Critikon DINAMAP 8100 User manual

DINAMAP™
Portable Adult/Pediatric and
Neonatal Vital Signs Monitor
Model 8100
Operation Manual

LIST OF EFFECTIVE PAGES
U.S. Patent 4,349,034
U.S. Patent 4,360,029
U.S. Patent 4,501,280
U.S. Patent 4,546,775
Patent Pending
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the
order of a health care practitioner.
The content of this document including all figures and drawings is
proprietary information of Johnson & Johnson Medical, Inc., provided
solely for purposes of operation, maintenance or repair, and
dissemination for other purposes or publication or copying thereof is
prohibited without prior written consent by Johnson & Johnson Medical,
Inc.
Photographs may show design models; production units may incorporate
changes.
© Copyright 1994, Johnson & Johnson Medical, Inc. All rights reserved.
Printed in U.S.A.

CONTENTS List of Effective Pages ...........................................................
List of Illustrations................................................................i
v
List of Tables........................................................................i
v
Frontispiece ..........................................................................
v
SECTION 1. INTRODUCTION
General..............................................................................1-
1
Manual Purpose.................................................................1-
1
Manual Effectivity...............................................................1-
1
Reissues.......................................................................1-
1
Change Information Sheets..........................................1-
1
Errors, Omissions, Incorrect Data.................................1-
1
Related Publications..........................................................1-
2
Instruction Labels .........................................................1-
2
Service Manual.............................................................1-
2
Service Policy ....................................................................1-
2
Extended Warranties .........................................................1-
2
Assistance..........................................................................1-
2
Service...............................................................................1-
3
Packing Instructions......................................................1-
3
Insurance......................................................................1-
4
Service Loaners.................................................................1-
4
Repair Parts.......................................................................1-
4
Replacement Accesories ...................................................1-
5
SECTION 2. PRODUCT DESCRIPTION
Overview............................................................................2-
1
Unique Operating Features................................................2-
1
Accessories........................................................................2-
2
Standard Accessories...................................................2-
2
Optional Accessories....................................................2-
2
SECTION 3. PHYSICAL DESCRIPTION
Performance Specifications ...............................................3-
1
Technical Specifications.....................................................3-
2
Mechanical ...................................................................3-
2
Electrical.......................................................................3-
3
Environmental...............................................................3-
3
Controls, Indicators, Connectors........................................3-
4
SECTION 4. FUNCTIONAL DESCRIPTION
Determination Sequence....................................................4-
1
Maximum-Minimum Ranges ..............................................4-
2

Basic Operating Cycle .......................................................4-
3
Operating Modes ...............................................................4-
4
Manual Mode................................................................4-
4
Auto Mode....................................................................4-
4
Neonatal or Adult/Pediatric Monitoring .........................4-
5
Systolic Search.............................................................4-
5
Undetermined Systolic and Diastolic Pressures.................4-
6
CONTENTS
Continued SECTION 5. INSTALLATION AND OPERATION Unpacking..........................................................................5-
1
Content Checklist .........................................................5-
1
Missing Items.....................................................................5-
1
Indications and Contraindications......................................5-
1
Installation and Initial Setup...............................................5-
2
Electrical and Hose Connections..................................5-
2
Operating Warnings, Precautions, and Notes....................5-
5
Operating Procedures........................................................5-
7
Power-ON Procedure.........................................................5-
7
Set Alarm Limits Procedure ...............................................5-
8
Manual Mode...................................................................5-1
0
Auto Mode........................................................................5-1
0
Alarm Indications and Interpretation ................................5-1
1
Patient Alarms..................................................................5-1
1
System Alarms.................................................................5-1
1
Troubleshooting...............................................................5-1
3
Determination Unsuccessful Alarm (899) ...................5-1
3
Power-On Alarm (888)................................................5-1
3
Excess Time at One Pressure Alarm (855) ................5-1
3
Excess Determination Time Alarm (844)....................5-1
4
Excess Inflation Time Alarm (833)..............................5-1
4
Excess Pressure Alarm (800).....................................5-1
4
Monitor Will Not Power-On.........................................5-1
5
Monitor Displays Extremely High Readings................5-1
5
Monitor Displays Extremely Low Readings.................5-1
5
Patient Alarms Activate After Every Determination.....5-1
5
SECTION 6. MAINTENANCE AND CALIBRATION
Maintenance ......................................................................6-
1
Cleaning .......................................................................6-
1
Storage.........................................................................6-
1
Battery Charging...........................................................6-
2
Battery Removal and Replacement..............................6-
3
Changes Fuses ............................................................6-
4
Replacement of Line Power Fuses...............................6-
4
Replacement of Battery Fuse.......................................6-
6

