TECOTHERM NEO Instructions for Use sw ver 063-02.18 Ver 21.1 June 2019

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TECOtherm NEO Hypothermia

System

Instructions for use of devices from software version 063/02.18

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Note:

Before use, read this information carefully to familiarize yourself with the system. This is the only

way to ensure safe and proper use of the TECOtherm NEO hypothermia system.

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Inspiration Healthcare Ltd

2 Satellite Business Village, Fleming Way

Crawley, West Sussex RH10 9NE, UK

T +44 (0)1455 840 555

F +44 (0)1455 841 464

E info@inspiration-healthcare.com

W inspiration-healthcare.com

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5.2.2.2

Fallback mode in the warming phase ............................................................ 25

Installation of the device and operation ............................................................................. 26

Commissioning ........................................................................................................ 27

Filling/Refilling/Emptying of Mattress and TECOtherm NEO ................................... 27

6.2.1

Filling process ..................................................................................................... 27

6.2.2

Refill process ....................................................................................................... 29

6.2.3

Emptying TECOtherm NEO and mattress............................................................ 29

Commissioning and Operation of the TECOtherm NEO System .............................. 30

6.3.1

Starting Treatment ............................................................................................. 32

6.3.2

Monitoring during treatment ............................................................................. 33

6.3.3

Ending treatment ................................................................................................ 33

6.3.4

Displaying and exporting treatment data ........................................................... 34

Switching off ....................................................................................................................... 34

Cleaning .............................................................................................................................. 34

Cleaning the outside of the TECOtherm NEO device ............................................... 35

Cleaning the outside of the mattress and hose kit .................................................. 35

Cleaning the outside of temperature sensors ......................................................... 35

8.3.1

Reusable temperature sensors ........................................................................... 35

8.3.2

Temperature sensors for single use .................................................................... 35

Transport............................................................................................................................. 36

Storage and shelf life .......................................................................................................... 36

Troubleshooting .................................................................................................................. 36

General information on the alarm and monitoring system ..................................... 36

System alarm ........................................................................................................... 37

Temperature alarm.................................................................................................. 38

Flow rate alarm........................................................................................................ 40

Fluid level alarm ...................................................................................................... 40

Power Failure/Mains Outage Alarm ........................................................................ 41

Maintenance and Service .................................................................................................... 42

General Notes .......................................................................................................... 42

12.1.1

Preventive maintenance ..................................................................................... 42

12.1.2

Software updates................................................................................................ 43

Disposal ............................................................................................................................... 43

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Technical Specifications ...................................................................................................... 43

Electromagnetic Compatibility (EMC) ..................................................................... 45

14.1.1

Guidelines and manufacturer’s declaration – Electromagnetic interference

emission 45

14.1.2

Guidelines and manufacturer’s declaration – Electromagnetic interference

emission 46

14.1.3

Guidelines and manufacturer’s declaration – Electromagnetic interference

emission 47

14.1.4

Recommended safe distances between portable and mobile HF

telecommunications equipment and TECOtherm NEO ...................................................... 48

Service Information ............................................................................................................ 49

I.

APPENDIX – Equipment and Accessories ............................................................................ 50

II.

APPENDIX – Internal cleaning ............................................................................................. 51

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General information

Signs and symbols

Important information

Fluid level too low

Attention, important notice! Warning!

Acoustic alarm paused

Caution, electric current!

Mains failure, power failure

(separate LED display)

Caution, do not touch contacts!

Applied part type BF

Follow the instructions for use!

SF

Internal system error

(separate LED display)

Do not dispose of with household

waste!

Date of manufacture

R

Socket for rectal temperature sensor

Manufacturer

S

Socket for skin temperature sensor

Serial number

"Switch on" button

Temperature alarm

CE marking to declare that the product

complies with applicable EU

requirements

Flow rate alarm

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Instructions for safe use

TECOtherm NEO is intended for use by healthcare professionals only.

Modifications to TECOtherm NEO are not allowed!

Only the accessories listed in the Annex and specified for use with

TECOtherm NEO must be used; otherwise correct function is not

guaranteed!

