NorthEastMonitoring_Products by harsathe

NorthEast Monitoring, Inc. advancing Holter technology™

Product Line DR180+ Digital Holter Recorders 3-Channel 5- or 7-lead OxyHolter ® 12-lead  DR200 Digital Recorders:  DR200/HE 3-, 5- or 7-lead Holter and 2- or 3-lead Event  DR200/E “Tel-a-heart™” 2- or 3-lead Event  Holter LX® Analysis Software  LX® Sleep Software for AHI / OSA  LX® Event Software  LX® Pro Database Software  Industry-leading 3-year warranty

NorthEast Monitoring is a medical electronics company that develops high quality, rugged products to address diagnostic, clinical and research needs in cardiology, respiratory, and pulmonary applications. Our products accurately capture, efficiently store and quickly analyze critical high quality, real-time data. Our software tools use powerful digital signal processing algorithms and an intuitive user interface to enable rapid manipulation, display, storage and reporting of data. The product line is the result of steady refinement and application of new technology in the field of ambulatory measurement. Since 1970, the founders of the company (and creators of the original “Holter for Windows™”) have constantly brought innovative thinking, creative vision and the latest technology to the ambulatory measurement products on which the company is based. This steady, evolutionary approach has served our customers well by providing them with products that add functionality generation after generation, operate well within their specifications and simply last longer. All units are rugged and built to last, and the software puts the user first. They carry the industry’s best warranty of 3 years, along with optional extensions for 5 or more years. Choose the best unit for your application -- the “tried and true” DR180+ with many lead options and optional oximetry, or the new, smaller, lighter DR200 with Holter and/or Event options. A number of key features make these recorders the quality and technology leaders in the industry today. Contact NorthEast or read on for more details. At NorthEast Monitoring, we are always “advancing Holter technology.”

For complete product descriptions, please see the appropriate Product Data Sheet.

Brief Product Description DR180+ Digital Holter Recorder, 3CH (5- or 7-lead)

The DR180+ 3CH (3 channel) comes in 5- or 7-lead configuration. It is designed with the following three goals in mind: ease-of-use for the patient and clinician, accuracy of the data and durability of the unit.

DR180+ Digital Holter Recorder, 12-lead

The DR180+ in a 12-lead configuration provides a high-quality research and clinical evaluation tool. It records 12-lead / 9 channels of data -- no short-cuts! This 12-lead system does not use arithmetically derived or reconstructed data from non-standard Holter lead hook-ups.

DR180+ Series

DR180+ OxyHolter®, Holter and Oximetry Recorder

The OxyHolter® is unique in the industry. It represents a quantum step in your ability to quickly isolate (or correlate) cardiac and pulmonary issues. With synchronized sets of data -- one set of cardiac data (standard Holter) and one set of pulmonary data (saturated O2 levels via pulse oximetry) conveniently obtained via the DR180+ and NorthEast’s proprietary OxyHolter® cable -the system helps to determine the need for further tests and/or root causes of many pathologies.

DR200/E and DR200/E-a “Tel-a-heart™” Event Recorder, 2- or 3-lead

The DR200/E “Tel-a-heart™” is the first member of the DR200 series of Event Recorders. It is available with several options to fit a broad range of requirements for ambulatory event recorders.

DR200/HE Holter and Event Recorder, 3-, 5- or 7-lead Holter and 2- or 3-lead Event The DR200/HE is the industry’s smallest, single unit Holter plus Event recorder. It may be deployed with a patient in either mode. It combines all of the features of the DR200/HE Holter monitor and the DR200/E “Tel-a-heart™” Event recorder in one, small, rugged unit. It gives the doctor’s office and the large service provider a simplified approach to maintaining sufficient inventory of two different products when the optimum number of each may vary.

Holter LX® Analysis Software

The Holter LX® Analysis Software comes in five levels of functionality: Remote, Basic, Enhanced, Enhanced Plus, and Pro. Each is tailored to address the varied needs of our diverse user community.

DR200 Series

LX® Sleep Software for AHI / OSA*

Utilizing a proprietary algorithm for combining ECG, SpO2 and respiratory information collected via OxyHolter, LX Sleep provides the most inexpensive, convenient, at-home, multi-parameter, unattended sleep analysis to diagnose OSA and provide an accurate AHI. Suitable for CPAP prescription.

LX® Event Software

The LX® Event Software raises the standards of convenience and flexibility for handling ECG data from looping event recorders. LX Event is compatible with event recorders from other manufacturers but offers special advantages when used with NorthEast’s DR200/HE Combination Holter + Event recorder or DR200/E “Tel-a-heart” event recorder.

Holter LX® Pro Database Software

LX® Based on the popular FileMaker® Pro & and Holter LX® Pro, this database stores up to 1.5 million complete patient reports in a searchable format. It is aimed at larger facilities that must efficiently manage and “mine” thousands of patient data sets to see trends, support research, generate complex comparative studies and in general manage large amounts of cardiac patient data.

*Pending FDA Market Approval in the U.S.A. NB: In the U.S.A., Federal Law restricts devices to sale by or on the order of a physician. For in vitro diagnostic use. Not intended to replace realtime telemetry monitoring for patients suspected of having life-threatening arrhythmias. June, 2008

Software Series

Windows is a registered trademark of the Microsoft Corporation in the USA and other countries. FileMaker is a registered trademark of FileMaker, Inc.

