INSTRUCTIONS FOR USE
Notice
About This Edition
Publication number
M4992-91150
Edition 1
Copyright
2004 Koninklijke Philips Electronics N.V. All rights are reserved.
All other product names are the property of their respective owners.
Permission is granted to copy and distribute this document for educational purposes.
Warranty
Philips Medical Systems makes no warranty of any kind with regard to this material, including, but not limited to, the implied warranties or merchantability and fitness for a particular purpose.
Philips Medical Systems shall not be liable for errors contained herein or for incidental or consequential damages in connection with the furnishing, performance, or use of this material.
WARNING
As with electronic equipment, Radio Frequency
(RF) interference between the cardiograph and any existing RF transmitting or receiving equipment at the installation site, including electrosurgical equipment, should be evaluated carefully and any limitations noted before the equipment is placed in service.
Radio frequency generation from electrosurgical equipment and close proximity transmitters may seriously degrade performance.
WARNING
Like all electronic devices, this cardiograph is susceptible to electrostatic discharge (ESD). Electrostatic discharge typically occurs when electrostatic energy is transferred to the patient, the electrodes, or the cardiograph.
ESD may result in ECG artifact that may appear as narrow spikes on the cardiograph display or on the printed report. When ESD occurs, the cardiograph ECG interpretation may be inconsistent with the physician interpretation.
Philips Medical Systems assumes no liability for failures resulting from RF interference between Philips Medical Systems medical electronics and any radio frequency generating equipment at levels exceeding those established by applicable standards.
CAUTION
The use of parts or accessories other than those approved by Philips Medical Systems may compromise product performance.
United States federal law restricts this device to use by or on the order of a physician.
THIS PRODUCT IS NOT INTENDED FOR HOME USE.
Medical Device
Directive
The PageWriter Trim Cardiograph complies with the requirements of the Medical Device Directive 93/42/EEC and carries
the 0123 mark accordingly.
Authorized EU-represen- tative:
Philips Medizinsysteme
Böblingen GmbH
Hewlett Packard Str. 2
71034 Böblingen
Germany
Contents
Safety Summary
Safety Symbols Marked on the Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i Safety Symbols Marked on the Cardiograph Packaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii Conventions Used in the Instructions for Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii Important Patient and Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii The PageWriter Trim Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi
Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii The Philips 12-Lead Algorithm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Intended Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Getting Started
PageWriter Trim Cardiograph Learning Kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 About the PageWriter Trim Learning Kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2 Attaching the Cardiograph to the Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3 PageWriter Trim I Cardiograph Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-5 PageWriter Trim II and III Cardiograph Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-7 Installing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9 Battery Charging Indicator, PageWriter Trim II and III . . . . . . . . . . . . . . . . . . . . . 1-10 Battery Charging Indicator, PageWriter Trim I . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10 Loading the Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 Tips for loading printer paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11 Patient Interface Module (PIM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-12 Inserting the Lead Wires into the PIM. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-13 Connecting the PIM to the Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-14 Placing the PIM in the Holder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15 Using the PC Card Slot. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 Using the PC Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16 Using the Modem Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17 Using the LAN Card. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-17 Inserting or Removing a PC Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18 Using the Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-18 Using the Magnetic Card Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19 Using the SmartCard Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-19 Powering On the Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-20 Using the On/Standby Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-21 Using the Trim Knob. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-22
Contents-1
PageWriter Trim I Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-22
Control Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-23
LCD Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24
Function Buttons . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-25
PageWriter Trim II and III Features . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-26
PageWriter Trim II and III Status Bar. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27
PageWriter Trim II and III Command Toolbar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-28
The Patient Session
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-1
Patient Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Instructing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Preparing the Skin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Attaching the Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Attaching the Lead Wires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Checking Signal Quality. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Using the PageWriter Trim I Signal Quality Indicators . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Heart Beat Detector . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Leads Off Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Signal Quality Indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Troubleshooting Signal Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Using the PageWriter Trim II and III Signal Quality Indicators . . . . . . . . . . . . . . . . . . . . .2-9
Using the Leads off indicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Color-coded waveforms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Troubleshooting Signal Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Using Filters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11 Artifact Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12 Baseline Wander Filter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12 Frequency Response Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13 About High and Low Pass Frequency Filter Settings . . . . . . . . . . . . . . . . . . . . . . . .2-13 Changing Filter Settings on the PageWriter Trim I . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13 Changing Filter Settings on the PageWriter Trim II and III . . . . . . . . . . . . . . . . . . . . . . .2-15 Artifact and Baseline Wander Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-16 Display Filter Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17 Entering Patient ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-17 Entering Patient ID Information on the PageWriter Trim I . . . . . . . . . . . . . . . . . . . . . .2-18
Entering Patient ID Information on the
PageWriter Trim II and III. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19 Entering Patient ID Information with the Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-19 Opening a Pending Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20 Entering Patient ID Information with the Barcode Reader . . . . . . . . . . . . . . . . . . . . . . .2-21 Entering Patient ID Information with the
Magnetic Card Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-21 Entering Patient ID Information with the
SmartCard Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-22 Editing Patient ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23 Emergency (STAT) ECGs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-23
Contents-2 PageWriter Trim Cardiograph Instructions for Use
