GE Dinamap Pro 100-400V2 User manual

DINAMAP® PRO

Series 100-400V2

Monitor

Operation Manual

DINAMAP® PRO 400V2 Monitor

DINAMAP® PRO Monitor

Operation Manual

This manual is for DINAMAP® PRO Monitor Models 100V2, 200V2, 300V2, and 400V2, all with printers.

• PRO 100V2: BP and Pulse

• PRO 200V2: BP, Pulse, and Temp

• PRO 300V2: BP, Pulse, and SpO

• PRO 400V2: BP, Pulse, Temp, and SpO

The model of the Monitor determines which menu option buttons appear on the LCD. Please refer to applicable sections. The Model Number 100-400V2 is generic in nature and reflects the range of product codes available. Your product may be labeled with a specific product code such as DINAMAP version of the product's design.

PRO Model 410. "V2" refers to the second

Reissues and Updates

Changes occurring between issues are addressed through Change Information Sheets, Addendums, and replacement pages. If a Change Information Sheet does not accompany this manual, it is correct as printed.

Errors and Omissions

If errors or omissions are found in this manual, please notify: GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard Tampa, FL 33614 1-877-274-8456

Part No. 2009802-001B

The content of this document including all figures and drawings is proprietary information of GE Medical Systems Information Technologies, provided solely for purposes of operation, maintenance or repair, and dissemination for

other purposes or copying thereof is prohibited without prior written consent by GE Medical Systems Information Technologies, Tampa, Florida.

Illustrations may show design models; production units may incorporate changes.

Hierarchy of Warnings and Cautions

A general warning is a statement that alerts the user to the possibility of injury, death, or other serious adverse reactions associated with the misuse of the device. A warning relates to steps in a procedure.

A general caution is a statement that alerts the user to the possibility of a problem with the device associated with its use or misuse. Such problems include device malfunction, device failure, damage to the device or damage to other property. A caution relates to steps in a procedure.

Printed in the U.S.A.

United States

GE Medical Systems Information Technologies 4502 Woodland Corporate Boulevard Tampa, FL 33614

European Representative

GE Medical Systems Information Technologies GmbH Postfach 60 02 65 D-79032 Freiburg, Germany Tel. +49 761 45 43 - 0 Fax +49 761 45 43 - 233

Contents

Introduction ............................................................................7

About the DINAMAP® PRO Monitor ....................................................................7

Product Compliance ...............................................................................................10

Symbols ......................................................................................................................11

Getting Started......................................................................13

Unpacking the Monitor and Accessories ...........................................................13

Power Sources ..........................................................................................................13

Powering the Monitor .............................................................................................13

Rear Panel Connections ..........................................................................................16

Front Panel Controls and Indicators .....................................................................17

Switching the Monitor On and Off.......................................................................19

Liquid Crystal Display (LCD)...................................................................................19

Using the Printer .......................................................................................................20

Installing the Paper ...................................................................................................20

Printer Alarms ............................................................................................................21

Storage ........................................................................................................................22

Using the Monitor ................................................................23

Noninvasive Blood Pressure Determination .......................................................23

Procedures..................................................................................................................27

Manual Mode ............................................................................................................29

Auto Mode.................................................................................................................29

Stat Mode ...................................................................................................................30

TURBO*TEMP............................................................................................................31

Masimo SET NELLCOR

Using the Menu System .......................................................55

Introduction................................................................................................................55

Liquid Crystal Display...............................................................................................55

Rotor ............................................................................................................................58

Menu Tree ..................................................................................................................58

Main Menu.................................................................................................................58

Vitals Button (UK: All Obs) .....................................................................................59

More... Button............................................................................................................60

Set BP Button (UK: BP Mode)................................................................................60

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

Trend Button ..............................................................................................................63

Print Button ................................................................................................................65

More... Menu .............................................................................................................66

SpO

Config Button.............................................................................................................67

