User manual Spider SAS (U908F) Document ref. Rev. MISC11035 C REVISION HISTORY Rev. Revised Section/Paragraph A Creation. Enclosed: User manual Spider SAS U908E For approval of the document before launching the AM process. B Enclosed: User manual Spider SAS U908F Update for US/CAN submission. 4.5. WARRANTY Updated from: All reusable sensors are guaranteed for 1 (one) year from the date of delivery. Belts and bags are eligible for a 3-month warranty.
User manual Spider SAS (U908F) Document ref. Rev. MISC11035 C This equipment has very low levels of RF energy that is deemed to comply without testing of specific absorption rate (SAR). CANADA This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
Spider SAS Apnea & Rhythm recorder USER MANUAL
TABLE OF CONTENTS 1. INTRODUCTION ........................................................................................................ 6 1.1. Typography convention .............................................................................................. 6 1.2. Description of symbols on the case............................................................................ 6 2. DEFINITIONS............................................................................................................
8. PATIENT USE.......................................................................................................... 24 8.1. Description ............................................................................................................... 24 8.2. Recommended position............................................................................................ 24 8.3. Electrode placement................................................................................................. 25 8.
15. APPENDIX 1: PATIENT RECOMMENDATIONS .................................................... 51 15.1. Pediatric use............................................................................................................. 51 15.2. Reminders ................................................................................................................ 51 15.3. Nasal cannula........................................................................................................... 51 15.4.
1. INTRODUCTION 1. INTRODUCTION 1.1. TYPOGRAPHY CONVENTION This manual often refers to screenshots, originated from the programming software HookUp RS used in its initial English version. The references to these screens are displayed in English and in the local language; they are identified by the following symbols: [ ]: English (original text in the screenshots - bold font). { }: Local language of the labels displayed in the screenshots. 1.2.
1. INTRODUCTION Medical equipment with respect to electric shock, fire, and mechanical hazards, 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 Commission.
2. DEFINITIONS 2. DEFINITIONS 2.1. ACRONYMS AND DEFINITIONS BT Bluetooth(1): Generic term for naming all types of wireless interfaces according to Bluetooth consortium specifications (regardless of the Bluetooth protocol version). BTLE or BT 4.0 Bluetooth®(1) Low Energy, also called Bluetooth 4.0., enables HookUp RS to communicate with Spider SAS. ev Event button located on the front of Spider SAS.
2. DEFINITIONS SVT Periods of supraventricular tachycardia detected during a recording. Tachycardia threshold’s value defined in the rhythm protocol. Tachycardia only detected if the mean rate is higher than the threshold value for at least 5 seconds. VPB All ventricular premature beats detected during a recording. VPB/1: one isolated ventricular premature beat. VPB/2: pair of consecutive ventricular premature beats. VPB/3: 3 or more consecutive ventricular premature beats.
3. SPIDER SAS OVERVIEW 3. SPIDER SAS OVERVIEW 3.1. PRESENTATION AND INTENDED USE Spider SAS is an ECG and Apnea monitor able to record relevant physiologic signals for evaluating Sleep Apnea Syndrome.
3. SPIDER SAS OVERVIEW 3.2. PERFORMANCES Main performance of Spider SAS and PhysioHub is to record data from various sensors (see § 3.1). 3.3. CONTRAINDICATIONS AND SIDE EFFECTS There are no contraindications or side effects associated to the use of Spider SAS and its accessories.
4. PRECAUTIONS FOR USE AND MAINTENANCE 4. PRECAUTIONS FOR USE AND MAINTENANCE 4.1. STORAGE AND TRANSPORTATION The Spider SAS is packaged as outlined in the packaging chapter at time of delivery.
4. PRECAUTIONS FOR USE AND MAINTENANCE CAUTION: Spider SAS does not start if a MicroPort SD card is not inserted. NOTE: µSD cards designed for MicroPort devices cannot be used with other devices. µSD cards can be used up to 300 000 times. These cards resist electrostatic discharges of ± 4kV maximum in the event of direct contact with the electrodes and ±8 kV apart from the zone of the electrodes (flat contact). The µSD cards can resist a shock of 1 000 G maximum.