Taking an Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24 Taking an Auto ECG with the PageWriter Trim I. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-24 Taking an Auto ECG with the PageWriter Trim II and III. . . . . . . . . . . . . . . . . . . . . . . 2-25 The Preview Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25 Changing Auto Report Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-25 Using the Metronome with Auto ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-26
Rhythm ECG Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27 Taking a Rhythm Report on the PageWriter Trim I . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-27 Taking a Rhythm Report on the PageWriter Trim II and III . . . . . . . . . . . . . . . . . . . . . 2-28 Disclose ECG Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-29 Pacing Detection Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-30 Getting Help on the Cardiograph. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32
Reading the Printed ECG Report
Interpretive, Reason, and Severity Statements. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Severity Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Basic Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-4
Patient ID Clinical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Patient ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-6
Additional Patient ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Institution Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-7
Configurable Clinical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-8
ECG Order Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9
Physician Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Report Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Calibration Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-11
Time Separator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Pacing Detection Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-13
Algorithm Version Number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Speed and Sensitivity Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-16
Device Identification Number. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17
12-Lead ECG Report Examples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-18
Extended Measurements Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
PageWriter Trim III only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Rhythm Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-25
Disclose Report. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
PageWriter Trim II and III only . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-28
PageWriter Trim II and III
Orders and Archive
About Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
About the Archive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1
PageWriter Trim Cardiograph Instructions for Use |
Contents-3 |
Using the Order Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-2 Entering New Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4 Deleting an Order. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4 Editing an Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5 Using the Archive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
Saving Auto Reports to the Archive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6 Opening the Archive Screen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7 Transferring Auto Reports to a TraceMaster ECG Management System. . . . . . . . . . . . . . . .4-9 Viewing and Printing Auto Reports in the Archive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11 Faxing Auto Reports in the Archive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12 Editing Patient ID Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13 Exporting 12-lead Reports in XML Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14 Printing a List of Auto Reports in the Archive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-14 Searching a TraceMaster Remote Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15
Searching a Remote Site with the Wildcard Character . . . . . . . . . . . . . . . . . . . . . . . . .4-15 Deleting Auto Reports from the Archive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
PageWriter Trim II and III Configuration
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1 Configuring Multiple Cardiographs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1 Password Access . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1 Configuration with a Philips TraceMaster ECG Management System . . . . . . . . . . . . . . .5-1 Restoring Cardiograph Configured Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-1
Opening the Configuration Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Analysis Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-2
Patient ID Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4
Patient ID Configuration Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4
Configuring Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5
User Defined Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7
Configuring Clinical Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7
User Defined Clinical Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
Configuring Order Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10
User Defined Order Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-12
Configuring Auto Report Profiles. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-12
Editing the Profile Report Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-15
Editing Profile Interpretation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16
Editing Profile Scale Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16
Editing Report Type Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-16
Saving the Report Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17
Setting the Default Auto Report and Copy Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-17
Setting Other Print Options. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-18
System Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-18
Battery Power Saving Modes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-19
Simulated Waveform Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-20
Filter Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-21
Contents-4 PageWriter Trim Cardiograph Instructions for Use
About High and Low Pass Frequency Filter Settings . . . . . . . . . . . . . . . . . . . . . . . 5-21 Setting Default Rhythm Filter Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22 Remote Sites Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-22
Remote Site Fax and Modem Connection
(USA and Canada only) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-24 Remote Sites Network Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-25 Network Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27 Networking Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27 DHCP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-27 Fixed IP Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28 Auto Negotiation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-28
Password Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Lost Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-30
Locale Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Cardiograph Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-31
Metronome Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-34
Magnetic Card Reader Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-35
Saving Configured Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Loading the Configuration Settings File . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-36
Restoring Factory Default Configuration Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-37
Troubleshooting
Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Troubleshooting Topics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
Archive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Barcode Reader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Battery and AC Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
LAN and Modem Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Leads Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Magnetic Card Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-10
Signal Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-14
System Freeze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-16
Resetting the Cardiograph . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-17
Cardiograph Care and Maintenance
Cardiograph Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 Approved Cleaning Solutions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1 PIM, Patient Data Cable and Lead Wire Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Reusable Electrode Cleaning. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2 Changing the Date and Time on the PageWriter Trim I . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3 Changing the Date and Time on the PageWriter Trim II and III . . . . . . . . . . . . . . . . . . . . . . 7-3 Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4 Tips for changing printer paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-4
