Smartsigns Liteplus SL600 User Manual

USER MANUAL Smartsigns® Liteplus Vital Signs Monitor

Medical Devices Directive 93/42/EEC

Manufactured in the UK by Huntleigh Healthcare Ltd. As part of the ongoing development programme the company reserves the right to modify specifications and materials of the Smartsigns® range without notice. Huntleigh Healthcare Ltd - A Huntleigh Technology PLC company. Smartsigns®, Huntleigh and ‘H’ logo are registered trademarks of Huntleigh Technology PLC 2006. © Huntleigh Healthcare Ltd. 2006

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 1.2

Warnings ... 5 Cautions ... 7

2. Introduction ... 8 2.1 2.2 2.3

Features for the Smartsigns® Liteplus ... 8 Intended Use for SL600... 9 About This Manual ... 9

3. Description of Controls, Indicators, Symbols and ... Displays... 10 3.1 3.2 3.3 3.4

Identification of Front Panel Controls and Symbols ... 10 Identification of Rear Panel Components and Symbols ... 11 Description of Symbols/Indicators ... 12 Description of SL600 Controls... 15

Table of Contents

Table of Contents

4. Setting up the Monitor ... 17 4.1 4.2 4.3 4.4 4.5 4.6

Unpacking and Inspection... 18 List of Components ... 18 Power Cable Connections ... 19 Measurement Cable Connections ... 20 SpO2 Cables and Sensors ... 20 Temperature Probes ... 21

5. Battery Operation ... 22 5.1 5.2 5.3

Operating SL600 on Battery Power ... 22 Charging a Low Battery ... 23 Low Battery Indication ... 23

6. Using the Monitor ... 24 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9

Turning on the Monitor ... 24 Performing Power On and Self-Test (POST)... 25 Setting Date and Time ... 26 Setting Patient Type ... 28 Setting NIBP Units ... 29 Setting Temperature Units and Modes ... 30 Setting Pulse Tone Volume... 31 Setting Alarm Volume ... 32 Resetting to Factory Defaults ... 33

7. NIBP Monitoring ... 34 7.1 7.2 7.3 7.4

General ... 35 Setup Connections ... 36 NIBP Measurement Modes ... 37 Description of NIBP Operation ... 37

8. SpO2/Pulse Rate Monitoring ... 41 8.1 8.2 8.3 8.4

General ... 42 Setup Connections ... 43 Description of Pulse Rate Operation ... 44 Description of SpO2 Operation ... 44

9. Temperature Monitoring ... 46 9.1 9.2 9.3 9.4

General ... 47 Setup Connections ... 47 Temperature Measurement Modes ... 48 Description of Temperature Operation ... 48

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Table of Contents

10. Alarms and Limits ... 54 10.1 10.2 10.3

General ... 54 Setting Alarm Limits ... 55 Alarm Silence ... 61

11.Reviewing Patient Data ... 62 11.1 11.2 11.3 11.4

General ... 62 Displaying Stored Patient Data ... 63 Printing Stored Patient Data (Optional Printer Installed)... 64 Erasing Patient Data ... 64

12.Printing ... 65 12.1 12.2 12.3 12.4

General ... 65 Selecting Manual or Stream Printing type ... 65 Printing Patient Data (Manual Mode) ... 66 Print Out Configuration ... 67

13.RS-232 Interface ... 70 13.1 13.2 13.3

Overview ... 70 Cable Connection... 70 Nurse Call Interface... 71

14.Maintenance ... 72 14.1 14.2 14.3 14.4 14.5 14.6 14.7

General ... 72 Returning SL600 and System Components ... 72 Service ... 72 Periodic Safety Checks ... 72 Cleaning ... 73 Battery maintenance ... 73 Replacement of Printer Paper ... 74

15.Troubleshooting ... 75 15.1 15.2 15.3 15.4

General ... 75 Corrective Action ... 76 EMI (Electromagnetic Interference)... 77 Obtaining Technical Assistance ... 78

16.Factory Defaults ... 79 16.1 16.2

General ... 79 Parameter Ranges and Default Settings ... 79

17.Specifications ... 80 17.1 17.2 17.3 17.4 17.5 17.6

Physical ... 80 Electrical ... 80 Environmental ... 80 Measurement Parameters ... 81 Compliance ... 84 Manufacturer’s Declaration ... 86

18.Warranty & Service... 90

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General Safety Information This section contains important safety information related to general use of the Smartsigns® Liteplus 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

Warnings are identified by the WARNING symbol shown above and alert you to potential hazards. WARNING: In the USA, do not connect to an electrical outlet controlled by a wall switch as the device may be accidentally turned off.

General Safety Information

1.

WARNING: If in doubt about the integrity of the AC power source, the monitor must be operated from its internal battery. WARNING: Do not disconnect a power cord before the system shuts down as monitor settings may be lost. WARNING: As with any medical equipment, carefully route patient cabling to reduce the possibility of patient entanglement or strangulation. WARNING: The unit is not defibrillator proof. It may remain attached to the patient during defibrillation or while an electrosurgical unit is in use, but the readings may be inaccurate during use and shortly thereafter. 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 anesthetics or gases. Do not operate in a hyperbaric chamber, in oxygen-enriched environments, or in any other potentially explosive environment.

