Gima VITAL-SNET User Manual Download

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PROFESSIONAL MEDICAL PRODUCTS

Gima S.p.A. - Via Marconi, 1 - 20060 Gessate (MI) Italy
Italia: tel. 199 400 401 - fax 199 400 403
Export: tel. +39 02 953854209/221/225 fax +39 08 95380056
[email protected] - [email protected]

www.gimaitaly.com

GIMA VITAL-SNET MONITOR

User Manual

0123

Fabbricante/Manufacturer:
Shenzhen Creative Industry Co., Ltd. 2/F Block 3 Nanyou Tian’an Industry Town
518054 Shenzhen, GD - P.R.C.

Shanghai International Trading Corp. GmbH (Hamburg)
Eiffestrasse 80, 20537 Hamburg - Germany

ATTENTION: The operators must carefully read and completely understand
the present manual before using the product

M35122-M-Rev

.0.05.11

Summary of Contents for VITAL-SNET

Page 1: ...om www gimaitaly com GIMA VITAL SNET MONITOR User Manual 0123 z Fabbricante Manufacturer Shenzhen Creative Industry Co Ltd 2 F Block 3 Nanyou Tian an Industry Town 518054 Shenzhen GD P R C Shanghai International Trading Corp GmbH Hamburg Eiffestrasse 80 20537 Hamburg Germany ATTENTION The operators must carefully read and completely understand the present manual before using the product M35122 M R...

Page 2: ...pecifications correct methods for transportation installation usage operation repair maintenance and storage etc as well as the safety procedures to protect both the user and equipment Refer to the respective chapters for details The Manual is published in English and we have the ultimate right to explain the Manual Version of This Manual Ver1 0 December 25 2009 Copyright 2009 Shenzhen Creative In...

Page 3: ...g it if the integrity of grounding connection is in doubt the monitor should work by using the built in battery Equipment connected with this monitor should be IEC 60601 1 complied Turn off the monitor and take away the sensors from the patient during MRI scanning Otherwise it may cause burn to the patient and the quality of MRI image or the measurement accuracy of the monitor may be affected Alth...

Page 4: ... III obtained Dispose of the device and its accessories the local law should be followed ...

Page 5: ...Starting the Monitor 8 3 3 SENSOR PLACEMENT AND CONNECTION 9 3 3 1 ECG Cable Connection 9 3 3 2 Blood Pressure Cuff Connection 11 3 3 3 SpO2 Sensor Connection 12 3 3 4 TEMP Transducer Connection 13 3 3 5 Loading printing paper 13 3 3 6 Battery Installation 15 CHAPTER 4 OPERATIONS 16 4 1 INITIAL MONITORING SCREEN 16 4 1 1 Default Display Screen Description 17 4 1 2 Operation Instructions 17 4 2 SPO...

Page 6: ...N 30 CHAPTER 6 PACKAGING AND ACCESSORIES 31 6 1 PACKAGING 31 6 2 ACCESSORIES 31 CHAPTER 7 WORKING PRINCIPLE 32 7 1 HOW TO OBTAIN HIGH QUALITY ECG AND ACCURATE HEART RATE VALUE 32 7 2 THE PRINCIPLE OF NIBP MEASUREMENT 32 7 2 1 Points to be noted in NIBP Measurement 33 7 2 2 Clinical Limitations 34 7 3 THE PRINCIPLE OF SPO2 PULSE MEASUREMENT 34 7 3 1 Working Principle 34 7 3 2 Points to be noted in ...

Page 7: ... 3 Battery Maintenance 37 9 1 4 Service 38 9 2 CLEANING STERILIZATION AND DISINFECTION 38 9 3 CLEANING STERILIZATION AND DISINFECTION OF ACCESSORIES 39 9 4 STORAGE 39 9 5 TRANSPORTATION 39 APPENDIX 40 PROMPT INFORMATION EXPLANATIONS 40 DEFAULT ALARMING VALUES OF ALL PARAMETERS AND SETUP RANGE 41 ...