PageWriter Trim Cardiograph Instructions for Use |
Contents-5 |
Battery Maintenance and Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-5 Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6 Battery Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6 Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-7 Replacing the AC Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-8 Replacing the Lead Wires on the PIM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-9 Maintenance Tests. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-10
PIM Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12 Barcode Reader Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-12 Magnetic Card Reader Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13 Printer Test. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-13 Network Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-16
Important Patient and Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-16
Supplies and Ordering Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-20
Ordering Supplies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-20
PageWriter Trim Cardiograph Supply Part Numbers. . . . . . . . . . . . . . . . . . . . . . . . . . .7-20
Patient Interface Module (PIM) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-20
Replacement Fuse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-20
Complete Lead Sets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-20
Replacement Lead Sets and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-20
Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-21
Printer Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-21
Optional Cardiograph Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-22
Optional Cardiograph Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-22
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-22
Contacting a Philips Response Center . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-23
North America Response Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-23
South America Response Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-23
Europe Response Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-23
Asia Response Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-24
Specifications
Technical Specifications. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
ECG Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Screen Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Patient Interface Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Cardiograph Cart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1
Signal Processing/Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Sampling Rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Auto Frequency Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Rhythm Frequency Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Filters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Printer Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Report Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Contents-6 PageWriter Trim Cardiograph Instructions for Use
Battery Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Capacity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Recharge. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Network Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 FAX Capability (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Modem (optional for USA and Canada) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Barcode Reader (optional) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Magnetic Card Reader (optional). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 ECG Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 ECG File Formats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3 Power and Environment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Line Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Environmental Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Environmental Storage Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Cardiograph Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Cardiograph Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Cardiograph Shipping Container Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Cardiograph Shipping Container Weight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Cardiograph Cart Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Cardiograph Cart Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4 Cardiograph Cart Shipping Container Dimensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5 Cardiograph Cart Container Weight. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5 Safety and Performance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5 Electromagnetic Compatibility (EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5 Reducing Electromagnetic Interference . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Assembling the Patient Cable Arm
Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1
Assembly Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
PageWriter Trim Cardiograph Instructions for Use |
Contents-7 |
Safety Symbols Marked on the Cardiograph
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Description |
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Attention |
See PageWriter Trim Instructions for Use for |
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information. |
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Type CF |
ECG physio isolation is type CF, defibrillator proof. |
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Electrical leakage current is suitable for all patient |
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applications including direct cardiac application. |
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Alternating current |
Indicates that the cardiograph is receiving alternating |
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currents. |
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On/Standby |
Pressing the button with this symbol on it turns on the |
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cardiograph or puts the cardiograph into Standby |
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(power saving mode). |
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Do not touch exposed pins. Touching exposed pins can |
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Electrostatic Discharge |
cause electrostatic discharge that can damage the |
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cardiograph. |
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Equipotential grounding post |
Equipotential grounding post used for establishing |
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common ground between instruments. |
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Fuse |
Cardiograph contains a 1.5 amp (250V) time-delay |
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fuse. |
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Input |
The connector near this symbol receives an incoming |
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signal. |
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Serial Number |
The number next to this symbol is the serial number of |
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the cardiograph. |
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Product model number |
The number next to this symbol is the product model |
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number of the cardiograph |
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Entry of liquids |
The cardiograph is not protected against splashing |
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water. |
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Entry of liquids |
The PIM (Patient Interface Module) is protected |
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against splashing water. Water splashed against the |
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PIM from any direction shall have no harmful effect. |
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PageWriter Trim Cardiograph Instructions for Use |
i |
|
AC power indicator light |
When lit, indicates that AC power is on. The battery is |
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charging when inserted into the cardiograph. |
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Safety Symbols Marked on the Cardiograph Packaging
Symbol Description
Keep dry.
Ambient temperature range of 0 oC (32o.F) to 50 oC (122o F) (non-condensing) for transport and storage.
