MicroPort CRM SORIN SPIDER SAS User manual

Spider SAS
Apnea & Rhythm recorder
US R MANUAL

TAB E OF CONTENTS
1. INTRODUCTION........................................................................................................ 6
Typography convention .............................................................................................. 6
Description of symbols on the case............................................................................ 6
2. DEFINITIONS............................................................................................................. 8
Acronyms and definitions ........................................................................................... 8
Abbreviations (rhythm) ............................................................................................... 8
Abbreviations (Sleep apnea) ...................................................................................... 9
Other useful abbreviations ......................................................................................... 9
3. SPIDER SAS OVERVIEW ....................................................................................... 10
Presentation and intended use................................................................................. 10
Performances ........................................................................................................... 11
Contraindications and side effects ........................................................................... 11
4. PRECAUTIONS FOR USE AND MAINTENANCE .................................................. 12
Storage and Transportation...................................................................................... 12
Conditions for use .................................................................................................... 12
lectromagnetic environment................................................................................... 13
Care and repair of the device ................................................................................... 13
Warranty................................................................................................................... 13
nd of Service .......................................................................................................... 14
US Federal Communications Commissions (FCC) and Industry Canada................ 14
5. C EANING............................................................................................................... 16
Spider SAS and Physio Hub .................................................................................... 16
SpO2Sensor............................................................................................................. 16
Piezo ffort Sensor for respiration ........................................................................... 17
Nasal cannula and filter............................................................................................ 17
Bag and fabric parts ................................................................................................. 17
Disinfection............................................................................................................... 17
6. USER PROFI E ....................................................................................................... 19
7. GENERA DESCRIPTION ...................................................................................... 20
Spider SAS parts...................................................................................................... 20
Physio Hub parts ...................................................................................................... 20
Bluetooth dongle ...................................................................................................... 21
Hookup RS software ................................................................................................ 21
How to open Spider SAS.......................................................................................... 21
How to close Spider SAS ......................................................................................... 22
CG cable insertion and extraction.......................................................................... 22
Batteries ................................................................................................................... 22
1.1.
1.2.
2.1.
2.2.
2.3.
2.4.
3.1.
3.2.
3.3.
4.1.
4.2.
4.3.
4.4.
4.5.
4.6.
4.7.
5.1.
5.2.
5.3.
5.4.
5.5.
5.6.
7.1.
7.2.
7.3.
7.4.
7.5.
7.6.
7.7.
7.8.
SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F 3

8. PATIENT USE.......................................................................................................... 24
Description ............................................................................................................... 24
Recommended position............................................................................................ 24
lectrode placement................................................................................................. 25
Chest belt placement................................................................................................ 26
Abdominal belt placement ........................................................................................ 26
Nasal cannula placement ......................................................................................... 26
Finger pulse oxymeter placement ............................................................................ 26
Positioning of Spider SAS & accessories................................................................. 28
9. HOW TO PAIR SPIDER SAS (WINDOWS)............................................................. 29
Description ............................................................................................................... 29
Belkin Bluetooth interface......................................................................................... 30
Native Bluetooth interface ........................................................................................ 31
Bluegiga Bluetooth interface .................................................................................... 32
Installation of HookUp RS software.......................................................................... 33
10. STARTING A RECORDING WITH HOOKUP RS.................................................... 35
General Description.................................................................................................. 35
Launching HookUp RS............................................................................................. 37
CGs screen ............................................................................................................ 38
Belts & Respiration screen ....................................................................................... 40
Oxygen Saturation and plethysmography screen .................................................... 41
Steps to setup and start a recording with 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 recording in Anonymous mode .............................. 44
Conditions for Starting the monitoring of SAS in Anonymous mode ........................ 44
Starting the recorder in Anonymous mode............................................................... 45
12. STOPPING A RECORDING .................................................................................... 47
Spider SAS paired with computer ............................................................................ 47
Stopping Spider SAS without HookUp RS ............................................................... 47
13. SOFTWARE, HARDWARE AND ACCESSORIES.................................................. 48
14. TECHNICA SPECIFICATIONS.............................................................................. 49
Description ............................................................................................................... 49
lectrical characteristics........................................................................................... 49
Mechanical characteristics ....................................................................................... 49
Characteristics of acquisition.................................................................................... 49
Radio quipment mission ...................................................................................... 50
8.1.
8.2.
8.3.
8.4.
8.5.
8.6.
8.7.
8.8.
9.1.
9.2.
9.3.
9.4.
9.5.
10.1.
10.2.
10.3.
10.4.
10.5.
10.6.
10.7.
11.1.
11.2.
11.3.
11.4.
11.5.
12.1.
12.2.
14.1.
14.2.
14.3.
14.4.
14.5.
4 SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F