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General Safety Information

WARNING: Before use, carefully read sensor or probe directions 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. 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.

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Cautions

CAUTION: U.S. Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. CAUTION: Alert you to exercise care necessary for the safe and effective use of SL600 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.

General Safety Information

1.2

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

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Introduction

2.

Introduction WARNING: The Smartsigns® Liteplus 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 Liteplus vital signs monitor. The Smartsigns Liteplus is available in the following configurations:

Config.

Features

Config.

Features

N

Standard (NIBP + Pulse Rate)

NP

Standard + Printer

NS

Standard + SpO2

NSP

Standard + SpO2 + Printer

NT

Standard + Temperature

NTP

Standard + Temperature+ Printer

NST

Standard + SpO2 + Temperature

NSTP

Standard + SpO2 + Temperature + Printer

All information in this manual, including the illustrations, are based on a monitor configured with the NIBP, Temperature, SpO2, and Printer options. If your monitor configuration lacks any of these options, certain information in this manual does not apply.

2.1

Features of the Smartsigns® Liteplus

Physical The SL600 vital signs monitor is a lightweight and compact vital signs monitor measuring 130×180×278 (mm) (H×D×W) and weighing 2.7 kg. Its carrying handle is designed for instrument transport while battery-powered monitoring.

Electrical The SL600 is powered by an internal battery pack which provides 2 hours of monitoring from fully charged batteries (typical, performance is at 25 °C, with no printing and one NIBP measurement every 15 minutes). The batteries are continuously recharged when AC power (100-240 VAC, 5060 Hz) is connected to the monitor. Details are described in the Battery Operation section.

Display 8

The SL600 has an LED display which shows numeric patient information as well as alphanumeric status conditions and error codes.

SL600 monitor provides RS-232 I/O port for software upgrade or nurse call system. Refer to the RS-232 Interface section for additional information.

2.2

Intended Use for SL600

The purpose and function of the Huntleigh Healthcare SL600 vital signs monitor is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate for adult, pediatric and neonate patients and temperature for adult and pediatric patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics.

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. Hospitaltype 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.

2.3

Introduction

Auxiliary Outputs

About This Manual

This manual explains how to set up and use the SL600 vital signs monitor. Important safety information relating to general use of the SL600 appears before this introduction. Other important safety information is located throughout the text where applicable. All users should read this manual thoroughly. More experienced users of the SL600 will be able to go to the topics for the information they require. Read the entire manual including the Safety Information section, before you operate the monitor.

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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 28 27 26 25

1 2

24 23 22 21

3 4 5

20

6 7

19

8

9 10

11 12 13 14 15 16 17 18

1

Blood Pressure Unit Indicators

15

%SpO2 Display

2

Systolic Blood Pressure Display

16

Mode Button

3

Patient Type Indicators

17

Pulse Amplitude Indicator

4

Diastolic Blood Pressure Display

18

Alarm Silence Indicator

5

Pulse Rate Display

19

Up/Down Selection Button

6

MAP (Mean Arterial Pressure) Display

20

Alarm silence button

7

Print Setting Indicators

21

8

Print Button

22

9

Alarm Button

23

NIBP start/stop button Temperature Unit/Mode Indicators Temperature Display

10

Auto Indicator

24

Power Button

11

Auto Cycle Display

25

Battery Indicator

12

Auto Button

26

Charging/AC in Indicator

13

Pulse Tone/Alarm Volume Setting Indicators

27

Time Display

14

Review Button

28

Review Indicator

Figure 1. Front Panel Controls and Symbols

Identification of Rear Panel Components and Symbols

1

2 AC IN 100-240V~, 50/60 Hz 28-38VA

3

4

5

6

1

Handle

4

Equipotential (Ground)

2

Air Ventilator

5

Battery Cover (Replacement)

3

AC Power Connector

6

RS-232 Data Interface

Figure 2. Rear Panel Components and Symbols

Description of Controls, Indicators, Symbols and Displays

3.2

11

Description of Controls, Indicators, Symbols and Displays 12

3.3

Description of Symbols/ Indicators

The symbols and Indicators of SL600 are described as follows: Table 1. Display Symbols/Indicators Symbols

Description Attention, consult accompanying documents.

Type BF applied part

Type BF – Defibrillator proof

Equipotentiality

Data interface

Review Indicator is lit when the user select the Review button to see the patient history. Auto Indicator is on whenever NIBP automatic timed cycles are enabled.

Charging/AC in Indicator is on whenever AC power is present from the wall (even if the monitor is off and is not under battery charging). The Charging/AC in indicator flashes while the battery is charging, and then remains illuminated once the battery is maintained with a trickle charge.

Description Battery Indicator indicates the state of the battery. This indicator is on when the monitor uses battery power. This indicator will be flashing when the battery needs charging. It is not reset unless AC power cord has been plugged in for battery charging. Alarm Silence Indicator is on continuously whenever the unit is in Alarm Silence mode.

