Red-Eye Intravenous Drip Monitor SW 8. 02L User Manual Issue 3

1: Introduction. In this manual you will find instructions on how to operate the Red-Eye Ô Intravenous Drip Monitor safely and correctly, how to care for it and what to do should anything go wrong. Please take the time to read all the information before you use the Drip Monitor and follow any warnings printed in bold type. The Drip Monitor is a medical device and has been carefully designed and made to achieve a high level of safety protection. In making a decision when to use the Red-EyeÔ Drip Monitor the performance specification should be considered along with the treatment being applied. Please ensure that this Instruction Manual is given to the person who will be responsible for using the Drip Monitor before using the equipment.

What is the Red-Eye Ô Intravenous Drip Monitor The Red-Eye™ Intravenous Drip Monitor is a battery operated monitor which displays and records the flow of fluid from a gravity-feed intravenous drip bag via an administration set. It is suitable for monitoring blood, blood products, antibiotics and saline or dextrose based fluids. The Drip Monitor can also be programmed in advance to remain in use throughout a series of infusions. A printed record can be retained for patient records.

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Functions of Red-Eye™ Constant monitoring: The Drip Monitor displays and records the following for each patient: Ø Ø Ø Ø

Rate of flow in millilitres per hour Total fluid delivered (in millilitres) Time and date Patient ID Number

Early warning: The Drip Monitor provides an early warning in the form of a red light and an optional audible alarm when: Ø Ø Ø Ø

The flow deviates from the pre-set rate The required volume of fluid has been delivered by infusion. The fluid bag becomes empty. The flow is interrupted for some other reason, e.g. the venflon has tissued

Automatic patient records: Recorded data of each IV infusion can be downloaded easily to a computer (PC) to complete the patient records. Simple to operate: Monitoring of the IV drips is by optical means. The Drip Monitor calculates fluid flow (ml/h) without the need to use complicated, time-consuming formulae. Keypads are “membrane type” to prevent fluids infiltrating into the equipment and they have a touch sensitive feel for confident operation.

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2: How to use the Drip Monitor. Do’s and Do Nots DO DO

DO NOT DO NOT

DO NOT DO NOT

DO NOT

check the battery daily (the icon is updated on the screen every 15 seconds). recharge overnight once finished using the device. use this device without understanding these instructions. get the Drip Monitor wet. It is not waterproof and the performance will be affected. open the Drip Monitor casing to look inside. The performance will be affected. use it outside the Drip Monitor’s temperature range. The performance will be affected. bend the sensor lead into an acute angle. The performance will be affected.

Charging the Batteries. The batteries are nickel metal hydride cells. The battery icon on the front screen shows the condition of the batteries. The charger supplied with the device will recharge to full power in 5 hours. Once fully charged the device should last 3 to 4 days of constant use. To charge using the battery charger supplied, plug the charger into the top socket on the left side of the docking station. (See item 10 Page 5) Turn on the charger at the electric socket.

WARNING: The Drip Monitor will not run while charging. Do not plug the charger into the docking station while the Drip Monitor is in use. The Drip Monitor will alarm when the battery level becomes low and requires charging. The alarm is a tone pulse every 30 seconds.

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Getting to know the Indicators, Buttons and Connections Red-Eye™ Display Unit

• † ƒ

‚

„

• Display screen ‚ Top row keys - function keys ƒ Arrow keys to change values „ Green (OK) indicator ‡ … Red alarm indicator † Power On/Off button „ ⑦ Giving Set Chamber Clip …

Docking station

⑧ Sensor-lead socket

⑧

⑨ Pole clamp bracket ⑩ Charger socket ⑪ Bag light alarm socket

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⑨

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⑩

⑪

What the Symbols on the Device Mean.

An electrical safety classification in the international safety standard for medical electrical equipment, type BF. If the equipment is used as intended there is no risk of a serious electric shock, but it is not suitable for direct connection to the heart.

Refer to the accompanying instructions on how to use the equipment. The instructions are all in this manual.

