CAIRE Sprint, Hi Flow Stroller, Stroller User Manual

Sprint / Stroller / Hi Flow Stroller
User Manual (English)
2 - ENG PN MN236 A | User Manual
Sprint / Stroller / Hi Flow Stroller
Symbols Glossary
Operating temperature limitation of these units is -10°C to 40°C. Storage temperature limitation range is -40°C to 70°C. Reg. # 0632
Portable humidity range is 15 to 95%. Base humidity range is 30 to 75%. Reg. # 2620
Keep away from rain, keep dry. Reg. # 0626
Name and address of manufacturer. Reg. # 3082
Caution, consult accompanying docu­ments. Reg. # 0434A
Catalog Number. Reg. # 2493
Serial Number. Reg. # 2498
This way up. Reg. # 0623
Fragile, handle with care. Reg. # 0621
ISO 7010: Graphical symbols—Safety colors and safety signs—Registered safety signs
Frostbite may occur on contact with cold liquid or gaseous oxygen, or frosted parts. Warning low tempera­ture. To warn of low temperature or freezing conditions. Reg. # W010
The instruction manual must be read. Reg. # M002
Keep away from open ame, re,
sparks. Open ignition source and smoking prohibited. Reg. # P003
Do not smoke near unit or while operating unit. Reg. # P002
Type BF applied part (degree of protection against electric shock). Reg. # 5333
Warning. Reg. # W001
Council Directive 93/42/EEC; concerning medical devices
Authorized representative in the European Community
This device complies with the requirements of Directive 93/42/EEC concerning medical devices. It bears the CE marking as shown. This device complies with the re­quirements of Directive 2010/35/EU concerning medical devices. It bears the pi marking as shown.
ADR: European Agreement concerning the Inter­national Carriage of Dangerous Goods by Road
Non-toxic gas.
Hazard Oxidizing substances: re
intensifying risk.
Refrigerated Liquid, USP; Produced by Air Liquefaction
Internal Symbols
Keep unit well ventilated at all times
Keep away from ammable materials,
oil and grease.
IEC 60417: Graphical Symbols for use on equip­ment
Do not cover unit. These units nor­mally vent oxygen. No. 5641
21 CFR 801.15: Code of Federal Regulations Title 21
Federal law restricts this device to sale by or on the order of a physician.
Council Directive 2012/19/EU: waste electrical and electronic equipment (WEEE)
WEEE
IEC 60601-1: Medical electrical equipment Part 1 General requirements for basic safety and essential performance
Drip Proof IP22
This product may be covered by one or more patents, US and international. Please visit our website, Pat.: patents.cairemedical.com for listing of applicable patents.
PN MN236 A | User Manual 3 - ENG
Sprint / Stroller / Hi Flow Stroller
Specifications
• Mode of Operation: Continuous Flow
• Type of Protection Against Electrical Shock: Internally Powered Equipment
Degree of Protection Against Electrical Shock: Type BF Applied Part
• Classication According to the Degree of Protection Against Ingress of Water: IP22 – Ordinary
Equipment
Equipment not suitable for use in the presence of ammable mixtures
Product Specifications
Sprint Stroller Hi Flow Stroller
LOX Capacity 1.5 lb (0,68 kg) 3.0 lb (1,36 kg) 3.0 lb (1,36 kg)
Gaseous Equivalent Capacity
513 L 1026 L 1025 L
Weight, Empty 4.5 lb (2,04 kg) 5.0 lb (2,27 kg) 5.5 lb (2,49 kg)
Weight, Filled 6.0 lb (2,72 kg) 8.0 lb (3,63 kg) 8.5 lb (3,86 kg)
Height 11.75 in. (298 mm) 13.5 in. (343 mm) 13.5 in. (343 mm)
Dimensions 5-7/8"(149mm) D x 7.5"
(191mm) W
5-7/8"(149mm) D x 7.5" (191mm) W
5.875" (149 mm) D x 7.5" (191 mm) W
Typical use time at 2 LPM 4.3 hours 8.0 hours 8.0 hours
Operating Pressure 20 psi (137 kPa) 20 psi (137 kPa) 20 psi (137 kPa)
Normal Evaporation Rate 1.3 lb/ day (0,57 kg/ day) 1.3 lb/ day (0,57 kg/ day) 1.3 lb/ day (0,57 kg/ day)
Standard Flow Control Range
Off, .25, .5, .75, 1, 1.5, 2,
2.5, 3, 4, 5, 6 LPM
Off, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 15 LPM
Off, .5, 1, 2, 2.5, 3, 4, 6, 8, 10, 12, 15 LPM
Flow Rate Accuracy* +/- 10% +/- 10% +/- 10%
* This accuracy is only at 70F and 14.7 psig and with a calibrated accurate mass ow meter.
