3401 Oximeter Operation Manual Ver 1 April 2002

Table of Contents

Clinician’s Operation Manual Warranty & Service Information ... iii Proprietary Notice ... iii Limited Warranty ... iii Service Support ... iii CE Notice... iii

Warnings, Cautions, & Notes

iv

Symbol Definitions ... iv Warnings ... iv Cautions ...v Notes ...v

Chapter 1: Introduction

1-1

About the Manual... 1-1 Theory of Operation... 1-1

Chapter 2: Intended Use and Monitor Features

2-1

Intended Use ... 2-1 Monitor Features ... 2-1

Chapter 3: Controls & Features

3-1

Monitor Front Panel ... 3-1 Sensor/Serial Connector... 3-1 SpO2 Numeric Display ... 3-1 Pulse Rate Numeric Display... 3-1 Pulse Strength Bar Graph... 3-1 Low Battery Indicator ... 3-1 x ON OFF Key... 3-2 F PRINT Key ... 3-2

Chapter 4: Operating Instructions

4-1

Unpacking the Monitor ... 4-1 Installing the Batteries... 4-1 Attaching the Sensor to the Patient ... 4-2 Choosing the Sensor... 4-2 Care and Handling of the Sensor... 4-3 Checking the Sensor and Oximetry Cable ... 4-4 Cleaning or Disinfecting the Sensors ... 4-4 Turning On the Monitor... 4-5 Low Battery Indicator ... 4-6 Turning Off the Monitor ... 4-6 Checking the Monitor’s Performance ... 4-6 Operating Modes... 4-6 Verification Mode ... 4-7 Data Collection Mode ... 4-7 Trend Printing Mode... 4-8

Chapter 5: Instructions for Training the Home User

5-1

Equipment and Supplies Checklist for Home Use ... 5-1 Training the Home User... 5-1

Chapter 6: Trend Data

6-1

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

Pulse Oximeter for Sleep Screening Operation Manual

i

Table of Contents

Chapter 7: Printer

7-1

Description... 7-1 Trend Summary Printout ... 7-1 What You’ll Need for Printing ... 7-3 Trend Printouts ... 7-4 Collecting Trend Data... 7-4 Paper Feed... 7-4

Chapter 8: PC Communication Setup

8-1

Description... 8-1 PC Communication Setup... 8-1

Chapter 9: Maintenance

9-1

Schedule of Maintenance... 9-1 Storage ... 9-1

Chapter 10: Troubleshooting

10-1

EMI Interference... 10-2

Chapter 11: Optional Supplies & Accessories

11-1

Ordering Information:... 11-1

Chapter 12: Specifications

12-1

Equipment Classification ... 12-1 Displays, Indicators, & Keys ... 12-1 SpO2 ... 12-1 Pulse Rate ... 12-2 Printer ... 12-2 Power Requirements ... 12-2 Battery Life ... 12-2 Dimensions ... 12-2 Environmental Specifications ... 12-2

Appendix A: Data Format

Appendix-1

Data format. ...Appendix-1

Appendix B: Setting the Optional Real Time Clock

ii

Appendix-2

Pulse Oximeter for Sleep Screening Operations Manual

Warranty & Service Information

Warranty & Service Information Proprietary Notice Information contained in this document is copyrighted by BCI, Inc. and may not be duplicated in full or part by any person without prior written approval of BCI, 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. Every effort has been made to keep the information contained in this document current and accurate as of the date of publication or revision. However, no guarantee is given or implied that the document is error free or that it is accurate regarding any specification. Limited Warranty BCI, Inc. warrants each new device to be free from defects in workmanship and materials under normal use and service for a period of two (2) years from the date of shipment. The sole obligation of BCI, Inc. under this warranty will be to repair or replace, at its option, products that prove to be defective during the warranty period. The foregoing shall be the sole warranty remedy. Except as set forth herein, seller makes no warranties, either expressed or implied, including the implied warranties of merchantability and fitness for a particular purpose. No warranty is provided if the products are modified without the express written consent of BCI, Inc., and seller shall not be liable in any event for incidental or consequential damage. This warranty is not assignable. Service Support Repairs for devices manufactured by BCI, Inc. under warranty must be made at authorized repair centers. If the device needs repair, contact your local distributor or the BCI, Inc. service department. When calling, have the device’s model and serial number ready. If you need to ship the device, pack the device and accessories carefully to prevent shipping damage. All accessories should accompany the device. BCI, Inc. Phone: (262) 542-3100 N7 W22025 Johnson Road Fax: (262) 542-3325 Waukesha, WI USA 53186-1856 Toll Free; (800) 558-2345 email : [email protected]

