ADC 9005BPTO User Manual

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ADC® ADView® 2 Modular Diagnostic Station
User Manual
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2
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93-9005-00 ADView 2 User Manual | 2 September 1, 2016
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Changes
This manual is identified as item number: 93-9005-00. The most recent version is available for download from the ADC website. Should you notice errors or omissions in this manual, please notify us at:
American Diagnostic Corporation 55 Commerce Drive Hauppauge, NY 11788 Tel: 1.800.ADC.2670
1.631.273.9600 Fax: 1.631.273.9659 Email: customerservice@adctoday.com
Web: www.adctoday.com
Copyright Information
All content in this manual is the property of American Diagnostic Corporation and is provided solely for purposes of operation, maintenance or service of the ADView 2. This manual and the ADView 2 described herein are protected under copyright law under which states they may not be copied, in whole or in part, without written consent of ADC.
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.
© 2016 American Diagnostic Corporation. All rights reserved. ADC, the ADC logo, and ADView are registered trademarks of American Diagnostic Corporation. All other trademarks are the property of their respective owners.
Welcome to the ADC® ADView® 2
Thank you for choosing the ADC® ADView® 2 Modular Diagnostic Station for accurate spot-checking of vital signs.
The ADView 2 is designed to be simple and efficient to use, and features:
A contemporary, compact design
An integrated handle for easy mobility
Automatic BP checks
Averaging of multiple BP readings
Optional use of stethoscope for traditional auscultatory BP measurement
A robust memory
Connection options for EMR system integration
Multiple options for pulse oximetry and temperature measurement
ADView 2 Description and Operation
The ADView 2 can perform automatic blood pressure, pulse oximetry and body temperature measurements for clinical professionals. For measuring blood pressure, a blood pressure cuff is placed around the patient’s non­dominant upper arm. The cuff is inflated automatically and blood pressure is determined by the oscillometric method—which senses pressure waves in the artery when occluded by pressure in the cuff. Measurement of the frequency of the pressure waves enables heart rate to also be measured. The pulse oximetry function non-invasively measures the patient’s percent oxygen saturation of arterial hemoglobin using principles of plethysmography via an SpO2 sensor placed on the patient’s finger. Temperature can be measured using an oral/axillary or a rectal temperature probe containing a thermistor that generates a voltage based on changes in temperature. These voltages are recorded by the temperature circuitry. The ADView 2 is a portable device, approximately 205 x 190 x 140 mm in size and weighs approximately 1440 g without battery. Control buttons allow the user to stop/start a BP measurement, save a set of measurements to memory, change between BP modes, and return to the home screen. There is also a selection knob that is used to scroll and select different device options. The backlit LCD display shows the user device status and measurement information. The device uses a microprocessor with software, which is not accessible to the user. The unit is powered by a single rechargeable lithium-ion battery at the rear of the device. Two USB-A port connections can be used to connect, an optional printer, barcode scanner or Wi-Fi dongle. There is also RJ11 Ethernet port for network connectivity, and a mini-USB port used to connect the device to a PC or laptop for advanced device configuration.
Note: For purposes of this manual, the ADView 2 (Model 9005) may be referred to as “the ADView 2, or “the device.”
93-9005-00 ADView 2 User Manual | 5 September 1, 2016
Table of Contents!
Changes!...........................................................................!3!
Copyright!Information!....................................................!3!
Welcome!to!the!ADC®!ADView®!2!.................................!4!
ADView!2!Description!and!Operation!.............................!4!
1.! Safety!Considerations!........................!6!
Intended!Use!...................................................................!6!
Indications!for!Use!..........................................................!6!
User!Responsibility!.........................................................!6!
Possible!Adverse!Reactions!.............................................!7!
Icons,!Symbols!and!Abbreviations !..................................!9!
Commonly!Used!Abbreviations!....................................!10!
2.! Setting!Up!the!ADView!2!..................!10!
Unpacking!the!Monitor!.................................................!10!
Rear!Panel!Configuration!..............................................!11!
