STIHLER ELECTRONIC ASTOPAD Instructions For Use Manual Download Page 20 | Manualshive

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ASTOPAD

®

Instructions for Use

20

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 tempera-
ture deviates from the temperature controller setting

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Summary of Contents for ASTOPAD

Page 1: ...Instructions for use ASTOPAD Patient Warming System STIHLER ELECTRONIC GmbH 70597 Stuttgart Germany Part no 0315 7200 12NA Rev 01_draft 02 2020...

Page 2: ...n 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 i...

Page 3: ...omponents of the ASTOPAD 21 6 4 Control panel 23 7 Operating states 24 7 1 Standby mode 24 7 2 On mode 25 7 3 Heating mode output A and or B 26 7 4 Increasing decreasing the set temperature 27 7 5 Swi...

Page 4: ...ow 45 11 4 Applied part temperature too high 46 12 Brief overview of operating states and alarms 47 12 1 Overview of operating states 47 12 2 Overview of alarms 49 13 Maintenance 50 13 1 Recurrents te...

Page 5: ...age caused by normal wear and tear This applies also to changes undertaken by persons who are not authorized by the manufacturer and to modifications to the original condition If the equipment is dama...

Page 6: ...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...

Page 7: ...is located on the type label attached the control unit s rear and on the backside of the junction block of the applied parts 3 Important safety information These instructions for use define and refer...

Page 8: ...a chance 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...

Page 9: ...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 co...

Page 10: ...y promi nences DO NOT place any hard objects e g mattress cables ECG cables hard cautery return pads patient fluid lines etc between the ASTOPAD applied part and the patient ASTOPAD COV applied parts...

Page 11: ...he order of a Licensed Healthcare Practitioner When installing the ASTOPAD DUO310 control unit on an infusion stand ob serve the instructions from the infusion stand manufacturer regarding maxi mum lo...

Page 12: ...ty 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 opera tion of devices in the vici...

Page 13: ...ncreased pressure ulcer risk for the pa tient To reduce the pressure ulcer risk therefore the additional use of a pres sure relieving support is recommended after an operating time of two hours 4 4 In...

Page 14: ...care environment ASTOPAD is reusable but requires cleaning disinfection between the appli cations Appropriate medical hygienic factors must be applied for the use of ASTOPAD ASTOPAD must not be used i...

Page 15: ...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...

Page 16: ...inst dripping water in accordance with IEC EN 60529 Follow the instructions for use Caution Federal US law restricts this device to sale by or on order of a Licensed Healthcare Practitioner General wa...

Page 17: ...88 or IATA DGR International Dangerous Goods Regulations Packing Instruction 965 II SECTION II 43416 Labeling for individual shipment of lithium Ion batteries via air freight according to IATA DGR Int...

Page 18: ...e applied parts risk of damage and possible overheating Prohibition Do not disinfect with hypochlorite solution Chlorine and peroxides and all other oxidizing disinfectants have a negative impact on t...

Page 19: ...user operator The control unit has two outputs connecting 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 incre...

Page 20: ...he 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 i...

Page 21: ...rent 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...

Page 22: ...necting to the extension connection cable 3 End cap The attached end cap is used to close off the end when an extension cable is not connected It pro tects the contacts and guarantees the IPX2 liq uid...

Page 23: ...f 0 5 C 5 Alarm indicator Displays the corresponding alarm code in an alarm situation 6 Start button Start LED green A or B Press this button to start the heating process or Press this button to confi...

Page 24: ...nse The Start LED turns off The Alarm LED turns off The Standby LED illuminates The display shows the symbol for battery status only for device with built in battery After a power failure the device a...

Page 25: ...d the display shows the current actual temperature If no applied part is connected to one of the two outputs A B the corresponding display is turned off Display of the saved initial set temperature Fo...

Page 26: ...ns off When the applied part is started the display shows the symbol Applied part heating until the difference between the set temperature is 1 0 C The Start LED is green Temperature control is active...

Page 27: ...pressing the Start button When the applied part is started the display shows the symbol Applied part cooling applied part heating until the difference between the set temperature is 1 0 C The Start LE...

Page 28: ...ssing the Stop button will activate the self test Pressing the Start button can reactivate the heating process with the last set temperature setting 7 6 Storage transportation only for battery operate...

Page 29: ...this the device can be securely attached to infusion stands as well as to medical standard rails CAUTION Risk of injury When installing the ASTOPAD DUO310 control unit on an infusion stand ob serve t...

Page 30: ...tween the patient and the ASTOPAD applied part WARNING Risk of injury When RF surgical instruments or endocardial catheters are used the patient must also be properly insulated This insulation must no...

Page 31: ...ts 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...

Page 32: ...that the blanket is flat underneath the pa tient and will not crease If a pressure relieving gel pad is used in combination with the applied parts ASTOPAD COV070 COV105 COV150 COV180 on the OR table...

