User Manual - Welch Allyn
Contents
1. Immunity Test IEC 60601 Compliance Electromagnetic Environment Guidance Test Level Level Portable and mobile RF communications equipment should be used no closer to any part of the Holter recorder including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance Conducted RF 3 Vrms 3 Vrms d 1 17 P IEC 61000 4 6 150 kHz to 80 MHz Radiated RF 3 V m 3 V m d 1 17 P 80 MHz to 800 MHz IEC 61000 4 3 80 MHz to 2 5 GHz 2 33 P 800 MHz to 2 5 GHz where Pis the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres 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 6 Note 1 At 80 MHz 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 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 the2. Caution US Federal law restricts this device to sale by or on the order of a physician The Welch Allyn Holter System is intended to be used as a Holter ambulatory electrocardiograph system for the purpose of screening for ECG rhythm disturbances over a minimum 24 hour period The Welch Allyn Holter System is intended for use under the supervision of a physician or those knowledgeable in all aspects of ECG morphology rhythm and arrhythmia This procedure is known as a Holter procedure and captures infrequent or activity provoked ECG rhythm abnormalities outside of the physician s office The Welch Allyn Holter System is comprised of the Welch Allyn Holter Recorder and the Welch Allyn Holter System Application As the patient wears the recorder component of the system it records ambulatory electrocardiograph data The Welch Allyn Holter System Application analyzes the recorder data The Welch Allyn Holter System is not intended for infants weighing less than 10 Kg The Welch Allyn Holter System acquires ambulatory ECG waveforms from patients The recorder and associated accessories provide signal acquisition for up to three channels HR100 and HR300 or up to eight channels HR1200 of patient ECG waveforms through surface electrodes adhered to the body 2 Directions for Use Welch Allyn Holter Recorder Indications for Use The Welch Allyn Holter System is intended for acquiring ambulatory ECG signals from patients Patients are people
3. e setting up configuring troubleshooting or servicing the recorder All models e Lightweight and small size provides comfort for the patient e Either of two patient activated event buttons enables patients to mark times they feel are significant Both event buttons have the same function e System status feedback LED HR 100 or LCD window HR 300 amp HR 1200 e Removable Secure Digital Memory Card for a minimum of 24 hours of ECG storage and transferring ECG data e Holter Analysis system provides real time ECG data via Bluetooth Wireless Communication to verify patient electrode placement and electronic transfer of ECG recordings e Operates on AA alkaline LR6 batteries one HR 100 or two HR 300 amp HR 1200 e Removable patient cable HR 300 amp HR 1200 e Navigational keypad enter cancel up down right and left keys e LCD window provides ECG waveform views to ensure proper electrode connection e Time of day display Directions for Use Recorder Illustrations Figure 1 HR 100 Holter Recorder Patient Activated Event Buttons Patient Cable EE C CES ugue Battery LED Compartment lt r y Sa m s Digital Card Interface Figure 2 HR 300 amp HR 1200 Holter Recorder Secure Digital SD Card Interface Batteries LCD Patient Activated Event
4. 100 2 for HR 300 amp HR 1200 Disposable Safety Razor 1 Abrading pad 1 Alcohol Prep Pads 2 Pouch 1 Patient Diary 1 Directions for Use 11 To Prepare the Patient and Place Electrodes A Caution Always ensure that the appropriate electrode placement is employed for the lead configuration selected Caution ECG electrodes can cause skin irritation Examine the skin for signs of irritation or inflammation and avoid placement of the electrode in those areas Help the patient get comfortable Patient preparation is important for a successful Holter procedure 1 2 o 5 o Describe the procedure to the patient Prepare electrode locations See Figure 4 on page 12 for 5 lead placement Figure 5 on page 13 for 7 lead placement Figure 8 on page 15 for 12 lead placement Shave the area for electrode placement if necessary Clean electrode sites with alcohol Allow electrode site to dry Attach the electrodes to the lead wires before attaching to patient Secure each lead wire Loop each lead wire into a 1 to 2 inch diameter loop position it approximately two inches from each sensor site and tape it to the skin see Figure 3 This reduces movements that cause signal artifact Figure 3 Patient Lead Wire Stress Loop Evaluating the Signal Quality from Each Lead Refer to the Holter System Application Directions for Use Clinician tasks Explain to the patient the recording procedure how to record inf