NorthEast Monitoring, Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754 U.S.A. www.nemon.com

phone: 978-461-3992 fax: 978-461-5991 toll free: 866-346-5837

0413

NorthEast Monitoring, Inc. advancing Holter technology™

DR200/HE Holter and Event Recorder The DR200/HE is the industry’s first combination

Meets EC-38 standard

14-day Holter plus Event recorder. It can be deployed to a patient in either Holter or Event mode. In Holter



14-day Holter capability

mode with a single, fully charged AA battery and a 1GigaByte data card, the unit can operate as a 14-



Multiple Language capability

day Holter. When the DR200/HE is combined with

Ergonomic Design

efficient manner and you’ve increased the probability of

Holter LX Analysis and LX Event software, you have the flexibility to use your capital equipment in the most



Proven reliability 

capturing elusive cardiac events. It is the best solution for your practice and the best solution for your patient, which is another good combination! The DR200/HE blends the features of the DR200/E “Tel-a-heart” Event recorder (see the

Maximize Holter and Event reimbursements

DR200/E Data Sheet for complete details) and the established technology of the tried-and-true

Reduce artifact with low-cost, shielded cables

to establish a new price-performance benchmark in ambulatory cardiac monitors. The unit is

Pacemaker detection standard

When deployed as a Holter, the DR200/HE has either 3-, 5- or 7-lead cables. When



Combination Holter and Event 

Industry-leading 3-year warranty

“workhorse” DR180+ Holter in a single, compact, rugged unit. New advanced DSP hardware and specially designed signal processing algorithms squeeze every milli-watt out of the battery

approximately one-half the size and weight of the DR180+, has smaller cable profiles for patient comfort, yet adds more functionality and convenience.

deployed as a Tel-a-heart Event monitor, it uses a 2- or 3-lead cable. The DR200/HE kit includes Holter cable, pouch, belt clip, removable media memory card, Operator’s Manual and Hook-up Guide. At NorthEast, we are advancing Holter technology - smaller in size, lower in cost, compatible with all levels of LX Analysis, the industry’s best warranty of 3 years, with an optional extension to 5 or more years – the DR200/HE is the technology and quality leader in the industry today. For more information on the DR200/HE combination Holter and Event Recorder, please contact NorthEast or read on for more details.

™

DR200/HE Features Meets EC-38 standard

Meets applicable sections of ANSI/AAMI ED38-1994 “Ambulatory Electrocardiographs.”

14 day Holter capability captures infrequent cardiac events

Efficient low-power design and robust LX Analysis software now makes it possible to use the DR200/HE in Holter-mode over a 14-day period to capture infrequent cardiac events without the need to rely on patient interaction or automatic detection.

Multiple Language Capability

Select from English, Danish, Finnish, French, German, Italian, Polish, Portuguese and Spanish.

Ergonomic design

Large, easy view LCD (liquid crystal display) screen, soft-keys and a very simple user interface make the unit exceptionally easy to use.

DR200/HE Specifications Recording duration:

14 days with alkaline battery

Proven reliability

Recording bandwidth:

Maximize Holter and Event reimbursements

Resolution:

Built on the platform of the reliable DR180+, there are thousands of Holter units deployed worldwide. Real-world experience is designed into every unit.

Our system allows your office to “capture” reimbursement for all components of CPT (Current Procedural Terminology) allowed for Holter and Event. Removable digital storage memory (compact flash) allows for rapid re-deployment of the unit to the next patient.

Reduce artifact with low cost, shielded cables

Shielded cables provide better signal integrity and noise immunity. Our cables are carefully shielded and impedance matched and provide better SNR than any other cable on the market. Low cost cables drive down the total cost of ownership.

0.05 - 70 Hz

12-bit, 12.50 µV/LSB

Sampling rate:

180 samples/second

Dimensions:

8.6 cm x 6.0 cm x 2.0 cm (3.9 in x 2.4 in x 0.8 in)

Pacemaker detection standard

Weight:

Industry-leading 3-year warranty

Power:

The conflicting requirements for signal sensitivity (wide bandwidth and high sample rate) and long battery life have been uniquely resolved to provide the most accurate diagnostic information.

These units are built-to-last. Our field return rate is proven to be so low that we can offer the industry’s longest warranty -- and then extend that to 5 or more years to add even more value to your investment.

99.3 grams (3.5 oz), with battery 70.9 (2.5 oz), without battery

1 AA battery: alkaline, NiMH rechargeable, or lithium

Storage capacity:

Maximize good quality recording cycles

32 MB - 1 GB SD Flashcard

Checks battery state and lead hook-up quality, date and Patient ID on LCD prior to deployment. No mix-ups with patient data because patient ID is encoded on memory card.

All digital recording

Reliable digital technology is used throughout, enhancing service life and lowering total cost of ownership.

Distributed by:

Compatible with Holter LX® Analysis and LX Event software (See DR200/E Data Sheet for additional, event-specific features.)

