Model 101R and NR Patient Monitor Operator Manual Rev 01

Copyright © 1996 by Ivy Biomedical Systems, Inc., Branford, Connecticut. All rights reserved. No part of this manual may be reproduced without the permission of Ivy Biomedical Systems, Inc.

101NR/R0303 2409-00-16 REV 01

Table of Contents

Table of Contents WARRANTY ... iii INTRODUCTION ...1 SAFETY ...2 Electrical...2 Explosion ...2 Patient Connections...3 MRI...3 Pacemakers ...3 Electrosurgery Protection...3 Defibrillation Protection ...3 EMC...3 Disposal of Biohazard Materials ...3 Description of Labels...4 MONITOR DESCRIPTION ...5 Specifications...5 Control and Indicatiors...8 Basic Keys...8 Programmable Keys ...9 Menu Structure...10 Display ...11 Rear Panel ...11 Fuse Ratings ...12 MONITOR SETUP ...13 Change Mains Voltage ...13 TRIGGER OUTPUT...14 The Trigger Pulse ...14 Trigger-Spot Display ...14 ECG MONITORING...15 Safety Considerations...15 Patient Connections...16 ECG Waveform Amplitude (Size)...16 Lead Selection ...17 ECG Filter...17 Alarm Limits...18 RECORDER OPERATION ...19 Changing Paper ...19 Recorder Menus...20 Recorder Modes...21

Model 101R/NR Operator’s Manual

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Table of Contents

ALARM MESSAGES ...23 MONITOR TESTING ...24 CLEANING ...25 Monitor...25 Patient Cables ...25 ACCESSORIES...26 Disposal...26

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Model 101R/NR Operator’s Manual

WARRANTY

WARRANTY

All products manufactured by Ivy Biomedical Systems, Inc. are warranted to be free from defects in material and workmanship and to operate within published specifications, under normal use, for a period of one year from date of original shipment. All accessories supplied by Ivy Biomedical Systems, Inc. are warranted to be free from defects in material and workmanship and to operate within published specifications, under normal use, for a period of 90 days from date of original shipment. If an examination by Ivy Biomedical Systems, Inc. discloses such products or component parts to have been defective, then our obligation is limited to repair or replacement (at our option). Fuses are not covered under this warranty. If products need to be returned to the manufacturer for repair or examination contact customer service personnel at IVY Biomedical Systems, Inc. to obtain the Return Authorization Number (RMA) and proper packing instructions. See specifications section of this manual for environmental conditions. All returned products shall be shipped prepaid to IVY Biomedical Systems, Inc. Branford, Connecticut. USA. Ivy will ship repaired or replacement product to customers prepaid at Ivy’s expense.

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WARRANTY

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Model 101R/NR Operator’s Manual

INTRODUCTION

INTRODUCTION This manual is to provide information on the correct use of the Model 101R/NR monitor. It is up to the user to ensure that any applicable regulations respecting the installation and operation of the monitor are observed. Manufacturer's Responsibility The manufacturer of this equipment is responsible for the effects on safety, reliability, and performance of the equipment only if: •

assembly operations, extensions, re-adjustments, or repairs are carried out by persons authorized by the manufacturer

•

the electrical installation complies with all applicable regulations

•

the equipment is used in accordance with the instructions in this manual.

Incorrect operation or failure of the user to maintain the monitor in accordance with proper maintenance procedures relieves the manufacturer or his agent from all responsibility for consequent non-compliance, damage, or injury. For technical and service information, please refer to the Model 101R/NR Service Manual.

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SAFETY SAFETY

Electrical This product is intended to be operated from a mains power source of nominally 100, 120, 220 and 230V~. The correct mains operating power voltage is specified on the monitor’s rear panel. WARNING: To prevent electrical hazards to all personnel, this monitor must be properly grounded. Connect the monitor only to a three-wire, grounded, hospital grade receptacle. The three-conductor plug must be inserted into a properly wired three-wire receptacle; if a three-wire receptacle is not available, a qualified electrician must install one in accordance with the governing electric code. WARNING: Do not under any circumstances remove grounding conductor from the power plug. WARNING: The power cable supplied with this equipment provides for this protection. Do not attempt to defeat this protection by modifying the cable or by using ungrounded adapters or extension cables. The power cord and plug must be intact and undamaged. To disconnect the equipment from the mains power unplug the power cord. WARNING: Do not connect to an electrical outlet controlled by a wall switch or dimmer. WARNING: If there is any doubt about the integrity of the protective ground conductor arrangement, do not operate the monitor until the AC power source protective conductor is fully functional. WARNING: Do not place the monitor in any position that may cause it to fall on the patient. Do not lift the monitor by the power supply cord or patient cable. WARNING: Electric shock hazard! Do not remove covers or panels. Refer service to qualified service personnel. WARNING: To avoid electrical shock, disconnect the monitor from its power source before changing fuses. Replace fuses only with same type and rating (see fuse ratings). WARNING: Do not clean monitor while it is on and/or plugged into a power source. WARNING: If unit is accidentally wet, discontinue use until dry and then test unit for proper operation before reuse on a patient. WARNING: This unit uses a common isolation path for the ECG leads. Do not connect any non-isolated accessories to the ECG input when connected to a patient, as this may compromise the safety of the unit. When attached to other devices, insure that the total chassis leakage currents of all units do not exceed 300 μA.

