Smartsigns Compact SC1200 and 1500 Instructions for Use April 2021

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WARNING To avoid injury, always read this Instructions for use and accompanied documents before using the product. Mandatory to read the Instructions for use.

Please Note: These Instructions For Use apply to both SC1200 and SC1500 Multi-Parameter Patient Monitors. The information applies to both models, where the model identifier appears in a heading, it means that the following content applies to that model only.

Smartsigns and Huntleigh are registered trademarks of Huntleigh Technology Ltd. 2018. 2

Nellcor OxiMax® is a trademark of Covidien AG

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Table of Contents 1. Safety Instructions... 8 1.1 1.2 1.3

Warnings...8 Infection Control...9 Patient Applied Parts...9

2. Introduction... 10 2.1 2.2 2.3 2.4 2.5 2.6

Intended Use...10 Contra-Indications... 11 Personal Security Information... 11 Expected service life... 11 Unpacking / Preliminary Checks...12 Basic operation and Controls...13

3. Product Identification... 14 3.1

3.2 3.3 3.4 3.5 3.6

3.7

Front Panel...14

3.1.1

Function Keys...15

Base...15 Rear Panel...16 Left Side Panel...17 Right Side Panel...17 Display ...18

3.6.1 3.6.2 3.6.3 3.6.4

Waveform Area...18 Parameter Area...18 Upper Menu Bar...19 Lower menu bar...19

Product Labelling...20

4. System Setup ... 21 4.1 4.2 4.3

System Connection...21 Patient Connections...21 Handling and Mounting...22

5. Operation ... 23 5.1 5.2 5.3 5.4 5.5 5.6

Switching the Unit ON...23 Shortcut keys...23 Standby Mode...23 Touchscreen Lock...23 Switching the Unit OFF...23 Main Menu ...24

5.6.1

General Setup...24

5.6.1.1

Patient Manage... 24

5.6.1.2

Alarm Setup... 24

5.6.1.3

Review... 24

5.6.1.4

Screen Config... 24

5.6.1.5

Screens... 26

5.6.1.6

Night Mode... 26

5.6.1.7

Volume Setup... 27

5.6.1.8

Calculator... 27

5.6.1.9

Patient Records... 27

5.6.1.10

Recorder Setup... 27

5.6.1.11 External Printer Setup... 27 5.6.1.12 Event Setup... 27 5.6.1.13 Parameter Setup... 28 5.6.1.14 Config Manage... 28 5.6.1.15 Load Config... 28

5.6.2

Maintain Menu...29

5.6.2.1 5.6.2.2

USER Maintain Menu... 29

Language Setup... 29

5.6.2.3 Smoothing... 29 5.6.2.4

Analogue Out... 29

5.6.2.5

Network Protocol... 30

5.6.2.6

Wave Fill Setup... 30

5.6.2.7

Time Setup... 30

5.6.2.8

Alarm Setup... 30

5.6.2.9

Touchscreen Calibrate... 30

5.6.2.10 Module Colour... 30 5.6.2.11 Units Setup... 30 5.6.2.12 Nurse Call Setup... 30 5.6.2.13 Module Setup... 31

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EN 5.6.2.14 Monitor Info... 31 5.6.2.15 Quick Key Config... 31 5.6.2.16 Wave Save... 31 5.6.2.17 ECG Calibrate... 32 5.6.2.18 NIBP Verify... 32 5.6.2.19 Leakage Test... 32 5.6.2.20 Format SD Card... 32 5.6.2.21 Resp Setup (extended)... 32 5.6.2.22 Save Tactics... 33 5.6.2.23 Other Setup... 34 5.6.2.24 Set User Password... 34 5.6.2.25 DEMO... 34

6. Configuration Management ... 35 6.1 6.2

Overview...35 Managing Configurations...36

6.2.1 6.2.2 6.2.3 6.2.4 6.2.5

Selecting a Department Configuration...36 Creating and Saving a User Configuration...36 Loading a configuration...37 Deleting a configuration...37 Importing a Configuration from USB...37

