Abbott Merlin@home EX1100 User manual
Merlin@home™
Transmier
Model EX1100
User's Manual
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
™ Indicates a trademark of the Abbo group of companies.
‡ Indicates a third-party trademark, which is property of its respecve owner.
Pat. hp://www.abbo.com/patents
© 2022 Abbo. All Rights Reserved.
Contents
Introducon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
What Does the Merlin@home™ Transmier Do?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Using your Merlin@home™ Transmier with a Cellular Adapter. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Using your Merlin@home™ Transmier with a Wireless Broadband Kit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Using your Merlin@home™ Transmier with your Landline. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Can You Use the Transmier While Traveling?. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Important Safeguards. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Security Consideraons. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Seng Up the Transmier. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Merlin@home™ Session. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Device Check. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Shut Down. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Transmier Reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Transmier Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Soware Updates and Your Transmier. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Caring for the Transmier. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
MerlinOnDemand™ Capability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Glossary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Technical Support. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Supported Devices. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Reboong Your Transmier. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Technical Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Transmier Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Electromagnec Compability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Inducve Telemetry Wand. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Wireless Communicaon Troubleshoong. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
FCC Informaon. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
i
ii
Introducon
Your doctor has given you the Merlin@home™ transmier that is part of the Abbo Medical
Merlin@home Remote Monitoring System. This manual describes this system and explains how to set up
and use the transmier.
What Does the Merlin@home™ Transmier Do?
The Merlin@home™ transmier conducts your Merlin@home session. During your Merlin@home session,
the transmier reads the informaon from your implanted device and sends it to a server where your clinic
can view it. This informaon includes:
▪The type and serial number of your device
▪
▪The sengs for your device
▪
▪What has happened since your last follow-up session
▪
▪Baery status of your device▪
Your transmier can perform a status check on your device.
Your device connues to work normally while the transmier reads the informaon. Your doctor can use
this informaon to help check the status of your device.
Your Merlin@home transmier works with the following:
▪landline telephone (landline)
▪
▪cellular adapter▪
▪wireless broadband kit
▪
NOTE:
▪Only your clinic, and Technical Support (page 6) if requested by your doctor, can view the
▪
condenal informaon you send during your Merlin@home session.
▪Normal use of the transmier has lile impact on the baery usage of your device. Conduct your
▪
sessions according to the schedule provided by your clinic.
The Merlin@home Transmier is contraindicated for use with any implanted medical device other than
supported St. Jude Medical and Abbo medical implanted devices.
The intended users of the Merlin@home transmier include the following:
▪Clinician, which includes implanng physician, managing cardiologist or electrophysiologist, and allied
▪
health professionals
▪Paent and caregiver▪
▪Abbo Medical eld sta such as technical service specialists, eld clinical engineers, and sales
▪
representaves
Using your Merlin@home™ Transmier with a Cellular Adapter
The Merlin@home™ transmier model EX1100 can be used with the cellular adapter provided with your
transmier. For more informaon, see the Merlin@home Start Up Guide.
Using your Merlin@home™ Transmier with a Wireless Broadband Kit
The Merlin@home™ transmier model EX1100 can be used with a wireless broadband kit. For more
informaon, see the Merlin@home Start Up Guide.
Using your Merlin@home™ Transmier with your Landline
The following informaon is applicable if you are using a landline to connect the transmier. If you are using
the cellular or wireless broadband adapters to connect the transmier, a landline is not needed.
1
The Merlin@home™ transmier plugs into your landline, see Seng Up the Transmier (page 4), and
uses the telephone network to send informaon to the server, where your clinic can view the informaon.
As far as your landline is concerned, this is like any other call to a toll-free number within the United States
and Canada.
Before your Merlin@home session starts, you must hang up all phones. If someone calls during your
session, you receive a Can't Send Informaon message. For more informaon, see the Merlin@home Start
Up Guide.
When the transmier is not reading or sending informaon, it is idle. Leaving the transmier connected to
your landline does not aect your landline's normal operaon. You can sll make and receive calls.
NOTE: At any me during your Merlin@home session, you can interrupt your session to use the landline. If
you do not hear a dial tone when you pick up your landline handset, hang up and pick up your handset
again. If your Merlin@home session is interrupted, the transmier may display a Can't Send Informaon
message. If so, press the Start buon and the transmier will aempt to send your informaon at a later
me.
