Spacelabs Healthcare CardioPulse Prime Operating Manual
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Spacelabs Healthcare CardioPulse Prime Operating Manual

Spacelabs Healthcare CardioPulse Prime Operating Manual

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Summary of Contents for Spacelabs Healthcare CardioPulse Prime

  • Page 1 CardioPulse Prime Operating manual only...
  • Page 2 ©2021 Spacelabs Healthcare All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of Spacelabs Healthcare. Products of Spacelabs Healthcare are covered by U.S. and foreign patents and/or pending patents. Spacelabs Healthcare considers itself responsible for the effects on safety, reliability and performance of the equipment only if: •...

  • Page 3: Table Of Contents

    1.14.1 Additional statements............... 11 1.15 Symbols and Pictograms........... 12 1.15.1 Symbols used in this document ............12 1.15.2 Symbols used on the device ............13 Introduction ..........14 Main Components of the CardioPulse Prime....14 2.1.1 Standard................... 15 2.1.2 Options..................... 15 Connections................ 15 Display.................
  • Page 4 CardioPulse Prime Changing the Printing Paper ..........25 Patient / recording data............26 3.6.1 Patient data query (PDQ) ..............29 3.6.2 PDQ in the worklist/memory ............. 29 3.6.3 Barcode reader ................. 30 Electrode placement ......31 Basics .................. 31 Electrode Identification and Color Code ......32 Standard 10-lead resting ECG ...........
  • Page 5 CardioPulse Prime User guide General and System Settings ....61 Navigation ................61 8.1.1 Overview Menu > Settings ............. 62 8.1.2 Saving and restoring settings............63 ECG Menu ................64 8.2.1 Lead & Cable ................... 64 8.2.2 Filter & Formulas................64 8.2.3...
  • Page 6 CardioPulse Prime 10.8 Inspection Report ............... 91 10.8.1 Lifed-item replacement every 3 - 5 years ......... 92 Trouble Shooting ........93 11.1 Possible problems.............. 93 11.2 Preventing electromagnetic interferences ....... 95 11.2.1 Measures to prevent electromagnetic interference ......96 11.3 Accessories and disposables ...........

  • Page 7: Safety Notes

    1 Safety notes Intended Use  The CardioPulse Prime is a 12-lead electrocardiograph intended to be used by or under the direct supervision of a licensed healthcare practitioner in healthcare facilities to acquire ECG signals from body surface electrodes, record, analyze, display and print ECGs for diagnosis in adult and pediatric patients.

  • Page 8: Contraindications

    – direct cardiac application – use in an MRI suite – outdoor use  The CardioPulse Prime is not intended to be used as a vital signs physiological monitor. Intended users  The CardioPulse Prime is intended to be used by trained operators under supervision of a licensed health care practitioner.

  • Page 9: Patient Target Group

    User guide Patient target group Patient target group The CardioPulse Prime is intended to be used for adult and pediatric patients. Pediatric patients are defined as follows: • Neonates: from birth through the first 28 days of life • Infants: 29 days of age to less than two years of age •...

  • Page 10: Safety-Conscious Operation

    AC power and wipe it. The device must be checked before reusing.  Only connect the original Spacelabs Healthcare patient cable to the patient socket.  If the patient cable should become defective after defibrillation, an electrode becomes displaced, or an electrode resistance is too high, a lead-off indication is displayed in the upper right part of the screen.

  • Page 11: Operation With Other Devices

    1.12 Network safety  When the CardioPulse Prime is part of a network (LAN, WLAN, HIS, etc.), the operator of the network/data coupling must take appropriate security measures to protect the transmission of data. Networks that are not protected and maintained can lead to failure of the data transmission or to incorrect transmission of data, which in turn can result in danger to the patient.

  • Page 12: Maintenance

    Spacelabs Healthcare assumes no liability for the loss of data saved on the computer or on the device. The owner is solely responsible for the data backup.

  • Page 13: Additional Statements

     Any changes or modifications to this equipment not expressly approved by Spacelabs Healthcare may cause harmful radio frequency interference and void your authority to operate this equipment.  Within the 5150 to 5250 MHz band (5 GHz radio channels 34 to 48) the module type cB-0941 is restricted to indoor operations to reduce any potential for harmful interference to co-channel MSS operation.

