OPERATING INSTRUCTIONS FRIGOSTREAM GB

Transcription

1 OPERATING INSTRUCTIONS FRIGOSTREAM GB

2 Legal Notice Distribution, reproduction and translation of the software and its documentation (or excerpts thereof) are prohibited without the prior written consent of PHYSIOMED ELEKTROMEDIZIN AG. PHYSIOMED ELEKTROMEDIZIN AG reserves the right to change the software and associated data as well as the documentation without notice. All other rights reserved. PHYSIOMED ELEKTROMEDIZIN AG Hutweide 10 D Schnaittach/Laipersdorf (Germany) Phone: Fax: Internet: FRIGOSTREAM is produced in accordance with the quality requirements set forth in DIN EN ISO 13485:2003 and complies with current safety standards and regulations in accordance with the Medical Devices Act as set forth in Directive 93/42/EEC on Medical Devices dated 14 June The conformity with the specified directive is confirmed by the CE marking on the instrument. The declaration of conformity can be requested under the above mentioned address. Last updated February 16, 2010.

3 PHYSIOMED ELEKTROMEDIZIN AG Table of Contents Table of Contents Chapter 1 Introduction Conventions Used Instrument Symbols General Instructions Instrument Overview Instrument Description Application Rheumatology Surgery Neurology Sports Medicine Contraindications Chapter 2 Display and Control Elements Function of the Display and Control Elements Display <1> Mode Key <2> Start/Stop Key <3> Plus/Minus Keys <4> Power Switch Chapter 3 Operation of the Instrument Start-up of the Instrument Functional Test Instrument Errors Defrosting the Instrument Chapter 4 Treatment Appendix A Appendix A.1 Customer Service, Maintenance, Service A.2 Cleaning and Disinfecting Agent A.3 Transport FRIGOSTREAM i

4 Table of Contents PHYSIOMED ELEKTROMEDIZIN AG A.4 Service Life and Disposal A.5 Electromagnetic Compatibility A.6 Technical Data A.7 Manufacturer Information Appendix B Scope of Delivery and Accessories B.1 Scope of Delivery B.2 Available Accessories Appendix C Supplementary Documents C.1 Manufacturer s Recommendation Index ii FRIGOSTREAM

5 PHYSIOMED ELEKTROMEDIZIN AG 1 Introduction Chapter 1 Introduction By purchasing FRIGOSTREAM you have acquired an extremely versatile, advanced cryotherapeutic instrument. However, it can be utilized optimally only once you are informed about the function of the control elements. Therefore, read the given instruction manual carefully and make yourself thoroughly familiar with the instrument before its use. 1.1 Conventions Used Please note the following typographical conventions in these Operating Instructions: Cross references and important terms used for the first time in this document are written in italics. Names of menus and symbols on the display are written in bold typeface. Paragraphs that deserve special attention are highlighted in the following way: Symbol Type Meaning Tip Note Important Caution Intended to give you some extra hints for more convenient operation Provides background information for better understanding Prevents misunderstandings that might lead to limited operation of the instrument or insufficient therapeutical results Alerts you in cases of possible damage to the instrument or risks of injury 1.2 Instrument Symbols The symbols affixed to the instrument have the following meaning: Symbol Meaning Make sure that the instrument is disposed of in an environmentally sound manner! It is absolutely necessary to separate old instruments from household waste (see Service Life and Disposal on page 14) before disposal once their lifetime has expired! 1.3 General Instructions FRIGOSTREAM may be used only in dry rooms suitable for medical purposes as set forth in DIN VDE , Application Group 1. These are rooms with beds, physiotherapy rooms, massage rooms and practitioner s rooms. The instrument complies with the technical requirement of VDE 0750/IEC 60601, classification in accordance with EU Directive on Medical Devices (93/42/EEC): Class IIa. FRIGOSTREAM 1

