Huntleigh SC300 Instructions For Use Manual
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Huntleigh SC300 Instructions For Use Manual

Spot check vital signs monitor
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SC300
Spot Check Vital
Signs Monitor

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Summary of Contents for Huntleigh SC300

  • Page 1 SC300 Spot Check Vital Signs Monitor...
  • Page 2 The information contained in this document is subject to change without notice. Huntleigh Healthcare Ltd makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fi tness for a particular purpose.

  • Page 3: Table Of Contents

    Contents 1. General Safety Information ..........5 1.1 Warnings / Cautions ..................... 5 2. Introduction ................8 Features of the Smartsigns ® Compact 300 ............ 8 Intended Use ....................9 About This Manual ..................9 3. Description of Controls, Indicators,Symbols and Displays ................10 Identifi...
  • Page 4 11. Temperature Monitoring ...........40 11.1 Description of the Thermometer IRT10 ............40 11.2 Thermometer Display ..................41 11.3 Main Unit Display ................... 41 11.4 Pairing the Thermometer and Main Unit ............42 11.5 Temp Measurement ..................42 12. Maintenance ..............43 12.1 General ......................

  • Page 5: General Safety Information

    General Safety Information This section contains important safety information related to general use of the Smartsigns Compact 300 vital signs monitor. Other important safety information appears ® throughout the manual Important! Before using this equipment, please study this manual carefully and familiarise yourself with the controls, display features and operating techniques.
  • Page 6 WARNING: If the battery shows any signs of damage, leakage, or cracking, it must be replaced immediately, by a qualifi ed service person, and only with a battery approved by the manufacturer. WARNING: The monitor is intended only as an adjunct in patient assessment.
  • Page 7 Anyone who connects additional equipment to the signal input or signal output port confi gures a medical system and is therefore responsible that the system complies with the requirements of IEC60601-1-1 and the electromagnetic compatibility standard IEC60601- 1-2. If in doubt, contact Huntleigh Healthcare Service Department.

  • Page 8: Introduction

    The monitor is powered either by the local mains supply (100 – 240 VAC 50/60Hz) or an internal 2200 mAh lithium Ion battery. The internal batteries are charged whenever the SC300 is connected to the local supply. Display The monitor uses a 6” LED type of numerical display to display patient and system status.

  • Page 9: Intended Use

    Intended Use The Smartsigns Compact 300 Series is intended for use by trained healthcare professional in healthcare settings to monitor physiologic status of Adult, Paediatric and Neonatal patients. Physiologic measurements include: • Non invasive blood pressure (NiBP) • Pulse oximetry •...

  • Page 10: Description Of Controls, Indicators,Symbols And Displays

    Description of Controls, Indicators, Symbols and Displays Identifi cation of Front Panel Controls and Symbols Carry handle Display ON / OFF Battery Indicator • ON: Battery is being charged, or fully charged • OFF: Battery is not fi tted or faulty •...

  • Page 11: Identifi Cation Of Rear Panel Controls

    Identifi cation of rear panel controls Loudspeaker Equipotential post RS232 Service port AC Power connector Product identifi cation label Identifi cation of Side panel controls Left Right Wireless Infra red thermometer NiBP connector IRT10 (option) SpO2 connector Thermometer lens (option)

  • Page 12: Identifi Cation Of Underside

    Identifi cation of Underside Battery compartment Adaptor plate fi xing point The internal battery is accessed through the compartment located on the underside of the unit. A fi xing kit is available for the unit. It is attached using a single point fi...
  • Page 13 Symbols Description Battery charging indicator lamp AC power(AC) Input/output Refer to instructions for use IPX1 Protection against vertically falling water drops Serial number (Date of manufacture is included in SN) This symbol signifi es that this product complies with the essential requirements of the Medical Devices Directive 93/42/EEC as amended by 2007/47/EC This symbol signifi...

  • Page 14: Description Of Controls

    Description of Controls Description Controls ON/OFF/STANDBY Key • Press this button to start the system – the system status indicator will illuminate green. • When in measurement mode, press this button to enter standby mode – the system indicator changes to amber. •...

  • Page 15: Setting Up The Monitor

    Setting up the Monitor WARNING: The Smartsigns Compact 300 is a prescription device and is to ® be operated by qualifi ed personnel only. It is designed for use by medical clinicians. Although this document might illustrate medical monitoring techniques, the monitor must be used only by trained clinicians who know how to take and interpret a patient’s vital signs.

  • Page 16: Unpacking And Inspection

    Compact 300 vital signs monitor is shipped in one carton. Examine ® the carton carefully for evidence of damage. Contact Huntleigh Healthcare Ltd Service Department immediately if any damage is discovered. Return all packing material and monitor. Refer to the Maintenance section for instructions on returning damaged items.

