tecotherm_neo_instructions_for_use__revision_april_.pdf
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TEC COM GmbH
TECOTHERM NEO
MEDICAL EQUIPMENT for HYPOTHERMIA
of NEONATE and INFANTS
Instructions for Use
Revision April 2014
Applicable for software version 062/02.16 and higher
IfU TECOTHERM NEO TN300 EN-15.docx
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Contents and abbreviations
page
1.
1.1
1.2
1.3
2.
3.
4.
5.
6.
6.1
6.2
6.2.1
6.2.2
7.
7.1
7.1.1
7.1.2
7.1.3
7.2
7.3
7.4
7.5
7.6
7.7.
7.8
7.9
7.10
8.
8.1
8.2
8.3
8.4
8.5
8.6
8.7
9.
9.1
9.2
9.3
10.
10.1
10.2
10.3
10.4
Preface ............................................................................................
Intended Use ...................................................................................
Contraindications for Use ................................................................
Operators Profile .............................................................................
Informations for Customers, Service & Technical support ..............
Short Description of the Equipment ................................................
Symbols, Indications .......................................................................
Warnings, precaution guidelines .....................................................
TECOTHERM NEO operating functions .........................................
The physiologic closed-loop circuit (PCLC) .....................................
Fallback mode .................................................................................
Plausibility limitations in rectal temperature measurement ..............
Operations during fallback mode ....................................................
TECOTHERM NEO Hypothermia System ....................................
TECOTHERM NEO operating modes .............................................
Complete Treatment Mode (Servo controlled), Treatment profiles .
Servo Control Mode (constant rectal temperature) .........................
Constant Mattress Temperature Mode ...........................................
TECOTHERM NEO Hypothermia System Informations ..................
Indicators and Operation Key elements, Display screen .................
External Temperature Probes .........................................................
Hoses, Hydraulic lines .....................................................................
Fill- up set for Filling / Refilling TECOmed thermalizing fluid ..........
TECOmed thermalizing fluid ...........................................................
Mattresses, Cool Wraps, parts and protective layers ......................
MENU and the User Interface .........................................................
Display and export of treatment data ..............................................
TECOTHERM NEO Hypothermia System Putting into operation ....
Initial Set up / Initial Operation ........................................................
Pre- operation Check up .................................................................
Initial Operation by the customer ....................................................
Stop operation / Turn off device ......................................................
TECOTHERM NEO System: Filling / Refilling Procedures ...........
Draining a used mattress ................................................................
Application of mattresses to patients ..............................................
Hygienic Requirements ...................................................................
Cleaning and Disinfecting TECOTHERM NEO ...............................
Mattresses, thermally insulated hoses, tubing ................................
Temperature Probes .......................................................................
Storage and Transport ....................................................................
Storage of the TECOTHERM NEO device ......................................
Storage of Mattresses .....................................................................
Storage of TECOmed .....................................................................
Transport .........................................................................................
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Ref No. TN300 EN-15
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11.
11.1
11.2
11.3
11.4
11.5
11.6
12.
13.
13.1
13.2
13.3
13.4
13.5
13.6
14.
15.
16.
17.
Alarm system, malfunctions, incident management ........................
System Alarm, System failure .........................................................
Temperature Alarm .........................................................................
Flow rate alarm ...............................................................................
Alarm Fluid level low .....................................................................
Alarm No Mains Power .................................................................
Fluid escapes from the TECOTHERM NEO System ......................
Training & Qualification of personnel ..............................................
Service, preventive maintenance, Software Update .......................
Service & Maintenance ...................................................................
Cleaning the ventilation hole structure (device bottom) ..................
Substitution of TECOmed fluid in the device ...................................
Substitution of TECOmed fluid in mattresses and cool wraps .........
Check / calibration of temperature probes ......................................
Software Update .............................................................................
Technical Data, TECOTHERM NEO Specification .........................
Declaration of Conformity ................................................................
Disposal ..........................................................................................
EMC guidance for TECOTHERM NEO ...........................................
65
68
70
73
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81
81
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82
82
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85
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Abbreviations
IfU
BCT
Instruction for Use
Body Core Temperature, as measured via the Rectum
using appropriate rectal temperature probes, see 7.4
SF
System Failure
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1.
Preface
1.1
Intended Use
This Instructions for Use (IfU) presents a detailed introduction into the
operation modes of TECOTHERM NEO from TEC COM GmbH.
The Hypothermia System TECOTHERM NEO is designed for controlled
comfortable cold & heat treatment procedures. By means of mattresses or
cool wraps cold and heat is applied to the total body, body parts or areas of
neonate depending on the therapy objective.
