Operators Manual
196 Pages
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GE Healthcare
MAC® 5500/MAC® 5500 HD Resting ECG Analysis System Operator's Manual Software Version 10 2046275-016 Revision A
MAC® 5500/MAC® 5500 HD Resting ECG Analysis System English 2010 General Electric Company. All Rights Reserved.
Publication Information The information in this manual only applies to MAC® 5500 and MAC® 5500 HD system software version 10. It does not apply to earlier software versions. Due to continuing product innovation, specifications in this manual are subject to change without notice. MAC, MULTI-LINK, MUSE, MACTRODE, Ultra-Archivist, MobileLink, and 12SL are trademarks owned by GE Medical Systems Information Technologies, Inc., a General Electric Company going to market as GE Healthcare. All other marks are the properties of their respective owners. This product complies with the regulatory requirements concerning medical devices from the following bodies:
The document part number and revision appear at the bottom of each page. The revision identifies the document’s update level. The revision history of this document is summarized in the following table.
Revision History Revision
Publication Date
Description
A
29 October 2010
Initial release of the document.
To access other GE Healthcare manuals, go to the Common Documentation Library (CDL), located at http://www.gehealthcare.com/usen/ service/biomed_tech_selfservice/services_user_doc/products/support.html and click Cardiology.
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MAC® 5500/MAC® 5500 HD
2046275-016A 29 October 2010
Contents
1
Introduction Product Information... 9 Indications for Use... 9 Prescription Device Statement... 9 Recording ECGs During Defibrillation... 9 Accuracy Of the Input Signal Reproduction... 10 Modulating Effects in Digital Systems... 10 Installation and Connection... 10 Parts and Accessories... 10 Equipment Symbols... 17 Product and Packaging Labeling... 19 Equipment Identification... 22
Regulatory and Safety Information... 24 Safety Conventions... 24 Safety Messages... 24 Classification... 28 Underwriters Laboratories, Inc... 28 EMI/EMC Requirements... 28 Legal Notice... 29 Responsibility of the Manufacturer... 29 Responsibility of the Purchaser/Customer... 29
Service Information... 29 Service Requirements... 29 Additional Assistance... 29
Manual Information ... 30 Manual Purpose... 30 Intended Audience... 30 Document Conventions... 30 Related Documentation... 31 Training... 31
2
System Overview Hardware Description ... 33 Front View... 33 Back View... 34 Internal View... 34 Back Panel... 35 Keyboard - Standard Keys... 36 Keyboard - Exercise Test Keys (Option)... 37
Acquisition Equipment ... 38 Acquisition Module... 38 Leadwire Labels... 39 Leadwire Adapters... 40
Connecting Peripherals... 40 Connecting the LAN Option... 41 2046275-016A
MAC® 5500/MAC® 5500 HD
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Connecting the Modem Option... 41 Connecting the MobileLink Wireless Option... 41 Connecting External Exercise Devices... 41 Connecting the Acquisition Device... 41 Verifying Correct Operation... 42
Software Overview... 42 Test Screens... 42 Main Menu... 45 Report Layout... 48 Entering Data... 50
3
Preparing the Patient Preparing the Patient's Skin ... 54 Electrode Placement ... 55 Resting ECG Placement... 55 Exercise ECG Placement... 60
4
Entering Patient Information Manually Entering Patient Information... 64 Reading a Patient Card (Option)... 64 Connecting the Card Reader... 65 Reading a Patient ID Card... 65
Scanning a Bar Code (Option) ... 66 Connecting the Bar Code Scanner... 66 Scanning the Bar Code... 66
Entering Orders... 67 Receiving Orders from a MUSE CV System (Option)... 67 Manually Entering Orders... 69 Selecting and Completing Orders... 69
5
Recording an ECG Hookup Advisor ... 71 Standard ECGs ... 73 Signal Averaged ECGs ... 75 Master's Step ECGs ... 76
6
Exercise Stress Testing Starting a Stress Test ... 77 Pretest Phase ... 78 Exercise Phase... 79 Recovery Phase ... 81
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Test End Phase ... 81
7