Page 8: ...plicable to adult pediatric and neonate by patient selection Built in printer is optional to print out waveforms and text information 1 2 Product Name and Model Name Vital Signs Monitor Model PC 900 1 3 Intended Use PC 900 Vital Signs Monitor is intended for using in hospitals to monitor patient s ECG blood pressure SpO2 pulse rate and temperature 1 4 Conformation PC 900 Vital Signs Monitor is mod...

Page 9: ... Pulse sync indicator Neonatal Patient Setup Menu NIBP Start Cancel AC Power Alarm Silence DC Power Print Type BF applied part Up Type CF applied part with defibrillator protection OK Warning refer to User Manual Down Equal potential terminal ECG Lead Selection Nurse call output ...

Page 10: ...s heart rate with ECG lead wires and electrodes it also measures temperature with temperature probe 2 The SpO2 module detects and calculates pulse rate and oxygen saturation SpO2 and provides plethysmogram and perfusion index as well 3 The NIBP module performs the measurement of blood pressure by non invasive way of oscillometric technology including the diastolic systolic and mean arterial pressu...

Page 11: ...3 1 1 Front Panel Figure 3 1 Front panel illustration Description 1 Alarm indicator Indicator Alarm Level Alarm Event Red flashing High priority alarm Exceeding the limits low battery voltage Orange Medium priority alarm Leads or probe off Green light Normal ...

Page 12: ...pO2 Display SpO2 value Unit 9 Bar graph of pulse intensity 10 LCD panel 11 Pulse sync indicatoratient category indicator for adult for pediatric for neonate Patient category is selected under sub menu Patient Info within the setup menu 12 Pulse sync indicator Cardio pulse pulse sync indicator When HR priority indicator is on its flashing is synchronized with heart beat When PR priority indicator i...

Page 13: ...e battery is being used but battery voltage is low the beeper also gives warning Status ON green OFF the battery is being recharged while the device is off 25 Power button Press power button for 3 seconds to start the monitor or shut off the monitor Note Short time pressing power button for entering the Power Saving Mode screen then according to your need to make the device stay in the power savin...

Page 14: ...USE T3 15 A Fuse holder Fuse specification T3 15AL 250V 5 20mm 5 AC100 250V AC power supply socket 6 Loudspeaker 7 Mounting hole for hanging the monitor 8 NET serial communication port which is used to network with central monitoring system optional 9 Nurse call connector 10 Equipotential ground terminal ...

Page 15: ... to the power port of the monitor and the other end to the single phase mains power outlet with protected earth Caution if necessary make the monitor grounded properly by the provided grounding wire 2 When powered by built in battery Install battery refer to Chapter 3 3 5 Battery Installation Caution it s better to recharge the battery after it is used up the charging time should be 13 15 hours lo...

Page 16: ...zation Using dissimilar metals may also increase recovery time after defibrillation 3 Prepare the electrode sites according to the electrode manufacturer s instructions The locations of the electrode are in the following Figure Figure 3 3 Electrode Location Note If skin rash or other unusual symptoms develop remove electrodes from patient 4 After starting the monitor if the electrodes become loose...

Page 17: ...ce of this transient occurring will be decreased To the patient with pacemaker due to that this device has been designed to provide resistance to pacemaker signal interference generally the pacemaker pulse is not counted in heart rate measurement and calculation but when the cycle time of pacemaker pulse is over 2ms it may be counted In order to reduce this possibility observe the ECG waveforms on...

Page 18: ...uctions for NIBP Monitoring When taking the measurement of a pediatric or neonate s less than 10 years old blood pressure do NOT operate in the adult mode The high inflation pressure may cause lesion or even body putrescence It is recommended to take the blood pressure measurement manually Automatic measurement should be used at the presence of a doctor nurse NIBP monitoring is prohibited to those...

