Page 1 INSTRUCTIONS FOR USE SC1200 & SC1500 Multi-Parameter Patient Monitors 782498EN-6 04/2021...
Page 2 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. Nellcor OxiMax is a trademark of Covidien AG...
Page 3: Table Of Contents
Table of Contents 1. Safety Instructions ....................... 8 Warnings ..................................8 Infection Control ...............................9 Patient Applied Parts ..............................9 2. Introduction ........................10 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 ......................
Page 4 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 .......................................
Page 5 13.1 Overview ..................................77 13.1.1 Identification of SpO2 technology................................77 13.2 Safety ..................................78 13.3 Accuracy verification..............................79 13.3.1 SpO2 Accuracy......................................79 13.3.2 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...
Page 6 14.4 NIBP Setup ................................87 14.4.1 Patient Type ......................................88 14.4.2 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) ....................................
Page 7 20.1 External printer specification ..........................120 20.2 Report Printing ..............................120 20.2.1 NiBP report ......................................121 20.2.2 Real Time Waveform report ................................121 20.2.3 Wave Review report ....................................121 20.2.4 Alarm event report ....................................122 20.2.5 Tabular Trend Report...................................122 20.2.6 Graphical Trend Report ..................................123 20.2.7 Cancelling a report ....................................123 20.3 Printer Error Messages ............................123 21.
Page 8: Safety Instructions
1. Safety Instructions Symbols General Warning Attention, consult this manual. Refer to safety section. Refer to Instructions for Use. Attention, consult accompanying documents / Instructions for Use. Warnings WARNING WARNING This equipment is for use only by suitably Do not use in the presence of flammable qualified healthcare practitioners.
Page 9: Infection Control
WARNING WARNING Patients with a pacemaker must be This product contains sensitive observed continuously because the heart electronics, therefore, strong radio rate from the pacemaker may still register frequency fields could possibly in the case of a cardiac arrest or certain interfere with it.
Page 10: Introduction
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: • • Respiration • Oxygen Saturation •...
Page 11: Contra-Indications
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. 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.
Page 12: Unpacking / Preliminary Checks
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)
Page 13: Basic Operation And Controls
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 to Protection Access level Description Functionality patient records method Basic Normal use User interface and controls only None User Advanced Full system administration Password * maintenance Engineering functionality –...
Page 14: 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. Front Panel Touchscreen Function keys...
Page 15: Function Keys
3.1.1 Function Keys Symbol Explanation Acknowledge Alarm Pause Alarm Freeze / Unfreeze Waveform Record Start / Stop BP Start / Stop Main Menu Base Battery Compartment...
Page 16: Rear Panel
Rear Panel Loudspeaker USB Port x 2 Carry Handle Ethernet Port Expansion module * Rating Label VGA Port Equipotential earth point Multifunctional Interface Mains Socket * Depending on model/options purchased.
Page 17: Left Side Panel
Left Side Panel Carry Handle Expansion module * Sensor connections Right Side Panel Printer * Depending on model/options purchased.
Page 18: Display
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 •...
Page 19: Upper Menu Bar
3.6.3 Upper Menu Bar Physiological ADU Patient Patient Date & Alarm Status Group Name Time Technical Alarm Pacer Status 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.
Page 20: Product Labelling
Device Directive (93/42/EEC) - Medical Device Regulation (EU/2017/745) Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom Manufactured By: T: +44 (0)29 20485885 sales@huntleigh-diagnostics.co.uk www.huntleigh-diagnostics.com Legal Manufacturer in association with the CE mark in Europe ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden...
Page 21: System Setup
Huntleigh representative. If non-medical equipment (e.g. printer) with enclosure leakage currents greater than those allowed by IEC60601-1 is to be used in the patient environment (within 1.5m of the patient), the enclosure leakage currents must be brought within the limits laid down by IEC60601-1.
Page 22: Handling And Mounting
Handling and Mounting Mobile Stand WARNING If the product is being used on a trolley, make sure the trolley brakes are applied when stationary. WARNING Take care to ensure that trailing cables and other connecting leads do not present trip hazards that could lead to the equipment falling.
Page 23: Operation
5. Operation Switching the Unit ON WARNING If an error message is displayed, do not use the monitor. Disconnect from the mains supply and contact your service department. NOTE The system will sound an alarm if it detects a problem during the start up process. Connect the monitor to the local mains supply.
Page 24: Main Menu
Main Menu 5.6.1 General Setup Press the key on the screen or the button on the front panel to enter the Main Menu window. Main Menu Some menu options will be detailed in the relevant sections in this IFU. Main Menu Main Menu Main Menu Main Menu...
Page 25 Ambient Light Auto-tuning The user can turn on the ambient light auto function. This adjusts the screen brightness according to the ambient setting. Enter [Main Menu], [Screen Config], [Ambient Light Auto Tuning] Slide the switch to the ON position. Press to save and exit. Screen Layout Enter [Main Menu] → [Screen Config] → [Screen Layout]. In this window, you can adjust the position of waveforms and parameters. Only parameters that have been turned ON are shown on the screen.
Page 26: Screens
Privacy Mode In Privacy Mode, the monitoring data is not displayed on the screen. It can be activated only under CMS (Central Monitoring System) monitoring. To activate privacy mode: Enter [Main Menu] → [Screen Config] → [Privacy Mode]. When privacy mode is activated: The message [In monitoring...press any key to exit privacy mode!] is shown on the monitor screen. The monitoring continues normally but the patient data can be viewed only on the central monitoring station.
Page 27: Volume Setup
5.6.1.7 Volume Setup This setting controls the alarm, QRS, Pulse and key press volume levels. Select the [Volume Setup] shortcut key, or enter [Main Menu] → [Volume Setup]. Select [Alm Vol] : Set the level between 2 (the lowest volume, which depends on the setting of the Minimum Alarm Volume) and 10 (the loudest volume). See the 'Alarms' Section 9 for more details; Select [QRS/Pulse Volume]: Sets the appropriate volume within 0~10; Select [Pulse Volume]: Sets the appropriate volume within 0~10; Select [Key Vol]: Sets the appropriate volume within 0~10. Press to save and exit. 5.6.1.8 Calculator Future release 5.6.1.9 Patient Records See Section 7 5.6.1.10 Recorder Setup See Section 20. 5.6.1.11 External Printer Setup See Section 21.
Page 28: Parameter Setup
5.6.1.13 Parameter Setup Adjustments to each of the monitoring parameters can be accessed using any the following methods: • Waveform Area • Parameter Area • Short cut key Using ECG as an example: Waveform Area Parameter Area Press the ECG waveform to display Press the ECG parameter area to the [ECG Wave] set up options: display the [ECG set up] options: ECG Setup Lead Type 3 Leads Calculate Lead Alarm Limit Setup ST Analysis Arr Analysis...
Page 29: Maintain Menu
5.6.2 Maintain Menu Some monitor settings are found in a secure menu. To access this menu, the operator must enter a 4 digit password. (Refer to your technical support team for the password code). 5.6.2.1 USER Maintain Menu CAUTION The USER maintain menus are password protected and should only be accessed by authorised personnel.
Page 30: Network Protocol
To facilitate data transfer between the monitor and the central nurses system, the appropriate network protocol must be established. Refer to your technical support department for relevant information. Select [Net Protocol], select [Huntleigh], [Huntleigh OEM] or [HL7]. Make selection and press X to save selection.
Page 31: Module Setup
5.6.2.13 Module Setup With the exception of the ECG and SpO2 functions, modules can be enabled and disabled by the user. Select [Module setup], select appropriate module and select [On or Off]. Press X to save selection. 5.6.2.14 Monitor Info. In certain situations it may be necessary to inspect the monitors’ software status, in this case, select [Monitor info] and read the information displayed on the screen.
