ASTOPAD DUO310 Instructions for Use Rev 07 Feb 2018

To be completed 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]

© 2018 STIHLER ELECTRONIC GmbH

STIHLER ELECTRONIC GmbH, Stuttgart, declares in sole responsibility that this product 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 Information about the Batteries Act (BattG) ... 6 2.5 Return of a used product ... 6 2.6 Service information ... 7

3 Important safety information ... 7 3.1 Dangers ... 7 3.2 Warnings ... 8 3.3 Cautions ... 11 3.4 Notices ... 12

4 Specification of the application ... 13 4.1 Intended purpose ... 13 4.2 Intended medical indications ... 13 4.3 Contraindications ... 13 4.4 Possible adverse effects ... 13 4.5 Intended patient target group ... 13 4.6 Intended user profile ... 13 4.7 Intended environment of use/operation ... 13

5 Symbols ... 14 6 Product description ... 17 6.1 Introduction ... 17 6.2 Technical description ... 17 6.3 Components of the ASTOPAD ... 19 6.4 Control panel ... 21

7 Operating states ... 22 7.1 Standby mode ... 22 7.2 On mode ... 23 7.3 Heating mode output A and/or B ... 24 7.4 Increasing/decreasing the set temperature ... 25 7.5 Switching off an output (A or B)... 26 7.6 Storage/transportation ... 26

8 Installation ... 27 8.1 Putting into service ... 27 8.2 Installation of the Control unit ... 27

9 Getting started ... 28 9.1 Preparation for use ... 30 9.2 Starting the heating process... 32 9.3 Selecting a new set temperature ... 33 9.4 Switching off an output ... 33 9.5 Switching off the ASTOPAD ... 33 9.6 Cleaning and disinfection ... 33

10 Alarms and troubleshooting... 35 10.1 Low temperature alarm “A1”... 36 10.2 Overheating alarm “A2” ... 37 10.3 Time alarm “A3” ... 38 10.4 Overheating alarm shut-off “A4” ... 39 10.5 Sensor defect alarm “A5” ... 40 10.6 Heater defect alarm “A6” ... 41

11 Information messages and troubleshooting ... 42 11.1 No applied part connected ... 42 11.2 Battery state ... 42 11.2 Battery defective ... 43 11.3 Applied part temperature too low ... 43 11.4 Applied part temperature too high ... 44

12 Brief overview of operating states and alarms ... 45 12.1 Overview of operating states ... 45 12.2 Overview of alarms... 47

13 Maintenance ... 48 13.1 Recurrents tests ... 48 13.2 Replacing the battery ... 49

14 Technical data ... 50 15 Conformity with international standards ... 53 16 Ordering information and Accessories ... 54 17 Guidelines and manufacturer’s declaration ... 56

1 Information about these instructions

ASTOPAD® 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 the section “Specification of the 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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ASTOPAD® 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 Information about the Battery Batteries must not be disposed of in domestic waste. The user is obliged to carry out proper disposal. Returns can be made to public communal collection points or wherever the batteries are sold. The battery can be removed by loosening the 4 screws on the underside and opening the housing.

2.5 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. Transport rule for the return of device with built-in battery: When returning ASTOPAD DUO310 control units, it is essential to ensure that the control unit is in storage / transport condition (see chapter 7.6 "Storage / transportation").

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.

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3 Important safety information

ASTOPAD® Instructions for Use

2.6 Service information For service or technical support, please contact your local sales point or the following: STIHLER ELECTRONIC GmbH Tel. +49 (0) 711-720670 Fax +49 (0) 711-7206757 Julius-Hoelder-Strasse 36 www.stihlerelectronic.de 70597 Stuttgart E-Mail: [email protected] GERMANY

3 Important safety information These instructions for use define and refer to 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, could result in minor or moderate injury. NOTICE NOTICE indicates a property damage message.

3.1 Dangers DANGER Explosion hazard! Do not use the ASTOPAD patient warming system in an explosion-hazard environment or in the presence of flammable anaesthetics.

