J-TECH Northstar Echo User manual

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objective functional
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© 2018 JTECH Medical MN065_N
INTAKE EVALUATE ANALYZE REPORT

NORTHSTAR ECHO USER’S MANUAL
© 2018 JTECH Medical MN065_N
Northstar Echo Manual
Publicaon Informaon
© 2018 JTECH Medical All rights reserved. This manual is provided as a service to our customers, any other use
is strictly prohibited. This manual may not be reproduced by any means, physically or electronically, without
the express wrien consent of JTECH Medical.
Northstar Echo and JTECH Medical Northstar are trademarks of JTECH Medical Industries, Inc. Microso
and Windows are trademarks or registered trademarks of Microso Corporaon. VELCRO® is a registered
trademark of Velcro Industries B.V. CaviWipes is a registered trademark of Metrex Research.
JTECH Medical Industries, Inc.
7633 S Main
Midvale, UT 84047
United States of America
[phone]
[phone]
Fax [phone]
www.jtechmedical.com
Advena Ltd.
Tower Business Centre, 2nd Floor,
Tower Street, Swatar,
BKR 4013 Malta
0086

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© 2018 JTECH Medical MN065_N
INTAKE EVALUATE ANALYZE REPORT
C ontents
Graphic Symbol Denions ....................... 2
Convenons Used Throughout This Manual ......... 3
LED States ..................................... 4
Receiver LED states . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Device LED states............................. 4
Warnings and Nocaons ....................... 5
Waste Disposal ............................... 5
EMC Noce .................................. 6
Wireless informaon........................... 6
Declaraon of Conformity ...................... 6
Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Indicaons/Contraindicaons for Use ............ 7
System Setup................................... 7
Inial Baery Charge.......................... 7
Charging Device Baeries ...................... 7
Baery Life.................................. 7
Displaying Device Baery Voltage ............... 7
Device Operaon ............................... 8
Features and Benets . . . . . . . . . . . . . . . . . . . . . . . . . 8
Available Upgrades ........................... 8
Wireless Receiver (9RF401) ....................... 8
Wireless Dual Inclinometers (9RF403, 9RF404) . . . . . . . 9
Wireless Muscle Tester (9RF405).................. 10
Wireless Grip (9RF406) .......................... 11
Wireless Algometer (9RF407) .................... 12
Wireless Goniometer (9RF408) ................... 13
Wireless Pinch Gauge (9RF409) ................... 14
Wireless Stac Force Gauge (9RF410).............. 15
Frequently Asked Quesons ..................... 17
Troubleshoong Your Devices .................... 18
Storage and Cleaning of Devices .................. 19
Storage .................................... 19
Cleaning, Disinfecon, and Sterilizaon .......... 19
Maintenance .................................. 20
Product Registraon............................ 20
Repair Policy .................................. 20
Customer Support ............................. 21
Support Policies.............................. 21
Hardware ................................. 21
Northstar Soware ......................... 21
Before Calling for Support ..................... 21
Product Return Policy ......................... 22
Hardware Limited Warranty ..................... 23
Technical Specicaons
for Wireless Receiver (9RF401) ................... 24
Technical Specicaons
for Wireless Dual Inclinometers (9RF403, 9RF404) ... 25
Technical Specicaons
for Wireless Muscle Tester (9RF405)............... 26
Technical Specicaons
for Wireless Grip (9RF406)....................... 27
Technical Specicaons
for Wireless Algometer (9RF407) ................. 28
Technical Specicaons
for Wireless Algometer End Test Switch (RF116) . . . . . 29
Technical Specicaons
for Wireless Goniometer (9RF408) ................ 30
Technical Specicaons
for Wireless Pinch Gauge (9RF409) ................ 31
Technical Specicaons
for Wireless Stac Force Gauge (9RF410) ........... 32
Technical Specicaons and Warnings for Stac Force
Gauge Accessories ............................. 33
Technical Specicaons for Power Supply (PW006) .. 35
Technical Specicaons for Power Supply (PW008) .. 36
EMC Guidance................................. 37

