Riester - Medical devices of the highest standards
User Manual for Riester models including: 13216 Diagnostic Stethoscopes, 13216, Diagnostic Stethoscopes, Stethoscopes
2 days ago — IFU. Contact information for Riester sales and dsitribution partners can be pro- vided upon request. Please note all instruments described in these instructions.
prieš 6 dienas — 1.3 Packaging symbols. 1.4 Purpose. Stethoscopes are sound-conducting devices ... User manual, stethoscopes. 7. Maintenance/accuracy check/calibration. Riester ...
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DocumentDocumentStethoscopes Gebrauchsanweisung Diagnostische Instrumente Instructions Diagnostic Instruments Mode d' emploi Instruments de diagnostiques Instrucciones para el uso Instrumentos diagnósticoss Istruzioni per I' uso Presidi diagnostici ENGLISH Table of Contents 1. 1.1 1.2 1.3 1.4 1.4.1 1.4.2 1.4.3 1.4.4 1.4.5 1.4.6 1.5 2. 2.1 2.2 3. 3.1 3.2 3.3 4. 4.1 4.2 5. 6. 7. 8. 9. Introduction Important information prior to use Safety symbols Packaging symbols Purpose Indications Contraindications Intended patient population Intended operators/users Required skills/operator training Environmental conditions Warnings/caution First use Scope of delivery Device function Operation and function Symbol identification Startup Replacing diaphragms Care instructions General information Cleaning and disinfection Technical specifications Spare parts and accessories Maintenance/accuracy check/calibration Disposal Warranty 1. Introduction 1.1 Important information prior to use You have purchased a high-quality Riester device, which was manufactured in compliance with Regulation (EU) 2017/745 and is subject to the strictest quality controls at all times. Read through these instructions for use carefully before using the device and keep them in a safe place. If you have any questions, we are available at any time, and our contact information is provided at the end of this IFU. Contact information for Riester sales and dsitribution partners can be provided upon request. Please note all instruments described in these instructions for use may only be used by appropriately trained personnel. The safe functioning of this device is only guaranteed if Riester original parts and accessories are used. 2 1.2 Safety symbols Symbol Note on symbol The operator is obliged to read the instructions of the operating manual Meaning of the symbol on the outer packaging: The stethoscopes are latex-free. MD Medical device Warning! The general warning symbol indicates a potentially dangerous situation that can lead to serious injuries. Caution! The caution symbol indicates a potentially dangerous situation that can lead to minor or moderate injuries. The symbol may also indicate unsafe practices. Do not use in an MR environment! Date of manufacture YYYY-MM-DD / (Year-Month-Day) Manufacturer Manufacturer`s batch number °C °F Temperature requirements for transport and storage Relative humidity for transport and storage CE Mark 1.3 Packaging symbols Symbol Note on symbol Fragile. The package should be handled with care. Keep the package from getting wet This way up. The symbol indicates the correct positioning for transporting the package. Keep away from sunlight ,,Green Dot" (country-specific) 1.4 Purpose Stethoscopes are sound-conducting devices for listening to body sounds, particularly from the heart and lungs, and for diagnosing diseases of internal organs. In medicine, a stethoscope is used by clinicians to assess tones and sounds that arise in connection with activity of the heart, lungs and intestines. When measuring blood pressure, a stethoscope is used to detect the Korotkov sounds to determine systolic and diastolic blood pressure. The Riester stethoscope product portfolio offers the full range of options for perfect auscultation in adults, children, infants and newborns. 