TECOTHERM NEO Instructions for Use Revision Nov 2015

Contents and abbreviations 1. 1.1 1.2 1.3 1.4 2. 3. 4. 5. 6. 6.1 7. 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 7.10 7.11 7.12 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

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Preface ... 4 Intended Use ... ... 4 Indications for Use………………………………………………………… 4 Contraindications for Use ... 4 Operators Profile ... 4 Information for Customers, Service & Technical support ... 5 Symbols, Indications ... 6 Warnings & Precaution ………………………………………………... 7 Safety & Reliability………………………………………………………… 8 TECOTHERM NEO Operating Function……………………………….. 10 Fallback mode……………………………………………………………… 10 TECOTHERM NEO Thermoregulation System………………………. 11 TECOTHERM NEO Operating Modes………………………………….. 11 TECOTHERM NEO System Information ... 13 Modules and Main Components……………………………………………14 Alarm System and Monitoring Features…………………………………...16 Indicators and Operation Key elements, Display screen………………..17 TECOTHERM NEO Rear Face…………………………………………….18 Indicating Temperatures…………………………………………………….18 External Temperature Probes ... 20 Fill- up set for Filling/Refilling fluid…………………………...…………….21 Mattresses ... 22 MENU and the User Interface / USB connection ... 24 Treatment Data Selection and Transfer/USB Socket…………………….25 TECOTHERM NEO System Putting into operation ... 26 Initial Set up/Initial Operation... 26 Pre-operation Check up ... 26 Initial Operation ... 27 Stop operation/Turn off device ... 32 TECOTHERM NEO System: Filling/Refilling Procedures ... 33 Draining a used mattress ... 35 Application of mattresses to patients ... 35 Hygienic Requirements ... 36 Cleaning and Disinfecting TECOTHERM NEO ... 36 Mattresses, thermally insulated hoses, tubing ... 36 Temperature Probes ... 36 Storage and Transport ... 37 Storage of the TECOTHERM NEO device ... 37 Storage of Mattresses ... 37 Transport ... 37

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11 11.1 11.2 11.3 11.4 11.5 11.6 12 12.1 12.2 12.3 12.4 13 14 15

Alarm system, malfunctions, incident management……………...38 System Alarm, System Failure ... 40 Temperature Alarm ... 43 Flow rate alarm ... 46 Alarm Fluid level low ... 49 Alarm No Mains Power ... 51 Fluid escapes from the TECOTHERM NEO System ... 53 Service, preventive maintenance, Software Update ... 54 Service & Maintenance ... 54 Replacement of fluid in the device ... 54 Check/calibration of temperature probes ... 55 Software Update ... 55 Disposal ... 56 Technical Data, TECOTHERM NEO Specification ... 57 EMC guidance for TECOTHERM NEO ... 58

Abbreviations IfU BCT

SF Mattress

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Instruction for Use Body Core Temperature, as measured via the Rectum or Esophagus using appropriate temperature probes System Failure Aqua Wrap/Mattress

1.

Preface

1.1 Intended Use The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective. The operator should be familiar with the operation modes and capabilities of the TECOTHERM NEO. Prior to use, carefully read this Instructions for Use (IfU). Note: The Manufacturer carries responsibility for basic safety, reliability and capability of the TECOTHERM NEO system only when   

local electrical installation fully meets the requirements of the IfU. operation is performed by authorized personnel. TECOTHERM NEO is operated according to the instructions and statements in this IfU.

1.2 Indications for Use The TECOTHERM NEO is a temperature management system for pediatric patients, indicated for controlling and monitoring patient’s temperature through conductive heat transfer. 1.3 Contraindications for Use No general contraindications are known. For possible adverse effects study the relevant treatment and therapy protocols. Avoid direct contact of mattress with fresh or non-closed wounds, infectious areas, areas with ulceration and abscesses, rash and burns. 1.4 Operators Profile TECOTHERM NEO is intended for use by healthcare professionals only. Operating a TECOTHERM NEO requires:  Experience in using life support and life sustaining equipment  Experience in using medical electrical equipment  Operator must be trained in the use of the TECOTHERM NEO before operating the device.

Note Operator should carefully check all set parameters for correctness before starting the treatment.

