ADC ADView 2 9005BPSTO User Manual Download Page 30 | Manualshive

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ADC ADView 2 9005BPSTO User Manual Download Page 30

ADView 2 User Manual | 30

93-9005-00

rev 4

September 1, 2016

The tested device meets the stated accuracy specification of RMS Error = 2.00% for the range 70% to 100% SaO

2

. The

accuracy is not specifed below 70% SaO

2

. In addition, here are detailed measured A

RMS

values over the specified

discreet ranges:

Range

A

RMS

90-100%

0.60%

80-90%

0.54%

70-80%

0.67%

Special Notes for ChipOx SpO

2

module:

NOTE: Use only SpO2 sensors from ADC approved for use on the ADView 2 ChipOx SpO2 module.

NOTE: A functional tester cannot be used to assess the accuracy of a ChipOx pulse oximeter sensor or pulse
oximeter. Using FLUKE Biomedical Index 2 SpO

2

simulator, the device can display the entire range of SpO

2

values.

ChipOx Sensors:

Before using, carefully read the ChipOx sensor directions for use, which includes cleaning and disinfection
instructions.
ChipOx sensors are provided non-sterile.

ChipOx Graphical Plot:

Below is a graphical plot of discreet A

RMS

values measured with ChipOx Oximetry in a clinical study using ChipOx

pulse oximetry sensors:

«
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28
29
30
31
32
...
»

Summary of Contents for ADView 2 9005BPSTO

Page 1: ...ADC ADView 2 Modular Diagnostic Station User Manual 2 2 TM ...

Page 2: ...ADView 2 User Manual 2 93 9005 00 rev 4 September 1 2016 ...

Page 3: ...vided 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 ...

Page 4: ...nt 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...

Page 5: ...asurement 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 Axi...

Page 6: ...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...

Page 7: ... 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...

Page 8: ...e 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...

Page 9: ...ture limit Humidity limitation Consult instructions for use Refer to instruction manual booklet Type B Type BF applied part Part is isolated from earth ground Indicates that the device contains materials which may be hazardous to human health CE mark Product meets the Medical Device Directive and is CE marked to indicate conformance SpO2 sensor Type BF applied part USB A or USB B Warning Federal U...

Page 10: ... 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 Unpackin...

Page 11: ...ember 1 2016 Rear Panel Configuration ADView 2 connections on the back of the device 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 ...

Page 12: ...n 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 P...

Page 13: ...eat 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...

Page 14: ...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 wh...

Page 15: ...6 3 Getting to Know the ADView 2 Measurement Display 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 ...

Page 16: ...ging 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 successfu...

Page 17: ...art rate display MAP Measured in mmHg Illuminated when MAP functionality is enabled and a MAP value is shown NOTE This is a factory setting MAP is not available in the U S Pulse Oximetry Measurement Display Expressed in of arterial oxyhemoglobin Temperature Measurement Settings and Results Display Body temperature in either Fahrenheit or Celsius user selectable Cold Mode Predictive Mode Direct Mod...

Page 18: ...n be used to change parameters and to set the intended parameter Start Stop Button Press this button to start or stop a BP measurement Home Button Pressing this button returns you to the single measurement mode Monitor Setup Press the power button to start Initial Power up The display will gradually illuminate over a 3 second period If this is the first time the device has been turned on since it ...

Page 19: ...hen you press the power button when the device is powered up During power down all LCD segments and icons illuminate for 1 second and then the entire display gradually darkens from normal brightness to black and then one beep sounds At this point the device enters Sleep Mode a low power state and is considered off Automatic Power down occurs when the device has not been used i e no measurements ta...

Page 20: ... sending to the EMR Press the Memory Button While the EMR and Check Icons are flashing turn the Selection Knob until the X icon is displayed and then press the Selection Knob The measurements will be saved to the device memory only Without EMR Connectivity The ADView 2 does not have to be connected to an EMR system to save measurements You can save them to the device s own memory With the patient ...

Page 21: ... arm should be fully supported and resting at heart level Encourage the patient to relax and to be still and quiet Select and position BP cuff Selecting the wrong size cuff will produce an inaccurate blood pressure measurement When wrapped around the patient s arm the Cuff Index Line should fall within the Range Markers printed on the cuff If not select a larger or smaller cuff to ensure optimal B...

Page 22: ...Note Use of Manual Mode may be required to meet certain clinical trial protocols It also can be used to verify a BP reading if the automated BP results diverge significantly from a patient s prior history or if you as the clinician deem it necessary Manual Mode mimics a traditional sphygmomanometer and does not measure Systolic or Diastolic blood pressure Note Averaging Measurement Mode can only b...

Page 23: ...Averaging Measurement Mode setup screen with default values You can select 2 to 5 measurements to average In this example 4 measurements are set to be averaged On left is Time Before First Reading will start Select 0 5 min Default 0 On right is Time Between Measurements Select 15 120 sec Default 15 sec Note In averaging mode you are unable to see individual readings Averaged Results will be displa...