FDA K061293, K070014 NB: In the U.S.A., Federal Law restricts devices to sale by or on the order of a physician. For in vitro diagnostic use. Not intended to replace real-time telemetry monitoring for patients suspected of having life-threatening arrhythmias. April, 2008

NorthEast Monitoring, Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754 U.S.A. www.nemon.com

phone: 978-461-3992 fax: 978-461-5991 toll free: 866-346-5837

0413

NorthEast Monitoring, Inc. advancing Holter technology™

DR181 Digital Holter Recorder, 3CH Meets EC-38 standard  Ergonomic design  Proven reliability  Maximize Holter reimbursements  Reduce artifact with shielded cables  Pacemaker detection standard  Foreign language interfaces  Industry-leading 3-year warranty

The DR181 is the latest version of the reliable and popular DR180 series. The DR181 3CH (3 channel) comes in a 5- or 7-lead configuration. It is designed with the following three goals in mind: ease-of-use for the patient and clinician, accuracy of data, and durability of the unit. Large, programmable soft-keys, easy-to-read, multi-line LCD and several foreign language options are among the features that distinguish this “tried and true” unit. Its extra battery capacity makes it perfect for long Holter studies of up to 72 hours. It performs as well in a small practice as in a large clinic or full service (scanning) provider. Built-in safeguards insure deployment with sufficient battery levels, high-quality lead hook-ups and complete patient ID. The DR181 prevents identification mix-ups by storing Patient ID on removable media. DR181 units may be rapidly re-deployed to the next patient while patient data is analyzed from the removable media. All units are rugged and built to last. They carry the industry’s best warranty of 3 years, along with optional extensions to 5 or more years. Choose the best unit for your application. A number of key features make these units the quality and technology leader in the industry today. Contact NorthEast or read on for more details.

DR 181 Features Meets EC-38 standard Meets applicable sections of ANSI/AAMI ED38-1994 “Ambulatory Electrocardiographs.”

Ergonomic design Large, easy view screen and soft-keys make the unit exceptionally easy to use. The large Event marker button operates in conjunction with interactive and customizable patient diary via user-programmable soft-keys.

Proven reliability Thousands of Holter units are in use worldwide. Real-world experience is designed into every unit.

Maximize Holter reimbursements Our system allows your office to “capture” reimbursement for all applicable CPT (Current Procedural Terminology) codes for Holter. Removable digital storage memory (compact flash) allows rapid re-deployment of the unit to the next patient

DR181 Digital Recorder Specifications Recording duration:

72 hours, with lithium batteries 48 hours, with alkaline batteries 24 hours, with rechargeable batteries

Recording bandwidth:

Reduce artifact with shielded cables Shielded cables provide better signal integrity and noise immunity. Our cables are carefully shielded and impedance matched and provide better SNR than any other cable on the market. Active electronics built into the cable accurately capture oximetry data..

Pacemaker detection standard The conflicting requirements for signal sensitivity (wide bandwidth and high sample rate) and long battery life have been uniquely resolved to provide highly accurate diagnostic information.

Foreign language interfaces Multiple foreign languages are programmed into each unit to suit diverse patient populations. Currently support Danish, English, Finnish, French, German, Italian, Polish, Portuguese, Spanish and Turkish.

Industry-leading 3-year warranty These units are built-to-last. Our field return rate is proven to be so low that we can offer the industry’s longest warranty -- and then extend that to 5 or more years to add even more value to your investment.

Cable options May be used with 5-lead, 7-lead or Oxymetry (oxy plus 5-lead) cables.

Maximize good quality recording cycles Checks battery state, lead hook-up quality, date and patient ID on LCD prior to deployment. No mix-ups with patient data because patient ID is encoded on memory card.

0.05 - 70 Hz

Resolution:

12-bit, 12.50 µV/LSB

Prefilter sampling rate: 1440 samples/second

Dimensions:

12.3 cm x 7.0 cm x 2.4 cm (4-7/8 in x 2-3/4 in x 1.0 in)

Weight:

1 84 grams (6.5 oz.),with batteries and SD card; 136 grams (4.8 oz.), without batteries

Power:

2 AA batteries: alkaline, rechargeable or lithium

Storage capacity:

32 MB - 2 GB SD flashcard

Distributed by:

All digital recording Reliable digital technology is used throughout, enhancing service life and lowering total cost of ownership.

Compatible with NorthEast LX® Analysis software

FDA K001288 NB: In the U.S.A., Federal Law restricts devices to sale by or on the order of a physician. For in vitro diagnostic use. Not intended to replace real-time telemetry monitoring for patients suspected of having life-threatening arrhythmias. June 2011

NorthEast Monitoring, Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754 U.S.A. www.nemon.com

phone: 978-461-3992 fax: 978-461-5991 toll free: 866-346-5837

0413

NorthEast Monitoring, Inc. advancing Holter technology™

Holter LX ® Analysis Software Five user levels

 Compatible with all NorthEast monitors

 Up to 14-day Holter Studies

 User-customized reports

 LAN/WAN support

NE Ca VER ptu M Le re a ISSAt L ll do X A the BEA the nal bea T wo ysis ts. rk!

R LTE O Y H tery + d = A D t r 14- e ba ry ca On emo ks! e e m o we n O Tw

 Fast, accurate analysis and proprietary features reduce editing time



The Holter LX® Analysis Software comes in five levels of functionality: Remote, Basic, Enhanced, Enhanced Plus, and Pro. Each is tailored to address the varied needs of our diverse user community. The software and efficient file structure on which it is built offer the doctor’s office, the scanning service, or the most demanding cardiac research or clinical applications, the fastest and most userfriendly environment in which to reduce megabits of data to the critical reports necessary in today’s world. The software supports networking and remote satellite office transmission. A number of proprietary features make this software unique; the most productive and highly

Natural, intuitive editing speeds report generation

regarded in clinical and diagnostic communities. Contact NorthEast for an informative tour of LX®





Industry-leading 3-year warranty

Analysis Software via the Internet. Sit back, relax, and let our professionals show you beat-by-beat how to use the software. (Broadband or DSL high-speed connection required.)

