BCI BCI 3304 Oximeter Operators Manual Oximeter Clinician's Operation Manual Catalog Number: 1857E

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Page 1

Oximeter

98 80

b p m

% SpO2

PULSE VOLUME

ALARM VOLUME

SILENCE

LO BATT

ALARM

ARTIFACT SEARCH SENSOR

ALARM SELECT

ID CLEAR

O/I

98 80

SENSOR

b p m

% SpO2

Clinician’s Operation Manual

- English

Catalog Number 1857E

Version 12, February 2008

Page 2

Page 3

Table of Contents

Warranty and Service Information ......................................................................................... v

Proprietary Notice ....................................................................................................................................................................................v

Warranty ......................................................................................................................................................................................................v

Limited Warranty ..............................................................................................................................................................................v

Disclaimer of Warranties ................................................................................................................................................................v

Conditions of Warranty ..................................................................................................................................................................v

Limitation of Remedies ..................................................................................................................................................................v

Warranty Procedure ................................................................................................................................................................................vi

CE Notice ....................................................................................................................................................................................................vi

Chapter 1: Introduction .......................................................................................................1-1

About the Manual ................................................................................................................................................................................1-1

Deﬁnition of Symbols .........................................................................................................................................................................1-1

Warnings ..................................................................................................................................................................................................1-2

Cautions ...................................................................................................................................................................................................1-5

Notes .........................................................................................................................................................................................................1-5

Chapter 2: Intended Use and Monitor Features .................................................................2-1

Intended Use ..........................................................................................................................................................................................2-1

Monitor Features ..................................................................................................................................................................................2-1

Theory of Operation ............................................................................................................................................................................2-2

Chapter 3: Controls & Features ............................................................................................3-1

Monitor Front Panel .............................................................................................................................................................................3-1

Monitor Side Panel ...............................................................................................................................................................................3-3

Monitor Back Panel ..............................................................................................................................................................................3-4

Chapter 4: Operating Instructions ......................................................................................4-1

Unpacking the Monitor ......................................................................................................................................................................4-1

Attaching the Sensor to the Patient ..............................................................................................................................................4-1

Choosing the Sensor ..................................................................................................................................................................4-2

Care and Handling of the Sensor ...........................................................................................................................................4-2

Checking the Sensor and Oximetry Cable ..........................................................................................................................4-3

Cleaning or Disinfecting the Sensors ...................................................................................................................................4-4

Turning On the Monitor .....................................................................................................................................................................4-5

Alarms .......................................................................................................................................................................................................4-6

Alerts .........................................................................................................................................................................................................4-7

LO BATT Attention ................................................................................................................................................................................4-8

Checking the Monitor’s Performance ...........................................................................................................................................4-8

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Table of Contents

Chapter 5: Changing the Monitor’s Settings ......................................................................5-1

Silencing Alarm and Alert Tones .....................................................................................................................................................5-1

Changing the Alarm and Alert Tone Volume ..............................................................................................................................5-1

Adjusting the Brightness of the Display .......................................................................................................................................5-1

Changing the Pulse Beep Volume ..................................................................................................................................................5-1

Changing the Setup Modes ..............................................................................................................................................................5-1

Changing the Alarm Limits ...............................................................................................................................................................5-2

Chapter 6: Patient Numbers & Trend Data..........................................................................6-1

Description .............................................................................................................................................................................................6-1

Manually Incrementing the Patient Number .............................................................................................................................6-1

Adjusting The Data Storage Interval..............................................................................................................................................6-1

Clearing Trend Data .............................................................................................................................................................................6-1

Chapter 7: Printer .................................................................................................................7-1

Data Log Printout .........................................................................................................................................................................7-1

Compatible Printers .............................................................................................................................................................................7-2

What You’ll Need for Printing ...........................................................................................................................................................7-2

Setting Up the Monitor and the Printer .......................................................................................................................................7-3

Printing Data Log ..................................................................................................................................................................................7-4

Trend Printouts ......................................................................................................................................................................................7-4

Collecting Trend Data .................................................................................................................................................................7-4

Manually Incrementing the Patient Number .....................................................................................................................7-4

Clearing Trend Data ....................................................................................................................................................................7-5

Printing Trend Data .....................................................................................................................................................................7-5

PC Communication Setup .................................................................................................................................................................7-6

Transferring Data to a PC ...................................................................................................................................................................7-6

Chapter 8: Operating Modes ...............................................................................................8-1

About the Monitor’s Operating Modes ........................................................................................................................................8-1

Home Use Mode ...................................................................................................................................................................................8-1

Setting Up the Monitor for Home-Use .................................................................................................................................8-1

Equipment and Supplies Checklist for Home-Use ...................................................................................................................8-2

Training the Home-Use Caregiver ..................................................................................................................................................8-3

Turning Oﬀ Home-Use Mode ...........................................................................................................................................................8-4

Setting Up the Monitor for Sleep Study Mode ..........................................................................................................................8-4

Turning Oﬀ Sleep Study Mode ........................................................................................................................................................8-4

Chapter 9: Charging the Monitor ........................................................................................9-1

Chapter 10: Maintenance ...................................................................................................10-1

Schedule of Maintenance ............................................................................................................................................................... 10-1

Correcting the SENSOR Alert ......................................................................................................................................................... 10-1

ii Clinician’s Operation Manual

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Table of Contents

Chapter 11: Troubleshooting .............................................................................................11-1

Chapter 12: Optional Supplies & Accessories...................................................................12-1

Ordering Information ....................................................................................................................................................................... 12-1

Chapter 13: Speciﬁcations .................................................................................................13-1

Parameters Monitored ..................................................................................................................................................................... 13-1

Displays, Indicators, & Keys ............................................................................................................................................................ 13-1

SpO2 ........................................................................................................................................................................................................ 13-1

Sensors .................................................................................................................................................................................................. 13-1

Pulse Rate ............................................................................................................................................................................................. 13-2

Alarm Indicators ................................................................................................................................................................................. 13-2

Sensor Alert Indicator ......................................................................................................................................................................13-2

Printer Output ..................................................................................................................................................................................... 13-2

Battery ...................................................................................................................................................................................................13-2

AC Charger ........................................................................................................................................................................................... 13-2

Dimensions .......................................................................................................................................................................................... 13-2

Environmental Speciﬁcations .......................................................................................................................................................13-2

Appendix A: Outputs ........................................................................................................... A-1

Analog Outputs .................................................................................................................................................................................... A-1

Digital Outputs ..................................................................................................................................................................................... A-2

Appendix B: Guidance and Manufacturer’s Declaration .................................................. B-1

Guidance and Manufacturer’s Declaration .................................................................................................................................B-1

Electromagnetic Emissions - Emissions Test ......................................................................................................................B-1

Electromagnetic Emissions – Immunity ..............................................................................................................................B-1

Recommended Separation Distances ...........................................................................................................................................B-4

Appendix C: Revision History ..............................................................................................C-1

The product described is covered by one or more of the following: U.S. Patent No. 5,558,096 and 5,615,091.

BCI, Comfort Clip and the Smiths design mark are trademarks of the Smiths Medical family of companies. The symbol ® indicates the trademark is registered in the U.S. Patent and Trademark Oﬃce and certain other countries. All other names and marks mentioned are the trade names, trademarks or service marks of their respective owners.

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Table of Contents

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iv Clinician’s Operation Manual

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Warranty and Service Information

Proprietary Notice

Information contained in this document is copyrighted by Smiths Medical PM, Inc. and may not be duplicated in full or part by any person without prior written approval of Smiths Medical PM, Inc. Its purpose is to provide the user with adequately detailed documentation to eﬃciently install, operate, maintain, and order spare parts for the device supplied. All information contained in this document is believed to be current and accurate as of the date of publication or revision, but does not constitute a warranty.

Warranty

Limited Warranty

Smiths Medical PM, Inc. (“Seller”) warrants to the original purchaser that the Product, not including accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with its labeling, for two years from the date of shipment to the original purchaser.

Seller warrants to the original purchaser that the reusable oximeter sensors supplied as accessories, shall be free from defects in materials and workmanship under normal use, if used in accordance with its labeling, for one year from the date of shipment to the original purchaser (USA only).

Disclaimer of Warranties

THE FOREGOING EXPRESS WARRANTY, AS CONDITIONED AND LIMITED, IS IN LIEU OF AND EXCLUDES ALL OTHER WARRANTIES WHETHER EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

Seller disclaims responsibility for the suitability of the Product for any particular medical treatment or for any medical complications resulting from the use of the Product. This disclaimer is dictated by the many elements which are beyond Seller’s control, such as diagnosis of patient, conditions under which the Product may be used, handling of the Product after it leaves Seller’s possession, execution of recommended instructions for use and others.

Conditions of Warranty

This warranty is void if the Product has been altered, misused, damaged by neglect or accident, not properly maintained or recharged, or repaired by persons not authorized by Seller. Misuse includes, but is not limited to, use not in compliance with the labeling or use with accessories not manufactured by Seller. This warranty does not cover normal wear and tear and maintenance items.

Limitation of Remedies

The original purchaser’s exclusive remedy shall be, at Seller’s sole option, the repair or replacement of the Product. THIS IS THE EXCLUSIVE REMEDY. In no event will Seller’s liability arising out of any cause

whatsoever (whether such cause is based in contract, negligence, strict liability, tort or otherwise) exceed the price of the Product and in no event shall Seller be responsible for consequential, incidental or special damages of any kind or nature whatsoever, including but not limited to, lost business, revenues and proﬁts.

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Warranty and Service Information

Warranty Procedure

To obtain warranty service in the USA, you must request a Customer Service Report (CSR) number from Technical Service. Reference the CSR number when returning your Product, freight and insurance prepaid, to:

Smiths Medical PM, Inc. N7W22025 Johnson Drive Waukesha, WI 53186-1856

Seller will not be responsible for unauthorized returns or for loss or damage to the Product during the return shipment. The repaired or replaced Product will be shipped, freight prepaid, to Purchaser.

To obtain warranty service outside of the USA, contact your local distributor.

Keep all original packing material, including foam inserts. If you need to ship the device, use only the original packaging material, including inserts. Box and inserts should be in original condition. If original shipping material in good condition is not available, it should be purchased from Smiths Medical PM, Inc.

Damages occurred in transit in other than original shipping containers, are the responsibility of the shipper. All costs incurred returning devices for repair are the responsibility of the shipper.

Telephone: 262-542-3100 Toll Free: 1-800-558-2345 (USA only) Fax: 262-542-0718

CE Notice

Marking by the symbol 2 indicates compliance of this device to the Medical Device Directive 93/42/EEC.

Australian Representative:

Authorized European Representative (as deﬁned by the Medical Device Directive):

Smiths Medical International, Ltd. Colonial Way, Watford, Herts, WD24 4LG, UK

Smiths Medical Australasia Pty. Ltd. 61 Brandl Street, Eight Mile Plains, QLD 4113, Australia

Phone: (44) 1923 246434 Fax: (44) 1923 240273

Tel: +61 (0) 7 3340 1300

vi Clinician’s Operation Manual

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Chapter 1: Introduction

About the Manual

The Clinician’s Operation Manual provides installation, operation, and maintenance instructions for the healthcare professional trained in monitoring respiratory and cardiovascular activity. The manual depicts the two available front panels for the 3304.

The Home-Use Instruction Book provides operation and maintenance instructions for the home-use caregiver. The home-use caregiver is assumed to be trained in oximeter use by a doctor or other health-care professional. The Home-Use Instruction Book supplements, and does not replace, training provided by a health-care professional in oximeter use.

