ASTOTHERM Plus Models REF AP220 - AP220S and REF AP260 - AP260S Instructions for Use Rev 03 Oct 2017

To be filled in by the user: 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]

© 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.

Contents 1 Information about these Instructions ...5 2 General information ...5 2.1 Guarantee conditions...5 2.2 Liability...5 2.3 Disposal of the equipment ...6 2.4 Return of a used product ...6 2.5 Service information ...6 3 Important safety information ...7 3.1 Dangers ...7 3.2 Warnings ...7 3.3 Cautions ...11 3.4 Notices... 12 4 Specification of application ... 13 4.1 Intended use ...13 4.2 Intended medical indication ... 13 4.3 Contraindications ...13 4.4 Possible adverse effects ... 13 4.5 Intended patient population ... 13 4.6 Intended user profile ...13 4.7 Intended use/operation environment ...13 4.8 Intended part of the body/type of tissue ...14 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 ...25 7.2 On mode ...26 7.3 Heating mode ...27 7.4 Increasing/Decreasing the setpoint temperature ... 28 7.5 ASTOLINE* On mode ... 29 7.6 ASTOLINE* Off mode ... 29 8 Installation ...30 8.1 Initial start-up ...30 8.2 Installation of the warmer ... 30 9 Getting started ...31 9.1 Preparation for use ...31 9.2 Inserting the infusion line, priming and starting the infusion ...34 9.3 After use ...38 9.4 Cleaning and disinfecting ... 39

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... 48 11.1 Overview of operating states ... 48 11.2 Overview of alarms ... 49 12 Maintenance ... 50 12.1 Recurrent tests ... 50 12.2 Set up for electrical tests ... 57 12.3 Test protocol ... 58 13 Technical data ... 60 14 Compliance with international standards ... 61 15 Ordering information, accessories and consumables ... 62 16 Guidelines and manufacturer’s declaration ... 63

1 Information about these Instructions

ASTOTHERM PLUS Instructions for Use

1 Information about these Instructions  Carefully read the entire instructions for use before using the device.  Correct and safe operation can only be guaranteed if the instructions for use are observed.  Incorrect use can result in damage to the product or to other property and/or personal injury.  Keep the instructions for use for future reference.  Only use the device for the intended purpose as described in these instructions for use. Refer to chapter 4 Specification of application.

2 General information 2.1 Guarantee conditions The guarantee period is 12 months. During this guarantee period the manufacturer will repair or replace free of charge all defects caused as a result of material or manufacturing errors. Other damage is not subject to this guarantee. The guarantee does not include cases of misuse or incorrect 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 condition. 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. 2.2 Liability The manufacturer is only liable for the safety, reliability and performance of the equipment  if all operating, servicing, and calibration procedures have been carried out by trained and qualified persons according to the procedures published by the manufacturer;  if only original spare parts have been used to replace components as needed;  if assembly and repairs are only carried out by authorised personnel or an authorised service centre;  if the electrical installations satisfy the locally applicable regulations and the IEC/EN requirements and  if the equipment is used for its intended purpose and at a suitable location in accordance with the instructions for use.

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ASTOTHERM PLUS Instructions for Use

2 General information

2.3 Disposal of the equipment Electrical devices are recoverable waste and should not be disposed of in domestic waste at the end of their service life. 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. Follow the national regulations on the disposal of medical products. 2.4 Return of a used product A report must be sent together with the equipment, detailing 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 packaging. WARNING Risk of infection! Clean and disinfect the equipment after every use and before you return the equipment for repairs. NOTICE The customer is responsible for the proper packaging and labelling of returns. 2.5 Service information For service or technical support, please contact your local sales point or the following: STIHLER ELECTRONIC GmbH Julius-Hoelder-Strasse 36 70597 Stuttgart GERMANY

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Tel. +49 (0) 711-720670 Fax +49 (0) 711-7206757 www.stihlerelectronic.de E-Mail: [email protected]

