Operating Manual
116 Pages
Preview
Page 1
VAULT COPY CHECKED & VERIFIED 10/21/2003
TABLE OF CONTENTS FOREWORD...
v
SAFETY CONSIDERATIONS...
vii
SAFETY DESIGNATIONS...
ix
PRODUCT LIMITATIONS...
x
UNPACKING...
xi
SYMBOLS AND DESCRIPTIONS...
xii
1.0
1-1
GENERAL DESCRIPTION... 1.1
2.0
General Description... 1-1 CONTROLS AND INDICATORS...
2-1
2.1
Front Panel... 2-2
2.2 2.3
Rear Pane... 2-12 Predictive Thermometer Module (PTM)... 2-13
2.4
Recorder Module... 2-14
3.0
OPERATION...
3-1
3.1
Setting-Up / Turning Power On... 3-1
3.2
Patient Setup and Room/Bed Assignment... 3-3
3.2.1
Selecting the Patient Size... 3-3
3.2.2
Cuff Inflation Pressure... 3-3
3.2.3
Room Number and Bed Letter... 3-4
3.3
Manual NIBP Measurements and General NIBP Measurement Information... 3-5
3.3.1
NIBP Pressure Limit Fail Safe... 3-7
3.3.2
Cuff Inflation Time... 3-7
3.3.3
Automatic Adjustment of Cuff Inflation Pressure (Adaptive Inflation)... 3-7
3.4
Automatic NIBP Measurements (Interval Mode)... 3-8
3.4.1
Canceling an Automatic NIBP Measurement... 3-9
3.4.2
Changing the Interval Setting... 3-9
3.4.3
Effects of Changing the Room Number and/or Bed Letter on the Interval Setting... 3-9
Accutorr Plus Operating Instructions Table of Contents
i
3.4.4
Start and Deflate Functions... 3-10
3.5
Alarms... 3-11
3.5.1
Setting Alarm Limits... 3-11
3.5.2
Alarm Violations... 3-13
3.5.3
How to Mute Alarms... 3-13
3.5.4
Alarms and Changing the Room Number and/or Bed Letter . . 3-14
3.6
To View and Delete Stored Data (Trend Mode)... 3-15
3.6.1
To View the Stored Measurements on the Accutorr Plus NIBP. . 3-15
3.6.2
To View the Stored Measurements on the Accutorr Plus NIBP with Trend Screen and the Accutorr Plus NIBP with Trend Screen and SpO 2... 3-16
3.6.3
To Delete Stored Measurements on all Models of the Accutorr Plus... 3-16
ii
3.7
Setting the Alarm Volume and Beep Volume... 3-18
3.8
Setting the LCD Contrast (View Angle Adjustment)... 3-19
3.9
Display Time Out Mode... 3-20
3.10
SpO2 Measurements (Accutorr Plus with SpO 2 only)... 3-21
3.10.1
Datascope Pulse Oximetry... 3-21
3.10.2
Nellcor® Pulse Oximetry... 3.26
3.10.3
Masimo® Pulse Oximetry... 3-30
3.11
Temperature Measurement (optional)... 3-34
3.11.1
Predictive Thermometer Measurements... 3-34
3.11.2
How to Apply Probe Cover (PTM)... 3-34
3.11.3
How to Take Oral, Rectal, and Axillary Temperatures... 3-35
3.11.4
Storing Temperature Measurements... 3-37
3.12
Recorder (optional)... 3-38
3.13
How to Set the Clock (Date and Time)... 3-39
3.14
Battery Operation... 3-40
3.15
User Configuration... 3-41
3.16
Status and Error Codes... 3-44
3.17
How to Attach Optional Thermometer and Recorder Modules . 3-46
3.18
Placement of the Quick Reference Card... 3-47
3.19
Placement of the Recorder Paper Loading Label... 3-48
Accutorr Plus Operating Instructions Table of Contents
4.0
USER MAINTENANCE...
