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1. A i Source pO2 _J opm J gt Maso SET B A V FIGURE 1 1 Front Panel 1 Digital Display The Duo digital display features parameter tiles numeric LEDs and LED indicators 0070 10 0603 0 1 Duo M Operating Instructions General Product Description Controls and Indicators Parameter Tiles The parameter tiles shown in FIGURE 1 2 display the readings for the monitored parameters and also display information codes and error codes When there is no measurement being determined and no code condition exists for a particular parameter its associated tile will be blank FIGURE 1 2 Parameter Tiles a NIBP e The NIBP parameter tile is separated into three areas that are labeled as Sys systolic Dia diastolic and MAP mean arterial pressure The LEDs are red e The labels for the unit of measure are mmHg or kPa b Pulse Rate e The Pulse Rate parameter tile is labeled with a heart symbol Q The LEDs are red e The dual source labels are NIBP red LED and SpO green LED e The label for the unit of measure is bpm c SpO3 Optional e The SpO parameter tile is labeled SpO The LEDs are green e The label for the unit of measure is
2. Theory of Operation Patient Connectors Fan i Driver SpO Module NIBP Module Isolated SpO Power Supply Power Supply Keypad Switches CPU Display pcb Lithium Ion External RS232 a Serial os Battery Interface Inverter Interface FIGURE 1 1 Interconnection Block diagram The Isolated SpO Power Supply is present with optional Masimo and Nellcor SpO ONLY The RS232 TTL Inverter and Serial Interface Connector is used for software updates by Service Power Supply Board Overview The AC DC converter transforms the AC input voltage 90 264 vac 50 60 Hz to a DC voltage used to charge the internal Lithium lon battery and supply power to the 12 vdc and 3 3 vdc DC DC converters The battery charging circuit will actively charge the battery while the Duo is connected to an AC source Battery charging takes place whether the monitor is on off or in use The power supply will automatically switch to the internal battery if an AC source is not present NOTE The power supply board MUST be connected to a resistive load to operate properly and to avoid damage due to an over current condition AC Input AC DC Converter gt 4 x i Battery and Charging Management Circuit 0070 10 0604 01 Power ON OFF Control Circuit 3 3v DC DC Converter 12v DC DC Converter
3. FIGURE 2 2 Lithium lon Battery e Ensure that the locking mechanism engages over the end of the battery by pressing the battery firmly into the compartment e Replace the battery compartment door Duo Operating Instructions 0070 10 0603 01 2 3 Initial Set Up 2 2 1 Operation NOTE The Lithium lon battery is shipped in a partially charged state and must be fully charged prior to its first use 3 Charge the Lithium lon battery as follows e Connect the AC power cord to the AC receptacle located on the rear panel e Plug the opposite end of the AC power cord into the appropriate AC outlet The Battery Charging indicator will be illuminated on the front panel e Allow the battery to charge for a minimum of 4 hours NOTE Optimum battery runtime is achieved after 3 charge discharge cycles 4 Power ON the Duo by pressing the Power ON OFF key A single beep tone indicates that the Duo has successfully powered ON An internal diagnostic test and an LED test are then executed For the duration of the tests all operational LEDs are displayed and the number 8 plus any decimal LEDs is displayed in the parameter tiles When the tests are successfully complete the following LEDs remain displayed e AC Power indicator if AC power is present e Battery Charging indicator if the battery is installed and AC power is present e Patient Size indicator the current setting e Unit of Measure indicators the most recent settin
4. Some codes refer to a particular parameter function and are displayed in the associated parameter tile NIBP codes are displayed in the Sys section of the NIBP parameter tile Information codes referring to the general operational status of the monitor and not to a specific parameter are displayed in the Information Codes tile All codes display until the condition is removed or for one time error codes until the Clear Next Patient key is pressed If multiple codes exist simultaneously then each code will cycle through and display for a duration of 1 second Information codes and error codes listed in the following table can generally be resolved by the user However some error codes may require resolution by a qualified service technician NOTE Information codes and Error codes that are marked with an asterisk are one time codes that can be cleared from the display by pressing the Clear Next Patient key Duo Operating Instructions 0070 10 0603 01 2 13 Information Codes and Error Codes 2 4 1 Information Codes MESSAGE TYPE NIBP MASIMO SPO2 CODE EO3 E06 E07 E08 E09 E10 E13 E20 E21 E22 E23 E28 E29 E34 DESCRIPTION LOOSE CUFF SUCCESSFUL PNEUMATIC TEST PNEUMATIC TEST FAIL PNEUMATIC LEAK WEAK SIGNAL RANGE EXCEEDED EXCESSIVE MOTION SIGNAL SATURATED OVER PRESSURE NIBP TIME OUT SPO2 INTERFERENCE SPO2 LOW PERFUSION SPO2 TOO MUCH LIGHT
5. d Information Codes e Information and error codes are displayed in the window e See section 2 4 1 for additional information Duo Operating Instructions 0070 10 0603 01 1 3 Controls and Indicators General Product Description LED Indicators LED indicators shown in FIGURE 1 3 illuminate green and are used to indicate the current status of the following Battery Charging AC Power Patient Size and the NIBP function FIGURE 1 3 LED Indicators a Battery Charging If a battery is installed and AC power is being supplied to the monitor the battery charging LED will illuminate to indicate that the battery is charging The battery charging LED will illuminate regardless of whether the Duo is OFF or in normal monitoring mode If a low battery condition exists the battery charging LED will flash When the LED begins flashing the approximate remaining battery runtime is 10 20 minutes for the maximum load configuration of NIBP SpO5 b AC Power IF AC power is being supplied to the monitor the AC power LED will illuminate The AC power LED will illuminate regardless of whether the Duo is OFF or in normal monitoring mode c Patient Size The selected patient size LED will illuminate when the Duo is in normal monitoring mode In FIGURE 1 3 the Adult patient size LED is illuminated d NIBP Start Stop If the Duo is in normal monitoring mode and an NIBP measurement is in progress the NIBP start stop LED will
6. Duo Service Manual Theory of Operation Duo Service Manual Hardware Overview FIGURE 1 2 Power Supply Block Diagram Power Supply Voltage Test Points Location Measure across C5 C5 Negative Lead Measure across Q1 pin and C5 Negative Lead Measure across C12 C12 Negative Lead C47 Positive Lead C50 Positive Lead C68 Positive Lead Function Primary Rectified Voltage DC Range 105 374 volts Primary Ground 110k Hz Drive frequency 10 5 vdc input for Fan Driver board Secondary Ground 5 vdc supply for Power On Off Control 3 3 vdc output 12 vdc output 0070 10 0604 01 1 3 Hardware Overview 1 2 2 1 2 3 Theory of Operation Fan Driver Board Overview The Fan Drive Board is active during the battery charging cycle The Temperature Detector senses the temperature of the heat sink of the Secondary Rectifier diode and turns on the fan when the heat sink reaches a certain temperature Temperature Detector DC Fan Driver a gt Fan Input Circuit FIGURE 1 3 Fan Driver Block Diagram Fan Driver Board Test Points Location Function Measure across C202 5 vdc Fan power C202 Negative Lead Ground Measure between Q202 pinl and Ground Drive frequency when the Fan is activated CPU Display Board Overview The CPU Display board controls the SpO9 Module and NIBP Module through communications via UART devices The CPU Board receives user com
7. Operation Service Manual Datascope Duo mindray Duo mindray NORTH AMERICA Operating Instructions Datascope Duo NORTH AMERICA Duo is a US trademark of Mindray DS USA Inc Navigator is a U S trademark of Mindray DS USA Inc Masimo SETS LNOP and CleanShield are U S registered trademarks of Masimo Corp Nellcor and OxiMax are U S registered trademarks of Nellcor Puritan Bennett Inc Copyright Mindray DS USA Inc 2008 All rights reserved Contents of this publication may not be reproduced in any form without permission of Mindray DS USA Inc 0070 10 0603 0 1 Duo Operating Instructions Table of Contents OFS Ola ao PON iii WeirninGS Precautions And INOS Sacks kai aa ia at ak i a isla dle iii Namibia ad dadi lin id ys akon Aan ai nacht Aa Daddies rai iv A Een Oe EO ey ee Vv NOTE S eisi ass aa aa a a a i SIRO IO OOO viii e A II viii A A reat eect Rt ene br tutte EERE EMEA CCE ida iii ei ili ele ei viii SYDE tact sae anh i a a ai si N a A a a a a a a A S S eral ix General Product Des criDHONi as siss ss sssks s ssis kssosano sans sese sena sks n s usasssnos ss I k nikossdsa das ss ss ssusssssseds b I Venice lidia 1 1 COnrolsandincicalo itinerari etico 1 2 Front Panel 05 na asl lilla D a ahs date lieti ella 1 2 Repaci a 1 7 A o I a a T i Gasca a a a aaa 1 8 ODGFGNON ces dis sias ski ski isvis a e iai ia e ii a ij ai A a a i a la a a E o as a ii I Moaes or Operaio Yas
8. e significant levels of dysfunctional hemoglobins e g carboxyhemoglobin or methemoglobin e intra vascular dyes such as indocyanine green or methylene blue e exposure to excessive illumination such as surgical lamps especially ones with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or excessive ambient light In such cases cover the sensor site with opaque material e excessive patient movement e venous pulsations e electro surgical interference e placement of a sensor on an extremity that has a blood pressure cuff arterial catheter or intra vascular line e nail polish or fungus In certain situations in which perfusion and signal strength are low such as in patients with thick or pigmented skin inaccurately low SpO2 readings will result Verification of oxygenation should be made especially in patients with chronic lung disease before instituting any therapy or intervention Many patients suffer from poor peripheral perfusion due to hypothermia hypovolemia severe vasoconstriction reduced cardiac output etc These symptoms may cause a loss in vital sign readings If the SpO2 sensor or patient cable are damaged in any way discontinue use immediately To prevent damage do not soak or immerse the sensor in any liquid solution Do not attempt to sterilize When applying the SpO2 sensor to the patient ensure proper positioning alignment and skin integrity Exercise extreme
9. whichever is greater for heart rate 0070 10 0604 0 1 Duo Service Manual Calibration and Performance Verification NIBP Calibration NOTE The actual measured values displayed on the Duo monitor may not compare with the selected target pressure on the simulator This test is intended to confirm the REPEATABILITY not accuracy of dynamic NIBP readings Accuracy can only be confirmed by performing the NIBP Calibration outlined in section 2 6 of this manual Duo Service Manual 0070 10 0604 01 27 SpO gt Verification Calibration and Performance Verification 2 7 SpO Verification 2 1 Test Eguipment e SpO5 simulator 212 Test Procedure 1 Connect the appropriate SpO probe connector to the Duo monitor 2 Connect the SpO probe to the SpO5 simulator 3 Set the simulator target values to SpO 98 Pulse Rate 70 4 Verify that the displayed SpO and pulse rate values on the Duo monitor are 2 of the simulator target values 5 Change the simulator values 6 Verify the displayed values on the Duo monitor are equal to the simulator values 2 2 8 0070 10 0604 0 1 Duo Service Manual 30 Paris 3 1 Introduction This section contains exploded views of the Duo monitor internal modules and parts list Duo Service Manual 0070 10 0604 0 1 Introduction Parts SpO Module See SpO Detail FIGURE 3 1 Duo Exploded View 322 0070 10 0604 0 1 Duo Service Manual Parts Introd
10. 17 5 hours with continuous SpO measurement and no NIBP measurements being taken The Battery Charge Time 4 5 hours maximum 0070 10 0603 01 Duo Operating Instructions Appendix 5 2 11 5 2 11 1 5 2 11 2 5 2 12 5 2 13 Patient Parameter Specifications Physical Characteristics Maximum Size 130 mm maximum width 243 mm maximum height 140 mm maximum depth Maximum Weight 1770 grams 3 9 pounds maximum without optional accessories 2088 grams 4 6 pounds maximum with 1 Lithium ion battery without optional accessories Cooling Fan The cooling fan operates when the Duo is running on AC power only and the internal temperature exceeds a pre determined value The fan does not operate when the Duo is running on battery power Environmental and Safety Characteristics Storage Temperature 20 C to 60 C Operating Temperature 5 C to 40 C Storage Humidity 10 to 95 non condensing Operating Humidity 15 to 95 non condensing Storage Altitude 1000 to 20 000 feet ASL 1050 hPa to 466 hPa 788 mmHg to 349 mmHg Operating Altitude 1000 to 9 889 feet ASL 1050 hPa to 700 hPa 788 mmHg to 525 mmHg Shipping The monitor meets the requirements of ISTA shipping procedure 1A for containerized product when packed in designated packaging Shock The monitor remains operational within specification after exposure to 15 g 11 msec half sine shock pulse tested per IEC 60068 2 27
11. 3 digits OXI P 1 Below 70 unspecified MAX R D YSE and D YSPD 70 to 100 3 5 digits Below 70 unspecified Pulse Rate Resolution 1 bpm Update Rate 1 Hz Range and Accuracy RANGE ACCURACY 20 to 250 bpm 3 bpm 251 to 300 bpm Unspecified NOTE The sensor measurement wavelengths are nominally 660 nm for the red LED and 890 nm for the infrared LED Maximum optical power output for LED is 4 mW Duo Operating Instructions 0070 10 0603 01 5 9 Patient Parameter Specifications Appendix 5 2 8 5 2 8 1 5 2 9 5 2 10 5 2 10 1 Power Supply Power Source The Duo monitor auto selects its power source from those available The monitor uses the following priority in choosing the power source 1 AC Mains Power 2 Internal battery power The monitor operates from AC Mains power with or without the internal batteries installed AC Mains Power Source Input Voltage 100 240 VAC 10 Line Frequency 50 60 Hz 3 Hz Current 0 7 0 4 Amps Battery Power Time to Shutdown from Low gt 10 minutes but lt 20 minutes after indication with Battery 1 new fully charged battery Lithium Ion Battery P N 0146 00 0079 The battery pack is 7 2 VDC 6 6 Amp hr The minimum Battery Run Time 14 0 hours from one fully charged new battery at 25 C with continuous SpO measurement and NIBP measurements taken at 7 minute intervals 17 0 hours with NIBP only and measurements taken at 7 minute intervals
