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IfU TECOTHERM NEO TN300 EN - 01.doc

TEC COM GmbH

TECOTHERM NEO

MEDICAL EQUIPMENT for HYPOTHERMIA
of NEONATE and INFANTS

Instructions for Use

Summary of Contents for Tecotherm Neo

Page 1: ...IfU TECOTHERM NEO TN300 EN 01 doc TEC COM GmbH TECOTHERM NEO MEDICAL EQUIPMENT for HYPOTHERMIA of NEONATE and INFANTS Instructions for Use...

Page 2: ...O Hypothermia System Putting into operationTECOTHERM 40 8 1 Initial Set up Initial Operation 40 8 2 Initial Operation by the customer Pre operation Check up 40 8 3 Initial Operation by the customer 40...

Page 3: ...on hole structure device bottom 72 13 3 Substitution of TECOmed fluid 72 13 4 Substitution of TECOmed fluid in mattresses and cool wraps 73 13 5 Software Update 73 13 6 Check calibration of temperatur...

Page 4: ...e using MENU assistance TECOTHERM NEO of TEC COM has been equipped with two micro computers and with numerous monitoring and alarm features which guarantee a high standard of treatment and operation s...

Page 5: ...of mattress or cool wrap with patient s skin Avoid direct contact of mattress or cool wrap with fresh or non closed wounds infectious areas areas with ulceration and abcesses rash and burns 2 3 Requi...

Page 6: ...C COM or authorized representives will instruct and introduce the operation personnel prior putting the equipment into operation Information technical support additional manuals may be requested from...

Page 7: ...controlled way by a circulating fluid This physiologically safe water based fluid is cooled or warmed in the device and flows through the mattress or wrap continuously supplying the patient with ther...

Page 8: ...emperature Mode 3 Constant Mattress Temperature Mode The Operator selects the treatment mode 1 2 or 3 and treatment parameters for inducing hypothermia normothermia or hyperthermia following the MENU...

Page 9: ...ormation Attention Caution Warning Electrical Hazard Applied Part Type BF Rectal Temperature Sensor socket R Skin Temperature Sensor socket S Key Turn On System failure SF Temperature Alarm Alarm No o...

Page 10: ...manufacturer Applying different probes may lead to incorrect and wrong temperature data This is likely to put patients at significant risk Ensure that Rectal and Skin Temperature Probes are correctly...

Page 11: ...esentative Precaution Notes for placement Location The unit must be placed horizontally onto a level support The system is fan cooled Sufficient space must be allocated so that a free flow of air from...

Page 12: ...ation Using an incubator When using an incubator to perform hypothermia treatment Pay attention that there is enough space to properly place mattress or cool wrap Otherwise kinking of hose set and or...

Page 13: ...ECOmed fluid is harmless Note After use close TECOmed containers tightly Ambient Conditions To ensure a proper operation in normal use pay attention to the following conditions Protection The device s...

Page 14: ...s Consider possible mechanical means for positioning supporting or erecting the patient during treatment They may block or reduce fluid circulation We recommend that operator should independently moni...

Page 15: ...ermally shielded to connect application parts to the device Fill up set includes necessary components for filling re filling TECOmed 5 litre TECOmed fluid canned in PE or PP container Thin protective...

Page 16: ...eratures During circulation the micro computer of the Control Board is permanently comparing analysing the measured and set rectal temperatures The larger the deviation between the two temepratures th...

Page 17: ...n see section 8 Note This mode is limited to temperatures and profiles stated in the TOBY Study protocol see reference for inducing hypothermia in neonate suffering from Hypoxic Ischemic Encephalopath...

Page 18: ...ershooting undershooting Treatment section III Cooling Phase Reaching the set temperature 33 5 C the system continues treatment to hold BCT of the patient constant Treatment time is preselected by the...

Page 19: ...an be read out transferred to an USB stick see section 7 3 for the USB port NOTE All parameters can be changed from set position at ANY TIME should the need arise Changes will be stored on the TECOTHE...

Page 20: ...e is displayed on the screen in the small parameter boxes in the upper part of the display feature DIAGRAM and as temperature profile in the display feature DIAGRAM see section 7 3 of this IfU Change...

Page 21: ...be placed onto the mattress cool wrap Rectal probe should be inserted and secured To start treatment follow the instructions of the MENU The TECOTHERM NEO device pumps TECOmed through mattresses wrap...

Page 22: ...re shown in the display feature DIAGRAM Observing the temperature profiles the operator is able to check the temperature constancy over the treatment time Rectal temperature is held within a temperatu...

Page 23: ...requires installation of another independent accurate calibrated temperature probe rectal probe or bladder catheter sensor with a separate display showing the rectal temperature Note Operator may cont...

Page 24: ...arly and visible from distance Controlled mattress temperature range 12 C 39 C Necessary TECOTHERM NEO system equipment to run treatment is TECOTHERM NEO device Mattress for total body cooling filled...