The device may only be opened by authorized personnel. There is a risk of

electric shock.

If the device is in operation, the user must not simultaneously touch the

patient and metallic device parts (e.g., sockets of plug contacts, protective

conductor-connected metal parts of the rear side, or contacts of fuse

holders).

The two sockets for the temperature sensors on the front of the device and

the USB socket on the back are marked with the ESD warning sign. They are

sensitive to discharges of static electricity; their contacts must not be

touched by fingers or tools.

When plugging in the temperature sensors or the USB stick, the following

ESD protection measure is required:

Touch the fan protection grid on the rear of the device with your other hand

first. It is necessary to train all persons working with the TECOtherm NEO

with regard to the importance of the ESD warning sign and ESD protection

measures. In addition to the protective measure prescribed above, this

training should also contain general information on the occurrence, possible

effect and prevention of electrostatic charges.

1.2.1

Indications of hazardous substances

TECOtherm NEO and application parts do not contain any parts of

•

derivatives of human blood or human or animal tissue

•

Latex

Application parts for TECOtherm NEO do not contain PVC with DEHP plasticizer.

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Intended Use Of The Device

Intended Use

The TECOtherm NEO hypothermia system is used for the targeted, precisely controlled and

comfortable stationary temperature treatment by means of a mattress, with which the

temperature control (cooling or warming) of the entire body or of body parts takes place as a

function of the therapy objective. The main application is induced hypothermia for the

treatment of hypoxic ischemic encephalopathy (HIE).

The manufacturer assumes responsibility for basic safety, reliability and

performance of the TECOtherm NEO system if:

•

•

•

The existing electrical installation at the installation site complies with

the requirements of the user manual as well as the legal and normative

requirements.

The installing and commissioning has been carried out by authorized

personnel.

The TECOtherm NEO system is operated in accordance with the

instructions for use.

Contraindications for use/side effects

No general contraindications are known. The following instructions must nevertheless be

observed by the user:

Therapeutic whole body hypothermia is a systemic treatment method. Be careful

when choosing the target temperatures during cooling. For re-warming, select

low speeds to slowly bring the body to the core temperature of 37° C.

The heart rate of the patients must be monitored. Patients with cardiac rhythm

disorders or very low heart rate require particularly careful monitoring.

Patients with known hypersensitivity to cooling and warming must only be

treated under supervision.

Open or infected wounds/burns, rashes and other affected regions of the skin

must not come into direct contact with the application parts of TECOtherm NEO.

Cooling can cause shivering to a patient. Shivering counteracts the cooling of the

body. The device registers this, controls against it and reports an alarm if

necessary.

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Requirements for operators and users

TECOtherm NEO is intended for use by healthcare professionals only.

The TECOtherm NEO may only be used and operated by persons who meet the following

qualifications and requirements:

•

Medical training

•

Work experience in intensive care, especially for use in neonatological and child

intensive care units (ICU)

•

Experience in dealing with medical-electrical devices and systems

•

Instruction and training in the use of TECOtherm NEO before commencing treatment

by the manufacturer or an authorized representative. The sales and service partners

provide instruction and training measures and inform about necessary updates of the

software. Information is also provided about design updates and technical

improvements.

As an operator or user, you must be familiar with the TECOtherm NEO operation

and possible troubleshooting BEFORE USE. Read the instructions carefully. Users

must be familiar with the modes of operation and procedures of hypothermia

treatment.

The user is required to carefully check the data entered or selected in the menu

for correctness and appropriateness before starting hypothermic treatment.

The user is responsible for setting a suitable mode and for setting the required

parameters of the treatment.

Environmental Requirements

For proper operation, the following conditions must be observed during proper use:

The room temperature should not exceed 27 °C or fall below 5 °C for prolonged

time periods. Otherwise, the lowest adjustable temperature is no longer reached,

particularly in the case of large mattresses. The system no longer achieves its full

performance.

The device must be protected against moisture (e.g., splashes) and protected

against humidity and splashes during operation.

The permissible relative humidity during treatment is 30%–80%.

The device must not be operated in rooms where combustible gas mixtures

occur, e.g., anesthetic with oxygen or nitrous oxide N2O.