These instructions contain important information for safe use of the product. Read the entire contents of these Instructions For Use, including Warnings and Cautions, before using the monitor. Failure to properly follow warnings, cautions and instructions could result in death or serious injury to the patient.

Deﬁnition of Symbols

SYMBOL DEFINITION

%SpO2

Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.

Type CF equipment

Type B Equipment

Attention, see instructions for use.

Refer servicing to qualiﬁed service personnel.

Do not reuse. One use on one patient.

Percent Oxygen Saturation

Pulse Rate LED (beats per minute)

Alarm SILENCE

On/Oﬀ

Pulse Volume

Alarm Volume

Up and Down Arrows

Alarm Select

ID/CLEAR

Clinician’s Operation Manual 1-1

Moisture Sensitive

Non AP Device

Output Voltage

Input Voltage

Printer output

Direct Current

Speaker

Page 10

Chapter 1: Introduction

SYMBOL DEFINITION

Collect

Separately

KEYWORD

Catalog Number

Date of Manufacture

Disposal (EU Countries)

Under the Waste Electrical and Electronic Equipment (WEEE) Directive 2006/96/EC and implementing regulations, all devices and service items within the scope of the Directive purchased new after August 13, 2005 must be sent for recycling when ultimately becoming waste. Devices and items must not be disposed of with general waste.

If purchased before that date, they may also be sent for recycling if being replaced on a onefor-one, like-for-like basis (this varies depending on the country). Recycling instructions to customers using Smiths Medical products are published on the internet at:

http://www.smiths-medical.com/recycle Disposal (other countries)

When disposing of this device, its batteries or any of its accessories, ensure that any negative impact on the environment is minimized. Contact your local waste disposal service and use local recycling or disposal schemes. Separate any other parts of the equipment where arrangements can be made for their recovery; either by recycling or energy recovery. The main batteries are potentially harmful and will require separate disposal according to manufacturer’s instructions or local regulations.

Note: If applicable, EU, national or local regulations concerning waste disposal must take precedence over the above advice.

DEFINITION

WARNING

CAUTION

NOTE

Tells you about something that could hurt the patient or hurt the operator.

Tells you about something that could damage the monitor.

Tells you other important information.

Warnings

WARNING! Do not use this device in the presence of ﬂammable anesthetics.

WARNING! Do not use this device in the presence of magnetic resonance imaging (MR or MRI)

equipment.

WARNING! Operation of this device may be adversely aﬀected in the presence of conducted transients

or strong electromagnetic (EM) or radiofrequency (RF) sources, such as electrosurgery and electrocautery equipment, x-rays, and high intensity infrared radiation.

WARNING! Operation of this device may be adversely aﬀected in the presence of computed tomograph

(CT) equipment.

WARNING! Any monitor that has been dropped or damaged should be inspected by qualiﬁed service

personnel, prior to use, to insure proper operation.

WARNING! If the accuracy of any measurement is in question, verify the patient’s vital sign (s) by an

alternative method and then check the monitor for proper functioning.

WARNING! This device must be used in conjunction with clinical signs and symptoms. This device is only

intended to be an adjunct in patient assessment.

1-2 Clinician’s Operation Manual

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Chapter 1: Introduction

WARNING! This device is intended for use by persons trained in professional health care. The operator

must be thoroughly familiar with the information in this manual before using the device.

WARNING! It is the operator’s responsibility to set alarm limits appropriately for each individual patient.

WARNING! Prolonged use or the patient’s condition may require changing the sensor site periodically.

Change sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours.

WARNING! When attaching sensors with Microfoam® tape, do not stretch the tape or attach the tape too

tightly. Tape applied too tightly may cause inaccurate readings and blisters on the patient’s skin (lack of skin respiration, not heat, causes the blisters).

WARNING! Connect the Wall Mount Charger to grounded, three-wire outlet. Failure to comply may

compromise patient isolation.

WARNING! Patient safety can be compromised by the use of a power supply not supplied by Smiths

Medical PM, Inc. Use only the power supply included with your monitor, or approved by Smiths Medical PM, Inc.

WARNING! Verify the functionality of any remote alarm system connected to this monitor before leaving

the patient unattended.

WARNING! Use only SpO2 sensors supplied with, or speciﬁcally intended for use with, this device.

WARNING! SpO2 measurements may be adversely aﬀected in the presence of high ambient light. Shield

the sensor area (with a surgical towel, for example) if necessary.

WARNING! Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo

carmine, ﬂuorescein, and patent blue V (PBV) may adversely aﬀect the accuracy of the SpO2 reading.

WARNING! Any condition that restricts blood ﬂow, such as use of a blood pressure cuﬀ or extremes in

systemic vascular resistance, may cause an inability to determine accurate pulse rate and SpO2 readings.

WARNING! Optical cross-talk can occur when two or more sensors are placed in close proximity. It can be

eliminated by covering each site with an opaque material.

WARNING! Remove ﬁngernail polish or false ﬁngernails before applying SpO2 sensors. Fingernail polish

or false ﬁngernails may cause inaccurate SpO2 readings.

WARNING! Signiﬁcant levels of dysfunctional hemoglobins, such as carboxyhemoglobin (with CO-

poisoning) or methemoglobin (with sulfonamide therapy), will aﬀect the accuracy of the SpO2 measurement.

WARNING! Tissue damage may result from overexposure to sensor light during photodynamic therapy

with agents such as verteporphin, porﬁmer sodium, and metatetrahydroxyphenylchlorin (mTHPC). Change the sensor site at least every hour and observe for signs of tissue damage. More frequent sensor site changes/inspections may de indicated depending upon the photodynamic agent used, agent dose, skin condition, total exposure time or other factors. Use multiple sensor sites.

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Chapter 1: Introduction

R 1.5 m (4.

t.)

WARNING! When connecting this monitor to any instrument, verify proper operation before clinical use.

Refer to the instrument’s user manual for full instructions. Accessory equipment connected to the monitor’s data interface must be certiﬁed according to the respective IEC standards, i.e., IEC 950 for data processing equipment or IEC 601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC 601-1 systems requirements. Anyone connecting additional equipment to the signal input port or the signal output port conﬁgures a medical system, and therefore is responsible that the system complies with the requirements of the system standard IEC 601-1.

WARNING! IEC 950 approved equipment must be placed outside the “patient environment.” The patient

environment is deﬁned as an area 1.5 m (4.92 feet) from the patient.

Figure 1.1: Patient Environment

WARNING! Disconnect the AC power supply from the outlet before disconnecting it from the monitor.

Leaving the AC power supply connected to an AC power outlet without being connected to the monitor may result in a safety hazard.

WARNING! Do not allow any moisture to touch the AC power supply connectors or a safety hazard may

result. Ensure that hands are thoroughly dry before handling the AC power supply.

WARNING! Do not place the monitor in the patient’s bed or crib. Do not place the monitor on the ﬂoor.

WARNING! Failure to place the monitor away from the patient may allow the patient to turn oﬀ, reset, or

damage the monitor, possibly resulting in the patient not being monitored. Make sure the patient cannot reach the monitor from their bed or crib.

WARNING! Failure to carefully route the cable from the sensor to the monitor may allow the patient to

become entangled in the cable, possibly resulting in patient strangulation. Route the cable in a way that will prevent the patient from becoming entangled in the cable. If necessary, use tape to secure the cable.

WARNING! If there is a risk of the AC power supply becoming disconnected from the monitor during use,

secure the cord to the monitor several inches from the connection.

WARNING! Under certain clinical conditions, pulse oximeters may display dashes if unable to display

SpO2 and/or pulse rate values. Under these conditions, pulse oximeters may also display erroneous values. These conditions include, but are not limited to: patient motion, low perfusion, cardiac arrhythmias, hi or low pulse rates or a combination of the above conditions. Failure of the clinician to recognize the eﬀects of these conditions on pulse oximeter readings may result in patient injury.

WARNING! Verify that all LEDs (light emitting diodes) on the display light up upon startup of the device.

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Chapter 1: Introduction

Cautions

CAUTION! Do not disassemble unit, not user serviceable. 7 Refer to qualiﬁed service personnel.

CAUTION! The monitor is equipped with an internal rechargeable battery. Do not attempt to remove or

replace the internal rechargeable battery. Refer servicing to an authorized repair center.

CAUTION! Failure to charge the monitor while the monitor is not being used may shorten the battery life.

Charge the monitor while the monitor is not being used to ensure the longest battery life.

CAUTION! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid.

CAUTION! Do not allow water or any other liquid to spill onto the monitor. Do not autoclave, ethylene

oxide sterilize, or immerse the monitor in liquid. Evidence that liquid has been allowed to enter the monitor voids the warranty.

CAUTION! Chemicals used in some cleaning agents may cause brittleness of plastic parts. Follow

cleaning instructions in this manual.

CAUTION! Pressing front panel keys with sharp or pointed instruments may permanently damage the

keypad. Press front panel keys only with your ﬁnger.

Notes

NOTE! If the digital outputs are enabled and a low battery condition is present, the digital outputs will

be activated.

NOTE! “SpO2 averaging” means the number of pulse beats over which the SpO2 value is averaged; “pulse

averaging” means the number of seconds over which the pulse value is averaged.

NOTE! Increasing or decreasing the averaging setting has no eﬀect on the data update rate.

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Chapter 1: Introduction

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1-6 Clinician’s Operation Manual

Page 15

Chapter 2: Intended Use and Monitor Features

Intended Use

The 3304 Oximeter provides fast, reliable SpO2, pulse rate, and pulse strength measurements . It may be used in the hospital or clinical environment, during emergency air or land transport, or for in-home use. The oximeter will operate accurately over an ambient temperature range of 0 to 40 °C (32 to 104 °F). The oximeter works with all BCI® oximetry sensors providing SpO2 and pulse rate on all patients from neonate to adult (see section Choosing the Sensor under Attaching the Sensor to the Patient).

The oximeter permits patient monitoring with adjustable alarm limits as well as visible and audible alarm signals.

Monitor Features

Provides fast, reliable SpO2, pulse rate, and pulse strength measurements on any patient, from neonates

• to adults.

Ideally suited for use in intensive care units, outpatient clinics, emergency rooms, during emergency air or

• land transport, or for in-home use.

Portable and lightweight. Weighs only 850 grams (30 ounces).

•

Ergonomically designed to hang on a bed rail or be transported using the convenient handle.

•

Uses an internal, rechargeable battery.

•

Battery life is approximately 4.5 hours in continuous use (new). Battery fully charges in about 6 hours.

•

Bright, easy-to-read LED displays indicate SpO2 and pulse rate measurements. Brightness is

• user-adjustable.

A ten-segment LED bar graph indicates pulse strength.

•

Positive identiﬁcation of SpO2 or pulse rate alarm. Adjustable high and low alarm limits for SpO2 and

• pulse rate measurements.

Adjustable volume for alarm and alert tones (including silence).

•

Adjustable volume (including silence) “beep” sounds with each pulse beat. Pitch of pulse “beep”

• corresponds to SpO2 value.

User-adjustable delayed audible system alarms.

•

Low battery indicator lights when about 30 minutes of battery use remains.

•

Connects to an optional external printer or any RS-232 compatible terminal. Prints a continuous datalog

• and trend data in tabular format.

SpO2 and pulse rate averaging settings are user-selectable.

•

Artifact indicator informs user of excess motion and other artifacts.

•

Connects to optional analog output adapter, providing output of the monitor’s measured values.

•

Connects to optional digital alarm adapter to send output to a remote sensing location.

