ABPM 6100 Hardware Manual Regulatory Affairs Representative Welch Allyn Limited Navan Business Park Dublin Road Navan, County Meath, Republic of Ireland 0297 DIR 80012720 Ver. E Welch Allyn 4341 State Street Road Skaneateles Falls, NY 13153-0220 USA www.welchallyn.
ABPM 6100 Hardware Manual Copyright © Copyright 2013, Welch Allyn. All rights are reserved. To support the intended use of the product described in this publication, the purchaser of the product is permitted to copy this publication, for internal distribution only, from the media provided by Welch Allyn.
ABPM 6100 Hardware Manual Warranty, Service, and Spare Parts Warranty All repairs on products under warranty must be performed or approved by Welch 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.
ABPM 6100 Hardware Manual Limited Warranty Statement Welch Allyn, Inc. warrants that the Welch Allyn CardioPerfect Workstation computer based product you have purchased meets the labelled specifications of the Product and will be free from defects in materials and workmanship that occur within 1 year after the date of purchase. Accessories used with the Product are warranted for 90 days after the date of purchase.
ABPM 6100 Hardware Manual Table of contents 1. OVERVIEW ............................................................................................................................... 6 2. ABPM 6100 MONITOR ........................................................................................................... 10 2.1 2.2 3. Introduction ........................................................................................................................ 10 Operation ..............................
ABPM 6100 Hardware Manual 1. Overview The purpose of this manual is to provide an overview of information that you will need to safely and effectively use the ABPM 6100 monitor. Information about the CardioPerfect Workstation Software is available in the CardioPerfect Workstation software manual. Make sure that you familiarize yourself with all of the safety precautions listed in this chapter before attempting to use either device or the software. Intended Use PROPER USE OF THE ABPM 6100 MONITORS: 1.
ABPM 6100 Hardware Manual EMC Framework of Australia Recycle DIR 80012720 Ver.
ABPM 6100 Hardware Manual Safety and Effectiveness Warnings and Cautions Safety and Effectiveness Warnings Make sure that you are familiar with all Safety and Effectiveness considerations before using the ABPM 6100 monitor. IMPORTANT WARNINGS The following warnings apply to the ABPM 6100 Ambulatory Blood Pressure Monitors: Warning The ABPM 6100 has not been designed for use with high frequency (HF) surgical equipment and does not protect against hazards to the patient.
ABPM 6100 Hardware Manual Caution The ABPM 6100 is intended to be used as an ambulatory blood pressure recorder that is sent home with the patient to record their blood pressure over a 24 hour period. It is used to gather trending information in non-critical settings. It is not intended to provide clinicians with real time monitoring of patients in an ER or critical care environment. The ABPM 6100 monitors are not intended for use on pregnant women or neonates.
ABPM 6100 Hardware Manual 2. ABPM 6100 Monitor 2.1 Introduction The ABPM 6100 Unit is worn by the patient in a belt or shoulder strap and is connected to a cuff, which is wrapped around the non-dominant arm. ABPM 6100 inflates the cuff at preprogrammed intervals throughout the day and measures blood pressure using the oscillometric method, which senses the cessation of pressure waves in the artery when occluded by pressure in the cuff.
ABPM 6100 Hardware Manual 2.2 Operation This section provides a brief overview of the ABPM 6100 unit, how to load the batteries, and the unit controls. The ABPM 6100 features a simple design. One Start/Stop button functions as the primary control. The LCD (liquid crystal display) displays easy-to-read information. The CardioPerfect Workstation Software allows you to program the unit before the study and retrieve data after the study. A single air hose connector allows you to connect the cuff to the unit.
ABPM 6100 Hardware Manual At this point the unit will be ready to upload a BP Study. When the unit is turned on subsequently, the unit will display the following: - Three quick audible beeps. - The number of BP readings (if any) in memory along with a flashing printer symbol for 3 seconds. - One long audible beep.
ABPM 6100 Hardware Manual 3. Interface This section describes how to connect the ABPM 6100 monitor to your PC and how to set up patients for monitoring sessions. To set up the ABPM 6100 for communication to your PC for the first time: Windows XP Windows 7/ Windows 8 1. Right-click on My Computer. 1. Right-click on Computer. 2. Select Properties. 3. Click the Hardware tab. 4. Click the Device Manager. 2. Select Properties. 5. Double-click Ports (COM & LPT) 6.
ABPM 6100 Hardware Manual To configure Welch Allyn CardioPerfect Workstation for use with the recorder: 1. Start Welch Allyn CardioPerfect Workstation. 2. In the File menu, click Settings and click Ambulatory blood pressure. 3. Click the Advanced tab. 4. Select device. 5. Set the COM-port number to the number of the serial port to which the ABP recorder is connected. 6. Click OK to save the settings. 3.1 Preliminary Directive Advise the patient to: - Wear a loose fitting blouse or shirt.
ABPM 6100 Hardware Manual Arm Circumference Cuff Size Reusable sleeve cuffs Pediatric Cuff NA Part 101340 18-27 cm Part 101341 25-35 cm Part 101342 33-40 cm Part 101343 39-46 cm Small Adult Cuff Adult Cuff Adult Plus Cuff Large Adult Cuff 3.4 Traditional Cuff Placement Proper cuff placement is very important to achieve accurate blood pressure measurements. Follow these instructions to ensure the cuff is accurately placed on the patient. Traditional cuff 1.
ABPM 6100 Hardware Manual 3.5 Sleeve Cuff Placement Using an incorrect cuff size could result in erroneous and misleading blood pressure measurements. Sleeve cuff Step 1: To determine the correct cuff size for your patient, follow these simple steps: 1. To find the right sized cuff, wrap the cuff around the patient’s upper arm without sliding the arm through the sleeve. 2.
ABPM 6100 Hardware Manual 3.6 Avoid flexing muscles during the reading Do not remove the cuff between readings Office Readings Once the ABPM 6100 monitor has been properly attached to the patient and the PC interface cable has been removed from the unit, it is important and necessary to perform office readings in order to make sure that the unit is functioning properly and does not cause discomfort to the patient.
ABPM 6100 Hardware Manual PATIENT DO’S AND DON’TS: Finally, familiarize the patient with the following list of do’s and don’ts: Do: Wear a loose fitting blouse or shirt. Record time, symptom/mood and activity/position in the patient diary. Activate a reading (if the Start/Stop button is activated) at the first sign of symptoms. Remain motionless during readings. Keep vehicle driving and travel to a minimum. Bring diary upon return. Don’t: Remove the cuff. Get the monitor wet.
ABPM 6100 Hardware Manual 4. Maintenance and Cleaning Preventative maintenance should be routinely performed to ensure the safe and efficient operation of the ABPM 6100 monitor. In addition, the monitor should be cleaned after each use. Maintenance The following inspections of the ABPM 6100 unit should be performed on a regular basis: The PC connection cable should be inspected for any cracks, exposed wires or other damage. The monitor itself should be visibly inspected for any signs of damage.
ABPM 6100 Hardware Manual 5. Calibration Check Welch Allyn recommends that the calibration of the ABPM 6100 monitor be verified annually by the user using the following procedure: 1. With the ABPM 6100 unit already powered up, remove one of the AA batteries from the battery compartment. Then immediately replace the battery back in its proper orientation, which will result in the unit to start the power up cycle. 2. While the LCD is displaying dashes, press and hold down the Start/Stop button.
ABPM 6100 Hardware Manual 6. Specifications This section provides the unit specifications for the ABPM 6100 ambulatory blood pressure monitor. Power Requirements: Two “AA” alkaline batteries or high capacity rechargeable batteries (NimH). Dimensions: 124 x 70 x 33 mm (approximate). Weight: 270g (including batteries, approximate).
ABPM 6100 Hardware Manual Stereo mini-plug headphone type connector. Operator Control: 1-button control and LCD. Automatic Measurement Intervals: Programmable up to four separate time periods at 5 to 120 minute intervals. 7. Classification Protection against electric shock: Internally powered, Type BF Protection against the ingress of liquids: IPXØ, per IEC 60529 8. Discarding the Equipment Discard the old battery appropriately. • In the USA, call 1800-SAV-LEAD for instructions on recycling it.
ABPM 6100 Hardware Manual 9. Troubleshooting and Error Codes 9.1 Error Codes The ABPM 6100 monitor displays error codes whenever an error situation is encountered. Error codes will display on the unit’s LCD. Error codes that apply to a specific reading will also display in the CardioPerfect Workstation Software when the data is read from the unit. The following table explains error codes generated by the ABPM 6100 monitor along with possible solutions for each error code.
ABPM 6100 Hardware Manual * 9.2 Always return ABPM 6100 monitor to an authorized service center for repairs. Unauthorized service will void all warranties. Troubleshooting The following table contains a list of troublesome scenarios accompanied by suggestions for problem solving. Trouble Cycle starts but cuff will not fully inflate Blood Pressure readings are not displayed during Regular Runs. Patient activation button does not initiate readings while in the Regular Run mode.
ABPM 6100 Hardware Manual 10. Guidance and Manufacturer’s Declarations CAUTION The ABPM6100 needs special precautions regarding EMC and needs to be installed and put into service according to the following EMC information provided. Portable and mobile RF communications equipment can affect the ABPM6100. Electromagnetic Emissions The ABPM6100 is intended for use in the electromagnetic environment specified below. The customer or the user of the ABPM6100 should assure that it is used in such an environment.
ABPM 6100 Hardware Manual Electromagnetic Immunity The ABPM6100 is intended for use in the electromagnetic environment specified below. The customer or the user of the ABPM6100 should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance 6 kV contact 6 kV contact 8 kV air 8 kV air Electrical fast transient/burst ±2 kV for power supply lines n.a.
ABPM 6100 Hardware Manual Electromagnetic Immunity The ABPM6100 is intended for use in the electromagnetic environment specified below. The customer or the user of the ABPM6100 should assure that it is used in such an environment.
ABPM 6100 Hardware Manual Recommended separation distances between portable and mobile RF communications equipment and the ABPM6100 The ABPM6100 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
