Biotronik RUCM200 Patient Device User Manual MN004

Brochure for patients using the

Home Monitoring

Patient Device

ContentsContents

Contents

Page

What is Home Monitoring? 2

How does the patient device work? 4

Safety precautions –what to look out for 5

How to handle the patient device 8

How do I turn my mobile patient device on? 10

How do I turn my mobile patient device off? 11

When does my implant transmit messages? 14

How do I take care of the device? 15

Frequently asked questions by patients 16

Technical terms and abbreviations 18

Electronic Article Surveillance (EAS) Systems 18

Regulatory Aspects 19

Technical data 21

1

Throughout this manual many references are made to

“your doctor” for simplicity purposes. If you have a number

of doctors, these references are for the specific doctor that

follows your implanted device, pacemaker or defibrillator.

What is Home Monitoring?What is Home Monitoring?

What is Home Monitoring?

Dear Patient,

You are the recipient of an implanted pacemaker (PM) or

Implantable Cardioverter Defibrillator (ICD). Your implant

is a complex electronic device, which benefits your health

and improves your quality of life.

BIOTRONIK has developed a new feature for your implant

called,

the Home Monitoring function.the Home Monitoring function.

the Home Monitoring function.

The Home Monitoring function permits implant-related

monitoring by your doctor. Therefore, an optimal adaption

of the implant to your personal and physical needs is

possible. Your implanted device has a small wireless

transmitter that sends out signals, which have been

recorded by the device.

A patient device, provided to you for home use, receives

these signals from the implant and transmits them to a

BIOTRONIK Service Center. The implant data are com-

piled at the Service Center in a comprehensive report

known as the Cardio Report.

Service CenterService Center

Service Center

2

The Cardio Report is sent to your doctor via FAX at certain

predetermined periods decided upon by your doctor. Your

doctor can then decide whether your implant settings

should be optimized or if the therapy schedule should be

changed. If necessary, he or she will contact you about an

appointment for a follow-up examination to optimize your

pacemaker or ICD.

Because of the restricted transmission range of your

implant’s wireless transmitter, the patient device is re-

quired for receiving and forwarding the implant data.

If your patient device is not operational or too farIf your patient device is not operational or too far

If your patient device is not operational or too far

away from your implant, it does not affect the opera-away from your implant, it does not affect the opera-

away from your implant, it does not affect the opera-

tion of your implanted device. tion of your implanted device.

tion of your implanted device. In this case, your implant

still “works” as usual. Only the Home Monitoring function

is inactive. This means that messages can not be trans-

mitted to the patient device and forwarded to the Service

Center. The messages recorded by the implant can still

be transmitted and evaluated during a regular follow-up

examination. Your doctor will answer any further ques-

tions.

On the following pages you will learn interesting facts

about the patient device and how to handle it.

3

How does the patient device work?How does the patient device work?

How does the patient device work?

BIOTRONIK has developed a mobile patient device which

can always be taken with you to ensure that your personal

freedom and mobility are restricted as little as possible.

The patient unit consists of the following components:

•Mobile Patient device with internal batteries

•Charging stand with power supply set

The mobile patient device works similarly to a cellular

telephone and transmits the messages received from the

implant using the Short Message System (SMS). These

digital messages are sent from the patient device to a

BIOTRONIK Service Center. Once fully charged, the built-

in batteries ensure approximately 15 hours of operating

time. The mobile patient device remains operational while

placed on the charging stand.

LED mobile patient deviceLED mobile patient device

LED mobile patient device

LED charging standLED charging stand

LED charging stand

4

On/Off buttonOn/Off button

On/Off button

Safety precautions – What to look out forSafety precautions – What to look out for

Safety precautions – What to look out for

The patient device and its components were developed,

produced and tested according to the latest guidelines and

standards. It meets the strict regulations for medical

devices. So that your patient device functions without

problems, the following safety measures must be carried

out:

Do not use the patient device in areas where a cellularDo not use the patient device in areas where a cellular

Do not use the patient device in areas where a cellular

phone is forbidden – hospitals, aircraftphone is forbidden – hospitals, aircraft

phone is forbidden – hospitals, aircraft,,

,,

, etc etc

etc etc

etc..

