Ultimate Healthcare UPRA3478D-2 Tamora II Digital Dynamic Mattress Overlay System User Manual

Ultimate Healthcare UPRA3478D-2 Tamora II Digital Dynamic Mattress

Overlay System

This User Manual contains instructions for the installation, use and maintenance of the Ultimate Healthcare Tamora II Digital dynamic mattress overlay system. You must read and fully understand this manual before using the system.

Caution

• Ultimate Healthcare shall not be liable for any damage or injury caused by failure to follow the proper instructions as described in this User Manual.
• Before using the dynamic mattress overlay system all staff must familiarise themselves thoroughly with the various parts and controls as detailed in this User Manual.

Note: Ultimate Healthcare reserves the right to modify the information in this User Manual at any time. The information in this User Manual may vary slightly with respect to the basic design of the product.

Intended Use

The intended use of this product is to prevent and/or manage pressure ulcers while optimising patient comfort for patients up to 200kg / 31.5 stone.

Contraindications

• The mattress is not suitable for use on patients with unstable fractures.

About the Product

The Tamora II Digital provides highly effective care and protection for patients at High to Very High Risk of pressure ulcer development and is suitable for use in a wide range of care settings from general ward and acute care to private or nursing home care. The Tamora II Digital is a lightweight, portable system with an intuitive digital control panel which allows accurate and appropriate pressure settings to be customised for various weight ranges. A clear LCD screen provides nursing staff with concise information on cycle time selections as well as the current operation status and fault conditions to ensure an efficient operation of the system. The Tamora II Digital offers key features for the delivery of high-quality pressure care to vulnerable patients. In addition to a 10-minute cycle the system offers variable cycle times with the choice of extended cycle periods of 15/20/25 and 30 minutes, which may be desirable as patients begin to rehabilitate and the risk reduces.

Mattress Overlay

Power Unit

Symbols and Statements

• Caution: Indicates correct operating or maintenance procedures in order to prevent damage to or destruction of the product or other property.
• Warning: Indicates potential danger that requires correct procedures or practices in order to prevent personal injury.
• BF symbol, indicates this product is according to degree of protection against electric shock for type BF equipment
• The operator must read this document (User Manual) before use.
• Water and dust protection classification.
• Disposal of electrical and electronic equipment (WEEE): This product should be handed over to an applicable collection point for the recycling of electrical and electronic equipment.
• CE certified.

Important Safety Information

• Please read all instructions prior to using any Ultimate Healthcare supplied product. The Tamora II Digital dynamic mattress overlay system must be used in accordance with this User Manual.
• The mattress must only be operated by personnel who have been properly trained or have suitable experience with products of this nature.
• Ensure a clinical Risk Assessment is conducted, which should take account of the suitability of use of this product, patient’s condition, any ancillary equipment in use and the surrounding environment. This should include assessing the use of side rails, head and footboards etc.
• Pressure settings should be advised or prescribed by a medical practitioner.
• Only personnel trained or formally approved by Ultimate Healthcare in operation and maintenance of Ultimate Healthcare products may perform maintenance, modification or repair work on any Ultimate Healthcare supplied product.
• Ensure the power cable is not trapped or twisted and is routed suitably to avoid crushing or entrapment when connected to the product.
• Do not use your mattress system power unit in the presence of flammable gases. This excludes oxygen cylinders.
• Avoid hazards caused by inappropriate handling of the power cable e.g., by kinking, shearing or other mechanical damages.
• The power cable for this product must be unplugged from the mains power outlet socket and suitably stowed before moving, cleaning or maintenance activities.
• Do not secure mattress straps to removable head or footboards or any fixed (non-moving) parts of a profiling bedframe.
• Disconnect from mains (power supply) before cleaning the power unit.
• When cleaning do not immerse the power unit in water.
• Use only the cleaning and disinfectant agents recommended in this User Manual.
• When connecting product after transportation or storage, inspect the power cable visually for any signs of damage. If evident, do not use product and contact Ultimate Healthcare or your local distributor for repair.
• When storing, ensure the product is stored away from direct sunlight and extreme cold conditions.
• Never block the air openings of this product or place it on a soft surface, such as a bed or couch, where their openings may be blocked. Keep the air opening free of lint, hair, and other similar particles. Air ventilation through the power unit is vital for correct and safe operation.
• If this product is used for any activity other than detailed within this User Manual, then personal risk to the end user or patient may occur. Ultimate Healthcare shall not be held liable/responsible for such an event.
• Do not smoke or allow the patient to smoke when using this product. Keep all possible ignition sources clear of this product. This includes E-cigarettes and lighters.

