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Tecotherm User Manual

1. nennnnnn eee 36 9 2 Mattresses thermally insulated hoses tubing e ennnnnnnnn 36 9 3 L G IDOFGTU ee ProDEG ak 36 10 Storage and Transport isriniissiiirjnini ika i ini ei ieda 37 10 1 Storage of the TECOTHERM NEO device nn seca nee 37 102 RPS OF MaN SSES oiie A 37 OS Ia E EEEE E E EEEE 37 Page 2 of 60 11 Alarm system malfunctions incident management 00000 38 11 1 System Alarm System Failure e nennnennennznnnnnnnnnnznnnnn nazz nn 40 11 2 emperature Alarm i centers ct ewieeascecueeaceeceeousetanseeancdecinaeeenaceuted 43 11 3 Flow rate alarm a a ka 46 11 4 Alarm Fluid level lOW L rr nr rr 49 11 5 Alarm MO Mains POWER issa iv rsncaesteesseaimeeecssnineorneemrindeuens 51 11 6 Fluid escapes from the TECOTHERM NEO System 2 ee 53 12 Service preventive maintenance Software Update seen 54 12 1 Service amp Maintenance nr r rr n nn rent 54 12 2 Replacement of fluid in the device near nee nee 54 12 3 Check calibration of temperature probes ss eennnnnnnnnnnnnennnena 55 124 i A o eee nee er eee 55 13 B a P asec AE E E EET A N 56 14 Technical Data TECOTHERM NEO Specification seen 57 15 EMC guidance for TECOTHERM NEO l ennennnnennnnnnnenznnnznnnna 58 Abbreviations U Instruction for Use BCT Body Core Temperature as measured via the Rectum or Esophagus using appropriate temperature probes SF Svstem Failure Mattress Aqua Wrap Mattress Page 3 of 60
2. HEALTHCARE TECOTHERM NEO MEDICAL EQUIPMENT for Thermo Regulation and Monitoring Instructions for Use Caution Federal law restricts this device to sale by or on the order of a physician Revision November 2015 Applicable for software version 062 02 16 and higher Inspiration Healthcare Ltd Gildor House West Street Earl Shilton Leicester Leicestershire LE9 7EJ UK T 44 0 1455 840555 F 44 0 1455 841464 E info inspiration healthcare com W www inspiration healthcare com Page 1 of 60 Contents and abbreviations page 1 l e cece sn tare cacao essed E E E E R 4 1 1 intended cece sane ceceseacescnece dadaanan ETNE A REENEN 4 1 2 Indications for USEC cc ccc cece cece cece cece ence rnnnn nn nn nn nn nn nrnnnnnnnna 4 1 3 Contraindications for Use mia kai je 4 1 4 GT PE eaa sates sensi E E a N E EESE a 4 2 Information for Customers Service 8 Technical support 5 3 Symbols Indications prccanaetnneannneieadnensenteaniuevntadncdngrsencsanteamcacteumeneens 6 4 Warnings amp Precaution etc resi dccsudieesddennkesaionnciesamaedanaenboeosscscses 7 5 Safety 8 Reliabilitv s sen nnnnnnnnnnnnnnnnnznnnnznnnzznnnznnnznnnzza 8 6 TECOTHERM NEO Operating Function L nn eennnnnnnnnnz 10 6 1 Fallback mode rr nn nn 10 7 TECOTHERM NEO Thermoregulation System 0ceeee es 11 7 1 TECOTHERM NEO Operating Modes c cece cece eee ee eeee ens 11 7 2 TECOT
3. ml volume containing circulating fluid This container is prepared and prefilled by the manufacturer ready for operation To ensure a safe operation and a proper fluid circulation prior to each treatment fill refill device and mattress properly and correctly Attention Do not use a partially filled mattress in hypothermia treatment A Procedures Preparation of fresh mattress e Check mattress for defects and damage e Place mattress horizontally spread onto a plane support table e Connect QDC couplings of hoses to the mattress QDC counterparts Then plug to the ports 6 at the device right lower front part see section 8 3 of this IfU Preparation of fill up set see also section 7 9 of this IfU e Check fill up set for defects damages amp leaks e Fill up fluid bottle with sterile water up to the mark 450 mi e After filling close bottle cap tightly Filling Refilling e Connect QDCs of the fill up bottle to the refill port QDC counterparts 7 at the device front face e Put TECOTHERM NEO device into operation see section 8 of this IfU e In Main MENU select desired Treatment Mode and start operation Page 33 of 60 e Now lift fill up bottle and turn it until cap is directed downwards Attention If Flow rate alarm appears ignore it or push key 15 to silence audible KA x N alarm AUDIO paused appears at the display e Fill up until air bubbles inside the fill up bottle disappear e Then disconne
4. 1 Preface 1 1 Intended Use The Thermo Regulation System TECOTHERM NEO is designed for controlled cold amp heat treatment procedures By means of a mattress cold and heat is provided to the patient depending on the therapy objective The operator should be familiar with the operation modes and capabilities of the TECOTHERM NEO Prior to use carefully read this Instructions for Use IfU Note The Manufacturer carries responsibility for basic safety reliability and capability of the TECOTHERM NEO system only when e local electrical installation fully meets the requirements of the IfU e operation is performed by authorized personnel e TECOTHERM NEO is operated according to the instructions and statements in this IfU 1 2 Indications for Use The TECOTHERM NEO is a temperature management system for pediatric patients indicated for controlling and monitoring patient s temperature through conductive heat transfer 1 3 Contraindications for Use A No general contraindications are known For possible adverse effects study the relevant treatment and therapy protocols Avoid direct contact of mattress with fresh or non closed wounds infectious areas areas with ulceration and abscesses rash and burns 1 4 Operators Profile TECOTHERM NEO is intended for use by healthcare professionals only Operating a TECOTHERM NEO requires e Experience in using life support and life sustaining equipment e Experience in using medical e
5. Mattress temperatures for Total Body cooling warming children up to 50 kg body mass Temperature constancy Temperature accuracy Body Core Temperature control range Hydraulic circulation system Fluid Reservoir capacity Fluid flow rate in operation Circulation System pressure Electrical power consumption Applied Parts Rectal Probes Skin Probes Adaptor cable for disposable rectal probe Cool Wrap TC MATT NEO Material Dimensions Volume Mass empty Cool Wrap TC MATT DISP Material Dimensions Volume Mass empty Page 13 of 60 412 C to 39 C 0 3 C 0 1 C 32 C 33 5 C 38 C Il 30 C 38 C sterile water approx 250 ml up to 300ml min with mattress up to 500 ml min short circuited max 0 5 bar lt 350 W mains 100 130V 200 240V 50 60Hz TCM1837A single use TC D RB2A reusable TC D SO6 RGA reusable TC989803162 601 reusable Reusable Manufacturer Inspiration Healthcare PUR polyurethane transparent 620 x 420 mm 300 350 mi fluid 155g Single Use Manufacturer Inspiration Healthcare PUR polyurethane coated 620 x 420 mm 300 350 ml fluid 220g 7 3 Modules and Main Components e Central Cooling Warming Module e Hydraulic Module for controlled circulation of fluid e Micro Computer controlled Operating and Control Board e MENU user interface e Display for visualization of MENU operations and treatment therapy scenario e Alarm and monitoring system
6. Attention Check immediately whether Temperature probe is correctly connected to the device and the patient The operator should check and analyze the temperature profiles in the DIAGRAM feature Look first at the temperatures in the upper part of the display and check whether indicated temperatures are corresponding to the treatment section temperature settings and are plausible and make sense Page 43 of 60 In all following cases 1 5 If possible replace TECOTHERM NEO device by a replacement unit or a spare unit Put new system into operation following IfU Case 1 There is no indication of patient temperature in the DIAGRAM feature Device immediately switches to FALLBACK MODE and a decision on the future progression of the mattress temperature is required Measure Check whether Temperature Probe is plugged correctly to the socket R If not rectify lf cause is eliminated rectal temperature reappears in the information box Observe display until measured temperature approaches the set temperature If no success probe may have a sensor break or is electrically short circuited In this event replace probe with a prescribed temperature probe correctly in the rectum of the patient secure it Plug the probe into socket R Observe temperature indicator at the display If still no temperature indication appears repeat procedure with another new probe If this still fails turn off the device see section 8 4 Contact
7. Programmable Complete Treatment Mode Servo controlled mode Il Servo Control Mode constant rectal temperature Ill Constant Mattress Temperature Mode Note The operator can permanenily follow the Body Core Temperature on the display screen Treatment Mode Programmable Complete Treatment Mode Servo controlled mode system is designed for cooling heating and regulating the temperature of the patient Treatment mode allows selecting and setting target Body Core Temperatures within a range 32 C to 38 C To start treatment follow and observe the instructions in the MENU NOTE All parameters can be changed from set position at ANY TIME should the need arise Changes will be stored on the TECOTHERM NEO and can be seen on later analysis In treatment mode all temperatures time dates are recorded logged and can be read out transferred to a USB stick see section 7 13 for the USB port Page 11 of 60 Treatment Mode Il SERVO CONTROL Constant Rectal BCT Temperature Mode Target Body Core Temperatures 30 to 38 C Each treatment section will result in the temperature being maintained until operator intervention To start treatment follow the instructions of the MENU Treatment section 1 Cooling Down or Warming Phase Treatment section 2 Maintenance Phase NOTE TECOTHERM NEO will not alarm the end of any section The operator must observe whether the intended time of treatment has elapsed Treatment Mode Ill NON SERVO CONTR
8. Should there be more entries than available lines the list automatically scrolls when the last or the first line is reached The function can also be used to simply display the graphics without actually exporting the data at the end To perform export plug an USB stick into the USB port 9 at the rear side of the device Then follow MENU instructions The operator gets a message on the screen notifying the user whether or not data export was successful After successful export unplug USB Stick 8 4 Stop operation Turn off device To stop or to interrupt operation turn back to the TECOTHERM NEO Main MENU Then push Arrow Key W to move to entry Power off and finally push button Select Page 32 of 60 TECOTHERM NEO Main Menu Highlight and Select Function Required A Servocontrolled complete treatment mode Servo control mode constant rectal temperature Constant Mattress Temperature Mode Alarmcheck Export treatment data Service Language Ser Nr 2010 08 01 y Rev 023 01 32 Select After a few seconds device is shut off NOTE Push button 1 is lit out dimmed as long as system is plugged to mains Only unplugging the mains will cause green push button light to turn off Disconnection from mains Unplug the cable cord from the mains shock proofed socket or from the rear socket 8 8 5 TECOTHERM NEO system Filling Refilling Procedures TECOTHERM NEOs hydraulic module is equipped with an internal fluid tank of 250