6 1 Introduction PHYSIOMED ELEKTROMEDIZIN AG Caution The instrument may be operated only and exclusively by medically qualified personnel after appropriate instruction! Kindly ensure proper usage of the instrument in accordance with the instruction manual! The instrument is unsuitable for use in explosive areas and hydrotherapy rooms. A drastic change in temperature must be avoided owing to possible bedewing of the instrument; it must be put into operation only after a temperature equalisation! The operation of the instrument in the proximity of (e.g. at a distance of 1 m from) a shortwave or microwave therapeutic instrument can lead to fluctuations in the original values of the instrument and must, therefore, be absolutely avoided! 1.4 Instrument Overview Control Panel Instrument View Legend 1 Display 2 Mode Key 3 Start/Stop Key 4 Plus/Minus Keys 2 FRIGOSTREAM

7 PHYSIOMED ELEKTROMEDIZIN AG 1 Introduction 1.5 Instrument Description FRIGOSTREAM is a cryotherapeutic instrument, which has been applied successfully in different medical fields. It is primarily foreseen as a therapeutic instrument for application in a clinical and therapeutic environment. The cooling circuit of the FRIGOSTREAM is a closed circuit. The instrument has been filled with a predefined volume of protective cooling medium and is hermetically sealed. The instrument complies with all the applicable safety standards, in particular: IEC : Electronic Medical Devices, Part 1: General Safety Requirements 1.6 Application Cryotherapy is used in different medical fields. These fields include: rheumatology orthopaedics surgery sports medicine neurology internal medicine The treatment of these indications takes place through the application of different cooling media. These are: ice chips compresses ice packs mudpacks cooling spray nitrogen cooling air Rheumatology Applications of cryotherapy within rheumatology in connection with massages and kinesitherapy: In the case of inflammatory diseases: arthritides spondylitides bursitides gout rheumatoid arthritis in acute episode In the case of non-inflammatory diseases: arthroses acute arthrosis humeroscapularis FRIGOSTREAM 3

8 1 Introduction PHYSIOMED ELEKTROMEDIZIN AG acute epicondylitis myalgias lumbar ischialgias dorsalgias sacralgias acute lumbago acute cervical syndrome Surgery Applications of cryotherapy within accident surgery, orthopaedics, mouth and jaw surgery: prophylaxis of swellings in the case of fresh fractures and in the post-operative phase sprains crushing injuries contusions pulled muscles luxations (all kinds of injuries to the ligament and joint system) Sudeck's syndrome lymphedema after amputation of the breast prevention of reactive effusions acute inflammations Neurology Applications of cryotherapy within neurology: spastic hemipareses and parapareses neuralgias (e.g. migraine, trigeminus neuralgia) multiple sclerosis post-apoplectical conditions acute neuritis Sports Medicine Applications of cryotherapy within sports medicine: fresh sports injuries soft tissue injuries injuries to the ligament and joint system (e.g. muscle contusions, traumatic bursitis, humeral epicondylitis, cervical spine whiplash injury) 1.7 Contraindications May not be treated with FRIGOSTREAM in the case of: arterial occlusive diseases (especially Fontaine stages III and IV) grave functional blood circulatory disorders common cryoglobulinaemia 4 FRIGOSTREAM

9 PHYSIOMED ELEKTROMEDIZIN AG 1 Introduction cold urticaria trophic disturbances and tissue lesions Raynaud s symptomatology pregnancy (a treatment during pregnancy may be performed only in consultation with the attending doctor!) FRIGOSTREAM 5

10 2 Display and Control Elements PHYSIOMED ELEKTROMEDIZIN AG Chapter 2 Display and Control Elements The FRIGOSTREAM is designed in such a way that it is very easy to operate in spite of manifold functions. All the display and control elements are integrated in the housing in order that the surface can be cleaned easily and the instrument is free from dust. The micro-processor of the instrument monitors the safety-relevant components, prevents maloperation and tests the instrument every time it is switched on. 2.1 Function of the Display and Control Elements The individual display and control elements of the FRIGOSTREAM have been presented in the following sections. The numbers in angle brackets refer to the Instrument Overview on page Display <1> In the Display <1> the selectable therapy parameters are displayed depending upon the current context. Display <1> Mode Key <2> The Mode Key <2> above the Display <1> serves the purpose of selecting the programmes Flow, Time or Defrost. Mode Key <2> 6 FRIGOSTREAM