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In the vicinity of the TECOtherm NEO, no equipment, devices and equipment may

be in operation or put into operation during treatment that:

•

Generate ultraviolet radiation

•

Generate infrared radiation

•

Generate strong electromagnetic interference with high intensity (e.g., HF

surgery equipment or magnetic resonance tomographs)

•

Generate or trigger mechanical shocks or shaking or strong vibrations

Introduction and Brief Description

The TECOtherm NEO device pumps temperature regulation fluid (temperature control medium)

circulating from the device through heat-insulated hoses to the treatment mattress and back

into the device. The aim is to bring the core temperature of the patient wrapped in the mattress

to the target temperature. The ACTUAL body core temperature is measured via a rectal

temperature sensor and compared with the SETPOINT temperature. Depending on the deviation

of the ACTUAL temperature from the SETPOINT temperature and the heating or cooling capacity

of the device, the temperature of the circulating fluid is automatically adjusted by the

TECOtherm Neo.

If necessary, the skin temperature of the patient can be monitored with the aid of an additional

skin temperature sensor. However, the skin temperature is not a control variable for the control

system.

Target temperatures and treatment times can be user defined within certain limits (cf. “14

Technical Specifications“).

System Description

Overview of system components

The TECOtherm NEO hypothermia system consists of at least the following components:

Designation

Designation

TECOtherm NEO device,

incl. installed software

Power cable

Mattress

Constant-temperature

medium

Hose kit

Sets and controls temperature and data storage

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Connects the device to the mains

Serves patient temperature

Flows through the mattress, serves for temperature control

Connects the mattress to the device, creating a circulating

fluid cycle.

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Designation

Designation

Refill sets

External rectal temperature

sensor

Used to fill the system with temperature regulation fluid

Controls and checks the core body temperature

Optionally, the following accessories can also be used:

Designation

Description

Fleece cover cloth

Used to protect reusable mattress or patient (see section

(for reusable mattresses)

4.5 Cover cloth (interlayer))

Mattress repair set

Set for repairing minor defects on the mattress

External skin temperature

Used for optional skin temperature measurement

sensor

Only the accessories specified in “I APPENDIX – Equipment and Accessories“

must be used with TECOtherm NEO. This is the only way to ensure safe

operation of the hypothermic system!

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TECOtherm NEO device

4.2.1

TECOtherm NEO – Front Side

No.

1

2

3

4-6

7

8

9

Designation

Switch-on button

Power failure status LED

“System error” status LED

Function keys

Key for menu arrow ▼

“Alarm mute” key

Key for menu arrow ▲

10

Coupling connectors for refill set

11

Coupling connectors for hose kit

R

S

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Connector socket for rectal

temperature sensor (R= Rectal)

Socket for skin temperature sensor

(S = skin)

Description

Switches the device on.

lights in case of power failure

lights in case of system errors

Execute the action options displayed on the screen

Moves cursor down or decreases numerical value

Mutes the acoustic alarm temporarily

Moves cursor up or increases numerical value

Serves for connecting the refill set for filling/refilling

temperature regulation fluid

Used to connect a hose kit. The liquid flows out of the

device via the left connection and returns to the device

via the right connection.

Used to connect a rectal temperature sensor

Used to connect a skin temperature sensor

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4.2.2

TECOtherm NEO – Rear Side

12

13

14

No.

12

Designation

USB port

13

Fuses

14

Mains plug socket

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Description

Connects a USB stick to store data

behind the panel of the mains plug socket: 2 replaceable

fuses (cf. type plate)

Connects a power cord to the power supply

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4.2.3

Display Menu

The menu is shown via the display. Individual menu items can be selected using the function

keys and menu arrow keys. The starting point and end point for navigation is always the main

menu. Selected menu items are highlighted in turquoise.

TECOTHERM NEO Main Menu

Highlight and Select Function Required:

Servo controlled complete treatment mode

Servo control mode (constant rectal temperature)

Constant Mattress Temperature Mode

Alarm check

Display and export of treatment data

Service

Language

Power Off

Ser.-Nr. 2019/13/06

Rev. 063/02.18

Select

Illustration example, menu language: English

All menu items are accessible to the user except for the SERVICE menu item in the main menu.