Side/Temperature!Panel!Configuration!........................!12!
Side/SpO2!Panel!Configuration!.....................................!12!
Install!Batteries!.............................................................!13!
Battery!Disposal!............................................................!13!
Attach!Connections!to!the!Device!................................!14!
Mounting!Options!.........................................................!14!
System!Configuration!....................................................!14!
3.!Getting!to!Know!the!ADView!2!............!15!
Measurement!Display!...................................................!15!
Control!Panel!................................................................!18!
Monitor!Setup!...............................................................!18!
Visual!Alarms!................................................................!18!
4.!Good!to!Know!Before!You!Begin!.........!19!
Power!Modes!................................................................!19!
Documenting!Measurements!.......................................!19!
Printing!..........................................................................!19!
Saving!Measurements!...................................................!20!
5.!!Using!ADView!2!for!BP!Measurement!21!
Step!1:!Preparing!the!Patient!........................................!21!
Step!2:!Select!Between!Adult!Vs!Pediatric!Mode!.........!21!
Step!3:!Select!Measurement!Mode!..............................!22!
Step!4:!How!to!Measure!BP!in!Each!Mode!...................!24!
Step!5:!Record!Results!..................................................!25!
Step!6:!Prepare!for!New!Patient!...................................!25!
6.!Using!ADView!2!for!Heart!Rate!
Measurement!.........................................!25!
BP!Heart!Rate!Measurement!........................................!25!
SpO2!Heart!Rate!Measurement!....................................!25!
7.!Using!ADView!2!for!Pulse!Oximetry!....!26!
General!Principle!of!Operation:!....................................!26!
System!Description:!......................................................!28!
Taking!SpO2!Measurements:!.........................................!28!
Special!Notes!for!Masimo!SET!SpO2!Module:!...............!28!
Special!Notes!for!ChipOx!SpO2!module:!........................!30!
8.!Using!ADView!2!for!Temperature!
Measurement!........................................!32!
Covidien!Filac!3000!Thermometry!Module!...................!32!
Oral!Temperature!Taking!..............................................!32!
Axillary!Temperature!Taking!.........................................!33!
Rectal!Temperature!Taking!...........................................!33!
Other!Temperature!Settings!.........................................!33!
9.!Using!ADView!2!EMR!and!Memory!
Functions!...............................................!34!
Memory!Mode!..............................................................!34!
EMR!Transmissions!.......................................................!35!
10.!Taking!Care!of!Your!ADView!2!..........!36!
Cleaning!........................................................................!36!
Preventative!Maintenance!............................................!37!
Replacing!and!Disposal!of!the!Battery!..........................!37!
Battery!Disposal!............................................................!37!
Product!Disposal!...........................................................!37!
Cuff!Disposal!.................................................................!37!
Routine!Calibration!.......................................................!37!
11.!Accessories!&!Replacement!Parts!.....!38!
Complete!Modules!(when!purchased!separately)!........!38!
Mounting!Platforms!......................................................!38!
Blood!Pressure!Cuffs!.....................................................!38!
Power!Supplies!..............................................................!39!
Temperature!Accessories!..............................................!39!
SpO2!Accessories!..........................................................!39!
Other!Accessories!.........................................................!39!
12.!Status!Messages!&!Alarms!................!40!
Status!Messages!............................................................!40!
Out!of!Range!Measurements!........................................!42!
Service!Centers!.............................................................!43!
13.!Frequently!Asked!Questions!.............!43!
14.!Technical!Information!......................!44!
EMC!Statement!.............................................................!44!
Specifications,!General!..................................................!48!
Specifications,!Blood!Pressure!Measurement!..............!48!
Notes!on!Blood!Pressure!Data!......................................!49!
Specifications!SP02!Sensor!............................................!49!
Specifications!Temperature!Sensor!..............................!49!
Limited!Warranty!..........................................................!50!
