Smartsigns Compact SC300 Monitor Instructions for Use Edition 781301EN-3

Notice This document contains proprietary information that is protected by copyright. All Rights Reserved. Reproduction, adaptation, or translation without prior written permission is prohibited, except as allowed under the copyright laws.

Warranty The information contained in this document is subject to change without notice. Huntleigh Healthcare Ltd makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose. Huntleigh Healthcare Ltd shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.

Revision History The documentation part number and revision number indicate its current edition. The revision number changes when a new edition is printed in accordance with the revision history of the documentation. Minor corrections and updates which are incorporated at reprint do not cause the revision number to change. The document part number changes when extensive technical changes are incorporated.

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1. General Safety Information ...5 1.1 Warnings / Cautions ... 5

2. Introduction ...8 2.1 2.2 2.3

Features of the Smartsigns® Compact 300 ... 8 Intended Use... 9 About This Manual ... 9

3.1 3.2 3.3 3.4 3.5 3.6

Identification of Front Panel Controls and Symbols ... 10 Identification of rear panel controls ... 11 Identification of Side panel controls ... 11 Identification of Underside ... 12 Description of Symbols/ Indicators... 12 Description of Controls... 14

4.1 4.2 4.3 4.4

Unpacking and Inspection... 16 List of Components ... 16 Power Cable Connections ... 17 Connecting Accessories... 18

5.1 5.2 5.3 5.4

Installing the Battery pack ... 20 Operating on Battery Power... 21 Charging a low battery ... 21 Battery Using Guidance ... 21

7.1 7.2 7.3

Turning the Monitor ON ... 24 Performing Power On and Self-Test (POST) ... 25 Turning the Monitor OFF ... 25

8.1 8.2 8.3 8.4 8.5 8.6

Measuring Mode ... 26 Review Mode ... 26 Pulse Tone Setting ... 27 Standby Mode ... 27 Exiting Standby Mode ... 27 Maintenance Mode ... 28

9.1 9.2 9.3 9.4

General ... 32 Setup Connections... 32 Starting / Stopping Measurements... 34 Automatic Measurements ... 34

10.1 10.2 10.3 10.4

General Principles of Measuring SpO2 Plethysmography Parameter ... 37 Identifying the SpO2 Module ... 38 Setup Connections... 38 SpO2 and Pulse Rate Display ... 39

3. Description of Controls, Indicators,Symbols and Displays ...10

Table of Contents

Contents

4. Setting up the Monitor...15

5. Battery Operation ...20

6. System Display ...22 7. Using the Monitor ...24

8. System Settings ...26

9. NIBP Monitoring...31

10. SpO2/Pulse Rate Monitoring ...36

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Table of Contents

11. Temperature Monitoring ...40 11.1 11.2 11.3 11.4 11.5

Description of the Thermometer IRT10 ... 40 Thermometer Display... 41 Main Unit Display ... 41 Pairing the Thermometer and Main Unit ... 42 Temp Measurement ... 42

12.1 12.2 12.3 12.4 12.5 12.6

General ... 43 Returning the Smartsigns® Compact 300 and System Components ... 43 Service ... 43 Periodic Safety Checks ... 43 Cleaning ... 44 Battery maintenance ... 44

13.1 13.2 13.3

General ... 45 Corrective Action ... 48 Obtaining Technical Assistance ... 48

15.1 15.2 15.3 15.4 15.5 15.6

Equipment Classification ... 53 Standards... 53 General ... 53 Electrical ... 54 Environmental ... 54 Measurement Parameters ... 55

18.1

Service Returns ... 60

12. Maintenance ...43

13. Troubleshooting ...45

14. Electromagnetic Compatibility ...49 15. Specifications ...53

16. Accessories ...57 17. End of Life Disposal ...59 18. Warranty & Service ...60

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General Safety Information This section contains important safety information related to general use of the Smartsigns® Compact 300 vital signs monitor. Other important safety information appears throughout the manual Important! Before using this equipment, please study this manual carefully and familiarise yourself with the controls, display features and operating techniques. Ensure each user fully understands the safety and operation of the unit, as misuse may cause damage to the unit or injury to the user or patient.