Calibration..........................................................................6-
7
Blood Pressure Calibration Check.....................................6-
7
Cuff and Hose Leak Check................................................6-
9
Performing a Cuff and Hose Pneumatic Leak Check ...6-
9

LIST OF
ILLUSTRATIONS Figure No. Title Pag
e
Frontispiece.....................................................
v
3-1 Front Panel Controls and Indicators.............3-
4
3-2 Rear Panel Controls and Indicators............3-1
1
4-1 Determination Sequence..............................4-
2
4-2 Basic Operating Cycle..................................4-
3
4-3 Low Amplitude Waveform Diagram..............4-
6
5-1 Recommended Cuff Placement....................5-
3
6-1 Cover Removal.............................................6-
4
6-2 Open AC Line Fuse Compartment ...............6-
5
6-3 Remove Fuse Holder....................................6-
5
6-4 Remove Fuse from Fuse Holder...................6-
6
6-5 Replace AC Line Fuse and Fuse Holder......6-
6
6-6 Calibration Check Setup...............................6-
7
6-7 Cuff and Hose Leak Setup .........................6-1
0
LIST OF TABLES Table No. Title Pag
e
3-1 Front Panel Controls and Indicators.............3-
4
3-2 Rear Panel Controls and Indicators............3-1
1
4-1 Maximum and Minimum Detectable
Pressures.....................................................4-
3
5-1 Cuff-to-Hose Compatibility............................5-
3
5-2 Default Alarm Limits .....................................5-
8
5-3 System Alarms Summary...........................5-1
2
6-1 Battery Charging Characteristics..................6-
2
6-2 Calibration Check Pressure Levels...............6-
9

DINAMAP™ Portable Vital Signs Monitor, Model 8100

1-1
SECTION 1. INTRODUCTION
GENERAL The DINAMAP™Portable Vital Signs Monitor 8100 is
designed to noninvasively and automatically measure
systolic and diastolic pressure, mean arterial pressure
(MAP), and pulse rate for neonatal or adult/pediatric
patients. Results are displayed on large, easy-to-read
digital displays. The monitor will operate on AC line voltage
or on its internal battery. The monitor will cycle
automatically at operator programmed intervals between
one and ninety minutes.
The DINAMAP™Portable Monitor Model 8100 is effective
and versatile. It continues to monitor during most clinical
crises when other indirect measurement methods may fail.
The monitor can be used in any hospital area where critical
care is administered, for example, emergency room,
operating room, recovery room, intensive care unit, cardiac
care unit, renal dialysis unit, burn unit, etc.
MANUAL PURPOSE This Operation Manual was prepared for the operator of the
DINAMAP™Portable Monitor Model 8100. This manual
contains installation and operation instructions, device
applications, limitations, and routine performance
verification procedures.
To achieve satisfactory results, the
operator must read this manual thoroughly before
attempting to use the Monitor.
MANUAL
EFFECTIVITY Reissues Change to this manual, either in response to user input or to
continuing product improvements, are accomplished
through reissue.
Change Information Sheets
Changes occurring between reissues are addressed
through Change Information Sheets and replacement
pages. If a Change Information Sheet does not accompany
this manual, it is correct as printed.

1-2
RELATED
PUBLICATIONS Instruction Labels Two permanently affixed labels, one on each side of the
monitor, contain condensed operation and alarm code
information.
Service Manual
The DINAMAP™Portable Monitor Model 8100 Service
Manual (328-370) contains service and repair parts
information directed to qualified service personnel.
WARNING
To avoid personal injury, the user should not
perform any servicing unless qualified to do
so.
SERVICE POLICY The warranty for this product is enclosed with the product in
the shipper carton. All repairs on products under warranty
must be performed or approved by Critikon Company LLC
personnel.
Unauthorized repairs will void the warranty.
Products not covered by warranty should be repaired only
by qualified electronics service personnel.
EXTENDED
WARRANTIES Extended warranties may be purchased on most products. Contact your Sales Representative for details and pricing.
ASSISTANCE If the product fails to function properly, or if assistance,
service, or spare parts are required, contact Critikon
Customer Support. Before contacting Critikon, it is helpful
to attempt to duplicate the problem and to check all
accessories to ensure that they are not the cause of the
problem. If you are unable to resolve the problem after
checking these items, contact Critikon. Prior to calling,
please be prepared to provide
■product name and model number
■a complete description of the problem