12. SPO2 UNRECOGNIZED SENSOR SPO2 TIMEOUT SPO2 LOW SIGNAL IQ PR EXCEED 0070 10 0603 0 1 Operation REASON Cuff is not properly wrapped or no cuff is present Indicates NIBP pneumatic test was successful During pneumatic test leak is detected Cuff is too loose or patient pulse is too weak NIBP value exceeds the upper measurement limit Monitor is detecting too much motion and or noise to obtain a reading Pressure has exceeded the specified upper safety limit Measuring time has exceeded 120 seconds adult pediatric Noise detected on the pulse signal prevents pulse discrimination Patient perfusion is low There is too much ambient room light for the sensor to function properly The sensor is not recognized by the monitor SpO2 has exceeded its maximum continuous measuring period of 2 minutes The SpO2 data has been removed from the display Quality of signal is poor PR value exceeds the measurement range Duo Operating Instructions Operation MESSAGE TYPE NELLCOR SPO2 GENERAL TECHNICAL Duo Operating Instructions CODE E40 E4 E43 E44 E46 E47 E34 E501 DESCRIPTION SPO2 INTERFERENCE SPO2 CHECK SENSOR SPO2 WEAK PULSE SPO2 WEAK SIGNAL SPO2 MOTION SPO2 TIMEOUT PR EXCEED BAT VOLTAGE LOW 0070 10 0603 01 Information Codes and Error Codes REASON Noise is detected on the pulse signal preventing pulse discrimination from
13. The message is removed when No Pulse status is detected or when motion ceases SpO gt data has been determined continuously for more than 2 minutes so SpO data has timed out from the display Battery voltage is low Error with front panel keypad board Monitor cannot be turned off normally Monitor cannot communicate with SoO module during self test Troubleshooting Guide Monitor Failures MESSAGE PROBLEM No display after power on power indicator does not light NIBP or SpO will not function REASON Bad line fuse Bad power supply Bad CPU Display board CPU Display board or module failure 0070 10 0604 01 Repair Information SOLUTION Replace fuse Replace power supply Replace CPU Display board Isolate and replace defective board module Duo Service Manual Repair Information Duo Service Manual Module Failures MESSAGE PROBLEM NIBP cuff cannot be inflated Intermittently won t take an NIBP reading NIBP readings inappropriately high or low for patient condition No SpO reading SpO value is inaccurate REASON Pinched or leaking hose or cuff Loose cuff or patient movement Incorrect cuff size Incorrectly applied cuff NIBP module is out of calibration SpO sensor or cable damaged or disconnected Sensor not on patient SpO sensor or cable damaged or disconnected Sensor not on patient Coloring agent dye has been inje
14. 2 NIBP Start Pressure Settings and Ranges The Start Pressure is adjustable and is set to the following defaults PRESSURE INCREMENT PATIENT SIZE DEPENDING ON ALGORITHM DEFAULT START PRESSURE Adult Mode 30 60 mmHg 178 5 mmHg Pediatric Mode 30 60 mmHg 133 5 mmHg NIBP Measurement Cycle There is one mode of measurement operation manual The manual mode requires the operator to initiate the measurement cycle In the manual mode the unit adjusts the inflation pressure according to the previous systolic pressure After the first successful measurement is made the subsequent inflation pressure becomes 50 10 mmHg above the previous systolic pressure measurement SpO Performance Requirements The Duo monitor is capable of providing SpO functional saturation level measurements via an OEM Masimo MS 7 pulse oximeter or an OEM Nellcor MP 506 pulse oximeter SpO Agency Requirements The SpO5 function performs in accordance with the requirements of EN 865 1997 Masimo SpO Performance Requirements The Masimo MS 7 pulse oximeter with SET technology is implemented SPO Sensor Compatibility Compatible with LNOP Series sensors Display Range 1 100 Resolution 1 0070 10 0603 0 1 Duo Operating Instructions Accuracy No motion conditions During motion conditions Response Time Patient Parameter Specifications PATIENT SIZE SATURATION RANGE 70 to 100 0 69 Adult Mode 2 digits unspecified Ped
15. S N Foot Power Switch Plunger Clear Switch Plunger Patient Size Switch Plunger Start NIBP Switch Plunger Duo Service Manual Parts Duo Service Manual REF NUMBER 38 39 40 41 N S N S N S Not Shown Display Overlay LANGUAGE OPTION English NIBP Only English NIBP SpO gt Upper Rear Label LANGUAGE English Connector Label DESCRIPTION No SpO Masimo SpO Nellcor SpO PART NUMBER 0330 00 0052 0103 00 04 1 1 0386 00 0309 See table below See table below See table below PART NUMBER 0334 00 1641 01 PART NUMBER 0334 00 1602 01 0334 00 1602 02 0334 00 1602 04 0070 10 0604 01 Parts Listing DESCRIPTION Keypad Overlay Pneumatic Fitting Mounting Plate Rear Label Upper Display Overlay Connector Label PART NUMBER 0330 00 0053 01 0330 00 0053 1 1 Parts Listing Parts This page intentionally left blank Sef2 0070 10 0604 0 1 Duo Service Manual in Repair Information 4 1 Introduction This chapter of the Duo Service Manual provides the necessary technical information needed to perform repairs on the instrument The most important prerequisites for effective troubleshooting are a thorough understanding of the instrument functions as well as an understanding of the theory of operation Masimo J3 SpOo2 Jl Module P2 To P1 on Mai
16. Vibration The monitor remains operational within specification after exposure to the following Sinusoidal and Random Vibration Reference FDA Reviewer Guidance for Pre market Notification Submission November 1993 draft Duo Operating Instructions 0070 10 0603 01 5 11 Patient Parameter Specifications Sinusoidal Vibration Random Vibration Drop Impact Appendix Per IEC 60068 2 6 1 g or 0 07 mm 57 62 Hz crossover frequency 10 to 500 Hz 10 sweep cycles in each axis Per IEC 60068 2 34 0 02 g2 Hz 20 500 Hz Low degree of reproducibility 9 minutes per axis The monitor meets the requirements specified by ECRI PB 296 892 section Alll 3 3 for Class 3 devices The monitor meet the requirements specified by ECRI PB 296892 section Alll 3 2 for Class 3 devices 0070 10 0603 0 1 Duo Operating Instructions Appendix Electromagnetic Compatibility e The Duo meets the requirements of IEC 60601 1 2 2001 EN 60601 1 2 2001 Patient Parameter Specifications NOTE The Duo needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided below NOTE Portable and mobile RF communications equipment can affect the Duo See TABLE 5 1 through TABLE 5 4 TABLE 5 1 GUIDANCE AND DECLARATION ELECTROMAGNETIC EMISSIONS The Duo is intended for use in the electromagnetic environment specified below The customer or the user of the Duo should
17. applying supplemental tape failing to inspect the sensor site periodically or failing to position appropriately Carefully read the SpO sensor directions and all precautionary information before use Excessive ambient light may cause inaccurate SpO measurements In such cases cover the sensor site with opaque material The cuff must be properly applied to the patient s limb before inflating If it is inflated without being securely wrapped damage to the cuff can result This product contains natural rubber latex which may cause allergic reactions This refers specifically to the large adult gray blood pressure cuff 0998 00 0003 35 If the device is accidently saturated with any liquid immediately discontinue use and contact service personnel 0070 10 0603 01 V Introduction CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION vi Precautions Inaccurate SpO measurements may be caused by e incorrect sensor application or use e significant levels of dysfunctional hemoglobins e g carboxyhemoglobin or methemoglobin e intra vascular dyes such as indocyanine green or methylene blue e exposure to excessive illumination such as surgical lamps especially ones with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps or excessive ambient light In such cases cover the sensor site with opaque material e excessive patient movement e venous p
18. carefully remove dust and dirt particles with a fine soft hair brush or a soft sponge moistened with cleaning solution Fingerprints and stains may be removed by using a liquid lens cleaner and a soft cloth DO NOT wipe a dry screen or use alcohol or a solvent containing chlorinated hydrocarbon Care and Cleaning of Accessories SpO Sensors NOTE Refer to the individual instruction sheets that are packaged with each sensor 1 Inspect the sensors and cables for damage on a daily basis Replace as necessary 2 Clean reusable sensors before and after each use as follows e Wipe the patient contact area using a soft cloth with a mild soap and water solution or isopropyl alcohol Hydrogen peroxide can be used to remove dried blood from all accessible surfaces e Clean the cable with a 3 hydrogen peroxide solution isopropanol solution or other active reagent Do not subject the connector of the sensor to such a solution e Allow the sensor to completely dry before using CAUTION When cleaning SpO2 sensors do not use an excessive amount of liquid Wipe the sensor surface with a soft cloth dampened with a cleaning solution CAUTION Do not subject the SpO2 sensor to autoclaving CAUTION If the SpO2 sensor or patient cable are damaged in any way discontinue use immediately To prevent damage do not soak or immerse the sensor in any liquid solution Do not attempt to sterilize CAUTION Do not use SpO2 sensors or cables tha
19. caution with poorly perfused patients Excessive ambient light may cause inaccurate SpO2 measurements In such cases cover the sensor site with opaque material 0070 10 0603 0 1 Duo Operating Instructions Operation Routine Operation 2 3 3 1 Masimo SET SpO The Masimo pulse oximeter determines SpOz in the traditional manner of passing red and infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle It assumes that arterio venous shunting is highly variable and that fluctuating absorbance by venous blood is the major component of noise during the pulse The Masimo pulse oximeter calculates the ratio of the arterial signals without the noise Masimo SET provides a family of sensors suitable for a wide variety of clinical settings and patient sizes All sensors are e Indicated for continuous non invasive monitoring of arterial oxygen saturation SpO and Pulse Rate e Non sterile e Usable during patient movement The LNOP DCI Adult Reusable Finger Sensor is used for spot check applications if needed Adhesive type sensors are also available Refer to Accessories on page 4 1 for approved sensors All sensors are intended for single patient use only unless indicated as reusable CAUTION When equipped with Masimo SpO2 use only Masimo oxygen sensors and cables Use of other oxygen sensors may cause improper oximeter performance NOTE Refer to instruct
20. illuminate The NIBP start stop LED will not be illuminated when the NIBP measurement is complete or has been stopped A measurement can be manually stopped by the user or it can stop due to an error NIBP error codes are displayed in the Sys area of the NIBP parameter tile as described in section 2 4 Information Codes and Error Codes 0070 10 0603 01 Duo Operating Instructions General Product Description Controls and Indicators 2 Keypad The Duo keypad shown in FIGURE 1 4 is used to initiate all functions To confirm that a key has been successfully activated two forms of feedback are provided Manual feedback is provided in the form of a click that can be felt under the fingertip Audible feedback is provided in the form of a single beep tone when the operation associated with that key is executed FIGURE 1 4 Keypad a Power ON OFF e This key is used to power the Duo ON or OFF It is also used to exit standby mode and return to normal monitoring mode The power OFF function features a time delay of two 2 seconds minimum When powering the Duo OFF the user must depress the key for a minimum of 2 seconds NOTE If the Power ON OFF key is depressed for less than two 2 seconds the monitor will not power OFF e When the Duo is powered OFF all parameter data is permanently deleted b Clear Next Patient e While in normal monitoring mode this key is used to delete all data including an NIBP E13 one
21. nut for the optional rolling stand are located on the bottom panel as shown in FIGURE 1 7 FIGURE 1 7 Bottom Panel a Mounting Nut e The mounting nut secures the Duo to the optional rolling stand b Battery Compartment e The battery compartment houses one user replaceable rechargeable Lithium lon battery For ease of use the door for the battery compartment is tethered to the bottom panel and features a molded finger grip 0070 10 0603 01 Duo Operating Instructions 20 Operation Dal Modes of Operation The Duo functions in the following four 4 operating modes e Normal Monitoring Mode e Standby Mode e Auto Shutoff Mode e Maintenance Mode 2 1 1 Normal Monitoring Mode The Normal Monitoring Mode is the mode from which all monitoring functions are initiated during routine operation of the Duo 2 1 2 Standby Mode This feature is designed to save power while the Duo is running on battery power The Duo can only enter Standby Mode from Normal Monitoring Mode and only while it is functioning on battery power It cannot enter Standby M
