Users Manual
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User’s manual
SPIDERFLASH-t
Long duration event recorder with enhanced recording capability & extended memory capacity
HOOKUP
Programming software to set-up & initialize Spiderflash-t
TABLE OF CONTENTS 1.Introduction ···································································································································· 3 1.1 1.2
Use in the United States ...3 Typography convention ...3
2.Definitions ······································································································································ 4 2.1 2.2
Acronyms and definitions ...4 Abbreviations (rhythm) ...5
3.Spiderflash-t overview ····················································································································· 6 3.1 3.2 3.3
Presentation & Operation ...6 Recording duration ...7 Data analysis ...7
4.Precautions of use and warnings ······································································································ 8 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9
Transportation ...8 Conditions of storage and carriage ...8 Conditions of use ...9 Electromagnetic environment ...9 Cleaning ...9 Disinfection ...10 Care and repair of the device ...11 Warranty ...11 End of life ...11
5.User Profile ·································································································································· 12 6.General description ······················································································································· 13 6.1 6.2 6.3 6.4 6.5 6.6
Elements of Spiderflash-t ...13 Description of symbols on the case ...14 How to open Spiderflash-t ...15 Cable insertion and extraction ...16 Batteries and rechargeable batteries...16 Internal memory battery ...17
7.Patient use ··································································································································· 18 7.1 7.2 7.3 7.4 7.5
Neck position ...18 Belt position ...19 Electrode placement ...19 3 leads patient cable ...20 2 leads patient cable ...21
8.HookUp - Programming software ····································································································· 22 8.1 8.2 8.3
Definition ...22 Programming modes ...22 Recording Protocols ...23
9.HookUp programming software installation ······················································································ 25 9.1 9.2 9.3
Serial port infrared cable ...25 USB port - Infrared cable ...26 Installation of HOOKUP software on PC ...27
10.HookUp IR progamming mode ······································································································· 28 10.1 10.2 10.3 10.4 10.5
How to set-up the IR connection between computer & SPF-t ...28 IR communication on-screens illustrations ...29 Starting the HookUp IR mode ...30 ECG signal Quality ...32 Demographic data and Date/Time update ...33
10.6 10.7 10.8
Configuration of the Auto Triggered mode (A.T.) ... 34 Configuration of the Patient Activated mode (P.A.) ... 36 Starting the monitoring ... 37
11.HookUp CS progamming mode ······································································································ 41 11.1 11.2 11.3 11.4
Description ... 41 Particular warnings ... 41 Recording preparation ... 42 Other functions ... 43
12.Anonymous Mode ························································································································ 45 12.1 12.2 12.3 12.4
Description ... 45 Limitations of use ... 45 Conditions for Starting the recorder ... 45 Starting the recorder ... 46
13.Stopping the recorder··················································································································· 47 14.Transtelephonic Transmission······································································································· 48 15.Spiderflash-t beeps & flashes ········································································································ 49 15.1 15.2
Programming: ... 49 In Use : ... 50
16.Software, Hardware & Accessories ································································································· 51 16.1 16.2
Packaging ... 51 Products codes ... 51
17.Technical specifications ··············································································································· 52 17.1 17.2 17.3 17.4 17.5 17.6
Description ... 52 Number of derivations ... 52 Electric characteristics ... 52 Mechanical characteristics ... 52 Characteristics of acquisition ... 52 Protection index ... 52
18.Appendix 1: Patient recommendations···························································································· 53 19.Appendix 2: Infrared communication ······························································································ 54 20.Appendix 3: Patient Diary ·············································································································· 55 21.Appendix 4: Electromagnetic compatibility······················································································ 56 21.1 21.2
Guidance and manufacturer's declaration ... 56 Spiderflash-t and Mobile (recommendations) ... 59
1. INTRODUCTION
1.
INTRODUCTION 1.1
USE IN THE UNITED STATES USA Only
[CAUTION: Federal law restricts the sale of this device by or on the order of
1.2
a physician.]
{CAUTION: Federal law restricts the sale of this device by or on the order of a physician.}
TYPOGRAPHY CONVENTION This manual often refers to screenshots, originated from the programming software named HookUp used in its initial English version. The references to these screens being in English, they are mentioned in this document and framed by the following symbols: • •
[ ] : English (original text of the elements shown in the screens) { }: Local language of the elements shown in the screens.
