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PROFESSIONAL MEDICAL PRODUCTS
GImA ABPm PulsE rATE mONITOr
wITh spO
User Manual
ATTENTION: The operators must carefully read and completely understand
the present manual before using the product.
z
0123
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 02 95380056
gima@gimaitaly.com - export@gimaitaly.com
www.gimaitaly.com
2
Contec Medical Systems Co., Ltd
No.112 Qinhuang West Street, Economic & Technical
Development Zone, Qinhuangdao, Hebei Province, 066004
PEOPLE'S REPUBLIC OF CHINA
Shanghai International Trading Corp. GmbH (Europe)
Eiffestrasse 80, 20537, Hamburg, Germany
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Related Manuals for Gima 35111
Summary of Contents for Gima 35111
- Page 1 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 02 95380056 gima@gimaitaly.com - export@gimaitaly.com www.gimaitaly.com PROFESSIONAL MEDICAL PRODUCTS GImA ABPm PulsE rATE mONITOr...
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Page 3: Table Of Contents
INDEX Chapter 1 IntroduCtIon ..............5 General Information ............6 Button Functions ..............8 Interfaces ................8 Accessories ................ 9 Chapter 2 GettInG Started ............10 Open the Package and Check .......... 10 Dry battery installation ............10 Power on the instrument........... 10 Connect Sensor .............. - Page 4 Set File Path ..............39 Set Collection Project ............40 Download Data ..............42 Select the Case to be Edited ..........42 Delete Case ..............43 Copy Case ................ 44 Edit BP Data ..............45 7.10 Edit Trend Graph .............. 46 7.11 Edit of Diagnose Information ..........
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Page 5: Chapter 1 Introduction
Chapter 1 INtroDuCtIoN For an overall introduction to the Blood Pressure Monitor, please refer to General Information. For basic operating instructions, please refer to Button Function. For allocation of interface sockets, please refer to Interfaces. Warning Possible explosion hazard if used in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environments, or nitrous oxide. -
Page 6: General Information
Warning When used with Electro-surgery equipment, you must give top priority to the patient safety. Warning It is recommended that you check if there is any damage on the monitor or the accessories regularly, if you find any damage, stop using it, and contact the biomedical engineer of the hospital or our Customer Service immediately. - Page 7 Safety: This device is defibrillator protected. Note that no precautions specific to the device is required during defibrillation, and defibrillation discharge has no effect on the monitor. The equipment uses the gray silicone airway, in case of the effect to the equipment when defibrillation device was used on the patient.
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Page 8: Button Functions
1.2 Button Functions All the operations of the Blood Pressure Monitor could be completed with the buttons. The names of button are on them. They are: Press the button for a long time, then the system will start. When turning on and off the monitor, the red light and the green both flash once to prompt that the on or off operation is successful. -
Page 9: Accessories
Note Cuff is connected to the monitor through the extended gas pipe. 1 Port of extended gas pipe 2 The socket for Gas pipe Figure 1 The top external airway At the bottom is the socket for USB 1 the Socket for USB, connect the data line to upload data Figure 2 Bottom 1.4 Accessories... -
Page 10: Chapter 2 Getting Started
Chapter 2 GEttING StArtED • Open the package and check • Dry battery installation • Power on the instrument • Connect patient sensors 2.1 open the Package and Check Open the package and take out the equipment and accessories carefully. Keep the package material for possible future transportation or storage. -
Page 11: Connect Sensor
2.4 Connect Sensor Note For information on correct connection of NIBP cuff, refer to Figure 3 Figure 3 CUFF Connection method Connect the sensor between the monitor and the measure part of the patient. Chapter 3 FuNCtIoN INtErFACE • Interfaccia principale •... -
Page 12: Measuring Interface
The boot-strap interface is shown as the follow Figure 4 Common user boot-strap interface 1 Note All interfaces except the trend retain power icon, alarm switch, as well as a small font of the current time. Note After the register overflow, the first record will be overwritten, “Overflow”... - Page 13 The measuring interface is shown as the follow: Figure 6 Measuring interface Note In any interface except the measurement, press key to exit current interface and back to the boot-strap interface. 3.2.1 Spo SEtuP Select [PM SpO SETUP] in the “SYSTEM MENU”. The following menu will pop up.
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Page 14: Patient Information
For the [PULSE SOUND] item, you can choose its state. When it is “ON”, pulse sound plays while the monitor measure the ambulatory blood pressure. When it is “OFF”, pulse sound dosen’t play while the monitor measure the ambulatory blood pressure. For the [SpO ALM HI/LO] item, you can set up [SpO ALM H] and [SpO... - Page 15 3.2.3 Spo tABLE Pick the [SpO TABLE] item in the “SYSTEM MENU” to call up the following menu. Figure 9 table [total]: the number is the total of all data have been measured, while accessing this interface for the first time. The sequence number of the first line currently will be displayed, while changing the data or turning over page.