9. e Temperature probes Detailed software is implemented Indicators and operation key elements buttons are clearly arranged at the front panel Mains socket and sockets for USB are positioned at the rear side Figure TECOTHERM NEO Device s TO TECOTHERM NEC eo RI 53 Central Cooling Warming module The Central Cooling Warming module is a thermoelectric based unit which cools or warms the circulating fluid This module is controlled and monitored bv means of a microcomputer in the Control Board and supplied bv a modern efficient switching power supply It is fan cooled to remove heat produced by the Peltier elements It is operating exactly to reach the target temperatures adjusted by the operator and hold them constant according treatment protocol Page 14 of 60 A large display serves as the user interface MENU operations and treatment modes are visualized on the display screen The operator either selects confirms or modifies treatment modes treatment options operations and settings using MENU operation Arrow Keys to move to MENU entries Pushbuttons below the display screen enable performing instructions like Select Confirm Cancel Apply Start etc Currently selectable instructions and entries are highlighted turquoise Display with MENU TECOTHERM NEO Main Menu Highlight and Select Function Required Servo Control Mode constant rectal temperature A y Constant Mattress Temperature Mode l Alarm check Ex
10. If abnormal performance is observed additional measures may be necessary such as re orienting or relocating TECOTHERM NEO b Over the frequency range 150 kHz to 80 MHz field strength should be less than 3 V m Note on Radiated RE Interference field strength more than 3 V m may affect the Rectal Temperature control by causing erroneous Rectal Temperature measurements However TECOTHERM NEO is safe up to 10 V m Page 59 of 60 Recommended separation distances between portable and mobile RF icati OTHERM NEO are controlled Customer or user of the TECOTHERM NEO can help to prevent electromagnetic interference by maintaining at least minimum distance between portable and mobile RF communications equipment transmitters and TECOTHERM NEO as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and
11. TC D RB2A autoclavable Single Use Rectal Probe Type TCM1837A Adaptor Cable for TCM1837A 1C989803162 601 Reusable Skin Probe pediatric Type TC D S06 RGA with REDEL connector autoclavable NOTE Rectal probe and Skin probe connectors have their individually mating sockets R and S A Ensure correct connections Body core temperature BCT is measured with the rectal probe Ensure that the probe is correctly inserted in the patient and that it is properly secured Also ensure that the probe is properly connected to the TECOTHERM NEO socket marked R The second temperature probe reference probe is plugged to the TECOTHERM NEO socket It independently monitors a second patient temperature Figure TECOTHERM NEO with Temperature Probes Page 20 of 60 7 9 Fill up Set for Filling Refilling Sterile Water Fill up set is a 500 ml fluid container made of HD polyethylene or of polypropylene material marked every 50ml The cap has two connecting adapters made of polyurethane tubing equipped with male QDC couplings To fill up refill TECOTHERM NEO device male connectors are plugged into ports 7 in the device front panel section 7 3 Figure Fill up set Female connectors Non Return Valve Page 21 of 60 7 10 Mattress pictured on following page For transfer of cold and heat to a patient within total body treatment disposable wrap mattresses are used All have connector parts connecting them to the hoses limited to wo
12. and inform your local service Case 2 All temperatures are indicated Measured temperature deviates more than 0 5 C from the set temperature Note In treatment sections 2 Cooling phase and 3 Re warming phase a maximum deviation of 0 5 C is allowed alarm limit Example Indicated rectal temperature is lower than set temperature 33 5 C Measure Check whether rectal probe is placed in its correct position or slipped out completely or partially The more it is slipped out the lower the detected and indicated temperature approaching ambient temperature If slipped out place probe into correct position and secure it Example Indicated rectal temperature is higher than set temperature 33 5 C Measure Cooling capacity of the device may be reduced system is fan cooled Possibly free flow of air is restricted Check whether device is placed onto a soft layer or pillow etc which restricts free flow of air from the bottom of the unit If so place device onto a plain solid support Check whether distances to surrounding walls are at least 15 cm Page 44 of 60 Case 3 Check Mattress temperature indication lf mattress temperature is not indicated in the DIAGRAM feature the Control board cannot regulate to hold rectal temperature constant Measure Push key T3 Options stop treatment In Main MENU select entry Power Off using arrow keys and then push T3 Select Device is shut down Do not switch on the device again Contact your lo
13. arrow keys the operator can select entry Language and is led to a list of available languages English Deutsch Espanol After selection display screen promptly shows the Main Menu in the selected language Pushing arrow keys T4 and 16 you may select the operation treatment mode see section 7 1 Selected entry is highlighted turquoise After selection of a treatment mode Follow the Instructions in the MENU Page 29 of 60 Adjustment of treatment parameters treatment start In main menu select one of the treatment modes details see section 7 1 Programmable Complete Treatment Mode Servo controlled mode Il Servo Control Mode constant rectal BCT temperature IIl Constant Mattress Temperature Mode All treatment modes are specified by their respective menus Note Pay attention to the entries highlighted turquoise Entry instructions are requesting adjustment to treatment temperatures and times durations pushing the arrow keys A W once or repeatedly Having selected treatment mode and accepted default values or modified the relevant treatment parameters and having positioned the patient on the mattress press Start button Treatment begins In treatment modes and II the measured rectal BCT temperature must be within 29 C to 39 C Otherwise Start will be denied because rectal BCT temperatures outside this range are regarded to be unacceptable measured incorrectly Treatment is started TECOTHERM NEO is prog
14. closed loop circuit and instead switch into fallback mode Different criteria apply during treatment phases when the patient s temperature is to be gradually adjusted at a pre determined speed It is Known that in this case the mattress temperature will gradually change at the same speed albeit with a certain delay with regard to the pre determined Body Core Temperature In practice however the mattress temperature will not always need to be exactly 1 above the BCT and depending on the patient it may be even higher as well as lower than the BCT User Defined Treatment Profiles Within Servo Control Complete Treatment Mode the user can set and store up to 9 user defined Treatment Profiles When changes are made to the default temperatures or times before the start of treatment the user is given an option to save this new settings as a treatment profile If selecting this option the new settings will get the next free treatment profile number 1 to 9 for identification If the starting point for the changes was a previously generated treatment profile it can be redefined instead of creating another new treatment profile After a treatment profile has been saved there is a further option to Store this profile as a future default Once the user has created at least one treatment profile when selecting the Servo Control Complete Treatment Mode in addition to the displayed temperatures and times corresponding to the profile d
15. people Page 60 of 60
16. procedure Figure Connection to ports Unlocking Keys o LET Note To unlock push metallic unlocking keys downwards A Place completely filled mattress onto a 10 20 mm thick plastic foam material that has good thermal insulation e g in a prepared incubator Page 2 of 60 Connecting Temperature Probes to TECOTHERM NEO device NOTE For treatment modes and Il a rectal probe is required NOTE Ensure that only correct probes are used AN Patient temperature measurement must be accomplished only with probes approved by Inspiration Healthcare Limited or the Authorized Representative Only these have been tested as required and ensure a sufficiently accurate and reliable temperature measurement even in an unfavorable electromagnetic environment Using other temperature probes could put the patient at risk Reusable Rectal Probes pediatric Rectal Probes pediatric Type TC D RB2A autoclavable Single Use Rectal Probe TCM1837A Adaptor Cable for use with TGM1837A 1C989803162 601 Reusable Skin Probe pediatric Type IC D SO6 RGA with REDEL connector autoclavable NOTE Rectal probe and Skin probe connectors have their individually mating sockets R and S A NOTE Not all accessories will be available in all markets due to regulatory compliance If patient is prepared for treatment Ensure that the rectal probe is correctly plugged to its socket R Probe must be correctly inserted in the patient and properl