This is only accessible with a password for authorized service technicians.

Acoustic alarms are optically supported by symbols on the display. Important instructions, notes

and errors are communicated to the user in turquoise POP-UP windows.

Power cable

The power cable is used to connect the TECOtherm NEO to a protective contact socket for power

supply.

The power cable is only permitted for connection to protective contact sockets

with 100-130 V or 200-240 V and 50-60 Hz. The power cable must have a length

of 2.5 m.

Mattress

The mattress is used for the whole body temperature control of patients, in particular of

newborns and infants. It is connected to the TECOtherm NEO via the hose kit, and temperature

regulation fluid flows through it. To improve the temperature control of the patient, a mattress

can be wrapped around the body as required and closed with straps on the fastener loops.

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Mattresses are available for single and multiple use. Details are listed in Appendix “I APPENDIX

– Equipment and Accessories“. Please feel free to contact our Service Department.

The device with connected mattress must not be filled under pressure. The

mattress must remain flexible and soft so that the patient does not get pressure

marks.

Direct contact of the mattresses with the patient's skin should be avoided,

especially in the case of newborns. A suitable cover cloth is to be used on the

mattress; cf. “I APPENDIX – Equipment and Accessories“.

Fastener

loops

Coupler plug

Head

section

Fastener

loops

Example figure: Disposable mattress

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Cover cloth (interlayer)

The cover cloth is used for the mutual protection of patients and mattresses.

On the one hand, the patient is protected from contact with temperature regulation fluid in the

event of a leakage from the mattress, and on the other hand, the mattress is protected from

possible contamination by the patient's body. The cover cloths to be used are listed in section

“I APPENDIX – Equipment and Accessories“.

When reusable mattresses are used, the use of a thin, moisture-impermeable

fleece cloth (coated on one side with plastic) is mandatory for the protection

of patients and mattresses.

Hose kit

The hose kit is used for coupling the mattress to the TECOtherm NEO device and consequently

produces the circulation of the temperature regulation fluid.

The hose kit consists of two inner liquid-conducting hoses and the jacket hose for thermal

insulation. The standard length of the hose kit is 2 m. All couplings are self-sealing.

One of the two hoses of the hose kit is marked blue at both ends. The blue markings indicate

which mattress side is connected to which device socket. This facilitates the determination of

the direction of flow between the device and the mattress, since the liquid flows out of the

device to the left hose socket and is returned via the right hose socket.

Coupler plug

Coupling connectors

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Refill sets

The TECOtherm NEO device can be filled or refilled with temperature regulation fluid using refill

sets. The refill set consists of a specially prepared 500 ml container with two connecting hoses

and self-sealing coupling plugs.

External temperature sensors

TECOtherm NEO has connections for a rectal temperature sensor and an optional temperature

sensor for measuring skin temperature.

The body core temperature in the rectum can be measured via the rectal temperature sensor

and the temperature regulator can be controlled. The sensor is connected to the device via the

socket marked "R“.

A skin temperature sensor can be used as a reference sensor if required. It is used for

independent temperature monitoring of the patient, but is not necessary for the operation of

the device and is not used for control. It is connected to the device via the socket marked “S”.

Temperature sensors approved by the manufacturer of TECOtherm NEO are listed in the

appendix (cf. I APPENDIX – Equipment and Accessories).

The TECOtherm NEO hypothermic system must only be operated with

temperature sensors approved by the manufacturer.

Observe the correct assignment of the temperature sensors to the connector

sockets R (rectal temperature sensor) and S (skin/skin temperature sensor)

on the TECOtherm NEO device!

Ensure correct positioning of the rectal sensor in the patient! Fix and secure

the sensor against slipping out!

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Overview of the operating modes

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Description of the operating modes

Regardless of the operating mode, all temperatures as well as cooling and warming rates are

logged by the device. These can be read via a USB stick.

5.1.1

Automatic operation by program

The treatment in automatic operation according to programs is planned and defined in advance

by setting temperature-time profiles.

