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1.1 General Warnings:

Electrocardiograph system is intended to be used only by

qualified medical staff.

Before use, carefully read this manual and directions for use of

any accessories.

There could be hazard of electrical shock by opening the

system casing. All servicing and future upgrading to this equipment

must be carried out by personnel trained and authorized by

manufacturer.

The electrocardiograph is intended for use only as an adjunct

in patient assessment. It must be used in conjunction with clinical

signs and symptoms.

Do not use the electrocardiograph system during magnetic

resonance imaging (MRI) scanning. Induced current could

potentially cause burns. The device may affect the MRI image, and

the MRI unit may affect the accuracy of device measurements.

Содержание Dena

Страница 1: ...SAADAT Co User Manual Dena Electrocardiograph D00948 V1 Dena 1210 Linux...

Страница 2: ...98 21 77962181 Fax 98 21 77964239 Customer Services Tel 98 21 73098000 98 21 77798910 Fax 98 21 77960761 Cell 98 912 1977157 Legal responsible Trionara Technologies AB Laxfiskev gen 6 433 38 Partille...

Страница 3: ...r Paper 27 Paper loading 27 Recorder Cleaning 30 Section 5 Patient Safety 31 Grounding the electrocardiograph 32 Section 6 Getting Started 33 Section 7 Technical Specifications 35 Section 8 Care and C...

Страница 4: ...mer service Intended Audience This manual is provided for the clinical medical professionals Clinical medical professionals are expected to have working knowledge of medical terminology and procedures...

Страница 5: ...ns used in this Manual A WARNING symbol advises against certain actions or situations that could result in personal injury or equipment damage A NOTE symbol provides useful information and recommendat...

Страница 6: ...g patient applied part with a high degree of protection against shock and is suitable to use with defibrillator simultaneously For protection against defibrillator use only manufacturer recommended ac...

Страница 7: ...1 Section 1 General Warnings Please refer to this section for overall safety information...

Страница 8: ...pgrading to this equipment must be carried out by personnel trained and authorized by manufacturer The electrocardiograph is intended for use only as an adjunct in patient assessment It must be used i...

Страница 9: ...an shall consider all well known side effects when using the electrocardiograph To prevent the environment pollution the device and accessories e g battery shall be disposed in accordance with nationa...

Страница 10: ...tion provided in the APPENDIX IV To prevent EMC effect on the electrocardiograph it should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the...

Страница 11: ..._ Displaying 12 lead ECG waveform _ 6 channel and 12 channel waveform recording Signal recovery accuracy With regard to maximum frequency bandwidth of 150 Hz and sampling rate of 1000 samples s the si...

Страница 12: ...90 Altitude 200 to 3500m Power Supply 100 240VAC 50 60Hz 160 VA Intended Use Dena is an advanced electrocardiograph which is designed to record electrical signals of the heart in maximum twelve channe...

Страница 13: ...Top Panel Display Screen ECG waveforms patient information messages etc are displayed on the screen See 1 1 for details Recorder to load recording paper and record ECG waveforms Control panel to contr...

Страница 14: ...Header Area is at the top of the screen The heart rate patient name ID current date and time and system operating status are displayed in this area This information is displayed on the screen during t...

Страница 15: ...rly by the system and in case of improper connection the related message will appear in this area in red Figure 2 2 4 2 Informative and system error messages area Figure 2 2 1 The system messages are...

Страница 16: ...mv calibration signal Speed Use to adjust the recording speed Reset Use to reset Drift filter and restore signals quickly to the screen Mode Use to select recording mode Start Stop Press to start stop...

Страница 17: ...The device indicator lights up when the device is powered on in the figure 2 3 The power indicator lights green when the device is plugged in in the figure 2 3 The battery indicator illuminates green...

Страница 18: ...For transporting the device Battery Compartment For loading the battery 3A fast fuse 3 Connectors Figure 2 5 Rear Panel If the device is to be stored for a long period more than 10 days the fuse shoul...

Страница 19: ...VAC 160 VA 50 60 Hz The following connectors are located at the right side of the device Connector of ECG cable Network connector Connector for PC connection USB port for data export and software upda...