Page 19: ...ase follow the steps and procedures in operating it Failure to operate it correctly can cause damage to the SpO2 sensor Operation procedure 1 Connect the SpO2 sensor to the connector labeled SpO2 When unplugging the probe be sure to hold the head of the connector and pull it out 2 If the finger clip SpO2 sensor is used insert one finger into the sensor index finger middle finger or ring finger wit...

Page 20: ...er Connection Connecting methods 1 Attach the transducers to the patient firmly 2 Connect the cable to TEMP probe connector in the front panel Note When unplugging the probe be sure to hold the head of the connector and pull it out 3 3 5 Loading printing paper Operation procedures for loading printing paper 1 Press both OPEN notches with force on printer shield with two thumbs to open it 2 Move th...

Page 21: ... 14 Figure 3 7 Loading and taking out printing paper ...

Page 22: ...n in Fig 3 8 to insert the battery into any one of battery compartments Do not insert battery with their polarities reversed 3 Move the battery baffle to secure battery 4 Close the battery cover Figure 3 8 Battery Installation Note Do not insert battery terminal with its polarities reversed or the monitor can not be started Please take out the battery before transport or storage Underside view ...

Page 23: ...ff from the patient the ECG waveform will become a base line in main display area and Lead off will appear at the left side of prompt info area as shown in Figure 4 2 Figure 4 2 Lead off The LCD screen will display the information by different display views short pressing key to shift screen display among 4 display views ECG waveform screen default screen SpO2 plethysmogram screen SpO2 trend graph...

Page 24: ...ing down timer over limit warning and other error messages for technical warning If more than one event occurs or more status appears the indication message will be displayed alternately at this segment NIBP C D XXX the counting down timer of NIBP measurement is XXX seconds This prompt message appears only when the NIBP measuring mode is set as AUTO X mute C D XXX the counting down timer of alarm ...

Page 25: ...s hardware support PLETH Mark of SpO2 plethysmogram when PLETH displays in title area the main display area will be SpO2 plethysmogram and this display screen is the default screen 36 8 temperature numerical value Main display area When SpO2 sensor is placed on the patient and connected to the monitor well a trace of sweeping waveform plethysmogram will be displayed in the main display area as sho...

Page 26: ...e disable alarm silence 4 3 Trend Graph Display Short pressing Display key to shift the screen view to trend graph display screen as shown in Figure 4 5 Figure 4 5 Trend Graph 4 3 1 Screen Description 12 hours the trend length of trend graph three options 12 24 or 96 hours when the selection is 12 hours the upper trend graph will display SpO2 trend curve for last 12 hours cursor on enable the disp...

Page 27: ...key to move the vertical cursor the list box below will display SpO2 HR value and the time value at the point where the cursor stays Move cursor back and forth this way you can view the SpO2 HR trend 12 24 96 hours long Press key again to exit trend viewing When pressing key or key to move cursor the moving step is variable The rule is that the initial step is 1 point after pressing or key towards...

Page 28: ...groups press key or key to scroll up or down through all the measurement values If NIBP measurement is not more than 6 groups the keys or are not effective key press this key to shift to next display view key print NIBP list key start cancel measuring NIBP key alarm silence switch press it to enable disable alarm silence 4 5 Setup Menu Screen At any display view screen long time press Display key ...

Page 29: ... 4 5 1 ECG and Temperature Setup Figure 4 8 ECG TEMP Setup Screen Screen Description Lead ECG lead selection AVR AVL AVF or V Gain ECG waveform scale 1 2 waveform reduced to half of nominal scale 1 nominal waveform scale 2 waveform with doubled scale 1mV generating internal 1mV calibration signal This signal is used to test the function of the machine It is not used during normal operation The def...

Page 30: ...arm is on indicates PR alarm is off PR Hi high limit of PR alarm range 22 250 PR Lo low limit of SpO2 alarm range 0 248 PI display on means PI display is enabled off means PI display is disabled Operation Instructions 1 Press key or key to move cursor to select parameter 2 Press key to confirm and active this parameter setting 3 Press key or again to adjust or modify parameter value 4 Press key ag...

