Smartsigns LitePlus Instructions for Use

1. General Safety Information ...5 1.1 1.2

Warnings ... 5 Cautions ... 7

2.1 2.2 2.3

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

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 Controls... 16

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

5.1 5.2 5.3

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

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

7.1 7.2 7.3 7.4

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

8.1 8.2 8.3 8.4

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

9.1 9.2 9.3 9.4

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

2. Introduction ...8

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

Table of Contents

Contents

4. Setting up the Monitor...17

5. Battery Operation ...22

6. Using the Monitor ...24

7. NIBP Monitoring...34

8. SpO2/Pulse Rate Monitoring...41

9. Temperature Monitoring ...46

3

Table of Contents

10. Alarms And Limits ...54 10.1 10.2 10.3 10.4

General ... 54 Setting Alarm Limits ... 55 Alarm Silence ... 61 Verifying Visual and Audible Alarm Indication ... 61

11.1 11.2 11.3 11.4

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

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

13.1 13.2 13.3

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

14.1 14.2 14.3 14.4 14.5 14.6 14.7

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

15.1 15.2 15.3 15.4

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

16.1 16.2

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

17.1 17.2 17.3 17.4 17.5 17.6 ...

Physical... 80 Electrical ... 80 Environmental ... 80 Measurement Parameters ... 81 Compliance ... 83 Manufacturer’s Declaration ... 86 Service Returns ... 90

11. Reviewing Patient Data ...62

12. Printing ...65

13. RS232 Interface ...70

14. Maintenance ...72

15. Troubleshooting ...75

16. Factory Defaults ...79 17. Specifications ...80

4

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 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: Do not touch the monitor when a defibrillator is being discharged (electrified), as doing so may cause electric shock. NIBP monitoring only in this monitor is protected against the discharge of a defibrillator. The other functions (SPO2, TEMP) are not protected. Please be sure of no other patient connections, except NIPB, before using the defibrillator. 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. WARNING: Before use, carefully read sensor or probe directions for use, including all warnings, cautions, and instructions.

5

General Safety Information

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. WARNING: To avoid burns, the temperature probe must remain in the probe well when turning the monitor on or off. WARNING: Do not connect more than one patient to the monitor. Do not connect more than one monitor to a patient.

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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 Smartsigns® Liteplus 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 Cautions

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. 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 IEC60601-1-2. If in doubt, contact Huntleigh Healthcare Technical Services Department.

7

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: Features

Config. NB

Standard (NIBP + Pulse Rate + Ni-MH Battery)

NSB

Standard + SpO2

NTB

Standard + Temperature

NSTB

Standard + SpO2 + Temperature

NPB

Standard + Printer

NSPB

Standard + SpO2 + Printer

NTPB

Standard + Temperature+ Printer

NSTPB

Standard + SpO2 + Temperature + Printer

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, 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 Smartsigns® Liteplus vital signs monitor is a lightweight and compact vital signs monitor measuring 130×180×284 (mm) (H×D×W) and weighing 2.7 kg. Its carrying handle is designed for instrument transport while battery-powered monitoring.

Electrical The monitor is powered by a Ni-MH type of internal battery pack. The batteries are continuously recharged when AC power (100-240 VAC, 50-60 Hz) is connected to the monitor. Details are described in the Battery Operation section.

8

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

Auxiliary Outputs The 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

Introduction

Display

Intended Use

The purpose and function of the Huntleigh Healthcare Smartsigns® Liteplus 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, landbased 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. 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, especially the alarm limit or alarm notification settings, 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 patient monitor.

2.3

About This Manual

This manual explains how to set up and use the Smartsigns® Liteplus vital signs monitor. Important safety information relating to general use of the monitors 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 Smartsigns® Liteplus 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

3.

Description of Controls, Indicators, Symbols and Displays

3.1

Identification of Front Panel Controls and Symbols 28 27 26 25

SYS

1 2

mmHg 1

kPa BP

°F

3

DIA

°C

/min

M

4 %SpO2

5 6

20

MAP

7

smartsignsLitePlus ®

8

9

10 11

12

13 14

15

16 17 18 19

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

NIBP start/stop button

8

Print Button

22

Temperature Unit/Mode Indicators

9

Alarm Button

23

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

10

24 23 22 21

Identification of Rear Panel Components and Symbols

1

2 NiMH

3 4

5

6

7

1

Handle

4

Equipotential (Ground)

2

Air Ventilator

5

Battery Cover (Replacement)

3

AC Power Connector

6

Battery Label

7

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 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.