Page 32: Ecg Calibrate
5.6.2.17 ECG Calibrate The user can check the integrity of the ECG channel by applying a calibration signal to the system. Select [ECG Calibrate], the system will automatically apply a 1mV calibration signal to the ECG channel. 5.6.2.18 NIBP Verify Refer to your technical Service Manual for details.
Page 33: Save Tactics
Manual Mode Select [Resp Setup], [Mode] and select [Manual]. Having selected MANUAL, use the slider to set a value between 0 and 255. Press the tick to confirm selection. The thresholds should be positioned so that the respiration wave crosses both upper and lower levels. Upper Threshold (134) Respiration signal...
Page 34: Other Setup
5.6.2.23 Other Setup The Other setup option allows the user to setup the main notch filter and printer type. Notch Filter Select [Other Setup, [Notch Filter] and select [50Hz] or [60Hz] as appropriate Printer Type The monitor can support A4 format printer either through its USB connection or via a network port. Select [Other Setup], [Printer Type] and select [USB] or [Net] as appropriate. 5.6.2.24 Set User Password This feature cannot be accessed through the user maintain facility, refer to your engineering support team.
Page 35: Configuration Management
6. Configuration Management WARNING The Configuration Management menus are password protected and should only be accessed by authorised personnel. Overview WARNING Care should be taken when importing USER configurations not to inadvertently overwrite a configuration for another department. WARNING It must be noted that within a configuration, users can apply an additional level of adjustment and customisation during the monitoring session, these will not be saved when the patient is discharged or the system is switched off.
Page 36: Managing Configurations
Department General Ward NICU • Adult Default • Paediatric Configuration • Neonate USER Config 1 USER Config 1 USER Config 1 USER Config 1 USER Config 1 User USER Config 2 USER Config 2 USER Config 2 USER Config 2 USER Config 2 Configuration USER Config 3 USER Config 3 USER Config 3 USER Config 3 USER Config 3 Export All configuration files present on the SC1200/SC1500 are EXPORTED Import All configuration files on the USB flash drive are IMPORTED Managing Configurations The configuration management option is a protected area of the system and can only be accessed using a password. This feature should only be accessed by suitably qualified personnel. Adjustments applied from this area are significant. 6.2.1 Selecting a Department Configuration Up to five default departmental configurations are Config Manage Department...
Page 37: Loading A Configuration
Using the on screen keyboard, allocate a name Config Name for the configuration. ward5 Press the return key to confirm. The configuration will be automatically added to the configuration list. 6.2.3 Loading a configuration To load a new configuration, select {Main Menu], [Config Manage], enter password and select [Load Config]. The system will display the contents of the configuration list, make the necessary selection. A check box will be displayed, select [Yes] to load or [No] to return to the previous screen.
Page 38 6.2.6 Exporting a Configuration to USB Configurations can be saved and exported to a flash memory card Config Manage connected to the systems USB port. Startup Configuration Load Config Delete Config Import Config From USB Export Config To USB You can set up the configuration adopted by the Config Manage Startup Configuration monitor when it restarts. Department General In [Config Manage] menu, enter [Configuration on ->Use Last CFG Startup] and select from [Use Last CFG], [Default...
Page 39: Patient Management
7. Patient Management Patient concepts WARNING Always perform a discharge function to close the current monitoring session. Discharging the patient re-sets the equipment's default settings. Patients must be identified to the system so that data can be assigned correctly, they must be ADMITTED to the monitor to facilitate certain functionality associated with the monitoring session. ADMITTING a patient initiates specific algorithms which are used to calculate measurements as well as applying specific alarm limits. When a patient is DISCHARGED, the collection of data ends and is passed to the patient’s data file, the equipment default values are reset.
Page 40: Quick Admit
Quick Admit The QUICK ADMIT process requires you to enter minimum information: Select [Main Menu], [Patient Manage], [Quick Admit]. A warning check box appears, select [YES] to discharge the current patient and apply the data to a new patient, or [NO]to return to the previous screen.
Page 41: Patient Information
The Patient Information menu will be displayed, the user should complete as much of this information as possible – Surname, First name, Patient ID, Patient Type, Pacer Status, Sex, Date of Birth, Height, Weight, Blood Group. Patient Info Pay particular attention to the Patient Type and Pacer Status settings.
Page 42 NOTE When the monitor is shut down, the data applicable to the monitoring session is automatically saved. On startup, the system creates a new session. You can review, delete and export archived patient files, however, patient files can only be archived if the monitor is fitted with an SD card. Enter the patient name in the field at the lower left corner of the [Pat File Manage] window and Query click [Query] to search for the patient’s file. Select the patient info bar you want to review. Click [View] to open [Review] menu, in which View you can view [Patient Info], [Trend Review], [NIBP Review], [Alarm Event Review] and [Wave Review].
Page 43: Discharge
USB: Export to a USB flash drive. FTP: Export to a FTP server via wired network. Select [Data Export] to start export. When it is finished, the prompt message [Data export succeeded, please restart.] will be shown. • If multiple patient files are selected, operational steps are the same with those for single patient file except that [Start Time] and [End Time] cannot be set. Discharge WARNING After the patient is discharged, [Pace] will default to OFF. To discharge a patient from the monitor: Enter [Patient Manage] → [Discharge]. The system will display a prompt message [Discharge?]. •...
Page 44: User Interface
8. User Interface The monitor provides users with multiple interface options in the form of screens or displays: • Standard display • Numerical display • Trend display • OxyCRG display • List view • 7 Lead ECG display • 7 Lead ECG half screen display • 12 Lead ECG display Each display option will be dependent on the monitor configuration and can be selected to match the local clinical settings. It is possible to customise each interface so that it matches local requirements To select your desired user interface style: Select the [Screens] smart key, or select [Screens] under [Main Menu].
Page 45: Standard Display
Standard Display The monitor displays the Standard interface by default. The Standard interface can display up to 6 waveforms up to 8 data channels. Numerical Display The monitored parameters are shown in a large numerical format. The Numerical interface can display four parameters and four waveforms.
Page 46: Trend
Trend The Trend Interface displays a short term graphical trend with a combination of physiological waveforms and parameters. The user can customise the display by exchanging the position of the TREND information. Using the HR trend as an example, press the HR area of the display, a trend set up window will appear.
Page 47: Oxycrg Display (Neonate Mode Only)
OxyCRG Display (Neonate mode only) The OxyCRG display is a combination of a compressed display of the patients beat to beat heart rate, oxygen saturation and respiratory status. It is only available in the NEONATE MODE. Select the OxyCRG window to open the [OxyCRG] menu. Select the time length of OxyCRG trend.
Page 48: List Interface
List Interface The List interface occupies half of the waveform area. The user can review monitored parameters in this interface. Up to 9 sets of data are displayed on each page. Bed to Bed View The Bed to Bed view allows users to view measurements from other monitors. This feature is when the monitors are connected to a common network such as the CMS.
Page 49: Controlling The Bed To Bed View
The Bed to Bed interface includes: Physiological alarm message area: When multiple alarm messages exist, each one will be displayed in turn, except when High Priority mandatory alarms are present. Waveform area: You can select a waveform to open the setup window, and then set the waveforms to be displayed in the [Wave Exchange] menu. Network Identification: You can monitor another bed by entering its bed number in the CMS system. Technical alarm message area: When multiple technical alarm messages exist, each one will be displayed in turn Parameter area: You can click in this area to open the setup window, and select other parameters to be displayed. Function keys: [View Bed] - Select it to monitor another bed . [RESET] - Select it to reset alarms of another bed monitor. 8.7.1 Controlling the bed to bed view WARNING All data presented in the Bed to Bed view is delayed by several seconds.
