Norav Medical NR-1207-3 Operating instructions

NR Recorder
Model NR-1207-3
Installation and Operation Guide
(for iOS Devices)
Doc P/N: 2018-005|Norav Medical Revision 2.0 Updated 16/12/1

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Copyright
Copyright © Norav 201 . All rights reserved. Doc P/N: 2018-005
No part of this publication may be reproduced in any material form (including photocopying or storing it in any
medium by electronic means whether or not transiently or incidentally to some other use of this publication)
without the prior written permission of the copyright owner, or under the terms of a license issued by the
copyright owner.
iPad, iPad Air, iPad mini, iPad Pro and iPhone are trademarks of Apple Inc., registered in the U.S. and other
countries. “Made for iPhone,” and “Made for iPad” mean that an electronic accessory has been designed to
connect specifically to the iPhone, or iPad, respectively, and has been certified by the developer to meet Apple
performance standards. Apple is not responsible for the operation of this device or its compliance with safety
and regulatory standards. Please note that the use of this device with iPad, iPad Air, iPad mini or iPhone may
affect wireless performance.
The information contained in this document is subject to change without notice. Norav is neither responsible for
nor liable to anyone in connection with this document.
Contact Information
Manufactured by:
Norav Medical GmbH
Christof-Ruthof-Weg 10
55252 Mainz-Kastel
Germany
Telephone: [phone]
Faximile: [phone]
Email: [e-mail]
Standards Compliance
The interference generated by the device was tested according to the EMC 8 /336/EEC and found compliant with
the standard.
The NR Recorder conforms to Medical Devices Directive 3/42 EEC Annex II.
Complies with the Medical Device Directive of the European Union: NB. 27 7
CAUTIO
CAUTIO : US Federal Law restricts this device to sale by, or on the order of, a
physician.
The NR Recorder is tested and certified for the following standards:
■ EN60601-1
■ EN60601-2-47
■ IEC60601-11
■ Protection type and class: BF, Internally powered
■ Defibrillation protection: yes, with Banana cable only.

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Disclaimer
This system is intended as a decision support system for persons who have received appropriate medical training,
and should not be used as a sole basis for making clinical decisions pertaining to patient diagnosis, care, or
management. Any application of medical information from the program, other than the original design or intended
use thereof, is not advised and considered a misuse of the product.
orav Limited Warranty
The Norav limited warranty guarantees products free from manufacturing and material defects for a period of one
(1) year from the date of shipment from Norav or the dealer to the original purchaser.
Excluded from this warranty are expendable supply items including, but not limited to, electrodes, lead
wires, patient cables, and batteries. This warranty does not apply to any product that Norav determines that
it has been modified or damaged by the customer.
Except for the express warranties stated above, Norav disclaims all warranties including implied warranties of
merchantability and fitness. The stated express warranties are in lieu of all obligations or liabilities on the part of
Norav for damages, including but not limited to, special, indirect, or consequential, arising out of or in connection
with the use or performance of Norav products.
Any action for breach of warranty shall be commenced within one (1) year of said breach or be forever barred. Any
repairs made to the product that are not covered by the warranty shall be billed to the customer.
For service or technical support contact the local supplier or Norav Medical.
Document History
Rev. Description of Revisions Date
A Initial release 01/02/2018
1.4 Norav Mobile ECG for iOS, Version 1.4 03/01/201
1.4( ) Norav Mobile ECG for iOS, Version 1.4( ) 28/02/201
1.4(10) Norav Mobile ECG for iOS, Version 1.4(10) 24/04/201
1.4(11) Norav GmbH new address 25/11/201
2.0 Norav Mobile ECG for iOS, Version 2.0 16/12/201

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Contents
Copyright ................................................................................................................................................................... 2
Contact Information .................................................................................................................................................. 2
Standards Compliance .............................................................................................................................................. 2
Disclaimer .................................................................................................................................................................. 3
Norav Limited Warranty ............................................................................................................................................ 3
Document History...................................................................................................................................................... 3
Document Conventions ............................................................................................................................................
Safety .........................................................................................................................................................................
Intended Use .............................................................................................................................................................. 7
Indications for Use .................................................................................................................................................... 7
Contraindications for Use and Adverse effects ....................................................................................................... 7
Unpacking .................................................................................................................................................................. 8
Installing the Norav Mobile ECG App ....................................................................................................................... 9
Installing the NR Recorder ...................................................................................................................................... 10
Pairing the NR Recorder with iOS Mobile Device .................................................................................................. 13
First Time the Norav Mobile ECG App Settings ..................................................................................................... 14
Performing the ECG test ......................................................................................................................................... 1
Saving Test Results and Generating Report .......................................................................................................... 17
Tests Archive ........................................................................................................................................................... 17
Enhanced Features ................................................................................................................................................. 18