This icon is used to call your attention to a particularly important point.
This icon alerts you to a hazard that may result in equipment damage or personal injury. Carefully read the instructions provided with this icon.
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2. DEFINITIONS
2.
DEFINITIONS 2.1
ACRONYMS AND DEFINITIONS
Eventscope
Self-starting programming mode of Spiderflash-t. Default protocol automatically used by SPF-t if no settings are inputted (See § 12, page 45) [Automatically Recorded] {Automatically Recorded} Routine ECG strips recorded at a predetermined time. 2x30 seconds every day at 01:30 and 13:30 by default. Time & duration can be changed with HookUp. [Auto Triggered] {Auto Triggered} ECG event(s) automatically identified by Spiderflash-t which will simultaneously trigger a recording. Duration in number of days during which a patient will be monitored (See § 3.2, page 7) Analysis software of Spiderflash-t
HookUp
Programming software of Spiderflash-t
HookUp CS
Programming mode of the HookUp software using the Card Start function directly on the SD Card to program Spiderflash-t (See § 11, page 41) Programming mode of the HookUp software using infrared transmission to program Spiderflash-t (See § 10, page 28) Heart rate trend. Consists of a mean heart rate curve calculated every minute (light line) and maximum and minimum values over the same period (dark line). Permanent surveillance loop constantly checking the heart rhythm. SPF-t will record an event at occurrence, 15 minutes of ECG strips before, and a maximum of 7.5 minutes of ECG strips after with one channel. Data is then memorized onto an SD card as many times as necessary with no limitation. [Patient Activated] {Patient Activated} ECG events(s) identified by the patient by actively pushing on the green button of the Spiderflash-t. Spiderflash-t
Anonymous A.R.
A.T. Duration
HookUp IR HR (bpm) Loop memory
P.A. SPF-t
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2. DEFINITIONS
2.2
ABBREVIATIONS (RHYTHM) Brady
Periods of bradycardia 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 10 seconds.
MB
Missed Beat period detected during a recording. Equals to a rate reduction of 75% (i.e. 175% of the previous RR) compared to the mean rate. Missed beats are not detected during segments of unstable rhythm.
Pause
Pauses detected during a recording. The minimum duration of a pause is defined in the rhythm protocol. Pauses between two artifacts are not detected.
RR inst
RR interval instability, periods of irregular supraventricular cardiac rhythm detected during a recording. These maybe periods of atrial fibrillation, atrial flutter or sinus arrhythmia.
SVPB
All supraventricular premature beats detected during a recording. SVPB/1: one isolated supraventricular premature beat. SVPB/2: pair of consecutive supraventricular premature beats. SVPB/3: 3 or more consecutive supraventricular premature beats. All isolated, couplets or runs are indicated in red. Number of events detected per minute related to the trends bar height. SVPB count during runs voluntarily stopped at 22 beats, necessary to minimize risk of misdetection of events during false positive SVPB runs. The “MaxHR” value indicated on the label of the run event is calculated on as many RR intervals as set for the calculation of Min/Max HR. If not enough RR values are available, 2 values are used.
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. All isolated, couplets or runs are indicated in red. Number of events detected per minute related to the trends bar height. VPB count during runs voluntarily stopped at 22 beats, necessary to minimize risk of misdetection of events during false positive VPB runs. The “Max HR” value indicated on the label of the run event is calculated on as many RR intervals 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 can be defined in the rhythm protocol. Tachycardias are only detected if the mean rate is higher than the threshold value for at least 5 seconds.
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3. SPIDERFLASH-T OVERVIEW
3.