7. Patient Management ... 39 7.1 7.2 7.3 7.4 7.5 7.6

Patient concepts...39 Quick Admit...40 Admitting a Patient...40 Patient Information...41 Managing Patient Records...41 Discharge...43

8. User Interface... 44 8.1 8.2 8.3 8.4 8.5 8.6 8.7

Customising the Interface...44 Standard Display...45 Numerical Display...45 Trend...46 OxyCRG Display (Neonate mode only)...47 List Interface...48 Bed to Bed View...48

8.7.1

Controlling the bed to bed view...49

8.8 7-Lead ECG...50 8.9 7-Lead Half Screen...51 8.10 12 Lead ECG...51

9. Alarms... 52 9.1 9.2

9.3 9.4 9.5 9.6

9.7 9.9

Alarm Classification...52 Alarm Types...53

9.2.1 9.2.2

Non Latching Alarms...53 Latching Alarms...53

Visual alarm indicators ...54 Alarm tones ...54 Alarm status messages ...55

9.5.1 9.5.2

Parameter indication...55 Multiple alarms...55

Setting alarm limits...55

9.6.1 9.6.2 9.6.3 9.6.4 9.6.5 9.6.6 9.6.7 9.6.8 9.6.9

Setting the alarm limits and priorities...55 Viewing all alarm limits...56 Setting Alarm AUTO limits...56 Switching ON alarm limits...57 Switching OFF individual alarms...58 Switching OFF all alarms...58 Setting Alarm OFF reminder...58 Pausing the Alarms...58 Setting the Alarm Pause Period...59

Setting the alarm volume...59

9.7.1 9.8.1

Setting the minimum alarm volume...60 Setting alarm events...60

Alarm System Self-test...60

10. Pulse Rate Setup... 61

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10.1 Overview...61 10.2 PR Source...61 10.3 PR Alarm Limit Setup...61

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11. ECG Monitoring... 62 11.1 11.2 11.3 11.4

Precautions...62 Introduction...62 Working with Paced Patients...63 Monitoring Steps...63

11.4.1 11.4.2 11.4.3

Skin preparation for electrode placement...63 Connecting the ECG Cable...64 ECG lead identification and placement ...64

11.4.3.1 Standard 3 Lead placement (IEC)... 65 11.4.3.2 Standard 5 Lead placement (IEC)... 65 11.4.3.3 Conventional 12 Lead placement (IEC)... 66 11.4.3.4 Recommended ECG Lead Connection for Surgical Patients... 66

11.5 ECG Display...67 11.6 ECG Setup...67

11.6.1 3, 5, 12 Lead selection...67 11.6.2 Setting the waveform Gain...67 11.6.3 Setting the ECG filter ...68 11.6.4 Notch Filter Setting...68 11.6.5 Monitoring PACED patients...69 11.6.6 Setting the HR calculation lead...69 11.6.7 Multi Lead Analysis...69 11.6.8 Cascade...69

11.7 ST Segment Analysis...70 11.7.1 11.7.2 11.7.3 11.7.4 11.7.5 11.7.6

Introduction to ST segment analysis...70 Influence on ST Segment...71 ST Analysis On/Off...71 Setting the ST measurement point...71 ST Analysis Review...72 ST Alarms...72

11.8 Arrhythmia Analysis...73 11.8.1 11.8.2 11.8.3 11.8.4 11.8.5

Switching Arrhythmia Analysis On/Off...73 Arrhythmia Alarm Setup...73 Adjusting the arrhythmia alarm threshold...73 Arrhythmia Review...73 ARR Relearning...74

11.9 ECG Relearn...74 11.10 Defibrillator Synchronization...74

12. Respiration Monitoring... 75 12.1 Respiration Measurement...75 12.2 Placement of Electrodes...75 12.2.1

Optimization of Lead Position...75

12.3 Respiration Display...75 12.4 Respiration Setup...76 12.4.1 Changing the size of the Respiration wave...76 12.4.2 Apnoea Alarm Delay...76 12.4.3 Changing the Speed of the Respiration Wave...76