22. required by local statutory or hospital administration practice General Maintenance Before using the Duo perform the following general maintenance checks 1 Performa visual inspection of the exterior of the device external cables inserted modules and accessories Replace damaged cables modules and accessories as necessary NOTE If any damage is found on the exterior of the device contact the biomedical engineer of the facility or Customer Service immediately 2 Verify that all device functions operate properly If operating problems cannot be corrected contact the Service Department at 1 800 288 2121 or 201 995 8116 for assistance in determining the nearest field service location Please be prepared to provide the instrument part number the serial number and a description of the problem with all requests for service 3 Clean the device as needed as described in the following sections Duo Operating Instructions 0070 10 0603 01 Care and Cleaning of the Monitor User Maintenance 3 2 3 3 3 3 1 Care and Cleaning of the Monitor The monitor housing may be cleaned with a mild soap and water solution or ammoniated window cleaner Apply cleaning solution to the cloth not directly onto the monitor DO NOT apply large amounts of liquid DO NOT use abrasive cleaning agents or organic solvents WARNING Do not clean the monitor while it is ON and or connected to AC power To prevent scratches on the screen
23. the noise The interference may be due to motion excess infrared light or electrical optical interference The message is removed when the noise is removed The Nellcor module senses an unstable or illegal sensor This may also be due to a poor connection or a bad sensor The user is required to reconnect the same sensor or connect a new sensor The message is removed once the Nellcor module clears the error A pulse rate can not be determined and all other measurement conditions are normal The message is removed when a pulse is detected Noise is detected but a pulse rate can not be discriminated The message is removed when a pulse is detected Motion is detected The message is removed when No Pulse status is detected or when motion ceases SpO2 has been determined continuously for more than 2 minutes so SpO2 data has timed out from the display PR value exceeds the measurement range Battery voltage is low Information Codes and Error Codes 2 4 2 Error Codes MESSAGE TYPE NIBP MASIMO SPO2 NELLCOR SPO2 GENERAL TECHNICAL CODE EO E02 E04 EOS E12 E14 El5 El El7 E24 E25 E26 E42 E45 E504 E505 E506 DESCRIPTION NIBP SELF TEST ERR NIBP COMM ERR AIR LEAK AIR PRESSURE FAILURE NIBP SYSTEM FAILURE NIBP ILLEGALLY RESET NIBP RESET FAILED NIBP COMM CRC ERROR NIBP PATIENT SIZE CHANGE ERR SPO2 COMM ERROR SPO2 BOARD FAULT SPO2 SENSOR FAUL
24. 0070 10 0604 0 1 2 3 Calibration and System Checks Calibration and Performance Verification 2 4 4 Software Version Mode Use the following procedure to view the software version 1 Ensure that the Duo is powered OFF 2 Press and hold the Patient Size key 3 While continuing to hold the Patient Size key press and hold the Power ON OFF key for two 2 seconds until the Duo beeps 4 Release both keys 5 After an additional 2 second delay Duo will display 100 in the Pulse Rate tile and a number in the Information Codes tile 6 Pressing the Clear key will cause the number displayed in the Pulse Rate tile to cycle through a sequence of four numbers indicating which software version is being displayed in the Information Codes tile as shown in the following table PULSE RATE TILE INFORMATION CODES TILE SHOWS 100 Host Software Revision Level 200 NIBP Software Revision Level 300 SpO2 Software Revision Level 7 To return to normal operation press the Power ON OFF key for two 2 seconds to turn the Duo off 8 You may then turn the Duo back on to resume normal operation NOTE The Duo cannot be placed directly back into normal monitoring mode from Software Version Mode lt must first be powered OFF 2 4 0070 10 0604 0 1 Duo Service Manual Calibration and Performance Verification Safety Test 2 5 Safety Test 2 5 1 Test Equipment e Safety Analyzer Dempsey model 431 or equivalent 2 5 2 Case Leakage 1 Plu
25. E Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Patient Parameter Specifications Appendix TABLE 5 2 GUIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The Duo is intended for use in the electromagnetic environment specified below The customer or the user of the Duo should assure that it is used in such an environment IMMUNITY IEC 60601 COMPLIANCE ELECTROMAGNETIC TEST TEST LEVEL LEVEL ENVIRONMENT GUIDANCE Voltage dips lt 5 Un gt 95 lt 5 Ur gt 95 Mains power quality should be that of short dip in Uy for dip in Ur for0 5 a typical commercial or hospital interruptionsand 0 5 cycle cycle environment If the user of the Duo voltage requires continued operation during variations on 40 UT 60 40 UT 60 power mains interruptions it is power supply dip in Uy for dip in Uy for recommended that the Duo be input lines IEC 5 cycles 5 cycles powered from an uninterruptible power 61000 4 1 1 supply or a battery 70 UT 30 70 UT 30 dip in Uy for dip in Uy for 25 cycles 25 cycles lt 5 UT gt 95 lt 5 UT gt 95 dip in Uy for5 dip in Uy for 5 sec sec Power frequency 3 A m 3 A m Power frequency magnetic fields 50 60 Hz should be at l
26. E Refer to instructions included with each SpO sensor and cable for proper placement and use 1 Select an SpO5 sensor that is appropriate for the size of the patient 2 Attach the SpO sensor to the patient s finger 3 Attach the connector end of the SpO sensor to the SpO7 extension cable 4 Plug the connector from the SpO extension cable pe As ee into the SpO7 receptacle on the front panel of the H Di H Duo The SpO measurement will display when OF ML the Duo detects that the sensor is connected to 111 I the patient J These results are updated once every second and can display for a maximum of 2 minutes during continuous SpO9 measurement NOTE To disconnect the cable from the Duo squeeze the tabs on the sides of the connector and then pull it straight out 0070 10 0603 01 Duo Operating Instructions Operation Information Codes and Error Codes 2 4 Information Codes and Error Codes In addition to numeric values for the monitored parameters the digital LED display of the Duo provides information codes and error codes to indicate the operational status of the monitor e Codes that refer to the operational status of the monitor are preceded by a capital letter E e Codes that indicate that the device is in Maintenance Mode are numeric only
27. EASON Masimo SpO Pulse Rate Exceeded Nellcor SpO gt PR Exceeded Nellcor SpO Interference Nellcor SpO gt Check Sensor Nellcor SpO Communication Error Nellcor SpO Weak Pulse Nellcor SpO9Weak Signal Nellcor SpO Board Fault Nellcor SpO9 Motion Nellcor SpOg Timeout Unit Battery Voltage Low Unit Keyboard Error 1 Monitor Shut Off Failure SpO Module Not Recognized 0070 10 0604 01 SOLUTION Pulse Rate value exceeds the measurement range Pulse Rate value exceeds the measurement range Noise is detected on the pulse signal preventing pulse discrimination from the noise The interference may be due to motion excess infrared light or electrical optical interference The message is removed when the noise is removed The Nellcor module senses an unstable or illegal sensor This may be due to a poor connection or a bad sensor The user is required to reconnect the same sensor or connect a new sensor The message will be removed once the Nellcor module clears the error The front end module is having problems communicating i e framing errors or bad checksums with the Nellcor module A pulse rate can not be determined and all other measurement conditions are normal The message is removed when a pulse is detected Noise is detected but a pulse rate can not be discriminated The message is removed when a pulse is detected The SpO board has malfunctioned Motion is detected
28. IGURE 2 3 Application of the Blood Pressure Cuft 5 Ensure that the appropriate patient size has been selected on the Duo 6 Press the NIBP Start Stop key to begin the NIBP measurement Duo Operating Instructions 0070 10 0603 0 1 2 7 Routine Operation 2 3 2 Operation The cuff begins to inflate After reaching the default pressure for the selected patient size the cuff slowly deflates and the Duo collects oscillometric pulsations During this inflation and deflation portion of the measurement the MAP section of the NIBP parameter tile displays the current pressure in the cuff During this same period the Sys and Dia sections of the 11 n NIBP parameter tile display dashes The patient should remain still to avoid the introduction of unnecessary motion artifact After the cuff pressure drops below the diastolic pressure the measurements are displayed in the NIBP parameter tile These results will be deleted and the NIBP parameter tile will be blank if one of the following occurs e 15 minutes elapse since the last NIBP measurement e The Clear Next Patient key is pressed to clear the results e The Duo is powered OFF If the Duo enters Standby Mode the internal counter for the elapsed time since the last NIBP measurement continues If Normal Monitoring Mode resumes before the counter reaches 15 minutes the NIBP results will display until one of the previous bulleted items occurs or the Duo again enters Standby Mode N
29. MAP There is no provision for interval measurement Each measurement must be initiated by pressing the NIBP Start Stop key while the Duo is in normal monitoring mode The initial default cuff inflation pressure is dependent on the patient size setting as follows PATIENT SIZE DEFAULT CUFF SETTING INFLATION PRESSURE Adult 178 5 mmHg Pediatric 133 5 mmHg If the Duo is in normal monitoring mode then the selected NIBP unit of measure LED will be illuminated red regardless of whether there is an NIBP value being displayed Upon power ON of the Duo the NIBP unit of measure setting defaults to the most recent setting made in the Unit of Measure mode During the inflation and bleed portions of the NIBP measurement the current cuff pressure displays in the MAP section of the NIBP parameter tile and updates approximately once every second After the first successful measurement the subsequent inflation pressure for the same patient will be 50 10 mmHg above the previous systolic pressure measurement 0070 10 0603 0 1 Duo Operating Instructions Operation Routine Operation If a measurement cannot be obtained the Duo automatically reinflates the cuff to 30 60 mmHg higher than the initial inflation pressure but will not exceed the maximum cuff pressure listed in the NIBP Sub System Functional Requirements section 5 2 6 This process will only repeat three times and then an associated error code will be displa
30. OTE Pressing the NIBP Start Stop key while the NIBP measurement is in progress will stop the measurement and deflate the cuff Pulse Rate Measurement The Pulse Rate is determined from one of two sources SpO and NIBP NOTE If the optional SpO is not purchased with the Duo the Pulse Rate source will be NIBP by default SpO is the higher priority source If both SpO and NIBP are being actively monitored SpO will be the source for the Pulse Rate measurement If only NIBP is being actively monitored it will be the source for the Pulse Rate measurement e When determined from SpO the Pulse Rate updates approximately once every second When SpO is no longer being monitored the Pulse Rate parameter tile will be blank e When determined from NIBP the Pulse Rate will display until the NIBP results are no longer displayed as described in section 2 3 1 NOTE Pulse Rate from NIBP is a static value since NIBP is a static one time measurement The Pulse Rate results will display for the same maximum time that the source parameter SpO gt or NIBP is displayed 0070 10 0603 0 1 Duo Operating Instructions Operation 2 3 3 Routine Operation SpO Measurement Optional Each of the following terms are associated with blood oxygenation oxygen saturation pulse oximetry SpO and plethysmography Oxygen saturation in capillary blood is measured by a method called pulse oximetry Pulse oximetry is a continuous and no
31. PEDIATRIC MODE 40 to 240 bpm 40 to 240 bpm NIBP Sub System Functional Reguirements Maximum Cuff Pressure The software controlled over pressure monitor vents to atmosphere at the following pressures ADULT MODE PEDIATRIC MODE 297 3 mmHg 243 3 mmHg Under single fault conditions the hardware controlled over pressure mechanism vents the cuff to atmosphere so that the pressure in the cuff does not exceed the following ADULT MODE PEDIATRIC MODE 300 10 mmHg 300 10 mmHg Cuff Inflation The inflation source is capable of supplying sufficient air to bring a volume of 500 cc to a pressure of 300 mmHg in no more than 20 seconds If the cuff is not inflated 5 mmHg within 18 seconds the cuff is vented and the measurement is stopped Maximum Leakage The maximum allowed pressure drop with the bleed valves closed is 6 mmHg in 60 seconds as measured with a 500 cc volume at differential pressures of 250 mmHg 150 mmHg and 50 mmHg Vent Rate A volume of 500 cc when vented is reduced from a pressure of 260 mmHg to a pressure of 15 mmHg in a maximum of 10 seconds Initial Conditions An NIBP Zero is performed automatically before the NIBP can be initiated An NIBP measurement will not initiate until the unit has been powered on for 5 seconds in order to allow time for the Zero Duo Operating Instructions 0070 10 0603 01 5 5 Patient Parameter Specifications Appendix 5 2 6 6 5 2 6 7 JAT 5 2 7 1 5 2 1
32. States Food and Drug Administration Documents esse eececeeeeeseeeeeeeesesssaeeeeeeesssaaeeeeeees 5 3 Patient Parameter opeciticdhon Steet it a a i NS eas a aaa 5 4 NIBP Sub System Performance Characteristics iii cias 5 4 Duo Operating Instructions 0070 10 0603 01 i Table of Contents Systolic Pressure Medsureme Ni stola e 5 4 Diasiolic Pressure Measwiementi arie i i ai aa i a a anne a a 5 4 slane Pressure MESE ME L 225 62 iaia 5 4 Pulse Rate from UB utile a a L as 5 5 NIBP Sub System Functional Requirements Kasis sansu ii ss Aaa a a a i i a a i 5 5 SBO gt Pertormicini ce Requirements 5 6 PONGE UD siais e a io kad sias ki a a I a i ai a a RemT eee reer at 5 10 AG Mains Power soccer 5 10 A O areas Acachea tenets 5 10 A G MONG ter SHES ace se aaa O iaia 5 11 Cooling ICG inas tact O actA alinea ila date et 5 11 Environmental and SaletyiCharacieristio laicale 5 11 A Ee ime IIS asis sara sa asi a a i a a T a N 5 17 Manufacturer s Res polis DIN 545545 aa iai i ed a ata la a aa a a a a a a e a L Oe Dae die aa a a 5 19 ij 0070 10 0603 01 Duo Operating Instructions Foreword Introduction Foreword The Duo Operating Instructions are intended to provide information for proper operation General knowledge of monitoring and an understanding of the features and the functions of the Duo Monitor are prerequisites for proper use Do not operate this monitor before reading these instructions Information for servicing t