1-3
ASSISTANCE
Cont. If the repair parts or service are necessary, you will also be asked to provide
■the product serial number
■the facility's complete name and address
■a purchase order number if the product is to be
repaired or you order spare parts
■the facilities Critikon account number, if possible
■the 6-digit part number for spare or replacement
parts
SERVICE If your product requires warranty, extended warranty or non-
warranty repair service, call Johnson & Johnson Medical
Customer Support and a representative will assist you.
Estimates for non-warranty repairs are provided at no
charge; however, the product must be sent to the Critikon
Service Center in order to provide you with an estimate.
To facilitate prompt service in cases where the product has
external chassis or case damage, please advise the
Customer Support representative when you call.
The Customer Support representative will record all
necessary information and will provide you with a Return
Authorization Number. Prior to returning any product for
repair, you must have a Return Authorization number.
Call Critikon at 1-877-274-8456
and select Parts, Product Service, and Customer Support
(press 2) Monday through Friday, 8:00 a.m. to 8:00 p.m.
EST, excluding holidays.
Packing Instructions
Follow these recommended packing instructions.
■Remove all hoses, cables, sensors, power cords and
ancillary products such as printers and external
battery packs from the monitor before packing.
■Pack only the accessories you are requested to
return; place them in a separate bag and insert the
bag and the product inside the shipping carton.
■Use the original shipping carton and packing
materials, if available.

1-4
If the original shipping carton is not available
■Place the product in a plastic bag and tie or tape the
bag to prevent loose particles or materials from
entering openings such as hose ports.
■Use a sturdy corrugated container to ship the
product, tape securely to seal the container for
shipping.
■Pack with 4 to 6 in. of padding on all sides of the
product.
Insurance
Insurance is at the customer's discretion. Claims for
damage to the product must be initiated by the shipper.
SERVICE LOANERS A loaner unit is provided at no charge during the service life
of the product when the repair service is performed by
Critikon. Within 48 hours of your request, a loaner will be
shipped to your facility.
■Critikon will pay shipping charges for a loaner sent to
the customer for product repairs under the warranty.
■Shipping charges for a loaner sent to the customer for
product repairs not under warranty will be billed to the
customer.
■Shipping charges for the return of a loaner to Critikon
will be paid by the customer.
All loaners provided to customers must be returned within
the specified time stated on the loaner agreement or a
rental fee will be incurred.
REPAIR PARTS Repair parts can be ordered via phone Critikon Customer
Support or via FAX. Exchange replacement assemblies
such as Circuit Board Assemblies also are available; ask
the Customer Support representative for details.
Via FAX ---- 1-813-887-2410
Please allow one working day for confirmation of your
order. All orders must include the following information.
■Facility's complete name, address, and phone
number
■FAX number
■Your purchase order number
■Your Critikon account number

1-5
REPLACEMENT
ACCESSORIES Replacements such as hoses, sensors, etc. must be purchased from Critikon at 1-77-274-8456. Please have
the 4-digit Reorder/Product Code of the item you wish to
order, your purchase order and account number available.

2-1
SECTION 2. PRODUCT DESCRIPTION
OVERVIEW The DINAMAP™Portable Monitor, Model 8100, is designed
to provide operator convenience and reliability when
monitoring vital signs. Features that enhance the
DINAMAP™Monitor's operation follow.
UNIQUE OPERATING
FEATURES ■FULLY AUTOMATIC PATIENT SELECTION AND
MONITORING Senses cuff size and switches
automatically from adult/pediatric monitoring to
neonatal monitoring or vice versa. Can be
programmed to make determinations automatically at
various intervals between 1 and 90 minutes.
■NONINVASIVE AND OBJECTIVE
Helps eliminate risks associated with invasive
monitoring and subjective interpretation of auscultatory
methods.
■OSCILLOMETRIC
No microphones or external transducers are required.
■ARTIFACT REJECTION
By observing pulsations of matched amplitude and
frequency, the monitor is capable of eliminating most
noise and motion artifact.
■SYSTOLIC SEARCH
Tracks rapid pressure changes.
■AUDIBLE/VISUAL ALARM SYSTEM
Provides a visual and audible indication if systolic or
diastolic pressures, mean arterial pressure (MAP), or
pulse rate fall outside of operator programmable
high/low limits and of abnormal system conditions or
hardware failure.
■COMPUTER INTERFACE
Rear panel data interface terminal for routing data to
host computer.