To use the Merlin@home™ transmier, your landline service provider must support touch-tone dialing. You
must use a push-buon telephone with a standard landline plug (RJ-11). Your wall phone jack must also
accept a standard plug. If you have an older plug or jack, you can purchase an RJ-11 adapter that allows you
to use the transmier.
NOTES:
▪If your landline is wired into the wall, you cannot use the transmier unless you install standard wall
▪
phone jacks. To do this, contact the telephone company for help.
▪If DSL shares your telephone line, contact your DSL service provider for a lter to prevent any possible
▪
interference. Plug the lter into the wall phone jack and plug the phone connector into the lter. For
more informaon on how to use the lter, contact your DSL service provider.
CAUTION: The transmier is designed for use with direct analog landlines. It may be damaged by any
other type of phone line. See Technical Support (page 6).
Can You Use the Transmier While Traveling?
The Merlin@home™ transmier works within your country, but it might not work outside your country. The
typical recommendaon is to take your transmier only if you are going to be away from home for a long
periods of me. Check with your doctor before traveling with the transmier.
If your doctor recommends not traveling with the transmier, leave your transmier plugged in at home
and it will read your device informaon when you return home.
If your doctor agrees that it is all right, carefully repackage the transmier in its original packaging.
▪If you are using a landline with your Merlin@home transmier, you may want to purchase a standard▪
plug adapter in case you need to plug the transmier into an older wall phone jack.
▪If you are using a connecvity accessory such as a cellular adapter, ensure that you bring your cellular▪
adapter with you.
Important Safeguards
Always follow basic safety precauons when using electrical products, especially when children are present.
These include:
▪Read all instrucons before using.▪
▪Keep these instrucons.▪
WARNING: For emergencies, call 911
▪Do not spill any liquid on the transmier. If you spill any liquid, unplug the transmier and wipe the▪
liquid o right away. Do not plug the transmier in unl it is completely dry.
To reduce the risk of shock:
▪Do not use the transmier while bathing.
▪
▪Do not place or store the transmier where it can fall or be pulled into a tub or sink.
▪
▪Do not place or drop the transmier into water or other liquid
▪
2
▪
▪Do not reach for a transmier that has fallen into water. Unplug it immediately.▪
To reduce the risk of burns, shock, re, or injury to persons:
▪Supervision is necessary when the transmier is used by, on, or near children.
▪
▪Use the transmier only for its intended use as described in this manual. Only use aachments
▪
recommended by Abbo Medical.
▪Never operate the transmier if it is not working properly, if it has been dropped or damaged, or if it
▪
has been dropped into water. Contact Technical Support (page 6) for service or replacement
instrucons.
▪Keep the cord away from heated surfaces.
▪
▪Do not operate the transmier on heated surfaces.▪
▪Do not use outdoors or operate where aerosol (spray) products are being used. Do not operate in an
▪
oxygen-rich environment (for example, in an oxygen tent or oxygen chamber).
▪Do not use the transmier near ammable substances.
▪
Security Consideraons
Merlin@home™ is a monitoring device and does not aect the crical funconality of an implantable
medical device (IMD) even in the case of a cybersecurity compromise. In the unlikely event of a
cybersecurity breach, please contact your clinician
Merlin@home is congured to have appropriate cybersecurity controls by default. There are no manual
conguraons required for secure network setup.
There are no infrastructure requirements, except for the presence of an internet connecon for Wi-Fi
access point or RJ-11 port for dial up connecons.
Merlin@home uses a hardened Linux-based operang system with a rewall and intrusion detecon system
(AIDE).
Merlin@home does not allow any incoming connecons, unless iniated by itself. Only the DHCP client is
expected to receive the DHCP responses for establishing a network connecon. All other network ports are
closed.
Merlin@home automacally downloads the soware updates, whenever a newer version is available. The
soware updates are encrypted and cryptographically veried before installaon.
Merlin@home collects session logs, interface event logs, soware update logs, and AIDE logs. These logs are
sent to Merlin.net™ Paent Care Network regularly.
A Cybersecurity Bill of Materials (CBOM) is available upon request).
Merlin@home automacally downloads available soware updates.
Figure 1. System diagram
1. Paent1.
2. Sensing therapeuc signals2.
3. Implantable medical device (IMD)3.
4. Diagnosc informaon sent over secure channel4.
5. Merlin@home5.
7. Merlin.net
7.
