Novametrix 511 User Manual

Download

Model 511

User’s Manual

Pulse Oximeter

May 01, 1996

Catalog No. 6116-23-01/6416-23-01

the written permission of Novametrix Medical Systems Inc.

[This page intentional ly bl ank.]

ii Model 511

User’s Manual Rev. 01

Manual Revision History

Section i Manual Revision History

21-July-93 Release at revision 00.

01-Mayr-96 Revision 01 (R-N389). Includes Addendums A

through D from r evis ion 00. Single patient u se sensor information included.

Rev. 01

MOdel 511

User’s Manual iii

Section ii Guarantee

Equipment manufactured or distributed by Novametrix Medical Systems Inc., is fully guaranteed, covering materials and workmanship, for a period of o ne year fro m the date of shipment, except for certain disposable pr odu cts and pr odu cts with stated g uarantee s other than one year.

Novametrix reserves the right to perform guarantee service(s) at its factory , at an authorized repair station, or at the customer’s installation. Contact the Novametrix Technical Service Department, at the numbers listed below, to arrange for warranty repair and to receive a Repair Order Number prior to returning any equipment to Novametrix.

Novametrix’ obligations under this guarantee are limited to repairs, or at Novametrix’ option, replacement of any defective parts of our equipment, except fuses, batteries, and calibration gasses, without charge, if said defects occur during normal service.

Claims for dama ges during shipmen t must be filed promptly wi th the transportation company . All corresponden ce concerning the equipment must specify both the model name and number, and the serial number as it appears on the equipment.

Improper use, mishandling, tampering with, or operation of the equipment without following specific operating instructions will void this gu arantee and release Novametrix from any further guarantee obligations.

Service Department

For factory repair service, call toll free

1-800-243-3444

In Connecticut, call Collect (203) 265-7701

Facsimile (203) 284-0753

Caution:

order of a licensed medical practitioner. Copyright  1993, 1996, Novametrix Medical System s Inc. This document contains

information which is proprietary and the property of Novametrix Medical Systems Inc., and may not be reproduced, stored in a retrieval system, translated, transcribed, or transmitted, in any form, or by any means, without prior explicit written permission from Novametrix Medical Systems Inc.

Model 511 User’s Manual 01-May-96 iv

Federal (U.S.A.) law restricts this device to sale, distribution, or use by or on the

Section ii Guarantee

[This page intentional ly bl ank . ]

v 01-May-96

Model 511

User’s Manual

Section ii Contents

Manual Revision History Guarantee Contents Introduction

Patient Safety

Illustrations

...................................................................................................................................... iv

.......................................................................................................................................... vi

................................................................................................................................... 1

Principles of Operation.............................................................................................................. 1

Indications and Usage................................................................................................................ 2

................................................................................................................................. 3

Warnings.................................................................................................................................... 3

Cautions..................................................................................................................................... 4

.................................................................................................................................... 5

Front Panel Illustration .............................................................................................................. 5

Display Illustrations................................................................................................................... 6

Monitor Operation

Battery Installation.................................................................................................................... 7

External DC Supply................................................................................................................... 7

Power On/Off....................................................................................... ...... ................................ 8

Display Illumination and Pulse Beep Options........................................................................... 8

Audible Alarms.......................................................................................................................... 9

Saturation Auto Alert Limits .......................................................... ..... ...... ................................ 9

Battery Life.............................................................................................................................. 10

Select and Apply a Sensor to the Patient................................................................................. 10

Monitoring Saturation and Pulse Rate..................................................................................... 10

Alerts........................................................................................................................................ 11

Status Messages and Numbers...................................................................................... 11

........................................................................................................ iii

...................................................................................................................... 7

SpO2 Sensors

Finger Sensor........................................................................................................................... 13

Y-Sensor................................................................................................................................... 15

Single Patient Use SpO

Model 511 User’s Manual 01-May-96 vi

............................................................................................................................... 13

Finger Sensor Quick Check.......................................................................................... 14

Y-Sensor Application using Y-Strip Tapes.................................................................... 15

Y-Sensor Application using Ear Clip............................................................................ 17

Y-Sensor Quick Check.................................................................................................. 18

Sensors............................................................................................. 19

Instructions for Use:...................................................................................................... 19

Section ii Contents

Connecting the sensor:.................................................................................................. 19

Sensor Application........................................ ...... .................................. ..... ................... 21

Single Patient Use SpO

Sensor Quick Check.............................................................. 22

Serial Communication Option

Connecting a sensor to the Model 511..................................................................................... 23

Connecting the Model 511 for serial communication ............................................................. 24

NOVACOMM1 Interface......................................................................................................... 25

Trend Dump.................................................................................................................. 25

Date and Time............................................................................................................... 26

Setting Date and Time................................................................................................... 27

Clear Trends.................................................................................................................. 27

Exit Command ................................................................................ ...... ........................ 27

Cleaning & Sterilization

Model 511

Finger Sensor ................................................................................................................ 29

Y-Sensor........................................................................................................................ 29

Y-Strip Tapes................................................................................................................. 30

Ear Clip......................................................................................................................... 30

Specifications

General.............................. ....................................... ........................................ ........................ 31

Oxygen Saturation (SpO2)....................................... ...... ...... ................................. ...... ...... ....... 31

Pulse Rate ................................................................................................................................ 31

General Specifications............................................................................................................. 31

............................................................................................................................... 31

......................................................................................................... 29

Monitor ....................................................................................................... 29

............................................................................................. 23

vii 01-May-96

Model 511

User’s Manual

Section 1 Introduction

This manual describes the use and operation of the Novametrix Medical Systems Inc.

