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STIHLER ELECTRONIC ASTOTHERM plus Instructions For Use Manual

Warmer for blood, intravenous fluids and irrigation fluids
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ASTOTHERM
STIHLER ELECTRONIC GmbH • 70771 Leinfelden - Echterdingen • Germany
Warmer for Blood, Intravenous
Fluids and Irrigation Fluids
Instructions for use
®
plus
REF
REF
REF
REF
AP220
AP220S
AP260
AP260S

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  • Page 1 Instructions for use ® plus ASTOTHERM Warmer for Blood, Intravenous Fluids and Irrigation Fluids AP220 AP220S AP260 AP260S STIHLER ELECTRONIC GmbH • 70771 Leinfelden - Echterdingen • Germany...
  • Page 2 To be filled in by the user: Serial number Registration number Device location Start-up date Manufacturer: STIHLER ELECTRONIC GmbH Gaussstrasse 4 70771 Leinfelden - Echterdingen GERMANY Tel. +49 (0) 711-720670 Fax +49 (0) 711-7206757 www.stihlerelectronic.de E-Mail: info@stihlerelectronic.de © 2020 STIHLER ELECTRONIC GmbH...

  • Page 3: Table Of Contents

    5 Symbols ......................... 15 6 Product description ....................... 17 6.1 Introduction ........................ 17 6.2 Technical description ....................17 6.3 Components of the ASTOTHERM PLUS ..............21 6.4 Applied part ASTOLINE ..................... 22 6.5 Control panel ......................23 7 Operating states ......................25 7.1 Standby mode ......................
  • Page 4 10 Alarms and troubleshooting ..................41 10.1 Low temperature alarm .................... 42 10.2 Overheating alarm ....................43 10.3 Cable break alarm ....................44 10.4 ASTOLINE alarm (“S” models only) ................. 45 10.5 Processor alarm....................... 46 10.6 Standby mode - failure ..................... 47 11 Brief overview of operating states and alarms ............

  • Page 5: Information About These Instructions

    If the equipment is damaged during the guarantee period, send the cleaned equipment to the nearest sales point or directly to STIHLER ELECTRONIC GmbH. The sender is responsible for any transport and packaging costs.

  • Page 6: Disposal Of The Equipment

    Please follow the local rules for the disposal of used products, or send the cleaned and disinfected equipment with a corresponding note to STIHLER ELECTRONIC GmbH or your closest sales point. This will ensure the most cost efficient and proper disposal of your old equipment.

  • Page 7: Important Safety Information

    NOTICE NOTICE indicates a property damage message. 3.1 Dangers DANGER Risk of explosion! Do not use the ASTOTHERM PLUS in an environment at risk 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.
  • Page 8 • The service personnel must be appropriately trained and qualified. • Do not use the ASTOTHERM PLUS until the following error conditions have been remedied through appropriate corrective action: - Damaged or worn cables, plugs, or connecting socket.
  • Page 9 3 Important safety information ASTOTHERM PLUS Instructions for Use WARNING Risk of overheating! • ASTOLINE („S“-models only) must hang freely while in use. Do not kink, cover (not even partially), clamp (for example, with a surgical clamp) or roll ASTOLINE.
  • Page 10 • All electrical installations must conform to the applicable electrical standards and the specifications defined by the manufacturer. • Before every use, check to make sure that the ASTOTHERM PLUS and the ASTOLINE are undamaged. • The mains plug must be removed from the socket to fully disconnect the ASTOTHERM PLUS from the mains.

  • Page 11: Cautions

    • 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 improve the patient's well-being.

  • Page 12: Notices

    • This device/system may cause radio interference or may disrupt the operat- ion of nearby devices. It may be necessary to take mitigation measures, such as re-orienting or relocating of ASTOTHERM PLUS or shielding the location. 3.4 Notices NOTICE •...