4 - ENG PN MN236 A | User Manual
Sprint / Stroller / Hi Flow Stroller
Warning Information
Important: Read this manual thoroughly before operating the Sprint/Stroller/Hi Flow Stroller. RX Only.
WARNING: THIS DEVICE IS NOT IN­TENDED FOR LIFE SUSTAINING USE.
WARNING: IF YOU FEEL THE EQUIPMENT IS NOT OPERATING PROPERLY, CALL YOUR HEALTH CARE PROVIDER. DO NOT ATTEMPT TO REPAIR OR ADJUST THE UNIT YOURSELF.
WARNING: DO NOT MODIFY THIS EQUIPMENT WITHOUT AUTHORIZATION FROM THE MANUFAC­TURER.
WARNING: IF CONTINUITY OF OXYGEN SUPPLY IS REQUIRED, ENSURE THAT AN ADEQUATE SUPPLY OF OXYGEN AND/OR A SECONDARY OXYGEN SUPPLY IS AVAILABLE AT ALL TIMES DURING THERAPY.
WARNING: DO NOT ALLOW SMOKING, CANDLES, OR OPEN FLAMES WITHIN 10 FEET (3 METERS) OF THE DEVICE, OR CLOSER THAN 8 INCHES (20 CM) FROM ANY SOURCE OF IGNITION.
WARNING: KEEP YOUR UNIT IN A WELL­VENTILATED AREA.
WARNING: DO NOT STORE LIQUID OXYGEN EQUIPMENT IN A CLOSET, CAR TRUNK, OR OTHER CONFINED AREA. DO NOT PLACE BLANKETS, DRAPERIES, OR OTHER FABRICS OVER EQUIPMENT.
WARNING: THIS PRODUCT CAN EXPOSE YOU TO CHEMICALS INCLUDING NICKEL, WHICH IS KNOWN TO THE STATE OF CALIFORNIA TO CAUSE CANCER. FOR MORE INFORMATION, GO TO WWW.P65WARNINGS.CA.GOV.
Caution: Use the Sprint/Stroller/Hi Flow Stroller only as directed by your doctor.
Caution: Federal law restricts this device to sale by or on the order of a physician.
The unit contains liquid oxygen which is extremely cold, almost -300°F (-184°C). Exposure to such a low temperature can cause severe frostbite.
Liquid and gaseous oxygen, though
nonammable, cause other materials to
burn faster than normal. This hazard, along with the low temperature of liquid oxygen, warrants certain safety precau­tions.
Keep ammable materials away from
this equipment. Aerosol sprays, oils and grease, including facial creams and pe­troleum jelly, ignite easily and may burn rapidly in the presence of oxygen.
Smoking while wearing an oxygen can­nula can cause facial burns and possibly result in death. Removing the cannula and placing it on clothing, bedding, sofas, or other cush-
ion material will cause a ash re when
exposed to a cigarette, heat source,
spark or ame.
If you smoke please: (1) turn off the portable, (2) take off the cannula, and (3) leave the room where the device is located.
In the event of an accidental tip-over, immediately but cautiously return the unit into an upright position if possible.
If any liquid oxygen is escaping, leave the area immediately and call your healthcare provider. Do not attempt to move the unit or stop the liquid oxygen from escaping.
Do not touch frosted parts of any unit.
Do not store or operate the portable coupled to the stationary unit.
Do not allow untrained personnel to handle or operate this device.
Use of this device is prohibited on com-
mercial passenger and cargo air ights
by the Federal Aviation Administration.
PN MN236 A | User Manual 5 - ENG
Sprint / Stroller / Hi Flow Stroller
Introduction
The Sprint, Stroller, and Hi Flow Stroller are in­tended for the administration of supplemental oxy­gen to the patient in the end user’s home and can also be used in institutions such as nursing homes or sub-acute care facilities. The Sprint/Stroller/ Hi Flow Stroller provide an ambulatory source of oxygen for an extended period of time.
