USER MANUAL - medikramer
Contents
1. and keys are used to adjust volume up and down respectively the result of the adjustment will show in the volume indication bar At the lowest and loudest level the following operation is invalid with no click sound d Manual Power off Press the POWER key for 2 seconds when it is in use then the instrument will be power off e Auto Power off The instrument can be power off automatically when no fetal heart beat signal is detected for 2 minutes B Manual FHR a Power on amp fetal heart beat searching Please refer to step a amp b in Auto FHR Accordingly volume adjustment and manual power off or auto power off are similar to that in Auto FHR detection b Enter the manual FHR detection First of all make sure the instrument is in function selection mode When in FHR display mode press MENU once and will show Press to confirm the selection and will keep flickering Then the instrument has entered manual FHR detection c Operation Instruction of manual FHR detection During the flickering of count the sound of the fetal heart beat from the os speaker till it reaches 15 Then press _ will stop flickering and stay displayed The average FHR in this period will be displayed d The following status of displaying the manual FHR value After displaying the value of manual FHR or the ERR sign has shown for 6 seconds the instrument will get back to Transient FHR or Aver2. CL LL AS tery Voltag Indicator Indicator Re Y Auto Average FHR Display A FHR Detection Manual FHR Detection US Sa Note The interface varies according to different setting of the operation 1 The following two signs or displaying are auto set or displayed can not be set by the user HAE run Display Displays the detected FHR Battery Voltage Indicator The quantity of black bars indicates the battery voltage The sign LD shows if the voltage is low So the batteries should be changed What s more if the voltage is too low the protection process will be started with battery sign continuous flickering besides the sign The instrument will stop collecting fetal heart beat signal and cut off the power two minutes later automatically It indicates that the batteries are out of power and the batteries must be renewed at once 2 Two operation modes FHR Display Mode amp Function Selection Mode Please refer to the Operation Instruction for the details Status Indicator It just appears when FHR display mode is selected otherwise in function selection mode os 6e 5 3 Volume Indication It should be set manually with the key of or null il Volume Indication Bar The quantity and height of black bars indicate the volume in six levels It can be set manually by the key and This mark indicates current FH signal intensity in real time under detecting state 4 The following f
3. Other batteries may leak causing severe damage to the instrument 5 When battery voltage is low low voltage hint appears the battery sign is empty and flickering the battery voltage is not enough and batteries should be renewed in time 6 Batteries should be taken out when the instrument is not in use fora long time Useless batteries should be disposed properly and safely according to Environmental Requirement 7 The instrument should be protected from water and moisture III Function The instrument is used to detect FHR and SFH IV Application The instrument is to detect FHR and SFH V Main Technical Index 1 Ultrasonic emitting frequency 2 5MHz Ultrasonic emitting power lt 10mW cm2 Average FHR test range 50 210BPM Manual FHR test range 30 240BPM Transient FHR range 50 240BPM 2 Operating voltage Standard 4 5V 1 5V 3 AA Size Optional 3 6V 1 2V 3 Rechargeable batteries 3 Continuous operation time 8 20 hours The maxim continuous operation time varies according to the volume in operation and the performance of the batteries 4 Operation environment Environment temperature 5 C 40 C Relative humidity lt 80 Atmosphere pressure 86kPa 106kPa 5 Storage environment Environment temperature 10 C 40 C Relative humidity lt 80 Atmosphere pressure 50kPa 106kPa 6 The EUT complied with the requirements of IEC 60601 1 2 VI Structural Composition Probe LCD Display MEN
4. i e Devices for Direct Diagnosis or Detection on Physiological Process hence the product should belong to Class lla l Safe Sign R This sign lies on the nameplate of the host machine indicating the instrument is classified as the Class B equipment with a certain level of protection against the hazard of electric shock WATERPROOF This sign lies on the FHR probe Ultrasonic Doppler indicating the waterproof grade of the probe is IP68 C 0123 This sign lies on the nameplate of the host machine indicating the instrument has obtained the CE Certificate This sign lies on the nameplate of the host machine indicating the User s Manual should be thoroughly read before operation Il Precautions 1 The instrument should not be collided to avoid damage Do not open the instrument since there are delicate circuits inside 2 The instrument surface may be cleaned with corrosion free detergent Never make high temperature disinfection and no corrosive detergent is allowed for cleaning The probe can be disinfected by wiping with a little alcohol 3 After every detecting clean probes with a piece of dry cloth or tissue Keep all parts of the monitor externally clean by washing them with cloth dipped with cleaning liquid regularly Be sure not to get any liquid into the casing and remember to wipe it off after cleaning 4 Alkaline battery of high efficiency is the only kind of batteries that could be used in the instrument
