DeVilbiss DV6WM Manual
EN DV6WM DeVilbiss Wireless Modem Instruction Guide
Made in USA of US and Imported Parts.
ES Guía de instrucciones del Módem inalámbrico DV6WM de DeVilbiss
Hecho en EE. UU. con piezas nacionales e importadas.
FR Guide d’utilisation du Modem sans fil DV6WM DeVilbiss
Fabriqué aux États-Unis avec des pièces des États-Unis et des pièces importées.
C US
EN - 2 SE-DV6WM-1
ENGlISH ................................................................... EN-2
ESPAÑOL ................................................................ ES-14
FRANÇAIS ............................................................... FR-26
TABLE OF CONTENTS
Intended Use........................................................................... EN - 2
Contraindications..................................................................... EN - 2
Symbols................................................................................... EN - 2
Important Safeguards.............................................................. EN - 3
Cautions / Warnings............................................................ EN - 3
Package Contents................................................................... EN - 4
Important Parts........................................................................ EN - 4
Set Up & Operation - DV6x Series CPAP............................... EN - 5
Initial Set Up of Your Wireless Modem............................... EN - 5
Operating your Wireless Modem ........................................ EN - 6
Charging the Modem Battery .................................................. EN - 7
Cleaning / Maintenance / Disposal.......................................... EN - 8
Specifications ............................................................................. EN - 9
Troubleshooting.......................................................................... EN - 10
EMC Information ........................................................................ EN - 11
Do not use the device or accessories in an environment with
electromagnetic equipment such as CT scanners, Diathermy, RFID and
electromagnetic security systems (metal detectors) as it may cause
unacceptable risk to the patient or damage to the device. Some
electromagnetic sources may not be apparent, if you notice any
unexplained changes in the performance of this device, if it is making
unusual or harsh sounds, disconnect the power cord and discontinue
use. Contact your home care provider.
SYMBOLS
Test Call Button Manufacturer
Cell Phone Status LED Date of Manufacture
Bluetooth Status LED DC voltage symbol
Battery Status LED Model number
Battery Charge Connector Serial Number
Refer to Operating
Instructions EC REP European Representative
Radio transmitter MR Unsafe – Unsafe for
Magnetic Resonance
Environment
IP21
Ingress Protection - Protected against nger access to
hazardous parts; protected against vertically falling water
drops
Rx
Only
CAUTION - USA Federal law restricts this device to sale by or
on the order of physician
This device contains electrical and/or electronic equipment
that must be recycled per EU Directive 2012/19/EU- Waste
Electrical and Electronic Equipment (WEEE)
INTENDED USE
The DeVilbiss Healthcare DV6WM Wireless Modem is intended for
use as an accessory to a DV6x Series CPAP and DV5x Series CPAP
with SmartLink II Bluetooth module for patients in a home or
healthcare environment.
CONTRAINDICATIONS MR Unsafe
Do not bring the device or accessories into a Magnetic Resonance
(MR) environment as it may cause unacceptable risk to the patient or
damage to the device or MR medical devices. The device and
accessories have not been evaluated for safety in an MR environment.
EN - 3SE-DV6WM-1
IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS BEFORE
USING THIS DEVICE.
SAVE THESE INSTRUCTIONS.
(per IEC 60601-1-2:2007 Section 5.2.2.1 b)
WARNING: The use of ACCESSORIES, transducers and cables
other than those specied, with the exception of transducers and
cables sold by DeVilbiss Healthcare as replacement parts for
internal components, may result in increased EMISSIONS or
decreased IMMUNITY of the ME EQUIPMENT or ME SYSTEM.
(per IEC 60601-1-2:2007 Section 5.2.2.1 d)
WARNING: The DeVilbiss DV6WM Wireless Modem should not be
used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the DeVilbiss DV6WM
Wireless Modem should be observed to verify normal operation
in the conguration in which it will be used.
(per IEC 60601-1-2:2007 Section 5.2.2.5)
WARNING: The DeVilbiss DV6WM Wireless Modem may be
interfered with by other equipment, even if that other equipment
complies with CISPR EMISSION requirements.
RF receiver frequency band BT 2.402 GHz ~ 2.480 GHz
RF receiver bandwidth BT 2.402 GHz ~ 2.480 GHz
RF receiver frequency band GSM 824.2 MHz ~ 1907.6 MHz
RF receiver bandwidth GSM 824.2 MHz ~ 1907.6 MHz
(per IEC 60601-1-2:2007 Section 5.2.2.5)
RF transmit frequency band BT 2.402 GHz ~ 2.480 GHz
Modulation BT GFSK, 8DPSK
Effective Radiated Power BT < -10 dBm (100 mW)
RF transmit frequency band GSM 824.2 MHz ~ 1907.6 MHz
Modulation GSM 8-PSK, WCDMA
Effective Radiated Power GSM < +33 dBm(2,000 mW)
CAUTIONS / WARNINGS
• Refer to International Standard IEC 60601-1 Ed 3.0 Amendment
1 for safety requirements applicable to Medical Electrical
Systems.
• Electric shock hazard-Do not attempt to open or remove the
Wireless Modem or charger cabinet; there are no user-
serviceable components inside. If service is required, contact
your equipment provider for instructions on obtaining service.
Opening or attempting to service your device will void the
warranty.
• Do not perform service or maintenance while the Wireless
Modem is in use.
• Wireless Modem contains Lithium Polymer (LiPO) battery. Do
not dispose of in household waste.
• The replacement of lithium batteries by inadequately trained
personnel could result in a HAZARD. There are no user
serviceable parts inside the DV6WM Wireless Modem, the
modem should only be serviced by a qualied DeVilbiss
provider.