Pwr Sav (Sleep Mode) .............................................................................................68

Time .............................................................................................................................69

Rotor ............................................................................................................................69

Temp............................................................................................................................70

Display Button ...........................................................................................................70

Service Button............................................................................................................71

Clinician Menu ..........................................................................................................72

Error and Warning Messages .................................................................................75

Alarms Button ............................................................................................................75

OK Button...................................................................................................................76

SpO2..................................................................................................37

OxiMAXTM SpO2.................................................................................46

Button .............................................................................................................66

Appendix A............................................................................77

Technical Specifications...........................................................................................77

BP .................................................................................................................................77

Temperature...............................................................................................................78

SpO

............................................................................................................................78

Mechanical.................................................................................................................82

Power Requirements................................................................................................82

Environmental............................................................................................................83

Appendix B ............................................................................85

Patient Alarms............................................................................................................85

System Alarms ...........................................................................................................85

Failsafe Alarm.............................................................................................................85

Hierarchy of Alarms..................................................................................................86

Appendix C............................................................................91

Principles of Noninvasive Blood Pressure Determination................................91

Appendix D ...........................................................................95

Reorder Codes...........................................................................................................95

Appendix E ............................................................................97

Warranty, Service, and Spare Parts.......................................................................97

Repairs.........................................................................................................................98

Packing Instructions..................................................................................................98

Service Manuals ........................................................................................................98

Appendix F ............................................................................99

Maintenance ..............................................................................................................99

Cleaning the Monitor...............................................................................................99

Cuff Cleaning and Disinfection..............................................................................99

Temperature Devices............................................................................................100

SpO

Sensors.......................................................................................................... 100

Storage and Battery Care .....................................................................................101

Fuses ......................................................................................................................... 102

Calibration ............................................................................................................... 102

Leak Testing.............................................................................................................102

Disposal of Product Waste .................................................................................. 103

Appendix G .........................................................................105

Host Port Connector (rear panel)....................................................................... 105

Introduction

About the DINAMAP® PRO Monitor

DINAMAP® PRO Monitors provide noninvasive determination of systolic blood pressure, diastolic blood pressure, mean arterial pressure, pulse rate, temperature, and oxygen saturation. These portable AC- and DC-operated monitors are primarily intended for use in hospital acute care settings such as outpatient surgery, accident and emergency, labor and delivery, GI/endoscopy, and medical/surgical units.

The PRO Monitor comes in four different models: PRO 100V2, 200V2, 300V2, and 400V2, all with printers.

• PRO 100V2: BP and Pulse

• PRO 200V2: BP, Pulse, and Temp

• PRO 300V2: BP, Pulse, and SpO

• PRO 400V2: BP, Pulse, Temp, and SpO

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

Indications

The PRO Monitor is intended to monitor one patient at the bedside.

Contraindications

This device is not designed, sold, or intended for use except as indicated.

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

Warnings

• Do not use the PRO Monitor in the presence of magnetic resonance imaging (MRI) devices. There have

been reports of sensors causing patient burns when operating in an MRI environment.

• Do not use the Monitor in the presence of flammable anesthetics.

• To help prevent unintended current return paths with the use of high frequency (HF) surgical equipment, ensure that the HF surgical neutral electrode is properly connected.

• To avoid personal injury, do not perform any servicing unless qualified to do so.

• WARNING: These Monitors should not be used on patients who are connected to cardiopulmonary bypass machines.

• If powering the Monitor from an external power adapter or converter, use only power adapters and converters approved by GE Medical Systems Information Technologies.

• The Monitor does not include any user-replaceable fuses. Refer servicing to qualified service personnel.

• To reduce the risk of electric shock, do not remove the cover or the back. Refer servicing to a qualified service person.

• If the accuracy of any determination reading is questionable, first check the patient’s vital signs by alternate means and then check the PRO Monitor for proper functioning.

