Technical Guide

Declaration of Conformity Notice

T This medical equipment complies with the Medical Device

Directive, 93/42/EEC, and the following technicalstandards, to
which conformity is declared:

IEC 601-1
IEC 601-1-2
ISO 9001
EN 46001
MDD-ANNEX II
NOTIFIED BODY: SEMKO

Type of Equipment: Nasal CPAP System

Trade name: Silenzio, Silenzio Plus, Silenzio Delta
Model No.: 3351-00000 3361-00000 3331-00000

If you have any questions reguarding the Declaration of Conformity

for this product, please contact Nidek Medical Products, Inc.

World Headquarters Latin American

Nidek Medical Products, Inc. Nidek Medical Products, Inc.
3949 Valley East Ind. Drive Latin America & Caribbean
Birmingham, Al 35217-1838 Regional Office
U.S.A. 9836 SW 117th Place
Phone: (205) 856-7200 Miami, Fl 33186
Fax: (205) 856-0533 Phone: (305) 270-0260
Fax: (305) 270-9593

EU Representative
mdi Europa Gmbh
Wittekemp 30
D-30163 Hannover, Germany
Phone: +49-511-39 08 95 30
Fax: +49-511-39 08 95 30
e-mail: info@mdieruropa.com
www.mdieuropa.com

Technical Guide July 2003 2

TABLE OF CONTENTS

Silenzio, Silenzio Plus and Silenzio Delta

Technical Guide
OPERATOR’S GUIDE

Declaration of Conformity.................................................................... 2

Introduction ............................................................................................ 4

Equipment Symbols............................................................................... 5

Important Safeguards........................................................................ 6 ,7

Unpacking Your Silenzio....................................................................... 8

Buttons And Functions.......................................................................... 9

Operating Instructions ...................................................................10, 11

Cleaning And Disinfecting ................................................................. 12

Maintenance.......................................................................................... 13

Troubleshooting.................................................................................... 14

Specifications ........................................................................................ 15

TECHNICAL GUIDE

Description Of Silenzio ....................................................................... 16

Description Of CD 100 Remote Control ........................................... 17

Pressure And Ramp Adjustments................................................ 18, 19

Supplemental Oxygen ......................................................................... 20

Principle Of Operation ........................................................................ 20

Installation/Maintenance Checklist.................................................. 21

Warranty................................................................................................ 22
Technical Guide July 2003 3
INTRODUCTION

Silenzio is a lightweight, quiet and compact device used to treat

Obstructive Sleep Apnea (OSA).

Obstructive Sleep Apnea (OSA) is a condition in which a person’s airways

become obstructed during sleep. The obstruction causes a temporary
suspension of breathing, which may cause the patient to awake many times
throughout a night, disturbing necessary sleep patterns.

Silenzio treats OSA by providing a positive pressure of air to the patient

through a mask the patient wears while sleeping. This
continuous positive airway pressure (CPAP) keeps
the patient’s airways open.

Silenzio is not a continuous breathing device.

It is not capable of restoring or sustaining
life. Silenzio is intended for spontaneously
breathing adults only, i.e., adults who can
breathe normally on their own during waking
hours. It is to be used only under the advice of
a physician.

Silenzio is safe, easy to use and equipped

with a built-in universal power supply
which automatically adapts to any voltage
throughout the world.

To make sure Silenzio gives years of

trouble-free operation, please take
time to carefully read the IMPORTANT
SAFEGUARDS section on the
following pages.

Technical Guide July 2003 4

Equipment Symbols

The following symbols appear on the Silenzio Nasal CPAP system.

Symbol Compliance Meaning

IEC 878 This symbol indicates ATTENTION, consult the

Symbol #03-02 ACCOMPANYING DOCUMENTS.

IEC 417 This symbol indicates Class II equipment.

Symbol #5172

IEC 878 This symbol indicates the “ON” condition and connects the
equipment from the MAINS supply.

IEC 878 This symbol indicates the OFF condition and disconnects the
equipment from the MAINS supply.

~
IEC 878 This symbol indicates TYPE BF equipment.

IEC 878 This symbol indicates equipment suitable for alternating current.
Symbol #01-14

EPAP Symbol Expiratory Pressure

IPAP Symbol Inspiratory Pressure

Symbol Indicates conformity with the directive 93/42/CEE certified by the

notified body no. 0413.

