dinamap pro series operation manual - elite medical ny · dinamap@ pro monitor is classified in the...

DlNAMAP@ PROSeries 100-400 Monitor

Operation Manual

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The model of the Monitor determines which menu optionbuttons appear on the LCD. Please refer to applicablesections.

Reissues and UpdatesChanges occurring between issues are addressed throughChange Information Sheets, Addendums, and replacementpages. If a Change Information Sheet does not accompanythis manual, it is correct as printed.

Errors and OmissionsIf errors or omissions are found in this manual, pleasenotify:CritikonMarketing Services4502 Woodland Corporate BoulevardTampa, FL 336141-877-274-8456

Part No. 776995C

The content of this document including all figures anddrawings is proprietary information of Critikon, providedsolely for purposes of operation, maintenance or repair, anddissemination for other purposes or copying thereof isprohibited without prior written consent by Critikon, Tampa,Florida.

Illustrations may show design models; production units mayincorporate changes.

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l PRO 400: BP, Pulse, Temp, and

400, all with printers.

l PRO 100: BP and Pulse

l PRO 200: BP, Pulse, and Temp

l PRO 300: BP, Pulse, and

DINAMAP@ PRO Monitor Models 100,200, 300, and

Df NAMAP” PRO MonitorOperation Manual

This manual is for

.62Alarms Button ......................................................................................................... 62

Appendix A .......................................................................... 63Technical Specifications ..... . .................................................................................. 63

.......................................................................................................58Error and Warning Messages ..............................................................................

..........................................................................................................................56Display Button ........................................................................................................ 56Service Button ........................................................................................................ 57Clinician Menu

Config Button ......................................................................................................... 54Pwr Sav (Sleep Mode) ........................................................................................... 54Time .......................................................................................................................... 55Rotor

SpO2 Button (Models 300 and 400) .................................................................. 54

.__ 46Vitals Button (UK: All Obs) .................................................................................. 47More Button ......................................................................................................... 48...Set BP Button (UK: BP Mode) ................. . ........................................................... 48Alarms Button ......................................................................................................... 49Trend Button ............................................................................................................ 51Print Button .............................................................................................................. 53More Menu ........................................................................................................... 53...

..........................................................................................................

....Menu Tree ................................................................................................................ 46Main Menu

......................................................................................................................46

.,..,...,................,.............................................,........................, .......... 34Procedures ............................................................................................................... 36Troubleshooting ..................................................................................................... 39

Using the Menu System ...................................................... 43Introduction ............................................................................................................. 43Liquid Crystal Display ............................................................................................ 43Rotor

spa* ........ ............. .................... .. ............ ... .. . .. ...... ........

........................................................................................................21Storage ...................................................................................................................... 21

Using the Monitor ............................................................... 23Noninvasive Blood Pressure Determination ..................................................... 23Procedures ................................................................... . ........................................... 27Manual Mode ......................................................................................................... 29Auto Mode ............................................................................................................... 29Stat Mode ................................................................................................................. 30Predictive Temperature Determination ............................................................. 3 1Procedures ............................................................................................................... 32

.......................................................................................16Front Panel Controls and Indicators ................................................................... 17Switching the Monitor On and Off .................................................................... 19Liquid Crystal Display (LCD) ............................................................................... 19Using the Printer .................................................................................................... 20Installing the Paper ................................................................................................. 20Printer Alarms

t.he Monitor ........................................................................ . ... . ............... 13Rear Panel Connections.

11

Getting Started .................................................................... 13Unpacking the Monitor and Accessories ............ . ........................ . .................... 13Power Sources .......... . ............................................................................................. 13Powering

.....................................................................................................................

70Symbols

DINAMAP@ PRO Monitor.. ................................................................. 7Product Compliance ..............................................................................................

ContentsIntroduction .......................................................................... 7About the

G . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89Connection Details . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a9Host Port Connector (rear pane)) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89

.._..._....._..............................................~................... 86Appendix

86Disposal of Product Waste . . .

.._...._..... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SpOz Sensors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84Storage and Battery Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . a5Fuses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Calibration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Leak Testing . .

.._..................................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Cleaning the Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Cuff Cleaning and Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Temperature Devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

.._............................,....,..................... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

Appendix F . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*........................... 83Maintenance . . . . . . . . . .

._.............................................. . . . . . . . . . . . . . . . . . 82Packing Instructions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82Service Manuals .

_..__...._....,............................................................................................ 69Hierarchy of Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70

Appendix C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75Principles of Noninvasive Blood Pressure Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Appendix D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79Compatibility Table and Reorder Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Appendix E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.*...... 81Warranty, Service, and Spare Parts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Repairs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

:;Patient Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69System Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Failsafe Alarm

_........... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Power Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 66Environmental . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Appendix B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..*.............

.._..............__......_....... 64Mechanical

,........._,.,........,......._,._,....,..,.,......,,..........,.........,.....SpOz

,a. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .IVAC Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

.I

BP. . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

lndica tionsThe PRO Monitor is intended to monitor one patient at thebedside.

ContraindicationsThis device is not designed, sold, or intended for use exceptas indicated.

Federal law (U.S.A.) restricts this device to sale by or on theorder of a clinician.

Warningsl Do not use the PRO Monitor in the presence of

magnetic resonance imaging (MRI) devices. There

. .have been reports of sensors causing patient burnswhen operating in an MRI environment.

SpO,

All of the main operations of the PRO Monitor are easy touse. Please review the factory default settings and, whereapplicable, enter settings appropriate for your use. The“Using the Monitor” section of this manual explains how touse the Monitor in its most simple form, while the “Usingthe Menu System” section explains how to customizemeasurements by using the menu system.

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l PRO 400: BP, Pulse, Temp, and

9 PRO 100: BP and Pulse

l PRO 200: BP, Pulse, and Temp

. PRO 300: BP, Pulse, and

400, all with printers.

Gl/endoscopy, and medical/surgical units.

The PRO Monitor comes in four different models: PRO 100,200, 300, and

DC-operated monitors are primarily intended for use in hospitalacute care settings such as outpatient surgery, accident andemergency, labor and delivery,

DINAMAP@ PRO Monitors provide noninvasivedetermination of systolic blood pressure, diastolic bloodpressure, mean arterial pressure, pulse rate, temperature,and oxygen saturation. These portable AC- and

DINAMAP PRO Monitor

IntroductionAbout the

8-

l Do not use the Monitor in the presence of flammableanesthetics.

l To help prevent unintended current return paths withthe use of high frequency (HF) surgical equipment,ensure that the HF surgical neutral electrode isproperly connected.

l To avoid personal injury, do not perform any servicingunless qualified to do so.

l WARNING: These Monitors should not be used onpatients who are connected to cardiopulmonarybypass machines.

. If powering the Monitor from an external poweradapter or converter, use only Critikon-approvedpower adapters and converters.

l The Monitor does not include any user-replaceablefuses. Refer servicing to qualified service personnel.

l To reduce the risk of electric shock, do not remove thecover or the back. Refer servicing to a qualifiedservice person.

l If the accuracy of any determination reading isquestionable, first check the patient’s vital signs byalternate means and then check the PRO Monitor forproper functioning.

Cautions

l Do not use replacement batteries other than the typesupplied with the Monitor. Replacement batteries areavailable from Critikon. See Appendix D.

l The PRO Monitor is designed to conform toElectromagnetic Compatibility (EMC) standard IEC601-l -2, 1993 and will operate accurately inconjunction with other medical equipment which alsomeets this requirement. To avoid interferenceproblems affecting the Monitor, do not use theMonitor in the presence of equipment which does notconform to these specifications.

- The electromagnetic compatibility profile of the PROMonitor may change if accessories other than thosespecified for use with the PRO Monitor are used.

l Trend data are retained in the PRO Monitor when it isturned off, except when the default is overridden byselecting the Trend button under the Service menu.

IntroductionPlace the PRO Monitor on a rigid, secure surface.Monitor must only be used with mounting hardware,poles, and stands recommended by Critikon. SeeAppendix D.

The weight of the accessory basket contents shouldnot exceed 6.6 lb (3 kg).

Arrange the power cord, air hoses, and all cablescarefully so they do not constitute a hazard.

Verify calibration of BP parameter (temp and pulseoximeter do not require calibration). Ensure that thedisplay is functioning properly before operating thePRO Monitor.

Do not immerse the Monitor in water. If the Monitoris splashed with water or becomes wet, wipe itimmediately with a dry cloth.

Do not gas sterilize or autoclave.

The PRO Monitor, when used with Critikon-approvedapplied parts and accessories, is protected againstdefibrillator damage.

Notes

l Waveforms may be distorted and readings inaccuratewhen electrosurgical cautery equipment is used whilemonitoring with the PRO Monitor.

.l . ALSO EVALUATED TO IEC-601-2-30.

CC0086

This product conforms with the essential requirementsof the Medical Device Directive. Accessories withoutthe CE mark are not guaranteed to meet the EssentialRequirements of the Medical Device Directive.

10

DINAMAP@ PRO MONITORCLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIREAND MECHANICAL AND OTHER SPECIFIED HAZARDSONLY IN ACCORDANCE WITH CAN/CSA C22.2 NO.601

C us

QD

@

IPXl, degree of protection against ingress of water

l Sterilization/Disinfection, see Appendix F

I, internally powered

l Transportable

l For continuous operation

l Not suitable for use in the presence of flammableanesthetics

l Not for use in the presence of an oxygen-enrichedatmosphere (oxygen tent)

l Type BF applied parts

l

IEC 601-l :

l Class

DINAMAP@ PRO Monitor is classified in the followingcategories for compliance with

Product ComplianceThe

externat DC power connected,the green external power indicator LED (14) will light toindicate that external power is being applied and that thebattery is charging. If the battery is not inserted, the external

+5 Voutput on the host port connector.

Powering the MonitorBefore the PRO Monitor is used for the first time, thebattery should be charged in the Monitor for at least 8hours.

Refer to the illustration of the rear panel connections.Looking at the rear of the PRO Monitor, remove the batterycompartment cover. Insert the rechargeable battery into thecompartment so that the battery terminals fit into the powerclips at the bottom of the compartment. Then replace thecover. Insert the power cord plug into the mains externalpower socket (2) and plug into an AC outlet.

Refer to the illustration of the front panel controls andindicators. With mains or

auto-resetable and mounted within the Monitor. These fusesprotect the low voltage DC input, the battery, and the

Getting StartedUnpacking the Monitor and AccessoriesBefore attempting to use the PRO Monitor, take a fewminutes to become acquainted with the Monitor and itsaccessories. Unpack the items carefully, and check themagainst the contents checklist enclosed in one of theaccessory boxes. This is also a good time to check for anydamage or shortage. If there is a problem or shortage,contact Critikon.

It is recommended that all the packaging be retained, incase the Monitor must be returned for service in the future.

Power SourcesThe PRO Monitor is designed to operate from either aninternal lead-acid battery, AC mains or an IEC 601-lcompliant DC power source (see Appendix A). Forreplacement rechargeable batteries, please refer to theService section of this manual.

The Monitor contains five fuses. Two AC line input fusesare mounted internally and are replaceable only by qualifiedservice personnel. The remaining three fuses are

9 For continued safety, use only a power cord of listed typeSJT, three-conductor, min. No. 18 AWG, terminated in amedical/hospital grade attachment plug, provided withthe following cord tag: “Hospital Grade Plug.” Grounding

14

200and 500 charge/discharge cycles. When it is necessary toreplace the battery, refer to the “Compatibility Table andReorder Codes” listed in Appendix D. To ensure fullcharge cycles, replace only with a recommended battery.If the Monitor is to be stored for some time, first chargethe battery and then remove it and store it separately fromthe Monitor.