Page 24: ...s Start Stop Button Inflate deflate cycle proceeds automatically until results are displayed A long beep will sound to indicate measurement is complete When selecting this mode the will flash to allow the user to decide how many reading they would like averaged Select number of readings by rotating the Selection Knob and then pushing the knob in The minute number will flash and the user can select...

Page 25: ...lity s preferred process To send results to an EMR or to the device memory follow the steps in Section 4 Step 6 Prepare for New Patient After all measurements have been recorded or captured remove the cuff from the patient and clean it according to your facility s requirements This disinfecting and storage step applies to BP cuffs as well as other optional accessories whose use will be covered in ...

Page 26: ...reported as oxygen saturation level WARNING Pulse oximeter probes and sensors are designed for use with specific pulse oximeter devices Only use probes and extension adapter cables that are specified for each SpO2 module WARNING The responsible organization and or operator must verify the compatibility of the oximeter oximeter probe and extension adapter cable before use Otherwise patient injury c...

Page 27: ...f actual arterial oxygen saturation Therefore assure proper venous outflow from monitored site Sensor should not be below heart level e g sensor on hand of a patient in a bed with arm dangling to the floor CAUTION Venous pulsations may cause erroneous low readings e g tricuspid value regurgitation CAUTION The pulsations from intra aortic balloon support can be additive to the pulse rate on the oxi...

Page 28: ...rops below 90 no measurement will be displayed in the SpO2 section and the percent symbol will begin flashing Check sensor for correct placement and usage Special Notes for Masimo SET SpO2 Module NOTE Possession or purchase of this device does not convey any express or implied license to use the device with unauthorized sensors or cables which would alone or in combination with this device fall wi...

Page 29: ... correspond to SpO2 values between 1 and 100 and generates an N value for each of these R values The S 660 and S 905 signals are processed with each possible N noise reference through an adaptive correlation canceler ACC which yields an output power for each possible value of R i e each possible SpO2 from 1 to 100 The result is a Discrete Saturation Transform DST plot of relative output power vers...

Page 30: ...m ADC approved for use on the ADView 2 ChipOx SpO2 module NOTE A functional tester cannot be used to assess the accuracy of a ChipOx pulse oximeter sensor or pulse oximeter Using FLUKE Biomedical Index 2 SpO2 simulator the device can display the entire range of SpO2 values ChipOx Sensors Before using carefully read the ChipOx sensor directions for use which includes cleaning and disinfection instr...

Page 31: ...d device meets the stated accuracy specification of RMS Error 1 89 for the range 70 to 100 SaO2 The accuracy is not specifed below 70 SaO2 In addition here are detailed measured ARMS values over the specified discreet ranges Range ARMS 90 100 1 54 80 90 2 10 70 80 2 56 ...

Page 32: ...d cause measurement inaccuracies NOTE To change between Celsius and Fahrenheit press the C F button on the temperature module Press again as needed NOTE After removing the probe from the isolation chamber the Install Remove Probe Cover icon will flash to remind you to apply a new probe cover A new probe cover must be applied in order to take a measurement After you withdraw the probe from the isol...

Page 33: ... the normal range the thermometer will automatically switch into its standard predictive mode in order to provide a more accurate reading Quick Mode is indicated by a rabbit icon on the display Quick Mode is not available when in Cold Mode or in Direct Mode The thermometer normally operates in predictive mode to provide fast and accurate temperature measurements However in instances when no measur...

Page 34: ...evice memory Press the Memory Button on the front of the device to save results to memory The Memory Icon Check Mark icon and all values that are displayed on the screen at the time the button is pressed will flash before the results are saved The following values can be saved to memory Parameter Name Field Type Patient ID Alphanumeric Text Time Stamp Numeric HH MM SS Date Stamp Numeric MM DD YYYY...

Page 35: ...The Memory Delete icon and Check icon will flash in sync with the Selection Knob All other values on the screen will be blank Press the Selection Knob again to delete all measurements or rotate the knob clockwise until the X icon flashes and press the Selection Knob to cancel the deletion EMR Transmissions Section 4 covers the basics of sending measurements to EMR Here are more details Validating ...

Page 36: ...asurements at intervals set during EMR setup If problems persist you may wish to contact your facility s information technology department As a backup the patient s measurements are saved in the device memory when the memory button was pressed and can be retrieved using the procedure detailed in the beginning of Section 9 Note After the memory button is pressed all values to be stored to memory wi...

Page 37: ...pose 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 Product Disposal 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 E...

Page 38: ...05TR Temperature Module Rectal 9005S SpO2 ChipOx Module 9005SM SpO2 Masimo Module Mounting Platforms Part Number Description 9005D Desktop Caddy 9005W Wall Mount with Basket 9005M Mobile Stand with Basket 9005PSHELF Printer Shelf for Mobile Stand Base unit is self standing Add the optional Desk Caddy to keep cuffs and cords organized Blood Pressure Cuffs Part Number Description 9005 9CGR 1MB Child...