5. 100 704547 7 Lead Patient Cable IEC HR 100 704548 7 Lead Patient Cable AHA HR 300 amp HR 1200 704549 7 Lead Patient Cable IEC HR 300 amp HR 1200 704550 10 Lead Patient Cable AHA HR 1200 704551 10 Lead Patient Cable IEC HR 1200 704552 HR 100 Carrying Case and straps 704553 HR 300 amp HR 1200 Carrying Case and straps 704554 HR 100 HR 300 HR 1200 Belt Shoulder Strap 704710 Holter operator s manual on CD 704556 21 22 Directions for Use Welch Allyn Holter Recorder Electromagnetic Emissions and Immunity Information The Welch Allyn Holter Recorder is intended for use in Allyn Holter Recorder should assure that it is used in such an environment Electromagnetic Emissions the electromagnetic environment specified below The customer or user of the Welch Emissions Test Compliance Electromagnetic Environment Guidance RF emissions Group 2 The Welch Allyn Holter Recorder must emit electromagnetic energy in order to perform CISPR 11 its intended function Nearby electronic equipment may be affected RF emissions Class B The Welch Allyn Holter Recorder is suitable for use in all establishments including CISPR 11 domestic establishments The recorder has no connection to the public low voltage Harmonic emissions IEC 61000 3 2 Not applicable Voltage fluctuations licker emissions IEC 61000 3 3 Not applicable power supply network Electromagnetic Immunity The Holter r
6. 7 37 100 11 70 11 70 23 30 For transmitters rated at a maximum output power not listed above recommended separation distance d in meters can be estimated using the equation applicable to the frequency of the transmitter where Pis 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 Directions for Use 25 FCC information WARNING For patients with a pacemaker maintain a minimum of 6 inches between the recorder and pacemaker Turn the recorder off immediately and provide appropriate patient care if you suspect the recorder affected the pacemaker The Health Industry Manufacturers Association recommends a minimum 6 inch distance between a wireless radio and a pacemaker which is consistent with the recommendations of Wireless Technology Research The wireless radio is active for the first 15 minutes of the procedure only This device contains ID ED9LMX9820ASM This device complies with Part 15 of the FCC Rules Operation is subject to the following conditions e _ This device may not cause harmful interference e This device must accept any interference received including interference that may c
7. a ERES MS TORRE eee ah c du eso Ut utto E 6 Feature stenn vice t bao m pa e e DESI EM em DES 6 Recorder MlUiStraH ns een dot uA cese S enr opes Me het RN ge 7 OperatloTicz e opes Ao DE UE inu Emm te eb iiS 8 Patient Pr paration ea t dur SAW ler POSE RU 10 Holter Procedure Patient 10 Preparing for Electrode Placement on 10 x swans tur Ne ae A GEAR de MU DU Meet ET 16 Maintenance t oe Sora oett ee atte Da MR 4e e ee ALAW 17 Cleaning the Recorder and Patient 17 Inspecting the Reeorder ui E RE usn PES 17 Testirig thieBecorder eR eue P cud vx eddie reas 17 Stonn th Recorder s esten rd teles dos Ben Ehe Ao Bu DR 18 Discarding the Equipment 18 Technical SpeclfIcations c ceo e DLL pe IEEE E e HAGA 19 Conformance to Regulatory Standards 20 ACCOSSOMES nde didte sete EE dia de Ce Ma ee e edd 21 Electromagnetic Emissions and Immunity Information 22 FGGanforfations esenee Me Ee det 25 NMOUBIESHOOTING xxr c eth tr Ne tems nd et pes 26 Limited Warranty 2i bey ug GLOG O WG Fd 27 iv Contents Welch Allyn Holter Recorder Directions for Use Directions for Use Intended Use