17. surface to ensure free outflow of the cooling air e Do not place the device into small cabinet or onto small scale boards e Do not cover the device e The unit should be placed to avoid blowing air towards the patient e The unit should be placed so that visual alarms are clearly seen and acoustic alarms are clearly audible e Do not place mattresses and hoses onto hot or warm surfaces during operation e Do not operate the device near intensive heat sources Page 8 of 60 Attention Leave enough space around the TECOTHERM NEO so as not to obstruct passage of personnel Ensure that hoses cable cord temperature probes etc do not form obstacles e Ensure that placement of TECOTHERM NEO does not create hazards for hands and fingers or any other injuries e Check mattress for visible damage e Note Place mattress onto a 10 20 mm thick foam material that has good thermal insulation during operation Using an incubator A When using an incubator to perform treatment e Ensure there is enough space to properly place mattress Otherwise kinking of tubing may occur e Place the hoses with as few bends as possible Fasten the hoses in such a way to avoid kinking of the tubing near the mattress Note Place mattress onto a z 10 20 mm thick foam material that has good thermal insulation during operation Note Do not put mattress directly onto compact silicon inlays used in incubators Attention Ensure that incubator heaters are shu
18. the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3V d 1 2VP IEC 61000 4 6 150 kHz to 80 MHz d 1 2VP 80 MHz to 800 MHz Radiated RF 3 V m 3 V m IEC 61000 4 3 80 MHz to 2 5 GHz d 23VP 800 MHzto2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field strength from fixed RF transmitters as determined bv an electromagnetic site survey 2 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol R NOTE 1 At 80 MHz and 800 MHz the higher frequencv range applies NOTE 2 These guidelines mav not applv in all situations Electromagnetic propagation is affected bv absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoreticallv with accuracv To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location the TECOTHERM NEO is used exceeds the applicable RF compliance level above the TECOTHERM NEO should be observed to verify normal operation
19. 4 is activated and lit up brightly green audible alarm of higher sound intensity is generated The alarm can be silenced pushing key 15 AUDIO paused To continue treatment is impossible Contact your local service provider If possible Replace TECOTHERM NEO device by a replacement unit or a spare unit Put new system into operation start operation following appropriate Instructions for Use Page 51 of 60 Loss of mains power For the moment there is nothing to do Device will continue the interrupted treatment as soon as power returns TECOTHERM NEO is designed to continue operation in the previous treatment mode when mains voltage reappears If the interruption period was shorter than 60 minutes the previous system configuration will be restored and treatment continued The operator is asked whether to continue the interrupted treatment or not see MENU screen picture below If yes the log files created before the power loss will be continued too TECOTHERM NEO Power failure during treatment do you wish to continue with previoustreatment Confirm to continue with Yes or Start a new treatment with No If you wish to continue the interrupted treatment confirm YES Otherwise to start a new treatment push key Ti NO With NO you enter the Main MENU where you can shut down the device as well Page 52 of 60 11 6 Fluid escapes from the TECOTHERM NEO System Also see section 11 4 of this IfU Attention Large amoun
20. 95 dip in Ur gt 95 dip in Ur typical commercial or hospital and voltage variations for 2 cycle for 2 cycle environment If the user of the on power supply input TECOTHERM NEO requires continued lines 40 Ur 40 Ur operation during power mains IEC 61000 4 11 60 dip in Ur 60 dip in Ur interruptions it is recommended that the for 5 cycles for 5 cycles TECOTHERM NEO be powered from a non interruptible power supply or a 70 Ut 70 Ur battery 30 dip in Ur 30 dip in Ur for 25 cycles for 25 cycles lt 5 Ur lt 5 Ur gt 95 dip in Ur gt 95 dip in Ur for 5 sec for 5 sec Power frequency Power frequency magnetic fields should 50 Hz be at levels characteristic of a typical magnetic field location in a typical commercial or IEC 61000 4 8 hospital environment NOTE Uris the a c mains voltage prior to application of the test level Page 58 of 60 Guidance and manufacturer s declaration electromagnetic immunity The TECOTHERM NEO is intended for use in the electromagnetic environment specified below The customer or the user of the TECOTHERM NEO should assure that it is used in such an environment Immunity test IEC 60601 test Compliance level Electromagnetic environment level guidance Portable and mobile RF communications equipment should be used no closer to any part of the TECOTHERM NEO including cables than the recommended separation distance calculated from the equation applicable to
21. HERM NEO System Information ss nnnennnnnznnnnnnennnn 13 7 3 Modules and Main Components sssssseeenennnzennnznnnzennnzennnzznzzza 14 7 4 Alarm System and Monitoring Features sse neennnenenzannnzznnzi 16 1 5 Indicators and Operation Key elements Display screen 17 7 6 TECOTHERM NEO Rear Face 18 7 7 Indicating Temperatures nee n nn n nn ren mnn nennnnna 18 7 8 External Temperature Probes ss nennnnnnnznnnnnnnnnnnanennnnnnnnnnnn na 20 7 9 Fill up set for Filling Refilling fluid Lss seen ad aa sete 21 710 Mattresses nr rr n rr rr nn re renennrnznzenznznni 22 7 11 MENU and the User Interface USB connection eeeeeeceeeee eee 24 7 12 Treatment Data Selection and Transfer USB Socket 5 25 8 TECOTHERM NEO System Putting into operation 2 sse nn 26 8 1 Initial Set up lnitial bl Ue 9 eee eee 26 8 2 Pre operation CHECK UP Ls sse nnnennnnzennnnnnnnnnnnnnnnrnnnnnn arr ranznnnnnnzz na 26 8 3 ee a a EE A aa 27 8 4 Stop operation T Urn off device 66 ccccceeeccccesceecssecceeseeecseeeeeeeeess 32 8 5 TECOTHERM NEO System Filling Refilling Procedures 33 8 6 Draining a Used i aira E EEA EE E E 35 8 7 Application of mattresses to patients nn nnnnnnnnnnen na 35 9 Hygienic Requirements L nennenn nn nrnr nanna nn n nn nn nn 36 9 1 Cleaning and Disinfecting TECOTHERM NEO
22. Main MENU the operator selects a Menu language entry Language see section 8 3 Entries at the MENU left side are accessible for the operator except entry SERVICE Access to entry SERVICE is only for service personnel using a password mA TECOTHERM NEO Main Menu Highlight and Select Function Required Servo control mode constant rectal temperature Constant Mattress Temperature Mode Alarm check N Export treatment data Service Language Power Off Ser Nr 2010 08 01 y L t V7 Rev 023 01 32 LEY ene WN LN C CD lt fi b lt REY REY EY Alarms and errors are indicated optically by ICON symbols TECOTHERM NEO Acheck of the internal functions has been performed and did not detect any malfunction Now the alarm functions will be checked Can you see the various Symbols and clearly hear the two alarm sounds Yes Page 24 of 60 Important entries instructions notes and failures are displayed as turquoise highlighted Pop Up Windows TECOTHERM NEO Acheck of the internal functions has been performed and did not detect any malfunction Now the alarm functions will be checked Can you see the various Symbols and clearly hear the two alarm sounds Important conditions and preconditions to perform treatments are displayed on the screen The operator has to Confirm or Cancel Servocontrolled complete treatment mode NOTE A rectal probe is re
23. OL Constant Mattress Temperature Mode When TECOTHERM NEO is run in the Constant Mattress Temperature Mode to change body core temperature an independent temperature measurement is required selectable mattress temperature range is 12 C to 39 C In Treatment Mode Ill the operator is fully responsible for performing and selecting a treatment procedure He has to select appropriate mattress temperatures and treatment times for cooling and re warming Attention Only the Mattress temperature is permanently displayed on the screen in the display feature LARGE SIZE NUMBERS Treatment Procedure Section 1 Cooling Start treatment following the MENU instructions Treatment section 2 Re Warming NOTE Patient body mass may severely influence the re warming The larger the mass the slower the re warming All temperatures time dates are recorded logged and can be read out transferred to a USB stick see section 7 13 USB port Page 12 of 60 7 2 TECOTHERM NEO Thermo Regulation and Monitoring system Information For the TECOTHERM NEO no ESSENTIAL PERFORMANCES have been determined TECOTHERM NEO is a light weight efficient and powerful Thermo Regulation and Monitoring system Options Dimensions Mass Weight Operation modes lI Ill Cooling Warming Normothermia 375 x 190 215 x 310 mm W x L x H 7 2 kg Servo Control Complete treatment mode Servo Control Constant Rectal Temperature Constant Mattress Temperature
24. ant Mattress Temperature 0 3 C 0 5 bar 500 ml min shorted up to 300 in use approx 250 ml Sterile Water Quick Disconnect Couplings Fill Up Set 100 130V and 200 240V 50 60 Hz max 350 W 5x20mm 250VAC slow high breaking capacity at 100 130V S 4A H at 200 240V S 2 5A H lt 400 uA 2 5 m with hospital grade plug 10 C 41 C 12 C 39 C optical and audible alarms Sound pressure level approx 63 dB Sound pressure level approx 57 dB Sound pressure level approx 57 dB Sound pressure level approx 57 dB Sound pressure level approx 57 dB A A A A A 5 C to 27 C 10 to 75 not condensating Class 1 Risk Class Il b Type BF IP 20 DIN EN 60601 1 DIN EN 60601 1 2 DIN EN 60601 1 6 DIN EN 60601 1 8 DIN EN 60601 1 10 DIN EN 60601 2 35 E F CE 0494 Device of Class for use with shockproof mains sockets Type BF applied parts Page 57 of 60 15 EMC guidance for TECOTHERM NEO Guidance and manufacturer s declaration electromagnetic emissions The TECOTHERM NEO is intended for use in the electromagnetic environment specified below The customer or the user of the TECOTHERM NEO should assure that it is used in such an environment RF emissions Group 1 The TECOTHERM NEO uses RF energy only for its CISPR 11 internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment CISPR 11 The TECOTHERM NEO is s
25. cal service provider Case 4 Check ambient conditions Check whether ambient temperature is too high exceeding 27 C This can be caused by an external heat or infra red radiation source within or near the incubator Remove causes as appropriate Observe rectal temperature It should reach the set temperature after some time lf measured rectal temperature continues to deviate from the set temperature the device is defective Push key T3 Options stop treatment In Main MENU select entry Power Off using arrow keys and then push T3 Select Device is shut down Do not switch on the device again Contact your local service provider If possible replace TECOTHERM NEO device by a replacement unit or a spare unit Put new system into operation following U Case 5 External heat sources below mattress Check whether a warming mattress like electrically heated mattresses in incubators is placed below the mattress Remove as appropriate Observe rectal temperature It should reach the set temperature after some time lf measured rectal temperature continues to deviate from the set temperature the device is defective Push key T3 Options stop treatment In Main MENU select entry Power Off using arrow keys and then push T3 Select Device is shut down Do not switch on the device again Contact your local service provider If possible replace TECOTHERM NEO device by a replacement unit or a spare unit Put new system into operation followi
