TCM5 Instructions for Use from sw ver 1.3 March 2020

Contents 1.

Introduction Intended use... 1 Intended operators... 1 Intended medical indications... 2 Environment of use...2 Training requirements for healthcare professionals... 2 First-time setup...2 About hazards...2 Physiological limitations...2 Limitations of use... 4

2.

Getting to know your monitor Front view... 5 Side view... 6 Rear view ... 7 Bottom view... 8 Main screen – FLEX configuration...8 Main screen - BASIC configuration... 9 Difference between BASIC and FLEX configurations... 9 Menu structure... 11 Explanation of symbols ... 12 Explanation of graphical symbols on the screen...16 Explanation of battery indicator... 18 Use modes...19 Use modes and sensor compatibility ... 19 To select a Use mode...20 Tutorials... 20 To start a tutorial... 20

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TCM5: Instructions for use

Patient monitoring Before monitoring... 21 Start of measurement... 21 Preparing to monitor a patient... 21 To turn on the monitor...22 To start a measurement...23 Session... 23 Patient information...23 To enter patient information... 23 Sensor temperature and application time... 23 SmartHeat... 24 To set the sensor temperature... 24 Site timer... 24 Moving the sensor from one ear to the other... 24 To set the site time... 25 Alarm system versus use mode...25 Alarm limits... 25 To turn on the parameter alarms...26 To turn off the parameter alarms...26 To set the upper and lower alarm limits...26 To turn on audio pause ... 27 To set the upper and lower graph scales...27 To set the graph display time...27 To connect a sensor to the monitor...27 Calibration... 27 To calibrate the sensor...28 Stabilization... 28 Standby ...28 Automatic Standby ...29 To enter Standby manually...29 To exit Standby... 29 To activate Automatic Standby ...29 To deactivate Automatic Standby... 29 Measuring sites and use modes...30 Alternative sites for Sensor 92 only... 31 To see the membrane status...31 To attach a sensor with an ear clip... 31 To attach a sensor with a fixation ring...35 To attach a sensor with an adhesive ring... 38

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During monitoring... 41 Alarms... 41 Silencing alarms... 42 To audio pause the complete alarm system for 2 minutes... 43 To silence the active alarm... 43 Events...43 List of events... 43 To create a new event... 43 To view an event...43 After monitoring...43 End of measurement... 43 Removal of a sensor after the site time has expired... 44 To stop the measurement...44 To change the application site...44 To detach the sensor from the ear clip... 45 To detach the sensor and the fixation ring... 47 To detach the sensor and adhesive ring...48 Exporting records...50 To select an export format...50 To export a patient record... 51 To delete a patient record... 51 To shut down the monitor... 51

4.

Maintenance and troubleshooting Maintenance... 53 Decontamination...53 Calibration gas... 53 To change the gas bottle... 54 To see the gas status...54 Routine maintenance of sensor... 54 To maintain the sensor... 55 To do a tcpO2 and tcpCO2 function test of a sensor... 55 To do an SpO2/PR function test of a sensor ...55 Remembraning the sensor...55 To remembrane the sensor...56 To set the remembraning frequency... 59 To clean and disinfect the sensor...60 Routine maintenance of the monitor... 62 Monitor self-test... 62 To perform a monitor self-test... 62

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Alarm test...62 Barometric air pressure test... 62 To check the barometric air pressure ... 62 Check for damages... 63 Safety check... 63 Cleaning and disinfection of outer surfaces... 63 To clean and disinfect the calibration chamber... 64 To clean and disinfect the outer surfaces of the monitor... 66 Cleaning the touch screen... 68 To replace a fuse...68 To install the battery... 68 Battery replacement...68 To check the battery charge status ... 69 To check the battery life status ... 69 Routine maintenance of consumables... 69 Disposal of sensor and consumables... 69 To see the status of consumables... 69 Storage... 70 Troubleshooting...70 Messages...70

5.