3 Important safety information

ASTOTHERM PLUS Instructions for Use

3 Important safety information These Instructions for Use indicate and define the following safety information: DANGER DANGER indicates a hazardous situation which, if not avoided, will result in death or serious injury. WARNING WARNING indicates a hazardous situation which, if not avoided, could result in death or serious injury. CAUTION CAUTION indicates a hazardous situation which, if not avoided, may result in minor or moderate injury. 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.  Read and observe all instructions, stickers, and accompanying documentation enclosed with the medical device. Failure to observe the instructions, including warnings and safety information, can result in incorrect handling, patient injury, injury to users or medical personnel, damage to the device, or material damage.  Operate and service this equipment only in accordance with the procedures described in these instructions and with the applicable standards, rules, and guidelines. The manufacturer shall not be responsible for the safety of users or patients if any actions/procedures other than those published are carried out during operation, servicing, or recurrent tests.

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ASTOTHERM PLUS Instructions for Use

3 Important safety information

WARNING Risk of injury!  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, plugs, or connecting socket. - 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 cause. - Damaged ASTOLINE („S“-models only), e.g. caused by clamps, scissors or improper handling or storage. - Damaged or missing markings/safety signs/warnings on the warmer and/or ASTOLINE.  If the yellow “Alarm” LED and the acoustic alarm signal are not activated automatically, when the device turns on by pressing the “Standby” Button, remove the device from service immediately.  In the event of an overheating alarm proceed 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 treatment to prevent fluid from returning to the patient. Remove the applicable tubing immediately from the heat exchanger. Further evaluation should be carried out by qualified medical personnel such as a physician before blood in the line can be reinfused. 2. Consider the possible reasons for the alarm. For further information see chapter 10 Alarms and troubleshooting. If in doubt, do not continue using the warmer.  The mains cable should not touch the patient and should not hinder the treating personnel.  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.  Any repairs (such as, but not limited to, changing the power supply cord) to the equipment may only be carried out by persons authorized and qualified by the manufacturer.  Modifications to the device are not permitted.

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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.  Do not place ASTOLINE under or directly beside the patient. Heat build-up can occur and/or the infusion extension can be squeezed off.  Do not kink or clamp ASTOLINE during storage, to avoid internal damage. WARNING Risk of haemolysis! Make sure that the infusion line is not kinked. WARNING Risk of air embolism!  When fluids are warmed up, it is possible that gas may evolve (bubble form).  Be aware of the potential for air emboli when using a blood and fluid warmer.  Therefore prime all filters, lines and disposable sets before starting a treatment.  Make sure all connections 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 care should always be taken to ensure that a bolus o fair does not pass to the patient. WARNING Risk of infection!  Use aseptic procedures.  Clean and disinfect the warmer after every use and before you return the warmer for repairs.

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ASTOTHERM PLUS Instructions for Use

3 Important safety information

WARNING Risk of electric shock!  To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.  Do not use mains adapters that interrupt the earth conductor.  Do not open the ASTOTHERM PLUS housing.  If several pieces of equipment are combined or connected together (e.g., in multiple socket outlets), the total leakage currents must not exceed the allowable limits (refer to the respective national regulations). Observe the requirements as stipulated in IEC/EN 60601-1 regarding medical electrical systems.  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. WARNING Risk of radio interference!  Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.  Use of accessories, other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.  Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the ASTOTHERM PLUS, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

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3 Important safety information

ASTOTHERM PLUS Instructions for Use

3.3 Cautions 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. Using normal infusion stands ASTOTHERM PLUS may be mounted at a height of up to 165 cm. If you use the robust IV pole ASTOSTAND, the device can be mounted up to 180 cm.  Use only approved infusion sets / infusion extensions (e. g. ASTOTUBE, see chapter 15 Ordering information, accessories and consumables). Damage to ASTOLINE can cause overheating, therefore follow the instructions below:  Only disinfect ASTOLINE with alcohol-based agents or an approved disinfectant.  Do not use solutions containing hypochlorite (bleach) for disinfecting ASTOLINE.  Do not kink or pull excessively ASTOLINE.  Do not use any clamps or sharp instruments on ASTOLINE as damage to ASTOLINE or the infusion line inside may result.  Use narrow plaster strips or other narrow, soft fixation methods (for example ® cannula fixation, tube holder or Velcro ) to fix ASTOLINE.  Do not use cleaning and disinfection procedures which differ from the procedure described. CAUTION Risk of hypothermia!  When ASTOTHERM PLUS is used, the patient’s body temperature must be montitored at regular intervals.  The specified heating performance will only achieved by inserting the infusion extension into the entire heat exchanger and, if applicable, in the entire length of ASTOLINE.  The temperatur control of the ASTOTHERM PLUS controls and monitors the current temperature of the heat exchanger, but not the patient’s body temperature.  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.

