TCM5 Instructions for Use for Lay Operators from sw ver 1.2 Dec 2017

Contents 1.

Introduction Intended use for lay operators...1 Home installation...1 Intended operators... 1 Training requirements for lay operators...2 Battery power... 2 Wireless communications equipment ... 2 Explanation of parameters... 2 Explanation of IP classification (IP32) ... 3 Consumables... 3 Important information... 3

2.

What is what? Front view... 5 Side view... 6 Rear view... 7 Main screen... 8 Explanation of symbols ...8 Explanation of graphical symbols on the screen...12

3.

Safety information About hazards... 15 General warnings... 15

4.

Using the monitor Setting up the monitor at home... 17 Night mode... 17 To activate Night mode... 17 Beginning a measurement... 17 Start of measurement... 17 Ear clips and fixation rings... 17

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Contents

TCM5: Instructions for use for lay operators

To attach a sensor with an ear clip... 18 To attach the sensor to a fixation ring... 21 Interrupting a measurement... 24 To interrupt a measurement... 24 Finishing the measurement...24 End of measurement... 24 To detach the sensor and the ear clip...25 To detach the sensor and the fixation ring... 27

5.

Troubleshooting Alarms... 29 What to do if an alarm activates... 29 Alarm messages... 29

6.

Legal information Legal notice... 31 Patents and trademarks... 31 Patents...31 Trademarks...31 Legal notices... 31 System performance... 31 No implied license... 31 Warranties and disclaimer... 32 Third party software and trademarks ... 32 Confidentiality... 32 Changes... 32 End-user license agreement MASIMO SET... 32 Compliance... 34

7.

Glossary Glossary... 35

Index

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Introduction

1

Intended use for lay operators 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)

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.

Home installation CAUTION – Risk of equipment damage Do not spill water on the monitor. Water can damage the monitor. In the event of water spillage, contact a Radiometer service representative. CAUTION – Risk that the patient is not being monitored Do not connect the monitor to unsecured or unprotected networks (e.g. direct connection to Internet). It is important that the TCM5 monitor is installed and put into service by a healthcare professional. Note: Assess the environment in which the TCM5 monitor is to be used. Avoid vacuum cleaning and other actions that generate dust. Avoid excessive ambient light (direct sunlight, strong light source) on the sensor as it might lead to incorrect SpO2 signals.

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.

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Chapter 1: Introduction

TCM5: Instructions for use for lay operators

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.

Battery power If there is an interruption or loss of the mains power supply, the TCM5 monitor automatically switches to battery operation. A fully charged battery lasts for max. 4 hours.

Wireless communications equipment Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base stations and walkie-talkies can affect this equipment and should be kept at a distance of 0.5 meters away from the equipment.

Explanation of parameters tcpCO2 CO2 is the chemical formula for carbon dioxide. "tc" stands for "transcutaneous". This means "through the skin". The "p" stands for "partial pressure" which means the tension or concentration of CO2 in the blood. Therefore, tcpCO2 is the partial pressure of carbon dioxide in the blood. SpO2 O2 is the chemical formula for oxygen. Oxygen is carried by the hemoglobin molecule in the blood. "S" stands for saturation. In this context the meaning of "S" is the percentage of oxygen bound to the hemoglobin in the red blood cells. "p" stands for pulse. In this context it means that only the pulsatile blood is measured.

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TCM5: Instructions for use for lay operators

Chapter 1: Introduction

PR PR is pulse rate.

Explanation of IP classification (IP32) The first digit indicates the level of protection against the ingress of solid parts and the access to hazardous parts. The enclosure of the TCM5 monitor provides protections against ingress of solid foreign objects >2.5 mm and against access to hazardous parts with e.g. tools or thick wires. The second digit indicates the level of protection that the enclosure provides against harmful ingress of water. The enclosure of the TCM5 monitor provides protections against ingress of dripping water when in normal position and when tilted up to 15°.

Consumables The consumables required to operate and maintain the TCM5 monitor and sensors are provided by your healthcare professional.

Important information Contact your healthcare professional for more information about the TCM5 monitor or measuring procedures. The contact information for your healthcare professional can be found on the last page of this Instructions for use.

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Chapter 1: Introduction

4

TCM5: Instructions for use for lay operators

2

What is what? 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

5

TCM5: Instructions for use for lay operators

Chapter 2: What is what?

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

TCM5: Instructions for use for lay operators

Chapter 2: What is what?

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

7

TCM5: Instructions for use for lay operators

Chapter 2: What is what?