8. and Patient Cable WARNING Keep the recorder and patient cable clean especially the components that touch patients Caution Do NOT use acetone ether freon petroleum derivatives or other solvents to clean the recorder Caution Do NOT let soap or water come into contact with the battery contacts or patient connector pins Caution DO NOT submerse autoclave or steam clean the recorder or the patient cabling Cleaning Instructions 1 2 Remove the battery or batteries and close the battery cover Wipe the Holter recorder exterior and accessories with a damp cloth Use mild detergent diluted in water Dry with a clean soft cloth or paper towel Reconnect the patient cable to the recorder Clean the Patient Cable in the same manner before each procedure Inspecting the Recorder WARNING Inspect patient cable patient leads wires LED or LCD window and enclosure for cracks or breaks before each use Before performing a Holter procedure 1 2 Inspect the patient cable patient lead wires LED or LCD window and enclosure Verify that the patient cable is fully inserted Testing the Recorder Whenever the recorder is serviced or problems are suspected perform these test procedures 1 Verify that the recorder is working properly using an ECG simulator to acquire a standard ECG of known amplitude 7 lead for HR100 and HR300 12 lead for HR1200 Upload the ECG data to the workstation and veri
9. sternum border LA Black L Yellow Left clavicle lateral of sternum border LL Red F Green Lowest rib on left side of chest V1 Brown Red C1 White Red Ath intercostal space on right border of sternum V2 Brown Yellow C2 White Yellow Ath intercostal space on left border of sternum V3 Brown Green C3 White Green Midway between Lead V2 and Lead V4 V4 Brown Blue C4 White Brown Sth intercostal space on left midclavicular line V5 Brown Orange C5 White Black Left anterior auxiliary line at the horizontal level of V4 V6 Blue Violet C6 White Violet Left mid auxiliary line at the horizontal level of V4 RL Green N Black Lowest rib on right side of chest Figure 8 12 Lead Placement HR1200 only 16 Directions for Use Welch Allyn Holter Recorder Service Policy All repairs on products under warranty must be performed or approved by Welch Allyn Unauthorized repairs 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 the product fails to function properly or if you need assistance service or spare parts contact the nearest Welch Allyn Technical Support Center For phone numbers see page ii Before contacting Welch Allyn try to duplicate the problem and check all accessories to ensure that they are not causing the problem When calling please be prepared to provide e Product name and mode
10. with coronary problems or suspected coronary problems This ambulatory electrocardiograph and associated analysis system can be used on patients without limitation on patient age or gender The Holter Recorder procedure is one of the many tools that clinicians use to capture infrequent or activity provoked ECG rhythm abnormalities outside of the physician s office Indications for conducting Holter recording are e Arrhythmias e Chest pain e Unexplained syncope e Shortness of breath e Palpitations e Evaluation of a pacemaker e Regulation of anti arrhythmic drugs e Evaluation of a patient after myocardial infarction e Family history of heart disease Directions for Use Symbols gt gt sj O sd gt Warning Read Carefully Caution Notices Read Carefully Attention See instructions for use Patient Activated Event Meets or exceeds Council Directive 93 42 EEC MDD Class 116 Type BF Medical Equipment Battery Polarity Use AA LR6 Alkaline batteries Single use Use materials labeled with this symbol once only Secure Digital Memory Card Interface Blue Tooth Wireless Communication Technology Recycling Symbol Do not dispose of this product as unsorted municipal waste Prepare this product for reuse or separate collection as specified by Directive 2002 96 EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment WEEE If this
11. Buttons Patient Cable 8 Directions for Use Welch Allyn Holter Recorder Operation To Set the Time HR 300 amp HR 1200 only 1 Remove the battery cover from the recorder see Figure 2 on page 7 2 Remove the Secure Digital Card from the Secure Digital port located at the rear of the device see Figure 2 on page 7 3 Insert two new AA alkaline LR 6 batteries into the recorder battery compartment Note the polarity 4 Slide and secure the battery cover onto the recorder The LCD window shows the time after the recorder self diagnostics is complete approximately 10 seconds Time is displayed in 24 hour time format and the hour digit is blinking 5 Increase the hour shown with the up arrow key or decrease the hour shown with the down arrow key Use the right and left arrow keys to toggle between the hour and minute display Once the time displays remove the batteries To Start a Test Use this procedure for SD Card only For wireless operation refer to the Holter System manual WARNING Inspect patient cable patient leads wires LED or LCD window and enclosure for cracks or breaks before each use See Maintenance on page 17 for more information 1 Prepare the patient according to Patient Preparation on page 10 2 Initialize the Secure Digital Card Refer to the Holter System Application Directions for Use for the Secure Digital Card initialization procedure 3 Remove the battery cover from the recor