Page 39: ...U AC Power Cord Europe 9000PCUK AC Power Cord U K 9000PCAU AC Power Cord Australia Temperature Accessories Part Number Description 9000TP Thermometer Probe Covers 20 Box 25 Boxes Case 9000TP 5000 Thermometer Probe Covers 5000 Case 9000TOP Oral Axillary Temperature Probe 9005TWB Oral Axillary Temperature Well 9005TOK Oral Axillary Temperature Kit Probe Well Probe Covers 9000TRP Rectal Temperature P...

Page 40: ...rement display result and code Below are common error codes Take action as directed on the screen or as suggested in the table below Status Messages Code Displayed Action User Should Take Blood Pressure 1 2 4 87 88 Check that the cuff is in the correct position Check that the cuff is properly tightened and that the tubing is properly connected Check that there is no excessive clothing between the ...

Page 41: ...ff and repower on the ADView 2 Retry reading If issue persists call customer service 520 524 526 Power off and repower on the ADView 2 Retry reading If issue persists replace the probe Retry reading If issue persists replace module or call Customer Service 530 Use in normal room temperature environment suitable to the device SpO2 121 124 133 136 150 156 Remove sensor from the patient and ensure pr...

Page 42: ...r and power off and repower on the ADView 2 Replace battery 212 214 Call Customer Service 215 Charge battery Barcode Scanner 701 706 Check and ensure proper barcode and patient ID was scanned Rescan patient ID Disconnect and reconnect cable from USB port on ADView 2 Replace barcode scanner Printing 381 Close printer door 382 Replace paper 383 387 388 390 Check cables Reset printer Replace printer ...

Page 43: ...Y 11788 Tel 1 800 ADC 2670 1 631 273 9600 Fax 1 631 273 9659 Email customerservice adctoday com Web www adctoday com 13 Frequently Asked Questions What is the expected battery life for the ADView 2 When batteries are fully charged the ADView 2 is designed to run on internal battery power for 200 measurement cycles BP temperature and SpO2 measurements before requiring recharge When only the bottom ...

Page 44: ...easurement 99 After all results are cleared from the memory the Memory Location Identifier also will return to 01 14 Technical Information EMC Statement This equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document This equipment has been tested and found to comply with the limits for medical devices...

Page 45: ...ctuations flicker emissions IEC 61000 3 3 Complies Guidance and manufacturer s declaration electromagnetic immunity The ADView 2 is intended for use in the electromagnetic environment specified below The customer or the user of the ADView 2 should assure that it is used in such an environment When the product is in an environment with static the product may show error SpO2 reading it will recover ...

Page 46: ... characteristic of a typical location in a typical commercial or hospital environment NOTE UT is the A C mains voltage prior to application of the test level In the event of an error the device will auto recover within 5 seconds Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 kHz to 80 MHz 3 V ...

Page 47: ...cable RF compliance level above the ADView 2 should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the ADView 2 b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Recommended separation distances between portable and mobile RF communications equipment and the ADVi...

Page 48: ...ply Input 100 240 VAC 1 5A max 50 60 Hz Output 9VDC 5A IEC 320 type input connector Calibration The accuracy of cuff pressure transducers indicators should be verified bi annually Safety Systems Independent hardware over pressure circuit and redundant software overpressure algorithm to limit cuff pressure to less than 300 mmHg 20 10mmHg Independent hardware timing circuit and redundant software ti...

Page 49: ...t motion trembling and shivering Specifications SP02 Sensor Function ChipOx Masimo M LNCS DCI Saturation Normal no motion 2 70 100 Arms 2 70 100 Arms Saturation Motion N A 3 70 100 Arms Low Perfusion N A SpO2 2 Pulse Heart rate 20 300 BPM 3 BPM 3 BPM Pulse Heart rate w motion 20 300 BPM 3 BPM 5 BPM Wavelength Output Power RED 660nm 3 5 4 5mW IR 905nm 3 5 4 5mW RED 660nm 15mW IR 905nm 15mW For more...

Page 50: ...od of this limited warranty Should a defect become apparent the original purchaser should first notify ADC of the suspected defect The device should be carefully packaged and shipped prepaid to American Diagnostic Corporation 55 Commerce Drive Hauppauge NY 11788 Tel 1 800 ADC 2670 1 631 273 9600 Fax 1 631 273 9659 The device will be repaired in the shortest possible time and returned prepaid by th...

Page 51: ...red for American Diagnostic Corporation 55 Commerce Drive Hauppauge NY 11788 U S A by Suntech Medical Morrisville NC 27570 Suntech Medical Ltd Oakfield Industrial Estate Eynsham Oxfordshire 0X29 4TS UK Assembled in U S A Made in China 93 9005 00 rev 4 ...

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