..

.

Switch your patient device off before you enter areas

where cellular phones are forbidden.

!!

!

!!

!Keep a minimum distance between the mobile patientKeep a minimum distance between the mobile patient

Keep a minimum distance between the mobile patientKeep a minimum distance between the mobile patient

Keep a minimum distance between the mobile patient

device and your implant.device and your implant.

device and your implant.

Your mobile patient device, similar to cellular telephones,

can effect your implant if the distance between the mobile

patient device and the implant is less than 15 cm (about

6 inches). To prevent disturbances, please keep the

patient device at least this minimum distance from your

implant. You can keep the mobile patient device in the

supplied soft case, and transport it attached to your belt.

Do not place the patient device directly over your implant.

Do not carry the patient device inside the breast pocket of

your shirt.

5

Protect the patient device from external influencesProtect the patient device from external influences

Protect the patient device from external influences

such as:such as:

such as:

–Water immersion

–High humidity (e.g., in the bathroom)

–High temperatures >40°C (104ºF)

–Low Temperatures <5°C (41ºF)

–Extreme pressures

–Violent shocks or other strong mechanical influences

–Bending the charging contacts on the charging stand

–Placing conductive items in the charging stand (such as

coins)

–Intensive light sources (direct sunlight, strong halogen

bulbs)

–Detergents, solvents, acids and bases

!!

!

!!

!

!!

!The patient device may only be opened and repairedThe patient device may only be opened and repaired

The patient device may only be opened and repairedThe patient device may only be opened and repaired

The patient device may only be opened and repaired

by authorized qualified personnel.by authorized qualified personnel.

by authorized qualified personnel.

If the device is damaged, please return it to your doctor.

The batteries (type LG ICR 18650) installed by qualified

personnel must also be replaced by these specialists.

Do not use a damaged patient device.Do not use a damaged patient device.

Do not use a damaged patient device.

Verify that none of the components are damaged before

usage. Only use the following original parts from

BIOTRONIK: The mobile patient device RUCM 200, the

charging stand RUCL 1000 and the corresponding power

supply (12Vdc @600mA, UL 2601-1 certified).

6

Handle the antenna with care.Handle the antenna with care.

Handle the antenna with care.

Modifying or sticking other materials on the antenna

interfere with the transmission qualities of the patient

device.

In the following cases, return the patient device toIn the following cases, return the patient device to

In the following cases, return the patient device to

your doctor or to the clinic that issued the device:your doctor or to the clinic that issued the device:

your doctor or to the clinic that issued the device:

–Your patient device does not function anymore.

–You do not need it anymore.

Do not dispose of the device in household garbage.Do not dispose of the device in household garbage.

Do not dispose of the device in household garbage.

Because of the rechargeable batteries (Lithium-ion

batteries), the device must be disposed of separately.

!!

!

!!

!

!!

!

7

How do I handle the patient device?How do I handle the patient device?

How do I handle the patient device?

Below describes how to begin operating and how to use

your patient device.

What must be done before starting to use the patientWhat must be done before starting to use the patient

What must be done before starting to use the patient

device?device?

device?

Find a safe place for the device. That means:

•The device cannot be knocked to the floor or dropped.

•It is not too warm or too humid (not in a bathroom).

•The device is not in direct sun light.

Normally, a bedside table is a suitable place. When you

sleep, the distance between your implant and the patient

device should not be more than approximately two meters

(about 6 feet). In this way, during the night your implant

data can be successfully transmitted to the patient device.

8

How do you connect the device?How do you connect the device?

How do you connect the device?

Check that the operating voltage of your power cord

matches the outlet in your home (normally 120 Vac,

60Hz).

If both voltages correspond, insert the plug of the power

cord into the wall-socket. The power supply cord has a

small plug at the opposite end of the cable. Connect this

plug to the socket that is located in the back of the charg-

ing stand.

11

1

22

2

Insert the plug of the power supply

unit into the wall socket

Connect the small end of the

power cord to the socket in the

patient device’s charging stand.