“...the Gold Standard for our laboratory, ... used in over 200 clinical sites world-wide for continuous monitoring research in acute MI patients.”

Mitchell W. Krucoff, M.D., F.A.C.C. Associate Professor Medicine/Cardiology, Duke University Medical Center Director, Static & Continuous ECG Core Laboratory, Duke Clinical Research Institute

Holter LX ® Analysis Software Five user levels: Basic, Enhanced, Enhanced Plus, Pro and Remote Up to 14-Day Holter studies

Never miss a beat. Let the software sort and categorize thousands of beats. Consolidate or split the data from multi-day studies along your preferred boundaries. Trends, averages, totals, tables, etc. automatically adjusted.

Compatible with all NorthEast digital recorders

Benefits Multi-day studies Multi-day billings Capture every AF

All NorthEast hardware uses the same software and db structure.

User-customized reports

Customized reports match your needs, e.g., contact information, diagnostic terms, morphological terms, key phrases and more.

Never miss-a-beat

LAN/WAN support

Runs on newest hardware & software

Fast, accurate analysis & proprietary features reduce editing time

Evaluate LX Pro for free

Supports local office networks (LANs) and remote, satellite offices (WAN transmit/receive).

EQD - Enhanced QRS Detection plus proprietary algorithms means a higher percentage of automatically and correctly characterized beats. ATC - Adaptive Template Construction fits a series of templates to a wide range of cardiac morphologies, reducing the need for manual intervention. Compact db structure - An optimized and efficient database structure that does not compromise accuracy simply means faster download times to LX® Analysis software. CMA - Coefficient Matching Algorithms run faster than other products and take less time to reanalyze the data. ASTAT - Automatic ST segment Analysis Tool sets markers, measures the ST segment on all channels, plots the average and baseline values, highlights events with computer-assisted event selection. Spectral analysis -- Reveals critical diagnostic information not easily recognized in the time domain. 12-lead display -- When 12-lead data are available, they can be fully displayed. This includes 3D plots and detailed ST/QT measurements with software calipers. Full disclosure -- Provides this display for a variety of reports and reimbursements as well as clinical studies. Synchronized SpO2 -- With the Oximetry option, see the relationship between blood O2 levels and Holter cardiac data. Quickly separate cardiac and pulmonary issues or recommend further lab work, e.g., full sleep study. SCCB - Software Controlled Channel Blocking can block any channel(s) in the display to eliminate artifact that obscures good data.

Natural, intuitive editing modes speed report generation

Natural drag ‘n drop motif provides an easy, intuitive graphical user interface. LX® Analysis Software switches rapidly to the right context -- from beat, strip, page, trend or full disclosure; all are just one click away.

Better patient compliance

Key Features 14-Day Holter Studies Fully Supported 5 Levels to choose from, including new Remote that allows you to send patient Holter data Windows XP™ and Windows Vista™ compatible* Date/version controlled licensing *Windows XP and Windows Vista are registered trademarks of Microsoft Corporation

Availability FREE under warranty FREE under eMSA

Industry-leading 3-year warranty

Includes Hotline support and software updates during Warranty period. eMSA (extended Maintenance and Service Agreement) available.

One time updates

Distributed by:

FDA K930564 NB: In the U.S.A., Federal Law restricts devices to sale by or on the order of a physician. For in vitro diagnostic use. Not intended to replace realtime telemetry monitoring for patients suspected of having life-threatening arrhythmias. December, 2007

NorthEast Monitoring, Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754 U.S.A. www.nemon.com

phone: 978-461-3992 fax: 978-461-5991 toll free: 866-346-5837

0413

NorthEast Monitoring, Inc. advancing Holter technology™

Holter LX ® Analysis Software - Features Matrix Software Feature / Arrhythmia

Software Level PRO 9*** 9 9 9 9 9 9 9 9 9 9**

ENHANCED+ 9*** 9 9 9 9 9 9 9 9 9 9**

ENHANCED 9*** 9 9 9 9 9 9 9 9 9 9**

Calibration Strips Configuration Critical Events Failure To Capture Failure To Sense Inhibition Insert Beat Interval Editor Pause Saved Strips ST Baseline ST Depression ST Deviation (Maximum) ST Elevation SVPB, SVPB Pair, SVT Time Domain Hrv True 12-Lead VPB, VPB Pair, VTAC

9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9* 9

AFib On/Off Remote Receive, Remote Receive, Other Review Bins Templates Beats

9 9*** 9 9 9 9

Bigeminy Bradycardia Early VPB Fastest SVT Fastest VTAC Irregular R-R Longest R-R Longest SVT Longest VTAC Quadrageminy R On T VPB Spectral Analysis Spectral Plots & Tables ST End ST Maximum HR ST Onset Tachycardia Trigeminy

9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9 9

Remote Send, Remote Send, Other 1 Strip Per Hour Bi-Directional Scanning Diary Entry Event Marker Label Strips Maximum Heart Rate Minimum Heart Rate Page Mode SpO2