Page 50: 7-Lead Ecg
7-Lead ECG When using the 5 lead ECG functionality, a full seven lead disclosure is available – I, II, III, aVR, aVL, aVF and V1 leads can be displayed.
Page 51: 7-Lead Half Screen
7-Lead Half Screen When using the 5 lead ECG functionality, a full seven lead disclosure is available together with three additional physiological waveforms. 8.10 12 Lead ECG When using the 12 lead ECG functionality, a full twelve lead disclosure is available – I, II, III, aVR, aVL, aVF, V1 –...
Page 52: Alarms
9. Alarms WARNING The use of different alarm configurations on different monitors in the same area (e.g., ICU or OR) may result in danger to the patient. Alarms are dynamic and respond to the physiological status of the patient, the information in this section applies to all measurements; however, certain measurements have specific characteristics which are detailed in their respective sections.
Page 53: Alarm Types
To aid the identification, each priority is assigned a different colour: • High priority, potentially life threatening e.g. asystole • Yellow Medium priority, lower priority e.g. respiration alarm violation • Cyan Low priority e.g. most INOP situations Alarm Types Both models supports latching and non-latching alarm functionality, the functionality differs and is described below: NOTE The latching functionality is not applied to Technical Alarms 9.2.1 Non Latching Alarms In an alarm condition, the audible and visual alert automatically resets itself if the parameter returns to the operating range.
Page 54: Visual Alarm Indicators
Visual alarm indicators There are two alarm indicators mounted on the upper left hand corner of the monitor, both illuminate with different colours and flash at different frequencies. Physiological Alarm: High RED (left indicator), flashing Medium Yellow (left indictor), flashing Yellow (left indictor), continuous Technical Alarm: High RED (left indicator), flashing Medium Yellow (left indictor), flashing Cyan (right indictor), continuous Alarm tones WARNING Both the bedside monitor and the CMS are provided with sound alarm function.
Page 55: Alarm Status Messages
The audible alarm tone is linked to the severity level in terms of the tone and repetition frequency High Beep Beep Beep - - Beep Beep - - Beep Beep Beep - - Beep Beep Medium Beep – Beep – Beep Beep Alarm status messages Colour coded status messages are shown in the alarm area in the upper menu area of the screen.
Page 56: Viewing All Alarm Limits
Range Current settings Upper limit Lower limit Alarm ON SAVE settings Alarm Event ON Increase settings Priority Decrease settings 9.6.2 Viewing all alarm limits The alarm limit window will list the alarm status and limits for all monitored parameters. Select [Main MENU], [Alarm Setup], [Alarm Limit Setup] to display the following screen: Use the ▼ key to scroll down the list.
Page 57: Switching On Alarm Limits
WARNING In the event of unexpected power loss, the equipment will retain the user adjusted alarm limits for a period of 120 seconds after which the system will revert to the selected limits specific to that configuration. WARNING If the alarm function is set to "OFF", the monitor cannot trigger an alarm when there is an alarm condition.
Page 58: Switching Off Individual Alarms
9.6.5 Switching OFF individual alarms Using ECG as an example, select the ECG parameter. Select [Alarm Limit Setup] Slide the HR toggle to the OFF position. When the alarm is switched OFF, a symbol ) appears in the corresponding area of the parameter section 9.6.6 Switching OFF all alarms Select [Main MENU], [Alarm Setup], [Alarm limit setup]...
Page 59: Setting The Alarm Pause Period
9.6.9 Setting the Alarm Pause Period Users can specify the alarm PAUSE period (1, 2, 3, 5, 10 or 15mins). This feature is accessed through the maintenance menu (password protected). Select [Main Menu], [Maintain], [enter password], [Alarm Reminder], [Alm Pause Time] Select [1 minute], [2 Minutes], [3 Minutes], [5 Minutes], [10 Minutes] or [15 Minutes].
Page 60: Setting The Minimum Alarm Volume
9.7.1 Setting the minimum alarm volume NOTE The audible level of the alarm is ≤85 dB. NOTE This function is password protected and should only be adjusted by your biomedical engineering team. To set the minimum alarm volume, enter [Main Menu], [Maintain], [Enter password], [Alarm Setup], [Min alm Volume], use the cursor to set the required level.
Page 61: Pulse Rate Setup
10. Pulse Rate Setup 10.1 Overview The monitor is able to derive the Pulse Rate from a range of different physiological sources. In all cases the colour of the Pulse Rate parameter will be consistent with the source. 10.2 PR Source Select the PR parameter area to enter the Setup menu, where you can set PR Source. PR Source PR Setup SpO2 PR Source...
Page 62: Ecg Monitoring
WARNING Prior to monitoring, please inspect the sensor cable for damage. WARNING Use ECG leads supplied by Huntleigh. WARNING Check for skin irritation at the ECG electrode site. If there is any sign of irritation, replace the electrode or change its position.
Page 63: Working With Paced Patients
The system uses primary and secondary lead selection to calculate HR and detect cardiac arrhythmias. Successful ECG monitoring should be based on waveforms which exhibit the following characteristics: • The QRS should be either above or below the baseline, it should never be bi-phasic. • The QRS complex should be tall and narrow •...
Page 64: Connecting The Ecg Cable
11.4.2 Connecting the ECG Cable Install the spring clip before placing the electrode onto the patients body. Insert the patient cable into the ECG port on the monitor. After a short while, the monitor will display the ECG wave and value. 11.4.3 ECG lead identification and placement Adopting a standardised approach to ECG monitoring is very important in obtaining optimised ECG signals for the diagnosis and management of cardiac patients, different leads in different positions can be used.
Page 65: Standard 3 Lead Placement (Iec)
12 Lead system Electrode label Electrode colour AAMI AAMI White Black Yellow Green Green Black Brown/Red White/Red Brown/Yellow White/Yellow Brown/Green White/Green Brown/Blue White/Blue Brown/Orange White/Orange Brown/Violet White/Violet 11.4.3.1 Standard 3 Lead placement (IEC) LA (Black) AHA Red electrode (R) — Place it below the Angle of L (Yellow) IEC clavicle, near the right shoulder.
Page 66: Conventional 12 Lead Placement (Iec)
11.4.3.3 Conventional 12 Lead placement (IEC) Conventional 12 lead ECG monitoring requires the use of 10 electrodes, an electrode is placed on each limb ( right arm, left arm, right leg and left leg), and six precordial leads are placed on the chest. In this case, the right leg electrode is used as the reference electrode.
Page 67: Ecg Display
11.5 ECG Display Up to twelve ECG waves can be displayed simultaneously of the system’s display, the actual configuration is defined by the settings in the ECG waveform menu. Lead name Arrhythmia analysis Gain Heart Rate Value 1mV scale bar Filter mode ECG Wave Alarm Limit 11.6 ECG Setup 11.6.1 3, 5, 12 Lead selection The monitor provides users with a 3, 5 or 12 lead ECG capability, this is controlled by the system’s hardware.
Page 68: Setting The Ecg Filter
11.6.3 Setting the ECG filter To ensure optimum levels of performance, the monitor is equipped with 4 different types of filter, the filter setting should match the monitoring environment. • MON – MONITORING filter to be used in general monitoring settings. • DIA – DIAGNOSTIC filter to be used when diagnostic quality is required. • SUR – SURGICAL filter when the system is being used in the OR with high frequency diathermy equipment • ST – ST filter when measuring ST segment. • The filter setting (MON, DIA, SUR, ST) is displayed on the ECG waveform: Select the ECG wave to enter the [ECG Wave] menu → [Filter Mode] → [Diagnostic], [Monitor] or [Surgical]. ST filter automatically enables when ST measurement is set to ON. 11.6.4 Notch Filter Setting The 50/60Hz notch filter removes any potential interference associated with the line frequency. The notch filter can be set ON/OFF or HIGH and LOW. When the ECG filter is set to MONITOR, the notch filter setting is automatically set to ON. When the ECG filter is set to DIAGNOSTIC, the notch filter can be switched ON/OFF or HIGH/LOW. Select the ECG parameter area to enter the Setup menu → [Other Setup] Set [Notch Filter] as follows: [High]: Narrow filter characteristics [Low]: Broad filter characteristics [Off]: Filtering will not be performed.
