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Philips 50 T Series Скачать руководство пользователя страница 73

Declaration of Conformity

Chapter 11 - Accessories and Technical Specifications

67

Declaration of Conformity

These medical devices comply with the requirements of the Medical
Devices Directive (93/42/EEC) concerning medical devices.

This symbol defines Class 2 radio equipment per 1995/5/EC for which
Member States may apply restrictions on putting the device into service
or placing it on the market. This device is intended to be connected to
the publicly available interfaces (PAI) for use throughout the EEA.

These medical devices comply with the Radio and Telecommunications
Terminal Directive (1999/5/EC).

This product is classified as Class IIb in accordance with Annex IX of the
Medical Devices Directive (93/42/EEC).

Manufactured by:

Philips Medizinsysteme Boeblingen GmbH
Hewlett-Packard Str. 2, Boeblingen,
Germany

Product Name and
Model Number:

Series 50 T (M1310A) Fetal Telemetry
System (all options)

Standards complied with:

Safety, Performance

EN 60601-1:1990

Systems

EN 60601-1-1:1993

Radio

EN 300 220-3:2000

EMC

EN 60601-1-2:1997

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Содержание 50 T Series

Страница 1: ...Series 50 T M1310A Fetal Telemetry System I N S T R U C T I O N S F O R U S E M1310 9001B Printed in Germany December 2001 Edition 1 ...

Страница 2: ...on safety reliability and performance of the equipment if assembly operations extensions re adjustments modifications or repairs are carried out by persons authorized by Philips and the electrical installation of the relevant room complies with national standards and the instrument is used in accordance with the Instructions for Use or User s Guide The following conventions for cautions and warnin...

Страница 3: ... Telemetry System 17 Connecting and Assembling the Antenna 19 Remote Antenna 19 Local Antenna 19 Connecting the Receiver to the Fetal Monitor 21 Connecting Power 23 Setting Up the Transmitter 24 4 Monitoring 25 Prerequisites 25 Underwater Monitoring 25 Switching On the Receiver and the Fetal Monitor 26 Switching On the Transmitter 27 Monitoring Ambulant FHR Using Ultrasound 29 Monitoring Ambulant ...

Страница 4: ... IP 44 Under an Angle Mount 45 On a Flat Surface 46 On Top of a Series 50 Mobile Cart or 8040A 46 On Top of a Series 50 IX XM XMO 47 On a Wall 48 9 Maintenance and Performance Assurance 51 Preventive Maintenance 51 Care and Cleaning 51 Testing the Parameter Signals 52 Testing the Receiver 54 Testing the Interface Between the Fetal Monitor and Receiver 55 Testing the Interface Cable 55 Testing the ...

Страница 5: ...Contents v 11 Accessories and Technical Specifications 63 Compatible Accessories 64 Technical Specifications 66 Declaration of Conformity 67 ...

Страница 6: ...vi Contents ...

Страница 7: ...in a residential area may cause interference in which case the users at their own expense must take whatever measures may be required to correct the interference Warning Failure on the part of the responsible individual hospital or institution employing the use of this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards Warning E...

Страница 8: ...Warning Replace fuse in the receiver with an identical one as marked on the rear of the receiver Warning Do not use brown transducers to monitor patients under water Ultrasound and Toco transducers that are colored blue are watertight and comply with IEC 529 IP68 You can immerse the BLUE Ultrasound and Toco tranducers in water ONLY when connected to the telemetry transmitter NEVER connect blue tra...

Страница 9: ...oppler flow measurements in conjunction with ultrasound fetal monitoring may cause false readings of FHR recording of the trace may deteriorate Also the frequency of the patient s walk may be detected This is more likely when the patient is overweight or has a breech presentation Warning Make sure that all four feet are located firmly in place Cautions Caution SHOCK HAZARD Do not remove the receiv...

Страница 10: ...y Caution Although the transmitter and receiver are chemically resistant to most common hospital cleaners and non caustic detergents different cleaners are not recommended and may stain the transmitter and receiver Many cleaners must be diluted before use Follow the manufacturer s directions carefully to avoid damaging the transmitter and receiver Never use an abrasive material such as steel wool ...