13

Description of Controls, Indicators, Symbols and Displays

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.

AC Power Rating Input

Disposal Instructions

14

Description Manufacturer

Date of Manufacture

CE Mark

PATIENT MONITOR 32MX E252514 UL60601-1 CAN/CSA C22.2 No.601.1

UL Mark

IPX2

Dust and Water Resistance

REF

Reference Number

SN

Serial Number

500-1060 hPa

Environmental shipping / storage temperature limitations o

50 C

o

-20 C

Fragile - Handle with Care

This Way Up

Description of Controls, Indicators, Symbols and Displays

Symbols

Keep Dry

15

Description of Controls, Indicators, Symbols and Displays

3.4

Description of Controls Table 2. Controls

Controls

Description Power Button turns the 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. 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.

16

Setting up the Monitor WARNING: The Smartsigns® Liteplus 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® Liteplus 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. NIBP monitoring only in this monitor is protected against the discharge of a defibrillator. The other functions (SPO2, TEMP) are not protected. Please be sure of no other patient connections, except NIPB, before using the defibrillator. WARNING: Ensure that the speaker is clear of any obstruction. Failure to do so could result in an inaudible alarm tone. CAUTION: If the Smartsigns® Liteplus 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.

17

Setting up the Monitor

4.1

Unpacking and Inspection

The Smartsigns® Liteplus 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. Set the monitor to the user’s intended position where the user can easily recognise the visual and audible monitoring conditions. Normally it is recommended to set at a distance of 1 metre from the user. Also, the viewpoint is at any point within the base of a cone by an angle of 30° to the centre of the monitoring display.

4.2

List of Components Quantity

Item

1

Smartsigns Liteplus Vital signs monitor

1

NIBP Cuff adult (23 - 33 cm)

1

NIBP Cuff small adult (17 - 25 cm)

1

NIBP Cuff child (12 - 19 cm)

1

NIBP Hose 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.

18

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. 2. 3. 4.

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

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

19

Setting up the Monitor

4.4

Measurement Cable Connections 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.

NIBP Hoses and Cuffs

SYS

mmHg

NIBP Cuff Hose Connector

kPa

1

BP

°F DIA

°C

/min

M

%SpO2 MAP

smartsignsLitePlus ®

Figure 4. NIBP Cable Connections 1.

Select the appropriate size cuff for the patient (Refer to the NIBP Monitoring section) and apply the cuff to the selected site.

2.

Connect the hose to the right panel NIBP connector (see Figure 4). Note: For the safety of patients, and to ensure the best product performance and accuracy, use only a cuff and a hose provided with the Smartsigns® Liteplus, or a cuff and hose recommended by Huntleigh Healthcare Ltd Technical Services.

4.5

SpO2 Cables and Sensors

SpO2 Sensor/ Cable Connector

Figure 5. SpO2 Sensor/Cable Connections

20

1.

Select an appropriate sensor for the patient and desired application.

2.

Apply the sensor to the selected site.

3.

Connect the sensor to the cable.

4.

Connect the cable to the right panel SpO2 connector (see Figure 5).

4.6 Temperature Probes Temperature Probe SYS

Temperature Probe Well

mmHg

kPa

1

BP

°F DIA

°C

/min

M

Temperature Probe Cover

%SpO2 MAP

Temperature Probe Connector

Setting up the Monitor

Note: For the safety of patients, and to ensure the best product performance and accuracy, use only Huntleigh Healthcare Ltd provided tsensor pulse oximetry cables and SpO2 sensors.

smartsignsLitePlus ®

Figure 6. Temperature Probe Connections

1.

Insert the plug into the compatible jack on the monitor right panel. Note: For the safety of patients, and to ensure the best product performance and accuracy, use only Huntleigh Healthcare Ltd provided temperature probes (see Figure 6). Note: The temperature probes are available from Huntleigh Healthcare Ltd sales department. For the safety of patients, and to ensure the best product performance and accuracy, use only temperature probes that have passed the recommended biocompatibility testing in compliance with ISO10993-1.

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