Page 69: Monitoring Paced Patients
11.6.5 Monitoring PACED patients NOTE When monitoring paced patients who display an intrinsic rhythm, the monitor may incorrectly count paced pulses as a normal QRS complex resulting in an incorrect heart rate, therefore identifying paced patients is essential for accurate HR computation. For example, certain pacemakers create “fusion beats”...
Page 70: St Segment Analysis
11.7 ST Segment Analysis 11.7.1 Introduction to ST segment analysis WARNING Certain clinical conditions may present specific challenges when monitoring ST segments: • Noisy ECG signals • Arrhythmias may cause irregular baseline and HR • Ventricular paced patients • Patient presenting with LBB In these situations, the user should consider switching off the ST measurement and seeking an alternative measurement method.
Page 71: Influence On St Segment
11.7.2 Influence on ST Segment WARNING This monitor provides information about changes in ST level, the clinical significance of which should be determined by the healthcare professional. Some clinical situations may result in difficulty to achieve reliable ST monitoring. For example: ◊ Presence of arrhythmia (e.g., atrial fibrillation/atrial flutter) that can cause irregular baseline. ◊ The patient is under continuous ventricular pacing. ◊ The patient has left bundle branch block. Under such circumstances, you should consider turning off ST monitoring.
Page 72: St Analysis Review
Setting the J point Set the J point (2) in relation to the R wave (1), use the ↔ keys to move the J point marker to the middle of period (4) joining the S and T periods. Setting the ST measuring point Select J +40, J +60 or J +80 to set the ST measuring point. Select X to exit the window. 11.7.5 ST Analysis Review The monitor can save up to 20 groups of ST measurements.
Page 73: Arrhythmia Analysis
11.8 Arrhythmia Analysis Arrhythmias are abnormal rhythms of the heart which are generated outside the normal conductive pathway, they usually present themselves as an abnormal rate or with abnormal morphology. These disturbances can be intermittent or benign and if left untreated could be lethal to the patient. The monitor uses user selectable leads for the arrhythmia analysis and will display status messages according to the detected waveform. During the analysis, the monitor: •...
Page 74: Arr Relearning
11.8.5 ARR Relearning Arrhythmias are patient specific and this functionality relies on the system making a comparison of the patient’s ECG with that of a stored template which the system “learns” during an initialisation period. To ensure optimum performance, the ARR relearn should be initiated before any arrhythmia monitoring. This only needs to be carried out at the beginning of the monitoring session or if there has been a significant change in the appearance of the ECG complex.
Page 75: Respiration Monitoring
12. Respiration Monitoring 12.1 Respiration Measurement The Monitor measures RESP based on the trans-thoracic impedance method. It detects impedance changes between two electrodes. The impedance changes generate a RESP wave on the screen, the RR is calculated from this wave. 12.2 Placement of Electrodes Refer to the ECG section for details on patient preparation and electrode placement.
Page 76: Respiration Setup
12.4 Respiration Setup 12.4.1 Changing the size of the Respiration wave The gain setting is used to adjust the amplitude of the respiration wave, select a gain setting to maximise the waveform on the display. Select the Resp parameter area to enter [Resp Setup] and select [Gain], [x0.25], [x0.5], [x1], [x2] or [x4]. 12.4.2 Apnoea Alarm Delay WARNING The Apnoea alarm does not recognise obstructive or mixed apnoea, it indicates an alarm...
Page 77: Spo Monitoring
It is useful for the clinician to know the wavelength range and maximum optical output power of the sensor for the purpose of photodynamic therapy. ◊ The Huntleigh SpO2 sensor uses a wavelength of 660nm (red LED) and 905nm (IR LED). ◊ The Nellcor SpO2 sensor uses a wavelength of 660nm (red LED) and 900nm (IR LED).
Page 78: Safety
13.2 Safety WARNING The monitor is only compatible with SpO2 sensors approved by Huntleigh. Before monitoring the patient, please check if the sensor and extension cord are compatible with the Monitor. Incompatible accessories may reduce the performance of the Monitor.
Page 79: Accuracy Verification
13.3.2 PR Accuracy The accuracy of the SpO2 PR can be verified by comparing it with the patient’s heart rate derived from the ECG. 13.4 SpO2 Waveform (Huntleigh) The Pleth Wave is automatically scaled to fit the space on the screen. It is not proportional to the pulse volume or signal quality. The Perfusion Index has a range 0.05% to 20%, the higher the value, the better the perfusion. The SQI represents signal quality, the higher the vertical bar the better the quality of the signal.
Page 80: Sweep Speed
13.5.1 Sweep speed Select the waveform area to display the Pleth Wave set up options, select [SWEEP], [6.25mm/s], [12.5mm/s], [25mm/s], or [50mm/s]. Make selection and press to confirm selection. 13.5.2 Signal IQ The SpO2 measurement is supported by a signal quality indicator, this can be enabled or disabled as required.
Page 81: Sensitivity
13.5.4 Sensitivity In situations where there may be periods of high motion and movement, the SpO2 function is capable of applying different levels of sensitivity – Low, Medium and High to signal detection. Select the waveform area or the SpO2 parameter to display the set up options, select [SpO2 setup], [Sensitivity], select [High], [Med] or [Low]. Make selection and press to confirm.
Page 82: Spo2 Waveform (Nellcor Oximax)
13.6 SpO2 Waveform (Nellcor Oximax) The Pleth Wave is automatically scaled to fit the space on the screen. It is not proportional to the pulse volume or signal quality. The SAT Second timer displays the SAT Second setting. Saturation SAT Second Pleth Wave Measurement timer Pleth Bar Technology Alarm limits 13.7 SpO2 Setup (Nellcor Oximax) Setting up the Nellcor Oximax SpO2 measurements is almost identical to those steps described in the previous sections, however, the Oximax option includes a proprietary SAT Second alarm management feature.
Page 83: Monitoring Steps
Example 3 SpO2 • SAT Second alarm set to 25s. EVENT • Low SpO2 level set to 92% Scenario: The patient’s SpO2 drops to 82% for a time duration of 5s before the saturation returns above the low alarm limit of 92%. E.g. Alarm Calculation: 10% drop x 5 Seconds = 50 SAT Seconds 2.5 seconds Because the SAT Second alarm is set to 25s, an alarm Alarm 25 SAT...
Page 84: Nibp Monitoring
14. NIBP Monitoring 14.1 Overview The SC1200/SC1500 NIBP is intended to give a medical indication of Systolic, Diastolic, Mean Arterial blood pressure and pulse rate for Adult, Neonatal and Paediatric patients, for the detection of high blood pressure. The SC1200/1500 Automated Sphygmomanometer is NOT intended for use with pregnant, including pre- eclamptic patients.
Page 85: Nibp Connections
IBP2 NIBP For the safety of patients, and to ensure the best product performance and accuracy, use only the cuffs and the hose provided with the monitor or recommended by Huntleigh Healthcare Ltd. Measure the patient’s limb and select the proper size cuff. As a general rule, the cuff should encompass at least 80% of the limb circumference. Connect the hose to the NIBP Hose connector as shown. Push until you hear a click.