  • Page 17: Power Cable Connections

    WARNING: In the USA, do not connect to an electrical outlet controlled by a wall switch because the device may be accidentally turned off. CAUTION: For the safety of patients, use only a Huntleigh Healthcare Ltd supplied power cord. Using a non approved power cord can damage the monitor, and will void the product warranty.

  • Page 18: Connecting Accessories

    Smartsigns Compact 300 only, or accessories recommended by ® Huntleigh Healthcare Ltd Service Department. NIBP Hoses and Cuffs NIBP Hose Connector Select the appropriate size cuff for the patient and apply the cuff to the selected site.
  • Page 19 Wireless thermometer (Option) Status indicator Start measurement Display Infra red sensor Lens ejector Battery compartment...

  • Page 20: Battery Operation

    Battery Operation WARNING: Dispose of Battery in accordance with local requirements and regulation. Follow local instructions regarding disposal or recycling of batteries. CAUTION: If the Smartsigns Compact 300 is to be stored for a period ® of 2 months or longer, it is recommended to notify service personnel to remove the battery from the monitor prior to storage.

  • Page 21: Operating On Battery Power

    Operating on Battery Power With NiBP measurements taken at 15 minute intervals, the operating time for a fully charged battery pack is nominally 12 hours. When connected to the AC power supply, the battery is automatically charged. The battery icon shown on the screen will indicate the battery status: Battery indicator Status Battery is fully charged...

  • Page 22: System Display

    System Display The display is organised into a series of zones...
  • Page 23 Item Description System time Set the time - Year, Month, Date, Hour, Minute Patient measurement data review 50 sets data can be stored in the monitor NIBP measurement units mmHg or kPa. MAP - Mean arterial blood pressure reading Pulse rate – derived from NiBP measurement SpO2 sensor status: Own brand SpO2: •...

  • Page 24: Using The Monitor

    Using the Monitor WARNING: If the POST (power on self-test) is not completed successfully, do not use the monitor. WARNING: Ensure that the speaker is clear of any obstructions. Failure to do so could result in an inaudible alarm tone. WARNING: Disconnect the monitor and sensors/cables during magnetic resonance imaging (MRI) scanning.

  • Page 25: Performing Power On And Self-Test (Post)

    CAUTION: If any indicator or display element does not light, or the speaker does not sound, do not use the monitor. Contact qualifi ed service personnel or Huntleigh Healthcare Ltd Service Department. Turn the monitor ON by pressing the ON/OFF/STAND BY button.

  • Page 26: System Settings

    System Settings The Smartsigns Compact 300 Series provides multiple working modes for its users • Measurement mode – Take measurements • Review mode – View saved measurements • Parameter setting mode – Set pulse tone ON or OFF • Maintenance mode – Adjust system settings •...

  • Page 27: Pulse Tone Setting

    Pulse Tone Setting In the measuring mode, press and hold for 4s to enter the pulse tone setting. The PR value will fl ash Press to switch pulse sound on or off. Press to save the setting and return to the measurement mode. Standby Mode Press to enter the standby mode.

  • Page 28: Maintenance Mode

    Maintenance Mode The maintenance mode is intended for use of a biomedical technician or suitably qualifi ed person. It is unlikely that healthcare professionals or clinicians would need to access this mode. To enter the maintenance mode, press the key within 10s of switching the system The system will display the fi...
  • Page 29 System Date & Time Setting Enter the maintenance mode; Year Press twice to enter the ” year” setting area; Press to increase the value Press to decrease the value Month/Day Press to enter the ”Month” setting Press to increase the value Press to decrease the value Press...
  • Page 30 Brightness Adjust This adjustment is reserved for service personnel Enter the maintenance mode Press repeatedly until the brightness adjustment setting begins to fl ash. Press to adjust the display brightness – 05 being maximum brightness. Restoring Factory Default settings This adjustment is reserved for service personnel Enter the maintenance mode;...

  • Page 31: Nibp Monitoring

    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 Service Department. Using other cuffs or hoses may result in inaccuracies.

  • Page 32: General

    This equipment is suitable for use in the presence of electrosurgery Setup Connections NIBP Hose Connector 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 Service Department.
  • Page 33 Measure the patient’s limb and select the proper size cuff. As a general rule, cuff width should span approximately two-thirds of the distance between the patient’s elbow and shoulder. Connect the hose to the bottom of left corner of the monitor as shown. Push until you hear a click, indicating that the connection is secure.

