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Gima 35120, Manual

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User Manual for Vital Signs Monitor

40

Relative humidity: 10 ~ 95%

Atmospheric pressure: 50.0kPa ~107.4kPa

6.9 Classification

Safety standard

IEC 60601-1

The type of protection against electric shock

Class

Ⅰ

equipment.

The degree of protection against electric shock

Type BF, CF applied parts

Electro-Magnetic Compatibility:

Group I, Class A

Summary of Contents for 35120

Page 1: ...SIGNS MONITOR PC 900 M35120 GB Rev 3 09 21 PROFESSIONAL MEDICAL PRODUCTS Gima S p A Via Marconi 1 20060 Gessate MI Italy gima gimaitaly com export gimaitaly com www gimaitaly com Made in China 0476 3...

Page 2: ...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 No pa...

Page 3: ...canning Use during MRI could cause burns or adversely affect the MRI image or the monitor s accuracy 0 If you have any doubt to the grounding layout and its performance you must use the built in batte...

Page 4: ...e who have anaphylaxis 0 All the connecting cables and rubber tubes of the applying parts should be kept away from the patient s cervix to prevent any possible suffocation of the patient 0 All the par...

Page 5: ...e Package and Check 8 3 2 2 Connecting the Power Supply 8 3 2 3 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...

Page 6: ...System Setup 32 4 7 6 Patient Info 33 4 7 7 Date Time 34 4 7 8 Recover Default Settings 34 4 8 POWER SAVING MODE 34 CHAPTER 5 ALARM 35 5 1 ALARM PRIORITY 35 5 2 ALARM MODES 35 5 3 ALARM SILENCE 36 5 4...

Page 7: ...aused by pathology reason 46 8 3 4 Clinical Limitations 46 8 3 5 Points to be noted in SpO2 and Pulse Measuring 47 8 4 TEMPERATURE MONITORING 47 CHAPTER 9 TROUBLESHOOTING 48 9 1 NO DISPLAY ON THE SCRE...

Page 8: ...tal Signs Monitor VII 11 1 PROMPT INFORMATION EXPLANATIONS 52 11 2 DEFAULT ALARMING VALUES AND SETUP RANGE 53 11 3 ABBREVIATION OF ARRHYTHMIA 54 11 4 ACCESSORIES LIST 55 11 5 INSTRUCTIONS FOR SPO2 PRO...

Page 9: ...nter 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 This Monitor is a multi functional instrument designed fo...

Page 10: ...Pediatric Patient 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...

Page 11: ...oosing necessary modules Therefore your monitor may not have all the monitoring functions and accessories 1 ECG TEMP module measures ECG signal and detects heart rate with ECG lead wires and electrode...

Page 12: ...Appearance 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 volt...

Page 13: ...ally 7 PR priority indicator if PR indicator is on it indicates that the numerical value beside is pulse rate value Unit bpm beats per minute If SpO2 and NIBP are monitoring at the same time only the...

Page 14: ...reen this device is using mains power supply ON green ON orange this device is using mains power supply and the battery is being recharged OFF ON green the battery is being used OFF ON orange blinking...

Page 15: ...an community Manufacturer including address and date Disposal of this device according to WEEE regulations 4 FUSE T3 15 A Fuse holder Fuse specification T3 15AL 250V 5 20mm 5 AC100 240V AC power suppl...

Page 16: ...ection to the equipotential grounding system Connect one end of the provided ground cable to equipotential grounding port on the rear of the monitor and connect the other end to one point of the equip...

Page 17: ...zation Using dissimilar metals may also increase recovery time after defibrillation 3 Prepare the electrode sites according to the electrode manufacturer s instructions 4 Skin clean Clean and dry abra...

Page 18: ...White Yellow C2 Brown Yellow V2 4th IC space at left border of sternum White Green C3 Brown Green V3 Midway between V2 and V4 White Brown blue C4 Brown Blue V4 5th IC space on left midclavicular line...

Page 19: ...nal check first When removing the ECG cable hold the head of the connector and pull it out When the monitor is inoperable due to an overload or saturation of any part of the amplifier it will prompt L...

Page 20: ...ssure will increase automatically until it exceeds the limit value specified in table A This pressure limit value depends on the patient type selection as shown in table A Adult 240mmHg Child 200mmHg...

Page 21: ...ed at the presence of a doctor nurse 0 NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with sickle cell disease or partial bleeding will appear 0 Pay attention to the co...

Page 22: ...3 3 3 SpO2 Sensor Connection SpO2 sensor is a very delicate part Please follow the steps and procedures in operating it Failure to operate it correctly can cause damage to the SpO2 sensor Operation pr...

Page 23: ...steam or ethylene oxide Safety Introductions for SpO2 Monitoring 0 Continuous use of SpO2 sensor may result in discomfort or pain especially for those with microcirculatory problem It is recommended...