•

User-adjustable trend storage rate, ranging from 4 to 30 seconds per sample, for many applications

• including sleep studies.

Home-Use Mode allows a home-use caregiver to monitor a patient at home.

•

Clinician’s Operation Manual 2-1

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Chapter 2: Intended Use and Monitor Features

Theory of Operation

The pulse oximeter determines % SpO2 and pulse rate by passing two wavelengths of low intensity light, one red and one infrared, through body tissue to a photodetector. Information about wavelength range can be especially useful to clinicians. Wavelength information for this device can be found in the SpO2 Speciﬁcations section of this manual.

Pulse identiﬁcation is accomplished by using plethysmographic techniques, and oxygen saturation measurements are determined using spectrophotometric oximetry principles. During measurement, the signal strength resulting from each light source depends on the color and thickness of the body tissue, the sensor placement, the intensity of the light sources, and the absorption of the arterial and venous blood (including the time varying eﬀects of the pulse) in the body tissues.

Figure 2.1: SpO2 Theory Of Operation

Low intensity red and infrared LED light sources

Detector

Oximetry processes these signals, separating the time invariant parameters (tissue thickness, skin color, light intensity, and venous blood) from the time variant parameters (arterial volume and SpO2) to identify the pulses and calculate functional oxygen saturation. Oxygen saturation calculations can be performed because blood saturated with oxygen predictably absorbs less red light than oxygen-depleted blood.

WARNING! Since measurement of SpO2 depends on a pulsating vascular bed, any condition that restricts

blood ﬂow, such as use of a blood pressure cuﬀ or extremes in systemic vascular resistance, may cause an inability to determine accurate SpO2 and pulse rate readings.

WARNING! Under certain clinical conditions, pulse oximeters may display dashes if unable to display

SpO2 and/or pulse rate values. Under these conditions, pulse oximeters may also display erroneous values. These conditions include, but are not limited to: patient motion, low perfusion, cardiac arrhythmias, high or low pulse rates or a combination of the above conditions. Failure of the clinician to recognize the eﬀects of these conditions on pulse oximeter readings may result in patient injury.

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Chapter 3: Controls & Features

98 80

b p m

% SpO2

PULSE VOLUME

ALARM VOLUME

SILENCE

LO BATT

ALARM

ARTIFACT SEARCH SENSOR

ALARM SELECT

ID CLEAR

O/I

98 80

SENSOR

b p m

% SpO2

Monitor Front Panel

Figure 3.1: Domestic Display and Keypad

Chapter 3: Controls & Features

Figure 3.2: International (MDD) Display and Keypad

SpO2 Numeric Display

A number shows the patient’s SpO2 value in percent. Dashes (---) mean that the monitor is not able to calculate the SpO2 value.

Pulse Rate Numeric Display

A number shows the patient’s pulse rate value in beats per minute. Dashes (---) mean that the monitor is not able to calculate the pulse rate value.

Pulse Strength Bar Graph

The pulse strength bar graph “sweeps” with the patient’s pulse beat. The height of the bar graph tells the strength of the patient’s pulse.

Clinician’s Operation Manual 3-1

AC Power Indicator ( )

The AC Power Indicator is green when the power supply is attached.

Page 18

Chapter 3: Controls & Features

Alarm SILENCE Indicator (SILENCE g )

The alarm SILENCE indicator ( two minutes. The alarm SILENCE indicator ( indeﬁnitely (until canceled or until the monitor is turned oﬀ).

Artifact Indicator (ARTIFACT z)

The ARTIFACT indicator (z) is illuminated in the presence of excess motion or other artifacts.

Low Battery Indicator (LO BATT M )

The low battery indicator (M ) is illuminated and a short burst of beeps occurs when about 30 minutes of battery use remains. The monitor will work until the battery becomes very weak. When the battery becomes very weak, the monitor will turn itself oﬀ.

WARNING! When LO BATT (M ) ﬂashes, you must immediately charge the monitor’s battery. Otherwise,

the monitor turns itself oﬀ about 30 minutes after LO BATT begins to ﬂash.

SEARCHing Indicator (SEARCH B)

The SEARCHing light (B) indicates that the monitor is looking for a pulse. Audio pulse tone is disabled during this time.

Alarm Indicator (ALARM

The ALARM indicator (

) ﬂashes on and of when the alarm and alert tones are silenced for

) remains lit when the alarm and alert tones are silenced

) is illuminated during an alarm condition.

)

Sensor Indicator (SENSOR)

SENSOR lights when the sensor is not connected to the monitor, the sensor is not attached to the patient, or to indicate a “searching too long” warning.

WARNING! While SENSOR is lit, the monitor cannot measure the patient’s SpO2 or pulse rate. You must

immediately check the patient’s condition. After you have checked the patient’s condition, you must correct the SENSOR alert.

Alarm SILENCE (B )

Momentarily pressing the alarm silence key (B ) silences the alarm tone for two minutes. Pressing and holding the alarm silence key (B ) for about three seconds silences the alarm tone indeﬁnitely (until canceled or until the monitor is turned oﬀ). Pressing the alarm silence key (B ) when the alarms are silenced, activates the alarms.

Pulse Volume (

Pressing and holding the PULSE VOLUME key (K ) and simultaneously pressing the up or down arrow key, gradually changes the pulse beep volume.

NOTE! The pulse volume is stored after the monitor is turned oﬀ.

Device On/Oﬀ ( Q/R Domestic) (L MDD)

Pressing the on/oﬀ key turns the monitor on or oﬀ, depending on the previous condition.

Alarm Volume ( I )

Pressing and holding the ALARM VOLUME key (I) and simultaneously pressing the up or Down arrow key, gradually changes the alarm volume.

)

3-2 Clinician’s Operation Manual

Page 19

Chapter 3: Controls & Features

% SpO

Alarm Select (

Pressing the ALARM SELECT key ( holding at power up will start the setup mode.

UP arrow (n) Alarm Limit/Alarm Volume Adjustment/Brightness Adjustment

The up and down arrow keys are used to adjust up and down the following settings: brightness of the display; alarm limits; SpO2 and pulse rate averaging, data log and trend interval, RS-232 mode of operation, delayed audible system alarms, and alarm and pulse volume adjust.

DOWN arrow (o) Alarm Limit/Alarm Volume Adjustment/Brightness Adjustment

ID/CLEAR (J)

While the sensor is connected to the monitor pressing the I.D./CLEAR key (J) increases the patient number by one. The patient number is brieﬂy displayed in the SpO2 area. Pressing and holding the I.D/ CLEAR key (J) for about six seconds clears all trend data and sets the patient number to 1.

)

) cycles through each of the alarm limit settings. Pressing and

Monitor Side Panel

Figure 3.3: Side Panel Connectors

Sensor Connector

The sensor connects here. An oximetry cable, connecting the monitor and the sensor, is also connected here.

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Page 20

Chapter 3: Controls & Features

PRINTER OUTPUT 6 - 8V 0.35A

-----

- - -

ONLY USE BCI AC ADAPTER INPUT 12V 0.35A

-----

- - -

Monitor Back Panel

Figure 3.4: Back Panel Connectors

AC Power Connector

AC power supply connects here.

Printer/PC Connector

An optional printer can be connected for printing trend and datalog data. See the Printer section for more printer options. The monitor may also be connected to a PC using this connector.

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Chapter 4: Operating Instructions

Unpacking the Monitor

Carefully remove the monitor and its accessories from the shipping carton. Save the packing materials in case the monitor must be shipped or stored.

Compare the packing list with the supplies and equipment you received to make sure you have everything you’ll need.

Attaching the Sensor to the Patient

What you need to know about attaching the sensor to the patient:

WARNING! Incorrectly applied sensors may give inaccurate readings. 2 Refer to the sensor insert for

proper application instructions.

WARNING! Prolonged use or the patient’s condition may require changing the sensor site periodically.

Change sensor site and check skin integrity, circulatory status, and correct alignment at least every 4 hours.

WARNING! When attaching sensors with Microfoam® tape, do not stretch the tape or attach the tape too

tightly. Tape applied too tightly may cause inaccurate readings and blisters on the patient’s skin (lack of skin respiration, not heat, causes the blisters).

To attach the patient to the monitor:

Choose the sensor.

Check the sensor and oximetry cable.

Clean or disinfect the sensor if using the reusable type. (Disposable sensors are for single-patient use and do

not require cleaning or disinfecting.) (See Cleaning or Disinfecting the Sensors section in this chapter for more information.)

Attach the sensor to the patient.

WARNING! Do not place the monitor in the patient’s bed or crib. Do not place the monitor on the ﬂoor.

WARNING! Failure to place the monitor away from the patient may allow the patient to turn oﬀ, reset, or

damage the monitor, possibly resulting in the patient not being monitored. Make sure the patient cannot reach the monitor from their bed or crib.

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Chapter 4: Operating Instructions

b p m

% SpO2

PULSE VOLUME

ALARM VOLUME

ALARM SELECT

ID CLEAR

O/I

Choosing the Sensor

Choose the appropriate sensor from the following chart.

PATIENT SITE DESCRIPTION

Adult over 45 kg

Finger

3044: Sensor, Adult (reusable) 3444: Sensor Comfort Clip® (reusable)

Finger or Toe

Ear

Pediatric

Finger

15-45 kg

Finger or Toe

Ear

Infant

Hand or Foot

3-15 kg

Toe

Finger or Toe

Neonate

Hand or Foot

under 3 kg

Foot

Care and Handling of the Sensor

3043: Sensor, Universal ‘Y’ (reusable) 1300: Sensor, Disposable, Adult Finger

3078: Sensor, Ear (reusable)

3044: Sensor, Adult (reusable) (>20 kg) 3444: Sensor Comfort Clip® (reusable) 3178: Sensor, Pediatric Finger (5-45 kg)

3043: Sensor, Universal ‘Y’ (reusable) 1301: Sensor, Disposable, Ped. Finger 7

3078: Sensor, Ear (reusable)

3043: Sensor, Universal ‘Y’ (reusable)

3025: Sensor, Wrap, Infant (reusable)

1303: Sensor, Disposable, Infant 7

1302: Sensor, Disposable, Neonate 7

3026: Sensor, Wrap, Neonate (reusable)

WARNING! Misuse or improper handling of the sensor and cable could result in damaging of the sensor.

This may cause inaccurate readings.

Hold the connector rather than the cable when connecting or disconnecting the ﬁnger sensor to the device as shown in Figure 4.1.

Figure 4.1: Disconnecting or connecting the ﬁnger sensor.

Connector

Sensor (ﬁnger sensor shown for illustration only)

Do not use excessive force or unnecessary twisting when connecting, disconnecting, storing, or when using the sensor.

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Chapter 4: Operating Instructions

b p m

% SpO2

PULSE VOLUME

ALARM VOLUME

ALARM SELECT

ID CLEAR

O/I

When placing the sensor on the patient, allow the cable to lay across the top of the hand and parallel to the arm of the patient as shown in Figure 4.2.

Figure 4.2: Positioning the cable of the ﬁnger sensor.

Sensor (ﬁnger sensor shown for illustration only)

Cable

Upon completion of patient monitoring, detach the sensor as shown in Figure 4.1 and loosely coil the ﬁnger sensor cable.

Checking the Sensor and Oximetry Cable

Follow these instructions each time before you attach the sensor to the patient. This helps ensure the sensor and oximetry cable are working properly.

WARNING! Using a damaged sensor may cause inaccurate readings. Inspect each sensor. If a sensor

appears damaged, do not use it. Use another sensor or contact your authorized repair center for help.