8. Conguraon/diagnosc informaon sent over8. secure channel
9. Programmer9.
10. Conguraons/ diagnosc data10.
3
6. Encrypted Paent Diagnosc data sent over6. secure channel (using dial-up or cellular network
or Wi-Fi network)
11. Clinician11.
12. Diagnosc data12.
Seng Up the Transmier
For instrucons on how to set up the transmier, see the Merlin@home Start Up Guide.
▪Place the transmier on a sturdy, at, hard surface. The transmier must be at on the surface at all▪
mes.
▪The Merlin@home transmier is not magnec and has no moving parts. However, you should avoid
▪
devices which generate a strong electric or magnec interference (EMI). EMI could interfere with the
performance of the transmier. Moving the source of EMI away from the transmier or turning the
source of EMI o will usually allow the transmier to return to its normal mode of operaon. Sources of
EMI may include communicaon equipment, wireless communicaon devices, household appliances,
and industrial equipment.
▪Do not press the Reset buon on the back of the transmier unless requested to do so by Technical
▪
Support (page 6).
▪Use only Abbo Medical supplied accessories in the USB port. Addional equipment connected to
▪
medical electrical equipment must comply with the respecve IEC or ISO standards (e.g. IEC 60950 for
data processing equipment). Furthermore all conguraons shall comply with the requirements for
medical electrical systems (see clause 16 of the 3.1Ed. of IEC 60601-1). Anybody connecng addional
equipment to medical electrical equipment congures a medical system and is therefore responsible
that the system complies with the requirements for medical electrical systems. Aenon is drawn to the
fact that local laws take priority over the above menoned requirements. If in doubt, consult your local
representave or the technical service department.
▪Somemes issues with your phone, cellular adapter, or internet service provider may prevent your
▪
transmier from sending your informaon. Contact Technical Support (page 6) or your clinic. Keep
the original shipping box in case you need to return the transmier for service.
▪The transmier is congured for either single paent or mulple paent use. For mulple paent use,
▪
the transmier retrieves full follow up data. or retrieves data for display only in the Heart Failure
Management applicaon on the Merlin.net™ PCN.
▪Leave your transmier plugged into the wall electrical outlet, unless otherwise indicated by your clinic.
▪
Merlin@home™ Session
Conduct a Merlin@home™ session according to the schedule set by your clinic. For instrucons on how to
set up and use the transmier, see the Merlin@home Start Up Guide.
Device Check
Conduct a device check only if your clinician instructs you to do so. To conduct a device check:
1. Place the wand, colored side towards you, over your device.
1.
Do one of the following:
– If only the green light is lit, go to Step 2.–
– If the “Stars” icon is lit, go to Step 3.–
2. Press the Start buon. The “Stars” icon lights up.2.
3. Press the Start buon for 3 to 4 seconds unl you hear two beeps.
3.
The “Read” icon ashes when the transmier searches for your device. It will stop ashing but remains
lit while the transmier reads the device and the progress lights will move le to right.
4. The “Tower” icon lights up when the transmier has read your device. You can remove your wand.4.
5. The “Stars” icon lights up when your device check is complete. The “Stars” icon will turn o aer a short
5.
me.
4
–
–
Shut Down
To power down the Merlin@home™ transmier, unplug the power supply from the wall electrical outlet. If
using a landline, you may leave the phone cord from the transmier plugged into the wall or disconnect it. It
should not aect your landline.
Transmier Reset
Reset your transmier only if Technical Support (page 6) instructs you to do so.
Transmier Messages
Errors may result from variaons in landline equipment, informaon transmission me, or the quality of the
landline connecon. If the transmier is plugged in and the green power light does not come on. contact
Technical Support (page 6). For more informaon on transmier errors and messages and how to
respond to them, see the Merlin@home™ Start Up Guide.
NOTE: Occasionally the soware in your Merlin@home transmier is automacally updated. If any acon is
required on your part, you will be noed.
Soware Updates and Your Transmier
It is important to keep your transmier powered on and the connecvity accessory plugged in so that the
transmier can receive occasional automac soware updates. If transmier connecvity is not
maintained, your transmier’s soware may not be updated to the current version and your transmier
may no longer be able to transmit or receive informaon.
Caring for the Transmier
If necessary, you can clean the outside of the Merlin@home™ transmier with a cloth dampened with
water. Do not clean the transmier while a session is in progress. The transmier is classied as IPX0
because it is not waterproof. Do not immerse the transmier in any liquid.