The CE mark demonstrates that the Drip Monitor conforms to the requirements in the European Council Directive 93/42/EEC concerning medical devices. The number 0123 identifies the Notified Body under which the Quality Systems operated within Zimed Ltd are assessed.

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Setting Up The Drip Monitor. The Drip Monitor is a battery operated device. It must be charged initially, via the mains battery charger, for 5 hours to ensure maximum operation of the internal battery. (See Charging the Batteries page 5) The time and date must be set before using the device. Once charged, the internal battery will operate for up to 72 hours. Only use the RedEye™ charger supplied.

1. Attach docking station to drip stand using the pole clamp. Use the thumbscrew to secure.

2. Clip display unit onto the docking station. 3. Insert sensor clip lead into socket on the docking station.

•

4. Attach sensor clip to giving set chamber and clip to side. ƒ

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‚

Setting The Drip Monitor. To Switch “ON” Press the Blue Button SOLUTION, BLOOD, OR MENU. v 20 DROPS =1mL SOLUTION,

15 DROPS =1mL BLOOD, OPTIONS =

Parameters of the Monitor

This is the first screen that appears when the Monitor is turned on. You must select either “Solution” or “Blood” to set a desired flow rate: To change any parameters of the monitor select the “Menu” button. This will allow you to change different setting in the monitor.

“First Screen” GIVING SET SELECT SOLUTION BLOOD

MENU

Press “MENU” to change any of the settings on these screens (See page 9) TO SET YOUR DESIRED FLOW RATE IN ml per hour YOU SET THE FLOW RATE USING THE ROLLER CLAMP AS NORMAL THIS SCREEN DISPLAYS THE FLOW RATE IN ml per hour. ONCE THE SCREEN DISPLAYS YOUR DESIRED RATE PRESS “START”. THE VALUE ON THIS SCREEN IS SAVED AS YOUR “SET RATE”. PRESS THE “OFF” BUTTON IF YOU NEED TO RETURN TO THE START.

Pressing the New infusion button resets the V.T.B.I (Volume to be infused); pressing the cont infusion button continues the V.T.B.I counter.

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SET ROLLER CLAMP

0000 ml / h OFF

START

Parameters of the Monitor. 1-TOTAL VOLUME TO BE INFUSED. v Required if giving multiple bags or small amounts less than one full bag v If only giving full single bags ignore v To change this screen press: the “menu” button once. “MENU” v To change the flashing digit press the up or down arrow until the digit is correct. Press the Þ button to move the flashing digit to the next digit along. 2-ALARM RANGE v See Graph below, show’s the amount the I-V can deviate before an alarm is given v To change this screen press: the “menu” button once and then the “next” button once “MENU”-“NEXT” v To change use the up and down arrows (Min value 10%-Max 90%) 3-ALARM DELAY v Equals the length of time the “Actual Rate” is out of range before it will alarm v Once set to a value this generally does not need to be changed. v To change this screen press:: the “menu” button once and then the “next” button twice “MENU”-“NEXT” “NEXT” v To change use the up and down arrows (Min value 10 seconds - Max 90seconds) 4-PATIENT IDENTIFICATION. v Required if Data logging, if not logging then ignore v To change this screen to the correct Patient Id, press the “menu” button from the first screen that appears when the monitor is turned ON, then the “NEXT” button 3 times “MENU” “NEXT””NEXT””NEXT”” v To change the flashing digit press the up or down arrow until the digit is correct. Press the Þ button to move the flashing digit to the next digit along.

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Monitor is now “SET” THIS SCREEN DISPLAYS THE “SET RATE” (TOP OF SCREEN) AND THE “ACTUAL RATE” (CENTRE OF SCREEN) THE CURRENT I-V RATE IF THE “ACTUAL RATE” (CENTRE OF SCREEN) FALLS OUTSIDE ITS ALARM RANGE THE BLACK BELL SYMBOL WILL BE SHOWN.

SET RATE 000

0000 ml/h MUTE HOME VOL

IF THE BELL SHOWS FOR LONGER THAN THE SET ALARM DELAY TIME THE DRIP MONITOR WILL ALARM (See Alarms below)

“Mute” TO “MUTE” THE ALARM PRESS THE BLUE KEY. THE ALARM WILL BE MUTED FOR 3 MINUTES TO GIVE TIME FOR ANY CHANGES TO BE MADE ALLOWING THE “ACTUAL RATE”” TO BE BROUGHT TO WITHIN RANGE OF THE “SET RATE”.

