Mindray Datascope Duo Service manual

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Operation/Service Manual

Operating Instructions

Duo™ is a U.S. trademark of Mindray DS USA, Inc.

Navigator

™

Masimo SET

Nellcor

and OxiMax® are U.S. registered trademarks of Nellcor Puritan Bennett Inc.

is a U.S. trademark of Mindray DS USA, Inc.

, LNOP® and CleanShield® are U.S. registered trademarks of Masimo Corp.

form without permission of Mindray DS USA, Inc.

0070-10-0603-01 Duo™ Operating Instructions

Tabl e o f Co nt en ts

Foreword....................................................................................................................................................... iii

Warnings, Precautions And Notes ....................................................................................................................iii

Warnings ......................................................................................................................................................iv

Precautions ....................................................................................................................................................v

Notes ............................................................................................................................................................viii

Indication for Use ........................................................................................................................................... viii

Unpacking ..................................................................................................................................................... viii

Symbols.........................................................................................................................................................ix

General Product Description.............................................................................................. 1 - 1

Overview....................................................................................................................................................... 1 - 1

Controls and Indicators.................................................................................................................................... 1 - 2

Front Panel ............................................................................................................................................. 1 - 2

Rear Panel .............................................................................................................................................. 1 - 7

Bottom Panel........................................................................................................................................... 1 - 8

Operation......................................................................................................................... 2 - 1

Modes of Operation........................................................................................................................................ 2 - 1

Normal Monitoring Mode......................................................................................................................... 2 - 1

Standby Mode ........................................................................................................................................ 2 - 1

Auto Shutoff Mode................................................................................................................................... 2 - 2

Maintenance Mode ................................................................................................................................. 2 - 2

Initial Set-Up................................................................................................................................................... 2 - 3

Setting the Units of Measure (Units of Measure Mode).................................................................................. 2 - 4

Routine Operation........................................................................................................................................... 2 - 6

NIBP Measurement .................................................................................................................................. 2 - 6

Pulse Rate Measurement ........................................................................................................................... 2 - 8

Measurement (Optional).................................................................................................................. 2 - 9

SpO

Information Codes and Error Codes .................................................................................................................. 2 - 13

Information Codes ................................................................................................................................... 2 - 14

Error Codes ............................................................................................................................................ 2 - 16

User Maintenance............................................................................................................. 3 - 1

Introduction.................................................................................................................................................... 3 - 1

Care and Cleaning of the Monitor .................................................................................................................... 3 - 2

Care and Cleaning of Accessories .................................................................................................................... 3 - 2

Sensors ......................................................................................................................................... 3 - 2

SpO

Care and Cleaning of Reusable Cuffs ........................................................................................................ 3 - 3

Battery Replacement and Maintenance .............................................................................................................. 3 - 5

Accessories ....................................................................................................................... 4 - 1

Standard Kits.................................................................................................................................................. 4 - 1

Optional Accessories ...................................................................................................................................... 4 - 2

NIBP Accessories..................................................................................................................................... 4 - 2

Accessories.................................................................................................................................... 4 - 3

SpO

Miscellaneous Accessories........................................................................................................................ 4 - 3

Appendix ......................................................................................................................... 5 - 1

Specifications................................................................................................................................................. 5 - 1

Safety Standards ..................................................................................................................................... 5 - 1

Safety Designations ................................................................................................................................. 5 - 2

Hazard Analysis (Risk Management).......................................................................................................... 5 - 2

Performance/Accuracy ............................................................................................................................ 5 - 2

United States Food and Drug Administration Documents............................................................................... 5 - 3

Patient Parameter Specifications ....................................................................................................................... 5 - 4

NIBP Sub-System Performance Characteristics ............................................................................................. 5 - 4

Duo™ Operating Instructions 0070-10-0603-01 i

Tabl e o f Co nt ent s

Systolic Pressure Measurement .................................................................................................................. 5 - 4

Diastolic Pressure Measurement................................................................................................................. 5 - 4

Static Pressure Measurement ..................................................................................................................... 5 - 4

Pulse Rate from NIBP................................................................................................................................ 5 - 5

NIBP Sub-System Functional Requirements .................................................................................................. 5 - 5

Performance Requirements............................................................................................................... 5 - 6

SpO

Power Supply.......................................................................................................................................... 5 - 10

AC Mains Power Source .......................................................................................................................... 5 - 10

Battery Power.......................................................................................................................................... 5 - 10

Physical Characteristics ............................................................................................................................ 5 - 11

Cooling Fan............................................................................................................................................ 5 - 11

Environmental and Safety Characteristics.................................................................................................... 5 - 11

Warranty Statements....................................................................................................................................... 5 - 17

Manufacturer’s Responsibility ........................................................................................................................... 5 - 19

ii 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 this 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 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.

Duo™ Operating Instructions 0070-10-0603-01 iii

Introduction Warni ngs

Warnings

WAR N I NG: Th e Duo mon i tor is n o t inten d e d for u nsupervi s ed,

continuous monitoring. It is for spot-check use only.

WAR N I NG: Ma i n tain ex t reme ca u t ion whe n a defi b r illator i s in use ,

avoiding contact with any part of the patient, table or monitor.

WAR N I NG: Ro u t e cable s neatly. Ensure cables, hoses, and wires are

WAR N I NG: Th i s monito r is not i ntended for use i n an MR enviro n ment.

WARNING: The Duo monitor is intended for hospital use under the direct

WAR N I NG: Do not c l ean t h e moni t or wh i l e it is ON and/or connec t e d to

WAR N I NG: Th e Duo sh o u ld not b e used adjacent to or stacked with

WAR N I NG: Op e r ation o f the Du o below the minimum amplitude or

WAR N I NG: Us e of acces s o ries, transdu c ers, and cables other than those

WAR N I NG: Do n o t use a d amaged o r broken unit or accessory.

away from patient’s neck to avoid strangulation. Keep floors and walkways free of cables to reduce the risk of tripping.

supervision of a licensed health care practitioner.

AC power.

other equipment. If adjacent or stacked use is necess ary, the Duo should be observed to verify normal operation in the configuration in which it will be used.

value of patient physiological signal may cause inaccurate results.

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.

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.

iv 0070-10-0603-01 Duo™ Operating Instructions

Precautions Introduction

Precautions

CAUTION: Do not place the SpO2 sensor on an extremity with an

invasive catheter or blood pressure cuff in place.

CAUTION: The use of portable and mobile RF communications

equipment, in the proximity of the Duo, can affect the performance of this monitor.

CAUTION: Use only Mindray DS accessories with this product. For a

CAUTION: The patient size selection should be matched to the actual

CAUTION: Tissue damage or inaccurate measurement may be caused

CAUTION: Excessive ambient light may cause inaccurate SpO2

CAUTION: The cuff must be properly applied to the patient's limb

CAUTION: This product contains natural rubber latex which may cause

CAUTION: If the device is accidently saturated with any liquid,

comprehensive listing of Duo Accessories refer to section

4.0, “Accessories.”

patient before monitoring begins.

by incorrect SpO wrapping too tightly, applying supplemental tape, failing to inspect the sensor site periodically or failing to position appropriately. Carefully read the SpO and all precautionary information before use.

measurements. In such cases, cover the sensor site with opaque material.

before inflating. If it is inflated without being securely wrapped, damage to the cuff can result.

allergic reactions. This refers specifically to the large adult gray blood pressure cuff (0998-00-0003-35).

immediately discontinue use and contact service personnel.

sensor application or use, such as

sensor directions

Duo™ Operating Instructions 0070-10-0603-01 v

Introduction Precautions

CAUTION: Inaccurate SpO

measurements may be caused by:

•incorrect sensor application or use

•significant levels of dysfunctional hemoglobins, (e.g., carboxyhemoglobin or methemoglobin)

•intra-vascular dyes such as indocyanine green or methylene blue

•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.