Page 33: ...o the operation field 9 2 Starting the heating process The operator should be positioned in front of the ASTOPAD control unit able to see easily the displays and operating elements 1 Plug the mains pl...

Page 34: ...ature decrease to raise or lower the selected set temperature in 0 5 C increments 2 Confirm the new set temperature by pressing the Start button 9 4 Switching off an output Press the Stop button to en...

Page 35: ...f the applied parts therefore the use of such disinfectants for routine disinfection is not recommended The lifetime of ASTOPAD components is significantly reduced by these disinfectants 9 6 1 Prepara...

Page 36: ...nd disinfecting is possible only when no damage exists Dam aged components should not be used 3 Visually inspect all surfaces for residues of body fluids and other soilings When soil or residues of bo...

Page 37: ...tants 10 Alarms and troubleshooting The ASTOPAD does not require continuous supervision by the operator but must be inspected at regular intervals depending on the condition of the patient For this th...

Page 38: ...Possible reasons Required action s The applied part has not yet reached the set temperature Warm up phase no action necessary Applied part defective Send the applied part to the local sales point Requ...

Page 39: ...s Required action s Set temperature is decreasing Cooling phase no action necessary Press the Start button to reset the alarm Set temperature is increased Applied part produces a temperature overshoot...

Page 40: ...if the set temperature is not reached during 60 minutes of uninterrupted heating Possible reasons Required action s A layer of thermally conductive materials water or gel is on the applied part Remov...

Page 41: ...n applied part sensor measures a temperature of 41 0 C Possible reasons Required action s Set temperature is increased Applied part produces a temperature overshoot 1 Switch off the control unit 2 All...

Page 42: ...ore sensors in the applied part are defective Possible reasons Required action s Defective sensor s in the applied part Send the applied part to the local sales point Defective connection cable on the...

Page 43: ...fect in the heating conductor in the applied part Possible reasons Required action s Heater resistance too high or defective Send the applied part to the local sales point Defective connection cable o...

Page 44: ...if an applied part is not connected to either of the outputs A B Possible reasons Required action s No application part connected Connect at least one applied part to one of the outputs A B The displ...

Page 45: ...rted Possible reasons Required action s Battery defective Insert a new original battery Not an original battery Insert a new original battery The battery should be replaced every 3 years in order to e...

Page 46: ...trol panel Device response The display shows an H Information condi tion This display appears if the temperature of the applied part is outside of the display range Possible reasons Required action s...

Page 47: ...ossible reasons Green Yellow Blue Standby mode OFF Standby mode Battery is being charged Defective or incorrect battery On mode Defective or incorrect battery No applied part connected Actual temperat...

Page 48: ...put not started L Set temperature temperature of the applied part 20 0 C Actual temperature Set temperature Cooling phase Actual temperature Set temperature Defective or incorrect battery Standby Incr...

Page 49: ...al temperature Set temperature A3 Set temperature not reached during 60 minutes of uninterrupted heating Overheating alarm A4 Actual temperature Set temperature A4 Actual temperature 41 0 C H Set temp...

Page 50: ...are not permitted On request STIHLER ELECTRONIC GmbH will provide service instructions that will allow properly trained and qualified persons to repair the parts of the device that the manufacturer h...

Page 51: ...esistance Alternative device leakage current Alternative patient leakage current The tests must be performed according to the specifications in the test instructions Scope of delivery of the ASTOPAD t...

Page 52: ...ied part type BF Classification MDD 93 42 EEC Class IIb Regulatory class as per FDA II Code UMDNS 10 414 COV Code GMDN 37329 Dimensions mm Height Width Depth max 300 155 130 Weight kg 2 0 without batt...

Page 53: ...maintained as intended ASTOPAD All applied parts Electrical connection 24 VDC Classification IEC EN 60529 IPX2 Permissible ambient conditions Humidity Temperature Atmospheric pressure In operation 10...

Page 54: ...4 Wh Dimensions mm Length x Width x Height 150 x 77 x 22 Weight 430 g NOTICE The specified defibrillation protection is ensured only when the applied part is con nected to the control unit DANGER Exp...

Page 55: ...e Supplementary standard Alarm systems General requirements tests and guidance for alarm systems in medical electrical equipment and medical electrical systems IEC EN 80601 2 35 Medical electrical equ...

Page 56: ...t optional Applied parts incl standard extension connection cable COV50200 COV070 NA ASTOPAD COV070 warming blanket 680 x 480 mm COV105 NA ASTOPAD COV105 warming blanket 1050 x 500 mm COV150 NA ASTOPA...

Page 57: ...e ASTOPAD should assure that it is used in such an environment Immunity test Test level Compliance level Electromagnetic environment guid ance Electrostatic discharge ESD IEC EN 61000 4 2 8 kV contact...

Page 58: ...F transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the ASTOPAD is used exceeds the applicable RF compliance level above the ASTO...

Page 59: ...ASTOPAD Instructions for Use 59...

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