S-1235 Operation Manual

Contact information Our authorized representative

Australia

Parker Healthcare Pty Ltd 16 Redland Drive, Mitcham, Victoria 3132, Australia Tel. : 61 3 98720222 Fax. : 61 3 9873 5911

EU countries

PHARMASERVE-LILLY S.A.C.I.

Pharmaserve-Lilly S.A.C.I 15th klm National Road Athens-Lamia, 145 64 Kifissia, Greece Post Address : P.O.Box 51288, 145 10 Kifissia, Greece Tel. : 3016294600 Fax. : 3016294610

INTRODUCTION This Operation Manual deals with the specifications, operation and maintenance of the Atom Syringe Pump S1235. Atom is by no means held responsible for any malfunction arising from a user ignoring the instructions for operation and maintenance described in this Manual as well as for any accident attributable to repair by someone other than our serviceman or a qualified repairman. Read this Manual carefully and familiarize yourself thoroughly with its contents before operating the unit. Keep this Manual where it is readily accessible for reference in case of need. If any technical problem should arise, please contact your local representative.

CAUTION This product is shipped without being disinfected. Be sure to clean and disinfect the unit before using it for the first time after purchase. Used parts and products no longer safe to use should be disinfected and/or sterilized and then disposed of as medical wastes.

Fields of use (1) Place general wards, ICUs/NICUs, ORs, etc. (2) This product can be used for accurate infusion of nutritional solutions and medical fluids to neonates including preterm neonates.

SAFETY INFORMATION Instructions to ensure the safe operation of the unit are found throughout this Manual. Please read the Manual carefully before operating the unit. Please follow the instructions in operating the unit.

[1] Basic Instructions 1. Follow the instructions for safe use of the unit. Follow the operating instructions described in this Manual for safe use of the unit. 2. Inspect the unit on a periodical basis. Periodical inspection is needed to use the unit under optimum conditions. 3. Never use the unit when faulty. If any damage or malfunction of the unit should be noticed, stop using it immediately and contact your local representative. 4. EMC (electromagnetic compatibility) Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this Manual.

[2] Definition of Warning Indication Two levels of warning indication are used throughout this Manual and on the unit. They are defined as follows: A WARNING notice indicates an indirectly (potentially) hazardous situation WARNING : which, if not avoided, will result in death or serious injury, serious damage to property such as total loss of use of equipment, and a fire.

CAUTION :

A CAUTION notice indicates a hazardous situation which, if not avoided, can result in minor or moderate injury, partial damage to property, and loss of data stored in computers.
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[3] Definition of Marks 1. Marks to indicate caution or warning Mark

Title and Indication General attention Indicates unspecified general caution or warning.

2. Marks to prohibit action Mark

Title and Indication General prohibition Indicates unspecified general prohibition. Prohibition of disassembly Indicates prohibition of disassembly of the unit where it may cause an electric shock or other hazards.

3. Marks to give instructions for action Title and Indication

Mark

General instruction Indicates unspecified general action on the part of the user. Remove the power plug from the power outlet Instructs the user to remove the power plug from the power outlet in the case of malfunction or where a thunderbolt may fall. Connect a ground wire Instructs the user to connect the ground wire without fail where the unit is provided with a ground terminal. 4. Marks to classify the unit Mark

Title and Indication Degree of protection against an electric shock Type CF equipment

IPX1

Degree of protection against harmful ingress of water Equipment protected against water dripping vertically.

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5. Other marks Mark

Title and Indication Recycle mark (battery) Recycling recommended.

Li-ion AC mark

Signal input/output A connector in which an input and an output are combined. External power source mark The LED comes on to indicate that the unit is connected to an external power source. Date of manufacture

WARRANTIES This equipment is guaranteed by Atom Medical Corporation for a period of one year from the date of delivery to be free of any defects in both materials and workmanship when used normally for its intended purpose. Any parts of this equipment proving to be so defective will be repaired or replaced at no charge during the warranty period. In the following cases, however, actual expenses need to be paid even during the warranty period. (1) Wear and tear of expendables. (2) Trouble and damage due to improper handling, such as dropping the unit during transport or transfer. (3) Trouble and damage due to a fire, salt, gas, extraordinary voltage, earthquake, thunder, storm and flood, or other natural calamities. (4) Travel expenses in the case of a trip to an isolated island, a remote place, etc. for the purpose of repair. Damage in shipment should be reported promptly to Atom accompanied by the certificate of the carrier concerned. All correspondence concerning the equipment should specify the model name and the serial number.