12. Holter Recorders HR100 300 1200 Directions for Use Welch Allyn Advancing Frontline C are ii Welch Allyn Holter Recorder Copyright 2006 Welch Allyn All rights are reserved No one is permitted to reproduce or duplicate in any form this manual or any part thereof without permission from Welch Allyn Welch Allyn assumes no responsibility for any injury to anyone or for any illegal or improper use of the product that may result from failure to use this product in accordance with the instructions cautions warnings or statement of intended use published in this manual Welch Allyn HR100 HR300 and HR1200 are trademarks of Welch Allyn SD is a trademark of Toshiba Bluetooth is a trademark of Bluetooth SIG Inc USA SanDisk is a registered trademark of SanDisk Corporation USA Software in this product is Copyright 2006 Welch Allyn or its vendors All rights are reserved The software is protected by United States of America copyright laws and international treaty provisions applicable worldwide Under such laws the licensee is entitled to use the copy of the software incorporated with this instrument as intended in the operation of the product in which it is embedded The software may not be copied decompiled reverse engineered disassembled or otherwise reduced to human perceivable form This is not a sale of the software or any copy of the software all right title and ownership of the software remain with Welc
13. Safe Transit Association pre shipment test procedure March 1977 20 Directions for Use Welch Allyn Holter Recorder Table 8 Protection against ingress of water compliant with IEC 60529 Holter recorder Patient Cable Table 9 Device Classification AECG Device Type Type EMC Class llb IEC Type Type BF Conformance to Regulatory Standards International Electrotechnical Commission e CAN CSA C22 2 No 601 1 M90 e 60601 2 47 2001 e USA UL60601 1 e 601 1 2 conforms to EN 55011 e EN 61000 4 2 1999 e EN 61000 4 3 1995 e EN 61000 4 5 1995 American Advancement of Medical Instrumentation e ANSI AAMI EC38 1998 Device is not defibrillator protected This device does not support Defibrillator Protection requirements defined in section 4 2 5 2 of the requirement Australian Electromagnetic Compatibility e AZ NZS 3200 1 0 Directions for Use Accessories To order accessories call Welch Allyn Technical Support as listed on page ii Table 10 Accessories Item Part Number 3 channel Holter hook up kit 08113 0002 including two 2 1 5 V AA batteries patient diary razor abrading pad alcohol prep pads 7 disposable Holter electrodes and Disposable Pouch Holter electrodes 500 case 45002 0000 Disposable Holter Pouch 08240 0000 5 Lead Patient Cable AHA HR 100 704545 5 Lead Patient Cable IEC HR 100 704546 7 Lead Patient Cable AHA HR
14. able 6 Operation Power source Recording period Storage capacity Storage period Battery Life Pacemaker Detection Effective A D bit Resolution Dynamic Range Freguency Response Sampling Rate AA size LR6 Alkaline battery or batteries Minimum 24 hours continuous SanDisk 256 MB Secure Digital SD card for 200 sps HR100 HR300 HR1200 SanDisk 1 GB Secure Digital SD card for 200 500 1000 sps HR300 HR1200 Data remains valid for gt 5 years or until SD card is initialized Minimum 24 hours ANSI AAMI EC38 1998 0 5 uV 330 mV 0 05 Hz to 100 Hz HR100 200 sps HR300 HR1200 200 500 1000 sps Table 7 Environmental Specifications Operating Temperature 32 F to 113 F 0 to 45 C orage Temperature perating Humidity orage Humidity orage Altitude perating Shock S 0 S Operating Altitude S 0 S orage Shock Operating Vibration Storage Vibration 4 F to 4149 F 20 to 465 C 5 to 95 non condensing 5 to 95 non condensing 500 to 15 000 ft 150 to 4500 m 500 to 50 000 ft 150 to 15500 m 2 95 in 75 mm drop to hard surface on any axis 31 5 in 0 8 m drop to hard surface on any axis 0 0002 G2 Hz from 5 to 350 Hz ramping to 0 0001 G2 Hz from 350 to 500 Hz random vibration spectrum 10 minutes in each of three orthogonal axes Packaged recorder and accessories survived standard drop and vibration procedure published by the National
