Gima 35124 User Manual Download

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PROFESSIONAL MEDICAL PRODUCTS

GIMA VITAL SIGNS MONITORS

VITAL PRO-SNET

User manual

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy
[email protected] - [email protected]

www.gimaitaly.com

M-35124-GB-Rev

.0.04.18

0123

Shenzhen Creative Industry Co., Ltd.
2/F Block 3 Nanyou Tian’an Industry Town
518054 Shenzhen, GD - P.R.C.
Made in China (P.R.C.)

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

ATTENTION:

The operators must

carefully read and completely understand

the present manual before using the product.

35124 / PC-900PRO(SNET)

Summary of Contents for 35124

Page 1: ...italy com M 35124 GB Rev 0 04 18 0123 Shenzhen Creative Industry Co Ltd 2 F Block 3 Nanyou Tian an Industry Town 518054 Shenzhen GD P R C Made in China P R C Shanghai International Holding Corp GmbH E...

Page 2: ...res 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 part of this manual m...

Page 3: ...in compliance with standard of IEC 60601 1 1 for medical electric system requirements Check SpO2 probe application site periodically every 30 minutes to determine circulation positioning and skin sen...

Page 4: ...h the monitor which are provided by the same factory otherwise negative effects con cerning safety and biocompatibility etc may be caused DO NOT stare at the infrared light of SpO2 sensor when switch...

Page 5: ...apter 4 Operations 22 4 1 Initial Monitoring Screen 22 4 2 Default Screen 22 4 3 Screen for Real time ECG waveform Only 25 4 4 Screen Display for ECG Waveform Recall 25 4 5 NIBP List Screen 27 4 6 SpO...

Page 6: ...1 Measuring Principle 50 8 2 2 Factors affecting NIBP measuring 51 8 2 3 Clinical Limitations and Contraindications 51 8 3 SpO2 Monitoring 51 8 3 1 Measuring Principle 51 8 3 2 Sources of interference...

Page 7: ...or you purchased may not cover all the mentioned functions according to its configuration 1 2 Product Name and Model Name GIMA VITAL SIGNS MONITOR VITAL PRO SNET 1 3 Intended Use This Gima Vital Signs...

Page 8: ...le lead wires via electrodes The tempe rature is measured through the temperature probe 2 The SpO2 module detects and calculates pulse rate and functional oxygen saturation SpO2 and provides plethysmo...

Page 9: ...display of heart rate pulse rate unit bpm Heart rate is priority to be displayed 6 SpO2 display of SpO2 value Unit 7 LCD panel 8 Power button Long pressing power button to start or shut off the Gima V...

Page 10: ...ressing NIBP setup key 12 will lock or un lock the key operation 14 Patient category indicator for adult for pediatric for neonate 15 Alarm silence key 16 Print The built in printer is optional If ins...

Page 11: ...as shown in figure 3 3 The built in thermal printer is in the left panel It is easy for user to print waveform and data if this is installed printer status indicator One is for power indication of th...

Page 12: ...side of the Monitor Figure 3 5 Underside of the monitor Handle Nameplate NET USB connector Nurse call connector Mounting hole for hanging the monitor AC power supply socket Fuse holder 2xTI 0AL Equipo...

Page 13: ...on how frequently and for how long it is used For a properly maintained and stored lead acid or lithium battery its service life is about 2 or 3 years respectively For more often used models service l...

Page 14: ...est and then enters the initial display The orange alarm indicator blinks to inform that the user can begin operating it Check all the applicable functions to make sure that the monitor works normally...

Page 15: ...the centerline of the right clavicle and Rib 2 Yellow L Black LA Place on the left arm or the intersection between the centerline of the left clavicle and Rib 2 Green F Red LL Place on the left leg or...

Page 16: ...s inoperable due to an overload or saturation of any part of the ampli fier it will prompt Lead off to remind operator No predictable hazard will be caused by the summation of leakage currents when se...

Page 17: ...lation takes place If there is no manual deflation operation the pressure will persist until deflation by the manual valve It is necessary to deflate in several steps to verify the pressure accuracy a...

Page 18: ...it is requested to inspect the luster the warmth and sensitivity of the body extremity frequently On observation of any abnormality im mediately stop the blood pressure measurement The patient should...

Page 19: ...r 11 5 for the detailed instruc tions of each SpO2 probe 3 If the neonate SpO2 sensor is used please follow Figure 3 10 to connect Y type sensor Sensor adapter wrap Figure 3 10 Neonate SpO2 sensor pla...