WARNING Atom is by no means held responsible for compensation for death, injury or damage to property if such loss should occur due to any of the following causes. 1. Trouble or damage due to installation, relocation, maintenance or repair by someone other than technical personnel belonging to Atom. 2. Trouble or damage of Atom products caused by a product of another company other than that supplied by Atom. 3. Trouble or damage due to modification, maintenance or repair using a part other than that specified by Atom. 4. Trouble or damage due to neglecting the operating precautions or operating instructions described in the Operation Manual of the unit. 5. Trouble or damage due to operation under ambient conditions, including electrical requirements and installation requirements, other than those described in the Operation Manual. 6. Trouble due to carelessness or improper modification. 7. Trouble or damage due to using secondhand equipment.
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[1] Precautions on Jamming

WARNING Medical radio knives, portable and mobile communication equipment, and other devices which generate high-frequency noise can cause jamming to various electric equipment for medical use and thus result in malfunction. Since portable and mobile communication equipment, etc. are often used in medical facilities, some measures should be taken to prevent jamming due to such devices. Portable and mobile communication equipment and other devices which generate high frequency should not be used near the unit during its operation to prevent malfunction of the unit due to jamming.

[2] Responsibility for Care of Equipment

CAUTION It is the user (a hospital, a doctor’s office, a clinic) that is responsible for the operation, maintenance and care of the electric equipment for medical use. The equipment should be used only by medical personnel.

[3] Prohibition of Modification

WARNING Do not disassemble or modify the unit. Otherwise, a fire, an electric shock or injury may result.

[4] Periodical Inspection

CAUTION Proper periodical inspection is needed to use the unit under optimum conditions.

[5] In Case of Trouble

CAUTION If any abnormal condition or trouble should occur to the unit, indicate on the unit that it is out of order and contact immediately your local representative. See the beginning of this Operation Manual for where to make contact. If any abnormal condition or trouble should occur, do not use the unit until it has been repaired completely by a service engineer so as to prevent possible danger.

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INTRODUCTION ... 1 [1] Operating Precautions 1-1. WARNING ... 6 1-2. CAUTION ... 10 [2] Description ... 12 [3] Parts Identification 3-1. Main Body ... 12 3-2. Operation Panel ... 13 3-3. Side Views of the Main Body ... 13 [4] Installation 4-1. Attaching the Mounting Table ... 14 4-2. Power Outlet and Grounding ... 15 4-3. Power Source ... 16 [5] How to use (Operation) 5-1. Preparation ... 18 5-2. Operation ... 20 5-3. Other Functions ... 27 [6] Alarm ... 33 [7] Maintenance Inspection 7-1. Inspection before Use ... 35 7-2. Monthly Inspection ... 37 7-3. Bimonthly inspection ... 38 7-4. Disinfection ... 41 7-5. Parts Requiring Periodical Replacement ... 42 7-6. Inspection Check List ... 43 7-7. How to Replace the Battery ... 44 7-8. How to Replace the Fuses ... 45 7-9. Life ... 46 7-10. Disposal ... 46 [8] Technical Data ... 47 [9] Characteristics of the Unit 9-1. Flow Rate Characteristics ... 49 9-2. Occlusion Characteristics ... 50

[1] Operating Precautions Please follow the operating instructions described in this Manual for safe use of the unit. The unit should be operated only by those who have been trained and instructed properly in its operation. The unit should be operated only for its intended use.

1-1.

WARNING

Death or serious injury due to a fire or an electric shock will result if the instructions given below are not followed.

Syringes to be used with the unit should be disposable syringes (10mL, 20mL, 30mL, 50mL) produced by the manufacturer indicated on the main body. Use of a syringe of a different manufacturer will cause an unacceptable flow rate error. Be sure to follow the doctor’s instructions in setting the flow rate (infusion rate). Never use the unit in conjunction with a gravity-type infusion using the same line. Doing so may cause improper infusion or may cause the unit to generate no alarm.