33. T SPO2 COMM ERROR SPO2 BOARD FAULT KEYBOARD ERR MONITOR SHUTOFF FAILURE SPO2 MODULE NOT RECOGNIZED 0070 10 0603 01 Operation REASON NIBP module hardware failure Communication with NIBP module has failed Cuff hose or connector is damaged Internal leak Stable pressure value is not available e g hoses are pinched or occluded Operation of blood pressure pump system failed Unexpected NIBP reset NIBP reset failed NIBP Serial Communication failure Attempt to change patient size failed The monitor and the SpO2 modules are not communicating properly Masimo SET board failed to operate properly Defective sensor The front end module is having problems communicating i e framing errors or bad checksums with the Nellcor board The SpO2 board malfunctions Error with front panel keypad board Monitor cannot be turned off normally Monitor cannot communicate with the SpO2 module during self test Duo Operating Instructions 30 User Maintenance 3 1 Introduction This section of the manual outlines routine maintenance to be performed by the user and or biomedical technician The Duo monitor is designed for stable operation over long periods of time and under normal circumstances should not require technical maintenance beyond circumstances described in this section In general routine maintenance calibration and safety checks are recommended annually or more often as
34. a 2 3 Umro PSS US MOS da 2 3 SOnwWare Version Md a a L a a 2 4 SA A a a a a ee 2 5 Tesk Equipment ai sias a i a AS AA i a S 2 5 El A iii A Re em aT CTP eC Ot eT 2 5 NAS o aaa 2 6 E A E SE 2 6 Jlest Pioeedure arie 2 6 A 2 8 Test Egq ipmenkeea cenaa de ee alii 2 8 lesh Procedu A A A a 2 8 POINTS cionado S A a TT eS Restrnt waren i a enema terre D L eee are 3 1 RUSSI A RA E ARR a K I da a 3 10 Repair INFOFIMGHON 3 00 Ts Al iodio a E E E EEE 4 1 lo r ole llo RE 0 a RE 0 ile alinea 4 2 Disassembly Asu e ia a Ti a a a Uoniotaase Suigaesaupaeees 4 6 A A sian ai O S 4 6 Front MOUSE MOMA siriani rl as a At a A a a as a tut a aa a oe 4 6 Sp O gt nlemace Board Remove Last a is a I k a a Ss a S 4 6 POS oe go lujo Gl r a cil 4 6 CP DispleBodfa REM kais iii 4 6 NIBP Mali e loo zinau a sade rene na a a a i i a a a a ecunes fel 4 6 Power SUPP REM OVAL errate aiar 4 7 Duo Service Manual 0070 10 0604 01 i Table of Contents This page intentionally left blank 0070 10 0604 0 1 Duo Service Manual Foreword Duo Service Manual Introduction Foreword This service manual gives a detailed description of the Duo Portable Patient Monitor including circuit descriptions test and calibration procedures and spare parts listings This manual is intended as a guide for technically qualified personnel during repair testing or calibration procedures Warnings Precautions And Notes Please read and adhere to all warnings p
35. a i ae ae 2 1 Normal Monitoring Mo lesa asas ikos A a a a Some 2 1 A 2 1 Aulo SING Me NS Se sate hater Plc htt a A AS 2 2 Maltenanes Mode cea Ged Wat i a o i i a e IL 2 2 Himal Ser DT 2 ee as na Aaa i Re cecal ghee o eil 2 3 Setting the Units of Measure Units of Measure Mode aaa aaa kaka aaa aaa aaa aaa aa aa kaka 2 4 Route Operation A leale O 2 6 AU GS ko L S MI cel O i i i a i li 2 6 Pulse Rate Measuremeni i Lelli Le a Game 2 8 SPO gt Meds remeni ODOM Mae gilda dada 2 9 informano Codesand Eror Codos esile 2 13 ETONE ode EAN 2 14 Enor OSS ST 2 16 User Maintenance AA TAS NL A o a a a a aa A i a a a a A 3 1 Care and Cleaning of the Monti di id ia tt 3 2 Gare and Cleaning of Accessories iia di A di AAA 3 2 SPOREN OS aes Reali 3 2 Care a a Cleaning o Reusable Gulls cari talea 3 3 Battery Replacement and VCIM CMON CG espacial 3 5 Accessories 000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000eccececcceceecoeeo0e 4 1 A A UTO IE RR OO SIONE RR RION E 4 1 Ophonal Altes Ones 55 55 einas na S aa delli dina ea 4 2 NIBP ACCES OMS bll i i i pits bay a a i a i nies I a a r i gansin 4 2 SPO ACOSO SA iii aliene 4 3 Miscellaneous A ail alti AN 4 3 A A aa I Spec e E A a i a i ire 5 1 So NA o A o ROOT VITTO VET eee TAO 5 1 Sale D signalrensa curava i acto 5 2 Flazatd Abalysis RiskeManagemeni cele a a a a a a a 5 2 Parrormancs ACCULAGY alici 5 2 United
36. accordance with the instructions for use Duo Operating Instructions 0070 10 0603 0 1 5 19 0070 10 0603 01 Rev E May 24 2010 Service Manual Datascope Duo NORTH AMERICA Duo is a US trademark of Mindray DS USA Inc Navigator is a U S trademark of Mindray DS USA Inc Masimo SEIS LNOP and CleanShield are U S registered trademarks of Masimo Corp Copyright Mindray DS USA Inc 2008 All rights reserved Contents of this publication may not be reproduced in any form without permission of Mindray DS USA Inc 0070 10 0604 01 Duo Service Manual Table of Contents RONNIE A PP TRIO a TOI S a a a a a tetas iii Warnings Precavions And Nole iii Theory of Operation 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000060 1 gt 1 Ll igor e UCNON as RE i i a aa ss L a a A a L a a 1 1 Vie TN 1 2 Power SUDDIY BOO lr al rete 1 2 Fam DT Wer Odi A AAA talia 1 4 CPU Display BogrdOvenieW alli loi 1 4 NM A lai ib eli ia 1 5 POE alicell cena ual ici lele lisis 1 6 Calibration and Performance Verification ccccccccccccsccccccccccccccccccccccccccccccccccccccccccccccccs 2 T bodies 2 1 Wornmgs and UA A a ans a i a a a A i i a i a S 2 2 lest Equinment and Special lools REQuireo israeliana 2 2 Caliprationvand System Checks o to da ae nee a le e BOO as 2 3 Device Appearance and Installation Check ii A ea i 2 3 Maintenance Functions Non Monitoring Modes ti
37. age to any product or parts through misuse neglect accident or by affixing any non standard accessory attachments or by any customer modification voids this warranty Mindray DS USA Inc makes no warranty whatever in regard to trade accessories such being subject to the warranty of their respective manufacturers A condition of this warranty is that this equipment or any accessories which are claimed to be defective be returned when authorized by Mindray DS USA Inc freight prepaid to Mindray DS USA Inc Mahwah New Jersey 07430 Mindray DS USA Inc will not have any responsibility in the event of loss or damage in transit Duo Operating Instructions 0070 10 0603 0 1 5 17 Warranty Statements Appendix Calibration may be performed without the need to disassemble the instrument It is the responsibility of the purchaser to perform calibration as necessary in accordance with the instructions provided in this manual 5 18 0070 10 0603 01 Duo Operating Instructions Appendix Manufacturer s Responsibility 5 4 Manufacturer s Responsibility Mindray DS USA Inc is responsible for the effects on safety reliability and performance of the equipment only if assembly operations extensions readjustments modifications or repairs are performed by persons authorized by Mindray DS USA Inc and 2 the electrical installation of the relevant room complies with the appropriate requirements and c the equipment is used in
38. ailed Cuff is not properly wrapped or no cuff is present Cuff hose or connector is damaged internal leak Stable pressure value is not available e g hoses are pinched or occluded Indicates NIBP pneumatic test was successful Leak detected during the pneumatic test Cuff is too loose or patient pulse is too weak NIBP value exceeds the upper measurement limit Monitor is detecting too much motion and or noise to obtain a reading Pressure has exceeded the specified upper safety limit Operation of blood pressure pump system has failed Measuring time has exceeded 120 seconds Unexpected NIBP reset NIBP reset failed NIBP Serial Communication CRC failure Attempt to change Patient Size failed Noise detected on the pulse signal prevents pulse discrimination Patient perfusion is low There is too much ambient room light for the sensor to function properly The monitor does not recognize the sensor The monitor and the SpO9 module are not communicating The Masimo SET board has failed to operate properly Defective sensor SpO data has been determined continuously for more than 2 minutes so SpO data has timed out from the display The SpO signal quality is poor Duo Service Manual Repair Information Duo Service Manual Troubleshooting Guide Error Codes and Solutions Continued MESSAGE PROBLEM E34 E34 E40 E41 E42 E43 E44 E45 E46 E47 ESO1 E504 E505 E506 R
39. andard Kits Masimo SET Adult Ped Single Patient Adhesive 0020 00 0123 01 DESCRIPTION PART NUMBERS 2 LNOP Adt Adult Single Patient Adhesive Finger Sensor 0600 00 0043 02 2 LNOP Pdt Pediatric Single Patient Adhesive Finger Sensor 0600 00 0044 02 1 Patient Cable 12 3 7 m 0012 00 1099 02 Duo Operating Instructions 0070 10 0603 01 Optional Accessories 4 2 4 2 1 Optional Accessories NIBP Accessories Hoses DESCRIPTION NIBP Hose 5 1 5 m Female Rectus Female Rectus PART NUMBERS 0683 04 0003 Accessories for use with Reusable Cuffs and Adult Child Disposable Cuffs NIBP Hose 10 3 5 m Female Rectus Female Rectus 0683 04 0004 for use with Reusable Cuffs and Adult Child Disposable Cuffs Reusable Cuffs Quick Connect DESCRIPTION Reusable NIBP cuff Child 10 to 19cm quick connect PART NUMBERS 0683 15 0001 01 Reusable NIBP cuff Small Adult 18 to 26cm quick connect Reusable NIBP cuff Adult 25 to 35 cm quick connect 0683 15 0002 01 0683 15 0003 01 0683 15 0004 01 Reusable NIBP cuff Large Adult 33 to 47cm quick connect Reusable NIBP cuff Thigh 46 to 66cm quick connect 0683 15 0005 01 Reusable NIBP Cuff Adult Long 25 35 cm quick connect 0683 15 0006 01 0683 15 0007 01 Reusable NIBP Cuff Large Adult Long 33 47 cm quick connect Disposable Cuffs Quick Connect DESCRIPTION Disposable NIBP cuff Child 10 to 19cm quick connect box
40. ant other than fresh water or 70 isopropanol Clean and disinfect the cuff according to the instructions Duo Operating Instructions 0070 10 0603 0 1 3 3 Care and Cleaning of Accessories User Maintenance 3 3 2 2 3 3 2 3 Reusable Bladderless Cuffs Clean cuffs with warm water and a mild detergent Do not use a detergent containing hand conditioners softeners or fragrances NIBP cuffs can be sterilized with gamma sterilization without affecting the repeated performance of the cuff Steam sterilization is not recommended Use of a washing liquid containing bleach is not recommended because chlorine will chemically break down the urethane on the inside of the cuff Antimicrobial Definition Bladderless cuffs are treated with an antimicrobial coating Antimicrobial technology effectively controls a broad spectrum of bacteria fungi algae and yeasts on a wide variety of treated substrates Disposable Blood Pressure Cuffs Disposable cuffs are intended for single patient use only Once a cuff is used on a patient it should be discarded Do not use the same cuff on any other patient Do not sterilize or use an autoclave on disposable cuffs NOTE Disposable cuffs can be cleaned using a mild soap solution and dried with a clean cloth For Cuffs with bladders remove bladder before cleaning 0070 10 0603 01 Duo Operating Instructions User Maintenance Battery Replacement and Maintenance 3 4 Battery Replacement and Maint
41. assure that it is used in such an environment EMISSIONS TEST RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 6 1000 3 2 Voltage fluctuations Flicker emissions IEC 6 1000 3 3 TABLE 5 2 COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE Group 1 The Duo uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Class A The Duo is suitable for use in all establishments other than domestic establishments and those directly Class A connected to the public low voltage power supply network that supplies buildings used for domestic purposes Complies GUIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The Duo is intended for use in the electromagnetic environment specified below The customer or the user of the Duo should assure that it is used in such an environment IMMUNITY TEST Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Duo Operating Instructions IEC 60601 COMPLIANCE TEST LEVEL LEVEL 6 kV contact 6 kV contact 8 kV air 8 kV air 2 kV for power 2 kV for power supply lines 1 supply lines 1 kV for input kV for input output lines output lines 1 kV 1 kV differential differential mode 2 kV mode 2 kV common mode common mode 0070 10 0603 01 ELECTROMAGNETIC ENVIRONMENT GUIDANC
42. cause skin irritation Please rinse the NIBP cuffs thoroughly with water to remove any residual disinfectants Using dark colored soaps may stain the NIBP cuffs Test a single cuff to ensure that no damage will occur Disposable NIBP cuffs can be cleaned using a mild soap solution and dried with a clean cloth Replace the Lithium lon battery with part number 0146 00 0079 only Remove the battery if the Duo is not likely to be used for an extended period of time Remove the battery prior to shipping the Duo To avoid permanent damage do not expose metal components e g pins and sockets to disinfectants soaps or chemicals Only connect NIBP Luer fittings to Blood Pressure Cuff or Monitor 0070 10 0603 01 vii Introduction viii Notes Notes NOTE Potential hazards due to errors in software or hardware have been minimized by actions taken in accordance with IEC 60601 1 4 NOTE Information codes and error codes with corresponding explanations are provided to assist in the identification and correction of problems that may occur with the monitor NOTE The comparison testing conducted via the auscultatory method used both Phase 4 and Phase 5 Korotkoff sounds A report of the study finding for the auscultatory method is available by contacting Technical Support 201 995 8116 NOTE The use of this equipment is restricted to one patient at a time Indication for Use The Duo monitor is intended for use in h