Page 86: Nibp Cuff Selection And Application
14.3.1 NiBP Cuff selection and application WARNING Use of an incorrectly sized cuff or a misaligned cuff may result in errors in the BP measurement. NOTE The following instructions apply to upper arm measurements, the same precautions should be adopted if other sites are being used. Follow the application instructions for use to ensure the correct size of cuff for the patient. Failure to do so will adversely affect the accuracy of the measurement.
Page 87: Nibp Display
14.3.3 NIBP Display The NIBP measurements are displayed in the parameter area. The figure below is for reference only. The actual display interface of the Monitor may be slightly different from this figure. Accessing the NiBP display will enable the NiBP setup options. Time of the measurement Alarm limit Measurement mode: auto, manual or Systolic pressure continual Patient type: ADU, PED or NEO. Diastolic pressure Mean pressure (in the measurement process, Pressure unit: mmhg or kPa displays the cuff pressure) 14.4 NIBP Setup...
Page 88: Patient Type
14.4.1 Patient Type The PATIENT TYPE setting is set during the PATIENT ADMIT process. Check the correct patient type appears in the NiBP parameter area. Failure to set the correct patient group will deliver incorrect measurements. 14.4.2 Measurement Modes The monitor is capable of delivering three types of NiBP measurement: •...
Page 89: Target Pressure
14.4.3 Target Pressure The TARGET PRESSURE is patient group specific, the following default settings are applied: • Adult 160 mmHg (range 80-240 mmHg) • Paediatric 120 mmHg (range 80-200 mmHg) • Neonate 100 mmHg (range 60-120 mmHg) The user can adjust the initial cuff target pressure, press the NiBP parameter to display the set up options, press [Target Pressure], use the keys to set the desired setting. Press to save and exit. 14.4.4 Alarm Limit Setup Alarm limits can be applied to the SYSTOLIC, DIASTOLIC and MAP measurements.
Page 90: Stat Measurements
14.4.5 STAT measurements See section 14.4.2.3 14.4.6 Reset Module In the unlikely event that the NiBP module ‘locks up’ pressing the RESET key resets the module and re- established communication with the host. 14.4.7 Other Setup (EXTENDED Options) An extended set of options are provided by the OTHER SETUP menu, these cover the assisted venous puncture mode and NiBP analysis feature.
Page 91: Venous Puncture Start
14.4.7.2 Venous Puncture Start With the NiBP cuff applied to the correct position, press the NiBP parameter to display the set up options, select [Other Setup], [Venous Puncture Start]. The cuff will automatically inflate to the target pressure and hold it for a set period allowing sufficient time to draw a sample. The Cuff will hold the target pressure for: • Adult 170 seconds • Paediatric 170 seconds • Neonate 85 seconds After which the system automatically deflates the cuff. During the procedure, the NiBP area will display the elapsed time, cuff pressure and target pressure. Patient Group Elapsed Timer ADULT (1:53 s to cuff deflation) Target Pressure Cuff Pressure 80 mmHg...
Page 92: Nibp Analysis
NOTE Performing a venous puncture with the unit set to AUTO mode will suspend the timed measurements for the duration of the venepuncture and a further period of 3 minutes afterwards. 14.4.7.3 NiBP Analysis The NiBP ANALYSIS feature allows you to display and compare the patient’s BP measurements with user definable limits.
Page 93: Dynamic Analysis Trend
Setting Systolic Range To set the SYSTOLIC RANGE, press the NiBP parameter area of the screen to display the NiBP Set up options, use the keys scroll down to [Other setup], select [NiBP Analysis], [Sys Range]. Select [High] and use the keys to set the appropriate level.
Page 94: Start / Stop Manual Bp Measurement
14.5 Start / Stop Manual BP Measurement To start a manual measurement, press the NiBP start / stop soft key or the NiBP start / stop NIBP Start membrane key The cuff will inflate to the target pressure and measure the BP during the controlled deflation of the cuff. The measurement will be displayed: Time of Patient group Pulse Rate measurement ADULT measurement Diastolic Systolic...
Page 95: Temperature Monitoring
15. Temperature Monitoring 15.1 Introduction The SC1200/SC1500 is a direct mode thermometer, providing clinicians with body site temperature measurement. This is the site on the body where the sensor is placed in or on and where the temperature sensor is thermally coupled. The monitor is capable of measuring temperature at two different sites, these are labelled T1 and T2. The system also calculates and displays the difference between both measurements (ΔT).
Page 96: Alarm Settings
15.2.1 Alarm settings WARNING Handle the temperature sensor and cable with caution. When they are not in use, coil them loosely. Tight coiling may cause mechanical damage to the cable. NOTE Do not reuse any disposable temperature sensor. Select the TEMP display, select [Alarm Limit Setup], select [T1], [T2] or [ΔT]. Select the limit to change, use the keys or the touch screen to move the cursor to the new setting.
Page 97: Ibp Monitoring
16. IBP Monitoring 16.1 Introduction Up to four separate IBP channels can be monitored simultaneously: • Option 1 – two IBP channels integrated into the main unit • Option 2 – two extended IBP channels supplied as a plug in module Both options are functionally identical. Option 1 Option 2 IBP1 IBP1 IBP2...
Page 98: Ibp Waveform Speed
To allocate a label, press the IBP waveform area, select [Pressure label], then make selection [ART, PA, CVP, LAP, RAP, ICP, P1, P2, LV, Ao, UAP, BAP, FAP, UVP, IAP, P3 or P4] . Press to save and exit. 16.1.2 IBP Waveform Speed Press the press the IBP waveform area, select [Sweep], then make selection[12.5mm/s or 25mm/s] Press to save and exit.
Page 99: Optimising The Ibp Scales
16.1.4 Optimising the IBP scales NOTE These options are interactive and are linked to the IBP label. To assist with the visualisation of the IBP waveforms, the user can apply background scales to the each waveform: • Upper scale • Middle Scale •...
Page 100: Systolic Pressure Variation - Spv Display
16.1.6 Systolic Pressure Variation - SPV Display SPV is a continuous automatic measurement which requires no user input. Systolic pressure variation (SPV) reflects the effects of respiratory changes in arterial blood pressure during ventilation, it represents the maximum and minimum values of systolic pressure over the measurement period. It is calculated using the following formula: SPV (mmhg) = SBP max – SBP min To switch the measurement ON, press the IBP ART waveform area, scroll down and select [IBP1:ART setup], select [SPV Display], select [ON, OFF]. The SPV measurement will be displayed alongside the IBP numerics.
Page 101: Zero The Pressure Sensor
IBP sensor cable from the sensor interface, and the Monitor will display the prompt message "IBP sensor off" and trigger the alarm sound. NOTE Use the pressure sensor specified by Huntleigh only. NOTE Zero calibration must be performed before monitoring the patient.
Page 102 To prevent inaccurate measurement, zero the sensor on a daily basis or as required by the relevant policies of the hospital. Zero the sensor: • When using a new pressure line or sensor; • When connecting the sensor to the Monitor; or • If you are in any doubt about the measurement accuracy.. Close the three way valve to the patient. The sensor must be open to the atmosphere first.
Page 103: Co Monitoring
17. CO Monitoring 17.1 Overview WARNING If the system fails to measure or respond to the patients breathing pattern, do not use until the situation has been rectified by a qualified person. WARNING Leakage or displacement in the breathing circuit or sampling lines may cause the measurements to be lower than actual measurement, ensure all connections are firm and in accordance with the manufacturer’s instructions.
Page 104: Co Modules
Ins CO2 Value CO2 Waveform Alarm limits awRR Rate 17.2 CO Modules This monitor is compatible with two plug in CO modules specified by Huntleigh. Mainstream CO module Sidestream CO module Fitting the module to the SC1200/SC1500 Main unit CO2 Module SC1200 / SC1500...