2-2
UNIQUE OPERATING
FEATURES (Cont.) ■AUTOMATIC PRESSURE ZEROING
Microcomputer automatically establishes the zero
pressure reference before each determination, thus
reducing the need for constant calibration verification.
■PRIOR DATA RECALL
Recalls from up to 100 previous determinations during
the last 99 minutes of elapsed time.
■DIGITAL DISPLAYS
Large, easy-to-read digital displays (via high intensity
LEDs) provide continuous readout of the most recent
patient parameter values.
■FULLY PORTABLE OPERATION
The monitor can be operated from a fully charged
internal battery for a minimum of 6 hours (in 5 minute
cycle mode with adult cuff attached) or from AC power
using AC line power cord.
ACCESSORIES The accessories listed are either standard items shipped
with the monitor or optional items which can be ordered
separately.
Standard Accessories Reorder No.
DURA-CUF™Bladderless
Blood Pressure Cuff
Adult
Re
g
ular
(White)
2774
Hose (blue), Pneumatic, 12 foot
(Adult/Pediatric Cuffs) 8841
Power Cord (Domestic) 8884
(International) 8885
Operation Manual 328-380
Optional Accessories Reorder No.
Not included as Standard
Accessories Re
g
ular
(White) Sterile
(White)
DISPOSA-CUF™Neonatal
Blood Pressure Cuffs
Neonatal #1, 3 cm-6 cm 2638 8311
Neonatal #2, 4 cm-8 cm 2633 8312
Neonatal #3, 6 cm-11 cm 2628 8313
Neonatal #4, 7 cm-13 cm 2623 8314
Neonatal #5, 8 cm-15 cm 2619

2-3
Optional Accessories Cont. Reorder No.
DISPOSA-CUF
™
Soft Neonatal
Blood Pressure Cuffs
Neonatal #1, 3 cm-6 cm 2521
Neonatal #2, 4 cm-8 cm 2522
Neonatal #3, 6 cm-11 cm 2523
Neonatal #4, 7 cm-13 cm 2524
Neonatal #5, 8 cm-15 cm 2525
DISPOSA-CUF™Disposable
Blood Pressure Cuffs Re
g
ular
(White
)
Infection
Control
(Yellow)
Infant 2618
Child 2613
Small Adult 2608 2607
Adult 2603 2602
Large Adult 2643 2642
Thigh 2648
DISPOSA-CUF™Soft
Disposable Blood Pressure
Cuffs
Infant 2500
Child 2501
Small Adult 2502
Adult 2503
Large Adult 2504
Thigh 2505
DURA-CUF™Bladderless
Blood Pressure Cuff
Infant, 8 cm-13 cm 2783 (Rust)
Child, 12 cm-19 cm 2781 (Green)
Small Adult,17 cm-25 cm 2779 (Royal Blue)
Adult, 23 cm-33 cm 2774 (Navy Blue)
Large Adult,31 cm-40 cm 2791 (Wine)
Thigh, 38 cm-50 cm 2796 (Brown)

2-4
Optional Accessories Cont. Reorder No.
Calibration Kit 8886
Hose (light blue), Pneumatic, 8
foot (Neonate Cuffs) 8840
Hose (blue), Pneumatic, 24 foot
(Adult/Pediatric only) 8842
Model 902 Mobile Stand 0902
DINAMAP
™
BP Accessory Pole 3207
DINAMAP™BP Accessory
Base 3208
DINAMAP™BP Accy. Basket 3209
Accessory Bag 1902
Writing Tablet Holder 8812
Writing Tablet (25 tablets/cs) 8811
Tympanic Thermometer
Conversion Kit 1402
P-81T Printer 8252
Service Manual 328-630
Note
The Calibration Kit is included as part of the
Service Manual.