Atmospheric pressure range of 466 hPa to 1014 hPa for transport and storage.
Relative humidity range of 25% to 80% (non-condensing) for transport and storage.
Move and store packaging this end up.
Fragile.
Sealed lead acid battery. Do not dispose of in trash. Follow local regulations for disposing of as small chemical waste.
Recycle the packaging materials after use.
ii |
PageWriter Trim Cardiograph Instructions for Use |
Conventions Used in the Instructions for Use
WARNING Warning statements describe conditions or actions that may result in personal injury or loss of life.
CAUTION Caution statements describe conditions or actions that may result in damage to equipment or software.
NOTE Notes contain additional important information about a topic.
TIP A Tip contains suggested information on using a particular feature.
Menu item |
Menu items and button names appear in a bold no-serif font. |
Button name |
Example: Highlight the Config button. |
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The PageWriter Trim cardiograph isolates all connections to the patient from electrical ground and all other conductive circuits in the cardiograph. This reduces the possibility of hazardous currents passing from the cardiograph through the patient’s heart to ground, and from other equipment connected to the patient passing through the leads into the cardiograph to ground.
WARNING Failure to follow these warnings could affect both patient and operator safety.
When operating the cardiograph on AC power, ensure that the cardiograph and all other electrical equipment connected to or near the patient are effectively grounded.
Use only grounded power cords (three-wire power cords with grounded plugs) and grounded electrical outlets. Never adapt a grounded plug to fit an ungrounded outlet by removing the ground prong. Use the equipotential post when redundant earth ground is necessary according to IEC 60601-1-1.
If a safe ground connection is not ensured, operate the cardiograph on battery power only.
The use of equipment that applies high frequency voltages to the patient (including electrosurgical equipment and some respiration transducers) is not supported and may produce undesired results. Disconnect the patient data cable from the cardiograph, or detach the leads from the patient prior to performing any procedure that uses high frequency surgical equipment.
Do not perform ST analysis on the R/T ECG screen display or on Rhythm reports when the 0.5 Hz Baseline Wander filter is applied.
PageWriter Trim Cardiograph Instructions for Use |
iii |
Important Patient and Safety Information
If abnormal ECG data appears on the printed report, and the abnormal data does not have a physiological origin, perform the printer diagnostic test to assess printer performance (see page 7-13).
When printing a Rhythm report, there may be a slight delay before the Rhythm report begins to print on the cardiograph. Rhythm printing is not completed in real-time.
Pace pulse tick marks will not print on an Auto report that uses simultaneous acquisition.
WARNING Do not touch accessible connector pins and the patient simultaneously.
Electrical shock hazard. Keep cardiograph, Patient Interface Module (PIM) and all cardiograph accessories away from liquids. Do not immerse cardiograph, PIM, or other accessories in any liquids.
Periodically inspect the patient data cable, lead wires, and AC power cord for any worn or cracked insulation to ensure that no inner conductive material is exposed. Discard worn accessories and replace them only with Philips Medical Systems accessories (see page 7- 20).
Keep the patient data cable away from power cords and any other electrical equipment. Failure to do so can result in AC power line frequency interference on the ECG trace.
The Philips Medical Systems patient data cable (supplied with cardiograph) is an integral part of the cardiograph safety features. Use of any other patient data cable may compromise defibrillation protection, degrade cardiograph performance, and may result in distorted ECG data.
Only qualified personnel may service the cardiograph or may open the cardiograph housing to access internal cardiograph components. Do not open any covers on the cardiograph. There are no internal cardiograph components that are serviced by the operator.
Do not use this cardiograph near flammable anesthetics. It is not intended for use in explosive environments or in operating rooms.
Do not touch the patient, the patient data cable, any unused patient leads, or the cardiograph during defibrillation. Death or injury may occur from the electrical shock delivered by the defibrillator.
The PageWriter Trim I is not recommended for diagnostic cardiograph use during defibrillation. It does not provide less than 10 seconds of real-time data.
Always use electrode gel with reusable electrodes during defibrillation as ECG recovery will be greater than 10 seconds. Philips Medical Systems recommends the use of disposable electrodes at all times.
Ensure that the electrodes or lead wires do not come in contact with any other conductive materials (including earth-grounded materials) especially when connecting or disconnecting electrodes to or from a patient.
ivPageWriter Trim Cardiograph Instructions for Use
Important Patient and Safety Information
Connecting multiple medical electrical equipment to the same patient may pose a safety hazard due to the summation of leakage currents. Any combination of instruments should be evaluated by local safety personnel before being put into service.