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ASTOTHERM PLUS Instructions for Use

3 Important safety information

CAUTION Risk of needle dislodgement! The weight of ASTOLINE („S“-models only) pulls on the patient’s infusion line. Carefully secure the patient’s access against pulling. Attach the ASTOLINE by ® suitable methods (e.g. tape, plaster or Velcro ). CAUTION Risk of radio interference!  The essential performance can be lost or degrated due to EM disturbances. As a result, there is the possibility of hypothermia of the patient.  According to the standard IEC/EN 60601-1-2, medical electrical equipment requires special precautions regarding electromagnetic compatibility (EMC) and needs to be installed and put into service according the EMC information provided.  This device/system may cause radio interference or may disrupt the operation 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  To avoid damage to the warmer: - Do not immerse the warmer or ASTOLINE in liquid. - Do not disinfect the warmer with these methods:  steam (autoclave)  hot air  thermo-chemical cleaning solutions. - Refer to the specific instructions for use of the disinfectants.  To avoid damaging during storage, place ASTOLINE loosely around the warmer and do not kink or clamp it. Use narrow plaster strips or other narrow, ® soft fixation methods (for example cannula fixation, tube holder or Velcro ) to fix ASTOLINE.  The customer is responsible for the proper packaging and labelling of returns.  Only the active insulation ASTOLINE must be connected to the appliance socket of the “S” models.

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4 Specification of application

ASTOTHERM PLUS Instructions for Use

4 Specification of application 4.1 Intended use ASTOTHERM PLUS is a warmer for Blood, Intravenous Fluids and Irrigation Fluids. The application areas include blood transfusions, intravenous fluids, dialysis, hemofiltration and apheresis. 4.2 Intended medical indication The warming of medical fluids with ASTOTHERM PLUS supports the prevention and therapy of hypothermia. 4.3 Contraindications 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 effluent flow rates (below 500 ml/h) for patients who weigh less than 30 kg. Global positive heat balance and net patient warming may occur. If necessary, operate the warmer at a reduced temperature setting. 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.).  The warmer is not intended for home healthcare environment.  The warmer is reusable, but requires cleaning / disinfection between the applications.  Appropriate medical hygienic factors must be applied for the use of the warmer.  The warmer must not be used in an environment at risk of explosion or in the present of flammable anesthetics.

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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). The optional applied part ASTOLINE may have skin contact.

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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” button increases the setpoint temperature “Decrease” button decreases the setpoint temperature “ASTOLINE” button for switching On/Off the active insulation Where these symbols are applicable, they appear at the relevant point on the device, the package, the rating plate or in the accompanying paperwork. Defibrillation-proof type B applied part in accordance 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 order of a physician. General warning sign Catalogue number Serial number Year of manufacture Manufacturer Prohibition: Do not cover the active insulation ASTOLINE – risk of overheating! Prohibition: Do not clamp the active insulation ASTOLINE – risk of damage and possible overheating! Prohibition: Do not disinfect the active insulation ASTOLINE with Hypochlorite solution – risk of damage and possible overheating! 15

ASTOTHERM PLUS Instructions for Use

75JA

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. The device is conform to the MDD 93/42/EEC dated 14th June 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. 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 CAN/CSA-C22.2 No. 60601-1:2014. Control No. 75JA This symbol indicates additional information. Indicates the 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 package must be stored and handled. Indicates the upright position of the package The package must be kept in a dry environment. The contents of the package are fragile and must therefore be handled with care. Do not drop or throw. Recyclable - Polystyrene (acc. GB 18455-2001) Recyclable - Cardboard (acc. GB 18455-2001)

