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INTRODUCTION

 

 

Page | 39  

 

Date of approval: 

13-SEP-2018

 

UTK: Approval number: 

MR 17488 ANRT 2018

  

Date of approval: 

13-SEP-2018

 

Oman 

Telecommunications Regulatory Authority

 

WAM : R/6168/18 

D172250 

UTK: R/6164/18 

D172250 

Paraguay 

Comisión Nacional de 
Telecomunicaciones 

NR:121/2019 (WAM) 
NR:122/2019 (UTK) 

Pakistan 

Pakistan Telecom Authority

 

 

Philippines 

National Telecommunications 
Commission 

 

WAM

: ESD-18-18399C 

UTK

: ESD-19-19449C 

 

Singapore 

Info-Communications Media 
Development Authority (IMDA) 

 

South 
Korea 

Korea Communications Commission 

(

대한민

 

국

 

방송통

 

신위원

 

회

) – 

KCC 
Certification number: 

WAM

: IC MSIP-CRI-S83-WAM 

UTK

: IC MSIP-CRI-S83-UTK 

 

 

 

This equipment is Industrial (Class A) electromagnetic wave 
suitability equipment and seller or user should take notice of it, 
and this equipment is to be used in the places except for home. 

이

 

기기는

 

업무용

(A

급

) 

전자파적합기기로서

 

판

 

매자

 

또는

 

사용자는

 

이

 

점을

 

주의하시기

 

바라

 

며

, 

가정외의

 

지역에서

 

사용하는

 

것을

 

목적으로

 

합니다

. 

 

Class A Equipment (Industrial Broadcasting & Communication 
Equipment)           

A

급

 

기기

 (

업무용

 

방

 

송통신기자재

) 

 

 

UAE 

 

WAM

: ER65767/18 

UTK

: ER65804/18 

 

 

 

Содержание RScribe

Страница 1: ...h Allyn RScribe 12 LEAD electrocardiograph SYSTEM USER MANUAL Manufactured by Welch Allyn Inc Skaneateles Falls NY U S A CAUTION Federal law restricts this device to sale by or on the order of a physi...

Страница 2: ...tered trademark of the National Electrical Manufacturers Association for its standards publications relating to digital communications of medical information Citrix and Citrix XenApp are registered tr...

Страница 3: ...ONS 14 INSPECTION 14 CLEANING AND DISINFECTING 14 DISPOSAL 14 ELECTROMAGNETIC COMPATIBILITY EMC 15 REGULATORY RADIO COMPLIANCE 19 INDUSTRY CANADA IC EMISSIONS 20 EUROPEAN UNION 21 INTRODUCTION 23 MANU...

Страница 4: ...TIENT DEMOGRAPHIC ENTRY 52 STAT ECG 52 START A RESTING EXAM 52 ECG ACQUISITION PRINTING AND STORAGE 54 DISPLAY OVERVIEW 54 ACQUIRE ECGS 56 CONTEXT MENUS 60 CONTEXT MENU SETTINGS 60 EXAM SEARCH 65 SELE...

Страница 5: ...age 3 SERVICE LOGS 85 CONFIGURE WORKFLOW 86 USER PREFERENCES 87 RSCRIBE WILL PRESENT THE DEFAULT SETTINGS ON ANY OF THE WORKSTATIONS THAT THE USER LOGS INTO 87 REPORT CONFIGURATION TOOL 88 USER ROLE A...

Страница 6: ...d for activation upgrade and customer service Copyright and Trademark Notices This document contains information that is protected by copyright All rights are reserved No part of this document may be...

Страница 7: ...he Product s e Alterations and or modifications to the Product s not authorized by Welch Allyn f Other events outside of Welch Allyn s reasonable control or not arising under normal operating conditio...

Страница 8: ...S NOTICED AND WELCH ALLYN IS NOTIFIED WITHIN THE WARRANTY PERIOD IN NO EVENT INCLUDING THE CLAIM FOR NEGLIGENCE SHALL WELCH ALLYN BE LIABLE FOR INCIDENTAL SPECIAL OR CONSEQUENTIAL DAMAGES OR FOR ANY O...