If there is a problem with the transmier, contact Technical Support (page 6) for a replacement.
WARNING: The transmier does not contain any user-serviceable parts. This product complies with
medical product regulatory standards. In order to maintain that compliance, do not open the case.
MerlinOnDemand™ Capability
MerlinOnDemand™ (MoD) is an EX1100 transmier capability where the transmier can receive
informaon from a device in unpaired mode. With MoD capability, the transmier will retrieve full follow-
up data or retrieve data for display only in the Heart Failure Management applicaon on the Merlin.net™
Paent Care Network (PCN).
The MoD capability enables clinicians to do the following:
▪support remote care paents in emergency rooms and heart failure clinics
▪
▪triage paents for in-clinic follow-ups▪
▪support paents in a clinical seng with Merlin.net PCN▪
For more informaon on seng up the MerlinOnDemand EX1100 transmier, sending implant informaon,
and troubleshoong, please see the MerlinOnDemand™ capability with Transmier Model EX1100 Start Up
Guide.
Glossary
Clinic — The place that views your informaon aer the Merlin@home™ transmier sends your
informaon to the server.
Informaon — The informaon stored in your device. The informaon includes your device type and serial
number, sengs, and baery status.
Device — Your implanted device, also known as an ICD (implantable cardioverter-debrillator), CRT-D
(cardiac resynchronizaon therapy debrillator), pacemaker, or CRT-P (cardiac resynchronizaon therapy
pacemaker).
5
Merlin@home session — A remote monitoring session in which your informaon is sent to the server,
where the clinic can view your informaon.
Server — The place where your informaon from the Merlin@home session is sent.
Transmier — The part of the Merlin@home Remote Monitoring System that reads the informaon in your
device and sends it to the server.
Technical Support
For Merlin@home™ transmier issues:
Monday through Friday (8AM to 8PM Eastern Standard Time)
▪1 877 696 3754 (1 877 MY MERLIN) (toll-free within North America)
▪
▪1 818 493 4258
▪
Monday through Friday (8AM to 5PM Central European Time)
▪46 8 474 4756 (Sweden) (Support in English and Swedish. For addional assistance, contact your clinic.)▪
Supported Devices
The devices listed in the tables below are supported by transmier model EX1100 with MerlinOnDemand™
capability.
NOTES:
▪This informaon is for clinicians and is applicable only to MerlinOnDemand capability.
▪
▪Some devices may not be available in your region.
▪
If you aempt to interrogate a device not listed here, the transmier will not idenfy the device.
The Abbo Medical device families that the MerlinOnDemand EX1100 transmier supports are:
▪Accent™ pacemakers▪
▪Allure™, Allure™ RF, Allure Quadra™, Allure Quadra™ RF cardiac resynchronizaon therapy pacemakers
▪
(CRT-Ps)
▪Anthem™ pacemakers and Anthem™ RF CRT-Ps▪
▪Assurity™, Assurity™+, Assurity™ RF, Assurity MRI™ pacemakers▪
▪Avant™ ICDs and CRT-Ds
▪
▪Convert™ ICDs
▪
▪Current™, Current™+, Current Accel™ ICDs
▪
▪Ellipse™ ICDs▪
▪Endurity™, Endurity™ Core, Endurity MRI™ pacemakers▪
▪Entrant™ ICDs and CRT-Ds▪
▪Forfy™, Forfy Assura™ ICDs▪
▪Gallant™ ICDs and CRT-Ds▪
▪Neutrino™ NxT ICDs and CRT-Ds▪
▪Promote™, Promote™+, Promote Quadra™, Promote Accel™ CRT-Ds▪
▪Quadra Allure™, Quadra Allure™ RF, Quadra Allure™ MP CRT-Ps▪
▪Quadra Assura™, Quadra Assura MP™ CRT-Ds▪
▪Unify™, Unify Assura™, Unify Quadra™ CRT-Ds
▪
For descripons of specic Abbo Medical devices, warnings, cauons, and implantaon instrucons, refer
to the user's manual for the applicable device.
Reboong Your Transmier
If your transmier cannot send informaon, it may have an unsecured connecon and you may need to
reboot your transmier.
6
1. Secure the connecon.1.
Secure either the USB port to the adapter or the
phone cord from your landline phone to the
phone jack.
or
2. Press and release the black reset buon on the2.
back of your transmier.