13. SpO2 Monitoring... 77 13.1 Overview...77

13.1.1 Identification of SpO2 technology...77

13.2 Safety...78 13.3 Accuracy verification...79 13.3.1 13.3.2

SpO2 Accuracy...79 PR Accuracy...79

13.4 SpO2 Waveform (Huntleigh)...79 13.5 SpO2 Setup (Huntleigh)...79 13.5.1 Sweep speed...80 13.5.2 Signal IQ...80 13.5.3 NiBP same side...80 13.5.4 Sensitivity...81 13.5.5 Alarm set up...81

13.6 SpO2 Waveform (Nellcor Oximax) ...82 13.7 SpO2 Setup (Nellcor Oximax)...82 13.8 Monitoring steps...83

14. NIBP Monitoring... 84 14.1 Overview...84 14.2 Safety...84 14.3 NIBP Connections...85

14.3.1 NiBP Cuff selection and application...86 14.3.2 Limitations of measurement...86 14.3.3 NIBP Display...87

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Patient Type...88 Measurement Modes...88

14.4.2.1 Manual Mode... 88 14.4.2.2 Automatic Mode... 88 14.4.2.3 STAT Mode... 88

14.4.3 Target Pressure...89 14.4.4 Alarm Limit Setup...89 14.4.5 STAT measurements...90 14.4.6 Reset Module...90 14.4.7 Other Setup (EXTENDED Options)...90 14.4.7.1 Cuff Pressure (mmHg)... 90 14.4.7.2 Venous Puncture Start... 91 14.4.7.3 NiBP Analysis... 92 14.4.7.4 Dynamic Analysis Trend... 93

14.5 Start / Stop Manual BP Measurement...94 14.6 Start / Stop Automatic BP measurement...94

15. Temperature Monitoring... 95 15.1 Introduction...95 15.1.1

Measuring Temperature...95

15.2 Temperature Display...95 15.2.1

Alarm settings...96

16. IBP Monitoring... 97 16.1 Introduction...97 16.1.1 16.1.2 16.1.3 16.1.4 16.1.5 16.1.6

IBP labels...97 IBP Waveform Speed...98 Setting the IBP Filter...98 Optimising the IBP scales...99 Alarm settings...99 Systolic Pressure Variation - SPV Display...100

16.2 IBP Monitoring...100 16.2.1

Zero the Pressure Sensor...101

17. CO2 Monitoring... 103 17.1 Overview...103 17.2 CO2 Modules...104 17.3 Sensor Connections...105 17.3.1 17.3.2 17.4.1 17.4.2 17.4.3 17.4.4 17.4.5 17.4.7

Mainstream Sensor...105 Sidestream Sensors and sampling lines...106 Barometric pressure setting...107 O2 Compensation...108 Balance gas...108 Apnoea delay...109 Altitude Units...109 Alarm limit set up...110

17.5 Maintenance and Cleaning CO2 Sensors... 110

17.5.1 General Cleaning...110 17.5.2 Cleaning the Re-useable Airway Adapter...110 17.5.3 Disinfecting the Reusable Airway Adaptor...110

18. Managing Data... 111 18.1 18.2 18.3 18.4

Overview... 111 Waveforms... 111 Waveform Freeze... 112 Review... 112

18.4.1 Trend Review...113 18.4.2 NiBP Review...114 18.4.3 Alarm Event Review...114 18.4.4 Waveform Review...116

19. Recorder... 117 19.1 Description of Recorder... 117 19.2 Loading paper... 117 19.3 Recorder Printout... 118 19.3.1 Setting up the Recorder...118

19.4 Manual Operation... 119 19.5 Automatic Operation... 119 19.6 Recorder maintenance... 119 19.6.1 Clearing paper jam...119 19.6.2 Cleaning...119

