MicroPace OneStim-CRM User Instruction Manual
  1. Manuals
  2. Brands
  3. MicroPace Manuals
  4. Medical Equipment
  5. OneStim-CRM
  6. User instruction manual

MicroPace OneStim-CRM User Instruction Manual

Cardiac stimulator / recorder
Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
USER INSTRUCTION MANUAL
OneStim-CRM
Cardiac Stimulator / Recorder

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the OneStim-CRM and is the answer not in the manual?

Questions and answers

Related Manuals for MicroPace OneStim-CRM

Summary of Contents for MicroPace OneStim-CRM

  • Page 1 USER INSTRUCTION MANUAL OneStim-CRM Cardiac Stimulator / Recorder...
  • Page 2 Tachbrook Park, Warwick, CV34 6WE, UK Swiss AR Services AG Industriestrasse 47, CH-6300 Zug, Switzerland www.onestim.io/IFU www.micropaceep.com/company/quality-regulatory Micropace Cardiac Stimulator OneStim User Instruction Manual MP4006-CRM Release V4.1, Date: 03 April 2024 Applies to OneStim Software 1.28 Ref: R_OneStim Technical UIM 4.1-All.docx https://micropaceep.com/customer-...

  • Page 3: Table Of Contents

    OneStim User Instruction Manual CONTENTS INTRODUCTION ..........................5 Device Description ......................5 Glossary and Terms ......................5 ESSENTIAL PRESCRIBING INFORMATION ................6 Intended use ........................6 Indications for Use ......................6 Intended Operating Environment and Users ..............6 Intended Patient Population ....................6 Contraindications .......................6 Clinical Benefits .........................6 Compatible Equipment ......................7 Important Patient Safety Warnings ...................7 General Precautions in Handling OneStim ...............9...
  • Page 4 OneStim User Instruction Manual 15.2 Maintenance and Calibration ..................29 15.3 Cleaning Instructions ...................... 29 15.4 Service, Serviceable Life and Disposal ................29 16. Explanation of Symbols ......................30 17. Electromagnetic Interference (EMI) and Compatibility .............. 33 17.1 EMI Warnings ......................... 33 17.2 Cable Lengths ........................

  • Page 5: Introduction

    OneStim User Instruction Manual 1. INTRODUCTION 1.1 Device Description OneStim is a portable diagnostic programmable cardiac stimulator with an integrated ECG display for performing simple cardiac electrophysiological investigations. The portable stimulator has four channels for cardiac stimulation and electrogram recording together with 5 or 12 Lead surface ECG.

  • Page 6: Essential Prescribing Information

    3.7 million EP studies with no reported deaths or significant adverse events caused by the Micropace device, This offers a very high favourable risk-benefit ratio, a characteristic common to the whole class of diagnostic cardiac stimulators.

  • Page 7: Compatible Equipment

    OneStim User Instruction Manual 2.7 Compatible Equipment Micropace OneStim Cardiac Stimulator is intended for use with the following equipment: Diagnostic and Ablation pacing electrode catheters and Pacing leads  Any currently available legally marketed electrophysiological diagnostic pacing and sensing electrode catheters exhibiting a tissue contact impedance of between 200Ω to 2000Ω at nominal stimulation current of 5 mA or 5 Volts, verified prior to use to be able to reliably capture the heart rhythm for diagnostic purposes.

  • Page 8: Warning: Disconnect Patient's Pacing Catheters From Stimulator Output In Case Of Unexpected Onestim Behaviour

    OneStim User Instruction Manual  Patients undergoing cardiac EP studies may experience unexpected bradycardia, asystole or tachy-arrhythmias during the study spontaneously or due to electrical or mechanical stimulation, ablation and post defibrillation.  OneStim may unintentionally stimulate the heart due to software, hardware or human error and induce dangerous arrhythmias.

  • Page 9: General Precautions In Handling Onestim

    Caution: Precautions prior to use  Do not use the OneStim if any component appears damaged or device appears to start up with error messages. If in doubt, contact the Distributor or Micropace directly via contact details on underside of device. ...
  • Page 10 OneStim User Instruction Manual use or an estimated 6 hours of typical intermittent use with power saving sleep states enabled.  To avoid overheating of OneStim, keep air vents on the left side and under the device unobstructed - place device on a hard surface when in use, not of soft surfaces such as a bed.

  • Page 11: Device Ratings, Classification And Certification

    Operating Temperature Range: +5ºC to +35ºC  Operating Relative Humidity Range: 30% to 80% RH Copyrights ‘OneStim’© trademark and software copyright 1994-2023 owned by Micropace Pty Ltd. ‘Microsoft© Windows© CE trademark and copyright owned by Microsoft Corporation. Page 11 of 36...