4-1
4.1
Introduction... 4-1
4.2
Care and Cleaning of Monitor... 4-1
4.3
Sterilization and Cleaning of Reusable Cuffs... 4-2
4.4
Care and Cleaning of Datascope Flexisensors and Datasensors... 4-2
4.5
Battery Maintenance and Replacement... 4-3
4.5.1
Battery Maintenance... 4-3
4.5.2
Battery Replacement... 4-4
4.6
Recorder Paper Replacement... 4-5
4.7
Datascope Thermal Paper Durability... 4-6
5.0
ACCESSORIES...
5-1
6.0
APPENDIX...
6-1
6.1
How to Get Help... 6-1
6.2
Specifications... 6-3
6.3
Electromagnetic Compatibility... 6-13
6.4
Indirect Blood Pressure Measurements and Associated Errors . 6-14
6.5
Precautions with Using Automatically Cycled Blood Pressure Cuffs... 6-15
6.6
User Verification of the Accutorr Plus NIBP Measurements . . . 6-16
6.7
Warranty... 6-16
6.8
Datascope’s Responsibility... 6-17
DECLARATION OF CONFORMITY...
Accutorr Plus Operating Instructions Table of Contents
6-18
iii
FOREWORD This operating instructions (0070-00-0428) is intended to provide information for the proper operation of the Datascope Accutorr Plus. This manual describes 5 models of the Accutorr Plus. Each model is available with either Sealed Lead Acid or Lithium Ion Battery technology. One is a basic model, the Accutorr Plus NIBP which measures NIBP and Pulse Rate. The second model, is the Accutorr Plus NIBP with Trend Screen, which incorporates a Liquid Crystal Display (LCD). The third, fourth and fifth models, are the Accutorr Plus NIBP with Trend Screen and SpO2 which also incorporates the LCD and adds SpO2 (Datascope, Nellcor, or Masimo). In this manual, when a described feature refers to a particular model, it will be noted. When the name Accutorr Plus is used, it refers to all 5 models. General knowledge of monitoring and an understanding of the features and functions of the Datascope Accutorr Plus are prerequisites for its proper use. DO NOT OPERATE THIS UNIT BEFORE READING ALL INSTRUCTIONS. Information for servicing this instrument is contained in the Datascope Accutorr Plus Service Manual, Part No. 0070-00-0429 (0998-00-0444-XX/-LXX), 0070-00-0543 (0998-00-0444-CXX/-JXX). For additional information or assistance, please contact an authorized Datascope representative in your area. U.S. Federal Law restricts this device to sale by or on the order of a physician or other practitioner licensed by state law to use or order the use of this device. NOTE: In order to ensure the proper performance and to prevent the voiding of the warranty, only parts and accessories provided by Datascope are to be used with the Accutorr Plus. Datascope maintains a policy of continual product improvement and reserves the right to change materials and specifications without notice. Masimo Patents: This device (MASIMO SpO2 Module) is covered under one or more of the following U.S. Patents 5,482,036, 5,490,505, 5,632,272, 5,685,299, 5,758,644 and 5,769,785, 6,002,952, 6,036,642, 6,067,462, 6,157,850 and 6,206,830. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device.
Accutorr Plus Operating Instructions Introduction
v
Nellcor Patents: This device (Nellcor SpO2 Module) is covered under one or more of the following U.S. Patents 4,621,643, 4,653,498, 4,700,708, 4,770,179, 4,802,486, 4,869,254, 4, 928,692, 4,934,372, 5,078,136, 5,351,685, 5,421,329, 5,485,847, 5,533,507, 8,577,500, 5,803,910, 5,853,364, 5,865,736, 6,083,172, Re. 35, 122. Possession or purchase of this device does not convey any express or implied license to use the device with replacement parts which would, alone, or in combination with this device, fall within the scope of one or more of the patents relating to this device. NOTE: This product is year 2000 compliant.