CE Notice Marking by the symbol C0473 indicates compliance of this device to the Medical Device Directive 93/42/EEC. Authorized Representative (as defined by the Medical Device Directive): Graseby Medical Ltd. Colonial Way, Watford, Herts, UK WD2 4LG

Pulse Oximeter for Sleep Screening Operation Manual

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

iii

Warnings, Cautions, & Notes

Warnings, Cautions, & Notes KEYWORD

DEFINITION

WARNING

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

CAUTION

Tells you something that could damage the monitor

NOTE

Tells you other important information

Symbol Definitions SYMBOL

DEFINITION

r 2 1

Type BF equipment

SN

Serial Number

REF

Catalog Number

F y 2 x 1 l C

Printer On/Off

IPX1

Drip Proof

Attention, consult accompanying documents Refer servicing to qualified service personnel

Date of Manufacturing Do not reuse On/Off Non AP device Lot Number Use By

Warnings WARNING! Federal law (USA) restricts the use or sale of this device by, or on the order of a physician. 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! This device must be used in conjunction with clinical signs and symptoms. This device is only intended to be an adjunct in patient assessment. WARNING! Prolonged use or the patient’s condition may require changing the sensor site periodically. Patients setting up the device at home should be instructed of the signs/symptoms of sensor misuse (e.g., pressure sores from prolonged application) and should be advised to move the sensor to another finger if necessary. 1

WARNING! When attaching sensors with Microfoam® tape, do not stretch the tape or attach the tape too tightly. Any device (tape, Velcro™) applied too tightly may cause inaccurate readings and blisters on the patient’s skin (lack of skin respiration, not heat, causes the blisters).

1

iv

Microfoam® is a registered trademark of the 3M Company

Pulse Oximeter for Sleep Screening Operation Manual

Warnings, Cautions, & Notes

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 the signal output port configures a medical system, and, therefore, is responsible that the system complies with the requirements of the system standard IEC 601-1-1. 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. PATIENT ENVIRONMENT

.9

5m

R

(4

ft)

1.

Cautions CAUTION! Do not autoclave, ethylene oxide sterilize, or immerse the sensors in liquid. Evidence that liquid has been allowed to enter the monitor voids the warranty. CAUTION! This device is intended for use by persons trained in professional health care or those who have access to the oversight of a professional health care provider. The operator must be thoroughly familiar with the information in this manual and/or the “Home User’s Guide” before using the device. CAUTION! Connect only the PC cable specifically intended for use with this device (see Optional Supplies and Accessories). CAUTION! When printing, or advancing the paper, place the oximeter on its’ side to prevent paper jams.

Notes NOTE! Operation of this device may be adversely affected in the presence of strong electromagnetic sources, such as electrosurgery equipment. NOTE! Operation of this device may be adversely affected in the presence of computed tomograph (CT) equipment. NOTE! Use only SpO2 sensors supplied with, or specifically intended for use with, this device. NOTE! SpO2 measurements may be adversely affected in the presence of high ambient light. Shield the sensor area (with a towel, for example) if necessary.