Technical Specification

Power unit

Mattress

Installation and Set-Up

Setting up mattress

For the comfort and safety of the patient do not put them onto the mattress overlay until you are sure that the mattress overlay is properly secured, and the system indicates that it is fully inflated. The mattress overlay is designed to be placed on an existing base mattress which may be in use on a bed. Place the mattress overlay on top of the base mattress, ensuring that the air pipe connector is situated on the bottom left-hand side of the bed foot end (as viewed from the foot of the bed). Secure the mattress overlay to the base mattress by utilising the elastic security straps fitted to the base cover of the mattress overlay. These elastic straps should be secured around the base mattress.

Caution

• Do not use the Tamora II Digital mattress overlay directly on the bed frame.
• Ensure when fixing the mattress overlay to the bed the security straps are only fitted to the moving parts of the mattress platform. Straps secured to the fixed parts of the mattress platform will damage the bed/mattress when operated.

Setting up power unit

Whilst holding the power unit, unfold the hanging hooks on the rear of the power unit and hang it from the bed’s footboard. If required, the power unit can be placed on the floor at the foot of the bed.

Caution: Ensure that the power cable is routed in such a manner so that it cannot be twisted, trapped, crushed or stressed.

Cable management system

Cable management fixings are located on each side of the mattress overlay underneath the flap of the cover. The mains power cable should be secured through the cable management fixing as follows:

• Locate each cable management fixing.
• If necessary, open the press studs.
• Run the mains power cable along the side of the mattress overlay securing each fixing loop around the cable using the press studs.

Connecting mattress to the power unit

• Remove the cover of the air pipe connector and connect the air pipe connector to the power unit and then ensure that the air tubes are free from any kind of obstruction and are not kinked.
• Plug the power cable into a suitable electrical socket and switch ‘ON’ using mains power switch found at the side of the power unit. All indicators on control panel will light up. The Standby indicator on the control panel will light up.
• Push the Operate button and the system will start inflation and the Auto-Firm indicator will flash.
• Once the mattress overlay is fully inflated, you can then set the mattress to the appropriate setting suitable for the patient. Please refer to Table 1 for the most suitable settings.

Caution: The power unit must only be connected to the mattress overlay recommended by the manufacturer. Do not use it for any other purpose.

Note: Ensure that the CPR valve is set to closed.

Table 1: Weight and Suggested Comfort Level Reference Table

Control Panel Operation Guide

• The Control Panel of the power unit is used to make adjustments to the mattress overlay and also indicates fault conditions/service requirements.
• These are either visual (indicator lights) or audible.
• When the incorrect button is pressed, a buzzer will sound to indicated that the pump is responsive.

Indicators
3| Comfort Setting Indicators| 8| Cycle Time Selection Button (Alternate)
4| Control Panel Lockout Button & Indicator| 9| Cycle Time Display
5| Function Mode Selection Button Alternate & Static| 10| Alarm Mute Button & Indicators

Operate / standby

• Press the Operate / Standby button to turn the power unit ON. Press again to turn OFF/Standby the power unit.

Note: The power switch on the side of the power unit must be turned ON.

Comfort level

• The Soft and Firm buttons allow carers to adjust pressures within a safe pre-set range to provide patients with enhanced comfort or support whilst maintaining a very good level of protection and therapy. Qualified clinical advice must always be taken before adjusting mattress pressures.
• The required pressure is selected using the Soft and Firm buttons to move the pressure by one step at a time.
• When pressing the Firm button, the output pressure will increase to provide a higher-pressure output and thus increased support.
• When pressing the soft button, the output pressure will be decreased to provider a lower pressure output and thus increased comfort.
• To check if the pressure is adequately supporting the patient, slide one hand between the mattress overlay and base mattress to feel under the patient’s bottom. You should be able to slide the hand in-between and an acceptable range is approximately 25 to 40 mm (1” to 1-1/2”) to ensure the patient Is not bottoming out.