• If the Wireless Modem begins to perform in an unusual
manner or a way not described in this guide, do not attach the
Wireless Modem to a charger or any other equipment. Contact
your equipment provider and report the unusual performance.
• If Wireless Modem is exposed to extreme temperatures or
humidity during storage, allow the device to sit at room
temperature for 2 hours before operating or charging.
• Do not connect the DV6WM Wireless Modem to equipment not
described in these instructions. Connecting the modem to
other equipment or accessories may result in malfunction or
damage to the DV6WM Wireless Modem.
• Do not modify the DV6WM Wireless Modem or accessories
this may result in malfunction or damage to the DV6WM
Wireless Modem.
EN - 4 SE-DV6WM-1
IMPORTANT PARTS
Wireless Modem – Control Panel
Test Call button
Press to confirm LEDs illuminate
Cell Phone
(link to server) Bluetooth (link to CPAP) Battery Battery charging
connector (USB)
DV6WM-122 Rev. C
Reset (do not press unless
instructed by your provider)
Normal Operation
The battery LED ashes when battery is low, otherwise all LEDs remain OFF except during call
sequence. During the call, the battery LED illuminates solid and either Bluetooth or Cell LEDs are
also active. You may not see this happen.
Call frequency has been preset by your provider.
NOTE: When battery LED ashes, refer to Charging the Modem Battery.
NOTE: To check operation at any time, press the test call button and conrm LEDs illuminate.
• Use only chargers and charging
cables provided by DeVilbiss for use
with the DV6WM Wireless Modem.
Use of other chargers or charging
cables may result in malfunction or
damage to the DV6WM Wireless
Modem.
For storage and handling – The
following conditions may cause a re
hazard by causing a failure of the
internal rechargeable battery:
• Never attempt to charge a Wireless
Modem with physical damage.
• If Wireless Modem temperature
exceeds 50˚C (122˚F), terminate
charging.
• Do not heat or throw Wireless
Modem into a re.
• Do not use or store Wireless Modem
close to re or inside the car where
temperature may be over 60˚C.
• Do not immerse the Wireless Modem
in water.
CAUTIONS / WARNINGS
DV6WM Wireless
Modem
USB Wall
Charger
Instruction Guide
PACKAGE CONTENTS
EN - 5SE-DV6WM-1
SET UP & OPERATION - DV6x Series CPAP
Initial Set Up of Your Wireless Modem
NOTE: Fully charge battery before beginning set up. Refer to Charging
the Modem Battery.
2. Press Test Call button on Wireless
Modem
a. All LEDS will illuminate for
approximately 1 second, then
turn OFF
b. Battery LED shows battery
status
c. Bluetooth LED will begin ashing
slowly while searching for CPAP
3. Pair with DV6x Series CPAP
a. Modem bluetooth LED will begin
ashing fast when ready to pair
with CPAP (approximately 30
seconds for fast ash to begin)
b. The wireless modem serial
number will appear on the list
when the CPAP nds it
NOTE: Wait until Modem appears
in list, this may take 30 seconds.
DV6WM 122 Rev C
DV6WM 122 Rev C
PRESS
DV6WM 122 Rev C
DV6WM 122 Rev C
4. The Cell Phone LED on
the modem will ash and
then turn solid for a few
minutes
1. Check DV6X CPAP to ensure
Bluetooth is ON
a. Navigate to ADD-ONS
b. Select Bluetooth
c. Press to toggle from OFF to ON
if necessary
c. At Click Item to Pair
screen, select
Wireless Modem
serial number and
press, the menu will
show “Pairing…” then
“Success”
d. The Bluetooth LED on
the Wireless Modem
will stop ashing and
stay ON while reading
data from the CPAP
PRESS
DV6WM 122 Rev C
5. Find a location where Cell
Phone LED is ON (not
ashing) and place the
modem where it will not
be disturbed
NOTE: Bluetooth and Cell
Phone LEDs will normally be
OFF; they will be active only
when modem is talking to
CPAP or to the server; you
may not see this happen.
Leave modem alone.
6. After call sequence is
nished, all LEDs will turn
OFF
DV6WM 122 Rev C
PRESS
EN - 6 SE-DV6WM-1
SET UP & OPERATION - DV6x Series CPAP
To see modem info, select Wireless Modem in the ADD
ONS menu on the DV6x CPAP and press.
Info shown on DV6x CPAP display for Wireless Modem
Days since last upload to server
Wireless Modem ID
Bluetooth Signal
Cell Phone Signal
Battery Level
PRESS
The DeVilbiss Wireless Modem operates without interaction as long as the battery level is good.
Operating your Wireless Modem with Your DV6x Series CPAP
NOTE: The DV6x Series CPAP will report low modem battery.
When you see this message, refer to Charging the Modem
Battery. The low battery message appears when blower is turned
ON.
EN - 7SE-DV6WM-1
CHARGING THE MODEM BATTERY
The Battery LED will ash 3 times in 1 second every 3 seconds when the battery level gets low. If the Battery LED is ashing, plug the provided
USB Wall Charger into the modem and the wall outlet.
Battery LED on the modem will:
• Flash slowly when battery is charging
• Stay on steady when battery is fully charged and connected to the power source
NOTE: If desired, the modem can be plugged in at all times.
The DV6WM Wireless modem operates normally while the battery is charging. The modem may be left plugged into the charger for an extended
period of time.
Typical operation time of theDV6WM Wireless Modem on a full battery charge is 90 days.
DV6WM 122 Rev C
USB Wall
Charger
Wall Outlet
When the battery level gets low,
the Battery LED on the modem
will ash. Refer to Charging
the Modem Battery.
DV6WM 122 Rev C
flashes when low
EN - 8 SE-DV6WM-1
CLEANING INSTRUCTIONS
1. Clean modem once per month. Unplug Wireless Modem from
charger and wipe outside surface with a damp cloth.