C-H Symbol Hour Meter Status; Compliance Hours - Total Hours.

Symbol Progressive rise in pressure (pressure ramp).

Symbol Progressive rise in pressure reset to zero.

Reset

Symbol When lit, pressure = set pressure.

Freq. (c/min) Symbol Minimum Respiratory Frequency.

Technical Guide July 2003 5

IMPORTANT SAFEGUARDS

AVOID RISK of ELECTRIC SHOCK - Always unplug Silenzio before cleaning

it. Avoid overloading wall outlets and extension cords, which creates a fire
hazard and risks electric shock.

CONNECTIONS - Turn Silenzio OFF before connecting or disconnecting any

attachments or accessories. Turn Silenzio OFF before unplugging.

HEAT, SPARKS and FLAMES - Keep Silenzio away from any source of
sparks or heat. If your doctor has prescribed supplementary oxygen, be
aware that, while oxygen is not combustible, it activates the combustion of
flammable material. Keep ignitable materials away from the equipment and
oxygen tubes. Keep Silenzio at least 6 feet from any flame, such as stove,
water heater, fireplace, etc.

SMOKING - Discourage smoking in the room where Silenzio is being used.

WATER and MOISTURE - Avoid placing containers of liquid on top of

Silenzio. Spilled liquid can result in electrical shock. Do not immerse
Silenzio into water or any other liquid. Do not place Silenzio where it can
fall into water, such as near a bathtub, toilet, sink, wash bowl, laundry tub,
swimming pool, etc. Do not touch Silenzio if it has fallen into water! Unplug
it immediately. Do not use Silenzio in a room with a high moisture content,
such as a wet basement. To properly clean Silenzio, refer to the CLEANING
and DISINFECTING section of this Owner’s Guide.

SOLVENTS - Do not spray aerosols near Silenzio, even if the unit is off.
Do not open containers of solvents such as mineral spirits or alcohol while
Silenzio is being used.

Technical Guide July 2003 6

IMPORTANT SAFEGUARDS

CONTROLS and SETTINGS - Never try to adjust Silenzio. Settings are fixed
according to medical prescription. Only a doctor or respiratory therapist is
authorized to adjust Silenzio controls and settings.

EXTREME TEMPERATURES - During transport, storage or use, avoid submitting

Silenzio to high or low temperatures. Silenzio should be at room temperature
before switching ON. The air flow produced by Silenzio for breathing can be
as much as 100F higher than the temperature of the room. Caution should be
exercised if the room temperature is warmer than 900F.

SERVICE - Never remove Silenzio’s protective cover. Do not grease or oil any
part of Silenzio. If Silenzio does not operate normally, or if the power cord
or plug has damage, refer servicing to your Silenzio dealer or Authorized
Nidek Medical Repair Center.

TRANSPORT - Place Silenzio in its carrying case before transporting. If

travelling by air, carry Silenzio as personal luggage. Never allow Silenzio to
be handled as general luggage.

VENTILATION - Allow good circulation of air around Silenzio. Do not place

Silenzio against a wall or curtain or on a bed, blanket, sofa or other similar
surfaces. Do not operate Silenzio in a closed space such as a drawer, or
built-in bookcase.

Technical Guide July 2003 7

 UNPACKING YOUR SILENZIO

CONTENTS As you unpack your SILENZIO, please make sure the following items are
included:

SILENZIO and SILENZIO PLUS

• 1- 6 ft. corrugated Patient Circuit Tube with connector
• Carrying Case

SILENZIO DELTA
• 1- 6 ft. corrugated Patient Circuit Tube with connector
• 1- Pressure Sensing Tube
• Carrying Case

ACCESSORIES Various accessories are available for use with Silenzio.

They include:

• Mask (with connector) (required)

• Headgear (required)
• Supplemental Oxygen Administration Kit . (Part #9003-1901)
• Replacement Air Filters ................................ (Part #9003-6637)
• Optional Electrostatic Filters ......................... (Part #9003-6638)
• DC to AC Converter......................................... (Part #9003-1900)
• Humidification Starter Kit System ................ (Part #9003-1910)
• Humidification Heater Base ...........................(Part #9003-1911)
• Humidification Administration Kit .............. (Part #9003-1902)
ACCESSORIES

Important: Silenzio should only be used with masks (and connectors),

headgears, supplemental oxygen kits and air filters recommended by the
manufacturer of Silenzio, or by your physician or respiratory therapist.

