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Instructions for use

ASTOPAD

Patient warming system

STIHLER ELECTRONIC GmbH



70771 Leinfelden-Echterdingen



Germany

DUO310
COV070
COV105
COV150
COV155
COV180
SOF2
SOF4
SOF5
SOF7
ROE4
ROE8

.12,

Содержание ASTOPAD COV070

Страница 1: ...tions for use ASTOPAD Patient warming system STIHLER ELECTRONIC GmbH 70771 Leinfelden Echterdingen Germany DUO310 COV070 COV105 COV150 COV155 COV180 SOF2 SOF4 SOF5 SOF7 ROE4 ROE8 0315 7200 12 Rev 08 0...

Страница 2: ...nfelden Echterdingen GERMANY Tel 49 0 711 720670 Fax 49 0 711 7206757 www stihlerelectronic de E mail info stihlerelectronic de 2021 STIHLER ELECTRONIC GmbH STIHLER ELECTRONIC GmbH declares under its...

Страница 3: ...le adverse effects 14 4 4 Intended patient group 14 4 5 Intended body part 14 4 6 Intended user profile 15 4 7 Intended environment of use operation 15 5 Symbols 16 6 Product description 20 6 1 Introd...

Страница 4: ...alarm shut off A4 medium priority alarm 47 10 5 Sensor defect alarm A5 medium priority alarm 48 10 6 Heating defect alarm A6 medium priority alarm 49 11 Information messages and troubleshooting 50 11...

Страница 5: ...handling use of force or damage caused by normal wear and tear This also applies to changes undertaken by persons who are not authorised by the manufacturer and to modifications to the original condit...

Страница 6: ...l 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...

Страница 7: ...c de 3 Important safety information These instructions for use define and refer to the following safety information DANGER Describes a risk from a situation which if not avoided will result directly i...

Страница 8: ...re carried out during opera tion servicing or repeated inspections The ASTOPAD may only be used by appropriately trained and medically qualified specialists The ASTOPAD may only be serviced by appropr...

Страница 9: ...safety signs warnings Damaged outer cover of the ASTOPAD applied parts No visual or audible alarm activated after switching on via the Standby button self test defective Button s which do not functio...

Страница 10: ...folded or bent under the patient Do not place the patient on the connection block of the ASTOPAD applied part When the ASTOPAD applied parts COV are used as an under blanket please ensure that they ar...

Страница 11: ...D control unit and the ASTOPAD applied parts are undamaged The mains plug must be removed from the socket to fully disconnect the ASTO PAD from the mains WARNING Risk of radio interference Use of the...

Страница 12: ...disinfection procedures other than those specified in this manual without the express permission of the manufacturer CAUTION Risk of hypothermia If an ASTOPAD alarm shutdown is triggered at one output...

Страница 13: ...sary to take appropriate corrective action such as a realignment a new configuration of the ASTOPAD or shielding 3 4 Notices NOTICE The specified moisture resistance IPX2 for the ASTOPAD applied parts...

Страница 14: ...decubitus ulcers the additional use of a pressure relieving pad is recom mended if the operating time exceeds two hours 4 4 Intended patient group ASTOPAD must not be used for patients with a height...

Страница 15: ...there is a risk of cooling for the patient or where the patient re quires external warming ASTOPAD is reusable but must be cleaned disinfected between uses The ASTOPAD control unit is designed to be...

Страница 16: ...set value Stop button Stops the heating process Alarm condition when the yellow LED is lit or flashing No ASTOPAD applied part is connected to the control unit Wait until the temperature of the appli...

Страница 17: ...ber Serial number Batch designation Medical device Year of manufacture Manufacturer Information for the position of the locking ring on the cable plug of the extension connection cable Battery Margins...

Страница 18: ...according to ADR SV 188 or IATA DGR International Dangerous Goods Regulations Packing Instruction 965 II SECTION II 43416 Labelling for the individual shipment of lithium ion batteries via air freight...

Страница 19: ...applied parts with pointed or sharp objects risk of damage and possible overheat ing Prohibited Do not disinfect with hypochlorite solution Chlorine and peroxides and all other oxidising disinfectants...

Страница 20: ...lso be operated with only one of the outputs A or B connected The selected set temper ature and the actual temperature of each applied part are displayed on the control panel The ASTOPAD control unit...

Страница 21: ...D is started A long warm up time for the gel pad is not needed ASTOPAD does not regulate the patient s actual body temperature and does not display it It only shows the current temperature of the acti...