Setup Operating requirements... 77 Ventilation requirements... 78 Operating conditions... 78 To set up the monitor... 79 Adapter plate... 79 To connect a sensor to the monitor...79 Passwords...79 To change the password...80 To change from FLEX to BASIC configuration... 80 To change from BASIC to FLEX configuration... 80 Use mode – default settings... 80 To select the time to activate automatic night mode... 83 To set the alarm volume... 84 Alarm audio pressure... 84 Connectivity to polysomnography and patient monitoring systems... 85 To connect to a polysomnography system ...85 MonLink...86 To connect using MonLink... 87

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Connection to a Philips patient monitor... 87 To connect to a Philips monitor... 90 Network connectivity... 90 To automatically connect to an Ethernet network...91 To manually connect to an Ethernet network...92 Monitor settings... 92 To set the language...92 To set the date... 93 To set the time... 93 To select a color for a parameter... 93 To select metabolic correction settings... 93 To set the averaging time of the SpO2 measurement and the pulse rate... 93 To set the plethysmograph duration of the SpO2 measurement...94 To set the sensitivity of the SpO2 measurement... 94 To turn on the Pulse audio of the SpO2 measurement...94 To set the sensor heating power...94 To set the barometric pressure... 94 To deactivate the Severinghaus correction... 95

6.

Specifications Specifications... 97 Known sources of interference... 109 EMC approvals and compliance ... 110

7.

Ordering information Ordering information... 115

8.

Functional description Transcutaneous sensors... 119 Sensor memory... 119 Easy remembraning...119 tc Sensor 92...119 tc Sensor 84...120 tc Sensor 54...120 pCO2 measurement... 120 pO2 measurement... 121 Heating power... 121 SpO2 and pulse rate... 121

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Pulse rate... 122 FastSat... 123 Sensitivity...123 Signal IQ... 123 Low perfusion (PI)...124 Oxygen saturation vs oxyhemoglobin fraction... 124

9.

Glossary Glossary... 125

10.

Legal information Legal notice...129 Patents and trademarks...129 Patents... 129 Trademarks... 129 Legal notices...129 System performance... 129 No implied license... 129 Warranties and disclaimer... 130 Third party software and trademarks ... 130 Confidentiality... 130 Changes... 130 End-user license agreement MASIMO SET...130 End-user license agreement with Microsoft... 132 Compliance... 133 Report to manufacturer...133

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Introduction Intended use

The TCM5 monitoring system including the TCM5 monitor, tc Sensors and accessories is intended for non-invasive continuous transcutaneous monitoring of: •

•

•

carbon dioxide partial pressure (tcpCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using the tc Sensor 92 applied on the earlobe, the cheek or the forehead of pediatric (>3 kg) or adult patients. On other conventional measuring sites (chest, abdomen, back, upper arm, thigh, forearm, laterally on the neck, subclavicular) only tcpCO2 can be monitored in pediatric or adult patients. carbon dioxide partial pressure (tcpCO2) and oxygen partial pressure (tcpO2) using the tc Sensor 84 applied subclavicular, on the abdomen, upper arm, forearm, inner and outer thigh or back of neonate, pediatric or adult patients. Additional application sites for pediatric and adult patients are chest, laterally on the neck and on the forehead. carbon dioxide partial pressure (tcpCO2) using the tc Sensor 54 applied on the earlobe, cheek, forehead of pediatric or adult patients. On other conventional measuring sites tcpCO2 can be monitored in neonate, pediatric or adult patients.

The TCM5 monitor software provides 2 preconfigured parameter sets called FLEX (full functionality) and BASIC (limited functionality). If the BASIC parameter set is selected, the intended use is limited to non-invasive continuous transcutaneous recording of: •

carbon dioxide partial pressure (tcpCO2), functional oxygen saturation (SpO2) and pulse rate (PR), using the tc Sensor 92 applied on the earlobe, the cheek or the forehead of pediatric (>3 kg) or adult patients. On other conventional measuring sites (chest, abdomen, back, upper arm, thigh, forearm, laterally on the neck, subclavicular) only tcpCO2 can be recorded in pediatric or adult patients.

The TCM5 monitoring system is indicated for use in hospitals, in hospital-like facilities and for use during intra-hospital patient transport. The TCM5 monitoring system is intended for use by healthcare professionals only. The TCM5 monitoring system is for prescription use only.

Intended operators The TCM5 monitor is intended for use by healthcare professionals over 18 years of age.

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Chapter 1: Introduction

Intended medical indications Medical conditions where the healthcare professional finds it clinically relevant to use non-invasive and continuous transcutaneous monitoring of carbon dioxide partial pressure (tcpCO2), oxygen partial pressure (tcpO2) functional oxygen saturation (SpO2), and pulse rate.