26. ct bottle QDC from ports 7 e To remove residual air bubbles in the mattress via mattress tubing outlet move and swing mattress slightly after filling operation e Re fill the fluid bottle with sterile water and connect it again as described above Continue filling up until air bubbles inside the fill up bottle disappear again e f audible alarm is active silence it by pushing blue button T5 Close open Pop Up window if activated Continue TECOTHERM NEO operation for 1 min If within this time period alarm No Flow appears or reappears follow the instructions in the display Pop Up window End procedure as described above TECOTHERM NEO system is ready to start the intended treatment Refilling TECOTHERM NEO device during treatment TECOTHERM NEO device is put into operation mattress is correctly connected and treatment is properly running During treatment symbol Low liquid level appears Low fluid level may be caused by loss of sterile water Lack of fluid or low fluid level is indicated by the symbol appearing at the screen accompanied by an audible alarm Button 15 is lit blue A retill top up of fluid is required Proceed as follows 1 Push key 15 to silence audible alarm AUDIO paused 448 appears at the display 2 If not prepared fill the fill up fluid bottle with sterile water up to the upper mark 450 mil After filling close bottle cap tightly 3 Turn bottle until cap is directed downwards and keep in this or
27. drained from the mattress Disconnect mattress Disconnect Re fill bottle discard fluid 8 7 Application of mattresses to patients Dimensions Mattress TC MATT DISP TC MATT NEO 440 x 620mm Attention Do not kink hose set and tubing Do not fold mattress Kinking and folding will stop fluid circulation and hence cooling or warming operation of the TECOTHERM NEO system Alarm No Flow may appear For further details see section 11 3 Before applying to human body pay attention to the following items A e Use only mattresses specified by the manufacturer e Mattresses must not be touched with sharp or tipped objects due to risk of puncture damage Liquid may escape Attention Avoid direct contact of mattress with non closed A wounds infectious areas areas with ulceration and abscesses rash and burns Page 35 of 60 Application Place mattress horizontally spread onto a plain support Ensure that mattress and ports 6 are on the same level approximately e Place mattress onto a 10 20 mm thick thermally insulating layer for ensuring good thermal insulation during treatment 9 Hvgienic Requirements 9 1 Cleaning and Disinfecting TECOTHERM NEO Attention Prior to cleaning and disinfecting switch off svstem A and unplug from mains The external cleaning and disinfecting of the device including hoses should be performed using a damp sponge or cloth soaked with a liquid disinfectant or a spray disinfectant in combina
28. e 12 1 Service Maintenance To ensure and maintain safe and proper long term operation of the TECOTHERM NEO equipment regular system inspection by an authorized service provider is necessary The inspection has to be done in compliance with current local legal rules and regulations Inspiration Healthcare Limited recommends system check and calibration at least every 12 months A check of the basic electrical safety must be carried out and documented annually 12 2 Replacement of fluid in the device The sterile water fluid circulating in the TECOTHERM NEO system should be replaced and the system cleansed every 2 months It is recommended to perform the cleansing procedure using a Chlorine Dioxide tablet which is available from Inspiration Healthcare Limited The cleansing procedure is as follows A wear disposable gloves and discard them after completing this procedure Note A Chlorine Dioxide tablet 1 5 4ppm 1 5 4mg L is required for this process This tablet can be sourced locally or from the Authorized Distributor see p 5 of this U First drain the liquid from the inner container Disconnect hoses Connect the empty Re fill bottle instead with cap upwards Start mattress mode and wait until all liquid is in the bottle Ignore or mute any flow alarm or fluid level alarm Stop mattress mode Disconnect bottle discard fluid into a sink Secondly prepare the cleansing solution Pour 450 ml of sterile water into the R
29. e display The push button 15 will light up at the same time and may be used to switch the acoustic alarm to mute for a period of eight 8 minutes Alarm functions are all of medium priority No patient assigned alarms exist The alarm No mains power No system voltage has a sound level of dB A 63 approximately the other alarms of dB A 57 approximately Interruption of power supply does not influence or alter the alarm settings They are automatically restored when power is on and alarm cause persists Assignment of alarm functions to failures and conditions System alarm Internal system failure Temperature alarm System operation temperature deviation of more than 0 5 C from set temperature Pee Ue gs No flow No or very restricted circulation of the fluid Fluid level low Fluid deficit in the internal fluid container AUDIO paused No mains power No system voltage due to mains power failure Alarm No Mains Power appears when device operation is stopped due to lack of electrical power Hence this kind of alarm cannot be displayed at the display screen This failure is indicated optically by a separate LED lit indicator 4 at the device lower front side see section 7 3 and by a separate intensive audible alarm This alarm can be silenced finally pushing key T5 AUDIO paused Page 38 of 60 NOTE Whenever an alarm appears first push key T5 to silence audible alarm AUDIO paused is AN appearing at the displa
30. e fill bottle Add one Chlorine Dioxide tablet 1 5 4ppm 1 5 4mg L Close bottle cap tightly Wait until tablet is dissolved completely This may take half an hour shaking the bottle will speed up the process Thirdly Immediately after the tablet is fully dissolved Connect hoses with mattress to the device Connect the fill up bottle to the refill ports at the device front face Turn bottle until cap is directed downwards and keep in this orientation Start mattress mode and wait until most of the liquid is transferred into the device and rising air bubbles in the fill up bottle disappear completely Disconnect boitle discard rest of fluid into a sink e Let the cleansing solution circulate for 10 minutes e Stop mattress mode Page 54 of 60 After that drain the cleansing solution from the inner container just as described above Finally fill up the system with fresh sterile water Connect hoses with mattress to the device Pour in 450 ml of sterile water into the Re fill bottle Connect the fill up bottle to the refill ports at the front of the device Turn bottle until cap is directed downwards and keep in this orientation Start mattress mode and wait until most of the liquid is transferred into the device and rising air bubbles in the fill up bottle disappear completely Disconnect bottle e Letthe sterile water circulate for 5 minutes e Stop mattress mode Now the device can be used for another patient or stored up to 2 m
31. e provider Page 47 of 60 Case 4 Volume of circulating liquid slightly too little Level of fluid decreased Low Fluid Level alarm will not yet be activated Adding approx 100 ml liquid will restore circulation Proceed as follows see for details section 8 5 too Plug connectors of the fill up bottle to the refill port QDC counterparts 7 at the device front face Lift fill up bottle and turn it until cap is directed downwards Observe liquid level in the refill container After adding approximately 100 ml disconnect connectors Observe whether symbol No Flow disappears Should the problem persist stop treatment and contact your local service provider for assistance lf possible Replace TECOTHERM NEO device by a replacement unit Or a Spare unit Start treatment according to IfU Page 48 of 60 11 4 Alarm Fluid Level Low See also section 11 6 Alarm fluid level too low Little or no fluid in the container NOTE When alarm appears push key T5 to silence audible AN Zl alarm AUDIO paused appears at the display This alarm indicates a lack of fluid inside the inner container There are now 8 minutes to resolve the problem until AUDIO alarm will re appear Attention Check immediately whether liquid is escaping or was escaping from the device A Gheck immediatelv whether a leakage is in the mattress or hoses If a big leak or fluid volume is seen below or near the device immediatelv shut off the device Contac
32. eclared as standard the option to choose another profile will be offered The process of creating a treatment profile can be canceled at any time In any case the treatment will always be performed using the settings that are shown on the display at the time of pressing the Start button During treatment temperature and time settings can be changed if necessary by pushing the Options button However these changes cannot be saved in profiles during the course of treatment Page 10 of 60 7 TECOTHERM NEO Thermo Regulation System Components and accessories e TECOTHERM NEO device Applied part mattress Temperature probe with connector Hose set thermally shielded to connect application parts to the device Fill up set includes necessary components for filling re filling Electrical Power cord up to 2 5 m Warning Accessories specified for use with TECOTHERM NEO should not be used with other medical electrical equipment or systems Optional accessories e Fluid Emptying Aid for mattress e Storage boxes e Chlorine Dioxide tablets for routine cleansing available from device supplier Treatment temperatures are strictly limited e Body Core Temperature 32 C 38 C lower limit upper limit in the treatment modes and II e Mattress temperature 12 C 39C Device internal temperature alarm limits 10 C lower limit 41 C upper limit 7 1 TECOTHERM NEO operating modes Three treatment and operation modes of TECOTHERM NEO