4. PRECAUTIONS FOR USE AND MAINTENANCE Damaged, bent or dust-polluted µSD cards and sensors are not covered by warranty. 4.6. END OF SERVICE When Spider SAS or Physio Hub reaches end of service, it should be returned to MicroPort for appropriate recycling. The batteries should be recycled according to the local regulation and/or procedures. ECG cables, accessories and reusable holster bag should also be disposed of appropriately. 4.7.
4. PRECAUTIONS FOR USE AND MAINTENANCE 2. this device must accept any interference, including interference that may cause undesired operation of the device. Under Industry Canada regulations, this radio transmitter may only operate using an antenna of a type and maximum (or lesser) gain approved for the transmitter by Industry Canada. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotropically radiated power (e.i.r.p.
5. CLEANING 5. CLEANING CAUTION: A recently cleaned device must be dried carefully to avoid any oxidation of the electrical contacts before long term storage. 5.1. SPIDER SAS AND PHYSIO HUB The external case and the patient cable (including snap-on clips) must be cleaned with professional liquid soap and disinfectants. Do not use detergents, alcohol or acetone. The electrical parts and the connectors should be cleaned daily in order to avoid dysfunctions.
5. CLEANING 5.3. PIEZO EFFORT SENSOR FOR RESPIRATION This sensor is manufactured by SleepSense. The Piezo Film Effort Sensor Kit requires a L or XL band (see § 13 Software, Hardware & Accessories). The bands can be wiped with a mild detergent or washed in a gentle machine cycle. Wipe the cable with a non-corrosive (to plastic) cleanser to clean before use. Make sure the bands and cable are thoroughly dry before reusing them.* *(http://www.sleepsense.com/resources.html) 5.4.
5. CLEANING To be efficient, the duration of contact with each element of Spider SAS must be strictly respected according to the instructions provided by the product manufacturer. CAUTION: If the protocol used requires disinfection of the electrical contacts (battery contacts of the recorder and the contacts of µSD card), it is essential to carefully dry these contacts before reusing the Spider SAS and the µSD card.
6. USER PROFILE 6. USER PROFILE Any person who followed the required training based on the local regulation. Training completion and effectiveness are under his/her medical supervisor’s responsibility.
7. GENERAL DESCRIPTION 7. GENERAL DESCRIPTION 7.1. 7.2.
7. GENERAL DESCRIPTION 7.3. BLUETOOTH DONGLE Before commencing the recording, Spider SAS must be prepared with HookUp RS software which requires a BTLE interface. Bluetooth 4.0 Low Energy USB (BTLE) BlueGiga™ BLED112 is provided with Spider SAS. NOTE: Hookup requires a BTLE interface for setting up Spider SAS. The embedded interface can be used if the laptop is equipped with a Bluetooth Low Energy interface which integrates a Broadcom, Intel or Texas Instruments chipset.
7. GENERAL DESCRIPTION 7.6. HOW TO CLOSE SPIDER SAS To close Spider SAS clip the right side of the back part into the orange plastic part then apply a light pressure (black arrows) on the left part with your thumb until the back cover is locked (with a click) onto the orange plastic part. Then lock the back side of the Spider SAS (using a screwdriver or a coin). 7.7. ECG CABLE INSERTION AND EXTRACTION The insertion (① then ➋) of the patient cable should be done as indicated in the picture.
7. GENERAL DESCRIPTION A new Lithium battery ensures 1 day 2 channel ECG recording including 2 nights of 8 hour nocturnal respiratory polygraph. NOTE: Place a new battery for each new recording in order to ensure the duration announced above. 7.8.2. Internal memory battery Spider SAS contains an internal battery recharged by the device’s main AAA battery. This memory battery ensures the maintenance of the system’s date and time and other parameters in the absence of the main battery for about 30 days.
8. PATIENT USE 8. PATIENT USE 8.1. DESCRIPTION NOTE: Advise the patient to wear a T-shirt before setting up the recording. This way, Spider SAS, Physio Hub and belt(s) are not directly in contact with the skin. The long ECG cable (RC013) should be used instead of the short one (RC032). CAUTION: Connect the patient to the SpiderSAS only when the back of the SpiderSAS is in place.