CB

Acoustic alarm signal No acoustic alarm signal

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6 Product description

ASTOTHERM PLUS Instructions for Use

6 Product description 6.1 Introduction 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; during longer procedures such as dialysis, hemofiltration, or apheresis the warming leads to a well-being. The applications of the ASTOTHERM PLUS therefore include transfusion, infusion, dialysis, hemofiltration and apheresis. The ASTOTHERM PLUS Warmer can be used to warm fluids administered to a patient at flow rates of 0 to 6000 ml/h (i.e. 0 to 100 ml/min), see figures 1 to 4. In the case of low flow rates, the re-cooling of the heated fluid on the way from the warmer to the patient is limited by using the active insulation ASTOLINE („S“ models only). The heated flexible silicone body surrounds the infusion extension on the way to the patient, ensuring that the part of the infusion line which would otherwise be exposed to cool ambient air is insulated and heated. Its special shape also enables infusions and transfusions to be observed all the way to the patient. The active insulation ASTOLINE and the infusion extension ASTOTUBE are considered as applied part acc. to IEC/EN 60601-1. 6.2 Technical description During operation 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 transferred through the inserted infusion extension to the fluid to be warmed. The temperature of the heat exchanger is monitored by a microprocessor controlled temperature control system and by two independent alarm systems designed to alert the operator to failure conditions and, if necessary, to switch off the heating process automatically in the event of excessively high temperatures. During operation, the mean temperature of the heat exchanger is displayed; this is not equal to the temperature of the medium to be warmed. ASTOTHERM PLUS neither regulates nor monitors/displays the current temperature of the medium to be warmed. The temperature of the medium (fluid) depends on a variety of factors, such as, but not limited to additional factors:  Room temperature and ventilation  Inlet temperature of the fluid (warmed-up or cold)  Flow rate The heat protection sleeve (option) protects infusions from the effects of external cold (e.g. air condition) and prevents heat being given off into the room.

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ASTOTHERM PLUS Instructions for Use

6 Product description

CAUTION Risk of hypothermia!  When ASTOTHERM PLUS is used, the patient’s body temperature must be montitored at regular intervals.  The specified heating performance will only achieved by inserting the infusion extension into the entire heat exchanger and, if applicable, in the entire length of ASTOLINE.  The temperature control of the ASTOTHERM PLUS controls and monitors the current temperature of the heat exchanger, but not the patient’s body temperature.  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.

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6 Product description

ASTOTHERM PLUS Instructions for Use

Typical temperature curves are shown in the following figures. 10 ml/min = 0,6 l/h 20 ml/min = 1,2 l/h 30 ml/min = 1,8 l/h 40 ml/min = 2,4 l/h 50 ml/min = 3,0 l/h

60 ml/min = 3,6 l/h 70 ml/min = 4,2 l/h 80 ml/min = 4,8 l/h 90 ml/min = 5,4 l/h 100 ml/min = 6,0 l/h

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Temperature [°C]

42 40 38 36 34 SET: 37°C

32 0

10

20

30

40

50

60

39°C

41°C

70

80

43°C

90

100

Flow [ml/min]

Fig. 1: Fluid outlet temperature (device outlet) at 10°C inlet temperature model AP220 without ASTOLINE

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Temperature [°C]

42 40 38 36 34 SET: 39°C

43°C

41°C

32 0

10

20

30

40

50

60

70

80

90

100

Flow [ml/min]

Fig. 2: Fluid outlet temperature (patient connection) at 20°C inlet temperature model AP220S with ASTOLINE

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ASTOTHERM PLUS Instructions for Use

6 Product description

44

Temperature [°C]

42 40 38 36

34

SET: 37°C

39°C

32 0

10

20

30

40

50

60

70

41°C

43°C

80

90

100

Flow [ml/min]

Fig. 3: Fluid outlet temperature (device outlet) at 20°C inlet temperature model AP260 without ASTOLINE

44

Temperature [°C]

42 40 38 36 34

43°C

SET: 39°C

41°C

32 0

10

20

30

40

50

60

70

80

90

Flow [ml/min]

Fig. 4: Fluid outlet temperature (patient connection) at 20°C inlet temperature model AP260S with ASTOLINE

20

100