OPERATION / SERVICE MANUAL
Contents
1. 601 1 21 EZE Go To Table Of Contents ka IQmark Digital Holter Recorder Operation Manual VIII Reordering Supplies Contact your local distributor for reordering supplies for your Holter monitoring Midmark Part Number Description 1 370 0002 CompactFlash card 2 100 0080 Prep Kit lQmark Holter 5 lead 2AA s each 2 100 0081 Prep Kit lQmark Holter 5 lead 2AA s case 30 kits Prep Kit IQmark Holter 7 lead 2AA s each Prep Kit lQmark Holter 7 lead 2AA s case 30 kits 22 Go To Table Of Contents Midmark Diagnostics Group 1125 W 190 Street Gardena California 90248 Support Services 1 800 624 8950 Option 2 MIDMARI lt www midmark com Midmark Corporation 2009 Because we care2. Holter Recorder prior to use 2 Disconnect the recorder from patients during defibrillation 3 The recorder is not designed for sterile use 4 The recorder is not intended for use with rechargeable batteries 5 Instrument maintenance e Keep the recorder away from splashing water e Do not store or use the recorder where humidity ventilation direct sunlight or air containing dust salt or sulfur might affect it e Prevent the recorder from slipping and protect it from the possibility of vibration shock or drop be particularly careful during transport e Do not store or use the recorder in a chemical storage area or where gas is generated 6 Preparation of the recorder prior to operation e Verify proper recorder operation e Check that cable connections are secure 7 Precautions while using the recorder e Avoid activities that could affect the quality of recorded signals Do not sleep under an electric blanket e Patients should not shower take baths use hot tubs or perform similar activities while wearing the recorder e Keep the recorder and electrode sites dry while in use e Donot tamper with the recorder Do not remove the flashcard or battery until the recording is complete 8 Precautions after using the recorder e Remove the batteries and flashcard e Download patient data to computer as soon as possible to preserve patient data e Do not remove then reinstall batteries with the flashcard installed Patient data will be
3. touching the electrode sites e Do not to use an electric blanket while using the recorder e Avoid environments that have strong electrical or electromagnetic interference See Section VI EMC Requirements for the IQmark Digital Holter Recorder 9 Place the recorder into the pouch and secure the pouch to the patient s belt via use the belt provided or through the loop on the back of the pouch 10 J Next Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual D Early Termination of Recording The recorder automatically terminates each recording after 24 hours To terminate the recording sooner remove the battery and flashcard A loss of up to six 6 minutes of data is normal if the recording is terminated early 4 CAUTION Removal of the flashcard during the first ten 10 minutes of recording will result in a flashcard with no data stored on it 11 J Next Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual IV Troubleshooting Guide This Troubleshooting Guide provides a list of solutions and recommendations to potential problems you may encounter while using the IQmark Digital Holter Recorder Before calling Midmark Customer Service please refer to the following table for help Error Message Problem No tone or display following initial battery installation LCD displays FLASHCARD NOT INSERTED and the unit emits a continuous tone following ba
4. CG Recording e 7 lead Holter recordings Utilize a bipolar lead system where there is one positive and one negative lead for each channel plus a recorder ground e 5 lead Holter recordings Utilize a bipolar lead system that shares either positive or negative leads between the channels and a recorder ground Five Lead Wire Configuration Lead Color Placement Channel 1 Channel 2 Place at center of manubrium and top of sternum White Channel 3 Me Place on the right side below the V1 or V3R position at the bottom of the rib cage Brown Channel 1 Place on the left side on a rib at the V3 position Black Channel 2 Channel 3 Place on the left side at the V5 position on a rib Green Ground ee biner nig side ont vs posiin e VSR RED BROWN CHANNEL 1 RED BLACK CHANNEL 2 WHITE BLACK CHANNEL 3 RE CHANNEL 1 2 BROWN CHANNEL WHITE CHANNEL 3 BLACK GREEN CHANNEL GROUND 2 3 Figure 2 2 Typical three channel five lead electrode placement configuration Go To Table Of Contents ka IQmark Digital Holter Recorder Operation Manual Seven Lead Wire Configuration Lead Color Placement White Channel 1 Place at top of sternum Channel 1 Place on the left side at the V3 position on a rib Black Channel 2 Place at top of sternum adjacent to white lead Brown Channel 2 SO Pleo tsdeattevs poston onare Blue Channel 3 n e Orange Channel 3 OOS