Pulse Oximeter for Sleep Screening Operation Manual

v

Warnings, Cautions, & Notes

NOTE! Dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, patent blue V (PBV), and fluorescein, may adversely affect the accuracy of the SpO2 reading. NOTE! 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. NOTE! Remove fingernail polish or false fingernails before applying SpO2 sensors. Fingernail polish or false fingernails may cause inaccurate SpO2 readings. NOTE! Batteries are designed to be replaceable by individuals trained in this procedure. Follow local governing ordinances and recycling instructions regarding disposal or recycling of device components, including batteries. 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! Hazards arising from software errors have been minimized. Hazard analysis was performed to meet EN60601-1-4:2000. NOTE! 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. NOTE! All user and patient accessible materials are non-toxic.

vi

Pulse Oximeter for Sleep Screening Operation Manual

Chapter 1: Introduction

Chapter 1: Introduction About the Manual The Operation Manual provides installation, operation, and maintenance instructions for health-care professionals and other users, trained in monitoring respiratory and cardiovascular activity.

Theory of Operation The 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. 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 1.0: Theory of Operation

1.

Red and infrared LED light sources

2.

Detector

The oximeter 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 pulse rate and calculate oxygen saturation. Oxygen saturation calculations can be performed because oxygen saturated blood predictably absorbs less red light than oxygen depleted blood. 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 pulse and SpO2 readings.

Pulse Oximeter for Sleep Screening Operation Manual

1-1

Chapter 2: Intended Use & Monitor Features

Chapter 2: Intended Use and Monitor Features Intended Use This device is a handheld pulse oximeter that measures SpO2, pulse rate, and pulse strength. It may be used as a spot check device in the hospital or clinical environments. Additionally, it may be used to collect long term data in overnight sleep screening studies in the sleep lab or home. The oximeter will provide reliable measurements on patients ranging from neonate to adults for spot checking applications and from pediatric to adult for sleep screening applications when using the appropriate catalog accessories. The oximeter will operate accurately over an ambient temperature range of 32 to 131°F (0 to 55°C). This device is not intended for continuous patient monitoring, but can be used for spot checking and/or long-term data collection applications. There are no audible or visible patient alarms.

Monitor Features •

Provides fast, reliable SpO2, pulse rate, and pulse strength measurements on any patient, from neonates to adults for spot-checking applications and on pediatric to adults for sleep screening applications.

•

Ideally suited for use in overnight sleep screening applications allowing printing of summated data results.

•

Three modes of operation: Verification Mode for spot checking, Data Collection Mode for long term data collection in sleep screening environments and Trend Printing Mode for outputting summarized trend data to the built-in printer or to a PC.

•

Device automatically enters Data Collection Mode after 10 minutes of continuous use.

•

Minimal LED display during Data Collection Mode lengthens battery life (I.e. – display is reduced to a single flashing bar).

•

Portable and lightweight. Weighs only 13 ounces (369 grams)., with batteries.

•

Ergonomically designed to fit comfortably in the palm of your hand.

•

Uses four (4) standard “AA” (type IEC LR6) alkaline cells.

•

Battery life (Alkaline Cells): -

2 sleep screening cycles (1 cycle = 10 minutes with display on, 8 hours with display off, 5 minutes printing) or

-

Intermittent monitoring: 1 min on, 2 min off (= 1 cycle) 80 hours or 1600 cycles

•

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

•

An eight-segment LED bar graph indicates pulse strength in the Verification Mode.

•

Low Battery Indicator flashes when about 30 minutes of battery use remains.

•

Capable of 12 hours of data storage.

