MicroPort CRM SORIN SPIDER SAS Скачать руководство пользователя страница 60

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MicroPort CRM S.r.l.

Via Crescentino S.N.
13040 Saluggia (VC)

Italy

Tel: +39 0161 487095

www.crm.microport.com

MANUFACTURED IN FRANCE FOR:

US Phone: 877.663.7674

FOR US ONLY - CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

2020-04

U908F

Содержание CRM SORIN SPIDER SAS

Страница 1: ...Spider SAS Apnea Rhythm recorder USER MANUAL...

Страница 2: ......

Страница 3: ...ir of the device 13 Warranty 13 End of Service 14 US Federal Communications Commissions FCC and Industry Canada 14 5 CLEANING 16 Spider SAS and Physio Hub 16 SpO2 Sensor 16 Piezo Effort Sensor for res...

Страница 4: ...Spider SAS 42 Steps to set up and start a Holter recording with Spider SAS 42 11 STARTING RECORDING ANONYMOUS MODE 44 General Description 44 Limitations of use 44 Conditions for Starting a Holter rec...

Страница 5: ...4 Guidance and manufacturer s declaration cable length 54 Guidance and manufacturer s declaration electromagnetic emissions 55 Guidance and manufacturer s declaration magnetic and electromagnetic immu...

Страница 6: ...packaging This icon is used to draw your attention to a particularly important point This icon alerts you to a hazard that may result in equipment damage or per sonal injury Carefully read the instru...

Страница 7: ...shock fire and mechanical haz ards only in AAMI ES 60601 1 2006 A2 2010 and CSA 22 2 NO 60601 1 CAN CSA 2008 This symbol confers the approval of the US Federal Communications Commis sion 1 INTRODUCTI...

Страница 8: ...ycardia detected during a recording Bradycardia threshold values can be defined in the rhythm protocol Bradycardia can only be detected if the mean rate is lower than the threshold value for at least...

Страница 9: ...vals as set for the calculation of Min Max HR If not enough RR values are available 2 values are used VT Periods of ventricular tachycardia detected during a recording Tachycardia threshold s value ca...

Страница 10: ...d on the SD card ready to be easily analyzed by Synescope software version 3 30 or higher with SAS option to provide reports of Sleep Apnea with ECG arrhythmia analysis Spider SAS is indicated for pat...

Страница 11: ...is to record data from various sensors see 3 1 CONTRAINDICATIONS AND SIDE EFFECTS There are no contraindications or side effects associated to the use of Spider SAS and its accessories 3 2 3 3 3 SPID...

Страница 12: ...partment or on the electrical contacts remove the battery and dispose of it following local environmental legislation and or the intended procedures If the leak is not significant no oxidation on the...

Страница 13: ...d for Spider SAS Physio Hub and their accessories However should the device fail to work properly or if plastic enclosure is broken after mechanical shock for example contact your local MicroPort affi...

Страница 14: ...eparation distance between the equipment and receiver Connect the equipment to an outlet on a circuit different from that to which the receiver is connected Consult the dealer or an experienced radio...

Страница 15: ...positif Conform ment la r glementation d Industrie Canada le pr sent metteur radio peut fonctionner avec une antenne d un type et d un gain maximal ou inf rieur approuv pour l metteur par Industrie Ca...

Страница 16: ...tens the life of cables and causes an important internal oxidation between the clip and the wire of the cable The quality of the ECG signal could be affected SPO2 SENSOR Reusable PureLight Sensor is m...

Страница 17: ...ity with medical devices is clearly mentioned on their packaging and needs to be respected NOTE Quaternary ammonium associated with nonionic surfactants is the best solution alcohol free cleaner for p...

Страница 18: ...the SD card CAUTION Never put Spider SAS Physio Hub and active sensors in a liquid or a disinfectant solution Never put Spider SAS and its accessories in an autoclave Do not sterilize Spider SAS Physi...

Страница 19: ...person who followed the required training based on the local regulation Training completion and effectiveness are under his her medical supervisor s responsibility 6 USER PROFILE SPIDER SAS PHYSIO HUB...