Страница 11: ...ese limits can affect the accuracy of the system the transmitter radio frequency transmission and can damage the components and circuits The system can be stored at ambient temperatures between 40 C and 75 C The blue Toco and Ultrasound transducers are water tight to a depth of 0 5 meters Warning Do not use brown transducers to monitor patients under water Ultrasound and Toco transducers that are ...

Страница 12: ...h are connected together bringing various equipment or parts of a system to the same potential This is not necessarily earth potential The value of potentials of earth may be indicated adjacent to the symbol Earth Terminal This symbol identifies the terminal for connection to an external protective earth system Battery 3 x 1 5V This symbol identifies the transmitter battery holder It takes three 1...

Страница 13: ...he protective earth grounding will cause a potential shock hazard that could result in serious personal injury Whenever it is likely that the protection has been impaired the receiver must be made inoperative and be secured against any unintended operation The patient cable must be positioned so that it does not come into contact with any other electrical equipment Before operation make sure that ...

Страница 14: ...eiver Rear View Transmitter 1 Service Socket Maximum voltage of 12V 2 Socket to Fetal Monitor Maximum voltage of 12V 3 Power Input Socket 100 120V or 220 240V 4 Event Marker Service Socket Maximum Voltage of 5V 5 Toco Socket Maximum Voltage of 5V 6 Cardio Socket Maximum Voltage of 5V ...

Страница 15: ...e The device is intended to be used in labor rooms and delivery rooms and in antepartum testing areas It is not intended to be used for transport monitoring and home use The FHR and uterine activity signals are transmitted continuously via radio frequency from the telemetry transmitter to the telemetry receiver where they are displayed and recorded on the connected fetal monitor The Telemetry Syst...

Страница 16: ...nitor s Instructions for Use or User s Guide Throughout this book Instructions for Use is used to cover both terms Ensure that you read and understand these instructions Refer also to the instructions that accompany any accessories and supplies for example fetal scalp electrodes Compatible Fetal Monitors Fetal Monitor FHR using Ultrasound FHR using DECG Toco IUP FMP The monitor requires Fetal Move...

Страница 17: ... the intermittent tone sounding It can also be used to set Nurse Call volume 4 Nurse Call Light Yellow LED flashes when the Nurse Call Button is pressed on the transmitter 5 Transmission INOP Light Yellow LED lit when the transmitter is switched off is out of range of the receiver is defective and receiver do not have matching serial numbers and channel frequency numbers batteries are exhausted 6 ...

Страница 18: ... Rear View 8 Service Socket 9 Output Socket to Fetal Monitor 10 Antenna Input 11 Antenna 12 Product Serial Number 13 Voltage Switch 220 240V 100 120V 14 Fuses Fuses 100 120V T300 mA 250V 220 240V T125 L 250V 15 Mains Socket 100 120V 220V 240V 50 60Hz 19VA max ...

Страница 19: ...service engineers for servicing 3 Toco Socket For connecting a Toco or IUP transducer 4 Cardio Socket For connecting an ultrasound or DECG transducer 5 On Off Switch 0 Off position 0 On position 6 On Light Green LED lit when the transmitter is switched on 7 Nurse Call Button Pressed to give an optical and acoustic signal to the receiver 8 Channel Frequency Label Shows the channel number of the tra...

Страница 20: ...ransmitter 10 Carrying Clip Clipped to patient s clothes during ambulant monitoring 11 PTT Approval Label 12 Product Number and Serial Number Label Compatible Transducers Telemetry transducers have shorter cables than standard but you can also use standard Series 50 transducers with the Series 50 T See Compatible Accessories on page 64 ...

Страница 21: ... 2 Overview 15 Application Overview This shows external monitoring Internal monitoring using DECG and IUP is possible but is not illustrated Fastening the Belts Switching On Plugging In Applying the Transducers Ambulant Monitoring ...

Страница 22: ...Application Overview 16 Chapter 2 Overview ...

Страница 23: ... is damaged contact the carrier and your local Philips Service Organization Retain the packaging in case you need to return the system 1 Ensure that the contents are complete A Receiver with Antenna Power cable Interface cable to the fetal monitor A Transmitter with 3 batteries Carrying strap Instructions for Use ...