Auto-detection

Simultaneously pressing the Soft and Firm buttons on the control panel will activate Auto-Detection. Once activated the indicator will flash and the system will start detecting and will set the internal pressure for the appropriately. The indicator light will flash until the patient’s weight and position has been detected then the light will extinguish. Auto-Detection sets the internal pressure for the patient so there is no requirement to input the patient’s weight, the internal pressure setting will vary slightly depending on BMI. For example, if you had two people weighting 65kg one tall and thin the other shorter and thicker set, the first patient may auto-detect to 50kg whilst the second to 75kg, this is due the difference in their BMI. The Auto- Detection will repeat every 2 hours to allow the system to adjust the pressure according to the patient’s position. To turn off the Auto-Detection simply press the Soft and Firm buttons again simultaneously.

Control panel lockout

If the control panel is not used for a period of 30 seconds it will lock out and inhibit the use of the functions. Additionally, if you wish to lock out the control panel press the Lock Out button, the button will flash, and all functions will be locked. This is to prevent the system being altered accidently. In order to unlock the control panel, simply press and hold the Lock Out button for 3 seconds, the control panel will now be active for use.

Function mode switch

Alternate

Alternating mode is the default mode for the system. Within this mode the mattress overlay will operate in an alternating 1-in-2 cell cycle. The alternating cycle will continue at the selected cycle time until another mode is selected.

Static

Pressing the Function Mode Selection button until the Static indicator illuminates puts the system into Static mode Within this mode the mattress overlay will maintain selected constant pressure. After 30 minutes the system will automatically revert back to Alternating mode.

Auto-Firm

Auto-Firm mode can be selected by pressing the Auto-Firm button. In this mode all cells inflate to a single pressure setting to provide a firm and stable surface for nursing procedures or for patient ingress/egress. The system will automatically return to Alternating mode at the previously selected comfort level after 20 minutes.

Alternate cycle time selection

The alternating cycle times can be selected to provide an individualized care program for each patient. Within Alternating mode, the cycle time can be selected by pressing the Cycle button. Selections can be made from 10-30 minutes at 5-minute intervals. The cycle time will be displayed in the LCD screen.

Alarm mute

The Alarm Mute button temporarily resets the audible Low Pressure/Power Failure/Service alarms. Should the situation not be resolved and the fault condition continues the alarm will resume notifying carer.

CPR Mode

CPR (Cardiopulmonary Resuscitation) can be performed using the red CPR valve which is situated at the head end on the left-hand side of the mattress. For rapid deflation gently pull and rotate the dial of the CPR valve to ‘click’ into the OPEN position. At the same time, disconnect the air pipe connector from the power unit to speed up the air release. If re-inflating the mattress, ensure the dial of the CPR attachment is rotated until it ‘clicks’ into the CLOSED position.

Transport Mode

If the patient is being moved on the mattress overlay, or there is a power cut, general pressure can be maintained in the system for an adequate period of time whilst disconnected from the mains. Simply disconnect air pipe connector and place the connector cover over it. The air pressures in the mattress overlay will remain as they were but will maintain a degree of comfort. This will maintain the cells in their present state for approximately 48 hours. It is important to restore the Tamora II dynamic overlay mattress as quickly as possible by reconnecting the supply tubes to the power unit.

Alarms & Fault Findings

The Tamora II Digital is equipped with audible and visual alarm indicators. These alert the user to the status of the available mains supply and any mattress defect.

Low pressure alarm

Upon detection of low pressure, an audible alarm will be heard and the Low- Pressure indicator will illuminate. The audible alarm may be cancelled by pressing the Alarm Mute button. The Low-Pressure indicator will continuously illuminate until the low pressure fault condition is resolved. This condition could be caused, for example, by incorrect fitting of the air pipe connector, opening of the CPR valve or a leak in the mattress due to a cut or puncture.

Power failure alarm

If at any time the mains power should be removed from the power unit or the power cable is unplugged without turning the power unit OFF, an audible alarm will be heard, and the Power Failure indicator will illuminate. The audible alarm may be cancelled by pressing the Alarm Mute button.