Страница 9: ...n direct patient contact must be in compliance with UL 60601 1 IEC 60601 1 and IEC 60601 2 25 Only use parts and accessories supplied with the device and available through Welch Allyn Inc 5 Patient ca...

Страница 10: ...uld be removed from the patient promptly following testing Do not mix electrodes made of dissimilar metals 16 To avoid potential for spread of disease or infection single use disposable components e g...

Страница 11: ...ually A functional test should be executed after update which includes acquiring a recording editing measurements and printing a report as well as importing an order and exporting results if activated...

Страница 12: ...eously with the device however disturbance to the signal may occur 7 If an electrode is not properly connected to the patient or one or more of the patient cable lead wires is damaged the display will...

Страница 13: ...ns must be adhered to Ambient temperature 20 C to 65 C 4 F to 149 F Relative humidity 10 to 95 non condensing 18 Allow the device and any computer equipment used to stabilize within its intended opera...

Страница 14: ...actices that could result in damage to the equipment or other property or loss of data PC USB connection to PC Defibrillator proof type CF applied part Do not dispose as unsorted municipal waste Requi...

Страница 15: ...EQUIPMENT SYMBOLS AND MARKINGS Page 13 Package Symbol Delineation This side up Fragile Keep Dry Keep Away from Heat Acceptable Temperature Range...

Страница 16: ...ent acquisition module cables and lead wires wipe exterior using Clorox Healthcare Bleach Germicidal Wipes use according to instructions on product label or a soft lint free cloth with a solution of S...

Страница 17: ...601 1 2 The device should not be used adjacent to or stacked on top of other equipment If the device must be used adjacent to or stacked on top of other equipment verify that the device operates in an...

Страница 18: ...is used in such an environment Emissions Test Compliance Compliance Level Electromagnetic Environment Guidance Electrostatic discharge ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air Fl...

Страница 19: ...r and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each...

Страница 20: ...aximum Output Power of Transmitter W Separation Distance According to Frequency of Transmitter m 150 KHz to 800 MHz 800 MHz to 2 5 GHz P d 2 1 P d 3 2 0 01 0 1 m 0 2 m 0 1 0 4 m 0 7 m 1 1 2 m 2 3 m 10...

Страница 21: ...h can be determined by turning the equipment off and on the user is encouraged to try and correct the interference by one or more of the following measures Reorient or relocate the receiving antenna I...

Страница 22: ...ce L utilisation de ce dispositif est autoris e seulement aux conditions suivantes 1 il ne doit pas produire de brouillage et 2 l utilisateur du dispositif doit tre pr t accepter tout brouillage radio...

Страница 23: ...den grundlegenden Anforderungen und den anderen relevanten Festlegungen der Richtlinie 2014 53 EG Wien Greek Welch Allyn WLAN device 2014 53 Hungarian Alul rott Welch Allyn nyilatkozom hogy a WLAN dev...

Страница 24: ...ETIC COMPATIBILITY EMC Page 22 Swedish H rmed intygar Welch Allyn att denna WLAN device st r I verensst mmelse med de v sentliga egenskapskrav och vriga relevanta best mmelser som framg r av direktiv...

Страница 25: ...ing resting ECG s The RScribe is a 12 channel diagnostic electrocardiograph intended for recording and printing ECG s of adult and pediatric patients The acquired ECG will be displayed for quality che...

Страница 26: ...an with a silent second opinion through diagnostic statements displayed on the ECG report For additional information on the VERITAS algorithm please refer to the Physician s Guide to VERITAS with Adul...

Страница 27: ...000 Hz ECG acquisition and is operated by two buttons located on the front of the device when used with RScribe 1 Power On Off 2 Acquiring a 12 lead ECG NOTE Rhythm button is non functional for use wi...

Страница 28: ...ond audio on then device turns off WAM has detected a very low battery status and powered off AM12 with Lead Wires Figure 2 AM12 with Lead Wires Replaceable Lead Wires LED Indicators 12 Lead ECG butto...

