Система диагностическая для полисомнографии, модели: Embla N7000, Embla S7000, Embletta… — инструкция и характеристики, РУ РЗН 2015/2294 | TenderMatch

Система диагностическая для полисомнографии, модели: Embla N7000, Embla S7000, Embletta PDS, Compass с принадлежностями — инструкция и характеристики

РУ: РЗН 2015/2294 от 15.11.2004 · класс риска 2а

Производитель: "Ембла Системс" (Канада)

Автоматически отфильтрованный фрагмент инструкции по применению (страницы, где похоже, что есть таблица технических характеристик) — не полный документ. Карточка РУ на портале Росздравнадзора →

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Текст инструкции: технические характеристики

--- стр. 1 ---
Medcare
S m ar t S leep  S y s te m s
Pathway Programs


--- стр. 2 ---
Medcare
Pathway Programs
Medcare
Compass
Sleep Clinic
P atie nt In fo rm a tio n
last Mame: Doe
RrstNeme: >ahn
Pa&enlID: 1234S6789
Address: Address 123
Oty: 5Э2ЭЗ Large Town. TR
Ptione: 5423438096
K to r d tn g  I n f f v a l
___________________
Date: 29.3.2003
Start Б т е : 22:22:27
S toplVne: 06:02:22
Duratton: 4S9,9 minutes
Indteee
Average Putse Rate; 
E vent Count
Gender:
Date of Birtti:
H e ^ W :
We*ght;
B M lr
A w a lyte d In te rv a l
Start Time: 22:23:16
StopTkne: 06:02:22
Duraoon: 459,1 mtrHHes
Est. Rest Time: 448,5 minutes
Apneas:
O bstnjcB w e A pneas: 
C entrW M taad A im e as. 
Hypopneas: 
Oesaturations;
RMI Periods: 
Paradojrtcal Periods: 
Breaths:
Com m ents
Pted^ D O te ttiis [Client's AH I.
R e p o rt P n n M d  I9 .3 .2 0 0 <  I
Example Report
There is great demand for the diagnosis and proper 
identification of patients that could potentially have sleep 
disordered breathing. Physicians and medical professionals 
need efficient means to be able to properly determine the 
possibility of sleep disordered breathing (SDB). Medcare's 
unique Pathway Programs offer precise, yet easy to use 
systems for detecting SDB with flexible components to fit 
every environment.
■  Detect Sleep Disordered Breathing
• Detect snoring
■  Detect breathing instability
■  Differentiate between central and obstructive apnea
■  Use the activity and position sensor to estimate rest time
■  Record oximetry optionally
■  Simple and easy to use
■  Minimize need for training
■  Download, analyze and report in under 3 minutes
Components
Medcare knows one solution does not fit all. Pathway 
Programs feature a variety of components and options to suit 
your needs for detecting, diagnosing and controlling therapy 
of sleep disordered breathing. Plus, these components have 
all been designed to be comprehensive but incredibly easy to 
use. This means less time spent on training and using the 
system. The components come with a detailed written manual 
and a helpful hook-up card for patients. The software also 
simplifies the process with an intuitive user interface featuring 
familiar tasks. This makes it easy for anyone to use the 
software.
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DoATtload e study from the 
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been downloaded to your 
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The C om pass Start Screen
The Compass Software
The Medcare Compass Software is used to prepare the 
Compass recorders, download and analyze the study. It 
introduces a new type of user interface, designed for a 
simple and efficient workflow. By building on Medcare’s 
strong software technology, this software frees up your time 
and lets you focus more on the patient. You can download, 
analyze, and make a report in less than 3 minutes. Plus, 
our proven analysis algorithms can analyze the recordings 
provided by the Compass recorder.
The Compass Recorder
The Compass lightweight recorder uses a quick, USB 
download and provides the most ergonomic solution for you 
and your patient. There are two models available.