5. Fico emadest va orvan poson onare Green Ground Place on the right side opposite Vs position i e V5R NOTE WHITE RED CHANNEL 1 BLACK BROWN CHANNEL 2 BLUE ORANGE CHANNEL 3 RANGE CHANNEL 3 GROUND CHANNEL 2 Figure 2 3 Typical three channel seven lead electrode placement configuration Go To Table Of Contents J Next IQmark Digital Holter Recorder Operation Manual III Recorder Operation A Required Materials e One 1 Delkin or one 1 Sandisk CompactFlash memory card 64MB 1GB e Midmark Holter Patient Preparation Kit e Qmark Digital Holter Recorder e Patient cable e Carrying case and belt B Recorder Set Up and Configuration Patient Cable 1 Remove the color coded patient cable from the shipping package 2 Attach cable to the patient cable connector on the recorder a Ensure proper alignment of the connector before tightening the cable to the recorder b Do not over tighten Patient Patient Event Button Cable Connector in sai 434 m peas AG LCD ATE Liquid Crystal Display S 49 M n om lOma rk Seb rend Sees lee Co Digita Holter Racordar do HERE e se Th Flash Slide To Compartment Battery OPEN Door Pree FRONT BACK Figure 3 1 Qmark Digital Holter RecorderCF components Recorder input configuration is automatically selected by the attachment of the appropriate patient cable The options are 5 lead 3 channel or 7 le
6. Go To Table Of Contents OPERATION SERVICE MANUAL lQmark Digital Holter Recorder ALT VA VAN Ge Ge Part Number 3 100 1045 Revision G J Next IQmark Digital Holter Recorder Operation Manual Table of Contents A WORD OF THANKS aan aensmeuneteasmrsenesnannins Il PRECAUTIONS serennu e TTI EE a HI I GENERAL INFORMATION ara 1 O PRO A AE ot pocorn E E EA EA E 1 A Key COMPOMGING s cxcarecapacenonntateercaniawacecapanstesessantaatpecstaressananecstareiess tia E A A 2 Fanen vent BUNTON pinoia ep ina EE ENEA EAE E EAE 2 SOM ia 2 B SYSECNISPECTECALONS arnie ici rara roi 3 Il PATENT PREPARATION iaia 4 A REGIS VACUA CARRO RR RR ATE 4 B Electrode SITS Preparation isndacconsannsindansdnocnowasarettne copsunencbanataeasanttaweieseaerausndedpeadasedaetanendswarraanareateas 4 C ThRreeicnanneFECG Recordi tania 6 Five Lead Wire Configuration iii 6 Seven Leda Wire ONdUrdioliariaialmaa 7 III RECORDER OPERATION clear 8 A Redam en Meral ra A AIA 8 B Recorder Set Up and Configuration 8 P O E EE EEEE EON EEE A E E ira 8 CompactFlash Card Insertion and Removal iii 9 Remove the flashcard by depressing the ejector button rie ieieiieei 9 C Starting a RECON GING izle 9 EofiyTerminsUonoFReCordi tai 11 IV TROUBLESHOOTING GUIDE 12 V MAINTENANCE AND STORAGE ssessssecscscecscscscecscscscscscecscscscececececececscscecece
7. R STACKED WITH OTHER EQUIPMENT IF ADJACENT OR STACKED USE IS NECESSARY THE IQMARK DIGITAL HOLTER RECORDER SHOULD BE OBSERVED TO VERIFY NORMAL OPERATION IN THE CONFIGURATION IN WHICH IT WILL BE USED Guidance and manufacturer s declaration electromagnetic emissions The IQmark Digital Holter Recorder is intended for use in the electromagnetic environment specified below The customer or the user of the Qmark Digital Holter Recorder should assure that it is used in such an environment inni Compliance Electromagnetic environment guidance RF emissions Group 1 CISPR11 The lQmark Digital Holter Recorder uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B CISPR11 Harmonic emissions CISPR11 The lQmark Digital Holter Recorder is suitable for use in all establishments including domestic establishments and those Voltage fluctuations N A directly connected to the public low voltage power supply flicker emissions network that supplies buildings used for domestic purposes IEC 61000 3 3 15 Guidance and manufacturer s declaration electromagnetic immunity Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual The IQmark Digital Holter Recorder is intended for use in the electromagnetic environment specified below The customer or the user of the Qma