Explosion DANGER: Explosion hazard! Do not use this equipment in the presence of flammable anesthetics or other flammable substance in combination with air, oxygen-enriched environment or nitrous oxide.

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Model 101R/NR Operator’s Manual

SAFETY

Patient Connections Patient connections are electrically isolated. For all connections use isolated probes. Don’t let patient connections contact other conductive parts, including ground. See instructions for patient connections in this manual. Carefully route patient cables to reduce the possibility of patient entanglement or strangulation. Leakage current is limited internally by this monitor to less than 10 μA. However, always consider cumulative leakage current that can be caused by other equipment used on the patient at the same time as this monitor. To ensure that the leakage current protection remains within the specifications, use only the patient cables specified in this manual. This monitor is supplied with protected lead wires. Do not use cables and leads with unprotected lead wires having exposed conductors at the cable end. Unprotected lead wires and cables may pose an unreasonable risk of adverse health consequences or death. Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. To minimize this problem, ensure proper electrode placement and cable arrangement. If an alarm condition occurs while the alarms are set to off, neither visual or audio alarms will be present.

MRI The model 101R/NR should not be used within the magnetic field during Magnetic Resonance Imaging.

Pacemakers Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely on rate meter alarms. Keep pacemaker patients under close surveillance.

Electrosurgery Protection This equipment is protected against electrosurgery potentials To avoid the potential of electrosurgery burns at monitoring sites, ensure proper connection of the electrosurgery return circuit as described by the manufacturer’s instructions. If improperly connected, some electrosurgery units might allow energy to return through the ECG electrodes.

Defibrillation Protection This equipment is protected against 360 J defibrillator discharge.. The monitor is internally protected to limit current through the electrodes to prevent injury to the patient and damage to the equipment as long as the defibrillator is used in conformance with the manufacturer’s instructions.

EMC This equipment has been certified to be protected to emissions and immunity according to IEC-60601-1-2.

Disposal of Biohazard Materials Disposal of Biohazard Materials must be done in accordance to local, state, and federal laws and regulations. NOTE: See each section for additional warnings and cautions.

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SAFETY Description of Warning Labels Attention, consult ACCOMPANYING DOCUMENTS before attempting to change power supply selection or carry out interconnections. Equipment connected should comply with IEC-601-1 or IEC-950 with configuration to IEC-601-1-1. Protective earth (ground) adjacent to this symbol. Internal connection on mains connector/filter. Equipotential earth connector adjacent to this symbol.

⎯⏐ ♥ ⏐⎯

Type CF equipment, Defibrillator proof. Fuse type/rating.

_______

{ ⏐

{ = OFF, ⏐= ON.

∼

Alternate Current (AC) Output signal.

DANGER HIGH VOLTAGE

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MONITOR DESCRIPTION

MONITOR DESCRIPTION The Model 101R/NR Portable Patient Monitor is a dual trace monitor for ECG and heart rate, which produces an output pulse corresponding in time to the R-wave. The monitor is intended primarily for use in timed imaging studies, TMR/PMR and any application requiring precision R-wave synchronization.

Specifications ECG Lead Selection:

LI, LII, LIII menu selectable.

Patient Cable:

6-Pin AAMI Standard connector

Isolation:

Isolated from ground related circuits by >4 kV rms, 5.5 kV peak

CMRR:

≥90 dB with patient cable and 51 kΩ/47 nF imbalance

Input Impedance:

≥20 MΩ at 10 Hz with patient cable

Frequency Response CRT: Frequency Response X1000 output:

Filtered: Unfiltered:

0.5 to 25 Hz 0.5 to 45 Hz

Filtered: Unfiltered:

0.5 to 25 Hz 0.2 to 100 Hz

Input Bias Current:

Any lead configuration <200 nA dc maximum

Electrode Offset Potential:

±0.5 V DC

Noise:

<20 μV peak-to-peak, referred to the input with all leads connected through 51 kΩ/47 nF to ground

Defibrillator Protection:

Protected against 360 J discharge and electrosurgery potentials

Leakage Current:

<10 μA at normal condition

Electrosurgical Interference Protection:

Standard

Notch Filter:

50/60 Hz (automatic).