2. Store Wireless Modem in a dry place at room temperature when
not in use.
Multi-Patient Use
If the device is to be used by multiple persons in a healthcare
environment or device rental program, the outside of the device must
be cleaned and disinfected between patients.
Cleaning for Multi-Patient Use
WARNING
If you are using the device on multiple patients, complete the
following steps to clean the outside of the device only before
each new user.
1. Unplug the device before cleaning.
2. Use a cloth with a solution of mild detergent (e.g. Dawn
dishwashing liquid) and water to remove debris if necessary.
3. Use a cloth with a 1:10 dilution of 5.25%–6.15% sodium
hypochlorite (i.e., household bleach) to clean the exterior of the
device.
4. Ensure that the device is completely dry before plugging in the
power cord.
MAINTENANCE
WARNING
Electric shock hazard-Do not attempt to open or remove the
Wireless Modem or charger cabinet; there are no user-
serviceable components inside. If service is required, contact
your equipment provider for instructions on obtaining service.
Opening or attempting to service your device will void the
warranty.
The Wireless Modem and accessories require no maintenance
through the expected service life.
EXPECTED SERVICE LIFE
DV6WM Wireless Modem ............................................5 years
AC to DC USB wall charger ........................................ 2 years
DISPOSAL
CAUTION: Wireless Modem contains Lithium Polymer (LiPO) battery.
Do not dispose of in household waste.
Wireless Modem and charger contain electronic waste, contact local
authorities to determine proper method of disposal of electronic parts,
plastic parts and LiPO battery.
NETWORK/DATA COUPLING
• Connection of the DV6WM Wireless Modem to a network/data
coupling that includes other equipment could result in previously
unidentied risks to patients and operators, and the responsible
organization should identify, analyze, and control such risks;
• Subsequent changes to network/data coupling may introduce new
risks, requiring new analysis;
Changes to network/data coupling include:
• Changes in network/data coupling conguration
• Connection of additional items to network/data coupling
• Disconnecting items from network/data coupling
• Update of equipment connected to network/data coupling
• Upgrade of equipment connected to network/data coupling
EN - 9SE-DV6WM-1
SPECIFICATIONS
Size ...........................................................................................................................................................4.4”H x 3”W x 1”D (11.2cm x 7.6cm x 2.5cm)
Weight ................................................................................................................................................................................................ 0.35 lbs. (158.8 g)
Electrical Requirements AC ....................................................... 100 – 240 VAC, 50/60 Hz, 120 mA (Specified external AC to DC USB charger input)
Electrical Requirements DC ................................................................. 4.74 to 5.25 VDC, 500 mA (Specified external AC to DC USB charger output)
Maximum Power Consumption ................................................................................................................................3 watts from AC to DC USB charger
Operating Temperature Range ..............................................................................................................................................41˚F to 104˚F (5˚C to 40˚C)
Operating Humidity Range ........................................................................................................................................... 15% to 95% RH non-condensing
Operating Atmospheric Conditions .....................................................................................700 hPa to 1060 hPa (~9800 ft to ~ 1400ft below sea level)
Storage & Transportation Temperature Range ............................................................................................................. 13˚F to +158˚F (-25˚C to +70˚C)
Storage & Transportation Humidity Range .................................................................................................................... 0% to 95% RH non-condensing
Technical Specs (per IEC 60601-1-2:2007 Section 5.2.2.1 a)
Cables compatible with the DeVilbiss DV6WM Wireless Modem........................................ USB to Micro B USB cable, max cable length = 6 ft (1.8m)
USB Wall Charger........................................................................................................................................................ Input 100 - 240 VAC, 47 – 63 Hz
Output 5 VDC, 3 Watt max
Output connector USB Micro B
Max cable length = 6 ft (1.8 m)
Wireless Specications: Bluetooth
This medical device contains two radio transmitters, Bluetooth and 3G cellular. The Bluetooth radio integrated into this device is active when the
Bluetooth Status LED ( ) on the control panel is illuminated. Bluetooth is used to connect wirelessly to your medical device. The 3G cellular radio
integrated into this device is active when the Cell Phone Status LED ( ) on the control panel is illuminated. The 3G cellular radio is used to send
data read from your medical device to a remote data server. If you notice any unexplained changes in the performance of the wireless function or
your device, turn the Bluetooth radio off to see if that is the cause. You may experience issues with wireless technology such as delays in displayed
or stored data, artifact or gaps in the data due to information lost during wireless transfer.
Radio Technology................................................................................................................................................. Bluetooth 2.1 +EDR and Bluetooth 4.0
Bluetooth Power Class..................................................................................................................................................................................................1.5
Network Topology......................................................................................................................................................................................... Point to Point
Bluetooth Profile Supported ........................................................................................................................................................................................SPP
Effective Range............................................................................................................................................................................50 meters (line of sight)
Effective Radiated Power..................................................................................................................................................................... 10 dBm (100 mW)
Radio frequency band (Tx and Rx).............................................................................................................................................2.402 GHz ~ 2.480 GHz
Minimum Separation Distance (to other RF transmitters).............................................................................................................................1 cm (0.4 in.)
EN - 10 SE-DV6WM-1
Wireless Specifications 3G Cellular:
Radio Technology ........................................................................................................................................................................................... 3G Cellular
Network Topology ....................................................................................................................................................................................... Point to Point
Effective Radiated Power.................................................................................................................................................................... max 33 dBM (2 W)
Radio frequency band (Tx and Rx)...........................................................................................................................................824.2 MHz ~ 1907.6 MHz
Minimum Separation Distance (to other RF transmitters).............................................................................................................................1 cm (0.4 in.)