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ASTOPAD® Instructions for Use

3 Important safety information

3.2 Warnings WARNING Risk of injury! • ASTOPAD is only to be used under the direction 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 test. • This device may only be operated by appropriately trained and medically qualified healthcare professionals. • The service personnel must be appropriately trained and qualified. • If the OR table top is tilted (adjusted through the longitudinal axis), there is a danger that the patient will slip off. The patient must be sufficiently secured against slipping before the OR table top is tilted or otherwise moved out of the horizontal position! • Due to the physico-chemical properties of disinfectants, ensure that disinfectants do not accumulate beneath the patient. During use, the patient must not be moist or even wet when lying on the mattress. This presents a chemical burn hazard. • When RF surgical instruments or endocardial catheters are used, the patient must also be properly insulated. This insulation must not be damp. The equipment manufacturer’s instructions for use must be observed at all times. • With transdermal drug applications (patches), the additional heat can increase the uptake of the drugs and result in injury to the patient. • In the case of arterial occlusion, the applied parts of the ASTOPAD may not be used distal to this area. • Overheating of ischemic extremities can occur with the use of the ASTOPAD applied parts. • The ASTOPAD does not contain any parts the user can repair. Therefore, do not attempt to repair the ASTOPAD yourself. Contact your local sales point. • When applied parts ASTOPAD COV are used as a top blanket, ensure that they do not obstruct the patient’s field of vision.

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3 Important safety information

ASTOPAD® Instructions for Use

WARNING Risk of injury! • Do not use the ASTOPAD 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. - Damaged or missing markings/safety signs/warnings. - Damaged outer cover of the applied parts. - Alarm testing equipment defective. No optical or acoustic alarm after switching on using the Standby button (self-test). - Button(s) which do not function correctly. - A system that has been exposed to mechanical impact or liquid ingress into internal electronic system components. - A system that has previously delivered an electric shock to a person. - A system that appears to be overheating. • If at least one of the applied parts in a system triggers or has triggered an alarm shut-off. • If the self-test does not activate automatically after switching on with the Standby button and the heater does start operation immediately. • The extension connection cable and the mains cable should not touch the patient and should not hinder the treating personnel. • Any repairs and modifications to the equipment may only be carried out by persons authorised and qualified by the manufacturer. • Modifications to the ASTOPAD are not permitted. • The marked SENSOR ZONE of the ROE must not be covered by heat conducting materials. • If the ASTOPAD DUO control unit with installed battery is not used for a longer period, the battery must be removed. WARNING Risk of overheating! For infants and small children between 35 and 90 cm in height, use only the applied parts ASTOPAD COV070 and ASTOPAD SOF7. WARNING Risk of infection! • Use aseptic procedures. • Clean and disinfect the equipment after every use and before you return the equipment for repairs. • Route the extension connection cable between the applied part and the control unit in such a way that the cable is protected from mechanical damage. Prevent the cables from coming into contact with the floor. 9

ASTOPAD® Instructions for Use

3 Important safety information

WARNING Risk of decubitus ulcer! • Regardless of the treatment duration, aged, paralysed, comatose, and cachectic patients are particularly at risk of decubitus ulcers. Critical points should therefore also be constantly examined by medical personnel. • Do not fold, bend, or operate the applied parts in a folded condition. • Do not place the patient on the connection block of the applied part. • When the ASTOPAD COV applied parts are used as an under-blanket, ensure that they are placed flatly underneath the patient, are secured, and will not crease. • ASTOPAD COV applied parts can be wrapped around the patient. However, take care that the applied part will not form creases. 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 ASTOPAD DUO310 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 ASTOPAD DUO310 control unit and the applied parts of the ASTOPAD are undamaged. • The mains plug must be removed from the socket to fully disconnect the ASTOPAD from the mains.

