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1. _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 A WARNING When postural drainage is used postural drainage therapy is generally contraindicated if any of the following conditions are present _intracranial pressure GIP ZOMIN lie _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 _04 3 O5 General Information This instruction manual is designed to help you use the Frequencer If you have any questions about the effectivene2. 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 reflection from structures objects and people 6060I 1 2 lEG2007 The Frequencer instruction manual NO _20 For technical assistance 1 877 DYMEDSO 396 3376 info dymedso com Dy so 901 A Du Cure Boivin Blvd Boisbriand Quebec Canada J7G 2S8
3. Control unit functionalities 4_c Control unit connections Treatment in a controlled environment Preparing for treatment Treatment with the Frequencer Cleaning Maintenance Storage Assistance Disposal Problem solving Specifications EMC requirements ESD precautionary procedures The Frequencer instruction manual 14 18 202 I Indications for use The Frequencer 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 is suitable for use in all environments includin
4. Frequencer instruction manual ELECTROMAGNETIC ENVIRONMENT GUIDANCE The Frequencer uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference with nearby electronic equipment The Frequencer is Suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network which supplies buildings used for domestic purposes GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The Frequencer is intended for use in the electromagnetic environment specified below The user of the Frequencer should ensure it is used in the appropriate environment IMMUNITY TEST Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 IEC 60601 TEST LEVEL COMPLIANCE 6 kV 6 kV contact contact 2 kV 2 kV for for power power supply lines 1kV for input output lines supply lines 1 kV for input output 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 ELECTROMAGNETIC ENVIRONMENT GUIDANCE Floor should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power should be that of a typical commercial or hospital envi
5. temperatures for a prolonged period eg during a long car ride let it return to room temperature before use it If the device gets wet let it dry completely before use Assistance If for any reason you do not think the device is working properly the troubleshooting list below can help you find the cause of the problem If you cannot solve the problem contact DYMEDSO Customer Service at 1 877 DYMEDSO 396 3376 or info dymedso com Do not attempt to repair or disassemble the device This will void the warranty Under no circumstances should you modify the cable or transformer Only use products sold by DYMEDSO Otherwise you could damage your device and void the warranty The Frequencer instruction manual 12 Disposal WW When necessary dispose of the Frequencer and its accessories In accordance with local regulations Please note the device houses a lithium battery Problem solving PROBLEM The control unit does not Start after pressing the POWER SWITCH button The control started up but there is no noise coming from the transducer The transducer works but cannot adjust the frequency level The transducer works but cannot adjust the treatment intensity POSSIBLE CAUSES 1 The power supply is not plugged into the device Verify the connectors are plugged in 2 Verify the power supply is plugged into a proper power outlet 3 There is no voltage power in the wall outlet Verify
6. 4 permanent adapters one of each size Frequencer V2 and V2x use the same control unit and the same four sizes of adapters 4 A Roll stand The base of the Frequencer is equipped with a fixation plate that enables the device to be attached to a roll stand The roll stand is sold separately and is recommended for hospital use 5 Carrying case A foam padded carrying case with rollers can also be used to store and protect the Frequencer The carrying case is sold sepa rately 6 Flexible extension hose For situations in which the weight of the transducer causes patient discomfort a 72 inches flexible extension hose may be affixed Pa toalinch adapter A 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 for internal components may result in increased EMISSIONS or decreased IMMUNITY of the Frequencer The Frequencer M instruction manual _06 07_ 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 l