43. cted into patient Patient movement Patient is cold Patient is wearing nail polish 0070 10 0604 01 Troubleshooting Guide SOLUTION Check hose and cuff Replace as needed Keep the patient quiet Reapply cuff Use appropriate size cuff Ensure correct cuff application Calibrate replace NIBP module Check sensor placement and connection Replace if damaged Check sensor placement and connection Replace if damaged Retry after the coloring agent has dissipated Keep patient quiet Warm patient and retry Remove nail polish Disassembly Instructions 4 3 4 3 1 4 3 2 4 3 3 4 3 4 4 3 5 4 3 6 Repair Information Disassembly Instructions Before disassembling the unit perform the following e Turn off the unit and remove the line cord e Remove all cables and hoses e Remove the battery e Perform all maintenance on a properly grounded work station Tools Needed e Phillips Screwdriver e 5 mm nutdriver Front Housing Removal 1 Remove four 4 3 x 30 mm Phillips panhead machine screws from the corners of the Rear Housing 2 Carefully separate the front and rear housings and disconnect the cables from the CPU Display PCB connectors PO2 PO3 and PO7 Disconnect the NIBP tubing from the front housing pressure fitting SpO gt Interface Board Removal 1 Disconnect the cable from PO1 on the CPU Display pcb 2 Remove three 3 5mm hexnuts from their stand offs on the SpO pcb 3 Lift
44. ealth care settings under the direct supervision of a licensed health care practitioner The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients Physiologic data includes non invasive blood pressure NIBP pulse oximetry and pulse rate as summarized in the operating instructions manual The information can be displayed only The monitor is not intended for home use Unpacking Remove the instrument and accessories from the shipping cartons and examine them for signs of damage Check all materials against the packing list Save the invoice bill of lading and all packing materials These may be required to process a claim with the carrier Contact a Sales Representative or Distributor for assistance in resolving shipping problems 0070 10 0603 01 Duo Operating Instructions Symbols Symbols SYMBOL Duo Operating Instructions DESCRIPTION Attention Consult Accompanying Documents SYMBOL 1 2 H Refer to Manual Dangerous Voltage Equipotentiality En A lt Alternating Current AC ON OFF only for a part of the equipment Patient Size Adult Pediatric C AR Non ionizing electromagnetic radiation 0070 10 0603 01 Introduction DESCRIPTION Type BF Equipment Defibrillator Proof Type BF Equipment Battery Charging NIBP Data Input Output Clear Next Patient Consult Operating Instructions A symbol designating compl
45. enance Battery Replacement CAUTION Replace the Lithium lon battery with part number 0146 00 0079 only 1 Remove the battery compartment door 2 Disengage the battery locking mechanism by moving its plastic tab away from the edge of the battery see 3 1 Remove the battery Battery Compartment Door Battery Locking Mechanism tty x lil tt x gt YY Tm FIGURE 3 1 Battery Compartment 3 The battery compartment is shaped so that the battery can only be inserted in the proper orientation Insert the new Lithium lon battery with its contacts shown in 3 2 facing the rear of the compartment Contacts FIGURE 3 2 Lithium lon Battery Duo Operating Instructions 0070 10 0603 0 1 3 5 Battery Replacement and Maintenance User Maintenance 4 Ensure that the locking mechanism engages over the end of the battery by pressing the battery firmly into the compartment 5 Replace the battery compartment door Battery Maintenance and Disposal CAUTION Remove the battery if the Duo is not likely to be used for an extended period of time CAUTION Remove the battery prior to shipping the Duo The Duo monitor uses a Lithium lon battery This type of battery may be subject to local regulations regarding disposal At the end of battery life dispose of the batteries in accordance with any local regulations 3 6 0070 10 0603 01 Duo Operating Instructions 40 Accessories 4 1 St
46. er setting the units of measure It must first be powered OFF 0070 10 0603 0 1 2 5 Routine Operation 2 3 2 3 1 Operation Routine Operation This section provides guidelines and step by step instructions for the vital sign measurements that are routinely performed with the Duo NIBP Measurement CAUTION A patient s skin is sometimes fragile i e on pediatric and geriatric patients or due to physiological conditions In these cases a longer duration between NIBP measurements should be considered to decrease the number of cuff inflations over a period of time In extreme cases a thin layer of soft roll or cotton padding may be applied to the limb in order to cushion the skin when the cuff is inflated This may affect NIBP performance and should be used with caution CAUTION Please consult a physician for interpretation of blood pressure measurements CAUTION A blood pressure measurement can be affected by the position of the patient and his her physiological condition as well as other factors such as patient movement CAUTION Any condition that may affect the regularity and strength of arterial pressures such as patient movement cardiac arrhythmias restriction of hose etc will affect the accuracy and ability to measure the NIBP The Duo utilizes the oscillometric method of measuring Non Invasive Blood Pressure NIBP The measurement includes systolic Sys diastolic Dia and mean arterial pressure
47. erence by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Duo as recommended below according to the maximum output power of the communications equipment RATED MAXIMUM OUTPUT POWER OF SEPARATION DISTANCE ACCORDING TO FREQUENCY TRANSMITTER W WATTS OF TRANSMITTER M METERS 150 kHz to 80 MHz to 800 MHz to 80 MHz 800 MHz 2 5 GHz D 1 2x VP D 1 2x VP D 2 3 x 4P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 9 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be determined using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NOTE The Duo is intended for use in the electromagnetic environment specified below The customer or the user of the Duo should assure that it is used in such an environment e The Duo meets the additional electromagnetic compatibility requirements of the FDA Reviewer Guidance for Pre market Notification Submission November 1993 listed below AC Voltage Drop
48. evels characteristic of a magnetic field typical location in a typical commercial IEC 61000 4 8 or hospital environment Uy isthe A C mains voltage prior to application of the test level 5 14 0070 10 0603 0 1 Duo Operating Instructions Appendix TABLE 5 3 Patient Parameter Specifications GUIDANCE AND DECLARATION ELECTROMAGNETIC IMMUNITY The Duo is intended for use in the electromagnetic environment specified below The customer or the user of the Duo should assure that it is used in such an environment IMMUNITY TEST Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 NOTE NOTE IEC 60601 TEST LEVEL 3 Vrms 150 kHz to 80 MHz 3 V m 80 MHz to 2 5 GHz COMPLIANCE LEVEL 3 Vrms 3 V m ELECTROMAGNETIC ENVIRONMENT GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the Duo including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2x JP d 1 2x JP 80 MHz to 800 MHz d 2 3 x JP 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency
49. g the line cord of the unit into the safety analyzer 2 Connect the case ground lead of the analyzer to the equipotential lug of the Duo monitor 3 Perform the leakage tests under the following conditions a Case grounded Normal polarity Normal polarity with open neutral Reverse polarity b Case ungrounded Normal polarity Normal polarity with open neutral Reverse polarity 4 Verify the current reading is lt 100 uA under normal operating conditions lt 300 UA under single fault conditions for 120 VAC and lt 500 uA under single fault conditions for 230 VAC Duo Service Manual 0070 10 0604 01 225 NIBP Calibration 2 6 2 6 1 2 6 2 2 6 2 1 2 6 2 2 2 6 2 3 Calibration and Performance Verification NIBP Calibration Test Equipment NIBP simulator NIBP test chamber dummy cuff Manometer with bulb Test Procedure Transducer Accuracy 2 Connect the 500 cc Test Chamber and calibrated manometer via a T fitting to the NIBP fitting on the Duo monitor under test Ensure the Duo is not turned on Simultaneously press and hold the POWER and NIBP START STOP buttons When the monitor enters the NIBP Calibration Mode message code 525 will be displayed in the Information Codes window Release the buttons simultaneously Momentarily press the NIBP START STOP button to start the NIBP calibration Vent the Test Chamber and verify the Duo and the manometer read zero Using the bulb pressurize the tes
50. gs for NIBP Pulse Rate and SpO optional If any portion of the internal diagnostics test fails error codes are displayed in specific YP g p ay p parameter tiles as described in Information Codes and Error Codes on page 2 13 Setting the Units of Measure Units of Measure Mode The NIBP parameter has 2 choices for the unit of measure This setting is maintained after the Duo is powered OFF The units of measure for Pulse Rate bpm and SpO5 76 are not adjustable e The NIBP units of measure are mmHg and kPa The default setting is mmHg 0070 10 0603 01 Duo Operating Instructions Operation Initial Set Up Use the following procedure to change the units of measure 1 Ensure that the power to the Duo is OFF 2 Press and hold the Clear Next Patient key 3 While continuing to hold the Clear Next Patient key press and hold the Power ON OFF key for two 2 seconds until the Duo beeps 4 Release both keys 5 After an additional 2 second delay the Duo will light the LED to show the currently stored setting of the NIBP unit of measure 6 Press the Clear Next patient key repeatedly until the desired NIBP mmHg or kPa unit of measure is showing 7 Press the Power ON OFF key for two 2 seconds to turn the Duo off and save the new settings 8 You may then turn the Duo back on to resume normal operation NOTE The Duo cannot be placed directly back into normal Duo Operating Instructions monitoring mode aft
51. his instrument is contained in the Duo Monitor Service Manual Part Number 0070 00 0604 02 For additional information or assistance please contact a local authorized representative CAUTION U S Federal Law restricts this device to sale by or on the order of a physician or other practitioner licensed by U S state law to use or order the use of this device Patents This device is covered under one 1 of more of the following U S patents and any foreign equivalents 4 621 643 4 700 708 4 770 179 4 869 254 4 653 498 4 928 692 4 934 372 5 078 136 5 482 036 5 490 505 5 632 272 5 685 299 5 758 644 5 769 785 6 157 850 6 206 830 4 802 486 5 351 685 5 421 329 5 485 847 5 533 507 5 577 500 5 803 910 5 853 364 5 865 736 6 263 222 6 083 172 Re 35 122 Possession or purchase of this device does not convey any express or implied license to use this device with replacement parts which would alone or in combination with this device fall within the scope of one 1 or more of the patents related to this device Warnings Precautions And Notes Please read and adhere to all warnings precautions and notes listed here and in the appropriate areas throughout this manual A WARNING is provided to alert the user to potential serious outcomes death injury or serious adverse events to the patient or the user A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the de
52. iance of the Duo monitor with the Medical Device Directive MDD 93 42 EEC Introduction Symbols This page intentionally left blank x 0070 10 0603 0 1 Duo Operating Instructions in General Product Description 1 1 Overview The Duo is an NIBP spot check monitor that is intended for use in health care settings on adult and pediatric patients requiring immediate and constant clinical supervision Its design facilitates rapid accurate NIBP measurement The parameters that can be monitored with the Duo are Non Invasive Blood Pressure Pulse Rate and SpO Optional The Duo can be powered by an AC connection or rechargeable Lithium lon battery Additionally the unique carrying handle light weight design and compact size make Duo extremely portable The Duo can be carried by its handle mounted on a rolling stand or used as a tabletop device NOTE The Duo can be used in the presence of a defibrillator discharge and during electrosurgery NOTE If it is stored or used outside of the specified environmental conditions the Duo may not meet performance specifications see the Appendix on page 5 1 Duo Operating Instructions 0070 10 0603 01 Controls and Indicators 1 2 1 2 1 Controls and Indicators Front Panel General Product Description The Duo front panel is the main user interface providing the digital LED display keypad and connector panel
53. iatric Mode 2 digits unspecified PATIENT SIZE SATURATION RANGE 70 to 100 0 69 Adult Mode 3 digits unspecified Pediatric Mode 3 digits unspecified 20 seconds to 95 of final step change of SpO value from 60 to 95 at 75 bpm Post averaging time is set at 8 seconds Low Perfusion Performance LOW PERFUSION CONDITIONS PULSE AMPLITUDE gt 0 02 Pulse Rate Resolution Update Rate Range and Accuracy PATIENT SIZE Adult Pediatric Duo Operating Instructions SATURATION PULSE RATE TRANSMISSION ACCURACY ACCURACY gt 5 2 digits 3 digits 1 bpm 1 Hz PULSE RATE RANGE ACCURACY NO MOTION DURING MOTION CONDITIONS CONDITIONS 25 240 bpm 3 digits 5 digits 0070 10 0603 01 5 7 Patient Parameter Specifications Appendix Masimo Reference Footnotes The Masimo MS 7 pulse oximeter with LNOP Adt sensors have been validated for no motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies in the range of 70 to 100 SpO against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population The Masimo MS 7 pulse oximeter with LNOP Adt sensors has been validated for motion accuracy in human blood studies on healthy adult volunteers in induced hypoxia studies while performing rubbing and tapping motions at 2 to 4 Hz At an amplitude of 1 to 2 cm and no
