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Huntleigh Smartsigns Liteplus Скачать руководство пользователя страница 84

84

Item

Compliant with

General Safety

IEC60529 Degree of protection provided by enclosures
water ingress testing (IPX2)

EN ISO14155-1:2003 Clinical Investigation of Medical Devices for Human
Subjects-part 1: General Requirement

AAMI HE48:1993 Human factors engineering guidelines and preferred
practices for the design of medical devices

IEC60601-2-49:2001 - Particular requirements for the safety of
Multifunction patient monitoring equipment

IEC60601-1-1:2000 Collateral standard for medical electrical systems

IEC60601-1-4:2000 Collateral standard for Programable medical systems

IEC60601-1-6:2004 Collateral standard for Usability

ISO14971:2000+A1:2003
Application of risk management to Medical devices

ISO10993-1:2003 Biological evaluation of medical devices-Part 1:
Evaluation and testing

Alarms

IEC60601-1-8:2003 Alarm systems requirements, tests and guidances in
medical electrical equipments systems

Non-invasive
blood pressure

AAMI SP10:2002+A1:2003
Electronic or Automated Sphygmomanometers

EN1060-1:1995 Non-invasive sphygmomanometers

EN1060-3:1997 Supplementary requirements for electrical-mechanical
blood pressure measuring systems

EN1060-4:2004
Non-invasive sphygmomanometers - Test procedures to determine the
overall system accuracy of automated non-invasive sphygmomanometers
IEC60601-2-30:1999
Particular requirements for the Safety, including essential performance, of
automatic cycling indirect blood pressure monitoring equipment

Oxygen saturation

ISO9919:2005 Pulse oximeters, Particular requirements

Temperature
monitoring

ASTM E1112-00:2000 - Electronic thermometer for intermittent
determination of patient temperature
EN12470-3 Clinical thermometers - Part 3: Performance of compact
electrical thermometers (non predictive/predictive) with maximum device
EN12470-4 Clinical thermometers - Part 4: Performance of electrical
thermometers for continuous measurement

Electromagnetic
Compatibility

IEC 60601-1, sub clause 36, and IEC60601-1-2:2001+ A1:2004
Electromagnetic compatibility-requirements & test

IEC61000-3-2:2005 Harmonic Emission

Speci

fi ca

tions

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Содержание Smartsigns Liteplus

Страница 1: ......

Страница 2: ...anties or merchantability and fitness for a particular purpose Huntleigh Healthcare Ltd shall not be liable for errors contained herein or for incidental or consequential damages in connection with th...

Страница 3: ...y Operation 22 5 1 Operating on Battery Power 22 5 2 Charging a Low Battery 23 5 3 Low Battery Indication 23 6 Using the Monitor 24 6 1 Turning on the Monitor 24 6 2 Performing Power On and Self Test...

Страница 4: ...70 13 1 Overview 70 13 2 Cable Connection 70 13 3 Nurse Call Interface 71 14 Maintenance 72 14 1 General 72 14 2 Returning the Smartsigns Liteplus and System Components 72 14 3 Service 72 14 4 Period...

Страница 5: ...re the system shuts down as monitor settings may be lost WARNING As with any medical equipment carefully route patient cabling to reduce the possibility of patient entanglement or strangulation WARNIN...

Страница 6: ...rce may result in disruption of performance WARNING To ensure patient safety do not place the monitor in any position that might cause it to fall on the patient WARNING Disconnect the monitor and sens...

Страница 7: ...fluids on the monitor In case of fluid spilling on the monitor disconnect power cord wipe clean immediately and have the monitor serviced to ensure that no hazard exists CAUTION The monitor may displa...

Страница 8: ...information about each configuration All information in this manual including the illustrations are based on a monitor configured with the NIBP Temperature SpO2 and Printer options If your monitor con...

Страница 9: ...gicenters and sub acutecenters Note Intra hospital transport includes transport of a patient within the hospital or hospital type facility Note The medically skilled and trained user can be clinicians...

Страница 10: ...Down Selection Button 6 MAP Mean Arterial Pressure Display 20 Alarm silence button 7 Print Setting Indicators 21 NIBP start stop button 8 Print Button 22 Temperature Unit Mode Indicators 9 Alarm Butt...