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Accutorr Plus Operating Instructions Introduction
SAFETY CONSIDERATIONS Please read and adhere to the following safety considerations regarding the use of this instrument: Internal Electrical Shock Hazard - This unit does not contain any user-serviceable parts. Do not remove instrument covers. Refer servicing to qualified personnel. When the integrity of the protective earth conductor, in the installation or its arrangement, is in doubt, the equipment should be operated from its internal battery. Observe all CAUTION and WARNING labels on the unit. Communications Connector - Connection of non-isolated devices to the Communications Connector on this unit may cause chassis leakage to exceed the specification standards. Always place the unit on a flat, rigid surface or onto a stable mounting pole. Never place fluids on top of this unit. In case of accidental wetting, remove power, dry it immediately and have the unit serviced to insure no hazard exists. If fluid spills on the unit or if the unit is damaged, refer to qualified service personnel. The NIBP connection is protected against the effects of a defibrillator discharge. Observe extreme caution when a defibrillator is in use. Do not touch any part of the patient, table or monitor when a defibrillator is in use. NIBP cuffs used with this product contain natural rubber latex which may cause allergic reactions. The unit should be checked periodically for obstructed vents. If an obstruction is found refer to qualified service personnel. Do not leave the patient unattended for long periods of time while using this instrument. Use only Datascope approved accessories with this product. Use of other accessories may result in erroneous readings. This instrument may have trouble obtaining pulse rate and NIBP readings on patients undergoing intra-aortic balloon pump treatment. Wrapping the cuffs too tightly may cause a hazard to the patient.
Accutorr Plus Operating Instructions Introduction
vii
NOTE: Potential hazards due to errors in software or hardware have been minimized by actions taken in accordance with IEC 60601-1-4. The Accutorr Plus is not intended for use in a magnetic resonance imaging (MRI) environment and may interfere with MRI procedures.
viii
Accutorr Plus Operating Instructions Introduction
Safety Designations Safety designations per IEC 601-1 Standard: Type of protection against electric shock
Class 1 and Internal Power Source. Where the integrity of the external protective earth in installation or its conductor arrangement is in doubt, equipment shall be operated from its internal power source
Degree of protection against electric shock
SPO2, Type BF NIBP, Type BF Monitor, Type B
Supply Connection
100-120 VAC / 220-240 VAC 50-60 Hz; 0.6 / 0.3 A 12 VDC Lead Acid or 10.8 VDC Lithium Ion Internal Battery
Mode of Operation
Continuous
Protection Against Hazardous of Explosion Protection Against Ingress of Liquids
Not Protected (Ordinary)
Degree of Electrical Connection Between Equipment and Patient
Equipment designed for direct electrical and non-electrical connection to the patient.
Degree of Mobility
Mobile and/or hand held
Accutorr Plus Operating Instructions Introduction
Not Protected (Ordinary)
ix
PRODUCT LIMITATIONS Non-invasive blood pressure (NIBP) accuracy depends on the application of the proper cuff size. See Section 3.3 for detailed information. The Accutorr Plus will not operate effectively on patients who are experiencing convulsions or tremors. The Accutorr Plus is a portable device intended for intra-hospital use. If the pressure cuff is not placed at the patient’s heart level, the NIBP measurement may be subject to error, due to the hydrostatic effect. The pulse rate data displayed on the Datascope Accutorr Plus is computed from the measurement of peripheral pulses (peripheral pulses taken only during a measurement cycle). The rate measured by the Datascope Accutorr Plus may differ from the rate of an ECG monitor. This is because the ECG is an electrical signal that may not always result in a peripheral pulse. Administration of certain vasoconstrictive drugs (for example, norepinephrine), may reduce peripheral perfusion to a level that prevents the Accutorr Plus from taking pulse rate measurements. Arterial compression, tricuspid regurgitation, or other conditions may reduce perfusion to a level that prevents the Accutorr Plus from taking pulse rate measurements. The presence of arrhythmias may increase the time required to complete a measurement and may extend this time to a point where a measurement cannot be completed.
The Datascope Accutorr Plus is not intended for use during CPR. The monitor uses an oscillometric technique based on normal peripheral circulation to compute blood pressure. On occasion, increased motion, prolonged crying, or hyperactivity may produce measurements with a status code of 8810 (RETRY-UNABLE TO MEASURE) or 8813 (STOP-UNABLE TO MEASURE). See section 3.16 for a list of status and error codes.
x
Accutorr Plus Operating Instructions Introduction
UNPACKING Remove the instrument from the shipping carton and examine it for signs of shipping damage. Save all packing materials, invoice, and bill of lading. These may be required to process a claim with the carrier. Check all materials against the packing list. Contact the Datascope Customer Service Department (800) 288-2121 or (201) 265-8800 for prompt assistance in resolving shipping problems.