Pulse Oximeter for Sleep Screening Operation Manual

2-1

Chapter 3: Controls & Features

Chapter 3: Controls & Features Monitor Front Panel Figure 3.1: Monitor Front Panel

1. Sensor/Serial Connector The sensor connects here, or an oximetry cable can be connected between the monitor and the sensor. The serial printer or PC communication cable is also connected here. 2. SpO2 Numeric Display A number shows the patient’s SpO2 value in percent. Dashes (--) mean the monitor is not able to calculate the SpO2 value in Verification Mode. SpO2 display in Data Collection Mode will be one flashing bar to conserve battery life. 3. Pulse Rate Numeric Display A number shows the patient’s pulse rate value in beats per minute. Dashes (---) mean the monitor is not able to calculate the pulse rate value in Verification Mode. In Data Collection Mode, the Heart Rate display will be blank to conserve battery life. 4. Pulse Strength Bar Graph In Verification Mode, the pulse strength bar graph “pulses” with the patient’s pulse beat. The height of the bar graph shows the patient’s pulse strength. 5. Low Battery Indicator A Low Battery Indicator will be indicated by the top bar graph LED quickly flashing about once every second.

Pulse Oximeter for Sleep Screening Operation Manual

3-1

Chapter 3: Controls & Features

Figure 3.2: Monitor Operating Keys

6. x ON OFF Key Pressing this key turns the monitor ON and OFF. 7. F PRINT Key See Chapter 4 for more details on the three modes. Verification Mode: In this mode, momentarily pressing the F key will not activate the printer as the printer function is suppressed in this mode. Pressing and holding the F key in the Verification Mode will advance the paper. Reloading the paper is allowed in this mode. Pressing and holding the F key at power up will erase trends, even if the trend memory is clear. Data Collection Mode: In this mode, momentarily pressing the F key will not activate the printer as the printer function is suppressed in this mode. However, in the Data Collection Mode, pressing and holding this key will advance the paper in the printer. Reloading the paper is allowed in this mode. Trend Printing Mode: Momentarily pressing the F key will activate a printout (statistical sleep screening information). Pressing the F key during the printout will terminate the printout. Pressing and holding the F key will advance the paper. Holding the F key for 6 to 8 seconds at power up will clear the trend and switch the unit into Verification Mode. Reloading the paper is allowed in this mode. NOTE! All data will be irretrievably lost when the trend data is cleared.

3-2

Pulse Oximeter for Sleep Screening Operation Manual

Chapter 4: Operating Instructions

Chapter 4: Operating Instructions This device must be used in conjunction with clinical signs and 2 WARNING: symptoms. This device is only intended to be an adjunct in patient assessment.

Unpacking the Monitor 1.

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

2.

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

Installing the Batteries The oximeter uses 4 standard “AA” alkaline cells, IEC Type LR6. To install/replace the batteries: 1.

Depress the battery door tab and lift up.

2.

Install the negative end of each battery first, compressing the battery terminal spring until the positive terminal clears the positive tab. Press the battery down into place.

3.

Place battery door tabs into the slots of the monitor back panel, depress the door tab and press the door into place.

NOTE: If you install disposable batteries, be sure to dispose of them in compliance with your institution’s guidelines and local ordinances. NOTE: The unit will hold data for about one and a half minutes with no battery power. This allows for battery replacement without loss of stored data. Figure 4.0: Installing the Batteries.

Pulse Oximeter for Sleep Screening Operation Manual

4-1

Chapter 4: Operating instructions

Attaching the Sensor to the Patient What you need to know about attaching the sensor to the patient: Prolonged use or the patient’s condition may require changing the 2 WARNING! sensor site periodically. Patients setting up the device at home should be instructed of the signs/symptoms of sensor misuse (e.g., pressure sores from prolonged application) and should be advised to move the sensor to another finger if necessary. When attaching sensors with Microfoam® tape, do not stretch the tape 2 WARNING! or attach the tape too tightly. A sensor applied too tightly by any method (tape, Velcro™) may cause inaccurate readings and blisters on the patient’s skin (lack of skin respiration, not heat, causes the blisters).

Attaching the patient to the monitor requires these steps: 1.

Choose the sensor.

2.

Check the sensor and oximetry cable.

3.

Clean or disinfect the sensor if using the reusable type. (Disposable sensors are for singlepatient use and do not require cleaning or disinfecting.)

4.

Attach the sensor to the patient.