Page 105: Sensor Connections
17.3 Sensor Connections 17.3.1 Mainstream Sensor NOTE The sensor must be calibrated before the monitoring session begins or when a new airway adapter is used e.g. switching from reusable to single use adapter. Insert the mainstream module into the expansion slot on the monitor. Connect the interface cable to the module and connect the mainstream sensor to the free end of the interface cable.
Page 106: Sidestream Sensors And Sampling Lines
Typical ZERO time is between 15 and 20 s. Zero calibration must be carried out with the adapter disconnected from the patient circuit. Wait until the zero calibration has been completed and carefully install the assembly at the proximal end of the breathing circuit between the elbow and ventilator Y piece.
Page 107: Measurement Steps
Insert the sidestream module into the expansion module slot on the monitor. Connect the sampling line to the sidestream module, wait 2 minutes for the system to reach operating temperature. Sample Kit Hours of Use Nasal Cannula (all styles) – up to 12 hours. On Airway Adapter Kits without dehumidification tubing – up to 12 hours.
Page 108: O2 Compensation
17.4.2 O2 Compensation WARNING O2 compensation must be set according to the actual conditions, failure to set the correct value may lead to inaccurate measurements. O2 compensation is required to achieve accurate measurements. Select the CO2 parameter area to display the set up options, select [O2 Compensation]. Use the keys to set the compensation value to 16%.
Page 109: Apnoea Delay
17.4.4 Apnoea delay WARNING The Apnoea alarm does not recognise obstructive or mixed apnoea, it indicates an alarm situation when a predefined time has elapsed since the last detected breath. The Apnoea alarm is a high priority red alarm. This determines the time limit after which the monitor sounds an alarm if the patient stops breathing.
Page 110: Alarm Limit Set Up
17.4.7 Alarm limit set up Users can set upper and lower alarm limits to the CO2, Inspired CO2 value or awRR. Press the CO2 parameter area of the screen to display the CO2 Setup menu, scroll down until Alarm Limit Setup option is displayed.
Page 111: Managing Data
18. Managing Data 18.1 Overview The system provides the user with up to 120 hours of stored data, this comprises 5,000 NiBP measurements, 200 alarm events, 100 arrhythmia events and up to 48 hours of waveform storage. This information is patient specific and is collected throughout the monitoring session, it can be displayed in graphical and or tabular formats. All information is stored in the patient database. 18.2 Waveforms NOTE This feature can only be accessed with NO patient admitted onto the system.
Page 112: Waveform Freeze
18.3 Waveform Freeze Users have the ability to FREEZE waveforms on the display. Press the FREEZE soft key to display the main controls. The user has the ability to select different waves e.g. ECG, Resp or Plethysmogram etc. Wave Position 1 Scroll controls Printer controls Use the controls to scroll back and forth the static waves. Press the print key to obtain strip chart print out of selected waveforms.
Page 113: Trend Review
18.4.1 Trend Review Press [Trend Review] to display the trend table, this can be presented in either graphical or tabular format. Graphical format Tabular format Graphical Tabular Report time format format Print Report on integrated recorder Print Report on Resolution adjustment Review controls local printer 1s, 5s, 10s, 1min 5min...
Page 114: Nibp Review
18.4.2 NiBP Review Press [NiBP Review] to display list of NiBP measurements. These will be listed in order with the oldest measurement at the top of the list. 18.4.3 Alarm Event Review WARNING Only current physiological and technical info can be displayed; upon restart of the monitor, the alarm info will be cleared.
Page 115 Press [Alarm Event Review] to display list of Alarm messages. There are two options, PHYSIOLOGICAL and TECHNICAL. Press [View Physiological Alarm] to display the list of physiological alarms Press [View Technical Alarm] to display the list of technical alarms Press to save and exit.
Page 116: Waveform Review
18.4.4 Waveform Review Press [Wave Review] to display the saved waveforms. Patient Name & ID Waveform Review Symbol Explanation Page up and down Waveform gain; select this button to choose the appropriate gain. Waveform identification; select the waveform to be viewed. Start time of waveform view. 2018-10-06 07:50:58 Print waveform. Print waveform via USB printer. Users can print any of the saved waveforms. Examples ECG Wave Review: Before admitting a patient, enter the [Wave Save] interface under [User Maintain]; select the waveform to...
Page 117: Recorder
19. Recorder 19.1 Description of Recorder The optional integrated recorder can print a combination of numerical data as well as up to three user defined physiological waveforms. Fault OPEN OPEN OPEN indicator Open/ close POWER ERROR latch Power indicator Printer door Recorder 19.2 Loading paper To open the recorder, press the latch and pull the door open.
Page 118: Sample Printout
CAUTION To prevent damage to the print head, take care when loading the paper. CAUTION Do not pull on the paper when printing as you may damage the recorder. CAUTION Ensure the recorder door remains shut except for paper change or troubleshooting. Sample Printout User defined waveforms Vital Signs...
Page 119: Manual Operation
Setting the Record Wave (1, 2 or 3) Select [Record Wave 1] and select the relevant waveform, use the keys to scroll the list. Select waveform as necessary. Repeat this process for the remaining settings. Press to save and exit. 19.4 Manual Operation NOTE Recorder and printout can be initiated by several methods - actuation of the dedicated soft key,...
Page 120: External Printing
20. External Printing 20.1 External printer specification NOTE For instructions on the printer, please see the documentation supplied by the manufacturer. The system can output A4 format patient reports via the USB connected printer. The monitor supports the following types of printer: • HP laserJet 1505n monochrome laser printer •...
Page 121: Nibp Report
20.2.1 NiBP report The NiBP report lists all BP measurements that are associated with the patient being monitored. Select [Main Menu], [Ext Printer Setup], [Print Report], [NiBP List]. Set the start and finish times for the report. The user can set a window to look back at the saved measurements.
Page 122: Alarm Event Report
20.2.4 Alarm event report The alarm event report prints a comprehensive list of all alarm events (physiological and technical). The report provides a summary of: • Alarm time • Alarm description • Alarm value (if physiological) • Alarm type (Low medium or high priority status) Select [Main Menu], [Ext Printer Setup], [Print Report], [Alarm Event Report].
Page 123: Graphical Trend Report
20.2.6 Graphical Trend Report The graphical report provides a summary of the physiological parameters associated with the current patient. Select [Main Menu], [Ext Printer Setup], [Print Report], [Graphical Trend Report]. Set the start and finish times for the report. This period can be set to 30mins, 1hr, 2hrs, 3hrs, 6hrs, 12hrs, 24hrs, 48hrs, 72 hrs or 96hr.
Page 124: Extended Functionality
To set the Alarm level (priority), press [Alarm Level] and make the necessary selection [High], [Medium + High] or [Low + Medium + High]. Press X to save the selection and exit. 21.2 Central Monitoring System Interface The system can be connected to a Huntleigh Central Monitoring System via a wired connection. Refer to CMS installation manual for configuration details.
Page 125: Ecg Analogue Output
21.3 ECG Analogue Output In certain situations, auxiliary devices may need to use the ECG signal for certain applications such as ECG synchronisation; to accommodate this, the system provides an analogue ECG output signal via the rear panel multi-function port. Contact the service department for specific details of this connection. This feature is accessed through the ENGINEERING access level which is password protected. Select [Main Menu], [Maintain], enter password, select [Analogue Out], select the relevant lead.
Page 126: Battery
22. Battery 22.1 Introduction WARNING Improper replacement of the lithium battery could result in unacceptable risks. WARNING Battery replacement should be carried out by suitably qualified personnel. WARNING Please keep the battery out of the reach of children. WARNING Battery electrolyte is hazardous. If the battery electrolyte comes into contact with your skin or enters your eyes, please wash with clean water immediately and seek medical attention.