  • Page 12: Onestim Description And Connections

    OneStim is shipped with following components. Unpack and check for visible damage prior to installation. Part Number Part Name Part Description Length MP4011-2BC OneStim-CRM Cardiac OneStim-CRM Console 2 Channel Stimulator MP4075-2B Patient Connection Box 2CH Patient Connection Box 2 Channel 2.5 m MP4105 ECG Cable, 10 lead ECG Cable, 10 lead Integrated IEC 4.6 m...

  • Page 13: Device Description

    OneStim User Instruction Manual 4.2 Device Description Wake Button Patient Connection Box OneStim Console Emergency Pacing Channel Outlets Eyelet for securing to Emergency patient’s bed Pacing Status sheets Emergency Battery Status Battery Status Figure 1: OneStim Product Appearance Wake Button Surface ECG Cable Input Patient Connection Box...

  • Page 14: Assembling / Installing The Onestim Stimulator Console

    OneStim User Instruction Manual Figure 2: OneStim Product Connection Ports 4.3 Assembling / installing the OneStim Stimulator Console  Connect Power Supply to mains power outlet to operate device and charge battery (4 hours to charge fully), or operate device on battery. ...

  • Page 15: Connecting Onestim To The Patient - Pace Mode

    OneStim Console OneStim MP4011 Connection Splitter Cable e.g. Micropace PSA Patient SmartLINK Cable Figure 4: Example of Patient connections to pacing lead 5. OneStim Basic Operation 5.1 PACE Mode Main Screen The PACE Mode is a simplified interface with limited voltage controlled stimulation intended for measurement of cardiac conduction using permanent pacing leads at different locations and intra-cardiac and surface electrocardiograms, prior to pacing lead implantation.

  • Page 16: Ecg Signals

    OneStim User Instruction Manual PACE Mode Main Screen has the following controls. Trace Page Select For Urgent Pacing, Stim and detected QRS press for 3 seconds. indicator trace Trace select, move and scale QRS/ Trigger ECG review 14 Electrogram Menu Traces Stimulation Channel...

  • Page 17: Ecg Trace

    OneStim User Instruction Manual 6.2 ECG Trace Page Menu The ECG Trace Page menu allows you to select and save different trace pages. Trace pages allow the user to customise the displayed waveforms, their scale and positions. You can modify, rename and save each of the 5 trace pages.

  • Page 18: Selecting Stimulation Channel

    OneStim User Instruction Manual 2. 1stS1: synchronizes onset of pacing (1st S1) to be a set delay after first sensed QRS, following which stimulation is asynchronous (VOO/AOO). 3. Inhibited: each S1 is inhibited if earlier QRS is sensed in ECG indicated by Flash “Inhibited”.

  • Page 19: Performing Diagnostic Stimulation

    OneStim User Instruction Manual 7. Performing Diagnostic Stimulation 7.1 Pace Mode Pacing Protocols Pacing Protocol menu may be displayed by prolonged press of S1 button, containing the following protocols: Pace: default regular pacing also performed when no Pacing Protocol Menu is displayed, with default S1 lower limit of 300 ms, configurable down to 280ms.

  • Page 20: Qrs /Trigger Submenu

    OneStim User Instruction Manual 8. QRS /Trigger Submenu: This menu provides navigation to Configuration and Help pages and QRS display in a triggered sweep page. QRS Detection menu allows synchronization of start of pacing to sensed ECG as in EP Mode. 8.1 QRS Trigger Page Pause/ Play...

  • Page 21: Urgent Pace

    OneStim User Instruction Manual 8.2 Urgent Pace For urgent physiological pacing, no matter which protocol and what parameters are set at the time, press and hold ‘Urgent Pace’ for 3 seconds – OneStim will enter Urgent Pace Protocol, stimulating at 600ms into all channels at a higher current.
  • Page 22 OneStim User Instruction Manual Then touch the S1 field: Page 22 of 36...

  • Page 23: Reviewing And Saving Ecg

    OneStim User Instruction Manual 10. Reviewing and Saving ECG The Review Page selected by ‘Review’ button is used to review and export events of interest from the study. 10.1 Signal Review Page Captured ECG may now be reviewed and analysed. Position and size of traces on the screen may be adjusted by: Swiping left or right on the trace to pan sideways.

  • Page 24: Figure 8 Review Template/Freeze Column

    OneStim User Instruction Manual Figure 8 Review Template/Freeze column  Pressing the 'PIN' icon in the Trace Page menu freezes the leftmost area of ECG indicated by dashed line as a Template. Press icon again to delete template.  The saved Template may be displayed in the Live Screen by the ‘PIN’...