One main application is induced hypothermia treatment of neonate affected
with Hypoxic Ischemic Encephalopathy.
The IfU contains a Technical Desription and technical data.
TECOTHERM NEO of TEC COM exhibits SERVO CONTROL operation as
a modern excellence feature 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 safety.
We highly recommend that the operator is familiar with the operation
modes and capabilities of the TECOTHERM NEO. Prior to putting into
operation carefully read these IfU!
This IfU is associated with a software version 062/02.16 or higher. The
installed version number is displayed at the lower left part of operator’s
MENU display screen after switching on the device.
Note: The Manufacturer carries responsibility for basic safety, reliability
and capability of the TECOTHERM NEO system only when
local electrical installation fully meets the requirements of the IfU.
initial operation is performed according prescribed Instruction
procedure by authorized personnel.
TECOTHERM NEO is operated according to the instructions and
statements of said IfU.
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1.2
Contraindications for Use
No general contraindications are known. For possible adverse effects study
the relevant treatment and therapy protocols.
Avoid direct contact 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.
1.3
Operators Profile
TECOTHERM NEO is intended for use by healthcare professionals only.
Operating a TECOTHERM NEO requires
Education as Healthcare Professional
Experience in using life support and life sustaining equipment
Experience in using medical electrical equipment
Personnel must be trained in the use of the TECOTHERM NEO
before operating the device.
We strongly recommend operators to get familiar with the working
principles of the TECOTHERM NEO, to develop an understanding
of mechanism and procedure of a hypothermia treatment, and to
carefully read this Instruction for Use.
Note
Operator is requested to carefully check all accepted default or
personally set parameters for correctness and adequacy
before starting the hypothermia treatment.
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2.
Informations for Customers
Service & Technical support
For Technical Support in German please contact:
TEC COM GmbH
Phone
Fax
E mail
+49 - 345 - 120 52 04
+49 - 345 – 120 52 11
info@teccom-halle.de
For Technical Support in English please contact:
Inspiration Healthcare Ltd
Phone
+44 - 1455 840555
Fax
+44 - 1455 841464
E mail
info@inspiration-healthcare.co.uk
The manufacturer TEC COM or authorized representives will instruct and
introduce the operation personnel prior putting the equipment into
operation
Additional information, technical support, additional manuals may be
requested from the manufacturer and any authorized distribution partner.
Manufacturer
TEC COM GmbH
Gesellschaft für Technik, Technologie und Vermarktung
Am Krümmling 1
D-06184 Kabelsketal
Germany
Type label
TECOTHERM NEO
Serial Number 2014 / 15 / 01
100-130V / 200-240V
50-60Hz
max. 350W
Class I / Schutzklasse I IP20 Made in Germany
Fuses / Sicherungen: 5x20mm 250VAC
100-130V: S4AH / T4AH 200-240V: S2,5AH / T2,5AH
Manufacturer / Hersteller: TEC COM GmbH
Am Krümmling 1
D-06184 Kabelsketal
0494
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3.
Short Description of the Equipment
The Hypothermia System TECOTHERM NEO is designed for controlled cold & heat
treatment procedures and application of specific cold and heat doses to neonate and
babies. The system applies cold and heat to total body, body parts and areas
depending on therapy target by means of mattresses and / or cool wraps NEO PAD.
One main application is hypothermia treatment of neonate affected with Hypoxic
Ischemic Encephalopathy.
Another application designed for controlled hypothermia treatment is Total Body
Treatment of Children up to body mass of 50 kg.
TECOTHERM NEO consists of a unique cold & heat generating device, applied parts
like mattresses and wrap, interconnecting hoses (tubing set), accessories. Applied parts
are connected to the device via hoses by self- sealing quick- disconnect couplings.
The patient is provided with cold and heat according therapy target in a fully controlled
way by a circulating fluid. This physiologic safe water- based fluid is cooled or warmed
in the device and flows through the mattress or wrap continuously supplying the patient
with therapeutically prescribed doses.
Patient temperatures are measured with approved calibrated probes connected to the
TECOTHERM NEO device. Temperature data is permanently communicated to the
device Operational System.
Circulation of thermalizing fluid to provide cold and heat, accurately reaching set points
and operating at set point temperatures accurately with max. deviation of +/-0,3°C,
monitoring the treatment, and alarming when exceeding or falling below temperature
limits are performances of TECOTHERM NEO.
TECOTHERM NEO is a system with built-in physiologic closed loop circuit PCLC.