DISPLAYS THE TOTAL VOLUME INFUSED, THIS SCREEN RETURNS TO THE PREVIOUS SCREEN AUTOMATICALY

“OFF” TO SWITCH OFF THE DRIP MONITOR – PRESS THE “HOME” BUTTON THEN THE WORD OFF APPEARS ON THE LEFT OF THE SCREEN. PRESS AND HOLD UNTIL THE SCREEN TURNS OFF.

Alarms The main alarm is an audible tone pulsed every 10 seconds. If the flow rate deviates to outside the alarm range, preset by the operator, (See “Parameters of the Drip Monitor”), the green light on the front of the monitor will go out and the red light will illuminate. The display also reverses from mainly white to mainly black. For night time use the audible alarm can be turned off and the bag light plugged in to the docking station (see Getting To Know the Indicators, Buttons and Connections on page 5). The bag light is clipped on to the corner tab of the bags of fluid.

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Device Set Contents / Accessories.

The Red Eye Intravenous Drip Monitor Device Set comprises of:

Quantity

Description

Part Number

1

Display Unit

Z-3-009/B

1

Docking Station

Z-3-008/A

1

Sensor Lead

Z-6-001/C

1

Mains power charger

Z-3-014/B

1

Operating manual

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Bag light

Z-7-001/A

Optional Extras

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PC software

Part Number on Request

PC Data download lead

Part Number on Request

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3: Care and Maintenance. When used as described in these instructions the Monitor does not require any routine maintenance apart from the occasional cleaning. It is recommended that the performance of the monitor is checked annually. If the monitor is damaged in any way the performance must always be checked before it is used again. See Servicing on page 13 for further information.

Cleaning. The outside surfaces can be cleaned by wiping with a soft cloth either dampened with a solution of mild detergent or disinfectant, in water. Cleaning with organic solvents, e.g. surgical spirit, or abrasive cleaners, may damage some of the plastic parts. WARNING: Risk of change in device performance. Never dip or immerse the Drip Monitor in any liquid or try to sterilize it with steam or gas. It is not completely sealed.

Storage. If you are going to store the Drip Monitor for some time, isolate the battery by inserting a paper clip type probe into the hole on the back of the display unit and press the switch in the hole to turn it off. Store in warm dry place. When you are ready to start to use the Drip Monitor, repeat the same process as above and then turn on the Drip Monitor to check the status of the battery, charge if necessary before use.

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Servicing. Either the Zi-Medical service department must repair the Drip Monitor, or one of its appointed representatives, or an appropriately trained technician who has access to the correct technical manuals, service bulletins and approved replacement parts. WARNING: Risk of change in device performance. Always use the appropriate parts and procedures for repair and testing as advised by Zi-Medical and published in its literature.

For after-sales service or advice on how to use the Monitor you can contact customer services either by telephone, email or by letter, the details are to be found on back-cover of this manual. Please have the serial number to hand when you call, which is found on the label on the reverse of all the units: Display, Docking, and Charger units.

Disposal. When the time comes to dispose of the Monitor, accessories or packaging do so in the best way to minimise any negative impact on the environment. You may be able to use special recycling or disposal schemes. To find out about these contact your local waste disposal service. Separate any parts of the equipment where arrangements can be made for their recovery, either by recycling or energy recovery. Important: existing national or local regulations concerning waste disposal must take precedence over the above advice.

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What’s the problem? If the Drip Monitor does not perform as expected, if it is dropped, gets wet or is damaged in any way, then remove it from use immediately. Label it clearly as quarantined and preferably take it out of the working area, to ensure it cannot be used accidentally until it has been checked. The Drip Monitor must be carefully inspected for damage inside and its performance checked to the specification. A properly trained technician must complete these tests. WARNING: Risk of change in device performance. If the Drip Monitor gets wet do not just dry the outside and then continue to use - liquid may be inside and could have caused damage. Follow the advice given above

Helpful Hints. 1 Re charge overnight. 2 When clamped on drip stand, try to angle back to enable clear view of screen. 3 Fit drip sensor clip about 1 to 2mm from the top of the giving set. 4 Ensure that the giving set is vertical. 5 If not vertical, rotate the sensor clip until drip detection is made in the giving set screen.