3. The progress lights on the transmier will blink 13.
to 2 minutes, but no icons will be lit.
Reboong can take a while. Aer the reboot is complete, the transmier aempts to send the informaon
again.
Symbols
The symbols below and harmonized symbols may be found on the product or product label. For harmonized
symbols, refer to the Universal Symbols Glossary at hps://medical.abbo/manuals.
Symbol Descripon
Transmier
Model EX1100 Merlin@home transmier
Phone cord and splier (phone connector)
Merlin@home inducve wand
7
Symbol Descripon
Product literature
Follow instrucons for use on this website
USB wireless adapter
USB wireless adapter's clip and USB cable
Wireless access point
Wireless access point's ethernet cable
Wireless access point's power supply
To idenfy the terminals to which a standard plug adapter is to be
connected
Transmier works with a landline telephone
Transmier works with a wireless broadband kit
Transmier works with a cellular adapter
Transmier does not work with a landline telephone
To idenfy a combined input/output connector or mode
Accessories
8
Symbol Descripon
Part number
For prescripon use only
TÜV Listed, US and Canada.
Conforms to UL60601-1.
Cered to CAN/CSA C22.2 No.601.1-M90
European conformity, axed according to the relevant provisions of AIMD
direcve 90/385/EEC and RE direcve 2014/53/EU Annex II. Hereby,
Abbo Medical declares that this device complies with the essenal
requirements and other relevant provisions of these direcves.
The full text of the European Union RE direcve 2014/53/EU declaraon of
conformity is available at the following internet address:
www.cardiovascular.abbo/int/en/hcp/products/declaraons-of-
conformity.html .
This product operates between 9 and 200 kHz with an H‑eld strength of
less than 25 dBµA/m at 10 m.
Axed to this device in accordance with European Council Direcves
2002/96/EC.
These direcves call for separate collecon and disposal of electrical and
electronic equipment. Sorng such waste and removing it from other forms
of waste lessens the contribuon of potenally toxic substances into
municipal disposal systems and into the larger ecosystem.
Return the device to Abbo Medical at the end of its operang life.
Ingress Protecon Rang. “2 ”indicates the Merlin@home enclosure is
protected against a solid object >12.5 mm. “1” indicates the enclosure is
protected against vercally falling drops of water.
Product of Malaysia
Technical Informaon
The Merlin@home™ transmier is Class II medical equipment and complies with IEC60601-1:2012 and
UL60601-1:2012 and CAN/CSA-C22.2 No. 601.1-M90. The Merlin@home transmier is a Canadian ICES-003
Class B digital apparatus. Operaon is subject to the following two condions: 1) This device may not cause
interference, and 2) This device must accept any interference that may cause undesired operaon of the
device.
NOTES:
▪ There are no user-serviceable parts in the Merlin@home transmier. No calibraon is required. Do not▪
modify the Merlin@home transmier.
▪When used under normal operang circumstances, this equipment generates no polluon.
▪
Table 1. Electrical rangs
Input/Output Rang
Transmier input 100-240 VAC, 50-60 Hz
Power consumpon (maximum) 350 - 150 mA
9
1You can use an equivalent access point instead of the wireless access point provided in the Model EX1170
Wireless Broadband Kit series. For more informaon, see Technical Support.
Table 1. Electrical rangs
Input/Output Rang
Power consumpon (standby) 3 VA
Table 2. Storage condions
Parameter Condion
Minimum Temperature -13°F (-25°C)
Maximum Temperature 158°F (70°C)
Maximum Humidity 90%
Minimum Atmospheric Pressure
(hPa)
500
Maximum Atmospheric
Pressure (hPa)
1060
Table 3. Operang condions
Parameter Condion
Minimum Temperature 50°F (10°C)
Maximum Temperature 104°F (40°C)
Maximum Humidity 75%
Minimum Atmospheric Pressure
(hPa)
700
Maximum Atmospheric
Pressure (hPa)
1060
The device may take up to two hours to reach an operang temperature of 20°C (68°F) from the minimum
storage temperature of -25°C (-13°F). The device may take up to two hours to reach an operang
temperature of 20°C (68°F) from the maximum storage temperature of 70°C (158°F).
Transmier Accessories
Landline accessories included with the transmier are:
▪Landline cable▪
▪Landline connector▪
Oponal transmier accessories are:
▪Model EX1151 Wireless USB Adapter series▪
▪Model EX1170 Wireless Broadband Kit series 1
▪
NOTE: As with all wireless communicaons, there is a very small chance that transmied informaon
might be intercepted. For added security, your transmissions to the secure server are encrypted.