Страница 29: ...re to be installed and double click on the Setup application file If asked allow the program to make changes to the computer by clicking Yes The Exam setup window will appear prompting you to install...

Страница 30: ...erver Configuration window displays the default Database Port number 5432 and an option to enable or disable the Unique Patient option Database Port It is recommended that you use the default port num...

Страница 31: ...ngs Select Next to return to the Server Configuration window to continue the installation steps Select Cancel to exit the installation process Select Next and the Installation window below will appear...

Страница 32: ...ly intended for Server systems Normally when an exam is active selected all data will be copied from the system database to the local client workstation If a path is entered here the temporary data wi...

Страница 33: ...ick Yes when prompted to allow changes to the computer Once your system serial number is entered this utility generates the site code that is needed for activation by Welch Allyn Technical Support per...

Страница 34: ...he icons in the center of the screen indicate workflow tasks in presumed order left to right Click the icon representing workflow task you wish to perform Hover the mouse over an icon to display its f...

Страница 35: ...Entry and proceed directly to real time ECG for immediate acquisition Start a Resting Exam Use to enter exam data and begin real time ECG acquisition Exam Search Use to search for exams in the databa...

Страница 36: ...xisting patient export service logs Scheduling and order entry is only available when RScribe is not linked to an external scheduling system Patient Hookup Start a Resting Exam Ability to start a test...

Страница 37: ...tabase server Network Infrastructure 100 Mbps connection or better required for use with server Printing Device HP M501dn Windows printer with HPUPD PCL 5 driver or equivalent Optional Function Welch...

Страница 38: ...etwork 100 Mbps connection or better Input Devices Standard keyboard and mouse Specifications subject to change without notice Requirements for RScribe as a Citrix XenApp Requirements Client Machines...

Страница 39: ...samples second channel acquisition 1 000 samples second channel transmitted for analysis Resolution 1 875 microvolt LSB User Interface Two button operation ON OFF and 12 lead ECG acquisition Rhythm b...

Страница 40: ...r sertifikat yang diterbitkan untuk setiap alat dan perangkat telekomunikasi b 8260 WAM adalah nomor PLG ID identitas pelanggan berdasarkan database Lembaga Sertifikasi a 58975 SDPPI 2018 UTK is a num...

Страница 41: ...National Telecommunications Commission WAM ESD 18 18399C UTK ESD 19 19449C Singapore Info Communications Media Development Authority IMDA South Korea Korea Communications Commission KCC Certification...

Страница 42: ...our dealer or go to www welchallyn com for more information Part Number Description 9293 046 07 COMBINER WAM LEADS 10 POS GRAY 9293 046 60 LEAD SET WAM 10 WIRE BANANA AHA GRAY 9293 046 61 LEAD SET WAM...

Страница 43: ...se to review any completed exam s full disclosure data This includes the ability to edit measurements sign print and export the final report from multiple RScribe workstations and review stations on y...

Страница 44: ...ing the RScribe database folder normally C ProgramData MiPgSqlData from the folders to be scanned If a technical support issue is reported you may be asked to remove the virus scanning software to all...

Страница 45: ...phic data entry The patient is connected to the RScribe through the data acquisition module data is collected and one or more 10 second ECGs are saved for analysis and further processing Patient Infor...

Страница 46: ...ST 10 captures the most recently acquired 10 second ECG Or select the ECG button on the WAM or the AM12 that will capture either the BEST or LAST 10 seconds of acquired ECG dependent on RScribe config...

Страница 47: ...the number of ECGs captured is displayed in the lower right corner of the display ECGs are automatically captured according to the Full Disclosure duration defined by the administrator ECG capture au...

Страница 48: ...n the PC The WAM is synchronized with the UTK making them a matched pair Using the same UTK and WAM that were last paired maintains their synchronization Pairing WAM with RScribe Start the RScribe app...

Страница 49: ...l be used to search through the Modality Worklist MWL to display orders that start with matching text in the Last Name First Name or Patient ID A blank search field will list all orders MWL columns in...

