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Fukuda Denshi Dynascope 7100, User Manual

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Fukuda Denshi Dynascope 7100 User Manual Download Page 25

xxv

WARNING

FCC Radiation Exposure Statement:

This equipment with a built-in telemeter complies with FCC
radiation exposure limits set forth for an uncontrolled
environment.  This equipment should be installed and
operated with minimum distance 20cm between the radiator
and your body (excluding extremities: hands, wrists, and feet)
and must not be co-located or operated with any other antenna
or transmitter.

WARNING

Operation of this equipment requires the prior coordination with
a frequency coordinator designated by the FCC for the
Wireless Medical Telemetry Service.

CAUTION

FEDERAL LAW RESTRICTS THIS DEVICE TO SALE
BY OR ON THE ORDER OF A PHYSICIAN.

Summary of Contents for Dynascope 7100

Page 1: ...tions to Peripheral Devices xi Precautions about the Fuse xi Accessories and Optional Accessories xi Precautions about the DS 7100 System xii Precautions for Use of SpO2 Sensor xviii Precautions for Use of NIBP Cuff xviii Disposing of Equipment Accessories or Components xviii Precautions about Transportation xviii Precautions about RTC or Data Backup xviii Precautions for Use of Lithium Ion Batter...

Page 2: ...the equipment CAUTION Failure to follow this message may cause injury or failure to the equipment NOTE A note is not related to product safety but provides information about the correct use and operating procedures to prevent incorrect operation and malfunction of the equipment Labels Attached to the Unit Make sure to read the warning labels attached to the unit and comply with these requirements ...

Page 3: ...ified for this device Do not disassemble or modify the battery The battery incorporates protection circuitry for safety purposes WARNING Installation of the battery should be performed only by our service representative to avoid any risk of electric shock to the operator or malfunction of the device CAUTION The life cycle of the battery is 1 year The battery charges when the power cord is connecte...

Page 4: ... per minute Respiration Rate 2 CO2 RR_CO2 Bpm breaths per minute Impedance Respiration APNEA s second Apnea CO2 APNEA s second Invasive Blood Pressure Invasive Blood Pressure BP mmHg kpa mmHg Non Invasive Blood Pressure Non Invasive Blood Pressure NIBP mmHg kPa mmHg Arterial Oxygen Saturation SpO2 SpO2 Temperature Temperature TEMP C F C End Tidal CO2 Concentration CO2 EtCO2 mmHg kPa mmHg Inspirato...

Page 5: ...7100 System Symbols displayed on the screen Symbol Description Battery Mark Indicates battery capacity and remaining volume during battery operation Alarm OFF Indicates the alarm is OFF Heart Rate Synchronization Mark This mark flashes synchronizing to the heartbeat Respiration Synchronization Mark This mark flashes synchronizing to the inspiration Event Key Mark Displayed when an alarm generates ...

Page 6: ...nction with other equipment as it may cause erroneous judgement and danger Ensure all patient connections are proper and secure During operation of the system verify the following items Always observe the system and patient to ensure safe operation of the equipment If any abnormality is found on the equipment or patient take appropriate measures such as ceasing operation of the equipment in the sa...

Page 7: ...n a local medical institution one person can perform both functions Select a telemetry manager who understands the characteristics and functionality of telemetry systems and is skilled in operating telemetry When installing telemetry the Overall Manager and the Zone Manager have to understand the precautions for use of the telemetry in advance The Overall Manager takes responsibility of wireless c...

Page 8: ...uid spill the monitoring function is interrupted or disturbed parts of the equipment enclosure are cracked removed or lost any connector or cable shows signs of deterioration Reference Refer to 10 Maintenance for details WARNING Never open the housing while the equipment is in operation or connected to hospital grade outlet as it may result in electric shock Maintenance Modifications and Repairs F...

Page 9: ...ace at their maximum programmed rate October 14 1998 Letter www fda gov cdrh safety html FDA Non Explosion Proof DANGER Never operate the equipment in the presence of flammable anesthetics high concentration of oxygen or inside hyperbaric chamber Also do not operate the equipment in an environment in which there is a risk of explosion Explosion or fire may result Defibrillation Safety WARNING When...

Page 10: ... Placement The amount of interference is considerably different depending on the electrode position and surgery site Place the ECG electrodes as far away as possible from the surgery site and the ground plate Do not place electrodes in the path between the surgery site and the ground plate If the electrodes are placed in this path the amount of interference will be quite large Position and electro...

Page 11: ...rator due to excessive leakage current CAUTION All the peripheral device connectors on the DS 7100 system are isolated from the power supply but the peripheral devices are not isolated To prevent danger of electric shock always position the peripheral devices away from the patient When connecting peripheral devices to DS 7100 system it is the user s responsibility to verify that the overall system...

Page 12: ...se accurate measurement may not be possible Patient with excessive abnormal hemoglobin HbCO MetHb Patient with the pigment injected to the blood Patient receiving CPR treatment When measuring at site with venous pulse Patient with body motion Patient with small pulse Before the measurement make sure the patient type Adult Child Neonate is properly selected Otherwise correct measurement can not be ...

Page 13: ... the setting of telemetry channels to prevent telemetry interference The purpose of this respiration alarm is to alert the user to evaluate for the possible occurrence of apnea events by identifying the absence of respiration It is not intended to be classified as an Apnea Monitor and will not identify the condition creating the possible event Central Obstructive or Mixed CAUTION Systems The monit...

Page 14: ...tor is used during respiration monitoring a large offset voltage will be placed on the ECG electrodes which may cause interruption of monitoring for a few seconds When the following lead cables are used respiration cannot be measured Lead Cable 3380 0648 16 Electrosurgery proof 3 electrode Lead Cable 3380 0661 16 Electrosurgery proof 5 electrode SpO2 Monitoring If the nail is rough dirty or manicu...

Page 15: ...The zero balance procedure is required for the following case When starting the measurement When the position of the heart has changed due to body movement When the position of the transducer has changed When measuring for a long period of time and there is a possibility of measurement error due to change in ambient temperature etc When the connector is connected disconnected or transducer is repl...

Page 16: ...umeric data may not be transmitted The setup of channel ID and group ID should be performed only by our service representative Users should not perform this procedure as malfunction to the equipment may occur The Bed ID is factory set to 000 If connected to the wired network with the ID unchanged monitoring on the central monitor will not be possible When connecting to the wired network verify tha...

Page 17: ... only the specified IC card Restart the system after reading the setup data from the IC card The setup data will become effective after the system is restarted Maintenance Always operate the touch screen with fingers or touch screen pen Do not touch with a pen point or other hard edged instruments Malfunction of the touch screen or damage may result Do not clean the touch panel using strong acid A...

Page 18: ...y waste Precautions about Transportation For transporting the DS 7100 system pack with specified packing materials Reference Refer to 11 Technical Information Specification Performance for environmental condition during transportation Precautions about RTC or Data Backup CAUTION The DS 7100 system is equipped with a built in clock When the power of the DS 7100 system is turned off this clock is ba...

Page 19: ...he battery with any metal such as necklace hairpins etc The battery may short causing excessive current flow which may result in heating fuming explosion ignition of the battery or heating of the metal wire necklace hairpin etc Do not solder the battery directly The heat may melt the insulator or damage the security apparatus which may result in heating fuming explosion ignition of the battery Do ...

Page 20: ...gency Use 1 Battery Pack 1 The battery self discharges even when not in use If there is any possibility to use the battery in emergency the power cable should be always connected to the power receptacle To fully charge the empty battery it takes approximately 2 5 hours when the monitor is not operating and approximately 13 hours when the monitor is operating Reference Refer to 2 Basic Operation To...

Page 21: ... the room Humidify the room Lightning A lightning nearby may induce excessive voltage to the equipment If any danger is suspected use the uninterruptible power supply system High frequency noise interference from other device through the power outlet Check where the noise is originated and remove it using filtering device etc Stop using the device that is originating the noise Use other power outl...

Page 22: ...ended for use in the electromagnetic environment specified below It should be assured that the DS 7100 system is used in such an environment Immunity Test IEC60601 1 2 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC61000 4 2 3kV contact 8kV air 3kV contact 8kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic ma...

Page 23: ...ference may occur in the vicinity of equipment marked with the following symbol Note 1 At 80Mhz and 800MHz the higher frequency range applies Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless teleph...

Page 24: ... Rated Maximum Output Power of Transmitter W 26MHz 80MHz d 1 2 P 80MHz 800MHz d 1 2 P 800MHz 1GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is th...

Page 25: ...h minimum distance 20cm between the radiator and your body excluding extremities hands wrists and feet and must not be co located or operated with any other antenna or transmitter WARNING Operation of this equipment requires the prior coordination with a frequency coordinator designated by the FCC for the Wireless Medical Telemetry Service CAUTION FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON...

Page 26: ...xxvi Blank Page ...

Page 27: ...s the procedure to set the measurement condition size scale etc for each parameter 6 7 Function Describes about the functions such as arrhythmia analysis trend recall etc 7 8 System Configuration Describes about the system configuration such as night mode alarm mode display mode etc 8 9 Installation Describes about the environment for use wireless system etc 9 10 Maintenance Describes about the ma...

Page 28: ...tions for Use of SpO2 Sensor xviii Precautions for Use of NIBP Cuff xviii Disposing of Equipment Accessories or Components xviii Precautions about Transportation xviii Precautions about RTC or Data Backup xvii Precautions for Use of Lithium Ion Battery Pack xviiii To Prepare for Emergency Use xx Electromagnetic Compatibility xxi Precautions for Safe Operation under Electromagnetic Influence xxi EM...

Page 29: ...Key 14 Alarm Setup for Each Parameter 15 ON OFF of Parameter Display Waveform Numeric Data Display 16 Recording 17 Start Stop of Waveform Recording 17 To Install the Paper 18 To Suspend Monitoring 19 Discharging Procedure 20 Operation Flow 21 Chapter 3 Vital Application To Acquire ECG Waveform 2 Before Attaching the Electrodes 2 Electrode Placement 3 Connection to the Patient Monitor 4 About the A...

Page 30: ...he Recording 20 To Set the Manual Recording 20 Periodic Recording 21 Alarm Recording 22 Freeze Recording 24 Graphic Recording Graphic Tabular Trend etc 25 Recorder Operation QRS Symbol etc 26 Volume Setup Pulse Tone Alarm Sound etc 27 Color Brightness Setup 28 Color Setup Numeric Data Waveform 28 Brightness Setup 29 Telemetry Setup DS 7141 DS 7101LT 30 Transmitting Waveform Setup 32 Wired Network ...

Page 31: ... OFF of HR Synchronized Tone 8 ECG Source 9 Automatic Lead Switching 9 Pacemaker Pulse 10 QRS Pace Mask 11 ECG Drift Filter 12 ON OFF of Parameter Display 13 Respiration 14 Respiration Waveform Size 14 RR Alarm 15 Apnea Alarm 15 CVA Detection 16 Respiration Source 17 Impedance Respiration Measurement 17 RR Synchronization Mark 18 ON OFF of Parameter Display 19 Invasive Blood Pressure BP1 BP2 20 BP...

Page 32: ...nd 6 The Description of the Display 10 Tabular Trend Display Record 11 To Display the Tabular Trend 11 The Description of the Display 12 Parameter Setup for Tabular Trend 13 Recall Data Display Record 14 To Display the Recall Menu 14 Recall List Display 14 To Display and Record the Enlarged Recall Waveform 15 To Set the Recall Condition 17 OCRG Display 19 ST Display ST Display Alarm Setup etc 20 T...

Page 33: ... Set the Sweep Speed 17 Hospital Setup Setup for Each Hospital 18 About the Hospital Setup 18 AC Filter 18 Date Format 18 Alarm Mute 18 Telemetry Channel Setup DS 7141 DS 7101LT 19 Measurement Unit Setup 19 Home Key Function 19 Night Mode Cancel 19 Asystole VF VT 20 Ward Setup Setup for Each Ward 21 About the Ward Setup 21 Trend Clip 21 BP Recording Scale 21 Key Mask 22 User Key Setup 22 Alarm Pol...

Page 34: ...ling the Battery Pack 6 Handling the Battery 6 Storing the Battery 6 Maintenance Check Daily and Periodic Check 7 About the Maintenance Check 7 Daily Check 7 Periodic Check 7 Time Change Components 7 Troubleshooting 9 ECG 9 Respiration 11 Invasive Blood Pressure 11 SpO2 12 Non Invasive Blood Pressure 13 Temperature 14 CO2 Concentration 15 Recorder 16 Telemetry 16 General 17 Battery 18 Chapter 11 T...

Page 35: ...ories 2 Optional Accessories 3 ECG Impedance Respiration Measurement 3 Invasive Blood Pressure Measurement 3 Non Invasive Blood Pressure Measurement 3 Temperature Measurement 4 SpO2 Measurement 4 CO2 Concentration Measurement 4 Others 5 ...

Page 36: ...xxxvi Blank Page ...

Page 37: ...tion This chapter explains the general description of this equipment Chapter 1 General Description 2 Features 3 Names of Parts and Their Functions 4 Front Side 4 Rear Side 4 Right Side 5 Left Side 5 1 General Description ...

Page 38: ...onnection are also possible DS 7141 Function Model Type Basic Measurement CO2 Measurement BP Telemetry Transmission Ethernet LAN DS 7141 2 channels DS 7101LT 2 channels DS 7101L 2 channels NOTE The display illustration on this operation manual includes CO2 measurement but note that CO2 measurement function is not supported for the DS 7101L and DS 7101LT DS 7141 is not currently available for sales...

Page 39: ...ndard indicates the alarm by 9 flashing patterns corresponding to the alarm level All the operations are performed through the touch screen controls and up to 4 frequently used keys can be programmed as user key For the CO2 measurement a microstream method is adopted which is less influenced by the anesthetic gas DS 7141 Through the use of telemetry transmission unit a wireless network formation i...

Page 40: ...ply Connector with fuse holder Power cable is connected here Fuse is installed in the holder Equipotential Ground Terminal Equipotential ground terminal is connected here Handle Hold this part when carrying Battery Pack Holder Battery is installed here We recommend the battery to be replaced annually Power Supply Lamp Indicates the main power supply Alarm Pole Lights when the alarm generates Charg...

Page 41: ...he long term use In such case contact your nearest service representative PC Card Access Lamp Indicates the PC card access status PC Card Slot Insert only the specified PC card here Serial Connector Connect only the specified device here Status Input Connector Connect only the specified device here Speaker Generates synchronous sound key sound alarm sound Power Supply Switch Turns the monitor powe...

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