11 PHYSIOMED ELEKTROMEDIZIN AG 2 Display and Control Elements Start/Stop Key <3> The Start/Stop Key <3> above the Display <1> serves the purpose of starting and ending the therapy in the individual menus. Start/Stop Key <3> Plus/Minus Keys <4> The Plus/Minus Keys <4> below the Display <1> serve the purpose of setting the parameters in the individual menus. Plus und Minus Keys <4> Power Switch The Power Switch is on the rear side of the instrument. With the Power Switch, the mains voltage of the FRIGOSTREAM is switched on and/or off. FRIGOSTREAM 7

12 3 Operation of the Instrument PHYSIOMED ELEKTROMEDIZIN AG Chapter 3 Operation of the Instrument Caution The filter attached to the rear side of the instrument must be cleaned and/or washed every week! Note Optimal operating conditions are given if used in air-conditioned rooms and at a humidity of maximum 50-60%. In the worst case, there can be water formation in connection with a defrosting process if there is very high humidity and high outside temperatures. Important Increased humidity and temperatures above 30 C may impact the cooling performance of the instrument. The average permanent operating time may decrease with rising temperature and humidity. We recommend using FRIGOSTREAM only in air-conditioned rooms. 3.1 Start-up of the Instrument Before you can perform the first treatment with the FRIGOSTREAM, you must first start up the instrument properly. Since the instrument is mounted on rollers ex-factory, it may be operated only on level surfaces. Caution While setting up the FRIGOSTREAM, a distance of approx. 10 cm must be observed between the instrument and the wall, since it can otherwise result in loss of performance. The lateral distance from the walls must be minimum 20 cm. Instruments with strong electromagnetic fields (X-ray and/or diathermic apparatuses) can influence the functioning of the instrument. How to Start up the Instrument (1) Make sure that the instrument is switched off (the Power Switch is on Position 0). (2) Plug the power cord on the rear side of the instrument tightly into the power socket. A safe connection can be established via a shockproof socket with protective earthing conductor. (3) Actuate the Power Switch on the rear side of the instrument. (4) The instrument cools down to the point where the operating temperature is achieved. The message Loading flashes on the display and the status of the cooling process is displayed by means of a progress bar. 8 FRIGOSTREAM

13 PHYSIOMED ELEKTROMEDIZIN AG 3 Operation of the Instrument Progress Display of the Cooling Process At the end of the cooling phase, the instrument automatically changes over to the menu Flow and is then ready for operation. For longer treatments, it is urgently recommended to allow the instrument to cool down for another minutes. The further progress of the cooling is no longer visible in the display during this time span. 3.2 Functional Test If you are not sure as to whether your FRIGOSTREAM is working properly, you can conduct a self-test. How to Execute a Functional Test (1) Switch off the instrument by means of the Power Switch and then switch it on again. The instrument will conduct an automatic functional test whereby all the functions and original values will be checked. The instrument is now ready to operate. You are in the Flow menu. 3.3 Instrument Errors In case a malfunction is ascertained during the self-test or during operation, the Display <1> shows the message ERROR LOAD. In case the message was caused by a temporary disturbance and disappears after a brief period, the instrument is immediately ready to operate once again without switching off and on. However, if the error continues, the message once again appears. In this case, switch the instrument on and off several times. In doing so, the instrument will conduct a self-test (see Functional Test on page 9). Ascertain afterwards as to whether the message is still being displayed. Important Notify your service partner in case the error recurs even after several self-tests! Under no circumstances is it allowed to carry out any treatment unless the functional fitness of the instrument is ensured! FRIGOSTREAM 9

14 3 Operation of the Instrument PHYSIOMED ELEKTROMEDIZIN AG 3.4 Defrosting the Instrument In case there is a perceptible decrease in air flow rate or small ice particles are blown out (as a rule, only after approx. 4 hours of continuous operation) you ought to defrost the instrument in order that the full air flow rate can be guaranteed. How to Defrost the Instrument (1) Press the Mode key twice in order to reach the Defrost menu. Defrost Menu (2) Press the Start/Stop key for approx. 5 seconds. The defrosting process starts. The message Run flashes on the bottom right of the display. In addition, the current storage temperature is displayed. The defrosting process is running (3) The defrosting process runs until a storage temperature of +10 C is achieved. Thereafter, the FRIGOSTREAM once again cools down automatically to the operating temperature. 10 FRIGOSTREAM

