CADWELL Sleepmate User manual
RIPmate™ Respiratory Eort
Instructions for Use (IFU)
Cadwell®Sleepmate
Helping you help others
Contents Page
English ............................................................................................................................................................... 4
Dansk................................................................................................................................................................. 9
Deutsch.............................................................................................................................................................. 13
Español.............................................................................................................................................................. 18
Suomi ................................................................................................................................................................ 23
Français.............................................................................................................................................................. 28
Italiano............................................................................................................................................................... 33
Nederlands........................................................................................................................................................ 38
Norsk ................................................................................................................................................................. 43
Português........................................................................................................................................................... 48
Svenska.............................................................................................................................................................. 53
EN
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Intended Use
The Cadwell Sleepmate™respiratory effort sensor is intended to detect respiratory effort from
chest or abdomen movement during sleep research and clinical studies of sleep. This Belt is
intended for use in supervised medical settings.
Instruction for use
aHow to Adjust the Size
The shortest length of the belt is when the sliders are positioned at each end of the belt, as
illustrated in figure: Shortest position
For ease of adjustment, it is best to keep the sliders centered (equal distance from the end of
belts to each slider) in the belt to ensure ease of adjustment.
bLengthening the Belt
1. Move the left slider towards the center of the belt. A loop will be formed as shown in
the picture.
2. Holding the left end of the belt, pull the right end to tighten the loop.
cShortening the Belt
To shorten the belt, move the sliders apart from each other towards the belt’s ends.
dPatient Attachment
The Belts are intended to be worn over patient nightclothes.
The belt should fit snugly around patient without being uncomfortable.
1. Adjust belt as described above for proper fit.
2. Wrap 1 belt around patient Abdomen and snap buckles together.
3. Plug the 1.5mm touch proofed plug at the end of the wire set into the belt connectors
near each buckle; plug the other end, with keyhole connector into the RIPmate™
Abdomen module.
4. Plug the module output into the appropriate bipolar input of your polygraph. The red
touch proof is plugged into (+) input, and the black into (-) input.
5. Repeat steps 1-4 for the Thorax belt, wrapping this belt around the patient chest.
EN
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Note: Do not use two abdomen or two thorax modules in the same
recording. This will cause interference between the two sensors, resulting in
bad signals.
Warnings
• Do not use damaged belts or cables.
• Do not use the device in an MRI environment. Do not use the device in an explosive
environment, i.e. in the presence of flammable liquids or gases, such as anesthetic mixture
with air or with oxygen or nitrous oxide
• The RIPmate™ systems are only to be connected to an electrically isolated input. Do not
plug cables into electrical outlets as this could result in serious electrical shock.
• The device contains a battery and must therefore be disposed of properly. Local, state or
national laws may prohibit disposal of batteries in ordinary trash. Contact your local waste
authority for information regarding available recycling and disposal options.
• The belts shall be worn over night clothes.
• The RIPmate™ system is non-repairable by the user and the user’s service personnel.
Contact Sleepmate in case of device failure.
• Portable and mobile RF communications can affect the performance of the device.
• No user serviceable parts inside. Serviced by Sleepmate and authorized parties only.
Warranty void if opened.
Cleaning
No part of the RIPmate™ system requires sterilization.
Sensor
The sensor may be wiped clean with hospital grade cleaner that is not corrosive to
plastic or metal, and then dried with a clean, dry cloth. Do not immerse the sensor in
liquid and avoid contact of the cleaning solution with the connectors.
EN
6
Belts
The belts may be hand washed in warm (not hot) solution of household laundry detergent,
and then air dried. Care should be taken to fully dry safety jacks after cleaning.
Cables
The cables may be wiped clean with a moist cloth using hospital grade cleaner.
Do not immerse the cables in liquid and avoid contact of the cleaning solution with the
connectors.
Storage
Proper storage of the RIPmate™ system will increase life of the product. To protect the belt
and the cable from damage, follow these guidelines for storage:
• Do not fold the belt tightly together (see below) as this could damage the wire weaved in
the belt. Hanging on a hook is the recommended storage
method.
• Do not wrap the cable around the sensor as it may cause the cable to
break.
• To save battery power, the module MUST be disconnected from the belt
when not in use. When disconnecting cable from belt, grasp both belt
connector & cable connector securely and pull out. Do not pull on wire.
EN
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Technical Specications
Description Properties
Physical Properties
Belt length Adjustable 24”-79” (60-200cm)
Belt material Elastic band with Insulated wire
Cable length 80” (205cm)
Cable material PVC jacketed; ZIP-style cord
Module Box: ABSCable: PVC jacketed; Zip Style cord
Battery 3V Lithium (integrated in the device)
Battery Life The battery life is estimated to be 3000 hours or 375 eight hour studies. The
battery is activated once the sensor module is connected to the belt.