The

Model 511

measurement and displays for functional pulsatile oxygen saturation (SpO The monitor is powered from four standard AA size alkaline batter ies, or may be connected to an optional external power source for continuous mains operation.

Numerical SpO A pulsatile signal activity bar, battery strength indicator, and general alarm indicators are also displayed on the LCD. The controls display illumination, and an alarm key that enables/disables audible alarms, and sets alert limits.

Model 511 monitors (Cat. No. 6416-00) are av ail abl e with a serial comm unicat ions op t ion which allows patient trend information to be downloaded into the Novametrix Data Archive System or other communicating devices. Interfacing between the communicating device and the monitor is via a simple cable connection. See “Serial Communication Option” on page 23 for more information.

is a lightweight, easy to use, pulse oximeter that provides reliable

and Pulse Rate information is pres ented on a liquid crys tal display (LCD).

Principles of Operation

The

Model 511

infrared light sources, called LEDs. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared to unsaturated blood, the amount of light absorbed by the blood in each pulse can be used to calculate oxygen saturation.

The light energy from red (660 nm) and infrared (940 nm) LEDs is beamed through a sample cell—a pulsating vascular bed, the patient’s finger or toe for example. The remaining light energy not absorbed by the sample cell reaches a light receptor, ca lled a photodiode, on the opposing side of the sensor. The data received at the photodiode is sent back to the monitor where it is split into its red and infrared components, digit ized, processed by a microprocessor chip, and finally displayed as a numerical value for oxygen saturation and a plethysmogram.

The

Model 511

“fractional” saturation value displayed by most co-oximeters. Functional saturation represents the amount of oxyhemoglobin as a percentage of the hemoglobin that can be

measures oxygen saturation an d pulse rate with sens ors that contain red and

is calibrated to display “functional” saturation. This differs from the

Model 511

controls include a power on/of f switch that also

Pulse Oximeter, from

) and pulse rate.

NovaCARD

Model 511 User’s Manual 01-May-96 1

Section 1 Introduction

oxygenated. Dysfunctional hemoglobins (COHb and METHb) are not included in the measurement of functional saturation .

Calculating Functional Oxygen Saturation

Indications and Usage

HbO

Functional Saturation =

Pulse Rate is calculated by measuring the time interval between the peaks of the infrared light waveform. The inverse of this measurement is displayed as pulse rate.

The

Model 511

sensors.

The

Model 511

and pulse rate. T he pediatric and neonatal.

must be used in conjunction with OxySnap SuperBright™ saturation

Pulse Oximeter is intended to be used for monitoring of oxygen saturation

100 - (COHb + METHb)

Model 511

is designed to monitor all patient areas including adult,

HbO2 = Fractional Hemoglobin COHb = Carboxyhemoglobin METHb = Methemoglobin

2 01-May-96

Model 511

User’s Manual

Section 2 Patient Safety

For maximum patient and operator safety, the following are recommended;

•

Failure of Operation:

situation has been co rrected by qualified personnel.

• Keep the

• Do not operate the

• Care should be exercised to assure continued peripheral perfusion distal to the SpO sensor site after application.

Model 511

If the monitor fails to respond as described, do not use it until the

and its accessories clean.

Model 511 Model 511

when it is wet due to spills or condensation. if it appears to have been dropped or damaged.

Warnings

Do processed when the cuff is inflated. Attach the sensor to the limb opposite to the site used for the blood pressure cuff.

•

Explosion Hazard:

anesthetics. Use of this instrument in such an environment may present an explosion hazard.

•

Electrical Shock Hazard:

use a damaged sensor or one with exp osed electrical contacts. Do not use with a damaged external power source or one with a damaged cord. Refer servicing to qualified service personnel.

•

Failure of Operation:

situation has been co rrected by qualified personnel.

•

Patient Safety:

to the SpO

•

Data Validity:

be caused by;

attach an SpO

NOT

Indicates a potentially harmful condition that can lead to personal injury.

Care should be exercise d to assur e continued p eripheral perfusion d istal

sensor site after application.

As with all pulse oximeters, inaccurate SpO

• Incorrect application or use of a sensor

• Significant levels of dysfunctional hemoglobin; carboxyhemoglobin or methemoglobin

• Significant levels of in docy ani ne g reen, met hy lene bl u e, or ot her i ntravas cul ar dyes

sensor distal to a blood pressure cuff. Valid data

Warning

Do NOT use the

Always turn the

If the monitor fails to respond as described, do not use it until the

Model 511

(continued next page)

in the presence of flammable

Model 511

off before cleaning it. Do NOT

and Pulse Rate values may

CANNOT

Model 511 User’s Manual 01-May-96 3

Section 2 Patient Safety

Cautions

• Exposure to excessive illumination such as surgical lamps—especially ones with a xenon light sour ce, or direct su nlight

• Excessive patient movement

• Venous pulsations

• Electrosurgical interference

Caution

Indicates a condition that may lead to equipment damage or malfunction.

• Do not operate the

• Never sterilize or immerse the monitor in liquids.

• Do not sterilize or immerse sensors except as directed in this manual.

• No tension should be applied to any sensor cable.

• Do not store the monitor or sensors at temperatures less than than 1

• Do not operate the monitor or sensors at temperatures less than than 130° F (

• Caution: Federal (U.S.A.) law restricts this device to sale, distribution, or use by or on the order of a licensed medical practitioner.

F (55° C).

31°

54.4°

Model 511 Model 511

C).

when it is wet due to spills or condensation. if it appears to have been dropped or damaged.