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MONITOR DESCRIPTION Cardiotach Range:

15 to 255 bpm

Accuracy:

±1%

Resolution:

1 bpm

Sensitivity:

300 μV peak

Pace Pulse Rejection Width:

0.1 to 2 ms at 2 to 700 mV

Tall T Wave Rejection:

Rejects T waves ≤R wave

High Rate:

100 to 250 bpm in 5 bpm increments

Low Rate:

30 to 100 bpm in 5 bpm increments

Asystole:

R to R interval >6 seconds

Lead Off:

Detached lead or offset potential >0.5 V

Alarms

Test Mode ECG:

1 mV/100 ms @ 70 bpm

Type:

CRT, P31 phosphor, non-fade

Display

Trace:

Dual, Fixed (moving bar), single trace normal operation. Dual trace in “freeze” mode.

Screen Size:

14.25 cm by 10.2 cm, 17.5 cm diagonal

Sweep Speed:

25, 50 mm/s

Mechanical

6

Size:

Height: 6.25 in. (16 cm) Width: 12.5 in. (31 cm) Depth: 16.0 in. (40 cm)

Weight:

< 20 lbs (9 kg)

Model 101R/NR Operator’s Manual

MONITOR DESCRIPTION Trigger Output Phase Delay fromElectrode Leads to Trigger Output:

< 3 ms

R to R Trigger Accuracy:

±200 μs typical @ 1 mV input

Sensitivity and Threshold Adjustment:

Fully Automatic

Optional Trigger Delay:

User adjustable from 0 to 700 ms in 5 ms increments.

Environmental Operating Temperature Range:

5°C to 45°C

Storage Temperature Range:

-25°C to 60°C

Relative Humidity:

0-90% non-condensing

Power Requirements Voltage Input: Maximum ac Power Consumption:

100, 120, 220, 230, V ~, 50/60 Hz; +10% - 15% (to change mains operating voltage see text on Monitor Setup). 85 VA

Safety Unit meets or exceeds the specifications for the AAMI Cardiac Monitor Standard. Units meet UL544, CSA, and CE-MDD 93/42/ECC requirements. ISO-9001 Approval # 98-1044.

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MONITOR DESCRIPTION

Controls and Indicators Basic Keys MAINS POWER SWITCH: A switch to control ac power input to the monitor. The | position is on, O is off. Puts monitor into setup mode and causes setup menu to be displayed on the right portion of the screen. The monitor returns to normal mode after pressing MENU again or if no keys are pressed for 20 seconds.

Disables the audible and visual alarms for a two-minute period to allow the operator perform procedures that would otherwise set off the alarms. This avoids the problem of turning off the alarms and forgetting to turn them back on. Press this key again to return the alarms to normal before the two minutes have expired.

Generates a 1 mV pulse at 70 bpm that is displayed on the ECG trace and sent to the X1000 output on the rear panel while the switch is depressed. This is used to ensure that the monitor is functioning correctly.

Turns the alarm audio on and off. When off, the ALARMS OFF message is displayed on the left side of the screen.

Activates recorder. Push to start, push again to stop. (101R)

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Model 101R/NR Operator’s Manual

MONITOR DESCRIPTION Basic Keys

ECG Patient Cable input

Power Switch

Programmable Keys

Programmable Keys Each of the following keys, to the right of the CRT display, has a normal function, printed on the key, and two menu functions, displayed on the screen in the setup modes. The additional functions are accessed by pressing the MENU key once. Return to normal function by pressing MENU key again.

Selects the speed at which the ECG trace moves across the screen.

Stops the movement of the ECG waveform on the display for closer evaluation and displays the waveform as a second trace below the actual trace. Press FREEZE again to resume movement.

Resets the audible and visual indicators for an alarm that has been activated.

Enables the Trigger-Spot feature, which highlights the point in the ECG waveform when the trigger output pulse occurs.

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MONITOR DESCRIPTION Display HEART RATE: Displayed in beats per minute (bpm) on the upper left part of the screen. SETUP: Selections made in the menu setup modes (alarm limits, lead selection, and filter on/off) are displayed in small characters at the upper right corner. ECG: Trace is displayed across the screen moving from right to left. ALARMS: The following alarm indications are displayed in reverse video. Alarm indications appear on the upper right portion of the screen and flash once per second except ALARMS OFF, which is displayed on the upper left portion of the screen and is displayed as  .

 :

The audible alarms have been turned off.

LEAD OFF:

A lead has become disconnected. This alarm cannot be reset with the ALERT RESET key.