8. PATIENT USE NOTE: Spider SAS is worn by the patient for at least one night. Both reusable and disposable neck holsters have been designed to guarantee maximum comfort and hygiene for the patient and to protect the recorder from sweat. Spider SAS is firmly maintained in the holster locked by a simple metal clip. Place the holster around the neck following the picture (see §8.8). Adjust the cord length so that Spider SAS is located at the top of the patient’s sternum.
8. PATIENT USE WARNING: Conductive parts of electrodes (including the neutral electrode), should not be put in contact with conductive parts or earthed parts. 8.4. CHEST BELT PLACEMENT Apply the thoracic belt on the patient’s chest to measure the thoracic respiratory effort. The recommended placement of the thoracic belt is between the axillae (underarms) and above the lower part of the sternum (xiphoid).
8. PATIENT USE 8000S Sensor Digit Thickness 8.7.2. Type Size (mm) Size (in) S 7.5 - 12.5 0.3 – 0.5 M 10.0 – 19.0 0.4 – 0.75 L 12.5 – 25.5 0.5 – 1.0 How to place the sensor The sensor can be positioned on index, middle or ring finger. The choice of finger does not affect accuracy of measurement; however thickness of the chosen finger must be related to the size of the sensor. For comfort reasons, the cable is placed on the top of the finger as shown below (➌).
8. PATIENT USE 8.8. POSITIONING OF SPIDER SAS & ACCESSORIES Picture provided as an indication only. The position of each part can vary from case to case.
9. HOW TO PAIR SPIDER SAS (WINDOWS) 9. HOW TO PAIR SPIDER SAS (WINDOWS) NOTE: Depending on provider, abbreviation of Bluetooth can be either BL, BLE, BTLE or BT 4.0 9.1. DESCRIPTION NOTE: The pairing operation or Bluetooth COM port emulation installation must be performed before using HookUp RS. The following pictures are issued from Windows 8.1 after successful installation of drivers and software by using Device Manager command from Windows Operating System.
9. HOW TO PAIR SPIDER SAS (WINDOWS) 9.2. BELKIN BLUETOOTH INTERFACE NOTE: The pairing operation is possible only after a successful installation of the BTLE interface Belkin with the CD Rom joined with the dongle. This operation must be done before using HookUp RS). Spider SAS must be switched on in order for pairing to be achieved successfully. To proceed, use the CD Rom provided with the Belkin BTLE dongle. Follow the instructions displayed on the screens step by step.
9. HOW TO PAIR SPIDER SAS (WINDOWS) Spider SAS is recognized by the BTLE interface as {MicroPort Sensor BLE 05}. Click on the icon (framed in purple above) to pair Spider SAS with the computer. If a password is required type "0" or "000000". Spider SAS paired successfully with the computer. Pairing can be checked with Device Manager (see below). The Bluetooth key must be installed according to the instructions of the manufacturer of BTLE interface (see left).
9. HOW TO PAIR SPIDER SAS (WINDOWS) To proceed, open Bluetooth manager by clicking on the icon displayed on Windows desktop or Windows taskbar then select "Add a Bluetooth Device". Once BTLE is activated, the interface will search 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}. 9.4.
9. HOW TO PAIR SPIDER SAS (WINDOWS) The Bluetooth key must be installed according to the instructions of the manufacturer of the 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} ⇨{Device manager ❶} the BTLE adapter should be displayed ➋. 9.5. INSTALLATION OF HOOKUP RS SOFTWARE The software can be installed on Windows XP SP2 (minimum OS configuration), Windows 7, 8, 8.
9. HOW TO PAIR SPIDER SAS (WINDOWS) NOTE: Status LED (2) is a two-colored 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.
10. STARTING A RECORDING WITH HOOKUP RS 10. STARTING A RECORDING WITH HOOKUP RS HookUp RS is the programming software to set-up, initialize and start Spider SAS. It allows to quickly review the parameters of the recording and the signal quality before starting the recording.
10. STARTING A RECORDING WITH HOOKUP RS ➁ COM port number (BlueGiga dongle) Automatically added to the list of COM ports but not selected by default.