SPIDERFLASH-T OVERVIEW 3.1
PRESENTATION & OPERATION Spiderflash-t is a long duration event recorder with enhanced recording capability & extended memory capacity. Spiderflash-t identifies & records all relevant ECG events out of a maximum of 22.5 minutes duration thanks to its unique combination of a permanent surveillance loop coupled with an extended memory capacity with one channel. The maximum duration is 11.25 minutes with 2 channels. Precisely, with one channel Spiderflash-t features a permanent 15 minute surveillance loop constantly checking the heart rhythm. SPF-t will record an event at occurrence, 15 minutes of ECG strips before, and a maximum of 7.5 minutes of ECG strips after. This valuable information is then memorized onto the SD card without any limitation, ready to be easily analyzed by Eventscope to provide a long term full & accurate patient status. Spiderflash-t is small, light and user friendly. Spiderflash-t: • Is indicated for the long term monitoring of patients presenting cardiac rhythm disorders, or suspected with, for up to 5 weeks. • Features a permanent surveillance loop that allows recording of an event and its onset over 15 / 7.5 minutes before its occurrence with respectively 1 or 2 channels. • Features a maximum 7.5 / 3.75 minutes recording post event with respectively 1 or 2 channels. • Records ECG events / strips on an SD card with unlimited memory capacity. • Records therefore a maximum duration per event of 22.5 minutes, 15 minutes before & 7.5 minutes after an event, with 1 channel. • Records therefore a maximum duration per event of 11.25 minutes, 7.5 minutes before & 3.75 minutes after an event, with 2 channels. • Can record a continuous 24 hour Holter ECG. • Can be activated manually by the patient (P.A. mode, Patient Activated). • Is automatically activated by an embedded algorithm which identifies the cardiac arrhythmias (A.T. mode, Auto Triggered). • Can record an ECG strip at a predefined time (A.R. mode, Automatically Rec.) • Records all RR intervals independently from the ECG, ensuring an efficient & swift physician status check when looking for atrial fibrillation. • Features a specific detection algorithm for atrial fibrillation. The embedded algorithms in Spiderflash-t allow detection of episodes of palpitation, syncope, atrial fibrillation and atrial flutter in addition to of all others arrhythmias such as bradycardia and tachycardia among symptomatic and asymptomatic patients. Spiderflash-t embedded software includes a dedicated and specific algorithm to detect Atrial Fibrillation. This AF algorithm is independent from the main arrhythmia detection algorithm also embedded into Spiderflash-t. Spiderflash-t can monitor a patient up to 40 days with 2 ECG channels. Spiderflash-t can be used for children less than 10 kg.
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3. SPIDERFLASH-T OVERVIEW The ECG data are stored on the SD card if one of the following conditions occurs: • Event button pressed by the patient when experiencing a symptom (P.A. mode, Patient Activated). • Automatic detection of arrhythmic events (A.T. mode, Auto Triggered). • Automatic recording of an ECG strip at a predefined time (A.R. mode, Automatically Recorded), according to a protocol defined with the HookUp software (by default 2 recordings each day at 01h30 and 13h30). • If the continuous 24 hour Holter ECG mode is activated. • Combination of the above mentioned events nd
st
2 P.A.
1 P.A. tB
tA
ECG 1 Extra time tA scenario example of 2 patient activations = 1 P.A. event created
Figure 1
3.2
RECORDING DURATION Total recording duration is based on the device battery duration. This duration varies from 14 days up to 40 days according to the following parameters: • Type & quality of the battery (Alkaline or Lithium) • Number of leads (2 or 3 leads working respectively on 1 or 2 channels) • Selected protocol or recording mode • Duration, intensity & number of events recorded per day • Environment & activity of the patient • Quality of the patient hookup (electrode quality and application) In greater detail, the battery duration depends on the following factors: • Recording modes: P.A., A.T., A.R. o
o
Battery minimum duration of 14 days with P.A., A.T. & A.R. modes all activated with 3 leads & 2 channels. Battery average duration of 21 days with P.A., A.T. & A.R. modes all activated with 3 leads & 2 channels. Battery maximum duration of 40 days with P.A. mode activated only
o
More pre-selected events to detect, greater energy needs.
o
Depend on the values of [Time Before] {Before} and [Time After] {After}. More events to detect, longer events to detect, greater energy needs.
o
•
Daily numbers of pre-set events in A.R. & A.T. modes:
•
Event durations, frequencies, intensities & occurrences:
• • •
3.3
o
Fast heart rate & number of detected artifacts. Holter 24 hour continuous recording mode activation uses 5 battery days. Lithium batteries are reported to last longer and should be the primary choice.
DATA ANALYSIS The Eventscope software is used to download, visualize, analyze, modify and print the data recorded with Spiderflash-t.
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4. PRECAUTIONS OF USE AND WARNINGS
4.
PRECAUTIONS OF USE AND WARNINGS 4.1
TRANSPORTATION The Spiderflash-t is packaged as outlined in the packaging chapter at time of delivery (§16.1, page 51).