9

11

1

22

2

Push the button on the side of the

mobile patient device until a short beep

is heard.

The light on the top of the patient device

will begin to flash orange for approxi-

mately 0.5 to 2 minutes.

When the light begins flashing green,

your patient device is ready for use.

33

3

How do I turn the mobile patient device on?How do I turn the mobile patient device on?

How do I turn the mobile patient device on?

10

If the light alternately flashes two times green and two

times orange, your patient device is not able to log onto

the local cellular phone system. In this instance, please

place your device in another location which may receive a

stronger signal from the cellular network. Once opera-

tional, the light will begin to flash green.

Note: When changing locations, turn the patient device off

and then on again (i.e. switch off, find new location, switch

on again).

11

1

22

2

33

3

11

1

22

2

How do I turn the mobile patient device off?How do I turn the mobile patient device off?

How do I turn the mobile patient device off?

Note: The system is operational while charging if the

mobile patient device has been left on. This is the prefer-

able method. Usually, the charging operation takes no

longer than 5 hours. It is acceptable to permanently keep

the patient device in the charger stand.

The unit is off, and no further data can

be received or transmitted.

Push and hold the power button on the

side of the patient device until a short

“beep” is heard and the light goes out.

How do I recharge the batteries of theHow do I recharge the batteries of the

How do I recharge the batteries of the

mobile patient device?mobile patient device?

mobile patient device?

Place the mobile device onto the charg-

ing stand. Charging begins immediately.

Charging will occur whether the mobile

patient device is on or off.

During charging, the light on the charg-

ing stand is orange.

When the batteries are recharged, the

light turns green again.

11

How do I know if the batteries are low or discharged?How do I know if the batteries are low or discharged?

How do I know if the batteries are low or discharged?

If the battery charge falls below 10% of the maximum

charge, the light on the top of the mobile patient device

flashes red. At the same time, 3 short beeps will be heard.

When this occurs, recharge the mobile patient device in

the charging stand.

How can I see if the patient device is transmittingHow can I see if the patient device is transmitting

How can I see if the patient device is transmitting

messages?messages?

messages?

When a message is being transmitted, the light on top of

the patient device will flash orange for as long as two

minutes. Transmission of data is conducted automatically

at certain intervals as determined by your doctor. The

message transmission by the implant is repeated several

times in an interval of 8 to 9 minutes.

TT

Transmission of messaransmission of messa

ransmission of messaransmission of messa

ransmission of messagg

gg

gee

ee

e

During the entire message transmission,

the light on the mobile patient device

flashes orange.

After the transmission is finished, the

light flashes green again.

11

1

22

2

12

What do I do if the mobile patient device does notWhat do I do if the mobile patient device does not

What do I do if the mobile patient device does not

function any more?function any more?

function any more?

If the patient device does not function (i.e., the light is out

and there is no beep), place the device in the charging

stand to recharge it.

If the device does not function after recharging, first push

the Reset button on the back of the mobile patient device

with a pointed object. Then switch the device on, using

the power on button on the side – as described on page 9.

If the light does not flash green after 5 minutes, please

inform your doctor.

ResetReset

Reset

Push the Reset button on the back of

the patient device with a pointed object.

Push and hold the power on button on

the side of the patient device until a

short beep is heard.

11

1

22

2

13

When does my implant transmitWhen does my implant transmit

When does my implant transmit

messages?messages?

messages?

Your doctor can adjust your implanted device so that it can

transmit messages under certain circumstances. There

are two possible ways to activate a message transmission:

Periodically after a predefined time interval. ThisPeriodically after a predefined time interval. This

Periodically after a predefined time interval. This

interinter

intervv

vv

val is set bal is set b

al is set bal is set b

al is set by yy y

y yy y

y your doctorour doctor

our doctorour doctor

our doctor..

..

.

The doctor has adjusted your implant so that it transmits

periodic messages at a certain time and at periodic

intervals (for example: every night at 2:00 am).