Страница 11: ...s 1 Handle 4 Equipotential Ground 2 Air Ventilator 5 Battery Cover Replacement 3 AC Power Connector 6 Battery Label 7 RS 232 Data Interface Figure 2 Rear Panel Components and Symbols 3 4 5 6 7 1 2 Des...

Страница 12: ...r is lit when the user select the Review button to see the patient history Auto Indicator is on whenever NIBP automatic timed cycles are enabled Charging AC in Indicator is on whenever AC power is pre...

Страница 13: ...re in degrees Fahrenheit Temperature in degrees Celsius is configured to display temperature in degrees Celsius Temperature in Monitor mode is configured to take temperature in the monitor mode This i...

Страница 14: ...is flashing when it is selected to set the date in configuration mode Manual Print Indicator is on when the print setting is set to Manual Print Stream Print Indicator is on when the print setting is...

Страница 15: ...UL60601 1 CAN CSA C22 2 No 601 1 UL Mark IPX2 Dust and Water Resistance REF Reference Number SN Serial Number 500 1060 hPa Environmental shipping storage temperature limitations 50 C o 20 C o Fragile...

Страница 16: ...ly while the button is held in Print Button Option sends the data to the printer and prints current onscreen readings if a printer is installed in the monitor Pressing the Print button during print ou...

Страница 17: ...vent device failure do not subject the monitor to extreme moisture such as direct exposure to rain Such exposure may cause inaccurate performance or device failure WARNING Do not use the Smartsigns Li...

Страница 18: ...int is at any point within the base of a cone by an angle of 30 to the centre of the monitoring display 4 2 List of Components Quantity Item 1 Smartsigns Liteplus Vital signs monitor 1 NIBP Cuff adult...

Страница 19: ...he specified voltage and frequency 100 240 VAC 50 60 Hz Figure 3 AC Power Connection 1 Connect the female connector end of the AC power cord to the monitor rear panel connector 2 Plug the male connect...

Страница 20: ...ect the hose to the right panel NIBP connector see Figure 4 Note For the safety of patients and to ensure the best product performance and accuracy use only a cuff and a hose provided with the Smartsi...

Страница 21: ...el Note For the safety of patients and to ensure the best product performance and accuracy use only Huntleigh Healthcare Ltd provided temperature probes see Figure 6 Note The temperature probes are av...

Страница 22: ...ce when not in use This will ensure a fully charged battery whenever it is needed Note As the battery is used and recharged over a period of time the amount of time between the onset of the low batter...

Страница 23: ...arge a low or dead battery see Setting up the Monitor section Note A full charge of a depleted Ni MH battery takes approximately 8 hours while the monitor is turned off 5 3 Low Battery Indication The...

Страница 24: ...inicians Although this document might illustrate medical monitoring techniques the monitor must be used only by trained clinicians who know how to take and interpret a patient s vital signs WARNING Ea...

Страница 25: ...est POST which tests monitor circuitry and functions 3 Ensure the monitor sounds the power on beep tones and all displays and indicators are illuminated for 3 seconds CAUTION The power on beep tones w...

Страница 26: ...h the monitor in the normal monitoring mode 1 Press and hold the Mode button for 3 seconds until the monitor enters Configuration mode 2 Press the Mode button twice until the Time indicator and Hour s...

Страница 27: ...flashing Set current day using the Up Down selection buttons 8 Pressing buttons other than the Mode button also returns to normal operation If there is no activity for 5 seconds the monitor will retu...

Страница 28: ...ent type indicators are on a selected Patient type indicator is shown flashing 2 Select a desired patient type using the Up Down selection buttons 3 Press any other button to return to normal operatio...

Страница 29: ...ration mode Once the monitor is in the Configuration mode current NIBP unit is flashing on the display 2 Select a NIBP unit either mmHg or kPa using the Up Down selection buttons 3 Press any other but...

Страница 30: ...manual With the monitor in the normal monitoring mode 1 Press the Mode button until the Temperature units and modes are on a selected unit mode is shown flashing 2 Select desired temperature unit and...