Electromagnec Compability
The Merlin@home™ transmier requires special precauons with regard to electromagnec compability
(EMC) and should be used in accordance with the informaon provided in this manual.
The Merlin@home transmier complies with the requirements of the internaonal EMC standard
IEC 60601-1-2:2014 when used with the cables listed in Transmier Accessories (page 10).
The Merlin@home transmier is intended for use in the electromagnec environment specied in Tables 5
through 8. The user should ensure that it is used in such an environment.
10
2Figures in parentheses are the immunity compliance levels for each test.
WARNING: The Merlin@home transmier complies with the limits for medical devices contained in
IEC/EN 60601-1-2:2014. However, the Merlin@home transmier may cause radio interference or may
disrupt the operaon of nearby equipment. It may be necessary to migate this eect by reorienng or
relocang the receiving device or shielding the locaon.
Table 4. Guidance and manufacturer's declaraon - electromagnec emissions
Test Compliance Electromagnec Environment - Guidance
RF Emission
CISPR 11
Group 1 The Merlin@home™ transmier uses RF energy only for its internal
funcon. Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF Emission
CISPR 11
Class B The Merlin@home transmier is suitable for use in all establishments,
including domesc establishments and those directly connected to the
public low-voltage power supply network that supplies buildings used
for domesc purposes.
Harmonic
emissions IEC
61000-3-2
Class A
Voltage
uctuaons/icker
emissions IEC
61000-3-3
Complies
Table 5. Guidance and manufacturer's declaraon - electromagnec immunity
Test IEC 60601 Test Level (Actual Level) 2Electromagnec Environment - Guidance
Electrostac
Discharge (ESD)
IEC 61000-4-2
±8 kV contact
(±8 kV contact)
±15 kV air
(±15 kV air)
Floors should be wood, concrete, or ceramic
le. If oors are covered with synthec
material, the relave humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
(±2 kV for power supply lines)
±2 kV for input/output lines
(±2 kV for input/output lines)
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV line[s] to line[s]
(±1 kV line[s] to line[s])
±2 kV line[s] to earth
(±2 kV line[s] to earth)
Mains power quality should be that of a
typical commercial or hospital environment.
Voltage dips, short
interrupons and
voltage variaons
on power supply
input lines.
IEC 61000-4-11
<5% UT*; >95% dip in UT for 0.5 cycle
(<5% UT; >95% dip in UT for 0.5 cycle)
40% UT; 60% dip in UT for 5 cycles
(40% UT; 60% dip in UT for 5 cycles)
70% UT; 30% dip in UT for 25 cycles
(70% UT; 30% dip in UT for 25 cycles)
<5% UT; >95% dip in UT for 5 s
(<5% UT; >95% dip in UT for 5 s)
Mains power quality should be that of a
typical commercial or hospital environment. If
the user of the Merlin@home transmier
requires connued operaon during power
mains interrupons, it is recommended that
the Merlin@home transmier be powered
from an uninterrupble power supply or a
baery.
Power Frequency
(50/60 Hz)
Magnec Field
IEC 61000-4-8
30 A/m
(30 A/m)
Power frequency magnec elds should be at
levels characterisc of a typical locaon in a
typical commercial or hospital environment.
11
3At 80 MHz and 800 MHz, the higher frequency range applies.
4These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon and
reecon from structures, objects, and people.
Table 5. Guidance and manufacturer's declaraon - electromagnec immunity
Test IEC 60601 Test Level (Actual Level) Electromagnec Environment - Guidance
* UT is the AC mains voltage prior to applicaon of the test level.
Table 6. Guidance and manufacturer's declaraon - electromagnec immunity (conducted RF and
radiated RF)
Test IEC 60601 Test Level 3Immunity Compliance
Level
Electromagnec
Environment - Guidance
4
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
3 Vrms
[V1=3]
Portable and mobile RF
communicaons
equipment should be
used no closer to any
part of the
Merlin@home
transmier, including
cables, than the
recommended
separaon distance
calculated from the
equaon applicable to
the frequency of the
transmier.
Recommended
separaon distance:
(80 MHz to 800 MHz)
(800 MHz to 2.7 GHz)
where P is the maximum
output power rang of
the transmier in was
(W) according to the
transmier
manufacturer and d is
the recommended
separaon distance in
meters (m).