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2

Information for Customers Service & Technical support For Technical Support please contact: Inspiration Healthcare Ltd Phone: +44 - 1455 840555 Fax: +44 - 1455 841464 E mail: [email protected] Inspiration Healthcare Limited or authorized representatives will instruct the operation personnel prior to putting the equipment into operation. Additional information, technical support, additional manuals may be requested from Inspiration Healthcare Limited and any authorized distribution partner.

Authorized Distributor in the USA: Maxtec 2305 South 1070 West Salt Lake City Utah 84119 USA Phone: 385 549 8070 Fax: 801 943 6090 www.maxtec.com

Manufactured for Inspiration Healthcare Limited by: TEC COM GmbH Am Krümmling 1, Eingang B, D-06184, Kabelsketal OT Zwintschöna, Germany

Type label

TECOTHERM NEO Serial Number 2013 / 07 / 01 100-130 / 200-240 VAC 50-60 Hz max. 350 VA Class: I IP20 Made in Germany Fuses: 5x20mm 250VAC 100-130V: S4AH / T4AH 200-240V: S2,5AH / T2,5AH

Manufacturer: TEC COM GmbH, Am Krümmling Eingang B, D-06184 Kabelsketal OT Zwintschöna Germany 0494

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3.

Symbols, Indications

Important Information Attention, Caution, Warning Electrical Hazard ! Do not touch contacts! Applied Part Type BF

Consult Instructions for Use BCT (Rectal) Temperature Sensor socket

Skin Temperature Sensor socket

Key “Turn On” System failure

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)

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4.

Warnings & Precautions Warnings



Do not modify the TECOTHERM NEO in any way.



Do not open the device! Risk of electrical shock.



Repair and maintenance are restricted to authorized personnel only!



The TECOTHERM NEO device must be plugged to the mains using shockproof sockets. Mains voltage must be 100-130V or 200-240V with 50-60 Hz. Use only cord supplied with the device or a medical grade approved equivalent cord not longer than 2.5 m.



Caution: During operation and treatment: The operator must not simultaneously touch the patient and metallic device parts (plug/connector sockets, fuse contacts, grounded connected parts at the device rear).



Both temperature probe sockets on the front of the device and the USB socket on the rear are marked with ESD warning symbols. They are sensitive against discharge of static electricity, their electrical contacts should not be touched with the fingers or tooling. When connecting probes or USB stick to their sockets the following precautionary procedure is required: Before plugging, touch the fan protective grid at the rear with your other hand.



For a reliable and safe operation use only original components, applied parts and spare parts supplied or recommended by Inspiration Healthcare Limited or the Authorized Representative. Only Sterile Water should be used as circulating fluid.



 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" (for Body Core Temperature) and “S” (for Surface Temperature).  Ensure that Rectal and Skin Temperature Probes are correctly placed in/on the patient and are properly secured.  Do not use TECOTHERM NEO with, or in presence of flammable agents.

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5. Safety & Reliability Warning: Substitution of original parts or components of the TECOTHERM NEO system by parts or components which are not licensed by Inspiration Healthcare Limited or the Authorized Representative is likely to put the system and the patient at risk! Precautions Notes: Therapeutic Induced Total Body cooling is a systemic treatment method. Select target temperatures cautiously. Re- warming: Select low re-warming rates to smoothly reach normal BCT of 37°C. Patient body mass may severely influence re-warming. The larger the mass, the slower the re-warming. Portable and mobile RF communication equipment can affect medical electrical equipment. Observe the recommended separation distances in the EMC tables.  The TECOTHERM NEO device should be subject to regular maintenance and service.  Refill sterile water regularly every 2 months, see section 8.5.  Note: Circulation may stop, fluid flow stops. In such cases mattresses may cool patient down slowly. During treatment, (re- warming phase) patient may suffer from extraction of body heat back into the mattress. This must be addressed without delay.  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.  The unit must be placed in such a way that it could be easily disconnected from mains power. Removing the mains plug must always be possible.  The unit must be placed horizontally onto a 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 face and a wall or another limiting surface to ensure free outflow of the cooling air.  Do not place the device into small cabinet or onto small scale boards.  Do not cover the device!  The unit should be placed to avoid blowing air towards the patient.  The unit should be placed so that visual alarms are clearly seen and acoustic alarms are clearly audible.  Do not place mattresses and hoses onto hot or warm surfaces during operation.  Do not operate the device near intensive heat sources.

