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BIOTRONIK Reocor S, Техническое руководство, Страница: 4 / 42

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Contents

General Description  .................................................................................3

Product Description  ...................................................3

Indications ..................................................................3

Contraindications .......................................................4

Potential Side Effects  .................................................4

Handling Instructions .................................................4

Visual and Acoustic Signals  .......................................8

Operating Notes  .......................................................................................9

General Remarks  .......................................................9

Operating Devices and LEDs .................................... 10

Protective Cover  ....................................................... 11

Lead Connection  ...................................................... 12

Start Up  .................................................................... 19

Attachment ............................................................... 19

Battery Exchange  ..................................................... 20

Pacing Modes and Parameters ...............................................................22

Pacing Modes  ........................................................... 22

Rate .......................................................................... 22

Pulse Amplitude and Pulse Width  ........................... 23

Sensitivity ................................................................. 23

Interference interval  ................................................ 23

Burst ......................................................................... 23

Handling, Care and Maintenance ............................................................25

Reocor S  ................................................................... 25

Reusable Patient Cables  .......................................... 26

Maintenance, Service, Inspections  .......................... 26

Disposal .................................................................... 27

Technical Safety  .....................................................................................28

Technical Data ........................................................................................29

Conformity According to IEC 60601-1-2  .................................................32

Scope of Delivery and Accessories  .........................................................36

Legend for the Label  ..............................................................................38

394270--J_GA_Reocor_S_mul.book  Page 1  Monday, January 26, 2015  4:39 PM

Содержание Reocor S

Страница 1: ...aszn lati utas t s Manuale tecnico Technische handleiding Instrukcja obs ugi Manual t cnico en cs de es fr hu it nl pl pt External pacemaker Extern kardiostimul tor Externer Herzschrittmacher Marcapas...

Страница 2: ...Fran ais English esky Espa ol Italiano Nederlands Polski Portugu s Magyar Deutsch 394270 J...

Страница 3: ......

Страница 4: ...ices and LEDs 10 Protective Cover 11 Lead Connection 12 Start Up 19 Attachment 19 Battery Exchange 20 Pacing Modes and Parameters 22 Pacing Modes 22 Rate 22 Pulse Amplitude and Pulse Width 23 Sensitiv...

Страница 5: ...2...

Страница 6: ...ched on is indicated by continuously lit LEDs and an intermittent acoustic signal If the self test does not find any errors the acoustic and visual signals will turn off after a few seconds The safety...

Страница 7: ...leads include Wound infection arterial puncture pericardial friction cardiac perforation and dysrhythmia after lead insertion Handling Instructions Depending on the pacing settings and the patient s...

Страница 8: ...the patient cable or leads the user should touch the patient to equalize electrical potentials It is strongly recommended to examine all set para meters before the leads are connected to Reocor S Eve...

Страница 9: ...subjected to a function test If the device will be stored for a long period of time the battery should be removed to prevent damage due to leakage A damp cloth and mild soap can be used for cleaning S...

Страница 10: ...off and then on again so that the device can perform a complete self test Additionally after defibrillation the pacemaker function and pacing threshold must be checked and monitored for a sufficient...

Страница 11: ...ignals sound A required battery replacement is indicated by the flash ing red Low battery LED The Sense green LED signals sensing of a P wave or R wave The Pace yellow LED signals pulse delivery The L...

Страница 12: ...pulses in accordance with the programmed parameters The nega tive electrode cathode should therefore only be connected when it has been ensured that the pacing mode pacing rate pulse amplitude and se...

Страница 13: ...10 Operating Devices and LEDs Figure 1 Reocor S operating panel...

Страница 14: ...t function 9 Velcro harness Secures Reocor S to patient bed or infusion stand 10 Burst rate control dial Setting the burst rate 11 Select burst Selection of the burst function 12 Rate control dial Set...

Страница 15: ...the stop and then remove it Caution During use of Reocor S the protective cover must be locked to prevent inadvertent resetting of the rotary switch and con trol dial and thus of the programmed param...

Страница 16: ...bles and adapters Patient cable PK 83 B with two screw terminals for tem porary leads on the patient side and Redel plug on the Reocor S side use the Redel adapter Figure 5 Patient cable PK 83 B Patie...

Страница 17: ...connection for the adapter according to Figure 13 and for the single use cable according to Figure 9 Figure 8 Patient cable PK 67 L and PK 67 S Cable for single use The single use cables Remington 30...

Страница 18: ...possible Patient cable PK 141 with 4 alligator clips on the patient side and Redel plug on the Reocor S side use the Redel adapter The ventricular channel is indicated by the label Vent Diff Indiff o...