The device is used by COPD patients or those with diminished breathing capacity. The device is prescribed to the patient. The device is sold to a provider that is trained to operate and service the Sprint/Stroller/Hi Flow Stroller. The provider trains the user.
The device is not intended for life support nor does it provide any patient monitoring capabilities. It is recommended to have an alternate source of supplemental oxygen in the event of mechani­cal failure. These portable devices also have a quick disconnect valve that can be coupled with
a reservoir lox device for translling the portable device. The reservoir unit is lled by your health
care provider.
This user manual contains the instructions for using the Sprint/Stroller/Hi Flow Stroller. Refer to the user manual supplied with the stationary unit for its operation.
NOTE: The service provider will assist with the initial setup and instruct proper handling and usage of the unit.
Sprint, Stroller and Hi Flow Stroller units
Controls
1. Electronic Liquid Level Gauge
2. Electronic Liquid Level Switch
3. Mechanical Liquid Level Gauge
4. Flow Control Knob
5. Oxygen Tube Connector
6. Vent Valve
7. Fill Connections (see next page for QDV
Identication)
8. Carrying Strap with Shoulder Pad
9. Condensation Pad
10. Condensation Cup
10
9
1
2
4
5
8
7
5
8
6 - ENG PN MN236 A | User Manual
Sprint / Stroller / Hi Flow Stroller
Quick Disconnect Valve (QDV) Identification
Portable
Connector
Stationary Connector
QDV Style
CAIRE Side Fill
SF Locking
LIFE-OX
TF Locking
PENOX
TAEMA
TF Push-On
PB
Operating Instructions
To Fill the Top Fill Sprint/Stroller/ Hi Flow Stroller
1. Clean the ll connectors on both the stationary
and the Stroller/Spirit/Hi Flow Stroller with a clean, dry, lint-free cloth.
Caution: The fill connectors must be dry, because moisture can cause your Sprint/ Stroller/Hi Flow Stroller and stationary unit to freeze together.
2. Make sure the ow control knobs on both the
Sprint/Stroller/Hi Flow Stroller and reservoir are in the off (0) position.
3. Position the ll connector in the upright position
over the stationary unit’s connector.
4. a. If your connector is a push-on: Lower the Sprint/Stroller/Hi Flow Stroller unit on to the stationary until you feel the connec­tor engage.
b. If the connector is a Penox or Life-Ox:
Rotate Sprint/Stroller/Hi Flow Stroller until you feel the connector engage. Then, care-
fully and rmly, rotate the Sprint/Stroller/Hi
Flow Stroller clockwise (
) while pressing
downward.
NOTE: Continued on step 6 in To Fill the Side Fill Sprint/Stroller/Hi Flow Stroller.
To Fill the Side Fill Sprint/Stroller/Hi Flow Stroller
1. Clean the ll connectors on both the stationary
and the Sprint/Stroller/Hi Flow Stroller with a clean, dry, lint-free cloth.
WARNING: THE FILL CONNECTORS MUST BE DRY, BECAUSE MOISTURE CAN CAUSE YOUR SPRINT/STROLLER/HI FLOW STROLLER AND STATIONARY UNIT TO FREEZE TOGETHER.
PN MN236 A | User Manual 7 - ENG
Sprint / Stroller / Hi Flow Stroller
2. Make sure the ow control knobs on both the
Sprint/Stroller/Hi Flow Stroller and reservoir are in the off (0) position
3. Make the Sprint/Stroller/Hi Flow Stroller ll con­nector is in the upright position to the stationary connector.
4. Rotate the Sprint/Stroller/Hi Flow Stroller coun­terclockwise (
) until you feel the pin and slot
engage.
5. Carefully and rmly rotate the Sprint/Stroller/Hi
Flow Stroller back to the upright position. Now the units are locked together.
NOTE: Continued on step 6.
NOTE: For push-on style connector, hold the unit in place throughout the fill.
6. Open the vent valve to begin lling your Sprint/
Stroller/Hi Flow Stroller. You should hear some oxygen escaping; do not worry. The hissing sound
you hear is perfectly normal.
NOTE: Liquid level gauge readings are most accurate 30 seconds or more after the Sprint/Stroller/Hi Flow Stroller is filled.
