TCM5 Instructions for Use for Professionals from sw ver 1.2 Jan 2018

Contents 1.

Introduction Intended use... 1 Intended operators... 2 Environment of use...2 Training requirements for healthcare professionals... 2 Training requirements for lay operators...2 First-time setup...2 About hazards...3 Physiological limitations...3 Limitations of use... 4 Electromagnetic interference... 5 To reduce or remove electromagnetic interference ...5

2.

Getting to know your monitor Front view... 7 Side view... 8 Rear view ... 9 Bottom view...10 Main screen – FLEX configuration... 10 Main screen - BASIC configuration...11 Difference between BASIC and FLEX configurations... 11 Menu structure... 13 Explanation of symbols ... 14 Explanation of graphical symbols on the screen...18 Explanation of battery indicator... 21 Use modes...21 Use modes and sensor compatibility ... 21 To select a Use mode...22 Tutorials... 22 To start a tutorial... 23

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TCM5: Instructions for use for professionals

Patient monitoring Before monitoring...25 Start of measurement... 25 Preparing to monitor a patient... 25 To turn on the monitor...26 To start a measurement...27 Session... 27 Patient information...27 To enter patient information... 27 Sensor temperature and application time... 27 SmartHeat... 28 To set the sensor temperature... 28 Site timer... 28 To set the site time... 29 Moving the sensor from one ear to the other... 29 Alarm system versus use mode...29 Alarm limits... 29 To turn on the parameter alarms...30 To turn off the parameter alarms...30 To set the upper and lower alarm limits...30 To turn on audio pause ... 31 To set the upper and lower graph scales...31 To set the graph display time...31 To connect a sensor to the monitor...31 Calibration... 31 To calibrate the sensor...32 Stabilization... 32 Standby ...32 Automatic Standby ...33 To enter Standby manually...33 To exit Standby... 33 To activate Automatic Standby ...33 To deactivate Automatic Standby... 33 Measuring sites and use modes...34 Alternative sites for Sensor 92 only... 35 To see the membrane status...35 To attach a sensor with an ear clip... 35 To attach a sensor with a fixation ring...39 To attach a sensor with an adhesive ring... 42

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During monitoring... 45 Alarms... 45 Silencing alarms... 46 To audio pause the complete alarm system for 2 minutes... 47 To silence the active alarm... 47 Events...47 List of events... 47 To create a new event... 47 To view an event...47 After monitoring...47 End of measurement... 47 Removal of a sensor after the site time has expired... 48 To stop the measurement...48 To change the application site...48 To detach the sensor from the ear clip... 49 To detach the sensor and the fixation ring... 51 To detach the sensor and adhesive ring...52 Exporting records...54 To select an export format...54 To export a patient record... 55 To delete a patient record... 55 To shut down the monitor... 55

4.

Home use Home installation... 57 To turn on the monitor...57 To see the status of consumables... 57 To lock the screen in home care mode... 58 Briefing instructions... 58 Environmental conditions... 58

5.

Maintenance and troubleshooting Maintenance... 61 Decontamination...61 Calibration gas... 61 To change the gas bottle... 61 To see the gas status...62 Routine maintenance of sensor... 62 To maintain the sensor... 63

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TCM5: Instructions for use for professionals

To do a tcpO2 and tcpCO2 function test of a sensor... 63 To do an SpO2/PR function test of a sensor ...63 Remembraning the sensor...63 To remembrane the sensor...64 To set the remembraning frequency... 67 To clean and disinfect the sensor...68 Routine maintenance of the monitor... 70 Monitor self-test... 70 To perform a monitor self-test... 70 Alarm test...70 Barometric air pressure test... 70 To check the barometric air pressure ... 70 Check for damages... 71 Safety check... 71 Cleaning and disinfection of outer surfaces... 71 To clean and disinfect the calibration chamber... 72 To clean and disinfect the outer surfaces of the monitor... 74 Cleaning the touch screen... 76 To replace a fuse...76 To install the battery... 76 Battery replacement...76 To check the battery charge status ... 77 To check the battery life status ... 77 Routine maintenance of consumables... 77 Disposal of sensor and consumables... 77 To see the status of consumables... 77 Storage... 78 Troubleshooting...78 Messages...78

6.