Page 24: ...put the paper roll into the compartment 5 Pull the paper out of paper slot on the shield 6 Move the tab of the rubber roller lock 90 downwards to lock it 7 Put the shield back in position and secure...

Page 25: ...e button to open the paper cartridge Step 2 Install the paper to the printer properly pull the paper out of the printer for 2 cm as shown in figure 3 10 Step 3 Close the printer cover along the direct...

Page 26: ...ction as shown in Fig 3 11 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 batte...

Page 27: ...is similar Figure 4 1 ECG SpO2 monitoring screen Lead off Probe off Insert the ECG cable and SpO2 probe cable into the socket labeled ECG and SpO2 then attach the ECG leads to the electrodes placed on...

Page 28: ...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 pro...

Page 29: ...off ECG Lead off and SpO2 Probe off manually after alarm lasts for 5 minutes system will resume alarm silence status Figure 4 3 Alarm setup shortcut screen Alarm setup operation description 1 Press ke...

Page 30: ...play area When ECG leads is attached on the patient and connected to the monitor well ECG waveform will be displayed in the main display area Prompt Info Probe off the SpO2 sensor is disconnected from...

Page 31: ...Instructions 1 Press key or key to highlight trend length or cursor on selection 2 Press key to confirm 3 Press key or key again to select value of trend length 12 24 96 hours if the selecting box st...

Page 32: ...the date the second column is NIBP measuring time the third column is NIBP value and the fourth column is pulse rate measured by NIBP module Up to 12000 groups of nonvolatile data can be stored in the...

Page 33: ...previous next page for view other measurement values If SpO2 measurement is not more than 8 groups the keys or are not effective key short press this key to shift to next display view Long press to e...

Page 34: ...ff thereafter the ECG data measured will not be stored 4 7 Setup Menu Screen At any display view screen long time press Display key to shift the screen to Setup Menu screen as shown in Figure 4 10 All...

Page 35: ...CG waveform scale 1 4 Waveform scaled with 1 4 of the base gain 1 2 Waveform scaled with half of the base gain 1 Waveform scaled with base gain 2 Waveform scaled with twice of the base gain 1mV genera...

Page 36: ...m range 1 100 SpO2 Lo low limit of SpO2 alarm range 0 99 PR pulse rate alarm switch indicates PR alarm is on indicates PR alarm is off PR Hi high limit of PR alarm range 22 250 PR Lo low limit of SpO2...

Page 37: ...m is on indicates systolic pressure alarm is off DIA Hi high limit of diastolic pressure alarm range 22 230 mmHg DIA Lo low limit of diastolic pressure alarm range 20 228 mmHg MAP mean arterial pressu...

Page 38: ...monitor will re inflate to maintain the cuff pressure close to the preset pressure value Note the unit of cuff pressure is the same with the NIBP unit in NIBP Setup Duration After presetting the cuff...

Page 39: ...detection for ten seconds then the blood pressure module will deflate automatically and the screen displays measurements The NIBP calibration and Gas leak detection can only be carried on when the NI...

Page 40: ...signal will not be sent out Duration two options pulse or continuous output modes are available continuous the continuous mode of output means the nurse call signal will keep until the selected alarm...

Page 41: ...rom the monitor for demonstration and testing purpose When the mode Demo is selected the user can test whether the visual and audible alarm system runs normally by raising or lowering the alarm limit...

Page 42: ...ctory default setting value 4 8 Power Saving Mode On the initial display screen you can make the monitor stay in power saving mode for power saving Short time press power button to shift screen to Pow...

Page 43: ...des When an alarm occurs the monitor responds with visual alarm indications which are shown by two ways alarm indicator and alarm message description and audible alarm indications Visual Alarm Indicat...

Page 44: ...the monitor alarms press key to suspend the alarm and set the alarm silence time 0 DO NOT silence the audible alarm or decrease its volume if patient safety could be compromised 0 zero value alarm oc...

Page 45: ...rate alarm delay time 10s 6 Response time to change in heart rate Change from 80 bpm to 120 bpm 8 sec Change from 80 bpm to 40 bpm 8 sec 7 Tall T wave rejection Rejects all T wave less than or equal...

Page 46: ...8 sec 8 sec 6 2 TEMP Monitoring 1 TEMP measuring range 21 0 50 0 2 TEMP measuring accuracy not greater than 0 2 o C for TEMP measuring range from 25 0o C 45 0 o C 3 TEMP responding time 150s 6 3 NIBP...

Page 47: ...ate measuring range 30bpm 240bpm 2 Pulse rate measuring accuracy 2bpm or 2 whichever is greater 6 6 Data Recording 1 Sensitivity selection tolerance 5 2 Recording speed 25mm s 3 Recording speed accura...

Page 48: ...mospheric pressure 50 0kPa 107 4kPa 6 9 Classification Safety standard IEC 60601 1 The type of protection against electric shock Class equipment The degree of protection against electric shock Type BF...