Page 25: ...ue Keep in mind that changes in mattress temperature as a rule are seen in the BCT only after hour In the Cooling Phase to hold BCT at the Target Temperature Value the operator should observe the BCT...

Page 26: ...re constancy 0 3 C Temperature accuracy 0 1 C Body Core Temperature control range 1 32 C 33 5 C 38 C 2 30 C 38 C Hydraulic circulation system Fluid TECOmed Reservoir capacity approx 250 ml Fluid flow...

Page 27: ...ttons are clearly arranged at the front panel Mains socket and sockets for USB are positioned at the rear side Figure TECOTHERM NEO Hypothermia Device More details see Section 7 3 Central Cooling Warm...

Page 28: ...nd with a Control Board to control its operation features Both boards are based on their separate powerful micro computers which are in permanent communication master OP slave CB TECOTHERM NEO has thr...

Page 29: ...Central Cooling Warming 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 ab...

Page 30: ...D Indicator System Failure T 1 Pushbutton for MENU operations meaning indicated on display T 2 Pushbutton for MENU operations meaning indicated on display T 3 Pushbutton for MENU operations meaning in...

Page 31: ...IfU TECOTHERM NEO TN300 EN 01 doc Page 31 of 76 Ref No TN300 EN 01 Figure TECOTHERM NEO Rear side 8 Mains Socket 9 USB socket 10 Network socket not operating Further details see Section 7 9...

Page 32: ...tails Set Point 33 5 33 4 Treatment mode 3 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...

Page 33: ...th REDEL connector reusable autoclavable NOTE Rectal probe and Skin probe connectors have their individually mating sockets R and S No confusion possible Body core temperature BCT is measured with the...

Page 34: ...ors are plugged to the device ports 6 see section 7 3 and 8 3 Mattresses and other applied parts are connected to the female connectors of the hoses All connectors are self sealing quick disconnect co...

Page 35: ...C couplings plugged to ports 7 in the device front panel see section 7 3 Container volume of TECOmed liquid is 500 ml marked every 100 ml Figure Fill up set 7 7 TECOmed Thermalizing Fluid TECOTHERM NE...

Page 36: ...r positioning T NEO cool wraps we recommend small felt fixation tapes Tapes are fed through eyelets at right and left sides of the wrap then forming a loop Both tape ends are knoted The user may selec...

Page 37: ...gure Cool Wrap T NEO PAD with its typical pattern structure to ensure proper flow and fluid distribution 420 mm 620 mm 365 mm Protecting Foil layer Use thin disposable interlayer which must at least f...

Page 38: ...low display screen enable performing instructions like Select Confirm Cancel Apply Start etc TECOTHERM NEO Main MENU always serves as a Starting point for navigation Using Main MENU the operator selec...

Page 39: ...l NOTE Arectal probe is required to be inserted prior to treatment Servo controlled complete treatment mode Confirm Cancel For reference an additional skin temperature probe is strongly Please confirm...

Page 40: ...check the conditions section 6 to ensure safe and proper operation For a reliable and safe operation use only original components applied parts and spare parts supplied or recommended by the manufact...

Page 41: ...terparts of the mattress Then plug to the ports 6 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 procedure Figu...

Page 42: ...and properly secured If a skin probe is used plug it correctly to its socket S Place it correctly abdominal or at the forehead and secure it Putting TECOTHERM NEO into operation After passing the abov...

Page 43: ...tment data Service Power Off Select Language Using Main MENU and pushing arrow keys the operator selects entry Language and is led to a list of available languages English Deutsch Espanol After select...

Page 44: ...RT for starting Treatment Section I Thermal preparation of the mattress Servo controlled complete treatment mode Mattress temperature at start of treatment Select Apply standard settings or highlight...

Page 45: ...e for 00 43 hours 23 03 2010 08 55 42 Options Mattress Temperature Rectal Temperature Skin Temperature 34 2 28 2 15 20 25 30 35 1 2 3 4 5 6 7 8 9 hour 15 20 25 30 35 Treatment Mode 3 Constant Mattress...

Page 46: ...LARGE SIZE NUMBER Treatment is running NOTE We recommend that during treatment operator should from time to time monitor patient temperatures This is especially important during transition from coolin...

Page 47: ...Data in the Main MENU To perform export plug an USB stick into the USB port 9 at the device rear side Then follow MENU instructions push Select The operator gets an information on the screen whether d...

Page 48: ...structions looking for entry Power Off Push arrow key to move to entry POWER OFF TECOTHERM NEO Main Menu Ser Nr 2010 08 01 Rev 023 01 32 Highlight and Select Function Required Servo controlled complet...

Page 49: ...port QDC counterparts 7 at the device front face Turn bottle until cap is directed downwards Lift fill up bottle in a position m higher than the TECOTHERM device Keep this position Start of filling u...

Page 50: ...dual small bubbles in the mattress do not disturb circulation flow Then disconnect fill up bottle Unscrew bottle cap 1 2 revolution for pressure compensation a few seconds Then close bottle cap tightl...