--- стр. 3 ---
This recorder is ideal for detecting Sleep Disordered 
Breathing, differentiating between central and obstructive 
apnea and using RMI to indicate patient breathing instability. 
The M 10 is also a perfect fit for therapy control studies as flow 
is detected through the XactTrace RIP belts.
This device is based on respiratory movement acquired with 
Medcare's XactTrace RIP belts. It records thoracic and 
abdominal movement, position, activity, RMI and XFIow. 
Medcare's patent-pending RMI parameter gives an indication 
of a patient’s breathing stability while XFIow is a semi- 
quantitative measure of inspiratory and expiratory flow derived 
from XactTrace.
Compass F10
This recorder is ideal for detecting SDB, snoring and using the 
flattening index to indicate flow limitation in the upper airway.
This device is based on nasal flow acquired with Medcare's 
nasal cannula. It also records snoring, position, and activity.
Compass M10
■  Extensions
■  Compass Oximeter Option: Both devices offer the option 
of connecting an oximeter to complement the recording. 
The Compass oximeters also connect to ResMed ResLink 
technology.
■  Compass M10 Pediatric Option: The Pediatric Option 
includes Medcare's disposable XactTrace belts to fit small 
individuals and children.
■  Compass M10 Custom-Fit Belt Option: The Custom-Fit 
Belt Option includes Medcare’s disposable XactTrace belts 
plus velcro straps to better suit patients of various sizes.
Recorded Signals from Compass M10 & Optional Oximeter
Abdominal Movement 
Thoracic Movement 
XFIow 
Activity 
Position 
S p02 Quality 
S p02 Beat-to-Beat 
Plethysmograph 
RD Quality 
Sp02
Recorded Signals from Compass F10 & Optional Oximeter
Nasal Pressure 
Nasal Flow 
Flattening 
Snore 
Activity 
Position 
S p02 Quality 
S p02 Beat-to-Beat 
Plethysmograph 
RD Quality 
Sp02


--- стр. 4 ---
Medcare
Pathway Programs
S mart  S l e e p S y st e m s
■ Detect Sleep Disordered Breathing
■ Detect snoring
■ Detect breathing instability
■ Differentiate between central and obstructive apnea
■ Use the activity and position sensor to estimate rest time
■ Record oximetry optionally
■ Simple and easy to use
■ Minimize need for training
■ Download, analyze and report in under 3 minutes
• \
■ VV/
Compass systems are manufactured by Medcare Flaga, Reykjavik, Iceland. The manufacturer works in 
accordance with ttie EN ISO 9001 and EN ISO 13485 quality system and has the authority to mark the 
products with the CE mark The CE mark is a declaration that the device is in compliance with the directives set 
forth by the European Union for medical devices, in particular the fVIDD annex VII.
Compass is a Class lla device according to Medical Device Directive (MOD), Annex V , "EC Directive" 
93/42/EEC and Swedish implementation of the directive LVFS 2001:6. Certificate No. 41311838.
Compass. XactTrace and Pathway Programs are trademarks of Medcare Flaga
Medcare Flaga SIdumull 24, 108 Reykjavik. Iceland Tel: +354 510 2000 Fax: +354 510 
2010 • (Medcare GmbH Argelsrieder Feld 11, 82234 Wessling, Germany Tel:+49 (0) 
8153-90666-30 F a x:+49 (0) 8153-90666-31 • Medcare Flaga Kon. Wilhelminaplein 13, 
1062 HH Amsterdam, The Netherlands Tel: +31 20 346 0130 Fax: +31 20 346 0121 • 
Medcare Systems, Inc 55 Pineview - Suite 100, Buffalo, NY 14228 U.S.A. Tel: +1 (716) 
691 0718 Fax: +1 (716)691 1004
For further Information, see www.medcare.com or contact sales@medcare.com
www.medcare.com