Страница 20: ...in the system and their charge time are specified in Technical Specification section The icon in the Header Area indicates the battery charge level The table below illustrates the icon in different co...

Страница 21: ...h will turn off automatically if the battery power is too low When the electric power is going out the message BATTERY LOW will be displayed Use only the manufacturer recommended batteries Other batte...

Страница 22: ...les and electrodes make sure that no metal part is in contact with the safety ground Verify that all ECG electrodes are correctly attached to the patient Interference from a non grounded instrument ne...

Страница 23: ...conductor of electricity therefore preparation of the patient s skin is important to facilitate good electrode contact to skin Wash sites thoroughly with soap and water 2 Apply some gel on the skin of...

Страница 24: ...3 Place the chest electrode on proper site and press its suction bulb to attach it to the skin The chest electrodes of 12 lead ECG should be placed in the following sites C1 V1 Fourth intercostal spa...

Страница 25: ...lectrodes Site for electrodes Red R Right arm Yellow L Left arm Black N RF Right leg Green F Left leg White Red C1 Chest White Yellow C2 White Green C3 White Brown C4 White Black C5 White Violet C6 Co...

Страница 26: ...20 Lead Placement Diagram Figure 2 9 Lead placement diagram...

Страница 27: ...low menu Figure 3 1 Navigation Drawer The following items can be set through this menu Rec Type Available options are Auto and Manual Auto In this mode the recording starts automatically and stops at...

Страница 28: ...s might be removed 3dB cutoff frequency of these filters is 25 2Hz 35 2 Hz 75 5 Hz and 150 20Hz The frequency of the selected filter is displayed on the screen By selecting Off you can disable the fil...

Страница 29: ...e noise from the baseline but it will not affect QRS complex components The cut off frequency of this filter increases to about 55Hz in areas where the signal slope is high and decreases to about 10Hz...

Страница 30: ...this filter In some cases using the EMG filter may affect P QRS and T waves The EMG filter is designed only for ECG signals In case of other applications e g calibration turn off this filter Lowpass a...

Страница 31: ...2 5 mm s 25 mm s 50 mm s 12 channel waveform recording Real time and Synchronic recording For details on recording settings please refer to section 2 Rec Setting Menu and Rec Mode Signal recovery accu...

Страница 32: ...mode and press Lead and Lead keys to choose between lead groups Then press the Start Stop key to start recording Automatic Recording Press Mode key on the screen or the control panel to toggle between...

Страница 33: ...n as shown in the figure below Do not touch the recorder head while recording and immediately after recording because it is so hot and may lead to personal injury including burns Use only the manufact...

Страница 34: ...28 Open the recorder door Place the paper roll in the compartment Close the recorder door firmly...

Страница 35: ...loading the paper in the recorder Avoid damaging the thermosensitive printhead Do not touch thermosensitive print head It is recommended to use the paper with coloured marks intended to aware user tha...

Страница 36: ...the head elements and platen roller surface using a cloth moistened with alcohol Wait until the alcohol dries then close the recorder door Do not clean the recorder immediately after recording because...

Страница 37: ...IEC60601 1 The modules with this symbol contain a CF Type Cardiac Float and Defibrillation Proof applied part providing a high degree of protection against shock and is usable during defibrillation F...

Страница 38: ...the instrument to the power line ground protective earth when plugged into an appropriate 3 wire receptacle If a 3 wire receptacle is not available consult the hospital electricians If there is any d...

Страница 39: ...tributor immediately 6 2 Connect the power cable to the device Make sure the AC power supply complies with the following specification 100 240 VAC 50 60Hz Plug the power cable to the power supply sock...

Страница 40: ...only connect the system to AC INPUT The battery needs to be charged after transportation or storage If the power cable is not plugged in before turning on the device the device may not work properly b...

Страница 41: ...Tuch screen 10 1 Resolution 1024 600 Waveforms 12 Lead ECG Numeric Parameters HR Operation Method Membrane Keys and Touch Displayed data Waveforms Data Time Recording Speed Sensitivity Operation Mode...

