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Summary of Contents for Welch Allyn HR100
- Page 1 Holter Recorders HR100/300/1200 HR100 HR300 or HR1200 Recorder Recorder Directions for Use...
- Page 2 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.
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Page 3: Table Of Contents
Contents Intended Use ........... . 1 Indications for Use . - Page 4 Contents Welch Allyn Holter Recorder...
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Page 5: Intended Use
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... -
Page 6: Indications 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 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. -
Page 7: Symbols
Directions for Use Symbols 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 IIb Type BF Medical Equipment. Battery Polarity. Use AA (LR6) Alkaline batteries. Single use. - Page 8 Directions for Use Welch Allyn Holter Recorder 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.
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Page 9: Warnings And Cautions
Directions for Use Warnings and Cautions Familiarize yourself with these warnings. Specific warnings and cautions are also found throughout this manual. Warnings 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. WARNING Safety—For patients with a pacemaker, maintain a minimum of 6 inches between the recorder and pacemaker. -
Page 10: Introduction
You must read and understand this manual and all other information accompanying the ambulatory electrocardiograph and related options or accessories before: • using the Welch Allyn Holter Recorder for clinical applications • setting up, configuring, troubleshooting, or servicing the recorder... -
Page 11: Recorder Illustrations
Directions for Use Recorder Illustrations Figure 1. HR 100 Holter Recorder Patient-Activated Event Buttons Patient Cable Battery Compartment Secure Digital Card Interface Figure 2. HR 300 & HR 1200 Holter Recorder Secure Digital (SD) Card Interface Batteries Patient-Activated Event Buttons Patient Cable... -
Page 12: Operation
Directions for Use Welch Allyn Holter Recorder Operation To Set the Time (HR 300 & HR 1200 only) 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... - Page 13 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 successful shutdown. The HR100 green LED will stop flashing. 2. Press the EVENT button again. Did the recorder beep? •...
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Page 14: Patient Preparation
Directions for Use Welch Allyn Holter Recorder Patient Preparation Holter Procedure Patient Preparation When making the appointment, tell the patient: • Do not remove any electrodes or disconnect lead wires. • Do not swim, bathe, or shower during the recording period. - Page 15 Directions for Use To Prepare the Patient and Place Electrodes 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.
- Page 16 Directions for Use Welch Allyn Holter Recorder Table 2. 5-Lead Placement (HR100 only) Lead AHA Color IEC Color Placement Ch1+ Green 4th intercostal space at left border of sternum Ch1- White Left clavicle, lateral of sternum border Ch2+ Brown White...
- Page 17 Directions for Use Table 3. 7-Lead Placement (all models) Lead AHA Color IEC Color Placement Ch1+ Green 4th intercostal space at left border of sternum Ch1- White Left clavicle, lateral of sternum border Ch2+ Brown White 6th intercostal space at the anterior axillary's line Ch2- Black Yellow...
- Page 18 Directions for Use Welch Allyn Holter Recorder Figure 6. AHA lead cables Figure 7. IEC lead cables...
- Page 19 Directions for Use Table 4. 12-Lead Placement (HR1200 only) Lead Color Lead Color Placement RA White R Red Right clavicle, lateral of 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 4th intercostal space on right border of sternum...
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Page 20: Service Policy
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. -
Page 21: Maintenance
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). 2. Upload the ECG data to the workstation and verify the waveforms appear normal,... -
Page 22: Storing The Recorder
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. -
Page 23: Technical Specifications
Recording period Minimum 24 hours continuous ® Storage capacity 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) Storage period Data remains valid for >5 years or until SD card is initialized... -
Page 24: Conformance To Regulatory Standards
Directions for Use Welch Allyn Holter Recorder Table 8. Protection against ingress of water—compliant with IEC 60529 Holter recorder IPX0 Patient Cable IPX0 Table 9. Device Classification AECG Device Type Type I Class IIb IEC Type Type BF Conformance to Regulatory Standards International Electrotechnical Commission •... -
Page 25: Accessories
Directions for Use Accessories To order accessories, call Welch Allyn Technical Support as listed on page 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) -
Page 26: Electromagnetic Emissions And Immunity Information
Electromagnetic Emissions and Immunity Information Electromagnetic Emissions The Welch Allyn Holter Recorder is intended for use in the electromagnetic environment specified below. The customer or user of the Welch Allyn Holter Recorder should assure that it is used in such an environment. - Page 27 Directions for Use 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. Immunity Test IEC 60601 Compliance Electromagnetic Environment - Guidance Test Level...
- Page 28 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 intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or...
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Page 29: Fcc Information
Directions for Use 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. -
Page 30: Troubleshooting
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. -
Page 31: Limited Warranty
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 this product directly from Welch Allyn or Welch Allyn’s authorized distributors... - Page 32 Welch Allyn Holter Recorder...
- Page 34 4341 State Street Road, PO Box 220, Skaneateles Falls, NY 13153-0220 USA 800 535 6663 www.welchallyn.com Manual Material No. 704556...
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