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IfU TECOTHERM NEO TN300 EN - 01.doc

Page 69 of 76

Ref No. TN300 EN-01

Power supply failure / No supply from the mains.

Operation is interrupted and stopped caused by mains power failure

NOTE

Do

not push

key (1) to start a new operation.

TECOTHERM NEO will continue the previous treatment

mode automatically when mains supply reappears.

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

The operator is asked to continue the interrupted treatment or not, see MENU picture
below. Confirm YES to continue or pushing key T3, NO to start a new treatment

TECOTHERM NEO

Confirm to continue with "Yes"

No

Yes

Power failure during treatment - do you wish to continue with

or

Start a new treatment with "No".

previous treatment?

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Содержание Tecotherm Neo

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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