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3 Important safety information

ASTOPAD® Instructions for Use

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 ASTOPAD, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

3.3 Cautions CAUTION Risk of injury! • When installing the ASTOPAD DUO310 control unit on an infusion stand, observe the instructions from the infusion stand manufacturer regarding maximum load and tilting stability. • When ASTOPAD is used on the OR table, the OR table must be prepared according to the customary regulations and guidelines. • Never insert pointed or sharp objects into the applied parts or damage the surface of the parts in any other way. • Damage to the Applied part can cause overheating, therefore: - Disinfect the heating profile with alcohol-based agents only. - Do not use bleach solution with hypochlorite for disinfection of the applied parts. - Other than the cleaning and disinfection procedures described in this IFU shall not be applied without the manufacturers authorization. CAUTION Risk of hypothermia! • If the alarm shut-off of the ASTOPAD is triggered at an output, the entire system will switch off. • If thermally conductive materials, such as water, gel, and similar substances, are used and were not pre-heated, the patient’s body temperature may reduce as a result once the ASTOPAD applied parts are switched off. • When the ASTOPAD is used, the patient’s body temperature must be monitored at regular intervals. • The temperature control of the ASTOPAD controls and monitors the temperature of the applied parts, but not the patient’s body temperature.

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ASTOPAD® Instructions for Use

3 Important safety information

CAUTION Risk of hypothermia! • If the ASTOPAD 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. • When this product is used in combination with other heat sources, an overheating alarm or an overheating alarm shut-off may occur on the ASTOPAD DUO310 control unit. CAUTION Risk of radio interference! • The essential performance can be lost or degraded due to EM disturbances. As a result, there is the possibility of hypothermia of the patient. • According 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. • The device/system can cause radio interferences or can interfere with the operation of devices in the vicinity. Appropriate measures may be necessary, such as reorienting or relocating of ASTOPAD or shielding.

3.4 Notices NOTICE • The specified moisture resistance IPX2 for the ASTOPAD applied parts is ensured only when the connector - Is connected to a suitable extension cable or - The attached protective cap is used. • Actions to avoid damaging the patient warming system: - Do not immerse the control unit and/or the applied parts in liquid. - Do not disinfect the system using steam (e.g., in autoclaves), hot air, or thermo-chemical cleaning solutions. - The applied parts must not be disinfected with bleach solution (hypochlorite or other agents containing chlorine). - The operator should not use any cleaning or decontamination methods other than those recommended by the manufacturer. • The customer is responsible for the proper packaging and labelling of returns. • The specified defibrillation protection is ensured only when the applied part is connected to the extension connection cable and the control unit.

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4 Specification of the application

ASTOPAD® Instructions for Use

4 Specification of the application 4.1 Intended use Patient warming system with reusable applied parts, which are used for body warming.

4.2 Intended medical indications The ASTOPAD patient warming system can be used in all areas used for medical purposes for prophylaxis against the patient cooling down or for treating hypothermia. Depending on their intended purpose, the individual applied parts can be used as over and/or under blankets or OR table pads; as well as for prophylaxis against cooling, the OR table pads are used to relieve pressure on the patient.

4.3 Contraindications The applied parts of the ASTOPAD COV/SOF/ROE must not be used for patients with a height of < 35 cm and/or in incubators.

4.4 Possible adverse effects In normal use, no side effects arising from ASTOPAD are to be expected. For longer surgical procedures there is an increased pressure ulcer risk for the patient. To reduce the pressure ulcer risk, therefore, the additional use of a pressure-relieving support is recommended after an operating time of two hours.

4.5 Intended patient population ASTOPAD COV/SOF/ROE applied parts: neonates, children, adults, elderly persons, except for patients with a height < 35 cm.

4.6 Intended user profile The device may only be used by qualified medical personnel.

4.7 Use environment • ASTOPAD may only be used in professional healthcare facilities (e.g. hospital, emergency care, dialysis, including HF surgical equipment, etc.). • ASTOPAD is not intended for home healthcare environment. • ASTOPAD is reusable, but requires cleaning / disinfection between the applications. • Appropriate medical hygienic factors must be applied for the use of ASTOPAD. • ASTOPAD must not be used in an environment at risk of explosion or in the present of flammable anesthetics. • The ASTOPAD can be used in surgical, intensive care or inpatient areas in which there is a risk of cooling for the patient, or where the patient requires external warming.