3 1.4.1 Indications In medicine, trained clinicians use a stethoscope to assess tones and sounds that arise in connection with the activity of the heart, lungs and intestines. When measuring blood pressure, a stethoscope is used to detect the Korotkov sounds to determine systolic and diastolic blood pressure. Riester stethoscopes are used on adults, children, infants and newborns. The stethoscope is used in cardiology/general medicine to diagnose diseases and assess their course. Cardiac auscultation is part of the physical examination and is used to record physiological heart tones and to detect pathological heart murmurs that may be present. Indicating pathological changes in heart valves, for example. When auscultating, it is advisable to simultaneously palpate the pulse at the radial artery, so that a possible pulse deficit (discrepancy between heart rate and pulse rate, e.g. in the context of arrhythmia, cardiac insufficiency or vascular stenosis), as well as the definitive classification of a systolic or a diastolic murmur, can be determined. Lung auscultation is used to detect breathing sounds and secondary breathing noises that arise in the thoracic region. Auscultation is usually done with a stethoscope. It is part of the physical examination. Lung auscultation makes it possible to detect pathological changes in the lungs with simple means and thus obtain signs and symptoms leading to further diagnostic measures. In the stethoscope tube, a column of air is created between the membrane of the chestpiece and the eardrums, which transmits the sound directly from the membrane to the eardrums. The ear tips attached to the head section seal the ear canal and prevent the sound waves from escaping and noise from entering. The sound amplification is achieved by a funnel embedded in the chestpiece. In the case of stethoscopes with a double-headed chestpiece, the chestpiece can be rotated by 180°. In addition to the diaphragm, there is a bell without a diaphragm. It enables better perception of lower frequencies, which can be particularly useful in cardiology. Special chestpiece construction makes it possible to isolate different frequency ranges by modifying the contact pressure of the membrane. When pressed lightly, the lower frequencies are emphasised; when pressed harder, the higher-frequency sound waves are emphasised. 1.4.2 Contraindications A different or broader use is not intended. The manufacturer is not liable for any damages resulting from such. The user bears the sole risk. 1.4.3 Intended patient population The stethoscopes are intended for all patients. In order to optimally examine different body sizes (neonate, baby, adult), the stethoscopes are available in different sizes. 1.4.4 Intended operator/user The stethoscopes are designed for outpatient and inpatient examinations and are for use by doctors/trained personnel in hospitals, medical institutions, clinics, and doctor`s offices. 1.4.5 Required skills/operator training The user must have the qualifications of a doctor or a medically trained clinician (e.g. nurse). Stethoscopes are a common instrument in medicine. 1.4.6 Environmental conditions The device is intended to be used in a controlled environment (hospitals, medical institutions, clinics). The device must not be exposed to adverse/harsh environmental conditions. 1.5 Warnings/caution Do not use in an MR environment! Clean the ear tips regularly and check for free passage. Never place the stethoscope in liquids! 4 The item is not approved for machine reprocessing and sterilization. This will lead to irreparable damage! Phenol-based disinfectants must not be used to clean and disinfect the stethoscopes. The pH of the treatment solution used must be between 4.5 and 10. Never use stethoscopes without ear tips/diaphragms! The ear tips must not penetrate too far into the ear canal! All serious incidents related to the product must be reported to the manufacturer and the competent authority of the Member State in which the user and/or the patient is resident. 