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93-9005-00 ADView 2 User Manual | 6 September 1, 2016
1. Safety Considerations
Intended Use
The ADView 2 is a clinical-grade, automated blood pressure measurement device with optional temperature and pulse oximetry modules for spot-check vital sign measurements in physician offices, long-term care facilities, and low-acuity areas in hospitals. The ADView 2 can be used in combination with a clinical IT network to transfer and store patient measurement data on an EMR system. !
Indications for Use
The ADView 2 is a non-invasive oscillometric spot-check vital signs device. The ADView 2 is capable of measuring and displaying brachial systolic and diastolic blood pressure, heart rate, percent oxygenated hemoglobin (SpO2) and body temperature on children 3 years of age to adults. This device is intended for use by a qualified clinician when it is necessary to take a single or a series of vital signs measurements on a patient. The ADView 2 is only for measurement, recording and display. It makes no specific diagnoses.
The ADView 2 is intended to be used on adult and pediatric patients using appropriately sized ADC ADView 2 blood pressure cuffs.
User Responsibility
Your ADView 2 is designed to perform in conformity with the description thereof contained in this operation manual and accompanying labels and inserts, when assembled, operated, maintained and repaired in accordance with the instructions provided.
Further, the user of this device bears sole responsibility for any malfunction that results from improper use, faulty maintenance, improper repair, damage or alteration by anyone other than ADC or authorized service personnel.
Use of ADView 2
Use only ADView 2 blood pressure cuffs supplied by ADC.
Observe the patient carefully during the measurement. Ensure pressure compatibility to all patients. If any abnormality occurs, either in the unit or the patient, suspend the operation immediately and disconnect the BP cuff, SpO2 sensor and thermometer (if applicable) from the patient.
Accuracy of any BP reading or oxygen saturation measurement may be affected by the position of the patient, their physical condition and use outside of the operating instructions detailed in this guide. The interpretation of BP and oxygen saturation measurements should only be made by a physician.
Safety and effectiveness when used with pregnant women, children under 3 years of age and neonates have not been established.
Pulse Oximetry (SpO2)
ChipOx SpO2 Module: Use only pulse oximeter sensors supplied by ADC or original Nellcor
TM
pulse oximeter sensors
supplied by Covidien® (except for forehead reflectance sensors).
Masimo® SpO2 Module: Use only original Masimo pulse oximeter sensors and cables.
Check the application site of the SpO2 sensor frequently to confirm proper positioning of the sensor and to check the circulation and skin sensitivity of the patient.
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Wireless Networking
When connecting this device to a wireless network, it is important to use only the hardware specified by ADC (see Accessories section for details). Unsupported USB accessories, including unsupported wireless adapters, have been intentionally disabled and will not function with this device.
Possible Adverse Reactions
In the area of the BP cuff or SpO2 sensor, allergic exanthema (symptomatic eruption) may result, including the formation of urticaria (allergic reaction including raised edematous patches of skin or mucous membrane and intense itching) caused by the fabric material of the cuff or sensor.
Following the application of the BP cuff, petechia formation (a minute reddish or purplish spot containing blood that appears in the skin) or Rumpel-Leede phenomenon (multiple petechia) may appear on the arm, which may lead to idiopathic-thrombocytopenia (spontaneous persistent decrease in the number of platelets, associated with hemorrhagic conditions) or phlebitis (inflammation of a vein).
!Warnings and Cautions
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WARNING: Do not attach the cuff to a limb being used for IV infusions or any other intravascular access, therapy or an arteriovenous (A-V) shunt. The cuff inflation can temporarily block blood flow, potentially causing harm to the patient.
WARNING: Pressurization of the cuff can temporarily cause loss of functionality of SpO2 if simultaneously using device on the same limb.
WARNING: Not designed for neonates.
WARNING: Do not apply the BP cuff to a limb being used for IV infusions as the cuff inflation can temporarily block
the infusion, causing harm to the patient.
WARNING: Check frequently by observing the limb that operation of the AUTOMATED SPHYGMOMANOMETER does not result in prolonged impairment of the circulation of the patient.
WARNING: The cuff should not be applied over a wound as this can cause further injury.