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ASTOPAD® Instructions for Use

5 Symbols

5 Symbols Symbols and indications on the control panel The Standby button switches between the Standby mode and the On mode. The device is in Standby mode if the blue LED illuminates. “Start” button: Starts the heating process. Temperature increase set value. Temperature decrease set value. “Stop” button. Alarm condition when the yellow LED flashes.

No applied part is connected to the control unit.

The applied part heats up to the set temperature. The applied part cools down to the set temperature. Battery capacity indicator. Defective or incorrect battery. Battery being charged or the device is connected to the mains.

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ASTOPAD® Instructions for Use

5 Symbols

Where applicable, these symbols appear at the appropriate location on the patient warming system, on the packaging, on the identification plate, or in the accompanying documentation. Defibrillation-proof type BF applied part in accordance with IEC/EN 60601-1. IPX2

Protected against dripping water in accordance with IEC/EN 60529. Follow the instructions for use. General warning/danger symbol. Catalogue number. Serial number. Batch code. Year of manufacture. Manufacturer. Information for the position of the locking ring on the cable plug of the extension connection cable. Battery Limits of the heated area. The SENSOR ZONE symbol marks the area containing the sensors for controlling the mattress temperature (applied parts of the ASTOPAD ROE). Symbol on plug connector for potential equalisation in accordance with IEC/EN 60601-1. Dry at low heat. Boil-proof, delicate wash cycle. Do not use chlorine bleach. Do not iron. Dry-cleaning possible, with limitation of mechanical stress.

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ASTOPAD® Instructions for Use

5 Symbols

Additional information Electrical devices are recoverable waste and should not be disposed of in domestic waste at the end of their service life. Batteries and rechargeable batteries are recoverable waste and should not be disposed of in domestic waste at the end of their service life. Symbol for the permitted temperature range for storage and transport. Symbol for the permitted moisture range for storage and transport. Symbol for the permitted atmospheric pressure range for storage and transport. Transport with the arrows pointing up. Keep dry. Fragile, protect against impacts. Packaging Labeling for the transport of lithium batteries according to ADR SV 188 or IATA - DGR International Dangerous Goods Regulations, Packing Instruction 965, II. SECTION II 43416

75JA

Labeling for individual shipment of lithium-Ion batteries via air freight according to IATA - DGR International Dangerous Goods Regulations, Packing Instruction 965, II. SECTION II II.2 Additional requirements 43418 / v4 This device conforms to EC Council Directive 93/42/EEC of 14 June 1993 concerning medical devices. The notified body, DEKRA Certification GmbH (registration number 0124), monitors the manufacturer’s quality management system. 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. 60601-1:14. Control No. 75JA Tilt of the OR table top. Acoustic alarm signal. No acoustic alarm signal.

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ASTOPAD® Instructions for Use

6 Product description

6 Product description 6.1 Introduction The ASTOPAD consists of a control unit and optionally one or two applied parts (warming blankets, pads, mattresses and OR table pads). The ASTOPAD may only be used in rooms designated for medical purposes. The relevant and applicable hygiene rules for the use of medical devices apply. The ASTOPAD is not intended for use in homecare, or veterinary medicine. The ASTOPAD can be used in surgical, intensive care or inpatient areas in which there is a risk of cooling for the patient, or where the patient requires external warming. All ASTOPAD applied parts may have direct skin contact (injured/uninjured skin) with the patient or may be operated with an intermediate layer between the part and the patient. WARNING Danger of overheating! For infants and small children between 35 and 90 cm in height, use only the applied parts ASTOPAD COV070 and ASTOPAD SOF7.