Страница 19: ...tion WARNING Danger to patient by damaged cables Damaged cables are limited in functionality and pose a danger to patients Do not use damaged cables WARNING Danger from loss of function Damp cables ha...

Страница 20: ...dapter Connection Variants Temporary catheters with 2 mm plugs or heart wire with 2 mm adapter You have the option to connect Reocor S directly to a tempo rary catheter with touch proof 2 mm plug or t...

Страница 21: ...e side connection Reocor S connection Recommended connections Screw terminals PK 83B Redel plug Redel adapter Screw terminals PK 83 2 mm plug 2 mm connector port Possible connections Screw terminals P...

Страница 22: ...Low battery LED 3 flashes the battery needs to be replaced for battery exchange see page 20 Connect leads the yellow Pace LED 4 flashes in syn chrony with the pacing pulses Set the sensitivity with t...

Страница 23: ...rature 20 2 C when the battery is removed For safety reasons the patient should be paced by another source during the battery replacement Do not use rechargeable batteries The service time of these ba...

Страница 24: ...igure 14 down first into the battery compartment Figure 14 Inserting the battery Close the drawer and press the blue slider down until it snaps in place with an audible click Note If the pacemaker is...

Страница 25: ...ion no pulse inhibition takes place upon sensing of an event outside of the refractory period instead pulse delivery is carried out immediately in the respective chamber High frequency pacing The rate...

Страница 26: ...t the pro grammed rate for as long as the interference lasts Burst The rate of the atrial Burst rate function can be selected with the control dial 10 between 60 ppm and 1000 ppm This function is acti...

Страница 27: ...entricular tachycardia or fibrillation This can be caused by poor placement of the leads or the presence of anomalous stimulus conduction paths that circumvent the normal atrio ventricular stimulus co...

Страница 28: ...her horizontally on a non slip surface or on the patient with an armband or operate it from a hanging position on the infusion stand using the hanger on the back of the device Caution Reocor S must no...

Страница 29: ...n accordance with the man ufacturer information and in accordance to the respective hospital guidelines After disinfection the cable must be cleaned from residues of the disinfectant by rinsing it in...

Страница 30: ...ymbol indicates that the European guideline 2002 96 EC on waste electrical and electronic equipment WEEE directive applies to the disposal method of the device Old devices and accessories that are no...

Страница 31: ...ng and is approved for direct treatment of the heart The pacemaker complies with the require ments for defibrillation protection stipulated in the inter national standards The closed protective cover...

Страница 32: ...r Deutsch Technical Data Symbols Follow the instructions for use in the technical manual Indication of the placement of the battery in the compartment Disposal according to the WEEE directive Applied...

Страница 33: ...the battery type MN 1604 Duracell Procell End of service EOS Flashing Low battery LED Remaining service time after ERI signalb Behavior during battery exchange Ambient conditions Temperature range fo...

Страница 34: ...rial Babyblend FR 3000 PC ABS Classification Applied part classification CF cardiac floating defibrillation protected Safety class II b Protection degree IP31 water repellent Defibrillation proof leve...

Страница 35: ...Emission of harmonic oscillations according to IEC 61000 3 2 Not applicable Voltage fluctuations according to IEC 61000 3 3 Not applicable Manufacturer guidelines and declaration resistance to electr...

Страница 36: ...ld correspond to the typical value in business and hospital environ ments Test of resistance to interference Testlevelaccordingto IEC 60601 Compliance level Guidelines for the electro magnetic environ...

Страница 37: ...range 80 MHz to 2 5 GHz is designed to reduce the likelihood that mobile communica tion devices cause interference if they are unintentionally brought into the patient area For this reason a greater s...

Страница 38: ...50 12 00 12 00 23 00 For transmitters whose rated power is not specified in the table above the safe distance can be calculated using the specified formula for the corresponding frequency Here P is t...

Страница 39: ...2 0 m Remington Medical Inc Cabo do paciente dois fios com terminais rosque veis para uso nico Adaptador para ADAP 2R apenas para EUA PK 141 2 8 m 353181 Cabo do paciente reesteriliz vel com quatro c...

Страница 40: ...RONIK N mero de s rie do aparelho Data de fabrica o do aparelho Varia o de temperatura de armazenamento permitida Varia o de press o atmosf rica de armazenamento permitida Varia o de umidade do ar de...

Страница 41: ...398...

Страница 42: ...689 2804 sales biotronik com www biotronik com Fornecedor BIOTRONIK Comercial M dica Ltda Rua dos Inocentes 506 04764 050 S o Paulo SP Tel 55 11 5694 7755 Fax 55 11 5694 7770 CNPJ 50 595 271 0001 05...

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