  • Page 13: Specification Of Application

    There are no known contraindications for warming blood, intravenous fluids and irrigation fluids. 4.4 Possible adverse effects When the ASTOTHERM PLUS is used as a warmer for return blood flow in a haemofiltration, haemodialysis or haemodiafiltration device, it must be ensured that the entire system meets the following: The highest set temperature (43°C) must be used with care when operating at low...

  • Page 14: Intended Part Of The Body/Type Of Tissue

    ASTOTHERM PLUS Instructions for Use 4 Specification of application 4.8 Intended part of the body/type of tissue The warmer is used to warm blood or other medical fluids supplied to the body. The fluids are physically separated from the warmer by disposable parts (tubes).

  • Page 15: Symbols

    5 Symbols ASTOTHERM PLUS Instructions for Use 5 Symbols Symbols, used on the Control Panel Alarm condition if the yellow “Alarm” LED lights “Standby” button. The Warmer is in Standby Mode if the blue LED is on “Start” button. The Warmer is in Heating Mode, if the green LED is on “Increase”...
  • Page 16 ASTOTHERM PLUS Instructions for Use 5 Symbols Symbol at the connector for potential equalization according IEC/EN 60601-1 Electrical devices are valuable products and should not be thrown in dustbin when the reach the end of their serviceable life. MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO...

  • Page 17: Product Description

    ASTOTHERM PLUS consists of a stand-alone Warmer and optionally of the additional active insulation ASTOLINE („S“-models). ASTOTHERM PLUS is a device for specific heating of blood and fluids which are delivered to the patients by transfusion, infusion or irrigation. The warming of the liquid supports the prevention and therapy of hypothermia during or after surgery;...
  • Page 18 • 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 improve the patient's well-being.
  • Page 19 6 Product description ASTOTHERM PLUS Instructions for Use Typical temperature curves are shown in the following figures. 10 ml/min = 0,6 l/h 60 ml/min = 3,6 l/h 20 ml/min = 1,2 l/h 70 ml/min = 4,2 l/h 30 ml/min = 1,8 l/h...
  • Page 20 ASTOTHERM PLUS Instructions for Use 6 Product description SET: 37°C 39°C 41°C 43°C Flow [ml/min] Fig. 3: Fluid outlet temperature (device outlet) at 20°C inlet temperature model AP260 without ASTOLINE 43°C SET: 39°C 41°C Flow [ml/min] Fig. 4: Fluid outlet temperature (patient connection) at 20°C inlet temperature...

  • Page 21: Components Of The Astotherm Plus

    6 Product description ASTOTHERM PLUS Instructions for Use 6.3 Components of the ASTOTHERM PLUS Fig. 5: ASTOTHERM PLUS (AP220S) # Item Description Control buttons and displays. 1 Control Panel (s. chapter 6.5 Control panel) 2 Bracket* Fixes ASTOLINE* Active insulation of the infusion extension up to the 3 ASTOLINE* patient (s.

  • Page 22: Applied Part Astoline

    ASTOTHERM PLUS Instructions for Use 6 Product description # Item Description 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 during...

  • Page 23: Control Panel

    6 Product description ASTOTHERM PLUS Instructions for Use 6.5 Control panel „S“models only Fig. 7: Control panel Item Description “Standby” LED Illuminates blue when the warmer is in Standby Mode. Turns the warmer from Standby Mode to On Mode. “Standby”...
  • Page 24 ASTOTHERM PLUS Instructions for Use 6 Product description Item Description Setpoint Shows the three possible setpoint temperatures. The frame Temperatures indicates the selected temperature. “ASTOLINE“ Switches ASTOLINE on / off when the warmer is in On Mode. button “ASTOLINE“ Illuminates green, when ASTOLINE is switched on.

  • Page 25: Operating States

    7 Operating states ASTOTHERM PLUS Instructions for Use 7 Operating states 7.1 Standby mode Control Panel When the mains cable is plugged into the socket, the device is in Standby Mode. Action Alternately, press the “Standby” button to switch the device from any Mode to Standby Mode.