NORTHSTAR ECHO USER’S MANUAL
© 2018 JTECH Medical MN065_N
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Graphic Symbol Denions
Symbol Meaning
An ISO 7010-M002 symbol Consult Instrucons
An ISO 15223 symbol Keep Dry, do not immerse in water or other liquids
Informaon symbol
I P X N
An IEC 60529 symbol IPXN, N=0 no protecon against ingress of water.
N=1 protecon against vercally falling water drops
An ISO 7000-0434A symbol Cauon
An IEC 60417-5840 symbol Indicates type of protecon against electric shock:
Type B applied part
An IEC 60417-5140 symbol Non-Ionizing Radiaon
An ISO 15223 symbol Warning: devices are non sterile
FCC Logo Northstar Echo products comply with Part 15 of the FCC Rules
An IEC 60878 symbol Indicang Degree of protecon against electric shock:
Class 2 Electrical equipment
An ISO 15223 symbol Indicang upper and lower temperature limits
An ISO 15223 symbol Indicang upper and lower humidity limits
An ISO 15223 symbol Indicang upper and lower atmospheric pressure limits
0086
“Conformité Européenne”
(“European Conformity”)
Northstar Echo products meet the provisions of the Council Direcve
93/42/EEC
An EN 980 symbol Idenfying the Manufacturer
An EN 980 symbol Idenfying the Authorized Representave for European Communies
An IEC 60878 symbol Signifying Alternang Current
An IEC 60878 symbol Signifying Direct Current

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INTAKE EVALUATE ANALYZE REPORT
Convenons Used Throughout This Manual
The following convenons are used in the manual to describe the devices, and operaon:
• Calibraon - The process of using a known force or angle to adjust the device parameters so that any
arbitrary force or angle input can be accurately determined.
• CV - The coecient of variaon (CV) is dened as the rao of the standard deviaon (σ) to the mean (μ), or
in mathemacal terms, CV = σ / μ. In probability theory and stascs, CV serves as a normalized measure
of variability to help describe the relave scaer or spread of a data sample. A smaller CV suggests a higher
level of consistency. A calculated CV less than 15% (0.15) is oen used as an indicator of consistent eort by
subjects during biometric strength tests.
The Northstar soware calculates CV using populaon standard deviaon. Note that this diers from CV
calculated using the sample standard deviaon, which can give a very dierent result.
• Device - This refers to a JTECH Medical tesng device, used in conjuncon with the Northstar soware to
record test data.
• Exam - This term is used to refer to a group of tests performed with the same device.
• Repeon, or Rep - A single instance of measuring performance for a designated device.
• RF - Radio Frequency.
• ROM - Range of Moon.
• Side - Either le or right, noted as L and R, respecvely.
• Test - Used to refer to a group of repeons performed for one or more sides with a given device.
• Threshold - The minimum force or angle that must be exceeded to start or end a repeon. This is also the
minimum force or angle that can be reached before the repeon ends.
• Zero or Zero Calibraon or Set Zero - The process of determining the device parameters when no force or
angle is applied to the device.

NORTHSTAR ECHO USER’S MANUAL
© 2018 JTECH Medical MN065_N
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Receiver LED states Explanaon
O O, the Receiver is not powered
On The Receiver is powered.
Device LED states Explanaon
O O power state.
Solid GREEN
Device is indicang that the baery has completed charging.
Solid GREEN, blinking BLUE 1
me per second,

The device is plugged in, receiving power from an external source, and
the baery is acvely charging.
Alternang BLUE / GREEN
The baery is overheated (thermal fault) warning.
Solid ORANGE
Unknown baery status.
Blinking RED 10 mes per second

The device has a low baery and is awaing for a communicaon link
with the Receiver.
Solid RED
Baery is crically low (Less than 20 minutes remaining).
Blinking RED 5 mes per second
     Baery is dead. This happens on any aempt to turn the device on.
Blinking RED 1 me per second

The device has a low baery and acvely communicang with the
Receiver.
Solid RED blinking OFF 1 me per
second
The device has a low baery and is aempng to reestablish
communicaon with Receiver.
Blinking BLUE 1 me per second