Quality Of Service Required................................................................................................................................................................1 Bar (> -124 dBM)
Security Requirements:
Authentication............................................................................................................................. Enforced on all data channels (outgoing and incoming)
Encryption..............................................................................................................................................................................................Base 64 encoding
TROUBLESHOOTING
CAUTION: If the Wireless Modem begins to perform in an unusual manner or a way not described in this guide, do not attach the Wireless Modem
to a charger or any other equipment. Contact your equipment provider and report the unusual performance.
CAUTION: If Wireless Modem is exposed to extreme temperatures or humidity during storage, allow the device to sit at room temperature for 2
hours before operating or charging.
Issue Possible Cause Remedy
Nothing happens after pressing
the test call button. 1. Wireless Modem battery is discharged. 1. Plug Wireless Modem into charger and allow battery to
charge for at least 2 hours.
2. Test call button is not working properly. 2. & 3. Contact your equipment provider for service.
3. Malfunction of the modem.
Unable to pair Wireless Modem
with a CPAP. 1. CPAP does not have Bluetooth. 1. Wireless Modem only works with DeVilbiss CPAPs that
have Bluetooth feature.
2. CPAP Bluetooth is not turned on. 2. Turn Bluetooth on in CPAP menu, see instructions.
3. Wireless Modem is too far away from CPAP. 3. Move modem closer to CPAP, must be within 30m of
each other.
Battery LED ashes fast three
times in a row. 1. Battery charge is low. 1. Allow Wireless Modem to sit at room temperature for 2
hours, attach charger to charge battery.
Wireless Modem does not
charge, Battery LED does not
light when connected to charger.
1. Charger may not be working 1. Try using another charger, one that is approved for use
with the Wireless Modem.
2. Malfunction of Wireless Modem 2. Contact your equipment provider for service.
LEDs ashing in a pattern not
explained in this guide. 1. Malfunction of Wireless Modem 1. Contact your equipment provider for service.
Contact your equipment provider if you need assistance setting up, using or maintaining your Wireless Modem.
Report unexpected operation or events to your equipment provider or DeVilbiss Customer Service 800-338-1988. See back cover of guide for other DeVilbiss
ofce locations.
EN - 11SE-DV6WM-1
EMC INFORMATION
(per IEC 60601-1-2:2007 Section 5.2.1.1)
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC and needs to be installed and put into service according to the
EMC information provided in this instruction guide.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT
(per IEC 60601-1-2:2007 Section 5.2.2.1 c)
Guidance and Manufacturer’s Declaration –
Electromagnetic Emissions
The DeVilbiss DV6WM Wireless Modem is intended for use in the
electromagnetic environment specied below. The customer or the
user of the DeVilbiss DV6WM Wireless Modem should assure that it
is used in such an environment.
Emissions Test Compliance
Electromagnetic Environment –
Guidance
RF Emissions
CISPR 11 Group 2
This device uses RF energy only for
its internal function. Therefore, its RF
emissions are very low and are not
likely to cause any interference in
nearby electronic equipment.
RF Emissions
CISPR 11 Class B This device is suitable for use in all
establishments including domestic,
and those directly connected to the
public low-voltage power supply
network that supplies buildings used
for domestic purposes.
Harmonics IEC
61000-3-2 Class A
Voltage Fluctuations/
Flicker Emissions
IEC 61000-3-3
Complies
(per IEC 60601-1-2:2007 Section 5.2.2.1 f)
Immunity Test IEC 60601 test level Compliance level Electromagnetic Environment
– Guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±8kV contact
±15kV air
±8kV contact
±15kV air
Floors should be wood, concrete
or ceramic tile. If oors are
covered with synthetic material,
the relative humidity should be at
least 30 %.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply
lines
±1 kV for input/output
lines
±2 kV for power
supply lines
±1 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)
±2 kV line(s) to earth ±1 kV line(s) to line(s)
±2 kV line(s) to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
>95 % dip in UT for 0.5
cycle
60 % dip in UT for 5
cycles
30 % dip in UT for 25
cycles
>95 % dip in UT for 5
seconds
>95 % dip in UT for
0.5 cycle
60 % dip in UT for 5
cycles
30 % dip in UT for 25
cycles
>95 % dip in UT for 5
seconds
Mains power quality should be
that of a typical commercial or
hospital environment. If the user
of the DeVilbiss DV6WM
Wireless Modem requires
continued operation during power
mains interruptions, it is
recommended that DeVilbiss
DV6WM Wireless Modem be
powered from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic eld
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic elds
should be at levels characteristic
of a typical location in a typical
commercial or hospital
environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
EN - 12 SE-DV6WM-1
EMC INFORMATION
(per IEC 60601-1-2:2007 Section 5.2.2.2)
Guidance and Manufacturer’s Declaration – Electromagnetic
Immunity
The DeVilbiss DV6WM Wireless Modem is intended for use in the electromagnetic
environment specied below. The customer or the user of the DeVilbiss DV6WM
Wireless Modem should assure that it is used in such an environment.
Immunity Test IEC 60601
test level Compliance
level Electromagnetic Environment – Guidance
Conducted RF
IEC 61000-4-6
3 Vrms
150 kHz to
80 MHz
V1 = 3 Vrms
6 Vrms on ISM
& Amateur
Bands
Portable and mobile RF communications
equipment should be separated from the
device by no less than the recommended
separation distances calculated/listed below:
D=(0.4)√
P
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to
2.5 GHz
E1 = 10 V/m D=(0.4)√
P80 to 800 MHz
D=(0.7)√
P800 MHz to 2.5 GHz
Where P is the maximum power rating in
watts and D is the recommended separation
distance in meters.