Use only the power cord supplied with the unit. Otherwise, a fire or an electric shock may result.

Avoid damaging the power cord. A damaged power cord may cause a fire or an electric shock. 쎲 Do not pinch the power cord between the unit and the wall, a shelf or the floor. 쎲 Do not place the power cord near a heating apparatus; do not heat the power cord. 쎲 Do not put anything heavy on the power cord. 쎲 Be sure to grasp the power plug with your hand to remove the power cord from the power outlet. A damaged power cord should be replaced immediately with a new one.

Be sure to insert the power plug fully into a power outlet. Incomplete insertion of the plug may cause heat to generate and a fire may result. Check the power outlet regularly to make sure that it presents no abnormality. A loose or damaged outlet can cause a poor electrical connection, which may generate heat and result in a fire. Keep the area around the power plug and power outlet free of dust. Accumulated dust on the plug can cause heat to generate and may lead to a fire. Do not touch the power plug with a wet hand. Otherwise, an electric shock may result.

Operate the unit on AC power whenever an AC outlet is available. The power outlet should be located near the unit to prevent accidental contact with a trailing power cord. Use a separate power outlet for each unit.

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Ensure that the power input terminal does not come into contact with a medical fluid or other fluids. If a medical fluid or any other fluids comes in contact with the power input terminal, wipe it off immediately, to avoid the possibility of fire.

Ground the unit securely. Otherwise, an electric shock due to current leakage may result. To complete the ground connection, connect the power cord only to a 3P power outlet including a ground terminal and grounded properly. Do not operate the unit if you have any doubt about its ground connection.

Do not use the unit in possibly flammable environment. Fire ignition or explosion could result.

Equipment generating high frequency must not be used near the unit. If equipment generating high frequency, such as medical radio knives and portable and mobile communication equipment, should be used near the unit during its operation, jamming may cause the unit to malfunction. Do not use such devices near the unit.

Do not disassemble or modify the unit. Otherwise, a fire, electric shock or injury may result.

Do not install the unit where it will be exposed to excessive humidity, dust or steam. Otherwise, a fire or an electric shock may result.

If you continue to operate the unit on the battery after a low battery alarm is given, the unit will stop operation completely in thirty minutes or so (when the battery is new). As soon as the low battery alarm is given, switch the unit to AC power. During the infusion, do not rely only on the alarm functions of the unit but keep on monitoring with your own eyes. Check the fluid level in the syringe to ensure proper operation of the unit. If the unit is going to be used with a radio knife in an operating room, etc., check the following before use. If any trouble should occur, remove the cause before operating the unit. (1) The amount of high frequency noise generated by a radio knife depends on the type of the radio knife in use. The old vacuum tube gap type, which generates much noise, must not be used with the unit. (2) The unit must be sufficiently away both from the cord of the radio knife (including the knife holder, the cord itself and the polar plate lead) and from the main body of the radio knife. (3) The power plugs of the radio knife and the unit must be connected to separate power outlets on different circuits.

Check for any abnormal conditions before starting the pump. Before pressing the [START] switch, check that no medical fluid is flowing out of the tip of the needle. If the unit is properly set up but any medical fluid is flowing out, the main body may be faulty. Stop using the unit immediately, indicate on the main body that it is out of order, and contact your local representative.

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Check for conformity to the applicable standard if the unit is going to be connected to another medical device for use as a system. Accessory equipment connected to the analogue and digital interfaces must comply with the relevant IEC standards (e.g. IEC60950 for data processing equipment). Furthermore all configurations should comply with IEC60601-1-1. But the items that are not specified as part of the system should not be connected. Anybody who connects additional equipment to the signal input or signal output configures a medical system, and therefore should make the medical system comply with the requirements of 60601-1-1 on his or her own responsibility. If in doubt, consult your local representative.