Page 127: Battery Installation
22.2 Battery installation WARNING Only use batteries approved by Huntleigh. WARNING Do not remove the battery if the system is switched ON. Steps for replacement or installation of the battery: Switch off the monitor; disconnect the power cord and all accessories. Place the monitor with its back facing upward, locate the battery compartment. Remove 2 fixing screws...
Page 128: Battery Recycling
2) Check Battery Performance The battery life varies with the storage and operating environments, frequency of battery discharging and operating time. The battery performance will gradually degrade even if the battery is not used. Steps for checking the battery: Determine whether the battery is damaged. When the battery icon shows , it indicates the battery is damaged or there is no battery connected.
Page 129: Cleaning
23. Cleaning Materials and methods listed in this section are recommended by the Company for cleaning and disinfecting the system. Any damage arising from the use of non-recognised materials and methods will not be covered under the terms of the warranty. The Company will not assume liability for the effectiveness of listed chemicals or methods when they are used as infection control means.
Page 130: Cleaning And Disinfecting Bp Cuffs
Follow the instructions provided by the sensor manufacturer. 23.4 Precautions After cleaning check the system, if there is any evidence of damage, do not use. If it is necessary to return the system to Huntleigh for repair, clean the device thoroughly and follow the instruction in the maintenance section: •...
Page 131 Recommended detergents: Item Detergent Disinfectant Display screen Monitor housing Ethanol (75%±5) Ethanol (75%±5) Isopropyl alcohol (70%) Isopropyl alcohol (70%) Power cord ECG patient cable ECG electrodes Single use – dispose after use Alcohol free hand soap, Isopropanol (70%), Sodium hypochlorite (2.5%) SpO2 sensors –...
Page 132: Maintenance
8. Inspect the SC1200/SC1500 membrane keys, jog wheel controls and rubber feet for loose broken or missing parts. 9. If there is damage to the main SC1200/SC1500 unit, contact your local Huntleigh Healthcare Ltd representative. 10. Switch the device on and check that the device operates normally, the alarm self-test is performed at boot up and the device is able to run on its internal battery 11.
Page 133: Technical Specifications
25. Technical Specifications Equipment Classification Type of protection against electric shock. Internally powered equipment Degree of protection against electric Type CF with defib protection - ECG shock (respiration), IBP (P1 - P4) Type BF with defib protection - NiBP, Temp, SpO2, EtCO Mode of operation. Continuous MDD/MDR Classification Class IIb Ingress Protection IPX1 Drip proof Degree of safety of application in the Equipment not suitable for use in the presence of a presence of a flammable anaesthetic...
Page 134 Data Storage Short trends 1hr trend, (1s resolution) Long trends 120hr trend, (1min resolution) Trend capacity 120hr (graphical and tabular) Alarm events 200 events first in first out rolling buffer NIBP measurements 5,000 groups Arrhythmia history 100 arrhythmia events and waveforms (32s duration) Waveforms Up to 2 x 24hr single lead ECG waveforms 3 Lead RA, LA, LL Lead designation...
Page 135 Input signal range ±5mV Pacemaker Detection/Rejection without Amplitude: ±2mV to ± 700mV overshoot. Pulse Width: 0.1ms to 2.0ms HR Calculation If the last 3 RR intervals are greater than 1200ms, the last 4 RR intervals are averaged for the HR calculation. Otherwise the last 12 RR intervals (with the longest and shortest intervals excluded) are averaged for the HR calculation.
Page 136 Display update 2 seconds Signal averaging High -6 Seconds, Medium -12 Seconds, Low - 18 Seconds Accuracy Huntleigh Brand Nellcor Oximax Range 70 to 100%* ±2% (adult / Range 70 to 100%* ±2% (adult / paediatric no motion) paediatric no motion) Range 70 to 100% ±3% (Neonate...
Page 137: Resolution Accuracy
Resolution ±0.1°C Accuracy ±0.2°C Transient response time Pulse Rate Module Range (bpm) Resolution (bpm) Accuracy Huntleigh SpO2 20 – 250 ±1bpm Nellcor SpO2 20 – 300 ±3bpm (25 – 250bpm) Not specified (251 – 300bpm) NIBP 40 – 240 ±3bpm or ±3% (max) Alarm setting range and 1 - 350 ±1...
Page 138 Invasive Blood Pressure Number of Channels 4 (2 internal and 2 channels via optional module) Channel labels ART, PA, CVP, RAP, LAP, ICP, P1, P2 Transducer Type Solid state pressure transducer Input sensitivity 5µV/V/mmHg Measurement Range -40 to 360 mmHg Arterial 0 to 300 mmHg (0 to 40 kPa) Pulmonary artery...
Page 139 Standards EN ISO Medical devices quality management systems 13485:2012+AC:2012 EN ISO 14971:2012 Application of risk management to medical devices EN 60601-1:2006+A1:2013 General requirements for basic safety and essential performance EN 60601-1- General requirements for basic safety and essential performance, collateral 2:2007+AC:2010 standard, EMC requirements and test EN 980:2008...
Page 140: System Alarm Messages
26. System Alarm Messages Each physiological or technical alarm message is listed in this section, the appearance on the monitor will be dependent on the monitor configurations 26.1 Physiological Alarm Messages Source Default Level Range Condition Indication Value exceeded alarm XX too high Medium High, medium, low Yellow alarm limit Value dropped below...
Page 141 SpO2 SpO2 too high High High, medium The measured value is greater than the SpO2 too low High High, medium upper alarm limit or Red alarm PR too high High High, medium, low smaller than the lower alarm limit. PR too low High High, medium, low No pulse...
Page 142: Techniical Alarm Messages
Restart the Monitor to try XX comm stop High communicate with the main again. If the error still exists, system. contact Huntleigh for service The XX module fails to XX comm err High communicate normally with the main system. The alarm limit of parameter...
Page 143 CO2 Temp out of The module has a fault Return to Huntleigh for repair range CO2 is zeroing CO2 analyzer is in calibration None Connect the Monitor to the AC power supply to charge the...
Page 144: System Prompt Messages
26.3 System Prompt Messages System prompt messages do not have an alarm status. They provide feedback to the user of specific conditions. NIBP Alarm Message Manual measure... Auto measuring... Calibrating... Calibrate stopped Leakage testing... Leakage test stopped Resetting... Measure stopped Continual measuring... Over pressure Please start Reset failed Reset for error Venipuncture start Module resetting... Venipuncture stop IBP Alarm Message IBP1 zeroing IBP2 zeroing...
Page 145: Default Configuration
27. Default Configuration The configurations of each department and some important configuration settings are list below. The user is not allowed to alter the configurations, but some settings can be altered and saved as user configurations. 27.1 General Configuration Alarm Item General NICU Alarm volume Alarm recording time Waveform/ parameter colour Item General NICU Green SPO2 Cyan RESP Yellow NIBP White TEMP White Yellow Review Item General NICU Trend graph resolution Trend table resolution 1 min Layout...
Page 146 Event Setup Item General NICU Waveform 1 Waveform 2 Waveform 3 PLETH Record Item General NICU Waveform 1 Waveform 2 Waveform 3 Waveform record output speed 25 mm/s RT record time Timed record interval Grid Maintenance Item General NICU Wave mode Mono Wave Line Thin...
Page 147: Default Alarm Limits
27.2 Default Alarm Limits Item General NICU 50 --- 120 75 --- 160 100 --- 200 SpO2 85 --- 100 50 --- 120 75 --- 160 100 --- 200 90 --- 160 SYS(NIBP) 70 --- 120 0---4 40 --- 90 60 --- 110 MAP(NIBP) 50 --- 90...