TECOTHERM NEO is electronically divided into an Operational System and a
Controlling System. Both sub systems are micro computer (µC) based. Both µC
communicate permanently to ensure safe and proper operation according to therapy
needs.
A comfortable user MENU will guide the operator to the treatment modes, advise how to
proceed the treatment and how to manage treatment details.
Menu language may be preselected using Sub – Menu “Language”: English, Deutsch,
Espanol …. .
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TECOTHERM NEO offers three separate treatment modes to induce hypothermia and
to re- warm the patients. TECOTHERM NEO uses 2 independent temperature probes:
rectal probe for measuring Body Core Temperature (BCT), mandatory required
for SERVO mode.
skin probe for measuring skin abdominal or forehead temperature etc, optional.
The three treatment modes are
I
SERVO CONTROL Programmable Complete Treatment Mode
II SERVO CONTROL Constant Rectal Temperature Mode
III Constant Mattress Temperature Mode
The Operator selects the treatment mode I, II or III and treatment parameters for
inducing hypothermia, normothermia or hyperthermia following the MENU instructions.
Attention:
Temperature probes must be properly placed before treatment procedure
can start.
Attention
Treatment and selection of treatment procedure is fully within the
responsibility of the therapist, physician or trained qualified medical personnel.
Attention
For neonate and other patient hypersensitivity or restricted compatibility to
hypothermia and / or hyperthermia is in general not known. Neonate receiving such
treatment must be under careful observation.
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4.
Symbols, Indications
Important Information
Attention, Caution, Warning
Electrical Hazard !
Do not touch contacts!
Applied Part Type BF
Consult Instruction for Use
Rectal Temperature Sensor socket
R
Skin Temperature Sensor socket
S
Key “Turn On”
System failure
SF
Temperature Alarm
Alarm No or restricted Flow
Alarm Low fluid level
Symbol AUDIO paused
No Mains Power (separate LED indicator)
Internal System Failure (separate LED indicator)
IfU TECOTHERM NEO TN300 EN-15.docx
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5.
Warnings, Precaution guidelines
Warnings
Modification of the TECOTHERM NEO not authorized by the manufacturer
is not allowed.
Do not open the device! Risk of electrical shock.
Opening the device is restricted to service
and other authorized personnel.
Do not remove cover part. Risk of electrical shock when touching inner parts and
components.
The TECOTHERM NEO device must be plugged to the mains only to 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.
Caution During operation and treatment: The operator must
not simultaneously touch the patient and metallic device parts
(plug / connector sockets, grounded connected parts at the device rear,
contacts of fuse compartment).
Both temperature probe sockets on the front of 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 precautionary procedure is required:
Before plugging, touch the fan protective grid at the rear with your other hand.
It is recommended that all staff involved in using TECOTHERM NEO receive an
explanation of the ESD warning symbol and training in ESD precautionary
procedures.
That training should include, in addition to the precautionary procedure
prescribed above, general information on the origin, the possible impact
and the prevention of electrostatic charging.
Repair and maintenance are restricted to authorised personnel only!
For a reliable and safe operation use only original components, applied parts and
spare parts supplied or recommended by the manufacturer.
Substitution of original parts or components of the TECOTHERM NEO system by
parts or components which are not licensed by the manufacturer is likely to put
the system and the patient at risk!
Only TECOmed (or approved substitute ) should be used as circulating fluid.
Otherwise it would be likely to put the system and the patient at risk!
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Use only temperature probes in accordance with IfU 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!
Ensure that probes are properly connected to the TECOTHERM NEO socket
marked "R" (Rectal for Body Core Temperature) and “S” (Skin for Surface
Temperature).
Ensure that Rectal and Skin Temperature Probes are
correctly placed in / on the patient and that probes are
properly secured.
Do not use TECOTHERM NEO with or in presence of flammable agents.
Safety, Reliability
Caution
For a reliable and safe operation of the TECOTHERM NEO use only
original components, parts and spare parts and accessories supplied or licensed by the
manufacturer.
Use only such components, parts and accessories for hypothermia treatment with a
TECOTHERM NEO system!
Warning
Substitution of original parts or components of the TECOTHERM NEO
system by parts or components which are not licensed by the
manufacturer is likely to put the system and the patient at risk!
Precautions
Consider within Intended Use
Note: Therapeutic Induced Total Body Hypothermia 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 body mass may severely influence re- warming. The larger the mass the
slower the re- warming.
Futher notes
When TECOTHERM NEO is run in the Constant Mattress Temperature Mode to lower
body core temperature an independent temperature measurement is required to monitor
hypothermia.
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Note that in this mode applied treatment temperature and duration do not allow a
realistic estimation of the actual degree of lowering of patient’s BCT.