1.1 Warnings / Cautions General warning / caution Refer to Instructions for Use

General Safety Information

1.

WARNING: In the USA, do not connect to an electrical outlet controlled by a wall switch as the device may be accidentally turned off. WARNING: If in doubt about the integrity of the AC power source, the monitor must be operated from its internal battery. WARNING: As with any medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: If the monitor does not shut down properly, the settings return to factory defaults. WARNING: Check the equipment prior to use and ensure its safe and proper use. WARNING: Do not autoclave the monitor. WARNING: Explosion hazard. Do not use the unit in the presence of flammable anaesthetics or gases. Do not operate in a hyperbaric chamber, in oxygen-enriched environments, or in any other potentially explosive environment. WARNING: Before use, carefully read the accessories instructions for use, including all warnings, cautions, and instructions. WARNING: Do not use damaged cuffs, sensors and other cables. Do not immerse cuffs, sensors and other cables completely in water, solvents, or cleaning solutions as the connectors are not waterproof. Do not sterilize cuffs, sensors and other cables by irradiation, steam, or ethylene oxide. Refer to each cleaning instructions in the directions for use.

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General Safety Information

WARNING: If the battery shows any signs of damage, leakage, or cracking, it must be replaced immediately, by a qualified service person, and only with a battery approved by the manufacturer. WARNING: The monitor is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. WARNING: The measurement of vital signs can be affected by patient conditions, motions, sensors, environmental condition and electromagnetic external condition. WARNING: It is possible that any radio frequency transmitting equipment and other sources of electrical noise such as cellular phones, due to close proximity or strength of a source, may result in disruption of performance. WARNING: To ensure patient safety, do not place the monitor in any position that might cause it to fall on the patient. WARNING: Disconnect the monitor and sensors during magnetic resonance imaging (MRI) scanning. Use during MRI could cause burns or adversely affect the MRI image or the monitor’s accuracy. Also, to avoid burns, remove the sensors from the patient before conducting MRI. WARNING: During prolonged and continuous SpO2 monitoring, check the sensor site at least once every 4 hours. Inspect the patient’s skin integrity and circulation, and relocate the sensor if necessary. Tissue damage can result from improper or prolonged sensor attachment. WARNING: Do not lift the monitor by a sensor cable or a power cord because the cable could disconnect from the monitor, causing the monitor to drop on the patient. WARNING: The unit may not operate effectively on patients who are experiencing convulsions or tremors. WARNING: Do not connect more than one patient to the monitor. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

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CAUTION: Exercise care for the safe and effective use of Smartsigns® Compact 300 monitor. Inaccurate data may be measured if operated or stored at conditions outside the stated ranges, or subjected to excessive shock or dropping. CAUTION: Grounding reliability can only be achieved when equipment is connected to an equivalent receptacle marked ‘Hospital Only’ or ‘Hospital Grade’. CAUTION: The accuracy of the monitor may degrade if the monitor is connected to secondary I/O devices when the monitor is not connected to earth reference. CAUTION: Never place fluids on the monitor. In case of fluid spilling on the monitor, disconnect power cord, wipe clean immediately and have the monitor serviced to ensure that no hazard exists.

CAUTION: Accessory equipment connected to the monitor’s data interface must be certified according to IEC60950 for data processing equipment or IEC60601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC60601-1-1 system requirements. Anyone who connects additional equipment to the signal input or signal output port configures a medical system and is therefore responsible that the system complies with the requirements of IEC60601-1-1 and the electromagnetic compatibility standard IEC606011-2. If in doubt, contact Huntleigh Healthcare Service Department.

General Safety Information

CAUTION: The monitor may display error codes when outside of the measurable range occur.

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Introduction

2.