  • Page 34: Starting / Stopping Measurements

    9.3 Starting / Stopping Measurements Press the key on the monitor’s front panel to initiate a measurement. As soon as the measurement has started, the MAP area of the display will show the cuff pressure. The system will infl ate the cuff to the appropriate default target pressure. The default target pressure of this monitor is: •...
  • Page 35 When the timer reaches 00:00, the next measurement begins automatically. The SC300 will remain in this mode until the user forces a STOP or switches the unit OFF. Stopping the AUTOMATIC NiBP Measurement PRESS and HOLD the NIBP START / STOP button to stop the automatic interval.

  • Page 36: Spo2/Pulse Rate Monitoring

    10. SpO2/Pulse Rate Monitoring Tissue damage can be caused by incorrect application or use of an SpO sensor, for example by wrapping the sensor too tightly or by applying supplemental tape. Inspect the sensor site as directed in the sensor directions for use to ensure skin integrity and correct positioning and adhesion of the sensor.

  • Page 37: General Principles Of Measuring Spo Plethysmography Parameter

    Refer to sensor directions for use. To ensure the best product performance and accuracy, use only Huntleigh Healthcare Ltd provided SpO sensors for SpO measurements.

  • Page 38: Identifying The Spo Module

    10.2 Identifying the SpO Module To identify which SpO2 module is incorporated into your product, refer to the identifi cation on the side of the unit: Own brand SpO2 module NIBP Nellcor Oximax SpO2 Nellcor NIBP NOTE: The SpO2 sensors are NOT interchangeable between the different techn ologies.

  • Page 39: Spo2 And Pulse Rate Display

    10.4 SpO2 and Pulse Rate Display SpO2 (Arterial oxygen saturation): The percentage of oxyhaemoglobin to total haemoglobin. Bar graph: Relative strength of the pulse. PR - Pulse rate: Pulse or heart rate derived from SpO2 signal source. PR symbol: Heart beat...

  • Page 40: Temperature Monitoring

    11. Temperature Monitoring The calibration of the Thermometer should be checked at least once every two years. Use only specifi ed protective lens covers The protective lens cover is single-use. Repeated use might give rise to cross infection. The protective lens cover must be used when measuring, if not, it might cause cross infection or inaccurate readings.

  • Page 41: Thermometer Display

    11.2 Thermometer Display Function / Display Battery status Lens fi lter status Wireless status Scale ºC or ºF Measurement 11.3 Main Unit Display Function / Display Temperature logo Scale ºC or ºF Measurement Wireless status...

  • Page 42: Pairing The Thermometer And Main Unit

    11.4 Pairing the Thermometer and Main Unit Make sure the main unit and ear thermometer are both switched OFF. Press and hold the “ejector key” on the thermometer and switch it ON. The thermometer display will alternate between ºC and ºF and then display “SE”. When “SE”...

  • Page 43: Maintenance

    Huntleigh Healthcare Ltd Service Department. If the institution’s service personnel cannot correct problems, the Smartsigns Compact ® 300 should be returned to Huntleigh Healthcare Ltd for service. Contact Huntleigh Healthcare Ltd Service Department for return instructions. 12.4 Periodic Safety Checks It is recommended that the following checks be performed every 24 months.

  • Page 44: Cleaning

    12.5 Cleaning For surface-cleaning, follow your institution’s procedures or: • The Smartsigns Compact 300 may be surface-cleaned by using a soft cloth ® dampened with either a commercial or nonabrasive cleaner, and lightly wiping the top, bottom, and front surfaces of the monitor lightly. For sensors and probes follow cleaning, disinfecting and/or sterilizing instructions in the directions for use shipped with those components.

  • Page 45: Troubleshooting

    13. Troubleshooting WARNING: If you are uncertain about the accuracy of any measurement, check the patient’s vital signs by alternate means; then make sure the monitor is functioning correctly. WARNING: Only qualifi ed service personnel should remove the cover. There are no user-serviceable parts inside. CAUTION: Do not spray, pour, or spill any liquid on the Smartsigns ®...
  • Page 46 Code Description Cause Solution The pressure is not Check the connection or use a new Air pressure Err stable, such as hose cuff. If the problem persists, contact entanglement service personnel. Check the patient type setting and the The cuff is loose or NIBP weak signal connection or replace a cuff.
  • Page 47 Serviceable error codes and other error codes are listed in the Smartsigns® Compact 300 service manual. If the monitor continues to present an error code, call the Huntleigh Healthcare Ltd technical representative and report the error code number. You will be advised of the remedial action to be taken.

  • Page 48: Corrective Action

    If you experience a problem while using the Smartsigns Compact 300 and are unable ® to correct it, contact qualifi ed service personnel or Huntleigh Healthcare Ltd Service Department. The Smartsigns Compact 300 service manual, which is for user by qualifi ed service ®...