Note: When the power unit has not been used for more than 3 days, it might require 30 minutes operating time (or more) for the Alarm to function correctly.

Service (alternating failure alarm)

Should your system develop a fault condition whilst in use, an audible alarm will be heard, and the Service indicator will illuminate. The audible alarm may be cancelled by pressing the Alarm Mute button. Should the situation not be resolved, and the fault condition continues the alarm will resume. Please contact Ultimate Healthcare or your local service provider.

Annual Service Indicator

A dedicated Annual Service indicator on the control panel will illuminate and stay ON to alert nursing staff of the need for the system to be professionally serviced. The Annual Service indicator will illuminate after 365 days of use and the indicator light can only be extinguished by a professional service technician once the required service has been conducted.

Table 2: Alert/Error Code Reference Table

Priority High

↓ Low

| __

Warning Code

| __

Indicator LED

| __

Audible Output Mode

| __

Condition of Output

| __

Warning Description

| __

Remarks

---|---|---|---|---|---|---
0| N/A| N/A| ONCE| Not in System Shutdown| Key Tone| Key Tone from Functional Button
1| S.D| Power Failure| ONCE| Power-Off| System Shutdown| Shutdown
2| 8.8| ALL LED| ONCE| Operate or Standby| Power-On| All Indicators Light On
3| N/A| N/A| ONCE| Operate or Standby| State / Mode Switching| No Display
4| I.E| __

Auto-Firm

| __

ONCE

| __

Operate

| Mattress Inflation Completion| __

Inflation Ended

5| A.E| Auto-Firm| ONCE| Operate| Auto-Firm Completion| Auto-Firm Ended
6| S.E| Static| ONCE| Operate| Static Completion| Static Ended
7| N/A| Power Failure| REPEAT

(Cycle 4 sec.)

| Power-Off| Power Failure Alarm| No Display
8| I.F| Low Pressure| REPEAT

(Cycle 4 sec)

| Operate or Standby| Power-On Inflation Failure Alarm| Inflate Failure
9| A.F| Low Pressure| REPEAT

(Cycle 4 sec)

| Operate or Standby| Auto-Firm Failure Alarm| __

Auto-Firm Failure

10| l.p| Low Pressure| REPEAT

(Cycle 4 sec)

| Operate or Standby| Low Pressure Overtime Alarm| Low Pressure
11| h.p| __

Service

| REPEAT

(Cycle 4.5 sec)

| Operate or Standby| High Pressure Overtime Alarm| __

High Pressure

12| __| Service| REPEAT

(Cycle 4.5 sec)

| Operate or Standby| High Ambient Temperature Alarm| High Temperature
13| U.1| Service| REPEAT

(Cycle 4.5 sec)

| Operate or Standby| Air Valve 1 Positioning Failure Alarm| Air Valve 1 failure
14| U.2| Service| REPEAT

(Cycle 4.5 sec)

| Operate or Standby| Air Valve 2 Positioning Failure Alarm| Air Valve 2 failure
15| L.B| Service| REPEAT

(Cycle 15 sec)

| Operate or Standby| Battery Low Alarm| Battery would need to be replaced
__

16

| C.U| __

NONE

| __

NONE

| Factory Calibration Mode| __

Calibration Not Completed

| __

Calibration Unfinished

__

17

| C.C| __

NONE

| __

NONE

| Factory Calibration Mode| __

Calibration Completed

| __

Calibration Completed

Troubleshooting

No lights on power unit

|

• Check the power unit is connected to the mains power supply and that the mains switch is turned ON.
• Check power unit for any blown fuses.

Low Pressure indicator is flashing and sounding

|

• Check to ensure that the CPR tag is securely fitted in place.
• Check whether power was suddenly shut down.
• Check that the connection between air tube and power unit is tightly secured.
• Check that all tubing connections along the mattress are secured.
• If all of above steps have been checked. Press “Alarm Mute” for system to be verified again.

Power Failure Alarm Indicator is flashing and sounding|

• Check the power unit is connected to the mains power supply and that the mains switch is turned ON.