* DR180+ Recorder required

**DR180+ and purchase of Sp02 cable required

BASIC 9*** 9 9 9 9 9 9limited 9 9 9 9**

REMOTE 9*** 9

*** MagicVORTEX Account required

Holter LX ® Analysis Software REPORT Features Matrix Report Feature

Software Level PRO 9 9 9 9 9 9 9 9 9 9 9*

ENHANCED+ 9 9 9 9 9 9 9 9 9 9 9*

ENHANCED 9 9 9 9 9 9 9 9 9 9 9*

12- lead strips - 25 mm/sec 12-lead strips - 50 mm/sec General profile/trends HRV time summary ST episodes Time domain

9* 9* 9 9 9 9

Normal bins Paced bins Paced data information / heart rate trend Ventricular bins

9 9 9 9

12-lead trends 3-D plot “waterfall graph” (spectral) Bradycardia/Tachycardia Table Circadian plots (spectral) Critical events Frequency domain table (spectral) Hourly rhythm page List of saved events Normalized frequent domain (spectral) Paced interval histograms Paced summary Print expanded HR/ST trends Scanning criteria/settings Spectral HRV (frequency domain) ST analysis triaxial graph Supraventricular summary Ventricular summary *12-lead recorder option required

9* 9 9 9 9 9 9 9 9 9 9 9 9 9 9* 9 9

Back-up and restore (CD-RW required) Comments page Full disclosure print - 1 hour to 48 hours Full disclosure print - single channel Full disclosure print - two channel List of diary events Patient information summary: 4 choices Print full-sized strips Print review screen Status window 12-lead table (25 pages)

BASIC 9 9 9 9 9 9 1 only 9 9 9 9*

Industry-leading 3-year warranty NB: In the U.S.A., Federal Law restricts devices to sale by or on the order of a physician. For in vitro diagnostic use. Not intended to replace realtime telemetry monitoring for patients suspected of having life-threatening arrhythmias. December, 2007

NorthEast Monitoring, Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754 U.S.A. www.nemon.com

phone: 978-461-3992 fax: 978-461-5991 toll free: 866-346-5837

0413

NORTHEAST MONITORING, INC TWO CLOCK TOWER PLACE, SUITE 555 MAYNARD, MA 01754 Ph: (978) 461-3992 Fax: (978) 461-5991

Holter Monitor Report Patient Name: Betty Boop

Physician:

Dr. Waxman

Date Of Birth: ID #: Age: Sex: Analyst: Interp.Physician: Indications:

Scan Number: Date Recorded: Date Processed: Recorder Num: Hook-up Tech:

15 12/29/2006 2/4/2007 0000197394 sr

Medications:

None noted

11/21/1963 10999222 43 Years F sr Dr. Caveman Dizziness Palpitations Shortness of breath

Recording information 4:44PM1 Start time 24:01 Duration 23:58 Time analyzed General summary Ventricular 111954 QRS complexes 10475 Singles 10525 Ventricular beats ( 9.4%) 25 Pairs 0 Supraventricular beats ( 0.0%) 0 Runs 0.1 % total time classified as artifact 0 Total beats in runs 0 Beats in longest run at 4:44PM1 (HR= 78 Average heart rate 0 Beats in fastest run at 4:44PM1 (HR= 52 Minimum heart rate at 3:10AM2 0 R on T 140 Maximum heart rate at 12:47AM2 1.39 Longest RR (seconds) at 5:18AM2 Supraventricular (at least 20% premature) 0 Pauses (greater than 2.5 sec.) 0 Singles 0 Aberrant ST events 0 Pairs Maximum elevation 0 Runs *** mm. Channel * at 12:00AM1 0 Total beats in runs Maximum depression 0 Beats in longest run at 4:44PM1 (HR= *** mm. Channel * at 12:00AM1 0 Beats in fastest run at 4:44PM1 (HR= Comments:

0) 0)

NUMERIC FRONT PAGE

Physician's Signature:

Copyright NorthEast Monitoring Inc. 1993-2004 All data printed in the reports should be reviewed by a qualified physician.

NorthEast Monitoring, Inc. advancing Holter technology™

“Tel-a-heart”™ Event Recorders DR200/E and DR200/E-a

Meets EC-38 standard  Multiple Language capability  Ergonomic design  Proven reliability  Maximize event reimbursements  Reduce artifact with shielded cables  Pacemaker detection standard  Auto-detect and Smart Mode event selection  Industry-leading 3-year warranty

The DR200/E “Tel-a-heart” is the first member of the DR200 series of Event Recorders. It is available with several options to fit a broad range of requirements for ambulatory event recorders. The standard patient hook-up cable is a 2-lead cable that supports 1 channel of data. An optional 3-lead cable provides 2 channels of data. The DR200/E has the typical acoustic data transmission capability, but adds value with digital data transmission via a removable, secure media flash card.

The DR200/E-a has the additional auto-detect capability to automatically detect an event and begin recording it with the programmable length periods of pre- and post-event data. This requires no action by the patient. The DR200/E-a pushes the state-of-the-art even further with Smart Mode event selection to select the best sample of each type of arrhythmia from within an Event window.

The DR200/E “Tel-a-heart” Event Recorder in acoustic mode is compatible with any event software, including LX Event from NorthEast. The digital data stored on the secure media flash card requires LX Event software from NorthEast.