Field strengths from xed RF transmitters, as
determined by an electromagnetic site
surveya, should be less than the compliance
level in each frequency rangeb.Interference
may occur in the vicinity of equipment marked
with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reection from structures, objects and people.
a. Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to xed RF transmitters, an electromagnetic site survey should be
considered. If the measured eld strength in the location in which the DeVilbiss DV6WM
Wireless Modem is used exceeds the applicable RF compliance level above, the DeVilbiss
DV6WM Wireless Modem should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as reorienting or
relocating the DeVilbiss DV6WM Wireless Modem.
b. Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than [V1] V/m.
(per IEC 60601-1-2:2007 Section 5.2.2.2)
Recommended Separation Distances Between Portable and
Mobile RF Communications Equipment and this device. This
device and system are NOT Life-Supporting
The DeVilbiss DV6WM Wireless Modem is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of
the DeVilbiss DV6WM Wireless Modem can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications
equipment (transmitters) and the DeVilbiss DV6WM Wireless Modem as recommended
below, according to the maximum output power of the communications equipment.
Rated Maximum
Output Power of
Transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz to 80 MHz
outside ISM bands
D=(0.4)√
P
80 MHz to 800 MHz
D=(0.4)√
P
800 MHz to 2.5 GHz
D=(0.7)√
P
0.01 0.04 0.04 0.07
0.1 0.11 0.11 0.22
1 0.35 0.35 0.70
10 1.1 1.1 2.2
100 3.5 3.5 7.0
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be determined using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
NOTE 2: The ISM (industrial, scientic and medical) bands between 150 kHz and 80 MHz
are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and
40.66 MHz to 40.70 MHz.
NOTE 3: An additional factor of 10/3 has been incorporated into the formulae used in
calculating the recommended separation distance for transmitters in the ISM frequency
bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to
decrease the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into patient areas.
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reection from structures, objects and people.
EN - 13SE-DV6WM-1
EMC INFORMATION
FCC and Industry Canada Statement
GSM Module Contains FCC D: QIPEHS6; Contains IC: 7830A-EHS6
Bluetooth Module Contains FCC ID: TFB-BT1; Contains IC: 5969A-BT1
This device complies with part 15 of the FCC Rules and with Industry Canada license-exempt RSS standard(s). Operation is subject to the following two conditions: (1)
This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
The output power of this device is less than 20mW. The SAR test is not required. When using it, ensure that the antenna of the device is at least 20cm away from all
persons.
This Class B digital apparatus complies with Canadian ICES-003.
NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modications or changes to this equipment. Such modications or
changes could void the user’s authority to operate the equipment.
NOTE: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed
to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if
not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will
not occur in a particular installation. If this equipment causes harmful interference to radio or television reception, which can be determined by turning the equipment off
and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna.
- Increase the separation between the equipment and receiver.
- Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
- Consult the dealer or an experienced radio/TV technician for help.
CE Declaration
Hereby, DeVilbiss Healthcare LLC, declares that this DV6WM Wireless Modem is in compliance with the essential requirements and other relevant provisions of
Directive 1999/5/EC. The declaration of conformity may be consulted at www.devilbisshealthcare.com/les/DV6WM_CE_Declaration.pdf.
The Bluetooth® word, mark, and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by DeVilbiss is under license. Other trademarks and trade names are
those of their respective owners.
ES - 14 SE-DV6WM-1
ÍNDICE
Uso previsto ......................................................................... ES - 14
Contraindicaciones............................................................... ES - 14
Símbolos............................................................................... ES - 14
Precauciones importantes.................................................... ES - 15
Precauciones y advertencias........................................... ES - 15
Contenidos del paquete ....................................................... ES - 16
Partes importantes ............................................................... ES - 16
Configuración y funcionamiento: CPAP de la serie DV6x.... ES - 17
Configuración inicial del módem inalámbrico .................. ES - 17
Cómo funciona el módem inalámbrico ............................ ES - 18
Cómo cargar la batería del módem ..................................... ES - 19
Limpieza y mantenimiento.................................................... ES - 19
Eliminación y especificaciones............................................. ES - 20
Solución de problemas......................................................... ES - 22
Información de EMC............................................................. ES - 23
para el paciente o se puede dañar el dispositivo de CPAP. Algunas
fuentes electromagnéticas pueden no ser aparentes. Si se notan cambios
inexplicables en el funcionamiento de este dispositivo, si está emitiendo
sonidos inusuales o fuertes, desconectar el cable de suministro eléctrico
y discontinuar el uso. Comuníquese con su proveedor de atención
médica domiciliaria.
SÍMBOLOS
Botón de llamada de
prueba Fabricante
Luz LED de estado del
teléfono celular Fecha de fabricación
Luz LED de estado del
Bluetooth Símbolo de voltaje de CC
Luz LED de estado de la
batería Número de modelo
Conector del cargador de
la batería Número de serie
Consulte las Instrucciones
de funcionamiento EC REP Representante europeo
Transmisor de
radiofrecuencia
No es seguro para RM –
Peligroso para entornos de
resonancia magnética
IP21
Protección contra ingresos: protegido contra el acceso de los
dedos a las piezas peligrosas; protegido contra la caída vertical
de gotas de agua
Rx
Only
PRECAUCIÓN: La legislación federal de los EE. UU. solo
autoriza la venta de este dispositivo a médicos o por prescripción
médica.
Este dispositivo contiene un equipo eléctrico y/o electrónico que
debe reciclarse de acuerdo con la Directiva 2012/19/UE de la
Unión Europea – Equipo Eléctrico y Electrónico de Desecho
(WEEE)
USO PREVISTO
El módem inalámbrico DV6WM de DeVilbiss Healthcare está
diseñado para utilizarse como un accesorio de los dispositivos de
CPAP Serie DV6x y DV5x con el módulo SmartLink II Bluetooth
para pacientes en el hogar o en un entorno médico.