2.First use 2.1 Scope of delivery cardiophon 2.0 No. 4240-01 black No. 4240-04 burgundy red No. 4240-03 blue - User manual - 2 pairs of spare ear tips - 1 spare diaphragm Ø 44 - 1 spare diaphragm Ø 32 - 1 name tag duplex 2.0 stainless steel No. 4210-01 black No. 4210-02 white No. 4210-03 blue No. 4210-04 red No. 4210-05 green Aluminium No. 4200-01 black No. 4200-02 white No. 4200-03 blue No. 4200-04 red No. 4200-05 green No. 4201-01 black edition - User manual - 1 pair of spare ear tips - 1 spare diaphragm - 1 name tag duplex® 2.0 baby No. 4220-02 white No. 4220-04 red No. 4220-05 green No. 4220-01 black - User manual - 1 pair of spare ear tips - 1 spare diaphragm - 1 name tag duplex® 2.0 neonatal No. 4230-02 white No. 4230-04 red No. 4230-05 green No. 4230-01 black - User manual -1 pair of spare ear tips -1 spare diaphragm -1 name tag Aluminium chestpiece 5 duplex® No. 4001-01 black No. 4001-02 slate grey No. 4031-03 blue No. 4033-05 green Chromed brass chestpiece No. 4011-01 black No. 4011-02 slate grey No. 4011-03 blue No. 4011-05 green - User manual - 1 pair of spare ear tips - 1 spare diaphragm duplex® baby No. 4041 blue - User manual - 1 pair of spare ear tips - 1 spare diaphragm duplex® neonatal No. 4051 blue - User manual - 1 pair of spare ear tips - 1 spare diaphragm duplex® teaching stethoscope No. 4002-02 slate grey - User manual - 2 pairs of spare ear tips - 1 spare diaphragm tristar® No. 4091 slate grey No. 4093 blue - User manual - 2 pairs of spare ear tips - 1 spare diaphragm Ø 48 - 1 spare diaphragm Ø 36 - 1 spare diaphragm Ø 28 - 1 name tag anestophon No. 4177-01 black No. 4177-02 slate grey No. 4177-03 blue - User manual - 1 pair of spare ear tips - 1 spare diaphragm ri-rap® Tubing length 40 cm No. 4150-01 black No. 4150-03 blue Tubing length 80 cm No. 4155-01 - User manual - 2 pairs of spare ear tips - Bell Ø 33.5 mm, 27.3 mm, 20.3 mm - 1 spare diaphragm Ø 45 - 1 spare diaphragm Ø 32 pinard No. 4190 plastic No. 4191 aluminium 6 2.2 Device function All stethoscopes manufactured by Rudolf Riester have the same basic structure. The stethoscope consists of four elements: 1. Tubing 2. Binaural tubes 3. Ear tips 4. Chestpiece 3. Operation and function 3.1 Symbol identification cardiophon 2.0, duplex® 2.0, duplex® 2.0 baby, duplex® 2.0 neonatal: The opened diaphragm outlet can be recognized immediately by the marking on the tubing connection above. 3.2 Startup 3.2.1 Low/high frequencies: duplex®, duplex® baby, duplex® neonatal, tristar®, ri-rap®: Rotating the chest piece selects the diaphragm side (high frequencies) or the bell side (low frequencies). It is essential to ensure good surface adaptation during auscultation. When measuring blood pressure, the chestpiece can be partially pushed under the cuff with the diaphragm side down. You can immediately see which side is active from the closed/open bell outlet. After putting on the Binaural tubes, you can recognize acoustically whether the diaphragm is active by gently tapping the diaphragm. With the ri-rap® model, the small diaphragm side can optionally be converted into an open bell. The different bell sizes can be found in the enclosed spare parts list. 3.2.2 Adjusting/putting on the Binaural tubes duplex®, duplex® baby, duplex® neonatal, tristar®, anestophon®, ri-rap®: Fig. A. Please ensure that the Binaural tubes are set to the anatomically correct angle, i.e. they are to be worn so that they point slightly forward (see Fig.A). Fig. B The angle can be adjusted individually by rotating the Binaural tubes. The ear tips are correctly positioned when they are perfectly aligned with the external auditory canal which optimally prevent distracting external noise. The soft Riester ear 7 tips are particularly suitable for this. If the contact pressure of the Binaural tubes is too strong or too weak, proceed as follows: If the contact pressure is too weak, press the two Binaural tubes together, as shown in Fig. B. If the contact pressure is too strong, spread the two Binaural tubes apart, as shown in Fig.C. 3.2.3 cardiophon 2.0, duplex® 2.0, duplex® 2.0 baby, duplex® 2.0 neonatal Fig. C The Binaural tubes are anatomically correctly set at the factory; their contact pressure is individually adjustable (Figs. B and C), the ear tips are rotatable and made of an extra-soft material. Overall, this achieves a perfect seal of the ear canal against external noises, and prevents noise from the ear tips rubbing against the ear, even while the stethoscope is moving. The ear tips must not penetrate too far into the ear canal! 