6.2 Technical description The ASTOPAD DUO310 is the control unit for the ASTOPAD and is equipped with a universal mounting clamp for attaching to standard medical equipment rails or an infusion stand. The ASTOPAD DUO310 control unit has two outputs (device sockets) A and B for connecting ASTOPAD applied parts. The desired Set-Temperature can be selected in the range of 32.0 °C - 39.0 °C in 0.5 °C increments for each connected applied part, independently of each other, on the control panel of the control unit. The control unit can also be used with only one of the output A or B. The selected Set-Temperature and the current temperature are displayed individually for each applied part in the control panel. With the battery option, the ASTOPAD DUO310 control unit can also be operated independent of the mains supply. When the battery is installed, it is possible to operate the device independently to the mains for approx. 2 hours. With the exception of the ASTOPAD COV155 and COV235 heating blankets, which were exclusively designed as blankets for the upper body, the applied parts of the ASTOPAD COV can be used as blankets for warming the patient from above, or as under-blankets for warming the patient from below.

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ASTOPAD® Instructions for Use

6 Product description

ASTOPAD SOF/ROE, the heated, pressure relieving operating table pad provides a unique combination of hypothermia and decubitus prophylaxis. The key component of the ASTOPAD SOF is a visco-elastic foam, combined with a dynamic foam base for the best possible decubitus prophylaxis on the operating table. ASTOPAD ROE, the special X-ray permeable applied part is based on an optionally 40 mm or 80 mm thick visco-elastic foam with a maximum sensor-free zone. Together with the pressure-relieving ASTOGEL gel pad, the ASTOPAD COV applied part plays an important role in the prevention of hypothermia and for pressure relief in surgical scenarios. The ASTOPAD COV must be laid over the ASTOGEL gel pad in order prevent cooling of the patient due to a cold gel pad. Heat is transferred to the patient immediately after the heating has been started. A long warm-up time for the ASTOGEL gel pad is not needed. However, it should be noted that only a combination of the ASTOPAD COV and ASTOGEL is permitted. The ASTOPAD DUO310 control unit does not control and indicate the actual temperature of the patient, but rather only the actual temperature of the applied part. Temperature regulation of the individual applied parts is performed with several integrated sensors. Safety of ASTOPAD is guaranteed by the following measures per output: • Several temperature sensors for each applied part • Double independent sensor monitoring • Heater monitoring • Time shut-off • Visual and acoustic alarm signals • Overheating and low-temperature alarm if the contact surface temperature deviates from the temperature controller setting

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ASTOPAD® Instructions for Use

6 Product description

6.3 Components of the ASTOPAD Control unit No.

Designation

1

Control panel

2

Attachment device

Description Operating buttons and temperature displays. For secure attachment of the ASTOPAD DUO310 control unit.

Output A (connecting socket) Output B (connecting socket)

Plug connection between control unit and applied part.

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Connector for Potential Equalization

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 operation between the body, the medical electrical devices and conductive parts of other objects. The connection is made by green-yellow insulated leads (min. 4 mm²) to standardized plug connectors and receptacles. When connecting/combining medical electrical equipment together to a medical electrical system, the requirements of IEC/EN 60601-1 must be observed.

6

Power input connector for removable power cord with mains plug

Conveys electricity from the wall power outlet to the control unit. Pull the mains plug to disconnect from supply network.

3 4

Fig. 1 Control unit

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ASTOPAD® Instructions for Use

6 Product description

ASTOPAD COV/SOF/ROE applied parts No. Designation 1

ASTOPAD COV

2

ASTOPAD SOF/ROE

3

Connection cable

4

End cap

5

Extension connection cable

Fig. 2 ASTOPAD COV/SOF/ROE applied parts

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Description Example of an ASTOPAD COV applied part. Example of an ASTOPAD SOF/ROE applied part. Connection cable for connecting to the extension connection cable. The attached end cap is used to close off the end when an extension cable is not connected. It protects the contacts and guarantees the IPX2 moisture protection. The extension connection cable is used to connect the ASTOPAD COV, SOF and ROE applied parts to the control unit.