The device is in tesng mode and acvely communicang with the
Receiver.
Solid BLUE blinking OFF 1 me
per second Waing to reestablish communicaon with the Receiver.
Blinking BLUE 10 mes per
second

The device is waing for a communicaon link with the Receiver.
LED States

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INTAKE EVALUATE ANALYZE REPORT
Warnings and Nocaons
Protecon against ingress of liquids: Not protected against ingress of liquids. Keep Dry, do not immerse in
water or autoclave any poron of Northstar Echo receiver, devices, or accessories.
Type of protecon against electric shock: Type B applied part.
Devices emit non-ionizing radiaon.
Warning: Devices are not sterile.
Warning: Northstar Echo devices should only be used by trained professionals.
Warning: No modicaon of equipment is allowed. Do not open the receiver, device, transceiver or receiver
housings. Opening of housings by anyone other than an authorized JTECH service representave will void your
warranty.
Warning: Changes, or modicaons, not expressly approved by JTECH Medical could void the user’s authority
to operate the equipment.
Warning: Use only a factory-supplied, medical-grade power supply cered to charge medical devices.
Use of another charger may result in electrical shock or equipment damage. It is not recommended that
you charge the devices by connecng them to a computer.
Warning: Northstar Echo devices are not intended for use while aached to the charger. Never aempt to
operate the device while it is connected to the charger as electrical shock or damage to the device may occur.
Warning: Northstar Echo devices have no user serviceable parts.
Warning: This device is not suitable for use in the presence of ammable anesthec mixture with air, or with
oxygen or nitrous oxide.
Warning: Follow all direcons as specied by the CaviWipe product being used. Allow devices to dry before
use.

Noce: Northstar Echo devices are precision medical devices and should be treated with care. Avoid dropping,
banging, or other impacts to the devices.

Noce: Use only within designated operang parameters, i.e. temperature and humidity limits.
Warning: Disconnue use of any product if skin irritaon develops.
Waste Disposal
Warning: Northstar Echo devices contain Lithium Polymer baeries. Do not dispose of any Northstar Echo
device in re.
Disposal Instrucons: Northstar Echo Devices are not known to contain any hazardous materials. Consult your
local waste management facility on proper disposal of solid waste. Recycling should be used where available.

NORTHSTAR ECHO USER’S MANUAL
© 2018 JTECH Medical MN065_N
6
EMC Noce
The Northstar Echo wireless system includes a variety of devices containing a built-in radio frequency transceiver that transmits to,
and receives data from, the Northstar Echo receiver. For more informaon on EMC see appendix “EMC Guidance” on page 37.
WARNING: Medical Electrical Equipment needs special precauons regarding EMC and needs to be
installed and put into service according to the EMC informaon provided in this manual. Carefully read
the informaon contained in this secon.
WARNING: The use of portable and mobile RF equipment can aect the normal operaon of medical
electrical equipment.
WARNING: Making any modicaons or using any accessories not specically approved by JTECH
Medical may reduce immunity to electromagnec interference or increase electromagnec emissions.
WARNING: The Northstar Echo devices and receiver should not be used while stacked on, or adjacent
to, other electrical or medical electrical equipment. If stacked or adjacent use is necessary, all electrical
equipment should be observed to verify normal operaon.
Wireless informaon
The Northstar Echo devices and receiver transmit in a 2.4GHz wireless frequency.
Contains FCC ID: OUR-XBEE
Contains Model XBee-Radio, Canada IC: 4214A-XBEE
Japan ID: 005NYCA0378
This device complies with Part 15 of the FCC Rules. Operaon is subject to the following two condions:
(i) this device may not cause harmful interference and (ii) this device must accept any interference
received, including interference that may cause undesired operaon.
Declaraon of Conformity
These devices are:
Class I measuring medical devices per Annex IX of Council Direcve 93/42/EEC
Class I medical devices per CFR Title 21 Part 888 Subpart B
Class II medical devices per Schedule 1, Part 1 of SOR/98-282 of the Canadian Medical Devices Regulaons
These devices also meet the following Technical Standards, to which Conformity is declared:
IEC 60601-1
IEC 60601-1-2
These devices are designed and manufactured in a facility cered to the following internaonal standards:
ISO 13485 with Canadian Medical Devices Conformity Assessment System (CMDCAS)
Intended Use
The intended use of the Northstar Echo product line is to assist the clinician with establishing an objecve
assessment of a person’s physical strength, range of movement, and (with the Algometer) establishing pain
tolerance levels. The devices are intended to be used as non-invasive, non-surgical and transient devices. The
devices are indicated for use when objecve assessment of strength, range of moon, or pain tolerance is required.