3.3 Replacing diaphragms 3.3.1 duplex®, duplex® baby, duplex® neonatal, tristar®, anestophon®, rirap®: duplex®, duplex® baby, duplex® neonatal, tristar®, anestophon®, ri-rap®: To change the diaphragm, take the non-chill rim between your thumb and forefinger and pull it off the chestpiece. Place the non-chill rim with the flat side down on a flat surface and insert the diaphragm into the non-chill rim with the printed side facing up. Take the non-chill rim with the diaphragm and press it onto the chestpiece. With the ri-rap® chestpiece, the diaphragm is inserted into the threaded ring and the threaded ring is screwed back on. In the case of diaphragms with a curvature, this should point outwards, away from the ri-rap® chestpiece. 3.3.2 cardiophon 2.0, duplex® 2.0, duplex® 2.0 baby, duplex® 2.0 neonatal To change the diaphragm, take the non-chill rim between your thumb and forefinger and pull it off the chestpiece. Place the new diaphragm with the printed side up centered in the opening of the chestpiece, then place the non-chill rim in the centered position and press it back onto the chestpiece with your thumbs in a semicircular movement. Please ensure that the diaphragm remains centered in the opening and is not shifted. 4. Care Instructions 4.1 General Information The cleaning and disinfecting of medical devices serves to protect the patient, user, and third parties, and to maintain the value and function of the medical device. The product design and materials used make it impossible to define an upper limit on max. feasible treatment cycles. The service life of medical devices is determined by their function and proper handling. Before return for repair, defective products must have undergone the prescribed reprocessing procedure. If a reusable device shows signs of material deterioration, it should no longer be used and should be disposed of/claimed according to the procedures described in the disposal/warranty sections. 4.2 Cleaning and disinfection To avoid possible cross-contamination, the stethoscope must be cleaned and disinfected regularly. The outside of the device can be cleaned with a damp cloth (if necessary, moistened with alcohol) until they are visually clean. Use disinfectants (e.g. disinfectant Bacillol AF by the company Bode Chemie GmbH / time 30s) only as per the manufacturer`s specifications. Only disinfectants with proven effectiveness according to national directives should be used. After disinfection, please wipe the devices with a damp cloth to remove any residual disinfectant. Please make sure that the cloth is moistened, NOT8wet, to prevent moisture from entering the device openings. For this, the non-chill rims and membrane(s) must be removed from the chestpiece. Take the non-chill rim between your thumb and forefinger and pull it off the chestpiece. The loose membrane can then be removed from the chestpiece. With the ri-rap® chestpiece, the threaded rings are unscrewed for this. For thorough cleaning and disinfection of the ear tips, these can be pulled off (unscrewed in the case of the ri-rap). For thorough cleaning and disinfection, you can use 70% isopropyl alcohol or soapy water to wipe the chestpiece, the non-chill rims the membrane(s), the ear tips and Binaural tubes with tubing. After cleaning and disinfection, the parts must be dried thoroughly before assembly. Then attach or screw the ear tips back onto the Binaural tubes. duplex®, duplex® baby, duplex® neonatal, tristar®, anestophon®, ri-rap®: Place the non-chill rim with the flat side down on a flat surface and insert the diaphragm into the non-chill rim with the printed side facing up. Take the nonchill rim with the diaphragm and press it onto the chestpiece. With the ri-rap® chestpiece, the diaphragm is inserted into the threaded ring and the threaded ring is screwed back on. In the case of diaphragms with a curvature, this should point outwards, away from the ri-rap® chestpiece. cardiophon 2.0, duplex® 2.0, duplex® 