Page 31: ...mean arterial pressure alarm is off MAP Hi high limit of mean arterial pressure alarm range 28 242 mmHg MAP Lo low limit of mean arterial pressure alarm range 26 240 mmHg Mode NIBP measuring mode manual AUTO 1 AUTO 2 AUTO 240 and STAT etc options AUTO 1 means NIBP measurement takes once every one minute automatically AUTO 60 means NIBP measurement takes once every 60 minutes automatically In AUTO ...

Page 32: ... reminding user that the operation of tourniquet is going to be end after this time period 1 to 60 minutes adjusting range with 1 minute step the default value is 5 minutes If the set value is xx minutes the monitor will produce alarm sound until ending deflation when counting down time reaches to xx minutes The alarm type is high priority alarm For example the duration is 40 minutes the alert tim...

Page 33: ...not be regarded as main alarm notice method please do not entirely relay on it You should combine parameter values with alarm level and patient s clinical behavior and symptom to determine patient s status 4 5 5 System Setup Figure 4 12 System Setup Screen Screen Description Vol set beeper volume 0 7 level adjustable the set 0 i e no sound key beep to turn on off key beep LANG language selection E...

Page 34: ...ata will be cleared that means SpO2 trend graph HR trend graph and NIBP list will become empty 4 5 7 Date Time Figure 4 14 Data Time Setup Screen Screen Description yy 07 mm 09 dd 21 date setting 07 09 21 shows the date is September 21st 2007 hh 10 mm 15 ss 20 time setting 09 20 21 shows the time is10 15 20 4 5 8 Recover Default Settings On Setup Menu screen press button or button to shift cursor ...

Page 35: ...s in power saving mode Short time press power button again to shift screen to Power Saving Mode display screen for exiting the sleeping mode Chapter 5 Technical Specifications 5 1 ECG Monitoring 1 Input signals range in amplitude 0 4mVp 5mVp 2 Heart rate display range 20bpm 300bpm 3 Heart rate display accuracy 1 or 2bpm whichever is greater 4 Heart rate alarm delay time 10s 5 Sensitivity selection...

Page 36: ...80 mmHg Infant 120 mmHg Neonate 90 mmHg 8 Overpressure protection limit Adult 300 mmHg Infan 240mmHg Neonate 150 mmHg 9 NIBP measurement range press unit Adult Infant Neonate SYS mmHg 40 255 40 200 40 135 MAP mmHg 20 215 20 165 20 110 DIA mmHg 10 195 10 150 10 95 10 NIBP accuracy Maximum mean error 5 mmHg Maximum Standard deviation 8 mmHg 11 Measurement mode Manual Auto STAT 5 4 SpO2 Monitoring 1 ...

Page 37: ...tion 12V 2 3AH sealed lead acid battery 5 8 Operating Environment Working Environment Ambient temperature range 5 C 40 C Relative humidity 30 80 Atmospheric pressure 70kPa 106kPa Transport and Storage Environment Ambient temperature range 20 C 60 C Relative humidity 10 95 Atmospheric pressure 50 0kPa 107 4kPa 5 9 Classification Safety standard IEC 60601 1 The type of protection against electric sh...

Page 38: ...e outer package Dimension 360 L 320 W 410 H mm 6 2 Accessories 1 ECG cable with lead wire One set 2 ECG electrodes 20 pieces 3 NIBP cuff One piece 4 SpO2 probe One piece 5 Temperature probe One piece 6 Power cord One piece 7 Grounding wire One piece 8 User manual One copy 9 Quality Certificate One copy 10 Warranty Two copies 11 Packing list Two copies Note The accessories are subject to change Det...

Page 39: ... grounding wire If big interference in ECG continues connect one end of the grounding wire provided with this equipment to the grounding wire on the back panel of this monitor and the other end to the special grounding wire water pipe or radiator A common ECG plate electrode used together with this monitor has short shelf life Generally the shelf life is only one month after the package is opened ...

