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DeRoyal TEMPLE TOUCH PRO TTP User Manual
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DeRoyal TEMPLE TOUCH PRO TTP User Manual

Non-invasive core temperature monitoring system
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Non-Invasive Core Temperature Monitoring System
USER MANUAL
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Marta toffaloni
April 23, 2025

hello , i just wonder if this product can be used for pediatrics/infants patients

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Summary of Contents for DeRoyal TEMPLE TOUCH PRO TTP

  • Page 1 Non-Invasive Core Temperature Monitoring System USER MANUAL...

  • Page 3: Table Of Contents

    Table of Contents Table of Contents 1. Temple Touch Pro™ (TTP™) - Introduction 1. Temple Touch Pro™ (TTP™) - Introduction 2. Intended Use 2. Intended Use 3. Warnings and Safety Notices 3. Warnings and Safety Notices 4. Temple Touch Pro™ - System Description 4.
  • Page 4 1 .Temple Touch Pro™ (TTP™) Introduction 1 .Temple Touch Pro™ (TTP™) Introduction The purpose of this document is to describe the proper way to The purpose of this document is to describe the proper way to setup, use and maintain the Temple Touch Pro™ (TTP™) system. setup, use and maintain the Temple Touch Pro™...
  • Page 5 The TTP™ MCU must be connected to the applied part The TTP™ MCU must be connected to the applied part connector of a safety approved medical grade vital signs connector of a safety approved medical grade vital signs monitor (VSM). The connection shall be made to the VSM monitor (VSM). The connection shall be made to the VSM input for applied part which is marked as CF applied part.
  • Page 6 16. Whenever you doubt the temperature reading provided by 16. Whenever you doubt the temperature reading provided by TTP™ system, confirm temperature reading with a separate TTP™ system, confirm temperature reading with a separate thermometer. thermometer. 17. When disposing the TTP SU, follow facilities policies and 17. When disposing the TTP SU, follow facilities policies and procedures for disposal of contaminated materials. procedures for disposal of contaminated materials. 18.
  • Page 7 NOTICES: NOTICES: The TTP™ system meets medical electronic interference The TTP™ system meets medical electronic interference requirements. If radio frequency interference occurs, requirements. If radio frequency interference occurs, connect the TTP™ system to a connect the TTP™ system to a power source.

  • Page 8: Temple Touch Pro™ - System Description

    4. Temple Touch Pro™ - System Description 4. Temple Touch Pro™ - System Description The TTP™ system continuously monitors the patient’s core The TTP™ system continuously monitors the patient’s core body temperature. The TTP™ system contains the following body temperature. The TTP™ system contains the following components: a Sensor Unit (SU), which is connected to a Sensor components: a Sensor Unit (SU), which is connected to a Sensor Connecting Unit (SCU) which is connected to the Monitor...
  • Page 9 The TTP™ Sensor Unit (SU) The TTP™ Sensor Unit (SU) The SU is a non-sterile, disposable sensing unit which is placed The SU is a non-sterile, disposable sensing unit which is placed on the patient’s temple from the initial stages of medical care on the patient’s temple from the initial stages of medical care (such as surgery preparation), and may be affixed to the patient’s (such as surgery preparation), and may be affixed to the patient’s temple until it is no longer required to monitor the patient’s temple until it is no longer required to monitor the patient’s core temperature (such as - upon discharge from PACU). core temperature (such as - upon discharge from PACU). The SU is comprised of a temperature sensor module, a bio The SU is comprised of a temperature sensor module, a bio compatible adhesive layer, with two isolation layers in between.
  • Page 10 The TTP™ Monitor Connecting Unit (MCU) The TTP™ Monitor Connecting Unit (MCU) The MCU receives data from the SU through the SCU and The MCU receives data from the SU through the SCU and transmits the information related to the patient’s core transmits the information related to the patient’s core temperature to the VSM.
  • Page 11 Table A.1 - LED Indication Description: Table A.1 - LED Indication Description: LED name LED name Symbol Symbol Color Color Functionality Functionality Location Location POWER POWER Yellow Yellow Turns ON when the Turns ON when the MCU is properly MCU is properly connected to a power connected to a power supply.