WARNING! Using a damaged oximetry cable may cause inaccurate readings. Inspect the oximetry cable.

If the oximetry cable appears damaged, do not use it. Contact your authorized repair center for help.

Carefully inspect the sensor to make sure it does not appear damaged.

If using the oximetry cable, carefully inspect the oximetry cable to make sure it does not appear damaged.

Figure 4.3: Attaching Sensor And Oximetry Cable To Monitor.

Oximetry Cable

Connector Retaining Clip

Sensor (Finger Sensor shown for illustration only)

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Page 24

Chapter 4: Operating Instructions

If using the oximetry cable:

If the sensor is not already connected to the oximetry cable, connect the sensor to the oximetry cable as

1. shown. Push the connectors together ﬁrmly and close the latch to secure the connectors.

If the oximetry cable is not already connected to the monitor, connect the oximetry cable to the monitor as

2. shown. Push the connector ﬁrmly into the monitor.

You are now ready to attach the sensor to the patient.

WARNING! Failure to carefully route the cable from the sensor to the monitor may allow the patient to

If not using the oximetry cable:

Connect the sensor to the monitor. Push the connector ﬁrmly into the monitor.

WARNING! If any of the integrity checks fail, do not attempt to monitor the patient. Use another sensor

or oximetry cable, or contact the equipment dealer for help if necessary.

Before the sensor is attached to the patient, check the integrity of the sensor, oximetry cable, and oximeter

2. as follows:

Make sure the red light in the sensor is illuminated.

Make sure the SENSOR indicator is lit as follows:

For ‘Y’ sensors, wrap sensors, and disposable sensors: Align the sensor’s red light with the detector so

• they are less than 1/8 inch away from each other. Make sure the SENSOR indicator is lit on the oximeter.

For the ﬁnger sensor and ear sensor: Make sure the SENSOR indicator is lit on the oximeter.

•

NOTE! Obstructions or dirt on the sensor’s red light or detector may cause the checks to fail. Make sure

there are no obstructions and the sensor is clean.

You are now ready to attach the sensor to the patient.

Cleaning or Disinfecting the Sensors

Clean or disinfect reusable sensors before attaching to a new patient.

WARNING! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid.

CAUTION! Unplug the sensor from the monitor before cleaning or disinfecting.

Clean the sensor with a soft cloth moistened in water or a mild soap solution. To disinfect the sensor, wipe the sensor with isopropyl alcohol.

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Chapter 4: Operating Instructions

98 80

SENSOR

b p m

% SpO2

Turning On the Monitor

To turn on the monitor, press the on/oﬀ key (Q/R domestic) (L MDD). When turned on, the monitor does the

following:

The pulse strength bar graph segments light one at a time.

•

The monitor’s software revision is momentarily displayed.

•

The patient number is momentarily displayed.

•

WARNING! Verify that all LEDs (light emitting diodes) on the display light up upon startup of the device.

Figure 4.4: SpO2, Pulse Rate, And Pulse Strength Bar Graph.

1 2

Patient’s SpO

Patient’s Pulse Rate

Patient’s Pulse Strength

After a few seconds the % SpO2 value, pulse rate, and pulse strength bar graph should be shown. If not, see the Troubleshooting section for help.

The monitor has available three averaging settings for SpO2 and pulse. To change the averaging setting, press and hold the appropriate key while turning on the monitor as shown in the following chart:

POWER UP KEY PRESS

n o

NO KEYS PRESSED (Default) 8 8

SPO2 AVERAGING

16 16

4 8

PULSE AVERAGING

NOTE! SpO2 averaging is the number of pulse beats over which the SpO2 value is averaged; pulse

averaging is the number of seconds over which the pulse value is averaged.

NOTE! Averaging returns to the default setting each time the monitor is turned on.

NOTE! Increasing or decreasing the averaging setting has no eﬀect on the data update rate.

WARNING! Do not place the monitor in the patient’s bed or crib. Do not place the monitor on the ﬂoor.

WARNING! Failure to place the monitor away from the patient may allow the patient to turn oﬀ, reset, or

damage the monitor, possibly resulting in the patient not being monitored. Make sure the

Clinician’s Operation Manual 4-5

patient cannot reach the monitor from their bed or crib.

Page 26

Chapter 4: Operating Instructions

120

b p m

% SpO2

PULSE VOLUME

ALARM VOLUME

ALARM

ALARM SELECT

ID CLEAR

O/I

Alarms

Alarms warn you about an abnormal patient condition.

An alarm turns on when:

the patient’s SpO2 reading matches or exceeds the SpO2 alarm range.

•

the patient’s pulse rate reading matches or exceeds the pulse rate alarm range.

•

there is a lost pulse condition (the sensor no longer detects a pulse while a ﬁnger is inserted in the sensor,

• when a pulse was previously detected).

Figure 4.5: Alarm Example

During an alarm: the numbers ﬂash that correspond to the alarm.

During an alarm: ALARM LED (c) ﬂashes

During an alarm, the alarm tone sounds, if not silenced. The alarm tone consists of two bursts of ﬁve monotone beeps, repeated every 10 seconds.

NOTE! Both the SpO2 and pulse rate numbers will ﬂash if both readings match or go beyond their alarm

range.

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Page 27

Alerts

--- ---

b p m

% SpO2

PULSE VOLUME

ALARM VOLUME

SILENCE

SENSOR

ALARM SELECT

ID CLEAR

O/I

An alert warns you about an abnormal monitor condition.

An alert turns on when:

the sensor is not connected to the monitor.

•

the sensor is not attached to the patient.

•

the sensor is not properly attached to the patient.

•

Figure 4.6: Alert Example

Chapter 4: Operating Instructions

During an alert, the SENSOR message illuminates.

During an alert, the alert tone sounds, if not silenced (SILENCE or g). The alert sound is a single

tone pair of beeps with a 20 second pause: beep beep, pause, beep beep.

During an alert, the monitor cannot measure the patients SpO2 or pulse rate. Dashes are displayed.

WARNING! While SENSOR is lit, the monitor cannot measure the patient’s SpO2 or pulse rate. You must

immediately check the patient’s condition. After you have checked the patient’s condition, you must correct the SENSOR alert. See Correcting the SENSOR Alert in the Maintenance section for help.

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Page 28

Chapter 4: Operating Instructions

--- ---

b p m

% SpO2

PULSE VOLUME

ALARM VOLUME

LO BATT

ALARM SELECT

ID CLEAR

O/I

LO BATT Attention

Figure 4.7: BATT Attention Example

During the Low Battery attention, the low battery indicator (LO BATT or M) ﬂashes on and oﬀ. A

short burst of ﬁve beeps sounds every 30 seconds.

WARNING! When LO BATT indicator (M) ﬂashes, you must immediately charge the monitor’s battery.

Otherwise, the monitor turns itself oﬀ about 30 minutes after LO BATT (M) begins to ﬂash.

See LO BATT attention in the Troubleshooting section for help.

NOTE! If the digital outputs are enabled and a low battery condition is present, the digital outputs will

be activated.

Checking the Monitor’s Performance

Pulse oximeters do not require user calibration. If checking the function of the device is desired, an optional Oximetry Patient Simulator (Smiths Medical PM, Inc. catalog number 1606) is available as an accessory. The simulator attaches to the oximeter in place of the sensor or oximetry cable. It provides a known SpO2 and pulse rate signal to the oximeter. This allows the oximeter’s performance to be checked.

NOTE! The 1606 Oximetry Patient Simulator does not calibrate the monitor; the monitor does not

require calibration. The 1606 provides a known SpO2 and pulse rate to the monitor that allows you to check the monitor’s performance.

NOTE! The 1606 Oximetry/ECG Patient Simulator cannot be used to assess the accuracy of a pulse

oximeter and/or sensor.

NOTE! 2 Follow the instructions included with the Oximetry Patient Simulator.

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Page 29

Chapter 5: Changing the Monitor’s Settings

Silencing Alarm and Alert Tones

The alarm and alert tones can be silenced for two minutes or indeﬁnitely (until canceled or until the monitor is turned oﬀ).

To silence the alarm and alert tones for two minutes, momentarily press the alarm silence key (B ). If alarm and alert tones were already silenced, you must press the alarm silence key (B ) again. The alarm SILENCE indicator (

) ﬂashes during the two-minute time-out.

To silence the alarm and alert tones indeﬁnitely, press and hold the alarm silence key (B ) for about three seconds. The alarm SILENCE indicator (

To cancel either the indeﬁnite or the two-minute alarm and alert tone silenced condition, momentarily press alarm silence key (B ); the alarm silenced indicator turns oﬀ.

Changing the Alarm and Alert Tone Volume

The alarm and alert tones sound, ranging in volume from soft or loud (and vice versa).

) lights steady while alarms are silenced indeﬁnitely.

To change from soft to loud volume, press and hold the ALARM VOLUME key (I) while pressing the up and down arrow keys (n and o).

Adjusting the Brightness of the Display

WARNING! Adjusting the display too dim may cause the display to be diﬃcult to read in bright light.

Make sure the display is bright enough to be seen under all light conditions.

Use the n and o keys to change the brightness of the display:

To increase the brightness of the display, press the n key.

•

To decrease the brightness of the display, press the o key.

•

Changing the Pulse Beep Volume

A “beep” tone sounds with each pulse beat. To change from soft to loud volume, press and hold the PULSE VOLUME key (K ) while pressing the up or down arrow key (n and o).

Changing the Setup Modes

The following modes are user adjustable:

trend storage interval mode: 4 to 30 seconds

•

RS-232 output mode: printer, analog, digital

•

audible system alarms disable interval mode: OFF, 15, 30, or 45 seconds.

•

To change the default settings press and hold the ALARM SELECT key ( be adjusted using the up and down arrow keys (n and o). Switching from one mode to another is done by pressing the ALARM SELECT key (

The ﬁrst option of the setup mode is the trend storage interval. Use the up and down arrow keys (n and o) to change the interval at which trend data is stored from 4 to 30 seconds.

Clinician’s Operation Manual 5-1

) during power-up. Each mode may

Page 30

Chapter 5: Changing the Monitor’s Settings

Pressing ALARM SELECT ( analog (A), and digital (d).

Pressing ALARM SELECT ( 15, 30, and 45 seconds. When delay is oﬀ, the system alerts will be activated after 20 seconds of searching. This search time can be increased by increasing the delay.

Pressing ALARM SELECT (

) then gives the option to change the RS-232 output mode between printer (P),

) again, gives the option to adjust the audible system alarms delay between oﬀ,

) again saves the setup changes and exits setup mode.

Changing the Alarm Limits

Each measurement, SpO2 and Rate, has a high and low alarm limit setting.

Press the ALARM SELECT key ( down key (n and o) to increase or decrease the setting.

ALARM SEL KEY PRESS DISPLAY ALARM LIMIT

First press.

Second press.

Third press.

Fourth press.

Fifth press.

) until the alarm limit you want to change is shown, then press the up or

--- KI

85 Lo

Ki 155

Lo 50

97 74

- - - = High SpO2 alarm limit. (Example only.)

85 = Low SpO2 alarm limit. (Example only.)

155 = High pulse rate alarm limit. (Example only.)

50 = Low pulse rate alarm limit. (Example only.)

97 = SpO2 measurement. (Example only.) 74 = Pulse rate measurement. (Example only.)

NOTE! “ – – – ” in the display means the limit is set to oﬀ.

NOTE! Alarm limits are non-overlapping. You cannot set the high alarm equal to or lower than the low

alarm and you cannot set the low alarm equal to or higher than the high alarm.