--- стр. 5 ---
Medcare
S m ar t S leep  S ystem s


--- стр. 6 ---
The Embletta® is a pocket-sized digital recorder that is a 
complete system for diagnosis of sleep disordered breathing 
(SDB) in the sleep clinic, hospital, or home. With its advanced 
diagnostic features and the Somnologica for Embletta software, 
the Embletta is a highly sensitive, yet cost effective, method for 
diagnosing SDB.
Embletta: A T ruly Flexible System
The Embletta offers unmatched diagnostic accuracy in a 
lightweight, compact design that is certainly easy to use. 
Powered by two alkaline or rechargeable batteries, the 
Embletta has an internal flash memory that can store 
comprehensive respiratory data. The Embletta can be adapted 
to a variety of ambulatory and online studies by using its 
variable proxy connections. It can also be attached to flow 
generators to determine the efficacy of treatment. The 
Embletta can be directly connected to a ResMed AutoSet flow 
generator where flow, pressure, leak, and events from the 
AutoSet are added to the signals recorded by the Embletta. 
Embletta provides an outstanding SDB diagnostic solution. 
Exact nasal flow and pressure snore signals are obtained via a 
nasal cannula. Other signals that complete the diagnostic 
accuracy are position and activity, leg movement, oxygen 
saturation, pulse, oral flow, and last but not least, two 
respiratory effort signals through the XactTrace Respiratory 
Inductive Plethysmograph (RIP) sensors.The Embletta also 
features an event button.
Som nologica fo r Embletta
E m b letta
Somnologica for Embletta is a state-of-the-art software 
application that enhances the professional's ability to study and 
diagnose SDB more precisely. With its highly developed user 
interface, the software streamlines the steps in the sleep study 
process. Among its key features is an Operations Sheet that 
clearly guides you through preparing the device, downloading, 
analyzing recordings, and then creating reports. Somnologica 
for Embletta offers quality automatic respiration and Periodic 
Limb Movement (PLM) analysis. Somnologica for Embletta 
allows the analysis parameters to be set and reports 
customized. It even allows you to use hot keys to manually 
score and edit a study. The report function summarizes the 
analysis and includes descriptive graphics of the night's 
events. The Sleep Report gives detailed information on 
respiration events, including statistics, graphs, and tables. The 
AutoSet Report summarizes therapy results while PLM 
information is added to the Sleep Report. The Recording 
Manager organizes your patients and studies, while the Device 
Manager detects individual devices and their status. Embletta 
recordings can also be analyzed with Somnologica Studio, the 
Embla software, offering additional capability and flexibility.
■ Data Management Module
The Data Management Module helps you maintain and 
manage your patient records. The module enables you to store 
and easily access clinical outcomes and patient information. 
Flexible search features allow you to quickly locate patient 
groups or records of inerest, enabling you to assess trends or 
target areas for intervention.


--- стр. 7 ---
■ XactTrace тм
The XactTrace Respiratory Inductive Plethysmograph (RIP) is 
an important addition to the Embletta system for increased 
quality of respiratory effort measurement. The XactTrace 
sensor generates a high quality signal that Is a measure of the 
chest/abdomen circumference. This signal gives a qualitative 
measure of ventilation and flow. The XactTrace delivers a 
highly sensitive and reliable tracing. Conveniently, the 
XactTrace belts can be custom fit to each patient. These belts 
are very hygienic and user friendly and are available both in 
single use and reusable versions.
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■ Limb Movement
The Embletta can measure limb movement activity to help in 
the diagnosis of Periodic Limb Movement Disorder (PLMD). 
The Somnologica for Embletta software automatically analyzes 
the EMG signals and detects leg movements and PLM 
sequences. Information about PLM is added to the reports if 
this signal is recorded.
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Em bletta Setup