Technical Guide July 2003 8

BUTTONS AND FUNCTIONS

FRONT

 Patient’s Ramp Reset Button

 Pressure Leakage Indicator

 Patient Circuit Connection

 Patient Pressure Sensing

Connection (Delta Model Only)

REAR

 Air Filter
  On(i)/Off(0) Switch
 Power Cord

Technical Guide July 2003 9

 OPERATING INSTRUCTIONS

The following instructions use numbers as well as names to help you find
buttons and features on your Silenzio unit. For example, to locate numbered
items ,  or  on your Silenzio, refer to the BUTTONS and FUNCTIONS
section of this Owner’s Guide .

SETTING UP 1. Place Silenzio in a well-ventilated area, away from walls, curtains, blankets,
etc. Be sure the air filter , on the rear of Silenzio, is not blocked.
2. Make sure Silenzio is unplugged. Turn the On/Off switch  to the OFF
(0) position before making connections.
3. Insert the Patient Circuit connector into the large Patient Circuit Connection
 on the front of Silenzio.
4. (For Delta Model Only) Attach the smaller tube, which leads from the Patient
Circuit connector, to the Patient Sensing Connector  on the front of Silenzio. Turn
the Patient Circuit connector so that the smaller tube is not kinked or pinched.
((Delta Model Only)
5. Connect your mask to the opposite end of the Patient Circuit until it is
secure. Use only a mask (and connector) recommended by the manufacturer
of Silenzio, your physician or therapist.

GETTING 6. Fit your headgear on your head and the mask over your nose. A tight fit
STARTED is not necessary. If your mask has been properly fitted, the size and style
should provide a comfortable fit and efficient air seal.
7. With Silenzio OFF (0), plug Silenzio’s power cord  into your electrical outlet.
8. Turn Silenzio ON (I) .
9. Take your time to get used to the air pressure felt in the mask. With your
mouth closed, take a few deep breaths to help you adjust to breathing against
the air pressure.
10. Your mask, and/or connector, will have at least one vent hole to allow
your exhaled (CO²) to escape. Be sure the vent hole(s) are not blocked.

Silenzio Models Only 11a. With the mask and the headgear in place, check the Pressure Leakage
Indicator . A green light indicates there are no significant leaks in the mask,
Patient Circuit or connections. If the Pressure Leakage Indicator  does not
show green, adjust your mask and/or headgear until the green light illuminates.
Silenzio will now provide the appropriate prescription pressure.

Silenzio Delta and 11b. With the mask and the headgear in place,hold down the Patient Ramp
Plus Models Only Reset Button and check the Pressure Leakage Indicator . A green light indi-
cates there are no significant leaks in the mask, Patient Circuit or connections.
Release the Patient’s Ramp Reset Button. If the Pressure Leakage Indicator 
does not show green, adjust your mask and/or headgear until the green light
illuminates. Silenzio will now provide the appropriate prescription pressure.
continued
Technical Guide July 2003 10
OPERATING INSTRUCTIONS

12. Your doctor or respiratory therapist may set the Ramp Selection Control to
provide more comfort during the time before you fall asleep. If so, the pressure
will gradually build to the prescribed pressure over the time period set on the
Ramp Control. (Silenzio Model) - to activate the ramp you must press the Patient
Ramp Reset Button  on the front of Silenzio. (Silenzio Plus and Silenzio Delta
Model) - unit will automatically ramp if ramp is set and unit is turned on.
13. If you take longer than usual to fall asleep, or if you wake up in the night
and wish to restart the ramp phase, press and release the Patient Ramp Reset
Button  on the front of Silenzio.

SAFE 14. Your doctor will have prescribed a Silenzio pressure setting specific to
SETTINGS your needs. Silenzio is designed to help you get a good night’s sleep. If you
have a problem obtaining comfort using Silenzio, consult your doctor.
15. If your doctor has prescribed supplemental oxygen for use with Silenzio,
follow the doctor’s or therapist’s instructions.

WHEN YOU 16. Before turning Silenzio OFF (0), remove your mask and headgear and, if
HAVE you are using supplemental oxygen, turn the oxygen source OFF.
FINISHED

Warning: Never use your mask while Silenzio is turned OFF (0). Silenzio
must be ON (I) and operating properly to provide new air to flush the air you
exhale (CO² ) out of the mask through the vent hole(s). If Silenzio is OFF (0),
is operating improperly or is operated at low pressure, CO² may accumulate in
the mask and circuit tubing. Breathing CO² for several minutes can, in some
circumstances, lead to suffocation.