4.2
CONDITIONS OF STORAGE AND CARRIAGE The following table shows the conditions of storage and transportation of Spiderflash-t: Storage and transportation
Temperature
Humidity
5% ～ 95% non condensing 8% ～ 95% SD card -20° ～ 65°C non condensing A protective bag is needed in case of severely wet environment. Recorder
-20° ～ 65°C
Pressure 500 hpa ～1060 hpa 500 hpa ～1060 hpa
Remove the battery before storing Spiderflash-t. CAUTION: In the event of long duration storage > 1 month, the battery must be removed from Spiderflash-t. According to the duration and conditions of storage and the battery quality type, there is a risk of electrolyte leak in the plastic case of Spiderflash-t. The consequence of such a leak can require returning device to SORIN GROUP After Sale Service department. Repair is excluded from the warranty and a fee will be charged.
CAUTION: If a leak or a powdery deposit is visible on the battery, in the compartment or on the electrical contacts, remove the battery and dispose it following the local environmental legislation and/or the envisaged procedures. If the leak is not important (no oxidation on the electrical contacts of the battery), it is possible to clean it with a slightly wet wipe, and then carefully dry the cleaned parts. In the event of traces of significant oxidation, it is strongly recommended to not use the device (risk of recording failure) and to return it to SORIN GROUP After Sale Service department. Repair is excluded from the warranty and a fee will be charged.
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4. PRECAUTIONS OF USE AND WARNINGS
4.3
CONDITIONS OF USE CAUTION: If a patient carrying a Spiderflash-t recorder needs to be defibrillated, it is mandatory that the recorder’s electrodes are removed before the defibrillator is used. The table below illustrates conditions of use of Spiderflash-t:
Use
Temperature
Humidity
Pressure
Recorder and SD card
0° ～ 45°C
10% ～ 95% no condensing
700 hpa ～ 1060 hpa
The correct operation of Spiderflash-t is only guaranteed when used with SD cards provided by SORIN GROUP. In addition, SD cards designed for SORIN GROUP devices cannot be used with other devices. The SD cards are useable up to 300.000 times. These cards resist electrostatic discharges of ± 4kV maximum in the event of direct contact with the electrodes and of ± 8 Kv apart from the zone of the electrodes (contact flat). The SD cards can resist a shock of 1 000 G maximum. Spiderflash-t is not protected from the effects of external defibrillation shocks nor against high frequency signals or strong electromagnetic disturbances.
CAUTION: Spiderflash-t shall not be used in environments with flammable anesthetic mixtures with oxygen or nitrous oxide.
4.4
ELECTROMAGNETIC ENVIRONMENT The use of portable and mobile RF communication equipment (ex. cellular phones) can affect the event recorder since the recorded ECG signal may be disturbed due to electromagnetic interference and the device may trigger the recording of ECG events due to misinterpretation of noisy ECG signal. The device shall not be used in presence of ionizing radiations (x-rays, gamma rays…) that could damage the internal memory and the SD card. Concerning the electromagnetic emissions and the level of the immunity of the recorder, see Appendix 4: Electromagnetic compatibility, page 56.
4.5
CLEANING The external case and the patient cable (including snap-in clips) must be cleaned with professional liquid soap and disinfectants. Detergents, alcohol or acetone must not be used. The electrical parts and the connectors should not be cleaned daily in order to avoid dysfunctions. After being cleaned, the materials must carefully be dried before storage. The Spiderflash-t device itself is not water / liquid proof.
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4. PRECAUTIONS OF USE AND WARNINGS
CAUTION: A recently cleaned device must carefully be dried to avoid any oxidation of the electrical contacts before long term storage.
CAUTION: It is strongly recommended not to immerse the snap-in clips of cables in a cleaning or disinfection solution. This method considerably shortens the life duration of cables and causes an important internal oxidation between the clip and the thread of the cable. The quality of ECG signal could be affected.
4.6
DISINFECTION Disinfection product manufacturers provide precise indications for their appropriate use with medical devices. Their compatibility with medical devices is clearly mentioned on their packaging and needs to be respected.