20. External Printing... 120 6

EN 20.1 External printer specification...120 20.2 Report Printing ...120 20.2.1 20.2.2 20.2.3 20.2.4 20.2.5 20.2.6 20.2.7

NiBP report...121 Real Time Waveform report...121 Wave Review report...121 Alarm event report...122 Tabular Trend Report...122 Graphical Trend Report...123 Cancelling a report...123

20.3 Printer Error Messages...123

21. Extended Functionality... 124 21.1 21.2 21.3 21.4

Nurse Call...124 Central Monitoring System Interface ...124 ECG Analogue Output...125 Formatting SD card...125

22. Battery... 126 22.1 22.2 22.3 22.4

Introduction...126 Battery installation ...127 Battery optimisation...127 Battery Recycling...128

23. Cleaning... 129 23.1 23.2 23.3 23.4

Cleaning and Disinfecting the Monitor...129 Cleaning and Disinfecting BP cuffs ...130 Cleaning and disinfecting SpO2 sensors...130 Precautions...130

24. Maintenance... 132 24.1 24.2 24.3 24.4

User maintenance Daily Checks...132 Scheduled Technical maintenance...132 Corrective maintenance...132 Servicing...132

25. Technical Specifications ... 133 26. System Alarm Messages... 140 26.1 Physiological Alarm Messages ...140 26.2 Techniical Alarm Messages...142 26.3 System Prompt Messages...144

27. Default Configuration... 145 27.1 General Configuration...145 27.2 Default Alarm Limits...147 27.3 Default Configuration...148

27.3.1 ADULT/PED Alarm Ranges and Default Limits... 148 27.3.2 ADULT/PED Alarm Ranges and Default Limits... 149 27.3.3 Arrhythmia Alarm Defaults... 149

27.4 Default Configuration...150

28. Electromagnetic Compatibility... 153 29. Toxic/Hazardous Substances/Elements... 157 30. End of Life Disposal... 158 31. Warranty & Service... 159 Appendix A Accessories... 160 Recommended accessories... 160

Appendix B Clinical Evaluation ... 163 SPO2 Summary Report ...163 NIBP Summary Report ...163 CO2 Summary Report ...164

Appendix C CO2 LoFlo interfering gasses vapours... 165

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1. Safety Instructions Symbols General Warning Attention, consult this manual. Refer to safety section. Refer to Instructions for Use.

1.1

8

Attention, consult accompanying documents / Instructions for Use.

Warnings WARNING This equipment is for use only by suitably qualified healthcare practitioners.

WARNING Do not use in the presence of flammable gases, pharmaceuticals in aerosols or in oxygen rich environments.

WARNING The monitor is intended only as an adjunct to patient assessment. It must be used in conjunction with clinical signs and symptoms.

WARNING SC1200/SC1500 are Class 1 products that rely for safety on their protective earth. Ensure it is connected to a suitably earthed AC mains supply.

WARNING Do not use if there is any damage to the unit or its accessories.

WARNING When configuring the system, consider and minimise the risk of persons tripping over cables.

WARNING Alarm upper and lower limits should be set depending on the patient. Do not rely exclusively on the audible alarm system.

WARNING If this product is connected to another item of electrical equipment, ensure that the system is fully compliant with IEC60601-1.

WARNING Do not use the SC1200/SC1500 in vehicles or in aircraft.

WARNING This equipment must not be modified.

WARNING During defibrillation, the operator should not come into contact with the patient, the monitor or the supporting table; otherwise serious injury or death could result.

WARNING After defibrillation, the electrocardiogram (ECG) waveform will recover within 5s, other parameters will recover within 10s.

WARNING This unit is not MRI compatible and must not be used in an MRI environment.

WARNING Do not make contact with exposed metal parts and the patient simultaneously.

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WARNING Patients with a pacemaker must be observed continuously because the heart rate from the pacemaker may still register in the case of a cardiac arrest or certain arrhythmias. Do not rely on alarms.

