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ASTOPAD

Instructions for Use

ASTOPAD

Built-in, rechargeable battery for ASTO-
PAD DUO310 control unit (optional)

Type

Li-Ion

Energy level

99.4 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

Explosion hazard!

Do not use the ASTOPAD patient warming system in an explosion-hazard envi-
ronment or in the presence of flammable anesthetics.

Содержание ASTOPAD

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 59: ...ASTOPAD Instructions for Use 59...

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