15. APPENDIX 1: PATIENT RECOMMENDATIONS .................................................... 51
Pediatric use............................................................................................................. 51
Reminders ................................................................................................................ 51
Nasal cannula........................................................................................................... 51
How to connect finger sensor to φ Hub.................................................................... 52
Patient Booklet ......................................................................................................... 53
16. APPENDIX 2: E ECTROMAGNETIC COMPATIBI ITY......................................... 54
Guidance and manufacturer's declaration................................................................ 54
Guidance and manufacturer's declaration: cable length .......................................... 54
Guidance and manufacturer's declaration: electromagnetic emissions ................... 55
Guidance and manufacturer's declaration: magnetic and electromagnetic immunity55
Guidance and manufacturer's declaration: electromagnetic immunity, portable RF
equipment................................................................................................................. 56
Spider SAS and mobiles (recommendations) .......................................................... 58
15.1.
15.2.
15.3.
15.4.
15.5.
16.1.
16.2.
16.3.
16.4.
16.5.
16.6.
SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F 5

1. INTRODUCTION
TYPOGRAPHY CONVENTION
This manual often refers to screenshots, originated from the programming software HookUp
RS used in its initial nglish version. The references to these screens are displayed in nglish
and in the local language; they are identified by the following symbols:
[ ]: nglish (original text in the screenshots - bold font).
{ }: Local language of the labels displayed in the screenshots.
DESCRIPTION OF SYMBO S ON THE CASE
The following pictograms are displayed on the Spider SAS 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 instructions provided with this icon.
Manufacturer
Device classified as type BF (60601-1 I C).
Serial Number of device
Refer to the user manual before handling.
White symbol on a blue background.
Consult the documentation and manual enclosed in the packaging.
Instructions for use available on CD-ROM
On/Off switch
The equipment must be recycled according to uropean Directive
2012/19/ U.
C mark: product is compliant with directive 93/42/ C.
1.1.
1.2.
1. INTRODUCTION
6 SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F

Medical equipment with respect to electric shock, fire, and mechanical haz-
ards, only in:
― AAMI/ S 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. INTRODUCTION
SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F 7

2. DEFINITIONS
ACRONYMS AND DEFINITIONS
BT Bluetooth(1): Generic term for naming all types of wireless interfaces according to Blue-
tooth consortium specifications (regardless of the Bluetooth protocol version).
BT E
or
BT 4.0
Bluetooth®(1) Low nergy, also called Bluetooth 4.0., enables HookUp RS to commu-
nicate with Spider SAS.
ev vent button located on the front of Spider SAS. Intended for use by the patient when
he/she wants to highlight a particular moment (symptom or relevant moment). When
the button is pressed, Spider SAS creates a specific user mark which will be displayed
in Synescope 3.30 or higher.
HookUp
RS
Lets the users program the Spider SAS recorder and check the quality of signals from
the connected sensors.
R: Rhythm – S: Sleep.
HR
(bpm)
Heart rate trend. A mean heart rate curve is calculated every minute (light line) and
maximum and minimum values over the same period (dark line).
µSD Micro SD Card: delivered in plastic box with SD card adapter.
φ Hub Physio Hub.
SAS
Option
Software option embedded in Synescope 3.30 to analyze Spider SAS recordings.
Spider
SAS
SAS: Sleep Apnea System. Multi-settings recorder dedicated to sleep apnea (pauses
in breathing or shallow breathing while the patient sleeps).
(1) The Bluetooth name and the Bluetooth trademark are owned by Bluetooth SIG.Inc
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. qual 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 dur-
ing a recording. These may be periods of atrial fibrillation, atrial flutter or sinus arrhyth-
mia.
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 trend bar’s 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 calcu-
lation of Min/Max HR. If not enough RR values are available, 2 values are used.
2.1.
2.2.
2. D FINITIONS
8 SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F