WARNING: The cuff should not be placed on the arm on the side of a mastectomy. In the case of a double
mastectomy use the side of the least dominant arm.
WARNING: The ADView 2 is NOT defibrillator protected.
WARNING: Do not use in the presence of flammable anesthetics or other flammable substances in combination with
air, oxygen-enriched environments, or nitrous oxide.
WARNING: Do not use the device if it has failed its diagnostics self-test, or if it displays a greater than zero pressure with no BP cuff attached or a value of oxygen saturation with no SpO2 sensor attached.
WARNING: Do not use if device is dropped and/or damaged. Have a qualified service representative check the unit before using again.
WARNING: Do not remove unit covers. Doing so may cause electrical shock to the user. The device does not contain any user serviceable components.
WARNING: Do not immerse the device in any fluid, place fluids on top, or attempt to clean the unit with any liquid detergents, cleaning agents, or solvents. This may cause an electrical hazard. Refer to the cleaning section of this guide for instructions on cleaning. If any of these situations apply, please contact ADC.
WARNING: Remove power before servicing device. Failure to remove power could cause electrical shock or death.
WARNING: A pulse oximeter should NOT be used as an apnea monitor.
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WARNING: Pulse rate measurement is based on the optical detection of a peripheral flow pulse and therefore may not detect certain arrhythmias. The pulse oximeter should not be used as a replacement or substitute for ECG-based arrhythmia analysis.
WARNING: Do not use the device or any of its accessories during magnetic resonance imaging (MRI) scanning. Induced current could potentially cause burns.
WARNING: Tissue damage can be caused by incorrect application or use of an SpO2 sensor, for example by wrapping the sensor too tightly. Inspect the sensor site as directed in the sensor Directions for Use to ensure skin integrity and correct positioning and adhesion of the sensor.
WARNING: Do not use high frequency surgical equipment with the ADView 2 as this may cause loss of stored data
WARNING: No modification of this equipment is allowed.
WARNING: Federal (U.S.) law restricts this device to sale by or on the order of a physician.
CAUTION: A compressed or kinked connection hose may cause continuous cuff pressure resulting in blood flow interference and potentially harmful injury to the patient.
CAUTION: Check calibration of this device annually.
CAUTION: Calibration should be done by a biomedical technician or other authorized personnel.
CAUTION: Never knowingly use a defective device.
CAUTION: Immediately replace parts that are broken, worn, missing, incomplete, damaged or contaminated.
CAUTION: Contact the nearest ADC-approved service center should repair or replacement become necessary. A list
of approved service centers appears in the guide or on our website at www.adctoday.com.
CAUTION: The reliability of the device depends upon conformance with the operation and service instructions, as detailed in this manual.
CAUTION: Only replace battery with same type and model number.
CAUTION: To avoid the risk of electrical shock, this equipment must be only connected to supply mains with
protective earth.
CAUTION: Do not connect the device to equipment that does not meet EN60601-1. When the device is attached to a patient, the device’s communication ports must only be connected to equipment that meets EN60601-1 standard.
CAUTION: Use only ADC-branded cuffs approved for use on the ADView 2 device.
CAUTION: Use only Masimo oximetry sensors for SpO2 measurements with the Masimo SpO2 module. Other oxygen
transducers (sensors) may cause improper performance.
CAUTION: Do not use damaged SpO2 or temperature sensors. Do not use an SpO2 sensor with exposed optical components.
CAUTION: Do not immerse the SpO2 or temperature sensors in water, solvents, or cleaning solutions (the sensors and connectors are not waterproof). Do not sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions in the Sensor Directions for Use.
CAUTION: Do not use damaged patient cables. Do not immerse the patient cables in water, solvents, or cleaning solutions (the patient cable connectors are not waterproof). Do not sterilize by irradiation, steam, or ethylene oxide. See the cleaning instructions in the Patient Cable Directions for Use.
CAUTION: Do not position the device so that it is difficult to access and remove the power cord from the electrical supply. The AC power cord is the means of disconnection to the supply mains.