54. iding non invasive systolic diastolic and mean blood pressure measurements in Pediatric and Adult modes using a blood pressure cuff The NIBP function is in accordance with the requirements of EN 1060 1 EN 1060 3 and ANSI AAMI SP 10 1992 Systolic Pressure Measurement Accuracy Mean error is less than 5 mmHg Standard Deviation is less than 8 mmHg Range ADULT MODE PEDIATRIC MODE 40 to 255 mmHg 40 to 200 mmHg Diastolic Pressure Measurement Accuracy Mean error is less than 5 mmHg Standard deviation is less than 8 mmHg Range ADULT MODE PEDIATRIC MODE 10 to 210 mmHg 10 to 150 mmHg Blood pressure measurements determined with this device are equivalent to those obtained by a trained observer using the cuff stethoscope auscultation method within the limits prescribed by ANSI AAMI SP 10 1992 Electronic or automated sphygmomanometers NOTE Mean Arterial Pressure MAP is defined as Mean Pressure 1 Mean Pressure determined from the oscillometric profile Mean Pressure 2 2 diastolic systolic 3 Mean Pressure Displayed Mean Pressure 1 Mean Pressure 2 2 Static Pressure Measurement Range O 325 mmHg Static Accuracy 3 mmHg over the entire range 0070 10 0603 01 Duo Operating Instructions Appendix 5 2 5 5 2 6 5 2 6 1 5 2 6 2 5 2 6 3 5 2 6 4 5 2 6 5 Patient Parameter Specifications Pulse Rate from NIBP Accuracy 1 bpm Resolution 1 bpm Range ADULT MODE
55. ions included with each SpO sensor and cable for proper placement and use 1 Select an SpO sensor that is appropriate for the size of the patient 2 Attach the SpO sensor to the patient s finger 3 Orient the connector so that the Masimo SET logo is pa i Aena facing upward Plug the connector into the SpO AS I Magno l receptacle on the front panel of the Duo The SpO o J MO measurement will display when the Duo detects Al 2 that the sensor is connected to the patient m a J TR ERNIA A These results are updated once every second and can display for a maximum of 2 minutes during continuous SpO measurement NOTE To disconnect the cable from the Duo squeeze the tabs on the sides of the connector and then pull it straight out Duo Operating Instructions 0070 10 0603 01 2 11 Routine Operation 2 3 3 2 2 12 Operation Nellcor SpO Nellcor provides a family of sensors suitable for a wide variety of clinical settings and patients Specific sensors have been developed for a variety of patient sizes CAUTION When equipped with Nellcor SpO2 use only Nellcor oxygen sensors and cables Use of other oxygen sensors may cause improper oximeter performance The DS 100A Finger Clip Sensor is shipped with the Nellcor version of the Duo This sensor is a combination sensor cable connector that attaches to the monitor NOT
56. late blood beginning to flow through the artery will cause the artery to pulsate These pulsations are transmitted through the blood pressure cuff and connecting hose to the pressure transducer in the NIBP module The output of the pressure transducer is an analog pulsating signal This signal is filtered by a high pass filter and then amplified The amplified analog signal is then converted to a digital signal The digital signal is then processed to determine the systolic diastolic and mean pressures as well as heart rate Duo Service Manual 0070 10 0604 01 Hardware Overview 1 2 5 Theory of Operation SpO Overview Pulse oximetry SpO measurement is used to determine the oxygen saturation level of the patient s blood The SpO numeric display indicates the amount of hemoglobin that has bonded with oxygen molecules to form oxyhemoglobin By analyzing the pulse in the fingertip using specified algorithm and consulting the clinical data table we can obtain the SpO5 value The SoO gt sensor consists of two LEDs one red and one infrared and a photodetector The two LEDs are alternately lighted at a precise frequency When the capillary vessels of the fingertip are filled a certain amount of light from the LEDs is absorbed by blood in the capillaries The remaining red and infrared light is then picked up by the photodetector The photodetector detects the varying light intensity due to pulsations and transmits the changing
57. light intensity in the form of changing electronic signals The amount of light absorption is then compared to the known fixed LED output by the SpO board The pulse rate is counted and the SpO value is determined by using an algorithm contained in the software on the SpO board 0070 10 0604 0 1 Duo Service Manual 2 0 2 1 Duo Service Manual Calibration and Performance Verification Introduction The following procedures are provided to verify the proper operation of the Duo monitor A menu driven interface is used to execute all verification tests Performance tests should be performed at least once per year and after any preventive maintenance or repair has been performed 0070 10 0604 01 Warnings and Guidelines 2 2 2 3 Calibration and Performance Verification Warnings and Guidelines In the event that the instrument cover is removed observe the following warnings and guidelines 4 Do not short component leads together Perform all steps in the exact order they are given Use extreme care when reaching inside the opened instrument Do not contact exposed metal parts that may become live Read through each step in the procedure so it is understood prior to performing the step Test Equipment and Special Tools Required 0 300 mmHg Digital or Mercury manometer with bulb and valve 500 cc Test Chamber Dummy Cuff P N 0138 00 0001 03 DVM SpO simulator NIBP simulator Safety Analyze
58. mands from the Keypad The power supply board provides 3 3 vdc and 12 vdc to the CPU board These voltages are monitored by an A D converter located on the CPU board The CPU also controls an integral LED display array and indicator LEDs The main processor has a built in serial port that is used to load software The processor also uses a FPGA to communicate with the NIBP Module the optional SpO module SpO presence is detected via a jumper on JP1 and to drive the LED arrays and indicators 0070 10 0604 01 Duo Service Manual Theory of Operation A D Converter RTC E PROM L l Hardware Overview Keypad CPU To To SpO2 NIBP Module Module lt FPGA ly T User Interface To p External Serial Interface Interface FIGURE 1 4 CPU Display Board Block Diagram CPU Board Test Points Location Function VPP in 12 vdc power supply VDD in 3 3 vdc power supply BV Battery voltage 5B in 5 vdc power supply ADV 10 5 vdc ADV out RST CPU reset line XT2 11 0592 MHz clock 1 2 4 NIBP Module Overview LED Array Display Indicator LEDs The Duo monitor determines non invasive blood pressure using the oscillometric method The blood pressure cuff is inflated until the pressure in the cuff is sufficient to block blood flow in the brachial artery As the cuff begins to def
59. n Isolated PI Power P2 Control Board Board To P1 on Main Isolated P1 Power P2 Control Board Board External Interface Serial RS2320TIL PS Interface Inverter gt PI P2 P3 Main SONE Control Supply Board Board Battery EL E P4 Fan Fan P2 Drive Pl Board FIGURE 4 1 Module Interconnection Duo Service Manual 0070 10 0604 0 I Nellcor J2 SpO2 JI Module Pl NIBP Module SpO2 Sensor SpO2 Sensor m Cuff Troubleshooting Guide Troubleshooting Guide Error Codes and Solutions MESSAGE PROBLEM REASON EO NIBP Self Test Error E02 NIBP Communications Error E03 Loose Cuff E04 Air Leak EOS Air Pressure Failure EO6 Successful Pneumatic Test EO7 Pneumatic Test Failed Pneumatic Leak EO8 Weak Signal EO9 Range Exceeded E10 Excessive Motion Signal Saturated Ell Over Pressure E12 NIBP System Failure E13 NIBP Time Out E14 NIBP Illegally Reset E15 NIBP Reset Failed E16 NIBP Communications CRC Error EIZ NIBP Patient Size Change Error E20 Masimo SpO2 Interference E2 1 Masimo SpO Low Perfusion E22 Masimo SpO Too Much Light E23 Masimo SpO Unrecognized Sensor E24 Masimo SpO Communication Error E25 Masimo SpO Board Fault E26 Masimo SpO Sensor Fault E28 Masimo SpO Timeout E29 Masimo SpO Low Signal IG 0070 10 0604 0 1 Repair Information SOLUTION NIBP Module hardware failure Communications with NIBP Module have f
60. n invasive measurement of the amount of oxygen attached to the hemoglobin in red blood cells also known as oxyhemoglobin saturation SpO is the estimation of arterial oxygen saturation This term is used interchangeably with SaO This value is displayed in the SpO parameter tile Traditional pulse oximetry determines SpO by passing red and infrared light into a capillary bed and measuring changes in light absorption during the pulsatile cycle Red and infrared lightemitting diodes LEDs in oximetry sensors serve as the light sources a photodiode serves as the photo detector Traditional pulse oximetry assumes that all pulsations in the light absorbance signal are caused by oscillations in the arterial blood volume This also assumes that the blood flow in the region of the sensor passes entirely through the capillary bed rather than through any arterio venous shunts Performance Considerations To ensure optimal SpO9 measurement use an appropriate sensor apply it as directed and observe all warnings and cautions Sensors are designed for specific sites on patients with designated weight ranges To select the appropriate sensor consider the patient s weight level of activity adequacy of perfusion available sensor sites and the sterility requirement If excessive ambient light is present cover the sensor site with opaque material Failure to do so may cause inaccurate measurements Light sources that can affect performance i
61. n repetitive motion between 1 to 5 Hz At an amplitude of 2 to 3 cm in induced hypoxia studies in the range of 70 to 100 SpO against a laboratory co oximeter and ECG monitor This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population 3The Masimo MS 7 pulse oximeter has been validated for low perfusion accuracy in bench top testing against a Biotek Index 2 simulator and Masimo s simulator with signal strengths of greater then 0 02 and a transmission of greater than 5 for saturations ranging from 70 to 100 This variation equals plus or minus one standard deviation Plus or minus one standard deviation encompasses 68 of the population NOTE The sensor measurement wavelengths are nominally 660 nm for the red LED and 940 nm for the infrared LED Maximum optical power output for LED is 4 mW 5 8 0070 10 0603 01 Duo Operating Instructions Appendix Patient Parameter Specifications SETO Nellcor SpO Performance Requirements Sp0 Sensor Compatibility OxiMax series MAX A MAX AL MAX P MAX FAST MAXR OxiCliq A OxiCliq P D YS D YSE D YSPD DS 100A OXLA N and OXI P I Display Range 1 100 Resolution 1 Saturation Accuracy SENSOR ACCURACY MAX A MAX AL MAX P MAX 70 to 100 2 digits and MAX FAST Below 70 unspecified OxiCliq A OxiCliq P and OxiClig 70 to 100 2 5 digits Below 70 unspecified D YS DS 100A OXI A N and 70 to 100
62. nclude surgical lights especially those with a xenon light source bilirubin lamps fluorescent lights infrared heating lamps and direct sunlight In the event that a reading is unobtainable or inaccurate consider the following e If the patient is poorly perfused try applying the sensor to another site such as a different finger or toe e Ensure that the sensor is properly aligned and securely applied e Use a new sensor e Move the sensor to a less active site e Use a type of sensor that tolerates some patient motion e Ensure that the sensor and site are clean non greasy Nail polish and fungus should be removed Calibration The oximetry sub system incorporates automatic calibration mechanisms No other calibration is required Duo Operating Instructions 0070 10 0603 0 1 2 9 Routine Operation CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION Operation Do not place the SpO2 sensor on an extremity with an invasive catheter or blood pressure cuff in place Tissue damage or inaccurate measurement may be caused by incorrect SpO2 sensor application or use such as wrapping too tightly applying supplemental tape failing to inspect the sensor site periodically or failing to position appropriately Carefully read the SpO2 sensor directions and all precautionary information before use Inaccurate SpO2 measurements may be caused by e incorrect sensor application or use
63. ode from Maintenance Mode or when it is connected to AC power Changing the power source from battery to AC while in Standby Mode causes the Duo to automatically return to Normal Monitoring Mode To indicate that the Duo has entered Standby Mode the following will occur e The number eight 8 will display in the first LED position of the Information Codes tile and will then cycle through each of the three remaining LED positions of that tile Duo Operating Instructions 0070 10 0603 01 Modes of Operation 2 1 3 2 1 4 Operation When any of the events listed in the following table occur an internal Standby Mode counter is reset to zero and started The Duo enters Standby Mode after a preset time period for specitic events as follows TIME PERIOD TO ENTER EVENT STANDBY MODE Switching from AC power to battery power 3 minutes Any key press 3 minutes The determination of an NIBP value 2 minutes The acquisition point of SpO7 data 3 minutes In Standby Mode the only key that is active is Power ON OFF When it is pressed for any duration of time the Duo returns to Normal Monitoring Mode NOTE The Duo cannot be powered OFF while in Standby Mode It must return to Normal Monitoring Mode before it can be powered OFF Auto Shutoff Mode This feature is also designed to save power while the Duo is operating from the internal battery When the Duo has been in Standby Mode for 13 minutes it will automatically power OFF See
64. of 10 box of 10 box of 10 box of 10 box of 5 box of 10 0070 10 0603 01 PART NUMBERS 0683 14 0001 01 0683 14 0002 01 0683 14 0003 01 0683 14 0004 01 0683 14 0005 01 0683 14 0006 01 0683 14 0007 01 Disposable NIBP cuff Small Adult 18 to 26cm quick connect 0683 14 000201 Disposable NIBP cuff Adult 25 to 35 cm quick connect 0683 14 0003 01 Disposable NIBP cuff Large Adult 33 to 47cm quick connect 0683 14 0004 01 Disposable NIBP cuff Thigh 46 to 66cm quick connect 0683 14 0005 01 Disposable NIBP Cuff Adult Long 25 35 cm quick connect 0683 14 000601 Disposable NIBP Cuff Large Adult Long 33 47 cm quick connect box of 10 Duo Operating Instructions Accessories 4 4 2 3 SpO Accessories Masimo SET Sensors DESCRIPTION LNOP Adt Adult Single Patient Adhesive Sensor Box of 20 LNOP Pdt Pediatric Single Patient Adhesive Sensor Box of 20 LNOP DCI Adult Reusable Finger Sensor PATIENT SIZE gt 30 kg 10 to 50 kg gt 30 kg Masimo SET Cables and Accessories DESCRIPTION SpO cable PCO8 8 2 4 m SpO cable PC12 12 3 7 m Clothing Clips pkg of 5 Nellcor OxiMax Cables and Accessories Optional Accessories PART NUMBERS 0600 00 0043 01 0600 00 0044 01 0600 00 0047 PART NUMBER 0012 00 1099 01 0012 00 1099 02 0600 00 0084 DESCRIPTION PART NUMBER Durasensor DS100A Adult Reusable Sens