All units are rugged and built to last. They carry the industry’s best warranty of 3 years, along with optional extensions to 5 or more years. Choose the best unit for your application.

A number of key features make these units the quality and technology leader in the industry today. Contact NorthEast or read on for more details.

™

DR200/E “Tel-a-heart” Features Meets EC-38 standard

Meets applicable sections of ANSI/AAMI ED38-1994 “Ambulatory Electrocardiographs.”

Multiple Language Capability

Select from English, Danish, Finnish, French, German, Italian, Polish, Portuguese and Spanish.

Ergonomic design

Large, easy view LCD (liquid crystal display) screen, soft-keys and a very simple user interface make the unit exceptionally easy to use. Pre Event Sec - adjusts loop time stored prior to an event Post Event Sec - adjusts loop time stored after an event Max Events - sets maximum number of events to be recorded and automatically adjusts recording interval per event Channels - sets mode for 1- or 2-channel recording Non-volatile memory - stores events even if battery power is lost Oops-proof data saver - precludes premature erasure of potentially important recorded event data Multi-mode Event transfers - Transfer stored events in any of the following modes - telephonic (POTS), microphone, data card. Restrictions may apply for reimbursement.

DR200/E “Tel-a-heart”™ Specifications Recording duration: 30 days with alkaline battery

Proven reliability

Recording bandwidth:

The entire DR200 series utilizes field experience gained from the popular DR180+, with thousands of units deployed world-wide. Real-world experience is designed into every unit.

0.05 - 70 Hz

Resolution:

Maximize Event reimbursements

Our system allows your office to “capture” reimbursement for all applicable CPT (Current Procedural Terminology) codes for pre- and post-symptom cardiac event monitor.

12-bit, 12.50 µV/LSB

Reduce artifact with shielded cables

Sampling rate:

Shielded cables provide better signal integrity and noise immunity. A patent-pending technique eliminates the 3rd lead and can provides high-quality, 1-channel data. Our cables are fully shielded and impedance matched to provide 6-10 dB better SNR than any other cable on the market. With fewer electrodes, they are easier to apply than any other event cable.

180 samples/second

Dimensions:

8.6 cm x 6.0 cm x 2.0 cm (3.9 in x 2.4 in x 0.8 in)

Pacemaker detection standard

The conflicting requirements for signal sensitivity (wide bandwidth and high sample rate) and long battery life have been uniquely resolved to provide highly accurate diagnostic information.

Weight:

99.3 grams (3.5 oz), with battery 70.9 (2.5 oz), without battery

Auto-detect and SMES (Smart Mode Event Selection)

Events are automatically detected and recording of the event is begun automatically. Pre- and post-event data is stored according to the setup values. Auto-detect removes the need for a patient to identify events. The Smart Mode Event Selection automatically selects the best sample of each type of arrhythmia (bradycardia, tachycardia, pause, atrial fibrillation) from within the programmable event window.

Power:

1 AA battery: alkaline, NiMH rechargeable, or lithium

Industry-leading 3-year warranty

Storage capacity:

90 minutes

Maximize good quality recording cycles

Checks battery state and lead hook-up quality prior to deployment. Transmissions include date and recorder ID.

All digital recording

Distributed by:

Reliable digital technology is used throughout, enhancing service life and lowering total cost of ownership.

NorthEast Monitoring, Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754 U.S.A. www.nemon.com

phone: 978-461-3992 fax: 978-461-5991 toll free: 866-346-5837

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NorthEast Monitoring, Inc. advancing Holter technology™

LX ® Event Software Compatible with all telephonic Event Recorders

 Many additional features for DR200 users



Complete kit supports three transmission modes

 Filter and adjust ECG data to improve analysis and output

 Multiple measurements and cursors available

LX® Event software offers the most comprehensive and flexible way to handle ECG data from looping event recorders. Error code detection and correction make this the most reliable and accurate ECG capture software on the market today. LX® Event is compatible with event recorders from other manufacturers, but offers special advantages when used with NorthEast Monitoring’s DR200/HE Combination Holter + Event recorder or DR200/E “Tel-a-heart” Event Recorder.

 Customizable reports

 Searchable patient data base

 Industry-leading 3-year warranty

LX® Event software supports three reception modes: telephone transmission via conventional telephone line (FM modulation), local recording via a microphone, and for DR200 users, SD card recording via a convenient digital data card. Multiple patient file transmissions can be automatically associated within a single procedure for each patient. The patient database is easily searchable by a number of patient criteria. Automatic event detection with the DR200, filters and other adjustments allow for more accurate interpretation and processing of the ECG data. Contact NorthEast for an informative tour of LX® Event Software via the Internet. Sit back, relax, and let our professionals show you beat-by-beat how to use the software. (Broadband or DSL high-speed connection required.)

LX® Event Software Features Compatible with all telephonic Event Recorders

Telephonic or microphone transmission available for all event recorders.

Many additional features for DR200 users

DR200 users have the added benefits of automatic event detection, event labels and time/date stamped, automatic transmission speed detection, and SD Card transmission of ECG data.

Complete kit supports three transmission modes

Each software kits includes a telephone interface unit that can be used for telephone (FM modulation) or local microphone recording. An SD Card and SD Card reader are included for DR200 SD Card transmissions.

Filter and adjust ECG data to improve analysis and output

ECG data may be adjusted for gain, high and low pass filters. The ECG data can also be inverted and scaled in time and size in order to make the interpretation of ECG data cleaner and more accurate.