Patient is bottoming out (without alarm being triggered)

|

• Pressure setting might be inadequate for the patient, adjust comfort level to Firm and wait for a few minutes for a better comfort.

The power unit is operating but the mattress is not alternating

|

• Ensure that the mattress inflation process is complete.
• Check that the ‘Alternate’ indicator on the control panel is illuminated. If not, press Function Select Button to switch to Alternating mode.

Power unit is noisy

|

• Ensure that the power unit is resting against a solid surface.

• If the problem persists, contact Ultimate Healthcare or your local service provider.

Cleaning and Decontamination

The following processes are recommended but should be adapted to comply with the local or national guidelines (Decontamination of Medical Devices) which may apply within the Healthcare Facility of use. The Tamora II Digital system should be routinely decontaminated between patients and at regular intervals while in use as is good practice for all reusable medical devices.

• Warning: Disconnect the power unit from the electricity supply before carrying out cleaning/decontamination procedures.
• Do not immerse or soak power unit.

Basic cleaning information

Caution

• Only use disinfectants designed for cleaning healthcare equipment i.e., Sodium Hypochlorite or similar (up to 10,000 ppm available chlorine).
• Do not use abrasives (scouring powder), scourers or other materials/agents which could damage the mattress system.
• Do not use sodium carbonate or phenol-based solutions.
• Do not use fabric softener or biological washing detergents.
• Do not immerse the power unit in water.
• When cleaning/disinfecting, ensure that only a damp cloth is used.
• After cleaning, dry the mattress out of direct exposure to sunlight.
• Using inappropriate detergents or disinfectants and not observing the manufacturer’s guidelines may result in damage to the mattress which
• Ultimate Healthcare cannot be held liable for.
• The appropriate qualified staff must be consulted when specifying a suitable cleaning fluid. Ultimate Healthcare shall not be liable for any damages caused by the use of inappropriate detergents or disinfectants.

Mattress and cover disinfection

The Tamora II Digital mattress overlay, mattress cover and air pipe cover can be cleaned using the following simple procedures in accordance with your Local Infection Control Policy:

• Liberally swabbing with a damp cloth pre-soaked with hot water at 84°C containing detergent, and then drying.
• Swabbing with a solution of sodium hypochlorite (up to 10,000 parts per million available chlorine) and then drying.
• Caution: Frequent or prolonged exposure to higher concentration disinfectant solutions may prematurely age the fabric cover of mattresses. Surfaces must be protected during use and rinsed and thoroughly dried after application of a disinfectant.

Power unit disinfection

The power unit can be cleaned by wiping down with a cloth dampened with hot water at 600C containing detergent or with sodium hypochlorite (up to 10,000 parts per million available chlorine).

Cover laundering

The mattress cover and air pipe cover can also be machine washed. Mattress covers and air pipe cover should be completely removed prior to laundering. Where required mattress covers can be laundered in a pre-wash at 600C for up to 15 minutes and in a main wash at 840C for up to 15 minutes. This should be followed by a cold rinse and extraction. However it is recommended that you check your local policy to determine the time/temperature ratio required to achieve thermal disinfection. Mattress covers may be tumble dried or air dried. They may be tumble dried on a low heat for up to 90 minutes. Drying temperature must not exceed 400C. The mattress cover and mattress must be dry prior to refitting.

• Caution: Exceeding the temperature can cause significant damage to the mattress cover.

Storage

The mattress overlay should be loosely rolled lengthwise with the cover innermost, taking care not to strain the air pipe. It should then be placed in in a suitable protective cover with the power unit and stored in an area appropriate for electronic medical devices.

• To quickly extract air out from mattress for storage, pull the CPR tag to remove the CPR plugs and disconnect the air hose connector to release the air.
• Lay the mattress out flat.
• Roll from the head end towards the foot end.
• The foot end strap can then be stretched around the rolled mattress to prevent unrolling.
• The power cord could be wrapped around the power unit bumper or disconnected for storage.
• Caution: Do not fold, crease or stack mattresses.

Service and Maintenance

It is recommended that this product be part of a routine preventative maintenance schedule with a planned service every 12 months regardless of product usage.