Страница 50: ...the order without saving When entering an order use the Group drop down list to assign the order to a specific group that has been configured in the system settings This is not necessary when there is...

Страница 51: ...d only demographics without saving changes New Patient A New Patient button clears any selected patient information allowing addition of a new patient in the list The new patient information can be en...

Страница 52: ...as 2 x 2 or 4 x 4 gauze to remove residue from cleaning dead skin cells and oil and to increase capillary blood flow NOTE With elderly or frail patients take care to not abrade the skin causing disco...

Страница 53: ...low it is the 2nd intercostal space Palpate and count down on the chest until you locate the 4th intercostal space Patient Hookup Summary Table AAMI Lead IEC Lead Electrode Position Red Red On the 4th...

Страница 54: ...display Skip to ECG Acquisition and Storage on the following pages Patient demographics may be entered during ECG collection or after ending ECG acquisition by retrieval of the STAT ECG from the datab...

Страница 55: ...on the calendar icon Select the decade and the year use the left right arrows to scroll the year the month and the day to populate the field Age will be automatically calculated RScribe will remember...

Страница 56: ...Pairing menus o Select ECG Timed Capture to automatically acquire ECGs at preset time intervals Refer to page 39 for instructions o Select WAM Pairing to pair the WAM acquisition module Refer to page...

Страница 57: ...aphics Only height weight admission ID medications notes referring physician and location can be edited ECG button permits the capture of an ECG at any time the patient is connected 10 appears in the...

Страница 58: ...sed for lead fault Check the electrode connections for any misplacement NOTE Although the majority of lead wire swaps are correctly detected some real ECG configurations may give rise to an inappropri...

Страница 59: ...a on the screen refreshes additional ECGs can be acquired as necessary Previously acquired data will be retained in the buffer until the full disclosure buffer has been filled See the description of t...

Страница 60: ...and global values An undo icon in the bottom right corner of the measurements area can be selected to revert back to the original measurements when selected before saving the ECG NOTE If no patient ag...

Страница 61: ...permission to review the RScribe program will automatically restart in Review mode after ending the ECG acquisition session with the first ECG captured in the session selected When multiple timed ECGs...

Страница 62: ...ls like measurement calipers NOTE Changes are maintained ONLY for the current sessions Settings will revert back to the default settings with the next exam Refer to the System Settings section in this...

Страница 63: ...ead format Right mouse click while the cursor is over the ECG waveform in the Full Disclosure window Select Waveforms Select Single Lead Format Select from I II III aVR aVL aVF V1 V2 V3 V4 V5 or V6 Fu...

Страница 64: ...fast notches For pediatric ECGs a 300 Hz setting is recommended Filter settings apply only to displayed and printed data Data is stored in unfiltered format NOTE The High Pass filter or base line fil...

Страница 65: ...Last 10 NOTE Defines whether or not the RScribe will automatically capture the 10 seconds ECG with the lowest noise level from the full disclosure buffer or the last 10 seconds of data when the ECG bu...

Страница 66: ...terpretive statements selected by the analysis program For Example Anteroseptal Infarct 40 ms Q WAVE IN V1 V4 where Anteroseptal Infarct is the interpretive statement and 40 ms Q WAVE IN V1 V4 is the...

Страница 67: ...ked Listed exams can be sorted by clicking any of the column headers When a complete last name first name or patient ID is entered in the search field and the Search button is clicked all matching exa...

Страница 68: ...r permissions Unavailable buttons will appear grayed Advanced Search For more sophisticated exam list filtering click on the Advanced button The identifier selections are relational to the selected fi...

Страница 69: ...statements the ECG can be saved marked as reviewed or signed After selection of any of these icon buttons the user is returned to the Exam Review list Patient ID Sign Review Save Print ECG Editing Me...

Страница 70: ...caliper tool A caliper tool is available in the context menus when you right click anywhere in the main ECG window and select Show Calipers Calipers for amplitude and duration measurements will appea...

Страница 71: ...will be printed Complete the Editing process Select Save to complete the editing process and return to the Exam Review list o ECG is saved with an acquired status if not previously marked as reviewed...