WARNING This product contains sensitive electronics, therefore, strong radio frequency fields could possibly interfere with it. This may be indicated as a disturbance on the physiological waveform. We recommend that the source of interference is identified and eliminated.

WARNING This equipment must be connected directly to the mains outlet. Any additional multiple socket outlet or extension cord shall not be connected to the ME System.

WARNING Mains isolation is achieved by disconnecting the mains connector to the rear of the SC1200/SC1500 or unplugging from the mains supply. Do not position the ME equipment such that it makes it difficult to disconnect the supply.

WARNING Connect only Items that have been specified as part of the ME system or have been specified as being compatible with the ME system.

CAUTION Use only recommended accessories listed in this manual.

CAUTION Do not expose to excessive heat, including prolonged exposure to sunlight.

CAUTION The SC1200/1500 is restricted to single patient use.

NOTE Place the monitor at a position where observation, operation and maintenance is convenient.

NOTE This IFU is based on the maximum configuration. Some content and displays may not be applicable to your monitor.

1.2

Infection Control

The system uses a mixture of reusable and single use accessories, refer to section 24 for specific details.

1.3

Patient Applied Parts

As defined in IEC60601-1:2005, the patient applied parts of the Smartsigns® Compact 1200 and 1500 Multiparameter Patient Monitors are the: • • •

ECG Cable Blood Pressure cuff IBP sampling lines

• • •

SpO2 Sensor Temperature sensor CO2 Sampling lines

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2. Introduction The Huntleigh Smartsigns® SC1200 / SC1500 are high performance Multi-Parameter Patient Monitors which are capable of performing short, medium and long term monitoring of Adult, Paediatric and New-born patients. The SC1200 / SC1500 can monitor the following parameters: • • • • • • • •

2.1

ECG Respiration Oxygen Saturation Non-invasive Blood Pressure Body Temperature Carbon Dioxide Concentration Invasive Blood Pressure (IBP) ST segment and Cardiac Arrhythmias

Intended Use

The SC1200 / SC1500 Multi-parameter Patient Monitors are indicated for use by trained healthcare professionals for the monitoring of Adult, Paediatric and Neonate physiological vital signs. They can be used in a variety of healthcare settings (but not limited to) triage departments, general wards, specialist wards, operating rooms, ICU, CCU and NICU. The SC1200 / SC1500 Multi-parameter Patient Monitors provide the following functionality: • • • • • • • •

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ECG 3, 5 and 12 lead S-T elevation and depression measurement Arrhythmia detection and analysis Respiratory rate Blood pressure – invasive and non-invasive measurements Oxygen saturation Body temperature CO2 respiratory function and output

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2.2

Contra-Indications

The device is not intended for use outside a Healthcare facility. No absolute contraindications exist for ECG monitoring, however, clinicians should be aware of situations developing as a result of certain allergies caused by sensitivity to adhesives used to fix electrodes onto the skin. Pulse oximetry is contra indicated for use on active patients or for prolonged use. To prevent tissue damage, sensor position should be checked every 4 hours and re-positioned if necessary (as indicated by circulatory status and or skin integrity). When using wrap type of sensors, do not apply tape to close the sensor, venous pulsation may compromise measurements. Oral temperature measurement is contraindicated if the patient has impaired mental illness or has evidence of oral disease. Rectal and oesophageal temperature measurement in Neonatal patients is contra indicated. Rectal measurements in patients who have had rectal or cardiac surgery or have low white blood cell count is contraindicated. The automated NiBP function is contraindicated for use with pregnant patients including those who exhibit signs of pre-eclampsia. Prolonged use and frequent BP determination can lead to venous pooling and or congestion, avoid continuous long term measurements on high risk patients. The blood pressure cuff should not be placed on the same arm which is attached to an SpO2 sensor, restricted circulation may affect measurements. Sidestream CO2 monitoring should not be offered to patients who cannot tolerate the withdrawal of 50mL/ min from the airway or patients who cannot tolerate the additional dead space to the airway. Exposing neonates and pregnant women to accessories which contain PVC plasticised with DEHP treatment time should be limited.