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Attention: Leave enough space around the TECOTHERM NEO so as not to obstruct passage of personnel. Ensure that hoses, cable cord, temperature probes etc. do not form obstacles.  Ensure that placement of TECOTHERM NEO does not create hazards for hands and fingers, or any other injuries.  Check mattress for visible damage.  Note: Place mattress onto a  10-20 mm thick foam material that has good thermal insulation during operation. Using an incubator When using an incubator to perform treatment:  Ensure there is enough space to properly place mattress. Otherwise kinking of tubing may occur.  Place the hoses with as few bends as possible. Fasten the hoses in such a way to avoid kinking of the tubing near the mattress. Note: Place mattress onto a  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 patient in a re-warming phase of the treatment. Indications for hazardous substances TECOTHERM NEO does not contain parts or substances originating from derivatives of blood or human/animal tissues. TECOTHERM NEO does not contain parts made of Latex or its derivatives. TECOTHERM NEO Applied Parts do not contain phthalates. Thermalizing Fluid is sterile water. Skin contact with sterile water is harmless. Ambient Conditions To ensure proper operation in normal use, pay attention to the following conditions  Protection The device should be protected from dampness and wetness  Do not operate device in rooms where flammable mixtures of anesthesia gases with oxygen, 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.  Relative Humidity during treatment should be within a range of 30% - 80%.  Ensure that during treatment/operation, no installations or devices are operating or are intended to operate next to TECOTHERM NEO which produce ultraviolet radiation, intense infrared radiation, strong electromagnetic radiation or mechanical shocks/vibrations.

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6.

TECOTHERM NEO Operating Function

6.1 Fallback mode If BCT measurements occur outside the range of acceptance, TECOTHERM NEO will stop operating as a physiologic closed-loop circuit and instead switch into fallback mode. Different criteria apply during treatment phases when the patient’s temperature is to be gradually adjusted at a pre-determined speed. It is known that in this case the mattress temperature will gradually change, at the same speed, albeit with a certain delay with regard to the pre-determined Body Core Temperature. In practice, however, the mattress temperature will not always need to be exactly 1° above the BCT and depending on the patient it may be even higher, as well as lower, than the BCT. User-Defined Treatment Profiles Within “Servo Control Complete Treatment Mode“ the user can set and store up to 9 (user-defined) Treatment Profiles. When changes are made to the default temperatures or times before the start of treatment, the user is given an option to save this new settings as a treatment profile. If selecting this option, the new settings will get the next free treatment profile number (1 to 9) for identification. If the starting point for the changes was a previously generated treatment profile, it can be redefined instead of creating another new treatment profile. After a treatment profile has been saved, there is a further option to store this profile as a future default. Once the user has created at least one treatment profile, when selecting the “Servo Control Complete Treatment Mode” in addition to the displayed temperatures and times corresponding to the profile declared as standard, the option to choose another profile will be offered. The process of creating a treatment profile can be canceled at any time. In any case, the treatment will always be performed using the settings that are shown on the display at the time of pressing the "Start" button. During treatment, temperature and time settings can be changed if necessary by pushing the "Options" button. However, these changes cannot be saved in profiles during the course of treatment.

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7 TECOTHERM NEO Thermo-Regulation System Components and accessories:  TECOTHERM NEO device  Applied part (mattress)  Temperature probe with connector  Hose set, thermally shielded to connect application parts to the device  Fill-up set, includes necessary components for filling/re- filling  Electrical Power cord, up to 2,5 m Warning: Accessories specified for use with TECOTHERM NEO should not be used with other medical electrical equipment or systems. Optional accessories:  Fluid Emptying Aid for mattress  Storage boxes  Chlorine Dioxide tablets for routine cleansing (available from device supplier) Treatment temperatures are strictly limited  Body Core Temperature 32°C/38°C (lower limit/upper limit) in the treatment modes I and II  Mattress temperature 12°C/39C Device internal temperature alarm limits: 10°C lower limit/41°C upper limit 7.1 TECOTHERM NEO operating modes Three treatment and operation modes of TECOTHERM NEO I

Programmable Complete Treatment Mode (Servo controlled mode)

II Servo Control Mode (constant rectal temperature) III Constant Mattress Temperature Mode Note: The operator can permanently follow the Body Core Temperature on the display screen. Treatment Mode I Programmable Complete Treatment Mode (Servo controlled mode) System is designed for cooling/heating and regulating the temperature of the patient. Treatment mode I allows selecting and setting target Body Core Temperatures within a range 32°C to 38°C. To start treatment follow and observe the instructions in the MENU. NOTE: All parameters can be changed from set position at ANY TIME should the need arise. Changes will be stored on the TECOTHERM NEO and can be seen on later analysis. In treatment mode I all temperatures/time dates are recorded/logged and can be read out/transferred to a USB stick, see section 7.13 for the USB port. Page 11 of 60