15. ause undesired operation This equipment has been tested and found to comply with the limits pursuant to Part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and radiates radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communication However there is no guarantee that interference will not occur in a particular installation If this eguipment does cause harmful interference to radio or television reception which can be determined by turning the eguipment off and on the user is encouraged to try to correct the interference by one or more of the following measures e Reorient or relocate the receiving antenna e Increase the separation between the equipment and receiver e Connect the equipment into an outlet on a circuit different from that to which the receiver is connected e Consult the dealer or an experienced radio TV technician for help 26 Directions for Use Welch Allyn Holter Recorder Troubleshooting If the unit malfunctions use the tables below Table 11 Patient Preparation Errors Patient Preparation Error Probable Cause and Solution No signal or low amplitude signal on the Holter Date Code on Hook up kit expired Check the expiration System Preview ECG date on the Hook up kit packaging Poor skin preparation R
16. der see Recorder Illustrations on page 7 4 Insert the Secure Digital Card into the recorder s Secure Digital port located at the rear of the device see figure 1 5 Insert new AA alkaline LR 6 battery or batteries Note the polarity 6 Slide and secure the battery cover onto the recorder e HR 100 The LED flashes green in a sequence of two flashes pause three flashes pause four flashes pause then flashes once approximately every three seconds when operating If the LED flashes yellow any sequence see Troubleshooting on page 26 e HR 300 amp HR 1200 The LCD window shows the time of day after the recorder self diagnostics are complete approximately 10 seconds The recorder is collecting ECG data and functioning properly After the self test the recorder will display ECG on the display for 5 minutes and then display the current time If the recorder does not display time or displays an error code see Troubleshooting on page 26 7 Place the recorder into the carrying case Secure the carrying case and recorder on the patient Directions for Use 9 8 Write the start time date and patient data in the patient diary To Shut Down the Recorder if the recorder does not stop automatically WARNING Discard electrodes after one use 1 Press and hold both EVENT buttons and count the beeps Release the buttons at the start of the seventh beep The HR300 HR1200 LCD will display a sign indicating
17. ecorder is intended for use in the electromagnetic environment specified below The customer or user of the Holter recorder should assure that it is used in such an environment Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge 6 kV contact 6 kV contact Floors should be wood concrete or ceramic tile If floors are ESD x 8 kV air covered with synthetic material the relative humidity should IEC 61000 4 2 8 kV air be at least 30 Electrical fast transient 22 kV for power supply Not applicable burst lines IEC 61000 4 4 1 kV for input output lines Surge 1 kV differential mode Not applicable IEC 61000 4 5 2 kV common mode Voltage dips short lt 5 UF Not applicable interruptions and gt 95 dip in UT voltage variations on for 0 5 cycle power supply input 40 9o Ur lines 60 96 dip in Ur IEC 61000 4 11 for 5 cycles 70 Ur 30 96 dip in Ur for 25 cycles b 9o Ur gt 95 dip in Ur for 5 sec Power freguency 3 A m Not applicable 50 60Hz magnetic field IEC 61000 4 8 Note Ur is the a c mains voltage prior to application of the tes level Directions for Use 23 Electromagnetic Immunity The Holter recorder is intended for use in the electromagnetic environment specified below The customer or user of the Holter recorder should assure that it is used in such an environment