The unit cannot detect an abnormal flow rate such as an excessive infusion and an insufficient infusion. Therefore, while using the unit, periodically check that the movement of the plunger of the syringe corresponds to a preselected flow rate. The unit is not provided with an alarm function to warn the user when the I.V. needle has come off the vein and extravascular infusion has occurred. Therefore, periodically check the puncture site. Check that the plunger of the syringe is securely held by the plunger flange holder on the slider. If the plunger should be off the plunger flange holder or the flange of the syringe barrel should not be held properly by the barrel flange holder, siphoning (infusion due to a natural fall) or a back flow may result. To prevent accidents, the head between the unit and the patient connection should be minimal. The unit is designed to infuse a medical fluid into a patient by using a positive pressure. Therefore, it cannot detect any fluid leakage due to a disconnected infusion line or a damaged filter. While using the unit, periodically check the unit for any of these failures. Use of a lock-type connection for the infusion line is recommended. If the unit is used in a circuit where an excessive negative pressure can be generated, the plunger of the syringe may be dislodged from the slider of the syringe pump. This will cause a rapid infusion. Do not use the unit in a circuit where an excessive negative pressure can be generated. <Example> 쎲 in a circuit between a transcutaneous circulation support circuit and a patient 쎲 in a circuit between a blood pump for artificial dialysis and a patient Pay utmost attention even when the negative pressure is in a low level (
100mmHg).

The unit must be used within 65cm of the patient’s heart level. If occlusion should occur due to a bent tube in the infusion line, a clogged filter or a thrombus in the syringe needle, the pressure in the infusion line will rise. If the cause of the occlusion should be removed with the pressure in the infusion line increased, an excessive volume of the medical fluid will be delivered at a time to the patient. Be sure to clamp the infusion line or take some other appropriate measure before attempting to remove the cause of the occlusion.

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If there should be a gap between the flange of the syringe plunger and the slider, no infusion will occur for some time after starting the infusion even though the slider may move. After setting the syringe properly, be sure to press the [PRIME] switch and fill the infusion line to the tip with the medical fluid. This will prevent the above-mentioned gap. Never operate the unit in the area where Radiological Equipment and MRI are controlled, as well as where hyperbaric oxygen therapy is performed. Remove the unit from service immediately if it has been subjected to an impact (e.g., the pump has fallen onto the floor, or been affected by a fall of an I.V pole). The integrity of the unit should be checked and verified after such impact because the unit may be damaged inside even through its external appearance exhibits no abnormality.

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1-2.

CAUTION

Injury or damage to ambient object may result if the instructions given below are not followed.

Remove the power plug from the power outlet before moving the unit to another place or when the unit is going to be idle for a long time. Moving the unit to another place with the power plug connected to the power outlet will damage the power cord and may cause a fire or an electric shock.

Remove the power plug from the power outlet before cleaning or disinfecting the unit. Cleaning or disinfecting the unit with the power plug connected to the power outlet may cause an electric shock.

Be sure to clean and disinfect the unit before using it for the first time after purchase. Ground peripheral electric equipment securely. Place the unit on a stable surface. Placing the unit on an unstable platform or a tilted surface will cause it to fall or drop and may hurt someone. Check the strength of the place where the unit is to be placed or installed.

Install the unit out of reach of small children. Do not operate the unit covered with a cloth. Overheating may cause a fire or an electric shock.

To change the flow rate or to prime during infusion, press the [STOP] switch first to stop the infusion. The unit is provided with a safety mechanism, which does not allow the user to change the flow rate or to prime during infusion even if an appropriate switch is pressed. To stop the unit completely, press and hold the power switch for approx. three seconds to switch off the unit. Even if the power cord is removed from the power outlet with the power switch on, the internal battery will supply power and the unit will not stop operation.

The unit is provided with a self-diagnosis mechanism, which will stop the unit and give an alarm as soon as an internal failure is detected. It takes less than two seconds to detect an internal failure. (3.5mL max will be infused if the flow rate setting is 1200mL/h.) Do not drop or knock down the unit, or allow it to be struck by other objects. Do not install the unit in direct sunshine or near a heating apparatus. Do not expose the unit to extraordinary high temperature or excessive humidity.