•excessive patient movement

•venous pulsations

•electro-surgical interference

•placement of a sensor on an extremity that has a blood pressure cuff, arterial catheter or intra-vascular line.

•nail polish or fungus

CAUTION: In certain situations in which perfusion and signal strength

are low, such as in patients with thick or pigmented skin, inaccurately low SpO oxygenation should be made, especially in patients with

readings will result. Verification of

chronic lung disease, before instituting any therapy or intervention.

CAUTION: 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.

CAUTION: If the SpO

way, discontinue use immediately. To prevent damage, do

sensor or patient cable are damaged in any

not soak or immerse the sensor in any liquid solution. Do not attempt to sterilize.

CAUTION: When applying the SpO

proper positioning, alignment and skin integrity. Exercise

sensor to the patient, ensure

extreme caution with poorly perfused patients.

CAUTION: When equipped with Masimo SpO2, use only Masimo

oxygen sensors and cables. Use of other oxygen sensors may cause improper oximeter performance.

CAUTION: When equipped with Nellcor SpO

, use only Nellcor oxygen

sensors and cables. Use of other oxygen sensors may cause improper oximeter performance.

CAUTION: Use only Mindray DS blood pressure cuffs and hoses with

the Duo.

vi 0070-10-0603-01 Duo™ Operating Instructions

Precautions Introduction

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.

CAUTION: When cleaning SpO

amount of liquid. Wipe the sensor surface with a soft cloth,

sensors, do not use an excessive

dampened with a cleaning solution.

CAUTION: Do not subject the SpO

CAUTION: Do not use SpO

have deteriorated.

sensors or cables that are damaged or

sensor to autoclaving.

CAUTION: Some disinfectants may cause skin irritation. Please rinse

the NIBP cuffs thoroughly with water to remove any residual disinfectants.

CAUTION: Using dark colored soaps may stain the NIBP cuffs. Test a

single cuff to ensure that no damage will occur.

CAUTION: Disposable NIBP cuffs can be cleaned using a mild soap

solution and dried with a clean cloth.

CAUTION: Replace the Lithium Ion battery with part number 0146-00-

0079 only.

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.

CAUTION: To avoid permanent damage, do not expose metal

components (e.g., pins and sockets) to disinfectants, soaps or chemicals.

CAUTION: Only connect NIBP Luer fittings to Blood Pressure Cuff or

Monitor.

Duo™ Operating Instructions 0070-10-0603-01 vii

Introduction 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

NOTE: The comparison testing conducted via the auscultatory

NOTE: The use of this equipment is restricted to one patient at a

explanations are provided to assist in the identification and correction of problems that may occur with the monitor.

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.

time.

Indication for Use

The Duo monitor is intended for use in health 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.

viii 0070-10-0603-01 Duo™ Operating Instructions

Symbols Introduction

Symbols

SYMBOL DESCRIPTION SYMBOL DESCRIPTION

Attention, Consult Accompanying Documents / Refer to Manual

Type BF Equipment

Dangerous Voltage

Equipotentiality Battery Charging

Alternating Current (AC) NIBP

ON/OFF (only for a part of the equipment)

Patient Size (Adult/Pediatric)

Non-ionizing electromagnetic radiation

Defibrillator Proof Type BF Equipment

Data Input/Output

Clear/Next Patient

Consult Operating Instructions

A symbol designating compliance of the Duo monitor with the Medical Device Directive (MDD) 93/42/EEC.

Duo™ Operating Instructions 0070-10-0603-01 ix

Introduction Symbols

This page intentionally left blank.

x0070-10-0603-01Duo™ Operating Instructions

1.0

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 Ion 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 1 - 1

Controls and Indicators General Product Description

SpO

Source

Sys.

Dia

SpO

kPa

NIB

1.2 Controls and Indicators

1.2.1 Front Panel

The Duo front panel is the main user interface, providing the digital LED display, keypad, and connector panel.

FIGURE 1-1 Front Panel

1. Digital Display

The Duo digital display features parameter tiles, numeric LEDs and LED indicators.

1 - 2 0070-10-0603-01 Duo™ 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

•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.

•The labels for the unit of measure are mmHg or kPa.

b. Pulse Rate

•The Pulse Rate parameter tile is labeled with a heart symbol. The LEDs are red.

•The dual source labels are NIBP (red LED) and SpO

(green LED).

•The label for the unit of measure is bpm.

c. SpO2 (Optional)

•The SpO

parameter tile is labeled SpO2. The LEDs are green.

•The label for the unit of measure is %.

d. Information Codes

•Information and error codes are displayed in the window.

•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/SpO2.

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 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”.

1 - 4 0070-10-0603-01 Duo™ Operating Instructions

General Product Description Controls and Indicators

b c

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

•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.

•When the Duo is powered OFF, all parameter data is permanently deleted.

b. Clear/Next Patient

•While in normal monitoring mode, this key is used to delete all data (including an NIBP E13 one-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.

•When a measurement for NIBP is currently in progress, this key is not active.

c. Patient Size

• 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.

•When a measurement for NIBP is in progress, this key is not active.

d. NIBP Start/Stop

•This key is used to start an NIBP measurement and to stop an NIBP measurement that is already in progress.

Duo™ Operating Instructions 0070-10-0603-01 1 - 5

Controls and Indicators General Product Description

3. Connector Panel

FIGURE 1-5 Connector Panel

a. NIBP Pneumatic Fitting

• This Rectus*, Quick-Connect pneumatic fitting is used to attach the NIBP hose to the Duo.

b. SpO

Receptacle (optional)

•This receptacle is used to attach the SpO2 sensor to the Duo. The two versions of SpO2 technology that are available for use with the DUO are Masimo® and

Nellcor

*Quick Connect Pneumatic Fittings available from Rectus-TEMA Corporation.

1 - 6 0070-10-0603-01 Duo™ Operating Instructions

General Product Description Controls and Indicators

IEC 601-1:1988 CSA - C22.2 No. 601.1 - M90

UL 2601-1:1997

0044

V 100 - 240~ A 0.7 - 0.4

z 60 / 50

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.

FIGURE 1-6 Rear Panel

1. Serial Port

This is used to connect optional modules.

2. Equipotential Lug

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

Duo™ Operating Instructions 0070-10-0603-01 1 - 7

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.

Controls and Indicators General Product Description

1.2.3 Bottom Panel

The battery compartment and the mounting 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

•The mounting nut secures the Duo to the optional rolling stand.

b. Battery Compartment

•The battery compartment houses one user-replaceable, rechargeable Lithium Ion battery. For ease of use, the door for the battery compartment is tethered to the bottom panel and features a molded finger grip.

1 - 8 0070-10-0603-01 Duo™ Operating Instructions

2.0

Operation

2.1 Modes of Operation

The Duo functions in the following four (4) operating modes:

•Normal Monitoring Mode

•Standby Mode

•Auto Shutoff Mode

•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 Mode 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:

•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 2 - 1

Modes of Operation 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 specific events as follows:

EVENT

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 SpO

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.

2.1.3 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 the previous subsection for the conditions under which the Duo can enter Standby Mode.

2.1.4 Maintenance Mode

Maintenance Mode is a general reference to the following group of non-monitoring modes:

TIME PERIOD TO ENTER STANDBY MODE

data 3 minutes

•Unit of Measure Mode

•Version Mode

• NIBP Calibration Mode

•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.

2 - 2 0070-10-0603-01 Duo™ Operating Instructions

Operation Initial Set-Up

Battery Locking

Mechanism

Battery

Compartment

Door

Contacts

2.2 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:

•Remove the battery compartment door (shown in FIGURE2-1).

FIGURE 2-1 Battery Compartment

•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 Ion battery with its contacts (shown in FIGURE 2-2) facing the rear of the compartment.

FIGURE 2-2 Lithium Ion Battery

•Ensure that the locking mechanism engages over the end of the battery by pressing the

battery firmly into the compartment.