Editing Protocols Protocol Overview... 83 Editing or Creating Protocols ... 85
8
Printing ECG Reports Printing Another Report ... 89 Printing Stored ECGs ... 89 Storing Printouts... 90
9
Transmitting ECGs Transmitting ECGs via Modem ... 91 Transmitting ECGs Locally ... 92 Transmitting ECGs Wirelessly ... 93 Transmitting ECGs in XML Format... 94
10
Receiving ECGs Receiving ECGs from Another MAC System... 95 Receiving ECGs via Modem... 95 Receiving ECGs Locally... 96
Receiving ECGs from a MUSE CV System... 96
11
Editing ECGs Editing Demographic Information ... 99 Editing ECG Measurements... 100 Editing Interpretive Statements... 101
12
Deleting ECGs and Orders Deleting ECGs... 103 Deleting Orders... 104
13
Using an SD Card Supported SD Cards ... 107 Preparing the SD Card... 108
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Locking and Unlocking the SD Card... 108 Inserting and Ejecting the SD Card... 108 Formatting the SD Card... 108
Managing Files on the SD Card ... 109 Displaying Stored ECGs... 109 Copying Files to the SD Card... 109 Restoring Files from the SD Card... 110 Saving Files in XML Format... 110
Updating Software from the SD Card... 111
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System Setup System Setup Hierarchy... 113 Process Overview... 115 Setting Up Automatic Tasks ... 116 Setting Up Power Up Function... 116 Setting Up ECG Preview... 116 Setting Up Resting ECG Report Printing... 117 Setting Up Automatic ECG Storing... 117 Setting Up Automatic ECG Transmission... 118 Setting Up Signal Averaged ECG Report Printing... 118 Setting Up ACI-TIPI Interpretation... 118
Setting Up System Basics... 119 Miscellaneous Setup... 119 Patient Questions... 121 Screen Colors... 124 Transmission... 124 Network Settings... 126 Option Activation... 126 Date and Time... 128 Language... 128 Power Up Options... 129 Order Manager Interface... 129 Input Method... 130
Setting Up ECGs ... 131 ECG Acquisition... 131 ECG Analysis... 133 Patient Questions... 134 Writer Setup... 135 ECG Reports... 135 Analog Outputs... 141 CT Data Guard... 142 Critical Values Setup... 143
Setting Up Signal Averaged ECGs... 146 Setting Up Exercise Tests ... 146 Miscellaneous Setup... 147 Patient Questions... 147 Writer Setup... 148 Exercise Reports... 148 Screen... 153 Inputs and Outputs... 153
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Hi-Res... 155 Setting Up a Card Reader... 156 Automatic Configuration... 157 Manual Configuration... 157
Setting Up a Bar Code Reader ... 158 Automatic Configuration... 158 Manual Configuration... 158
Setting Up Master's Step Test ... 159 Managing System Setup ... 160 Printing System Setup... 160 Saving System Setup... 160 Restoring System Setup... 160
A
Maintenance Inspecting and Cleaning the MAC System... 163 Inspecting the MAC System... 163 Cleaning and Disinfecting Exterior Surfaces... 164 Cleaning, Disinfecting, and Storing ECG Cables and Leadwires... 165 Cleaning, Disinfecting, and Storing Handheld Devices... 167
Paper Maintenance ... 170 Setting the Correct Paper Size... 170 Loading the Paper... 171
Battery Maintenance ... 172 Charging the Battery... 172 Conditioning the Battery... 173 Replacing the Battery... 173
Replacing Leadwire Adapters ... 174
B
Troubleshooting General Troubleshooting Guidelines... 177 Visual Inspection ... 177 Performance Problems... 177 Unacceptable Noise Levels... 177 ACI-TIPI Report Does Not Print... 178 External Device Does Not Record BP Readings... 178 Treadmill/Ergometer Does Not Move... 178
System Errors... 179
C
Report Formats Numeric Reports ... 181 Additional Reports ... 182 In-Test Reports... 183
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Exercise Final Reports ... 184 Exercise Report Codes... 185
D
Master's Step Data Master's Step Table ... 187 ST-T Changes ... 190
E
Creating Bar Codes and Magnetic Cards Manual Reader Configuration... 191 Automatic Reader Configuration ... 193
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1
Introduction
This chapter provides information required for the proper use of the product and manual. Familiarize yourself with this information before using the product.