Setup Operating requirements... 85 Ventilation requirements... 85 Operating conditions... 85 Electromagnetic interference... 86 To reduce or remove electromagnetic interference ... 87 To set up the monitor... 87 Adapter plate... 88 To connect a sensor to the monitor...88 Passwords...88

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To change the password...88 To change from FLEX to BASIC configuration... 88 To change from BASIC to FLEX configuration... 89 Use mode – default settings... 89 To select the time to activate automatic night mode... 92 To set the alarm volume... 92 Alarm audio pressure... 93 Connectivity to polysomnography and patient monitoring systems... 93 To connect to a polysomnography system ...93 MonLink...95 To connect using MonLink... 95 Connection to a Philips patient monitor... 96 To connect to a Philips monitor... 98 Network connectivity... 98 To automatically connect to an Ethernet network...99 To manually connect to an Ethernet network... 100 Monitor settings... 101 To set the language... 101 To set the date...101 To set the time... 101 To select a color for a parameter... 101 To select metabolic correction settings... 101 To set the averaging time of the SpO2 measurement and the pulse rate...102 To set the plethysmograph duration of the SpO2 measurement... 102 To set the sensitivity of the SpO2 measurement...102 To turn on the Pulse audio of the SpO2 measurement... 102 To set the sensor heating power... 102 To set the barometric pressure...103 To deactivate the Severinghaus correction... 103

7.

Specifications Specifications... 105 Known sources of interference... 115 EMC approvals and compliance ... 116

8.

Ordering information Ordering information... 121

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TCM5: Instructions for use for professionals

Legal information Legal notice...125 Patents and trademarks...125 Patents... 125 Trademarks... 125 Legal notices...125 System performance... 125 No implied license... 125 Warranties and disclaimer... 126 Third party software and trademarks ... 126 Confidentiality... 126 Changes... 126 End-user license agreement MASIMO SET...126 Compliance... 128

10.

Functional description Transcutaneous sensors... 129 Sensor memory... 129 Easy remembraning...129 tc Sensor 92...129 tc Sensor 84...130 tc Sensor 54...130 pCO2 measurement... 130 pO2 measurement... 131 Heating power... 131 SpO2 and pulse rate... 131 Pulse rate... 132 FastSat... 133 Sensitivity...133 Signal IQ... 133 Low perfusion (PI)...134 Oxygen saturation vs oxyhemoglobin fraction... 134

11.

Glossary Glossary... 135

Index

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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 pediatrics (>3 kg) or adults. On other conventional measuring sites only tcpCO2 can be monitored in pediatrics or adults. 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 neonates, pediatrics or adults. Additional application sites for pediatrics and adults 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 pediatrics or adults. On other conventional measuring sites tcpCO2 can be monitored in neonates, pediatrics or adults.

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 pediatrics (>3 kg) or adults. On other conventional measuring sites only tcpCO2 can be recorded in pediatrics or adults.

The TCM5 monitoring system is indicated for use in hospitals, in hospital-like facilities, in home environments and for use during intra-hospital patient transport and patient transport in road ambulances. The TCM5 monitoring system is intended for use by healthcare professionals and by trained lay operators (in a passwordprotected monitor mode with limited functionality only). When used by lay operators, i.e. by people without medical education, the TCM5 monitor, including the tc Sensors and accessories is intended for non-invasive continuous transcutaneous (through the skin) recording of: • • •

carbon dioxide partial pressure (tcpCO2) functional oxygen saturation (SpO2) pulse rate (PR)

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using the tc Sensor 54 (with FLEX configuration only) and tc Sensor 92 applied on the earlobe, the cheek or the forehead of children (>3 kg), adolescents or adults. On other measuring sites only tcpCO2 can be recorded. The TCM5 monitoring system is for prescription use only.