Страница 22: ...potentials of various metal parts which can be touched at the same time or of re ducing potential differences that can arise in the application between the body electromedical equipment and foreign c...

Страница 23: ...d part SOF 3 ASTOPAD ROE Example of an ASTOPAD applied part ROE 4 Connection cable Connection cable for connecting to the exten sion connection cable 5 End cap The attached end cap is closed when no e...

Страница 24: ...5 Alarm indicator Displays the corresponding alarm code in an alarm situa tion 6 Start button Start LED green A or B Press this button to start the heating process or Press this button to confirm a ch...

Страница 25: ...Action After connecting the mains plug to the mains socket the con trol unit is in Standby mode Device re sponse The Standby LED 9 lights up The display 11 shows the symbol for battery status only fo...

Страница 26: ...n 12 is displayed for 1 second The equipment performs a self test The LEDs 6 10 flash once and the acoustic alarm signal sounds once to confirm that the control unit is working properly If no applied...

Страница 27: ...lf test The LEDs 6 10 flash and the acoustic alarm signal sounds to confirm that the control unit is working properly The display shows the current actual temperature 1 and the stored set temperature...

Страница 28: ...is loaded Acoustic alarm switches off and the alarm LED 10 goes out When the applied part is started the display 5 shows the applied part heating symbol until the difference with re gard to the set t...

Страница 29: ...es green until confirmation by press ing the Start button 6 The selected set temperature 2 is saved When the applied part is started the display 5 shows the symbol or until the difference with regard...

Страница 30: ...ED 6 goes out Displays 1 and 2 go off for the output that was switched off If only one output is active pressing the Stop button 7 will deactivate the heating process of this output and activate the s...

Страница 31: ...e level Control panel Action Operate control unit with one or two applied parts Device response Display shows the symbol battery charge level 1 100 Display shows the symbol battery charge level 2 10 7...

Страница 32: ...control unit again On mode 8 Installation 8 1 Initial start up Prior to first use perform the following inspections Visual inspection see Section 13 1 Recurrent tests Check the mains voltage compare t...

Страница 33: ...f 165 cm on the infusion stand ASTOSTAND 180 cm and place the opened clamping area of the fixing device on the infusion stand 3 Turn the handwheel clockwise to tighten the fastening device to the infu...

Страница 34: ...oose control panel Damaged or missing labels safety signs warnings Damaged outer cover of the ASTOPAD applied parts No visual or audible alarm activated after switching on via the Standby button self...

Страница 35: ...n the connection block of the ASTOPAD applied part When the ASTOPAD applied parts COV are used as an under blanket please ensure that they are placed flat underneath the patient are secured and will n...

Страница 36: ...table with the fixation straps of the cover so that it is flat underneath the patient and will not crease If combining a pressure relieving gel pad and an ASTOPAD applied part place the gel pad under...

Страница 37: ...at they do not obstruct the patient s field of vision Place the ASTOPAD applied part lengthwise over the patient with the cable con nection side facing away from the patient If areas of the patient ar...

Страница 38: ...pad without Velcro the applied part must be secured with the SOF45X fixation cover 1 Push the ASTOPAD applied part SOF into the fixation cover type plate on the blue side 2 Position the ASTOPAD applie...

Страница 39: ...e plug are facing upwards Secure the plug connection by turning it a quarter rotation to the right 6 Switch on the ASTOPAD control unit with the Standby button 7 Check whether the self test is automat...

Страница 40: ...d disinfecting chemical resistant Always work from top to bottom and from clean to dirty areas When using wipes only use for as long as they leave a closed film of fluid on the surface Please observe...

Страница 41: ...ohol based disinfectant or one of the approved disinfectants Do not use bleach solution containing hypochlorite to disinfect the ASTOPAD ap plied parts Do not carry out cleaning or disinfection proced...

Страница 42: ...according to the following procedure 1 Disconnect the ASTOPAD control unit from the mains 2 Visually inspect the control panel and the housing from all sides for wear holes cracks and other impermissi...

Страница 43: ...ry to the patient is delayed and the user has sufficient time to provide alternative warming methods To guarantee the safe operation of ASTOPAD for patients and users ASTOPAD is equipped with a series...

Страница 44: ...LED 6 flashes The alarm LED 10 lights up yellow An acoustic alarm signal is triggered Possible reasons Required action s The applied part is influenced by the environmental condi tions cooled Stop co...