Monitor stopped working. A If the Sensor Fault message appears on starting the Drip Monitor check the following: Is the sensor lead connected?/Plugged in to the socket correctly? Is the sensor too low on the giving set and the beam below the water level? Is the sensor too high and the beam being broken by the giving set pipette? Is there condensation or any splashes in the giving set chamber? Is the Drip Monitor in very bright daylight? Is the battery low in the Drip Monitor? B If the green light is not flashing when using roller clamp screen, see points 2 to 4 above. C If the green light ceases to “blink” when the drip passes the sensor, ensure the clip position is such that the beam is broken by the drip.

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4: A Guide to Suitable Applications. The Red-Eye™ IV Drip Monitor is intended to be used in combination with an intravenous drip, i.e. .an administration set and an IV fluid bag. Intravenous drips are used to deliver blood, blood products, antibiotics, and saline or dextrose based products.

The Drip Monitor functions by calculating flow rate (ml per hour), via a fibre optic cable connected to a flexi-clip fitted to the administration set of the IV apparatus.

There are two broad categories of administration sets, which the Drip Monitor is compatible for use with: v Blood Administration sets: - calibrated to deliver 15 drops per ml of blood. v Solution Administration sets: - calibrated to deliver 20 drops per ml of H2O. These sets are suitable for all saline/dextrose-based products.

MINIMUM DIAMETER:

17 mm

of administration set

MAXIMUM DIAMETER:

24 mm

of administration set

MINIMUM DIAMETER:

12 mm

of drip stand

MAXIMUM DIAMETER:

30 mm

of drip stand

Please refer to the individual manufacturer of administration sets for advice regarding administration of drugs / fluids not easily categorised into blood or saline type fluid. Z-9-002/M

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5: Technical and Performance Specification. Administration set 15 or 20 drops/ml Measurement range 10 to 1000 ml/hour Alarm range 10 to 90% in steps of 10% Alarm delay 10 seconds to 90 seconds in steps of 10 seconds Mute delay 3 minutes Pre-set volume to infuse 0 to 9999 ml in steps of 1 ml Total measurement 9999 ml manually re-set Accuracy: ±20% (H2O at room temperature) Operating time At least 72 hours continuous from full charge Recharge time 5 hours maximum Time Displayed continually when in use Date and time

Recorded at start of administration Z-9-002/M

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6: Addendum, Electromagnetic Compatability This addendum to the Red Eye ™ User Manual provides information required by EN60601-1-2:2001. It describes the Standards to which the Red Eye ™ was tested and approved, the minimum test level identified in the Standard, and general guidance on management of the EMC environment in which the Red Eye ™ may be safely used. Precautions should be taken to avoid exposing the Red Eye ™ to powerful sources of electromagnetic radiation such as MRI (magnetic resonance imaging) and ESU (electrosurgical equipment). Note also that portable and mobile communications equipment such as cell phones can adversely affect medical electrical equipment. The Red Eye ™ drip monitor is intended to be used in conjunction with other equipment, forming a “system”. Correct operation of all elements of the “system” must be verified before use.

Table 1: Guidance and Manufacturers Declaration - Electromagnetic Emissions The drip monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the drip monitor should assure that it is used in such an environment.

Emission Test

Compliance

Electromagnetic environment - Guidance

RF emissions CISPR 11

Group 1

The drip monitor uses RF energy only for its internal function. Therefore, its emissions are very low and are not likely to cause any interference in nearby electronic equipment

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Not applicable

Voltage fluctuations / flicker emissions IEC 61000-3-3

Not applicable

The drip monitor is suitable for use in all establishments other than domestic and those connected to the public low voltage power supply network that supplies buildings used for domestic purposes.