Page 148: Default Configuration
Item General NICU Label Scale 0, 150 90, 160 Systolic pressure alarm 70, 120 limit 55, 90 70, 110 Mean pressure 50, 90 alarm limit 35, 70 50, 90 Diastolic pressure alarm 40, 70 limit 20 60 Label CVP, LAP, RAP, ICP, UVP and IAP Setup Scale 0, 40 0, 10...
Page 149: Adult/Ped Alarm Ranges And Default Limits
27.3.2 ADULT/PED Alarm Ranges and Default Limits Alarm Limit Range Arrhythmia Default Step Unit Priority Type From Heart Pause Medium Time Pause/min Medium Extreme Tachycardia Medium Tachycardia Limit +1 Extreme Tachycardia 100 Tachycardia Medium Limit -1 Extreme Bradycardia Bradycardia Medium Limit +1 Extreme Bradycardia...
Page 150: Default Configuration
27.4 Default Configuration Default ECG Settings Item General NICU Cascade Lead name Gain Sweep 25 mm/s Channel format 2x6+1 Filter Mode Monitor Lead type 5 Lead Calculate lead HR Source Alarm Alarm record Alarm level Medium PF inhibition On (50Hz) Smart lead off HR alarm limit Note: refer to Section 28.1 General Configurations for default HR alarm limits...
Page 151 Default SpO2 Settings Item General NICU Sweep 12.5mm/s Sat-Second (Nellcor) Fast Sat Smart tone Signal IQ Alarm Alarm record Alarm level (Nellcor) High SpO2 (90 --- 100) Alm limit (Nellcor) (90 -- 100) SpO2 alarm limit Note: refer to Section 28.1 Default Alarm Limits Default PR Settings Item General NICU...
Page 152 Default Temp Settings Item General NICU Alarm Alarm record Alarm level Medium T1 Alarm 36.0°C - 39.0°C limit T2 Alarm 36.0°C - 39.0°C limit TD Alarm 0.0°C - 2.0°C limit Default CO2 Settings Item General NICU Gain Sweep 6.25mm/s Work mode Measure O2 compensation (Respironics)
Page 153: Electromagnetic Compatibility
28. Electromagnetic Compatibility Make sure the environment in which SC1200/SC1500 is installed is not subject to strong sources of electromagnetic interference (e.g. radio transmitters, mobile phones). This equipment generates and uses radio frequency energy. If not installed and used properly, in strict accordance with the manufacturer’s instructions, it may cause or be subject to interference.
Page 154: Electromagnetic Environment - Guidance
Guidance and Manufacturer’s declaration - electromagnetic immunity The SC1200/SC1500 is intended for use in the electromagnetic environment specified below. The customer or the user of the SC1200/SC1500 should assure that it is used in such an environment. IEC 60601 test Compliance Immunity Test Electromagnetic Environment - guidance level level Portable and mobile RF communications equipment should be used no closer to any part of the SC1200/ SC1500, including cables, than the recommended separation distance calculated from the equation...
Page 155 Guidance and Manufacturer’s declaration - electromagnetic immunity The SC1200/SC1500 intended for use in the electromagnetic environment specified below. The customer or the user of the SC1200/SC1500 should assure that it is used in such an environment. IEC 60601 test Immunity Test Compliance level Electromagnetic Environment - guidance level Electrostatic ± 6 kV contact ±...
Page 156 Recommended separation distances between portable and mobile RF communications equipment and the SC1200/SC1500 The SC1200/SC1500 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the SC1200/SC1500 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SC1200/SC1500 as recommended below, according to the maximum output power of the communications equipment.
Page 157: Toxic/Hazardous Substances/Elements
29. Toxic/Hazardous Substances/Elements Component Cr(V1) PBDE Front Housing Rear housing Housing Keys Facing Labels Display Display Hardware Main Unit Internal wires PCBA Packing Packing materials Connectors General components Power cord Battery Lithium battery SpO2 Accessories Temp NIBP Ο: Such hazardous/toxic substance contained in all homogeneous materials of such component falls within the content limit specified in SJ/T11363-2006. Note ×: Such hazardous/toxic substance contained in one or more homogeneous materials of such component goes beyond the content limit specified in SJ/T11363-2006.
Page 158: End Of Life Disposal
30. End of Life Disposal 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.
Page 159: Warranty & Service
31. Warranty & Service Huntleigh Healthcare Diagnostic Products Division standard terms and conditions apply to all sales. A copy is available on request. These contain full details of warranty terms and do not limit the statutory rights of the consumer.
Page 160: Appendix A Accessories
Appendix A Accessories This section lists the approved accessories for use with the SC1200/SC1500. These items can be sourced through your supplier or directly with HUNTLEIGH. WARNING To maintain system integrity and performance, only use HUNTLEIGH approved items. WARNING Never re-use single use items, reuse may compromise device functionality and patient safety.
Page 161 SpO2 Sensors (Huntleigh technology) Order Code Description Location Weight Pack size ACC VSM 289 Adult Reusable SpO2 Finger sensor, 10ft Finger clip >30kg ACC VSM 290 SpO2 Extension Cable, 8ft ACC VSM 291 Adult Reusable SpO2 Finger sensor, 3ft Finger clip >30kg...
Page 162 IBP sampling lines and Interface cables Order Code Description Pack size ACC VSM 328 IBP Interface cable with Abbott connector ACC VSM 329 Disposable pressure transducer kit (Abbott) ACC VSM 330 IBP interface cable with B&D connector ACC VSM 331 Disposable pressure transducer kit (BD) ACC VSM 332 IBP interface cable with Braun connector...
Page 163: Appendix B Clinical Evaluation
Appendix B Clinical Evaluation SPO2 Summary Report SpO2 Test model: Huntleigh Blood Oxygen Saturation Module (27 subjects) Third Party Blood Oxygen Saturation Module (27 subjects) Nellcor Blood Oxygen Saturation Module (26 subjects) Clinical subjects: Test subjects; 60 adults and paediatrics and 20 infants and newborn subjects participated in this trial. The adults and paediatrics varied in age from 3 to 76 years old (mean 43.7). The infants and newborn varied in age from 0.25 to 730 days (mean 170.8).
Page 164: Co2 Summary Report
CO2 Summary Report Technology: Respironics side stream CO2 Test method used to determine the rated respiration rate range: each breathing cycle calculated from the CO2 waveform is considered a respiration. The respirations per minute is the Airway respiration rate (AWRR). Clinical trial of EtCO2 Test subjects; 60 adults and paediatrics and 20 infants and newborn subjects participated in this trial. The adults and paediatrics varied in age from 3 to 76 years old (mean 43.7). The infants and newborn varied in age from 0.25 to 730 days (mean 170.8).
Page 165: Appendix C Co2 Loflo Interfering Gasses Vapours
Appendix C CO2 LoFlo interfering gasses vapours B. ISO 80601-2-55: Table 201.105 – Test gas levels of interfering gases and vapours Gas or Vapor Level Quantitative Effects Nitrous oxide 60% No Additional Effect Halothane 4% No Additional Effect Enflurane 5% No Additional Effect Isoflurane 5% No Additional Effect Sevoflurane 5% No Additional Effect Xenon Negatively bias Carbon Dioxide values by up to an additional 5 mmHg at 38 mmHg Helium 50% No Additional Effect...
Page 166 In the European Union, the user should also report the serious incident to the Competent Authority in the member state where they are located. Manufactured in the UK by Huntleigh Healthcare Ltd on behalf of; ArjoHuntleigh AB Hans Michelsensgatan 10 211 20 Malmö, Sweden...

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