15 PHYSIOMED ELEKTROMEDIZIN AG 4 Treatment Chapter 4 Treatment The FRIGOSTREAM knows the following menus and operating conditions: Flow: Adjust the blower position and perform the treatment Time: Adjust the treatment time Defrost: Defrost the instrument How to Perform a Treatment (1) Make sure that the instrument is ready to operate (see Start-up of the Instrument on page 8). You are in the Flow menu. (2) Press the Start/Stop key for starting the treatment. The message Run flashes on the bottom left of the display. (3) Set the desired blower position by means of the Plus and Minus keys (nine positions). On the Display <1> the set blower position is displayed: Flow Menu (4) Once again press the Start/Stop key, if you wish to end the treatment. Note You can also limit the treatment to a specific period by setting a treatment time (see How to Set the Treatment Time on page 11). Once the treatment time is over, the blower switches off. How to Set the Treatment Time (1) Press the Mode key, in order to reach the Time menu. Time Menu FRIGOSTREAM 11

16 4 Treatment PHYSIOMED ELEKTROMEDIZIN AG (2) Set the desired treatment time by means of the Plus and Minus keys. On the Display <1> the set set treatment time is displayed. Continuous treatment with adjusted therapy time Note You can interrupt the treatment at any time by pressing the Start/Stop key. In the Time menu, If you do not change the treatment time, the instrument automatically changes over to the Flow menu after a few seconds. 12 FRIGOSTREAM

17 PHYSIOMED ELEKTROMEDIZIN AG Appendix Appendix A Appendix Cooling Medium The cooling circuit of the cryotherapeutic instrument FRIGOSTREAM is a closed system. The instrument has been filled with a predefined volume of protective cooling medium and is hermetically sealed. Thus, no maintenance of the cooling circuit is required. A.1 Customer Service, Maintenance, Service The manufacturer is responsible only for the original security relevant properties of the instrument. The instrument must be used generally in conformance with the user manual. Maintenance measures on the instrument may be carried out only at the PHYSIOMED ELEKTROMEDIZIN AG authorised locations. If the work is carried out by such locations, a certification should be obtained from them about the type and extent of the work. possibly with information relating to the modifications in the rated data or the work range. The certification must also contain the date of execution as well as company name and signature. Failed components, which influence the safety of the instrument, must be replaced with original parts. Circuit diagrams, parts lists and service instructions shall be made available to qualified technical personnel of the user on request. We recommend carrying out regular servicing of the instrument and accessories. The defined safety-relevant inspections are given in our manufacturer's recommendations (see Manufacturer s Recommendation on page 17). A.2 Cleaning and Disinfecting Agent Clean the instrument and accessories regularly with customary chlorine-free and bleach-free cleaning agents (e.g. a disinfecting agent based on aldehyde). In doing so, make absolutely sure the instrument is previously switched off! Clean the instrument with a soft cloth. Make sure that no liquid penetrates into the instrument during the cleaning! We recommend that you clean the hand-piece of the tube likewise with a customary disinfecting agent, e.g. Dismozon pur. Caution If set up in extremely dirty rooms, the condensers and cooling units must be cleaned of dust and dirt approx. every 6 months! Caution The filter attached to the rear side of the instrument must be cleaned and/or washed every week! FRIGOSTREAM 13

18 Appendix PHYSIOMED ELEKTROMEDIZIN AG A.3 Transport In order to avoid all kinds of transportation losses, the shipment of a FRIGOSTREAM must always be undertaken in the original packing envisaged for it. The instrument must not be transported in recumbent position. However, if this should be the case, the instrument ought not to be started up for another half an hour. A.4 Service Life and Disposal Due to legislation, the service life of this medical product has a limit of sieben years. The instrument has to be disposed in compliance with the legal obligations. Therefore, pay attention to the applicable regulations for environment protection. Please contribute to environment protection by not putting used instruments into your domestic waste. A.5 Electromagnetic Compatibility Declaration in accordance with Standard EN : Electromagnetic Compatibility Electronic medical instruments are subject to special precautionary measures in respect of electromagnetic compatibility. Portable and mobile HF communication instruments can influence electronic medical instruments. 14 FRIGOSTREAM

