QubiCell AUTO User Instruction Manual Ver 1

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mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.

CONTENTS

d) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

IMPORTANT SAFEGUARDS ...1 NOTE, CAUTION AND WARNING STATEMENTS: ...2 SYMBOLS ...2 1.

INTRODUCTION ...3

2.

PRODUCT DESCRIPTION ...4

3.

INSTALLATION ...8

4.

OPERATION...9

Recommended separation distances between portable and mobile RF communications equipment and this device: This device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of this device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and this device as recommended below, according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency of transmitter m power 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz of transmitter d  1.2 P d  1.2 P d  2.3 P W 0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

CLEANING ... 11

1

1.2

1.2

2.3

6.

STORAGE ... 11

10 100

3.8 12

3.8 12

7.3 23

7.

MAINTENANCE ...12

5.

8. EXPECTED SERVICE LIFE ...13 9. TROUBLE SHOOTING ...13

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.

10. TECHNICAL SPECIFICATIONS: ...14 APPENDIX A: EMC INFORMATION...15

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Guidance and Manufacturer’s Declaration - Electromagnetic Immunity:

IMPORTANT SAFEGUARDS

This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Immunity Test

IEC60601 test level

Compliance

READ ALL INSTRUCTIONS BEFORE USING

Electromagnetic Environment-Guidance Portable and mobile RF communications equipment should be used no closer to any part of this device, including cables, than there commended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d  1.2 P 150kHz to 80MHz

d  1.2 P 150kHz to 80MHz d  2.3 P 80 MHz to 2.5G MHz

DANGER - To reduce the risk of electrocution: 1. Always unplug this product immediately after using. 2. Do not use while bathing. 3. Do not place or store this product where it can fall or be pulled into a tub or sink. 4. Do not place in or drop into water or other liquid. 5. Do not reach for a product that has fallen into water. Unplug immediately.

WARNING -

To reduce the risk of burns, electrocution, fire, or injury to

persons: 1. Evaluate patients for entrapment risk according to protocol and monitor patients appropriately. 2. Use this product according to the manual and medical professionals’ instructions.

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3Vrms150 kHz to 80 MHz outside ISM bandsa

3 Vrms

3 V/m 80 MHz to 2.5 3 V/m GHz

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).b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey c, should be less than the compliance level in each frequency ranged. Interference may occur in the vicinity of equipment marked with the following symbol:

3. Close supervision is necessary when this product is used on or near children. Electrical burns or choking accident may result from a child swallowing a small part detached from the device. 4. Use this product only for its intended use as described in this manual. Do not use other mattress not recommended by the manufacturer. 5. Never operate this product if it has a damaged cord or plug, if it is not working properly, if it has been dropped or damaged, or dropped into water. Return the product to your supplier or Apex Medical Corp. for examination and repair. 6. Never block any air openings of this product or place it on soft surfaces, such as a bed or couch, where openings may be blocked. Keep the air opening free of lint, hair, and other similar particles. 7. Keep the cord away from heated surfaces. 8. Never drop or insert any object into any opening or hose. 9. Do not modify this equipment without authorization of the manufacturer. 10. Mattress covers have passed skin sensitization and skin irritation test. However, If you suspect

NOTE 1: At 80 MHz and 800 MHz, 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. a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz. b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.

that you may have had or are having an allergic reaction, please consult a physician immediately. 11. Do not leave long lengths of tubing around the top of your bed. It could lead to strangulation.

CAUTION – 1. If there is a possibility of electro-magnetic interference with mobile phones, please increase the distance (3.3m) between devices or turn off the mobile phone.

c) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land

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NOTE, CAUTION AND WARNING STATEMENTS: NOTE -

Appendix A: EMC Information

Guidance and Manufacturer’s Declaration- Electromagnetic Emissions:

Indicate some tips.

CAUTION - Indicate correct operating or maintenance procedures in order to prevent damage to or destruction of the equipment or other property WARNING - Calls attention to a potential danger that requires correct procedures or practices in order to prevent personal injury.