Medical electrical equipment needs special precautions regarding Electromagnetic
Compatibility and needs to be installed and put into service according to the
Electromagnetic Compatibility information provided below in 17. EMC guidance.
Portable and mobile RF communication equipment can affect medical electrical
equipment. Observe the recommended separation distances listed below
in 17. EMC guidance.
The TECOTHERM NEO device should be subject to regular maintenance and
service, see section 13.
Refill TECOmed fluid regularly every 3 months, see section 8.5.
Note Circulation may stop, fluid flow stops.
In such cases mattresses may cool neonate or patient slowly down. Especially during
treatment re-warming phase neonate may suffer from extraction of body heat back
into the mattress. Change such condition soon!
Replace TECOmed fluid regularly every 3 months, see section 8.5. / 13.3.
Only TECOmed (or approved substitute ) should be used.
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
Location
The TECOTHERM NEO device should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the TECOTHERM NEO should
be observed to verify normal operation in the configuration in which it will be used.
The unit must be placed in such a way that it could be easily disconnected from
mains power. Removing the mains plug must be always possible.
The unit must be placed horizontally onto a plane support
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.
Device should be located so that there is a distance of at least 15cm between rear
side and a wall or another limiting surface to ensure free outflow of the cooling air.
Do not place the device into small cabinet compartment or onto small scale boards.
Do not cover the device!
The unit should be placed avoiding air to be blown towards the patient.
The unit should be placed so that optical blink alarms are clearly seen and acoustic
alarms are clearly audible.
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Do not place mattresses and hoses onto hot or warm supports during operation
Do not place the device during operation near intensive heat sources.
Attention
Ensure and leave enough space around the TECOTHERM NEO not to
obstruct passage of acting personnel. Ensure that hoses, cable cord, temperature
probes etc. do not form obstacles.
Ensure that placement of TECOTHERM NEO is not forming trapping zones for hands
and fingers to avoid contusions and other injuries.
Check type of mattress and interlayer. Use thin disposable interlayer which must at
least fully cover the mattress with some border. Such interlayer must be coated at
lower side with plastic coating to prevent penetration of blood, liquids or liquid media
onto the upper surface of the mattress and to protect the patient.
Note: Place mattress/ cool wrap onto a 10 - 20 mm thick foam material that has
good thermal insulation during operation.
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 tubing near mattress and mattress folding may
cause restricted fluid flow, bad circulation or even flow blocking
Place the hoses set in a way that the hoses are in a straight line. Fasten the hoses in
such a way to avoid kinking of the tubing near the mattress
Note:
Place mattress onto a 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 shut off! Ensure that there is no forced
air circulation. It may cool down the neonate in a re- warming phase of the treatment.
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Indications for hazardous substances
TECOTHERM NEO does not contain parts or substances stemming 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 parts made of PVC with DEHP
softener / plasticizer
Thermalizing Fluid TECOmed is made of 70 % water, 30% pure Ethyl alcohol. Very
small quantity < 0,3 % denaturing agent Methyl- Ethyl- Ketone MEK is added. Details
see Safety Data Sheet.
Caution
Do not swallow or ingest fluid.
Skin contact with TECOmed 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 should be protected from dampness and wetness
(e.g. splash water.)
Do not operate device in rooms where flammable mixtures of anaesthesia gases
with oxygen, laughing gas N2O or air may evolve.
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
if using a large mattress.
Relative Humidity during treatment within a range of 30 % - 80 %
Ensure that during treatment / operation no installations, systems, devices and the
like are operating or are intended to operate next to TECOTHERM NEO and
producing
ultraviolet radiation
intense infrared radiation
strong electromagnetic radiation
mechanical shocks, vibrations.
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6.
TECOTHERM NEO operating functions
Operators should familiarise themselves with the operating instructions. It is of crucial
importance that they are fully familiar with the actions to be taken in the case of alarms
and initial operating errors occurring during use.
Operators should furthermore develop an understanding of the TECOTHERM NEO as a
system, comprising of a physiologic closed-loop circuit (PCLC).
6.1
The physiologic closed-loop circuit (PCLC)
In accordance with specified applications (see 1.1) TECOTHERM NEO is used to
regulate rectal measured body core temperature of patients, which is a physiologic
variable, in a specific way or to maintain it at a constant level. Following an as rapid as
possible cooling down to 33.5°C this temperature is subsequently to be maintained over
a 72 hour period, followed by a gradual steady re-warming up to 37°C within a period of
7 hours or longer.