  • Page 49: Electromagnetic Compatibility

    14. Electromagnetic Compatibility Make sure the environment in which Smartsigns® Compact 300 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 50 Guidance and Manufacturer’s declaration - electromagnetic immunity The Smartsigns® Compact 300 is intended for use in the electromagnetic environment specifi ed below. The customer or the user of the Smartsigns® Compact 300 should assure that it is used in such an environment. Immunity Compliance IEC 60601 test level...
  • Page 51 Guidance and Manufacturer’s declaration - electromagnetic immunity The Smartsigns® Compact 300 intended for use in the electromagnetic environment specifi ed below. The customer or the user of the Smartsigns® Compact 300 should assure that it is used in such an environment. IEC 60601 test Compliance Electromagnetic Environment -...
  • Page 52 Recommended separation distances between portable and mobile RF communications equipment and the Smartsigns® Compact 300 The Smartsigns® Compact 300 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. the customer or user of the Smartsigns® Compact 300 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Smartsigns®...

  • Page 53: Specifi Cations

    15. Specifi cations 15.1 Equipment Classifi cation Type of protection against Class 1 with internal power electric shock. Degree of protection against electric shock Mode of operation. Continuous Degree of protection against IPX1 harmful ingress of particles and/or water. Degree of safety of Equipment not suitable for use in the presence of a application in the presence of FLAMMABLE ANAESTHETIC MIXTURE WITH AIR,...

  • Page 54: Electrical

    15.4 Electrical AC Power Voltage 100-240 VAC Frequency 50Hz/60Hz Rated Input power 35VA Battery Type 2200 mAh, 11.1V Lithium Ion When monitor is OFF, the charging time will be no longer than 3 hours Charging Time When monitor is ON, the charging time will be no longer than 5.5 hours.

  • Page 55: Measurement Parameters

    15.6 Measurement Parameters NIBP Measurement method Oscillometric Systolic pressure, diastolic blood, mean pressure and Parameter display pulse systolic pressure 40-270mmHg (5.3-36kPa) Range of measurement for diastolic pressure 10-215mmHg (1.3-28.7kPa) adult mean pressure 20-235mmHg (2.7-31.3kPa) systolic pressure 40-200mmHg (5.3-26.7kPa) Range of measurement for diastolic pressure 10-150mmHg (1.3-20kPa) child...
  • Page 56 Temperature Probe Type Tympanic Infrared Range 34° C to 42.2° C (93.2° F to 108°F) 35° C to 42° C : ±0.2° C (±0.4° F) Accuracy Other range : ±0.3° C (±0.5° F) Resolution 0.1°C (0.1° F) Standards ASTM E1112-00:2000, EN12470-3 and EN12470-4 Pulse Rate Range and accuracy Own Brand...

  • Page 57: Accessories

    16. Accessories Please use accessory models designated by the manufacturer. Using accessories of other models may cause damage to this monitor Disposable accessories can be used only once; their repeated using may result in performance deterioration or cross infection Check the accessories and their packages for any signs of damage. Do not use them if any damage is observed Disposing of single use accessories shall be handled in accordance with the local protocol after use.
  • Page 58 Temperature Lens fi lter 200 pcs (10 boxes) ACC VSM 293 Lens fi lter 800 pcs (40 boxes) ACC VSM 286 Lens fi lter 8,000 pcs (400 boxes) ACC VSM 287 Hardware Mobile stand ACC VSM 153 Wall mount ACC VSM 157 Utility hook ACC VSM 187 Utility basket...

  • Page 59: End Of Life Disposal

    17. End of Life Disposal This symbol signifi es 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 60: Warranty & Service

    Mark the package ‘Service Department ‘ For further details, refer to NHS document HSG(93)26 (UK only). Huntleigh Diagnostics reserve the right to return product that does not contain a decontamination certifi cate. A service manual is available for the Smartsigns series.
  • Page 61 93/42/EEC as amended by 2007/47/EC and has been subject to the conformity assurance procedures laid down by the Council Directive. Manufactured in the UK by Huntleigh Healthcare Ltd. As part of the ongoing development programme the company reserves the right to modify specifi...
  • Page 62 Huntleigh Healthcare Ltd. 35 Portmanmoor Road, Cardiff, CF24 5HN, United Kingdom T: +44 (0)29 20485885 F: +44 (0)29 20492520 sales@huntleigh-diagnostics.co.uk www.huntleigh-diagnostics.com Registered No: 942245 England & Wales. Registered Office: ArjoHuntleigh House, Houghton Hall Business Park, Houghton Regis, Bedfordshire, LU5 5XF ©Huntleigh Healthcare Limited 2017...

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