Enviromental Specifications
Temperature Operation : 40°F to 120°F (+5°C to +50°C)
Storage: 0°F to 120°F (-20°C to +50°C)
Relative Humidity Operation : 15-95% (non-condensing)
Storage: 10-95% (non-condensing)
Pressure Withstands atmospheric pressures from 7.3 psi to 29 psi
Output Specifications
Output Signal Maximum signal amplitude: ±5mV
Frequency Range 0.2 to 3 Hz
Sensitivity Approximately 50μV/mm
Polygraph Settings
Sensitivity Adjustment of the sensitivity up or down is typically required. Response is
dependent upon variables such as sensor application and patient effort.
Low Frequency Filter /
Time Constant
0.16 Hz (or 1 second or longer) Shorter time constants or higher low
frequency filter settings will significantly attenuate waveforms
High Frequency Filter 35 Hz.
EN
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Caution Statement:
US Federal Law restricts this device to sale by or on the order of a physician. This product is
for diagnostic purposes only and is not intended to be used as an apnea monitor or in a life supporting or
sustaining capacity.
DA
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Tiltænkt anvendelse
Cadwell Sleepmate™respirationsbevægelsessensor er beregnet til at registrere
åndedrætsbevægelser fra bryst eller mave under søvnforskning og kliniske søvnstudier. Dette
bælte er beregnet til anvendelse under overvågede medicinske forhold.
Betjeningsvejledning
aTilpasning af størrelsen
Bæltets korteste længde opnås, når gliderne befinder sig i hver ende af bæltet, som vist
nedenfor: Korteste indstilling
For at lette tilpasningen er det bedst at holde gliderne centreret på bæltet
(samme afstand fra bæltets ender til hver glider).
bForlængelse af bæltet
1. Før venstre glider mod bæltets midte. Der dannes en løkke som vist på billedet.
2. Hold i venstre ende af bæltet, og træk i højre ende for at stramme løkken.
cAfkortelse af bæltet
For at afkorte bæltet skal gliderne føres væk fra hinanden mod bæltets ender.
dFastgørelse på patienten
Bælterne er beregnet til at kunne bæres over patientens nattøj.
Bæltet skal passe komfortabelt omkring patienten uden at stramme.
1. Tilpas bæltet til patienten som beskrevet ovenfor.
2. Vikl et bælte omkring patientens mave, og klik spænderne sammen.
3. Sæt det 1,5 mm berøringssikre stik for enden af ledningssættet ind i
bæltekonnektorerne nær hvert spænde, og sæt den anden ende med
nøglehulskonnektor ind i RIPmate™ mavemodulet.
4. Tilslut moduludgangen til den korrekte bipolære indgang på polygrafienheden. Den
røde berøringssikre konnektor sættes i (+)-indgangen, og den sorte i (-)-indgangen.
5. Gentag trin 1-4 for brystbæltet, idet dette bælte skal vikles omkring patientens bryst.
DA
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Bemærk: Benyt ikke to mave- eller to brystmoduler til samme registrering.
Dette vil skabe interferens mellem de to sensorer og dermed dårlige
signaler.
Advarsler
• Benyt aldrig beskadigede bælter eller kabler.
• Benyt ikke enheden i et MR-miljø. Benyt ikke enheden i et eksplosivt miljø, dvs. i nærheden
af brandbare væsker eller gasser, såsom anæstesiblanding med luft eller med ilt eller
lattergas.
• RIPmate™-systemerne må kun tilsluttes til en elektrisk isoleret indgang. Kablerne må ikke
tilsluttes til elektriske udgange, da dette kan medføre et alvorligt elektrisk stød.
• Enheden indeholder et batteri og skal derfor bortskaffes efter gældende retningslinjer.
Batterier bør ikke kasseres som normalt affald, men bør afleveres på en genbrugsstation
eller i indsamlingsbeholdere.
• Bælterne skal bæres over nattøjet.
• RIPmate™-systemet må ikke repareres af brugeren eller dennes servicepersonale. Kontakt
Sleepmate, hvis der opstår svigt i enheden.
• Bærbare og mobile RF-kommunikationsenheder kan påvirke enhedens ydelse.
• Enheden indeholder ingen dele, der kan repareres af brugeren. Må kun repareres af
Sleepmate og personer, der er autoriseret af Sleepmate. Garantien bortfalder, hvis
enheden åbnes.
Rengøring
Der er ingen dele af RIPmate™-systemet, der kræver sterilisering.
Sensor
Sensoren kan aftørres med et rengøringsmiddel af hospitalsstandard, som ikke virker
korroderende på plast eller metal, og derefter kan den tørres med en ren, tør klud.
Sensoren må ikke nedsænkes i væske. Rengøringsopløsningen må ikke komme i kontakt med
konnektorerne.
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