SYMBOLS Authorized representative in the European community. Manufacturer Protected against solid foreign objects of 1 mm and greater; Protection against vertically falling water drops

This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. Emissions Test RF emissions CISPR 11

Compliance Group1

RF emissions Class B CISPR 11 Harmonic emissions Class A IEC61000-3-2 Voltage fluctuations / Complies Flicker emissions IEC61000-3-3

Electromagnetic Environment-Guidance The device uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment

The device is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network

Guidance and Manufacturer’s Declaration- Electromagnetic Immunity: This device is intended for use in the electromagnetic environment specified below. The user of this device should make sure it is used in such an environment. IEC60601 test Electromagnetic Immunity Test Compliance level Environment-Guidance

Temeprature Limitation Consult operating instructions for use Class II Complies with standards protecting against electric shock for type BF equipment. Do Not Bleach Do Not Iron Tumble Dry, Normal, Low Heat Dry clean, Any Solvent Except Trichloroethylene Machine wash, regular / normal, 95 degrees C (203 degrees F) Attention – Observe proper Disposal of Electrical & Electronic Equipment (WEEE): This product should be handed over to an appropriate collection point for the recycling of electrical and electronic equipment. For more detailed information about the recycling of this product, please contact your local city office, household waste disposal service or the retail store where you purchased this product.

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Electrostatic Discharge (ESD) ±6kV contact IEC61000-4-2 ±8kV air

±6kV contact ±8kV air

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Electrical fast transient/ burst IEC61000-4-4

±2kV for power supply ±2kV for power supply Mains power quality should be that of atypical commercial or hospital line line ±1kV for input/out line ±1kV for input/out line environment

Surge IEC61000-4-5

± 1 kV line(s) to ± 1 kV line(s) to line(s) line(s) ± 2 kV line(s) to earth

Mains power quality should be that of atypical commercial or hospital environment.

<5 % UT (>95 % dip in <5 % UT (>95 % dip in Mains power quality should be that UT)for 0,5 cycle UT) for 0,5 cycle of atypical commercial or hospital Voltage dips, short 40 % UT (60 % dip in 40 % UT (60 % dip in environment. If the user of this interruptions and voltage UT)for 5 cycles UT) for 5 cycles device requires continued operation variations on power supply 70 % UT (30 % dip in 70 % UT (30 % dip in during power mains interruptions, it input lines UT)for 25 cycles UT) for 25 cycles is recommended that the device be IEC61000-4-11 <5 % UT (>95 % dip in <5 % UT (>95 % dip in powered from an uninterruptible UT)for 5 sec UT) for 5 sec power supply or a battery. Power frequency magnetic fields Power frequency should be at levels characteristic of atypical location in a typical (50/60Hz) magnetic field 3 A/m 3 A/m commercial or hospital IEC61000-4-8 environment. NOTE: UT is the a.c. mains voltage prior to the application of the test level

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10. TECHNICAL SPECIFICATIONS:

1.

Item Power Supply (Note: See rating label on the product)

Specification AC 220-240V 50 Hz, 0.07A (for 230V system)

Fuse Rating

T1AL, 250V

Cycle time

Four selectable

Dimension (L x W x H)

29.1 x 20 x 11.7 cm / 11.4" x 7.9" x 4.6"

Weight

2.2 Kg / 5 lb Operation: 10°C to 40°C (50°F to 104°F) Temperature

Storage: -15°C to 50°C (5°F to 122°F) Shipping: -15°C to 70°C (5°F to 158°F) Operation: 10% to 90% non-condensing

Environment

Humidity

Storage: 10% to 90% non-condensing Shipping: 10 % to 90% non-condensing

Atmospheric Pressure

Operation: 70 kPa to 101.3 kPa Storage: 70 kPa to 101.3 kPa Shipping: 70 kPa to 101.3 kPa Class II, Type BF, IP41 Not suitable for use in the presence of a flammable anesthetic mixture (No AP or APG protection)

Mattress

Specification

Model

5” (12.7 cm ) Overlay

8” (20.3 cm ) Replacement

200 x 90 x 12.7 cm /

200 x 90 x 20.3 cm /

78.7" x 35.4" x 5"

78.7" x 35.4" x 8"

Weight

5.6 Kg / 12.3 lb

7.1 Kg / 15.7 lb

Max. Support Weight

180 Kg / 396.8 lb

200 Kg / 440.9 lb

Dimension (L x W x H)

This manual should be used for initial set up of the system and for reference purposes.