Page 20: ...the nail may affect the accuracy of measurement The fingernail should be of normal length The SpO2 sensor cannot be immerged in water alcohol or cleanser completely because the sensor has no capabilit...

Page 21: ...lock 90 downwards to lock it 7 Put the shield back in position and secure it Operation procedures for taking out printer paper roll Steps 1 2 Same as above Steps 3 Roll the loading roller anti clockwi...

Page 22: ...ories Note The monitor you purchased may not cover all the mentioned functions according to its configuration 4 1 Initial Monitoring Screen To switch on the Gima Vital Signs Monitor press and hold the...

Page 23: ...h NIBP function only Note if the Gima Vital Signs Monitor is configured with NIBP function only then the monitoring screen shows NIBP list and event list only Title line 000 the ID number of the patie...

Page 24: ...ime the measuring time SYS DIA MAP systolic diastolic arterial mean pressure PR the measured pulse rate from the blood pressure measuring channel or the pulse rate value from oxime try measuring chann...

Page 25: ...and ECG waveform recall The following sections will describe each one of these 7 screens 4 3 Screen for Real time ECG waveform Only Note this screen is only for the Gima Vital Signs Monitor with ECG...

Page 26: ...the valid ECG signal when message Lead off disappears and fini shes when ECG lead is off One single ECG record is not longer than 1 hour Operating instructions Press Up p key or Down q key to select o...

Page 27: ...ialogue for deleting data records where the user can choose to delete all NIBP data records 4 6 SpO2 Data List Screen Note the screen below is only for the Gima Vital Signs Monitor with SpO2 function...

Page 28: ...user can choose to delete all alarm events data 4 8 Trend Graph Display for SpO2 Option The trend graph display screen is as shown in Figure 4 9 Trend graph Trend length Figure 4 9 Trend Graph screen...

Page 29: ...to print this trend graph 4 9 Setup Menu Screen The Setup Menu screen is the main menu screen and a long press of Display View key will enter into the Setup Menu screen as shown in Figure 4 10 Note y...

Page 30: ...G function of the device It is not used during normal ope ration Enhance mode the switch of filter mode Select means enhance mode for the filter with extended bandwidth 0 05Hz 40Hz select means filter...

Page 31: ...s the signal is averaged over a longer period of time than during shorter averaging times However longer averaging times delay the response of the oximeter and reduce the measured variations of SpO2 a...

Page 32: ...it the pressure unit mmHg and kPa for optional NIBP Mode NIBP measuring mode STAT Manual CUSTOM AUTO 1 AUTO 2 AUTO 3 AUTO 4 AUTO 5 AUTO 10 AUTO 15 AUTO 20 AUTO 30 AUTO 40 AUTO 50 AUTO 60 AUTO 90 AUTO...

Page 33: ...automatically and the screen will display the result If the following messages pop up then NIBP measurement should be stopped 1 Pressure verification 2 Air leakage preparing 3 Air leakage countdown 4...

Page 34: ...annot adjust it Hi Lo high and low alarm limit setting for temperature Unit set the temperature unit C and F can be optional Sensor temperature sensor type KRK and YSI can be selected Please set the s...

Page 35: ...t Time the alert time for reminding user that the operation of hemostat 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 t...

Page 36: ...nd Dura tion shown below Source three kinds of alarm sources can trigger the nurse call high level alarm medium level alarm and low level alarm multi optional After selecting the alarm level the devic...

Page 37: ...d anytime 2 The icon on the lower right corner of screen displays the network status 4 9 10 System Setup Figure 4 22A System Setup Screen Figure 4 22B System Setup Screen Screen Description Alarm Vol...

Page 38: ...Settings Press the alarm silence key to set the alarm sound status There are 3 options in total Alarm sound is enabled which is the default status Short term alarm silence 120 seconds a short press of...

Page 39: ...top SpO2 measurement NIBP measurement Hemo stat pressure verification and air leakage checks etc and all key operations will be disabled except power key Chapter 5 ALARMS 5 1 Alarm Priority Low Priori...

Page 40: ...d of alarm silence period if the current alarm condition still exists then the audible alarm indication will resume as well When the Gima Vital Signs Monitor generates alarms the user can press key to...

Page 41: ...OFF the alarm for the setting The alarm silence indicator will reflect this with a yellow light showing that alarms are silenced Refer to Chapter 11 2 for detailed default alarming values of all param...