Copyright © Datascope Corp., 1999. Printed in U.S.A. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Datascope Corp.
Accutorr Plus Operating Instructions Introduction
xi
SYMBOLS AND DESCRIPTIONS Most of the symbols in the table below are defined in the IEC Publication 878 and ISO Standard 7000. These symbols are used on all models of the Accutorr Plus.
xii
Accutorr Plus Operating Instructions Introduction
1.0 GENERAL DESCRIPTION 1.1 General Description
N IBP
SY S.
START NIBP
PATIENT SETUP
DEFLATE
DIA .
INTERVAL
TIM ER/ TEM P
INTERVAL ELAP. TIME TEMP
A LA RM S
NIBP
MUTE
SET ALARMS
PA TI EN T IN FO .
RO O M BED
Sp02
SpO 2
DATA SCAN BED
DELETE INFO . MEMORY FULL
20/05 20/05 20/05 20/05 20/05
03:00 02:58 02:35 02:33 02:30
MEN U
S / D / M 114/64 83 61 123/61 84 60 127/62 83 58 185/105 135 56 129/62 84 59 SELECT
PRI NT
HOLD TOCLEAR.
o F/C %SPO2 98.7 96 98.5 97 97.6 96 96 ---98.2 97
DEFAULTS
ON STANDBY
Figure 1-1 The Datascope Accutorr Plus NIBP with Trend Screen and Datascope SpO2 with the Recorder Module The Datascope Accutorr Plus is available in 5 models. They are, the Accutorr Plus NIBP, the Accutorr Plus NIBP with Trend Screen and the Accutorr Plus NIBP with Trend Screen and SpO 2 (Datascope, Nellcor, or Masimo). Each model is available with either a Lithium Ion or Sealed Lead Acid Battery Technology. The Accutorr Plus NIBP measures non-invasive blood pressure (NIBP) and pulse rate. The Accutorr Plus with Trend Screen incorporates a liquid crystal display (LCD). The LCD is used to view stored measurements (trend) and to access a menu system which is used to set the alarm volume and the SpO2 beep volume. The Accutorr Plus with Trend Screen and SpO2 adds the automatic SpO 2 measurement function with your choice of Datascope, Nellcor, or Masimo SpO2. In this manual, when a feature is described and it only refers to a particular model, it will be noted. When the name Accutorr Plus is used, it refers to all 5 models. Accutorr Plus Operating Instructions Chapter 1 - General Description
1-1
On all units temperature can be measured with the optional Predictive Thermometer Module (PTM) or the optional AccuTemp IR Infrared Thermometer Module. All units can also be optionally equipped with a recorder module for documenting NIBP, pulse rate, SpO2 and temperature information. Each printout includes the time and date of each measurement taken. The Accutorr Plus can store up to 100 measurements in memory. These 100 measurements are shared by the number of patients that are monitored by the Accutorr Plus. When only one patient is monitored, then that one patient can have up to 100 measurements stored. When more than one patient is monitored each patient can have any number of measurements stored as long as the total number of stored measurements for all patients equals 100 or less. The Accutorr Plus features front panel digital displays for Mean Arterial Pressures, Temperature and Time and extra large displays for the Systolic, Diastolic, Pulse Rate and SpO 2. The Accutorr Plus models with Trend Screen incorporate a Liquid Crystal Display (LCD) for viewing trend data. The Accutorr Plus has an Interval Mode which enables the unit to take automatic NIBP measurements at timed intervals. The Accutorr Plus allows setting of alarm limits. All alarm violations are indicated by an audible alarm tone, flashing front panel displays and brackets around the violated parameter on the recorder print outs. The Accutorr Plus also has the capability of operating from a battery. Some key features of the Accutorr Plus are:
• Non-Invasive Blood Pressure (NIBP) • Pulse Rate • Datascope, Nellcor, or Masimo SpO 2 (Model with SpO 2 only) • Alarms • Interval Mode • Large Light Emitting Diode (LED) Displays • Trend Memory - Up to 100 Measurements • Communications - Datascope Improved ASCII Protocol (DIAP) • Universal Power Supply
1-2
Accutorr Plus Operating Instructions Chapter 1 - General Description
• Automatic Power Saver • User Configured Settings • Thermometry, PTM or AccuTemp IR (Optional) • Recorder (Optional) • High Contrast LCD (Models with Trend Screen only) • Customer Replaceable Battery (Sealed Lead Acid or Lithium Ion) • Universal mounting adapter for rolling stands and wall mounts
Accutorr Plus Operating Instructions Chapter 1 - General Description
1-3
2.0 CONTROLS AND INDICATORS This section of the Operating Instructions identifies and describes each control and display of the Datascope Accutorr Plus NIBP, the Accutorr Plus NIBP with Trend Screen and the Accutorr Plus NIBP with Trend Screen and SpO2 . For step-by-step operating instructions see Chapter 3, “Operation”. The following is a list of all controls, connectors and indicators, their item number and the page number. The item number refers to the call outs on the drawings within this chapter. The page number refers to the page where the description of the item can be found. CONTROL FRONT PANEL
Page
CONTROL 29. Set Alarms Key
Page 2-9
1.
NIBP Systolic Display
2-6
2.
NIBP Diastolic Display
2-6
30. 31.
Mute Key Mute Indicator
2-10 2-10
3.
NIBP MAP Display
2-6
4.
Pulse Rate Display
2-6
32. 33.
Timer/Temp Key Interval/Elap. Time/Temp Display
2-10 2-10
34. 35.
Interval Key Interval Indicator
2-10 2-11
36. 37.
Deflate Key Patient Setup Key
2-11 2-11
38. 39.
Start NIBP Key Start NIBP Indicator
2-11 2-11
40. 41.
Patient Size Indicators Hidden Key
2-11 2-11
5.
NIBP/SpO2 Pulse Rate Indicator
2-6
6.
SpO2 Display
2-6
7.
Liquid Crystal Display (LCD)
2-6
8.
Menu Key
2-6
9.
LCD Up Arrow Key
2-7
10.
LCD Down Arrow Key
2-7
11.
Select Key
2-7
12.
Print Key
2-7
13.
Print Indicator
2-7
14.
Defaults Key
2-7
15.
Datascope, Nellcor®, or Masimo® SpO2 Connector
16. 17.
AC Power Indicator Battery Indicator
18. 19.
REAR PANEL
2-7
42. 43.
Thermometer Module Connector Equipotential Lug
2-12 2-12
2-7 2-8
44. 45.
AC Power Connector Communications Connector
2-12 2-12
NIBP Connector On/Standby Key
2-8 2-8
46. 47.
Datascope Connector Pole Mounting Handle and Cam
2-12 2-12
20. 21.
Memory Full Indicator Delete Info. Key
2-8 2-8
48.
Recorder Module Connector
2-12
22. 23.
Data Scan Key Data Scan Indicator
2-8 2-9
24. 25.
Room/Bed Key Bed Letter Display
2-9 2-9
26. 27.
Room Number Display Patient Info. Down Arrow Key
2-9 2-9
RECORDER MODULE 52.
Paper Door
2-14
2-9
53.
Paper Tear Edge
2-14
28.
Patient Info. Up Arrow Key
Accutorr Plus Operating Instructions Chapter 2, Controls and Indicators
PREDICTIVE THERMOMETER MODULE 49. 50.
Probe Cover Holder Probe Chamber
2-13 2-13
51.
Probe Connector
2-13
2-1
2.1 Front Panel
41
40
1 NIBP
39
SYS.
38
START NIBP
37
2 PATIENT SETUP
DIA.
36
DEFLATE
35 34
INTERVAL
3 TIMER/TEMP
33
4 32 MAP
5
INTERVAL
ELAP. TIME
30 29
SET ALARMS
MUTE
6
31
TEMP
ALARMS
NIBP
28 26
Sp 0 2
27 25
SpO2
ROOM BED
PATIENT INFO.