1.1 General Information The system is a high quality and affordable mattress system suitable for treatment and prevention of pressure ulcers. The system has been tested and successfully approved to the following standards: EN 60601-1 EN 60601-1-2 EN 55011 Class B IEC61000-3-2 IEC 61000-3-3 EMC Warning Statement This equipment has been tested and found to comply with the limits for medical devices to the EN 60601-1-2:2007. These limits are designed to provide reasonable protection against harmful interference in a typical medical 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 other devices in the vicinity. However, there is no guarantee that

Applied Part: Air Mattress

Classification

INTRODUCTION

interference will not occur in a particular installation. If this equipment does cause harmful interference to other devices, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:  Reorient or relocate the receiving device.  Increase the separation between the equipment.  Connect the equipment into an outlet on a circuit different from that to which the other device(s) are connected.  Consult the manufacturer or field service technician for help.

1.2 Intended Use NOTE:

1. Consult the distributor or EU representative for further technical documents. 2. The specification is also suitable for other areas operating with same power supply. 3. Mattress dimension and weight is measured without foam cushion 4. The manufacturer reserves the right to modify the specification without notice.

This product is intended:  to help and reduce the incidence of pressure ulcers while optimizing patient comfort.  for long term home care of patients suffering from pressure ulcers.  for pain management as prescribed by a physician. The product can only be operated by personnels who are qualified to perform general nursing procedures and has received adequate training in knowledge of prevention and treatment of pressure ulcer. NOTE: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with oxygen or nitrous oxide. WARNING: Do not turn or flip patients who have fracture bone or spinal cord injury.

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2.

8. EXPECTED SERVICE LIFE

PRODUCT DESCRIPTION Unpack the box to check for any damage which may have occurred during shipment. If there are damages, please contact your dealer immediately.

The products are intended to offer safe and reliable operation when use or installed according to the instructions provided by Apex Medical. Apex Medical recommends that the system be inspected and serviced by authorized technicians if there are any signs of wear or concerns with device function and

2.1 Pump and Mattress System

indication on products. Otherwise, service and inspection of the devices generally should not be required.

1. CPR 2. Pump unit 3. Mattress System 4. Quick Connector

9. TROUBLE SHOOTING Problem

Power is not ON

Solution ‧ Check if the plug is connected to mains. ‧ Check for a blown fuse.

‧ Check if the power is suddenly shut down. Alarm is on (Audible & visual)

‧ Check if the CPR is sealed. ‧ Check if the connection between air tube connector to pump unit is tightly secured. ‧ Check if all tubing connections along mattress are secured.

2.2 Pump Unit Front 1. Quick Connectors 2. Front Panel

‧ Pressure setting might be inadequate for the patient. Adjust pressure Patient is bottoming out

level 1 to 2 levels higher and wait for a few minutes. Perform a hand check again to see if the problems were solved.

‧ Check if all the snap buttons or straps of mattress are all securely Mattress form is loose Rear 1. 2. 3. 4. 5.

fastened. ‧ Check if the mattress is fixed to the bed frame by straps.

Power Switch Power Cord Air Filter Fuses Mounting Brackets

No air produced from some air outlets of the air tube connector

4

‧ This is normal since there is alternating mode. Air outlets take turns to produce air during their cycle time.

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7.

2.3 Front panel

MAINTENANCE

7.1 General

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1. Check main power cord and plug if there is abrasions or excessive wear. 2. Check mattress cover for signs of wear or damage. Ensure mattress cover and tubes are stubbed together correctly. 3. Check airflow from the quick connector. The airflow should alternate between each connector every half-cycle time if it's in alternating mode. 4. Check the air hoses if there is kink or breaks. For replacement, please contact our local dealers.

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7.2 Fuse Replacement 1.

Disconnect the plug form mains power when a blown fuse is suspected.

2. Use a proper tool to remove the cover of the fuse holder.

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3. Insert a new fuse with a correct rating, and place

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the cover of the fuse holder back. The fuse should be rated as T1AL/250V type and VDE approved.

7.3 Air Filter Replacement 1. Use a proper tool to remove the cover of air filter place located at the back of pump. 2. Replace with a clean filter and put the cover lid back. 3. Check and replace air filter regularly if environment is dirty.

1. Pressure Adjust The function can automatically adjust the mattress pressure based on the patient’s weight. To remind user the process is on-going, the function LED lights will be periodically flashed from left to right until the Ready LED turn on permanently (the process is completed). There are three conditions will trigger this function to ensure the appropriate pressure setting for the patient. A. Press the Auto-Adjust button for 2 seconds, system will automatically re-adjust the pressure setting. B. The system will automatically start Auto-Adjust immediately after the initial mattress inflation is completed. C. While the system detects a significant change in patient’s weight on the mattress (e.g. patient Ingress) for a period of time, the system will automatically run the function again. NOTE: While the process is completed, system will return to previous setting automatically. To disable this function, press Auto-Adjust button again. NOTE: During the Auto-Adjust operation, it is normal that system will go through a series of inflation and deflation.