Main screen

1

Icon bar area

2

Remaining site time

3

Parameters area (6 parameters)

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

Explanation Indicates that the product complies with the requirements of the Medical Device Directive 93/42/EEC. Indicates that the product complies with the requirements of the Medical Device Directive 93/42/EEC. Manufacturer

Date of manufacture

Patents: www.radiometer.com/en/ legal/patents www.masimo.compatents.htm

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Patents

TCM5: Instructions for use for lay operators

Symbol/Text

Chapter 2: What is what?

Explanation Lot no.

Catalog no. (product code)

Serial no.

Storage and transport temperature range for the monitor

Operation temperature range for the monitor

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 Follow instructions for use

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Chapter 2: What is what?

Symbol/Text

TCM5: Instructions for use for lay operators

Explanation This symbol indicates that Radiometer Basel AG 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. Marks compliance with SJ/T 11363-2006 (China RoHS). The number in the symbol shows the environmentally friendly use period in years. Marks compliance with SJ/T 11363-2006 (China RoHS). The product contains no restricted substances above the prescribed thresholds. US FDA Prescription Device Caution: Federal law restricts this device to sale by or on the order of a physician.

IP 32

IP Code: Degree of protection against harmful ingress of solids and water Fuse Battery Standby button

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TCM5: Instructions for use for lay operators

Symbol/Text

Chapter 2: What is what?

Explanation Class II device (IEC 60601-1)

Serial port (RS232) SENSOR

Sensor connector Nurse call

Graphical recorder (Analog output)

USB Ethernet connector

Degree of protection against electrical shock: Defibrillation-proof Type BF applied part Alternating current (AC)

Single use - do not reuse

Compressed Gas Non-flammable Gas

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Chapter 2: What is what?

TCM5: Instructions for use for lay operators

Explanation of graphical symbols on the screen These are the symbols you might see on the TCM5 monitor's screen. Symbol

Explanation Home care mode – locked

Audio off

Audio paused

Alarm off button

SmartHeat on

Atmospheric pressure is set manually or the Severinghaus correction is disabled LAN cable connected

LAN cable disconnected

LAN alert

Gas bottle status 0–100 %

Only the mains power supply is in use

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TCM5: Instructions for use for lay operators

Symbol

Chapter 2: What is what?

Explanation Battery charge 75-100 %

Battery charge 50–74 %

Battery charge 25–49 %

Battery charge 5–24 %

Battery charge 0–4 %

No battery installed

Remaining membrane lifetime 0-23 hours

Event

Multiple events

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Chapter 2: What is what?

14

TCM5: Instructions for use for lay operators

Safety information

3

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

General warnings 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 measurements Make sure the sensor is applied correctly. Incorrect application of the sensor can cause incorrect measurements. WARNING – Risk of electrical shock Do not use the monitor if it is damaged as this may result in electrical shock. WARNING – Risk of skin damage If you feel the sensor is too hot, remove it from the skin. WARNING – Risk of injury Keep children and pets away from the monitor as this can lead to injury. WARNING – Risk of skin damage Do not apply pressure on the sensor for prolonged periods as this might lead to burns or pressure injuries. CAUTION – Risk of equipment damage Do not spill water on the monitor. Water can damage the monitor. In the event of water spillage, contact a Radiometer service representative. WARNING – Risk of personal injury Do not touch the monitor rear connectors while third-party equipment is connected. Note: Monitoring a pregnant woman is limited to a maximum and accumulated period of 24 hours per pregnancy period.

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Chapter 3: Safety information

16

TCM5: Instructions for use for lay operators

Using the monitor

4

Setting up the monitor at home When placed in your home, the TCM5 monitor is switched on by your healthcare professional. Your healthcare professional will adjust the monitor settings to your needs and lock the monitor. You cannot adjust the settings. Only your healthcare professional can unlock the TCM5 monitor. WARNING – Risk of no measurements or incorrect measurements The TCM5 monitor should be installed by your healthcare professional only. Do not remove any connectors from the monitor. Do not modify the TCM5 monitor.

Night mode Night Mode is a mode that decreases the brightness of the screen. This makes sure that the light from the screen does not disturb you during the night.

To activate Night mode 1. Facing the front of the monitor, find the Standby button on the left side of the monitor. 2. Press the Standby button to activate the Night mode screen. 3. Tap the Night mode button on the screen.

Beginning a measurement Start of measurement The measurement starts when the sensor is removed from the calibration chamber.

Ear clips and fixation rings Your healthcare professional will attach the ear clip or fixation ring that is used with the sensor.

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