This is achieved by placing the patient into effective thermal contact with a coolant fluid
perfusion mattress (see 8.7). The temperature of the fluid determines the changes
which will take place in the patient’s core body temperature: if it is lower than that of the
patient, the patient’s temperature will fall – if it is higher the patient’s temperature will
rise. The greater the difference in temperature between patient and the fluid the faster
the change in the patient’s core body temperature, whereby a change of 0.5°C / hour
should already be considered being rather “rapid”. The mattress temperature (i.e. the
average temperature of the fluid) must obviously be maintained within certain limits in
order to prevent possible damage to tissue (frostbite, burns). These limits are set at
12°C and 39°C respectively, whereby temperatures around 12°C are needed only
during the initial treatment phase to allow for an as rapid as possible cooling down
process; subsequently these temperature levels will no longer be required.
In order to achieve the intended progression in the patient’s core body temperature the
mattress must be kept at the correct temperature level, at all times. The right
temperature will depend on a number of factors: what is the current stage of treatment;
what are the (changing) ambient conditions, environmental factors; how effective is the
thermal contact between mattress and the patient; how intensive or reduced is the
patient’s own level of thermal output. First of all, sufficient information concerning the
patient’s current core body temperature must be available in order to determine the
correct mattress temperature required. However, the impact of external factors is often
rather complex and difficult to assess, so that manual setting of the mattress
temperature by the operator will often result in more or less wide fluctuations of the core
temperature around the target level, especially as the actual results of a temperature
adjustment do rarely become apparent within less than a half-hour period. This also
does lead to increased nursing requirements, since repeated adjustments in
temperature will become necessary.
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The operator is spared these complex considerations and corresponding decisionmaking process by the automatic temperature control system performing these tasks in
the two automatic operating modes. The operator now merely needs to schedule the
overall intended progression of change in the patient’s core body temperature in
advance, using a limited number of parameters, which can be intuitively understood.
The temperature control system using the rectal temperature measurements
subsequently calculates the exact mattress temperature required, on a continuous
basis, in order to stay within the set schedule. The TECOTHERM NEO temperature
control module ensures that the mattress delivers the temperature required based on
these calculations, as fast as possible.
Like any other temperature control system TECOTHERM NEO comprises a closed-loop
control circuit. Any deviation from target settings is counteracted immediately.
Assuming that the rectal temperature measurement is 0.1° higher than it should be, at
any given point in time, the control system would lower the mattress temperature by 1° if
the internally programmed amplification factor had a value of 10. With a certain delay
this lowering of mattress temperature will result in a corresponding decrease in rectal
temperature and the subsequent gradual convergence back towards the target value.
As a result the decrease in mattress temperature will in turn be reduced. Thus the cycle
is closed and since the regulated rectal temperature is a physiologic variable of
measurement this represents a physiologic closed-loop circuit (PCLC).
During the initial stages of treatment, i.e. rapid cooling down of the patient, an inevitable
overshoot will occur – actual values will in fact fall somewhat short of the target value
of 33.5°C. Standard parameters have been chosen to reduce such overshoot to below
0.5°. A stable status is subsequently reached within a settling time of approx. 1 hour;
there are no remaining deviations from set parameters. During this constant phase,
which usually lasts about 72 hours, potential fluctuations will be less than 0.3°.
Following commencement of the re-warming phase there will initially be a rise in
mattress temperature. Only after a response period of approx. 30 minutes will there
be any noticeable change in rectal temperature. This will subsequently increase only
gradually as well and therefore initially lag marginally behind the intended progression.
This tracking error is gradually reduced and will in any event always remain below 0.5°.
This physiologic closed-loop circuit can obviously operate properly only if all
elements of this functional chain do perform their designated tasks as intended.
Assuming normal operations of the TECOTHERM NEO unit a number of additional
requirements need to be met:
The temperature regulating fluid must circulate at a flow rate sufficiently high to
ensure an efficient thermal transfer to or away from the patient. This process is
monitored by the unit and, if required, the operator will be alerted to initiate
appropriate corrective measures.
There must be sufficient thermal contact between the coolant fluid perfusion mattress
and the patient, as any change in mattress temperature may otherwise have no or
only limited effect on rectal temperature. It is of crucial importance for the operator to
position the mattress correctly and in accordance with the operating instructions (see
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8.7). The equipment can detect any fault in this respect only after lapse of the
response period of approx. 30 minutes, at the earliest, if despite constant adjustment
of mattress temperature the expected reaction in rectal temperature does not occur
and the rectal temperature eventually moves outside the permissible range of +/- 0.5°
around the target value. Only at that point in time will a temperature alarm be
activated.