F (-10° C) or greater

14°

F (0° C) or greater

32°

4 01-May-96

Model 511

User’s Manual

Section 3 Illustrations

SpO

beats/min

SATURATION PULSE RATE

Saturation and Pulse Rate display identifiers

Display, see next section

Po wer On/Off control

511

Pulse Oximeter

Audible Alert Enable/disable Key

DC Input Jack

Front Panel Illustration

Model 511 User’s Manual 01-May-96 5

Section 3 Illustrations

SENSOR OFF PATIENT

Displays “blanked” (dashes)

Message displayed as needed

Status number displayed as needed

Display Illustrations

Typical display

Typical alert condition display

All displays illuminated

Saturation display (0-100)

Pulse Rate display (30-250) Pulse Activity Bar (16 bars)

Audible Alert Disabled Icon Battery Indicator (3 levels)

Full Half Low

UNIT/SENSOR ERROR REPOSITION SENSOR SENSOR OFF PATIENT SENSOR DISCONNECT

6 01-May-96

Model 511

User’s Manual

Section 4 Monitor Operation

Battery Installation

Top of monitor

Bottom of monitor

The

Model 511

should not be used with the

WARNING: Use of improper batteries may present a risk of fire or explosion.

To install batteries into the monitor:

1. Locate the battery compartment cover on the back side of the monitor.

2. Press the “OPEN” area o f the com par tment cover, slide the cover in the directio n indicated by the arrow, and remove the cover.

3. Install new batteries according to the “+” and “-” symbols on the bottom of the battery compartment and on each battery.

WARNING: Alkaline batteries may explode or leak if recharged, inserted improperly or disposed of in a fire. Do not open batteries.

4. Slide the battery cover back into place. The cover latches into place when properly seated.

operates on four (4) 1.5 volt “AA” alkaline batteries. Other battery types

Model 511

External DC Supply

The

Model 511

DC power jack located on the lower right side of the m onitor . Th e external supply dra ws its power from the mains. Both 105-130 VAC and 230 VAC (50/60Hz) versions are available.

When the external power supply is used, the batteries are disconnected from the monitor internally, howe ver the battery icon displays a fully charged condition. While powered from the external supply the battery icon does not reflect the condition of the batteries. When changing operation from the external supply to battery (external supply disconnected) allow the monitor to run for one minute, after which the icon will reflect the true batt ery charge.

can be powered by an external DC supply. The supply plugs into the small

WARNING: U se only Novametrix supplied external power supplie s. The use of other external power sources may jeopardize patient safety, or may damage the

Model 511 User’s Manual 01-May-96 7

Model 511

Section 4 Monitor Operation

Power On/Off

1. To turn the monitor on, press and hold the power control.

2. To turn the monitor off, press the power control.

Display Illumination and Pulse Beep Options

A tone sounds to verify audio is functional, the monitor performs a system self-test, all display segments are briefly illuminated, the software version is displayed, the number “1” will be displayed in the alert triangle, it will then sequence through to “4”. Release the power control key when the desired number is displayed (illumination/pulse beep options). Reference the next section “Display Illumination and Pulse B eep” for an explanation on the options available.

If the power control key is pressed, but not held the monitor will power up as described above and will default to selection of “1” for the illumination/pulse beep options (both OFF).

SpO

and pulse rate information wi ll be displayed withi n 20 seconds of po wer up, pro vided

the sensor is properly applied to the patient prior to power up or prior to the completion of any monitor self test.

The Model 511 is supplied with a display illumin ation option, this is designed for better viewability under low ambient lighting conditions. A pulse beep option is also available, this will emit a tone w ith each pulse dete cted by the monitor. These options are sele cted or deselec ted at power up by holding the power control key until the desired option combination number is displayed, then releasing the power control key to select that number.

There are four possible options in regards to display illumination and pulse beep when powering on the Model 511. The four options wil l a ppea r i n se que nc e in th e status field as numbers one through four, these are identified below:

Option

Number Illumination Pulse Beep

1 Illumination OFF Pulse Beep OFF 2 Illumination OFF Pulse Beep ON 3 Illumination ON Pulse Beep OFF 4 Illumination ON Pulse Beep ON

1. To select one of the four display illumination/pulse beep options press and hold the power control key when the monitor is off.

The monitor will power up as described in “Power On/Off” on page 8. The status number field will display “1” inside the alert triangle, it will then chang e to “2” and sequence through to “4”. If the power control key is still held after the “4” is displayed the m onitor will shut off.

2. To select th e desired option rel ease the power control key when the a ppropriate number is displayed inside the alert triangle.

3. To select another option, press the power control to turn the monitor off. Press and hold the power control to turn the monitor back on and select another option number.

8 01-May-96

Model 511

User’s Manual

Audib le Alarms

Alert limits shown for 3 seconds (default values shown here)

Audible alert icon shown when audible alert is disabled

Display showing alert limits when audible alert is enabled

Audible Alarms

1. To toggle between enabled and dis abled audible alarms, press and relea se the alarm key.

If pressing and releasing the alarm key causes the alarms to be enabled, the monitor shall display the saturation auto alert limit settings (in the SpO seconds, beep once, and turn off the alarm icon. The alarm display icon will not be displayed while audible alarms are enabled. All visible alerts continuously acti ve for long er than 10 seconds will cause an unlatched audible alarm to sound.

and pulse rate displays) for three

Typical display with audible alert icon displayed

NOTE: Disabling and re-enabling the audible alarms will reset the ten second delay clock when an alert condition exists.

If pressing and releasing the alarm key causes the alarms to be disabled, the monitor shall beep once, and turn on the alarm icon. The alarm display icon will illuminate as a warning that the audible alarms are disabled.

NOTE: W ith the audible alarms disabled, the audible alarm will condition.

Saturation Auto Alert Limits

sound under any alert

not

Model 511

1. To set aler t limits, press and hold the aler t key for more than 2.5 seconds. The monitor will beep twice if new limits are set (based on valid SpO SpO

is displayed, the monitor will use default limits and will beep three times.