BAlTERY IS TOO LOW FORMONITOR TO FUNCTION. TURN MONITOR OFF appears.The Monitor shuts down all functions until it is turned off andthe battery is recharged or replaced. To run the Monitor onAC power, it must be powered off and then on again.

Battery charging will take place as long as the Monitor remainsconnected to an external AC power source. A battery that isfully discharged can be fully recharged in 1 hour 50 minuteswhen the Monitor is switched off or 8 hours if the Monitor isswitched on.

Notes

l To prolong the life of the battery, keep the Monitorconnected to an AC outlet whenever possible. NEVERallow the battery to become completely discharged. Afully charged battery will power the Monitor forapproximately 2 hours and should survive between

.,:

During battery-only operation, the yellow battery powerindicator LED (17) will light. When the battery becomesdischarged beyond the low battery threshold, the indicator willbegin to flash, and the Monitor will sound warning beepsevery 30 seconds. At this point, the Monitor should beconnected to an AC outlet to recharge the battery. If theMonitor continues to be used without charging the battery,the message WARNING: THE

set).When the Monitor is running on battery power, a battery iconappears in LCD area 3 (toggling with the time indicator)indicating the charge status.

power indicator LED will flash (short flash approx. every 4

Getting Startedintegrity can only be maintained when equipment isconnected to an equivalent receptacle marked “HospitalGrade.”

l Where the integrity of the external earth conductor in theinstallation or its arrangement is in doubt, the Monitor mustbe operated from its internal battery.

General Caution

Do not touch either the pin of the DC input connector (3)or the terminals within the battery compartment (1) andthe patient at the same time.

15

(15 way D-type RS-232 serial port) for use only withequipment conforming to IEC 601-1, configured tocomply with IEC 601-l-l

16

400)Pole clamp: Used to clamp monitor to pole or standData interface connector: Host communications port

200 and

53’

Rear Panel Connections

1

23

4

56

Battery compartment cover: Retains and protectsinternal batteryMains input: Used to connect to AC power supplyExternal power socket: To be used with approvedCritikon AC-DC power converter ONLYInactive temperature cable storage: Inactive temperatureprobe cable attaches here (Models

.:::::t:.l a**me*oel :gg::gp

**al ***e

400)200

and

“F display: Indicates whether temperature is beingdisplayed in degrees Celsius or Fahrenheit (Models “C

mmHg10 Temperature probe cover storage: Box of probe covers

stored here (Models 200 and 400)11 Inactive temperature probe holster: Extra temperature

probe can be stored here (Models 200 and 400)12 Temperature display: 4-digit red LED indicates measured

temperature (Models 200 and 400)13

400)9 Diastolic pressure display: 3-digit red LED indicates

measured diastolic BP in

mmHg8 Active temperature probe holster: Temperature probe

that is being used stored here (Models 200 and

3-digit red LED indicatesmeasured systolic BP in

I

16 I

17

18

Front Panel Controls and Indicators

7 Systolic pressure display:

Getting Started

15

.s>

-18

SpOz artifact indicator LED: Illuminates when motionartifact is detected (Models 300 and 400)

25 LCD (liquid crystal display): Displays all alarms, userinterface messages, and configuration options

26 Alarm silence switch: Alternately mutes and enablesaudible alarms; when pushed once after alarm sounds(silence on), switch lights to indicate that audible alarmshave been silenced for 2 minutes

27 AUTO BP key: Press to start Auto BP mode28 Light sensor: Automatically measures ambient light to set

LED display intensity29 START/STOP BP key: Press to start or stop a BP, Auto,

Stat, or Vitals determination30 Cuff connector: BP cuff hose attaches here

% (Models 300 and 400)24

3-digit red LED indicates oxygen saturationin SpOz display:

SpOz signals (Models 300 and 400)21 Rotor: Used to highlight and select items in LCD

menus; if monitor is off, pressing rotor will switchmonitor on

22 Pulse BPM display: 3-digit yellow LED shows pulse ratein beats per minute

23

SpOz pulse indicator: Yellow LED in heart symbol flashesto indicate that real-time pulse rate measurements arebeing derived from

mmHg and shows instantaneous cuffpressure during BP determination

20

3-digit red LED indicatesmeasured MAP in

SpOz sensor extension cableattaches here (Models 300 and 400)

19 Mean arterial pressure display:

SpOz sensor connector:

14 External power indicator: Green LED indicates externalpower status and battery charging status of monitor

15 Temperature probe connector: Temperature probe cableattaches here (Models 200 and 400)

16 ON/OFF switch: Controls on/off state of monitor; pushfor power on and push again for power off

17 Battery power indicator: Yellow LED indicates operationand charge status of internal battery

18

DINAMAP PRO Monitor on, push the powerON/OFF switch (16) or press the rotor (21).

As the Monitor powers up, it will run a short self-testroutine, which will flash all the indicator lights and thenbeep the warning speaker. After a few seconds the systemwill be ready for operation, as indicated by the appearanceof the main menu on the LCD (25).

To switch the Monitor off, push the power ON/OFF switch(16) again. This will terminate any measurements that maybe in progress and automatically deflate the cuff.

When the Monitor is operating on the internal battery only,battery life is enhanced by the use of the sleep mode.However, the PRO Monitor will not enter sleep mode if analarm is active. If no controls are used and nodeterminations are being made, the Monitor will enter sleepmode after a time which can be preset by the operator. AllLED displays will be blanked except for a dash in the far-leftsystolic position, and any existing readings will betransferred to the LCD, which displays the message “SleepMode Active.” Moving the rotor or pressing a key will“wake up” the Monitor.

liquid Crystal Display (LCD)

MENU AREA

Menu AreaThis area displays the name of the menu that has optionbuttons available for selection. Normal text in the menuarea appears dark on a light background, while the text of

@

To switch the

Getting StartedSwitching the Monitor On and Off

_

. Source 2: Last three BP readings

. Source 3: Error and warning messages

Note: Refer to “Display Button” in the “Using the MenuSystem” section for instructions on setting Area 2.

Area 3This area displays the time, the time lapsed since the last AutoBP determination (if in Auto BP mode), the battery icon (ifoperating on battery power, the time and battery icon toggle),and the BP and Printer modes.

Using the PrinterInstalling the PaperTurn the PRO Monitor so that the side is facing you. Whilegrasping the side of the Monitor, firmly press the notchedindentations on the printer door to open it. The printer door willpop open. With the Monitor powered on, place the roll of paperinto the compartment so that the end of the paper comes offthe top, and thread it between the two printer plates. As thepaper touches the plates, the paper will begin to auto-feed itselfinto the printer. Feeding the end of the paper strip through theslot in the door, firmly press the notched indentation on the sideof the printer door to close it. Use the paper release lever to cleara paper jam or manually feed the paper.Note: Make sure that the roll of paper is tightly wound.

SpO, plethysmograph (Models 300 and 400)

data from one of three different sources.

l Source 1:

selected buttons appears light on a dark background.Note: Some menus have six option buttons. In these cases, thereis no space available to display the menu title.

Area 2This area displays

. placed in contact with adhesives, adhesive tapes, orplasticizers such as those found in all PVC page protectors.

80%, or“C or relative

humidity over OF/38 . exposed to temperatures over 100

to direct sunlight,

DINAMAP PROheader to be printed, thereby confirming that the paper isinstalled correctly and that the printer is operational. The messagenext to “PRNT” in Area 3 of the LCD will change to “Auto” or“Manual” to identify the operating mode of the printer. Afterpower-off, the operating mode of the printer returns to theprevious user-selected setting (Auto or Manual) unless specifiedotherwise in the Print button under the Service Button.

StorageStore thermal paper in a cool, dry place. The printed strip(thermal paper recording) should not be

exposed

-No Paper” will appear in Area 2 of the LCD and an audiblealarm will sound. In addition, the message “No Paper” willappear next to “PRNT” in Area 3 of the LCD. To clear thealarm, press the rotor. The message in Area 3 of the LCD willremain until new paper is installed and the printer door isclosed. (See “Using the Menu System.“)

Installing new paper will cause the Critikon

DINAMAP@ PRO name on it. If no print isvisible on the paper, check that the paper roll has beeninstalled in the correct position (refer to diagram). To tear offthe printout, use a slight sideways action to pull the papersharply up across the serrated edge of the door.

Printer AlarmsIf the Monitor isthe printer door

switched on with no paper installed or withopen, the message “No Paper” will appear

next to “PRNT” in Area 3 of the LCD. When new paper isinstalled and the printer door is closed, the message willchange to “Manual” for Manual print or “Auto” for Auto print,depending on the status before the paper change.

If the paper runs out during a print request or if an attempt ismade to print when no paper is installed, the message “Printer

Getting StartedAny time the paper is loaded, the printer automatically prints atest strip with the

&ions

l The paper is thermally activated; therefore, do not store it in ahot place as discoloration may result.

l Use only replacement paper rolls (58 mm) from Critikon.

22

i

Ca

Note: When in doubt about long-term storage conditions, store aphotocopy of the thermal paper recording.

hF 23”

?-%

5 minutes.

Vitals (UK: All Obs) determinations are started byselecting the Vitals (UK: All Obs) button in the Mainmenu. (Refer to the “Using the Menu System” section.)Selection of this button initiates a BP determination

Blood Pressure DeterminationDescriptionThe BP parameter is included in Models 100, 200, 300, and

400. Blood pressure is monitored noninvasively in thePRO Monitor by the oscillometric method, which measuresthe amplitude of the pressure oscillations within the bloodpressure cuff. Further information about the oscillometricmethod is in Appendix C.

The PRO Monitor has four BP modes: 1. Manual,2. Auto, 3. Stat, and 4. Vitals (UK: All Obs). The mode,

which is selected by the user, is shown on the LCD (25).The BP measurements are automatic, and once the cycle is

complete the LED displays (7, 9, 19, 22) show systolicpressure, diastolic pressure, mean arterial pressure, andpulse rate.

1.

2.

3.

4.

Manual BP determinations are started by pressing theSTART/STOP BP key (29). In the Manual mode, theblood pressure is determined one time.

Auto BP determinations are started by selecting theAUTO BP key (27) or the Auto button under the Set BP(UK: BP Mode) button in the Main menu.

When Auto mode is selected, a number at the right ofthe Auto button indicates the time interval between eachreading. To change the time interval, choose the boxaround the number and turn the rotor until the desiredinterval is reached. The interval can be set between 1

and 120 minutes (1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 45, 60,90, and 120 minutes). Press the rotor to confirm thesetting.

Stat determinations are started by selecting the Statbutton under the Set BP button (UK: BP Mode) in theMain menu. In the Stat mode, the blood pressure isdetermined as many times as possible in

Using the MonitorNoninvasive

SpOz and predictive temperaturedeterminations to be monitored and recorded(depending on Monitor model). In the Vitals (UK: AllObs) mode, the blood pressure is determined one time.

Before each BP determination, the Monitor performs a test

to ensure that the cuff pressure is below a specified level.The determination is delayed until this condition is met.During the delay, the BP values are displayed as zero.

The Monitor senses the type of hose being used andautomatically uses adult/pediatric monitoring parameters orneonatal monitoring parameters, as appropriate.

Audible and visible alarms occur when a value for systolicpressure, diastolic pressure, mean arterial pressure, or pulserate is outside the selected high or low limit.