Страница 31: ...indicator and current pulse tone volume are displayed 2 Select a level of pulse tone volume between 0 and 8 using the Up Down selection buttons 3 Press any other button to return to normal operation I...

Страница 32: ...ing indicator and current alarm volume are displayed 2 Select a level of alarm volume between 1 and 8 using the Up Down selection buttons 3 Press any other button to return to normal operation If ther...

Страница 33: ...e version 3 Press the Mode button until DEFAULT RESET NO is displayed 4 To leave the settings unchanged select NO using only the Down selection button To reset the operating parameters to the factory...

Страница 34: ...hange or indicate an alarm condition WARNING Any excessive patient motion may cause inaccurate measurements of non invasive blood pressure Make sure there is no patient motion affected to blood pressu...

Страница 35: ...sing the defibrillator Note A patient s vital signs may vary during administration of agents affecting the cardiovascular system such as those used to raise or lower blood pressure or raise or lower h...

Страница 36: ...around an arm covered in thin clothing Thick clothing or a rolled up sleeve will cause a major discrepancy in the blood pressure reading 5 Wrap the cuff around the patient s arm so that the centre of...

Страница 37: ...ng mode 1 Press the Mode button twice until current NIBP target inflation is displayed 2 Change NIBP target inflation to be desired using the Up Down selection buttons 3 Press any other button to retu...

Страница 38: ...alculated during the inflation in initial measurement and from the next measurement the inflation value will be last systolic BP value 50mmHg Also the inflation value for the Neonatal patient is initi...

Страница 39: ...nflates to a pressure level 20 30 mmHg above the previous systolic reading The automatic NIBP cycles continue until one of the following occurs The monitor reaches the 5 minute limit for a STAT measur...

Страница 40: ...urrent cuff pressures are not dynamically displayed during a STAT reading The measurement displays the NIBP reading from the previous cycle until the current cycle finishes Before the first cycle fini...

Страница 41: ...Inaccurate measurements may be caused by incorrect sensor application or use significant levels of dysfunctional hemoglobin such as carboxyhemoglobin or methemoglobin intravascular dyes such as indocy...

Страница 42: ...sors for SpO2 measurements Other SpO2 sensors may cause improper performance 8 1 General The Smartsigns Liteplus uses pulse oximetry to measure functional oxygen saturation in the blood Pulse oximetry...

Страница 43: ...are Ltd sales department Figure 23 SpO2 Setup Connections 1 Observe all warnings and cautions in the directions for use 2 Carefully apply the sensor to the patient as described in the sensor direction...

Страница 44: ...se amplitude indicator is a segmented display showing the relative strength of the detected pulse As the detected pulse becomes stronger more bars light with each pulse min SYS DIA MAP SpO2 min F C M...

Страница 45: ...riately corrected for the effects of variables that shift the relationship between PO2 and pH temperature the partial pressure of carbon dioxide PCO2 2 3 DPG and fetal hemoglobin Automatic Calibration...

Страница 46: ...s inaccurate measurements and can cause patient injury WARNING Use extreme caution when taking rectal temperatures on children Insert the probe tip only 3 8 inch 1 cm to avoid risk of bowel perforatio...

Страница 47: ...vers The use of any other probe cover or the failure to use a probe cover can endanger patients in the electrical risk point of view and produce inaccurate temperature measurements SYS DIA MAP SpO2 mi...

Страница 48: ...escription of Temperature Operation Setting the Temperature Measurement Mode For the setting the Temperature measurement mode refer to section 6 6 of this manual 1 Press the Mode button until the Temp...

Страница 49: ...into position 3 Insert the tip of the probe into the mouth under the tongue and against a sublingual pocket 4 Hold the probe in place until the measurement is complete When the temperature prediction...

Страница 50: ...displays a walking box a box with the sides illuminated sequentially When the measurement is complete the monitor sounds a tone and displays the measurement in the temperature window Note Be sure that...

Страница 51: ...the patient s buttocks with one hand 5 Insert the probe tip 1 centimeter 3 8 inch inside the rectal sphincter Tilt the probe slightly to ensure good tissue contact and keep the buttocks separated thr...

Страница 52: ...ent type is set to monitored If the measured temperature remains below the minimum measurable temperature for 5 minutes the temperature cycle is terminated and the temperature display goes blank To re...