Environment of use The TCM5 monitor is intended for use in these environments: • Hospital or clinic • Transport within a clinical environment

Training requirements for healthcare professionals Healthcare professionals must have received hands-on training in the procedures and functions that are relevant for their field of work and that are described in this Instructions for use.

First-time setup When setting up the monitor for the first time, see Chapter 5, Setup.

About hazards A hazard symbol shows which instructions an operator must obey to prevent risk to persons or equipment. There are 2 types of hazard. Hazard type

Hazard symbol

Risk

WARNING

Death or injury to persons

CAUTION

Equipment damage or monitoring disruption

Physiological limitations Under the following clinical situations there is, according to current knowledge1, limited or no correlation between transcutaneous and arterial blood gas tensions: • Profound peripheral vasoconstriction • Compromised peripheral circulation • Circulatory centralization (shock) • Arterial occlusive diseases • Arteriovenous shunts (e.g. persistent ductus arteriosus) • Edema of the skin (e.g. Edema neonatorum) and other skin anomalies

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• •

Chapter 1: Introduction

Hypothermia Use of vasoactive drugs

Like the transcutaneous technique, pulse oximetry relies on the existence of intact transport mechanisms of arterial blood to the measurement site. Whenever such transport is impaired to the extent that a sufficiently large pulse signal cannot be detected, SpO2 monitoring is no longer feasible. Such a condition may occur in cases of circulatory centralization (shock), peripheral vasoconstriction, venous congestion or generally at low local tissue perfusion. Furthermore, the pulse oxymetry measurement may not be valid under the following conditions: • Excessive ambient light • Severe electrical interference • Excessive patient movement • Significant levels of dysfunctional hemoglobin (e.g. COHb and metHb) • Presence of intra-vascular dye • Skin pigmentation • Very low hemoglobin level • Venous pulsation at the frequency of the patient's arterial pulse • Venous return when the sensor is applied onto the forehead or cheek when the head is lower than the heart (Trendelenburg position) • A pulse oximeter should NOT be used as an apnea monitor • Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG-based arrhythmia analysis. • Inaccurate measurements or loss of pulse signal may be caused by placement of a sensor on an extremity with a blood pressure cuff, arterial catheter or intravascular line • Loss of pulse signal can occur when the sensor is attached too tightly • Loss of pulse signal can occur when there is arterial occlusion proximal to the sensor Transcutaneous blood gas measurement should therefore not be regarded as a substitute for conventional arterial blood gas analysis. It is generally recommended that an accurate blood gas analysis be carried out prior to any decisive therapeutic measures. The use of the parameter(s) measured by the sensor cannot replace a permanent supervision of the patient by the medical personnel. Reference list: 1 JW. Severinghaus. The Current Status of Transcutaneous Blood Gas Analysis and Monitoring. Blood Gas News 1998. Vol. 7. No2: 4 – 9.

Sophie E. Huttmann, Wolfram Windisch and Jan H. Storre. Techniques for he Measurement and Monitoring of Carbon Dioxide in the Blood. Ann Am Thorac Soc Vol 11, No 4, pp 645-652, May 2014. Eberhard P. The design, use, and results of transcutaneous carbon dioxide analysis: current and future directions. Anesth Analg 2007;105 (6 Suppl):S48-S52.

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TCM5: Instructions for use

Chapter 1: Introduction

Emily L. Dobyns. Chapter 39 - Assessment and Monitoring of Respiratory Function in Pediatric Critical Care (Fourth Edition), 2011. Chan ED, Chan MM, Chan MM. Pulse oximetry: understanding its basic principles facilitates appreciation of its limitations. Respir Med. 2013 Jun;107(6):789-99.