Product Information This section provides a general overview of the product. A detailed description of the product can be found in Chapter 2, System Overview.
Indications for Use The MAC 5500/5500 HD ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 lead ECG’s, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional. The MAC 5500 HD is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.
Prescription Device Statement CAUTION: United States federal law restricts this device to sale by or on the order of a physician.
Recording ECGs During Defibrillation This equipment is protected against the effects of cardiac defibrillator discharge to ensure recovery, as required by test standards. The patient signal input of the acquisition module is defibrillation-proof. Therefore, it is not necessary to remove the ECG electrodes prior to defibrillation. When using stainless steel or silver electrodes a defibrillator discharge current may cause the electrodes to retain a residual charge causing a polarization or dc offset voltage. This electrode polarization will block acquisition of the ECG signal. To avoid this condition, use non-polarizing electrodes (which will not form a dc offset voltage when subjected to a dc current) such as silver/silver-chloride types if there is a situation where there is a likelihood that a defibrillation procedure will be necessary. 2046275-016A
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If polarizing electrodes are used, we recommend disconnecting the leadwires from the patient before delivering the shock. Electrode defibrillation recovery is the ability of the electrode to allow the ECG trace to return after defibrillation. We recommend using non-polarizing disposable electrodes with defibrillation recovery ratings as specified in AAMI EC12 4.2.2.4. (Refer to “Parts and Accessories” on page 10 for a list of approved electrodes.) AAMI EC12 requires that the polarization potential of an electrode pair does not exceed 100mV, 5 seconds after a defibrillation discharge.
Accuracy Of the Input Signal Reproduction • Overall System Error meets AAMI EC11 3.2.7.1. Overall System Error is between or within +/–5%. • Frequency Response meets AAMI EC11 3.2.7.2 methods A and D. Frequency response is between or within +/- 10% between 0.67 and 40 Hz and between +0 and -10% for 20 ms, 1.5 mV triangular input.
Modulating Effects in Digital Systems This device uses digital sampling techniques that may produce some variation in amplitudes of Q, R, and/or S waves from one heart beat to the next, which may be particularly noticeable in pediatric recordings. If this phenomenon is observed, the clinician should be aware that the origin of amplitude variations is not entirely physiologic. For measuring voltages of Q, R, and S waves, it is advisable to use the QRS complexes with the largest deflection of the particular waves.
Installation and Connection If the installation of this equipment, in the USA, will use 240 V rather than 120 V, the source must be a center-tapped, 240 V, single-phase circuit. Contact GE Healthcare for information before connecting any devices to this equipment not recommended in this manual.