Cautions

• Do not use replacement batteries other than the type supplied with the Monitor. Replacement batteries are available from GE Medical Systems Information Technologies. See Appendix D.

• The PRO Monitor is designed to conform to Electromagnetic Compatibility (EMC) standard IEC 601-1-2, 1993 and will operate accurately in conjunction with other medical equipment which also meets this requirement. To avoid interference problems affecting the Monitor, do not use the Monitor in the

presence of equipment which does not conform to these specifications.

• Place the PRO Monitor on a rigid, secure surface. Monitor must only be used with mounting hardware, poles, and stands recommended by GE Medical Systems Information Technologies. See Appendix D.

• The weight of the accessory basket contents should not exceed 6.6 lb (3 kg).

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

• Verify calibration of BP parameter (temp and pulse oximeter do not require calibration). Ensure that the display is functioning properly before operating the PRO Monitor.

• Do not immerse the Monitor in water. If the Monitor is splashed with water or becomes wet, wipe it immediately with a dry cloth.

• Do not gas sterilize or autoclave.

• The PRO Monitor, when used with applied parts and accessories approved by GE Medical Systems Information Technologies, is protected against defibrillator damage.

Notes

• Waveforms may be distorted and readings inaccurate when electrosurgical cautery equipment is used while monitoring with the PRO Monitor.

• The electromagnetic compatibility profile of the PRO Monitor may change if accessories other than those specified for use with the PRO Monitor are used.

• Trend data are retained in the PRO Monitor when it is turned off, except when the default is overridden by selecting the Trend button under the Service menu.

Product Compliance

The DINAMAP® PRO Monitor is classified in the following categories for compliance with IEC 601-1:

• Class l, internally powered

•Transportable

• For continuous operation

• Not suitable for use in the presence of flammable anesthetics

• Not for use in the presence of an oxygen-enriched atmosphere (oxygen tent)

• Type BF applied parts

• IPX1, degree of protection against ingress of water

• Sterilization/Disinfection, see Appendix F

DINAMAP CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH CAN/CSA C22.2 NO.

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

PRO MONITOR

0086

This product conforms with the essential requirements of the Medical Device Directive. Accessories without the CE mark are not guaranteed to meet the Essential Requirements of the Medical Device Directive.

Symbols

The following symbols are associated with the PRO Monitor. Note: The type of model determines which symbols appear on the Monitor.

Attention, consult accompanying documents

Defibrillator-proof type BF equipment

Power ON/OFF

SpO

START/STOP BP

AUTO BP

Battery Power

MAP

mmHg

MAP (Mean Arterial Pressure)

Temperature

Beats Per Minute

BPM

SILENCE

External Communications Port Connector

Artifact

External AC or DC Power Indicator

External DC Power Input

External AC Power Input

SpO

Motion Artifact / Low Perfusion (US)

SpO

Motion Artifact / Low Perfusion (Europe)

Packaging label depicting the transportation and storage atmospheric pressure range of 500 to 1060 hPa.

IPX1

The DINAMAP against vertically falling drops of water and conforms to IEC-529 standard at level of IPX1. Vertically falling drops of water shall have no harmful effects to the Monitor.

PRO Monitor is protected

Getting Started

Unpacking the Monitor and Accessories

Before attempting to use the PRO Monitor, take a few minutes to become acquainted with the Monitor and its accessories. Unpack the items carefully, and check them against the contents checklist enclosed in one of the accessory boxes. This is also a good time to check for any damage or shortage. If there is a problem or shortage, contact GE Medical Systems Information Technologies.

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

Power Sources

The PRO Monitor is designed to operate from either an internal lead-acid battery, AC mains or an IEC 601-1 compliant DC power source (see Appendix A). For replacement rechargeable batteries, please refer to the Service section of this manual.

The Monitor contains five fuses. Two AC line input fuses are mounted internally and are replaceable only by qualified service personnel. The remaining three fuses are autoresetable and mounted within the Monitor. These fuses protect the low voltage DC input, the battery, and the +5 V output on the host port connector.