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Page 16: Measure Result Interface
3.2.4 DEMo function Select the [DEMO] item to enter DEMO status. In the DEMO status, press the “MENU KEY”, and system returns to the “MAIN MENU”. Figure 11 Demo Note In clinical application, this function is forbidden because the DEMO will mislead the medical staff to treat the DEMO waveform and parameter as the actual data of the patient, which may result in the delay of treatment or mistreatment. -
Page 17: System Menu
If there is an error during the measurement, an error message text will ap- pear on the screen. If the ALARM SOUND is set to be on, the sound would occur. Press the SILENCE key to stop the sound and press it once more to continue. - Page 18 Figure 15 System setup “SYSTEM SETUP” menu includes: “LANGUAGE” item has two choices: Chinese, English; “UNIT” item has two choice: mmHg, kPa; “USER PURVIEW” item cannot be operated: all; “MEASURE MODE” item has three options: adult, pediatric, neonatal, “BACKLIGHT TIME(s)”item has four choices: 15, 30, 60, 120. Note “Backlight Time”...
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Page 19: System Time
“AWAKE INTERVAL” (min/h) could be options: 15, 30, 60, 120; “ASLEEP INTERVAL” (min/h) could be options: 15, 30, 60, 120, 240; “AWAKE TIME” and “ASLEEP TIME” transformation unit are 30 minutes. 3.4.2 System time Select “System Time” item in [System Menu], the following menu will pop up: Figure 17 System time Select “Confirm”... -
Page 20: Alarm Setup
3.4.4 Alarm Setup Select “ALARM SOUND” item in [SYSTEM MENU] to switch on or off the sound of alarm. [refer to Figure 19 system menu]. Select “ALARM SETUP” item in [SYSTEM MENU], the following menu will pop up: Figure 19 Alarm setup “SYS ALARM”... -
Page 21: Abpm Menu
“Default” includes the main content: Measure mode: adult; Alarm parameter: High pressure High pressure Low pressure Low pressure mode high limit low limit high limit low limit Adult Pediatric Neonatal Alarm switch: close; Measure unit: mmHg; Ordinary user backlight time: 15s; ABPM switch: close;... - Page 22 In “ABPM” menu, “ABPM ON-OFF” select “ON”, then prompt message of ABPM of the current user, such as: Figure 21 ABPM prompt menu Press button, clear the ambulatory blood pressure measure data, and enter ambulatory Blood Pressure Mode; Press button, save ambulatory Blood Pressure measure data, and enter ambulatory Blood Pressure Mode;...
- Page 23 3.4.6 ABPM Data review 3.4.6.1 ABPM “large-print” Data review Select “ABPM Data” item in “ABPM” menu, the following interface will pop up. Every record is an interface, and display content include: the current user, total of the current user record data, serial number of the record, stored time of the record, high pressure, low pressure, mean pressure, Pulse Rate.
- Page 24 A interface contain 5 records, every record includes time, high pressure, low pressure, mean pressure, Pulse Rate. 3.4.6.3 ABPM trend Press button to select “trend”, in ABPM large-print data review menu, the following interface will pop up: Figure 24 ABPM “trend” Trend interface can trace 100 record trends, if measuring data are more than 100 items, press buttons can glide trend curve for left and right,...
- Page 25 3.4.7 ordinary user Data review 3.4.7.1 ordinary user “large-print” Data review Press button to enter the ordinary user “large-print” data review in boot-strap interface, the following interface will pop up: Figure 25 Ordinary user “large-print” Display content is similar to ambulatory blood pressure large-print data review.
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Page 26: Abpm Working Interface
Display content is similar to ambulatory blood pressure large-print data review. 3.4.7.3 ordinary user Measure Data trends Press button to pop up the ordinary user data table in the ordinary user data table, the interface is as shown: Figure 27 Trends Display content is similar to ambulatory blood pressure large-print data review. - Page 27 If alarm sound occurs, press SILENCE key to stop it and press it again to continue. Long press button, the exit ABPM hint interface will pop up: Figure 29 ABPM exiting prompt interface Press button to exit ABPM working environment, and enter the ordinary user working environment, and display the boot-strap interface;...