Страница 42: ...date and time paper speed sensitivity filter Recording Mode Normal Recording Format Auto 12 Auto 6 Manual 12 Manual 6 GENERAL Safety Class I Based on IEC60601 1 Protection Against Defibrillator AC Po...

Страница 43: ...eer of the hospital or the manufacturer After Sales Service The overall check of the device including the safety check should be performed only by qualified personnel All checks which need the electro...

Страница 44: ...otherwise indicated in the instructions delivered with accessories or your hospital s maintenance schedule 3 If you see any signs of damage or deterioration in the device and its accessories do not us...

Страница 45: ...use clean and soft cloth with neutral detergent and with Isopropyl alcohol may be used for cleaning and disinfection Accessories To clean disinfect and sterilize reusable ECG cable lead wires electrod...

Страница 46: ...nd a cotton swab Wait until the alcohol dries then close the recorder door The following table summarizes the methods of cleaning disinfecting and sterilizing different parts of the device Do not clea...

Страница 47: ...when stipulated as necessary in the Hospital Maintenance Schedule Trolley In between patients and as required use Isopropyl alcohol Display screen In between patients and as required Clean and soft cl...

Страница 48: ...se button 3 The recorder function Monthly check of the following items is recommended 1 Calibration label Send the system to the manufacturer for calibration on the predetermined date 2 The system int...

Страница 49: ...the touch screen Correct function of the keyboard Cleaning and disinfection according to the user manual Correct display of Waveform area and information Display screen 2 Unplugging the system check t...

Страница 50: ...45 SAADAT Co Form No PL F 33 PM Form Electrocardiograph Name and signature of person in charge Name and signature of expert...

Страница 51: ...Services NO ECG waveform ECG cable connection failure Faulty ECG cable Improper placement of electrodes Check ECG cable connection Short circuit all leads with each other If ECG cable is ok lead erro...

Страница 52: ...Insufficient gel is applied Contact with metal parts of bed trolley etc Lead wires patient cable or power cable fails to make connection There are other electronic devices in the vicinity of the elect...

Страница 53: ...electrode Adult FIAB Ref F9009SSC P28043 EKG Clamp electrodes Pediatric FIAB Ref F9023SSC P28047 ECG Suction chest electrode Pediatric FIAB Ref F9015SSC P28048 Electrocardiograph Cable 10wires Banana...

Страница 54: ...ual Auto Auto Modes 6 12 12 Rec State Sync Real Time Sync Header ON OFF ON Rhythm Lead I II III aVL aVF aVR V1 V2 V3 V4 V5 V6 I Manual Modes 12 6 12 Header ON OFF ON Rhythm Lead I II III aVL aVF aVR V...

Страница 55: ...electrode is properly connected to patient The message is displayed in red color on the screen CHECK C4 Improper connection of C4 electrode Make sure that C4 electrode is properly connected to patien...

Страница 56: ...ff and on 2 Make sure that the battery is sufficiently charged If the problem still exists contact the manufacturer s After Sales Service The message blinks in yellow color on the screen Time out Erro...

Страница 57: ...the electromagnetic environment specified To prevent EMC effect on the Electrocardiograp the system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use i...

Страница 58: ...ker emissions IEC 61000 3 3 Complies Guidance and manufacturer s declaration electromagnetic immunity The Dena 1210 is intended for use in the electromagnetic environment specified below The customer...

Страница 59: ...location in a typical commercial or hospital environment l e v e l st e t of tion ca pli p a to rior p e g a volt ins a m c a the is T U NOTE Guidance and manufacturer s declaration electromagnetic im...

Страница 60: ...unications t n e m p i qu e Test frequency MHz a d n a B MHz a Service b lation du Mo Maximum power W Distance m IMMUNITY TEST LEVEL V m 385 380 390 TETRA 400 Pulse b tion a odul m 18 Hz 1 8 0 3 27 45...

Страница 61: ...and 7 Pulse b tion a odul m 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse b modulation 217 Hz 0 2 0 3 9 5500 5785 a For some services only the uplink frequencies are included b The carrier shal...

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