The

Model 511

User’s Manual 01-May-96

rate display for three seconds. The monitor will then return to normal operation .

NOTE: Setting alert limits automatically enables the audible alarms.

will display the high limit in the SpO

values). If no

display and the low limit in the pulse

Section 4 Monitor Operation

2. T o displa y limits without setting new limits if audio is enabled, press and release the

3. To display limits without setting new limits if the audio is disabled (audible alert icon

Battery Life

alarm key twice. The first press turns off the alarms and the second turns them back on and causes the high and low limits to be displayed for three seconds. The monitor will then return to normal operation.

visible), press and release the alarm key. The high and low limits will be displayed for three seconds before the mo nitor returns to no rmal operation. Pre ss and release the alarm key to disable the audible alarms.

The

Model 511

• fully charged batteries, over 4 hours of battery life

• less than 4 hours of battery life

• indicates less than 2 hours of battery life

• (flashing) less than 15 minutes of battery life When the battery voltage reaches the 2 hour level , the battery is very low. As the battery

reaches near depletion, the battery icon will flash at a rate of once per second, and the alert audio will sound, this alert tone cannot be muted (even if alerts are disabled). Continued use of the monitor at this point will result in the monitor shutting itself off.

NOTE: The above information is based upon normal monitoring conditions (e.g. sensor on patient, new alkaline batteries). Use of non-alkaline, previously used alkaline, or rechargeable alkaline batteries will affect the battery life times. Prolonged use of the backlight can significantly reduce overall battery life.

The battery icon may appear fully charged for the first minute after power up, after which it will reflect the true battery charge. NOTE: When oper ating from th e external po wer supp ly the battery ico n does not reflect the condition of the batteries. See “External DC Supply ”.

displays a battery icon to indicate:

Select and Apply a Sensor to the Patient

Refer to Section 5.

Monitoring Saturation and Pulse Rate

Once the applied to the patient, numerical SpO display. A “pulse activity bar”, derived from the pulsatile signal, is also displayed. The monitor automatically adjusts the activity bar’s length to produce an easily visible display.

Verify the pulse activity bar reflects the patient’s pulse. The bar should show regular rhythmic movement. Erratic or non-rhythmic pulse bar activity may indicate a poorly positioned or applied sensor, or may be indicative of excess patient movement at the sensor site. Check the sensor site and if necessary, attempt to reduce patient movement.

Violation of the upper or lower saturation auto alert limits shall immediately cause a “H” or “L” to flash within the borders of the display alarm icon, even if the icon itself is disabled.

Model 511

10 01-May-96

is powered on and a sensor is connected to the monitor and properly

and Pulse Rate values appear on the monitor’s

Model 511

User’s Manual

Alerts

SENSOR OFF PATIENT

Message displayed as needed

Status number

Typical status message and number display

Alerts

If the

Model 511

previous contents of the display shall be “held”. Should the display be held for more than ten seconds, a “-” character will start to flash within the borders of the display alarm icon, even if the alarm icon itself is disabled. If the from the sensor within sixty seconds, the saturation and pulse rate displays will blank out (display “--” and “---” respectively). If the display is held longer than ninety seconds the

Model 511

along with the number 9 will appear in the display. If at any time the monitor processes valid data with which to update the display, the “-” will stop flashing, the display w ill be updated, the timer reset to zero (seconds), and the audible alarm, if active, will be reset.

cannot detect “valid” saturation data with which to update the display, the

Model 511

will emit an audible unlatched alarm (if enabled) and REPOSITION SENSOR

cannot detect valid pulsatile data

Status Messages and Numbers

The

Model 511

conditions:

will display status messages and related status numbers under certain

Summary of status messages and numbers.

The following table lists the conditions that cause status m e ssages to be displayed.

Message Number Condition

Sensor Disconnect 1 Sensor not connected to monitor. Sensor Off Patient 2 Sensor not applied to the patient. Reposition Sensor 3 Low signal strength. Pulse strength as detected by the

sensor is too small for proper monitor operation.

Reposition Sensor 4 Insufficient light. Sensor placed on a site too thick (or

opaque) for adequate light transmission. Reposition Sensor 5 Pulse out of range. Pulse must be 30-250 bpm inclusive. Reposition Sensor 6 Light Interference. Ambient light sources (sunlight,

warming lights, etc.) are interfering with sensor

operation. Shield sensor from these light sources. Unit/Sensor Error 7 Sensor fault. Remove sensor from use and contact

qualified service personnel. Unit/Sensor Error 8 Monitor fault. Record the error num ber that appears in

the pulse rate display. Remove the monitor from use and

contact qualified service personnel. Reposition Sensor 9 Bad signal, monitor not receiving valid signals from

sensor. May be caused by excessive motion, cardiac

arrhythmia or other situations leading to poor signal.

Check patient status, reposition sensor.

Model 511

User’s Manual 01-May-96

Section 4 Monitor Operation

All status condition s except for Unit/Sensor Error wil l reset automatically once the condition is corrected. Unit/Sensor Error conditions are latching conditions—that is you must replace the sensor for a sensor fault, or turn the before the monitor fault is reset.

Model 511

off and fix the problem

12 01-May-96

Model 511

User’s Manual

Section 5 SpO2 Sensors

OxySnap Connector

OxySnap Finger Sensor

The

Model 511

WARNING: Connect only Novametrix OxySnap SuperBright saturation sensors to the

Model 511

Before connecting to the patient or to the with no broken, frayed or damaged co mpo nents. Ensure the connector s are clean and dry, with no signs of contamination or corrosion. Do not use a broken or damaged sensor or one with wet, contaminated or corroded connectors.