33. he manufacturer Page 56 of 60 14 Technical Data TECOTHERM NEO Specification Options Dimensions Weight without accessories Central Cooling Module Treatment temperature control ranges Patient weight max Control Systems Control System Operating System MainTreatment Modes automatically automatically manually Temperature Constancy Hydraulic Circulation System System pressure max Flow rate without with mattress Internal Fluid reservoir capacity Circulating Fluid Connectors Couplings Fill Up Refill Electrical Parameters Supply Voltage Mains Power consumption Fuses 2 pieces Earth Leakage Current Mains Power Cord Patient Safety Alarms Lower Temperature alarm limit Upper Temperature alarm limit Set Temperatures lower limit Set Temperatures upper limit Alarm System 5 Channels Blink LED Alarm No Mains Alarm System Failure Alarm No or restricted flow Alarm Low fluid level Alarm Temperature deviation Ambient conditions Operation Treatment Ambient Temperatures Operation Treatment Relative Humidity System safety Protection class Standards Certificate Cooling Warming amp Normothermia 375 x 190 215 x 310 mm WxHxD approx 7 2 kg Thermoelectrically based module Mattress 12 C to 39 C Rectal BCT 30 C to 38 C lt 50 kg 1 Microcomputer hardware control 2 Microcomputer MENU system Servo Control Complete Treatment Servo Control Constant Rectal Temperature Const
34. ientation until the whole fill up procedure is finished 4 Connect QDC of the fill up bottle to the refill port QDC counterparts 7 at the device front face Check connection of QDCs of the fill up bottle to the ports of QDC counterparts Attention f alarm No Flow appears ignore it or push button 15 again 5 Refill until symbol disappears continue filling until rising air bubbles in the bottle disappear 6 Disconnect QDC connectors of the fill up bottle from the device lf alarm Low fluid level reappears repeat refilling procedure as described Page 34 of 60 Attention Frequent or permanent appearance of the alarm indicates a malfunction or system failure Please follow sections 11 4 and 11 6 Replacement of Sterile Water see section 13 3 8 6 Draining a used mattress First drain fluid from the inner container e Disconnect hoses Connect the empty Re fill bottle instead with cap upwards e Start mattress mode and wait until all liquid is in the bottle Ignore or mute any flow alarm or fluid level alarm e Disconnect bottle discard fluid and connect again as described Now drain fluid from the mattress Connect mattress to the refill port couplings 7 at the device front face turn mattress upwards Wait for about 1 minute until all the liquid is drained from the right half of the mattress Disconnect mattress and re connect with connectors swapped turn mattress upwards Wait for about 1 minute until all the liquid is
35. l Hazard Do not touch contacts Applied Part Type BF Consult Instructions for Use BCT Rectal Temperature Sensor socket Skin Temperature Sensor socket Key Turn On System failure Q 00 Be PBR Temperature Alarm Alarm No or restricted Flow N Alarm Low fluid level Symbol AUDIO paused No Mains Power separate LED indicator Internal System Failure separate LED indicator A Iii Page 6 of 60 4 Warnings amp Precautions A Warnings e Do not modify the TECOTHERM NEO in any way e Do not open the device Risk of electrical shock A e Repair and maintenance are restricted to authorized personnel only e The TECOTHERM NEO device must be plugged to the mains using shockproof sockets Mains voltage must be 100 130V or 200 240V with 50 60 Hz Use only cord supplied with the device or a medical grade approved equivalent cord not longer than 2 5 m e Caution During operation and treatment The operator must not A A simultaneously touch the patient and metallic device parts plug connector sockets fuse contacts grounded connected parts at the device rear e Both temperature probe sockets on the front of the device and the USB socket on the rear are marked with ESD warning symbols They are sensitive against discharge of static electricity their electrical contacts should not be touched with the fingers or tooling When connecting probes or USB stick to their sockets the following
36. lectrical equipment e Operator must be trained in the use of the TECOTHERM NEO before operating the device Note Operator should carefully check all set parameters for correctness before starting the treatment A Page 4 of 60 2 Information for Customers Service amp Technical support For Technical Support please contact Inspiration Healthcare Ltd e Phone 44 1455 840555 1 Fax 44 1455 841464 E mail info inspiration healthcare co uk Inspiration Healthcare Limited or authorized representatives will instruct the operation personnel prior to putting the equipment into operation Additional information technical support additional manuals may be requested from Inspiration Healthcare Limited and any authorized distribution partner Authorized Distributor in the USA Maxtec 2305 South 1070 West Salt Lake City Utah 84119 USA Phone 385 549 8070 Fax 801 943 6090 www maxtec com Manufactured for Inspiration Healthcare Limited by TEC COM GmbH Am Krummling 1 Eingang B D 06184 Kabelsketal OT Zwintschona Germany Serial Number 2013 07 01 100 130 200 240 VAC 50 60 Hz max 350 VA Class IP20 Made in Germany Fuses 5x20mm 250VAC 100 130V S4AH T4AH 200 240V S2 5AH T2 5AH Manufacturer TEC COM GmbH Am Krummling Eingang B D 06184 C Kabelsketal OT Zwintsch na Germany 0494 Page 5 of 60 3 Symbols Indications Important Information Attention Caution Warning Electrica
37. lid surface horizontally standing on feet Store in dry ambient conditions Mains cable Keep cable near by the device Put it into a separate plastic storage bag Close bag Fill up Set The empty set is supplied in a box or bag Put filled or partially filled set into the set box beside the basic unit Keep cap tightly closed to avoid leakage of coolant fluid Protect QDC couplings against mechanical damage Store in dry ambient conditions Hoses Hoses are supplied in a closed airtight plastic envelope or a closed box Keep it closed until preparing TECOTHERM NEO for operation Atter use disinfect hoses and put them back into the box or the plastic envelope Keep hoses near the device 10 2 Storage of mattresses Unused mattresses should be stored in the original box or package Store in a drv and dark environment Storage time for emptv fresh mattresses in the closed storage box or envelope should be no more than 3 vears 10 3 Transport TECOTHERM NEO is a light weight system with weight 7 2 kg when the fluid reservoir is full Carry it to move the device over short distances or use an appropriate trolley When carrying do not touch or damage display screen Page 37 of 60 11 Alarm system malfunctions incident management Five 5 alarm functions are activated during operations to indicate any malfunction of the system Alarms during operations are indicated by an acoustic signal and a corresponding symbol on th
38. lt 0 5 C color changes to GREEN Page 18 of 60 Servo controlled complete treatment mode Servo controlled complete treatment mode 36 4 33 4 Set Point 33 5 Set Point 33 5 Details Details Treatment mode Ill As long as measured Mattress Temperature deviates more than 0 5 C from the Set Point the mattress temperature is appearing RED So for example if Set Point is 30 0 C a measured temperature of 34 1 C is displayed RED Only when deviation is c 0 5 C color changes from RED to BLUE Constant Mattress Temperature Mode Constant Mattress Temperature Mode 34 1 30 2 Set Point 30 0 Set Point 30 0 Details Details 60 seconds after starting treatment in each of the main treatment modes the display feature DIAGRAM is changed to the feature LARGE SIZE NUMBERS Here shown for treatment mode II Servo Control Constant rectal temperature Servo control mode constant rectal temperature Servo control mode constant rectal temperature Set Temperature 33 5 Mattress Temperature 35 4 Rectal Temperature 33 6 Skin Temperature Constant rectal temperature for 01 34 hours 23 03 2010 08 55 42 l il a2 8 T A Il ji l 15 V e Set Point 33 5 Options Details Page 19 of 60 7 8 External Temperature Probes Patient Temperatures should be measured using approved calibrated Temperature probes TECOTHERM NEO applies a Rectal Temperature probe and a Skin temperature probe Reusable Rectal Probes pediatric Type
39. n and search for leakage If leakage is small and no spare components are at hand try to provisionally seal the leak as to finish patient treatment Close the small leak by means of an adhesive tape or appropriate plasters non permeable After finishing the treatment replace the defective part or replace the mattress You can either stop treatment or temporarily continue until the problem is finally resolved Contact your local service provider If there is a big leakage replace this defective component immediately Note Ifthe alarm repeatedly appears check mattress hoses connectors and tubing once again to detect if and where fluid escapes In such cases see instructions in this section 11 4 and 11 6 After finishing the treatment replace the defective mattress Attention After refilling the TECOTHERM NEO is ready for use Usually the added fluid has a different temperature than the system fluid Temperature alarm as described in section 11 2 may appear We recommend to push key 15 to silence audible alarm 1 AUDIO paused appears at the displav Within a few minutes the svstem will reach the set operation temperature alarm svmbols will disappear Also inspect flow of fluid near mattress fluid outlet to hoses If shrinking due to low pressure is visible fill up additional 50 ml fluid in the same manner as described before see section 11 3 Page 50 of 60 11 5 Alarm No Mains Power DEL No system voltage mains
40. ncerning the nature of the fault as well as providing instructions as to what measures need to be taken to eliminate the problem This text field will not disappear automatically even though the AUDIO alarm might have been silenced It must be closed using push button 13 this allows sufficient time for the information to be read and understood by the operator 11 1 System Alarm System failure system Alarm is caused by a serious internal failure Two 2 SF alarm features are used 1 Svmbol SF is displayed at the screen display feature DIAGRAM accompanied by acoustic alarm 2 system alarm SF LED 5 in the lower part of the front panel The LED pictogram is activated accompanied by acoustic alarm Caution System failures will not be reset automatically A Device cannot be used in this error state Page 40 of 60 We draw your attention to a very rare event A Svstem alarm can be released accidentiv Svmbol is appearing at the screen 1 Step Unplug mains connector from the device socket at rear side gt TECOTHERM NEO is switched OFF Wait 5 seconds Plug mains connector back to the device socket gt TECOTHERM NEO is switched ON lf System alarm disappears continue treatment Note Previous treatment continues normally after confirming Yes at the screen appearing when power returned TECOTHERM NEO Power failure during treatment do you wish to continue with previous treatment Confirm to continue with Yes o