  • Page 26: On Mode

    ASTOTHERM PLUS Instructions for Use 7 Operating states 7.2 On mode Control Panel Press the “Standby” button to switch the device from Action Standby Mode to On Mode. • “Standby” LED turns off. • “On” LED turns on. • The backlight of the display lights up.

  • Page 27: Heating Mode

    7 Operating states ASTOTHERM PLUS Instructions for Use 7.3 Heating mode Control Panel Press the “Start” button at least for one second to switch Action the warmer from On Mode to Heating Mode. • While the button is pressed, a self-test is performed.

  • Page 28: Increasing/Decreasing The Setpoint Temperature

    • During operation, the mean temperature of the heat exchanger is displayed; this is not equal to the temp- erature of the medium to be warmed. ASTOTHERM PLUS neither regulates nor monitors/displays the current temperature of the medium to be warmed.

  • Page 29: Astoline* On Mode

    7 Operating states ASTOTHERM PLUS Instructions for Use 7.5 ASTOLINE* On mode Control Panel Briefly press the “ASTOLINE” button while the device is Action in On Mode or Heating Mode. “ASTOLINE” LED turns on green. Device response • The active insulation ASTOLINE slowly warms up.

  • Page 30: Installation

    ASTOTHERM PLUS Instructions for Use 8 Installation 8 Installation 8.1 Initial start-up Prior to first use, perfom the following inspections: Visual Inspection (s. chapter 12.1 Recurrent tests) • Check the mains voltage (compare the details on the type label with the •...

  • Page 31: Getting Started

    9.1 Preparation for use WARNING Risk of injury! Do not use the ASTOTHERM PLUS until the following error conditions have been remedied through appropriate corrective action: - Damaged or worn cables, plugs, or connecting socket. - Damaged housing, damaged or loose control panel.
  • Page 32 Using normal infusion stands ASTOTHERM PLUS may be mounted at a height of up to165 cm. If you use the robust IV pole ASTOSTAND, the device can be mounted up to 180 cm.
  • Page 33 9 Getting started ASTOTHERM PLUS Instructions for Use 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 green.

  • Page 34: Inserting The Infusion Line, Priming And Starting The Infusion

    • 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 improve the patient's well-being.
  • Page 35 9 Getting started ASTOTHERM PLUS Instructions for Use 1. Detach the heat protection sleeve (optional) by gently pulling apart the two grips. Fig. 9: Inserting the infusion extension (start) 2. Clip the IV end of the infusion extension (female Luer Lock) into the rear tube holder (fig.
  • Page 36 ASTOTHERM PLUS Instructions for Use 9 Getting started Additionally for „S“ models: 10-A 10-B 10-C Fig. 10: The use of ASTOLINE 5. Starting from the patient side, place the end of the infusion extension with 3 to 5 cm overlap into ASTOLINE (fig. 10-A) and insert it with the thumb into the groove of ASTOLINE (fig.
  • Page 37 ASTOLINE and heat protection sleeve (without ASTOLINE and without heat protection sleeve) The infusion extension is now free hanging with ASTOLINE (fig. 12) or without ASTOLINE (fig.13) between the patient and ASTOTHERM PLUS and the treatment can be started. WARNING Risk of overheating! •...

  • Page 38: After Use

    PLUS and ASTOLINE („S“ models only). 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. 3. Disconnect the infusion extension from the cannula. Only for „S“ models: 4.

  • Page 39: Cleaning And Disinfecting

    • Do not use cleaning and disinfection procedures which differ from the procedure described. ASTOTHERM PLUS Clean and wipe-disinfect ASTOTHERM PLUS in accordance with the procedure below: 1. Disconnect the mains plug from the socket. 2. Clean all surfaces with a soft cloth/cotton swab and mild soap-and-water solution.
  • Page 40 ASTOTHERM PLUS Instructions for Use 9 Getting started ASTOLINE Clean and wipe-disinfect ASTOLINE in accordance with the procedure below: 1. Clean all surfaces of the heating profile including the groove with a soft cloth/ cotton swab and a mild soap-and-water solution or with water only.