Страница 24: ...m 18 Chapter 3 Setting Up the System 2 Ensure that the number on the Channel Frequency Label A on the transmitter is the same as the number on the receiver If not contact your Philips Medical Response Center or Sales Representative ...

Страница 25: ...ing the Antenna Remote Antenna A remote antenna system if necessary is sent separately with its own installation documentation Connect the Remote Antenna cable to socket A Local Antenna 1 Line up the nodules on the right angle connector with the spaces on the antenna connector 2 Push in and twist ...

Страница 26: ... of the antenna so that the two spaces B are positioned at the top and bottom These fit over the two notches C on the receiver antenna socket 4 Push the antenna onto the input socket 5 Turn the connector screw A clockwise until it stops To remove the antenna from the receiver turn the connector screw A anti clockwise and pull the antenna out of the socket ...

Страница 27: ...ng Up the System 21 Connecting the Receiver to the Fetal Monitor 1 Connect the interface cable to the socket A on the receiver 2 Connect the other end of the interface cable to the telemetry socket B on the fetal monitor Series 50 IX XM XMO Series 50 A and 50 IP ...

Страница 28: ...necting the Receiver to the Fetal Monitor 22 Chapter 3 Setting Up the System 8040A 8041A To use the fetal monitor without telemetry switch off the receiver You do not need to disconnect the interface cable ...

Страница 29: ...he factory but before you connect power 1 Ensure that the voltage switch A is in the correct position for your country The voltage and fuse values are shown on the rear panel B If it is incorrect please contact your Philips Medical Response Center for further assistance 2 Connect the power cord to the mains socket C ...

Страница 30: ...Setting Up the Transmitter 1 Slide back the battery cover 1 2 Insert three 1 5V batteries 2 noting their polarity AA size LR6 type For more details regarding the batteries please refer to Chapter 9 Maintenance and Performance Assurance 3 Close the battery cover 3 ...

Страница 31: ...IP68 to monitor patients under water with the Series 50 T Fetal Telemetry system Warning Do not use brown ultrasound transducers to monitor patients under water Ultrasound and Toco transducers that are colored blue are watertight and comply with IEC 529 IP68 You can immerse the BLUE Ultrasound and Toco tranducers in water ONLY when connected to the telemetry transmitter NEVER connect blue transduc...

Страница 32: ...metry will not function 3 Switch on the monitor and its recorder 4 Switch on the receiver 5 When you switch on The receiver On light A comes on The nurse call light B and the battery low light D are lit for one second The transmission INOP light C lights and stays lit until the transmitter is switched on 6 The telemetry indicator lamp on the monitor lights indicating telemetry monitoring mode 7 Ch...

Страница 33: ... label A on the transmitter is the same as the number on the receiver 2 Fasten the belt around the patient 3 Connect the transducer to the appropriate socket US DECG connection TOCO IUP connection 4 Switch on the transmitter The green On Light B comes on and the receiver s transmission INOP light C extinguishes after three seconds ...

Страница 34: ...ransmitter or attach the carrying belt to the transmitter 7 The operating range of your telemetry system was defined during purchase Find out what it is and make sure that your patient knows the boundaries within which she can walk and still be monitored You must ensure that you have obtained the best possible signal before you allow the patient to ambulate Caution Signal transmission can be distu...

Страница 35: ...etal monitor when they are immersed in water or likely to come in contact with water NEVER immerse the telemetry transmitter in water or other liquids such as cleaning solutions Warning During ambulant FHR monitoring the chance of losing the signal or detecting the maternal heart rate is higher than during stationary monitoring We therefore recommend that you check the mother s pulse periodically ...

Страница 36: ...re allowing the patient to ambulate A trace is produced when the signal quality indicator is yellow but for the best possible trace it should be green continuously A clear sound coming from the monitor indicates that you have the best position for the transducer Monitoring Ambulant FHR Using DECG 1 Check that the DECG transducer stays in position after the patient has moved and that you have not l...

Страница 37: ...ost the uterine activity displayed on the monitor and obtained on the fetal trace 3 If the uterine activity signal is lost or unclear reposition the transducer while the patient is standing and if necessary tighten the belt to stop the transducer slipping Warning While the patient is ambulating the chance of losing the signal or detecting artifacts is higher than during stationary monitoring For e...