HR HIGH:

The high heart rate limit has been exceeded for four seconds.

HR LOW:

The low heart rate limit has been exceeded for four seconds.

ASYSTOLE:

The interval between heartbeats has exceeded six seconds.

Rear Panel The following are located on the rear panel. POWER INPUT: A receptacle for a standard ac power cord. When the monitor is connected to another piece of equipment through this rear panel connector, always make sure that each piece of connected equipment has its own separate ground connection. Do not attempt to connect cables to these connectors without contacting your Biomedical Engineering Department. This is to ensure the connection complies with leakage current requirements of one of the following applicable standards: UL 544, CSA 22.2 No. 125 or IEC 601-1. The maximum non-destructive voltage that may be applied to these connectors is 5V. TRIGGER OUTPUT: A BNC type connector for the output of the trigger pulse indicating the timing of the peak of the R-wave. The output can be delayed from the peak of the R-wave through user controls. QRS VOLUME CONTROL: A switch to control the QRS beep audio volume. Alarm audio is not affected. PEQ GROUND: Potential Equalization - A ground connection that can be used to ensure that no potential differences can develop between this equipment and other electrical equipment. FUSE: Replace only with the same type and rating of fuse as indicated on the fuse rating on page 12. ECG X1000: This is an ECG analog wave output.

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MONITOR DESCRIPTION REFERS TO OPERATOR'S MANUAL

ECG

X 1000

ECG Output QRS VOLUME MAX OFF

PHYS. TRIG. OUTPUT TRIGGER POLARITY NEG POS

(¼" stereo jack) Tip=ECG X1000

QRS Volume Control PEQ Ground

MIN

Trigger Output/BNC Selects Output Trigger Polarity

120 Vac

Voltage Selection wheel Fuse (Beneath Panel) Power Input

85VA 50/60Hz

Fuse Ratings Fuse ratings 100V ⏐ 120V T 1.6 Amp 250V 5mm x 20mm

12

220V ⏐ 230V T 1.0 Amp 250V 5 mm x 20 mm

Model 101R/NR Operator’s Manual

MONITOR SETUP

MONITOR SETUP

To setup the instrument for operation: 1.

Plug the ac line cord into a power source providing the proper voltage.

Check the monitor's rear panel to verify the voltage range required by the monitor. 2.

Press the POWER switch at the left side of the front panel to turn power on.

3.

Connect the patient cable to the ECG connector on the front panel.

4.

Connect the Trigger Output from the monitor rear panel to the device being triggered.

To change Mains Voltage: 1.

Locate power entry module in Rear Panel.

2.

Remove line cord.

3.

Pry down entry cover.

4.

Locate and remove voltage wheel and set for appropriate voltage.

5.

Replace fuse with proper size (see fuse rating).

6.

Replace cover.

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TRIGGER OUTPUT

TRIGGER OUTPUT The Trigger Pulse The ECG Trigger Output produces a 100 ms, 0 - 5 V trigger pulse starting at the peak of each R-wave, which is available on the TRIGGER OUTPUT BNC connector on the rear panel of the monitor. The following shows the timing of the trigger pulse compared to the ECG waveform.

Trigger-Spot Display Press the TRIG MARK key on the front panel to highlight the portion of the ECG waveform corresponding to the timing of the trigger pulse. Press TRIG MARK again to disable Trigger-Spot.

Optional Trigger Delay Trigger delay is user adjustable by using the Trigger Delay menu. Range is from 0 to 700 ms in 5 ms increments.

Intensity modulation highlights position of ECG where delay occurs.

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Model 101R/NR Operator’s Manual

ECG MONITORING

ECG MONITORING

When ECG monitoring, the display shows the ECG waveform across the center; the heart rate, heart rate limits, and lead selection in the upper left corner; and alarm indications. Also, a heart symbol flashes each time a heartbeat is detected.

Safety Considerations

Disposable products are intended for single-use only. Do not attempt to re-use these products. Patient connections are electrically isolated Type CF ⎯⏐ ♥ ⏐⎯. For all connections use insulated probes. Don't let patient connections contact other conductive parts, including earth. See instructions for patient connections in this manual. Leakage current is limited internally by this monitor to less than 10 μA. However, always consider additional leakage current that can be caused by other equipment used on the patient at the same time as this monitor. Avoid electrosurgery burns at monitoring sites by ensuring proper connection of the electrosurgery return circuit. If improperly connected, some electrosurgery units might allow energy to return through the electrodes. Rate meters might continue to count the pacemaker rate during occurrences of cardiac arrest or some arrhythmias. Do not rely on rate meter alarms. Keep pacemaker patients under close surveillance.

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