Page 51: ...lly spread onto a level support Ensure that mattress and ports 6 are on the same level approximately Use only mattresses specified or recommended by TEC COM as the manufacturer of the TECOTHERM NEO sy...

Page 52: ...ensuring good thermal insulation during hypothermia operation Place protective interlayer onto the cool wrap mattress Place neonate onto A B C region Place head onto A Feets schould be located at part...

Page 53: ...ths that air ventilation holes in the device bottom side are not flue covered and free from dust Remove flues and dust using a small vacuum cleaner 9 2 Mattresses thermally insulated hoses tubing Matt...

Page 54: ...t mechanical damage and dust Put it onto a solid board horizontally standing on feet Store in a dry ambient Storage temperatures 5 C 40 C with TECOmed fluid Storage temperatures 5 C 60 C without TECOm...

Page 55: ...years The mattress material is polyurethane plastic It is slightly permeable for water and ethanol Fluid evaporates from the mattress surface if storage box is not closed Fluid volume is reduced 10 3...

Page 56: ...ther alarms of dB A 57 approximately Interruption of power supply does not influence or alter the alarm settings They are automatically reset when power is on and alarm cause is persisting Assignment...

Page 57: ...rking alarm functions TECOTHERM NEO will shut off at after 30 seconds Push key T1 Confirm to immediately shut off the device TECOTHERM NEO Acheck of the internal functions has been performed and did n...

Page 58: ...AM accompanied by optical and acoustical alarms 2 System alarm SF LED 5 in the lower part of the front panel The LED pictogram is activated accompanied by optical and acoustical alarms This feature is...

Page 59: ...ive pump Temperature exceeding limits Internal communication problems between Operational System and Control system Elimination Management Step1 did not solve the problem Shut off device by unplugging...

Page 60: ...is lit System continues operating with the set parameters unless operator is silencing audible alarm pushing key T5 AUDIO paused The Control Board then 10 seconds later is switching off the device The...

Page 61: ...ted from the device Rectal Temperature probe is detached from patient System operation temperature deviates more than 0 5 C from set rectal emperature Mattress temperature incorrectly measured Fan coo...

Page 62: ...se is eliminated rectal temperature reappears in the information box Observe display until measured rectal temperature approaches the set rectal temperature If no success probe may have a sensor break...

Page 63: ...rd cannot regulate to hold rectal temperature constant Measure Push key T1 Options to enter Main MENU and select entry Power Off using arrow keys Device is shut down Do not switch on the device again...

Page 64: ...42 Options Mattress Temperature Rectal Temperature Skin Temperature 34 2 28 2 15 20 25 30 35 1 2 3 4 5 6 7 8 9 hour 15 20 25 30 35 The mattress gets for more than 10 seconds too little fluid to maint...

Page 65: ...device front face Turn bottle until cap is directed downwards Lift fill up bottle in a position m higher than the TECOTHERM device Keep this position Observe whether symbol No Flow disappears Note 5 s...

Page 66: ...below or near the device immediately shut off the device Proceed as in other alarm cases Follow the instructions in the Main MENU Contact your local service Elimination Management If leakage or and in...

Page 67: ...atment Close the small leak by means of an adhesive tape or appropriate plasters non permeable After finishing the treatment you have to replace the defective part or repair the mattress using the rep...

Page 68: ...d is tightly plugged to the mains socket and to the device rear socket If unplugged plug it tightly Fuses Check fuses Fuses are located in a small compartment of the device socket Unplug mains cable a...

Page 69: ...pears TECOTHERM NEO is designed to continue operation in the previous treatment mode when mains voltage reappears Treatment configuration is restored within an interruption period of max 60 minutes Th...

Page 70: ...t near or below the device Management Elimination STOP OPERATION POWER OFF UNPLUG MAINS Replace TECOTHERM NEO device by a replacement unit or a spare unit Put new system into operation Start operation...

Page 71: ...ly successful System will reboot If necessary customer should turn to the TECOTHERM NEO manufacturer TEC COM GmbH or Authorized Service Representative for assistance and support Service Update Change...

Page 72: ...uthorized service provider is necessary The inspection has to be done in compliance with current local legal rules and regulations The manufacturer recommends system check and calibration at least eve...

Page 73: ...on 8 5 of this IfU Then repeat emptying procedure as described above Final step Refill TECOTHERM NEO as described in section 8 5 of this IfU Substitution of TECOmed fluid is finished TECOTHERM NEO is...

Page 74: ...omponents parts and spare parts supplied or licensed by the manufacturer Use only such components parts and accessories for hypothermia treatment with a TECOTHERM NEO system Warning Substitution of or...

Page 75: ...ative Humidity Storage Transport Filled with fluid No fluid Relative Humidity System safety Protection class Standards Certificate Cooling Warming 375 x 190 215 x 310 mm W x D x H approx 7 2 kg Thermo...

Page 76: ...ments of Medical Device Directive 93 42 EEC are fulfilled acc ann III EC type examination ann I ann V Declaration of Conformity Each device is produced in full compliance with the technical documentat...

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