Страница 38: ...monitor 2 Ensure that the IUP transducer is positioned at the same height as the catheter sensor tip Using a transducer tip IUP sensor such as M1333A M1333E Koala 1 Set the Toco baseline to 0 by adjusting the Toco baseline on the monitor while the patient is standing 2 The hydrostatic pressure created by the amniotic fluid in the current patient position is displayed 3 If the uterine activity sign...

Страница 39: ...ement Profile Maternal movement due to patient ambulating Turn off FMP External Monitoring Uterine Activity Toco External Artifact on Toco trace Walk frequency is being recorded None Monitoring Intrauterine Pressure IUP Internal Err 3 displayed when using the Series 50 T with an old 8040A Monitor IUP sensitivity setting is incorrect Contact your Philips Medical Response Center to change setting On...

Страница 40: ...Solving Common Monitoring Problems 34 Chapter 4 Monitoring ...

Страница 41: ...of the ultrasound transducer whilst the patient is ambulating may be recorded as fetal movement Connecting the telemetry system to a monitor automatically disables FMP Disconnecting re enables FMP If you require FMP during ambulant monitoring switch it on using the function key on the monitor or the barcode method Solving Common Problems Problem Possible Causes Solutions FMP printed on Series 50 A...

Страница 42: ...Solving Common Problems 36 Chapter 5 Fetal Movement Profile ...

Страница 43: ...race for example when pain medication is administered or when a contraction is felt Depending on the monitor the marker may only function when a Toco or IUP transducer is connected to the transmitter Setting Up the Marker 1 Insert the remote event marker into the remote event marker socket on the transmitter Socket for Remote Event Marker ...

Страница 44: ...Setting Up the Marker 38 Chapter 6 Marking Events 2 Press the button on the remote event marker to mark an event ...

Страница 45: ...he trace Series 50 Fetal Monitors A small arrow A is printed on the FHR scale The arrow starts with the peak to show the exact time when the button is pressed Series 50 Fetal Monitors older versions without enhanced interface 8040A or 8041A A full scale deviation of 100 units B is printed on the Toco scale ...

Страница 46: ...Setting Up the Marker 40 Chapter 6 Marking Events ...

Страница 47: ...on the transmitter This sounds an intermittent tone on the transmitter and the receiver s light A flashes Transmitter Nurse Call Button Receiver Nurse Call Acknowledge Volume Control Button 2 To acknowledge the call and turn off the tone press the Nurse Call Acknowledge Volume Control Button The Nurse Call Lamp A goes out ...

Страница 48: ...e provided that the nurse call is not being currently activated To set the nurse call volume 1 Press the nurse call acknowledge volume control button on the receiver The constant tone increases in volume until it reaches the maximum level when it decreases again 2 Let go of the button when the volume you want is reached ...

Страница 49: ...tor Series 50 IX XM XMO 8040A and 8041A 1 Ensure the locking lever 1 at the base of the fetal monitor is moved fully to the left 2 Slot the feet on the base of the monitor into the slots on the receiver 2 3 Secure the monitor by turning the mounting cam into the lock position 3 ...

Страница 50: ... angle sit the front feet in the front slots 1 along the top of the receiver The small step on each foot helps it locate firmly in place 2 Lower the monitor till the back feet click into the back slots 2 Warning Make sure that all four feet are located firmly in place To remove the monitor from the receiver Holding the monitor in both hands press the lock release buttons lift out the back feet and...

Страница 51: ...ount 1 Slide the feet of the angle mount M1353 63201 into the recesses on top of the receiver 2 Secure the angle mount by turning the mounting cam to the locked position To remove the angle mount from the receiver 1 Turn the mounting cam to the unlocked position 2 Lift off ...

Страница 52: ...f a Series 50 Mobile Cart or 8040A 1 Move the mounting cam on the base of the receiver to the left 2 Slot the feet on the base of the receiver into the slots on the 8040A monitor or Series 50 mobile cart 3 Secure the receiver in place by turning the mounting cam into the lock position For 8040A The actual appearance of the mobile cart may differ from the one shown ...

