American Diagnostic Corporation ADview Modular Diagnostic Station Blood Pressure Device for Automated and Manual Measurement User’s Manual
About this Manual This manual describes features and uses of the American Diagnostic Corporation ADview a non-invasive, clinical-grade automated device to measure blood pressure, pulse rate and mean arterial pressure. Optional modules to measure temperature and functional oxygen saturation are available, and their use is also described in this manual.
ADview is a registered trademark of ADC. All other trademark names are the trademarks of their respective holders. The information in this manual is furnished for guidance only, is subject to change without notice, and should not be construed as a commitment by ADC. ADC assumes no liability for errors or inaccuracies that may appear in this manual. © 2010 ADC. All rights reserved.
KEYS AND ACRONYMS Acronyms Acronyms commonly used in this document include: APC An ADC proprietary acronym for “All Purpose Cuff” BP Blood pressure HR Pulse rate K-sound Korotkoff sound MAP Mean arterial pressure NIBP Non-invasive blood pressure EMR/EHR Electronic Medical Records/Electronic Health Records Document Key This manual uses the following icons to call attention to specific instructions or guidance. TIP: A step or process that eases or enhances your use of your ADview device.
Indications for Use The ADview NIBP , Temperature, and Pulse Oximeter device is indicated for use in measuring and displaying Systolic and Diastolic blood pressures, pulse rate, temperature, and functional oxygen saturation (SpO2) of adult and pediatric patients in hospitals, medical facilities, clinics, physicians offices, and other sub-acute environments.
The ADview is not intended for continuous monitoring. Although the blood pressure cuff and cable are defibrillator proof, the temperature probe and SpO2 sensor are not. Do not leave the device unattended while taking measurements on a patient. Only use such accessories as are recommended for use with this device. A list of recommended accessories is on pages 61-66. Do not operate the ADview near flammable anesthetics or volatile vapors. An explosion may result.
If the ADview is dropped or mishandled, please have it checked by a authorized service center before bringing it back into use. The ADview is not intended for patients connected to a cardiopulmonary bypass machine. At least every three months, inspect probes, cords and accessories for fraying or other mechanical damage. Replace as necessary. Check the calibration of your ADview at least once a year.
TABLE OF CONTENTS Changes and Reissues ........................................................................................................................ii Copyright Information ........................................................................................................................ii KEYS AND ACRONYMS .......................................................................... IV Acronyms ...................................................................................................
Mounting Your Device ......................................................................................................................... 15 Mounting the Device on a Wall ........................................................................................................ 16 Affixing the Device to a Mobile Stand .............................................................................................. 16 Placing the Device on a Tabletop ...........................................................
Attaching the Pulse Oximetry Module .............................................................................................. 35 Storage, Shutdown, Transport ............................................................................................................ 36 Storage ........................................................................................................................................... 36 Moving Your Device ..................................................................
GETTING TO KNOW THE ADVIEW Your ADview is a model of functionality, offering consistent blood pressure measurements along with reliable temperature and functional oxygen saturation readings. Package Contents Upon opening your kit, please ensure that all listed contents are included. If any contents are missing or damaged, please contact ADC. The ADview Kit The ADview kit contains your rechargeable battery powered device.
Accessory Modules Accessory modules that you can purchase from your distributor or ADC to enhance usability of your ADview include: • A temperature module that includes the oral/axillary probe and one box of disposable probe covers. A rectal probe option is available separately. • A pulse oximetry module with an adult reusable finger sensor and 6-foot sensor extension cable. Other Accessories Many other accessories and sources for purchasing them are listed in the Appendix on pages 58-66.
A Bird’s Eye View BP module Automatic button Power button (recessed) Sphygmode manual button Blood pressure hose connector Power connector (rear panel) Connectors on the main BP module • Power Connector: Connects to the power supply. • Blood Pressure Hose Connector: Connects to the 8-foot pressure hose. Buttons The buttons are used for all actions on the interface, and provide tactile feedback when pressed.