  • Page 25: Saving And Recalling Data

    OneStim User Instruction Manual 10.3 Saving and Recalling Data The SAVE button will save review data to an inserted USB Drive (format must be FAT32), or if absent, then to internal storage. The complete ECG buffer data along with Date/Time, the last Stimulation protocol and entered Comments are saved and the visible screen is also saved as a printable PDF file.

  • Page 26: Using The Emergency Pacing Output (Epo)

    OneStim User Instruction Manual Figure 11: Example of ECG PDF Printout 11. Using the Emergency Pacing Output (EPO) Emergency Pacing Output (EPO) is an independently battery powered 3. Pacing starts emergency pacing output which remains automatically, available even if OneStim becomes orange light inoperable due to device failure or flashes...

  • Page 27: Device Configuration

    (<50 kΩ) 2. Test Emergency Stimulation by inserting the Micropace Test LED, MP4086, or by shorting outputs with a conductor (paper clip will do) – expect a tone and Pulse light on the Patients Connection Box to flash at 100ppm.

  • Page 28: Software Warning / Error Messages

    OneStim User Instruction Manual 14. Software Warning / Error Messages 14.1 Flash Messages OneStim issues brief 5 second advisory ‘Flash Messages’ in the middle of the screen. These messages are self-explanatory, examples include: Flash Message Meaning & Action F12: Cannot change settings while You must stop pacing before changing some parameters, such pacing! as those in the Configuration Menu.

  • Page 29: Maintenance

    (ii) Dispose of the LiFePO4 battery in an approved disposal or recycling facility. (iii) Dispose of OneStim separately from household waste according to EU WEEE legislation – contact the distributor or Micropace for assistance. (iv) Further technical and service support information is available by request at micropaceep.com.

  • Page 30: Explanation Of Symbols

    OneStim User Instruction Manual 16. Explanation of Symbols Meaning Location Symbol Name Requirement to Requirement to refer to instructions for use refer to instructions prior to use. for use General warning To signify a general warning sign Type CF To identify a defibrillation-proof type CF defibrillator proof applied part complying with IEC 60601-1 On device side...
  • Page 31 OneStim User Instruction Manual Meaning Location Symbol Name Rechargable Indicates the location of the main battery location rechargable battery Indicates the location for the 9 volt battery 9V battery for emergency stimulation On underside of device Crossed-out Do not dispose in general household waste wheeled bin General symbol for To indicate that the rechargeable battery...
  • Page 32 OneStim User Instruction Manual Meaning Location Symbol Name Distributor Distributor of product Importer Importer of product Read Instruction Refer to Instruction for Use for Use Is a Part of Item is a part of named product On Rear of Alternating current Alternating current Device and On Power Supply...

  • Page 33: Electromagnetic Interference (Emi) And Compatibility

    EN 60601-1-2: 2007 WARNING: The use of accessories or cables other than those specified may result in increased emission and/or abnormal function of the Micropace Stimulator. 17.3 EMI / EMC Specifications - Summary OneStim was tested according to IEC 60601-1-2:2014 guided by TR 60601-4-2:2016.

  • Page 34: Onestim Specifications

    OneStim User Instruction Manual 18. OneStim Specifications 18.1 General Specifications V1.5 Parameter Value Power Source Input Class I, 100-240VAC to 18V 60W medical grade Power Supply Rechargeable Battery, LiFePO , 4S2P 12.8V 38.4Wh Power Consumption Normal operation: 15W Average Sleep Mode: <...

  • Page 35: Intra-Cardiac Iecg Specifications

    OneStim User Instruction Manual 18.4 Intra-cardiac iECG Specifications iECG Sensing Parameter Value Channels Equal to Stimulation Channels Input ranges (FSD) ±1 mV to ±16.5 mV Common Mode Range ±0.3V Software display sweep 10, 25, 50, 100, 200 mm/s (additional 2, 5, and 400 mm/s in speeds the review screen and PDF printout) Frequency Filter Settings...

  • Page 36: Ecg Notch Filter

    OneStim User Instruction Manual 18.7 ECG Notch Filter Value ECG Notch Filter Channels When enabled applies to sECG, iECG and Ext. Notch Frequency Selectable 50Hz / 60Hz 18.8 Emergency Stimulation Channel Value Emergency Stimulator Power 9V LiMn Battery, 10 year standby life, >12 hours operation Pacing Activation Activated by connection to intra-corporal pacing electrode pair (activating impedance <50 kΩ...

Table of Contents