To attach an OxySnap SuperBright sensor to the

1. Align the arrows on the Oxy

Model 511

2. To disconnect, grasp the connectors at the finger grips and pull them apart.

Pulse Oximeter requires OxySnap SuperBright SpO2 Sensors.

. DO NOT use other sensors or accessories with the

Model 511

Snap

connectors and press the connectors together.

, ensure sensors are physically intact,

Model 511

Finger Sensor

The Finger Sensor is intended for adult fingers and not designed for neonatal or pediatric applications.

Sensor

Before applying the sensor to the patient, verify the sensor is physically intact, with no broken/frayed wires or damaged parts. Ensure the connectors are clean and dry, with no signs of contamination or corrosion. Do not use a broken or damaged sensor or one with wet, contaminated or corroded connectors.

Model 511 User’s Manual 01-May-96 13

Section 5 SpO2 Sensors

Applying the F inger Sensor to the Patient

To apply the finger sensor to the patient;

1. Gently squeeze the grips at the rear of the sensor (indicated by arrows below).

Cable exits above fingerPlacement Guide

2. Position fingertip against placement guide with fingernail towards the red light.

Do not position the finger so as to protrude past the placement guide.

3. Release the finger grips.

4. Inspect the site often for adequate circulation—at least once every four hours.

5. To remove sensor, gently squeeze grips and slide the sensor from the finger.

CAUTION: Overstretching the pulse oximeter finger sensor can damage the sensor and potentially affest pulse oximeter readings. Do not stretch the finger sensor open beyond the limit for which it was designed. Overstretchin g can be preventerd: avoid opening the sensor by any means other than squeezing the grips; objects such as bedrails.

DO NOT

force the sensor onto large

Finger Sensor Quick Check

1. Is Probe Off Patient illuminated when the se nsor is connected to the monitor but not applied to the patient?

2. Apply the sensor to your index finger. Are reasonable SpO displayed?

3. A YES to BOTH #1 and #2 indi cates the sensor is OK . Apply the sensor to th e patient as instructed above.

The quick check also tests the functionality of the extension cable.

and pulse rate values

14 01-May-96

Model 511

User’s Manual

OxySnap Y-Sensor

Y-Sensor showing Center Strip removed

Y-Sensor

The reusable Y-Sensor is a flexible versatile sensor designed for use on any patient.

The Y -Sensor’ s Center Strip is not a functional part of the sensor. Its purpose is to aid in the placement of the sensor into the tape or other securing system. The center strip may be removed (carefully cut a way) if th e distance between the sensor heads needs to b e changed from 25 mm.

Sensor Heads

Y-Strip Application Sites and Catalog Numbers

Model 511

User’s Manual 01-May-96

Center Strip

Strip may be removed

Y-Sensor Application using Y-Strip Tapes

1. Select a Y-Strip based on the patient type and intended sensor location.

Y-Strips come in two color coded sizes: 25 mm tapes are coded green, and 20 mm tapes are coded blue. The size refers to the distance between the holes in the tape.

Wrap Style Tape

Cat. No. 8829 25 mm (Green) Neonatal Foot,

Hand

Cat. No. 8828 20 mm (Blue)

Neonatal Foot, Hand

Pediatric Toe, Finger

Cat. No. 8836

Non-adhesive Foam

Wrap

Section 5 SpO2 Sensors

Liner this side (top)

Y-Strip Tape

Head

Button

Cross Section

Remove release liner with holes.

Y-Sensor placed on Y-Strip tape.

Finger Style Tape

Cat. No. 8832

25 mm (Green)

Adult Finger

2. Remove the portion of the release liner containing the holes.

Cat. No. 8828/8829

Skip this step if using the 25 mm Y-Strip tape.

3. If using the 20 mm Y- Str i p ta pe, carefully remove the sensor’s center strip usi ng a pair of scissors or a sharp blade.

The center strip does not effect sensor operation, its purpose is to aid putting the sensor into the 25 mm tape.

4. Press the “button”, on the back of each sensor head, through a hole in the tape.

Press in from the sticky side of the tape. The tape will stretch to fit the sensor button.

Cat. No. 8831 20 mm (Blue)

Pediatric Finger

Adult Finger

Cat. No. 8831/8832

5. Remove the remaining release liner and apply the sensor/tape to the patient.

Do not wrap the tape around the limb so tightly that circulation is restricted. Inspect the site often for adequate circulation—at least once every four hours.

Ensure that the sensor heads are directly opposite each other through the tissue.

prevents the sensor from being placed on a site too thick (high arch) for proper operation. Position the sensor so that the tape does not extend over the space between the fingers or

toes to insure there will be no light transmission through this space.

16 01-May-96

6. To maximize sensor life, secure the sensor to the patient with additional tape.

Model 511

This

User’s Manual

Y-Sensor applied to

SENSOR HEADS

CENTER STRIP (REMOVE)

EAR CLIP RECEPTACLE

SENSOR HEAD

SQUEEZE HERE TO APPLY

patient

Leave slack in the wires between the tape and the sensor.

Adult/Pediatric Finger

Y-Sensor

Neonatal Hand

Y-Sensor before attachment to Ear Clip

Y-Sensor placed on Ear Clip

Neonatal/Pediatric Foot

7. Inspect the site often for adequate circulation—at least once every four hours.

Pediatric Toe

Y-Sensor Application using Ear Clip

1. Remove center strip from the Y-Sensor.

2. Slide each Y-Senso r head into the ear clip‘s receptacl es, the heads should face each other.

Model 511

User’s Manual 01-May-96

3. Gently squeeze the end of the ear clip (shown in diagram), and apply the sensor to the patient.

Section 5 SpO2 Sensors

ADULT EAR

OPTIONAL PLACEMENTS

Y-Sensor with Ear Clip placed on patient ear

If a satisfactory readi ng canno t be obtained, rub the site and/or use adhesive dots for better response. The adhesive dots (PN: 8700-00) included with the ear clips will also he lp in preventing the ear clip from falling off (e.g. during exercising).