Parts and Accessories To ensure patient safety, use only parts and accessories manufactured or recommended by GE Healthcare. Parts and accessories used must meet the requirements of the applicable IEC 601 series safety standards, and/or the system configuration must meet the requirements of the IEC 60601-1-1 medical electrical systems standard. The use of ACCESSORY equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: • use of the accessory in the patient vicinity; and • evidence that the safety certification of the accessories has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard. The following sections identify the parts and accessories approved for use with this device. Not all items have been approved for use in all countries. Please check with your local GE Healthcare representative for country availability. 10
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Introduction
Electrodes The following non-polarizing electrodes have been approved for use with this device. Electrodes Part Number
Description
21714401
Suction Bulb Electrode, Thorax Electrode
42101600
Blue Suction Bulb
91920031
SilverTRACE ECG Electrodes, Soft P55MO, foam round, wet gel, 25/pouch, 200/box
2014780-001
SilverTRACE ECG Electrodes, Soft Stress PS50MO, foam round, wet gel, 30/pouch, 300/box
2014783-001
SilverTRACE ECG Electrodes, Window P50TR, clear tape round, solid gel, 30/pouch, 300/box
2014784-001
SilverTRACE ECG Electrodes, Window P50TR, clear tape round, solid gel, 5/strip, 300/box
2014785-001
SilverTRACE ECG Electrodes, Window P50TR, clear tape round, solid gel, 7/strip, 350/box
2014786-001
SilverTRACE ECG Electrodes, First Carbon P28MOC, foam rectangle, wet gel, carbon snap, 30/pouch, 300/box
2046545-001
ECG Electrode, Wet Gel P28 MOC, SilverTRACE Electrodes, 30/pack
402207-210
BabyMAC Electrodes, Resting ECG Electrodes, 10/card, 50/pack, 500/case
5608-003
GE Gray Suction Bulb
900703-205
SilverTRACE Ag/AgCl Electrodes, Adult Holter/Stress Electrode, Foam Oval, Wet Gel, 5/pkg, 150/box, 600/case
900703-230
SilverTRACE Ag/AgCl Electrodes, Adult Holter/Stress Electrode, Foam Oval, Wet Gel, 30/pouch, 300/case
9033-015
GE Suction Electrode & Gray Bulb
9623-003
Silver Mactrode Resting ECG Electrodes, 10/card, 100/pack, 1000/case
9623-003P
Silver Mactrode Plus Resting ECG Electrodes, 10/card, 100/pack, 1000/case
9623-103P
Silver Mactrode Plus Resting ECG Electrodes, 14/card, 140/pack, 1400/case
Leadwires The following leadwires have been approved for use with this device. Leadwires
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Part Number
Description
2001925-003
CAM 14 ECG Leadwire, Universal, 40 in (102 cm)
2001925-004
CAM 14 ECG Leadwire, Universal, 51 in (130 cm) MAC® 5500/MAC® 5500 HD
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Introduction
Leadwires (cont'd.)
12
Part Number
Description
2001925-005
CAM 14 ECG Leadwire, Universal,26 in (66 cm)
2001925-006
CAM 14 ECG Leadwire, Universal, 36 in (90 cm)
2016032-001
CAM 14 Leadwire Set, Dedicated Banana, AHA, 10/set, mixed lengths
2016032-002
CAM 14 Leadwire Set, Dedicated Banana, IEC, 10/set, mixed lengths
2016033-001
CAM 14 Leadwire Set, Dedicated Banana, AHA, 14/set, mixed lengths
2016033-002
CAM 14 Leadwire Set, Dedicated Banana, IEC, 14/set, mixed lengths
2020558-001
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 36 in (90 cm), RA
2020558-002
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 36 in (90 cm), LA
2020558-003
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 40 in (102 cm), LL
2020558-004
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 40 in (102 cm), RL
2020558-005
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), V1
2020558-006
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), V2
2020558-007
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), V3
2020558-008
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), V4
2020558-009
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), V5
2020558-010
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), V6
2020558-011
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), V3R
2020558-012
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), V4R
2020558-013
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), V7
2020558-014
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), E
2020558-015
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), H
2020558-016