22

2

11

1

TT

Transmission activransmission activ

ransmission activransmission activ

ransmission activated bated b

ated bated b

ated by a special may a special ma

y a special may a special ma

y a special magnetgnet

gnetgnet

gnet

(pacemaker patients only)(pacemaker patients only)

(pacemaker patients only)

In certain cases, the transmission of data can be activated

by placing a special magnet directly over the implant.

Your doctor will explain to you if, how and when you

should do this.

Please use this function only if your doctor requests it and

gives you a suitable magnet. Your doctor must program

this function for your implant.

Note: Patients with implantable cardioverter defibrillators

should not place a magnet over your chest, as this inter-

feres with the proper functioning of your ICD.

!!

!

14

How do I take care of the device?How do I take care of the device?

How do I take care of the device?

In order to use the patient device over a long period of

time, it is necessary to treat the device with care. The

faultless operation of the device can only be ensured

when the following conditions are observed:

Keep the device clean and away from dirty or dusty

environments.

To clean, use a soft cloth. Moisten the cloth with water

when necessary. Avoid direct contact of the device with

water.

If the patient device does not work, return it to your doctor.

11

1

22

2

33

3

15

Frequently asked questions by patientsFrequently asked questions by patients

Frequently asked questions by patients

What happens if I forget to recharge my mobile patientWhat happens if I forget to recharge my mobile patient

What happens if I forget to recharge my mobile patient

device?device?

device?

The batteries generally supply power for about 15 hours.

If the light on the mobile patient device turns red, place the

device on the charging stand until the light turns green

again (usually up to 5 hours). During the recharging

process, the light on the charging stand is orange. If the

mobile patient device is not recharged, the functions of the

patient device are affected and no message can be

received and transmitted to the Service Center.

There is no health risk if the patient device is not re-

charged because the regular functions of your implant are

independent of the patient device.

What happens if the patient device fails? Does thatWhat happens if the patient device fails? Does that

What happens if the patient device fails? Does that

affect my implant?affect my implant?

affect my implant?

No. Your implant “works ”as usual. During a failure of the

mobile patient device, only the Home Monitoring function

is no longer available. This means that messages can not

be transmitted via the patient device to your physician.

The messages are still recorded by the implant and can be

transmitted and evaluated during a regular follow-up

examination with your doctor.

Try to turn it on again and to recharge the mobile patient

device. If this does not work, inform your doctor and

follow his instructions.

??

?

??

?

16

Can I take my patient device with me everywhere–Can I take my patient device with me everywhere–

Can I take my patient device with me everywhere–

shopping, walking, sports?shopping, walking, sports?

shopping, walking, sports?

Yes. You can always take your mobile patient device with

you during your private and working activities, as long as

your doctor recommends it and you are not within areas

where cellular phones are not permitted. The mobile

patient device can be comfortably transported attached to

your belt in the supplied soft case. It is also possible to

carry it in a normal bag or backpack. The distance be-

tween implant and patient device should not be more than

approximately two meters (about 6 feet), but must be at

least 15 cm (6 inches). The patient device is supplied with

a big carrying case for convenient and secure transporta-

tion and travelling.

What do I have to do when I go on vacation/travelling?What do I have to do when I go on vacation/travelling?

What do I have to do when I go on vacation/travelling?

Consult your doctor beforehand and inform him/her of your

travel plans. You can take the patient device with you

everywhere and connect it where there is a suitable power

outlet (120 Vac, 60Hz). A country-specific adapter may be

necessary when travelling outside of the U.S. Your doctor

will give you detailed information. When transporting the

device on airlines, the regulations for cellular telephones

must be followed (e.g., do not use the patient device

during a flight).

??

?

??

?

17

TT

Tecec

ecec

echnical terms and abbrehnical terms and abbre

hnical terms and abbrehnical terms and abbre

hnical terms and abbreviationsviations

viationsviations

viations

SMSSMS

SMS

Short Message Service – This is a digital communication

system for mobile phones.

Cardio ReportCardio Report

Cardio Report

Short report containing the current therapy status of the

patient on the basis of data transmitted from the implant.

Home MonitoringHome Monitoring

Home Monitoring

Technical feature of pacemakers and ICDs used to

transmit messages over a certain frequency and make

them available to your doctor.