Page 49: ...nst damage in the shipping and handling process Weight Details see the indication on the outer package Dimension 360 L 320 W 410 H mm 7 2 Accessorie Adult SpO2 probe 15044074 Power cord 2903 0100003 G...

Page 50: ...re below shows the system of the heart First of all the hospital should be equipped with a 100 240V power supply system with a typical grounding wire If big interference in ECG continues connect one e...

Page 51: ...an that of human ears the oscillating method uses different definitions for measurement of diastolic pressure mean arterial pressure and systolic pressure from the Korotkoff Sound Method When the osci...

Page 52: ...se speed and heart rate has little effect on the measurement accuracy 3 Statistics show that when measuring the hypertension the measure taken by the oscillating method is likely to be lower than that...

Page 53: ...f no less than 1 47kPa 11mmHg Note Some practitioners may report big discreteness or abnormal value of the blood pressure measures when the oscillating method is used As a matter of fact the so called...

Page 54: ...arterial occlusion exists near sensor Obvious venous pulsations Peripheral arterial pulsation becomes weak Peripheral blood supply is not enough 8 3 4 Clinical Limitations As the measure is taken on t...

Page 55: ...judgment rather than the monitor readout A functional tester cannot be used to assess the accuracy of the pulse oximeter monitor or a SpO2 sensor However a functional tester such as SpO2 simulator ca...

Page 56: ...e cuff is properly 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...

Page 57: ...oroughly inspected by qualified personnel including function and safety examinations The designed life of this monitor is 5 years In order to ensure its long service life please pay attention to the m...

Page 58: ...y there is still small drain current inside battery so it is suggested that user should press the power button again to cut off the power supply If battery keeps in a state of small drain current batt...

Page 59: ...luding sensor leads and plugs with a piece of gauze which has been soaked in 75 Alcohol or 70 Ispropanol before use 0 Do not use damaged accessories 0 Accessories can not be entirely immerged into wat...

Page 60: ...ecause of the cuff or the patient has very weak pulse NIBP error 3 Blood pressure amplifier overflow due to excessive movement NIBP error 4 Leaking during the pneumatic device testing Cuff error Cuff...

Page 61: ...50bpm TEMP High limit 39 0 39 0 39 0 Low limit 35 0 35 0 35 0 The high and low limits setting range Mode Parameter Adult Pediatric Neonate HR High limit 1 350 bpm 1 350 bpm 1 350 bpm Low limit 0 349...

Page 62: ...VE COUPLET Ventricular Couplet 8 SVE COUPLET Supra ventricular Couplet 9 VE RUN Ventricular Run 10 SVE RUN Supra ventricular Run 11 VE SHORT RUN Ventricular Short Run 12 SVE SHORT RUN Supra ventricula...

Page 63: ...uff Optional 15022402 Middle sized Pediatric NIBP cuff Optional 15023402 Large sized Pediatric NIBP cuff Optional 15020400 Neonate NIBP cuff 5 4 9 1cm Optional 15084120 Skin TEMP probe 5101 5236310 Th...

Page 64: ...ith a solution such as 70 isopropyl alcohol If low level disinfection is required use a 1 10 bleach solution Warnings 1 Some factors may affect the accuracy of saturation measurements Such factors inc...

Page 65: ...opropyl alcohol If low level disinfection is required use a 1 10 bleach solution Caution Do not sterilize by irradiation steam or ethylene oxide Warnings 1 Some factors may affect the accuracy of satu...

Page 66: ...cting Surface clean sensor and cable with a soft gauze pad by saturating it with a solution such as 70 isopropyl alcohol If low level disinfection is required use a 1 10 bleach solution Caution Do not...

Page 67: ...evel disinfection is required use a 1 10 bleach solution Caution Do not sterilize by irradiation steam or ethylene oxide Warnings 1 Some factors may affect the accuracy of saturation measurements Such...

Page 68: ...e offers a 6 month warranty against manufacturing defects for the SpO2 sensors mentioned above in its undamaged condition If you have any question regarding any of SpO2 sensor instructions please cont...

Page 69: ...1 Guidance and manufacturer s declaration electromagnetic emission The Vital Signs Monitor is intended for use in the electromagnetic environment specified below The customer or the user of the Vital...

Page 70: ...ower quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC61000 4 11 5 UT 95 dip in UT for 0 5...

Page 71: ...tions equipment should be used no closer to any part of The Vital Signs Monitor including cables than the recommended separation distance calculated from the equation applicable to the frequency of th...

Page 72: ...abnormal performance is observed additional measures may be necessary such as re orienting or relocating The Vital Signs Monitor b Over the frequency range 150 kHz to 80 MHz field strengths should be...

Page 73: ...s and the Vital Signs Monitor as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Watts Separation distance according...

Page 74: ...proof type CF applied part Medical Device complies with Directive 93 42 EEC Product code Keep away from sunlight Lot number Disposal The product must not be disposed of along with other domestic wast...

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