Warning: A supplemental oxygen source, if one is used, must always

be turned OFF when Silenzio is OFF (0). If oxygen is left on while Silenzio
is not operating, oxygen may accumulate in the mask or mask connector
and create a risk of fire.

TURNING 17. After you have removed the mask and turned OFF your oxygen (if used),
SILENZIO turn Silenzio OFF (0).
OFF
18. Unplug Silenzio before detaching Patient Circuit, mask and oxygen tubing.
19. Refer to daily cleaning instructions in the CLEANING and DISINFECTING
section of this Owner’s Guide.

Technical Guide July 2003 11

 CLEANING AND DISINFECTING

Regular cleaning is important for the proper operation of Silenzio. All

cleaning and disinfecting can be done by the patient.
Always take the following steps and precautions before cleaning Silenzio
BEFORE parts and accessories:
CLEANING
1. Turn OFF (0) Silenzio.

2. Clean the mask by wiping the inside and outside of the mask with a soft cloth
DAILY
(After each use) and warm soapy water. Carefully rinse the mask with clean water and dry with
a dry cloth. Store mask in a dry, dust-free environment when not in use.

3. Remove the air filter  from the rear of the Silenzio unit. Wash the air filter
WEEKLY with warm, soapy water, rinse in running water and allow to completely dry
before replacing it on your Silenzio unit.

4. Unplug Silenzio.

5. To clean your Silenzio unit, wipe it with a clean, soft cloth dampened with
warm, soapy water. Then, wipe the unit with a cloth moistened only with water.
Allow Silenzio to completely dry before plugging in the Power Cord  .

IMPORTANT Never immerse your Silenzio unit in water! Take special care to prevent moisture from
entering the unit.

6. To clean the Patient Circuit, remove the connector from the Patient Circuit.
(Delta Model Only) Then remove the smaller tubing (pressure sensing tube)
found inside the Patient Circuit. Immerse only the Patient Circuit in warm,
soapy water. Use a disinfecting solution on the Patient Circuit, if necessary.
Rinse the Patient Circuit thoroughly in clean water.

7. Allow the Patient Circuit to completely dry before reassembling.

CAUTION Do not use abrasive powders or solvents, such as alcohol or acetone, to clean Silenzio
parts or accessories.

Technical Guide July 2003 12

 MAINTENANCE

 Silenzio operates without the need for outside service, maintenance or repair,
provided that you follow all safety, operating, and maintenance instructions.
Please retain this Owner’s Guide for future reference. The maintenance
recommendations listed below are for your convenience.

FILTER REPLACEMENT

It is recommended that you replace the Air Filter  on the rear of the Silenzio
at least every 6 months. Obtain replacement filters from your Silenzio
dealer.

 MASK REPLACEMENT
Replace the mask when it begins to lose its flexibility or shows excessive
wear.

 ANNUAL INSPECTIONS
Have your physician, respiratory therapist or Silenzio dealer check your unit
once a year to ensure proper operation.

Date Time Meter Reading Filter Replacements Mask Replacements Pressure Setting
Inspections

PHYSICIAN INFORMATION SILENZIO DEALER INFORMATION

Physician: _____________________ Dealer: ___________________________
Telephone: ____________________ Contact: __________________________
Prescription: ___________________ Telephone: _______________________
______________________________
Technical Guide July 2003 13
TROUBLE SHOOTING

Problem Probable Cause Possible Solution

Unit will not function • No power. • Check power cord.

with the switch in the • Check wall outlet.
ON (I) position.

Will not supply a flow • Blower fault. • Contact Silenzio dealer.

of air. •Blocked sensing tube. • Check sensing tube
(Delta Model Only) (Delta Model Only)
• Electronic fault. • Contact Silenzio dealer.

The blower is revolving • Excessive leak in Patient •Check connections and

at maximum speed. Circuit. seal of mask.
•Unconnected Sensing • Check connections.
tube. (Delta Model Only)
• Electronic fault. • Contact Silenzio dealer.