18. emove sensor s repeat skin prep select new position see hookup procedure and apply new electrodes Table 12 Holter Recorder Acquisition Errors displayed on the LED HR 100 only Recorder LED will flash yellow several times pause two seconds and repeat Remove the battery to repeat powerup diagnostics Flashes on LED Description 1 Not used Configuration error recorder SD card contains data or awaiting Bluetooth initialization Low weak battery Secure digital card not detected Internal data processing error Power on self test failed Wireless data link error Error writing file to secure digital card cO a N C wo A CO N Error reading file from secure digital card Table 13 Holter Recorder Acquisition Errors displayed on the LCD HR 300 1200 only LCD Description E1 Not used E2 Configuration error recorder SD card contains data or awaiting Bluetooth initialization E3 Low weak battery Secure digital card not detected E Internal data processing error Power self test failed E Wireless data link error E8 Error writing file to secure digital card E9 Error reading file from secure digital card Directions for Use 27 Limited Warranty HR 100 HR 300 HR 1200 Holter recorder and accessories This product is sold by Welch Allyn under the warranties set forth in the following paragraphs These warranties are extended only to the end user with respect to the purchase of
19. fy the waveforms appear normal with proper amplitude and without distortion or excessive noise 18 Directions for Use Welch Allyn Holter Recorder Storing the Recorder Remove the batteries before storing the recorder Observe the environmental storage conditions See Technical Specifications on page 19 Discarding the Equipment Discard the recorder and accessories according to local laws Please follow the state s recycling laws or your facility s recycling policy to ensure proper disposal of the recorder and accessories For more information on recycling call the Environment Protection Agency or local authorities Attention Do not dispose of this product as unsorted municipal waste Prepare this product for reuse or separate collection as specified by Directive 2002 96 EC of the European Parliament and the Council of the European Union on Waste Electronic and Electrical Equipment WEEE If this product is contaminated this directive does not apply See www welchallyn com weee Directions for Use 19 Technical Specifications Deviations from the range of specifications stated below may result in device performance degradation Table 5 Holter Recorder Characteristics Characteristic HR 100 HR 300 amp HR 1200 Length 3 8 in 96 5 mm 4 4 in 112 mm Width 2 2 in 56 mm 3 1 in 78 mm Height 0 7 in 18 mm 1 4 in 36 mm Weight with battery or batteries 7 oz 198 g 10 oz 283 g and patient cable T
20. h Allyn or its vendors For information about any Welch Allyn product call Welch Allyn Technical Support USA 1 800 535 6663 Australia 61 2 9638 3000 1 315 685 4560 800 074 793 Canada 1 800 561 8797 China 86 21 6327 9631 European Call Center 353 46 90 67790 France 33 1 55 69 58 49 Germany 49 7477 9271 70 Japan 81 3 3219 0071 Latin America 1 305 669 9003 Netherlands 31 157 505 000 Singapore 65 6419 8100 South Africa 27 11 777 7555 United Kingdom 44 207 365 6780 Sweden 46 85 853 6551 Manual Material No 704556 Global Instrumentation part number 004 700 0046 Ver C Manufactured for Welch Allyn 4341 State Street Road Skaneateles Falls NY 13153 USA Manufactured by Global Instrumentation LLC 8104 Cazenovia Road Manlius NY 13104 Contract Medical International GmbH Zur Wetterwarte 50 House 302 EC 01109 Dresden Germany Tel 49 0 351 213 88 88 Fax 49 0 351 213 88 99 Contact European Regulatory Manager E mail tlenihan contract medical com www welchallyn com Printed in USA WelchAllyn Contents Intended Uses x sine be Dee eS Bova DL BAS eh GG Shea Ue dedu 1 Indications tor USC a rud A ase ue ab bee emen e Pe go ey eek dos e Ghee lune LA INN 2 Sym Dol Sen es Ro PRODUCIR US B t Y e es 3 Wannas and Cautions vs v ea id tO Bb eto 5 GS NET STA S Mp 5 CAULONS NY CF NN tot Coto oo tau vede Ve d ait 5 FittOQ UC tIOB et o rt xr e
21. l number and complete description of the problem e Serial number of your product if applicable e Complete name address and phone number of your facility For out of warranty repairs or spare parts orders a purchase order or credit card number e For parts orders the required spare or replacement part numbers If your product requires warranty extended warranty or non warranty repair service please call first the nearest Welch Allyn Technical Support Center A representative will assist you troubleshooting the problem and will make every effort to solve it over the phone avoiding potential unnecessary returns In case a return cannot be avoided the representative will record all necessary information and will provide a Return Material Authorization RMA number as well as the appropriate return address An RMA number must be obtained prior to any return If you have to return goods for service follow these recommended packing instructions e Remove all cables sensors and ancillary products as appropriate before packing unless you suspect they are associated with the problem Wherever possible use the original shipping carton and packing materials Include a packing list and the Welch Allyn Return Material Authorization RMA number It is recommended that all returned goods be insured Claims for loss or damage to the product must be initiated by the sender Directions for Use Maintenance Cleaning the Recorder