Instructions for cleaning and disinfecting BP cuffs are inAppendix F.

Genera/ Warnings

l The PRO Monitor will not measure blood pressureeffectively on patients who are experiencing seizuresor tremors.

l Arrhythmias will increase the time required by thePRO Monitor to determine a blood pressure and mayextend the time beyond the capabilities of theMonitor.

l In Manual mode, the PRO Monitor displays the resultsof the last blood pressure determination for 2 minutesor until another determination is completed. If apatient’s condition changes between onedetermination and the next, the Monitor will notdetect the change or indicate an alarm condition.

l Devices that exert pressure on tissue have beenassociated with purpura, skin avulsion, compartmentalsyndrome, ischemia and/or neuropathy. To minimizethese potential problems, especially when monitoringat frequent intervals or over extended periods of time,make sure the cuff is applied appropriately and

-24

while allowing

#5.

If it becomes necessary to move the cuff to anotherlimb, make sure the appropriate size cuff is used.

The pulse rate derived from a BP determination maydiffer from the heart rate derived from an EKGwaveform because the PRO Monitor measures actualperipheral pulses, not electrical signals orcontractions from the heart. Differences may occurbecause electrical signals at the heart occasionally fail

#l through 12-foot hose (3.66 m) is required for the

neonatal cuff sizes

(blue-green)

24-foot hose (3.66m or 7.3 m) is required on patients who require cuffsizes from infant through thigh cuffs. The teal

12- or

.

Accuracy of BP measurement depends on using a cuffof the proper size. It is essential to measure thecircumference of the limb and to select the propersize cuff. The air hoses are color-coded according tosize of the patient. The gray

.

.

dual-tube cuffs.

l Use only accessories recommended by Critikon.Failure to use recommended accessories may result ininaccurate readings. See Appendix D.

l Blood pressure cuffs should be removed from thepatient when the Monitor is powered off. If theextremity remains cuffed under these conditions or ifthe interval between blood pressure determinations isprolonged, the patient’s limb should be observedfrequently and the cuff placement site should berotated as needed.

General Cautions

. Do not apply external pressure against cuff whilemonitoring. Doing so may cause inaccurate bloodpressure values.

l Use care when placing cuff on extremity used tomonitor other patient parameters.

l The PRO Monitor is designed for use only with

Usingexamine the cuff site and

the Monitorthe limb distal to the cuff

regularly for signs of impeded blood flow.

“N99-BP FAILED” will bedisplayed.

26

mmHg).

. Several conditions may cause the BP parameter tocalculate and display only the mean arterial pressure(MAP) without a systolic and diastolic reading. Theseconditions include very low systolic and amplitudefluctuations, so an accurate calculation for these valuescan’t be made (e.g., patient in shock); too small of adifference between systolic and MAP calculations inrelationship to the difference between diastolic andMAP; or a leak has occurred in the PRO Monitor(1. Check all BP connections 2. Monitor may needcalibration and leak testing). If only the MAP value isdisplayed, the systolic and diastolic will display dashes(-) and an alarm message

+ 8 mmHg, and a

standard deviation of + 5

/AAMI Standards foraccuracy (a mean difference of inn-a-aortic values within ANSI

9 Because treatment protocols based on the patient’sblood pressure may rely on specific values and differing

measurement methods, such as auscultatory, cliniciansshould note a possible variance from values obtainedwith the PRO Monitor in planning patient caremanagement. The PRO Monitor values are based onthe oscillometric method of noninvasive blood pressuremeasurement and correspond to comparisons with

atrial fibrillation, or the use of arapid-cycling artificial ventilator), blood pressure andpulse rate readings can be erratic, and an alternatemeasuring method should be used for confirmation.

General Notes

l A patient’s vital signs may vary dramatically during theuse of cardiovascular agents such as those that raise orlower blood pressure or those that increase or decreaseheart rate.

beat-to-beat pulse amplitude varies significantly (e.g., becauseof pulsus alternans,

to produce a peripheral pulse or the patient may havepoor peripheral perfusion. Also, if a patient’s

mmHg from values forevery inch (2.54 cm) below heart level.Select appropriate cuff size. Measure patient’s limb andselect appropriately sized cuff according to size marked oncuff or cuff packaging. When cuff sizes overlap for aspecified circumference, choose the larger size cuff.Precaution: Accuracy depends on use of proper size cuff.

mmHg to values for every inch (2.54cm) above heart level. Subtract 1.80

f

Adult/Pediatric Neonate

3.

4.

If patient is standing, sitting, or inclined, ensure that cuffedlimb is supported to maintain cuff at level of patient’sheart. If cuff is not at heart level, the difference in systolicand diastolic values due to hydrostatic effect must beconsidered. Add 1.80

I

compromised.

Procedures

Using the Monitor1.

2.

Connect the end of the air hose which has quick-releaseclips to the cuff connector (30) on the front of the Monitor.Make sure that the hose is not kinked or compressed.Note: To disconnect the hose from the Monitor, squeezethe quick-release clips together and pull the plug from thecuff connector (30).Select the appropriate blood pressure measurement site.Because normative values are generally based on this siteand as a matter of convenience, the upper arm is preferred.When upper arm size or shape, the patient’s clinicalcondition, or other factors prohibit use of the upper arm,the clinician must plan patient care accordingly, taking intoaccount the patient’s cardiovascular status and the effect ofan alternative site on blood pressure values, proper cuffsize, and comfort. The figure shows the recommended sitesfor placing cuffs.Warning: Do not place the cuff on a limb being usedfor intravenous infusion or any area where circulationis compromised or has the potential to be

12.Proceed with monitoring in the Manual, Auto, Stat, orVitals (UK: All Obs) mode.

28

.Proper cuff wrapping should be snug, but should stillallow space for a finger between patient and cuff. Cuffshould not be so tight as to prevent venous returnbetween determinations.Warning: Using a cuff that is too tight will causevenous congestion and discoloration of the limb, butusing a cuff that is too loose may result in no readingsand/or inaccurate readings.

5.

6.

7.

8.

9.

Inspect cuff for damage. Replace cuff when aging,tearing, or weak closure is apparent. Do not inflatecuff when unwrapped.Precaution: Do not use cuff if structural integrity issuspect.Connect the cuff to the air hose. Thread the cuffconnectors onto the hose connectors until finger tight.Do not overtighten.Warning: It is mandatory that the appropriate hose andcuff combination be used. Any attempt to modify thehose will inhibit the Monitor from switching betweenthe neonatal and adult measurement modes.Note: In normal use, each cuff will have its own hose, soit will not usually be necessary to disconnect them. If it isnecessary to do so, carefully unscrew the cuff from thehose. Care should be taken in reconnecting the cuff to ahose, ensuring that threads of the cuff and hose are inalignment and no cross-threading occurs.Inspect patient’s limb prior to application.Precaution: Do not apply cuff to areas where skin is notintact or tissue is injured.Palpate artery and place cuff so that patient’s artery isaligned with cuff arrow marked “artery.”Squeeze all air from cuff and confirm that connection issecure and unoccluded and that tubing is not kinked.

1 O.Wrap cuff snugly around the patient’s limb. Cuff indexline must fall within the range markings. Ensure that hookand loop closures are properly engaged so that pressureis evenly distributed throughout cuff. If upper arm isused, place cuff as far proximally as possible.

11

&Z?)Auto BP determinations are started by selecting the AUTOBP key (27) or the Auto button under the Set BP button(UK: BP Mode) in the Main menu.

Selecting the AUTO BP key (27) brings up the Set BP menu(UK: BP Mode) and automatically starts an Auto BPdetermination as long as the Monitor is in Manual BP mode.If the Monitor is already in Auto BP mode, selection of theAUTO BP key (27) brings up the Set BP menu (UK: BPMode) without starting a new determination until the presettime interval has expired. Pressing the START/STOP BP keyduring a series of Auto BP determinations will cancel thedetermination in progress.

When Auto mode is selected, a number at the right of theAuto button indicates the time interval between eachreading. To change the time interval, choose the box aroundthe number and turn the rotor until the desired interval isreached. The interval can be set between 1 and 120minutes (1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 45, 60, 90, and

29

mmHg (adult) before anotherdetermination can be started. BP information will bedisplayed for 2 minutes on the LED unless anotherdetermination is started within that time frame. This appliesto Manual and Vitals (UK: All Obs) modes. After power-off,the operating mode returns to the default setting of Manual.The default setting of Manual can be overridden to return tothe previous user-selected setting (Auto or Manual) byselecting Set BP (UK: BP Mode) under the Service menu.Note: The START/STOP BP key is an on-off switch; pressingit will stop any BP determination (Manual, Auto, Stat, orVitals) that is in progress.

Auto Mode

mmHg(neonate) or 15

@To start a determination, press the START/STOP BP key (29).A normal, uninterrupted Manual cycle takes about 40seconds. The cuff pressure must drop below 5

Using the MonitorManual Mode

t;

mmHg. Artifact rejection is relaxed in the Stat mode foradult/pediatric patients to allow for accelerateddeterminations. If a BP or Stat reading has been madepreviously, the first new systolic value will flash on the LED

display (7) within a few seconds and will continue to flashuntil the end of the determination. At that point a short tonewill sound and the updated systolic, diastolic, and mean

30

mmHg for adult/pediatrics.The initial target pressure selection for neonates is 110

20 seconds. Selecting theStat button during a series of Stat determinations will cancelthe determination in progress and the rest of the series. BPinformation will be displayed on the LED until thedetermination has been canceled or completed. This appliesto Stat mode only.

The series begins with cuff inflation to a pressure above theprevious systolic pressure or, if no previous systolic value isstored, to approximately 160

15 to

mmHg (adult) for at least 30 secondsbefore another determination can be started. BPinformation will be displayed on the LED until the nextdetermination is started. This applies to Auto mode only.Note: To cancel an Auto BP determination, select theManual button in the Set BP menu (UK: BP Mode).

Stat ModeMultiple BP readings can be taken at any time by selectingthe Stat button under the Set BP button (UK: BP Mode) inthe Main menu. Stat mode can also be accessed bypressing the AUTO BP key (27) and then selecting the Statbutton when the Set BP menu (UK: BP Mode) appears.

If a Manual determination is not in progress, a S-minuteseries of determinations will start. If a Manual determinationis in progress, that determination will become the first in theseries. A normal, uninterrupted Stat sequence will give thefirst set of systolic, diastolic, and mean arterial pressurevalues and pulse rate within

mmHg(neonate) or 15

120 minutes). Press the rotor to confirm the setting. Afterpower-off, the operating mode returns to the default settingof Manual. The default setting of Manual can be overriddento return to the previous user-selected setting (Auto orManual) by selecting Set BP (UK: BP Mode) under theService menu.

In the Auto mode, the pressure must be below 5

Alaris Medical Systems*IVAC is a trademark of

“F display (13). The default, which isCelsius, can be changed in the Clinician Menu (please referto the “Using the Menu System” section of this manual).

“C

comms.

During a temperature determination, the temperaturedisplay (12) provides a progress meter and probe readyindicator. In the far-left position, a single horizontal lineindicates the probe is ready to start a determination afterremoval from the probe holster. In the far-right position ofthe temperature display, a “chase sequence” around theoutside space indicates a predictive temperaturedetermination is in progress. During monitor mode, thetemperature readings flash constantly.