CONTRAINDICACIONES No es seguro para RM
No llevar el dispositivo ni los accesorios a un entorno de
resonancia magnética (RM), ya que puede representar un riesgo
inaceptable para el paciente o se pueden dañar el dispositivo o los
dispositivos médicos de resonancia magnética. El dispositivo y los
accesorios no fueron evaluados en cuanto a seguridad dentro de
un entorno de resonancia magnética.
No usar el dispositivo ni los accesorios en un entorno con equipos
electromagnéticos como equipos de tomografía computada,
diatermia, RFID y sistemas de seguridad electromagnéticos
(detectores de metal) ya que puede causar riesgos inaceptables
ES - 15SE-DV6WM-1
PRECAUCIONES IMPORTANTES
LEA TODAS LAS INSTRUCCIONES ANTES
DE UTILIZAR ESTE DISPOSITIVO.
GUARDE ESTAS INSTRUCCIONES.
(de acuerdo con IEC 60601-1-2:2007 Sección 5.2.2.1 b)
ADVERTENCIA: El uso de ACCESORIOS, transductores y cables
diferentes a los especicados, con excepción de los transductores
y cables vendidos por DeVilbiss Healthcare como piezas de
repuesto para los componentes internos, puede ocasionar un
aumento en las EMISIONES o una disminución de la INMUNIDAD
del EQUIPO ME o SISTEMA ME.
(de acuerdo con IEC 60601-1-2:2007 Sección 5.2.2.1 d)
ADVERTENCIA: El módem inalámbrico DV6WM de DeVilbiss no
debe utilizarse adyacente o apilado con otro equipo y en caso de
que el uso adyacente o apilado sea necesario, debe vericarse que
el Módem inalámbrico DV6WM de DeVilbiss funcione con
normalidad en la conguración en que será utilizado.
(de acuerdo con IEC 60601-1-2:2007 Sección 5.2.2.5)
ADVERTENCIA: El módem inalámbrico DV6WM de DeVilbiss puede
verse afectado por interferencias causadas por otro equipo, incluso
si este otro equipo cumple con los requisitos de EMISIONES de
CISPR.
Banda de frecuencia de BT en receptor de RF 2,402 GHz ~ 2,480 GHz
Ancho de banda de BT en receptor de RF 2,402 GHz ~ 2,480 GHz
Banda de frecuencia de GSM en receptor de RF 824,2 MHz ~ 1907,6 MHz
Ancho de banda de GSM en receptor de RF 824,2 MHz ~ 1907,6 MHz
(de acuerdo con IEC 60601-1-2:2007 Sección 5.2.2.5)
Banda de frecuencia de BT en transmisor de RF 2,402 GHz ~ 2,480 GHz
Modulación de BT GFSK, 8DPSK
Potencia Radiada Aparente de BT < -10 dBm (100 mW)
Banda de frecuencia de GSM en transmisor de RF 824,2 MHz ~ 1907,6 MHz
Modulación de GSM 8-PSK, WCDMA
Potencia Radiada Aparente de GSM < +33 dBm (2000 mW)
PRECAUCIONES Y ADVERTENCIAS
• Consulte la norma internacional IEC 60601-1 Ed 3.0 Enmienda 1
para conocer los requisitos de seguridad que se aplican a los
Sistemas Médicos Eléctricos.
• Riesgo de choque eléctrico – No intente abrir o quitar el
gabinete del cargador o el módem inalámbrico; en el interior no
hay componentes a los que el usuario pueda dar
mantenimiento. Si requiere mantenimiento, comuníquese con el
proveedor del equipo para que le brinde indicaciones a n de
obtener el servicio. Abrir o intentar reparar el dispositivo
anulará la garantía.
• No realice tareas de mantenimiento mientras el módem
inalámbrico esté en uso.
• El módem inalámbrico contiene una batería de polímero de litio
(LiPO). No la deseche junto con los residuos domiciliarios.
• El reemplazo de las baterías de litio por parte de personal
capacitado inadecuadamente puede representar un RIESGO. El
módem inalámbrico DV6WM no contiene piezas que el usuario
pueda reparar. El módem solo debe ser reparado por un
proveedor de DeVilbiss calicado.
• Si el módem inalámbrico comienza a funcionar de un modo
inusual o de algún modo que no se describe en esta guía, no
conecte el módem inalámbrico a un cargador o a ningún otro
equipo. Comuníquese con el proveedor del equipo para
informarle sobre este funcionamiento inusual.
• Si el módem inalámbrico está expuesto a condiciones de
humedad o temperaturas extremas durante el almacenamiento,
deje que el dispositivo se asiente a temperatura ambiente
durante 2 horas antes de ponerlo en funcionamiento o cargarlo.
• No conecte el módem inalámbrico DV6WM a equipos que no se
describen en estas instrucciones. La conexión del módem a
otro equipo u otros accesorios puede provocar el mal
funcionamiento o daño del módem inalámbrico DV6WM.
• No realice modicaciones en el Módem inalámbrico DV6WM o
ES - 16 SE-DV6WM-1
PARTES IMPORTANTES
Módem inalámbrico: Panel de control
Botón de llamada de prueba
Presionar para confirmar la iluminación de las luces LED
Teléfono celular (conexión
con el servidor)
Bluetooth (conexión
con CPAP) Batería Conector de carga
de batería (USB)
DV6WM-122 Rev. C
Restablecer (no presionar
excepto que así lo indique
su proveedor)
Funcionamiento normal
La luz LED de batería parpadea cuando la batería está baja. De lo contrario, todas las luces LED
permanecen APAGADAS, excepto durante la secuencia de llamada. Durante la llamada, la luz LED
de batería se ilumina ja y las luces LED de Bluetooth o del teléfono celular también permanecen
activas. Es posible que no lo perciba.