W AR NING: Inspect the site often for adequate circulation—at least once e very four ho urs. When applying sensors take note of patient’s physiological condition. For example, burn patients may exhibit more sensitivity to heat and pressure and therefore additional consideration such as more frequent site checks may be appropriate.

Y-Sensor Quick Check

1. With the Y-Sensor con nected to monitor but not applied to patient, position th e sensor heads so that they face each other (the r ed light shines at the detector). Is Probe Off Patient illuminated?

2. Tape the Y-Sensor to your index finger. Does the monitor shows reasonable SpO and pulse rate values?

3. A YES to BOTH #1 and #2 indi cates the sensor is OK . Apply the sensor to the patient as instructed above.

The quick check also tests the functionality of the extension cable.

18 01-May-96

Model 511

User’s Manual

Single Patient Use SpO2 Sensors

Model 511

DB-9

Connector

Cable

Intended Use: The Single Patient Use SpO

monitoring adult, pediatric or neon atal patients with Novametrix Pulse Oximeters (SuperBright™ series). These sensors are used with the DB-9 connector cable.

WARNING:

Novametrix SuperBright compatible pulse oximeters. Use with any other device may result in equipment damage or patient injury.

CAUTION:

reapplied to various sites on the same patient but should not be used on multip le patients. Do not attempt to clean or disinf ect the sensor, as system performance will be compromised.

NOTE:

question.

Use the Single Patient Use sensor and DB-9 connector ca ble only with

These SpO2 sensors are intended for single pa tient use. The sensors can be

The Single Patient Use sensor should be discarded if sensor integrity becomes a

Instructions for Use:

sensors (Catalog Nos. 6480 a nd 6455) can be used wh en

Single Patient Use SpO2 Sensors

Model 511

Connecting the sensor:

1. Attach the DB-9 to OxySnap conne cto r ca ble to th e Model 511. Align the a rrows on the OxySnap connectors and press the connectors together.

Model 511

User’s Manual 01-May-96

Section 5 SpO2 Sensors

Model 511 with RS232 option

6292-01 cable

DB-9 to

OxySnap

Connector

Model 511 with RS232

DB-9 connection

20 01-May-96

2. Press the black connector on the en d of the DB-9 to OxySnap extension cable into the black connector on the end of the Single Patient Use SpO

sensor

connector

DB-9 to

OxySnap

connector

sensor.

Model 511

User’s Manual

Single Patient Use SpO2 Sensors

3. T o disconnect the DB-9 to

OxySnap

connector cable, grasp the connectors and pull them apart (the DB-9 to OxySnap connector can remain attached to the Model 511 as long as single patient use sensors will be used).

Sensor Application

1. Select the appropriate size sensor based on the patient type.

PEDIATRIC/ADULT SENSOR

ADULT TOE

ADULT FINGER

NEONATAL/PEDIATRIC SENSOR

NEONATAL HAND

PEDIATRIC TOE

NEONATAL FOOT

2. Apply the sensor by placing the blue side of the sensor wrap against the skin, wrap it around the site (cut excess foam if necessary) and secure with Velcro® tab. The V elcro tab on the neonatal/pediatric version is removable to allow the foam wrap to be cut before applying to the patient.

CUT EXCESS OFF

NEONATAL/PEDIATRIC

SENSOR

VELCRO TAB

Ensure that sensor heads are positioned directly opposite each other through the tissue. The adhesive dots (Cat No 8700) which are included with each sensor can be applied the

sensor before patient application for additional adhesion to the site.

Model 511

User’s Manual 01-May-96

Section 5 SpO2 Sensors

3. For additional support, secure the cable along the limb with tape.

WARNING: Do not wrap the sensor around the limb so tightly that circulation is restricted. Inspect the site often, at least every four hours, for adequate circulation. When applying sensors, t ake note of patients phy siological condition. F or examp le, burn p atients may exhibit more sensitivity to heat and pressure and therefore additional consideration such as more frequent site checks may be appropriate

Single Patient Use SpO2 Sensor Quick Check

1. With the sensor connected to the monitor but not applied to the patient, position the sensor heads so that they face each other (the r ed light shines at the detector). Is PROBE OFF PATIEN T displ ayed?

2. Apply the sensor to your index finger. Are reasonable SpO displayed?

3. A YES to BOTH #1 and #2 indi cates the sensor is OK . Apply the sensor to th e patient as instructed above.

This quick check also tests the functionality of the DB-9 to

and pulse rate values

OxySnap

connector cable.

22 01-May-96

Model 511

User’s Manual

Section 4 Serial Communication Option

Model 511

6292-01 cable

OxySnap

connection for

SuperBright™

sensor

Connecting a sensor to the Model 511

Model 511

which allows patient trend information to be downloaded into the Novametrix Data Archive System or other communicating devices. A 15-pin mini-D connector (

PATIENT/SERIAL INTERFACE

cable (Novametrix Cat. No. 6493-01) is required for connection between the monitor and the communicating device.