  • Page 12: How Does Temple Touch Pro™ Work

    5. How does Temple Touch Pro™ work 5. How does Temple Touch Pro™ work Core temperature is defined as the temperature of the blood Core temperature is defined as the temperature of the blood flow in the pulmonary artery. Under known parameters one can flow in the pulmonary artery. Under known parameters one can utilize Temporal Artery blood flow characteristics to derive the utilize Temporal Artery blood flow characteristics to derive the core temperature. core temperature.

  • Page 13: Setting Up Temple Touch Pro

    6. Setting up Temple Touch Pro™ 6. Setting up Temple Touch Pro™ Note! Note! Setup of the TTP system shall follow the sequence below: Setup of the TTP system shall follow the sequence below: Make sure the VSM is turned on and fully operative Make sure the VSM is turned on and fully operative according to the instructions provided by the VSM according to the instructions provided by the VSM...

  • Page 14: Instructions For Use

    7. Instructions for Use 7. Instructions for Use Ensure the MCU is connected to the VSM and to the Power Ensure the MCU is connected to the VSM and to the Power Supply (see section 6 above). Supply (see section 6 above). Ensure the patient’s temple is intact and use an alcohol Ensure the patient’s temple is intact and use an alcohol wipe to clean and disinfect the patient’s temple. Allow the wipe to clean and disinfect the patient’s temple. Allow the temple to completely dry (at least 2 minutes). temple to completely dry (at least 2 minutes).
  • Page 15 Peel the liner off the SU to expose the adhesive (The figure Peel the liner off the SU to expose the adhesive (The figure shows the bottom part of the SU). shows the bottom part of the SU). Bottom side Bottom side Figure 8 Figure 8 Place the center of the SU on the patient’s temple. Gently Place the center of the SU on the patient’s temple. Gently press the surrounding edge of the SU to ensure good press the surrounding edge of the SU to ensure good adhesion to the skin. adhesion to the skin. Figure 9 Figure 9 Limit use of the SU to 24 hours in order to reduce the risk of skin Limit use of the SU to 24 hours in order to reduce the risk of skin irritations. irritations. Connect the SCU to the MCU. The CONNECTIVITY LED will Connect the SCU to the MCU. The CONNECTIVITY LED will start blinking, indicating the MCU communication activity.
  • Page 16 In normal system activity, the LEDs operation will occur as In normal system activity, the LEDs operation will occur as described in table A.1 (LED Indication description): Should described in table A.1 (LED Indication description): Should you notice a different LED feedback, please refer to section you notice a different LED feedback, please refer to section 8: Troubleshooting. 8: Troubleshooting. How to transfer a patient connected to the TTP™ system? How to transfer a patient connected to the TTP™ system? In order to transfer a patient from one location to another: In order to transfer a patient from one location to another: 1. Disconnect the SCU from the extension cable. Make sure 1. Disconnect the SCU from the extension cable. Make sure the SCU is secured on the patient’s gown and that the the SCU is secured on the patient’s gown and that the SU remains in place, on the patient’s temple properly SU remains in place, on the patient’s temple properly connected to the SCU.
  • Page 17 How to remove the SU from the patient? How to remove the SU from the patient? When core body temperature monitoring is no longer When core body temperature monitoring is no longer required, take the following steps: required, take the following steps: 1. Disconnect the SCU from the SU. Then remove the SU 1.

  • Page 18: Troubleshooting - Errors

    8. Troubleshooting - Errors 8. Troubleshooting - Errors The TTP™ system is designed to display system related feedback The TTP™ system is designed to display system related feedback warnings through its LEDs array, please refer to table A.1. For warnings through its LEDs array, please refer to table A.1. For LED indications at normal functionality. LED indications at normal functionality. Power Power Connectivity Connectivity SU Led SU Led When an error occurs, the following indication warnings will appear: When an error occurs, the following indication warnings will appear:...
  • Page 19 Error Indication Error Indication Possible Cause Possible Cause Instructions Instructions SCU LED is SCU LED is The SU is The SU is 1. Ensure the SU is properly 1. Ensure the SU is properly blinking blinking not properly not properly connected to the SCU. connected to the SCU. connected connected 2. If SCU LED is still blinking, 2.