3-1
SECTION 3. PHYSICAL DESCRIPTION
The DINAMAP™ Portable Monitor Model 8100 is a
microprocessor controlled noninvasive device housed in a
blue plastic case. Performance and technical specifications
for the Model 8100 follow. Tables 3-1 and 3-2 contain a
general physical description of the monitor's controls,
indicators, connectors, and operating requirements.
PERFORMANCE
SPECIFICATIONS CUFF PRESSURE RANGE Adult/Pediatric 0 mmHg to 250 mmHg
Neonate 0 mmHg to 235 mmHg
INITIAL CUFF INFLATION
Adult/Pediatric 178 ±15 mmHg
Neonate 125 ±15 mmHg
SYSTOLIC DETERMINATION
Adult/Pediatric (Maximum) 245 mmHg
(Minimum) 30 mmHg
Neonate (Maximum) 190 mmHg
(Minimum) 30 mmHg
MAP DETERMINATION
Adult/Pediatric (Maximum) 225 mmHg
(Minimum) 20 mmHg
Neonate (Maximum) 170 mmHg
(Minimum) 20 mmHg
DIASTOLIC DETERMINATION
Adult/Pediatric (Maximum) 210 mmHg
(Minimum) 10 mmHg
Neonate (Maximum) 160 mmHg
(Minimum) 10 mmHg
BLOOD PRESSURE ACCURACY
Blood Pressure accuracy meets and exceeds proposed
AAMI standards for non-invasive blood pressure accuracy.
(AAMI standard: ±5 mmHg mean error; 8 mmHg standard
deviation.)

3-2
PERFORMANCE
SPECIFICATIONS
Continued
PULSE RATE DETERMINATION
Adult/Pediatric (Maximum) 200 bpm
(Minimum) 40 bpm
Neonate (Maximum) 220 bpm
(Minimum) 40 bpm
PULSE RATE ACCURACY
±3.5 percent
DETERMINATION TIME
20 seconds to 45 seconds typical; 120 seconds maximum
OVERPRESSURE CUTOFF
Adult/Pediatric 300 ±30 mmHg
Neonate 235 ±10 mmHg
TECHNICAL
SPECIFICATIONS Mechanical DIMENSIONS
Height 8.8 inches
Width 6.7 inches
Depth 6.7 inches
WEIGHT
Approximately 8.6 pounds
COLOR
Blue case with black front panel
MOUNTINGS
Self-supporting on rubber feet or pole mountable.
PORTABILITY
Carrying handle recessed in top of monitor.
OPERATOR'S INSTRUCTIONS/ALARM INTERPRETATION
Abbreviated operator's instructions and alarm
interpretations are located on side panel labels.

3-3
TECHNICAL
SPECIFICATIONS(cont) Electrical POWER CABLE
Domestic–10 foot detachable blue-jacketed 16 gauge
terminated with 3-prong hospital grade plug.
International–10 foot detachable blue-jacketed 16-gauge
unterminated.
BATTERY
12 volt, 2.4 amp-hours. Six hour minimum operation (5
minute auto cycle w/adult cuff at 25 degrees C) with full
charge (see Table 6-1, Battery Charging Characteristics).
POWER REQUIREMENTS
Input Power
0.4 amps max. at 100, 120 VAC
0.2 amps max. at 220, 240 VAC
Input Voltage
(Domestic)
120 VAC/60 Hz (nom.), 104-132 VAC, 47-63 Hz
Note: Evaluations performed by UL/CSA are
applicable to 120V products only.
(International)
100 VAC/50 Hz (nom.), 88-112 VAC, 47-63 Hz
230 VAC/50 Hz (nom.), 194-268 VAC, 47-63 Hz
FUSE REQUIREMENTS
120 VAC/60 Hz–2 each, 0.5 amp, 3AG at 250 VAC
100 VAC/50 Hz–2 each, 0.5 amp, 3AG at 250 VAC
230 VAC/50 Hz–2 each, 0.25 amp, FST at 250 VAC
Environmental
OPERATING TEMPERATURE
+50°F to +104°F
+10°C to +40°C
STORAGE TEMPERATURE
-29°F to +167°F
-34°C to +75°C
HUMIDITY RANGE
0% to 95% noncondensing
ALTITUDE RANGE
-1000 feet to +15000 feet
BF SYMBOL: This symbol indicates the
classification of this type of equipment is in
compliance with IEC Publication 601-1 and BS
5724-1, Type BF.
ATTENTION: Consult accompanying
documents.

3-4
Figure 3-1. Model 8100 Front Panel Controls and Indicators
TABLE 3-1 MODEL 8100 FRONT PANEL CONTROLS AND
INDICATORS
ITE
M
NAME FUNCTION
1 CUFF This illuminated (amber) indicator
signifies that a determination is in
progress.
2 kPa kPa (amber) indicator lights only if
internal kPa jumper is installed.