41. ng U Page 45 of 60 11 3 Flow rate alarm Flow rate alarm Insufficient circulation of cooling fluid Maintenance of the treatment temperature is no longer guaranteed An acoustic alarm will sound and a Pop Up window will inform the operator what actions need to be taken in order to restore normal circulation Example Constant Mattress Temperature Mode Set Temperature 28 0 Mattress Temperature 28 2 Rectal Temperature 34 2 SkinTemperature Constant mattress temperature for 00 43 hours Ss Caution We recommend to first pause the acoustic alarm A bv pressing the lit up push button 15 Please study the instructions for the correction of errors carefully and then close the text display window The diagram will reappear and the icons will remind you that although the acoustic alarm has been switched to mute the error still remains Constant Mattress Temperature Mode Set Temperature 28 0 Mattress Temperature 28 2 Rectal Temperature 34 2 Skin Temperature Constant mattress temperature for 00 43 hours 23 08 2011 08 55 42 4 hour Options The alarm will be muted for 8 minutes following which the acoustic alarm will be activated again Although the acoustic alarm can be switched again to mute the problem remains and needs to be resolved As long as this state of alarm does exist the unit is no longer able to regulate the patient s temperature in the required manner Page 46 of 60 in No or verv limited circulati
42. ntinues operating with the set parameters unless operator silences audible alarm pushing key 15 AUDIO paused Then another 10 seconds later the Control Board will switch off the device The operator can now analyze the situation and make an attempt to restore device operation by turning it ON again In any case subsequently contact your service partner Page 42 of 60 11 2 Temperature alarm Temperature alarm The display changes from Temperature indication LARGE NUMBER to DIAGRAM feature indicating the alarm symbol Audible alarm also appears Servo controlledcomplete treatment mode Servo controlled complete treatment mode Set Temperature 33 5 Mattress Temperature 396 8 Rectal Temperature 32 7 Skin Temperature Elapsed time of cooling phase 02 34 of 72 hours 23 03 2010 08 55 42 a EX ond f E TA IIII II FABRI a GU l Set Point 33 5 EE oe Details Options Current Measured Temperature Temperature alarm alarm paused Caused by Temperature probe disconnected from the device or sensor break Temperature probe is detached from patient System operation temperature deviates more than 0 5 C from set temperature Mattress temperature incorrectly measured Fan cooling insufficient Power of Central Cooling Module insufficient NOTE When alarm appears push key T5 to silence audible A alarm AUDIO paused appears at the display There are now 8 minutes to resolve the problem Elimination Management
43. on flow of the fluid Alarm indicates that for more than 10 seconds mattress gets too little fluid or flow is verv low due to blockage or there is too little fluid in the mattress Possible causes mav be 1 Pump is not working or with insufficient power 2 Kinkingof hose set and or tubing near mattress mattress folded couplings disconnected 3 Flow blocked small blocking obstacles in the couplings or tubing 4 Lack of circulating fluid slight deficit There are now 8 minutes to resolve the problem Elimination Management Case 1 Pump is defective not working system alarm is additionally appearing at the screen Proceed as described in section 11 1 Stop treatment shut off the device Push key T3 Options stop treatment In Main MENU select entry Power Off using arrow keys and then push T3 Select Device is shut down Do not switch on the device again lf possible replace TECOTHERM NEO device by a replacement unit or a spare unit Put new system into operation following U Contact your local service provider for inspection of the defective device Case 2 and 3 Inspection for kinking or blocking lf kinking of tubing or folding of mattress is observed resolve Disconnect all couplings and re connect them Reverse flow direction in hoses and mattress by interchanging the 2 male couplings of hoses in ports 6 Replace hoses if indications of flow blocking are found If problems remain contact and inform your local servic
44. on to power the device on marked 1 2 Temperature Probe Socket Skin Probe e Temperature Probe Socket Rectal Bodv Core Temperature Probe ee LED Indicator Mains Failure LED Indicator System Failure SF Pushbutton for MENU operations meaning indicated on display O1 Pushbutton for MENU operations meaning indicated on display Pushbutton for MENU operations meaning indicated on display Pushbutton A Arrow Key menu upwards or increase value Pushbutton Pausing Audible Alarm Pushbutton Female Coupling socket for connecting hoses or mattresses Se ee ee 242 DGG Arrow Key menu downwards or decrease value mmm A A A A A A mm ms AA Female Coupling socket for connecting fill up set Page 17 of 60 7 6 TECOTHERM NEO Rear Face Caution Federal law retris this device qale by oron the order ota physician 8 Mains Socket 9 USB socket 7 7 Indicating Temperatures Running the 3 main treatment modes treatment temperature is shown on the screen in a large size display feature LARGE SIZE NUMBERS Rectal temperature is displayed when selecting treatment mode I or Il Mattress temperature is shown when selecting treatment mode Ill Treatment modes and Il As long as measured temperature deviates more than 0 5 C from the Set Point the temperature is appearing RED So for example if Set Point is 33 5 C a measured temperature of 36 4 C is displayed RED Only when deviation is
45. onths 12 3 Check calibration of temperature probes We recommend checking and calibration of the reusable temperature probes within every 2 years in accordance with Technical Specification Manual of the temperature probe manufacturer 12 4 Software Update Ensure that the TECOTHERM NEO applies latest software versions Customers will be informed of software updates by Inspiration Healthcare Limited or authorized service provider Software update should be performed by service personnel Error in the update process is indicated at the display screen of the MENU in a Pop Up window highlighted turquoise see below If possible additional instructions will be displayed how to further proceed Export all log data Page 55 of 60 Back Select Service Highlight and select service option Change password sometimes there may be an only partial update TECOTHERM NEO system then will reboot This is not an error but only an information that it was intended to update only some not all components of the software Service Highlight and select service option Change password If necessary customer should consult Inspiration Healthcare Limited or Authorized Service Representative for assistance and support 13 Disposal This device must not be disposed of as common industrial or household waste It must be delivered to a local regular collecting point to a waste disposal company or returned to the distributor or t
46. plied AN bv the manufacturer Otherwise proper and safe operation cannot be guaranteed e Check that only sterile water is used as circulating fluid A e Check mattress for visible damage e Check whether the correct temperature probe is prepared Its connector must match the socket R at the device front panel e Without rectal temperature probe plugged to port R it is A not possible to start treatment modes and Il If all of these preconditions are fulfilled the device can be put into operation Page 26 of 60 8 3 Initial Operation lf mattress is positioned in an incubator read notes in section 5 Plug the cable cord into rear socket 8 Then plug the system to the mains into shock proofed socket Fuse data see section 13 Technical Data and type label Note Immediately after plugging to mains TECOTHERM NEO is in its Stand by mode Key 1 is lit green Next Step Connect mattress to the TECOTHERM NEO Prior to connecting check whether e mattress is filled completely If empty or only partially filled see section 8 5 for filling instructions e defects like punctures and flaws are possible If fluid escapes replace defective mattress e tubing is kinked or likely to kink Connect QDC couplings of hoses to the QDC counterparts of the mattress Then plug to the ports at the device right lower front part see figure If they do not engage properly push metallic unlocking keys at the QDC then repeat plug
47. port treatment data Service Ser No 2010 12 01 Rev 024 02 05 Page 15 of 60 7 4 Alarm System and Monitoring Features Alarm symbols shown on the display are indicating system errors and failures System failure SF Temperature Alarm Alarm No or restricted flow Low fluid level Audible alarm paused TECOTHERM NEO is equipped with detailed alarm and monitoring elements Main purpose is monitoring and detection of temperatures and flow of the circulating fluid of internal temperatures in the Central Cooling W arming module of the temperature limits mains power failure When detecting deviations from the limits and or failures the alarm system initiates optical and audible alarms and the above shown indicators appear on the screen Details on indicators see section 7 5 Mains Power failure a and certain internal system failures are indicated by LED indicators in the lower front panel just below the display screen For details see section 11 Alarm System Mains Cable Cord TECOTHERM NEO is powered via a medical grade cord to a shock proofed mains socket with 100 130V or 200 240V and 50 60Hz Cord should be up to 2 5 m long and approved for shock proofed sockets only Page 16 of 60 7 5 Indicators and Operation Keys Display screen Figure TECOTHERM NEO front panel view 14 Paine R 7 T5 IRLCOITHERM NEEC T6 T 1 Tey TA o m 1 6 d SF 8 194 m Pushbutt