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Do not place anything heavy on the unit. When the unit is going to be used for the first time after purchase or after lying idle for some time, connect the unit to AC power to fully charge the battery. Insufficient charging may make it impossible to operate the unit on the battery in case of a power failure.

Protect the syringe holder and the slides carefully from a shock and great force. Do not submerge the unit. The unit uses a rechargeable battery (a lithium ion battery). Before disposing of the unit, remove the lithium ion battery for recycling. Li-ion

If you have any doubt about the ground connection of the power cord, replace the power cord with a new one. If the doubt remains and yet you must use the unit, operate the unit on the battery. Bear in mind that you can operate the unit on the battery only for a limited length of time.

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[2] Description The Atom Syringe Pump S-1235, based on the internal microcomputer, is designed with safety in mind after years of our achievements which have won the confidence of our customers. Its features include thorough safety functions and the operation panel intended to prevent erroneous operation. Continuous infusion driven by the pulse motor ensures accurate infusion of nutritional solutions and medical fluids to neonates including preterm neonates with minimal malfunction. In addition, the internal rechargeable battery is conveniently provided in case of power failure or transport.

[3] Parts Identification 3-1. Main Body

w

er

t

y

!1

i

q o

No. q w e r t y

Name Operation panel Syringe holder Barrel flange holder Plunger flange detection lever Plunger flange holder Slider
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No. u i o !0 !1

!0

Name Release lever Slider cover Shock sensor Signal input/output (not for use at present) Operation indicator

u

3-2. Operation Panel

q

w

e

mL/h PRIME

!3

No. q w e r t y u

!2

!1

!0

START

o

STOP

SILENCE

i

Name LCD display Flow rate display AC power indicator [POWER] switch [CLEAR] switch Number keys [SILENCE] switch

u

No. i o !0 !1 !2 !3

7

8

9

0

4

5

6

1

2

3

C .

y

t r

Name [STOP] switch [START] switch [PRIME] switch [UP] switch [DOWN] switch [Screen Changeover] switch

3-3. Side Views of the Main Body

q u w i e

r

y

t

No. q w e r

Name Syringe holder Release lever Slider Nurse call terminal

No. t y u i

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Name Power input terminal (AC inlet) Speaker Plunger flange holder Plunger flange detection lever

[4] Installation 4-1. Attaching the Mounting Table (1) Fitting the mounting table q Holding the sub-lever in the direction of the arrow head 왗, move the lever so that the arrow head 왖 on the lever may align with the arrow head 왔 below “OPEN”. w Fit the mounting table in the bottom of the syringe pump so that the hook on the mounting table may engage with the concave portion of the bottom.

Hook

Bottom of the Syringe pump

Mounting table

e Check for proper engagement. Then, holding the sub-lever in the direction of the arrow head 왗, move the lever so that the arrow head 왖 on the lever may align with the arrow head 왔 below “LOCK”.

LOCK

OPEN

Lever

Sub-lever

(2) Turn the pole mounting lever and attach the mounting table to the I.V. pole or the bed support. The diameter of the I.V. pole or the bed support to which the mountingtable can be attached is 13-34mm.

Pole mounting lever

CAUTION The main body of the syringe pump is fixed with a rail-type locking mechanism. Attach the mounting table fixedly to the pole or the support with the pole fixing screw. If not attached fixedly, the mounting table with the syringe pump on may slide down the pole or the support. (3) Tilting the mounting table (available as an optional mount which is sold separately) Turn the tilting screw and tilt the syringe pump to a desired angle. Adjust the angle to make the LCD display easy to see.

Syringe Pump S-1235 LOCK

OPEN

Mounting table Tilting screw

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4-2. Power Outlet and Grounding

WARNING The power outlet should be located near the unit to prevent accidental contact with a trailing power cord. Use a separate power outlet for each unit. To complete the ground connection, connect the power cord only to a 3P power outlet including a ground terminal and grounded properly. Never use an additional multiple portable socket-outlet or extension cord. Do not operate the unit if you have any doubt about its ground connection. Ground peripheral electric equipment securely. The rated voltage of this unit is 220-240V~, current consumption is 0.07A, and the frequency is 50Hz. The operating voltage range is 220-240V~10%. Do not connect the unit any other power source.

