby button to switch the warmer on 3 Press the Set button to select 43 C as set temper...

Page 52: ...ethod Connection 1 and 2 and possibly 3 depending on the used safety analyzer 4 1 Optional to 4 2 Applied part leakage current N C Connection 1 and 2 Applied part leakage current S F C PE open Applied...

Page 53: ...open Measure all combinations of line polarity Min mA Value mA Max mA P F Earth leakage current N C 0 5 Earth leakage current S F C N open 0 010 1 0 Test 3 2 Equipment leakage current alternative meth...

Page 54: ...P F Temperature sensor 1 T1 Temperature sensor 2 T2 Temperature thermometer TT Difference TT to T1 1 2 Difference TT to T2 1 2 Difference T1 to T2 1 2 Test 9 Heating up test Min Value Max P F Heating...

Page 55: ...unclassified Dimensions excl heating profile Height Width Depth incl attachment device max 280 mm 120 mm 175 mm Weight excl heating profile 3 kg Operating mode continuous operation Permissible enviro...

Page 56: ...nd essential performance Collateral standard Electromagnetic compatibility Requirements and tests IEC EN 60601 1 6 Medical electrical equipment Part 1 6 General requirements for basic safety and essen...

Page 57: ...le connection cable heating profile 80cm xx EU 230 VAC Schuko Plug CH 230 VAC Swiss Plug DK 230 VAC Denmark Plug CN 230 VAC Chinese Plug UK 240 VAC BS Plug incl 13A fuse AU 240 VAC Australian Plug NA...

Page 58: ...ified below The customer or user of the ASTOFLO PLUS ECO should assure that it is used in such an environment Immunity test Test level Compliance level Electromagnetic environment guidance Electrostat...

Page 59: ...ed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ASTOFLO PLUS ECO is used exceeds the applicable RF compliance level a...

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