Program 0: In the factory default state of the TECOtherm NEO system, program no. 0 is set,

according to TOBY protocol with the following temperature-time profile:

Rectal in the treatment phase cooling

(therapy phase)

33.5° C

Duration of treatment phase cooling

(therapy phase)

72 h

Rectal temperature after warming

(temperature retention phase)

37° C

Duration of the re-warming phase

7h

This

program

cannot

be

overwritten;

it

is

stored

permanently.

The standard values for temperatures and times set in accordance with the TOBY protocol can

be changed by the user within certain limits before the treatment and also during the treatment.

Programs 1– 9: Nine programs can be created and saved individually by the user (to be saved as

programs no. 1 to no. 9). The parameters can be defined within the following limits:

Rectal in the treatment phase cooling

(therapy phase)

32 – 38° C

Duration of treatment phase cooling

(therapy phase)

1 - 100 h

Rectal temperature after warming

(temperature retention phase)

36 – 37° C

Duration of the re-warming phase

1 - 24 h

If changes are made to the specified temperatures or times before the start of the treatment,

the option is provided to store this new set of specifications as a separate treatment program. If

you select this option, this new set of specifications will receive the next available program

number (from 1 to 9) for identification. If the starting point for the changes made was an already

previously created separate treatment program, this can optionally also be redefined instead of

creating an additional treatment program.

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After a treatment program has been saved, the user is presented with the option to set this

program as the default. If this option is accepted by pressing “Yes“, this set of specifications are

provided in the future each time this operating mode is selected, so that the treatment can be

started immediately without having to make any changes.

Even after the treatment has been started, the temperature and time specifications can be

changed if necessary by calling the parameter screen with the “Options“ button. However, such

changes cannot be stored in the treatment programs during ongoing treatment. They only apply

to the current treatment.

In operating mode I, there are 4 treatment phases:

1. Phase/cooling phase: In the cooling phase, the temperature is regulated at maximum power

until the target value is reached. The target temperature is preset to 33.5° C in this automated

mode according to the TOBY protocol.

2. Phase/therapy phase: After the setpoint temperature has been reached, the control system

automatically changes to the therapy phase in which the setpoint temperature is maintained for

the duration preselected by the user.

If temperature deviations > 1° C occur during this phase when comparing the measured rectal

temperature with the setpoint temperature, this is detected by the monitoring system and an

alarm is triggered. The device automatically goes into the fallback mode (cf. “5.2 The Fallback

Mode – for Patient Safety“).

3. Phase/warming phase: As soon as the second phase is completed, the warming phase

automatically follows. It is also possible to switch to phase 3 in the “Options“ menu before the

second phase finishes.

The TECOtherm NEO system increases the body core temperature linearly until the selected

target temperature of the temperature retention phase is reached. In case of faults, the control

system reacts in the same way as in phase 2.

4. Phase/temperature retention phase (optional): After completion of re-warming, the

connection of a temperature retention phase is optionally possible. The TECOtherm NEO

maintains a previously defined constant rectal temperature in this phase. You can extend this

phase for any length of time. You can cancel the temperature retention phase by terminating

the program via the menu.

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5.1.2

Control to constant rectal temperature

When controlling to constant rectal temperature, the target rectal temperature (= body core

temperature) and the time until the target value of the rectal temperature is reached can be set

within the following limits:

Target value for constant rectal

temperature (target temperature for

therapy phase)

Time to reach target value

32 – 38° C

0 - 24 h

You can choose the duration of therapy at your discretion. After the end of each treatment

phase, the target temperature reached is maintained indefinitely.

If you select a time of “0 h” to reach a target temperature, TECOtherm NEO will try to reach the

target value as soon as possible. At selection of the duration, the user can also predetermine a

cooling rate/warming rate himself.

1. Phase/cooling phase: In the cooling phase (depending on the situation, this could also be a

warming phase), the device operates at maximum power to ensure that the target

temperature is reached as quickly as possible.

Alternatively, a time can be specified within which the target temperature is to be reached.