Unit will not supply the •Ramp is activated. • Wear mask. Wait for
prescribed pressure. full pressure build-up
or press and hold
down the Patient
Ramp Reset Button on
the front of the unit to
verify pressure.
• Air filter is blocked. • Check that air filter is
in place and clean.
• Faulty operation. • Contact Silenzio dealer.
• Incorrect pressure setting. • Contact Silenzio dealer.

Technical Guide July 2003 14

 SPECIFICATIONS

PRINCIPLE OF MAINTENANCE RECORD

OPERATION Silenzio’s primary component is a turbine blower driven by a brushless
DC electric motor. The speed of the motor varies depending upon voltage
applied. An electronic device regulates the speed of the motor according to
the amount of pressure required in the Patient Circuit.

SAFETY Silenzio is manufactured to respect international standards defining double

insulation characteristics, and is protected by a fuse. In the unlikely event
of a failure in the command electronics, Silenzio will be unable to deliver
pressure greater than 22 cm H2O.

SPECIFICATIONS Automatic Universal Power Supply

90-250 V ~ 50/60 Hz
Fuse 3.2 AMP
80 VA maximum
Insulation Class II (double insulated)

Noise Level
< 32 dBA at 1 meter with a setting of 10 cm H2O pressure (mask sealed).

Dimensions
6.6”H x 7.3”W x 10.3”D
16.8 cm H x 18.5 cm W x 26.2 cm D

Weight
6 lbs.
2.7kg.

Manufacturer will send, upon request, wiring diagrams, component lists,

MORE
INFORMATION or other technical information which may be useful to an authorized
technician repairing parts of Silenzio that the manufacturer has designated
as being repairable.

Technical Guide July 2003 15

 DESCRIPTION

FRONT
 Patient’s Ramp Reset Button
 Pressure Leakage Indicator
(Green LED-pressure = to set
 pressure)

  Patient Circuit Connection


 Patient Pressure Sensing
Connection (Delta Model Only)

  Transport Handle

REAR
 Air Filter
  On(I)/Off(0) Switch

 Power Cord
 
 CD 100 Remote Control Port

BOTTOM

13
10
11 15
10 Ramp Selection Control
12 (0-37 min.) (timing selection in
4 minute increments)
11 CPAP/EPAP Adjustment
12 Time Meter Switch
14 (Delta Model Only)
C: Compliance - operational
Note: Silenzio Delta’s Breath Rate Support dial is not only when pressure = to set
shown on this illustration. pressure
H: Hour Meter - operational
when unit is switched on(i)
13 Time Meter
14 Adjustment Tool
15 IPAP Adjustment (For use
with Silenzio Plus & Delta Model)

Technical Guide July 2003 16

DESCRIPTION CD 100 REMOTE CONTROL

FRONT
15 CD 100 Remote Connection
16 Analog Output Connection
1. Pressure Signal 0.1V/cmH20
2. 0V
3. +12V
17 Alternate Control Button
(located on side panel)
18 CPAP/EPAP Adjustment
(4 to 18 cmH20)
19 Pressure Reading Display
20 IPAP Adjustment
(For use with Silenzio Plus & Delta
Models)
18 17 21 Frequency
Breath Rate Support
(For use of Delta Model Only)

Technical Guide July 2003 17

 PRESSURE SETTING ADJUSTMENTS

The following instructions are intended for clinicians who are preparing the Silenzio for use on a patient.
Adjusting Silenzio is required when placed into service for the first time and when a patient’s prescription
changes, or when verifying proper pressure settings.

1. Verify the pressure-measuring device is calibrated and accurate. Many pressure measuring
devices maybe used, such as water manometer, digital manometer or pressure gauge.

2. Attach one end of the patient tubing to Silenzio. Attach the other end to the pressure setting con-
nector. Connect a small tube from pressure setting connector to manometer or gauge. (Pressure Setting
Kit Part Number 9003-1837). Pressure setting kit maybe substituted with nasal CPAP mask with a pres-
sure port.

3. To access to Silenzio pressure and ramp controls, place the Silenzio unit on its side and remove the
small foam cover (if previously attached) from bottom of device.

4. Using adjustment tool attached to Silenzio or a small screwdriver, set Ramp Delay Selection
Control to zero.

5. Turn power ON (i) to Silenzio and manometer or Gauge, if required.

6. Verify air leak from end of pressure setting connector. Turn CPAP/EPAP pressure adjustment while
observing manometer or gauge. Turn adjustment clockwise to increase pressure and counter clockwise
to decrease pressure. Adjust pressure until desired pressure is observed on manometer or gauge.