7. You may also see vapor around the connection. This is normal and is due to the great difference in temperature between the liquid oxygen and the warm air surrounding the units.
8. When the unit is full, close the vent valve. You can tell that the unit is full when the hissing sound changes in tone, and some liquid comes out of the vent line.
NOTE: Closing the valve after a nearly continuous stream of liquid is discharging fills the Sprint/Stroller/ Hi Flow Stroller most completely, but wastes some liquid oxygen.
NOTE: Closing the valve at the first sign of liquid discharge does not fill the Sprint/Stroller/Hi Flow Stroller as completely, but saves liquid oxygen.
9. For the push-on style connectors, push the re­lease button down until the units separate. For all other connectors rotate the unit until it separates from the stationary unit.
Portable Release Button (push-on style only)
8 - ENG PN MN236 A | User Manual
Sprint / Stroller / Hi Flow Stroller
Operating Instructions
(Cannula is not included.)
1. Push the cannula breathing tube rmly on to the
oxygen tube connector.
2. Adjust your cannula breathing tube to the proper position so that you will be able to breathe the oxygen comfortably.
3. Turn the ow control knob on top of the Sprint/
Stroller/Hi Flow Stroller/Hi Flow Stroller clock-
wise until the prescribed ow rate (numeral)
is visible in the knob “window” and a positive detent is felt.
Caution: Out-of-specification oxygen flow will result if the flow control knob is set between flow rates.
4. You should be receiving oxygen now. To stop ow of oxygen, turn the ow control knob coun­terclockwise to the off (0) position.
Caution: Always turn the flow control knob off (0) when not in use.
Caution: Check liquid level gauge only after the valve is closed.
Caution: If the Sprint/Stroller/Hi Flow Stroller is being refilled immediately after a period of use, fill it, and then wait 10 minutes after filling with the FCV set at zero for the pressure to stabilize. Then operate as normal.
WARNING: DO NOT OPERATE SPRINT/ STROLLER/HI FLOW STROLLER WHILE AT­TACHED TO THE STATIONARY UNIT.
WARNING: IF THE SPRINT/STROLLER/HI FLOW STROLLER DOES NOT SEPARATE EASILY, DO NOT USE FORCE. THE UNITS MAY BE FROZEN TOGETH­ER. LEAVE THE UNITS CONNECTED AND WAIT UNTIL THE UNITS WARM UP — THEN THEY WILL SEPARATE EASILY. DO NOT TOUCH ANY FROSTED PARTS. WARNING: SHOULD THE LEAKAGE BE EXCESSIVE TO THE POINT THAT A STREAM OF LIQUID IS PRESENT, LEAVE THE AREA AND CALL YOUR HEALTH CARE PROVIDER IMMEDIATELY.
WARNING: LIQUID OR COLD GASEOUS OXYGEN CAN FROSTBITE THE SKIN. OXYGEN WILL RESULT IN INCREASED FIRE HAZARD.
Caution: Should there be any liquid leak­age from the stationary unit or Sprint/ Stroller/Hi Flow Stroller separating the units, set the Sprint/Stroller/Hi Flow Stroller aside, ensuring it remains verti­cal, leave the room, and call your health care provider immediately.
PN MN236 A | User Manual 9 - ENG
Sprint / Stroller / Hi Flow Stroller
5. Use the following chart as a guideline to deter­mine the length of time the Sprint/Stroller/Hi Flow Stroller will operate:
FCV Setting
Model Sprint Stroller Hi Flow
Stroller
Nominal Nominal
FCV Pos.
Sprint Stroller Hi Flow
Stroller
Off 30:00 60:00 71:00
0.25 18:00 30:00 NA
0.5 12:12 23:00 32:00
0.75 9:18 17:24 NA
1 7:30 14:06 16:00
1.5 5:30 10:12 NA
2 4:18 8:00 8:00
2.5 3:36 6:36 6:20
3 3:06 5:36 5:20
4 2:24 4:24 4:00
5 2:00 3:36 NA
6 1:42 3:00 2:40
8 N/A 2:18 2:00
10 N/A 1:54 1:40
12 N/A 1:36 1:2-
15 N/A 1:24 1:00
Note: Times are in hours and minutes (format
00:00).