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.
ABBREVIATIONS (S EEP APNEA)
Apisode of apnea.
AHI Apnea Hypopnea Index.
Hpisode of hypopnea.
ODI Oxygen Desaturation Index (calculated from O2saturation values).
SDB Sleep Disordered Breathing
SaO2Saturation of Oxygen in hemoglobin cell.
SpO2Peripheral capillary Oxygen Saturation (indirect measurement of SaO2).
OTHER USEFU ABBREVIATIONS
AA Arrhythmia Assessment: part of CRM business line involved in development, manufactur-
ing and selling of non-invasive products (Blood Pressure monitor, vent recorder, Holter
recorder, Sleep Apnea recorder).
MRI Magnetic Resonance Imaging
RF Radio Frequency (disturbances)
2.3.
2.4.
2. D FINITIONS
SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F 9

3. SPIDER SAS OVERVIEW
PRESENTATION AND INTENDED USE
Spider SAS is an CG and Apnea monitor able to record relevant physiologic signals for
evaluating Sleep Apnea Syndrome.
Spider SAS features a continuous 7-channel recording:
― CG (2 channels)
― Thoracic respiratory effort
― Abdominal respiratory effort
― O2 Saturation
― Plethysmography
― Oral/Nasal Pressure
― Body position
The recorded data is stored on the µSD card, ready to be easily analyzed by Synescope
software (version 3.30 or higher) with SAS option to provide reports of Sleep Apnea with CG
arrhythmia analysis.
Spider SAS is indicated for patients presenting (or suspected with) sleep apnea disease.
It can also record markers when the patient presses the “ev” button.
Data analysis
The SAS Synescope Option software is used to download, visualize and analyze the data
recorded with Spider SAS. If necessary, the polygraph report can be modified and printed by
the user.
3.1.
3. SPID R SAS OV RVI W
10 SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F

PERFORMANCES
Main performance of Spider SAS and PhysioHub 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 R SAS OV RVI W
SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F 11

4. PRECAUTIONS FOR USE AND MAINTENANCE
STORAGE AND TRANSPORTATION
The Spider SAS is packaged as outlined in the packaging chapter at time of delivery.
The following table shows the conditions of storage and transportation for Spider SAS:
Storage and transportation Temperature Humidity Pressure
Recorder -20° ～ 65°C 5% ～ 85%
non condensing
500 hpa ～1060 hpa
μSD card -20° ～ 65°C 8% ～ 95%
non condensing
500 hpa ～1060 hpa
lectrode 5° ～ 30°C NA NA
Cable 10° ～ 40°C 25% ～ 90%
non condensing
NA
A protective bag is needed in case of extremely humid environment.
Remove the battery before storing Spider SAS.
CAUTION: If stored over a prolonged period, remove the battery from Spider SAS.
According to the duration and conditions of storage and the battery quality type, there is a
risk of electrolyte leak into the Spider SAS’s plastic case. In such a case the device must
be returned to the MicroPort After Sales Department for repair. 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 of it following local environmental
legislation and/or the intended procedures. If the leak is not significant (no oxidation on
the electrical contacts of the battery), it is possible to clean it with a damp cloth, and
then carefully dry the cleaned parts. In the event of traces of significant oxidation, it is
strongly recommended not to use the device (risk of recording failure) and return it to
MicroPort After Sales. Repair is excluded from the warranty and a fee will be charged.
CONDITIONS FOR USE
CAUTION: If a patient carrying a Spider SAS recorder needs to be defibrillated, it is
mandatory that the recorder’s electrodes be removed before using the defibrillator. Spider
SAS is not protected from the effects of external defibrillation shocks or against high
frequency signals or strong electromagnetic disturbances.
The table below illustrates conditions for use for Spider SAS
Use Temperature Humidity Pressure
Recorder and
µSD card
0° ～ 38°C 10% ～ 95%
no condensing
700 hpa ～1060 hpa
The correct operation of Spider SAS is only guaranteed when used with µSD cards provided
by MicroPort.
4.1.
4.2.
4. PR CAUTIONS FOR US AND MAINT NANC
12 SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F