Страница 53: ...merse or soak the probe in any type of fluid Note Do not autoclave the probe or probe well Note Do not use steam heat or gas sterilisation of the probe or probe well Note Do not use hard or sharp obje...

Страница 54: ...time you change patient type CAUTION The high alarm limit for any vital sign is always higher than the low alarm limit for the same vital sign For example the alarm limit for systolic high is always...

Страница 55: ...Parameter Low Limit Default High Limit Default Resolution Systolic mmHg Neonatal 40 to 115 50 45 to 120 100 5 mmHg 0 7 kPa Pediatric 60 to 155 75 65 to 160 145 5 mmHg 0 7 kPa Adult 60 to 245 75 65 to...

Страница 56: ...press the Up Down selection buttons as needed to change the limit to another value 3 Press the Alarm button once again until Systolic low alarm limit is displayed 4 Leave the limit unchanged or press...

Страница 57: ...limit to another value 3 Press the Alarm button once again until Diastolic low alarm limit is displayed 4 Leave the limit unchanged or press the Up Down selection buttons as needed to change the limit...

Страница 58: ...he limit to another value 3 Press the Alarm button once again until MAP low alarm limit is displayed 4 Leave the limit unchanged or press the Up Down selection buttons as needed to change the limit to...

Страница 59: ...wn selection buttons as needed to change the limit to another value 3 Press the Alarm button once again until Pulse rate low alarm limit is displayed 4 Leave the limit unchanged or press the Up Down s...

Страница 60: ...Down selection buttons as needed to change the limit to another value 3 Press the Alarm button once again until SpO2 low alarm limit is displayed 4 Leave the limit unchanged or press the Up Down sele...

Страница 61: ...by pressing the Alarm Silence Button Note The alarms can be cancelled by pressing the Alarm silence button but battery failure loss of pulse and limit violation alarms cannot be released until the al...

Страница 62: ...ess the Review button to display the newest stored set of patient vital signs data The monitor interrupts the dynamic display of any current vital sign measurement The most current set of stored data...

Страница 63: ...o DIA MAP SpO2 min C SYS DIA MAP SpO2 min F C M mmHg kPa BP 1 SYS DIA MAP SpO2 min C mmHg Data 2 Display Data stored at the measurement completed 18 minutes ago Figure 40 Stored Patient Data Display N...

Страница 64: ...on the screen If the monitor is not printing press the Print button to start printing If the monitor is printing press the Print button to stop printing Note The print button is not enabled during an...

Страница 65: ...rm condition occurs When the Print button is pressed at Stream mode the monitor prints out current measurement data Stream print indicator is on 12 2 Selecting Manual or Stream Printing type This proc...

Страница 66: ...t at one time Batch printing Follow the instructions to print stored data if an optional printer is installed 1 Press Print button when the monitor is in Normal or Review mode If the monitor is not pr...

Страница 67: ...SYS DIA MAP HR O2 TEMP mmHg BPM C 17 26 26 Mar 2004 17 26 127 84 98 68 98 36 1 Figure 42 Real Time Printing Stored Data Print Out Patient Name Patient ID Physician Comments TIME SYS DIA MAP HR O2 TEMP...

Страница 68: ...rint Out at Alarm Condition Patient Name Patient ID Physician Comments TIME SYS DIA MAP HR O2 TEMP mmHg BPM C 17 52 26 Mar 2004 17 52 127 84 98 200 l 75 36 1 Figure 44 Stream Printing at Alarm Conditi...

Страница 69: ...erval NIBP units NIBP Smart Inflation Temperature mode Temperature units Print mode Night panel Nurse call state Date format Sound mode Pulse tone volume Alarm tone volume Alarm limit settings High Sy...

Страница 70: ...uirements 13 2 Cable Connection Figure 46 RS 232 I O connector The Pin layouts as viewed from the rear panel of the monitor are illustrated below 1 2 3 4 6 7 8 9 5 Figure 47 Data Port Pin Layout Table...

Страница 71: ...hrough a customized cable that connects to the Nurse Call connector When the cable is connected and operational the monitor immediately notifies the Nurse Call system when a patient alarm occurs The N...

