Mindray Datascope Duo Service manual

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.

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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.

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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.

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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.

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