7. Do not use harsh chemicals on any part of the device We recommend cleaning the Frequencer with a damp cloth To remove Stubborn stains use hot water and mild soap and wipe off the soap with a dry clean cloth A CAUTIONS Do not immerse or rinse the Frequencer or its peripherals If you accidentally spill liquid on the device disconnect the unit from the power source Contact your Biomed Department regarding the continued safety of the unit before placing it back in operation Do not spray cleaning agent on the chassis Do not use disinfectants that contain phenol Do not autoclave or clean the Frequencer or its peripherals with strong aromatic chlorinated ketone ether or Esther solvents sharp tools or abrasives Never immerse electrical connectors in water or other liquids WARNING To avoid electrical shock disconnect the power cord before cleaning Do not immerse the device in any fluids The Frequencer instruction manual _10 9 10 1 NL Maintenance No special maintenance is required However the Frequencer contains a lithium battery to display the time and date which should work for many years If it stops working you must return the unit to the manufacturer the manufacturer s distributor or authorized agent to have it replaced Storage CAUTION When not in use put all components in the carrying case and store in a dry place at room temperature If the device must be exposed to extreme
8. FREQUENCER model v2 v2x Acoustical airway clearance device Rev 14 05 22 SAFETY SYMBOLS This manual uses the following safety symbols They denote critical information Please read them carefully A WARNING Failure to abide by the information with a WARNING may result in serious injury and can be life threatening AN CAUTION Failure to abide by the information with a CAUTION may result in moderate Injury and or property or product damage Q INDICATES A PROHIBITED ACTION TYPE B EQUIPMENT ALTERNATING CURRENT DIRECT CURRENT ELECTROMAGNETIC RADIATION INDOOR USE ONLY 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 efforthas been madetoensurethat this manual provides up to date information please note that Dymedso s Frequencer specifications are subject to change without notice Frequencer is a registered trademark of Dymedso Inc Ole The Frequencer instruction manual Table of Contents Indications for use Contraindications General Information Description 4 a The components 4b
9. an electromagnetic environment in which radiated RF disturbances are controlled The customer or the user of the ME EQUIPMENT or ME SYSTEM can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ME EQUIP MENT or ME SYSTEM as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 MHz to maximum outside ISM in ISM bands 800 MHz 2 5 GHz output power bands of transmitter W 0 01 0 1 1 10 100 For transmitters rated at a maximum output power not listed above the recommended separa tion distance d in metres 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 scientific 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
10. autionary procedures Please refer to the section below on Minimum ESD Procedures It is recommended by Dymedso that all staff involved in the assembly and or installation and or repair of the Frequencer receive Explanation and Training in ESD Procedure MINIMUM ESD PROCEDURES DESIGN IN IMMUNITY by designing products and assemblies to be as immune and reasonable from the effects of ESD DEFINE THE LEVEL OF CONTROL needed in your environment IDENTIFY AND DEFINE the electrostatic protected areas EPA the areas in which you will be handling sensitive parts ELIMINATE AND REDUCE GENERATION by reducing and eliminating Static generating processes keeping processes and materials at the same electrostatic potential and by providing appropriate ground paths to reduce charge generation and accumulation DISSIPATE AND NEUTRALIZE by grounding ionization and the use of conductive and dissipative static control materials PROTECT PRODUCTS FROM ESD with proper grounding or shunting and the use of static control packaging and materials handling product The Frequencer instruction manual 18 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 reflection from structures objects and people NOTE 3 Medical Electrical
11. equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this document NOTE 4 It is essential that the actual shielding effectiveness and filter attensuation of the shielded location be verified to assure that they meet the minimum specification Field strengths from fixed 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 fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Frequencer is used exceeds the applicable RF compliance level above the Frequencer should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Frequencer Over the frequency range of 150 kHz to 80 Mhz the field strengths Should be less than 3 V m The Frequencer instruction manual RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND THE FREQUENCER FOR LIFE SUPPORTING Recommended separation distances between portable and mobile RF communications equipment and the Frequencer v2x The ME EQUIPMENT or ME SYSTEM is intended for use in
12. evel 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 ireguency kvel ieatmenmi mieren menu start AD Hr 10 language eng i minute fee ies Mule defaut pedang baby 00 00 The Frequencer instruction manual 4_C CONTROL UNIT CONNECTIONS A_Plugging in the power supply B_Power switch 5 Treatment in a controlled environment A CAUTION The Frequencer should only be used in normal tempera tures and humidity If for any reason the device becomes damp wait until it dries completely before using it We do not advise using the Feo WE Vea anen tne tanpere xceecs SEE S0 O OF goes below 50 F 10 C If the device was exposed to an extreme temperature for a prolonged period eg after a long car ride let it return to room tem perature at least two hours before using A WARNING The Frequencer should not be used next to or stacked with any other equipment If such a placement is necessary the Frequencer should be closely observed to ensure normal operation A WARNING The ventilati
13. g domestic environments A WARNING Use only original Frequencer M parts or replacement parts sold by Dymedso Do not substitute the power supply Power supply Must be am ASTEC model DPS55 M A WARNING If patient experiences any discomfort or pain while using Hie Pec den aA Ii Aa Aa Aa A WARNING This instruction manual is not Intended to supersede established medical protocols A WARNING This device is not a form of life support A WARNING Repairs must be performed by the manufacturer the manufacturers distributor or authorized agent Do not open this equipment including the transducer or the power supply A WARNING 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 A WARNING To avoid electrical shock disconnect the power cord before cleaning Do not immerse the device in any fluids 03 The Frequencer M instruction manual i IT IS IMPORTANT TO READ AND UNDERSTAND THE FOLLOWING CONTRAINDICATIONS IF YOU HAVE ANY QUESTIONS ABOUT YOUR CONDITION OR THE USE OF YOUR FREQUENCER CONSULT YOUR PHYSICIAN AN WARNING Tests with the Frequencer were performed with patients in a sitting or slightly reclined position Use of the Frequencer is contraindicated in the following cases _subcutaneous emphysema _recent epidural spinal infusion or spinal anesthesia _recent skin grafts or flaps on the thorax
14. on openings should never be obstructed 6 Preparing for treatment Before using the Frequencer 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 outlet A WARNING INSPECT THE POWER CORD OFTEN FOR ANY SIGNS OF DAMAGE REPLACE A DAMAGED CORD IMMEDIATELY The Frequencer M instruction manual _08 7 Treatment with the Frequencer 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 al The components for more info on adapters A WARNING Always make sure that there Is an adapter on the transducer 09 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 STEP 3 Push power switch on the back of the Frequencer to turn on device 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 si
15. quencer instruction manual GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC IMMUNITY The Frequencer is intended for use in the electromagnetic environment specified below The user of the Frequencer should ensure it is used in the appropriate environment IEC 60601 IMMUNITY TEST TEST LEVEL Conducted 3 Vrms RF 150 kHz to IEC sooo eo Mae Radiated RF 3 V m IEC ne 61000 4 3 35 GHZ Ves COMPLIANCE LEVEL 3 Vrms 3 V m ELECTROMAGNETIC ENVIRONMENT GUIDANCE Portable and mobile RF communications equipment should be used no closer to any part of the Frequencer including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 2VP d 1 2VP 80 MHz to 800 MHz v 2 3VP 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range The Frequencer instruction manual 16 ESD Precautionary procedures It is recommended that all staff involved in the assembly and or installation of the Frequencer receive an explanation of the ESD warning symbol and training in ESD prec
16. ronment Mains power should be that of a typical commercial or hospital environment ESSENTIAL PERFORMANCE OF THE FREQUENCER TYPE Generated Frequency Sound Pressure Output 15 Dap MAXIMUM 65 Hz 0 4 PSI The Frequencer instruction manual Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Power frequency 50 60 Hz Magnetic Field IEC 61000 4 8 lt 5 U_ gt 95 dip in U_ for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles lt 5 U gt 95 dip U fOr Ss 3 A m lt 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U_ for 5 cycles 70 v 30 dip in U for 25 cycles lt 5 U_ gt 95 dip MOATO S s 3 A m Mains power quality should be that of a typical home or hospital If the user of the Frequencer requires continued operation during power mains interruptions it is recommended that the Frequencer be powered from an uninterruptible power supply or from a battery If the user experiences malfunctions with the Frequencer it may be necessary to position the Frequencer further from Sources Of power frequency magnetic fields The power frequency magnetic field should be measured in the intended installation location to ensure that it is sufficiently low Note U is the AC mains voltage prior to application of the test level The Fre
17. ss of the Frequencer or about the frequency level treatment intensity and duration of the treatments please consult your physician Read this manual carefully before using the Frequencer for the first time Description 4_A THE COMPONENTS The Frequencer includes a basic module to control frequency level and treatment intensity control unit and a transducer which emits acoustic waves TRANSDUCER CONTROL UNIT The Frequencer operates with 1_One 1 power supply 2_One 1 grounded electrical cable 110V AC THE FREQUENCER ACCESSORIES INCLUDE 3_Four different sized adapters To optimize treatment efficiency with patients of all ages four different sizes of adapters can be fitted on the transducer The adapter with a 1 opening is for very small children The adapter with a 2 opening is for children The adapter with a 3 opening is for young adults The adapter with a 4 opening is for adults The Frequencer instruction manual For hospitals and usage in multi patient set tings we recommend the Frequencer v2x with disposable adapters and filter The dis posable adapters with filters are sold sepa rately A WARNING The re use of disposable adapt ers with filter between multiple patients may result in cross patient contamination For home use and usage by a single patient the Frequencer V2 operates with perma nent adapters The Frequencer V2 comes with
18. the outlet is working by plugging in another device lamp clock Make sure the control is not on PAUSE and the treatment intensity is higher than 0 Contact DYMEDSO Customer Service Contact DYMEDSO Customer Service TO REACH US 1877 DYMEDSO 396 3376 INFO DYMEDSO COM The Frequencer instruction manual 114 Specifications PRODUCT USE Temperature Humidity Atmospheric pressure TRANSPORT amp STORAGE Temperature Humidity Standards compliance Mode of operation AC power consumption Type of protection against electric shock Degree of protection against electric shock Degree of protection against ingress of water cm 10 to 30 C 15 to 95 non condensing 76 7 to 102 kPa 12 to 60 C 15 to 95 non condensing IEC 60601 1 Continuous 100 240Vac 50 60Hz 2A Class Type B Applied part IPXO ordinary equipment The Frequencer instruction manual 15 EMC Requirements GUIDANCE AND MANUFACTURER S DECLARATION ELECTROMAGNETIC EMISSIONS The Frequencer should be use in the electromagnetic environments specified below The user of the Frequencer should ensure that it is used in such an environment EMISSION TEST RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000 3 2 Voltage fluctuations Flicker emissions IEC 61000 3 3 COMPLIANCE Group 1 Class B Group 1 Class B ClassA None Compliant None The
19. ze and condition STEP 5 Place transducer on chest wall and press START STEP 6 Adjust frequency level one Hz at a time until vibration is felt on back or other part of chest cavity At the right frequency level there Should be a light vibration in patient s voice when transducer is applied to the upper lobes A Frequency level will most likely be within a 40 50Hz range B If patient is able to huff or actively breathe it may assist with airway clearance The Frequencer instruction manual STEP 7 Apply transducer to the six areas for 2 3 minutes each Starting in the lower right and left lobe and working upward on each side see page 09 figure 1 NOTE To optimize the seal place the transducer with adapter directly onto the skin If treatment needs to be suspended PAUSE will hold treatment until START is pressed again STEP 8 Do not apply any pressure on the transducer when applied to the chest Simply support transducer while assuring complete seal Transducer is much easier to support while patient is in a slightly reclined position STEP 9 Ajter treatment push PAUSE button and turn power switch off before unplugging NOTE Following treatment redness is not uncommon in the area or areas treated by the Frequencer A CAUTION ALWAYS FOLLOW THE PHYSICIAN S INSTRUCTIONS NEVER USE THIS DEVICE ON THE HEAD OR EARS Cleaning There are no special procedures or products for cleaning the Frequencer
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