Note: The “Nominal” times are for ideal conditions,
i.e. maximum ll, exact ow rates, good loss
rate, unit not being moved, etc.
These times are the maximum expected.
Note: Your individual results will vary.
6a.To verify the level of liquid oxygen in the unit
with the electronic liquid level gauge:
Gen 3 Gauge: Depress the push button (liquid
level switch) on top of the unit for two seconds minimum. Read across the top of the light bar to indicate contents level.
Gen 4 Gauge: Press the green operate button on
the face of the gauge. Read the arc of LEDs, which indicates content level.
Caution:
The Sprint/Stroller/Hi Flow Stroller/Hi Flow Stroller is empty if only the last segment of the light bar is lit.
If the Low Battery indicator lights up when
the button is depressed, notify your health care provider.
NOTE: The Sprint/Stroller/Hi Flow Stroller/Hi Flow Stroller will continue to supply oxygen even if the Low Battery Indicator lights up, as long as there is liquid oxygen in the unit.
6b. To verify the level of liquid oxygen in unit with
the mechanical liquid level gauge:
Support the unit, by the fabric strap, directly
above the black contents indicator spring scale chamber.
Allow the unit to stabilize (i.e. not bounce up and
down), then read the exposed colored scale for approximate liquid oxygen contents.
10 - ENG PN MN236 A | User Manual
Sprint / Stroller / Hi Flow Stroller
NOTE: If the unit is empty, only the red colored band of the scale will be exposed. If this is the case, the unit must be filled prior to use.
7. Under certain environmental conditions, with continuous use, and especially with the portable not being moved, it may develop excessive frost around the vaporizer coil and on the case. You may reduce this frost by tapping the unit and/or wiping any accumulated frost off the case.
Condensate Pad Maintenance
After the unit is empty and has warmed up to room temperature, remove any moisture from the condensation cup:
For hard case
• Tilt the unit to one side. Grasp the knob at the center of the condensation cup (at the bottom of the unit) and pull straight out. This will release the cup.
NOTE: If heavily soiled, the pad can be machine washed (with bleach to disinfect).
• To replace the cup, center it over the round opening at the bottom of the unit and press the knob in one click to engage the cup and then a second click to lock the cup in place.
Knob Cup
NOTE: If the knob will not push in and engage the cup, hold the cup and pull the knob out until it clicks into the open position. Now replace the cup as previ­ously described.
For soft case
• Unzip the bottom zipper and pull back the bottom cover.
• Remove the pad from the cup and wring out any absorbed moisture. Allow the pad to dry completely before replacing it in the cup.
NOTE: If heavily soiled, the pad can be machine washed (with bleach to disinfect).
• To replace, simply insert pad into bottom cover and rezip the bottom zipper.
NOTE: If the knob will not push in and engage the cup, hold the cup and pull the knob out until it clicks into the open position. Now replace the cup as previ­ously described.
Frost Reduction
Under certain environmental conditions, with continuous use, and especially with the portable not being moved, it may develop excessive frost around the vaporizer coil and on the case. You may reduce this frost by tapping the unit and/or wiping any accumulated frost off the case.
WARNING: DUE TO THE POSSIBILITY OF EXCESSIVE MOISTURE / ICE BUILD UP IT IS RECOMMENDED THAT THE HI FLOW STROLLER REMAIN IDLE FOR 1 HOUR AFTER USE TO DECREASE MOISTURE BUILDUP.
Due to the higher ow rates associated with the Hi
Flow Stroller, condensation and some frosting will
occur on the unit, particularly on ow settings of
10 LPM and higher. It is recommended that the unit be allowed at least 1 hour of inactivity after use to decrease the possibility of excessive build up due to continuous usage.
PN MN236 A | User Manual 11 - ENG
Sprint / Stroller / Hi Flow Stroller
Troubleshooting
The following information is intended to help you troubleshoot and solve simple operational problems that you may experience when using your Sprint/Stroller/Hi Flow Stroller.
Issue Solution
The Portable makes a hissing sound.
• Hissing can occur to maintain the correct operating pressure within the Portable. It is most likely to hiss after filling or when the position of the Portable is changed. Hissing can last for approximately 10 minutes after filling. Additionally, it can occur when the flow control valve is at a low setting.