10. STARTING A RECORDING WITH HOOKUP RS ➐ [Shutdown] and [Start] buttons respectively for stopping the recording and beginning the recording NOTE: To stop the recording, Spider SAS must be paired with and connected to the PC.
10. STARTING A RECORDING WITH HOOKUP RS Click on [Connection] / {Connection} button, HookUp RS initiates the BTLE communication with Spider SAS. When the communication is successful, serial numbers of recorders detected by HookUp RS are listed in a popup window in order to select the Spider SAS. Select serial number (S/N) to connect to the recorder. [Connection] / {Connection} button is renamed [Disconnect] / {Disconnect}.
10. STARTING A RECORDING WITH HOOKUP RS 10.3.1. ECG signal Quality Make sure that the patient’s skin has been properly cleaned and dried before electrodes are positioned. The upper channel displays lead A (red and white electrode), the lower channel displays lead B (brown and white electrode). If the QRS amplitude on the ECG is lower than 0.5 mV (➓), you should check the positioning and the quality of the electrodes.
10. STARTING A RECORDING WITH HOOKUP RS To evaluate sleep disordered breathing (SDB), it is necessary to activate all sensors during the nocturnal period. By default that period is activated between 10:00 pm and 06:00 am. According to patient's habits, it is possible to select another period from the drop down list shown on the left. This time will not be taken into account if the Spider SAS is used in Holter recording mode.
10. STARTING A RECORDING WITH HOOKUP RS ― Abdominal belt ➍ Refer to § 8.4 and § 8.5 for the belt(s) and §8.6 for detailed information on placement of cannula. 10.5. OXYGEN SATURATION AND PLETHYSMOGRAPHY SCREEN To display the screen below click on [SpO2 - Plethysmo] tab ➊. ➋ Oxygen saturation trend with the current value displayed on the left (96%). The blue line indicates a threshold value selected in settings (see § 10.1).
10. STARTING A RECORDING WITH HOOKUP RS ➌ Plethysmography signal is provided for checking the quality of the current oxygen saturation signal captured by the sensor. ➍ Click on the [Start] / {Start} button to begin recording. When done, Spider SAS beeps. Once the status led is flashing green, Spider SAS is recording all signals and Hookup RS can be closed. Then status led flashes green every 2 seconds. Recording is ongoing.
10. STARTING A RECORDING WITH HOOKUP RS 2. Insert µSD card (See § 7.1) 3. Insert a new battery in the recorder (See § 7.1) 4. Connect the clips of the ECG cable to electrodes 5. Apply the electrodes to the patient’s chest (See § 8.3) 6. Ask the patient to put on his/her t-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 RS 11.
11. STARTING RECORDING: ANONYMOUS MODE 11. STARTING RECORDING: ANONYMOUS MODE 11.1. GENERAL DESCRIPTION The procedure described in this chapter is named [Anonymous] / {Anonymous}. This naming comes from the ID automatically given by Spider SAS when that mode is used.
11. STARTING RECORDING: ANONYMOUS MODE NOTE: If Spider SAS is started several times without the assistance of HookUp RS software, date and time are not the current one. To re-synchronize, launch a procedure with HookUp RS. (See §10.3.2) When the update is done the tick-box is "ON". You can then change the Time and Date with the function [Adjust Time-Date] / {Adjust Time-Date}. CAUTION: It is strongly recommended not to use Windows formatting tools to erase the SD card. 11.5.
11. STARTING RECORDING: ANONYMOUS MODE 10. Insert Spider SAS into holster (RG017) then secure it by closing the holster 11. Adjust the position 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 be flashing green.
12. STOPPING A RECORDING 12. STOPPING A RECORDING CAUTION: Extraction of the card while ending the recording will immediately stop the recorder. Possibility of data loss. There is a high risk of major errors during the download of the recording. This chapter describes how to stop Spider SAS under the best conditions and to avoid the errors which could cause the loss of the recording.
13. SOFTWARE, HARDWARE AND ACCESSORIES 13. SOFTWARE, HARDWARE AND ACCESSORIES The following products, items and accessories are available for the Spider SAS recorder.
