Riester Laryngoscopes Standard and Fiber Optic Instructions Rev B

1. Important information to be read prior to first-time use You have purchased a high-quality RIESTER product, which is manufactured in compliance with Directive 93/42/EC for medical products and is subject to continuous stringent quality controls. This outstanding quality guarantees reliability in use. These Instructions for Use are applicable for both fiber optic (xenon) and standard illumination (vacuum) laryngoscopes. Should you have any queries, please contact us or your authorised RIESTER dealer for assistance. Our address can be found on the last page of these Instructions for Use. The address of your RIESTER dealer will be supplied upon request. Please note that all instruments described in these Instructions for Use are only suitable for use by trained operators. Test the condition of the internal electrical energy source each time before use by turning on the lamp. Furthermore, please note that the correct and safe functioning of our instruments is only ensured when RIESTER instruments and accessories are used throughout.

2. Battery handles and first-time use 2.1. Purpose The RIESTER battery handles described in these Instructions for Use serve to supply the lamps with power and to act as blade holders. 2.2. Battery handle range a) Battery handle type C 28 mm diameter, 2.5 V for standard and fiber optic laryngoscopes In order to operate these battery handles, you will require two commercially available 1.5 V type C alkaline batterries (IEC standard designation LR14) or one 2.5 V or 3.5 V rechargeable battery (ri-accu®). The handle with the rechargeable RIESTER battery (ri-accu®) can only be charged in a RIESTER ri-charger® charging base. b) Battery handle type AA 19 mm diameter, 2.5 V for standard and fiber optics laryngoscops In order to operate this battery handle, you will require two comercially available 1.5 V type AA Mignon alkaline batteries (IEC standard designation LR6) or a 2.5 V rechargeable battery (ri-accu®). 13

Safety: Application part type B Remarks concerning electromagnetic compatibility: At present, there is no indication that electromagnetic interactions with other equipment arise when these instruments are used as directed. Nevertheless, interference may not be completely ruled out under the increased influence of unfavourable field strengths, e.g. due to mobile telephones and radiological instruments. 2.3. Insertion and removal of batteries and rechargeable batteries Handle types 2.2 a and b Remove the handle cover from the bottom of the handle by twisting. Insert either two batteries (as described in 2.2) or one 2.5 V or 3.5 V RIESTER rechargeable battery (ri-accu®) into the handle sleeve, with the positive terminals pointing towards the top of the handle. The rechargeable battery (ri-accu®) is also marked with an arrow next to the plus sign, pointing in the direction in which it should be inserted into the handle. Twist the handle cover firmly back into place on the handle. Batteries or rechargeable batteries (ri-accu®) are removed by first removing the battery handle cover. In order to remove the batteries or rechargeable battery, shake the handle slightly in a downward direction. Prior to the first-time use of rechargeable handles, first place the rechargeable battery (ri-accu®) into the handle and charge up the handle in the RIESTER ri-charger® charging base. The charging base includes additional instructions for use which have to be observed. Warning: • When placing the ri-accu® into the rechargeable handle, ensure that the battery handle cover is open. • Should the instrument not be used for a longer period of time or whilst travelling, remove the batteries or the rechargeable battery from the handle. • In the case of certain rechargeable batteries, the voltage may drop quickly when in use and this can lead to a rapid decrease in light intensity. 14