Страница 20: ...r Lithium battery Event Button On Off button Physio Hub connector Loudspeaker Open hood switch ECG cable connector PHYSIO HUB PARTS Connector for belt s Sub 9D connector for pulse oxymeter sensor Luer...

Страница 21: ...RS software is provided in the Spider SAS packaging and must be installed before using the device HOW TO OPEN SPIDER SAS The figure on the left shows how to open Spider SAS in order to access the batt...

Страница 22: ...ou hear a click To extract the ECG connector use the upper lip Gently press with the nail of your right index toward the top to remove the cable NOTE When not in use Spider SAS can be stored without d...

Страница 23: ...d for more than 1 month it is recommended to remove the AAA battery to avoid electrolyte leak See 4 1 Consequently if the device is stored for a very long period of time the internal battery will run...

Страница 24: ...l cannula 1 transportation Blue pouch in which the patient will carry accessories RECOMMENDED POSITION Recommended steps in order to obtain accurate and reliable results of the procedure Connect the c...

Страница 25: ...Up RS software see section 10 3 1 To ensure a high quality ECG recording the patient s skin must be prepared meticulously The same rule applies for electrode placement and cable connection Rub the ski...

Страница 26: ...nal respiratory effort The recommended placement of the abdominal belt is just above the belly button Connect the abdominal sensor to the longest part of the Y adaptor NOTE The abdominal belt should b...

Страница 27: ...e finger as shown below Gently squeeze the sides to open the sensor Slide onto the finger to the end of the sensor with cable on top of hand Place fingertip at but not pushed through the end of sensor...

Страница 28: ...POSITIONING OF SPIDER SAS ACCESSORIES Picture provided as an indication only The position of each part can vary from case to case 8 8 8 PATIENT USE 28 SPIDER SAS PHYSIO HUB HOOKUP RS U908F...

Страница 29: ...rs and software by using Device Manager command from Windows Operating System Belkin interface uses the standard Bluetooth protocol with specific Belkin drivers After installation Spider SAS must be p...

Страница 30: ...successfully To proceed use the CD Rom provided with the Belkin BTLE dongle Follow the instructions displayed on the screens step by step Once the installation has finished open Bluetooth manager by...

Страница 31: ...ons of the manufacturer of BTLE interface see left To check the BTLE adapter was correctly installed on the desktop right click on the icon My computer then select consecutively Properties Hardware De...

Страница 32: ...h all detectable devices close to the PC max 3 or 4 meters Spider SAS is recognized by the BTLE interface as MicroPort Sensor BLE 05 BLUEGIGA BLUETOOTH INTERFACE NOTE BLED112 pairing operation must be...

Страница 33: ...0 resolution of the screen and BTLE interface from Belkin Insert HookUp RS or Synescope 3 30 installation CD ROM wait for Autorun Autorun or run HUESV2 EXE to start it manually Select the option Insta...

Страница 34: ...device Orange and Green Orange for initialization mode Green for functioning mode Once Spider SAS is On programming mode status LED flashes orange every second 9 HOW TO PAIR SPIDER SAS WINDOWS 34 SPI...

Страница 35: ...f PhysioHub is connected to the Spider SAS when launching HookUp RS Holter mode 24 or 48 hours continuous ECG only if PhysioHub is not connected to the Spider SAS when launching the HookUp RS GENERAL...

Страница 36: ...o allow SAS recording at night If not SpiderSAS will record in Holter mode ECG only Accelerometer Orientation accelerometer is embedded in Spider SAS to indicate the spatial position of the body On th...

Страница 37: ...n saturation 2nd channel for plethysmography curve Cursor to adjust the amplitude of the ECG signal displayed in graphic areas and The cursor does not modify the gain of the recorded signal Colored ba...

Страница 38: ...d NOTE If the button is not pressed the data will be deleted when the button Start Start will be pressed Patient to record fields can now be filled up If the patient is connected to Spider SAS ECG sig...

Страница 39: ...sition is shown independently for every channel ECG 1 and ECG 2 The bar graph color is fully blue when the quality of impedance is good enough NOTE If the amplitude of the signal is not sufficient do...

Страница 40: ...the right side If there is no PhysioHub connected the HookUp RS displays No cable the recording will be launched in Holter mode ECG only Accelerometer Orientation indicates in real time the position i...