Powering the Monitor

Before the PRO Monitor is used for the first time, the battery should be charged in the Monitor for at least 8 hours.

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

Refer to the illustration of the front panel controls and indicators. With mains or external DC power connected, the green external power indicator LED (14) will light to indicate that external power is being applied and that the battery is

charging. If the battery is not inserted, the external power indicator LED will flash (short flash approx. every 4 sec). When the Monitor is running on battery power, a battery icon appears in LCD area 3 (toggling with the time indicator) indicating the charge status.

During battery-only operation, the yellow battery power indicator LED (17) will light. When the battery becomes discharged beyond the low battery threshold, the indicator will begin to flash, and the Monitor will sound warning beeps every 30 seconds. At this point, the Monitor should be connected to an AC outlet to recharge the battery. If the Monitor continues to be used without charging the battery, the message WARNING: THE BATTERY IS TOO LOW FOR MONITOR TO FUNCTION. TURN MONITOR OFF appears. The Monitor shuts down all functions until it is turned off and the battery is recharged or replaced. To run the Monitor on AC power, it must be powered off and then on again.

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

Notes

• To prolong the life of the battery, keep the Monitor connected to an AC outlet whenever possible. NEVER allow the battery to become completely discharged. A fully charged battery will power the Monitor for approximately 2 hours and should survive between 200 and 500 charge/discharge cycles. When it is necessary to replace the battery, refer to the “Compatibility Table and Reorder Codes” listed in Appendix D. To ensure full charge cycles, replace only with a recommended battery. If the Monitor is to be stored for some time, first charge the battery and then remove it and store it separately from the Monitor.

• For continued safety, use only a power cord of listed type SJT, three-conductor, min. No. 18 AWG, terminated

Getting Started

in a medical/hospital grade attachment plug, provided with the following cord tag: “Hospital Grade Plug." Grounding integrity can only be maintained when equipment is connected to an equivalent receptacle marked "Hospital Grade."

• Where the integrity of the external earth conductor in the installation or its arrangement is in doubt, the Monitor must be 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) and the patient at the same time.

Rear Panel Connections

1 Battery compartment cover: Retains and protects internal

battery.

2 Mains input: Used to connect to AC power supply. 3 External power socket: To be used with approved GE

Medical Systems Information Technologies AC-DC power converter ONLY.

4 Inactive temperature cable storage: Inactive temperature

probe cable attaches here (Models 200V2 and 400V2).

5 Pole clamp: Used to clamp monitor to pole or stand. 6 Data interface connector: Host communications port

(15 way D-type RS-232 serial port) for use only with equipment conforming to IEC 601-1, configured to comply with IEC 601-1-1.

Getting Started

Front Panel Controls and Indicators

7 Systolic pressure display: 3-digit red LED indicates

measured systolic BP in mmHg.

8 Active temperature probe holster: Temperature probe

that is being used stored here (Models 200V2 and 400V2).

9 Diastolic pressure display: 3-digit red LED indicates

measured diastolic BP in mmHg.

10 Temperature probe cover storage: Box of probe covers

stored here (Models 200V2 and 400V2).

11 Inactive temperature probe holster: Extra temperature

probe can be stored here (Models 200V2 and 400V2).

12 Temperature display: 4-digit red LED indicates measured

temperature (Models 200V2 and 400V2).

13 °C °F display: Indicates whether temperature is being

displayed in degrees Celsius or Fahrenheit (Models 200V2 and 400V2).

14 External power indicator: Green LED indicates external

power status and battery charging status of monitor.

15 Temperature probe connector: Temperature probe cable

attaches here (Models 200V2 and 400V2).

16 ON/OFF switch: Controls on/off state of monitor; push

for power on and push again for power off.

17 Battery power indicator: Yellow LED indicates operation

and charge status of internal battery.