--- стр. 8 ---
Online Interface
The Embletta Online Interface allows an attended, online study 
with the Embletta. The Online Interface connects the Embletta 
to a computer and has a quick-release connector which allows 
easy disconnection from the computer. The online solution 
provides the same parameters as the Embletta diagnostic 
studies. With the Online Interface it is possible to view the 
signals online while recording and to monitor mask pressure 
during a CPAP study.
AutoSet Interface
The Embletta AutoSet Interface connects the Embletta to 
ResMed's AutoSet flow generator. The AutoSet is an automatic 
titration device for the treatment of Obstructive Sleep Apnea 
(OSA). The AutoSet technology is a patented algorithm that 
responds to a variety of parameters, including the inspiratory 
flow-time curve, the most reliable way to detect impending 
upper airway collapse. The Embletta AutoSet Interface sends 
the digital information about the inspiratory flow-time curve, as 
well as AutoSet pressure, snore, and leak to the Embletta. 
These data are stored with the other signals Embletta records 
and help verify the effectiveness of treatment. The AutoSet 
Report in Somnologica for Embletta summarizes the data 
acquired from both devices.
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Flow Interface
With the Flow Interface the Embletta becomes an invaluable 
tool in determining the effectiveness of a CPAP or ventilation 
therapy. The Flow Interface is simply attached to the CPAP 
tubing and works with any type of flow generator. The Flow 
Interface also fits to all conventional mask types. No additional 
sensor is needed under the nasal mask, securing maximum 
patient comfort and the protection against leak.
AutoSet Report
Flow Interface


--- стр. 9 ---
Operation Sheet
Workpad Area
ihSimBi N U M
■ Diagnose more accurately with Embletta's exceptional SDB 
diagnostic features;
■ nasal flow and snoring from cannula (pressure transducer)
■ 2 respiratory effort signals (XactTrace or Piezo)
■ oxygen saturation and pulse
■ oral flow from thermistor
■ PLM Periodic Limb Movement (optional)
■ built-in 3D body position and activity sensor
■ 9 physiological channels to 16 traces in total
■ Simplify data collection and data download with Embletta's 
large internal flash memory
■ Maximize resources with Embletta's full ambulatory capability
■ Enhance patient comfort with the lightweight design
EMBLETTA’S COMPLETE SYSTEM;
■ Features the highly developed Somnologica for Embletta 
interface that guides you through the sleep study process
■ Employs Somnologica for Embletta's automatic respiration 
analyzer and allows manual analysis and editing
■ Benefits from a more exact respiratory effort with the XactT race 
Respiratory Inductive Plethysmograph (RIP)
■ Detects your patient's leg movements with the PLM sensor
■ Confirmstheefficacyoftreatment using the AutoSet Interface
■ Determines the effectiveness of a CPAP or ventilation therapy 
using the Flow Interface
■ Quickly searches for patient groups or records of interest by 
using the Data Management Module


--- стр. 10 ---
S mart  S l e e p S y st em s
EMBLETTA MEASURES 
Flow/Pressure (nasal cannula/mask)
Oral flow (thermistor)
Snore (by nasal pressure or by neck vibration sensor Piezo element) 
Abdominal movement (by XactTrace RIP belts or by Piezo element sensors) 
Chest wall movement (by XactTrace RIP belts or by Piezo element sensors) 
Sp02 average (oximeter)
Sp02 beat-to-beat (oximeter)
Pulse rate (oximeter)
Pulse waveform (oximeter)
Body position 
Flow limitation 
Event marker 
Activity
Limb Movement 
AutoSet information
Embletia systems are manufactured by Medcare Flaga. Reykjavik, Iceland. The manufacturer works in 
accordance willi itie ISO 9002/EN 46002 quality system and has the authority to mark the products with 
the CE mark (CE 0413). The CE mark Is a declaration that the device is in compliance with the directives 
set forth by the European Union for medical devices, in particular the MDD annex VII.
Embletta is Class lla device according to Medical Device Directive (MDD), Annex V, "EC Directive" 
93/42/EEC. Embletta has been tested and certified by SEMKO to comply with; EN 60601-1.1990 with A1 
andA12-1993.A2-1995andA13;1996. (lEC 60601-1, Second edition, 1988 with A1,1991 andA2, 1995), 
EN60601-1-2: 1993, EN55011;1990, EN 55 014-1:1993, EN60601-1-4, EN 865-1997, lEC 801-2, ed.2: 
1991. lEC 801-3 draft 1992. lEC 801-4:1998. lEC 61000-4-5:1995, UL2601 2,Ed 1997. CAN/CSAC22.2 
No.601 1-M90
Embletta and Embla are registered trademarks of Medcare Flaga Somnologica is a trademark of Medcare 
Flaga. AutoSet is a trademark of ResMed Ltd
Medcare Flaga Vesturhlid 7.105 Reykjavik, Iceland Tel: +354 510 2000 Fax: +354 510 
2010 • Medcare Flaga Ottho Heldringstraat 27, 1066 XT Amsterdam, The Netherlands 
Tel: +31 20 346 0130 Fax: +31 20 346 0121 • Medcare Systems, Inc 435 Creekside Dr., 
Buffalo, NY 14228 U.S.A. Tel: +1 (716)691 0718 Fax: +1 (716)691 1004
For further information contact your local sales representative or contact sales@medcare.is
www.medcare.is