2.3

Personal Security Information

The SC1200 / SC1500 operate in an environment where personal and sensitive data is available, whilst the system offers various levels of access, it is the responsibility of the institution to develop and implement appropriate security measures to comply with local regulations and safeguard personal data.

2.4

Expected service life

This has been defined as the minimum time period during which the device is expected to remain safe and suitable to meet its intended use, and all risk control measures remain effective. Huntleigh Healthcare Ltd’s commitment is that the expected service life for this Device has been defined as 7 years.

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2.5

Unpacking / Preliminary Checks

We recommend that a thorough visual inspection is made immediately the unit is received. Should any damage be evident or any parts missing, ensure that Huntleigh Healthcare Ltd is informed at once. Each configuration is supplied with a starter pack of accessories, these include: 12.1" / 15" Patient Monitor - ECG (3/5), SpO2, NiBP, Resp, Temp (2) Each base configuration is supplied with: 1 x 5 Way ECG cable (IEC) - ADU / PED, or 1 x 3 Way NEO cable (IEC) 1 x NiBP cuff set (3) - ADU, PED or NEO SC1200 / 1 x NiBP Hose (3M) SC1500 Base 1 x SpO2 sensor - ADU, PED or NEO configuration 1 x Temp sensor - ADU, PED or NEO 1 x Grounding cable 1 x Power cord 1 x Instructions for use 12 Lead ECG Option 1 Supplied with: 1 x 12 Way ECG cable (IEC) Nellcor Oximax SpO2 Supplied with Option 2 1 x SpO2 Interface cable 1 x SpO2 Sensor - ADU, PED or NEO Invasive Blood Pressure (internal) Supplied with: Option 3 2 x IBP interface cables (Abbott) 2 x Disposable pressure transducers (Abbott) Invasive Blood Pressure (expansion module) Supplied with: Option 4 2 x IBP interface cables (Abbott) 2 x Disposable pressure transducers (Abbott) EtCO2 Side stream (expansion module) Option 5 Supplied with: 1 x Sampling line - ADU, PED or NEO EtCO2 Main stream (expansion module) Supplied with: Option 6 1 x Main stream sensor 1 x Interface cable 1 x Disposable airway adaptor - ADU, PED or NEO Integrated Recorder Option 7 Supplied with: 1 x Roll paper

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2.6

Basic operation and Controls

System management and controls are affected through a hierarchical menu structure with three levels of access control - Basic, Advanced and Engineer. Each level provides access to certain features and functionality described in the table below: Access level

Description

Functionality

Access to Protection patient records method

Basic

Normal use

User interface and controls only

No

None

Advanced

User maintenance

Full system administration

Yes

Password *

Engineer

Factory maintenance

Engineering functionality – establishing and uploading specific profiles, adjustment of local default settings, system calibration etc.

No

Password *

* Refer to your technical support department for password information.

System

Access level

Basic

Adv

Eng

System menu structure

The flexibility of the system means that the operator can access the same control from different areas of the system, for example, the on-screen menus and system sub menu control can be accessed through: • Physiological waveform • Numerical area of the screen • Soft keys • Smart keys • Membrane key pad • Jog dial The recommended operating position is in front of the device.

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3. Product Identification WARNING Safety and performance can only be assured when the system is used in conjunction with the correct types of accessory. Do not attempt to use any devices other than those supplied or recommended by Huntleigh.

3.1

Front Panel 7

2

14

8

3

4

1

6 5

1

Touchscreen

5

Function keys

2

On/Off Button

6

Jog Dial

3

AC supply / Battery status LED

7

Physiological Alarm Indicator

4

Battery charging LED

8

Technical Alarm Indicator

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3.1.1 Function Keys Symbol Explanation

3.2

Acknowledge Alarm

Pause Alarm

Freeze / Unfreeze Waveform

Record Start / Stop

BP Start / Stop

Main Menu

Base 1

1

Battery Compartment

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3.3

Rear Panel 1

3

2

4

5

6

7

8

9

1

Loudspeaker

6

USB Port x 2

2

Carry Handle

7

Ethernet Port

3

Expansion module *

8

Rating Label

4

VGA Port

9

Equipotential earth point

5

Multifunctional Interface

10 Mains Socket

10

* Depending on model/options purchased.