Field strengths from
xed RF transmiers, as
determined by an
electromagnec site
survey*, should be less
than the compliance
Radiated RF
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
3 Vrms
[E1=3]
12
5These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon and
reecon from structures, objects, and people.
6At 80 MHz and 800 MHz, the separaon distance for the higher frequency range applies.
Table 6. Guidance and manufacturer's declaraon - electromagnec immunity (conducted RF and
radiated RF)
Test IEC 60601 Test Level Immunity Compliance
Level
Electromagnec
Environment - Guidance
level in each frequency
range**. Interference
may occur in the vicinity
of equipment marked
with the following
symbol:
*Field strengths from xed transmiers, such as base staons for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted
theorecally with accuracy. To assess the electromagnec environment due to xed RF transmiers, an
electromagnec site survey should be considered. If the measured eld strength of the locaon in which
the Merlin@home transmier is used exceeds the applicable RF compliance level above, the
Merlin@home transmier should be observed to verify normal operaon. If abnormal performance is
observed, addional measures may be necessary, such as re-orienng or relocang the Merlin@home
transmier.
**Over the frequency range of 150 kHZ to 80 MHz, eld strengths should be less than [V1]V/m.
NOTE: The Merlin@home transmier is intended for use in an electromagnec environment in which
radiated RF disturbances are controlled. The user of the Merlin@home transmier can help prevent
electromagnec interference by maintaining a minimum distance between portable and mobile RF
communicaons equipment (transmiers) and the Merlin@home transmier as recommended below in
Table 8, according to the maximum output power of the communicaons equipment. For transmiers rated
at a maximum output power not listed in Table 8, the recommended separaon distance (d) in meters can
be esmated using the equaon applicable to the frequency of the transmier, where P is the maximum
output power rang of the transmier in was (W) according to the transmier manufacturer.
Table 7. Recommended separaon distances between portable and mobile RF communicaons
equipment and the Merlin@home transmier
Rated maximum output
power of transmier
(W)
Recommended separaon distance according to frequency of transmier (m)
5
150 kHz to 80 MHz 80 MHz to 800 MHz 6800 MHz to 2.7 GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1.0 1.2 1.2 2.3
10.0 3.8 3.8 7.3
100.0 12 12 23
The Merlin@home™ transmier requires special precauons with regard to electromagnec compability
(EMC) and should be used in accordance with the informaon provided in this manual.
The Merlin@home transmier complies with the requirements of the EMC internaonal standard IEC
60601-1-2 when used with the cables listed in Transmier Accessories (page 10).
13
7Figures in parentheses are the immunity compliance levels for each test.
8Applies only to the Merlin 2 PCS.
The Merlin@home transmier is intended for use in the electromagnec environment specied in the
following tables. The user should ensure that they are used in such an environment.
CAUTION: The Merlin@home transmier may cause radio interference or may disrupt the operaon of
nearby equipment. It may be necessary to migate this eect by reorienng or relocang the receiving
device or shielding the locaon.
Table 8. Guidance and manufacturer's declaraon — electromagnec emissions
Test Compliance Electromagnec Environment — Guidance
RF Emission
CISPR 11
Group 1 The Merlin@home™ transmier uses RF energy only for its
internal funcon. Therefore, the RF emissions are very low and
are not likely to cause any interference in nearby electronic
equipment.
Class A The Merlin@home transmier is suitable for use in all
establishments other than domesc and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domesc purposes.
Harmonic
emissions IEC
61000-3-2
Class A The Merlin@home is suitable for use in all establishments other
than domesc and those directly connected to the public low-
voltage power supply network that supplies buildings used for
domesc purposes.
Voltage
uctuaons/icker
emissions IEC
61000‑3‑3
Complies
Table 9. Guidance and manufacturer's declaraon — electromagnec immunity
Test IEC 60601 Test Level (Actual Level) 7Electromagnec Environment — Guidance
Electrostac
Discharge (ESD)
IEC 61000-4-2
±8 kV contact
(±8 kV contact)
±15 kV air
(±15 kV air)
Floors should be wood, concrete, or ceramic
le. If oors are covered with synthec
material, the relave humidity should be at
least 30%.