Buttons on the main BP module Button Functionality for the BP Module Button Device Status Action Result Select for less than 2 seconds Start an automatic BP measurement. Select for 2 to 5 seconds Redisplay last measurement values for all modules. Select for more than 5 seconds Clear last measurement values for all modules. Taking an automatic or Sphygmode BP Select Aborts the BP measurement in progress.
Systolic blood pressure Pressure column Diastolic blood pressure Mean arterial pressure icons Pulse rate icon Warning icon Information on the BP module display Cuff/hose error icon Power level indicator Pulse rate/ Mean arterial pressure/Status code • Systolic blood pressure: At the end of a measurement or when the last measurement is recalled, the patient’s systolic BP is displayed. During a measurement, the cuff pressure is displayed.
Temperature units select (recessed) Temperature mode select SpO2 sensor connector Buttons on the optional temperature module • Temperature units select: Recessed momentary switch that toggles the display between °F and °C. • Temperature mode select (symbol on button: ): Momentary switch that selects oral vs. axillary measurements for the oral temperature probe, and selects predictive vs. direct measurement methods for all probes.
Buttons on the optional pulse oximetry module: None Connectors on the optional pulse oximetry module • SpO2 sensor connector: Connects to a SpO2 extension cable or sensor. See page 60 for compatible accessories.
Optional temperature and pulse oximetry displays Celsius icon Fahrenheit icon Temperature Warning icon Signal quality SpO2 Warning icon Information on the optional temperature module display • Temperature: At the end of a measurement, the patient’s temperature is displayed. During a measurement, displays the probe type and related information. If the warning icon is lit, displays the status code. See page 39 for details. • Celsius icon: When lit, the value below is displayed in degrees Celsius.
Information on the optional pulse oximetry module display • SpO2: At the end of a measurement, the functional oxygen saturation of the patient is displayed. If the warning icon is lit, displays the status code. See page 40 for details. • Signal quality: During a measurement, indicates the quality of signal from the pulse oximeter sensor. • Warning icon: When displayed, indicates that the system needs to be checked. See page 40 for details.
ICON/DISPLAY INDICATES… Battery fully charged Battery is charging (segments animated) Power-off state As the charge level drops, the segments will be turned off in sequence from the right to the left. The battery charge is very low. Recharge before using. (segment flashing) Visual Cues - Blood Pressure Module Icons and numeric displays on your device assist you in taking quick and accurate readings. ICON/DISPLAY INDICATES… The systolic BP, read in mmHg, displays immediately below this symbol.
ICON/DISPLAY INDICATES… Warning! The device is unable to take a valid reading. See page 38 for troubleshooting details. A measurement is in progress. If the column is rising, the cuff is being inflated; if the column is falling, the cuff is deflating. Each segment lit is approximately equivalent to 10 mmHg. Visual Cues - Temperature Module ICON/DISPLAY INDICATES… Temperature shown in degrees Fahrenheit. Temperature shown in degrees Celsius. The unit is taking a measurement in predictive measurement mode.
ICON/DISPLAY Temperature value flashes in a downward direction Temperature value is steady (no flashing) INDICATES… Final measurement is less than 86°F /30.0°C. This is the final temperature value. Visual Cues - Pulse Oximetry Module ICON/DISPLAY INDICATES… The unit is taking a measurement. “Traveling dash” in SpO2 display Warning! Indicates an error in the optional pulse oximetry module. Please refer to the troubleshooting section on page 40.
QUICK START GUIDE If the device is off, turn it on by depressing the power button on the right side. Measuring Blood Pressure and Pulse Rate Automatically 1. Wrap an appropriately sized cuff (sizes are tabulated on page 20) snugly around the upper arm midway between the elbow and shoulder. 2. Ask the patient to stay still and quiet before taking the measurement. 3. Press the automatic button shown in the systolic display. 4.
2. Wait for the device to beep before placing the probe carefully under the patient’s tongue as denoted by the heat pockets shown to the right. The posterior medial sublingual pocket is preferred for accuracy. Hold the probe in place so that its tip maintains tissue contact. Close the patient’s mouth. During measurement, a “traveling dash” is displayed. In approximately 1015 seconds, you will hear a long beep and the temperature reading will display. 3.
SETTING UP THE ADVIEW Safety Precautions As a clinically trained professional using the ADview, your responsibilities include safeguarding your patients, yourself and your equipment. Many setup functions will be performed either only once or very occasionally, and it is important that you pay close attention. Before you set up your ADview, please review these safety guidelines.
Mounting the Device on a Wall Mount the ADview on the wall in place of an aneroid manometer. To affix your ADview to the wall: 1. Attach the bracket to the wall using 4 wall screws, and the basket using 2 screws. 2. Attach the wall bracket adapter to the rear panel of the BP device using the 3 screws. 3. Position the adapter onto the rivets of the wall bracket and slide the device down until it locks into place.
The charging status is indicated by the rotating sequence of lit segments in the battery icon. When the battery is fully charged, all segments will be lit . A fully charged battery provides enough power for the device to make at least 200 measurements within a 12-hour period. The battery is guaranteed to last for 200 readings in an 8 hour period per charge.
With the device powered on, select the unit of measurement for temperature by depressing the recessed button on the side of the temperature module to toggle between the °C and °F icons. The selected icon will be lit in the display and becomes your default selection. Bluetooth Wireless Communication If your ADview has the optional Bluetooth wireless communication capability, please contact your IT administrator for configuration with your EMR/HER system or communication network.
MEASURING BLOOD PRESSURE WITH THE ADVIEW Your ADview device is designed to take accurate blood pressure readings by the oscillometric method. Systolic pressures from 60 to 270 mmHg and diastolic pressures from 30 to 170 mm Hg lie within the range of your device. In most cases, you will be able to take accurate blood pressure (BP) and pulse rate (HR) measurements within 30-40 seconds.
Selecting the Right Cuff Your device comes with durable two-piece All Purpose Cuffs (APC) from ADC. Cuffs are available in a range of sizes, from Child to Thigh. Note that your ADview works optimally with APC cuffs. Using the table below, select a cuff you estimate to be of the right circumference: 2. Wrap the cuff around the patient’s upper arm midway between the elbow and the shoulder. 3.
Taking a Measurement The ADview allows you to take BP measurements automatically like a monitor or manually like a sphygmomanometer using manual Sphygmode™. In automatic mode, the cuff inflates and deflates automatically. Initial inflation reaches a cuff pressure of 160 mmHg; the cuff then re-inflates as necessary to obtain a reading. Deflation is optimized to reduce measurement time and obtain an accurate result.
Taking a measurement on each arm helps rule out dissecting aneurysms, coarctation of the aorta, vascular obstruction and possible errors in measurement.1 You can find more tips like this in the American Heart Association’s current scientific statement on recommendations for blood pressure measurement. Taking a Manual Sphygmode Measurement 1. With the patient prepped as described earlier (page 19), and the device powered on, palpate the brachial artery at the antecubital fossa.
K-Sounds: A Primer Korotkoff sounds, commonly called K-sounds, are the sounds you detect through your stethoscope when you measure blood pressure with a sphygmomanometer or an aneroid device. Named for the Russian physician who identified them, there are five phases of K-sounds, each phase characterized by a distinct volume and quality of sound. K-sounds are heard through the stethoscope as the blood pressure cuff deflates. The first sound, K-1, is heard when cuff pressure equals systolic pressure.
MEASURING TEMPERATURE WITH THE ADVIEW Your ADview device can measure temperature with the optional temperature module. This module enables you to take rapid, accurate temperature measurements ranging from 86°F-109.4°F. Typically, predictive readings are obtained within ten to fifteen seconds, and direct readings within two minutes. The module is equipped with the temperature probe for oral/axillary measurement, color-coded blue. A rectal probe that is color-coded red is optionally available.
• Dispose used probe covers in accordance with current medical practices or local regulations regarding disposal of infectious, biological medical waste. • Note that proper placement of the probe is essential to the accuracy of the measurement. Taking an Oral Temperature 1. Remove the blue probe from its holder and secure a disposable cover on it. The probe preheating process begins with the flashing display of the type of measurement, . 2.
measurement. 4. After 10-15 seconds, a long beep signals the end of the measurement cycle. The temperature will display for two minutes or until you initiate a new measurement. 5. Remove the probe, discard the probe cover and place back in the probe holder. Note the temperature reading. Taking a Rectal Temperature 1. Remove the blue probe and well by sliding the pieces upward until they detach. 2.
MEASURING OXYGEN SATURATION WITH THE ADVIEW The ADview optional pulse oximeter module measures functional oxygen saturation ranging from 40% to 100%. A signal strength display assists the clinician in the proper placement of the sensor. The ADview is a spot check device and is not used for patient monitoring. Therefore, there are no SpO2 alarms.
• When selecting a sensor site, give priority to an extremity free of an arterial catheter, blood pressure cuff or intravascular infusion line. • Clean reusable sensors after use. • Ensure that the optical components of the sensor are properly affixed to the patient and aligned. • Artificial nails, or dark shades of nail polish, may reduce light transmissions and affect pulse oximetry accuracy. Clean off nail polish or detach artificial nails before applying the sensors.
seconds (see page 30 for details).
MANAGING READINGS Recalling the Last Set of Readings To redisplay the last set of readings, depress the automatic button on the BP module for more than two seconds until the last reading is displayed. If your ADview has temperature and/or pulse oximetry modules, the last set of readings includes these readings as well. If the last attempted reading resulted in an error and/or warning, then this will be displayed.
MAINTAINING THE ADVIEW Routine Maintenance Establishing simple care guidelines helps protect the performance and life of your ADview. On a routine basis, you should inspect the device, cables and pneumatic hoses for cracks, fraying or kinks and immediately replace any damaged parts. Remember to check the calibration of the BP module annually. If available, a biomedical technician may help in maintaining your equipment. Cleaning Cleaning the Device 1.
Prying the finger clip sensor to an angle greater than 90° can permanently damage its casing. Checking the Calibration of Your Device It is recommended that you check the BP calibration of your ADview once a year. To check calibration: 1. Start with the device powered off. While holding down the automatic button on the front of the BP module, toggle on the power button on the right side of the main enclosure.
To replace the battery: 1. Remove the four screws securing the battery bay door. 2. Carefully remove the battery from the battery bay, being careful not to pull on the wires attached to the battery terminals. 3. Disconnect the wires from the battery terminals. 4. The rechargeable battery contains lead. Please dispose of the old battery properly. 5. Connect the wires to the terminals of the replacement battery, ensuring the red wire is attached to the red terminal and the black wire to the black terminal.
Attaching the Temperature Module Should you need to attach or remove the temperature module; the following instructions give an overview of its attachment to the BP module. The temperature module attaches to the top of the BP module. It is made up of the following two pieces: A • Part A with the display. • Part B, the probe holder, which holds the temperature probe and probe cover box. B 1. Using the power button on the right side of the BP module, ensure that the ADview is off. 2.
4. Attach the temperature probe connector to part B as follows: with the black surface facing downward, hold the probe connector end against the notches on the probe holder, as shown in red (step 1 shown below). 5. Rotate the connector upwards until it snaps securely into place (step 2 shown above). The black surface faces outward and the cord extends upward. 6.
3. Slide the pulse oximetry module along the guides on the bottom of the main BP module from front to back until it snaps into place. All the segments of the pulse oximetry module display will light when the modules have been connected correctly. 4. Turn the device on using the power button on the right side of the BP module. At the end of the start-up sequence, the pulse oximetry module display will be blank except for the “%SpO2” symbol. 5. Turn the device off.
1. Detach the cuff, temperature probe, SpO2 sensor, power supply, and other ancillary products from the device. 2. Disconnect the battery and remove it from the device. 3. Place the device in the original shipping carton, preferably with its original packing material. 4. Ensure that the device will be kept at between -20°C (-4°F) and 55°C (131°F) and in relative humidity less than 90% during transshipment.
TROUBLESHOOTING The troubleshooting chart provides pointers on diagnosing issues associated with error or status codes. Problem: The ADvew will not power on. Solutions: 1. The ADview must be plugged in to charge before first use. Problem: My ADview is not communicating with my EMR/EHR system or network Solutions: 1. Be sure your ADview is equipped with the Bluetooth option. 2. Your ADview and wireless system must be configured to communicate.
6. 7. 8. 9. Check that the correct size cuff is being applied. Check that the cuff is not leaking air. Check that the hose connections are not damaged or loose. Take another BP reading. Status Codes: 800, 900, 910, 970, 980, or 990 Problem: System error Solutions: 1. Take another measurement. 2. If this is unsuccessful, power down, then power up the unit using the power button on the right side of the unit. If the error does not recur immediately, take another measurement. 3.
Status Code: 20 Problem: Hardware error Solutions: 1. Take another measurement. 2. If this is unsuccessful, power down, then power up the unit using the power button on the right side of the unit. If the error does not recur immediately, take another measurement. 3. If the error recurs, remove power from the unit (unplug any power supplies and remove the battery), then reconnect the power. If the error does not recur immediately, take another measurement. 4.
Problem: Inadequate signal strength Solution: If there is no measurement and the signal quality is low, try a different site or sensor. Avoid fingers with nail polish or artificial nails. If there is no improvement in signal quality, then discontinue use.
FAQs Can I obtain replacement copies of the ADview CD and manual? Copies of the ADview manual are available through the Customer Service area of our website. To download the manual, please visit www.adctoday.com/adview. For a replacement CD, please email Customer Service at info@adctoday.com How do I clean the ADview device? The ADview requires only minimal cleaning. Wipe it down occasionally with a soft, damp cloth. Never immerse the device or apply cleaning fluid or solvents.
Could I use the ADview to measure blood pressure during a stress test? Although your ADview is a robust device that has been manufactured with motion tolerance, it is not intended for use during stress testing. Should I wait between temperature measurements? Yes. Accurate temperature measurement requires the probe to be at normal room temperature. After taking a measurement, wait for the probe to return to room temperature or wipe the probe with an alcohol wipe before taking a subsequent measurement.
Web Resources www.adctoday.com/adview Service Centers For customers in the Americas American Diagnostic Corporation Service Department 55 Commerce Drive Hauppauge, NY 11788 USA Tel: 631.273.9600 Fax: 631.273.
For customers in Europe, the Middle East, and Africa American Diagnostic Corporation Oakfield Estate Eynsham, Oxfordshire England Tel: +44 (0) 1865.884.234 Fax: +44 (0) 1865.884.235 For customers in Asia and the Pacific American Diagnostic Corporation Level 19, Two, International Finance Centre 8, Finance Street, Central Hong Kong Tel: +852.2251.1949 Fax: +852.2251.
SPECIAL SITUATIONS Special Situations Unique circumstances, such as the patient’s age or physiological disturbances, require you to take special care while measuring blood pressure or vital signs. The more common examples of such circumstances are described here, to assist you in using your ADview optimally under such conditions.
Measuring Blood Pressure in the Emergency Room Measuring blood pressure in the emergency room can be done through automated blood pressure measurements. For critically ill or injured patients, blood pressure should be measured through the invasive arterial pressure method.
APPENDICES Specifications Patient population: Adult and pediatric patients (age 3 and above).
Safety systems: Independent hardware over-pressure circuit and redundant software overpressure algorithm to limit cuff pressure to less than 330 mmHg. Independent hardware timing circuit and redundant software timer algorithm to limit the duration of a blood pressure cycle to less than 180 seconds. Dimensions: Length = 5.5 inches, Height = 11.5 inches, Width = 3.8 inches; Length =14.0 cm, Height = 29.2 cm, Width = 9.7 cm Standards: UL60601-1, CAN/CSA C22.
This equipment has been tested and found to comply with the limits for medical devices to IEC60601-1-2: 2001. These limits are designed to provide reasonable protection against harmful interference in a typical medical installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity.
SYMBOL DESCRIPTION CE approval or Recognized component certified by UL to both Canada and US requirements TUV Canada and US approval TUV International approval Earth ground Output connection configuration – positive voltage; negative shield 51
Guidance and manufacturer’s declaration – electromagnetic emissions The ADview is intended for use in the electromagnetic environment specified below. The customer or the user of the ADview should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment – guidance RF emissions Group 1 The ADview uses RF energy only for its internal function.
Guidance and manufacturer’s declaration – electromagnetic immunity The ADview is intended for use in the electromagnetic environment specified below. The customer or the user of the ADview should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment – guidance Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or discharge (ESD) ±8 kV air ±8 kV air ceramic tile.
Guidance and manufacturer’s declaration – electromagnetic immunity The ADview device is intended for use in the electromagnetic environment specified below. The customer or the user of the ADview device should assure that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment and the ADview device The ADview device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
FCC RF Interference Statement: 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.
Limited Warranty ADview Device American Diagnostic Corporation provides the original purchaser the following limited warranty from date of invoice. BP, Temp and SPO2 Modules: 2 years parts and labor Cuffs: 2 years Wall Mount, Table Caddy and Mobile Stand: 2 years Battery: 1 year (added) Cables and all other accessories: 90 days American Diagnostic Corporation warrants each instrument to be free from defects in material and workmanship.
Purchasing Parts and Accessories We recommend that you purchase parts and accessories for your ADview from your authorized ADview distributor. A consolidated list of parts and accessories appears below.
9000BPTO ADView Battery Tabletop System, BP & Temperature BP Device with Temp, Rechargeable Battery, and tabletop stand ADview Battery Tabletop System, BP & SpO2 BP Device with SpO2, Rechargeable Battery, and tabletop stand 9000D 9000BPS 9000D ADview Accessories Item # Item Name Item Description 9000TO ADview Temperature Module, Oral Thermometry Module for ADview BP with blue probe 9000TR ADview Temperature Module, Rectal Thermometry Module for ADview BP with red probe 9000S ADview SpO2 Modu
850-9000-11AN All Purpose Cuff, Adult Blood Pressure Cuff with threaded screw type connector, Range: 23-33 cm, Color: Navy Blue 850-9000-12XBD All Purpose Cuff, Large Adult Blood Pressure Cuff with threaded screw type connector, Range: 31-40 cm, Color: Burgundy 850-9000-13TBR All Purpose Cuff, Thigh Blood Pressure Cuff with threaded screw type connector, Range: 38-50 cm, Color: Brown Pulse Oximetry Accessories Item # Item Name Item Description 9000SP Adult digit reusable oximetry sensor (2010)
Miscellaneous Accessories Item # Item Name Item Description 9000M Mobile stand kit Includes base, pole, power supply holder, storage basket, handle, and assembly instructions 9000D Tabletop stand kit Includes power supply holder 9000W Wall mount kit Includes wall mountable basket 952-025 Basket Wall mountable 9000AC9V Power supply for the ADview Battery Input: 100-240 V, 50-60 Hz; Output: +9 V; medical grade 9000PCEU EU power cord Power or mains lead with Type E and F hybrid, CEE 7/7, tw
American Diagnostic Corporation www.adctoday.com/adview American Diagnostic Corporation 55 Commerce Drive Hauppauge, NY 11788 USA Tel: 631.273.9600 1.800.232.2670 Fax: 631.273.9659 SunTech Medical, Ltd. Level 19, Two, International Finance Centre 8, Finance Street, Central Hong Kong Tel: +852.2251.1949 Fax: +852.2251.1950 SunTech Medical, Ltd. Service Department Oakfield Industrial Estate Eynsham, Oxfordshire OX29 4TS UK Tel: +44. 1865.884.234 Fax: +44. 1865.884.