Temperature in degrees Fahrenheit is configured to display temperature in degrees Fahrenheit.

Temperature in degrees Celsius is configured to display temperature in degrees Celsius. Temperature in Monitor mode is configured to take temperature in the monitor mode. This indicator is off when the temperature is being taken using the predictive method. Patient type: Adult is on when the Patient type is adult. Patient type: Paediatric is on when the Patient type is paediatric. Patient type: Neonatal is on when the Patient type is neonatal. NIBP unit: mmHg is on when the NIBP unit setting is mmHg.

Description of Controls, Indicators, Symbols and Displays

Symbols

NIBP unit: kPa is on when the NIBP unit setting is kPa.

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Description of Controls, Indicators, Symbols and Displays 14

Symbols

Description Target Pressure Setting Indicator is flashing when the NIBP target inflation pressure is under the setting for NIBP measurement. Time Indicator is on when the actual time is displayed on the time/date numeric display area. It is flashing when it is selected to set the time in configuration mode. Date Indicator is on when the actual date is displayed on the time/date numeric display area. It is flashing when it is selected to set the date in configuration mode.

Manual Print Indicator is on when the print setting is set to Manual Print.

Stream Print Indicator is on when the print setting is set to Stream Print.

Pulse Tone Volume Setting indicator is flashing when the pulse tone volume setting is selected in setting mode.

Alarm Volume Setting Indicator is flashing when the alarm volume setting is selected in setting mode.

Network Indicator is flashing when the monitor is set to software upgrade mode.

Description of SL600 Controls Table 2. SL600 Controls

Controls

Description

Power Button turns SL600 monitor on or off when pressed for over 1 second.

NIBP start/stop button initiates NIBP measurement when pressed. If the NIBP start/stop button is pressed again during the measurement, it will cancel the current reading.

Alarm Silence Button allows you to silence a patient alarm temporarily and also is used to acknowledge (cancel) other non-patient alarms.

Up/Down Selection Buttons allows you to select items within a particular settable feature in several different modes. If the Up or Down selection button is pressed and held, the unit will scroll through the available selections as if the button is being pressed repeatedly while the button is held in.

Print Button (Option) sends the data to the printer and prints current onscreen readings if a printer is installed in the monitor. Pressing the Print button during print-out stops printing.

Description of Controls, Indicators, Symbols and Displays

3.4

15

Description of Controls, Indicators, Symbols and Displays 16

Controls

Description

Review Button allows the user to review or to erase measurement data in the memory. If pressed and held for more than 3 seconds, the monitor will erase the data.

Auto Button puts the monitor in Auto interval selection mode, allowing the user to take automatic blood pressures at a selected increment.

Alarm Button puts the monitor into Alarm Set mode, allowing the user to set alarm limits for Systolic, Diastolic, MAP, Pulse rate and SpO2.

Mode Button puts the monitor into the Settings or Configuration mode. Once the monitor is in one of these modes, the Mode button will be used to cycle through the configuration options of the specific menu mode.

Setting up the Monitor WARNING: The SL600 is a prescription device and is to be operated by qualified personnel only. The SL600 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 SL600 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 SL600 to extreme moisture, such as direct exposure to rain. Such exposure may cause inaccurate performance or device failure WARNING: Do not use SL600 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: SL600 is not defibrillator-proof. It may remain attached to the patient during defibrillation or while an electrosurgical unit is in use, but the readings may be inaccurate during the defibrillation and shortly thereafter. WARNING: Ensure that the speaker is clear of any obstruction. Failure to do so could result in an inaudible alarm tone. CAUTION: If SL600 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 SL600 vital signs monitor is shipped in one carton. Examine the carton carefully for evidence of damage. Contact Huntleigh Healthcare Ltd Technical Services Department immediately if any damage is discovered. Return all packing material and monitor. Refer to the Maintenance section for instructions on returning damaged items.

4.2

List of Components

Quantity

Item

1

SL600 Vital signs monitor

1

NIBP Cuff for adult (10.0 – 13.5 inch / 25.3 – 34.3 cm)

1

NIBP Cuff for paediatric (6.2 – 8.4 inch / 15.8 – 21.3 cm)

1

NIBP Hose for adult/paediatric

1

Temperature Probe with Temperature option configured

1

Temperature Probe Cover with Temperature option configured

1

SpO2 Sensor with SpO2 option configured

1

Pulse Oximetry Cable with SpO2 option configured

1

Operator’s Manual

1

Power Cord (applicable to country of sale)

1 pack

Printer Paper with Printer option configured

A range of additional accessories are available for the Smartsigns® Liteplus. Please contact 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 the specified voltage and frequency (100-240 VAC, 50-60 Hz).

Setting up the Monitor

4.3

AC Power Connector Figure 3. AC Power Connection 1.

Connect the female connector end of the AC power cord to the monitor rear panel connector.

2.

Plug the male connector end of the AC power cord into a properly grounded AC outlet.

3.

Verify that the Charging/AC in Indicator is lit. This indicator will be flashing if the battery needs charging.

Note: If the Charging/AC in Indicator is not lit, check: the power cord the AC power inlet

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