• Replace the battery compartment door.

Duo™ Operating Instructions 0070-10-0603-01 2 - 3

Initial Set-Up Operation

NOTE: The Lithium Ion battery is shipped in a partially charged

state and must be fully charged prior to its first use.

3. Charge the Lithium Ion battery as follows:

• Connect the AC power cord to the AC receptacle located on the rear panel.

•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.

•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:

•AC Power indicator (if AC power is present)

•Battery Charging indicator (if the battery is installed and AC power is present)

•Patient Size indicator (the current setting)

•Unit of Measure indicators (the most recent settings) for NIBP, Pulse Rate and SpO2

(optional)

If any portion of the internal diagnostics test fails, error codes are displayed in specific parameter tiles as described in "Information Codes and Error Codes" on page 2-13.

2.2.1 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 SpO2 (%) are not adjustable.

• The NIBP units of measure are mmHg and kPa.

The default setting is mmHg.

2 - 4 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 m ay th en tu rn th e Duo back on to resume normal operation.

NOTE: The Duo cannot be placed directly back into normal

monitoring mode after setting the units of measure. It must first be powered OFF.

Duo™ Operating Instructions 0070-10-0603-01 2 - 5

Routine Operation Operation

2.3 Routine Operation

This section provides guidelines and step-by-step instructions for the vital sign measurements that are routinely performed with the Duo.

2.3.1 NIBP Measurement

CAUTION: A patient's skin is sometimes fragile (i.e., on pediatric and

CAUTION: Please consult a physician for interpretation of blood

CAUTION: A blood pressure measurement can be affected by the

CAUTION: Any condition that may affect the regularity and strength of

pressure measurements.

position of the patient, and his/her physiological condition as well as other factors, such as patient movement.

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 (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 SETTING

Adult 178 ± 5 mmHg

Pediatric 133 ± 5 mmHg

DEFAULT CUFF INFLATION PRESSURE

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.

2 - 6 0070-10-0603-01 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 displayed. 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 to the cuff can result.

FIGURE 2-3 Application of the Blood Pressure Cuff

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 0070-10-0603-01 2 - 7

Routine Operation 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 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:

•15 minutes elapse since the last NIBP measurement

•The Clear/Next Patient key is pressed to clear the results

•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.

NOTE: Pressing the NIBP Start/Stop key while the NIBP

measurement is in progress will stop the measurement and deflate the cuff.

2.3.2 Pulse Rate Measurement

The Pulse Rate is determined from one of two sources: SpO2 and NIBP.

NOTE: If the optional SpO2 is no t pu rchased with the Duo , the Pulse

Rate source will be NIBP by default.

SpO2 is the higher priority source. If both SpO2 and NIBP are being actively monitored, SpO2 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.

•When determined from SpO2, the Pulse Rate updates approximately once every second. When SpO

•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,

The Pulse Rate results will display for the same maximum time that the source parameter (SpO

or NIBP) is displayed.

is no longer being monitored, the Pulse Rate parameter tile will be blank.

one-time measurement.

2 - 8 0070-10-0603-01 Duo™ Operating Instructions

Operation Routine Operation

2.3.3 SpO2 Measurement (Optional)

Each of the following terms are associated with blood oxygenation: oxygen saturation, pulse oximetry, SpO2 and plethysmography.

Oxygen saturation in capillary blood is measured by a method called pulse oximetry. Pulse oximetry is a continuous and non-invasive measurement of the amount of oxygen attached to the hemoglobin in red blood cells (also known as oxyhemoglobin saturation). SpO estimation of arterial oxygen saturation. This term is used interchangeably with SaO2. This value is displayed in the SpO

parameter tile.

is the

Traditional pulse oximetry determines SpO bed and measuring changes in light absorption during the pulsatile cycle. Red and infrared light-emitting 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.

by passing red and infrared light into a capillary

Performance Considerations

To e ns ur e op ti ma l Sp O2 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 include 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:

•If the patient is poorly perfused, try applying the sensor to another site - such as a different finger or toe.

•Ensure that the sensor is properly aligned and securely applied.

•Use a new sensor.

•Move the sensor to a less active site.

•Use a type of sensor that tolerates some patient motion.

•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 0070-10-0603-01 2 - 9

Routine Operation Operation

CAUTION: Do not place the SpO2 sensor on an extremity with an

CAUTION: Tissue damage or inaccurate measurement may be caused

CAUTION: Inaccurate SpO2 measurements may be caused by:

invasive catheter or blood pressure cuff in place.

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.

•incorrect sensor application or use

•significant levels of dysfunctional hemoglobins, (e.g., carboxyhemoglobin or methemoglobin)

•intra-vascular dyes such as indocyanine green or methylene blue

•excessive patient movement

•venous pulsations

•electro-surgical interference

•placement of a sensor on an extremity that has a blood pressure cuff, arterial catheter or intra-vascular line.

•nail polish or fungus

CAUTION: 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.

CAUTION: Many patients suffer from poor peripheral perfusion due to

CAUTION: If the SpO2 sensor or patient cable are damaged in any

CAUTION: When applying the SpO2 sensor to the patient, ensure

CAUTION: Excessive ambient light may cause inaccurate SpO2

hypothermia, hypovolemia, severe vasoconstriction, reduced cardiac output, etc. These symptoms may cause a loss in vital sign readings.

way, discontinue use immediately. To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilize.

proper positioning, alignment and skin integrity. Exercise extreme caution with poorly perfused patients.

measurements. In such cases, cover the sensor site with opaque material.

2 - 10 0070-10-0603-01 Duo™ Operating Instructions

Operation Routine Operation

2.3.3.1 Masimo SET® SpO

The Masimo pulse oximeter determines SpO2 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:

•Indicated for continuous non-invasive monitoring of arterial oxygen saturation (SpO and Pulse Rate

•Non-sterile

•Usable during patient movement

The LNOP 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

DCI Adult Reusable Finger Sensor is used for “spot check” applications if

oxygen sensors and cables. Use of other oxygen sensors may cause improper oximeter performance.

)

NOTE: Refer to instructions included with each SpO

cable for proper placement and use.

sensor and

1. Select an SpO2 sensor that is appropriate for the size of the patient.

2. Attach the SpO2 sensor to the patient’s finger.

3. Orient the connector so that the Masimo SET logo is

facing upward. Plug the connector into the SpO2 receptacle on the front panel of the Duo. The SpO2 measurement will display when the Duo detects that the sensor is connected to the patient.

These results are updated once every second and can display for a maximum of 2 minutes during continuous SpO

NOTE: To disconnect the cable from the Duo, squeeze the tabs on

the sides of the connector and then pull it straight out.

measurement.

Duo™ Operating Instructions 0070-10-0603-01 2 - 11

Routine Operation Operation

2.3.3.2 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

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.

NOTE: Refer to instructions included with each SpO2 sensor and

1. Select an SpO2 sensor that is appropriate for the size of the patient.

2. Attach the SpO2 sensor to the patient’s finger.

3. Attach the connector end of the SpO

the SpO

4. Plug the connector from the SpO

into the SpO Duo. The SpO2 measurement will display when the Duo detects that the sensor is connected to the patient.

These results are updated once every second and can display for a maximum of 2 minutes during continuous SpO2 measurement.

sensors and cables. Use of other oxygen sensors may cause improper oximeter performance.

cable for proper placement and use.

extension cable.

sensor to

extension cable

receptacle on the front panel of the

NOTE: To disconnect the cable from the Duo, squeeze the tabs on

the sides of the connector and then pull it straight out.

2 - 12 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.

•Codes that refer to the operational status of the monitor are preceded by a capital letter “E”.

•Codes that indicate that the device is in Maintenance Mode are numeric only.