The communication. When attaching a sensor for patient monitoring, the 6292-01 cable must be connected to the the cable. When utilizing the monitor for serial communication the 6293-01 interf ace cable must be used, this cable terminates in a 9 pin D female for connection to the communication device.

monitors (Cat. No. 6416-00) are av aila ble with a serial communications option

) on the top panel indicates the optio n is installed. An in terface

PATIENT/SERIAL INTERFACE

connector is shared between patient monitoring and serial

, the sensor will plug into the other end of

Connecting a sensor to the Model 511

1. Plug the 6292-01 cable into the PATIENT/SERIAL INTERFACE connector.

NovaCARD

2. Connect an

3. Apply the sensor as described in “Y-Sensor” on page 15.

Model 511 User’s Manual 01-May-96 23

OxySnap

Finger or “Y” sensor into the end of the cable.

Section 4 Serial Communication Option

Model 511

6293-01 cable

Connection to computer or communication device

Connecting the Model 511 for serial communication

1. Unplug any sensor that may be connected from the connector.

2. Connect the 6293-01 interface cable to the the monitor, plug the other end into the communication device.

PATIENT /SERIAL INTERFACE

PATIENT/SERIAL INTERFACE

connector on

3. If using the NovaCARD Data Archive System, please refer to the NovaCARD User’s Manual (Cat. No. 6066-23) for set-up and o peration of the Nova COMM interface. (See “

NovaCOMM

section).

4. If you are using a communications package other than appropriate commands from the device to the monitor as i nstructed in the next section titled “

NOVACOMM1

24 01-May-96

Setup (Direct Cable)”, page 13 under the “Hardware Setup”

NovaCARD

Interface”.

Model 511

send the

User’s Manual

NOVACOMM1 Interface

T********************************<cr><lf>

byte 0

byte 15

NOVACOMM1

The

NOVACOMM1

or data logging device. The computer interface provides the user the ability to “dump” trend information to a computer file for later analysis. The communication format is 9600 baud, 8 bits, no parity, 1 stop bit and XON/XOFF handshaking.

Trend Dump

Trend data is transmitted as a succession of records. The record size for bytes of ASCII Hexadecimal data. A record can be one of two types, an INFO record or a DATA record. The INFO record contains monitor information such as time of day, date, limit settings, and units. The DAT A record contains ev ent marker, audio disable, SpO pulse rate values.

The first record sent is always buffer , then recor ds would continue being sent in chronolo gical order from the ol dest record to the newest record. In normal monitoring use, an INFO record would be followed by 15 data records, followed by another INFO record and then another 15 data records, etc. Turning the monitor off, or changing the limits will disrupt this sequence. When this occurs a new INFO record will be sent and indicate the time and date, along with the current limits. At this point, unless another exception occu rs, the next I NFO record will be fo llo wed by 15 DATA records.

An INFO record can be distinguished from a DATA record by the first byte. The first byte of an INFO record is FF, the first byte of a DATA record is 00-C8 (0-200 decimal), or FB (pen lift or no data available). Any other values are not applicable. The DATA record uses 8 data points per parameter, at 8 second resolution, for a total of 64 seconds of trend data per data record.

To reques t trend dump, the computer must send an ASCII “6” character. The monitor echoes back the “6” character and transmits the first INFO record.

The Mode 6 data format is; INFO record;

Interface

interface is designed to output data in fo rmats easily read by a computer

Model 511

an INFO record. This record reflects the oldest data in the

is 16

, and

where; T- Trend mode identifier **-INFO byte, starting at byte 0 and ending at byte 15 (see below)

byte -0 flag byte = FF for INFO record

INFO record byte assignment

Model 511

User’s Manual 01-May-96

byte-1 information type (FE-power on, FD-limit change,

FC-time stamp) byte-2 model code = 2 byte-3 compression ratio = 8 (i.e. 1 point/8 seconds) byte-4 seconds (0-59) byte-5 minute (0-59) byte-6 hour (0-23) byte-7 day (1-31)

Section 4 Serial Communication Option

T**************** ****************<cr><lf>

byte 0

byte 15

d•MMM/DD/YY•hh:mm:ss<cr><lf>

byte-8 month (1-12) byte-9 year (0-99) byte-10 unused byte-11 unused byte-12 unused byte-13 unused byte-14 unused byte-15 unused

DATA record;

<cr> - carriage return <lf> - line feed

T - Trend mode identifier **-DATA byte, starting at byte 0 and ending at byte 39 (see below)

DATA record byte assignments

byte 0-7 8 byte SpO2 data, rang e: 01-28 Hex (1-40 de cimal)

(corresponds to 60-100%, i.e. a value of 1E Hex that corresponds to 30 decimal will indicate an SpO2 value of 90%), 00-no data available. The MSB and second MSB (bits 7 & 6) of the SpO2 bytes are not used in this monitor and should be masked out.

byte 8-15 8 byte pulse rate data, range: 00-FA Hex (0-250

decimal), FB Hex (251 decimal) - no data available over period.

<cr> - carriage return <lf> - line feed

Date and Time

Date and Time mode causes the calculated by the monitor’s internal calendar clock.

T o request the date and time, the computer must send an ASCII “d” character. The monitor echoes back the “d” character and sends the date and time on the same line. The Mode d data format is;

where;

- the echoed command character

- is an ASCII space character

•

- a 3-character month (Jan, Dec),

MMM

- a 2-digit ASCII day (01, 31),

- the last 2-digits of the year (1990 is 90),

- a 2-digit hour based on a 24 hour clock (00, 23),

Model 511

to transmit, on request, the date an d time as

26 01-May-96

Model 511

User’s Manual

NOVACOMM1 Interface

sMM/DD/YY•hh:mm:ss

- a 2-digit minute,

- a 2-digit second,

ss <cr><lf>

is a carriage return, line-feed sequence.