2. Phase/therapy phase: The target temperature is then maintained until the user interrupts

the therapy phase or makes a change to the target temperature (menu display: “Change

treatment”). After you manually change the target temperature, the control system will attempt

to reach the new target temperature as soon as possible or within a predetermined time.

3. Phase/warming phase: After the end of the therapy phase, the transition to re-warming must

take place. Once the new target temperature has been reached, it is kept constant (temperature

retention phase) until the treatment is terminated.

If plausibility limits are violated, the device perceives this as a fault and automatically goes into

the fallback mode (cf. “5.2 The Fallback Mode – for Patient Safety“).

The parameters within the defined framework must be defined by a trained

and experienced physician

The user must check for himself whether the intended treatment duration =

holding time has elapsed. If necessary, all parameters can be changed at any

time.

This operating mode is suitable for therapy periods, but not for complete

therapies.

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5.1.3

Setting to constant mattress temperature

When you set to a constant mattress temperature, the target mattress temperature (= body core

temperature) and the time until the target value of the mattress temperature is reached can be

set within the following limits:

Target value for constant mattress

temperature

Time to reach target value

12 – 39° C

0 - 24 h

This operating mode is usually executed without a rectal probe. However, it can also be executed

with a rectal probe, but the values of the rectal temperature here have only an informative

character and do not have a controlling effect on the control parameters.

The performance of the TECOtherm NEO is characterized by a very rapid cooling of the mattress

temperature, e.g., the device cools down the mattress (without patient) within 10 minutes from

the mattress temperature 20° C to 12° C. It should be noted that the core temperature of a

patient placed on the mattress cannot follow this temperature change not as quickly by far.

This operating mode is suitable for therapy periods, but not for complete

therapies.

In this operating mode, the treatment must be completely monitored by the

user and, if necessary, adapted.

The rectal temperature is no longer a reference variable!

In the "Setting to constant mattress temperature" operating mode, the body

core temperature must be monitored by a regular temperature

measurement!

The temperature should then be displayed on a suitable display and clearly

visible to the user.

Otherwise, a sufficiently accurate assessment of the actually achieved

lowering of the patient's core temperature is not possible.

The TECOtherm NEO large display permanently displays only the mattress

temperature, not the rectal temperature.

In the CHART on the display, you can follow the current rectal temperature

(if rectal sensor is used) and the skin temperature in the info boxes.

1. Phase/cooling phase: to achieve cooling as rapidly as possible, the lowest mattress

temperature that can be expected for the patient is set in the menu (“target value for constant

mattress temperature”). It should be borne in mind that a reaction of the body core temperature

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to a change in the mattress temperature can only be detected after about ½ hour.

The parameters within the defined framework must be defined by a trained

and experienced physician

2. Phase/therapy phase: The therapy phase now beginning with a constant mattress

temperature requires regular monitoring of the patient/his body core temperature by the user

to correct the mattress temperature if necessary.

3. Phase/warming phase: After the end of the therapy phase, the transition to re-warming must

take place. For this purpose, the mattress temperature must be changed manually and carefully

increased. For newborns, warm-up to normal temperature should take place at a rate of not

more than 0.5° C/h. This means that warming from 33.5° C to 37° C takes at least 7 hours.

The user must observe the size or weight of the patient when performing rapid warming. The

higher the size or weight, the slower the warming.

If plausibility limits are violated, the device considers this a fault.

The device automatically switches into the temperature alarm state.

The Fallback Mode – for Patient Safety

The fallback mode is used for safety and protects the patient in case of faulty operation. Among

all the causes which can lead to a faulty operation of the physiological closed-loop control loop,

systematic incorrect measurements of the rectal temperature would be the most serious, in

particular if they were not noticed over a prolonged period of time. Only these result directly in

an incorrectly displayed core temperature of the patient. Such erroneous measurements can

have various causes, e.g.:

•

Rectal sensor not correctly placed or slipped out

•

Rectal sensor defective

•

Contact problems on the plug connections

For protection, the measured values of the rectal sensor are automatically checked for

plausibility. If plausibility limits are exceeded, the device switches to the fallback mode and an

alarm sounds.