Portable medical equipment such as X-rays and MRI may produce electromagnetic interference that produces noise in the ECG signal. Move the cardiograph away from these potential sources of electromagnetic interference.
Do not pull on the paper while an ECG report is being printed. This can cause distortion of the waveform and can lead to potential misdiagnosis.
Only use the Philips Medical Systems AC power cord supplied with the cardiograph. Periodically inspect the AC power cord and AC power connector (rear of cardiograph, see figure 1-2 on page 1-8) to ensure that both are in a safe and operable condition. If the AC power cord or AC power connector is not in a safe or operable condition, operate the cardiograph on battery power and contact Philips Medical Systems for service.
The cardiograph has been safety tested with the recommended accessories, peripherals, and leads, and no hazard was found when the cardiograph is operated with cardiac pacemakers or other stimulators.
Do not connect any equipment or accessories to the cardiograph that are not manufactured or approved by Philips Medical Systems or that are not IEC 60601-1 approved. The operation or use of non-approved equipment or accessories with the cardiograph is not tested or supported, and cardiograph operation and safety are not guaranteed.
The list of cables and other accessories with which Philips claims compliance with the emissions and immunity requirements of IEC standard 60601-1-2 are listed in “Supplies and Ordering Information” on page 7-20.
WARNING When using additional peripheral equipment powered from an electrical source other than the cardiograph, the combination is considered to be a medical system. It is the responsibility of the operator to comply with IEC 60601-1-1 and test the medical system according to the requirements. For additional information contact Philips Medical Systems.
WARNING Do not use non-medical peripherals within 1.83 meters or 6 feet of a patient unless the non-medical peripherals receive power from the cardiograph or from an isolation transformer that meets medical safety standards.
Only install Philips Medical Systems software on the cardiograph. The installation or use of software not approved by Philips Medical Systems is strictly prohibited and cardiograph safety and performance are not guaranteed.
Only use Philips Medical Systems replacement parts and supplies with the cardiograph. The use of non-approved replacement parts and supplies with the cardiograph is strictly prohibited. Cardiograph safety and performance are not guaranteed when non-approved replacement parts and supplies are used with the cardiograph.
PageWriter Trim Cardiograph Instructions for Use |
v |
The PageWriter Trim Cardiograph |
Intended Use |
Manual measurements of ECG intervals and magnitudes should be performed on printed ECG reports only. Do not make manual measurements of ECG intervals and magnitudes on the R/T ECG display since these ECG representations are scaled.
Only use patient electrodes that are approved by Philips Medical Systems. The use of nonapproved patient electrodes may degrade cardiograph performance.
The Philips Medical Systems warranty is applicable only if you use Philips Medical Systems approved accessories and replacement parts. See “Supplies and Ordering Information” on page 7-20 for more information.
Before using the Patient Cable Arm with the cardiograph cart, properly install the counter balance on the cardiograph base.
Only use the shielded LAN cable provided with the PageWriter Trim cardiograph, Philips Part Number 989803138021. Do not use any other LAN cables with the PageWriter Trim cardiograph. Use of unapproved LAN cables may result in radiated emissions that exceed the limit specified by CISPR11 Class B.
The combined maximum weight that can be placed on the cardiograph cart shelf and the top surface of the cart cannot exceed 20 kg (44 lbs). Do not place more than the specified weight on the cardiograph top surface and shelf.
Do not connect any device to the RS-232 port on the rear of the cardiograph when the patient data cable is connected to a patient.
There are no cardiograph parts that can be sterilized.
The cardiograph is not intended for direct, or invasive cardiac monitoring purposes.
Excessive, repetitive use of the cardiograph keyboard and the cardiograph Trim Knob may result in a risk of developing carpal tunnel syndrome.
Ensure that the patient data cable is tucked away from the cardiograph cart wheels when transporting the cardiograph. Ensure that the patient data cable does not present a hazard when pushing the cardiograph cart.
The PageWriter Trim Cardiograph
Intended Use
The intended use of the cardiograph is to acquire multi-channel ECG signals from adult and pediatric patients from body surface ECG electrodes and to record, display, analyze, and store these ECG signals for review by the user. The cardiograph is to be used in healthcare facilities by trained healthcare professionals. Analysis of the ECG signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations, and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings.
vi |
PageWriter Trim Cardiograph Instructions for Use |
Indications for Use |
The Philips 12-Lead Algorithm |
A qualified physician is asked to overread and validate (or change) the computer-generated ECG interpretation.