• If the portable has been laid in an improper position return the portable to an upright position and allow several minutes for the unit to stabilize
The Portable flow stops during use.
• Ensure that the cannula is firmly attached to the Oxygen Outlet.
• Ensure that the cannula is not kinked.
• Check the contents indicator/level gauge and fill the portable if needed.
• Ensure the flow control knob is not in the off (“0”) position.
The Portable does not fill. • Verify that there is oxygen in the Reservoir.
• Ensure that the Portable and Reservoir fill connectors are fully engaged through­out the filling process.
The Portable vent valve does not close properly at the end of the filling process.
• If the vent valve fails to close and the hissing sound and oxygen vapor cloud continue, carefully remove the Portable by depressing the release button on the Reservoir. Venting from the bottom of the Portable will stop in a few minutes. Allow the unit to warm until you can close the vent valve. The Portable may require as much as 60 minutes to restore adequate pressure for accurate oxygen flow. If needed, use an alternate source of oxygen such as a flow control valve attached to the Reservoir.
The Portable does not disengage easily from the Reservoir after filling.
• The Portable and Reservoir fill connectors may have become frozen.
• DO NOT USE FORCE. Allow a few minutes for the frozen parts to warm, then dis­engage the Portable when the ice has melted. To prevent the units from freezing together, always wipe the male fill connector on the Reservoir and the female fill connector on the Portable with a clean, dry cloth before filling.
12 - ENG PN MN236 A | User Manual
Sprint / Stroller / Hi Flow Stroller
Cleaning Standard
WARNING: CLEAN ONLY AFTER THE UNIT IS EMPTY.
• Clean using a solution of mild dish washing detergent and water.
• Apply cleaning solution directly to a lint-free cloth. Approved cleaners include HydroPure and HydroKlean. Do not spray cleaners di­rectly on the Sprint/Stroller/Hi Flow Stroller.
• Wipe the outside surface with the lint-free cloth until the outside surface is clean.
Caution: Do not use high temperature and high pressure washing equipment to clean these units.
• Do not get cleaner on any internal compo­nents or valves.
• Allow the unit to dry thoroughly before using.
Note: Note to health care provider – for reprocessing procedures, see applicable service manual.
WEEE and RoHS
This symbol is to remind the equipment owners to return it to a recycling facility at
the end of its life, per Waste Electrical and Electronic Equipment (WEEE) Directive. Our products will comply with the restriction of Hazardous Substances (RoHS) directive. They will not contain more than trace amounts of lead or other hazardous material content.
Disposal
Always return Sprint/Stroller/Hi Flow Stroller, in­cluding all components, to your homecare provider for proper disposal. You can also contact your
local city or town ofces for instructions on proper
disposal of the battery.
Transport and Storage
The device should be stored in the upright position, and be well ventilated. Do not allow the device to lie on its side. Humidity up to 95% noncondensing. Temperatures range from -40°F to 158°F (-40°C to 70°C).
Operating temperature ranges from 14°F to 104°F (-10°C to 40°C). Relative humidity range from 30% to 75% noncondensing.
Note: The atmospheric pressure range is 700 hPa to 1060 hPa (elevation of 10,000 Ft. to -1,000 Ft.).
Maintenance
Your service provider is responsible for any mainte­nance that my be required per the technical manual of this device. Call your service provider for any maintenance requirements.
The condensate pad is the only user-serviceable part. No other parts are user-serviceable.
The expected service life is a minimum of ve
years.
Clean the ll connectors on both the stationary
and portable units with a clean, dry, lint-free cloth
between each ll to prevent freezing and possible
equipment failure.
Note: Any additional maintenance needed must be done by a qualified service technician or service provider.
Accessories
Carrying Cart PN 20765565
PN MN236 A | User Manual 13 - ENG
Sprint / Stroller / Hi Flow Stroller
Safety
WARNING: PORTABLE RF COMMUNICATIONS EQUIPMENT (INCLUDING PERIPHERALS SUCH AS ANTENNA CABLES AND EXTERNAL ANTENNAS) SHOULD BE USED NO CLOSER THAN 30 CM (12 INCHES) TO ANY PART OF THE SPRINT/STROLLER/HI FLOW STROLLER, INCLUDING CABLES SPECIFIED BY THE MANUFACTURER. OTHERWISE, DEGRADATION OF THE PERFORMANCE OF THIS EQUIPMENT COULD RESULT.