8. ad 3 channel Please see Figures 2 2 and 2 3 for proper cable selection Go To Table Of Contents J Next IQmark Digital Holter Recorder Operation Manual CompactFlash Card Insertion and Removal The flashcard access port is located in the battery compartment When the flashcard is fully inserted the ejector button will fully extend Remove the flashcard by depressing the ejector button i eign 4 a depressed odg aie ee ied a mmi Flashcard Ejector Button extended Figure 3 2 IQmark Digital Holter RecorderCF CompactFlash Card insertion removal C Starting a Recording 1 Prepare the patient as described in Section II Patient Preparation 2 Inspect patient cable for signs of wear Ensure the patient cable is properly connected to the patient input connector on the recorder 3 Insert the flashcard see Section B CompactFlash Card Insertion and Removal X CAUTION All previously recorded ECG data stored on the flashcard will be erased once the new battery is installed 4 Install new alkaline AA batteries NOTE The recorder emits a continual tone and the LCD displays FLASHCARD NOT INSERTED if the flashcard is inserted improperly A NOTE The recorder sounds warning beeps and displays LOW BATTERY if the power level is low Replace the batteries immediately Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual Recorder should beep once a
9. ark Digital Holter Recorder Operation Manual VI EMC Requirements for the lQmark Digital Holter Recorder Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Addendum Portable and mobile RF communications equipment can affect the operation of medical electrical equipment The lQmark Digital Holter Recorder is medical electrical equipment The following is a list of the lead wires and CompactFlash cards that are used as part of the IQmark Digital Holter Recorder that comply with sections 36 201 and 36 202 of the EMC Standard IEC60601 1 2 E Electromagnetic compatibility testing has not been conducted using lead wires longer than 40 inches 101 6 cm Lead Wires 5 Lead 3 Channel Lead Wires 7 Lead 3 Channel Lead Wires Memory Cards SanDisk CompactFlash card standard length Type CompactFlash cards conforming to CompactFlash Specification 1 4 as issued by the CompactFlash Association Use of lead wires CompactFlash cards or accessories other than those specified with the exception of lead wires CompactFlash cards and accessories sold by the manufacturer of the Qmark Digital Holter Recorder as replacement parts for internal components may result in increased EMISSIONS or decreased IMMUNITY of the lQmark Digital Holter Recorder VA CAUTION THE IQMARK DIGITAL HOLTER RECORDER SHOULD NOT BE USED ADJACENT TO O
10. cececesecesesesee 13 A Preventative ISD OCTION successors daeasinatianandeadatenasaudisdnadaeadcaelamendonsbacaasastandauatannsadasdeadsiandedsedenddwaieats 13 B Cleaning the Recorder rea 13 CENNO NEON nia 13 Cleaning the PAC 13 C Bad Weather eli NEOR RE 14 D EIEEE S AE E NE T P E E S T A ew gene eae E E A A E E 14 E Radio and Television Interference i 14 VI EMC REQUIREMENTS FOR THE IQMARK DIGITAL HOLTER RECORDER 15 VIE SERVICE AND SUPPOR T siscsssasscsavsenscesoveswedawsetawaaeaansouavsousdenouansodiwseGivesesaedesawsenaeasedaavelawsesisestaveees 19 A Technical SUDDO E gni 19 B VATE EE E E E O E O 20 Return Materials Authorization RMA ssscccccscccsseseecccecscccnesseecssccceeuseecesessuanunseeeessssauueeeeessssauenseeeeeeeees 20 Via rie 20 CL Safety and International SymMbolS 21 VIII REORDERING SUPPLIES siccseviccsincavaawaiivestexdesscasedavaavsuccoweusedeueetevseeseuseuaveamsscenreavesavesteudseaenens 22 J Next Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual A Word of Thanks Thank you for your purchase of the IQmark Digital Holter Recorder Midmark has used the latest microelectronic and computer software technology to develop a fast efficient and accurate digital Holter system We believe you will be pleased with the user friendly operation of our product and its results As your partner in healthcare we l
11. er It is ultimately the responsibility of the customer when shipping a product to ensure that all packages and their contents arrive at Midmark safely MIDMARK WILL NOT ASSUME RESPONSIBILITY FOR DAMAGE INCURRED BY IMPROPER PACKAGING SHIPMENT OR PRODUCT USE SUCH ACTIONS VOID ALL APPLICABLE WARRANTIES Midmark Diagnostics Group 1125 West 190 Street Gardena CA 90248 Tel 310 516 6050 USA 800 624 8950 ext 2 Fax 310 516 6517 20 J Next Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual C Safety and International Symbols The following symbols are used on the IQmark Digital Holter Recorder product Refer to this directory for details concerning symbols used on the instrument Alkaline ec I HTOIIl g I 3 3V ATTENTION Refer to manual for instructions Year of manufacture Battery Orientation This device uses 2 AA alkaline batteries The icon indicates the proper orientation of batteries to be installed DC Voltage This device uses 3 Volt DC power and consumes 20mA nominal when in use CE Mark Equipment displaying this symbol has passed specific safety tests and adheres to international quality standards established by the European Commission Device is compliant with IEC 60601 1 as a Type BF internally powered device Ordinary enclosure IPXO Keep the instrument away from splashing water Conforms to UL Std 2601 1 and Certified to CAN CSA Std C22 2 No