The cardiograph is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment, or to rule out causes for symptoms.
The Philips 12-Lead Algorithm
The PageWriter Trim Cardiograph software uses the Philips 12-Lead Algorithm. The algorithm in the software analyzes the morphology and rhythm on each of the 12 leads and summarizes the results. The set of summarized measurements is then analyzed by the clinically-proven ECG Analysis Program.
12-lead Reports may include or exclude ECG measurements, reasons, or analysis statements.
The intended use of the Philips 12-Lead Algorithm is to analyze multi-channel ECG signals from adult and pediatric patients with algorithms that provide measurements, data presentations, graphical presentations, and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical examination, the ECG tracings, and other clinical findings. A qualified physician is asked to overread and validate (or change) the computer-generated ECG interpretation.
Indications for Use
The Philips 12-Lead Algorithm is to be used where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment, or to rule out causes for symptoms.
PageWriter Trim Cardiograph Instructions for Use |
vii |
1
Welcome to the PageWriter Trim Cardiograph! With its intuitive operation, clearly labeled PIM and lead wires, and convenient cart, it is the ideal cardiograph for processing large volumes of ECGs quickly and easily.
The PageWriter Trim supports multiple ECG acquisition modes, display settings, and report formats. Signal quality indicators provide instant feedback to the user to help ensure a quality ECG each and every time.
This PageWriter Trim Cardiograph Instructions for Use provides comprehensive information on the cardiograph and all of its components. It is intended to be used with the other materials included in the PageWriter Trim Cardiograph Learning Kit.
N OTE Read and complete the materials included in the PageWriter Trim Cardiograph Learning Kit before using the cardiograph. Read all Patient Safety information and pay close attention to all warnings and cautions. For more information, see “Important Patient and Safety Information” on page -iii.
1-1
Getting Started |
PageWriter Trim Cardiograph Learning Kit |
PageWriter Trim Cardiograph Learning Kit
Philips Medical Systems provides detailed instructional and reference materials in the PageWriter Trim Learning Kit
The PageWriter Trim Learning Kit contains the Getting Started Guide, a Quick Help Card, and the User Documentation and Interactive Training CDs.
Figure 1-1 The PageWriter Trim Cardiograph Learning Kit
C
A
B
D
Getting Started Guide (A)
This guide includes important information that must be read before operating the cardiograph. It includes an overview of cardiograph features and functions, assembly and setup instructions, how to configure the cardiograph, and how to order supplies.
Quick Help Card (B) This card provides quick reference information about basic cardiograph features, lead placement, and signal quality indicators. It is also provided as a PDF file on the PageWriter Trim User Documentation CD.
PageWriter Trim Cardiograph Interactive Training Program CD (C)
The interactive training CD contains a computer-based training program about the proper recording of ECGs and how to operate the cardiograph.
Use this program to train the entire ECG staff in the proper operation of the cardiograph.
To run the interactive training program:
XInsert the CD into a PC CD-ROM drive. The CD only works on PCs with a Windows operating system.
The interactive training program starts automatically.
1-2 |
PageWriter Trim Cardiograph Instructions for Use |
Getting Started |
Attaching the Cardiograph to the Cart |
PageWriter Trim User Documentation CD (D)
The User Documentation CD contains the following files:
–Philips 12-Lead Algorithm Physician’s Guide
This PDF file describes the Philips 12-Lead Algorithm, and lists all of the interpretive statements included in the 0A criteria.
–PageWriter Trim Instructions for Use
This PDF file includes complete information on all aspects of using and maintaining the cardiograph.
–PageWriter Trim Quick Help Card
A PDF version of the Quick Help Card provided in the Learning Kit.
–PageWriter Trim Cardiograph XML Schema (English only)
The schema for the XML ECG data exported from the PageWriter Trim cardiograph.
To view user documentation:
XInsert the CD into a PC CD-ROM drive. The CD only works on PCs with a Windows operating system.
The user documentation CD main menu opens automatically. Click on a blue button or the file name to open the file.
NOTE Adobe Acrobat Reader does not need to be installed on the PC to view the PDF files on the CD. If PDF files from the CD are saved to a PC hard drive, Acrobat Reader will need to be installed on the PC in order to view the files. For a free install go to: www.adobe.com.