Choosing the Sensor Choose the appropriate sensor from the following chart. PATIENT Adult > 45 Kg

SITE Finger

DESCRIPTION 3044: Sensor, Adult (reusable) 3444, Comfort Clip™ Finger Sensor (reusable)

Finger or Toe

3043: Sensor, Universal “Y” (reusable) 1300: Sensor, Disposable, Adult Finger 1310: D.O.T Sensor 1311: D.O.T Sensor

Pediatric 15-45 Kg

Ear

3078: Sensor, Ear (reusable)

Finger

3044: Sensor, Adult (reusable) 3444, Comfort Clip™ Finger Sensor (reusable)

Finger or Toe

3043: Sensor, Universal “Y” (reusable) 1301: Sensor, Disposable, Ped. Finger

4-2

Ear

3078: Sensor, Ear (reusable)

Infant 3-15 Kg (for spot-check only)

Hand or Foot

3043: Sensor, Universal “Y” (reusable)

Toe

3025: Sensor, Wrap, Infant (reusable)

Finger or Toe

1303: Sensor, Disposable, Infant

Neonate < 3 Kg (for spot-check only)

Hand or Foot

1302: Sensor, Disposable, Neonate

Foot

3026: Sensor, Wrap, Neonate (reusable)

Pulse Oximeter for Sleep Screening Operation Manual

Chapter 4: Operating Instructions

Care and Handling of the Sensor Misuse or improper handling of the sensor and cable could result in 2 WARNING! damage to the sensor. This may cause inaccurate readings.

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

1.

Connector

2.

Cable

Do not use excessive force or unnecessary twisting when connecting, disconnecting, storing, or using the sensor. When placing the sensor on the patient, allow the cable to lay across the palm 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.

Upon completion of patient monitoring, detach the sensor as shown in Figure 4.1 and loosely coil the finger sensor cable. Pulse Oximeter for Sleep Screening Operation Manual

4-3

Chapter 4: Operating instructions

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 is working properly. Using a damaged sensor may cause inaccurate readings. Inspect each 2 WARNING! sensor. If a sensor appears damaged, do not use it. Use another sensor or contact your authorized repair center for help. Using a damaged oximetry cable may cause inaccurate readings. 2 WARNING! Inspect the oximetry cable. If the oximetry cable appears damaged, do not use it. Contact your authorized repair center for help.

1.

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

2.

If using the oximetry cable: a.

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

b.

If the sensor is not already connected to the oximetry cable, connect the sensor to the oximetry cable. Carefully align and push the connectors together firmly and close the latch to secure the connectors.

c.

If the oximetry cable is not already connected to the monitor, connect the oximetry cable to the monitor. Carefully align and push the connector firmly into the monitor.

3.

If not using the oximetry cable, connect the sensor to the monitor. Push the connector firmly into the monitor.

4.

If the monitor is not already on, press the x key to turn on the monitor.

If any of the integrity checks fail, do not attempt to monitor the patient. 2 WARNING! Use another sensor or oximetry cable, or contact the equipment dealer for help if necessary.

5.

Before the sensor is attached to the patient, check the integrity of the sensor, oximetry cable, and oximeter by making sure the red light in the sensor is illuminated.

NOTE! Obstructions or dirt on the sensor’s red light or detector may cause the integrity checks to fail. Make sure there are no obstructions and the sensor is clean.

6.

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. Do not autoclave, ethylene oxide sterilize, or immerse the sensors in 2 WARNING! liquid.

2 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.

4-4

Pulse Oximeter for Sleep Screening Operation Manual

Chapter 4: Operating Instructions

Turning On the Monitor 1.

To turn on the monitor, press the x key. When turned ON, the monitor does the following: •

The pulse strength bar graph segments rapidly light the bottom and top LED.

•

The monitor's software revision is momentarily displayed. Figure 4.3: SpO2, pulse rate, and pulse strength bar graph.

1.

Patient’s SpO2 Shown Here

2.

Patient’s Pulse Shown Here

3.