La frecuencia de la llamada ha sido predeterminada por su proveedor.
NOTA: Si la luz LED de batería parpadea, consulte la sección Cómo cargar la batería del módem.
NOTA: Para vericar el funcionamiento en cualquier momento, presione el botón de llamada de
prueba y conrme la iluminación de las luces LED.
en los accesorios, ya que esto puede
provocar el mal funcionamiento o
daño del Módem inalámbrico
DV6WM.
• Utilice solo los cargadores y cables
de cargadores provistos por
DeVilbiss para ser utilizados con el
módem inalámbrico DV6WM. El uso
de otros cargadores o cables de
cargadores puede provocar el mal
funcionamiento o daño del módem
inalámbrico DV6WM.
Almacenamiento y manipulación: Las
condiciones que se describen a
continuación pueden provocar riesgo
de incendio, si se produce una falla en
la batería interna recargable.
• Nunca intente cargar un módem
inalámbrico que presente daño
físico.
• Si la temperatura del módem
inalámbrico supera los 50 ˚C (122
˚F), dé por nalizada la carga.
• No exponga el módem inalámbrico
al calor ni lo arroje al fuego.
• No utilice ni almacene el módem
inalámbrico cerca del fuego o
dentro de un automóvil donde la
temperatura pueda superar los 60
˚C.
• No sumerja el módem inalámbrico
en agua.
PRECAUCIONES Y
ADVERTENCIAS
Módem inalámbrico
DV6WM
Cargador
USB de pared Guía de
instrucciones
CONTENIDOS DEL PAQUETE
ES - 17SE-DV6WM-1
Configuración y funcionamiento: CPAP de la serie DV6x
Configuración inicial del módem inalámbrico
NOTA: Cargue por completo la batería antes de comenzar la
conguración. Consulte la sección Cómo cargar la batería del
módem.
2. Presione el botón de
Llamada de prueba del
Módem inalámbrico
a. Todas las luces LED se
iluminarán durante 1
segundo
aproximadamente y
luego se APAGARÁN
b. La luz LED de batería
muestra el estado de la
batería
c. La luz LED de Bluetooth
comenzará a parpadear
lentamente mientras
busca la unidad de
CPAP
3. Vincúlelo con CPAP de la Serie
DV6x
a. La luz LED de bluetooth del
módem comenzará a
parpadear rápido cuando esté
listo para vincular con CPAP
(aproximadamente 30
segundos hasta que comience
el parpadeo rápido).
b. El número de serie del módem
inalámbrico deberá aparecer
en la lista cuando la CPAP
realice la búsqueda.
NOTA: Espere hasta que el
Módem aparezca en la lista, esto
puede demorar 30 segundos.
c. En la pantalla “Hacer clic en
el elemento para vincular”,
seleccione el número de serie
del Módem inalámbrico y
presione, el menú mostrará
“Vinculando…” y luego “Listo”.
d. La luz LED de Bluetooth del
módem inalámbrico dejará de
parpadear y se mantendrá
ENCENDIDA mientras lee
datos de la unidad CPAP.
DV6WM 122 Rev C
DV6WM 122 Rev C
PRESS
DV6WM 122 Rev C
1. Verique la unidad de
CPAP de la serie DV6X
para asegurarse de que el
Bluetooth está
ENCENDIDO
a. Desplácese hacia los
COMPLEMENTOS
b. Seleccione Bluetooth
c. Presione para alternar
de APAGADO a
ENCENDIDO, si es
necesario
PRESS
DV6WM 122 Rev C
4. La luz LED del teléfono celular en
el módem parpadeará y luego
quedará ja durante algunos
minutos.
PRESS
ES - 18 SE-DV6WM-1
Configuración y funcionamiento: CPAP de la serie DV6x
Para ver la información sobre el módem, seleccione
Módem inalámbrico en el menú COMPLEMENTOS del
CPAP DV6x y presione.
Información que se muestra en la pantalla de CPAP DV6x sobre el módem inalámbrico
Días transcurridos desde la última carga al servidor
ID del módem inalámbrico
Señal de Bluetooth
Señal de teléfono celular
Nivel de batería
PRESS
El módem inalámbrico de DeVilbiss funciona sin interacción en tanto el nivel de la batería sea
suciente.
Cómo funciona el módem inalámbrico con la unidad de CPAP de
la Serie DV6x
NOTA: La unidad CPAP de la Serie DV6x proporcionará datos sobre el
bajo nivel de batería del módem.
Cuando vea este mensaje, consulte la sección Cómo cargar la batería
del módem. El mensaje de batería baja aparece cuando se
ENCIENDE el ventilador.
DV6WM 122 Rev C
5. Encuentre una ubicación donde la luz
LED del teléfono celular quede
ENCENDIDA (no intermitente) y
coloque el módem donde no sea
alterado.
NOTA: Las luces LED del Bluetooth y
del teléfono celular permanecerán
APAGADAS en condición normal. Solo
aparecerán encendidas si el módem
está intercambiando datos con la unidad
de CPAP o con el servidor. Es posible
que no lo perciba. Ignore el módem.
DV6WM 122 Rev C
6. Una vez que naliza la secuencia
de llamada, todas las luces LED se
APAGARÁN.
Configuración inicial del
módem inalámbrico
ES - 19SE-DV6WM-1
CÓMO CARGAR LA BATERÍA DEL MÓDEM
La luz LED de batería parpadeará 3 veces en 1 segundo cada 3 segundos
cuando el nivel de batería sea bajo. Si la luz LED de batería parpadea,
enchufe el Cargador USB de pared provisto en el módem y luego en el
tomacorriente.