2.0 baby, duplex® 2.0 neonatal: Place the diaphragm with the printed side up centered in the opening of the chest piece, position the non-chill rim correctly, and press it back onto the chestpiece with your thumbs, each in a semicircular motion. Please ensure that the diaphragm remains in its opening and is not off-center. When using 70% isopropyl alcohol, ensure the room is well ventilated! Do not use in the vicinity of fire-triggering devices or fire. Regularly clean and disinfect the ear tips and check for free passage. Never place the stethoscope in liquids! The item is not approved for machine reprocessing and sterilisation. This will lead to irreparable damage! Phenol-based disinfectants must not be used to clean and disinfect the stethoscopes. The pH of the treatment solution used must be between 4.5 and 10. Never use stethoscopes without ear tips/diaphragms! 5. Technical specifications Operating conditions: 10°C / 50°F to 40°C / 104°F with a relative humidity of 30% to 70% (non-condensing) 700 hPa to 1060 hPa Storage conditions: -10°C / 14°F to 55°C / 131°F with a relative humidity of 85% (non-condensing) 6. Spare parts and accessories Item no. 13216 Binaural tubes with ear tips and tubing, burgundy, cardiophon 2.0 Item no. 13220 Binaural tubes with ear tips and tubing, black, cardiophon 2.0 Item no. 13222 Binaural tubes with ear tips and tubing, blue, cardiophon 2.0 Item no. 13223 Binaural tubes with ear tips and tubing, black, duplex® 2.0 Item no. 13224 Binaural tubes with ear tips and tubing, white, duplex® 2.0 Item no. 13225 Binaural tubes with ear tips and tubing, blue, duplex® 2.0 Item no. 13226 Binaural tubes with ear tips and tubing, red, duplex® 2.0 Item no. 13227 Binaural tubes with ear tips and tubing, green, duplex® 2.0 Item no. 13228 Binaural tubes with ear tips and tubing, black, duplex® 2.0 Item no 11065-01 Binaural tubes with Y-tubing, black, duplex®, anestophon Item no. 11065-02 Binaural tubes with Y-tubing, slate grey, duplex®, anestophon Item no. 11060-03 Binaural tubes with Y-tubing, blue, duplex®, anestophon Item no. 11061-01 Binaural tubes with Y-tubing, green, duplex®, anestophon 9 Item no. 11068-02 Binaural tubes with Y-tubing, slate grey, tubing connector, tristar Item no. 11068-03 Binaural tubes with Y-tubing, blue, tubing connector, tristar Item no. 11070-01 Binaural tubes with double tubing, black, ri-rap 40 cm Item no. 11070-03 Binaural tubes with double tubing, blue, ri-rap 40 cm Item no. 11071-01 Binaural tubes with double tubing, black, ri-rap 80 cm Item no. 11071-03 Binaural tubes with double tubing, blue, ri-rap 80 cm Binaural tubes with ear tips, without tubing Item no. 11080 Binaural tubes duplex®, anestophon Item no. 11083 Binaural tubes ri-rap Chestpieces Item no. 13229 Item no. 13230 Item no.1 3231 Item no. 13232 Item no. 13233 Item no. 13234 Item no. 11008 Item no. 11010 Item no. 11015 Item no. 11018 Item no. 11035 Item no. 11036 Item no. 11038 Item no. 11027 Item no. 11032 Double chestpiece stainless steel, cardiophon 2.0 Double chestpiece aluminium silver, duplex® 2.0 Double chestpiece stainless steel, duplex® 2.0 Double chestpiece aluminium black, duplex® 2.0 Double chestpiece stainless steel, duplex® 2.0 baby Double chestpiece stainless steel, duplex® 2.0 neonatal Double chestpiece aluminium, duplex® Double chestpiece chromed, duplex® Double chestpiece aluminium, duplex® baby Double chestpiece aluminium, duplex® neonatal Double chestpiece aluminium adult, tristar Double chestpiece aluminium children, tristar Double chestpiece aluminium infants, tristar Double chestpiece chromed, ri-rap Single chestpiece aluminium, anestophon Ear tips Item no. 11139 Item no. 13235 Item no. 11110 Item no. 11107 Item no. 11106 Item no. 111018 10 pairs of ear tips soft, grey, cardiophon, duplex® (de luxe), anestophon, tristar 10 pairs of ear tips, soft, black, cardiophon 2.0, duplex® 2.0 10 pairs of ear tips hard, white, duplex® (de luxe), anestophon, tristar 10 pairs of ear tips large, black, hard, ri-rap 10 pairs of ear tips small, black, soft, ri-rap 10 pairs of ear tips large, clear, soft ri-rap Printed