Setting Date and Time

To set the date and time the computer must send the ASCII “s” character. The “s” is the command to set the time. The mode of the data format is;

where;

- is an ASCII space character

•

- the echoed command character

- a 2-digit month number (01, 12),

- a 2-digit ASCII day (01, 31),

- the last 2-digits of the year (1990 is 90),

- a 2-digit hour based on a 24 hour clock (00, 23),

- a 2-digit minute,

- a 2-digit second.

There must be a delay of at least 20 msec between bytes so the data receive buffer will not overflow. When the monitor has received the complete command it will echo the date in the format described in the section above.

Clear Trends

Clear Trends mode allows the user to remotely cl ear the action has the same result as the monitor’s Clear Trend function in that trend memory and the Trend Page displays are cleared.

Use this remote Clear Trends function with care as there is no way to undo the clear command once issued.

T o clear the

Model 511

cleared.

Model 511

will echo the “c” followed by a

trend memory, the computer must send an ASCII “c” character. The

Model 511

and then the trend memory will be

trend memory This

Exit Command

To exit the NOVACOMM1 mode, the computer must send an “x” or “X” character. The

Model 511

character will start communication again.

will echo the “x” and then stop communication. Sending a ne w valid command

Model 511

User’s Manual 01-May-96

Section 4 Serial Communication Option

[This page intentional ly bl ank.]

28 01-May-96

Model 511

User’s Manual

Section 6 Cleaning & Sterilization

Follow the cleaning and sterilization instructio ns listed below to clean an d/or steri lize the

Model 511

Model 511 Monitor

• Turn the monitor off before cleaning.

• Clean the monitor surface with a cloth dampened with an isopropyl alcohol 70% solution or bleach 10% solution or with the cold liquid sterilants Cidex™, or Sporicidin™, then wipe down with a clean water dampened cloth and dry before use.

• Do not immerse the monitor.

• Do not attempt to sterilize the monitor.

Finger Sensor

• Clean the Finger Sensor surface with a cloth dampened with an isopropyl alcohol 70% solution or bleach 10% solution or with the cold liquid sterilants Cidex™, or Sporicidin™. After cleaning wipe the sensor down thoroughly with a clean water dampened cloth to rinse.

• Ensure the Finger Sensor windows are clean and dry before reuse.

• Do not immerse the Finger Sensor.

• Do not attempt to sterilize the Finger Sensor.

• After cleaning the Finger Sensor, verify the sensor is physically intact, with no broken/ frayed wires or damaged parts. Ensure the connectors are clean and dry, with no signs of contaminatio n or corrosion. Do not use a broken or damage d sensor or one with wet, contaminated or corroded connectors.

• Perform a Finger Sensor Quick Check test before returning the sensor to patient use. Refer to “Finger Sensor Quick Check” on page 14.

and its accessories.

Y-Sensor

• The Y-Sensor may be immersed—up to, but not including, the connector, in a glutheralhyde solution, 10% bleach solution or Sporicidin™. Refer to manufacturer’s instructions and standard hos pi ta l prot ocol s to determi ne recomm ended times for disinfection/sterilization.

• Rinse thoroughly with water and dry before use.

• Do not attempt to sterilize Y-Sensor except as stated above.

• Do not immerse the connector on the Y-Sensor.

Model 511 User’s Manual 01-May-96 29

Section 6 Cleaning & Sterilization

• After cleaning/sterilizing the Y-Sensor, verify the sensor is physically intact, with no broken/frayed wires or damaged parts. E nsure the con nector s are clean and dry, with no signs of contamination or corr osion. Do not use a broken or damag ed sensor or one with wet, contaminated, or corroded connectors.

• Perform a Y-Sensor Quick Check test before returning the sensor to patient use. Refer to “Y-Sensor Quick Check” on page 18.

Y-Strip Tapes

• Treat Y-Strip Tapes in accordance with hospital protocol for single-patient use.

Ear Clip

• Clean the ear clip with a cloth dampened with 70% isoprophyl alcohol. After cleaning wipe the ear clip down thoroughly with a clean water dampened cloth to rinse.

• Do not immerse the ear clip.

30 01-May-96

Model 511

User’s Manual

Section 7 Specifications

General

Specifications for the Novametrix purposes only, and are subject to change without notice.

Oxygen Saturation (SpO2)

• Range, 0-100%

• Accuracy, 80-100% ± 2%, 0-79% unspecified (Approximately 68% of the observations are within the accuracy claim.)

• Display Resolution, 1%

• Averaging Time, fixed at 8 seconds

• Settling Time Display settles to within 1% of the final reading less than 15 seconds after the sensor is properly applied.

Pulse Rate

• Range, 30-250 beats per minute (bpm)

• Accuracy (Approximately 68% of the observations are within the accuracy claim.)

• Display Resolution, 1 bpm

• Averaging Time, fixed at 8 seconds

• Settling Time Display settles to within 1% of the final reading less than 15 seconds after the sensor is properly applied.

1% of full scale

, ±

Model 511

Pulse Oximeter, are listed for informational

General Specifications

• Operating Environment 50-104° F (10-40 °C), 0-90% relative humidity (non-condensing)

• Weight, 13 ounces including batteries

•Dimensions Height 6.25 inches, Width 3.75 inches , Depth 1.3 inches

Model 511 User’s Manual 01-May-96 31

Section 7 Specifications

•Battery Type, four “AA” alkaline cells. Life, 12 hours.

• External power supply Input: 105-130 VAC, 50/60Hz* or 230 VAC, 50/60Hz** Output: 6VDC @ 150ma Cord length: 6 ft. *105-130 volt unit designed to meet electrical tests of U. L. 544 Patient Care Equipment-Patient Connected/Isolated **230 volt unit designed to IEC601 Electrical Specification

32 01-May-96

Model 511

User’s Manual

Novametrix 511 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual