Dymedso Frequencer V2x User manual

I N S T R U C T I O N
M A N U A L
model V2x
Acoustical airway clearance device
. 5.04.1
®

SAFETY SYMBOLS
This manual uses the following safety symbols. They denote critical
information. Please read them carefully.
WARNING
Failure to abide by the information with a WARNING may result in
serious injury and can be life threatening.
CAUTION
Failure to abide by the information with a CAUTION may result in
moderate injury and/or property or product damage.
TYPE BF EQUIPMENT
ELECTROMAGNETIC RADIATION
CONSULT INSTRUCTIONS FOR USE
TEMPERATURE LIMITATION
HUMIDITY LIMITATION
CLASS II DOUBLE INSULATED ELECTRICAL DEVICE
PROHIBITION
Copyright © by Dymedso inc. All rights reserved. No part of this manual may be
reproduced, stored in a retrieval system, or transmitted, in any form or by any
means, electronic, mechanical, or otherwise, without the prior written permission
of Dymedso inc. Dymedso inc. is under no obligation to hold any submitted
material or information confidential unless prior arrangements are made pursuant
to Dymedso’s receipt of said information. Although every effort has been made to
ensure that this manual provides up-to-date information, please note that
Dymedso’s Frequencer® V2x specifications are subject to change without
notice. Frequencer®is a registered trademark of Dymedso inc.

The Frequencer® instruction manual
_2
Table of Contents
[
1 ]
Indications for use
3
[
2 ]
Contraindications
4
[
3 ]
General Information
5
[
4 ]
Description
5
[ 4_a ] The components
5
[ 4_b ] Control unit functionalities
7
[ 4_c ] Control unit connections
8
8
8
9
10
11
11
11
12
12
13
14
19
[ 5 ] Treatment in a controlled environment
[ 6 ] Preparing for treatment
[ 7 ] Treatment with the Frequencer® V2x
[ 8 ] Cleaning
[ 9 ] Maintenance
[ 10 ] Storage
[ 11 ] Assistance
[ 12 ] Disposal
[ 13 ] Problem solving
[ 14 ] Specifications
[ 15 ] EMC requirements
[ 16 ] ESD precautionary procedures
[ 17 ] FREQUENCER® V2x, PARTS AND ACCESSORIES 21

3_
[1] Indications for use
The Frequencer® V2x provides airway clearance therapy and promotes
bronchial drainage by inducing vibration in the chest walls. This device
is intended to be a component of chest physiotherapy by providing a
convenient method of external thorax
manipulation.
It is intended for patients having respiratory ailments which involve
defective mucociliary clearance, as is typical in patients suffering from
cystic fibrosis as well as chronic bronchitis, bronchiectasis, ciliary
dyskinesia syndromes, asthma, muscular dystrophy, neuromuscular
degenerative disorders, post-operative atelectasis and thoracic wall
defects. Indications for this form of therapy are described in the Clinical
Practice Guidelines for Postural Drainage Therapy of the American
Association for Respiratory Care (AARC) published in 1991 . This particular
device provides a gentler, less painful form of therapy from the traditional
“clapping” method of postural drainage therapy, allowing it to be used
on patients who cannot be treated by clapping.
The Frequencer® V2x is suitable for use in all patient-care environments
including home health-care.
WARNINGS
•Use only original Frequencer® V2x parts or replacement parts sold
by Dymedso. Do not substitute the power supply.
•If patient experiences any discomfort or pain while using the
Frequencer® V2x, stop the treatment and consult a physician .
•This instruction manual is not intended to supersede established
medical protocols.
•This device is not a form of life support.
•Repairs must be performed by the manufacturer, the
manufacturer’s distributor or authorized agent. Do not open this
equipment including the transducer or the power supply.
•This equipment is not suitable for use in the presence of a
flammable anaesthetic mixture in combination with oxygen or air, or
in the presence of nitrous oxide.
•To avoid electrical shock, disconnect the power cord before
cleaning. Do not immerse the device in any fluids.
The Frequencer® instruction manual

_4
[2] Contraindications
IT IS IMPORTANT TO READ AND UNDERSTAND THE FOLLOWING
CONTRAINDICATIONS. IF YOU HAVE ANY QUESTIONS ABOUT
YOUR CONDITION OR THE USE OF YOUR FREQUENCER® V2x,
CONSULT YOUR
PHYSICIAN.
WARNING: Tests with the Frequencer® V2x were performed
with patients in a sitting or slightly reclined position. Use of
the Frequencer® V2x is contraindicated in the following cases:
_subcutaneous emphysema
_recent epidural spinal
infusion
or spinal anesthesia
_recent skin grafts, or flaps, on
the thorax
_burns, open wounds, and skin
infections of the thorax
_subcutaneous pacemaker
_tuberculosis of the
lungs
_lung contusion
_bronchospasm
_osteomyelitis of the ribs
_osteoporosis
_coagulopathy
_complaint of chest-wall pain
WARNING: When postural drainage is used, postural drainage
therapy is generally contraindicated if any of the following
conditions are present:
_intracranial pressure
(ICP) > 20 mm Hg
_recent head and/or neck injury
_acute spinal injury or
active
hemoptysis
_esophageal surgery
_recent spinal
surgery
(eg,
laminectomy) or acute
spinal injury
_recent
neurosurgery,
aneurysms, or eye surgery
_surgical wound or healing
tissue
_active hemorrhage with
hemodynamic instability
_emphysema
_bronchopleural
fistula
_pulmonary edema associated
with congestive heart failure
_large pleural effusions
_pulmonary embolism
_intolerance of position changes
_rib fracture,
with or without
flail chest
_uncontrolled hypertension
_distended abdomen
_recent gross
hemoptysis
related to recent lung
carcinoma treated surgically
or with radiation therapy
_uncontrolled airway at risk
for aspiration (tube feeding
or recent meal
If you are uncertain about any of the information,
consult your physician.
The Frequencer® instruction manual

5_
The Frequencer® instruction manual
[3] General Information
The Frequencer
® V2x
is to be used only as described in this manual and
only as prescribed by a physician. Failure to do so could result in serious
injury or death.
We recommend that, before you begin using the Frequencer® V2x for in-
home use, you use it in a supervised setting such as a physician’s office or
at home under the guidance of a trained care-giver.
Close supervision is necessary throughout the treatment when the
Frequencer® V2x is used by children or patients with limited mobility or
reduced cognitive abilities.
This instruction manual is designed to help you use the Frequencer® V2x.
If you have any questions about the effectiveness of the Frequencer® V2x,
or about the frequency level, treatment intensity and duration of the
treatments, please consult your physician.
Read this manual carefully before using the Frequencer® V2x for
the first time.
[4] Description
[4_A] THE COMPONENTS
The Frequencer® V2x includes a basic module to control frequency level
and treatment intensity (control unit), a transducer which emits acoustic
waves, a power supply, an electrical cable and a user manual.

The Frequencer® instruction manual
_6
THE FREQUENCER® V2x
ACCESSORIES INCLUDE:
Refer to page 21 for Frequencer® V2x parts and accessories
1_The transducer adapters
The
t r a n s d u c e r operates with single patient-use disposable
a d a p t e r s with filter. They come in 4 sizes.
Has a 1″ diameter opening and is for very small children,
Has a 2″ diameter opening and is for children,
Has a 3″ diameter opening and is used young
adults, and
Has a 4″ diameter opening and is for adults.
Always use the adapter
with the largest opening as long as the
opening is sealed when placed on the treatment area. An adapter with
filter can be reused for treatments to the same patient. A new adapter
with filter needs to be used in between different patients.
2_A Roll
stand
The base of the Frequencer® V2x is equipped with a fi x a t i o n p l a t e that
enables t h e device to be attached to a roll stand. The roll stand is sold
separately and is recommended for hospital use.
3_Carrying case
A foam padded carrying case with rollers can also be used to store and
protect the Frequencer® V2x. The carrying case is sold separately.
4_Flexible extension hose
For situations in which the weight of the transducer causes patient
discomfort, a 72 inch flexible extension hose may be affixed to a 1 inch
adapter.
5_Instruction manual
WARNING: The use of ACCESSORIES, transducers and cables other
than those specified, with the exception of transducers and cables sold
by Dymedso as replacement parts , may result in increased EMISSIONS
or decreased IMMUNITY of the Frequencer® V2x.

7_
The Frequencer® instruction manual
[4_B] CONTROL UNIT FUNCTIONALITIES
The interface on the control unit includes a touch screen which offers the
following functions:
1_START function to start treatment... PAUSE function appears when
the START function is pressed.
2_PAUSE to temporarily suspend treatment.
3_TREATMENT INTENSITY slide UP and DOWN to increase and
decrease intensity of treatment.
4_FREQUENCY LEVEL slide UP and DOWN to increase and decrease
the frequency level.
5_MENU button offers additional features:
LANGUAGE offers a choice of language on the Interface.
3-MINUTE BEEP (YES or NO) emits a beeping sound every 3 minutes.
DEFAULT SETTINGS offers a choice of default settings of Baby Level
(frequency at 40 Hz and treatment intensity at 10%) or Child Level
(frequency at 40 Hz and treatment intensity at 50%).
LOCK SETTINGS (YES or NO) limits frequency level changes to 1 Hz
and treatment intensity to 1% using + or - buttons only.
1-2
5
3
4

The Frequencer®instruction manual 8
[4_C] CONTROL UNIT CONNECTIONS
A_ Plugging in the power supply.
B_ On/Off Push Button
.
A
B
[5] Treatment in a controlled environment
The Frequencer® V2x should not be used when the temperature exceeds
104o F (40o C) or goes below 4 1 o F
(5
o
C). If the device was exposed to an
extreme temperature for a prolonged period (e.g. after a long car ride)
let it return to operating temperature before using.
The Frequencer® V2x should not be used when the
humidity exceeds
93% (non-condensing) or goes below 15
% . If the device becomes
damp,
wait until it dries completely before using it.
WARNING: The Frequencer® V2x should not be stacked with other
equipment. If such placement becomes necessary, the Frequence®V2x
should be closely observed to ensure normal operation.
WARNING: The
ventilation openings should never be obstructed.
[6] Preparing for treatment
Before using the Frequencer®V2x for the first time, please ensure the
device has been cleaned as indicated in section 8.
STEP
1 : Ensure you have all the components (see section 4_A).
STEP 2: Connect the power supply to the control
unit.
STEP 3: Plug the electrical cable into the power
supply.
STEP 4: Plug the electrical cable into a proper AC electrical
ou tlet.
WARNING: INSPECT THE POWER CORD OFTEN FOR ANY SIGNS OF
DAMAGE. REPLACE A DAMAGED CORD
IMMEDIATELY.
WARNING: DO NOT PLACE THE
FREQUENCER
®
CONTROL UNIT IN A
POSITION THAT MAKES IT DIFFICULT TO
DISCONNECT FROM THE MAIN
POWER SUPPLY.
104° F
(40° C)
41° F
(5° C)
93%
15%

9_
The Frequencer® instruction manual
[7] Treatment with the Frequencer® V2x
men women
STEP 1 : Select the correct adapter (i.e., the largest adapter that will form
a complete seal when applied to the chest area). Tightly affix the
adapter onto the transducer. (Refer to [4_a], The components, for more
info on adapters).
WARNING: Always make sure that there is an adapter on the transducer
before pushing the START button. Do not substitute or modify the adapters
supplied by Dymedso; it could seriously damage the transducer.
STEP 2: Patient should be in a sitting or slightly reclined position. The
operator can be beside the patient to administer the
treatme nt.
WARNING: Do not eat or drink during a therapy session. Doing so could
cause a choking hazard.
STEP 3: Push power switch on the back of the Frequencer® V2x control
unit to turn on device. A green light will illuminate on the top of the control
unit. It may take from 35 to 40 seconds for the control unit interface to
activate. By default, frequency level is set at 40 Hz and treatment intensity
at 50%. (Refer to [4_b], Control unit functionalities, to change default
settings).
STEP 4: Before starting treatment, reset treatment intensity to better
suit patient’s size and condition.
WARNING:
The decision on the final treatment intensity is the
responsibility of the patient’s qualified treating clinician, physician,
respiratory therapist
or physiotherapist.