Patient’s Pulse Strength Shown Here

Pulse Oximeter for Sleep Screening Operation Manual

4-5

Chapter 4: Operating instructions

Low Battery Indicator 1.

The Low Battery Indicator is the top LED segment of the pulse strength bargraph.

2.

The Low Battery Indicator will flash rapidly when the batteries need to be replaced.

3.

The Low Battery Indicator and “trn” will flash rapidly if the monitor is trying to print and there is not enough battery life for printing. This indicator will go away when the printing stops.

WARNING! When the LOW BATTERY INDICATOR flashes, you must immediately 2 replace the monitor’s batteries. Otherwise, the monitor turns itself off about 30 minutes after the highest bargraph LED begins to flash in any mode.

Turning Off the Monitor Turn off the monitor when you are not monitoring a patient. To turn off the monitor, press the x key. To turn off the monitor in the Data Collection Mode, the x key must be pressed and held for 6 seconds. NOTE! Once the monitor is powered off in the Data Collection Mode, it cannot resume collection of trend data without clearing all previously obtained data.

Checking the Monitor’s Performance Pulse oximeters do not require user calibration. If checking the function of the device is desired, an optional Oximeter/ECG Patient Simulator (Catalog No. 1606HH) is available as an accessory. The simulator attaches to the oximeter via the 3311 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 1606HH Oximeter/ECG Patient Simulator does not calibrate the monitor; the monitor does not require calibration. The 1606HH provides a known SpO2 and pulse rate to the monitor that allows you to check the monitor’s performance. NOTE! Follow the instructions included with the 1606HH Oximeter/ECG Patient Simulator.

Operating Modes The monitor has three operating modes: Verification Mode, Data Collection Mode, and Trend Printing Mode.

4-6

•

Verification Mode is intended for use in spot checking and for verification of correct sensor placement.

•

Data Collection Mode is intended for use in long-term data collection in sleep screening environments.

•

Trend Printing Mode is intended for use in the output of the trend data summation to the printer or a full computer data download.

Pulse Oximeter for Sleep Screening Operation Manual

Chapter 4: Operating Instructions

Verification Mode Verification Mode is intended for use in spot checking and for verifying that the user has correct placement of the finger sensor. •

The monitor will enter the Verification Mode as soon as trend memory is cleared.

•

In this mode the patient will be able to position the sensor on his/her finger (or appropriate site) and obtain SpO2 and heart rate data on the display.

•

This mode will last for 10 minutes of continuous valid data collection.

•

If the monitor is powered down during this mode, it will be powered up in this mode and the verification timer will be reset.

•

Once the verification timer reads 10 minutes, the monitor exits theVerification Mode and enters the Data Collection Mode.

•

The user functions in Verification Mode are: •

The display will show % SpO2 and heart rate values (if available, otherwise “dashes” [ - - ] for invalid data are displayed).

•

The x key will turn the unit OFF without changing modes.

•

Pressing the F key momentarily will not activate the printer. The printer function is suppressed in this mode.

•

Pressing and holding the F key will advance the paper (see pg. 7-5) Reloading the paper is allowed in this mode.

•

Pressing and holding the F key at power up will erase trends, even if the trend memory is already clear.

•

The serial link to the PC computer will be suppressed in this mode.

Data Collection Mode Data Collection Mode is intended for use in long-term collection of data in sleep screening environments. •

The Data Collection Mode will be entered when the verification timer reaches 10 minutes.

•

Once the trend data collection process has been started, trend memory will be filled continuously until the end-of-memory is detected (approx. 12 hours) or the monitor is powered down.

•

Invalid data (such as sensor off) is stored in trend memory, but is not used in the statistical calculations.

•

The user functions in Data Collection Mode are: •

The SpO2 display will show one flashing bar and heart rate display will be blank (see Fig. 4.4).

•

Pressing and holding the x key for six (6) seconds will turn off the unit. While pressing the x key, the flashing bar will flash at a higher frequency indicating that the unit is about to be powered down.