Страница 53: ...ries 50 Installation and Service Guide for details of how to install the Top Mounting Kit onto the Monitor When it is in position 1 Move the mounting cam on the base of the receiver to the left 2 Slot the feet on the base of the receiver into the slots on the Top Mounting Kit 3 Secure the receiver in place by turning the mounting cam into the lock position ...

Страница 54: ...0 A IP monitor on the receiver you need a Fetal Monitor Wall Mounting Kit M1353 64160 1 To fit the Receiver Mounting Kit to the wall and the telemetry receiver refer to the instructions supplied with the kit 2 Turn the receiver so that the Power On Off button and lights face upwards 3 From above slide the V mounting plate on the receiver into the mounting plate on the wall ...

Страница 55: ...On a Wall Chapter 8 Mounting the Receiver 49 4 Attach the Fetal Monitor Wall Mount to the receiver with 3 screws A 5 Mount your monitor on top of the receiver ...

Страница 56: ...On a Wall 50 Chapter 8 Mounting the Receiver ...

Страница 57: ... Cleaning Keep the outside surfaces of the transmitter and receiver clean and free of dust and dirt Use soap and water or ETHANOL 70 Caution Although the transmitter and receiver are chemically resistant to most common hospital cleaners and non caustic detergents different cleaners are not recommended and may stain the transmitter and receiver Many cleaners must be diluted before use Follow the ma...

Страница 58: ...he transducer sockets but not the transducers themselves 1 Switch on the monitor the recorder and the telemetry receiver 2 Connect the appropriate transducer to each socket on the transmitter 3 Standing within view of the monitor press the Nurse Call Button on the transmitter and switch on the transmitter simultaneously The test runs while the Nurse Call is pressed ...

Страница 59: ...l Correct Monitor Response US 125 is displayed and printed Signal Quality Indicator is green Fetal heartbeat is heard from the loudspeaker Toco A triangle signal with an amplitude of 40 units is displayed and printed Each cycle lasts for 12 seconds DECG 150 is displayed and printed Signal Quality Indicator is green Fetal heartbeat is heard from the loudspeaker ...

Страница 60: ...On Off button to switch the receiver on 3 When you switch on The receiver On light A comes on The nurse call light B and the battery low light D are lit for one second The transmission INOP light C lights and stays lit until the transmitter is switched on The telemetry lamp indicator on the monitor lights indicating telemetry monitoring mode TELE is annotated on the fetal trace ...

Страница 61: ...will go out If they are still lit the receiver is not working properly Contact your Philips Medical Response Centre Testing the Interface Cable 1 Connect the interface cable to the receiver 2 Remove the interface cable from the fetal monitor a If all the lights on the receiver are lit the interface cable is faulty b If the lights on the receiver go out the telemetry interface in the fetal monitor ...

Страница 62: ... green On Off light A comes on showing the transmitter is on 3 Check the red light B situated behind the middle battery If the red light is lit for a few seconds and then goes out the self test is successfully complete the red light blinks or remains on after three seconds change the batteries If the fault continues contact your Philips Medical Response Center ...

Страница 63: ...ce 57 Battery Life When the batteries in the transmitter are low the Battery Low light A on the receiver is lit Battery Low Lamp Caution Use only high quality batteries Remove the batteries if you do not intend to use the transmitter for a long period of time ...

Страница 64: ...perature US TOCO DECG TOCO DECG IUP After Low LIght Comes On Operating Time After Low Light Comes On Operating Time After Low Light Comes On Operating Time Alkaline 1 8 Ah 180 min 40 hrs 100 min 16 hrs 80 min 14 5 hrs NiCd 0 6 Ah Rechargeable 10 min 12 hrs 6 min 5 5 hrs 5 min 4 5 hrs NiMH 1 2 Ah Rechargeable 20 min 22 hrs 12 min 11 hrs 10 min 9 hrs ...

Страница 65: ...tests described in Chapter 9 Testing the Receiver on page 54 The Telemetry Indicator Lamp on the fetal monitor does not light when the monitor and the receiver are switched on Incorrect interface connection between the monitor and the receiver Faulty interface cable Follow the instructions in Chapter 3 for details on how to connect the monitor to the receiver Replace interface cable Contact your P...