22. ligence or accident Welch Allyn s sole and exclusive obligation and buyer s sole and exclusive remedy under the above warranties is limited to repairing or replacing free of charge a product which is reported to Welch Allyn customer service as listed on page ii Welch Allyn shall not be otherwise liable for any damages including but not limited to incidental consequential or special damages There are no express or implied warranties which extend beyond the warranties in this document Welch Allyn makes no warranty of merchantability or fitness for a particular purpose 28 Welch Allyn Holter Recorder 4341 State Street Road PO Box 220 Skaneateles Falls NY 13153 0220 USA W 7 800 535 6663 www welchallyn com elch Allyn Advancing Frontline Care Manual Material No 704556
23. oretically 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 Holter recorder is used exceeds the applicable RF compliance level above the recorder should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the recorder b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m 24 Directions for Use Welch Allyn Holter Recorder Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the Holter recorder The Holter recorder is inte user of the Holter recorder nded for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Holter recorder as recommended below according to the maximum output power of the communications equipment Separation Distance According to Frequency of Transmitter m Rated Max Output 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz Power of Transmitter W d 1 17 1 17 d 2 33 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70
24. ormation in the patient diary how to use the Patient Event Button to avoid contact with water 12 Directions for Use Welch Allyn Holter Recorder Table 2 5 Lead Placement HR100 only Lead AHA Color IEC Color Placement Chi Red Green 4th intercostal space at left border of sternum Ch1 White Red Left clavicle lateral of sternum border Ch2 Brown White Gth intercostal space at the anterior axillary s line Ch2 Black Yellow Right clavicle lateral to the mid clavicle line RL Green Black Lowest rib on right side of chest Figure 4 5 Lead Placement HR100 only CH2 Directions for Use 13 Table 3 7 Lead Placement all models Lead AHA Color IEC Color Placement Chi Red Green Ath intercostal space at left border of sternum Ch1 White Red Left clavicle lateral of sternum border Ch2 Brown White Gth intercostal space at the anterior axillary s line Ch2 Black Yellow Right clavicle lateral to the mid clavicle line Ch3 Orange Orange 6th intercostal space on left midclavicular line Ch3 Blue Blue Manubrium sternum RL Green Black Lowest rib on right side of chest Figure 5 7 Lead Placement all models 14 Directions for Use Welch Allyn Holter Recorder Figure 6 AHA lead cables Directions for Use Table 4 12 Lead Placement HR1200 only 15 AHA AHA IEC IEC Lead Color Lead Color Placement RA White R Red Right clavicle lateral of
25. ply with all appropriate safety EMC and regulatory requirements WARNING Safety System is not designed for use with high frequency HF surgical equipment and does not protect against hazards to the patient WARNING Safety Discard electrodes after one use WARNING Explosion hazard Do not use in the presence of a flammable anesthetic mixture with air or oxygen or nitrous oxide WARNING Fire hazard Replace batteries using AA LR6 alkaline batteries Note polarity A caution statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to equipment failure equipment damage or data loss N Caution US Federal law restricts this device to sale by or on the order of a physician Caution Do NOT use acetone ether freon petroleum derivatives or other solvents to clean the recorder Caution Do NOT let soap or water come into contact with the battery contacts or patient connector pins Caution DO NOT submerse autoclave or steam clean the recorder or the patient cabling Directions for Use Welch Allyn Holter Recorder Introduction Features This manual is written for clinical professionals familiar with monitoring cardiac patients You must read and understand this manual and all other information accompanying the ambulatory electrocardiograph and related options or accessories before e _ using the Welch Allyn Holter Recorder for clinical applications