Introduction WARNING: The Smartsigns® Compact 300 is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms. This manual contains information about the Smartsigns® Compact 300 vital signs monitor. The Smartsigns® Compact 300 is available in the following configurations: Features

Config. SC300

NiBP, Pulse & SpO2

SC300T

NiBP, Pulse, SpO2 & Temperature

SC300N

NiBP, Pulse & SpO2 (NELLCOR)

SC300NT

NiBP, Pulse, SpO2 (NELLCOR) & Temperature

Note: Refer to Specification Section for more information about each configuration. All information in this manual, including the illustrations, are based on a monitor configured with the NIBP, SpO2 and Temperature options. If your monitor configuration lacks any of these options, certain information in this manual does not apply.

2.1

Features of the Smartsigns® Compact 300 Physical The Smartsigns Compact 300 series is a small lightweight SPOT check vital signs monitor. It measures 130mm x 125mm x 219 mm and weighs 1.25 Kg. The integrated carry handle allows the unit to be hand carried between locations.

Electrical The monitor is powered either by the local mains supply (100 – 240 VAC 50/60Hz) or an internal 2200 mAh lithium Ion battery. The internal batteries are charged whenever the SC300 is connected to the local supply.

Display The monitor uses a 6” LED type of numerical display to display patient and system status.

Auxiliary Outputs The monitor provides an RS-232 I/O facility on the rear of the unit, this is used for software upgrades.

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Intended Use The Smartsigns Compact 300 Series is intended for use by trained healthcare professional in healthcare settings to monitor physiologic status of Adult, Paediatric and Neonatal patients. Physiologic measurements include: • • • •

2.3

Non invasive blood pressure (NiBP) Pulse oximetry Pulse rate Temperature

Note:

Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acutecenters.

Note:

Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.

Note:

The medically skilled and trained user can be clinicians like doctors and nurses who know how to take and interpret a patient’s vital signs. These clinicians must take direct responsibility for the patient’s life. This can include care-givers or medically trained interpreters who are authorised under the appropriate clinical facility procedures to support patient care. Any inappropriate setting, can lead to a hazardous situation that injures, harms or threatens the patient’s life. This equipment should only be operated by trained users who can adjust the settings of the monitor.

Introduction

2.2

About This Manual This manual explains how to set up and use the Smartsigns® Compact 300 vital signs monitor. Important safety information relating to general use of the monitor appears before this introduction. Other important safety information is located throughout the text where applicable. Read the entire manual including the Safety Information section, before you operate the monitor. This manual is compatible with units fitted with Version 3.0 software and above.

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Description of Controls, Indicators, Symbols and Displays 10

3.

Description of Controls, Indicators, Symbols and Displays

3.1

Identification of Front Panel Controls and Symbols

1 2

8

5

6

4

7

3

1

Carry handle

2

Display

3

ON / OFF Battery Indicator

4

• • •

ON: Battery is being charged, or fully charged OFF: Battery is not fitted or faulty FLASHING: The battery is supplying power to the monitor.

AC Power Indicator • ON: Monitor is connected to AC power • OFF: Monitor is not connected to AC power 5

Return

6

Patient group selection

7

Start / Stop NiBP

8

Wireless infrared thermometer

Identification of rear panel controls

1 5 3 2

1

Loudspeaker

2

Equipotential post

3

RS232 Service port

4

AC Power connector

5

Product identification label

4 3.3

Identification of Side panel controls Left

1

Right

2 1 2

1

NiBP connector

2

SpO2 connector

1

Wireless Infra red thermometer IRT10 (option)

2

Thermometer lens (option)

Description of Controls, Indicators, Symbols and Displays

3.2

11

Description of Controls, Indicators, Symbols and Displays

3.4

Identification of Underside

2 1

Battery compartment

2

Adaptor plate fixing point

The internal battery is accessed through the compartment located on the underside of the unit. A fixing kit is available for the unit. It is attached using a single point fixing.

3.5

Description of Symbols/ Indicators The symbols and Indicators are described as follows: Symbols

Description Attention, consult accompanying documents.