1If the menu does not automatically appear, open the CD in Windows Explorer.
2Double-click the file menu.pdf on the CD. The PDF menu appears. Any of the files on the CD may be printed or saved to a PC hard drive.
Attaching the Cardiograph to the Cart
The PageWriter Trim cardiograph is available with an optional cart that includes a storage shelf and a holder for the PIM (Patient Interface Module).
CAUTION Follow the procedure below to ensure that the cardiograph is securely fastened to the cart before use.
PageWriter Trim Cardiograph Instructions for Use |
1-3 |
Getting Started |
Attaching the Cardiograph to the Cart |
To attach the cardiograph to the cart:
1Align the front feet of the cardiograph with the front locking holes on the cart. Align the rear feet of the cardiograph with the rear screw holes on the cart. Lower the cardiograph onto the cart.
2Slide the cardiograph back to lock the front and rear feet into place. Insert the screws through the bottom of the cart and through the screw holes. Tighten the screws with a Phillips head screwdriver.
1-4 |
PageWriter Trim Cardiograph Instructions for Use |
Getting Started |
PageWriter Trim I Cardiograph Parts |
PageWriter Trim I Cardiograph Parts
The following sections show front, side, and rear views of the PageWriter Trim I cardiograph.
Figure 1-1 PageWriter Trim I Cardiograph and Cart (Front View)
A
G
H
B
C
D
E
F
A |
Patient Interface Module (PIM) |
E |
PIM Leads |
B |
Printer paper/report storage slot |
F |
Wheel Brake |
C |
Storage Shelf |
G |
Control Panel |
D |
AC Power Cord |
H |
Printer Paper Drawer |
CAUTION Always lock the wheel brake (F) when the cart is not in use. Press down on the wheel brake to set or to release the wheel brake.
PageWriter Trim Cardiograph Instructions for Use |
1-5 |
Getting Started |
PageWriter Trim I Cardiograph Parts |
Figure 1-2 PageWriter Trim I Cardiograph (Rear View)
I J K
O |
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L |
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N |
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M |
I |
Reset Button |
M |
Battery Door |
J |
AC Power Cord Connector |
N |
PIM Connector |
K |
Equipotential Post |
O Serial Connector (not supported) |
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L |
Fuse Door |
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WARNING Do not connect a LAN cable connector to the PIM connector. Do not plug a telephone connector into the PIM connector.
1-6 |
PageWriter Trim Cardiograph Instructions for Use |
Getting Started |
PageWriter Trim II and III Cardiograph Parts |
PageWriter Trim II and III Cardiograph Parts
The following sections show front, side, and rear views of the PageWriter Trim II and III cardiographs.
Figure 1-1 PageWriter Trim II and III Cardiograph and Cart
(Front View)
G
A
H
I
J
B
C
D
E
F
A |
Patient Interface Module (PIM) |
F |
Wheel Brake |
B |
Printer paper/report storage slot |
G |
Control Panel |
C |
Storage Shelf |
H |
Keyboard |
D |
AC Power Cord |
I |
Trim Knob |
E |
PIM Leads |
J |
Printer Paper Drawer |
CAUTION Always lock the wheel brake (F) when the cart is not in use. Press down on the wheel brake to set or to release the wheel brake.
PageWriter Trim Cardiograph Instructions for Use |
1-7 |
Getting Started |
PageWriter Trim II and III Cardiograph Parts |
Figure 1-2 PageWriter Trim II and III Cardiograph (Rear View)
K L M N O
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U |
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P |
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T |
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Q |
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S |
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R |
K |
Reset Button |
Q Battery Door |
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L |
PC Card Eject Button |
R |
PIM Connector |
M |
PC Card Slot |
S |
SmartCard Reader (USB) Connector |
N |
AC Power Connector |
T |
Barcode Reader or Magnetic Card |
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Reader Connector |
O Equipotential Post |
U Serial Connector (not supported) |
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P |
Fuse Door |
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WARNING Do not connect the LAN cable connector into the PIM connector. Do not plug a telephone connector into the PIM connector.
1-8 |
PageWriter Trim Cardiograph Instructions for Use |
Getting Started |
Installing the Battery |
Installing the Battery
The cardiograph is shipped with one removable battery. Install the battery before plugging the cardiograph into AC power.