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 Operation

2.4.1 Information Codes

MESSAGE TYPE CODE DESCRIPTION REASON

NIBP E03 *LOOSE CUFF Cuff is not properly wrapped or no cuff is

E06 SUCCESSFUL

PNEUMATIC TEST

E07 PNEUMATIC TEST

FAIL /PNEUM ATIC LEAK

E08 *WEAK SIGNAL Cuff is too loose or patient pulse is too

E09 *RANGE EXCEEDED NIBP value exceeds the upper

E10 EXCESSIVE MOTION

SIGNAL SATURATED

E11 *OVER PRESSURE Pressure has exceeded the specified upper

E13 *NIBP TIME OUT Measuring time has exceeded 120

MASIMO SPO2 E20 SPO2 INTERFERENCE Noise detected on the pulse signal

E21 SPO2 LOW

PERFUSION

E22 SPO2 TOO

MUCH LIGHT

E23 SPO2

UNRECOGNIZED SENSOR

E28 *SPO2 TIMEOUT SpO2 has exceeded its maximum

E29 SPO2 LOW SIGNAL IQQuality of signal is poor.

present.

Indicates NIBP pneumatic test was successful.

During pneumatic test, leak is detected.

weak.

measurement limit.

Monitor is detecting too much motion and/or noise to obtain a reading.

safety limit.

seconds (adult/pediatric).

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.

continuous measuring period of 2 minutes. The SpO2 data has been removed from the display.

E34 *PR EXCEED PR value exceeds the measurement range.

2 - 14 0070-10-0603-01 Duo™ Operating Instructions

Operation Information Codes and Error Codes

MESSAGE TYPE CODE DESCRIPTION REASON

NELLCOR SPO2 E40 SPO2 INTERFERENCE Noise is detected on the pulse signal

E41 SPO2 CHECK

SENSOR

E43 SPO2 WEAK PULSE A pulse rate can not be determined and

E44 SPO2 WEAK SIGNAL Noise is detected but a pulse rate can not

E46 SPO2 MOTION Motion is detected. The message is

E47 *SPO2 TIMEOUT SpO2 has been determined continuously

E34 PR EXCEED PR value exceeds the measurement range.

GENERAL/ TECHNICAL

E501 BAT. VOLTAGE LOW Battery voltage is low.

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 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.

all other measurement conditions are normal. The message is removed when a pulse is detected.

be discriminated. The message is removed when a pulse is detected.

removed when No Pulse status is detected or when motion ceases.

for more than 2 minutes, so SpO2 data has timed out from the display.

Duo™ Operating Instructions 0070-10-0603-01 2 - 15

Information Codes and Error Codes Operation

2.4.2 Error Codes

MESSAGE TYPE CODE DESCRIPTION REASON

NIBP E01 NIBP SELF TEST ERR NIBP module hardware failure.

E02 NIBP COMM ERR Communication with NIBP module has

failed.

E04 AIR LEAK Cuff, hose or connector is damaged.

Internal leak.

E05 AIR PRESSURE FAILURE Stable pressure value is not available.

(e.g., hoses are pinched or occluded)

E12 NIBP SYSTEM FAILURE Operation of blood pressure pump system

failed.

E14 *NIBP ILLEGALLY

RESET

E15 NIBP RESET FAILED NIBP reset failed.

E16 *NIBP COMM CRC

ERROR

E17 NIBP PATIENT SIZE

CHANGE ERR

MASIMO SPO2 E24 SPO2 COMM ERROR The monitor and the SpO2 modules are

E25 SPO2 BOARD FAULT Masimo SET board failed to operate

E26 SPO2 SENSOR FAULT Defective sensor.

NELLCOR SPO2 E42 SPO2 COMM ERROR The front end module is having problems

E45 SPO2 BOARD FAULT The SpO2 board malfunctions.

GENERAL/ TECHNICAL

E504 KEYBOARD ERR1 Error with front panel keypad board.

E505 MONITOR SHUTOFF

FAI LURE

E506 SPO2 MODULE NOT

RECOGNIZED

Unexpected NIBP reset.

NIBP Serial Communication failure

Attempt to change patient size failed

not communicating properly.

properly.

communicating (i.e., framing errors or bad checksums) with the Nellcor board.

Monitor cannot be turned off normally

Monitor cannot communicate with the SpO2 module during self-test.

2 - 16 0070-10-0603-01 Duo™ Operating Instructions

3.0

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 required by local statutory or hospital administration practice.

General Maintenance

Before using the Duo, perform the following general maintenance checks:

1. Perform a 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 fu n c t ions 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 3 - 1

Care and Cleaning of the Monitor User Maintenance

3.2 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.

WAR N I NG: Do not c l ean t h e moni t or wh i l e it is ON and/or connec t e d to

AC power.

To p re ve nt s cr at ch es o n the screen, carefully remove dust and dirt particles with a fine, softhair 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.

3.3 Care and Cleaning of Accessories

3.3.1 SpO2 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:

•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.

•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.

•Allow the sensor to completely dry before using.

CAUTION: When cleaning SpO2 sensors, do not use an excessive

CAUTION: Do not subject the SpO2 sensor to autoclaving.

CAUTION: If the SpO2 sensor or patient cable are damaged in any

CAUTION: Do not use SpO2 sensors or cables that are damaged or

amount of liquid. Wipe the sensor surface with a soft cloth, dampened with a cleaning solution.

way, discontinue use immediately. To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilize.

have deteriorated.

3 - 2 0070-10-0603-01 Duo™ Operating Instructions

User Maintenance Care and Cleaning of Accessories

3.3.2 Care and Cleaning of Reusable Cuffs

NOTE: Accuracy of cuff-pressure transducers/indicators is to be

verified at intervals specified by the manufacturer.

3.3.2.1 Reusable Cuffs with Bladders

Take o ut t he b la dd er b ef or e cl ea ni ng a nd d is in fe ctin g th e cu ff .

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. It 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:

1. Place the bladder on the top of the cuff, as the figure shows.

2. Roll the bladder lengthwise and insert it into the large opening. See the figures below.

3. Hold the hose and the cuff and shake the complete cuff until the bladder is in position.

4. 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 disinfectant other than fresh water or 70% isopropanol. Clean and disinfect the cuff according to the instructions.

Duo™ Operating Instructions 0070-10-0603-01 3 - 3

Care and Cleaning of Accessories User Maintenance

3.3.2.2 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.

3.3.2.3 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.

3 - 4 0070-10-0603-01 Duo™ Operating Instructions

User Maintenance Battery Replacement and Maintenance

Battery Locking

Mechanism

Battery

Compartment

Door

Contacts

3.4 Battery Replacement and Maintenance

Battery Replacement

CAUTION: Replace the Lithium Ion 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.

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 Ion battery with its contacts (shown in 3-2) facing the rear of the compartment.

FIGURE 3-2 Lithium Ion Battery

Duo™ Operating Instructions 0070-10-0603-01 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

CAUTION: Remove the battery prior to shipping the Duo.

extended period of time.

