Duo Operation - Service Manual Rev F July 2010

Duo™ is a U.S. trademark of Mindray DS USA, Inc. Navigator™ is a U.S. trademark of Mindray DS USA, Inc. Masimo SET®, LNOP® and CleanShield® are U.S. registered trademarks of Masimo Corp. Nellcor® and OxiMax® are U.S. registered trademarks of Nellcor Puritan Bennett Inc.

Copyright © Mindray DS USA, Inc., 2008. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Mindray DS USA, Inc.

0070-10-0603-01

Duo™ Operating Instructions

Table of Contents

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 SpO2 Measurement (Optional)... 2 - 9 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 SpO2 Sensors ... 3 - 2 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 SpO2 Accessories... 4 - 3 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

Table of Contents

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 SpO2 Performance Requirements... 5 - 6 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

Warnings

Warnings WARNING: The Duo monitor is not intended for unsupervised, continuous monitoring. It is for spot-check use only. WARNING: Maintain extreme caution when a defibrillator is in use, avoiding contact with any part of the patient, table or monitor. WARNING: Route cables neatly. Ensure cables, hoses, and wires are away from patient’s neck to avoid strangulation. Keep floors and walkways free of cables to reduce the risk of tripping. WARNING: This monitor is not intended for use in an MR environment. WARNING: The Duo monitor is intended for hospital use under the direct supervision of a licensed health care practitioner. WARNING: Do not clean the monitor while it is ON and/or connected to AC power. WARNING: The Duo should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the Duo should be observed to verify normal operation in the configuration in which it will be used. WARNING: Operation of the Duo below the minimum amplitude or value of patient physiological signal may cause inaccurate results. WARNING: Use of accessories, transducers, and cables other than those specified in the manual may result in increased Electromagnetic Emissions or decreased Electromagnetic Immunity of the Duo. It can also cause delayed recovery after the discharge of a cardiac defibrillator. WARNING: Do not use a damaged or broken unit or accessory. Periodically, check all cables (e.g., AC line cord and patient connection cables) for damage that may occur through normal use. Replace cable if damaged in any way.

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 comprehensive listing of Duo Accessories refer to section 4.0, “Accessories.”

CAUTION:

The patient size selection should be matched to the actual patient before monitoring begins.

CAUTION:

Tissue damage or inaccurate measurement may be caused by incorrect SpO2 sensor application or use, such as wrapping too tightly, applying supplemental tape, failing to inspect the sensor site periodically or failing to position appropriately. Carefully read the SpO2 sensor directions and all precautionary information before use.

CAUTION:

Excessive ambient light may cause inaccurate SpO2 measurements. In such cases, cover the sensor site with opaque material.

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.

CAUTION:

This product contains natural rubber latex which may cause allergic reactions. This refers specifically to the large adult gray blood pressure cuff (0998-00-0003-35).

CAUTION:

If the device is accidently saturated with any liquid, immediately discontinue use and contact service personnel.

Duo™ Operating Instructions

0070-10-0603-01

v

Introduction

Precautions

CAUTION:

vi

Inaccurate SpO2 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 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 hypothermia, hypovolemia, severe vasoconstriction, reduced cardiac output, etc. These symptoms may cause a loss in vital sign readings.

CAUTION:

If the SpO2 sensor or patient cable are damaged in any way, discontinue use immediately. To prevent damage, do not soak or immerse the sensor in any liquid solution. Do not attempt to sterilize.

CAUTION:

When applying the SpO2 sensor to the patient, ensure proper positioning, alignment and skin integrity. Exercise 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 SpO2, 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.

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 SpO2 sensors, do not use an excessive amount of liquid. Wipe the sensor surface with a soft cloth, dampened with a cleaning solution.

CAUTION:

Do not subject the SpO2 sensor to autoclaving.

CAUTION:

Do not use SpO2 sensors or cables that are damaged or have deteriorated.

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 0146-000079 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 explanations are provided to assist in the identification and correction of problems that may occur with the monitor.

NOTE:

The comparison testing conducted via the auscultatory method used both Phase 4 and Phase 5 Korotkoff sounds. A report of the study finding for the auscultatory method is available by contacting Technical Support (201) 995-8116.

NOTE:

The use of this equipment is restricted to one patient at a time.

Indication for Use The Duo monitor is intended for use in 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 /

Type BF Equipment

Refer to Manual

Dangerous Voltage

Defibrillator Proof Type BF Equipment

Equipotentiality

Battery Charging

Alternating Current (AC)

NIBP

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

Patient Size (Adult/Pediatric)

Data Input/Output

Clear/Next Patient

Non-ionizing electromagnetic

Consult Operating

radiation

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.

x

0070-10-0603-01

Duo™ 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 SpO2 (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

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.

Sys. MAP Dia.

kPa NIBP

1

Source

SpO2

C

2

SpO2 ¨

3

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.

a

b

c

d

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 SpO2 (green LED).

•

The label for the unit of measure is bpm.

c. SpO2 (Optional) •

The SpO2 parameter tile is labeled SpO2. The LEDs are green.

•

The label for the unit of measure is %.

d. Information Codes

Duo™ Operating Instructions

•

Information and error codes are displayed in the window.

•

See section 2.4.1 for additional information.

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.

d a

b c

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 •

1-4

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”.

0070-10-0603-01

Duo™ Operating Instructions

General Product Description

Controls and Indicators

2. Keypad The Duo keypad (shown in FIGURE 1-4) is used to initiate all functions. To confirm that a key has been successfully activated, two forms of feedback are provided. Manual feedback is provided in the form of a “click” that can be felt under the fingertip. Audible feedback is provided in the form of a single beep tone when the operation associated with that key is executed.

d

a

b

c

FIGURE 1-4 Keypad a. Power ON/OFF •

NOTE:

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. 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 •

Duo™ Operating Instructions

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

0070-10-0603-01

1-5

Controls and Indicators

General Product Description

3. Connector Panel

2

b

a

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. SpO2 Receptacle (optional) •

*

1-6

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.

0070-10-0603-01

Duo™ Operating Instructions

General Product Description

1.2.2

Controls and Indicators

Rear Panel The rear panel provides a general information label, a serial port, an equipotential lug, an AC receptacle and a mounting alignment slot.

1

PN

2

SN

V 100 - 240~ IEC 601-1:1988 A 0.7 - 0.4 CSA - C22.2 No. 601.1 - M90 Hz 60 / 50 UL 2601-1:1997

0044

¨

3

4

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 This is the connector for the AC power cord. NOTE:

The power supply, and battery charger (if the battery is installed) are active any time AC power is supplied, regardless of whether the monitor is ON or OFF.

4. Mounting Alignment Slot This is used to align the Duo with the mounting plate on the optional rolling stand.

Duo™ Operating Instructions

0070-10-0603-01

1-7

Controls and Indicators

1.2.3

General Product Description

Bottom Panel The battery compartment and the mounting nut for the optional rolling stand are located on the bottom panel as shown in FIGURE 1-7.

a

b

FIGURE 1-7 Bottom Panel a. Mounting Nut •

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

b. Battery Compartment •

1-8

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.

0070-10-0603-01

Duo™ Operating Instructions