Temperature is shown on the temperature display indegrees Celsius or Fahrenheit, and the unit of measure isindicated by the

IVAC* technology and can beused with both oral and rectal temperature probes. Twomodes of operation are available: predictive and monitor.In predictive mode, a final temperature is displayed with anaudible tone. In monitor mode, the display is updatedcontinually as the patient’s temperature rises or falls.Note: If the PRO is unable to complete a predictivedetermination, then it enters monitor mode. Thesetemperature readings are not stored in trends and notreported via host

QDescriptionThe temperature parameter is included in Models 200 and400. The PRO Monitor uses

five Tempera ture De termina tionPredic

mmHg for 4 seconds (adults),unless the S-minute period has ended or the determination

has been canceled.Note: Alarm limits are disabled while in Stat mode.

mmHg for 8seconds (neonates) or 15

Using the Monitorarterial pressures and pulse rate will appear on their LEDdisplays (7, 9, 19, 22). The Monitor will begin anotherdetermination once the pressure is below 5

Alaris Medical Systems

32

*IVAC is a trademark of

IVAC probes and probe covers are used.

Procedures1.

2.

3.

Connect the temperature probe cable to thetemperature probe connector (15).Remove the temperature probe from the probe holster.Place a protective temperature probe cover on theprobe and insert the probe appropriately.The determination begins automatically. Hold thetemperature probe steady until the determination iscomplete. This takes approximately 60 seconds, duringwhich time a pattern of lines on the temperature display(12) appears as a “chase sequence” to indicate progress.

IVAC* probes and probe covers. The size,shape, and thermal characteristics of the probe coverscan affect the performance of the instrument.Inaccurate readings or retention problems may occurunless

5 seconds for theprobe tip to cool before proceeding.

l Use only

OC.

l Accurate rectal temperatures can only be obtained byusing the red temperature probe. Red and bluetemperature probes are not interchangeable.

l Do not allow the tip of the predictive temperatureprobe to come into contact with a heat source (e.g.,hands or fingers) prior to taking a temperaturedetermination. If this occurs, allow

OF or1

General Warningl The performance of the Monitor may be degraded if it

is operated outside of the environmental conditionsspecified in Appendix A.

General Cautionsl Be careful not to overextend the coiled cord of the

temperature probe. Overextension can damage theprobe coil connector interfaces.

l Accurate oral temperatures (blue) can only beobtained by placing the probe under the tongue in theright or left sublingual pocket. Temperatures in otherlocations in the mouth can vary by more than 2

- If an alarm is actively sounding, an audible tone will notsound.

l If tissue contact is lost, the chase sequence on thetemperature display (12) stops. If tissue contact is notmade within 1 minute, the Monitor will alarm.

Th.e Monitorwill not beep at final temperature. It will continue tomonitor the patient’s temperature until the probe isremoved from the patient and returned to the probeholster.

l To cool the temperature probe down, wipe with alcohol.l If there is a long delay from the time the probe is

removed from the probe holster until it is inserted intothe patient’s mouth, it is possible that the instrument willnot display a final temperature. If this occurs, insert theprobe into the probe holster, remove it again, and start anew measurement.

(34.4” C) when taken out of the probe holster, the

thermometer will not be able to perform a predictivemeasurement. Instead, the thermometer willautomatically go into monitor mode. The temperaturereading will then flash. A correct final temperaturereading may require 3 minutes or longer.

4.

Using the MonitorWhen the determination is complete, an audible tonesounds and the temperature appears on the display.Record the temperature and remove the probe. Discardthe disposable cover by holding the probe as you woulda syringe and pressing the button on the probe handle.

Place the probe in the probe holster. Once you place theprobe in the probe holster, the temperature values willbe cleared.

Notesl If the probe tip temperature is 94.0” F or higher

Inc.

34

SpOz. Refer to “Alarms Button” in the “Using the MenuSystem” section.

*NELLCOR is a trademark of Mallinckrodt,

SpOz: levels areoutside the alarm limits. When a limit alarm occurs, amessage appears in Area 2 of the LCD display.

If you select the Alarms button, the Alarms menu appears.This menu is used to adjust the violation limits for BP and

SpOZ saturation level. The pitch ishighest at 100% oxygen saturation, and it becomes lower asthe saturation level falls. The Monitor can display a pulseamplitude bar and a plethysmographic waveform on theLCD (25). The pulse amplitude bar graph is proportional tothe arterial blood flow. The artifact indicator LED (24) lightscontinuously when the Monitor detects motion sufficientenough to affect readings.

Audible and visible alarms occur when

SpOz signal. A tone sounds at a

rate corresponding to the pulse rate and at a pitch

corresponding to the

SpOz pulse indicator (20) flashessynchronization with the real-time pulse rate measurementsthat are derived from the

(22), and the Sp02 appears in the Pulse BPM

display

(23), which is continually updated.

Heart rate derived from

SpOz display

SpOz is the ratio of oxygenatedhemoglobin to hemoglobin that is capable of transportingoxygen. This ratio, expressed as a percentage, is shown onthe

(SpOJ of arterial blood isnoninvasively and continuously monitored in thePRO Monitor using pulse oximetry technology fromNELLCOR*. Functional

SpOZ sensor onthe patient’s finger; monitoring begins automatically.Functional oxygen saturation

SpOz monitoring, simply place the SpOz parameter is included in Models 300 and 400. To

begin

spa,DescriptionThe

SpOZmeasurement.

General Cautions

l As with any clip-on sensor, pressure is exerted. Theclinician should be cautious in using a clip-on sensor on

SpOZ function is calibrated to read functionalarterial oxygen saturation. Significant levels ofdysfunctional hemoglobins such as carboxyhemoglobinor methemoglobin may affect the accuracy of the

SpOZ measurement.

l The

SpOZ measurements.Always remove oximetry devices and attachments fromthe MRI environment before scanning a patient.

l The use of cardio-green and other intravascular dyes atcertain concentrations may affect the accuracy of the

SpOZ function during magneticresonance imaging (MRI). Adverse reactions includepotential burns to patients as a result of contact withattachments heated by the MRI radio frequency pulse,potential degradation of the magnetic resonance image,and potential reduced accuracy of

SpOz reporting of values when several consecutivegood pulse determinations are made.

Genera/ Warningsl Do not use the

SpOz monitoring, the values in the LED flash,alternating patient values with dashes. The Monitor returns tonormal

ICancel

If the Monitor is unable to detect a pulse for 10 secondsduring normal

SpOz is suspending

2:oo

Sp02.

Low

SpOZ alarm suspension andreturn to monitoring

Sp02 alarm suspend is counting down.Selecting Cancel will cancel the

SpOzLED while the

Sp02 issuspending appears in Area 2 and dashes appear in the

SpOzmonitoring. A message informing the user that

SpOz alarm is suspendedfor 2 minutes and then the PRO returns to normal

Using the MonitorIf you select the Suspend button, the

0X6-OJXUK

Phone: 44-189-632-2700

1

Phone: 1-800-NELLCOR (USA) Fax: l-888-222-9799

UK Nellcor10 Talisman Business CenterLondon RoadBicesterOxfordshire

MacDonnell BlvdPO Box 5840St. Louis, MO 63 134

_,

Procedures1. Select a sensor that is appropriate for the patient and the

clinical situation.Warning: Do not use a damaged sensor or one withexposed electrical contacts.Note: Use only NELLCOR sensors, which are availablefrom:

USA Mallinckrodt, Inc.675

,

. A patient’s vital signs may vary dramatically during the use ofcardiovascular agents such as those that raise or lower bloodpressure or those that increase or decrease heart rate.

l The PRO Monitor is compatible only with NELLCOR sensors.

l Software development, software validation, and Risk andHazard Analysis has been performed to a registered qualitysystem.

.

>T

General Notes

SpOZ function. To preventsuch interference, cover the sensor with opaque material.

_,lights, direct sunlight, operating room lights) may interferewith the performance of the

. Bright light sources (e.g., infrared heat lamps, bilirubin

I

patients with compromised circulation (e.g., because ofperipheral vascular disease or vasoconstrictingmedications).

l Do not perform any testing or maintenance on a sensorwhile it is being used to monitor a patient.

SpOZ.

37

SpO, sensor to the limb opposite the one with theblood pressure cuff.

Remove nail polish and artificial nails. Placing a sensoron a polished or an artificial nail may affect accuracy.

CautionsPatient safety:

Do not place any clip-on sensor in a patient’s mouthor on a patient’s nose or toe.

Do not place a clip-on finger sensor on a patient’sthumb or across a child’s foot or hand.

Observe the sensor site to assure adequate distalcirculation.

Monitor performance:

l For best performance, place the sensor at heart level.

l Placing a sensor distal to an arterial line may interferewith adequate arterial pulsation and compromise themeasurement of

SpOZ readings are requiredduring the entire blood pressure determination, attachthe

SpOZ data will not be valid whenthe cuff is inflated. If

SpOZ sensor is on a limb that has a bloodpressure cuff, the

2

Using the MonitorFollowing the directions for use supplied with the sensor,apply the sensor to the patient.

WarningsPatient safety:

If you fail to apply the sensor properly, the patient’sskin could be injured or the ability of the PROMonitor to measure oxygen saturation could becompromised, For example, a clip-on sensor shouldnever be taped shut. Taping the sensor could damagethe patient’s skin or impair the venous return, thuscausing venous pulsation and inaccuratemeasurement of oxygen saturation.

Excessive pressure from the sensor may cause necrosisof the skin.

Monitor performance:

When an

SpOz determinations runcontinuously and can run simultaneously with othermeasurements.

38

SpOzsensor connector (18).

Proceed with monitoring.

SpOZ sensor extension cable into the Sp02 sensor extension cable.

Then plug the SpOz sensor into the

.;

Plug the

LEDs and the photodiode areopposite each other.

,l Place the sensor so that the

3.

4.

. .

LI

39i”

Y-

SpOz function to find a pulse pattern.

l An electrosurgical unit (ESU) may be interfering withperformance.

SOLUTION:

Check the patient.

l If possible, keep the patient still; check whether the sensor isapplied securely and properly, and replace it if necessary;move the sensor to a new site; use a sensor that tolerates moremotion.

. Excessive patient motion may be making it impossible for the

SpO2 value or the pulse rate changes rapidly; thepuise amplitude bar is erratic.CAUSE:

SpOzsensor is applied securely and properly, and replace it ifnecessary; move the sensor to a new site; or use a disposableadhesive sensor that may tolerate more motion.

l Replace the sensor.

PROBLEM: The

SpOzfunction to measure saturation and pulse rate.

SOLUTION:Check the patient.

l If possible, keep the patient still; check whether the

SpOz function to find a pulse pattern.

l The sensor may be damaged.

it impossible for the

l The patient’s perfusion may be too low to allow the

Using the MonitorTroubleshootingThis section discusses potential difficulties and suggestions forresolving them. If the difficulty persists, contact a qualified serviceperson or your local Critikon representative.

The service manual, which is for use by qualified service personnelprovides additional troubleshooting information.

PROBLEM: The pulse amplitude bar indicates a pulse, but nooxygen saturation or pulse rate values appear on the screen.CAUSE:

l Excessive patient motion may be making

-40

2,3-DPG.

l Accuracy can be affected by incorrect sensor application oruse; intravascular dyes; bright light; excessive patientmovement; venous pulsations; electrosurgical interference;and placement of a sensor on an extremity that has a bloodpressure cuff, arterial catheter, or intravascular line.

SOLUTION:

l Check that calculations have been corrected appropriately forthe relevant variable. In general, calculated saturation valuesare not as reliable as direct laboratory hemoximetermeasurements.

l If there is excessive light, cover the sensor with opaquematerial.

l Circulation distal to the sensor site should be checkedroutinely. The site must be inspected every 8 hours to ensureadhesion, skin integrity, and correct optical alignment. If skinintegrity changes, move the sensor to another site.

