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Welch Allyn Hillrom H12+, Руководство пользователя

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Welch Allyn Hillrom H12+ Скачать руководство пользователя страница 19

 

15

 

 

ELECTROMAGNETIC COMPATIBILITY (EMC) 

 
Electromagnetic compatibility with surrounding devices should be assessed when using the device. 

 

An electronic device can either generate or receive electromagnetic interference.  Testing for 
electromagnetic compatibility (EMC) has been performed on the device according to the international 
standard for EMC for medical devices (IEC 60601-1-2).  This IEC standard has been adopted in Europe 
as the European Norm (EN 60601-1-2). 

 

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 acceptable 
manner in the configuration in which it will be used. 

 

Fixed, portable, and mobile radio frequency communications equipment can affect the performance of 
medical equipment.  See appropriate EMC table for recommended separation distances between the 
radio equipment and the device. 
 

The use of accessories and cables other than those specified by Welch Allyn may result in increased 
emissions or decreased immunity of the device. 
 
 

 

Содержание Hillrom H12+

Страница 1: ...Welch Allyn H12 12 lead Holter User Manual CAUTION Federal law restricts this device to sale by or on the order of a physician...

Страница 2: ...copyright but also reduce the ability of Welch Allyn to provide accurate and up to date information to users and operators alike Software 2019 v5 0 0 Welch Allyn H12 and HScribe are registered tradem...

Страница 3: ...ON 13 ELECTROMAGNETIC COMPATIBILITY EMC 15 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGENTIC EMISSIONS 16 GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY 16 GUIDANCE AND MANUFAC...

Страница 4: ...34 CONFIGURING THE RECORDER 35 CONFIGURATION 35 SETTING DATE AND TIME 37 SETTING LANGUAGE 37 VIEWING SOFTWARE VERSION NUMBER 37 CHANGING SAMPLE RATE HIGH FIDELITY SD CARD ONLY 38 CHANGING DURATION 38...

Страница 5: ...lch Allyn Unauthorized repairs will void the warranty In addition whether or not covered under warranty any product repair shall exclusively be performed by Welch Allyn certified service personnel If...

Страница 6: ...SERVICE AND SPARE PARTS 2...

Страница 7: ...the back of the device Care should be taken so that these numbers are not defaced Copyright and Trademark Notices This document contains information that is protected by copyright All rights are rese...

Страница 8: ...NOTICES 4...

Страница 9: ...epair by anyone not authorized by Welch Allyn and 4 accidents You assume all responsibility for the use of the Product with any accessory that does not meet the requirements described in the Product d...

Страница 10: ...WARRANTY INFORMATION 6...

Страница 11: ...for clinical applications the operator must read and understand the contents of the user manual and other accompanying documents Inadequate knowledge or training could result in increased risk of har...

Страница 12: ...uthority to operate the device A possible explosion hazard exists Do not use the device in the presence of a flammable anesthetic mixture The device has not been designed for use with high frequency H...

Страница 13: ...stored after forming them into a loose loop The device will only work with devices that are equipped with the appropriate option Do not format the SD Card using standard Microsoft Windows formatting c...

Страница 14: ...have been severely discharged No preliminary or ongoing scheduled periodic calibration by the user or Welch Allyn personnel is required The design for the device is such that the system contains no el...

Страница 15: ...could result in damage to the equipment or other property or loss of data Warning Do not use this equipment in the MRI scan room Follow instructions directions for use DFU mandatory action A copy of...

Страница 16: ...EQUIPMENT SYMBOLS AND MARKINGS 12 Global Trade Item Number Battery orientation and size Medical Device...

Страница 17: ...ning agents which may damage equipment surfaces Inspection Inspect your equipment daily prior to operation If you notice anything that requires repair contact an authorized service person to make the...

Страница 18: ...GENERAL CARE 14...

Страница 19: ...m EN 60601 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 operate...

Страница 20: ...C 61000 3 3 Not Applicable Guidance and Manufacturer s Declaration Electromagnetic Immunity The equipment is intended for use in the electromagnetic environment specified in the table below The custom...

Страница 21: ...nd 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 fre...

Страница 22: ...imum 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 4...

Страница 23: ...intended to acquire record and store ECG data of patients that have been connected to the H12 recorder and are undergoing Holter monitoring The H12 acquires digitizes and stores data to be analyzed b...

Страница 24: ...ecure digital SD card for data storage A removable standard SD card can be dedicated for use with a particular H12 recorder Along with a fresh AA battery this will provide continuous 12 lead data reco...

Страница 25: ...opposite direction of the arrow 2 until the door latches into place Inserting the Battery The H12 recorder is powered with a single AA alkaline battery Open the battery door of the H12 recorder If nee...

Страница 26: ...rough the main menu options to enter the patient ID and to set the date time and language Enter is used to select main menu and sub menu options displayed on the LCD screen and to store the patient ID...

Страница 27: ...INTRODUCTION 23 H12 Recorder in Carrying Case...

Страница 28: ...PLUS OXX XXXXX H12 High Fidelity 24 Hour SD Card 107504 H12 High Fidelity 48 Hour SD Card 107506 H12 Battery Door 413502 H12 Carrying Case with Strap and Belt 8485 020 51 LeadForm Patient Cable Domest...

Страница 29: ...0 05 to 300 Hz for high fidelity recording Digital Sampling Rate 32 000 s sec channel used for pacemaker spike detection 180 s sec channel used for standard recording and storage 1 000 s sec channel...

Страница 30: ...o 45 C Storage Temperature 40 to 70 C Operating Humidity 10 to 95 non condensing Storage Humidity 10 to 95 non condensing Operating Altitude Pressure H12 will operate normally from 700 to 1060 milliba...

Страница 31: ...ly attach each lead wire to an electrode 8 Place the gel area of the electrode over the center of the prepared area using the positioning illustrated on the next page press the adhesive ring into plac...

Страница 32: ...actors in excessive artifact prevention Limb Electrode Precordial Electrode AAMI IEC Placement AAMI IEC Placement RA R On or below the right clavicle as shown V1 C1 Fourth intercostal space at the rig...

Страница 33: ...ush down on the SD card until it is firmly engaged and can move no further To remove an SD card gently push down on the SD card to disengage and eject The internal card carrier is spring loaded Once e...

Страница 34: ...ON SETTINGS view only changes made in CONFIGURE LEAD CHECK DISPLAY ECG ENTER ID or ID if card is already prepared RECORD see Using the Recorder CONFIGURE The following operational flowchart of menu op...

Страница 35: ...m of the LCD screen Checking Impedances LEAD CHECK is a valuable tool for verifying and optimizing signal quality after patient hookup and before starting a recording From the main menu scroll to LEAD...

Страница 36: ...g Press Enter to select To enter the patient ID the cursor is moved to the desired letter or digit in the alphanumeric table and then selected by pressing Enter The cursor is initially located in the...

Страница 37: ...d fail indicator s is displayed below the Recording message and will replace the displayed patient ID number until resolved See Appendix A Troubleshooting for information on lead fail messages Enterin...

Страница 38: ...he SD card to eject and then remove the SD card Ending a Recording Session Early The recording session can be stopped at any time by performing the following steps 1 Simultaneously press and hold Up R...

Страница 39: ...at 1000 samples per second or 180 samples per second These settings are typically set before the initial patient recording and do not need to be set on a per patient recording basis From the main menu...

Страница 40: ...CONFIGURING THE RECORDER 36...

Страница 41: ...e instant you want the seconds to be reset FORMAT provides two options for the date format month day year or day month year From the DATE TIME menu scroll to FORMAT press Enter Scroll from one option...

Страница 42: ...elect and return to the SAMPLE RATE menu Scroll to DONE press Enter Changing Duration Duration is used to select recording duration in hour intervals The maximum selectable recording duration of 24 ho...

Страница 43: ...ce malfunction Disinfecting Agents for the H12 The H12 is compatible with the following disinfectants Clorox Healthcare Bleach Germicidal Wipes use according to instructions on product label or a soft...

Страница 44: ...istilledwater 8 Repeat as necessary 9 Apply disinfectant solution on affected area using a soft cloth Allow product to sit for 5 minutes 10 Wipe excess solution and clean product again with cloth damp...

Страница 45: ...e patient cables periodically depending on use and care 2 Exterior Visual Inspection Check connectors for loose bent or corroded contact points Inspect covers for warping surface damage or missing har...

Страница 46: ...MAINTENANCE 42...

Страница 47: ...Press any key to continue the powerup sequence PATINFO4 TXT error Patient information file is not properly formatted Reformat the SD card at HScribe RA RA fail Check if the lead wire is off or the ele...

Страница 48: ...TROUBLESHOOTING 44...

Страница 49: ...AY GIORNO DIA TAG DAG SET MONTH MESE MES MONAT MAAND SET YEAR ANNO A O JAHR JAAR FORMAT FORMATO FORMATO FORMAT DATANOTATIE DONE FINE OK FERTIG GEREED LANGUAGE LINGUA IDIOMA SPRACHE TAAL Recording Regi...

Страница 50: ...R DZIEN P IV DIA SET MONTH MOIS MIESIAC KUUKAUSI M S SET YEAR ANN E ROK VUOSI ANO FORMAT FORMAT FORMAT DATY P IV YS FORMATO DONE FIN ZATWIERDZ VALMIS OK LANGUAGE LANGUAGE JEZYK KIELI IDIOMA Recording...

Страница 51: ...E SET MINUTE ANGE MINUT INDSTIL MIN SET DAY ANGE DAG INDSTIL DAG SET MONTH ANGE M NAD INDSTIL MD SET YEAR ANGE R INDSTIL R FORMAT FORMATERING DATOFORMAT DONE KLAR F RDIG LANGUAGE SPR K SPROG Recording...

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