18 SpO

sensor connector: SpO2 sensor extension cable

attaches here (Models 300V2 and 400V2).

19 Mean arterial pressure display: 3-digit red LED indicates

measured MAP in mmHg and shows instantaneous cuff pressure during BP determination.

20 SpO

pulse indicator: Yellow LED in heart symbol flashes

to indicate that real-time pulse rate measurements are being derived from SpO

signals (Models 300V2 and

400V2).

21 Rotor: Used to highlight and select items in LCD menus; if

monitor is off, pressing rotor will switch monitor on.

22 Pulse BPM display: 3-digit yellow LED shows pulse rate in

beats per minute.

23 SpO

display: 3-digit red LED indicates oxygen saturation

in % (Models 300V2 and 400V2).

24 SpO2 motion/artifact indicator LED: For NELLCOR, LED

Illuminates when motion artifact is detected (Models 300V2 and 400V2). For Masimo, LED illuminates when low perfusion or low signal quality is detected. (Models 300V2 and 400V2).

25 LCD (liquid crystal display): Displays all alarms, user

interface messages, and configuration options.

26 Alarm silence switch: Alternately mutes and enables

audible alarms; when pushed once after alarm sounds (silence on), switch lights to indicate that audible alarms have been silenced for 2 minutes.

27 AUTO BP key: Press to start Auto BP mode. 28 Light sensor: Automatically measures ambient light to set

LED display intensity.

29 START/STOP BP key: Press to start or stop a BP, Auto,

Stat, or Vitals determination.

30 Cuff connector: BP cuff hose attaches here.

Getting Started

Switching the Monitor On and Off

To switch the DINAMAP PRO Monitor on, press and hold the power ON/OFF switch (16) for at least 10 seconds or press the rotor (21).

As the Monitor powers up, it will run a short self-test routine, which will flash all the indicator lights and then beep the warning speaker. After a few seconds the system will be ready for operation, as indicated by the appearance of 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 may be 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 an alarm is active. If no controls are used and no determinations are being made, the Monitor will enter sleep mode after a time which can be preset by the operator. All LED displays will be blanked except for a dash in the far-left systolic position, and any existing readings will be transferred to the LCD, which displays the message “Sleep Mode Active.” Moving the rotor or pressing a key will “wake up” the Monitor.

Liquid Crystal Display (LCD)

Menu Area

This area displays the name of the menu that has option buttons available for selection. Normal text in the menu area

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

Area 2

This area displays data from one of three different sources.

• Source 1: SpO

plethysmograph (Models 300V2 and

400V2)

• Source 2: Last three BP readings

• Source 3: Error and warning messages

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

Area 3

This area displays the time, the time lapsed since the last BP determination, the battery icon (if operating on battery power, the time and battery icon toggle), and the BP and Printer modes.

Using the Printer

Installing the Paper

Turn the PRO Monitor so that the side is facing you. While grasping the side of the Monitor, firmly press the notched indentations on the printer door to open it. The printer door will pop open. With the Monitor powered on, place the roll of paper into the compartment so that the end of the paper comes off the top, and thread it between the two printer plates. As the paper touches the plates, the paper will begin to auto-feed itself into the printer. Feeding the end of the paper strip through the slot in the door, firmly press the notched indentation on the side of the printer door to close it. Use the paper release lever to clear a paper jam or manually feed the paper. Note: Make sure that the roll of paper is tightly wound.

Getting Started

Any time the paper is loaded, the printer automatically prints a test strip with the DINAMAP visible on the paper, check that the paper roll has been installed in the correct position (refer to diagram). To tear off the printout, use a slight sideways action to pull the paper sharply up across the serrated edge of the door.