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), I
2020558-017
CAM 14 ECG Leadwire, Dedicated Banana, AHA, 26 in (66 cm), M
2020559-001
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 36 in (90 cm), R
2020559-002
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 36 in (90 cm), L
2020559-003
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 40 in (102 cm), F
2020559-004
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 40 in (102 cm), N
2020559-005
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), C1
2020559-006
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), C2
2020559-007
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), C3
2020559-008
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), C4
2020559-009
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), C5
2020559-010
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), C6
2020559-011
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), E MAC® 5500/MAC® 5500 HD
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Introduction
Leadwires (cont'd.) Part Number
Description
2020559-012
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), H
2020559-013
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), I
2020559-014
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), M
2020559-015
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), C3R
2020559-016
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), C4R
2020559-017
CAM 14 ECG Leadwire, Dedicated Banana, IEC, 26 in (66 cm), C7
420101-001
CAM 14 ECG Leadwire Set, Universal, mixed length, 14/set
420101-002
CAM 14 ECG Leadwire Set, Universal, mixed length, 10/set
Leadwire Accessories The following electrode accessories have been approved for use with this device. Leadwire Accessories Part Number
Description
2001926-001
Blank Plug Kit, CAM 14, 4/bag
401089-003
Leadwire Organizers, 4 3-L Separators, 2 4-L Separators
414763-002
Multi-Link Leadwire Separator, 3-L, 3/pack
ECG Adapters and Connectors The following adapters and connectors have been approved for use with this device. ECG Adapters and Connectors
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Part Number
Description
406551-033
CAM 14 ECG Connector, Mactrode, V3R, AHA
406551-034
CAM 14 ECG Connector, Mactrode, V4R, AHA
406551-035
CAM 14 ECG Connector, Mactrode, V7, AHA
406554-033
CAM 14 ECG Connector, Banana, V3R, AHA
406554-034
CAM 14 ECG Connector, Banana, V4R, AHA
406554-035
CAM 14 ECG Connector, Banana, V7, AHA
900178-001
CAM 14 ECG Connector Set, Banana, 10/set, AHA
900178-002
CAM 14 ECG Connector Set, Mactrode, 10/set, AHA
900178-003
CAM 14 ECG Connector Set, Grabber, 10/set, AHA
900178-101
CAM 14 ECG Connector Set, Banana, 10/set, IEC
900178-102
CAM 14 ECG Connector Set, Mactrode, 10/set, IEC
900178-103
CAM 14 ECG Connector Set, Grabber, 10/set, IEC
900178-201
CAM 14 ECG Connector Set, Banana, 14/set, IEC MAC® 5500/MAC® 5500 HD
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Introduction
ECG Adapters and Connectors (cont'd.) Part Number
Description
900178-202
CAM 14 ECG Connector Set, Mactrode, 14/set, IEC
900178-203
CAM 14 ECG Connector Set, Grabber, 14/set, IEC
900179-201
CAM 14 ECG Connector Set, Banana, 14/set, AHA
900179-202
CAM 14 ECG Connector Set, Mactrode, 14/set, AHA
900179-203
CAM 14 ECG Connector Set, Grabber, 14/set, AHA
9490-210
Electrode Adapter Set, 10/set
9490-214
Electrode Adapter Set, 14/set
Acquisition Module Cables The following acquisition module cables have been approved for use with this device. Acquisition Module Cables Part Number
Description
2016560-001
CAM 14 Coiled Patient Cable, 50 in (1.3 m)
2016560-003
CAM 14 Coiled Patient Cable, round connector, 15 ft (4.6 m)
KISS Aspiration System Accessories The following KISS Aspiration System accessories have been approved for use with this device. KISS Aspiration System Accessories
14
Part Number
Description
21732801
Suction Electrode, KISS ES600
30344377
Swivel Attachment Arm for Kiss
30344419
Extension tube for KISS ES600 Pump, 5 ft (1.5 m)
30344427
Blind Plug for KISS
30344434
Leadwire, KISS, AHA, 50 in (127 cm), V1
30344435
Leadwire, KISS, AHA, 50 in (127 cm), V2
30344436
Leadwire, KISS, AHA, 50 in (127 cm), V3
30344437
Leadwire, KISS, AHA, 50 in (127 cm), V4
30344438
Leadwire, KISS, AHA, 50 in (127 cm), V5 MAC® 5500/MAC® 5500 HD
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Introduction
KISS Aspiration System Accessories (cont'd.)