Patient type: Adult

Patient type: Paediatric

Patient type: Neonatal

Start / Stop Non-invasive blood pressure measurement

Type BF – Defibrillator proof

Equipotentiality

On/Off/Standby

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1

Description Battery charging indicator lamp

AC power(AC)

Input/output

Refer to instructions for use

IPX1

Protection against vertically falling water drops

SN

Serial number (Date of manufacture is included in SN) This symbol signifies that this product complies with the essential requirements of the Medical Devices Directive 93/42/EEC as amended by 2007/47/EC This symbol signifies that this product, including its accessories and consumables is subject to the WEEE (Waste Electrical and Electronic Equipment) regulations and should be disposed of responsibly in accordance with local procedures. Manufacturer

This way Up

Fragile – Handle with care

Limit of stacking layers

Keep dry

Description of Controls, Indicators, Symbols and Displays

Symbols

13

Description of Controls, Indicators, Symbols and Displays 14

3.6

Description of Controls

Description

Controls ON/OFF/STANDBY Key •

Press this button to start the system – the system status indicator will illuminate green. • When in measurement mode, press this button to enter standby mode – the system indicator changes to amber. • To switch OFF, press and hold this button for 2s. Return key Error code clearance • Press this key to clear any error code which may be displayed when in measurement mode. Save measurement • Press this key to save measurement to memory Memory re-call • Press and hold this key for 2s to access stored measurements in the memory Pulse tone enable / disable • Press and hold this key for 4s to enable the pulse tone setting (on / off) Maintenance mode selection • Press this key within 10s of power up to enter the maintenance mode. Patient Group select key Patient selection •

Press this key to select the relevant patient group.

Start/Stop NIBP Measurement •

Press this key to initiate a blood pressure measurement, If the button is pressed during a measurement, the measurement will stop.

Setting up the Monitor WARNING: The Smartsigns® Compact 300 is a prescription device and is to be operated by qualified personnel only. It is designed for use by medical clinicians. Although this document might illustrate medical monitoring techniques, the monitor must be used only by trained clinicians who know how to take and interpret a patient’s vital signs. WARNING: In the USA, do not connect to an electrical outlet controlled by a wall switch because the device may be accidentally turned off. WARNING: As with all medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: To ensure patient safety, do not place the monitor in any position that might cause it to fall on the patient. WARNING: Do not lift the monitor by the sensor cables or power cord because the cable could disconnect from the monitor, causing the monitor to drop on the patient.

Setting up the Monitor

4.

WARNING: Disconnect the monitor and sensors/cables during magnetic resonance imaging (MRI) scanning. Using the monitor during MRI may cause burns or adversely affect the MRI image or the monitor’s accuracy. WARNING: To ensure accurate performance or prevent device failure do not subject the monitor to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure WARNING: Do not use the Smartsigns® Compact 300 vital signs monitor, SpO2 sensors, temperature probes or connectors that appear damaged. WARNING: Discarded battery may explode during incineration. Follow local government ordinances and recycle instructions regarding disposal or recycling of device components, including batteries. WARNING: Do not touch the monitor when a defibrillator is being discharged (electrified), as doing so may cause electric shock. WARNING: Ensure that the speaker is clear of any obstruction. Failure to do so could result in an inaudible tone. CAUTION: If the Smartsigns® Compact 300 is to be stored for a period of 2 months or longer, it is recommended to notify service personnel to remove the battery from the monitor prior to storage. Recharging the battery is strongly recommended when the battery has not been recharged for 2 or more months. CAUTION: Recycle used batteries properly. Do not dispose of batteries in refuse containers.

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Setting up the Monitor

4.1

Unpacking and Inspection The Smartsigns® Compact 300 vital signs monitor is shipped in one carton. Examine the carton carefully for evidence of damage. Contact Huntleigh Healthcare Ltd Service Department immediately if any damage is discovered. Return all packing material and monitor. Refer to the Maintenance section for instructions on returning damaged items. Set the monitor to the user’s intended position where the user can easily recognise the visual and audible monitoring conditions.