48. power failure Accompanying audible alarm with higher sound intensity Device operation is stopped display is dark This failure is indicated optically by a separate LED lit indicator 4 at the device lower front face see section 7 3 and by a separate intensive continuous audible alarm The alarm can be silenced pushing key T5 AUDIO paused Caused by No supply from the mains Accidental shut off of the system Disconnected mains cable Blown fuses Internal defect in the TECOTHERM NEO device Elimination Management Check whether key 1 is lit slightly green If not lit TECOTHERM NEO is disconnected from mains grid lf only the TECOTHERM NEO device is shut off and no other equipment in the room check that cable cord is correctly plugged to the mains socket and to the device rear socket Fuses Check fuses Fuses are located in a small compartment of the device socket Unplug mains cable and pull out the small fuse compartment Replace the defective fuses Fuse types and ratings are indicated on the device rear plate type label and in the Technical Specification at the end of these Instructions for Use Note If fuse blows again stop operation Contact your local service provider Internal defect in the TECOTHERM NEO device lf the Switching Power Supply SPS fails or the SPS is not supplying the internal operating voltages 5 VDC and 24 VDC TECOTHERM NEO will stop operation Display will not operate dark LED Indicator
49. precautionary procedure is required Before plugging touch the fan protective grid at the rear with your other hand e Fora reliable and safe operation use only original components applied parts and spare parts supplied or recommended by Inspiration Healthcare Limited or the Authorized Representative e Only Sterile Water should be used as circulating fluid e Use only temperature probes in accordance with U and with the technical specification of the manufacturer Applying different probes may lead to incorrect and wrong temperature data This is likely to put patients at significant risk e Ensure that probes are properly connected to the TECOTHERM NEO socket marked R for Body Core Temperature and S for Surface Temperature e Ensure that Rectal and Skin Temperature Probes are correctly placed in on the patient and are properly AN secured e Do not use TECOTHERM NEO with or in presence of flammable agents Page of 60 5 Safety amp Reliability Warning Substitution of original parts or components of the TECOTHERM NEO system by parts or components which are not licensed by Inspiration Healthcare Limited or the Authorized Representative is likely to put the system and the patient at risk Precautions Notes Therapeutic Induced Total Body cooling is a systemic treatment method Select target temperatures cautiously Re warming Select low re warming rates to smoothly reach normal BCT of 37 C Patient bod
50. quired to be inserted prior to treatment Please ensure its correct placement prior to starting treatment For reference an additional skin temperature probe is strongly recommended Please confirm the requirement for a rectal probe by pressing the Confirm button Cancel Confirm 7 12 Treatment Data Selection and Transfer USB socket To read out and export treatment data and data log files select Entry Export Treatment Data in the Main MENU To perform export plug a USB stick into the USB port 9 at the rear side of the device Then follow MENU instructions The operator gets an indication on the screen whether data export was successful After successful export unplug USB stick Page 25 of 60 8 TECOTHERM NEO System Putting into Operation 8 1 Initial Set Up Initial Operation The manufacturer or authorized service personnel should initially set up the TECOTHERM NEO system The operators should be trained how to run the system 8 2 Pre operation Check Caution Ensure that power cord matches the shockproof A socket at site 100 130V or 200 240V 50 60HZ Caution Ensure that correct temperature probes A have been prepared and prepositioned Caution Ensure mattress has been prepared and prepositioned Prior to putting the svstem into operation check the conditions of section 5 to ensure safe and proper operation Warning For a reliable and safe operation use only original components and applied parts mattress sup
51. r Start a new treatment with No No Yes lf System alarm remains or appears again after a short time gt Shut off device by unplugging Mains cable Page 41 of 60 symbol System Alarm is displayed at the screen Caused by Failure in the TECOTHERM NEO system Defective Central Cooling Module Defective pump Temperature exceeding internal limits Communication problems between Operational System and Control system Measures Stepi has been carried out but did not solve the problem Shut off device by unplugging Mains cable Or Push key 13 Options end treatment and return to the Main MENU Pushing key T6 select Power Off and turn off device NOTE Device cannot be turned back on TECOTHERM NEO Main Menu Highlight and Select Function Required Servocontrolled completetreatment mode Servocontrol mode constant rectal temperature Constant Mattress Temperature Mode Alarmcheck Export treatment data Service Language Ser Nr 2010 08 01 y Rev 023 01 32 Select Device cannot be used Contact your local service provider for assistance If possible replace TECOTHERM NEO device with a spare unit Put it into operation according to IfU System Alarm Alarm feature 2 LED 5 in the lower part of the front panel is activated In case a serious communication error between Operational Board and subordinated Control Board after 10 seconds the Control Board creates an acoustic alarm and SF LED 5 is lit System co
52. rammed to reach target temperature as soon as possible if no other rate input is chosen by the operator time to reach final temperature gt 0 h The operator may observe the temperature time profile in the display feature DIAGRAM and actual temperature values in the small parameter boxes in the upper part Independent of treatment mode feature DIAGRAM changes after 60 seconds automatically to feature LARGE SIZE NUMBERS Page 30 of 60 Treatment is running Treatment is running according to and depending on selected treatment mode and applied treatment parameters All treatment data like temperatures time dates are automatically recorded logged and can be read out transferred to a USB stick During treatment the operator should from time to time monitor patient temperatures This is especially important during transition from cooling section 3 to re warming section 4 NOTE All parameters can be changed from set positions by pushing key 13 Options and selecting entry Change the current settings see below Pushing T1 Back returns the system to its original settings Options during operation Thecurrent operation continues to run Highlight and select the desired option A Immediately start the re warming phase Endtreatment and save data Alarmcheck Back Select End treatment When treatment approaches the end the operator may continue with a treatment Otherwise following the MENU instructions he is reque
53. rking pressure lt 0 5 bar The working pressure is limited to lt 0 5 bar For positioning the mattress use the felt fixation tapes Tapes are fed through eyelets at right and left sides of the wrap then forming a loop Both tape ends are knotted The operator may select by choosing the appropriate loop length to what extent the patient is wrapped Page 22 of 60 Page 23 of 60 00000 ooo aaea 0 0 0 0 000 o o o o ofo o oo 000 o oo o o ooo 000 See e abe 6 b ooo 0 0000 0 0o00o0 00000 0 ooo 0 000 0 o o o 0f j0 0 0 0 ooo ooo o O O O OJO O O OJo o ooo ooo o ooo oo 0 000 0 ooo 0 0000 0 O Om0 000 0 ooo 000000 0000000 Oy 40 1 mm 7 11 MENU and the User Interface USB connection TECOTHERM NEO provides a comfortable Man Machine Interface MENU as the User Interface display screen as Visual Interface and Pushbuttons Keys to move along the MENU instruction entries Display visualizes MENU operations and treatment procedures The operator either selects confirms or modifies treatment modes treatment options operations and parameter settings using the Arrow Keys to move to MENU entries Such active entry is colored turquoise Direction of movement corresponds to the arrow kevs Pushbuttons below the display screen enable instructions like Select Confirm Cancel Apply Start etc TECOTHERM NEO Main MENU always serves as a Starting point for navigation Using
54. sted to select the instruction End Treatment and save data using the arrow keys Options Available Final temperature is currently unchanged Highlight and select the desired option A Endtreatment and save data Back Select Doing so returns to the main menu From there another treatment can be started export stored treatment data or turn off the device Page 31 of 60 Display and export of treatment data To read out and export treatment data and data log files select Entry Reviewland export of treatment data in the Main MENU This submenu offers 3 options e Export new treatment data e Export all treatment data e Select review and export particular treatment data Display and export of treatment data Highlight and select the desired procedure A Export all treatment data Select display and export particular treatment data Back Select Here new treatment data means all those treatments which never have been exported so far including in any case a possibly just only finished treatment Option Select review and export particular treatment data provides acomfortable possibility to graphically represent the complete progress of an earlier treatment identified by date and time at which it has been started If necessary this data can then be copied to a USB stick To find a specific patient record the user must first select the year of the treatment then the month the day and finally the specific treatment itself
55. t of fluid is observed escaping from AN the svstem Possibly alarm Low Fluid Level appears because of leakage Case 1 Large amount of fluid escapes from the TECOTHERM NEO device Management Stop operation by unplugging mains Do not touch device before Caused by Suddenly appearing internal leak in the circulation system Fluid is escaping from inside the unit due to defect or leaking parts or components Splashes and wetness at near or below the device lf possible Replace TECOTHERM NEO device by a replacement unit or a spare unit Put new system into operation following this IU Contact your local service provider Case 2 Fluid escapes from the mattress or hoses Management Stop operation by unplugging mains Caused by Suddenly appearing defect or leak in the mattress along hoses or in coupling connections Wetness in the close vicinity of the patient is possible Try to localize the defect or leak If you find the defect Replace defective component Small leaks may be provisionally sealed as to finish treatment by means of an adhesive tape or appropriate plasters see also section 11 4 NOTE Possibly you have to refill fluid see section 8 5 After replacement or repair re connect TECOTHERM NEO device to the mains It will automatically resume the treatment with the same settings as before unplugging see section 11 5 Contact your local service provider Page 53 of 60 12 Service Preventive Maintenance Software Updat