Rectal temperature, as the measurement ultimately to be regulated, must be
recorded accurately. Incorrect measurements taken over an extended period of time,
regardless of cause, would immediately result in an unwanted change in the patient’s
actual core body temperature.
Example: An incorrectly placed rectal probe (e.g. slipped out) will record a temperature
lower than the actual core body temperature, since the rectal probe will now measure the air
temperature in proximity of the rectum. The current temperature measurement is shown on
the display. This temperature will in fact be lower than the rectal target temperature of
33.5°C. Consequently there is now a deviation in temperature (cause). This will immediately
result in an increase in mattress temperature (effect), since the unit’s control system will
work to again increase the core body temperature, which is now perceived being too low.
Upon activation of the alarm, at least, the operator can conclude from the low rectal
temperature recording shown on the display that the rectal probe may have slipped out and
will need to check this immediately.
6.2
Fallback mode
Amongst various possible causes which may lead to a malfunctioning of the physiologic
closed-loop circuit the systematically false recording of rectal temperature would be the
most disadvantageous, especially if it went unnoticed for an extended period of time.
Only this kind of false measurement would lead directly to the wrong core body
temperature for the patient. Such false readings can have a number of different causes:
incorrect placement of the rectal probe, e.g. slipped out
excessively high levels of electromagnetic interference from the environment
deficiencies in contact(s) at plug connections
defective rectal probe.
Unfortunately it is not possible to permanently monitor the rectal probe with the aid of a
second control probe, as the insertion of 2 rectal probes would be impossible in the
case of an infant. The otherwise recommended control by means of an additional skin
probe is not sufficiently accurate and too exposed to potential external impact for such
readings to be used in arriving at an informed decision. For these reasons measuring
results taken from the rectal probe are checked as to plausibility, whereby it will depend
upon the relevant stage of treatment as to what range of values for rectal temperature
recordings will be classified as being plausible and therefore acceptable. In the case of
measurements occurring systematically outside this specified range of acceptance
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TECOTHERM NEO will stop operating as a physiologic closed-loop circuit and
instead switch into fallback mode. The operator will be alerted and informed about the
current status and subsequently needs to decide upon an appropriate course of action.
Depending upon the stage of treatment a choice of suitable options will be given for the
unit to immediately resume operations. The operator can now follow these prompts or
make changes according to his own assessment of what actions may be required.
The key characteristic of the fallback mode is, that the required mattress temperature
will no be longer calculated by the temperature control system, but that it now needs to
be specified by the operator. In order to be able to take an informed decision under
these circumstances the operator immediately needs to arrange for alternative methods
of continuing a reliable recording of the patient’s rectal temperature, completely
independent from the TECOTHERM NEO system.
Although it will generally be possible to continue the current treatment process up to the
end entirely in fallback mode, one should always try to identify and eliminate the actual
cause of any false measurement. If no obvious reasons can be detected a replacement
of the rectal probe is recommended. As soon as acceptable measurements are
available again the unit will switch back automatically into the physiologic closed-loop
circuit operating mode and the operator will be advised accordingly. Only in rare cases
is it possible, that measurements may again be correct but still marginally remain
outside the valid range of acceptance. If the operator can see that the measurements
are indeed correct and there is still no automatic reversal, then this reversal can be
prompted through use of the “Servo” button.
6.2.1 Plausibility limitations in rectal temperature measurement
In accordance with the designated applications for the TECOTHERM NEO system (see
1.1) it would be possible in the extreme case for the rectal temperature of a “patient”
(not necessarily an infant!) to vary between 30°C and 38°C, at the beginning of the
treatment cycle. Initial temperature recordings between 29°C and 39°C are
consequently categorised as plausible readings. In the case of measurements outside
this range the control system cannot be started and activation will be denied, with
corresponding notification.
This comparatively broad range of tolerances, however, does not entail any untenable
elements of risk. On the one hand it can be assumed, that intensive care and monitoring
of the process is safeguarded during the initial stages of treatment, when the rapid
achievement of stable conditions is the primary objective. The range of acceptable
tolerances on the other hand is rapidly reduced following the initial stages of treatment
until a status of stable condition has been reached. From that point forward the
acceptable range of tolerances will be merely 1° above or below the corresponding set
target value. In the event of adjustments being made to the relevant target values the
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corresponding threshold values will change accordingly, e.g. they will rise during the rewarming phase at the same speed as the rectal temperature target value.
Besides the monitoring of compliance with these absolute tolerance thresholds rectal
temperature measurements are also checked as to their speed of change. The
threshold value in this respect is 0.3°/minute. Any changes faster than this, as in the
case of the probe having slipped-out, will be read and evaluated as non-plausible and
will trigger the switch to fallback mode.