  • Page 41: Alarms And Troubleshooting

    Thus, the overheating of the heated liquid is surely prevented. ASTOTHERM PLUS does not require continuous supervision by the operator, but it must be checked at regular intervals (depending on the condition of the patient status).

  • Page 42: Low Temperature Alarm

    Reduce flow rate. Required ► ► action(s) Warmer is defective. Return ASTOTHERM PLUS to local sales office. ► Possible actions to None, the alarm is automatically disabled if the alarm clear condition is eliminated. During warm up phase, as long as the actual temperature is 4°C below the selected setpoint temperature, low...

  • Page 43: Overheating Alarm

    Required ► Eliminate heat source and/or select cooler location. ► action(s) Warmer is defective. Return ASTOTHERM PLUS to local sales office. ► Press the “Start” button“ to switch the device back to Heating Mode (after cooling down). Possible actions to clear Press the “Standby”...

  • Page 44: Cable Break Alarm

    • A defect of the cable break detection or a temperature Alarm condition sensor break has been detected. Warmer is defective. Possible reason(s) Return ASTOTHERM PLUS to local sales office. Required ► ► action(s) Press the “Standby” button to switch the device to Possible actions to Standby Mode.

  • Page 45: Astoline Alarm ("S" Models Only)

    1. Press the “ASTOLINE” button to switch off Possible actions to ASTOLINE. clear 2. Press the “Start” button to switch the device to Heating Mode. In the case of a defective ASTOLINE, ASTOTHERM PLUS can be used with deactivated ASTOLINE.

  • Page 46: Processor Alarm

    ► Permanent program fault caused by defect data file. Required ► Return ASTOTHERM PLUS to local sales office. action(s) ► 1. Press the “Increase” button and the “Decrease” button at the same time until the device switches to Standby Possible actions Mode.

  • Page 47: Standby Mode - Failure

    ► 1. Plug the warmer into functioning socket. Required ► 2. Press the “Standby” button action(s) 3. Press then the “Start” button to switch the device to Heating Mode. Warmer is defective. Return ASTOTHERM PLUS to local sales office. ►...

  • Page 48: Brief Overview Of Operating States And Alarms

    ASTOTHERM PLUS Instructions for Use 11 Brief overview of operating states and alarms 11 Brief overview of operating states and alarms 11.1 Overview of operating states blue green yellow green green Operating Possible state reason(s) Standby Mode ≤ 15°C ≥ 50°C On Mode ≤...

  • Page 49: Overview Of Alarms

    11 Brief overview of operating states and alarms ASTOTHERM PLUS Instructions for Use 11.2 Overview of alarms blue green yellow green green Possible Alarm reason(s) Low temperature ≤ T - 4°C) because of cold sounds Temperature liquid/high flow every 2...

  • Page 50: Maintenance

    12.1 Recurrent tests 12.1.1 Warmer ASTOTHERM PLUS (ASTOLINE see 12.1.2) A recurrent test must be carried out on the ASTOTHERM PLUS warmer at least every 24 months to ensure the safe operation of the warmer. Please ensure that all the applicable national directives (e.g. IEC/EN 62353) for checking the safety of medical equipment are observed additionally and that the test equipment is calibrated.