4.6.1
Methods Disinfection of the plastic case, cable and SD card are possible with a single-use wipe pre-filled with a disinfectant solution in compliance with the current standards: • bactericide: NF EN1040, EN 1276 • virucide: NFT72-180, NF EN 14476 • fungicide: NF EN 1275 • levuricide: NF EN 1650 The solution used must be compatible with the disinfection of medical devices with fragile surfaces (screen, electrical contacts). The disinfectant products concentration must be compliant with the appropriate hospitals & clinics standard practices. The Spiderflash-t holster bag is single-use & disposable and should not be washed or reused. Under no circumstances should Spiderflash-t, cables or cards be sterilized. CAUTION: If the protocol used requires disinfection of the electrical contacts (contacts of battery of the recorder and the contacts of SD card) it is essential to carefully dry these contacts before re-using the Spiderflash-t and the SD card.
CAUTION: − Never put Spiderflash-t in a liquid or a disinfecting solution. − Never put Spiderflash-t and its accessories in an autoclave.
4.6.2
Recommendations We recommend using disinfectant pre-filled wipes. For an effective disinfection, it is necessary to respect the recommended use by the manufacturer. In the normal conditions of use, the employment of this type of product does not alter the functions and the characteristics of our devices and accessories, it is however possible to notice in the long term a change of color of the plastic case. These modifications are essentially due to the presence of chloride ions and ethanol in this type of solution.
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4. PRECAUTIONS OF USE AND WARNINGS
4.7
CARE AND REPAIR OF THE DEVICE Class IIA device according to the EEC 93/42 directive and thus does not require any particular preventive maintenance. If the device fails to work properly, contact your local SORIN GROUP affiliate, or the SORIN GROUP After-Sales Service department. Do not unscrew the plastic case of the device under any circumstances and do not attempt to repair or modify mechanical or electrical parts of the device since this may lead to malfunctioning.
4.8
WARRANTY Spiderflash-t and its SD cards are guaranteed for parts and labor for two years from the date of delivery. After-Sales Service is free of charge to repair any defaulting device within the warranty condition. After-Sales Service still available after the warranty has expired but with a fee for repair.
NOTE: The warranty is only valid under the condition that no attempts have been made to open or repair the device. The warranty will be void if the device or the cards have been used contrary to this user manual recommendation. Damaged, bent or dust-polluted SD cards are not covered by warranty. Only SORIN GROUP cards are warranted.
4.9
END OF LIFE When the Spiderflash-t reaches the end of its life time, it should be returned to SORIN GROUP for appropriate recycling. The batteries should be recycled as appropriate and according to the local regulation and/or procedures. ECG cables and single use holster bag should be disposed of appropriately. The Spiderflash-t parts and accessories do not contain mercury or mercury compounds.
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5. USER PROFILE
5.
USER PROFILE Any person who followed the required training based on the local regulation. Training completion and effectiveness are under his/her medical supervisor responsibility.
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6. GENERAL DESCRIPTION
6.
GENERAL DESCRIPTION 6.1
ELEMENTS OF SPIDERFLASH-T
Infrared Receptor / Status LED (1)
Transtelephonic Transmission Send button (2)
Patient Activated event button (3)
Acoustic transmitter for Transtelephonic Transmission / Beeper for Status Check (4)
Figure 2
SORIN GROUP SD card (5)
Recording LED of data on the card (6)
On/Off button (7)
AAA battery (8) Patient cable (9)
Figure 3
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6. GENERAL DESCRIPTION
6.2
DESCRIPTION OF SYMBOLS ON THE CASE The following pictograms are present on the box of Spiderflash-t: This icon is used to call your attention to a particularly important point. This icon alerts you to a hazard that may result in equipment damage or personal injury. Carefully read the instructions provided with this icon. Manufacturer Indicates device is classified as type B (60601-1 IEC). Refers to the serial number of device. The user must refer to the Spiderflash-t user’s manual before handling. Indicates the On/Off switch The equipment must be recycled according to European Directive 2002/96/EEC CE mark: Spiderflash-t is in conformity with directive 93/42/CEE. 0459
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6. GENERAL DESCRIPTION
6.3
HOW TO OPEN SPIDERFLASH-T The next figures show how to open Spiderflash-t in order to access to the battery, SD card and on/off button. The device should only be opened by a trained technician. The patient should be instructed not to remove the cover under any circumstances.
Figure 4
Figure 5
NOTE: It is strongly recommended to follow instructions shown above in Figure 4 then Figure 5 in order to carefully open Spiderflash-t, step by step, without breaking. Inappropriate opening leading to plastic case breaking will not be covered by the warranty under any circumstances.