5. Fetal Heart Rate Doppler SRFG 1 SE Compact type USER MANUAL V E 4 0 2010 09 Copyright O Sunray Cem gt E Sua 7 Fetal Monitoring Expert Y since 1992 NEDIKRAMER Table of Contents About the User s Manual Classification of Fetal Heart Rate Doppler Safe Sign Il Precautions Ill Function IV Application V Main Technical Index VI Structural Composition VII Button Description VIII LCD Display Description IX Function Description X Operation Instruction XI Troubleshooting XII Instruction of changing the batteries XIII Requirement of Gel About the User s Manual This manual is only for reference in the instrument operation Manufacturer will not be responsible for any result caused by using this manual for other purpose All the information in this manual are copyright protected and no part of this User s Manual can be copied duplicated or translated into other languages without the company s written permission All the information in the manual is subject to change without prior notice Classification of Fetal Heart Rate Doppler The product is mainly used to detect the fetal heart rate FHR and the sound of the fetal heartbeat SFH The growth and development of a fetus can be found out through examination of these indices In accordance with classification standard in Appendix IX on Medical Device Directive 93 42 EEC the product is consistent with the classification principle 10
6. U POWER Host Probe socket Earphone socket Probe Back clip Probe clip Battery cover Cover Attention Do not release the plug if not necessary You can release the plug only when the instrument is power off Make sure the probe mark A is upwards when you release it Do not swing it when releasing in case of destroying the socket Vil Button Description There are 2 operation modes FHR Display Mode amp Function Selection Mode 1 FHR Display Mode is for FHR Detecting 2 Function Selection Mode is for setting a specific function The two operation modes can be selected by MENU key Please refer to the Operation Instruction for the details POWER Power key It is for controlling the instrument MENU Function selection The function key is for selecting a proper function Volume Up Confirm key In FHR Display Mode it is volume up key in Function Selection it is confirm key It needs to be confirmed after every time selecting a specific function Volume Down Cancel key In FHR Display Mode it is volume down key in Function Selection Mode it is cancel key Note There will be a click sound every time with pressing a key as a confirming response to the pressing If there is no click sound heard the former pressing is invalid A second harder pressing or a pressing for a longer time is required Vill LCD Display Description Volume Indication Bar Alarming Battery Type Status K fi AY Battery Voltage
7. age FHR e Special key response in the manual FHR detection During the counting in manual FHR detection the instrument has no response to or MENU key and can confirm the ending of the counting then the detected FHR value will be shown During the display of manual FHR detection the instrument has no response to MENU 6 seconds after the display it will exit the manual FHR detection automatically and enter Transient FHR or Average FHR detection f If the manual FHR detection is required one more time please repeat the above steps XI Troubleshooting 1 The instrument can not be properly power on or power off Possible cause a The batteries may be installed improperly No sound is heard after pressing the POWER key b The POWER key is not properly pressed There is a click sound after pressing the POWER key but it is not power on Solution a Install the batteries according to the instruction b Press the POWER key harder and for a longer time more than 2 seconds 2 No FHR is heard Possible cause a Wrong probe position b Coupling jelly is not coated to interfere ultrasonic echo Solution Coat a suitable amount of coupling jelly and find out correct fetal heart position 3 Weak FHR or no FHR is shown Possible cause Too weak signal to detect Solution Coat a suitable amount of coupling jelly and find out correct fetal heart position or use manual FHR measurement 4 Battery l
8. ction ee Battery type Press the MENU the forth time A disappears and ee appears then press to confirm this selection Otherwise press to cancel this selection After the showing of OA a ee one by one press MENU key can return to FHR display mode when eS shows not confirmed c Confirmation and cancellation of a selection After a function is selected make sure to press the key to confirm the selection otherwise press to cancel the selection After every confirmation or cancellation the instrument will exit function selection mode and get back to the FHR display mode And after 5 seconds without any operation it will get back to FHR display mode d The setting of volume and function selection status will be stored automatically after confirmation The instrument will stay the former status when power on next time B For Example If alarming is required or not Step1 In FHR display mode press MENU key continuously three times and A will show Step2 Press or to confirm or cancel the selection 2 Backlight Control The instruments backlight design adopts power saving mode it will turn off automatically when there is no button operation or FHR signal Any button operation or FHR signal will light the backlight automatically without manual 3 Auto gain Control The instrument has intelligent auto gain control function it will stay mute when there is no FHR signal in