--- стр. 11 ---
Medcare
S m ar t S leep  S ystem s


--- стр. 12 ---
The Embla® Recording Systems are developed and designed 
based on a decade of experience in the field of sleep technology. 
These systems offer a high degree of flexibility and signal quality 
to meet the highest demands of clinical work and research.
The Embla recorders are indispensable in a wide range of 
clinical and research settings that require maximum flexibility 
and efficiency in data collection.
By providing a comprehensive lab-based and portable 
application in one dynamic recorder, these devices maximize 
your investment.
The Embla recorders all use the Somnologica™ software, 
which is designed to meet the needs for flexibility in research 
and ease-of-use in clinical work.
Embla Recording Systems
Embla Recording Systems represent an integration of 
advanced digital technology and precision engineering into 
ergonomically designed PSG and EEG systems.
Embla is available in a number of different configurations; 
Designed for the dedicated high-performance sleep center. It 
offers a comprehensive array of patient, bedside and 
communication units to perform PSG and full EEG studies with 
ease.
Offering extended referential recording capability, bipolar, 
respiratory and DC-level inputs. Suitable for both routine and 
extended sleep protocols, the Embla systems enable you to 
expand your services and record full EEG.
Designed for EEG and polygraphic applications in clinical and 
research settings, the same recorder can be used in laboratory 
and ambulatory recordings. Its compact size allows the 
recorder to be easily carried by the patient.
Embla S 7000 Bedside Unit
Streamlined Design
The patient interface of the Embla Recorder consists of the 
Bedside Unit and the Patient Unit. Both are lightweight and 
feature quick-disconnect for easy patient mobility.
The clinically enhanced Patient Unit greatly reduces the cabling 
for signals such as respiratory effort, snoring, flow and Sp02. 
Worn by the patient, problems with tangled cables are eliminated. 
For routine EEG applications, the Patient Unit can be 
disconnected from the Bedside Unit and not used.
The Bedside Unit is lightweight and can be comfortably worn by 
the patient with a strap attachment.
A mobile stand or mounting bracket provides mobility and 
stability.
The Embla recorders share recording capabilities and 
performance-packed features.
Featuring from 12 up to 32 referential channels (EEG, EOG,...) 
Reference can be any single electrode or the common of any 
number of electrodes. Easily switched during acquisition.
8 bipolar channels for physiological signals such as EMG and 
EKG.
9 respiratory channels that include a built-in pressure transducer 
with steel luer lock, precise, 3-dimensional analysis of body