CO,; fetal hemoglobin; or pH; temperature; Sp02 calculation may not have correctly adjusted for the

effects of

OXISENSOR N-25 oxygen transducer to an appropriatesite. This sensor has added protection against electrosurgicalinterference.

PROBLEM: The oxygen saturation measurement does notcorrelate with the value calculated from a blood gasdetermination.CAUSE:

l The

0 The sensor may be damp or may need to be replaced with anew sensor.

l If the patient weighs less than 3 kg or more than 40 kg, applyan

SpOz cable as far from the ESU as possible.

l Plug the Monitor and the ESU into different AC circuits.

l Move the ESU ground pad as close to the surgical site aspossible.

ESU is interfering:

l Move the

If an

SpO2 signal was present but has disappeared.CAUSE:

l A BP determination on the same limb is in progress.

SOLUTION:

l An alarm message (No signal) will appear on the screen, and theaudible alarm will sound immediately.

PROBLEM: A bad signal error has occurred.

CAUSE:

l Weak or “noisy” signal.


. If possible, keep the patient still; check whether the sensor isapplied securely and properly, and replace it if necessary; movethe sensor to a new site; or replace the sensor.

l Change sensor type.

l Consider increasing perfusion using heat.

l If there is excessive light, cover the sensor with opaque material.

PROBLEM: A sensor error indicating a bad sensor has occurred.CAUSE:

l The sensor or cable may be defective, or the cabling may beimproperly connected.


l If possible, keep the patient still; check whether the sensor/cableis applied securely and properly, and replace it if necessary.

l Disconnect and reconnect the sensor.

41

l Try to keep the patient still, or change the sensor site to one withless motion.

l Observe all instructions, warnings, and cautions in this manualand in the directions for use of the sensor.

PROBLEM: A valid

1

second. This delay on the LCD does not affect theperformance of the Monitor.

10” C),updates on the LCD can be delayed by approximately

/ OF

Sp02 data and error and warningmessages. The Display mode menu is used to select thedata to be displayed.

Area 3This area displays the time, the time lapsed since the lastAuto BP determination (if in Auto BP mode), the batteryicon (if operating on battery power, the time and batteryicon toggle), and the BP and printer modes.Note: In cold ambient temperatures (below 50

L Using the Menu SystemIntroductionThe PRO Monitor is equipped with a liquid crystal display(25) and a rotor (21). Used together, these allow theoperator to view and edit most of the Monitor’s parametersand functions. When the Monitor is in use, a number ofoption buttons appear on the liquid crystal display (LCD).The model of the Monitor determines which menu optionbuttons appear on the LCD. The number of buttons and thespecific options depend on the menu level. The rotorprovides the means of choosing menu options andchanging monitor settings.

Liquid Crystal DisplayThe LCD is divided into three areas, each of whichdistinct function.

has a

MENU AREA

AREA 3

Menu AreaThis area displays the menu buttons that are available forselection. Normal text in the menu area appears dark on alight background, while the text of selected buttons appearslight on a dark background.

Area 2This area displays BP and

.._r .,

r’

-- - -- - __ -- _ __ _ . _ _ ,,:S2 + -- - -- - -- _ __ _ __ _ __ _ ,,:q

__- --- ---__- ,,:a2 ___ ___ c -_- --- ---_-- -__ ,I:37 ___

SpO2 TEMPTIME SYS DIA MAP BPM

L

POWER SAVE MENU

SYS DIA MAP BPM

Display

11 Main 1 1 Stat )

”

Menu Tree

Yew

Notesl The model of the Monitor determines which menu option buttons appear on the LCD.

45

Set Day Mon

24-Aug-1999

How Min

pi-,, 20: 21 11

I

Clear Trend on Power-up?

Restore Print mode on power-up?

Restore BP mode on power-up?

Enter alarm configuration mode?

I999

.

Automaticalley

14-J&

_ Using the Menu SystemMenu Tree

ROTOR BEEPI

a// possiblechoices available within the menu structure, from the toplevel downward.

Main MenuThis menu is the top level menu. It is displayed when theMonitor is first switched on and after the rotor has beeninactive for 2 minutes, unless the Monitor is in sleep mode(Pwr Sav).

46

RotorRotating the rotor causes option buttons to be highlighted(light text on a dark background). Turning the rotorproduces a click. Turning it clockwise moves thehighlighting clockwise over the available buttons, whileturning it counterclockwise reverses the direction of the

highlighting. Pressing the rotor selects the highlightedbutton and produces an audible tone.

Some menus (e.g., Alarms) contain values that can bechanged by the operator. After the value is highlighted, theuser selects it by pressing the rotor. Turning the rotorclockwise will cause the value to increase, and turning therotor counterclockwise will cause the value to decrease.Pressing the rotor again will confirm the changed value.

Menu TreeThe menu tree on the previous page shows

SpO,values are also retained the same manner asthe BP and Temperature values.

PrintSelection of this button causes the current data to be printed.

SpO, plethysmograph is displayed on the LCD,

the waveform pauses for 2 minutes or until the Clear button isselected.

SpO, monitoring andalarms are suspended.

ClearSelection of this button halts measurements and returns theuser to the Main menu.Note: If the

LEDs andheld for 2 minutes or until cleared by the user. The LCDshows:

Values Held

Note: If the printer is in “Auto”mode, the Print button does notappear as an option.

Notes

l If the Monitor is performing a Vitals determination, theVitals button cannot be selected.

l If a BP determination is in progress, the Vitals button

cannot be selected.

l A Vitals determination is canceled if the BP determination

is canceled.

. A Vitals determination can be canceled by pressing eitherthe AUTO BP or START/STOP key.

l During the 2 minute freeze period,

SpO, and predictive temperature determinations tobe monitored and recorded (depending on Monitor model).

When the Vitals determination is complete, a single “warble”sounds and all patient data are displayed on the

- Using the Menu SystemVitals Button (UK: All Obs)Selection of this button initiates a BP determination whileallowing

-48

Notes

l The Print button appears only when Print is set to Manualmode.

. If the printer is in Auto print mode, the data will be printed

automatically.

More... ButtonSelection of this button displays the More... menu. The More...menu has six options (depending on model of Monitor), most ofwhich have submenus. For this reason, instructions for the More...button are in a separate section.

Set BP Button (UK: BP Mode)Selection of this button displays the Auto, Stat, and Manual BP menu.

Auto BPManualTgt Pressure

AutoSelection of this option starts an Auto BP determination. WhenAuto Mode is selected, a number at the right of the Auto buttonindicates the time interval between each reading. To change thetime interval, choose the box around the number and turn therotor until the desired interval is reached. The interval can be setbetween 1 and 120 minutes (1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 45,60, 90, and 120 minutes). Press the rotor to confirm the setting.After power-off, the operating mode returns to the default settingof Manual. The default setting of Manual can be overridden toreturn to the previous user-selected setting (Auto or Manual) byselecting Set BP under the Service menu. To cancel an Auto BPdetermination, select the Manual button in the Set BP (UK: BPMode) menu.

ManualSelection of this option starts a Manual BP determination. Afterpower-off, the operating mode returns to the default setting ofManual. The default setting of Manual can be overridden toreturn to the previous user-selected setting (Auto or Manual) byselecting Set BP under the Service menu.

SpO,. The values and ranges for these parameters arenot stored when the Monitor is turned off. The user mayedit the limits, but they are restored to the default valueseach time the Monitor is switched on. To permanentlychange the alarm limits, refer to “Alarms” under “ServiceButton” in the “Using the Menu System” section.

5 minutes.Note: Alarm limits are disabled while in Stat mode.

MainSelection of this button returns the user to the Main menu.

Alarms ButtonSelection of this button displays the Alarms menu. Thismenu is used to adjust the violation limits for BP, Pulse Rate,and

stat

Selection of this option allows the user to start Statdeterminations. When Stat is selected, blood pressure isdetermined as many times as possible in

mmHg, then that settingis the target pressure that will be used. When the targetpressure is changed, the next determination will use the newtarget inflation value if no systolic is available. Initial targetpressure is restored to the factory default setting afterpower-off. The target pressure can be adjusted permanentlyin the Clinician menu of the Service mode (refer to “Press”in the “Using the Menu System” section).

mmHg. If the targetpressure is set between 100 and 140

mmHg underthe Set BP or Clinical menu, the Monitor automaticallydefaults to a target pressure of 110

mmHg for adults and 110 forneonates. (This is indicated by “AUTO” at the end ofadjustable range.) When using a neonate blood pressure cuff,if the target pressure is set to greater than 140

mmHg increments. Thefactory default is 160

mmHg in 5

Tgt PressureSelection of this option allows the user to set the BP targetinflation pressure. The initial target pressure can be setbetween 100 and 250

B Using the Menu System

_>

50

IL,

_,I

A.

J

,.

I

AutoSelection of this button updates the alarm limits on the LCDrelative to the current parameter values. Pressing this buttonwill automatically cancel any limit violation alarm thatbecomes invalid as a result of a limit change. Alarm limitsare updated as follows:

I Main

- 99 90

VolumeSelection of this button displays the alarm volume submenu.The volume range is from 1 to 10, with 10 being theloudest. The alarm volume is stored when the Monitor isturned off and restored to the user’s preference each timethe Monitor is switched on. Selection of the Check buttonallows the current volume setting to be heard. Selection ofthe Main button returns the user to the Main menu.

ALARM VOLUME

’ Offspo2 Low 50 SpO2 High 51-100

I 40- 245Lo\ 30 L Heart Rate

I- 195j 30

15 - 240

_--30

___. _._----

180.._.. . . . 245-.-~..- _ 35 --

/Range Default---

Hiah/

Diastolic

,Systolic Low

/I

Systolic High

1

Parameter

1 Auto KlFF

cl90

spozSYS DIA MAP

cl130

cl140

cl15

cl50

BPM

I

DisplaySelection of this button allows the operator to view thetrend data.Note: If the trend data have been lost (e.g., if the clocksettings have been changed), the message “Trend Empty”

will appear instead of the Newer, Older, and Print pagebuttons.

I Print All

11 Clear 1 ( Display

. In no case will the updated alarm limits be set beyondthe valid limits in the preceding table.

l If no values are available, the limits will remainunchanged.

MainSelection of this

Trend ButtonSelection of this

button returns the user to the Main menu.

button displays the Trend mode menu.

), the valid range of measurement becomes the limits.

Notes

+5is greater than 100%

SpO2 * If the reading plus the limit is greater than the valid range of measurement (e.g.,

+5* spo2 -5spo2 spanspan

+30 BPM -30+30 MAP -30

Heart Rate BPM BPM

+30 DIA -30

MAP MAP MAP DIA

SYS -30Diastolic DIA

+30SYS SYSj 1 Label High Limit Low Limit

Systolic

I Using the Menu System

1

Parameter Label

;;

oaae. Selection of this button causes the displayedinformation to be printed. If no information is available, thisbutton will not appear.

Main. Selection of this button returns the user to the Mainmenu.

ClearSelection of this button produces an advisory that the trendwill be lost. Choosing Yes will erase the trend memory.Choosing No will retain the trend memory. This buttondisappears from the menu while printing and when Trend isempty.

Print AllSelection of this button prints all the historical data available.When selected, this button temporarily changes to Canceluntil the history has completed printing. Once printing iscomplete, the Cancel button returns back to the Print Allbutton. This button disappears from the menu when Trendis empty.