WARNING: USE OF ACCESSORIES, TRANSDUCERS AND CABLES OTHER THAN THOSE SPECIFIED OR PROVIDED BY THE MANUFACTURER OF THIS EQUIPMENT COULD RESULT IN INCREASED ELECTROMAG­NETIC EMISSIONS OR DECREASED ELECTROMAGNETIC IMMUNITY OF THIS EQUIPMENT AND RESULT IN IMPROPER OPERATION.
WARNING: USE OF THIS EQUIPMENT ADJACENT TO OR STACKED WITH OTHER EQUIPMENT SHOULD BE AVOIDED BECAUSE IT COULD RESULT IN IMPROPER OPERATION. IF SUCH USE IS NECESSARY, THIS EQUIPMENT AND THE OTHER EQUIPMENT SHOULD BE OBSERVED TO VERIFY THAT THEY ARE OPERAT­ING NORMALLY.
Caution: Medical Electrical Equipment needs special precautions regarding Electromagnetic compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this manual.
Caution: Portable and mobile radio frequency (RF) communications equipment can affect Medical Electrical Equipment.
Table 1
Guidance and Manufacturer’s declaration—electromagnetic emissions
The Sprint/Stroller/Hi Flow Stroller is intended for use in the electromagnetic environment specified below. The customer or the user of the Sprint/Stroller/Hi Flow Stroller should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment—guidance
RF emissions Group 1 The Sprint/Stroller/Hi Flow Stroller uses RF energy only for internal function. CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. RF emissions CISPR 11 Class B Harmonic emissions The Sprint/Stroller/Hi Flow Stroller is suitable for use in all establishments, including IEC 61000-3-2 Not applicable domestic establishments and those directly connected to the Voltage fluctuations/ public low-voltage power supply network that supplies flicker emissions Not applicable buildings used for domestic purposes. IEC 61000-3-3
14 - ENG PN MN236 A | User Manual
Sprint / Stroller / Hi Flow Stroller
Table 2*
Recommended separation distances between portable and mobile
RF communications equipment and the Sprint/Stroller/Hi Flow Stroller
The Sprint/Stroller/Hi Flow Stroller is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Sprint/Stroller/Hi Flow Stroller can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Sprint/Stroller/Hi Flow Stroller as recom­mended below, according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to frequency of transmitter power of transmitter m
W 150 kHz to 80 MHz 80 MHz and 800 MHz 800 MHz to 2,5 GHz d=1.2P d=1.2 √P d=2.3 √P 0,01 0.12 m 0.12 m 0.23 m 0,1 0.38 m 0.38 m 0.73 m 1 1.2 m 1.2 m 2.3 m 10 3.8 m 3.8 m 7.3 m 100 12 m 12 m 23 m
For transmitters rated at a maximum output power not listed above, the recommended separation dis­tance (d) in meters (m) can be estimated using the equation applicable to the frequency of the transmit­ter, where P is the maximum output power rating of the transmitter in watts (W) according to the trans­mitter manufacturer. NOTE 1 at 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
* This table is included as a standard requirement for equipment which has been tested to specific test levels and over specific frequency ranges and been found compliant with regulations.
Table 3
Guidance and manufacturers declaration—electromagnetic immunity
The Sprint/Stroller/Hi Flow Stroller is intended for use in the electromagnetic environment specified below. The customer or the user of the Sprint/Stroller/Hi Flow Stroller should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment—guidance Electrostatic +- 8kV Contact +- 8kV Contact Floors should be wood, concrete or ceramic
discharge (ESD) +- 2 kV, +-4 kV, +- 2 kV, +-4 kV, tile. If floors are synthetic, the relative IEC 61000-4-2 +- 8 kV, +- 15 kV air +- 8 kV, +- 15 kV air humidity should be at least 30%.** Electrical fast ±2 kV for power Not applicable Not applicable transient/burst supply lines DC powered device IEC 610004-4 ±1 kV for Not applicable input/output lines No data input/output lines Surge ±1 kV line(s) to line(s) Not Applicable Not Applicable IEC 61000-4-5 ±2 kV line(s) to earth DC powered device
Voltage dips, <5% UT (>95% dip in UT) short interruptions for 0,5 cycle and voltage 40% UT (60% dip in UT) Not Applicable Not Applicable variations on for 5 cycles DC powered power supply 70% UT (30% dip in UT) device input lines for 25 cycles IEC 61000-4-11 <5% UT (>95% dip in UT) for 5 sec
Power frequency 30 A/m 30 A/m Power frequency magnetic fields should be (50/60 Hz) 50/60 Hz 50/60 Hz that of a typical commercial or hospital magnetic field environment. IEC 61000-4-8
Note: UT is the a.c. mains voltage prior to application of the test level.