26. product is contaminated this directive does not apply See www welchallyn com weee 4 Directions for Use 65 20 Latex Temperature range see Technical Specifications Keep dry see Technical Specifications This end up Fragile glass Serial Number Reference Number No Latex No PVC Keep from direct sunlight LED light Welch Allyn Holter Recorder Directions for Use Warnings and Cautions Familiarize yourself with these warnings Specific warnings and cautions are also found throughout this manual Warnings Cautions A warning statement in this manual identifies a condition or practice which if not corrected or discontinued immediately could lead to patient injury illness or death A WARNING Safety For patients with a pacemaker maintain a minimum of 6 inches between the recorder and pacemaker Turn the recorder off immediately and provide appropriate patient care if you suspect the recorder affected the pacemaker WARNING Safety Remove electrodes patient lead wires and recorder from patient before defibrillation WARNING Safety The conductive parts of electrodes and associated connectors for type BF or CF applied parts including neutral electrode should not contact other conductive parts including earth WARNING Safety Inspect recorder and accessories before each use WARNING Safety peripheral equipment and accessories that touch the patient must com
27. successful shutdown The HR100 green LED will stop flashing 2 Press the EVENT button again Did the recorder beep e _ f the recorder does beep the recorder was successfully shut down e lf the recorder beeps repeat the shutdown procedure e Remove the battery and SD card Data transfer to the Workstation Refer to the Holter System Application operating instructions for transferring the Holter procedure data to the Holter PC 10 Directions for Use Welch Allyn Holter Recorder Patient Preparation Holter Procedure Patient Preparation When making the appointment tell the patient e Do not remove any electrodes or disconnect lead wires e Do not swim bathe or shower during the recording period e Do wear loose fitting comfortable clothing to the appointment shirt and pants or blouse and skirt combinations are better than one piece garments Preparing for Electrode Placement on Patient WARNING Safety Leave 5 feet 1 5 meters of open area around the patient during recorder hookup and removal WARNING Safety Do not connect external devices to the recorder Connect patient lead wires only to the patient electrodes WARNING Safety Keep the recorder and patient cable clean especially the components that touch patients Caution Verify that dates on applicable accessories have not expired Table 1 Recommended accessories Accessory Ouantity Electrodes bor AA Alkaline Batteries LR6 1 for HR
28. this product directly from Welch Allyn or Welch Allyn s authorized distributors as new merchandise For a period of 1 year from the date of original delivery to the buyer the recorder software and hardware components are warranted to be free from functional defects in materials and workmanship and to conform in all material respects to the description of the product contained in the Directions For Use and accompanying labels and or inserts For a period of 3 months this same warranty is made for accessories including patient cables provided by Welch Allyn Warranty of accessories purchased separately from listed suppliers will be the responsibility of the listed suppliers This warranty is valid only if a all equipment is approved for use with the recorder by Welch Allyn and are installed according to instructions provided by Welch Allyn or its authorized distributors b the product is properly operated under conditions of normal use in accordance with applicable safety and regulatory requirements c replacements and repairs are made in accordance with the instructions provided by Welch Allyn d only recorder or other software authorized by Welch Allyn is used on the workstation e the product has not been configured modified adjusted or repaired other than by Welch Allyn or by persons expressly authorized by Welch Allyn or in accordance with written instructions provided by Welch Allyn f the product has not been subject to misuse neg
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