FCC ID: 2A2XA-CAPS100US Amy PCA Switch

User manual for Amy PCA Switch / COOPDECH Amy PCA Contents 1. Introduction .................................................................................................................................................. 1 2. Features of the System .................................................................................................................................... 1 3. Name of each part ........................................................................................................................................... 2 4. Display ............................................................................................................................................................. 3 5. Operating the Transmitter ................................................................................................................................ 3 6. Replacement of the transmitter batteries ......................................................................................................... 4 1. Introduction This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. FCC CAUTION Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential 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 radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, 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 antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. 2. Features of the System The COOPDECH Amy PCA is set and controlled by the controller via wireless communication via Comtouch. The Amy PCA Switch also allows additional doses to be administered by the patient. 1 / 4 3. Name of each part Amy PCA Switch (CAP-S100) No. 1. Name Pilot Lamp Description Indication of operating status COOPDECH Amy PCA (CAP-D100) The higher the priority, the higher the priority.

(1) Flashing red: High priority alarm or error

(2) Lights up in orange: When a low-

priority alarm occurs

(3) Blinking green: Standby mode

(4) Red light on: Pump preparation incomplete

(when the high-priority alarm is silenced, air bubbles are detected, blockage is detected, or infusion is complete)

(5)flashing light blue: Infusion standby mode

(6) Blue light on: connected to Comtouch 2. Indicator Bumper Lock lever Release switch Pomp connector Identification switch Release hook Blockage Sensors 10. Air bubble sensor 3. 4. 5. 6. 7. 8. 9. Indication of operating status Indicator (indicating infusion in progress), Silence lamp, Alarm lamp, Battery level lamp, Power lamp and External communication unit. Bumper for shock absorption Lever for locking the pump unit after installation Switch for dismantling the pump unit Connector for applying voltage to the pump Switch for detecting the pump unit Hook for holding the pump unit Sensor for detecting blockage downstream of the infusion line Sensor for detecting air bubbles in the infusion line 2 / 4 4. Display Description No. Name 1. Indicator 2. Mute lamp Flashes during infusion. It also flashes sequentially at the same time as an infusion of 60 drops 1 ml. Lights up when the alarm sound is temporarily interrupted (muted). Red: High priority alarm silenced Orange: low priority alarm silenced 3. Alarm Lamp Flashes or lights up in the event of an alarm. 4. Battery lamp 5. Power Lamp 6. External communication part Flashes when the internal battery is operating. Depending on the remaining capacity of the internal battery, it may be green (1 to 3) or orange (1) or red (1) depending on the remaining capacity of the internal battery. Lights up when the charger is connected. Yellow when charging, green afterwards. Part for external communication 5. Operating the Transmitter Press the switch on the Amy PCA Switch to start bolus dosing. Amy PCA Switch Switch Press to start bolus dosing. 3 / 4 6. Replacement of the transmitter batteries Remove the screws, open the case lid, remove the PCB and replace the battery. 1 2 3 4 4 / 4

Label diagram Amy PCA Switch Label This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation. There is no place to paste labels into the module. So it is listed in the user manual.

COOPDECH

(4) DAIKEN M TAk w -

UL Verification Services Inc. 47173 Benicia Street, Fremont, CA 94538 Applicant: Daiken Medical Co., Ltd. FCC ID: 2A2XA-CAPS100US To whom it may concern:

We, the undersigned, hereby authorize Rie Fujiwara of Consumer Technology Division, UL Japan, Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Japan, Inc. on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. This authorization is valid until further written notice from the applicant. The application for the subject equipment has not been submitted to another TCB for certification. Ryo Takuwa Daiken Medical Co., Ltd. EDICAL CO., LTD. 2-6-2, Ayumino, Izumi-shi, Osaka, 594-1157, Japan Sincerely Yours, Letter of Authorization Date: September 13, 2021

COOPDECH Ro TkuWA. The application contains technical information which we deem to be trade secrets and proprietary. If made public, the information might be used to the disadvantage of the applicant in the market place. Thank you for your attention to this matter. UL Verification Services Inc. 47173 Benicia Street, Fremont, CA 94538 Applicant: Daiken Medical Co., Ltd. FCCID :2A2XA-CAPS100US To whom it may concern:

Please be advised that the following information is to be held confidential on behalf of us, referring to the FCC rules 0.457 and 0.459:

Block Diagram Theory of Operation Schematics Parts List Ryo akuwa Daiken Medical Co., Ltd. DAIKEN EDICAL LID. 2-6-2, Ayumino, Izumi-shi, Osaka, 594-1157, Japan Request for Confidentiality Date: September 13, 2021

COOPDECH TA UWA The application contains technical information, which we deem to be trade secrets and proprietary. If made public, the information might be used to the disadvantage of the applicant in the market place. Thank you for your attention to this matter. External Photos Internal Photos Test Setup Photos User Manual UL Verification Services Inc. 47173 Benicia Street, Fremont, CA 94538 FCCID : 2A2XA-CAPS100US Applicant: Daiken Medical Co., Ltd. To whom it may concern:

Please be advised that the following information is to be held in confidence for 180 days from the date of the Grant of Equipment Authorization and behalf of us, referring to the FCC rules 0.457 and 0.459:

RyoT wa Daiken Medical Co., Ltd. DAIKEN MEDICAL CO., LTD. 2-6-2, Ayumino, Izumi-shi, Osaka, 594-1157, Japan Request for Short-Term Confidentiality Date: September 13, 2021