24
DATA SCAN
7
ROOM
BED
DELETE INFO.
MEMORY FULL
20/05 20/05 20/05 20/05 20/05
8
S/D/M 114/64 83 61 123/61 84 60 127/62 83 58 185/105 135 56 129/62 84 59
03:00 02:58 02:35 02:33 02:30
MENU
SELECT
22
23
21 20
ON STANDBY
DEFAULTS
PRIN T
HOLD TO C LEAR.
F/C %SPO2 98.7 96 98.5 97 96 97.6 96 ---98.2 97
o
19
9
10
11
12
13
14
15
16
17
18
Figure 2-1 Front Panel - Accutorr Plus NIBP with Trend Screen and Datascope SpO2
2-2
Accutorr Plus Operating Instructions Chapter 2, Controls and Indicators
40
41
1 NIBP
39
SYS.
START NIBP
38
DEFLATE
36
INTERVAL
34
37
2 PATIENT SETUP
3
35
DIA. TIMER/TEMP
33
4 32
M AP
5
INTERVALELAP . TIME TEMP
6
31 30
ALARMS
NIBP
MUTE
SET ALARMS
29 28 27 26 25
PATIENT INFO.
ROOM BED
24
Sp02
SpO 2
DATA SCAN ROOM
7
BED
DELETE INF O. MEMO RY FULL HOLD TO CL EAR.
20/05 20/05 20/05 20/05 20/05
8
03:00 02:58 02:35 02:33 02:30
MENU
S/D/M 114/64 83 61 123/61 84 60 127/62 83 58 185/105 135 56 129/62 84 59 SELECT
22
o
F/C %SPO2 98.7 96 98.5 97 97.6 96 96 ---98.2 97
23
21 20
ON STANDBY
DEFAULTS
19
9
10
11
12
13
14
15
16
17
18
Figure 2-2 Front Panel - Accutorr Plus NIBP with Trend Screen and Nellcor® or Masimo® SpO2
Accutorr Plus Operating Instructions Chapter 2, Controls and Indicators
2-3
40
41
1 NIBP
39
SYS.
START NIBP
38
DEFLATE
36
INTERVAL
34
37
2 PATIENT SETUP
35
DIA. 3 TIMER/TEMP
4
33 32
MAP
5
INTER VAL
ELAP.TIME
31
TEMP
ALARMS
NIBP
30 29
SET ALARMS
MUTE
28 26
27 25
ROOM BED
PATIENT INFO.
24
DATA SCAN
7
ROOM
20/05 20/05 20/05 20/05 20/05
8
S/D /M 114/64 83 61 123/61 84 60 127/62 83 58 185/105 135 56 129/62 84 59
03:00 02:58 02:35 02:33 02:30
MENU
SELECT
BED
DELETE INFO.
MEMORY FULL
HOLDTO CLEAR.
22
F/C %SPO2 98.7 96 98.5 97 96 97.6 96 ---98.2 97
o
23
21 20
ON STANDBY
DEFAULTS
19
9
10
11
12
13
14
16
17
18
Figure 2-3 Front Panel - Accutorr Plus NIBP with Trend Screen
2-4
Accutorr Plus Operating Instructions Chapter 2, Controls and Indicators
40
41
1 NIBP
39
SYS.
38
START NIBP
37
2 PATIENT SETUP
36
DEFLATE
DIA.
35 34
INTERVAL
3 TIMER/TEMP
33
4 32 5
INTERVAL
ELAP.TIME
TEMP
30
ALARMS
NIBP
29
SET ALARMS
MUTE
31
28 26
27 25
ROOM BED
PATIENT INFO.
24
DATA SCAN ROOM
BED
DELETE INFO.
MEMORY FULL
HOLD TOCLEAR.
22
23
21 20
ON
DEFAULTS
STANDBY
19
12
13
14
16
17
18
Figure 2-4 Front Panel - Accutorr Plus NIBP
Accutorr Plus Operating Instructions Chapter 2, Controls and Indicators
2-5