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Icons, Symbols and Abbreviations
Icons and Symbols
The following icons and symbols are used in this guide, on the ADView 2 equipment, and in packaging.
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Warning message
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Caution message
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Manufacturer
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Manufacture date
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Authorized representative in the European Community
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Catalog number
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Serial number
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Batch or lot code
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Fragile, handle with care
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Keep dry
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Temperature limit
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Humidity limitation
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Consult instructions for use
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Refer to instruction manual/booklet
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Type B
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Type BF applied part. Part is isolated from earth ground.
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Indicates that the device contains materials which may be hazardous to human health.
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CE mark: Product meets the Medical Device Directive and is CE marked to indicate conformance
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SpO2 sensor. Type BF applied part
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USB-A or USB-B
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Warning: Federal (U.S.) law restricts this device to sale by or on the order of a licensed health care practitioner.
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Device includes RF transmitter.
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Indicates the arm circumference which is appropriate for the cuff
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Cuff index marker
93-9005-00 ADView 2 User Manual | 10 September 1, 2016
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Artery marker indicating proper placement – Arrow and symbol should be placed over the brachial artery.
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Cuff range indication
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Device is not made with natural rubber latex
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Device is not made with PVC
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Class II equipment
IPX1!
Protection against vertically falling drops of water
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Expiration date
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Single use only
Commonly Used Abbreviations
BP Blood Pressure
BPM Beats Per Minute
EMR Electronic Medical Record system
K-sounds Korotkoff sounds
MAP Mean Arterial Pressure (Not available in the U.S.)
DIA Diastolic BP
NIBP Non-Invasive Blood Pressure
SpO2 Percent Oxygen Saturation of Arterial Blood (hemoglobin)
SYS Systolic BP
2. Setting Up the ADView 2
Your ADView 2 comes ready to use. The battery and any optional modules purchased were installed prior to shipping.
Unpacking the Monitor
As you unpack your ADView 2, check to make sure you have all the proper components.
Refer to the separate packing label stating which components you received based on the options you ordered with your device.
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Rear Panel Configuration
ADView 2 connections on the back of the device:
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A. AC power cord
B. Wi-Fi USB dongle (optional)
C. Printer or barcode scanner USB cable (optional)
D. Ethernet cable (optional)
E. Mini USB cable to connect to PC or laptop
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Side/Temperature Panel Configuration
Optional modules ordered at the time of original purchase are installed prior to shipping. Modules can also be ordered later and installed in the field. To install the Covidien Filac™ temperature module, use the included Phillips head screwdriver to remove the panel cover on the right side of the unit (the right side when the screen is facing the user). Attach the module and fasten in place. Insert the probe/well assembly into the top of the module.
Side/SpO2 Panel Configuration
Optional modules ordered at the time of original purchase are installed prior to shipping. Modules can also be ordered later and installed in the field. To install an SpO2 module, use the included Phillips head screwdriver to remove the cover on the left side of the unit (the left side when the screen is facing the user). Attach the module and fasten in place.
Filac
93-9005-00 ADView 2 User Manual | 13 September 1, 2016
For ChipOx:
Attach the ChipOx SpO2 sensor to the connector on the module while the retention clip is held upwards. Once the sensor/cable connector is inserted, push the clip downward over the connector to hold it securely in the module. For easy insertion, ensure the cable plug is parallel to the device.
For Masimo:
Attach the Masimo extension cable to the connector on the module, making sure that the connectors lock together. Then, attach the Masimo SpO2 sensor to the other end of the extension cable making sure that the retaining clip is in place.
Install Batteries
The rechargeable lithium-ion battery is installed prior to shipping. Please allow 8 to 12 hours for charging before using your unit. All segments of the Battery Symbol will be lit when the device is fully charged.
CAUTION: Fire, explosion and severe burn hazard. Replace only with ADC part number9005BAT.
If not installed in the device, the battery shall be kept away from heat, fire or other high temperature environments. Keep the battery in a dry place stored at room temperature.