Printer Alarms

If the Monitor is switched on with no paper installed or with the printer door open, the message “No Paper” will appear next to “PRNT” in Area 3 of the LCD. When new paper is installed and the printer door is closed, the message will change 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 is made to print when no paper is installed, the message “Printer - No Paper” will appear in Area 2 of the LCD and an audible alarm will sound. In addition, the message “No Paper” will appear next to “PRNT” in Area 3 of the LCD. To clear the alarm, press the rotor. The message in Area 3 of the LCD will remain until new paper is installed and the printer door is closed. (See “Using the Menu System.”)

Installing new paper will cause the DINAMAP PRO header to be printed, thereby confirming that the paper is installed correctly and that the printer is operational. The message next to “PRNT” in Area 3 of the LCD will change to “Auto” or “Manual” to identify the operating mode of the printer. After power-off, the operating mode of the printer returns to the previous user-selected setting (Auto or Manual) unless specified otherwise in the Print button under the Service Button.

PRO name on it. If no print is

Storage

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

• exposed to direct sunlight,

• exposed to temperatures over 100 °F/38 °C or relative humidity over 80%, or

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

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

Cautions

• The paper is thermally activated; therefore, do not store it in a hot place as discoloration may result.

• Use only replacement paper rolls (58 mm) from GE Medical Systems Information Technologies.

Using the Monitor

Noninvasive Blood Pressure Determination

Description

The BP parameter is included in Models 100V2, 200V2, 300V2, and 400V2. Blood pressure is monitored noninvasively in the PRO Monitor by the oscillometric method, which measures the amplitude of the pressure oscillations within the blood pressure cuff. Further information about the oscillometric method 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 systolic pressure, diastolic pressure, mean arterial pressure, and pulse rate.

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

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

3. Stat determinations are started by selecting the Stat button under the Set BP button (UK: BP Mode) in the Main menu. In the Stat mode, the blood pressure is determined as many times as possible in 5 minutes.

4. Vitals (UK: All Obs) determinations are started by selecting the Vitals (UK: All Obs) button in the Main menu. (Refer to the “Using the Menu System” section.) Selection of this button initiates a BP determination while

allowing SpO2 and predictive temperature determinations to be monitored and recorded (depending on Monitor model). In the Vitals (UK: All Obs) 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 and automatically uses adult/pediatric monitoring parameters or neonatal monitoring parameters, as appropriate.

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

Instructions for cleaning and disinfecting BP cuffs are in Appendix F.

General Warnings

• The PRO Monitor will not measure blood pressure effectively on patients who are experiencing seizures or tremors.

• Arrhythmias will increase the time required by the PRO Monitor to determine a blood pressure and may extend the time beyond the capabilities of the Monitor.

• In Manual mode, the PRO Monitor displays the results of the last blood pressure determination for a duration of time set by the user or until another determination is completed. If a patient’s condition changes between one determination and the next, the Monitor will not detect the change or indicate an alarm condition.

• Devices that exert pressure on tissue have been associated with purpura, skin avulsion, compartmental syndrome, ischemia and/or neuropathy. To minimize these potential problems, especially when monitoring at frequent intervals or over extended periods of time, make sure the cuff is applied appropriately and

Using the Monitor

examine the cuff site and the limb distal to the cuff regularly for signs of impeded blood flow.

• Do not apply external pressure against cuff while monitoring. Doing so may cause inaccurate blood pressure values.

• Use care when placing cuff on extremity used to monitor other patient parameters.

• The PRO Monitor is designed for use only with dualtube cuffs.

• Use only accessories recommended by GE Medical Systems Information Technologies. Failure to use recommended accessories may result in inaccurate readings. See Appendix D.

• Blood pressure cuffs should be removed from the patient when the Monitor is powered off. If the extremity remains cuffed under these conditions or if the interval between blood pressure determinations is prolonged, the patient’s limb should be observed frequently and the cuff placement site should be rotated as needed.