52

and Older. These buttons may be used to moveforward and backward through the recorded data. If noinformation is available, these buttons will not appear.

Print

-

Newer

- - _- _ __ - __ - __ _ __ _ 11:52 II:47 ___ ___ ___ ___ ___ ___11~42 ___ ___ ___ ___ ___ ___II:37 ___ ___ ___ ___ ___ ___

SpO2 TEMPTIME SYS DIA MAP BPM

1 Using the Menu SystemPrint ButtonSelection of this button displays the Print menu.

PRINT MENU

Auto/ManPressing this button toggles between Automatic and ManualPrinting modes. The current mode is displayed on Area 3 ofthe LCD. The Automatic mode prints the readings after eachdetermination. The Manual mode, which is the factorydefault mode, requires the user to press the Now button toprint the readings.

NowSelection of this button causes the last readings of theavailable parameters to be printed. If no readings areavailable, the message “No reading” is printed for thatparameter. An error message appears if there is no paper inthe printer.

His torySelection of this button causes the entire contents of thetrend memory to be printed. When selected, this buttontemporarily changes to Cancel until the history hascompleted printing.


More... MenuThis menu is used to set the various operating modes of theMonitor.

LEDs). Sleep mode is available only if the Monitor isoperating from its battery. Sleep mode conserves powerwhile the Monitor is not in use. Once the Monitor is inSleep mode, the user can return it to normal operation bytouching any button or the rotor.

54

(LEDs blanked and LCD displaying valuesfrom

I

Pwr Sav (Sleep Mode)Selection of this button allows the operator to specify thetime, in minutes, that elapses before the Monitor goes into“sleep” mode

I Main

tI Rotor

Save mode and time to be adjusted.Config mode menu,

which allows the Power

Config ButtonSelection of this button

returns the user to the Main menu.

displays the

1

VolumeThe pulse tone volume can be set in the range of Off to 9.The value Off should be selected if no pulse tone is desired.The volume setting is stored when the Monitor is turned offand is restored to the user’s preference each time theMonitor is switched on.

MainSelection of this button

[ Main

5

SpOZ pulse tone volume.

Volume

SpOz mode menu,which is used to set the

SpO, Button (Models 300 and 400)Selection of this button displays the

I-*,L. 55P

dd/mmm/yyyy; however, to avoid confusion the month numberhas been substituted with a three-letter abbreviation. Leapyears are calculated automatically.

2Qhour format. The date is in the British format of

comm

TimeSelection of this button allows the operator to change theinternal time and date of the Monitor. The clock, which ismaintained by an internal battery after power down, uses

SpO, signal is detected

A BP determination is started through the host

SpO, is not actively reporting patient statistics

The keys and rotor have not been used for the presettime

The Monitor is running from its battery

No determinations are in progress

The Monitor has been running from the battery for theentire preset time

following occur:

The rotor is turned or pressed

Any of the keys are pressed

An alarm condition is issued

The battery supply level becomes discharged to acritical level

A mains or suitable DC supply is connected

An Auto BP or Temp determination starts

An

.

The Monitor awakens from Sleep mode if any of the

Monitor enters Sleep mode only if the following are true:

No alarm is active

.

.

-

POWER SAVE MENU

The

C Using the Menu System

Sp02 data are available) and anyerror or warning messages that may appear. The Displaymode setting is maintained when the Monitor is switchedoff and on.

NIBP isselected, Area 2 of the LCD will remain blank except for thepulse amplitude bar (if

SpO, nor 3 SpO, or BP data. If neither

1


Display ButtonSelection of this button displays the Display mode menu.This menu is used to specify whether Area 2 of the LCD willdisplay

1 Main

dmenu.

RotorSelection of this button displays a panel for setting thevolume of the beep that sounds when the rotor is turned.The range of adjustment is Off (default) to 9, and the settingis retained when the Monitor is turned off.

ROTOR BEEPVolume 3

,

Main Selection of this button returns the user to the Main

,_

Accept. Selection of this button produces an advisory to theuser that the trend will be lost when the clock settings arechanged. Choosing Yes will cause the Monitor to accept thenew clock settings and erase the trend memory. ChoosingNo will cause the Monitor to retain the existing clocksettings and the trend memory. Either choice returns theuser to the Main menu.

1, ,Year , Mon , , , Day , Set , Min , , 1 , Hour,

24-Aug-1999: 21 11

.;

20

SpO2 is automatically disabled when entering Servicemode.

l Service modes that affect the calibration or alignmentof the instrument are not available to the user. Thesemodes are described in the Service Manual.

Sp0~ data is available, the pulse amplitudebar will also be displayed.


Service ButtonSelection of this button displays a keypad that allows theclinician to access some parts of the Service mode menu.To access the Clinician menu, use the rotor to select thenumbers 1, 2, 3, 4 sequentially.

Notes

l

NIBP readings willbe displayed. If

N/BPWhen this option is checked, the last 3

SpO;! data are available,the plethysmograph waveform and the pulse amplitude barwill be displayed.

3

SpOz PlethWhen this option is checked and

i4X 4 SpO2 Pleth

Using the Menu System

“F indicator lights.

58

“C indicator lights. WhenF (Fahrenheit) is selected, the

i

OK. Selection of this button returns the user to the Clinicianmenu.

Temp. Selection of this button displays the temperaturesubmenu, which allows the user to choose the temperaturelabel. When C (Celsius) is selected, the

mmHgfor adults and 110 for neonates. This is indicated by the “AUTO”label at the end of the adjustable range. When the target pressureis changed, the next determination will use the new target inflationvalue if no systolic is available. When adjusted under the Clinicianmenu of the Service mode, the target pressure is adjustedpermanently.

TARGET PRESSURE

Default 100

mmHg increments. The factory default is 160 mmHg in 5

..,

The initial target pressure can be set between 100 and 180

-i

_.A

.r’

_I

i

.>I

___*’

*

mmHg, and the setting isretained when the Monitor is turned off.

mmHg to 180

Clinician Menu

Press. Selection of this button displays a panel for setting thedefault BP target inflation pressure. Adjusting the default targetpressure will automatically update the current inflation targetpressure and will be used for the next reading. The range ofadjustment is 100

NIBP system to be displayed. Selection of OK returnsthe user to the Clinician menu.

Last Calibration

NIBP 14-Jul-1999

OK. Selection of this button returns the user to the Clinician menu.

More.... Selection of this button displays the More... menu, whichallows the user to permanently change default mode settings.

TREND WILL BE LOST

OK. Selection of this button returns the user to the Clinician menu.

Info. Selection of this button causes the most recent calibration

date of the

F. Selection of this button toggles the temperature displaybetween Celsius and Fahrenheit and produces an advisory that thetrend will be lost. Choosing Yes will cause the Monitor to acceptthe new temperature label and erase the trend memory. ChoosingNo will cause the Monitor to retain the existing temperature labeland the trend memory.

t

C or

OK I

Using the Menu System

_.

SYS DIA MAP BPM

60

Trend. Selection of this button displays the message:Automatically clear trend on power-up? Selection of Yesoverrides the default setting by clearing all trends on power-up andreturns the Monitor to the More... menu. Selection of No retainsthe default setting by saving all trends after power-off and returnsthe Monitor to the More... menu. Selection of Cancel returns theuser to the More... menu.

Print. Selection of this button displays the message: Restore Printmode on power-up? Selection of Yes restores the Print mode tothe default setting (previous user-selected mode) after power-offand returns the Monitor to the More... menu. Selection of Norestores the Print mode to the Manual mode after power-off andreturns the Monitor to the More... menu. Selection of Cancelreturns the Monitor to the More... menu.

Set BP. Selection of this button displays the message: Restore BPmode on power-up? Selection of Yes restores the BP mode toprevious user-selected mode after power-off and returns theMonitor to the More... menu. Selection of No restores the BPmode to the default setting of Manual after power-off and returnsthe Monitor to the More... menu. Selection of Cancel returns theMonitor to the More... menu.

A/arms. Selection of this button displays the message: Enter alarmconfiguration mode? Selection of No returns the Monitor to theMore... menu. Selection of Yes brings up the Alarms menu.Selection of Reset changes all alarm limits back to the factorydefaults and returns the Monitor to the More... menu. Selection ofSave permanently saves the user-selected alarm limits and returnsthe Monitor to the More... menu. Selection of Cancel returns theMonitor to the More... menu.

-*

button (26) is

the Main menu.

k Using the Menu SystemMain. Selection of this button returns the user to the Main menu.

Silence. Selection of this button will cause all alarms except theFAILSAFE alarm to be muted. A confirmation menu will appear inArea 2 of the LED. Selection of either Yes or No returns the user to

the Clinician mode menu. If silence is confirmed, the Alarm Silencebutton (26) illuminates and alarms are permanently muted. Ifsilence is not confirmed, the alarm will be audible.Caution: Alarms will be muted until either the Monitor isswitched off and on again or the Alarm Silencepressed.

Confirm silence

Main Selection of this button returns the user to

i

62

.i

OK ButtonSelection of this button acknowledges the error. The Monitorclears the identified error and then returns the user to the Mainmenu.

.I

Alarm conditions are addressed in two ways: the Alarms buttonand OK button.

Alarms ButtonSelection of this button takes the user to the Alarms menu,where the alarm limits can be adjusted. This button is availableonly when a parameter alarm limit has been violated.

Lpi-1j

,’

,

HIGH SYSTOLIC

_Error and Warning MessagesThe error panel appears in Area 2 of the LCD and indicates theerror and its code, if it has one. In this example, a limit violationalarm (which has no error code) has occurred. A list of alarmerror messages and their codes is in Appendix B.

ALARIS Medical Systems*IVAC is a trademark of

I!I 3.5%

“Fahrenheit (F)“Celsius (C)

Max: 42.2’ C; 108.0” F

Min: 3 1.6” C; 88.9” F

200 beats/min (neonate)30 to beats/min (adult)200 30 to

mmHg (neonate)mmHg (adult)

150 to 165

mmHg)

120 s (adult)85 s (neonate)

300 to 330

mmHg,standard deviation 18

<5

AAMI standard SP-10(mean error

TemoeraturqScale

RangePredictive mode

Meets or exceeds ANSI/

IVAC*

30-245 15-215 10 -195Neonate 40-140 30-115 20 -100

Blood Pressure Accuracy

Maximum Determination Time

Overpressure Cutoff

Pulse Rate Range

Pulse Rate Accuracy

(mmHg) Systolic MAP DiastolicAdult

mmHg (neonate)

Blood Pressure MeasurementRange

mmHg (adult)100 to 140

mmHg (neonate)

100 to 250

+ 15 mmHg (adult)

110f 15

mmHg (neonate)

160

mmHg (adult)0 to 140

mmHg increments)

Appendix A

0 to 290 HzCuff Pressure Range(Normal operating range)

Default Target: Cuff Inflation

Target Cuff Inflation:Adjustment Range(in 5

Technical Specifications

II D-25 adult sensorOXISENSOR II N-25 neonatal/adult sensorOXISENSOR II l-20 infant sensorOXISENSOR II D-25L adult sensor, long cable

Accuracv2.5 digits2.5 digits2.5 digits2.5 digits3.0 digits3.0 digits3.5 digits3.5 digits3.5 digits3.5 digits2.0 digits2.0 digits2.0 digits2.0 digits2.0 digits

OXICLIQ-I infant sensorOXICLIQ-A adult sensorOXICLIQ-N neonatal/adult sensorOXIBAND pediatric/infant sensorOXIBAND adult/neonatal sensorDURA-Y ear clipREFLECTANCE sensorDURASENSOR adultPEDI-CHECK pediatric spot-check clipOXISENSOR II D-20 pediatric sensorOXISENSOR

100%)NELLCOR SensorOXICLIQ-P pediatric sensor

-

IVAC probes and probe covers are used. Refer to Appendix D forreorder codes.