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Document Conventions
otes and Cautions
Pay particular attention at specific points in a procedure when one of the following messages appears:
WAR I G
WAR I G: Warnings call attention to possible hazards involving potential damage or
injury to
persons.
CAUTIO
CAUTIO : autions refer to practices necessary to protect against potential damage or
loss to equipment. Pay careful attention to instructions.
OTE
OTE: Notes provide pertinent information to help obtain optimum performance from
the software or signify an important step or procedure that requires special attention.
Safety
WAR I G
WAR I G: The NR Recorder device uses batteries as the main power supply. It is
also sensitive to electrical interference. To prevent possible injury, read this page
carefully prior to installing the device.
■ Other devices which are part of the system must meet the requirements of the Standard for
Information Technology Equipment (IEC 60 50) and the Standard for Electrical Medical
Devices (IEC 60601-1)
■ The computer system should be approved to the appropriate safety standard for non-medical electrical
equipment (IEC 60 50, or its national variants).
■ Computers and printers used with Medical Devices should be evaluated for EN 60 50-1, EN 60601-1 or
equivalent safety standard to maintain the safety of Medical Devices.
■ Accessory equipment connected to the analogue and digital interfaces must be certified according to the
respective IEC/EN standards (e.g. IEC/EN 60 50 for data processing equipment and IEC/EN 60601-1 for
medical equipment). Furthermore, all configurations shall comply with the valid version of the standard
IEC/EN 60601-1-1. Therefore anybody, who connects additional equipment to the signal input or output
connector to configure a medical system, must make sure that it complies with the standard. Use only the
original data cable/power adaptor assembly.
■ Magnetic and electrical fields can have an influence on the function of instruments. Ensure that all non
Norav Medical equipment which is operated nearby complies with the EMC requirements (regulations
for Electro Magnetic Compatibility). X-Ray, CTs, etc. can cause interference to other equipment, as a
result of their authorized higher emission of electromagnetic interference.
■ Pacemaker – It is recommended that a minimum separation of 15 cm (6 inches) be maintained between
the wireless NR Recorder and a pacemaker to avoid potential interference with pacemaker. Some
studies have shown that wireless devices might interfere with implanted cardiac pacemakers if used
within eight inches of the pacemaker. Pacemaker users may want to avoid placing or using a wireless
device this close to their pacemaker. Patients with a pacemaker:
• Should always keep the wireless NR Recorder unit at least 30 cm from their pacemaker when the
NR Recorder unit is turned on.
• Should not carry the NR Recorder in their breast pocket.

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If you have any reason to suspect that interference is taking place, turn off the ECG immediately.
■ Use only the recommended battery type as instructed in the technical specifications to operate the
NR Recorder (1 x AA alkaline or NiMH rechargeable battery).
■ Do not use batteries with expired dates.
■ Remove batteries form the unit (NR Recorder) when it is not in use.
■ In the event of apparent changes in the performance of the device, discontinue use immediately. Do
not resume use until the device is approved by the manufacturer or by a representative of the
manufacturer.
■ Defibrillation protection is guarantee only with original Norav supplied ECG cable (“banana” ends).
■ Operate the unit only at clinics and hospitals. Do not use at home.
■ Operation only by trained medical staff.
■ Use only with battery compartment closed.
■ This NR Recorder complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions:
• (1) This product may not cause harmful interference.
• (2) This product must accept any interference received, including interference that may cause
undesired operation.
OTE
OTE: The manufacturer is not responsible for any Radio or TV interference
caused by unauthorized modifications to this equipment. Such modifications
could void the user’s authority to operate the equipment.
OTE
OTE: Install hardware only after software installation.

