STIHLER ELECTRONIC ASTOTHERM plus Instructions For Use Manual
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STIHLER ELECTRONIC ASTOTHERM plus Instructions For Use Manual

For blood, intravenous fluids and irrigation fluids
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Instructions for use
®
ASTOTHERM
plus
Warmer for Blood, Intravenous
Fluids and Irrigation Fluids
REF
AP220
STIHLER ELECTRONIC GmbH • 70597 Stuttgart • Germany

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Summary of Contents for STIHLER ELECTRONIC ASTOTHERM plus

  • Page 1 Instructions for use ® ASTOTHERM plus Warmer for Blood, Intravenous Fluids and Irrigation Fluids AP220 STIHLER ELECTRONIC GmbH • 70597 Stuttgart • Germany...
  • Page 2 E-Mail: info@stihlerelectronic.de © 2017 STIHLER ELECTRONIC GmbH 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.

  • Page 3: Table Of Contents

    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 ......................19 7.2 On mode ........................
  • Page 4 11 Brief overview of operating states and alarms ............36 12 Maintenance .........................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 consumables ..........49 16 Guidelines and manufacturer’s declaration ..............50...

  • 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  This device may only be operated by appropriately trained and medically qualified healthcare professionals.  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 or plugs.
  • Page 9  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 is undamaged.  The mains plug must be removed from the socket to fully disconnect the...

  • Page 10: 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 11: 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 12: Specification Of Application

    4.5 Intended 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 professionals. 4.7 Intended use/operation environment  The warmer may only be used in professional healthcare facilities (e.g. hospital, emergency care, dialysis, including HF surgical equipment, etc.).

  • Page 13: Symbols

    1993 for medical devices. The Notified Body DEKRA Certifications GmbH (Reg. No. 0124) monitors the quality system of the manufacturer. The CE mark applies only to the ASTOTHERM PLUS Warmer. Disposable parts (e.g. infusion sets) suitable for use with this device have their own approvals.
  • Page 14 ASTOTHERM PLUS Instructions for Use 5 Symbols MEDICAL – GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH standards ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012), C1:2009/(R)2012 and A2:2010/(R):2012 75JA CAN/CSA-C22.2 No. 60601-1:2014. Control No. 75JA This symbol indicates additional information.

  • Page 15: Product Description

    6 Product description 6.1 Introduction 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 16  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 17: Components Of The Astotherm Plus

    6 Product description ASTOTHERM PLUS Instructions for Use 6.3 Components of the ASTOTHERM PLUS Fig. 2: ASTOTHERM PLUS AP220 # Item Description Control buttons and displays. 1 Control Panel (s. chapter 6.4 Control panel) Transfers heat from the internal heating element...

  • Page 18: Control Panel

    ASTOTHERM PLUS Instructions for Use 6 Product description 6.4 Control panel Fig. 3: 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” button” Turns the warmer from any Mode to the Standby Mode.

  • Page 19: Operating States

    7 Operating states ASTOTHERM PLUS Instructions for Use Item Description LCD Display Informs the user about temperatures, test and fault conditions. Actual Temperature Displays the current temperature of the heat exchanger. Setpoint Shows the three possible setpoint temperatures. The frame Temperatures indicates the selected temperature.

  • Page 20: 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 21: 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 22: 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 23: Installation

    8 Installation ASTOTHERM PLUS Instructions for Use 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 available mains voltage.) An incorrect mains voltage may destroy the...

  • Page 24: Getting Started

    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 25 9 Getting started ASTOTHERM PLUS Instructions for Use 1. Attach ASTOTHERM PLUS to an IV pole or to a medical standard rail using the attachment device according to chapter 8.2 Installation of the warmer. 2. Plug the mains plug into a socket.

  • Page 26: 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 27 9 Getting started ASTOTHERM PLUS Instructions for Use Fig. 4: Inserting the infusion extension 1. Clip the IV end of the infusion extension (female Luer Lock) into the rear tube holder (fig. 4-A). 2. Starting from the back, wind and insert the infusion extension in a counter clockwise direction up and around into the circumferential groove of the heat exchanger (fig.

  • Page 28: After Use

    To disconnect ASTOTHERM PLUS from the mains, it is necessary to completely pull out the plug. 3. Disconnect the infusion extension from the cannula. 4. Wrap the infusion extension out from the circumferential groove of the heat exchanger. 5. Clean and disinfect ASTOTHERM PLUS after each treatment and if required.

  • Page 29: Cleaning And Disinfecting

     thermo-chemical cleaning solutions. Refer to the specific instructions for use of the disinfectants. 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 30: 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 31: 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 32: 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 33: 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 34: 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 35: Standby Mode - Failure

    1. Plug the warmer into functioning socket. reason(s) ► 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 36: 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 blue yellow green green Operating Possible state reason(s) Standby Mode ≤ 15°C ≥ 50°C On Mode ≤ 15°C Heating Mode „Start”...
  • Page 37 11 Brief overview of operating states and alarms ASTOTHERM PLUS Instructions for Use blue yellow green green Possible Alarm reason(s) Low temperature ≤ T - 4°C) sounds Temperature because of cold every 2 Alarm liquid/high flow rate min. or device defective Excessive >...

  • Page 38: Maintenance

     Risk of injury!  The service personnel must be appropriately trained and qualified.  The ASTOTHERM PLUS does not contain any parts the user can repair. Therefore, do not attempt to repair the ASTOTHERM PLUS yourself. Contact your local sales point.

  • Page 39: Recurrent Tests

    ASTOTHERM PLUS Instructions for Use 12.1 Recurrent tests 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 40 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 41 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. 6: Temperature measurement 2. Plug the mains plug into a socket.
  • Page 42 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 43 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 The test is successful, when: ...

  • Page 44: Set Up For Electrical Tests

    ASTOTHERM PLUS Instructions for Use 12 Maintenance 12.2 Set up for electrical tests For measuring the protective earth resistance, the insulation resistance and the equipment/earth leakage current, the following test set up can be used: Measurement (True RMS) Use connection to...

  • Page 45: Test Protocol

    12.3 Test protocol ASTOTHERM PLUS Test equipment 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]...
  • Page 46 ASTOTHERM PLUS Instructions for Use 12 Maintenance 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) T – 0.3 Actual temperature (displayed) TD T + 0.3...

  • Page 47: Technical Data

    13 Technical data ASTOTHERM PLUS Instructions for Use 13 Technical data ASTOTHERM PLUS ..AU ..EU ..NA AP220..UK Electrical connection 230 - 240 VAC 100 - 115 VAC 50 – 60 Hz 50 – 60 Hz Fuses primary (F1 F2)

  • Page 48: Compliance With International Standards

    ASTOTHERM PLUS Instructions for Use 14 Compliance with international standards 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 49: Ordering Information, Accessories And Consumables

    15 Ordering information, accessories and consumables ASTOTHERM PLUS Instructions for Use 15 Ordering information, accessories and consumables You can order an ASTOTHERM PLUS Warmer using the following order numbers: Description (Order-No.) AP220AU For 4 mm infusion line, 230 - 240 VAC, Australian Plug...

  • Page 50: 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 51 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.

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