2046275-016A
Part Number
Description
30344439
Leadwire, KISS, AHA, 50 in (127 cm), V6
30344440
Leadwire, KISS, AHA, 57 in (147 cm), LL
30344441
Leadwire, KISS, AHA, 57 in (147 cm), LA
30344442
Leadwire, KISS, AHA, 57 in (147 cm), RA
30344443
Leadwire, KISS, AHA, 57 in (147 cm), RL
38401590
KISS Leadwire Set, IEC, 10/set, mixed lengths
93204775
KISS Electrode Filter Disc, 100/bag
2022862-001
ECG Leadwire, KISS Multilead, 50 in (127 cm), I
2022862-003
ECG Leadwire, KISS Multilead, 50 in (127 cm), E
2022862-004
ECG Leadwire, KISS Multilead, 50 in (127 cm), M
2022862-005
ECG Leadwire, KISS Multilead, 50 in (127 cm), H
2022862-006
ECG Leadwire, KISS Multilead, 50 in (127 cm), A1
2022862-007
ECG Leadwire, KISS Multilead, 50 in (127 cm), A2
2022862-008
ECG Leadwire, KISS Multilead, 50 in (127 cm), A3
2022862-009
ECG Leadwire, KISS Multilead, 50 in (127 cm), A4
2024037-001
KISS ES600 Electrodes & Leadwires, Standard, 10/set, mixed lengths
2024038-001
KISS Upgrade Electrodes & Leadwires, FRANK, 4/set, 50 in (127 cm), H, E, I, M
2024039-001
KISS Upgrade Electrodes & Leadwires, NEHB, 2/set, 50 in (127 cm), Nst, Nax
2024040-001
KISS Upgrade Electrodes & Leadwires, 4/set, 50 in (127 cm), A1 - A4
30344365
Leadwire, KISS, IEC, 50 in (127 cm), C1
30344366
Leadwire, KISS, IEC, 50 in (127 cm), C2
30344367
Leadwire, KISS, IEC, 50 in (127 cm), C3
30344368
Leadwire, KISS, IEC, 50 in (127 cm), C4
30344369
Leadwire, KISS, IEC, 50 in (127 cm), C5
30344370
Leadwire, KISS, IEC, 50 in (127 cm), C6
30344371
Leadwire, KISS, IEC, 57 in (147 cm), F
30344372
Leadwire, KISS, IEC, 57 in (147 cm), L
30344373
Leadwire, KISS, IEC, 57 in (147 cm), R
30344374
Leadwire, KISS, IEC, 57 in (147 cm), N
30344375
Leadwire, KISS, IEC, 50 in (127 cm), NST
30344376
Leadwire, KISS, IEC, 50 in (127 cm), NAX
43252125
Suction Dome, KISS
MAC® 5500/MAC® 5500 HD
15
Introduction
Papers The following thermal papers have been approved for use with this device. Papers Part Number
Description
9402-020
Premium Thermal-Sensitive Chart Paper, Full Page Red Grid, 8.5 in x 11 in. (216mm x 280mm) Sheet, Z-fold, Queue Hole, 300 sheets/pack, 8 packs/case, 2400 sheets/case
9402-021
Premium Thermal-Sensitive Chart Paper, Full Page Red Grid, A-4 Modified, 8.26 in x 11 in (210mm x 280mm) Sheet, Z-fold, Queue Hole, 300 sheets/pack, 8 packs/case, 2400 sheets/case
9402-024
Premium Thermal-Sensitive Chart Paper, Red Grid Blank Interpretation Area, 8.5 in x 11 in. (216mm x 280mm) Sheet, Z-fold, Queue Hole, 300 sheets/pack, 8 packs/case, 2400 sheets/case
9402-034
Archivist 100 Thermal-Sensitive Chart Paper, Full Page Red Grid, 8.5 in x 11 in. (216mm x 280mm) Sheet, Z-fold, Queue Hole, 300 sheets/pack, 8 packs/case, 2400 sheets/case
9402-035
Archivist 100 Thermal-Sensitive Chart Paper, Full Page Red Grid, A-4 Modified, 8.26 in x 11 in (210mm x 280mm) Sheet, Z-fold, Queue Hole, 300 sheets/pack, 8 packs/case, 2400 sheets/case
9402-061
Premium Thermal-Sensitive Chart Paper, Red Grid Blank Interpretation Area, 8.5 in x 11 in. (216mm x 280mm) Sheet, Z-fold, Queue Hole, 150 sheets/pack, 16 packs/case, 2400 sheets/case
Miscellaneous Accessories The following miscellaneous accessories have been approved for use with this device. Miscellaneous Accessories
16
Part Number
Description
21708318
Electrode Cream, 250ml bottle
21730701
Electrode Contact Spray, 200ml bottle
2034731-002
Electrode Gel, 250ml bottle, 4/case
2034741-002
Epicont Cream, 250ml bottle, 4/case
2046978-001
Electrode Cream, 250ml bottle, 4/case
21730702
Electrode Contact Spray, 200ml bottle, 10/box