Страница 41: ...nd with the current value displayed on the left 96 The blue line indicates a threshold value selected in settings see 10 1 The black curve displays the level of peripheral oxygen saturation calculated...

Страница 42: ...See 7 1 11 Close the cover then turn the lock with a screwdriver 12 Insert Spider SAS into holster RG017 then secure it by closing the holster 13 Adjust the thoracic and abdominal belt s as described...

Страница 43: ...shirt 7 Connect the ECG patient cable to the recorder See 7 1 8 Close Spider SAS See 7 6 9 Insert Spider SAS into holster RG017 then secure it by closing the holster 10 Check all is fine with HookUp...

Страница 44: ...no computer available at the location where Spider SAS would be used However certain conditions described below must be fulfilled to activate Spider SAS LIMITATIONS OF USE No battery check No signal...

Страница 45: ...ith a screwdriver 13 Insert Spider SAS into holster RG017 then secure it by closing the holster 14 Adjust the thoracic and abdominal belt s as described in 8 4 and 8 5 15 Connect the thoracic and abdo...

Страница 46: ...sition of the holster around the neck see 8 2 12 Click on ev button front face of Spider SAS recorder to begin the recording see 7 1 NOTE To ensure the recording has started properly Spider SAS must b...

Страница 47: ...able if Spider SAS is still flashing green and Bluetooth interface on the computer is activated Run HookUp RS then check click on Connection Connection button When Spider SAS is connected check the Pa...

Страница 48: ...rap Single patient 25 LA800 Spider SAS 1 RC013 Long cable 3 leads 2 Channels 1 RC032 Short cable 3 leads 2 Channels 1 THLA0001B Pack of 30 anallergic ECG electrodes 30 LB001 SD card for Spider SAS wit...

Страница 49: ...ICAL CHARACTERISTICS Temperature range of atmospheric pressure humidity Storage and transportation See 4 1 Storage and Transportation Operation See 4 2 Conditions for use Characteristics Spider SAS Ph...

Страница 50: ...N Radio Equipment Transmitter Bands Maximal Power Receiver Frequency Bands Spider SAS Bluetooth Low Energy 2400 2483 5 MHz 10 mW 0 dB 2400 2483 5 MHz 14 5 14 TECHNICAL SPECIFICATIONS 50 SPIDER SAS PHY...

Страница 51: ...including the NEUTRAL ELECTRODE should not be put in contact with conductive parts or earthed parts Teach and repeat to the patient that he she should not re apply electrodes on irritated or injured a...

Страница 52: ...second night recording the cannula must be reconnected as described above HOW TO CONNECT FINGER SENSOR TO HUB Put the sensor on the finger that the patient prefers according to comfort and recommenda...

Страница 53: ...PATIENT BOOKLET Before recording steps and after recording steps and 15 5 15 APPENDIX 1 PATIENT RECOMMENDATIONS SPIDER SAS PHYSIO HUB HOOKUP RS U908F 53...

Страница 54: ...pter must therefore be strictly observed The medical device must not be used near or on another device If this cannot be avoided it must be checked for proper operation under the conditions of use bef...

Страница 55: ...EC 61000 3 3 Non applicable GUIDANCE AND MANUFACTURER S DECLARATION MAGNETIC AND ELECTROMAGNETIC IMMUNITY Spider SAS is intended for use in the electromagnetic environment specified below The customer...

Страница 56: ...se during power cuts it is recommended that the medical device be powered by a separate power source UPS etc NOTE UT is the a c mains voltage prior to application of the test level GUIDANCE AND MANUFA...

Страница 57: ...te survey 1 should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol NOTE These guidelines may not apply in...

Страница 58: ...se in an electromagnetic environment in which radiated RF disturbances are controlled Portable RF communication devices including peripherals such as antenna cables and external antennae should not be...

Страница 59: ......

Страница 60: ...ino S N 13040 Saluggia VC Italy Tel 39 0161 487095 www crm microport com MANUFACTURED IN FRANCE FOR US Phone 877 663 7674 FOR US ONLY CAUTION FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORD...

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