Functional Oxygen Saturation:RangeAccuracy

0 to 100%0 to 69%: unspecified

Adult Accuracv (70%

IVAC probes and probe covers. The size, shape, and thermalcharacteristics of the probe covers can affect the performance of theinstrument. Inaccurate readings or retention problems may occur unless

3~ 0.6” C

Determination time less than 60 seconds

Use only

1.O” F+ 1

+ 0.2” F (when tested in acalibrated liquid bath; meets

ASTM El 112, Table 1, inrange specified)

Predictive mode accuracy

&O.l”C

FMin: 26.7” C; 80.0” F

Monitor mode accuracy

Monitor mode Max: 42.2” C; 108.0”

mW (max)mW (max)

Red: 30

beats/min

Audible Indicator Pitch changes withsaturation; volumeselectable from 0 (off) to 9

Waveforms

Sensor Connect/Disconnect From Patient

Pulse Detection

Loss of Pulse

Sensor Light SourceWavelength

Power Dissipation

Pulse plethysmographwaveform on LCD gaincompensated

Monitor will detectattachment ordisconnection of sensorfrom patient within 15 s

Monitor will detect pulseor enter no signal statewithin 15 s of beingattached to patient

Monitor will detect loss ofpulse from patient and enterno signal state within 10 s

Infrared: 920 nm (nominal)Red: 660 nm (nominal)

Infrared: 22.5

f3

NEI_I_COR’s sensor specifications.

Pulse Rate Range 30 to 250 beats/minAccuracy

+2).Note: Refer to

+3, rather than

+_l digit to accountfor the theoretical effect on oximeter measurements of fetalhemoglobin in neonatal blood (e.g., N-25 accuracy on neonatesis

100%)

When sensors are used on neonatal subjects as recommended,the specified accuracy range is increased by

- (70% Accuracv

OXISENSOR R-l 5 adult nasal sensor**Accuracy: 80% to 100%; 0 to 79%: unspecified.

3.5 digits

Neonatal

Appendix A

“C with power save mode

36VA,supplied from a source conformingto IEC 601-l.AC input is protected by twointernal fuses, replaceable byqualified service personnel only. DCinput line is protected by an internalauto-resetting fuse.Battery: 12 volt, 2.3 amp- hoursprotected by internal auto-resettingfuse.Minimum operation time:2 hrs (5 min cycle with adult cuff at25

SOVA.Protection against electrical

shock: Class 1DC input voltage: 24 VDC(nominal), 12-30 VDC,

- 63 Hz (range),- 253 VAC, 47 / 60 Hz (nominal)

90

loo-240 VAC,50

IPXl

AC input voltage:

_,

Degree of protectionagainst harmful ingress ofwater: Drip-proof

_>

,

,

Self-supporting on rubberfeet or pole mountable

Carried by recessedhandle or pole mounted

Mode of operation:continuous

>.

I

_I*

Rewemen&

66

Height: 9.8 in (25.0 cm)Width: 9.8 in (24.8 cm)Depth: 6.9 in (17.5 cm)

7.8 lb (3.5 kg)

.Power

Dimensions

Weight, Including Battery

Mountings

Portability

Classification Information

IPXl. No harmful effects will comeof vertically falling drops of water makingcontact with the Monitor.

67

IPXIconforms with the IEC 529 standard atlevel of

DINAMAP@ PRO Monitor is protectedagainst vertically falling drops of water and

CISPR 11(Group 1, Class A) forradiated and conductedemissions.

The

hPa

Humidity Range 0% to 95% noncondensing

Radio Frequency Complies with IECPublication 601-l-2 (April1993) Medical ElectricalEquipment, ElectromagneticCompatibility Requirementsand Tests and

hPa to 1060

“F)

Storage/TransportationAtmospheric Pressure 500

-I- 122 “F to “C

(- 4 “C to + 50 - 20

hPa

Storage Temperature

hPa to 1060

“F)

Operating Atmospheric Pressure 700

“F to + 104 “C

(+ 41 “C to + 40

nvlronmentalOperating Temperature + 5

Appendix Aenabled) from full charge. Timefor full recharge: 1 hr 50 minfrom full discharge when theMonitor is switched off and 8hrs when the Monitor isswitched on.

7.

69-.7

SpO,) will flashthe most recent reading and an audible alarm will be issued.

Pressing the Alarm Silence switch (causing the integral LEDto be lit) silences the audible alarm for 2 minutes, but thealarm display reading and SILENCE LED indicator willcontinue to flash at the same rate.

System AlarmsSystem alarms alert the operator to certain abnormalconditions or internal system failures. Pressing the rotorcancels the alarm information box which is displayed on theLCD. Codes for different procedural and system alarms areon the next page.

Failsafe AlarmThe failsafe alarm, which is the most powerful alarm of thePRO Monitor, indicates a serious failure of the Monitor.

This alarm occurs immediately upon any failure of a self-testand indicates system failure. When the failsafe alarm occurs,the Monitor disables all features to ensure patient safety.

Appendix BAlarm CodesAll alarm indications are accompanied by an audible signalunless Alarm Silence is selected.

A microprocessor system failure will generate a high-pitchedaudible alarm regardless of the setting of the Alarm Silenceswitch.

There are three categories of alarms: patient alarms, systemalarms, and failsafe alarm.

Patient AlarmsPatient alarms include those alarms issued when thepatient’s systolic pressure, diastolic pressure, pulse rate, oroxygen saturation is outside the set limits. Whenever oneof these conditions occurs, the associated display(SYSTOLIC, MAP, DIASTOLIC, PULSE, or

-70

DINAMAP@ PRO Monitor are in three priority

levels. They are:

Alarm Priority LevelFailsafe 1

Patient and system 2 (High priority alarm)Low battery 3

The Priority 1 alarm (i.e., Failsafe) will override any otheralarm. Priority 2 alarms will override only the low batteryalarm. The low battery alarm will not override any otheralarm.

Hierarchy of AlarmsAlarms in the

I

-C

learO

verpressure detectedadjustable

NO

0 fl~

~:~

tes

%%

!?%

&e

P

RE

SS

UR

E

OV

ER

zkn

ge

N

O0

INFLT

alarm. V

olume

Clear

silenceadjustable

or air leak detected

. .

> 40 secondsN

33change T

IME

OU

T:

-H

igh priority2 m

inutesInflation tim

e

> 2change T

IME

OU

T: T

OT

AL

alarm. V

olume

Clear

silenceadjustable

minutes. M

otion artifact

No

N33 -

2 minutes

Determ

ination time

No

N44

> 1N

55change T

IME

OU

T: P

RE

SS

alarm. V

olume

Clear

silenceadjustable

minute. M

otion artifact

High priority

N44

-H

igh priority2 m

inutesO

ne cuff pressure for

NIB

P F

AILE

Dsilence

adjustableinsufficient signal

No

N55

N99

alarm. V

olume

Clear

determination due to

change

NIB

P-

High priority

2 minutes

Unable to m

ake an N

99

SelectK

no b

No

Procedural and E

rror Alarm

Codes

Effect o

fE

ffect ofA

larmLE

DLC

D D

isplayA

udible ToneA

larm S

ilence

Clear via

Probable C

auseC

od

e Disp

layan

d V

olu

me

Sw

itch

set or

attempting axillary tem

p

Predictive tem

peratureexceeds upper range

> 60

SpO

, sensor or cablepossibly defective. C

ablenot connected properly

Tem

perature probe notconnected or inoperable

Predictive tem

peraturedeterm

ination

SpO

, signal weak or noisy.

Sensor failure

SpO

, sensor not connected.N

o sen

sor c

od

e detected.

Sensor failure

Sp

O, sig

nal.

Check or reposition sensor

Zlear

Clear

Clear

Clear

Clear

Clear

Clear

Pro

bab

le Cau

se

No

or very lo

w

SelectK

nob

;ilen

ce

2m

inutessilence

2m

inutessilence

2m

inutessilence

2m

inutessilence

2m

inutessilence

Effect o

fC

lear via

;ilence

2m

inutes

2m

inutes

4larm S

ilence

Sw

itch

2dj$

ahIe

Effect o

f

-

TE

MP

: FA

IL

HIG

H T

EM

P

Audible Tone

and

Vo

lum

e

High priority

alarm. V

olume

adjustable

High priority

alarm. V

olume

adjustable

High priority

alarm. V

olume

adjustable

High priority

alarm. V

olume

adjustable

High priority

alarm. V

olume

adjustable

High P

riorityalarm

. Volum

eadjustable

High P

riorityalarm

. Volum

e

-T

EM

P: F

AIL

EOO

SpO

, CA

BLE

?

E33

SP

O,

PLA

CE

ME

NT?

SpO

, SE

NS

OR

-N

O

;pO

, NO

SIG

NA

L

PO0 - .

LC

D D

escriptio

n

‘55 E

hange

No

change

No

change

Values

zeroed

No

change

No

change

Blank

Procedural and E

rror Alarm

Codes (cont.)

4larmC

od

e

P55

PO0

No

Code

No

Code

E33

EOO

No

Code

LED

Display

NO

Svolum

e1,

E, P,

Blank

descriptionm

aximum

No effect

No effect

Internal system fault

N,

3ther:E

rror code,S

teady tone,

NIB

P algorithm

returned

Code P

ostedE

RR

OR

alarm. V

olume

silenceC

learvalue outside specified

adjustableaccuracy range

NIB

P R

AN

GE

High P

riority2 m

inutes

-

Code C

hange NO

PA

PE

R

High P

riorityalarm

. Volum

e2 m

inutessilence

Clear

Paper ran out or printer

adjustabledoor open

No

Values

NIB

P m

easurement disabled

No N

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-1

BP Determination Sequence

75

t TIME

1

mmHg for neonates depending on the initial targetpressure preset. After inflating the cuff, the Monitor beginsto deflate it and measures systolic pressure, mean pressure,and diastolic pressure. When the diastolic pressure has beendetermined, the Monitor finishes deflating the cuff andupdates the systolic, diastolic, and MAP displays on thefront panel.

The Monitor deflates the cuff one step each time it detectstwo pulsations of relatively equal amplitude. The timebetween deflation steps depends on the frequency of thesematched pulses (pulse rate of the patient). However, if theMonitor is unable to find any pulse within several seconds,it will deflate to the next step. The process of finding twomatched pulses at each step provides artifact rejection dueto patient movement and greatly enhances the accuracy ofthe Monitor. The figure shows the BP determination

sequence.

OSCILLATION

mmHg for adult/pediatric patients, or1 10

Appendix CPrinciples of Noninvasive Blood PressureDeterminationThe oscillometric method of determining BP isaccomplished by a sensitive transducer which measures cuffpressure and minute pressure oscillations within the cuff.The first determination sequence initially pumps up to a cuffpressure of about 160

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DINAMAP@ Technologyof the PRO Monitor compares BP values to an invasivearterial BP measurement technology. The auscultatorymethod uses audible sounds heard through a stethoscopeand determines BP by the corresponding height of acolumn of mercury.