2. TUNING The Tuning function is to fine-tune the system auto-adjusted preset pressure. Three Tuning levels are available. “0” is system auto-adjusted preset pressure. “+” is one level higher than preset pressure, and “-” is one level lower than preset pressure. NOTE: The Tuning function is only available in alternate and static mode. 12

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5.

It is important to follow the cleaning procedures to avoid cross contamination. Be sure to clean the surface in a dry and dust free environment.Wipe down the pump unit with a damp cloth pre-soaked with a mild detergent. Avoid contact with dust and proximity to dusty areas. Make sure that any cleaning agents you use will not harm or corrode the plastic casing on the pump unit. If your doctor or medical facilities have other special cleaning instruction, please follow the professional instruction.

3. Modes The Therapy button allows you to choose one of the therapy modes. There are four selectable therapy modes available. Continually press Therapy button to select a desired mode: MaxFirm

Alternate

Static

Alternate+Seat Inflate

CLEANING

Static+Seat Inflate

CAUTION- Do not immerse or soak pump unit in liquids. WARNING: Do not remove the housing of the pump to avoid the electrical shock. All disassembly or repair should be done by professional techinicians.

NOTE: Every time the mattress is initialized (inflated), it will automatically go to "Max Firm" mode to hasten inflation. Once the system is ready to use, the system will go to alternate mode or your pre-set mode automatically.

CAUTION: The pump does not need oil lubrication, please do not disamble the system.

Cover

A. Max Firm The surface will go into Max firm automatically when the power switch is turned on. This insures the pump is able to reach its maximum operating pressure. Once the max pressure level is reached, the pump will automatically switch into alternating mode or preset setting. User can also use this function during patient transfers or nursing procedures for better support. This mode will last for 20 minutes and then it will return to previous mode automatically. To disable this function, press Maxfirm button again.

Stretch

Material:

+

Silver

Wipe-down the mattress unit with a damp cloth pre-soaked with warm water containing a mild detergent, or chlorine bleach followed by an approved intermediate level disinfectant. Also the mattress top cover can be completely removed for laundry with water temperature up to 95°C; however, it is recommended that the user still check with local policy to determine the time/ temperature ratio required to achieve thermal disinfection. The cover may also be cleaned using sodium hypochlorite diluted in water. After cleaning, please avoid dust and proximity to dusty areas and all parts should be air dried thoroughly before use.

NOTE: Max Firm and preset function LED will be illuminated simultaneously during initial mattress inflation until the mattress is reached to its maximum pressure.

CAUTION: Do not use phenolic based products for cleaning. B. Alternate Mode

CAUTION- After cleaning, dry the mattress without direct exposure of sunlight.

Continuously and sequentially inflate and deflate air cells to remove constant pressure and faciliatate improved cellular perfusion. C. Static Mode Provides a stable all cell inflated surface at lower pressure when compared to the respective comfort level in alternative mode. The system then redistribute patient weight over a greater surface; hence, for therapy to occur. The mode auto reverts after 20 minutes to the previous mode.

6.

STORAGE 1. Disconnect the quick connector. 2. Roll from the foot end towards the head end with CPR valve open, and make sure the tubing is not kinked. 3. Foot-end strap can then be stretched around the rolled mattress to prevent unrolling. Fasten the buckle strap to secure the packed mattress. NOTE: Do not kink, crease or stack the mattresses and do not store the system in direct sunlight, high temperature or moisture area.

D. Seat Inflation In case where patient needs to sit up or placed onto fowler’s position, this mode offers an additional increase in the pressure of the whole mattress, better supporting the sacral area. User can select this additional feature under either static or alternate mode. NOTE: Raising the Head-of-Bed no more than 30º to avoid excessive pressure on the sacral region.

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4.2 Pressure FINE-TUNE Depending on the desired preference, user can adjust mattress pressure slightly by pressing Tuning

button.

NOTE: Check to see if the suitable pressure is selected by sliding one hand between the deflated air cells and the patient to feel patient's buttocks. Users should be able to feel the minimum contact.