Multiple measurements and cursors available for reporting strips

Ten unique cursors (P, I, Q, R1, R2, S, ST, T, X AND Y) and five automatically calculated parameters (PR, QRS, QT, SR, HR) illustrate the strips and facilitate the most accurate reports. Strips may also be labeled.

LX® Event System Requirements Microsoft Windows XP Processor Speed of 1 GHz or faster At least 256 MB of memory (512 MB recommended) Monitor resolution of at least 1280 X 1024 At least 10 GB of available disk drive space Standard analog (POTS) phone line for receiving telephonic transmissions

Customizable reports

Report may be customized with your contact information and logo and consist of saved strips, with or without full disclosure.

Laser printer recommended

Searchable patient data base

Locate patients rapidly by a number of criteria - name, date of birth, phone, referring physician - with several search capabilities - begins with, contains or wildcard.

Distributed by:

Industry-leading 3-year warranty

Includes Hot line support and software updates during Warranty period. eMSA (extended Maintenance and Service Agreement) available.

FDA K061293 NB: In the U.S.A., Federal Law restricts devices to sale by or on the order of a physician. For in vitro diagnostic use. Not intended to replace realtime telemetry monitoring for patients suspected of having life-threatening arrhythmias. May, 2007

NorthEast Monitoring, Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754 U.S.A. www.nemon.com

phone: 978-461-3992 fax: 978-461-5991 toll free: 866-346-5837

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NorthEast Monitoring, Inc. advancing Holter technology™

DR181 Digital OxyHolter ® Recorder, 3CH Meets EC-38 standard

Saturated Oxygen Analysis

 Ergonomic design  Proven reliability  Maximize Holter reimbursements  Reduce artifact with shielded cables  Pacemaker detection standard  Foreign language interfaces  Industry-leading 3-year warranty

The DR181 is the latest version of the reliable and popular DR180 series.

With synchronized sets of data -- cardiac (standard Holter) and pulmonary (saturated O2 levels via pulse oximetry), the OxyHolter® represents a quantum step in your ability to isolate or correlate cardiac and pulmonary issues. OxyHolter® includes a specially designed, proprietary, active-electronics Holter-and-pulse-oximetry cable and an extra 5- or 7-lead cable.

DME’s (in conjunction with IDTF’s and medical professionals) use OxyHolter® to

substantiate or “fine tune” beneficiary’s oxygen requirements. With an accurate tool like OxyHolter®, O2 levels are optimized to determine replenishment schedules. The savings derived drop directly to the “bottom line” of a DME provider and quickly provide an ROI for OxyHolter®.

OxyHolter® is designed with the following three goals in mind: ease-of-use for the

patient and clinician, accuracy of data and durability of the unit. Large programmable soft-keys, easy-to-read, multi-line LCD and several foreign language options are among the features that distinguish this “tried and true” unit.

OxyHolter® performs as well in a small practice as in a large clinic or full service

(scanning) providers. Built-in safeguards insure deployment with sufficient battery levels, highquality lead hook-ups and complete patient ID.

All units are rugged and built to last. They carry the industry’s best warranty of 3 years,

along with optional extensions to 5 or more years. Choose the best unit for your application.

A number of key features make these units the quality and technology leader in the

industry today. Contact NorthEast or read on for more details.

DR181 OxyHolter ® Features

A New Approach for Evaluation and Management of Cardio-Pulmonary Diseases

Meets EC-38 standard Meets applicable sections of ANSI/AAMI ED38-1994 “Ambulatory Electrocardiographs.”

Proven reliability Hundreds of Holter units are in use worldwide. Real-world experience is designed into every unit.

DR181 OxyHolter ® Specifications Recording duration:

72 hours, with lithium batteries 48 hours, with alkaline batteries 24 hours, with rechargeable batteries

Recording bandwidth: 0.05 - 70 Hz

Resolution:

Manage O2 therapy and screen for sleep disorders

Twenty-four hours of SpO2 data correlated with 2 channels of cardiac data allow quantitative observations (value and trend) of response to O2 variations. Proprietray tool removes artifact from HR and O2 data.

Cable options May be used with Oxymetry (oxy plus 5-lead), 5-lead, or 7-lead cables.

12-bit, 12.50 µV/LSB

Prefilter sampling rate: 1440 samples/second

Dimensions:

12.3 cm x 7.0 cm x 2.4 cm (4-7/8 in x 2-3/4 in x 1.0 in)

Weight:

1 84 grams (6.5 oz.),with batteries and SD card; 136 grams (4.8 oz.), without batteries

Power:

2 AA batteries: alkaline, rechargeable or lithium

Storage capacity:

32 MB - 2 GB SD flashcard

Distributed by:

All digital recording Reliable digital technology is used throughout, enhancing service life and lowering total cost of ownership.