65. or 0600 00 005 1 AA AA e a OOO RARA A A CI DOC 10 OxiMax SpO Cable 0012 00 1464 Sensors must be reordered through Nellcor Miscellaneous Accessories DESCRIPTIONS Battery Lithium lon AC Power Cord 110 Volt AC Power Cord 220 Volt AC Power Cord UK 240 Volt Duo Rolling Stand Kit Duo Mounting Bracket for rolling stand Duo Operating Instructions 0070 10 0603 01 PART NUMBER 0146 00 0079 0012 25 0001 0012 25 0002 0012 25 0003 DUOROLLSTD 0406 00 0857 01 Optional Accessories Accessories This page intentionally left blank 4 4 0070 10 0603 01 Duo Operating Instructions so Appendix 5 1 Specifications The Duo monitor complies with the following standards 5 1 1 Safety Standards IEC 60601 1 1988 Medical Electrical Equipment A1 1991 A2 1995 Part 1 General Requirements For Safety EN 60601 1 1990 A1 1993 A2 1995 A13 1995 UL 60601 1 2003 Medical Electrical Equipment Part 1 General Requirements for Safety CSA Standard C22 2 Medical electrical Equipment No 601 1M90 General Requirements for Safety IEC 60601 1 2 2001 Medical Electrical Equipment EN 60601 1 2 2001 Part 1 2 General Requirements for Safety EMC Requirements and Tests IEC 60601 1 4 1996 Collateral Standard Programmable Electrical EN60601 1 4 1996 A1 1999 Medical Systems IEC 60601 2 49 2001 Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment Duo Operating Inst
66. out lt 10 ms NOTE Mains power quality should be that of a typical commercial or hospital environment If the user of the Duo requires continued operation during power mains interruptions it is recommended that the Duo be powered from an uninterruptible power supply or a battery AC Slow Sags and Surge 90 V to 150 V for 500 ms AC Steady State Voltage 95 132 V AC battery switching below 95 V Quasi static Fields 500 2000 V m sweep at 0 5 Hz sine Magnetic Emissions MIL STD 461D RE101 30 Hz to 100 kHz O 7 cm 0070 10 0603 01 Duo Operating Instructions Appendix 5 3 Warranty Statements Warranty Statements Mindray DS USA Inc warrants that components within the monitor unit will be free from defects in workmanship and materials for the number of years shown on the invoice Under this extended warranty Mindray DS USA Inc will repair or replace any defective component at no charge for labor and or materials This extended warranty does not cover consumable items such as but not limited to batteries displays external cables and sensors Recommended preventative maintenance as prescribed in the Service Manual is the responsibility of the user and is not covered by this warranty Except as otherwise provided herein the terms conditions and limitations of Mindray DS USA Inc s standard warranty will remain in effect USA Canada Mexico and Puerto Rico Mindray DS USA Inc warrants that its products
67. poration 1 6 0070 10 0603 01 Duo Operating Instructions General Product Description Controls and Indicators 1 2 2 Rear Panel The rear panel provides a general information label a serial port an equipotential lug an AC receptacle and a mounting alignment slot os y Lee E V 100 240 1EC601 1 1988 A 07 04 CA C22 2 No 601 1 90 Hz 60 50 UL2601 1 1997 V AA SS AA JOBOUDL FIGURE 1 6 Rear Panel 1 Serial Port This is used to connect optional modules 2 Equipotential Lug Ko The equipotential lug provides equipotential grounding for hospital equipment NOTE Ensure that when connecting external devices to the unit all equipotential terminals are connected 3 AC Receptacle This is the connector for the AC power cord NOTE The power supply and battery charger if the battery is installed are active any time AC power is supplied regardless of whether the monitor is ON or OFF 4 Mounting Alignment Slot This is used to align the Duo with the mounting plate on the optional rolling stand Duo Operating Instructions 0070 10 0603 01 1 7 Controls and Indicators 1 2 3 General Product Description Bottom Panel The battery compartment and the mounting
68. r Dempsey model 431 or equivalent Oscilloscope Laptop or PC software upgrade 0070 10 0604 0 1 Duo Service Manual Calibration and Performance Verification Calibration and System Checks 2 4 2 4 1 2 4 2 2 4 3 Duo Service Manual Calibration and System Checks Device Appearance and Installation Checks Inspect the Duo monitor to ensure that The outer housing is clean and has no scratches or cracks When the device is gently shaken there are no loose components All keys are smooth and free for operation Labels are complete clean and accurate All connectors accessory modules are installed securely Ensure monitor is securely fastened to its rolling stand if used Maintenance Functions Non Monitoring Modes When entering the maintenance functions non monitoring mode the monitor will perform a self test however the verification of functional LEDs will not be displayed In the maintenance mode the standby mode will not be active In the maintenance mode the auto shutoff will activate if no key is pressed for a period of 15 minutes Unit of Measure Mode The unit of measure mode is used to change between mmHg and kPa To access the Unit of Measure mode Pep gt Turn the monitor off Simultaneously press and hold the POWER and CLEAR buttons Press the CLEAR button to cycle through the unit of measure choices Once the desired unit of measure is displayed turn the Duo off to save that setting
69. range Interference may occur in the vicinity of equipment marked with the following symbol 0 At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theo retically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electro magnetic site survey should be considered If the measured field strength in the location in which the Duo is used exceeds the applicable RF compliance level above the Duo should be observed to verify normal opera tion If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the Duo b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Duo Operating Instructions 0070 10 0603 01 Patient Parameter Specifications Appendix TABLE 5 4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE DUO The Duo is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Duo can help prevent electromagnetic interf
70. rating Instructions Appendix ISO 3744 1994 ANSI AAMI ISO 10993 10 1995 ANSI AAMI ISO 10993 5 ANSI AAMI ISO 10993 1 1997 ANSI AAMI SP 10 1992 EN 1041 1998 EN 980 1996 A1 1999 A2 2001 IEC 878 1998 ISO 1000 1992 A1 1998 5 1 5 Specifications Acoustics Determination of Sound Power Levels of Noise Sources Using Sound Pressure Biological evaluation of medical devices Part 10 Tests for irritation and sensitization Biological evaluation of medical devices Part 5 Cytotoxicity Biological evaluation of medical devices Part 1 Evaluation and testing Electronic or Automated Sphygmomanometers Information Supplied by the Manufacturer with Medical Systems Graphical Symbols for Use in Labeling of Medical Devices Graphical Symbols for Electrical Equipment in Medical Practice SI units and recommendations for the use of their multiples and of certain other units United States Food and Drug Administration Documents Reviewer Guidance for Pre market Notification Submission November 1993 draft Guidance Non Invasive Blood Pressure NIBP Monitor Guidance March 10 1997 Non Invasive Pulse Oximeter General Guidance draft September 7 1992 Duo Operating Instructions 0070 10 0603 01 5 3 Patient Parameter Specifications Appendix 5 2 5 2 1 5 2 2 5 2 3 5 2 4 Patient Parameter Specifications NIBP Sub System Performance Characteristics The NIBP function is capable of prov
71. recautions and notes listed here and in the appropriate areas throughout this manual A WARNING is provided to alert the user to potential serious outcomes death injury or serious adverse events to the patient or the user A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the device They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury but about which the user should be aware Cautions are also provided to alert the user to adverse effects on this device of use or misuse and the care necessary to avoid such effects A NOTE is provided when additional general information is applicable 0070 10 0604 01 iii Introduction Warnings Precautions And Notes This page intentionally left blank iv 0070 10 0604 01 Duo Service Manual 10 Theory of Operation 1 1 Introduction The Duo is a compact lightweight portable patient monitor intended for monitoring the following vital signs blood pressure SpO optional and pulse rate on adult and pediatric patients The Duo monitor can be powered by either the internal rechargeable Lithium lon battery or external 100 240 volt 50 60 Hz AC Duo Service Manual 0070 10 0604 01 Hardware Overview 1 2 1 2 1 AC Input
72. rts Listing 3 2 Parts Listing REF NUMBER PART NUMBER 1 0211 00 0146 2 0380 00 0475 3 0441 00 0107 4 067 1 00 0045 5 021 1 00 0145 6 067 1 00 0044 7 02 13 00 0032 8 0380 00 0472 8A 0380 00 0473 9 0380 00 0476 10 0012 00 1595 11 0671 00 0246 12 0211 00 0143 13 0671 00 0243 14 0012 00 1474 15 0671 00 0247 16 0671 00 0242 16a 0671 00 0066 17 0012 00 1457 17a 0012 00 1661 18 0386 00 0308 19 0104 00 0037 20 0671 00 0063 21 067 1 00 0043 22 0380 00 048 23 0380 00 0474 24 0346 00 0052 25 001 2 00 1592 26 0348 00 02 16 27 0213 00 4014 28 0386 00 0310 29 0380 00 047 1 30 0367 00 0084 31 0211 00 0147 32 0334 00 1603 03 33 0348 00 0202 34 0380 00 0480 01 35 0380 00 0480 02 36 0380 00 0480 03 37 0380 00 0480 04 N S Not Shown 0070 10 0604 01 Parts DESCRIPTION Housing Screw metric panhead Rear Housing Chassis Power Supply Board Metric Panhead Screw CPU Display Board Self Tapping Screw Nellcor Connector Shroud Masimo Connector Shroud Front Housing SpO Power Cable Masimo Isolated Power Board Screw Masimo SpO Board Masimo Flex Cable Nellcor Isolated Power Board Nellcor SpO Board Nell 3 SpO3 Board Nellcor Flex Cable Nellcor Flex Cable SpO Mounting Plate NIBP Module Fan Driver Board Battery Connector Board Battery Latch Battery Door Battery Door Tether Fan with cable Fan Gasket Screw Fan Mounting Plate Filler Panel Handle Handle Screw metric panhead Rear Label Lower
73. ructions 0070 10 0603 0 1 Specifications 5 1 2 5 1 3 5 1 4 Safety Designations Type of protection against electric shock Degree of protection against electric shock Supply Connection Mode of Operation Protection Against Hazards of Explosion Protection Against Ingress of Liquid s Degree of electrical connection between equipment and patient Degree of Mobility Appendix Class 1 with internal electric power source Where the integrity of the external protective earth ground in the installation or its conductors is in doubt the equipment is operated from its internal electric power source batteries NIBP Type BF defibrillation protected SpO Type BF Monitor Type B equipment 100 240 VAC 10 50 60 Hz 3 Hz 0 7 0 4 Amps 7 2 VDC Internal Battery Continuous Not protected Ordinary Not protected Ordinary IPXO per IEC 60529 Equipment designed for non electrical connection to the patient Transportable Hazard Analysis Risk Management EN ISO1497 1 2000 Performance Accuracy EN 865 1997 EN 1060 1 1995 EN 1060 3 1997 0070 10 0603 0 1 Medical Devices Application of risk management analysis to medical devices Pulse Oximeters Particular Requirements Specification for Non invasive Sphygmomanometers Non invasive Sphygmomanometers Supplementary Requirements for Electromechanical Blood Pressure Measuring Systems Duo Ope
74. t are damaged or have deteriorated 0070 10 0603 0 1 Duo Operating Instructions User Maintenance 3 3 2 3 3 2 1 Care and Cleaning of Accessories Care and Cleaning of Reusable Cuffs NOTE Accuracy of cuff pressure transducers indicators is to be verified at intervals specified by the manufacturer Reusable Cuffs with Bladders Take out the bladder before cleaning and disinfecting the cuff Cleaning The cuff can be hand washed or machine washed in warm water or with mild detergent The bladder can be cleaned with a damp cloth Air dry the cuff thoroughly after washing NOTE Machine washing may shorten the service life of the cuff Disinfection The cuff may be disinfected with a damp cloth with 70 isopropanol and water lt may also be disinfected with ultraviolet The bladder can only be disinfected with ultraviolet NOTE Prolonged use of disinfectant may cause discoloration of the cuff Replace the bladder after cleaning and disinfecting the cuff as follows Place the bladder on the top of the cuff as the figure shows Roll the bladder lengthwise and insert it into the large opening See the figures below Hold the hose and the cuff and shake the complete cuff until the bladder is in position A ON Thread the hose from inside the cuff and out through the small hole under the internal flap CAUTION Do not dry clean the cuff Do not press the cuff with a hot iron Do not use detergent and disinfect
75. t chamber to 50 mmHg and verify the Duo reading agrees with the manometer 3 mmHg Using the bulb increase the pressure to 200 mmHg and verify the Duo reading agrees with the manometer 3 mmHg Pneumatic Leak Test Connect the 500 cc test chamber to the NIBP fitting on the Duo monitor under test From the NIBP Calibration Mode code 525 momentarily press the CLEAR button on the Duo keypad The Duo will then switch to the Pneumatic Test Mode and will display message code 550 in the Information Codes window Momentarily press the NIBP START STOP button to start the leak test The Duo under test will automatically pressurize the test chamber to approximately 180 mmHg After approximately 20 seconds the Duo under test will vent the pressure in the test chamber and display a message code E06 Pass or EO7 Fail in the systolic window Dynamic Repeatability Test Restart unit and allow it to enter normal operating mode Use polyurethane tubing to connect the Duo monitor to a calibrated NIBP simulator and the 500 cc test chamber dummy cuff via a T fitting Select Adult patient size for both the Duo under test and the NIBP simulator Select a target simulated blood pressure within the normal range on the simulator Take 10 successive NIBP readings and compare the systolic diastolic mean and heart rate readings for consistency Readings should not deviate more than 5 mmHg for the NIBP readings and 2 bpm or 2