12. er than an intercostal space 3 Shave electrode placement areas as needed EZE Go To Table Of Contents ka IQmark Digital Holter Recorder Operation Manual 4 Gently scrub the skin with an abrasive pad lint free gauze pad or fine Sandpaper enclosed in the preparation kit This loosens and removes dead skin 5 Wipe the scrubbed area with a clean alcohol pad and ensure the entire electrode site is free of oil Repeat for all sites Allow these areas to air dry naturally before attaching electrodes 6 Follow the electrode manufacturer s application instructions when applying snap leads to the electrodes To simplify this process first apply the lead wire snaps to the electrodes then apply the electrodes to the patient 7 Remove the backing from a pre gelled disposable electrode and place an electrode on each of the prepared electrode sites make certain that the right colored lead is placed on the proper site Ensure that the gel in the center of each electrode maintains contact with the prepared skin surface and the electrode is not wrinkled 8 Forma stress loop with each electrode lead then tape the loop to the skin This reduces artifacts caused by snap rotation when leads are pulled or tugged by normal patient movements Electrodes a Tape I Stress loops Figure 2 1 Examples of stress loops Go To Table Of Contents ka IQmark Digital Holter Recorder Operation Manual C Three Channel E
13. he maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum output power of 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz transmitter d 1 2 VP d 2 3 VP 35 5 d 7 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 18 Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual VII Service and Support The IQmark Digital Holter Recorder does not contain user serviceable components Please return to Midmark for servicing Figure 7 1 Expanded View of IQmark Digital Holter Recorder Legend Dl Top cover O E Bottom cover 05 RR mess Battery cover 01 POR E ORA Battery clips 4 Db ela Patient connector bulkhead 07 RR RETTA Liquid crystal display LCD OF PERE E Re Printed circuit board PCB Lila CompactFlash card A Technical Support For questions pertaining to this p
14. ient Preparation Kit contains e 5 or 7 silver chloride disposable electrodes designed for 24 hour Holter monitoring e Abrasive pad Patient diary Isopropyl alcohol wipes e Razor Two 2 AA alkaline batteries NOTE Do not use 12 lead resting ECG or stress test electrodes We recommend using the Midmark Holter Patient Preparation Kit for consistent quality ECG data B Electrode Site Preparation Careful preparation of the patient s electrode sites is essential for obtaining an interference free ECG and accurate result especially in Holter monitoring The skin is naturally a poor conductor of electricity and frequently creates artifact that distorts the ECG signal due to dry or dead epidermal cells oils sweat and dirt By performing methodical skin preparation you greatly reduce the resistive barrier that causes muscle noise and baseline wander ensuring high quality signal and test data 4 CAUTION Poor site preparation improper electrode placement or use of inferior electrodes may lead to unusable data or an inaccurate analysis The following steps are very important in obtaining usable ECG data 1 Select the electrode placement configuration from a reliable clinical reference source Two typical configurations are illustrated in Figures 2 2 and 2 3 2 Select electrode sites located over bony areas where reduced tissue movement will minimize the amount of signal artifact Electrode sites should be over a rib rath
15. is located in the battery compartment EZE Go To Table Of Contents ka IQmark Digital Holter Recorder Operation Manual B System Specifications IQmark Digital Holter Recorder Performance Specifications Category Specification Intended Use Provides 24 hour Holter recordings which permit the detection of abnormalities in the transmission of cardiac impulses through the heart muscle serves as an important aid in the diagnosis of heart ailments PHYSICAL 4 ounces 4 46 x 2 75 x 1 02 inches 113 x 70 x 26 mm O to 60 degrees Celsius 1 Meter drop Weight Dimensions Operating Temperature Non Operating Shock Operating Position Any orientation Humidity 10 to 95 non condensing Storage Media IDE PCMCIA CompactFlash card Standard FUNCTIONAL 24 hours Recording Time Channels gt 00 W o wn Sample Rate 28 samples per channel sec Resolution Bandwidth Input range 0 05 to 60Hz 3dB 5 0 mV 2 AA IEC LR6 5 or 7 lead configuration 60 dB PACE DETECTION SPECIFICATION Serial Number 380000 or higher 2 mV to 500 mV 2ms to 0 1ms Battery alkaline Patient Input CMRR Pulse Amplitude at skin Pulse Width at skin Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual II Patient Preparation A Required Materials Operators must have a Midmark Holter Patient Preparation Kit or a similar high quality Holter preparation kit The Midmark Holter Pat