Страница 72: ...e original carton is not available use a suitable carton with appropriate packing material to protect the monitor during shipping Return the Smartsigns Liteplus by any shipping method that provides pr...

Страница 73: ...o an AC power source as described in the Battery Operation section Note Storing the Smartsigns Liteplus for a long period without charging the battery may degrade the battery capacity A full charge of...

Страница 74: ...s you until approximately 2 inches 5 08 cm of paper have been unrolled 5 Align the paper with the pinch roller attached to the printer door 6 Close the printer door Note To ensure that the paper is al...

Страница 75: ...e loss of software control or a detected hardware malfunction an error code is presented Table 11 Error Codes Error Codes Description E01 Battery failure E02 Abnormally shutdown last time E09 System e...

Страница 76: ...oting information Following is a list of possible errors and suggestions for correcting them 1 There is no response to the Power On Off switch A fuse may be blown Notify service personnel to check and...

Страница 77: ...to provide reasonable protection against harmful interference in a typical medical installation However because of the proliferation of electromagnetic noise in health care environments for example el...

Страница 78: ...red by qualified service personnel when servicing the Smartsigns Liteplus When calling the Huntleigh Healthcare Ltd Technical Services Department you may be asked to tell the representative the softwa...

Страница 79: ...natal Low 20 to 85 High 25 to 90 30 70 Pediatric Low 40 to 125 High 45 to 130 50 100 Adult Low 40 to 195 High 45 to 200 50 110 MAP mmHg Alarm Limits Neonatal Low 30 to 95 High 35 to 100 40 80 Pediatri...

Страница 80: ...ed battery Complies with 91 157 EEC 93 86 EEC and 2006 66 EC 17 3 Environmental Operation Temperature 10 C 50 F to 40 C 104 F Humidity 15 RH to 95 RH non condensing Altitude 700 hPa to 1060hPa Transpo...

Страница 81: ...ult 40 mmHg to 200 mmHg 5 3 kPa to 26 7 kPa Pediatric 40 mmHg to 200 mmHg 5 3 kPa to 26 7 kPa Neonatal 20mmHg to 90 mmHg 2 7 kPa to 12 0 kPa Mean pressure range Adult 45 mmHg to 235 mmHg 6 kPa to 31 3...

Страница 82: ...Without Interference2 20 BPM to 300 BPM 3 digits Low Perfusion2 20 BPM to 300 BPM 3 digits Standards ISO9919 2005 1 Neonate specifications are shown for neonate sensors with the Smartsigns Liteplus S...

Страница 83: ...protection Type BF Applied parts NIBP Defibrillation proof applied parts General Safety 93 42 EEC Medical Device Directive US FDA 21 CFR 820 Code of federal regulations Quality system regulation 91 1...

Страница 84: ...re AAMI SP10 2002 A1 2003 Electronic or Automated Sphygmomanometers EN1060 1 1995 Non invasive sphygmomanometers EN1060 3 1997 Supplementary requirements for electrical mechanical blood pressure measu...

Страница 85: ...facturer with medical devices Marking IEC TR60878 2003 Graphical symbols for electrical equipment in medical practice EN980 2003 Graphical symbols for use in the labeling of medical devices ISO7000 20...

Страница 86: ...y electronic equipment may be affected RF emissions CISPR 11 Class B The Smartsigns Liteplus is suitable for use in all establishments Harmonic emissions IEC 61000 3 2 Complies Voltage fluctuations fl...

Страница 87: ...power mains interruption it is recommended that the Smartsigns Liteplus be powered from an uninterruptible power supply or battery IEC 61000 4 11 40 U T 60 dip in UT for 5 cycles 40 U T 60 dip in U T...

Страница 88: ...r radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with survey accuracy To assess the electromagneti...

Страница 89: ...er Note These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Recommended Separation Distances betwee...

Страница 90: ...ide of the package 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 dec...

Страница 91: ...e 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 specifications...

Страница 92: ...with people in mind AN COMPANY MEMBER OF THE GETINGE GROUP and are trademarks of Huntleigh Technology Limited As our policy is one of continuous improvement we reserve the right to modify designs wit...

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