  • Page 51: Insulation Resistance

    12 Maintenance ASTOTHERM PLUS Instructions for Use The following sections describe how the tests are to be performed. The attached test protocol (see chapter 12.3 Test protocol) can be used. Test 1 Visual inspection Check the following items: Required • Complete and legible labeling.
  • Page 52 ASTOTHERM PLUS Instructions for Use 12 Maintenance Test 4.1 Equipment leakage current (alternative method) Optional to test 4.2 Required Measure the current flowing from protective earthed conductor Actions to the two (shorted) power supply connections. For detailed information performing this test see chapter 12.2 Set up for electrical tests.
  • Page 53 12 Maintenance ASTOTHERM PLUS Instructions for Use Test 5 Temperature control and display Required 1. Insert the clinical thermometer Actions into the rear measuring bore on the side of the heat exchanger. Fig. 14: Temperature 2. Plug the mains plug into a socket.
  • Page 54 ASTOTHERM PLUS Instructions for Use 12 Maintenance Test 6 Manual excessive temperature cut off 1 Required 1. Operate the Warmer with the middle setpoint temperature. Actions 2. Hold down the “Start” button at least for 3 seconds, to start the test.
  • Page 55 12 Maintenance ASTOTHERM PLUS Instructions for Use Test 8 Manual low temperature alarm Required 1. Operate the Warmer with the lowest setpoint temperature. Actions 2. Hold down the “Decrease” button at least for 3 seconds, to start the test. Result...

  • Page 56: Visual Inspection

    ASTOTHERM PLUS Instructions for Use 12 Maintenance Test 9 Manual ASTOLINE cut off („S“ models only) Required 1. Operate the Warmer with any setpoint temperature. Actions 2. Do not connect ASTOLINE to the designated appliance socket or disconnect the plug of ASTOLINE.

  • Page 57: Set Up For Electrical Tests

    12 Maintenance ASTOTHERM PLUS Instructions for Use Test 11 Functional test Required Operate ASTOLINE together with the warmer ASTOTHERM actions PLUS. Result The test is successful, when ASTOLINE can be switchen on with the “ASTOLINE” button • The “ASTOLINE” LED illuminates green •...

  • Page 58: Test Protocol

    ASTOTHERM ASTOLINE Test Equipment PLUS Type Type Date of calibration Test 1: Visual inspection Labeling and markings on ASTOTHERM PLUS Control panel (front foil) Housing Power supply cord Attachment device Test 2: Protective earth resistance Value [Ω] Max [Ω] P/F/NA...

  • Page 59: Manual Tests

    12 Maintenance ASTOTHERM PLUS Instructions for Use Test 5: Temperature control and display Value [°C] Min [°C] Max [°C] Selected setpoint temperature T (max. 41°C) Temperature measurement TT T – 0.5 T + 0.5 (with clinical thermometer) Actual temperature (displayed) TD T –...

  • Page 60: Technical Data

    43.5°C (± 0.5°C) Low temperature alarm – 4°C (± 0.5°C) Setpoint Heating up time (22°C to 40°C) approx. 1 minute Self-start after power interruption up to 5 seconds ASTOLINE 8 W rated power supplied with 22 VDC from ASTOTHERM PLUS...

  • Page 61: Compliance With International Standards

    14 Compliance with international standards ASTOTHERM PLUS Instructions for Use 14 Compliance with international standards Standard Title IEC/EN 60601-1 ANSI/AAMI ES 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance CAN/CSA C22.2 No. 60601-1...

  • Page 62: Ordering Information, Accessories And Consumables

    ASTOTHERM PLUS Instructions for Use 15 Ordering information, accessories and consumables 15 Ordering information, accessories and consumables You can order an ASTOTHERM PLUS Warmer using the following order numbers: Description (Order-No.) For 4 mm infusion line, AP220xx without ASTOLINE, Heat Protection Sleeve optional...

  • Page 63: Guidelines And Manufacturer's Declaration

    16 Guidelines and manufacturer’s declaration Guidance and manufacturer's declaration - electromagnetic emissions ASTOTHERM PLUS is intended for use in the electromagnetic environment specified below. The customer or user of the ASTOTHERM PLUS should assure that it is used in such an environment.
  • Page 64 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 above, the ASTOTHERM PLUS should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the ASTOTHERM PLUS.

This manual is also suitable for:

Ap220Ap220sAp260Ap260s

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