Do not disassemble, attempt to repair or use the battery for any other device or for any other purpose.
Do not place near any metal or use metal to shield the battery from physical damage as this may cause battery overheating and/or a fire risk.
Do not short across the contacts of the battery or attempt to discharge the battery by shorting as a risk of fire or explosion may result.
Do not expose or immerse the battery in water or attempt to clean with any cleaning agents. Only wipe battery with a damp cloth if necessary.
Wash the affected area if electrolyte spills on skin or clothes. Leaking electrolyte may cause discomfort to the skin. If it gets into the eyes, do not rob the eyes. Flush eyes immediately with water, and seek medical attention.
Battery Disposal
The ADView 2 has a lithium-ion battery that contains materials which may be hazardous to human health. Do NOT dispose of battery in domestic waste! Instead, please dispose of in an environmentally responsible way, or return the battery to ADC. A prepaid return label can be obtained. Please see our website for more information.
93-9005-00 ADView 2 User Manual | 14 September 1, 2016
Attach Connections to the Device
After connecting the Power Cable, plug into an available AC power outlet to charge batteries.
Connect the BP cable, SpO2 sensor cable, and temperature sensor (if option is included) to the device.
Connect the barcode scanner and/or printer to the device if these options are included.
Use the Power Button on the left side of the ADView 2 to turn it on.
NOTE: The blue LED around the Selection Knob will be lit whenever the device is powered on.
Mounting Options
The ADView 2 is designed to be used on a tabletop or mounted to a wall or mobile stand. Your device may be delivered with the appropriate mounting kit, depending on the configuration your facility ordered. Please see the separate mounting hardware instructions.
System Configuration
The ADView 2 can be used out of the box with the factory settings.
Changes to the factory settings can be made using the Advanced Configuration Application, which can be accessed by connecting the unit to a Windows computing device. This method can be used to customize certain default settings, like choosing either BP or Spo2 as the pulse rate source. Advanced configuration can also be used by qualified technicians to connect to a network or EMR system.
Please see the separate Advanced Configuration Application guide for more information.
93-9005-00 ADView 2 User Manual | 15 September 1, 2016
3. Getting to Know the ADView 2
Measurement Display
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Patient Identification and Date/Time Stamp
Patient ID
Memory Mode Information
Memory icon
Memory Delete icon
Connections to Ancillary Devices and Networks
Wi-Fi radio on (segments will illuminate in series)
93-9005-00 ADView 2 User Manual | 16 September 1, 2016
Wi-Fi radio connected (segments will be illuminated continuously)
AC power connected
Printer connected and powered on
Barcode scanner connected and powered on
Error Alert Symbol
WARNING: User must take immediate action (see additional information in Section 12)
Battery Level Indicator
Battery symbol (all bars illuminated indicate a full charge)
Blood Pressure Measurement Mode Selection Icons
Manual Mode (for auscultatory readings)
Averaging Mode
Number of measurements taken in averaging mode
Maximum pressure setting for Manual Mode
Time before first measurement in minutes (Illuminates when Averaging Mode is selected)
Time between measurements in seconds (Illuminates when Averaging Mode is selected)
Blood Pressure Results (DIA and SYS)
DIA and mmHg: Diastolic blood pressure
SYS and mmHg: Systolic blood pressure
EMR Transmission Icons
EMR icon prompts the user to confirm whether or not to send measurement data as message to EMR
system. (Only shown if EMR connectivity has been set up via Configuration Application.)
Message icon (Indicates if EMR messaging is successful)
If successful, the icon will flash on and off with check mark.
If not successful, it will flash on and off with X.
Adult or Child Patient Selection
Press and hold toggle button for 4 seconds, until selection knob starts flashing. Release toggle button, and use the selection knob to select the icon needed. Selected icon will blink after 1 second. Press the selection knob to confirm the selection.
Adult BP Mode icon. This icon is illuminated when the Adult BP mode is selected. The ADView 2 will remain in the
selected patient mode until a new mode is set.
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