21730705
Electrode Contact Spray, 2 L
401210-001
Signacreme® Electrode Cream, 5oz bottle, 12/case
401210-003
Signacreme® Electrode Cream, 70 oz bottle w/pump
9812-014
Signagel® Electrode Gel, 250g tube, 12/box
MAC® 5500/MAC® 5500 HD
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Introduction
Equipment Symbols The following symbols may appear on the product or its packaging. Symbol
Description Type BF equipment. The acquisition module is protected from defibrillation shocks. Alternating Current Equipotential
Charge the battery. The flashing amber LED next to this symbol indicates you must connect the system to AC power to recharge the battery. Waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact an authorized representative of the manufacturer for information concerning the decommissioning of your equipment.
Recycle the battery. Consult the accompanying documentation.
Classified with respect to electric shock, fire, mechanical, and other specified hazards only in accordance with applicable UL standards.
To reduce the risk of electric shock, do NOT remove cover (or back). Refer servicing to qualified personnel. This product consists of devices that may contain mercury, which must be recycled or disposed of in accordance with local, state, or country laws. (Within this system, the backlight lamps in the monitor display contain mercury.) Manufacturer name and address.
Authorized European representative. PCT. GOST marking symbolizing conformity with applicable Russian Gosstandart technical and safety standards.
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Introduction
Symbol
Description USA Only: For use only on or by order of a physician.
CE Mark - Symbolizes conformity with applicable EU (European Union) directives.
18
MAC® 5500/MAC® 5500 HD
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Introduction
Product and Packaging Labeling This section identifies the product labels and their locations on the product and packaging.
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Introduction
Refer to the previous illustrations for the locations of the labels identified in the following table.
20
No. Label
Description
1
Located on the bottom of the device, this label indicates the device contains mercury and must be disposed of in accordance with state and local laws.
2
Located on the cover of the device, this label identifies the product's model number.
3
Located on the back of the device, this label contains the Disposal and GOST labels. Refer to “Equipment Symbols” on page 17 for detailed descriptions of the symbols.
4
Located inside the writer compartment, this label uniquely identifies this unit. Refer to “Product Label” on page 22 for detailed information.
5
Located on the back of the device, this label provides regulatory and cautionary information. Refer to “Equipment Symbols” on page 17 for detailed descriptions of the symbols.
6
Located on the back of the device, this label identifies the device's electrical ratings.
7
Located inside the battery compartment, this label provides information about the specifications and disposal of the battery. Refer to “Equipment Symbols” on page 17 for detailed descriptions of the symbols.
8
Located on the front of the device, this label indicates that, in the USA, federal law restricts sale of the device to or on the order of a physician.
9
Located below the display, this label indicates the device uses the Marquette™ 12SL™ ECG Analysis Program to analyze and interpret ECG readings.
MAC® 5500/MAC® 5500 HD
2046275-016A