La luz LED de batería en el módem:
• Parpadeará lentamente cuando la batería esté cargándose
• Estará ja cuando la batería esté cargada por completo y conectada a
la fuente de alimentación
NOTA: Si lo desea, puede mantener enchufado el módem en todo
momento.
El módem inalámbrico DV6WM funciona normalmente mientras la batería
se está cargando. El módem puede dejarse enchufado en el cargador
durante un período de tiempo más prolongado.
El tiempo de funcionamiento típico del módem inalámbrico DV6WM con
una carga de batería completa es de 90 días.
DV6WM 122 Rev C
Cargador
USB de
pared
Tomacorriente
Cuando el nivel de batería es bajo,
la luz LED de batería en el módem
parpadeará. Consulte la sección
Cómo cargar la batería del
módem.
DV6WM 122 Rev C
parpadea cuando el nivel de batería es bajo
INSTRUCCIONES DE LIMPIEZA
Instrucciones de limpieza
1. Limpie el módem una vez al mes. Desenchufe el módem
inalámbrico del cargador y limpie la supercie exterior con
un paño húmedo.
2. Almacene el módem inalámbrico en un lugar seco a
temperatura ambiente cuando no se utilice.
Para uso de varios pacientes
Si el dispositivo es para uso de varios pacientes en un entorno
de atención médica o de un programa de alquiler de
dispositivos, se debe limpiar y desinfectar el exterior del
dispositivo entre un paciente y otro.
Limpieza para uso de varios pacientes
ADVERTENCIA
Si se está usando el dispositivo en varios pacientes, se
deben realizar los siguientes pasos para limpiar el exterior
del dispositivo solamente antes de cada usuario nuevo..
1. Desconectar el aparato antes de limpiarlo.
2. Usar un paño con una solución de detergente suave (ej.
detergente líquido para lavar los platos Dawn) y agua para
retirar cualquier suciedad, si fuera necesario.
3. Usar un paño con una dilución de 1:10 de 5.25 %–6.15 %
de hipoclorito de sodio (es decir, lejía o blanqueador para
uso doméstico) para limpiar el exterior del dispositivo.
4. Asegurarse de que el dispositivo esté completamente seco
antes de enchufar el cable de suministro eléctrico.
MANTENIMIENTO
ADVERTENCIA
Riesgo de choque eléctrico – No intente abrir o quitar el
gabinete del cargador o el módem inalámbrico; en el interi-
or no hay componentes a los que el usuario pueda dar
ES - 20 SE-DV6WM-1
mantenimiento. Si requiere mantenimiento, comuníquese con el
proveedor del equipo para que le brinde indicaciones a fin de
obtener el servicio. Abrir o intentar reparar el dispositivo anulará
la garantía.
El módem inalámbrico y los accesorios no requieren mantenimiento
durante la vida útil esperada.
VIDA ÚTIL ESPERADA
• Módem inalámbrico DV6WM - 5 años
• Cargador USB de pared de CA a CC- 2 años
ELIMINACIÓN
PRECAUCIÓN: El módem inalámbrico contiene una batería de
polímero de litio (LiPO). No la deseche junto con los residuos
domiciliarios.
El módem inalámbrico y el cargador contienen residuos electrónicos.
Comuníquese con las autoridades locales para determinar un método
adecuado de eliminación de las piezas electrónicas, las piezas de
plástico y la batería de LiPO.
ACOPLAMIENTO DE DATOS/RED
• La conexión del módem inalámbrico DV6WM a un acoplamiento
de datos/red que incluya a otros equipos podría generar riesgos no
identicados previamente para los pacientes y los operadores, y la
organización responsable debe identicar, analizar y controlar esos
riesgos.
• Las modicaciones posteriores al acoplamiento de datos/red
pueden plantear nuevos riesgos y requerir un nuevo análisis.
Los cambios en el acoplamiento de datos/red incluyen lo siguiente:
• los cambios en la conguración del acoplamiento de datos/
red,
• la conexión de elementos adicionales al acoplamiento de
datos/red,
• la desconexión de elementos del acoplamiento de datos/red,
• la actualización del equipo conectado al acoplamiento de
datos/red,
• el cambio a la versión superior del equipo conectado al
acoplamiento de datos/red.
ESPECIFICACIONES
Tamaño................................................................................................................................... 11,2 cm (4,4 in) Alt. x 7,6 cm (3 in) A x 2,5 cm (1 in) Prof.
Peso ...................................................................................................................................................................................................0,35 libras (158,8 g)
Requisitos eléctricos para CA........................ 100 – 240 V CA, 50/60 Hz, 120 mA (Entrada para el cargador USB de CA a CC externa especificada)
Requisitos eléctricos para CC......................................... 4,74 – 5,25 V CC, 500 mA (Salida para el cargador USB de CA a CC externa especificada)
Consumo máximo de energía............................................................................................................................. 3 vatios del cargador USB de CA a CC
Rango de temperatura de funcionamiento............................................................................................................... De 41 ˚F a 104 ˚F (de 5 ˚C a 40 ˚C)
Rango de humedad de funcionamiento .....................................................................................................................15 % a 95 % HR sin condensación
Condiciones atmosféricas de funcionamiento........................ 700 hPa a 1060 hPa (~9800 pies [2987 m] a ~ 1400 pies [426 m] bajo el nivel del mar)
Rango de temperatura de almacenamiento y transporte..................................................................................De 13 ˚F a +158 ˚F (de -25 ˚C a +70 ˚C)
Rango de humedad de almacenamiento y transporte.................................................................................................0 % a 95 % HR sin condensación
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