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© 2018 JTECH Medical MN065_N
INTAKE EVALUATE ANALYZE REPORT
Indicaons/Contraindicaons for Use
The devices are indicated for use when objecve assessment of strength, range of moon, or pain tolerance is
required. The devices should not be used in the following circumstances: on or near the eyes, on or near fractures,
on or near open wounds, on or near burned ssue, with paents suering with severe osteoporosis, and for any
purpose other than indicated.
System Setup
Initial Battery Charge
Performing the required inial charge for your new device baeries is essenal before aempng to use them.
When not in use, Northstar Echo devices remain in a “power-o” state to conserve baery life. If not used, the
device can remain in the o-power state for several days without needing a recharge. However, if the device
has not been charged within 30 days, we recommend recharging the baery before use.
Warning: Northstar Echo devices should not be used for tesng while connected to the charger.
Warning: Use only a factory-supplied, medical-grade power supply cered to charge medical
devices. Use of another charger may result in electrical shock or equipment damage. It is not
recommended that you charge the devices by connecng them to a computer.
Noce: Device baeries should be fully charged before aempng to use them with your Northstar
Echo System. Each device must charge for at least four (4) connuous hours before its rst use.
Noce: Be careful not to drop devices while connected to the charger as it may cause damage to the
device.
Charging Device Batteries
1. Plug the baery charger daisy chain plug into the device charging jack. You can charge up to four
devices at a me. Place the device on a at surface or back in the case while it charges.
2. Plug the baery charger into a properly rated wall outlet. Baeries should be charged for four (4)
connuous hours each me you charge.
3. Once a device is charged, disconnect it from the baery charger.
4. Charge all devices with your system before establishing communicaons with your computer.
Battery Life
The Northstar Echo devices have rechargeable Lithium Polymer baeries. The devices are able to operate for
approximately eight (8) hours of connual use. In order to conserve baery life, the devices have an automac
shut-o, which will trigger aer 10 seconds of inacvity.
Displaying Device Battery Voltage
Follow the steps in the Northstar soware manual.

NORTHSTAR ECHO USER’S MANUAL
© 2018 JTECH Medical MN065_N
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Device Operaon
Aer inial charging is complete, we recommend you contact JTECH Medical to complete the soware
installaon and setup. Please consult your Soware User Guide for specic soware related setup
instrucons.
Features and Benefits
• The Northstar Echo system is a baery powered wireless tesng system, which allows for exibility and
mobility in tesng.
• Hands Free Wireless Tesng - no tethers or cables to interfere with tesng or clinic set up.
• Impact resistant PVC plasc housings.
• Ergonomic designs.
• Designed for tesng criteria for published research.
• Built-in long-life rechargeable Lithium Polymer baeries mean there is no need to replace baeries.
• Addional device specic Features and Benets can be found under the device specic secons.
Available Upgrades
In addion to adding devices, the following upgrade products are available:
Northstar Soware modules - For more informaon on upgrades, contact your JTECH Medical sales
representave or call JTECH Medical at [phone] or [phone].
Detachable Parts
USB Extension Cable (7WR001) – The USB Extension Cable is used to connect the USB
Receiver to a USB port on your computer.
For instrucons on operang the Northstar soware, please refer to the
Northstar soware manual.
Northstar Soware
Wireless Receiver (9RF401)
Used to send and receive wireless transmissions to/from Northstar
Echo devices.
Instrucons for using wireless receiver:
1. Connect the Wireless Receiver to the USB Extension Cable.
2. Connect the USB Extension Cable to an open USB port on your
computer.
For troubleshoong informaon, please see page 18.
For technical specicaons, please see page 24.