Electrical fast
transient/burst
IEC 61000-4-4 8
±1 kV for input/output lines
(±1 kV for input/output lines)
±2 kV for power supply lines
(±2 kV for power supply lines)
Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV line[s] to line[s]
(±1 kV line[s] to line[s])
±2 kV line[s] to earth
(±2 kV line[s] to earth)
Mains power quality should be that of a
typical commercial or hospital environment.
Power Frequency
(50/60 Hz)
Magnec Field,
IEC 61000-4-8
30 A/m
(30 A/m)
Power frequency magnec elds should be
at levels characterisc of a typical locaon in
a typical commercial or hospital
environment.
14
9UT is the a.c. mains voltage level prior to applicaon of the test level.
10 At 80 MHz and 800 MHz, the separaon distance for the higher frequency range applies.
11 These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon and
reecon from structures, objects, and people.
12 These guidelines may not apply in all situaons. Electromagnec propagaon is aected by absorpon and
reecon from structures, objects, and people.
13 At 80 MHz and 800 MHz, the separaon distance for the higher frequency range applies.
Table 9. Guidance and manufacturer's declaraon — electromagnec immunity
Test IEC 60601 Test Level (Actual Level) Electromagnec Environment — Guidance
Voltage dips,
shorts,
interrupons, and
voltage variaons
on power supply
input lines
IEC 61000-4-11
<5% UT 9[>95% dip in UT] for 0.5 cycle
(<5% UT [>95% dip in UT] for 0.5 cycle)
40% UT [60% dip in UT] for 5 cycles
(40% UT [60% dip in UT] for 5 cycles)
70% UT [30% dip in UT] for 25 cycles
(70% UT [30% dip in UT] for 25 cycles)
<5% UT [>95% dip in UT] for 5 s
(<5% UT [>95% dip in UT] for 5 s)
Mains power quality should be that of a
typical commercial or hospital environment.
If the user of the Merlin@home™
transmier requires connued operaon
during power mains interrupons, it is
recommended that the Merlin@home
transmier be powered from an
uninterrupble power supply or a baery.
Table 10. Guidance and manufacturer's declaraon - electromagnec immunity (conducted RF and
radiated RF)
Test IEC 60601 Test Level 10 Immunity Compliance
Level
Electromagnec
Environment - Guidance
11
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.7 GHz
(3 Vrms)
[V1=3]
3 V/m
[E1=3]
Portable and mobile RF
communicaons
equipment should be
used no closer to any
part of the
Merlin@home
™ transmier including
cables, than the
recommended
separaon distance 12
calculated from the
equaon applicable to
the frequency of the
transmier.
Recommended
separaon distance:
80 MHz to 800 MHz 13
15
Table 10. Guidance and manufacturer's declaraon - electromagnec immunity (conducted RF and
radiated RF)
Test IEC 60601 Test Level Immunity Compliance
Level
Electromagnec
Environment - Guidance
800 MHz to 2.7 GHz
where P is the maximum
output power rang of
the transmier in was
(W) according to the
transmier
manufacturer and d is
the recommended
separaon distance in
meters (m).
Field strengths from
xed RF transmiers, as
determined by an
electromagnec site
survey*, should be less
than the compliance
level in each frequency
range.** Interference
may occur in the vicinity
of equipment marked
with the following
symbol:
*Electromagnec site survey- Field strengths from xed transmiers, such as base staons for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV
broadcast cannot be predicted theorecally with accuracy. To assess the electromagnec environment due
to xed RF transmiers, an electromagnec site survey should be considered. If the measured eld
strength of the locaon in which the Merlin@home transmier is used exceeds the applicable RF
compliance level above, the Merlin@home transmier should be observed to verify normal operaon. If
abnormal performance is observed, addional measures may be necessary, such as re-orienng or
relocang the Merlin@home transmier.
**Over the frequency range of 150 kHz to 80 MHz, eld strengths should be less than [V1]V/m.
NOTE: The Merlin@home transmier is intended for use in an electromagnec environment in which
radiated RF disturbances are controlled. The user of the Merlin@home transmier can help prevent
electromagnec interference by maintaining a minimum distance between portable and mobile RF
communicaons equipment (transmiers) and the Merlin@home transmier as recommended in the table
below, according to the maximum output power of the communicaons equipment. For transmiers rated
at a maximum output power not listed in the table below, the recommended separaon distance (d) in
meters can be esmated using the equaon applicable to the frequency of the transmier, where P is the
maximum output power rang of the transmier in was (W) according to the transmier manufacturer.
16
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