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6. GENERAL DESCRIPTION
6.4
CABLE INSERTION AND EXTRACTION The insertion (first A then B) and extraction (first C then D) of the patient cable should be done as indicated in the picture.
C D A B
Figure 6
When not in use, Spiderflash-t can be stored without disconnecting the patient cable from its connector.
6.5
BATTERIES AND RECHARGEABLE BATTERIES Open the recorder. Insert the AAA 1.5V battery in the battery compartment by respecting the polarity as marked in the compartment (see next figure). AAA
6.5.1
Alkaline or Lithium batteries SPF-t is powered by an alkaline or a lithium battery AAA of 1.5 V. A new alkaline battery ensures a 2 week recording or more depending on the protocol used. Lithium batteries are reported to last longer & should be a privileged choice. NOTE: The use of a new battery is strongly recommended for each new recording in order to ensure the duration announced above. With a Lithium battery, it is possible to reach 40 days under certain conditions of recording and environment (See paragraph 3.2 - Recording duration – page 7).
6.5.2
Rechargeable batteries Spiderflash-t can be powered with rechargeable AAA batteries. A capacity of 700mA/h or more is recommended. Rechargeable batteries have a reduced capacity compared to alkaline batteries. Rechargeable batteries capacity decreases over time with usage and the type of charger used. The duration of the monitoring period may therefore be reduced if rechargeable batteries are used.
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6. GENERAL DESCRIPTION
6.6
INTERNAL MEMORY BATTERY Spiderflash-t contains an internal battery recharged by the 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. NOTE: In the event of non-utilization of the recorder for more than 1 month, it is recommended to remove the AAA battery to avoid electrolyte leak (See § 4.2 page 8). Consequently, If the device is stored for a very long period of time, the internal battery runs flat & therefore the recorder does not start when re-using. It is then necessary to insert a new battery in the recorder to recharge the internal memory battery before use. According to the level of discharge of the internal battery, it is necessary to wait for a few minutes up to a few hours to be able to start Spiderflash-t. In this case it is strongly recommended to use the HookUp IR mode (See § 10 page 28) in order to completely initialize the recorder. Date & time of the recorder should be re-set appropriately by using HookUp before starting a new recording.
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7. PATIENT USE
7.
PATIENT USE Before connecting the electrodes on the chest of the patient, insert Spiderflash-t in its single use holster to be carried around the neck or on the belt.
Figure 7
7.1
NECK POSITION Spiderflash-t is carried by the patient for several days up to several weeks and is in direct contact with the skin of the patient. A single use and disposable neck holster has been designed to guarantee maximum comfort and hygiene for the patient and to protect the recorder from the sweat of the patient. Spiderflash-t is solidly maintained in the holster locked by a simple metal clip.
Place the holster around the neck according to the picture (on the left). Adjust the string length so that Spiderflash-t is located at the top of the patient’s sternum.
Figure 8
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7. PATIENT USE
7.2
BELT POSITION
Figure 9
Plug the plastic clip on the back of the holster then insert the Spiderflash-t. Cut the string with scissors and use the RC013 long cable. The patient cable being long, the recorder will be more sensitive to the electromagnetic disturbances and the movements of the patient. It is possible to limit these effects by fixing the cable with an adhesive tape.
7.3
ELECTRODE PLACEMENT The information relating to the installation of the electrodes are provided as an indication only. It is advisable to check that the amplitude of the ECG is sufficient enough to allow an analysis in real time of the ECG signal under the best possible conditions. By default Spiderflash-t uses derivation A (electrodes white & red), it is possible to select derivation B by using the HookUp software with the modes HookUp IR or HookUp CS. In anonymous mode, the derivation A is selected by default and cannot be modified. The user can check the quality and the amplitude of the ECG using the HookUp software via HookUp IR mode. With HookUp CS and Anonymous modes, control is carried out by a beep emitted when Spiderflash-t recognizes a QRS. This function is available during the preparation phase only (before pressing the green button of the recorder to start the recording (See § 11 & 12)). To ensure a high quality of ECG recording, patient skin preparation must be meticulously done. The same rule applies for electrode placement and cable connection. Rub the skin gently and clean it appropriately to obtain a good contact with the electrode in order to minimize the effects generated by muscular movements and electromagnetic disturbances. The electrodes must be applied carefully, in order to avoid air bubbles, likely to prevent a good contact.
SORIN – SPIDERFLASH-T –HOOKUP – O041D
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