diaphragms Item no. 11042 Pack of 10 diaphragms Ø 45 mm, cardiophon, duplex® (de luxe), anestophon, tristar Item no.11050 Pack of 10 diaphragms Ø 34 mm with hole, cardiophon®, duplex® de luxe Item no. 11052 Pack of 10 diaphragms Ø 34 mm, duplex® (de luxe) baby, tristar Item no. 13236 Pack of 10 diaphrams Ø 44 mm, cardiophon 2.0, duplex® 2.0 Item no. 13237 Pack of 10 diaphragms Ø 32 mm, drilled out cardiophon 2.0, Item no. 11051 Pack of 10 diaphragms Ø 26 mm, duplex® (de luxe) neonatal, tristar Item no. 13238 Pack of 10 diaphragms Ø 32 mm, duplex® 2.0 baby Item no. 13239 Pack of 10 diaphragms Ø 24 mm, duplex® 2.0 neonatal Item no. 11048 Pack of 10 diaphragms Ø 27.5 mm, ri-rap Item no. 11049 Pack of 10 diaphragms large Ø 40.5 mm, ri-rap Non Chill Rims Item no. 13240 Item no. 13241 Item no. 11140 Item no. 11141 Item no. 11143 Item no. 11144 Non Chill Rims Ø 52 mm black, cardiophon 2.0, duplex 2.0 Non Chill Rims Ø 38 mm black, cardiophon 2.0, duplex 2.0 Non Chill Rims Ø 48 mm grey, duplex® (de luxe), tristar Non Chill Rims Cold protection ring Ø 35.8 mm grey, cardiophon, duplex® (de luxe) and baby, tristar Non Chill Rims Ø 28 mm grey, duplex® (de luxe) baby, neonatal, tristar Non Chill Rims Ø 22 mm grey, duplex® (de luxe) neonatal, tristar Other accessories Item no. 11120 Spare parts box complete, ri-rap Item no. 11122 Pack of 10 bell attachments large, ri-rap Item no. 11124 Pack of 10 bell attachments medium, ri-rap Item no. 11123 Pack of 10 bell attachments small, ri-rap Name plate 10 Item no. 11147 Pack of 10 name plates Product user manual Instructions for use for all stethoscopes except pinard Item no. 99209 User manual, stethoscopes 7. Maintenance/accuracy check/calibration Riester stethoscopes and accessories do not require special maintenance. If the stethoscope needs to be checked for any reason, please send it to us or an authorized Riester dealer in your area, the details of which we will provide upon request. 8. Disposal Caution! The used medical device must be disposed of in accordance with current medical practices or local regulations on the disposal of infectious biological medical waste. Batteries and electrical/electronic devices may not be treated as domestic waste and must be disposed of in accordance with local regulations. If you have questions about the disposal of products, please contact the manufacturer or their representative. 9. Warranty This product has been manufactured under the strictest quality standards and has undergone a thorough final quality check before leaving our factory. We are therefore pleased to be able to provide a warranty of 2 years from the date of purchase on all defects, which can verifiably be shown to be due to material or manufacturing faults. A warranty claim does not apply in the case of improper handling. All defective parts of the product will be replaced or repaired free of charge within the warranty period. This does not apply to wearing parts. For r1 shock-proof, we grant an additional warranty of 5 years for the calibration, which is required by CE-certification. A warranty claim can only be granted if this Warranty Card has been completed and stamped by the dealer and is enclosed with the product. Please remember that all warranty claims have to be made during the warranty period. We will, of course, be pleased to carry out checks or repairs after expiry of the warranty period at a charge. You are also welcome to request a provisional cost estimate from us free of charge. In case of a warranty claim or repair, please return the Riester product with the completed Warranty Card to the following address: Rudolf Riester GmbH Dept. Repairs RR Bruckstr. 31 72417 Jungingen Germany Serial number or batch number, date, stamp and signature of the specialist dealer 12 Rudolf Riester GmbH P.O. Box 35 | Bruckstrasse 31 | 72417Jungingen | Germany Tel.: (+49) 7477-9270-0 | Fax.: (+49) 7477-9270-70 E-Mail: info@riester.de | www.riester.de 99209 Rev.G 2021-04 · Änderungen vorbehalten · Subject to alterations · Sous réserve de modifications · Sujeto a modificaciones · Con riserva di apportare modifiche ·