Invasive pressure monitoring directly measures the pressureexerted on a transducer and displays this pressure as avalue. Noninvasive blood pressure monitoring is dependenton the flow of blood through the peripheral circulation.

77

mmHg above theimmediately preceding inflation. This additional inflation willoccur only once per determination.

Do not use the auscultatory method to verify the accuracyof the Monitor. Because of differences in technique andtechnology, values may differ. The

mmHgmaximum), and resume normal deflation sequence. Thisadditional inflation will occur only once per determination.

If a previous valid systolic pressure is displayed, and the newsystolic pressure oscillations are compared with theprevious valid determination and the Monitor “thinks” thatthe systolic was not obtained, the Monitor will inflate thecuff to a pressure of an additional 50

Appendix Cabsence of a systolic value, stop deflation, reinflate to ahigher (than initial) inflation pressure (290

Medcial SystemsALAR6 **IVAC is a trademark of

DINAMAP@ PRO Monitor Service Manual 777105’

*PRO Monitor unique parts

DINAMAP@ PRO Monitor Operation Manual 776995’IVAC** Temperature Probe Covers 088015IVAC** Rectal Temperature Probe 088013IVAC** Oral Temperature Probe 088012

Discon. 88847

/ Pediatric Hose 10736612 Foot (approx. 3.7 m) Long Neonatal Hose 107368

12 Foot (approx. 3.7 m) Long A/P Hose Quick

/ Pediatric Hose 10736524 Foot (approx. 7.3 m) Long Adult

CLASSIC-CIJFC”, Neonatal Type 5 261912 Foot (approx. 3.7 m) Long Adult

CLASSIC-CUp”, Neonatal Type 4 2623CLASSIC-CUFT”, Neonatal Type 3 2628CLASSIC-CUp”, Neonatal Type 2 2633

1 2638CLASSIC-CUp”, Neonatal Type

CLASSIC-CUFT”, Thigh 2648M, Large Adult 2643f

CLASSIC-CIJp”, Adult 2603

CLASSIC-CU

CLASSIC-CUP”, Small Adult 2608CLASSIC-CIJp”, Child 2613CLASSIC-CUFC”, Infant 2618DURA-CUF@ Cuff, Child Pack 2697DURA-CUF@ Cuff, Assortment Cuff Pack 2699DURA-CUF@ Cuff, Thigh 2796DURA-CUF@ Cuff, Large Adult 2791DURA-CUF@ Cuff, Adult 2774DURA-CUF@ Cuff, Small Adult 2779DURA-CUF@ Cuff, Child 2781DURA-CUF@ Cuff, Infant 2783SOFT-CUP”, Neonatal Type 5 2525SOFT-CUP”, Neonatal Type 4 2524SOFT-CUp”, Neonatal Type 3 2523

FT”, Neonatal Type 2 24221 2521

SOFT-CU SOFT-CUP”, Neonatal Type SOFT-CUP”, Thigh 2505SOFT-CUP”, Large Adult 2504SOFT-CUFT”, Adult 2503SOFT-CUFT”, Small Adult 2502SOFT-CUFT”, Child 2501SOFT-CUP”, Infant 2500

-1 Appendix DCompatibility Table and Reorder CodesDescription of Compatible Parts Code

2796/2505/2648 Hose (quickdisconnect)

38cm-50cm

A/P12 ft (366 cm) Air

2791/2504/2643/2642 or88847 Long

2774/2503/2603/2602 Clippard screwconnectors at cuff

end)31 cm-40cm

2779/2502/2608/2607 107366 Adult 24 ft(732 cm) Air HoseGray (made with

23 cm-33cm

17cm-25cm

2781/2501/2613 connectors at cuffend)or

l2cm-19cm

2703/2500/2618 (366 cm) Air HoseGray (made withClippard screw

8cm-13cm

8cm-15cm 252512619

ADULT/PEDIATRICCUFF TYPE

Infant

Child

Small Adult

Adult

Large Adult

Thigh

LIMB REFERENCE NUMBER USE WITH HOSECIRCUMFERENCE NO.

107365 Adult 12 ft

2524/26237cm-13cm

ft (366

cm)6cm-11 cm 252312628

Neonatal, 12

2422/2633 107368 Teal Green,- 8 cm

- 6 cm 252112638

4 cm

#5

LIMB REFERENCE USE WITH HOSECIRCUMFERENCE NUMBER NO.

3 cm

#4

#3

#2

#l

DSlOOABP Cal Kit 320246

*PRO Monitor unique partsNELLCOR is a trademark of Mallickrodt, Inc.

NEONATALCUFF TYPE

SCPl o*NELLCOR Finger Sensor

SpOz Extension Cable

12 Volt Lead Acid Battery 633132Accessory Pole/Basket 3210Accessory Base 3211Power Converter 621262’Printer Paper (box of 10) 089 1 00*Power Cable 316579NELLCOR

,-

K 83

nof immerse cuffs without prior application of cuffhose caps.

Materials

l Enzymatic detergent such as ENZOL* enzymaticdetergent (US) or Cidezyme* enzymatic detergent (UK)

l Distilled water

l 10% solution of household bleach (5.25% sodium*Trademark hypochlorite) in distilled water

SOFT-CUF@ Blood Pressure Cuffs without affecting theperformance of the cuff.

While this procedure is adequate for cleaning/disinfection, it may not remove all stains.

Do not immerse hoses.

Do

DURA-CUF@Blood Pressure Cuffs and once on

.

Apply cuff hose plugs before cleaning.

The following cleansing procedure was repeated 20times on

.

.

l

intermediate-level disinfection.

. Do not clean with isopropyl alcohol or other solvents.

l Do not immerse hoses.

Cuff Cleaning and DisinfectionGeneralThe cuff must be thoroughly cleaned with the specifieddetergent before reuse. The additional use of householdbleach as described below provides at least

Appendix FMaintenanceCleaning the MonitorThe Monitor and accessories are to be kept clean and usedaccording to the instructions provided here and in theService Manual.

The exterior of the Monitor may be wiped clean with a softcloth slightly dampened with mild detergents. The Monitorand accessories should be inspected once yearly for wearand damage.

l Do not immerse unit.

1-i

SpO, SensorsAdhesive sensors are sterile and for single use only.Reusable sensors should be cleaned before reuse with a70% alcohol solution. Do not immerse the sensorcompletely in water, solvents, or cleaning solutions(because the connector is not waterproof). Do not sterilizethe sensor by irradiation, steam, or ethylene oxide. If

84

_.

The user has the responsibility to validate any deviationsfrom the recommended method of cleaning anddisinfection.

For additional information on infection control procedures,contact Critikon Technical Support.

Temperature DevicesDo not immerse predictive temperature probes. The probemay be cleaned with an alcohol solution. Use a cloth orsponge-just damp, not wet-and avoid getting any liquidinto the interior of the probe.

i

,*

.

,I

II

./,

.,.

I

.:

.I

Procedure1. Prepare the enzymatic detergent according to the

manufacturer’s instructions and the 10% bleach solution,in separate spray bottles.

2. Spray the detergent liberally on device. If the material isdried on, allow the cuff to sit for 1 minute. For soil onthe soft part of the closure or the cuff itself, wipe thematerial off with a soft cloth. For persistentcontamination on the soft part of the closure, use a soft-bristled brush to loosen particles. Rinse with copiousamounts of distilled water. Repeat until no visiblecontamination remains. For soil on the hook part of theclosure, use a soft-bristled brush to remove the material,and rinse with copious amounts of distilled water. Repeatuntil no visible contamination remains.

3. Spray the 10% bleach solution on the affected area untilthe area is saturated. Allow the cuff to sit for 5 minutes.

4. Wipe away any excess solution and rinse the cuff againwith distilled water. Allow 2 hours for drying.

- Spray bottles

.,/:l Soft cloths and soft-bristled brushes

.

To ensure that the battery will be ready for portableoperation, keep the Monitor connected to a mainssupply whenever possible.

Repeated failure to fully charge the battery will resultin a significant reduction in battery life.

.

Appendix Fdisposable sensors or their packaging are damaged, theymust be disposed of as advised in Appendix F.

Storage and Battery CareIf it becomes necessary to store the Monitor for anextended period of time, first fully charge then remove thebattery. Then store the Monitor and the battery in theoriginal packaging materials.

Batteries should always be fully charged before beingplaced in storage. Even after 6 months of storage, a fullycharged battery can retain about 80% of its charge. A fullycharged battery in good condition will provide sufficientpower to operate a Monitor for approximately 2 hours,including temperature and BP measurements made atS-minute intervals.

It is best to keep the battery charged as fully as practicaland never store the Monitor with the battery in a dischargedcondition. When the battery will no longer hold a charge,remove and replace it with one of the same part number.Failure to replace the battery with the same Critikon partnumber may result in shorter battery life.

To charge the battery, insert the plug from either the ACmains power cord or the AC-DC power converter into anappropriate AC outlet. The battery will charge regardless ofthe position of any switches.

Battery charging will take place as long as the Monitorremains connected to an external AC power source. Abattery that is fully discharged can be fully recharged inhour 50 minutes when the Monitor is switched off or 8hours if the Monitor is switched on.

Cautions

1

._-86

._

DINAMAP PRO Monitor Service Manual, available fromCritikon.

Disposal of Product WasteAs you use the PRO Monitor, you will accumulate solid wastesthat require proper disposal or recycling. These includebatteries, patient applied parts, and packaging material.

.

A leak test of the BP parameter should be performed at leastonce a year or when there is doubt about the validity of thepressure readings.

Caution: Refer calibration and leak testing to qualifiedservice personnel. Full calibration details are available in the

.

+5 Voutput on the host port connector.

CalibrationCalibration of the BP parameter should be checked at leastonce a year or when there is doubt about the validity of thereadings.

Leak Testing

l The expected lifetime of the battery largely depends onthe way in which the Monitor is used. If the battery isallowed to completely discharge before being fullyrecharged, the battery should survive around 200recharge cycles. If the battery is used in such a way thatit never becomes more than one third discharged and isfully recharged whenever possible, it can survive up to1200 cycles. This means that by thoughtful usage, thelifetime of the battery can be extended up to six times.

Replacement batteries may be obtained from Critikon.Note: The replacement part number of the battery is 63313.Do not use other types.

FusesThe Monitor contains five fuses. Two AC line input fuses aremounted internally and are replaceable only by qualifiedservice personnel. The remaining three fuses are auto-resetable and mounted within the Monitor. These fusesprotect the low voltage DC input, the battery, and the

SpO, sensors), are intended for single use andshould be disposed of properly as medical waste inaccordance with regional body controlled guideline.

Other patient applied parts, such as blood pressure cuffs,should be cleaned according to instructions. Inspectreusable applied parts for wear, replace as necessary, anddispose of used product as medical waste in accordancewith regional body controlled guideline.

Packaging MaterialRetain original packaging materials for future use in storingor shipping the Monitor and accessories. Thisrecommendation includes corrugated shippers and inserts.

Whenever possible recycle the packaging of accessoriesand patient applied parts.

87

Appendix FBatteriesCaution: Do not incinerate batteries.The sealed, rechargeable backup battery contains lead andcan be recycled. The rechargeable memory battery is ofthe Nickel Metal Hydride form. Discharge this battery priorto disposal. Place the battery in packaging whichelectrically isolates its contents. Do not puncture or placethe battery in a trash compactor. Do not incinerate thebattery or expose it to fire or high temperatures. Dispose inaccordance with regional body controlled guideline.

Patient Applied PartsCertain patient applied parts, such as those with adhesive(disposable

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