WEP-4204 - 4208 Operator’s Manual

Model:

WEP-4204/4208J/K

Manual code no.: 0614-006019C

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CONTENTS

Contents GENERAL HANDLING PRECAUTIONS ... i WARRANTY POLICY ... ii EMC RELATED CAUTION ... iii Conventions Used in this Manual and Instrument ... v Warnings, Cautions and Notes ... v Explanations of the Symbols in this Manual and Instrument ... vi On panel ... vi On screen ... vii

Section 1

General ... 1C.1 Introduction ... 1.1 Features ... 1.1 Transmitters and Available Parameters ... 1.3 Composition ... 1.5 Panel Descriptions ... 1.6 Front Panel ... 1.6 Left Side Panel ... 1.7 Right Side Panel ... 1.8 Rear Panel ... 1.8 Types of Screens ... 1.9 Basic Operating Concepts ... 1.17 Using Touch Screen Keys ... 1.17 Keys on the Front Panel ... 1.18 Using Function Dials ... 1.19 Using MENU Screen ... 1.19 General Safety Information ... 1.20 General ... 1.20 Installation ... 1.21 Recording ... 1.22 Network ... 1.23 Operation and Monitoring ... 1.24 Transmitter ... 1.24 Battery in the Transmitter ... 1.26 ECG Monitoring ... 1.26 Respiration Monitoring ... 1.27 SpO2 Monitoring ... 1.28 NIBP Monitoring ... 1.30 IBP Monitoring ... 1.31 Temperature Monitoring ... 1.31 CO2 Monitoring ... 1.32 TG-900P CO2 Sensor Kit ... 1.32 TG-950P CO2 Sensor Kit ... 1.32 Airway Adapter ... 1.33 Maintenance ... 1.33

Section 2

Preparation ... 2C.1 Preparation Flowchart ... 2.1 Installation Conditions ... 2.2

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C.1

CONTENTS Attaching Antennas ... 2.4 Attaching Name Plate ... 2.5 Attaching Name Label (WEP-4208 only) ... 2.5 Attaching Touch Pen ... 2.6 Loading the Recording Paper ... 2.7 Connecting an External Instrument ... 2.9 Connecting the Instrument to a Network ... 2.10 Installing the Optional Network Card ... 2.11 Installing the Optional Network Printer Card ... 2.12 Removing the Optional Network Card or Network Printer Card ... 2.12 Connecting the Power Cord and Grounding the Instrument ... 2.13 Connecting the Power Cord ... 2.13 Grounding the Instrument ... 2.13 Turning the Power On or Off ... 2.14 Check Before Turning On the Power ... 2.14 Turning the Power On ... 2.14 Check After Turning On the Power and During Monitoring ... 2.15 Turning Off the Power ... 2.15 Checks After Turning Off the Power ... 2.16 Preparing the Transmitters ... 2.16

Section 3

Changing System Setup Settings ... 3C.1 Displaying the SYSTEM SETUP Screen ... 3.2 Changing Settings ... 3.3 Closing the SYSTEM SETUP Screen and Displaying the All Beds Screen ... 3.3 List and Explanation of the SYSTEM SETUP Settings ... 3.4 List of All Settings ... 3.4 Display Settings (DISPLAY SETUP) ... 3.5 Host and Bed ID Setting (BED ID SETUP) ... 3.7 Unit Settings (UNITS SETUP) ... 3.8 Alarm Settings (ALARM SETUP) ... 3.8 Recording Settings (RECORD SETUP) ... 3.11 Sound Settings (SOUND SETUP) ... 3.12 Color Settings (COLOR SETUP) ... 3.12 Option Setting (OPTION SETUP) ... 3.14 Alarm Master Settings (ALARM MASTER) ... 3.15 Arrhythmia Recall Master Settings (ARRHYTHMIA RECALL MASTER) ... 3.16 Channel Group Setting (CHANNEL GROUP) ... 3.17 Selecting Channels (SELECT CHANNEL) ... 3.17 Alarm Indicator Setting (ALARM INDICATOR) ... 3.20 Other Settings (OTHER SETUP) ... 3.20 RS-232C Communication Settings (PC SETUP) ... 3.21 Network Settings (NETWORK SETUP) ... 3.22 Network Printer Settings (PRINTER SETUP) ... 3.23 Initializing the System ... 3.25 List of Factory Default Settings ... 3.26 ECG Screen ... 3.26 RESP Screen ... 3.26 SpO2 Screen ... 3.26 PRESS Screen ... 3.26 CO2 Screen ... 3.26 TREND Screen ... 3.27 LIST Screen ... 3.27

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Operator’s Manual WEP-4204/4208

CONTENTS ARRHYTH RECALL Screen ... 3.28 ARRHYTHMIA ALARM Screen ... 3.28 VITAL ALARM Screen ... 3.29 RECORDING Screen ... 3.30 DISPLAY Screen ... 3.30 DATE&TIME Screen ... 3.30 SOUND screen ... 3.31 FUNCTION KEY Screen ... 3.31 BRIGHT Screen ... 3.31 FULL DISCLOSURE Screen ... 3.31 NO. OF PATIENTS Screen (WEP-4208 only) ... 3.31 SYSTEM SETUP Screen ... 3.31

Section 4

Necessary Settings Before Monitoring ... 4C.1 Changing Date and Time ... 4.1 Changing Sound Settings ... 4.3 Displaying the SOUND Screen ... 4.3 Selecting Bed for Sync Sound ... 4.4 Changing the Synchronous Sound Volume and Alarm Sound Volume ... 4.5 Changing the Screen Brightness ... 4.6 Assigning a Function to the Function Key ... 4.7 Admitting or Discharging Patient ... 4.9 Displaying the ADMIT/DISCHARGE Screen ... 4.9 Entering the Patient Information to Admit Patient ... 4.11 Entering the Patient Name ... 4.11 Entering the Date of Birth and Age ... 4.12 Entering the Sex ... 4.13 Entering the Patient ID ... 4.13 Discharging the Patient ... 4.14 Changing the Transmitter and Receiving Channel Number ... 4.15 Changing the Number of Monitored Patients (WEP-4208 only) ... 4.19 Cautions for Decreasing the Number of Monitored Patients ... 4.19 Procedure ... 4.20

Section 5

Monitoring Waveforms and Data ... 5C.1 Safety Precautions for Monitoring ... 5.1 Overview ... 5.2 Monitoring Screens ... 5.2 Review Screens ... 5.2 Sync Sound ... 5.3 Waveform Display ... 5.3 Changing Settings and Performing Other Tasks During Monitoring ... 5.3 Pausing Monitoring ... 5.3 All Beds Screen ... 5.4 WEP-4208 All Beds Screen ... 5.4 Type A Mode ... 5.5 Type B Mode ... 5.5 Changing All Beds Screen Display Settings ... 5.6 WEP-4204 All Beds Screen ... 5.9 Rows Mode ... 5.10 Columns Mode ... 5.11 Changing All Beds Screen Display Settings ... 5.12

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C.3

CONTENTS Personal Display Screen ... 5.16 WEP-4208 Personal Display Screen ... 5.16 WEP-4204 Personal Display Screen ... 5.17 Review Screens ... 5.19 Trend Screen ... 5.19 Displaying the TREND Screen ... 5.21 Selecting Parameters for the Multi-parameter Trendgraph ... 5.23 Changing the Time Threshold for Apnea Trendgraph ... 5.23 Recording the Trendgraph ... 5.24 Printing the Trendgraph ... 5.24 List Screen ... 5.26 Displaying the LIST Screen ... 5.27 Setting the List Interval for the Periodic Vital Signs List ... 5.29 Selecting Parameters to be Displayed on the LIST Screen ... 5.29 Recording a List ... 5.29 Printing a List ... 5.30 Arrhythmia Recall Screen ... 5.31 Arrhythmia List ... 5.32 Arrhythmia Waveform Annotation ... 5.33 Displaying the Arrhythmia Recall List Screen ... 5.33 Recording the Arrhythmia Recall List ... 5.35 Displaying the Actual Size Waveform of the Selected Arrhythmia Recall File ... 5.35 Recording the Arrhythmia Recall Waveform ... 5.36 Printing the Arrhythmia Recall Waveform ... 5.36 Selecting the Arrhythmia Types to be Saved as a Recall File ... 5.37 Full Disclosure Screen ... 5.38 Selecting Bed for Saving Full Disclosure ... 5.39 Setting the Full Disclosure Waveform Range for Printing ... 5.42 Displaying the FULL DISCLOSURE Screen ... 5.42 Recording the Full Disclosure Waveform ... 5.44 Printing the Full Disclosure Waveform ... 5.44 Displaying the Actual Size Waveform of the Full Disclosure Waveform ... 5.45 Recording the Actual Size ECG Waveform ... 5.46 Printing the Actual Size Waveform ... 5.46 Freezing Waveforms ... 5.47 Pausing Monitoring ... 5.48 Calibrating Waveforms ... 5.49

Section 6 Alarm Function ... 6C.1 Overview of Alarms ... 6.1 What is an Alarm ... 6.1 Alarm Level ... 6.1 Silencing an Alarm ... 6.1 Alarm Master ... 6.2 Automatic Recording ... 6.2 Alarm Setting ... 6.2 Using a ZB-800P/ZB-900P Transmitter Attached to a Bedside Monitor ... 6.2 Adjusting Alarm Sound Volume ... 6.2 Alarm Types ... 6.3 Vital Signs Alarms ... 6.3 Vital Signs Alarm Type ... 6.3 Arrhythmia Alarms ... 6.3 Arrhythmia Alarm Type ... 6.4

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Operator’s Manual WEP-4204/4208

CONTENTS Parameter Alarms ... 6.4 Parameter Alarm Type ... 6.4 Other Alarms ... 6.5 Other Alarm Type ... 6.5 Messages ... 6.5 Alarm Indications ... 6.6 Individual Alarm Indications ... 6.7 Vital Signs Alarms ... 6.7 Arrhythmia Alarms ... 6.7 Parameter Related Alarms ... 6.8 Other Alarms ... 6.10 Alarm Displaying Priority ... 6.11 Alarm Message Display Area ... 6.11 Alarm Control Marks ... 6.12 Alarm Suspend Mark ... 6.12 Alarm Recording Off Mark ... 6.12 Individual Vital Signs Alarm Off Marks ... 6.12 Priority of Alarm Control Marks ... 6.12 Adjusting the Alarm Sound Volume ... 6.12 Temporarily Silencing Alarms ... 6.13 Silencing Alarm ... 6.13 Canceling Alarm Silence ... .6.13 Suspending Alarm Before Occurrence ... 6.13 Turning Automatic Alarm Recording On or Off ... 6.14 Setting Alarm Limits ... 6.16 Overview ... 6.16 Alarm Limits Ranges ... 6.16 Vital Signs Alarms ... 6.16 Arrhythmia Alarms ... 6.17 Setting Vital Signs Alarm Individually ... 6.17 Setting Vital Signs Alarms to a Preset Pattern (Alarm Master) ... 6.19 Setting Arrhythmia Alarms Individually ... 6.21 Setting All Arrhythmia Alarms to a Preset Pattern ... 6.23

Section 7 Recording ... 7C.1 Overview of Recording ... 7.1 Recording Modes (with the Thermal Array Recorder) ... 7.2 Call Recording ... 7.3 Recording Mode Annotations ... 7.3 Recording Priority ... 7.3 Recording/Printing Sensitivity ... 7.4 Recording Speed ... 7.4 Recorded Data with the Thermal Array Recorder ... 7.4 Printing Modes (with a network Printer) ... 7.5 Printed Data with a Network Printer ... 7.5 Changing the Recording Pattern ... 7.6 Manually Recording Waveforms ... 7.8 Setting Periodic Recording ... 7.9 Changing Settings for Periodic Recording ... 7.9 All Waveform Printing ... 7.12

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CONTENTS

Section 8

Changing Parameter Settings ... 8C.1 Monitoring ECG ... 8.2 Preparation Flowchart ... 8.2 ECG Information on the Screen ... 8.3 Measuring ST Level ... 8.4 Monitoring Arrhythmia ... 8.5 Arrhythmia Analysis Classification Messages ... 8.6 Learning the ECG Waveform for Arrhythmia Detection (VPC Learning) ... 8.6 Changing the Dominant QRS ... 8.8 Noise Detection and Display ... 8.10 Detached Electrode Detection and Display ... 8.10 Changing the ECG Settings ... 8.10 Selecting the Appropriate ECG Lead ... 8.10 Changing the Lead ... 8.11 Changing the ECG Sensitivity ... 8.12 Changing the Heart Rate Alarm Limits ... 8.13 Changing the Arrhythmia Alarm Setting ... 8.14 Turning the Filter On or Off ... 8.16 Turning Pacing Spike Detection On or Off ... 8.17 Turning Arrhythmia Analysis On or Off ... 8.19 Changing the Sync Source ... 8.20 Turning the ECG Measurement On or Off ... 8.22 Monitoring Respiration ... 8.24 Selecting Impedance or Thermistor Respiration Measurement ... 8.24 Impedance Method ... 8.24 Thermistor Method ... 8.25 Measurement Method Priority ... 8.25 Preparation Flowchart ... 8.25 Impedance Method ... 8.25 Thermistor Method ... 8.25 Respiration Information on the Screen ... 8.26 Changing the Respiration Settings ... 8.28 Turning Respiration Monitoring On or Off ... 8.28 Changing the Respiration Waveform Sensitivity ... 8.29 Changing the Apnea Alarm Limit ... 8.29 Changing the Respiration Alarm Limits ... 8.30 Turning Respiration Measurement On or Off ... 8.32 Changing the Respiration Waveform Sweep Speed ... 8.33 Monitoring SpO2 ... 8.35 Preparation Flowchart ... 8.36 SpO2 Information on the Screen ... 8.36 Detection and Display of Measurement Condition ... 8.38 CHECK PROBE Message (When the Finger Probe is Used) ... 8.38 DETECTING PULSE Message ... 8.39 Changing SpO2 Settings ... 8.39 Changing the Pulse Waveform Sensitivity ... 8.39 Changing the SpO2 Alarm Limits ... 8.40 Changing the Sync Source ... 8.41 Selecting Variable or Fixed Pitch of Sync Sound ... 8.42 Monitoring NIBP ... 8.45 Preparation Flowchart ... 8.46 NIBP Information on the Screen ... 8.47 Changing the NIBP Alarm Limits ... 8.48

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Operator’s Manual WEP-4204/4208

CONTENTS Monitoring IBP ... 8.50 Preparation Flowchart ... 8.50 IBP Information on the Screen ... 8.50 Changing the IBP Settings ... 8.52 Changing the IBP Scale ... 8.52 Changing the IBP Alarm Limits ... 8.54 Changing the Sync Source ... 8.55 Selecting Variable or Fixed Pitch of Sync Sound ... 8.56 Monitoring Temperature ... 8.58 Preparation Flowchart ... 8.58 Temperature Information on the Screen ... 8.58 Changing the Temperature Alarm Limits ... 8.60 Changing the Temperature Setting ... 8.62 Monitoring CO2 ... 8.63 Preparation Flowchart ... 8.64 CO2 Sensor Kit and Airway Adapter ... 8.65 Connecting the CO2 Sensor Kit to a Respiration Circuit ... 8.65 Inspection of Measuring Accuracy ... 8.65 CO2 Information on the Screen ... 8.66 Changing CO2 Settings ... 8.67 Changing the CO2 Waveform Scale ... 8.67 Changing the Respiration Rate Alarm Limits ... 8.67 Changing the Apnea Alarm Limit ... 8.68 Changing the CO2 Alarm Limit ... 8.68 Changing the Respiration Waveform Sweep Speed ... 8.69

Section 9

Error Messages and Troubleshooting ... 9C.1 Monitoring ... 9.1 Messages ... 9.1 Problems ... 9.2 Network ... 9.3 Message ... 9.3 Problems ... 9.3 ECG Monitoring ... 9.4 Messages ... 9.4 Problems ... 9.5 Respiration Monitoring ... 9.6 Messages ... 9.6 Problems (Impedance Method) ... 9.6 Problems (Thermistor Method) ... 9.6 SpO2 Monitoring ... 9.7 NIBP Monitoring ... 9.8 IBP Monitoring ... 9.8 Temperature Monitoring ... 9.9 CO2 Monitoring ... 9.9 Recording ... 9.10

Section 10 Maintenance... 10C.1 Calibrating the Touch Screen ... 10.2 Cleaning the Touch Screen ... 10.4 Turning Touchkey Function On or Off ... 10.4 Cleaning the Touch Screen ... 10.5

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C.7

CONTENTS Cleaning and Disinfecting the Instrument ... 10.6 Cleaning ... 10.6 Disinfecting ... 10.6 Cleaning the Recorder ... 10.7 Cleaning the Thermal Head ... 10.7 Cleaning the Sensors ... 10.7 Yearly Inspection ... 10.8 Clock Accuracy ... 10.9 Repair Parts Availability Policy ... 10.9

Section 11 Reference ... 11C.1 Specifications ... 11.1 Receiver ... 11.1 Display ... 11.1 Alarm ... 11.1 ECG Monitoring ... 11.1 Respiration Monitoring ... 11.2 SpO2 Monitoring ... 11.2 Non-invasive Blood Pressure Monitoring ... 11.2 Invasive Blood Pressure Monitoring ... 11.2 CO2 Monitoring ... 11.2 Temperature Monitoring ... 11.2 Pulse Rate Monitoring ... 11.2 Arrhythmia and Arrhythmia Waveform Storage (Recall files) ... 11.3 Trendgraph ... 11.3 Vital Signs List ... 11.3 Full Disclosure ... 11.3 Recording ... 11.3 External Output ... 11.3 Transmitter ZB-800P/810P/811P/820P/821P/822P/823P/831P/860P /900P/910P/920P/930P/ZS-900P ... 11.4 Power Requirements ... 11.4 Clock Accuracy ... 11.4 Environment ... 11.4 Dimensions and Weight (approximate) ... 11.4 Electromagnetic Compatibility ... 11.4 Safety Standards ... 11.5 Output Socket Pin Assignment ... 11.6 AUX Socket ... 11.6 General Requirement for Connecting Medical Electrical System ... 11.7 Standard Accessories ... 11.9 Options/Consumables ... 11.9 Channel Setting for a Group of Monitors in the Same Area ... 11.10 Channels ... 11.10 Channel Group ... 11.10 Channel Zone and Interference ... 11.11 Free Setting ... 11.12 Channel Interference ... 11.13

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Operator’s Manual WEP-4204/4208

GENERAL HANDLING PRECAUTIONS This device is intended for use only by qualified medical personnel. Use only Nihon Kohden approved products with this device. Use of non-approved products or in a non-approved manner may affect the performance specifications of the device. This includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, input boxes and AC power. Please read these precautions thoroughly before attempting to operate the instrument. 1. To safely and effectively use the instrument, its operation must be fully understood. 2. When installing or storing the instrument, take the following precautions: (1) Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures, poorly ventilated areas, and dust, saline or sulphuric air. (2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport. (3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage. (4) The power line source to be applied to the instrument must correspond in frequency and voltage to product specifications, and have sufficient current capacity. (5) Choose a room where a proper grounding facility is available. 3. Before Operation (1) Check that the instrument is in perfect operating order. (2) Check that the instrument is grounded properly. (3) Check that all cords are connected properly. (4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other problems. (5) All circuitry used for direct patient connection must be doubly checked. (6) Check that battery level is acceptable and battery condition is good when using battery-operated models. 4. During Operation (1) Both the instrument and the patient must receive continual, careful attention. (2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety. (3) Avoid direct contact between the instrument housing and the patient. 5. To Shutdown After Use (1) Turn power off with all controls returned to their original positions. (2) Remove the cords gently; do not use force to remove them. (3) Clean the instrument together with all accessories for their next use. 6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order. 7. The instrument must not be altered or modified in any way. 8. Maintenance and Inspection: (1) The instrument and parts must undergo regular maintenance inspection at least every 6 months. (2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition.

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(3) Technical information such as parts list, descriptions, calibration instructions or other information is available for qualified user technical personnel upon request from your Nihon Kohden distributor. 9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or location of electrodes and/or transducers to avoid possible burn to the patient. 10. When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage.

WARRANTY POLICY Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from the warranty. NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period, provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals. No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any other warranty, either implied or in writing. In addition, service, technical modification or any other product change performed by someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty. Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure. Shipping costs must be pre-paid. This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism, water or other casualty, improper installation or application, or on which the original identification marks have been removed. In the USA and Canada other warranty policies may apply.

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Operator's Manual WEP-4204/4208

EMC RELATED CAUTION This equipment and/or system complies with the International Standard IEC 60601-1-2 for electromagnetic compatibility for medical electrical equipment and/or system. However, an electromagnetic environment that exceeds the limits or levels stipulated in the IEC 60601-1-2, can cause harmful interference to the equipment and/or system or cause the equipment and/or system to fail to perform its intended function or degrade its intended performance. Therefore, during the operation of the equipment and/or system, if there is any undesired deviation from its intended operational performance, you must avoid, identify and resolve the adverse electromagnetic effect before continuing to use the equipment and/or system. The following describes some common interference sources and remedial actions: 1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station or cellular phone: Install the equipment and/or system at another location if it is interfered with by an emitter source such as an authorized radio station. Keep the emitter source such as cellular phone away from the equipment and/or system. 2. Radio-frequency interference from other equipment through the AC power supply of the equipment and/or system: Identify the cause of this interference and if possible remove this interference source. If this is not possible, use a different power supply. 3. Effect of direct or indirect electrostatic discharge: Make sure all users and patients in contact with the equipment and/or system are free from direct or indirect electrostatic energy before using it. A humid room can help lessen this problem. 4. Electromagnetic interference with any radio wave receiver such as radio or television: If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or system as far as possible from the radio wave receiver. If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden Corporation subsidiary or distributor for additional suggestions.

The CE mark is a protected conformity mark of the European Community. The products herewith comply with the requirements of the Medical Device Directive 93/42/EEC. The CE mark only applies to the WEP-4204/4208K Telemetry System. This equipment complies with International Standard IEC 60601-1-2 (1993) which requires CISPR11, Group 1, Class B. Class B EQUIPMENT is equipment suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.

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In IEC 60601-1-2 Medical Electronic Equipment, Part 1: General Requirements for Safety, 2. Collateral Standard: Electromagnetic compatibility-Requirements and test. Section 36. 202. 2 Radiated radiofrequency electromagnetic fields, PATIENT COUPLED EQUIPMENT and/or SYSTEMS applicable IMMUNITY test methods are under consideration at SC62A/WG13. The 3 V/m IMMUNITY level may be inappropriate especially when measuring SpO2 because physiological signals can be much smaller than those induced by a 3 V/m electromagnetic field. When measuring SpO2, various interference may produce false waveforms which look like pulse waveforms. SpO2 value and pulse rate may be measured from these false waveforms, causing the alarm to function improperly. When installing the monitor, avoid locations where the monitor may receive strong electromagnetic interference such as radio or TV stations, cellular phone or mobile two-way radios.

WARNING Interaction Between Minute Ventilation Rate-Adaptive Pacemakers and Cardiac Monitoring and Diagnostic Equipment* The bioelectric impedance measurement sensor of a minute ventilation rate-adaptive implantable pacemaker may be affected by cardiac monitoring and diagnostic equipment which is connected to the same patient. If this occurs, the pacemaker may pace at its maximum rate and give incorrect data to the monitor or diagnostic equipment. If this occurs, disconnect the monitor or diagnostic equipment from the patient or change the setting on the pacemaker by referring to the pacemaker’s manual. For more details, contact your pacemaker distributor or Nihon Kohden distributor.

* Minute ventilation is sensed in rate-adaptive pacemakers by a technology known as bioelectric impedance measurement (BIM). Many medical devices in addition to pacemakers use this technology. When one of these devices is used on a patient with an active, minute ventilation rate-adaptive pacemaker, the pacemaker may erroneously interpret the mixture of BIM signals created in the patient, resulting in an elevated pacing rate. For more information, see the FDA web site. http://www.fda.gov/cdrh/safety.html

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Operator's Manual WEP-4204/4208

Conventions Used in this Manual and Instrument Warnings, Cautions and Notes Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information.

WARNING A warning alerts the user to the possible injury or death associated with the use or misuse of the instrument.

CAUTION A caution alerts the user to possible injury or problems with the instrument associated with its use or misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other property.

NOTE A note provides specific information, in the form of recommendations, prerequirements, alternative methods or supplemental information.

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Explanations of the Symbols in this Manual and Instrument The following symbols found in this manual/instrument bear the respective descriptions as given. On panel Symbol

Description

Description

Standby lamp

Equipotential terminal

“On” only for a part of instrument

Alternating current

“Off” only for a part of instrument

Year of manufacture

Alarm suspend

Serial number

Record start/stop

Input/output terminal

Out of paper

Remote terminal

Attention, consult operator’s manual

High voltage

Data input/output

Protective earth

All beds

Menu

vi

Symbol

The CE mark is a protected conformity mark of the European Community. The products herewith comply with the requirements of the Medical Device Directive 93/42/EEC.

Operator's Manual WEP-4204/4208

On screen Symbol

Description

Symbol

Description

Low battery

QRS/pulse sync mark

Alarm suspend with remaining minutes

Respiration sync mark

Alarm suspended on transmitter

Value out of range

Alarm off

Current setting

Alarm recording off

Increment/decrement, adjust setting

Paper magazine open

Touch screen calibration mark

Out of paper

Printer (when QI-111P network printer card is used)

Recording

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Section 1 General

Introduction ... 1.1 Features ... 1.1 Transmitters and Available Parameters ... 1.3 Composition ... 1.5 Panel Descriptions ... 1.6 Front Panel ... 1.6 Left Side Panel ... 1.7 Right Side Panel ... 1.8 Rear Panel ... 1.8 Types of Screens ... 1.9 Basic Operating Concepts ... 1.17 Using Touch Screen Keys ... 1.17 Keys on the Front Panel ... 1.18 Using Function Dials ... 1.19 Using MENU Screen ... 1.19 General Safety Information ... 1.20 General ... 1.20 Installation ... 1.21 Recording ... 1.22 Network ... 1.23 Operation and Monitoring ... 1.24 Transmitter ... 1.24 Battery in the Transmitter ... 1.26 ECG Monitoring ... 1.26 Respiration Monitoring ... 1.27 SpO2 Monitoring ... 1.28 NIBP Monitoring ... 1.30 IBP Monitoring ... 1.31 Temperature Monitoring ... 1.31 CO2 Monitoring ... 1.32 TG-900P CO2 Sensor Kit ... 1.32 TG-950P CO2 Sensor Kit ... 1.32 Airway Adapter ... 1.33 Maintenance ... 1.33 Operator's Manual WEP-4204/4208

1C.1

1. GENERAL

Introduction The WEP-4204/4208J/K Telemetry System is designed to be used in the ICU, CCU, recovery room and general ward. It can simultaneously monitor up to 8 patients (WEP-4208) or 4 patients (WEP-4204) in various locations using radio telemetry. The telemetry system monitors single/dual lead ECG, impedance and thermistor respiration, 2-channel temperature, SpO2, non-invasive blood pressure, invasive blood pressure and CO2 depending on the transmitter or bedside monitor used. To achieve full performance thoroughly read this operator’s manual in conjunction with the transmitters and bedside monitor operator’s manuals before operating the instrument. For simplicity, the suffix J/K will be omitted in this manual. There is no difference in operation among models with different suffixes unless otherwise specified. Screens in this manual are basically those of WEP-4208. Screens of WEP-4204 are used when necessary.

NOTE • WEP-4208J/K telemetry systems with serial number before 10000 cannot monitor invasive blood pressure. For those monitors, do not refer to invasive blood pressure section in this operator’s manual. • Use only Nihon Kohden parts and accessories to assure maximum performance from your instrument.

Features

Operator's Manual WEP-4204/4208

• WEP-4208: Up to 8 patients’ ECG trace with respiration, IBP, pulse or CO2 waveform can be displayed on the 12.1 inch color wide angle LCD. There are two modes for displaying the All Beds screen. Type A mode: Displays about 7.4 seconds of one ECG trace and numerical data of other monitoring parameters. Suitable for viewing a long waveform. Type B mode: Displays about 5 seconds of one ECG trace and numerical data of other monitoring parameters. Suitable for viewing numbers in large size. WEP-4204: Up to 4 patients’ ECG trace with respiration, IBP, pulse or CO2 waveform can be displayed on the 12.1 inch color wide angle LCD. There are two modes for displaying the All Beds screen. Rows mode: Displays patients’ information in rows. ECG trace with respiration, IBP, pulse or CO2 waveform can be displayed. Dual ECG can also be displayed. Column mode: Displays patients’ information in columns. ECG trace can be cascaded with ECG and other monitoring parameters in numerical data. Heart rate, blood pressure, SpO2 and respiration rate trendgraph of one patient can also be displayed. 1.1

1. GENERAL • There are review screens to display more information on a patienttrend screen (single parameter trendgraph and 24 hour of HR and up to 3 parameters for multi-parameter trendgraph), list screen (up to 120 measurements for each patient) and arrhythmia recall screen (up to 128 files (WEP-4208) or 64 files (WEP-4204), total for all patients, with QM-421P flash disk card, 1024 files). With the optional QM-421P flash disk card, the full disclosure screen is available. • Arrhythmia can be analyzed and ST level can be measured. • The instrument can be operated using touch keys on the screen. • There is three soft keys to which a function can be assigned by the operator for changing screens. • Data can be recorded by the built-in 3-channel thermal array recorder, or printed by a network printer. • With the optional QI-102P network card, vital sign data can be sent to a central monitor through the network. With the optional QI-111P network printer card, vital sign data can be printed by a network printer.

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Operator's Manual WEP-4204/4208