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Page 28: Spo Monitoring
Chapter 4 MoNItorING 4.1 What is the Spo2 Monitoring Plethysmogram measurement is employed to determine the oxygen saturation of hemoglobin in the arterial blood. If, for example, 97% hemoglobin molecules in the red blood cells of the arterial blood combine with oxygen, then the blood has a SpO oxygen saturation of 97%. -
Page 29: Precautions During Spo /Pulse Monitoring
Note Do not perform SpO measuring and NIBP measuring on same arm at one time, because obstruction of blood flow during NIBP measuring may adversely affect the reading of SpO value. 4.2 Precautions during Spo /Pulse Monitoring Note 、 Make sure the nail covers the light window; 、... -
Page 30: Maintenance And Cleaning
Figure 31 Mounting of the sensor 4.4 Maintenance and Cleaning Care and Cleaning Warning Turn off the monitor before cleaning the monitor or the sensor Warning Do not subject the sensor to autoclaving. Do not immerse the sensor into any liquid. Do not use any sensor or cable that may be damaged or deteriorated. -
Page 31: Nibp Measuring
Warning 1. You must not perform NIBP measurements on patients with sickle-cell disease or under any condition which the skin is damaged or expected to be damaged. 2. For a thrombasthemia patient, it is important to determine whether measurement of the blood pressure shall be done automatically. The determination should be based on the clinical evaluation. - Page 32 Nota The width of the cuff should be either 40% of the limb circumference (50% for neonates) or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 50-80% of the limb. The wrong size of cuff can cause erroneous readings.
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Page 33: Operation Hints
5.3 operation Hints 1. To start auto measuring: Access ABPM SETUP menu and pick the “Asleep Interval” item and “Awake Interval” item, in which the user may select the time interval value for auto measurement. After that, enter “ABPM” menu and select the entrance, enter into ABPM working environment, and the system is automatically inflated measurement in accordance with the setting time interval. - Page 34 Measurement Limitations To different patient conditions, the oscillometric measurement has certain limitations. The measurement is in search of regular arterial pressure pulse. In those circumstances when the patient’s condition makes it difficult to detect, the measurement becomes unreliable and measuring time increases.
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Page 35: Nibp Error Message And Explanations
5.4 NIBP Error Message and Explanations Explanation Cause Self-test failure A/D sampling error Loose cuff Cuff is not connected correctly Air leakage Air leakage in the valve or airway Atmospheric pressure error Valve cannot be open. Signal is too weak Object measuring the pulse is too weak or the cuff is loose It is over the range... -
Page 36: Transportation And Storage
Figure 33 Replace Rubber Bag in Cuff To replace the rubber bag in the cuff, first place the bag on top of the cuff so that the rubber tubes line up with the large opening on the long side of the cuff. Now roll the bag lengthwise and insert it into the opening on the long side of the cuff. -
Page 37: Key And Symbols
5.7 Key And Symbols Symbols Description Warning – See User Manual Systolic pressure MAP pressure Diastolic pressure Pulse rate (bpm) Adult Pediatric Neonatal ABPM Ambulatory Blood Pressure Monitor INFO Information Open the alarm sound indication Close the alarm sound indication WEEE (2002/96/EC) Type BF defibrillator proofed applied parts Serial number... -
Page 38: Installation Of Software
6.2 Installation of software 1 Place the CD-ROM in the CD-ROM compartment located on your computer. 2 If Auto Play for CDs is enabled, place CD in reader and follow instructions when they appear in the screen; otherwise follow install instructions below: a. -
Page 39: Wear
7.2 Wear Click shortcut key , and the “Lead PlaceMent” dialog box will appear.. Figure 35 Wear You can wear the device accroding to the picture above. Please read the “Matters need” before use. 7.3 Set File Path Downloaded case data will be recorded in the case path.If you want to change the case path, you can click menu item “Set file path”. -
Page 40: Set Collection Project
Patient file path: choose patient file path.After downloading data from t he monitor, the case file is saved in this path. If you choose “ Always use default path “ item, the default case file path is program installation file path. 7.4 Set Collection Project Click shortcut key , or click menu bar... - Page 41 interval is 30 minutes, and the asleep collection interval is 60 minute. The asleep time area and awake time area will be display at the right side. When the parameter setting is finished, click “ Okay “ to upload the project to the monitor.
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Page 42: Download Data
Uploading schedule is as follows: Figure 40 Uploading Schedule 7.5 Download Data Before downloading data, please insure: 1. The monitor is connected with computer accurately. 2. The monitor is on. 3. Ensure that the monitor isn’t connect with patient when the monitor is connected with computer. -
Page 43: Delete Case
In this interface, you can choose the file to save case. If the file has case, the file information will be displayed with list form, including these information:Patient Name,Patient ID, Start Time and File Name.Select the case file to be edited, and click “ Okay “ or double click to open the case file and edit it. -
Page 44: Copy Case
7.8 Copy Case Sometimes before you edit case, you may want to save a copy of originality data.Here you need to copy the case. Our software supplies this function. Choose menu item “ Copy data “, and the interface will appear as follows: Figure 44 Select File to Copy The copying case method is similar to the deleting file method.You can select... -
Page 45: Edit Bp Data
7.9 Edit BP Data You can edit every piece of data.Click shortcut key or select menu item “Edit” to display “BP Data” interface as follows: Figure 46 Editing BP Date Interface In the interface, you can see the particular information of every data. *=0/192(0.0%):192 is total number of data, 0 is the number of deleted data, 0.0% is the percent of deleted data. -
Page 46: Edit Trend Graph
7.10 Edit trend Graph After selecting case file, the BP trend graph will be shown in the screen automatically. In other interfaces you can click shortcut key to enter the BP trend interface .The “BP Trend” has two graph types: color filler type, dotted line type. - Page 47 You can switch from one graph type to another by the “Graph Type” button. When you move the mouse on the trend graph area, on the top of the screen the detail data information about the mouse points will be shown, including the data serial number, collection time and collection date, high/low blood pressure value, pulse rate, comment, etc.