General

1. Check power cable and plug if there are abrasions or excessive wears.
2. Check mattress cover for signs of wear or damage. Ensure mattress cover and tubes are stubbed together correctly.
3. Check the air hoses for any kink or break. For replacement, please contact Ultimate Healthcare or your local distributor.

Fuse replacement

1. Disconnect the plug from mains power when a blown fuse is suspected.
2. Remove the cover of the fuse holder by means of a small screwdriver.
3. Insert a new fuse of the correct rating in and replace the cover of the fuse holder back. The fuse should be rated as T1A.

Air filter replacement

1. Replace the air filter located at the handle on the back of the power unit.
2. The filter is reusable and can be washed gently with a mild detergent and water. Dry the filter before use.
3. Check and replace air filter regularly if environment is dirty.

EMC Information

Manufacturer’s declaration-electromagnetic emissions

The device(s) is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.

The customer or the user of the device(s) should assure that it is used in such an environment.

Emission test| Compliance| Electromagnetic environment guidance (for home and professional healthcare environment)
RF emissions CISPR 11| Group 1| The device(s) 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.
RF emissions CISPR 11| Class B| The device(s) is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations

/flicker emissions IEC 61000-3-3

| ****

Compliance

Manufacturer’s declaration-electromagnetic immunity

The device(s) is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the device(s) should assure that it is used in such an environment.

Immunity test| IEC 60601

test level

| Compliance level| Electromagnetic environment- guidance (for home and professional healthcare environment)
Electrostatic discharge(ESD) IEC 61000-4-2| Contact:±8 kV

Air±2 kV,±4 kV,±8 kV,±15 kV

| Contact:±8 kV

Air±2 kV,±4 kV,±8 kV,±15 kV

| 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

IEC 61000-4-4

| + 2kV for power supply lines

+ 1kV for input/output lines

| + 2kV for power supply lines Not applicable| Mains power quality should be that of a typical home and professional

healthcare environment.

Surge

IEC 61000-4-5

| + 0.5kV, + 1kV line(s) to line(s)

+ 0.5kV, + 1kV, + 2kV line(s) to earth

| + 0.5kV, + 1kV line(s) to line(s) Not applicable| Mains power quality should be that of a

typical home and professional healthcare environment.

Voltage Dips, short interruptions and voltage variations on power supply input lines

IEC 61000-4-11

| Voltage dips:

0 % U T; 0,5 cycle

0 % U T; 1 cycle

70 % U T; 25/30 cycles

Voltage interruptions: 0 % U T; 250/300 cycle

| Voltage dips:

0 % U T; 0,5 cycle

0 % U T; 1 cycle

70 % U T; 25 cycles

Voltage interruptions: 0 % U T; 250 cycle

| Mains power quality should be that of a typical home and professional healthcare environment. If the user of the device(s) requires continued operation during power mains interruptions, it is recommended that the device(s) be powered from an uninterruptible power supply or a battery.
Power frequency(50, 60 Hz) magnetic field

IEC 61000-4-8

| 30 A/m

50 Hz or 60 Hz

| 30 A/m

50 Hz

| The device(s) power frequency magnetic fields should be at levels characteristic of a typical location in a typical home and professional healthcare

environment.

NOTE: UT is the a.c. mains voltage prior to application of the test level.

Manufacturer’s declaration-electromagnetic immunity

The device(s) is intended for use in the electromagnetic environment (for home and professional healthcare) specified below.

The customer or the user of the device(s) should assure that it is used in such an environment.

Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment guidance **(for home and professional healthcare**

environment)

Conducted RF| 3 Vrms:| 3 Vrms:| Portable and mobile RF communications
IEC 61000-4-6| 0,15 MHz – 80 MHz| 0,15 MHz – 80 MHz| equipment should be used no closer to any
 | 6 Vrms:| 6 Vrms:| part of the device(s) including cables, than the
 | in ISM and amateur| in ISM and amateur| recommended separation distance calculated
 | radio bands between| radio bands between| from the equation applicable to the frequency of
 | 0,15 MHz and 80 MHz| 0,15 MHz and 80 MHz| the transmitter.
 | 80 % AM at 1 kHz| 80 % AM at 1 kHz|
Radiated RF| 10 V/m| 10 V/m| Recommended separation distance:
IEC 61000-4-3| 80 MHz – 2,7 GHz| 80 MHz – 2,7 GHz| d = 1,2 √ P
 | 80 % AM at 1 kHz| 80 % AM at 1 kHz| d = 1,2 √ P 80MHz to 800 MHz d = 2,3 √ P 800MHz to 2,7 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 metres (m).
 |  |  | ****