16. ital Holter Recorder Operation Manual NOTE Worn or damaged patient cables are the most common cause of poor quality recordings Successive poor ECG tracings may indicate the patient cable needs to be replaced C Bad Weather Conditions In rain or snow conditions instruct patients to protect the recorder from the elements by wearing the recorder inside a coat D Storage To prevent damage to the recorder due to battery leakage or oxidation the batteries should be removed whenever the recorder is not in use or prior to storage for a long period of time Avoid extreme humidity and heat during storage Although the flashcard is very durable it should be stored within the recorder or its original case when not in use This reduces the possibility of dust or moisture damaging the flashcard E Radio and Television Interference This equipment generates and uses radio frequency energy If not installed and used properly in strict accordance with the manufacturer s instructions it may cause interference with radio and television reception This equipment has been tested and proven to be in compliance with standards for medical devices in accordance with the IEC 601 1 rules which are designed to provide reasonable protection against such interference in a medical or hospital environment See Section VI EMC Requirements for the Qmark Digital Holter Recorder for requirements when operating the recorder 14 J Next IQm
17. lost e Keep the recorder clean to ensure trouble free operation during next use 9 Perform routine inspection of the recorder and accessories 10 Do not make any modifications to the recorder DANGER Possible explosion hazard if used in the presence of flammable anesthetics Z4CAUTION Refer servicing to qualified service personnel J Next Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual I General Information Figure 1 1 The IQmark Digital Holter Recorder Description The IQmark Digital Holter Recorder is a lightweight compact digital Holter recorder designed for reliability and ease of use in ambulatory ECG applications Because the digital design has no moving parts the Qmark Digital Holter Recorder records cleaner ECG quality and has lower maintenance cost when compared to tape based Holter recorders A liquid crystal display LCD assists Holter technicians in the verification of proper patient hookup eliminating the need for expensive test cable interfaces with EKG machines The IQmark Digital Holter Recorder can be configured as a 7 lead 3 channel or 5 lead 3 channel recorder by changing the patient cable Data is conveniently stored on a reusable flashcard eliminating the need for cassette tapes Digital technology also eliminates tape based variables such as tape head frequency speed variations distortion and tape brand inconsistencies The removal of these
18. nd the LCD will activate If not verify if e The above sequence was followed e The batteries were correctly installed e The recorder is operating properly To verify connection the recorder displays the three channels of the patient s ECG on the LCD readout Press the event button to display an enlarged single channel display or to rotate through the channels All 1 2 3 The recorder will automatically start recording in approximately eight 8 minutes If you need more time to complete or correct the patient connection remove one of the batteries and replace it when you are ready to continue NOTE After a good connection has been verified the ECG recording mode may be started immediately by pressing and holding the event button for five seconds or until the ECG display turns off Document the recording start time in the patient diary preferably using the patient s watch for the correct time Otherwise use your own watch or a wall clock NOTE The recorder will always report a start time of 00 00 00 The Holter scanning technician uses the start time that is entered in the diary as the start time for the recording Before the patient is released verify that s he understands the following e How to use the event button and patient diary see Section A Patient Event Button for more information e Keep the recorder away from moisture e Do not tamper with the recorder or remove the flashcard or batteries e Avoid