The Duo monitor uses a Lithium Ion 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

4.0

Accessories

4.1 Standard Kits

Masimo SET® Adult/Ped Single-Patient Adhesive 0020-00-0123-01

DESCRIPTION PART NUMBERS

(2) LNOP

(1) Patient Cable, 12’ (3.7 m) 0012-00-1099-02

Adt Adult Single-Patient Adhesive Finger Sensor 0600-00-0043-02

Pdt Pediatric Single-Patient Adhesive Finger Sensor 0600-00-0044-02

Duo™ Operating Instructions 0070-10-0603-01 4 - 1

Optional Accessories Accessories

4.2 Optional Accessories

4.2.1 NIBP Accessories

Hoses

DESCRIPTION PART NUMBERS

NIBP Hose, 5’ (1.5 m), Female Rectus/Female Rectus (for use with Reusable Cuffs and Adult/Child Disposable Cuffs)

NIBP Hose, 10’ (3.5 m), Female Rectus/Female Rectus (for use with Reusable Cuffs and Adult/Child Disposable Cuffs)

Reusable Cuffs - Quick-Connect

DESCRIPTION PART NUMBERS

Reusable NIBP cuff, Child, 10 to 19cm, quick connect 0683-15-0001-01

Reusable NIBP cuff, Small Adult, 18 to 26cm, quick connect 0683-15-0002-01

Reusable NIBP cuff, Adult, 25 to 35 cm, quick connect 0683-15-0003-01

Reusable NIBP cuff, Large Adult, 33 to 47cm, quick connect 0683-15-0004-01

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

Reusable NIBP Cuff, Large Adult Long, 33 - 47 cm, quick connect 0683-15-0007-01

0683-04-0003

0683-04-0004

Disposable Cuffs - Quick-Connect

DESCRIPTION PART NUMBERS

Disposable NIBP cuff, Child, 10 to 19cm, quick connect, box of 10

Disposable NIBP cuff, Small Adult, 18 to 26cm, quick connect, box of 10

Disposable NIBP cuff, Adult, 25 to 35 cm, quick connect, box of 10

Disposable NIBP cuff, Large Adult, 33 to 47cm, quick connect, box of 10

Disposable NIBP cuff, Thigh, 46 to 66cm, quick connect, box of 5

Disposable NIBP Cuff, Adult Long, 25 – 35 cm, quick connect, box of 10

Disposable NIBP Cuff, Large Adult Long, 33 - 47 cm, quick connect, box of 10

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

4 - 2 0070-10-0603-01 Duo™ Operating Instructions

Accessories Optional Accessories

4.2.2 SpO2 Accessories

Masimo SET

DESCRIPTION PATIENT SIZE PART NUMBERS

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

Sensors

> 30 kg 0600-00-0043-01

10 to 50 kg 0600-00-0044-01

> 30 kg 0600-00-0047

Masimo SET® Cables and Accessories

DESCRIPTION PART NUMBER

SpO2 cable, PC08, 8’ (2.4 m) 0012-00-1099-01

cable, PC12, 12’ (3.7 m) 0012-00-1099-02

SpO

Clothing Clips (pkg of 5) 0600-00-0084

Nellcor® OxiMax® Cables and Accessories*

DESCRIPTION PART NUMBER

Durasensor DS100A Adult Reusable Sensor 0600-00-0051

DOC-10 OxiMax

* Sensors must be reordered through Nellcor.

SpO2 Cable 0012-00-1464

4.2.3 Miscellaneous Accessories

DESCRIPTIONS PART NUMBER

Battery, Lithium Ion 0146-00-0079

AC Power Cord, (110 Volt) 0012-25-0001

AC Power Cord, (220 Volt) 0012-25-0002

AC Power Cord, UK, (240 Volt) 0012-25-0003

Duo Rolling Stand Kit DUOROLLSTD

Duo Mounting Bracket for rolling stand 0406-00-0857-01

Duo™ Operating Instructions 0070-10-0603-01 4 - 3

Optional Accessories Accessories

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4 - 4 0070-10-0603-01 Duo™ Operating Instructions

5.0

Appendix

5.1 Specifications

The Duo monitor complies with the following standards:

5.1.1 Safety Standards

IEC 60601-1:1988 (+ A1:1991, A2:1995)/ EN 60601-1:1990 (+ A1:1993, A2:1995, A13:1995)

UL 60601-1:2003 Medical Electrical Equipment - Part 1

CSA Standard C22.2 No. 601.1M90

IEC 60601-1-2:2001/ EN 60601-1-2:2001

IEC 60601-1-4:1996/ EN60601-1-4:1996 (+A1:1999)

IEC 60601-2-49:2001 Particular Requirements for the Safety of Multifunction

Medical Electrical Equipment Part 1: General Requirements For Safety

General Requirements for Safety

Medical electrical Equipment General Requirements for Safety

Medical Electrical Equipment Part 1-2: General Requirements for Safety: EMC Requirements and Tests

Collateral Standard: Programmable Electrical Medical Systems

Patient Monitoring Equipment

Duo™ Operating Instructions 0070-10-0603-01 5 - 1

Specifications Appendix

5.1.2 Safety Designations

Type of protection against electric shock

Degree of protection against electric shock:

Supply Connection: 100 – 240 VAC (+/-10%)

Mode of Operation: Continuous

Protection Against Hazards of Explosion:

Protection Against Ingress of Liquid's:

Degree of electrical connection between equipment and patient:

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

50/60 Hz (+/-3 Hz)

0.7 – 0.4 Amps

7.2 VDC Internal Battery

Not protected (Ordinary)

Not protected (Ordinary) - IPX0 per IEC 60529

Equipment designed for non-electrical connection to the patient

Degree of Mobility: Transportable

5.1.3 Hazard Analysis (Risk Management)

EN ISO14971:2000 Medical Devices-Application of risk management

analysis to medical devices

5.1.4 Performance/Accuracy

EN 865:1997 Pulse Oximeters - Particular Requirements

EN 1060-1:1995 Specification for Non-invasive Sphygmomanometers

EN 1060-3:1997 Non-invasive Sphygmomanometers, Supplementary

Requirements for Electromechanical Blood Pressure Measuring Systems

5 - 2 0070-10-0603-01 Duo™ Operating Instructions

Appendix Specifications

ISO 3744:1994 Acoustics - Determination of Sound Power Levels of

Noise Sources Using Sound Pressure

ANSI/AAMI/ISO 1099310:1995

ANSI/AAMI/ISO 10993-5 Biological evaluation of medical devices-Part 5:

ANSI/AAMI/ISO 10993-1:1997 Biological evaluation of medical devices-Part 1:

ANSI/AAMI SP-10:1992 Electronic or Automated Sphygmomanometers

EN 1041:1998 Information Supplied by the Manufacturer with

EN 980:1996 + A1:1999 + A2:2001

IEC 878:1998 Graphical Symbols for Electrical Equipment in

ISO 1000:1992 + A1:1998 SI units and recommendations for the use of their

Biological evaluation of medical devices-Part 10: Tests for ir rit ati on a nd sen siti zat ion

Cytotoxicity

Evaluation and testing

Medical Systems

Graphical Symbols for Use in Labeling of Medical Devices

Medical Practice

multiples and of certain other units

5.1.5 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 Patient Parameter Specifications

5.2.1 NIBP Sub-System Performance Characteristics

The NIBP function is capable of providing 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.

5.2.2 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

5.2.3 Diastolic Pressure Measurement

Accuracy*: Mean error is less than ±5 mmHg, Standard

deviation is less than ±8 mmHg

Range:

* 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

ADULT MODE PEDIATRIC MODE

10 to 210 mmHg 10 to 150 mmHg

5.2.4 Static Pressure Measurement

Range: 0 – 325 mmHg

Static Accuracy: ±3 mmHg over the entire range.

5 - 4 0070-10-0603-01 Duo™ Operating Instructions

Appendix Patient Parameter Specifications

5.2.5 Pulse Rate from NIBP

Accuracy: ± 1 bpm

Resolution: 1 bpm

Range:

ADULT MODE PEDIATRIC MODE

40 to 240 bpm 40 to 240 bpm

5.2.6 NIBP Sub-System Functional Requirements

5.2.6.1 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

5.2.6.2 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.

5.2.6.3 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.

5.2.6.4 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.

5.2.6.5 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 NIBP Start Pressure Settings and Ranges

The Start Pressure is adjustable and is set to the following defaults:

PATIENT SIZE

Adult Mode 30 – 60 mmHg 178 ±5 mmHg

Pediatric Mode 30 – 60 mmHg 133 ±5 mmHg

PRESSURE INCREMENT (DEPENDING ON ALGORITHM) DEFAULT START PRESSURE

5.2.6.7 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.