Interference may occur in the vicinity of

 |  |  | equipment marked with the following symbol:
 |  |  |
NOTE1: At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

The recommended separation distance between portable and mobile RF communications equipment and the device(s)

The device(s) is intended for use in an electromagnetic environment (for home and professional healthcare) in which radiated RF disturbances are controlled. The customer or the user of the device(s) can help prevent electromagnetic interference by maintaining a minimum distance between portable and

mobile RF communications equipment (transmitters) and the device(s) as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of transmitter| Separation distance according to frequency of transmitter

m

150 kHz to 80 MHz| 80 MHz to 800 MHz| 800 MHz to 2,7 GHz
W| d =1,2 √ P| d =1,2 √ P| d =2,3 √ P
0,01| 0,12| 0,12| 0,23
0,1| 0,38| 0,38| 0,73
1| 1,2| 1,2| 2,3
10| 3,8| 3,8| 7,3
100| 12| 12| 23
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.

NOTE1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Manufacturer’s declaration-electromagnetic immunity

**Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment**

The device(s) is intended for use in the electromagnetic environment (for home and professional healthcare) specified below. The customer or the user of the device(s) should assure that it is used in such an environment.

|
---|---

Test frequency (MHz)

| ****

Band a)

(MHz)

| ****

Service a)

| ****

Modulation b)

| ****

Maximum power (W)

| ****

Distance

(m)

| ****

IMMUNITY TEST LEVEL

(V/m)

| Compliance LEVEL

(V/m)

(for home and professional healthcare)

|

385

| ****

380 –390

| ****

TETRA 400

| Pulse modulation b) 18 Hz| ****

1,8

| ****

0,3

| ****

27

| ****

27

|

450

| ****

430 – 470

| ****

GMRS 460,

FRS 460

| FM c)

±5 kHz deviation

1 kHz sine

| ****

2

| ****

0,3

| ****

28

| ****

28

|
710| ****

704 – 787

| ****

LTE Band 13,

17

| ****

Pulse modulation b) 217 Hz

| ****

0,2

| ****

0,3

| ****

9

| ****

9

|
745|
780|
810|  | GSM|  |  |  |  |  |

800 – 960

| 800/900, TETRA

800,

iDEN 820,

| Pulse modulation b) 18 Hz| ****

2

| ****

0,3

| ****

28

| ****

28

|
870|
930|
 | CDMA 850,|  |  |  |  |  |
 | LTE Band 5|  |  |  |  |  |
1 720|  | GSM 1800;

CDMA 1900; GSM 1900; DECT;

LTE Band 1,

3,

| ****

Pulse modulation b) 217 Hz

| ****

2

| ****

0,3

| ****

28

| ****

28

|

1 845

| 1 700 –|
1 990|
1 970|  |

2 450

| ****

2 400 –

2 570

| ****

Bluetooth, WLAN,

802.11 b/g/n, RFID 2450, LTE Band 7

| ****

Pulse modulation b) 217 Hz

| ****

2

| ****

0,3

| ****

28

| ****

28

|
5 240| ****

5 100 –

| ****

WLAN 802.11

| ****

Pulse modulation b) 217 Hz

| ****

0,2

| ****

0,3

| ****

9

| ****

9

|
5 500|
5 800| a/n|
5 785|
NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the

ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

|

•  For some services, only the uplink frequencies are included.
• The carrier shall be modulated using a 50 % duty cycle square wave signal.
• 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.

|

Ultimate Healthcare Ltd

• Calmore Industrial Estate, Nutwood Way, Totton Southampton, Hampshire, SO40 3WW
• Tel: 0333 321 8996
• Fax: 023 8066 2388
• Email: info@ultimatehealthcare.co.uk
• www.ultimatehealthcare.co.uk

References

• Ultimate Healthcare - Ultimate Healthcare

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