Page 42: ...erence 5 mmHg Maximal standard deviation 8 mmHg Measurement mode Manual Auto STAT 6 4 SpO2 Monitoring 1 Transducer dual wavelength LED Wavelength Red light 663 nm Infrared light 890 nm Maximal optical...

Page 43: ...ication 11 1V 4400mAh Li ion Battery 6 8 Operating Environment Working Environment Ambient temperature range 5 C 40 C Relative humidity 30 80 Atmospheric pressure 70kPa 106kPa Transport and Storage En...

Page 44: ...mulator e g for Index 2 series SpO2 simulator from Fluke Biomedical Corporation please set Make to DownLoadMake KRK then the user can use this particular R curve to test the oximeter If the SpO2 simul...

Page 45: ...on Ethernet network 5 Display panel color TFT LCD 6 Working modes Demo mode and Real time mode 6 11 Guidance and manufacturer s declaration Electromagnetic compatibility Table 1 Guidance and manufactu...

Page 46: ...of a typical commercial or hospital envi ronment Surge IEC 61000 4 5 1kV line s to line s 2kV line s to earth 1kV differential mode 2kV common mode Mains power quality should be that of a typical comm...

Page 47: ...a Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the com pliance level in each frequency range b Interference may occur in the vicini...

Page 48: ...RF disturbances are controlled The customer or the user of the equipment or system can help prevent electromagnetic in terference by maintaining a minimum distance between portable and mobile RF comm...

Page 49: ...nitor 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 mont...

Page 50: ...are encounte red such as why the measures taken by the oscillating method is lower or higher than those taken by Korotkoff Sound Method Why the measures are inclined to decline Why in some cases no re...

Page 51: ...reliable as reduced pe ripheral blood flow will lead to reduced arterial pulsation 6 Patient with hyperadiposis In addition statistics show that 37 people report blood pressure difference of no less t...

Page 52: ...Make sure that the sensor is lined up so the red and infrared LEDs pass through the capillary arterial vessels The SpO2 sensor should not be used at a location or limb with an arterial or blood press...

Page 53: ...sure cuff is properly wrapped around the arm according to the operating instruc tions that the cuff does not have a leak that connections are secure on the cuff and tubing and that the inlet is closel...

Page 54: ...ce Please pay attention to the polarity of battery and do NOT insert it into battery compartment with polarities reversed Do NOT use batteries manufactured by other companies which may cause damage to...

Page 55: ...in the liquid If the monitor accidentally becomes wet it should be thoroughly dried before use The rear cover can be removed by a qualified service technician to verify absence of water Do not pour t...

Page 56: ...or other hardware error NIBP error 2 Very weak signal because of the cuff or the patient has very weak pulse NIBP error 3 Blood pressure amplifier overflow due to excessive movement NIBP error 4 Leak...

Page 57: ...w limit 90 85 85 Pulse rate High limit 180bpm 200bpm 220bpm Low limit 40bpm 50bpm 50bpm TEMP High limit 39 0 C 39 0 C 39 0 C Low limit 35 0 C 35 0 C 35 0 C Mode Parameter Adult Pediatric Neonate Fase...

Page 58: ...cular Insert 19 VE RONT Ventricular RonT 20 SVE RONT Supra ventricular RonT 11 4 Instructions for SpO2 Probe Instructions for Neonate SpO2 Y type Sensor Intended Use Must be used with a compatible pat...

Page 59: ...ze by irradiation steam or ethylene oxide Instructions for Pediatric SpO2 Finger Clip Sensor Intended Use Must be used with a compatible patient monitor or a pulse oximeter device The sensor is intend...

Page 60: ...ffect performance or accuracy 10 Do not use the sensor if the sensor or the sensor cable appears damaged Instructions for Adult SpO2 Finger Rubber Sensor Intended Use Must used with a compatible patie...

Page 61: ...ow If an index finger cannot be positioned correctly or is not available other fingers can be used 2 Note When selecting a sensor site priority should be given to an extremity free of an arterial cath...

Page 62: ...r modify the sensor Alterations or modifications may affect performance or accuracy 10 Do not use the sensor if the sensor or the sensor cable appears damaged We offer a 6 month warranty against manuf...

Page 63: ...ith household waste Keep in a cool dry place Manufacturer Date of manufacture Authorized representative in the European community Type BF applied part Please read instructions carefully CF type applie...

Page 64: ...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 s...

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