5.2.7 SpO2 Performance Requirements

The Duo monitor is capable of providing SpO2 functional saturation level measurements via an OEM Masimo MS-7 pulse oximeter, or an OEM Nellcor MP-506 pulse oximeter.

5.2.7.1 SpO2 Agency Requirements

The SpO2 function performs in accordance with the requirements of EN 865: 1997.

5.2.7.2 Masimo SpO2 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%

5 - 6 0070-10-0603-01 Duo™ Operating Instructions

Appendix Patient Parameter Specifications

Accuracy:

No motion conditions

During motion conditions

PATIENT SIZE SATURATION RANGE

70% to 100% 0 – 69%

Adult Mode ±2 digits unspecified

Pediatric Mode ±2 digits unspecified

PATIENT SIZE SATURATION RANGE

70% to 100% 0 – 69%

Adult Mode ±3 digits unspecified

Pediatric Mode ±3 digits unspecified

Response Time: 20 seconds to 95% of final step change of % SpO2

value from 60 to 95% at 75 bpm. Post averaging time is set at 8 seconds.

Low Perfusion Performance

LOW PERFUSION CONDITIONS

PULSE AMPLITUDE

> 0.02% > 5% ±2 digits ±3 digits

% TRANSMISSION

SATURATION ACCURACY

PULSE RATE ACCURACY

Pulse Rate

Resolution: 1 bpm

Update Rate: 1 Hz.

Range and Accuracy

PATIENT SIZE

Adult/Pediatric 25 – 240 bpm ±3 digits ±5 digits

Duo™ Operating Instructions 0070-10-0603-01 5 - 7

PULSE RATE RANGE ACCURACY

NO MOTION

CONDITIONS

DURING MOTION

CONDITIONS

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 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 non-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 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 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.

against a laboratory co-oximeter and ECG

against a laboratory co-oximeter and

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

5.2.7.3 Nellcor SpO2 Performance Requirements

SpO

Sensor Compatibility: OxiMax series MAX-A, MAX-AL, MAX-P, MAX-FAST,

MAX-R, OxiCliq A, OxiCliq P, D- Y S, D- Y SE , D - Y SP D , DS-100A, OXI-A/N and OXI-P/I.

Display Range: 1 – 100%

Resolution: 1%

Saturation Accuracy:

SENSOR ACCURACY

MAX-A, MAX-AL, MAX-P, MAX-I and MAX-FAST

OxiCliq A, OxiCliq P and OxiCliq I 70% to 100% ±2.5 digits

D-YS, DS-100A, OXI-A/N and OXI-P/I

MAX-R, D-YSE and D-YSPD 70% to 100% ±3.5 digits

70% to 100% ±2 digits Below 70% unspecified

Below 70% unspecified

70% to 100% ±3 digits Below 70% unspecified

Below 70% unspecified

Pulse Rate

Resolution: 1 bpm

Update Rate: 1 Hz.

Range and Accuracy

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.

RANGE ACCURACY

20 to 250 bpm ±3 bpm

251 to 300 bpm Unspecified

Duo™ Operating Instructions 0070-10-0603-01 5 - 9

Patient Parameter Specifications Appendix

5.2.8 Power Supply

5.2.8.1 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.

5.2.9 AC Mains Power Source

Input Voltage: 100 – 240 VAC (+/-10%)

Line Frequency: 50/60 Hz (+/-3 Hz)

Current: 0.7 – 0.4 Amps

5.2.10 Battery Power

Time to Shutdown from Low Battery:

>10 minutes but < 20 minutes after indication, with 1 new, fully charged battery.

5.2.10.1 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 NIBP measurements taken at 7 minute intervals.

17.0 hours with NIBP only and measurements taken at 7 minute intervals.

17.5 hours with continuous SpO no NIBP measurements being taken.

The Battery Charge Time: 4.5 hours maximum.

measurement and

5 - 10 0070-10-0603-01 Duo™ Operating Instructions

Appendix Patient Parameter Specifications

5.2.11 Physical Characteristics

5.2.11.1 Maximum Size

130 mm maximum width

243 mm maximum height

140 mm maximum depth

5.2.11.2 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

5.2.12 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.

5.2.13 Environmental and Safety Characteristics

Storage Temperature: -20 ºC to +60 ºC

Operating Temperature: +5 ºC to +40 ºC

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.

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 Appendix

Sinusoidal Vibration: 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

Random Vibration: Per IEC 60068-2-34

0.02 g2/Hz 20 – 500 Hz Low degree of reproducibility 9 minutes per axis

Drop: The monitor meets the requirements specified by

ECRI PB-296 892 section AIII 3.3 for Class 3 devices.

Impact: The monitor meet the requirements specified by ECRI

PB-296892, section AIII 3.2 for Class 3 devices.

5 - 12 0070-10-0603-01 Duo™ Operating Instructions

Appendix Patient Parameter Specifications

Electromagnetic Compatibility

•The Duo meets the requirements of IEC 60601-1-2:2001/EN 60601-1-2:2001.

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 assure that it is used in such an environment.

EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Volt age fluctuations/ Flicker emissions IEC 61000-3-3

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

Complies

connected to the public low-voltage power supply network that supplies buildings used for domestic purposes

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 TEST

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Duo™ Operating Instructions 0070-10-0603-01 5 - 13

IEC 60601 TEST LEVEL

±6 kV contact ±8 kV air

±2 kV for power supply lines ±1 kV for input/ output lines

±1 kV differential mode ±2 kV common mode

COMPLIANCE LEVEL

±6 kV contact ±8 kV air

±2 kV for power supply lines ±1 kV for input/ output lines

±1 kV differential mode ±2 kV common mode

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

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.

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 TEST

Volt age d ips, short interruptions and

IEC 60601 TEST LEVEL

<5% U

(>95%

dip in U

0.5 cycle

) for

COMPLIANCE LEVEL

<5% U

(>95%

dip in U cycle

) for 0.5

voltage variations on power supply input lines IEC

40% UT (60% dip in U 5 cycles

) for

40% UT (60% dip in U 5 cycles

) for

61000-4-11

Power frequency

70% UT (30% dip in U 25 cycles

) for

<5% UT (>95% dip in U sec.

) for 5

3 A/m 3 A/m Power frequency magnetic fields

70% UT (30% dip in U 25 cycles

) for

<5% UT (>95% dip in U sec.

) for 5

(50/60 Hz) magnetic field IEC 61000-4-8

is the A.C. mains voltage prior to application of the test level.

ELECTROMAGNETIC ENVIRONMENT - GUIDANCE

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.

should be at levels characteristic of a typical location in a typical commercial or hospital environment.

5 - 14 0070-10-0603-01 Duo™ Operating Instructions

Appendix Patient Parameter Specifications

PPP

TABLE 5-3

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

IEC 60601 TEST LEVEL

3 Vrms 150 kHz to 80 MHz

3 V/m 80 MHz to 2.5 GHz

COMPLIANCE LEVEL

3 Vrms d = 1.2 x

3 V/m d = 1.2 x 80 MHz to 800 MHz

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 = 2.3 x 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

range.

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE: At 80 MHz and 800 MHz, 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.

aField 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 theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic 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 operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Duo.

bOver the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Duo™ Operating Instructions 0070-10-0603-01 5 - 15

Patient Parameter Specifications Appendix

PPP

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 interference 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 TRANSMITTER W (WATTS)

SEPARATION DISTANCE ACCORDING TO FREQUENCY

OF TRANSMITTER M (METERS)

150 kHz to 80 MHz

D = 1.2 x

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

11.21.22.3

10 3.8 3.8 7.3

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

NOTE: These guidelines may not apply in all situations.

NOTE: The Duo is intended for use in the electromagnetic

higher frequency range applies.

Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

environment specified below. The customer or the user of the Duo should assure that it is used in such an environment.

