CRITIKON DINAMAP Pro Series 100 - 400 Operation Manual

Df NAMAP” PRO Monitor Operation Manual This manual is for DINAMAP@ PRO Monitor Models 100, 200, 300, and 400, all with printers. l

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PRO 100: BP and Pulse PRO 200: BP, Pulse, and Temp PRO 300: BP, Pulse, and SpO, PRO 400: BP, Pulse, Temp, and SpO,

The model of the Monitor determines which menu option buttons appear on the LCD. Please refer to applicable sections.

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: Critikon Marketing Services 4502 Woodland Corporate Boulevard Tampa, FL 33614 1-877-274-8456 Part No. 776995C The content of this document including all figures and drawings is proprietary information of Critikon, provided solely for purposes of operation, maintenance or repair, and dissemination for other purposes or copying thereof is prohibited without prior written consent by Critikon, Tampa, Florida. Illustrations may show design models; production units may incorporate changes.

Contents Introduction ...

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About the DINAMAP@ PRO Monitor.. ... 7 Product Compliance ... 70 Symbols ... . ...11

Getting Started ...

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Unpacking the Monitor and Accessories ... . ... . ... 13 Power Sources ... . ... 13 Powering t.he 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 ... 21

Using the Monitor ... 23 Noninvasive Blood Pressure Determination ... 23 Procedures ... . ... 27 Manual Mode ... 29 Auto Mode ... 29 Stat Mode ... 30 Predictive Temperature Determination ... 3 1 Procedures ... 32 spa* ... ... ... . ... ... .,..,...,...,...,..., ... 34 Procedures ... 36 Troubleshooting ... 39

Using the Menu System ... 43 Introduction ... 43 Liquid Crystal Display ... 43 46 Rotor ... ... Menu Tree ... 46 Main Menu ... . ...__ 46 Vitals Button (UK: All Obs) ... 47 More ... Button ... 48 Set BP Button (UK: BP Mode) ... . ... 48 Alarms Button ... 49 Trend Button ... 51 Print Button ... 53 More ... Menu ... 53 SpO2 Button (Models 300 and 400) ... 54 54 Config Button ... 54 Mode) ... Pwr Sav (Sleep 55 ... Time 56 ... Rotor 56 ... Display Button 57 ... Service Button 58 ... Clinician Menu .62 Error and Warning Messages ... Alarms Button ... 62

Appendix A ...

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Technical Specifications ... . ...

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... 63 BP.. ... . ... . ... IVAC Temperature... 63 64 ,. . . ,. . _ ,... .._...__..._... ..,..._,._,...,..,.,...,,... SpOz .,...,... 66 Mechanical _... ... 66 Power Requirements... Environmental...

Appendix B...*...

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Patient Alarms... System Alarms... Failsafe Alarm _..__..._...,... Hierarchy of Alarms...

69 69 69 70

Appendix C...

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Principles of Noninvasive Blood Pressure Determination... 75

Appendix D...

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Compatibility Table and Reorder Codes...

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Appendix E...*.*... 81 Warranty, Service, and Spare Parts... 81 Repairs..._... 82 Packing Instructions... 82 82 Service Manuals . .._...,...,...

Appendix F...*...

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83 Maintenance..._... 83 Cleaning the Monitor... 83 Cuff Cleaning and Disinfection... 84 Temperature Devices... 84 SpOz Sensors... Storage and Battery Care... a5 ... 86 Fuses... 86 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... Calibration... 86 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Leak Testing . . .._..._... Disposal of Product Waste..._..._..._...~... 86

Appendix G...

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Connection Details... Host Port Connector (rear pane))...

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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 DCoperated monitors are primarily intended for use in hospital acute care settings such as outpatient surgery, accident and emergency, labor and delivery, Gl/endoscopy, and medical/ surgical units. The PRO Monitor comes in four different models: PRO 100, 200, 300, and 400, all with printers. 9 PRO 100: BP and Pulse l

PRO 200: BP, Pulse, and Temp

. PRO 300: BP, Pulse, and SpO, l

PRO 400: 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.

lndica tions 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 l

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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.