NOTE! Alarm limits are retained during power cycles, except for the following note.

NOTE! If either the low or high SpO2 alarm limit is set below 80%, it will reset to 85% or higher when the

monitor is next powered on.

NOTE! While setting alarm limits, if no keys are pressed for twenty seconds, the alarm limit setting mode

is exited and the SpO2 and pulse rate measurements are shown.

NOTE! Alarms are not active while setting alarm limits; however, alarms are active as soon as you exit the

alarm limit setting mode.

NOTE! The alarm actions occur for each violated alarm, even if more than one alarm is violated at the

same time.

NOTE! Alarms may be tested while the monitor is in use by setting alarm limits such that the measured

parameter is outside alarm limits. Return limits to the required settings after testing.

WARNING! To avoid confusion, be aware of alarm limits of similar monitors in the same area when

adjusting alarm limits of this device.

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Page 31

Chapter 6: Patient Numbers & Trend Data

Description

Whenever the monitor is on, it stores one SpO2 and one pulse rate reading every four (4) to thirty (30) seconds. These intervals are adjustable as described later in this chapter. The stored readings are called trend data. The monitor remembers trend data for up to 99 patients and 90 hours of run-time.

Trend data is saved for each patient number. When you turn on the monitor, the patient number is automatically incremented and displayed during the power-up sequence if valid trend data was collected from the previous patient. If no valid trend data was collected from the previous patient, only the patient number is displayed and is not incremented.

Trend data for all patients can be printed on the optional printer.

NOTE! See Printer section for information on printing trend data.

Manually Incrementing the Patient Number

The SpO2 sensor must be connected to the monitor. If the SpO2 sensor is not connected to the monitor, connect the SpO2 sensor.

Press the I.D./CLEAR key (J ) to increment the patient number. The new patient number is momentarily displayed and trend data for the new patient is automatically saved

Adjusting The Data Storage Interval

Press and hold the ALARM SELECT key (

The data storage interval will appear on the display, showing the default interval of 30 seconds.

Use the up or down keys (n and o) to increase or decrease the storage interval. The interval range is 4 seconds to 30 seconds.

STORAGE INTERVAL SECONDS RUNTIME HOURS

4 12

5 15

8 24

10 30

20 60

30 90

) during power-up.

Clearing Trend Data

The SpO2 sensor must be connected to the monitor. If necessary, connect the SpO2 sensor to the monitor.

Press and hold the I.D./CLEAR key (J) for about six seconds. While you are holding the I.D./CLEAR key (J), the message trend data is cleared, the display shows P1.

Clinician’s Operation Manual 6-1

ﬂashes on the display to tell you the trend data for all patients is about to be cleared. When the

[{r

Page 32

Chapter 6: Patient Numbers & Trend Data

This page is intentionally left blank.

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Page 33

Chapter 7: Printer

Description

The 3304 has a built-in interface for an external printer. An external printer or PC may be connected to the Printer/PC connector on the back of the monitor.

Data Log Printout

Figure 7.1: Sample Data Log Printout

************************ DATA LOG

ID______________________ ________________________ SpO2 BPM

-- - 97% 91bpm 97% 83bpm 97% 87bpm 97% 88bpm 96% 88bpm 96% 92bpm 97% 88bpm 97% 87bpm 97% 83bpm 97% 80bpm 98% 80bpm 98% 80bpm 98% 80bpm 98% 84bpm 98% 84bpm

-- --

In the data log mode, the patient’s SpO2 and pulse rate values are printed in real time, once every ﬁve (5) seconds.

Figure 7.2: Sample Trend Printout

************************ TREND

PN 01 H :M :S SpO2 BPM 00:00:00 98% 60bpm 00:00:30 98% 60bpm 00:01:00 98% 60bpm

PN 02 H :M :S SpO2 BPM 00:00:00 98% 60bpm A 00:00:30 90% 94bpm

PN 03 H :M :S SpO2 BPM 00:00:00 89% 51bpm A 00:00:30 88% 45bpm

PN 04 H :M :S SpO2 BPM 00:00:00 88% 45bpm

PN 05 H :M :S SpO2 BPM 00:00:00 -- --

Whenever the monitor is on, it stores one SpO2 and pulse rate reading every four (4) to thirty (30) seconds, depending on the user’s needs (See the Adjusting the Data Storage Interval section). A thirty second interval is the default setting. The trend data can be printed at any time on the optional printer.

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Page 34

Chapter 7: Printer

R 1.5 m (4.

t.)

Compatible Printers

Printer requirements:

FUNCTION SPECIFICATION

I/O Port Serial RS-232C

Data Type ASCII

Data Format 9600 baud, 1 start bit, 8 data bits, 1 stop bit, no parity

I/O Connector Standard DB-9 Null Modem

Approvals IEC 950 / IEC 601-1

WARNING! When connecting this monitor to any instrument, verify proper operation before clinical use.

Refer to the instrument’s user manual for full instructions. Accessory equipment connected to the monitor’s data interface must be certiﬁed according to the respective IEC standards, i.e., IEC 950 for data-processing equipment or IEC 601-1 for electromedical equipment. All combinations of equipment must be in compliance with IEC 601-1-1 systems requirements. Anyone connecting additional equipment to the signal input port or signal output port conﬁgures a medical system, and, therefore, is responsible that the system complies with the requirements of the system standard IEC 601-1-1.

What You’ll Need for Printing

You’ll need these items to print trend printouts:

Oximeter

•

Printer Cable (see the Optional Supplies and Accessories section for ordering information).

•

Compatible printer (purchased from one of the printer manufacturer’s distributors).

•

Accessories required for the printer, such as paper, power supply or charger, adapter (i.e. DB-9 to DB-25

• standard adapter for use with DPU 411 printer), and so on (purchased from the printer manufacturer’s distributor).

WARNING! IEC 950 approved equipment must by placed outside of the “patient environment.” The

patient environment is deﬁned as an area 1.5 m (4.92 feet) from the patient.

Figure 7.3: Patient Environment

7-2 Clinician’s Operation Manual

Page 35

Setting Up the Monitor and the Printer

PRINTER OUTPUT 6 - 8V 0.35A

-----

- - -

ONLY USE BCI AC ADAPTER INPUT 12V 0.35A

-----

- - -

Figure 7.4: Setting Up The Oximeter And The Printer.

Chapter 7: Printer

Printer/PC Connector

Printer Cable (Catalog #3361)

Printer AC Power Connection

Optional Printer

DB-9 Printer Connector

Turn the monitor on and select PRINTER output mode:

Press the ALARM SELECT key (

Using the ALARM SELECT key (

) during power-up. The adjustable setup modes are displayed.

), select the OUT mode and press the up key (n)to choose “P”

(PRINTER).

Press the ALARM SELECT key (

) again until the patient number is displayed.

NOTE! If the LO BATT indicator (M) is lit, connect the monitor to the wall mount charger.

Refer to the printer’s operation manual and make sure the printer’s RS-232 data format is set up as follows:

Data Type: ASCII

•

Data Format: 9600 baud, 1 start bit, 8 data bits, 1 stop bit, no parity

•

Connect the printer cable’s DB-9 connector to the mating connector on the monitor.

Connect the printer cable’s DB-9 connector to the mating connector on the printer.

Connect the printer’s power source to the printer as described in the printer’s operation manual.

Make sure the printer has paper loaded and is ready to print as described in the printer’s operation manual.

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Page 36

Chapter 7: Printer

Printing Data Log

Set up the monitor and printer as previously

1. described.

Connect the SpO2 sensor to the patient and to the

2. monitor as previously described.

Turn on the printer.

Turn on the monitor. The monitor prints SpO2 and

4. pulse rate measurement once every ﬁve (5) seconds, as shown in the sample printout.

Pressing I.D./CLEAR key (J) prints a new header

5. and increments the patient number; real-time data is printed once every ﬁve (5) seconds again.

The monitor continues to store trend data, even while

6. printing the data log.

Dashes indicate invalid or unavailable data (for

7. example, the patient’s ﬁnger was removed from the SpO2 sensor).

If you disconnect the SpO2 sensor while printing the

8. data log, the data log printout continues (dashes are printed to indicate invalid or unavailable data). The data log continues to print until the monitor is turned oﬀ.

Figure 7.5: Printing Data Log

************************ DATA LOG ID______________________ ________________________ SpO2 BPM

-- --

-- 60bpm

-- 65bpm 98% 68bpm 97% 76bpm 98% 79bpm 98% 78bpm ************************

DATA LOG ID______________________ ________________________ SpO2 BPM

-- --

-- 62bpm

-- 62bpm 94% 65bpm 95% 68bpm

Monitor is turned on with SpO2 probe

connected to monitor; a header is printed.

First Real-Time Data is printed immediately

after header.

Real-Time Data ia printed once every ﬁve seconds.

Pressing the I.D./CLEAR key causes another header to be printed; Real-Time Data is printed once every ﬁve seconds.

NOTE! If unexpected characters or question marks are

printed, turn the printer oﬀ and on to reset the

Note that the patient number is incremented also and the monitor continues to store trend data even when printing the data log.

printer.

Trend Printouts

Collecting Trend Data

Whenever the monitor is on, it stores one SpO2 and one pulse rate reading every four (4) to thirty (30) seconds, as set during power-up (See the Adjusting the Data Storage Interval section). The stored readings are called trend data. The monitor remembers trend data for up to 99 patients and 90 hours of run-time (data storage interval set to 30 seconds). The trend data can then be printed at any time on the optional printer.

Trend data is saved for each patient number. When you turn on the monitor, the patient number is automatically incremented and displayed during the power-up sequence if valid trend data was collected from the previous patient. If no valid trend data was collected from the previous patient, the patient number is displayed only and is not incremented.

Manually Incrementing the Patient Number

The SpO2 sensor must be connected to the monitor. If necessary, connect the SpO2 sensor to the monitor.

Press the I.D./CLEAR key (J) to increment the patient number. The new patient number is momentarily

2. displayed and trend data for the new patient is automatically saved.

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Chapter 7: Printer

Clearing Trend Data

The SpO2 sensor must be connected to the monitor. If necessary, connect the SpO2 sensor to the monitor.

Press and hold the I.D./CLEAR key (J) for about six seconds. While you are holding the I.D./CLEAR key (J),

2. the message

ﬂashes on the display to tell you the trend data for all patients is about to be cleared.

[{r

When the trend data is cleared, the display shows P1.

Printing Trend Data

Set up the monitor and printer as previously described.

Disconnect the SpO2 sensor from the monitor.

Turn on the printer.

Turn on the monitor. The monitor prints the trend data for

4. each patient, from patients 1-99, as shown in the sample printout.

If there is no trend data at all, the message “ **** ” is

5. printed. If no valid data is collected for a patient number,

-- is printed.

If valid data is collected for a patient number for less than

6. one minute, only the last measurement is printed.

If data is collected for a patient number for more than one

7. minute, the relative time since the ﬁrst measurement is shown for that patient.

Figure 7.6: Printing Trend Data

************************ TREND

PN 01 H :M :S SpO2 BPM 00:00:00 98% 60bpm 00:00:30 98% 60bpm

00:01:00 98% 60bpm

PN 02 H :M :S SpO2 BPM 00:00:00 98% 60bpm A 00:00:30 90% 94bpm

PN 03 H :M :S SpO2 BPM 00:00:00 89% 51bpm A 00:00:30 88% 45bpm

PN 04 H :M :S SpO2 BPM 00:00:00 88% 45bpm

PN 05 H :M :S SpO2 BPM 00:00:00 -- 45bpm

Dashes indicate invalid or unavailable data (for example,

8. the patient’s ﬁnger was removed from the SpO2 sensor).