If adjusting Silenzio CPAP model only proceed to step 10.

Additional Settings for Silenzio Plus and Silenzio Delta

7. Complete steps 1 through 6 for EPAP adjustment

8. Place finger over the outlet port of pressure setting connector briefly and release. This action trig-
gers the Silenzio Plus or Delta into inspiration mode. Turn IPAP pressure adjustment while observing
manometer or gauge. Repeat this step until desired pressure is observed.

NOTE: There is a 10cm H2O maximum differential between EPAP and IPAP on Silenzio Plus only.
There is no maximum defined differential between EPAP and IPAP for Silenzio Delta.

If adjusting Silenzio Plus Bi-Level only proceed to step 10.

Technical Guide July 2003 18

 PRESSURE SETTING ADJUSTMENTS (continued)

Breath Rate Support Setting for Silenzio Delta

9. Use the adjustment tool, set Breath Rate Support to desired rate. To verify, turn the device off then on
again. This will activate Breath Rate Support. Based on the rate setting, the device will automatically
switch from EPAP to IPAP pressure and continue this cycle.

Ramp Delay Selection Control (for all models)

10. Now the device has been set to the desired pressure(s) and breath rate support (Delta only). Adjust
the Ramp Selection Control to the desired delay time.

11. Replace the foam cover from step 3. If new device, remove adhesive backing from foam cover and
place over setting controls. You have now completed the set up of the Silenzio device.

Should you require further assistance, please contact Technical Services at (800) 822-9255.

CD 100 Clinical Remote Control

Nidek Medical offers an optional CD 100 Clinical Remote Control unit for
use with the Silenzio CPAP, Silenzio Plus and Silenzio Delta models.

When the CD 100 CRC unit is connected, all functions are controlled via
the CD 100 CRC. If the Alternative Control Button located on the side of
the CD 100 CRC is depressed, the device functions are controlled via the
controls located on the bottom of the device itself.

The CD 100 CRC unit utilizes the pressure transducer located inside
the Silenzio for displaying pressure and should be verified against a
Water Column Manometer.

The CD 100 CRC unit can be used to adjust all functions of a Silenzio
device including, CPAP/EPAP, IPAP, and Breath Rate Support.

Each CD 100 CRC unit is available with a full range of cable lengths
from 25 to 100 feet. Custom lengths are available, if required. Each
unit also provides connection for an analog pressure signal.

Technical Guide July 2003 19

 SUPPLEMENTAL OXYGEN

If the doctor has prescribed the use of supplemental oxygen, connect the optional Oxygen Administration
Kit (Part #9003-1901) and follow the enclosed instructions.

Warning: If oxygen is used with a CPAP device, the oxygen source must be turned OFF when the device
is not operating.

Explanation of Warning: When the CPAP device is not in operation, and oxygen flow is left ON, the oxygen
delivered into the mask or connector may accumulate within the CPAP device. Oxygen accumulated in
the CPAP device will create a risk of fire. This warning applies to most types of CPAP devices.

Warning: At a fixed flow rate of supplemental oxygen, the inhaled oxygen concentration will vary,
depending on the pressure setting, patient breathing pattern, mask selection, and leak rate. This warning
applies to most CPAP devices.

On request, we will provide measured alveolar oxygen concentration with various tidal volumes, breaths
per minute, CPAP pressure and oxygen flow rates.

PRINCIPLE OF OPERATION

The Silenzio is essentially made of a turbine driven by a DC electric motor, the speed of which can vary
as a function of the voltage applied to its terminals. An electric motor control unit regulates the speed as
a function of the value of the pressure measured in the patient circuit, in order to keep to the set value.

On request, we can make available the circuit diagrams, lists of components, descriptions or any other
useful information to qualified technical personnel for diagnostic assistance.