--- стр. 13 ---
Patient Environment
position and nnovement, integrated oximetry with averaged 
S p02, beat-to-beat S p02, Pulse, Pulse w aveform  
(Plethysmograph), Respiratory Inductive Plethysmography 
(RIP), snoring, patient event marker and more.
8 auxiliary DC channels for interfacing other critical signals, such 
as ETC02.
Serial connectivity for devices with digital outputs, such as CPAP.
I  nterface for electrode caps.
Built-In Functions that Make a Difference
Device-integrated impedance function with illuminated display 
provides quick and easy bedside measurements.
Easily accessible event buttons allow the caregiver or patient to 
enter time-stamped event entries.
Integrated Ambient Light Detector registers ambient light 
changes in the patient environment.
The Connection that Counts
The Embla systems set the standard by utilizing an ethernet 
network to speed clean and reliable signals to the viewer in a 
variety of recording environments.
Using standard networking technologies changes the 
paradigm for delivery of services by opening a wide area of 
Ethernet connectivity options including your existing LAN, 
dedicated sleep lab LAN, wide area networks (WAN) and 
wireless networks. The Embla devices optimize facility 
operations and can be moved to new locations within the 
network environment with ease.
Not tied to the limitations of cabling, the Embla Ethernet 
interface integrates more easily into even the most complex 
recording situations.
Somnologica™ Studio will automatically detect Embla 
recorders regardless of where they are moved within the 
network.
Somnologica Studio will automatically resume the recording if 
the recorder is moved in the middle of the recording.
Ethernet is a very well established, reliable technology that is 
cost effective and easy to maintain.
Embla Ambulatory Systems
The Embla ambulatory recording systems are truly flexible. 
Designed for EEG and polygraphic applications in clinical and 
research settings, the same recorder can be used in laboratory 
and ambulatory recordings. Its compact size allows the 
recorder to be easily carried by the patient.
Embla A10
Designed for Optimal Flexibility
The Embla ambulatory recorders are customized in software. 
With configurable sensor settings, you can define custom


--- стр. 14 ---
settings for almost any sensor available. This innovative 
design enables the recorder to be used in a variety of 
settings including on-line partial polysomnography, full 
polysomnography recording, or ambulatory EEG.
The Embla Amubulatory recorders can collect data from:
16 multipurpose channels 
Event button channel
2 oximeter channels 
4 auxiliary channels
The data from the Embla is either recorded directly Into 
Somnologica during on-line acquisition or downloaded to 
Somnologica from PC-Cards after ambulatory studies.
Som nologica Studio
Somnologica Studio is the performance powerhouse at the 
heart of all Embla systems and is designed for both clinical and 
research applications. Proven in hundreds of locations 
worldwide, Somnologica Studio provides solutions with a 
comprehensive array of tools that streamline workflow and 
improve patient data management.
Work confidently with the proven and powerful capabilities of 
the Windows N T , 2000""or XP''operating systems.
Navigate easily and perform a sleep study in obvious steps 
using the Operation Sheet.
Optimize your time by using tools that provide superior analysis 
power and scoring speed without compromising accuracy. 
Recording review is fast and easy with dynamic review tools 
that include montage reformatting, reference switching, re­
filtering, and page companson.
Get the results you need with flexible report options that include 
customizable reports and versatile export tools.
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Somnologica Operation Sheet
Expand Your System Capabilities
To further enhance your system, you can add other options to 
create a complete and integrated system:
Add the Data Management Module to help you keep track of 
your patients. It provides convenient access to patient 
information and flexible search features. This allows you to 
quickly locate patient groups or records of interest, enabling 
you to assess trends or target areas for intervention.
Add Synchronized Digital Video to your Embla system for 
enhanced data analysis.
Expand your services by adding the Embletta® PDS recorder 
fordiagnosing sleep-disordered breathing.
Take advantage of the latest technology with Xact products. 
The product line includes the XactTrace Respiratory Inductive 
Plethysmograph (RIP), the Embletta Xact AutoSet Interface 
and the Embletta Xact LM module.
Expand to the Somnologica Science platform to meet your 
advanced research needs.
Future-Proof Your Investm ent
Embla's industry-leading engineering expertise makes the 
latest innovations in digital technology available with 
integrated, modular system components.
Embla systems represent the most comprehensive, multi­
application array of sleep and sleep/EEG products available 
today. Designed with your success in mind, the Embla systems 
ensure that your needs are covered today and beyond with 
superior, proven products that work for you.
For more information on how Embla products can meet all of 
your PSG and PSG/EEG needs, contact your local 
representative.