56. t off Ensure that there is no forced air circulation It may cool down the patient in a re warming phase of the treatment Indications for hazardous substances TECOTHERM NEO does not contain parts or substances originating from derivatives of blood or human animal tissues TECOTHERM NEO does not contain parts made of Latex or its derivatives TECOTHERM NEO Applied Parts do not contain phthalates Thermalizing Fluid is sterile water Skin contact with sterile water is harmless Ambient Conditions AN To ensure proper operation in normal use pav attention to the following conditions e Protection The device should be protected from dampness and wetness e Do not operate device in rooms where flammable mixtures of anesthesia gases with oxygen N20 or air may evolve e To have full cooling power ambient temperature should not exceed 27 C Otherwise the TECOTHERM NEO system may not achieve the lowest possible set temperature e Relative Humidity during treatment should be within a range of 30 80 e Ensure that during treatment operation no installations or devices are operating or are intended to operate next to TECOTHERM NEO which produce ultraviolet radiation intense infrared radiation strong electromagnetic radiation or mechanical shocks vibrations Page 9 of 60 6 TECOTHERM NEO Operating Function 6 1 Fallback mode If BCT measurements occur outside the range of acceptance TECOTHERM NEO will stop operating as a physiologic
57. t vour local service provider Possible causes for this alarm are 1 Leakage in the TECOTHERM NEO device Hydraulic Module 2 Lack of fluid caused by leakage in hoses at couplings or in mattress 3 Slow loss of fluid caused by evaporation through mattress surface Elimination Management lf leakage and or indication of escaped liquid traces of liquid in your immediate inspection were not found refill the system For refilling sterile water follow the procedure as shown in section 8 5 Continue treatment following Main MENU instructions lf alarm persists and symbol is not disappearing a more systematic troubleshooting is required Case 1 Check inspection of the device Inspect the support area below the device device bottom and lower casing parts for traces and indications of escaping liquid If you find a substantial or medium leak Immediately Shut Off the device following the instructions in the Main MENU Unplug mains Contact your local service provider If you find only a small leak contact your local service provider for assistance how to proceed Page 49 of 60 Case 2 Check inspection of mattresses and hoses Inspect the mattress hoses couplings for traces and indications of liquid moisture If you do not find a leakage that could explain the loss of fluid proceed as follows Refill liquid as described in section 8 5 Symbol must vanish Observe the display screen Once alarm disappears start a systematic inspectio
58. tion with a dry cloth Clean and disinfect device bottom side ventilation holes once every 1 2 months and just before treatment as a part of the system preparation Inspect once every three months that air ventilation holes in the device bottom are not covered and are free from dust Remove fluff and dust using a small vacuum cleaner 9 2 Mattresses thermally insulated hoses tubing Used Disposable Mattresses must be discarded as hazardous waste A Attention Do not sterilize Reusable Mattresses Attention When the mattress has been in contact with blood or human secretion during treatment it must be replaced Attention Reusable mattresses should only be used in combination A with thin fabric protective interlaver with plastic coating at bottom side Interlavers are TECOTHERM NEO accessories and can be supplied by the distributors or the manufacturer Such protective interlayer is disposable single use product 9 3 Temperature Probes Reusable Temperature Probes must be disinfected and sterilized after treatment as usual in clinical practice For details read IU of the manufacturer of the probes Caution Keep cable connectors dry to ensure proper probe and AN device operation Do not dip them into liquids Page 36 of 60 10 Storage and Transport 10 1 Storage of the TECOTHERM NEO Device Device The TECOTHERM NEO should be stored in a closed cabinet to protect it against mechanical damage and dust Put it onto a so
59. uitable for use in all Harmonic emissions establishments other than domestic and those directly IEC 61000 3 2 connected to the public low voltage power supply network Voltage fluctuations Complies that supplies buildings used for domestic purposes flicker emissions IEC 61000 3 3 Guidance and manufacturer s declaration electromagnetic immunit The TECOTHERM NEO is intended for use in the electromagnetic environment specified below The customer or the user of the TECOTHERM NEO should assure that it is used in such an environment Immunity test IEC 60601 test Compliance level Electromagnetic environment level guidance Electrostatic 6 kV contact 6 kV contact Floors should be wood concrete or discharge discharge discharge ceramic tile If floors are covered with ESD synthetic material the relative humidity IEC 61000 4 2 8 kV air discharge 8 kV air discharge should be at least 30 Electrical fast 2 kV for power supply 2 kV for power supply transient burst lines line Mains power quality should be that of a IEC 61000 4 4 typical commercial or hospital 1 kV for input output Not applicable le ene lines because not present Surge 1 kV 1kV IEC 61000 4 5 differential mode differential mode Mains power quality should be that of a 2 kV 2 kV typical commercial or hospital common mode common mode environment Voltage dips lt 5 Ur lt 5 Ut Mains power quality should be that of a short interruptions gt
60. v After Switch On of the TECOTHERM NEO the operational readiness of the alarm system is automatically checked through self testing Display screen is showing the Information TECOTHERM NEO Acheck of the internal functions has been performed and did not detect any malfunction Now the alarm functions will be checked Can you see the various Symbols and clearly hear the two alarm sounds ne Yes Confirm YES when you see the various symbols and clearly hear the two alarm sounds If not press NO The display then shows a Pop Up window ERROR It is not allowed to run the device without working alarm functions TECOTHERM NEO will shut off at after 30 seconds TECOTHERM NEO Acheck of the internal functions has been performed and did not detect any malfunction Now the alarm functions will be checked Can you see the various Symbols and clearly hear the two alarm sounds Push key T3 Confirm to immediately shut off device Page 39 of 60 Operator can check alarm functionality at any time during treatment using MENU First push key T3 Options and then use arrow keys to highlight this function Options during operation Thecurrent operation continues to run Highlight and select the desired option A Changes the current settings Immediately start the re warming phase Endtreatment and save data Back Select In critical cases a detailed text display with instructions will appear This text field will give information co
61. y mass may severely influence re warming The larger the mass the slower the re warming Portable and mobile RF communication equipment can affect medical electrical equipment Observe the recommended separation distances in the EMC tables e The TECOTHERM NEO device should be subject to regular maintenance and service e Refill sterile water regularly every 2 months see section 8 5 e Note Circulation may stop fluid flow stops AN In such cases mattresses mav cool patient down slowlv During treatment re warming phase patient may suffer from extraction of body heat back into the mattress This must be addressed without delay e The operator or the user should not apply other cleaning disinfecting and decontamination procedures than those recommended by the manufacturer If in doubt contact your local representative Precaution Notes for Placement A Location e The TECOTHERM NEO device should not be used adjacent to or stacked with other equipment e The unit must be placed in such a way that it could be easily disconnected from mains power Removing the mains plug must always be possible e The unit must be placed horizontally onto a support e The system is fan cooled Sufficient space must be allocated so that a free flow of air from all sides can reach the bottom of the device when it is in operation e Device should be located so that there is a distance of at least 15cm between rear face and a wall or another limiting
62. y secured If a skin probe is used plug it correctly to its socket S Place it correctly at the abdomen or at the forehead and secure it Page 28 of 60 Putting TECOTHERM NEO into operation After completing the above mentioned preparations the system is ready to operate Press Pushbutton 1 The lit key changes to intensive Green Note TECOTHERM NEO is running a self test to check internal functions followed by a test of the alarm functions Display screen must be illuminated LED indicators 4 and 5 must flash Device Is emanating an intensive BEEP followed by a blue flash of the 15 button and intensive double BEEP The operator is asked to confirm YES by pressing key T3 that the various symbols can be seen and two alarm sounds clearly heard Should anything be wrong answer NO pressing key T1 or simply do nothing Device will shut down TECOTHERM NEO Acheck of the internal functions has been performed and did not detect any malfunction Now the alarm functions will be checked Can you see the various Symbols and clearly hear the two alarm sounds i l After confirmation YES the TECOTHERM NEO Main MENU is displayed Yes TECOTHERM NEO Main Menu Highlight and Select Function Required Servocontrol mode constant rectal temperature Constant Mattress Temperature Mode Alarmcheck Export treatment data Service Language Power Off Ser Nr 2010 08 01 y Rev 023 01 32 Select Using Main MENU and pushing

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