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Intended Use
In conjunction with Norav Mobile ECG App the NR Recorder is intended to acquire multi-channel ECG signals from
adult and pediatric patients from body surface ECG electrodes and to record, display, analyze, and store these
ECG signals for review by the user. It is to be used by trained healthcare professionals. Analysis of the ECG
signals is accomplished with algorithms that provide measurements, data presentations, graphical presentations,
and interpretations for review by the user.
The interpreted ECG with measurements and interpretive statements is offered to the clinician on an advisory basis
only. It is to be used in conjunction with the clinician's knowledge of the patient, the results of the physical
examination, the ECG tracings, and other clinical findings.
Indications for Use
ECG device is to be used to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate
abnormalities, or features of prognostic value in adults and pediatric populations in the following cases:
■ Patients with suspected cardiac abnormalities.
■ Populations of patients at an age or period in which a routine baseline evaluation of ECG characteristics is
desired.
Contraindications for Use and Adverse effects
The device has no contraindications or adverse events.

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Unpacking
Open the device package and verify the following package content:
P/ Description
NR12073-D-00E-02 NR Recorder, model NR-1207-3
C10-B-E-EI 10 lead ECG cable for NR Recorder, banana ends, IEC, EI
C-USB-EXT-2M USB cable 2M
C-ADAPT-BANANA-SNAP-01 Banana to Snap adapters pack of 10
BAT-ALK-P-AA-EN 1 Battery, Alkaline Primary, 1.5V, Size AA
ADAPTOR-BTUSB-UD100-01 Bluetooth USB Adapter (for MS Windows PC)
ANT-2.4-RPS-MAF 4028-1 Detachable antenna for Bluetooth adapter (for MS Windows PC)
SW-CD-PCECG1200-01 Software PC-ECG 1200 CD (for MS Windows PC)
SW-CD-NR-OMINS-i-01 Installation and Operation Manual for Norav Mobile ECG iOS app (on CD)
SW-CD-NR-OM-01 NR Recorder Operation Manual (on CD)

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Installing the orav Mobile ECG App
The following Apple products running iOS 12.1 or later are supported:
iPhone XR
iPhone X
iPhone 7 Plus
iPhone SE
iPad Pro (12. -inch) 2nd generation
iPad (5th generation)
iPad Air 2
iPad Air
iPad mini 2
To install the Norav Mobile ECG app on the iOS mobile device:
1. On your iPhone or iPad go to the App Store following below link:
https://apps.apple.com/us/app/norav-medical-mobile-ecg/id14538156 6
2. When the ‘Norav Mobile ECG’ app description appears- tap Get. You might need to sign in with
your Apple ID and password or use Touch ID or Face ID if you have them set up.

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Installing the NR Recorder
2. Install the battery:
Open the battery compartment cover by moving left and up
the cover latch.
Insert a fresh AA battery. First insert from the negative
terminal. Ensure that the battery’s removal ribbon goes
behind the battery.
Close battery compartment cover and press on it until latches
into the base part. Make sure that the ribbon is completely
hidden under the cover.
3. Press the button
on the NR Recorder to turn it ON.
1.
Attach the Patient Cable
:
Insert the ECG cable connector into the slot on top of the
NR-1207-3 unit. Make sure to insert the cable connector
until both of two latches of the cable connector are locked
on the unit.

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4. Configure the R Recorder for ECG mode:
Press the button to enter the Settings screen.
Navigate with the button down to the System Settings
and then press the button to open the system settings
Navigate with the button down to the Mode setting and
then press the button to open the device mode options
Navigate with the button down to the ECG mode and then
press the button to open the Bluetooth Pairing options.
Press the button to return to the Settings screen, then
select the Save as Default and press the button to
save the changes.

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5. Configure the Bluetooth settings in the R Recorder:
Open the the System Settings screen, select and then open the
Bluetooth setting.
Press the button to open the Bluetooth Pairing options.
Navigate with the button down to the Passcode option
then press the button to apply the selection.
Press the button to return to the Settings screen.
Select the Save as Default option the Bluetooth setting then press
the button to save the changes.

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Pairing the R Recorder with iOS Mobile Device
The pairing procedure establishes a connection between the iOS mobile device and the NR Recorder.
1.
OTE
OTE: This pairing procedure is only necessary for initial setup of a mobile
device and E G acquisition module.
1. On R Recorder:
select the Pairing command on the Settings screen then press
the button to start pairing
NR Recorder will show the Waiting for Passcode screen
2.
On iOS mobile device:
open Settings
select Bluetooth
make sure it’s turned ON
select the R Recorder name
in the found Bluetooth accessory list
tap Pair on the Bluetooth Pairing Request message

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First Time the orav Mobile ECG App Settings
1. Tap the orav Mobile ECG shortcut. When the App screen will appear—open Settings.
2. Enter the Physician and Clinic information then exit to App main screen by tap the X icon
3. On R Recorder:
validate the pairing code is same as on the iOS device then
press the button to confirm the pairing
4. On iOS mobile device:
Make sure that the NR Recorder is Connected