Intended operators The TCM5 monitor is intended for use by healthcare professionals and by trained lay operators who have been instructed in the use and care of the monitor by healthcare professionals. Healthcare professionals and lay operators must be over 18 years of age.

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

Training requirements for lay operators Lay operators must have received hands-on training by a healthcare professional in the procedures and functions that are relevant for the use of the TCM5 monitor at home and that are described in chapter 4 of the Instructions for use for professionals. Lay operators must have been trained in the procedures and functions until they can perform them successfully. A Short-form instruction document for sensor application will be supplied to the lay operator by the healthcare professional. Note: A checklist, to assist the healthcare professional when training the lay operator, is included in chapter 4 of this Instructions for use for professionals.

First-time setup When setting up the monitor for the first time, see Chapter 6, Setup.

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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 There is, according to current knowledge*, limited or no correlation between transcutaneous and arterial blood gas tensions under the following clinical situations: • Profound peripheral vasoconstriction • Comprised peripheral circulation • Circulatory centralization (shock) • Arterial occlusive diseases • Arteriovenous shunts (e.g. Ductus arteriosus) • Edema of the skin (e.g. edema neonatorum) and other skin anomalies • Hypothermia during surgery • Use of vasoactive drugs Like the transcutaneous technique, pulseoximetry 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, severe anemia, hypothermia or generally at low local tissue perfusion. 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. Furthermore, the pulse oxymetric 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

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• • •

•

• •

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

* Eberhard P. The design, use, and results of transcutaneous carbon dioxide analysis: current and future directions. Anesth Analg 2007;105 (6 Suppl):S48-S52.

Limitations of use 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 skin damage 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. Note: Monitoring a pregnant woman is limited to a maximum and accumulated period of 24 hours per pregnancy period.

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Electromagnetic interference WARNING – Risk of interference Instruments sensitive to electromagnetic interference may be affected by TCM5 measurements. A list of devices that may be affected by interference from the TCM5 monitoring system can be seen in the table below. If the below-mentioned options in To reduce or remove electromagnetic interference are not possible, do not use both the TCM5 monitoring system and such sensitive instruments simultaneously on the same patient. Abbreviation

Device

ECG

Electrocardiography

EEG

Electroencephalography

EMG

Electromyogram

MMG

Mechanomyogram

EOG

Electrooculography

GSR

Galvanic Skin Response

MEG

Magnetoencephalogram

ICG

Impedance Cardiography

Note: Some instruments offer means against electromagnetic interference. Please refer to the manufacturer and/or manufacturer's documentation.

To reduce or remove electromagnetic interference 1. Choose one of the options listed in order of priority below: Option

Description

1.

Connect the TCM5 monitoring system to a grounded Ethernet network using a shielded Ethernet cable. Please contact your Radiometer representative if this option is selected. Radiometer will assist in verifying that your Ethernet network is indeed grounded and in selecting types of Ethernet cables verified by Radiometer.

2. If a grounded Ethernet network is not available, option 2 may be selected.

Disconnect the TCM5 monitoring system from the mains supply and run it on battery power only. You can use the monitor for up to 4 hours with a fully charged battery.

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Option

Description

3. If you need to measure continuously for more than 4 hours, option 3 may be selected.

If an alternative monitoring system is available, consider using that one while waiting for the final solution from Radiometer. Your Radiometer representative may make a TC loaner device available.

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Getting to know your monitor

2

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

8

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

6

USB ports

2

Analog output

7

Ethernet port

3

USB device connector

8

Sensor connector

4

Serial port (RS232)

9

Mains power socket

5

Handgrip

10

Mains power fuses

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Bottom view 1

1

Retractable stand

2

Threaded inserts

2

3

3

Battery cover

Main screen – FLEX configuration

10

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 Home care mode Site time/temperature management Tutorials Interactive remembraning guide Event marker

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Function

FLEX

BASIC

Standby mode 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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