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4-3. Power Source The unit operates either on AC power or on the internal battery. The unit comes from the factory without a battery loaded. Make sure to load the battery and fully charge it before use. The battery included is not charged. To load the battery, refer to the instructions in "7-7. How to Replace the Battery". 쮿 Operation on AC power (1) Connect the power cord supplied with the unit to the AC inlet (on the right side of the main body). Connect the power plug to the power outlet. The red AC power indicator above the [POWER] switch will come on to indicate that the unit is connected to AC power. The internal battery will be automatically charged while the unit is connected to AC power. (2) Press and hold the [POWER] switch on the operation panel (for at least one second) to switch on the unit. 쮿 Operation on the internal battery The unit automatically switches to battery operation if it is not connected to AC power supply or experiences power sags. A fully charged internal battery (at least ten hours of charging with the unit switched off, or at least twenty hours of charging with the unit switched on) provides about three hours of continuous operation. Fully charge the battery before operating the unit. (1) Press and hold the power switch on the operation panel (for at least one second) to switch on the unit. (2) The “ ” mark will flash in the lower right portion of the LCD display on the operation panel to indicate that the unit is operating on the battery. The battery indicator ( ) indicates how much power remains in the battery by means of four bars. As the battery loses its power during operation, the number of lit bars (max. four) decreases one by one.

Battery indicator

Operation Low battery alarm

Off

Charging

Flashing Four bars on On Flashing

Fully charged for approx. three hours of operation No battery Battery failure

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WARNING Operate the unit on AC power whenever an AC outlet is available.

It a low battery alarm is given, switch to the operation on the AC power source immediately.

CAUTION To ensure that the battery indicator reflects remaining battery power accurately: 쎲 Fully charge the battery first of all when the battery is installed. 쎲 An error may develop in the indication of remaining battery power as the cycle of charging and discharging is repeated. To prevent inaccurate indication, charge the battery to its full capacity. The battery discharges itself even when it is not used. When you are going to operate the unit on the internal battery which has been left unused for more than two weeks, be sure to off the unit and charge the battery for at least ten hours. The battery is automatically charged while the unit is operating on AC power.

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[5] How to use (Operation) 5-1. Preparation 5-1-1. Self-diagnosis function The self-diagnosis function of the unit automatically checks the internal conditions of the unit. If any fault should be detected, a message and an error code will appear on the LCD display, and an audible alarm will sound.

CAUTION If a message and an error code should appear and an audible alarm should sound in self-diagnosis, stop using the pump and contact your local representative.

5-1-2. Setting the syringe

WARNING Syringes to be used with the unit should be disposable syringes produced by the manufacturer indicated on the LCD display. To use a syringe of a different manufacturer, change the setting to select a desired manufacturer by referring to the instructions in “5-3-3. CE mode”. Use of a syringe of a manufacturer not indicated on the LCD display will cause an unacceptable flow rate error. Check that the flange of the syringe plunger is securely held by the plunger flange holder on the slider. If the flange of the plunger should be off the plunger flange holder, siphoning (infusion due to a natural fall) or a back flow may result. Check that the flange of the syringe barrel is properly held by the barrel flange holder. If the flange of the syringe barrel should be off the barrel flange holder, flow rate accuracy and alarm functions cannot be guaranteed. After setting the syringe properly, be sure to press the [PRIME] switch and fill the infusion line to the tip of the needle with the medical fluid, before sticking the needle in the patient’s arm. If there should be a gap between the flange of the syringe plunger and the slider, infusion will not start for some time. Be sure to prime the unit to make the slider press the flange of the syringe plunger. 쮿 How to set the syringe (1) Push the slider release lever and move the slider as rightward as possible. (2) Pull up the syringe holder until it can turn right and left. Turn the syringe holder either to the right or to the left so that the syringe barrel can be held by the barrel flange holder. (When turned either to the right or to the left, the syringe holder will not come down.) (3) Fill the syringe with a medical fluid and push the plunger to expel air from inside the syringe. (4) Fit the flange of the syringe barrel in the slit of the barrel flange holder.

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