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3.4

Left Side Panel 1

1

Carry Handle

2

Expansion module *

3

Sensor connections

1

Printer

2

3

3.5

Right Side Panel

1

* Depending on model/options purchased.

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3.6

Display

This monitor uses a backlit colour LCD display with integrated touch screen. Physiological parameters, waveforms, alarm messages, date and time, network connection status, battery level and other messages are displayed simultaneously. The screen is divided into four areas: • • • •

Waveform area Parameter area Upper menu bar Lower menu bar

Parameter Area

Waveform Area

Upper Menu Bar

Lower Menu Bar

3.6.1 Waveform Area • •

8 waveforms can be displayed, along with the respective identification Touch a waveform to display the corresponding setup menu.

3.6.2 Parameter Area • • •

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Displays measured parameters Parameter is displayed in the same colour as the waveform Touch a parameter to display the corresponding setup menu

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3.6.3 Upper Menu Bar Physiological Alarm Status

ADU Patient Group

Technical Alarm Status

Patient Name

Date & Time

Pacer Status

This area includes the following sections from left to right: • Physiological alarm message: Displays the alarm messages. If there are multiple alarms, each one will be displayed in turn. Touch the message to view the 'Physiological Alarm' , except when high priority alarms, such as Asystole, Ext Bradycardia ,Ext Tachycardia and VF/VT alarms are displayed. • Technical alarm message: Displays technical alarm messages. If there are multiple alarms, each one will be displayed in turn. Touch the message to enter the 'View Technical Alarm' window. • • •

, Alarm Off , Alarm Mute Alarm Status icons : Alarm Pause Patient data - Displays the patient name, type, and pacemaker status. Time and date.

3.6.4 Lower menu bar This menu contains the shortcut keys or smart keys. The presentation will depend upon the configuration of the monitor. 1

Main Menu

1

1

Record

NIBP Start

Screens

Review

2

Alarm Setup

Scroll left/right to show more shortcut keys Monitor setup area: Central Monitoring System (CMS) status, SD card status, battery status, USB drive status

2

CMS enabled

CMS disabled

SD card inserted

SD card not inserted

Battery status

USB flash drive connected

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3.7

Product Labelling

Symbol Explanation 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. This symbol signifies that this product complies with the essential requirements of the Medical Device Directive (93/42/EEC) - Medical Device Regulation (EU/2017/745) Huntleigh Healthcare Ltd.

35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 [email protected] www.huntleigh-diagnostics.com Legal Manufacturer in association with the CE mark in Europe ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden

Manufactured By:

YYYY-MM

CF Applied parts, with defibrillation proof function

BF Applied parts, with defibrillation proof function

Warning

Attention, consult accompanying documents / Instructions for Use

~

Alternating current (AC)

On/Off

DI

Device Identifier

SN

Serial Number (Date of manufacture is included in SN)

Multi-function Interface

USB Port

Ethernet Port

Network Interface

Equipotential Earth

Reset alarm

Pause alarm

Freeze / Unfreeze waveform

Record Start/Stop

Start BP measurement

Main menu

Medical Device

Fragile

Keep Dry

Cardboard packaging can be recycled.

Atmospheric Pressure Limits

Humidity Limitations

MD

50°C

-10°C

PVC

YYYY-MM

Temperature Limits

REF

LATEX

Does not contain PVC Use By Max stack of x 4 identical boxes

Reference Number

Not made with natural rubber latex. Do Not Reuse

IPX1

Protection against vertically falling water drops This way up * As defined by IEC60601-1.

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