Technical Guide July 2003 20

 INSTALLATION / MAINTENANCE CHECKLIST

 Connect the patient circuit to the Patient Circuit Connection

Connect Silenzio to an electrical outlet


 If use of oxygen is prescribed, connect the oxygen outlet to the mask or patient connection and
check the oxygen flow

 Switch the Silenzio ON (I)

 Check that the air filter located on the rear of Silenzio is not obstructed

 Connect the Digital or Water Column Manometer (Ref: Pressure & Ramp Adjustments) and check
that actual pressure equals the prescribed pressure

 Re-check the pressures after a minimal running time of 5 minutes

 Verify that all settings correspond to the prescription

 Check presence and good general condition of necessary accessories

Preventative Maintenance of Silenzio must be performed on a once yearly basis according to the manufac-
turer’s instructions given in the Maintenance Checklist and any updates.

Silenzio S/N: __________________ Put into Service On: _______________________

YEAR DATE HOURS MAINTENANCE BY NOTES

1st

2nd

3rd

4th

5th

6th

7th

8th

Technical Guide July 2003 21

NOTES

Technical Guide July 2003 22

NOTES

Technical Guide July 2003 23

 Silenzio
Nidek Medical Products, Inc. warrants to the original dealer-purchaser of a Nidek Medical Silenzio
that it shall: 1) Conform to Nidek Medical’s specifications, subject to ANSI tolerances, at the time
of manufacture and 2) be free of defects in material and workmanship for a period of three (3)
years on Silenzio, (2) years on Silenzio Plus and (1) year on Silenzio Delta.

To make a claim under this warranty, the Purchaser must: 1) Give Nidek Medical written notice of
the breach of warranty, within ten (10) days after discovery of such breach, 2) immediately upon
discovery of the claimed breach discontinue all use of the Silenzio; and 3) upon the request of
Nidek Medical, return the Silenzio or the applicable component part, freight prepaid, to Nidek
Medical’s plant of manufacture or such other location as designated by Nidek Medical. If it is
determined by Nidek Medical that the Silenzio or the applicable component is in breach of war-
ranty, Nidek Medical, at its option, will repair or replace it without charge.

The cost of returning the Silenzio or component part to the Purchaser after repair or replacement
will be paid by Nidek Medical. If, however, any Silenzio or component part returned by the Pur-
chaser because of an alleged breech of warranty is found by Nidek Medical not to be in breach
of warranty, then the Silenzio or component part will be returned to the Purchaser, shipping
charges collect, and the Purchaser agrees to pay a service charge to Nidek Medical to cover the
cost of handling and testing the Silenzio or component part. Dealer labor costs for removal and
replacement of parts under warranty are not covered and are the responsibility of the dealer.

This warranty is void if the Silenzio or any component part thereof has been damaged by accident,
abuse, misuse, neglect, alteration, improper service, repair by other than authorized personnel
or other causes not arising out of defects in material or workmanship. Wear of components in
normal operation, and failures resulting therefrom as determined by Nidek Medical, are excluded
from this warranty.

This warranty is not assignable by the Purchaser.

NIDEK MEDICAL MAKES NO OTHER WARRANTIES OF ANY KIND WHATSOEVER, EXPRESSED

OR IMPLIED, WITH RESPECT TO THE SILENZIO CPAP OR ITS COMPONENT PARTS AND ALL
IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANT-
ABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE HEREBY EXPRESSLY DISCLAIMED
AND EXCLUDED BY NIDEK MEDICAL. Nidek Medical’s exclusive liability with respect to the
Silenzio shall be to repair (at Nidek Medical’s sole option) the Silenzio or any of its component
parts that prove to be defective in materials or workmanship during the warranty period. Normal
maintenance required during the warranty period is not included in this warranty. No claim of
any kind whatsoever against Nidek Medical with respect to the Silenzio or its component parts
whether or not based in contract, warranty, negligence, strict liability in tort, or any other theory
of law, shall be greater in amount than the purchase price of the Silenzio. Without limiting the
generality of any of the foregoing, Nidek Medical shall in no event be liable for any special, in-
direct, incidental, or consequential damages.

FOR SERVICE CONTACT YOUR EU Representative

AUTHORIZED SILENZIO DEALER:
mdi Europa Gmbh
Wittekemp 30
D-30163 Hannover,
Germany
Phone:+49-511-39 08 95 30
DFNidek Medical Products, Inc. Fax: +49-511-39 08 95 39
3949 Valley East Industrial Drive email:
Birmingham, Alabama 35217 U.S.A. info@mdieuropa.com
Tel: 205-856-7200 Fax: 205-856-0533 www.mdieuropa.com
PN 2010-2110-A REV 07/03

Technical Guide July 2003 24