Treatment Mode II SERVO CONTROL Constant Rectal (BCT) Temperature Mode Target Body Core Temperatures 30° to 38°C. Each treatment section will result in the temperature being maintained until operator intervention. To start treatment follow the instructions of the MENU. Treatment section 1 Cooling-Down or Warming Phase Treatment section 2 Maintenance Phase NOTE: TECOTHERM NEO will not alarm the end of any section. The operator must observe whether the intended time of treatment has elapsed. Treatment Mode III NON-SERVO CONTROL Constant Mattress Temperature Mode When TECOTHERM NEO is run in the Constant Mattress Temperature Mode, to change body core temperature, an independent temperature measurement is required. Selectable mattress temperature range is 12°C to 39°C. In Treatment Mode III the operator is fully responsible for performing and selecting a treatment procedure. He has to select appropriate mattress temperatures and treatment times for cooling and re-warming. Attention Only the Mattress temperature is permanently displayed on the screen in the display feature (LARGE SIZE NUMBERS). Treatment Procedure Section 1 Cooling: Start treatment following the MENU instructions. Treatment section 2 Re- Warming NOTE: Patient body mass may severely influence the re-warming. The larger the mass the slower the re-warming. All temperatures/time dates are recorded/logged and can be read out/transferred to a USB stick, see section 7.13, USB port.

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7.2 TECOTHERM NEO Thermo-Regulation and Monitoring system Information. For the TECOTHERM NEO no ESSENTIAL PERFORMANCES have been determined. TECOTHERM NEO is a light- weight, efficient and powerful Thermo-Regulation and Monitoring system Options Dimensions Mass / Weight Operation modes:

Cooling/Warming, Normothermia 375 x 190/ 215 x 310 mm (W x L x H) 7,2 kg I Servo Control Complete treatment mode II Servo Control Constant Rectal Temperature III Constant Mattress Temperature Mattress temperatures for Total Body cooling / warming children up to 50 kg body mass +12°C to + 39°C Temperature constancy 0,3 °C Temperature accuracy 0,1 °C Body Core Temperature control range I 32°C.. 33,5°C..38°C II 30°C…. 38°C Hydraulic circulation system Fluid Reservoir capacity Fluid flow rate in operation Circulation System pressure Electrical power consumption

sterile water approx. 250 ml up to 300ml/ min, with mattress up to 500 ml/ min short circuited max. 0,5 bar < 350 W (mains 100-130V / 200-240V 5060Hz)

Applied Parts Rectal Probes

TCM1837A single use. TC-D-RB2A reusable.

Skin Probes

TC-D-SO6-RGA reusable.

Adaptor cable for disposable rectal probe

TC989803162-601 reusable.

Cool Wrap TC-MATT-NEO Material Dimensions Volume Mass (empty)

Reusable, Manufacturer Inspiration Healthcare PUR polyurethane, transparent 620 x 420 mm 300 - 350 ml fluid 155 g

Cool Wrap TC-MATT-DISP Material Dimensions Volume Mass (empty)

Single Use, Manufacturer Inspiration Healthcare PUR polyurethane, coated 620 x 420 mm 300 - 350 ml fluid 220 g

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7.3 Modules and Main Components       

Central Cooling / Warming Module Hydraulic Module for controlled circulation of fluid Micro Computer controlled Operating and Control Board, MENU, user interface Display for visualization of MENU operations and treatment / therapy scenario. Alarm and monitoring system Temperature probes

Detailed software is implemented. Indicators and operation key elements/buttons are clearly arranged at the front panel. Mains socket and sockets for USB are positioned at the rear side. Figure

TECOTHERM NEO Device

Central Cooling/Warming module The Central Cooling/Warming module is a thermoelectric based unit which cools or warms the circulating fluid. This module is controlled and monitored by means of a microcomputer in the Control Board and supplied by a modern efficient switching power supply. It is fan cooled to remove heat produced by the Peltier elements. It is operating exactly to reach the target temperatures adjusted by the operator, and hold them constant according treatment protocol.