80 MHz to 800 MHz

D = 1.2 x

800 MHz to

2.5 GHz

D = 2.3 x

•The Duo meets the additional electromagnetic compatibility requirements of the FDA

Reviewer Guidance for Pre-market Notification Submission, November 1993 listed below:

AC Voltage Dropout: < 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 @ 7 cm

5 - 16 0070-10-0603-01 Duo™ Operating Instructions

Appendix War ran ty Sta tement s

5.3 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 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.

Damage to any product or parts through misuse, neglect, accident, or by affixing any nonstandard 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 0070-10-0603-01 5 - 17

War ranty Statem ent s 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:

a. assembly operations, extensions, readjustments, modifications or repairs are

performed by persons authorized by Mindray DS USA, Inc.; and

b. the electrical installation of the relevant room complies with the appropriate

requirements; and

c. the equipment is used in accordance with the instructions for use.

Duo™ Operating Instructions 0070-10-0603-01 5 - 19

0070-10-0603-01 Rev E May 24, 2010

Service Manual

Duo™ is a U.S. trademark of Mindray DS USA, Inc.

Navigator

™

Masimo SET

is a U.S. trademark of Mindray DS USA, Inc.

, LNOP® and CleanShield® are U.S. registered trademarks of Masimo Corp.

orm without permission of Mindray DS USA, Inc.

0070-10-0604-01 Duo Service Manual

Tabl e o f Co nt en ts

Foreword....................................................................................................................................................... iii

Warnings, Precautions And Notes ....................................................................................................................iii

Theory of Operation ......................................................................................................... 1 - 1

Introduction.................................................................................................................................................... 1 - 1

Hardware Overview ....................................................................................................................................... 1 - 2

Power Supply Board ................................................................................................................................ 1 - 2

Fan Driver Board Overview ...................................................................................................................... 1 - 4

CPU/Display Board Overview .................................................................................................................. 1 - 4

NIBP Module Overview............................................................................................................................ 1 - 5

Overview....................................................................................................................................... 1 - 6

SpO

Calibration and Performance Verification.......................................................................... 2 - 1

Introduction.................................................................................................................................................... 2 - 1

Warnings and Guidelines................................................................................................................................ 2 - 2

Test Equipment and Special Tools Required........................................................................................................ 2 - 2

Calibration and System Checks ........................................................................................................................ 2 - 3

Device Appearance and Installation Checks................................................................................................ 2 - 3

Maintenance Functions/Non-Monitoring Modes .......................................................................................... 2 - 3

Unit of Measure Mode ............................................................................................................................. 2 - 3

Software Version Mode............................................................................................................................ 2 - 4

Safety Test ..................................................................................................................................................... 2 - 5

Test Equipment ........................................................................................................................................ 2 - 5

Case Leakage ......................................................................................................................................... 2 - 5

NIBP Calibration............................................................................................................................................. 2 - 6

Test Equipment ........................................................................................................................................ 2 - 6

Test Procedure......................................................................................................................................... 2 - 6

Verification ........................................................................................................................................... 2 - 8

SpO

Test Equipment ........................................................................................................................................ 2 - 8

Test Procedure......................................................................................................................................... 2 - 8

Parts ................................................................................................................................ 3 - 1

Introduction.................................................................................................................................................... 3 - 1

Parts Listing .................................................................................................................................................... 3 - 10

Repair Information ........................................................................................................... 4 - 1

Introduction.................................................................................................................................................... 4 - 1

Troubleshooting Guide .................................................................................................................................... 4 - 2

Disassembly Instructions................................................................................................................................... 4 - 6

Tools Needed ......................................................................................................................................... 4 - 6

Front Housing Removal............................................................................................................................. 4 - 6

Interface Board Removal ................................................................................................................. 4 - 6

SpO

Board Removal............................................................................................................................... 4 - 6

SpO

CPU/Display Board Removal .................................................................................................................... 4 - 6

NIBP Module Removal ............................................................................................................................. 4 - 6

Power Supply Removal............................................................................................................................. 4 - 7

Duo™ Service Manual 0070-10-0604-01 i

Tabl e o f Co nt ent s

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ii 0070-10-0604-01 Duo™ Service Manual

Foreword 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, 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 NOTE is provided when additional general information is applicable.

Duo™ Service Manual 0070-10-0604-01 iii

Introduction War nin gs, Pre cau tio ns And No tes

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iv 0070-10-0604-01 Duo™ Service Manual

1.0

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 patients. The Duo monitor can be powered by either the internal rechargeable Lithium-Ion battery or external 100~240 volt 50/60 Hz AC.

(optional), and pulse rate on adult and pediatric

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Hardware Overview Theory of Operation

1.2 Hardware Overview

Patient Connectors

Fan Driver

AC Input

Power Supply

Lithium-Ion

Battery

FIGURE 1-1 Interconnection Block diagram

*The Isolated SpO2 Power Supply is present with optional Masimo and Nellcor SpO2 ONLY. ** The RS232 - TTL Inverter and Serial Interface Connector is used for software updates by Service

1.2.1 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-Ion 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.

External Interface

NIBP Module

Keypad Switches

CPU / Display pcb

RS232 - TTL Inverter**

Module

SpO

Isolated SpO Power Supply*

Serial Interface**

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.

Power ON / OFF Control Circuit

AC Input

AC / DC

Converter

Battery and Charging Management Circuit

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3.3v DC/DC Converter

12v DC/DC Converter

Theory of Operation Hardware Overview

FIGURE 1-2 Power Supply Block Diagram

Power Supply Voltage Test Points:

Location Function

Measure across C5 Primary Rectified Voltage (DC). Range: 105 - 374 volts.

C5 Negative Lead Primary Ground.

Measure across Q1 pin1 and C5 Negative Lead

Measure across C12 +10.5 vdc input for Fan Driver board.

C12 Negative Lead Secondary Ground.

C47 Positive Lead +5 vdc supply for Power On/Off Control.

C50 Positive Lead +3.3 vdc output.

C68 Positive Lead +12 vdc output.

110k Hz Drive frequency.

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Hardware Overview Theory of Operation

1.2.2 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 Input

FIGURE 1-3 Fan Driver Block Diagram

Fan Driver Circuit

Fan Driver Board Test Points

Location Function

Measure across C202 +5 vdc Fan power.

C202 Negative Lead Ground.

Measure between Q202 pin1 and Ground Drive frequency when the Fan is activated.

1.2.3 CPU/Display Board Overview

The CPU/Display board controls the SpO2 Module and NIBP Module through communications via UART devices. The CPU Board receives user commands 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 on JP1) and to drive the LED arrays and indicators.

Fan

module (SpO2 presence is detected via a jumper

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Theory of Operation Hardware Overview

A/D Converter

CPU

To External Interface

To SpO2 Module

Serial Interface

To NIBP Module

FPGA

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

RTC/ E2 PROM

User Interface

LED Array

Display

Keypad

Indicator

LEDs

ADV +10.5 vdc ADV out

RST CPU reset line

XT2 11.0592 MHz clock

1.2.4 NIBP Module Overview

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 deflate, 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.

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Hardware Overview Theory of Operation

1.2.5 SpO2 Overview

Pulse oximetry (SpO2) measurement is used to determine the oxygen saturation level of the patient's blood. The SpO2 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 SpO

value. The SpO2 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 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 SpO2 board.

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2.0

Calibration and Performance Verification

2.1 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.

Duo™ Service Manual 0070-10-0604-01 2 - 1

War nin gs and Guide lin es Ca lib rat ion and Performance Verification

2.2 Warnings and Guidelines

In the event that the instrument cover is removed, observe the following warnings and guidelines:

1. Do not short component leads together.

2. Perform all steps in the exact order they are given.

3. Use extreme care when reaching inside the opened instrument. Do not contact exposed

metal parts that may become ‘‘live’’.