In the fallback mode, the required mattress temperature is no longer calculated by a

temperature controller, but must be specified by the user. To be able to make an informed

decision in such a case, the user must immediately obtain another temperature measurement

source, independent of the TECOtherm NEO, to continue to measure the rectal temperature of

the patient reliably.

In addition to the rectal temperature sensor, a skin temperature sensor can provide guidance.

However, it should be noted that the skin temperature only permits limited conclusions about

the core temperature.

Although it is basically possible to complete an ongoing treatment entirely in the fallback mode,

the user should always try to find and eliminate the cause of the incorrect measurements. If

there are no obvious reasons, changing the rectal sensor is recommended.

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If the user is convinced of the correctness of the function, the user should end the fallback mode

and return to the normal course of treatment. If the user does not do this, the device

automatically switches back into operation as a physiologically closed control loop as soon as

acceptable measured values are available again.

In the event of a failed rectal sensor, the sensor must be replaced.

Alternatively, the user must use an independent source of measuring the

rectal temperature.

5.2.1

Plausibility limits of the rectal temperature

In accordance with the purpose of TECOtherm NEO, it is considered possible that the rectal

temperature of a patient at the beginning of the treatment could be between 30° C and 38° C in

an extreme case. Accordingly, initial temperatures between 29° C and 39° C are still considered

plausible. With measured values outside of 29° C – 39° C, the control cannot be started, and the

start is rejected with appropriate information.

The acceptance limits are quickly narrowed after the start of the treatment until the treatment

phase is reached. From then on, only deviations of a maximum of 1° C from the respectively

valid rectal setpoint value are accepted.

In addition to monitoring these absolute limits, the measured values of the rectal temperature

are also checked for how quickly they change. A maximum of 0.3° C/minute is considered

plausible and consequently acceptable. Faster changes, such as would occur when the sensor

slides out, for example, are evaluated as not plausible and also trigger the fallback mode.

5.2.2

Working method in the fallback mode

How the parameters for a continuation of this mode are to be changed depends on the status

of the ongoing treatment.

For immediate start-up of the fallback mode, parameter specifications are defined that do not

pose any danger initially. The user must evaluate these settings and change them if necessary.

The mattress temperature chart can be used for guidance. Only then is it advisable to

troubleshoot and possibly even replace the rectal sensor to return to automatic operation as

quickly as possible.

For each treatment phase, two fundamentally different types of defaults and setting options for

the fallback mode are available:

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Operating mode

Options in fallback mode

Automatic operation by

programs (Operation

mode I)

•

Control to constant rectal

temperature (Operation

mode II)

•

•

Control to constant

mattress temperature

(Operation mode III)

5.2.2.1

•

The device operates at a target temperature of 20° C until it is

manually set.

The user must manually set the mattress temperature between

12°–39° C.

The device works with the last set target temperature.

The user must manually set the mattress temperature between

12°–39° C.

Since no rectal probe is used, there is no fallback mode for operating

mode III.

Fallback mode in cooling phase

The fallback mode automatically sets a mattress temperature of 20° C. This ensures that

cooling is continued or maintained.

Depending on the cooling stage, 20° C can be too high or too low. The user must evaluate this

setting, using an independent measurement of the actual rectal temperature of the patient

and correct it accordingly. The following options are available in the control menu:

1.

2.

3.

4.

Modify the running program

Start the warming phase immediately

End treatment, close log

Test alarm function

5.2.2.2

Fallback mode in the warming phase

It is known that the rectal temperature changes with a time delay depending on the patient's

mass compared to the mattress temperature due to heat/cold losses, but usually at a certain

interval (e.g., ± 1-2° C) from the specified rectal temperature. Therefore, the mattress

temperature must be higher than the current rectal temperature in the warming phase.

If the fallback mode is activated, the setpoint value of the mattress temperature is first set to

the currently valid setpoint value of the rectal temperature and then rises slowly. The user can

then appropriately change the setpoint value of the mattress temperature by setting a shift of 3.0° C to +3.0° C in the menu.

The following options are available in the control menu:

1.

2.

3.

Modify the running program (individual setting of the mattress temperature by the user)

End treatment, close log

Test alarm function

Version: 21.1 18/06/2019

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