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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 Critikon-approved power adapters and converters. l

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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 l

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Do not use replacement batteries other than the type supplied with the Monitor. Replacement batteries are available from Critikon. See Appendix D. The PRO Monitor is designed to conform to Electromagnetic Compatibility (EMC) standard IEC 601-l -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.

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Introduction Place the PRO Monitor on a rigid, secure surface. Monitor must only be used with mounting hardware, poles, and stands recommended by Critikon. 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 Critikon-approved applied parts and accessories, is protected against defibrillator damage. Notes l

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. l

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 l

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IEC 601-l :

Class I, 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 IPXl, degree of protection against ingress of water Sterilization/Disinfection, see Appendix F

QD @ us C

DINAMAP@ PRO MONITOR CLASSIFIED WITH RESPECT TO ELECTRIC SHOCK, FIRE AND MECHANICAL AND OTHER SPECIFIED HAZARDS ONLY IN ACCORDANCE WITH CAN/CSA C22.2 NO. 601 .l . ALSO EVALUATED TO IEC-601-2-30.

CC 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.

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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 Critikon. It is recommended that all the packaging case the Monitor must be returned for

be retained, in 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-l 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 externat 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 set). 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 BAlTERY 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 l

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.

9 For continued safety, use only a power cord of listed type SJT, three-conductor, min. No. 18 AWG, terminated in a medical/hospital grade attachment plug, provided with the following cord tag: “Hospital Grade Plug.” Grounding 14

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Getting Started integrity can only be maintained when equipment is connected to an equivalent receptacle marked “Hospital Grade.” l

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.

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Rear Panel Connections 1

Battery compartment cover: Retains and

2 3

internal battery Mains input: Used to connect to AC power supply External power socket: To be used with approved Critikon AC-DC power converter ONLY

protects

Inactive temperature cable storage: Inactive temperature probe cable attaches here (Models 200 and 400) pole or stand 5 Pole clamp: Used to clamp monitor to 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-l-l

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Getting Started

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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 200 and 400) 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 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 “C “F display: Indicates whether temperature is being displayed in degrees Celsius or Fahrenheit (Models 200 and 400)

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 200 and 400) 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 SpOz sensor connector: SpOz sensor extension cable attaches here (Models 300 and 400) 19 Mean arterial pressure display: 3-digit red LED indicates measured MAP in mmHg and shows instantaneous cuff pressure during BP determination 20 SpOz pulse indicator: Yellow LED in heart symbol flashes to indicate that real-time pulse rate measurements are being derived from SpOz signals (Models 300 and 400) 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 SpOz display: 3-digit red LED indicates oxygen saturation in % (Models 300 and 400) 24 SpOz artifact indicator LED: Illuminates when motion artifact is detected (Models 300 and 400) 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

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Getting Started Switching the Monitor On and Off @ To switch the DINAMAP PRO Monitor on, push the ON/OFF switch (16) or press the rotor (21). As the Monitor powers up, it will run

power

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

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. l

Source 1:

SpO, plethysmograph (Models 300 and 400)

. 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 Auto BP determination (if in Auto BP mode), 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.

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Getting Started Any time the paper is loaded, the printer automatically prints a test strip with the DINAMAP@ PRO name on it. If no print is 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.“)

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Installing new paper will cause the Critikon 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. 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

OF/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.

Ca &ions l

The paper is thermally activated; therefore,

do not store it in a

hot place as discoloration may result. l

Use only replacement paper

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rolls (58 mm) from Critikon.

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Using the Monitor Noninvasive Blood Pressure Determination Description The BP parameter is included

in Models 100, 200, 300, and in the 400. Blood pressure is monitored noninvasively 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, (UK: All Obs). The mode, 2. Auto, 3. Stat, and 4. Vitals shown on the LCD (25). which is selected by the user, is 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 (UK: BP Mode) button in the Main menu.

BP

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, 25, 30, 45, 60, 90, and 120 minutes). Press the rotor to confirm the setting. 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 ?-% ”

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while allowing SpOz 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 is below a specified level. to ensure that the cuff pressure 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.

Genera/ Warnings l

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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 2 minutes 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 -24