6.2.2 Operations during fallback mode
As soon as the fallback mode has been activated, due to an infringement of tolerance
thresholds, the operator must intervene and determine how the mattress temperature is
to react from that point on forward. In this context it very much depends on the current
stage of treatment in deciding on how best to proceed in an expedient manner.
Correspondingly parameters are set for immediate activation of the fallback mode which
will, at least initially, not result in any additional exposure to risks. The operator will need
to adjust these parameters to prevailing conditions. With the aid of the graphic display
the operator can obtain a good indication from the diagram of the progression of
mattress temperature up to that point. Only once these steps have been taken is it
advisable to commence with any trouble-shooting efforts or even a replacement of the
rectal probe, in order to restore automatic operations as quickly as possible.
Depending on the current stage of treatment two essentially different types of
parameters and optional settings are available for operations in fallback mode.
If the rectal temperature is to be either kept constant or to be adjusted to a specific
value as quickly as possible, then the mattress temperature will be used as an
immediate control parameter which can be reset, if required, at any time.
During the initial phase of rapid cooling down to e.g. 33.5°C the pre-defined setting for
fallback mode will be a mattress temperature of 20°C. This will initially ensure that the
cooling down process, once initiated, will be continued. Depending on how far the
cooling down process has progressed up to this point, the temperature level of 20°C
may still be too high or otherwise already too low. This needs to be assessed by the
operator on the basis of an independent measurement of the patient’s actual rectal
temperature and the temperature will subsequently need to be adjusted accordingly. As
soon as the (independently measured) rectal temperature does approach the target
value of 33.5 °C additional adjustments to mattress temperature will become necessary,
in order to stabilise the temperature at 33.5°C and to prevent any further cooling down
of the patient.
In phases during which the rectal temperature is to be kept constant, e.g. at 33.5°C or
finally at 37°C, the pre-setting for the mattress temperature will be the same as that for
the rectal temperature to be maintained at a constant level. Depending on ambient
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conditions as well as the patient this may be marginally too high or somewhat too low.
The progression of mattress temperature up to that point, as shown in the diagram, will
provide useful guidance in this respect for corrective measures to be taken. If the
fallback mode continues to hold any longer, the operator will again have to assess, on
the basis of independently taken readings of the patient’s rectal temperature, whether
the choice of mattress temperature has been correct.
Different criteria do apply during treatment phases when the rectal 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 rectal temperature. A correspondingly accurate automatic
re-warming can schematically be illustrated as follows:
40
35
30
Rectal set temperature
Rectal measured temperature
Mattress temperature
time
25
In practice, however, the mattress temperature will not always need to be exactly 1°
above the rectal temperature and depending on the patient it may be even higher, as
well as lower, than the rectal temperature. Certain fluctuations may also be due to
interference, as indicated in the left segment of the diagram.
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If the fallback mode is activated following parameters are applied: the target value for
the mattress temperature will be set at the currently applicable target value for the rectal
temperature. In further progression it will gradually rise at the same speed at which the
rectal temperature is set to increase, as schematically shown in the following illustration:
40
35
FALLBACK MODE
automatically activated
30
Future scheduled Rectal set temperature
Rectal measured temperature
Future Mattress set temperature, Shift = 0 (default)
time
25
Comparing this illustration with the preceding one it becomes apparent, that the predetermined parameters cannot produce in the originally desired progression in rectal
temperature: Mattress temperatures would systematically fall 1° short of requirements.
In these cases the operator therefore is given an option to offset the future progression
of mattress temperature by an appropriate margin (maximum up to ±3°). The following
graphic illustrates how treatment would progress once the operator had interpreted the
progression of mattress temperature up to that point correctly and adjusted the system
accordingly to the appropriate level of offset:
40
35
FALLBACK MODE
automatically activated
30
Future scheduled Rectal set temperature
Rectal measured temperature
Future Mattress set temperature, Shift = +1.0 (good choice)
time
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7.
TECOTHERM NEO Hypothermia System
TECOTHERM NEO Hypothermia system, components and accessories:
TECOTHERM NEO device
Application parts like mattresses, cooling wraps, cooling pads
Temperature probes with connectors
Extension cables for single use Temperature probes
Hose set, thermally 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 interlayer
Electrical Power cord, up to 2,5 m
Warning: The use of accessories other than those specified in this Instruction for Use,
in particular Power cord, Temperature probes and their Extension cables, may result in
increased emissions or decreased immunity of the TECOTHERM NEO Hypothermia
System.