General Cautions

• Accuracy of BP measurement depends on using a cuff of the proper size. It is essential to measure the circumference of the limb and to select the proper size cuff. The air hoses are color-coded according to size of the patient. The gray 12- or 24-foot hose (3.66 m or 7.3 m) is required on patients who require cuff sizes from infant through thigh cuffs. The teal (blue-green) 12-foot hose (3.66 m) is required for the neonatal cuff sizes #1 through #5.

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

• The pulse rate derived from a BP determination may differ from the heart rate derived from an EKG waveform because the PRO Monitor measures actual peripheral pulses, not electrical signals or contractions from the heart. Differences may occur because electrical signals at the heart occasionally fail to

produce a peripheral pulse or the patient may have poor peripheral perfusion. Also, if a patient’s beat-tobeat pulse amplitude varies significantly (e.g., because of pulsus alternans, atrial fibrillation, or the use of a rapid-cycling artificial ventilator), blood pressure and pulse rate readings can be erratic, and an alternate measuring method should be used for confirmation.

General Notes

• A patient’s vital signs may vary dramatically during the use of cardiovascular agents such as those that raise or lower blood pressure or those that increase or decrease heart rate.

• Because treatment protocols based on the patient’s blood pressure may rely on specific values and differing measurement methods, such as auscultatory, clinicians should note a possible variance from values obtained with the PRO Monitor in planning patient care management. The PRO Monitor values are based on the oscillometric method of noninvasive blood pressure measurement and correspond to comparisons with intraaortic values within ANSI /AAMI Standards for accuracy (a mean difference of ± 5 mmHg, and a standard deviation of ± 8 mmHg).

• Several conditions may cause the BP parameter to calculate and display only the mean arterial pressure (MAP) without a systolic and diastolic reading. These conditions include very low systolic and amplitude fluctuations, so an accurate calculation for these values can’t be made (e.g., patient in shock); too small of a difference between systolic and MAP calculations in relationship to the difference between diastolic and MAP; or a leak has occurred in the PRO Monitor (1. Check all BP connections 2. Monitor may need calibration and leak testing). If only the MAP value is displayed, the systolic and diastolic will display dashes (---) and an alarm message “N99-BP FAILED” will be displayed.

Using the Monitor

Procedures

1. Connect the end of the air hose which has quick-release clips 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, squeeze the quick-release clips together and pull the plug from the cuff connector (30).

2. Select the appropriate blood pressure measurement site. Because normative values are generally based on this site and as a matter of convenience, the upper arm is preferred. When upper arm size or shape, the patient’s clinical condition, or other factors prohibit use of the upper arm, the clinician must plan patient care accordingly, taking into account the patient’s cardiovascular status and the effect of an alternative site on blood pressure values, proper cuff size, and comfort. The figure shows the recommended sites for placing cuffs.

Warning: Do not place the cuff on a limb being used for intravenous infusion or any area where circulation is compromised or has the potential to be compromised.

3. If patient is standing, sitting, or inclined, ensure that cuffed limb is supported to maintain cuff at level of patient’s heart. If cuff is not at heart level, the difference in systolic and diastolic values due to hydrostatic effect must be considered. Add 1.80 mmHg to values for every inch (2.54 cm) above heart level. Subtract 1.80 mmHg from values for every inch (2.54 cm) below heart level.

4. Select appropriate cuff size. Measure patient’s limb and select appropriately sized cuff according to size marked on cuff or cuff packaging. When cuff sizes overlap for a specified circumference, choose the larger size cuff.

Precaution: Accuracy depends on use of proper size cuff.

5. Inspect cuff for damage. Replace cuff when aging, tearing, or weak closure is apparent. Do not inflate cuff when unwrapped. Precaution: Do not use cuff if structural integrity is suspect.

6. Connect the cuff to the air hose. Thread the cuff connectors onto the hose connectors until finger tight. Do not overtighten.