Страница 72: ...o toggle the ECG grid background on or off An X appears when the background is off Sections Use the checkboxes at the left of the display to choose sections for inclusion or exclusion in the final rep...

Страница 73: ...gure ELI Link for DICOM connectivity XML and PDF file exchange Configure workflow Unlock exams Configure patient demographics fields Manage User Accounts and Personnel User s Database The IT administr...

Страница 74: ...anage Create Groups Groups allow the IT administrator to group exams according to user access reporting preferences modality settings and file exchange preferences Any user can be assigned to multiple...

Страница 75: ...ality Settings define all RScribe modality specific default values that do not change on a daily or patient to patient basis Most of these settings can be modified within the RScribe modality for a si...

Страница 76: ...nd prints at the bottom of the ECG Anti aliasing To apply anti aliasing to ECG view Select Anti aliasing Choices On Off NOTE Anti aliasing reduces slightly the staircase effect due to individual pixel...

Страница 77: ...AC Filter To change default ECG AC filter Select AC Filter Select from None 50 Hz or 60 Hz NOTE RScribe removes 60 Hz or 50 Hz interference The setting you select depends on the line frequency in you...

Страница 78: ...y capture the 10 second ECG with the lowest noise level from the full disclosure buffer or the last 10 seconds of data when the ECG button is selected Auto Capture Time mm ss Set from a minimum of 20...

Страница 79: ...buffer Single lead by 6 displays six lines of ECG data in the full disclosure buffer Three lead displays two groups of three leads in the full disclosure buffer The amount of data displayed is depende...

Страница 80: ...t the lead printed on full disclosure printouts Buffer Size Select Buffer Size Choices 5 10 20 30 45 60 minutes NOTE Use the Buffer Size to select the total amount of acquisition time permitted in the...

Страница 81: ...lect 3 1 Lead Format Choices I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 3 3 Lead Format Lead Select 3 3 Lead Format Choices I II III aVR aVL aVF V1 V2 V3 V4 V5 V6 NOTE 3 3 lead format requires a lead sele...

Страница 82: ...Select Print Interpretation Choices On Off Reasons Text Select Reasons Text Choices On Off NOTE Reasons statements indicate why a particular interpretive statement was printed Reasons statements print...

Страница 83: ...iscard Changes button to cancel any changes The Long format contains all available demographics The Custom format has been created through use of the ELI Link tool Refer to the ELI Link administrator...

Страница 84: ...enable communication and enter appropriate information into the available fields The following table describes the available ELI Link configuration settings Item Description Host Name or IP Entry fie...

Страница 85: ...orage System Add Archive Location Select New Archive button to define a path to the archive directory destination Any external disk e g NAS USB etc accessible from the RScribe central database is a ca...

Страница 86: ...ow exams that contain the characters To search by Archive Label the first letter of the label can be entered with the Start With description or the entire Archive Label can be entered with the Equal T...

Страница 87: ...fore and after changes A legend with colored highlighting will point to added removed changed and moved information All configuration information user information patient demographic information exam...

Страница 88: ...authorized user No further workflow processing is required Workflow Config A Legal Signature can be enabled by selecting Yes or disabled by selecting No When legal signature is set to Yes the user is...

Страница 89: ...o RScribe Set selections can be changed when the user selects the Advanced search selections The user can also change the password in this window when the system is not set up with a single sign on Al...

Страница 90: ...will open a dialog window prompting a Group choice from a drop down list Each group that has been defined will have its own report configuration Select the group Choose the Resting report from the top...

Страница 91: ...ly Yes Service Logs only Exam Search Edit No No No No Yes Acquired and Edited Exams only Report No No No No No Copy Offline No Yes No No No Open Offline No No No No Yes Export No No No No No Reconcile...

Страница 92: ...ed Exams only No Yes Report No No No No Yes Reviewed and Signed Exams only Copy Offline No No No No No Open Offline Yes Yes Yes No Yes Export No No No Yes Reviewed and Signed Exams only No Reconcile Y...

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