A printed ‘A’ indicates the presence of artifact in the signal.

9. A printed ‘L’ indicates a low pulse

If you connect the SpO2 sensor while printing trend

10. data, the trend printout continues. If the SpO2 sensor is connected to the monitor after all trend data for all patient numbers has been printed, a data log printout starts.

If you press the I.D./CLEAR key (J) while printing trend

11. data, the trend printout stops and a data log printout

Monitor is turned on with SpO2 probe disconnected from monitor:; the trend printout is started.

The trend printout shows the relative

time since the ﬁrst measurement for that patient number.

Data was collected from patient number 05 for less than one minute; only the last measurement is printed. Dashes indicate invalid or unavailable data (for example, the patient’s ﬁnger was removed from the SpO2 probe.

starts. Pressing the I.D./CLEAR key (J) also increments the patient number, and trend data is collected for the new patient number while the data log is printing.

NOTE! If unexpected characters or question marks are printed, turn the printer oﬀ and on to reset the

printer.

Clinician’s Operation Manual 7-5

Page 38

Chapter 7: Printer

PRINTER OUTPUT 6 - 8V 0.35A

-----

- - -

ONLY USE BCI AC ADAPTER INPUT 12V 0.35A

-----

- - -

PC Communication Setup

Figure 7.7: Setting Up The Oximeter And The PC.

Printer/PC Connector

DB-9 Straight Through cable (Catalog #3362)

DB-9 PC Serial Connector

PC AC Power Connection

Power up the monitor. Make sure that the PRINTER output mode is selected (see the Setting Up the Monitor

and the Printer section.)

Set up the communication software to accept the following RS-232 data format :

Data Type: ASCII

•

Data Format: 9600 baud, 1 start bit, 8 data bits, 1 stop bit, no parity

•

Connect the PC cable’s (Catalog # 3362) DB-9 connector to the mating connector of the monitor.

Connect the PC cable’s (Catalog # 3362) DB-9 connector to the mating connector on the PC.

Transferring Data to a PC

Set up the monitor, cables, and PC as previously described.

Turn on the PC and load the communication software, setting the serial communication defaults as

2. previously described.

Turn on the monitor.

To output trend data, disconnect the SpO2 sensor, otherwise, connect the sensor to output a data log.

Dashes indicate invalid or unavailable data (for example, the patient’s ﬁnger was removed from the SpO2

5. sensor).

If the SpO2 sensor is reconnected while the trend data is being output to the PC, the output continues. If the

6. SpO2 sensor is reconnected to the monitor after all of the trend data has been output, a data log output will start.

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Chapter 8: Operating Modes

About the Monitor’s Operating Modes

The monitor has three operating modes: clinician mode (previously described), home-use mode, and the sleep study mode.

The clinician mode is intended for health-care professionals trained in monitoring respiratory and

• cardiovascular activity.

The home-use mode is intended for caregivers trained in oximeter use by a doctor or other health-care

• professional.

The sleep study mode is intended for health-care professionals trained in monitoring respiratory and

• cardiovascular activity.

While the monitor is in the clinician mode, all monitor functions operate as described previously in this manual.

Home Use Mode

While the monitor is in home-use mode:

Alarm limits can be viewed but cannot be changed.

•

Alarm and alert tones may not be adjusted.

•

Alarm and alert tones can be silenced for two minutes but cannot be silenced indeﬁnitely.

•

SpO2 averaging is set to 8 beats; pulse rate averaging is set to 8 seconds.

•

Patient number advancement is disabled.

•

Trend data is collected for one patient.

•

Trend data from the patient can be printed. The printout is the same as during clinician mode, except

• “Home Mode” replaces “Patient Number” on the printout.

Interval and delayed audio system alarm setup options are disabled.

•

All other functions of the monitor work as in clinician mode.

•

Setting Up the Monitor for Home-Use

Set the high and low alarm limits for SpO2 and pulse rate to the values prescribed by the doctor:

High SpO2 alarm limit.

•

Low SpO2 alarm limit.

•

High pulse rate alarm limit.

•

Low pulse rate alarm limit.

•

Clear trend data if necessary. (Press and hold I.D./CLEAR key (J) until P1 is displayed.)

Put the monitor into the home-use mode as follows:

Turn oﬀ the monitor.

Press and hold the ALARM VOLUME key (I ), then press the on/oﬀ key O/I (domestic) L (MDD).

While holding the ALARM VOLUME key (I ),

When

monitor is now in home-use mode.

Verify the monitor is in the home-use mode:

Turn oﬀ the monitor by pressing and holding the I.D./CLEAR key ( J ), then pressing and releasing the

on/oﬀ key O/I (domestic)- L (MDD).

Turn on the monitor while observing the display; k should be shown brieﬂy when the monitor is turned

on. If not, repeat step 3 above.

stops ﬂashing and lights steady (in about 6 seconds), release the ALARM VOLUME key (I ). The

ﬂashes in the pulse rate display.

Clinician’s Operation Manual 8-1

Page 40

Chapter 8: Operating Modes

Verify the high and low alarm limits for SpO2 and pulse rate are set to the values prescribed by the doctor.

5. (Press ALARM SELECT (

Turn oﬀ the monitor by pressing and holding the I.D./CLEAR key (J), then pressing and releasing the on/oﬀ

key O/I (domestic)- L (MDD).

) to show each of the alarm limits one-at-a-time.)

Equipment and Supplies Checklist for Home-Use

Provide the following to the home-use caregiver:

QUANTITY CAT. NO. DESCRIPTION

1 3304 Oximeter

1 1611 Battery Charger 105-125 VAC 60 Hz

1 1612 Battery Charger 208-252 VAC 50/60 Hz

1 1613 Battery Charger 90-110 VAC 60 Hz

* 3049 Adhesive Strips (Adhesive Tape)

1 1861 Home-Use Instruction Book

* Quantity prescribed by doctor.

The doctor will prescribe the type and quantity of the sensors needed for home-use:

QUANTITY CAT. NO. DESCRIPTION

* 3044 Sensor, Reusable, Finger

* 3444

* 3178 Sensor, Pediatric Finger (5-45 kg)

1 3311 Cable, Oximetry, 1.5 m (5 Feet)

* 1300 Sensor, Disposable, Adult

* 1301 Sensor, Disposable, Pediatric

* 1302 Sensor, Disposable, Neonate

* 1303 Sensor, Disposable, Infant

* Quantity prescribed by doctor.

Sensor, Reusable, Comfort Clip

The home-use caregiver will also need these supplies and reference materials:

QUANTITY DESCRIPTION

1 Scissors (for trimming adhesive strips or adhesive tape).

* Isopropyl alcohol and a soft, clean cloth (or alcohol

wipes) for disinfecting monitor and reusable sensor.

1 Written instructions on how to respond to the monitor’s

alarms.

1 Emergency phone numbers for the doctor.

1 Emergency phone number for the hospital emergency

room.

1 Emergency phone number for local paramedics or police.

1 Phone number for equipment supplier in case the

equipment fails.

* Quantity prescribed by doctor.

8-2 Clinician’s Operation Manual

Page 41

Chapter 8: Operating Modes

Training the Home-Use Caregiver

The home-use caregiver must be trained in CPR.

Make sure the monitor’s alarm limits are properly set and that the monitor is in the home-use mode.

Inform the caregiver that the oximeter is not to be used as an apnea monitor.

(Following the Home-Use Instruction Book while teaching these tasks may help you and the caregiver.) Show the home-use caregiver how to:

connect the wall mount power supply to the wall outlet.

•

make sure the wall mount power supply outlet is not controlled by a wall switch.

•

connect the monitor to the wall mount power supply.

•

make sure the monitor’s POWER indicator is lit.

•

visually inspect the sensor and oximetry cable.

•

connect the sensor to the oximetry cable.

•

connect the oximetry cable to the monitor.

•

turn on the monitor.

•

route the cable safely from the patient to the monitor to prevent possible patient strangulation.

•

attach the sensor(s) prescribed by the doctor.

•

measure the SpO2, pulse rate, and pulse strength bar graph readings.

•

change the brightness of the display.

•

change the pulse beep volume.

•

turn oﬀ the alarm and alert tones for two minutes.

•

turn on the alarm and alert tones.

•

interpret the alarms.

•

view the alarm limits.

•

interpret the SENSOR alert.

•

interpret the LO BATT attention.

•

turn oﬀ the monitor.

•

Tell the caregiver how to respond:

in case of a patient emergency, including what therapy to provide the patient.

•

in case an alarm sounds, including what therapy to provide the patient.

•

in case the SENSOR alert sounds.

•

in case the LO BATT attention sounds.

•

in case the caregiver has trouble operating the equipment.

•

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Page 42

Chapter 8: Operating Modes

Turning Oﬀ Home-Use Mode

Turn oﬀ the home-use mode as follows:

Turn oﬀ the monitor.

Press and hold the PULSE VOLUME key (

While holding the PULSE VOLUME key (K), k ﬂashes in the pulse rate display.

When k stops ﬂashing, and patient number pn (n = patient number) lights steady, (in about 6 seconds),

release the key. The monitor is now in clinician mode.

Verify the monitor is in the clinician mode:

Turn oﬀ the monitor.

Turn on the monitor while observing the display; the software revision then the patient number should

be displayed during power-up. If not, repeat step 1 above.

), then press the on/oﬀ key O/I (domestic) L (MDD).

Setting Up the Monitor for Sleep Study Mode

NOTE! When entering or exiting Sleep Study mode previous memory will be lost.

To access the monitors sleep study mode, execute the following steps:

Turn the monitor OFF.

Press and hold the ALARM SEL (

2. enable the monitors setup menu at power up.

Repeatedly press the ALARM SEL (

Press the up or down key (n or o) until

Again press the ALARM SEL (

NOTE! The monitor mode is NOT displayed at power up and can only be observed in the monitors setup

menu. To ensure the correct mode of operation, the setup menu should be checked at power up to verify mode of operation.

) key, then press the ON/OFF key O/I (domestic) L (MDD). This will

) key until

is displayed.

SLP

) key to exit the setup menu and display the current patient number.

(“normal”) is displayed.

nor

Turning Oﬀ Sleep Study Mode

To disable the sleep study mode, and return the monitor to the clinician mode, execute the following steps:

Turn the monitor OFF.

Press and hold the ALARM SEL (

enable the monitor’s setup menu at power up.

Repeatedly press the ALARM SEL (

Press the up or down key (n or o) until

Again press the ALARM SEL (

The monitor is now in clinician mode

) key, then press the ON/OFF key O/I (domestic) L (MDD). This will

) key until

(“normal”) is displayed.

nor

) key to exit the setup menu and display the current patient number.

SLP

is displayed.

8-4 Clinician’s Operation Manual

Page 43

Chapter 9: Charging the Monitor

PRINTER OUTPUT 6 - 8V 0.35A

-----

- - -

ONLY USE BCI AC ADAPTER INPUT 12V 0.35A

-----

- - -

Figure 9.1: Connecting AC Power

Chapter 9: Charging the Monitor

AC Charger to Wall Outlet.

AC Charger to AC Power Connector.

AC Power Connector.

WARNING! Do not allow any moisture to touch the AC power supply connectors or a safety hazard may

result. Ensure that hands are thoroughly dry before handling the AC power supply.