  • Page 20: Care And Maintenance

    9. Care and Maintenance 9. Care and Maintenance CAUTION: CAUTION: • • Do not expose the TTP™ system to extreme temperatures, Do not expose the TTP™ system to extreme temperatures, humidity, direct sunlight or shock. humidity, direct sunlight or shock. • • Keep the TTP™ system away from hot or boiling water and Keep the TTP™ system away from hot or boiling water and chemicals. chemicals. • • Do not spray cleaning solutions onto any of the TTP™...
  • Page 21 Disinfecting the SCU Disinfecting the SCU Clean the SCU between each use. Clean the SCU between each use. Wipe down the SCU using a damp soft fabric and 70% Wipe down the SCU using a damp soft fabric and 70% isopropyl alcohol. Avoid spillover of fluids into the system’s isopropyl alcohol. Avoid spillover of fluids into the system’s parts.
  • Page 22 10. Specifications 10. Specifications Sensor Unit Sensor Unit Type\model number Type\model number Temple Touch Pro™ (TTP™) Temple Touch Pro™ (TTP™) Major components Major components Sensor Unit, Sensor Connecting unit, Sensor Unit, Sensor Connecting unit, Monitor Connecting Unit Monitor Connecting Unit Dimensions: WXLXH Dimensions: WXLXH (1.8X6.4X0.42)cm (1.8X6.4X0.42)cm Weight Weight 1.08g 1.08g Shelf Life Shelf Life 2 years 2 years Adhesive layer...
  • Page 23 Sensor Connecting Unit Sensor Connecting Unit Monitor Connecting Unit Monitor Connecting Unit Temple Touch Pro™ (TTP™) Temple Touch Pro™ (TTP™) Temple Touch Pro™ (TTP™) Temple Touch Pro™ (TTP™) Sensor Unit, Sensor Connecting unit, Sensor Unit, Sensor Connecting unit, Sensor Unit, Sensor Connecting unit, Sensor Unit, Sensor Connecting unit, Monitor Connecting Unit Monitor Connecting Unit Monitor Connecting Unit Monitor Connecting Unit (1.8X3.85X0.72)cm (1.8X3.85X0.72)cm (10.93X4.24X2.14)cm (10.93X4.24X2.14)cm 7.5g 7.5g 44.4g 44.4g 3 years 3 years 3 years 3 years 40cm...
  • Page 24 Sensor Unit Sensor Unit External power supply External power supply 90-260 VAC, 47~63Hz. Output 5V 90-260 VAC, 47~63Hz. Output 5V DC 36W. The unit shall be used DC 36W. The unit shall be used with dedicated medical grade AC/ with dedicated medical grade AC/ DC adapter. The system shall be DC adapter. The system shall be classified as Class II when used with classified as Class II when used with Mean Well’s GSM36U05-1PJ.
  • Page 25 Sensor Connecting Unit Sensor Connecting Unit Monitor Connecting Unit Monitor Connecting Unit 90-260 VAC, 47~63Hz. Output 5V 90-260 VAC, 47~63Hz. Output 5V 90-260 VAC, 47~63Hz. Output 5V 90-260 VAC, 47~63Hz. Output 5V DC 36W. The unit shall be used DC 36W. The unit shall be used DC 36W. The unit shall be used DC 36W. The unit shall be used with dedicated medical grade AC/ with dedicated medical grade AC/ with dedicated medical grade AC/ with dedicated medical grade AC/ DC adapter.

  • Page 26: Service And Warranty

    Class II device. as a Class II device. 11. Service and Warranty 11. Service and Warranty Distributed by: Distributed by: DeRoyal Industries, Inc. DeRoyal Industries, Inc. 200 DeBusk Ln. 200 DeBusk Ln. Powell, TN 37849 Powell, TN 37849 888.938.7828...
  • Page 27 The FCC wants you to Know The FCC wants you to Know This equipment has been tested and found to comply with This equipment has been tested and found to comply with the limits for a Class B digital device, according to Part the limits for a Class B digital device, according to Part 15 of the FCC Rules. These limits are designed to provide 15 of the FCC Rules. These limits are designed to provide...
  • Page 28 FCC ID: 2AK7V Product code: TTP-RFU-001 Distributed by: DeRoyal Industries, Inc. • This device complies with Part 15 of the FCC Rules. • is subject to the following two • This device may not cause harmful interference, and this device must accept any interference received, including interference that may cause undesired •...