Warning: Accessories specified for use with TECOTHERM NEO, especially Power
cord, Temperature probes and their Extension cables, should not be used with other
medical electrical equipment or systems. This may result in increased emissions or
decreased immunity of the medical electrical equipment or system in question.
Optional accessories:
Repair set for small mattress defects like punctures and flaws
Fluid Emptying Aid for mattress
Storage boxes
TECOTHERM NEO Cooling Wrap TNEO PAD M for total body cooling of neonate and
infants for Multiple Use and mattresses for Total Body Cooling are Therm Aqua Pad
30 x 45 cm (small size), 50 x 90 cm (medium size), see section 7.8 .
Interlayer separate mattresses / wraps from patient body preventing intimate direct
contact.
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For total body cooling treatment the TECOTHERM NEO device pumps TECOmed along
the hydraulic lines through mattresses / wraps or pads to lower or increase body core
temperature to the set value. Operators may preselect the most appropriate treatment
procedure and target temperatures.
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 the more cooling or heating power is to be supplied by the
TECOTHERM NEO device.
The circulating liquid extracts heat from the patient or delivers heat to him. Circulation is
monitored by the controlling system. Heating and cooling rates also are monitored by the
microcomputer of the controlling system and checked for observing defined limits.
Treatment procedure temperatures for inducing hypothermia in neonate are strictly limited
Rectal Temperature standing for BCT
(lower limit / upper limit) in the treatment modes I and II
Mattress temperature
12°C / 39°C
Device internal temperature alarm limits
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32°C / 38°C
10°C lower limit
41°C upper limit
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7.1
TECOTHERM NEO operating modes
TECOTHERM NEO is designed as a physiologic closed- loop control system PCLCS,
see section 6.1.
Note All parameters can be changed from set position at ANY TIME should the need
arise. Select menu mode “Options” .Changes will be stored on the TECOTHERM NEO
and can be seen on later analysis.
Three treatment and operation modes of TECOTHERM NEO
I
Programmable Complete Treatment Mode (Servo controlled)
II Servo Control Mode (constant rectal temperature)
III Constant Mattress Temperature Mode
Note The operator can permanently follow the Rectal Temperature on the display
screen, see section 7.3.
7.1.1
Programmable Complete Treatment Mode (Servo controlled),
Treatment profiles
temperature
System is designed for inducing hypothermia in a patient by total body cooling. Details
for initial operation see section 8.
Note This mode with its target temperatures and
profiles is based upon the TOBY Study protocol
(see reference) for inducing hypothermia in neonate
suffering from Hypoxic Ischemic Encephalopathy.
time
TOBY protocol recommends a set target rectal
temperature of 33,5°C (default), then in treatment section 2 holding it constant for 72 h
followed by a linear increase to 37°C over at least 7 h in treatment section 3.
Treatment mode I generally allows selecting and setting rectal temperatures within a
range 32°C to 38°C. For treatment sections 1 and 2, however, setting is limited to
32 33,5°C 35°C. Duration of treatment section 2 can generally be set within
1 to 100 h, and in treatment section 3 between 1 and 24 h.
Temperature is accurately adjusted and finely tuned in all treatment sections.
All the pre-defined standard values of temperatures and durations as recommended by
the TOBY protocol may be modified to some extent by the user prior to starting the
treatment as well as later on whilst treatment is already running.
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Within “Servo Control Complete Treatment Mode“ the user can set
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, this new settings will get the next free treatment profile number
(from 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 available a further option to declare
this profile as the future default. Accepting this option with "Yes", in the future each
new call of this treatment mode will offer exactly this set of defaults. So treatment can
be started immediately, without first having to make any changes.
Once the user has created at least one own treatment profile, when selecting the “Servo
Control Complete Treatment Mode” in addition to the displayed temperatures and times
corresponding to the profile declared as standard, the option to choose another profile
will be offered. The corresponding specifications are each displayed immediately. So
the user can see the temperature and time defaults the treatment would proceed with.
In the delivery state of TECOTHERM NEO system there exists just the profile № 0 with
the above mentioned standard specifications according TOBY protocol. This profile can
not be overridden, it always remains unchanged. Any changes can only be saved into a
user-defined profile. If there is no more free number available (9 profiles have been
created already), only profile № 9 can be redefined.
Of course, the process of creating a treatment profile can be canceled at any time. In
any case, the treatment will always be performed using the temperature and time
settings that are shown on the display at the time of pressing the button "Start".
During the treatment, temperature and time settings still can be changed if necessary by
pushing the "Options" button. However, these changes can not be saved in profiles
during the course of treatment. They apply only to the currently running treatment.
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