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.
CAUTION: Spider SAS shall not be used in environments with flammable anesthetic
mixtures containing oxygen or nitrous oxide.
E ECTROMAGNETIC ENVIRONMENT
The use of portable and mobile RF communication equipment (e.g. cellular phones) can
affect the Spider SAS since the recorded signals may be disturbed due to electromagnetic
interference.
CAUTION:The device shall not be used in the presence of ionizing radiations (x-rays,
gamma rays...) or MRI System that could damage Spider SAS, φ Hub and/or µSD card.
Remove sensors and devices before starting any MRI procedure.
Concerning the electromagnetic emissions and the level of the immunity of the recorder, see
Appendix 2: lectromagnetic compatibility.
CARE AND REPAIR OF THE DEVICE
No particular preventive maintenance is required 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 affiliate, or the MicroPort After-
Sales Service. Do not unscrew the plastic case of the device under any circumstances and
do not attempt to repair or modify mechanical or electrical parts since this may lead to
malfunctions.
WARRANTY
The Spider SAS, Physio Hub and µSD card are guaranteed for two years from the date of
delivery. After-Sales Service shall repair any faulty device within the warranty condition free
of charge. After-Sales Service shall still be available after the warranty has expired but with a
fee for repair.
All reusable sensors, in this case, oximeter and piezo sensors, are guaranteed for 1 year.
All reusable accessories are guaranteed for 3 months including CG cables, Bluetooth
dongle, bags, pouches, blue and beige belts.
The 1-year warranty applies neither to consumables nor to single-use devices.
NOTE: The warranty is only valid under the condition that no attempts have been made to
open or repair the device. The warranty shall be void if devices or cards have been used
contrary to this user manual’s recommendation.
Only µSD cards provided by MicroPort are under guarantee.
4.3.
4.4.
4.5.
4. PR CAUTIONS FOR US AND MAINT NANC
SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F 13

Damaged, bent or dust-polluted µSD cards and sensors are not covered by warranty.
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.
CG cables, accessories and reusable holster bag should also be disposed of appropriately.
US FEDERA COMMUNICATIONS COMMISSIONS (FCC) AND
INDUSTRY CANADA
UNITED STATES
This equipment has been tested and found to comply with the limits for a Class B digital
device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to radio
communications.
However, there is no guarantee that interference will not occur in a particular installation. If
this equipment does cause harmful interference to radio or television reception, which can be
determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one of the following measures:
― Reorient or relocate the receiving antenna.
― Increase the separation 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/TV technician for help.
CAUTION: This equipment may not be modified, altered, or changed in any way without
signed written permission from MicroPort CRM. Unauthorized modification may void the
equipment authorization from the FCC and will void the MicroPort CRM warranty.
This equipment complies with FCC radiation exposure limits set forth for an uncontrolled
environment and meets the FCC radio frequency (RF) xposure Guidelines.
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.
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.) is not more than that
4.6.
4.7.
4. PR CAUTIONS FOR US AND MAINT NANC
14 SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F

necessary for successful communication.
This equipment complies with IC radiation exposure limits set forth for an uncontrolled
environment and meets RSS-102 of the IC radio frequency (RF) xposure rules.
This equipment has very low levels of RF energy that is deemed to comply without testing of
specific absorption rate (SAR).
Le présent appareil est conforme aux CNR d’Industrie Canada applicables aux appareils
radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes :
1. il ne doit pas produire de brouillage, et
2. l’utilisateur du dispositif doit être prêt a accepter tout brouillage radioélectrique reçu,
même si ce brouillage est susceptible de compromettre le fonctionnement du dispositif.
Conformément à la réglementation d’Industrie Canada, le présent émetteur radio peut
fonctionner avec une antenne d’un type et d’un gain maximal (ou inférieur) approuvé pour
l’émetteur par Industrie Canada.
Dans le but de réduire les risques de brouillage radioélectrique à l’ intention d’autres
utilisateurs, il faut choisir le type d’antenne et son gain de sorte que la puissance isotrope
rayonnée équivalente (p.i.r.e.) ne dépasse pas l’intensité nécessaire à l’établissement d’une
communication satisfaisante.
Cet équipement est conforme aux limites d’exposition aux rayonnements énoncées pour
un environnement non contrôlé et respecte les règles d’exposition aux fréquences
radioélectriques (RF) CNR-102 de l’IC.
Cet équipement émet une énergie RF très faible qui est considérée comme conforme sans
évaluation du débit d’absorption spécifique (DAS).
4. PR CAUTIONS FOR US AND MAINT NANC
SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F 15