Warning: It is mandatory that the appropriate hose and cuff combination be used. Any attempt to modify the hose will inhibit the Monitor from switching between the neonatal and adult measurement modes. Note: In normal use, each cuff will have its own hose, so it

will not usually be necessary to disconnect them. If it is necessary to do so, carefully unscrew the cuff from the hose. Care should be taken in reconnecting the cuff to a hose, ensuring that threads of the cuff and hose are in alignment and no cross-threading occurs.

7. Inspect patient’s limb prior to application. Precaution: Do not apply cuff to areas where skin is not intact or tissue is injured.

8. Palpate artery and place cuff so that patient’s artery is aligned with cuff arrow marked “artery.”

9. Squeeze all air from cuff and confirm that connection is secure and unoccluded and that tubing is not kinked.

10.Wrap cuff snugly around the patient’s limb. Cuff index line must fall within the range markings. Ensure that hook and loop closures are properly engaged so that pressure is evenly distributed throughout cuff. If upper arm is used, place cuff as far proximally as possible.

11.Proper cuff wrapping should be snug, but should still allow space for a finger between patient and cuff. Cuff should not be so tight as to prevent venous return between determinations.

Warning: Using a cuff that is too tight will cause venous congestion and discoloration of the limb, but using a cuff that is too loose may result in no readings and/or inaccurate readings.

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

Using the Monitor

Manual Mode

To start a determination, press the START/STOP BP key (29). A normal, uninterrupted Manual cycle takes about 40 seconds. The cuff pressure must drop below 5 mmHg (neonate) or 15 mmHg (adult) before another determination can be started. BP information will be displayed for a duration of time set by the user. The factory default setting is 2 minutes (refer to “Retain Values” in the Using the Menu System section for information on how to change this setting). The user can set the display duration in 2, 5, 10, 15, 20, 30, 45, 60, 90, 120 minute increments. If another determination is initiated during the user-set timeframe, the display will change. This applies to 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 to the previous user-selected setting (Auto or Manual) by selecting Set BP (UK: BP Mode) under the Service menu. Note: The START/STOP BP key is an on-off switch; pressing it will stop any BP determination (Manual, Auto, Stat, or Vitals) that is in progress.

Auto Mode

Auto BP determinations are started by selecting the AUTO BP 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 BP determination as long as the Monitor is in Manual BP mode. If the Monitor is already in Auto BP mode, selection of the AUTO BP key (27) brings up the Set BP menu (UK: BP Mode) without starting a new determination until the preset time interval has expired. Pressing the START/STOP BP key during a series of Auto BP determinations will cancel the determination in progress.

When Auto mode is selected, a number at the right of the Auto button indicates the time interval between each reading. To change the time interval, choose the box around the number and turn the rotor until the desired interval is reached. The interval can be set between 1 and 120 minutes (1, 2, 3, 4, 5, 10, 15, 20, 30, 45, 60, 90, and 120 minutes). Press the rotor to confirm the setting. After power-off, the operating mode returns to the default setting of Manual. The default setting of Manual can be overridden to return to the previous user-selected setting (Auto or Manual) by selecting Set BP (UK: BP Mode) under the Service menu.

In the Auto mode, the pressure must be below 5 mmHg (neonate) or 15 mmHg (adult) for at least 30 seconds before another determination can be started. BP information will be displayed on the LED until the next determination is started. This applies to Auto mode only. Note: To cancel an Auto BP determination, select the Manual button in the Set BP menu (UK: BP Mode).

Stat Mode

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

If a Manual determination is not in progress, a 5-minute series of determinations will start. If a Manual determination is in progress, that determination will become the first in the series. A normal, uninterrupted Stat sequence will give the first set of systolic, diastolic, and mean arterial pressure values and pulse rate within 15 to 20 seconds. Selecting the Stat button during a series of Stat determinations will cancel the determination in progress and the rest of the series. BP information will be displayed on the LED until the determination has been canceled or completed. This applies to Stat mode only.

The series begins with cuff inflation to a pressure above the previous systolic pressure or, if no previous systolic value is stored, to approximately 150 mmHg for adult/pediatrics. The

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