76. the SpO5 Interface pcb from the stand offs Sp0 Board Removal 1 Remove three 3 5mm hex stand offs from the SpO Board 2 Remove one 1 3 x 6 mm Phillips panhead machine screw from the SpO Board 3 Lift the SpO gt Board from the mounting bracket CPU Display Board Removal 1 Remove four 4 3 x 6 mm Phillips panhead machine screws from the corners of the CPU Display Board 2 Lift the CPU Display Board from the Front Housing NIBP Module Removal 1 Remove four 4 3 x 6 mm Phillips panhead machine screws from the corners of the NIBP module frame 2 Lift the NIBP module from the battery housing frame 0070 10 0604 0 1 Duo Service Manual Repair Information 4 3 7 Duo Service Manual Disassembly Instructions Power Supply Removal 1 Remove the battery cable from P1 on the power supply PCB 2 Remove four 4 3 x 6 mm Phillips panhead machine screws from the corners of the power supply PCB 3 Remove one 1 3 x 6 mm Phillips panhead machine screw from the line power entry connector 4 Slide the Power Supply pcb towards the bottom open end of the battery housing frame until it can go no farther 5 Lift the power supply PCB from the battery housing frame Use care to avoid breaking the positioning tab from the line power entry connector 0070 10 0604 01 4 7 0070 10 0604 0 1 Revision F July 12 2010 Mindray DS USA Inc e 800 MacArthur Boulevard e Mahwah NJ 07430 e USA Dom Customer Ser
77. the previous subsection for the conditions under which the Duo can enter Standby Mode Maintenance Mode Maintenance Mode is a general reference to the following group of non monitoring modes e Unit of Measure Mode e Version Mode e NIBP Calibration Mode e NIBP Pneumatic Test Mode Of the four 4 modes listed only Unit of Measure Mode is intended for the clinician and is described in section 2 2 1 The remaining modes are strictly intended for the use of a biomedical technician or other qualified service person If any of these modes is inadvertently entered Normal Monitoring Mode can be reestablished by powering OFF and restarting the Duo 0070 10 0603 01 Duo Operating Instructions Operation Initial Set Up ZA Initial Set Up This section provides step by step instructions for initial set up of the Duo 1 Confirm that the proper voltage is available for connecting the Duo to AC power 2 Install the battery as follows e Remove the battery compartment door shown in FIGURE 2 1 Battery Compartment Door Battery Locking Mechanism FIGURE 2 1 Battery Compartment e The battery compartment is shaped so that the battery can only be inserted in the proper orientation Disengage the battery locking mechanism by moving its plastic tab away from the center of the compartment see FIGURE 2 1 Insert the new Lithium lon battery with its contacts shown in FIGURE 2 2 facing the rear of the compartment Contacts
78. time information code from the current display of the parameter tiles When the data is deleted the NIBP cuff inflation pressure is returned to the default value for the selected patient size e When a measurement for NIBP is currently in progress this key is not active c Patient Size e This key is used to set the patient size to either Adult or Pediatric While in normal monitoring mode each press of this key toggles between the two sizes When the Duo is powered OFF the current patient size setting is maintained e When a measurement for NIBP is in progress this key is not active d NIBP Start Stop e This key is used to start an NIBP measurement and to stop an NIBP measurement that is already in progress Duo Operating Instructions 0070 10 0603 0 1 1 5 Controls and Indicators General Product Description 3 Connector Panel gt How 7 SS _ 4 OH T A 4 yy LA FIGURE 1 5 Connector Panel a NIBP Pneumatic Fitting e This Rectus Quick Connect pneumatic fitting is used to attach the NIBP hose to the Duo b SpO Receptacle optional e This receptacle is used to attach the SpO sensor to the Duo The two versions of SpO technology that are available for use with the DUO are Masimo and Nellcor Quick Connect Pneumatic Fittings available from Rectus TEMA Cor
79. tions CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION Duo Operating Instructions Introduction A patient s skin is sometimes fragile i e on pediatric and geriatric patients or due to physiological conditions In these cases a longer duration between NIBP measurements should be considered to decrease the number of cuff inflations over a period of time In extreme cases a thin layer of soft roll or cotton padding may be applied to the limb in order to cushion the skin when the cuff is inflated This may affect NIBP performance and should be used with caution Please consult a physician for interpretation of blood pressure measurements A blood pressure measurement can be affected by the position of the patient and his her physiological condition as well as other factors such as patient movement Any condition that may affect the regularity and strength of arterial pressures such as patient movement cardiac arrhythmias restriction of hose etc will affect the accuracy and ability to measure the NIBP When cleaning SpO sensors do not use an excessive amount of liquid Wipe the sensor surface with a soft cloth dampened with a cleaning solution Do not subject the SpO sensor to autoclaving Do not use SpO sensors or cables that are damaged or have deteriorated Some disinfectants may
80. uction FIGURE 3 2 Masimo SpO gt Detail Duo Service Manual 0070 10 0604 0 1 3 3 Introduction Parts FIGURE 3 3 Nellcor SpO gt Detail 3 4 0070 10 0604 01 Duo Service Manual Parts Introduction FIGURE 3 4 Main Frame Duo Service Manual 0070 10 0604 01 3 5 Introduction Parts FIGURE 3 5 Rear Case Assembly 5 6 0070 10 0604 0 1 Duo Service Manual Parts Introduction FIGURE 3 6 Front Case Assembly Duo Service Manual 0070 10 0604 01 Introduction Parts FIGURE 3 7 Battery Connector Assembly Detail 3 8 0070 10 0604 0 1 Duo Service Manual Parts Introduction Screws mounting plate Ve Duo monitor Washers locking _ mounting plate Mounting screw for basket Utility basket Mounting screw for basket Casters Non locking Fi Casters locking N Washers locking Mounting bolts pole FIGURE 3 8 Duo Rolling Stand Replacement Parts Duo Rolling Stand DESCRIPTION PART NUMBER Duo rolling stand value DUOROLLSTD Duo monitor mounting kit 0406 00 0857 01 Casters Non locking 0401 00 0045 Casters Locking 0401 00 0046 Utility basket 0202 00 0166 Included in Duo monitor mounting kit Duo Service Manual 0070 10 0604 0 1 3 9 Pa
81. ulsations e electro surgical interference e placement of a sensor on an extremity that has a blood pressure cuff arterial catheter or intra vascular line e nail polish or fungus In certain situations in which perfusion and signal strength are low such as in patients with thick or pigmented skin inaccurately low SpO readings will result Verification of oxygenation should be made especially in patients with chronic lung disease before instituting any therapy or intervention Many patients suffer from poor peripheral perfusion due to hypothermia hypovolemia severe vasoconstriction reduced cardiac output etc These symptoms may cause a loss in vital sign readings If the SpO sensor or patient cable are damaged in any way discontinue use immediately To prevent damage do not soak or immerse the sensor in any liquid solution Do not attempt to sterilize When applying the SpO sensor to the patient ensure proper positioning alignment and skin integrity Exercise extreme caution with poorly perfused patients When equipped with Masimo SpO use only Masimo oxygen sensors and cables Use of other oxygen sensors may cause improper oximeter performance When equipped with Nellcor SpO use only Nellcor oxygen sensors and cables Use of other oxygen sensors may cause improper oximeter performance Use only Mindray DS blood pressure cuffs and hoses with the Duo 0070 10 0603 0 1 Duo Operating Instructions Precau
82. vice 1 800 288 2121 e Intl Customer Service 1 201 995 8000 e Dom Fax 1 800 926 4275 e Intl Fax 1 201 995 8680 e www mindray com Mindray Medical Netherlands B V e PO Box 26 e 3870 CA Hoevelaken e The Netherlands Tel 31 33 25 44 911 e Fax 31 33 25 37 621 Mindray UK Limited e 3 Percy Road e St John s Park e Huntingdon e Cambridgeshire PE29 6SZ e United Kingdom Tel 01480 416840 e Fax 01480 436588 Mindray Medical France SARL e Europarc Cr teil e 123 Chemin des Bassins 94035 Cr teil Cedex e France Tel 0 1 45 13 91 50 e Fax 0 1 45 13 91 51 Mindray Medical German GmbH e Zwischen den Bdchen 4 e 64625 Bensheim e Germany Tel 49 6251 17524 0 e Fax 49 6251 17524 20 Mindray Medical International Ltd e 2813 Office Tower Convention Plaza e No 1 Harbour Road e Wanchai e Hong Kong Tel 852 2793 5596 e Fax 852 2344 8824 0002 08 89 1 8
83. vice They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury but about which the user should be aware Cautions are also provided to alert the user to adverse effects on this device of use or misuse and the care necessary to avoid such effects A NOTE is provided when additional general information is applicable Duo Operating Instructions 0070 10 0603 01 iii Introduction Warnings Warnings WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING WARNING The Duo monitor is not intended for unsupervised continuous monitoring It is for spot check use only Maintain extreme caution when a defibrillator is in use avoiding contact with any part of the patient table or monitor Route cables neatly Ensure cables hoses and wires are away from patient s neck to avoid strangulation Keep floors and walkways free of cables to reduce the risk of tripping This monitor is not intended for use in an MR environment The Duo monitor is intended for hospital use under the direct supervision of a licensed health care practitioner Do not clean the monitor while it is ON and or connected to AC power The Duo should not be used adjacent to or stacked with other equipment If adjacent or stacked use is necessary the Duo should be observed to verify normal operation in the configuration in
84. which it will be used Operation of the Duo below the minimum amplitude or value of patient physiological signal may cause inaccurate results Use of accessories transducers and cables other than those specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the Duo It can also cause delayed recovery after the discharge of a cardiac defibrillator Do not use a damaged or broken unit or accessory Periodically check all cables e g AC line cord and patient connection cables for damage that may occur through normal use Replace cable if damaged in any way 0070 10 0603 01 Duo Operating Instructions Precautions Introduction Precautions CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION CAUTION Duo Operating Instructions Do not place the SpO sensor on an extremity with an invasive catheter or blood pressure cuff in place The use of portable and mobile RF communications equipment in the proximity of the Duo can affect the performance of this monitor Use only Mindray DS accessories with this product For a comprehensive listing of Duo Accessories refer to section 4 0 Accessories The patient size selection should be matched to the actual patient before monitoring begins Tissue damage or inaccurate measurement may be caused by incorrect SpO sensor application or use such as wrapping too tightly
85. will be free from defects in workmanship and materials for a period of one 1 year from the date of purchase except that disposable or one time use products are warranted to be free from defects in workmanship and materials up to a date one year from the date of purchase or the date of first use whichever is sooner This warranty does not cover consumable items such as but not limited to batteries external cables sensors cuffs hoses or mounts Mindray DS USA Inc will not be liable for any incidental special or consequential loss damage or expense directly or indirectly arising from the use of its products Liability under this warranty and the buyer s exclusive remedy under this warranty is limited to servicing or replacing at Mindray DS USA Inc s option at the factory or at an authorized Distributor any product which will under normal use and service appear to the Company to have been defective in material or workmanship No agent employee or representative of Mindray DS USA Inc has any authority to bind Mindray DS USA Inc to any affirmation representation or warranty concerning its products and any affirmation representation or warranty made by any agent employee or representative will not be enforceable by buyer This warranty is expressly in lieu of any other express or implied warranties including any implied warranty or merchantability or fitness and of any other obligation on the part of the seller Dam
86. yed Refer to Information Codes and Error Codes on page 2 13 for further information NOTE Pressing the Clear Next Patient key while there are no measurements in progress will reset the NIBP cuff inflation pressure to the default value for the selected patient size 1 Select a blood pressure cuff that is appropriate for the size of the patient Measure the circumference of the patient s limb for the best results NOTE Using a correctly sized cuff among other considerations has a direct bearing on the accuracy of the obtained NIBP measurements A cuff that is too narrow for the limb will result in erroneously high readings Selection of the cuff size should be based on the circumference of the patient s limb The design dimensions of the cuffs and their intended use are based on recommendations made by the American Heart Association CAUTION Use only Mindray DS blood pressure cuffs and hoses with the Duo 2 Attach the NIBP cuff to the NIBP extension hose 3 Attach the NIBP extension hose to the NIBP pneumatic fitting on the Duo 4 Apply the cuff to the patient as shown in FIGURE 2 3 Ensure that the cuff is deflated and lies directly against the patient s skin The cuff should fit snugly There should be no clothing between the patient s skin and the cuff CAUTION The cuff must be properly applied to the patient s limb before inflating If it is inflated without being securely wrapped damage fo the cuff can result F

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