CAUTION! Ensure the device’s AC rating is correct for the AC voltage at your installation site before using

this monitor. The monitor’s AC rating is shown on the external power supply. If the rating is not correct, do not use the monitor. Contact the Smiths Medical PM, Inc. service department, or your local distributor, for help.

Connect the wall mount charger as shown.

•

Connect the AC Charger to the AC Power Connector of the monitor ﬁrst and the AC Charger to the Wall Outlet second.

WARNING! If there is a risk of the AC power supply becoming disconnected from the monitor during use,

secure the cord to the monitor several inches from the connection.

Make sure the POWER indicator lights up on the monitor. If not, see the Troubleshooting section.

The green indicator lights while the monitor’s battery is charging and connected to AC power.

The monitor’s battery will fully charge in about six (6) hours. A fully charged battery provides approximately

4.5 hours of use (new).

WARNING! Disconnect the AC power supply from the outlet before disconnecting it from the monitor.

Leaving the AC power supply connected to an AC power outlet without being connected to the monitor may result in a safety hazard.

CAUTION! The monitor contains a lead-acid. If the battery fails to hold a charge or otherwise becomes

inoperable, the battery should be replaced and the old battery should be disposed of properly. Lead acid batteries should not be disposed of in normal trash containers. They should be sent to the proper facilities so that the metals in them may be reclaimed and/or recycled. Lead Acid Battery: In the US, 1-800-822-8837 will also provide information about the proper disposal of the lead-acid battery. Regulations in Europe vary from country to country. Consult local authorities for information about the proper disposal of the lead acid battery.

Clinician’s Operation Manual 9-1

Page 44

Chapter 9: Charging the Monitor

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9-2 Clinician’s Operation Manual

Page 45

Chapter 10: Maintenance

Schedule of Maintenance

MAINTAIN THIS ITEM HOW OFTEN BY DOING THIS

Battery

Repositioning the sensor. At least once every 4 hours. Follow the instructions for

Disinfecting the reusable sensor. Before attaching the sensor to the

Disinfecting the monitor and the wall mount charger.

When LO BATT (M) indicator is ﬂashing, or after the monitor has been used under battery power.

patient.

When necessary. Disconnect the monitor from the

Follow the instructions for charging the monitor.

attaching the sensor.

Follow the instructions for disinfecting the reusable sensor.

1. wall mount charger.

Disconnect the wall mount

2. charger from the wall outlet and from the monitor.

Wipe the surfaces of the monitor

3. and the wall mount charger with a soft, clean cloth dampened in isopropyl alcohol. Use only a cloth that is dampened, not wet.

CAUTION! Do not allow isopropyl

alcohol to enter any of the openings on the monitor. Evidence that liquid has been allowed to enter the monitor voids the warranty.

Correcting the SENSOR Alert

Follow these steps to correct the sensor alert:

Make sure the sensor’s connector is ﬁrmly seated in the monitor’s connector.

Make sure the sensor is properly attached to the patient. See Attaching the Sensor to the Patient section for

2. help.

Make sure the adhesive tape used to hold the sensor is not wrapped too tightly. Wrapping the tape too

3. tightly may prevent the monitor from measuring the SpO2 and pulse rate.

If the sensor alert is still on, contact your doctor or the equipment dealer for help.

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Page 46

Chapter 10: Maintenance

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10-2 Clinician’s Operation Manual

Page 47

Chapter 11: Troubleshooting

PROBLEM POSSIBLE CAUSE SOLUTION

SENSOR alert. Sensor may not be properly

connected to monitor.

Sensor may not be properly attached to patient.

Adhesive tape may be too tight on patient.

Sensor interface cable, or monitor may be defective.

LO BATT (M)

attention.

SpO2, pulse rate, or pulse bar graph not shown on monitor. or Pulse rate value erratic, intermittent, or incorrect. or SpO2 value erratic, intermittent, or incorrect.

Monitor does not turn

on when O/I ( L ) key

is pressed.

Monitor turns oﬀ suddenly.

POWER indicator does not light when AC power supply is attached

No printout on optional printer.

Monitor’s battery has become weak from use.

Patient may be moving. Have patient remain as still as possible.

Connectors from sensor to monitor may not be ﬁrmly seated.

Sensor may not be properly attached to patient.

Adhesive tape may be too tight on patient.

Sensor, interface cable, or monitor may be defective.

Battery needs charging. See Charging the Monitor.

Monitor may be defective. Contact authorized repair center for help.

Battery needs charging. See Charging the Monitor.

AC Power supply or monitor may be defective.

Printer power not connected, or printer power switch is oﬀ.

Printer interface connectors not ﬁrmly seated.

Printer or monitor may be defective. Contact authorized repair center for help.

Chapter 11: Troubleshooting

Make sure sensor connector is ﬁrmly seated in monitor connector.

See Attaching the Sensor to the Patient.

Loosen adhesive tape.

Contact authorized repair center for help.

See Charging the Monitor.

Make sure all connectors between sensor and monitor are ﬁrmly seated.

See Attaching the Sensor to the Patient.

Loosen adhesive tape.

Contact authorized repair center for help.

Make sure the AC power supply is ﬁrmly connected to the wall outlet and to the monitor.

Make sure the wall outlet is not controlled by a switch.

Make sure AC power supply is available at the wall outlet. (Plug a lamp or a radio into the same wall outlet and see if the lamp or radio turns on.)

Contact authorized repair center for help.

Make sure the power is connected to the printer and the printer power switch is on.

Make sure printer interface cables are ﬁrmly seated.

Insure that the proper communication protocol has been selected for the printer.

Clinician’s Operation Manual 11-1

Page 48

Chapter 11: Troubleshooting

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11-2 Clinician’s Operation Manual

Page 49

Chapter 12: Optional Supplies & Accessories

CAT. NO. DESCRIPTION QTY.

1300 Sensor, Oximetry, Disp., Adult Finger 10/box

1301 Sensor, Oximetry, Disp., Ped. Finger, 15-45 kg 10/box

1302 Sensor, Oximetry, Disp., Neonate, < 3 kg 10/box

1303 Sensor, Oximetry, Disp., Infant, 3-15 kg 10/box

1606 Simulator, Oximeter each

1611 Battery Charger 105-125 VAC 60 Hz each

1612 Battery Charger 208-252 VAC 50/60 Hz each

1613 Battery Charger 90-110 VAC 60 Hz each

1857 Manual, Clinician’s Operation (3304) each

1858 Manual, Service (3304) each

1861 Manual, Home Use Instruction Book (3304) each

3025 Sensor, Oximetry, Wrap, Infant, 3-15 kg each

3026 Sensor, Oximetry, Wrap, Neonate, < 3 kg each

3043 Sensor, Oximetry, Universal ‘Y’ each

3044 Sensor, Oximetry, Finger each

3049 Strips, Adhesive 40/pkg.

3078 Sensor, Oximetry, Ear each

3134 Tape, Attachment, Neonatal 50/pkg.

3135 Tape, Attachment, Infant 50/pkg.

3136 Tape, Attachment, Neonatal 100/pkg.

3137 Tape, Attachment, Infant 100/pkg.

3138 Posey Wrap, Attachment, Universal ‘Y’ 10/pkg.

3178 Sensor, Pediatric Finger, 5-45 kg each

3311 Cable, Oximetry, 1.5 m (5 feet) each

3351 Adapter, Analog Output each

3352NO Adapter, Digital Output (Nurse Call – open circuit) each

3352NC Adapter, Digital Output (Nurse Call – closed circuit) each

3361 Cable, Printer Interface each

3362 Cable, PC Interface each

3444

Sensor, Oximetry, Finger, Comfort Clip

each

Ordering Information

Outside the USA, for ordering information, contact your local distributor. In the USA, for ordering information, contact the customer service department at the address or phone number below:

Smiths Medical PM, Inc.

N7W22025 Johnson Drive

Waukesha, WI 53186

E-mail address: info.pm@smiths-medical.com

Clinician’s Operation Manual 12-1

Phone: (262) 542-3100

Toll-Free: (800) 558-2345

Fax: (262) 542-0718

Page 50

Chapter 12: Optional Supplies & Accessories

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12-2 Clinician’s Operation Manual

Page 51

Chapter 13: Speciﬁcations

Parameters Monitored

SpO2, Pulse Rate, and Pulse Strength

Displays, Indicators, & Keys

Chapter 13: Speciﬁcations

SpO2:

Display update rate: 1Hz

Pulse Rate: 3-digit LED display, 0.43 inches (10.9 mm) high.

Display update rate: 1Hz

Pulse Strength: Logarithmically scaled 8-segment LED bar graph.

Display update rate: 60Hz

SENSOR: Sensor alert indicator.

LO BATT (M ):

SILENCE (

ALARM (

ARTIFACT (z ):

SEARCH: Indicates that the monitor is looking for a pulse.

Keys: Eight control keys provided.

Brightness:

Power: Indicates oximeter connected to AC power.

SpO

3-digit LED display, 0.43 inches (10.9 mm) high.

Low battery indicator.

Alarm and alert tone silenced indicator.

Alarm indicator.

Indicates the presence of motion artifact.

Adjustable brightness of SpO2, pulse rate, and bar graph displays.

Range: 0-100%

Accuracy1:

Alarm Limits: High 100-50% and oﬀ in 1% steps.

Averaging: 4, 8, or 16 pulse beat average.

Because pulse oximeter measurements are statistically distributed, only about two-thirds of pulse oximeter equipment measurements can be expected to fall within the A The 3304 has been validated on 10 adult volunteers that did not have health problems and were non-smokers. The study was conducted at oxygen concentrations evenly distributed over an SaO2 range of 50-100%

±2% at 70-100% ±3% at 50-69%

Low 50-99% and oﬀ in 1% steps.

of the value measured by the CO-oximeter.

RMS

Sensors

Red: 660nm, 2mW (typical)

Infrared: 905nm, 2-2.4mW (typical)

Clinician’s Operation Manual 13-1

Page 52

Chapter 13: Speciﬁcations

Pulse Rate

Range: 30-254 BPM

Accuracy: ±2% at 30-254 BPM

Alarm Limits: High 250-5 BPM and oﬀ in 1 BPM steps.

Low 5-250 BPM and oﬀ in 1 BPM steps.

Pulse Tone:

Averaging: 8 or 16 second average.

Pitch corresponds to SpO2. Volume adjustable to oﬀ.

Alarm Indicators

User-adjustable volume from 45dBA to 85dBA and two-minute or indeﬁnite alarm silence. Audible alarm consists of 2 bursts of 5 beeps repeated every 20 seconds. Corresponding numeric display ﬂashes.

Sensor Alert Indicator

Same volume and silence as alarm tone. Audible alarm consists of a pair of beeps repeated every 10 seconds.

Printer Output

SpO2 and pulse rate can be printed every ﬁve (5) seconds (data log). Data saved every four (4) to thirty (30) seconds can be printed (trend).

Battery

Type: Internal rechargeable lead acid; not user replaceable.

Charge Time: Fully charges in about 6 hours.

Use Time: Approximately 4.5 hours continuous use (new).

Indicators:

LO BATT(M ) indicator lights when about 30 minutes of battery use remains.

AC Charger

Wall Mount Style: Input of 105-125 VAC 60Hz

Input of 90-110 VAC 60Hz (Optional)

Table Top Style: Input of 208-252 VAC 50/60Hz

Dimensions

Width: 216 mm (8.5 inches)

Height: 82 mm (3.24 inches)

Depth: 140 mm (5.5 inches)

Weight: 850 grams (30 ounces) including battery

Environmental Speciﬁcations

Temperature: Operating: 0 to 40° C (32 to 104° F)

Storage: -40 to +75° C (-40 to +167° F)

Relative Humidity: Operating: 15 to 95%, non-condensing

Storage: 10 to 95%

13-2 Clinician’s Operation Manual

Page 53

Appendix A: Outputs

Analog Outputs

Attach the Analog Output Printer Adapter (Cat #3351) to the printer/PC connector located on the back of the

1. monitor.