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A large display serves as the user interface. MENU operations and treatment modes are visualized on the display screen. The operator either selects, confirms or modifies treatment modes, treatment options, operations and settings using MENU operation Arrow Keys to move to MENU entries. Pushbuttons below the display screen enable performing instructions like Select, Confirm, Cancel, Apply, Start etc. Currently selectable instructions and entries are highlighted turquoise. Display with MENU

Arrow Cursor Arrow keys

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7.4 Alarm System and Monitoring Features

Alarm symbols shown on the display are indicating system errors and failures

System failure.

SF

Temperature Alarm. Alarm No or restricted flow

Low fluid level Audible alarm, paused TECOTHERM NEO is equipped with detailed alarm and monitoring elements. Main purpose is monitoring and detection of temperatures and flow of the circulating fluid, of internal temperatures in the Central Cooling/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 above shown indicators appear on the screen. Details on indicators see section 7.5.

SF

Mains Power failure and certain internal system failures are indicated by LED indicators in the lower front panel, just below the display screen. For details see section 11 Alarm System.

Mains Cable Cord TECOTHERM NEO is powered via a medical grade cord to a shock-proofed mains socket with 100-130V or 200-240V and 50-60Hz. Cord should be up t o 2.5 m long and approved for shock proofed sockets only.

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7.5 Indicators and Operation Keys, Display screen Figure

TECOTHERM NEO front panel view

(1)

Pushbutton to power the device on, marked ”I“

(S)

Temperature Probe Socket

Skin Probe

(R)

Temperature Probe Socket

Rectal (Body Core Temperature) Probe

(4)

LED Indicator Mains Failure

(5)

LED Indicator System Failure “SF”

(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 indicated on display

(T 4)

Pushbutton

Arrow Key: menu upwards or increase value

(T 5)

Pushbutton

Pausing Audible Alarm

(T 6)

Pushbutton

Arrow Key: menu downwards or decrease value

(6)

Female Coupling / socket for connecting hoses or mattresses

(7)

Female Coupling / socket for connecting fill- up set

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7.6 TECOTHERM NEO Rear Face

(8)

Mains Socket

(9)

USB socket

7.7 Indicating Temperatures Running the 3 main treatment modes, treatment temperature is shown on the screen in a large size (display feature LARGE SIZE NUMBERS). Rectal temperature is displayed when selecting treatment mode I or II. temperature is shown when selecting treatment mode III.

Mattress

Treatment modes I and II As long as measured temperature deviates more than 0.5 °C from the Set Point the temperature is appearing RED. So, for example, if Set Point is 33.5°C a measured temperature of 36.4°C is displayed RED. Only when deviation is < 0.5°C color changes to GREEN.

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36.4

33.4

Set Point 33.5

Set Point 33.5

Treatment mode III As long as measured Mattress Temperature deviates more than 0.5 °C from the Set Point the mattress temperature is appearing RED. So for example if Set Point is 30.0°C a measured temperature of 34.1 °C is displayed RED. Only when deviation is < 0.5°C color changes from RED to BLUE.

34.1

30.2

Set Point 30.0

Set Point 30.0

60 seconds after starting treatment in each of the main treatment modes the display feature DIAGRAM is changed to the feature LARGE SIZE NUMBERS. Here shown for treatment mode II Servo Control Constant rectal temperature.

23.03.2010 35

35

30

30

25

25

20

20

15

15

1

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33.6

hour

Set Point 33.5

7.8 External Temperature Probes Patient Temperatures should be measured using approved calibrated Temperature probes. TECOTHERM NEO applies a Rectal Temperature probe and a Skin temperature probe: Reusable Rectal Probes (pediatric)

Type TC-D-RB2A, autoclavable

Single-Use Rectal Probe Adaptor Cable for TCM1837A

Type TCM1837A TC989803162-601

Reusable Skin Probe (pediatric)

Type TC-D-S06-RGA, with REDEL connector, autoclavable.

NOTE

Rectal probe and Skin probe connectors have their individually mating sockets R and S! Ensure correct connections!

Body core temperature BCT is measured with the rectal probe. Ensure that the probe is correctly inserted in the patient and that it is properly secured. Also ensure that the probe is properly connected to the TECOTHERM NEO socket marked R ! The second temperature probe (reference probe) is plugged to the TECOTHERM NEO socket S . It independently monitors a second patient temperature.

Figure

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TECOTHERM NEO with Temperature Probes