  • Page 14: Symbols And Pictograms

    Safety notes 1.15 Symbols and Pictograms CardioPulse Prime 1.15 Symbols and Pictograms 1.15.1 Symbols used in this document The safety level is classified according to ISO 3864-2. The following overview shows the safety symbols and pictograms used in this user guide.

  • Page 15: Symbols Used On The Device

    (Wi-Fi). The CardioPulse Prime radiates high-frequency electromagnetic energy and can disturb other devices if the CardioPulse Prime is not installed and operated in accor- dance with the user guide. However, there is no guarantee that no interference can occur in certain installations. If the CardioPulse Prime causes interferences, these can be determined by switching the device off/on or by transmitting/not transmitting ECG data.

  • Page 16: Introduction

    Main Components of the CardioPulse Prime CardioPulse Prime 2 Introduction The Spacelabs Healthcare CardioPulse Prime is a 12-channel ECG unit designed to record, display and measure resting ECGs. The CardioPulse Prime has the following features: Main Components of the CardioPulse Prime...

  • Page 17: Standard

    Introduction CardioPulse Prime User guide Connections 2.1.1 Standard • Pacemaker detection • Manual rhythm printout in real time (leads, speed and amplitude can be changed) • Auto mode recording (10 seconds) with user-defined layout • Resting rhythm • Measurements • Full disclosure of all 12 channels •...

  • Page 18: Display

    Introduction Display CardioPulse Prime Display The display will vary according to the task being carried out. In all screens, however, the top and bottom areas always display the same category of information. Example for a typical patient data view: Access to the main menu:...

  • Page 19: Display Details

    Introduction CardioPulse Prime User guide Display details Display details Displays and function keys during a resting ECG recording:  Open/close the main Patient ID / Visit ID John Doe I 53 years I Male menu Visit ID Patient ID Patient ID...
  • Page 20 Introduction Display details CardioPulse Prime Patient ID I Visit ID John Doe I 53 years I Male Normal Rhythm Averages Recorded ECG Results Measurements Discard Accept Patient Print by pressing Normal Normal Normal Interpretation Sinus rhythm Normal electrical axes Normal ECG...

  • Page 21: Keyboard

    Introduction CardioPulse Prime User guide Keyboard Keyboard (1) Power On/OFF Press the On/Off button to switch the device on or off. (2) Power Indicator The power supply LEDs indicate the power source (see Page 23). (3) Direct function key Auto Start...

  • Page 22: Connections

    Connections CardioPulse Prime Connections  All externally connected hardware must be approved by Spacelabs Healthcare. Connection of any hardware not approved by Spacelabs Healthcare is at the owner‘s risk. Moreover, the unit's warranty may become invalid. 2.6.1 Back panel (1) Power supply unit connection 100 -240 VAC, 50/60 Hz, 1.3 A.

  • Page 23: Operation

    • Do not allow the unit to come into contact with acidic vapors or liquids. • The CardioPulse Prime should not be placed in the vicinity of X-ray or diathermy units, large transformers or electric motors.

  • Page 24: Switching On / Off

    Operation Switching on / off CardioPulse Prime Switching on / off  The unit is switched on and off with the On / Off key. • The switching off must be confirmed by pressing the key. • If access control is activated, the ON-OFF key must be pressed twice.

  • Page 25: Power Supply

    Operation CardioPulse Prime User guide Power supply Power supply 3.3.1 AC power and battery indicators The unit can either be operated by the AC power supply or by the built-in rechargeable battery. The LED indicates that the device is connected to the AC power.

  • Page 26: System And Ecg Settings

    Operation System and ECG settings CardioPulse Prime System and ECG settings • The system settings (time, date, device ID etc.) and other general settings are de- scribed on Page • Resting ECG settings (auto format, user defined leads, print options, interpretation, rhythm lead definition, etc.) are described on...

  • Page 27: Changing The Printing Paper

    • Certain glues can react with the paper. Therefore, do not use glue to attach the printout onto a mounting sheet. Spacelabs Healthcare can only guarantee perfect printouts when original chart paper or chart paper of the same quality is used.

  • Page 28: Patient / Recording Data

    Operation Patient / recording data CardioPulse Prime Patient / recording data In the patient data screen, new patients can be entered and previously stored patient data can be edited If a recording is performed without having entered a patient or visit ID, a UUID is generated instead of a patient ID, "Emergency ECG"...
  • Page 29 Operation CardioPulse Prime User guide Patient / recording data Patient data - left entry fields Patient ID Enter the patient's identification number. Last name Enter patient's name (maximum 50 characters). First name Enter patient's first name (maximum 50 characters). Enter the patient‘s date of birth in the format dd.mm.yyyy, yyyy-mm-dd or mm/dd/ yyyy.
  • Page 30 Operation Patient / recording data CardioPulse Prime • Menu > Settings > General > Access control > Access control mode > Local > “User name” • Menu > Settings > General > Access control > Access control mode > Schiller Server >...

  • Page 31: Patient Data Query (Pdq)

    Operation CardioPulse Prime User guide Patient / recording data 3.6.1 Patient data query (PDQ) When the unit is connected to Server or another hospital patient database (via network or WLAN), patient data can be filled in automatically when the Patient ID or Visit ID is entered.

  • Page 32: Barcode Reader

    When a Barcode reader is connected, the patient data is read from the Barcode (generated by the hospital system). If an external hospital patient database is available, all patient data is entered in the patient data fields of the CardioPulse Prime as described on the previous page.

  • Page 33: Electrode Placement

    A minimal resistance between skin and electrode is required to obtain the best ECG signal and ensure the highest quality ECG recording. Therefore, please note the following points: Only use electrodes that are recommended by Spacelabs Healthcare (see acces- sories) Before using disposable electrodes, check that the expiration date has not yet passed.

  • Page 34: Electrode Identification And Color Code

    Electrode placement Electrode Identification and Color Code CardioPulse Prime Electrode Identification and Color Code The electrode color codes in the following sections correspond to Code 1 (IEC) for the graphics and to Code 2 (AHA) in the tables IEC label...

  • Page 35: Standard 10-Lead Resting Ecg

    Electrode placement CardioPulse Prime User guide Standard 10-lead resting ECG Standard 10-lead resting ECG V1 red V2 yellow V3 green V4 blue V5 orange V6 violet RA white LA black LL red RL green 4.3.1 Electrode placement for standard leads...

  • Page 36: Standard (V4R)

    Electrode placement Standard (V4r) CardioPulse Prime Standard (V4r) ACC/AHA guidelines recommend examining patients suffering from a myocardial infarction with inferior ST elevation for possible RV ischemia or RV infarction; this examination should be performed with a right precordial V4r lead.

  • Page 37: Balanced

    Electrode placement CardioPulse Prime User guide Balanced Balanced V7 blue V8 orange V9 violet V4r green V3r yellow V1 red L black RA white RL green LL red Balanced 10-wire Cable AHA label Electrode placement V1 brown / red  Fourth intercostal space at the right sternal border.

  • Page 38: Left Posterior V7-V9

    Electrode placement Left posterior V7-V9 CardioPulse Prime Left posterior V7-V9 If an acute coronary occlusion is strongly suspected, it is recommended to also register posterior chest wall leads V7 to V9) V4 brown/blue V7(V1 brown/red) V5 brown/orange V8(V2 brown/yellow) V6 brown/violet...

  • Page 39: Nehb Leads

    Electrode placement CardioPulse Prime User guide Nehb leads Nehb leads The Nehb leads are bipolar chest leads. They are of special interest for the diagnosis of changes in the posterior ventricle wall. Three leads are arranged in the form of a triangle, also called the “small cardiac triangle”.

  • Page 40: Pediatric

    Electrode placement Pediatric CardioPulse Prime Pediatric C2 Yellow C7 Red V3 Green C5 Orange V6 Violet V4 Blue R White L Black N Red F Green IEC label AHA label Electrode placement C4r white / brown V4 brown / blue ...

  • Page 41: Right Precordials (C3R-C6R)

    Electrode placement CardioPulse Prime User guide Right precordials (C3r-C6r) Right precordials (C3r-C6r) Since the treatment of an infarction might depend on the influence of the right ventricle, it is suggested to perform additional recordings with right precordial leads in the case of an acute infarction of the right ventricle's inferior wall (Circulation 2007).

  • Page 42: Skin/Electrode Resistance

    Electrode placement 4.10 Skin/Electrode Resistance CardioPulse Prime 4.10 Skin/Electrode Resistance 4.10.1 Electrode and patient cable check The electrode check is part of step 2 before the start of an ECG recording. The following is checked and displayed: • Excessive noise (signal noise too high) –...

  • Page 43: Lead Sequence/Lead View

    Electrode placement CardioPulse Prime User guide Lead sequence/lead view 4.11 4.11 Lead sequence/lead view 4.11.1 Setting Standard or Cabrera lead sequence  The lead sequence is defined in the settings. (Menu > Settings > ECG > Leads & cable).  In the Lead menu, select between Standard and Cabrera.

  • Page 44: Resting Ecg

     Do not operate the unit if the earth connection is suspect or if the AC power lead is damaged or suspected of being damaged.  If an external electronic device is connected to the CardioPulse Prime, use the potential equalisation stud for earth protection.

  • Page 45: Resting Ecg - Procedural Flow Diagram

    Resting ECG CardioPulse Prime User guide Resting ECG - Procedural Flow Diagram Resting ECG - Procedural Flow Diagram • Lead configuration, ECG  Basic settings cable  Entering patient data or Prepare the patient, connect the retrieving patient data Resting electrodes and switch on the device •...

  • Page 46: Printing, Saving And Transferring Automatically

    Resting ECG Resting ECG - Procedural Flow Diagram CardioPulse Prime 5.1.1 Printing, saving and transferring automatically Menu > Settings > General > Workflow Activate Print after acquisition, Transmit after acquisition and Delete after transmission to automatically print and transmit a saved recording or to delete recordings after transmission.

  • Page 47: Automatic Resting Ecg Recording

    Resting ECG CardioPulse Prime User guide Automatic resting ECG recording Automatic resting ECG recording To take an automatic ECG recording, press the Auto key. After approx. 10 seconds, the recording is analyzed and the result displayed. The recording can be checked and saved and further printouts can be obtained in different formats.

  • Page 48: Automatic Printout

    Resting ECG Automatic resting ECG recording CardioPulse Prime 5.2.1 Automatic printout The printout gives the following: • Heart rate • Patient name and ID • Date and time • Speed • Sensitivity • Filter • Device ID • Serial number •...

  • Page 49: Manual Rhythm Printout

    Resting ECG CardioPulse Prime User guide Manual Rhythm Printout Manual Rhythm Printout • Use this function to print a real-time ECG. The print parameters such as lead se- quence, print speed and sensitivity can be changed by the user during the printout.

  • Page 50: Rhythm Recording

    Resting ECG Rhythm recording CardioPulse Prime Rhythm recording Press Rhythm to perform a rhythm recording. Select the recording duration in the dialogue that pops up. If a recording is canceled after more than 10 seconds, it can still be stored. The recording can be checked and saved and further printouts can be obtained in different formats.

  • Page 51: Changing The Ecg Display

    Resting ECG CardioPulse Prime User guide Changing the ECG display Changing the ECG display The ECG preview is optimized for one or two columns with 6 leads each, or for 3 columns with 4 leads each. The amplitude and speed can be set to 5, 10 or 20 mm/ mV, and to 12,5, 25 or 50 mm/s.

  • Page 52: Myogram (Low Pass) Filter

    Resting ECG Changing the ECG display CardioPulse Prime 5.5.2 Myogram (low pass) filter The Myogram (low pass) filter suppresses disturbances caused by strong muscle tremor. In Menu > Settings > ECG > Filters & formulas, the Myogram filter is defined.

  • Page 53: Memory

    Memory CardioPulse Prime User guide Saving a Recording 6 Memory Recordings can be stored locally and/or transmitted automatically to Schiller Link or Server. Recordings stored in the memory can be viewed, printed, transmitted or deleted at any time. Saving a Recording Recordings are stored manually after completion of the acquisition.
  • Page 54 Memory Editing the memory CardioPulse Prime Search recordings Select recordings with: Sort by: Sort order: time: Start time up sort Clear Select all Deselect Clear Upload View selection Deleting the selected recordings Upload the selected recordings Select all recordings Deselect selected recordings...

  • Page 55: Opening The Print Preview From The Memory And Printing A Recording

    Memory CardioPulse Prime User guide Editing the memory 6.2.1 Opening the print preview from the memory and printing a recording Depending on the settings in Menu > Settings > General > Workflow, the recording is printed automatically as soon as it has been saved.

  • Page 56: Transmitting And Deleting Stored Recordings

    Memory Editing the memory CardioPulse Prime 6.2.2 Transmitting and deleting stored recordings Depending on the settings in Menu > Settings > General > Workflow (see Page 76), the recording is transmitted and deleted automatically as soon as the recording has been finished.

  • Page 57: Worklist (Option)

    To receive a worklist from the Schiller Server, the unit identification of the CardioPulse Prime (device ID in the system) must be the same as the one defined for the Schiller Server. This is usually set when the unit is first commissioned. The Device ID is shown in Menu >...

  • Page 58: Receiving A Worklist

    Worklist (Option) Receiving a worklist CardioPulse Prime Receiving a worklist To open the worklist proceed as follows: 1. Press Menu > Worklist. Select a recording Search recordings Search for PID, Visit ID, first name or last name Work item details Worklist Sync.
  • Page 59 Worklist (Option) CardioPulse Prime User guide Receiving a worklist All patients given in the worklist are displayed with their last/first name, patient ID, order ID and room number. The following recording types are available: • Resting ECG • Resting rhythm •...

  • Page 60: Taking A Worklist Recording

    Worklist (Option) Receiving a worklist CardioPulse Prime 7.2.1 Taking a Worklist Recording • This procedure corresponds with the worklist mode “Record from worklist”, see setting section 8.7 General, page 76, workflow. • Patient data provided by the HIS cannot be edited (except for height and weight).

  • Page 61: Performing A Recording From Work Order Details

    Worklist (Option) CardioPulse Prime User guide Receiving a worklist 7.2.2 Performing a recording from work order details • This procedure corresponds with the worklist mode “Record from work order details”, see setting section 8.7 General, page 76, workflow. • Patient data provided by the HIS cannot be edited (except for height and weight).

  • Page 62: Sending Worklist Recordings To The His

    Worklist (Option) Receiving a worklist CardioPulse Prime 7.2.3 Sending worklist recordings to the HIS • It is possible to automatically send performed worklist recordings. This is defined in system settings (Menu > Settings > General > Workflow > Transmit after ac- quisition Page 76).

  • Page 63: General And System Settings

    General and System Settings CardioPulse Prime User guide Navigation 8 General and System Settings Navigation When pressing the Menu key , the option Settings is displayed. Main menu Patient cable Lead & Cable Lead sequence Standard Filter & Formulas Worklist...

  • Page 64: Overview Menu > Settings

    General and System Settings Navigation CardioPulse Prime 8.1.1 Overview Menu > Settings This menu can be protected with a password via the menu Settings > General > Access control. Settings overview Menu Settings Sub-menu • Lead & Cable • Filter & Formulas •...

  • Page 65: Saving And Restoring Settings

    General and System Settings CardioPulse Prime User guide Navigation 8.1.2 Saving and restoring settings Changed settings are saved automatically. In Menu > Settings, settings from another device can be imported, or a backup of the settings can be restored (see Page 63).

  • Page 66: Ecg Menu

    General and System Settings ECG Menu CardioPulse Prime ECG Menu 8.2.1 Lead & Cable Menu Parameter Description / selection Patient cable IEC or AHA Lead sequence Standard or Cabrera Lead configuration. Use the function key Leads to de-/activate leads, and change their order with Up/Down: Lead &...

  • Page 67: Additional Leads

    General and System Settings CardioPulse Prime User guide ECG Menu 8.2.4 Additional Leads Standard leads per lead configuration These settings apply to current resting rhythm recordings and recordings from the memory as well as the printout. Therefore, saved ECGs can be displayed or printed with different settings at any time.

  • Page 68: Menu Reports

    1. Name of the logo “reportlogo.png”. Accepted file types are jpg, jpeg, png, bmp or Company logo gif. 2. Connect the USB stick containing the file “reportlogo” to the CardioPulse Prime. 3. Press function key “Import logo”. “reportlogo” is loaded and displayed. Yes/No...

  • Page 69: Manual Printout

    General and System Settings CardioPulse Prime User guide Menu Reports 8.3.4 Manual printout In this menu, the default settings for manual printouts are defined. Parameter Description Selection of the lead group: Default lead group All, extremities or precordials 5, 10, 50 mm/mV Default amplitude [mm/mV] 12.5, 25 or 50 mm/s...

  • Page 70: Resting Ecg

    General and System Settings Menu Reports CardioPulse Prime 8.3.5 Resting ECG Saved ECGs can be displayed with different settings at any time. • Patient data is always printed. • The order listed below can vary. • Select (), activate/deactivate with OK or with function key , sort with keys Up/Down and Average/Rhythm amplitude 5/10/20 mm/mV.

  • Page 71: Rhythm Ecg

    General and System Settings CardioPulse Prime User guide Menu Reports 8.3.6 Rhythm ECG Saved ECGs can be displayed with different settings at any time. • The order listed below can vary. • Select (), activate/deactivate with OK or with function key...

  • Page 72: Menu Layouts

    General and System Settings Menu Layouts CardioPulse Prime Menu Layouts In this menu, the views and layouts for Preview and the ECG review can be set. 8.4.1 Resting Preview Rhythm ECG Resting ECG Preview review review Menu Parameter Description View order Select whether Hookup or Recorder is shown at the top.

  • Page 73: Worklist

    General and System Settings CardioPulse Prime User guide Menu Layouts Rhythm ECG review Rhythm ECG r Resting ECG Preview eview review These settings apply to current resting rhythm ECG recordings and recordings from the memory. Therefore, saved ECGs can be displayed with different settings at any time.

  • Page 74: Connectivity

    General and System Settings Connectivity CardioPulse Prime Connectivity 8.5.1 EMR integration Menu Parameter Description / selection None – No input field displayed EMR integration Schiller Link (EMR = electronic medical – Device ID is displayed record system) Schiller Server – Host, port, user and password input fields are displayed. (See fol-...

  • Page 75: Wlan

    General and System Settings CardioPulse Prime User guide Connectivity 8.5.3 WLAN To select a WLAN network, press the function key “Browse networks”, select your network and confirm with the OK key. Once all parameters have been set, press the "Apply" function key...
  • Page 76 General and System Settings Connectivity CardioPulse Prime Advanced General Advanced Network Menu Parameter Description / selection “Yes” = if you want the SSID to be hidden in the Wifi network. Hidden “No” = if you want the SSID to be visible in the Wifi network.

  • Page 77: Regional Settings

    General and System Settings CardioPulse Prime User guide Regional settings Regional settings Sub-menu Parameter Description / selection • Date format (dd.mm.yyyy / yy-mm-dd / mm/dd/yyyy) • Time format (HH:mm:ss/h:mm:ss) • Time zone • Date and time settings (manual setting is only possible when...

  • Page 78: General

    General and System Settings General CardioPulse Prime General Menu Parameter Description / selection Various parameters Software and hardware versions are displayed. Info A diagnostic file (.nfo) is written to the connected USB Information Send info to USB USB memory stick.
  • Page 79 General and System Settings CardioPulse Prime User guide General Menu Parameter Description / selection • Basic Login when switching on the device and/or menu setting with pass- word Access Control Mode • Local (Default factory setting) Definition of users, passwords and privileges locally on the device •...
  • Page 80 General and System Settings General CardioPulse Prime Menu Parameter Description / selection Automatic log off Yes/No Automatic logout activated (Only displayed when access control is activat- Timeout logout [s] Page 78...

  • Page 81: Setting User Name And Password For Access Control

    General and System Settings CardioPulse Prime User guide General 8.7.1 Setting user name and password for access control  To prevent non-authorized users to access patient information, manipulate settings or the software, we strongly recommend changing the default password to a strong password according to the standard rules.

  • Page 82: Transmission - Overview

    Transmission Options With the CardioPulse Prime, transmission is possible via a network or Wi-Fi. The transmission options are as follows:  When a non-medical device is connected to the interface, ensure that both units are securely connected to the same earth potential.

  • Page 83: Automatic Transmission

    Transmission - Overview CardioPulse Prime User guide Transmission Options Wifi When Wifi is set, the symbols are as follows: • Symbol Green - Connected to Wifi network and Server. • Symbol Black - Connected to network but no connection with Server •...
  • Page 84 Transmission - Overview Transmission Options CardioPulse Prime Activate PDF export in the Menu > Settings > Workflow > PDF to USB after save. If PDF export is active, the recordings from the memory are transmitted as soon as a USB stick is connected. The symbol PDF export is displayed when data has successfully been transferred to the memory stick.

  • Page 85: Schiller Link

    3. Upload the GDT file into the import folder of the Schiller Link service Room 4. Start and check the order incl. patient data on the CardioPulse Prime. Should no patient data be displayed, press the function key "Use order data". The order data will be loaded and displayed.

  • Page 86: Retrieving Data From The Schiller Server

    Patient data can automatically be retrieved from the Schiller Server to the CardioPulse Prime. This is called patient data query (PDQ). To do this, the Patient or Visit ID is entered in the patient data screen manually or via a barcode reader (see Page 30).

  • Page 87: 10 Maintenance

    Service/Shelf life Self life-Service Life The shelf life and service-life of the CardioPulse Prime is based on the battery since it has the shortest shelf life and service life than the components and accessories of the CardioPulse Prime. The other components and accessories of the CardioPulse Prime are durable and have a low likelihood of time-dependent product degradation.

  • Page 88: Visual Inspection

     No kinks, abrasion or wear in any cable assembly.  Input/output connectors (undamaged). In addition to the visual inspection, switch on the CardioPulse Prime, scroll through the menu and test some sample functions. In this way, you can check that: •...

  • Page 89: Cleaning The Casing And Cables

    • Confirm that all connectors engage securely. The casing of the CardioPulse Prime and the cable assemblies can be cleaned with a cloth slightly moistened (not wet) on the surface only. If necessary, a domestic non- caustic cleaner or a 50 % alcohol solution can be used to remove grease stains and finger prints.

  • Page 90: Cleaning The Cable Assembly

    Maintenance 10.4 Cleaning the casing and cables CardioPulse Prime 10.4.1 Cleaning the cable assembly 1. Before cleaning, inspect the cable for damage. Gently bend and flex all parts of the cable. Inspect for splits in the sheathing, damage or extreme wear, exposed wires or bent connectors.

  • Page 91: Disinfection

    Maintenance CardioPulse Prime User guide Disinfection 10.5 10.5 Disinfection Disinfection removes certain bacteria and viruses. Please refer to the manufacturer's information. Use commercially available disinfectants intended for clinics, hospitals and medical practices. Disinfect the device in the same way as described for cleaning the device (previous page).

  • Page 92: Battery

    Maintenance 10.7 Battery CardioPulse Prime 10.7 Battery • No maintenance is required for the lithium-ion batteries. • Based on its use, the battery needs to be replaced every 4 years when operation time has fallen under 6 hours. • Storage and operation conditions outside the temperature range of 59-77 °F will reduce the service life of the battery! •...

  • Page 93: Inspection Report

    12 months) Inspection carried out by:      In case of a defect, please contact the service department of your hospital , your Spacelabs Healthcare representative  or the local after-sales service . Name: ............................Page 91...

  • Page 94: Lifed-Item Replacement Every 3 - 5 Years

    Maintenance 10.8 Inspection Report CardioPulse Prime 10.8.1 Lifed-item replacement every 3 - 5 years Inspection Results Replacement Internal battery  Replace internal battery if opera- • Unit sent to Spacelabs Health-      tion falls substantially under six (6) care service center for accumula- hours.

  • Page 95: 11 Trouble Shooting

    Healthcare representative. • Incorrect settings for patient  Change the sensitivity setting.  Check the electrode contact and re-apply the electrodes.  If the problem persists, call your local Spacelabs Healthcare repre- QRS traces overlap • Poor electrode contact sentative.
  • Page 96 • Old paper inserted  Ensure that new original paper is inserted.  Note that the CardioPulse Prime thermal paper is heat- and light- sensitive. If it is not stored in its original seal, stored in high tem- Printout fades, is not peratures or is simply old, print quality can deteriorate.

  • Page 97: Preventing Electromagnetic Interferences

    The user can help avoid electromagnetic disturbances by keeping the minimum distance between portable and mobile radio frequency (RF) telecommunication devices (transmitters) and the CardioPulse Prime. The distance of 0.3 m depends on the output performance/frequency of the communication device as indicated below.

  • Page 98: Measures To Prevent Electromagnetic Interference

    Trouble Shooting 11.2 Preventing electromagnetic interferences CardioPulse Prime 11.2.1 Measures to prevent electromagnetic interference In the case of certain electromagnetic interference, artefact's can occur, which are distinguishable from the ECG signal. The essential performance characteristics of the device are not affected by these artefact's, but the user can take the following...

  • Page 99: Accessories And Disposables

    Accessories and disposables  Always use Spacelabs Healthcare spare parts and disposables or products approved by Spacelabs Healthcare. Failure to do so may endanger life and/or invalidate the warranty. Your local representative stocks all the disposables and accessories available for the CardioPulse Prime.

  • Page 100: Thermal Chart Paper

    Trouble Shooting 11.3 Accessories and disposables CardioPulse Prime REF no.: CAT no.: Article 2.300016 AC power cable Japan, 90 ° angled, 2.5m 2.300024 161-0278-00 AC power cable USA (hospital grade), 90 ° angled, 2.5m 2.300025 AC power cable Brazil, 90 ° angled, 2.5m 11.3.4...

  • Page 101: 12 Technical Data

    Technical Data CardioPulse Prime User guide Device 12.1 12 Technical Data 12.1 Device Dimensions 15.1 x 12.56 x 3.54 in, approx. 9.92 pound including thermal paper Ambient conditions Operating temperature • 50 to 104 °F Relative humidity during operation •...
  • Page 102 Technical Data 12.1 Device CardioPulse Prime Interfaces • ECG cable interface • Potential equalisation • Network connection (1Gbit) • 2 USB • 2 RS-232 port is not intended for US market Memory Memory for at least 350 ECG recordings, 100 resting rhythm recordings...

  • Page 103: Ecg

    Technical Data CardioPulse Prime User guide 12.2 12.2 Patient input • Fully floating and isolated, defibrillation-protected (only with original Spacelabs Healthcare patient cable) Lead configuration • Standard 12-lead • Right precordials • Standard C4r • Left Posterior • Nehb • Pediatric •...

  • Page 104: Safety Standards

    Technical Data 12.3 Safety Standards CardioPulse Prime 12.3 Safety Standards Safety standard IEC/EN 60601-1 IEC/EN 60601-2-25 IEC/EN 60601-1-2 The device can be exposed to the following source of interference without impair- ment of the essential performance: • Static discharges up to 15 kV •...

  • Page 105: Emc Information

    Technical Data CardioPulse Prime User guide EMC information 12.5 12.5 EMC information The unit meets the Collateral Standards of Electromagnetic compatibility – Require- ments and tests IEC/EN 60601-1-2 the limits and methods of measurement of elec- tromagnetic disturbance characteristics of industrial, scientific and medical radio fre- quency equipment.
  • Page 106 Technical Data 12.5 EMC information CardioPulse Prime Immunity Test IEC 60601-1-2 Test Level Compliance Level Electromagnetic environment guidance Portable and mobile communications equipment should be used no closer to any part of this device, including cable, than the recommended separation distance (d) calculated from the equa-...

  • Page 107: Immunity To Proximity Fields From Rf Wireless Communications Equipment

    Technical Data CardioPulse Prime User guide EMC information 12.5 12.5.1 Immunity to proximity fields from RF wireless communica- tions equipment Test max. Modulation Distance d Immunity Band frequency Service power P level [V/m] [MHz] [MHz] Pulse Various transmitting services 380-390...
  • Page 108 Technical Data 12.5 EMC information CardioPulse Prime Blank page Page 106...

  • Page 109: 13 Index

    Automatic printout ......Lead group ........Manual printout ....... Resting ECG - Procedural Flow Diagram . Cabrera lead sequence ....Cabrera lead sequence - setting .... CardioPulse prime elements ....Celsius ........... Cleaning ..........Safety notes ..........Connections ........... Sequential ........
  • Page 110 Index CardioPulse Prime Blank page Page 108...

  • Page 111: 14 Appendix - Symbols

    Appendix - Symbols 14 Appendix - Symbols This appendix lists all general symbols that may be present on the device, label and accessories. Not all of those symbols are necessarily present on your device. Identification of the manufacturer Identification of the manufacturing date Identification of the distributor Identification o070-3062-00f the importer Medical device...
  • Page 112 Appendix - Symbols Regulatory Compliance Mark for the Australian standards The device is recyclable Symbol for the recognition of electrical and electronic equipment. Device must not be disposed of in the household waste. Symbol for the recognition of a battery. Battery must not be dis- posed of in the household waste.
  • Page 113 Appendix - Symbols Keep away from sunlight (protect from direct sunlight) Fragile, handle with care Transport upwards (this way up) Do not use hooks EIP = electronic information product (dos not contain any toxic and hazardous substances or elements above the maximum concentra- tion values (product can be recycled and re-used).
  • Page 114 Appendix - Symbols Blank page...

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