4. Read through each step in the procedure so it is understood prior to performing the step.

2.3 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

•NIBP simulator

•Safety Analyzer (Dempsey model 431 or equivalent)

•Oscilloscope

•Laptop or PC (software upgrade)

simulator

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Calibration and Performance Verification Calibration and System Checks

2.4 Calibration and System Checks

2.4.1 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)

2.4.2 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.

2.4.3 Unit of Measure Mode

The unit of measure mode is used to change between mmHg and kPa. To access the Unit of Measure mode:

1. Turn the monitor off.

2. Simultaneously press and hold the POWER and CLEAR buttons.

3. Press the CLEAR button to cycle through the unit of measure choices.

4. Once the desired unit of measure is displayed, turn the Duo off to save that setting.

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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 r et ur n to n or ma l oper at io n, p re ss t he Power ON/OFF key for two (2) seconds to

turn the Duo off.

8. You m ay th en tu rn th e Duo back on to resume normal operation.

NOTE: The Duo cannot be placed directly back into normal

monitoring mode from Software Version Mode. It must first be powered OFF.

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Calibration and Performance Verification Safety Test

2.5 Safety Test

2.5.1 Test Equipment

•Safety Analyzer (Dempsey model 431 or equivalent)

2.5.2 Case Leakage

1. Plug 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 <100 uA under normal operating conditions; <300 uA

under single fault conditions for 120 VAC and <500 uA under single fault conditions for 230 VAC.

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NIBP Calibration Calibration and Performance Verification

2.6 NIBP Calibration

2.6.1 Test Equipment

•NIBP simulator

•NIBP test chamber/dummy cuff

•Manometer with bulb

2.6.2 Test Procedure

2.6.2.1 Transducer Accuracy

1. Connect the 500 cc Test Chamber and calibrated manometer via a ‘‘T’’ fitting to the

NIBP fitting on the Duo monitor under test.

2. 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.

3. Momentarily press the NIBP START/STOP button to start the NIBP calibration. Vent the

Test C ha mb er a nd v er if y th e Duo and the manometer read zero. Using the bulb, pressurize the test 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.

2.6.2.2 Pneumatic Leak Test

1. Connect the 500 cc test chamber to the NIBP fitting on the Duo monitor under test.

2. 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.

3. 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.

4. After approximately 20 seconds, the Duo under test will vent the pressure in the test

chamber and display a message code E06 (Pass) or E07 (Fail) in the systolic window.

2.6.2.3 Dynamic Repeatability Test

1. Restart unit and allow it to enter normal operating mode.

2. 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.

3. Select Adult patient size for both the Duo under test and the NIBP simulator.

4. Select a target simulated blood pressure within the ‘‘normal’’ range on the simulator.

5. Take 1 0 su cc es si ve N IB P re ad in gs a nd c om pare 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%, whichever is greater for heart rate.

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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.

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SpO2 Verification Calibration and Performance Verification

2.7 SpO2 Verification

2.7.1 Test Equipment

•SpO2 simulator

2.7.2 Test Procedure

1. Connect the appropriate SpO2 probe connector to the Duo monitor.

2. Connect the SpO

3. Set the simulator target values to:

= 98%

SpO

Pulse Rate = 70

4. Verify that the d isplayed SpO2 and pulse rate values on the Duo monitor are +/- 2% of

the simulator target values.

5. Change the simulator values.

Ver ify the d i s pl ayed values on the

probe to the SpO2 simulator.

Duo

monitor are equal to the simulator values +/- 2%.

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3.0

Parts

3.1 Introduction

This section contains exploded views of the Duo monitor, internal modules, and parts list.

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Introduction Parts

SpO2 Module

See SpO2 Detail

FIGURE 3-1 Duo Exploded View

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Parts Introduction

FIGURE 3-2 Masimo SpO2 Detail

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Introduction Parts

16a

FIGURE 3-3 Nellcor SpO2 Detail

17a

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Parts Introduction

Battery Latch Detail

FIGURE 3-4 Main Frame

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Introduction Parts

FIGURE 3-5 Rear Case Assembly

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Parts Introduction

FIGURE 3-6 Front Case Assembly

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Introduction Parts

FIGURE 3-7 Battery Connector Assembly Detail

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Parts Introduction

Screws, mounting plate*

Wash ers, locki ng*

Utility basket

Mounting screw for basket*

Casters, Non locking

Duo monitor mounting plate*

Mounting screw for basket*

Casters, lockin

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

Wash ers, lock ing*

Mounting bolts, pole*

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Parts Listing Parts

3.2 Parts Listing

REF. NUMBER PART NUMBER DESCRIPTION

10211-00-0146Housing Screw (metric panhead)

20380-00-0475Rear Housing

30441-00-0107Chassis

40671-00-0045Power Supply Board

50211-00-0145Metric Panhead Screw

60671-00-0044CPU/Display Board

70213-00-0032Self Tapping Screw

80380-00-0472Nellcor Connector Shroud

8A 0380-00-0473 Masimo Connector Shroud

90380-00-0476Front Housing

10 0012-00-1595 SpO

11 0671-00-0246 Masimo Isolated Power Board

12 0211-00-0143 Screw

13 0671-00-0243 Masimo SpO

14 0012-00-1474 Masimo Flex Cable

15 0671-00-0247 Nellcor Isolated Power Board

16 0671-00-0242 Nellcor SpO

16a 0671-00-0066 Nell-3 SpO

17 0012-00-1457 Nellcor Flex Cable

17a 0012-00-1661 Nellcor Flex Cable

18 0386-00-0308 SpO

19 0104-00-0037 NIBP Module

20 0671-00-0063 Fan Driver Board

21 0671-00-0043 Battery Connector Board

22 0380-00-0481 Battery Latch

23 0380-00-0474 Battery Door

24 0346-00-0052 Battery Door Tether

25 0012-00-1592 Fan with cable

26 0348-00-0216 Fan Gasket

27 0213-00-4014 Screw

28 0386-00-0310 Fan Mounting Plate

29 0380-00-0471 Filler Panel

30 0367-00-0084 Handle

31 0211-00-0147 Handle Screw (metric panhead)

32 0334-00-1603-03 Rear Label, Lower, S/N

33 0348-00-0202 Foot

34 0380-00-0480-01 Power Switch Plunger

35 0380-00-0480-02 Clear Switch Plunger

36 0380-00-0480-03 Patient Size Switch Plunger

37 0380-00-0480-04 Start NIBP Switch Plunger

N/S - Not Shown

Power Cable

Board

Mounting Plate

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Parts Parts Listing

REF. NUMBER PART NUMBER DESCRIPTION

38 0330-00-0052 Keypad Overlay

39 0103-00-0411 Pneumatic Fitting

40 0386-00-0309 Mounting Plate

41 See table below Rear Label, Upper

N/S See table below Display Overlay

N/S See table below Connector Label

N/S - Not Shown

Display Overlay

LANGUAGE OPTION PART NUMBER

English NIBP Only 0330-00-0053-01

English NIBP/SpO

0330-00-0053-11

Upper Rear Label

LANGUAGE PART NUMBER

English 0334-00-1641-01

Connector Label

DESCRIPTION PART NUMBER

No SpO

Masimo SpO

Nellcor SpO

0334-00-1602-01

0334-00-1602-02

0334-00-1602-04

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Parts Listing Parts

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4.0

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.

To P1 on Main Control Board

External Interface

Serial Interface

Battery P1

Fan

RS232<>TTL Inverter

Power Supply Board

Fan

P2 P1

Drive Board

FIGURE 4-1 Module Interconnection

Isolated Power

P1 P2

Board

Isolated Power

P1 P2

Board

Main

Control Board

Masimo SpO2

J3 J1

Module

Nellcor SpO2

J2 J1

Module

NIBP Module

SpO2 Sensor

Cuff

Duo™ Service Manual 0070-10-0604-01 4 - 1

Mindray Datascope Duo Service manual

Specifications and Main Features

Frequently Asked Questions

User Manual