Страница 66: ...efer to Chapter 3 for details Battery Low Light lit on receiver Power in batteries is low Change batteries INOP transmission lamp is lit after the patient has moved a short distance away form the receiver Local Antenna Antenna not connected correctly Remote Antenna System Antenna cable not connected correctly to receiver Check antenna is connecting correctly Test the antenna system by bringing the...

Страница 67: ...onitoring Series 50 Family Message Display Cause Solution Err 9 US Toco Invalid telemetry mode Check the cable from the telemetry receiver and if necessary replace it Err 14 US Toco Incorrect transducer connected to transmitter Check that the transducer is compatible with Series 50T Fetal Telemetry System Err 16 US Toco Transducers are connected to the front panel of the monitor Disconnect the tra...

Страница 68: ...Solution Signal indicator lamps flashing Indicator Panel Invalid telemetry mode Incorrect transducer connected into transmitter Only Ultrasound and Toco transducers can be used Transducers are connected to the front panel of the monitor Check the cable from the telemetry receiver and if necessary replace it Check that the transducer is compatible with Series 50T Fetal Telemetry System Disconnect t...

Страница 69: ... fetal monitor s Instructions for Use Refer also to any instructions that accompany the accessories This chapter contains additional information related to the Series 50 T This chapter contains information current at the time of printing Caution Do not use accessories that are not approved by Philips You may damage the equipment and this type of damage is not covered by warranty ...

Страница 70: ...5m 8ft 2in cable M1364A M1364 60001 DECG Legplate Transducer M1357A DECG Adapter M1347A Toco Transducer Telemetry tranducers with a short 70 cm 28in cable blue watertight to IEC 529 IP 68 M1355A Opt C03 M1355 60013 Ultrasound Telemetry Transducer M1356A Opt C03 M1356 60013 DECG Patient Module Short 70 cm 28in cable M1364A M1364 60003 IUP Transducers Pressure Transducer CPJ840J5 Single use Sterile ...

Страница 71: ...995A DECG Cables DECG Cable For M1364A patient module open wire M1362A DECG Adapter Cable For M1364A patient module M1362B Disposable Fetal Scalp Electrodes Double Spiral Electrode 15133D Europe Single Spiral Electrode 15133E USA Marker Remote Event Marker 15249A Accessories Compatible with Series 50 T M1310A Description Product No Option Part No ...

Страница 72: ...rating Voltage 100 to 120V or 220 to 240V 10 Line Frequency 50 to 60Hz Power Consumption 19 VA max Input Sensitivity 118dBm Dimensions and Weight Height 50mm 2in Width 425mm 16 7in Depth 392mm 15 4in Weight 6 5kg 14 3 lb Transmitter Output Power USA 4 mW Europe 2 mW Japan 1 mW Image Rejection 80 dB Batteries 3x1 5V AA size LR6 type Dimensions and Weight without transducers and batteries Height 120...

Страница 73: ... intended to be connected to the publicly available interfaces PAI for use throughout the EEA These medical devices comply with the Radio and Telecommunications Terminal Directive 1999 5 EC This product is classified as Class IIb in accordance with Annex IX of the Medical Devices Directive 93 42 EEC Manufactured by Philips Medizinsysteme Boeblingen GmbH Hewlett Packard Str 2 Boeblingen Germany Pro...

Страница 74: ...Declaration of Conformity 68 Chapter 11 Accessories and Technical Specifications ...

Страница 75: ... artifact 33 35 I interface testing 55 IUP problems when monitoring 33 M maintenance preventative 51 marking events 37 maximum input output voltages 8 monitoring FHR problems using US 33 IUP problems 33 solving common problems 33 Toco problems 33 under water 25 mounting the receiver on a flat suface 46 on a wall 48 on top of 8040A 46 on top of a mobile cart 46 on top of Series 50 47 under a fetal ...

Страница 76: ...2 receiver self test 54 transmitter self test 56 Toco trace artifacts 33 trace erratic 33 transducers and underwater monitoring 25 applying to patient 25 compatible with telemetry 64 watertight blue 5 25 transmitter 13 14 inserting batteries 24 testing 56 U ultrasound problems when monitoring 33 underwater monitoring 25 unpacking the telemetry system 17 uterine activity problems when monitoring us...

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