Figure 1-3 Installing the Battery
To install the battery:
1Open the battery door on the rear of the cardiograph. Push the recessed tab in and pull it down to open the battery door.
2Insert the battery into the compartment with the connector facing down and the pull tab facing out.
3Push in the pull tab to lock it.
4Reattach and close the battery door.
5Attach the AC power cord to the rear of the cardiograph.
PageWriter Trim Cardiograph Instructions for Use |
1-9 |
Getting Started |
Installing the Battery |
6Plug the AC power cord into a grounded electrical outlet. Check that the green AC power indicator light is on (front of cardiograph).
7Charge the battery for at least 24 hours before mobile use.
On the PageWriter Trim II and III, a lightening bolt icon ( ) appears on the Battery Level Indicator on the Status Bar when the cardiograph is plugged into AC power and the battery is charging. Check the Battery Power Indicator on the Status Bar to ensure that the battery is fully charged, see “PageWriter Trim II and III Status Bar” on page 1-27. The cardiograph can operate on AC power while the battery is charging, but the battery will charge at a slower rate.
On the PageWriter Trim I, the following battery icon ( ) flashes on the LCD display when the cardiograph is plugged into AC power and the battery is charging, see “LCD Display” on page 1-24. The battery level indicator displays the following battery icon
( ) when the battery is fully charged. The cardiograph can operate on AC power while the battery is charging, but the battery will charge at a slower rate.
1-10 |
PageWriter Trim Cardiograph Instructions for Use |
Getting Started |
Loading the Printer Paper |
Loading the Printer Paper
Replace the printer paper when a red stripe appears on the printed ECG report. Only use Philips Medical Systems replacement printer paper. For part number and ordering information, see page 7-20.
Always load less than 100 sheets of printer paper into the paper tray
Ensure that the entire first page of the new paper roll is fully draped over the roller before closing the printer door
PageWriter Trim II and III:
Ensure that the paper size configured for the cardiograph is the same size paper being loaded into the paper drawer (see page 5-18)
Figure 1-4 Loading Printer Paper
A
A Paper sensor hole
To change the printer paper:
1Open the paper drawer on the front of the cardiograph.
2Insert a new pack of printer paper with the printed side facing up. Ensure that no more than 100 sheets are being inserted into the paper tray.
3Ensure that the paper sensor hole (A) is positioned as shown in Figure 1-4.
4Drape the entire first sheet over the roller. Ensure that the perforated edge of the paper aligns with the edge of the paper drawer.
5Close the paper drawer.
6Tear off the first sheet as shown in Figure 1-4.
PageWriter Trim Cardiograph Instructions for Use |
1-11 |
Getting Started |
Patient Interface Module (PIM) |
Patient Interface Module (PIM)
The Patient Interface Module (PIM) is a hand-held device that connects to the cardiograph. The lead wires on the PIM attach to the electrodes placed on the patient. The exterior of the PIM is labeled and color-coded for quick and easy lead identification.
Figure 1-5 Patient Interface Module
A
B
D C
A |
Lead Wire Labeling |
C Limb Lead Wires |
B |
Patient Data Cable |
D Precordial (Chest) Lead Wires |
1-12 |
PageWriter Trim Cardiograph Instructions for Use |
Getting Started |
Patient Interface Module (PIM) |
The exterior of the PIM is color-coded for quick and easy lead identification. The lead wires that are included with the cardiograph must be inserted into the correct lead wire connector on the PIM.
Figure 1-6 PIM connector and lead wire labeling
C
B
A
A |
Lead Wire Connector |
C Lead Wire Labeling |
B |
Lead Wire |
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To insert the lead wires into the PIM:
1Locate the lead wires in the cardiograph packaging.
2Match the lead wire to the correct lead wire connector on the PIM.
3Insert each lead wire into the correct lead wire connector on the PIM.
4Push down on the lead wire to ensure that there is no gap between the lead wire and the connector.
PageWriter Trim Cardiograph Instructions for Use |
1-13 |
Getting Started |
Patient Interface Module (PIM) |
Connect the patient data cable on the PIM to the PIM connector port ( ) on the rear panel of the cardiograph.
To connect the PIM to the cardiograph:
X Connect the patient data cable to the PIM connector port on the rear of the cardiograph.
WARNING To ensure safety and prevent damage to the system, only connect the patient data cable to the PIM connector port on the rear of the cardiograph.
1-14 |
PageWriter Trim Cardiograph Instructions for Use |