4.2

List of Components Quantity

Item

1

Smartsigns Compact 300 Spot Check Vital Signs Monitor

1

NiBP Cuff Adult ( 25 – 35 cm)

1

NiBP hose

1

SpO2 sensor

1

Wireless thermometer (Optional)

1

Thermometer lens - pack 20 pcs (Optional)

1

Operator’s manual

1

Power cord (country specific)

1

Grounding wire

A range of accessories are available for the Smartsigns Compact 300 series, please contact your distributor or the customer services Department for more information.

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Power Cable Connections WARNING: In the USA, do not connect to an electrical outlet controlled by a wall switch because the device may be accidentally turned off. CAUTION: For the safety of patients, use only a Huntleigh Healthcare Ltd supplied power cord. Using a non approved power cord can damage the monitor, and will void the product warranty. If in doubt about the integrity of the AC power source, the monitor must be operated from its internal battery.

AC Power Ensure that the AC outlet is properly grounded and that it is in the specified voltage and frequent range (100 – 240 VAC, 50-60 Hz).

1 2

1. 2. 3. 4.

1

AC inlet

2

Equipotential point

Setting up the Monitor

4.3

Connect the female connector end of the AC power cord to the monitor rear panel connector. Plug the male connector end of the AC power cord into a suitably grounded AC outlet. Verify that the Charging/AC Indicator is lit. If necessary, connect the grounding wire. Connect the grounding wire connector to the equipotential terminal on the rear panel. Attach the clip end of the grounding wire to the medical equipment grounding terminal on the wall.

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Setting up the Monitor

4.4

Connecting Accessories WARNING: Do not lift the monitor by the sensor cables, or power cord because the cable could disconnect from the monitor, causing the monitor to drop on the patient. Note: For the safety of patients, and to ensure the best product performance and accuracy, use accessories provided with the Smartsigns® Compact 300 only, or accessories recommended by Huntleigh Healthcare Ltd Service Department.

NIBP Hoses and Cuffs NIBP Hose Connector

1.

Select the appropriate size cuff for the patient and apply the cuff to the selected site.

2.

Connect the hose to the NiBP connector on the side of the unit.

SpO2 Cables and Sensors SpO2 Interface cable connector

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1.

Select an appropriate sensor for the patient and desired application.

2.

Apply the sensor to the selected site.

3.

Connect the SpO2 sensor to the side of the unit.

Setting up the Monitor

Wireless thermometer (Option)

1 2

4

3 5

6

1

Status indicator

2

Start measurement

3

Display

4

Infra red sensor

5

Lens ejector

6

Battery compartment

19

Battery Operation

5.

Battery Operation WARNING: Dispose of Battery in accordance with local requirements and regulation. Follow local instructions regarding disposal or recycling of batteries. CAUTION: If the Smartsigns® Compact 300 is to be stored for a period of 2 months or longer, it is recommended to notify service personnel to remove the battery from the monitor prior to storage. Recharging the battery is strongly recommended when it has not been recharged for 2 or more months CAUTION: Measured or displayed data may not be assured in the low battery or the critical low battery condition. CAUTION: Discarded battery may explode during incineration. Recycle used batteries properly. Do not dispose of batteries in refuse containers. Note: As the battery is used and recharged over a period of time, the amount of time between the onset of the low battery alarm and the instrument shut-off may become shorter. It is recommended for service personnel to check periodically or replace of internal battery if necessary.

Note: It is recommended that the monitor remain connected to AC power source when not in use. This will ensure a fully charged battery whenever it is needed.

5.1

Installing the Battery pack The monitor has an internal Lithium Ion rechargeable battery which can power the unit when an AC power source is not available. Turn the monitor OFF, disconnect the power cord and any accessory. Place the monitor on a surface and place upright with the base exposed. Unscrew the battery cover, offer the battery into the battery compartment making sure the positive and negative terminals are connected correctly. Replace the battery cover and secure, turn the monitor upright.

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