NOTE! If the x key is released before the six seconds elapses, the bar will return to its normal flashing pattern.

•

After the power down, the unit will power up in the Trend Printing Mode.

Pulse Oximeter for Sleep Screening Operation Manual

4-7

Chapter 4: Operating instructions

NOTE! Once the monitor is powered off in the Data Collection Mode, it cannot resume collection of trend data without clearing all previously obtained data.

•

Momentarily pressing the F key will not activate the printer in the Data Collection Mode. The printer function is suppressed in this mode.

•

Pressing and holding the F key will advance the paper (see pg. 7-5). Reloading the paper is allowed in this mode.

•

The serial link to the PC computer will be suppressed in this mode.

Trend Printing Mode The Trend Printing Mode is intended for use in the output of the trend data summation to the built-in printer or to a PC for a full computer data download. •

The Trend Printing Mode is entered after the monitor is powered down in the Data Collection Mode, and powered back up, or when the trend memory becomes full.

•

The user functions in Trend Printing Mode are: •

The SpO2 display will be blank and the heart rate display will flash “trn”. The oximetry function will be suppressed in this mode (see Fig. 4.5).

•

Pressing the x key will turn off the power. After power down, the unit will be powered up to the same Trend Printing mode.

•

Briefly pressing the F key will activate a printout (statistical sleep screening information, see Fig. 7.1) Pressing the F key during the printout will terminate the printout. Printing the printout can be repeated an unlimited number of times.

•

Pressing and holding the F key will advance the paper (see pg. 7-5). Reloading the paper is allowed in this mode.

•

Holding the F key for 6 to 8 seconds at power up will clear the trend data and switch the unit into Verification Mode (see Ch. 6).

•

The serial link to a PC will start as soon as the monitor is powered up. If a miscommunication between the monitor and the PC occurs, turning ‘Off’ the monitor and then back ‘On’ will re-establish the link. (see Appendix A for output protocol)

Figure 4.4: Data Collection Mode display

4-8

Figure 4.5: Trend Printing Mode display

Pulse Oximeter for Sleep Screening Operation Manual

Chapter 5: Instructions for Training the Home User

Chapter 5: Instructions for Training the Home User Equipment and Supplies Checklist for Home Use

QUANTITY

CAT. NO.

1 1

DESCRIPTION Handheld Oximeter

1884SSHU

Home Users Guide

*The physician or home care provider will provide the type and quantity of the sensors needed for home use. *

3044

Sensor, Reusable, Finger

*

3444

Sensor, Reusable, Finger

1

3311

Cable, Oximetry, 5 Feet (1.5 meters)

*

1300

Sensor, Disposable, Adult

*

1301

Sensor, Disposable, Pediatric

*

1310, 1311

D.O.T Sensor, Adult

*

3049

Adhesive Strips (Adhesive Tape)

The home user may also need these supplies and reference materials: 1

Scissors (for trimming adhesive strips or adhesive tape).

1

Phone number for equipment supplier in case of equipment problems.

Training the Home User 1.

Make sure all previous trend data has been printed and that the trend memory is cleared by pressing and holding the F key for 6-8 seconds at power up.

2.

Replace batteries if unsure of life expectancy (i.e. – will they last long enough to complete the sleep screening? See p.2-1 for battery life expectancy)

3.

(Following the Home User’s Guide while teaching these tasks may help you and the home user.) Show the home user how to: a. b. c. d. e. f. g. h. i. j.

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 entanglements and dangerous situations (tripping, strangulation) etc. attach the sensor prescribed by the doctor. read the SpO2, pulse rate, and pulse strength bar graph readouts displayed on the monitor. know when the monitor has gone into the Data Collection Mode and how the monitors display will look. turn off the monitor only upon completion of test. call home care provider if monitor is accidentally turned off before test completion occurs.

Pulse Oximeter for Sleep Screening Operation Manual

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