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Performing the ECG test
This chapter reviews the tasks associated with running a test
■ Hook up the Patient
Connect the LIMB leads:
Connect the CHEST leads
NOTE
NOTE: Make sure the NR Recorder is turned ON
■ Entering Patient Information
Tap Start ew Test
Enter Patient Details then tap Start
RA
V
4
V
5
V6
V1
V2
V3

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■ Recording the ECG
If Select An Accessory message appears
tap the NR Recorder name.
The iOS device will start running the ECG
traces
Wait about 10 secs you will see the Stop
button flashes (means it’s ready to save).
Tap Stop button to save the test and to enter
Report Mode.

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Saving Test Results and Generating Report
Tests Archive
Report View controls:
To add/edit remarks tap the Edit Remark button
Share report to EMAIL
Upload report to FTP server and to Norav cloud
Get Automated Measurement & Diagnostics
(after uploading the report to Norav cloud)
Enter other measurements such as Blood
Pressure, SpO2, Body Temperature and
Glocose
Back to the main screen
Record new ECG for same patient
Return back to the app main screen
Tap the Test Archive on the app main screen
Here you will see all the tests you have made
ordered by last date.
To access the test report—tap the selected
patient row.
To search patient by ID or by Name enter the
looking value in the Search input field

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Enhanced Features
Parameter
Optional Values
Description
Horizontal Scale
12.5,
25,
50,
100
Set Real Time ECG Graph horizontal progress rate
in mm/sec
Vertical Scale
5,
10,
20,
40
Set Real Time ECG Graph vertical height in mm/mV
Report Types
To select report type:
1. Open Settings
2. Select Report Type
3. Choose needed report format
3x4 report type is successive and show all leads
from 1-5 sec except lead strip from 1-10 sec
2x6 report type is successive and show all leads
from 1-5 sec except lead strip from 1-10 sec
12 Leads report showing all 1-10 sec.
1x6 report showing 1-10 sec of limb leads
(I, II, III, aVR, aVL, aVF).

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Recording Type The app is supporting long recording option. Long
recording means that when you start new test it will
save right from the start (not just the last 10 sec) and
it will stop when the user will stop it.
To activate long recording:
1. Open Settings
2. Select Recording Type
3. Choose Rhythm Recording 24HR
Constant Email
Recipients
Set Constant Email Recipient when sending test
results via email.
To add new email recipient/s:
1. Open Settings
2. Select Email To
3. Enter recipients
* You can add multiple recipient using the ; sign
separator
Life Measurements
Support + Email
life measurement can be added in
manually by clicking manual
measurement button
BP
= Blood Pressure (Systolic/Diastolic)
Spo2 = oxygen saturation measured in %
Temp = Body Temperature (Celsius).
GLU = Glucose (Blood sugar) level ( mg/dl ).
Multiple Date F
ormat
Support
Adding support for multiple date formats:
1. mm-dd-yyyy [month – day – year]
2. dd-mm-yyyy [day – month – year]
3. yyyy-mm-dd [year – month – day]
To change date format:
1. Open Settings
2. Click Date Format
3. Choose the needed format
Ready template ECG
editable remarks In order to save time to the technician or the doctor,
we’ve added ready remarks template (for ECG). The
remarks are editable and managed.

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1. Open report preview screen.
2. Click remarks on the button:
3. Click on ‘Add template remark’ button.
4. Select remark from the list, for example
‘normal’
5. You will see the select remark inside the
textbox.
6. Click OK.
Manageable Remarks The user can also manage the remarks in the
settings screen.
1. In Settings screen, select ‘Edit ECG
remarks.’
2. Remarks Editor Screen will open
3. To Edit the existing remark:
a. Select the remark you want to edit (it will
be gray)
b. Click on Edit button
c. Enter The new Remark
d. Click OK button
4. To Delete the existing remarks:
a. Select the remark you want to edit (it will
be gray)
b. Click on delete button
5. To Add new remark:
a. Click on Add button
b. Enter The new Remark
c. Click OK button
Simulator Mode Simulator mode gives you the ability to run the App
with simulated Hardware which connected to human
body. This operation runs ECG waves in real time, so
you can complete the full process for testing and
playing with this App.
*Simulator mode will be labeled as Hazards in: ECG
leads, summary report and database.