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Insert new batteries when the light intensity of the instrument is low, which can affect its efficiency in use. • For maximum light yield we recommend that only new, high quality batteries are fitted when replacing batteries (as described in 2.2). • If you suspect that liquid or condensation has penetrated inside the handle, do not recharge it under any circumstances. • Always ensure that the correct handle for standard and fiber optics blades is used. (Fiber optic handles are marked with a green ring). Disposal Please note that batteries have to be disposed of separately. For details, ask your local authority and/or the responsible environmental consultant. 2.4. Attachment of laryngoscope blades On/Off function Attach the required laryngoscope blade to the runner on the upper part of the handle and pull up the front part of the blade until the back of the blade is in a line with the upper part of the handle. A click will be heard as it snaps into place. As the blade engages, the lamp will be turned on. The lamp is switched off as soon as the blade disengages from the snap attachment. 2.5. Care Cleaning and/or disinfection Battery handles may be cleaned from the outside with a moist cloth. Furthermore, the following disinfectants may be used for disinfection: Aldehydes (formaldehyde, glutaraldehyde, aldehyde derivatives), surfactants or alcoholic solutions. When using these substances, observe the manufacturer's instructions closely. A soft, preferably lint-free cloth or Q-tips may be used as aids for cleaning or disinfecting. Warning Never immerse the handles in liquids. Ensure that no liquid penetrates inside the casing. Never clean batteries and rechargeable batteries with water or aqueous solutions. Sterilisation The battery handle is not intended to be used for invasive procedures. Cleaning and/or disinfecting is fully adequate.

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2.6. Spare parts Rechargeable batteries Article No. 10680 ri-accu® 2.5 V for handle AA, 2.5 V, 19 mm diameter Article No. 10681 ri-accu® 2.5 V for F.O. and standard handles type C 2.5 V, 28 mm diameter Article No. 10682 ri-accu® 3.5 V only for F.O. handles type C XL3.5 V, 28 mm diameter Quality batteries 1.5 V non-rechargeable Article No. 10685 for handles type AA Packs of 4. Article No. 10686 only for handles type C 2.5 V Charging base ri-charger® Article No. 10700 ri-charger® 2.5 V/3.5 V / 230 V, including wall bracket Article No. 10701 ri-charger® 2.5 V/3.5 V / 120 V, including wall bracket

3. Laryngoscope blades 3.1. Purpose The laryngoscopes described in these Instructions for Use have been manufactured for endotracheal intubation. 3.2. Replacement of lamp Standard blade (vacuum illumination): Twist off the lamp at the front of the blade and replace it with a new lamp. Fiber optic blades (xenon illumination): a) Twist off the upper part of the handle from the sleeve. b) Unscrew the lamp holder at the knurl and remove. c) Unscrew the lamp. d) Screw in a new lamp. e) Screw back the lamp holder into the top part of the handle. f) Screw the upper part of the handle into the handle sleeve. 3.3. Detaching/inserting the light conductor ri-modul This is possible by disengaging/engaging the light conductor from the side at the hinge connection of the blade.

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3.4. Technical specifications of lamps Lamp, small, 2.7 V 300 mA average life standard 20 h Lamp, large, 2.7 V 300 mA average life standard 20 h Lamp, XL 2.5 V 680 mA fiber optics average life 20 h Lamp, XL 3.5 V 700 mA fiber optics average life 20 h Warning: Lamps in exposed places, which remain illuminated, can produce heat which is sufficient to burn human tissue. 3.5. Care a) Predisinfection Warning: The lamp should first be removed for standard blades! Always immerse instruments into a non-mercury disinfectant solution immediately after use. This is to prevent the general migration of germs and to protect staff against contamination from germcontaining secretions which adhere to the blade and may constitute a hazard when it is subsequently cleaned. In addition, this prevents drying of any residual blood and secretions which may be difficult to remove completely at a later time. Strictly comply with the manufacturer's instructions relating to solvent concentration and reaction times in order to achieve a pre-disinfecting effect. The following solutions have been tested for material compatibility: Bacillotox, Baktol, Cidex, Gigasept, Ivisol, Korso-lin, Orbiphen. Thoroughly rinse instruments in distilled water after disinfection. b) Cleaning and disinfection Manually Clean instruments immediately after pre-disinfection in soapy water using a soft brush. Rinse the blade well in distilled water and dry with a soft cloth. Mechanically Clean instruments in automatic cleaning and disinfecting equipment. Comply strictly with the manufacturer's instruc-tions regarding concentration of detergents and disinfec-tants and the duration of the washing and drying cycles. Do not exceed 95°C.