--- стр. 15 ---
Embla Communication Unit
Controls the system and facilitates 
network communication.
Standard RJ45 Ethernet connection for 
connecting to your local network
8 isolated auxiliary channels, for 
external devices, such as ETC02
2 isolated serial ports for external device 
communications, such as CPAP
Embla Patient Unit
Smart, efficient recording of respiratory 
parameters
9 respiratory channels 
Oximetry
Flow/Pressure (nasal cannula/mask) 
Flow limitation 
Oral flow
Snore (by nasal pressure or by neck 
vibration sensor)
Abdominal movement (by XactTrace 
RIP belts or by Piezo element sensors) 
Chest wall movement (by XactTrace 
RIP belts or by Piezo element sensors) 
Sp02 averaged, Sp02 beat-to-beat, 
pulse rate, pulse waveform (oximeter) 
Event marker 
Body position / Activity
Embla N  7000
Polysomnography with extended EEG
capabilities
Up to 60 channels
Bedside Unit
32 referential channels (EEG, EOG,...)
8 bipolar channels (EKG, EMG, Legs,...) 
Amplifier re-referencing during acquisition 
Integrated impedance test 
Accessible event button 
Integrated ambient light detector 
Wide range of selectable sampling rates 
Interface for electro-cap 
Quick release
Embla S 7000
Polysomnography for sleep centers 
Up to 40 channels
Bedside Unit
12 referential channels (EEG, EOG,...)
8 bipolar channels (EKG, EMG, Legs,...) 
Amplifier re-referencing during acquisition 
Integrated impedance test 
Accessible event button 
Integrated ambient light detector 
Wide range of selectable sampling rates 
Quick release


--- стр. 16 ---
S mart  S l e e p S y stem s
Get what you need with a clinically streamlined design
Use modular configurations of up to 60 channels
Enjoy flexibility; sleep studies by night and EEG studies by day
Simplify with ergonomically arranged system components
Plug into existing network infrastructure to minimize installation costs
Facilitate wireless networking with Ethernet connectivity
Increase ease and comfort with minimal cabling and connections
Detach smoothly and quickly when leaving bed
Run a device-integrated impedance test effortlessly
Acquire high quality signals
Work with the industry-leading Somnologica Software
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Embla systems are manufactured by Medcare Flaga, Reykjavik, Iceland The manufacturer works in 
accordance with the ISO 9002/EN 46002 quality system and has the authority to mark the products with 
the CE mark (CE 0413). The CE mark is a declaration that the device is In compliance with the directives 
set forth by the European Union for medical devices, in particular the MDD annex VII.
Embla AY10 is tested and certified by DEMKO to comply with EN 60601-1. Embla N7000 and S7000 are 
tested and certified by SEMKO lo comply with EN 60601-1 standard of electrical safety of medical 
devices. Embla N7000 and S7000 are also certified and tested to comply with EN60601-1-2, UL 2601-1, 
CAN/CSA-C22.2, N0.601 1-M90, AS/NZS 3200-1-0.
the MDD annex VII.Embletta and Embla are registered trademarks of Medcare Flaga. Somnologica is a 
trademark of Medcare Flaga AutoSet is a trademark of ResMed Ltd.
i
Medcare Flaga Vesturhlid 7, 105 Reykjavik, Iceland Tel; +354 510 2000 Fax: +354 510 
2010 • Medcare Flaga Ottho Heldringstraat 27, 1066 XT Amsterdam, The Netherlands 
Tel: +31 20 346 0130 Fax: +31 20 346 0121 • Medcare Systems, Inc 435 Creekside Dr., 
Buffalo, NY 14228 U.S.A. Tel: +1 (716)691 0718 Fax: +1 (716)691 1004
For further information, see www.embla.corn or contact 
sales@medcare.is in Europe or sales@medcare.us in the USA.
www.medcare.is