14. TECHNICAL SPECIFICATIONS 14. TECHNICAL SPECIFICATIONS 14.1. DESCRIPTION Spider SAS is a respiratory polygraph with O2 saturation, thoracic and abdominal respiration effort, nasal pressure, 2 ECG channels, the body position and an event button. This recorder is a class IIA medical device (according to directive EEC 93/42). 14.2. ELECTRICAL CHARACTERISTICS Frequency response: 0.05 - 80 Hz Common-mode rejection: 94 dB Input dynamic range: ± 16 mV ± 300 mV (low frequency) Power supply: 14.3.
14. TECHNICAL SPECIFICATIONS 14.5. RADIO EQUIPMENT EMISSION Radio Equipment Transmitter Bands / Maximal Power Receiver Frequency Bands Spider SAS [2400 ; 2483.5] MHz ; ≤ 10 mW (0 dB) [2400 ; 2483.
15. APPENDIX 1: PATIENT RECOMMENDATIONS 15. APPENDIX 1: PATIENT RECOMMENDATIONS 15.1. PEDIATRIC USE ― In the case of pediatrics, it is highly recommended that a nurse or physician demonstrates the use to the parents. ― Such a recording must be operated under parental supervision. CAUTION: If Spider SAS is not used, it must be placed in the blue transportation bag and out of reach of children and animals. If Spider SAS is worn, do not let children and animals touch equipment, nasal cannula or sensors. 15.
15. APPENDIX 1: PATIENT RECOMMENDATIONS 15.3.1. Connection to φ Hub 1. Insert the tube onto the connector 2. Gently screw clockwise a quarter turn to ensure a perfect connection with the pressure sensor. Adjust the other end of the nasal cannula as described in § 8.6 15.3.2. Removal from φ Hub After waking up, the patient shall remove the nasal cannula completely. In the case of a second night recording, the cannula must be reconnected as described above. 15.4.
15. APPENDIX 1: PATIENT RECOMMENDATIONS 15.5. PATIENT BOOKLET Before recording (steps ➊ and ➍), after recording (steps ➋, ➌, ➎ and ➏).
16. APPENDIX 2: ELECTROMAGNETIC COMPATIBILITY 16. APPENDIX 2: ELECTROMAGNETIC COMPATIBILITY 16.1. GUIDANCE AND MANUFACTURER'S DECLARATION All information below is based on the normative requirements to which the manufacturers of electro-medical devices are subject, in the sense of IEC60601-1-2.
16. APPENDIX 2: ELECTROMAGNETIC COMPATIBILITY 16.3. GUIDANCE AND MANUFACTURER'S DECLARATION: ELECTROMAGNETIC EMISSIONS The Spider SAS is intended for use in the electromagnetic environment specified below. The customer or the user of the Spider SAS should ensure that it is used in such an environment. 16.4.
16. APPENDIX 2: ELECTROMAGNETIC COMPATIBILITY Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Voltage dips 0% UT for 0.5 cycle (IEC 61000-4-11) At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° Non applicable Mains power quality should be that of a professional health care establishment. If operation of the system requires continued use during power cuts, it is recommended that the medical device be powered by a separate power source (UPS, etc.).
16. APPENDIX 2: ELECTROMAGNETIC COMPATIBILITY Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance Proximity fields emitted by RF wireless communication devices IEC61000-4-3 (provisional method) 9 V/m 9 V/m 710 MHz, 745 MHz, 780 MHz, 710 MHz, 745 MHz, 780 MHz, Professional health care establishment.
16. APPENDIX 2: ELECTROMAGNETIC COMPATIBILITY 16.6. SPIDER SAS AND MOBILES (RECOMMENDATIONS) 16.6.1. Guidance and manufacturer's declaration: electromagnetic immunity Recommended separation distances between portable and mobile RF communications equipment and the Spider SAS. The Spider SAS is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
MANUFACTURED IN FRANCE FOR: MicroPort CRM S.r.l. Via Crescentino S.N. 13040 Saluggia (VC) Italy Tel: +39 0161 487095 US Phone: 877.663.7674 www.crm.microport.