Limitations of use Note: Diagnosis should not only rely on transcutaneous monitoring. It is intended as an aid in patient assessment. It must be used in conjunction with other clinical signs and symptoms. WARNING – Risk of infection and inaccurate results Reuse of single-use devices may lead to infection of patients and inaccurate results. WARNING – Risk of incorrect measurement Do not use the sensors during MRI scanning. Conducted current may cause burns. Also, the sensors may affect the MRI image, and the MRI unit may affect the accuracy of oximetry measurements. WARNING – Risk of skin damage Long-term hyperthermia may blister skin. When producing local hyperemia by means of hyperthermia, a certain risk of applying temperatures harmful to the skin is always present, although the risk is limited due to the control system of the monitor. Always pay attention to the use of hyperthermia for special patients, e.g. patients in shock, patients with low blood pressure, and patients with vascular constrictions. WARNING – Risk of incorrect measurement Do not measure SpO2 or PR under very low perfusion. WARNING – Risk of incorrect measurements Remove the sensors from the patient immediately if the system or patient is exposed to electrocautery or other high-frequency electrical signals, as these may affect the monitor and may cause injury to the patient. CAUTION – Risk that the patient is not being monitored Do not expose the monitor to heavy rain. Water can damage the monitor. In the event of exposure to heavy rain, contact a Radiometer service representative. Note: This equipment is not a blood gas device. It is recommended that, prior to any decisive therapeutic measures, an accurate arterial blood gas analysis is carried out. The use of the TCM5 monitoring system cannot replace a permanent supervision of the patient by medical personnel. Note: Monitoring a pregnant woman is limited to a maximum and accumulated period of 24 hours per pregnancy period.

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Getting to know your monitor

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Front view

1

Alarm bar

5

Battery indicator

2

Calibration chamber

6

Cable-wrap bar

3

Follow the Instructions for use

7

Speaker

4

Touch screen

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Side view 1 5 2 6

3

6

4

7

1

Alarm bar

5

Hand grip

2

Calibration chamber

6

Gas bottle

3

Standby button

7

USB port

4

Cable-wrap bar

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Rear view

1

Nurse call

7

Ethernet port

2

Analog output

8

Sensor connector

3

USB device connector

9

Potential equalization connector

4

Serial port (RS232)

10

Mains power socket

5

Handgrip

11

Mains power fuses

6

USB ports

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Chapter 2: Getting to know your monitor

Bottom view 1

1

Retractable stand

2

Threaded inserts

2

3

3

Battery cover

Main screen – FLEX configuration

8

1

Icon bar area

3

Parameters area

2

Touch keys area

4

Graphs area

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Main screen - BASIC configuration 1

3

2

1

Icon bar area

2

Touch keys area

3

Parameters area (6 fields)

Difference between BASIC and FLEX configurations The table shows which functions are available with the BASIC and FLEX configurations. Function

FLEX

BASIC

NICU mode Adult mode Sleep mode Site time/temperature management Tutorials Interactive remembraning guide Event marker Standby mode

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Function

FLEX

BASIC

Protocol for Philips IntelliBridge Detail view Trend graphs Parameter alarms Technical alarms tc Sensor 54 compatible tc Sensor 84 compatible tc Sensor 92 compatible

Note: The sensor compatibility also depends on the use modes. For more information See Use modes and sensor compatibility.

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Menu structure

Menu

Overview

Battery Gas Membrane Battery life Storage Start remembraning Confirm remembraning

Alarm & scale

tcpCO2 tcpO2 SpO2 PR PI Heating power

Records

Search Export Delete

Tutorial

Remembrane Attach ear clip Detach ear clip Disinfect sensor Attach fixation 20 Detach fixation 20 Disinfect monitor Attach fixation 32 Detach fixation 32 Clean chamber Attach adhesive Detach adhesive Change gas

Settings

Time & language & location Parameters Display & audio

Service

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Explanation of symbols These are the symbols and abbreviations you might see on the housing, packaging and on the accessories of the TCM5 monitoring system. Symbol/Text

Explanation CE marking of conformity

CE marking of conformity Medical Device

Manufacturer

Date of manufacture

Patents:

Patents

www.radiometer.com/en/legal/patents www.masimo.compatents.htm Lot no.

Catalog no. (product code)

Serial no.

Storage and transport temperature range for the monitor

Operation temperature range for the monitor

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Symbol/Text

Explanation Storage temperature range for sensor or accessories

Consult instructions for use

Use-by date

Warning, consult accompanying documents for important safety information Caution, consult accompanying documents for important safety information Refer to instruction manual/booklet

This symbol indicates that Radiometer Medical A/S and its distributors within the European Union (EU) and associated states have taken the necessary steps to comply with the "DIRECTIVE 2012/19/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 4 July 2012 on waste of electrical and electronic equipment (WEEE)". Equipment marked with this symbol must not be disposed of as household waste but as electronic waste in accordance with local legislation. Please note that equipment contaminated with potentially infectious substances, such as body fluids, must be decontaminated before recycling. If this is not possible, the equipment must be disposed of as biohazardous material. Contact your local Radiometer representative for instructions.

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