9. nting period B Battery type Batteries used in the instrument are normal alkaline AA batteries when no battery type sign will show otherwise the rechargeable batteries are in use C Alarming The instrument is in alarming mode when amp is shown Instrument will sing a soft music when FHR is not in the range of 120 to 160BPM X Operation Instruction 1 Function Selection Instruction A Operation Instruction a Enter function selection mode Press MENU when FHR shows entering to the function select state at this time there is no FHR displays but with corresponding function mark simultaneously If the instrument is in FHR display press MENU key so that lt will disappear and the instrument will enter the function selection mode Press to confirm the mode selection b Related signs and functions controlled by MENU key Press the MENU key the signs OA amp GO will show one by one and their functions are respectively Manual FHR Press MENU the first time appears and press to confirm this selection Otherwise press to cancel this selection A Average FHR Press MENU the second time disappears and A appears then press to confirm this selection Otherwise press to cancel this selection a Alarming Press MENU the third time A disappears and amp appears y then press to confirm this selection Otherwise press to cancel this sele
10. our signs or functions must be set in function selection mode please refer to the Operation Instruction Manual FHR detection It flashes when manual FHR mode is selected A Auto average FHR detection It appears when auto average FHR mode is chosen otherwise transient FHR mode is selected a Alarming It displays when audio alarming function is selected ES Battery type It should be set by the users It appears when the rechargeable batteries are used The sign should be chosen not to appear when normal batteries are used Batteries type should be checked before use otherwise the battery voltage indicator would not show the proper voltage IX Function Description A Modes of FHR display a Transient FHR When in transient FHR detecting the instrument detects transient FHR and displays according to the fetal heart beat detected by the probe b Average FHR When FHR display mode is selected the sign of A appears The detected fetal heart beat signal will be detected once every five seconds for the average FHR and the value of FHR will be displayed c Manual FHR When the manual FHR detection is selected in the function selection mode Ohiickers the instrument will be in the timing mode Operator can count according to the sound of fetal heart beat from the speaker Press the confirm key when fetal heart beat reaches 15 and the clock sign stops flickering and stays still The average FHR value will be displayed in the cou
11. ow voltage is shown in a very short time Possible cause a Battery type is not conformed to the instrument type selection b Alkaline battery with low energy is used Solution Adjust battery type to match the used battery or use alkaline battery with high energy XII Instruction of changing the batteries The batteries should be renewed according to the following steps Open the battery cabin press the oval opening button as shown in the picture then push the cover as the arrow on the cabin cover indicates When the cover reaches the position as shown in the picture the battery cabin can be opened smoothly Battery changing Take out the used batteries and install the new ones following the installation sign in the battery cabin Close the battery cabin put the cabin cover at the right place as shown in the picture Push the cover in the opposite direction as the arrow on the cabin cover indicates Then the cabin can be closed smoothly XIII Requirement of Gel Density 1 0 g cm3 Rapiditys1 7m s Impedance 1 7 105g cm2 s Attenuation lt 0 02 dB mm Cem 22 E N EDIKRAMER Q nray 7 Fetal Monitoring Expert ray Since 1992
12. put and with low noise When the instrument detects FHR signal input it will automatically switch auto gain to the maximum to seek for FHR signals then the noise will increase When detects stable FHR signal it will switch auto gain to the optimal proportion This function enables users easily to obtain best FHR signals Herewith it is normal for the increased noise during use The noise will get weak apparently when detects FHR signals 4 FHR Detection A Auto FHR a Power on When the detect is not in use it will be power on if the POWER key is pressed for 2 seconds when in use it will be power off when the POWER key is pressed for 2 seconds Press the POWER key to set up the instrument It starts self check process till shows Then the instrument will be in operation When the instrument is in operation If A shows average FHR is detected otherwise transient FHR is detected b FHR detection Apply jelly on the proper part of the pregnant s abdomen push the probe on it gently making sure of close touching between the probe and the abdomen SFH will be heard at the appropriate part After the sound becomes clear and stays stable for a few seconds proper value of FHR will show on the FHR display area Note abnormal value may appear during the searching of fetal heart beat However proper value can be obtained after clear and stable sound of fetal heart beat is heard c Volume adjustment When in FHR display status
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