Страница 45: ...e alarm LED 10 lights up yellow An acoustic alarm signal is triggered Possible reasons Required action s Set temperature was lowered Cooling phase no action necessary The applied part is influenced by...

Страница 46: ...ellow An acoustic alarm signal is triggered The heating process is not interrupted Possible reasons Required action s A layer of thermally conductive materials water or gel is situated on the applied...

Страница 47: ...ggered The heating process is interrupted at the two outputs Possible reasons Required action s Set temperature is increased Applied part produces a tem perature overshoot 1 Switch off the control uni...

Страница 48: ...coustic alarm signal is triggered The heating process is interrupted at the two outputs Possible reasons Required action s Defective sensor s in the applied part Send the applied part to the local sal...

Страница 49: ...gnal is triggered The heating process is interrupted at the two outputs Possible reasons Required action s Heater resistance too high or low Send the applied part to the local sales point Defective co...

Страница 50: ...Start screen in mains operation and in Standby mode the display 11 8 shows the crossed out battery symbol Required action s Insert new original battery The battery should be replaced every 3 years to...

Страница 51: ...11 3 Applied part temperature too high Control panel Information condition The actual temperature 1 is higher than 45 C Device response Display 1 shows H Possible reasons Required action s The actual...

Страница 52: ...LED Acoustic alarm signal Possible reasons Green Yellow Blue Standby mode Battery is charg ing Battery defective or no original battery inserted On mode Battery defec tive or no origi nal battery in...

Страница 53: ...ng process not started L Set temperature Warm up phase and actual tem perature 20 C Actual temperature Set temperature Cooling phase Mode Increase decrease set temperature Actual temperature Set tempe...

Страница 54: ...her than the set tempera ture for at least 10 minutes Time alarm A3 Actual temperature Set temperature A3 Set temperature not reached within 60 minutes of uninterrupted heating Overheating alarm shut...

Страница 55: ...nt Any repairs to the equipment may only be carried out by persons authorised and qualified by the manufacturer Modifications to the ASTOPAD are not permitted On request STIHLER ELECTRONIC GmbH will p...

Страница 56: ...ructions are included in the scope of delivery of the ASTO PAD system test box 13 2 Replacing the battery 1 Disconnect the ASTOPAD control unit completely from the power supply by pulling out the main...

Страница 57: ...g mode Continuous operation Permissible environmental conditions Moisture Temperature Atmospheric pressure In operation storage 10 to 75 non condensing 16 C to 26 C 700 hPa to 1060 hPa In transport 20...

Страница 58: ...37 0 C Approx 10 minutes Expected oper ating life The expected operating life is 5 years from the date of first use providing the product has not been subject to misuse negligence damage or inappropri...

Страница 59: ...E8 Power consumption W 105 Dimensions mm Length Height approx 2400 2800 40 approx 2400 2800 80 Weight kg Approx 6 5 Approx 13 0 Connection cable 200 cm PVC cable according to ordering information ASTO...

Страница 60: ...larm systems in medi cal electrical equipment and medical electrical systems IEC EN 80601 2 35 Medical electrical equipment Part 2 35 Particular re quirements for basic safety and essential performanc...

Страница 61: ...AD COV105 heating blanket 1050 x 500 mm COV150 ASTOPAD COV150 heating blanket 1500 x 500 mm COV155 ASTOPAD COV155 arm chest heating blanket 1500 x 500 mm with cutout COV180 ASTOPAD COV180 heating blan...

Страница 62: ...COV150 SOF407 Reusable cover for SOF7 SOF404 Reusable cover for SOF4 SOF405 Reusable cover for SOF5 SOF402 Reusable cover for SOF2 SOF457 Fixation cover for SOF7 SOF454 Fixation cover for SOF4 SOF455...

Страница 63: ...ure that the system is used in such an environment Immunity test Test level Compliance level Electromagnetic environment guidelines Electrostatic dis charge ESD ac cording to IEC 61000 4 2 8 kV contac...

Страница 64: ...ess the electromagnetic environment due to fixed RF transmitters a site survey is recommended If the measured field strength at the location in which the ASTOPAD is used exceeds the compliance level s...

Страница 65: ...17 Guidelines and manufacturer s declaration ASTOPAD Instructions for Use 65...

Страница 66: ...ASTOPAD Instructions for Use 17 Guidelines and manufacturer s declaration 66...

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