5. C EANING
CAUTION: A recently cleaned device must be dried carefully to avoid any oxidation of the
electrical contacts before long term storage.
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.
After being cleaned, the materials must be carefully dried before storage and use. Spider SAS
and Physio Hub are not waterproof devices, therefore they should not be immersed in liquid.
CAUTION: Do not immerse the snap-on cable clips in a cleaning or disinfectant solution.
This method considerably shortens the life of cables and causes an important internal
oxidation between the clip and the wire of the cable. The quality of the CG signal could be
affected.
SPO2SENSOR
Reusable PureLight® Sensor is
manufactured by Nonin® Medical Inc.
Cleaning instructions are available in the
"Instructions for use" included with the sensor
or on the Nonin website
(http://www.nonin.com/ProductCleaning).
CAUTION: Do not submerge or immerse sensor or connector plug. Do not place device in
liquid or clean it with agents containing ammonium chloride or products that are not listed in
the User’s Guide supplied by Nonin Inc.
Clean reusable sensors between patients or as needed:
1. Use a soft cloth with a 10% bleach/90% water solution (household bleach < 10% sodium
hypochlorite).
2. Wipe away from connector plug. Do not turn Soft Sensors inside out.
3. Leave the Soft Sensors to dry completely before next use
5.1.
5.2.
5. CL ANING
16 SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F

PIEZO EFFORT SENSOR FOR RESPIRATION
This sensor is manufactured by SleepSense.
The Piezo Film ffort 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)
NASA CANNU A AND FI TER
Nasal cannula, Oral & Nasal cannula and filter are disposable and single-use parts. After use,
dispose of them according to local environmental recommendations.
BAG AND FABRIC PARTS
The Spider SAS holster bag (RG017) is reusable 10 times or more and can be washed at
30°C and/or disinfected.
DISINFECTION
Disinfectant product manufacturers provide specific indications for their appropriate use
with medical devices. Their compatibility 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 preserving the duration of life and efficiency of Spider SAS and to
guarantee a high level of hygiene for every patient. We recommend using wipes instead of
liquid solution.
CAUTION: Do not use products if they are not C approved according to directive 93 / 42 /
C. C is compulsory if the product is specifically intended for the disinfection of Medical
Devices.
Disinfect the plastic case, cable and µSD card with a single-use disinfectant wipe which
complies with the current standards:
― bactericide: N1040, N 1276
― virucide: NFT72-180, N 14476
― fungicide: N 1275
― levuricide: N 1650
The solution used must be compatible with the disinfection of medical devices with fragile
surfaces (screen, electrical contacts). The disinfectant concentration of products must be
compliant with the appropriate hospitals’ & clinics’ standard practices.
5.3.
5.4.
5.5.
5.6.
5. CL ANING
SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F 17

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.
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, Physio Hub, sensors, cables or cards.
NOTE: In normal conditions of use, the disinfectant solution does not alter the functions and
characteristics of our devices and accessories, however, the plastic case may discolor
slightly in the long term. These modifications are essentially due to the presence of chloride
ions and ethanol in some solutions.
5. CL ANING
18 SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F

6. USER PROFI E
Any person who followed the required training based on the local regulation. Training
completion and effectiveness are under his/her medical supervisor’s responsibility.
6. US R PROFIL
SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F 19

7. GENERA DESCRIPTION
SPIDER SAS PARTS
➊ Status L D (green/orange) ➎ µSD card ➒ Reset switch
➋ Send button ➏ Red writing led ➓ AAA Alkaline or Lithium battery
➌ vent Button ➐ On/Off button ⑪ Physio Hub connector
➍ Loudspeaker ➑ Open hood switch ⑫ CG cable connector
PHYSIO HUB PARTS
➊Connector for belt(s)
➋Sub 9D connector for pulse
oxymeter sensor
➌Luer lock connector for nasal
cannula
➍Spider SAS connection
7.1.
7.2.
7. G N RAL D SCRIPTION
20 SPID R SAS – PHYSIO HUB – HOOKUP RS – U908F