Compatible with NorthEast LX® Analysis software

FDA K004007 NB: In the U.S.A., Federal Law restricts devices to sale by or on the order of a physician. For in vitro diagnostic use. Not intended to replace real-time telemetry monitoring for patients suspected of having life-threatening arrhythmias. June, 2011

NorthEast Monitoring, Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754 U.S.A. www.nemon.com

phone: 978-461-3992 fax: 978-461-5991 toll free: 866-346-5837

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NorthEast Monitoring, Inc. advancing Holter technology™

LX ® Sleep Software Where would you rather sleep? OxyHolter plus LX® Sleep ep exceeds accuracy ® Sle of ECG-only LX s e i d analysis stu r e h Ot  90+% sensitivity and specificity Let LX® Sleep be the answer to your dreams with in-home, for OSA in overnight, unattended, multi-parameter, sleep study for detection preliminary of OSA (Obstructive Sleep Apnea) studies This convenient HST (Home Sleep Test) device provides a conforming methodology for multi-parameter,  overnight, unattended sleep study that is described in CMA’s NCD (National Coverage Decision) CAGLess than 1/3rd 00093R2. LX® Sleep software applies proprietary algorithms to data collected by NorthEast’s OxyHolter the cost of a full to provide a simple alternative to the PSG sleep lab experience to accurately identify OSA (Obstructive Sleep Apnea). PSG study LX® Sleep defines epochs of normal versus SDB (Sleep Disordered Breathing). Then it performs  pattern recognition on ECG and SpO2 signals; and applies a linear discriminant analysis and an ageEpoch-driven based classifier to derive an AHI (Apnea Hypopnea Index). An AHI < 5 represents no clinically significant analysis, pattern apnea; 5 ≤ AHI < 15 represents mild apnea; AHI ≥ 15 represents moderate-to-severe apnea.* recognition and Current users of Holter LX® Analysis and/or the tried-and-true DR180+ can easily add the LX® Sleep classifiers provide software option and an OxyHolter cable, thereby creating the most accurate, easy-to-use OSA detection system on the market today. AHI (Apnea *As per Decision Memo for Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea (OSA) (CAG-00093R2); March 13, 2008. Hypopnea Index) Sleep Apnea Screen for Ambulatory Holter/Oximetry  Improve per bed revenue in sleep labs  The first step to relieve symptoms of OSA  Integrated, add-on software to Holter LX® Analysis  Industry-leading 3-year warranty

LX ® Sleep Software Benefits

OxyHolter plus LX® Sleep exceeds accuracy of ECG-only analysis

Earlier systems from other vendors only utilized the ECG signal to assess OSA. Combined analysis of ECG and SpO2 yields better correlation with simultaneously collected, full PSG study data. HST method yields more accurate results with a reduced “white coat effect” by sleeping at home rather than in an unfamiliar, lab environment.

90+% sensitivity and specificity for OSA in preliminary studies

In the many preliminary studies that compared the diagnostic accuracy for OSA using simultaneously collected data from full PSG studies to data collected with OxyHolter and analyzed with LX® Sleep, results showed from 90 - 100% specificity / sensitivity.

Single unit for both SpO2 and ECG AHI gives accurate probability of OSA Improve outcome for Pillar (palatal implant) surgery Improve revenue per bed with higher percentage of CPAP titration procedures

Achieve higher patient compliance by using HST (Home Sleep Test) Less than 1/3rd the cost of a full PSG study procedure Full PSG (sleep lab) studies require enormous facility, staff and equipment resources. Compare that with the simplicity of an at-home study with a Lower cost than PSG lab single unit recorder for ECG, SpO2 and derived respiratory signals. For detecting OSA, which accounts for the overwhelming percentage of sleep Appropriate for most OSA patients studies, LX Sleep is the economical alternative.

Key Features

Epoch-driven analysis, pattern recognition and classifiers provide AHI (Apnea Hypopnea Index)

Unique algorithm combines ECG Data intervals called epochs are defined. Direct measurements on the and SpO2 for accurate AHI ECG signals are made and EDR (ECG-Derived Respiratory) signals are calculation developed. Pattern recognition and a set of age-dependent classifiers are used to develop the AHI. Convenient in-home, multiparameter sleep study

Improve per bed revenue in sleep labs

Sleep labs can be filled with higher reimbursement, CPAP titration procedures rather than preliminary OSA detection procedures.

The first step to relieve symptoms of OSA

Detection is the first step. After that, your medical professional can recommend any of a variety of remedies – from passive sleep aids, to CPAP arrangements, and perhaps corrective surgery.

Integrated add-on software to Holter LX® Analysis

Add LX®Sleep to Holter LX®Analysis for the best in graphical display and report generation of ECG, SpO2, AHI and a number of other parameters.

 Industry-leading 3-year warranty

Includes Hotline support and software updates during the Warranty period. eMSA (extended Maintenance and Service Agreement) available.

Distributed by:

Fewer wires/probes means easy to connect Non-volatile data storage - fewer repeat studies Displays combine graphical SpO2 and ECG data Exceeds Type IV device requirements

Availability

Easy add-on to Holter LX® Analysis software Works with OxyHolter (DR180+ with integrated oximetry cable) Free updates with 3-year Warranty and/or 2-year eMSA

FDA K081861 Indications For Use: This device is intended for use on adult patients to determine the need for clinical diagnosis and evaluation by polysomnography based on the patient’s score. NB: In the U.S.A., Federal Law restricts devices to sale by or on the order of a physician. For in vitro diagnostic use. Not intended to replace realtime telemetry monitoring for patients suspected of having life-threatening arrhythmias. January, 2009

NorthEast Monitoring, Inc. Two Clock Tower Place, Suite 555 Maynard, MA 01754 U.S.A. www.nemon.com

phone: 978-461-3992 fax: 978-461-5991 toll free: 866-346-5837

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