MAC 5500 and MAC 5500 HD Operators Manual Rev A

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.

2

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

3

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

14

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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MAC® 5500/MAC® 5500 HD

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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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9

Introduction

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

MAC® 5500/MAC® 5500 HD

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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.)

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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

2046275-016A

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.

2046275-016A

MAC® 5500/MAC® 5500 HD

19

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