Service CenterService Center

Service Center

Location where implant data is received, analyzed and

forwarded to your doctor.

ElectrElectr

Electronic Aronic Ar

onic Aronic Ar

onic Artictic

tictic

ticle Surle Sur

le Surle Sur

le Surveillance (EAS)veillance (EAS)

veillance (EAS)veillance (EAS)

veillance (EAS)

SystemsSystems

Systems

Equipment such as retail theft prevention systems may

interact with pulse generators. Patients should be advised

to walk directly through and not to remain near an EAS

system longer than necessary.

18

RegulatorRegulator

Regulatory aspectsy aspects

y aspectsy aspects

y aspects

Your implant is equipped with an RF transmitter for wire-

less communications to the patient device. These mes-

sages are transmitted via a radio frequency assigned by

the Federal Communications Commission for Medical

Implant Communications Service (MICS).

The transmitter is authorized by rule under the Medical

Implant Communications service (47 CFR Part 95) and

must not cause harmful interference to stations operating

in the 400.150 - 406.000 MHz band in the Meteorological

Aids (i.e., transmitters and receivers used to communicate

weather data), the Meteorological Satellite, or the Earth

Exploration Satellite Services and must accept interfer-

ence that may be caused by such aids, including interfer-

ence that may cause undesired operation. This transmit-

ter shall be used only in accordance with the FCC rules

governing the Medical Implant Communications Service.

Analog and digital voice communications are prohibited.

Although this transmitter has been approved by the

Federal Communications Commission, there is no guaran-

tee that it will not receive interference or that any particular

transmission from this receiver will be free from interfer-

ence.

The FCC ID number for this device is PG6BA0T

The patient device, as well as the implant itself, are tested

by an independent regulatory authorities such as the FCC,

to comply with the appropriate standards and regulations.

The patient device uses a GSM-Modem that connects to

the mobile cellular telephone service at (1900 MHz).

BIOTRONIK uses the modem according to the specifica-

tions of the manufacturer and in compliance with FCC

approval requirements.

19

20

For body worn operation, this device has been tested and

meets the FCC RF exposure guidelines when used with a

Biotronik, Inc. accessory designated for this product, or

when used with an accessory that contains no metal and

that positions the device a minimum of 0.5 cm from the

body.

powerpower

power chargingcharging

chargingcharging

charging mobilemobile

mobilemobile

mobile

supplysupply

supply standstand

standstand

stand patient devicepatient device

patient devicepatient device

patient device

Model /typeModel /type

Model /type 120Vac, 600mA* RUCL 1000 RUCM 200

VV

Voltaolta

oltaolta

oltagg

gg

ge/e/

e/e/

e/ 120 Vac±10%, 12 V dc, 9 V DC,

power inputpower input

power input 60 Hz 600 mA 500 mA

VV

Voltaolta

oltaolta

oltagg

gg

ge/e/

e/e/

e/ 12 Vdc DC/ 9 V dc, –

power outputpower output

power output 600 mA 500 mA

StocStoc

Stock and k and

k and k and

k and TT

TT

Transporranspor

ransporranspor

ransportation Conditionstation Conditions

tation Conditionstation Conditions

tation Conditions

temperaturetemperature

temperature +5° C to +55° C

humidityhumidity

humidity 93% relative humidity

air pressureair pressure

air pressure 50 mbar to 1250 mbar

TT

Tecec

ecec

echnical Datahnical Data

hnical Datahnical Data

hnical Data

* UL 2601-1 certified

21

AddressesAddresses

Addresses

BIOTRONIK, Inc.

6024 SW Jean rd. Bldg. B

Lake Oswego, OR 97035

Phone (800) 547-0394 (24-hr)

FAX (503) 635-9936

BIOTRONIK, Inc.

6024 SW Jean rd. Bldg. B

Lake Oswego, OR 97035

Phone (800) 547-0394 (24-hr)

FAX (503) 635-9936

M4039-C 5/02

MN004r1 5/02

Biotronik RUCM200 Patient Device User Manual MN004

Biotronik, Inc. Patient Device MN004

users manual

Navigation menu

Namespaces

Views

Navigation