Page 40: ...defined as systolic pressure while the blood pressure at amplitude of cuff pressure backward reduced according to proper proportion is defined as diastolic pressure The maximum change of pulse pressure occurs at these two points They are equivalent to the point with pulse sound and the point without pulse sound respectively in the Korotkoff Sound Method When the risk of invasive monitoring method ...

Page 41: ... measure if the pediatric or neonate mode is selected 7 2 2 Clinical Limitations 1 Serious angiospasm vasoconstriction or too weak pulse 2 When extremely low or high heart rate or serious arrhythmia of the subject occurs Especially auricular fibrillation will lead to unreliable or impossible measurement 3 Do not take the measurement when the subject is connected with an artificial heart lung machi...

Page 42: ...ffect the accuracy 8 Please do not use the SpO2 sensor when having the MRI or burn may be caused by faradism 7 3 3 Clinical Limitations 1 As the measure is taken on the basis of arteriole pulse substantial pulsating blood stream of subject is required For a subject with weak pulse due to shock low ambient body temperature major bleeding or use of vascular contracting drug the SpO2 waveform PLETH w...

Page 43: ...ly wrapped around the arm according to the operating instructions if the cuff leaks and if the inlet is closely connected with the NIBP jack on the side panel Check if the indicator of the pulse oxygen probe flashes and if the pulse oxygen probe is properly connected to the SpO2 jack on the side panel 2 If the problems still exist please contact the local dealer 8 4 Blank Printing Paper 1 Check wh...

Page 44: ...nce or the yearly maintenance the monitor can be thoroughly inspected by qualified personnel including function and safety examinations If the hospital fails to carry out a satisfactory maintenance program about the monitor it may get disabled and harm the patient s safety and health In case of ECG leads damage or aging please replace the lead If there is any indication of cable and transducer dam...

Page 45: ...unction or is not working please contact the local dealer or our company and we are to offer the best solution as soon as possible for your satisfaction Only qualified service engineer specified by the manufacture can perform the service Users are not permitted to repair it by themselves 9 2 Cleaning Sterilization and Disinfection Kept the monitor from dust It is recommended to clean the outer she...

Page 46: ...he accessories including sensor ECG cable and plugs Do not use damaged accessories Accessories can not be entirely immerged into water liquor or cleanser Do not use radial steam or epoxyethane to disinfect accessories 9 4 Storage If the equipment will not be used for long period of time wipe it clean and keep it in the packaging which shall be kept in a dry and good ventilation place free from dus...

Page 47: ...ff or the patient has very weak NIBP error 3 Blood pressure amplifier overflow due to excessive movement NIBP error 4 Leaking during the pneumatic device testing Cuff error Cuff is not wrapped correctly or is not connected NIBP error 5 Abnormal condition of CPU such as register overflow divided by Air leak Air moving part tube or the cuff leak air NIBP over range The measurement range exceeds 255m...

Page 48: ...0 H 180mmHg 130mmHg 110mmHg SYS Low 30 248 H 60mmHg 50mmHg 50mmHg High 22 232 H 120mmHg 90mmHg 90mmHg DIA Low 20 230 H 50mmHg 40mmHg 30mmHg High 28 242 H 160mmHg 110mmHg 100mmHg MAP Low 26 240 H 50mmHg 40mmHg 30mmHg High 1 100 100 100 100 SpO2 Low 0 99 90 85 85 High 22 250 bpm 180bpm 200bpm 220bpm Pulse rate Low 20 248 bpm 40bpm 50bpm 50bpm High 24 1 46 0 39 0 39 0 39 0 TEMP Low 24 0 45 9 34 0 34 ...

Page 49: ... of the warranty GIMA will repair and or replace free of charge all the defected parts due to production reasons Labor costs and personnel traveling expenses and packaging not included All components subject to wear are not included in the warranty The repair or replacement performed during the warranty period shall not extend the warranty The warranty is void in the following cases repairs perfor...

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