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The use of unsuitable detergents and disinfectants, in particular superficial disinfectants, may lead to irreparable damage to the blade and light conductor. c) Sterilisation Laryngoscope blades may be sterilised at 134°C (standard and fiber optics) with 5 minutes residence time in a steam sterilizer; the service life of the light conductor may be affected by high temperatures. • • •

Laryngoscopes should be clean and dry before sterilizaton. The lamps of standard illumination blades should be removed before autoclaving. With frequent autoclaving, the light transmission of fiber optics blades can markedly deteriorate.

Warning! • Flash autoclaving and hot-air sterilization are not permitted! • Do not subject instruments to ultrasonic cleaning! • Prions cannot be deactivated by current techniques used for cleaning, disinfecting and sterilizing (e.g. new variants of the Creutzfeldt-Jakob disease (CJD)). 3.6. Spare parts and accessories Article No. 11380 Pack of 6 lamps, small, 2.7 V, for standard blades Miller No. 00 - 1 Article No. 11381 Pack of 6 lamps, large, 2.7 V, for standard blades Miller No. 2 - 4, Macintosh 0 - 5 Article No. 11428 Pack of 6 lamps, XL, 2.5 V, for all fiber optic blades Article No. 11429 Pack of 6 lamps, XL, 3.5 V, for all fiber optic blades

4. Maintenance These instruments and their accessories do not require any special maintenance. Should an instrument have to be checked for any reason whatsoever, please return it to us or an authorised RIESTER dealer in your area, who we will be pleased to name upon request.

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B lu td ru c k m e s s g e rä te l In s tru m e n te fü r H .N .O ., O phtha lm o lo g is c he Ins trum e nte l D e rm a to lo g is c he Ins trum e nte l T h e rm o m e te r l S te th o s k o p e l S tirn s p ie g e l, S tirn la m p e n , U n te rs u c h u n g s la m p e n l L a ry n g o s k o p e l G y nä k o lo g is c h e Ins trum e nte l P e rk us s io ns hä m m e r l S tim m g a be ln l P ro d uk te z ur B lu ts ta u u n g I L u n g e n d ru c k m e s s g e rä te l D y n a m o m e te r lD ru c k infu s io ns g e rä te l V e te rinä rm e d iz inis c he Ins tru m e nte l A rz tk o ffe r/ - ta s c he n

D ie d e t a illie r t e n B e s c h re ibu n g e n d e r P ro d u k t e fin d e n S ie u n t e r d e r je w e ilig e n R u br ik im G e s a m t k a t a lo g ( B e s t . N r. 5 1 2 3 1 -5 0 ) . O d e r g e h e n S ie o n lin e u n t e r w w w . r ie s t e r. d e . R ie s t e r o ffe r s a la r g e s e le c t io n o f pro d u c t s in t h e a re a s of B lo o d p re s s ure m e a s uring d e vic e s I Ins trum e nts fo r E N T, O p htha lm o lo g ic a l ins trum e nts I D e rm a to lo g ic a l ins trum e nts I T he rm o m e te rs I S te tho s c o p e s I H e a d m irro rs , H e a d lig hts , E x a m ina tio n lig hts I L a ryng o s c o pe s I G yna e c o lo g ic a l ins trum e nts I P e rc us s io n ha m m e rs I Tuning fo rk s I P ro d uc ts fo r blo o d s ta s is I P ulm o na ry p re s s ure m e a s uring d e vic e s I D y na m o m e te rs I P re s s ure infus io n ins trum e nts I Ve te rina ry ins trum e nts I D o c to r’s c a s e s a nd ba g s

D e t a ile d d e s c r ipt io n s o f t h e pro d u c t s c a n be fo u n d in t h e re s pe c t iv e s e c t io n s o f t h e o m n ibu s e d it io n c a t a lo gue (O rde r N o. 5 1 2 3 2 -5 0 ) . Or online unde r w w w . r ie s t e r. d e . Distributed By

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