19. ook forward to working with you in the coming years as we develop even more sophisticated diagnostic technology for the cardiopulmonary field Your thoughts questions and comments about our product are welcome YACAUTION Federal Law restricts this device to sale by or on the order of a physician Physician s Responsibility The results provided by IQmark Digital Holter Recorder are for the exclusive use of licensed physicians or personnel under their direct supervision It is the responsibility of the physician to ensure proper administration of the test making a diagnosis obtaining expert opinions on the results and instituting the correct treatment Disclosures The information in this guide is subject to change without notice Midmark shall not be liable for technical or editorial omissions made herein nor for incidental or consequential damages resulting from the furnishing performance or use of this guide This document may contain proprietary information protected by copyright No part of this document may be photocopied or reproduced in any form without prior written consent from Midmark Qmark is a registered trademark of Midmark J Next Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual 4Precautions Read the following to ensure the proper operation of the Qmark Digital Holter Recorder 1 Familiarize yourself thoroughly with the operational procedures of the IQmark Digital
20. or use in the electromagnetic environment specified below The customer or the user of the Qmark Digital Holter Recorder should assure that it is used in such an environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Qmark Digital Holter Recorder including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms Recommended separation distance IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m Not Applicable d 1 2 VP 80 MHz to 800 MHz IEC 6100 4 3 80 MHz to 2 5 GHz d 2 3 VP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol of equipment marked with the following symbol Ko NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field
21. rk Digital Holter Recorder should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 NOTE Ur is the a c mains voltage prior to application of the test level IEC 60601 test level 6 kV contact 6 kV contact 8 KV air 8 KV air 2 kV for power supply lines 1 kV for input output lines 1 kV for differential mode 2 kV common mode lt 5 Ur gt 95 dip in Ut for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in U7 for 25 cycles lt 5 U gt 95 dip in Ur for 5 sec Compliance level Electromagnetic environment guidance Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Battery powered device Battery powered device Battery powered device Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment 16 J Next IQmark Digital Holter Recorder Operation Manual Guidance and manufacturer s declaration electromagnetic immunity The IQmark Digital Holter Recorder is intended f
22. roduct and technical support consult this manual the Troubleshooting Guide or contact Midmark Support Services at 800 624 8950 ext 2 between 6 30 AM to 4 30 PM Pacific Standard Time 19 EZE Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual B Limited Warranty AII Midmark digital module products are warranted to be free from manufacturing and material defects for 12 months from the date of purchase CompactFlash cards are warranted for 90 days and Holter patient cables are warranted for 30 days Any misuse or abuse of a Midmark product voids all applicable warranties A full copy of the Midmark limited warranty is found on the warranty registration documentation provided with this product Return Materials Authorization RMA To return any product for any reason a Return Materials Authorization RMA number must be obtained from a Midmark Support Services representative The number must be referenced on the package s containing the items to be returned and in any correspondence regarding the return Shipping Before shipping any unit to Midmark be certain that an RMA number has been issued and that all guidelines regarding this authorization are followed We highly recommend that you follow all guidelines for the shipment of medical products set forth by your shipping company If you have a question regarding the appropriate shipment method please feel free to ask when calling for your RMA numb
23. strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the IQmark Digital Holter Recorder is used exceeds the applicable RF compliance level above the Qmark Digital Holter Recorder should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the IQmark Digital Holter Recorder gt Over the frequency range 150 kHz to 80 MHz field strengths should be less than V1 V m 17 Next IQmark Digital Holter Recorder Operation Manual Recommended separation distances between portable and mobile RF communications equipment and the IQmark Digital Holter Recorder The lQmark Digital Holter Recorder is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the IQmark Digital Holter Recorder can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the IQmark Digital Holter Recorder as recommended below according to t
24. ttery installation Unit emits a continuous two tone alarm and displays FLASHCARD DID NOT RESET Unit emits a continuous single tone beeping alarm One or more channel has low amplitude excessive artifact or a wandering baseline ECG data is not observed after recording session is complete Troubleshooting Guide Potential Solution Recommendation e Batteries are very weak e Batteries are incorrectly installed Incomplete flashcard installation 1 Remove batteries 2 Install flashcard 3 Reinstall batteries Non supported flashcard installed The flashcard did not initialize correctly reinstall batteries The flashcard did not initialize correctly reinstall batteries Bad lead wire set Poor connection Poor batteries Unit operated for less than ten minutes prior to battery or flashcard removal The flashcard or recorder has malfunctioned 12 J Next Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual V Maintenance and Storage A Preventative Inspection Perform a periodic preventative inspection prior to each use of the recorder This is done to verify there is no visible damage to the recorder that may cause it to malfunction Visual inspection should include the inspection of the Holter recorder and all cables for signs of damage and deterioration including but not limited to cracks cuts discoloration and oxidation If a cable or other accessory exhibits an
25. variables produces more accurate ST segment and RR interval readings J Next Go To Table Of Contents IQmark Digital Holter Recorder Operation Manual A Key Components Patient Patient Event Button Cable Connector m da a tn SN 500 624 8000 A G LCD onary er on ne rr i pipi Liquid taal Crystal Display CERO zz Gt Bis 580000 p IQmark ento Digital Holter Recorder F Press HERE Then BB are Flash Slide To MIDMARK Compartment OPEN emana Battery Door Pacer FRONT BACK Figure 1 2 Key components Patient Event Button A momentary Event button is provided on the recorder as a convenient means of marking and storing event times When Holter data is played back ECG events are made available that correlate to the Event button being pressed Storage Media The IQmark Digital Holter Recorder utilizes a flashcard to store ECG data The flashcard is reusable and with proper care should last for hundreds of recordings The flashcard must have a memory capacity of at least 48MB For suitable replacements or additional flashcards please contact your Midmark sales rep or Customer Service Always keep the flashcard away from moisture and inspect the pinholes for foreign matter prior to insertion When preparing for a recording session insert the flashcard before installing the battery it is not recommended to install the flashcard after the battery is installed as the access port
26. y of these symptoms replace it immediately prior to use of the recorder B Cleaning the Recorder X4 CAUTION 44 Do not use aromatic hydrocarbons rubbing alcohol or chlorinated solvents for cleaning the Holter recorder Do not use alcohol or acetone on lead wires or cables since they could stiffen and crack the insulating plastic Clean the outside of the Holter recorder with a soft cloth dampened with a mild household cleaner Avoid using excessive amounts of solution which may infiltrate the connectors battery compartments or recording module Verify that all equipment including accessories are completely dry before using 4 CAUTION Do not immerse the Holter recorder in any kind of liquid Cleaning the Carrying Case If the carrying case becomes soiled the operator has the option to purchase a new pouch or wash the existing one in cold water with a mild detergent Cleaning the Patient Cable Clean the cables following a hospital approved cleaning procedure such as those recommended by AAMI or AORN Wiping the cables with a solution of soap and water followed by a rinse with water is a simple yet effective method for cleaning the cables Do not immerse the cables in water The cables may be disinfected by wiping with a 1 10 solution of chlorine bleach and water or a 2 gluteraldehyde solution such as Cidex The cables should then be rinsed and wiped dry 13 J Next Go To Table Of Contents IQmark Dig
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