4.3 Emergency CPR Operations

4. Panel Lock If the control panel remains untouched for 5 minutes or manually press this button, a green LED will illuminate and the control panel will lock all settings. This will prevent the settings from being accidently changed during normal operation. To unlock, simply press the Panel lock button for 3 seconds.

5. Alarm Mute Press alarm mute button to temporary suspend the low-pressure alarm. If the situation did not resolve in 3 mins, the alarm will resume again to notify the caregiver.

When there is an emergency to perform CPR on the patient, quickly turn the CPR knob to release air from mattress. The CPR knob is located at the head-end, right-hand-side of the mattress. The quick connector on the pump unit can be disconnected for even faster deflation.

NOTE: When there is a power outage or a need of transporting the patient, one can capped on the quick connector as shown on the right to slow down the air leakage. Depending on that current setting, the mattress can remain inflated for 4~ 8 hours. If there is a bottom-out issue, please remove the patient from deflating mattress to another proper surface.

A. PFA (Power Failure Alarm) During power failure situation, both audio and visual PFA will on to notify carers to take appropriate action. By pressing the alarm mute button both PFA buzzer and LED will cease B. Low Pressure Indicator When the pressure is below setting pressure, the Low Pressure indicator (orange LED) will light up along with audio alarm. Please check if the CPR are correctly installed and if all connections are connected properly as per instructions. If the pressure level is consistently low, check for any leakage (tubes or connecting hoses). If necessary, replace any damaged tubes or hoses or contact local qualified dealer for repairment. NOTE: Even when pressing the Alarm Mute, the indicator light will stay on until the problem is solved. C. Tech. Support The Service indicator light will activate if an issue occurs with the system. User can notify the technician for repair.

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3.

4.

INSTALLATION NOTE: Unpack the box to inspect for any damage which may have occurred during shipment. If there are any damages, please contact your dealer immediately. 1.

Place the mattress or pad on top of a bed frame. There are securing straps on the base of the mattress. Secure the mattress firmly by fixing the straps to the bed frame, ensure that moving sections of the bed frame are still free to move. WARNING: The overlay mattress must be applied on the underlying mattress.

2.

3.

Hang the pump onto the footboard and adjust hangers so the pump is secured in an upright position; or place the pump on a flat surface.

Connect air hose connectors from air mattress to the pump unit. A “click” sound will be heard when connection is completed and secured. NOTE: Check and ensure the air hoses are not kinked or tucked under mattress.

4.

Plug the power cord into electrical outlet. CAUTION: Make sure the pump unit is suitable for the local power voltage. Also make sure that the mains power cable are positioned to avoid causing a trip or other hazard. Do not position the equipment so that it is difficult to operate the disconnecting device.

5.

Then turn the main power switch to ON position. CAUTION: The pump should only be used with the mattress recommended by the manufacturer. Do not use it for any other purpose.

Installation tips are listed below: The cable management loops are provided along the sides of the mattress to cover the mains power cable. Please make sure the wire has no signs of damage. After installation, the extra length of the power cord, if any, should be neatly managed to avoid causing a trip and should be clear of moving bed mechanisms or other possible entrapment area. The EQUIPMENT should be firmly placed at position where users/doctors can access easily.

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OPERATION NOTE: Always read the operating instruction before use.

4.1 General operation 1. Switch on the main power switch found on the side of the pump. 2. Every time when mattress is setup for use, It will be forced to execute Maxfirm mode for the quickest inflation. Once the pump begins delivering air into the mattress it will take approximately 30 minutes to fully inflate the mattress. NOTE: Please do not place patient on a mattress until it’s fully inflated. The user/ career can then adjust air mattress weight levels to the desired softness after set up has been completed. 3. The low-pressure (orange LED) audio and visual alarm will activate when the mattress is not fully inflated during initial inflation. If the appropriate pressure is reached, the low-pressure indicator (orange LED) will go off. NOTE: If the pressure level is consistently low for more than 40 minutes, check for any leakage (tubes or connecting hoses). If necessary, replace any damaged tubes or hoses or contact local qualified dealer for repair. 4. When the initial inflation (Maxfirm process) is completed, the system will automatically enter the Auto-Adjust process. 5. According to the weight and height of the patient, the system will automatically adjust an appropriate pressure setting to ensure the patient’s comfort, and then enter to alternating mode. .

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