Enter the setup mode by pressing and holding the ALARM SELECT key (

Press the ALARM SELECT key (

Use the up arrow (n) to select the “A (analog)” mode.

The analog output is equal to 10 mV times the measurement on the display (5 volts full-scale).

MEASUREMENT FULL SCALE

SpO

Rate 0-1 Volt

In order to provide zero and full-span reference voltages for the user, the 3304 will generate:

1 VDC if sensor is not plugged into the unit

•

0 VDC if sensor is plugged into the unit, but no ﬁnger in the sensor (“dashes” on the screen).

•

Gain and oﬀset calibration procedure:

Plug the sensor in but do not put your ﬁnger into the sensor.

Adjust the oﬀset setting of the chart recorder to display 0% SpO2 and 0 bpm Pulse Rate.

Unplug the sensor.

0-1 Volt

) one more time to get the “

OUT P

) at power-up.

” message.

Adjust the gain setting of the chart recorder to display 100% SpO2 and 250 bpm Pulse Rate.

ANALOG OUTPUTS

Conﬁguration Optional, attached and powered by

communication port

Channels

Resolution

Clinician’s Operation Manual A-1

Two, Pulse Rate and SpO SpO2: 0-100% = 0-1.00 VDC Rate: 30-250 bpm = 0.12-1.00 VDC

SpO2: 9.7mV per count Rate: 3.9 mV per count

Page 54

Appendix A: Outputs

Digital Outputs

WARNING! Verify the functionality of any remote alarm system connected to this monitor before leaving

the patient unattended.

Attach the Digital Alarm Output Printer Adapter (Cat #3352NO or #3352NC) to the printer/PC connector

1. located on the back of the monitor

Enter the setup mode by pressing and holding the ALARM SELECT key (

Press the ALARM SELECT key (

Use the up arrow (n) to select the “D “ (digital) mode.

When enabled, the digital outputs for any audible alarm will activate. An audible alarm is considered any alarm that will sound provided it is not silenced. These alarms include high or low SpO2, Lost Pulse, sensor is oﬀ the ﬁnger (not receiving a valid pulse), and low battery.

) one more time to get the “

OUT P

) at power-up.

” message.

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Page 55

Appendix B: Guidance and Manufacturer’s Declaration

Guidance and Manufacturer’s Declaration

The 3304 pulse oximeter is intended for use in the electromagnetic environment speciﬁed in the tables within this appendix.

NOTE! The customer or user of the 3304 pulse oximeter should ensure that it is used in such an

environment.

Electromagnetic Emissions - Emissions Test

EMISSIONS TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT GUIDANCE

RF emissions CISPR 11

Harmonic emissions IEC 61000-3-2

Voltage ﬂuctuations/ ﬂicker emissions IEC 61000-3-3

Group 1 The 3304 pulse oximeter 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 B The 3304 pulse oximeter is suitable for use in all establishments,

including:

Domestic establishments.

• Establishments directly connected to the public low-voltage

• power supply network that supplies buildings used for domestic purposes.

Electromagnetic Emissions – Immunity

IMMUNITY

Electrostatic discharge (ESD) IEC 61000-4-2

IEC 60601 TEST LEVEL

± 6 kV contact

• ± 8 kV air

•

COMPLIANCE LEVEL

± 6 kV contact

• ± 8 kV air

•

ELECTROMAGNETIC ENVIRONMENT

GUIDANCE

Floors should be made of:

Wood

• Concrete

• Ceramic Tile

•

If ﬂoors are covered with synthetic material, the relative humidity should be at least 30%.

Clinician’s Operation Manual B-1

Page 56

Appendix B: Guidance and Manufacturer’s Declaration

IMMUNITY ELECTROMAGNETIC ENVIRONMENT

Electrical fast transient/burst IEC 61000-4-4

IEC 60601 TEST LEVEL

±0.5 kV to ±2 kV for power

• supply lines.

±0.25kV to ±1kV for input/

• output lines.

COMPLIANCE LEVEL

±0.5 kV to ±2 kV for power

• supply lines.

±0.25kV to ±1kV for input/

• output lines.

Surge IEC 61000-4-5

IEC 60601 TEST LEVEL

±1 kV diﬀerential mode

• ±2 kV common mode

•

COMPLIANCE LEVEL

±1 kV diﬀerential mode

• ±2 kV common mode

•

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

IEC 60601 TEST LEVEL

<5% UT (>95% dip in UT) for

•

0.5 cycle. <40% UT (>60% dip in UT) for

• 5 cycles.

<70% UT (>30% dip in UT) for

• 25 cycles.

<5% UT (>95% dip in UT) for 5

• seconds.

COMPLIANCE LEVEL

GUIDANCE

A.C. Mains power voltage should be the typical quality of a:

Commercial environment.

•

Hospital environment.

•

<5% UT (>95% dip in UT) for

•

0.5 cycle. <40% UT (>60% dip in UT) for

• 5 cycles.

<70% UT (>30% dip in UT) for

• 25 cycles.

<5% UT (>95% dip in UT) for 5

• seconds.

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

B-2 Clinician’s Operation Manual

Page 57

IMMUNITY ELECTROMAGNETIC ENVIRONMENT

Power frequency (50/60 Hz) IEC 61000-4-8

IEC 60601 TEST LEVEL

3 A/m

COMPLIANCE LEVEL

3 A/m

Conducted RF IEC 61000-4-6

IEC 60601 TEST LEVEL

3 V rms

• 150 kHz to 80MHz

•

COMPLIANCE LEVEL

3 Vrms 80% AM modulation @

• 1kHz

150 kHz to 80 MHz

•

Radiated RF IEC 61000-4-3

IEC 60601 TEST LEVEL

3 V/m

• 80 MHz to 2.5 GHz

•

COMPLIANCE LEVEL

3 V/m 80% AM

• 80 MHz to 1.0 GHz

•

P = Manufacturer’s output power in watts (W).

• d = Recommended distance in meters (m).

•

Appendix B: Guidance and Manufacturer’s Declaration

GUIDANCE

Power frequency magnetic ﬁelds should be the typical levels of a:

Commercial environment

• Hospital environment

•

Recommended separation distance:

d = 1.2

Recommended separation distance:

d = 1.2 √P 80 MHz to 800 Mhz

d = 2.3 √P 800 MHz to 2.5 GHz

Field strengths from ﬁxed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in each frequency range.

CAUTION! 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.

Field strengths from ﬁxed RF 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 3304 pulse oximeter is used exceeds the applicable RF transmitter compliance level above, the 3304 pulse oximeter should be observed to verify normal operation. If abnormal

performance is observed, additional measures may be necessary, such as reorienting or relocating the 3304 pulse oximeter.

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

Clinician’s Operation Manual B-3

Page 58

Appendix B: Guidance and Manufacturer’s Declaration

Recommended Separation Distances

The 3304 pulse oximeter is intended for use in an electromagnetic environment where radiated RF disturbances are controlled. The customer or the user of the 3304 pulse oximeter can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 3304 pulse oximeter as recommended below, according to the maximum output power of the communications equipment.

The recommended separation distances between portable and mobile RF communication equipment and the 3304 pulse oximeter is:

SEPARATION DISTANCE ACCORDING TO THE

RATED MAXIMUM OUTPUT POWER

OF RF TRANSMITTER WATTS

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

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.

150 kHz to 80MHz

FREQUENCY OF RF TRANSMITTER METERS

80 MHz to 800 MHz

d = 1.2 √P

800 MHz to 2.5 GHz

d = 2.3 √P

NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is aﬀected by absorption

and reﬂection from structures, objects and people.

WARNING! The monitor should not be used adjacent to or stacked with other equipment. If adjacent or

stacked use is necessary, the monitor should be observed to verify normal operation in the conﬁguration in which it will be used.

B-4 Clinician’s Operation Manual

Page 59

Appendix C: Revision History

REVISION DATE COMMENT

Rev. 12 2008-02 Added new BCI and Smiths Medical logos to front cover.

•

Updated ON/OFF key for the domestic monitor keypad.

•

Added Australian Representative to Warranty and Service section

• and back cover.

Updated symbol chart.

•

Added WEEE Recycling instructions to symbol chart.

•

Updated warnings, cautions and notes.

•

Added warning about incorrectly applied sensors giving inaccurate

• readings.

Changed “co-oximeter” to “CO-oximeter” in desat study info in SpO2

• specs.

Fixed sentence on page B-3 about ﬁeld strengths from ﬁxed RF

• transmitters.

Deleted Smiths Medical logo from back cover.

•

REVISION DATE COMMENT

Rev. 11 2007-05 Changed company logo and added manufacturer’s address to back

• cover.

Added warning to verify that all LEDs light up upon startup of the

• device.

Added note about alarm limits being retained during power cycles.

•

Added warning to be aware of alarm limits of similar monitors in the

• area.

Added desat study information to SpO2 speciﬁcations section in

• Chapter 13.

Added information about alarm volume to Alarm indicators in

• Chapter 13.

Added Appendix B: Guidance and Manufacturer’s Declaration.

•

Moved Revision History from Appendix B to Appendix C.

•

Clinician’s Operation Manual C-1

Page 60

Appendix C: Revision History

REVISION DATE COMMENT

Rev. 10 2007-01 Added warnings about AC power.

REVISION DATE COMMENT

Rev. 9 2006-06-01 Added this Revision History

•

Added caution about cleaning agents causing brittleness.

•

Added warning about the monitor displaying dashes or erroneous

• values in certain conditions.

Changed numerous cautions and notes to warnings.

•

Added warning to check for correct AC voltage to Chapter 9.

•

Updated trademark information.

•

Updated Proprietary Notice in Warranty section.

•

Removed hyphen from Comfort Clip.

•

Updated e-mail address.

•

Updated Revision History.

•

Converted font to Myraid Pro

•

Updated format

•

Added registered trademark information to Table of Contents.

•

Added Patent information to Table of Contents

•

Added Rx Only symbol, WEEE symbol, and Do Not Reuse symbol to

• chart in Chapter 1.

Added photodynamic therapy warning and dropped or damaged

• warning.

Added accuracy veriﬁcation caution, damage to front panel keys

• caution, and operator’s responsibility to set alarm limits caution.

Added dysfunctional hemoglobins note.

•

Added IFU Note to Chapter 2.

•

Removed 1310 and 1311 everywhere in manual.

•

Updated parts list in Chapter 13.

•

Updated Line Art.

•

C-2 Clinician’s Operation Manual

Page 61

Page 62

@ Authorized European Representative (as deﬁned by the Medical Device Directive):

Smiths Medical International, Ltd. Colonial Way, Watford, Herts, WD24 4LG, UK

Australian Representative:

Smiths Medical Australasia Pty. Ltd. 61 Brandl Street, Eight Mile Plains, QLD 4113, Australia

Phone: (44) 1923 246434

Fax: (44) 1923 240273

Tel: +61 (0) 7 3340 1300

Manufactured By

Smiths Medical PM, Inc.

N7W22025 Johnson Drive

Waukesha WI, 53186

BCI BCI 3304 Oximeter Operators Manual Oximeter Clinician's Operation Manual Catalog Number: 1857E

Specifications and Main Features

Frequently Asked Questions

User Manual