Table 2: Guidance and Manufacturers Declaration - Electromagnetic Immunity The drip monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the drip monitor should assure that it is used in such an environment.

Immunity Test Electrostatic discharge (ESD) IEC 61000-4-2

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IEC 60601 Test level

Compliance level

Electromagnetic environment Guidance

+/- 6kV contact

+/- 6kV contact

+// 8kV air

+/- 8kV air

Floors should be wood, concrete or ceramic tile. If the floors are covered with synthetic material, the relative humidity should be at least 30%. The drip monitor rate display may clear to zero at levels above 8kV air. Do not touch the connector pins directly. The connector is marked with the symbol for ESD sensitivity (ref. IEC 60417-5134)

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Electrical fast transient burst IEC 61000-4-4

+/- 2kV for power supply lines +/- 1kV for input/ output lines

Not applicable

Surge IEC 6100-4-5

+/- 1kV differential mode +/- 2kV common mode

Not applicable

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

Not applicable

3 A/m

3 A/m

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60Hz) magnetic field IEC 61000-4-8

Not applicable

Not applicable

Not applicable Not applicable

Mains power quality should be that of a typical commercial or hospital environment. The drip monitor is not functional while mains power is connected for charging the battery.

Mains power quality should be that of a typical commercial or hospital environment. The drip monitor is not functional while mains power is connected for charging the battery.

Mains power quality should be that of a typical commercial or hospital environment. The drip monitor is not functional while mains power is connected for charging the battery.

Not applicable

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Table 3: Guidance and Manufacturers Declaration - Electromagnetic Immunity - for equipment and systems that are Life-Supporting The drip monitor is intended for use in the electromagnetic environment specified below. The customer or the user of the drip monitor should assure that it is used in such an environment.

Immunity Test

IEC 60601 Test level

Compliance level

Electromagnetic environment Guidance Portable and mobile RF communications equipment should be used no closer to any part of the drip monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

Conducted RF IEC 61000-4-6

3 Vrms 150kHz to 80MHz outside ISM bands

Not applicable, ref. EN60601-12:2001 clause 36.202.6 a)5

d=1.17√P

10 Vrms 150kHz to 80MHz in ISM bands a

Not applicable, ref. EN60601-12:2001 clause 36.202.6 a)5

d=4√P

a

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Radiated RF IEC 61000-4-3

10 V/m 80MHZ to 2.5GHz

3 V/m (3)

d=4√P 80 MHz to 800 MHz d=7.67√P 800 MHz to 2.5 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) b. Field strengths from fixed RF transmitters, as determined by an electromagnetic site c survey, should be less than the d compliance level in each frequency range . Interference may occur in the vicinity of equipment marked with the following symbol:

10 V/m (3)

The drip monitor may not operate correctly above 3 V/m. (3)

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.

Note 3

The drip monitor was designed to meet EN60601-1-2:1993 The ISM (industrial, scientific and medical) bands between 150kHz 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 40.7 MHz.

a

The compliance level 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.

b

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land 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 drip monitor is used exceeds the applicable RF compliance level above, the drip monitor should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as reorienting or relocating the drip monitor.

c

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

d

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Table 4: Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the Drip Monitor - for Life Supporting Equipment and Systems The drip monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the drip monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the drip monitor as recommended below, according to the maximum output power of the communications equipment. Separation Distance according to Frequency of Transmitter (m) Rated maximum output power of Transmitter (W)

150 kHz to 80 MHz outside ISM bands d=1.17√P

150 kHz to 80 MHz in ISM bands d=4√P

80 MHz to 800 MHz d=4√P

800 MHz to 2.5 GHz d=4√P

0.01

0.12

0.4

0.4

0.77

0.1

0.37

1.26

1.26

2.42

1

1.17

4

4

7.67

10

3.7

12.65

12.65

24.24

100

11.7

40

40

76.67

For transmitters rated at a maximum power output not listed above, the recommended separation distance d in metres (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 of the higher frequency range applies. Note 2: The ISM (industrial, scientific and medical) bands between 150kHz 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 40.7 MHz. Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas. Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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