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Page 48: Edit Of Diagnose Information
Figure 51 Stretch Trend Graph (Y-Axis) Figure 52 Shrink Trend Graph (Y-Axis) 7.11 Edit of Diagnose Information Diagnose information includes following items: Patient information, Current Medications, Diagnose Information and Physician information. Select “Patient information”, and display as follows: Figure 53 Edit Patient’s Information... -
Page 49: Set Bp Thresholds
Click “OK”, and the patient information content will be saved in the case file in order to expediently display next time.At the same time all the information will be displayed in the report. 7.12 Set BP thresholds After BP Thresholds being set up, the trend graph will renew automatically, statistic data will be recalculated. -
Page 50: Histogram
7.13 Histogram Click shortcut key , and the following interface will appear. Figure 55 Histogram All: Show all BP data statistics. Day: Show only daytime statistics. Night: Show only nighttime statistics. 7.14 Pie Chart Click shortcut key , and the following interface will appear. Figure 56 Pie Chart The interface is divided into four areas.The most left area is maximum,... -
Page 51: Set Print Report
is the setting area for pie colour and corresponding value, and the BP value and be set by manual method and real-time displays.The forth area has three options including: All, Day and Night. All: Show all BP data statistics. Day: Show only daytime statistics. Night: Show only nighttime statistics. -
Page 52: Print Report Preview
Demographics: include patient information, current medications, examining result summary and physician diagnosis information. Statistics Page: particular data statistic information. BP Summary Page: include BP benchmark value, BP load value, average value and diagnosis value. Colorized Graph Page: display the colorized graph of BP data. Bar Graph Page: display the bar graph of BP data Histograms Page: display the histograms graph of BP data (Selected data in the histograms interface: All, Day, Night) - Page 53 Figure 59 Demographics Page Preview In measure Data Page, if the time is night, the background is gray, and if the Sys or Dia is beyond threshold, the background is red. Figure 60 Measure Data Page Preview...
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Page 54: Help
Figure 61 Measure Data Page Preview 7.17 Help Click shortcut key to pop-up help file.It is the brief explanation for program function. 7.18 Exit Click shortcut key to save configuration information and exit application... -
Page 55: Chapter 8 Troubleshooting Guide
Chapter 8 trouBLESHootING GuIDE Cod Description on in Report Editor Solution No signal Check position of cuff, tighten cuff Overreach movement Remain still during BP reading Measurement timeout Check air hose connections and make certain cuff is tight Airway obstructed Check air hose connections and make certain air tubing is not crimped Measurement cancelled... -
Page 56: Specification
SPECIFICAtIoN Name Ambulatory Blood Pressure Monitor Display 2.4’’ color LCD Display NIBP Specifications Measurement Method Oscillometric method Working modes Automatic Measurement Range Pressure adult 0~290mmHg(0~38.6kPa) pediatric 0~235mmHg(0~31.3kPa) neonatal 0~140mmHg(0~18.6kPa) Pulse: 40~240/min Inflation adult 160mmHg pediatric 120mmHg neonatal 70mmHg Alarm Range adult mode SYS ALM: 40~270 mmHg DIA ALM: 10~215 mmHg... -
Page 57: Appendix
APPENDIX Guidance and manufacturer’s declaration – electromagnetic emissionsfor all EQUIPMENT and SYSTEMS Guidance and manufacturer’s declaration – electromagnetic emission The device is intended for use in the electromagnetic environment specified below. The customer of the user of the device should assure that it is used in such and environment. - Page 58 Guidance and manufacturer’s declaration – electromagnetic immunity – for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING Guidance and manufacturer’s declaration – electromagnetic immunity The device is intended for use in the electromagnetic environment specified below. The customer or the user of device should assure that it is used in such an environment. Immunity test IEC60601 Compliance...
- Page 59 Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM – for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the device The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
- Page 60 Congratulations for purchasing a GIMA product.This product meets high qualitative standards both as regards the material and the production. The warranty is valid for 12 months from the date of supply of GIMA. During the period of validity of the warranty, GIMA will repair and/or replace free of charge all the defected parts due to production reasons.
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