19 PHYSIOMED ELEKTROMEDIZIN AG Appendix A.6 Technical Data Protection Class VDE 0750 / IEC CE Marking Class in accordance with Directive on Medical Devices (93/42/EEC) Mains Supply Mains Frequency Mains Fuse Power Consumption Air Flow Rate Power Drain Length of Treatment Tube Optimum Operating Temperature Admissible Operating Temperature 1, Type B in accordance with Directive 93/42/EEC on Medical Devices IIa V or V 50 / 60 Hz 2 x T16 A at V or 2 x T15 A at V 1,800 VA 1,500 l/min 9 Positions 170 cm C C Maximum Humidity 65% Dimensions (W x H x D) Weight 36.0 x 93.0 x 48.0 cm 53 kg A.7 Manufacturer Information Manufacturer mecotec GmbH Mannheimer Straße 14 D Pforzheim (Germany) For queries, kindly contact the distributor: PHYSIOMED ELEKTROMEDIZIN AG Hutweide 10 D Schnaittach/Laipersdorf (Germany) FRIGOSTREAM 15

20 Scope of Delivery and Accessories PHYSIOMED ELEKTROMEDIZIN AG Appendix B Scope of Delivery and Accessories Important For safety reasons, the instrument is to be used exclusively with original accessories. The use of other manufacturers' accessories is at the user's risk! B.1 Scope of Delivery FRIGOSTREAM is be delivered with the following accessories: Item No. Identification Quantity Cryotherapy instrument FRIGOSTREAM Nozzle attachment 5 mm Nozzle attachment 10 mm Nozzle attachment 15 mm Slotted nozzle Tube Operating Instructions (English) 1 B.2 Available Accessories For FRIGOSTREAM the following accessories are included in the delivery: Item No. Identification Nozzle attachment 5 mm Nozzle attachment 10 mm Nozzle attachment 15 mm Slotted nozzle Supporting arm FRIGOSTREAM incl. fixation (laser version) Tube Tube laser version 16 FRIGOSTREAM

21 PHYSIOMED ELEKTROMEDIZIN AG Supplementary Documents Appendix C Supplementary Documents C.1 Manufacturer s Recommendation FRIGOSTREAM 17

22 Index PHYSIOMED ELEKTROMEDIZIN AG Index A accessories 16 included 16 ambient temperature 15 application 3 arterial occlusions arterial 4 arthritides 3 arthritis rheumatoid 3 arthroses 3 arthrosis humeroscapularis ccute 3 available accessories 16 B bursitides 3 C CE marking 15 cervical syndrome acute 3 circulatory disorders functional 4 cleaning 13 cold urticaria 4 contraindications 4 control elements function 6 control elements 6 contusions 4 cooling 8 crushing injuries 4 cryoglobulinaemia 4 customer service 13 D Defrost 10 defrosting 10 dimensions 15 disinfecting agent 13 Display 6 display elements 6 function 6 disposal 14 disturbances trophic 4 dorsalgias 3 E electromagnetic compatibility 14 EMV 14 epicondylitis acute 3 error Codes 9 F functional test 9 functions 3 G gout 3 H hemipareses 4 I indications neurology 4 rheumatology 3 sports medicine 4 surgery 4 inflammations acute 4 instructions general 1 instrument description 3 instrument errors 9 instrument overview 2 instrument symbols 1 L load impedance 15 lumbago acute 3 lumbar ischialgias 3 luxations 4 lymphedema 4 M maintenance 13 manufacturer s recommendation 17 medical fields 3 mode key 6 modulation 15 multiple sclerosis 4 myalgias 3 18 FRIGOSTREAM

23 PHYSIOMED ELEKTROMEDIZIN AG Index N neuritis acute 4 neurology 4 O operating conditions 11 operation 8 original packing 14 output frequency 15 output voltage 15 P parapareses 4, 4 plus/minus keys 7 power switch 7 pregnancy 4 protection class 15 pulled muscles 4 R Raynaud s symptomatology 4 reactive effusions 4 S sacralgias 3 service 13 service life 14 soft tissue injuries 4 spondylitides 3 sports injuries 4 sports medicine 4 sprains 4 start-up 8 start/stop key 7 storage temperature 10 Sudeck s syndrome 4 surgery 4 T technical data 15 tissue lesions 4 transport 14 treatment 11 W wave form 15 weight 15 FRIGOSTREAM 19