** This statement indicates that the required testing was performed in a controlled environment and the Sprint/Stroller/Hi Flow Stroller are found to be compliant with regulations.
PN MN236 A | User Manual 15 - ENG
Sprint / Stroller / Hi Flow Stroller
Table 4
Guidance and Manufacturer’s Declaration—Immunity ME Equipment and ME Systems
Guidance and Manufacturer’s Declaration—Immunity
The Sprint/Stroller/Hi Flow Stroller is intended for use in the electromagnetic environment specied
below. The customer or user of the Sprint/Stroller/Hi Flow Stroller should ensure that it is used in such
an environment.
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment—Guidance
Conducted RF IEC
61000-4-6
Radiated RF IEC
61000-4-3
3 Vrms 6 Vrms (In ISM Bands) 150 kHz to 80 MHz
80 MHz to 2.7 GHz
Not applicable
Battery powered device, No SIP/SOP
10 V/m
80 MHz—2,7 GHz
80 % AM at 1 kHz
Portable and mobile RF communications equip­ment should be used no closer to any part of the Sprint/Stroller/Hi Flow Stroller, including cables, than the recommended separation dis­tance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance d = 1,2 P
d = 1,2 P d = 2,3 P where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recom­mended separation distance in meters (m).
Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency rangeb.
Interference may occur in the vicinity of equip­ment marked with the following symbol:
Test frequency
(MHz)
Band
a)
(MHz)
Service
a)
Modulation
b)
Maximum
power (W)
Distance
(m)
Immunity Test
Level (V/m)
385 380–390 TETRA 400
Pulse modulation
b)
18 Hz
1.8 0.3 27
450 430–470 GMRS 460, FRS 460
FM
C)
±5 kHz deviation
1 kHz sine
2 0.3 28
710
704–787 LTE Band 13, 17
Pulse modulation
b)
217 Hz
0.2 0.3 9745 780 810
800–960
GSM 800/900, TETRA
800, IDEN 820, CDMA
850, LTE Band 5
Pulse modulation
b)
18 Hz
2 0.3 28870
930
1720
1700–
1900
GSM 1800; CDMA 1900;
GSM 1900; DECT; LTE
Band 1, 3, 4, 25; UMTS
Pulse modulation
b)
217 Hz
2 0.3 281845
1970
2450
2400–
2570
Bluetooth, WLAN, 802.11
b/g/n, RFID 2450, LTE
Band 7
Pulse modulation
b)
217 Hz
2 0.3 28
5240
5100–
5800
WLAN 802.11 a/n
Pulse modulation
b)
217 Hz
0.2 0.3 95500
5785
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the Sprint/Stroller/Hi Flow Stroller may be reduced to 1m. The 1m test distance is permitted by IEC 61000-4-3.
a
For some services, only the uplink frequencies are included.
b
The carrier shall be modulated using a 50% duty cycle square wave signal.
c
As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it
would be worst case.
|MN236_A\~
MN236 A
Copyright © 2018 CAIRE Inc. CAIRE Inc. reserves the right to discontinue its
products, or change the prices, materials, equipment, quality, descriptions, specications and/
or, processes to its products at any time without prior notice and with no further obligation or consequence. All rights not expressly stated herein are reserved by us, as applicable.
www.cairemedical.com
CAIRE Inc. 2200 Airport Industrial Dr., Ste. 500 Ball Ground, GA 30107 U.S.A.
Medical Product Service GmbH Borngasse 20 35619 Braunfels, Germany
Medstar Importacaoe Exportacao Ltda Rua Valencio Soares Rodrigues, 89, Sala 01 Centro Vargem Grande Paulista/SP Brasil 06730-00 Tel/Fax: (55)(11)5535-0989 email: medstar@medstar.com.br
Loading...